Suchergebnisse

Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial's impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs. Conclusion An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

Background Nutrition and physical activity policies have the potential to influence lifestyle patterns and reduce the burden of non-communicable diseases. In the world of health-related guidelines, GRADE (Grading of Recommendations, Assessment, Development and Evaluation) is the most widely used approach for assessing the certainty of evidence and determining the strength of recommendations. Thus, it is relevant to explore its usefulness also in the process of nutrition and physical activity policymaking and evaluation. The purpose of this scoping review was (i) to generate an exemplary overview of documents using the GRADE approach in the process of nutrition and physical activity policymaking and evaluation, (ii) to find out how the GRADE approach has been applied, and (iii) to explore which facilitators of and barriers to the use of GRADE have been described on the basis of the identified documents. The overarching aim of this work is to work towards improving the process of evidence-informed policymaking in the areas of dietary behavior, physical activity, and sedentary behavior. Methods A scoping review was conducted according to current reporting standards. MEDLINE via Ovid, the Cochrane Library, and Web of Science were systematically searched up until 4 July 2019. Documents describing a body of evidence which was assessed for the development or evaluation of a policy, including documents labeled as "guidelines," or systematic reviews used to inform policymaking were included. Results Thirty-six documents were included. Overall, 313 GRADE certainty of evidence ratings were identified in systematic reviews and guidelines; the strength of recommendations/policies was assessed in four documents, and six documents mentioned facilitators or barriers for the use of GRADE. The major reported barrier was the initial low starting level of a body of evidence from non-randomized studies when assessing the certainty of evidence. Conclusion This scoping review found that the GRADE approach has been used for policy evaluations, in the evaluation of the effectiveness of policy-relevant interventions (policymaking), as well as in the development of guidelines intended to guide policymaking. Several areas for future research were identified to explore the use of GRADE in health policymaking and evaluation.