Randomized Controlled Trial of a Nurse-Led Rheumatology Clinic for Monitoring Biological Therapy - Essay Example

Critique of a Research Paper Introduction This is a critical analysis of a research study; “Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy”, by Larsson, and his colleagues. The analysis is done using a Critical Appraisal Skills Program tool for randomized clinical trials. The framework has three main areas of focus; the research results validity, their effect and precision, and their application. This is achieved through 11 questions which help make sense of the clinical trial (CASP International Network, 2012). ARE THE RESULTS OF THE REVIEW VALID? Did the trial address a clearly focused issue? Yes, the trial addressed a clearly focused issue. A clearly focused issue is similar to the research problem. Identifying a research problem is not always easy since every problem has compounding factors. Researchers, therefore, have to be keen when giving the exact problem being studied. This is why the researchers need a clear focus; a well-defined research question which can guide the research study. The clear focus eliminates frustration, confusion, wastage, and saves time (Blessing & Forister, 2013). In the report, a clear focus that would guide the research would be; “are nurse-led rheumatology clinics qualified for providing the same services offered by rheumatologist-led clinics?” The report is on a “Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy” (Larsson et al., 2013, p. 164). The aim is to judge the nurse-led rheumatology clinic against rheumatologist-led clinic, in monitoring of biological therapy. It has focused on patients in remission or those with low disease activity, and are undergoing biological therapy. The main issue is that, there are nurse-led clinics that have previously been successful. In the UK, for example, some rheumatology nurse-led clinics showed a high level of effectiveness. It is due to such results that the researchers came up with the thought of a nurse-led intervention in Sweden. In Sweden, it is the rheumatologists who manage such clinics. Larsson and others assumed that there would be no significant differences in treatment consequences between the two interventions. . The results would provide evidence for practice and encourage the creation of nurse-led rheumatology clinics for the management of patients with stable chronic inflammatory arthritis, who are undergoing biological therapy. A clearly focused issue here is whether the nurse-led rheumatology clinics are suitable and qualified to manage patients. Was the assignment of patients to treatments randomized? Randomized controlled trials are studies that make use of random assignment of study subjects to treatment options being studied. The study subjects are to receive of not to receive health care service intervention, after which a follow-up is done to determine the effect of the intervention. Random allocation ensures that known and unrecognized confusing factors are evenly distributed between treatment groups (Patil, 2008). Randomized controlled trials are normally used to assess the effectiveness, quality, and cost of health care services. In the research paper under analysis, for example, the RCT has been used to assess the effectiveness of an intervention: nurse-led rheumatology intervention. RCTs are considered the most reliable sources of evidence for practice in the medical and health care fields. This is because of their ability to eliminate biases and false casualty (DiCenso, Guyatt & Ciliska, 2005). A randomized controlled trial has the following characteristics. Random allocation of study subjects to intervention groups. Identical treatment to all intervention groups except for the experiment. Study subjects and investigators are kept on the dark about which interventions are used until the end of the study (Patil, 2008). Larsson and others’ research had two interventions, the rheumatologist-led and the nurse-led. The study was carried out in a rheumatology clinic in Sweden, and there were two rheumatologists visiting annually. The study replaced one rheumatologist visit by a nurse led rheumatologist monitoring visit. There were 600 patients undergoing biological therapy, but the researchers only selected those who had peripheral arthritis. Those who experienced adverse events or recurrent infections due to the treatment were excluded. There were 107 patients who agreed to participate in the study. They were randomly assigned to the nurse-led rheumatology clinic or the rheumatologist-led clinic. This was done through the random picking of envelopes assigned to either of the intervention groups. These envelopes had assignments to either of the intervention groups; they were mixed, and each patient allowed to select one. There was a follow up on the sixth and 12th months of the study. Considering the characteristics of an RCT mentioned above, Larsson and others’ research randomized the treatment of the patients. The selection was random, and they had a follow-up on the intervention effects. Randomization also considers the intention of the trial, as well. Larsson’ randomized clinical trial was aimed at finding out the effectiveness