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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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mother and child health research methods

Mother and Child Health: Research Methods

G.J.Ebrahim

Editor

Journal of Tropical Pediatrics, Oxford University Press.

basic design of clinical trials
Basic Design of Clinical Trials

Cured

Same

Treatment

Sample

Randomise

Blinding

Placebo

Cured

Same

Subjects

Blocking

variations in basic design 1
Variations in Basic Design -1

Run-in Design

Admission

On placebo

Compliers randomised

A

S

S

E

S

S

A

S

S

E

S

S

Cross-over Design

Treatment 1

Recruitment

Randomised

Treatment 2

variations in basic design ii
Variations in Basic Design - II

Time - Series Design

No Treatment

Recruitment

Treatment

Treatment

Assess

Assess

Assess

Low Dose

Factorial Design

Treatment 1

High Dose

Recruitment

Randomise

Treatment 2

Low Dose

High Dose

issues of methodology i
Issues of Methodology - I

Entry Criteria

Strict for Explanatory Trials. Less strict for Pragmatic Trials

Diagnosis

How accurate?

Interventions

How good a compliance achieved?

Subjects who drop-out are different from those who continue

Other competing interventions?

issues of methodology ii
Issues of Methodology - II

Subject Allocation

Different rates of drop-out between groups cause under or over estimate of outcome.

Treatment Allocation

Randomisation and blinding help to remove bias. Blocking needed if outcomes vary because of age, sex or other attributes.

challenges in designing clinical trials
Challenges in Designing Clinical Trials

Control of Bias -

In allocation of subjects to treatment.

In assessment of outcome.

Sample Size

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?

generalizability of results
Generalizability of Results

Treated

Outcome

Sample

Population of Patients

Control

Outcome

Difference in Outcome by Chance?

Rigour of study

Other

Populations

Generalisability