Qualitative Study Design and Data Collection

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6 1 journal research questions and data collection methods

  • Charles P. Friedman 4 ,
  • Jeremy C. Wyatt 5 &
  • Joan S. Ash 6  

Part of the book series: Health Informatics ((HI))

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While the prior chapter set the stage for an understanding of the nature of qualitative evaluation, this chapter will offer strategies for planning a study and making decisions about how to gather data. The process is depicted as an iterative looping through steps beginning with idea generation to dissemination of results. It is critical that strategies for rigor be incorporated throughout the process. This chapter outlines methods for data collection utilizing interviews, focus groups, observation, and naturally occurring data, and then it also describes combinations often used together, which constitute toolkits of complementary techniques.

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Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA

Charles P. Friedman

Department of Primary Care, Population Sciences and Medical Education, School of Medicine, University of Southampton, Southampton, UK

Jeremy C. Wyatt

Department of Medical Informatics and Clinical Epidemiology, School of Medicine, Oregon Health & Science University, Portland, OR, USA

Joan S. Ash

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Correspondence to Charles P. Friedman .

Answers to Self-Tests

Self-test 15.1.

Which of the strategies to ensure study rigor is primarily employed in the qualitative study scenarios below:

Data from interviews about the usability of a resource are analyzed thematically. The evaluation study team looks to see if and how similar themes have arisen in earlier meetings of the team.

Audit trail

A member of the study team, who has recently participated in another study of a similar kind of resource, becomes concerned that that person’s views about the current study are being shaped by that previous experience. That person sits with another member of the study team to share that person’s concerns and put them in perspective.

Reflexivity

At a “town hall” meeting called to present the results of a qualitative study, the sponsor of the study raises deep and serious questions about the validity of the findings. The study team returns to notes from their team meetings to review how and based on what data they came to this conclusion.

Member checking

During an evaluation project team meeting, one of the study team members finds themselves deeply repelled by off-color comments made by one of the project staff. The team member makes a note of this personal response as part of field notes.

After interviewing 10 patients participating in a study, a study team member perceives that they are hearing the same points raised by all interviewees. The team member requests a study team meeting to consider reducing the total number of interviews from 20, as previously planned, to 12.

Data saturation

A study team member “corners” a participant in a system development effort following a meeting and asks for the participant’s impressions on what transpired in the meeting.

Self-Test 15.2

Label each of the following interview scenarios, conducted as part of a qualitative study, as representing the fully structured, semi-structured or unstructured approach.

A study team member “corners” a participant in a system development project following a meeting and asks for that person’s impressions on what transpired in the meeting.

A study team member schedules time with a patient who is using an information resource to acquire specific information about the patient’s medical history.

Likely fully structured, though it could generate discussion, in which case it could veer towards semi-structured.

A study team member works with partners on the study team to develop a set of questions to be asked to all interviewees. Each question is to be followed up with the question: “Why do you think this is the case?”. At the end of the interview, subjects will be asked: “What else would you like to tell us to shed light on these matters?”

Semi-structured

An interview begins with the statement: “In general, what has been your experience using this EHR?” The remaining questions depend on how the interviewee answers this opening question.

Unstructured

A set of specific questions are read verbatim from an interview guide. No other questions are asked. The interviewees’ responses are recorded.

Fully structured

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Friedman, C.P., Wyatt, J.C., Ash, J.S. (2022). Qualitative Study Design and Data Collection. In: Evaluation Methods in Biomedical and Health Informatics. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-030-86453-8_15

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  • Data Collection Methods | Step-by-Step Guide & Examples

Data Collection Methods | Step-by-Step Guide & Examples

Published on 4 May 2022 by Pritha Bhandari .

Data collection is a systematic process of gathering observations or measurements. Whether you are performing research for business, governmental, or academic purposes, data collection allows you to gain first-hand knowledge and original insights into your research problem .

While methods and aims may differ between fields, the overall process of data collection remains largely the same. Before you begin collecting data, you need to consider:

  • The  aim of the research
  • The type of data that you will collect
  • The methods and procedures you will use to collect, store, and process the data

To collect high-quality data that is relevant to your purposes, follow these four steps.

