Answer 1 Of CASP
The standards for carrying out a clinical trial is represented by the PICOTS, where P stands for Population, I stands for Interventions, C stands for Comparators, O stands for Outcomes, T stands for Timing and S stands for Settings. It is necessary to select an appropriate population for study in clinical trials in order to identify the high risk individuals. Considering a large group of populations helps the clinicians to identify the effects of the trial on a majority of the population. A population is selected based on an inclusion and exclusion criteria. It is essential to select an appropriate intervention as well as a comparator in order to compare the intervention tested with other known and legitimate interventions. This helps to determine the effectiveness of the intervention with respect to the ones already reported. Moreover, it also helps to determine the adverse effects of the interventions on the patients and enables the use of an alternative approach in addressing the patient needs. Legitimate outcomes having a broad range of effects over a long period of time is essential. It is necessary to standardize the outcomes according to symptoms. The timing describes the duration taken for the data collection. Setting represents the area where the clinical interventions can be applied. These can be primary, inpatient settings or specialty care settings (Riva et al. 2012).
Answer 2 Of CASP
A randomized clinical trial can be described as the study in which the patients or the participants are assigned to different groups and each group is subjected to a treatment. The groups are similar and as a result, the treatments applied can be compared effectively. The allocation of the participants to the different groups remains concealed from the clinicians and the researchers. Moreover, the researchers and the clinicians cannot choose the groups, where the participants are to be allocated. Random allocation of participants in different groups helps to reduce selection bias, when carrying out studies to determine the effectiveness of an intervention. One group is always kept as a control or no treatment group and other is the placebo that receives the standard treatment. Based on the results of these two groups the effects of the new treatment are compared. Except for the treatment options all the other variables are kept constant in a randomized control trial. In order to prevent selection bias, the allocation into various groups remain concealed from the clinicians or the researchers. Thus, the importance of a randomized control trial is to determine and compare the effectiveness of various interventions in addressing a common medical condition. It also helps to determine the adverse effects of the treatment on the study populations (Rosenberger and Lachin 2015).
Answer 4 Of CASP
Blinding is the technique followed in randomized clinical trials that prevent the study personnels, clinicians or health workers and patients to know which intervention is provided to which group. However, every time a randomized clinical trial cannot include blinding, particularly if patients are actively involved in the administration of the interventions. Blinding in randomized clinical trials can be classified as single blinding, double blinding and triple blinding (Hulley et al. 2013). A single blind trial is the one in which treatment or interventions are concealed from the patients. A double blind trial is the one where both the patients as well as the researchers are unaware of the interventions. The triple blind trial is the one in which the patients, researchers as well as the clinicians or health workers are concealed from the treatments or interventions being studied. However, randomized control trials can also be unblinded, where the treatment or the intervention details are made available for patients, clinicians and researchers. A single blinded study is the same as an unblended study on the basis of advantages, however, in the case of a double or triple blind trial, the risk of bias is reduced as the study personnel or the researcher treats both the experimental and the control groups in the same manner (Page and Persch 2013).
Hulley, S.B., Cummings, S.R., Browner, W.S., Grady, D.G. and Newman, T.B., 2013. Designing clinical research. Lippincott Williams & Wilkins.
Page, S.J. and Persch, A.C., 2013. Recruitment, retention, and blinding in clinical trials. American Journal of Occupational Therapy, 67(2), pp.154-161.
Riva, J.J., Malik, K.M., Burnie, S.J., Endicott, A.R. and Busse, J.W., 2012. What is your research question? An introduction to the PICOT format for clinicians. The Journal of the Canadian Chiropractic Association, 56(3), p.167.
Rosenberger, W.F. and Lachin, J.M., 2015. Randomization in clinical trials: theory and practice. John Wiley & Sons.