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Introduction (1 point): Reiterates the research questions, hypotheses. Describes the scope /organization of the research methodology section.
The occurrence of deaths in People of Color infected by COVID-19 in the United States has been surprisingly higher than other ethnicities, precisely the White ethnic group. There is a notable difference between the White ethnic group and the amount of POC infected and die of the virus. Therefore the following research question was proposed, which states: “Why is there such a disparity of COVID-19 among POC and the White ethnic group?”
Based on the research question, two hypotheses were created as follows: (1) People of color (this includes Black population and all others who identify as non-White) will be more likely to be infected with COVID-19 compared to White people. (2) People of Color infected with COVID-19 will be more likely to have negative outcomes when compared to White people.
The scope of the following methodology section includes: identifying the research design, providing examples of the type of sampling we will be using, identifying the setting where the research will be conducted, and describing the data collection methods and instruments used in collecting the data. The aim is to describe and justify the methods and statistical tools that will be used for the analysis of the collected data. Finally, the ethical considerations involved in this study will be explored as well as any resources required to implement the proposed study.
Research Design (2 points): Describes the research design/approach to be utilized in the proposed study including the rationale for its appropriateness in addressing the research questions. Cites proper methodological literature.
After careful examination of the different research designs available, the research design that best fits the research problem is the Exploratory Design. According to Kirshenblatt-Gimblett, Barbara (2006) “An exploratory design is conducted about a research problem when there are few or no earlier studies to refer to. The focus is on gaining insights and familiarity for later investigation or undertaken when problems are in a preliminary stage of investigation.” This research design relates to the research problem effectively because there is very little information on the relationship between race/ethnicity and the incidence and outcomes of COVID-19 on patients, particularly people of color (POC). The lack of data on the virus may be because COVID-19 is a new virus, and it has not been around long enough for comprehensive studying. Therefore, there is a need to further investigate in order to come to conclude. Through an exploratory design approach, researchers can create new assumptions, potential theories and hypotheses to be used as a foundation for future research (Kirshenblatt-Gimblett, Barbara, 2006).
Sample and Sampling (3 points): Explains and justifies the type of sample to be used and how participants would be selected (sampling). Describes the population. Describes the eligibility criteria (inclusion and exclusion criteria). Explains how sample size would be determined. Cites proper methodological literature.
For this study the recruitment of the participants will be done through consecutive sampling. This type of sampling involves recruiting all eligible people from an accessible population who meet the eligibility criteria over a specific time interval (Beck & Polit, 2017.) Inclusion criteria for the participants will be any adult over the age of 18 who has tested positive for COVID-19 in the state of NY from Jan 1, 2020 until November 1, 2020. Patients could both have been treated as an inpatient or as an outpatient. Exclusion criteria would be anyone under the age of 18, outside of NY state, that falls outside of our collection dates of Jan 1 to Nov 1, 2020. A biostatistician will be consulted in order to assist with an estimated sample size. In the absence of a biostatistician’s availability, a power analysis could be completed using the required formula to help prevent a Type II error (a false negative.) If unable to consult with a biostatistician or complete a power analysis to help determine the sample size, it would be best practice to obtain the largest sample size that is feasible. The sample size will be as large of a population as we can find, so the inclusion criteria has a very broad spectrum. The larger the sample size, the more representative of the population it is while creating a smaller sampling error (Beck & Polit, 2017.)
Research Setting/Context (2 points): Describes and substantiates the selection of the setting where the proposed study will be conducted.
The study will be conducted in both inpatient and outpatient settings on any person over the age of 18 who has tested positive for COVID-19 in the state of New York in order to obtain a broad representation of the patient population that is being analyzed. Moreover, the population of patients tested positive for COVID-19 will be broken down into subcategories of age, race, and disposition to draw information supporting the hypotheses.
Data Collection (3 points): Describes and justifies the data collection methods and procedures. Explains how, when, where, and by whom data would be collected.
The research study is based on the assumption that People of Color are more likely to be infected with COVID 19 than White people. In order to gather evidence to test our hypotheses , we will collect quantifiable and objective data from any entity that reports COVID-19 test results. The existing or secondary data would have come from multiple sources including hospitals, labs, drive through testing sites, outpatient clinics, primary care providers, and people who are self testing at home. All of this information is key to identifying the percentage of infected people based on race. To support the hypothesis that people of color are more likely to have a negative outcome compared to white people we would again gather our objective data from the above mentioned sources and would be able to track the mortality rate in the population being studied. In addition to examining and comparing objective data like the mortality rate amongst POC versus White people, we would send a questionnaire to the participants’ home (or via email if they have provided an email address) to obtain more data about long term disability. This would be information that the hospitals would likely not have for the population of people who tested positive but were treated as an outpatient or maybe never sought medical treatment at all. The data obtained via questionnaires could be used to obtain biophysical markers, such as, requiring the use of home oxygen in the recovery period.
