BMJ open
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Observational Study
Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.
Novel therapeutics are an important part of ophthalmologists' armamentarium, and the risks and benefits of these therapies must be carefully evaluated. We sought to quantify the characteristics of the pivotal clinical trials supporting the regulatory approval of new ophthalmic drugs and medical devices. ⋯ Ophthalmic therapeutics were approved based on varying levels of evidence. Postapproval studies could be used to confirm or refute early indications of safety and effectiveness of these therapeutics, with the study results accessible to patients and clinicians who need to make informed treatment decisions.
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Evidence-based medicine promotes and relies on the use of evidence in developing clinical practice guidelines (CPGs). The Chinese healthcare system includes both traditional Chinese medicine (TCM) and Western medicine, which are expected to be equally reflected in Chinese CPGs. ⋯ Few Chinese Western medicine CPGs recommend TCM therapies and very few provide evidence grading for the TCM recommendation. We suggest that future guideline development should be based on systematic searches for evidence to support CPG recommendations and involve a multidisciplinary approach including TCM expertise.
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To conduct a secondary analysis of data from the UK Obstetric Surveillance System (UKOSS) to estimate the rates of specific maternal risks associated with planned vaginal birth after caesarean (VBAC) and elective repeat caesarean section (ERCS). ⋯ While the risk of uterine rupture in the VBAC and ERCS groups is well understood, this national study did not demonstrate any other clear differences in the outcomes we examined. The absolute and relative risks of maternal complications were small in both groups. Large epidemiological studies could further help to assess whether the incidence of these rare outcomes would significantly differ between the VBAC and ERCS groups if a larger number of cases were to be examined. In the interim, this study provides important information to help pregnant women in their decision-making process.
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To investigate agreement and potential differences in the application and interpretation of the definition among surgical departments of various hospitals. ⋯ The definition of surgical complications as currently applied in the Netherlands does not ensure a uniform complication registration. Improvement of this registration system is mandatory before benchmarking of these findings in the public domain is appropriate. Modifications of the current definition of a surgical complication, and improved consensus about specific clinical situations and training of surgeons might improve the quality of benchmarking.