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

Anderson, DB; Mobbs, RJ; Eyles, J; Meyer, SE; Machado, GC; Davis, GA; Harris, IA; Buchbinder, R; Ferreira, ML

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

Anderson, DB

Mobbs, RJ Eyles, J Meyer, SE Machado, GC Davis, GA Harris, IA Buchbinder, R Ferreira, ML

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Publication Type:: Journal Article
Citation:: Heliyon, 2019, 5 (5)
Issue Date:: 2019-05-01

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Field	Value	Language
dc.contributor.author	Anderson, DB https://orcid.org/0000-0001-7104-122X	en_US
dc.contributor.author	Mobbs, RJ	en_US
dc.contributor.author	Eyles, J	en_US
dc.contributor.author	Meyer, SE	en_US
dc.contributor.author	Machado, GC	en_US
dc.contributor.author	Davis, GA	en_US
dc.contributor.author	Harris, IA	en_US
dc.contributor.author	Buchbinder, R	en_US
dc.contributor.author	Ferreira, ML	en_US
dc.date.issued	2019-05-01	en_US
dc.identifier.citation	Heliyon, 2019, 5 (5)	en_US
dc.identifier.issn	2405-8440	en_US
dc.identifier.uri	http://hdl.handle.net/10453/138400
dc.description.abstract	© 2019 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.	en_US
dc.relation.ispartof	Heliyon	en_US
dc.relation.isbasedon	10.1016/j.heliyon.2019.e01683	en_US
dc.title	Barriers to participation in a placebo-surgical trial for lumbar spinal stenosis	en_US
dc.type	Journal Article
utslib.citation.volume	5	en_US
utslib.for	1103 Clinical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	open_access
pubs.issue	5	en_US
pubs.publication-status	Published	en_US
pubs.volume	5	en_US

Abstract:

© 2019 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.

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http://hdl.handle.net/10453/138400