SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.
| Title: | SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials. |
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| Authors: | Hróbjartsson A; Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark ahrobjartsson@health.sdu.dk.; Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.; Boutron I; Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.; Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France.; Hopewell S; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.; Moher D; Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.; Schulz KF; Department of Obstetrics and Gynaecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Collins GS; UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.; Tunn R; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.; Aggarwal R; Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.; Berkwits M; JAMA and the JAMA Network, Chicago, IL, USA.; Berlin JA; Department of Biostatistics and Epidemiology, School of Public Health, Centre for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.; JAMA Network Open, Chicago, IL, USA.; Bhandari N; Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.; Butcher NJ; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.; Campbell MK; Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.; Chidebe RCW; Project PINK BLUE-Health and Psychological Trust Centre, Utako, Abuja, Nigeria.; Department of Sociology and Gerontology and Scripps Gerontology Centre, Miami University, OH, USA.; Elbourne DR; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.; Farmer AJ; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.; Fergusson DA; Ottawa Hospital Research Institute, Ottawa, ON, Canada.; Golub RM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.; Goodman SN; Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.; Hoffmann TC; Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, QLD, Australia.; Ioannidis JPA; Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Centre at Stanford (METRICS), Stanford University, Stanford, CA, USA.; Kahan BC; MRC Clinical Trials Unit at University College London, London, UK.; Knowles RL; University College London, UCL Great Ormond Street Institute of Child Health, London, UK.; Lamb SE; Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.; Lewis S; Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK.; Loder E; The BMJ, BMA House, London, UK.; Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.; Offringa M; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.; Ravaud P; Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.; Richards DP; Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada.; Rockhold FW; Duke Clinical Research Institute, Duke University Medical Centre, Durham, NC, USA.; Schriger DL; Department of Emergency Medicine, University of California, Los Angeles, CA, USA.; Siegfried NL; Mental Health, Alcohol, Substance Use, and Tobacco Research Unit, South African Medical Research Council, Cape Town, South Africa.; Staniszewska S; Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.; Taylor RS; MRC/CSO Social and Public Health Sciences Unit and Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.; Thabane L; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.; St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.; Torgerson DJ; York Trials Unit, Department of Health Sciences, University of York, York, UK.; Vohra S; Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.; White IR; Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Centre at Stanford (METRICS), Stanford University, Stanford, CA, USA.; Chan AW; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada. |
| Source: | BMJ (Clinical research ed.) [BMJ] 2025 Apr 28; Vol. 389, pp. e081660. Date of Electronic Publication: 2025 Apr 28. |
| Publication Type: | Journal Article; Comment |
