Article type
Year
Abstract
Background: The field of spine surgery undergoes rapid introduction of new surgical techniques. The effectiveness or efficacy of these new techniques needs to be evaluated in rigorous randomized clinical trials to support their use.
Objectives: To evaluate the methodological quality in surgery trials of the cervical and lumbar spine to enhance awareness and endorsement of bias avoidance and reporting recommendations of surgery trials.
Methods: A risk of bias assessment was conducted on all included studies in systematic reviews of surgical interventions in patients with neck and low back pain by two reviewers independently using the assessment form of the Cochrane Back Review Group. A study was defined as having a low risk of bias when fulfilling six or more of the items. A descriptive analysis was performed.
Results: In total, 90 RCTs were identified in three systematic reviews comparing different surgical interventions with conventional treatment or other surgical interventions. Of these studies only a few trials had a low risk of bias, and most of them were published between 2007-2009. The items that scored positive in most studies were adequate randomisation, acceptable drop-out rate and timing of outcome assessment. The most common items that were unclear or scored negatively included the concealment of allocation, blinding of patients, care provider or outcome assessor and the implementation of intention-to-treat analysis.
Conclusions: The quality of RCTs on surgical interventions in the cervical and lumbar spine file has increased over time, but is still poor and shows room for improvement. Improvement can be reached by paying more attention to the randomisation procedure (concealment), co-interventions, preventing withdrawals and the analysis (intention to treat).
Objectives: To evaluate the methodological quality in surgery trials of the cervical and lumbar spine to enhance awareness and endorsement of bias avoidance and reporting recommendations of surgery trials.
Methods: A risk of bias assessment was conducted on all included studies in systematic reviews of surgical interventions in patients with neck and low back pain by two reviewers independently using the assessment form of the Cochrane Back Review Group. A study was defined as having a low risk of bias when fulfilling six or more of the items. A descriptive analysis was performed.
Results: In total, 90 RCTs were identified in three systematic reviews comparing different surgical interventions with conventional treatment or other surgical interventions. Of these studies only a few trials had a low risk of bias, and most of them were published between 2007-2009. The items that scored positive in most studies were adequate randomisation, acceptable drop-out rate and timing of outcome assessment. The most common items that were unclear or scored negatively included the concealment of allocation, blinding of patients, care provider or outcome assessor and the implementation of intention-to-treat analysis.
Conclusions: The quality of RCTs on surgical interventions in the cervical and lumbar spine file has increased over time, but is still poor and shows room for improvement. Improvement can be reached by paying more attention to the randomisation procedure (concealment), co-interventions, preventing withdrawals and the analysis (intention to treat).