Item request has been placed!
×
Item request cannot be made.
×
![loading](/sites/all/modules/hf_eds/images/loading.gif)
Processing Request
Statistical analyses of ordinal outcomes in randomised controlled trials: a scoping review.
Item request has been placed!
×
Item request cannot be made.
×
![loading](/sites/all/modules/hf_eds/images/loading.gif)
Processing Request
- معلومة اضافية
- المصدر:
Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials
- بيانات النشر:
Original Publication: [London] : BioMed Central, 2006-
- الموضوع:
- نبذة مختصرة :
Background: Randomised controlled trials (RCTs) aim to estimate the causal effect of one or more interventions relative to a control. One type of outcome that can be of interest in an RCT is an ordinal outcome, which is useful to answer clinical questions regarding complex and evolving patient states. The target parameter of interest for an ordinal outcome depends on the research question and the assumptions the analyst is willing to make. This review aimed to provide an overview of how ordinal outcomes have been used and analysed in RCTs.
Methods: The review included RCTs with an ordinal primary or secondary outcome published between 2017 and 2022 in four highly ranked medical journals (the British Medical Journal, New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association) identified through PubMed. Details regarding the study setting, design, the target parameter, and statistical methods used to analyse the ordinal outcome were extracted.
Results: The search identified 309 studies, of which 144 were eligible for inclusion. The most used target parameter was an odds ratio, reported in 78 (54%) studies. The ordinal outcome was dichotomised for analysis in 47 ( 33 % ) studies, and the most common statistical model used to analyse the ordinal outcome on the full ordinal scale was the proportional odds model (64 [ 44 % ] studies). Notably, 86 (60%) studies did not explicitly check or describe the robustness of the assumptions for the statistical method(s) used.
Conclusions: The results of this review indicate that in RCTs that use an ordinal outcome, there is variation in the target parameter and the analytical approaches used, with many dichotomising the ordinal outcome. Few studies provided assurance regarding the appropriateness of the assumptions and methods used to analyse the ordinal outcome. More guidance is needed to improve the transparent reporting of the analysis of ordinal outcomes in future trials.
(© 2024. The Author(s).)
- References:
Stroke. 2007 Mar;38(3):1091-6. (PMID: 17272767)
JAMA. 2021 Dec 07;326(21):2161-2171. (PMID: 34874419)
Lancet. 2022 Mar 12;399(10329):1059-1069. (PMID: 35240044)
JAMA. 2018 Jan 9;319(2):130-142. (PMID: 29318278)
N Engl J Med. 2021 Apr 22;384(16):1491-1502. (PMID: 33631065)
JAMA. 2018 Jul 17;320(3):245-254. (PMID: 29959443)
N Engl J Med. 2019 Aug 15;381(7):614-625. (PMID: 31050279)
BMJ. 2022 Feb 21;376:e065846. (PMID: 35190388)
Cad Saude Publica. 2008;24 Suppl 4:s581-91. (PMID: 18797732)
N Engl J Med. 2021 Nov 18;385(21):1951-1960. (PMID: 34407339)
BMJ Open. 2021 Nov 30;11(11):e053684. (PMID: 34848523)
JAMA. 2020 Sep 8;324(10):961-974. (PMID: 32897344)
N Engl J Med. 2020 May 7;382(19):1787-1799. (PMID: 32187464)
