The role of general practitioners in the management of patients with acne using isotretinoin: Protocol for a scoping review of clinical practice guidelines

Diarmuid Quinlan; Laura Sahm; Linda O'Keeffe; Miriam Santer; Tony Foley

doi:10.12688/hrbopenres.13914.1

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Study Protocol

The role of general practitioners in the management of patients with acne using isotretinoin: Protocol for a scoping review of clinical practice guidelines

[version 1; peer review: 1 approved]

Diarmuid Quinlan ^1,2, Laura Sahm³, Linda O'Keeffe^4-6, Miriam Santer⁷, Tony Foley¹

Diarmuid Quinlan ^1,2, Laura Sahm³, [...] Linda O'Keeffe^4-6, Miriam Santer⁷, Tony Foley¹

PUBLISHED 03 Jul 2024

Author details Author details

¹ Department of General Practice, School of Medicine, University College Cork, Cork, County Cork, Ireland
² Irish College of General Practitioners, 4/5 Lincoln Place, Dublin, Ireland
³ Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, County Cork, Ireland
⁴ School of Public Health, University College Cork, Cork, County Cork, Ireland
⁵ MRC integrative Epidemiology Unit, University of Bristol, Bristol, England, UK
⁶ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UK
⁷ Primary Care Research Centre, University of Southampton, Southampton, SO16 5ST, UK

Diarmuid Quinlan
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Laura Sahm
Roles: Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Linda O'Keeffe
Roles: Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Miriam Santer
Roles: Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Tony Foley
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Acne is the most common inflammatory skin disease, affecting most teenagers and many adults. Acne imposes physical, psychological, social and fiscal burdens, with additional concerns around antimicrobial stewardship.

Isotretinoin is the most effective treatment for severe acne. However, there are well-documented serious adverse effects with teratogenicity, impact on mental health and blood abnormalities of particular concern. The prescribing practice of isotretinoin varies substantially internationally. Some countries restrict isotretinoin prescribing solely to dermatologists, while other countries have guidance supporting GPs to prescribe isotretinoin as well.

The existing literature lacks clarity around the important issue of who should prescribe isotretinoin and fails to describe the specific role of GPs in managing patients with acne using isotretinoin. This scoping review will address this evidence gap by examining the role of the GP in prescribing isotretinoin in acne clinical practice guidelines.

Methods

This scoping review adopts the Joanna Briggs Institute scoping review methodology with PRISMA extension for scoping reviews. The search strategy will interrogate medical databases and grey literature, and will also directly contact key stakeholders internationally, to identify clinical practice guidelines on the use of isotretinoin in acne from 2013 to May 2024. Two reviewers will independently review all citations, and full text of selected sources, against relevant inclusion-exclusion criteria. Appropriate data extraction tool(s) will be designed, piloted and refined, whereupon full data extraction will be undertaken.

Results

This scoping review will interrogate diverse evidence sources and distil the evidence base informing the role of GPs in prescribing isotretinoin for people with acne.

Conclusion

The strategic objective of this scoping review is to explore and illuminate the evidence around the role of GPs in prescribing isotretinoin when managing patients with acne.

Keywords

Acne, Clinical Practice Guideline, Isotretinoin, General Practice

Corresponding author: Diarmuid Quinlan

Competing interests: No competing interests were disclosed.

Grant information: This research is supported by a research award from the Irish College of GPs and the HSE
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Quinlan D et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Quinlan D, Sahm L, O'Keeffe L et al. The role of general practitioners in the management of patients with acne using isotretinoin: Protocol for a scoping review of clinical practice guidelines [version 1; peer review: 1 approved]. HRB Open Res 2024, 7:45 (https://doi.org/10.12688/hrbopenres.13914.1) First published: 03 Jul 2024, 7:45 (https://doi.org/10.12688/hrbopenres.13914.1) Latest published: 03 Jul 2024, 7:45 (https://doi.org/10.12688/hrbopenres.13914.1)

Introduction

Acne vulgaris (hereafter acne) is the most common inflammatory dermatosis worldwide, at some point affecting approximately 85% of teenagers^1,2. Acne imposes substantial enduring physical, psychological and social sequelae, with a high personal burden of disease^2,3. Acne also inflicts a heavy burden on healthcare systems, especially clinician time^3,4. The extensive and prolonged use of antibiotics in managing acne raises concerns around antimicrobial stewardship^1–3,5,6.

