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SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting of n-of-1 trial protocols.
Full bibliographic reference 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.
Language English
PubMed ID 32107202
Relevant URLs
(full-text if available)
The full-text of the SPENT 2019 checklist is available at: https://www.bmj.com/content/368/bmj.m122
Relevant more generic / specialised reporting guidelines
(i.e. main generic guideline or extension to a generic guideline)
Generic
SPIRIT 2013 Statement: 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

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-Outcomes: 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. PMID: 36512367

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 SPENT
Study design Clinical trials, Experimental studies, Study protocols
Applies to the whole report or to individual sections of the report? Protocol-whole report
Additional information Read the SPENT development statement (PDF).
Record last updated on January 9, 2024

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