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The scope of family medicine research, declaration, challenges for family medicine research: a global perspective.

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Amanda Howe, Michael Kidd, Challenges for family medicine research: a global perspective, Family Practice , Volume 36, Issue 2, April 2019, Pages 99–101, https://doi.org/10.1093/fampra/cmy044

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Family medicine (FM) is the most explicitly generalist speciality in medical practice—defining itself by its utilization of interpersonal dynamics and the patient’s perspective. Its clinical scope extends across the lifecycle, from self-empowerment to end of life care; family doctors are trained to engage with population needs as well as active demand ( 1 ). Little wonder then that the scope of FM research is equally broad and often informed by disciplines from the social as well as the epidemiological and biological sciences. From dancing for dementia to the gut microbiome, FM academics can justify engagement in any aspect that may affect the health of their individual patients or the communities they serve. In some countries, as much as 90% of care in a health system is led by GPs/family doctors and their teams—but the proportion of medical research coming from primary care is much less. This article reviews some of the key challenges and opportunities from a global perspective.

Challenge 1: establishing a new speciality

In many countries, doctors working in primary care settings have had no postgraduate training, and the speciality of FM is relatively new. Creating a new speciality needs an academic presence in universities, to give clinical, educational and research leadership, which in the UK took more than 25 years ( 2 , 3 ). The profile of the early researchers in FM was crucial to attaining respect from other specialities and to the improvement in the overall status and quality of practice ( 4 ). In recent years, there are several examples (e.g. Palestine, Ethiopia) where the first step towards establishing the discipline of FM has been in academic settings, and where our young discipline is still challenged by the need to develop capacity to enable high-impact research. This then raises the question of what such units need in terms of goals—and support.

Challenge 2: building the research infrastructure

While many health care systems worldwide are still early in the development of research units with family doctor academics and primary care-specific research programmes, many also lack the infrastructure to do research in primary care settings—partly because this sector remains underdeveloped compared with specialties based in the hospital sector. Particularly in lower income countries, there is a version of the ‘inverse care law’ ( 5 ), where the most needy in the population get the least good care at far too late a stage, and research and evaluation capacity is so weak that this gap often remains invisible ( 6 ). This is partly because it is common for national funders of research to work with universities, clinical units, commercial providers and charities. Such partnerships can fund research structures (networks or institutes), support academic posts and career opportunities, and undertake specific programmes of work that reflect population health needs. Primary health care (PHC), with its dispersed geographical spread and often a multitude of employers and funders, needs similar investment—but may need a more ‘networked’ model to receive and sustain academic funding and activities. Examples of countries making such investment successfully include the UK National Institute of Health Research School for Primary Care Research and Netherlands Institute for Health Services Research. Notably, the US National Institutes of Health lacks an equivalent structure.

Challenge 3: equitable resources

The current situation reported by high-income countries shows some bias in research funding towards bioscience, rather than research that is oriented to clinical practice and human behaviours. The emphasis of funders, including the commercial sector, plays a crucial part in directing what research gets done. Translational research—defined as ‘the principle of turning fundamental discoveries into improvements in human health and economic benefit’ ( 7 )—tends to be biased towards ‘laboratory to bedside’ funding and process; but translating findings into primary, community and societal settings may be equally challenging and important ( 8 ). Figures from reports from the UK’s Clinical Research Collaboration report in 2015 showed a shift over a 5-year period towards applied research and away from pharmaceutically driven programmes; but applied research funding remained at a mere 6% ( 9 ), with the primary care component of that work not specified. Even when research occurs in primary care, it may be oriented more towards acute care interventions than to disease prevention, chronic disease management and population health.

Challenge 4: getting the message across

To persuade others to rebalance investment towards primary care and FM research, there are three key arguments: relevance, ecological validity and public accountability ( 10 ). To decide how to spend research funding, countries frequently undertake a process of priority setting ( 11 ), so that the funding will deliver to national needs with maximum value. One example of poor investment is doing the right research in the wrong place—making recommendations for clinical care based predominantly on hospital patients will overmedicalize ( 12 ) care and can waste money as well as wisdom ( 13 ). Data from populations and communities are the only way to understand the full picture of a country’s health: this is the rationale for building primary care-based research networks. In the USA, the Patient-Centered Outcomes Research Institute has invested tens of millions of dollars to build clinical data research networks with a national distribution. Such resources should facilitate research in the ‘real world’ environment, that is the primary care practice.

The need for more person- and community-oriented research is also made by civil society, as we become more aware of the need to emphasize ‘integrated person-centred health services’ ( 14 )—to learn how best to give a voice for all citizens, achieve equitable and effective health care, address the ageing demographic and minimize the costs and clinical impacts of noncommunicable diseases and mental health disorders.

Applied research includes health system research and the need to establish effective models of health care. While there are different pathways to creating a modern health care system that achieves effective universal health coverage through strengthening PHC ( 15 ), much of the evidence and leadership for such initiatives will come through research findings and their application to policy and practice. Another lens is global health, where an emphasis on the ‘needs of the most needy’ ( 5 ) and a drive for both clinical and intellectual equity has been championed ( 16 ).

FM researchers, based on these common issues and the need for equitable opportunity, have therefore argued in recent years for (i) much more research to be done in primary care settings, (ii) building of academic capacity that informs and engages staff and patients in the PHC sector, (iii) a focus on applied research for practice transformation—what is needed and what works for improvement of services, (iv) prioritizing multimorbidity and a patient-level perspective on needs and (v) integrated approaches to mental health and behavioural interventions ( 17 ).

Challenge 5: growing academic capacity

We have advocated for enhancing academic capabilities of the family doctor, so that everyone can understand the value of hosting or leading research, apply evidence to practice, undertake evaluative projects and assist in original research. Many countries now offer a master’s-level qualification as part of the FM postgraduate training and also give access to such trainings in continuing professional development programmes. This contributes also to the competencies for team leadership and service development, as people with well-trained minds and ability to conduct critical analysis can take forward improvements in practice and implement new approaches to care.

However, many countries give family doctors fewer opportunities to develop their academic competencies than other specialists. Even with a 3- or 4-year postgraduate training, the funding for further doctoral training and supervised placement in academic departments is disproportionately low. Fifty per cent of the medical workforce may be family doctors, but even in a ‘mature’ system like the UK only 6% of academic posts are held by GPs ( 18 ): similar figures were very difficult to find for low- and middle-income countries. The barriers to achieving an academic component to one’s career may also relate to the diverse employment models for family doctors, where time out of the practice may be a direct personal cost rather than being part of a salaried contract. Many medical students and postgraduates also do not get the opportunity to undertake teaching and research opportunities in primary care and may not meet family doctors as tutors—so the idea of an academic career and professional leadership in FM may remain invisible.

A programme for action

The World Organization of Family Doctors provides a global professional network for GPs and family doctors worldwide. This group, which has existed since 1972, includes in its mission statement the need to ‘encourage and support the development of academic organizations of general practitioners/family physicians’ and hosts Research and Education Working Parties that champion the need to combine clinical practice with a learning and scholarly environment. At both national and international levels, WONCA ( 19 ) and its member organizations—which include academic units—have developed guidance for those who wish to improve the outputs of research that addresses both population health needs and human factors. For more than a decade, the WONCA network has stated its concern about the importance of research in FM and used consensus statements ( 20 ) (see Table 1 ) as the basis for advocacy. Building on this, we suggest the following.

Recommendations from the 2003 Kingston Conference on ‘Improving Health Globally: The Necessity of Family Medicine Research’ ( 20 )

PHC, primary health care.

Funders, whether governmental, charitable or commercial, should (i) reference their funding explicitly to include studies set in primary care settings that are of significant importance to the population and/or community, (ii) allocate a specified budget to projects within health services and service delivery, including implementation research, (iii) ensure that their overall programme also engages with PHC settings to test findings for their applicability and validation in non-hospital settings and (iv) prioritize global health priorities and include international partnerships and academic capacity building—for example, each grant awarded should include funding for a PhD student from a lower income country where academic capacity building is needed.

In parallel, academics (especially those working in FM and PHC units) should champion issues of primary importance to PHC and be more aware of the need for a global dimension on priorities and capacity building in their research. This is a ‘win win’ in research terms, as most institutions and funders regard international impact of research and international postgraduate recruitment as a sign of thriving academic success. But it also addresses the social accountability agenda ( 21 ). Professional leaders can work to change the paradigm, for example by challenging funding priorities, supporting initiatives where governments align aid budgets with research ( 22 ) and ensure that national and international policy is developed on these issues.

We also need to ensure that we utilize the findings of our research to advocate for the importance of FM and primary care research. While FM researchers may appreciate that family practice systems are a natural place of health and medical research and exploration, we need to let the rest of the world know that too. We urge all readers to continue to champion the academic development of FM, by setting expectations and fighting for equitable resources.

Conflict of interest: Both authors are academic family doctors, and both are or have been officeholders in the World Organization of Family Doctors (WONCA, www.globalfamilydoctor.com ), whose mission is to improve people’s health through developing family medicine. We therefore have a declaration of interest in ensuring research in primary care is strengthened.

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World Health Organization Framework on Integrated People Centred Health Services . http://www.who.int/servicedeliverysafety/areas/people-centred-care/en/ (accessed on 13 May 2018) .

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van Weel C , Rosser WW . Improving health care globally: a critical review of the necessity of family medicine research and recommendations to build research capacity . Ann Fam Med 2004 ; 2 ( suppl 2 ): S5 – 16 .

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The U.K. Newton Fund . https://www.britishcouncil.org/education/science/newton (accessed on 13 May 2018).

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What is next for family medicine? After the long, rough road since the beginning of the COVID-19 pandemic, other topics are again receiving renewed attention. Family medicine researchers continue to consider issues important to our patients and practices. There is a collection of clinical research on children’s health care. One article outlines practical actions to move medical academia past racism. The need for physician trust in patients is also often overlooked. Other articles address how to improve the practice of family medicine and a framework for thinking about legal and ethical issues in sports medicine. Three in-depth clinical reviews cover lumps and bumps of wrists and hands, spondylosis/spondylolistheses, and vitamin D association with specific disease entities.

• New Clinically Useful Tools

The Montreal Cognitive Assessment (MoCA), available at www.mocatest.org , is a common assessment of mental functioning. White et al 1 present a modification that neutralizes the effects of patients’ education on their performance on the MoCA. Another clinical tool, the Lehigh Outpatient COVID Hospitalization (LOCH) risk score, which predicts hospitalization secondary to acute COVID-19 infection, was developed on patients as young as 12 years of age and is publicly available. 2 Infectious mononucleosis is always in the differential diagnosis when young people present with a sore throat, but testing everyone is impractical. Cai et al 3 explain the threshold at which clinicians should test for infectious mononucleosis.

Clinical Research on Children’s Health Issues

Is it ever too early to start reading to children? Does it matter? The impressive findings reported by Franks et al 4 will likely impact how strongly and when you encourage parents to start reading to their children.

Obesity rates continue to rise, even among young children. Daly et al 5 compared diet to activity levels in children ages 3 to 6. Which do you think is more closely correlated with obesity? The number of the children’s steps taken per day was also impressive.

The vaccination rate among children in America is lower than what most family physicians and public health officials recommend. Stockwell et al 6 identified factors associated with parental intent to agree to COVID vaccination for children ages 11 and younger that influence strategies to improve overall vaccination rates in this age group.

Trust is essential in the patient-physician relationship and seems particularly important related to COVID vaccination. Although not a study specifically about parents and children, Williamson et al 7 challenge us to use a bidirectional approach to trust, reminding all of the need to acknowledge the role of physician trust in patients. While always important, current political angst/struggles reinforce the need for this message.

• COVID-19 Research

Patients hospitalized with COVID-19 are at increased risk of venous thromboembolism. A retrospective observational study of nearly 170,000 patients in Minnesota identified the risk of thromboembolic disease due to cases of COVID-19 that were mild enough to avoid hospitalization. 8

Further, it is not surprising that many patients’ medical care was delayed during the pandemic. The long-term implications of those delays are materializing. 9 The pandemic had an effect on socializing, with an increase in social isolation. Mosen et al 10 report on the relationship between social isolation and memory loss in older adults. Their findings suggest research studies are needed to determine whether reducing social isolation can prevent memory loss.

JABFM recently published data that suggested that the COVID-19 pandemic has caused many family medicine educators to rethink their futures. 11 In this issue, evidence shows graduating residents’ intentions regarding their future scope of practice did not change in the wake of the pandemic. 12

• Other Clinical Topics

The first Clinical Review in this issue provides a useful overview of lumps and bumps on the fingers, hands, and wrists. Some causes are common and easily handled by family physicians, while others are uncommon and require specialty care. 13 The second Clinical Review presents the diagnosis and management of 2 common causes of low back pain in adolescents—spondylosis and isthmic spondylolisthesis. 14 Completing the trio of Clinical Reviews for this issue, evidence regarding vitamin D supplementation for a variety of common conditions is summarized. The findings are a good reminder that physicians should think through the difference between association and causation when it comes to this commonly prescribed supplement. 15

Sports medicine physicians often face unique legal and ethical questions when seeing athletes as patients. The Ethics Feature in this issue suggests a framework for working through the challenging and layered situations that sports physicians face. 16

• Next Steps to Attain Health Care Justice

Edgoose et al 17 articulate a thought-provoking consideration of race and racism in medicine with explicit, practical actions to be taken at multiple levels. “Medical academia (must) implement policies that explicitly hold us accountable to maintain a clear understanding of race as a socio-political construct so that we can conduct research, disseminate scholarly work, teach, and practice clinically with more clarity about race and racism.” The article provides actionable examples to enact for individuals, relationships, communities, and the population, as well as implications for institutions, governance, and policies. May it be so .

Transgender patients are often marginalized in society. What experiences do they have when seeking health care? The answers are discouraging. As a profession, we must improve to provide quality care for these patients. 18 Nederveld et al 19 report on socioeconomic factors related to patients’ diabetes distress.

• Improving Practice

Improving the organization and outcomes of primary care practices is a challenge because of competing demands and inadequate resources. Providing external support to practices to assist change is also frequently fraught with challenges. Cohen et al 20 investigate whether the past experience of an external supporting entity improved clinical outcomes of primary care practices. The simple answer is “yes.” The more difficult question is, “How can we implement more broadly?” Cohen et al 21 also studied the insights of leaders from high-performing community health centers identifying which modifiable organizational features make providing high-quality chronic disease care more achievable.

An implementation science article by Baldwin et al 22 reminds us how important it is to include team members directly involved in patient care in the decision-making process when attempting to improve clinical processes. The strategy used can serve as a model for others to follow.

• The Future of Primary Care

The JABFM editors believe the United States needs to invest more heavily in primary care overall. It is neither sufficient nor reasonable to expect health care improvements through intense efforts of the primary care practices themselves without adequate resources. A yet more expansive opinion with 3 recommendations for primary care change is offered by Dr. William Miller. 23 His thoughts are in response to the impressions of primary care expressed by respondents to the Larry A. Green Center’s intermittent, widely distributed anonymous surveys.

Conflicts of interest: The authors are editors of the JABFM .

To see this article online, please go to: http://jabfm.org/content/35/6/1039.full .

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Fundamentals of case study research in family medicine and community health

Michael D Fetters .

https://doi.org/ 10.1136/fmch-2018-000074

The aim of this article is to introduce family medicine researchers to case study research, a rigorous research methodology commonly used in the social and health sciences and only distantly related to clinical case reports. The article begins with an overview of case study in the social and health sciences, including its definition, potential applications, historical background and core features. This is followed by a 10-step description of the process of conducting a case study project illustrated using a case study conducted about a teaching programme executed to teach international family medicine resident learners sensitive examination skills. Steps for conducting a case study include (1) conducting a literature review; (2) formulating the research questions; (3) ensuring that a case study is appropriate; (4) determining the type of case study design; (5) defining boundaries of the case(s) and selecting the case(s); (6) preparing for data collection; (7) collecting and organising the data; (8) analysing the data; (9) writing the case study report; and (10) appraising the quality. Case study research is a highly flexible and powerful research tool available to family medicine researchers for a variety of applications.

• Significance statement

Given their potential for answering ‘how’ and ‘why’ questions about complex issues in their natural setting, case study designs are being increasingly used in the health sciences. Conducting a case study can, however, be a complex task because of the possibility of combining multiple methods and the need to choose between different types of case study designs. In order to introduce family medicine and community health researchers to the fundamentals of case study research, this article reviews its definition, potential applications, historical background and main characteristics. It follows on with a practical, step-by-step description of the case study process that will be useful to researchers interested in implementing this research design in their own practice.

• Introduction

This article provides family medicine and community health researchers a concise resource to conduct case study research. The article opens with an overview of case study in the social and health sciences, including its definition, potential applications, historical background and core features. This is followed by a 10-step description of the process of conducting a case study project, as described in the literature. These steps are illustrated using a case study about a teaching programme executed to teach international medical learners sensitive examination skills. The article ends with recommendations of useful articles and textbooks on case study research.

• Origins of case study research

Case study is a research design that involves an intensive and holistic examination of a contemporary phenomenon in a real-life setting. 1–3 It uses a variety of methods and multiple data sources to explore, describe or explain a single case bounded in time and place (ie, an event, individual, group, organisation or programme). A distinctive feature of case study is its focus on the particular characteristics of the case being studied and the contextual aspects, relationships and processes influencing it. 4 Here we do not include clinical case reports as these are beyond the scope of this article. While distantly related to clinical case reports commonly used to report unusual clinical case presentations or findings, case study is a research approach that is frequently used in the social sciences and health sciences. In contrast to other research designs, such as surveys or experiments, a key strength of case study is that it allows the researcher to adopt a holistic approach—rather than an isolated approach—to the study of social phenomena. As argued by Yin, 3 case studies are particularly suitable for answering ‘how’ research questions (ie, how a treatment was received) as well as ‘why’ research questions (ie, why the treatment produced the observed outcomes).