of alternative intervention, just like RCTs are meant to determine the effectiveness of interventions or treatments. The clinical trial here is of the effectiveness of nurse-led rheumatology clinic. The study also provides reliable evidence in nursing practice. Were all the Patients who entered a trial properly accounted for at its conclusion? Accounting for study subjects contributes to the validity of research. Some research subjects may die, and this could be due to the treatments administered or not. It is important to indicate the cause of death. If there are dropouts, it is also important to include this in the report and indicate the reasons for drop out. Such information is used to improve clinical research and also provide proof of the effectiveness of the interventions (Mesbah, Cole & Lee, 2002; Chow & Liu, 2013). In Larsson and others’ research, all study subjects have well been accounted for. There were 107 patients at the beginning of the study. Four dropped out after six months; one from the rheumatologist-led group and the other three from the nurse-led rheumatology clinic group. Six more patients had dropped out at the end of the 12th month follow up; three from each side. The reason for the patients’ drop out was, however, not indicated. The patients were analyzed in their respective groups; that is, the rheumatologist-led clinic group, and the nurse-led rheumatology group. Were patients, health workers and study personnel ‘blind’ to treatment? Being blind to the treatment of intervention is necessary to eliminate biases and false casualties. It improves the reliability of study results. Being blind to treatment is a randomized clinical trial characteristic where patients, health workers, and study personnel are not told about specific treatments or interventions given to the study subjects until the end of the study (Schulz & Grimes, 2002). In the research, it is not indicated nor is t clear whether the patients, the researchers, and the health workers were blinded to the interventions. Were the groups similar at the start of the trial? Group similarity in a randomized clinical trial is also important for the reliability of the research results. Any differences can confuse the results, for example, an elderly patient with the same disease as a group of young people can exhibit different symptoms. These can be analyzed in the last stage as the outcomes of an intervention or treatment. Such an analysis does not produce reliable results (EMEA, 2006). This is why it is important to have the groups similar. They should not only have similarities at the baseline, but should also be treated and observed in a similar manner during the trial. The only difference should be the test and the control drug. The reason for similarities between the groups should consider the purpose of the control group. Control groups are meant to show the difference between the patient outcomes when the test is used. They allow discrimination in changes in signs, symptoms and other morbidity, that may be caused by the test treatment. Other differences can, therefore, produce these changes, affecting the study results. If the groups are not similar, the effectiveness of the treatment or intervention being studied is affected. In the research study, the groups selected are similar on the disease basis, and this is the most important requirement in this intervention. The patients all belonged to a rheumatologist-led clinic before being separated to investigate the effects of a different clinic. This is similar to Dose-response concurrent control where the control is the same patient, but treatment is based on the change of dose. In this case, the change is on the type of intervention from rheumatologist-led to nurse-led. One rheumatologist’s visit was replaced b a nurse-led rheumatology intervention. The research report indicates that the patients who participated were older, but had no significant differences in clinical and demographic characteristics. Aside from the experimental intervention were the groups treated equally? Equal treatment is a component of the research design meant to seal the treatment options so that the patients do not recognize any difference in treatment and drop out the study. Equal treatment is necessary for the researcher to attain reliable results. In the research report, the patients were treated equally except for the difference in the interventions. In the nurse-led case, patient care is person-centered. This offers the patient the freedom to talk about their illness and the biological therapy. In both interventions, the rheumatologist and the rheumatology nurse checked "tender and swollen and joints based on a 28-joint count when assessing the disease activity, and they both evaluated the results of the laboratory tests " (Larsson et al, 2013, p. 167). Yes, the groups were treated equally. WHAT ARE THE RESULTS? How large was the Treatment Effect? The effect of an intervention or treatment depends on the breadth of issues that it addresses. Most of the research outcomes touch all aspects of health care delivery, that is, from the clinical issue itself to healthcare organization, regulation, and financing (Foundation for Health