Reporting guidelines are “A checklist, flow diagram, or structured text to guide authors in reporting a specific type of research, developed using the explicit methodology.” and it ensures a manuscript that was
- Understand by a reader.
- Replicated by a researcher.
- Used by a doctor to make a clinical decision.
- Included in a systematic review.
Most of the studies are not reporting properly or poor reporting, the cause of poor reporting is,
- Many published articles omit vital information (poor mentioning randomization, blinding, biases)
- Difficult to understand how the research was done.
- Misleading interpretation.
- Selective reporting of methods of findings.
Improving the reproducibility of health research, especially biomedical research is a major challenge. Transparent and accurate reporting is vital to this process; it allows readers to assess the reliability of the findings and repeat or build upon the work of other researchers. So, it is necessary that need specific guidelines for specific designs.
Guidelines related to specific designs
|Diagnostic/Prognostic studies||STARD /TRIPOD|
|Case reports||CARE Extensions|
|Clinical practical guidelines||AGREE/RIGHT|
|Qualitative research||SPQR/ COREQ|
|Animal pre-clinical studies||ARRIVE|
|Quality improvement studies||SQIRE|
|Reliability and agreement studies||COSMIN|
CONSORT GUIDELINES: The CONSORT1 is a protocol developed by a group of researchers. It is intended to improve the reporting of the parallel-group randomized controlled trial (RCT), the purpose of consort is not only to identify problems arising from conducting RCTs but also to report a full, clear manner of results yielded by research. CONSORT statement has 2 components, a 25-item checklist, and a flow diagram to facilitate the quality of research. The checklist provides the author with a solid backbone around which to construct and present an RCT and diagram which is a simple flow diagram showing the enrolment of subjects, their allocation to treatment, disposition status, and how they are analyzed in the trial.
STROBE GUIDELINES: STROBE2 guidelines were created to guide the author to report a high-quality presentation of the conducted observational study but not to act as a validation tool or a framework to conduct the studies. STROBE statement consists of a 22-item checklist, which has 18 items common to cohort, cross-sectional, and case-control studies, and 4 items are specific to each study design.
PRISMA GUIDELINES: PRISMA3–5 Stands for Preferred Reporting Items for Systematic reviews and Meta-analyses. It is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, the PRISMA consists of a 27-item checklist and a 4-phase flow diagram. The checklist is intended to facilitate the preparation and reporting of a robust protocol. Flow diagrams help in visualizing the screening process. It initially records the number of articles found and then makes the selection process transparent by reporting on decisions made at the various stage of the systematic review.
SPIRIT GUIDELINES: SPIRIT6 stands for Standard Protocol Items: Recommendations for Interventional Trials. It is an evidence-based recommendation for the minimum content of a clinical trial protocol. SPIRIT is widely endorsed as an international standard for trial protocols. It provides sufficient detail to enable objectives, study population, interventions, methods, and statistical analyses. Ethical considerations, dissemination plans, and administration of the trial. It has a 33-item checklist that applies to protocols for all clinical trials. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, sponsors, funders, IES/IRB, Peer reviewers, journals, registries, policymakers, regulators, and other key stakeholders.
PRISMA-P GUIDELINES: PRISMA-P7,8 Stands for Preferred Reporting Items for Systematic review and Meta-analyses Protocols. It is intended to guide the development of protocols of systematic reviews and meta-analyses evaluating therapeutic efficacy. PRISMA-P Checklist contains 17 numbered items (26 sub-items) considered to be essential and minimum components of a systematic review or meta-analyses protocol, and a checklist based on elements from the PROSPERO register, PRISMA checklist, SPIRIT checklist items, and standard 2.6 from the institute of medicine standards for Systematic reviews.
STARD GUIDELINES: STARD9,10 Stands for Standards for Reporting Diagnostic accuracy studies, the objective of the STARD initiative is to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD 2015 has 30-item checklists. The objectives of STARD 2015 were to include recent evidence about sources of bias and variability and other issues in complete reporting and to make the STARD list easier to use.
TRIPOD: TRIPOD11 Stands for Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis. TRIPOD developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. TRIPOD statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study.
