Enhancing the QUAlity and Transparency Of health Research

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Reporting guidelines under development for other study designs

Reporting guidelines under development for other study designs or clinical areas:

(year of registration in brackets)

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

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

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

Reporting of orthotic (splinting) interventions (2015)

Designing Economic Evaluation Protocols (DEEP) to adhere to CHEERS (2016)

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

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

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

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

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

Checklist for Reporting In-vitro Studies – CRIS Statement (2017)

DEVELOPTOOLS (2017)

Intervention Development Reporting Guideline (INDEX(2017)

Reporting Items for Public Version of Guidelines (RIGHT-PVG) (2017)

Reporting recommendations for psychometric investigation of patient reported outcome measures (2017)

DevelOpment of Curricula: Tools for Reporting INnovations in Education (DOCTRINE) (2018)

Strengthening transparent Reporting of reseArch on uNfinished nursing CARE (RANCARE(2018)

Consensus Reporting Items for Research in Primary Care (CRISP) (2018)

CHecklist for conversation Analysis reporTing (CHAT) (2018)

REporting Design Research: proposed checklist for reporting on health research involving human centred design (REDR) (2018)

RIGHT for Acupuncture (2018)

ARRIVE for Acupuncture (2018)

BIAS: Transparent reporting of biomedical image analysis challenges (2019)

Reporting Guidelines for Public Health Non-Communicable Diseases Modelling Studies (2019)

METRIC – METhodological Review reportIng Checklist (2019)

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

A protocol for this guideline was published in 2016: PMID 27707687, full text here.

 

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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 (1,2) 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. PMID: 19782876
2. Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2018. PMID: 29697448

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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.

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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.

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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.

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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.

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

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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.

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

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

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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.


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Checklist for Reporting In-vitro Studies – CRIS Statement (registered 29 November 2017, updated November 19, 2018)

CRIS statement is a checklist for uniform reporting across in-vitro studies involving dental materials. CRIS will also help in conducting effective systematic reviews and meta-analyses of specific topics, thus bringing out the best evidence. It includes sections that were not previously reported in in-vitro studies such as sample size calculation, sample preparation and handling, randomisation and blinded assessment and improved reporting of statistical methods and results. This checklist aims to promote transparency, reproducibility, validity and completeness while reporting in-vitro studies involving dental materials.

The group plans to publish the reporting guideline around February 2019.

A website has been already created, with the description of the core group, the chronology of activities and publications, here: www.cris-statement.org.

 


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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.

 

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

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

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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.

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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.

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DevelOpment of Curricula: Tools for Reporting INnovations in Education (DOCTRINE) (registered 16 March 2018)

We are developing a reporting checklist for curriculum development in health professions education. The purpose of this checklist would be to ensure that prospective authors report all essential elements of an educational project to allow future readers to replicate their work. Our review of other reporting checklists in the EQUATOR network shows that the checklists are specific to certain content areas (such as evidence-based practice or team-based learning), whereas our checklist would be generalizable to any health professions educator describing their curriculum as an educational innovation.

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Strengthening transparent Reporting of reseArch on uNfinished nursing CARE (RANCARE) (registered 5 April 2018)

Development of a guideline to strengthen transparent and comprehensive reporting of quantitative measurement of unfinished nursing care (also known as missed care, implicit rationing of care, care left undone, tasks left undone). Embedded in the EU-COST Action 15208 (www.rancare-action.eu). This guideline should be considered in addition to the guideline specified for the underlying study’s design (e.g. STROBE).

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Consensus Reporting Items for Research in Primary Care (CRISP) (registered 28 August 2018)

The CRISP working group is an international, interprofessional, interdisciplinary team working to improve the reporting of primary care research. Globally, there are no guidelines on the reporting of primary care research. There are specific factors related to primary care research and research translation that warrant guidance in reporting. We will perform a needs assessment to identify common and important areas for improvement in reporting of primary care research. Based upon this review, we will propose either extensions of existing guidelines (one or more) or a new guideline. We plan to use a transparent, explicit, iterative group process to develop guidelines that will be useful across the many methods, populations and settings where primary care research is performed, reported and applied.

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CHecklist for conversation Analysis reporTing (CHAT) (registered 29 August 2018)

The scope of this checklist is to enable researchers to assess quality of conversation analytic studies. It can be used to:
(1) assess the quality of reporting, therefore facilitating systematic review and synthesis
(2) provide clear guidelines for authors to ensure that results are presented in a standardised way which maximises their external applicability

This checklist is being developed via the Delphi Consensus process, in collaboration with experts in the field of conversation analysis.

