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ORIGINAL ARTICLE
REPORTING OF PATIENT-REPORTED OUTCOMES IN RCTS FOCUSED ON TINNITUS: A META STUDY
1
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, United States
2
Department of Internal Medicine, University of Oklahoma, School of Community Medicine, United States
3
Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, United States
A - Research concept and design; B - Collection and/or assembly of data; C - Data analysis and interpretation; D - Writing the article; E - Critical revision of the article; F - Final approval of article;
Submission date: 2022-04-14
Final revision date: 2022-07-19
Acceptance date: 2022-07-22
Publication date: 2022-09-30
Corresponding author
Rigel Bacani
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 West 17th Street, 74107, Tulsa, United States
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 West 17th Street, 74107, Tulsa, United States
J Hear Sci 2022;12(3):33-40
KEYWORDS
TOPICS
ABSTRACT
Background:
The inclusion of patient-reported outcomes (PROs) in randomized controlled trials (RCTs) supplements outcomes of treatment efficacy with the patient’s perspectives. The aim of this study was to evaluate reporting completeness of PROs in RCTs pertaining to tinnitus, using the Consolidated Standards of Reporting Trials (Consort-PRO) adaptation.
Material and methods:
We performed a search of Medline, Embase, and Cochrane Central Register of Controlled Trials (Central) for published RCTs related to tinnitus with at least one PRO measure from 2006 to 2020. Two investigators screened RCTs for inclusion. Using the Consort-PRO adaptation in an independent, masked fashion, investigators then evaluated all included RCTs. Similarly, all RCTs were evaluated using the Cochrane Collaboration Risk of Bias 2.0 tool. To assess relationships between trial characteristics and completeness of reporting, bivariate regression analyses were used.
Results:
From 878 publications, 37 RCTs met inclusion criteria. The mean Consort-PRO completeness of reporting across RCTs was 51.2% (SD = 20.8). Evaluation of our secondary outcome – assessment of study characteristics – demonstrated significantly higher completeness of reporting when (1) the Consort guideline was mentioned within the RCT (p = 0.01); (2) trials had ‘some concerns’ for bias (p = 0.001); and (3) trials had ‘low’ risk of bias (p = 0.001).
Conclusions:
Our study found that there was subpar Consort-PRO adherence within tinnitus RCTs. Due to the variance in symptom severity in tinnitus and the importance of PROs to clinical practice, we recommend journals include instructions to authors to use the Consort-PRO guideline before they publish RCTs.
The inclusion of patient-reported outcomes (PROs) in randomized controlled trials (RCTs) supplements outcomes of treatment efficacy with the patient’s perspectives. The aim of this study was to evaluate reporting completeness of PROs in RCTs pertaining to tinnitus, using the Consolidated Standards of Reporting Trials (Consort-PRO) adaptation.
Material and methods:
We performed a search of Medline, Embase, and Cochrane Central Register of Controlled Trials (Central) for published RCTs related to tinnitus with at least one PRO measure from 2006 to 2020. Two investigators screened RCTs for inclusion. Using the Consort-PRO adaptation in an independent, masked fashion, investigators then evaluated all included RCTs. Similarly, all RCTs were evaluated using the Cochrane Collaboration Risk of Bias 2.0 tool. To assess relationships between trial characteristics and completeness of reporting, bivariate regression analyses were used.
Results:
From 878 publications, 37 RCTs met inclusion criteria. The mean Consort-PRO completeness of reporting across RCTs was 51.2% (SD = 20.8). Evaluation of our secondary outcome – assessment of study characteristics – demonstrated significantly higher completeness of reporting when (1) the Consort guideline was mentioned within the RCT (p = 0.01); (2) trials had ‘some concerns’ for bias (p = 0.001); and (3) trials had ‘low’ risk of bias (p = 0.001).
Conclusions:
Our study found that there was subpar Consort-PRO adherence within tinnitus RCTs. Due to the variance in symptom severity in tinnitus and the importance of PROs to clinical practice, we recommend journals include instructions to authors to use the Consort-PRO guideline before they publish RCTs.
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