The use of small group based educational interventions in General Practice to improve antibiotic prescribing behaviours: a mixed methods systematic review protocol

Kevin F Roche; Anthony Maher; Eimear C Morrissey; Rosie Dunne; Andrew W Murphy; Gerard J Molloy

doi:10.12688/hrbopenres.13878.2

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Study Protocol

Revised

The use of small group based educational interventions in General Practice to improve antibiotic prescribing behaviours: a mixed methods systematic review protocol

[version 2; peer review: 1 approved, 1 approved with reservations]

Kevin F Roche ¹, Anthony Maher¹, Eimear C Morrissey^2,3, Rosie Dunne⁴, Andrew W Murphy^5,6, Gerard J Molloy¹

Kevin F Roche ¹, Anthony Maher¹, [...] Eimear C Morrissey^2,3, Rosie Dunne⁴, Andrew W Murphy^5,6, Gerard J Molloy¹

PUBLISHED 06 Dec 2024

Author details Author details

¹ School of Psychology, University of Galway, Galway, County Galway, Ireland
² Centre for Health Research Methodology, School of Nursing and Midwifery, University of Galway, Galway, County Galway, Ireland
³ Institute for Clinical Trials, College of Medicine, Nursing and Health Sciences, University of Galway, Galway, County Galway, Ireland
⁴ Library, University of Galway, Galway, County Galway, Ireland
⁵ Department of General Practice, College of Medicine, Nursing and Health Sciences, University of Galway, Galway, County Galway, Ireland
⁶ HRB Primary Care Clinical Trials Network, University of Galway, Galway, Ireland

Kevin F Roche
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Anthony Maher
Roles: Writing – Review & Editing

Eimear C Morrissey
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Rosie Dunne
Roles: Data Curation, Methodology, Supervision, Validation, Writing – Review & Editing

Andrew W Murphy
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Gerard J Molloy
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Inappropriate use of antimicrobial agents in healthcare settings is one area that has received attention as a possible route to mitigate the threat of antimicrobial resistance. Globally, the highest consumption of antimicrobials in human healthcare originates from antibiotic prescriptions in Primary Care. Strategies to increase appropriate antibiotic prescribing, which can mean not prescribing an antibiotic e.g. cases of viral infection, have been developed and evaluated. This systematic review aims to synthesise the literature of studies of small group based in person educational interventions designed to increase appropriate antibiotic prescribing behaviours in General Practice settings.

Methods

EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, MEDLINE and PsycINFO will be systematically searched from inception until May 2024 for primary studies of small group based educational interventions designed to improve the antimicrobial prescribing behaviours in General Practice. Qualitative, quantitative and mixed methods studies reporting on the phenomenon of interest will be included. All identified articles will be double screened at title and abstract level. One reviewer will then screen all included studies at full text level, extract the data, code the intervention and perform risk of bias assessment with other reviewers performing verification of a randomly selected 20% of the articles. We will use an integrated approach to mixed method systematic reviews and will perform a narrative, or if possible quantitative, synthesis.

Discussion

The review will identify and assess the efficacy and / or effectiveness of small group based educational interventions designed to improve the antibiotic prescribing behaviours of General Practitioners. By using a mixed methods approach we aim to identify the salient content of the included interventions and the perspectives of participants on the content and delivery of the included interventions. We will use the findings to inform the design and content of a small group educational intervention for GP registrars.

Keywords

General Practice, Antibiotics, Education, Interventions, Continuing Professional Development,

Corresponding author: Kevin F Roche

Competing interests: No competing interests were disclosed.

Grant information: This work was supported by the Irish Research Council [GOIPG/2022/444].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Roche KF 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: Roche KF, Maher A, Morrissey EC et al. The use of small group based educational interventions in General Practice to improve antibiotic prescribing behaviours: a mixed methods systematic review protocol [version 2; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2024, 7:29 (https://doi.org/10.12688/hrbopenres.13878.2) First published: 20 May 2024, 7:29 (https://doi.org/10.12688/hrbopenres.13878.1) Latest published: 06 Dec 2024, 7:29 (https://doi.org/10.12688/hrbopenres.13878.2)

Revised Amendments from Version 1

We would like to thank the reviewers for taking the time to review our protocol and for the constructive and beneficial feedback that they provided on the previous version. Taking the suggestions that were given by the reviewers we have made some minor changes to the manuscript that are addressed point by point in the responses section. Taking into account the feedback and suggestions from the reviewers the changes we have made to the updated version are:
Title
We now specify in the title the the focus of the review is the use of small group based educational interventions in General Practice to improve antibiotic prescribing behaviours: a mixed methods systematic review protocol
Introduction
We have provided an additional paragraph outlining our justification for the focus of the review.
Data Synthesis
We have clarified the data synthesis section.
Study status
We have updated the study staus
Discussion
In the discussion section we have added a section expanding on our justification for the focus of the review while also acknowledging that in many countries outside Ireland other healthcare profession can prescribe antibiotics.

See the authors' detailed response to the review by Nathaly Garzón-Orjuela
See the authors' detailed response to the review by Derek Stewart

Introduction

Antimicrobial resistance (AMR) refers to the process where microorganisms become resistant to antimicrobial drugs, making once treatable infections challenging or impossible to manage¹. The impact of AMR extends beyond treatment of infectious diseases. For example, the use of antimicrobial agents prophylactically in routine surgical procedures may be less effective, increasing the risk of serious infection. There are two identified strategies for addressing AMR, the first is the development of new antimicrobial agents and the second is tackling the inappropriate use of current antimicrobial agents.

As there is currently limited development of new antimicrobial agents¹, current research and practice development requires a considerable focus on addressing the appropriate use of existing antimicrobials in a variety of settings. As AMR has increasingly become a global health concern² the overconsumption, and inappropriate consumption, of antimicrobials, in particular antibiotics, has been identified as a key factor in the advance of AMR internationally³. Focusing on the consumption of antimicrobials is a key recognised element in addressing the threat of AMR¹ and one element that has been highlighted as particularly relevant in human health is the antimicrobial prescribing behaviours of healthcare professionals⁴.

Appropriate prescribing of antimicrobials refers to using these agents only when indicated and then using the right drug at the right dose for the right length of time. While antimicrobial resistance encompasses numerous types of microorganisms including viruses, fungi and bacteria, the AMR focus of this review will be on the increasing bacterial resistance arising from the overuse of antibiotics, often through inappropriate prescribing⁵, in human health settings⁶ as the majority of human antibiotic consumption in Ireland and globally originates in Primary Care settings^6,7. Inappropriate prescribing of antibiotics refers to when antibiotics are prescribed for conditions where there is no evidence that the antibiotics would provide any benefit⁸ as well as when then the prescribed agent is not optimal e.g. the prescribing of broad spectrum antibiotics when narrow spectrum antibiotics are indicated or when the duration of the prescribed treatment course is incorrect. Despite the increase in the promotion of appropriate antibiotic prescribing behaviours in General Practice⁹ inappropriate prescribing still occurs due to a number of different factors¹⁰ and General Practitioners (GPs’) antibiotic prescribing practices, once established, tend to remain consistent¹¹. As the focus of this review is on interventions targeting GPs we are referring to the settings as General Practice as opposed to Primary Care which could also potentially include non – GP prescribers such as Nurses and Pharmacists. We will include Primary Care studies if they report exclusively or provide separate data on GPs. We are focusing this review on Small Group learning as this format has been successfully used to integrate updated clinical knowledge with regular patient care in General Practice settings¹². It has also been used to address issues where GPs experience clinical uncertainty in their daily practice¹³. In the prescribing of antibiotics GPs can experience this type of uncertainty for example; when parents present a child and offer a candidate diagnosis of the child's condition seemingly advocating for antibiotics¹⁴. The benefit of using the format of small group learning is that is affords members the psychological safety to express uncertainty that allows for collaborative learning¹⁵. As uncertainty has been identified as a component in the inappropriate prescribing of antibiotics by Primary Care physicians¹⁶ identifying the components as well as other relevant data for these types of interventions is important.

Therefore, the present review aims to systematically evaluate and synthesise all the relevant available evidence on the efficacy and potential effectiveness of small group based educational interventions delivered to GPs that aim to improve antimicrobial prescribing behaviours. Small group learning in general practice has a long and key role in post graduate and continuing general practice education. Focusing this systematic review on small group based learning in General Practice provides an unique opportunity to inform future interventions designed to address and improve inappropriate antibiotic prescribing behaviours. By synthesising quantitative, qualitative and mixed methods studies we aim to provide a comprehensive understanding of the role that these types of interventions can play in addressing the inappropriate prescribing of antibiotics in General Practice. To our knowledge, this is the first systematic review of this kind that focuses exclusively on small group based educational interventions designed to improve antibiotic prescribing behaviours specifically in General Practice.

Objectives

The objectives of this mixed methods systematic review are to review and synthesise the literature of small group based in person educational interventions designed to improve antibiotic prescribing behaviours in General Practice and to assess their efficacy and potential effectiveness, to identify the components of these interventions and to identify the insights, such as content, including barriers and facilitators, of intervention delivery from the participants and intervention providers.

Methods

This protocol has been reported using the PRISMA – P (Preferred Reporting Items for Systematic Reviews and Meta – Analysis Protocols) guidelines¹⁷. The final systematic review will follow the PRISMA guidelines¹⁸.