Lancet. 2017 Aug 5;390(10094):588-599. (PMID: 28666682)
JAMA. 2020 Sep 15;324(11):1048-1057. (PMID: 32821939)
Lancet. 2020 Mar 14;395(10227):878-887. (PMID: 32087818)
Lancet. 2019 Mar 2;393(10174):877-888. (PMID: 30739745)
N Engl J Med. 2020 Apr 16;382(16):1497-1506. (PMID: 32294346)
N Engl J Med. 2020 Jul 16;383(3):229-239. (PMID: 32668113)
N Engl J Med. 2019 May 9;380(19):1795-1803. (PMID: 31067369)
Lancet. 2019 Aug 3;394(10196):385-395. (PMID: 31227373)
JAMA. 2022 Mar 1;327(9):826-835. (PMID: 35143603)
Neurotherapeutics. 2010 Jan;7(1):127-34. (PMID: 20129504)
Lancet. 2017 Feb 11;389(10069):603-611. (PMID: 28081952)
Br Med J (Clin Res Ed). 1986 Jan 4;292(6512):40-3. (PMID: 3080061)
N Engl J Med. 2018 Feb 22;378(8):708-718. (PMID: 29364767)
N Engl J Med. 2021 Jul 22;385(4):309-319. (PMID: 34289275)
Lancet. 2021 Sep 18;398(10305):1065-1073. (PMID: 34469763)
N Engl J Med. 2022 Feb 24;386(8):724-734. (PMID: 35196426)
JAMA. 2021 Nov 02;326(17):1690-1702. (PMID: 34606578)
Stat Med. 2018 Sep 10;37(20):2923-2937. (PMID: 29774591)
JAMA. 2018 Jul 24;320(4):368-378. (PMID: 30043066)
N Engl J Med. 2021 Aug 26;385(9):790-802. (PMID: 34351721)
BMJ. 2017 Apr 7;357:j1341. (PMID: 28389435)
JAMA. 2018 Aug 28;320(8):779-791. (PMID: 30167701)
BMJ. 2018 May 2;361:k1662. (PMID: 29720374)
JAMA. 2020 Dec 1;324(21):2165-2176. (PMID: 33165621)
JAMA. 2021 Jan 19;325(3):234-243. (PMID: 33464335)
Soc Sci Res. 2012 Jan;41(1):182-98. (PMID: 23017706)
N Engl J Med. 2019 Jun 27;380(26):2506-2517. (PMID: 31112380)
N Engl J Med. 2020 Dec 31;383(27):2616-2627. (PMID: 33326713)
JAMA. 2018 Mar 6;319(9):872-882. (PMID: 29509867)
N Engl J Med. 2018 Jun 21;378(25):2376-2385. (PMID: 29924955)
Lancet. 2019 Oct 19;394(10207):1425-1436. (PMID: 31522846)
N Engl J Med. 2022 Jul 14;387(2):148-159. (PMID: 35830641)
JAMA. 2022 May 10;327(18):1795-1805. (PMID: 35510389)
Lancet. 2018 Sep 22;392(10152):1058-1070. (PMID: 30177236)
JAMA. 2022 May 17;327(19):1899-1909. (PMID: 35506515)
N Engl J Med. 2021 Mar 25;384(12):1101-1112. (PMID: 33761207)
N Engl J Med. 2020 May 21;382(21):1981-1993. (PMID: 32374959)
N Engl J Med. 2018 Aug 16;379(7):611-622. (PMID: 29766770)
JAMA. 2017 Apr 11;317(14):1422-1432. (PMID: 28322416)
Lancet. 2020 May 16;395(10236):1569-1578. (PMID: 32423584)
J Clin Epidemiol. 2009 Apr;62(4):387-92. (PMID: 19010643)
N Engl J Med. 2020 Jul 16;383(3):207-217. (PMID: 32668111)
Am J Epidemiol. 1989 Jan;129(1):191-204. (PMID: 2910061)
JAMA. 2021 May 25;325(20):2056-2066. (PMID: 34032829)
N Engl J Med. 2018 Apr 26;378(17):1573-1582. (PMID: 29694815)
JAMA. 2020 Oct 6;324(13):1307-1316. (PMID: 32876695)
N Engl J Med. 2020 Jul 9;383(2):141-150. (PMID: 32640132)
N Engl J Med. 2020 Dec 24;383(26):2501-2513. (PMID: 33369354)
Stat Med. 2008 Aug 15;27(18):3598-611. (PMID: 18338319)
N Engl J Med. 2019 Dec 12;381(24):2327-2337. (PMID: 31577396)
Lancet. 2019 Jan 19;393(10168):265-274. (PMID: 30528472)
N Engl J Med. 2020 Nov 5;383(19):1827-1837. (PMID: 32459919)
N Engl J Med. 2021 May 20;384(20):1910-1920. (PMID: 34010530)
JAMA. 2017 Sep 19;318(11):1047-1056. (PMID: 28975307)
JAMA. 2020 Apr 7;323(13):1257-1265. (PMID: 32078683)
N Engl J Med. 2017 Apr 6;376(14):1341-1349. (PMID: 28379802)
N Engl J Med. 2022 Apr 7;386(14):1303-1313. (PMID: 35138767)