| Language: | English |
| Journal Info: | Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN: 1756-1833 (Electronic) Linking ISSN: 09598138 NLM ISO Abbreviation: BMJ Subsets: MEDLINE; In Process |
| Imprint Name(s): | Original Publication: London : British Medical Association |
| Competing Interests: | Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Medical Research Council-National Institute for Health and Care Research (MRC-NIHR) for the submitted work. AH, A-WC, SH, IB, KFS, and DM, are members of the SPIRIT-CONSORT Executive Group. AH, AWC, SH, IB, KFS, GSC, DM, MKC, NJB, MO, RST, and SV are involved in the development, update, implementation, and dissemination of several reporting guidelines. GSC is the director of the UK EQUATOR Centre and statistics editor for The BMJ. DM is the director of the Canadian EQUATOR Centre and a member of The BMJ’s regional advisory board for North America. IB is deputy director and PR is director of the French EQUATOR Centre. TCH is director of the Australasian EQUATOR Centre. JPAI is director of the US EQUATOR Centre. RA is president of the World Association of Medical Editors. MKC is chair of the MRC-NIHR: Better Methods Better Research funding panel. RCWC is executive director of Project PINK-BLUE, which receives funding from Roche-Product. AF is director of the UK NIHR Technology Assessment Programme. DPR is a full time employee of Five02 Laboratories, which under contract to Clinical Trials Ontario provides services related to patient and public engagement, and is the volunteer vice president of the Canadian Arthritis Patient Alliance, which receives funding through independent grants from pharmaceutical companies. DLS is associate editor of the Journal of the American Medical Association and receives editing stipends from JAMA and Annals of Emergency Medicine. IRW was supported by the MRC programmes MCUU00004/07 and MCUU00004/09. |
| Comments: | Comment on: BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.. (PMID: 40294953) |
| References: | Trials. 2016 Dec 7;17(1):581. (PMID: 27927219); Stroke. 2006 Jan;37(1):123-8. (PMID: 16322489); Trials. 2016 Feb 19;17:100. (PMID: 26895826); Stat Med. 2009 Nov 30;28(27):3329-46. (PMID: 19739238); J Clin Epidemiol. 2019 Sep;113:11-19. (PMID: 31055176); J Eval Clin Pract. 2018 Feb;24(1):240-253. (PMID: 29076631); BMJ Open. 2020 Aug 26;10(8):e038283. (PMID: 32847919); J Clin Oncol. 2005 May 1;23(13):3112-24. (PMID: 15860871); J Eur Acad Dermatol Venereol. 2022 Feb;36(2):196-212. (PMID: 34661930); Int J Epidemiol. 2014 Aug;43(4):1336-9. (PMID: 24706730); Pediatr Infect Dis J. 2002 Aug;21(8):753-8. (PMID: 12192164); J Clin Epidemiol. 2009 Sep;62(9):967-73. (PMID: 19635403); Trials. 2018 Dec 29;19(1):712. (PMID: 30594227); BMJ. 2018 Feb 13;360:k400. (PMID: 29440066); BMC Med Res Methodol. 2016 Jul 08;16 Suppl 1:77. (PMID: 27410040); BMC Med Res Methodol. 2013 Mar 25;13:50. (PMID: 23530582); PLoS Med. 2016 Jun 28;13(6):e1002046. (PMID: 27352244); CMAJ. 2004 Sep 28;171(7):735-40. (PMID: 15451835); Cochrane Database Syst Rev. 2021 Dec 8;12:MR000051. (PMID: 34878168); BMJ. 2018 Oct 03;363:k3654. (PMID: 30282703); BMC Musculoskelet Disord. 2017 Jul 20;18(1):312. (PMID: 28728580); J Clin Epidemiol. 2019 Sep;113:168-175. (PMID: 31153976); Clin Trials. 2011 Oct;8(5):674-6. (PMID: 22013173); Chin J Integr Med. 2019 Jan;25(1):71-79. (PMID: 30484022); Lancet. 1999 Dec 4;354(9194):1983-8. (PMID: 10622312); BMJ. 2011 Apr 05;342:d1828. (PMID: 21467104); Clin Epidemiol. 2019 Feb 11;11:169-184. (PMID: 30809104); BMJ. 1999 Sep 11;319(7211):703-4. (PMID: 10480833); JAMA. 2018 Feb 6;319(5):483-494. (PMID: 29411037); Med. 2022 May 13;3(5):335-343.e6. (PMID: 35584654); BMJ Open. 2023 Dec 10;13(12):e078645. (PMID: 38072483); N Engl J Med. 2017 Jan 26;376(4):383-391. (PMID: 28121511); N Engl J Med. 2023 Apr 27;388(17):1582-1596. (PMID: 37099341); BMJ. 2024 Jan 23;384:e076316. (PMID: 38262663); J R Soc Med. 2023 Dec;116(12):425-432. (PMID: 37991449); PLoS Med. 2008 Nov 25;5(11):e230. (PMID: 19067481); BMJ. 1996 Nov 16;313(7067):1245-8. (PMID: 8939118); J Clin Epidemiol. 