Reporting guidelines under development for observational studies
Observational studies or STROBE extensions and case reports or CARE extensions
(year of development in brackets)
CARE for Acupuncture (2018)
STROBE-pregnancy outcomes (2020)
STROBE-Equity extension (2021)
Trial Emulations (2021)
Guideline for Reporting Environmental Epidemiology aNalyses (GREEN) (registered 20 December 2016, updated 2 November 2021)
This guideline will encompass studies that report on the association between environmental exposures and health outcomes. The group informs they reviewed the literature and are now seeking partnerships to develop a Delphi process.
- Contact: Laurie Chan, firstname.lastname@example.org
Standardized Protocol Items: Recommendations for Observational Studies (SPIROS) (registered 7 February 2017)
The guidelines aim to define a comprehensive set of standard protocol items for observational studies, and by doing so facilitates and encourages researchers to prepare a study protocol of sufficient quality, prior to data collection.
- Read the protocol at the OSF register or the JMIR journal
- Contact: Maurice Zeegers, email@example.com
Framework for Enhanced Reporting of Interrupted Time Series (FERITS) (registered 22 May 2018)
Reporting guidelines for interrupted time-series studies. These are generally applied for the evaluation of public health interventions.
- Contact: James Lopez Bernal, firstname.lastname@example.org
Outcome-based and observational metrics in surgical studies conducted in Lower-Middle Income Countries (LMICs).
- Key papers preceding the development of these guidelines
(1) Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Mérisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015;386(9993):569-624. PMID: 25924834
(2) Pauyo T, Debas HT, Kyamanywa P, Kushner AL, Jani PG, Lavy C, Dakermandji M, Ambrose H, Khwaja K, Razek T, Deckelbaum DL. Systematic Review of Surgical Literature from Resource-Limited Countries: Developing Strategies for Success. World J Surg. 2015;39(9):2173-81. PMID: 26037025
- Contact: Max Denning, email@example.com
This guideline is being developed by researchers at the Centre for Health Services Studies, University of Kent, to improve the quality and completeness of reporting for Social Prescribing programmes. Social prescribing provides a non-medical referral option to improve health and wellbeing. Referrals can be to a range of programmes from befriending schemes, volunteering opportunities, supported education, arts, physical activity, as well as support with employment or legal advice.
Different Social Prescribing models have evolved across England reflecting local needs, service provider expertise and commissioning contracts. Consequently, models vary greatly in terms of aims of the service, delivery partners, referral pathways, staffing, and service user outcomes making it difficult to identify features of a successful model, for whom social prescribing benefits, and under what circumstances.
SPoRTIER will provide a standardised useable template to capture contextual details on different programmes and how these programmes are being implemented to aid understanding of how social prescribing contributes to changes in health and wellbeing.
Development of SPoRTIER is based on the EQUATOR Network methodological framework for developing reporting guidelines.
- Contact: Sarah Hotham, S.Hotham@kent.ac.uk
There has been an exponential increase in studies applying metagenomic diagnostics, such as 16S PCR and deep-sequencing. The aim of this extension is to adapt the STROBE statement to be more applicable to these types of diagnostics and to ensure transparency in publications on the same.
There will be a broad focus on metagenomics, and appendices on 1) Neurological infections, 2) Antimicrobial Resistance and 3) the Gut Microbiome.
PREHOSPITAL-CARE is a consensus-based guideline under development for publishing pre-hospital case reports. It will be an extension to the CAse REport (CARE) clinical case reporting guideline.
Currently, case reports published on pre-hospital care rarely follow the CARE guideline. The quality of these publications is highly variable. The aim of the PREHOSPITAL-CARE guideline is to improve the quality of pre-hospital care case reports. In January 2021, the authors published a protocol for the project.
- Website: https://prehospital-care.org
- Protocol publication: https://ajp.paramedics.org/index.php/ajp/article/view/885
- Contact: James Pearce, firstname.lastname@example.org
Case reports are still an important source to provide evidence on acupuncture to clinicians and researchers. They can better present the real situation of clinical practice, reflect the individualized treatment characteristics of acupuncture treatment, and inherit the experience of prominent traditional medicine doctors.
