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Randomized Controlled Trial.pptx

  1. BASICS OF RCT Dr. Anil Sharma, PhD(N) Professor and Principal Manikaka Topawala Institute of Nursing- CHARUSAT, Changa Accredited Grade “A+” by NAAC 1
  2. Flow of Presentation  Understand meaning of RCT.  Illustrate Important features of RCT.  Evaluate the phases of RCT.  Take home message 2
  3. Types of Quantitative Research Design 1. Experimental Research Design i. True experimental design/ Randomized Controlled Trial a. Pre-test post-test control group b. Post-test only control group c. Solomon four group d. Factorial design e. Randomized block design f. Crossover design g. Latin square design ii. Quasi-experimental research design: a. Non-randomized control group design b. Time-series design iii. Pre-experimental research design: a. One group pre-test post-test design b. Once shot case study 3
  4. Randomized Controlled Trial (RCT)  Gold Standard  Generating scientific evidences  Designed to assess clinical intervention.  Covers three mandatory characteristics of true experimental design (Manipulation, Randomization and Control).  RCT completely balance selection bias by doing randomization control.  RCT balance the confounding variables and eliminate the influence of confounding variable (High Internal Validity) 4
  5. Three important characteristic of Randomized Controlled trial  Manipulation: Independent variable administration  Control: Two ways, keeping control group and control over extraneous variables:  Matching  Counter Balancing- all intervention to all participants but flow of intervention varies.  Homogeneity by statistical method: By using chi-square test, we assess no significant difference between two groups  Randomization: 5
  6. THREE PILLARS OF RCT 1. Randomization 2. Allocation concealment 3. Blinding 6
  7. Randomization  Randomly allocating the study participants to one of intervention group. For example: Having two groups X & Y  Generating Random Number Sequence such as XXYYXYXXXXYXYXXYY  Computer software  Random Number tables  Flipping a coin  Lottery method 7
  8. Why Randomization?  To handle Selection bias (But not a primary purpose of it)  Achieve good Baseline Balance Between Study Groups with respect to known and unknown confounders 8
  9. Allocation Concealment Generated allocation sequence and handed over to Researcher openly May create Selection Bias Hence, allocation sequence should be concealed 9
  10.  Blinding or Masking: 10 Participants Patients Reporting bias Investigator Person delivering intervention Interviewer bias Assessor Person assessing the outcome Ascertainment bias Statistician Person analyzing the data Biased reporting of result
  11.  Blinding or Masking:  Single blind trial: Participants kept blind about intervention  Double blind trial: Participants and the investigator who administered the intervention kept blind  Triple blind trial: Participants, investigator and data collector (who assess the outcome) kept blind to eliminate chances of placebo, performance and measurement bias 11
  12. Steps of Randomized Control trial (RCT) 1. Protocol development-Blue print of research study 2. Identification of population: select study population 3. Perform randomization: Core of RCT. 4. Manipulation: Implementation of intervention 5. Follow-up: On defined interval of time to ensure generalization 6. Assessment: Assessing outcome of study 12
  13. Types of Randomized Control trial (RCT) 1. Based on Outcome: 1. Clinical trial 2. Preventive trial 3. Risk factor trial 4. Cessation trial 5. Evaluation trial 2. Based on study Design: 1. Parallel group design 2. Crossover design 3. Factorial design 13
  14. Randomized Clinical trial (RCT) It has four phases: 1. Phase-I: Initial development of drug or therapy (safety, tolerance, optimal dose)- This is generally a small-scale study with simple design (Focus on developing best possible treatment) 2. Phase-II: Seeking preliminary evidence of treatment effectiveness. This phase work as assessing the feasibility of launching rigorous test. (Work as pilot study) 3. Phase-III: this is real implementation of drug or therapy at large scale to visualize the efficacy of treatment including the observation of adverse effects, if any. (Multiple sites identified to enhance the internal and external validity) 4. Phase-IV: actual assessment of external validity take place. (Check for effectiveness during widespread use of treatment) 14
  15. If you are planning to do a RCT then make sure to register your trial at CTRI (Clinical Trial Registry of India) portal of Government of India 15
  16. Any Doubt ? 16
  17. Thank You 17