2018 Apr;96:1-11. (PMID: 29288136); JAMA. 2000 Dec 27;284(24):3139-44. (PMID: 11135777); J Clin Epidemiol. 2011 Oct;64(10):1070-5. (PMID: 21474279); J Clin Epidemiol. 2023 Mar;155:48-63. (PMID: 36669708); BMJ. 2016 Oct 3;355:i5078. (PMID: 27697753); JAMA. 2021 Jul 20;326(3):257-265. (PMID: 34152382); BMJ. 2011 Jan 06;342:c7153. (PMID: 21212122); BMJ Open. 2023 Oct 3;13(10):e075570. (PMID: 37788925); BMJ. 2020 Oct 27;371:m3764. (PMID: 33109515); Clin Pharmacol Ther. 2014 Jun;95(6):617-26. (PMID: 24739446); Trials. 2023 Jul 27;24(1):478. (PMID: 37501092); N Engl J Med. 2008 Jan 17;358(3):252-60. (PMID: 18199864); Pharmacopsychiatry. 2023 Sep;56(5):169-181. (PMID: 37506738); BMJ. 2005 Apr 23;330(7497):956-8. (PMID: 15845980); CMAJ. 2009 May 12;180(10):E47-57. (PMID: 19372436); Ther Innov Regul Sci. 2024 May;58(3):539-548. (PMID: 38438658); Clin Trials. 2005;2(3):218-29; discussion 229-32. (PMID: 16279145); J Dent Res. 2018 Jan;97(1):5-13. (PMID: 28813182); Ann Intern Med. 2008 Feb 19;148(4):295-309. (PMID: 18283207); Clin Trials. 2011 Aug;8(4):432-9. (PMID: 21835862); PLoS Med. 2016 Aug 16;13(8):e1002101. (PMID: 27529343); Trials. 2023 Oct 3;24(1):634. (PMID: 37789461); Stat Med. 2024 May 20;43(11):2083-2095. (PMID: 38487976); Res Synth Methods. 2024 Mar;15(2):288-302. (PMID: 38146072); N Engl J Med. 2022 Dec 8;387(23):2138-2149. (PMID: 36342116); BMJ. 2017 Jun 5;357:j2372. (PMID: 28584025); Ther Innov Regul Sci. 2016 Jul;50(4):436-441. (PMID: 30227022); Health Aff (Millwood). 2019 Mar;38(3):359-367. (PMID: 30830822); BMJ Open. 2023 Aug 30;13(8):e068487. (PMID: 37648383); Cochrane Database Syst Rev. 2009 Jan 21;(1):MR000006. (PMID: 19160345); JAMA. 2023 May 16;329(19):1695-1697. (PMID: 37010865); J Clin Epidemiol. 2023 Aug;160:71-82. (PMID: 37356637); Trials. 2008 Jul 31;9:48. (PMID: 18671864); J Clin Epidemiol. 2013 Dec;66(12):1367-75. (PMID: 24075598); J Clin Epidemiol. 2021 May;133:A5-A6. (PMID: 34024414); Lancet. 2008 Jul 19;372(9634):201. (PMID: 18640445); Trials. 2023 May 29;24(1):362. (PMID: 37248499); BMJ Open. 2019 Nov 10;9(11):e026661. (PMID: 31712328); J Clin Epidemiol. 2024 Jan;165:111211. (PMID: 37939743); Am J Trop Med Hyg. 2020 Nov 23;104(2):695-699. (PMID: 33236704); Curr Cardiol Rep. 2014;16(10):531. (PMID: 25135344); Ann Pharmacother. 2008 Nov;42(11):1605-12. (PMID: 18957629); Trials. 2010 Apr 13;11:37. (PMID: 20388211); J R Soc Med. 2023 Nov;116(11):386-394. (PMID: 37975723); Trials. 2019 Feb 28;20(1):150. (PMID: 30819228); Trials. 2022 Dec 14;23(1):1014. (PMID: 36514143); Ann Oncol. 2017 Apr 1;28(4):688-695. (PMID: 28011448); BMJ. 2020 Feb 27;368:m122. (PMID: 32107202); BMJ. 2010 Mar 23;340:c332. (PMID: 20332509); BMC Med. 2015 Sep 15;13:221. (PMID: 26370288); Trials. 2022 Sep 13;23(1):773. (PMID: 36100943); BMJ Open. 2024 Feb 5;14(2):e076455. (PMID: 38316588); Control Clin Trials. 1996 Aug;17(4):285-90; discussion 290-3. (PMID: 8889343); PLoS One. 2023 Jul 27;18(7):e0289038. (PMID: 37498821); Clin Trials. 2004 Feb;1(1):48-59. (PMID: 16281462); Trials. 2020 Oct 28;21(1):898. (PMID: 33115516); J Clin Epidemiol. 2010 Sep;63(9):983-91. (PMID: 20573483); BMJ Open. 2017 Mar 20;7(3):e015276. (PMID: 28320800); Lancet Oncol. 2021 Oct;22(10):e435-e445. (PMID: 34592193); Contemp Clin Trials Commun. 2023 Apr 14;33:101136. (PMID: 37180845); Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000012. (PMID: 17443633); BMJ. 2021 Mar 3;372:n450. (PMID: 33658187); PLoS One. 2012;7(11):e49163. (PMID: 23166608); Lancet. 2020 Mar 7;395(10226):828-838. (PMID: 32145797); Cancer Epidemiol Biomarkers Prev. 2002 Jan;11(1):73-7. (PMID: 11815403); Am J Occup Ther. 2013 Mar-Apr;67(2):146-53. (PMID: 23433268); J R Soc Med. 2017 May;110(5):208-218. (PMID: 28504072); Int J Geriatr Psychiatry. 