Acne grading systems broadly classify acne severity based on the presence of acne lesions and global assessment^2,7. However, the severity of acne is difficult to reliably grade, lacking universally agreed and validated acne core outcome measures^8–10. Topical treatments and oral antibiotics are of limited efficacy for patients with moderate to-severe acne^2,9. Isotretinoin is the sole acne therapy to impact all the major aetiological pathways in acne^11,12. Isotretinoin is the most clinically effective therapy for severe acne and is the preferred first-line treatment for people with severe acne^2,11.

Whilst highly effective for the management of acne, isotretinoin carries an extensive and well-documented adverse effect profile, with impact on mental health, teratogenicity and blood abnormalities of particular concern^2,3,13. Current clinical guidelines recommend that clinicians monitor patients’ mental health, and undertake appropriate pregnancy and blood testing^2,14–18.

Recently, the Medicines and Healthcare products Regulatory Agency (MHRA) in Britain issued new guidance for dermatologists managing patients with acne with isotretinoin¹⁹. Concerns have been raised by dermatologists and by the British Association of Dermatology (BAD) that these additional prescribing precautions will lengthen consultation times, thereby increasing dermatologists’ workload, lengthening waiting times to see a dermatologist and ultimately negatively impacting patients’ timely access to isotretinoin²⁰.

There has been considerable debate around which clinician, i.e. General Practitioner (GP) or dermatologist should prescribe isotretinoin²¹. A recent systematic review found that national guidelines differ in recommendations on which clinician should prescribe isotretinoin, thereby negatively impacting timely and equitable patient access to treatment⁶. Current acne management guidelines recommend clinicians prescribing isotretinoin should screen for depression, advise on contraceptive care and undertake blood testing^2,22,23. GPs have argued they are well positioned to prescribe and manage isotretinoin^24,25.

The prescribing of isotretinoin in general practice varies internationally. Vocationally registered GPs in New Zealand have prescribed isotretinoin since 2009²⁶. Similarly, GPs in the Netherlands have guidance on prescribing isotretinoin for acne²⁷. In Ireland, the general practice acne management guidelines are silent on who should prescribe isotretinoin. Despite this silence, a significant minority (17%) of GPs in Ireland currently initiate isotretinoin²⁵. Furthermore, over 90% of Irish GPs who don’t initiate isotretinoin considered that isotretinoin could be safely prescribed in primary care²⁵. Current acne management guidelines in the UK recommend that isotretinoin is prescribed solely by dermatologists and doctors under their governance²⁸. GPs in the United Kingdom cannot independently prescribe isotretinoin²⁹. This restriction aligns with acne guidelines from Singapore and Norway⁶.

Clinical practice guidelines (CPGs) are systematically developed statements to assist healthcare professionals in evidence-informed decision making that is intended to optimize patient care³⁰. A recent systematic review of acne CPGs found that some acne guidelines are silent on which specialist, GP or dermatologist, may prescribe isotretinoin⁶. The role of the GP in managing these patients remains opaque, a deficit which this scoping review will address.

Therefore, much of the existing literature lacks clarity around the important issue of who should prescribe isotretinoin and fails to describe the specific role of GPs in managing patients with acne using isotretinoin. This scoping review will seek to address this issue, helping to bridge this clinically important evidence gap.

Aim and objectives

This scoping review aims to explore the recommended role of GPs in the management of patients with acne using isotretinoin in CPGs. The objectives are to identify, map and establish the evidence base underpinning the GP role.

In the management of patients with acne using isotretinoin, the scoping review seeks to answer the following questions:

1. What are the acne CPG recommendations regarding which clinician can prescribe isotretinoin
2. Specifically, what prescribing role is recommended for GPs regarding the initiation and ongoing prescription of isotretinoin
3. What are the recommendations for clinical assessment, investigation, monitoring and follow-up for GPs who initiate isotretinoin

Purpose: The review's purpose is to cohere evidence from the perspectives of clinical practice guidelines, professional bodies and key informants on the GP role in managing acne using isotretinoin.

