Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression
Abstract Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decomp...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-12-01
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| Series: | Trials |
| Online Access: | https://doi.org/10.1186/s13063-023-07772-5 |
| _version_ | 1827590349959200768 |
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| author | Emma Kwan-Yee Ho Ralph Jasper Mobbs James Montague van Gelder Ian Andrew Harris Gavin Davis Ralph Stanford David John Beard Christopher Gerard Maher Joanna Prior Michael Knox David Barrett Anderson Rachelle Buchbinder Manuela Loureiro Ferreira |
| author_facet | Emma Kwan-Yee Ho Ralph Jasper Mobbs James Montague van Gelder Ian Andrew Harris Gavin Davis Ralph Stanford David John Beard Christopher Gerard Maher Joanna Prior Michael Knox David Barrett Anderson Rachelle Buchbinder Manuela Loureiro Ferreira |
| author_sort | Emma Kwan-Yee Ho |
| collection | DOAJ |
| description | Abstract Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature. |
| first_indexed | 2024-03-09T01:15:38Z |
| format | Article |
| id | doaj.art-6b94e9d615924914939aaf56891f9f04 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T01:15:38Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6b94e9d615924914939aaf56891f9f042023-12-10T12:30:38ZengBMCTrials1745-62152023-12-0124111110.1186/s13063-023-07772-5Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompressionEmma Kwan-Yee Ho0Ralph Jasper Mobbs1James Montague van Gelder2Ian Andrew Harris3Gavin Davis4Ralph Stanford5David John Beard6Christopher Gerard Maher7Joanna Prior8Michael Knox9David Barrett Anderson10Rachelle Buchbinder11Manuela Loureiro Ferreira12The University of Sydney, Sydney Musculoskeletal Health, Charles Perkins Centre, Faculty of Medicine and Health, School of Health SciencesNeuroSpine Surgery Reserach Group (NSURG)Department of Neurosurgery, Concord Repatriation General HospitalSouth West Sydney Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, University of New South WalesNeurosurgery, Cabrini & Austin Hospitals; and School of Public Health and Preventive Medicine, Monash UniversityPrince of Wales HospitalThe University of Sydney, Sydney Musculoskeletal Health, Charles Perkins Centre, Faculty of Medicine and Health, School of Health SciencesThe University of Sydney, Sydney Musculoskeletal HealthThe University of Sydney, School of Health Sciences, Faculty of Medicine and HealthThe University of Sydney, Sydney Musculoskeletal Health and the Kolling Institute, Faculty of Medicine and Health, School of Health Sciences, Northern Sydney Local Health DistrictSchool of Public Health and Preventive Medicine, Monash UniversityMusculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash UniversityThe University of Sydney, Sydney Musculoskeletal Health and the Kolling Institute, Faculty of Medicine and Health, School of Health Sciences, Northern Sydney Local Health DistrictAbstract Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.https://doi.org/10.1186/s13063-023-07772-5 |
| spellingShingle | Emma Kwan-Yee Ho Ralph Jasper Mobbs James Montague van Gelder Ian Andrew Harris Gavin Davis Ralph Stanford David John Beard Christopher Gerard Maher Joanna Prior Michael Knox David Barrett Anderson Rachelle Buchbinder Manuela Loureiro Ferreira Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression Trials |
| title | Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression |
| title_full | Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression |
| title_fullStr | Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression |
| title_full_unstemmed | Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression |
| title_short | Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression |
| title_sort | challenges of conducting a randomised placebo controlled trial of spinal surgery the success trial of lumbar spine decompression |
| url | https://doi.org/10.1186/s13063-023-07772-5 |
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