2009 Sep;24(9):990-1001. (PMID: 19263464); N Engl J Med. 2011 Jul 7;365(1):3-5. (PMID: 21651388); N Engl J Med. 2011 Mar 3;364(9):852-60. (PMID: 21366476); Lancet Glob Health. 2025 Apr;13(4):e759-e768. (PMID: 40155113); N Engl J Med. 2022 Jan 20;386(3):209-219. (PMID: 35045227); Trials. 2009 May 20;10:33. (PMID: 19454041); Stroke. 2001 Apr;32(4):909-16. (PMID: 11283391); Trials. 2011 Jan 12;12:9. (PMID: 21226951); BMJ Open. 2023 Nov 23;13(11):e073470. (PMID: 37996238); Eur J Cancer. 2016 Oct;66:1-8. (PMID: 27500368); BMJ Open. 2023 Oct 9;13(10):e065295. (PMID: 37813539); Lancet. 2003 Mar 22;361(9362):1015-6. (PMID: 12660062); Cochrane Database Syst Rev. 2021 Mar 6;3:MR000032. (PMID: 33675536); J Clin Epidemiol. 2017 Jun;86:39-50. (PMID: 28529187); Lancet. 2014 Jan 11;383(9912):156-65. (PMID: 24411644); J Biomed Inform. 2017 Jul;71:130-142. (PMID: 28499952); Rheumatology (Oxford). 2004 Jun;43(6):704-11. (PMID: 14997006); J Eval Clin Pract. 2013 Aug;19(4):708-12. (PMID: 23648092); Lancet. 2005 Feb 19-25;365(9460):711-22. (PMID: 15721478); J Clin Epidemiol. 2021 Jan;129:114-123. (PMID: 32987162); J Clin Epidemiol. 2024 May;169:111309. (PMID: 38428538); BMJ. 2009 Sep 07;339:b3244. (PMID: 19736281); BMJ Open. 2021 Nov 29;11(11):e056191. (PMID: 34845079); Trials. 2023 Aug 15;24(1):534. (PMID: 37582719); Lancet. 2009 Mar 21;373(9668):992. (PMID: 19304003); Stat Med. 2001 Sep 15-30;20(17-18):2573-83. (PMID: 11523070); Eur J Med Genet. 2016 Jun;59(6-7):295-309. (PMID: 27130428); BMJ Paediatr Open. 2024 Feb 27;8(Suppl 1):. (PMID: 38417919); Trials. 2020 Jun 08;21(1):498. (PMID: 32513289); Ann Intern Med. 2017 Jul 4;167(1):40-47. (PMID: 28630973); Clin Trials. 2016 Apr;13(2):161-8. (PMID: 26400875); J Clin Epidemiol. 2022 Sep;149:45-52. (PMID: 35654268); BMJ. 2004 Feb 21;328(7437):432. (PMID: 14761905); Trials. 2022 Oct 1;23(1):836. (PMID: 36183080); Am J Psychiatry. 2006 Feb;163(2):185-94. (PMID: 16449469); Ther Innov Regul Sci. 2024 May;58(3):483-494. (PMID: 38334868); JAMA. 2012 May 2;307(17):1838-47. (PMID: 22550198); J Clin Epidemiol. 2019 Sep;113:20-27. (PMID: 31055175); BMJ Open. 2022 Jun 8;12(6):e062338. (PMID: 35676006); J Crit Care. 2006 Jun;21(2):229; author reply 229-30. (PMID: 16769475); PLoS Med. 2020 Sep 21;17(9):e1003294. (PMID: 32956344); N Engl J Med. 2006 Mar 16;354(11):1193. (PMID: 16495386); Clin Trials. 2009 Dec;6(6):597-609. (PMID: 19933718); Trials. 2023 May 6;24(1):313. (PMID: 37149623); BMC Med Res Methodol. 2017 Dec 6;17(1):162. (PMID: 29207961); Trials. 2019 Mar 15;20(1):169. (PMID: 30876434); JAMA Netw Open. 2020 Jul 1;3(7):e2011127. (PMID: 32697320); Cochrane Database Syst Rev. 2023 Mar 6;3:MR000055. (PMID: 36877132); J Med Ethics. 2006 Apr;32(4):229-34. (PMID: 16574878); Ann Intern Med. 2002 Sep 17;137(6):511-20. (PMID: 12230353); J Natl Cancer Inst. 2009 Dec 2;101(23):1624-32. (PMID: 19920223); JAMA. 2023 Apr 25;329(16):1404-1406. (PMID: 36995689); Gastroenterology. 2004 Jun;126(7):1700-10. (PMID: 15188165); BMJ. 2001 Jul 7;323(7303):42-6. (PMID: 11440947); Ann Oncol. 2017 Jun 01;28(6):1183-1190. (PMID: 28184420); BMJ Open. 2022 Jun 30;12(6):e062721. (PMID: 35772819); J Clin Epidemiol. 2022 Mar;143:186-196. (PMID: 34742788); Trials. 2021 Nov 8;22(1):783. (PMID: 34749783); Trials. 2011 Sep 09;12:202. (PMID: 21906277); Trials. 2024 Jan 25;25(1):85. (PMID: 38273393); Ann Intern Med. 2011 Jan 18;154(2):113-7. (PMID: 21242367); J Clin Epidemiol. 2022 Nov;151:185-188. (PMID: 36150546); BMJ. 2016 Oct 24;355:i5239. (PMID: 27777223); PLoS One. 2007 Mar 21;2(3):e308. (PMID: 17375194); Cochrane Database Syst Rev. 2011 Apr 13;(4):MR000012. (PMID: 21491415); BMJ Open. 2024 Jan 10;14(1):e074258. (PMID: 38199628); Ann Intern Med. 2012 Sep 18;157(6):429-38. (PMID: 22945832); Control Clin Trials. 