protocol analysis case study

Case Study Protocol for the Analysis of Sustainable Business Models

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• Joaquin Sanchez-Planelles 3 &
• Marival Segarra-Oña 3  

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This paper is encompassed in the process of the development of a theory about sustainability. Our aim is to present a case study protocol for performing multiple-case studies about corporate sustainability. It has been designed according to the methodology about case study research. It includes a combination of frameworks that will help researchers to draw and understand how sustainability is integrated through the value chain of the company, and it also has a set of questions that will help to know the environmental practices that the target company deploys from a strategic point of view to the most common operations. Finally, once all the information has been retrieved, it will be possible to identify the way that value generated by sustainability practices flows through the company’s activities and the way customers perceive it.

• Sustainability
• Sustainable business model
• Case study research

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Bengtsson, M. (2016). How to plan and perform a qualitative study using content analysis. NursingPlus Open, 2 (2016), 8–14.

Article   Google Scholar  

Bocken, N., Short, S., Rana, P., & Evans, S. (2013). A value mapping tool for sustainable business modelling. Corporate Governance, 13 (5), 482–497.

Bower, J. L. (1986). Managing the resource allocation process: A study of corporate planning and investment . Harvard Business School Press.

Google Scholar  

Carlile, P., & Christensen, C. (2005). The cycles of theory building in management research.

Chairul, F. (2019). Business development of coffee farmers group using triple layered business model canvas. GATR Journals, Global Academy of Training and Research (GATR) Enterprise . https://EconPapers.repec.org/RePEc:gtr:gatrjs:jber182 .

Cheng, C. C. J., Yang, C.-L., & Sheu, C. (2014). The link between eco-innovation and business performance: A Taiwanese industry context.

Christensen, C., & Johnson, M. (2009). What are business models, and how are they built? Harvard Business School Module Note 610–019, August 2009. (Revised May 2016).

Downe-Wambolt, B. (1992). Content analysis: Method, applications and issues. Health Care for Women International, 13, 313–321.

Eccles, R. G., Ioannou, I., & Serafeim, G. (2014). The impact of corporate sustainability on organizational processes and performance. Management Science, 60 (11), 2835–2857.

Esty, D. C., & Winston, A. S. (2006). Green to gold: How smart companies use environmental strategy to innovate, create value, and build competitive advantage . Yale University Press.

França, C. L., Bromana, G., Karl-Henrik, R., Basile, B., & Trygg, L. (2016). An approach to business model innovation and design for strategic sustainable development. Journal of Cleaner Production, 140 (Part 1), 155–166.

Freeman, R. E. (1984). Strategic management: A stakeholder approach . Pitman.

Guinee, J. B. (2002). Handbook on life cycle assessment operational guide to the ISO standards. International Journal of Life Cycle Assessment, 7, 311.

Hillebrand, B., Kok, R., & Biemans, W. G. (2001). Theory-testing using case studies: A comment on Johnston, Leach, and Liu. Industrial Marketing Management, 30, 651–657.

Ioannou, I., & Serafeim, G. (2019). Corporate sustainability: A strategy? (January 1, 2019). Harvard Business School Accounting & Management Unit Working Paper No. 19–065.

Johnston, W. J., Leach, M. P., & Liu, A. H. (1999). Theory testing using case studies in business-to-business research. Industrial Marketing Management, 28, 201–213.

Joyce, A., & Paquin, R. (2016). The triple layered business model canvas: A tool to design more sustainable business models. Journal of Cleaner Production, 135 (2016), 1474–1486.

Krippendorff, K. (2004). Content analysis: An introduction to its methodology . Sage.

Myers, M. D. (2013). Qualitative research in business & management (2nd ed.). Sage.

Nidumolu, R., Prahalad, C. K., & Rangaswami, M. R. (2009). Why sustainability is now the key driver of innovation. In Harvard Business Review September Issue .

Osterwalder, A., & Pigneur, Y. (2010). Business model generation: A handbook for visionaries, game changers, and challengers . Wiley.

Patton, M. Q. (1990). Qualitative evaluation and research methods . Sage.

Porter, M. E. (1985). Competitive advantage. Creating and sustaining superior performance (p. 557). Free Press.

Porter, M. E., & Kramer, M. R. (2011, January–February). Creating shared value. Harvard Business Review, 89 (1–2), 62–77.

Rodríguez-Vilá, O., & Bharadwaj, S. (2017, September–October). Competing on social purpose. Harvard Business Review .

Sanchez-Planelles, J., & Segarra-Oña, M. (2019a). Conference paper: Modelos de negocio sostenibles y su implementación en el mercado. II Congreso Iberoamericano AJICEDE. Valencia, 28–29th November.

Sanchez-Planelles, J., & Segarra-Oña, M. (2019b). Reshaping Business Models with an Environmental Perspective. Corporate Social Responsibility in the Manufacturing and Services Sectors, EcoProduction. Springer Nature 2019.

Sanchez-Planelles, J., & Segarra-Oña, M. Conference paper: Modelos de negocio sostenibles y su implementación en el mercado. II Congreso Iberoamericano AJICEDE. Valencia, 28–29th November.

Sanchez-Planelles, J., Segarra-Oña, M., & Peiro-Signes, A. (2021). Building a Theoretical Framework for Corporate Sustainability. Sustainability , 13 (1), 273.

Schaltegger, S., Hansen, E., & Lüdeke-Freund, F. (2016). Business models for sustainability: Origins, present research, and future avenues. Organization & Environment., 29, 3–10.

Secretaría Técnica del Laboratorio de Ecoinnovación. (2016). Informe deTendencias #1: Modelos de Negocio Ecoinnovadores. Available from https://www.laboratorioecoinnovacion.com/informes_de_tendencias .

Segarra Oña, M., Merello Giménez, P., Segura Maroto, M., Peiró Signes, A., & Maroto Álvarez, M. (2012). Proactividad medioambiental en la empresa: Clasificación empírica y determinación de aspectos clave. Tec Empresarial, 6 (1), 35–48.

Segarra-Oña, M., Peiró-Signes, A., Mondéjar-Jiménez, J., & Sáez-Martínez, F. J. (2016). Friendly environmental policies implementation within the company: An ESG ratings analysis and its applicability to companies environmental performance enhancement. Global NEST Journal, 18 (4), 885–893.

Steckler, A., McLeroy, K. R., Bird, S. T., & McCormick, L. (1992). Toward integrating qualitative and quantitative methods: An introduction. Health Education Quarterly, 19 (1), 1–8.

Walsham, G. (2006). Doing interpretive research. European Journal of Information Systems, 15, 320–330.

Wohlin, C. (2014). Guidelines for snowballing in systematic literature studies and a replication in software engineering. In EASE ‘14.

Yin, R. (1993). K Applications of case study research . Sage.

Yin, R. K. (2013). Validity and generalization in future case study evaluations. Evaluation, 19 (3), 321–332. https://doi.org/10.1177/1356389013497081 .

Yin, R. K. (2003). Case study research: Design and methods . Sage.

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Acknowledgements

We acknowledge Mr. Elías Amor Montiel from the ESG Department of Consum for his help and collaboration in the interview and providing us with data.

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Joaquin Sanchez-Planelles & Marival Segarra-Oña

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Correspondence to Joaquin Sanchez-Planelles .

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University of West Attica, Athens, Greece

Vicky Katsoni

University of South Africa, Pretoria, South Africa

Ciná van Zyl

Questions about Holistic Sustainability

Checking the company’s sustainable policies against these questions will allow to identify how board members deal with the subject matter and know what kind of strategies is executing the company.

Question 1: What motivated the company to become sustainable? What is the company’s purpose?

Source of data:

CEO (Chief Executive Officer)

CSO (Chief Strategy Officer)

CSO (Chief Sustainability Officer)

Sample strategies :

Mission, vision and values statements from website.

Media press.

Question 2: How is the market dealing with sustainability? Is this company a leader, follower or laggard on the implementation of sustainable practices?

Product manager

Product manager assistant

Sales manager

Products portfolio

List the direct competitors of the company.

Identify which attributes about sustainability their products have.

Identify which attributes about sustainability those companies have.

Gather data about when sustainable practices were announced by direct competitors in order to determine which one is the leader, follower and laggard.

Question 3: Analysis of the influence of sustainability in the decision-making process. Are environmental criteria taken into account during the decision-making process? List the environmental criteria used for the decision-making process. Is the company’s statement about sustainability aligned with the decision-making process?

Identify the decision-making process established by the board members of the company.

Estimate how much environmental concerns are taken into consideration during the decision-making process.

Create a framework or diagram of the decision-making process.

Question 4: What is the process for detecting market needs focused on sustainable attributes?

CMO (Chief Marketing Officer)

Sales Manager

Identify if there is a department focused on detecting market trends.

Gather data about providers that offer services related to markets analysis, consumer studies, etc.

Question 5: Analysis of the relationship with stakeholders and the influence of sustainability in the relationship between company and stakeholders.

Determine what kind of relationships has the company with:

Capital market

Networks and associations

Policymakers

Business partners

Local stakeholders

Civil society and NGO’s

Question 6: Identify if the company’s board members establish environmental goals for the short, medium and long term.

UN Sustainable Development Goals

Materiality matrix

Questions about Sustainable Business Models:

Checking the company’s business model against these questions will allow to identify how the company creates superior value to customers improving the society and reducing the environmental impact.

Question 7: Identify which activities generate value through sustainability and determine flows of value through activities.

Draw the Porter’s value chain and complete each activity

Draw the value flows between activities from the value chain.

Question 8: Classify the sustainable business model developed by the company: circular economy, sustainable production, servitisation and sustainable consumption.

Draw the flows of inputs and outputs that take part in the business.

Create an organisational chart of the company that shows the different business lines and possible sustainable business models within the company (e.g. circular economy procedures to revalorise waste).

Whom does the business model supervise?

What customer segment does the business model target? Is it targeting external or internal customers?

Question 9: Are eco-friendly products and/or services addressed to a specific market niche or are they launched to broad customer segments?

Reports about the market sector.

News or press notes published in mass media.

Question 10: How does the company informs or communicates the sustainable practices to customers, users and other groups of interest?

Chief of Staff

Identify the channels used to deliver information: videos, seminars, conferences, online courses, short sessions, etc.

Question 11: Does the company consider the degree of sustainability of its providers or partners? If does, what are those criteria?

Purchasing manager

Identify the most key partners and providers of the company.

Examine what criteria o requirements need to be matched in order to work with the company. For instance: ISO 14001, EMAS, green certificates, eco certificates, etc.

Questions about Sustainable Operations.

Checking the company’s operations against these questions will allow to identify how business processes from the operational level might reduce the environmental impact.

Question 12: List the products and/or services which incorporate eco-innovative attributes.

Draw a chart with the products and services managed by business line.

Retrieve information about eco-innovative technologies and practices developed for the last three years.

Check the eco-innovative practices that have been integrated in the company’s products or services.

Question 13: What decision-making process or criteria is considered by the company to invest resources in the development and release of eco-innovative products / services?

R&D manager

Retrieve information about eco-innovative technologies and practices developed for the last three years and identify characteristics which are similar between each other.

Identification of the customers’ needs that try to solve the eco-innovative products / services.

Question 14: Identify the business areas that create value through sustainable activities.

Complete the business model canvas (Osterwalder & Pigneur, 2010 ).

Complete the triple-layered business model canvas (Joyce & Paquin, 2016 ).

Question 15: Are the channels to deliver products and services to your customers sustainable?

CLO (Chief Logistics Officer)

Identify the channels used to deliver products and services to customers: vehicle fleet, logistics, shops, offices, stores, etc.

Identify which eco-innovations or sustainable practices have been implemented in each channel. For instance, energy efficiency processes in cooling systems, eco-innovative trucks, etc.

Question 16: Have the company implemented any measure to reduce the environmental impact of its assets? For instance, energy efficiency measures in offices and production plants, emissions-reduction devices, etc.

Production Manager

Chief of Maintenance

Identify the strategic assets of the company. For instance, production centre, factory, stores, shops, offices, vehicle fleets, fields, etc.

Examine what environmental improvements have been implemented recently in the facilities and assets. For instance, acquisitions of eco-innovative production systems, installation of solar panels, implementation of sustainable architecture principles in the company’s buildings, etc.

Questions about Sustainable Methodologies.

These questions will show if methodologies designed for implementing sustainable practices among companies are widely used by managers and which of them are the most commonly applied.

Question 17: Identify if the company has any green certificate (e.g. ISO 14,001, EMAS, BREAM, Ecologic label, etc.) or if it is working to achieve one.

Information retrieved from website.

Question 18: Examine if the company works with any international standard to report its sustainable practices.

Some of the most common international standards for measuring the implementation of sustainable practices are:

GRI (Global Reporting Initiative)

Rainforest Alliance

Question 19: Did the company use any framework or methodology to implement sustainable practices?

Some of the most common sustainable methodologies and frameworks are:

Triple-Layered Canvas

Framework for Strategic Sustainable Development

Shareholder-value framework

Value Mapping Tool

Questions about the Evolution of the Corporate Sustainability.

This question will classify the company in the stage of the corporate sustainability evolution and will enlighten the potential practices that might be deployed in order to move forward to a sustainable business model or a new business platform.

Question 20: According to the different stages of the corporate sustainability evolution, in which stage does the company fit?

Sustainability memories of the company.

Classify the company according to the following corporate sustainability stages:

Sustainable Value Chain

Eco-innovative practices

Sustainable Business Model

New business platforms

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Sanchez-Planelles, J., Segarra-Oña, M. (2021). Case Study Protocol for the Analysis of Sustainable Business Models. In: Katsoni, V., van Zyl, C. (eds) Culture and Tourism in a Smart, Globalized, and Sustainable World. Springer Proceedings in Business and Economics. Springer, Cham. https://doi.org/10.1007/978-3-030-72469-6_10

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Article Contents

Introduction, contents of a research study protocol, conflict of interest statement, how to write a research study protocol.

• Article contents
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• Supplementary Data

Julien Al Shakarchi, How to write a research study protocol, Journal of Surgical Protocols and Research Methodologies , Volume 2022, Issue 1, January 2022, snab008, https://doi.org/10.1093/jsprm/snab008

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A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort. In this paper, we will describe how to write a research study protocol.

A study protocol is an essential part of a research project. It describes the study in detail to allow all members of the team to know and adhere to the steps of the methodology. Most funders, such as the NHS Health Research Authority in the United Kingdom, encourage researchers to publish their study protocols to create a record of the methodology, help with publication of the study and reduce duplication of research effort. In this paper, we will explain how to write a research protocol by describing what should be included.

Introduction

The introduction is vital in setting the need for the planned research and the context of the current evidence. It should be supported by a background to the topic with appropriate references to the literature. A thorough review of the available evidence is expected to document the need for the planned research. This should be followed by a brief description of the study and the target population. A clear explanation for the rationale of the project is also expected to describe the research question and justify the need of the study.

Methods and analysis

A suitable study design and methodology should be chosen to reflect the aims of the research. This section should explain the study design: single centre or multicentre, retrospective or prospective, controlled or uncontrolled, randomised or not, and observational or experimental. Efforts should be made to explain why that particular design has been chosen. The studied population should be clearly defined with inclusion and exclusion criteria. These criteria will define the characteristics of the population the study is proposing to investigate and therefore outline the applicability to the reader. The size of the sample should be calculated with a power calculation if possible.

The protocol should describe the screening process about how, when and where patients will be recruited in the process. In the setting of a multicentre study, each participating unit should adhere to the same recruiting model or the differences should be described in the protocol. Informed consent must be obtained prior to any individual participating in the study. The protocol should fully describe the process of gaining informed consent that should include a patient information sheet and assessment of his or her capacity.

The intervention should be described in sufficient detail to allow an external individual or group to replicate the study. The differences in any changes of routine care should be explained. The primary and secondary outcomes should be clearly defined and an explanation of their clinical relevance is recommended. Data collection methods should be described in detail as well as where the data will be kept secured. Analysis of the data should be explained with clear statistical methods. There should also be plans on how any reported adverse events and other unintended effects of trial interventions or trial conduct will be reported, collected and managed.

Ethics and dissemination

A clear explanation of the risk and benefits to the participants should be included as well as addressing any specific ethical considerations. The protocol should clearly state the approvals the research has gained and the minimum expected would be ethical and local research approvals. For multicentre studies, the protocol should also include a statement of how the protocol is in line with requirements to gain approval to conduct the study at each proposed sites.

It is essential to comment on how personal information about potential and enrolled participants will be collected, shared and maintained in order to protect confidentiality. This part of the protocol should also state who owns the data arising from the study and for how long the data will be stored. It should explain that on completion of the study, the data will be analysed and a final study report will be written. We would advise to explain if there are any plans to notify the participants of the outcome of the study, either by provision of the publication or via another form of communication.

The authorship of any publication should have transparent and fair criteria, which should be described in this section of the protocol. By doing so, it will resolve any issues arising at the publication stage.

Funding statement

It is important to explain who are the sponsors and funders of the study. It should clarify the involvement and potential influence of any party. The sponsor is defined as the institution or organisation assuming overall responsibility for the study. Identification of the study sponsor provides transparency and accountability. The protocol should explicitly outline the roles and responsibilities of any funder(s) in study design, data analysis and interpretation, manuscript writing and dissemination of results. Any competing interests of the investigators should also be stated in this section.

A study protocol is an important document that specifies the research plan for a clinical study. It should be written in detail and researchers should aim to publish their study protocols as it is encouraged by many funders. The spirit 2013 statement provides a useful checklist on what should be included in a research protocol [ 1 ]. In this paper, we have explained a straightforward approach to writing a research study protocol.

None declared.

Chan   A-W , Tetzlaff   JM , Gøtzsche   PC , Altman   DG , Mann   H , Berlin   J , et al.    SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials . BMJ   2013 ; 346 : e7586 .

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• v.5(1); 2021

A protocol for retrospective translational science case studies of health interventions

Sara e. dodson.

1 Office of Science Policy and Planning, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA

2 Office of Evaluation, Performance and Reporting, Division of Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA

Linda Scholl

3 Office of Applied Scholarship and Education Science, Mayo Clinic College of Medicine and Science, Rochester, MN, USA

Clara M. Pelfrey

4 Clinical and Translational Science Collaborative, Case Western Reserve University, Cleveland, OH, USA

William M. Trochim

5 Clinical and Translational Science Center, Weill Cornell Medicine, Cornell University, New York, NY, USA

Associated Data

For supplementary material accompanying this paper visit https://doi.org/10.1017/cts.2020.514.

The critical processes driving successful research translation remain understudied. We describe a mixed-method case study protocol for analyzing translational research that has led to the successful development and implementation of innovative health interventions. An overarching goal of these case studies is to describe systematically the chain of events between basic, fundamental scientific discoveries and the adoption of evidence-based health applications, including description of varied, long-term impacts. The case study approach isolates many of the key factors that enable the successful translation of research into practice and provides compelling evidence connecting the intervention to measurable changes in health and medical practice, public health outcomes, and other broader societal impacts. The goal of disseminating this protocol is to systematize a rigorous approach, which can enhance reproducibility, promote the development of a large collection of comparable studies, and enable cross-case analyses. This approach, an application of the “science of translational science,” will lead to a better understanding of key research process markers, timelines, and potential points of leverage for intervention that may help facilitate decisions, processes, and policies to speed the sustainable translational process. Case studies are effective communication vehicles to demonstrate both accountability and the impacts of the public’s investment in research.

Introduction

The science of translational science seeks to understand the scientific and operational principles underlying each step of the translational research process [ 1 ]. While the translational process is not linear, several distinct phases of research are typically operationalized, for example, basic, preclinical, clinical, clinical implementation, and public health research, with critical translation efforts required to move knowledge between each phase. To systematically assess the complex translational process, several promising formative and summative research evaluation approaches, including quantitative, qualitative, and mixed methodologies, have been developed in recent years [ 2 , 3 ]. Case studies frequently are used as tools for research evaluation because they provide a rigorous way to explain understudied practices, and they are an effective mechanism for identifying long-term outcomes of scientific research [ 4 – 7 ]. In addition, researchers who study the key processes and outcomes of scientific endeavors are continually refining frameworks for assessing scientific research impact [ 6 , 8 – 14 ].

A systematic translational science case study approach is currently lacking. This article fills this gap by providing a specific protocol for conducting case studies to evaluate the translational research processes underlying the development of successful health interventions. This protocol allows researchers to apply a common approach and generate comparable insights. The authors recommend Robert Yin’s textbook “Case Study Research and Applications: Design and Methods” for a full exploration of the theoretical foundations of the case study methodology [ 15 ]. Yin describes how case studies are an excellent evaluation tool as they allow for the combined use of qualitative and quantitative data, providing an in-depth examination of the factors that contributed to the success of specific research activities, as well as factors that may hinder success [ 15 – 18 ]. The process of conducting case studies requires an open and flexible approach that is driven by the unique case being studied. Case studies can capture a wide variety of impacts, including the unexpected, and can provide context about the evolution of research that may not be apparent in a review of outcomes. Case studies are particularly valuable in describing whether and how certain activities and contributors were pivotal in advancing science and improving public health outcomes [ 6 , 19 ]. Translational case study researchers often face the challenge of keeping the case focused on a specific and time-bound translational intervention and its evolution. Case study researchers must continually make decisions about which elements are and are not fundamental to the story.

Case studies, like all methodologies, have limitations. Results from a single case may not be generalizable [ 18 ]. Our case study protocol is not meant to cover the full scope of a research program, but rather to capture the central elements in the discovery and development of a specific health intervention. As such, it may potentially filter out aspects of a larger field of research in which the case is situated. In addition, case studies are data-intensive, time-consuming, require expert input to highlight the most important factors, and are susceptible to subjective interpretation [ 20 ]. Despite such limitations, case studies are arguably the most comprehensive way to study complex systems.

