Barriers to participation in a placebo-surgical trial for lumbar spinal stenosis

David B Anderson; Ralph J Mobbs; Jillian Eyles; S Eileen Meyer; Gustavo C Machado; Gavin A Davis; Ian A Harris; Rachelle Buchbinder; Manuela L Ferreira

doi:10.1016/j.heliyon.2019.e01683

Barriers to participation in a placebo-surgical trial for lumbar spinal stenosis

Heliyon. 2019 May 20;5(5):e01683. doi: 10.1016/j.heliyon.2019.e01683. eCollection 2019 May.

Authors

David B Anderson¹, Ralph J Mobbs², Jillian Eyles¹, S Eileen Meyer³, Gustavo C Machado⁴, Gavin A Davis⁵, Ian A Harris⁶, Rachelle Buchbinder⁷, Manuela L Ferreira¹

Affiliations

¹ Institute of Bone and Joint Research, The Kolling Institute, Sydney Medical School, The University of Sydney, Sydney, Australia.
² Department of Neurosurgery, Prince of Wales Private Hospital, Sydney; Neuro Spine Clinic, Randwick; University of New South Wales, Kensington, New South Wales, Australia.
³ Hanover Medical School, Hanover, Germany.
⁴ Sydney School of Public Health, Sydney Medical School, The University of Sydney; and Institute for Musculoskeletal Health, Royal Prince Alfred Hospital, Sydney Local Health District, Sydney, New South Wales, Australia.
⁵ Neurosurgery Department, Cabrini and Austin Hospitals, Melbourne, Victoria, Australia.
⁶ Ingham Institute of Applied Medical Research, South Western Sydney Clinical School, UNSW, Sydney, Australia.
⁷ Monash Department of Clinical Epidemiology, Cabrini Institute; and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Abstract

Background: Placebo-controlled trials are an important tool when assessing the efficacy of spinal surgical procedures. The most common spinal surgical procedure in older adults is decompression for lumbar spinal stenosis. Before conducting a placebo-surgical trial on decompression surgery, an investigation of patients' willingness to participate in a placebo-controlled trial of decompression surgery and barriers to participation were explored.

Materials: An online survey.

Methods: Descriptive analyses of demographic and clinical data, and participants' willingness to participate in a placebo-surgical trial. Logistic regression was used to examine potential predictors of willingness to participate. Two independent researchers performed a coded framework analysis of patients' barriers to participation.

Results: 68 patients were invited and 63 participants completed the survey (91.3% response, mean (SD) age 69.5 (10.9) years, 52% females), 71% suffered from moderate to very severe pain. Ten participants (15.9%) were willing to participate in a placebo-controlled trial. Being married was associated with decreased odds of participating (OR: 0.2; 95% CI, 0.05 to 0.8; P = 0.03), while the main barriers were a lack of information about the procedure, reassurance of a positive outcome with participation, and concerns about the risks and benefits of placebo surgery.

Conclusions: A minority of patients with lumbar spinal stenosis were willing to participate in a placebo-controlled trial of surgery. The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial. Conclusions should be read cautiously however, given the small sample size present in this study.

Keywords: Surgery.