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:
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.
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.
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.
Systematic reviews: PRISMA-P
Scoping reviews: Best practice guidance
Other published protocol reporting guidelines: EQUATOR Network
Produced by: Ottawa Hospital Research Institute, University of Oxford, and Monash University
Produced by: CONSORT
Produced by: The SPIRIT Group
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
Produced by: RECORD-statement.org
Produced by: SQUIRE
Housed at: The EQUATOR Network
Housed at: Iowa State University
The reporting guidelines and extensions of each site listed below are all included on the EQUATOR Network site.
Produced by: The National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3R)
Produced by: CONSORT
Stands for: COnsensus-based Standards for the selection of health Measurement INstruments
Additional information: About the initiative
Produced by: Ottawa Hospital Research Institute, University of Oxford, and Monash University
Produced by: The SPIRIT Group
Produced by: SQUIRE
Produced by: RECORD-statement.org