The sections below provide guidance on selecting cases for study; the key elements, themes, and analyses that are needed to develop the cases; as well as methods and data sources useful in conducting case studies. We encourage adoption of this protocol by diverse researchers working in any number of fields who focus on understanding the scientific process and research outcomes. The case study approach is most effective when findings are made accessible to broad communities, in particular because successful translation is often impeded by a lack of common vernacular between research disciplines, practice communities, and policymakers. Ultimately, the goal is to develop a collection of comparably-conducted case studies, enabling cross-case analyses that could inform the “science of translational science” to address questions such as: What processes tend to drive translation forward and in which contexts? What challenges can be anticipated with particular types of research studies? How can such challenges be addressed early to avoid delays in successful implementation? How can resources from research institutions and funders be directed to maximally support translational research efforts?

Translational Case Study Protocol

Case selection.

Appropriate case types include evidence-based interventions which have generated discernible health impacts, such as a specific technology, diagnostic, preventive, drug, device, biologic, behavioral intervention, or other treatment strategy. Cases should be examples of successful translation across the full continuum of research to practice, where the generation of knowledge falls within a definable range between inception of the intervention and its impacts . The selected intervention should be currently in use in medical or public health settings and there should be evidence that the intervention improves health outcomes, increases life expectancy, and/or improves individuals’ quality of life.

Case studies of research translation that have not progressed yet to impact, but which show strong potential for future impact, are also valuable, as are studies that examine “unsuccessful” aspects of research translation. However, unsuccessful research is much harder to study because there are very few negative studies published, and researchers are reluctant to highlight their failures. While this protocol may be adapted to the study of partial and not-yet-successful research translation efforts, the focus here is on the assessment of interventions that have been successfully implemented into practice.

Case Study Elements

The case study consists of two central elements: (1) a detailed timeline of the major events and milestones that marked the translational progress, and (2) a broader narrative that describes how and why such progress happened. The timeline and narrative should complement each other and contain overlapping content. Both should include detailed documentation of sources that support the central elements. A more detailed description of the translational case study elements is presented in Appendix A (in Supplementary Material).

The case study timeline

Case studies should include a timeline, or multiple interconnected timelines where warranted, which serves as a key graphic for organizing and communicating the case’s central information. The timeline is a universally understood device for visualizing temporal translational progression, for example, “distance” between milestones and complex cause and effect relationships. The timeline progresses in phases along one or more pathways and is punctuated by multiple milestones that help to anchor the case study’s chronological story. While timelines are typically linear, we recognize that the translational process often moves backward and forward through different phases and may have parallel storylines. A timeline is particularly effective for describing such parallel storylines and illustrating critical points of convergence and divergence. Organizing elements of the timeline include the following:

• 1. Start and end points of case study : Translational case studies link the chain of evidence from scientific observations to verifiable impacts of the intervention on health. The discreet start and end points of the case should be identified and a rationale for why those points were chosen should be presented. See Appendix A for a detailed discussion and guiding questions on how to select appropriate start and end points. Briefly, selecting the most relevant and appropriate start and end points for any translational case will be subjective and may be challenging. The start point is typically defined as the inception of the particular innovation being described in the case study and its association with a “target” such as a disease or diagnosis. Discussion of the start point chosen for the case study may point to foundational research knowledge that was essential for conceptualizing an effective intervention, perhaps going back decades or more in the research literature. The case study should address how far into practice the intervention has gone and the end point should represent a concrete outcome that has taken place in medical or public health practice. Outcomes may include how the intervention was implemented or otherwise “packaged” for scaling up. If the intervention is a drug, device, or biologic, evidence of adoption into practice should be included, if available. The development and adoption of an intervention in clinical and community settings may continue to evolve far beyond the chosen end point of the case study. When relevant, the start and end points need to be described in the larger context of scientific progress and may require additional relevant historical, social, and political context.
• 2. Progress markers/milestones : Markers or milestones are integrally related to key events that occur during the translational process, including the start and end points of study [ 21 ]. Markers are anchored on specific dates and can be represented as points or intervals on a timeline. Markers should be chosen for their ability to help tell the story of the development and translation of the intervention. Different types of markers include the following: (1) major inputs – resources, human and intellectual capital, and so on; (2) key activities and events – major meetings, formation of a collaboration or partnership, serendipitous events, interim research milestones, and so on; and (3) major products or outputs – presentations, publications, clinical trials results, drug approvals, markers of commercialization, changes in practice, changes in public health measures, and any other evidence of adoption of the intervention into practice.
• 3. Translational phases : It is useful to group a complex translational timeline visually into general research phases. Numerous similar multiphase schemes of translation have been proposed, but there is currently no universally accepted typology [ 21 ]. One model for these case studies is the National Institutes of Health (NIH) National Center for Advancing Translational Sciences’ translational phase model [ 22 ], which includes the following research phases: basic, preclinical, clinical, clinical implementation, and public health. Another useful translational research framework comes from the NIH’s National Institute of Environmental Health Sciences (NIEHS) [ 23 ]. The NIEHS framework was developed specifically to aid researchers in describing the evolution of their translational research in the area of environmental health. See Appendix B (in Supplementary Material) for suggested definitions and parameters for delineating research phases. Depending on the case, it may be necessary to apply a different translational model; however, whatever schema is used, it should clearly identify the markers and milestones that distinguish each phase. Well-written case studies should help reveal where there are intersecting points and gray areas between the discrete phases.

The case study narrative

The second central element of the case study is the narrative, which provides a coherent summary that moves the reader through the translational science process, describing the major actors, themes, forces, pivotal events, and advances that influenced the translational process. The narrative should focus on describing how and why the intervention developed as it did, how and why the markers/milestones were achieved, as well as what challenges were encountered and how those challenges were addressed. These drivers of translation may arise directly from key documents and/or interviews with the central researchers and stakeholders (e.g., funders, community advocates, or practitioners). They may also arise indirectly through an analysis of the information gathered throughout the course of researching the case study. Given the interdisciplinary nature of translational research, the narrative should avoid discipline-specific jargon and instead should use easily understood language. In addition, case study authors may want to consider writing the narrative for different target audiences, including a lay audience (see section “Formats of Finalized Case Study Materials” for a broader discussion of case study audiences and formats).

The case study narrative key elements

• 1. Health problem and relevance of the intervention : The case study narrative should begin with: (a) background on the relevant disease(s), disorder(s), or public health challenge(s), including some measure(s) of burden to help communicate the scope of the problem; (b) a description of the intervention; (c) relevant historical, social, and political context; and (d) a brief summary of the impact.
• 2. Key events: The key events are the scaffolding of the case study narrative and often correspond with the timeline progress markers/milestones, including the start and end points. They constitute the heart of the chronological story, describing the sequence of integral events.
• 3. Key people and partnerships : Over the course of translating an intervention from inception to impact, there are many individuals and groups who play important roles in the research progress. In a case study, determining which key actors are discussed, and why, requires careful judgment and should be backed by objective evidence. The case study should highlight individuals and sectors across the health research and practice ecosystem. This should include the central researchers and teams as well as those who were integral in disseminating and implementing the intervention, in the commercial or nonprofit development of the intervention, and in enabling broad uptake and adoption of the intervention. In addition, there should be a description of how and why different individuals collaborated with each other and what role those collaborations played in the development and implementation of the intervention. Collaborative relationships are often influenced by surrounding organizational culture(s) in ways that may be conducive or disruptive to the success of collaborative research endeavors. Where relevant, consider examining the characteristics of the organizational climate that helped create and support key collaborations.
• 4. Other influencing factors: There are many other factors that can influence a translational research process. Case studies should include descriptions of major facilitators and barriers, both expected and unexpected. Facilitators may include critical support and infrastructure; influential policies; transformative technologies, tools, and techniques; and knowledge or strategies borrowed from tangential lines of research. Major barriers or challenges should also be described, including failed or abandoned research directions, and how those difficulties were overcome. In addition, there may be critical contextual factors that influenced translational progress, such as historical, political, and other social events or changes. Well-designed interview questions are particularly useful to draw out influential factors that may not be obvious to those centrally involved in the research nor readily apparent from records and other archival materials.

Impacts will rarely be fully attributable to the case study; in most cases, they will be influenced by many additional moderating factors not covered in the study. Therefore, case study researchers should avoid “over-crediting” their findings, and should provide compelling evidence that the central factors identified have played a critical role.

• 6. Further developments : Case study narratives should conclude with a description of how the research, dissemination, and/or implementation is currently progressing (or could progress); analysis of the remaining knowledge gaps and work that still needs to be done; and/or any important postscripts to the case study.

Translational Case Study Methodology

The methodology for conducting a case study is an iterative process that progressively fills in the case details until no significant additional factors emerge. The methodology described here builds on research approaches used by social scientists, political scientists, historians, and even criminal investigators and investigative journalists. These approaches involve skills that include objectivity, analytical skills, interviewing skills, using mixed-methods, doing literature searches, consulting multiple data sources, and constructing a narrative. The list of methodological steps provided below is not intended to be strictly linear; steps can be revisited as information accumulates. For example, while most case studies will begin with defining the start and end points, these are likely to be revised over time as new information and insights arise. This iterative process allows the timeline to be a key methodological tool to tell the narrative and to identify remaining knowledge gaps.

Methodological steps may include the following:

• a. background on health issue/disease being addressed;
• b. background on key researchers and research team(s);
• c. information about the development, testing, and implementation of the intervention, including key process markers (grants, FDA approvals, clinical trials, patents, publications, research syntheses/meta-analyses, recommendations/guidelines); and
• d. evidence of accrued or potential impacts. Useful information gathering approaches include web searches (including websites maintained by research funders, news media, researchers, industry, health/patient advocacy organizations, professional societies, and so on), literature searches, and other database searches (e.g., for relevant grants, patents, clinical trials, population health data).
• 2. Create an initial timeline, identifying start and end points and chronologically mapping the progress markers in the translational research process.
• 3. Identify initial gaps in data/information.
• 4. Identify an initial list of key stakeholders, including individuals responsible for translational research progress, as well as others who may have strong historical perspective and subject matter knowledge.
• 5. Conduct semistructured interviews with selected stakeholders.
• 6. Continue gathering data until no significant additional details or factors emerge.
• 7. Return case study analyses back to interviewees/key stakeholders to validate and ensure accuracy and completeness.

Retrospective translational case study reporting template outline, which can be used as a guide when writing up a case study.

Data analysis will use a variety of appropriate quantitative and qualitative techniques, which may include:

Record review : A variety of records can be used to stitch together the timeline and narrative, including primary and secondary research literature; grant records; press releases and other media items; policy statements; legal and regulatory documents; program and service development announcements; clinical trials; changes in clinical practice guidelines; FDA approvals; patent records; and health service research findings. Often, research and review articles written by the developers of the intervention can be a valuable resource. However, care should be taken to avoid biasing the story toward certain research teams over other potentially pivotal contributors.

Interviews with key researchers and other stakeholders are critical for the verification of timeline and story, the identification of central themes and key contextual factors such as facilitators and barriers, and for filling in gaps in the story. Relevant stakeholders include research investigators and trainees, organizational leaders, health and medical practitioners, community health advocates, and patients. The process of conducting semistructured interviews is at the heart of the case study. Wherever possible, it is helpful to develop multiple independent corroborating interviews. Most stakeholders will agree about what the key markers/milestones were; however, there may be competing and irreconcilable stories about how the case evolved. In that situation, alternative stories should be noted rather than forced into a single coherent interpretation. See Appendix C (in Supplementary Material) for key themes to guide the interview and sample interview questions; however, interview guides should be tailored to the case and interviewee. In particular, question probes can be very helpful in encouraging interviewees to place their efforts, understanding, and opinions within the broader context.

Bibliographic, bibliometric, and grant portfolio analyses should be used as a rigorous and data-driven approach to identify and validate translational research milestones, central researchers and research funders, levels of research funding, and influential research collaborations. Case study researchers should consider applying these approaches to identify different inputs (such as funding, time, human capital, research infrastructure, equipment/technology, other research resources, and/or partners) as well as different outputs (knowledge generated, patents generated, etc.) that were critical for development of long-term outcomes. A detailed examination of research grant records can provide valuable information on key resources and pivotal research funders. Both the NIH RePORTER webtool [ 25 ] and the Federal RePORTER webtool are searchable databases of scientific awards from several federal agencies [ 25 , 26 ].

Relevant to measuring research outputs, bibliometric approaches include several techniques for assessing the quantity, extent of dissemination, and content of publications and patents [ 2 ]. For example, bibliographic analysis from an identified clinical trial, grant, or seminal publication can be used to indicate the number of times an article has been cited and in what topic area. The pattern of citations can show the influence of key publications and help provide evidence of knowledge links over time. Network analyses of publication citations can reveal key researchers/research teams, findings, and collaborations. A valuable free bibliometric tool for conducting translational case studies is the “Translational Module” in iCite, a machine learning model that tracks the flow of knowledge into clinical medicine [ 27 , 28 ]. (Details on websites for searching NIH/Federal grants, patents, and bibliometric sources are provided in Appendix B.)

Review and analysis of health data should be performed where possible, including review of primary and secondary literature. For example, population health publications and databases can be used to describe changes in disease incidence and severity. In addition, healthcare utilization data may exist (e.g., from enterprise healthcare databases), providing information on health and medical spending. Analyzing federal, state, and health organization policies can help determine how the case may have influenced policy changes.

See Appendix B for a collection of useful data resources organized by research and practice phase as well as type of impact.

Formats of Finalized Case Study Materials

While the gold-standard for disseminating case study results is publishing in a peer-reviewed research journal, other formats should be considered for dissemination to wider audiences. For example, the NIH has posted several case studies on the Web in an effort to help communicate the value of biomedical research to the general public [ 29 ]. These web materials include brief summaries of the broader case study narrative as well as graphics (e.g., stylized timelines, figures, infographics), and detailed documentation and supplemental materials with further information.

There are several potential audiences for these case studies, including various research communities, research funders, health practitioners, domestic and international research policymakers, patient communities, and the general public. While it is encouraged to construct case studies for diverse audiences, findings can also be packaged in a variety of formats aimed at specific audiences. Each of these groups may have different needs, value different aspects of health research, and respond to different types of approaches for disseminating information.

Future Developments Toward Enhancing the Science of Translational Science

This protocol is intended to be an evolving document, which can be updated and refined as exemplary practices in the science of translational science emerge. This is one of several complementary efforts to enhance the identification of translational science success factors and provide a sustainable and useful framework for both the scholarly and practical study of translational science. Together with this protocol, we encourage the development of (1) appropriate publication outlets, (2) archiving strategies, and (3) coding schemes, to ensure high-quality work that is accessible for further research, including comparative studies.

• Publication outlets and review : We encourage the development of a special category of publication – the translational research case study – that could be included on an ongoing basis in appropriate journals. We believe a recognized publication mechanism would go a long way toward enhancing the consistency, quality, and accessibility of such reports. Independent peer review of such publications would help assure quality. Conducting case studies is time consuming; therefore, a recognized publication type would help overcome that barrier by providing professional and academic value in the form of creditable publications.
• Coding : Developing a coding scheme for translational research case studies would enhance their subsequent retrieval and meta-analyses. Each case study could be coded on a number of standard variables, including classification of the type of intervention, disease/disorder/public health research area, populations affected, key markers/milestones, key themes identified, outcomes achieved, and the translational stages covered by the case. No such classification system currently exists, and we should develop one inductively after accumulating a sufficient number of cases. A simple coding/classification scheme would be desirable to include as part of the case study report. Such a scheme would resemble the classifications used to store clinical trials in www.clinicaltrials.gov , such as the Medical Subject Headings (MeSH) coding scheme managed through the National Library of Medicine [ 30 ].
• Archiving : A central archiving repository for translational case studies would provide (1) a certifying mechanism for the quality of cases archived; (2) a motivational mechanism to encourage researchers to contribute to the literature of case studies; and (3) a database to support meta-analyses that could lead to broader generalizations about the factors that influence successful translational research. This repository would include rich meta-data on each study (e.g., coding data described above). Over time, such an archive would help to establish a body of comparable studies supporting research on translation and enable valuable cross-case analyses.

Conclusions

This protocol provides a systematic approach to study the multifaceted processes of translating research findings into practice. Researchers from diverse backgrounds can follow this protocol to analyze how scientific knowledge is translated into effective health interventions, identifying critical factors that enhance or impede progress along the way. This framework can be used to assess the long-range impacts of successful translational science efforts as well as examples of incomplete implementation. The combined analysis of successes and failures should inform funding agencies regarding designing grant mechanisms and investing in future translational research.

With this protocol, we hope to generate excitement for the broad conduct of translational science case studies. Dissemination of this protocol is a first step toward enabling a novel, coordinated approach for this application of the science of translational science. While rigorous, well-researched case studies are individually valuable, the most exciting use of this protocol lies in cross-case analyses, to identify leverage points and exemplary practices, as well as theories of change developed for further empirical testing. To realize this potential, several complementary efforts should be pursued, including the establishment of dedicated publication outlets, coding schemas, and a case study archive. All of this will take time to realize fully, but the long-term payoffs will be worth the effort when we can demonstrate that insights from these case studies can be used to enhance translational research and speed the delivery of life-saving medical and health interventions.

Acknowledgements

Thanks to Laura Hogan, Science Editor, at the Institute for Clinical and Translational Research at the University of Wisconsin-Madison for her thorough edit of the final manuscript draft. Thanks to Arthur E. Blank, Associate Professor Emeritus at Albert Einstein College of Medicine, for the idea and motivation to begin a translational science case studies group among CTSA evaluators. Several individuals contributed to the design of NIH’s case study methodology and conducted case studies to test, refine, and demonstrate the approach, including David Kosub, PhD (NIH), Elizabeth Baden, PhD (NICHD), Kristine Alexander, PhD (Cambia Health Solutions), Joel Baumgart, PhD (Emory University), and Peter Reczek, PhD (Standards Coordinating Body for Regenerative Medicine). Substantive review and comment on the manuscript was provided by Meredith D. Temple-O’Connor, PhD (NCATS), Kristianna Pettibone, PhD (NIEHS), Sue Hamman, PhD (NIDCR), Bob Zalutsky, PhD (NINDS), and Paul Scott, PhD (NINDS). In particular, we thank Marina Volkov, PhD (NIH) and David Bochner, PhD (NIDA) who contributed substantially to the case study design and provided critical comments on the draft manuscript.

Grant numbers: UL1 TR002548 (CMP), Clinical and Translational Science Collaborative (CTSC) of Cleveland, Case Western Reserve University. UL1TR002373 (LMS), Institute for Clinical and Translational Research (ICTR) at University of Wisconsin, Madison. UL1TR000457 (WMT) Clinical and Translational Science Center (CTSC) of Weill Cornell Medicine.

Supplementary material

Disclosures.

The authors have no conflicts of interest to declare.

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Title: a case study in analytic protocol analysis in acl2.

Abstract: When verifying computer systems we sometimes want to study their asymptotic behaviors, i.e., how they behave in the long run. In such cases, we need real analysis, the area of mathematics that deals with limits and the foundations of calculus. In a prior work, we used real analysis in ACL2s to study the asymptotic behavior of the RTO computation, commonly used in congestion control algorithms across the Internet. One key component in our RTO computation analysis was proving in ACL2s that for all alpha in [0, 1), the limit as n approaches infinity of alpha raised to n is zero. Whereas the most obvious proof strategy involves the logarithm, whose codomain includes irrationals, by default ACL2 only supports rationals, which forced us to take a non-standard approach. In this paper, we explore different approaches to proving the above result in ACL2(r) and ACL2s, from the perspective of a relatively new user to each. We also contextualize the theorem by showing how it allowed us to prove important asymptotic properties of the RTO computation. Finally, we discuss tradeoffs between the various proof strategies and directions for future research.

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Write an Error-free Research Protocol As Recommended by WHO: 21 Elements You Shouldn’t Miss!

Principal Investigator: Did you draft the research protocol?

Student: Not yet. I have too many questions about it. Why is it important to write a research protocol? Is it similar to research proposal? What should I include in it? How should I structure it? Is there a specific format?

Researchers at an early stage fall short in understanding the purpose and importance of some supplementary documents, let alone how to write them. Let’s better your understanding of writing an acceptance-worthy research protocol.

Table of Contents

What Is Research Protocol?

The research protocol is a document that describes the background, rationale, objective(s), design, methodology, statistical considerations and organization of a clinical trial. It is a document that outlines the clinical research study plan. Furthermore, the research protocol should be designed to provide a satisfactory answer to the research question. The protocol in effect is the cookbook for conducting your study

Why Is Research Protocol Important?

In clinical research, the research protocol is of paramount importance. It forms the basis of a clinical investigation. It ensures the safety of the clinical trial subjects and integrity of the data collected. Serving as a binding document, the research protocol states what you are—and you are not—allowed to study as part of the trial. Furthermore, it is also considered to be the most important document in your application with your Institution’s Review Board (IRB).

It is written with the contributions and inputs from a medical expert, a statistician, pharmacokinetics expert, the clinical research coordinator, and the project manager to ensure all aspects of the study are covered in the final document.

Is Research Protocol Same As Research Proposal?

Often misinterpreted, research protocol is not similar to research proposal. Here are some significant points of difference between a research protocol and a research proposal:

What Are the Elements/Sections of a Research Protocol?

According to Good Clinical Practice guidelines laid by WHO, a research protocol should include the following:

1. General Information

• Protocol title, protocol identifying number (if any), and date.
• Name and address of the funder.
• Name(s) and contact details of the investigator(s) responsible for conducting the research, the research site(s).
• Responsibilities of each investigator.
• Name(s) and address(es) of the clinical laboratory(ies), other medical and/or technical department(s) and/or institutions involved in the research.

2. Rationale & Background Information

• The rationale and background information provides specific reasons for conducting the research in light of pertinent knowledge about the research topic.
• It is a statement that includes the problem that is the basis of the project, the cause of the research problem, and its possible solutions.
• It should be supported with a brief description of the most relevant literatures published on the research topic.

3. Study Objectives

• The study objectives mentioned in the research proposal states what the investigators hope to accomplish. The research is planned based on this section.
• The research proposal objectives should be simple, clear, specific, and stated prior to conducting the research.
• It could be divided into primary and secondary objectives based on their relativity to the research problem and its solution.

