More pragmatic randomized studies with a focus on registry-based trials
Randomized controlled trials (RCTs) that are highly restrictive in terms of study design, with highly selected participants and conditions, produce results whose applicability to routine clinical care and usefulness for reimbursement decisions is sometimes questioned.
In view of the background mentioned above, do more pragmatic RCTs and registry-based RCTs offer potential solutions? What are the opportunities and risks associated with more pragmatic studies and which methodological aspects should be given special attention?
Clinical RCTs for comparative effectiveness evaluation are located on a continuum from “very pragmatic” to “very explanatory”. No consented threshold exists from which an RCT is considered pragmatic. More pragmatic RCTs are often characterized by less selected but larger patient groups, embedding into a normal care setting, and patient-relevant outcomes. They usually dispense with longer-term assurance of patient adherence to the initially assigned treatment, blinding, and resource intensive intermediate examinations. However, this can lead to problems in interpretation, especially if no differences between interventions are shown.
More pragmatic RCTs and registry-based RCTs have the potential to become an important basis for decision-making in clinical practice, but also for health policy and reimbursement issues. However, in order to realize this potential, a number of hurdles – especially legal ones – have to be abolished.
|Lange S, Lauterberg J
|Prävention und Gesundheitsförderung (2022)
|This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register.
let us know
Find NEWS and PUBLICATIONS here according to your interests or use the search box.