[Stepwise Diagnostics, Federal Joint Committee Directive and Actual Care in the Case of Sleep-related Breathing Disorders - An Analysis Based on Claims Data of the Techniker Krankenkasse]. / Stufendiagnostik nach der Richtlinie des G-BA und Versorgungswirklichkeit bei vermuteter Schlafapnoe ­ eine Analyse basierend auf Routinedaten der Techniker Krankenkasse.

In 2004, the Federal Joint Committee (G-BA) published a new directive for examination and treatment methods with respect to sleep-related breathing disorders for SHI-accredited physicians. The examination procedure is classified in four steps: anamnesis, clinical assessment, cardiorespiratory polygraphy (PG) and cardiorespiratory polysomnography (PSG). Starting with the date of the first PSG we analysed 1. whether this examination was preceded by a polygraphy, 2. whether there was a gain of diagnostic information through PSG, and 3. whether a PSG was used for the first adjustment examinations and controls after prescription of a positive airway pressure device. The analysis is based on claims data from the Techniker Krankenkasse (2009-2012). Diagnostic services were identified by fee schedule codes (EBM) for outpatient services and by procedure codes (OPS) for inpatient services. Sleep disorders were operationalised by ICD-10 codes and information was completed by prescriptions of a CPAP equipment.The study is based on data from 6.6 million persons who were permanently insured from 01.01.2009 to 30.06.2012 by TK. A preceding PG 90 (180) days before PSG was found for less than 56% (73%) of the analysed insured persons. By the latter procedure, only about 60% of the cases with no clear diagnostic information (G47.39) in the preceding quarter could be specified. Prescription of a positive airway pressure device within 90 days after PSG was found for about 45% of the insured. Concerning the stepwise diagnostic procedure for sleep disorders for SHI-accredited physicians, the directive was followed only partly. Against the background of an evidence-based, effective, and efficient diagnostic approach, the results show a clear need for action.

Potentially unnecessary and wasteful clinical trial research detected in cumulative meta-epidemiological and trial sequential analysis.

OBJECTIVE: The objective was to estimate the presence and extent to which potentially unnecessary and therefore maybe wasteful clinical trials regarding relevant interventions and outcomes in major clinical areas had been conducted. STUDY DESIGN AND SETTING: From current Cochrane collaboration systematic reviews in major medical fields (e.g., cardiovascular disease, cancer, psychiatry), 13 different comparisons were sampled. A cumulative meta-analysis was conducted for each and trial sequential analysis applied to determine when in the course of evidence accrual evidence was found sufficient to reach a reliable conclusion. Trials published afterward were considered potentially unnecessary. Sensitivity analysis is performed, for example, to determine if findings could be explained by a delayed perception of published findings when planning new trials. RESULTS: In 8/13 cases, potentially unnecessary research was detected to an extent of between 12% and 89% of all participants in trials that might not have been needed. In three of these cases with high proportions (69-89%) of potentially unnecessary research, this finding was found basically unchanged in sensitivity analysis, when only trials published 3 or 5 years after sufficient evidence had already been published were considered potentially wasteful. CONCLUSIONS: The reasonableness of claims to relevance of additional trials needs to be much more carefully evaluated in the future. Cumulative, information size bases analysis might be included in systematic reviews. Research policies to prevent unnecessary research from being done need to be developed.

Gender in health technology assessment: pilot study on agency approaches.

OBJECTIVES: Gender as a social construct is a recognized health determinant. Because best practice in reporting health technology assessment (HTA) clearly specifies the need to appraise a technology's social impact within the target population, the extent to which gender issues are taken into account in HTA production is of interest, not only in light of equitable practices but also for reasons of effectiveness. The aim of this study is to provide a first assessment of the degree of gender sensitivity shown by HTA agencies around the world today. METHODS: The Web sites of sixty HTA agencies were analyzed. The consideration of gender aspects was specifically looked for in each agency's general mission statement, its priority setting process, and its methodological approach. Additionally, specific gender-oriented initiatives not belonging to any of the aforementioned categories were identified. RESULTS: Of the sixty agencies, less than half mention a commitment to addressing the social implication of health technologies. Only fifteen institutions make information on their priority setting principles available on their Web sites and gender was an issue in two of those cases. Data on methodology were obtainable online from 18 agencies, two of which mentioned gender issues explicitly. Finally, gender-oriented initiatives were identified by thirteen agencies. CONCLUSIONS: A gender-sensitive approach is apparently rarely adopted in current HTA production. Exceptional practices and relevant tools do exist and could serve as examples to be promoted by international collaborative networks.