Methods

This scoping review will adopt the Joanna Briggs Institute (JBI) scoping review methodology³¹. This scoping review will follow the PRISMA extension for Scoping Reviews (PRISMA-ScR) guideline and checklist³¹. This scoping review protocol was registered with Open Science Framework on 20.05.2024 (DOI 10.17605/OSF.IO/YD42V³².

Population: This scoping review will include CPGs that consider the management of acne vulgaris using oral isotretinoin. The initial search will identify acne management guidelines. The search will then be refined. This review will focus on acne CPGs to identify the role of the GP in prescribing isotretinoin for patients with acne.

Concept: This scoping review protocol is designed to explore the nature, content, extent, and limitations of CPGs for GPs prescribing isotretinoin to manage patients with acne. The sources of evidence will be professional clinical practice guidance and guidelines, identified via academic database searches, via key informant surveys, and grey literature searches.

Context: GPs manage people with acne of varying severity. There is varied guidance for GPs managing patients with acne using isotretinoin. This heterogeneity raises challenges for patients, dermatologists and GPs. There are important patient safety and quality of care implications for patients with acne seeking timely, equitable access to isotretinoin.

Search strategy

This scoping search strategy was developed by the authors (TF, LS, LMO’K, MS, DQ) in consultation with and guided by a university medical librarian (VC). Sources will include databases and grey literature for CPGs on the use of isotretinoin for all people with acne vulgaris. There will be no restriction of language. The literature search will be limited to publications from January 2013 to April 2024. These timelines were selected to reflect the evolution of clinical practice and to include the search timeline of a key prior publication³³.

We will include CPGs addressing the use of isotretinoin for people with acne. We will exclude research studies, conference proceedings, editorials, letters and local amendments to guidelines. We will directly contact key informants, following the strategy outlined below. This protocol will adopt the three-step search protocol outlined below, following the JBI guidelines and the PRISMA ScR checklist³⁴.

Step one: The initial scoping search, which is already completed and presented in Table 1, was restricted to PubMed and Embase. Titles and abstracts were searched with the following two keywords and synonyms: (a)acne (b) guideline OR guidance OR “best practice” OR algorithm OR recommend*

Table 1. Eligibility criteria.

Inclusion criteria	Exclusion criteria
All CPGs where oral isotretinoin is used in the management of acne vulgaris, and published between Jan 2013–May 2024 (most recent CPG version) No language restrictions CPG developed by international or national groups adhering to rigorous transparent academic procedures to develop CPGs, including scoping or systematic reviews.	CPG without mention of oral isotretinoin for the management of acne vulgaris CPG lacking rigorous, transparent development procedures or not using scoping or systematic reviews e.g. consensus statements Research studies, case reports, conference proceedings, editorials, opinion pieces, policy documents, letters and local amendments to guidelines CPG published prior to 2013

Step two: The two identified key words and synonyms: (a) acne AND (b) guideline will be used to search the following databases: PubMed, Embase, Scopus, Web of Science, PsycINFO and CINAHL. The guideline repositories that will be searched include DynaMed, Scottish Intercollegiate Guidelines Network, Guidelines International Network and TRIP database. Grey literature sources to be searched are Google Scholar (first 100 citations), regulatory recommendations and clinical guidelines and professional guidance. (Table 2)

Table 2. Search strategy: PubMed and Embase.

Search undertaken on 20.5.24.

Search	Search Terms	PubMed Title & Abstract Records retrieved 2013–May 2024	Embase Title & Abstract Records retrieved 2013–May 2024
#1	acne	9,523	15,118
#2	guideline OR algorithm OR recommend* Or guidance Or “best practice”	874,007	1,640,267
#3	#1 and #2	760	1,538

Step three: The reference lists of all relevant evidence sources including academic papers will be hand-searched, snowballing to identify potentially relevant additional material.

Contacting key informants: The authors will engage their professional clinical networks to contact key stakeholders, both nationally and internationally, to identify additional relevant material. One author (DQ) is a member of the European Society for Quality and Safety in Family Practice (EQuiP)³⁵. We will seek guidance for GPs managing acne using isotretinoin from the twenty member countries of EQuiP and from (i) the USA, (ii) Canada, (iii) UK, (iv) Australia and (v) New Zealand. The professional network of the authors includes key stakeholders in these countries. We can leverage the professional network of these stakeholders to extend our search to further countries where necessary.

