Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization

Brock, Lydia; Hightower, Brooke; Moore, Ty; Nees, Danya; Heigle, Benjamin; Shepard, Samuel; Kee, Micah; Ottwell, Ryan; Hartwell, Micah; Vassar, Matt

doi:10.1016/j.asmr.2022.04.032

Cited by 2 publications

(2 citation statements)

References 38 publications

(60 reference statements)

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“…PRO-specific limitations and implications for generalizability and clinical practice were well reported in 18.97% of all RCTs of depression included in our study. This proportion was similar to that of the studies on multiple myeloma examined in another review (28) but was much lower than that of the 71 RCTs of hematological malignancies (25). More efforts should be made to improve the quality of reporting because it is helpful for clinicians and patients to assess treatment tolerability and make therapeutic decisions.…”

Section: Discussionsupporting

confidence: 63%

“…Importantly, as an integral part of PRO analysis and interpretation, handling missing data is inevitably, but about half of the articles included in this study did not state their statistical approaches for dealing with missing data completely. A systematic review assessing PRO reporting in studies on multiple myeloma found that only 23.0% reported a statistical plan for handling missing data (28). In another review of PRO reporting in randomized controlled trials of hematological malignancies, the proportion of missing data was reported in 51 (72%) of the 71 RCTs, but approaches used to handle missing data were described in only 26 (37%) trials (25).…”

Section: Discussionmentioning

confidence: 99%

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Low-quality of patient-reported outcome reporting in randomized clinical trials of major depressive disorder—a meta-epidemiological review

Zhou,

Qi,

et al. 2023

Front. Psychiatry

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ObjectiveOur goal was to review current peer-reviewed articles in which the BDI (Beck Depression Inventory), PHQ-9 (Patient Health Questionnaire), or QIDS-SR16 (16-Item Quick Inventory of Depressive Symptomatology) was used as the primary or secondary outcome measure and to evaluate the quality of PRO (Patient-Reported Outcome) reporting in RCTs (Randomized Controlled Trials) according to the 2013 PRO-specific CONSORT (Consolidated Standards of Reporting Trials) extension.MethodsWe systematically searched in electronic databases. A study would be included if it included patients diagnosed with major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases, version 10 (ICD-10) as participants, was a randomized controlled trial, included the BDI, PHQ-9, or QIDS-SR16 as the primary or secondary outcome measure, published between 1990 and 2013, and was in English. Two of the authors evaluated the quality of PRO reporting according to the 2013 CONSORT-PRO. Logistic regression were used to evaluate the association between reporting completeness and trial characteristics.ResultsA total of 116 studies were included. These studies were conducted in 25 countries. Sample sizes ranged from 12 to 750. The CONSORT-PRO was not cited in any one of the included studies. Among the 116 studies, 2 (1.72%) studies introduced the rationale for PRO assessment, 60 (51.72%) studies explicitly stated statistical approaches for dealing with missing data, 87 (75.00%) studies reported PRO outcome data at baseline and at subsequent time points. The mean score of reporting completeness was 66.24%. Significantly higher reporting completeness was found for RCTs published after 2013 (OR, 95%CI: 3.81, 1.32–10.99). Studies with a higher sample size were more completely reported than studies with a lower sample size (OR, 95%CI: 1.01, 1.00–1.02).ConclusionThe CONSORT-PRO guidance was rarely cited. The quality of PRO reporting in depression studies requires improvement. This result may be meaningful for the promotion of PRO reporting in RCTs.

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Section: Discussionsupporting

confidence: 63%

Section: Discussionmentioning

confidence: 99%