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REporting Design Research: proposed checklist for reporting on health research involving human centred design (REDR) (registered 4 October 2018)

Publications reporting on health interventions or other health research that involves human centred design or design thinking often omit detailed information related to methodology, ethical considerations, and evaluation details. These omissions make it difficult to assess, review, and catalogue such research across disciplines of health and biomedicine. This dearth of information in a research area that is increasingly funded by public agencies, and carried out by and with health stakeholders, presents a problem in that it hinders the ability for building an evidence base, inhibits the opportunity to diffuse innovations, and reduces dissemination of critically important information back to the public. Many issues have resulted in this absence, including barriers of disseminating interdisciplinary research in public health and biomedical journals, lack of incentive for organizations conducting such work to publish it in the scholarly literature (many of whom exist in the private or non-academic sectors), unfamiliarity of the wider health community with the process of research grounded in design, and a lack of rigorous guidance appropriate for scholarly work in this field. The proposed draft set of guidelines is intended to support researchers and practitioners with reporting on the planning, writing, reviewing, and interpretation of research that has used human centred design or design thinking. A draft checklist is intended to serve as a jumping off point for collaborative development of conclusive guidelines that would represent a thorough overview of consensus-based best-practices for utilising design in research to improve health outcomes. Without more frequent reporting and documenting of transparent and evaluable design-based practices in the scholarly literature, such research will not fulfil its potential to complement existing approaches and take further the goal of global health equity. Draft guidance would provide an initial step in a consensus-building process for development of a more definitive set of guidelines for conduct and review of health research using design.

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RIGHT for Acupuncture – An Extension of the RIGHT Statement for Clinical Practice Guidelines on Acupuncture (registered 26 October 2018)

In 2017, the International Standard for Reporting Items for practice Guideline in HealThcare (RIGHT) statement was published to enhance transparency and clarity in the process of developing clinical practice guidelines. Although there was a reporting checklist for health care guidelines, there were some barriers in their applicability to acupuncture due to its specificity in terms of manipulations, locations and channels compared to other health care interventions. It is necessary to standardize the reporting checklist for clinical practice guidelines on acupuncture.

This reporting guideline will be prepared as an extended version of the RIGHT, which has the following advantages: 1) To provide regulations for guideline developers; 2) To obtain more precise and clear guidelines for readers and clinical practitioners; and 3) To evaluate the reporting quality of clinical practice guidelines on acupuncture and improve the transparency of research reports for editors and reviewers

The study design will refer to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, modified as appropriate. A literature review will be conducted, and an international multidisciplinary team, including a Development Group, a Delphi Panellists Group and an Advisory Group, will be established. Three rounds of modified Delphi surveys, face-to-face consensus meetings, consultations with advisors, pilot tests of the draft list of reports and promotion of the checklist are designed. The group plans to update the reporting guideline regularly.

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ARRIVE for Acupuncture – An extension of the ARRIVE Statement for Animal Research on Acupuncture (registered 21 November 2018)

In June 2010, “Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research” was published on PLOS BIOLOGY by Carol Kilkenny and has received considerable attention. Although it offered a reporting checklist for animal pre-clinical studies, there were some barriers in their applicability to acupuncture due to its specificity in terms of rationales, details of manipulation, the operation locations and different strength of evidence compared to other health care interventions. Several studies stated that the reporting quality of animal research on acupuncture is poor. It is necessary to standardise the reporting guideline for animal research as an extended version of the ARRIVE guidelines, which has the following advantages: 1) To provide regulations for animal research developers; 2) To obtain more precise and clear guidelines for readers and experimental researchers; and 3) To evaluate the reporting quality of animal research on acupuncture and improve the transparency of research reports for editors and reviewers.

The group will develop the study design according to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, modified as appropriate. They will establish an international multidisciplinary group including clinical practitioners, acupuncturists, researchers of reporting guidelines on acupuncture, clinical epidemiologists and statisticians. The research team consists of three groups: the Development Group, the Delphi Panellists Group and the Advisor Group. They are currently performing a literature review to systematic review the reporting guidelines of acupuncture and case reports of acupuncture published on peer-review articles. Then they will conduct three rounds of modified Delphi surveys, a face-to-face consensus meeting, consultations with advisers, pilot tests of the draft list of reports and promotion of the checklist.

The group plans to publish the study protocol in a peer-review paper soon, and the reporting guideline on December 2021.

