Concerns about the Responsiveness of Generic Measures and the Search for a “Minimally” Important Change: Today’s PRO Red Herrings

Cella, David

doi:10.1007/s40271-022-00590-y

Cited by 1 publication

(1 citation statement)

References 4 publications

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“…When PROMs are used as the primary outcome in a clinical trial, the identification and quantification of subtle changes due to treatment are critical since the success or failure of the trial depends entirely on the PROM. It is therefore essential that the PROM be responsive to small, but important, changes to determine if the treatment is effective or potentially harmful [ 46 ]. As discussed earlier, universal (a.k.a.…”

Section: Discussionmentioning

confidence: 99%

Patient-reported outcome measures for primary hyperparathyroidism: a systematic review of measurement properties

Liang,

Kaur,

Wade

et al. 2024

Health Qual Life Outcomes

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Background The quality of patient-reported outcome measures (PROMs) used to assess the outcomes of primary hyperparathyroidism (PHPT), a common endocrine disorder that can negatively affect patients’ health-related quality of life due to chronic symptoms, has not been rigorously examined. This systematic review aimed to summarize and evaluate evidence on the measurement properties of PROMs used in adult patients with PHPT, and to provide recommendations for appropriate measure selection. Methods After PROSPERO registration (CRD42023438287), Medline, EMBASE, CINAHL Complete, Web of Science, PsycINFO, and Cochrane Trials were searched for full-text articles in English investigating PROM development, pilot studies, or evaluation of at least one PROM measurement property in adult patients with any clinical form of PHPT. Two reviewers independently identified studies for inclusion and conducted the review following the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) Methodology to assess risk of bias, evaluate the quality of measurement properties, and grade the certainty of evidence. Results From 4989 records, nine PROM development or validation studies were identified for three PROMs: the SF-36, PAS, and PHPQoL. Though the PAS demonstrated sufficient test-retest reliability and convergent validity, and the PHPQoL sufficient test-retest reliability, convergent validity, and responsiveness, the certainty of evidence was low-to-very low due to risk of bias. All three PROMs lacked sufficient evidence for content validity in patients with PHPT. Conclusions Based upon the available evidence, the SF-36, PAS, and PHPQoL cannot currently be recommended for use in research or clinical care, raising important questions about the conclusions of studies using these PROMs. Further validation studies or the development of more relevant PROMs with strong measurement properties for this patient population are needed.

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Section: Discussionmentioning

confidence: 99%