Randomized+control+trial+(RCT)

Placebo Group by (Tamara and Rayhan) A Placebo is commonly known as an inactive substance, such as a saline solution or a sugar. Placebos are used in experimental drug studies to compare effects of an active medication to an inactive medication. In regards to a randomized control trial the placebo group is usually unaware that they have the inactive ingredient (Potter, Perry, Ross-Kerr, & Wood, 2006). Placebos can produce a 30 to 50 percent positive or negative response in people who are in the placebo group as they mentally think they are on the medication and that their health is improving and the pill is treating them this is known as a placebo effect. A placebo group is important in medical trials, because without the placebo group there is nothing to compare the treatment to for the effect. Sometimes placebos are included in prescriptions such as 28 day birth control, and the last 7 pills are a placebo, this is for individuals to stay on a schedule and remember to take a pill each day. A placebo if used outside of research is considered unethical and risks trust between health professionals and patients. =Reference = Potter, P. A., Perry, A. G., Ross-Kerr, J. C., & Wood, M. J. (2006). //Canadian Fundamentals of Nursing.// Toronto: Ann Millar.

The randomized control trial (RCT) is considered the gold standard for conducting research. Define each of the following terms as it applies to the RCT and state its importance in the overall design of the research process. Randomized (Sandra & Teresa)

Randomized Control Trial – Sandra and Teresa The randomized control trial (RCT) is a type of experiment used most often in healthcare. It is recognized as the ‘gold standard’ of experimental design when conducting research on the benefit of healthcare interventions. A randomized control experiment is a quantitative experiment often comparing an intervention (or treatment group) to a control group (that does not receive the intervention to be studied, or receives a placebo). In a randomized control trial, the experimenter randomly assigns the intervention to be received by the subjects in the experiment. The researcher is then able to study the effect of interventions on the experimental group(s) versus the control group. The differences in groups will be based solely on the intervention(s) received. The randomized assignment to a treatment group or control group reduces experimental bias. When randomization is used, the outcomes evaluated in the study will be attributed solely to the intervention(s) received rather than other differences in subjects. The outcome of a randomized control trial contributes to evidence-based healthcare practice.

__Blinded study (Evelyn & Brenda)__
Simply stated, blinding is a term that refers to keeping study participants, investigators, or those collecting outcome data in a randomized controlled trial (RCT) unaware of the assigned intervention. For example, the various stakeholders in a study on the effect of a particular medication do not know who is receiving the drug and who is receiving the placebo. Blinding is used to reduce differential assessment of outcomes or information bias. Reducing bias in a study increases the validity of the findings. Blinding participants has also been found to improve compliance and retention of study participants. Consider a situation where a drug trial participant knows he is receiving a new medication. This may result in heightened expectations or increased apprehension, both potentially affecting the physical and psychological responses of the participants. On the other hand, if investigators or caregivers are not blinded, their attitude about the study may be transferred to the participant. Lastly, the evaluation of results may be skewed if the assessor knows who has received an intervention. Sometimes there is confusion between the terms blinding and allocation concealment. The primary difference lies in the timing of keeping information confidential. Allocation concealment implies that those assigning participants to groups in a study are not aware of which group the next participant will be assigned to until the moment of assignment. This prevents selection bias which can occur if the person performing the assignment consciously or unconsciously influences the assignment process, i.e., protects the assignment sequence before and until allocation. In contrast, blinding protects the sequence AFTER allocation. Blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary participants cannot be blinded to the intervention. In contrast, allocation concealment is always possible.

** __References__ ** Devereaux, P. J., Manns, B. J., & Ghali, W. A. (2001). Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. // JAMA, 285 //(15), 2000-2003. doi: 10.1001/jama.285.15.2000 Devereaux, P. J., Manns, B. J., Ghali, W. A., Quan, H., Lacchetti, C., Montori, V. M., Bhandari, M., & Guyatt, G. H. (2001). Physician interpretations and textbook definitions of blinding terminology in randomized clinical trials. // J Am Med Assoc, 15 //, 2000-2003. doi:10.1001/jama.285.15.2000. Neutens, J. J., & Rubinson, L. (2010). // Research Techniques for the Health Sciences. // San Francisco: Pearson Education Inc. Schulz, K. F., & Grimes, D. A. (2002). Blinding in randomized trials: Hiding who got what. // Lancet, 359 //, 696-700.

Single blind (Aimee & Shannon)

A single blind study is a randomized control trial where the participants either receive a placebo or the drug that is being evaluated. (Wikipedia, n.d.) Only the researchers are aware of which intervention each participant is receiving, either the drug or a placebo (Friedman, Furberg, & DeMets, 1998). A single blind study is important to the overall design of the research process because it allows for a comparison between the test group and a control group. Advantages of this study are the health and safety of the participants are not at risk because researchers can always exercise there best judgments for the sake of the patient and the participants are not bias because they are unaware that intervention. (Friedman et al., 1998) **__ References __** Friedman, L.M., Furberg, C. and DeMets, D.L. (1998). Fundamentals of clinical trials. Retrieved September 28, 2010 from []

Wikipedia. (n.d.) Blind Experiment. Retrieved September 28, 2010 from []

Double blind (Sunshine) A double blind experiment is one in which the experimenter and the research subjects do not know if they are given the experimental treatment or if they are part of the control group. Someone other than the expeirmenter does know which participant is in each group and whether the experimenter is using the experimental treatment or the control treatment. This is done to eliminate bias by both the experimenter and the participants. It reduces the liklihood that the experimenter might give out cues to the particiants, as some participants may try to "please" the experimenter by attempting to give the responses they think the experimenter may be looking for. (Royse, 2008)

Royse, D. (2008). //Research Methods in Social Work 5th Edition//. Belmont: Thompson Higher Education.

Control group (Mary B & Mary M)
The simplest form of randomized control trials includes two groups, the intervention (experimental/treatment) group and the control (comparison) group. Subjects are selected from a defined population are randomly assigned to one of the above groups by the researcher. Subjects within the control group usually do not receive any treatment at all or may receive a different intervention from the targeted intervention group. The importance of the control group used in randomized control trials is to determine if the intervention group is affected by the treatment by comparing results with the control group (McMillan & Schumacher, 2009).

McMillan, J. H., & Schumacher, S. (2009). Research in education: Evidence-based inquiry (7th ed.). Upper Saddle River, NJ: Pearson Education.

Placebo group (Rayhan & Tamara)

Experimental group (Mohammed & Alona)  Experimental group differs from the above discussed control group. In experimental research group, the participating variable is manipulated by the researcher -- he decides and controls the interventions, treatments and conditions for this group. Research-controlled interventions are the most distinct feature of this randomized study group. The method of controlling extraneous research is generic and not unique in experimental research. The experimental group is expected to be comparable to the control group as much as possible, with the exception of the intervention. Any individual or unit of a population group has an equal chance of being part of an experimental group. The basic way the study is conducted is as follows: Observation 'before' are made on both the control and experimental groups initially. In difference to the control group, only the experimental group is exposed to the intervention before a final 'after' observation is again made on both groups. The observed difference is attributed to the intervening variable(s).

Kumar R. (2005). Research Methodology: A step-By-Step guide for Beginners. (2-nd edition). London: Sage Publications ltd. Pp 102-104.

McMillan, J. H., & Schumacher, S. (2009). Research in education: Evidence-based inquiry (7th ed.). Upper Saddle River, NJ: Pearson Education.