Notwithstanding this broad scoping search strategy, it is likely that some information sources may be omitted.

Studies published in all languages will be included. Google translate will be used to translate any articles not written in English. Relevant studies which are not written in English, and which satisfy the inclusion criteria will, where feasible, have the full text professionally translated.

Screening and selection of evidence sources

All citations identified by the JBI three stage search which meet the protocol inclusion criteria will be uploaded to Covidence and duplicates deleted.

Two reviewers (TF and DQ) will pilot the review process. They will independently review 10% of randomly selected abstracts against the inclusion criteria to achieve agreement of 75% or above. Once this alignment is achieved, both reviewers will independently review the full suite of selected abstracts, to identify potentially relevant literature³¹. The full-text document of these selected sources will then be independently reviewed by these two reviewers to identify material consistent with the inclusion criteria. The rationale for excluding any full-text document will be reported in an addendum to the scoping review. Any disparities between reviewers will be resolved by discussion to achieve consensus, with a third reviewer (LS or LO’K) adjudicating where necessary.

The entire selection process will be mapped and reported with graphical display, aligning with the adapted chart of the PRISMA-ScR³⁶. Given the diverse evidence sources, potentially relevant evidence may emerge during searching, screening or selection: the search may be amended during the review process³¹. Search amendments will be updated in the scoping review protocol.

Data extraction

The extracted data will focus on literature addressing the use of isotretinoin for all people with acne. Given the diverse evidence sources, we will develop one or more data extraction tools to capture relevant evidence. The key data extracted will include clinical practice guidance about which clinician may prescribe isotretinoin, the GP prescribing role and the recommended clinical assessment, investigation, prescribing guidance, monitoring, follow-up and overall management of patients in whom the GP initiates isotretinoin.

A draft data extraction form will be developed and included, modelled on the JBI data extraction tool³⁴. The draft tool will be independently piloted on each evidence source by two reviewers (TF and DQ), followed by consultation and refinement of the data extraction tool³⁷. Given the varied evidence sources, it is anticipated that further modification of the data extraction tool may occur on an iterative basis. All modifications will be fully reported in the scoping review. These same two reviewers (TF and DQ) will then independently extract the required data. Disparities between reviewers will be resolved as previously described. Should additional study data be required, one reviewer (DQ) will contact the study authors.

Data analysis and presentation

Data analysis and presentation is an iterative process with any deviations from protocol clearly identified in the scoping review. This scoping review encompasses diverse evidence sources and will present a narrative synthesis, with tabulated/charted synopsis of the evidence. This will align with the strategic objective of this research, to illustrate the evidence base underlying and informing the use of isotretinoin in the management of acne in general practice. These key findings may identify strategic evidence gaps in clinical practice guidance for GPs managing acne with isotretinoin. Such evidence gaps may have important implications for clinicians, patient safety, and quality of clinical care.

Dissemination of information

This research will be shared by publication in a clinical academic peer reviewed journal. We anticipate presenting the research at both national and international clinical conferences. We will engage with professional bodies such as the Irish College of General Practitioners, EQuiP, Pharmaceutical Society of Ireland, and clinical dermatology societies to accelerate the translation of research into clinical practice.

Data availability

No data are associated with this article

Acknowledgments

We gratefully acknowledge the expert contribution of Virginia Conrick, medical librarian, University College Cork, Cork for her expertise in developing and refining the search strategy.

Faculty Opinions recommended

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Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 03 Jul 2024

Author details Author details

¹ Department of General Practice, School of Medicine, University College Cork, Cork, County Cork, Ireland
² Irish College of General Practitioners, 4/5 Lincoln Place, Dublin, Ireland
³ Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, County Cork, Ireland
⁴ School of Public Health, University College Cork, Cork, County Cork, Ireland
⁵ MRC integrative Epidemiology Unit, University of Bristol, Bristol, England, UK
⁶ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UK
⁷ Primary Care Research Centre, University of Southampton, Southampton, SO16 5ST, UK

