Health Research Reporting Guidelines, Study Execution Manuals, Critical Appraisal, Risk of Bias, & Non-reporting Biases

Health research reporting guidelines are designed to improve the reporting of health research. They are not designed to assess study execution although you may find issues if the author is clear and transparent. An author who faithfully follows a reporting guideline will include elements such as descriptions of protocol deviations with rationale as well as data for variables not specified in the protocol and statistical analyses not specified in the protocol.

Reporting guidelines consist of 4 parts:

• A checklist of elements that should be included in each section of the paper;
• A flowchart or flow diagram;
• The Explanation & Elaboration (E&E) document which explains why each element is included in a reporting guideline and provides examples of best practices for reporting each element;
• Guideline extensions which expand on a particular aspect of the study methodology (such as a more complete of the intervention) or expands on the description based on the subject of the study (Chinese acupuncture).

Why create a protocol?

Many publishers require evidence of a written protocol prior to acceptance of a manuscript. But it is more than that:

"The written protocol can contribute to overall study quality through a variety of routes, several of which come immediately to mind: (1) by enhancing the scientific integrity of the research, (2) by prescribing and initiating the study documentation process, (3) by increasing the efficiency of the total work effort, and (4) by serving as a communication link." 

Ott M. G. (1991). Importance of the study protocol in epidemiologic research. Journal of occupational medicine, 33(12), 1236–1239. 

Isn't registering a study enough?

Registration of a research study, regardless of the type-- clinical trial, systematic review, observational study, etc.-- does not provide the level of detail needed to replicate the study or examine for risk of bias post-publication. Were pre-specified methods followed during the execution of the study, thereby reducing some potential risk of bias? Were there study deviations? Were outcomes switched? Readers cannot fully assess studies without knowing the original intent AND the study execution.

The study below examined a random sample of 439 PROSPERO records from 2018 and compared them against the PRISMA-P checklist for completeness of reporting. They found that <50% of the records from PROSPERO fully reported their intended methods to the extent required from a PRISMA-P checklist.

Booth A, Mitchell AS, Mott A, James S, Cockayne S, Gascoyne S, McDaid C. An assessment of the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P. F1000Res. 2020 Jul 27;9:773. doi: 10.12688/f1000research.25181.2. PMID: 32850123; PMCID: PMC7431973.

Protocol reporting guidelines

Trials: The SPIRIT Group

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. PMID: 23295957; PMCID: PMC5114123.

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. PMID: 23303884; PMCID: PMC3541470.

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Systematic reviews: PRISMA-P

• Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015 Jan 1;4(1):1. doi: 10.1186/2046-4053-4-1. PMID: 25554246; PMCID: PMC4320440.

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Scoping reviews: Best practice guidance

• Peters MDJ, Godfrey C, McInerney P, Khalil H, Larsen P, Marnie C, Pollock D, Tricco AC, Munn Z. Best practice guidance and reporting items for the development of scoping review protocols. JBI Evid Synth. 2022 Apr 1;20(4):953-968. doi: 10.11124/JBIES-21-00242. PMID: 35102103.

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Other published protocol reporting guidelines: EQUATOR Network

• Search the EQUATOR Network for protocol reporting guidelines

CONSORT (Consolidated Standards of Reporting Trials) Statement

Produced by: CONSORT

• Provides a history of CONSORT and the most current versions of CONSORT and CONSORT extensions as well as CONSORT translations to other languages.
• NOTE: The TIDieR extension (found at the EQUATOR Network) can be used with CONSORT but is not a publication from CONSORT.
• Developing a protocol? See SPIRIT (below).

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SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement

Produced by: The SPIRIT Group

• Provides a history of SPIRIT and the most current versions of SPIRIT and SPIRIT extensions as well as SPIRIT translations to other languages.

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Other randomized trial reporting guidelines from the EQUATOR Network

Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement

Produced by: US Centers for Disease Control and Prevention (CDC)
Note: Consider adding the TIDieR (Template for Intervention Description and Replication) extension for added details to your intervention

STROBE: STrengthening the Reporting of OBservational studies in Epidemiology

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RECORD (REporting of studies Conducted using Observational Routinely-collected Data)

Produced by: RECORD-statement.org

• REporting of studies Conducted using Observational Routinely-collected Data (RECORD) is an international collaborative which will develop reporting guidelines for studies conducted using routinely-collected health data (such as health administrative data, electronic medical record data, primary care surveillance data, and disease registries).

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Other observational study reporting guidelines from the EQUATOR Network

SQUIRE (Standards for QUality Improvement Reporting Excellence) Statement

Produced by: SQUIRE

• Provides a history of SQUIRE and the most current versions of SQUIRE and SQUIRE extensions as well as SQUIRE translations to other languages.

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Other quality improvement reporting guidelines from the EQUATOR Network

EQUATOR Network

Housed at: The EQUATOR Network

• Enhancing the QUAlity and Transparency Of health Research.
• Clearinghouse for health research reporting guidelines for human research and pre-clinical animal research.

Meridian Network

Housed at: Iowa State University

• Clearinghouse for reporting guidelines related to animal research.

The reporting guidelines and extensions of each site listed below are all included on the EQUATOR Network site.

ARRIVE (Animal Research: Reporting of In Vivo Experiments) Guidelines

Produced by: The National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3R)

• Provides a history of ARRIVE and the most current versions of ARRIVE as well as ARRIVE translations to other languages.

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CONSORT (Consolidated Standards of Reporting Trials) Statement

Produced by: CONSORT

• Provides a history of CONSORT and the most current versions of CONSORT and CONSORT extensions as well as CONSORT translations to other languages.
• NOTE: The TIDieR extension (found at the EQUATOR Network) can be used with CONSORT but is not a publication from CONSORT.
• Developing a protocol? See SPIRIT.

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COSMIN Checklists for Assessing Study Qualities

Stands for: COnsensus-based Standards for the selection of health Measurement INstruments
Additional information: About the initiative

• Scroll down to view the COSMIN Reporting Guideline for studies on measurement properties

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PRISMA (Preferred reporting Items for Systematic Reviews and Meta-Analyses) Statement

Produced by: Ottawa Hospital Research Institute, University of Oxford, and Monash University

• Provides a history of PRISMA and the most current versions of PRISMA and PRISMA extensions (including PRISMA-P for protocols) as well as PRISMA translations to other languages.

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SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement

Produced by: The SPIRIT Group

• Provides a history of SPIRIT and the most current versions of SPIRIT and SPIRIT extensions as well as SPIRIT translations to other languages.

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SQUIRE (Standards for QUality Improvement Reporting Excellence) Statement

Produced by: SQUIRE

• Provides a history of SQUIRE and the most current versions of SQUIRE and SQUIRE extensions as well as SQUIRE translations to other languages.

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RECORD (REporting of studies Conducted using Observational Routinely-collected Data)

Produced by: RECORD-statement.org

• REporting of studies Conducted using Observational Routinely-collected Data (RECORD) is an international collaborative which will develop reporting guidelines for studies conducted using routinely-collected health data (such as health administrative data, electronic medical record data, primary care surveillance data, and disease registries).

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STROBE: STrengthening the Reporting of OBservational studies in Epidemiology