4. Study Design

• The study design justifies the scientific integrity and credibility of the research study.
• The study design should include information on the type of study, the research population or the sampling frame, participation criteria (inclusion, exclusion, and withdrawal), and the expected duration of the study.

5. Methodology

• The methodology section is the most critical section of the research protocol.
• It should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made, laboratory investigations to be done, etc.
• The methodology should be standardized and clearly defined if multiple sites are engaged in a specified protocol.

6. Safety Considerations

• The safety of participants is a top-tier priority while conducting clinical research .
• Safety aspects of the research should be scrutinized and provided in the research protocol.

7. Follow-up

• The research protocol clearly indicate of what follow up will be provided to the participating subjects.
• It must also include the duration of the follow-up.

8. Data Management and Statistical Analysis

• The research protocol should include information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification.
• It should clearly outline the statistical methods proposed to be used for the analysis of data.
• For qualitative approaches, specify in detail how the data will be analysed.

9. Quality Assurance

• The research protocol should clearly describe the quality control and quality assurance system.
• These include GCP, follow up by clinical monitors, DSMB, data management, etc.

10. Expected Outcomes of the Study

• This section indicates how the study will contribute to the advancement of current knowledge, how the results will be utilized beyond publications.
• It must mention how the study will affect health care, health systems, or health policies.

11. Dissemination of Results and Publication Policy

• The research protocol should specify not only how the results will be disseminated in the scientific media, but also to the community and/or the participants, the policy makers, etc.
• The publication policy should be clearly discussed as to who will be mentioned as contributors, who will be acknowledged, etc.

12. Duration of the Project

• The protocol should clearly mention the time likely to be taken for completion of each phase of the project.
• Furthermore a detailed timeline for each activity to be undertaken should also be provided.

13. Anticipated Problems

• The investigators may face some difficulties while conducting the clinical research. This section must include all anticipated problems in successfully completing their projects.
• Furthermore, it should also provide possible solutions to deal with these difficulties.

14. Project Management

• This section includes detailed specifications of the role and responsibility of each investigator of the team.
• Everyone involved in the research project must be mentioned here along with the specific duties they have performed in completing the research.
• The research protocol should also describe the ethical considerations relating to the study.
• It should not only be limited to providing ethics approval, but also the issues that are likely to raise ethical concerns.
• Additionally, the ethics section must also describe how the investigator(s) plan to obtain informed consent from the research participants.
• This section should include a detailed commodity-wise and service-wise breakdown of the requested funds.
• It should also include justification of utilization of each listed item.

17. Supplementary Support for the Project

• This section should include information about the received funding and other anticipated funding for the specific project.

18. Collaboration With Other Researchers or Institutions

• Every researcher or institute that has been a part of the research project must be mentioned in detail in this section of the research protocol.

19. Curriculum Vitae of All Investigators

• The CVs of the principal investigator along with all the co-investigators should be attached with the research protocol.
• Ideally, each CV should be limited to one page only, unless a full-length CV is requested.

20. Other Research Activities of Investigators

• A list of all current research projects being conducted by all investigators must be listed here.

21. References

• All relevant references should be mentioned and cited accurately in this section to avoid plagiarism.

How Do You Write a Research Protocol? (Research Protocol Example)

Main Investigator    

Number of Involved Centers (for multi-centric studies)

Indicate the reference center

Title of the Study

Protocol ID (acronym)

Keywords (up to 7 specific keywords)

Study Design

Mono-centric/multi-centric

Perspective/retrospective

Controlled/uncontrolled

Open-label/single-blinded or double-blinded

Randomized/non-randomized

n parallel branches/n overlapped branches

Experimental/observational

Endpoints (main primary and secondary endpoints to be listed)

Expected Results                                                

Analyzed Criteria

Main variables/endpoints of the primary analysis

Main variables/endpoints of the secondary analysis

Safety variables

Health Economy (if applicable)

Visits and Examinations

Therapeutic plan and goals

Visits/controls schedule (also with graphics)

Comparison to treatment products (if applicable)

Dose and dosage for the study duration (if applicable)

Formulation and power of the studied drugs (if applicable)

Method of administration of the studied drugs (if applicable)

Informed Consent

Study Population

Short description of the main inclusion, exclusion, and withdrawal criteria

Sample Size

Estimated Duration of the Study

Safety Advisory

Classification Needed

Requested Funds

Additional Features (based on study objectives)

Click Here to Download the Research Protocol Example/Template

Be prepared to conduct your clinical research by writing a detailed research protocol. It is as easy as mentioned in this article. Follow the aforementioned path and write an impactful research protocol. All the best!

Clear as template! Please, I need your help to shape me an authentic PROTOCOL RESEARCH on this theme: Using the competency-based approach to foster EFL post beginner learners’ writing ability: the case of Benin context. I’m about to start studies for a master degree. Please help! Thanks for your collaboration. God bless.

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The Case Study Protocol

A case study protocol has only one thing in common with a survey question­naire: Both are directed at a single data point—either a single case (even if the case is part of a larger, multiple-case study) or a single respondent.

Beyond this similarity are major differences. The protocol is more than a questionnaire or instrument. First, the protocol contains the instrument but also contains the procedures and general rales to be followed in using the pro­tocol. Second, the protocol is directed at an entirely different party than that of a survey questionnaire, explained below. Third, having a case study protocol is desirable under all circumstances, but it is essential if you are doing a mul­tiple-case study.

The protocol is a major way of increasing the reliability of case study research and is intended to guide the investigator in carrying out the data col­lection from a single case (again, even if the single case is one of several in a multiple-case study). Figure 3.2 gives a table of contents from an illustrative protocol, which was used in a study of innovative law enforcement practices supported by federal funds. The practices had been defined earlier through a careful screening process (see later discussion in this chapter for more detail on “screening case study nominations”). Furthermore, because data were to be collected from 18 such cases as part of a multiple-case study, the information about any given case could not be collected in great depth, and thus the number of the case study questions was minimal.

As a general matter, a case study protocol should have the following sections:

• an overview of the case study project (project objectives and auspices, case study issues, and relevant readings about the topic being investigated),
• field procedures (presentation of credentials, access to the case study “sites,” language pertaining to the protection of human subjects, sources of data, and procedural reminders),
• case study questions (the specific questions that the case study investigator must keep in mind in collecting data, “table shells” for specific arrays of data, and the potential sources of information for answering each question—see Figure 3.3 for an example), and
• a guide for the case study report (outline, format for the data, use and presenta­tion of other documentation, and bibliographical information).

A quick glance at these topics will indicate why the protocol is so important. First, it keeps you targeted on the topic of the case study. Second, preparing the protocol forces you to anticipate several problems, including the way that the case study reports are to be completed. This means, for instance, that you will have to identify the audience for your case study report even before you have conducted your case study. Such forethought will help to avoid mismatches in the long run.

The table of contents of the illustrative protocol in Figure 3.2 reveals another important feature of the case study report: In this instance, the desired report starts by calling for a description of the innovative practice being studied (see item Cl in Figure 3.2)—and only later covers the agency context and history pertaining to the practice (see item C4). This choice reflects the fact that most investigators write too extensively on history and background conditions. While these are important, the description of the subject of the study—the innovative practice—needs more attention.

Each section of the protocol is discussed next.

1. Overview of the Case Study Project

The overview should cover the background information about the project, the substantive issues being investigated, and the relevant readings about the issues.

As for background information, every project has its own context and perspective. Some projects, for instance, are funded by government agencies having a general mission and clientele that need to be remembered in con­ducting the research. Other projects have broader theoretical concerns or are offshoots, of earlier research studies. Whatever the situation, this type of back­ground information, in summary form, belongs in the overview section.

A procedural element of this background section is a statement about the project which you can present to anyone who may want to know about the pro­ject, its purpose, and the people involved in conducting and sponsoring the project. This statement can even be accompanied by a letter of introduction, to be sent to all major interviewees and organizations that may be the subject of study. (See Figure 3.4 for an illustrative letter.) The bulk of the overview, how­ever, should be devoted to the substantive issues being investigated. This may include the rationale for selecting the case(s), the propositions or hypotheses being examined, and the broader theoretical or policy relevance of the inquiry. For all of these topics, relevant readings should be cited, and the essential read­ing materials should be made available to everyone on the case study team.

A good overview will communicate to the informed reader (that is, some­one familiar with the general topic of inquiry) the case study’s purpose and set­ting. Some of the materials (such as a summary describing the project) may be needed for other purposes anyway, so that writing the overview should be seen as a doubly worthwhile activity. In the same vein, a well-conceived overview even may later form the basis for the background and introduction to the final case study report.

2. Field Procedures

Chapter 1 has previously defined case studies as studies of events within their real-life context. This has important implications for defining and design­ing the case study, which have been discussed in Chapters 1 and 2.

For data collection, however, this characteristic of case studies also raises an important issue, for which properly designed field procedures are essential. You will be collecting data from people and institutions in their everyday situations, not within the controlled confines of a laboratory, the sanctity of a library, or the structured limitations of a survey questionnaire. In a case study, you must there­fore learn to integrate real-world events with the needs of the data collection plan. In this sense, you do not have the control over the data collection environment as others might have in using the other research methods discussed in Chapter 1.

Note that in a laboratory experiment, human “subjects” are solicited to enter into the laboratory—an environment controlled nearly entirely by the research investigator. The subject, within ethical and physical constraints, must follow the investigator’s instructions, which carefully prescribe the desired behavior. Similarly, the human “respondent” to a survey questionnaire cannot deviate from the agenda set by the questions. Therefore, the respondent’s behavior also is con­strained by the ground rules of the investigator. Naturally, the subject or respon­dent who does not wish to follow the prescribed behaviors may freely drop out of the experiment or survey. Finally, in the historical archive, pertinent documents may not always be available, but the investigator can inspect what exists at his or her own pace and at a time convenient to her or his schedule. In all three situa­tions, the research investigator closely controls the formal data collection activity.

Doing case studies involves an entirely different situation. For interviewing key persons, you must cater to the interviewee’s schedule and availability, not your own. The nature of the interview is much more open-ended, and an interviewee may not necessarily cooperate fully in sticking to your line of questions. Similarly, in making observations of real-life activities, you are intruding into the world of the subject being studied rather than the reverse; under these conditions, you are the one who may have to make special arrangements, to be able to act as an observer (or even as a participant- observer). As a result, your behavior—and not that of the subject or respon­dent—is the one likely to be constrained.

This contrasting process of doing data collection leads to the need to have explicit and well-planned field procedures encompassing guidelines for “cop­ing” behaviors. Imagine, for instance, sending a youngster to camp; because you do not know what to expect, the best preparation is to have the resources to be prepared. Case study field procedures should be the same way.

With the preceding orientation in mind, the field procedures of the protocol need to emphasize the major tasks in collecting data, including

• gaining access to key organizations or interviewees;
• having sufficient resources while in the field—including a personal computer, writing instruments, paper, paper clips, and a preestablished, quiet place to write notes privately;
• developing a procedure for calling for assistance and guidance, if needed, from other case study investigators or colleagues;
• making a clear schedule of the data collection activities that are expected to be completed within specified periods of time; and
• providing for unanticipated events, including changes in the availability of interview­ees as well as changes in the mood and motivation of the case study investigator.

These are the types of topics that can be included in the field procedures sec­tion of the protocol. Depending upon the type of study being done, the specific procedures will vary.

The more operational these procedures are, the better. To take but one minor issue as an example, case study data collection frequently results in the accu­mulation of numerous documents at the field site. The burden of carrying such bulky documents can be reduced by two procedures. First, the case study team may have had the foresight to bring large, prelabeled envelopes, to mail the documents back to the office rather than carry them. Second, field time may have been set aside for perusing the documents and then going to a local copier facility and copying only the few relevant pages of each document—and then returning the original documents to the informants at the field site. These and other operational details can enhance the overall quality and efficiency of case study data collection.

A final part of this portion of the protocol should carefully describe the procedures for protecting human subjects. First, the protocol should repeat the rationale for the IRB-approved field procedures. Then, the protocol should include the “scripted” words or instructions for the team to use in obtaining informed consent or otherwise informing case study interviewees and other participants of the risks and conditions associated with the research.

3. Case Study Questions

The heart of the protocol is a set of substantive questions reflecting your actual line of inquiry. Some people may consider this part of the protocol to be the case study “instrument.” However, two characteristics distinguish case study questions from those in a survey instrument. (Refer back to Figure 3.3 for an illustrative question from a study of a school program; the complete protocol included dozens of such questions.)

General orientation of questions. First, the questions are posed to you, the investigator, not to an interviewee. In this sense, the protocol is directed at an entirely different party than a survey instrument. The protocol’s questions, in essence, are your reminders regarding the information that needs to be col­lected, and why. In some instances, the specific questions also may serve as prompts in asking questions during a case study interview. However, the main purpose of the protocol’s questions is to keep the investigator on track as data collection proceeds.

Each question should be accompanied by a list of likely sources of evidence. Such sources may include the names of individual interviewees, documents, or observations. This crosswalk between the questions of interest and the likely sources of evidence is extremely helpful in collecting case study data. Before arriving on the case study scene, for instance, a case study investigator can quickly review the major questions that the data collection should cover.

(Again, these questions form the structure of the inquiry and are not intended as the literal questions to be asked of any given interviewee.)

Levels of questions. Second, the questions in the case study protocol should distinguish clearly among different types or levels of questions. The poten­tially relevant questions can, remarkably, occur at any of five levels:

Level 1: questions asked of specific interviewees;

Level 2: questions asked of the individual case (these are the questions in the case study protocol to be answered by the investigator during a single case, even when the single case is part of a larger, multiple-case study);

Level 3: questions asked of the pattern of findings across multiple cases;

Level 4: questions asked of an entire study—for example, calling on information beyond the case study evidence and including other literature or published data that may have been reviewed; and

Level 5: normative questions about policy recommendations and conclusions, going beyond the narrow scope of the study.

Of these five levels, you should concentrate heavily on Level 2 for the case study protocol.

The difference between Level 1 and Level 2 questions is highly significant. The two types of questions are most commonly confused because investigators think that their questions of inquiry (Level 2) are synonymous with the spe­cific questions they will ask in the field (Level 1). To disentangle these two levels in your own mind, think again about a detective, especially a wily one. The detective has in mind what the course of events in a crime might have been (Level 2), but the actual questions posed to any witness or suspect (Level 1) do not necessarily betray the detective’s thinking. The verbal line of inquiry is different from the mental line of inquiry, and this is the difference between Level 1 and Level 2 questions. For the case study protocol, explicitly articu­lating the Level 2 questions is therefore of much greater importance than any attempt to identify the Level 1 questions.

In the field, keeping in mind the Level 2 questions while simultaneously articulating Level 1 questions in conversing with an interviewee is not easy. In a like manner, you can lose sight of your Level 2 questions when examin­ing a detailed document that will become part of the case study evidence (the common revelation occurs when you ask yourself, “Why am I reading this document?”). To overcome these problems, successful participation in the earlier seminar training helps. Remember that being a “senior” investigator means maintaining a working knowledge of the entire case study inquiry. The (Level 2) questions in the case study protocol embody this inquiry.

The other levels also should be understood clearly. A cross-case question, for instance (Level 3), may be whether the larger school districts among your cases are more responsive than smaller school districts or whether complex bureaucratic structures make the larger districts more cumbersome and less responsive. However, this Level 3 question should not be part of the protocol for collecting data from the single case, because the single case only can address the responsiveness of a single school district. The Level 3 question cannot be addressed until the data from all the single cases (in a multiple-case study) are examined. Thus, only the multiple-case analysis can cover Level 3 questions. Similarly, the questions at Levels 4 and 5 also go well beyond any individual case study, and you should note this limitation if you include such questions in the case study protocol. Remember: The protocol is for the data collection from a single case (even when part of a multiple-case study) and is not intended to serve the entire project.

Undesired confusion between unit of data collection and unit of analysis. Related to the distinction between Level 1 and Level 2 questions, a more sub­tle and serious problem can arise in articulating the questions in the case study protocol. The questions should cater to the unit of analysis of the case study, which may be at a different level from the unit of data collection of the case study. Confusion will occur if, under these circumstances, the data collection process leads to an (undesirable) distortion of the unit of analysis.

The common confusion begins because the data collection sources may be individual people (e.g., interviews with individuals), whereas the unit of analy­sis of your case study may be a collective (e.g., the organization to which the individual belongs)—a frequent design when the case study is about an orga­nization, community, or social group. Even though your data collection may have to rely heavily on information from individual interviewees, your con­clusions cannot be based entirely on interviews as a source of information (you would then have collected information about individuals’ reports about the organization, not necessarily about organizational events as they actually had occurred). In this example, the protocol questions therefore need to be about the organization, not the individual.

However, the reverse situation also can be true. Your case study may be about an individual, but the sources of information can include archival records (e.g., personnel files or student records) from an organization. In this situation, you also would want to avoid basing your conclusions about the individual from the organizational sources of information only. In this example, the protocol ques­tions therefore need to be about the individual, not the organization.

Figure 3.5 illustrates these two situations, where the unit of analysis for the case study is different from the unit of data collection.

Other data collection devices. The protocol questions also can include empty “table shells” (for more detail, see Miles & Huberman, 1994). These are the outlines of a table, defining precisely the “rows” and “columns” of a data array—but in the absence of having the actual data. In this sense, the table shell indicates the data to be collected, and your job is to collect the data called forth by the table. Such table shells help in several ways. First, the table shells force you to identify exactly what data are being sought. Second, they ensure that parallel information will be collected at different sites, where a multiple- case design is being used. Finally, the table shells aid in understanding what will be done with the data once they have been collected.

4. Guide for the Case Study Report

This element is generally missing in most case study plans. Investigators neglect to think about the outline, format, or audience for the case study report until after the data have been collected. Yet, some planning at this preparatory stage—admittedly out of sequence in the typical conduct of most research— means that a tentative outline can (and should) appear in the case study protocol. (Such planning accounts for the arrow between “prepare” and “share” in the figure at the outset of this chapter.)

Again, one reason for the traditional, linear sequence is related to practices with other research methods. One does not worry about the report from an exper­iment until after the experiment has been completed, because the format of the report and its likely audience already have been dictated by the conventional for­mats of academic journals. Most reports of experiments follow a similar outline: the posing of the research questions and hypotheses; a description of the research design, apparatus, and data collection procedures; the presentation of the data collected; the analysis of the data; and a discussion of findings and conclusions.

Unfortunately, case study reports do not have such a uniformly acceptable outline. Nor, in many instances, do case study reports end up in journals (Feagin et al., 1991, pp. 269-273). For this reason, each investigator must be concerned, throughout the conduct of a case study, with the design of the final case study report. The problem is not easy to deal with.

In addition, the protocol also can indicate the extent of documentation for the case study report. Properly done, the data collection is likely to lead to large amounts of documentary evidence, in the form of published reports, publica­tions, memoranda, and other documents collected about the case. What is to be done with this documentation, for later presentation? In most studies, the docu­ments are filed away and seldom retrieved. Yet, this documentation is an impor­tant part of the “database” for a case study (see Chapter 4) and should not be ignored until after the case study has been completed. One possibility is to have the case study report include an annotated bibliography in which each of the available documents is itemized. The annotations would help a reader (or the investigator, at some later date) to know which documents might be relevant for further inquiry.

In summary, to the extent possible, the basic outline of the case study report should be part of the protocol. This will facilitate the collection of relevant data, in the appropriate format, and will reduce the possibility that a return visit to the case study site will be necessary. At the same time, the existence of such an outline should not imply rigid adherence to a predesigned protocol. In fact, case study plans can change as a result of the initial data collection, and you are encouraged to consider these flexibilities—if used properly and with­out bias—to be an advantage of the case study method.

EXERCISE 3.4 Developing a Case Study Protocol

Select some phenomenon in need of explanation from the everyday life of your university or school (past or present). Illustrative topics might be, for example, why the university or school changed some policy or how it makes decisions about its curriculum requirements. For these illustrative topics (or some topics of your own choosing), design a case study protocol to collect the information needed to make an adequate explanation. What would be your main research questions or propositions? What specific sources of data would you seek (e.g., persons to be interviewed, documents to be sought, and field observations to be made)? Would your protocol be sufficient in guiding you through the entire process of doing your case study?

Source: Yin K Robert (2008), Case Study Research Designs and Methods , SAGE Publications, Inc; 4th edition.

13 Aug 2021

23 Oct 2019

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THE CASE STUDY PROTOCOL

Research methodology.

The case study protocol defines the procedures and general rules to be followed using the protocol which is different from a survey questionnaire” (Yin, 2009, p. 79). The case study protocol and a survey questionnaire are both directed at a single data point, whether it’s a single case or a single respondent (Yin, 2009). A case study protocol is always needed when

performing a multiple-case study (Yin, 2009). The protocol is a major way of increasing the

reliability of case study research and is intended to guide the researcher in carrying out data

collection from a single case (Yin, 2009). A case study protocol should have at least the following sections (Yin, 2009, p. 81):

1. Overview of the case study project (project objectives and auspices, case study issues, and relevant readings about the topic being investigated).

2. Field procedures (presentation of credentials, access to the case study “sites”, language pertaining to the protection of human subjects, sources of data, and procedural reminders).

3. Field procedures (the specific questions that the case study must keep in mind in collecting data, “table shells” for specific arrays of data, and the potential sources of information for answering each question …).

4. Investigator guide for the case study report (outline, format of the data, use and presentation of other documentation, and bibliographical information).

The importance of the protocol helps the researcher to remain focused on the topic and problem areas. This intuitive knowledge of the context and perspective will guide the researcher in the search for supporting information. By writing an overview of the case study, the researcher allows potential knowledge seeker to capitalize on the products of the case study and understand beforehand, the intent and depth of the case study research. There are also potential guidelines for field procedure. A researcher’s “field procedure of the protocol need to emphasize the major tasks in collecting data, including gaining access to key organizations or interviewees” (Yin, 2009, p. 85):

1. Having sufficient resources while in the field – including a personal computer, writing instruments, paper, paper clips, and a pre-established, quiet place to write notes privately.

