A scoping review protocol of evidence-based guidance and guidelines published by general practitioner professional organisations

Introduction: General practitioners (GPs) strive to use a patient centered approach to achieve shared decision making by integrating clinical evidence, clinical judgement, and patient priorities. In order to achieve this standard of care, GPs require relevant, up to date and high quality evidence. Currently there is a gap in the literature regarding the role of GP professional organisations internationally in producing and publishing evidence based guidance and clinical guidelines for GPs. This protocol outlines a scoping review to identify what evidence-based guidance is produced by general practitioner professional organisations internationally in terms of topic content, the structure and methods used to develop guidance and ways of disseminating this guidance, to support general practice clinical decision making. Methods: This scoping review will be conducted using the framework proposed by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for scoping reviews (PRISMA-ScR), will be used to guide the reporting. Two researchers will search electronic databases (Medline, Embase, Cochrane Library and Scopus), grey literature sources and contact international GP professional organisations directly to identify appropriate studies for inclusion. Key information will be categorised and classified to generate a summary of the methods used internationally to develop and implement evidence-based guides for general practitioners and a narrative synthesis will be conducted. Conclusions: This scoping review will examine current practice internationally regarding the role of General Practice professional organisations in producing and publishing clinical guidelines and evidence based guidance to support general practitioner’s clinical decision making to benefit patient care.


Introduction
General practitioners (GPs) require evidence-based guidance to support patient care [1][2][3][4][5] .GPs have a unique role in society, practicing medicine in the context of the family and community 6 .GPs strive to use a patient centred approach to achieve shared decision making by integrating clinical evidence, clinical judgement, and patient priorities 7,8 .There are differences internationally in healthcare systems and the cultural context in which GPs practice, but the role of the GP internationally has similarities in that GPs are 'primarily responsible for the provision of comprehensive and continuing care to every individual seeking medical care irrespective of age, sex and illness 9 GPs in some countries have a gatekeeper role, authorising access to specialty care, hospital care, and some diagnostic tests 10 .
Clinical practice guidelines are systematically developed statements, based on a thorough evaluation of the evidence, to assist practitioner and service users' decisions about healthcare 11 .However, a review of 45 UK guidelines reported that many guideline recommendations were based on studies with little or no relevance to primary care 12 .GPs are more likely to use guidelines where the evidence is perceived to be applicable to primary care and where there has been GP input at the guideline development stage 13 .
Internationally, GP professional organisations, as key GP opinion leaders, play a varied role in the clinical practice guideline ecosystem.First, in certain countries, GP professional organisations develop 'de novo' clinical guidelines.For example, the Dutch College of General Practice (NHG) develop de novo clinical guidelines for GPs across a range of primary care presentations and commonly managed conditions 14 .Second GP professional organisations may be approached to endorse clinical practice guidelines developed by external organizations and groups 15 .Third, GP professional organisations may disseminate materials to GPs based on national or international guidelines as part of an adopt or adapt approach [16][17][18] .While methodological guidance exists to support the process of adoption and adaption of guidelines, there is a need to have standardisation of this process to facilitate reproducibility and reduce duplication of effort.Time pressure and increased workload are established barriers to GP implementation of clinical guidelines and evidence 19 .GP professional organisations are well placed to support GPs to assimilate required evidence through the provision of easily accessible, high level clinical guideline summaries and evidence synopses.However what role, if any, GP organisations take in the dissemination of such evidence is unknown.This gap in the literature limits the ability of GP professional organisations to share both experience and expertise in how best to support GPs in their clinical decision making to support evidence-based patient care.
The aim of this scoping review is to identify what evidence-based guidance is published by GP professional organisations internationally to support GPs in their clinical decision making.The objectives are i) to identify the topics covered, both clinical and non-clinical; ii) to review the methods used to develop evidence-based guidance and/or clinical guidelines and how these guidance documents are structured and, iii) to explore how evidence is disseminated to GPs.

Scoping review framework
This scoping review will follow the framework proposed by the Joanna Briggs Institute (JBI) [20][21][22][23] .While, the overall conduct of the scoping review is informed by the JBI framework, the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for scoping reviews (PRISMA-ScR) will be used to guide the reporting of the scoping review 24 .
As this is a scoping review it will be designed to identify the range of the evidence available and will be represented as a mapping of the identified data, without the act of synthesis or particular reference to methodological quality of relevant studies 25 .

