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Guidelines for Inclusion of Patient -Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension
| Reporting guideline provided for? (i.e. exactly what the authors state in the paper) |
Reporting in clinical trial protocols in which patient-reported outcomes (PROs) are a primary or key secondary outcome. |
| Full bibliographic reference | 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. |
| Language | English |
| PubMed ID | 29411037 |
| Relevant URLs (full-text if available) |
The the full-text of this reporting guideline is available at: https://jamanetwork.com/journals/jama/article-abstract/2671472 |
| Explanation and elaboration papers | Calvert M, King M, Mercieca-Bebber R, et al. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open. 2021;11:e045105. doi: 10.1136/bmjopen-2020-045105 |
| Availability in additional languages | The SPIRIT-PRO Extension is available in Japanese (PDF). |
| 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-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-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 SPIRIT-Surrogate: Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Blazeby J, Butcher NJ, Bujkiewicz S, Chan AW, Dawoud D, Offringa M, Ouwens M, Hróbjartssson A, Amstutz A, Bertolaccini L, Bruno VD, Devane D, Faria CDCM, Gilbert PB, Harris R, Lassere M, Marinelli L, Markham S, Powers JH 3rd, Rezaei Y, Richert L, Schwendicke F, Tereshchenko LG, Thoma A, Turan A, Worrall A, Christensen R, Collins GS, Ross JS, Taylor RS, Ciani O. Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration. BMJ. 2024;386:e078525. PMID: 38981624 SPIRIT-iNeurostim: Bresnahan R, Copley S, Eldabe S, Thomson S, North RB, Baranidharan G, Levy RM, Collins GS, Taylor RS, Duarte RV. Reporting guidelines for protocols of randomised controlled trials of implantable neurostimulation devices: the SPIRIT-iNeurostim extension. EClinicalMedicine. 2024;78:102933. PMID: 39610902 |
| Reporting guideline acronym | SPIRIT-PRO |
| Study design | Clinical trials, Experimental studies, Study protocols |
| Applies to the whole report or to individual sections of the report? | Outcomes (variables) |
| Other relevant research (i.e. research regarding the guideline's effectiveness usability, impact etc.) |
Cruz Rivera S, Stephens R, Mercieca-Bebber R, Retzer A, Rutherford C, Price G, Slade A, Aiyegbusi OL, Edge P, Roberts L, Gosden L, Verdi R, Wilson R, Calvert M. 'Give Us The Tools!': development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension. BMJ Open. 2021;11(6):e046450. PMID: 34193492 |
| Record last updated on | December 6, 2024 |