Beruflich Dokumente
Kultur Dokumente
RANDOMIZED
CONTROL TRIAL
(RCT)
Contents
https://www.ncbi.nlm.nih.gov/pubmed/19059639
• Cohort study
Participants enrolled on basis of exposure
status
• RCT
Investigator allocates the exposure
Universitas MUHAMMADIYAH ACEH
8
FAKULTAS KESEHATAN MASYARAKAT
Intervention study characteristic
Therapeutic Preventive
• Study population • Study Population
– Patients with disease – Population at risk
• Objectives • Objectives
– Cure patients – Reduce the risk of
– Diminish symptoms developing disease
– Prevent recurrence of
disease/risk of death
1. Randomisation 5. Adherence/Contamination
• Why? 6. Outcome Assessment
• How? 7. Loss to Follow up
• Who? 8. Analysis
2. Allocation concealment • Intention to treat Analysis
3. Intervention • Per Protocol Analysis
4. Blinding/Masking
Different phases
• Follow-up
– Maintainence and assessment of adherence
– High and uniform rates of ascertainment
• Experimental population
– The actual group in which the trial is conducted
– Sample size
– Sufficient number of outcome (endpoints)
– Possibility for accurate follow up of information
during the trial
• Willing to participate
– Informed consent
Reference population
Experimental population
Exclusion criteria Excluded
Informed consent Refused
Study population
Random allocation
Outcome
• Different comparisons:
– Another dosage of same drug
– Another therapy or program
– Continuation of standard medical practise
– Placebo
– Nothing …….
• Allocation by randomization
• Simple randomization
– First option
• Stratified randomization
– Classified into subgroups before randomization
– Randomize within subgroups
– (if sample size is limited)
> blocking
• Methods:
– Table of random numbers
– Computer generated randomization-list
– Sealed envelopes
– Telephone lists
– ………..
• Blinding
– Hiding information about the allocated study
regimes from key participants in a trial
– Depending on outcome of interest
– Ethics, feasibility, compromise
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2947122/
• Placebo
– Inert medication or procedure, i.e
– No effect
– Intended to give the patient the perception they are
receiving treatment
• Single – blind
– Observer or subject are kept ignorant about allocated
study regime
• Double blind
– Both observer and the subject are kept ignorant about
allocated study regime
• Advantage
– Answer two or more questions in a single
trial for only a marginal increase in cost
• Should not
– Complicate trial operation
– Affect eligibility reqirements
– Cause side effects – poor adherence
– Interaction between study regimes
• Introduction
Background/Justification, Research Question, Aim, Hypothesis
• Methods
Study Design, study sample, exposure and outcome measurement,
analysis planning
• Analysis
• Results
Primary & Secondary results (tables, graphs)
• Discussion
What results mean, comparison with previous results, what went wrong in
the study, what are the implications
Reference population
Experimental population
Exclusion criteria Excluded
Informed consent Refused
Study population
Random allocation
Outcome
• Ethics
– Sufficients doubts to withold from half the population
– Sufficient believes to expose half the population
– Requires high scientific standards
– Nuremberg Code, 1947
– Human Research Ethics Committee/Institutional Review
Board
• Feasibility
– Widespread adaption of measures by community
– Problems of finding sufficiently large eligible sample size
• Costs
– Expensive
Design: Pregnant women over the age over the age of 35 would be given
both an ultrasound and amniocentesis. The results of the tests would be
recorded and the number of true positives and negatives versus the false
positives and negatives would be calculated