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Reporting guidelines under development

The following guidelines are currently being developed:

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We encourage everyone to submit brief details about their reporting guideline under development for inclusion on the EQUATOR website. This will raise awareness about the development of your guideline and help to prevent duplication. To register your reporting guideline under development please complete our brief registration form (Word document).

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REporting Manualised INterventions for Dissemination and Evaluation (REMINDE) Statement

CONSORT Extension for Social and Psychological Interventions: CONSORT-SPI (registered 30 August 2013)

An official extension of the CONSORT 2010 Statement for reporting randomised controlled trials of social and psychological interventions is currently under development. A Delphi process to generate possible reporting standards for the guideline will take place in Fall 2013. Interested stakeholders should contact the project team to get involved in the development and dissemination of the guideline.

STROBE checklist for conference abstracts

The STROBE Group have recently developed a checklist for conference abstracts.

Consort extension to stepped wedge cluster randomised controlled trials

To develop an extension to the reporting guidelines for parallel cluster trials and produce recommended reporting guidelines for stepped wedge cluster randomised controlled trials.

eMERGe – Meta-ethnography Reporting Guidelines (registered 11 December 2013)

Development of new guidelines for the reporting of meta-ethnography qualitative evidence syntheses.

Reporting Guidelines for IDEAL Prospective Development and Prospective Exploration Studies (registered 31 March 2014)

The IDEAL (Idea, Development, Exploration, Assessment and Long term follow up) framework (1) allows for the phased and sequential development of a new surgical innovation, optimizing patient safety as the evidence-base builds in a controlled and purposeful manner.

These guidelines aim to improve the completeness of reports and protocols for IDEAL Prospective Development Studies (PDS – phase 2a) and Prospective Exploration Studies (PES – phase 2b).

1. McCulloch P, Altman DG, Campbell WB, et al, for the Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374: 1105–12.

Checklist for the conduct and reporting of micro-costing studies in health care (registered 9 June 2014)

CONSORT-equity: Improving the relevance of randomized controlled trials for equity-oriented decisions (registered 23 July 2014)

An official extension of the CONSORT 2010 Statement for reporting equity focused randomised controlled trials is currently under development.

SPIRIT Extension for trials in Child Health: SPIRIT-C (registered 22 September 2014)

An official extension of the SPIRIT 2013 Statement defining standard protocol items for clinical trials in children is currently under development. A Delphi process to generate possible reporting standards for the guideline has taken place in Q2-3 2014. A Consensus meeting was held 15 September 2014.

CONSORT Extension for trials in Child Health: CONSORT-C (registered 22 September 2014)

An official extension of the CONSORT 2010 Statement for reporting randomised controlled trials in children is currently under development. A Delphi process to generate possible reporting standards for the guideline has taken place in 2009-2010. A systematic review of the literature was conducted Q2-3 2014. A Consensus meeting was held 16 September 2014.

Preferred Reporting Items for Systematic reviews and Meta-Analysis – Reporting for Children (PRISMA-C) (registered 6 November 2014)

An official extension of the PRISMA 2009 Statement defining standard reporting items for systematic review in children is currently under development. A Delphi process to generate possible reporting standards for PRISMA-C and a consensus meeting have taken place in 2015; the reports are now being prepared.

Preferred Reporting Items for Systematic reviews and Meta-Analysis – Protocols for Children (PRISMA-PC) (registered 6 November 2014)

An official extension of the PRISMA-P Statement defining standard protocol items for systematic review in children is currently under development. A Delphi process to generate possible reporting standards for PRISMA-PC and a consensus meeting have taken place in 2015; the reports are now being prepared.

Adapting TIDieR checklist for reporting public health, health systems and social and environmental policy interventions (UNTIDieR) (registered 26 March 2015)

Adapting TIDieR (Template for Intervention Description and Replication) checklist for reporting public health, health systems and social and environmental policy interventions with potential to affect population health which do not fit well within the existing TIDieR framework.

Reporting of orthotic (splinting) interventions (registered 6 July 2015)

This guideline is intended as an extension or add-on to other guidelines for specific research designs. It addresses how orthotic interventions should be reported within the context of any given quantitative study design.

Reporting guidelines for implementation research and operational research (registered 12 August 2015)

Implementation research involves increasing access to health products and strategies that are already available and have been shown to work but remain beyond the reach of many of the people who could benefit from them. It is rooted in the identification of practical problems facing disease control programmes and in finding solutions which improve access to health interventions and lead to better health outcomes. Different research methods may be used depending on the type of problem studied.

