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Primum non nocere : shared informed decision making in low back pain : a pilot cluster randomised trial
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Patel, Shilpa, Ngunjiri, Anne, Hee, Siew Wan, Yang, Yaling, Brown, Sally, Friede, Tim, Griffiths, Frances, Lord, J., Sandhu, Harbinder, Thistlethwaite, Jill, Tysall, Colin and Underwood, Martin (2014) Primum non nocere : shared informed decision making in low back pain : a pilot cluster randomised trial. BMC Musculoskeletal Disorders, 15 . 282 . doi:10.1186/1471-2474-15-282 ISSN 1471-2474.
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Official URL: http://dx.doi.org/10.1186/1471-2474-15-282
Abstract
Background
Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments.
Methods
This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into “satisfaction” (very satisfied or somewhat satisfied) and “non-satisfaction” (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied).
Results
We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%.
Conclusion
We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.
| Item Type: | Journal Article | ||||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Backache -- Treatment, Clinical medicine -- Decision making, Decision support systems | ||||||||
| Journal or Publication Title: | BMC Musculoskeletal Disorders | ||||||||
| Publisher: | Biomed Central | ||||||||
| ISSN: | 1471-2474 | ||||||||
| Official Date: | 21 August 2014 | ||||||||
| Dates: |
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| Volume: | 15 | ||||||||
| Article Number: | 282 | ||||||||
| DOI: | 10.1186/1471-2474-15-282 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||
| Date of first compliant deposit: | 28 December 2015 | ||||||||
| Date of first compliant Open Access: | 28 December 2015 | ||||||||
| Funder: | National Institute for Health Research (Great Britain) (NIHR), Birmingham Science City, Advantage West Midlands (AWM), Wolfson Foundation (WF) |
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