WEEK 2 RANDOMISED CONTROL TRIAL (RCT)

Introduction to Randomised Controlled Trials (RCTs)

• Purpose: Understanding the framework and applicability of RCTs in health sciences.

Learning Outcomes

• Key objectives of the topic include:

  • Understanding the concept of RCTs.

  • Distinguishing between random (probability) and non-random (non-probability) sampling.

  • Identifying sampling methods in RCTs.

  • Analyzing published RCTs for comprehension.

  • Understanding power calculations and their role in RCTs' validity.

Analyzing a Published RCT: Song & Lindquist (2015)

• Study Reference: Song, Y., & Lindquist, R. (2015). Effects of mindfulness-based stress reduction on depression, anxiety, stress and mindfulness in Korean nursing students.

• Key Sections to Review:

  • Abstract

  • Background

  • Methods (Design and Sample)

Research Investigation Using RCT Framework

• Study Aims:

  • Evaluate if a randomized controlled trial is appropriate for the research objective.

  • Identify applicable acronyms (PICO, PECO, PICo) for formulating research questions.

• Sample Evaluation:

  • Determine target population and recruited sample.

  • Compare participant profiles to a hypothetical subject (e.g., Yana).

Study Design and Sampling Methods

• Inclusion and Exclusion Criteria:

  • Identify criteria defining participant selection.

• Sampling Methods:

  • Assess if the method is random (probability) or non-random (non-probability).

  • Specify the chosen sampling method.

Flowchart for Study Implementation

• Create a flowchart illustrating:

  • Recruitment process

  • Group Allocation

  • Pre and Post-Intervention assessments

  • Measurements and Analysis

  • Participant dropout tracking

Power Calculation and Trustworthiness

• Calculating Sample Size:

  • Establish the minimum number of participants necessary to detect effects.

• Attrition Impact:

  • Analyze dropout rates and their consequences on study's statistical power.

  • Note dropout impact on drawing conclusions about the intervention's effectiveness (Type II error).

Evaluation of Internal Validity

• Analyze whether participant retention impacted statistical findings:

  • Target group size should ideally allow for sufficient power; attrition may suggest underpowered study.

Summary of Key Learning Points

• Understanding and analyzing RCTs are crucial for evidencing health interventions.

• Distinction between random and non-random sampling leads to better comprehension of study implications.

• The importance of power calculations in maintaining study credibility and reliability.

Actions Post-Class

• Review and summarize learned materials against the learning objectives.

• Complete review questions based on the referenced study.

• Draft assessments covering:

  • Study aims

  • PICO formulation

  • Inclusion/exclusion criteria analysis

  • Power calculations and participant details.

  • Randomization protocols and blinding methods

  • Data collection techniques and outcome measures

  • Statistical analysis plan and interpretation of results.