[Linkage of Clinical and Claims Data in the Evaluation of Post-Stroke Care - SeDaStro: Experiences from the Tyrolian StrokeCard Program]. / Linkage von klinischen Primärdaten und Krankenkassenabrechnungsdaten in der Evaluation der Schlaganfallversorgung ­ SeDaStro: Erfahrungen aus dem Tiroler StrokeCard-Programm.

AIMS AND OBJECTIVES: Data linkage is of paramount importance in the evaluation of treatment regimens for chronic diseases where different health care sectors are involved. A comprehensive picture of long-term treatment effects and, in particular, the cost-effectiveness ratio of treatment approaches can only be drawn when data from various sources are merged and analyzed together. METHODOLOGICAL PROBLEMS AND CHALLENGES: Regarding post-acute stroke care, the present study gives an example of an exact deterministic data linkage procedure including clinical patient records and claims data of TGKK, the main Tyrolean statutory health insurance fund. Typical problems known from other data linkage projects also emerged in the so-called StrokeCard program conducted at the Medical University of Innsbruck. Distinctive Austrian features (the majority of the Austrian population benefits from a mandatory social insurance system without freedom of choice) facilitated the feasibility of the data linkage procedures. RESULTS: Over the recruitment period 01/2014-12/2015, 540 patients could be assigned to the operative dataset. Of these, 367 patients were part of the StrokeCard group (i. e. the treatment group), and 173 belonged to the usual care group (i. e. the control group); 11 patients did not complete the one-year follow-up period (7 treatment group patients vs. 4 control group patients); 7 of them died during the study (5 treatment group patients vs. 2 control group patients). For all 540 patients, TGKK claims data were available for the time-frames of one year before recruitment and one year after discharge from the University hospital. All data could be used in the health-economic evaluation of the StrokeCard program. CONCLUSIONS: The linking of clinical patient records with data collected by SHI funds opens a window of opportunities for analyses of medical care. Counter-intuitively, Austrian health services research activities have limited experience in data linkage approaches, alhough studies based on the linkage of clinical patient records and claims data are indispensable for the evaluation of complex multi-sectoral treatment schemes. The current project proves the feasibility of data linkage mechanisms in the Austrian context. This should be regarded as an impetus for extending data linkage principles to evaluation studies in the future.

Health technology assessment of utilization, practice and ethical issues of self-pay services in the German ambulatory health care setting.

OBJECTIVES: The provision of self-pay medical services is common across health care systems, but understudied. According to the German Medical Association, such services should be medically necessary, recommended or at least justifiable, and requested by the patient. We investigated the empirical evidence regarding frequency and practice of self-pay services as well as related ethical, social, and legal issues (ELSI). METHODS: A systematic literature search in electronic databases and a structured internet search on stakeholder websites with qualitative and quantitative information synthesis. RESULTS: Of 1,345 references, we included 64 articles. Between 19 and 53 % of insured persons received self-pay service offers from their physician; 16-19 % actively requested such services. Intraocular pressure measurement was the most common service, followed by ultrasound investigations. There is a major discussion about ELSI in the context of individual health services. CONCLUSIONS: Self-pay services are common medical procedures in Germany. However, the empirical evidence is limited in quality and extent, even for the most frequently provided services. Transparency of their provision should be increased and independent evidence-based patient information should be supplied.

Scanning the horizon: development and implementation of an early awareness system for anticancer drugs in Austria.

BACKGROUND: Due to increasing expenditures for cancer therapies, an instrument was needed in Austria to facilitate the evidence-based use of new anticancer drugs and to pre-estimate their financial implications. OBJECTIVES: To describe and analyse the development and implementation of a Horizon Scanning System (HSS) in Austria that allows for the evaluation of new anticancer drugs before their routine introduction into clinical practice in order to inform decision-makers. METHODS: Common stages involved in HSSs were identified by a literature review and in cooperation with experts. A first concept for an HSS in Oncology was developed and piloted, and further adjustments were made after several feedback rounds with experts in oncology. RESULTS: To specifically tailor the five common stages of HSSs to the needs of our HSS, a continually evolving process was required. Now, 21 information sources are regularly scanned, the information is retrieved and extracted in a standardised format, and only anticancer drugs in phase III are included and prioritised by a team of eight experts. Since the HSS in Oncology was implemented as a standard practice, 19 assessments on novel cancer therapies with likely therapeutic and/or financial impacts have been published. CONCLUSIONS: The successful implementation of an HSS necessitates a repetitive cycle of adjustments in order to meet the objectives set by the individual HSS.

Individual health services.

BACKGROUND: The German statutory health insurance (GKV) reimburses all health care services that are deemed sufficient, appropriate, and efficient. According to the German Medical Association (BÄK), individual health services (IGeL) are services that are not under liability of the GKV, medically necessary or recommendable or at least justifiable. They have to be explicitly requested by the patient and have to be paid out of pocket. RESEARCH QUESTIONS: The following questions regarding IGeL in the outpatient health care of GKV insurants are addressed in the present report: What is the empirical evidence regarding offers, utilization, practice, acceptance, and the relation between physician and patient, as well as the economic relevance of IGeL?What ethical, social, and legal aspects are related to IGeL? FOR TWO OF THE MOST COMMON IGEL, THE SCREENING FOR GLAUCOMA AND THE SCREENING FOR OVARIAN AND ENDOMETRIAL CANCER BY VAGINAL ULTRASOUND (VUS), THE FOLLOWING QUESTIONS ARE ADDRESSED: What is the evidence for the clinical effectiveness?Are there sub-populations for whom screening might be beneficial? METHODS: The evaluation is divided into two parts. For the first part a systematic literature review of primary studies and publications concerning ethical, social and legal aspects is performed. In the second part, rapid assessments of the clinical effectiveness for the two examples, glaucoma and VUS screening, are prepared. Therefore, in a first step, HTA-reports and systematic reviews are searched, followed by a search for original studies published after the end of the research period of the most recent HTA-report included. RESULTS: 29 studies were included for the first question. Between 19 and 53% of GKV members receive IGeL offers, of which three-quarters are realised. 16 to 19% of the insurants ask actively for IGeL. Intraocular tension measurement is the most common single IGeL service, accounting for up to 40% of the offers. It is followed by ultrasound assessments with up to 25% of the offers. Cancer screening and blood or laboratory services are also frequent and represent a major proportion of the demand. The ethical, social, and legal aspects discussed in the context of IGeL concern eight subject areas: autonomous patient decisions versus obtrusion,commercialization of medicine, duty of patient information, benefit, evidence, and (quality) control, role and relation of physicians and patients,relation to the GKV, social inequality,formally correct performance. For glaucoma screening, no randomized controlled trial (RCT) is identified that shows a patient relevant benefit. For VUS three RCT are included. However, they do not yet present mortality data concerning screened and non-screened persons. VUS screening shows a high degree of over-diagnosis in turn leading to invasive interventions. To diagnose one invasive carcinoma, 30 to 35 surgical procedures are necessary. CONCLUSION: IGeL are a relevant factor in the German statutory health care system. To provide more transparency, the requests for evidence-based and independent patient information should be considered. Whether official positive and negative-lists could be an appropriate instrument to give guidance to patients and physicians, should be examined. Generally, IGeL must be seen in the broader context of the discussions about the future design and development of the German health care system.