Design

This review will follow a mixed methods systematic review methodology¹⁹ using the integrated approach²⁰ that will allow for the synthesising of the quantitative and qualitative data into a single synthesis.

Stakeholder involvement

Involving stakeholders in reviews has been identified as a possible method through which the impact of reviews can be increased²¹. Following the ACTIVE framework for stakeholder involvement in systematic reviews²² two relevant stakeholders, one GP registrar and one educational co-director of a GP training programme will join the existing review team, of whom one is an established GP and another a pharmacist, and will contribute to the review. The ACTIVE framework describes 5 levels of stakeholder involvement in reviews, leading, controlling, influencing, contributing and receiving²². The participating stakeholder’s participation in this review will be at the controlling, influencing and contributing levels. Stakeholders will be involved in screening, data extraction, assessment of risk of bias, preparing the review data for publication and final write up for publication and dissemination and will be acknowledged in all dissemination activities.

Eligibility

Phenomenon of interest. The phenomenon of interest is the use of in person small group based educational interventions to improve antibiotic prescribing among General Practitioners. Our definition of small group based educational interventions is reflective of the definition provided by Crosby (1996)²³ where the characteristics of the small group meeting as opposed to the number of participants is the most important aspect. The three characteristics outlined are that there must be active participation, there must be work toward a specific task (in our case it will be to improve antibiotic prescribing behaviours) and reflection²³.

Types of studies

Primary studies that report on the phenomenon of interest will be included regardless of whether they use quantitative, qualitative or mixed – methods approaches. Table 1 outlines the inclusion and exclusion criteria.

Table 1. Inclusion / exclusion criteria.

Inclusion criteria	Exclusion criteria
Type of studies
• Quantitative, qualitative or mixed – methods studies • Publications available in English language • No restriction on publication date	• Conference abstracts, editorials, protocols • Systematic reviews / meta - analyses
Participants
• GPs or GP Registrars working in General Practice / Primary Care settings • Intervention facilitators	• GP Registrars working in secondary care • GPs not primarily working in General Practice settings • Studies where the data for GPs and non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings are not reported seperately • Studies reporting on interventions where the data from secondary care settings and primary care settings are not reported separately
Phenomenon of interest
• Studies that explore the use of in person small group based educational interventions to improve antibiotic prescribing among General Practitioners	• Studies that explore the use of asynchronous educational interventions (non-group based) • Studies that rely solely on online learning (non- in person based)

Population

We will include studies that focus on General Practitioners or GP Registrars (qualified doctors engaged in General Practice post graduate training) who primarily work in General Practice or Primary Care settings. We will include studies where the participation population is mixed with a) other Primary Care prescribers e.g. Nurses or Pharmacists or b) secondary care prescribers where the populations are reported separately, and it is possible to discern the data for the GP population.

Phenomenon of interest

Where studies examine the efficacy and effectiveness of small group based in person educational interventions to improve antibiotic prescribing behaviours, they will be included and we will report the findings. Where efficacy and/or effectiveness are not measured or for qualitative studies, we will report the intervention content and data from the participants.

Context

Given that the threat of antimicrobial resistance is a global threat we will consider studies from all geographical regions.

Sources

We will carry out a thorough database search of EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Ovid MEDLINE and Ovid PsycINFO. The timeframe of the search will be from database inception to May 2024. All included publications will be reference searched, forward and backward, to identify any other potentially relevant studies. Where data is missing or not reported in identified studies the corresponding study authors will be contacted where feasible. Relevant systematic reviews and meta- analyses will be screened for primary studies that were not identified in the initial searches.

Search strategy

An example of the search strategy for Ovid MEDLINE can be located at https://www.crd.york.ac.uk/PROSPEROFILES/512491_STRATEGY_20240516.pdf with each search being adapted for the relevant databases. All search strategies including the date of searching will be included in the final review. The final search strategy will be developed in conjunction with a specialist research librarian based in the University of Galway.

Data management

Database search results will be imported into Covidence. Any duplicates will be removed and will then be checked by a member of the review team. Articles will then be screened using the Covidence platform.

Study selection

All articles will be independently double screened at title and abstract level. The main reviewer (KR) will review 100% of articles with the double screening being divided up between members of the review team. The main reviewer (KR) will screen 100% of the articles at full text level and two reviewers will independently screen 10% (20% in total) of randomly selected articles. Disagreements at all levels will be resolved through discussion and will involve consultation with a third reviewer as required. Reasons for inclusion/exclusion will be recorded and reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)¹⁸ flow diagram in the final review.

Data extraction

The main reviewer (KR) will design a data extraction template and will be carried out using COVIDENCE software. The data extraction template will be piloted where two reviewers (KR & AMR) who will independently extract the relevant data from two of the included studies and a third reviewer (EM) will decide on the suitability of the data extraction form. The following data will be extracted:

Bibliographic data – author(s), affiliation of author(s), year of publication, source/journal and country
Study type – observational, qualitative, quantitative or mixed methods
Characteristics of the studies – study aim, study design, study population, and sample size
Characteristics of the interventions – type of intervention, method of delivery, duration, location, utility/feasibility of intervention and theoretical or conceptual framework used for intervention and quality of intervention reporting (based on the TIDieR checklist²⁴).
Findings – Outcomes assessed, results of interventions, facilitators and/or barriers of the intervention and participants and / or facilitators experiences/perspectives.

Where an intervention is reported across multiple publications, we will extract and combine the data. In the case of missing data, we will contact the corresponding authors where feasible. Due to the research constraints it is not possible for independent data extraction by two reviewers. The main reviewer will extract the data from 100% of the included studies while a second reviewer will check a random selection of 20% of included studies for accuracy.

Data extracted from quantitative studies will include data based outcomes reported regarding the use of small group based educational interventions administered to GPs / GP registrars to improve antibiotic prescribing behaviours. Qualitative data will be extracted and categorised by theme based on the the review objectives.

Data synthesis

This review will follow the JBI convergent integrated approach²⁵. The quantiatative data will be interpreted and transformed into qualitative data. This will allow for the transformed quantitative data and the qualitative data from qualitative and mixed methods studies to be integrated and reported via a narrative synthesis.

Risk of bias

The Mixed Methods Appraisal Tool²⁶ will be used to carry out the risk of bias assessment. The main reviewer (KR) will assess 100% of the included studies and a second reviewer will assess a random selection of 20% of included studies. The assessments will be compared, and any disagreements will be resolved through discussion and consensus or if necessary, a third author (EM).

Ethics

This systematic review will consist of reviewing and collating publicly available research materials and therefore does not require ethical approval.

This systematic review is the first study in a multi-phase research project that aims to improve antibiotic prescribing behaviours among GP registrars in Irish General Practice funded by the Irish Research Council. Ethical approval for the later stages of the project will be sought from the pertinent Research Ethics Committees. The findings from the systematic review will be combined with data accumulated from the later phases of the project.

Dissemination

Following completion of the systematic review the findings will be published in a peer reviewed open-source journal, presented at national and international conferences and the findings shared with relevant organisations. All review materials will be made freely available under the study review registration at https://osf.io/et2gx/

Study status

The study protocol has been registered on PROSPERO (CRD42024512491).

At the time of publication of this protocol (Version 2) the stakeholders have been recruited, the search strategies developed, searching carried out (July 2024) and title and abstract screening is underway.

Protocol tracking

Any amendments to this study protocol, including the dates of the amendments and the review team’s reasoning for the amendments will be recorded on the study site on the OSF platform (https://osf.io/et2gx/) and will be included in the final published systematic review.

Discussion

The primary outcome of interest is the efficacy, potential effectiveness and format (content and delivery) of small group based in person educational interventions designed to improve antibiotic prescribing behaviours of General Practitioners in Primary Care settings. We have opted to use a mixed methods systematic review approach as the operationalisation and reporting of these interventions can vary across regions due to differences in healthcare systems (i.e. public, private or mixed). Also, as the format of data collected can vary due to the different healthcare systems that studies were conducted in following a mixed methods approach will allow us to systematically review the greatest number of studies on the phenomenon of interest. Examples of the types of data we expect to find include quantitative data on prescribing rates, adherence to national or local guidelines or qualitative data on barriers and facilitators of adhering to guidelines, differences in prescribing due to patient type (public vs. private) or mixed methods studies including both quantitative and qualitative data. As the findings of this systematic review will be used to inform the content and design of a small group educational intervention for Irish General Practice registrars we have opted to only review the data specific to General Practitioners while recognising that in many countries clinicians other than medical doctors can prescribe antibiotics in Primary Care settings.

Data availability

No data are associated with this article.