Operational research uses an existing resource – the data routinely collected by programmes – to provide ways of improving programme operations and thereby delivering more effective, efficient and equitable care. Implementation and operational research are usually carried out in close collaboration between researchers and disease control programme staff.

Reporting of Home Visiting Effectiveness/Efficacy Research (RoHVER) (registered 2 September 2015)

This project aims to develop a comprehensive set of reporting guidelines for home visiting that improve and enhance the accuracy of reporting home visiting intervention evaluations. Specifically, the reporting guidelines focus on: (1) reporting effectiveness and efficacy studies, (2) incorporation of study designs endorsed by the Home Visiting Effectiveness of Evidence (HomVEE), and (3) inclusion of more thorough guidelines for reporting home visiting intervention design and implementation data.

PRISMA-RR 2017: an extension to PRISMA for rapid reviews (registered 4 November 2015)

This reporting guideline will address reporting for rapid reviews, including those with analogous terminology (e.g., rapid evidence synthesis, rapid knowledge synthesis).

  • September 2017 update: stage 1 of the guidance is for rapid reviews that include primary studies. Following completion of stage 1, guidance for rapid reviews that include secondary evidence, such as systematic reviews, will be developed and aligned with the development of the PRIOR reporting guideline (currently under development).
  • Protocol is forthcoming. The reporting guideline will be based on the EQUATOR guidance for developing reporting guidelines (PLoS Med 2010;7(2):e1000217).
  • Contact: Adrienne Stevens, adstevens@ohri.ca

PRISMA-DTA: Checklist for reporting of diagnostic test accuracy systematic reviews (registered 18 November 2015)

The objective is to develop and implement a guideline for reporting diagnostic test accuracy systematic reviews and meta-analyses – Preferred Reporting Items for Systematic reviews and Meta-Analysis of Diagnostic Test Accuracy (PRISMA-DTA).

Instrument for reporting of Planned Endpoints in Clinical Trials (InsPECT) – An evidence and consensus based reporting tool (registered 18 November 2015, update June 2017)

Funded by CIHR Canada, the work to develop a new evidence and consensus based reporting checklist for primary outcomes in clinical trial protocols and reports has started in April 2017. Clinical trialists, evidence end-users including systematic reviewers, and those involved in reporting guidelines development would be major beneficiaries of this checklist. It is the next step forward in current efforts to produce and harmonize transparent and reproducible RCT protocols and reports.

  • Read the project summary (Update – December 2016)
  • Follow us on Twitter: @InsPECT2019
  • Contact: Dr. Martin Offringa, Child Health Evaluation Sciences, The Hospital for SickKids, Canada, martin.offringa@sickkids.ca

SPIRIT Extension for N-of-1 Trial Protocols (SPENT) (registered 18 November 2015)

SPENT will extend the SPIRIT Statement (Standardized Protocol Items: Recommendations for Interventional Trials) to the reporting of individual and series N-of-1 trial protocols.

Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) (registered 18 December 2015)

The objective is to develop a guideline to standardize the reporting of scoping reviews – Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR).

PRISMA-Search: guidelines for reporting systematic review literature searches (registered 17 February 2016)

Patent Landscape Reporting Guidelines (registered 9 June 2016)

We recently conducted a systematic review investigating reporting quality of patent or landscapes in the life sciences that is currently in preparation for submission. The systematic review concluded that articles pertaining to the reporting of patent landscaping were of overall poor quality. Notably, we found a lack of reporting of essential methodological elements with very few manuscripts providing enough information for them to be reproducible. This presents a significant problem as intellectual property (IP) plays a key role within life science research and the information provided in these reviews could very well be used to inform the decisions of academic centres, companies funding and policy. We therefore propose the development of guidelines for the reporting of patent/IP guidelines.

  • Smith JA, Arshad Z, Thomas H, Carr AJ, Brindley DA. Evidence of insufficient quality of reporting in patent landscapes in the life sciences. Nat Biotechnol. 2017;35(3): 210-214. PMID: 28267720
  • Contact: James Smith, james.smith2@kellogg.ox.ac.uk

EMERGE (ESPACOMP Medication Adherence reporting Guidelines) (registered 22 June 2016)

An initiative taken by a working group of ESPACOMP (the European Society for Patient Adherence, COMpliance, and Persistence) to develop guidelines for reporting research on medication adherence building on the ABC taxonomy for medication adherence (Vrijens et al. British Journal of Clinical Pharmacology 2012 PMID: 22486599).

