Introduction
The present discussion critiques Goodman et al (2008) randomized control trial involving 188 participants. The study was meant to investigate the impacts of a nurse-led program for supporting and managing the lifestyle of patients who await cardiac surgery. The authors based the study on researches that were conducted earlier. The previous studies suggested that there was an improvement in risk factors that contributed to coronary diseases while the patients waited for cardiac surgery to be performed. Three premises were considered as the base for carrying out the study. First, the time taken while a patient waited for surgery was stressful to the patient. Secondly, patients need and appreciate any support that is provided during this time. The third premise was based on the fact that a cardiac rehabilitation program should be offered to all patients who are due to undergo CABG surgery as recommended by international guidelines. The study was carried out when the waiting time for CABG surgery in the United Kingdom was estimated to be nine months. The authors argued that this time was adequate to learn the anxiety in the patients and emphasize the need for cardiac rehabilitation. Consequently, this time was adequate to encourage the patient to become ready for exercise that would later change their lifestyle in the future.
The authors based the study on a randomized study that was carried out in Scotland on 98 patients. In this previous research, the program was tried by the nurses sharing the roles in the support program. The community nurses and the hospital provided the risk factor to be assessed and support to changes in lifestyle; on the other hand, patients waited for surgery for 8.4 months. However, the current research made several improvements for all the risk factors as opposed to the control group. For instance, Goodman et al (2008) noted that “however the estimates of the effect size had wide confidence intervals and the randomization process was unusual in that the patients were allocated to their group before recruitment” (p. 192). Goodman et al used this study to influence a way of creating a nurse-led program for the education and support of patients to help reduce risk factors and also improve the fitness of the patient. The patients were provided with a local manual which provided an overview of the heart diseases and the risk factors. This paper will first summarize the methods used and findings of Goodman et al study, including the outcomes of the intervention and the validity of the results. The current paper will then move to a critical appraisal of the study. This will involve considering initial information about the participants as well as data from throughout the study; it will also address the intervention and results. Finally, the value of the article critiqued will be assessed.
Summary of the study
Methods
A pilot study of 40 patients was first conducted. Statistical and clinical changes in coronary factors like blood pressure and glucose demonstrated a significant change. Despite the sample size of the pilot study being small, the systolic blood pressure dropped from 57% to 38% while the prevalence of blood glucose dropped to 3% from 17%. This program needed a high amount of labor and also the patients felt that there was no need for repeated visits since they felt that the risks factors were under control. As a result of this, patients instead valued the first visit. The pilot study was later developed into a randomized trial of an appropriate size that would assess what would result from nurse-delivered lifestyle support. The study was designed to administer a randomized controlled trial (RCT). A qualitative approach was adopted to determine the perspectives of the nurses and the patients regarding the impact of support for patients before undergoing cardiac surgery. Semi-structured interviews and focus group discussions were the research tools used in the research. Goodman et al (2008) noted that “costs of all in-patient, outpatient and community contacts, and the home care contacts were analyzed to look for any impact on costs and health care utilization” (p. 193).
During the randomized control trial, the study adopted the hypothesis that there was reduced anxiety and controlled risk factors in patients who received a nurse-led support and education program before undergoing CABG surgery. The risks factors were the ones resulting from post-operative complications as a result of coronary heart disease progression. This was low as compared with patients in the control group who were not provided with such routine care.
Every month, the pre-operative assessment was carried out on patients by the cardiac home care nurse to the intervention group. This assessment targeted the kind of questions that would be asked by the patients and also tried to convince the patients to undergo a cardiac assessment to help the patients make lifestyle changes. An example of such a question was the one regarding the patients’ individual needs during the operation and how to deal with anxiety. The assessment also addressed requests made by the patients on counseling so that the patients would make lifestyle changes. This was considered an important exercise as it would help them to respond to risk factors. The manual provided to the patients during the pilot study contained the risk factors, information regarding how to prepare for surgery, and how to respond to cases of chest pains. The homecare nurses guided the patients in the intervention group to understand the manual (Goodman et al, 2008).