Table of contents

Step 1: define the aim of your research, step 2: choose your data collection method, step 3: plan your data collection procedures, step 4: collect the data, frequently asked questions about data collection.

Before you start the process of data collection, you need to identify exactly what you want to achieve. You can start by writing a problem statement : what is the practical or scientific issue that you want to address, and why does it matter?

Next, formulate one or more research questions that precisely define what you want to find out. Depending on your research questions, you might need to collect quantitative or qualitative data :

  • Quantitative data is expressed in numbers and graphs and is analysed through statistical methods .
  • Qualitative data is expressed in words and analysed through interpretations and categorisations.

If your aim is to test a hypothesis , measure something precisely, or gain large-scale statistical insights, collect quantitative data. If your aim is to explore ideas, understand experiences, or gain detailed insights into a specific context, collect qualitative data.

If you have several aims, you can use a mixed methods approach that collects both types of data.

  • Your first aim is to assess whether there are significant differences in perceptions of managers across different departments and office locations.
  • Your second aim is to gather meaningful feedback from employees to explore new ideas for how managers can improve.

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Based on the data you want to collect, decide which method is best suited for your research.

  • Experimental research is primarily a quantitative method.
  • Interviews , focus groups , and ethnographies are qualitative methods.
  • Surveys , observations, archival research, and secondary data collection can be quantitative or qualitative methods.

Carefully consider what method you will use to gather data that helps you directly answer your research questions.

When you know which method(s) you are using, you need to plan exactly how you will implement them. What procedures will you follow to make accurate observations or measurements of the variables you are interested in?

For instance, if you’re conducting surveys or interviews, decide what form the questions will take; if you’re conducting an experiment, make decisions about your experimental design .

Operationalisation

Sometimes your variables can be measured directly: for example, you can collect data on the average age of employees simply by asking for dates of birth. However, often you’ll be interested in collecting data on more abstract concepts or variables that can’t be directly observed.

Operationalisation means turning abstract conceptual ideas into measurable observations. When planning how you will collect data, you need to translate the conceptual definition of what you want to study into the operational definition of what you will actually measure.

  • You ask managers to rate their own leadership skills on 5-point scales assessing the ability to delegate, decisiveness, and dependability.
  • You ask their direct employees to provide anonymous feedback on the managers regarding the same topics.

You may need to develop a sampling plan to obtain data systematically. This involves defining a population , the group you want to draw conclusions about, and a sample, the group you will actually collect data from.

Your sampling method will determine how you recruit participants or obtain measurements for your study. To decide on a sampling method you will need to consider factors like the required sample size, accessibility of the sample, and time frame of the data collection.

Standardising procedures

If multiple researchers are involved, write a detailed manual to standardise data collection procedures in your study.

This means laying out specific step-by-step instructions so that everyone in your research team collects data in a consistent way – for example, by conducting experiments under the same conditions and using objective criteria to record and categorise observations.

This helps ensure the reliability of your data, and you can also use it to replicate the study in the future.

Creating a data management plan

Before beginning data collection, you should also decide how you will organise and store your data.

  • If you are collecting data from people, you will likely need to anonymise and safeguard the data to prevent leaks of sensitive information (e.g. names or identity numbers).
  • If you are collecting data via interviews or pencil-and-paper formats, you will need to perform transcriptions or data entry in systematic ways to minimise distortion.
  • You can prevent loss of data by having an organisation system that is routinely backed up.

Finally, you can implement your chosen methods to measure or observe the variables you are interested in.

The closed-ended questions ask participants to rate their manager’s leadership skills on scales from 1 to 5. The data produced is numerical and can be statistically analysed for averages and patterns.

To ensure that high-quality data is recorded in a systematic way, here are some best practices:

  • Record all relevant information as and when you obtain data. For example, note down whether or how lab equipment is recalibrated during an experimental study.
  • Double-check manual data entry for errors.
  • If you collect quantitative data, you can assess the reliability and validity to get an indication of your data quality.

Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by academics, governments, businesses, and other organisations.

When conducting research, collecting original data has significant advantages:

  • You can tailor data collection to your specific research aims (e.g., understanding the needs of your consumers or user testing your website).
  • You can control and standardise the process for high reliability and validity (e.g., choosing appropriate measurements and sampling methods ).

