Student Nurse Critical Review of Literature

A power analysis indicated the need for 40 subjects per group in order to provide 80% power so that it can well detect differences between the two groups. These differences were detected by using a

One example of such study is REMOTE, which is being carried by Pfizer. The FDA approved the study for testing a drug using mobile phone and the Internet technology. The Internet technology was used to facilitate the recruitment of patients and study the efficacy of the new method for conducting clinical trials. It was a phase four study evaluating the results of the tolterodine extended (ER) release 4mg for overactive bladder. The idea behind the study was to replicate the results of the previous trials of tolterodine ER done through conventional means and compare it to study done by web-based system. The procedure of consenting, recruitment of patients, and checking the eligibility was done through web- based questionnaires. After patients had their lab samples tested in the community, they were enrolled in the run-in phase where they were requires to fill in bladder e-diaries. The study medication was shipped directly to the patients (Orri et al,

Placebos have been used in clinical trials since the eighteenth century but did not become a research topic until the late twentieth century (van Haselen, 2013). Most often when using placebos in clinical trials it is to determine whether or not the active agent has more effect on a patient than the placebo by providing each to the same number of recipients. The trials are almost always double blinded, this means that both person giving the drug and the person receiving it are unaware whether or not it is active so that good care and relationships must be present in the recipients at all times (Tavel, 2014). Ovosi, Ibrahim, & Bello-Ovosi (2017) declared “The choice between placebo and active controls in clinical trials affects the quality of the result as well as the ethical and scientific acceptability by both the public and regulatory bodies. It has, therefore, continued to generate discuss among researchers” (para. 3). This goes against the autonomy of a patient which is the right for a person to

Evidence based practice, “involves integrating the best available research evidence with professional expertise while also taking account of patient preferences the patients state setting and circumstance and health care resources” (Gerrish, K. Lathlean, J, 2015). As the health care profession constantly changes, then it is vital that all evidence based practice is kept up to date with current information and research, relating to nursing practice. Always assuring that the patients need are taken into consideration (Sackett et al, 1996).

Clinical trials, or a test before a treatment is approved to be safe for human consumption, have been dated back to the biblical times. Recorded in the “Book of Daniel” a king and military leader performed the first known clinical trial (Evolution of Clinical Research). Although his experiment was nowhere near what we conduct in today's society scientist, doctors, and other researchers before them have learned through trial and error, and they have used clinical trials to study diseases. In 1774 James Lind followed through with the first clinical trial of the modern era studying scurvy.

Interestingly, IRBs are set up mainly to confirm that a clinical trial is ethical and that the process will not harm patients. Whether or not the clinical trial is constructed properly or not is commented upon, but may not be a major focus of the review. For this reason, many institutions also require a concurrent review by an institutional “Office of Clinical Research” and a regular meeting of supervising clinicians during the

The process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

Evidence based practice and practice based evidence are a big part of a treatment process. These two can provide appropriate treatment that is needed to make advances in health care practices. Having enough evidence helps people determine whether to do something or not. To provide the best possible treatment for each patient you have to take information and see what will work best for each of your patients. Some will work and some will not work. Methodological issues can arise with in any type of research and some are more controversial than others. In the article “Practice Based Evidence: Back to the Future” (2011) the point of view was that research comes from evidence and that

Evidence based practice has a great impact on health care system, nursing practice, teaching, and science. The necessity for evidence based quality enhancement and healthcare alteration underscores the requirement for redesigning and implementing care that is effectual, secure and competent (Stevens, K., Ma., 2013). The movement of evidence based practice commenced with the identification of the problems faced in healthcare system. The unacceptable gap between what we know and what we do in the patients care(Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. 2001). The main intend of evidence based practice in health care is to provide the resources by which the most latest relevant evidence from research and studies can be judiciously

“Evidence-based practice (EBP) is an approach to health care wherein health professionals use the best evidence possible, i.e., the most appropriate information available, to make clinical decisions for individual patients” (McKibbon, 1998). It is patient/family centered and involves complex and contentious decision making that is based on evidence available as well as the patient situations, characteristics and preferences. The evidence found does not make the decision, but helps support the patient care process. Health care is ever changing and involves multiple different aspects that evidence based practice gives the health care providers the formalization of the care process. There are

The use of this systematic approach allows the reader to quickly discard papers which do not meet inclusion criteria.

But, this is proven wrong because many studies do not consist of any long or hard tasks. According to the National Library of Medicine, a majority of trials require “minimal amounts of time and effort” (“Clinical Research”). One example of a research procedure is shown by Bridge, “right handed males aged 18 to 40 take part in a trial on the pain killing effects of Botox, which involves two outpatient visits.” This case presents the low complexity of a trial; in this circumstance only two visits are needed. Also, the only qualifications needed to participate in this case include: being a middle-aged, right-handed male.

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

This measure is a reliable indicator of trial quality and is based on each trial’s reporting and quality of randomisation and blinding attribution (CASP 2006).

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.