2. Developing a procedure for calling for assistance and guidance, if needed, from other case study investigators or colleagues.

3. Making a clear schedule of the data collection activates that are expected to be completed within specified periods of time.

4. Providing for unanticipated events, including changes in the availability of interviewees as well as changes in the mood and motivation of the case study investigator.

“The heart of the protocol is a set of substantive questions reflecting your actual line of inquiry” (Yin, 2009, p. 86). Each question should be “posed to you, the investigator, not to an

interviewee” and linked to a source of evidence (Yin, 2009, p. 86). Each question of this protocol should reflect a specific type/level potentially categorized by Yin’s five levels of questions below (Yin, 2009, p. 86):

1. Level 1: question asked of specific interviewees.

2. Level 2: questions asked of the individual case (these are the questions in the case study protocol to be answered by the investigator during a single case, even when the single case is part of a larger, multiple-case study).

3. Level 3: questions asked of the pattern of findings across multiple cases.

4. Level 4: questions asked of the entire study – for example, calling the information beyond the case study evidence and including other literature or published data that may have been reviewed.

5. Level 5: normative questions about policy recommendations and conclusions, going beyond the narrow scope of study.

“The questions should cater to the unit of analysis of the case study, which may be at a different level from the unit of data collection of the case study” (Yin, 2009, p. 88). “The common

confusion begins because the data collection sources may be individual people (e.g., interviews with individuals), whereas the unit of analysis of your case study may be a collective (e.g., the organization to which the individual belongs) - a frequent design when the case is about the organization, community, or social group” (Yin, 2009, p. 88). Table 6 below illustrates design verses data collection using different units of analysis:

Individual behavior Individual attitudes Individual perceptions

Individual employee records Interview with individual’s supervisor; other employees

How organization works

Why organization works Personnel policiesOrganization outcomes

Abo ut a n indi vidua l Abo ut a n or ga ni za tion De sig n

From an individual From an organization

Data Collection Source

Table 6: Design verses Data Collected

Table 6 above, Design verses Data Collection, helps the researcher to identify exactly what data is desired and ensures parallel information is collected from different sites as during a multiple case study (Yin, 2009, p. 89). The researcher should include an outline in the protocol to guide

in the collection, presentation, and formatting of data (Yin, 2009). This rigor allows other researchers to follow the case (Yin, 2009). The researcher may choose a pilot case to discover unforeseen issues or challenges (Yin, 2009). The protocol helps align the researcher’s data collection efforts.

The case study protocol defines the procedures and general rules to be followed using the protocol (Yin, 2009). Yin (2009) reminds the researcher that the protocol is a major way of increasing the reliability of case study research and is intended to guide the researcher in carrying out data collection from a single case. The case study protocol should contain at minimum the following sections (Yin, 2009): (1) Overview of the case study project; (2) Field procedures (credentials); (3) Field procedures (questions); and (4) a form of investigator guide for the case study report. The importance of the protocol helps the researcher to remain focused on the topic and problem areas. Design verses Data Collection helps the researcher to identify exactly what data is desired and ensures parallel information is collected from different (Yin, 2009). The case study protocol is used in the collection of case study evidence as described in the next section.

• PROJECT MANAGEMENT SYSTEMS (PMS)
• PMS: PMBOK PERSPECTIVE
• CYBERNETICS: PRELUDE TO THE VSM
• VIABLE SYSTEM MODEL (VSM)
• ORIGINS OF THE VSM
• SYSTEM FOUR
• CASE STUDY RESEARCH
• COMPONENTS OF RESEARCH DESIGN
• CASE STUDY DESIGNS
• THE CASE STUDY PROTOCOL (You are here)
• COLLECTING CASE STUDY EVIDENCE
• FRAMEWORK DEVELOPMENT
• DATA COLLECTION STRATEGIES
• ROLE OF THE RESEARCHER
• PROJECT Q: A CASE STUDY

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• Study Protocol
• Open access
• Published: 26 March 2024

The effect of a midwifery continuity of care program on clinical competence of midwifery students and delivery outcomes: a mixed-methods protocol

• Fatemeh Razavinia   ORCID: orcid.org/0000-0002-6827-509X 1 , 2 ,
• Parvin Abedi   ORCID: orcid.org/0000-0002-6980-0693 3 ,
• Mina Iravani   ORCID: orcid.org/0000-0002-8854-1738 4 ,
• Eesa Mohammadi   ORCID: orcid.org/0000-0001-6169-9829 5 ,
• Bahman Cheraghian   ORCID: orcid.org/0000-0001-5446-6998 6 ,
• Shayesteh Jahanfar   ORCID: orcid.org/0000-0001-6149-1067 7 &
• Mahin Najafian   ORCID: orcid.org/0000-0002-6649-3931 8  

BMC Medical Education volume  24 , Article number:  338 ( 2024 ) Cite this article

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Metrics details

The midwifery continuity of care model is one of the care models that have not been evaluated well in some countries including Iran. We aimed to assess the effect of a program based on this model on the clinical competence of midwifery students and delivery outcomes in Ahvaz, Iran.

This sequential embedded mixed-methods study will include a quantitative and a qualitative phase. In the first stage, based on the Iranian midwifery curriculum and review of seminal midwifery texts, a questionnaire will be developed to assess midwifery students’ clinical competence. Then, in the second stage, the quantitative phase (randomized clinical trial) will be conducted to see the effect of continuity of care provided by students on maternal and neonatal outcomes. In the third stage, a qualitative study (conventional content analysis) will be carried out to investigate the students’ and mothers’ perception of continuity of care. Finally, the results of the quantitative and qualitative phases will be integrated.

According to the nature of the study, the findings of this research can be effectively used in providing conventional midwifery services in public centers and in midwifery education.

Trial registration

This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1401.460). Also, the study protocol was registered in the Iranian Registry for Randomized Controlled Trials (IRCT20221227056938N1).

Peer Review reports

Providing quality services to pregnant women has been recommended to all countries to achieve the Millennium Development Goals (MDGs) (Goals 3, 4 and 5) [ 1 ]. There are different care methods to maintain maternal and neonatal health during pregnancy and postpartum [ 1 ]. One of these care models is continuity of care that can be provided by a midwife or an obstetrician.

Midwifery continuity of care is a relationship-based care provided by a midwife who can be supported by one to three more midwives. They provide planned care for a woman during pregnancy, labor, birth, and the early postpartum period up to 6 weeks after delivery [ 2 ].

Continuity of midwifery care has become a global effort to enable women to have access to high-quality maternity care and delivery services [ 3 ]. As a result, many service providers today are transitioning to a continuous care model [ 4 ], and they have considered continuous care to be necessary for realizing women's rights [ 5 ]. Also, continuous midwifery care is known as the gold standard in maternity care to achieve excellent results for women [ 5 , 6 ]. In order to strengthen midwifery services to achieve global health goals in 2015, the World Health Organization (WHO) proposed a midwife-led continuous care model [ 7 ].

Countries use different midwifery care models. In Iran, for example, primary health services that are specific to pregnant mothers are provided in public health centers by midwives working in the network system and in compliance with the level of services and the referral system [ 8 ].

In general, midwifery continuous care not only has an important impact on a wide range of health and clinical outcomes for mothers and neonates but also brings about economic consequences for the health system [ 2 , 9 ]. This care model is useful for healthcare professionals as well [ 10 ], and it has improved the job satisfaction of midwives [ 11 ]. The midwife is the main guide in planning, organizing and providing care to a woman from the beginning of pregnancy to the postpartum period [ 12 ]. In 2011, in order to increase job motivation and satisfaction, promote retention of the midwifery workforce [ 13 ], and alleviate the shortage of workforce at the international level [ 14 ], the Nursing and Midwifery Advisory Center recommended using midwifery students (at the bedside and to perform midwifery work) to overcome this problem.

Providing high quality care requires enhancing the clinical competence of the professionals [ 4 ]. There is a close relationship between the concept of patient care quality and clinical competence. Therefore, clinical competence is of unique importance in midwifery practice [ 15 ]. As a result, in order to achieve quality patient care, midwifery professionals need to train students to become workforce with clinical competence in order to provide quality care in the health system. WHO defined clinical competence as a level of performance that demonstrates the effective application of knowledge, skills, and judgment [ 16 ].

A previous study showed that clinical competence of midwives plays an important role in managing the process of providing care, achieving care goals, and improving the quality of midwifery services [ 17 ]. In other words, the graduates of this field must have an acceptable level of clinical and professional skills in performing midwifery duties so that the health of mothers, children, and ultimately the community can be improved.

In Iran, prenatal care and the care during labor, delivery and postpartum are not continuous, and a new health provider may take the responsibility of care at any stage. This fragmented care may negatively affect the pregnancy outcomes and increase the rate of cesarean section [ 18 ]. Furthermore, the results of some studies in Iran indicate that the clinical competence obtained by midwifery students is far from optimal and that they do not acquire the necessary skills and abilities at the end of their studies [ 19 ]. Farrokhi et al. showed that the performance quality of 70% of midwives is average, and only 18.5% of them have good quality performance [ 20 ]. Several factors play a role in acquiring, maintaining and improving clinical competence [ 21 ]. There are a number of solutions that can increase the clinical competence of midwifery students, and one is the use of different care models such as the continuity of care model. The continuity of care model allows students to develop their midwifery knowledge, skills, and values individually [ 22 ]. Despite the strong foundation of midwifery in Iran, midwifery care models have not yet been tested. Some studies have reported that the quality of services provided during pregnancy, delivery and after delivery in Iran is poor to moderate. Also, these studies emphasize the necessity of a paradigm shift for better quality care and greater satisfaction of mothers, and they consider lack of continuity of care as the reason for the increase in unnecessary cesarean sections [ 23 , 24 , 25 ]. Moreover, the lack of qualified and experienced workforce has led to low quality health services, including midwifery care, and an increase in the economic burden of health. In Iran, no study has yet been conducted to investigate the effect of the midwifery continuity of care model on the students’ clinical competence and pregnancy outcomes. Given the importance of this topic, using a mixed-methods study design, we aimed to assess the effect of a midwifery continuity of care program on the clinical competence of midwifery students and pregnancy outcomes in Ahvaz, Iran.

Specific objectives

To determine the effect of midwifery continuity of care program on the clinical competence of midwifery students.

To determine the effect of a midwifery continuity of care program provided by midwifery students on pregnancy outcomes.

To explain the perception of midwifery students and mothers about the use of the midwifery continuity of care program provided by midwifery students.

Methods/design

Study design.

This sequential embedded mixed-methods study will include a quantitative phase and a qualitative one. A mixed (embedded) experimental design involves the collection and analysis of quantitative and qualitative data by the researcher and the integration of the information into an experimental study or intervention trial. This design adds qualitative data to an experiment or intervention to integrate the personal experience of research participants. Therefore, the qualitative data are converted into a secondary source of data embedded before and after the test. Qualitative data is added to the experiment in differrent ways, including: before the experiment, during the experiment, or after the experiment [ 26 , 27 ]. Embedded mixed-methods studies that are qualitative followed by quantitative are used to understand the rationale for the results and receive feedback from participants (to confirm and support the findings of the quantitative studies) [ 27 ]. In the first stage of this study, a questionnaire for assessing midwifery students’ clinical competence will be created based on the midwifery curriculum of Iran and a review of seminal texts of midwifery. Then, the effect of continuity of care provided by midwifery students on maternal and neonatal outcomes will be assessed in a randomized clinical trial. In the third stage, a qualitative study will be carried out to investigate the perception of students and mothers. Finally, the results of the quantitative and qualitative phases will be integrated (Fig.  1 ).

Sequential and embedded mixed-methods design

First stage: questionnaire development

This questionnaire will be developed based on midwifery curriculum and a comprehensive and systematic search (with no time limit) in English and Persian databases (Web of Science, Embase, Scopus, ProQuest, Google scholar, Magiran, SID).

Tool design

There are four steps in tool development:

Choosing a conceptual model to show aspects of clinical competence in the measurement process

Explaining the purpose of the tool

Designing the route map

Developing the tool (use of methods, classification of objects, rules and procedures for scoring tools) [ 28 ].

Answer to the objects

A 1 to 4-point Likert scale will be used for scoring [ 29 ].

Content validity

To ensure the selection of the most important and correct content (necessity of the case), the content validity will be assessed. Also, to ensure that the instrument items are designed in the best way to measure the content, the content validity index will be calculated [ 30 ].

Reliability

Reliability will be evaluated using internal consistency (Cronbach's alpha coefficient ≥ 0.7) and stability (test-re-test ≥ 0.74) by piloting the questionnaire on 20 midwifery students [ 31 ].

Second stage: quantitative phase

A randomized controlled clinical trial will be conducted in this phase of research to examine the effect of the continuous care program of midwifery students on their clinical competence and pregnancy outcomes.

Sample size

According to the study objective and previous study results [ 32 ] with α = 0.01, β = 0.1, p 1  = 0.51 and p 2  = 0.021, the sample size will be n  = 23. Considering a 20% dropout rate, the final sample size will be 58 women (29 women in each group).

Data collection

This phase of the randomized clinical trial will be conducted with the participation of 58 undergraduate midwifery students at their 7th and 8th semesters. The students will be divided randomly to intervention (continuous care) and control (routine care) groups providing care to 58 pregnant women in six health centers and two hospitals (Sina and Razi) in Ahvaz city, southwest of Iran.

The study will begin after receiving the approval of the Ethics Committee of Ahvaz University of Medical Sciences and registering the study in the Iranian Registry for Randomized Clinical Trials. Inclusion criteria will be willingness to participate in the study.

Randomization

To implement the intervention, the students will be divided into two intervention (providing continuous care for pregnant women) and control (providing standard care for pregnant women) groups. Allocating students will be done using permuted block randomization technique with a block size of four and an allocation ratio of 1:1. Five blocks of 4 pieces and 3 blocks of 3 pieces will be extracted randomly using WIN PEPI software. In each block of 4, 2 students will be in control and 2 will be in intervention group. Also, in each block of 3 students, 1 student will be in control and 2 will be in intervention group, and the arrangement of each person is random. To prevent contamination, first the control group will provide routine care, and then the intervention group will conduct continuity of care for pregnant women. Mothers are randomly selected based on the hospital where they will give birth. As a result, Razi Hospital will be the control group and Sina Hospital will be the intervention group.

Intervention

Women who meet the inclusion criteria will be recruited in the study using a non-probability convenience sampling method. Women in the intervention group will be included in the study after their first pregnancy visit (6–10 weeks of gestation) and will receive continuous care by midwifery students. Women in the control group will receive the usual and routine care, and will be included in the study at the time of delivery. They will have a gestational age of more than 37 weeks based on the inclusion criteria of the study. Their delivery will be performed by midwifery students who will follow them up until six weeks after delivery.

At first, the necessary training will be given by the lead researcher (FR) to the students in orientation sessions held for both groups separately. In the intervention group, each midwifery student as the main midwife will be responsible for taking care of two or three pregnant women and will be the back-up midwife for two other pregnant women (under the supervision of other students). The lead researcher will create a group in WhatsApp with the participation of students in the intervention group, and they can communicate with each other and the researcher. Also, the midwifery students will be directly and indirectly under the supervision of a qualified person (lead researcher). Another WhatsApp group will be created for the women of the intervention and control groups (to facilitate communication between the researcher and the women). Two midwifery students will be introduced to each pregnant woman in the intervention group (as a main midwife and a backup midwife). If the main midwife is not available, the woman will be in contact with the backup midwife. The backup student will meet the woman at least once and will be introduced to her.

Instruments

All students and pregnant women participating in this study will complete a demographic questionnaire. A checklist will be provided for collecting data during prenatal care, labor, and delivery.

Also, the midwifery students will complete the clinical competency questionnaire at the beginning and end of the study.

Care will be provided and recorded by the main student according to the pregnancy care protocol. Also, danger signs will be taught to the students according to the national protocol, and emergencies will be handled by the midwifery student under the supervision of the lead researcher. Admission to hospital will be arranged by the student, and all information will be recorded. Pregnancy, labour and delivery, postpartum, and newborn checklist will be completed. Students will complete a demographic and obstetric questionnaire that includes questions about age, education, occupation, gravidity, parity, abortions, live and dead children, last contraceptive method, intended and unintended pregnancies, last menstrual period (LMP), gestational age, date of birth, body mass index (BMI), previous pregnancy and childbirth records, high-risk behavior of the mother and father, current history of special care, test and ultrasound results, and participation in childbirth preparation class. Also, the following data will be recorded in the labor and delivery and post-partum checklist: checking the conditions of labor according to the partograph, length of labor, need for induction and the method used type of delivery, examination of perineal trauma, postpartum bleeding, and examination of the condition of the mother up to 6 weeks after delivery. In addition, the amount of bleeding will be checked visually and by measuring the level of hemoglobin and hematocrit. Apgar score of the newborn will be recorded (in infant checklist) in minutes 1 and 5. Also, the newborn’s hospitalization status, breastfeeding and anthropometric indices will be recorded.

The students in the intervention group will start prenatal care < 20 weeks of gestation. At least five round of prenatal care will be provided by each student according to national guidelines for each pregnant woman. Pregnant women can communicate with their in-charge students in non-emergency cases from 8:00 a.m. to 23:00 p.m. and in emergency cases 24 h a day, all days a week. All reports will be recorded by the students. During labor and delivery, the student and the lead researcher will be present at the mother's bedside. In case of natural vaginal delivery (NVD), delivery will be done by a student midwife under the supervision of the researcher. In case of cesarean delivery (CS), a student will be present at the patient's bedside. Postpartum care will be provided by midwifery students in both groups (intervention and control). Each student will be at the mother's bedside for two hours after delivery. The conditions of labor, delivery, and the neonate will be recorded by the student in the relevant form. Also, the mother will be followed up by telephone for up to 6 weeks after delivery (postpartum). The clinical competency questionnaire will be completed by students before and after the intervention.

Inclusion criteria

Inclusion criteria for midwifery students will be: studying at the seventh and eighth semester and willingness to participate in the study.

Inclusion criteria for service recipients (pregnant women) will be: age 18 – 40 years, Iranian nationality, singleton pregnancy, low risk pregnancy, and gestational age < 20 wks.

Exclusion criteria

Exclusion criteria will be: history of psychiatric disorders, previous caesarean section, use of alcohol and tobacco, or having a disease that requires prenatal care by a specialist.

Primary outcome

Clinical competence of midwifery students.

Secondary outcome

Mode of delivery, length of labor stages, the need to induction, postpartum bleeding first and fifth minute Apgar score, admission of neonate to the neonatal intensive care unit, breastfeeding initiation, and exclusive breastfeeding up to 6 weeks postpartum.

Data analysis

Statistical analyses will be done using SPSS version 26.0 (SPSS, Inc., Chicago, IL, USA). The independent t-test and Chi-square tests will be used for continuous data and categorical data, respectively. ANCOVA test will be used to eliminate the influence of confounding variables. The effect size will be calculated. A 95% confidence interval (CI) and p values will be reported. P -values less than 0.5 will be considered statistically significant.

Third step of research: qualitative study

This phase will be a qualitative study using conventional content analysis.

Purposeful sampling will be used in this study [ 33 ]. Sampling will continue until data saturation [ 34 ], i.e., no new information or data about a class or relationships between classes is revealed.

This phase of the study is a conventional qualitative content analysis [ 35 ] aimed at examining the perceptions of midwifery students and mothers receiving continuous care. The researcher will conduct in-depth, semi-structured interviews with open-ended questions with students and mothers in the group of the continuous care program. All interviews will be done by the lead researcher who is qualified in qualitative research method. The interview will start with a general and open question such as: “Please tell me about your experiences or feelings about participating in the continuous midwifery care program. How did you feel about participating in this program?” Then, in-depth exploratory questions will be asked based on their answers (e.g., what do you mean? Why? Can you elaborate on that? Can you give me an example so I can understand what you mean?). All interviews will be recorded with the participants' consent. Paralinguistic features, such as mood and features of the participants, including tone of voice, facial expressions, and their posture, will be recorded by the researcher during the interview [ 35 ].

The data will be analyzed based on Granheim and Lundman's 2004 content analysis approach [ 36 ].

Interviews will be transcribed at the end of each interview. Data analysis begins with a careful study of all data so that the researcher can immerse herself in the data and gain an overview. Interviews will be transcribed verbatim. Key concepts will be highlighted and codes will be extracted. Then the first interpretations will be made and analyzed. Labels emerge for codes that represent more than one key concept and are usually taken directly from the text and become the initial coding map. Then the codes are placed in the category based on their similarity. Then, definitions will be created for each category, subcategory and code. When reporting findings, examples of each code and data category will be provided [ 35 ].

Inclusion criteria for midwifery students will be: studying at the seventh or eighth semester, willingness to participate in the study.

Inclusion criteria for service recipients (pregnant women) will be: receiving continuous care provided by the student, willingness to participate in the study, and being able to communicate.

The qualitative study and interview data will be analyzed based on the content analysis approach of Granheim and Lundman 2004 [ 36 ] as follows:

Reading and re-reading the interviews after completion of each interview

Selection of the unit of analysis

Determination of semantic units

Classification

Extraction of information content

In the first step, the data is converted into text format. As soon as possible after the interview, the interview will be typed verbatim. Then the whole text will be read several times to get a general understanding of the content of interview. Each meaning unit will be converted into condensed meaning units and then coded. The Codes will be classified into subcategories and categories based on their common characteristics. Finally, the content of the categories will be revealed, taking into account their hidden meaning [ 36 ].

Trustworthiness

Five criteria of will be used to increase data trustworthiness according to Lincoln & Guba [ 37 ]. These include: 1. Credibility, 2. Dependability, 3. Confirmability, 4. Transferability, 5. Authenticity.

