Gemeinsamer Bundesausschuss

Using real-world data (RWD) for comparative effectiveness research has gained increasing attention. Real-world data is usually not collected with the primary aim of answering questions about the comparative effectiveness of medical interventions. Therefore, data collection is often not optimally designed for this purpose. For this reason, using it can be associated with several data-related or analysis-related problems. This article has two aims: First of all, we will outline the basic requirements for comparative non-randomized studies based on RWD. In addition, the advantages and disadvantages of potentially eligible RWD in Germany will be considered. In particular, the use of registry data will be discussed, as these currently appear to be the most suitable for comparing the effectiveness of interventions. There are now various databases in Germany that contain RWD and can potentially be used for comparative effectiveness research. If they contain all the necessary information and if the data are of sufficient quality, they could offer a timely and efficient way of determining the effectiveness of medical interventions. However, our analysis shows that the use of this data is sometimes associated with considerable limitations. RWD is often highly aggregated and thus may not be sufficiently detailed to select the subjects precisely or to emulate the intervention or control interventions satisfactorily. In addition, many data sources only encompass a limited set of variables and limited time horizons (e.g., only hospitalization) according to their intended purpose (e.g., billing). Therefore, it is often questionable whether this includes all endpoints on benefit and harm that are important for the assessment and whether sufficiently long observation horizons/follow-up periods are given. Similarly, it is often questionable whether all necessary data to avoid bias are included. Furthermore, it is often difficult to assess suitability in advance due to the lack of available information.

OBJECTIVES:To compare ICU survivors’ subjective mental and functional health before ICU admission and after discharge and to assess determinants of subjective health decline or improvement.DESIGN:Secondary analysis of the multicenter cluster-randomized Enhanced Recovery after Intensive Care trial (ClinicalTrials.gov: NCT03671447).SETTING:Ten ICU clusters in Germany.PATIENTS:Eight hundred fifty-five patients with 1478 follow-up assessments.INTERVENTIONS:None.MEASUREMENTS AND MAIN RESULTS:At two patient follow-ups scheduled 3 and 6 months after ICU discharge, patients rated their subjective mental and functional/physical health on two separate visual analog scales from 0 (worst) to 10 (best) in the previous week and before ICU admission. We compared pre-ICU and post-ICU subjective health and used mixed-effects regression to assess determinants of a health decline or improvement. At the first follow-up, 20% (n = 165/841) and 30% (n = 256/849) of patients reported a decline in subjective mental and functional health of at least three points, respectively; 16% (n = 133/841 and n = 137/849) outlined improvements of mental and functional health. For 65% (n = 543/841) and 54% (n = 456/849), mental and functional health did not change three points or more at the first follow-up. Multivariable mixed-effects logistic regressions revealed that the ICU length of stay was a predictor of mental (adjusted odds ratio [OR] per ICU day, 1.04; 95% CI, 1.00–1.09; p = 0.038) and functional health (adjusted OR per ICU day, 1.06; 95% CI, 1.01–1.12; p = 0.026) decline. The odds of a mental health decline decreased with age (adjusted OR per year, 0.98; 95% CI, 0.96–0.99; p = 0.003) and the odds of a functional health decline decreased with time after discharge (adjusted OR per month, 0.86; 95% CI, 0.79–0.94; p = 0.001).CONCLUSIONS:The majority of ICU survivors did not experience substantial changes in their subjective health status, but patients with long ICU stays were prone to subjective mental and functional health decline. Hence, post-ICU care in post-ICU clinics could focus on these patients.

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Prof. Dr. iur. Ulrich Meyer, Fürsprecher, wurde 1986 als Bundesrichter ans Eidgenössische Versicherungsgericht gewählt und gehörte dem Bundesgericht während fast 34 Jahren an. Zum Ende seiner Justizkarriere war er von 2013 bis 2016 dessen Vizepräsident und von 2017 bis 2020 dessen Präsident. Die letztere Funktion hatte er als erster Vertreter des Bundesgerichtsstandorts Luzern inne, was sich auch im Titel des Bandes widerspiegelt. Aus Anlass des 70. Geburtstags von Prof. Meyer sind im vorliegenden Band Beiträge von, mit und auch über ihn zusammengestellt, die nicht nur sein fortdauerndes wissenschaftliches Wirken dokumentieren, sondern auch vertiefte Einblicke in die richterliche Tätigkeit sowie die justizpolitischen Entwicklungen des vergangenen Jahrzehnts vermitteln. Es geht einerseits um grundlegende Tendenzen im Sozialversicherungsrecht, dem Stammgebiet des Geehrten, anderseits um die Auseinandersetzung mit den Funktionen der Justiz im modernen Rechtsstaat. Zudem finden sich persönlich gefärbte Betrachtungen über die langjährige Tätigkeit am obersten Gericht.

Im großen Sommer-Interview anlässlich des 10-jährigen Dienstjubiläums als unparteiischer Vorsitzender des Gemeinsamen Bundesausschusses sprach Prof. Josef Hecken über Entwicklungen des AMNOG, die zukünftige EU-HTA-Bewertung sowie Veränderungen beim Nutzenbewertungsprozess durch das aktuelle GKV-Finanzstabilisierungsgesetz – nachzulesen in der eben erschienenen Ausgabe von „Market Access & Health Policy“, dem Schwestermagazin von „Monitor Versorgungsforschung“. In diesem Interviewpart beschreibt Hecken seine Erfolge, aber auch das, was seiner Meinung nach nicht so gut oder auch falsch lief. Ebenso formuliert er eine klare Handlungsmaxime für die Versorgungsforschung, welche die Durchschlagskraft dieser Wissenschaftsrichtung wesentlich erhöhen würde.

BackgroundSystematic Reviews (SRs) can build the groundwork for evidence-based health care decision-making. A sound methodological quality of SRs is crucial. AMSTAR (A Measurement Tool to Assess Systematic Reviews) is a widely used tool developed to assess the methodological quality of SRs of randomized controlled trials (RCTs). Research shows that AMSTAR seems to be valid and reliable in terms of interrater reliability (IRR), but the test retest reliability (TRR) of AMSTAR has never been investigated. In our study we investigated the TRR of AMSTAR to evaluate the importance of its measurement and contribute to the discussion of the measurement properties of AMSTAR and other quality assessment tools.MethodsSeven raters at three institutions independently assessed the methodological quality of SRs in the field of occupational health with AMSTAR. Between the first and second ratings was a timespan of approximately two years. Answers were dichotomized, and we calculated the TRR of all raters and AMSTAR items using Gwet’s AC1 coefficient. To investigate the impact of variation in the ratings over time, we obtained summary scores for each review.ResultsAMSTAR item 4 (Was the status of publication used as an inclusion criterion?) provided the lowest median TRR of 0.53 (moderate agreement). Perfect agreement of all reviewers was detected for AMSTAR-item 1 with a Gwet’s AC1 of 1, which represented perfect agreement. The median TRR of the single raters varied between 0.69 (substantial agreement) and 0.89 (almost perfect agreement). Variation of two or more points in yes-scored AMSTAR items was observed in 65% (73/112) of all assessments.ConclusionsThe high variation between the first and second AMSTAR ratings suggests that consideration of the TRR is important when evaluating the psychometric properties of AMSTAR.. However, more evidence is needed to investigate this neglected issue of measurement properties. Our results may initiate discussion of the importance of considering the TRR of assessment tools. A further examination of the TRR of AMSTAR, as well as other recently established rating tools such as AMSTAR 2 and ROBIS (Risk Of Bias In Systematic reviews), would be useful.