Services Research, 2003). In the research report, the effect of the intervention is vast. It affects the organization of health care in relation to rheumatology department; it affects financing of that section if nurse-led rheumatology clinics will be allowed, and it affects the management of the disease. How precise was the estimate of the treatment effect? High precision is associated with high standards and reliability of a research finding, especially in clinical trials. These trials are focused on finding out the effectiveness of an intervention or a treatment, and so the higher the precision in showing the results, the higher the confidence in such a research gets (Kothari, 2004). In Larsson and other’s research, it is reported that, “there were no statistically significant differences in changes in the DAS28 (P = 0.66) or DAS28-CRP (P = 0.70) between the intervention and control Group” (Larsson et al., 2013, p. 169). This shows the level of precision in distinguishing the two interventions. WILL THE RESULTS HELP LOCALLY? Can the results be applied in your context? Or to the Local Population? Medical and scientific research are usually carried out to provide evidence to practitioners, policy makers and even patients, to improved health care (Selby & Autier, 2011).The same way the results of this research can be applied in Sweden or, even in areas with patients with rheumatoid arthritis. Yes, the results can be applied in Sweden, which is where the research study was carried out. Sweden already has rheumatologist-led clinics, caring for patients with related diseases, but nurse-led clinics can be used to help reduce the number of patients that the rheumatologist has to cover, and help increase the quality of care in rheumatology patients. Were all clinically important outcomes considered? Clinical important outcomes are hose that would catch the attention of the patient, and make a difference in clinical management (ASRM Practice Committee, 2008). The research focused on one clinical variable, that is, the disease activity which is the most important measure of rheumatoid disease. This is what was reported on. There were no side-effects mentioned or related clinical effects of the intervention. So, yes, all clinically important outcomes were considered. Are the benefits worth the harms, and costs? Yes, they are. This is because the nurse-led intervention provides a person-centered approach to treatment that complements the rheumatologist-led clinic. It is one way of accomplishing the European League Against Rheumatism recommendations concerning management of chronic inflammatory arthritis, and it can be implemented for use by a broader patient population, and not just to rheumatoid patients only. Conclusion The above critical analysis was based on three main areas; that is to determine if the results are valid, to evaluate the results, and to find out if the results can help locally. Larsson and others’ research study is valid, has high precision results, and impacts a large and diverse area of health care management and the results can be applied in Sweden, as well, as in other countries. According to CASPS tool of analysis, a randomized control trial, this research study meets all the requirements. References ASRM Practice Committee, 2008, Interpretation of Clinical Trial Results. Fertility and Sterility, 90(3): 114-120. Blessing, D. J., and Forister, J. G., 2013, Introduction to Research and Medical Literature for Health Professionals, Burlington, MA: Jones & Bartlett Publishers. CASP International Network, 2012, 11 questions to help you make sense of a trial. Retrieved from: http://www.caspinternational.org/mod_product/uploads/CASP%20Randomised%20Controlled%20Trial%20Checklist%2031.05.13.pdf Chow, S., and Liu, J., 2013, Design and Analysis of Clinical Trials: Concepts and Methodologies, 3rd Ed., New York: John Wiley & Sons. DiCenso, A., Guyatt, G., and Ciliska, D., 2005, Evidence-based Nursing: A Guide to Clinical Practice, Mosby: Elsevier Health Sciences. EMEA, 2006, Choice of Control Group in Clinical Trials. Retrieved from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf Foundation for Health Services Research, 2003, Health Outcomes Research: A Primer. Retrieved from: http://www.academyhealth.org/files/publications/healthoutcomes.pdf Kothari, C. R., 2004, Research Methodology: Methods and Techniques, New Delhi: New Age International. Larsson, I., Fridlund, B., Arvidsson, B., Teleman, A. and Bergman, S., 2013, Randomized Controlled Trial Of A Nurse-Led Rheumatology Clinic For Monitoring Biological Therapy, Journal of Advanced Nursing 70(1), 164–175. Mesbah, M., Cole, B. F., and Lee, M. T., 2002, Statistical Methods for Quality of Life Studies: Design, Measurements and Analysis, New York: Springer. Patil, K. S., 2008, Challenges in Subject Recruitment and Retention in a Randomized Controlled Trial, Ann Arbor, MI: ProQuest. Selby, P. and Autier, P., 2011, The Impact Of The Process Of Clinical Research On Health Service Outcomes, Annals of Oncology, 22(7): vii5-vii9. Schulz, K. F., and Grimes, D. A., 2002, Blinding In Randomised Trials: Hiding Who Got What, THE LANCET, 359: 696-700. http://apps.who.int/rhl/LANCET_696-700.pdf. Read More