revamped and the PEGASUS (electronic submission) system will be updated to reflect the changes. There will be many helpful online links provided. We will ...
118KB Sizes 0 Downloads 145 Views
THE REGISTRAR support.7 Most importantly, neurosurgical RCTs are frequently followed by obvious, rapid shifts in community practice patterns, both toward effective therapies8-11 and away from ineffective ones.12-14

Why Are We Doing This? What Are They? In a word—QUALITY—there is substantial evidence that there are significant deficiencies in the medical literature regarding the reporting of research studies. These shortcomings include the omission of valuable information about research methods or interventions, selective reporting of outcomes or risk, and ambiguous or confusing data. These errors can lead to incorrect conclusions, some with deleterious results for patients, misdirection of practitioners and poor decisionmaking by policy makers. These observations have lead to the development and dissemination of guidelines and checklists to assist researchers, authors, reviewers, editors and journals to meet certain standards of best practice. They are designed by experts in study design, epidemiology, biostatistics, and research methodology. The routine use of these research reporting guidelines by biomedical journals has become an important step in quality control. Reporting guidelines complement the journals’ existing instructions to authors. Many journals require them. The published report of a study provides a clear explanation of the study methods and statistical techniques to allow independent verification of the results and much more. NEUROSURGERYÒ has taken a huge step in endorsing these guidelines and statements and will require them for submissions. A full report of this initiative follows below.

Neurosurgical RCTs Are Scarce and Not Always Well Reported Although highly influential, RCTs are relatively uncommon in the neurosurgical literature, comprising far fewer published studies than weaker designs such as case series and case reports.15 RCTs form a smaller fraction of papers published in neurosurgical journals than in internal medicine, general surgery, or many surgical subspecialties.16, 17 An extensive literature has been devoted to the particular difficulties of conducting RCTs on surgical questions,18-20 but the specific reasons for the paucity of RCTs in neurosurgery are still elusive.15 Perhaps the perception that neurosurgical diseases are rare, and that mistaken therapies can result in severe consequences, could be contributing factors – although pediatric oncologists in the US face similar problems while achieving far higher enrollment rates of eligible patients onto clinical trials.21 Some evidence, however, suggests that the number of RCTs on neurosurgical topics has been slowly increasing.15, 22 Given the combination of the scarcity of neurosurgical RCTs and their singular value in shaping clinical decisions, it is particularly unfortunate that many neurosurgical RCTs show flaws in design and reporting. Vranos et al surveyed 108 RCTs on neurosurgical procedures published between 1966 and 2002; they found that many trials were underpowered, and few reported power calculations or allocation concealment adequately.23 In a more recent survey of 159 neurosurgical RCTs, Scho¨ller et al found that almost half of trials had inadequate reporting of allocation concealment while only a third reported intent-to-treat analysis.24 These deficiencies in the quality of published neurosurgical RCTs are not unique or even unusual.25 Systematic reviews have found that similar flaws in conduct or reporting are endemic to RCTs reported in both medical and surgical journals, even those that are highlycited.26-29 However, evidence suggests that trials evaluating nonpharmacological therapies, such as surgical procedures, face special challenges in clear and accurate trial reporting.30-32 For example, in a systematic review on randomized and nonrandomized published studies of 4 orthopedic operations, reviewers found that nearly 30% of studies lacked details about how the operations had been performed that surgeons considered necessary to proper interpretation of the trials’ results.33