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Primum non nocere: shared informed decision making in low back pain-a pilot cluster randomised trial

Primum non nocere: shared informed decision making in low back pain-a pilot cluster randomised trial
Primum non nocere: shared informed decision making in low back pain-a pilot cluster randomised trial
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 ( pound38 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 pound20,000 per QALY was 16%.

Conclusions: 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
back pain, randomised control trial, decision making
282
Patel, S.
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Ngunjiri, A.
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Hee, S.W.
73ca3ccf-6207-4d29-953d-2387c8c59103
Yang, Y.
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Brown, S.
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Friede, T.
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Griffiths, F.
a9fd1575-07f0-4d10-964f-3285d9287c31
Lord, J.
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Sandhu, H.
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Thistlethwaite, J.
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Tysall, C.
bff0e89c-729d-4720-a1bc-7e54d43b9355
Underwood, M.
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Patel, S.
78768815-0cdc-4ece-afc4-c8cb77fd760d
Ngunjiri, A.
052a9ed3-68a8-4171-a403-da386b643f9e
Hee, S.W.
73ca3ccf-6207-4d29-953d-2387c8c59103
Yang, Y.
0c661323-7e23-41c6-a9a2-b4479fd74ef1
Brown, S.
f49b5c22-c165-4452-907a-43be551927e1
Friede, T.
5727e338-897c-4dde-877f-8fccb27d4e30
Griffiths, F.
a9fd1575-07f0-4d10-964f-3285d9287c31
Lord, J.
fd3b2bf0-9403-466a-8184-9303bdc80a9a
Sandhu, H.
da7071a2-9274-4e67-921f-19ab5a97b2f5
Thistlethwaite, J.
fe968bc5-eba8-498f-9346-d0f03f5a1075
Tysall, C.
bff0e89c-729d-4720-a1bc-7e54d43b9355
Underwood, M.
0d1c37b5-170a-4883-9851-0727dcb729bd

Patel, S., Ngunjiri, A., Hee, S.W., Yang, Y., Brown, S., Friede, T., Griffiths, F., Lord, J., Sandhu, H., Thistlethwaite, J., Tysall, C. and Underwood, M. (2014) Primum non nocere: shared informed decision making in low back pain-a pilot cluster randomised trial. BMC Musculoskeletal Disorders, 15 (282), 282. (doi:10.1186/1471-2474-15-282). (PMID:25146587)

Record type: Article

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 ( pound38 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 pound20,000 per QALY was 16%.

Conclusions: 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

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Accepted/In Press date: 29 July 2014
Published date: 21 August 2014
Keywords: back pain, randomised control trial, decision making
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 382207
URI: https://eprints.soton.ac.uk/id/eprint/382207
PURE UUID: c4288dda-1589-4cd7-87f6-2c02f63e45e4
ORCID for J. Lord: ORCID iD orcid.org/0000-0003-1086-1624

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Date deposited: 18 Jan 2016 14:01
Last modified: 20 Jul 2019 00:34

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