Mother and Child Health: Research Methods. G.J.Ebrahim Editor Journal of Tropical Pediatrics, Oxford University Press . Basic Design of Clinical Trials. Cured. Same. Treatment. Sample. Randomise. Blinding. Placebo. Cured. Same. Subjects. Blocking. Variations in Basic Design -1.
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Journal of Tropical Pediatrics, Oxford University Press.
Time - Series Design
Strict for Explanatory Trials. Less strict for Pragmatic Trials
How good a compliance achieved?
Subjects who drop-out are different from those who continue
Other competing interventions?
Different rates of drop-out between groups cause under or over estimate of outcome.
Randomisation and blinding help to remove bias. Blocking needed if outcomes vary because of age, sex or other attributes.
Control of Bias -
In allocation of subjects to treatment.
In assessment of outcome.
How small a difference is clinically important?
What tests of significance will be used?
What outcome is expected in the control group?
Drop-outs and Withdrawals
How to handle them during analysis?
Population of Patients
Difference in Outcome by Chance?
Rigour of study