[GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health]. / GRADE-Leitlinien: 16. Von der Evidenz zur Empfehlung oder Entscheidung ­ Vorgehen nach GRADE für Tests in der klinischen Praxis und in Public Health.

OBJECTIVE: To describe the Grading of Recommendations Assessment, Development and Evaluation (GRADE) interactive Evidence to Decision (EtD) frameworks for tests and test strategies for clinical, public health or coverage decisions. STUDY DESIGN AND SETTING: As part of the GRADE Working Group's DECIDE project we conducted workshops, user testing with systematic review authors, guideline developers and other decision makers, and piloted versions of the EtD framework. RESULTS: EtD frameworks for tests share the structure, explicitness, and transparency of other EtD frameworks. They require specifying the purpose of the test, linked or related management and the key outcomes of concern for different test results and subsequent management. The EtD criteria address test accuracy and assessments of the certainty of the additional evidence necessary for decision-making. When there is no direct evidence of test effects on patient important outcomes, formal or informal modeling is needed to estimate effects. We describe the EtD criteria based on examples developed with GRADEpro (www.gradepro.org), GRADE's software that also provides interactive Summary of Findings Tables. CONCLUSION: EtD frameworks for developing recommendations and making decisions about tests lay out the sequential steps in reviewing and assessing the different types of evidence that need to be linked.

Patients' advocates and counselors: Perceived needs in education and training.

OBJECTIVE: Since there is a lack of knowledge on the occupational needs of patient representatives (PRs) and counselors (PCs), we performed a study eliciting perceived skills and informational needs in evidence-based medicine (EbM) and health economics (HE) and investigated preferences for training. METHODS: Semi-structured interviews and an online survey were conducted among PRs and PCs in Germany. Questions covered perceived skills and informational needs in EbM and HE and preferences for training in both fields. Interview data was analyzed using the grounded theory method. Survey results were analyzed by means of descriptive statistics. RESULTS: Nine personal interviews, one group discussion and 50 survey forms were analyzed. Respondents reported better skills in EbM compared to HE but felt a need for training in both fields. Important barriers mentioned were difficulties in reading scientific articles written in English and understanding statistics. Preferences for training included regionally widespread offers, availability of refresher classes, and a mixture of presence-based and online courses. CONCLUSION: PRs and PCs perceive a considerable need for formal training in EbM and HE and have clear expectations of the format and design. PRACTICE IMPLICATION: Trainings in EbM and HE could help to enhance patient and public involvement (PPI) in Germany.

A qualitative study on barriers to evidence-based practice in patient counseling and advocacy in Germany.

BACKGROUND: Despite the attempt to integrate evidence-based practice (EBP) in patient counseling and advocacy, there is limited knowledge on the status quo of this process in the German health care system. Our objective was to identify important determinants influencing the application of EBP in the counseling and advocacy setting in Germany. METHODS: We carried out a qualitative study performing semi-structured expert interviews and one group discussion among n = 9 patient counselors (PCs) and patient advocates (PAs) identified via expert recommendations and by contacting relevant institutions. The interview manual was developed on the basis of a literature review on barriers/facilitators of EBP in health care delivery and a preamble oriented pyramid discussion with a multidisciplinary team. Interviews were analyzed using the Grounded Theory method. A paradigm was developed to present the interrelations between hindering and facilitating factors for EBP and the attitude towards the utilization of EBP among PAs and PCs. RESULTS: Findings from nine face-to-face interviews and one group discussion demonstrate that by now PCs and PAs do not recognize EBP as a tool to facilitate the professionalization of patient counselors and advocates. This result is due to individual and institutional barriers such as cognitive-behavioral, professional, attitude related as well as resource and system barriers. PCs and PAs have predominantly critical attitudes towards EBP caused by a lack of trust in its reliability and by concerns regarding unfavorable effects EBP may have on the relationship with the patient and on the cooperation with physicians. A missing infrastructure of needs-based EBP training programs also discourages PCs and PAs from engaging in EBP. Despite the numerous hindering factors, there is also a growing awareness that EBP could help to improve patient counseling and advocacy. To facilitate EBP in future, needs-based training programs and health policy interventions that support interdisciplinary collaboration are required. CONCLUSION: Although EBP among PCs and PAs is gaining importance, it is still less likely to be recognized as helpful and its application faces various barriers. More needs-based EBP training programs and health policy interventions to decrease barriers and foster interdisciplinary collaboration are necessary.

