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Clinical Study|Articles in Press

Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders

      Abstract

      Background Context

      The 6-minute walking test (6WT) has been previously shown to be a reliable and valid outcome measure. It is unclear if the 6WT may further help to detect differences in well performing patients that reach a ceiling effect in PROMs after surgery.

      Purpose

      To evaluate changes and timing of change in objective functional impairment (OFI) as measured with the smartphone-based 6WT in relation to patient-reported outcome measures (PROMs) after surgery for degenerative lumbar disorders (DLD).

      Study design

      Prospective observational cohort study.

      Patient Sample

      Fifty consecutive patients undergoing surgery for DLD.

      Outcome Measures

      Patients self-determined their OFI using the 6WT application (6WT-app) and completed a set of paper-based PROMs before, 6 weeks and 3 months after surgery.

      Methods

      Fifty patients undergoing surgery for DLD were assessed preoperatively (baseline), 6 weeks (6W) and 3 months (3M) postoperatively. Paired sample t-tests were used to establish significant changes in raw 6-minute walking distance (6WD) and standardized Z-scores, as well as PROMs. Pearson correlation coefficient was used to define the relationship between 6WT and PROMs. Floor and ceiling effects were assessed for each PROM (visual analogue scale [VAS], core outcome measure index [COMI], Zurich claudication questionnaire [ZCQ]).

      Results

      Mean 6WT results improved from 377 m (standard deviation - SD 137; Z-score: 1.8, SD 1.8) to 490 m (SD 126; -0.7, SD 1.5) and 518 m (SD 112; -0.4, SD 1.41; all p<.05) at 6W and 3M follow-up. No significant improvement was observed between 6W and 3M for the ZCQ, VAS back and leg pain. While correlation between 6WT and all PROMs were weak at baseline, correlation coefficient increased to moderate at 3M. A considerable ceiling effect (best possible score) was observed, most notably for the ZCQ physical performance, VAS back and leg pain in 24%, 20%, and 16% of patient at 6W and in 30%, 24%, and 28% at 3M.

      ConclusionS

      Objective functional tests can describe the continued change in the physical recovery of a patient and may help to detect differences in well performing groups as well as in cases where patients' PROM results cannot further improve because of a ceiling effect.

      Keywords

      Abbreviations:

      6WT (6-minute walking test), 6WD (6-minute walking distance), app (application), COMI (Core Outcome Measures Index), DLD (degenerative lumbar disorders), LDH (lumbar disc herniation), LSS (lumbar spinal stenosis), m (meters), PROMs (patient reported outcome measures), SRM (standardized responsive mean), VAS (visual analogue scale), ZCQ PF (Zurich Claudication Questionnaire Physical Function), ZCQ SS (Zurich Claudication Questionnaire Symptom Severity), COPD (chronic obstructive pulmonary disease), LBP (low back pain), SD (standard deviation)
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