Faculty Opinions recommended

References

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4. Papoutsi C, Mattick K, Pearson M, et al.: Social and professional influences on antimicrobial prescribing for doctors-in-training: a realist review. J Antimicrob Chemother. 2017; 72(9): 2418–30. PubMed Abstract | Publisher Full Text | Free Full Text
5. Avent ML, Cosgrove SE, Price-Haywood EG, et al.: Antimicrobial stewardship in the primary care setting: from dream to reality? BMC Fam Pract. 2020; 21(1): 134. PubMed Abstract | Publisher Full Text | Free Full Text
6. Goossens H, Ferech M, Stichele RV, et al.: Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005;365(9459): 579–87. PubMed Abstract | Publisher Full Text
7. O’Connor R, O’Doherty J, O’Regan A, et al.: Antibiotic use for Acute Respiratory Tract Infections (ARTI) in primary care; what factors affect prescribing and why is it important? A narrative review. Ir J Med Sci. 2018; 187(4): 969–86. PubMed Abstract | Publisher Full Text | Free Full Text
8. Bell BG, Schellevis F, Stobberingh E, et al.: A systematic review and meta-analysis of the effects of antibiotic consumption on antibiotic resistance. BMC Infect Dis. 2014; 14(1): 13. PubMed Abstract | Publisher Full Text | Free Full Text
9. Ireland’s second one health national action plan on antimicrobial resistance.pdf.
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13. Sommers LS, Launer J, eds.: Clinical uncertainty in primary care: the challenge of collaborative engagement. Springer New York; 2013. Publisher Full Text
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15. Marold J, Lassalle R, Schöbel M, et al.: Field observation of group decision-making.
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17. Shamseer L, Moher D, Clarke M, et al.: Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015; 350: g7647. PubMed Abstract | Publisher Full Text
18. Page MJ, McKenzie JE, Bossuyt PM, et al.: The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372: n71. PubMed Abstract | Publisher Full Text | Free Full Text
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Version 2

VERSION 2 PUBLISHED 20 May 2024

Author details Author details

Anthony Maher
Roles: Writing – Review & Editing

Eimear C Morrissey
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Rosie Dunne
Roles: Data Curation, Methodology, Supervision, Validation, Writing – Review & Editing

Andrew W Murphy
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Gerard J Molloy
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This work was supported by the Irish Research Council [GOIPG/2022/444].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

version 2

Revised

Published: 06 Dec 2024, 7:29

https://doi.org/10.12688/hrbopenres.13878.2

version 1

Published: 20 May 2024, 7:29

https://doi.org/10.12688/hrbopenres.13878.1

© 2024 Roche KF 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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Roche KF, Maher A, Morrissey EC et al. The use of small group based educational interventions in General Practice to improve antibiotic prescribing behaviours: a mixed methods systematic review protocol [version 2; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2024, 7:29 (https://doi.org/10.12688/hrbopenres.13878.2)

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Open Peer Review

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PUBLISHED 06 Dec 2024

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Reviewer Report 07 Jan 2025

Nathaly Garzón-Orjuela, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland

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https://doi.org/10.21956/hrbopenres.15280.r43567

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Reviewer Report 11 Jun 2024

Derek Stewart, College of Pharmacy, QU Health, Qatar University, Doha, Qatar

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15215.r40541

HRB Open Research
The use of small group based educational interventions in General Practice to improve antimicrobial prescribing behaviours: a mixed methods systematic review protocol

Reviewer’s report, 09 June 2024

Many thanks for inviting me to comment on the above review protocol. Evidence syntheses in the field of antimicrobial prescribing are to be welcomed given the need to improve practice at the global level. The protocol is generally well-written but is lacking in detail and coherence at specific points.
I hope that the following comments are of use.

Abstract
Specific comments
Background – the terms ‘primary care’ and ‘general practice’ are both used. Is this intended? More importantly, while the title refers to ‘antimicrobials’, this has changed in the background to ‘antibiotics’. These are not the same and must be corrected and standardized throughout. The aim of the review is rather vague and needs to be much more specific in terms of the PICO elements.
Methods – need to update the search date to the date of the search and not February 2024. ‘Group-based’ is not defined. See above relating to PICO and the specific elements which are still unclear. The method does not include the appropriate focus on data extraction and quality assessment which should be independently performed for all papers. How are the interventions ’coded’?

Introduction
The authors provide justification for the focus on antibiotics, but this is not sufficiently convincing, and I suggest that the authors consider extending to antimicrobials. Should they retain the antibiotic focus then the title must change accordingly.
Does inappropriate prescribing not also encompass selection of an inappropriate agent, incorrect duration, dose etc.? The definition provided seems rather limited.
Clinicians other than doctors can prescribe antimicrobials/antibiotics in many countries hence need to change the focus from just doctors.
There is no justification provided for the focus on group-based educational interventions rather than other forms of educational intervention (e.g., one-to-one). There is also no coverage of other related evidence syntheses in this field. The authors need to provide greater rationale for this review. See earlier comment on the aim.

Objectives
Why restrict the review to ‘in person’ interventions? Many interventions could be online etc. The objectives requires some rephrasing and presenting as numbered/bulleted objectives which map to the aim. Identifying components should precede efficacy and effectiveness. Why ‘efficacy’ and ‘potential effectiveness’? What is meant by ‘insights’ and does ‘participants’ include the education provider or patient perspective?

Methods
The review is appropriately designed in terms of the JBI mixed methods review approach. Excellent to read of detailed stakeholder involvement but why only those with a medical background and what about expert patients? Stakeholder involvement reads more as reviewer involvement.
Small group intervention is now more clearly defined. How will these phenomena be operationalized? For example, if the studies do not describe all 3 elements, will they be excluded? These elements do not feature in the data extraction section.
Participants – see earlier comments and suggest that this is extended to any prescriber/prescriber group. All prescribers should be included.
As before, why exclude non-face-to-face education?
Intervention – not clear for the qualitative studies. In this section, the authors are not describing the intervention but more the outcomes. Needs much more detail on how to record the intervention and its components.
Comparator – are studies excluded if no comparator (e.g., qualitative studies).
Outcomes – need to clarify the differences between efficacy and effectiveness studies. Some of the secondary outcomes are measures of intervention process (e.g., content of the material) and are not outcomes.
Study selection – see earlier comments. In addition, while the abstract states 20% second review, this is now 25%.
Data extraction – needs emphasis on the specific intervention, components etc. This is the first mention of facilitators and barriers. I suggest that this section is mapped to the review objectives (same for the synthesis section).
Data synthesis requires more detail – who is involved, quality assurance etc.
Risk of bias – see above. Suggest that all data extraction and quality assessment is 100% independently double reviewed.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Clinical pharmacy; prescribing

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, however I have significant reservations, as outlined above.

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Author Response 06 Dec 2024

Kevin Roche, School of Psychology, University of Galway, Galway, Ireland

06 Dec 2024

Author Response

Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel ... Continue reading Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel that by incorporating your recommendations and suggestions that it has improved the manuscript and made the protocol more robust. We have addressed your points below and within the main body of the text.

Abstract
Specific comments
1.Background – the terms ‘primary care’ and ‘general practice’ are both used. Is this intended?
Our intention here is that when discussing ‘primary care’ we include other prescribing healthcare professionals e.g. pharmacists, advanced nurse practitioners, prescribing public health or practice nurses working in non-secondary care settings could be included. When we refer to ‘general practice’ we are specifically referring to General Practitioners or General Practice registrars (trainees). Due to the very strict word count allowed for an abstract by HRB-OPEN it was not possible to specify this in the abstract. We clarify this in the last two sentences of the third paragraph of the introduction section, Page 4.

2. More importantly, while the title refers to ‘antimicrobials’, this has changed in the background to ‘antibiotics’. These are not the same and must be corrected and standardized throughout.
Thank you for highlighting this, we have changed this per your recommendation.

3. The aim of the review is rather vague and needs to be much more specific in terms of the PICO elements.
We agree, however as above due to the 300-word limit on abstracts for HRB-OPEN it was not possible to provide that level of detail in the abstract.

4. Methods – need to update the search date to the date of the search and not February 2024.
Thank you this has now been updated in both sources section and the study status section.

5. ‘Group-based’ is not defined. See above relating to PICO and the specific elements which are still unclear. The method does not include the appropriate focus on data extraction and quality assessment which should be independently performed for all papers.
Thank you for your comment on this. As we have discussed above the word count limit for the abstract is 300 words maximum and it is not possible to provide a high degree of detail in the abstract.

6. How are the interventions ’coded’?
Please see above reply re: abstract length.

7. Introduction
The authors provide justification for the focus on antibiotics, but this is not sufficiently convincing, and I suggest that the authors consider extending to antimicrobials. Should they retain the antibiotic focus then the title must change accordingly.
Thank you for highlighting this, the title has been amended accordingly.

8. Does inappropriate prescribing not also encompass selection of an inappropriate agent, incorrect duration, dose etc.? The definition provided seems rather limited.
Thank you for pointing out this omission, we have amended our definition to include your suggestions.

9. Clinicians other than doctors can prescribe antimicrobials/antibiotics in many countries hence need to change the focus from just doctors.
Thank you for highlighting this, we recognise that in many countries clinicians other than medical doctors can prescribe antibiotics however as we are using the findings from this review to inform the design and content of a small group educational intervention for Irish General Practice registrars, we have opted to only review the data specific to General Practitioners. We have now included this acknowledgment at the end of the discussion section, page 10.

10. There is no justification provided for the focus on group-based educational interventions rather than other forms of educational intervention (e.g., one-to-one). There is also no coverage of other related evidence syntheses in this field. The authors need to provide greater rationale for this review. See earlier comment on the aim.
Thank you for this feedback. We have now included in the manuscript our rationale that an aim of this systematic review is to inform the design and content of a contextualised intervention for GP registrars. The format of this intervention will be a co-designed theory informed peer led in-person small group-based educational intervention. We have also added additional information on pages 3 & 4 that provides additional rationale.