Quality scores do not predict discrepant statistical significances among meta-analyses on different targets of glycemic control in type 2 diabetes.

OBJECTIVES: To examine differences in conclusions, statistical significances, and quality of systematic reviews on preventive effects of different targets of blood glucose lowering on macrovascular events in patients with type 2 diabetes. STUDY DESIGN AND SETTING: We searched MEDLINE, the Cochrane Database of Systematic Reviews, and Embase until October 15, 2011. Systematic reviews using meta-analyses to compare macrovascular events in patients with type 2 diabetes randomized to different therapeutic targets of blood glucose were eligible for inclusion in this study. Effect measures were extracted and quality was assessed by Overview Quality Assessment Questionnaire, Assessment of Multiple Systematic Reviews, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. An additional checklist was used to control for completeness and suitability of included trials, correctness of data extraction, and choice of outcome parameters. RESULTS: The 16 included systematic reviews were partially discrepant in statistical significances of reported outcome parameters. Twelve systematic reviews did not include available relevant trials and included eight systematic reviews that should not have been included according to the systematic review's aim and search strategies. Quality differed considerably among systematic reviews. CONCLUSION: Physicians, researchers, and policy makers should bear in mind that common quality assessment instruments are necessary but not sufficient to guarantee reliable results and conclusions obtained from meta-analyses.

[Does the lack of evidence of effectiveness among international studies on interventions in prevention and health promotion have an impact on a German Act of Prevention?]. / Evidenz der Wirksamkeit internationaler Präventionsmassnahmen und Auswirkungen auf ein deutsches Präventionsgesetz.

BACKGROUND AND PURPOSE: Efforts have been undertaken to devise and pass an Act of Prevention in Germany. To date, no consensus could be reached with changing political majorities in parliament. Hence, the authors ask the question whether the lack of evidence in prevention and health promotion could also be contributing to this delay. METHODS: After a systematic search of the literature on prevention and health promotion in nutrition, exercise, depression, and smoking, all retrieved studies were evaluated in terms of their effect as well as the quality of study design like prior power calculation and intervention like documentation of process or participation of intended group. For inclusion, studies had to be undertaken in one of 13 countries that have a socioeconomic standard of living comparable to Germany. The authors of this article exemplarily included studies from the following focus areas into the systematic review: prevention of depression among children and adolescents, exercise in the work environment, nutrition for children and adolescents, and smoking cessation programs among pregnant women, all from 1990 to 2006. RESULTS: The authors retrieved 18 studies on prevention of depression among children and adolescents, 26 on exercise in the work environment, 23 on nutrition for children and adolescents, and 34 on smoking cessation programs among pregnant women. Six out of 26 on exercise had a positive effect (23.1%), one out of 18 on depression (5.6%), seven out of 23 in the field of nutrition (30.4%), and nine out of 34 smoking cessation programs (26.5%). If one takes into account the quality of study design and intervention as a marker for the reliability and validity of results, one intervention on exercise, two on nutrition, three on smoking and none on depression would remain with a positive effect. CONCLUSION: In four exemplarily selected fields only six out of a total of 101 international studies (5.9%) had an effect, if one also ties in quality of study design and intervention. With regard to this result, allocation of resources for prevention and health promotion would be highly ambiguous without sufficient evidence. This condition might contribute to the deferment of an Act of Prevention in the German legislation. For the future, the authors strongly urge that the Act of Prevention takes into account the evaluation both of effects and quality of any intervention in order to prevent false allocation of resources.