However, there are also some drawbacks: data collection can be time-consuming, labour-intensive, and expensive. In some cases, it’s more efficient to use secondary data that has already been collected by someone else, but the data might be less reliable.

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to test a hypothesis by systematically collecting and analysing data, while qualitative methods allow you to explore ideas and experiences in depth.

Reliability and validity are both about how well a method measures something:

  • Reliability refers to the  consistency of a measure (whether the results can be reproduced under the same conditions).
  • Validity   refers to the  accuracy of a measure (whether the results really do represent what they are supposed to measure).

If you are doing experimental research , you also have to consider the internal and external validity of your experiment.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

Operationalisation means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioural avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalise the variables that you want to measure.

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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 ]
  • Gregory P, Austin Z. Postgraduation employment experiences of new pharmacists in Ontario in 2012–2013. Can Pharm J. 2014; 147 (5):290–9. [ PMC free article ] [ PubMed ] [ Google Scholar ]
  • 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

  • Breakwell GM, Hammond S, Fife-Schaw C. Research methods in psychology. Thousand Oaks (CA): Sage Publications; 1995. [ Google Scholar ]
  • Given LM. 100 questions (and answers) about qualitative research. Thousand Oaks (CA): Sage Publications; 2015. [ Google Scholar ]
  • Miles B, Huberman AM. Qualitative data analysis. Thousand Oaks (CA): Sage Publications; 2009. [ Google Scholar ]
  • Patton M. Qualitative research and evaluation methods. Thousand Oaks (CA): Sage Publications; 2002. [ Google Scholar ]
  • Willig C. Introducing qualitative research in psychology. Buckingham (UK): Open University Press; 2001. [ Google Scholar ]

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

  • Arksey H, Knight P. Interviewing for social scientists: an introductory resource with examples. Thousand Oaks (CA): Sage Publications; 1999. [ Google Scholar ]
  • Guest G, Namey EE, Mitchel ML. Collecting qualitative data: a field manual for applied research. Thousand Oaks (CA): Sage Publications; 2013. [ Google Scholar ]

Constructivist Grounded Theory

  • Charmaz K. Grounded theory: objectivist and constructivist methods. In: Denzin N, Lincoln Y, editors. Handbook of qualitative research. 2nd ed. Thousand Oaks (CA): Sage Publications; 2000. pp. 509–35. [ Google Scholar ]

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  • Published: 22 March 2008

Methods of data collection in qualitative research: interviews and focus groups

  • P. Gill 1 ,
  • K. Stewart 2 ,
  • E. Treasure 3 &
  • B. Chadwick 4  

British Dental Journal volume  204 ,  pages 291–295 ( 2008 ) Cite this article

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Interviews and focus groups are the most common methods of data collection used in qualitative healthcare research

Interviews can be used to explore the views, experiences, beliefs and motivations of individual participants

Focus group use group dynamics to generate qualitative data

Qualitative research in dentistry

Conducting qualitative interviews with school children in dental research

Analysing and presenting qualitative data

This paper explores the most common methods of data collection used in qualitative research: interviews and focus groups. The paper examines each method in detail, focusing on how they work in practice, when their use is appropriate and what they can offer dentistry. Examples of empirical studies that have used interviews or focus groups are also provided.

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Professionalism in dentistry: deconstructing common terminology, introduction.

Having explored the nature and purpose of qualitative research in the previous paper, this paper explores methods of data collection used in qualitative research. There are a variety of methods of data collection in qualitative research, including observations, textual or visual analysis (eg from books or videos) and interviews (individual or group). 1 However, the most common methods used, particularly in healthcare research, are interviews and focus groups. 2 , 3

The purpose of this paper is to explore these two methods in more detail, in particular how they work in practice, the purpose of each, when their use is appropriate and what they can offer dental research.

Qualitative research interviews

There are three fundamental types of research interviews: structured, semi-structured and unstructured. Structured interviews are, essentially, verbally administered questionnaires, in which a list of predetermined questions are asked, with little or no variation and with no scope for follow-up questions to responses that warrant further elaboration. Consequently, they are relatively quick and easy to administer and may be of particular use if clarification of certain questions are required or if there are likely to be literacy or numeracy problems with the respondents. However, by their very nature, they only allow for limited participant responses and are, therefore, of little use if 'depth' is required.

