Strict \introduction Screening programs account for a significant portion of healthcare activity. As complex interventions, they necessitate careful implementation to produce a net benefit. Primary care sees a lot of screening. Despite extensive research into intervention delivery in primary care, there is currently no synthesis of screening program delivery in this setting. This review aims to describe and evaluate screening program delivery in general practice and community services.
Analyses and methods We will use scoping review methods to investigate which components of screening programs are delivered in primary care and systematic review methods to locate and synthesize evidence on how screening programs, including barriers, facilitators, and strategies, can be delivered in primary care. We will include empirical studies of any design that considers screening programs in high-income countries based in part or entirely on primary care. From January 1, 2000, we will search 20 information sources, including those related to health (e.g., MEDLINE, Embase, CINAHL), management (e.g., Rx for Change database), and grey literature (e.g., OpenGrey, screening committee websites). Two reviewers will screen potential eligible studies’ citations and full texts and compare them to the inclusion criteria. Data from both qualitative and quantitative sources will be extracted in duplicate and analyzed using a best-fit framework approach. The mixed methods appraisal tool will assess the risk of bias in the systematic review.
Ethics and distribution There is no need for ethics approval. We plan to disseminate findings to academics via publication and presentation, decision-makers via national screening bodies, practitioners via professional bodies, and the general public via social media.
CRD42020215420 is the PROSPERO registration number.
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This study’s advantages and disadvantages
A scoping review, followed by a systematic review, will look at a wide range of issues concerning the delivery of screening programs in primary care.
Searching 20 databases and additional key publications will provide a thorough foundation for identifying relevant evidence.
The combination of quantitative and qualitative data will conceptualize screening delivery based on multiple paradigms.
Using a best-fit framework approach will provide diagrammatic answers to the review questions.
Due to limited resources, this review only includes English-language publications.
Screening is used to identify people who have or are at risk of having a specific condition in an otherwise asymptomatic population, to lower the risk of illness associated with that condition.
1–3 In high-income countries, official screening programs, such as breast cancer screening or newborn bloodspot testing, account for significant health spending and activity: for example, the UK National Health Service performed 21 million official screening tests in a population of 65 million in 2015. 4–7 These screening programs are typically supported by the general public, professionals, and policymakers, with the rationale that early detection may prevent illness. 3 8–10
Despite popular belief, there are numerous disadvantages to screening. One major source of harm is the incorrect identification of participants who do not have the condition (false positives) and the incorrect identification of participants who do have the condition (false negatives). Harm can also be caused by identifying conditions that may never cause illness (overdiagnosis) or treating conditions that may never change the outcome (overtreatment). 3 9–12 Screening programs actively approach people who have not sought medical help, which may have psychosocial ramifications. 3 6 Screening program delivery that is effective and efficient seeks to maximize benefits (including cost benefits) while minimizing harms. 3 7 13
The delivery of complex healthcare interventions, such as screening, has been studied by multiple disciplines under terms such as ‘implementation science’ and ‘translational research.’
14–16 A variety of theories, models, and frameworks have been developed to explain and guide the successful delivery of interventions to achieve impact at a low cost. 14 17–19 Initial relatively simple implementation theories17 20 have given way to increasingly complex models that consider multiple layers of agents, networks, and dynamics. 14 17 21 22 Simultaneously, there has been an increase in the number of empirical studies of healthcare intervention implementation and related guidance on how to design such studies. 14 18 19 21 23–25 However, no synthesis of these studies relevant to the delivery of screening programs, in general, has been published to date.
Primary care, which includes general practice and community care services, is central to the delivery of many screening programs (for example, cervical screening and general health checks),13 26-31 reflecting the health system’s prominent role in disease detection and prevention.
