Title : “Joint option II”: Doctors can apply Care as Usual (CAU) if scientists and nurses use Pragmatic Controlled Trials (PCTs) to analyse outcomes
Abstract:
Background. A team of international cardiologists has suggested replacing the complex experimental “Randomized Controlled Trials (RCTs)” with simpler concepts named “Joint Option”. The idea is perfect, but the solution is rather difficult. Experiments overestimate the “Real-World Effectiveness (RWE)” by about 30%. The RWE describes outcomes that are influenced by two factors: the individual “Endpoint-Specific Risk Profiles (ESRPs)” of each patient and the “Individual Care Strategies (ICS)” of all physicians treating the same patient. The ESRPs have a significantly greater impact on the final outcomes than our therapies. Therefore, comparing therapies only makes sense within cohorts of patients with a common disease e.g. hypertension, similar ESRPs, and a sufficiently large population (i.e. Eco-Systems of about 100 million inhabitants) to capture the variance.
Objective. Presentation of a valid solution considering both influencing factors, the ESRPs and the ICS. This is achieved in a Pragmatic Controlled Trial (PCT), proposed as the first draft of a “Joint Option II”.
Results. The numerous and precise steps for developing a PCT are described and justified. Figure 1 illustrated the differences between experimental RCTs and Pragmatic Controlled Trials (PCTs).
Discussion: There is currently no known simple solution. However, the proposal appears to be feasible through three strategic measures. 1) The tasks of care and research are assigned to cooperative teams of doctors and nursing staff based on their interest in CAU or science and abilities. 2) Interests and abilities of nurses and doctors are different but equally important. 3) Different phases of professional career qualify employees for different tasks. The allocation of tasks based on interests and qualifications could measurably increase the efficiency of health care.
