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Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension
| Reporting guideline provided for? (i.e. exactly what the authors state in the paper) |
Reporting randomised controlled trials (RCTs) of social and psychological interventions. CONSORT-SPI 2018 checklist (Word) CONSORT-SPI 2018 checklist (PDF) |
| Full bibliographic reference | Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; on behalf of the CONSORT-SPI Group. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018;19:407. |
| Language | English |
| PubMed ID | 30060754 |
| Relevant URLs (full-text if available) |
The full-text of the CONSORT-SPI reporting guideline can be accessed at: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2733-1 The CONSORT-SPI group have also developed checklist extensions for: Abstracts CONSORT-SPI 2018 abstract checklist (Word) CONSORT-SPI 2018 abstract checklist (PDF) Cluster trials CONSORT-SPI 2018 checklist for cluster trials (Word) CONSORT-SPI 2018 checklist for cluster trials (PDF) Cluster trial abstracts CONSORT-SPI 2018 checklist for cluster trial abstracts (Word) CONSORT-SPI 2018 checklist for cluster trial abstracts (PDF) |
| Explanation and elaboration papers | Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018;19(1):406. PMID: 30060763 Full-text access at: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2735-z |
| Relevant more generic / specialised reporting guidelines (i.e. main generic guideline or extension to a generic guideline) |
Generic CONSORT 2010 Statement: Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010;152(11):726-32. PMID: 20335313 BMC Medicine. 2010;8:18. PMID: 20334633 BMJ. 2010;340:c332. PMID: 20332509 J Clin Epidemiol. 2010;63(8): 834-40. PMID: 20346629 Lancet. 2010;375(9721):1136 supplementary webappendix Obstet Gynecol. 2010;115(5):1063-70. PMID: 20410783 Open Med. 2010;4(1):60-68. PLoS Med. 2010;7(3): e1000251. PMID: 20352064 Trials. 2010;11:32. PMID: 20334632 Specialised CONSORT Harms: Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, Li T, Mayo-Wilson E, Pham B, Phillips R, Santaguida P, Scherer RW, Gøtzsche PC, Moher D, Ioannidis JPA, Vohra S; CONSORT Harms Group. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials. BMJ. 2023;381:e073725. PMID: 37094878 J Clin Epidemiol. 2023:S0895-4356(23)00090-2. PMID: 37100738 CONSORT Non-inferiority: Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604. PMID: 23268518 CONSORT Cluster: Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. PMID: 22951546 CONSORT Herbal: Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT Statement. Ann Intern Med. 2006;144(5):364-367. PMID: 16520478 CONSORT Non-pharmacological treatment interventions: Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40-47. PMID: 28630973 CONSORT Abstracts: Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1):e20. PMID: 18215107 Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371(9609):281-3. PMID: 18221781 CONSORT Pragmatic Trials: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. PMID: 19001484 STRICTA Controlled trials of acupuncture: MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. PMID: 20543992 CONSORT PRO: Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814-22. PMID: 23443445 CONSORT-CENT: Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT group. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.BMJ. 2015;350:h1738. PMID: 25976398 CONSORT for orthodontic trials: Pandis N, Fleming PS, Hopewell S, Altman DG. The CONSORT Statement: Application within and adaptations for orthodontic trials. Am J Orthod Dentofacial Orthop. 2015;147(6):663-679. PMID: 26038070 TIDieR: Hoffmann T, Glasziou P, Boutron I, Milne R, Perera R, Moher D, Altman D, Barbour V, Macdonald H, Johnston M, Lamb S, Dixon-Woods M, McCulloch P, Wyatt J, Chan A, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. PMID: 24609605 Simulation Research: Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M; International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators. Reporting Guidelines for Health Care Simulation Research: Extensions to the CONSORT and STROBE Statements. Simul Healthc. 2016;11(4):238-248. PMID: 27465839 CONSORT for pilot and feasibility trials: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; on behalf of the PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Stud. 2016;2:64. PMID: 27965879 CONSORT-CHM formulas: Cheng C-W, Wu T-X, Shang H-C, Li Y-P, Altman DG, Moher D, Bian Z-X; for the CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. 