Conversely, unstructured interviews do not reflect any preconceived theories or ideas and are performed with little or no organisation. 4 Such an interview may simply start with an opening question such as 'Can you tell me about your experience of visiting the dentist?' and will then progress based, primarily, upon the initial response. Unstructured interviews are usually very time-consuming (often lasting several hours) and can be difficult to manage, and to participate in, as the lack of predetermined interview questions provides little guidance on what to talk about (which many participants find confusing and unhelpful). Their use is, therefore, generally only considered where significant 'depth' is required, or where virtually nothing is known about the subject area (or a different perspective of a known subject area is required).

Semi-structured interviews consist of several key questions that help to define the areas to be explored, but also allows the interviewer or interviewee to diverge in order to pursue an idea or response in more detail. 2 This interview format is used most frequently in healthcare, as it provides participants with some guidance on what to talk about, which many find helpful. The flexibility of this approach, particularly compared to structured interviews, also allows for the discovery or elaboration of information that is important to participants but may not have previously been thought of as pertinent by the research team.

For example, in a recent dental public heath study, 5 school children in Cardiff, UK were interviewed about their food choices and preferences. A key finding that emerged from semi-structured interviews, which was not previously thought to be as highly influential as the data subsequently confirmed, was the significance of peer-pressure in influencing children's food choices and preferences. This finding was also established primarily through follow-up questioning (eg probing interesting responses with follow-up questions, such as 'Can you tell me a bit more about that?') and, therefore, may not have emerged in the same way, if at all, if asked as a predetermined question.

The purpose of research interviews

The purpose of the research interview is to explore the views, experiences, beliefs and/or motivations of individuals on specific matters (eg factors that influence their attendance at the dentist). Qualitative methods, such as interviews, are believed to provide a 'deeper' understanding of social phenomena than would be obtained from purely quantitative methods, such as questionnaires. 1 Interviews are, therefore, most appropriate where little is already known about the study phenomenon or where detailed insights are required from individual participants. They are also particularly appropriate for exploring sensitive topics, where participants may not want to talk about such issues in a group environment.

Examples of dental studies that have collected data using interviews are 'Examining the psychosocial process involved in regular dental attendance' 6 and 'Exploring factors governing dentists' treatment philosophies'. 7 Gibson et al . 6 provided an improved understanding of factors that influenced people's regular attendance with their dentist. The study by Kay and Blinkhorn 7 provided a detailed insight into factors that influenced GDPs' decision making in relation to treatment choices. The study found that dentists' clinical decisions about treatments were not necessarily related to pathology or treatment options, as was perhaps initially thought, but also involved discussions with patients, patients' values and dentists' feelings of self esteem and conscience.

There are many similarities between clinical encounters and research interviews, in that both employ similar interpersonal skills, such as questioning, conversing and listening. However, there are also some fundamental differences between the two, such as the purpose of the encounter, reasons for participating, roles of the people involved and how the interview is conducted and recorded. 8

The primary purpose of clinical encounters is for the dentist to ask the patient questions in order to acquire sufficient information to inform decision making and treatment options. However, the constraints of most consultations are such that any open-ended questioning needs to be brought to a conclusion within a fairly short time. 2 In contrast, the fundamental purpose of the research interview is to listen attentively to what respondents have to say, in order to acquire more knowledge about the study topic. 9 Unlike the clinical encounter, it is not to intentionally offer any form of help or advice, which many researchers have neither the training nor the time for. Research interviewing therefore requires a different approach and a different range of skills.

The interview

When designing an interview schedule it is imperative to ask questions that are likely to yield as much information about the study phenomenon as possible and also be able to address the aims and objectives of the research. In a qualitative interview, good questions should be open-ended (ie, require more than a yes/no answer), neutral, sensitive and understandable. 2 It is usually best to start with questions that participants can answer easily and then proceed to more difficult or sensitive topics. 2 This can help put respondents at ease, build up confidence and rapport and often generates rich data that subsequently develops the interview further.

As in any research, it is often wise to first pilot the interview schedule on several respondents prior to data collection proper. 8 This allows the research team to establish if the schedule is clear, understandable and capable of answering the research questions, and if, therefore, any changes to the interview schedule are required.

