Epidemology

Discussion Questions:

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There are several different types of studies that can help make data from research credible and therefore useful to healthcare managers and leaders. Credible data is vital to making safe decisions. From thorough research of at least three credible sources, please discuss the following tools used in research:

Case-control studies(Case-Control Studies

Case-control studies are used when a researcher or a manager wants to determine why similar people (or organizations using managerial epidemiology) experience different outcomes. As with any research study, an initial hypothesis is developed.

Case-control studies are observational studies and include a control group that is not experiencing the issue of interest and also an experimental group that is experiencing the issue of interest. Risk factors are identified and outcomes are measured.

Case-control studies are widely used because they are typically not long term and are inexpensive. Since other more extensive, expensive studies are available, such as randomized control studies, case-control studies are not considered the most credible and are not listed high on the research hierarchy of evidence. However, they are useful in many instances when other types of studies are not feasible or when resources are scarce. Sometimes case-control studies are used as initial exploration, and if a solid cause seems clear, more extensive studies are conducted.

Interviewing two groups of people in case-control studies may provide the data necessary to determine causation. As with all research, bias can be present. Since interviews are necessary components of these studies, selection bias can occur. This happens when the researcher chooses only groups that support his or her hypothesis. To add, recall bias can be an issue. Sometimes people might not remember exact details prior to the experienced outcomes. Observer bias might also be an issue, if those conducting the study have a vested interest in the outcome supporting the initial hypothesis.

Consider a healthcare organization that is experiencing frequent staff turnover, which is costly and can affect quality care of patients. Related to this problem, an example of a case-control study is measuring staff turnover. The hypothesis is employees resigning after less than 1 year of employment due to lack of clinical experience and support from managers. The control group would be employees who are loyal to the organization and have been employees for more than 1 year. The experimental group would be employees who resign after being employed less than 1 year. Exit interviews of those resigning would provide valuable data to assess the undesired outcome.

Strength and Weakness of Case-Control Studies

Case-control studies include two groups. The case group has a specific illness or condition. The control group does not have the illness or condition. Studies include determination of exposures to each group that might have created illness or disease in the case group.)

Cohort studies, retrospective and prospective(Cohort Studies

Cohort studies begin with researchers selecting an appropriate sample to be studied. The sample group must be alike in every way possible and must not show evidence of the outcome to be studied. Cohort studies can be prospective, looking forward to events that might occur, or they can be retrospective, and gather data from what has already occurred.

Using managerial epidemiology concepts, a leader of a large trauma center might use a cohort study to refute a hypothesis that emergency department nurses working twelve-hour night shifts develop severe depression over time. The sample group would be healthy nurses working in specified department and shift, who have no clinical symptoms of depression. The leader might also narrow the study by using other characteristics, such as age range. This group would be the exposed group since they are exposed to constant trauma victims. A second group of individuals would also be followed. The second group might be admitting clerks in the business office working twelve-hour night shifts; this group would be the unexposed group.

Cohort studies follow sample groups for a specified period of time and look for new cases or new incidence, such as depression in our emergency nurse scenario. Potential problems with this type of longitudinal study can be loss of part of the group due to resignation, transfer to another department, or other reasons. Reasons for the loss might be related to the outcome being measured (depression). New nurses might be added to the group during the study timeframe.

Confounding can be a problem in any type of study. In the example above, if a nurse is diagnosed with clinical depression but also lost a loved one during the study period, the loss would be a confounding factor. Perhaps the nurse’s depression was due to loss and not due to on-the-job stressors.

Cohort studies can be expensive since the study must continue for months or even years and frequent follow-up with participants is necessary. Without frequent follow-up, recall bias can become a factor. Cohort studies can still be valuable managerial tools.

Cohort Studies

Cohort studies typically include large groups of people with the intent to determine what caused a particular condition and what risk factors might have contributed to the development of the condition. Cohort studies can be prospective or retrospective.)

Randomized clinical trials(Randomized Clinical Trials

Randomized clinical trials (RCTs) are known to be one of the most reliable types of research. To avoid selection bias, an experimental group as well as a control group is chosen at random using effective established methods. The two groups are alike in every way possible. The experimental group receives medications, procedures, or other interventions while the control group does not. Known as blinding, neither the groups nor the clinicians studying the groups know who is participating in which group. The two groups are then followed over a specified timeframe and the differences, if any, in outcomes are measured. As with any type of study, flaws can exist. With RCT, as an example, participants might drop out for various reasons, negatively affecting the makeup of a group.

If it is discovered that the experimental group is experiencing extraordinarily positive results during research, there are mechanisms in place, such as fast track, breakthrough therapy, accelerated approval, and priority review procedures. Normally, the Food and Drug Administration (FDA) can take years to approve a particular drug or treatment. As an example, if an experimental group is receiving medications to slow down multiplication of the AIDS virus and studies were showing remarkable decreases in the amount of virus present after one month, the control group then might be allowed to receive the medication after FDA approval. This seems to be the only ethical thing to do, but there was a time when fast track and other methods did not exist.

It is important to note that when human subjects are used in research, specific guidelines must be met to ensure the safety of the subjects. The clinical institution or manufacturer must establish a contract with an institutional review board (IRB). The IRB provides approval and oversight of research to ensure that laws, informed consent, safety procedures, and expected ethical standards are followed. Anyone planning to conduct research on human subjects must go through the IRB process prior to beginning research. The IRB can modify and even disapprove applications. They can also suspend research if they discover the guidelines are not being followed.

Mechanisms in Clinical Trials

As per the US Department of Health and Human Services (2018):

Under certain circumstances, the Food and Drug Administration (FDA) will prioritize or approve medications that have demonstrated potential to provide significant improvement in those experiencing undesired effects of certain medical conditions. Below you will find a chart depicting some of the processes in place to speed the approval of some medications.)

Include the following key concepts in your discussion of each study:

Data that can be collected and used by healthcare leaders and managers
Inherent biases
Cost effectiveness
Level of reliability using the hierarchy of evidence rating method
An example of the study