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The quality of surgical versus non-surgical randomized controlled trials.

ABSTRACT: Randomized controlled trials (RCTs) of surgical interventions are often more difficult to conduct, and their quality may lag behind other trials.To compare quality domains in trials of surgical interventions, to a previously reported control sample of general medical trials from December 2006.MEDLINE, EMBASE and CENTRAL were searched in May 2009.English language, full text RCTs, performed on humans that compared a surgical intervention to any other intervention.Records were ordered according to their date of publication. The most recently published trials were assessed first, until the required sample of 400 trials was obtained. The search and data collection were piloted by three authors, and was thereafter collected by one author. Data was checked.Although most quality domains were poorly reported, surgical trials compared favourably to general medical trials. Surgical trials were 24% more likely to have an adequate method of random sequence generation, and 71% more likely to have an adequate method of allocation concealment. However, blinding was 40% less likely to be adequate in surgical trials, and sources of funding were 33% less likely to be reported.A single author collected most data. Data was checked and this resulted in few changes.Reporting of most quality domains in surgical intervention trials was better than general medical trials. Blinding was less likely due to the difficulty in conducting sham surgical trials, and reporting of sources of support should improve with adherence to reporting guidelines.

SUBMITTER: Adie S

PROVIDER: S-EPMC5936696 | biostudies-other | 2017 Mar

REPOSITORIES: biostudies-other

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The quality of surgical versus non-surgical randomized controlled trials.

Adie Sam S Harris Ian A IA Naylor Justine M JM Mittal Rajat R

Contemporary clinical trials communications 20161210

<h4>Background</h4>Randomized controlled trials (RCTs) of surgical interventions are often more difficult to conduct, and their quality may lag behind other trials.<h4>Objectives</h4>To compare quality domains in trials of surgical interventions, to a previously reported control sample of general medical trials from December 2006.<h4>Data sources</h4>MEDLINE, EMBASE and CENTRAL were searched in May 2009.<h4>Study eligibility</h4>English language, full text RCTs, performed on humans that compared ...[more]

PMID: 29740621

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Project description:ObjectiveTo investigate the effectiveness and safety of surgery compared with non-surgical treatment for sciatica.DesignSystematic review and meta-analysis.Data sourcesMedline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the World Health Organisation International Clinical Trials Registry Platform from database inception to June 2022.Eligibility criteria for selecting studiesRandomised controlled trials comparing any surgical treatment with non-surgical treatment, epidural steroid injections, or placebo or sham surgery, in people with sciatica of any duration due to lumbar disc herniation (diagnosed by radiological imaging).Data extraction and synthesisTwo independent reviewers extracted data. Leg pain and disability were the primary outcomes. Adverse events, back pain, quality of life, and satisfaction with treatment were the secondary outcomes. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst pain or disability). Data were pooled using a random effects model. Risk of bias was assessed with the Cochrane Collaboration's tool and certainty of evidence with the grading of recommendations assessment, development, and evaluation (GRADE) framework. Follow-up times were into immediate term (≤six weeks), short term (>six weeks and ≤three months), medium term (>three and <12 months), and long term (at 12 months).Results24 trials were included, half of these investigated the effectiveness of discectomy compared with non-surgical treatment or epidural steroid injections (1711 participants). Very low to low certainty evidence showed that discectomy, compared with non-surgical treatment, reduced leg pain: the effect size was moderate at immediate term (mean difference -12.1 (95% confidence interval -23.6 to -0.5)) and short term (-11.7 (-18.6 to -4.7)), and small at medium term (-6.5 (-11.0 to -2.1)). Negligible effects were noted at long term (-2.3 (-4.5 to -0.2)). For disability, small, negligible, or no effects were found. A similar effect on leg pain was found when comparing discectomy with epidural steroid injections. For disability, a moderate effect was found at short term, but no effect was observed at medium and long term. The risk of any adverse events was similar between discectomy and non-surgical treatment (risk ratio 1.34 (95% confidence interval 0.91 to 1.98)).ConclusionVery low to low certainty evidence suggests that discectomy was superior to non-surgical treatment or epidural steroid injections in reducing leg pain and disability in people with sciatica with a surgical indication, but the benefits declined over time. Discectomy might be an option for people with sciatica who feel that the rapid relief offered by discectomy outweighs the risks and costs associated with surgery.Systematic review registrationPROSPERO CRD42021269997.

Project description:ObjectiveTo compare outcomes of endoscopic and surgical treatment for infected necrotizing pancreatitis (INP) based on results of randomized controlled trials (RCT).BackgroundTreatment of INP has changed in the last two decades with adoption of interventional, endoscopic and minimally invasive surgical procedures for drainage and necrosectomy. However, this relies mostly on observational studies.MethodsWe performed a systematic review following Cochrane and PRISMA guidelines and AMSTAR-2 criteria and searched CENTRAL, Medline and Web of Science. Randomized controlled trails that compared an endoscopic treatment to a surgical treatment for patients with infected walled-off necrosis and included one of the main outcomes were eligible for inclusion. The main outcomes were mortality and new onset multiple organ failure. Prospero registration ID: CRD42019126033 RESULTS: Three RCTs with 190 patients were included. Intention to treat analysis showed no difference in mortality. However, patients in the endoscopic group had statistically significant lower odds of experiencing new onset multiple organ failure (odds ratio (OR) confidence interval [CI] 0.31 [0.10, 0.98]) and were statistically less likely to suffer from perforations of visceral organs or enterocutaneous fistulae (OR [CI] 0.31 [0.10, 0.93]), and pancreatic fistulae (OR [CI] 0.09 [0.03, 0.28]). Patients with endoscopic treatment had a statistically significant lower mean hospital stay (Mean difference [CI] - 7.86 days [- 14.49, - 1.22]). No differences in bleeding requiring intervention, incisional hernia, exocrine or endocrine insufficiency or ICU stay were apparent. Overall certainty of evidence was moderate.ConclusionThere seem to be possible benefits of endoscopic treatment procedure. Given the heterogenous procedures in the surgical group as well as the low amount of randomized evidence, further studies are needed to evaluate the combination of different approaches and appropriate timepoints for interventions.