Credibility of the data will be ensured by continuous engagement of the researchers with the subject, member checks, and external checks. Dependability will be ensured by relying on the insight of external observers. In order to increase the confirmability, data will be accurately recorded and reported. Also, transferability will be ensured by presenting the research process accurately, clearly and purposefully, which includes purposive sampling and presenting the research results to a number of people with the same profile of the participants who did not participate in the research. Finally, authenticity will be guaranteed by continuous reflection on information, long-term presence of the researcher, interview recording, writing, and reporting of findings.

Combining qualitative and quantitative phases

Data combination will be done using data integration strategies. The integration or combination of data starts from quantitative data analysis. Then qualitative data is collected by interview. In fact, the qualitative study is a secondary source of embedded data in the collection of experimental test data (continuous care) after the quantitative study. In this research, in order to understand the results of the RCT, the views of the participants will be unified in order to get a correct understanding of the intervention (implementation of the continuity of care model by the students) from the mothers' and students' point of view (Fig.  2 ).

Study diagram

Study status

The development of the evaluation tools was made. Also, sampling the quantitative phase of the study and the basic of the program are in process (Table 1 ).

This is the first mixed-methods study to be conducted in Iran investigating the effect of a midwifery continuity of care program on clinical competence of midwifery students and pregnancy outcomes. According to the recommendations of the WHO, midwifery continuity of care should be adopted in order to increase the quality of pregnancy care as well as the satisfaction of pregnant women and service providers [ 7 ]. Contrary to the recommendation of WHO, the continuous care program is neither implemented in Iran's health system nor included in the midwifery curriculum. The results of this study can help health planners and policy makers to implement high quality midwifery care program based on global recommendations.

The study has several strengths. The use of a mixed-methods study design (combination of quantitative and qualitative approaches) in contrast to the separate use of quantitative and qualitative studies provides a better understanding of the research questions [ 38 ]. In embedded design, one type of data collection (quantitative or qualitative) plays a supporting and essential role for another type. As a result, the embedded mixed-methods technique in the qualitative phase after designing the intervention will be used to receive feedback from the participants to confirm and support the findings of quantitative phase [ 39 ]. Also, interviews with mothers and midwifery students in the intervention group can reflect their positive and negative experiences of this program. Considering that Iran's healthcare system lacks continuous midwifery care, the findings of this research can be effectively used in providing conventional midwifery services in public centers and in midwifery education.

Considering that this care model will be implemented for the first time in Iran's midwifery education and healthcare system, there may be two possible limitations in this study: lack of infrastructure and interference with other educational programs.

Availability of data and materials

All the data that will be obtained will be published in the next article after the implementation of the study.

Abbreviations

Body mass index

Cesarean section

Last menstrual period

Millennium Development Goals

Natural vaginal delivery

World Health Organization

Bagheri A, Simbar M, Samimi M, Nahidi F, Majd HA. Exploring the concept of continuous midwifery-led care and its dimensions in the prenatal, perinatal, and postnatal periods in Iran (Kashan). Midwifery. 2017;51:44–52.

Article   Google Scholar  

Cummins A, Coddington R, Fox D, Symon A. Exploring the qualities of midwifery-led continuity of care in Australia (MiLCCA) using the quality maternal and newborn care framework. Women Birth. 2020;33(2):125–34.

Choudhary S, Jelly P, Mahala P. Models of maternity care: a continuity of midwifery care. Int J Reprod Contracept Obstet Gynecol. 2020;9(6):2666–70.

Bradford BF, Wilson AN, Portela A, McConville F, Fernandez Turienzo C, Homer CS. Midwifery continuity of care: a scoping review of where, how, by whom and for whom? PLOS Global Public Health. 2022;2(10):e0000935.

Lettink A, Chaibekava K, Smits L, Langenveld J, van de Laar R, Peeters B, et al. CCT: continuous care trial-a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands. BMC Pregnancy Childbirth. 2020;20(1):1–6.

Chaibekava KV, Scheenen AJ, Lettink A, Smits LJ, Langenveld J, Van De Laar R, et al. Continuous care during labor by maternity care assistants in the Netherlands vs care-as-usual: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023;5(11):101168.

Michel-Schuldt M, McFadden A, Renfrew M, Homer C. The provision of midwife-led care in low-and middle-income countries: an integrative review. Midwifery. 2020;84:102659.

Khosravi S, Babaey F, Abedi P, Kalahroodi ZM, Hajimirzaie SS. Strategies to improve the quality of midwifery care and developing midwife-centered care in Iran: analyzing the attitudes of midwifery experts. BMC Pregnancy Childbirth. 2022;22(1):40.

Donnellan Fernandez R, Scarf V, Devane D, Healey A. Is Midwifery Continuity of Care Cost Effective? Midwifery Continuity of Care. Elsevier; 2019.  p. 137–56.

Aune I, Tysland T, Amalie VS. Norwegian midwives’ experiences of relational continuity of midwifery care in the primary healthcare service: a qualitative descriptive study. Nordic J Nurs Res. 2021;41(1):5–13.

Hanley A, Davis D, Kurz E. Job satisfaction and sustainability of midwives working in caseload models of care: an integrative literature review. Women Birth. 2022;35(4):e397–407.

Grylka-Baeschlin S, Iglesias C, Erdin R, Pehlke-Milde J. Evaluation of a midwifery network to guarantee outpatient postpartum care: a mixed methods study. BMC Health Serv Res. 2020;20:1–12.

Evans J, Taylor J, Browne J, Ferguson S, Atchan M, Maher P, et al. The future in their hands: graduating student midwives’ plans, job satisfaction and the desire to work in midwifery continuity of care. Women Birth. 2020;33(1):e59–66.

Carter J, Sidebotham M, Dietsch E. Prepared and motivated to work in midwifery continuity of care? A descriptive analysis of midwifery students’ perspectives. Women Birth. 2022;35(2):160–71.

Inoue N, Nakao Y, Yoshidome A. Development and validity of an intrapartum self-assessment scale aimed at instilling midwife-led care competencies used at freestanding midwifery units. Int J Environ Res Public Health. 2023;20(3):1859.

Vázquez-Sánchez C, Gigirey L, editors. Design of a scoring rubric for the assessment of clinical competencies in the subject of optometry IV of the degree of optics and optometry-USC. INTED2023 Proceedings. Valencia: IATED; 2023. p. 2224–30. https://doi.org/10.21125/inted.2023.0613 .

Kubota S, Ando M, Murray J, Khambounheuang S, Theppanya K, Nanthavong P, et al. A regulatory gap analysis of midwifery to deliver essential reproductive, maternal, newborn, child and adolescent health services in Lao People’s Democratic Republic. Lancet Reg Health West Pac. 2024;43:1–10. https://doi.org/10.1016/j.lanwpc.2023.100959 .

Pazandeh F, Moridi M, Safari K. Labouring women perspectives on mistreatment during childbirth: a qualitative study. Nursing Ethics. 2023;30(4):513–25. https://doi.org/10.1177/09697330231158732 .

Abbasi A, Bazghaleh M, FadaeeAghdam N, Basirinezhad MH, Tanhan A, Montazeri R, et al. Efficacy of simulated video on test anxiety in objective structured clinical examination among nursing and midwifery students: a quasi-experimental study. Nurs Open. 2023;10(1):165–71.

Farokhi F. Quality assessment of midwives performance in prenatal cares in urban health centers in Mashhad, Iran. Payesh (Health Monitor). 2008;7(3):0.

Google Scholar  

Moradali MR, Hajian S, Majd HA, Rahbar M, Entezarmahdi R. Job Satisfaction and its Related Factors in Midwives Working in the Health Services System in Iran: A Systematic Review. J Midwifery Reprod Health. 2023;11(2):3650–63. https://doi.org/10.22038/jmrh.2023.64824.1890 .

Hainsworth N, Cummins A, Newnham E, Foureur M. Learning through relationships: the transformative learning experience of midwifery continuity of care for students: a qualitative study. Women Birth. 2023;36(4):385–92.

Lazar J. Exploring the experiences of midwives facilitating group antenatal care: City, University of London; 2023.

Adelson P, Fleet J-A, McKellar L. Evaluation of a regional midwifery caseload model of care integrated across five birthing sites in South Australia: women’s experiences and birth outcomes. Women Birth. 2023;36(1):80–8.

Prussing E, Browne G, Dowse E, Hartz D, Cummins A. Implementing midwifery continuity of care models in regional Australia: a constructivist grounded theory study. Women Birth. 2023;36(1):99–107.

Pintubatu J. keterampilan proses sains pada pembelajaran ipas berorientasi outdoor learning siswa SMK Negeri 1 Lolak. Charm Sains: Jurnal Pendidikan Fisika. 2023;4(1):7–12.

Creswell JW. Controversies in mixed methods research. Sage Handbook Qual Res. 2011;4(1):269–84.

Kristensen SB, Clausen A, Skjødt MK, Søndergaard J, Abrahamsen B, Möller S, et al. An enhanced version of FREM (Fracture Risk Evaluation Model) using national administrative health data: analysis protocol for development and validation of a multivariable prediction model. Diagn Progn Res. 2023;7(1):19.

Alabi AT, Jelili MO. Clarifying likert scale misconceptions for improved application in urban studies. Qual Quant. 2023;57(2):1337–50.

Roopashree MR. A pragmatic approach for the calculation content validity indices: a study on validation of training tool for pre and post-test questionnaire for the health care sector. QAI J Healthc Qual Patient Saf. 2023;4(1):17–23.

Martyushev NV, Malozyomov BV, Sorokova SN, Efremenkov EA, Valuev DV, Qi M. Review models and methods for determining and predicting the reliability of technical systems and transport. Mathematics. 2023;11(15):3317.

Hildingsson I, Karlström A, Haines H, Johansson M. Swedish women’s interest in models of midwifery care–Time to consider the system? A prospective longitudinal survey. Sex Reprod Healthc. 2016;7:27–32.

Creswell JW, Creswell JD. Research design: Qualitative, quantitative, and mixed methods approaches. 3rd ed. SAGE Publications Inc.; 2017.

Obilor EI. Convenience and purposive sampling techniques: are they the same. Int J Innov Soc Sci Educ Res. 2023;11(1):1–7.

Serafini F, Reid SF. Multimodal content analysis: expanding analytical approaches to content analysis. Vis Commun. 2023;22(4):623–49.

Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24(2):105–12.

Lincoln YS, Guba EG. Naturalistic inquiry. SAGE Publications; 1985.

Matović N, Ovesni K. Interaction of quantitative and qualitative methodology in mixed methods research: integration and/or combination. Int J Social Res Methodol. 2023;26(1):51–65.

Creswell JW, Clark VLP. Designing and conducting mixed methods research. SAGE Publication, Inc; 2017.

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The study was funded by Ahvaz Jundishapur University of Medical Sciences.

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Midwifery Department, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Fatemeh Razavinia

Midwifery Department, Menopause Andropause Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Midwifery Department, Menopause Andropause Research Center, Ahvaz Jundisahpur University of Medical Sciences, Golestan BLvd, Ahvaz, Iran

Parvin Abedi

Reproductive Health Promotion Research Center, Midwifery Department, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Mina Iravani

Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

Eesa Mohammadi

Alimentary Tract Research Center, Clinical Sciences Research Institute, Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Bahman Cheraghian

MPH Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, USA

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Department of Obstetrics and Gynecology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

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Contributions

FR, PA, MI, EM, BCh, ShJ and MN conceptualized the study. FR will collect the data. FR drafted the protocol. PA revised the manuscript. The authors read and approved the final manuscript.

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Correspondence to Parvin Abedi .

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This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1401.460). Also, the study protocol was registered in the Iranian Registry for Randomized Controlled Trials (IRCT20221227056938N1). Informed consent will be obtained from all participants. The study’s findings will be shared via the publishing of peer-reviewed articles, talks at scientific conferences and meetings with related teams.

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Razavinia, F., Abedi, P., Iravani, M. et al. The effect of a midwifery continuity of care program on clinical competence of midwifery students and delivery outcomes: a mixed-methods protocol. BMC Med Educ 24 , 338 (2024). https://doi.org/10.1186/s12909-024-05321-5

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• Continuity of care
• Clinical competence
• Mixed-methods
• Midwifery students
• Pregnancy outcomes

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Effects of chronic physical exercise on executive functions and episodic memory in clinical and healthy older adult populations: a systematic review and meta-analysis protocol

• Soledad Ballesteros   ORCID: orcid.org/0000-0002-8391-9615 1 ,
• Michel Audifren 2 ,
• Andreea Badache 3 ,
• Vera Belkin 4 ,
• Christoforos D. Giannaki 5 ,
• Antonia Kaltsatou 6 ,
• Uros Marusic 7 ,
• Mohammad Mosaferi Ziaaldini 8 ,
• Manca Pescar 7 , 12 ,
• José M. Reales 9 ,
• Jennifer A. Rieker 10 ,
• Pinelopi S. Stavrinou 5 ,
• Juan Tortosa-Martinez 11 ,
• Claudia Voelcker-Rehage 4 &
• Yael Netz 13 , 14  

Systematic Reviews volume  13 , Article number:  98 ( 2024 ) Cite this article

Metrics details

Executive functions (EFs) and episodic memory are fundamental components of cognition that deteriorate with age and are crucial for independent living. While numerous reviews have explored the effect of exercise on these components in old age, these reviews screened and analyzed selected older adult populations, or specific exercise modes, thus providing only limited answers to the fundamental question on the effect of exercise on cognition in old age. This article describes the protocol for a systematic review and multilevel meta-analytic study aiming at evaluating the effectiveness of different types of chronic exercise in improving and/or maintaining EFs and long-term episodic memory in older adults.

Methods and analysis

The study protocol was written in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Several databases will be searched. Randomized controlled trials (RCTs) conducted in older adults aged ≥ 60 years providing any kind of planned, structured, and repetitive exercise interventions, and EFs and/or episodic memory measures as outcomes, published in English in peer-reviewed journals and doctoral dissertations will be included. Two independent reviewers will screen the selected articles, while a third reviewer will resolve possible conflicts. The Cochrane risk-of-bias tool will be used to assess the quality of the studies. Finally, data will be extracted from the selected articles, and the formal method of combining individual data from the selected studies will be applied using a random effect multilevel meta-analysis. The data analysis will be conducted with the metafor package in R.

Discussion and conclusion

This review will synthesize the existing evidence and pinpoint gaps existing in the literature on the effects of exercise on EFs and episodic memory in healthy and unhealthy older adults. Findings from this meta-analysis will help to design effective exercise interventions for older adults to improve and/or maintain EFs and episodic memory. Its results will be useful for many researchers and professionals working with older adults and their families.

Systematic review registration

PROSPERO CRD42022367111.

Peer Review reports

Introduction

Developed nations are experiencing unprecedented increases in the population of older adults mostly due to the reduced birth rates and the increased longevity of their citizens. The latest projections by the United Nations suggest that the global population could grow to around 8.5 billion in 2030, 9.7 billion in 2050, and 10.4 billion in 2100 [ 1 ]. More importantly, it was estimated that in the European Union, the old-age dependency will increase from 29.6% in 2016 to 51.2% in 2070 [ 2 ].

With respect to brain and cognition, aging is the main risk factor for neurodegeneration with prevalence increasing further with age [ 3 ]. Given the demographic situation and the relation of aging with cognitive decline, there is great interest in exploring effective ways to improve and/or maintain cognitive functions for independent living [ 4 ]. The main approaches to improving brain functionality and cognition in older adults are physical activity (PA), cognitive training, and social engagement [ 5 ]. The focus of this paper is PA.

Colcombe and Kramer [ 6 ] conducted two decades ago a seminal meta-analytic study on the effect of aerobic fitness on cognition in older adults. The study included 18 intervention studies and showed robust benefits in cognition with the largest fitness-induced benefits occurring for executive control processes, as previously hypothesized by Kramer, Hahn et al. [ 7 ]. The magnitude of the effect was moderated by the length of the training intervention, the length of the training sessions, the type of the intervention, aerobic training or aerobic combined with strength training with better results for combined training, and the gender of the participants with larger benefits for women.

The research conducted since then has provided compelling evidence that regular practice of PA can promote and/or maintain cognitive and brain functioning in late adulthood and old age [ 8 , 9 , 10 ]. The literature usually distinguishes between PA and exercise. The former entails any bodily movement produced by skeletal muscles that increases energy expenditure relative to rest. Exercise is a subcategory of PA that is planned, structured, and repetitive and is more specifically designed to improve one or more components of fitness: cardiorespiratory fitness, flexibility, balance, coordination, strength, and/or power [ 11 ].

The main objective of this review focuses on analyzing the effect of various exercise interventions, including aerobic exercise, strength straining, dance, and balance exercises on executive functions (EFs) and episodic memory of older adults. There is agreement among aging researchers that significant declines appear with age in EFs [ 8 , 12 ] and long-term episodic memory, related to intentional retrieval of episodes [ 13 , 14 ]; thus, several studies focus on these components [ 15 , 16 , 17 , 18 ]. EFs are formed by a series of effortful top-down cognitive processes necessary for mental and physical health, success in life, and cognitive, social, and psychological development [ 19 ]. The dorsolateral prefrontal cortex (DLPFC) plays a crucial role in the different components of EFs [ 20 ] and contributes to these components via functional connectivity with different brain regions [ 21 ].

Improvements in fitness are expected to improve EF processes such as coordination, inhibition, planning, and updating of working memory [ 7 ] but also cognitive flexibility as well as higher-order executive functions related to reasoning and fluid intelligence. Inhibitory control refers to the ability to control one’s attention and do what is more appropriate in each circumstance. Moreover, inhibitory control allows us to selectively attend to a certain stimulus suppressing other stimuli. Self-control is another aspect of inhibitory control related to resisting temptations and avoiding impulsivity. Inhibitory control declines greatly in normal aging [ 22 ], and older adults struggle to avoid distractions [ 23 ]. A recent cross-sectional study has showed that the EFs inhibition, shifting, updating, and dual tasking decline in healthy older adults but not with the same intensity with inhibition showing the greatest decline and dual tasking the smallest [ 24 ].

Working memory (WM), and more particularly updating of WM, is another key EF that serves to hold verbal or visual-spatial information in mind that is no longer perceptually present and working with it [ 25 ]. WM and inhibitory control are closely related and often support one another. The decline in WM with aging correlates with a decrease in the speed of information processing in older adults [ 26 , 27 ].

The third component of EFs, cognitive flexibility, builds on working memory and inhibitory control. Flexibility means to being able to adjust to changed demands and to change perspectives, task switching, and set shifting. Cognitive flexibility is a property of the cognitive system that helps us to pursue complex tasks [ 28 ]. An additional component of EFs is higher-order EFs which is related to reasoning, problem-solving, and planning and is synonymous with fluid intelligence [ 19 ].

Episodic memory is a key cognitive process that allows us to represent past experiences and employ these representations to serve current and future goals [ 29 , 30 ]. It is one of the earliest memory systems that decline with increasing aging. Impaired episodic memory with aging, involving retrieval of personal experiences and their spatial and temporal contexts, is well documented in the literature [ 31 ]. At the brain level, the medial temporal lobe and the hippocampus play a crucial role in retrieving information from episodic memory [ 32 ].

Since the influential meta-analytic study conducted by Colcombe and Kramer [ 6 ], the effect of exercise on EFs and episodic memory has been examined in numerus meta-analyses [ 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 ]. However, some reviews included only healthy populations [ 39 , 40 , 46 ], while others included only cognitively impaired or demented older adults [ 34 , 35 , 41 , 43 , 44 , 48 ]. Chen et al. [ 36 ] included both healthy and cognitively impaired older adults but not demented. While one review examined only nursing home residents [ 38 ], another review [ 45 ] included only community-dwelling older adults. On the other site, while one review [ 33 ] focused only on aerobic exercise, another review [ 37 ] centered merely on resistance training, yet a third one [ 42 ] focused on exergames.

The current study addresses the gaps of the existing literature and aims to extend the knowledge of the effect of exercise on the principal components of cognition in old age. Our comprehensive review will potentially include healthy and non-healthy older adults and a wide range of exercise modes. This argument stems from a gap in evidence-based literature as pointed in a recent article [ 49 ]. For example, it has been argued that research on older populations is typically biased towards healthy and relatively young older adults, with certain groups of older individuals frequently being excluded from research on aging — especially in studies with physical activity interventions [ 49 ]. Such a review will pose a general question on the effect of exercise on cognition in advanced age (a general effect size will be calculated) followed by examining the moderating effect of various exercise modes (e.g., aerobics, strength, balance), several exercise characteristics (e.g., intensity, frequency, length), and a wide range of population characteristics (e.g., education level, percentage of females, health status), protocol characteristics (e.g., type of control group, type of analysis — intention-to-treat vs. per-protocol), and exercise settings (community dwelling and nursing homes). In addition, the present review will make an in-depth examination of the moderating effect of the outcomes used to assess cognitive functions, distinguishing, for example, working memory span indexes (e.g., number of correct responses in reading span tasks) from updating working memory indexes (e.g., error rate in n-back tasks), the latter requiring much more executive control than the former. The choice of adequate indexes of EFs is a very sensitive problem when estimating the effect size of the influence of regular exercise on EFs.

To summarize, the main objective of this systematic review and meta-analysis is to address the gaps encountered in the existing literature and to investigate the advantages of a broad range of exercise interventions on two key cognitive components, EFs and long-term episodic memory, across diverse groups of older adults and considering very selective outcomes. The findings from this review will be instrumental in developing effective training methods to enhance EFs and episodic memory in healthy and unhealthy older adults.

The protocol of this review was prepared following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) 2015 statement and Cochrane systematic review methodology [ 50 , 51 ]. The protocol is registered on the International Prospective Register of Systematic Reviews (number CRD42022367111).

Figure  1 presents the planned flow chart of the systematic review and meta-analysis with a summary of the selection process.

Flow chart diagram of the search strategy of the systematic review

Eligibility criteria

Eligibility criteria follows the PICO framework regarding population, intervention, comparator, outcome, and study type.