2003 Oct;24(5):560-9. (PMID: 14500053); Trials. 2023 Oct 5;24(1):643. (PMID: 37798801); BMJ. 2015 May 27;350:h2445. (PMID: 26016488); N Engl J Med. 2005 May 26;352(21):2202-10. (PMID: 15917385); Can J Cardiol. 2021 Sep;37(9):1322-1331. (PMID: 33276049); Trials. 2022 Sep 27;23(1):812. (PMID: 36167573); J Biopharm Stat. 1999 May;9(2):241-51. (PMID: 10379691); J Clin Epidemiol. 2017 Sep;89:199-208. (PMID: 28535887); Int J Epidemiol. 2017 Apr 1;46(2):746-755. (PMID: 28025257); Int J Epidemiol. 2014 Aug;43(4):1272-83. (PMID: 24881045); J Clin Epidemiol. 2023 Feb;154:42-55. (PMID: 36375641); BMJ. 2013 Mar 21;346:f1135. (PMID: 23518273); Lancet. 2014 Jan 18;383(9913):257-66. (PMID: 24411650); BMJ. 2017 Aug 2;358:j3453. (PMID: 28768629); Stat Med. 2017 Dec 10;36(28):4441-4445. (PMID: 28664566); JAMA. 2007 Mar 21;297(11):1233-40. (PMID: 17374817); BMJ. 2012 Jan 03;344:d8013. (PMID: 22214892); JAMA. 1995 Feb 1;273(5):408-12. (PMID: 7823387); Res Integr Peer Rev. 2024 May 31;9(1):6. (PMID: 38816752); Clin Trials. 2019 Feb;16(1):63-70. (PMID: 30445833); Spine J. 2007 Sep-Oct;7(5):541-6. (PMID: 17448732); Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033. (PMID: 28207928); BMJ. 2014 Mar 07;348:g1687. (PMID: 24609605); J Clin Epidemiol. 2003 Aug;56(8):717-20. (PMID: 12954462); Med Care. 2022 Jan 1;60(1):95-103. (PMID: 34812790); Trials. 2022 Jul 27;23(1):601. (PMID: 35897110); Ann Intern Med. 2010 Sep 21;153(6):400-6. (PMID: 20855804); Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:63-69. (PMID: 33171419); Pilot Feasibility Stud. 2023 May 8;9(1):77. (PMID: 37158925); BMJ. 2007 Jun 9;334(7605):1177-8. (PMID: 17548363); Cochrane Database Syst Rev. 2014 May 09;(5):CD003717. (PMID: 24809816); BMJ. 2024 Jul 9;386:e078525. (PMID: 38981624); AIDS. 2005 Nov 4;19(16):1885-96. (PMID: 16227797); PLoS One. 2010 Oct 08;5(10):e13302. (PMID: 20949049); J Clin Epidemiol. 2015 May;68(5):510-7. (PMID: 25450451); BMC Med Res Methodol. 2013 Jul 16;13:92. (PMID: 23855337); Lancet. 2002 Feb 16;359(9306):614-8. (PMID: 11867132); J Clin Epidemiol. 2016 Jan;69:235-44. (PMID: 26344809); Trials. 2008 Jul 25;9:46. (PMID: 18657271); BMC Med Res Methodol. 2008 Apr 08;8:16. (PMID: 18397525); BMJ. 2010 Mar 23;340:c869. (PMID: 20332511); BMJ. 2012 Jan 03;344:d8141. (PMID: 22214759); JAMA. 2023 Dec 5;330(21):2106-2114. (PMID: 38051324); Ann Intern Med. 2002 Feb 5;136(3):254-9. (PMID: 11827510); J Clin Epidemiol. 1999 Jan;52(1):19-26. (PMID: 9973070); J Clin Epidemiol. 2020 Aug;124:69-74. (PMID: 32360508); J Psychiatr Res. 1999 Mar-Apr;33(2):81-5. (PMID: 10221739); BMJ Open. 2015 Dec 30;5(12):e008431. (PMID: 26719310); BMJ. 2024 Mar 5;384:q324. (PMID: 38443070); Contemp Clin Trials Commun. 2020 Oct 01;20:100658. (PMID: 33083629); BMJ. 2022 Aug 23;378:e070146. (PMID: 35998928); Biom J. 2009 Apr;51(2):348-57. (PMID: 19358221); BMJ. 2008 Dec 04;337:a2299. (PMID: 19056791); Trials. 2016 Dec 16;18(1):34. (PMID: 28114958); J Chronic Dis. 1967 Aug;20(8):637-48. (PMID: 4860352); Trials. 2019 Feb 14;20(1):118. (PMID: 30760329); BMC Med Ethics. 2019 Mar 28;20(1):21. (PMID: 30922290); BMJ. 2009 May 12;338:b1732. (PMID: 19435763); JAMA. 2017 Nov 7;318(17):1709-1711. (PMID: 28892118); BMJ Open. 2019 Feb 24;9(2):e024906. (PMID: 30804032); Trials. 2024 Jan 25;25(1):86. (PMID: 38273319); Drug Saf. 2005;28(10):851-70. (PMID: 16180936); PLoS Med. 2010 Nov 09;7(11):e1000368. (PMID: 21085696); N Engl J Med. 2023 Feb 23;388(8):719-732. (PMID: 36795891); Lancet. 2010 Jul 3;376(9734):20-1. (PMID: 20609983); BMJ Open. 2022 Mar 25;12(3):e057019. (PMID: 35338065); PLoS One. 2014 Jul 28;9(7):e102670. (PMID: 25068257); Clin Trials. 2023 Apr;20(2):121-132. (PMID: 36629015); BMC Med Res Methodol. 2024 Jan 11;24(1):9. (PMID: 38212714); Fed Regist. 2016 Sep 21;81(183):64981-5157. (PMID: 27658315); EClinicalMedicine. 2023 Oct 17;65:102283. (PMID: 37877001); Trials. 