CARE is a reporting guideline for case reports. The aim of the CARE for Acupuncture project is to develop an extension of CARE focused on acupuncture areas, which can enhance the transparency and quality of case reports on acupuncture.
The study design will refer to the methodology recommended by the EQUATOR Network, modified as appropriate. A literature review will be conducted, and an international multidisciplinary team is established, including a Development Group, a Delphi Panellists Group and an Advisory Group. From 1st October 2018, the group started a literature search and draft the item checklists. 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 under development. The group plans to update the reporting guideline regularly. The group intends to publish the reporting guideline in 2019, as an open-access document.
- Institution: Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University
- Contact: Yuting Duan, at email@example.com
STROBE for TCM – Reporting Guideline for observational studies on Traditional Chinese Medicine (formerly Chinese Herbal Medicine Formulas) (Registered on 29 July 2019 2019)
Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine interventions. The group aims to develop an extension of STROBE focused on CHM, to enhance the transparency and quality of observational studies on CHM, and following the methodology recommended by the EQUATOR Network.
The development of STROBE for CHM started on 1st July 2019, with a literature review to draft the checklist items. The group will establish an international multidisciplinary team, including a Development Group, a Delphi Panellists Group, and an Advisory Group, and run 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.
September 2019 Update: please note that the reporting guideline development group originally planned to focus this guideline on Chinese herbal medicine (CHM) but following a literature review broadened the scope to cover traditional Chinese medicine (TCM). The title of this reporting guideline under development has therefore been revised in order to reflect this change.
August 2020 Update: the group informs they finished a systematic review on the quality of reporting of cohort, case-control and cross-sectional studies on TCM, to be published soon. They plan to contact the original STROBE authors for comments and suggestions before drafting the initial checklist.
The group plans to publish the reporting guideline as an open-access document on December 2022.
- Professor Zhaoxiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: firstname.lastname@example.org
STORMS – Strengthening The Organising and Reporting of Microbiome Studies (Registered on 22 October 2019)
The group from the Department of Epidemiology and Biostatistics, City University of New York School of Public Health, is preparing a guideline for the reporting of epidemiological studies of the human microbiome. These studies typically address microbiome diversity, richness, and composition across categories of exposure, disease, or other phenotypes. Individual taxa of bacteria that are differentially abundant between groups are usually identified. They are typically observational, although experimental human microbiome studies are possible.
The project began in June 2019 with a systematic review of microbiome literature. A working group of bioinformaticians, epidemiologists, biostatisticians, and graduate students with an interest and expertise in the human microbiome was convened. an initial draft of guidelines was drafted. Working group members then tested the guidelines by reviewing recent microbiome articles using the guidelines. Revisions were made based on the ensuing discussion. The checklist is currently in the second set of pilot testing and revisions.
The group prepared a draft of the guidelines and accompanying paper and plan to pre-publish it on bioRxiv by the end of 2019, with a formal publication as an open-access article in 2020.
- Contact: Chloe Mirzayi, City University of New York School of Public Health, Department of Epidemiology and Biostatistics, Institute for Implementation Science in Population Health, Waldron Lab, Chloe.email@example.com
RULER – Rasch Reporting Guideline for Rehabilitation Research (registered on 22 July 2020)
The purpose of this guideline is to provide consistent guidance for reporting observational studies using psychometric techniques that specifically apply the Rasch Measurement (RM) Theory in a rehabilitation context. The six psychometric domains of the framework guiding this work are 1) content validity, 2) structural validity, 3) external validity, 4) consequential validity, 5) reproducibility and reliability, and 6) practical application and clinical implementation.
The task force members who are contributing to the development of this RM Reporting guideline are all members of the American Congress of Rehabilitation Medicine (ACRM)’s Measurement Networking Group (MNG). The Rasch Measurement Taskforce group was formed, with two co-chairs, and seven members. The task force is meeting monthly from November 2018 to August 2020. This website presents the timeline of planned and finished activities by the group.