Given its potential for understanding complex processes as they occur in their natural setting, case study increasingly is used in a wide range of health-related disciplines and fields, including medicine, 5 nursing, 6 health services research 1 and health communication. 7 With regard to clinical practice and research, a number of authors 1 5 8 have highlighted how insights gained from case study designs can be used to describe patients’ experiences regarding care, explore health professionals’ perceptions regarding a policy change, and understand why medical treatments and complex interventions succeed or fail.

In anthropology and sociology, case study as a research design was introduced as a response to the prevailing view of quantitative research as the primary way of undertaking research. 9 From its beginnings, social scientists saw case study as a method to obtain comprehensive accounts of social phenomena from participants. In addition, it could complement the findings of survey research. Between the 1920s and 1960s, case study became the predominant research approach among the members of the Department of Sociology of the University of Chicago, widely known as ‘The Chicago School’. 10 11 During this period, prominent sociologists, such as Florian Znaniecki, William Thomas, Everett C Hughes and Howard S Becker, undertook a series of innovative case studies (including classical works such as The Polish peasant in Europe and America or Boys in White ), which laid the foundations of case study designs as implemented today.

In the 1970s, case study increasingly was adopted in the USA and UK in applied disciplines and fields, such as education, programme evaluation and public policy research. 12 As a response to the limitations of quasi-experimental designs for undertaking comprehensive programme evaluations, researchers in these disciplines saw in case studies—either alone or in combination with experimental designs—an opportunity to gain additional insights into the outcomes of programme implementation. In the mid-1980s and early 1990s, the case study approach became recognised as having its own ‘logic of design’ (p46). 13 This period coincides with the publication of a considerable number of influential articles 14–16 and textbooks 4 17 18 on case study research.

These publications were instrumental in shaping contemporary case study practice, yet they reflected divergent views about the nature of case study, including how it should be defined, designed and implemented (see Yazan 19 for a comparison of the perspectives of Yin, Merriam and Stake, three leading case study methodologists). What these publications have in common is that case study revolves around four key features.

First, case study examines a specific phenomenon in detail by performing an indepth and intensive analysis of the selected case. The rationale for case study designs, rather than more expansive designs such as surveys, is that the researcher is interested in investigating the particularity of a case, that is, the unique attributes that define an event, individual, group, organisation or programme. 2 Second, case study is conducted in natural settings where people meet, interact and change their perceptions over time. The use of the case study design is a choice in favour of ‘maintaining the naturalness of the research situation and the natural course of events’ (p177). 20

Third, case study assumes that a case under investigation is entangled with the context in which it is embedded. This context entails a number of interconnected processes that cannot be disassociated from the case, but rather are part of the study. The case study researcher is interested in understanding how and why such processes take place and, consequently, uncovering the interactions between a case and its context. Research questions concerning how and why phenomena occur are particularly appropriate in case study research. 3

Fourth, case study encourages the researcher to use a variety of methods and data types in a single study. 20 21 These can be solely qualitative, solely quantitative or a mixture of both. The latter option allows the researcher to gain a more comprehensive understanding of the case and improve the accuracy of the findings. The four above-mentioned key features of case study are shown in table 1 , using the example of a mixed methods case study evaluation. 22

There are many potential applications for case study research. While often misconstrued as having only an exploratory role, case study research can be used for descriptive and explanatory research (p7–9). 3 Family medicine and community health researchers can use case study research for evaluating a variety of educational programmes, clinical programmes or community programmes.

• Case study illustration from family medicine

In the featured study, Japanese family medicine residents received standardised patient instructor-based training in female breast, pelvic, male genital and prostate examinations as part of an international training collaboration to launch a new family medicine residency programme. 22 From family medicine residents, trainers and staff, the authors collected and analysed data from post-training feedback, semistructured interviews and a web-based questionnaire. While the programme was perceived favourably, they noted barriers to reinforcement in their home training programme, and taboos regarding gender-specific healthcare appear as barriers to implementing a similar programme in the home institution.

• A step-by-step description of the process of carrying out a case study

As shown in table 2 and illustrated using the article by Shultz et al , 22 case study research generally includes 10 steps. While commonly conducted in this order, the steps do not always occur linearly as data collection and analysis may occur over several iterations or implemented with a slightly different order.

Step 1. Conduct a literature review

During the literature review, researchers systematically search for publications, select those most relevant to the study’s purpose, critically appraise them and summarise the major themes. The literature review helps researchers ascertain what is and is not known about the phenomenon under study, delineate the scope and research questions of the study, and develop an academic or practical justification for the study. 23

Step 2. Formulate the research questions

Research questions critically define in operational terms what will be researched and how. They focus the study and play a key role in guiding design decisions. Key decisions include the case selection and choice of a case study design most suitable for the study. According to Fraenkel et al , 24 the key attributes of good research questions are (1) feasibility, (2) clarity, (3) significance, (4) connection to previous research identified in the literature and (5) compliance with ethical research standards.

Step 3. Ensure that a case study is appropriate

Before commencing the study, researchers should ensure that case study design embodies the most appropriate strategy for answering the study questions. The above-noted four key features—in depth examination of phenomena, naturalness, a focus on context and the use of a combination of methods—should be reflected in the research questions as well as subsequent design decisions.

Step 4. Determine the type of case study design

Researchers need to choose a specific case study design. Sometimes, researchers may define the case first (step 5), for example, in a programme evaluation, and the case may need to be defined before determining the type. Yin’s 3 typology is based on two dimensions, whether the study will examine a single case or multiple cases, and whether the study will focus on a single or multiple units of analysis. Figure 1 illustrates these four types of design using a hypothetical example of a programme evaluation. Table 3 shows an example of each type from the literature.

Types of case study designs. 3 21

In type 1 holistic single case design , researchers examine a single programme as the sole unit of analysis. In type 2 embedded single case design , the interest is not exclusively in the programme, but also in its different subunits, including sites, staff and participants. These subunits constitute the range of units of analysis. In type 3 holistic multiple case design , researchers conduct a within and cross-case comparison of two or more programmes, each of which constitutes a single unit of analysis. A major strength of multiple case designs is that they enable researchers to develop an in depth description of each case and to identify patterns of variation and similarity between the cases. Multiple case designs are likely to have stronger internal validity and generate more insightful findings than single case designs. They do this by allowing ‘examination of processes and outcomes across many cases, identification of how individual cases might be affected by different environments, and the specific conditions under which a finding may occur’ (p583). 25 In type 4 embedded multiple case design , a variant of the holistic multiple case design, researchers perform a detailed examination of the subunits of each programme, rather than just examining each case as a whole.

Step 5. Define the boundaries of the case(s) and select the case(s)

Miles et al 26 define a case as ‘a phenomenon of some sort occurring in a bounded context’ (p28). What is and is not the case and how the case fits within its broader context should be explicitly defined. As noted in step 4, this step may occur before choice of the case study type, and the process may actually occur in a back-and-forth fashion. A case can entail an individual, a group, an organisation, an institution or a programme. In this step, researchers delineate the spatial and temporal boundaries of the case, that is, ‘when and where it occurred, and when and what was of interest’ (p390). 9 Aside from ensuring the coherence and consistency of the study, bounding the case ensures that the planned research project is feasible in terms of time and resources. Having access to the case and ensuring ethical research practice are two central considerations in case selection. 1

Step 6. Prepare to collect data

Before beginning the data collection, researchers need a study protocol that describes in detail the methods of data collection. The protocol should emphasise the coherence between the data collection methods and the research questions. According to Yin, 3 a case study protocol should include (1) an overview of the case study, (2) data collection procedures, (3) data collection questions and (4) a guide for the case study report. The protocol should be sufficiently flexible to allow researchers to make changes depending on the context and specific circumstances surrounding each data collection method.

Step 7. Collect and organise the data

While case study is often portrayed as a qualitative approach to research (eg, interviews, focus groups or observations), case study designs frequently rely on multiple data sources, including quantitative data (eg, surveys or statistical databases). A growing number of authors highlight the ways in which the use of mixed methods within case study designs might contribute to developing ‘a more complete understanding of the case’ (p902), 21 shedding light on ‘the complexity of a case’ (p118) 27 or increasing ‘the internal validity of a study’ (p6). 1 Guetterman and Fetters 21 explain how a qualitative case study can also be nested within a mixed methods design (ie, be considered the qualitative component of the design). An interesting strategy for organising multiple data sources is suggested by Yin. 3 He recommends using a case study database in which different data sources (eg, audio files, notes, documents or photographs) are stored for later retrieval or inspection. See guidance from Creswell and Hirose 28 for conducting a survey and qualitative data collection in mixed methods and DeJonckheere 29 on semistructured interviewing.

Step 8. Analyse the data

Bernard and Ryan 30 define data analysis as ‘the search for patterns in data and for ideas that help explain why these patterns are there in the first place’ (p109). Depending on the case study design, analysis of the qualitative and quantitative data can be done concurrently or sequentially. For the qualitative data, the first step of the analysis involves segmenting the data into coding units, ascribing codes to data segments and organising the codes in a coding scheme. 31 Depending on the role of theory in the study, an inductive, data-driven approach can be used where meaning is found in the data, or a deductive, concept-driven approach can be adopted where predefined concepts derived from the literature, or previous research, are used to code the data. 32 The second step involves searching for patterns across codes and subsets of respondents, so major themes are identified to describe, explain or predict the phenomenon under study. Babchuk 33 provides a step-by-step guidance for qualitative analysis in this issue. When conducting a single case study, the within-case analysis yields an in depth, thick description of the case. When the study involves multiple cases, the cross-comparison analysis elicits a description of similarities and divergence between cases and may generate explanations and theoretical predictions regarding other cases. 26

For the quantitative part of the case study, data are entered in statistical software packages for conducting descriptive or inferential analysis. Guetterman 34 provides a step-by-step guidance on basic statistics. In case study designs where both data strands are analysed simultaneously, analytical techniques include pattern matching, explanation building, time-series analysis and creating logic models (p142–167). 3

Step 9. Write the case study report

The case study report should have the following three characteristics. First, the description of the case and its context should be sufficiently comprehensive to allow the reader to understand the complexity of the phenomena under study. 35 Second, the data should be presented in a concise and transparent manner to enable the reader to question, or to re-examine, the findings. 36 Third, the report should be adapted to the interests and needs of its primary audience or audiences (eg, academics, practitioners, policy-makers or funders of research). Yin 3 suggests six formats for organising case study reports, namely linear-analytic, comparative, chronological, theory building, suspense and unsequenced structures. To facilitate case transferability and applicability to other similar contexts, the case study report must include a detailed description of the case.

Step 10. Appraise quality

Although presented as the final step of the case study process, quality appraisal should be considered throughout the study. Multiple criteria and frameworks for appraising the quality of case study research have been suggested in the literature. Yin 3 suggests the following four criteria: construct validity (ie, the extent to which a study accurately measures the concepts that it claims to investigate), internal validity (ie, the strength of the relationship between variables and findings), external validity (ie, the extent to which the findings can be generalised) and reliability (ie, the extent to which the findings can be replicated by other researchers conducting the same study). Yin 37 also suggests using two separate sets of guidelines for conducting case study research and for appraising the quality of case study proposals. Stake 4 presents a 20-item checklist for critiquing case study reports, and Creswell and Poth 38 and Denscombe 39 outline a number of questions to consider. Since these quality frameworks have evolved from different disciplinary and philosophical backgrounds, the researcher’s approach should be coherent with the epistemology of the study. Figure 2 provides a quality appraisal checklist adapted from Creswell and Poth 38 and Denscombe. 39

Checklist for evaluating the quality of a case study. 38 39

The challenges to conducting case study research include rationalising the literature based on literature review, writing the research questions, determining how to bound the case, and choosing among various case study purposes and designs. Factors held in common with other methods include analysing and presenting the findings, particularly with multiple data sources.

Other resources

Resources with more in depth guidance on case study research include Merriam, 17 Stake 4 and Yin. 3 While each reflects a different perspective on case study research, they all provide useful guidance for designing and conducting case studies. Other resources include Creswell and Poth, 38 Swanborn 2 and Tight. 40 For mixed methods case study designs, Creswell and Clark, 27 Guetterman and Fetters, 21 Luck et al , 6 and Plano Clark et al 41 provide guidance. Byrne and Ragin’s 42 The SAGE Handbook of Case-Based Methods and Mills et al ’s 43 Encyclopedia of case study research provide guidance for experienced case study researchers.

• Conclusions

Family medicine and community health researchers engage in a wide variety of clinical, educational, research and administrative programmes. Case study research provides a highly flexible and powerful research tool to evaluate rigorously many of these endeavours and disseminate this information.

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A Milestone for Promoting Research in Family Medicine

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On October 30, 2023, the Association of Departments of Family Medicine (ADFM) and the NAPCRG convened a national summit to advance the next generation of plans to develop research in the specialty of family medicine. The product of 3 years of planning, with extensive input from the specialty, this extraordinary gathering was not merely an event, it was a catalyst for change, a celebration of unity, and a testament to our collective dedication to the discipline of family medicine. What follows reports the context, rationale, and next steps of this milestone to the wider community.

• Why and Why Now?

Our specialty does tribal gatherings. From the 1960s to the Future of Family Medicine to the Starfield Summits, when the problems are big and all hands are needed on deck, we come together for inspiration, for dialogue, and to set our path forward together. This summit was one of those events.

Fifty years ago, we came together as a specialty of counterculture. Our commitment was to create a new kind of doctor, a family physician, who could provide access to care across all communities. We grew residencies at light speed and are now the dominant primary care specialty with over 105,000 family physicians and now the most rapidly growing number of residencies of any specialty over the last 5 years.

As successful as our founding was, however, it bore the seeds of our current challenges with respect to research. Family medicine represented a rebellion against the medical establishment and against traditional academic centers and the test-tube science of the era. Family medicine faculty became largely a tribe of clinician teachers—very valuable for creating a new workforce, but not focused on the systematic development of research capacity. And that culture has continued. For example, for many years, drawing on the observation that research-intensive medical schools often produce fewer family physicians, many in our specialty concluded that research should not be an emphasis of the specialty. Yet the science of today is far removed from that of the 1960s. The intellectual disciplines that undergird family medicine, such as clinical epidemiology, management, and health behavior, have come of age: the potential for research relevant to what we do is much greater.

And now is a critical time for action. Despite pervasive rhetoric of “innovation” and “transformation,” and despite continuing rapid increases in cost, US health outcomes at the population level are now getting worse. We are sicker and die early. For all ages, and for almost all diseases, Americans have worse outcomes than in all other affluent countries. 1 Our life expectancy has been dropping since 2014, 2 and COVID-19 has reminded us again that care and outcomes are unequal across race and income—and now, post COVID, our practices are fighting for survival with huge demand, staff shortages and poor reimbursement. This is a much broader issue than family medicine, of course, but we believe that family physicians, well trained and supported by the system, can help heal health and health care. That has been the focus of our major redesign of residencies 3 and substantial advocacy at the federal and state levels. 4

But it is research that will drive what we do in practice and how far we will go in the future—the kind of research that informs improvement of practice and advancement of policy. But our research infrastructure is not yet robust enough to lead this process. As a specialty, our research punches far below the weight of our clinical role. Primary care represents by far the largest care delivery system in the United States, providing more than one-half of approximately a billion health care encounters a year, but receiving only .3% of NIH funding or $3 out of every $1,000 spent in NIH research. 5 We have family medicine departments which do substantial and excellent research, but there are many individual departments of internal medicine that have more research funding and more publications than our entire specialty . Moreover, the number of family physicians interested in getting advanced research training is now the lowest in a generation, with our most competitive residency programs unable to attract family physicians to research careers. And, as the wheel of fortune has turned again towards health care reform, too few family physicians with outstanding research track records have been available to compete for leadership roles in government and philanthropies.

This is not to say that we have been idle in developing research and training infrastructure. Confronting very challenging financing and cultural barriers, the specialty has tried to bootstrap itself on a number of occasions—the work of Carol Bland, Family Medicine for America’s Health, ongoing work in research-ready large databases like PRIME, 6 reporting standards for primary care research, 7 and the ongoing work of the Building Research Capacity initiative. 8 We must build on this work, even as we expand it, broaden the focus, and rethink strategy.

• The Goals of the Summit

ADFM and NAPCRG are sharing responsibility for developing the research strategy for our specialty, building on what we’ve done in the past and coordinating with other organizations in family medicine, with a clear understanding that this will be a long-term project. Over the last year, they have led 2 national meetings of leaders of family medicine organizations focused on strategy for research and, as summarized in Table 1 , conducted scores of interviews, focus groups, and a national survey. The process identified has 3 areas of focus for building research in the specialty: building pathways and mentorship programs to develop researchers, creation of new kinds of research infrastructure, and advocacy for funding of research that matters to family medicine practice and policy. The goal of the summit was to finalize the goals for each of these areas.

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Participants in the Research Summit Process

Our specialty has many wise voices to learn from, but it may be helpful to suggest what might be goals for this work. A first goal is simple to say: our community should produce the evidence needed to drive practice change. This is not the case now: as an example, over the last 2 years, the ABFM National Journal Club has screened scores of journals for empirical articles that are relevant to family medicine, likely to impact practice and methodologically sound. Of the first 249 selected, only one has a first author from a department of family medicine and only 4 have any author from a family medicine department. Similarly, as we advocate for health reform and battle with payers and big tech, and as we develop interventions to improve health equity, much of the data that drives our proposals should come from our research.

To create the research we need, however, we need to build a strong cadre of young family physicians and aspiring researchers from different backgrounds who are dedicated to making meaningful impact in clinical care and policy. This starts with attracting students passionate about research into family medicine. It entails nurturing clinical curiosity early in medical school, equipping clerkship students and residents with skills in using evidence and collecting and interpretating data. In residency and beyond, we should have clear pathways and recognition for individuals who choose to dedicate their lives and lifestyles to research. Finally, we must recruit individuals from diverse backgrounds, including those with PhDs and expertise in other clinical disciplines, who share our vision of advancing primary care and population health outcomes. The future of research is “team science” and we need teammates!

