Outcome measures in chronic low back pain |
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Authors: | Elaine F Maughan Jeremy S Lewis |
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Institution: | (1) Guy’s and St Thomas’ NHS Trust, London, UK;(2) St George’s NHS Healthcare Trust, London, UK;(3) St George’s University of London, London, UK;(4) Therapy Department, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK |
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Abstract: | The purpose of this prospective, single site cohort quasi-experimental study was to determine the responsiveness of the numerical
rating scale (NRS), Roland–Morris disability questionnaire (RMDQ), Oswestry disability index (ODI), pain self-efficacy questionnaire
(PSEQ) and the patient-specific functional scale (PSFS) in order to determine which would best measure clinically meaningful
change in a chronic low back pain (LBP) population. Several patient-based outcome instruments are currently used to measure
treatment effect in the chronic LBP population. However, there is a lack of consensus on what constitutes a “successful” outcome,
how an important improvement/deterioration has been defined and which outcome measure(s) best captures the effectiveness of
therapeutic interventions for the chronic LBP population. Sixty-three consecutive patients with chronic LBP referred to a
back exercise and education class participated in this study; 48 of the 63 patients had complete data. Five questionnaires
were administered initially and after the 5-week back class intervention. Also at 5 weeks, patients completed a global impression
of change as a reflection of meaningful change in patient status. Score changes in the five different questionnaires were
subjected to both distribution- and anchor-based methods: standard error of measurement (SEM) and receiver operating characteristic
(ROC) curves to define clinical improvement. From these methods, the minimal clinically important difference (MCID) defined
as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument. Based
on the SEM, a point score change of 2.4 in the NRS, 5 in the RMDQ, 17 in the ODI, 11 on the PSEQ, and 1.4 on the PSFS corresponded
to the MCID. Based on ROC curve analysis, a point score change of 4 points for both the NRS and RMDQ, 8 points for the ODI,
9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID. The ROC analysis demonstrated that both the PSEQ
and PSFS are responsive to clinically important change over time. The NRS was found to be least responsive. The exact value
of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change. Based on ROC
curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP
following participation in a back class programme. However, due to the small sample size, the lack of observed worsening of
symptoms over time, the single centre and intervention studied these results which need to be interpreted with caution. |
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Keywords: | Low back pain Outcome measures Minimally clinically important change Responsiveness Functional assessment Clinical significance Patient-reported outcomes |
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