Interpreting Patient-Reported Outcome Measures in Orthopaedic Surgery: A Systematic Review.
Journal
The Journal of bone and joint surgery. American volume
ISSN: 1535-1386
Titre abrégé: J Bone Joint Surg Am
Pays: United States
ID NLM: 0014030
Informations de publication
Date de publication:
20 Jan 2021
20 Jan 2021
Historique:
pubmed:
18
9
2020
medline:
11
5
2021
entrez:
17
9
2020
Statut:
ppublish
Résumé
The Consolidated Standards of Reporting Trials (CONSORT) Statement recommends that studies report results beyond p values and include treatment effect(s) and measures of precision (e.g., confidence intervals [CIs]) to facilitate the interpretation of results. The objective of this systematic review was to assess the reporting and interpretation of patient-reported outcome measure (PROM) results in clinical studies from high-impact orthopaedic journals, to determine the proportion of studies that (1) only reported a p value; (2) reported a treatment effect, CI, or minimal clinically important difference (MCID); and (3) offered an interpretation of the results beyond interpreting a p value. We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 intervention groups using PROMs. A total of 228 studies were analyzed, including 126 randomized controlled trials, 35 prospective cohort studies, 61 retrospective cohort studies, 1 mixed cohort study, and 5 case-control studies. Seventy-six percent of studies (174) reported p values exclusively to express and interpret between-group differences, and only 22.4% (51) reported a treatment effect (mean difference, mean change, or odds ratio) with 95% CI. Of the 54 studies reporting a treatment effect, 31 interpreted the results using an important threshold (MCID, margin, or Cohen d), but only 3 interpreted the CIs. We found an absolute improvement of 35.5% (95% CI, 20.8% to 48.4%) in the reporting of the MCID between 2017 and 2019. The majority of interventional studies reporting PROMs do not report CIs around between-group differences in outcome and do not define a clinically meaningful difference. A p value cannot effectively communicate the readiness for implementation in a clinical setting and may be misleading. Thus, reporting requirements should be expanded to require authors to define and provide a rationale for between-group clinically important difference thresholds, and study findings should be communicated by comparing CIs with these thresholds.
Sections du résumé
BACKGROUND
BACKGROUND
The Consolidated Standards of Reporting Trials (CONSORT) Statement recommends that studies report results beyond p values and include treatment effect(s) and measures of precision (e.g., confidence intervals [CIs]) to facilitate the interpretation of results. The objective of this systematic review was to assess the reporting and interpretation of patient-reported outcome measure (PROM) results in clinical studies from high-impact orthopaedic journals, to determine the proportion of studies that (1) only reported a p value; (2) reported a treatment effect, CI, or minimal clinically important difference (MCID); and (3) offered an interpretation of the results beyond interpreting a p value.
METHODS
METHODS
We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 intervention groups using PROMs.
RESULTS
RESULTS
A total of 228 studies were analyzed, including 126 randomized controlled trials, 35 prospective cohort studies, 61 retrospective cohort studies, 1 mixed cohort study, and 5 case-control studies. Seventy-six percent of studies (174) reported p values exclusively to express and interpret between-group differences, and only 22.4% (51) reported a treatment effect (mean difference, mean change, or odds ratio) with 95% CI. Of the 54 studies reporting a treatment effect, 31 interpreted the results using an important threshold (MCID, margin, or Cohen d), but only 3 interpreted the CIs. We found an absolute improvement of 35.5% (95% CI, 20.8% to 48.4%) in the reporting of the MCID between 2017 and 2019.
CONCLUSIONS
CONCLUSIONS
The majority of interventional studies reporting PROMs do not report CIs around between-group differences in outcome and do not define a clinically meaningful difference. A p value cannot effectively communicate the readiness for implementation in a clinical setting and may be misleading. Thus, reporting requirements should be expanded to require authors to define and provide a rationale for between-group clinically important difference thresholds, and study findings should be communicated by comparing CIs with these thresholds.
Identifiants
pubmed: 32941309
pii: 00004623-202101200-00012
doi: 10.2106/JBJS.20.00474
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
185-190Informations de copyright
Copyright © 2020 by The Journal of Bone and Joint Surgery, Incorporated.
Déclaration de conflit d'intérêts
Disclosure: The authors indicated that no external funding was received for any aspect of this work. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work (http://links.lww.com/JBJS/G116).
Références
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):834-40. Epub 2010 Mar 25.
Nagendran M, Harding D, Teo W, Camm C, Maruthappu M, McCulloch P, Hopewell S. Poor adherence of randomised trials in surgery to CONSORT guidelines for non-pharmacological treatments (NPT): a cross-sectional study. BMJ Open. 2013 Dec 18;3(12):e003898.
Gardner MJ, Altman DG. Confidence intervals rather than p values: estimation rather than hypothesis testing. Br Med J (Clin Res Ed). 1986 Mar 15;292(6522):746-50.
Harris JD, Brand JC, Cote MP, Faucett SC, Dhawan A. Research pearls: the significance of statistics and perils of pooling. Part 1: clinical versus statistical significance. Arthroscopy. 2017 Jun;33(6):1102-12. Epub 2017 Apr 25.
Sullivan GM, Feinn R. Using effect size-or why the p value is not enough. J Grad Med Educ. 2012 Sep;4(3):279-82.