We must also evolve our research infrastructure. Traditional research training programs like the Robert Wood Johnson Clinical Scholars and HRSA-funded research training programs need modern successors; models from Canada and Europe may help guide the way. 10 Infrastructure also means developing research-ready big data sources and new methodologies while focusing on areas of potential strength in spaces such as health equity. We also need new organizational structures such as inter-institutional collaborations with large and diverse populations capable of supporting the research teams necessary for asking and answering questions that matter for primary care practice and population health.

Success will depend on effective advocacy, at both the institutional and national levels. Within academic centers, we must skillfully negotiate chair packages and uncover often hidden sources of funding. At the national level, we must advocate for the establishment of an NIH office dedicated to primary care research—this has been a successful strategy of other disciplines like emergency medicine and nursing. Let us unite in making a data-driven case for why the need for primary care research is not being met by current NIH work—and what our research priorities should be. Complementing NIH clinical research should be an expansion of AHRQ research on improving the systems of care in primary care and health care systems. Of course, effective advocacy demands good ideas, well-articulated identification of champions, both in politics and the research community, along with organization, the ability to adapt and … patience.

ADFM and NAPCRG are committed to communication and coordination with the specialty: they will be following up soon with the results of the summit, along with developing detailed plans, metrics for success and timelines. They are also preparing a series of papers that will lay out what we have learned and make the case for where we should go. These will be published in a special issue of JABFM next year.

The work ahead will be challenging, requiring new ideas, leadership, detailed planning, and coordination across the family of family medicine organizations. It will require clear thinking about practicality and the discipline to maintain. And it will require tenacity: this is at least a 5- to 10- year effort.

In conclusion, almost 20 years ago, the authors of the Future of Family Medicine report declared: “Unless there are changes in the broader health care system and within the specialty, the position of family medicine in the United States will be untenable in a 10- to 20-year time frame.” 7 Since then, we have made significant progress, but there is much still left to do. An important part of our unfinished business is making research integral to our specialty and to our culture—as well as bringing about changes in broader health care and research ecosystems.

The stakes are high. Thank you to all who are bringing ideas and energy to this effort. Like residency redesign, it is one of the major tasks of our generation.

• © 2023 Annals of Family Medicine, Inc.
• 1. ↵ US Health in International Perspective: Shorter Lives, Poorer Health . National Research Council and Institute of Medicine of the National Academies ; 2013 .
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Family Medicine Updates

Similar articles.

ROLAND GRAD, MD, MSc, AND MARK H. EBELL, MD, MS

Am Fam Physician. 2021;104(1):41-48

Related letter: Should Muscle Relaxants Be Used as Adjuvants in Patients With Acute Low Back Pain?

Published online June 9, 2021.

Author disclosure: Dr. Grad has no relevant financial affiliations. Dr. Ebell is cofounder and editor-in-chief of Essential Evidence Plus; see Editor's Note.

This article summarizes the top 20 research studies of 2020 identified as POEMs (patient-oriented evidence that matters), including the two most highly rated guidelines of the year on gout and chronic obstructive pulmonary disease (COPD). Regarding COVID-19, handwashing and social distancing through stay-at-home orders or quarantine measures are effective at slowing the spread of illness. Use of proper face masks (not gaiters or bandanas) is also effective at preventing transmission. This is important because the virus can infect others during the presymptomatic phase. Aspirin can no longer be recommended for the primary prevention of cardiovascular disease. Human papillomavirus vaccination is strongly associated with reduced risk of invasive cervical cancer, especially in women who were vaccinated before 17 years of age. When a woman who is postmenopausal has a screening bone mineral density test, rechecking the test after three years does not help to identify those who will have a fragility fracture. A higher daily step count is associated with lower all-cause mortality. After one year of follow-up, physical therapy is preferred to glucocorticoid injections for osteoarthritis of the knee; acetaminophen is ineffective for acute low back pain or pain due to knee or hip osteoarthritis; and adding a muscle relaxant to ibuprofen does not improve functional outcomes or pain in people reporting moderate to severe back pain one week after starting treatment. Although short-term antibiotics and steroids are effective in treating acute exacerbations of COPD, not much else is. Successful communication with patients seeking an antibiotic for a flulike illness can be achieved with combinations of messaging, including information on antibiotic resistance and the self-limiting nature of the illness. A new prediction rule effectively identifies patients with a history of penicillin allergy who have a low likelihood of positive findings on allergy testing. Low-value screening tests in asymptomatic, low-risk patients often lead to further testing, diagnostic procedures, or referrals. A new tool helps determine the amount of change needed to signify a real difference between two laboratory values in the same person over time. Finally, a pillar of our specialty, continuity of care, is associated with decreased all-cause mortality.

Annually for 22 years, a team of clinicians has systematically reviewed English-language medical journals to identify original research most likely to change and improve primary care practice. The team includes experts in family medicine, pharmacology, hospital medicine, and women's health. 1 , 2

The goal of this process is to identify POEMs (patient-oriented evidence that matters). A POEM must report at least one patient-oriented outcome, such as improvement in symptoms, morbidity, or mortality. It should also be free of important methodologic bias, making the results valid and trustworthy. Finally, if applied in practice, the results would change what some physicians do by prompting them to adopt a new practice or discontinue an old one that has been shown to be ineffective or harmful. Adopting POEMs in clinical practice should improve patient outcomes. Of more than 20,000 research studies published in 2020 in the journals reviewed by the POEMs team, 306 met criteria for validity, relevance, and practice change. These POEMs are emailed daily to subscribers of Essential Evidence Plus (Wiley-Blackwell, Inc.).

The Canadian Medical Association purchases a POEMs subscription for its members, many of whom receive the daily POEM. As these physicians read a POEM, they can rate it using a validated questionnaire. This process is called the Information Assessment Method ( https://www.mcgill.ca/iam ). POEM ratings address the domains of clinical relevance, cognitive impact, use of this information in practice, and expected health benefits if that POEM is applied to a specific patient. 3 , 4 In 2020, each of the 306 daily POEMs was rated by an average of 1,230 physicians.

In this article, we present the 20 most clinically relevant POEMs as rated by Canadian Medical Association members in 2020. This is the 10th installment of our annual series ( https://www.aafp.org/afp/toppoems ). As we write this article, the pandemic rolls on. However, beyond COVID-19, our patients continue to face the usual (and unusual) health problems of everyday life. Thus, we summarize the clinical question and bottom-line answer for research studies identified as a top 20 POEM, organized by topic and followed by a brief discussion. This set of 20 POEMs includes the two most relevant practice guidelines of the year. The full POEMs are available online at https://www.aafp.org/afp/poems2020 .

The year 2020 saw the emergence of SARS-CoV-2, a novel coronavirus that causes the COVID-19 illness, and 54 POEMs addressed the epidemiology, diagnosis, treatment, and prognosis of patients with COVID-19. Not surprisingly, the four most highly rated POEMs of the year and five in the top 20 provided evidence regarding preventive measures ( Table 1 ) . 5 – 10 These were published early in the pandemic and provided important evidence for family physicians to share with their patients.

The most highly rated POEM was originally published in 2015 and reissued in 2020 after the content was updated for COVID-19. The study was a large pragmatic trial in the United Kingdom that randomized participants to a brief online hand-washing intervention or usual care. Those who completed the intervention had fewer respiratory tract infections over the next four months (51% vs. 59%; P < .001; number needed to treat = 12). 5

The next COVID-19 POEM was a Cochrane review. 6 The authors reviewed the results of modeling studies of COVID-19 and previous coronavirus pandemics, as well as four observational studies. They concluded that quarantine measures are effective in slowing the spread of infection, especially when implemented early and in conjunction with other public health measures.

The third POEM summarized the results of two ecologic studies. The first compared COVID-19 incidence rates in eight Iowa counties that did not have stay-at-home orders with seven neighboring Illinois counties that had such orders in place. 7 The second compared a Georgia county that implemented stay-at-home orders approximately two weeks before the rest of Georgia with seven surrounding counties. 8 In both studies, earlier implementation of stay-at-home orders was associated with a lower incidence of COVID-19.

Another POEM summarized the results of one of the earliest studies to evaluate the effectiveness of different kinds of masks for preventing the spread of respiratory droplets. 9 Using laser technology, 14 types of masks were evaluated. Gaiters and bandanas were essentially useless, polypropylene and surgical masks were much better, and N95 masks were best.

An important factor in the rapid spread of COVID-19 was transmission by asymptomatic people. One of the first publications to report this was described in the next POEM. Chinese researchers studying infector-infectee transmission pairs found that the peak of infectiousness occurs about one day before symptom onset, and that 44% of secondary cases occur during the presymptomatic period. 10 Another study (not among the top 20 POEMs) reviewed cohorts in which the entire group was tested for COVID-19 during an outbreak and found that the rates of asymptomatic or presymptomatic infection are 75% or higher in young adult populations and approximately 40% overall. 11

Prevention and Screening

POEMs addressing prevention topics are summarized in Table 2 . 12 – 15 The first was a meta-analysis of randomized trials comparing aspirin with placebo as primary prevention. It compared four studies that recruited patients since 2005, with older studies that largely recruited patients in the 1980s and 1990s. The newer studies no longer found that patients taking aspirin for primary prevention have significant reductions in cancer incidence or mortality, cardiovascular mortality, or nonfatal myocardial infarction. Any benefits were countered by harms, such as increased gastrointestinal bleeding. 12 Perhaps we are doing a better job of screening for cancer and preventing cardiovascular events through use of statins and antihypertensives, lessening the need for aspirin in prevention.

We often tell our patients to walk more, but does walking affect mortality? The next POEM used data from a national sample of U.S. residents whose daily steps were measured between 2003 and 2006. 13 All-cause mortality was 77 per 1,000 person-years for those with less than 4,000 steps per day; 21 per 1,000 for those with 4,000 to 7,999 steps per day; 7 per 1,000 for those with 8,000 to 11,999 steps per day; and 4.8 per 1,000 for those with at least 12,000 steps per day. Step intensity was not significantly associated with mortality after controlling for total daily steps. Bottom line? Higher step counts are associated with lower all-cause mortality, suggesting our patients should keep walking. 13

When a woman who is postmenopausal has a screening bone mineral density test, the question arises about whether to repeat the test and, if so, how often? The third POEM in this group is a cohort study from the Women's Health Initiative, which showed that information gained from a second test three years after the first does not add predictive value beyond the first test result. Because bone density changes little over time, one bone mineral density test at around 65 years of age is likely to be sufficient for the purpose of screening to prevent a fragility fracture. 14

Studies have shown that human papillomavirus (HPV) vaccination can reduce the likelihood of precancerous abnormalities identified on a Papanicolaou (Pap) test. The next POEM is a Swedish study that used data from a national health registry to compare the risk of invasive cervical cancer in 527,871 vaccinated women vs. 1,145,112 unvaccinated women. 15 After adjusting for differences between groups, the incidence rate ratio (IRR; the ratio of the incidence of cancer in vaccinated people to that in unvaccinated people) for invasive cervical cancer was 0.37 (95% CI, 0.21 to 0.57). For women who were vaccinated before 17 years of age, the IRR was only 0.12 (95% CI, 0.00 to 0.34), whereas for those vaccinated between 17 and 30 years of age, the IRR was 0.47 (95% CI, 0.27 to 0.75). HPV vaccination is strongly associated with a lower risk of invasive cervical cancer, especially when given early.

Musculoskeletal

Three POEMs addressing musculoskeletal topics are summarized in Table 3 . 16 – 19 The first is a study that randomized adults with knee osteoarthritis to up to three corticosteroid injections or up to eight physical therapy sessions in the first six weeks, with additional sessions as needed. 16 The rapid and large improvement in the first month for both groups is somewhat surprising, with relatively little further improvement the rest of the year. This suggests regression to the mean may have contributed to the observed improvement (i.e., patients were identified when their arthritis was flaring up and would have improved no matter what). Also, the open-label design may have contributed to a Hawthorne effect (alteration of behavior by the participants of a study who know they are being observed) for those in the physical therapy group and a placebo effect for those in the injection group. A Cochrane review concluded that glucocorticoid injections are effective, although primarily in the two to four weeks following injection. 17 Overall, the physical therapy group did better at one year, with continued improvement, whereas the injection group plateaued after the first month. 16

The next POEM is a systematic review of randomized controlled trials of acetaminophen compared with placebo for pain relief in adults. 18 It showed that acetaminophen is more effective than placebo in providing some pain relief in patients with acute migraine and might be more beneficial than placebo (which also works well) for tension headaches. A single dose of acetaminophen is about twice as likely as placebo to reduce postpartum perineal pain, and it may be effective (but not as effective as other treatments) for acute renal colic. Importantly, acetaminophen is ineffective for patients with acute low back pain or pain due to knee or hip osteoarthritis.

The last POEM in this category addresses a drug class often prescribed for back pain. In people with moderate to severe low back pain who are taking a nonsteroidal anti-inflammatory drug, such as ibuprofen (up to 600 mg three times per day), does the addition of a muscle relaxant improve function or reduce pain? No. 19 This finding reminds us of an earlier randomized controlled trial from the same author that was a top POEM of 2015. At that time, we advised not adding cyclobenzaprine to naproxen for patients with acute low back pain. 20

Respiratory

Two top POEMs on respiratory topics are summarized in Table 4 . 21 , 22 One is a meta-analysis of randomized controlled trials of treatment in patients with an exacerbation of chronic obstructive pulmonary disease. 21 This shows that antibiotics and corticosteroids are effective in treating acute exacerbations in outpatient and inpatient settings, regardless of the severity of the exacerbation. Current research does not provide good guidance on which antibiotic is best or on the optimal dose or duration of corticosteroid treatment. Notably, studies performed in critically ill patients were not included in this analysis.

The other POEM addresses the tricky issue of communicating with patients who appear to be seeking an antibiotic for a flulike illness. It is a randomized trial conducted online in the United Kingdom showing that patients receiving the combination of a fear-based message about increased antibiotic resistance and an empowering message are less likely to visit a physician for their next respiratory tract infection (45.1% to 46.1% vs. 29.2%; P < .001) and less likely to request an antibiotic (52.5% to 54.7% vs. 42.3%; P < .001) than those receiving only fear-based messaging. 22

Miscellaneous

Four top POEMs do not fall easily into a single category ( Table 5 ) . 23 – 26 The first is about a new clinical prediction rule to identify patients who report a penicillin allergy but are unlikely to have a true allergy if tested. The FAST rule is as follows—five years or less since the reaction: 2 points; anaphylaxis, angioedema, or severe cutaneous reaction: 2 points; treatment required for reaction: 1 point. Patients with a score of 0 have a less than 1% likelihood of a positive result on allergy testing, and those with a score of 1 or 2 have a 5% likelihood. 23

The COVID-19 pandemic upended medical practice, leading to large reductions in the use of health care services. For example, the Canadian Urological Association recommended the cessation of prostate-specific antigen screening for prostate cancer until the resolution of the pandemic. 27 In this context, the next POEM reminds us to avoid low-value screening tests in asymptomatic, low-risk patients because they often lead to further testing, diagnostic procedures, or referrals. 24 Specifically, screening tests in low-risk patients, such as chest radiography and electrocardiography in adults as part of an annual health examination and Pap tests in those younger than 21 years or older than 69 years, should be avoided.

How many patients still ask for annual blood tests despite physicians counseling them on the low yield for doing this? The next POEM was the top non–COVID-related POEM of 2020 for clinical relevance. 25 This POEM describes a new online tool ( https://www.bmj.com/content/368/bmj.m149 ) to illustrate the variability in a single laboratory value (such as the A1C test) and the amount of change needed to signify a real difference between two values in the same person over time. For example, given the variability inherent in total cholesterol measurements, it is difficult to detect a clinically important change within a one-year period.

Our final miscellaneous POEM is a systematic review of the value of a pillar of family medicine—personal continuity of care. This is defined by an ongoing relationship with a physician that builds the physician-patient relationship and promotes the healing power of interactions. This core principle of family medicine stands up to scientific scrutiny by demonstrating an associated reduction in mortality. 26

Practice Guidelines

POEMs sometimes summarize high-impact clinical practice guidelines. Key messages from the two highest rated guidelines, addressing gout and chronic obstructive pulmonary disease, are summarized in Table 6 . 28 , 29

The full text of the POEMs discussed in this article is available at https://www.aafp.org/afp/poems2020 .

A list of top POEMs from previous years is available at https://www.aafp.org/afp/toppoems .

Editor's Note: This article was cowritten by Dr. Mark Ebell, deputy editor for evidence-based medicine for AFP and cofounder and editor-in-chief of Essential Evidence Plus, published by Wiley-Blackwell, Inc. Because of Dr. Ebell's dual roles and ties to Essential Evidence Plus, the concept for this article was independently reviewed and approved by a group of AFP 's medical editors. In addition, the article underwent peer review and editing by three of AFP 's medical editors. Dr. Ebell was not involved in the editorial decision-making process.—Sumi Sexton, MD, Editor-in-Chief

The authors thank Wiley-Blackwell, Inc., for giving permission to excerpt the POEMs; Drs. Allen Shaughnessy, Henry Barry, David Slawson, Nita Kulkarni, and Linda Speer for selecting and writing the original POEMs; the academic family medicine fellows and faculty of the University of Missouri–Columbia for their work as peer reviewers; Joulé, Inc., for supporting the POEMs CME program in Canada; Pierre Pluye, PhD, for codeveloping the Information Assessment Method; and Maria Vlasak for her assistance with copyediting the POEMs.

Shaughnessy AF, Slawson DC, Bennett JH. Becoming an information master: a guidebook to the medical information jungle. J Fam Pract. 1994;39(5):489-499.

Ebell MH, Barry HC, Slawson DC, et al. Finding POEMs in the medical literature. J Fam Pract. 1999;48(5):350-355.

Grad RM, Pluye P, Mercer J, et al. Impact of research-based synopses delivered as daily e-mail: a prospective observational study. J Am Med Inform Assoc. 2008;15(2):240-245.

