Interventions to improve adherence to reporting guidelines in health research: a scoping review protocol

Abstract

Introduction

There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions.

Methods and analysis

Our review will follow the Joanna Briggs Institute scoping review methods manual. We will search for relevant studies in MEDLINE, EMBASE and Cochrane Library databases. Moreover, we will carry out lateral searches from the reference lists of the included studies, as well as from the lists of articles citing the included ones. One reviewer will screen the full list, which will be randomly split into two halves and independently screened by the other two reviewers. Two reviewers will perform data extraction independently. Discrepancies will be solved through discussion. In addition, this search strategy will be supplemented by a grey literature search. The interventions found will be classified as assessed or suggested, as well as according to different criteria, in relation to their target (journal policies, journal editors, authors, reviewers, funders, ethical boards or others) or the research stage at which they are performed (design, conducting, reporting or peer review). Descriptive statistical analysis will be performed.

Ethics and dissemination

A paper summarising the findings from this review will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding and a broader perspective on how the problem of adhering better to reporting guidelines has been tackled so far. This could be a major first step towards developing future strategies to improve compliance with reporting guidelines in health research.

Strengths and limitations of this study.

• Results from this scoping review will contribute to a broader perspective on how the problem of improving compliance with reporting guidelines has been addressed in the published literature thus far.

• This scoping review is part of a larger project whose ultimate goal is to explore what strategies to improve adherence to reporting guidelines could be implemented and formally assessed.

• A potential limitation could be the small number of eligible articles in the literature.

• As this is a scoping review, the quality of the evidence will not be assessed.

Introduction

Reporting guidelines have been available since the inception of the Consolidated Standards for Reporting Trials (CONSORT) statement (1996), which provided a minimum set of recommendations for reporting randomised trials. From that time, different reporting guidelines for different study types, data and clinical areas have been developed. In general, these guidelines provide advice on how to report research methods and findings.¹

Although the vast majority of reporting guidelines have not yet been assessed as to whether they help improve the reporting of research,² for some of them, such as CONSORT, it has been shown that they may enhance the completeness of reporting.^{3 4}

Dozens of systematic reviews have explored the extent of adherence to different reporting guidelines in some areas of health research.^5–9 Samaan et al ¹⁰ went one step further and performed a systematic review of systematic reviews assessing adherence to reporting guidelines. As they considered a broad range of clinical areas and study designs since the creation of the CONSORT Statement, their results provided a global picture of compliance with reporting guidelines in health research. The authors determined that, although some studies reported acceptable overall reporting quality and stated that it has improved since the introduction of the CONSORT Statement, most of the reviews (43 of 50, 86%) concluded that more improvement is needed, or that the reporting quality was inadequate, poor, medium or suboptimal. For this reason, the authors outlined some recommendations to enhance adherence to reporting guidelines and encouraged action to develop strategies to improve the current state of completeness of reporting.

In recent years, different initiatives aiming to improve adherence to reporting guidelines have been proposed, and some of them have already been evaluated. For example, writing aid tools such as WebCONSORT¹¹ have been developed and assessed, the influence of statistician involvement on quality of reporting has been evaluated¹² and different studies have investigated the effect of explicitly endorsing reporting guidelines on completeness of reporting.3 4 13 14 While some of these actions have not been shown to have a benefit,^{11 12} others report better but still suboptimal levels of reporting.4 5 13 14 Therefore, further actions have to be taken to enhance the current levels of compliance with reporting guidelines.

As mentioned, several reviews have analysed the quality of reporting in different clinical areas and for different studies,^5–10 but no scoping review investigating what actions have been taken or suggested in order to improve compliance with reporting guidelines has been performed so far. Given the low levels of completeness of reporting in health research observed¹⁰ and the need of taking further actions to mitigate this problem, we consider that performing such a scoping review is warranted.

The goal of this scoping review is to identify interventions aiming to improve adherence to reporting guidelines in health research. More specifically, in addition to quantify the effect of those already evaluated, our aim is to gather ideas suggested in the literature as possible interventions that could be implemented in the future.

