What patient reported outcome measures are used in clinical trials in hip fracture? A systematic mapping review

TL;DR

This study reviews which patient-reported outcome measures are used in hip fracture clinical trials, finding that many are used but often lack validation evidence.

Contribution

The study systematically maps PROM usage in hip fracture trials and identifies gaps in validation evidence and standardization.

Findings

28 different PROMs were used across 189 hip fracture trials, with Harris hip score, EuroQoL-5D, and pain visual analogue scale being most common.

85.7% of studies used at least one PROM, and 95 studies did not reference validity evidence for the PROMs used.

There is an increasing trend in PROM usage over time, including as primary outcomes, but no single PROM covers all outcome domains.

Abstract

Patient-reported outcome measures (PROMs) are increasingly used to assess treatment effectiveness in various domains from the patients’ perspective. This systematic review aimed to identify what PROMs have been used in hip fracture clinical trials, whether they are used as the primary outcome, whether validity evidence is referenced and how their use has changed over time.

Studies obtained from PubMed, Embase, and Web of Science published between 01/01/2010 and 29/09/2025 were assessed. Eligible studies were controlled trials on hip fracture interventions in adult populations published in English. We checked the reference for validity evidence of PROMs used in included studies. Characteristics of each study were extracted, and PROMs usage was summarised by year of publication.

A total of 28 different PROMs were used in 189 trials, with each covering different outcome domains. The most used PROMs were Harris hip score, EuroQoL-5D and pain visual analogue scale. A predominant proportion of studies (n = 162, 85.7%) utilised at least one PROMs, including 65 studies used multiple PROMs. There is an increasing trend of PROMs usage in trials and the number of papers using a PROM as a primary outcome over time. However, 95 studies did not reference any validity evidence for PROMs used.

The frequent usage of PROMs in trials, and often as a primary outcome, suggests patient perspective is valued when evaluating hip fracture intervention. However, the lack of a single PROM covering all outcome domains necessitates using more than one PROMs in the included trials. A more comprehensive PROM or a core set of PROMs that measures all patient-related outcomes would achieve a holistic assessment and the ability to make direct comparisons between different interventions.

The online version contains supplementary material available at 10.1186/s12891-025-09456-4.

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