N Engl J Med. 2018 Aug 23;379(8):711-721. (PMID: 30021076)
JAMA. 2021 Nov 23;326(20):2021-2030. (PMID: 34812863)
Life (Basel). 2020 Dec 15;10(12):. (PMID: 33333777)
BMJ. 2019 Sep 18;366:l5101. (PMID: 31533934)
Lancet. 2021 Jun 5;397(10290):2151-2168. (PMID: 34023008)
Lancet. 2019 Mar 9;393(10175):1009-1020. (PMID: 30738649)
Lancet. 2021 Jan 9;397(10269):112-118. (PMID: 33357465)
J Neurotrauma. 2021 Sep 1;38(17):2435-2446. (PMID: 33740873)
N Engl J Med. 2017 Jun 22;376(25):2437-2447. (PMID: 28636854)
Lancet. 2021 Feb 6;397(10273):475-486. (PMID: 33549192)
N Engl J Med. 2019 Jun 06;380(23):2225-2236. (PMID: 31166681)
N Engl J Med. 2021 Nov 11;385(20):1833-1844. (PMID: 34758251)
N Engl J Med. 2018 Jan 4;378(1):22-34. (PMID: 29262271)
Lancet. 2021 Jun 5;397(10290):2169-2181. (PMID: 34023009)
Lancet. 2017 Mar 18;389(10074):1103-1113. (PMID: 28185672)
N Engl J Med. 2021 Jul 29;385(5):406-415. (PMID: 34133856)
JAMA. 2021 May 11;325(18):1863-1873. (PMID: 33974020)
Stat Med. 2019 Apr 15;38(8):1484-1501. (PMID: 30609115)
JAMA. 2017 Aug 1;318(5):443-452. (PMID: 28763550)
J Clin Epidemiol. 1997 Jan;50(1):45-55. (PMID: 9048689)
JAMA. 2021 Jan 19;325(3):244-253. (PMID: 33464334)
JAMA. 2022 Aug 23;328(8):772-773. (PMID: 35925592)
N Engl J Med. 2021 Jan 7;384(1):31-41. (PMID: 33200890)
Lancet. 2018 Dec 8;392(10163):2452-2464. (PMID: 30473366)
Neurology. 2018 Nov 20;91(21):e1951-e1960. (PMID: 30341155)
BMJ. 2021 Jan 20;372:n84. (PMID: 33472855)
Biometrika. 1967 Jun;54(1):167-79. (PMID: 6049533)
JAMA. 2019 Jul 23;322(4):326-335. (PMID: 31334795)
BMJ. 2018 Jun 13;361:k2241. (PMID: 29899047)
N Engl J Med. 2020 Mar 19;382(12):1103-1111. (PMID: 32068366)
Lancet. 2022 Feb 5;399(10324):530-540. (PMID: 35093205)
N Engl J Med. 2021 Jun 17;384(24):2283-2294. (PMID: 34133859)
Cochrane Database Syst Rev. 2019 Oct 3;10:ED000142. (PMID: 31643080)
Lancet. 2020 Sep 26;396(10255):909-917. (PMID: 32979978)
N Engl J Med. 2021 Aug 26;385(9):777-789. (PMID: 34351722)
N Engl J Med. 2019 Sep 5;381(10):903-911. (PMID: 31483961)
Lancet. 2018 Mar 3;391(10123):850-859. (PMID: 29274727)
N Engl J Med. 2017 May 25;376(21):2011-2020. (PMID: 28538134)
JAMA. 2018 Jul 10;320(2):156-166. (PMID: 29998337)
Lancet. 2019 Oct 12;394(10206):1352-1363. (PMID: 31495497)
Lancet Infect Dis. 2020 Aug;20(8):e192-e197. (PMID: 32539990)
N Engl J Med. 2019 Nov 28;381(22):2114-2124. (PMID: 31774956)
JAMA. 2019 Oct 22;322(16):1561-1569. (PMID: 31638682)
N Engl J Med. 2021 Dec 9;385(24):2219-2229. (PMID: 34879448)
Ann Intern Med. 2018 Oct 2;169(7):467-473. (PMID: 30178033)
Lancet. 2017 Apr 15;389(10078):1528-1538. (PMID: 28256356)
Trials. 2023 Apr 21;24(1):286. (PMID: 37085929)
Crit Care. 2011;15(3):R127. (PMID: 21586148)
JAMA. 2017 Apr 4;317(13):1329-1337. (PMID: 28384828)
N Engl J Med. 2019 Mar 7;380(10):915-923. (PMID: 30855741)
JAMA. 2022 May 10;327(18):1782-1794. (PMID: 35510397)
Lancet Reg Health Am. 2022 Jun;10:100216. (PMID: 35308034)
JAMA. 2017 Feb 14;317(6):596-605. (PMID: 28196254)
N Engl J Med. 2018 Jan 4;378(1):11-21. (PMID: 29129157)
N Engl J Med. 2017 Mar 2;376(9):826-835. (PMID: 28249150)
JAMA. 2021 Oct 26;326(16):1595-1605. (PMID: 34698782)
JAMA. 2021 Sep 14;326(10):926-939. (PMID: 34519802)
Stat Med. 2009 Nov 20;28(26):3189-209. (PMID: 19455540)
N Engl J Med. 2017 May 18;376(20):1921-1932. (PMID: 28514601)
