Epidemiologic Study Designs

• Consider an association between a risk factor and a particular health outcome that is of interest to you. Table 2.2, in Curley, has some excellent options. You may use this to guide your selection of topics or select your own population health topic.
• Then, select an observational OR experimental study design you think would be the most appropriate for exploring this association. You may select from any of the designs covered in this module.

In a 4-page paper, not including title page and references, address the following:
• Briefly identify the population health topic (association between a risk factor and a health outcome) you selected. Present a research question based on this topic that you would like to answer in a proposed study. (Consult the Walden “Developing Research” resource for guidance on crafting a research question.)
• Explain the epidemiologic study design that would be most appropriate to assess and address your population health problem.
• Summarize the data collection activities you would use (i.e., how you would collect data—online survey, paper/pen, mailing, etc.).
• Explain any specific methodologic strategies you would use. For example, if you were conducting a case-control study, how would you select your cases and controls?
• Consider the methods you would use to make these selections. What are the strengths and limitations of your selected approach?
• Explain ethical considerations pertaining to your study.

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Sample Answer

 

 

 

Investigating the Association Between Childhood Exposure to Air Pollution and Asthma Development

Introduction:

The impact of environmental factors on childhood health is a critical area of population health research. This paper focuses on the association between childhood exposure to air pollution and the development of asthma. Specifically, we will examine the research question: “Is there a significant association between chronic exposure to particulate matter (PM2.5) during childhood (ages 0-10) and the subsequent development of asthma by adolescence (ages 11-18)?”

Epidemiologic Study Design: Prospective Cohort Study

To address this research question, a prospective cohort study design would be most appropriate. This design involves selecting a group of individuals (the cohort) who are free of the outcome of interest (asthma) at baseline and following them over time to observe the development of the outcome in relation to their exposure to the risk factor (PM2.5).

  • Rationale:
    • A prospective design allows for the establishment of temporality, ensuring that exposure precedes the outcome.
    • It minimizes recall bias, as exposure data is collected before the onset of asthma.
    • It allows for the examination of multiple outcomes related to air pollution exposure.

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Data Collection Activities:

  1. Cohort Recruitment:
    • Recruit a large, representative sample of children aged 0-10 years from a defined geographic area with varying levels of PM2.5 exposure.
    • Recruitment could be done through schools, pediatric clinics, and community outreach programs.
  2. Baseline Data Collection:
    • Collect detailed information on children’s residential history, including addresses and duration of residence.
    • Obtain baseline health data, including medical history, family history of asthma, and respiratory symptoms.
    • Collect demographic information, such as age, sex, race/ethnicity, and socioeconomic status.
    • Utilize existing air quality monitoring data to estimate PM2.5 exposure at each child’s residential address during the exposure period.
  3. Follow-Up Data Collection:
    • Follow the cohort over a period of 8-10 years (until children reach adolescence).
    • Conduct annual health assessments to identify new cases of asthma, using standardized diagnostic criteria (e.g., physician diagnosis, pulmonary function tests).
    • Continuously monitor air quality data to track ongoing PM2.5 exposure.
    • Maintain contact with families through phone calls, mail, and online portals.

Methodologic Strategies:

  • Exposure Assessment:
    • Utilize geographic information systems (GIS) to link residential addresses with air quality monitoring data.
    • Employ validated air dispersion models to estimate individual-level PM2.5 exposure.
    • Consider collecting personal air monitoring data for a subsample of children to validate exposure estimates.
  • Outcome Assessment:
    • Use standardized diagnostic criteria for asthma, including physician diagnosis and pulmonary function tests.
    • Implement a rigorous case definition to ensure accurate identification of asthma cases.
    • Conduct regular quality control checks on the data collection process.
  • Confounding Control:
    • Collect data on potential confounders, such as socioeconomic status, family history of asthma, and exposure to other environmental pollutants.
    • Use statistical methods, such as multivariate regression analysis, to control for confounding.

Strengths and Limitations:

  • Strengths:
    • Establishes temporality.
    • Minimizes recall bias.
    • Allows for the examination of multiple outcomes.
    • Strongest observational study design for establishing causation.
  • Limitations:
    • Time-consuming and expensive.
    • Potential for loss to follow-up.
    • Potential for selection bias if recruitment is not representative.
    • Exposure misclassification can occur.

Ethical Considerations:

  1. Informed Consent and Assent:
    • Obtain informed consent from parents or legal guardians and assent from children who are old enough to understand the study.
    • Clearly explain the study’s purpose, procedures, and potential risks and benefits.
  2. Confidentiality and Data Security:
    • Protect the confidentiality of participant data by using unique identifiers and secure data storage systems.
    • Comply with all applicable privacy regulations (e.g., HIPAA).
  3. Potential Harms and Benefits:
    • Minimize potential harms by ensuring that data collection procedures are non-invasive and safe.
    • Maximize potential benefits by providing participants with information about asthma prevention and management.
  4. Community Engagement:
    • Engage with community members and stakeholders throughout the study process.
    • Share study findings with the community and use them to inform public health interventions.
  5. Vulnerable Populations:
    • Extra care must be taken when working with children.
    • Special consideration to low income families, and other vulnerable populations.
  6. Institutional Review Board (IRB) Approval:
    • Obtain IRB approval before initiating the study.
    • Ensure that the study protocol adheres to ethical guidelines and regulations.

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