2017. Ann Intern Med. Link to full-text. CONSORT for within person randomised trials: Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017;357:j2835. PMID: 28667088 CONSORT Equity: Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P; CONSORT-Equity and Boston Equity Symposium. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ. 2017;359:j5085. PMID: 29170161 Stepped wedge cluster randomised trials: Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. PMID: 30413417 CONSORT for multi-arm parallel-group randomised trials: Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019;321(16):1610-1620. PMID: 31012939 CONSORT 2010 extension to randomised crossover trials: Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019;366:l4378. PMID: 31366597 CENT for TCM: Li J, Hu JY, Zhai JB, Niu JQ, Kwong JSW, Ge L, Li B, Wang Q, Wang XQ, Wei D, Tian JH, Ma B, Yang KH, Dai M, Tian GH, Shang HC; CENT for TCM Working Group. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): Recommendations, explanation and elaboration. Complement Ther Med. 2019;46:180-188. PMID: 31519276 STRICTOC: Zhang X, Tian R, Lam WC, Duan Y, Liu F, Zhao C, Wu T, Shang H, Tang X, Lyu A, Bian Z. Standards for reporting interventions in clinical trials of cupping (STRICTOC): extending the CONSORT statement. Chin Med. 2020;15:10. PMID: 32021646 ACE Statement: Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ. 2020;369:m115. PMID: 32554564 Trials. 2020;21(1):528. PMID: 32546273 CONSORT-AI: Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK; on behalf of the SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension. BMJ 2020;370:m3164. PMID: 32909959 Nat Med. 2020:26(9):1364–1374. PMID: 32908283 Lancet Digital Health. 2020;2(10):e537-e548. PMID: 33328048 CONSORT-ROUTINE: Kwakkenbos L, Imran M, McCall SJ, McCord KA, Fröbert O, Hemkens LG, Zwarenstein M, Relton C, Rice DB, Langan SM, Benchimol EI, Thabane L, Campbell MK, Sampson M, Erlinge D, Verkooijen HM, Moher D, Boutron I, Ravaud P, Nicholl J, Uher R, Sauvé M, Fletcher J, Torgerson D, Gale C, Juszczak E, Thombs BD. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ. 2021;373:n857. PMID: 33926904 CONSORT-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 Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022;328(22):2252-2264. PMID: 36511921 CONSORT-DEFINE: Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Hopewell S, Ursino M, Rantell KR, Calvert M, Lee S, Kightley A, Ashby D, Chan AW, Garrett-Mayer E, Isaacs JD, Golub R, Kholmanskikh O, Richards D, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, Dimairo M, Weir CJ. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. BMJ. 2023;383:e076387. PMID: 37863501 CONSORT Factorial: Kahan BC, Hall SS, Beller EM, Birchenall M, Chan AW, Elbourne D, Little P, Fletcher J, Golub RM, Goulao B, Hopewell S, Islam N, Zwarenstein M, Juszczak E, Montgomery AA. Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2023;330(21):2106-2114. PMID: 38051324 CONSORT-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 reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. BMJ. 2024;386:e078524. PMID: 38981645 |
| Reporting guideline website URL | https://www.spi.ox.ac.uk/research/site/consort-spi/outputs.html |
| Reporting guideline acronym | CONSORT-SPI 2018 |
| Study design | Clinical trials, Experimental studies |
| Clinical area | Behavioural medicine, Psychology |
| Applies to the whole report or to individual sections of the report? | Abstract, Conference paper/abstract, Conflict of interest, Funding, Intervention (exposure), Outcomes (variables), Procedure/Method, Results, Statistical methods and analyses, Study characteristics (participants etc.) |
| Additional information | This reporting guideline also includes a CONSORT extension for abstracts for social and psychological intervention trials (table 3) and a CONSORT extension for cluster randomised trials for social and psychological intervention trials (tables 4 and 5). Read the protocol for the development of the reporting guideline: Montgomery P, Grant S, Hopewell S, Macdonald G, Moher D, Michie S, Mayo-Wilson E. Protocol for CONSORT-SPI: an extension for social and psychological interventions. Implement Sci. 2013;8:99. PMID: 24004579 |
| Selected relevant editorials | Read an editorial about CONSORT-SPI: Grant S; CONSORT-SPI Group. The CONSORT-SPI 2018 extension: a new guideline for reporting social and psychological intervention trials. Addiction. 2018. PMID: 30091280 |
| Record last updated on | July 23, 2024 |