Objectives
11. Why restrict the review to ‘in person’ interventions? Many interventions could be online etc. The objectives requires some rephrasing and presenting as numbered/bulleted objectives which map to the aim. Identifying components should precede efficacy and effectiveness. Why ‘efficacy’ and ‘potential effectiveness’?
Thank you for this comment, we feel that having taken your other suggestions regarding adjusting the rationale that we have addressed why we are limiting the review to in-person interventions (Page 4). By rephrasing and including your suggested clarifying information in the objectives section we feel that this section is now stronger. Thank you for your helpful insights.

12. What is meant by ‘insights’ and does ‘participants’ include the education provider or patient perspective?
We are using the term ‘insights’ as a hold all label for the qualitative findings. ‘Participants’ will include education provider and we have included this in the manuscript, thank you for highlighting this as including it will help clarify.
However, as we are focusing on interventions aimed at General Practitioners / General Practice registrars we will not be reporting patient perspectives. A patient-oriented scoping review is also being conducted separately by the research team and this will inform the broader programme of work. Please see:
Maher A, Roche K, C Morrissey E et al. Behaviour change interventions addressing antibiotic treatment seeking behaviour for respiratory tract infections in primary care settings: A scoping review protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2024, 7:41 (https://doi.org/10.12688/hrbopenres.13831.1)

Methods
13. The review is appropriately designed in terms of the JBI mixed methods review approach. Excellent to read of detailed stakeholder involvement but why only those with a medical background and what about expert patients? Stakeholder involvement reads more as reviewer involvement.
Thank you. This review is part of a broader multi-faceted programme of work currently underway that does include PPI however as the current review is focused on GPs / GP registrars our interpretation of stakeholder used here is only in the context of the review. We considered our stakeholder involvement for the current review based on the ACTIVE framework (https://training.cochrane.org/involving-people) there are expert patients and patient contributors in the broader research project, and they will have input in the final intervention design that this review will inform.

14. Small group intervention is now more clearly defined. How will these phenomena be operationalized? For example, if the studies do not describe all 3 elements, will they be excluded? These elements do not feature in the data extraction section.
Studies will not be excluded if they do not list or describe the three features that we consider pertinent to small group interventions however at full text screening level we will review and record the degree to which the intervention reports on these. This information will be recorded under the intervention characteristics section.

15. Participants – see earlier comments and suggest that this is extended to any prescriber/prescriber group. All prescribers should be included.
As discussed above an aim of this review is to inform the content and development of an intervention aimed at GP registrars. Currently in Ireland where the intervention is being developed in Primary Care only GPs / GP registrars under supervision can prescribe antibiotics.

16. As before, why exclude non-face-to-face education?
The reason we are excluding non-face-to-face education is that we are aiming to use our findings from this systematic review to inform the content and design of a contextualised intervention for GP registrars. We are only including studies that will help edify the intervention.

17. In this section, the authors are not describing the intervention but more the outcomes. Needs much more detail on how to record the intervention and its components.
Thank you for highlighting this. We have amended the original text based on your feedback.

18. Comparator – are studies excluded if no comparator (e.g., qualitative studies).
No, as this is a mixed methods systematic review we will be including quantitative, qualitative and mixed – methods studies providing they are relevant to the phenomenon of interest. We have amended this section following a suggestion from reviewer 1.

19. Outcomes – need to clarify the differences between efficacy and effectiveness studies. Some of the secondary outcomes are measures of intervention process (e.g., content of the material) and are not outcomes.
Thank you for highlighting this for us we have now omitted this section as having considered the feedback from both reviewers and having read further examples of published reviews we feel that it’s inclusion is not warranted for this mixed methods systematic review.

20. Study selection – see earlier comments. In addition, while the abstract states 20% second review, this is now 25%.
Thank you for spotting this, we have amended the manuscript.

21. Data extraction – needs emphasis on the specific intervention, components etc.
Thank you for highlighting this. We have added greater detail to the data extraction section that we feel addresses your suggestion.

22. This is the first mention of facilitators and barriers. I suggest that this section is mapped to the review objectives (same for the synthesis section).
Thank you for this very valid and helpful point. We have now added this to the objectives, as per your suggestion and clarified that we are also including content from intervention providers if it is reported.

23. Data synthesis requires more detail – who is involved, quality assurance etc.
Thank you for this suggestion. We have added more detail to the data synthesis section and we feel that it now answered.

24. Risk of bias – see above. Suggest that all data extraction and quality assessment is 100% independently double reviewed.
This is a very valid suggestion and ideally one we would like to carry out. However as discussed above due to the constraints of the work packages of the programme of work it is not possible. We are using a methodology that has been successfully employed in the conduct of other systematic reviews
e.g. https://doi.org/10.1080/17437199.2023.2185653
Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel that by incorporating your recommendations and suggestions that it has improved the manuscript and made the protocol more robust. We have addressed your points below and within the main body of the text.

Abstract
Specific comments
1.Background – the terms ‘primary care’ and ‘general practice’ are both used. Is this intended?
Our intention here is that when discussing ‘primary care’ we include other prescribing healthcare professionals e.g. pharmacists, advanced nurse practitioners, prescribing public health or practice nurses working in non-secondary care settings could be included. When we refer to ‘general practice’ we are specifically referring to General Practitioners or General Practice registrars (trainees). Due to the very strict word count allowed for an abstract by HRB-OPEN it was not possible to specify this in the abstract. We clarify this in the last two sentences of the third paragraph of the introduction section, Page 4.

2. More importantly, while the title refers to ‘antimicrobials’, this has changed in the background to ‘antibiotics’. These are not the same and must be corrected and standardized throughout.
Thank you for highlighting this, we have changed this per your recommendation.

3. The aim of the review is rather vague and needs to be much more specific in terms of the PICO elements.
We agree, however as above due to the 300-word limit on abstracts for HRB-OPEN it was not possible to provide that level of detail in the abstract.

4. Methods – need to update the search date to the date of the search and not February 2024.
Thank you this has now been updated in both sources section and the study status section.

5. ‘Group-based’ is not defined. See above relating to PICO and the specific elements which are still unclear. The method does not include the appropriate focus on data extraction and quality assessment which should be independently performed for all papers.
Thank you for your comment on this. As we have discussed above the word count limit for the abstract is 300 words maximum and it is not possible to provide a high degree of detail in the abstract.

6. How are the interventions ’coded’?
Please see above reply re: abstract length.

7. Introduction
The authors provide justification for the focus on antibiotics, but this is not sufficiently convincing, and I suggest that the authors consider extending to antimicrobials. Should they retain the antibiotic focus then the title must change accordingly.
Thank you for highlighting this, the title has been amended accordingly.

8. Does inappropriate prescribing not also encompass selection of an inappropriate agent, incorrect duration, dose etc.? The definition provided seems rather limited.
Thank you for pointing out this omission, we have amended our definition to include your suggestions.

9. Clinicians other than doctors can prescribe antimicrobials/antibiotics in many countries hence need to change the focus from just doctors.
Thank you for highlighting this, we recognise that in many countries clinicians other than medical doctors can prescribe antibiotics however as we are using the findings from this review to inform the design and content of a small group educational intervention for Irish General Practice registrars, we have opted to only review the data specific to General Practitioners. We have now included this acknowledgment at the end of the discussion section, page 10.

10. There is no justification provided for the focus on group-based educational interventions rather than other forms of educational intervention (e.g., one-to-one). There is also no coverage of other related evidence syntheses in this field. The authors need to provide greater rationale for this review. See earlier comment on the aim.
Thank you for this feedback. We have now included in the manuscript our rationale that an aim of this systematic review is to inform the design and content of a contextualised intervention for GP registrars. The format of this intervention will be a co-designed theory informed peer led in-person small group-based educational intervention. We have also added additional information on pages 3 & 4 that provides additional rationale.

Objectives
11. Why restrict the review to ‘in person’ interventions? Many interventions could be online etc. The objectives requires some rephrasing and presenting as numbered/bulleted objectives which map to the aim. Identifying components should precede efficacy and effectiveness. Why ‘efficacy’ and ‘potential effectiveness’?
Thank you for this comment, we feel that having taken your other suggestions regarding adjusting the rationale that we have addressed why we are limiting the review to in-person interventions (Page 4). By rephrasing and including your suggested clarifying information in the objectives section we feel that this section is now stronger. Thank you for your helpful insights.

12. What is meant by ‘insights’ and does ‘participants’ include the education provider or patient perspective?
We are using the term ‘insights’ as a hold all label for the qualitative findings. ‘Participants’ will include education provider and we have included this in the manuscript, thank you for highlighting this as including it will help clarify.
However, as we are focusing on interventions aimed at General Practitioners / General Practice registrars we will not be reporting patient perspectives. A patient-oriented scoping review is also being conducted separately by the research team and this will inform the broader programme of work. Please see:
Maher A, Roche K, C Morrissey E et al. Behaviour change interventions addressing antibiotic treatment seeking behaviour for respiratory tract infections in primary care settings: A scoping review protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2024, 7:41 (https://doi.org/10.12688/hrbopenres.13831.1)

Methods
13. The review is appropriately designed in terms of the JBI mixed methods review approach. Excellent to read of detailed stakeholder involvement but why only those with a medical background and what about expert patients? Stakeholder involvement reads more as reviewer involvement.
Thank you. This review is part of a broader multi-faceted programme of work currently underway that does include PPI however as the current review is focused on GPs / GP registrars our interpretation of stakeholder used here is only in the context of the review. We considered our stakeholder involvement for the current review based on the ACTIVE framework (https://training.cochrane.org/involving-people) there are expert patients and patient contributors in the broader research project, and they will have input in the final intervention design that this review will inform.

