Health Technology Assessment (HTA)/Health Service Research:

The workshop targeted drug delivery and economy in diabetological practice (Workshop Pharmakotherapie und -ökonomie in der diabetologischen Praxis) was mainly concerned with methods and relevance of action in evidence-based medicine (Evidenzbasierte Medizin (EbM)) and Health Service Research. In the process, first of all the role of the joint federal committee (Gemeinsamer Bundesausschuss) and the institute for quality and economics in medicine (Institut für Qualität und Wirtschaftlichkeit in der Medizin) in generating pharmaceutical guidelines and evidence-based guidelines within Disease Management Programs (DMPs) were introduced as influencing factors in deciding on a therapy.

EbM, as a method for evaluating information regarding validity, importance, and applicability to the individual case, already today forms (and will gain in importance) the fundament of all medical decision processes both on the institutionel level and for the practicing physician. However, during the workshop it became clear that the meaning of the three aspects (1) validity, (2) importance, and (3) applicability to the individual case as well as their weighting may vary between the institutional and the practical medical level. While the joint federal committee of physicians and health insurance companies as also the institute for quality and economics in medicine define validity (is the given information correct?) and importance (is the given information of practical clinical relevance?) with the help of researching and reviewing published findings of surveys, the handling of the concepts validity, importance and applicability to the individual case is quite combined with a modified meaning to the practitioner. To the physician the aspect validity of information rather describes the source of a piece of information: Who provided information, does it originate from an official position, is it confirmed from official quarters? The importance of information is rather seen in this sense: Has this piece of information/guideline any meaning to my surgery (Case-mix), respectively: does this piece of information/guideline affect my representative therapy/my area of treatment? (For example, a difference in meaning of the guidelines for DMP-DM-Type-2 to an urologist and a diabetologist.) To end with, the applicability to the individual case concerns the question: How does the physician get along with the method for the particular patient?

In this context, a review of international papers on the theme of medical compliance in following evidence-based guidelines (Hasenbein, Wallesch, and Rätiger (2003)) was discussed in the workshop. The authors of this volume arrive at the conclusion that an acceptance of EbM and resulting guidelines is generally existent in the medical fraternity though the guideline compliance in practice is low. The underlying reasons are the insufficient provision for actual medical decision processes in modelling guidelines and the insufficient diffusiveness and implementation of the guidelines. Furthermore, it is detected that medical decisions differ depending on the subject to decide upon (the applicability to the individual case or the patient's risk profile/(co-)morbidity profile), the experiences of the treating physician, and the level of routine in practice (that is the importance and meaning to the patient structure in the surgery and the case-mix respectively). Hence the authors infer that guidelines are to be appropriate to a correct classification of patients.

In the continuing course of the workshop, EbM was contrasted with the aspects of Health Service Research to clarify the difference in approaches in EbM-based evaluating clinical trials and statements from observational studies. While clinical studies follow an experimental approach which defines therapy and patient population via the purpose of the examination, in observational and cohort studies treating methods are consistent with everyday conditions in practice and follow from medical judgement. Taking a look at the sciences behind the two approaches, the Health Technology Assesment (HTA) uses the method for evidence-based evaluation of information from clinical studies to deduce generally binding guidelines with high validity as well as importance and applicability to the individual case. In contrast, the Health Service Research analyses actual conditions in practice to achieve knowledge of tedium effectivity of methods and therapies. Thus the merit of Health Service Research consists of analysing everyday life in medicine in such a manner that ways of solving the problem of integrating evidence in practice are revealed. The leading thought of HTA and Health Service Research can (speaking abstractly) be considered as that of optimizing or replacing present standards.

Moreover, a concrete example of transferability of studying results to everyday practice was discussed in the workshop. With the help of published data of the Nordrhein (Altenhofen) diabetes structural treaty with more than 150.000 diabetics, published data from the Zensus-TEMPO-Study®, and a current observational study about therapy strategies for supplementary insulin therapy (PHAZIT®), average values and confidence intervals of age, duration of diabetes, HbA1c-values, blood pressure, weight, and other clinical findings were opposed.

All of the three observational studies in comparison showed very few divergencies concerning clinical findings. Accordingly, the average values of the discrete findings at the start of the PHAZIT®-Studie lie within the 95% confidence intervals of the TEMPO-Study®, firstly indicating a patient population very close to reality and practice in PHAZIT® for this kind of therapy. In a further analysis of the disease pattern, the patient populations could not only be compared in terms of single isolated diagnoses but also by means of their combinations (including severity codes) via risk stratification of the co-morbidity structure. Here, the particular studies were in agreement on the main lines as well.

Conclusions of the workshop:

The extern validity verification based on starting values for clinical findings by means of known findings taken from published cohort and/or register studies (Altenhofen et al. 2001, TEMPO-Studie®) is a fit method for checking the suitability for daily use of a survey's results. The supplementary extern validity verification as well via risk profile distribution (co-morbidities) taken from cohort and register studies in comparison with a published observational study takes another step in verifying the transferability of the results from studies to everyday practice. The extensive conformance of clinical starting findings and risk profiles is a distinct proof of the practical relevance of new results in studies. Likewise, the methods in Health Service Research can potentiate the findings in evidence-based medicine or complete them with regard to their fitness for practical use.

 

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