PART 1- (1.5 pages)- Experimental Studies.
Every experiment in the United States has to be registered with ClinicalTrials.gov. Visit the clinical trials website. Select a disease(not covid-19) that is of interest to you. Search that disease in clinical trials. Select a clinical trial that is currently going on with this disease and describe the clinical trial, inclusion, and exclusion criteria. What phase is this trial? Is it single or double blind? What methods does it use (Random Clinical Trial, Community Intervention, Pre/post method or single group design). what do you think are the limitations of this trial based on what is written in the clinical trials summary of the methods
Link Below: https://clinicaltrials.gov/
PART 2 – (1.5 PAGES)-Measures Associated with Risk
Select a disease, find a peer-reviewed article that uses an observational study design.
Answer the following questions:
What is the study design?
What measures of association where used in this study?
Were these measures interpreted correctly?
PART 2 – (1.5 PAGES)-Critical Thinking About Study Design
Select a primary peer-reviewed journal article pertaining to a DIFFERENT disease of interest. Read the article. Answer the following questions:
What study design was used?
How did the study design limit the findings of the article?
Could a better study design be selected? Why or Why not?
PART 3 – (2 PAGES) -Population Attributable Risk
The PAR (population attributable risk) is often used to target behaviors or factors that will reduce the greatest morbidity of a disease. Use the chronic disease-HIV/AIDS, Address the following:
• The causes of the disease.
• What the PAR is for a list of at least 5 risk factors.
• Describe at least two examples of public health programs that are addressing some of the factors you identified as the cause of the disease.
PART 4 (1.5 PAGES) -Theories for Interpreting Cause and Effect
You are to select a DIFFERENT exposure and disease. Then use one of the modes of cause and effect to explain the relationship. Remember epidemiology is a quantitative discipline. Your answers must use appropriate epidemiological statistics to help describe the association.
Experimental Studies
Individualized Obesity Pharmacotherapy
The individualized obesity pharmacotherapy is an ongoing study aimed at identifying the specific phenotypes that health experts can use to select the appropriate medication for weight loss. The researchers recognize that obesity is a common health condition afflicting many people, and the failure to identify the specific characteristics that can help formulate a suitable treatment and management method makes it challenging to provide help to patients (“Individualized Obesity Pharmacotherapy”, n.d.). Therefore, the study aims to identify the specific phenotypes that health practitioners can use to select the appropriate drugs in order to make treatment and management of obesity more responsive to patients’ needs.
The clinical trial involves testing the efficacy of specific drugs, including phentermine-topiramate, naltrexone/bupropion, and liraglutide, on an intervention group made up of individuals suffering from obesity. Specifically, the trail entails administering phentermine-topiramate in doses of 7.5/46 mg daily, 3 mg of liraglutide, and 32/360 mg naltrexone/bupropion (“Individualized Obesity Pharmacotherapy”, n.d.). Noteworthy, the dosage highlighted above is administered to the intervention group. Among the control group, the researchers administer phentermine-topiramate, liraglutide, and naltrexone/bupropion in doses of 7.5/46 mg, 3 mg subcutaneous, and 360 mg, respectively (“Individualized Obesity Pharmacotherapy”, n.d.). In general, the study entails administering different drugs on two groups of patients in order to identify the most effective regarding the treatment of obesity.
Eligibility Criteria
Exclusion Criteria
The study involves both men and women aged 18 to 75 years. The choice of adults demonstrates that the researchers are keen not to involve those considered children under the law. In addition, capping the age of the participants at 75 indicates that the researchers are keen not to exclude individuals that can be considered too old. Others excluded from the study include people that have undergone abdominal bariatric surgery and those with a history of chronic gastrointestinal problems. People suffering from other conditions that can undermine gastrointestinal motility.
Inclusion Criteria
The study’s purpose is to investigate the specific phenotypes that can help identify the most appropriate treatment method for obesity. Accordingly, the researchers have established an inclusion criterion that can help generate the best results. To achieve this, the study includes adults suffering from obesity. Specifically, those participating should record BMI >30 Kg/m2 (“Individualized Obesity Pharmacotherapy”, n.d.). Besides, participants are required to be healthy, an aspect that can be demonstrated by the absence of controlled morbidities and psychiatric conditions (“Individualized Obesity Pharmacotherapy”, n.d.). In addition, women are required to test negative for pregnancy within 48 hours of enrolment. In conclusion, participants are required to be healthy and psychologically fit.
The study is a randomized clinical trial and has adopted a triple-blind method. As such, it revolves around the participant, investigator, and care provider. Work on the research is well on course as it is in the third phase. Based on the available information, it is evident that the study will face certain limitations. In particular, excluding obese people suffering from other conditions will deny the researchers an opportunity to collect more data.