  • For more information about the guidelines, please check the EMERGE Delphi protocol here
  • Contact: Sabina De Geest, PhD (Institute of Nursing Science, University of Basel, Basel, Switzerland & KU Leuven, Leuven, Belgium), sabina.degeest@unibas.ch
  • Website: www.espacomp.eu/emerge

Reporting guideline for randomised controlled trials to discontinue chronic medication (registered 26 July 2016)

The guideline aims to provide items to use in the reporting of randomised controlled trials in which chronic medication is discontinued. The guideline can be used as an addition to the CONSORT statement.

Guideline  for reporting the long term impacts of genocide and war (GESUQ) (registered 1 August 2016)

This guideline is being developed to help researchers to report the long term impact of genocides, wars and mass atrocities on mental health.

The Principles of Evidence-based Reporting in Forensic Medicine (PERFORM) Guidelines (registered 8 August 2016)

The guideline contains international consensus on the minimum items that need to be included in a forensic medical expert opinion and how they should be reported.

Preferred Reporting Items for Systematic Review and Meta-Analyses of traditional Chinese medicine: the PRISMA-TCM Statement (registered 18 August 2016)

The objective is to develop and implement a guideline for reporting systematic reviews and meta-analyses in TCM, as a stand-alone extension to the PRISMA. The guideline contains 1) PRISMA for Chinese herb medicine, and 2) PRISMA for moxibustion.

AGREMA: a guideline for reporting mechanism evaluations in randomised controlled trials (registered 18 August 2016)

Studies investigating causal mechanisms from randomised controlled trials (RCTs) are becoming increasingly common. Despite growing numbers of publications and trialist embedding mechanism evaluations into RCTs, the reporting accuracy and consistency of mechanism studies is suboptimal. The heterogeneity in the reporting of mechanism evaluations stifles systematic reviews, complicates meta-analyses, and limits transparency and replication. The aim of this initiative is to develop a reporting guideline for mechanism evaluations in RCTs.

STITCH-IT: Designing, standardizing and monitoring surgical interventions & co-interventions within randomised controlled trials (registered 22 September 2016)

Guidance to help trials teams design surgical interventions in RCTs – to supplement information from CONSORT-NPT, SPIRIT and TIDieR.

Designing Economic Evaluation Protocols (DEEP) to adhere to CHEERS (registered 7 October 2016)

A guide to designing economic evaluations to adhere to the CHEERS reporting guideline.

Reporting E-Delphi Studies (REDS) in health research: development of a preferred items checklist (registered 26 October 2016)

Adaptive designs CONSORT Extension (ACE) (registered 4 November 2016)

The aim is to develop reporting guidance to cover randomised trials that are designed using an adaptive design. This will encompass studies investigating the efficacy and effectiveness of investigative interventions on humans using either frequentist or Bayesian approach; phases 2, 2/3, and 3.

Guideline for Reporting Environmental Epidemiology aNalyses (GREEN) (registered 20 December 2016)

This guideline will encompass studies that report on association between environmental exposures and health outcomes.

Preferred Reporting Items for Overviews of Reviews (PRIOR) (registered 4 January 2017)

This guideline will address reporting of overviews of reviews (overviews). Overviews are increasingly popular knowledge synthesis products that compile data from multiple systematic reviews to provide a single synthesis of relevant evidence for decision-making. We intend to focus the guideline on reporting overviews of healthcare interventions.

Standardized Protocol Items: Recommendations for Observational Studies (SPIROS) (registered 7 February 2017)

Narrative synthesis of quantitative data on effects of interventions (registered 20 February 2017)

This guideline aims to provide improved guidance on the conduct and reporting for systematic reviews of the effects of interventions where the findings are based on a narrative synthesis of quantitative data.

SUCCEED/SUCCÈS: Standards for reporting trials assessing the impact of scaling up interventions of evidence based practices (registered 3 March 2017)