The study will include participants with a mean age of 60 years or older and a minimum age of 50 years. It will include both healthy older adults and older adults diagnosed with various conditions such as mild cognitive impairment (MCI), Alzheimer’s disease (AD), or Parkinson disease (PD).

Intervention

Any randomized controlled trial (RCT) focusing on the effects of any type of exercise will be screened for inclusion, including aerobic, resistance training, coordination training, and other exercise programs such as tai chi, qigong, dancing, and exergaming. Several main exercise characteristics (type, session duration, session intensity, session frequency, intervention duration) will be assessed.

Comparators

Comparators will include light exercise, stretching, meditation, relaxation, and/or passive control groups (waiting list, treatment as usual, and habitual activities).

Cognitive outcomes will include objectively assessed cognitive domains of EFs (inhibition, working memory, cognitive flexibility, and high-level EFs) and episodic memory. These cognitive domains should have been assessed at baseline and at the end of the intervention through well-validated cognitive tasks and psychological tests. Regarding EFs, the outcomes for assessing inhibitory control may include the Stroop task, Eriksen-Flanker test, Simon task, global–local task, go-no go task, random number generation task, saccade-antisaccade task, and stop-signal task (STT). To assess working memory, the tasks and tests may include the Corsi block-tapping test, reading span task (RST), operation span task (OSpan), backward verbal digit span task, visuospatial N-back task, or tone monitoring task. To assess cognitive flexibility, the instruments may include the Trial Making Test (TMT), the Alternative Uses Task (AUT), Brixton Spatial Anticipation Test (BSAT), Delis-Kaplan Executive Function System (D-KEFS, subtests: the Trail Making Test, the Color-Word Test, the Tower Test, the design fluency test, The Sorting Test), Remote Associates Test (RAT), Implicit Relational Assessment Procedure (IRAP), attentional set-shifting task (AST), or Wisconsin Card Sorting Test (WCST). Among the instruments to assess high-level executive functions are the Raven’s Colored Progressive Matrices (RCPM) and Tower of Hanoi (TOH). In the case of episodic memory, the assessment tools may include the Rey Auditory Verbal Learning Test (RAVLT), SEMantic Episodic Memory Test (SEMEP), Wechsler Memory Scale (WMS; only the subtests that assess episodic memory), Hopkins Verbal Learning Test (HVLR-R), language-based paradigms, or the 360° video for episodic memory assessment. All the indexes of performance used for each of these tasks will be carefully selected to be sure that they reflect the targeted cognitive function (e.g., interference score in the case of the Stroop task, the Ericksen task, and the Simon task).

Inclusion and exclusion criteria

The inclusion criteria will be age (mean ≥ 60 with a minimum of 50 years), the practice of any type of physical exercise for at least 3 months, and provide outcomes including any EFs or episodic memory measure assessed at baseline (before physical training) and after training (post-training). If there were enough follow-up studies (e.g., 3 months, 6 months after training), they will be analyzed. Characteristics of exercise intervention such as frequency, intensity, type, and/or time of exercise (FITT) of the intervention program will have to be informed. Studies will be excluded if they do not meet the PICO conditions mentioned above, if they are not RCTs, if they do not have at least an active or passive control group, or if the written language is not English.

Research questions

The present study is directed to answer six main research questions described below.

To what extent does exercise enhance EFs and episodic memory in old age (the global effect)?

Do different types of chronic exercise (aerobic, resistance training, coordination training, and other exercise programs, such as Tai Chi or Qigong, dancing, or exergaming) have a different impact on EFs and episodic memory in older adults?

Is the type of control group (active vs. passive) a moderator of the changes in the investigated cognitive domains?

Is the effect of exercise different in healthy older adults and clinical older adults suffering neuropsychological disorders (MCI, PD, AD)?

Is age a moderator of the effect of exercise on the investigated components of cognition?

Are duration and intensity of exercise moderators of the effect of regular exercise on cognitive aging?

Literature search strategy

An initial search will be conducted at MEDLINE, Embase, PsychINFO, Google Scholar, EBSCO, SportDiscuss, CINAHL, Science Direct Dissertations, Web of Science, and Cochrane Central Registered of Controlled Trials (CENTRAL). These databases were selected because they are the most important and widely used to assure that relevant articles were not missed and in consultation with experienced researchers and librarians. Table 1 shows the detailed search strategy for PsychINFO. In addition, systematic reviews and meta-analyses published on episodic memory and the different EFs processes will be screened to check if the articles included in these publications should be considered in the present review.

Inclusion will be restricted to articles written in English published in peer-reviewed journals and doctoral theses. Studies published in other language will not be included. English is the most widely used scientific language to publish intervention studies and the language used in most systematic reviews and meta-analytic studies. Articles published from the inception will be considered for inclusion. An additional final search in the different databases will be conducted at the end of the review process to include more recently published studies.

After carefully reading all the retrieved articles, the data will be extracted for conducting the meta-analyses.

Data extraction

Once the databases are searched, the retrieved articles will be exported in a Research Information Systems (RIS) format and imported into Rayyan [ 52 ], a web application created for article screening. The first step in Rayyan will consist of removing all the duplicates. Then, pairs of reviewers will work independently and blinded on screening articles based on title and abstract. Possible conflicts between the two independent reviewers will be solved by a third reviewer (J. M. R.). After completing the first selection stage by title and abstract, the next step will be retrieving the full articles corresponding to the included articles for careful reading. The idea is to extract in an Excel spreadsheet all the relevant information. The extracted data will include the following: (i) Characteristics: information regarding author(s), journal, publication year, and country; (ii) population: number of participants in each group, participants’ characteristics including mean age, sex, and clinical condition; (iii) interventions: including type of physical activity, intensity, session duration, total duration of the intervention, and adherence; and (iv) outcomes: in terms of tasks and psychological instruments used to assess memory and EFs, including sample size, means, and standard deviations at baseline and post-intervention and other possible time points corresponding (follow-up assessments) to the different (intervention and control) groups.

If a study will be relevant for our analysis but the data necessary to calculate the effect sizes will be missing or just the graphs were available, we will contact the corresponding author by email to ask for the relevant data. If the author does not respond, the missing data will be extracted from the graphs provided in the article using the online tool WebPlotDigitizer version 4.3.

In the case of RCTs with several time points, we will focus on the post-intervention at the end of the physical exercise training. If more time points or follow-up assessments were provided and enough articles contained assessments at 3 or 6 months after the end of the intervention program, the effects will also be considered. We will calculate Hedges’s g as the effect size.

Risk of bias

The risk of bias (RoB) of each included study will be evaluated using the Cochrane ROB 2 tool [ 50 , 53 , 54 ]. Biases are assessed across five areas including randomization, deviations from intended interventions, missing outcome data, outcome measurement, and selection of the reported results. The risk of bias of each study will be assessed based on a series of questions provided for each of the five areas and the possible answers in the following five categories: “yes,” “probably yes,” “no,” “probably no,” and “no information.” Finally, the risk of bias in each area will be assessed as “low risk of bias,” “some concerns,” or “high risk of bias.” Teams of two reviewers will independently assess the risk of bias in the included studies. A third independent reviewer will resolve possible disagreements.

Statistical analysis

Effect sizes (ES) will be modelled using a three-level structure because it is a better approach than a two-level structure when there are several dependent effect sizes in each independent study but only if the heterogeneity of the sampling variance is substantial. In three-level meta-analytic models, three different sources of variance are modelled. The third level represents the variance of effect sizes between studies; the second level describes the variance of effect sizes of the experiments, or measurements nested within each study; and the first level describes the sample variance. In the present study, we will perform a multilevel random-effects analysis using restricted maximum likelihood estimation. This analytical solution was designed to account for the nonindependence among effect sizes. This is the preferred methodology when the sampling variability is not too high. Heterogeneity among effect sizes ( I 2 ) will be assessed using the omnibus homogeneity test (Q), 0–40% indicates negligible heterogeneity, 30–60% indicates moderate heterogeneity, and 50–90% suggests substantial heterogeneity. A large Q -value means that differences between effect sizes do not derive from a common population mean from the study samples but are accounted for by other reasons.

The statistical analysis will be performed using rma.mv function of the metaphor package (version 2.4) [ 55 ] within the R software environment (version 4.0.1; R Core Team, 2021) [ 56 ]. The analytical steps provided by Assink and Wibbelink [ 57 ] will be followed. Dot-plot figures will be depicted using Mathematica (version 10.4) with software developed specifically for the present study.

To avoid outliers or influential cases that could distort the results of the meta-analysis, outlier and influential case diagnostics will be performed using the influence function of the metaphor package. The influence function calculates the influence of deleting one case at a time on the model fit or the fitted/residual values. Statistical heterogeneity will be assessed using the I 2 test.

After a systematic publication search, it might occur that some studies were missed due to publication bias. That is, intervention studies that did not obtain significant results are not published, either because the authors did not submit them to a journal for publication or because the editor rejected them. We will address this important issue using two complementary statistics. The first explores the relationship between the precision and the observed effect size of the studies (the funnel plot and the statistical test of its asymmetry known as Egger’s regression test) under the assumption that effect sizes drive publication bias. In a funnel plot, the effect sizes are plotted against the standard error. An asymmetric funnel plot would suggest that publication bias exists, for example, an underrepresentation of nonsignificant results and/or negative effects on the bottom left side of the funnel plot. To evaluate the statistical significance of the funnel plots, we will apply the Egger’s test [ 58 ]. This test analyzes in a linear regression whether the standardized effect sizes can predict study precision, defined as the inverse of the standard error. The main goal of this analysis is to find a significant regression intercept that differs significantly from zero which would indicate a significant funnel plot asymmetry. We will also use the trim-and-fill method [ 59 , 60 ] to determine the number of effect sizes that would need to be imputed to restore the symmetry of the funnel plot.

The second statistics we are going to use to assess publication bias is the P-curve technique, which assumes that publication bias is driven primarily through p -values, not by effect sizes. This relatively new methodology is based on the shape of the histogram of p -values, which depends on the sample sizes of studies and the actual effect size of the data. The method determines if the data estimates an actual, non-spurious effect size.

Once we had all the required information regarding the types of interventions, comparators, outcomes, and the healthy or clinical conditions of the participants of the finally included studies, we would be able to provide information regarding search results, descriptive results corresponding to studies and participants’ characteristics, overall effect size, and moderator analyses.

The demographic data suggest that the world is aging very rapidly, and it is necessary to take actions against the cognitive decline that comes with aging. EFs and episodic memory are fundamental components of cognition that deteriorate with age and are vital for independent living. These cognitive declines significantly impact the performance of activities of daily living, independent living, and well-being among older adults. Previous reviews and meta-analyses screened and analyzed certain older adult populations [ 39 , 46 , 34 , 41 , 48 ], or specific type of exercise [ 33 , 37 , 42 ], providing limited answer to the question on the effect of exercise on EFs and episodic memory of older adults. The novelty of the present review is that it extends the knowledge about the effects of exercise on specific and central aspects of cognition to include different exercise modes and both healthy and unhealthy older adults.

Considering the key procedures and analyses, this systematic and meta-analytic review follows the PRISMA-P 2015 statement and the Cochrane systematic review methodology [ 50 , 51 ]. The eligibility criteria of the articles to be included follows the PICO framework (population, intervention, comparator, and outcomes). Articles that met the inclusion criteria will be carefully read by pairs of reviewers who will extract the data for conducting the meta-analysis. Hedges’s g will be calculated as the effect size. Risk of bias of the included studies will be assessed with the Cochrane ROB 2 tool [ 50 , 53 , 54 ] by pairs of reviewers.

If the heterogeneity of the sampling variance is substantial, effect sizes (ES) will be modelled using a three-level structure. This approach is superior than a two-level structure. In a three-level structure, the third level corresponds to the variance of effect sizes between studies, while the second level refers to the effect sizes of the experiments within each study. Finally, the first level describes the sample variance.

The statistical analysis will be conducted using rma.mv function of the metaphor package (version 2.4) within the R software environment (version 4.0.1; R Core Team 2021), following the analytical steps of Assink and Wibbelink [ 57 ]. A specific software developed for the present study will be used to depict dot-plot figures. We will address possible publication bias using two complementary statistics, the funnel plot and the Egger’s regression test. The trim-and-fill method [ 59 , 60 ] will reveal the number of effect sizes necessary to be imputed to restore the symmetry of the funnel plot.

The fact that this review includes only articles written in English may be a limitation. However, clearly, most studies are reported in English, and it is expected to extract very comprehensive information.

The central research question of this study is whether all training components recommended by official bodies are efficient for enhancing EFs and episodic memory and whether moderators, such as exercise program types and participants’ characteristics, could influence the effect size of the effect of regular exercise on cognitive aging [ 46 , 61 ].

This systematic review and multilevel meta-analysis will provide evidence on how to optimize physical activity programs to improve and/or maintain these cognitive functions that decline more with age. So, the results of the present study would contribute to identify the gaps and limitations of current physical exercise research on executive functions and episodic memory in older adults. It would also allow to understand the quality of the research conducted to date in this field and summarize its main findings. The findings of this study will be useful for clinicians, physical trainer specialists, psychologists, social workers, and gerontologists, as well as older adults, their families, and wider public.

Ethics and dissemination

This systematic review and meta-analytic study do not require approval from an ethics committee. The results will be disseminated in peer-reviewed journals and at international conferences and scientific meetings.

Abbreviations

Confidence intervals

• Executive functions
• Episodic memory

Frequency, intensity, type, and time of exercise

Mean difference

Physical activity

Standardized mean difference

Working memory

United Nations Department of Economic and Social Affairs PD. World Population Prospects 2022: Summary of Results. UN DESA/POP/2022/TR/NO. 3. University Press; 2022.

European Commission. The 2018 Ageing Report: economic and budgetary projections for the EU Member States. 2018.

Google Scholar  

Hou Y, Dan X, Babbar M, Wei Y, Hasselbalch SG, Croteau DL, et al. Ageing as a risk factor for neurodegenerative disease. Nat Rev Neurol. 2019;15(10):565–81.

Article   PubMed   Google Scholar  

Ballesteros S, Kraft E, Santana S, Tziraki C. Maintaining older brain functionality: a targeted review. Neurosci Biobehav Rev. 2015;55:453–77.

Ballesteros S, Voelcker-Rehage C, Bherer L. Editorial: cognitive and brain plasticity induced by physical exercise, cognitive training, video games, and combined interventions. Front Hum Neurosci. 2018;7:12.

Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003;14(2):125–30.

Kramer AF, Hahn S, Cohen NJ, Banich MT, McAuley E, Harrison CR, et al. Ageing, fitness and neurocognitive function. Nature. 1999;400(6743):418–9.

Article   CAS   PubMed   Google Scholar  

Audiffren M, André N. Exercise and aging. In: Sport, Exercise and Performance Psychology. UK: Oxford University Press; 2021. p. 238–49.

Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508.

PubMed   PubMed Central   Google Scholar  

Voelcker-Rehage C, Niemann C. Structural and functional brain changes related to different types of physical activity across the life span. Neurosci Biobehav Rev. 2013;37(9):2268–95.

Bangsbo J, Blackwell J, Boraxbekk CJ, Caserotti P, Dela F, Evans AB, et al. Copenhagen Consensus statement 2019: physical activity and ageing. Br J Sports Med. 2019;53(14):856–8.

Hoyer WJ, Verhaeghen P. Memory aging. In: Handbook of the Psychology of Aging. Amsterdam: Elsevier; 2006. p. 209–32.

Cabeza R, Nyberg L, Park DC. Cognitive neuroscience of aging: lining cognition and cerebral aging. UK: Oxford University Press; 2005.

Park DC, Lautenschlager G, Hedden T, Davidson NS, Smith AD, Smith PK. Models of visuospatial and verbal memory across the adult life span. Psychol Aging. 2002;17(2):299–320.

Kachouri H, Fay S, Angel L, Isingrini M. Influence of current physical exercise on the relationship between aging and episodic memory and fluid intelligence. Acta Psychol (Amst). 2022;227:103609.

Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010;170(2):170–8. Available from:   https://biblioproxy.uqtr.ca/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=mnh&AN=20101012&site=ehost-live .

Article   PubMed   PubMed Central   Google Scholar  

Moutoussamy I, Taconnat L, Pothier K, Toussaint L, Fay S. Episodic memory and aging: benefits of physical activity depend on the executive resources required for the task. PLoS ONE. 2022;17(2):e0263919.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Nouchi R, Taki Y, Takeuchi H, Sekiguchi A, Hashizume H, Nozawa T, et al. Four weeks of combination exercise training improved executive functions, episodic memory, and processing speed in healthy elderly people: evidence from a randomized controlled trial. Age (Dordr). 2014;36(2):787–99. Available from:  https://biblioproxy.uqtr.ca/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=mnh&AN=24065294&site=ehost-live .

Diamond A. Executive functions. Annu Rev Psychol. 2013;64(1):135–68.

Friedman NP, Miyake A. Unity and diversity of executive functions: Individual differences as a window on cognitive structure. Cortex. 2017;86:186–204.

Panikratova YR, Vlasova RM, Akhutina TV, Korneev AA, Sinitsyn VE, Pechenkova EV. Functional connectivity of the dorsolateral prefrontal cortex contributes to different components of executive functions. Int J Psychophysiol. 2020;151:70–9.

Hasher L, Zacks RT. Working memory, comprehension, and aging: a review and a new view. 1988. p. 193–225.

Gazzaley A, Cooney JW, Rissman J, D’Esposito M. Top-down suppression deficit underlies working memory impairment in normal aging. Nat Neurosci. 2005;8(10):1298–300.

Idowu MI, Szameitat AJ. Executive function abilities in cognitively healthy young and older adults—a cross-sectional study. Front Aging Neurosci. 2023;8:15.

Baddeley AD, Hitch GJ. Developments in the concept of working memory. Neuropsychology. 1994;8(4):485–93.

Article   Google Scholar  

Salthouse TA. Influence of processing speed on adult age differences in working memory. Acta Psychol (Amst). 1992;79(2):155–70.

Zimprich D, Kurtz T. Individual differences and predictors of forgetting in old age: the role of processing speed and working memory. Aging Neuropsychol Cogn. 2013;20(2):195–219.

Ionescu T. Exploring the nature of cognitive flexibility. New Ideas Psychol. 2012;30(2):190–200.

Tulving E. Elements of episodic memory. New York: Oxford University Press; 1983.

Tulving E. Episodic memory: from mind to brain. Annu Rev Psychol. 2002;53(1):1–25.

Rhodes S, Greene NR, Naveh-Benjamin M. Age-related differences in recall and recognition: a meta-analysis. Psychon Bull Rev. 2019;26(5):1529–47.

Rugg MD, Vilberg KL. Brain networks underlying episodic memory retrieval. Curr Opin Neurobiol. 2013;23(2):255–60.

Aghjayan SL, Bournias T, Kang C, Zhou X, Stillman CM, Donofry SD, et al. Aerobic exercise improves episodic memory in late adulthood: a systematic review and meta-analysis. Commun Med. 2022;2:15.

Balbim GM, Falck RS, Barha CK, Starkey SY, Bullock A, Davis JC, et al. Effects of exercise training on the cognitive function of older adults with different types of dementia: a systematic review and meta-analysis. Br J Sports Med. 2022;56(16):933–40.

Biazus-Sehn LF, Schuch FB, Firth J, de Stigger F S. Effects of physical exercise on cognitive function of older adults with mild cognitive impairment: a systematic review and meta-analysis. Arch Gerontol Geriatr. 2020;89:104048.

Chen FT, Etnier JL, Chan KH, Chiu PK, Hung TM, Chang YK. Effects of exercise training interventions on executive function in older adults: a systematic review and meta-analysis. Sports Med. 2020;50(8):1451–67.

Coelho-Junior H, Marzetti E, Calvani R, Picca A, Arai H, Uchida M. Resistance training improves cognitive function in older adults with different cognitive status: a systematic review and meta-analysis. Aging Ment Health. 2022;26(2):213–24.

Da Silva JL, Agbangla NF, Le Page C, Ghernout W, Andrieu B. Effects of chronic physical exercise or multicomponent exercise programs on the mental health and cognition of older adults living in a nursing home: a systematic review of studies from the past 10 years. Front Psychol. 2022;13:13.

Falck RS, Davis JC, Best JR, Crockett RA, Liu-Ambrose T. Impact of exercise training on physical and cognitive function among older adults: a systematic review and meta-analysis. Neurobiol Aging. 2019;79:119–30.

Gallardo-Gómez D, del Pozo-Cruz J, Noetel M, Álvarez-Barbosa F, Alfonso-Rosa RM, del Pozo CB. Optimal dose and type of exercise to improve cognitive function in older adults: a systematic review and Bayesian model-based network meta-analysis of RCTs. Ageing Res Rev. 2022;76:101591.

Huang X, Zhao X, Li B, Cai Y, Zhang S, Wan Q, et al. Comparative efficacy of various exercise interventions on cognitive function in patients with mild cognitive impairment or dementia: a systematic review and network meta-analysis. J Sport Health Sci. 2022;11(2):212–23.

Jiang J, Guo W, Wang B. Effects of exergaming on executive function of older adults: a systematic review and meta-analysis. PeerJ. 2022;11(10):e13194.

Lin M, Ma C, Zhu J, Gao J, Huang L, Huang J, et al. Effects of exercise interventions on executive function in old adults with mild cognitive impairment: a systematic review and meta-analysis of randomized controlled trials. Ageing Res Rev. 2022;82:101776.

Liu X, Wang G, Cao Y. Association of nonpharmacological interventions for cognitive function in older adults with mild cognitive impairment: a systematic review and network meta-analysis. Aging Clin Exp Res. 2023;35(3):463–78.

Northey JM, Cherbuin N, Pumpa KL, Smee DJ, Rattray B. Exercise interventions for cognitive function in adults older than 50: a systematic review with meta-analysis. Br J Sports Med. 2018;52(3):154–60.

Rieker JA, Reales JM, Muiños M, Ballesteros S. The effects of combined cognitive-physical interventions on cognitive functioning in healthy older adults: a systematic review and multilevel meta-analysis. Front Hum Neurosci. 2022;24:16.