Measures Associated with Risks
The study, “pattern of drug utilization and factors influencing long-term blood pressure control among hypertensives in a tertiary care hospital-an observational study, ” aims to identify drug use patterns among people suffering from high blood pressure. The study also aims to establish the factors that influence medication failure and the victim’s adherence to treatment procedures (Prasada et al., 2017). The study took place at the JJM Medical college and karuna trust, Karnataka. The research involved the observation and examination of hypertension patients by a consultant physician.
The study adopted a clinical study research design. Accordingly, the researchers ensured the study occurred in different phases, with each step defined by key characteristics. For instance, given that the study involves observing the patterns of blood pressure, the researchers recorded the participants’ blood pressures in three different phases. In this context, measurements were taken during the end of the 1st, 6th and 12th months of the treatment and observation period (Prasada et al., 2017). Besides recording the patients’ blood pressure, the researchers sort clearance from the relevant ethical institution as the practice with all clinical studies (Prasada et al., 2017). In general, researchers adopted a clinical study research design. This aspect is demonstrated by specific steps such as taking blood pressure in phases and seeking authority from the relevant ethical institution.
The study involved the deployment of measures of association. In particular, the researchers administered specific drugs on the participants to analyse the effect the treatment methods would have on the level of blood pressure among the concerned parties. At the beginning of the study, the researchers set the systolic and diastolic blood pressure at a level that would allow them to increase depending on the measurement phase (Prasada et al., 2017). Accordingly, the pressure was increased from 41% and 74.5% to 69 and 96% respectively at the end of the treatment period (Prasada et al., 2017). Therefore, the use of specific drugs enabled the researchers to establish the relationship between the intervention method and the blood pressure level.
In my view, the measures of association utilized in the study were measured correctly. Indeed, the researchers ensured to show the correlation between blood pressure and the different types of drugs administered to the participants. Roberts, Ashrafzadeh & Asgari (2019) contend that measures of association should quantify the correlation between two variables, an aspect that is necessary for comparison between different groups. Therefore, the researchers demonstrated that the correlation between blood pressure and the different types of drugs administered demonstrates proper interpretation.
Critical Thinking About Study Design
The study, “The rate of some complications and risk factors of diabetes in diabetic patients: Study on cases of 3218 diabetic patients”, aims to determine the rate of complications and other risk factors on diabetic patients. The researchers recognize that diabetes is a serious metabolic condition that causes damage to various body organs hence reducing one’s life expectancy (Madmoli et al., 2019). Due to the gravity of this disease, the researchers argue that it is imperative to identify the multiple risk factors and complications in order to formulate the appropriate intervention strategy (Madmoli et al., 2019). In general, the objective of the study is to investigate the multiple risk factors and complications that diabetic patients are likely to face.
The research adopted a retrospective, cross-sectional analytical research design. Accordingly, the researchers studied 3218 cases of diabetes recorded in Khatam-ol-Hospital. In order to get suitable results, the study incorporated cases that had been under the hospital’s management from 2014 to 2018 (Madmoli et al., 2019). The researcher’s primary focus was on the patients’ demographic data and clinical and laboratory records. The obtained data were analysed using SPSS version 17 (Madmoli et al., 2019). The researchers also utilized descriptive statistics and other statistical tests to analyse and interpret the data obtained from the analysis. On the whole, the study adopted a retrospective cross-sectional analytical research design, characterized by the use of statistical methods in the analysis and interpretation of data.
Although the researchers went into details in their collection and analysis of patients’ clinical and laboratory data the failure to conduct real time research that could help in the collection of independent information was a significant limitation. In my view, conducting an independent research and reducing reliance on hospital records would provide the researchers with an opportunity to interact and witness for themselves the exact conditions of diabetic patients and the risk and complications they face routinely. As such, relying on documentary evidence limited the researchers’ ability to interact with and understand the risks and complications facing diabetic patients in real life.
In my view, the use of a clinical study research design would have helped the researchers understand the nature of diabetes and the specific risks and complications facing patients. Chidambaram & Josephson (2019) contend that clinical trials help generate credible findings by eliminating bias and facilitating the identification of the most appropriate treatment methods or intervention strategies. Besides, clinical research entails interacting with patients, hence enhancing the chances of establishing the specific risk factors that lead to infections and other health complications. Accordingly, the use of a clinical study research design would help identify the specific risk factors and complications facing diabetic patients.
