Introduction: Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Moreover, meta-analyses are the staple to test for drug efficacy and adverse effects, but spins can lead to unconvincing conclusions. In a shared medical decision-making approach, general practitioners need drug assessment to be based on patient-important outcomes. The aim of project Rebuild the Evidence Base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. Methods and Analysis: The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome : 1) a meta-analysis, based on randomised controlled trials (RCTs) with low risk of bias overall ; 2) Confirmatory RCT with low risk of biais overall; 3) Heterogeneity between RCT, and 4) Publication bias assessment. Depending on the results of these analyses, evidence would be rated according to 4 levels: firm evidence, evidence, results to be confirmed (but no evidence) or lack of evidence. Conclusion: Project REB proposes a method for reading and interpreting randomized clinical trials and their meta-analysis to produce quality data for general practitioners to focus on benefit-risk assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.

Objective: To demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labour and delivery (TID) as compared to a vaginal dinoprostone insert in cases of PROM at term. Design: Prospective, randomized, controlled trial. Setting: French university hospital Population: Patients undergoing labour induction for PROM at term with unfavorable cervix. Methods: We compared the double balloon catheter over a period of 12 hours with adjunction of oxytocin 6 hours after catheter insertion, versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. Main outcome measures: The primary outcome was TID. Secondary outcomes concerned delivery mode, maternal and fetal outcome and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 vs 20.2 hours, ES = 0.16 (-0.27 to 0.60), p=0.12) in catheter group versus dinoprostone except in nulliparous women (17.0 vs 26.5 hours, ES = 0.62 (0.10 to 1.14), p=0.006). The rate of vaginal delivery <24h significantly increased with combined induction (88.5% vs 66.6%, p=0.03). No statistical difference was observed concerning caesarean rate (12.5% vs 17.5%, p>0.05), chorioamnionitis (0% vs 2.5%, p=1), postpartum endometritis, maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Conclusion: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.