is literature review part of data collection

Data Management and Repositories for Literature Reviews

• First Online: 11 August 2022

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• Rob Dekkers 4 ,
• Lindsey Carey 5 &
• Peter Langhorne 6  

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The conduct of literature reviews and their outcomes are of interest to many as outlined in the previous chapter; therefore, they should be accessible. In this sense, particularly, systematic reviews have been leading the way. Nowadays, it is more common that data, results and outcomes of research, including literature reviews, are found in the public domain, besides publications in journals so that others can either review the materials of a study or reuse data of research. To this purpose, this chapter will look at data management, how data can be stored in repositories and how outcomes can be disseminated, particularly from the perspective of literature reviews.

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The processes are derived from the presentation about research data management by Dr Niels Cadée for the Workshop [Systematic] Literature Reviews on 26th May 2016 (University of Glasgow).

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Dekkers, R., Carey, L., Langhorne, P. (2022). Data Management and Repositories for Literature Reviews. In: Making Literature Reviews Work: A Multidisciplinary Guide to Systematic Approaches. Springer, Cham. https://doi.org/10.1007/978-3-030-90025-0_14

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Cochrane Training

Chapter 5: collecting data.

Tianjing Li, Julian PT Higgins, Jonathan J Deeks

Key Points:

• Systematic reviews have studies, rather than reports, as the unit of interest, and so multiple reports of the same study need to be identified and linked together before or after data extraction.
• Because of the increasing availability of data sources (e.g. trials registers, regulatory documents, clinical study reports), review authors should decide on which sources may contain the most useful information for the review, and have a plan to resolve discrepancies if information is inconsistent across sources.
• Review authors are encouraged to develop outlines of tables and figures that will appear in the review to facilitate the design of data collection forms. The key to successful data collection is to construct easy-to-use forms and collect sufficient and unambiguous data that faithfully represent the source in a structured and organized manner.
• Effort should be made to identify data needed for meta-analyses, which often need to be calculated or converted from data reported in diverse formats.
• Data should be collected and archived in a form that allows future access and data sharing.

Cite this chapter as: Li T, Higgins JPT, Deeks JJ (editors). Chapter 5: Collecting data. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook .

5.1 Introduction

Systematic reviews aim to identify all studies that are relevant to their research questions and to synthesize data about the design, risk of bias, and results of those studies. Consequently, the findings of a systematic review depend critically on decisions relating to which data from these studies are presented and analysed. Data collected for systematic reviews should be accurate, complete, and accessible for future updates of the review and for data sharing. Methods used for these decisions must be transparent; they should be chosen to minimize biases and human error. Here we describe approaches that should be used in systematic reviews for collecting data, including extraction of data directly from journal articles and other reports of studies.

5.2 Sources of data

Studies are reported in a range of sources which are detailed later. As discussed in Section 5.2.1 , it is important to link together multiple reports of the same study. The relative strengths and weaknesses of each type of source are discussed in Section 5.2.2 . For guidance on searching for and selecting reports of studies, refer to Chapter 4 .

Journal articles are the source of the majority of data included in systematic reviews. Note that a study can be reported in multiple journal articles, each focusing on some aspect of the study (e.g. design, main results, and other results).

Conference abstracts are commonly available. However, the information presented in conference abstracts is highly variable in reliability, accuracy, and level of detail (Li et al 2017).

Errata and letters can be important sources of information about studies, including critical weaknesses and retractions, and review authors should examine these if they are identified (see MECIR Box 5.2.a ).

Trials registers (e.g. ClinicalTrials.gov) catalogue trials that have been planned or started, and have become an important data source for identifying trials, for comparing published outcomes and results with those planned, and for obtaining efficacy and safety data that are not available elsewhere (Ross et al 2009, Jones et al 2015, Baudard et al 2017).

Clinical study reports (CSRs) contain unabridged and comprehensive descriptions of the clinical problem, design, conduct and results of clinical trials, following a structure and content guidance prescribed by the International Conference on Harmonisation (ICH 1995). To obtain marketing approval of drugs and biologics for a specific indication, pharmaceutical companies submit CSRs and other required materials to regulatory authorities. Because CSRs also incorporate tables and figures, with appendices containing the protocol, statistical analysis plan, sample case report forms, and patient data listings (including narratives of all serious adverse events), they can be thousands of pages in length. CSRs often contain more data about trial methods and results than any other single data source (Mayo-Wilson et al 2018). CSRs are often difficult to access, and are usually not publicly available. Review authors could request CSRs from the European Medicines Agency (Davis and Miller 2017). The US Food and Drug and Administration had historically avoided releasing CSRs but launched a pilot programme in 2018 whereby selected portions of CSRs for new drug applications were posted on the agency’s website. Many CSRs are obtained through unsealed litigation documents, repositories (e.g. clinicalstudydatarequest.com ), and other open data and data-sharing channels (e.g. The Yale University Open Data Access Project) (Doshi et al 2013, Wieland et al 2014, Mayo-Wilson et al 2018)).

Regulatory reviews such as those available from the US Food and Drug Administration or European Medicines Agency provide useful information about trials of drugs, biologics, and medical devices submitted by manufacturers for marketing approval (Turner 2013). These documents are summaries of CSRs and related documents, prepared by agency staff as part of the process of approving the products for marketing, after reanalysing the original trial data. Regulatory reviews often are available only for the first approved use of an intervention and not for later applications (although review authors may request those documents, which are usually brief). Using regulatory reviews from the US Food and Drug Administration as an example, drug approval packages are available on the agency’s website for drugs approved since 1997 (Turner 2013); for drugs approved before 1997, information must be requested through a freedom of information request. The drug approval packages contain various documents: approval letter(s), medical review(s), chemistry review(s), clinical pharmacology review(s), and statistical reviews(s).

Individual participant data (IPD) are usually sought directly from the researchers responsible for the study, or may be identified from open data repositories (e.g. www.clinicalstudydatarequest.com ). These data typically include variables that represent the characteristics of each participant, intervention (or exposure) group, prognostic factors, and measurements of outcomes (Stewart et al 2015). Access to IPD has the advantage of allowing review authors to reanalyse the data flexibly, in accordance with the preferred analysis methods outlined in the protocol, and can reduce the variation in analysis methods across studies included in the review. IPD reviews are addressed in detail in Chapter 26 .

MECIR Box 5.2.a Relevant expectations for conduct of intervention reviews

5.2.1 Studies (not reports) as the unit of interest

In a systematic review, studies rather than reports of studies are the principal unit of interest. Since a study may have been reported in several sources, a comprehensive search for studies for the review may identify many reports from a potentially relevant study (Mayo-Wilson et al 2017a, Mayo-Wilson et al 2018). Conversely, a report may describe more than one study.

Multiple reports of the same study should be linked together (see MECIR Box 5.2.b ). Some authors prefer to link reports before they collect data, and collect data from across the reports onto a single form. Other authors prefer to collect data from each report and then link together the collected data across reports. Either strategy may be appropriate, depending on the nature of the reports at hand. It may not be clear that two reports relate to the same study until data collection has commenced. Although sometimes there is a single report for each study, it should never be assumed that this is the case.

MECIR Box 5.2.b Relevant expectations for conduct of intervention reviews

It can be difficult to link multiple reports from the same study, and review authors may need to do some ‘detective work’. Multiple sources about the same trial may not reference each other, do not share common authors (Gøtzsche 1989, Tramèr et al 1997), or report discrepant information about the study design, characteristics, outcomes, and results (von Elm et al 2004, Mayo-Wilson et al 2017a).

Some of the most useful criteria for linking reports are:

• trial registration numbers;
• authors’ names;
• sponsor for the study and sponsor identifiers (e.g. grant or contract numbers);
• location and setting (particularly if institutions, such as hospitals, are named);
• specific details of the interventions (e.g. dose, frequency);
• numbers of participants and baseline data; and
• date and duration of the study (which also can clarify whether different sample sizes are due to different periods of recruitment), length of follow-up, or subgroups selected to address secondary goals.

Review authors should use as many trial characteristics as possible to link multiple reports. When uncertainties remain after considering these and other factors, it may be necessary to correspond with the study authors or sponsors for confirmation.

5.2.2 Determining which sources might be most useful

A comprehensive search to identify all eligible studies from all possible sources is resource-intensive but necessary for a high-quality systematic review (see Chapter 4 ). Because some data sources are more useful than others (Mayo-Wilson et al 2018), review authors should consider which data sources may be available and which may contain the most useful information for the review. These considerations should be described in the protocol. Table 5.2.a summarizes the strengths and limitations of different data sources (Mayo-Wilson et al 2018). Gaining access to CSRs and IPD often takes a long time. Review authors should begin searching repositories and contact trial investigators and sponsors as early as possible to negotiate data usage agreements (Mayo-Wilson et al 2015, Mayo-Wilson et al 2018).

Table 5.2.a Strengths and limitations of different data sources for systematic reviews

5.2.3 Correspondence with investigators

Review authors often find that they are unable to obtain all the information they seek from available reports about the details of the study design, the full range of outcomes measured and the numerical results. In such circumstances, authors are strongly encouraged to contact the original investigators (see MECIR Box 5.2.c ). Contact details of study authors, when not available from the study reports, often can be obtained from more recent publications, from university or institutional staff listings, from membership directories of professional societies, or by a general search of the web. If the contact author named in the study report cannot be contacted or does not respond, it is worthwhile attempting to contact other authors.

Review authors should consider the nature of the information they require and make their request accordingly. For descriptive information about the conduct of the trial, it may be most appropriate to ask open-ended questions (e.g. how was the allocation process conducted, or how were missing data handled?). If specific numerical data are required, it may be more helpful to request them specifically, possibly providing a short data collection form (either uncompleted or partially completed). If IPD are required, they should be specifically requested (see also Chapter 26 ). In some cases, study investigators may find it more convenient to provide IPD rather than conduct additional analyses to obtain the specific statistics requested.

MECIR Box 5.2.c Relevant expectations for conduct of intervention reviews

5.3 What data to collect

5.3.1 what are data.

For the purposes of this chapter, we define ‘data’ to be any information about (or derived from) a study, including details of methods, participants, setting, context, interventions, outcomes, results, publications, and investigators. Review authors should plan in advance what data will be required for their systematic review, and develop a strategy for obtaining them (see MECIR Box 5.3.a ). The involvement of consumers and other stakeholders can be helpful in ensuring that the categories of data collected are sufficiently aligned with the needs of review users ( Chapter 1, Section 1.3 ). The data to be sought should be described in the protocol, with consideration wherever possible of the issues raised in the rest of this chapter.

The data collected for a review should adequately describe the included studies, support the construction of tables and figures, facilitate the risk of bias assessment, and enable syntheses and meta-analyses. Review authors should familiarize themselves with reporting guidelines for systematic reviews (see online Chapter III and the PRISMA statement; (Liberati et al 2009) to ensure that relevant elements and sections are incorporated. The following sections review the types of information that should be sought, and these are summarized in Table 5.3.a (Li et al 2015).

MECIR Box 5.3.a Relevant expectations for conduct of intervention reviews

Table 5.3.a Checklist of items to consider in data collection

*Full description required for assessments of risk of bias (see Chapter 8 , Chapter 23 and Chapter 25 ).

5.3.2 Study methods and potential sources of bias

Different research methods can influence study outcomes by introducing different biases into results. Important study design characteristics should be collected to allow the selection of appropriate methods for assessment and analysis, and to enable description of the design of each included study in a table of ‘Characteristics of included studies’, including whether the study is randomized, whether the study has a cluster or crossover design, and the duration of the study. If the review includes non-randomized studies, appropriate features of the studies should be described (see Chapter 24 ).

Detailed information should be collected to facilitate assessment of the risk of bias in each included study. Risk-of-bias assessment should be conducted using the tool most appropriate for the design of each study, and the information required to complete the assessment will depend on the tool. Randomized studies should be assessed using the tool described in Chapter 8 . The tool covers bias arising from the randomization process, due to deviations from intended interventions, due to missing outcome data, in measurement of the outcome, and in selection of the reported result. For each item in the tool, a description of what happened in the study is required, which may include verbatim quotes from study reports. Information for assessment of bias due to missing outcome data and selection of the reported result may be most conveniently collected alongside information on outcomes and results. Chapter 7 (Section 7.3.1) discusses some issues in the collection of information for assessments of risk of bias. For non-randomized studies, the most appropriate tool is described in Chapter 25 . A separate tool also covers bias due to missing results in meta-analysis (see Chapter 13 ).

A particularly important piece of information is the funding source of the study and potential conflicts of interest of the study authors.

Some review authors will wish to collect additional information on study characteristics that bear on the quality of the study’s conduct but that may not lead directly to risk of bias, such as whether ethical approval was obtained and whether a sample size calculation was performed a priori.

5.3.3 Participants and setting

Details of participants are collected to enable an understanding of the comparability of, and differences between, the participants within and between included studies, and to allow assessment of how directly or completely the participants in the included studies reflect the original review question.

Typically, aspects that should be collected are those that could (or are believed to) affect presence or magnitude of an intervention effect and those that could help review users assess applicability to populations beyond the review. For example, if the review authors suspect important differences in intervention effect between different socio-economic groups, this information should be collected. If intervention effects are thought constant over such groups, and if such information would not be useful to help apply results, it should not be collected. Participant characteristics that are often useful for assessing applicability include age and sex. Summary information about these should always be collected unless they are not obvious from the context. These characteristics are likely to be presented in different formats (e.g. ages as means or medians, with standard deviations or ranges; sex as percentages or counts for the whole study or for each intervention group separately). Review authors should seek consistent quantities where possible, and decide whether it is more relevant to summarize characteristics for the study as a whole or by intervention group. It may not be possible to select the most consistent statistics until data collection is complete across all or most included studies. Other characteristics that are sometimes important include ethnicity, socio-demographic details (e.g. education level) and the presence of comorbid conditions. Clinical characteristics relevant to the review question (e.g. glucose level for reviews on diabetes) also are important for understanding the severity or stage of the disease.

Diagnostic criteria that were used to define the condition of interest can be a particularly important source of diversity across studies and should be collected. For example, in a review of drug therapy for congestive heart failure, it is important to know how the definition and severity of heart failure was determined in each study (e.g. systolic or diastolic dysfunction, severe systolic dysfunction with ejection fractions below 20%). Similarly, in a review of antihypertensive therapy, it is important to describe baseline levels of blood pressure of participants.

If the settings of studies may influence intervention effects or applicability, then information on these should be collected. Typical settings of healthcare intervention studies include acute care hospitals, emergency facilities, general practice, and extended care facilities such as nursing homes, offices, schools, and communities. Sometimes studies are conducted in different geographical regions with important differences that could affect delivery of an intervention and its outcomes, such as cultural characteristics, economic context, or rural versus city settings. Timing of the study may be associated with important technology differences or trends over time. If such information is important for the interpretation of the review, it should be collected.

Important characteristics of the participants in each included study should be summarized for the reader in the table of ‘Characteristics of included studies’.

5.3.4 Interventions

Details of all experimental and comparator interventions of relevance to the review should be collected. Again, details are required for aspects that could affect the presence or magnitude of an effect or that could help review users assess applicability to their own circumstances. Where feasible, information should be sought (and presented in the review) that is sufficient for replication of the interventions under study. This includes any co-interventions administered as part of the study, and applies similarly to comparators such as ‘usual care’. Review authors may need to request missing information from study authors.