Diarmuid Quinlan
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Laura Sahm
Roles: Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Linda O'Keeffe
Roles: Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Miriam Santer
Roles: Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Tony Foley
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This research is supported by a research award from the Irish College of GPs and the HSE
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (1)

version 1

Published: 03 Jul 2024, 7:45

https://doi.org/10.12688/hrbopenres.13914.1

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© 2024 Quinlan D et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Quinlan D, Sahm L, O'Keeffe L et al. The role of general practitioners in the management of patients with acne using isotretinoin: Protocol for a scoping review of clinical practice guidelines [version 1; peer review: 1 approved]. HRB Open Res 2024, 7:45 (https://doi.org/10.12688/hrbopenres.13914.1)

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Open Peer Review

Version 1

VERSION 1

PUBLISHED 03 Jul 2024

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Reviewer Report 31 Jul 2024

Caroline Mc Carthy, Royal College of Surgeons in Ireland, Dublin, Leinster, Ireland

Approved

https://doi.org/10.21956/hrbopenres.15262.r41639

Overall feedback:
The protocol is clearly written and justified. The overall aim is to explore the recommended role of GPs in the management of patients with acne using isotretinoin in clinical practice guidelines (CPGs).

Specific feedback:
... Continue reading

Overall feedback:
The protocol is clearly written and justified. The overall aim is to explore the recommended role of GPs in the management of patients with acne using isotretinoin in clinical practice guidelines (CPGs).

Specific feedback:
Title: The title clearly indicates this is a scoping review and reflects the main research question around the use of isotretinoin by GPs.
Abstract: The abstract succinctly summarizes the aim, methods, and significance of the scoping review.
Introduction: The introduction is well written with a clear rationale for the project. Objectives are clearly stated.
Methods: Overall clear and well written. Some minor points:

Table 1 is not correctly referenced in the text (the reference is to the search strategy), but Table 1 lists inclusion and exclusion criteria.
For the three-step process, please outline the aim of each step (e.g., step 1 is a limited initial search). Were the search terms modified based on this process?
Table 2 looks as though it should be referenced in step 1.
Is the full search strategy complete? If so, consider adding it as an appendix.
Contacting key informants is part of step 3 (reviewing references and additional sources). Consider including details on how the contact with stakeholders will be documented and how the identified materials will be evaluated for inclusion.

Your description of the review process is generally clear, but a few areas could benefit from additional detail to enhance transparency and understanding. The phrase "which meet the protocol inclusion criteria" suggests that an initial screening will take place before uploading citations to Covidence. To avoid confusion, it would be clearer to state, "All identified records will be uploaded to Covidence and duplicates deleted." This ensures it is understood that the initial screening for inclusion criteria will occur within Covidence. Additionally, specifying the method or software used to randomly select the 10% of abstracts for the pilot review would enhance clarity. Clarifying which tools will be used for the initial title and abstract screening would ensure readers understand how the review process is managed. These clarifications will help to ensure the review process is clearly communicated and replicable.
The data extraction process is overall clear, and I accept that this will be an iterative process. It might help the reader if you provide some examples of key areas that will be extracted. Will you use Covidence for this? Although not always necessary for scoping reviews, will you use any methods for appraising the quality of included studies? For example, Appraisal of guidelines for research and evaluation (AGREE) II instrument (https://www.agreetrust.org/wp-content/uploads/2013/10/AGREE-II-Users-Manual-and-23-item-Instrument_2009_UPDATE_2013.pdf). Another option for CPGs is the the MiChe Checklist (1, 2), which consists of eight specific questions (recommendations, audience, objectives, conflict of interest, systematic search, unambiguity, evaluation of benefits, and update) and two holistic items (overall assessment and recommendation for further use). Additionally, it would be important to document the evidence grading system used by each CPG and whether the CPG includes a conflict of interest (COI) statement.
Your description of the data analysis and presentation process is clear and aligns well with the objectives of your scoping review. However, to enhance clarity and comprehensiveness, it would be beneficial to outline your initial plan for data analysis in more detail. For instance, will you quantify certain outcomes such as the number of clinical practice guidelines (CPGs) that specifically highlight the role of the GP in the management of acne, or how many CPGs have clearly defined follow-up periods and assessments of adequate response to treatment? Additionally, you should specify whether you will perform a thematic analysis of the broad areas or concepts covered by the CPGs, and if so, whether this will be an inductive approach or if you will use a top-down framework. Providing this level of detail in your analysis plan will strengthen the rigour of your protocol. Once this plan is clearly outlined, you can then add how deviations from the protocol will be identified and specified, ensuring that any changes are documented with a rationale and potential impact on the findings.
I think a discussion to pull your protocol together might be nice. You could briefly summarize the strengths of this work (comprehensive search including all languages, title and abstract and full-text screening done in duplicate, data extraction done in duplicate) and highlight the potential implications. Will this group develop a set of recommendations for GPs managing acne vulgaris with isotretinoin?
1. (Semlitsch et al.,2014)(Ref-1)
2. (Siebenhofer et al.,2016)(Ref-2)