CARE Guidelines: CARE12,13 Stands for Consensus-based Clinical Case Reporting Guideline Development. The purpose of the guidelines is to facilitate the publication of accurate, complete, and transparent case reports. CARE checklist will provide a framework for writing case reports that can be adapted to include specialty-specific information. It has a 13-item checklist. The care guidelines for case reports help authors to reduce the risk of bias, increase transparency, and provide early signals of what works, for which patients, and under which circumstances.
AGREE on Reporting Checklist: AGREE14 Stands for Appraisal of Guidelines for Research and Evaluation. It is a tool to improve reporting of clinical practice guidelines. AGREEⅡis a widely used for assessing the methodological quality of practice guidelines. AGREE Reporting checklist was comprised of 23 items in 6 domains, and it was intended to improve the comprehensiveness, completeness, and transparency of reporting in practice guidelines.
RIGHT: RIGHT15 Stands for Reporting Items for Practice Guidelines in healthcare. It has a 22-item checklist and an explanation and elaboration statement. The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline.
SPQR: SPQR16 Stands for Standards for Reporting Qualitative Research. The SRQR aims to improve the transparency of all aspects of qualitative research by providing clear standards for reporting qualitative research. These standards will assist authors during manuscript preparation, editors and reviewers in evaluating a manuscript for potential publication, and readers when critically appraising, applying, and synthesizing study findings. SPQR Checklist includes 21 items.
COREQ: COREQ17 Stands for COnsolidated criteria for REporting Qualitative research. It is the only reporting guidance for qualitative research to have received other than isolated endorsement although it applies to only a few of the many qualitative methods in use. The COREQ checklist was developed to promote explicit and comprehensive reporting of interviews and focus groups. The COREQ checklist consists of 32 criteria, with a descriptor to supplement each item.
ARRIVE guidelines: ARRIVE18 (Animal Research: Reporting of In Vivo Experiments) is a checklist of recommendations to improve the reporting of research involving animals – maximizing the quality and reliability of published research, and enabling others to better scrutinize, evaluate and reproduce it. ARRIVE 2.0 has 2 parts ARRIVE essential 10 and recommended set and It provides further information about each of the 21 items in ARRIVE 2.0, including the rationale and supporting evidence for their inclusion in the guidelines, elaboration of details to report, and examples of good reporting from the published literature.
SQUIRE: SQUIRE19 stands for Standards for QUality Improvement Reporting Excellence. The SQUIRE guidelines provide a framework for reporting new knowledge about how to improve healthcare. SQUIRE 2.0 guidelines are revised publication guidelines from a detailed consensus process. It stipulates that reports of interventions to improve the safety, value, or quality of healthcare should explicitly describe how potential ethical concerns were reviewed and addressed in the development and implementation of the intervention. SQUIRE 2.0 has an 18-item checklist.
CHEERS 2022: CHEER 202220 Stands for Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision-making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in the interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods, and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex and without regard to context (such as health care, public health, education, social care, etc). CHEERS 2022 has a 28-item checklist and recommendations for each item.
COSMIN: COSMIN21 Stands for COnsensus-based Standards for the selection of health Measurement Instruments. COSMIN published the book Measurement in Medicine. It provides practical advice, underpinned by theoretical principles, on developing and evaluating measurement instruments in all fields of medicine. The COSMIN checklist is focused on evaluating the methodological quality of studies on the measurement properties of health-related patient-reported outcomes (HR-PROs). COSMIN focuses on HR PROs, because of the complexity of these instruments. These instruments measure constructs that are both multidimensional and not directly measurable. The COSMIN checklist could be considered a measurement instrument itself, measuring the methodological quality of a study on measurement properties. Therefore, the measurement properties of the COSMIN checklist itself should be thoroughly investigated. Only three measurement properties are relevant for the validation of the COSMIN checklist: content validity, construct validity (hypotheses testing), and reliability. The other measurement properties are not relevant or cannot be assessed.
ICMJE Recommendations: The ICMJE recommendations22 is a set of guidelines produced by the International Committee of Medical Journal Editors for standardizing the ethics, preparation, and formatting of manuscripts submitted to biomedical journals for publication and to help authors, editors, and others involved in peer review and biomedical publishing create and distribute accurate, clear, reproducible, unbiased medical journal articles. The recommendations may also provide useful insights into the medical editing and publishing process for the media, patients and their families, and general readers.