28 32–35 Primary care providers are familiar with the explanation of screening results and required referrals to specialist care, as well as the holistic management of illnesses that may be diagnosed through screening. 29 30 33 Primary care is more cost-effective in health systems that use it more extensively, and many health systems are expanding the role and nature of primary and community services. 36 As interest in new screening approaches grows, an expanded role in primary care can be expected. However, new programs may place additional strain on an already overburdened system. 37 38 and evidence on the effective implementation of screening in primary care is needed to ensure resource efficiency. 18
The scope of this review will begin with a review of the literature to determine which aspects of screening programs have been or could be delivered by general practice and community care services. It will then look at how such screening programs have been implemented in primary care and the consequences of different approaches. Evidence synthesis will generate screening program recommendations for policymakers, health professionals, and researchers. The terms ‘general practice’ and ‘family practice’ are synonymous,39 and ‘primary care’ refers to general practice and community services.
We will conduct a literature review to describe and critically evaluate screening program delivery in general practice and community services.
We will conduct two linked reviews in which we will answer the following questions:
In general practice and community services, what screening programs or components of screening programs have been or could be delivered?
What has happened due to different approaches to delivery in general practices’ delivery of screening programs or components of screening programs?
Our primary goal with question one is to create a definitive summary of the screening programs or components of screening programs that general practices and community services have delivered, are delivering, or have the potential to deliver. Because of global trends toward integration, we have included both general practices and community services. 40–43 This will provide important context for question two, which will have the primary goal of locating, critically appraising, and synthesizing evidence on approaches to the delivery of screening programs specifically in general practices, including a consideration of the various systems and strategies used, as well as the barriers, facilitators, and outcomes of these. These findings will allow us to make recommendations for implementing screening programs in general practice. We did not include community services in question two because we felt the influences on delivery would be too different from those in general practice to provide meaningful recommendations.
Furthermore, we will concentrate on screening for primary prevention because these typically involve larger systems and greater coordination and affect a larger proportion of the population.
Analyses and Methods
To answer question one, we will conduct a systematic scoping review because the goal is to map screening activities that have occurred in primary care.
44 To answer question two, we will conduct a systematic review, including a risk of bias assessment. 45 We anticipate locating relevant qualitative and quantitative data in both reviews: we will use a best-fit framework approach to guide data synthesis (see below). 46–48
Monitoring and reporting
The scoping review for question one will be carried out and reported following the statement Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-Scoping Review (SCR).
44 The PRISMA statement will be followed in conducting and reporting the systematic review for question two. 49
This protocol follows the PRISMA-P guidelines50 and has the PROSPERO51 registration number CRD42020215420.
Criteria for Eligibility
Because of the broad scope of these reviews, eligibility criteria were iteratively developed through preliminary searches, examination of returned records, and discussions among the authors about areas of contention.
We will include studies involving primary care institutions, staff, systems, or actions (e.g., policies, communications, etc.). These include community services such as pharmacies and outreach programs for question one. These will be limited to general practices for question two.
Eligible studies will describe the components of screening programs implemented in primary care for question one. For question two, studies will describe and evaluate the various approaches to screening program delivery in general practice. For question two, studies examining barriers, facilitators, systems, strategies, or other features related to the delivery of screening programs or components of screening programs will be considered. External influences such as international policy or patient attitudes may impact screening delivery in general practice; however, studies on such aspects will be included only if they focus on how these relate to screening implementation in general practice. This is done to keep the focus on screening components under the control of general practice decision-makers.
For both questions, we will concentrate on screening programs that adhere to the widely accepted and stated general definition: the process of identifying people with or at risk of a particular condition in an asymptomatic population to reduce the risk of ill health associated with that condition.
1–3 The main distinction is that screening is done to prevent morbidity or mortality. As a result, we will only look at programs with a clear system for managing the patient’s results, from additional tests to treatment and follow-up. Polygenic risk scores and newly marketed, directly marketed screening tests that only estimate future disease risk and no clear management plan will be excluded. 3 52 We will also include only screening programs that use systematic invitations to an eligible population and exclude programs that only use opportunistic invitations. 3 We will only research screening programs for primary prevention.
There is no need for a control group.