The Template for Intervention Description and Replication (TIDieR) provides a comprehensive framework for full description of interventions and has been proposed for use in systematic reviews as well as reports of primary studies (Hoffmann et al 2014). The checklist includes descriptions of:

• the rationale for the intervention and how it is expected to work;
• any documentation that instructs the recipient on the intervention;
• what the providers do to deliver the intervention (procedures and processes);
• who provides the intervention (including their skill level), how (e.g. face to face, web-based) and in what setting (e.g. home, school, or hospital);
• the timing and intensity;
• whether any variation is permitted or expected, and whether modifications were actually made; and
• any strategies used to ensure or assess fidelity or adherence to the intervention, and the extent to which the intervention was delivered as planned.

For clinical trials of pharmacological interventions, key information to collect will often include routes of delivery (e.g. oral or intravenous delivery), doses (e.g. amount or intensity of each treatment, frequency of delivery), timing (e.g. within 24 hours of diagnosis), and length of treatment. For other interventions, such as those that evaluate psychotherapy, behavioural and educational approaches, or healthcare delivery strategies, the amount of information required to characterize the intervention will typically be greater, including information about multiple elements of the intervention, who delivered it, and the format and timing of delivery. Chapter 17 provides further information on how to manage intervention complexity, and how the intervention Complexity Assessment Tool (iCAT) can facilitate data collection (Lewin et al 2017).

Important characteristics of the interventions in each included study should be summarized for the reader in the table of ‘Characteristics of included studies’. Additional tables or diagrams such as logic models ( Chapter 2, Section 2.5.1 ) can assist descriptions of multi-component interventions so that review users can better assess review applicability to their context.

5.3.4.1 Integrity of interventions

The degree to which specified procedures or components of the intervention are implemented as planned can have important consequences for the findings from a study. We describe this as intervention integrity ; related terms include adherence, compliance and fidelity (Carroll et al 2007). The verification of intervention integrity may be particularly important in reviews of non-pharmacological trials such as behavioural interventions and complex interventions, which are often implemented in conditions that present numerous obstacles to idealized delivery.

It is generally expected that reports of randomized trials provide detailed accounts of intervention implementation (Zwarenstein et al 2008, Moher et al 2010). In assessing whether interventions were implemented as planned, review authors should bear in mind that some interventions are standardized (with no deviations permitted in the intervention protocol), whereas others explicitly allow a degree of tailoring (Zwarenstein et al 2008). In addition, the growing field of implementation science has led to an increased awareness of the impact of setting and context on delivery of interventions (Damschroder et al 2009). (See Chapter 17, Section 17.1.2.1 for further information and discussion about how an intervention may be tailored to local conditions in order to preserve its integrity.)

Information about integrity can help determine whether unpromising results are due to a poorly conceptualized intervention or to an incomplete delivery of the prescribed components. It can also reveal important information about the feasibility of implementing a given intervention in real life settings. If it is difficult to achieve full implementation in practice, the intervention will have low feasibility (Dusenbury et al 2003).

Whether a lack of intervention integrity leads to a risk of bias in the estimate of its effect depends on whether review authors and users are interested in the effect of assignment to intervention or the effect of adhering to intervention, as discussed in more detail in Chapter 8, Section 8.2.2 . Assessment of deviations from intended interventions is important for assessing risk of bias in the latter, but not the former (see Chapter 8, Section 8.4 ), but both may be of interest to decision makers in different ways.

An example of a Cochrane Review evaluating intervention integrity is provided by a review of smoking cessation in pregnancy (Chamberlain et al 2017). The authors found that process evaluation of the intervention occurred in only some trials and that the implementation was less than ideal in others, including some of the largest trials. The review highlighted how the transfer of an intervention from one setting to another may reduce its effectiveness when elements are changed, or aspects of the materials are culturally inappropriate.

5.3.4.2 Process evaluations

Process evaluations seek to evaluate the process (and mechanisms) between the intervention’s intended implementation and the actual effect on the outcome (Moore et al 2015). Process evaluation studies are characterized by a flexible approach to data collection and the use of numerous methods to generate a range of different types of data, encompassing both quantitative and qualitative methods. Guidance for including process evaluations in systematic reviews is provided in Chapter 21 . When it is considered important, review authors should aim to collect information on whether the trial accounted for, or measured, key process factors and whether the trials that thoroughly addressed integrity showed a greater impact. Process evaluations can be a useful source of factors that potentially influence the effectiveness of an intervention.

5.3.5 Outcome s

An outcome is an event or a measurement value observed or recorded for a particular person or intervention unit in a study during or following an intervention, and that is used to assess the efficacy and safety of the studied intervention (Meinert 2012). Review authors should indicate in advance whether they plan to collect information about all outcomes measured in a study or only those outcomes of (pre-specified) interest in the review. Research has shown that trials addressing the same condition and intervention seldom agree on which outcomes are the most important, and consequently report on numerous different outcomes (Dwan et al 2014, Ismail et al 2014, Denniston et al 2015, Saldanha et al 2017a). The selection of outcomes across systematic reviews of the same condition is also inconsistent (Page et al 2014, Saldanha et al 2014, Saldanha et al 2016, Liu et al 2017). Outcomes used in trials and in systematic reviews of the same condition have limited overlap (Saldanha et al 2017a, Saldanha et al 2017b).

We recommend that only the outcomes defined in the protocol be described in detail. However, a complete list of the names of all outcomes measured may allow a more detailed assessment of the risk of bias due to missing outcome data (see Chapter 13 ).

Review authors should collect all five elements of an outcome (Zarin et al 2011, Saldanha et al 2014):

1. outcome domain or title (e.g. anxiety);

2. measurement tool or instrument (including definition of clinical outcomes or endpoints); for a scale, name of the scale (e.g. the Hamilton Anxiety Rating Scale), upper and lower limits, and whether a high or low score is favourable, definitions of any thresholds if appropriate;

3. specific metric used to characterize each participant’s results (e.g. post-intervention anxiety, or change in anxiety from baseline to a post-intervention time point, or post-intervention presence of anxiety (yes/no));

4. method of aggregation (e.g. mean and standard deviation of anxiety scores in each group, or proportion of people with anxiety);

5. timing of outcome measurements (e.g. assessments at end of eight-week intervention period, events occurring during eight-week intervention period).

Further considerations for economics outcomes are discussed in Chapter 20 , and for patient-reported outcomes in Chapter 18 .

5.3.5.1 Adverse effects

Collection of information about the harmful effects of an intervention can pose particular difficulties, discussed in detail in Chapter 19 . These outcomes may be described using multiple terms, including ‘adverse event’, ‘adverse effect’, ‘adverse drug reaction’, ‘side effect’ and ‘complication’. Many of these terminologies are used interchangeably in the literature, although some are technically different. Harms might additionally be interpreted to include undesirable changes in other outcomes measured during a study, such as a decrease in quality of life where an improvement may have been anticipated.

In clinical trials, adverse events can be collected either systematically or non-systematically. Systematic collection refers to collecting adverse events in the same manner for each participant using defined methods such as a questionnaire or a laboratory test. For systematically collected outcomes representing harm, data can be collected by review authors in the same way as efficacy outcomes (see Section 5.3.5 ).

Non-systematic collection refers to collection of information on adverse events using methods such as open-ended questions (e.g. ‘Have you noticed any symptoms since your last visit?’), or reported by participants spontaneously. In either case, adverse events may be selectively reported based on their severity, and whether the participant suspected that the effect may have been caused by the intervention, which could lead to bias in the available data. Unfortunately, most adverse events are collected non-systematically rather than systematically, creating a challenge for review authors. The following pieces of information are useful and worth collecting (Nicole Fusco, personal communication):

• any coding system or standard medical terminology used (e.g. COSTART, MedDRA), including version number;
• name of the adverse events (e.g. dizziness);
• reported intensity of the adverse event (e.g. mild, moderate, severe);
• whether the trial investigators categorized the adverse event as ‘serious’;
• whether the trial investigators identified the adverse event as being related to the intervention;
• time point (most commonly measured as a count over the duration of the study);
• any reported methods for how adverse events were selected for inclusion in the publication (e.g. ‘We reported all adverse events that occurred in at least 5% of participants’); and
• associated results.

Different collection methods lead to very different accounting of adverse events (Safer 2002, Bent et al 2006, Ioannidis et al 2006, Carvajal et al 2011, Allen et al 2013). Non-systematic collection methods tend to underestimate how frequently an adverse event occurs. It is particularly problematic when the adverse event of interest to the review is collected systematically in some studies but non-systematically in other studies. Different collection methods introduce an important source of heterogeneity. In addition, when non-systematic adverse events are reported based on quantitative selection criteria (e.g. only adverse events that occurred in at least 5% of participants were included in the publication), use of reported data alone may bias the results of meta-analyses. Review authors should be cautious of (or refrain from) synthesizing adverse events that are collected differently.

Regardless of the collection methods, precise definitions of adverse effect outcomes and their intensity should be recorded, since they may vary between studies. For example, in a review of aspirin and gastrointestinal haemorrhage, some trials simply reported gastrointestinal bleeds, while others reported specific categories of bleeding, such as haematemesis, melaena, and proctorrhagia (Derry and Loke 2000). The definition and reporting of severity of the haemorrhages (e.g. major, severe, requiring hospital admission) also varied considerably among the trials (Zanchetti and Hansson 1999). Moreover, a particular adverse effect may be described or measured in different ways among the studies. For example, the terms ‘tiredness’, ‘fatigue’ or ‘lethargy’ may all be used in reporting of adverse effects. Study authors also may use different thresholds for ‘abnormal’ results (e.g. hypokalaemia diagnosed at a serum potassium concentration of 3.0 mmol/L or 3.5 mmol/L).

No mention of adverse events in trial reports does not necessarily mean that no adverse events occurred. It is usually safest to assume that they were not reported. Quality of life measures are sometimes used as a measure of the participants’ experience during the study, but these are usually general measures that do not look specifically at particular adverse effects of the intervention. While quality of life measures are important and can be used to gauge overall participant well-being, they should not be regarded as substitutes for a detailed evaluation of safety and tolerability.

5.3.6 Results

Results data arise from the measurement or ascertainment of outcomes for individual participants in an intervention study. Results data may be available for each individual in a study (i.e. individual participant data; see Chapter 26 ), or summarized at arm level, or summarized at study level into an intervention effect by comparing two intervention arms. Results data should be collected only for the intervention groups and outcomes specified to be of interest in the protocol (see MECIR Box 5.3.b ). Results for other outcomes should not be collected unless the protocol is modified to add them. Any modification should be reported in the review. However, review authors should be alert to the possibility of important, unexpected findings, particularly serious adverse effects.

MECIR Box 5.3.b Relevant expectations for conduct of intervention reviews

Reports of studies often include several results for the same outcome. For example, different measurement scales might be used, results may be presented separately for different subgroups, and outcomes may have been measured at different follow-up time points. Variation in the results can be very large, depending on which data are selected (Gøtzsche et al 2007, Mayo-Wilson et al 2017a). Review protocols should be as specific as possible about which outcome domains, measurement tools, time points, and summary statistics (e.g. final values versus change from baseline) are to be collected (Mayo-Wilson et al 2017b). A framework should be pre-specified in the protocol to facilitate making choices between multiple eligible measures or results. For example, a hierarchy of preferred measures might be created, or plans articulated to select the result with the median effect size, or to average across all eligible results for a particular outcome domain (see also Chapter 9, Section 9.3.3 ). Any additional decisions or changes to this framework made once the data are collected should be reported in the review as changes to the protocol.

Section 5.6 describes the numbers that will be required to perform meta-analysis, if appropriate. The unit of analysis (e.g. participant, cluster, body part, treatment period) should be recorded for each result when it is not obvious (see Chapter 6, Section 6.2 ). The type of outcome data determines the nature of the numbers that will be sought for each outcome. For example, for a dichotomous (‘yes’ or ‘no’) outcome, the number of participants and the number who experienced the outcome will be sought for each group. It is important to collect the sample size relevant to each result, although this is not always obvious. A flow diagram as recommended in the CONSORT Statement (Moher et al 2001) can help to determine the flow of participants through a study. If one is not available in a published report, review authors can consider drawing one (available from www.consort-statement.org ).

The numbers required for meta-analysis are not always available. Often, other statistics can be collected and converted into the required format. For example, for a continuous outcome, it is usually most convenient to seek the number of participants, the mean and the standard deviation for each intervention group. These are often not available directly, especially the standard deviation. Alternative statistics enable calculation or estimation of the missing standard deviation (such as a standard error, a confidence interval, a test statistic (e.g. from a t-test or F-test) or a P value). These should be extracted if they provide potentially useful information (see MECIR Box 5.3.c ). Details of recalculation are provided in Section 5.6 . Further considerations for dealing with missing data are discussed in Chapter 10, Section 10.12 .

MECIR Box 5.3.c Relevant expectations for conduct of intervention reviews

5.3.7 Other information to collect

We recommend that review authors collect the key conclusions of the included study as reported by its authors. It is not necessary to report these conclusions in the review, but they should be used to verify the results of analyses undertaken by the review authors, particularly in relation to the direction of effect. Further comments by the study authors, for example any explanations they provide for unexpected findings, may be noted. References to other studies that are cited in the study report may be useful, although review authors should be aware of the possibility of citation bias (see Chapter 7, Section 7.2.3.2 ). Documentation of any correspondence with the study authors is important for review transparency.

5.4 Data collection tools

5.4.1 rationale for data collection forms.

Data collection for systematic reviews should be performed using structured data collection forms (see MECIR Box 5.4.a ). These can be paper forms, electronic forms (e.g. Google Form), or commercially or custom-built data systems (e.g. Covidence, EPPI-Reviewer, Systematic Review Data Repository (SRDR)) that allow online form building, data entry by several users, data sharing, and efficient data management (Li et al 2015). All different means of data collection require data collection forms.

MECIR Box 5.4.a Relevant expectations for conduct of intervention reviews

The data collection form is a bridge between what is reported by the original investigators (e.g. in journal articles, abstracts, personal correspondence) and what is ultimately reported by the review authors. The data collection form serves several important functions (Meade and Richardson 1997). First, the form is linked directly to the review question and criteria for assessing eligibility of studies, and provides a clear summary of these that can be used to identify and structure the data to be extracted from study reports. Second, the data collection form is the historical record of the provenance of the data used in the review, as well as the multitude of decisions (and changes to decisions) that occur throughout the review process. Third, the form is the source of data for inclusion in an analysis.

Given the important functions of data collection forms, ample time and thought should be invested in their design. Because each review is different, data collection forms will vary across reviews. However, there are many similarities in the types of information that are important. Thus, forms can be adapted from one review to the next. Although we use the term ‘data collection form’ in the singular, in practice it may be a series of forms used for different purposes: for example, a separate form could be used to assess the eligibility of studies for inclusion in the review to assist in the quick identification of studies to be excluded from or included in the review.