Population Attributable Risk (PAR)
Acquired immunodeficiency syndrome (AIDS) a chronic health condition that can be life-threatening if not well managed. AIDS is caused by the human immunodeficiency virus (HIV), which damages the immune system, hence undermining the body’s ability to defend against infections and diseases (Dawet & Onaiyekan, 2020). Noteworthy, HIV is a sexually transmitted virus, meaning that one can acquire it through unprotected sexual intercourse. Other common transmission methods include unsafe blood transfusion, sharing sharp objects such as needles, contact with infected blood, and mother to child transmission during pregnancy or birth. In sum, HIV/AIDS is a chronic disease mainly caused by a weakened immune system.
PAR For Risk Factors
The population attributable risk is one of the elements considered in eliminating exposure to infections and other factors that can causes diseases. The concept refers to the proportion of circumstances or incidences in which a population is exposed to a particular disease. The scientific community uses PAR to plan on the management of diseases, especially in eliminating risks, therefore reducing or eliminating the prevalence of a particular disease. PAR is often used in the management of the risk factors causing HIV/AIDS.
PAR For Unprotected Sex
Engaging in unprotected sex with an infected partner is one of the HIV/AIDS risk factors. Indeed, unprotected sexual intercourse exposes one to the HIV causing virus, therefore increasing the likelihood of contracting the disease if the other party is HIV positive. Unsafe sex has been identified as the main way through which one can contract the virus. For instance, according to Guy et al. (2011), the rate of HIV infections among Australian gay men engaging in unprotected anal sex has increased for the last ten years. The PAR for this risk factor is calculated based on the relationship between the hazard ratio and the risk factor i.e., engaging in unprotected sex.
PAR For Uncontrolled Alcoholism
Alcohol consumption is one of the HIV/AIDS causing risk factors. Indeed, alcohol impairs one’s judgment, making it challenging to make rational decisions about one’s health. For example, one is likely to engage in unsafe sexual intercourse when drunk. Kiwanuka et al. (2017) argue that alcohol consumers are two to five times more likely to contract HIV/AIDS compared to non-drinkers. Therefore, sensitizing people against excessive alcohol consumption can help reduce infections.
PAR for blood transfusion
Blood transfusion is a fundamental process in the provision of health services. Indeed, transfusion promotes health by enabling health providers to infuse blood into the body of a patient with a low blood volume. Unfortunately, the failure to observe safety standards during transfusion increases the likelihood of acquiring HIV, especially if the donor is positive (Wang et al., 2013). As such, the PAR for reducing HIV infections resulting from blood transfusion includes ensuring that all blood is tested for HIV before it is transfused into a patient.
Par for Sharp Objects
Sharing sharp objects such as needles with an infected person is one of the methods through which one can contract HIV/AIDS. Thus, avoiding sharing such items can reduce HIV/AIDS infections.
PAR For Mother to Child Infection
Mother to child infection during pregnancy or at the point of birth is one of the HIV/AIDS risk factors. HIV positive mothers can also transmit the virus to their children through breastfeeding (Ibobo, Chime, & Nwose, 2018). To reduce the chances of transmission, positive mothers can take HIV drugs during pregnancy, as this reduces their viral load, making it difficult to infect the young ones. Caesarean delivery is also encouraged since it reduces the risk of infecting the child. Children born to positive mothers also need to be given HIV medicine in order to reduce the chances of transmission.
Public Health Programs
Prevention of Mother-To-Child Transmission (PMTCT)
Prevention of mother to child transmission (PMTCT) is a program by the world health organization that aims to reduce mother to child HIV infections. The program also emphasizes the enactment and implementation of all the components that can help reduce HIV infections in infants and young children (Mutabazi, Zarowsky, & Trottier, 2017). Also, the program aims to address the health needs of pregnant women in order to reduce the chances of transmitting HIV to children.
National HIV/AIDS Strategy (NHAS) https://www.cdc.gov/hiv/policies/hip/hip.html
NHAS is a Unites states government program aimed at reducing HIV infections. Through the centres for disease control and prevention, the US government intends to use NHAS to advance a high impact prevention strategy that can help reduce infections using a combination of scientific, cost-effective, and scalable methods (“High-Impact HIV Prevention: CDC’s Approach to Reducing HIV Infections in the United States”, n.d.). In sum, NHAS aims to reduce HIV infections resulting from different causes.
Theories for Interpreting Cause and Effect
Generally, diseases afflicting people and other living organisms have specific causal factors. This means diseases do not just occur without a reason or specific motivation or underlying factors. According to the CDC, the diseases witnessed among people or populations do not occur randomly. Instead, the disease is likely to occur among some individuals based on the risk factors that they are exposed to (“Lesson 1: Introduction to Epidemiology”, n.d.). This aspect explains why certain diseases are likely to occur among specific populations while leaving others unaffected. The scientific community has come up with different causation models. The most common is the epidemiologic triad triangle, which is mainly used to investigate and explain infectious diseases (“Lesson 1: Introduction to Epidemiology”, n.d.). The model explains the dynamics surrounding a specific disease using three distinct elements i.e., the agent, host, and the environment. This model can be used to explain the dynamics surrounding malaria.