2022 Aug 19;23(1):685. (PMID: 35986349); Osteoarthritis Cartilage. 2024 Jan;32(1):8-17. (PMID: 37714259); Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000021. (PMID: 17443636); BMJ. 2005 May 7;330(7499):1049. (PMID: 15817527); BMJ. 2009 Jun 29;338:b2393. (PMID: 19564179); Clin Trials. 2004 Feb;1(1):80-90. (PMID: 16281464); Trials. 2019 Nov 27;20(1):648. (PMID: 31775859); Trials. 2023 May 30;24(1):365. (PMID: 37254217); Fam Pract. 2003 Feb;20(1):83-92. (PMID: 12509377); JAMA. 2013 Nov 27;310(20):2191-4. (PMID: 24141714); PLoS One. 2014 Oct 15;9(10):e110229. (PMID: 25333349); BMJ. 2012 Sep 04;345:e5661. (PMID: 22951546); Cancer. 2008 Jan 15;112(2):228-42. (PMID: 18008363); JAMA. 2022 Dec 20;328(23):2345-2356. (PMID: 36512367); PLoS Med. 2010 Feb 16;7(2):e1000217. (PMID: 20169112); Clin Trials. 2006;3(6):530-7. (PMID: 17170037); Res Synth Methods. 2023 Mar;14(2):144-155. (PMID: 36357935); Am J Public Health. 2008 Aug;98(8):1418-24. (PMID: 18556603); J Clin Oncol. 2004 Sep 1;22(17):3485-90. (PMID: 15337796); J Clin Oncol. 2008 Sep 20;26(27):4458-65. (PMID: 18802158); BMJ. 2025 Apr 28;389:e081477. (PMID: 40294953); Diabetes Care. 2006 Aug;29(8):1833-8. (PMID: 16873788); Health Technol Assess. 2007 Nov;11(48):iii, ix-105. (PMID: 17999843); PLoS One. 2013 Jul 05;8(7):e66844. (PMID: 23861749); N Engl J Med. 2018 May 31;378(22):2115-2122. (PMID: 29847757); BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884); N Engl J Med. 2016 Nov 17;375(20):1998-2004. (PMID: 27635471); Contemp Clin Trials. 2010 Sep;31(5):406. (PMID: 20457277); Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003974. (PMID: 20091554); Lancet. 2009 Jul 4;374(9683):86-9. (PMID: 19525005); J Clin Epidemiol. 2019 Apr;108:17-25. (PMID: 30557676); Clin Trials. 2011 Aug;8(4):440-2. (PMID: 21835863); Trials. 2014 Apr 23;15:139. (PMID: 24755011); BMJ Open. 2019 Jul 17;9(7):e028613. (PMID: 31320354); J Epidemiol Community Health. 1997 Aug;51(4):354-8. (PMID: 9328538); Trials. 2024 Mar 25;25(1):214. (PMID: 38528619); BMJ. 2019 Aug 28;366:l4898. (PMID: 31462531); BMJ. 2008 Apr 19;336(7649):876-80. (PMID: 18364360); BMJ Open. 2023 Apr 3;13(4):e069915. (PMID: 37012015); PLoS Med. 2006 Oct;3(10):e425. (PMID: 17076559); JAMA Netw Open. 2023 Mar 1;6(3):e234226. (PMID: 36951867); Ann Intern Med. 2006 Feb 21;144(4):257-61. (PMID: 16490911); Nat Hum Behav. 2017 Jan 10;1:0021. (PMID: 33954258); Res Involv Engagem. 2022 Jun 7;8(1):25. (PMID: 35672808); Lancet. 2011 Dec 10;378(9808):1995-1996. (PMID: 22153200); BMJ. 2018 Nov 5;363:k3750. (PMID: 30560792); Palliat Med. 2022 Jan;36(1):59-70. (PMID: 35034529); Br J Psychiatry. 2000 Mar;176:249-52. (PMID: 10755072); PLoS Med. 2022 Apr 27;19(4):e1003980. (PMID: 35476675); Trials. 2023 Jan 18;24(1):38. (PMID: 36653812); BMJ. 2011 Jan 12;342:d80. (PMID: 21228020); J Clin Epidemiol. 2022 Apr;144:185-192. (PMID: 34954021); Nat Med. 2022 Sep;28(9):1740-1743. (PMID: 36109642); BMJ. 2022 Feb 7;376:e068177. (PMID: 35131744); J Clin Epidemiol. 2012 Jun;65(6):602-9. (PMID: 22424985); Trials. 2018 Feb 17;19(1):116. (PMID: 29454390); BMJ Open. 2020 Nov 11;10(11):e036366. (PMID: 33177129); BMJ. 2011 Feb 07;342:d40. (PMID: 21300711); JAMA Netw Open. 2022 Jun 1;5(6):e2215209. (PMID: 35653153); BMJ. 2012 Feb 27;344:e1119. (PMID: 22371859); Int J Epidemiol. 2005 Feb;34(1):79-87. (PMID: 15561753); JAMA Intern Med. 2021 Dec 1;181(12):1612-1620. (PMID: 34617959); Surgery. 2006 Apr;139(4):469-83. (PMID: 16627056); J Clin Epidemiol. 2014 Oct;67(10):1059-69. (PMID: 24973822); JAMA. 2012 Dec 26;308(24):2594-604. (PMID: 23268518); BMJ. 2016 Feb 17;352:i637. (PMID: 26888209); JAMA. 2001 Nov 21;286(19):2398-400. (PMID: 11712925); Trials. 2013 Mar 27;14:86. (PMID: 23537389); J Clin Epidemiol. 2000 Oct;53(10):973-9. (PMID: 11027928); J Clin Epidemiol. 2017 Jul;87:35-46. (PMID: 28342907); JAMA. 2015 Apr 28;313(16):1657-65. (PMID: 25919529); J Clin Epidemiol. 