5.4.2 Considerations in selecting data collection tools

The choice of data collection tool is largely dependent on review authors’ preferences, the size of the review, and resources available to the author team. Potential advantages and considerations of selecting one data collection tool over another are outlined in Table 5.4.a (Li et al 2015). A significant advantage that data systems have is in data management ( Chapter 1, Section 1.6 ) and re-use. They make review updates more efficient, and also facilitate methodological research across reviews. Numerous ‘meta-epidemiological’ studies have been carried out using Cochrane Review data, resulting in methodological advances which would not have been possible if thousands of studies had not all been described using the same data structures in the same system.

Some data collection tools facilitate automatic imports of extracted data into RevMan (Cochrane’s authoring tool), such as CSV (Excel) and Covidence. Details available here https://documentation.cochrane.org/revman-kb/populate-study-data-260702462.html

Table 5.4.a Considerations in selecting data collection tools

5.4.3 Design of a data collection form

Regardless of whether data are collected using a paper or electronic form, or a data system, the key to successful data collection is to construct easy-to-use forms and collect sufficient and unambiguous data that faithfully represent the source in a structured and organized manner (Li et al 2015). In most cases, a document format should be developed for the form before building an electronic form or a data system. This can be distributed to others, including programmers and data analysts, and as a guide for creating an electronic form and any guidance or codebook to be used by data extractors. Review authors also should consider compatibility of any electronic form or data system with analytical software, as well as mechanisms for recording, assessing and correcting data entry errors.

Data described in multiple reports (or even within a single report) of a study may not be consistent. Review authors will need to describe how they work with multiple reports in the protocol, for example, by pre-specifying which report will be used when sources contain conflicting data that cannot be resolved by contacting the investigators. Likewise, when there is only one report identified for a study, review authors should specify the section within the report (e.g. abstract, methods, results, tables, and figures) for use in case of inconsistent information.

If review authors wish to automatically import their extracted data into RevMan, it is advised that their data collection forms match the data extraction templates available via the RevMan Knowledge Base. Details available here https://documentation.cochrane.org/revman-kb/data-extraction-templates-260702375.html.

A good data collection form should minimize the need to go back to the source documents. When designing a data collection form, review authors should involve all members of the team, that is, content area experts, authors with experience in systematic review methods and data collection form design, statisticians, and persons who will perform data extraction. Here are suggested steps and some tips for designing a data collection form, based on the informal collation of experiences from numerous review authors (Li et al 2015).

Step 1. Develop outlines of tables and figures expected to appear in the systematic review, considering the comparisons to be made between different interventions within the review, and the various outcomes to be measured. This step will help review authors decide the right amount of data to collect (not too much or too little). Collecting too much information can lead to forms that are longer than original study reports, and can be very wasteful of time. Collection of too little information, or omission of key data, can lead to the need to return to study reports later in the review process.

Step 2. Assemble and group data elements to facilitate form development. Review authors should consult Table 5.3.a , in which the data elements are grouped to facilitate form development and data collection. Note that it may be more efficient to group data elements in the order in which they are usually found in study reports (e.g. starting with reference information, followed by eligibility criteria, intervention description, statistical methods, baseline characteristics and results).

Step 3. Identify the optimal way of framing the data items. Much has been written about how to frame data items for developing robust data collection forms in primary research studies. We summarize a few key points and highlight issues that are pertinent to systematic reviews.

• Ask closed-ended questions (i.e. questions that define a list of permissible responses) as much as possible. Closed-ended questions do not require post hoc coding and provide better control over data quality than open-ended questions. When setting up a closed-ended question, one must anticipate and structure possible responses and include an ‘other, specify’ category because the anticipated list may not be exhaustive. Avoid asking data extractors to summarize data into uncoded text, no matter how short it is.
• Avoid asking a question in a way that the response may be left blank. Include ‘not applicable’, ‘not reported’ and ‘cannot tell’ options as needed. The ‘cannot tell’ option tags uncertain items that may promote review authors to contact study authors for clarification, especially on data items critical to reach conclusions.
• Remember that the form will focus on what is reported in the article rather what has been done in the study. The study report may not fully reflect how the study was actually conducted. For example, a question ‘Did the article report that the participants were masked to the intervention?’ is more appropriate than ‘Were participants masked to the intervention?’
• Where a judgement is required, record the raw data (i.e. quote directly from the source document) used to make the judgement. It is also important to record the source of information collected, including where it was found in a report or whether information was obtained from unpublished sources or personal communications. As much as possible, questions should be asked in a way that minimizes subjective interpretation and judgement to facilitate data comparison and adjudication.
• Incorporate flexibility to allow for variation in how data are reported. It is strongly recommended that outcome data be collected in the format in which they were reported and transformed in a subsequent step if required. Review authors also should consider the software they will use for analysis and for publishing the review (e.g. RevMan).

Step 4. Develop and pilot-test data collection forms, ensuring that they provide data in the right format and structure for subsequent analysis. In addition to data items described in Step 2, data collection forms should record the title of the review as well as the person who is completing the form and the date of completion. Forms occasionally need revision; forms should therefore include the version number and version date to reduce the chances of using an outdated form by mistake. Because a study may be associated with multiple reports, it is important to record the study ID as well as the report ID. Definitions and instructions helpful for answering a question should appear next to the question to improve quality and consistency across data extractors (Stock 1994). Provide space for notes, regardless of whether paper or electronic forms are used.

All data collection forms and data systems should be thoroughly pilot-tested before launch (see MECIR Box 5.4.a ). Testing should involve several people extracting data from at least a few articles. The initial testing focuses on the clarity and completeness of questions. Users of the form may provide feedback that certain coding instructions are confusing or incomplete (e.g. a list of options may not cover all situations). The testing may identify data that are missing from the form, or likely to be superfluous. After initial testing, accuracy of the extracted data should be checked against the source document or verified data to identify problematic areas. It is wise to draft entries for the table of ‘Characteristics of included studies’ and complete a risk of bias assessment ( Chapter 8 ) using these pilot reports to ensure all necessary information is collected. A consensus between review authors may be required before the form is modified to avoid any misunderstandings or later disagreements. It may be necessary to repeat the pilot testing on a new set of reports if major changes are needed after the first pilot test.

Problems with the data collection form may surface after pilot testing has been completed, and the form may need to be revised after data extraction has started. When changes are made to the form or coding instructions, it may be necessary to return to reports that have already undergone data extraction. In some situations, it may be necessary to clarify only coding instructions without modifying the actual data collection form.

5.5 Extracting data from reports

5.5.1 introduction.

In most systematic reviews, the primary source of information about each study is published reports of studies, usually in the form of journal articles. Despite recent developments in machine learning models to automate data extraction in systematic reviews (see Section 5.5.9 ), data extraction is still largely a manual process. Electronic searches for text can provide a useful aid to locating information within a report. Examples include using search facilities in PDF viewers, internet browsers and word processing software. However, text searching should not be considered a replacement for reading the report, since information may be presented using variable terminology and presented in multiple formats.

5.5.2 Who should extract data?

Data extractors should have at least a basic understanding of the topic, and have knowledge of study design, data analysis and statistics. They should pay attention to detail while following instructions on the forms. Because errors that occur at the data extraction stage are rarely detected by peer reviewers, editors, or users of systematic reviews, it is recommended that more than one person extract data from every report to minimize errors and reduce introduction of potential biases by review authors (see MECIR Box 5.5.a ). As a minimum, information that involves subjective interpretation and information that is critical to the interpretation of results (e.g. outcome data) should be extracted independently by at least two people (see MECIR Box 5.5.a ). In common with implementation of the selection process ( Chapter 4, Section 4.6 ), it is preferable that data extractors are from complementary disciplines, for example a methodologist and a topic area specialist. It is important that everyone involved in data extraction has practice using the form and, if the form was designed by someone else, receives appropriate training.

Evidence in support of duplicate data extraction comes from several indirect sources. One study observed that independent data extraction by two authors resulted in fewer errors than data extraction by a single author followed by verification by a second (Buscemi et al 2006). A high prevalence of data extraction errors (errors in 20 out of 34 reviews) has been observed (Jones et al 2005). A further study of data extraction to compute standardized mean differences found that a minimum of seven out of 27 reviews had substantial errors (Gøtzsche et al 2007).

MECIR Box 5.5.a Relevant expectations for conduct of intervention reviews

5.5.3 Training data extractors

Training of data extractors is intended to familiarize them with the review topic and methods, the data collection form or data system, and issues that may arise during data extraction. Results of the pilot testing of the form should prompt discussion among review authors and extractors of ambiguous questions or responses to establish consistency. Training should take place at the onset of the data extraction process and periodically over the course of the project (Li et al 2015). For example, when data related to a single item on the form are present in multiple locations within a report (e.g. abstract, main body of text, tables, and figures) or in several sources (e.g. publications, ClinicalTrials.gov, or CSRs), the development and documentation of instructions to follow an agreed algorithm are critical and should be reinforced during the training sessions.

Some have proposed that some information in a report, such as its authors, be blinded to the review author prior to data extraction and assessment of risk of bias (Jadad et al 1996). However, blinding of review authors to aspects of study reports generally is not recommended for Cochrane Reviews as there is little evidence that it alters the decisions made (Berlin 1997).

5.5.4 Extracting data from multiple reports of the same study

Studies frequently are reported in more than one publication or in more than one source (Tramèr et al 1997, von Elm et al 2004). A single source rarely provides complete information about a study; on the other hand, multiple sources may contain conflicting information about the same study (Mayo-Wilson et al 2017a, Mayo-Wilson et al 2017b, Mayo-Wilson et al 2018). Because the unit of interest in a systematic review is the study and not the report, information from multiple reports often needs to be collated and reconciled. It is not appropriate to discard any report of an included study without careful examination, since it may contain valuable information not included in the primary report. Review authors will need to decide between two strategies:

• Extract data from each report separately, then combine information across multiple data collection forms.
• Extract data from all reports directly into a single data collection form.

The choice of which strategy to use will depend on the nature of the reports and may vary across studies and across reports. For example, when a full journal article and multiple conference abstracts are available, it is likely that the majority of information will be obtained from the journal article; completing a new data collection form for each conference abstract may be a waste of time. Conversely, when there are two or more detailed journal articles, perhaps relating to different periods of follow-up, then it is likely to be easier to perform data extraction separately for these articles and collate information from the data collection forms afterwards. When data from all reports are extracted into a single data collection form, review authors should identify the ‘main’ data source for each study when sources include conflicting data and these differences cannot be resolved by contacting authors (Mayo-Wilson et al 2018). Flow diagrams such as those modified from the PRISMA statement can be particularly helpful when collating and documenting information from multiple reports (Mayo-Wilson et al 2018).

5.5.5 Reliability and reaching consensus

When more than one author extracts data from the same reports, there is potential for disagreement. After data have been extracted independently by two or more extractors, responses must be compared to assure agreement or to identify discrepancies. An explicit procedure or decision rule should be specified in the protocol for identifying and resolving disagreements. Most often, the source of the disagreement is an error by one of the extractors and is easily resolved. Thus, discussion among the authors is a sensible first step. More rarely, a disagreement may require arbitration by another person. Any disagreement that cannot be resolved should be addressed by contacting the study authors; if this is unsuccessful, the disagreement should be reported in the review.

The presence and resolution of disagreements should be carefully recorded. Maintaining a copy of the data ‘as extracted’ (in addition to the consensus data) allows assessment of reliability of coding. Examples of ways in which this can be achieved include the following:

• Use one author’s (paper) data collection form and record changes after consensus in a different ink colour.
• Enter consensus data onto an electronic form.
• Record original data extracted and consensus data in separate forms (some online tools do this automatically).

Agreement of coded items before reaching consensus can be quantified, for example using kappa statistics (Orwin 1994), although this is not routinely done in Cochrane Reviews. If agreement is assessed, this should be done only for the most important data (e.g. key risk of bias assessments, or availability of key outcomes).

Throughout the review process informal consideration should be given to the reliability of data extraction. For example, if after reaching consensus on the first few studies, the authors note a frequent disagreement for specific data, then coding instructions may need modification. Furthermore, an author’s coding strategy may change over time, as the coding rules are forgotten, indicating a need for retraining and, possibly, some recoding.

5.5.6 Extracting data from clinical study reports

Clinical study reports (CSRs) obtained for a systematic review are likely to be in PDF format. Although CSRs can be thousands of pages in length and very time-consuming to review, they typically follow the content and format required by the International Conference on Harmonisation (ICH 1995). Information in CSRs is usually presented in a structured and logical way. For example, numerical data pertaining to important demographic, efficacy, and safety variables are placed within the main text in tables and figures. Because of the clarity and completeness of information provided in CSRs, data extraction from CSRs may be clearer and conducted more confidently than from journal articles or other short reports.

To extract data from CSRs efficiently, review authors should familiarize themselves with the structure of the CSRs. In practice, review authors may want to browse or create ‘bookmarks’ within a PDF document that record section headers and subheaders and search key words related to the data extraction (e.g. randomization). In addition, it may be useful to utilize optical character recognition software to convert tables of data in the PDF to an analysable format when additional analyses are required, saving time and minimizing transcription errors.

CSRs may contain many outcomes and present many results for a single outcome (due to different analyses) (Mayo-Wilson et al 2017b). We recommend review authors extract results only for outcomes of interest to the review (Section 5.3.6 ). With regard to different methods of analysis, review authors should have a plan and pre-specify preferred metrics in their protocol for extracting results pertaining to different populations (e.g. ‘all randomized’, ‘all participants taking at least one dose of medication’), methods for handling missing data (e.g. ‘complete case analysis’, ‘multiple imputation’), and adjustment (e.g. unadjusted, adjusted for baseline covariates). It may be important to record the range of analysis options available, even if not all are extracted in detail. In some cases it may be preferable to use metrics that are comparable across multiple included studies, which may not be clear until data collection for all studies is complete.

CSRs are particularly useful for identifying outcomes assessed but not presented to the public. For efficacy outcomes and systematically collected adverse events, review authors can compare what is described in the CSRs with what is reported in published reports to assess the risk of bias due to missing outcome data ( Chapter 8, Section 8.5 ) and in selection of reported result ( Chapter 8, Section 8.7 ). Note that non-systematically collected adverse events are not amenable to such comparisons because these adverse events may not be known ahead of time and thus not pre-specified in the protocol.

5.5.7 Extracting data from regulatory reviews

Data most relevant to systematic reviews can be found in the medical and statistical review sections of a regulatory review. Both of these are substantially longer than journal articles (Turner 2013). A list of all trials on a drug usually can be found in the medical review. Because trials are referenced by a combination of numbers and letters, it may be difficult for the review authors to link the trial with other reports of the same trial (Section 5.2.1 ).

Many of the documents downloaded from the US Food and Drug Administration’s website for older drugs are scanned copies and are not searchable because of redaction of confidential information (Turner 2013). Optical character recognition software can convert most of the text. Reviews for newer drugs have been redacted electronically; documents remain searchable as a result.

Compared to CSRs, regulatory reviews contain less information about trial design, execution, and results. They provide limited information for assessing the risk of bias. In terms of extracting outcomes and results, review authors should follow the guidance provided for CSRs (Section 5.5.6 ).

