Neurosurgical Randomized Controlled Trials—Distance Travelled

Azad, Tej D.; Veeravagu, Anand; Mittal, Vaishali; Esparza, Rogelio; Johnson, Eli; Ioannidis, John P. A.; Grant, Gerald A.

doi:10.1093/neuros/nyx319

Cited by 23 publications

(23 citation statements)

References 26 publications

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“…In an effort to remain consistent with the previous work of Vranos et al 7 and Azad et al 8 to characterize and assess the state of neurosurgical RCTs, we utilized the database of RCTs described by Azad et al 8 for our data extraction. The search strategy and review protocol are outlined in the supplementary data of their report.…”

Section: Methodsmentioning

confidence: 99%

“…The search strategy and review protocol are outlined in the supplementary data of their report. In brief, Azad et al 8 searched MEDLINE, Scopus, and the Cochrane Library Controlled Trials Registry from January 2003 to July 2016 aiming to identify randomized trials of neurosurgical procedures used in “cranial and spinal neurosurgical practice, excluding trials of peripheral nerve procedures.” 8 All randomized trials compared one neurosurgical procedure with another neurosurgical procedure, nonsurgical treatment, or no treatment. Studies with <5 patients in each arm and studies that compared drugs, physical therapy, or conventional radiotherapy alone were excluded.…”

Section: Methodsmentioning

confidence: 99%

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Neurosurgical Randomized Trials in Low- and Middle-Income Countries

et al. 2020

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BACKGROUND The setting of a randomized trial can determine whether its findings are generalizable and can therefore apply to different settings. The contribution of low- and middle-income countries (LMICs) to neurosurgical randomized trials has not been systematically described before. OBJECTIVE To perform a systematic analysis of design characteristics and methodology, funding source, and interventions studied between trials led by and/or conducted in high-income countries (HICs) vs LMICs. METHODS From January 2003 to July 2016, English-language trials with >5 patients assessing any one neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. Income classification for each country was assessed using the World Bank Atlas method. RESULTS A total of 73.3% of the 397 studies that met inclusion criteria were led by HICs, whereas 26.7% were led by LMICs. Of the 106 LMIC-led studies, 71 were led by China. If China is excluded, only 8.8% were led by LMICs. HIC-led trials enrolled a median of 92 patients vs a median of 65 patients in LMIC-led trials. HIC-led trials enrolled from 7.6 sites vs 1.8 sites in LMIC-led studies. Over half of LMIC-led trials were institutionally funded (54.7%). The majority of both HIC- and LMIC-led trials evaluated spinal neurosurgery, 68% and 71.7%, respectively. CONCLUSION We have established that there is a substantial disparity between HICs and LMICs in the number of published neurosurgical trials. A concerted effort to invest in research capacity building in LMICs is an essential step towards ensuring context- and resource-specific high-quality evidence is generated.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Neurosurgical Randomized Trials in Low- and Middle-Income Countries

et al. 2020

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“…However, the true aim of the framework is to facilitate the conduct of well-designed and well-executed studies in order to facilitate the adoption of innovative techniques, if found to be effective. A recent example is the use of middle meningeal artery (MMA) embolization for chronic subdural hematomas (CSDH), where the majority of conducted studies are case series [ 6 ]. Although this procedure is clearly innovative, many of the studies reported use of MMA embolization for atypical indications (e.g., asymptomatic patients, as “prophylaxis” after surgery) outside the context of ethically approved research.…”

Section: Discussionmentioning

confidence: 99%

“…Some authors suggest that routinely collected or observational data can lead to robust conclusions regarding the comparative effectiveness of treatment; however, this is a relatively new field with ongoing methodological challenges. As an example, a recent study found that observational studies based on routinely collected health data could give different answers from subsequent randomized trials on the same clinical questions and may substantially overestimate treatment effects [ 6 ]. Reasons for this are likely multiple, and while this difference could reflect a difference in validity achieved by the different study methodologies, it is important to consider the impact the highly selective populations used for randomized trials could have on research outcomes, in comparison with the broader populations that usually contribute to observational studies.…”

Section: Discussionmentioning

confidence: 99%

The IDEAL framework in neurosurgery: a bibliometric analysis

et al. 2020

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Background The Idea, Development, Exploration, Assessment and Long-term study (IDEAL) framework was created to provide a structured way for assessing and evaluating novel surgical techniques and devices. Objectives The aim of this paper was to investigate the utilization of the IDEAL framework within neurosurgery, and to identify factors influencing implementation. Methods A bibliometric analysis of the 7 key IDEAL papers on Scopus, PubMed, Embase, Web of Science, and Google Scholar databases (2009–2019) was performed. A second journal-specific search then identified additional papers citing the IDEAL framework. Publications identified were screened by two independent reviewers to select neurosurgery-specific articles. Results The citation search identified 1336 articles. The journal search identified another 16 articles. Following deduplication and review, 51 relevant articles remained; 14 primary papers (27%) and 37 secondary papers (73%). Of the primary papers, 5 (36%) papers applied the IDEAL framework to their research correctly; two were aligned to the pre-IDEAL stage, one to the Idea and Development stages, and two to the Exploration stage. Of the secondary papers, 21 (57%) explicitly discussed the IDEAL framework. Eighteen (86%) of these were supportive of implementing the framework, while one was not, and two were neutral. Conclusion The adoption of the IDEAL framework in neurosurgery has been slow, particularly for early-stage neurosurgical techniques and inventions. However, the largely positive reviews in secondary literature suggest potential for increased use that may be achieved with education and publicity.

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“…Therefore, we decline any sort of direct involvement and study-related financial support by the industry, and aim to minimise personal conflict of interests with device manufacturers. This may enable execution and critical appraisal of the study results with less bias 55 56…”

Section: Discussionmentioning

confidence: 99%

The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion

et al. 2019

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IntroductionRobotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the last decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared with conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high inherent costs. As a non-randomised, expertise-based study, the European Robotic Spinal Instrumentation Study aims to create prospective multicentre evidence on the potential comparative clinical benefits of RG, NV and FH in a real-world setting.Methods and analysisPatients are allocated in a non-randomised, non-blinded fashion to the RG, NV or FH arms. Adult patients that are to undergo thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumours or fractures are considered for inclusion. Deformity correction and surgery at more than five levels represent exclusion criteria. Follow-up takes place at 6 weeks, as well as 12 and 24 months. The primary endpoint is defined as the time to revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year. Secondary endpoints include patient-reported back and leg pain, as well as Oswestry Disability Index and EuroQOL 5-dimension questionnaires. Use of analgesic medication and work status are recorded. The primary analysis, conducted on the 12-month data, is carried out according to the intention-to-treat principle. The primary endpoint is analysed using crude and adjusted Cox proportional hazards models. Patient-reported outcomes are analysed using baseline-adjusted linear mixed models. The study is monitored according to a prespecified monitoring plan.Ethics and disseminationThe study protocol is approved by the appropriate national and local authorities. Written informed consent is obtained from all participants. The final results will be published in an international peer-reviewed journal.Trial registration numberClinical Trials.gov registryNCT03398915; Pre-results, recruiting stage.

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Neurosurgical Randomized Controlled Trials—Distance Travelled

Abstract: 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.

Cited by 23 publications

References 26 publications

Neurosurgical Randomized Trials in Low- and Middle-Income Countries

Neurosurgical Randomized Trials in Low- and Middle-Income Countries

The IDEAL framework in neurosurgery: a bibliometric analysis

The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion

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