2022 Dec;152:248-256. (PMID: 36273772); Trials. 2011 Jan 17;12:14. (PMID: 21235821); J Clin Epidemiol. 2016 Jan;69:152-60. (PMID: 26361993); JAMA. 1999 Nov 10;282(18):1752-9. (PMID: 10568648); Health Technol Assess. 2012 Sep;16(35):1-82. (PMID: 22989478); Eur J Clin Invest. 2019 Aug;49(8):e13145. (PMID: 31135965); BMJ Open. 2021 Aug 18;11(8):e049228. (PMID: 34408052); Trials. 2015 Jan 15;16:12. (PMID: 25928502); BMC Med Res Methodol. 2014 Jan 24;14:11. (PMID: 24456267); Ther Innov Regul Sci. 2023 May;57(3):426-435. (PMID: 36496452); J Clin Transl Sci. 2023 May 15;7(1):e124. (PMID: 37313374); BMC Med Ethics. 2020 Feb 3;21(1):12. (PMID: 32013947); PLoS Med. 2009 Sep;6(9):e1000111. (PMID: 19787044); PLoS Med. 2013 Dec;10(12):e1001566; discussion e1001566. (PMID: 24311990); Arch Orthop Trauma Surg. 2002 Mar;122(2):96-8. (PMID: 11880910); BMJ. 1996 Sep 7;313(7057):570-1. (PMID: 8806240); Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957); Nat Rev Drug Discov. 2017 Jun;16(6):381-382. (PMID: 28529317); Sci Data. 2023 Aug 8;10(1):529. (PMID: 37553403); Eur J Cancer. 2018 Sep;101:244-250. (PMID: 30096705); BMJ. 2012 Jan 03;344:d7202. (PMID: 22214754); BMJ. 1998 Aug 8;317(7155):362-3. (PMID: 9694748); PLoS Med. 2008 Nov 25;5(11):e217; discussion e217. (PMID: 19067477); Obes Rev. 2009 May;10(3):333-41. (PMID: 19389060); Cochrane Database Syst Rev. 2011 Jan 19;(1):MR000031. (PMID: 21249714); Trials. 2022 Sep 14;23(1):775. (PMID: 36104719); Trials. 2022 Aug 17;23(1):674. (PMID: 35978391); BMJ Open. 2023 Oct 4;13(10):e076264. (PMID: 37793922); JAMA Netw Open. 2023 Dec 1;6(12):e2346121. (PMID: 38051535); Trials. 2024 Mar 22;25(1):212. (PMID: 38520030); Health Technol Assess. 1999;3(20):1-143. (PMID: 10683591); BMC Med. 2008 Oct 10;6:28. (PMID: 18847478); Clin Trials. 2018 Oct;15(5):509-521. (PMID: 30070143); J Clin Epidemiol. 2008 Aug;61(8):813-8. (PMID: 18359608); N Engl J Med. 2023 Feb 9;388(6):518-528. (PMID: 36780676); J Clin Epidemiol. 2018 Dec;104:95-102. (PMID: 30196127); J Health Serv Res Policy. 2012 Jan;17(1):1-2. (PMID: 22294719); Trials. 2024 Mar 12;25(1):181. (PMID: 38475894); BMC Med Inform Decis Mak. 2021 Jan 28;21(1):30. (PMID: 33509169); Trials. 2020 Jul 31;21(1):692. (PMID: 32736578); Rheumatology (Oxford). 2008 Jul;47(7):1054-7. (PMID: 18495823); BMJ Open. 2022 Oct 10;12(10):e067117. (PMID: 36216432); Pharm Stat. 2006 Jan-Mar;5(1):7-18. (PMID: 17080924); J Clin Epidemiol. 2023 Oct;162:90-97. (PMID: 37634703); PLoS Med. 2007 Jan;4(1):e19. (PMID: 17227134); J Clin Epidemiol. 2017 Jan;81:42-50. (PMID: 27555081); Trials. 2012 Aug 23;13:145. (PMID: 22917111); BMC Public Health. 2022 Sep 23;22(1):1805. (PMID: 36138375); Clin Trials. 2020 Feb;17(1):99-105. (PMID: 31450958); Trials. 2018 Jul 5;19(1):357. (PMID: 29976227); BMJ. 2019 Oct 9;367:l5342. (PMID: 31597627); BMJ. 2025 Apr 14;389:e081123. (PMID: 40228833); CMAJ. 2018 Jul 30;190(30):E908-E911. (PMID: 30061325); J Clin Epidemiol. 2020 Sep;125:1-8. (PMID: 32416336); Trials. 2022 Aug 4;23(1):634. (PMID: 35927740); Trials. 2009 Jul 02;10:46. (PMID: 19573242); Trials. 2024 Feb 28;25(1):152. (PMID: 38419068); Arch Intern Med. 2010 Nov 22;170(21):1934-9. (PMID: 21098355); Br J Clin Pharmacol. 2017 Sep;83(9):1880-1895. (PMID: 28276585); BMJ. 2005 Jan 8;330(7482):88. (PMID: 15637373); JAMA. 2002 Jun 5;287(21):2825-8. (PMID: 12038924); Clin Trials. 2006;3(4):360-5. (PMID: 17060210); BMJ Med. 2024 Jan 12;3(1):e000738. (PMID: 38274035); PLoS One. 2023 Mar 21;18(3):e0273755. (PMID: 36943835); BMJ. 2010 Mar 30;340:c117. (PMID: 20354011); BMJ. 2023 Apr 24;381:e073725. (PMID: 37094878); Health Technol Assess. 2005 Mar;9(7):1-238, iii-iv. (PMID: 15763038); Lancet. 2004 Dec 4-10;364(9450):2021-9. (PMID: 15582059); Lancet. 2006 May 20;367(9523):1631-3. (PMID: 16714166); Trials. 2023 Aug 7;24(1):498. (PMID: 37550698); BMJ. 2013 Jul 12;347:f4313. (PMID: 23851720); JRSM Open. 2023 Jun 7;14(6):20542704231166621. (PMID: 37325779); Trials. 