Abstract Detail

Abstract

Randomized Controlled Trials (RCT) have been the gold standard for measuring the effects of health-care services for 50 years. However, RCTs do not describe the added value of these services for patients, but only the theoretical proof of principle (PoP) under experimental conditions. Over the last 30 years, our group has developed a strategy that can represent the benefits of all applied health services offered under the conditions of Care As Usual (CAU). Scientifically, the actual effects of CAU are referred to as Real-World Effectiveness (RWE). The appropriate method for measuring RWE is the Pragmatic Controlled Trial (PCT).
Healthcare professionals can use the PCT to describe the actual effects achieved and the values subjectively per-ceived by the patient. This job is ideal for experienced nurses who would rather use their knowledge and practical experience in the second half of their professional lives to solve complex academic challenges rather than practical ones. The central task of this new field of action is the professional collection of all data that managers need to control the healthcare system. Sound knowledge of medical procedures, decision-making criteria and the main-tenance of proportionality are necessary professional requirements. If this data collection is carried out profession-ally, it contains all the information that is regularly collected (but not always analyzed) for classic quality assurance. Therefore, traditional quality assurance could be combined with the new practice-oriented evaluation. 

The necessary steps for an unbiased analysis of RWE are explained and justified. The justifications are important because most colleagues are more interested in developing new methods than in critically analyzing achieved goals. We consider the following steps to be mandatory. (1) the standardized description of the current health problem (SDHP). (2) The description of the health risk profile of each individual patient. Imagine ten patients who all ask for your help because of the same health problem. If one compares the risk profiles (additional complaints) of these patients, clear differences are noticeable. Therefore, the complete list of individual health problems (CLIP) must be prepared for each patient at the beginning of treatment. (3) The specific (functional) GOAL of the care must be defined depending on the current disease and the individual risk profile of the patient. (4) For this purpose, it is necessary to designate the appropriate INDicator, which can decide between a functional goal that has been achieved and a functional goal that has not been achieved. A functional goal of the care of a patient suffering from osteoarthritis of the knee could be to be able to climb the two flights of stairs to his home. (5) Based on known endpoints and known risk profiles, the organizing study group selects those risk factors that have a significant (insignificant) influence on the achievement of the chosen endpoint. Patients with many "endpoint-related" risk factors are less likely to achieve the desired goal than those with insignificant or low risks. (6) Based on the descript-tion of the "Endpoint-Specific Risk Factors (ESRF)", the "Endpoint-Specific Risk Profile (ESRP)" of each patient (with the support of information technology) can be described. (7) From the large number of patients with different ESRPs, patients with comparable ESRPs can be assigned to an "Endpoint-Specific Risk Class (ESRC) with high, medium or low ESRP by forming an algorithm. This classification makes it possible to group many patients with similar risk profiles together in one ESRC each. (8) This risk classification, which only appears to be complicated, is absolutely necessary due to the considerable influence of the individual baseline risk profile of individual patients. Reliable assessments of the results are not possible without taking into account the existing risks.
Nurses who are at the beginning of their careers can also benefit from the new way of thinking that is not based on theoretical expectation, but on practical success. In parallel to the growing practical experience, they will understand that each future concept of care will require its specific strategy

Biography

1967-1974 medical school at Philipps University of Marburg/Germany

1974-1976 German Research Association (DFG) at the Ontario Cancer Institute, Toronto. 

1976-1984 Resident General Medicine / Hematology / Medical Oncology. Habilitation University Ulm. 

1985-1993 Senior Resident and supervisor Hematology / Medical Oncology 

1993-1995 Managing supervisor Department Internal Medicine University Hospital Ulm 

1985-1996 Scientific Secretary Comprehensive Cancer Center University Hospital Ulm 

1995 Foundation Working group “Clinical Economics” and member Cochrane Cooperation 

1996 Member Centers of Evidence-Based Medicine, Oxford

2005 Visiting Professor Mayo Clinic, Rochester, MN, USA

2009 Reviewer International Atomic Energy Agency (IAEA) Vienna

2009-2018 Visiting Professor Brazilian Universities UFF (Niterói), USP & UNIFESP (Sao Paulo), UNILA & UNIOESTE (Foz do Iguacu), Escola Bahiana de Medicine (Salvador). 

2013 Private Research Institute Clinical Economics Ringgold ID: 587744.