14. Small group intervention is now more clearly defined. How will these phenomena be operationalized? For example, if the studies do not describe all 3 elements, will they be excluded? These elements do not feature in the data extraction section.
Studies will not be excluded if they do not list or describe the three features that we consider pertinent to small group interventions however at full text screening level we will review and record the degree to which the intervention reports on these. This information will be recorded under the intervention characteristics section.

15. Participants – see earlier comments and suggest that this is extended to any prescriber/prescriber group. All prescribers should be included.
As discussed above an aim of this review is to inform the content and development of an intervention aimed at GP registrars. Currently in Ireland where the intervention is being developed in Primary Care only GPs / GP registrars under supervision can prescribe antibiotics.

16. As before, why exclude non-face-to-face education?
The reason we are excluding non-face-to-face education is that we are aiming to use our findings from this systematic review to inform the content and design of a contextualised intervention for GP registrars. We are only including studies that will help edify the intervention.

17. In this section, the authors are not describing the intervention but more the outcomes. Needs much more detail on how to record the intervention and its components.
Thank you for highlighting this. We have amended the original text based on your feedback.

18. Comparator – are studies excluded if no comparator (e.g., qualitative studies).
No, as this is a mixed methods systematic review we will be including quantitative, qualitative and mixed – methods studies providing they are relevant to the phenomenon of interest. We have amended this section following a suggestion from reviewer 1.

19. Outcomes – need to clarify the differences between efficacy and effectiveness studies. Some of the secondary outcomes are measures of intervention process (e.g., content of the material) and are not outcomes.
Thank you for highlighting this for us we have now omitted this section as having considered the feedback from both reviewers and having read further examples of published reviews we feel that it’s inclusion is not warranted for this mixed methods systematic review.

20. Study selection – see earlier comments. In addition, while the abstract states 20% second review, this is now 25%.
Thank you for spotting this, we have amended the manuscript.

21. Data extraction – needs emphasis on the specific intervention, components etc.
Thank you for highlighting this. We have added greater detail to the data extraction section that we feel addresses your suggestion.

22. This is the first mention of facilitators and barriers. I suggest that this section is mapped to the review objectives (same for the synthesis section).
Thank you for this very valid and helpful point. We have now added this to the objectives, as per your suggestion and clarified that we are also including content from intervention providers if it is reported.

23. Data synthesis requires more detail – who is involved, quality assurance etc.
Thank you for this suggestion. We have added more detail to the data synthesis section and we feel that it now answered.

24. Risk of bias – see above. Suggest that all data extraction and quality assessment is 100% independently double reviewed.
This is a very valid suggestion and ideally one we would like to carry out. However as discussed above due to the constraints of the work packages of the programme of work it is not possible. We are using a methodology that has been successfully employed in the conduct of other systematic reviews
e.g. https://doi.org/10.1080/17437199.2023.2185653
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 06 Dec 2024

Kevin Roche, School of Psychology, University of Galway, Galway, Ireland

06 Dec 2024

Author Response

Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel ... Continue reading Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel that by incorporating your recommendations and suggestions that it has improved the manuscript and made the protocol more robust. We have addressed your points below and within the main body of the text.

Abstract
Specific comments
1.Background – the terms ‘primary care’ and ‘general practice’ are both used. Is this intended?
Our intention here is that when discussing ‘primary care’ we include other prescribing healthcare professionals e.g. pharmacists, advanced nurse practitioners, prescribing public health or practice nurses working in non-secondary care settings could be included. When we refer to ‘general practice’ we are specifically referring to General Practitioners or General Practice registrars (trainees). Due to the very strict word count allowed for an abstract by HRB-OPEN it was not possible to specify this in the abstract. We clarify this in the last two sentences of the third paragraph of the introduction section, Page 4.

2. More importantly, while the title refers to ‘antimicrobials’, this has changed in the background to ‘antibiotics’. These are not the same and must be corrected and standardized throughout.
Thank you for highlighting this, we have changed this per your recommendation.

3. The aim of the review is rather vague and needs to be much more specific in terms of the PICO elements.
We agree, however as above due to the 300-word limit on abstracts for HRB-OPEN it was not possible to provide that level of detail in the abstract.

4. Methods – need to update the search date to the date of the search and not February 2024.
Thank you this has now been updated in both sources section and the study status section.

5. ‘Group-based’ is not defined. See above relating to PICO and the specific elements which are still unclear. The method does not include the appropriate focus on data extraction and quality assessment which should be independently performed for all papers.
Thank you for your comment on this. As we have discussed above the word count limit for the abstract is 300 words maximum and it is not possible to provide a high degree of detail in the abstract.

6. How are the interventions ’coded’?
Please see above reply re: abstract length.

7. Introduction
The authors provide justification for the focus on antibiotics, but this is not sufficiently convincing, and I suggest that the authors consider extending to antimicrobials. Should they retain the antibiotic focus then the title must change accordingly.
Thank you for highlighting this, the title has been amended accordingly.

8. Does inappropriate prescribing not also encompass selection of an inappropriate agent, incorrect duration, dose etc.? The definition provided seems rather limited.
Thank you for pointing out this omission, we have amended our definition to include your suggestions.

9. Clinicians other than doctors can prescribe antimicrobials/antibiotics in many countries hence need to change the focus from just doctors.
Thank you for highlighting this, we recognise that in many countries clinicians other than medical doctors can prescribe antibiotics however as we are using the findings from this review to inform the design and content of a small group educational intervention for Irish General Practice registrars, we have opted to only review the data specific to General Practitioners. We have now included this acknowledgment at the end of the discussion section, page 10.

10. There is no justification provided for the focus on group-based educational interventions rather than other forms of educational intervention (e.g., one-to-one). There is also no coverage of other related evidence syntheses in this field. The authors need to provide greater rationale for this review. See earlier comment on the aim.
Thank you for this feedback. We have now included in the manuscript our rationale that an aim of this systematic review is to inform the design and content of a contextualised intervention for GP registrars. The format of this intervention will be a co-designed theory informed peer led in-person small group-based educational intervention. We have also added additional information on pages 3 & 4 that provides additional rationale.

Objectives
11. Why restrict the review to ‘in person’ interventions? Many interventions could be online etc. The objectives requires some rephrasing and presenting as numbered/bulleted objectives which map to the aim. Identifying components should precede efficacy and effectiveness. Why ‘efficacy’ and ‘potential effectiveness’?
Thank you for this comment, we feel that having taken your other suggestions regarding adjusting the rationale that we have addressed why we are limiting the review to in-person interventions (Page 4). By rephrasing and including your suggested clarifying information in the objectives section we feel that this section is now stronger. Thank you for your helpful insights.

12. What is meant by ‘insights’ and does ‘participants’ include the education provider or patient perspective?
We are using the term ‘insights’ as a hold all label for the qualitative findings. ‘Participants’ will include education provider and we have included this in the manuscript, thank you for highlighting this as including it will help clarify.
However, as we are focusing on interventions aimed at General Practitioners / General Practice registrars we will not be reporting patient perspectives. A patient-oriented scoping review is also being conducted separately by the research team and this will inform the broader programme of work. Please see:
Maher A, Roche K, C Morrissey E et al. Behaviour change interventions addressing antibiotic treatment seeking behaviour for respiratory tract infections in primary care settings: A scoping review protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2024, 7:41 (https://doi.org/10.12688/hrbopenres.13831.1)

Methods
13. The review is appropriately designed in terms of the JBI mixed methods review approach. Excellent to read of detailed stakeholder involvement but why only those with a medical background and what about expert patients? Stakeholder involvement reads more as reviewer involvement.
Thank you. This review is part of a broader multi-faceted programme of work currently underway that does include PPI however as the current review is focused on GPs / GP registrars our interpretation of stakeholder used here is only in the context of the review. We considered our stakeholder involvement for the current review based on the ACTIVE framework (https://training.cochrane.org/involving-people) there are expert patients and patient contributors in the broader research project, and they will have input in the final intervention design that this review will inform.

14. Small group intervention is now more clearly defined. How will these phenomena be operationalized? For example, if the studies do not describe all 3 elements, will they be excluded? These elements do not feature in the data extraction section.
Studies will not be excluded if they do not list or describe the three features that we consider pertinent to small group interventions however at full text screening level we will review and record the degree to which the intervention reports on these. This information will be recorded under the intervention characteristics section.

15. Participants – see earlier comments and suggest that this is extended to any prescriber/prescriber group. All prescribers should be included.
As discussed above an aim of this review is to inform the content and development of an intervention aimed at GP registrars. Currently in Ireland where the intervention is being developed in Primary Care only GPs / GP registrars under supervision can prescribe antibiotics.

16. As before, why exclude non-face-to-face education?
The reason we are excluding non-face-to-face education is that we are aiming to use our findings from this systematic review to inform the content and design of a contextualised intervention for GP registrars. We are only including studies that will help edify the intervention.

17. In this section, the authors are not describing the intervention but more the outcomes. Needs much more detail on how to record the intervention and its components.
Thank you for highlighting this. We have amended the original text based on your feedback.

