Intervention Research in Healthcare introduces key aspects of interventional study design, focusing on the evaluation of health-related interventions with respect to process, safety, and efficacy/effectiveness. The course emphasizes randomized controlled trials (RCTs) as the final stage in a broader research pathway, including earlier studies addressing intervention selection, outcome measures, feasibility, sample size, inclusion rates, and expected dropout. Students learn the full process of designing and conducting RCTs, with attention to randomisation, blinding, informed consent, process evaluation, and handling missing data.

Knowledge and understanding

• Distinguish types of intervention studies (pre-/quasi-/true experimental, parallel, crossover, N-of-1, non-inferiority, pilot, pragmatic/explanatory).
• Understand rationale, history, and prerequisites of randomized trials (RCTs).
• Identify core RCT components (PICOT, randomization, blinding, control group, outcomes, follow-up).
• Formulate research questions using PICOT and translate into trial design choices.
• Select study population (eligibility, recruitment, ethics) and intervention (dose, duration, contrast, co-interventions).
• Choose outcome measures (primary/secondary, timing, validity, reliability, unintended effects).
• Understand randomization methods (fixed/adaptive: block, stratified, minimization, etc.).
• Manage protocol issues (dropouts, non-compliance, missing data, adverse events).
• Understand placebo use, run-in periods, and their advantages/disadvantages.
• Distinguish pragmatic vs explanatory trials and mixed-methods feasibility designs.
• Understand process evaluation in complex interventions.
• Apply basic trial statistics (sample size, power, ITT vs per-protocol).
• Understand trial conduct, SOPs, data management, multicenter coordination, and reporting standards.
• Recognize ethical and regulatory frameworks (e.g., GCP, ethics committees, legislation).
• Interpret trial results and assess feasibility and effectiveness.

Applying knowledge and understanding

• Critically evaluate RCT protocols and published intervention studies.
• Apply trial design methods (randomization, sample size, ethics, analysis plans, missing data handling).

Making judgments

• Critically appraise RCT reporting using CONSORT guidelines.
• Evaluate contribution of RCTs to Evidence-Based Medicine and Public Health.
• Judge applicability of intervention results across healthcare and public health settings.

Communication

• Communicate trial design, methods, and findings to expert and non-expert audiences.

Learning skills

• Develop advanced, self-directed competence in intervention research.