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.

Department of Neurosurgery Kantonsspital St Gallen St Gallen Switzerland

Department of Neurosurgery Kantonsspital St Gallen St Gallen Switzerland; 1 Faculty of Medicine Charles University Prague Prague Czech Republic; Faculty of Medicine University of Zurich Zurich Switzerland

Department of Neurosurgery Kantonsspital St Gallen St Gallen Switzerland; Department of Neurosurgery University Hospital Zurich and Clinical Neuroscience Center University of Zurich Zurich Switzerland

Department of Neurosurgery Kantonsspital St Gallen St Gallen Switzerland; Department of Neurosurgery University Hospital Zurich and Clinical Neuroscience Center University of Zurich Zurich Switzerland; Faculty of Medicine University of Zurich Zurich Switzerland

Department of Neurosurgery Stanford University Hospital and Clinics Stanford CA USA

Department of Neurosurgery University Hospital Zurich and Clinical Neuroscience Center University of Zurich Zurich Switzerland

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External validation of the smartphone-based 6-minute walking test in patients with degenerative lumbar disorders undergoing epidural steroid injection

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ClinicalTrials.gov
NCT03977961