18. Comparator – are studies excluded if no comparator (e.g., qualitative studies).
No, as this is a mixed methods systematic review we will be including quantitative, qualitative and mixed – methods studies providing they are relevant to the phenomenon of interest. We have amended this section following a suggestion from reviewer 1.

19. Outcomes – need to clarify the differences between efficacy and effectiveness studies. Some of the secondary outcomes are measures of intervention process (e.g., content of the material) and are not outcomes.
Thank you for highlighting this for us we have now omitted this section as having considered the feedback from both reviewers and having read further examples of published reviews we feel that it’s inclusion is not warranted for this mixed methods systematic review.

20. Study selection – see earlier comments. In addition, while the abstract states 20% second review, this is now 25%.
Thank you for spotting this, we have amended the manuscript.

21. Data extraction – needs emphasis on the specific intervention, components etc.
Thank you for highlighting this. We have added greater detail to the data extraction section that we feel addresses your suggestion.

22. This is the first mention of facilitators and barriers. I suggest that this section is mapped to the review objectives (same for the synthesis section).
Thank you for this very valid and helpful point. We have now added this to the objectives, as per your suggestion and clarified that we are also including content from intervention providers if it is reported.

23. Data synthesis requires more detail – who is involved, quality assurance etc.
Thank you for this suggestion. We have added more detail to the data synthesis section and we feel that it now answered.

24. Risk of bias – see above. Suggest that all data extraction and quality assessment is 100% independently double reviewed.
This is a very valid suggestion and ideally one we would like to carry out. However as discussed above due to the constraints of the work packages of the programme of work it is not possible. We are using a methodology that has been successfully employed in the conduct of other systematic reviews
e.g. https://doi.org/10.1080/17437199.2023.2185653
Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel that by incorporating your recommendations and suggestions that it has improved the manuscript and made the protocol more robust. We have addressed your points below and within the main body of the text.

Abstract
Specific comments
1.Background – the terms ‘primary care’ and ‘general practice’ are both used. Is this intended?
Our intention here is that when discussing ‘primary care’ we include other prescribing healthcare professionals e.g. pharmacists, advanced nurse practitioners, prescribing public health or practice nurses working in non-secondary care settings could be included. When we refer to ‘general practice’ we are specifically referring to General Practitioners or General Practice registrars (trainees). Due to the very strict word count allowed for an abstract by HRB-OPEN it was not possible to specify this in the abstract. We clarify this in the last two sentences of the third paragraph of the introduction section, Page 4.

2. More importantly, while the title refers to ‘antimicrobials’, this has changed in the background to ‘antibiotics’. These are not the same and must be corrected and standardized throughout.
Thank you for highlighting this, we have changed this per your recommendation.

3. The aim of the review is rather vague and needs to be much more specific in terms of the PICO elements.
We agree, however as above due to the 300-word limit on abstracts for HRB-OPEN it was not possible to provide that level of detail in the abstract.

4. Methods – need to update the search date to the date of the search and not February 2024.
Thank you this has now been updated in both sources section and the study status section.

5. ‘Group-based’ is not defined. See above relating to PICO and the specific elements which are still unclear. The method does not include the appropriate focus on data extraction and quality assessment which should be independently performed for all papers.
Thank you for your comment on this. As we have discussed above the word count limit for the abstract is 300 words maximum and it is not possible to provide a high degree of detail in the abstract.

6. How are the interventions ’coded’?
Please see above reply re: abstract length.

7. Introduction
The authors provide justification for the focus on antibiotics, but this is not sufficiently convincing, and I suggest that the authors consider extending to antimicrobials. Should they retain the antibiotic focus then the title must change accordingly.
Thank you for highlighting this, the title has been amended accordingly.

8. Does inappropriate prescribing not also encompass selection of an inappropriate agent, incorrect duration, dose etc.? The definition provided seems rather limited.
Thank you for pointing out this omission, we have amended our definition to include your suggestions.

9. Clinicians other than doctors can prescribe antimicrobials/antibiotics in many countries hence need to change the focus from just doctors.
Thank you for highlighting this, we recognise that in many countries clinicians other than medical doctors can prescribe antibiotics however as we are using the findings from this review to inform the design and content of a small group educational intervention for Irish General Practice registrars, we have opted to only review the data specific to General Practitioners. We have now included this acknowledgment at the end of the discussion section, page 10.

10. There is no justification provided for the focus on group-based educational interventions rather than other forms of educational intervention (e.g., one-to-one). There is also no coverage of other related evidence syntheses in this field. The authors need to provide greater rationale for this review. See earlier comment on the aim.
Thank you for this feedback. We have now included in the manuscript our rationale that an aim of this systematic review is to inform the design and content of a contextualised intervention for GP registrars. The format of this intervention will be a co-designed theory informed peer led in-person small group-based educational intervention. We have also added additional information on pages 3 & 4 that provides additional rationale.

Objectives
11. Why restrict the review to ‘in person’ interventions? Many interventions could be online etc. The objectives requires some rephrasing and presenting as numbered/bulleted objectives which map to the aim. Identifying components should precede efficacy and effectiveness. Why ‘efficacy’ and ‘potential effectiveness’?
Thank you for this comment, we feel that having taken your other suggestions regarding adjusting the rationale that we have addressed why we are limiting the review to in-person interventions (Page 4). By rephrasing and including your suggested clarifying information in the objectives section we feel that this section is now stronger. Thank you for your helpful insights.

12. What is meant by ‘insights’ and does ‘participants’ include the education provider or patient perspective?
We are using the term ‘insights’ as a hold all label for the qualitative findings. ‘Participants’ will include education provider and we have included this in the manuscript, thank you for highlighting this as including it will help clarify.
However, as we are focusing on interventions aimed at General Practitioners / General Practice registrars we will not be reporting patient perspectives. A patient-oriented scoping review is also being conducted separately by the research team and this will inform the broader programme of work. Please see:
Maher A, Roche K, C Morrissey E et al. Behaviour change interventions addressing antibiotic treatment seeking behaviour for respiratory tract infections in primary care settings: A scoping review protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2024, 7:41 (https://doi.org/10.12688/hrbopenres.13831.1)

Methods
13. The review is appropriately designed in terms of the JBI mixed methods review approach. Excellent to read of detailed stakeholder involvement but why only those with a medical background and what about expert patients? Stakeholder involvement reads more as reviewer involvement.
Thank you. This review is part of a broader multi-faceted programme of work currently underway that does include PPI however as the current review is focused on GPs / GP registrars our interpretation of stakeholder used here is only in the context of the review. We considered our stakeholder involvement for the current review based on the ACTIVE framework (https://training.cochrane.org/involving-people) there are expert patients and patient contributors in the broader research project, and they will have input in the final intervention design that this review will inform.

14. Small group intervention is now more clearly defined. How will these phenomena be operationalized? For example, if the studies do not describe all 3 elements, will they be excluded? These elements do not feature in the data extraction section.
Studies will not be excluded if they do not list or describe the three features that we consider pertinent to small group interventions however at full text screening level we will review and record the degree to which the intervention reports on these. This information will be recorded under the intervention characteristics section.

15. Participants – see earlier comments and suggest that this is extended to any prescriber/prescriber group. All prescribers should be included.
As discussed above an aim of this review is to inform the content and development of an intervention aimed at GP registrars. Currently in Ireland where the intervention is being developed in Primary Care only GPs / GP registrars under supervision can prescribe antibiotics.

16. As before, why exclude non-face-to-face education?
The reason we are excluding non-face-to-face education is that we are aiming to use our findings from this systematic review to inform the content and design of a contextualised intervention for GP registrars. We are only including studies that will help edify the intervention.

17. In this section, the authors are not describing the intervention but more the outcomes. Needs much more detail on how to record the intervention and its components.
Thank you for highlighting this. We have amended the original text based on your feedback.

18. Comparator – are studies excluded if no comparator (e.g., qualitative studies).
No, as this is a mixed methods systematic review we will be including quantitative, qualitative and mixed – methods studies providing they are relevant to the phenomenon of interest. We have amended this section following a suggestion from reviewer 1.

19. Outcomes – need to clarify the differences between efficacy and effectiveness studies. Some of the secondary outcomes are measures of intervention process (e.g., content of the material) and are not outcomes.
Thank you for highlighting this for us we have now omitted this section as having considered the feedback from both reviewers and having read further examples of published reviews we feel that it’s inclusion is not warranted for this mixed methods systematic review.

20. Study selection – see earlier comments. In addition, while the abstract states 20% second review, this is now 25%.
Thank you for spotting this, we have amended the manuscript.

21. Data extraction – needs emphasis on the specific intervention, components etc.
Thank you for highlighting this. We have added greater detail to the data extraction section that we feel addresses your suggestion.

22. This is the first mention of facilitators and barriers. I suggest that this section is mapped to the review objectives (same for the synthesis section).
Thank you for this very valid and helpful point. We have now added this to the objectives, as per your suggestion and clarified that we are also including content from intervention providers if it is reported.

23. Data synthesis requires more detail – who is involved, quality assurance etc.
Thank you for this suggestion. We have added more detail to the data synthesis section and we feel that it now answered.