Amendments from Version 2
We would like to thank the reviewer for his comments and suggestions.
We have addressed each comment by the reviewer on a point by point basis in the responses.

Specific amendments made to the protocol include;
The methods section has been updated to clarify that all aspects of the search will be completed in tandem.By completing the database search, grey literature search and key informant survey in parallel we aim to overcome the challenges of GP professional organsation guides not always being published in peer reviewed publications and also the heterogeneity of the nomenclature associated with the search.
In the discussion section we have expanded on the potential impacts of the findings to include standardisation of guidelines internationally and reducing the duplication of effort by sharing of information between GP professional organisations internationally.

Any further responses from the reviewers can be found at the end of the article
Stage 2: Identifying the relevant studies Table 1 contains the eligibility criteria for the scoping review.Articles will be included where they are an evidence-based guidance document or guideline produced by a national general practice professional organisation.These guidance documents must support GPs clinical decision making and patient clinical care and be published in the last 10 years for currency.For the purposes of this scoping review 'published' refers to guidance documents that are made available by GP professional organisations, either freely on their websites or on a membership basis or through peer reviewed publications.These documents can be developed de novo or through adaptation processes.It does not include guidelines that are collaborations with or endorsed by other, non GP guideline producing organisations.No language restrictions will be applied.

Search strategy
Given the nature of the topic, the fact that many guides may not be published as peer reviewed publications and considerable heterogeneity of the nomenclature (e.g.guides versus guidance versus clinical guidelines), the search strategy will identify both peer reviewed studies and grey literature.This will be achieved through a combination of bibliographic database searching, grey literature searching and contacting key informants.All these processes will be conducted in tandem and are not sequential.

Bibliographic database searching
The bibliographic database searching will follow a three step strategy, as per JBI 20 .A copy of the search strategy is shown in Table 2.
The first step, the limited search, will include searching two appropriate online databases (Medline and Embase).An analysis of the text words in the titles and abstracts of retrieved papers will be conducted, and of the index terms used to describe the articles.
The second step will use all identified key words and index terms to perform a second search of all the following databases: Medline, Embase, Cochrane Library and Scopus to identify peer reviewed research papers relating to our aim.This step will be conducted with input from an information specialist.
Thirdly, reference lists of included articles will be searched for additional relevant articles.

Grey literature search
Grey literature searching will be conducted by searching 'Guideline Central' and 'NHS Evidence Search' using combinations of the key words and index terms used in the bibliographic database search.

Contacting key informants
Key informants in GP professional organisations, as per the definition of general practice outlined in Table 1, will be contacted through professional links via the Irish College of General Practitioners (ICGP) and links with the European Society for Quality and Safety in Practice (EQuiP) in WONCA Europe.
The final included studies for screening will be downloaded to a reference management software package (EndNote X9) and duplicates removed.

Stage 3: Study selection
Titles and abstracts will be screened for inclusion against the inclusion criteria for the review (Table 1).For those that appear to meet the inclusion criteria, full text articles will be retrieved and screened against the inclusion criteria.Those articles that fulfil all the inclusion criteria will be included in the review.
The above steps will be completed by two reviewers (EOB and SD).They will work independently initially and then come together to compare results.Any discrepancies will be resolved by consensus and if consensus is not reached will be referred to a third reviewer (EW).
Studies that do not meet the inclusion criteria will be excluded.Reasons for the exclusion will be kept and presented as part of the flow diagram.
The final search results will be outlined in a PRISMA flow diagram from the PRISMA-ScR statement, which will be accompanied by a narrative description of the process.