5.5.8 Extracting data from figures with software

Sometimes numerical data needed for systematic reviews are only presented in figures. Review authors may request the data from the study investigators, or alternatively, extract the data from the figures either manually (e.g. with a ruler) or by using software. Numerous tools are available, many of which are free. Those available at the time of writing include tools called Plot Digitizer, WebPlotDigitizer, Engauge, Dexter, ycasd, GetData Graph Digitizer. The software works by taking an image of a figure and then digitizing the data points off the figure using the axes and scales set by the users. The numbers exported can be used for systematic reviews, although additional calculations may be needed to obtain the summary statistics, such as calculation of means and standard deviations from individual-level data points (or conversion of time-to-event data presented on Kaplan-Meier plots to hazard ratios; see Chapter 6, Section 6.8.2 ).

It has been demonstrated that software is more convenient and accurate than visual estimation or use of a ruler (Gross et al 2014, Jelicic Kadic et al 2016). Review authors should consider using software for extracting numerical data from figures when the data are not available elsewhere.

5.5.9 Automating data extraction in systematic reviews

Because data extraction is time-consuming and error-prone, automating or semi-automating this step may make the extraction process more efficient and accurate. The state of science relevant to automating data extraction is summarized here (Jonnalagadda et al 2015).

• At least 26 studies have tested various natural language processing and machine learning approaches for facilitating data extraction for systematic reviews.

· Each tool focuses on only a limited number of data elements (ranges from one to seven). Most of the existing tools focus on the PICO information (e.g. number of participants, their age, sex, country, recruiting centres, intervention groups, outcomes, and time points). A few are able to extract study design and results (e.g. objectives, study duration, participant flow), and two extract risk of bias information (Marshall et al 2016, Millard et al 2016). To date, well over half of the data elements needed for systematic reviews have not been explored for automated extraction.

• Most tools highlight the sentence(s) that may contain the data elements as opposed to directly recording these data elements into a data collection form or a data system.
• There is no gold standard or common dataset to evaluate the performance of these tools, limiting our ability to interpret the significance of the reported accuracy measures.

At the time of writing, we cannot recommend a specific tool for automating data extraction for routine systematic review production. There is a need for review authors to work with experts in informatics to refine these tools and evaluate them rigorously. Such investigations should address how the tool will fit into existing workflows. For example, the automated or semi-automated data extraction approaches may first act as checks for manual data extraction before they can replace it.

5.5.10 Suspicions of scientific misconduct

Systematic review authors can uncover suspected misconduct in the published literature. Misconduct includes fabrication or falsification of data or results, plagiarism, and research that does not adhere to ethical norms. Review authors need to be aware of scientific misconduct because the inclusion of fraudulent material could undermine the reliability of a review’s findings. Plagiarism of results data in the form of duplicated publication (either by the same or by different authors) may, if undetected, lead to study participants being double counted in a synthesis.

It is preferable to identify potential problems before, rather than after, publication of the systematic review, so that readers are not misled. However, empirical evidence indicates that the extent to which systematic review authors explore misconduct varies widely (Elia et al 2016). Text-matching software and systems such as CrossCheck may be helpful for detecting plagiarism, but they can detect only matching text, so data tables or figures need to be inspected by hand or using other systems (e.g. to detect image manipulation). Lists of data such as in a meta-analysis can be a useful means of detecting duplicated studies. Furthermore, examination of baseline data can lead to suspicions of misconduct for an individual randomized trial (Carlisle et al 2015). For example, Al-Marzouki and colleagues concluded that a trial report was fabricated or falsified on the basis of highly unlikely baseline differences between two randomized groups (Al-Marzouki et al 2005).

Cochrane Review authors are advised to consult with Cochrane editors if cases of suspected misconduct are identified. Searching for comments, letters or retractions may uncover additional information. Sensitivity analyses can be used to determine whether the studies arousing suspicion are influential in the conclusions of the review. Guidance for editors for addressing suspected misconduct will be available from Cochrane’s Editorial Publishing and Policy Resource (see community.cochrane.org ). Further information is available from the Committee on Publication Ethics (COPE; publicationethics.org ), including a series of flowcharts on how to proceed if various types of misconduct are suspected. Cases should be followed up, typically including an approach to the editors of the journals in which suspect reports were published. It may be useful to write first to the primary investigators to request clarification of apparent inconsistencies or unusual observations.

Because investigations may take time, and institutions may not always be responsive (Wager 2011), articles suspected of being fraudulent should be classified as ‘awaiting assessment’. If a misconduct investigation indicates that the publication is unreliable, or if a publication is retracted, it should not be included in the systematic review, and the reason should be noted in the ‘excluded studies’ section.

5.5.11 Key points in planning and reporting data extraction

In summary, the methods section of both the protocol and the review should detail:

• the data categories that are to be extracted;
• how extracted data from each report will be verified (e.g. extraction by two review authors, independently);
• whether data extraction is undertaken by content area experts, methodologists, or both;
• pilot testing, training and existence of coding instructions for the data collection form;
• how data are extracted from multiple reports from the same study; and
• how disagreements are handled when more than one author extracts data from each report.

5.6 Extracting study results and converting to the desired format

In most cases, it is desirable to collect summary data separately for each intervention group of interest and to enter these into software in which effect estimates can be calculated, such as RevMan. Sometimes the required data may be obtained only indirectly, and the relevant results may not be obvious. Chapter 6 provides many useful tips and techniques to deal with common situations. When summary data cannot be obtained from each intervention group, or where it is important to use results of adjusted analyses (for example to account for correlations in crossover or cluster-randomized trials) effect estimates may be available directly.

5.7 Managing and sharing data

When data have been collected for each individual study, it is helpful to organize them into a comprehensive electronic format, such as a database or spreadsheet, before entering data into a meta-analysis or other synthesis. When data are collated electronically, all or a subset of them can easily be exported for cleaning, consistency checks and analysis.

Tabulation of collected information about studies can facilitate classification of studies into appropriate comparisons and subgroups. It also allows identification of comparable outcome measures and statistics across studies. It will often be necessary to perform calculations to obtain the required statistics for presentation or synthesis. It is important through this process to retain clear information on the provenance of the data, with a clear distinction between data from a source document and data obtained through calculations. Statistical conversions, for example from standard errors to standard deviations, ideally should be undertaken with a computer rather than using a hand calculator to maintain a permanent record of the original and calculated numbers as well as the actual calculations used.

Ideally, data only need to be extracted once and should be stored in a secure and stable location for future updates of the review, regardless of whether the original review authors or a different group of authors update the review (Ip et al 2012). Standardizing and sharing data collection tools as well as data management systems among review authors working in similar topic areas can streamline systematic review production. Review authors have the opportunity to work with trialists, journal editors, funders, regulators, and other stakeholders to make study data (e.g. CSRs, IPD, and any other form of study data) publicly available, increasing the transparency of research. When legal and ethical to do so, we encourage review authors to share the data used in their systematic reviews to reduce waste and to allow verification and reanalysis because data will not have to be extracted again for future use (Mayo-Wilson et al 2018).

5.8 Chapter information

Editors: Tianjing Li, Julian PT Higgins, Jonathan J Deeks

Acknowledgements: This chapter builds on earlier versions of the Handbook . For details of previous authors and editors of the Handbook , see Preface. Andrew Herxheimer, Nicki Jackson, Yoon Loke, Deirdre Price and Helen Thomas contributed text. Stephanie Taylor and Sonja Hood contributed suggestions for designing data collection forms. We are grateful to Judith Anzures, Mike Clarke, Miranda Cumpston and Peter Gøtzsche for helpful comments.

Funding: JPTH is a member of the National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JJD received support from the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. JPTH received funding from National Institute for Health Research Senior Investigator award NF-SI-0617-10145. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

5.9 References

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Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014; 348 : g1687.

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Ioannidis JPA, Mulrow CD, Goodman SN. Adverse events: The more you search, the more you find. Annals of Internal Medicine 2006; 144 : 298-300.

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Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, McQuay H. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Controlled Clinical Trials 1996; 17 : 1-12.

Jelicic Kadic A, Vucic K, Dosenovic S, Sapunar D, Puljak L. Extracting data from figures with software was faster, with higher interrater reliability than manual extraction. Journal of Clinical Epidemiology 2016; 74 : 119-123.

Jones AP, Remmington T, Williamson PR, Ashby D, Smyth RL. High prevalence but low impact of data extraction and reporting errors were found in Cochrane systematic reviews. Journal of Clinical Epidemiology 2005; 58 : 741-742.

Jones CW, Keil LG, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Medicine 2015; 13 : 282.

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Lewin S, Hendry M, Chandler J, Oxman AD, Michie S, Shepperd S, Reeves BC, Tugwell P, Hannes K, Rehfuess EA, Welch V, McKenzie JE, Burford B, Petkovic J, Anderson LM, Harris J, Noyes J. Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR). BMC Medical Research Methodology 2017; 17 : 76.

Li G, Abbade LPF, Nwosu I, Jin Y, Leenus A, Maaz M, Wang M, Bhatt M, Zielinski L, Sanger N, Bantoto B, Luo C, Shams I, Shahid H, Chang Y, Sun G, Mbuagbaw L, Samaan Z, Levine MAH, Adachi JD, Thabane L. A scoping review of comparisons between abstracts and full reports in primary biomedical research. BMC Medical Research Methodology 2017; 17 : 181.

Li TJ, Vedula SS, Hadar N, Parkin C, Lau J, Dickersin K. Innovations in data collection, management, and archiving for systematic reviews. Annals of Internal Medicine 2015; 162 : 287-294.

Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JPA, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Medicine 2009; 6 : e1000100.

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Mayo-Wilson E, Li TJ, Fusco N, Bertizzolo L, Canner JK, Cowley T, Doshi P, Ehmsen J, Gresham G, Guo N, Haythomthwaite JA, Heyward J, Hong H, Pham D, Payne JL, Rosman L, Stuart EA, Suarez-Cuervo C, Tolbert E, Twose C, Vedula S, Dickersin K. Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy. Journal of Clinical Epidemiology 2017a; 91 : 95-110.

Mayo-Wilson E, Fusco N, Li TJ, Hong H, Canner JK, Dickersin K, MUDS Investigators. Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. Journal of Clinical Epidemiology 2017b; 86 : 39-50.

Mayo-Wilson E, Li T, Fusco N, Dickersin K. Practical guidance for using multiple data sources in systematic reviews and meta-analyses (with examples from the MUDS study). Research Synthesis Methods 2018; 9 : 2-12.

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Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340 : c869.

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Saldanha IJ, Li T, Yang C, Ugarte-Gil C, Rutherford GW, Dickersin K. Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS. Journal of Clinical Epidemiology 2016; 70 : 164-175.

Saldanha IJ, Lindsley K, Do DV, Chuck RS, Meyerle C, Jones LS, Coleman AL, Jampel HD, Dickersin K, Virgili G. Comparison of clinical trial and systematic review outcomes for the 4 most prevalent eye diseases. JAMA Ophthalmology 2017a; 135 : 933-940.

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Data Collection Methods

This InfoGuide assists students starting their research proposal and literature review.

• Introduction
• Research Process
• Types of Research Methodology
• Anatomy of a Scholarly Article
• Finding a topic
• Identifying a Research Problem
• Problem Statement
• Research Question
• Research Design
• Search Strategies
• Psychology Database Limiters
• Literature Review Search
• Annotated Bibliography
• Writing a Literature Review
• Writing a Research Proposal

Quantitative and qualitative data can be collected using various methods. It is important to use a data collection method to help answer your research question(s).

Many data collection methods can be either qualitative or quantitative. For example, in surveys, observational studies or case studies, your data can be represented as numbers (e.g., using rating scales or counting frequencies) or as words (e.g., with open-ended questions or descriptions of what you observe).

However, some methods are more commonly used in one type or the other.

Quantiative & Qualitative Data Collection Methods

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Literature review

Chapter 3 research methodology, 3.5 data collection methods, 3.5.1 literature review.

A literature review is often undertaken prior to empirical research as it provides a synthesis of the extant knowledge on a given topic. The scope of a literature review can vary. The emphasis may be on a review of research methods to determine which approach to adopt or examination of current knowledge to inform policy decisions. An essay style review was criticised by Hakim (1992, pp.18-19) for its subjective approach and partial coverage. The preferred style is a meta-analysis which introduces more rigour into the process. Meta-analysis involves statistical analysis to highlight significance in reported study findings. It is a useful tool for reviews of quantitative studies but is not believed to be as appropriate for reviews of qualitative studies (Hakim 1992, pp.19-20). An alternative approach is to carry out a systematic review where explicit procedures are followed making bias less likely to occur (Bryman 2008, p.85). Systematic reviews involve a series of defined steps:

• purpose statement;

• criteria for selection of published works; • all in-scope works are included in the review;

• study features recorded against a defined protocol (location, sample size, data collection methods and key findings); and

• results summarised and synthesised, possibly presented in a table (Millar 2004, p.145).

One limitation of a systematic review is that differences between studies are not highlighted, resulting in a loss of important detail (Millar 2004, p.146).

A narrative or descriptive literature review is useful for gaining an insight into a topic which is further understood by empirical research. This form of review is more wide ranging, exploratory and not as clearly defined as other types of literature review (Bryman 2008, pp.92-93). Prior studies are compared for trends or patterns in their results (Millar 2004, p.142).

Literature reviews are advantageous because they can be conducted relatively quickly with little cost. They are, however, limited to published literature which may not adequately cover areas under investigation (Hakim 1992, p.24).

3.5.2 Questionnaires

The criteria for research questionnaires are that they should:

• collect information for analysis;

• comprise a set list of questions which is presented to all respondents; and • gather information directly from subjects (Denscombe 2007, pp.153-154)

They are ideal tools to use where the researcher wishes to gather information from a large number of individuals who are geographically dispersed, where standard data are required and respondents have the ability to understand the questions being asked. Questionnaires tend to gather information around ‘facts’ or ‘opinions’ and the researcher must have no ambiguities regarding the focus of their investigation (Denscombe 2007, pp.154-155).

The length and complexity of the questionnaire is a matter of judgement for the researcher. The decision needs to be made by taking into account the audience and time required to complete the questionnaire, however, a major deterrent to completion is its size. Therefore, key research issues should be addressed by the questionnaire (Denscombe 2007, pp.161-162). In addition, when compared with interviews, self-completion questionnaires need to be easy to follow, short to minimise the risk of survey fatigue, and have a limited number of open questions as closed questions are easier to answer in the absence of an interviewer to guide the process (Bryman 2008, p.217).

Prior to releasing a questionnaire to its intended audience it needs to be tested and refined. This pilot process ensures optimal wording and question ordering, tests letters of introduction and analysis of pilot data assists in developing a plan for final data analysis (Oppenheim 1992, pp.47-64).

One of the weaknesses of structured questionnaires is that they provide less depth of information than interviews (Hakim 1992, p.49). To be effective the researcher needs to ensure that questionnaire respondents mirror the wider target population. Failure to do so can introduce bias into the results. Responses also need to be an accurate measure of respondent characteristics (Fowler 2009, pp.12-14).

