Prospektive, untersucherinitiierte Studie mit einem dreidimensionalen, komplett autologen Chondrocytentransplantat zur Behandlung vollschichtiger Knorpeldefekte am Kniegelenk

Chipperfield's Circus at Bristol, Durdham Downs photographed 1956. Camels in enclosure with vehicle in the background

Variation in menopausal vasomotor symptoms outcomes in clinical trials: A systematic review

Background There is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis. Objectives To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments. Search strategy We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018. Selection criteria Randomised controlled trials with a primary outcome of menopausal vasomotor symptoms in women and a sample size of at least 20 women per study arm. Data collection and analysis Data about study characteristics, primary vasomotor-related outcomes and methods of measuring them. Main results The search identified 5591 studies, 214 of which were included. Forty-nine different primary reported outcomes were identified for vasomotor symptoms and 16 different tools had been used to measure these outcomes. The most commonly reported outcomes were frequency (97/214), severity (116/214), and intensity (28/114) of vasomotor symptoms or a composite of these outcomes (68/214). There was little consistency in how the frequency and severity/intensity of vasomotor symptoms were defined. Conclusions There is substantial variation in how menopausal vasomotor symptoms have been reported and measured in treatment trials. Future studies should include standardised outcome measures which reflect the priorities of patients, clinicians, and researchers. This is most effectively achieved through the development of a Core Outcome Set. This systematic review is the first step towards development of a Core Outcome Set for menopausal vasomotor symptoms. Tweetable summary Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required

CARE 2013 explanations and elaborations: Reporting guidelines for case reports

Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and feedback on clinical practice guidelines (CPGs), and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011-2012 a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.carestatement. org] and the EQUATOR Network, [www.equator-network.org] are resources for improving the completeness and transparency of case reports.</p