<p>Digital mobility outcomes (DMOs) offer unique insights into recovery of real-world mobility after proximal femoral fracture (PFF), but their clinical validity remains to be established. This study assessed construct validity (convergent, divergent, and known-groups) of 24 DMOs measuring walking activity (amount, pattern) and gait (pace, rhythm, bout-to-bout variability) in patients within one year after PFF. Patients were recruited from inpatient and outpatient lists at five European sites, resulting in 505 included participants (66% female), with mean age of 77.6 ± 9.4 years and supervised gait speed of 0.7 ± 0.4&#xa0;m/s. Mobility was monitored over seven days using a single wearable device on the lower back. Convergent and divergent validity analyses were stratified by two groups: acute (≤ 14 days since surgery) and non-acute (≥ 15 days since surgery). Correlations between DMOs and related (clinical- and patient-reported mobility outcomes) and unrelated constructs (hearing impairment and systolic blood pressure) were compared to a priori expected correlations. Known-groups validity was assessed across four recovery phases. The results were evaluated individually by experts and in a subsequent consensus meeting, with 17 of 24 DMOs showing evidence of construct validity in non-acute PFF patients. These findings represent an initial step in a larger process towards regulatory endorsement.</p>

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Construct validity of real-world digital mobility outcomes in patients after proximal femoral fracture: a cross-sectional observational study

  • Tobias Eckert,
  • Martin Aursand Berge,
  • Michael Long,
  • Martí de las Heras,
  • Paula Alvarez,
  • Hubert Blain,
  • Julia Braun,
  • Joren Buekers,
  • Brian Caulfield,
  • Monika Engdal,
  • Anja Frei,
  • Jorunn L. Helbostad,
  • Anisoara Ionescu,
  • Carl-Philipp Jansen,
  • Lars Gunnar Johnsen,
  • Jochen Klenk,
  • Sarah Koch,
  • Vita Lanfranchi,
  • Lynn Rochester,
  • Clemens Becker,
  • Beatrix Vereijken,
  • Judith Garcia-Aymerich

摘要

Digital mobility outcomes (DMOs) offer unique insights into recovery of real-world mobility after proximal femoral fracture (PFF), but their clinical validity remains to be established. This study assessed construct validity (convergent, divergent, and known-groups) of 24 DMOs measuring walking activity (amount, pattern) and gait (pace, rhythm, bout-to-bout variability) in patients within one year after PFF. Patients were recruited from inpatient and outpatient lists at five European sites, resulting in 505 included participants (66% female), with mean age of 77.6 ± 9.4 years and supervised gait speed of 0.7 ± 0.4 m/s. Mobility was monitored over seven days using a single wearable device on the lower back. Convergent and divergent validity analyses were stratified by two groups: acute (≤ 14 days since surgery) and non-acute (≥ 15 days since surgery). Correlations between DMOs and related (clinical- and patient-reported mobility outcomes) and unrelated constructs (hearing impairment and systolic blood pressure) were compared to a priori expected correlations. Known-groups validity was assessed across four recovery phases. The results were evaluated individually by experts and in a subsequent consensus meeting, with 17 of 24 DMOs showing evidence of construct validity in non-acute PFF patients. These findings represent an initial step in a larger process towards regulatory endorsement.