On the other hand, patients in the control group were given adequate care. Goodman et al (2008) noted that “this care consisted of the hospital helpline telephone numbers and a pre-surgery information day in addition to baseline information”. This was opposed to a similar study conducted in London which halted as a result of several medical problems experienced in the control group. The likelihood of similar medical problems prompted the need for baseline visits in the control group. Research assistants visited patients in the control group at their homes to take measurements. The research assistants comprised a team of independent staff. Patients’ blood samples were taken and questionnaires administered, the results were later sent to the intervention group using pre-paid envelopes. Following up on the patients went on until three months after the patients’ discharge from the hospital. The sample size for the study was 200 patients (100 for each group).
Findings
It was found that there was no significant difference between the two groups in any of the variables considered as the baseline clinical variables. Five and half months was identified as the median waiting time for the experimental group while for the control group, the median wait time was 5.4 months. According to the study, the primary outcome measures indicated that the risk factors reduced; but a little difference between both the intervention and the control groups was noted as shown in the table below:
The statistical analysis of blood pressure and cholesterol indicated an improvement from the baseline surgery. On the other hand, small levels of HAD were recorded in patients of the intervention group. However, for the two groups, the median stay time did not indicate any statistical difference. As noted by Goodman et al (2008) “the number of smokers was too small for analyses to be meaningful and the change in glucose levels was not significant at any measurement point”. The study also found out that intervention on quality of life did not have any evidence (Goodman et al, 2008). The evidence on the quality of life would be realized after multiple testing. As noted by Goodman et al (2008) “for the quality of life measures within the groups, there was no difference apart from the SF-36 composite physical health score, which reflects the same pattern in the between-group analysis”.
Critical Appraisal
The randomization of patients in all studies implies that the intervention and control groups are balanced in all respects except that the intervention group receives the intervention (Polit & Beck, 2008). On the contrary, in the current study, both the control and the intervention group were randomized. In the current study, the researchers left the allocation of the participants into the groups to the home care nurses, who provided support to the patients at their own homes. Additionally, the home care nurses were not aware of whether the rooms in the surgery unit to which they assigned the patients had been designed for controlled or experimental groups. Thus, it looks like that the allocations of the groups led to randomization of patients that was furthermore concealed.
On the other hand, during the randomization of the groups, the numbers of participants per group were one hundred for each group; this does not normally happen (Polit & Beck, 2008). Goodman et al (2008) did not provide adequate details concerning this issue. Despite these issues, from the information provided, both groups were shown to show very small differences in all the outcomes; thus, there was no need to adjust the analyses for the groups. These results presented some lack of proper understanding; this was because there was a need to explore the future when making such an observation since the results could have been as a result of the patients being interviewed by the homecare team rather than them agreeing to go to the hospital. This was evidenced by the evaluation made on the heart manual which indicated that there was less use of GP and hospital services, such an evaluation could be considered as having emerged from the patients receiving care from the nurses while still in their own homes.
It was further noted that no participants in either group were aware of the group allocation. The strength of any study in terms of allocation of the participants can be measured by the blinding of the patients in terms of knowledge of the assigned groups (DiCenso, Guyatt & Ciliska, 2005). In the critiqued article, allocating patients was left to home care nurses, who are not part of the treatment group during the patient’s stay in hospital (DiCenso, Guyatt & Ciliska, 2005). The patients themselves were not sure whether they received the intervention or not when they were guided on the risks factors resulting from cardiac surgery. Patients may have assumed that the manual was placed in their rooms as part of the hospital facilities provided to patients, although some may have believed this to be the intervention. Patients may respond differently if they believe they are receiving an intervention treatment.