3.5.3 Interviews

Interviews are a useful source of preliminary information for the researcher and they can help to frame the research to follow (Blakeslee & Fleischer 2007, pp.30-31). In this respect they provide a mechanism for identifying issues and themes. They are also used to obtain in-depth data when “information based on insider experience, privileged insights and experiences” are required (Wisker 2001, p.165). Interviews can take a variety of formats from formal structured, through semi-structured to informal or opportunistic. Formal interviews follow a set structure and question list; for the researcher they are a way of gathering a standard set of data which is consistent across all

interviewees (Blakeslee & Fleischer 2007, p.133). Semi-structured interviews have a defined list of questions but provide scope for discussion (Wisker 2001, pp.168-169).

Interviews are conducted from the perspective of the interviewer; their views will have a bearing on the interview process and subsequent analysis of the transcript. It is therefore important to follow ethical practices, to avoid bias and to be open to the views of the interviewee (Wisker 2001, pp.142-143).

One of the drawbacks of adopting interviews as a research method is that they are time consuming (Gillham 2000, pp.65-66; Wisker 2001, 165). Thus, it is advisable to maintain a focus on the research topic (Blakeslee & Fleischer 2007, 138-139; Gillham 2000, pp.65-66).

3.5.4 Document analysis

Document analysis draws on written, visual and audio files from a range of sources. Written documents include Government publications, newspapers, meeting notes, letters, diaries or webpages. Particularly attractive sources of data for researchers are those which are freely available and accessible. Documents that are not freely available require the researcher to negotiate access or undertake undercover activities to source. Researchers need to assess the validity of the documents they examine; for a website this involves consideration of the authority of the source, trustworthiness of the website, whether information is up-to-date and the popularity of the website (Denscombe 2007, pp.227-234).

When conducting research based on documents the context within which these artefacts were created and the intended audience should be considered. Bryman (2008, p.527) offered the example of an organisation’s meeting minutes which may have been crafted to exclude certain discussions because they could be accessed by members of the public. Background information to meeting minutes might also be available internally, thus connecting them to wider internal events. Researchers may have to probe into the broader

3.6 Data analysis

In quantitative data analysis facts expressed in numerical form are used to test hypotheses (Neuman 2007, p.329). Raw data are processed by software and charts or graphs representing these data produced. Summaries of the data are explained and given meaning by the researcher (Merriam 1998, p.178; Neuman 2007, p.248). Qualitative data consists of words, photographs and other materials which require a different treatment for analysis. Researchers begin data analysis early in their research by looking for patterns and relationships in the data (Neuman 2007, p.329). Data analysis is achieved through a series of steps which involve preparing, coding, identifying themes and presentation (Creswell 2007, p.148). These activities are broken down into six stages: data managing, reading/memoing, describing, classifying, interpreting, and representing/visualising. The following activities are carried out during the process of collating and comparing these data:

• data managing: creating and organising files for the data;

• reading/memoing: reading, note taking in the margins and initial coding;

• describing, classifying and interpreting: describing the data and its context; analysing to identify themes and patterns; making sense of the data and bringing meaning to its interpretation; and

• representing/visualising: findings are presented by narration and visual representations (models, tables, figures or sketches) (Creswell 2007, pp.156-157).

Data analysis is designed to aid the understanding of an event; therefore, core elements of complex events are identified. Data are studied for themes, common issues, words or phrases. These are coded (tagged) into broad categories to develop an understanding of a phenomenon. Codes are not fixed; they change and develop as the research progresses. Thus, initial coding is descriptive and applied to broad chunks of text (open coding). Relationships between codes aids identification of key (axial) components and this leads on to a more focused effort on the core codes (selective coding) which are essential in explaining phenomena (Denscombe 2007, pp.97-98).

This approach is mirrored in the analysis of case study research data. Where data are interpreted and analysed for patterns in order to gain an understanding of the case and surrounding influences and conditions. The researcher questions the data, reading it over and again; taking the time to reflect on the data, their assumptions and analysis. In this way meaning and significance can be better understood and through coding and triangulation the process is enhanced (Stake 1995, pp.78-79).

Stake (1995, p.108) noted that “All researchers recognize the need not only for being accurate in measuring things but logical in interpreting the meaning of those measurements.” The protocol by which this validation is achieved is triangulation. There are four methods of triangulation:

1. data source triangulation: identifies whether a phenomenon occurs or carries the same meaning under different circumstances;

2. investigator triangulation: is achieved by having an independent observer of proceedings, or to present research observations and discuss appropriate interpretations with colleagues;

3. theory triangulation: data are compared by researchers with different theoretical perspectives and where agreement is reached triangulation is achieved. When different meanings are derived from the data, there is an opportunity to enhance understanding of the case; and

4. methodological triangulation: findings are confirmed by following a sequence of methods. In case study the most commonly used methods are observation, interview and document review. Adopting a range of methods can confirm events but it may also uncover an alternative perspective or reading of a situation (Stake 1995, pp112-115).

3.7 Research ethics

Research involving human subjects needs to be conducted in an ethical manner to ensure individuals are not adversely affected by the research (Fowler 2009. p.163). The standards for ethical research practice involve ensuring informed consent, data protection

and privacy (Pauwels 2007). Gaining informed consent from subjects willing to be involved in a research project necessitates that the following points are explained by the researcher and understood by the participant:

• research goals are clearly stated;

• side effects or potentially detrimental factors are transparent;

• gratuities do not act as an inducement to participate in the research; and • participants can withdraw at any time without prejudice (Pauwels 2007, p.20).

To this list Fowler (2009, p.164) added further guiding principles for research surveys involving general populations including:

• making participants aware of the name of the organisation under which the research is being conducted and providing the interviewer’s name;

• notifying subjects of any sponsoring body involved in the research; • stipulating terms of confidentiality; and

• ensuring there are no negative consequences for non-participation.

Data protection and privacy exist to ensure that data sharing does not infringe an individual’s right to privacy. Therefore, researchers are bound to protect identity by coding data during processing and anonymising it to ensure that the connection between an individual and data stored on them are not associated in any traceable way (Pauwels 2007, pp.27-28). Care should be taken when reporting data from small categories of respondents as they might be identifiable. In addition, completed responses should not be available to individuals beyond the project team. It is a researcher’s responsibility to ensure that the completed survey instrument is destroyed, or its continued storage is secure, once the research is completed (Fowler 2009, p.166).

Benefits to participating in research are usually altruistic and inducements should not be excessive so that the principle of voluntary participation is upheld. Researchers should not overstate any benefits and any promises made should be met (Fowler 2009, p.167).

• Website management and development
• Website metrics
• Conclusions
• Literature review (You are here)
• Research samples
• University policy guidance, website management and website template
• Library website governance and staffing
• Methods of website evaluation
• Use of data gathering methods
• Interview results
• Gaps in the survey data

Related documents

Chapter 10. Introduction to Data Collection Techniques

Introduction.

Now that we have discussed various aspects of qualitative research, we can begin to collect data. This chapter serves as a bridge between the first half and second half of this textbook (and perhaps your course) by introducing techniques of data collection. You’ve already been introduced to some of this because qualitative research is often characterized by the form of data collection; for example, an ethnographic study is one that employs primarily observational data collection for the purpose of documenting and presenting a particular culture or ethnos. Thus, some of this chapter will operate as a review of material already covered, but we will be approaching it from the data-collection side rather than the tradition-of-inquiry side we explored in chapters 2 and 4.

Revisiting Approaches

There are four primary techniques of data collection used in qualitative research: interviews, focus groups, observations, and document review. [1] There are other available techniques, such as visual analysis (e.g., photo elicitation) and biography (e.g., autoethnography) that are sometimes used independently or supplementarily to one of the main forms. Not to confuse you unduly, but these various data collection techniques are employed differently by different qualitative research traditions so that sometimes the technique and the tradition become inextricably entwined. This is largely the case with observations and ethnography. The ethnographic tradition is fundamentally based on observational techniques. At the same time, traditions other than ethnography also employ observational techniques, so it is worthwhile thinking of “tradition” and “technique” separately (see figure 10.1).

Figure 10.1. Data Collection Techniques

Each of these data collection techniques will be the subject of its own chapter in the second half of this textbook. This chapter serves as an orienting overview and as the bridge between the conceptual/design portion of qualitative research and the actual practice of conducting qualitative research.

Overview of the Four Primary Approaches

Interviews are at the heart of qualitative research. Returning to epistemological foundations, it is during the interview that the researcher truly opens herself to hearing what others have to say, encouraging her interview subjects to reflect deeply on the meanings and values they hold. Interviews are used in almost every qualitative tradition but are particularly salient in phenomenological studies, studies seeking to understand the meaning of people’s lived experiences.

Focus groups can be seen as a type of interview, one in which a group of persons (ideally between five and twelve) is asked a series of questions focused on a particular topic or subject. They are sometimes used as the primary form of data collection, especially outside academic research. For example, businesses often employ focus groups to determine if a particular product is likely to sell. Among qualitative researchers, it is often used in conjunction with any other primary data collection technique as a form of “triangulation,” or a way of increasing the reliability of the study by getting at the object of study from multiple directions. [2] Some traditions, such as feminist approaches, also see the focus group as an important “consciousness-raising” tool.

If interviews are at the heart of qualitative research, observations are its lifeblood. Researchers who are more interested in the practices and behaviors of people than what they think or who are trying to understand the parameters of an organizational culture rely on observations as their primary form of data collection. The notes they make “in the field” (either during observations or afterward) form the “data” that will be analyzed. Ethnographers, those seeking to describe a particular ethnos, or culture, believe that observations are more reliable guides to that culture than what people have to say about it. Observations are thus the primary form of data collection for ethnographers, albeit often supplemented with in-depth interviews.

Some would say that these three—interviews, focus groups, and observations—are really the foundational techniques of data collection. They are far and away the three techniques most frequently used separately, in conjunction with one another, and even sometimes in mixed methods qualitative/quantitative studies. Document review, either as a form of content analysis or separately, however, is an important addition to the qualitative researcher’s toolkit and should not be overlooked (figure 10.1). Although it is rare for a qualitative researcher to make document review their primary or sole form of data collection, including documents in the research design can help expand the reach and the reliability of a study. Document review can take many forms, from historical and archival research, in which the researcher pieces together a narrative of the past by finding and analyzing a variety of “documents” and records (including photographs and physical artifacts), to analyses of contemporary media content, as in the case of compiling and coding blog posts or other online commentaries, and content analysis that identifies and describes communicative aspects of media or documents.

In addition to these four major techniques, there are a host of emerging and incidental data collection techniques, from photo elicitation or photo voice, in which respondents are asked to comment upon a photograph or image (particularly useful as a supplement to interviews when the respondents are hesitant or unable to answer direct questions), to autoethnographies, in which the researcher uses his own position and life to increase our understanding about a phenomenon and its historical and social context.

Taken together, these techniques provide a wide range of practices and tools with which to discover the world. They are particularly suited to addressing the questions that qualitative researchers ask—questions about how things happen and why people act the way they do, given particular social contexts and shared meanings about the world (chapter 4).

Triangulation and Mixed Methods

Because the researcher plays such a large and nonneutral role in qualitative research, one that requires constant reflectivity and awareness (chapter 6), there is a constant need to reassure her audience that the results she finds are reliable. Quantitative researchers can point to any number of measures of statistical significance to reassure their audiences, but qualitative researchers do not have math to hide behind. And she will also want to reassure herself that what she is hearing in her interviews or observing in the field is a true reflection of what is going on (or as “true” as possible, given the problem that the world is as large and varied as the elephant; see chapter 3). For those reasons, it is common for researchers to employ more than one data collection technique or to include multiple and comparative populations, settings, and samples in the research design (chapter 2). A single set of interviews or initial comparison of focus groups might be conceived as a “pilot study” from which to launch the actual study. Undergraduate students working on a research project might be advised to think about their projects in this way as well. You are simply not going to have enough time or resources as an undergraduate to construct and complete a successful qualitative research project, but you may be able to tackle a pilot study. Graduate students also need to think about the amount of time and resources they have for completing a full study. Masters-level students, or students who have one year or less in which to complete a program, should probably consider their study as an initial exploratory pilot. PhD candidates might have the time and resources to devote to the type of triangulated, multifaceted research design called for by the research question.

We call the use of multiple qualitative methods of data collection and the inclusion of multiple and comparative populations and settings “triangulation.” Using different data collection methods allows us to check the consistency of our findings. For example, a study of the vaccine hesitant might include a set of interviews with vaccine-hesitant people and a focus group of the same and a content analysis of online comments about a vaccine mandate. By employing all three methods, we can be more confident of our interpretations from the interviews alone (especially if we are hearing the same thing throughout; if we are not, then this is a good sign that we need to push a little further to find out what is really going on). [3] Methodological triangulation is an important tool for increasing the reliability of our findings and the overall success of our research.

Methodological triangulation should not be confused with mixed methods techniques, which refer instead to the combining of qualitative and quantitative research methods. Mixed methods studies can increase reliability, but that is not their primary purpose. Mixed methods address multiple research questions, both the “how many” and “why” kind, or the causal and explanatory kind. Mixed methods will be discussed in more detail in chapter 15.

Let us return to the three examples of qualitative research described in chapter 1: Cory Abramson’s study of aging ( The End Game) , Jennifer Pierce’s study of lawyers and discrimination ( Racing for Innocence ), and my own study of liberal arts college students ( Amplified Advantage ). Each of these studies uses triangulation.

Abramson’s book is primarily based on three years of observations in four distinct neighborhoods. He chose the neighborhoods in such a way to maximize his ability to make comparisons: two were primarily middle class and two were primarily poor; further, within each set, one was predominantly White, while the other was either racially diverse or primarily African American. In each neighborhood, he was present in senior centers, doctors’ offices, public transportation, and other public spots where the elderly congregated. [4] The observations are the core of the book, and they are richly written and described in very moving passages. But it wasn’t enough for him to watch the seniors. He also engaged with them in casual conversation. That, too, is part of fieldwork. He sometimes even helped them make it to the doctor’s office or get around town. Going beyond these interactions, he also interviewed sixty seniors, an equal amount from each of the four neighborhoods. It was in the interviews that he could ask more detailed questions about their lives, what they thought about aging, what it meant to them to be considered old, and what their hopes and frustrations were. He could see that those living in the poor neighborhoods had a more difficult time accessing care and resources than those living in the more affluent neighborhoods, but he couldn’t know how the seniors understood these difficulties without interviewing them. Both forms of data collection supported each other and helped make the study richer and more insightful. Interviews alone would have failed to demonstrate the very real differences he observed (and that some seniors would not even have known about). This is the value of methodological triangulation.

