Quality and reporting of patient-reported outcomes in elderly patients with hip fracture: a systematic review

Abstract

ObjectiveTo assess how patient-reported outcomes (PROs) are reported and to assess the quality of reporting PROs for elderly patients with a hip fracture in both randomised controlled trials (RCTs) and observational studies.DesignSystematic review.Data sourcesMedline, Embase and CENTRAL were searched on 1 March 2013 to 25 May 2021.Eligibility criteriaRCTs and observational studies on geriatric (≥65 years of age) patients, with one or more PRO as outcome were included.Data extraction and synthesisPrimary outcome was type of PRO; secondary outcome and quality assessment was measured by adherence to the Consolidated Standards of Reporting Trials (CONSORT) extension for patient-reported outcomes (CONSORT-PRO). Because of heterogeneity in study population and outcomes, data pooling was not possible.Results3659 studies were found in the initial search. Of those, 67 were included in the final analysis. 83.6% of studies did not adequately mention missing data, 52.3% did not correctly report how PROs were collected and 61.2% did not report adequate effect size. PRO limitations were adequately reported in 20.9% of studies and interpretation of PROs was adequately reported in 19.4% of studies. Most Quality of Life (QoL) outcomes were measured by the EuroQol 5-Dimension 3-Levels, and pain as well as patient satisfaction by Visual Analogue Scale.ConclusionThis study found that a high variety of PRO measures are used to evaluate geriatric hip fracture care. In addition, 47.8% of studies examining PROs in elderly patients with hip fracture do not satisfy at least 50% of the CONSORT-PRO criteria. This enables poorly conducted research to be published and used in evidence-based medicine and, consequently, shared decision-making. More efforts should be undertaken to improve adequate reporting. We believe extending the CONSORT-PRO extension to Strengthening the Reporting of Observational Studies in Epidemiology for observational studies would be a valuable addition to current guidelines.

Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol

“…The basic information includes (1) title, (2) authors, (3) language, (4) year, (5) journal, (6) registration, (7) single or multicentre, (8) study location, (9) sample size, (10) have efforts to determine the sample size, (11) study types (non-inferiority or inferiority), ( 12) acupuncture modality (head acupuncture, body acupuncture, electroacupuncture, etc), ( 13) randomisation sequence generation, ( 14) randomisation allocation concealment mechanism, (15) randomisation implementation, (16) randomisation concealment, (17) blinding patient, (18) blinding operator, (19) blinding evaluator, (20) intervention time, (21) intervention frequency and (22) funding.…”

“…The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network emphasised that only adequate reporting studies can provide reliable information and credible conclusions 4. But, the reporting quality of PROs in RCTs is of concern, van der Vet et al 18 found that 52.3% of RCTs did not provide the rationale for selecting PRO scales, 83.6% of RCTs did not mention missing data, while it was 44% and 72% in Brundage et al ’s study 19. Ambiguous reporting of PROs in RCTs limited the promotion and application of PRO results in clinical practices.…”