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?

Not applicable

References

1. Semlitsch T, Jeitler K, Kopp IB, Siebenhofer A: [Development of a workable mini checklist to assess guideline quality].Z Evid Fortbild Qual Gesundhwes. 2014; 108 (5-6): 299-312 PubMed Abstract | Publisher Full Text
2. Siebenhofer A, Semlitsch T, Herborn T, Siering U, et al.: Validation and reliability of a guideline appraisal mini-checklist for daily practice use.BMC Med Res Methodol. 2016; 16: 39 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: I am an academic GP with a primary focus on medicine safety in primary care. I have methodological expertise in the conduct and analysis of clinical trials in primary care settings. Additionally, I have significant experience in pharmaco-epidemiological research. My experience with evidence synthesis includes recently completing a systematic review (SR) of clinical practice guidelines (CPG) for the management of chronic non-cancer pain in primary care and another SR evaluating the effectiveness of interactive dashboards to optimise prescribing in primary care. While I do not have extensive academic expertise in the topic area of isotretinoin and dermatology, I do have some clinical expertise as a practicing GP and methodological expertise with respect to conducting a comprehensive scoping review on the role of GPs in managing acne with isotretinoin.

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.

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Caroline Mc Carthy, Royal College of Surgeons in Ireland, Dublin, Ireland

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Reviewer Report

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31 Jul 2024 | for Version 1

Caroline Mc Carthy, Royal College of Surgeons in Ireland, Dublin, Leinster, Ireland

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Approved

Overall feedback:
The protocol is clearly written and justified. The overall aim is to explore the recommended role of GPs in the management of patients with acne using isotretinoin in clinical practice guidelines (CPGs).

Specific feedback:
Title: The title clearly indicates this is a scoping review and reflects the main research question around the use of isotretinoin by GPs.
Abstract: The abstract succinctly summarizes the aim, methods, and significance of the scoping review.
Introduction: The introduction is well written with a clear rationale for the project. Objectives are clearly stated.
Methods: Overall clear and well written. Some minor points:

Table 1 is not correctly referenced in the text (the reference is to the search strategy), but Table 1 lists inclusion and exclusion criteria.
For the three-step process, please outline the aim of each step (e.g., step 1 is a limited initial search). Were the search terms modified based on this process?
Table 2 looks as though it should be referenced in step 1.
Is the full search strategy complete? If so, consider adding it as an appendix.
Contacting key informants is part of step 3 (reviewing references and additional sources). Consider including details on how the contact with stakeholders will be documented and how the identified materials will be evaluated for inclusion.