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BIAS: Transparent reporting of biomedical image analysis challenges (registered 23 January 2019)

The number of biomedical image analysis challenges organised per year is steadily increasing. These international competitions have the purpose of benchmarking algorithms on common data sets, typically to identify the best method for a given problem. Recent research, however, revealed “that common practice related to challenge reporting is poor and does not allow for adequate interpretation and reproducibility of results”. To address the discrepancy between the impact of challenges and the quality (control), the Biomedical Image Analysis ChallengeS (BIAS) initiative is developing a set of recommendations for the reporting of challenges. The BIAS statement aims to improve the transparency of the reporting of a biomedical image analysis challenge regardless of field of application, image modality or algorithm category assessed.

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Reporting Guidelines for Public Health Non-Communicable Diseases Modelling Studies (registered on 28 January 2019)

Public health non-communicable diseases (NCD) modelling studies are concerned with quantifying the health impact of changes in risk factors for NCDs without directly measuring health impact. They include both health impacts models and futures models. Health impact modelling estimates the impact of changes in risk factors that relate to scenarios (e.g. policy goals), arise from interventions (e.g. policies, regulatory initiatives) or arise from public health preventative programmes (either single or multi-component programmes). The interventions or programmes being studied operate by affecting wider socio-economic determinants, environmental, behavioural or medical risk factors for NCDs. Futures models estimate the future burden of disease based on changes in risk factors. These studies include, as a direct or intermediate input to the model, changing one or more risk factors for one or more NCDs within a population according to a specified scenario or intervention. They model change in exposures through to at least one NCD specific health outcome and/or to a general measure of health outcome (e.g. quality adjusted life years, all-cause mortality).

The Reporting Guidelines for Public Health Non-Communicable Diseases Modelling Studies should apply to all public health models concerned with quantifying the relationship between a risk factor and health (i.e. health impact models or futures models). Models that focus on describing disease transmission (e.g. infectious disease modelling, social contagion) will be out of scope. The World Health Organization (WHO) definition of non-communicable diseases, which recognises the five major NCDs are cardiovascular diseases, diabetes, chronic respiratory diseases, cancer and mental health conditions, will be used in the development of this guideline.

The group is producing these guidelines, in part, in response to a call by the Medical Research Council in the UK (https://www.mrc.ac.uk/funding/how-we-fund-research/highlight-notices/reporting-guidelines-for-ncd-public-health-modelling-studies/). An initial consultation was taken to agree about the scope of the guidelines and establish an network of participants to support their development globally. The group will follow the five-step process outlined by EQUATOR: literature review; online consensus Delphi; expert consensus meeting (face-to-face); writing of guidelines by small committee; dissemination.

The group is currently seeking funding to undertake the full work, and plans to start the systematic review in September 2019, with a view to publishing the guidelines in 2021. They plan to publish this computer-based modelling reporting guideline, as an open access document, in the Summer/Autumn of 2021.

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METRIC – METhodological Review reportIng Checklist – guidelines for reporting methodological reviews in health research (registered 25 February 2019)

Methodological reviews (MR) are an efficient way of assessing research methods and summarising methodological issues in the conduct and reporting of health research. As part of the ongoing development of this concept and the most appropriate nomenclature, the group has established a working definition for MRs as “studies that appraise the design, conduct, analysis and reporting of other studies”. As such, MRs are seen as highly informative because they allow researchers to generate empirical evidence on the quality, completeness and accuracy of reporting; document the variety of methods used in health research studies; investigate adherence to guidelines; assess approaches to analyses; demonstrate changes in reporting over time; determine consistency between abstracts/trial registries and published articles, and many other issues. Despite an increase in their development and usage, there is limited published guidance on the conduct and reporting of MRs. The current body of literature shows wide inconsistencies in MR nomenclature and methodology. The aim of this guideline is to standardise the nomenclature and reporting of MRs in the context of health research. Based on consensus by expert stakeholders, this guideline and accompanying statement will highlight the necessary methodological features that should be included for designing and reporting high quality MRs.

The development of this guideline started on November, 2017 as follows:

Phase I – Literature Review: Conduct a full scoping review to identify and describe MRs, and report on current methods, summarise the variety of questions being addressed, and develop a preliminary conceptual framework for MRs;

Phase II – Delphi Study & Face-to-Face Consensus Meeting: Establish a working group of expert stakeholders (e.g. methodologists, epidemiologists, biostatisticians, journals, guideline groups) to validate and refine the conceptual framework for MR nomenclature and methodology;

Phase III – Publication and Dissemination: Incorporate expert feedback from the consensus meeting to finalise the MR guideline as a checklist. This document will include the consensus statement and outline standardised criteria for appropriate MR terminology, methodology and reporting. The group intends to publish the reporting guideline as an open access document on May 2021.

 

Page last updated on 25 of February 2019