Pluye P, Grad RM, Johnson-Lafleur J, et al. Evaluation of email alerts in practice: part 2. Validation of the information assessment method. J Eval Clin Pract. 2010;16(6):1236-1243.

Little P, Stuart B, Hobbs FDR, et al. An internet-delivered handwashing intervention to modify influenza-like illness and respiratory infection transmission (PRIMIT): a primary care randomised trial [published correction appears in Lancet . 2015;386(10004):1630]. Lancet. 2015;386(10004):1631-1639.

Nussbaumer-Streit B, Mayr V, Dobrescu AI, et al. Quarantine alone or in combination with other public health measures to control COVID-19: a rapid review. Cochrane Database Syst Rev. 2020(4):CD013574.

Lyu W, Wehby GL. Comparison of estimated rates of coronavirus disease 2019 (COVID-19) in border counties in Iowa without a stay-at-home order and border counties in Illinois with a stay-at-home order. JAMA Netw Open. 2020;3(5):e2011102.

Ebell MH, Bagwell-Adams G. Mandatory social distancing associated with increased doubling time: an example using hyperlocal data. Am J Prev Med. 2020;59(1):140-142.

Fischer EP, Fischer MC, Grass D, et al. Low-cost measurement of face mask efficacy for filtering expelled droplets during speech. Sci Adv. 2020;6(36):eabd3083.

He X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19 [published correction appears in Nat Med . 2020;26(9):1491–1493]. Nat Med. 2020;26(5):672-675.

Oran DP, Topol EJ. Prevalence of asymptomatic SARSCoV-2 infection: a narrative review. Ann Intern Med. 2020;173(5):362-367.

Moriarty F, Ebell MH. A comparison of contemporary versus older studies of aspirin for primary prevention. Fam Pract. 2020;37(3):290-296.

Saint-Maurice PF, Troiano RP, Bassett DR, et al. Association of daily step count and step intensity with mortality among US adults. JAMA. 2020;323(12):1151-1160.

Crandall CJ, Larson J, Wright NC, et al. Serial bone density measurement and incident fracture risk discrimination in postmenopausal women. JAMA Intern Med. 2020;180(9):1232-1240.

Lei J, Ploner A, Elfström KM, et al. HPV vaccination and the risk of invasive cervical cancer. N Engl J Med. 2020;383(14):1340-1348.

Deyle GD, Allen CS, Allison SC, et al. Physical therapy versus glucocorticoid injection for osteoarthritis of the knee. N Engl J Med. 2020;382(15):1420-1429.

Jüni P, Hari R, Rutjes AWS, et al. Intra-articular corticosteroid for knee osteoarthritis. Cochrane Database Syst Rev. 2015(10):CD005328.

Saragiotto BT, Abdel Shaheed C, Maher CG. Paracetamol for pain in adults. BMJ. 2019;367:l6693.

Friedman BW, Irizarry E, Solorzano C, et al. A randomized, placebo-controlled trial of ibuprofen plus metaxalone, tizanidine, or baclofen for acute low back pain. Ann Emerg Med. 2019;74(4):512-520.

Friedman BW, Dym AA, Davitt M, et al. Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: a randomized clinical trial. JAMA. 2015;314(15):1572-1580.

Dobler CC, Morrow AS, Beuschel B, et al. Pharmacologic therapies in patients with exacerbation of chronic obstructive pulmonary disease: a systematic review with meta-analysis. Ann Intern Med. 2020;172(6):413-422.

Roope LSJ, Tonkin-Crine S, Herd N, et al. Reducing expectations for antibiotics in primary care: a randomised experiment to test the response to fear-based messages about antimicrobial resistance. BMC Med. 2020;18(1):110.

Trubiano JA, Vogrin S, Chua KYL, et al. Development and validation of a penicillin allergy clinical decision rule. JAMA Intern Med. 2020;180(5):745-752.

Bouck Z, Calzavara AJ, Ivers NM, et al. Association of low-value testing with subsequent health care use and clinical outcomes among low-risk primary care outpatients undergoing an annual health examination. JAMA Intern Med. 2020;180(7):973-983.

McCormack JP, Holmes DT. Your results may vary: the imprecision of medical measurements. BMJ. 2020;368:m149.

Baker R, Freeman GK, Haggerty JL, et al. Primary medical care continuity and patient mortality: a systematic review. Br J Gen Pract. 2020;70(698):e600-e611.

Kokorovic A, So AI, Hotte SJ, et al. A Canadian framework for managing prostate cancer during the COVID-19 pandemic: recommendations from the Canadian Urologic Oncology Group and the Canadian Urological Association. Can Urol Assoc J. 2020;14(6):163-168.

FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout [published correction appears in Arthritis Rheumatol . 2021;73(3):413]. Arthritis Rheumatol. 2020;72(6):879-895.

Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society Clinical Practice Guideline [published correction appears in Am J Respir Crit Care Med. 2020;202(6):910]. Am J Respir Crit Care Med. 2020;201(9):e56-e69.

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• Open access
• Published: 20 August 2024

Advice to future family physicians: findings from qualitative interviews with family medicine residents and early-career family physicians

• Sean Wang 1 ,
• Richard Buote 1 ,
• Lauren R. Moritz 1 ,
• M. Ruth Lavergne 1 &
• Emily Gard Marshall 1  

BMC Medical Education volume  24 , Article number:  897 ( 2024 ) Cite this article

Metrics details

Canadians continue to report challenges accessing primary care. Practice choices made by primary care providers shape services available to Canadians. Although there is literature observing family medicine practice trends, there is less clarity on the reasoning underlying primary care providers’ practice intentions. Advice offered by residents and early-career family physicians may reveal challenges they have experienced, how they have adapted to them, and strategies for new residents. In this paper, we examine advice family medicine residents and early-career family physicians would give to new family medicine residents.

Sixty early-career family physicians and thirty residents were interviewed as part of a mixed-methods study of practice patterns of family medicine providers in Canada. During qualitative interviews, participants were asked, “what advice would you give [a new family medicine resident] about planning their career as a family physician?” We inductively analyzed responses to this question.

Advice consisted of understanding the current climate of family medicine (need for specialization, business management burden, physician burnout) and revealed reasons behind said challenges (lack of support for comprehensive clinic care, practical limitations of different practice models, and how payment models influence work-life balance). Subtheme analyses showed early-career family physicians being more vocal on understanding practical aspects of the field including practice logistics and achieving job security.

Most advice mirrored current changes and challenges as well as revealing strategies on how primary care providers are handling the realities of practicing family medicine. Multi-modal systemic interventions may be needed to support family physicians throughout the changing reality of family medicine and ensure family medicine is an appealing specialty.

Peer Review reports

Primary care access is essential to ensure good population health outcomes and reduce health disparities [ 1 ]. Within the Canadian health system, primary care providers, such as family physicians, are the first point of contact, acting as “gatekeepers” to other aspects of the healthcare system, including specialist care [ 2 , 3 , 4 ]. However, Canadians increasingly report challenges accessing primary care, shown by a steady increase in the number of Canadians without a regular primary care provider [ 5 , 6 ]. Strains on primary care appear to have worsened during the COVID-19 pandemic, with higher numbers of family physicians leaving their practice during the pandemic compared to pre-pandemic. [ 7 ] There is a need to understand what is driving challenges in primary care access and influencing the choices made by primary care providers.

Over the past several decades, there have been substantial changes in practice patterns among family physicians. Compared to 1997/1998, today’s practicing family physicians have fewer contacts with patients, and fewer family physicians provide comprehensive primary care [ 8 , 9 , 10 ]. A variety of factors (e.g., health policy, patient population, practice setting, advice received as a trainee) [ 11 , 12 ] may influence these practice patterns. While we have examined current practice trends in family medicine, there is less clarity on how and why primary care providers are adapting to the practice environment in different ways. The experiences of family medicine residents and early-career family physicians and the advice they would offer to people entering residency programs may provide insight into factors shaping practice intentions and choices and, by extension, access to primary care [ 13 ].

Advice given by experienced family physicians to trainees at pivotal decision-making stages may shape practice decisions and trajectories of these learners, including scope of practice and academic involvement [ 12 , 14 ]. Advice can also prepare trainees for the realities of managing a practice, readying them for making logistical, fiscal, and human resource decisions [ 15 ]. In this study, we examine the types of advice early-career family physicians and family practice residents would offer to new family medicine residents. Findings from this study may provide insight into the existing challenges in family medicine and how these challenges may be shaping practice intentions.

Study design and population

We analyzed a subset of qualitative interview data from a larger mixed-methods study ( Practice patterns among early-career primary care physicians [ECPC] ) which explored factors contributing to practice intentions of early-career family physicians and family medicine residents across three Canadian provinces: British Columbia (BC), Ontario (ON), and Nova Scotia (NS). The complete study protocol has been published previously [ 16 ].

Participants were recruited via provincial medical association newsletters, family medicine residency programme email lists, and social media (Twitter and Facebook). To be included in the study, participants had to be a current family medicine resident or a family physician who had completed their family medicine residency between 2008 and 2018 and were currently practicing. Only those practicing in BC, ON, or NS were eligible. Prospective study participants completed a demographic screening questionnaire to ensure they met the inclusion criteria for the study. This questionnaire (Appendix 1 ) also served to facilitate diverse purposeful sampling based upon previously identified characteristics (i.e., gender, rurality, specialization, practice/training location, practice type/model, relationship status, and whether they have dependents) [ 16 ]. During recruitment, 359 residents and family physicians completed the demographic screening questionnaire. To ensure maximum variation, of those who completed the questionnaire, 32 family medicine residents and 69 early-career family physicians were purposively selected to participate in the study based on their responses to the screening questionnaire. Interviews were completed with 31 of 32 family medicine residents and 63 of 69 early-career family physicians invited to participate across the three Canadian provinces. Seven interviews were declined due to scheduling conflicts, lack of response, or an undisclosed reason. Participants were offered an honorarium.

Data collection

Semi-structured, ~ 1-hour, in-depth telephone interviews (Appendix 2 ) were conducted to understand the practice patterns and motivations of early-career family physicians and family medicine residents in BC, ON, and NS. Interviews were conducted by experienced qualitative interviewers (one per province), at a time suitable for participants, thereby engaging more geographically diverse interviewees with lower overall costs. Interviews were audio-recorded and transcribed verbatim, removing personally identifiable information.

Data analysis

Data were coded according to a robust coding framework developed by three experienced qualitative research analysts and supported by the principal investigators for the study. For the purpose of this paper, thematic analysis was performed by two analysts on the code “advice given to residents,” which corresponded to the interview question; “If you were mentoring a new family medicine resident , what advice would you give them about planning their career as a family physician?” Relevant excerpts were reviewed and analyzed independently by two analysts (SW, LRM), who identified initial themes. Refinements were made to the initial themes through discussion among analysts (SW, RB, LRM) and three general themes, with multiple subthemes, were agreed upon. Themes were finalized through discussion and support of all authors (SW, RB, LRM, MRL, EGM). This study was approved by the Simon Fraser University (#H18-03291), University of Ottawa (#S-05-18-776), and Nova Scotia Health Authority research ethics boards (#1023561).

Out of the 94 participants from the ECPC study, 60 early-career family physicians and 30 family medicine residents (90 total; 30 from BC, 30 from NS, 30 from ON) shared advice they could offer to family medicine residents and were included in this analysis. Table  1 shows the demographic and practice characteristics of participants. Participants practiced in a variety of settings and models. Men and women were interviewed, most of whom were partnered, and some cared for dependents (primarily children). Participants of this study did not agree for their individual data to be shared publicly, so supporting data are not available.

Family physicians and residents provided many pieces of advice to potential family medicine residents. We identified three themes in the data: (1) advice on the importance of having diverse practice experiences; (2) advice on the unanticipated aspects of family medicine; and (3) advice on taking care of yourself while practicing family medicine.

Theme 1. Advice on the importance of having diverse practice experiences

Participants who were early-career family physicians and residents emphasized the importance of experiencing a diversity of practice settings and fields. A family physician advised that residents should spend time “test[ing] the waters ” and finding “where you feel that you fit and you’re happy.” (Family Physician, BC). As one participant explained:

“I’d tell them to do as many electives in different places and experience as many different types of clinics and types of practices that they can… I never would have thought that I could be doing what I was doing. I sort of thought buying into a practice was sort of your only option… And I honestly tell people… don’t commit to something right away… there are so many opportunities out there that you’re not exposed to.” (Family Physician, BC).

Several participants recommended that residents should locum first to gain experience across a variety of family medicine models, communities, and specialties. By locuming, new physicians can “get the sense of how you want to schedule your day… You’re working with different types of administrators. You’re not having to work with your own administrators. So , you can figure out who you want to hire in a secretary or if you need more than one secretary… you get to see what it’s like either in a collaborative or a solo practice… see different areas , get different experiences as a working physician.” (Family Physician, NS).

Locum work can provide new family physicians with the opportunity to “try” out potential future practice locations “before putting roots down” (Family Physician, NS). A family physician said that residents should know “… it’s okay to locum and try out different types of models because at the end of the day , I hope that everyone can find the passion to do what they do in a model where they love how they get to practice medicine.” (Family Physician, ON).

Interviewees advised that residents seek variety in areas of practice such as emergency and obstetrics and experience practicing in rural areas, where one can “really see what the breadth of family medicine is” (Resident, ON). Experience in other areas of medicine can offer family physicians “flexibility” in their practice. As a resident said, “…you can work in a diverse number of environments… plus the operating room , palliative , long-term care , geriatrics… it’s so diverse… you just have to find as many opportunities as possible and build sort the practice you want…” (Resident, ON).

Theme 2. Advice on the unanticipated aspects of family medicine

The business of family medicine.

Participants would advise residents on areas of knowledge not necessarily taught in the formal medical school curriculum but represented the realities of working as a family physician. Family physicians and residents noted a dearth of formal education about the “business” of family medicine and described situations where they learned by doing. Advice from early-career family physician participants in our study emphasized that new family physicians need to expose themselves to “lots of learning around billing and management” (Family Physician, NS) to better perform administrative tasks revolving around their future practices (e.g., billing, insurance, contract negotiations, starting financial planning early, get occupational health and safety training, and learn how to hire and fire staff). Billing is a necessary part of family medicine for fee-for-service physicians, but is not formally taught in medical school or postgraduate training. As one participant stated, “No one taught me how to bill. That was a disaster – learning how to do that.” (Family Physician, NS). Advice was given to “… talk to preceptors that you work with and see … how do they handle hiring and firing people … how do they schedule … the logistics of being a family doctor” and “know who are support people are and who can advocate for you.” (Resident, NS).

Realities of working under different models

Interviewees not only detailed that learning the administrative duties of a family physician is critical for effectively running their family medicine practice, but they also emphasized the difficulties and limitations that come with working within the current payment and practice models offered. For instance, interviewees discussed how the business side of family medicine intersected with their well-being. For example, new family physicians might need to create time for vacation when working in solo practice, but “ You need to find somebody to cover for you in that kind of model. So yeah , I don’t know that I can fully endorse that kind of work. But I think it is the most personally and professionally valuable” (Family Physician, BC). Another interviewee suggested that new family physicians should consider how pay might influence work-life balance: “I make twice as much per hour [working in emergency medicine] as working in a clinic. So , I can work half as much and have time for myself and my wife or kids or whatever’s in the future.” (Family Physician, BC).

Not all interviewees were responsible for their own clinic, but many provided advice about the business of family medicine. Early-career family physician and resident participants in our study advised that physicians must be careful about the contracts they sign and the agreements they make. As one participant explained:

“… avoid committing yourself to any contracts … I see so many new grads being taken advantage of all the time … they’re basically taking advantage of new grads who don’t have that knowledge.” (Family Physician, BC).

Because it can be challenging to navigate the business of family medicine, a resident advised that other residents should “… not just jump into the first offer that you’re given … you want to make sure that you’re not being over-worked. You want to make sure that you’re being compensated properly… aware of your call schedule… to know who your support people are, or who can, advocate for you. So , whether that’s [your provincial professional association] , whether it’s other physicians.” (Resident, NS).

Relevancy of and support for family medicine

Family physicians and residents recommended that new residents have an awareness of the relevancy of, and support for, family medicine . Some interviewees voiced their frustration with the lower level of support family physicians receive, describing their profession as “eroding” and that residents should consider whether they want to do family medicine. As one participant explained, “ I could see it becoming less and less relevant. You know , being a generalist… That’s what I’m afraid of… So , I think I would tell them to have a back-up plan… a different skillset in medicine.” (Family Physician, NS). Thus, to prevent the erosion of the family medicine profession and ensure it remains relevant, participants were urged to “keep advocating for fee parity and improvements in family medicine” (Family Physician, BC).

Complexity of family medicine

Furthermore, participants often discussed the high and increasing complexity of family medicine. Interviewees described how family physicians are responsible for caring for increasingly complex patients “ due to the [family physician] shortage… or the long timelines to get people into specialists.” (Family Physician, NS). Because of the perceived growing expectations of family physicians, an interviewee advised that residents should “go easy on yourself” as there is a “tendency of that [frustration] in family medicine because all the problems always come back to us , ” suggesting that once specialists have exhausted all of their options, the onus falls back on the family physician to decide “now what are you going to do about it?” (Family Physician, NS).

Participants also discussed important considerations about working with patients. As one interviewee described, “… don’t… under-estimate… a patient’s knowledge of themselves even if it doesn’t fall into a guideline” (Family Physician, NS), going on to imply the importance of considering the patients’ preferences in treatment.

As one participant described, the medical complexity of family medicine requires a flexible schedule, with consideration of patients with urgent or emergent needs, “… there’s lots of surprises that come in in family medicine… you have to allow a little bit of flexibility in the schedule for urgent people you need to fit in , or people that come in with chest pain , or suicidality , or things like that. So , it’s teaching around… being flexible and giving people the time when they need it. But also teaching residents and learners that sometimes you just have to set down some ground rules with patients for their own benefit sometimes.” (Family Physician, NS).