Stage 4: Charting the data
This scoping review is designed to identify the range of the evidence available and represent this as a mapping of the identified data, without the act of synthesis or with particular reference to methodological quality of relevant studies 25 .For data extraction the standardised template from the JBI methodology guidance for scoping reviews will be adapted for use 20 .Key information will be organised in categories based on data from organisational characteristics (evidence source details) e.g., name, country, role, and membership.Details extracted from the source of evidence; characteristics related to the methods (e.g.general description of the method of development), the clinical topics covered and approach to structure and presentation.Modes of dissemination will be recorded as well as implementation strategies.
These will be classified and categorised to generate a map of the methods used internationally to develop evidence-based guides for general practitioners and a narrative synthesis conducted.
As part of this process one reviewer will independently chart the data from the retrieved articles using the data charting form developed for this review (Table 3).The second reviewer will check a sample of 20% of the charted data.They will then discuss the results and update the data charting form in an iterative process.Reasons for changes will be outlined and presented as an appendix as part of the review.If there are any inconsistencies these will be reviewed by a third reviewer.• No language restriction • For the purposes of this review the following definition of general practice is used 'General practitioners/family doctors are specialist physicians trained in the principles of the discipline.They are personal doctors, primarily responsible for the provision of comprehensive and continuing care to every individual seeking medical care irrespective of age, sex and illness.They care for individuals in the context of their family, their community, and their culture, always respecting the autonomy of their patients.They recognise they will also have a professional responsibility to their community.In negotiating management plans with their patients they integrate physical, psychological, social, cultural and existential factors, utilising the knowledge and trust engendered by repeated contacts.General practitioners/family physicians exercise their professional role by promoting health, preventing disease and providing cure, care, or palliation.This is done either directly or through the services of others according to health needs and the resources available within the community they serve, assisting patients where necessary in accessing these services.They must take the responsibility for developing and maintaining their skills, personal balance and values as a basis for effective and safe patient care' 9 .
• Patient clinical care Exclude guidance relating to practice management and other non-clinical topics

Dissemination
We intend to disseminate the results through publication in a peer-reviewed journal and conference presentations.

Study status
Database searches have been completed and title and abstract screening is currently underway.

Ethics
Ethical approval is not required for this scoping review.

Discussion
This scoping review will provide an overview of the evidence-based guidance produced and disseminated by GP professional organisations internationally.This scoping review can contribute to the evidence base for supporting GPs clinical decision making to benefit patient care.Furthermore, the findings of this research can identify potential areas for standardisation internationally to facilitate reproducibility and reduce duplication of effort.The findings of this scoping review will inform future research on the content, presentation dissemination and implementation of evidence-based guidance for GPs.Stage 5: Collating, summarising and reporting of results Results will be reported using the PRISMA-ScR guidelines 24 .
Each research question will be reported separately and presented in a tabular form and as a narrative summary.This narrative description will be used to synthesise the study findings based on themes that are generated from the extracted data.
the role of its professional organisations worldwide.I have one major and a few minor comments.
One major comment concerns the search strategy.The authors start with searching online databases and then targeting professional organisation contacts.I would suggest reversing the order.As general practice guidelines are often not included in medical databases, the best way to identify them is to contact professional organisations, for instance, by using the WONCA Network and/or GIN Network.The websites of member organisations could be explored for guidelines published or links to guideline databases.In addition but as a second step, online databases could be searched.In contrast to systematic reviews, a scoping review does not aim to be complete, so efforts could be saved by limiting the search strategy.If the authors still decide to start with searching the online databases, it would be recommended to only follow step 1 as exploration.
Minor comments are: There is no definition provided of 'guidance'.NICE uses this as an umbrella term, including (evidence-based) guidelines, others use the term to describe all other tools to support decision making in clinical practice that are not evidence based, in contrast to guidelines.I would suggest limiting the review to guidelines, which are evidence-based by definition (according to IOM).

1.
The term 'published' also needs clarification.This can be on paper or digital.In the legal context, the term 'endorsed' or 'approved' is more relevant than 'published' as this means that the professional needs to know and to follow the guideline in principle.The term 'published' is more vague.It would be interesting to focus on those guidelines that are part of a programme or set of guidelines used for education, training, and evaluation.As this is a scoping review, the scope can be changed or refined during the study if more focus is desirable to answer the research question.

2.
The search strategy identifying general practice could be expanded with terms as 'Primary Health Care' or 'Physicians, Primary Care'.This is broader than 'General Practice' and 'Family Practice' but some countries do not use these terms. 3.
In Discussing the potential impact of the findings of this study, the authors could discuss the opportunities to share guidelines and their supporting evidence internationally to reduce duplication of efforts.

Are the datasets clearly presented in a useable and accessible format? Yes
Is the rationale for, and objectives of, the study clearly described?Yes

Are the datasets clearly presented in a useable and accessible format? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: general practice, medical education, dementia care, scoping review, qualitative research I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Version 1
comments on a point by point basis below.

