Incomplete reporting of patient-reported outcomes in multiple sclerosis: A meta-epidemiological study of randomized controlled trials.

Humans Multiple Sclerosis / epidemiology Patient Reported Outcome Measures Quality of Life Randomized Controlled Trials as Topic
CONSORT-PRO Completeness of reporting Multiple Sclerosis Patient-reported outcome Quality of life Randomised controlled trials

Journal

Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247

Informations de publication

Date de publication:
Jul 2022
Historique:
received: 08 08 2021
revised: 25 03 2022
accepted: 21 04 2022
pubmed: 30 4 2022
medline: 29 6 2022
entrez: 29 4 2022
Statut: ppublish

Résumé

Multiple Sclerosis significantly affects quality of life, which is often measured by patient-reported outcomes. The incorporation of patient-reported outcomes within clinical trials supplements the efficacy of outcomes in order to provide a patient's perspective for clinicians. Our objective was to evaluate current literature for completeness of reporting of PROs in randomized controlled trials (RCTs) for the management of MS. We used MEDLINE, Embase, and Cochrane Central Register of Controlled Trials to search for RCT publications investigating the management of MS. After duplicate screening via Rayyan, RCTs fitting our inclusion criteria were abstracted employing the Consolidated Standards of Reporting Trials - Patient-Reported Outcome (CONSORT-PRO) adaptation and the Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Mean percent completion of an adaptation of CONSORT-PRO was calculated to address completeness of reporting. In addition, bivariate regression models were used to evaluate relationships between trial characteristics and completeness of reporting. Our search returned 3,966 results and 92 RCTs were included for data abstraction and analysis. We found an overall completion of 48.68% (SD=19.03). Sixty-five (of 92; 70.65%) of the RCTs were evaluated as having 'high' RoB. There were significant associations between completeness of reporting and the following: mention of CONSORT within published RCTs (t=2.55, p=.013), length of PRO follow-up (t=2.9, p=.005; t=2.14, p=.035), and sample size (t=3.12, p=.002). No other significant associations were found. Our study found incomplete adherence to the CONSORT-PRO adaptation among RCTs pertaining to MS. Of the most underreported items, the failure to report a hypothesis and define an approach to missing data threaten the validity of the evidence acquired from RCTs. Furthermore, PROs provide an opportunity to supplement trial outcomes with the patient's perspective. Thus, trialists of future RCTs may improve PRO reporting with increased adherence to the CONSORT-PRO adaptation.

Sections du résumé

BACKGROUND BACKGROUND
Multiple Sclerosis significantly affects quality of life, which is often measured by patient-reported outcomes. The incorporation of patient-reported outcomes within clinical trials supplements the efficacy of outcomes in order to provide a patient's perspective for clinicians. Our objective was to evaluate current literature for completeness of reporting of PROs in randomized controlled trials (RCTs) for the management of MS.
METHODS METHODS
We used MEDLINE, Embase, and Cochrane Central Register of Controlled Trials to search for RCT publications investigating the management of MS. After duplicate screening via Rayyan, RCTs fitting our inclusion criteria were abstracted employing the Consolidated Standards of Reporting Trials - Patient-Reported Outcome (CONSORT-PRO) adaptation and the Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Mean percent completion of an adaptation of CONSORT-PRO was calculated to address completeness of reporting. In addition, bivariate regression models were used to evaluate relationships between trial characteristics and completeness of reporting.
RESULTS RESULTS
Our search returned 3,966 results and 92 RCTs were included for data abstraction and analysis. We found an overall completion of 48.68% (SD=19.03). Sixty-five (of 92; 70.65%) of the RCTs were evaluated as having 'high' RoB. There were significant associations between completeness of reporting and the following: mention of CONSORT within published RCTs (t=2.55, p=.013), length of PRO follow-up (t=2.9, p=.005; t=2.14, p=.035), and sample size (t=3.12, p=.002). No other significant associations were found.
CONCLUSION CONCLUSIONS
Our study found incomplete adherence to the CONSORT-PRO adaptation among RCTs pertaining to MS. Of the most underreported items, the failure to report a hypothesis and define an approach to missing data threaten the validity of the evidence acquired from RCTs. Furthermore, PROs provide an opportunity to supplement trial outcomes with the patient's perspective. Thus, trialists of future RCTs may improve PRO reporting with increased adherence to the CONSORT-PRO adaptation.

Identifiants

DOI: 10.1016/j.msard.2022.103819 PMID: 35487036
pubmed: 35487036
pii: S2211-0348(22)00331-5
doi: 10.1016/j.msard.2022.103819
pii:
doi:

Types de publication

Journal Article Meta-Analysis

Langues

eng

Sous-ensembles de citation

IM

Pagination

103819

Informations de copyright

Copyright © 2022 Elsevier B.V. All rights reserved.

Auteurs

Taimoor Khan (T)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States. Electronic address: taimoor.khan@okstate.edu.

Mahnoor Khalid (M)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Bryan Dunford (B)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Tiffany Nguyen (T)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Audrey Wise (A)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Benjamin Heigle (B)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Samuel Shepard (S)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Micah Kee (M)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Cody Hillman (C)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Ryan Ottwell (R)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States; Department of Internal Medicine, School of Community Medicine, University of Oklahoma, Tulsa, OK, United States.

Micah Hartwell (M)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

Matt Vassar (M)

Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Incomplete reporting of patient-reported...
questionsmedicales.fr › Maladies du système immunitaire › Maladies auto-immunes › Maladies auto-immunes du système nerveux › Maladies démyélinisantes auto-immunes du SNC › Sclérose en plaques › Incomplete reporting of patient-reported...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes sur les soins de santé › Mesures des résultats rapportés par les patients › Incomplete reporting of patient-reported...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Incomplete reporting of patient-reported...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Incomplete reporting of patient-reported...