Introduction of a Genetic Test
Objective
The main objective of this study is to assess the impact of a genetic testing model that is incorporated at the academic medical center and its appropriateness for the community hospitals.
Aims
The study primarily aims at assessing the impact of a genetic testing model in an academic medical center. Secondly, the study will attempt to check whether the outcomes of the proposed model are different between the two medical centers.
Methods
The study is done in a healthcare setting. The methods employed are therefore chosen strategically to go in line with the requirements of the health sector. For example, the data collection is done from relevant sources to avoid obtaining biased findings. Individuals who have undergone the genetic test on CYP2C9 and VKORC1 are the target population in this study. The main reason for using the population target is that the individuals are on the know concerning the issues that the study aims to address. Surveys are done on individuals who have been exposed to the test within the past five years. The responses are structured to enable analysis over every year considered in the study. Generally, the reactions take the form of the respondent’s experience before and after the test.
Study Design
The study presents the analysis of responses from individuals who have undertaken a genetic test on CYP2C9 and VKORC1 in the past five years. The responses are ordered yearly to allow for easy analysis as well as showing a clear trend on the improvement of the test procedures over the years. CYP2C9 was tested for mutations that might impact the processing and transport of proteins. On the other hand, VKORC1 was tested for mutations associated with its production in the liver. The reasons for testing are obtained from the information provided by the respondents. Moreover, the objective of the study is explained to the respondents to minimize resistance and the provision of low-quality data. Furthermore, the respondents are reached through emails and phone contacts that are obtained from the various clinics. However, respondents who cannot be reached from the provided contacts are excluded from the study. The other category of respondents who are not considered includes the respondents who have become deceased over the years. Generally, the research is done on individuals who are reachable and promise to remain available throughout the interview period. The survey materials are also used to approve the number of responses available for the study. For example, survey materials that are not having at least a fifty percent completion are not considered for the study.
Study Population
The data needed for this study has to be from the health sector. Therefore, the respondents are obtained from the health sector, such as patients and caregivers. Generally, bias arises where respondents are not picked from the field of interest. Also, the age limit of the respondents is essential in ensuring honesty in the responses obtained. Therefore, the study is contacted on a group of patients and caregivers who have interacted with the genetic test in the previous five years. The individuals considered in the study are those who were above the age of eighteen years at the time of the test. The researchers are aware of several possibilities in the outcomes after a test is done. However, the results of the tests do not constitute the selection criteria for respondents in the study.
Materials
The study is based on an analysis of information from respondents in the health sector. As such, surveys are done on the target population. The survey materials include questionnaires and flyers, explaining the aims of the study to the respondents. Moreover, a negative perception had developed among the public concerning the introduction of the genetic test. First, the additional costs and the essence of the test led to a lot of criticism from the public. Therefore, flyers were required to convince the respondents to accept to provide the necessary information. Generally, the flyers were used to form an introduction to the real questionnaires that were left voluntary. The questionnaires were developed according to the requirements of data collection policies and ensured that privacy was prioritized. Also, the age of the respondent was captured to ensure that only individuals above eighteen years old were contacted for the survey. The questionnaires were supplied through the clinics were the respondents were requested to pick at their convenience. However, phone calls were made to collect information from respondents who could not manage to access the questionnaires.
Study Endpoints, Data Collection and Analysis
The study is expected to have several endpoints. First, the analysis of the data will lead to a decision on whether the test will be introduced into the community clinic. The positive endpoint is where the research proposes positive recommendations on the contribution of a genetic test. The community clinic is affordable to most residents, and thus, a positive advice will be more beneficial. However, another endpoint is allowed for in the event the recommendations do not support the introduction of the test to the community clinic. Moreover, both endpoints are beneficial to the stakeholders. The stakeholders will decide on whether or not to invest in any of the recommendations provided in the study. The data collection stage will involve collecting the questionnaires from the respondents. After collection, the questionnaires are sorted to consider the ones with more than fifty percent completion for the study. Afterward, the data from the questionnaires are analyzed to come up with the necessary recommendations.
Study Protocol
A procedural system will be followed to ensure the success of the study. First, respondents will be recruited into the study with the age bracket being considered. Generally, the recruits are expected to have been involved in the test process within the previous five years. However, the outcome of the test is not taken as a method of measuring the eligibility of the respondent. The recruitment will be done by contacting the potential respondents through emails and phone numbers obtained from the clinic records. After the contact is made, the questionnaires are supplied to the clinics from where the respondents are advised to collect. The assumption made is that the respondents can access the hospitals. Generally, the study is paused to wait for the responses from the respondents. Then, the endpoints are addressed from the results obtained from the questionnaires. The first endpoints involved making a recommendation to advise the director to introduce the test into the community hospitals. On the other hand, another endpoint would be achieved by advising the director to forego the attempt to introduce the test. Generally, the findings in the study are used to make recommendations concerning the genetic test.