Your description of the review process is generally clear, but a few areas could benefit from additional detail to enhance transparency and understanding. The phrase "which meet the protocol inclusion criteria" suggests that an initial screening will take place before uploading citations to Covidence. To avoid confusion, it would be clearer to state, "All identified records will be uploaded to Covidence and duplicates deleted." This ensures it is understood that the initial screening for inclusion criteria will occur within Covidence. Additionally, specifying the method or software used to randomly select the 10% of abstracts for the pilot review would enhance clarity. Clarifying which tools will be used for the initial title and abstract screening would ensure readers understand how the review process is managed. These clarifications will help to ensure the review process is clearly communicated and replicable.
The data extraction process is overall clear, and I accept that this will be an iterative process. It might help the reader if you provide some examples of key areas that will be extracted. Will you use Covidence for this? Although not always necessary for scoping reviews, will you use any methods for appraising the quality of included studies? For example, Appraisal of guidelines for research and evaluation (AGREE) II instrument (https://www.agreetrust.org/wp-content/uploads/2013/10/AGREE-II-Users-Manual-and-23-item-Instrument_2009_UPDATE_2013.pdf). Another option for CPGs is the the MiChe Checklist (1, 2), which consists of eight specific questions (recommendations, audience, objectives, conflict of interest, systematic search, unambiguity, evaluation of benefits, and update) and two holistic items (overall assessment and recommendation for further use). Additionally, it would be important to document the evidence grading system used by each CPG and whether the CPG includes a conflict of interest (COI) statement.
Your description of the data analysis and presentation process is clear and aligns well with the objectives of your scoping review. However, to enhance clarity and comprehensiveness, it would be beneficial to outline your initial plan for data analysis in more detail. For instance, will you quantify certain outcomes such as the number of clinical practice guidelines (CPGs) that specifically highlight the role of the GP in the management of acne, or how many CPGs have clearly defined follow-up periods and assessments of adequate response to treatment? Additionally, you should specify whether you will perform a thematic analysis of the broad areas or concepts covered by the CPGs, and if so, whether this will be an inductive approach or if you will use a top-down framework. Providing this level of detail in your analysis plan will strengthen the rigour of your protocol. Once this plan is clearly outlined, you can then add how deviations from the protocol will be identified and specified, ensuring that any changes are documented with a rationale and potential impact on the findings.
I think a discussion to pull your protocol together might be nice. You could briefly summarize the strengths of this work (comprehensive search including all languages, title and abstract and full-text screening done in duplicate, data extraction done in duplicate) and highlight the potential implications. Will this group develop a set of recommendations for GPs managing acne vulgaris with isotretinoin?
1. (Semlitsch et al.,2014)(Ref-1)
2. (Siebenhofer et al.,2016)(Ref-2)

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?

Not applicable

References

1. Semlitsch T, Jeitler K, Kopp IB, Siebenhofer A: [Development of a workable mini checklist to assess guideline quality].Z Evid Fortbild Qual Gesundhwes. 2014; 108 (5-6): 299-312 PubMed Abstract | Publisher Full Text
2. Siebenhofer A, Semlitsch T, Herborn T, Siering U, et al.: Validation and reliability of a guideline appraisal mini-checklist for daily practice use.BMC Med Res Methodol. 2016; 16: 39 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

I am an academic GP with a primary focus on medicine safety in primary care. I have methodological expertise in the conduct and analysis of clinical trials in primary care settings. Additionally, I have significant experience in pharmaco-epidemiological research. My experience with evidence synthesis includes recently completing a systematic review (SR) of clinical practice guidelines (CPG) for the management of chronic non-cancer pain in primary care and another SR evaluating the effectiveness of interactive dashboards to optimise prescribing in primary care. While I do not have extensive academic expertise in the topic area of isotretinoin and dermatology, I do have some clinical expertise as a practicing GP and methodological expertise with respect to conducting a comprehensive scoping review on the role of GPs in managing acne with isotretinoin.

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.

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The role of general practitioners in the management of patients with acne using isotretinoin: Protocol for a scoping review of clinical practice guidelines

Abstract

Background

Methods

Results

Conclusion

Keywords

Introduction

Aim and objectives

Methods

Search strategy

Table 1. Eligibility criteria.

Table 2. Search strategy: PubMed and Embase.

Screening and selection of evidence sources

Data extraction

Data analysis and presentation

Dissemination of information

Data availability

Acknowledgments

References

Comments on this article Comments (0)

Open Peer Review

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Reviewer Reports

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Are you a HRB-funded researcher?

Thank you!

The role of general practitioners in the management of patients with acne using isotretinoin: Protocol for a scoping review of clinical practice guidelines

Abstract

Background

Methods

Results

Conclusion

Keywords

Introduction

Aim and objectives

Methods

Search strategy

Table 1. Eligibility criteria.

Table 2. Search strategy: PubMed and Embase.

Screening and selection of evidence sources

Data extraction

Data analysis and presentation

Dissemination of information

Data availability

Acknowledgments

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

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Are you a HRB-funded researcher?

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