Feasibility and Acceptability of a Multiple Risk Factor Intervention – Cancer Example

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"Feasibility and Acceptability of a Multiple Risk Factor Intervention"  is an engrossing example of a paper on cancer. The recent controversy over silicone breast implants began with the observation of breast cancer among women with implants. (2 x 5 = 10 marks) What is the advantage of using a case-control study to test the hypothesis that silicone breast implants are associated with breast cancer? The case-control study besides being a comparatively economical method is mostly applicable in preliminary researches that do not have any proven information concerning the association of the risk factor and the disease of interest (Rothman, 2012). Who should be the cases in such a study? The study’ s cases should be, Women who have undergone silicone breast implant but they are cancer-free. Cancer-free women who have not undergone silicone breast implants but having the same age as those in case (i). What groups would make appropriate controls? The appropriate control groups encompass those who have not undergone silicone breast implants but are vulnerable to the disease (Rothman, 2012).

This is especially the women at the menopausal period. What variables might be useful in a group or pair matching? Comparing or alteration variables include, Other breast implant techniques    Women age What would be the problem in choosing many variables for matching? Diverse and numerous variables each have a distinct outcome where if included in the study might yield unparalleled comparison, hence derailing the objective of the study.   An epidemiologist recently completed her Master of Clinical Epidemiology from the CCEB is interested in studying the effectiveness of a new drug ‘ D’ in the prevention of Myocardial Infarction (MI) in high-risk groups.

It has been suggested that the drug ‘ D’ given orally at a dose of 75 mg per day will lower the risk of MI.

The proposed high-risk target group is those with a past history of MI or those who have experienced recent TIAs (Transient Ischaemic Attacks) that are often a prelude to MI. The drug causes some toxicity, including chronic diarrhea and occasionally severe neutropenia (low neutrophil count which can lead to infections) and also bleeding. Hence it is important to prove a real benefit. Assume the rate of MI in an untreated group of high-risk patients is about 5/100 patients per year. Draw up a rough plan for your study.

Consider in principle, rather than in detail, the following issues: ( 2 x 6 = 12 marks) What treatments will be compared in the proposed clinical trial? Why? The study’ s selection will entail two groups both from the targeted high-risk group with a history of Myocardial Infarction (MI) where the number of participants is equal. These groups encompass, Untreated Myocardial Infarction (MI) high-risk group Treated Myocardial Infarction (MI) high-risk group (orally Drug “ D” at a capacity of 75 mg/day) Treated Myocardial Infarction (MI) high-risk group (orally Drug “ D” at a capacity of less than 75 mg/day; approximately 60mg/day) State the research question? The measure of drug “ D” effectiveness will entail outcomes’ comparison of three groups where the initial group is untreated, the second group receives 75 mg/day dose and the third a lesser dose per day (60mg).

This is to establish the overall outcomes, which include both the side effects and effectiveness of the drug with the condition of the untreated group. Research question: Will drug “ D” administered orally at a dose of 75 mg/day be effective in lowering Myocardial Infarction (MI) risks? What eligibility criteria should be used? Eligibility criteria used in this study include people with a history of Myocardial Infarction (MI) and comprise the three groups (Rothman, 2012).

Besides, they will be of the same age and free of other maladies that may blur the side, which affects the study seeks to establish like toxicity, chronic diarrhea, and occasional severe Neutropenia and bleeding. In addition, the selection will consider admitted MI participants but almost at the convalescing stage to leave the hospital. This is to ensure both administering and following of the intended outcomes is effective. What variables will you collect when a patient is entered into the study? Initial variables entail screening the physical conditions of the patients prior to the study coupled with ensuring they are fit for the exercise and free of other diseases or toxicity (Rothman, 2012).

Besides, the study will consider patients with close age brackets to shun age-related complications especially among the elderly. How will the treatment be given and how will the patients be followed? Administering of Drug “ D” is oral to the secluded participants in a hospital. The reason is to ensure effective observation of drug effects against the untreated and those who have taken a lesser dose of 60mg/day. What outcomes will you collect?

What are the time frames? Study’ s outcomes will encompass, Comparison of side effects’ outcomes across the two Drug “ D” taking groups Drug “ D” effectiveness across the three groups by observing the MI risks The study’ s timeframe will be between 4 to 5 months.   In the US Physicians study, 10000 male physicians were randomized and mortality was postulated to be 45 percent that of white males in the general population. During the first 2 years, mortality was less than 20 percent rather than the anticipated 60 percent.     How do you explain these findings? The data was erroneously interpreted which is evident from the big range of the results besides abrupt drop from 45% to less than 20% mortality. What could be done at that stage of the trial to increase the power of the study to maximize the chances of observing the small to moderate effects anticipated, which include a 20- percent reduction in total cardiovascular mortality, a 10-percent reduction in mortality from all causes, and a 30-percent reduction in cancer rates? There ought to be adequate control of variables to prevent their distributions among the randomized groups, which will augment the accuracy of the study. ii) In multiple risk factors intervention trials, 1080 endpoints were anticipated, and only 630 were observed.

Consequently, at the end of the trial, the reductions in cardiovascular deaths were statistically non-significant. What factors might have contributed to these findings? (3 marks) Factors responsible for the observation of 630 endpoints instead of 1,080 included; Inclusion of numerous variables in the study Distribution of variables in diverse subgroups, which made the anticipated endpoints deviating from, intended results (McClure, Catz, Ludman, Richards, Riggs & Grothaus, 2011).


McClure, J. B., Catz, S. L., Ludman, E. J., Richards, J., Riggs, K., & Grothaus, L. (2011). Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial. BMC Public Health, 11(1), 167-176. doi:10.1186/1471-2458-11- 167.

Rothman, K. J. (2012). Epidemiology: An introduction. New York: Oxford University Press.

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