Importance of lifelong learning

Participants also emphasized the importance of lifelong learning in family medicine, sharing that “… the minute that I think that I know everything about a subject is probably when I do something that I don’t mean to do and potentially harm a patient.” (Family Physician, ON).

One participant advised future residents to “ expect change throughout your career… [w]hether that’s government changes , whether it’s the advent of AI and technology…” (Family Physician, ON).

Perceived need to specialize within family medicine

Finally, not only were family medicine residents advised to be flexible and expect change throughout their careers, but participants also urged residents to specialize within an area of family medicine to stay afloat . As a resident explained, “I think the nature of family medicine is changing , and increasingly so , there are less and less true general practitioners. And so , if you don’t carve something out that you’re interested in , I think you kind of get lost in the shuffle” (Resident, BC). Participants recommended that residents narrow their practice into a subspecialty like “sports medicine or addictions” (Family Physician, BC) and that residents “…could apply for enhanced training skills or a plus one program to help develop those skills and make them more competitive after they’re done their training” (Resident, NS).

Theme 3. Advice on taking care of yourself while practicing family medicine

Participants offered several pieces of advice for residents to understand how to take care of themselves in family medicine . Of particular concern to participants was preventing burnout. Strategies for avoiding burnout included not “jump[ing] right into a practice” (Family Physician, BC), “find[ing] a niche… Something you can do to get a good balance in your career and so you don’t burn out.” (Resident, ON), and “… guarding… personal and private time.” (Family Physician, NS).

Many participants suggested that new family medicine residents need to prioritize work/life balance . Family physician and resident participants discussed how general, full-time family medicine can lead to little personal flexibility and dissatisfaction with work and burnout. As a participant advised, “I would tell them to design their life first and then find an area within family medicine , whether that’s clinic or otherwise , that will let them actually live the life they want. Because if you just sign up to be a doctor first , you can work endlessly and not have any time for yourself” (Family Physician, BC).

Many participants discussed difficulties managing work and personal considerations and how poor balance in these areas can result in physicians leaving the profession. Participants provided advice for residents about planning for the future, with several participants suggesting that new residents should build their practice starting smaller, including core interests and then “build from that. If you find you have room in your life , then add the second or third thing. Because it’s a lot easier to build up than it is to say no.” (Family Physician, NS). Similarly, some participants advised that residents envision their personal goals and “work backwards.” As this participant suggested, “picture where you want to be in 10 to 20 years , and then kind of plant the seeds.” (Family Physician NS). Having a mentor or role model may help with this: “… find people whose work-life balance reflects your own values. And then strive to follow a similar path.” (Family Physician, BC).

Overall, participants advised that residents should find personal satisfaction in their work and “end up with a career that you are truly passionate about and that you love” (Resident NS). As previously mentioned, there was a substantial amount of advice provided on obtaining experience in a variety of areas. One participant advised that residents should “… understand… the aspects of the work that you enjoy the most. And then you can use that to guide where you end up working. So , do you like having longitudinal relationships? Do you like quick diagnostics? Do you… like to do procedures? Do you like the complexity of working in resource-limited spaces?” (Family Physician, BC). As participants described, it is essential that residents spend time finding what they like and dislike about their job because “how am I going to be able to provide the care that I want to be able to provide to my patients without feeling angry or bitter or whatever it is about the system?” (Family Physician, ON) and “no one’s going to give you a medal at the end of 30 years for making yourself miserable.” (Family Physician, BC).

Subtheme 1. Advice comparison between providers, provinces, and genders

Responses from both residents and early-career family physicians were examined showing many similarities in the advice that they would give incoming residents. Common themes include finding work-life balance, being open-minded, becoming a mentor, finding self-fulfillment, being aware of pre-mature commitment, the need for practice specialization, importance of patient advocacy, and preventing burnout. Early-career family physicians were more likely to emphasize the importance of understanding practice logistics and achieving job security.

Between the three provinces, the advice participants would give are similar, with NS and ON emphasizing the importance of practice logistics and job security more than BC. Otherwise, all provinces gave similar advice on finding work-life balance, being open-minded, becoming a mentor, finding self-fulfillment, being aware of pre-mature commitment, the need for practice specialization, importance of patient advocacy, and preventing burnout.

Responses from both genders of participants showed commonality in discussing advice on finding work-life balance, being open-minded, becoming a mentor, finding self-fulfillment, being aware of pre-mature commitment, the need for practice specialization, the importance of understanding practice logistic, and preventing burnout. Male providers emphasized more about the importance of patient advocacy and achieving job security.

The advice early-career family physicians and family medicine residents would offer to new family medicine residents provides insight into not only the present challenges and opportunities in family medicine, but also how these factors influence their decision-making and adaptation processes in clinical practice. We found that the advice of early-career family physicians aligned with previous research, as we identified themes within our interviews such as challenges of staff management, coping with burnout, and the increased responsibility of family physicians to care for an increasingly complex patient population [ 9 , 12 , 14 ]. Importantly, our research provides new insight into the reasoning behind the these themes, including the perceived necessity for specialization within family practice, need for readiness in advancing technologies and health informatics, and advocacy for structural changes such as remuneration parity. Last, we examined differences between residents and early-career physicians. While themes of advice were similar, more emphasis was placed on practice logistics and job security by early-career physicians than residents.

Our first overarching theme of need for seeking diverse experiences in family medicine has previously been identified with fewer family physicians committing to and offering comprehensive primary care [ 13 ], and a greater number of family physicians are working under a specialized scope of practice, partitioning their practice into specific fields of interest, such as obstetrics, surgical assist, small procedures, and emergency medicine [ 11 , 13 , 16 , 26 , 27 ]. Our findings add to the current literature by demonstrating the reasoning behind this trend of specialized rather than generalized family practice; such that, family physicians may be doing this to remain competitive with respect to pay, reduce burnout with regards to schedule flexibility and evade contractual agreements that try to take advantage of new graduates [ 8 , 13 ]. The insight gained from this advice allows health system planners and decision-makers to understand the factors considered by family physicians in how they practice and address the concerns in their policy-making, thereby attracting more family physicians to practice comprehensive clinic care.

We secondly demonstrated that family physicians and residents face a practice environment that poses challenges not only with clinically complex patients [ 23 , 24 , 25 ] but also developing a detailed understanding of practice logistics and business [ 20 ]. Our participants not only identify the gaps in education on financial planning, technological advances, and compensation, but strategies in which they take to mitigate these challenges and optimize clinical care for their patients. For instance, providers can take advantage of variety of scheduling, areas of focus, and practice models [ 17 ]. A novel finding in our study shows an emphasis on seeking preceptors that act as mentors in learning business management. This demonstrates an important wealth of knowledge on the administrative practice of family medicine, as formal curriculum in such topics are not concretely implemented in training [ 15 , 16 , 21 , 22 ]. Finding mentorship from preceptors is especially important as our results demonstrate that residents are less likely to be concerned about practice logistics and job security than staff physicians. In brief, participants demonstrate that challenges endured by family physicians can be explored through taking advantage of practice flexibility and informal mentorship. Formal education may need to be more agile to train new cohorts of family physicians in a changing primary care landscape.

Family physicians and residents’ well-being and burnout prevention is a commonly identified theme in previous literature [ 14 , 18 , 19 ]. Interestingly, our interviewees recommended that in order to prevent burnout, new family physicians ought to focus on both structural and personal strategies such as start their career with a part-time practice and build up from there, designing their practice around the type of lifestyle they wish to have and ultimately practicing the aspects of family medicine they genuinely enjoy and value. However, participants noted that the current capacity of organizational and funding models available for family physicians limits their opportunities. A specific example includes being compensated fairly for their practice, with participants detailing the difficulties of specific family medicine remuneration models, such as the inflexibility of taking vacation time in a solo fee-for-service practice, or how specialized compared to general family practice is compensated relatively higher. This is supported by previous research, which suggests that fee-for-service remuneration models may discourage the practice of comprehensive family medicine [ 13 ]. Parity in pay may help family physicians feel more valued within the health system and encourage them to provide primary care services that are desperately needed within the Canadian health system [ 20 ]. It is evident that strategies to combat physician burnout is limited without policy changes to adequately fund comprehensive family practice.

In all, our study confirms previous research which found that the need for specialization, clinical complexity, burnout, and job logistics amalgamate, forming ongoing concerns for family medicine residents [ 14 ]. Not only does it emphasize these themes, it identifies motives, strategies, and reasoning behind the practice patterns and trends of current family physicians and how they adapt to current challenges and opportunities. While participants shared many positive aspects of family medicine, they focused significantly on the perils and challenges of practicing family medicine. When we are in a time of needing to increase the number of family physicians to meet the primary care needs of patients across the country, it may be important to reflect on how more experienced family physicians influence trainees away from family practice and the need to advocate for improvements in primary care such as revising formal curriculum to include non-clinical aspects of practice, parity in remuneration, and mentorship supports for new family physicians. Individual-level interventions are not enough to counter system-level challenges. Systemic interventions will be needed if system decision-makers wish to encourage greater involvement in comprehensive family medicine [ 26 , 28 , 29 , 30 ].

Advice from early-career family physicians and senior family medicine residents to new family medicine residents emphasized the importance of taking advantage of early-career opportunities, understanding the realities and complexities of modern family medicine, and advocating for personal well-being and satisfaction. Our results also revealed the strategies and decision-making behind the current family medicine curriculum and practice trends. Systemic intervention is needed to support family physicians throughout their entire careers to allow them to practice in a way that is personally and professionally fulfilling while supporting their lifelong learning in an ever-changing field.

Data availability

The datasets supporting the conclusions of this article are included within the article.

Abbreviations

British Columbia

Nova Scotia

Continuing Medical Education

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CRISPR–Cas9: A History of Its Discovery and Ethical Considerations of Its Use in Genome Editing

Irina gostimskaya.

The University of Manchester, M1 7DN Manchester, UK

The development of a method for genome editing based on CRISPR–Cas9 technology was awarded The Nobel Prize in Chemistry in 2020, less than a decade after the discovery of all principal molecular components of the system. For the first time in history a Nobel prize was awarded to two women, Emmanuelle Charpentier and Jennifer Doudna, who made key discoveries in the field of DNA manipulation with the CRISPR–Cas9 system, so-called “genetic scissors”. It is difficult to overestimate the importance of the technique as it enables one not only to manipulate genomes of model organisms in scientific experiments, and modify characteristics of important crops and animals, but also has the potential of introducing revolutionary changes in medicine, especially in treatment of genetic diseases. The original biological function of CRISPR–Cas9 system is the protection of prokaryotes from mobile genetic elements, in particular viruses. Currently, CRISPR–Cas9 and related technologies have been successfully used to cure life-threatening diseases, make coronavirus detection tests, and even to modify human embryo cells with the consequent birth of babies carrying the introduced modifications. This intervention with human germplasm cells resulted in wide disapproval in the scientific community due to ethical concerns, and calls for a moratorium on inheritable genomic manipulations. This review focuses on the history of the discovery of the CRISPR–Cas9 system with some aspects of its current applications, including ethical concerns about its use in humans.

A HISTORY OF THE DISCOVERY OF THE MAIN COMPONENTS OF THE CRISPR–Cas9 SYSTEM

CRISPR – clustered regularly interspaced short palindromic repeats – were first discovered in the sequences of DNA from Escherichia coli bacteria and described in 1987 by Ishino et al. [ 1 ] from Osaka University (Japan). At that time sequencing of these difficult-to-study DNA fragments took several months, but neither their origin nor their significance in the bacterial cell were understood by their discoverers. Although in the early work in this field, the biological function of the CRISPR system had not yet been elucidated, scientists had already proposed a way to use the information encoded in CRISPR loci in medical research, namely, for genotyping various strains of bacteria: initially on Mycobacterium tuberculosis [ 2 ], and later on Streptococcus pyogenes [ 3 ]. As it turned out, CRISPR loci had a high degree of polymorphism in different strains of the same species of pathogenic bacteria, which enabled the identification of bacterial strains in clinical conditions.

A significant breakthrough in understanding the biological function of CRISPR loci occurred with the discovery of Francisco Mojica of the University of Alicante (Spain), who came across similar structures in the archaeal genome of Haloferax mediterranei in 1995 [ 4 ]. Their presence in two evolutionarily remote domains of life suggested these elements’ great functional significance, and served as an impetus for further research. Mojica noticed the similarity of the elements he described in archaea with previously found DNA repeats in bacterial genomes, and was one of the first scientists to hypothesize that these unusual loci include fragments of foreign DNA and are, in fact, a part of the immune system of bacteria and archaea [ 5 ]. In the same year as Mojica, two other laboratories independently reached similar conclusions [ 6 , 7 ], announcing the beginning of an era of active research into this extraordinary natural phenomenon. In line with the theory of the prokaryotic immune system, viral DNA fragments (“spacers” 17-84 bases long), separated by short palindromic repeats (23-50 bases [ 8 ]) and grouped into clusters in intergenic regions, represent a library of potentially dangerous genetic information (for an overview of the microbial antiviral arsenal, see reviews by Isaev et al. [ 9 , 10 ]). Initially, it was assumed that such a system would work by the mechanism of RNA interference. However, in the publication of Marraffini and Sontheimer, it was experimentally demonstrated for the first time that the actual target of the immune system of prokaryotes was foreign DNA [ 11 ], and not mRNA, and, therefore, the use of such a system in the laboratory could represent a potential tool for genomic editing. Interestingly, later studies demonstrated that some of the described CRISPR systems do work with RNA molecules directly [ 12 , 13 ] and, therefore, can be used to deactivate specific transcripts inside the cell in a selective way [ 14 , 15 ].

The first experimental information about the mechanism of action of the CRISPR system was obtained in 2007 in the studies of two French food scientists, Rodolphe Barrangou and Philippe Horvath, who worked with yoghurt cultures of bacteria Streptococcus thermophilus for the Danish company Danisco [ 16 ]. Due to the company’s rich collection of bacterial strains collected since the 1980s, scientists have been able to trace the historical course of the bacterial acquisition of spacers at the CRISPR locus in response to viral attacks by bacteriophages. The addition of new spacers in this work caused acquired immunity to the corresponding new types of bacteriophages in S. thermophilus : observation which subsequently led to the authors obtaining one of the first patents in this area [ 17 ] and the start of bacterial cultures’ “vaccination” with the use of CRISPR-based technology by Danisco in 2005 [ 18 ].

Currently, CRISPR repeats have been found in most archaeal genomes and nearly half of the studied bacterial ones, but they have not been found in eukaryotic or viral DNA sequences. The existence of CRISPR repeats in mitochondria was suggested in one of the earliest publications on the subject (the same article described CRISPR in cyanobacteria for the first time) [ 19 ]. The authors used a set of previously published data on the sequencing of mitochondrial plasmids from Vicia faba L. beans [ 20 ], and their conclusions were further cited by Mojica et al. [ 21 ], but these observations were not confirmed in later studies [ 8 ].

At the time of initial discoveries, a variety of different acronyms was used for CRISPR by individual scientific groups, which presently complicates the search for early articles on the topic. The current name for CRISPR first appeared in Jansen et al. [ 22 ] in 2002 and was suggested by Mojica in correspondence between the two collaborating scientific groups. The same publication was the first one to describe the presence of genes associated with CRISPR repeats (named by the authors cas1-4 , CRISPR-associated genes). These genes were found in close proximity to the CRISPR loci of various prokaryotes, and two of them contained motifs characteristic of helicase and nuclease, which supported the authors’ hypothesis about the non-random association of the cas genes with the CRISPR locus, and their involvement in DNA metabolism. Also in 2002, the same neighborhood of genes was described by a team of scientists led by Eugene Koonin from the NCBI Institute (Bethesda, USA), but the association of these genes with CRISPR arrays was not discerned by them at the time [ 23 ]. From the moment of the first discovery of genes associated with the CRISPR system, to the present day, their truly extraordinary abundance and diversity have been found in prokaryotic cells, including representatives of the families of helicases, nucleases, polymerases, and others. Proteins associated with this system can be assigned to either the adaptive module (participating in the acquisition of immunity, main representatives – Cas1 and Cas2), or the effector module (directly involved in the destruction of mobile genetic elements through their recognition and cleavage), with some additional and regulatory proteins also found to be associated with the system [ 24 ]. At present, a way of classification is recognized in which all currently known CRISPR–Cas systems are divided into 2 classes and 6 types, which, in turn, are also divided into numerous subtypes: at the time of writing the review, Makarova et al. [ 25 ] described >30 subtypes ( Fig. 1 ). The main difference between the classes is that the effector module of Class 1 systems is represented by a complex of several proteins, while in Class 2 it is a single multidomain protein (Cas9, Cas12, or Cas13) [ 26 - 28 ].

Conventional classification of known CRISPR–Cas systems.

Of all the known Cas proteins, the most studied ones are the proteins belonging to the system of directional cutting of foreign DNA (and, as it was found out later, in some cases, RNA), the so-called “genetic scissors”, among which is the nuclease Cas9. This protein was first described in connection with its association with CRISPR repeats in an article by Bolotin et al. [ 6 ], where it was originally named Cas5 (other alternative names are Csn1 and Csx12). In addition, the authors identified the presence of the HNH motif (His-Asn-His), which is also found in other nucleases. Another important observation made by Bolotin et al. was the discovery of a specific pattern in the nucleotide sequences on one side of the described spacers of the CRISPR arrays, but the understanding of the role for this phenomenon was only revealed in later studies. Currently, short motifs adjacent to protospacers but absent in the original spacers of the CRISPR locus are called PAMs (protospacer adjacent motifs) [ 29 ]. Protospacers are DNA fragments that are attacked by the immune system of prokaryotes, and are identical to the corresponding spacers at the CRISPR locus, except for the PAM motif. These motifs are important at the stage of recognition of potentially dangerous genetic information; their presence at the end of the sequence signals that the DNA fragment is foreign and needs to be destroyed, while the DNA sequences stored in the CRISPR locus as spacers and not containing PAM motifs are not attacked by the prokaryotic immune system.