Sanders LMJ, Hortobágyi T, la Bastide-van GS, van der Zee EA. van Heuvelen MJG Dose-response relationship between exercise and cognitive function in older adults with and without cognitive impairment: a systematic review and meta-analysis. PLoS ONE. 2019;14(1):e0210036. https://doi.org/10.1371/journal.pone.0210036 .

Venegas-Sanabria LC, Cavero-Redondo I, Martínez-Vizcaino V, Cano-Gutierrez CA, Álvarez-Bueno C. Effect of multicomponent exercise in cognitive impairment: a systematic review and meta-analysis. BMC Geriatr. 2022;22(1):617.

Brach M, de Bruin ED, Levin O, Hinrichs T, Zijlstra W, Netz Y. Evidence-based yet still challenging! Research on physical activity in old age. Eur Rev Aging Phys Act. 2023;20(1):7.

Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6. Vol. 4. Chichester: John Wiley & Sons, Ltd; 2006.

Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1.

Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan—a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210.

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;28:l4898.

Whiting P, Savović J, Higgins JPT, Caldwell DM, Reeves BC, Shea B, et al. ROBIS: a new tool to assess risk of bias in systematic reviews was developed. J Clin Epidemiol. 2016;69:225–34.

Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw. 2010;36(3):1–48.

R Core Team. A language and environment for statistical computing. Vienna R Foundation for Statistical Computing; 2021. http://www.R-project.org

Assink M, Wibbelink CJM. Fitting three-level meta-analytic models in R: a step-by-step tutorial. Quant Method Psychol. 2016;12(3):154–74.

Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629–34.

Duval S, Tweedie R. Trim and fill: a simple funnel-plot–based method of testing and adjusting for publication bias in meta-analysis. Biometrics. 2000;56(2):455–63.

Duval S, Tweedie R. A nonparametric “trim and fill” method of accounting for publication bias in meta-analysis. J Am Stat Assoc. 2000;95(449):89–98.

Netz Y. Is there a preferred mode of exercise for cognition enhancement in older age? A narrative review. Front Med (Lausanne). 2019;29:6.

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This article is the result of work from COST Action CA20104 — network on evidence-based physical activity in old age (PhysAgeNet), supported by COST (European Cooperation in Science and Technology). https://www.cost.eu , https://physagenet.eu/ . The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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SB, YN, MA, and CV-R conceptualized the design. SB wrote the original draft, and YN, MA, and CV-R reviewed and edited the draft. Funding acquisition, supervision, validation, and visualization were done by YN and SB. JMR and MA dealt with the methodology issues. All authors have taken part in initiating the idea, deciding the exercise types, the search terms, the specific measures of the outcomes, and the inclusion/exclusion criteria. All authors read and approved the final version of the manuscript.

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Ballesteros, S., Audifren, M., Badache, A. et al. Effects of chronic physical exercise on executive functions and episodic memory in clinical and healthy older adult populations: a systematic review and meta-analysis protocol. Syst Rev 13 , 98 (2024). https://doi.org/10.1186/s13643-024-02517-0

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Cost-effectiveness of severe acute malnutrition treatment delivered by community health workers in the district of Mayahi, Niger

• Elisa M. Molanes-López   ORCID: orcid.org/0000-0003-3217-8551 1 ,
• José M. Ferrer   ORCID: orcid.org/0000-0002-1021-1157 2 ,
• Abdias Ogobara Dougnon 3 ,
• Abdoul Aziz Gado 4 ,
• Atté Sanoussi 5 ,
• Nassirou Ousmane 5 ,
• Ramatoulaye Hamidou Lazoumar 6 &
• Pilar Charle-Cuéllar   ORCID: orcid.org/0000-0003-4784-5003 7  

Human Resources for Health volume  22 , Article number:  22 ( 2024 ) Cite this article

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A non-randomized controlled trial, conducted from June 2018 to March 2019 in two rural communes in the health district of Mayahi in Niger, showed that including community health workers (CHWs) in the treatment of severe acute malnutrition (SAM) resulted in a better recovery rate (77.2% vs. 72.1%) compared with the standard treatment provided solely at the health centers. The present study aims to assess the cost and cost-effectiveness of the CHWs led treatment of uncomplicated SAM in children 6–59 months compared to the standard national protocol.

To account for all relevant costs, the cost analysis included activity-based costing and bottom-up approaches from a societal perspective and on a within-trial time horizon. The cost-effectiveness analysis was conducted through a decision analysis network built with OpenMarkov and evaluated under two approaches: (1) with recovery rate and cost per child admitted for treatment as measures of effectiveness and cost, respectively; and (2) assessing the total number of children recovered and the total cost incurred. In addition, a multivariate probabilistic sensitivity analysis was carried out to evaluate the effect of uncertainty around the base case input data.

For the base case data, the average cost per child recovered was 116.52 USD in the standard treatment and 107.22 USD in the CHWs-led treatment. Based on the first approach, the CHWs-led treatment was more cost-effective than the standard treatment with an average cost per child admitted for treatment of 82.81 USD vs. 84.01 USD. Based on the second approach, the incremental cost-effectiveness ratio of the transition from the standard to the CHWs-led treatment amounted to 98.01 USD per additional SAM case recovered.

Conclusions

In the district of Mayahi in Niger, the CHWs-led SAM treatment was found to be cost-effective when compared to the standard protocol and provided additional advantages such as the reduction of costs for households.

Trial registration : ISRCTN with ID 31143316. https://doi.org/10.1186/ISRCTN31143316

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Introduction

Acute malnutrition is one of the major public health issues in the Sahel region. According to the World Health Organization (WHO), 38.4 million children under 5 years of age were affected by global acute malnutrition (GAM) in 2020 and of those 8 million had severe acute malnutrition (SAM) [ 1 ]. Children affected by this condition are 11 times more likely to die compared to well-nourished children [ 2 , 3 ]. The Standardized Monitoring and Assessment of Relief and Transition (SMART) survey conducted in Niger in 2022 showed a GAM prevalence of 13.6% (95% CI 11.2–16.4) in the Maradi region of which 3.9% (95% CI 2.5–6.1) SAM and 9.7% (95% CI 7.6–12.3) moderate acute malnutrition (MAM) [ 4 ]. These figures mean that 457 200 children aged 6–59 months suffered from SAM in 2021 [ 5 ].

According to the Community management of acute malnutrition (CMAM) protocol, children suffering from uncomplicated SAM are treated at health centers (HCs), where they receive outpatient treatment with ready-to-use therapeutic food (RUTF) and systemic treatment with amoxicillin (50–100 mg/kg/day twice a day for 5 days) and one single dose of 500 mg of mebendazole at the first visit for deworming. In addition, they receive RUTF every visit throughout the next 6–8 consecutive weeks of follow-up. The Simplified Lot Quality Assurance Sampling Evaluation of Access and Coverage (SLEAC) survey conducted in 2016 showed a treatment coverage of 41.5% in the Maradi region. This assessment outlined several geographical barriers, especially during the hunger gap, when families deplete their food reserves and new crops have not yet been harvested. The challenges include the significant time caregivers spend traveling to or waiting at HCs, misunderstandings about malnutrition, and a lack of funds for transportation. These factors are identified as the primary obstacles contributing to low access to health services [ 6 ]. To address this issue, between 2018 and 2019, a research study was conducted to assess the effectiveness and treatment coverage by incorporating community health workers (CHWs) into health posts (HPs) in addition to the standard SAM treatment provided solely at HCs. The control group received outpatient treatment for uncomplicated SAM by nurses at HCs, while the intervention group received outpatient treatment for uncomplicated SAM by nurses at HCs or by CHWs at HPs. The primary treatment outcome was recovery defined as the absence of bilateral pitting edema (fluid build-up in feet, legs, hands and arms) for 14 days and weight-for-height z -score (WHZ) ≥ −2 and/or mid upper arm circumference (MUAC) ≥ 125 mm, during two consecutive follow-up visits. The results showed a statistically significant difference in recovery rates with 77.2% children recovered in the intervention group (73.1% at HCs and 83.7% at HPs) vs. 72.1% in the control group ( p < 0.001); and a treatment coverage of 61.2% in the intervention group compared to 43.6% in the standard treatment group [ 7 ]. The CHWs-led treatment approach, part of the simplified approaches supported by UNICEF [ 8 ], has also shown its effectiveness and positive impact on coverage in other contexts such as Mali, Mauritania and Tanzania [ 9 , 10 , 11 ].

To plan and implement at scale, policymakers need stronger evidence to support the promising cost-effectiveness of using CHWs in child health-related settings, such as in the case of SAM treatment [ 12 ]. Bringing healthcare delivery closer to families through CHWs directly reduces the time and cost of every medical visit for the household and it is expected that it will also cause children to begin to be treated in better conditions, increasing the probability of recovery and/or reducing the duration of treatment. A study in Mali showed a recovery rate of 94.2% in the intervention group vs. 88.2% in the standard protocol highlighting that the cost per child recovered from SAM with the CHWs-led approach was 259 USD vs. 501 USD of the standard HCs-based treatment protocol (2016 USD). Each week of treatment, households under the CHWs-led approach spent half of the time receiving treatment and three times less money compared to those receiving treatment solely at the health center [ 13 ]. In Pakistan, the centralization of acute malnutrition treatment with lady health workers (CHWs in the country) did not show evidence of being a cost-effective intervention. The recovery rate was 76.0% and 83.0% in the intervention and control group, respectively and the cost per child recovered by implementing lady health workers was similar to cost at HCs (382 vs. 363, in 2016 USD). However, the cost for households receiving SAM treatment at HCs was double than the cost of care provided by lady health workers [ 14 ]. This wide variation in results suggests that cost-effectiveness may be influenced not only by the service delivery model of treating acute malnutrition in the community, but also by other factors such as the burden of acute malnutrition and the expected number of children suffering from the disease; and the quality of care and number of children recovered due to treatment delivered by these CHWs [ 15 ]. According to the Global Action Plan against Child Wasting, it is crucial to further analyze the cost-effectiveness of interventions to increase treatment coverage and achieve a reduction of the prevalence of wasting to less than 5% by 2025 [ 16 ].

The present study aims to analyze the costs and cost-effectiveness of SAM treatment delivered by CHWs compared to the standard protocol from a societal perspective in the Mayahi district of the Maradi region in Niger. This economic evaluation will be conducted on a within-trial time horizon for both cost and effectiveness results, and following the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines [ 17 ] (see Additional file 1 ).

Methodology

Description of the context and intervention.

A non-randomized controlled trial was conducted from June 2018 to March 2019 in the health district of Mayahi, of the region of Maradi in Niger. It included two rural communes, Maireyrey (the control area) and Guidan Amoumoune (the intervention area). According to the 2012 population census [ 18 ], Maireyrey and Guidan Amoumoune had, respectively, 64 183 and 88 199 inhabitants. Figure 1 shows a map of the two study areas with the location of the HCs and HPs. Socio-demographic characteristics in both areas were similar, for example family sample size, proportion of women, source of water in the household, HCs as the first option for caring children, among others. The intervention group appeared to have houses with better roofing and reported distance to HCs as the main barrier to health access [ 7 ].

Sanitary map of the two study areas

Prior to the start of the study, treatment of acute malnutrition was carried out by nurses at HCs, decentralized treatment at HPs with CHWs not being allowed by the administrators of the country’s SAM policy. All children 6–59 months who attended HCs or HPs and met the inclusion criteria were recruited in the study. The inclusion criteria were the presence of mild (+) or moderate (++) edema and/or a WHZ less than − 3 and/or a MUAC less than 115 mm [ 19 ]. Cases with severe edema, medical complications, or failed appetite tests were excluded from the study and referred for inpatient treatment. Outpatient treatment for uncomplicated SAM was provided for a maximum of 8 weeks (initial visit plus seven follow-up weekly visits) by nurses at the 4 existing HCs in the control group (standard treatment), and by nurses at the 6 existing HCs and 10 additional CHWs located at HPs in the intervention group (CHWs-led treatment). At the end of the treatment, the final nutritional recovery status of the children is assessed. The Ministry of Health provided treatment, UNICEF supplied RUTF while Action against Hunger (AAH) supervised activities.

Data collection

Treatment outcome data were obtained from the primary study [ 7 ]. Field data collection for the economic component was conducted between June 2019 in Niamey and August 2019 in Mayahi. Data on cost and resource usage were collected from (1) nurses providing SAM treatment at HCs; (2) CHWs at HPs; (3) AAH staff and partners involved in support, supervision, management and logistics; (4) caregivers of SAM children.

Financial and accounting costs of AAH Niger and study financial records were used as primary data sources. HCs staff, CHWs and project key informants including AAH staff and relevant partners were selected through deliberate sampling and interviewed using semi-structured interviews to map activities and to allocate the time for their implementation.

A total of 18 semi-structured interviews were carried out which included five CHWs, five nurses responsible for the HCs, one regional nutrition focal point, one Chief District Medical Officer, one financial District Officer, one doctor from the Ministry of Health responsible for inpatient treatment of SAM, and four AAH staff comprising a supervisor and the heads of the finance, logistics and human resources (HR) departments in Niamey and Maradi. These interviews allowed us to identify the resources used for the treatment of SAM at the HCs and HPs including but not limited to RUTF, drugs, medical equipment and consumables. Moreover, 16 focus group discussions were conducted: seven with community volunteers and nine involving children’s caregivers, who were enabled to gather data on the costs incurred by households for seeking care, and on the associated opportunity costs resulting from loss of income.

The tasks and activities linked to the provision of treatment such as consultations, training, and supervision of CHWs were mapped out and the corresponding time allocation for each activity was collected. Costs were calculated triangulating both accounting records and information obtained through key informant interviews.

Data analysis

The cost analysis is conducted using a combination of activity-based costing and a bottom-up approach, in line with the classification proposed by Njuguna et al. [ 20 ] on a within-trial time horizon. Besides, a societal perspective is employed to assess the impact of incorporating CHWs on household costs. Consequently, since opportunity costs associated with family income losses are included, our analysis considers economic and not just financial costs [ 21 ].

The allocation of fixed costs to activities is determined using activity-based costing, and the specific details are provided in Table 1 . Fixed costs include the costs independent of the number of children admitted for treatment and comprise activities grouped in the following categories: Supervision, Staff support and HPs implementation. In addition, HPs implementation category includes the following subcategories: Management and coordination, Training, HPs procurement and RUTF logistics. On the one hand, Supervision and Staff support categories’ costs are common to the entire program, and they must be distributed between control and intervention groups according to the population size of the areas. An exception was considered in the Monthly monitoring activity of the Supervision category as the number of supervisors involved differed. In specific, the control group had one supervisor while the intervention group had two, resulting in a double cost for the intervention group in this activity. On the other hand, all costs in the HPs implementation category are allocated entirely to the intervention group.

The bottom-up approach is used to compute variable costs, which are those dependent on the number of children admitted for treatment and/or the number of medical visits attended. Variable costs include the following categories: Transport, Opportunity costs, RUTF procurement, Healthcare delivery HR and Hospital referral. In each of these categories, the unit cost is multiplied by the number of medical visits attended, except for the Hospital referral category. In this case, the unit cost (which includes transport, care during inpatient treatment and opportunity cost for families) is multiplied by the number of children admitted for treatment but later transferred to the hospital due to medical complications developed during the follow-up. To determine the total cost of transport, opportunity and healthcare delivery HR for each group, the initial and final visits are added to the follow-up visits per each child. RUTF procurement total costs were calculated considering the initial and follow-up visits but excluding the final visit. Table 1 also outlines which parties are responsible for the costs associated with each activity and/or category.

Research costs related to investigator salaries and study registration are not included. All costs are reported in CFA Francs and converted to US Dollars using the January 2019 exchange rate (1 US Dollar = 575 CFA Francs). Since all costs were measured within a 1-year period, no discounting or inflation adjustments are applied, and it is assumed that no capitalization has occurred.

• Cost-effectiveness

To carry out the cost-effectiveness analysis of our data, the decision analysis network (DAN) presented in Figure 2 was developed in OpenMarkov (version 0.4.0), an open-source software package for probabilistic graphical models (PGMs), developed by the Research Centre for Intelligent Decision-Support Systems (CISIAD) at the Universidad Nacional de Educación a Distancia (UNED) in Madrid, Spain [ 22 , 23 , 24 ]. OpenMarkov has recently been applied in several medical cost-effectiveness analyses [ 25 , 26 , 27 ]. More specific details are given in Additional file 2 .

Decision analysis network

Based on this DAN, two approaches were considered. In the first approach, the measure of effectiveness was the recovery rate and the cost was measured per child admitted for treatment, as in the works of Rogers et al. [ 13 , 14 ]. Note that both cost and effectiveness measures are normalized to a per-patient basis. In the second approach, the measures of effectiveness and cost were, respectively, the number of children recovered and the total cost, as in the works of Johns et al. [ 28 ] and Wilunda et al. [ 11 ]. An advantage of this approach is that it considers the increased coverage attained when the treatment is delivered by CHWs at HPs, thus effectively addressing barriers to accessing health care. To ensure the fairness of the comparison, the total cost and the number of children recovered from the intervention area were rescaled to the population size of the control area, as was done previously by Zeng et al. [ 29 , 30 ]. To compare the control and intervention treatments in terms of cost-effectiveness, the average cost-effectiveness ratio (ACER) of each treatment and the incremental cost-effectiveness ratio (ICER) were calculated [ 31 ].

Sensitivity analysis

A multivariate probabilistic sensitivity analysis based on 1000 Monte Carlo simulations was performed under each approach to assess how changes in the input data affected the base case results. Dirichlet distributions were used for probabilities (three yellow nodes in Fig.  2 ), assuming standard deviations less than 0.1. Triangular symmetric distributions were used for those costs that were independent of the number of follow-up visits (Cost:Supervision, Cost:Staff_support, Cost:HPs_implementation and Cost:Hospital nodes), with the interval endpoints set at 10% from the mode. In contrast, normal distributions were used for those variable costs that were dependent on the number of follow-up visits (Cost:Transport, Cost:Opportunity, Cost:RUTF and Cost:Health_delivery_HR nodes), with standard deviations equal to 10% of the corresponding means. Illustrative examples of how uncertainty was introduced into the DAN presented in Fig.  2 , depending on the nature of each node, are given in Additional file 3 .

Table 1 presents the input costs for the base case, along with the relative percentage of each cost category and subcategory by group.

The transport cost per visit was 3.48 USD (2 h round trip on average) in the control group while in the intervention group it varied from 1.74 USD (1 hour round trip on average) for children treated at HCs to 1.30 USD (45-min round trip on average) for children treated at HPs. The opportunity cost per visit for children treated at HCs was 0.65 USD in both the control group and the intervention group, while for children treated at HPs this opportunity cost was reported by focus group participants to be null. The cost of the healthcare delivery HR was 0.65 USD per visit for children treated by nurses at HCs and only 0.18 USD for children treated by CHWs at HPs. To obtain these values, we have taken into account that visits lasted on average 20 min and that the monthly salaries of nurses and CHWs were, respectively, 313.04 USD and 86.96 USD. The RUTF procurement cost was 4.96 USD per visit across all groups. The unit cost per child transferred to the hospital is 131.95 USD in both groups. In the control group, 14 children were transferred, while in the intervention group, 27 children were transferred, with 20 treated at HCs and 7 at HPs.

The group frequencies and percentages of the follow-up visits are presented in Table 2 . Note that children with 0 follow-up visits are those who were admitted for treatment in the initial visit but did not attend any follow-up visits for some reason.

Table 3 presents the base case cost-effectiveness results. According to the first approach, the recovery rate was 72.1% in the control group and 77.2% in the intervention group [ 7 ]. The average cost per child admitted for treatment was 84.01 USD in the control group and 82.81 USD in the intervention group. These results showed that the CHWs-led treatment dominates the standard treatment, since it provided better outcomes according to both indicators. However, according to the second approach, the CHWs-led treatment was not only more effective than the standard treatment but also more expensive. The ACER, calculated following either approach, was 116.52 USD per child recovered in the control group and 107.22 USD in the intervention group.

As part of the second approach, the ICER was calculated at 98.01 USD, implying that having one additional child recovered in the rescaled intervention group required an additional cost of 98.01 USD compared to the control group. The rescaling factor was 0.7277 (64,183/88,199) while the ICER value of 98.01 USD was obtained from the results collected in Table 3 :

where \(\mathrm{119,141.38}=0.7277\times \mathrm{163,721.71}\) and \(\mathrm{1,111.21}=0.7277\times 1527.\) This result signifies that, compared to the control group, approximately 558 more children recovered in the rescaled intervention group at an additional cost of 54,708.33 USD.

Figure 3 shows the results of the multivariate probabilistic sensitivity analysis carried out under each approach. In the cost-effectiveness plane, each pair of blue and red points represents the cost and the effectiveness corresponding to the control group (in blue) and the intervention group (in red) of one Monte Carlo simulation. This cost-effectiveness plane provides a clear image of the uncertainty introduced in the input data. Greater concentration of points indicates reduced uncertainty, whereas increased scattering of points indicates greater uncertainty. The cost-effectiveness plane allows the calculation of the percentage of simulations where one treatment is cost-effective compared to the other based on a specific willingness to pay (WTP) value. Interestingly, under the first approach, the probability of being cost-effective is always higher for the intervention group than the control group, independently of the WTP value. However, this changes under the second approach, where (1) for a WTP value smaller than 98.01 USD, which coincides with the ICER of the base case, the standard treatment has more probability of being cost-effective than the CHWs-led treatment; (2) for values above 98.01 USD the probability increases for the CHWs-led treatment; and (3) when the WTP value was 98.01 USD, both treatments have the same probability of being cost-effective.

