Neurosurgical Randomized Controlled Trials—Distance Travelled
| العنوان: | Neurosurgical Randomized Controlled Trials—Distance Travelled |
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| المؤلفون: | Anand Veeravagu, Tej D. Azad, Eli Johnson, John P. A. Ioannidis, Rogelio Esparza, Gerald A. Grant, Vaishali Mittal |
| المصدر: | Neurosurgery. 82:604-612 |
| بيانات النشر: | Ovid Technologies (Wolters Kluwer Health), 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | medicine.medical_specialty, Randomization, business.industry, MEDLINE, Middle Aged, Cochrane Library, Neurosurgical Procedures, Neurosurgical Procedure, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Sample size determination, medicine, Physical therapy, Humans, Surgery, 030212 general & internal medicine, Neurology (clinical), Neurosurgery, Quality characteristics, business, 030217 neurology & neurosurgery, Randomized Controlled Trials as Topic |
| الوصف: | BACKGROUND The evidence base for many neurosurgical procedures has been limited. We performed a comprehensive and systematic analysis of study design, quality of reporting, and trial results of neurosurgical randomized controlled trials (RCTs). OBJECTIVE To systematically assess the design and quality characteristics of neurosurgical RCTs. METHODS From January 1961 to June 2016, RCTs with >5 patients assessing any 1 neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. RESULTS The median sample size in the 401 eligible RCTs was 73 patients with a mean patient age of 49.6. Only 111 trials (27.1%) described allocation concealment, 140 (34.6%) provided power calculations, and 117 (28.9%) were adequately powered. Significant efficacy or trend for efficacy was claimed in 226 reports (56.4%), no difference between the procedures was found in 166 trials (41.4%), and significant harm was reported in 9 trials (2.2%). Trials with a larger sample size were more likely to report randomization mode, specify allocation concealment, and power calculations (all P < .001). Government funding was associated with better specification of power calculations (P = .008) and of allocation concealment (P = .026), while industry funding was associated with reporting significant efficacy (P = .02). Reporting of funding, specification of randomization mode and primary outcomes, and mention of power calculations improved significantly (all, P < .05) over time. CONCLUSION Several aspects of the design and reporting of RCTs on neurosurgical procedures have improved over time. Better powered and accurately reported trials are needed in neurosurgery to deliver evidence-based care and achieve optimal outcomes. |
| تدمد: | 1524-4040 0148-396X |
| DOI: | 10.1093/neuros/nyx319 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b6926e78fb163a3f3d99782b4d41ec66 https://doi.org/10.1093/neuros/nyx319 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....b6926e78fb163a3f3d99782b4d41ec66 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15244040 0148396X |
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| DOI: | 10.1093/neuros/nyx319 |