Hidden influence? Unmasking conflicts of interest from randomized clinical trials on spinal cord stimulation for chronic pain.

BACKGROUND: Randomized clinical trials (RCTs) are considered the gold standard for evaluating the efficacy of healthcare interventions. However, conflicts of interest (COIs) can compromise the scientific integrity in these trials. This study characterized COIs in RCTs on spinal cord stimulation for chronic pain, focusing on the prevalence, disclosure, and monetary value of COIs. METHODS: This cross-sectional study analyzed RCTs published from January 1, 2013 to July 27, 2023. Primary outcomes included the presence, disclosure, and monetary value of COIs, while secondary outcomes assessed the presence of direct/indirect COIs, sponsor access to data, and associations between COIs and select variables, including journal impact factor, publication year, and study outcomes. RESULTS: Of 38 RCTs, 30 (78.9%) reported COIs. On average, 35.6% of authors per RCT had at least one COI, with a mean of 0.7 COIs per author. The mean annual monetary value of COIs was US$41,157.83 per author per RCT. 29 RCTs (76.3%) had undisclosed COIs, with an average of 24.2% of authors per RCT having undisclosed COIs. Sponsor access to data was reported in 67.6% of RCTs. No associations were observed between the mean percentage of authors with COIs and the monetary value of COIs and select dependent variables (impact factor, publication year, and study outcomes). CONCLUSIONS: A substantial majority of RCTs reported COIs with many authors having undisclosed conflicts, highlighting the need for stringent COI disclosure guidelines to maintain research integrity. Expanding COI registry systems globally and increasing non-industry funding are crucial steps toward enhancing transparency and reducing biases in medical research.

Methodological and statistical characteristics of meta-analyses on spinal cord stimulation for chronic pain: a systematic review.

BACKGROUND: A growing number of meta-analyses (MA) have investigated the use of spinal cord stimulation (SCS) as a treatment modality for chronic pain. The quality of these MAs has not been assessed by validated appraisal tools. OBJECTIVE: To examine the methodological characteristics and quality of MAs related to the use of SCS for chronic pain syndromes. EVIDENCE REVIEW: An online literature search was conducted in Ovid MEDLINE(R), Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, and Scopus databases (January 1, 2000 through June 30, 2023) to identify MAs that investigated changes in pain intensity, opioid consumption, and/or physical function after SCS for the treatment of chronic pain. MA quality was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR-2) critical appraisal tool. FINDINGS: Twenty-five MAs were appraised in the final analysis. Three were considered "high" quality, three "low" quality, and 19 "critically low" quality, per the AMSTAR-2 criteria. There was no association between the publication year and AMSTAR-2 overall quality (ß 0.043; 95% CI -0.008 to 0.095; p=0.097). There was an association between the impact factor and AMSTAR-2 overall quality (ß 0.108; 95% CI 0.044 to 0.172; p=0.002), such that studies published in journals with higher impact factors were associated with higher overall quality. There was no association between the effect size and AMSTAR-2 overall quality (ß -0.168; 95% CI -0.518 to 0.183; p=0.320).According to our power analysis, three studies were adequately powered (>80%) to reject the null hypothesis, while the remaining studies were underpowered (<80%). CONCLUSIONS: The study demonstrates a critically low AMSTAR-2 quality for most MAs published on the use of SCS for treating chronic pain. Future MAs should improve study quality by implementing the AMSTAR-2 checklist items. PROSPERO REGISTRATION NUMBER: CRD42023431155.

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis.

BACKGROUND: Spinal cord stimulation (SCS) has emerged as an important treatment for chronic pain disorders. While there is evidence supporting improvement in pain intensity with SCS therapy, efforts to synthesize the evidence on physical functioning are lacking. OBJECTIVE: The primary objective of this meta-analysis was to assess long-term physical function following 12 months of SCS for chronic back pain. EVIDENCE REVIEW: PubMed, EMBASE, Scopus, and CENTRAL databases were searched for original peer-reviewed publications investigating physical function following SCS. The primary outcome was physical function at 12 months following SCS therapy for chronic back pain compared with baseline. A random effects model with an inverse variable method was used. The Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to determine the certainty of evidence. FINDINGS: A total of 518 studies were screened, of which 36 were included. Twenty-two studies were pooled in the meta-analysis. There was a significant reduction in Oswestry Disability Index (ODI) scores at all time frames up to 24 months following implantation. Pooled results revealed significant improvement in ODI scores at 12 months with a mean difference of -17.00% (95% CI -23.07 to -10.94, p<0.001). There was a very low certainty of evidence in this finding as per the GRADE framework. There was no significant difference in subgroup analyses based on study design (randomised controlled trials (RCTs) vs non-RCTs), study funding, or stimulation type. CONCLUSION: This meta-analysis highlights significant improvements in physical function after SCS therapy. However, this finding was limited by a very low GRADE certainty of evidence and high heterogeneity.

Effects of Slow Deep Breathing on Acute Clinical Pain in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Slow deep breathing (SDB) may help patients with acute pain. The primary aim of this systematic review and meta-analysis is to investigate the effects of SDB on acute pain. Secondary aims include investigating the effects of SDB on acute pain-related physical and emotional functioning. An a priori protocol was registered and a database search was conducted by a reference librarian. Randomized controlled trials (RCT) were eligible for inclusion and exclusion criteria included studies of SDB for non-pain indications and studies that applied SDB as a component of an encompassing intervention. The risk or bias was assessed using the Cochrane Collaboration's revised tool for assessing risk of bias in randomized trials. Meta-analysis was conducted using the random effects model. A total of 11 968 studies were screened and seven RCTs met inclusion criteria; five were judged to have low risk of bias. Meta-analysis of post-intervention pain scores demonstrated that SDB was associated with significantly lower pain scores compared with a control group, but with high levels of heterogeneity. Subgroup analyzes demonstrated that trials of burn pain were associated with a larger reduction in pain which partially explains the heterogeneity. Very low certainty evidence suggests that SDB may reduce acute pain intensity. Further research is needed to identify patients who are candidates for SDB and determine the best approach to deliver this therapy.