In the majority of clinical settings, diagnosis, prognosis, and plan of care for an individual patient are vague and, therefore, should be expressed in terms of probability. Any research, including clinical, is influenced by randomness. Thus, clinicians should rely on observation based on solid scientific principles, including ways to reduce bias and evaluate the role of chance.
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The main type of study in the described case is a cohort study. A cohort study is an observational research in which a sampled group of people, initially united by a common feature (cohort), is observed for some time, and the outcomes in those exposed and not exposed to the intervention or other factors are compared. As described in the case, the researchers have been investigating risk factors for sudden cardiac death in a group of men and women between the ages of 35 and 70.
The time period for the study was 20 years, which highlights one of the main disadvantages of the cohort study, which is a high duration of the observation. As part of the study, participants were to provide data on demographic and behavioral characteristics yearly; they also needed to undergo testing for cardiac function and provide blood samples to assess lipid profiles and other biomarkers. With regard to clinical issues, the described research was represented by the incidence study, and the main method of assessment, in this case, was the registration of new cases during a certain period of time (DePoy and Gitlin 315).
Although cohort studies are scientifically more preferable, this approach is not always applicable to practice since such a method of research requires considerable amounts of time, effort, and money.
However, in order to assess the association between the new biomarker (inflammation) and its linkage to sudden cardiac death, the nested case-control study shall be considered (Keogh and Cox 163). The nested case-control study is a method of selection of the control group according to the case, while the control group in each case is an independent sample of the original population. The probability of inclusion in the group of “control” depends on the time during which the factor has been affecting the person in this study. This approach to study design is a form of iatric investigation, and it is frequently utilized to designate the reason for the ailment, especially in the detection of bursts of contagious sicknesses or in the studies of rare illnesses.
This type of study design is also applicable to the described research because if medical investigators need a relatively quick and easy way to learn the etiology of the new disease, they can compare the two groups of people in a rapid manner. Those who are already diseased (case) and those who were in similar conditions but did not have the disease (control) would represent the two different groups.
In a study of the new biomarkers, researchers will use the data collected in the past in order to verify the link between the specific results obtained and the suspected risk factor (Kumar 98). To check the specific cause, they will need to formulate a scientific hypothesis about how to relate the new biomarkers and the cases of sudden cardiac deaths. Then they will be able to assimilate the frequency of the trigger in the first group and the periodicity with which this cause appeared in the second group. If the risk factor occurrence dominates in the first group, it will evidence that this is the cause of the incidents.
In addition, according to the research description, one risk factor will be analyzed, in this regard, it can be argued that this type of study design is the most suitable one. This type of study is applicable to the current research because not much time will be needed for its furnishing, while the scientists will need to analyze the events that have already happened rather than wait until the new occurrences appear.
In addition, all the required information will be at the researchers’ disposal, and it would allow determining the association between the new biomarker and sudden cardiac death in a rapid way. The fast processing times imply that the case-control study is particularly useful when the research takes a long period of time due to a long investigation of the cause and the outcome (Rothman 44). Another positive aspect of this study is that it does not require a large number of individuals to get statistically crucial evidence.
However, it is worth noting that despite the fact that such a study enables checking the validity of the hypothesis of the link between the cause and the result, this type of study design is inferior to others in defining the causal link, and its strength between the risk factor and concrete results (Weiss and Koepsell 421). Therefore, the researchers are likely to use this method of research to gain an early understanding of the link to be able to conduct further research using other techniques that would be more profound and holistic in nature.
Apart from that, conducting such a study would not be as informative in nature as a prospective study type, and the researchers will need to question the reliability of the source data. However, the determination of the biomarkers will enable diminishing the subjectivity of the results. In fact, a retrospective study, in principle, cannot definitively prove the link between the phenomena and the outcome; it will only reveal a certain degree of probability of this occurrence to indicate the possibility of such a connection.
However, there are many issues that can be solved by the nested case-control study, for instance, whether a causal relationship is meaningful, or whether there is a responsivity to the hypothesis proposed by the researchers. However, the sample of the described research is within a certain range, and for that reason, it would not represent a sample of the full population; therefore, it would reduce the accuracy of the results (Hulley et al. 104). Nevertheless, no information was provided on the further course of an investigation; subsequently, it is difficult to define which study design can be applied further.
In conclusion, the main research is concerned with the cohort study design, while the hypothesis regarding the relation of sudden cardiac death and inflammation can be investigated by nested case-control studies. With the help of this study design, it would be possible to connect cases with complications such as inflammation. Further, it is a convenient type of study design while, even if testing the biomarker is expensive, the measurement will not have to be extensive. Nevertheless, some complications and limitations (deaths, dropouts) may hinder the research, and the result will not be comprehensive enough.
DePoy, Elizabeth, and Laura Gitlin. Introduction to Research, New York: Elsevier, 2013. Print.
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Hulley, Stephen, Steven Cummings, Warren Browner, Deborah Grady and Thomas Newman. Designing Clinical Research, Philadelphia: Lippincott Williams & Wilkins, 2013. Print.
Keogh, Ruth, and DR. Cox. Case-Control Studies, Cambridge: Cambridge University Press, 2014. Print.
Kumar, Ranjit. Research Methodology, Thousand Oaks: SAGE, 2014. Print.
Rothman, Kenneth. Epidemiology, Oxford: Oxford University Press, 2012. Print.
Weiss, Noel, and Thomas Koepsell. Epidemiologic Methods, Oxford: Oxford University Press, 2014. Print.