Pierce’s book relies on two separate forms of data collection—interviews with lawyers at a firm that has experienced a history of racial discrimination and content analyses of news stories and popular films that screened during the same years of the alleged racial discrimination. I’ve used this book when teaching methods and have often found students struggle with understanding why these two forms of data collection were used. I think this is because we don’t teach students to appreciate or recognize “popular films” as a legitimate form of data. But what Pierce does is interesting and insightful in the best tradition of qualitative research. Here is a description of the content analyses from a review of her book:

In the chapter on the news media, Professor Pierce uses content analysis to argue that the media not only helped shape the meaning of affirmative action, but also helped create white males as a class of victims. The overall narrative that emerged from these media accounts was one of white male innocence and victimization. She also maintains that this narrative was used to support “neoconservative and neoliberal political agendas” (p. 21). The focus of these articles tended to be that affirmative action hurt white working-class and middle-class men particularly during the recession in the 1980s (despite statistical evidence that people of color were hurt far more than white males by the recession). In these stories fairness and innocence were seen in purely individual terms. Although there were stories that supported affirmative action and developed a broader understanding of fairness, the total number of stories slanted against affirmative action from 1990 to 1999. During that time period negative stories always outnumbered those supporting the policy, usually by a ratio of 3:1 or 3:2. Headlines, the presentation of polling data, and an emphasis in stories on racial division, Pierce argues, reinforced the story of white male victimization. Interestingly, the news media did very few stories on gender and affirmative action. The chapter on the film industry from 1989 to 1999 reinforces Pierce’s argument and adds another layer to her interpretation of affirmative action during this time period. She sampled almost 60 Hollywood films with receipts ranging from four million to 184 million dollars. In this chapter she argues that the dominant theme of these films was racial progress and the redemption of white Americans from past racism. These movies usually portrayed white, elite, and male experiences. People of color were background figures who supported the protagonist and “anointed” him as a savior (p. 45). Over the course of the film the protagonists move from “innocence to consciousness” concerning racism. The antagonists in these films most often were racist working-class white men. A Time to Kill , Mississippi Burning , Amistad , Ghosts of Mississippi , The Long Walk Home , To Kill a Mockingbird , and Dances with Wolves receive particular analysis in this chapter, and her examination of them leads Pierce to conclude that they infused a myth of racial progress into America’s cultural memory. White experiences of race are the focus and contemporary forms of racism are underplayed or omitted. Further, these films stereotype both working-class and elite white males, and underscore the neoliberal emphasis on individualism. ( Hrezo 2012 )

With that context in place, Pierce then turned to interviews with attorneys. She finds that White male attorneys often misremembered facts about the period in which the law firm was accused of racial discrimination and that they often portrayed their firms as having made substantial racial progress. This was in contrast to many of the lawyers of color and female lawyers who remembered the history differently and who saw continuing examples of racial (and gender) discrimination at the law firm. In most of the interviews, people talked about individuals, not structure (and these are attorneys, who really should know better!). By including both content analyses and interviews in her study, Pierce is better able to situate the attorney narratives and explain the larger context for the shared meanings of individual innocence and racial progress. Had this been a study only of films during this period, we would not know how actual people who lived during this period understood the decisions they made; had we had only the interviews, we would have missed the historical context and seen a lot of these interviewees as, well, not very nice people at all. Together, we have a study that is original, inventive, and insightful.

My own study of how class background affects the experiences and outcomes of students at small liberal arts colleges relies on mixed methods and triangulation. At the core of the book is an original survey of college students across the US. From analyses of this survey, I can present findings on “how many” questions and descriptive statistics comparing students of different social class backgrounds. For example, I know and can demonstrate that working-class college students are less likely to go to graduate school after college than upper-class college students are. I can even give you some estimates of the class gap. But what I can’t tell you from the survey is exactly why this is so or how it came to be so . For that, I employ interviews, focus groups, document reviews, and observations. Basically, I threw the kitchen sink at the “problem” of class reproduction and higher education (i.e., Does college reduce class inequalities or make them worse?). A review of historical documents provides a picture of the place of the small liberal arts college in the broader social and historical context. Who had access to these colleges and for what purpose have always been in contest, with some groups attempting to exclude others from opportunities for advancement. What it means to choose a small liberal arts college in the early twenty-first century is thus different for those whose parents are college professors, for those whose parents have a great deal of money, and for those who are the first in their family to attend college. I was able to get at these different understandings through interviews and focus groups and to further delineate the culture of these colleges by careful observation (and my own participation in them, as both former student and current professor). Putting together individual meanings, student dispositions, organizational culture, and historical context allowed me to present a story of how exactly colleges can both help advance first-generation, low-income, working-class college students and simultaneously amplify the preexisting advantages of their peers. Mixed methods addressed multiple research questions, while triangulation allowed for this deeper, more complex story to emerge.

In the next few chapters, we will explore each of the primary data collection techniques in much more detail. As we do so, think about how these techniques may be productively joined for more reliable and deeper studies of the social world.

Advanced Reading: Triangulation

Denzin ( 1978 ) identified four basic types of triangulation: data, investigator, theory, and methodological. Properly speaking, if we use the Denzin typology, the use of multiple methods of data collection and analysis to strengthen one’s study is really a form of methodological triangulation. It may be helpful to understand how this differs from the other types.

Data triangulation occurs when the researcher uses a variety of sources in a single study. Perhaps they are interviewing multiple samples of college students. Obviously, this overlaps with sample selection (see chapter 5). It is helpful for the researcher to understand that these multiple data sources add strength and reliability to the study. After all, it is not just “these students here” but also “those students over there” that are experiencing this phenomenon in a particular way.

Investigator triangulation occurs when different researchers or evaluators are part of the research team. Intercoding reliability is a form of investigator triangulation (or at least a way of leveraging the power of multiple researchers to raise the reliability of the study).

Theory triangulation is the use of multiple perspectives to interpret a single set of data, as in the case of competing theoretical paradigms (e.g., a human capital approach vs. a Bourdieusian multiple capital approach).

Methodological triangulation , as explained in this chapter, is the use of multiple methods to study a single phenomenon, issue, or problem.

Further Readings

Carter, Nancy, Denise Bryant-Lukosius, Alba DiCenso, Jennifer Blythe, Alan J. Neville. 2014. “The Use of Triangulation in Qualitative Research.” Oncology Nursing Forum 41(5):545–547. Discusses the four types of triangulation identified by Denzin with an example of the use of focus groups and in-depth individuals.

Mathison, Sandra. 1988. “Why Triangulate?” Educational Researcher 17(2):13–17. Presents three particular ways of assessing validity through the use of triangulated data collection: convergence, inconsistency, and contradiction.

Tracy, Sarah J. 2010. “Qualitative Quality: Eight ‘Big-Tent’ Criteria for Excellent Qualitative Research.” Qualitative Inquiry 16(10):837–851. Focuses on triangulation as a criterion for conducting valid qualitative research.

• Marshall and Rossman ( 2016 ) state this slightly differently. They list four primary methods for gathering information: (1) participating in the setting, (2) observing directly, (3) interviewing in depth, and (4) analyzing documents and material culture (141). An astute reader will note that I have collapsed participation into observation and that I have distinguished focus groups from interviews. I suspect that this distinction marks me as more of an interview-based researcher, while Marshall and Rossman prioritize ethnographic approaches. The main point of this footnote is to show you, the reader, that there is no single agreed-upon number of approaches to collecting qualitative data. ↵
• See “ Advanced Reading: Triangulation ” at end of this chapter. ↵
• We can also think about triangulating the sources, as when we include comparison groups in our sample (e.g., if we include those receiving vaccines, we might find out a bit more about where the real differences lie between them and the vaccine hesitant); triangulating the analysts (building a research team so that your interpretations can be checked against those of others on the team); and even triangulating the theoretical perspective (as when we “try on,” say, different conceptualizations of social capital in our analyses). ↵

Introduction to Qualitative Research Methods Copyright © 2023 by Allison Hurst is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License , except where otherwise noted.

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• Published: 09 April 2024

The potential for artificial intelligence to transform healthcare: perspectives from international health leaders

• Christina Silcox 1 ,
• Eyal Zimlichmann 2 , 3 ,
• Katie Huber   ORCID: orcid.org/0000-0003-2519-8714 1 ,
• Neil Rowen 1 ,
• Robert Saunders 1 ,
• Mark McClellan 1 ,
• Charles N. Kahn III 3 , 4 ,
• Claudia A. Salzberg 3 &
• David W. Bates   ORCID: orcid.org/0000-0001-6268-1540 5 , 6 , 7  

npj Digital Medicine volume  7 , Article number:  88 ( 2024 ) Cite this article

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Artificial intelligence (AI) has the potential to transform care delivery by improving health outcomes, patient safety, and the affordability and accessibility of high-quality care. AI will be critical to building an infrastructure capable of caring for an increasingly aging population, utilizing an ever-increasing knowledge of disease and options for precision treatments, and combatting workforce shortages and burnout of medical professionals. However, we are not currently on track to create this future. This is in part because the health data needed to train, test, use, and surveil these tools are generally neither standardized nor accessible. There is also universal concern about the ability to monitor health AI tools for changes in performance as they are implemented in new places, used with diverse populations, and over time as health data may change. The Future of Health (FOH), an international community of senior health care leaders, collaborated with the Duke-Margolis Institute for Health Policy to conduct a literature review, expert convening, and consensus-building exercise around this topic. This commentary summarizes the four priority action areas and recommendations for health care organizations and policymakers across the globe that FOH members identified as important for fully realizing AI’s potential in health care: improving data quality to power AI, building infrastructure to encourage efficient and trustworthy development and evaluations, sharing data for better AI, and providing incentives to accelerate the progress and impact of AI.

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Introduction

Artificial intelligence (AI), supported by timely and accurate data and evidence, has the potential to transform health care delivery by improving health outcomes, patient safety, and the affordability and accessibility of high-quality care 1 , 2 . AI integration is critical to building an infrastructure capable of caring for an increasingly aging population, utilizing an ever-increasing knowledge of disease and options for precision treatments, and combatting workforce shortages and burnout of medical professionals. However, we are not currently on track to create this future. This is in part because the health data needed to train, test, use, and surveil these tools are generally neither standardized nor accessible. This is true across the international community, although there is variable progress within individual countries. There is also universal concern about monitoring health AI tools for changes in performance as they are implemented in new places, used with diverse populations, and over time as health data may change.

The Future of Health (FOH) is an international community of senior health care leaders representing health systems, health policy, health care technology, venture funding, insurance, and risk management. FOH collaborated with the Duke-Margolis Institute for Health Policy to conduct a literature review, expert convening, and consensus-building exercise. In total, 46 senior health care leaders were engaged in this work, from eleven countries in Europe, North America, Africa, Asia, and Australia. This commentary summarizes the four priority action areas and recommendations for health care organizations and policymakers that FOH members identified as important for fully realizing AI’s potential in health care: improving data quality to power AI, building infrastructure to encourage efficient and trustworthy development and evaluations, sharing data for better AI, and providing incentives to accelerate the progress and impact of AI.

Powering AI through high-quality data

“Going forward, data are going to be the most valuable commodity in health care. Organizations need robust plans about how to mobilize and use their data.”

AI algorithms will only perform as well as the accuracy and completeness of key underlying data, and data quality is dependent on actions and workflows that encourage trust.

To begin to improve data quality, FOH members agreed that an initial priority is identifying and assuring reliable availability of high-priority data elements for promising AI applications: those with the most predictive value, those of the highest value to patients, and those most important for analyses of performance, including subgroup analyses to detect bias.

Leaders should also advocate for aligned policy incentives to improve the availability and reliability of these priority data elements. There are several examples of efforts across the world to identify and standardize high-priority data elements for AI applications and beyond, such as the multinational project STANDING Together, which is developing standards to improve the quality and representativeness of data used to build and test AI tools 3 .

Policy incentives that would further encourage high-quality data collection include (1) aligned payment incentives for measures of health care quality and safety, and ensuring the reliability of the underlying data, and (2) quality measures and performance standards focused on the reliability, completeness, and timeliness of collection and sharing of high-priority data itself.

Trust and verify

“Your AI algorithms are only going to be as good as the data and the real-world evidence used to validate them, and the data are only going to be as good as the trust and privacy and supporting policies.”

FOH members stressed the importance of showing that AI tools are both effective and safe within their specific patient populations.

This is a particular challenge with AI tools, whose performance can differ dramatically across sites and over time, as health data patterns and population characteristics vary. For example, several studies of the Epic Sepsis Model found both location-based differences in performance and degradation in performance over time due to data drift 4 , 5 . However, real-world evaluations are often much more difficult for algorithms that are used for longer-term predictions, or to avert long-term complications from occurring, particularly in the absence of connected, longitudinal data infrastructure. As such, health systems must prioritize implementing data standards and data infrastructure that can facilitate the retraining or tuning of algorithms, test for local performance and bias, and ensure scalability across the organization and longer-term applications 6 .

There are efforts to help leaders and health systems develop consensus-based evaluation techniques and infrastructure for AI tools, including HealthAI: The Global Agency for Responsible AI in Health, which aims to build and certify validation mechanisms for nations and regions to adopt; and the Coalition for Health AI (CHAI), which recently announced plans to build a US-wide health AI assurance labs network 7 , 8 . These efforts, if successful, will assist manufacturers and health systems in complying with new laws, rules, and regulations being proposed and released that seek to ensure AI tools are trustworthy, such as the EU AI Act and the 2023 US Executive Order on AI.

Sharing data for better AI

“Underlying these challenges is the investment required to standardize business processes so that you actually get data that’s usable between institutions and even within an institution.”

While high-quality internal data may enable some types of AI-tool development and testing, this is insufficient to power and evaluate all AI applications. To build truly effective AI-enabled predictive software for clinical care and predictive supports, data often need to be interoperable across health systems to build a diverse picture of patients’ health across geographies, and reliably shared.

FOH members recommended that health care leaders work with researchers and policymakers to connect detailed encounter data with longitudinal outcomes, and pilot opportunities across diverse populations and systems to help assure valid outcome evaluations as well as address potential confounding and population subgroup differences—the ability to aggregate data is a clear rate-limiting step. The South African National Digital Health Strategy outlined interventions to improve the adoption of digital technologies while complying with the 2013 Protection of Personal Information Act 9 . Although challenges remain, the country has made progress on multiple fronts, including building out a Health Patient Registration System as a first step towards a portable, longitudinal patient record system and releasing a Health Normative Standards Framework to improve data flow across institutional and geographic boundaries 10 .

Leaders should adopt policies in their organizations, and encourage adoption in their province and country, that simplify data governance and sharing while providing appropriate privacy protections – including building foundations of trust with patients and the public as previously discussed. Privacy-preserving innovations include ways to “share” data without movement from protected systems using approaches like federated analyses, data sandboxes, or synthetic data. In addition to exploring privacy-preserving approaches to data sharing, countries and health systems may need to consider broad and dynamic approaches to consent 11 , 12 . As we look to a future where a patient may have thousands of algorithms churning away at their data, efforts to improve data quality and sharing should include enabling patients’ access to and engagement with their own data to encourage them to actively partner in their health and provide transparency on how their data are being used to improve health care. For example, the Understanding Patient Data program in the United Kingdom produces research and resources to explain how the National Health Service uses patients’ data 13 . Community engagement efforts can further assist with these efforts by building trust and expanding understanding.

FOH members also stressed the importance of timely data access. Health systems should work together to establish re-usable governance and privacy frameworks that allow stakeholders to clearly understand what data will be shared and how it will be protected to reduce the time needed for data use agreements. Trusted third-party data coordinating centers could also be used to set up “precertification” systems around data quality, testing, and cybersecurity to support health organizations with appropriate data stewardship to form partnerships and access data rapidly.

Incentivizing progress for AI impact

“Unless it’s tied to some kind of compensation to the organization, the drive to help implement those tools and overcome that risk aversion is going to be very high… I do think that business driver needs to be there.”

AI tools and data quality initiatives have not moved as quickly in health care due to the lack of direct payment, and often, misalignment of financial incentives and supports for high-quality data collection and predictive analytics. This affects both the ability to purchase and safely implement commercial AI products as well as the development of “homegrown” AI tools.