A crucial player in the CRISPR–Cas9 system turned out to be a short RNA molecule, a processed product of transcription from the CRISPR locus that directs proteins of the prokaryotic immune system to foreign molecules with genetic information. A group of researchers led by John van der Oost (Wageningen University, the Netherlands), who described the existence of such RNA molecules, gave them the name crRNA (CRISPR-associated RNA). It was also noted that the initial result of transcription from the CRISPR locus is a pre-crRNA precursor molecule consisting of several spacers and repeats, which is later cleaved into individual fragments [ 30 ]. In the work of the group led by Virginijus Siksnys (Vilnius University, Lithuania), it was demonstrated that the length of the actual “guide” crRNA sequence of 20 base pairs, complementary to the target DNA, is necessary and sufficient for the nuclease activity of the CRISPR–Cas complex, even if the spacer in CRISPR locus is represented by a longer sequence of nucleotides [ 31 ]. This publication was one of two in vitro studies, carried out in parallel and independently in competing laboratories, that described, for the first time, how the Cas9 enzyme uses crRNA to attack foreign DNA.

The final missing piece in the puzzle, without which it is impossible to assemble a working CRISPR–Cas9 system in vitro , turned out to be another short RNA molecule, discovered in connection with its participation in crRNA processing by Emmanuelle Charpentier’s group in 2011 [ 32 ]. This molecule, essential for nuclease activity, was named tracrRNA (trans-activating CRISPR RNA). In subsequent work, ultimately acknowledged by the Nobel Prize, the role of tracrRNA in the mechanism of target DNA cutting was shown. It was also proposed at the time that two RNA molecules, crRNA and tracrRNA, could be combined into one chimeric molecule (sgRNA – single guide RNA), which greatly facilitated the practical use of the CRISPR–Cas9 system in subsequent applications [ 33 ]. Figure 2 shows the timeline of the historical events in the discovery of the CRISPR–Cas9 system’s components: initially the CRISPR locus itself, then the proteins associated with it, including Cas9, and later, two RNA molecules necessary for the formation of the ribonucleoprotein complex and recognition of substrate DNA.

Historical timeline of discoveries of the components of the CRISPR–Cas9 system. 1987 – Short DNA repeats, later called CRISPR, were first noticed in bacterial genomes, and, in 1995, also found in archaea. 2005 – The role of CRISPR loci in the protection of prokaryotes from foreign genetic information was proposed, and the Cas9 protein was described for the first time (initial information on proteins associated with the CRISPR locus appeared in 2002). Two RNA molecules, crRNA and tracrRNA, were discovered as part of the complex in 2007 and 2011, respectively. The Nobel Prize-winning work, where all of the components were assembled in vitro and two RNA molecules combined into one strand for the ease of use of the system, was published in 2012.

USE OF THE CRISPR–Cas9 SYSTEM IN EUKARYOTIC CELLS

The discovery of the necessary and sufficient components of the CRISPR–Cas9 system started a race to be the first to apply the system to the genetic editing of human and animal cells. In January 2013, almost simultaneously, five research articles authored by different research teams appeared, all reporting that they had achieved the goal. Two publications from the same issue of the journal Science , offering probably the best approach to the problem had been produced by the laboratories of George Church (Harvard University, USA) and Feng Zhang (Broad Institute, USA). In these publications, it was shown that for successful DNA editing in human cells, it was necessary to carry out several steps: these include codon optimization and the addition of a nuclear localization signal to the cas9 gene, lengthening of the sgRNA molecule (to improve the efficiency of the system), as well as the possible addition of a DNA template for homologous recombination with which the cells can repair the DNA double break (the last step was described only by the group of G. Church) [ 34 , 35 ]. Also in January 2013, similar publications came out from the laboratories of Jennifer Doudna (Berkeley College, USA) [ 36 ], Jin-Soo Kim (Seoul University, South Korea) [ 37 ] and J. Keith Joung (Harvard School of Medicine, USA) [ 38 ]. In the last article [ 38 ], the described work was carried out on zebrafish rather than human cells but, importantly, the use of the CRISPR–Cas9 system on germline cells was demonstrated for the first time.

FIRST CRYSTALLOGRAPHIC STUDIES

The most studied protein from the Cas group is the Cas9 nuclease; in the ~20 years since the discovery of the cas genes more than 20,000 articles in the PubMed system mention the name Cas9 in one context or another. Attempts to obtain detailed information about the structure of this protein resulted in the first two crystallographic studies being published almost simultaneously: in February 2014 two crystal structures of Cas9 appeared in the database PDBe (“Protein Data Bank in Europe”), and the accompanying articles were published in the journals Nature and Cell [ 39 , 40 ]. The structure that came out of the laboratory of Jennifer Doudna was of an apo-protein (PDBe ID 4cmp, PDBe DOI: 10.2210/pdb4cmp/pdb), while the research group of Osamu Nureki (University of Tokyo, Japan) succeeded in crystallising the protein in a complex with a “guide”-RNA and “target”-DNA (PDBe ID 4oo8, PDBe DOI: 10.2210/pdb4oo8/pdb).

These, as well as many subsequent studies, used the Cas9 protein from S. pyogenes , SpCas9, which consists of 1368 amino acids and is a multidomain and multifunctional endonuclease. Crystal structures revealed that the Cas9 protein is spatially divided into 2 lobes: a target recognition lobe and a nuclease lobe, with the guide RNA and target DNA occupying the positively charged groove at their interface. The key structures of the nuclease lobe of SpCas9 are 2 domains: HNH and RuvC, each of them cleaves one of the target DNA strands. Figure 3 shows the general architecture of the SpCas9–sgRNA–DNA complex, where the complex secondary structure of the bound RNA molecule, and the unwound state of the double-stranded DNA molecule with the formation of a DNA–RNA heteroduplex can be seen (PDB ID 5F9R, PDB DOI: 10.2210/pdb5F9R/pdb, [ 41 ]). At the time of writing, hundreds of crystal structures of the Cas9 family proteins are available from the PDB, PDBe, and PDBj databases.

Three-dimensional organization of the Cas9 protein in the complex with “guide” RNA (sgRNA) and substrate (Target DNA), crystallographic data (PDB ID 5F9R, PDB DOI: 10.2210/pdb5F9R/pdb).

PATENT DISPUTE

The understandable motive of individual scientists, as well as organizations involved in the study of the CRISPR–Cas9 system, was the possible financial gain potentially obtainable from the use of this promising technology. One of the first patent applications was filed jointly by the University of California at Berkeley, representing Doudna, the University of Vienna (where one of the two lead authors from the key publication on CRISPR–Cas9 worked [ 33 ]), and Charpentier as an individual inventor in accordance with the rules of the University of Umeå (Sweden), where Charpentier worked at the time of publication of the article [ 18 ]. This patent application was filed in May 2012 [ 42 ], while in December 2012 Zhang and the Broad Institute also submitted a patent application [ 43 ] simultaneously with the acceptance of Zhang’s paper on human cells’ editing for publication in Science [ 35 ]. Initially, it was Zhang’s application that turned out to be successful and resulted in a patent in April 2014, while Doudna’s application was still pending at that time. Doudna’s team disagreed with the decision, after which a long dispute between the two parties followed, including appeals and court hearings which ultimately led to an ambiguous situation in CRISPR–Cas9 licensing. Due to the fact that by 2019 both competing parties had patents in this area, some of the biotech companies that used the CRISPR–Cas9 system on human cells received a license from the team of Doudna, while others – from Zhang. However, the U. S. Patent and Trademark Office Appeal Board in February 2022 again confirmed the priority of Zhang and the Broad Institute in the position of the patent holder for the use of CRISPR–Cas9 in human cells, which caused disappointment and frustration from the opposing side, and financial complications for companies licensed by the team of Doudna [ 44 ]. Doudna and Charpentier, however, won a similar dispute in Europe, and also hold major patents on the use of technology in the U.K., China, Japan, Australia, New Zealand, and Mexico [ 18 ].

GENE THERAPY AND ETHICAL ISSUES ASSOCIATED WITH IT

The haste with which competing laboratories sought to bring their research to the public’s attention, as well as the race to patent this technology, were indicators of the significance of this scientific breakthrough. Undoubtedly, one of the main driving forces that motivated many scientists to take part in research using this particular technology was the potential of modifying human cells, both somatic and germline. However, despite the apparent advantages of the CRISPR–Cas9 system, numerous ethical and technical difficulties stand in the way of researchers who dream of curing life-threatening diseases, especially if the genetic changes resulting from such manipulations can be inherited.

Gene therapy was administered for the first time in September 1990: a four-year-old girl suffering from adenosine deaminase (ADA) deficiency received an infusion of genetically engineered T-lymphocytes. Cells taken from the girl’s blood were modified using a viral vector – a deactivated virus that carries a healthy copy of the gene. As journalists who covered the story noted “rarely in modern medicine has an experiment been filled with so much hope”, and the doctor who performed this procedure, W. French Anderson, became known as the “father of gene therapy”. As time went on, however, the disturbing evidence of the adverse side effects of some attempts at gene therapy in both animals and humans began to accumulate. The tragic story of Jesse Gelsinger, an American teenager from Philadelphia who died from the effects of gene therapy in 1999, shocked the world and caused widespread skepticism and a significant delay in the development of the technology. In the case of Gelsinger, a large-scale autoimmune response of the body to a viral vector carrying the ornithine transcarbamylase gene led to a sharp increase in body temperature, renal and pulmonary failure, jaundice, impaired blood clotting, and subsequent death within only four days from the moment of gene therapy administration [ 45 ].

Extensive discussions of the safety and, importantly, the ethical issues arising from the possibility of potential gene therapy with CRISPR–Cas9 began soon after the first publications showing this system’s use in human cells. One of the first steps in initiating formal discussions was taken by Doudna, who organized a conference on scientific, medical, legal, and ethical issues related to the genomic modification, held in the Napa Valley in California in January 2015. A subsequent report of the results of the conference was published in March 2015 in the journal Science [ 46 ], which essentially carried recommendations to strongly discourage work on introducing heritable changes in human embryonic cells, at least for the duration of active discussions of the social, environmental and ethical consequences of such manipulations. Almost simultaneously with this report, a comment was also published in the journal Nature about the serious risks linked to creating heritable changes in human embryos [ 47 ]. The authors expressed concerns that premature work on embryonic cells could have a negative impact on the field of gene therapy in general, and could set back the work of researchers attempting to treat genetic and infectious diseases in somatic cells for years. The March 2015 report from the Napa conference and the commentary in Nature urging not to edit the human embryonic genome were released amidst growing agitation in the scientific community over leaked news that such experiments had actually already been carried out. A group of scientists from Sun Yat-sen University (Guangzhou, China), after unsuccessful attempts to get their manuscript accepted by the journals Nature and Science , in April 2015 finally published their article on the use of the CRISPR–Cas9 system on human embryonic cells [ 48 ]. The researchers emphasized that they used non-viable embryos obtained by the fusion of two sperm cells with one egg and, therefore, discarded by in vitro fertilization (IVF) laboratories. The main conclusion of the article was that the CRISPR–Cas9 technology at the time of the study was not yet ready for use on human embryonic cells due to the identified shortcomings in the system’s efficiency and specificity. A comment of the journal Protein & Cell (Beijing, China), that published this work, stated that the article (in addition to its scientific value) would promote an open exchange of information about current research in the area; and despite the ambiguity of the issue and conflicting opinions on the topic, the publication would stimulate the necessary discussions about genomic editing of germline cells. Interestingly, the manuscript had been sent to Protein & Cell together with the references obtained during previous attempts to publish the work, and was accepted by the editors for publication within two days from the date of submission. The subsequent debate in the scientific community was described as “epic” [ 49 ] and provoked interest in this complex issue from the wider public, as well as in governmental and regulatory organizations in various countries.

The notorious scandals caused by the conduct of medical experiments on humans in the past have led to the creation of general international guidelines on bioethics. The best-known documents in this area are the Nuremberg Code, developed after the trial of Nazi doctors in 1947, and the subsequent Declaration of Helsinki from 1964, which expanded the principles of the code and detailed the application of these principles to clinical research. Another important document, the Belmont Report, was issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the United States in 1978. This commission was created in the wake of shocking revelations of an inhumane syphilis study from 1932 to 1972 in Tuskegee. For decades, hundreds of impoverished African-American men infected with syphilis have been studied for the progression of their disease. Although penicillin had become the standard treatment for syphilis by 1947, it was not offered to study participants, despite the obvious physical suffering of the patients and the continued spread of the infection in their families.

The Nuremberg Code, the Declaration of Helsinki and the Belmont Report are based on the basic ethical principles of biomedical research, such as respect for the individual, informed consent of the patient, understanding of the risks and benefits, voluntary participation, fairness in the conduct of experiments, maximum professionalism of the researchers, etc. These principles, and their application in medical practice, are relevant to the events of November 2018, when the Chinese scientist Jiankui He announced the birth of babies who, for the first time, had undergone gene modification using the CRISPR–Cas9 system. The injection of this system into the mother’s egg was made at the stage of the IVF procedure immediately after the fusion of the sperm, and therefore all the changes potentially introduced into the genome during this procedure would be heritable. The world scientific community was shocked at how premature such medical experiments were, and the high degree of risk taken by the researchers conducting the experiment. In particular, scientists were worried about the possibility of creating unplanned (“off-target”) mutations in the genome of future babies. At the time of the experiment He (also known under the shortened name JK – from Jiankui) was not a well-known figure in the CRISPR–Cas9 community, however, after the announcement of his experiments, he attracted world-wide attention. He studied physics at the University of Science and Technology (Hefei, China) and then moved to the United States, where he received his PhD under the supervision of Michael Deem, Professor of Physics, Astronomy and Bioengineering at Rice University (Houston, Texas), and later worked as a post-doc at Stanford University (California) in the laboratory of Professor Stephen Quake. In the group of Deem He used the methods of theoretical biophysics, mathematical modelling and computer simulations, publishing papers on, among other things, influenza virus strains and spacer sequences in CRISPR loci [ 50 , 51 ], while in the laboratory of Quake, he learned the methods of molecular biology and became interested in the innovative technologies of Silicon Valley. Returning to China, He continued his collaboration with Deem, and also successfully implemented the innovative ideas in the field of DNA sequencing of his second supervisor, Quake, creating a successful company Direct Genomics based on the technology [ 18 , 52 ]. In China, he became quite famous as a young scientist and successful entrepreneur who had returned from abroad under the Thousand Talents program. He received a position and a laboratory at the Southern University of Science and Technology (SUStech, Shenzhen), and participated in the creation of several start-up companies [ 53 ]. The next step in his career resulted in the biggest medical scandal of the last decade. In 2017 on WeChat social media platform, He announced that he was recruiting volunteers from among married couples who wanted to produce children genetically modified to be resistant to the human immunodeficiency virus (HIV). Among the conditions of recruitment was that in the couple who wished to participate in the experiment both people had a university degree, so that they had enough educational background to understand the basics of science and medicine. A second condition was for the man to be HIV-positive and for the woman – HIV-negative: a situation in which the risk of transmitting the virus to the baby would be minimal (provided that the sperm was “washed” during the IVF procedure), but made it likely that the couple’s motivation to participate in the experiment would be high [ 53 ]. He planned to modify the CCR5 gene, a known receptor on the cell surface, through binding to which the human immunodeficiency virus enters the cell. About 300 people responded to the advertisement, of these, 20 couples were selected for the next round of consultations, during which the participants learned about the procedure and the possible risks. From these consultations 11 couples agreed to participate in the studies, of which seven were ultimately selected by the researchers for the next stage – the IVF procedure with an additional step of genome editing. The motivation of individual participants was, apparently, not only the possibility of having children (the IVF procedure in China is prohibited if one of the parents has HIV infection), but also the desire to take part in an “historic” experiment designed to benefit future generations [ 53 ]. Ultimately, after several unsuccessful attempts, from a selected group of participants 2 pregnancies led to the birth of babies who had undergone a genomic modification procedure using the CRISPR–Cas9 system. Quite a lot is known about the first pregnancy, which resulted in the birth of two twin girls, Lulu and Nana (pseudonyms used in the press and scientific literature in order to protect their identity). Very little information is available on the second pregnancy, which resulted in the birth of another child. Since this event occured after the scandal caused by the birth of the first twins, many details of the second pregnancy remained a secret. A manuscript written by He, based on the results of the first pregnancy and named “Birth of twins after genome editing for HIV resistance” remains unpublished, but has been leaked to the scientific community [ 54 , 55 ]. It has become known, for example, that in one of the embryos both copies of CCR5 were inactivated (Nana), while in the second, only one was modified (Lulu) [ 56 ]. Therefore, only Nana has a chance to be protected from HIV infection in the future, at least from the main variants of the virus that enter the cell through binding to the CCR5 receptor. In the case of Lulu, unfortunately, the treatment will provide no protection, since one copy of the CCR5 gene is enough to produce the corresponding receptor on the membrane. It is believed that two embryos were implanted in the uterus of a future mother in the hope that at least one of them will lead to the birth of a genetically modification baby. The twins were born premature (at 31 weeks) and spent the first weeks of their lives in neonatal incubators but were otherwise described as “healthy” [ 53 ]. Scientists who had gained access to the unpublished manuscript of He, also noted that several cells selected for sequencing early in embryonic development were in fact mosaics, an observation that led to increased criticism of He’s work. In the case of mosaicism, any information obtained during the sequencing of selected cells cannot be extrapolated to the entire embryo as a whole. Therefore, at the time of the key decision of whether to transfer the embryos into the womb, the researchers could not be sure that the CRISPR–Cas9 system did not produce any dramatic off-target mutations in the remaining cells of the embryos, even if the sequencing results showed the absence of such modifications in the selected cells. Many other aspects of the conduct of the study also received harsh criticism from the scientific and medical community [ 54 ], including the questionable circumstances of obtaining permission from the ethics committee of a hospital in Shenzhen, the level of qualification of He for clinical research (lack of medical education and adequate experience in the field), the choice of the gene that has undergone editing (social rather than medical reasons for patients seeking help), possible side effects from the lack of a valid copy of CCR5 , etc. According to an American cardiologist and Professor of Medicine at the University of Pennsylvania Kiran Musunuru, the first babies of “the CRISPR generation”, unfortunately, were born not as a result “of a historic scientific achievement, but rather a historic ethical fiasco” [ 56 ]. A preceding PR-campaign conducted by He and his team resulted in fairly flattering initial news coverage of his work in the People’s Daily (the largest newspaper group in China). However, the following international scandal led to the placement of He under house arrest, and then to a 3-year prison sentence. He has already been released from prison, but little is known about his whereabouts and future plans [ 57 ].

