[GRADE: Evidence to Decision (EtD) framework for coverage decisions]. / GRADE: Von der Evidenz zur Empfehlung oder Entscheidung ­ Entscheidungen zur Kostenerstattung.

BACKGROUND: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE project, a GRADE working group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) frameworks for different types of decisions, including coverage ones. METHODS: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. RESULTS: The general structure of the EtD includes formulation of the question, an assessment using 12 criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. CONCLUSION: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.

Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee.

OBJECTIVE: To assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe. DESIGN: Observational cross-sectional study. SETTING: A large German ethics committee. MATERIALS: From 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 MEASURES: Besides the design of the studies, we assessed the planned sample size, study duration and other aspects. RESULTS: 122 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. CONCLUSION: A large proportion of MD studies in Germany apply a randomised controlled design, thus contradicting the industry argument that RCTs on MDs are commonly infeasible.

Community gardening, community farming and other local community-based gardening interventions to prevent overweight and obesity in high-income and middle-income countries: protocol for a systematic review.

INTRODUCTION: The 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 ANALYSIS: We 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 DISSEMINATION: For 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 NUMBER: International Prospective Register of Systematic Reviews (PROSPERO)(CRD42017043696).