Malaria: Cause and Effect
Malaria is one of the most common diseases, especially in tropical Africa. The disease is caused by a parasite transmitted to human beings through the bite of an infected mosquito (World Health Organization, 2016). In this context, the mosquito plays the role of the agent. The human being becomes the host, while the environment supporting the breeding of mosquito completes their cycle as required by the epidemiologic triad triangle. Infection with malaria parasite causes several impacts. In this context, an infected person is likely to report feeling very sick with an accompanying high fever and chills (World Health Organization, 2016). In other circumstances, one is likely to shake. In general, while a parasite causes malaria, its impact on the human body manifests in high fever and chills.
Generally, the relationship between the female mosquito that carries the malaria-causing virus, the human body, and the tropical climate where malaria is prevalent demonstrates causes and effects. In this context, the mosquito transmits the virus to the human being, demonstrating how an external factor causes the disease. Upon entering the body, the parasite causes changes, as demonstrated by feeling sick, fever, and chills. In sum, the relationship between the mosquito, malaria parasite, and the human body demonstrates the concept of cause and effect.
References
Chidambaram, A. G., & Josephson, M. (2019). Clinical research study designs: The essentials. Pediatric Investigation, 3(4), 245-252.
Dawet, A., & Onaiyekan, O. E. (2020). Prevalence of malaria and some opportunistic infections in human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) patients with CD4 below 200 in Faith Alive Hospital, Jos, Plateau State, Nigeria. Int J Virol AIDS, 7, 058.
Guy, R. J., Wand, H., Wilson, D. P., Prestage, G., Jin, F., Templeton, D. J., … & Kaldor, J. M. (2011). Using population attributable risk to choose HIV prevention strategies in men who have sex with men. BMC Public health, 11(1), 247.
High-Impact HIV Prevention: CDC’s Approach to Reducing HIV Infections in the United States (n.d.) Centers for disease control and prevention (CDC) n.d. Retrieved from www.cdc.gov/hiv/policies/hip/hip.html
Individualized Obesity Pharmacotherapy (n.d.) US National Library of Medicine. Retrieved from clinicaltrials.gov/ct2/show/NCT03374956?cond=obesity&cntry=US&draw=2&rank=
Ibobo, J. A., Chime, H., & Nwose, E. U. (2018). Prevention of Mother-to-Child Transmission of HIV in Delta State of Nigeria: Evaluation of the Early Infant Diagnosis Program. Journal of Health Science Research, 3(1), 16-23.
Kiwanuka, N., Ssetaala, A., Ssekandi, I., Nalutaaya, A., Kitandwe, P. K., Ssempiira, J., … & Lindan, C. (2017). Population attributable fraction of incident HIV infections associated with alcohol consumption in fishing communities around Lake Victoria, Uganda. PloS one, 12(2), e0171200.
Prasada, R., Patil, D., Vishwanath, B. M., Shankar, A. S., Patil, U. N., & Holyachi, S. (2017). Pattern of drug utilization and factors influencing long term blood sugar control among diabetics in a tertiary care hospital-an observational study. International Journal of Basic & Clinical Pharmacology, 6(5), 1171.
Roberts, M. R., Ashrafzadeh, S., & Asgari, M. M. (2019). Research Techniques Made Simple: Interpreting Measures of Association in Clinical Research. Journal of Investigative Dermatology, 139(3), 502-511.
Lesson 1: Introduction to Epidemiology (n.d.) Centers for disease control and prevention (CDC) n.d. Retrieved from www.cdc.gov/csels/dsepd/ss1978/lesson1/section8.html
Mutabazi, J. C., Zarowsky, C., & Trottier, H. (2017). The impact of programs for prevention of mother-to-child transmission of HIV on health care services and systems in sub-Saharan Africa-A review. Public health reviews, 38(1), 28.
Madmoli, M., Dehcheshmeh, Z. M., Rafi, A., Kord, Z., Mobarez, F., & Darabiyan, P. (2019). The rate of some complications and risk factors of diabetes in diabetic patients: Study on cases of 3218 diabetic patients. Medical Science, 23(95), 63-68.
Wang, J., Liu, J., Yao, F., Wen, G., Li, J., Huang, Y., Lv, Y., Shan, H. (January 01, 2013). Prevalence, Incidence, and Residual Risks for Transfusion Transmitted HIV-1/2 Infection among Chinese Blood Donors. Transfusion, 53, 6, 1240-1249.
World Health Organization. (2016). Eliminating malaria (No. WHO/HTM/GMP/2016.3). World Health Organization.
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