2024 Feb 28;25(1):151. (PMID: 38419075); Trials. 2022 Sep 20;23(1):789. (PMID: 36127727); Cochrane Database Syst Rev. 2018 Feb 22;2:MR000013. (PMID: 29468635); Lancet. 2002 Feb 9;359(9305):515-9. (PMID: 11853818); Trials. 2022 Apr 18;23(1):328. (PMID: 35436970); Ann Epidemiol. 2006 Jan;16(1):41-8. (PMID: 16275011); Trials. 2022 Apr 5;23(1):260. (PMID: 35382858); Syst Rev. 2023 Oct 13;12(1):196. (PMID: 37833767); BMJ. 2020 Sep 9;370:m3210. (PMID: 32907797); Acta Anaesthesiol Scand. 2021 Jul;65(6):834-845. (PMID: 33583034); BMJ. 2019 Jul 31;366:l4378. (PMID: 31366597); BMJ Med. 2022 Oct 3;1(1):e000309. (PMID: 36936583); BMJ Open. 2021 Apr 13;11(4):e046851. (PMID: 33849856); JAMA. 2004 May 26;291(20):2457-65. (PMID: 15161896); JAMA. 2017 Dec 19;318(23):2337-2343. (PMID: 29260229); Trials. 2016 Mar 01;17(1):115. (PMID: 26931619); BMC Med Ethics. 2021 Aug 28;22(1):115. (PMID: 34454496); JAMA Intern Med. 2017 Apr 1;177(4):554-560. (PMID: 28192563); BMC Med Res Methodol. 2014 Nov 19;14:118. (PMID: 25407057); BMJ. 2023 Oct 20;383:e076386. (PMID: 37863491); Am J Epidemiol. 2018 May 1;187(5):1113-1122. (PMID: 29126260); Int Urogynecol J. 2020 May;31(5):1033-1040. (PMID: 31875256); JAMA. 2001 Apr 18;285(15):2000-3. (PMID: 11308438); Pilot Feasibility Stud. 2021 Feb 3;7(1):40. (PMID: 33536076); PLoS One. 2011;6(9):e25348. (PMID: 21966505); Clin Trials. 2017 Aug;14(4):342-348. (PMID: 28503947); JAMA. 2006 Apr 12;295(14):1645-6. (PMID: 16609085); Hastings Cent Rep. 2004 Jan-Feb;34(1):25-33. (PMID: 15098404); PLoS Med. 2007 Feb;4(2):e61. (PMID: 17311468); Trials. 2015 Dec 30;16:597. (PMID: 26715378); Trials. 2023 Jun 30;24(1):436. (PMID: 37391773); Int J Epidemiol. 2010 Feb;39(1):94-6. (PMID: 19776246); Clin Pharmacol Ther. 2011 Nov;90(5):732-6. (PMID: 21993424); Trials. 2023 Apr 11;24(1):267. (PMID: 37041631); JAMA. 2006 Mar 8;295(10):1152-60. (PMID: 16522836); BMJ. 2012 May 18;344:e2809. (PMID: 22611167); BMJ Open. 2020 Dec 29;10(12):e041849. (PMID: 33376175); JAMA. 2021 Aug 10;326(6):490-498. (PMID: 34269813); Eval Health Prof. 2002 Mar;25(1):38-64. (PMID: 11868444); J Natl Cancer Inst. 2008 Apr 2;100(7):483-91. (PMID: 18364501); BMJ Open. 2020 Sep 21;10(9):e036899. (PMID: 32958486); JAMA Netw Open. 2024 Apr 1;7(4):e246228. (PMID: 38607626); BMJ Open. 2021 Jun 30;11(6):e045105. (PMID: 34193486); Health Technol Assess. 2015 Feb;19(11):1-138. (PMID: 25671821); J Clin Epidemiol. 1999 Dec;52(12):1143-56. (PMID: 10580777); J R Soc Med. 2023 Oct;116(10):343-350. (PMID: 37961883); Patient Educ Couns. 2008 Dec;73(3):497-503. (PMID: 18701235); J Clin Oncol. 2018 Feb 20;36(6):617-623. (PMID: 29236570); Trials. 2019 Feb 14;20(1):124. (PMID: 30760328); JAMA. 2004 Sep 15;292(11):1363-4. (PMID: 15355936); Trials. 2021 Oct 29;22(1):752. (PMID: 34715906); J Psychosom Res. 2020 Aug;135:110132. (PMID: 32521358); JAMA. 2003 Jul 23;290(4):516-23. (PMID: 12876095); JAMA Netw Open. 2021 Oct 1;4(10):e2131503. (PMID: 34705015); JAMA. 2019 Apr 23;321(16):1610-1620. (PMID: 31012939); PLoS One. 2023 Aug 31;18(8):e0290725. (PMID: 37651373); Eye (Lond). 2022 Nov;36(11):2073-2074. (PMID: 35585134); JAMA. 2021 Jul 20;326(3):230-239. (PMID: 34283183); BMJ. 2017 Jan 17;356:i6770. (PMID: 28096109); BMJ. 2015 May 08;350:h2147. (PMID: 25956159); BMJ Open. 2022 May 24;12(5):e053417. (PMID: 35613804); PLoS One. 2020 Apr 22;15(4):e0230416. (PMID: 32320428); Clin Trials. 2024 Apr;21(2):152-161. (PMID: 37877375); Trials. 2024 Feb 14;25(1):120. (PMID: 38355627); Lancet. 2010 Apr 3;375(9721):1144-6. (PMID: 20338625); Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193. (PMID: 20181324) |
| Entry Date(s): | Date Created: 20250428 Latest Revision: 20250911 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC12128891 |
| DOI: | 10.1136/bmj-2024-081660 |
| PMID: | 40294956 |
| Database: | MEDLINE |
Journal Article; Comment