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What is an acceptable outcome of treatment before it begins? Methodological considerations and implications for patients with chronic low back pain

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Abstract

Understanding changes in patient-reported outcomes is indispensable for interpretation of results from clinical studies. As a consequence the term “minimal clinically important difference” (MCID) was coined in the late 1980s to ease classification of patients into improved, not changed or deteriorated. Several methodological categories have been developed determining the MCID, however, all are subject to weaknesses or biases reducing the validity of the reported MCID. The objective of this study was to determine the reproducibility and validity of a novel method for estimating low back pain (LBP) patients’ view of an acceptable change (MCIDpre) before treatment begins. One-hundred and forty-seven patients with chronic LBP were recruited from an out-patient hospital back pain unit and followed over an 8-week period. Original and modified versions of the Oswestry disability index (ODI), Bournemouth questionnaire (BQ) and numeric pain rating scale (NRSpain) were filled in at baseline. The modified questionnaires determined what the patient considered an acceptable post-treatment outcome which allowed us to calculate the MCIDpre. Concurrent comparisons between the MCIDpre, instrument measurement error and a retrospective approach of establishing the minimal clinically important difference (MCIDpost) were made. The results showed the prospective acceptable outcome method scores to have acceptable reproducibility outside measurement error. MCIDpre was 4.5 larger for the ODI and 1.5 times larger for BQ and NRSpain compared to the MCIDpost. Furthermore, MCIDpre and patients post-treatment acceptable change was almost equal for the NRSpain but not for the ODI and BQ. In conclusion, chronic LBP patients have a reasonably realistic idea of an acceptable change in pain, but probably an overly optimistic view of changes in functional and psychological/affective domains before treatment begins.

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Acknowledgments

We thank Jytte Johannesen and Ida Bhanderi for administering the questionnaires. Furthermore, we would like to thank the management and staff at Backcenter Funen for their enthusiastic participation in the project. A special thanks to the seven chiropractic clinics for their involvement in recruiting patients for the study. The study was supported by the Foundation of Chiropractic Research and Postgraduate Education, The Faculty of Health Science at the University of Southern Denmark and The European Chiropractic Union.

Conflict of interest statement

The funding bodies have no control over design, conduct, data, analysis, review, reporting, or interpretation of the research conducted with the funds.

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Authors and Affiliations

  1. Clinical Locomotion Science, Institute for Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark

    Henrik Hein Lauridsen, Lars Korsholm, Niels Grunnet-Nilsson & Jan Hartvigsen

  2. Nordic Institute of Chiropractic and Clinical Biomechanics, Part of Clinical Locomotion Science, Odense, Denmark

    Jan Hartvigsen

  3. Department of Statistics, University of Southern Denmark, Odense, Denmark

    Lars Korsholm

  4. Backcenter Funen, Part of Clinical Locomotion Science, Ringe, Denmark

    Claus Manniche

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  1. Henrik Hein Lauridsen
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Correspondence to Henrik Hein Lauridsen.

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Lauridsen, H.H., Manniche, C., Korsholm, L. et al. What is an acceptable outcome of treatment before it begins? Methodological considerations and implications for patients with chronic low back pain. Eur Spine J 18, 1858–1866 (2009). https://doi.org/10.1007/s00586-009-1070-1

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