A few months after the described scandal the Russian scientist Denis Rebrikov stirred up the international scientific community with a statement about his intention to become the second scientist in the world to create genetically modified babies. Rebrikov, a Professor at the Pirogov Russian National Research Medical University and Head of the Laboratory of Genomic Editing at the Center for Obstetrics, Gynecology and Perinatology, announced that his research facility was potentially ready to transfer modified embryos into the mother’s womb in June 2019 [ 58 ]. As in the experiments of He, he was planning to edit the CCR5 gene, and the preliminary work from his laboratory on non-viable embryos was published in the Bulletin of the Russian National Research Medical University [ 59 ]. The reaction of the scientific community to the statement was heated and primarily negative. In October 2019 the journals Nature and Science published news feeds reporting that at that time, Rebrikov had already switched to editing the GJB2 gene associated with inherited deafness, and was in the process of selecting couples who would agree to take part in the experiment [ 60 , 61 ]. However, in numerous interviews with journalists Rebrikov emphasized that he would only conduct such experiments after obtaining all necessary permits from both regulatory and ethical authorities. This significantly distinguished his approach from He’s, who informed the scientific community about the birth of babies with a modified genome post factum . The Ministry of Health of the Russian Federation (following the recommendation of the World Health Organisation) later made a statement that the decision to grant permission for such a study would be premature and irresponsible, which prevented the further development of the situation at least until the situation in the regulatory sphere changes [ 62 ].

At the time of writing this review, the state of the legal framework that regulates the issue of genomic editing of human embryonic cells varies greatly in different countries. Thus, genomic modification of embryos for purposes other than reproductive is allowed in at least 11 countries, including China, the U.S., and the U.K. Nineteen countries, including Belarus, Canada, Sweden, and Switzerland, prohibit such experiments. Many other countries (Russia among them) take an intermediate or indeterminate position. The situation with the introduction of inherited genomic changes into embryos subsequently used for reproductive purposes is even more complicated [ 63 ].

MEDICAL APPLICATIONS WITH HUMAN SOMATIC CELLS

Despite increased attention to the introduction of heritable changes in germline cells, the less controversial and currently more common use of CRISPR–Cas9 for medical purposes is the modification of human somatic cells. As described above, in the first attempts at gene therapy (1990) an adeno-associated viral vector was used that delivered a healthy copy of the gene into cells (in the U.S. this technology was finally approved for clinical use only in 2017 [ 64 ]). The next step in the development of gene therapy was the introduction of genomic editing with the use of Homing Endonucleases (HEs), Zinc Fingers Nucleases (ZFNs), Transcription Activator-Like Effector Nucleases (TALENs), and later also CRISPR–Cas9 [ 65 ]. The first human clinical studies using CRISPR–Cas9 commenced in October 2016 in China [ 66 ]. The PD-1 gene was inactivated ex vivo in blood cells in the hope that such modified cells, would attack the non-small-cell lung cancer that the patient suffered from when returned to circulation. In the U.S., ex vivo therapy using CRISPR–Cas9 was first performed in July 2019 on a patient with sickle cell anemia (CRISPR Therapeutics, founded by Charpentier). The therapy significantly improved the patient’s condition for at least a few months after the procedure, however the cost of such treatment at the time of its implementation in the United States was estimated to be in the region of 0.5-1.5 million U.S. dollars. The high current cost of CRISPR–Cas9 therapy will probably act as an obstacle to its widescale use, even if clinical trials confirm the efficacy and safety of such treatment [ 18 ]. Currently, the most expensive drug on the market is Zolgensma, another gene therapy treatment used for spinal muscular atrophy ($2.125 million per dose). Zolgensma directly delivers a working copy of the defective gene into cells with the use of adeno-associated virus, a method different from genomic editing using nucleases [ 67 ].

The first example of an in vivo clinical study in which cells undergo in situ genomic editing with nucleases was performed using the ZFNs technology. Sangamo Therapeutics first performed this procedure in July 2017 on a patient suffering from Hunter syndrome (a rare genetic disease, form of mucopolysaccharidosis). The pioneers in using CRISPR–Cas9 for in vivo genomic editing were Editas Medicine (March 2020) [ 68 ]. A drug called EDIT-101 was injected locally into the retina of a patient suffering from a form of inherited blindness caused by a mutation in the CEP290 gene. Currently, various clinical studies are underway on the use of CRISPR–Cas9 for the treatment of diseases such as Alzheimer’s disease, various types of cancers, high cholesterol, angioedema, acute myeloid leukemia, and even androgenetic alopecia (baldness). Another promising application for CRISPR–Cas9 in the future could be the treatment of infectious diseases caused by such pathogens as, for example, HIV and human papillomavirus [ 65 ].

CONCLUSIONS

The discovery of CRISPR–Cas9 as an immune system in prokaryotes at the turn of the 20th-21st centuries – a finding at first glance only relevant to microbiology – has led to a revolution in the field of genomic manipulations. New opportunities have opened up in multiple areas of biomedicine, such as molecular diagnostics of infectious and non-infectious diseases (e.g., genotyping of bacterial strains, detection of viruses, and identification of genetic mutations in circulating extracellular DNA in patients with lung cancer [ 69 ]), as well as in the development of a potentially new method of immunization, DNA vaccines [ 18 ]. One of the more unusual examples of the application of the CRISPR–Cas9 system was the cultivation of brain-like organelles carrying different variants of the important NOVA1 gene characteristic of modern humans, Neanderthals, and Denisovans [ 70 ]. The development of CRISPR–Cas9 technology is a good example of how discoveries made in the course of basic research can change entire fields of science and technology, expanding the horizons of the possible. This ground-breaking technique is a worthy continuation of such exciting scientific events as the publication of the double-stranded structure of DNA by Watson and Crick in 1953, the birth of the first child by in vitro fertilization in 1978, and the cloning of Dolly the sheep in 1996. In the coming years the scientific community will watch with interest the development of legislation and ethical principles in the application of the CRISPR–Cas9 system in genome editing, as well as in what other areas of science this promising technology will find its application.

Acknowledgments

The author recalls with warmth and gratitude the years spent in the laboratory of Andrei Dmitrievich Vinogradov at the Department of Biochemistry of Moscow State University. The experiments conceived by Andrei Dmitrievich invariably brought interesting results, while his vast knowledge in various fields of science enabled staff and students to feel confident that any questions would be answered, and the time spent in the laboratory would bring well-deserved results. The publication of the results of the work carried out under the supervision of Andrei Dmitrievich gave the author the necessary start in scientific life and the opportunity to continue research in other laboratories and other fields of knowledge. A unique team of scientists, selected by Andrei Dmitrievich: Vera Georgievna Grivennikova, Tatiana Vadimovna Zharova, and Eleonora Vladimirovna Gavrikova, provided a family atmosphere of trust and support in the laboratory, for which the author is very grateful.

Abbreviations

Ethics declarations

The author declares no conflicts of interest. This article does not contain a description of the studies performed by the author with the participation of people or animals as objects.

Amy Dudley, MD

Dr. Dudley received her medical degree from the University of Texas Medical School at Houston in 2016. She completed a Family Medicine internship and residency at Texas A & M University in 2017 and 2019, respectively. She was certified by the American Board of Family Medicine in 2019 and joined Moscow Family Medicine in October 2020. Request an Appointment

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Dr. Dudley received research awards in both medical school and her residency.  While in residency, she was Chief Resident and also received a teaching award.  Dr. Dudley worked with many Moscow area physicians throughout her medical training and after visiting Moscow she and her husband found the people to be both warm and welcoming!  It was an easy decision to move here upon completion of her schooling.

Her mother, a pediatrician, had an enormous impact on Dr. Dudley’s decision to join the medical field.  Her mother’s ability to care for the community as well as her family is something that Dr. Dudley strives to practice every day.  Dr. Dudley feels the most proud when she is able to have been a part of a patient making positive changes in their life where they are able to see the results and reap the benefits- whether that be quitting smoking, finding a plan to address depression, or controlling their diabetes.

Dr. Dudley has a wonderful husband, daughter, and a sweet dog.  Outside of work she and the family enjoy skiing, tennis, hiking, scuba diving, reading, and live music.

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Moscow Times Examines How Drug Shortages in Russia Are Leading Doctors to Prescribe Replacement HIV/AIDS Meds to Patients

In Russia, some patients living with HIV/AIDS, whose regular drug therapy was replaced by "another, less preferable drug," are bringing lawsuits against state-run treatment centers in the hopes of returning to their preferred drug regimen, the Moscow Times reports. "Supplies were delayed nationwide this year because the Health and Social Development Ministry, which buys medicine for HIV patients once a year, was two months too late initiating a tender for suppliers, Vadim Pokrovsky, head of the Federal AIDS Center, said in a telephone interview," according to the newspaper. The article examines the reports of HIV drug shortages at clinics throughout country, and describes the side effects from medications patients can experience when switching HIV/AIDS medications. The piece profiles a woman living with HIV/AIDS who brought a law suit against an treatment center and was placed back on her original HIV/AIDS medications, and describes how patients' concerns over social stigma may lead them to avoid this approach (Krainova, 11/16).

This information was reprinted from kff.org with permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report , search the archives, and sign up for email delivery. © Henry J. Kaiser Family Foundation. All rights reserved.

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Family Medicine, an official journal of the Society of Teachers of Family Medicine, aims to publish high-quality, original scholarship about education in family medicine and primary care. The journal publishes original research, systematic reviews, narrative essays, and policy analyses relevant to the discipline of family medicine, particularly focusing on primary care medical education, health workforce policy, and health services research. The journal does not publish clinical review articles.

Family Medicine   is relied on by more than 5,000 family physicians, psychologists, sociologists, and public health specialists for the latest research and commentary on medical education.

Family Medicine   is indexed in Medline, PubMed, MEDLINE, EBSCO, EMBASE, Health and Psychosocial Instruments, Current Contents ® /Clinical Medicine, Science Citation Index, and select articles from the Educational Resources Information Center Clearinghouse on Higher Education.

ISSN (Online): 1938-3800 ISSN (Print): 0742-3225

2022 JCR Impact Factor: 2.24

Editorial Team

Editorial board, diversity statement.

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Sarina Schrager, MD, MS

Editor in chief.

Sarina Schrager, MD, MS, is a professor in the University of Wisconsin’s Department of Family Medicine and Community Health (UW DFMCH). She also serves as UW DFMCH’s director of promotions and mentoring and as Wisconsin Research and Education Network’s medical director. Prior to becoming the editor in chief of Family Medicine , she served in the same capacity at Wisconsin Medical Journal , as an editor for FPM, and on the editorial board of the Journal of the American Board of Family Medicine . Her research expertise is in residency education and faculty development, and her recent work has focused on shared decision-making in cancer screening. She obtained her MD at the University of Illinois, Chicago, her residency training as well as a primary care women’s health fellowship at MacNeal Hospital, and a faculty development fellowship at UW DFMCH.

José E. Rodríguez, MD

Deputy editor.

José E. Rodríguez, MD, is the associate vice president of the University of Utah Office of Health Equity, Diversity, and Inclusion. He is also a professor in the University of Utah Department of Family and Preventive Medicine, and an associate medical director at the Redwood Health Center. Dr Rodriguez currently serves as president of the Family Physicians Inquiries Network (FPIN), and is an associate editor for the Annals of Family Medicine . His research focusses on evidence-based medicine, faculty development, underrepresented in medicine issues, and health equity. He received his MD from Weill Cornell Medicine and completed his residency at Albert Einstein College of Medicine, Montefiore Hospital.

Octavia Amaechi, MD

Deia editor.

Octavia Amaechi, MD, serves as the chief of staff, a hospitalist, and Health Equity Committee chair at the Spartanburg Regional Healthcare System and as a faculty physician in the Spartanburg Regional Family Medicine Residency (SRFMR) program. She holds positions as a mentor in STFM’s Leadership Through Scholarship Program, a board member of the Spartanburg County Medical Society, an annual delegate and reference committee chair of the South Carolina Medical Association, and member of the South Carolina Academy of Family Physicians Committee on Diversity, Equity, and Inclusiveness. Her expertise is in diversity, equity, inclusion, antiracism, patient and community advocacy, inpatient/hospital medicine, and MAT for Opioid Use Disorder. She completed her MD at the University of Health Sciences Antigua, her residency training at SRFMR, and a hospital medicine fellowship at Spartanburg Regional Healthcare System.

William Cayley, Jr, MD, MDiv

Editor, book and media reviews.

William Cayley, Jr, MD, is an adjunct clinical professor at the Medical College of Wisconsin and the University of Wisconsin School of Medicine and Public Health as well as a faculty member at Prevea Family Medicine Residency at Augusta and Eau Claire. His expertise is in evidence-based medicine, cardiovascular disease, diabetes, and writing. He serves on the Cochrane Heart Group editorial team and the DynaMed editorial board. He completed his MD at the Medical College of Wisconsin and his family medicine residency training at the Prevea Family Medicine Residency at Eau Claire.

LaKesha Anderson, PhD

Associate editor.

LaKesha N. Anderson, PhD, is assistant professor of medicine and health professions education in the Center for Health Professions Education at the Uniformed Services University of the Health Sciences. She also serves as a lecturer in Johns Hopkins University’s Communication MA Program. A communication scientist, her work explores the intersections of communication, medicine, and education. Her research has examined topics including social support, miscommunication, credibility, trust, and information-seeking and her primary areas of interest include maternal and women’s health, medical education, and professional development. Dr Anderson earned a PhD in Health and Strategic Communication from George Mason University. She is also a certified doula, working to provide birthing people with holistic care that includes physical, emotional, and educational support both pre- and post-birth.

Yohualli Anaya, MD

Yohualli Anaya, MD, is an associate visiting professor in the University of Wisconsin School of Medicine and Public Health in Madison’s Department of Family Medicine and Community Health. She also serves as faculty expert at the UCLA Latino Policy & Politics Institute (UCLA LPPI) and codirector of the UCLA Center for the Study of Latino Health and Culture Accelerating Latinx Leadership Institute. Her expertise is in educating preclinical and clinical learners in providing care to minoritized populations. Her research has been funded by UCLA LPPI and the California Health Care Foundation. Currently her work focuses on barriers to health and equity in health care delivery, physician workforce diversity, and the application of research to promote health equity policies. She completed her MD at the University of Southern California Keck School of Medicine and her residency training at the UCLA Family Medicine Residency Program.

D. Jason Frasca, DO

Jason Frasca, DO, is an assistant clinical professor at Virginia Commonwealth University, where he also serves as the associate program director of the family medicine residency program. His expertise is in behavioral health, physician wellness, meditation- and mindfulness-based intervention, mindset/bias, teaching patient rapport and professionalism, and medical narratives. He completed his DO at the West Virginia School of Osteopathic Medicine, his residency training at Dwight D. Eisenhower Army Medical Center, and his medical editing fellowship at Society of Teachers of Family Medicine.

Valerie Gilchrist, MD

Valerie Gilchrist, MD, received her MD from the University of Toronto. She attended a faculty development fellowship at the University of North Carolina-Chapel Hill, and the Hedwig Van Ameringen Executive Leadership in Academic Medicine Program. She is board certified in family medicine and has served as chair of family medicine at the Northeastern Ohio Universities College of Medicine, East Carolina University Brody School of Medicine, and University of Wisconsin School of Medicine and Public Health. She is co-editor of four books, one monograph, numerous book chapters, peer-reviewed publications, and grant awards. She served as a National Board of Medical Examiners reviewer, on an AHRQ study section, and a member of several editorial boards. She is a past president of the Association of Departments of Family Medicine and served on the boards of the North American Primary Care Research Group, the Society of Teachers in Family Medicine, and the Council of Academic Societies of the American Association of Medical Colleges. 

Lisa Harris, DO

Lisa Harris, DO, is an associate professor of family medicine and the assistant dean for Pathways and Recruitment at the Uniformed Services University of the Health Sciences (USU).    She is faculty physician at the National Capital Consortium Family Medicine Residency at AT Augusta Military Medical Center in Fort Belvoir, VA and recently served as USU Addressing Racism and Bias Task Force Chair .   Dr Harris is also a member of STFM’s inaugural Academic Family Medicine Antiracism Learning Collaborative and Medical Student Education Committee. Her expertise is in health equity, bedside teaching, curriculum development, learners in difficulty, and individual learning plans.  She earned her DO at the Philadelphia College of Osteopathic Medicine, completed family medicine residency at Womack Army Medical Center, Fort Liberty, NC, and completed the  University of North Carolina-Chapel Hill Faculty Development fellowship.

Jennifer Lochner, MD

Jennifer Lochner, MD, is an associate professor in the University of Wisconsin–Madison (UW–Madison) Department of Family Medicine and Community Health. She is the clinical service chief for UW–Madison’s family medicine residency teaching clinics as well as a knowledge assessment consultant for the American Board of Family Medicine. Her expertise is in physician compensation, physician electronic health record workload, clinician burnout, and clinical operations. She obtained her MD at the UW–Madison and completed her residency training at Oregon Health & Science University.