Phenomena and results
Included studies will describe the types of screening programs or components of these screening programs delivered within primary care for question one. Question two is concerned with investigating how screening has been delivered in general practice and the outcomes of various approaches to delivery. The systems and strategies used to deliver screening, the barriers and facilitators of such approaches, and why such approaches were taken are all potential phenomena and outcomes of interest. Some studies will also report on the effects and outcomes of these phenomena. These are not required to be included and could be clinical (for example, changes in mortality) or implementation-related (e.g., changes in attitudes, reach, or maintenance). 19 24
Types of research
Primary data collection or secondary analyses of primary data will be included in empirical studies. All study designs will be considered, including interventional (including randomized controlled trials and quasi-experimental designs), observational (including cohort studies, case-control studies, and cross-sectional studies), qualitative, mixed methods, case reports, and case studies. For example, conference abstracts and grey literature do not require peer review. Studies that do not involve primary empirical research (for example, reviews and editorials) will be excluded; if they are discovered during our search, their reference lists will be reviewed for eligible primary studies. Letters with a preliminary study may be included.
Included studies must be related to primary care. This can be divided into two categories in high-income countries, which are the focus of this review: general practice (health professionals in a local health facility, including family practitioners, who provide some continuous care for all conditions) and community services (other services that provide local health services such as pharmacies and community nursing).
In response to question one, both general practice and community services are interesting because they are being integrated. It will be useful to note their potential in delivering screening programs. It will also allow us to create a map of screening activities that differentiates them. Only general practice will be of interest for question two because issues affecting delivery in general practice were thought to be too different from those in community services. Thus a combined synthesis may not provide useful recommendations.
Characteristics to report
To reflect the current role of primary care in the delivery of screening programs, studies published after January 1, 2000, will be included.
Criteria for exclusion
Studies that have not been published in English.
Reviews and editorials are examples of secondary research.
Personal communications and drafts are examples of unpublished material.
Publications that discuss screening delivery but do not explicitly state that they are based on primary empirical findings.
Studies of screening programs with no clear management plan for results, such as those that use polygenetic risk scores to provide only an estimate of future disease risk, and have no clear management plan. Screening for genetic disorders where the patient’s management is clear after the results are included, such as BRCA 1 or 2.
Studies on secondary or tertiary prevention screening in which patients are invited because they have a disease that predisposes to the condition being screened for, such as diabetic retinopathy screening.
Opportunistic screening programs and commercial genetic screening tests are studies in which participants were not systematically invited for screening.
Studies on the delivery of screening in settings other than primary care, such as hospitals or central public health institutions.
According to the World Bank, studies with all data are based in low-income or middle-income countries.
43 53 54
Databases are sources of information.
Table 1 shows the information sources used in their broadest coverage dates, which were searched from September to November 2020. These sources were chosen after discussions with an information specialist, the review team, and members of the UK National Screening Committee.
POPUP VIEW INLINE VIEW
Table 1: Information sources for the review of screening program delivery in primary care.
Other sources of publications (see table 1) will be recommended by the review authors based on their experience in health screening research and practice and their initial examination of the results of scoping searches. We emailed well-known experts on screening and its implementation from the UK National Screening Committee. 3 As needed, snowball email contact with additional experts suggested by the initial experts will be made. We will also screen reference lists of relevant review articles retrieved by our search to find additional eligible primary studies.
Strategy for Search
An information specialist (IK), a general practitioner (RNM), a health services researcher (JB), and a reviews specialist (SK) collaborated on a draft search strategy, with all authors contributing terms. Searches were piloted in all research databases used in this review, records were examined, key papers were checked for their presence, and the strategy was iteratively refined due to this process. Screening, primary care, and implementation were combined using ‘and’ operators. Each concept consisted of controlled vocabulary terms (for example, Medical Subject Headings – MeSH terms) and free-text terms combined with ‘or’ operators. The terms will be translated for each database, including using controlled vocabulary. Both questions one and two will be searched using the same strategy. A draft of this in Ovid MEDLINE format is shown in online supplemental file 1.
Additional material [bmjopen-2020-046331supp001] .pdf]
Records of research
Covidence55 will be used to store and manage records returned from primary searches. Endnote,56 NVivo,57 Microsoft Word, Microsoft Excel, and Microsoft PowerPoint will also be used.
