Abstract

PurposePatient- and clinician-reported outcome measures (PROMs, CROMs) are used in rehabilitation to evaluate and track the patient’s health status and recovery. However, controversy still exists regarding their relevance and validity when assessing a change in health status.MethodsWe retrospectively analyzed the changes in a CROM (Fingertip-To-Floor Test – FTF) and PROMs (ODI, HAQ-DI, NPRS, EQ5D) and the associations between these outcomes in 395 patients with lower back pain (57.2 ± 11.8 years, 49.1% female). We introduced a new way to measure and classify outcome performance using a distribution-based approach (t2D). Outcome measures were assessed at baseline and after 21 days of inpatient rehabilitation.ResultsOverall, the rehabilitation (Cohens d = 0.94) resulted in a large effect size outcome. Medium effect sizes were observed for FTF (d = 0.70) and PROMs (d > 0.50). Best performance rating was observed for pain (NPRS). We found that 13.9% of patients exhibited a deterioration in the PROMs, but only 2.3%, in the FTF. The correlation between the PROMs and FTF were low to moderate, with the highest identified for HAQ-DI (rho = 0.30–0.36); no significant correlations could be shown for changes. High consistency levels were observed among the performance scores (t2D) in 68.9% of the patients.ConclusionsDifferent and complementary assessment modalities of PROMs and CROMs can be used as valuable tools in the clinical setting. Results from both types of measurements and individual performance assessments in patients provide a valid basis for the meaningful interpretation of the patients’ health outcomes.Trial registration. This clinical study was entered retrospectively on August 14, 2020 into the German Clinical Trials Register (DRKS, registration number: DRKS00022854).

Highlights

  • Low back pain (LBP) is highly prevalent in the general population [1] and has been ranked sixth globally in terms of overall disease burden [2]

  • Effect sizes were interpreted according to Cohen [36], while correlations between clinician-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs) were determined using Spearman’s rank correlation coefficients, Pearson product-moment correlations (r) or linear regression models for t1, t2, changes (Δ) and performance scores (t2 + Δ)

  • The difference between the standardized performance (z-)scores of PROMs and CROMs was calculated to show the level of consistency

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Summary

Introduction

Low back pain (LBP) is highly prevalent in the general population [1] and has been ranked sixth globally in terms of overall disease burden [2]. Exercise therapy, which is often prescribed for LBP, has been found to positively affect pain levels, as well as physical functioning in LBP patients [3]. It is still unclear whether subjective, patient-reported outcome measures (PROMs) reflect the actual course of convalescence in LBP rehabilitation, if this is better achieved by applying objective, clinician-reported outcome measures (CROMs) alone, or if a combination of PROMs and CROMs should be applied. The Fingertip-to-Floor test (FTF) and the Schoeber test represent commonly used CROMs which have been validated for the LBP patient population [11, 12]

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