This proposed reporting guideline is born out of our work in the field of implementing large scale evidence based practices. We are currently involved in 3 systematic reviews of scaling up trials, one that we lead (see Effective interventions for scaling up evidence-based practices in primary care: a systematic review https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016041461) and the needs of policy makers in Canada. As director of the knowledge translation component of the CIHR FRQS MSSS Quebec SPOR SUPPORT unit (http://unitesoutiensrapqc.ca/composantes/application-des-connaissances/), we have been asked by policy makers to provide evidence of effective scaling up intervention. However, up to this point we observed very poor reporting. As concluded in one of our reports, “there are still many gaps in the science of scaling up in real-world health care settings”. These gaps are hampering policy makers as well as system managers, to ensure that the vast majority can benefit from the favourable impact of EBP. Canada is perceived as a country of perpetual pilot projects and there is a mounting frustration of not getting the return on investment of the billions of dollars spent on research in this country. The scaling-up of evidence-based practice (EBP) is a relatively new emerging concept in health. Although there is no definitive agreed upon definition, the World Health Organization defines it as deliberate efforts to increase the impact of successfully tested health innovations (EBP) so as to benefit more people and to foster policy and programme development on a lasting basis. Yet, there is a persistent failure to scale up EBPs, especially in high-income countries. Our ongoing systematic review on effective strategies for scaling up EBP in primary care, identified 25 studies. We observed the following gaps in knowledge: a) poor reporting; b) lack of a clear measure of the scaling up outcome (i.e., a measure of coverage with a numerator – the number of units covered by the EBP and a denominator – total number of units targeted); c) unclear distinction between the EBP and the strategies used to scale up the EBP; d) lack of rigorous studies from high income countries; d) poor representation of primary care clinical contexts; e) little assessment of potential harms; and f) absence of patients and public engagement in designing the scaling up strategies. Therefore, we would like to address the lack of a specific reporting guidelines on scaling up trials.

Reporting recommendations for psychometric investigations of patient reported outcome measures (registered 4 April 2017)

This guideline will cover all studies exploring any psychometric property of a patient reported outcome measure.

CONSORT Extension for Trials Conducted in Existing Data Structures (registered 27 April 2017, updated 6 October 2017)

The objective of the proposed project is to develop a consensus driven guideline to improve the reporting of trials conducted in existing data structures, including researcher-generated cohorts, registries, electronic health records, and administrative databases. This will be done as an extension of the Consolidated Standards of Reporting Trials (CONSORT) for trials conducted in existing data structures.

DEVELOPTOOLS (registered 21 June 2017)

This reporting guideline addresses the development of tools such as medical devices, physical assistive devices, eHealth and mHealth applications, patient decision aids, and other tools developed for patients to use.

CONSORT extension for cluster randomised crossover trials (registered 23 June 2017)

This reporting guideline is being developed for cluster randomised crossover trials (CRXO). CRXO trials involve random assignment of groups of individuals (clusters) to a sequence of interventions, where each cluster receives each intervention in a separate period of time. A formal consensus process will be undertaken to refine and agree upon reporting items. Methodologists, trialists and statisticians will be engaged in this process. The development of the reporting guideline is funded through an Australian National Health and Medical Research Council project grant.

  • Research to establish reporting practices in cluster randomised crossover trials has been published in the following article: Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality. Trials. 2016; 17(1):575. PMID: 27923384
  • Contact: Joanne McKenzie, (joanne.mckenzie@monash.edu) or Andrew Forbes (andrew.forbes@monash.edu).

INDEX – Intervention Development Reporting Guideline (registered 5 July 2017)

The Index reporting guideline aims to improve the quality and completeness of reporting different approaches to intervention development.

CONSORT statement: extension to multi-arm parallel RCTs (registered 6 July 2017)

Multi-arm trials that use a parallel group design but have three or more groups are relatively common. The quality and emphasis of the reporting of multi-arm trials varies greatly, making judgements and interpretation difficult. Whilst almost all the elements of the CONSORT Statement apply equally to multi-arm trials some elements need adaptation, and in some cases additional issues need to be discussed.

This document presents an extension to the 2010 version of the CONSORT Statement for reporting multi-arm trials, with a view to facilitating the reporting of such trials. The CONSORT extension for multi-arm trials extends ten items on the CONSORT 2010 checklist and provides examples of good reporting and an evidence-based rationale for the importance of each extension item.

CONSORT for Factorial Design RCTs (registered 18 September 2017)

Extension to CONSORT for trials where participants are simultaneously randomised to more than one research question.

Standards for Reporting of Digital Health Education Intervention Trials (STEDI) (registered 6 October 2017)

Digital health education is an umbrella term encompassing a broad spectrum of educational interventions characterised by their technological contents, learning objectives/outcomes, measurement tools, learning approaches and delivery settings used for health. These interventions, although varying greatly in content and quality, are widely evaluated in randomised controlled trials (RCTs).

Reporting Items for Public Version of Guidelines: RIGHT-PVG (registered 1 November 2017)

  1. To identify and describe currently published literature on the reporting of patient versions of guidelines.
  2. To develop essential reporting items for public, including patient, versions of guidelines for healthcare.
  3. To identify the characteristics of high-quality PVGs.

 

When guideline development is completed and the guideline is published we will remove it from this list and include it in our database of reporting guidelines.

Please do let us know about relevant projects; it will avoid duplication of the process and might also help you to find new collaborators. To register your reporting guideline under development please complete our brief registration form (Word document).

 

Page last updated on: 20 November 2017

 

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