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Checklist for Study or Intervention Planning

Reach

(Extent of Representativeness of Participants)

In designing your study, consider purposeful sampling from diverse groups of participants (e.g. low-income, older adults, and racially-diverse) to enhance external validity.

Consider recruitment methods and intervention features that enhance the reach within populations of persons and settings.

Carefully review exclusion criteria and consider whether by excluding certain types of participants you are also decreasing ability to generalize results.

Estimating Reach and Recruitment of Individuals

  • Based on the available literature, your experience, and with formative evaluation, try to anticipate the primary barriers to participation of your program. How can you minimize or introduce methods to address these barriers in order to enhance participation?
  • Estimate the number and percentage of people in your local population that have the targeted risk factor of interest. (e.g., number and % of smokers, sedentary adults, post-myocardial infarction cases)*
  • Estimate the approximate percent of this targeted population that will be eligible due to specific study inclusion/exclusionary criteria. (e.g., of all adult hypertensives, what percent are excluded due to medication, other diseases, language barriers)*
  • Record the actual number and percent of persons excluded from your study.
  • Report the percent of eligible participants who agree to participate in your study.
  • Compare differences between those participating and those not participating on illness status, sociodemographics, geography and other key variables.
  • Record reasons that participants refused to participate in the study.

Estimating Attrition

Do the following for each study condition:

  • Record how many ____ and when (what week of the intervention) _____ subjects dropped from the study.
  • Compare differences between those completing and those not completing the study on adverse events, illness status, sociodemographics, geography, baseline scores on dependent variables, and other key variables.
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