Observational study.

• Define an observational study.
• Describe the main types of observational studies.
• Discuss the advantages and disadvantages of observational studies.
• Define an experimental study.
• Discuss the limitations of experimental studies.

2. Compare and contrast observational studies with experimental studies.
a. Discuss at least two common issues that can affect the validity of experimental studies. Include an example for each.
b. In part 7 of this assignment, you discussed your poll/survey results. Now that you have had time to reflect on those results, what conclusions can you draw from your study?
c. Are there any confounding factors in your study? (i.e., is there an underlying reason for any surprising results?)
d. Is your poll/survey question(s) appropriate for your hypothesis? (Was there a better way you could have worded the question(s)? Did you ask the “right” question(s)?).
e. Begin to identify the limitations of your study. (Think about your poll/survey tool, sample population, sample size, etc.).
f. It is common for researchers to identify the next steps for their study in a research article. The “next steps” often address the limitations they identified in their study. Based on your work in part 8, identify some next steps for your study.
g. What type of study would you embark on for your next steps (Experimental? Observational? Which type?) Explain the rationale for your choice.

Sample Solution

Understanding Observational and Experimental Studies:

  • Define an observational study. An observational study is a type of research design where investigators observe and measure characteristics of a sample of individuals without attempting to influence or manipulate any variables. Researchers record what naturally occurs in the study population and look for associations between different factors. The key feature is the absence of intervention by the researcher.

  • Describe the main types of observational studies. The main types of observational studies include:

    • Cohort Studies: These studies follow a group of individuals (the cohort) over time to see who develops a particular outcome (e.g., a disease) and relate it to prior exposures or characteristics. Cohorts can be prospective (followed forward in time) or retrospective (data collected on past exposures and outcomes).
    • Case-Control Studies: These studies compare a group of individuals with a particular outcome (the “cases”) to a group of individuals without the outcome (the “controls”) to look for differences in past exposures or characteristics that might explain the outcome. They are typically retrospective.
    • Cross-Sectional Studies: These studies examine data on a population at a single point in time. They can assess the prevalence of a condition or the distribution of characteristics within a population. They don’t establish temporal relationships between exposures and outcomes.
    • Ecological Studies: These studies examine associations between exposures and outcomes at the population level rather than the individual level (e.g., comparing disease rates across different regions with varying levels of pollution).
  • Discuss the advantages and disadvantages of observational studies. Advantages:

    • Can study real-world situations: They observe phenomena in their natural context.
    • Useful for studying rare diseases or outcomes: Case-control studies are particularly efficient for this.
    • Can examine multiple outcomes or exposures simultaneously: Cohort studies can assess the effects of a single exposure on multiple diseases.
    • Relatively less expensive and time-consuming than experimental studies: Especially cross-sectional and case-control studies.
    • Ethically sound for studying harmful exposures: When it would be unethical to intentionally expose individuals to a risk factor.

    Disadvantages:

    • Cannot establish causality definitively: Due to the lack of manipulation, it’s difficult to determine if an observed association is causal or due to other factors (confounding variables).
    • Susceptible to bias: Various biases can affect the results, including selection bias (systematic differences between groups), information bias (errors in how data is collected), and confounding bias (other factors related to both the exposure and the outcome).
    • Difficult to control for confounding variables: Although statistical techniques can be used to adjust for known confounders, unknown or unmeasured confounders can still distort the findings.
    • Temporal ambiguity: In cross-sectional studies, it can be difficult to determine whether the exposure preceded the outcome.
  • Define an experimental study. An experimental study is a research design where investigators actively manipulate one or more variables (the independent variables or exposures) to determine their effect on an outcome variable (the dependent variable). Participants are typically assigned to different groups (e.g., treatment group and control group) using randomization to ensure that the groups are as similar as possible at the start of the study. The researchers then measure the outcome in each group and compare the results to assess the effect of the intervention.