24. Risk of bias – see above. Suggest that all data extraction and quality assessment is 100% independently double reviewed.
This is a very valid suggestion and ideally one we would like to carry out. However as discussed above due to the constraints of the work packages of the programme of work it is not possible. We are using a methodology that has been successfully employed in the conduct of other systematic reviews
e.g. https://doi.org/10.1080/17437199.2023.2185653
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 08 Jun 2024

Nathaly Garzón-Orjuela, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15215.r40200

I am grateful for the opportunity to review this protocol. Upon reviewing the protocol, I have noted the following observations:

The title and objective differ in the size of the group; the title focuses on "small

I am grateful for the opportunity to review this protocol. Upon reviewing the protocol, I have noted the following observations:

The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviors such as video conferencing or online modules, peer comparison.....
The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly

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?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Epidemiology, Systematic review, Meta-analysis, Network meta-analysis, Scoping review, Nutrition, Antibiotic prescription, Health Equity and Data analysis.

CITE

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Author Response 06 Dec 2024

Kevin Roche, School of Psychology, University of Galway, Galway, Ireland

06 Dec 2024

Author Response

Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions ... Continue reading Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions into our revised manuscript. We feel that by incorporating the changes that you have suggested we have made the protocol more robust and greatly appreciate the time you have taken to review it.

1.    The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

2.    The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Thank you for pointing this out. We have now amended the text in particular the introductory section to clarify our phenomenon of interest and also the rationale for it. We have edited the inclusion criteria to take this feedback into account.

3.    Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

4.    The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
Thank you for suggesting this, we have now amended the protocol to address this point and have developed this point further in the introduction section.

5.    The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviours such as video conferencing or online modules, peer comparison.....
Thank you for this point, we have amended the comparators section as per your suggestion to make it more suitable for a mixed methods systematic review.

6.    The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
Thank you for this suggestion, we have moved this sentence to the sources section as recommended and deleted it from the types of studies section.

7.    The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
Thank you for highlighting this, the text has now been amended to specify that it is OVID Medline.

8.    The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly.
Thank you for this suggestion we have now amended the manuscript to reflect better the format outlined by the JBI guidance for conducting mixed method systematic reviews.
Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions into our revised manuscript. We feel that by incorporating the changes that you have suggested we have made the protocol more robust and greatly appreciate the time you have taken to review it.

1.    The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

2.    The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Thank you for pointing this out. We have now amended the text in particular the introductory section to clarify our phenomenon of interest and also the rationale for it. We have edited the inclusion criteria to take this feedback into account.

3.    Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

4.    The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
Thank you for suggesting this, we have now amended the protocol to address this point and have developed this point further in the introduction section.

5.    The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviours such as video conferencing or online modules, peer comparison.....
Thank you for this point, we have amended the comparators section as per your suggestion to make it more suitable for a mixed methods systematic review.

6.    The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
Thank you for this suggestion, we have moved this sentence to the sources section as recommended and deleted it from the types of studies section.

7.    The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
Thank you for highlighting this, the text has now been amended to specify that it is OVID Medline.

8.    The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly.
Thank you for this suggestion we have now amended the manuscript to reflect better the format outlined by the JBI guidance for conducting mixed method systematic reviews.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 06 Dec 2024

Kevin Roche, School of Psychology, University of Galway, Galway, Ireland

06 Dec 2024

Author Response

Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions ... Continue reading Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions into our revised manuscript. We feel that by incorporating the changes that you have suggested we have made the protocol more robust and greatly appreciate the time you have taken to review it.

1.    The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

2.    The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Thank you for pointing this out. We have now amended the text in particular the introductory section to clarify our phenomenon of interest and also the rationale for it. We have edited the inclusion criteria to take this feedback into account.

3.    Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

4.    The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
Thank you for suggesting this, we have now amended the protocol to address this point and have developed this point further in the introduction section.

5.    The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviours such as video conferencing or online modules, peer comparison.....
Thank you for this point, we have amended the comparators section as per your suggestion to make it more suitable for a mixed methods systematic review.

6.    The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
Thank you for this suggestion, we have moved this sentence to the sources section as recommended and deleted it from the types of studies section.

7.    The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
Thank you for highlighting this, the text has now been amended to specify that it is OVID Medline.

8.    The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly.
Thank you for this suggestion we have now amended the manuscript to reflect better the format outlined by the JBI guidance for conducting mixed method systematic reviews.
Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions into our revised manuscript. We feel that by incorporating the changes that you have suggested we have made the protocol more robust and greatly appreciate the time you have taken to review it.

1.    The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

2.    The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Thank you for pointing this out. We have now amended the text in particular the introductory section to clarify our phenomenon of interest and also the rationale for it. We have edited the inclusion criteria to take this feedback into account.

3.    Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

4.    The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
Thank you for suggesting this, we have now amended the protocol to address this point and have developed this point further in the introduction section.

5.    The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviours such as video conferencing or online modules, peer comparison.....
Thank you for this point, we have amended the comparators section as per your suggestion to make it more suitable for a mixed methods systematic review.

6.    The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
Thank you for this suggestion, we have moved this sentence to the sources section as recommended and deleted it from the types of studies section.

7.    The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
Thank you for highlighting this, the text has now been amended to specify that it is OVID Medline.

8.    The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly.
Thank you for this suggestion we have now amended the manuscript to reflect better the format outlined by the JBI guidance for conducting mixed method systematic reviews.
Competing Interests: No competing interests were disclosed. Close
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Version 2

VERSION 2 PUBLISHED 20 May 2024

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Version 2 (revision) 06 Dec 24	read
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Nathaly Garzón-Orjuela, University College Dublin, Dublin, Ireland
Derek Stewart, Qatar University, Doha, Qatar

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07 Jan 2025 | for Version 2

Nathaly Garzón-Orjuela, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland

3 Views Cite this report Responses(0)

Approved

I have carefully reviewed the second version of this manuscript and find that the authors have adequately addressed all my previous comments and concerns.
The authors have demonstrated a thorough response to feedback, and the updated version meets the standards required for publication. I have no further suggestions for improvement and fully approve this revised manuscript for indexing.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Epidemiology, Systematic review, Meta-analysis, Network meta-analysis, Scoping review, Nutrition, Antibiotic prescription, Health Equity and Data analysis.

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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25 Views

11 Jun 2024 | for Version 1

Derek Stewart, College of Pharmacy, QU Health, Qatar University, Doha, Qatar

25 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Clinical pharmacy; prescribing

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Author Response

06 Dec 2024

Kevin Roche, School of Psychology, University of Galway, Galway, Ireland

Response to Reviewer 2

Thank you very much for the thorough review of our protocol. We greatly appreciate the time that you have taken with this, and we feel that by incorporating your recommendations and suggestions that it has improved the manuscript and made the protocol more robust. We have addressed your points below and within the main body of the text.

Abstract
Specific comments
1.Background – the terms ‘primary care’ and ‘general practice’ are both used. Is this intended?
Our intention here is that when discussing ‘primary care’ we include other prescribing healthcare professionals e.g. pharmacists, advanced nurse practitioners, prescribing public health or practice nurses working in non-secondary care settings could be included. When we refer to ‘general practice’ we are specifically referring to General Practitioners or General Practice registrars (trainees). Due to the very strict word count allowed for an abstract by HRB-OPEN it was not possible to specify this in the abstract. We clarify this in the last two sentences of the third paragraph of the introduction section, Page 4.

2. More importantly, while the title refers to ‘antimicrobials’, this has changed in the background to ‘antibiotics’. These are not the same and must be corrected and standardized throughout.
Thank you for highlighting this, we have changed this per your recommendation.

3. The aim of the review is rather vague and needs to be much more specific in terms of the PICO elements.
We agree, however as above due to the 300-word limit on abstracts for HRB-OPEN it was not possible to provide that level of detail in the abstract.

4. Methods – need to update the search date to the date of the search and not February 2024.
Thank you this has now been updated in both sources section and the study status section.

5. ‘Group-based’ is not defined. See above relating to PICO and the specific elements which are still unclear. The method does not include the appropriate focus on data extraction and quality assessment which should be independently performed for all papers.
Thank you for your comment on this. As we have discussed above the word count limit for the abstract is 300 words maximum and it is not possible to provide a high degree of detail in the abstract.

6. How are the interventions ’coded’?
Please see above reply re: abstract length.

7. Introduction
The authors provide justification for the focus on antibiotics, but this is not sufficiently convincing, and I suggest that the authors consider extending to antimicrobials. Should they retain the antibiotic focus then the title must change accordingly.
Thank you for highlighting this, the title has been amended accordingly.

8. Does inappropriate prescribing not also encompass selection of an inappropriate agent, incorrect duration, dose etc.? The definition provided seems rather limited.
Thank you for pointing out this omission, we have amended our definition to include your suggestions.

9. Clinicians other than doctors can prescribe antimicrobials/antibiotics in many countries hence need to change the focus from just doctors.
Thank you for highlighting this, we recognise that in many countries clinicians other than medical doctors can prescribe antibiotics however as we are using the findings from this review to inform the design and content of a small group educational intervention for Irish General Practice registrars, we have opted to only review the data specific to General Practitioners. We have now included this acknowledgment at the end of the discussion section, page 10.

