DNP 825 Which epidemiological study design would you use to evaluate an intervention in your current or future practice?

DNP 825 Which epidemiological study design would you use to evaluate an intervention in your current or future practice? 

Epidemiological studies are unified by their shared goals and basis in defined populations (Yoshida, K., 2015). The case series (or register-based study) examines trends in deaths, cancers, notifiable diseases, and hospitalizations (Yoshida, K., 2015). Cohort studies produce data on disease incidence and are especially good on associations between risk factors and disease outcomes. The design and interpretation should be in the context of traditional, systematic. Meta-analytic reviews (Bröckelmann, N., 2022). one of the basic requirements of a cohort-type study is that none of the subjects have the outcome of interest at the beginning of the follow-up period. Time must pass to determine the frequency of developing the outcome. The epidemiological study approach to be applied to my future clinical practice is an observational cohort study comparing the risk of developing uterine cancer between postmenopausal women receiving hormone replacement therapy and those not receiving hormones. There is consideration of specific eligibility criteria for the participants before the start of the study: 1) they should be female, 2) they should be post-menopausal, and 3) they should have a uterus. Among post-menopausal women, a number might already have had a hysterectomy, perhaps for persistent bleeding problems, endometriosis, or prior uterine cancer.  I chose this study because, in cohort studies, investigators enroll individuals who do not yet have the health outcomes of interest at the beginning of the observation period. I assess exposure status for a variety of potentially relevant exposures. The participants are then followed forward in time as longitudinal studies rather than cross-sectional, and health outcomes are recorded. With this data, I can sort the subjects according to their exposure status for one of the exposures of interest and compare the disease incidence among the exposure categories. Cohort and case-control studies are observational studies because investigators do not allocate exposure status. Some exposures are constituents (e.g., one’s genome), some are behaviors and lifestyle choices, and others are circumstantial, such as social, political, and economic determinants that affect health (Bröckelmann N. et al., 2022). According to Bröckelmann N. et al. (2022), cohort studies more clearly indicate the temporal sequence between exposure and outcome because, in a cohort study, subjects are known to be disease-free at the beginning of the observation period when their exposure status is established. In case-control studies, one begins with diseased and non-diseased people and then ascertains their prior exposures (Yoshida, K., 2015). This is a reasonable approach to establishing past directions, but subjects may have difficulty remembering them, and their recollection may be biased by having the outcome (recall bias). Some disadvantage of cohort study includes You may have to follow large numbers of subjects for a long time, and they can be costly and time-consuming, to name a few.

Yoshida, K., Solomon, D. & Kim, S. Active-comparator design and new-user design in observational studies. Nat Rev Rheumatol 11, 437–441 (2015). https://doi.org/10.1038/nrrheum.2015.30

Bröckelmann, N., Balduzzi, S., Harms, L. et al. Evaluating agreement between bodies of evidence from randomized controlled trials and cohort studies in medical research: a meta-epidemiological study. BMC Med 20, 174 (2022). https://doi.org/10.1186/s12916-022-02369-2