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- Afzal Hussain
Problem and Purpose
In this paper, I will be critically analyzing the article “A Randomized Trial of the Effect Of Community Pharmacist and Nurse Care on Improving Blood Pressure Management in Patients With Diabetes Mellitus- Study of Cardiovascular Risk Intervention by Pharmacists–Hypertension (SCRIP-HTN) by Donna L. Maclean ; Finlay A. McAlister; Jeffery A. Johnson, Kathryn M. King; Mark J. Makowsky ; Charlotte A. Jones and Ross T. Tsuyuki. This article outlines a quantitative experimental design involving two sample groups (experimental and Control). According to Sullivan-Bolyai, Bova, & Singh (2013), experimental designs are particularly suitable for testing cause and effect relationships because they help eliminate potential alternative explanation (threats to validity) for the findings (p. 217). The authors articulate their recognition of the fact that interventions are key markers to identify and observe blood pressure (BP) control in diabetic patients.
The authors also recognize the fact that there is a need for a new model of care to improve BP control, particularly with significant challenges in accessing primary care physicians attributing to labor shortages in the health scare system. In addition, the authors used manipulation by introducing the intervention, then by comparing the standard and usual care among the control group and experimental groups. This resulted in the manipulation variable being the difference of care among patients with blood pressure and diabetes. One intervention delivered to the group based on the manipulated variable of difference of care is evident through the interventions made by the pharmacist-nurse teams at various pharmacy sites, which included cardiovascular risk reduction counselling, education brochure on hypertension, lifestyle strategies, effect of diabetes on high BP, and referral to the patient’s primary care physician for further BP and cardiovascular assessment (McLean, McAlister, Johnson, King, Makowsky, Jones, and Tsuyuki, 2008, p. 2356).
The control group received the standard and usual treatment compared to the experimental intervention group. Furthermore, blood pressure wallet card, educational pamphlet on diabetes and physician care were received by the control group. (McLean et al., 2008, p. 2355).The authors used randomization to categorize the research participants into two groups- experimental intervention and control which is set to receive the standard treatment of care. Mclean et al (2008) states, “ Randomization was at the level of the patient ( stratified by pharmacy and using a variable block design), it was performed centrally to preserve allocation concealment using a computer generated sequence over a secure internet service at the Epidemiology Coordinating and Research (EPICORE) centre,(p. 2356). The authors propose a practical necessity for this research problem to be explored and be further researched.
The purpose of the research was to explore whether pharmacist or nurses can professionally contribute to improving the BP control of patients with diabetes and implement preventative care measures due to ongoing lack of physicians, pharmacist and nurses, it is clear that the research is also significant. It is based on changing the attitude of health care professionals to meet current outcomes, outcomes which seem to be on par with those of the current health care system in Canada.
Sample Size, Design and Collection Methods
The sample for this study was appropriately assembled for a quantitative study. The study sample is easily identified when reading the article, included a description of the demographic characteristics and the size of the sample. Also included were any sampling bias, drop outs or loss of patients to follow up. In doing so, an adjustment of 85 to 110 per group were added. (McLean et al., 2008, p. 2357). Its purpose was to test the efficacy of community-based interventions through a pharmacist and nurse team approach on reduction of cardiovascular events in diabetes mellitus patients. This was achieved by measuring the BP which has been linked to comorbidities such as cardiovascular disease, and to BP measurement changes used as an indicator of health. This sampling was appropriate to the study as the sample were to represent diabetic patients. Mclean et al (2013) states, “ All adult diabetic patients with BP higher than 130/80 mm Hg on 2 screening visits separated by 2 weeks were identified in participating pharmacies. Diabetes was identified by community pharmacists through the use of diabetes indicator medications in each pharmacy’s prescription database. (p. 2356).
