The twin-method enables the assessment of real-world effectiveness and may trigger a paradigm shift in health care and health professions.

Title : The twin-method enables the assessment of real-world effectiveness and may trigger a paradigm shift in health care and health professions.

Abstract:

The available standard tools for outcome assessment can measure the "proof of principle" of a new intervention under experimental study conditions. The new method of a Pragmatic Controlled Trial (PCT) is an observational TWIN-METHOD (1) that allows the application of health care as usual under the unstructured conditions of the "Natural Chaos" where almost all patients and all doctors' strategies are different and second, the assessment of outcomes under well-structured conditions.

This “squaring of a cycle” is possible by replacing the Randomized Controlled Trial (RCT) with the Bayes' principle. All patients will be treated according to the best of the health care team's knowledge. However, each patient needs to be classified at study entry. The classification describes the individual risk of each patient related to her/his risk profiles (high, intermediate, low) to each of the assessed study endpoints (e.g., survival, major side effect, monetary costs). This endpoint-specific risk classification will provide more detailed and more reliable information on the effects of treatments than RCTs.

The new method will change several of our current standards in health care and health legislation. The TWIN-METHOD will be the first and a specific tool of Health Services Research (HSR). HSR is a field of medicine that combines both care under real-world conditions and outcomes research under well-structured but non-experimental (observational) conditions. We will get precise data not only on efficacy but also on effectiveness and efficiency. Legal decisions will be based no longer on experimental data but on Real-World Outcomes. To achieve these aims we need experts who can retrieve these data in out-patient clinics and hospitals. The best-suited profession to complete this challenging task may be nurses with a feeling for patient needs, medical practice, and information technology.

Reference

1. Porzsolt F, Weiß C, Weiss M. Covid-19: Twinmethode zum Nachweis der Real-World Effectiveness (RWE) unter Alltagsbedingungen [Covid-19: Twin Method for Verifying Real-World Effectiveness Under Everyday Conditions]. Gesundheitswesen. 2022 Jun 23. German. doi: 10.1055/a-1819-6237. Epub ahead of print. PMID: 35738304. 

Biography:

Medical degree at Philipps-University of Marburg/Germany 1975, research grantee The Ontario Cancer Institute, Toronto/ONT 1975/76, trained as hematologist/medical oncologist University of Ulm/Germany. Development of a tools to confirm the effects under real world conditions that were claimed in the scientific literature but nit generated under real world but under ideal study conditions. The new tool was named “Pragmatic Controlled Trial (PCT)”. He also developed the concept of “Perceived Safety” and described the “Safety Loop” connecting objective risks with its subjective perception (= safety), and the Y-Nurse concept. These considerations were summarized in a new medical field “CLINICAL ECONOMICS”, which is not about money but about value form the perspectives of the individual patients and the society. This concept was honored in 2012 by the German IQ-award by MENSA - Deutschland. In 2013 he founded the scientific society “Institute of Clinical Economics (ICE) e.V.”