The length of interviews varies depending on the topic, researcher and participant. However, on average, healthcare interviews last 20-60 minutes. Interviews can be performed on a one-off or, if change over time is of interest, repeated basis, 4 for example exploring the psychosocial impact of oral trauma on participants and their subsequent experiences of cosmetic dental surgery.

Developing the interview

Before an interview takes place, respondents should be informed about the study details and given assurance about ethical principles, such as anonymity and confidentiality. 2 This gives respondents some idea of what to expect from the interview, increases the likelihood of honesty and is also a fundamental aspect of the informed consent process.

Wherever possible, interviews should be conducted in areas free from distractions and at times and locations that are most suitable for participants. For many this may be at their own home in the evenings. Whilst researchers may have less control over the home environment, familiarity may help the respondent to relax and result in a more productive interview. 9 Establishing rapport with participants prior to the interview is also important as this can also have a positive effect on the subsequent development of the interview.

When conducting the actual interview it is prudent for the interviewer to familiarise themselves with the interview schedule, so that the process appears more natural and less rehearsed. However, to ensure that the interview is as productive as possible, researchers must possess a repertoire of skills and techniques to ensure that comprehensive and representative data are collected during the interview. 10 One of the most important skills is the ability to listen attentively to what is being said, so that participants are able to recount their experiences as fully as possible, without unnecessary interruptions.

Other important skills include adopting open and emotionally neutral body language, nodding, smiling, looking interested and making encouraging noises (eg, 'Mmmm') during the interview. 2 The strategic use of silence, if used appropriately, can also be highly effective at getting respondents to contemplate their responses, talk more, elaborate or clarify particular issues. Other techniques that can be used to develop the interview further include reflecting on remarks made by participants (eg, 'Pain?') and probing remarks ('When you said you were afraid of going to the dentist what did you mean?'). 9 Where appropriate, it is also wise to seek clarification from respondents if it is unclear what they mean. The use of 'leading' or 'loaded' questions that may unduly influence responses should always be avoided (eg, 'So you think dental surgery waiting rooms are frightening?' rather than 'How do you find the waiting room at the dentists?').

At the end of the interview it is important to thank participants for their time and ask them if there is anything they would like to add. This gives respondents an opportunity to deal with issues that they have thought about, or think are important but have not been dealt with by the interviewer. 9 This can often lead to the discovery of new, unanticipated information. Respondents should also be debriefed about the study after the interview has finished.

All interviews should be tape recorded and transcribed verbatim afterwards, as this protects against bias and provides a permanent record of what was and was not said. 8 It is often also helpful to make 'field notes' during and immediately after each interview about observations, thoughts and ideas about the interview, as this can help in data analysis process. 4 , 8

Focus groups

Focus groups share many common features with less structured interviews, but there is more to them than merely collecting similar data from many participants at once. A focus group is a group discussion on a particular topic organised for research purposes. This discussion is guided, monitored and recorded by a researcher (sometimes called a moderator or facilitator). 11 , 12

Focus groups were first used as a research method in market research, originating in the 1940s in the work of the Bureau of Applied Social Research at Columbia University. Eventually the success of focus groups as a marketing tool in the private sector resulted in its use in public sector marketing, such as the assessment of the impact of health education campaigns. 13 However, focus group techniques, as used in public and private sectors, have diverged over time. Therefore, in this paper, we seek to describe focus groups as they are used in academic research.

When focus groups are used

Focus groups are used for generating information on collective views, and the meanings that lie behind those views. They are also useful in generating a rich understanding of participants' experiences and beliefs. 12 Suggested criteria for using focus groups include: 13

As a standalone method, for research relating to group norms, meanings and processes

In a multi-method design, to explore a topic or collect group language or narratives to be used in later stages

To clarify, extend, qualify or challenge data collected through other methods

To feedback results to research participants.

Morgan 12 suggests that focus groups should be avoided according to the following criteria:

If listening to participants' views generates expectations for the outcome of the research that can not be fulfilled

If participants are uneasy with each other, and will therefore not discuss their feelings and opinions openly

If the topic of interest to the researcher is not a topic the participants can or wish to discuss

If statistical data is required. Focus groups give depth and insight, but cannot produce useful numerical results.