In this study, Mclean et al (2008) used a randomized controlled trial (RCT) in 14 community Pharmacies in Edmonton, Alberta as a method of data collection (McLean et al., 2008, p. 2355). Participants were identified and manipulated by pharmacists and nurses who were trained using a combination of an online learning program and a case-based learning session – both based on the Canadian Hypertension Education Program (CHEP) guidelines”. Also the use of a commercial BP monitor set at an average of 5 measurements of BP taken 1 minute was used to measure participants BP (McLean et al., 2008, p. 2356). Data analysis procedures were appropriate to the research study because “all analyses were conducted using a commercially available software program” (McLean et al., 2008, p. 2357).
Threats to Internal and External Validity specifically the authors use of instrumentation and selection could possibly have introduced problems of internal validity in the research. This threat was discussed by ensuring that both groups (control and experimental) BP were measured with the same BP device, which has 6 readings, discard the first test and further takes an additional 5 measures . Mclean et al (2008) found that, “It is possible that the more frequent contact with the pharmacist –nurse team reduced the anxiety of patients and any “white coat effect” on their BP measurement”. (p.2359). Furthermore, the screening modules used by the researchers to collect the data were conducted by pharmacists and nurses well versed in their profession. Selection bias was another threat predisposing the sampling design to internal validity.
The authors in their findings found that patients eligible for selection presented with lower BP, this can be caused by the researchers utilizing a convenience sample instead of a random sample. Also, selection bias may have been an essential part of the end results due to the fact that patients who are eager to monitor and control their BP are more likely to agree to participate in the trial, also that more than 80% of trial participants were aware that hypertension is a risk factor for cardiovascular disease (McLean et al., 2008, p. 2358). The external validity of the study was weakened by the sampling design. The authors failed to take into consideration non English speaking people, whose cultural differences and beliefs could influence the study, and who may lack health literacy to read and identify medical abbreviations and symbols. Maclean et al (2008) states, “pharmacists and nurses who participated may be different from those who did not participate, an investigator volunteer bias that may limit generalizability of the program” (McLean et al., 2008, p. 2359).
Limitations of the Design
One major limitation of the design identified by the authors is regarding the interventions implemented in regards to the in person contact time between patients and the pharmacist-nurse team, which can be further be evaluated by future studies on whether less intensive interventions are The researchers identified a potential limitation regarding that the intervention involved substantial in-person contact time between patients and study personnel, and that future studies will need to determine whether less intensive interventions are productive in controlling BP in diabetic patients (McLean et al., 2008, p. 2359
Generalization of Findings The research findings can be generally be applied to larger populations, the authors acknowledge the fact that their research intervention was extremely efficacious, resulting in a 24.1 mm Hg greater reduction in systolic BP (McLean et al., 2008, p. 2358) They recommend a new model of care to improve BP control. In addition, by utilizing an experimental research design in which a cause and effect relationship can be analyzed and measured, the researchers were able to provide coherent evidence and correlation that community pharmacists and nurses through a collaborative effort with primary care physicians could have a huge impact on hypertension management in patients with diabetes mellitus and BP control within the community (McLean et al., 2008, p. 2360)
LoBiondo-Wood, G., & Singh, M.D., (2013). Introduction to quantitative research. In C. Cameron, & M. D. Singh (Eds.), Nursing research in Canada: Methods and critical appraisal for evidence-based practice (3rd ed.) (pp. 198-215). Toronto: Elsevier Canada McLean, D. L., McAlister, F. A., Johnson, J.A., King, K.M., Makowsky, M.J., Jones, C.A., & Tsuyuki, R.T. (2008). A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus. Archives of Internal Medicine, 168(21), 2355-2361 Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/19029501
Sullivan-Bolyai, S., Bova, C., & Singh, M.D. (2013). Experimental and quasiexperimental designs. In C. Cameron, & M. D. Singh (Eds.), Nursing research in Canada: Methods and critical appraisal for evidence-based practice (3rd ed.) (pp. 216-233). Toronto: Elsevier Canada
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