10. There is no justification provided for the focus on group-based educational interventions rather than other forms of educational intervention (e.g., one-to-one). There is also no coverage of other related evidence syntheses in this field. The authors need to provide greater rationale for this review. See earlier comment on the aim.
Thank you for this feedback. We have now included in the manuscript our rationale that an aim of this systematic review is to inform the design and content of a contextualised intervention for GP registrars. The format of this intervention will be a co-designed theory informed peer led in-person small group-based educational intervention. We have also added additional information on pages 3 & 4 that provides additional rationale.

Objectives
11. Why restrict the review to ‘in person’ interventions? Many interventions could be online etc. The objectives requires some rephrasing and presenting as numbered/bulleted objectives which map to the aim. Identifying components should precede efficacy and effectiveness. Why ‘efficacy’ and ‘potential effectiveness’?
Thank you for this comment, we feel that having taken your other suggestions regarding adjusting the rationale that we have addressed why we are limiting the review to in-person interventions (Page 4). By rephrasing and including your suggested clarifying information in the objectives section we feel that this section is now stronger. Thank you for your helpful insights.

12. What is meant by ‘insights’ and does ‘participants’ include the education provider or patient perspective?
We are using the term ‘insights’ as a hold all label for the qualitative findings. ‘Participants’ will include education provider and we have included this in the manuscript, thank you for highlighting this as including it will help clarify.
However, as we are focusing on interventions aimed at General Practitioners / General Practice registrars we will not be reporting patient perspectives. A patient-oriented scoping review is also being conducted separately by the research team and this will inform the broader programme of work. Please see:
Maher A, Roche K, C Morrissey E et al. Behaviour change interventions addressing antibiotic treatment seeking behaviour for respiratory tract infections in primary care settings: A scoping review protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2024, 7:41 (https://doi.org/10.12688/hrbopenres.13831.1)

Methods
13. The review is appropriately designed in terms of the JBI mixed methods review approach. Excellent to read of detailed stakeholder involvement but why only those with a medical background and what about expert patients? Stakeholder involvement reads more as reviewer involvement.
Thank you. This review is part of a broader multi-faceted programme of work currently underway that does include PPI however as the current review is focused on GPs / GP registrars our interpretation of stakeholder used here is only in the context of the review. We considered our stakeholder involvement for the current review based on the ACTIVE framework (https://training.cochrane.org/involving-people) there are expert patients and patient contributors in the broader research project, and they will have input in the final intervention design that this review will inform.

14. Small group intervention is now more clearly defined. How will these phenomena be operationalized? For example, if the studies do not describe all 3 elements, will they be excluded? These elements do not feature in the data extraction section.
Studies will not be excluded if they do not list or describe the three features that we consider pertinent to small group interventions however at full text screening level we will review and record the degree to which the intervention reports on these. This information will be recorded under the intervention characteristics section.

15. Participants – see earlier comments and suggest that this is extended to any prescriber/prescriber group. All prescribers should be included.
As discussed above an aim of this review is to inform the content and development of an intervention aimed at GP registrars. Currently in Ireland where the intervention is being developed in Primary Care only GPs / GP registrars under supervision can prescribe antibiotics.

16. As before, why exclude non-face-to-face education?
The reason we are excluding non-face-to-face education is that we are aiming to use our findings from this systematic review to inform the content and design of a contextualised intervention for GP registrars. We are only including studies that will help edify the intervention.

17. In this section, the authors are not describing the intervention but more the outcomes. Needs much more detail on how to record the intervention and its components.
Thank you for highlighting this. We have amended the original text based on your feedback.

18. Comparator – are studies excluded if no comparator (e.g., qualitative studies).
No, as this is a mixed methods systematic review we will be including quantitative, qualitative and mixed – methods studies providing they are relevant to the phenomenon of interest. We have amended this section following a suggestion from reviewer 1.

19. Outcomes – need to clarify the differences between efficacy and effectiveness studies. Some of the secondary outcomes are measures of intervention process (e.g., content of the material) and are not outcomes.
Thank you for highlighting this for us we have now omitted this section as having considered the feedback from both reviewers and having read further examples of published reviews we feel that it’s inclusion is not warranted for this mixed methods systematic review.

20. Study selection – see earlier comments. In addition, while the abstract states 20% second review, this is now 25%.
Thank you for spotting this, we have amended the manuscript.

21. Data extraction – needs emphasis on the specific intervention, components etc.
Thank you for highlighting this. We have added greater detail to the data extraction section that we feel addresses your suggestion.

22. This is the first mention of facilitators and barriers. I suggest that this section is mapped to the review objectives (same for the synthesis section).
Thank you for this very valid and helpful point. We have now added this to the objectives, as per your suggestion and clarified that we are also including content from intervention providers if it is reported.

23. Data synthesis requires more detail – who is involved, quality assurance etc.
Thank you for this suggestion. We have added more detail to the data synthesis section and we feel that it now answered.

24. Risk of bias – see above. Suggest that all data extraction and quality assessment is 100% independently double reviewed.
This is a very valid suggestion and ideally one we would like to carry out. However as discussed above due to the constraints of the work packages of the programme of work it is not possible. We are using a methodology that has been successfully employed in the conduct of other systematic reviews
e.g. https://doi.org/10.1080/17437199.2023.2185653

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Competing Interests

No competing interests were disclosed.

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25 Views

08 Jun 2024 | for Version 1

Nathaly Garzón-Orjuela, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland

25 Views Cite this report Responses(1)

Approved With Reservations

I am grateful for the opportunity to review this protocol. Upon reviewing the protocol, I have noted the following observations:

The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviors such as video conferencing or online modules, peer comparison.....
The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly

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?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Epidemiology, Systematic review, Meta-analysis, Network meta-analysis, Scoping review, Nutrition, Antibiotic prescription, Health Equity and Data analysis.

Respond to this report

Responses (1)

Author Response

06 Dec 2024

Kevin Roche, School of Psychology, University of Galway, Galway, Ireland

Response to reviewer 1

Thank you for taking the time to review and respond to our systematic review protocol. We have reflected on your feedback and incorporated the suggestions into our revised manuscript. We feel that by incorporating the changes that you have suggested we have made the protocol more robust and greatly appreciate the time you have taken to review it.

1.    The title and objective differ in the size of the group; the title focuses on "small group," while the objective does not specify the size of this group, only mentioning "group-based." This discrepancy should be addressed to ensure clarity.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

2.    The exclusion criteria should define specific characteristics that disqualify a study from being included, not the opposite of the inclusion criteria. They are distinct criteria that help refine the scope of the review and ensure that only the most relevant studies are included. In Table 1, the exclusion criteria for participants should be revised. The current exclusion criterion, "Non-GP prescribers (e.g. Nurses, Pharmacists) working in General Practice / Primary Care settings," is not an exclusion criterion because it refers to a group that will not be included in the first place. Instead, an exclusion criterion for GP participants could be GPs working in an administrative role or AMS committee. The exclusion criteria for the phenomenon of interest should also be reviewed.
Thank you for pointing this out. We have now amended the text in particular the introductory section to clarify our phenomenon of interest and also the rationale for it. We have edited the inclusion criteria to take this feedback into account.

3.    Table 1, in the Phenomenon of Interest section, focuses on "... in-person group," while the text reflects "in-person small group." To maintain consistency, the size or kind of group should be specified.
Thank you for highlighting this, the manuscript has been amended accordingly and all references to “group” now specify small group.

4.    The term "in-person" refers to educational interventions that involve face-to-face interactions?. However, the protocol does not provide justification for excluding virtual or remote groups. If the intention is to only include educational interventions with face-to-face interactions, the protocol should clarify this. Alternatively, if the intention is to include both in-person and virtual/remote groups, the protocol should specify the criteria for including each type.
Thank you for suggesting this, we have now amended the protocol to address this point and have developed this point further in the introduction section.

5.    The comparators need clarification. The term "usual care" is ambiguous. Is it not intervention? Or any other educational interventions focused on antibiotic prescribing behaviours such as video conferencing or online modules, peer comparison.....
Thank you for this point, we have amended the comparators section as per your suggestion to make it more suitable for a mixed methods systematic review.

6.    The sentence "Relevant systematic reviews and meta-analyses will be screened for primary studies that were not identified in the initial searches" should be relocated to the "Searching other resources" section as part of "Sources" as part of examining the reference list for searching additional papers.
Thank you for this suggestion, we have moved this sentence to the sources section as recommended and deleted it from the types of studies section.

7.    The protocol should specify which search engine or platform (e.g., OVID, PUBMED, or EMBASE) will be used to search MEDLINE.
Thank you for highlighting this, the text has now been amended to specify that it is OVID Medline.

8.    The outcome should be more specific. Focusing on the primary outcome reported in the studies included would be more effective, as the measures of efficacy and effectiveness of studies are typically based on their primary outcomes and sample sizes are calculated accordingly.
Thank you for this suggestion we have now amended the manuscript to reflect better the format outlined by the JBI guidance for conducting mixed method systematic reviews.

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Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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The use of small group based educational interventions in General Practice to improve antibiotic prescribing behaviours: a mixed methods systematic review protocol

Abstract

Background

Methods

Discussion

Keywords

Revised Amendments from Version 1

Introduction

Objectives

Methods

Design

Stakeholder involvement

Eligibility

Types of studies

Table 1. Inclusion / exclusion criteria.

Population

Phenomenon of interest

Context

Sources

Search strategy

Data management

Study selection

Data extraction

Data synthesis

Risk of bias

Ethics

Dissemination

Study status

Protocol tracking

Discussion

Data availability

References

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