Fundamentals of clinical trials

Is the use of soap and water or alcohol-based rubs more effective in preventing nosocomial infections?

Controlled clinical trial is the best research design to establish if the use of soap and water or alcohol-based rubs more effective in preventing nosocomial infections. The rational for choosing this research design is the fact that it will help identify which of the two groups, soap and water or alcohol-based rubs are more effective in preventing nosocomial infections. One group of patients can be given soap and water for hand washing while the other group is given alcohol-based rubs for hand hygiene (Friedman, Furberg, DeMets, Reboussin & Granger, 2015). To quantify the effectiveness of the two exposures, the investigator can record the incidences of nosocomial infections among the group who used alcohol-based rubs and compare the same with those who used soap and water and make appropriate conclusion.

The main strengths of a control clinical trials is the fact that appropriate comparison group is used, creating a greater confidence of accepting the overall results.  Through randomized controlled clinical trials, the researcher can recommend the most effective method to ensure hand hygiene, whether it is alcohol-based or soap and water.

However, most controlled clinical trials require complex ethical approvals since they involve the use of human beings as a subject to an experiment. One might not ethically randomize patients unless the two treatments like in the present case support the clinical community (Friedman, Furberg, DeMets, Reboussin & Granger, 2015). Clinical trials are also time consuming and more expensive when compared to other study designs.

What is the relationship between alcohol and breast cancer?

A cohort study would be the most appropriate for the present case. Cohort studies are examples of observational studies in which the beginning points are the selection of the cohort. Information is first generated to determine which members of the cohort are exposed to alcohol consumption (Sedgwick, 2014).   Women who are exposed to alcohol consumption are then followed over time and incidences of breast cancer established as appropriate. In cohort studies, individuals are classified as either exposed or not exposed. Those who take alcohol are observed over a period of time while those who do not take alcohol are also observed within the same time period and incidences of breast cancer recorded in the two groups.

The advantage of this study design is that it can be used to identify multiple outcomes associated with alcohol other than breast cancer. Moreover, cohort study identifies the relationship between the exposure and the outcome. The study design has several limitations (Sedgwick, 2014).  First, the follow-up period is too long and the subject might be lost before the study is completed. It is never suitable for rare disease and again the women can still develop breast cancer which is not caused by alcohol.

What is the difference in attitudes of male and female college students toward condoms?

Comparative cross-sectional study can be conducted to assess the difference in attitudes of male and female college students toward condoms. Comparative cross-sectional study design is one in which the researcher carries out a study only at one point in time without making a follow-up  to compare the behaviors and attitude of two or more group of population being studied (Sedgwick, 2014).  In this case, the researcher could use a well-developed questionnaire to collect information from both female and male college students regarding their attitudes towards the use of condom.

One advantage of this study design is that it is cheap and less time consuming since the study is carried out only during one point in time without making a further follow-up (Sedgwick, 2014). The only disadvantage of cross-sectional study design is that the researcher cannot explain if the attitudes had changed overtime.

 

References

Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Springer-Verlag.

Sedgwick, P. (2014). Cross sectional studies: advantages and disadvantages. BMJ: British Medical Journal, 348.

Sedgwick, P. (2014). Retrospective cohort studies: advantages and disadvantages. Bmj, 348, g1072.

 

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