Giving enough information in the methods section of your manuscript is very important. To help with reporting your research, there are reporting guidelines available for many different study designs. You should use these guidelines when you are preparing and writing your manuscript, and you may be required to provide a completed version of the checklist when you submit your manuscript. A list full of all the reporting guidelines endorsed you can be found in EQUATOR Network23.
- Consort – Downloads [Internet]. [cited 2022 Sep 9]. Available from: http://www.consort-statement.org/downloads
- STROBE – Strengthening the reporting of observational studies in epidemiology [Internet]. [cited 2022 Sep 9]. Available from: https://www.strobe-statement.org/
- PRISMA [Internet]. [cited 2022 Sep 9]. Available from: https://www.prisma-statement.org//PRISMAStatement/
- PRISMA [Internet]. [cited 2022 Sep 9]. Available from: https://www.prisma-statement.org/PRISMAStatement/Checklist
- PRISMA [Internet]. [cited 2022 Sep 9]. Available from: https://www.prisma-statement.org/PRISMAStatement/FlowDiagram
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200–7.
- Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (prisma-p) 2015: Elaboration and explanation. BMJ (Online). 2015 Jan 2;349.
- Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Revista Espanola de Nutricion Humana y Dietetica. 2016;20(2):148–60.
- Korevaar DA, Cohen JF, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, et al. Updating standards for reporting diagnostic accuracy: the development of STARD 2015. Res Integr Peer Rev. 2016 Dec;1(1).
- Bossuyt PM, Reitsma JB, Bruns DE, Bruns DE, Glasziou PP, Irwig L, et al. STARD 2015: An updated list of essential items for reporting diagnostic accuracy studies1. Radiology. 2015 Dec 1;277(3):826–32.
- Tripod statement [Internet]. [cited 2022 Sep 9]. Available from: https://www.tripod-statement.org/resources/
- CARE Case Report Guidelines [Internet]. [cited 2022 Sep 9]. Available from: https://www.care-statement.org/
- Downloads — CARE Case Report Guidelines [Internet]. [cited 2022 Sep 9]. Available from: https://www.care-statement.org/downloads
- Brouwers MC, Kerkvliet K, Spithof K. The AGREE reporting checklist: A tool to improve reporting of clinical practice guidelines. BMJ (Online). 2016 Mar 8;352.
- Chen Y, Yang K, Marušić A, Qaseem A, Meerpohl JJ, Flottorp S, et al. A reporting tool for practice guidelines in health care: The RIGHT statement. Ann Intern Med. 2017 Jan 17;166(2):128–32.
- O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: A synthesis of recommendations. Academic Medicine [Internet]. 2014 [cited 2022 Sep 10];89(9):1245–51. Available from: https://journals.lww.com/academicmedicine/Fulltext/2014/09000/Standards_for_Reporting_Qualitative_Research__A.21.aspx
- Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care [Internet]. 2007 Dec 1 [cited 2022 Sep 10];19(6):349–57. Available from: https://academic.oup.com/intqhc/article/19/6/349/1791966
- Resources | ARRIVE Guidelines [Internet]. [cited 2022 Sep 10]. Available from: https://arriveguidelines.org/resources
- SQUIRE | SQUIRE 2.0 Guidelines [Internet]. [cited 2022 Sep 10]. Available from: http://www.squire-statement.org/index.cfm?fuseaction=page.viewPage&pageID=471
- ISPOR – Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) [Internet]. [cited 2022 Sep 10]. Available from: https://www.ispor.org/heor-resources/good-practices/article/consolidated-health-economic-evaluation-reporting-standards-2022-cheers-2022-statement-updated-reporting-guidance-for-health-economic-evaluations
- Guideline for Systematic Reviews of Outcome Measurement Instruments • COSMIN [Internet]. [cited 2022 Sep 10]. Available from: https://www.cosmin.nl/tools/guideline-conducting-systematic-review-outcome-measures/
- ICMJE | Recommendations [Internet]. [cited 2022 Sep 10]. Available from: https://www.icmje.org/recommendations/
- The EQUATOR Network | Enhancing the QUAlity and Transparency Of Health Research [Internet]. [cited 2022 Sep 9]. Available from: https://www.equator-network.org/
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