Conducting focus groups: group composition and size

The composition of a focus group needs great care to get the best quality of discussion. There is no 'best' solution to group composition, and group mix will always impact on the data, according to things such as the mix of ages, sexes and social professional statuses of the participants. What is important is that the researcher gives due consideration to the impact of group mix (eg, how the group may interact with each other) before the focus group proceeds. 14

Interaction is key to a successful focus group. Sometimes this means a pre-existing group interacts best for research purposes, and sometimes stranger groups. Pre-existing groups may be easier to recruit, have shared experiences and enjoy a comfort and familiarity which facilitates discussion or the ability to challenge each other comfortably. In health settings, pre-existing groups can overcome issues relating to disclosure of potentially stigmatising status which people may find uncomfortable in stranger groups (conversely there may be situations where disclosure is more comfortable in stranger groups). In other research projects it may be decided that stranger groups will be able to speak more freely without fear of repercussion, and challenges to other participants may be more challenging and probing, leading to richer data. 13

Group size is an important consideration in focus group research. Stewart and Shamdasani 14 suggest that it is better to slightly over-recruit for a focus group and potentially manage a slightly larger group, than under-recruit and risk having to cancel the session or having an unsatisfactory discussion. They advise that each group will probably have two non-attenders. The optimum size for a focus group is six to eight participants (excluding researchers), but focus groups can work successfully with as few as three and as many as 14 participants. Small groups risk limited discussion occurring, while large groups can be chaotic, hard to manage for the moderator and frustrating for participants who feel they get insufficient opportunities to speak. 13

Preparing an interview schedule

Like research interviews, the interview schedule for focus groups is often no more structured than a loose schedule of topics to be discussed. However, in preparing an interview schedule for focus groups, Stewart and Shamdasani 14 suggest two general principles:

Questions should move from general to more specific questions

Question order should be relative to importance of issues in the research agenda.

There can, however, be some conflict between these two principles, and trade offs are often needed, although often discussions will take on a life of their own, which will influence or determine the order in which issues are covered. Usually, less than a dozen predetermined questions are needed and, as with research interviews, the researcher will also probe and expand on issues according to the discussion.

Moderating a focus group looks easy when done well, but requires a complex set of skills, which are related to the following principles: 15

Participants have valuable views and the ability to respond actively, positively and respectfully. Such an approach is not simply a courtesy, but will encourage fruitful discussions

Moderating without participating: a moderator must guide a discussion rather than join in with it. Expressing one's own views tends to give participants cues as to what to say (introducing bias), rather than the confidence to be open and honest about their own views

Be prepared for views that may be unpalatably critical of a topic which may be important to you

It is important to recognise that researchers' individual characteristics mean that no one person will always be suitable to moderate any kind of group. Sometimes the characteristics that suit a moderator for one group will inhibit discussion in another

Be yourself. If the moderator is comfortable and natural, participants will feel relaxed.

The moderator should facilitate group discussion, keeping it focussed without leading it. They should also be able to prevent the discussion being dominated by one member (for example, by emphasising at the outset the importance of hearing a range of views), ensure that all participants have ample opportunity to contribute, allow differences of opinions to be discussed fairly and, if required, encourage reticent participants. 13

Other relevant factors

The venue for a focus group is important and should, ideally, be accessible, comfortable, private, quiet and free from distractions. 13 However, while a central location, such as the participants' workplace or school, may encourage attendance, the venue may affect participants' behaviour. For example, in a school setting, pupils may behave like pupils, and in clinical settings, participants may be affected by any anxieties that affect them when they attend in a patient role.