Comment
I have some concerns about this study, and its potential to provide useful evidence.In particular, I do not feel that the rationale for focusing upon the role of GP professional organisations in guideline production is well described.I think that the researchers are suggesting that guidelines produced specifically by GP professional organisations will somehow be better/more applicable than guidelines produced by other organisations, but this case is not made.

Response
The rationale for focusing on GP professional organisations is to examine current practice internationally regarding the role of GP organisations in producing and publishing clinical guidelines and evidence based guidance for GPs.There is currently a lack of evidence as to what is being published by GP professional organisations internationally in terms of evidence based guidance and clinical guidelines for GPs to use in their clinical practice.Our initial literature search shows international variation in the role of GP professional organisations in publishing guidelines and evidence based guidance for GPs.For instance in the Netherlands, de novo clinical guidelines are developed and published by the Dutch College of GPs on a range of relevant topics whereas in other countries such as the UK clinical guidelines, aimed at GPs are published by central clinical guideline agencies such as NICE and SIGN while the Royal College of GPs focuses on the publication of other evidence based guidance for GPs.

Internationally, GP professional organisations, as key GP opinion leaders, play a varied role in the clinical practice guideline ecosystem. First, in certain countries, GP professional organisations develop 'de novo' clinical guidelines. Second GP professional organisations may be approached to endorse clinical practice guidelines developed by external organizations and groups. Third, GP professional organisations may disseminate materials to GPs based on national or international guidelines as part of an adopt or adapt approach. While methodological guidance exists to support the process of adoption and adaption of guidelines, there is a need to have standardisation of this process to facilitate reproducibility and reduce duplication of effort.
Evidence shows that involving clinicians in guideline production relevant to their clinical practice and understanding the context in which the guidelines are to be implemented are very important aspects of ensuring clinical guidelines are implemented in practice.
Understanding the role of GP professional organisations internationally in the production and publishing of clinical guidelines can inform best practice in this area and lessons can be shared regarding how different countries approach this issue and how that impacts on implementation.
GPs are more likely to use guidelines where the evidence is perceived to be applicable to primary care and where there has been GP input at the guideline development stage To capture the implementation of guidelines published by GP professional organisations internationally a key informant survey of GP professional organisations internationally will be conducted to further inform this scoping review.This will focus on the methods employed by different GP professional organisations in developing guidelines/evidence based guidance, how this is disseminated to GPs and the processes supporting implementation in clinical practice.This approach will give a rounded view of the utility of different approaches to guideline production and publication by GP professional organisations internationally.
The introduction has been updated to include a discussion of the barriers to guideline implementation and the possible role GP professional organisation have in facilitating their use.
Time pressure and increased workload are established barriers to GP implementation of clinical guidelines and evidence.GP professional organisations are well placed to support GPs to assimilate required evidence through the provision of easily accessible, high level clinical guideline summaries and evidence synopses.However what role, if any, GP organisations take in the dissemination of such evidence is unknown.This gap in the literature limits the ability of GP professional organisations to share both experience and expertise in how best to support GPs in their clinical decision making to support evidence-based patient care.

Comment
In addition, I think that current professional focus is generally more upon how you manage patients with more than one condition, and in these circumstances, disease specific guidelines are less applicable.

Response
Multimorbidity is one important area for GPs to have access to up to date information and there are already a number of guidelines developed to support GP decision making in this area e.g.UK NICE guideline for the clinical assessment and management of multimorbidity.
This scoping review will provide an overview of the topics that GP professional organisations develop clinical guidelines and evidence based guidance for GPs and will answer the question as to what topics GP professional organisations are prioritising for their GP members.

Comment
Finally, the authors do not provide any research questions.I would recommend that they do this before embarking on their review

Response
The overarching research question and objectives for this scoping review are outlined in the Methods section; scoping review framework; stage 1; identifying the research question.
For ease of reference we include the research question and review objectives again here; GPs are more likely to use guidelines where the evidence is perceived to be applicable to primary care and where there has been GP input at the guideline development stage.
'The role of the GP in the healthcare system also has an impact'.....Consider expanding on this sentence to explain to the reader what impact is being discussed.

Response
Introduction paragraph 2 has been updated to put both healthcare system and role of GP as gatekeeper into context 'There are differences internationally in healthcare systems and the cultural context in which GPs practice, but the role of the GP internationally has similarities in that GPs are 'primarily responsible for the provision of comprehensive and continuing care to every individual seeking medical care irrespective of age, sex and illness' 'GPs who are gatekeepers are more likely to require GP orientated guidelines'...Perhaps this statement could also be further explained?

