SynthesisEuropean respiratory review : an official journal of the European Respiratory Society2025
Selection of patient-reported outcome measures in pulmonary arterial hypertension clinical trials: a systematic review, meta-analysis and health-related quality of life framework.
Synthesis in European respiratory review : an official journal of the European Respiratory Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Psychometric Evidence for Chronic Stress Patient-Reported Outcome Measures in African American Adults: An Equity-Focused COSMIN Systematic Review.Journal of racial and ethnic health disparities · 2026Review
- The Evolving Landscape of Pulmonary Hypertension Treatment: From Vasodilation to Disease Modification.Clinical and translational science · 2026Review
- The ethical application of artificial intelligence in digital health: patients' knowledge, pulmonary hypertension, and the problem of misrecognition.European heart journal. Digital health · 2026Article
- Mediating Effects of Fear of Movement and Self-Efficacy Between Illness Perception and Health-Related Quality of Life in Pulmonary Hypertension.Psychology research and behavior management · 2026Article
- Comparability, acceptability and longitudinal adherence with digital emPHasis-10 in pulmonary arterial hypertension.The European respiratory journal · 2025Article
Corrections and comments
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Authors and funding
16 authors.
Funding
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Abstract
introductionHealth-related quality of life (HRQoL) in pulmonary arterial hypertension (PAH) is valued as an outcome measure by patients, clinicians and regulators. The selection of patient-reported outcome measures (PROMs) for measurement of HRQoL in PAH clinical trials lacks systematic evaluation of their suitability, accuracy and reliability.
methodsWe report a systematic review (PROSPERO ID: CRD42024484021) following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines of PROMs selected in PAH clinical trials. PROM measurement properties were then evaluated according to the 10-step COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and graded by recommendation for use. Finally, HRQoL was modelled into a conceptual framework using patient interviews and surveys.
resultsScreening of 896 records identified 90 randomised controlled trials. 43 trials selected PROMs, of which 20 were sufficiently validated to detect meaningful change. Of these, eight trials were adequately powered, using either EuroQol-five dimensions-five levels (EQ-5D-5L), Short-Form-36 (SF-36) or the Living with Pulmonary Hypertension Questionnaire (LPHQ). The COSMIN evaluation recommended EmPHasis-10 and the LPHQ for use (grade A); whereas, SF-36 and EQ-5D-5L require further study (grade B). A conceptual framework of HRQoL was developed from literature comprising 8045 patients. This framework can be used to visualise the different HRQoL concepts measured by different PROMs.
conclusionTo improve patient-centred research, greater consistency in PROM selection is required. Three of 90 randomised controlled trials have selected COSMIN-recommended PROMs. Whilst the PROMs evaluated require development across the 10 areas of psychometric property measurement, EmPHasis-10 and the LPHQ can be recommended for use. The ratified conceptual framework can further support PROM selection by identifying the HRQoL concepts they are likely to capture.
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