Methods

Our research objectives will be addressed using established scoping review methodology. Since we aim to provide a wide overview of this field,¹⁵ and map the key concepts underpinning this research area and the main sources and types of evidence available, we consider that performing a scoping review is the most suitable approach.¹⁶ This protocol will follow the methodology manual published by the Joanna Briggs Institute for scoping reviews.¹⁷

Scoping review questions

We aim to answer the following questions:

1. What interventions to improve adherence to reporting guidelines in health research have been evaluated?

2. What actions to improve adherence to reporting guidelines have been suggested in the literature?

3. For each intervention found in the questions 1 and 2 above, 

   1. What was the target? We will consider the following possible targets: journal policies, journal editors, authors, reviewers, funders, ethical boards or others.
   2. What research stages does it affect? We will consider the following possible research stages: design, conducting, reporting, and peer review.
   3. In which healthcare area was it evaluated or suggested?
   4. What was the rationale behind it?
   5. In cases where it was evaluated,

      • How was it evaluated?
      • What reporting guidelines does it consider?
      • What was the effect on adherence to the reporting guidelines mentioned above?

Inclusion criteria

We will include:

1. Studies evaluating interventions aiming to improve the adherence to reporting guidelines in health research, irrespective of study design.

2. Commentaries, editorials, letters and studies containing ideas or suggestions of interventions that can be implemented.

The reporting guidelines considered will be those shown in the EQUATOR (Enhancing the QUAlity and Transparency Of Health Research) Network website¹ as ‘Reporting Guidelines for main study types’ (see table 1). In addition, we will also include Quality of Reporting of Meta-analyses for systematic reviews, as it was the precursor of PRISMA.

Table 1.

Description of the acronyms and full names of the reporting guidelines shown in the EQUATOR website as ‘Reporting Guidelines for main study types’

Acronym	Full name
CONSORT	Consolidated Standards of Reporting Trials
STROBE	Strengthening the Reporting of Observational Studies in Epidemiology
PRISMA	Preferred Reporting Items for Systematic Reviews and Meta-Analyses
SRQR	Standards for Reporting Qualitative Research
COREQ	Consolidated criteria for Reporting Qualitative research
STARD	Standard Protocol Items: Recommendations for Interventional Trials
TRIPOD	Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis
SQUIRE	Standards for Quality Improvement Reporting Excellence
CHEERS	Consolidated Health Economic Evaluation Reporting Standards
SPIRIT	Standard Protocol Items: Recommendations for Interventional Trials
PRISMA-P	Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols
CARE	Case Report
AGREE	Appraisal of Guidelines, Research and Evaluation
ARRIVE	Animal Research: Reporting In Vivo Experiments
RIGHT	Reporting Tool for Practice Guidelines in Health Care

EQUATOR, Enhancing the QUAlity and Transparency Of Health Research.

Exclusion criteria

We will consider the following languages: English, French, German, Catalan and Spanish. Publications not written in any of those languages will be excluded.

Search strategy

We will search MEDLINE (via PubMed), EMBASE and Cochrane Library databases for relevant articles. The search will be limited to articles published between 1 January 1996 and 31 March 2017, given that the CONSORT Statement is considered the first reporting guideline in biomedical research and it was published in 1996. The search strategy has been developed with the help of a librarian of the Barcelona Tech. Table 2 and 3 show the detailed search terms for MEDLINE and EMBASE. The search terms for Cochrane Library are analogue to those used for EMBASE.

Table 2.