FOH members recommended that leaders should advocate for paying for value in health – quality, safety, better health, and lower costs for patients. This better aligns the financial incentives for accelerating the development, evaluation, and adoption of AI as well as other tools designed to either keep patients healthy or quickly diagnose and treat them with the most effective therapies when they do become ill. Effective personalized health care requires high-quality, standardized, interoperable datasets from diverse sources 14 . Within value-based payments themselves, data are critical to measuring quality of care and patient outcomes, adjusted or contextualized for factors outside of clinical control. Value-based payments therefore align incentives for (1) high-quality data collection and trusted use, (2) building effective AI tools, and (3) ensuring that those tools are improving patient outcomes and/or health system operations.

Data have become the most valuable commodity in health care, but questions remain about whether there will be an AI “revolution” or “evolution” in health care delivery. Early AI applications in certain clinical areas have been promising, but more advanced AI tools will require higher quality, real-world data that is interoperable and secure. The steps health care organization leaders and policymakers take in the coming years, starting with short-term opportunities to develop meaningful AI applications that achieve measurable improvements in outcomes and costs, will be critical in enabling this future that can improve health outcomes, safety, affordability, and equity.

Data availability

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

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Acknowledgements

The authors acknowledge Oranit Ido and Jonathan Gonzalez-Smith for their contributions to this work. This study was funded by The Future of Health, LLC. The Future of Health, LLC, was involved in all stages of this research, including study design, data collection, analysis and interpretation of data, and the preparation of this manuscript.

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Eyal Zimlichmann, Charles N. Kahn III & Claudia A. Salzberg

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Contributions

C.S., K.H., N.R., and R.S. conducted initial background research and analyzed qualitative data from stakeholders. All authors (C.S., E.Z., K.H., N.R., R.S., M.M., C.K., C.A.S., and D.B.) assisted with conceptualization of the project and strategic guidance. C.S., K.H., and N.R. wrote initial drafts of the manuscript. All authors contributed to critical revisions of the manuscript and read and approved the final manuscript.

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Correspondence to David W. Bates .

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C.S., K.H., N.R., and C.A.S. declare no competing interests. E.Z. reports personal fees from Arkin Holdings, personal fees from Statista and equity from Valera Health, Profility and Hello Heart. R.S. has been an external reviewer for The John A. Hartford Foundation, and is a co-chair for the Health Evolution Summit Roundtable on Value-Based Care for Specialized Populations. M.M. is an independent director on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and reports fees for serving as an adviser for Arsenal Capital Partners, Blackstone Life Sciences, and MITRE. C.K. is a Profility Board member and additionally reports equity from Valera Health and MDClone. D.W.B. reports grants and personal fees from EarlySense, personal fees from CDI Negev, equity from Valera Health, equity from Clew, equity from MDClone, personal fees and equity from AESOP, personal fees and equity from Feelbetter, equity from Guided Clinical Solutions, and grants from IBM Watson Health, outside the submitted work. D.W.B. has a patent pending (PHC-028564 US PCT), on intraoperative clinical decision support.

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Silcox, C., Zimlichmann, E., Huber, K. et al. The potential for artificial intelligence to transform healthcare: perspectives from international health leaders. npj Digit. Med. 7 , 88 (2024). https://doi.org/10.1038/s41746-024-01097-6

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This article is part of the research topic.

Embryo Development and Selection: Advances in Genetics

Editorial: Embryo Development and Selection: Advances in Genetics Provisionally Accepted

• 1 Guilin Medical University, China
• 2 Hainan Medical University, China

The final, formatted version of the article will be published soon.

Assisted reproductive technologies (ART) are being utilized with increasing frequency across the globe to support individuals who face challenges in conceiving naturally. ART procedures facilitate pregnancy by extracting eggs from a woman's ovaries, fusing them with sperm in a laboratory setting, and subsequently reintroducing them into the woman's body. The efficacy of ART is subject to a multitude of factors, encompassing genetic considerations, historical medical and reproductive data, the specific medications employed during ART treatment, and any complications that may arise during pregnancy. The focus of this research topic is the selection of embryos during the ART process, and an exploration of the factors that influence embryo development and the overall success rate of ART. 1. Abu et al. evaluated the impact of supplementing a single-dose GnRH agonist to the standard progestogen regimen for luteal phase support in IVF treatments. Compared to using progestogens alone, they found that adding a GnRH agonist improved the overall IVF outcomes.2. Andreescu has conducted a review on the dysregulation of immune responses between the mother and fetus, a factor that heightens the risk of embryo rejection and reproductive failure.This paper provides an exhaustive overview of the current literature on the influence of Calcineurin inhibitors and anti-TNF treatment in enhancing the live birth rate post embryo transfer. It concludes that the suppression of immunological rejection and the promotion of immunological tolerance are vital in safeguarding embryos and averting immunological assaults. Therefore, it is important to exercise caution while selecting use of any immunosuppressive therapy in pregnancy. indicates that the risks associated with angular pregnancy following ART may not be as severe as previously thought. With regular, close monitoring, the majority of these cases can be managed expectantly, often resulting in live births. 5. Zhu and colleagues conducted a study to identify the risk factors that influence the occurrence of heterotopic pregnancies following IVF-ET. They also examined the outcomes of pregnancies after surgical intervention for heterotopic pregnancies. Their research indicates that a history of ectopic pregnancy, multiple abortions, tubal infertility, and multiple-embryo transfer may significantly increase the risk of a subsequent heterotopic pregnancy after IVF-ET.The study also found that for patients with heterotopic pregnancies who undergo surgery, factors such as a shorter operation duration, a smaller ectopic mass, and a location in the ampulla of the fallopian tube are associated with a more favorable reproductive prognosis. IVF success rates are influenced by a multitude of factors, including genetic considerations, historical medical and reproductive data, the types of medications used during ART treatment, and complications that may arise during pregnancy. The research papers discussed here offer significant insights into improving the success rates of IVF. They underscore the efficacy of a combined treatment approach using N-Acetylcysteine and Gonadotropins, which has been shown to enhance ovarian response to superovulation drugs and improve the quality of blastocysts in older women. The papers also identify surgical time, the size of ectopic masses, and their location in the ampulla of the fallopian tube as key factors in determining the reproductive prognosis in patients with ectopic pregnancies. Additionally, the use of GnRH agonists in the luteal phase has been found to increase IVF success rates. The papers also discuss the evaluation of cornual pregnancy following ART. The aim of these studies is to reduce the risks associated with assisted reproduction and increase pregnancy rates, thereby providing invaluable information for clinical IVF centers. The referenced studies investigate the influence of several factors on the success rate of IVF. These factors encompass the patient's medical history, the treatment protocol, the medications administered during treatment, and complications encountered during pregnancy.The insights and research outcomes presented are of immense value for improving the success rates of assisted reproductive techniques.

Keywords: assisted reproductive technologies, Pregnancy rates, Embryo development, Embryo selection, Influence factor

Received: 13 Apr 2024; Accepted: 22 Apr 2024.

Copyright: © 2024 Liu and Ma. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Mx. Yanlin Ma, Hainan Medical University, Haikou, 571199, Hainan Province, China

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Qualitative Research: Data Collection, Analysis, and Management

Introduction.

In an earlier paper, 1 we presented an introduction to using qualitative research methods in pharmacy practice. In this article, we review some principles of the collection, analysis, and management of qualitative data to help pharmacists interested in doing research in their practice to continue their learning in this area. Qualitative research can help researchers to access the thoughts and feelings of research participants, which can enable development of an understanding of the meaning that people ascribe to their experiences. Whereas quantitative research methods can be used to determine how many people undertake particular behaviours, qualitative methods can help researchers to understand how and why such behaviours take place. Within the context of pharmacy practice research, qualitative approaches have been used to examine a diverse array of topics, including the perceptions of key stakeholders regarding prescribing by pharmacists and the postgraduation employment experiences of young pharmacists (see “Further Reading” section at the end of this article).

In the previous paper, 1 we outlined 3 commonly used methodologies: ethnography 2 , grounded theory 3 , and phenomenology. 4 Briefly, ethnography involves researchers using direct observation to study participants in their “real life” environment, sometimes over extended periods. Grounded theory and its later modified versions (e.g., Strauss and Corbin 5 ) use face-to-face interviews and interactions such as focus groups to explore a particular research phenomenon and may help in clarifying a less-well-understood problem, situation, or context. Phenomenology shares some features with grounded theory (such as an exploration of participants’ behaviour) and uses similar techniques to collect data, but it focuses on understanding how human beings experience their world. It gives researchers the opportunity to put themselves in another person’s shoes and to understand the subjective experiences of participants. 6 Some researchers use qualitative methodologies but adopt a different standpoint, and an example of this appears in the work of Thurston and others, 7 discussed later in this paper.

Qualitative work requires reflection on the part of researchers, both before and during the research process, as a way of providing context and understanding for readers. When being reflexive, researchers should not try to simply ignore or avoid their own biases (as this would likely be impossible); instead, reflexivity requires researchers to reflect upon and clearly articulate their position and subjectivities (world view, perspectives, biases), so that readers can better understand the filters through which questions were asked, data were gathered and analyzed, and findings were reported. From this perspective, bias and subjectivity are not inherently negative but they are unavoidable; as a result, it is best that they be articulated up-front in a manner that is clear and coherent for readers.

THE PARTICIPANT’S VIEWPOINT

What qualitative study seeks to convey is why people have thoughts and feelings that might affect the way they behave. Such study may occur in any number of contexts, but here, we focus on pharmacy practice and the way people behave with regard to medicines use (e.g., to understand patients’ reasons for nonadherence with medication therapy or to explore physicians’ resistance to pharmacists’ clinical suggestions). As we suggested in our earlier article, 1 an important point about qualitative research is that there is no attempt to generalize the findings to a wider population. Qualitative research is used to gain insights into people’s feelings and thoughts, which may provide the basis for a future stand-alone qualitative study or may help researchers to map out survey instruments for use in a quantitative study. It is also possible to use different types of research in the same study, an approach known as “mixed methods” research, and further reading on this topic may be found at the end of this paper.

The role of the researcher in qualitative research is to attempt to access the thoughts and feelings of study participants. This is not an easy task, as it involves asking people to talk about things that may be very personal to them. Sometimes the experiences being explored are fresh in the participant’s mind, whereas on other occasions reliving past experiences may be difficult. However the data are being collected, a primary responsibility of the researcher is to safeguard participants and their data. Mechanisms for such safeguarding must be clearly articulated to participants and must be approved by a relevant research ethics review board before the research begins. Researchers and practitioners new to qualitative research should seek advice from an experienced qualitative researcher before embarking on their project.

DATA COLLECTION

Whatever philosophical standpoint the researcher is taking and whatever the data collection method (e.g., focus group, one-to-one interviews), the process will involve the generation of large amounts of data. In addition to the variety of study methodologies available, there are also different ways of making a record of what is said and done during an interview or focus group, such as taking handwritten notes or video-recording. If the researcher is audio- or video-recording data collection, then the recordings must be transcribed verbatim before data analysis can begin. As a rough guide, it can take an experienced researcher/transcriber 8 hours to transcribe one 45-minute audio-recorded interview, a process than will generate 20–30 pages of written dialogue.

Many researchers will also maintain a folder of “field notes” to complement audio-taped interviews. Field notes allow the researcher to maintain and comment upon impressions, environmental contexts, behaviours, and nonverbal cues that may not be adequately captured through the audio-recording; they are typically handwritten in a small notebook at the same time the interview takes place. Field notes can provide important context to the interpretation of audio-taped data and can help remind the researcher of situational factors that may be important during data analysis. Such notes need not be formal, but they should be maintained and secured in a similar manner to audio tapes and transcripts, as they contain sensitive information and are relevant to the research. For more information about collecting qualitative data, please see the “Further Reading” section at the end of this paper.

DATA ANALYSIS AND MANAGEMENT

If, as suggested earlier, doing qualitative research is about putting oneself in another person’s shoes and seeing the world from that person’s perspective, the most important part of data analysis and management is to be true to the participants. It is their voices that the researcher is trying to hear, so that they can be interpreted and reported on for others to read and learn from. To illustrate this point, consider the anonymized transcript excerpt presented in Appendix 1 , which is taken from a research interview conducted by one of the authors (J.S.). We refer to this excerpt throughout the remainder of this paper to illustrate how data can be managed, analyzed, and presented.

Interpretation of Data

Interpretation of the data will depend on the theoretical standpoint taken by researchers. For example, the title of the research report by Thurston and others, 7 “Discordant indigenous and provider frames explain challenges in improving access to arthritis care: a qualitative study using constructivist grounded theory,” indicates at least 2 theoretical standpoints. The first is the culture of the indigenous population of Canada and the place of this population in society, and the second is the social constructivist theory used in the constructivist grounded theory method. With regard to the first standpoint, it can be surmised that, to have decided to conduct the research, the researchers must have felt that there was anecdotal evidence of differences in access to arthritis care for patients from indigenous and non-indigenous backgrounds. With regard to the second standpoint, it can be surmised that the researchers used social constructivist theory because it assumes that behaviour is socially constructed; in other words, people do things because of the expectations of those in their personal world or in the wider society in which they live. (Please see the “Further Reading” section for resources providing more information about social constructivist theory and reflexivity.) Thus, these 2 standpoints (and there may have been others relevant to the research of Thurston and others 7 ) will have affected the way in which these researchers interpreted the experiences of the indigenous population participants and those providing their care. Another standpoint is feminist standpoint theory which, among other things, focuses on marginalized groups in society. Such theories are helpful to researchers, as they enable us to think about things from a different perspective. Being aware of the standpoints you are taking in your own research is one of the foundations of qualitative work. Without such awareness, it is easy to slip into interpreting other people’s narratives from your own viewpoint, rather than that of the participants.

To analyze the example in Appendix 1 , we will adopt a phenomenological approach because we want to understand how the participant experienced the illness and we want to try to see the experience from that person’s perspective. It is important for the researcher to reflect upon and articulate his or her starting point for such analysis; for example, in the example, the coder could reflect upon her own experience as a female of a majority ethnocultural group who has lived within middle class and upper middle class settings. This personal history therefore forms the filter through which the data will be examined. This filter does not diminish the quality or significance of the analysis, since every researcher has his or her own filters; however, by explicitly stating and acknowledging what these filters are, the researcher makes it easer for readers to contextualize the work.

Transcribing and Checking

For the purposes of this paper it is assumed that interviews or focus groups have been audio-recorded. As mentioned above, transcribing is an arduous process, even for the most experienced transcribers, but it must be done to convert the spoken word to the written word to facilitate analysis. For anyone new to conducting qualitative research, it is beneficial to transcribe at least one interview and one focus group. It is only by doing this that researchers realize how difficult the task is, and this realization affects their expectations when asking others to transcribe. If the research project has sufficient funding, then a professional transcriber can be hired to do the work. If this is the case, then it is a good idea to sit down with the transcriber, if possible, and talk through the research and what the participants were talking about. This background knowledge for the transcriber is especially important in research in which people are using jargon or medical terms (as in pharmacy practice). Involving your transcriber in this way makes the work both easier and more rewarding, as he or she will feel part of the team. Transcription editing software is also available, but it is expensive. For example, ELAN (more formally known as EUDICO Linguistic Annotator, developed at the Technical University of Berlin) 8 is a tool that can help keep data organized by linking media and data files (particularly valuable if, for example, video-taping of interviews is complemented by transcriptions). It can also be helpful in searching complex data sets. Products such as ELAN do not actually automatically transcribe interviews or complete analyses, and they do require some time and effort to learn; nonetheless, for some research applications, it may be a valuable to consider such software tools.

