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Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension
| Reporting guideline provided for? (i.e. exactly what the authors state in the paper) |
Reporting outcomes in clinical trial protocols. SPIRIT-Outcomes checklist (for combined completion of SPIRIT 2013 and SPIRIT-Outcomes 2022 items) PDF SPIRIT-Outcomes extension items only checklist (for separate completion of SPIRIT 2013 and SPIRIT-Outcomes 2022 items) PDF |
| Full bibliographic reference | Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension. JAMA. 2022;328(23):2345-2356. |
| Language | English |
| PubMed ID | 36512367 |
| Relevant URLs (full-text if available) |
Read the full-text of the SPIRIT-Outcomes reporting guideline. Five optional additional items for outcome reporting in trial protocols and/or associated trial documents have also been proposed and these can be found in eTable 6 in the supplementary materials available on the JAMA website. |
| Relevant more generic / specialised reporting guidelines (i.e. main generic guideline or extension to a generic guideline) |
Generic SPIRIT 2013: Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. PMID: 23295957 Specialised SPIRIT-PRO: Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT; and the SPIRIT-PRO Group. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018;319(5):483-494. Link to abstract SPIRIT-TCM: Dai L, Cheng CW, Tian R, Zhong LL, Li YP, Lyu AP, Chan AW, Shang HC, Bian ZX. Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med. 2019;25(1):71-79. PMID: 30484022 SPENT 2019: Porcino AJ, Shamseer L, Chan A-W, Kravitz RL, Orkin A, Punja S, Ravaud P, Schmid CH, Vohra S; on behalf of the SPENT group. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ 2020; 368. Link to full-text. SPIRIT-AI: Rivera SC, Liu X, Chan A-W, Denniston AK, Calvert MJ; on behalf of the SPIRIT-AI and CONSORT-AI Working Group. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension. BMJ. 2020;370:m3210. PMID: 32907797 Nat Med. 2020;26(9):1351–1363. PMID: 32908284 Lancet Digital Health. 2020;2(10):e549-e560. PMID: 33328049 SPIRIT-Path: Kendall TJ, Robinson M, Brierley DJ, Lim SJ, O'Connor DJ, Shaaban AM, Lewis I, Chan AW, Harrison DJ; SPIRIT-Path group. Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extension. Lancet Oncol. 2021;22(10):e435-e445. PMID: 34592193 SPIRIT-DEFINE: Yap C, Rekowski J, Ursino M, Solovyeva O, Patel D, Dimairo M, Weir CJ, Chan AW, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Calvert M, Rantell KR, Lee S, Kightley A, Hopewell S, Ashby D, Garrett-Mayer E, Isaacs J, Golub R, Kholmanskikh O, Richards DP, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, de Bono J. Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance. BMJ. 2023;383:e076386. PMID: 37863491 SPIRIT Factorial: Kahan BC, Hall SS, Beller EM, Birchenall M, Elbourne D, Juszczak E, Little P, Fletcher J, Golub RM, Goulao B, Hopewell S, Islam N, Zwarenstein M, Chan AW, Montgomery AA. Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement. JAMA Netw Open. 2023;6(12):e2346121. PMID: 38051535 |
| Reporting guideline acronym | SPIRIT-Outcomes 2022 |
| Study design | Clinical trials, Experimental studies, Study protocols |
| Applies to the whole report or to individual sections of the report? | Outcomes (variables), Statistical methods and analyses |
| Record last updated on | January 9, 2024 |