Focus groups are usually recorded, often observed (by a researcher other than the moderator, whose role is to observe the interaction of the group to enhance analysis) and sometimes videotaped. At the start of a focus group, a moderator should acknowledge the presence of the audio recording equipment, assure participants of confidentiality and give people the opportunity to withdraw if they are uncomfortable with being taped. 14

A good quality multi-directional external microphone is recommended for the recording of focus groups, as internal microphones are rarely good enough to cope with the variation in volume of different speakers. 13 If observers are present, they should be introduced to participants as someone who is just there to observe, and sit away from the discussion. 14 Videotaping will require more than one camera to capture the whole group, as well as additional operational personnel in the room. This is, therefore, very obtrusive, which can affect the spontaneity of the group and in a focus group does not usually yield enough additional information that could not be captured by an observer to make videotaping worthwhile. 15

The systematic analysis of focus group transcripts is crucial. However, the transcription of focus groups is more complex and time consuming than in one-to-one interviews, and each hour of audio can take up to eight hours to transcribe and generate approximately 100 pages of text. Recordings should be transcribed verbatim and also speakers should be identified in a way that makes it possible to follow the contributions of each individual. Sometimes observational notes also need to be described in the transcripts in order for them to make sense.

The analysis of qualitative data is explored in the final paper of this series. However, it is important to note that the analysis of focus group data is different from other qualitative data because of their interactive nature, and this needs to be taken into consideration during analysis. The importance of the context of other speakers is essential to the understanding of individual contributions. 13 For example, in a group situation, participants will often challenge each other and justify their remarks because of the group setting, in a way that perhaps they would not in a one-to-one interview. The analysis of focus group data must therefore take account of the group dynamics that have generated remarks.

Focus groups in dental research

Focus groups are used increasingly in dental research, on a diverse range of topics, 16 illuminating a number of areas relating to patients, dental services and the dental profession. Addressing a special needs population difficult to access and sample through quantitative measures, Robinson et al . 17 used focus groups to investigate the oral health-related attitudes of drug users, exploring the priorities, understandings and barriers to care they encounter. Newton et al . 18 used focus groups to explore barriers to services among minority ethnic groups, highlighting for the first time differences between minority ethnic groups. Demonstrating the use of the method with professional groups as subjects in dental research, Gussy et al . 19 explored the barriers to and possible strategies for developing a shared approach in prevention of caries among pre-schoolers. This mixed method study was very important as the qualitative element was able to explain why the clinical trial failed, and this understanding may help researchers improve on the quantitative aspect of future studies, as well as making a valuable academic contribution in its own right.

Interviews and focus groups remain the most common methods of data collection in qualitative research, and are now being used with increasing frequency in dental research, particularly to access areas not amendable to quantitative methods and/or where depth, insight and understanding of particular phenomena are required. The examples of dental studies that have employed these methods also help to demonstrate the range of research contexts to which interview and focus group research can make a useful contribution. The continued employment of these methods can further strengthen many areas of dentally related work.

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Gill, P., Stewart, K., Treasure, E. et al. Methods of data collection in qualitative research: interviews and focus groups. Br Dent J 204 , 291–295 (2008). https://doi.org/10.1038/bdj.2008.192

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Quantification supports amyloid-PET visual assessment of challenging cases: results from the AMYPAD-DPMS study

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Several studies have demonstrated the high agreement between routine clinical visual assessment and quantification, suggesting that quantification approaches could support the assessment of less experienced readers and/or in challenging cases. However, all studies to date have implemented a retrospective case collection and challenging cases were generally underrepresented.

Methods In this prospective study, we included all participants ( N =741) from the AMYPAD Diagnostic and Patient Management Study (DPMS) with available baseline amyloid-PET quantification. Quantification was done with the PET-only AmyPype pipeline, providing global Centiloid (CL) and regional z-scores. Visual assessment was performed by local readers for the entire cohort. From the total cohort, we selected a subsample of 85 cases 1) for which the amyloid status based on the local reader’s visual assessment and CL classification (cut-off=21) was discordant and/or 2) that were assessed with a low confidence (i.e. ≤3 on a 5-point scale) by the local reader. In addition, concordant negative ( N =8) and positive ( N =8) scans across tracers were selected. In this sample, ( N =101 cases: ([ 18 F]flutemetamol, N =48; [ 18 F]florbetaben, N =53) the visual assessments and corresponding confidence by 5 certified independent central readers were captured before and after disclosure of the quantification results.