  • Discuss the limitations of experimental studies. Limitations:

    • Ethical considerations: It may be unethical to manipulate certain exposures (e.g., exposing people to known carcinogens).
    • Feasibility and cost: Experimental studies, especially large-scale or long-term ones, can be very expensive and time-consuming.
    • Artificiality: The controlled environment of an experiment may not reflect real-world conditions, limiting the generalizability (external validity) of the findings.
    • Hawthorne effect: Participants’ behavior may change simply because they know they are being studied.
    • Difficulty in blinding: In some experiments, it may be difficult or impossible to blind participants and/or researchers to the treatment assignment, potentially introducing bias.
    • Complexity of human behavior: It can be challenging to isolate the effect of a single intervention due to the multitude of factors influencing human health and behavior.
    • Potential for selection bias (despite randomization): While randomization aims to create comparable groups, in practice, there can still be chance imbalances, especially in smaller studies.
    • Attrition: Participants dropping out of the study (attrition) can introduce bias if the reasons for dropping out are related to the treatment or outcome.

2. Compare and contrast observational studies with experimental studies.

Feature Observational Study Experimental Study
Researcher Role Observes and measures; does not intervene. Actively manipulates the exposure.
Manipulation No manipulation of variables. Manipulation of the independent variable(s).
Randomization Generally not used to assign exposures. Often used to assign participants to treatment groups.
Causality Can suggest associations but generally cannot prove it. Can establish cause-and-effect relationships more strongly.
Bias More susceptible to various biases (selection, information, confounding). Still susceptible to bias (e.g., performance, detection, attrition). Randomization helps control for known and unknown confounders.
Ethics Often used when experimental manipulation is unethical. Ethical considerations are paramount in design and conduct.
Cost & Time Generally less expensive and time-consuming. Can be more expensive and time-consuming.
Real-World Context Studies phenomena in their natural setting. Can be artificial and may not generalize well.

a. Discuss at least two common issues that can affect the validity of experimental studies. Include an example for each.

  • Confounding: A confounding variable is a factor that is related to both the independent variable (the intervention) and the dependent variable (the outcome), but is not the variable being studied. If not controlled for, a confounder can distort the apparent effect of the intervention.

    • Example: A study investigating the effect of a new exercise program on weight loss might find that the exercise group loses more weight than the control group. However, if the exercise group also consciously adopted healthier eating habits (which were not part of the exercise intervention but were correlated with it), then the observed weight loss might be due to the dietary changes rather than solely the exercise program. The healthier eating habits would be a confounding variable. Researchers try to control for confounding through randomization (to distribute confounders equally between groups) and statistical adjustments.
  • Selection Bias: Even with randomization, selection bias can occur if there are systematic differences in the characteristics of participants who are recruited into the study or who remain in the study (e.g., due to differential attrition).

    • Example: A study comparing a new therapy to standard care for depression might recruit participants who are highly motivated to seek treatment. If the participants in the new therapy group are inherently more proactive in seeking help and adhering to treatment, their improvement might be due to this underlying motivation rather than the specific therapy itself. Differential attrition could also lead to selection bias if, for instance, participants experiencing negative side effects are more likely to drop out of the new therapy group, making it appear more effective than it actually is in the broader population.

b. In part 7 of this assignment, you discussed your poll/survey results. Now that you have had time to reflect on those results, what conclusions can you draw from your study?

To answer this, I would need the specific details of the poll/survey results you discussed in part 7. Please provide a summary of your poll question(s), your sample, and the key findings. Once you provide this information, I can help you draw conclusions.

c. Are there any confounding factors in your study? (i.e., is there an underlying reason for any surprising results?)

Again, to identify potential confounding factors, I need to know the specifics of your poll/survey question(s), your hypothesis, and your results (especially any surprising ones). Confounding factors are alternative explanations for the observed associations in your data. Think about other variables that might be related to both the variable you were investigating and the outcome you measured.

d. Is your poll/survey question(s) appropriate for your hypothesis? (Was there a better way you could have worded the question(s)? Did you ask the “right” question(s)?).

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