Source:
“Design of Randomized Controlled Trials” Kenneth Stanley. http://circ.ahajournals.org/content/115/9/1164. Introduction:
This Article review reviews the article “Design of Randomized Controlled Trials” Kenneth Stanley which has been published in the Circulation, Journal of American Heart Association.
Initially this review will summarize about the article. Secondly it will briefly analyze the article’s structure, content and its validity, then it will examine how the provided information is formed and whether the reader could comfortably access it .Then, the review will criticize the article, estimating its authority, currency, accuracy, objectivity and coverage. The review will also analyze the graphs and tables prior to judge the article’s accessibility and credibility as a final. The article was very well written and sound conclusively.
Review of Literature:
The main purpose of the article is to check out the various designs of Randomized clinical trials which are considered as Gold standard of clinical trials and its effective implementation in clinical studies.
This article clearly mentioned about the uniqueness of Randomized clinical trials and its association with Phase 3 clinical trials. This article discussed about the equipoise which is one of the ethical concept in clinical trial design and conduct. It highlighted the limitations and practical problems of equipoise in somewhere.
It also looked in to the various classifications and designs involved in phase 3 clinical trials.
It deeply insisted about the bias involved during randomization and it showed the solution to alleviate those problems.
From this article, even the basic researchers could able to understand the importance of Randomized clinical trials a...
... middle of paper ...
...lved in Randomized Clinical Trial.
In mean time, this article highlighted some points about statistical power and the importance of null hypothesis in brief.
Conclusion:
This review summarized and critically reviewed the article “Design of Randomized Controlled Trials” Kenneth Stanley.
The content, structure, strengths and limitations of the article were analyzed and critiqued. The article not only mentioned about the importance of essential design, randomization and statistical power. It also insisted the importance of timely recruitment of patients in Randomized clinical trials.
Overall this article revealed each part of Randomized Clinical Trails including designs, Randomization, Enrollment and quality of the study.
As the research world is always seeking bias free environment in research studies, this article is informative and innovative to follow.
This systematic review conducted by Takeda A, Taylor SJC, Taylor RS, Khan F, Krum H, Underwood M, (2012) sourced twenty-five trials, and the overall number of people of the collective trials included was 5,942. Interventions were classified and assessed using the following headings.-
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
...s little information about the possible benefits of the study or the side effects. The side effects proved to be significant (gastrointestinal complains, headache, and an elevation of alanine aminotransferase), while the benefits were minimal. This situation emphasizes the need for a balanced approach when it comes to drug clinical trials.
The pretest-posttest design, crossover design, placebo, quasi-experiments (lack randomization but involve intervention and is usually found to be more acceptable to a broader group of people who are not always willing to be randomized in clinical trials). The RCT study known as the “gold standard” (for interventional studies, controlled and randomized for comparing a controlled and interventional group variable) and The Cohort (prospective) design research (analysis or the observational design with cohort, it starts with a recognized cause and then goes forward to the recognized effect). The clarification of the outcomes of the statistical analysis in quantitative research, understanding the research practice and the identification of the basis of evidence-based practice contained by the sections of research and critiques of that research. By graining an understanding of these steps and knowing how to rethink research and revise my views of the research will aid in success of my practicing these tactics (Polit, & Beck,
West, S. L., & O'Neal, K. K. (2004). Project D.A.R.E. outcome effectiveness revisited. American Journal of Public Health. doi:10.2105/AJPH.94.6.1027
Torgerson, D. J. (2003). Avoiding Bias in Randomised Controlled Trials in Educational Research. British Journal of Educational Studies, 51(1), 36-45.
Overall, the researchers reasonably handle, carried out and contextualize the whole procedure of the operational phases of the study process with clarity and rationality. As I get ready and thoroughly consider for my future research, this study has provided me with a glance of the vital things that I must incorporate in my trialing.
EBPP “is the integration of the best available research with clinical expertise in the context of patient characteristics, culture, and preferences” (book essay 1). The first major facet of EBPP is the use of the best available research. Opponents have argued that randomized clinical trials are too narrow a type of study for psychology. A very valid point, this had been addressed in the new EBPP standard. Multiple types of research are included, ranging from public health and ethnographic research, to systematic case studies, to qualitative research, to meta-analyses (book 1). Using research-backed treatments cuts down on bias in treatment. Some psychologists argue that their experience is enough to know what works (Kendall 1998). Unfortunately, a human can be biased on incorrect without any knowledge of it. Data-backed tre...
It is essential that when using evidence-based practice guidelines to choose a treatment, that variety of research methods are applied so that the best relevant data can be produced. Such methods include qualitative/quantitative research, randomised controlled trials and systematic reviews. Both qualitative and quantative methods produce valuable data. Quantative research produces numeric evidence that is necessary for practice and can be measured and qualitative research produces descriptive data about the subject by using patients views etc. which can also be applied to clinical practice (Broeder et al, 2010)
O'Brien (2013) defines RCT as a research technique that has been through the ages. It first was applied in medical studies. Today, it is a quantitative method widely used in clinical trials where participants answer or confirm a research question. Clinical trials that are designed with RCT in a medical context focus on prioritizing the protecting of human participants with the aid of ethical criteria; however, at the discretion of the researcher (O'Brien, 2013).
Sackett, D.L et al. (1996). Evidence based medicine: what it is and what it isn't. British Medical Journal, 312: 71.
Tunis S., Stryer D., Clancy C. Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy. JAMA. 2003;290(12): 1624-1632
Clinical trial is a gateway to become proved practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials require that prospective, carefully selected subjects and endpoints, a control group, randomly allocated subjects into a treatment group and a control group, blinded both subject groups and investigators, sufficient sample size, and an approved independent ethics committee and monitoring by data safety and monitor board to have stronger the scientific validity on the clinical trials (Brody, 1997). The use of placebos will enable to have more scientifically reliable outcome. However, unnecessarily or ineffectiveness of placebo use is also claimed therefore considering appropriate conditions and suitable cases would be needed for placebo use.
Researchers work hard to eliminate bias from outcomes through approaches that diminish subjectivity and modification from unknown sources. Randomization, use of well-matched controls, and blinding of analysts and researchers are some ways to try to a...
The outcome of each trial was standardized to an odd’s ratio; a odd’s ratio below 1.0 indicated a beneficial effect. The qualities of the trials were assessed by thee factors: randomisation, masking and data analysis. The information abo...