Sensitivity analysis graphs

This analysis showed that CHWs-led treatment in Niger is a cost-effective intervention, compared to the standard protocol delivered solely at HCs, which is consistent with the findings from previous studies in other contexts. In terms of costs, RUTF procurement was the category with the highest cost, representing 34.7% of the total cost in the control group and 31.7% in the intervention group. This proportion was similar to the one obtained in Malawi [ 32 ], lower than in Tanzania [ 11 ], higher than Pakistan, where cost related to RUTF represents 15.2% in the control and 15.7% in the intervention group [ 14 ], and much higher than Mali, where the cost is 6.0% and 11.8% in the control and intervention group, respectively [ 13 ]. Transport was the second highest cost category for the control group reaching 28.5% but represented only 11.9% of the total cost for the intervention group. This difference can be explained by three main factors. First, the location of HPs and therefore the reduced distance to health services in the intervention area compared to the control area. Second, the fixed costs being much higher in the intervention group (47.6%) compared to the control group (23.3%) due to the implementation of the HPs, and consequently, the variable costs categories, such as Transport, having less relative relevance for the intervention group than for the control group. Third, as presented in Table 2 , children in the control group required more follow-up visits to reach recovery than those in the intervention group (4.88 vs. 4.30 on average). In specific, the study found a higher number of children in the control group who needed to attend at least 6 follow-up visits to be discharged as recovered. The most plausible explanation for the difference in the number of visits among groups is that children from the control group accessed treatment later and in a worse clinical condition [ 7 ]. This finding supports the hypothesis that CHWs facilitate early identification and treatment of children leading to a shorter average length of stay and, consequently, reducing the variable costs, including the transport cost [ 33 ]. Regarding the costs of the healthcare delivery HR, they constitute less than 6% of total costs in both groups. However, these costs represent a lower percentage in the intervention group (3.6%) than in the control group (5.3%).

The costs were distributed among the different payers as follows: 11.9% by the Ministry of Health, 53.8% by NGOs and 34.3% by the households in the control group; 7.7% by the Ministry of Health, 77.0% by NGOs and 15.3% by the households in the intervention group. NGOs incurred the highest cost in both groups while communities incurred the lowest costs, which aligns with the findings of other studies conducted previously [ 13 , 14 ]. The cost to implement the intervention increased the NGOs’ cost percentage in the intervention group compared to the control group.

In our study, the costs per child admitted to treatment (82.81 USD) and recovered (107.22 USD) in the intervention group are among the lowest reported in programs where CHWs support the treatment of SAM in Africa. For example, these costs were 166.31 USD and 179.40 USD in Ethiopia [ 34 ], 146.50 USD and 161.77 USD in Tanzania [ 11 ] and 259.91 USD and 275.89 USD in Mali [ 13 ]. This lower cost in our study could be influenced by the higher number of children admitted in Niger, which is 1,977, with fixed costs being shared. In the three other studies, less than 400 children under five were admitted in the intervention group. However, although we have expressed all these costs in 2019 US dollars, comparing CMAM programs can be challenging due to the differences in methodologies, timelines, ways of implementation and data collection.

In Niger, the treatment of acute malnutrition is free of charge for communities. However, during the treatment community members incur expenses linked to transport costs to reach health services and the corresponding opportunity costs associated with seeking treatment. Our study showed that a CHWs-led treatment decreased these expenses. The cost per child admitted for treatment in the control group amounted to 28.74 USD for the households, whereas in the intervention group it was 12.62 USD, less than half of the control group's cost. This difference slightly increases when comparing the cost for the households per child recovered (39.86 USD in the control group vs 16.34 USD in the intervention group). Regarding the cost per visit, in the control group the households that received treatment at HCs spent an average of 4.13 USD. In contrast, within the intervention group, households spent 2.39 USD per visit at HCs and 1.30 USD at HPs. These differences may be explained by the greater proximity to health services in the intervention area, which is one of the main arguments in favor of the CHWs-led treatment approach. Similar findings were presented in Mali [ 13 ], where households whose children received treatment from CHWs spent on average three times less money. In the case of Pakistan, the treatment with the lady health workers did not lead to cost savings for households [ 14 ]. This significant reduction in cost reported in our study could enable not only an increase in provision and access to health services, but also, from a societal perspective, cost savings that could free resources for other purposes, and time savings from reduced treatment, meaning that caregivers and patients can use the time for other activities.

Our findings indicate that SAM treatment delivered by CHWs is a cost-effective intervention compared to the standard treatment, with an additional cost of 98.01 USD per each additional child recovered. Implementing this program over a longer period of time could enhance its cost-effectiveness since some of the fixed costs would be diluted over time. For example, if the program had been continued long enough for the number of children admitted to double, and assuming that fixed costs had not increased, the projected cost per child admitted for treatment in the intervention (control) group would be 63.11 USD (74.23 USD), and the projected cost per child recovered would be 81.71 USD (102.96 USD). In addition, the projected ICER under the second approach would be 60.66 USD, which is 38% less than the ICER calculated in the base case. In the same way, if the program had been continued long enough for the number of children admitted to quintuple, the projected ICER would be 38.26 USD, 61% less than in the base case.

According to our first approach, in contrast with the findings reported by Rogers et al. in the Sindh Province of Pakistan [ 14 ], our intervention group had better outcomes in terms of both recovery rates and cost per child admitted for treatment compared to the control group, which was also reflected by the smaller ACER in the intervention group.

The second approach proved particularly relevant in scenarios where the new intervention effectively tackles barriers of access to healthcare, enabling a greater number of children to be admitted for treatment at earlier stages of severity, resulting in shorter recovery times and reduction in variable costs. According to this second approach, rescaling the measures of effectiveness and cost, namely the total number of children recovered and total cost incurred, based on the population sizes, ensured a fairer comparison and should be considered in similar cost-effectiveness studies. However, this aspect has been at times overlooked in existing literature.

The second approach also provided an additional advantage over the first approach by conveying a clear message, particularly valuable for policymakers and donors, regarding the additional cost necessary to achieve the recovery of an additional child through the CHWs-led treatment compared to the standard treatment. This approach considered the increased number of children admitted for treatment as well as the higher recovery rate in the CHWs-led treatment while the first approach only took into account the recovery rate, independently of the number of children admitted for treatment.

This research presents several strengths. Concerning costs, the most important is the use of a societal perspective, which incorporates household costs, emphasizing the cost savings for families resulting from the inclusion of CHWs. Besides, the combination of activity-based costing and a bottom-up approach has allowed us to calculate variable costs according to the number of children admitted for treatment and the number of follow-up visits made. Regarding the cost-effectiveness analysis, the use of two different methodological approaches has made it possible for our study to be comparable across a wider group of studies and to yield significant results that would remain hidden if only the first approach had been used.

The study also presents two important limitations. First, the data come from a non-randomized control trial, which does not allow us to assume comparability between the two groups. In addition, the potential impact of the difference in the population size between the groups has been minimized by rescaling the data to calculate the ICER. Second, some costs such as RUTF, transportation costs, community volunteer salaries and material for medical appointments were considered for HPs but not for HCs in both control and intervention groups. The absence of these costs, for which data were not available, may have slightly biased the results in favor of the control group.

Considering the substantial number of children affected by acute malnutrition every year, and the geographical, economic and social barriers to health service delivery, new approaches are necessary to increase treatment coverage. Given the limited availability of resources, it is crucial for the Niger Ministry of Health and international stakeholders to prioritize their interventions. The present study aligns with the available evidence regarding the effectiveness of the CHWs-led treatment as one of the proposed simplified approaches also showing its ability to reduce expenses for families. Policymakers can consider these results when making decisions about the implementation of this new approach to tackle the impact of acute malnutrition.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

World Health Organization, United Nations Children’s Fund (UNICEF), World Bank. Levels and trends in child malnutrition: UNICEF/WHO/The World Bank Group joint child malnutrition estimates: key findings of the 2021 edition [Internet]. World Health Organization; 2021 [cited 2024 Jan 27]. Available from: https://iris.who.int/handle/10665/341135

Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, et al. Maternal and child undernutrition and overweight in low-income and middle-income countries. The Lancet. 2013;382:427–51.

Article   Google Scholar  

Olofin I, McDonald CM, Ezzati M, Flaxman S, Black RE, Fawzi WW, et al. Associations of suboptimal growth with all-cause and cause-specific mortality in children under five years: a pooled analysis of ten prospective studies. PLoS ONE. 2013;8: e64636.

Article   CAS   PubMed   PubMed Central   Google Scholar  

SMART. Enquête nutritionnelle et de mortalité retrospective au Niger [Internet]. 2022. Available from: https://www.stat-niger.org/wp-content/uploads/nutrition/RAPPORT_SMART_NUTRITION_Niger_2022_INS.pdf

United Nations Office for the Coordination of Humanitarian Affairs. Niger [Internet]. OCHA. 2022 [cited 2024 Jan 27]. Available from: https://www.unocha.org/niger

Simplified Lot Quality Assurance Sampling Evaluation of Access and Coverage survey [Internet]. 2022. Available from: https://acutemalnutrition.org/en/coverage

Ogobara Dougnon A, Charle-Cuéllar P, Toure F, Aziz Gado A, Sanoussi A, Lazoumar RH, et al. Impact of integration of severe acute malnutrition treatment in primary health care provided by community health workers in rural Niger. Nutrients. 2021;13:4067.

Article   PubMed   PubMed Central   Google Scholar  

UNICEF. Simplified Approaches [Internet]. 2020. Available from: https://www.simplifiedapproaches.org/es/what-are-simplified-approaches

Alvarez Morán JL, Alé GBF, Charle P, Sessions N, Doumbia S, Guerrero S. The effectiveness of treatment for Severe Acute Malnutrition (SAM) delivered by community health workers compared to a traditional facility based model. BMC Health Serv Res. 2018;18:207.

Charle-Cuéllar P, Lopez-Ejeda N, Toukou Souleymane H, Yacouba D, Diagana M, Dougnon AO, et al. Effectiveness and coverage of treatment for severe acute malnutrition delivered by community health workers in the Guidimakha Region. Mauritania Children. 2021;8:1132.

Article   PubMed   Google Scholar  

Wilunda C, Mumba FG, Putoto G, Maya G, Musa E, Lorusso V, et al. Effectiveness of screening and treatment of children with severe acute malnutrition by community health workers in Simiyu region, Tanzania: a quasi-experimental pilot study. Sci Rep. 2021;11:2342.

Vaughan K, Kok MC, Witter S, Dieleman M. Costs and cost-effectiveness of community health workers: evidence from a literature review. Hum Resour Health. 2015;13:71.

Rogers E, Martínez K, Morán JLA, Alé FGB, Charle P, Guerrero S, et al. Cost-effectiveness of the treatment of uncomplicated severe acute malnutrition by community health workers compared to treatment provided at an outpatient facility in rural Mali. Hum Resour Health. 2018;16:12.

Rogers E, Guerrero S, Kumar D, Soofi S, Fazal S, Martínez K, et al. Evaluation of the cost-effectiveness of the treatment of uncomplicated severe acute malnutrition by lady health workers as compared to an outpatient therapeutic feeding programme in Sindh Province, Pakistan. BMC Public Health. 2019;19:84.

Action against Hunger, Save the Children. The Cost-efficiency and Cost-effectiveness of the Management of Wasting in Children: A review of the evidence, approaches, and lessons [Internet]. Save Child. Resour. Cent. 2020 [cited 2024 Jan 27]. Available from: https://resourcecentre.savethechildren.net/document/cost-efficiency-and-cost-effectiveness-management-wasting-children-review-evidence/

World Health Organization. Global action plan on child wasting: a framework for action to accelerate progress in preventing and managing child wasting and the achievement of the Sustainable Development Goals [Internet]. 2020. Available from: https://www.who.int/publications/m/item/global-action-plan-on-child-wasting-a-framework-for-action

Husereau D, Drummond M, Augustovski F, De Bekker-Grob E, Briggs AH, Carswell C, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: a report of the ISPOR CHEERS II Good Practices Task Force. Value Health. 2022;25:10–31.

Brinkhoff T. City Population [Internet]. [cited 2024 Jan 27]. Available from: https://www.citypopulation.de/en/niger/admin/

World Health Organization. WHO Child Growth Standards—Length/Height-for-age, Weight-for-age, Weight-for-length, Weight-for-height and Body Mass Index-for age: Methods and Development [Internet]. Geneva: World Health Organization; 2006. Available from: https://www.who.int/publications-detail-redirect/924154693X

Njuguna RG, Berkley JA, Jemutai J. Cost and cost-effectiveness analysis of treatment for child undernutrition in low- and middle-income countries: a systematic review. Wellcome Open Res. 2020;5:62.

Turner HC, Sandmann FG, Downey LE, Orangi S, Teerawattananon Y, Vassall A, et al. What are economic costs and when should they be used in health economic studies? Cost Eff Resour Alloc. 2023;21:31.

Arias M, Pérez-Martín J, Luque M, Díez FJ. OpenMarkov, an Open-Source Tool for Probabilistic Graphical Models. Proc Twenty-Eighth Int Jt Conf Artif Intell [Internet]. Macao, China: International Joint Conferences on Artificial Intelligence Organization; 2019 [cited 2024 Jan 27]. p. 6485–7. Available from: https://www.ijcai.org/proceedings/2019/931

Díez FJ, Luque M, Bermejo I. Decision analysis networks. Int J Approx Reason. 2018;96:1–17.

Díez FJ, Luque M, Arias M, Pérez-Martín J. Cost-effectiveness analysis with unordered decisions. Artif Intell Med. 2021;117: 102064.

Pérez-Martín J, Artaso MA, Díez FJ. Cost-effectiveness of pediatric bilateral cochlear implantation in Spain: cost-effectiveness of pediatric BCI in Spain. Laryngoscope. 2017;127:2866–72.

Faccioli N, Santi E, Foti G, Mansueto G, Corain M. Cost-effectiveness of introducing cone-beam computed tomography (CBCT) in the management of complex phalangeal fractures: economic simulation. Musculoskelet Surg. 2022;106:169–77.

Article   CAS   PubMed   Google Scholar  

Faccioli N, Santi E, Foti G, D’Onofrio M. Cost-effectiveness analysis of including contrast-enhanced ultrasound in management of pancreatic cystic neoplasms. Radiol Med (Torino). 2022;127:349–59.

Johns B, Probandari A, Mahendradhata Y, Ahmad RA. An analysis of the costs and treatment success of collaborative arrangements among public and private providers for tuberculosis control in Indonesia. Health Policy. 2009;93:214–24.

Zeng W, Pradhan E, Khanna M, Fadeyibi O, Fritsche G, Odutolu O. Cost-effectiveness analysis of the decentralized facility financing and performance-based financing program in Nigeria. J Hosp Manag Health Policy. 2022;6:13–13.

Zeng W, Shepard DS, Nguyen H, Chansa C, Das AK, Qamruddin J, et al. Cost-effectiveness of results-based financing, Zambia: a cluster randomized trial. Bull World Health Organ. 2018;96:760–71.

Hoch JS, Dewa CS. A clinician’s guide to correct cost-effectiveness analysis: think incremental not average. Can J Psychiatry. 2008;53:267–74.

Wilford R, Golden K, Walker DG. Cost-effectiveness of community-based management of acute malnutrition in Malawi. Health Policy Plan. 2012;27:127–37.

López-Ejeda N, Charle-Cuellar P, Alé F, Álvarez JL, Vargas A, Guerrero S. Bringing severe acute malnutrition treatment close to households through community health workers can lead to early admissions and improved discharge outcomes. PloS One. 2020;15: e0227939.

Tekeste A, Wondafrash M, Azene G, Deribe K. Cost effectiveness of community-based and in-patient therapeutic feeding programs to treat severe acute malnutrition in Ethiopia. Cost Eff Resour Alloc. 2012;10:4.

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Acknowledgements

The authors would like to thank all partners who contributed to this study, the Ministry of Health of Niger through the Directorate of Nutrition, Centre de Recherche Médicale et Sanitaire (CERMES) Niamey and all the organizations of the Technical Advisory Group. Our thanks to all the mothers of the children who participated in the study for their time, to the community health workers for their work, to the community leaders for their involvement, to the health staff of the Maradi regional public health directorate and the Mayahi health district for their support, to the entire Action Against Hunger team of Niger mission for their commitment with this intervention. A special mention must go to Dieynaba N'Diaye, who designed the study, conducted and supervised all the fieldwork. Finally, we would like to thank the two referees for their valuable comments that improved our manuscript.

All the actions in the field were supported by funds coming from the Office of U.S. foreign disaster assistance (OFDA/USAID) Award No. AID-OFDAG-17-00277, by the Government of Spain, Grant: PID2019-108679RBI00 13039/501100011033 and UNICEF for write up and publication.

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Elisa M. Molanes-López

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Contributions

JMF and EMM-L interpreted and analyzed data, wrote the manuscript; PC-C identified and contributed to the design of the study and advised on the manuscript writing; AOD validated the field data information of the study; AAG supervised data collection during the implementation; AS, NO and RHL revised the manuscript draft. All authors have read and agreed to the published version of the manuscript.

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Correspondence to Pilar Charle-Cuéllar .

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This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving research study participants were approved by The National Health Research Ethics Committee of Niger (007/201 8/CNERS).

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Supplementary Information

Additional file 1. .

CHEERS 2022 Checklist.

Additional file 2.

 Specific details of the DAN displayed in Figure 2 .

Additional file 3. 

Illustrative examples of how uncertainty was incorporated in the DAN displayed in Figure 2 . 

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Molanes-López, E.M., Ferrer, J.M., Dougnon, A.O. et al. Cost-effectiveness of severe acute malnutrition treatment delivered by community health workers in the district of Mayahi, Niger. Hum Resour Health 22 , 22 (2024). https://doi.org/10.1186/s12960-024-00904-1

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Baltimore bridge collapse: a bridge engineer explains what happened, and what needs to change

Associate Professor, Civil Engineering, Monash University

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Colin Caprani receives funding from the Department of Transport (Victoria) and the Level Crossing Removal Project. He is also Chair of the Confidential Reporting Scheme for Safer Structures - Australasia, Chair of the Australian Regional Group of the Institution of Structural Engineers, and Australian National Delegate for the International Association for Bridge and Structural Engineering.

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When the container ship MV Dali, 300 metres long and massing around 100,000 tonnes, lost power and slammed into one of the support piers of the Francis Scott Key Bridge in Baltimore, the bridge collapsed in moments . Six people are presumed dead, several others injured, and the city and region are expecting a months-long logistical nightmare in the absence of a crucial transport link.

It was a shocking event, not only for the public but for bridge engineers like me. We work very hard to ensure bridges are safe, and overall the probability of being injured or worse in a bridge collapse remains even lower than the chance of being struck by lightning.

However, the images from Baltimore are a reminder that safety can’t be taken for granted. We need to remain vigilant.

So why did this bridge collapse? And, just as importantly, how might we make other bridges more safe against such collapse?

A 20th century bridge meets a 21st century ship

The Francis Scott Key Bridge was built through the mid 1970s and opened in 1977. The main structure over the navigation channel is a “continuous truss bridge” in three sections or spans.

The bridge rests on four supports, two of which sit each side of the navigable waterway. It is these two piers that are critical to protect against ship impacts.

And indeed, there were two layers of protection: a so-called “dolphin” structure made from concrete, and a fender. The dolphins are in the water about 100 metres upstream and downstream of the piers. They are intended to be sacrificed in the event of a wayward ship, absorbing its energy and being deformed in the process but keeping the ship from hitting the bridge itself.

The fender is the last layer of protection. It is a structure made of timber and reinforced concrete placed around the main piers. Again, it is intended to absorb the energy of any impact.

Fenders are not intended to absorb impacts from very large vessels . And so when the MV Dali, weighing more than 100,000 tonnes, made it past the protective dolphins, it was simply far too massive for the fender to withstand.

Read more: I've captained ships into tight ports like Baltimore, and this is how captains like me work with harbor pilots to avoid deadly collisions

Video recordings show a cloud of dust appearing just before the bridge collapsed, which may well have been the fender disintegrating as it was crushed by the ship.

Once the massive ship had made it past both the dolphin and the fender, the pier – one of the bridge’s four main supports – was simply incapable of resisting the impact. Given the size of the vessel and its likely speed of around 8 knots (15 kilometres per hour), the impact force would have been around 20,000 tonnes .

Bridges are getting safer

This was not the first time a ship hit the Francis Scott Bridge. There was another collision in 1980 , damaging a fender badly enough that it had to be replaced.

Around the world, 35 major bridge collapses resulting in fatalities were caused by collisions between 1960 and 2015, according to a 2018 report from the World Association for Waterborne Transport Infrastructure. Collisions between ships and bridges in the 1970s and early 1980s led to a significant improvement in the design rules for protecting bridges from impact.

Further impacts in the 1970s and early 1980s instigated significant improvements in the design rules for impact.

The International Association for Bridge and Structural Engineering’s Ship Collision with Bridges guide, published in 1993, and the American Association of State Highway and Transporation Officials’ Guide Specification and Commentary for Vessel Collision Design of Highway Bridges (1991) changed how bridges were designed.

In Australia, the Australian Standard for Bridge Design (published in 2017) requires designers to think about the biggest vessel likely to come along in the next 100 years, and what would happen if it were heading for any bridge pier at full speed. Designers need to consider the result of both head-on collisions and side-on, glancing blows. As a result, many newer bridges protect their piers with entire human-made islands.

Of course, these improvements came too late to influence the design of the Francis Scott Key Bridge itself.

Lessons from disaster

So what are the lessons apparent at this early stage?

First, it’s clear the protection measures in place for this bridge were not enough to handle this ship impact. Today’s cargo ships are much bigger than those of the 1970s, and it seems likely the Francis Scott Key Bridge was not designed with a collision like this in mind.

So one lesson is that we need to consider how the vessels near our bridges are changing. This means we cannot just accept the structure as it was built, but ensure the protection measures around our bridges are evolving alongside the ships around them.

Second, and more generally, we must remain vigilant in managing our bridges. I’ve written previously about the current level of safety of Australian bridges, but also about how we can do better.

This tragic event only emphasises the need to spend more on maintaining our ageing infrastructure. This is the only way to ensure it remains safe and functional for the demands we put on it today.

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• container ships
• Baltimore bridge collapse

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