The selection procedure
Records will be downloaded and screened in Covidence. The titles and abstracts of the records returned from the searches and additional publications discovered through other means will be screened (blinded and in duplicate) by independent reviewers following the eligibility criteria for questions one and two. If disagreements between the reviewers cannot be resolved through discussion, a third reviewer will arbitrate the final decision. The full texts of the remaining records will be blinded and duplicate-screened for potential relevance using the same eligibility criteria. If there is still disagreement after discussion, a third reviewer will decide.
Items of data and phenomena/outcomes
Although data in this mixed studies review may include unanticipated categories, data extracted for all studies will include the following:
Reference, first author, year, funding, the country from which data were collected, sample size, intervention/purpose of the study, health condition screened for, primary care staff involved, comparator, data collection method, and study category according to the mixed methods appraisal tool (MMAT)58—’qualitative,’ ‘quantitative non-randomized,’ ‘quantitative descriptive,’ or mixed methods.
Key demographics, such as age, health status, and socioeconomic status, where applicable.
Where applicable, key contextual factors include new policies, health emergencies, responses to significant events, economic concerns, and specific health systems.
Two independent reviewers, blinded and in duplicate, will extract data into a Microsoft Excel spreadsheet. The two reviewers will discuss disagreements and, if necessary, arbitrate by a third reviewer. Data relevant to the review questions will be extracted similarly, followed by synthesis guided by the best-fit framework approach. It is not possible to precisely predict the data available for extraction and how it will be classified for synthesis, but potential areas of interest include:
Setting (general practice, community service), the relevant component of a screening program, and related outcome data are required for question one.
The phenomena measured (e.g., perceived barriers, audit effects)
The types of outcome (qualitative or quantitative)
The outcome data
Direct quotes from participants, themes generated by the authors supported by data, and any quantitative data will be extracted as qualitative data.
Individual studies may be biased.
The MMAT58 (see online supplemental file 2) will be used to assess the risk of bias at the study and outcome levels for studies included in response to question two. This will be done blindly and in duplicate by two independent reviewers. Disagreements will be resolved through discussion, and if no agreement is reached, a third reviewer will arbitrate.
Additional material [bmjopen-2020-046331supp002] .pdf]
Synthesis of data
The most appropriate framework approach
A best-fit framework approach will be used to synthesize qualitative and quantitative data.
47 48 This method was created in response to concerns about the resources needed to conduct qualitative syntheses using framework synthesis, thematic synthesis, or meta-ethnography. A framework synthesis may necessitate the authors’ opinions, which are not always transparent. In contrast, thematic synthesis or meta-ethnography may necessitate extensive inductive analysis, which can be prohibitively time-consuming in large reviews. 48 The best-fit framework approach uses a coding framework built from relevant theories and models identified in the literature to provide a quick and transparent method for synthesizing qualitative data. As a result, rather than generating theories from scratch, it facilitates an examination of review findings in light of pre-existing theories (with the potential for further development of these theories). The best-fit framework approach combines the deductive methods of framework synthesis (by coding data to a priori themes) and the inductive methods of meta-ethnography (for data that does not code to a theme in the framework), is particularly useful when there are relevant theories in the literature. Still, they have not been refined for the specific context of the review question. The method generates a diagrammatic response to the review question that is intended to be simple and clear for policymakers.
A best-fit framework approach to synthesis thus provides several benefits for this review. Notably, theories and implementation models are available in the literature but have yet to be tested and refined in the context of screening in general. We recognize that best-fit framework approaches were originally designed for qualitative syntheses, but we are using them in a relatively novel way for a mixed studies review. However, both qualitative and quantitative data can be used to enrich and refine a synthesis framework, and combining both is simple when, as in this case, quantitative data are likely to be too varied to allow for a meaningful meta-analysis.