Clin Trials. 2010 Feb;7(1):44-57. (PMID: 20156956)
Stat Med. 2006 Dec 30;25(24):4227-34. (PMID: 16929469)
BMJ. 2022 Apr 6;377:e068446. (PMID: 35387783)
Lancet. 2022 Jul 9;400(10346):104-115. (PMID: 35810756)
JAMA. 2017 Sep 26;318(12):1125-1135. (PMID: 28973619)
N Engl J Med. 2018 Feb 8;378(6):507-517. (PMID: 29414272)
JAMA. 2017 Jul 11;318(2):132-145. (PMID: 28697253)
JAMA. 2022 Feb 22;327(8):727-736. (PMID: 35191924)
Lancet. 2022 Jul 9;400(10346):116-125. (PMID: 35810757)
JAMA. 2019 Dec 3;322(21):2084-2094. (PMID: 31794625)
JAMA. 2017 Jul 04;318(1):68-81. (PMID: 28672319)
Lancet. 2019 Mar 9;393(10175):998-1008. (PMID: 30860055)
Stat Med. 2017 Nov 30;36(27):4316-4335. (PMID: 28872693)
Int J Stroke. 2014 Feb;9(2):226-31. (PMID: 23803174)
Int J Epidemiol. 1997 Dec;26(6):1323-33. (PMID: 9447413)
Lancet. 2020 Oct 3;396(10256):959-967. (PMID: 32896292)
N Engl J Med. 2021 Feb 11;384(6):512-520. (PMID: 33567191)
N Engl J Med. 2021 Feb 25;384(8):717-726. (PMID: 33626254)
N Engl J Med. 2017 Mar 23;376(12):1111-1120. (PMID: 28328324)
Stroke. 2008 Oct;39(10):2817-23. (PMID: 18669897)
N Engl J Med. 2021 Mar 11;384(10):905-914. (PMID: 33356051)
N Engl J Med. 2019 Sep 26;381(13):1215-1226. (PMID: 31553834)
N Engl J Med. 2020 Feb 20;382(8):706-716. (PMID: 32074418)
N Engl J Med. 2017 Oct 26;377(17):1639-1647. (PMID: 29069568)
Lancet. 2020 Jul 25;396(10246):255-266. (PMID: 32711801)
JAMA. 2018 Aug 28;320(8):769-778. (PMID: 30167699)
JAMA. 2018 Dec 11;320(22):2344-2353. (PMID: 30535218)
N Engl J Med. 2020 Nov 5;383(19):1813-1826. (PMID: 32445440)
Lancet. 2022 Jul 16;400(10347):161-169. (PMID: 35779553)
N Engl J Med. 2021 Feb 18;384(7):619-629. (PMID: 33232588)
N Engl J Med. 2020 Apr 9;382(15):1420-1429. (PMID: 32268027)
N Engl J Med. 2020 Nov 19;383(21):2041-2052. (PMID: 32706953)
BMJ. 2020 Sep 9;370:m3027. (PMID: 33315586)
BMC Med Res Methodol. 2014 Nov 19;14:118. (PMID: 25407057)
Lancet. 2021 Feb 6;397(10273):487-498. (PMID: 33549193)
N Engl J Med. 2017 Aug 24;377(8):733-744. (PMID: 28834483)
Lancet. 2022 Jul 2;400(10345):39-47. (PMID: 35780790)
Stroke. 2007 Nov;38(11):3055-62. (PMID: 17916765)
N Engl J Med. 2018 Jan 11;378(2):148-157. (PMID: 29320647)
JAMA. 2018 Dec 4;320(21):2211-2220. (PMID: 30357266)
N Engl J Med. 2021 Apr 22;384(16):1503-1516. (PMID: 33631066)
BMJ. 2019 Nov 6;367:l5896. (PMID: 31694810)
Lancet. 2019 Mar 9;393(10175):1021-1032. (PMID: 30739747)
JAMA. 2019 Jan 15;321(2):165-174. (PMID: 30644983)
JAMA. 2022 Jan 18;327(3):227-236. (PMID: 35040887)
Lancet. 2018 May 26;391(10135):2107-2115. (PMID: 29778325)
Lancet. 2017 Jul 29;390(10093):480-489. (PMID: 28619476)
N Engl J Med. 2020 Jun 11;382(24):2316-2326. (PMID: 32521133)
- Grant Information:
ID 1171422 National Health and Medical Research Council; ID 1035261 National Health and Medical Research Council; ID 1127984 National Health and Medical Research Council; 1159225 National Health and Medical Research Council
- Contributed Indexing:
Keywords: Ordinal outcomes; Proportional odds model; Randomised controlled trials; Scoping review
- الموضوع:
Date Created: 20240406 Date Completed: 20240807 Latest Revision: 20240807
- الموضوع:
20240808
- الرقم المعرف:
PMC10998402
- الرقم المعرف:
10.1186/s13063-024-08072-2
- الرقم المعرف:
38582924
No Comments.