Project description:ObjectiveTo quantify the overall effects of bariatric surgery compared with non-surgical treatment for obesity.DesignSystematic review and meta-analysis based on a random effects model.Data sourcesSearches of Medline, Embase, and the Cochrane Library from their inception to December 2012 regardless of language or publication status.Eligibility criteriaEligible studies were randomised controlled trials with ≥ 6 months of follow-up that included individuals with a body mass index ≥ 30, compared current bariatric surgery techniques with non-surgical treatment, and reported on body weight, cardiovascular risk factors, quality of life, or adverse events.ResultsThe meta-analysis included 11 studies with 796 individuals (range of mean body mass index at baseline 30-52). Individuals allocated to bariatric surgery lost more body weight (mean difference -26 kg (95% confidence interval -31 to -21)) compared with non-surgical treatment, had a higher remission rate of type 2 diabetes (relative risk 22.1 (3.2 to 154.3) in a complete case analysis; 5.3 (1.8 to 15.8) in a conservative analysis assuming diabetes remission in all non-surgically treated individuals with missing data) and metabolic syndrome (relative risk 2.4 (1.6 to 3.6) in complete case analysis; 1.5 (0.9 to 2.3) in conservative analysis), greater improvements in quality of life and reductions in medicine use (no pooled data). Plasma triglyceride concentrations decreased more (mean difference -0.7 mmol/L (-1.0 to -0.4) and high density lipoprotein cholesterol concentrations increased more (mean difference 0.21 mmol/L (0.1 to 0.3)). Changes in blood pressure and total or low density lipoprotein cholesterol concentrations were not significantly different. There were no cardiovascular events or deaths reported after bariatric surgery. The most common adverse events after bariatric surgery were iron deficiency anaemia (15% of individuals undergoing malabsorptive bariatric surgery) and reoperations (8%).ConclusionsCompared with non-surgical treatment of obesity, bariatric surgery leads to greater body weight loss and higher remission rates of type 2 diabetes and metabolic syndrome. However, results are limited to two years of follow-up and based on a small number of studies and individuals.Systematic review registrationPROSPERO CRD42012003317 (www.crd.york.ac.uk/PROSPERO).

Project description:BACKGROUND:Carpal tunnel syndrome is a common compressive neuropathy of the median nerve. The efficacy and safety of endoscopic versus open carpal tunnel release remain controversial. QUESTIONS/PURPOSES:The purpose of this study was to determine whether endoscopic compared with open carpal tunnel release provides better symptom relief, validated outcome scores, short- and long-term strength, and/or digital sensibility; entails a differential risk of complications such as nerve injury, scar tenderness, pillar pain, and reoperation; allows an earlier return to work; and takes less operative time. METHODS:The English-language literature was searched using MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials. Randomized controlled trials that compared endoscopic and open carpal tunnel release were included in the meta-analysis. Methodologic quality was assessed with the Consolidated Standards Of Reporting Trials (CONSORT) checklist, and a sensitivity analysis was performed. Symptom relief, Boston Carpal Tunnel Questionnaire (BCTQ) scores, strength, digital sensibility, complications, reoperation, interval to return to work, and operative time were analyzed. Twenty-one randomized controlled trials containing 1859 hands were included. RESULTS:Endoscopically treated patients showed similar symptom relief and BCTQ scores; better early recovery of grip strength (mean difference [MD], 3.03 kg [0.08-5.98]; p = 0.04) and pinch strength (MD, 0.77 kg [0.33-1.22]; p < 0.001) but no advantage after 6 months; lower risk of scar tenderness (risk ratio [RR], 0.53 [0.35-0.82]; p = 0.005); higher risk of nerve injury (RR, 2.84 [1.08-7.46]; p = 0.03), most of which were transient neurapraxias. Similar risk of pillar pain and reoperation; an earlier return to work (MD, -8.73 days [-12.82 to -4.65]; p < 0.001); and reduced operative time (MD, -4.81 minutes [-9.23 to -0.39]; p = 0.03). CONCLUSIONS:High-level evidence from randomized controlled trials indicates that endoscopic release allows earlier return to work and improved strength during the early postoperative period. Results at 6 months or later are similar according to current data except that patients undergoing endoscopic release are at greater risk of nerve injury and lower risk of scar tenderness compared with open release. While endoscopic release may appeal to patients who require an early return to work and activities, surgeons should be cognizant of its elevated incidence of transient nerve injury amid its similar overall efficacy to open carpal tunnel release. Additional research is required to define the learning curve of endoscopic release and clarify the influence of surgeon volume on its safety.

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The quality of surgical versus non-surgical randomized controlled trials.

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The quality of surgical versus non-surgical randomized controlled trials.

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