Looking for models that best-fit frameworks
This review will generate a best-fit framework to guide data synthesis for each research question. To create the initial frameworks, we will systematically search the literature for existing models relevant to the review questions. These searches will be conducted in addition to the main literature search described above for the review. The models may be related to specific core features of the review questions but not always to the specific context of interest. The most relevant models will be purposefully chosen and synthesized if multiple models are discovered. The search for question one will aim to find publications relevant to creating a pathway of steps in a screening program. The search for question two will aim to locate publications relevant to the delivery of screening programs. We will generate initial search terms using the mnemonic Behaviour of interest, Health context, Exclusions, Models, or theories (BeHEMoTh), which was developed to guide systematic searches for theories. 48 59 We will convert vague terms into appropriate search strings for two major databases: EBSCO CINAHL and Ovid MEDLINE (see online supplemental file 3 for Ovid MEDLINE search terms for question one and online supplemental file 4 for question two).
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Additional material [bmjopen-2020-046331supp003] .pdf]
Additional material [bmjopen-2020-046331supp004] .pdf]
The BeHEMoTH search strategy will be used to select relevant located models, which will adapt to the approach outlined in the original description of the best-fit framework method48.
59 We will conduct systematic searches to find relevant models, as we did with the original best-fit framework approach. However, we will broaden the search with controlled vocabulary terms, add key papers recommended by the research team, and purposefully select the final included models to increase concept variation and to represent the various levels of delivery in screening programs (e.g., public health management and general practice staff). We will also make use of relevant models from the grey literature. 48
The best-fit frameworks are used for synthesis.
As a result, best-fit frameworks for questions one and two will be generated separately. The final frameworks (i.e., the results of the model searches), representing a single pre-existing model or a synthesis of multiple pre-existing models, will then be used as a framework for coding data extracted from included studies. 47 Extracted quantitative and qualitative data will be coded against the framework concepts that best fit. Relationships between concepts that emerge from the data will also be noted, which will aid in understanding how concepts relate to one another. A new code will be created where an appropriate concept does not exist. This code will be either original or derived from another model discovered while searching for the best-fit framework. Concurrent thematic analysis of these new codes may result in the refinement of existing concepts in the best-fit framework, the creation of new concepts, or the alteration of relationships between them, as appropriate. The framework concepts that have become obsolete due to this process may be removed. 48 This will result in a framework refined by qualitative data and described by quantitative data for each review question, which will be narratively synthesized where there is sufficient information. A new model displaying the relationships between concepts discovered during this process will be created to answer each review question. Data, codes, themes, and models will be discussed at regular team meetings, actively encouraging analyses from various perspectives and assumptions, thereby increasing the robustness of the findings. Figure 1 depicts an overview of the best-fit framework approach used in this review.
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Figure 1: An explanation of the role of best-fit frameworks in the scoping and systematic reviews of screening program delivery in primary care.
The original best-fit framework method authors advised performing a sensitivity analysis after eliminating low-quality studies.
48 However, this is not appropriate for this review: the quality of qualitative studies is frequently assessed solely on the quality of reporting, and it is widely acknowledged that for complex interventions60, even ‘low-quality’ studies may provide useful indications of relevant concepts that require further exploration. However, we will use the risk of bias assessment to guide our interpretation of the findings for review question two.
Meta-biases and trust in cumulative evidence
Because of this review’s variety of evidence types and its less usefulness in a complex exploratory review like this, publication bias will not be assessed. We hope to limit this by including grey literature and databases with conference abstracts. 61 For review question two, we will reflect and comment on individual study bias risk, recurring types of bias, and potential effects on overall conclusions, including how they might cause differences in study findings. A GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) Score informed by the MMAT scores of individual studies that address the same recommendation can be used to describe the recommendation’s strength. However, due to the wide range of studies that may help answer the review question, such a score may not be useful; in this case, the process will not be carried out.
Patient and public participation
Because this review will primarily benefit healthcare providers and decision-makers, patients and the general public were not involved in its design or writing. As a result, we have included authors in these roles. However, we intend to disseminate the review’s findings through social media and directly to relevant contacts in patient and primary care organizations.
Ethics and distribution
Because all data is publicly available, ethical approval is not required. If significant changes are required, the nature, rationale, and date will be recorded in PROSPERO. The research findings will be published in peer-reviewed journals and presented at an international conference. Publications will be distributed via social media, networks, and websites used by reviewers and institutions, reaching academics, policymakers, and the general public. They will also be distributed to members of various national screening committees and primary care organizations via established channels.