Guyatt G, Jaeschke R, Heddle N, Cook D, Shannon H, Walter S. Basic statistics for clinicians: 2. Interpreting study results: confidence intervals. CMAJ. 1995 Jan 15;152(2):169-73.
Kamper SJ. Confidence intervals: linking evidence to practice. J Orthop Sports Phys Ther. 2019 Oct;49(10):763-4.
Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15.
Wang B, Wang H, Tu XM, Feng C. Comparisons of superiority, non-inferiority, and equivalence trials. Shanghai Arch Psychiatry. 2017 Dec 25;29(6):385-8.
Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures-a randomized, controlled, clinical trial. J Orthop Trauma. 2009 Feb;23(2):106-12.
Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration; 2011. Accessed 2018 Oct 30. www.handbook.cochrane.org
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8(5):336-41. Epub 2010 Feb 18.
Clarivate Analytics. InCites Journal Citation Reports. 2017. Accessed 2018 Oct 12. https://jcr.clarivate.com/JCRJournalHomeAction.action
McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb). 2012;22(3):276-82.
Page P. Beyond statistical significance: clinical interpretation of rehabilitation research literature. Int J Sports Phys Ther. 2014 Oct;9(5):726-36.
Wasserstein RL, Schirm AL, Lazar NA. Moving to a world beyond “p < 0.05.” Am Stat. 2019;73(sup1):1-19.
Thiese MS, Ronna B, Ott U. P value interpretations and considerations. J Thorac Dis. 2016 Sep;8(9):E928-31.
Goodman S. A dirty dozen: twelve p-value misconceptions. Semin Hematol. 2008 Jul;45(3):135-40.
Nahm FS. What the p values really tell us. Korean J Pain. 2017 Oct;30(4):241-2. Epub 2017 Sep 29.
Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995 Aug 19;311(7003):485.
Abdullah L, Davis DE, Fabricant PD, Baldwin K, Namdari S. Is there truly “no significant difference”? Underpowered randomized controlled trials in the orthopaedic literature. J Bone Joint Surg Am. 2015 Dec 16;97(24):2068-73.
Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature. 2019 Mar;567(7748):305-7.
Bhandari M, Montori VM, Schemitsch EH. The undue influence of significant p-values on the perceived importance of study results. Acta Orthop. 2005 Jun;76(3):291-5.
Wasserstein RL, Lazar NA. The ASA statement on p-values: context, process, and purpose. Am Stat. 2016;70(2):129-33.
Gagnier JJ, Morgenstern H. Misconceptions, misuses, and misinterpretations of p values and significance testing. J Bone Joint Surg Am. 2017 Sep 20;99(18):1598-603.
Vavken P, Heinrich KM, Koppelhuber C, Rois S, Dorotka R. The use of confidence intervals in reporting orthopaedic research findings. Clin Orthop Relat Res. 2009 Dec;467(12):3334-9. Epub 2009 Mar 31.
Karadaghy OA, Hong H, Scott-Wittenborn N, Sinha P, Suko J, Tait S, Wamkpah NS, Kallogjeri D, Piccirillo JF. Reporting of effect size and confidence intervals in JAMA Otolaryngology-Head & Neck Surgery. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1075-80.
Finch S, Cumming G. Putting research in context: understanding confidence intervals from one or more studies. J Pediatr Psychol. 2009 Oct;34(9):903-16. Epub 2008 Dec 18.
Copay AG, Chung AS, Eyberg B, Olmscheid N, Chutkan N, Spangehl MJ. Minimum clinically important difference: current trends in the orthopaedic literature, part I: upper extremity: a systematic review. JBJS Rev. 2018 Sep;6(9):e1.
Copay AG, Eyberg B, Chung AS, Zurcher KS, Chutkan N, Spangehl MJ. Minimum clinically important difference: current trends in the orthopaedic literature, part II: lower extremity: a systematic review. JBJS Rev. 2018 Sep;6(9):e2.
Kamper SJ. Interpreting outcomes 1-change and difference: linking evidence to practice. J Orthop Sports Phys Ther. 2019 May;49(5):357-8.
Musahl V, Karlsson J, Hirschmann MT, Ayeni OR, Marx RG, Koh JL, Nakamura N, editors. Basic methods handbook for clinical orthopaedic research. A practical guide and case based research approach. Springer; 2019.
Goldsmith CH, Boers M, Bombardier C, Tugwell P; OMERACT Committee. Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. J Rheumatol. 1993 Mar;20(3):561-5.
Warby SA, Ford JJ, Hahne AJ, Watson L, Balster S, Lenssen R, Pizzari T. Comparison of 2 exercise rehabilitation programs for multidirectional instability of the glenohumeral joint: a randomized controlled trial. Am J Sports Med. 2018 Jan;46(1):87-97. Epub 2017 Oct 19.
Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Effectiveness of radial extracorporeal shock wave therapy (rESWT) when combined with supervised exercises in patients with subacromial shoulder pain: a double-masked, randomized, sham-controlled trial. Am J Sports Med. 2017 Sep;45(11):2547-54. Epub 2017 Jun 6.
Garfield E. The Clarivate Analytics impact factor. Accessed 2020 Jul 28. https://clarivate.com/webofsciencegroup/essays/impact-factor/