Search terms for MEDLINE (from 1 January 1996 to 31 March 2017) via PubMed

Steps	Search terms
S1	impact* [tw]
S2	improv* [tw]
S3	enhanc* [tw]
S4	boost* [tw]
S5	increas* [tw]
S6	influenc* [tw]
S7	effect [tw]
S8	S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7
S9	compliance [tw]
S10	adherence [tw]
S11	completeness [tw]
S12	quality of reporting [tw]
S13	reporting quality [tw]
S14	S9 OR S10 OR S11 OR S12 OR S 13
S15	Consolidated [tw] Standards [tw] Reporting [tw] Trials [tw] OR CONSORT[tw]
S16	Strengthening [tw] Reporting [tw] Observational [tw] Studies [tw] Epidemiology[tw] OR STROBE[tw]
S17	Preferred [tw] Reporting [tw] Items [tw] Systematic [tw] reviews [tw] Meta-Analyses [tw] OR PRISMA[tw]
S18	Standards [tw] Reporting [tw] Qualitative Research[tw] OR SRQR[tw]
S19	Consolidated [tw] Criteria [tw] Reporting [tw] Qualitative [tw] Research[tw] OR COREQ[tw]
S20	Standard [tw] Protocol [tw] Items [tw] Recommendations [tw] Interventional [tw] Trials[tw] OR STARD[tw]
S21	Transparent [tw] Reporting [tw] multivariable [tw] prediction [tw] model [tw] Individual [tw] Prognosis [tw] Diagnosis[tw] OR TRIPOD[tw]
S22	Standards [tw] QUality [tw] Improvement [tw] Reporting [tw] Excellence[tw] OR SQUIRE[tw]
S23	Consolidated [tw] Health [tw] Economic [tw] Evaluation [tw] Reporting [tw] Standards[tw] OR CHEERS[tw]
S24	Standard [tw] Protocol [tw] Items [tw] Recommendations [tw] Interventional [tw] Trials[tw] OR SPIRIT[tw]
S25	Preferred [tw] Reporting [tw] Items [tw] Systematic [tw] Review [tw] Meta-Analysis [tw] Protocols[tw] OR PRISMA-P[tw]
S26	Quality [tw] Reporting [tw] Meta-analyses[tw] OR QUOROM[tw]
S27	Case [tw] Report [tw] AND CARE[tw]
S28	Appraisal [tw] Guidelines [tw] Research [tw] Evaluation[tw] AND AGREE[tw]
S29	Animal [tw] Research [tw] Reporting [tw] Vivo [tw] Experiments[tw] AND ARRIVE[tw]
S30	Reporting [tw] Tool [tw] Practice [tw] Guidelines [tw] Health [tw] Care[tw] AND RIGHT[tw]
S31	S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR S23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30
S32	S8 AND S14 AND S31
S33	S32 AND ‘1996/01/01’[PDAT]: ‘2017/03/31’[PDAT]

Table 3.

Search terms for EMBASE (from 1 January 1996 to 31 March 2017)

Steps	Search terms
S1	impact*:ti,ab
S2	improv*:ti,ab
S3	enhanc*:ti,ab
S4	boost*:ti,ab
S5	increas*:ti,ab
S6	influenc*:ti,ab
S7	effect:ti,ab
S8	S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7
S9	compliance:ti,ab
S10	adherence:ti,ab
S11	completeness:ti,ab
S12	‘quality of reporting’:ti,ab
S13	‘reporting quality’:ti,ab
S14	S9 OR S10 OR S11 OR S12 OR S 13
S15	‘Consolidated Standards of Reporting Trials’:ti,ab OR CONSORT:ti,ab
S16	‘Strengthening the Reporting of Observational Studies in Epidemiology’:ti,ab OR STROBE:ti,ab
S17	‘Preferred Reporting Items for Systematic reviews and Meta-Analyses’:ti,ab OR PRISMA:ti,ab
S18	‘Standards for Reporting Qualitative Research’:ti,ab OR SRQR:ti,ab
S19	‘Consolidated criteria for Reporting Qualitative research’:ti,ab OR COREQ:ti,ab
S20	‘Standard Protocol Items: Recommendations for Interventional Trials’:ti,ab OR STARD:ti,ab
S21	‘Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis’:ti,ab OR TRIPOD:ti,ab
S22	‘Standards for Quality Improvement Reporting Excellence’:ti,ab OR SQUIRE:ti,ab
S23	‘Consolidated Health Economic Evaluation Reporting Standards’:ti,ab OR CHEERS:ti,ab
S24	‘Standard Protocol Items: Recommendations for Interventional Trials’:ti,ab OR SPIRIT:ti,ab
S25	‘Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols’:ti,ab OR PRISMA-P:ti,ab
S26	‘Quality of Reporting of Meta-analysis’:ti,ab OR QUOROM:ti,ab
S27	‘Case Report’:ti,ab AND CARE:ti,ab
S28	‘Appraisal of Guidelines, Research and Evaluation’:ti,ab AND AGREE:ti,ab
S29	‘Animal Research: Reporting In Vivo Experiments’:ti,ab AND ARRIVE:ti,ab
S30	‘Reporting Tool for Practice Guidelines in Health Care’:ti,ab AND RIGHT:ti,ab
S31	S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR S23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30
S32	S8 AND S14 AND S31
S33	S32 AND (1996–2017)/py NOT [31-3-2017]/sd