- Contacts: Ann Van de Winckel (University of Minnesota) and Trudy Mallinson (The George Washington University). Emails: firstname.lastname@example.org and email@example.com
MEASURE Statement – Medical Education Assessment Studies Uniform REporting statement – A reporting guideline for validity investigation studies (registered on 10 September 2020)
The objective of this working group is to develop a reporting guideline for studies investigating the validity in medical education tests. The reporting guideline will cover all types assessment tools (i.e. checklists, rating scales and simulator metrics) for health professional education (i.e. doctors, dentists, medical students, nurses, midwives, radiology assistants).
The international steering committee has conducted and published a literature review on the subject, to ascertain the need for a reporting guideline. The group plans to conduct a three-round Delphi study to reach consensus on the checklist items. They plan to publish the reporting guideline in early 2021, if possible as an open-access paper. They are also setting a website for the tool.
- Contact: Fleming Bjerrum (Copenhagen Academy for Medical Education and Simulation, Capital Region of Denmark). E-mail: firstname.lastname@example.org
CEDRIC-HIV – ChEcklist for studies of Drug ResIstanCe in HIV (registered on 22 September 2020)
Heterogeneous and inadequate data reporting on HIV drug resistance across countries and populations challenge adequate monitoring of the problem and prevalence estimations and management strategies. The authors are working on a checklist designed for the reporting of studies on the prevalence of pretreatment HIV drug resistance. They conducted a systematic review to determine the need for a reporting guideline and the results informed the second phase of the study. They plan a survey on authors about their opinions on the essential items to be reported in future studies, they will create a list of potential items and a subset of 20 respondents will be selected to take part in focus groups to reach consensus and finalise wording. The group plans to finish the work on June 2021 and publish the reporting guideline as an open-access paper.
- Contact: Lawrence Mbuagbaw and Michael Cristian Garcia, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. E-mails: email@example.com and firstname.lastname@example.org
STROBE-pregnancy outcomes (registered on 27 November 2020)
This guideline will relate to observational studies that report measures of maternal, fetal, and neonatal outcomes, for example, cohort studies examining exposures during pregnancy and subsequent outcomes. An extension to the STROBE reporting guideline is necessary to capture the complexity of perinatal studies, enabling assessment of data plausibility and completeness. The guideline is needed to ensure appropriate reporting of multiple (and competing) outcomes with a clear description of populations included, definitions used and analytical methods applied.
The executive group developing this extension of the STROBE reporting guideline has already finished a review on the quality of reporting of perinatal outcomes and data in the literature and plans to conduct a Delphi exercise in the second quarter of 2021. Consensus meetings will be held in the third quarter, and the development of the statement and piloting at the end of 2021. The group plans to publish the reporting guideline extension in 2022, as an open-access document.
- Contact: Sarah Stock, Usher Institute, University of Edinburgh. E-mail: email@example.com
Health inequities can go frequently unreported in observational studies. This international group of scientists, educators, decision-makers, ethicists, funders, and patients, using an integrated knowledge translation approach, proposes to develop an extension to the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) guideline to deal specifically with these disparities. The project will embed a parallel stream focused on evidence related to Indigenous research. After assessing available guidance for reporting health equity in observational studies and assessing current reporting, they plan to seek international feedback, then conduct an evidence and consensus-driven process to develop a reporting guideline. The project started in January 2021. A series of empirical studies are planned, followed by a consensus meeting, with the final reporting guideline and statement expected in 2024.
- Canadian Institutes of Health Research
- Campbell and Cochrane equity methods group website
- OSF project registration
Contact: Vivian Welch, Bruyère Research Institute, Ottawa, Ontario, Canada. E-mail: firstname.lastname@example.org
STROBE-Vision – an extension of the STROBE statement (registered on 23 February 2021)
This reporting guideline aims to adopt and extend the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) reporting guideline focusing on observational studies on human vision. Specifically, the reporting guideline under development aims to encourage the comprehensive reporting of surveys on population-based vision impairment prevalence, outlining the risks of bias concerning this type of study and recommending reporting items on prevalence estimates and meta-analyses, to permit their proper assessment. The need for a reporting guideline was made clear from the last WHO World Report on Vision (2019), the Lancet Global Health Commission on Global Eye Health (2021) and the Vision Loss Expert Group and the Global Burden of Disease Study (2021).
