BackgroundThere is an international trend to shorten the postpartum length of stay in hospitals, driven by cost containment, hospital bed availability and a movement toward the ‘demedicalization’ of birth. The aim of this systematic literature review is to determine how early postnatal discharge policies from hospitals could affect health outcomes after vaginal delivery for healthy mothers and term newborns.MethodsA search for systematic reviews, meta-analyses, and primary studies was carried out in OVID MEDLINE, Embase, CINAHL, Econlit and the Cochrane Library (Cochrane Database of Systematic Reviews, DARE and HTA databases). The AMSTAR checklist was used for the quality appraisal of systematic reviews. The quality of the retrieved studies was assessed by the Cochrane Collaboration’s tools. The level of evidence was appraised using the GRADE system.ResultsSeven RCTs and two additional observational studies were found but no comprehensive economic evaluation. Despite variation in the definition of early discharge, the authors of the included studies, concerning early discharge and conventional length of stay, reported no statistical difference in maternal and neonatal morbidity, maternal and neonatal readmission rates, infant mortality, newborn weight gain, neonatal hyperbilirubinemia, or breastfeeding rates. The authors reported conflicting results regarding postpartum depression and competence of mothering, ranging from no difference according to length of stay to better results for early discharge. The level of evidence of the vast majority of outcomes was rated as low to very low.ConclusionsBecause of the lack of robust clinical evidence and full economic evaluations, the current data neither support nor discourage the widespread use of early postpartum discharge. Before implementing an early discharge policy, Western countries with longer length of hospital stay may benefit from testing shorter length of stay in studies with an appropriate design. The issue of cost containment in implementing early discharge and the potential impact on the current and future health of the population exemplifies the need for publicly funded clinical trials in such public health area. Finally, trials testing the range of out-patient interventions supporting early discharge are needed in Western countries which implemented early discharge policies in the past.

The Ottawa ankle rules remain of utmost importance in identifying X-ray eligible patients with acute ankle sprains. The role of the Bernese ankle rules instead of the OAR and the added-value of the tuning fork test and ultrasound in patients with positive OAR are promising but should be confirmed. ABSTRACTBackground Ankle sprain is frequently encountered, both in primary care and in emergency departments. Since 1992, the Ottawa ankle rules (OAR) can assist clinicians in determining whether an X-ray should be performed to exclude a fracture. Several guidelines recommend the use of OAR based on a systematic review from 2003. Ten years later, one can wonder if this recommendation should be changed. Objective To review systematically the current evidence on the most accurate method to assess the fracture risk after an ankle sprain in adults. Methods A methodical search for systematic reviews, meta-analyses and primary studies was carried out in Medline, Cochrane Database of systematic reviews, Embase, Pedro, CINAHL, Medion and specific guideline search engines. At least two independent researchers performed selection, quality appraisal (with validated checklists) and data extraction. Results One systematic review and 21 primary studies were selected. Sensitivity and specificity of the OAR range from 92-100% and from 16-51%, respectively. To improve the OAR specificity, other tools are proposed such as the Bernese ankle rules. Vibrating tuning fork test and ultrasound could be useful in patient with OAR positive to decrease the need for radiographs. No evidence was found in favour of the use of magnetic resonance imaging (MRI) or computed tomography (CT) in the acute phase of ankle sprain. Conclusion The findings confirm the value of the OAR at ruling out fractures after an ankle sprain and propose other or additional tools to decrease the need for X-rays.

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ObjectivePersonalised medicine (PM) allows treating patients based on their individual demographic, genomic or biological characteristics for tailoring the ‘right treatment for the right person at the right time’. Robust methodology is required for PM clinical trials, to correctly identify groups of participants and treatments. As an initial step for the development of new recommendations on trial designs for PM, we aimed to present an overview of the study designs that have been used in this field.DesignScoping review.MethodsWe searched (April 2020) PubMed, Embase and the Cochrane Library for all reports in English, French, German, Italian and Spanish, describing study designs for clinical trials applied to PM. Study selection and data extraction were performed in duplicate resolving disagreements by consensus or by involving a third expert reviewer. We extracted information on the characteristics of trial designs and examples of current applications of these approaches. The extracted information was used to generate a new classification of trial designs for PM.ResultsWe identified 21 trial designs, 10 subtypes and 30 variations of trial designs applied to PM, which we classified into four core categories (namely, Master protocol, Randomise-all, Biomarker strategy and Enrichment). We found 131 clinical trials using these designs, of which the great majority were master protocols (86/131, 65.6%). Most of the trials were phase II studies (75/131, 57.2%) in the field of oncology (113/131, 86.3%). We identified 34 main features of trial designs regarding different aspects (eg, framework, control group, randomisation). The four core categories and 34 features were merged into a double-entry table to create a new classification of trial designs for PM.ConclusionsA variety of trial designs exists and is applied to PM. A new classification of trial designs is proposed to help readers to navigate the complex field of PM clinical trials.