The retrieved studies will be exported into the reference manager Mendeley, which will be subsequently used to remove the duplicates. One reviewer (DB) will first screen the titles and abstracts for eligibility before reading the full texts, while the other two reviewers (EC and JJK) will be assigned and will also screen the titles and the abstracts of one of the two random halves in which the full list will be divided. This process will be carried out in Mendeley. Second, the reviewers will thoroughly examine the full text for all potentially eligible articles to confirm whether the study should be included or not. One reviewer (DB) will ensure literature saturation by searching the reference lists of included studies, as well as the lists of articles citing them, according to PubMed. Disagreement will be addressed by consensus after discussion, and the third reviewer (EC or JJK) will be consulted if no consensus is reached.

In addition, we will perform a grey literature search, including websites of networks promoting the use of reporting guidelines (ie, EQUATOR Network), organisations that offer resources for reviewers (ie, Publons), work groups of medical journal editors (ie, ICMJE), biomedical journal publishers (ie, BMJ Publishing Group) or funding agencies (ie, NIH). In addition, a non-systematic search in Google Scholar will be performed.

The starting date of the search is 8 May 2017.

Data extraction

The selected articles will be exported into an Excel file, where the data extraction will be performed. Two authors (DB and JJK) will independently extract data as shown below:

1. Publication characteristics: title, year of publication, author, design, country of origin and field of study.

2. Characteristics of the intervention:

   1. Classification as evaluated or suggested.
   2. Target: journal policies, authors, peer reviewers, journal editors, funders, ethical boards or others.
   3. Research stage: design, conducting, reporting or peer review.
   4. Healthcare area where it was evaluated or suggested.
   5. Rationale.
   6. In case that it was evaluated, way of assessment, reporting guidelines considered, and effect of the intervention on adherence to those reporting guidelines.

3. Overall conclusions by the authors.

If further information is needed, we will contact the authors of the included studies. Any disagreement will be solved by discussion.

Synthesis and reporting of results

The interventions found will be first divided in two groups: the ones that have already been evaluated and the ones that have not. For each group, the interventions will be classified according to their target population, as well as to the research stage at which they were performed or suggested. The general characteristics of included studies will be summarised. In addition, for the group of evaluated interventions, we will describe how the authors assessed them, what reporting guidelines they considered and what their effect on adherence to those reporting guidelines was. Descriptive statistical analysis will be performed.

A checklist for reporting scoping reviews, the ‘Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews (PRISMA-ScR)’, is currently under development.¹⁸ However, according to its developers, it is highly unlikely that the checklist will be published before we report the results of the review.

Discussion

The aim of this review is to identify and classify interventions to improve adherence to reporting guidelines. We believe that having a wide picture of how the problem of adhering better to reporting guidelines has been tackled so far, as well as investigating what further actions have been suggested, is critical to facing the problem of improving adherence to reporting guidelines with a broader perspective.

This scoping review is part of a larger project whose ultimate goal is to explore what strategies to improve adherence to reporting guidelines could be implemented and formally assessed. The results of this review could send a message to funders, authors, editors and reviewers about what has already been done to face this critical problem, and about what else could be done from now on. We believe that this review could be a major first step towards developing future strategies to improve adherence to reporting guidelines.