Daniel Parente, MD, PhD

Daniel Parente, MD, PhD, serves as an assistant professor in the Department of Family Medicine and Community Health at the University of Kansas Medical Center (KUMC). He also holds the position of research director for the KUMC Family Medicine Residency Program. Dr Parente is a Fellow of the American Academy of Family Physicians and is board-certified by the American Board of Family Medicine (ABFM). He is also recognized by ABFM with a Designation of Focused Practice in Hospital Medicine. Dr Parente has an avid interest in engaging resident physicians and medical students in the primary care research process and is passionate about teaching them about critical assessment of scientific literature. His research explores the use of advanced technologies—such as artificial intelligence (AI) and machine learning (ML)—in conjunction with multivariable methods, to enhance the quality of primary care and further medical education. 

Meaghan Ruddy, PhD

Meaghan Ruddy, PhD, is the chief research and development officer and senior vice president of academic affairs, enterprise assessment, and advancement at The Wright Centers for Graduate Medical Education and Community Health. She is also an adjunct clinical faculty member at the A.T. Still University School of Osteopathic Medicine in Arizona and holds board positions on the National Association of Community Health Centers Committee on Health Center Excellence and Training, Health Resources and Services Administration (HRSA) Rural Health Peer Advisory Team, HRSA Community-based Training Peer Team, among others. Her expertise is in clinical ethics and bioethics, transformative learning theory, qualitative research, human development, and health center programming. Her current work focuses on teaching health center community benefit and developing trauma-informed organizations. She obtained her PhD at Marywood University.

Sara Shields, MD

Sara Shields, MD, is a professor of family medicine and community health at the University of Massachusetts (UMass) Chan Medical School, the director of inpatient perinatal services at UMass Memorial Hospital, and a family physician at the Family Health Center of Worcester. Her expertise is in maternal and child health and women’s health, with special focus on normal labor, breastfeeding, and group prenatal care, as well as the humanities, including visual arts and reflective writing. She is the chair of the Worcester Healthy Baby Collaborative, a coalition of local community groups and health providers working to reduce infant mortality receiving grants from the March of Dimes, local agencies, and the National Network of Libraries in Medicine. She completed her MD at the University of California–San Francisco, her family medicine residency at the Highland Hospital–University of Rochester Medical Center, and a fellowship in maternal and child health at Brown University.

Sommer Aldulaimi, MD ,  University of Arizona Kendall Campbell, MD, University of Texas Medical Branch, Galveston Annie Derthick, PhD ,   Central Maine Medical Center FMR, Lewiston, ME Edgar Figueroa, MD, MPH , Weill Cornell Medical College of Cornell University Krys Foster, MD, MPH, Thomas Jefferson University Josh Freeman, MD, University of Arizona, Tucson, AZ Joseph Gravel, Jr, MD ,   Medical College of Wisconsin Joel Heidelbaugh, MD, University of Michigan Joyce Hollander-Rodriguez, MD, Oregon Health & Science University Mark Huntington, MD, PhD , Center for Family Medicine FMR, Sioux Falls, SD Christy J.W. Ledford, PhD, Medical College of Georgia at Augusta University, Augusta, GA Fareedat Oluyadi, MD ,   University of North Carolina Jeanette South-Paul, MD ,   University of Pittsburgh Priyanka Tulshian, MD, MPH, Contra Costa FMR, Martinez, CA Stephen Wilson, MD , MPH,   Boston Medical Center, Boston, MA Richard Young, MD ,   John Peter Smith FMR, Fort Worth, TX

Previous Editors-in-Chief

Lynn Carmichael, MD John Frey, MD Barry Weiss, MD John Saultz, MD

Peer Review Process

Submissions are initially reviewed for compliance to manuscript preparation guidelines. Compliant manuscripts are then assessed by the editor in chief, who makes an initial editorial decision. Some manuscripts are immediately rejected or given feedback directly from the editor. Most submissions are assigned by the editor in chief to one of the associate editors, who then assigns and coordinates peer review. A minimum of two peer reviewers are assigned to each compliant submission, and author revisions are typically needed as a result of reviewer comments.   Family Medicine   uses a single-blind peer review process for all submissions (authors do not know the identity of reviewers, but reviewers do know the identity of authors). When reviewer feedback has been addressed to the satisfaction of the associate editor, the associate editor makes a recommendation to the editor in chief, who makes the final determination regarding publication. Some final revisions may be requested at the time of acceptance by the editor in chief.

Use of Artificial Intelligence

Family Medicine encourages authors to appropriately use technology throughout the research process. Software that uses generative artificial intelligence (AI) or machine learning (ML) may be used. Family Medicine, however, only allows humans to be listed as authors of original articles. Software programs (eg, ChatGPT) cannot be listed as authors. Human authors must take public responsibility for the scientific integrity and originality of their work. Authors are also responsible for ensuring that their articles are free from plagiarism and bias.

Disclosure of the use of artificial intelligence and machine learning software is required by Family Medicine in certain circumstances:

• When generative artificial intelligence is used to aid in drafting parts of a manuscript (eg, to generate text, to create tables, to create figures, etc), this must be disclosed in the Acknowledgments section of the manuscript (eg, “The authors used ChatGPT to create Table 1.”)
• When generative artificial intelligence (eg, ChatGPT) is used as part of the analytical methods for an article , authors should clearly state this within the Methods section and explain steps taken to ensure the validity of those analyses. For example, if ChatGPT was used to transform unstructured data into a more structured format, the authors should describe this process (prompts, preprocessing, postprocessing, validation, etc) as they would any other analytical or statistical procedure.
• When artificial intelligence is used incidentally in other aspects of the research process, authors do not need to disclose this fact, unless such use is relevant to the meaning or interpretation of an article. For example, informal use of AI to aid in conducting a literature search for a simple survey project would not require disclosure, but formal use of AI tools to determine which articles to include in a systemic review would require disclosure.

Human Subject Recruitment and Informed Consent

Family Medicine   submissions for any study involving human subjects must describe the following:

• Institutional Review Board (IRB) interactions
• Consent processes
• Participation incentives
• Recruitment procedures, description of outreach, etc.

Study subjects’ identifying information should never be included in manuscript text or accompanying materials (eg, figures, tables, appendices) unless it is essential for the purpose of the study and the subjects have given written informed consent for publication. In any case where subjects’ identifying information is included in a submission, the corresponding author may be asked to provide documentation of informed consent.

Ethical Responsibilities of Editors and Reviewers 

Family Medicine   editors and reviewers must not disclose or discuss unpublished materials in a submitted manuscript with anyone other than the corresponding author, reviewers, or members of the   Family Medicine   editorial team.   Family Medicine reviewers are expected to declare their conflicts of interest and recuse themselves from the peer review process if a conflict exists for a manuscript they have been invited to review. Reviewers and associate editors are expected and encouraged to notify the editor in chief of suspected plagiarism, duplicate publication, and ethical concerns such as conflicts of interest among authors. Details regarding reviewer expectations and duties are outlined on this page:   https://journals.stfm.org/familymedicine/reviewers/

Corrections, Retractions, and Expressions of Concern

If a substantive error is identified in a published article, the editor in chief and associate editors will decide whether to publish a formal correction, retraction, or expression of concern statement,   or initiate a published discussion via letters to the editor . Substantive errors are confirmed errors that significantly affect the integrity of the publication or the interpretation of its results (eg, falsified, fabricated, or omitted data; plagiarism; undisclosed conflicts of interest). In such rare cases, a new document will be published in   Family Medicine  describing the nature of the error, and will provide a link back to the published article containing the error. A prominent corresponding link to the error statement will be added to the article containing the error. In the rare event of a retraction, a prominent mark and statement will be added to the the published article identifying it as retracted, in addition to the link to the editorial retraction statement. For errors that are disputed or pending further investigation,   the  Family Medicine  editors reserve the right to determine whether they will be handled by a series of letters to the editor and subsequent author replies, or by the publication of an expression of concern letter,  linked to the article in question in the same manner as corrections/retractions.

Copyright and Permissions 

Prior to publication, all authors are required to sign a copyright release form, transferring copyright to the Society of Teachers of Family Medicine (STFM).

Unless otherwise noted, all   Family Medicine   content is copyrighted by STFM and may not be reproduced without the written permission of STFM. If you would like to reproduce, reprint, or adapt material from   Family Medicine   for purposes other than nonprofit educational purposes, you must seek permission from the Society of Teachers of Family Medicine.  A permission fee is charged when material is to be used in another form of publication (eg, newsletter, textbook, manual, journal/magazine). The fee will be determined once the request has been reviewed. 

Advertising Guidelines

Family Medicine does accept advertisements for its journal,   Family Medicine , according to Society of Teachers of Family Medicine (STFM) advertising principles.

These advertising principles are applied by STFM to ensure adherence to the highest ethical standards of advertising and to determine the eligibility of products and services for advertising in the STFM digital publications. Advertising revenue is used to support the activities of STFM.

As a matter of policy, the STFM will sell advertising space in its publications when the inclusion of advertising does not interfere with the mission or objectives of STFM or its publications. To maintain the integrity of STFM publications, advertising (ie, promotional material, advertising representatives, companies, or manufacturers) cannot influence editorial decisions or editorial content. Decisions to sell advertising space are made independently of and without information pertinent to specific editorial content. STFM publications’ advertising sales representatives have no prior knowledge of specific editorial content before it is published. Placement of advertising adjacent to (ie, next to or within) editorial content on the same topic is prohibited. Complete policy details, including a list of advertising types that are and are not acceptable, can be found   here   (pdf).

Family Medicine  is committed to advancing efforts toward inclusion and antiracism in all journal-related activities. We endeavor to take the following actions to eliminate bias and  racism in our editorial processes:  

• Authors:   We encourage authorship from people of diverse backgrounds, particularly authors from minoritized groups (ie, underrepresented minority - URM) and historically excluded groups. Authors are encouraged to acknowledge and address systemic and structural problems identified in their work to advance diversity, equity, inclusion, and antiracism (DEIA) efforts.   
• Content: We encourage submission of manuscripts with person or population centered DEIA content. We encourage submission of work that moves beyond DEIA education and documentation of disparities to improving equity in health, education, physician advancement, and other areas.  
• Process: Submissions with DEIA content may be selected for further review by the DEIA associate editor whose focus is to promote inclusion and antiracism in the editorial process. We endeavor to increase peer reviewers with expertise in DEIA content.  
• Reflection: The editorial team will engage in discussions of historical and emerging social justice issues to ensure journal content reflects the evolving needs and experiences of physicians, learners and patients. We endeavor to increase individual understanding, self-reflection, and commitment to change practices that contribute to bias and racism.  
• Collaboration:   Our editorial team will work alongside other peer reviewed journals in an effort to intentionally critique and update our practices to advance inclusive and antiracist policies.   
• Language: We will regularly review and update guidance for authors and editors on the use of inclusive and culturally sensitive language in medical and science journals. We encourage authors to avoid labeling or stereotyping groups or populations based on opinions or bias.  

Permissions Requests

Academic use.

Family Medicine   has partnered with the Copyright Clearance Center to provide a web-based permission service.  If you would like to reuse material from   Family Medicine  for nonprofit educational classroom use, visit the   Copyright Clearance Center   and enter "Family Medicine" when asked for publication title to obtain permission to reuse copyrighted materials. 

If you would like to reproduce, reprint, or adapt material from   Family Medicine  for other purposes (apart from photocopying patient information handouts for nonprofit educational purposes), you must seek permission from the Society of Teachers of Family Medicine. Email your permission request to   [email protected].

Required on All Permission Requests

About the material you would like to use:

• Title of article/piece you want to use
• Name of author of material
• Name of publication
• Identify content (for example, do you want to use the entire article, only a table/figure, an illustration); provide a sample if possible

About your proposed use:

• Title of your publication, program, or product
• Name of publisher or sponsor
• Type/format of publication in which the content will appear (eg, newsletter, book, periodical, CD-ROM, website, ebook)
• Estimated number of copies to be printed or produced
• Whether the copies will be sold or free

Permission Fees

A permission fee is charged when material is to be used in another form of a publication (eg, newsletter, textbook, manual, journal/magazine). The fee depends on the amount of content being reprinted and will be determined once request has been reviewed. Payment should be made in US currency and must be received before permission is granted.

Editorial and Publishing Office

Family Medicine   11400 Tomahawk Creek Parkway Suite 240 Leawood, KS, 66211 Phone: 800-274-7928 or 913-906-6000

Editorial Team Fax: 913-800-5675 Editorial Team Email: [email protected]

Publishing Team Fax: 913-906-6096 Publishing Team Email: [email protected]

Managing Publisher: Traci Brazelton, CAE,  Society of Teachers of Family Medicine Publications Manager: Sam Grammer,  Society of Teachers of Family Medicine Editorial Assistant: Kathie-Jo Arnoff, Society of Teachers of Family Medicine

Family Medicine   is published on a monthly basis; combined issues are published in July-August and November-December. Family Medicine is sent electronically to all current STFM members at no additional charge and nonmembers can subscribe free by registering here.

Order Print Copies of Back Issues

Print copies of back issues from 2021 through 2022 (Volumes 53 and 54) may be available for purchase at a cost of $25 each. To purchase a single issue of the journal from those years,  email  Sam Grammer . 

Questions? Contact Sam Grammer at 913-800-5649, fax: 913-906-6096,   [email protected] .

Advertising Information

Classified and display advertising opportunities.

Family Medicine offers employment and display advertising opportunities online at Family Medicine Careers .

Maximize your reach to qualified candidates with   Family Medicine Careers   digital advertising opportunities. Promote your organization and job openings for family medicine educators and researchers on our recently updated online job board.  Explore the rates and posting options.

Mulltiple digital plans are available along with additional branding opportunities. Contact the Family Medicine Careers representative, Web Scribble, at (877) 414-7381 to develop the perfect customized package to meet your advertising needs and deliver you great candidates.

Family Medicine does accept advertisements for its journal,   Family Medicine , according to the Society of Teachers of Family Medicine (STFM) advertising principles.

These advertising principles are applied by STFM to ensure adherence to the highest ethical standards of advertising and to determine the eligibility of products and services for advertising in STFM digital publications. Advertising revenue is used to support the activities of STFM.

As a matter of policy, STFM will sell advertising space in its publications when the inclusion of advertising does not interfere with the mission or objectives of STFM or its publications. To maintain the integrity of STFM publications, advertising (ie, promotional material, advertising representatives, companies, or manufacturers) cannot influence editorial decisions or editorial content. Decisions to sell advertising space are made independently of and without information pertinent to specific editorial content. STFM publications’ advertising sales representatives have no prior knowledge of specific editorial content before it is published. Placement of advertising adjacent to (ie, next to or within) editorial content on the same topic is prohibited. Complete policy details, including a list of advertising types that are and are not acceptable, can be found   here   (pdf).

Family Medicine Readership

Family Medicine's 5,000 subscribers include more than 4,700 members of the Society of Teachers of Family Medicine. These STFM members are leaders within the primary care medical community—department chairs, residency program directors, predoctoral directors, and others—comprising an elite group of teaching physicians and faculty who create policies within today's medical community and influence the decision-makers of tomorrow. Family medicine educators turn to STFM for the latest educational research and resources, faculty development workshops, and management skill training.

Our members not only teach—influencing the residents and students who will become future family physicians—but also see patients, just like other family physicians. According to a recent membership survey, on average, our members spend about a third of their time seeing patients. Some members devote even more time to clinical activities. Here are some of the product categories these physician-educators are seeking more information about:

• Books : Family physicians are a prime market in the current medical environment. In many cases, STFM members are the decision-makers who determine which textbooks to use in their courses. Additionally, many of these physicians are authors of family medicine books and journal articles. Our audience is a medical publisher’s dream market!
• Conferences : Our journal is read by an audience dedicated to the value of continuing education, and these readers are likely to attend, as well as spread the word to other faculty and residents about valuable conferences.
• Medical and Practice Software :   Many of our members in community and university settings use electronic health record software, billing software, and other point of care tools.
• Other Business Services: STFM members often seek other services and products that go with business ownership, along with products and services specific to family physicians and family medicine educators, such as insurance and annuity plans, managed care company programs, and medical equipment.
• Pharmaceuticals : The educators of future family physicians are highly regarded as role models with tremendous influence over residents and medical students. Educating the educators about your products will provide a downstream benefit for you during this critical time when trainees are developing future prescribing habits.

Contact STFM

2024 © Society of Teachers of Family Medicine. All Rights Reserved.

• Campus News /

Medical College of Wisconsin Research Training Program in Vision Science Renewed by the National Institutes of Health

August 9, 2024

The Medical College of Wisconsin (MCW) Research Training Program (T32) in Vision Science has been approved for another five-year term by the National Institutes of Health (NIH) . The program, which began in 2002, will increase the number of NIH supported pre-doctoral positions available from three in the most recent five-year term to four annually.

The goal of the NIH T32 program is to prepare qualified trainees for careers that have a significant impact on the health-related research needs of the nation. Since the program’s inception, MCW has supported 40 pre-doctoral trainees. Program graduates have active careers in medicine and science and many continue to be actively involved in the field of vision, More than 60% of program’s graduates hold faculty-level positions at various prestigious institutions or have developed successful non-academic biomedical science careers, with more recent graduates continuing their training via various postdoctoral fellowship programs.

“We are thrilled to continue the long-standing success of our T32 training program,” says Elena Semina, PhD , Director of the Research Training Program in Vision Science and Professor of Ophthalmology and Visual Sciences . “Our goal is to prepare trainees for research careers in ocular and vision research and in both academic and non-academic routes. Our faculty group of mentors is well positioned to provide students a broad appreciation of the major features of the visual system, a contemporary understanding of the diseases that impact vision, and modern research skills and technologies for experimental work in the visual system.

MCW’s mentor group for the training program increases to 12 faculty members, including six new participants with highly innovative and dynamic research programs. The mentors span across several departments: ophthalmology and visual sciences, biomedical engineering (a partnership with Marquette University), cell biology, neurobiology and anatomy, and biophysics.

The group of mentors in the Research Training Program in Vision Science receive research funding from the NIH (primarily from the National Eye Institute ) as well as additional grants funded by various private and public vision/research foundations.

The T32 program is committed to training a diverse cadre of PhDs and our trainees are unquestionably prepared to lead successful careers in science.