IntroductionThe worldwide prevalence of overweight/obesity has continued to rise over the last decades. To reverse this trend, public health authorities are exploring cost-effective interventions, especially in high-income and middle-income countries. Community gardening offers a unique opportunity for individuals to enhance physical activity levels and improve their diet. However, synthesised evidence on the short-term or long-term effectiveness and on the costs of community gardening interventions to prevent overweight/obesity remains limited. Therefore, this review will investigate: (1) the effectiveness of voluntary participation in community gardening compared with no or a control intervention on overweight/obesity and associated health outcomes, (2) effects on different subgroups of populations and (3) the costs of community gardening interventions.Methods and analysisWe will conduct a systematic review, limited to evaluations of community gardening interventions with controlled quantitative and interrupted time series designs. To identify relevant articles, we will systematically search 12 academic and 5 grey literature databases, as well as 2 trial registers and 6 websites. Articles will then be assessed for eligibility based on a predefined set of criteria. At least two independent reviewers will assess each article for relevance, before evaluating the methodological quality and potential bias of the studies. Data relevant to the objectives of this review will be extracted and cross-validated. Any disagreements will be mediated by a third reviewer. If feasible, meta-analyses of primary outcomes (overweight/obesity, physical activity, food intake, energy intake) will be conducted. We will use the Grading of Recommendations Assessment, Development and Evaluation method to assess the overall quality of evidence.Ethics and disseminationFor this review, no ethical approval is required as we will only extract and analyse secondary data. We aim to submit the final review manuscript to an open access journal for publication and disseminate results via conferences and social media.Trial registration numberInternational Prospective Register of Systematic Reviews (PROSPERO)(CRD42017043696).

ObjectiveTo assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe.DesignObservational cross-sectional study.SettingA large German ethics committee.MaterialsFrom the consecutive sample of study applications between March 2010 and December 2013, we selected MD study applications requiring approval by an ethics committee and the competent federal authority. These included pre-market studies on devices that had not yet received a CE (Conformité Européenne) mark or had previously been CE marked for a different indication. Also included were post-CE studies requiring federal authority approval because the study entailed additional invasive or otherwise burdensome components.Primary and secondary outcome measuresBesides the design of the studies, we assessed the planned sample size, study duration and other aspects.Results122 study applications were analysed: 98 (80%) concerned therapeutic rather than diagnostic devices and 84 (69%) were pre-market studies. The proportion of studies on class I, IIa, IIb and III devices was 10%, 15%, 28% and 39%, respectively. 10 studies (8%) investigated IVD MDs. A randomised controlled trial (RCT) was planned in 70 (57%) of the 122 applications; studies with non-randomised control groups (n=23; 19%) or without controls (n=29; 24%) were less common. In the sub-group of pre-market studies on therapeutic devices, the proportion of RCTs was 66% (43/65). The median sample size was 120 participants or samples (IQR 53–229). The median study duration was 24 (14–38) months. 87 studies (71%) considered at least one patient-relevant outcome. 12 (17%) and 37 (53%) of the 70 RCTs applied a fully or partially blinded design, respectively.ConclusionA large proportion of MD studies in Germany apply a randomised controlled design, thus contradicting the industry argument that RCTs on MDs are commonly infeasible.

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QALY. In univariate analysis, all variables showed significant association with ICER. However, in multivariate regression analysis, three variables; absence of alternative, disease severity and cancer, rare diseases significantly increased ICER(p< 0.05). The most influencing factor raising ICER was catastrophic disease, followed by disease severity, no alternative, and limited alternatives. The degree of impact were in 17, 14, 12, 8 millions KRW per QALY. ConClusions: This study confirmed that most of the factors were considered as modifiers of ICER on PBC's deliberation in positively recommended cases. The coefficient estimates of variables probably give an impression to any stakeholders seeking reasonable approximate ICER threshold for pharmaceuticals.