All audio recordings should be transcribed verbatim, regardless of how intelligible the transcript may be when it is read back. Lines of text should be numbered. Once the transcription is complete, the researcher should read it while listening to the recording and do the following: correct any spelling or other errors; anonymize the transcript so that the participant cannot be identified from anything that is said (e.g., names, places, significant events); insert notations for pauses, laughter, looks of discomfort; insert any punctuation, such as commas and full stops (periods) (see Appendix 1 for examples of inserted punctuation), and include any other contextual information that might have affected the participant (e.g., temperature or comfort of the room).

Dealing with the transcription of a focus group is slightly more difficult, as multiple voices are involved. One way of transcribing such data is to “tag” each voice (e.g., Voice A, Voice B). In addition, the focus group will usually have 2 facilitators, whose respective roles will help in making sense of the data. While one facilitator guides participants through the topic, the other can make notes about context and group dynamics. More information about group dynamics and focus groups can be found in resources listed in the “Further Reading” section.

Reading between the Lines

During the process outlined above, the researcher can begin to get a feel for the participant’s experience of the phenomenon in question and can start to think about things that could be pursued in subsequent interviews or focus groups (if appropriate). In this way, one participant’s narrative informs the next, and the researcher can continue to interview until nothing new is being heard or, as it says in the text books, “saturation is reached”. While continuing with the processes of coding and theming (described in the next 2 sections), it is important to consider not just what the person is saying but also what they are not saying. For example, is a lengthy pause an indication that the participant is finding the subject difficult, or is the person simply deciding what to say? The aim of the whole process from data collection to presentation is to tell the participants’ stories using exemplars from their own narratives, thus grounding the research findings in the participants’ lived experiences.

Smith 9 suggested a qualitative research method known as interpretative phenomenological analysis, which has 2 basic tenets: first, that it is rooted in phenomenology, attempting to understand the meaning that individuals ascribe to their lived experiences, and second, that the researcher must attempt to interpret this meaning in the context of the research. That the researcher has some knowledge and expertise in the subject of the research means that he or she can have considerable scope in interpreting the participant’s experiences. Larkin and others 10 discussed the importance of not just providing a description of what participants say. Rather, interpretative phenomenological analysis is about getting underneath what a person is saying to try to truly understand the world from his or her perspective.

Once all of the research interviews have been transcribed and checked, it is time to begin coding. Field notes compiled during an interview can be a useful complementary source of information to facilitate this process, as the gap in time between an interview, transcribing, and coding can result in memory bias regarding nonverbal or environmental context issues that may affect interpretation of data.

Coding refers to the identification of topics, issues, similarities, and differences that are revealed through the participants’ narratives and interpreted by the researcher. This process enables the researcher to begin to understand the world from each participant’s perspective. Coding can be done by hand on a hard copy of the transcript, by making notes in the margin or by highlighting and naming sections of text. More commonly, researchers use qualitative research software (e.g., NVivo, QSR International Pty Ltd; www.qsrinternational.com/products_nvivo.aspx ) to help manage their transcriptions. It is advised that researchers undertake a formal course in the use of such software or seek supervision from a researcher experienced in these tools.

Returning to Appendix 1 and reading from lines 8–11, a code for this section might be “diagnosis of mental health condition”, but this would just be a description of what the participant is talking about at that point. If we read a little more deeply, we can ask ourselves how the participant might have come to feel that the doctor assumed he or she was aware of the diagnosis or indeed that they had only just been told the diagnosis. There are a number of pauses in the narrative that might suggest the participant is finding it difficult to recall that experience. Later in the text, the participant says “nobody asked me any questions about my life” (line 19). This could be coded simply as “health care professionals’ consultation skills”, but that would not reflect how the participant must have felt never to be asked anything about his or her personal life, about the participant as a human being. At the end of this excerpt, the participant just trails off, recalling that no-one showed any interest, which makes for very moving reading. For practitioners in pharmacy, it might also be pertinent to explore the participant’s experience of akathisia and why this was left untreated for 20 years.

One of the questions that arises about qualitative research relates to the reliability of the interpretation and representation of the participants’ narratives. There are no statistical tests that can be used to check reliability and validity as there are in quantitative research. However, work by Lincoln and Guba 11 suggests that there are other ways to “establish confidence in the ‘truth’ of the findings” (p. 218). They call this confidence “trustworthiness” and suggest that there are 4 criteria of trustworthiness: credibility (confidence in the “truth” of the findings), transferability (showing that the findings have applicability in other contexts), dependability (showing that the findings are consistent and could be repeated), and confirmability (the extent to which the findings of a study are shaped by the respondents and not researcher bias, motivation, or interest).

One way of establishing the “credibility” of the coding is to ask another researcher to code the same transcript and then to discuss any similarities and differences in the 2 resulting sets of codes. This simple act can result in revisions to the codes and can help to clarify and confirm the research findings.

Theming refers to the drawing together of codes from one or more transcripts to present the findings of qualitative research in a coherent and meaningful way. For example, there may be examples across participants’ narratives of the way in which they were treated in hospital, such as “not being listened to” or “lack of interest in personal experiences” (see Appendix 1 ). These may be drawn together as a theme running through the narratives that could be named “the patient’s experience of hospital care”. The importance of going through this process is that at its conclusion, it will be possible to present the data from the interviews using quotations from the individual transcripts to illustrate the source of the researchers’ interpretations. Thus, when the findings are organized for presentation, each theme can become the heading of a section in the report or presentation. Underneath each theme will be the codes, examples from the transcripts, and the researcher’s own interpretation of what the themes mean. Implications for real life (e.g., the treatment of people with chronic mental health problems) should also be given.

DATA SYNTHESIS

In this final section of this paper, we describe some ways of drawing together or “synthesizing” research findings to represent, as faithfully as possible, the meaning that participants ascribe to their life experiences. This synthesis is the aim of the final stage of qualitative research. For most readers, the synthesis of data presented by the researcher is of crucial significance—this is usually where “the story” of the participants can be distilled, summarized, and told in a manner that is both respectful to those participants and meaningful to readers. There are a number of ways in which researchers can synthesize and present their findings, but any conclusions drawn by the researchers must be supported by direct quotations from the participants. In this way, it is made clear to the reader that the themes under discussion have emerged from the participants’ interviews and not the mind of the researcher. The work of Latif and others 12 gives an example of how qualitative research findings might be presented.

Planning and Writing the Report

As has been suggested above, if researchers code and theme their material appropriately, they will naturally find the headings for sections of their report. Qualitative researchers tend to report “findings” rather than “results”, as the latter term typically implies that the data have come from a quantitative source. The final presentation of the research will usually be in the form of a report or a paper and so should follow accepted academic guidelines. In particular, the article should begin with an introduction, including a literature review and rationale for the research. There should be a section on the chosen methodology and a brief discussion about why qualitative methodology was most appropriate for the study question and why one particular methodology (e.g., interpretative phenomenological analysis rather than grounded theory) was selected to guide the research. The method itself should then be described, including ethics approval, choice of participants, mode of recruitment, and method of data collection (e.g., semistructured interviews or focus groups), followed by the research findings, which will be the main body of the report or paper. The findings should be written as if a story is being told; as such, it is not necessary to have a lengthy discussion section at the end. This is because much of the discussion will take place around the participants’ quotes, such that all that is needed to close the report or paper is a summary, limitations of the research, and the implications that the research has for practice. As stated earlier, it is not the intention of qualitative research to allow the findings to be generalized, and therefore this is not, in itself, a limitation.

Planning out the way that findings are to be presented is helpful. It is useful to insert the headings of the sections (the themes) and then make a note of the codes that exemplify the thoughts and feelings of your participants. It is generally advisable to put in the quotations that you want to use for each theme, using each quotation only once. After all this is done, the telling of the story can begin as you give your voice to the experiences of the participants, writing around their quotations. Do not be afraid to draw assumptions from the participants’ narratives, as this is necessary to give an in-depth account of the phenomena in question. Discuss these assumptions, drawing on your participants’ words to support you as you move from one code to another and from one theme to the next. Finally, as appropriate, it is possible to include examples from literature or policy documents that add support for your findings. As an exercise, you may wish to code and theme the sample excerpt in Appendix 1 and tell the participant’s story in your own way. Further reading about “doing” qualitative research can be found at the end of this paper.

CONCLUSIONS

Qualitative research can help researchers to access the thoughts and feelings of research participants, which can enable development of an understanding of the meaning that people ascribe to their experiences. It can be used in pharmacy practice research to explore how patients feel about their health and their treatment. Qualitative research has been used by pharmacists to explore a variety of questions and problems (see the “Further Reading” section for examples). An understanding of these issues can help pharmacists and other health care professionals to tailor health care to match the individual needs of patients and to develop a concordant relationship. Doing qualitative research is not easy and may require a complete rethink of how research is conducted, particularly for researchers who are more familiar with quantitative approaches. There are many ways of conducting qualitative research, and this paper has covered some of the practical issues regarding data collection, analysis, and management. Further reading around the subject will be essential to truly understand this method of accessing peoples’ thoughts and feelings to enable researchers to tell participants’ stories.

Appendix 1. Excerpt from a sample transcript

The participant (age late 50s) had suffered from a chronic mental health illness for 30 years. The participant had become a “revolving door patient,” someone who is frequently in and out of hospital. As the participant talked about past experiences, the researcher asked:

• What was treatment like 30 years ago?
• Umm—well it was pretty much they could do what they wanted with you because I was put into the er, the er kind of system er, I was just on
• endless section threes.
• Really…
• But what I didn’t realize until later was that if you haven’t actually posed a threat to someone or yourself they can’t really do that but I didn’t know
• that. So wh-when I first went into hospital they put me on the forensic ward ’cause they said, “We don’t think you’ll stay here we think you’ll just
• run-run away.” So they put me then onto the acute admissions ward and – er – I can remember one of the first things I recall when I got onto that
• ward was sitting down with a er a Dr XXX. He had a book this thick [gestures] and on each page it was like three questions and he went through
• all these questions and I answered all these questions. So we’re there for I don’t maybe two hours doing all that and he asked me he said “well
• when did somebody tell you then that you have schizophrenia” I said “well nobody’s told me that” so he seemed very surprised but nobody had
• actually [pause] whe-when I first went up there under police escort erm the senior kind of consultants people I’d been to where I was staying and
• ermm so er [pause] I . . . the, I can remember the very first night that I was there and given this injection in this muscle here [gestures] and just
• having dreadful side effects the next day I woke up [pause]
• . . . and I suffered that akathesia I swear to you, every minute of every day for about 20 years.
• Oh how awful.
• And that side of it just makes life impossible so the care on the wards [pause] umm I don’t know it’s kind of, it’s kind of hard to put into words
• [pause]. Because I’m not saying they were sort of like not friendly or interested but then nobody ever seemed to want to talk about your life [pause]
• nobody asked me any questions about my life. The only questions that came into was they asked me if I’d be a volunteer for these student exams
• and things and I said “yeah” so all the questions were like “oh what jobs have you done,” er about your relationships and things and er but
• nobody actually sat down and had a talk and showed some interest in you as a person you were just there basically [pause] um labelled and you
• know there was there was [pause] but umm [pause] yeah . . .

This article is the 10th in the CJHP Research Primer Series, an initiative of the CJHP Editorial Board and the CSHP Research Committee. The planned 2-year series is intended to appeal to relatively inexperienced researchers, with the goal of building research capacity among practising pharmacists. The articles, presenting simple but rigorous guidance to encourage and support novice researchers, are being solicited from authors with appropriate expertise.

Previous articles in this series:

Bond CM. The research jigsaw: how to get started. Can J Hosp Pharm . 2014;67(1):28–30.

Tully MP. Research: articulating questions, generating hypotheses, and choosing study designs. Can J Hosp Pharm . 2014;67(1):31–4.

Loewen P. Ethical issues in pharmacy practice research: an introductory guide. Can J Hosp Pharm. 2014;67(2):133–7.

Tsuyuki RT. Designing pharmacy practice research trials. Can J Hosp Pharm . 2014;67(3):226–9.

Bresee LC. An introduction to developing surveys for pharmacy practice research. Can J Hosp Pharm . 2014;67(4):286–91.

Gamble JM. An introduction to the fundamentals of cohort and case–control studies. Can J Hosp Pharm . 2014;67(5):366–72.

Austin Z, Sutton J. Qualitative research: getting started. C an J Hosp Pharm . 2014;67(6):436–40.

Houle S. An introduction to the fundamentals of randomized controlled trials in pharmacy research. Can J Hosp Pharm . 2014; 68(1):28–32.

Charrois TL. Systematic reviews: What do you need to know to get started? Can J Hosp Pharm . 2014;68(2):144–8.

Competing interests: None declared.

Further Reading

Examples of qualitative research in pharmacy practice.

• Farrell B, Pottie K, Woodend K, Yao V, Dolovich L, Kennie N, et al. Shifts in expectations: evaluating physicians’ perceptions as pharmacists integrated into family practice. J Interprof Care. 2010; 24 (1):80–9. [ PubMed ] [ Google Scholar ]
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• Marks PZ, Jennnings B, Farrell B, Kennie-Kaulbach N, Jorgenson D, Pearson-Sharpe J, et al. “I gained a skill and a change in attitude”: a case study describing how an online continuing professional education course for pharmacists supported achievement of its transfer to practice outcomes. Can J Univ Contin Educ. 2014; 40 (2):1–18. [ Google Scholar ]
• Nair KM, Dolovich L, Brazil K, Raina P. It’s all about relationships: a qualitative study of health researchers’ perspectives on interdisciplinary research. BMC Health Serv Res. 2008; 8 :110. [ PMC free article ] [ PubMed ] [ Google Scholar ]
• Pojskic N, MacKeigan L, Boon H, Austin Z. Initial perceptions of key stakeholders in Ontario regarding independent prescriptive authority for pharmacists. Res Soc Adm Pharm. 2014; 10 (2):341–54. [ PubMed ] [ Google Scholar ]

Qualitative Research in General

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Group Dynamics in Focus Groups

• Farnsworth J, Boon B. Analysing group dynamics within the focus group. Qual Res. 2010; 10 (5):605–24. [ Google Scholar ]

Social Constructivism

• Social constructivism. Berkeley (CA): University of California, Berkeley, Berkeley Graduate Division, Graduate Student Instruction Teaching & Resource Center; [cited 2015 June 4]. Available from: http://gsi.berkeley.edu/gsi-guide-contents/learning-theory-research/social-constructivism/ [ Google Scholar ]

Mixed Methods

• Creswell J. Research design: qualitative, quantitative, and mixed methods approaches. Thousand Oaks (CA): Sage Publications; 2009. [ Google Scholar ]

Collecting Qualitative Data

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Constructivist Grounded Theory

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