Results For the AMYPAD-DPMS whole cohort, the overall assessment of local readers highly agreed with CL status (κ=0.85, 92.3% agreement). This was consistently observed within disease stages (SCD+: κ=0.82/92.3%; MCI: κ=0.80/89.8%; dementia: κ=0.87/94.6%). Across all central reader assessments in the challenging subsample, global CL and regional z-scores quantification were considered supportive of visual read in 70.3% and 49.3% of assessments, respectively. After disclosure of quantitative results, we observed an improvement in concordance between the 5 readers (κ baseline =0.65/65.3%; κ post-disclosure =0.74/73.3%) and a significant increase in reader confidence ( M baseline =4.0 vs. M post-disclosure =4.34, W =101056, p <0.001).

Conclusion In this prospective study enriched for challenging amyloid-PET cases, we demonstrate the value of quantification to support visual assessment. After disclosure, both inter-reader agreement and confidence showed a significant improvement. These results are important considering the arrival of anti-amyloid therapies, which utilized the Centiloid metric for trial inclusion and target-engagement. Moreover, quantification could support determining Aβ status with high certainty, an important factor for treatment initiation.

Competing Interest Statement

DISCLOSURES DA, IB, DVG, ILA, AP, and GBF report no relevant disclosures. LEC has received research support from GE Healthcare and Springer Healthcare (funded by Eli Lilly), both paid to institution. Dr. Collij s salary is supported by the MSCA postdoctoral fellowship research grant (#101108819) and the Alzheimer Association Research Fellowship (AARF) grant (#23AARF-1029663). GNB is funded by the Deutsche Forschungsgemeinschaft (DFG) Project ID 431549029 - SFB 1451 and partially by DFG, DR 445/9 1. MB is employed by GE HealthCare. RW is employed by IXICO ltd. RG is employed by Life Molecular Imaging AWS is employed by Life Molecular Imaging ZW has received research support from GE Healthcare. PS is employed by EQT Life Sciences team. AN has received consulting fee from H Lundbeck AB, AVVA pharmaceuticals and honoraria for lecture from Hoffman La Roche. JDG has received research support from GE HealthCare, Roche Diagnostics and Hoffmann La Roche, speaker/consulting fees from Roche Diagnostics, Esteve, Philips Nederlands, Biogen and Life Molecular Imaging and serves in the Molecular Neuroimaging Advisory Board of Prothena Biosciences. AD has received research support from: Siemens Healthineers, Life Molecular Imaging, GE Healthcare, AVID Radiopharmaceuticals, Sofie, Eisai, Novartis/AAA, Ariceum Therapeutics, speaker Honorary/Advisory Boards: Siemens Healthineers, Sanofi, GE Healthcare, Biogen, Novo Nordisk, Invicro, Novartis/AAA, Bayer Vital, Lilly Stock: Siemens Healthineers, Lantheus Holding, Structured therapeutics, Lilly. Patents: Patent for 18F JK PSMA 7 (Patent No.: EP3765097A1; Date of patent: Jan. 20, 2021). SM received speaker honoraria from GE Healthcare, Eli Lilly and Life Molecular Imaging. CB is employed by GE HealthCare. VG is supported by the Swiss national science foundation (project n.320030_185028 and 320030_169876), the Aetas Foundation, the Schmidheiny Foundation, the Velux Foundation, the Fondation privee des HUG. She received support for research and speakers fees from Siemens Healthineers, GE HealthCare, Janssen, Novo Nordisk, all paid to institution. GF is employed by GE HealthCare. FB is supported by the NIHR biomedical research centre at UCLH. Steering committee or Data Safety Monitoring Board member for Biogen, Merck, Eisai and Prothena. Advisory board member for Combinostics, Scottish Brain Sciences. Consultant for Roche, Celltrion, Rewind Therapeutics, Merck, Bracco. Research agreements with ADDI, Merck, Biogen, GE Healthcare, Roche. Co-founder and shareholder of Queen Square Analytics LTD.

Funding Statement

ACKNOWLEDGMENTS The project leading to this paper has also received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115952. This Joint Undertaking receives the support from the European Union s Horizon 2020 research and innovation programme and EFPIA. This communication reflects the views of the authors and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.

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I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

All participants gave written informed consent. The trial was registered with EudraCT (2017-002527-21). The study was approved by the CCER (Commission Cantonale d Ethique de la Recherche) in Geneva Switzerland (#2017-01408).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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  27. Infection Control Basics

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