Dataset Information

Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review.

ABSTRACT:

Background

A randomized controlled trial (RCT) remains the pinnacle of clinical research design. However, RCTs in neurosurgery, especially those comparing surgery to non-operative treatment, are rare and their relevance and applicability have been questioned. This study set out to assess trial design and quality and identify their influence on outcomes in recent neurosurgical trials that compare surgery to non-operative treatment.

Methods

From 2000 to 2017, PubMed and Embase databases and four trial registries were searched. RCTs were evaluated for study design, funding, adjustments to reported outcome measures, accrual of patients, and academic impact.

Results

Eighty-two neurosurgical RCTs were identified, 40 in spine disorders, 19 neurovascular and neurotrauma, 11 functional neurosurgery, ten peripheral nerve, and two pituitary surgery. Eighty-four RCTs were registered, of which some are ongoing. Trial registration rate differed per subspecialty. Funding was mostly from non-industry institutions (58.5%), but 25.6% of RCTs did not report funding sources. 36.4% of RCTs did not report a difference between surgical and non-operative treatment, 3.7% favored non-operative management. Primary and secondary outcome measures were changed in 13.2% and 34.2% of RCTs respectively and varied by subspecialty. 41.9% of RCTs subtracted ??10% of the anticipated accrual and 12.9% of RCTs added ??10%. 7.3% of registered RCTs were terminated, mostly due to too slow recruitment. Subspecialty, registration, funding, masking, population size, and changing outcome measures were not significantly associated with a reported benefit of surgery. High Jadad scores (??4) were negatively associated with a demonstration of surgical benefit (P?ConclusionsNeurosurgical RCTs comparing surgical to non-operative treatment often find a benefit for surgical treatment. Changes to outcome measurements and anticipated accrual are common and funding sources are not always reported.

SUBMITTER: Martin E

PROVIDER: S-EPMC6431301 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review.

Martin Enrico E Muskens Ivo S IS Senders Joeky T JT DiRisio Aislyn C AC Karhade Aditya V AV Zaidi Hasan A HA Moojen Wouter A WA Peul Wilco C WC Smith Timothy R TR Broekman Marike L D MLD

Acta neurochirurgica 20190223 4

<h4>Background</h4>A randomized controlled trial (RCT) remains the pinnacle of clinical research design. However, RCTs in neurosurgery, especially those comparing surgery to non-operative treatment, are rare and their relevance and applicability have been questioned. This study set out to assess trial design and quality and identify their influence on outcomes in recent neurosurgical trials that compare surgery to non-operative treatment.<h4>Methods</h4>From 2000 to 2017, PubMed and Embase datab ...[more]

PMID: 30798479

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Project description:BackgroundThe primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials.MethodsPilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT).ResultsThe initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question.ConclusionsBased on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Project description:BackgroundThe effects of perioperative statin therapy on clinical outcome after cardiac or non-cardiac surgery are controversial. We aimed to assess the association between perioperative statin therapy and postoperative outcome.MethodsElectronic databases were searched up to May 1, 2018, for randomized controlled trials of perioperative statin therapy versus placebo or no treatment in adult cardiac or non-cardiac surgery. Postoperative outcomes were: myocardial infarction, stroke, acute kidney injury (AKI), and mortality. We calculated risk ratio (RR) or odds ratio (OR) and 95% confidence interval (CI) using fixed-effects meta-analyses. We performed meta-regression and subgroup analyses to assess the possible influence of statin therapy regimen on clinical outcomes and trial sequential analysis to evaluate the risk of random errors and futility.ResultsWe included data from 35 RCTs involving 8200 patients. Perioperative statin therapy was associated with lower incidence of postoperative myocardial infarction in non-cardiac surgery (OR = 0.44 [95% CI 0.30-0.64], p < 0.0001), but not in cardiac surgery (OR = 0.93 [95% CI 0.70-1.24], p = 0.61) (psubgroup = 0.002). Higher incidence of AKI was present in cardiac surgery patients receiving perioperative statins (RR = 1.15 [95% CI 1.00-1.31], p = 0.05), nonetheless not in non-cardiac surgery (RR = 1.52 [95% CI 0.71-3.26], p = 0.28) (psubgroup = 0.47). No difference in postoperative stroke and mortality was present in either cardiac or non-cardiac surgery. However, low risk of bias trials performed in cardiac surgery showed a higher mortality with statins versus placebo (OR = 3.71 [95% CI 1.03-13.34], p = 0.04). Subgroup and meta-regression analyses failed to find possible relationships between length of statin regimens and clinical outcomes. Trial sequential analysis suggested no firm conclusions on the topic.ConclusionsPerioperative statins appear to be protective against postoperative myocardial infarction in non-cardiac surgery and associated with higher AKI in cardiac surgery. Possible positive or even negative effects on mortality could not be excluded and merits further investigations. Currently, no randomized evidence supports the systematic administration of statins in surgical patients.

Dataset Information

Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review.

Background

Methods

Results

Publications

Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review.

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