NURS 8310 Week 4: EPIDEMIOLOGIC STUDY DESIGNS

Epidemiologic Study Designs

              Health problems negatively impact individuals and populations; hence, there is a need to prevent and manage them. Therefore, researchers and other stakeholders have used various strategies and methods to prevent and minimize their impacts. One such approach is research. Through using various designs, researchers and other health experts have a chance to gain a deeper insight into a public or a population’s health problems and formulate strategies to mitigate them. As part of the research, epidemiological study designs have been used to study health problems that affect individuals and populations, as well as the impact of various health interventions (Curley, 2020). Therefore, the purpose of this assignment is to identify an epidemiologic association of interest and determine a suitable study design that can be used in exploring the association.

The Population Health Topic and Research Question

 The population health topic of focus chosen for this assignment is the association between hormone replacement therapy and increased risk of breast cancer among women. Even though the prevalence of breast cancer has been dropping slightly in the last decade due to improved diagnosis, treatment, and management techniques, the disease is still a major problem that needs attention (Giaquinto et al.,2022). Hormone replacement therapy has been connected to an increased risk of breast cancer.  Hormone replacement therapy entails the use of certain medications to help replace some hormones that the body fails to sufficiently produce. In particular, combination hormone replacement therapy, which integrates the use of both progesterone and estrogen, is likely to expose the patient to increased breast cancer risk (Langer et al.,2021). Therefore, the exploration of this association will be the center of this study.

Research Question: What is the comparative risk of developing breast cancer when using hormone replacement therapy as compared to not using the therapy among postmenopausal women?

The Appropriate Epidemiologic Study Design

            It is important to identify a suitable study design that can be used to explore the problem of focus. Therefore, the most suitable design for this topic is a prospective cohort study. This is a type of design that entails following a group of people over a specified duration with the major aim of observing the development of outcomes of interest (Friis & Sellers, 2021). This design would allow a follow-up on postmenstrual women with no breast cancer at the beginning of the study. Exposure assessment can then be done by assessing the participant’s use of hormone replacement therapy and any potential changes during the study period. As part of this design, there will be a need to follow up the research subjects prospectively over a particular period of time to track the occurrence of breast cancer. Besides, it will also be important to collect data on breast cancer diagnoses through various strategies.

Data Collection Activities to Be Used

            Data collection forms an important part of any research process. Therefore, it is important to use strategies that will support a comprehensive collection of the data. As such, various strategies can be employed in this context. One of them is an interview or survey conducted at baselines. This baseline interview or survey can be used to collect demographic information such as lifestyle factors, reproductive history, and medical history, among others. It can be achieved through in-person interviews (LoBiondo-Wood & Haber, 2021). Information regarding hormone replacement therapy can also be collected at baseline, and a periodical update can be done during the follow-ups. Such data can also be collected through medical record abstraction or follow-up surveys. Medical record review will also be used to help confirm the diagnoses of breast cancer and get detailed information regarding the cases. As such, it would be easier to be more accurate regarding breast cancer cases.

The Specific Methodologic Strategies to Used and Strengths and Limitations of Selected Approach

            It is also important to explore specific methodologic strategies that can be used in exploring the research question. As earlier indicated, the chosen design is a prospective cohort study design. Therefore, particular methodological strategies will be used. One of them is selecting the study population, which will be postmenopausal women who do not have breast cancer at baseline. They can be recruited from diverse settings such as communities, population registries, and healthcare databases. 

The exposure, in this case, is hormone replacement therapy. Therefore, information reading the same would be collected at baselines, and the information will also be updated during the follow-up. It can include the type of hormone replacement therapy, dosage, duration of use, and any changes made to the therapy over time (Azam et al.,2020). It will be important to prospectively follow the patient in a bid to track the breast cancer incident cases through strategies such as electronic health records and cancer registries.  Medical record review can be used to confirm the breast cancer cases that occur during the follow-up duration. As part of exploring the association, various measures, such as relative risks or hazard ratios, will be obtained through a statistical analysis.

Particular methods used in making the selections may have both strengths and limitations. Several settings will be considered when selecting the participants. As such, recruiting participants for cohort studies would allow representative sample selection, which boosts the generalizability of the findings. However, the limitation is that there can be attrition and loss of follow-up over time, and both have the potential to introduce bias as well as negatively impact the validity of the findings (Razigalla, 2020). In assessing the exposure, prospective studies offer a platform for collecting detailed exposure information at numerous time points, hence lowering the chances of recall bias. This approach also improves the accuracy of the exposure assessment. On the other hand, the self-reported data on hormone replacement therapy can be subject to misclassification or recall bias. Besides, changes in exposure status may not be recorded in real-time, hence causing exposure misclassification.

The Ethical Consideration Pertaining to The Study

            Research ethics should always be considered when conducting research. Therefore, there are various ethical considerations pertaining to this study that will be explored. One of the central ones is informed consent. It is important that the postmenstrual women participating in the study give informed consent after they have been given important information on the aim of the study, expected procedures, and potential benefits and risks. It is also important to consider privacy and confidentiality. There is a need to ensure that the participant’s health and personal information remain confidential and private by safely storing the records, using password access, and limiting the disclosure of sensitive information to authorized individuals only (Tappen, 2022). There is also a need to ensure that the procedures used or employed during the study all contribute to the minimization of potential harm through strategies such as monitoring potential adverse events and promoting patient safety throughout the study period.

Conclusion

            This study has focused on the association between hormone replacement therapy and the risk of developing breast cancer among postmenstrual women. The chosen study design to be used for exploring this association is a prospective cohort study design. Methodology and data collection strategies have all been discussed.

References

Azam, S., Jacobsen, K. K., Aro, A. R., Lynge, E., & Andersen, Z. J. (2020). Hormone replacement therapy and mammographic density: a systematic literature review. Breast Cancer Research and Treatment, 182, 555-579. Doi: 10.1007/s10549-020-05744-w

Curley, A. L. C. (Ed.). (2020). Population-based nursing: Concepts and competencies for advanced practice (3rd ed.). Springer

Giaquinto, A. N., Sung, H., Miller, K. D., Kramer, J. L., Newman, L. A., Minihan, A., … & Siegel, R. L. (2022). Breast cancer statistics, 2022. CA: A Cancer Journal For Clinicians, 72(6), 524–541. https://doi.org/10.3322/caac.21754

Friis, R. H., & Sellers, T. A. (2021). Epidemiology for public health practice (6th ed.). Jones & Bartlett.

Langer, R. D., Hodis, H. N., Lobo, R. A., & Allison, M. A. (2021). Hormone replacement therapy–where are we now? Climacteric, 24(1), 3-10. https://doi.org/10.1080/13697137.2020.1851183

LoBiondo-Wood, G., & Haber, J. (2021). Nursing research E-book: methods and critical appraisal for evidence-based practice. Elsevier Health Sciences.

Rezigalla, A. A. (2020). Observational study designs: Synopsis for selecting an appropriate study design. Cureus, 12(1). Doi: 10.7759/cureus.6692

Tappen, R. M. (2022). Advanced nursing research: From theory to practice. Jones & Bartlett Learning.