Instruments (2 points): Describes and justifies the type of instrument/tool that will be used for collecting data. Includes information on the validity and reliability of the tool.
In the proposed research study, existing instruments and tools will be used for collecting data. We will collect quantifiable and objective data from the different entities mentioned above and upload all of the information into a database that will organize and analyze the obtained data. In regards to the questionnaires that will be distributed at discharge from a facility or sent to people’s homes who may have never required hospitalization, it is imperative to make sure that they are culturally appropriate for the different ethnicities we plan to capture across the board , in addition to being readable and easy to answer. The form will be short as little as 10-15 questions, as we may lose people who don’t have the time or attention span to answer long questionnaires. As a result, we must try to capture the information needed in concise questioning. Moreover, it would be important to allow the participant to remain anonymous if they choose.
Data Analysis (2 points): Describes and justifies the methods and statistical tools (if applicable) that will be used for the analysis of the collected data.
The data collected from Covid testing originating entities will be objective data uploaded into a database to be analyzed by structured programs breaking down the rate of infection in White versus POC. The objective data will also be looking at disposition: ie, not admitted, died, discharged. Once the objective information is collected, we will be able to determine how we get our questionnaires to those who did not die; for example, the questionnaire is sent home with the patient who is discharged from the hospital after an inpatient stay OR the questionnaire is emailed to the person who participate in a drive through testing site and tested positive. These questionnaires will gather both objective (ie, who was prescribed home oxygen for a period of time) and subjective data (did the person have shortness of breath as a symptom). Furthermore, It will be important to have questionnaires sent to the participants at different intervals over a period of time (ie, 2 weeks after initial diagnosis, 6 months after diagnosis, one year after diagnosis) since our research study is looking at the effects of COVID-19 on different populations of people over a period of time. The questionnaires must be structured to eliminate any potential response biases.
Ethical considerations (3 points): Describes how the rights of participants would be protected in the proposed study. Cites appropriate literature to support decisions.
When considering the ethical components of a research study there are many factors to consider. First and foremost, is the research being proposed of significant importance? We want to ensure that we are not wasting peoples’ time with research that will have no clinical significance. In our study, we feel that the data obtained by completing the study will help lay the foundation for allocating resources in the future that would help minimize and prevent the transmission of COVID -19 in the populations most vulnerable and at risk. Once we have established that our research is necessary, we must do all we can to safeguard our participants’ safety and privacy. In the case of our study, we would get informed consent from the patient or a legal guardian in order to become a participant in our study. This would give us access to data obtained from hospitals and outpatient clinics, etc, and well as provide consent for us to get our questionnaires to the participants, in whichever format they consent to (mail or email, etc). Of course, in our planning phase before even beginning our research study, we would submit our proposed research to the appropriate Institutional Review Board (IRB) whose job it is to ensure that the risks to the participants are minimal and reasonable. The selection process needs to be equitable, and informed consent is obtained and adequately documented all while maintaining the participants’ safety and privacy (Beck & Polit, 2017). In this particular research proposal, there are not a lot of additional ethical considerations (for example, we are not testing a drug and giving one group the test drug and another a placebo) that can potentially affect the patient outcome. We are doing more of an exploratory and observational study that gathers information and data to support our hypotheses. `
Resources (2 points): Describes and justifies the resources that would be needed to conduct the proposed research study.
The resources needed for this study include willing participation from entities that are doing the COVID testing. We would need to have as much participation as possible from the hospitals, outpatient clinics, home testing, drive through testing, etc in NY state to get the large sample we are looking for. Additionally, we would need financial support to pay the labor for the humans required to establish and cultivate these relationships and then employ the measures needed to collect the data necessary. Once we have the data we need from the entities themselves doing the testing, we need more humans to administer the questionnaires to participants. This will again cost more money to have these people on staff in addition to the expense of the actual questionnaires themselves (if mailing them, there are the costs associated with printing and mailing them) , and if emailed to participants there are the costs associated with using the database to send the emails and then analyze the returned questionnaires. In our planning process we would put together the projected budget to employ and complete our research in anticipation of obtaining some potential grant money to subsidize some of the costs we know we will incur.