Ethics committee approval was obtained for this project from the London School of Hygiene and Tropical Medicine Institutional Review Board (December 2019). A two-round Delphi survey will reach a list of agreed items made from the original STROBE items and additional, vision-related ones. Panellists will include epidemiologists, statisticians, journal editors, Cochrane editors, vision impairment and eye disease subject matter experts, guideline developers, and representatives of non-governmental organisations.
The group plans to publish the reporting guideline as an open-access document in 2021.
- Contact: Dr Tasanee Braithwaite, School of Life course, Sciences and School of Immunology and Microbial Sciences, Kings College London, UK; and The Medical Eye Unit, Guy’s and St Thomas’ NHS Foundation Trust, London. E-mail: email@example.com
STROBE-MetEpi – Guidelines for Strengthening the Reporting of Metabolomic Epidemiology Studies (registered 14 May 2021)
The aim of STROBE-MetEpi, an extension of the STROBE reporting guideline, is to define a comprehensive list of protocol items that should be reported in every published metabolomic epidemiology study. The guideline will include reporting standards for both the metabolomic aspects of a study (sample collection, sample storage, profiling platforms quality control, etc.) and the epidemiological aspects (study design, study population, data processing, statistical analyses etc.). It will include observational and diagnostic and prognostic studies.
Experts recruited from across the field of metabolomic epidemiology representing broad diversity in experience and expertise, including epidemiologists, chemists, and computational biologists, are collaborating in the project. The writing team plans to conduct several meetings and literature review to reach a consensus on a checklist of items, that they intend to publish together with an elaboration and explanation document, in an open-access format by 2022.
- Contact: Rachel S. Kelly, Channing Division of Network Medicine, Brigham and Women’s Hospital and Harvard Medical School. E-mail: firstname.lastname@example.org
Trial Emulations (registered 4 November 2021)
In situations where randomised controlled trials (RCTs) are not feasible or ethical, observational studies can emulate a “target trial” to inform decision-making. However, the lack of consistency in the reporting of target trial emulations, usually cohort and case-control studies makes it difficult to benchmark their results against RCTs.
The authors of this reporting guideline on trial emulations are working on a six-phase project that will first establish executive and advisory groups, review the literature, perform a Delphi exercise and a consensus meeting and then publish a reporting guideline with an explanation and elaboration document, as open-access publications. The project started in February 2021 and is planned to be completed in early 2024.
- Contact: Dr Hopin Lee, Centre for Statistics in Medicine (CSM), University of Oxford. E-mail: email@example.com
CARR – CAse Report for Radiology Statement (registered 6 December 2021)
This reporting guideline will be tailored to case reports in radiology or the description of an unusual form of a common disease using radiological images. The project developers believe that the existing reporting guideline for case reports (the CARE Statement) needs an extension focused on radiology, to be used by radiologists, clinicians, journal editors and others. The new guideline will eliminate items that are not applicable for case reports in diagnostic imaging (such as therapeutic interventions) and add items that are lacking in CARE.
A multidisciplinary team of experts will discuss and generate a list of initial items based on CARE and conduct two to three rounds of Delphi exercise to finish the list. The authors have declared they have contacted experts from the original CARE reporting guideline to participate in the working group. They plan to publish the reporting guideline, as an open-access document, in December 2022.
- Contact: Mengshu Wang, Evidence-Based Medicine Centre, School of Basic Medical Sciences, Lanzhou University, China. E-mail: firstname.lastname@example.org
READUS-PV – The Reporting of A Disproportionality analysis for drUg Safety signal detection using spontaneously reported adverse events in PharmacoVigilance (registered 7 March 2022)
The aim of this reporting guideline is to define a list of items mandatory to understand the methods used in studies using disproportionality analyses to evaluate “signals” of potential new adverse drug reactions in pharmacovigilance. According to the authors, this type of analysis allows quantifying the degree to which a drug–adverse event combination is reported as compared to the expected in the absence of any association between the drug and the event. The authors plan a literature review and a Delphi process to inform the checklist to be conducted in 2022. They plan to publish the reporting guideline in 2023.
- Contact: Charles Khouri, Grenoble Alpes University Hospital. E-mail: email@example.com
Page last updated on 7 March 2022