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Designing a research study


There are 10 steps to consider in any research study. These steps can be used to perform a critical appraisal of a published paper, or to design your study in the first place. The use of a simple system such as this can ensure that biases in study design are avoided and that an appropriate study is developed.

(1) What is the study hypothesis? (2) What is the study type? (3) What are the outcome measures? Is their measurement biased in any way? (4). What is the study factor (the intervention being offered to the children)? Is there bias in this? (5) Is there a possibility of confounding? (6) What are the reference population, source population and study sample? How have the sampling and selection into the study been performed? (7) Study methods that might threaten the internal validity of the study. (8) Statistical considerations. (9) Are the results clinically and socially significant? (10) Will the conclusions of the study be relevant to the kind of patients you see, or communities you work with?

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  1. Datzins PJ, Smith BJ, Heller RF. How to Read a Journal Article.Med J Aust 1992; 157:389–394.

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Heller, R. Designing a research study. Indian J Pediatr 67, 39–41 (2000).

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Key words

  • Study hypothesis
  • Outcome measures