Clinical Impact Research - how to choose experimental or observational intervention study?

Area of Science:

• Health Services Research
• Clinical Research Methodology
• Public Health Evaluation

Background:

• Health and social care interventions aim to improve patient health and welfare.
• Evaluating the comprehensive impact of these interventions is crucial for optimizing healthcare delivery.

Purpose of the Study:

• To introduce and define the novel concept of Clinical Impact Research (CIR).
• To recommend appropriate study designs, specifically randomized controlled trials (RCTs) and benchmarking controlled trials (BCTs), for CIR.
• To address feasibility, validity, and generalizability considerations within CIR.

Main Methods:

• A narrative literature review formed the basis for the new CIR concept.
• Methodological studies on RCTs and BCTs informed the selection of study designs.
• Author's prior work on benchmarking controlled trials and system impact research (SIR) contributed to the framework.

Main Results:

• Clinical Impact Research (CIR) encompasses studies evaluating the health and welfare impacts of health, social care, or public health interventions.
• Key impact categories include accessibility, quality, equality, effectiveness, safety, and efficiency.
• CIR employs both RCTs (experimental) and BCTs (observational) study designs.

Conclusions:

• CIR should be prioritized in medical, health care, and health economic research.
• Evidence generated from CIR can inform clinical decisions and benefit patients and populations.
• CIR provides a scientific foundation for clinicians and leaders to enhance healthcare and public health outcomes.