Methods:
Search Strategy: Table 1 Eligibility criteria -consider adding rationale why you're excluding papers with <=2 authors.Is that necessary?

Response
Thank you.The author number restriction has been removed.
Contacting GP professional organisations -Can you further identify which countries/regions will be included in this contact and justify why?

Response
The Key Informant Survey will be circulated to GP professional organisations colleges in Europe, USA, Canada, Australia and New Zealand.We are targeting national GP professional organisations in countries that have a GP system in line with the WONCA definition of General/Family Practice (Table 1 of protocol).See Methods, Search Strategy Stage 2 for updated text.Various avenues will be utilised to contact key informants including WONCA Europe contacts.
Has the protocol been registered?e.g.open science framework/prospero.

Response
Prospero does not accept registration of Scoping Review Protocols.The review has been registered with Open Science Framework.

Stage 1 :
Identifying the research question Overarching research question: What evidence-based guidance is published by general practice professional organisations to support GPs clinical decision making?Objectives: a.What are the content topics that the organisations are providing?b.What are the methods for developing these guides?c.What are the structures of the guides and how are they presented?d.How are these guides disseminated to GPs?

Table 1 . Eligibility criteria for inclusion in the review.
In order to be considered evidence-based, guidance documents will be included where they explicitly state they are based on a review of the literature (including systematic reviews, scoping reviews, rapid reviews, narrative reviews) Must be peer reviewed, reviewed by committee or experts.Definition of Evidence based guidelines 'systematically developed statements to assist practitioner decisions about appropriate healthcare for specific clinical circumstances' Evidence based as they 'use the results of systematic literature reviews in

Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests:
No ResponseGiven the amendments made to more clearly outline the overall rationale for this study we hope that the reasoning for the choice of study design is also clearer now.A scoping review is defined as a review that is designed to address a broad research question by mapping a body of literature in that area and also to identify gaps in the research knowledge area (Peters, Godfrey et al. 2015) Scoping reviews are used not only to determine the extent of the research in a particular area but also the way the research was conducted.As such, we believe it is the appropriate design to answer the research question for this review; 'What evidence based guidance and guidelines is published by general practice professional organisations to support GPs clinical decision making'.By supplementing the scoping review of the literature with a targeted survey of GP professional organisations internationally the review will be able to provide data on other key aspects of guideline production, dissemination and implementation by GP professional organisations.While the importance of evidence-based guidance to support patient care is made and also the different approaches used internationally, I feel the authors need to expose and highlight the gap in research.Have any similar reviews been undertaken before or are any scoping/systematic reviews currently ongoing?What literature is out there on the aims/objectives of this study?'Therole of the GP in the healthcare system also has an impact'.....Consider expanding on this sentence to explain to the reader what impact is being discussed.'GPswho are gatekeepers are more likely to require GP orientated guidelines'...Perhaps this statement could also be further explained?No competing interests were disclosed.
Contacting GP professional organisations -Can you further identify which countries/regions will be included in this contact and justify why?Has the protocol been registered?e.g.open science framework/prospero.

have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
Thanks for the opportunity to review this interesting scoping review protocol.While the importance of evidence-based guidance to support patient care is made and also the different approaches used internationally, I feel the authors need to expose and highlight the gap in research.Have any similar reviews been undertaken before or are any scoping/systematic reviews currently ongoing?What literature is out there on the aims/objectives of this study?ResponseThere is currently a lack of evidence as to what is being published by GP professional organisations internationally in terms of evidence based guidance and clinical guidelines.There appears to be international variation in the role of GP professional organisations in publishing guidelines and evidence based guidance.For instance in the Netherlands, de novo clinical guidelines are developed and published by the Dutch College of GPs on a range of relevant topics whereas in other countries such as the UK, clinical guidelines aimed at GPs are published by central clinical guideline agencies such as NICE and SIGN while the Royal College of GPs focuses on the publication of other evidence based resources for GPs.See paragraph 3 and 4 of Introduction, research gap highlighted by expanding on the above points and also making clear the rationale for this review.Clinical practice guidelines are systematically developed statements, based on a thorough evaluation of the evidence, to assist practitioner and service users' decisions about healthcare.However, a review of 45 UK guidelines reported that many guideline recommendations were based on studies with little or no relevance to primary care.