Further, the home care nurses in the study were aware of the participant’s group allocation (Polit & Beck, 2008). Based on the information provided, the home care nurses could realize that rooms with telephone helpline service are the intervention group’s rooms. In nursing intervention studies, it is difficult to blind nurses in many studies (DiCenso, Guyatt & Ciliska, 2005). Moreover, home care nurses and researchers were involved in assessing the outcomes. Nurses and researchers were aware of participants’ group allocation, whereas the researchers measuring and recording blood pressure and cholesterol levels were blinded. Clinical staff members’ knowledge of the groups may have resulted in them unintentionally affecting the outcomes of the study; however, any such effects are likely insignificant due to the nature of the study. The current study was therefore an improvement of the earlier study and had therefore adopted new methods of solving problems which included telephone helpline and pre-operative seminars and clinics. This kind of support was therefore really adequate thus nullifying the need for home care visits.
The delivery of the intervention to the experimental group was consistently carried out with follow-ups. By incorporating manuals to each patient of the intervention group participants, researchers could deliver support directly when participants were in their homes. Involving the nurses in guiding the patients to understand the risk facts was a good strategy to make the patients understand the risk factors. It seems that the researchers educated nurses the patients on how to avoid the risks factors that might result in cardiac surgery, but this information is not mentioned in the details.
The measurement instruments used appeared to measure what they were supposed to be measuring; in other words, the results appear valid. Measuring the systolic blood pressure as an intervention was found significant in both the primary and secondary outcomes. The researchers provided the data, including the mean and standard deviation, to demonstrate the significant differences between the intervention and the control group. In studies of nursing interventions, researchers usually express their results using the mean to show differences in variables (Cullum et al, 2008). The measurement instruments provided records that did not differ so much; as a result of these figures, it was difficult to notice the difference in variables between the two groups.
The study conducted by Goodman et al (2008) required patients who had nine months to prepare for cardiac surgery. The results of the study can be employed in the United Kingdom where most papers experience heart problems. The patients can be in a better position to avoid anxiety and risk factors that are associated with patients who undergo cardiac surgery without having enough support. Exercise is recommended in such cases as it contributes heavily in addition to knowledge (Rollnick, Mason & Butter, 1999).
Discussion
Randomized control trial is an evidence-based practice that employs scientific methods to determine the truth of medical research (Fitzpatrick, 2000). This kind of research is relevant in the field of medicine since it helps to assess the evidence relating to a particular kind of treatment. According to Cullum et al (2008) “evidence-based practice recognizes that many aspects of health care depend on individual factors such as quality- and value-of-life judgments, which are only partially subject to scientific methods”. The outcomes considered in Goodman et al (2008) study were important; however, they should also consider the patients’ length of stay in hospital which is an important factor of the modern healthcare system. In addition, providing support as postoperative care for patients awaiting cardiac surgery is a cheap alternative for healthcare organizations and patients. Only a few studies measure direct or indirect costs, such as patients’ loss of outcomes (DiCenso, Guyatt & Ciliska, 2005). No harm or significant cost will result in applying the study’s intervention to other clinical settings. However, the “number needed to treat” (NNT) may need to be modified in the London clinical setting based on the reason for seeking healthcare (DiCenso, Guyatt & Ciliska, 2005).
Conclusion
Based on the critique of Goodman et al (2008), the study has shown that the intervention was not able to reduce the risk factors on patients due to undergoing CABG surgery. In addition, the intervention can not be in a position to improve the post-operation fitness but rather patients can be able to utilize the resources in a healthcare organization during the waiting period for cardiac surgery. The critique summarized the methods and the findings used in the study. In addition, the critical appraisal examined the results and assessed the value of the study for the nursing practice and patients A better program to reduce the risk factors would be to combine the current intervention with a cardiac rehabilitation center that offers exercise classes to enable patients to improve their fitness (Fitzpatrick, (2000).
References
Cullum, N. et al. (2008). Evidence-Based Nursing. An Introduction. Oxford: Blackwell.
DiCenso, A., Guyatt, G. & Ciliska, D. (2005). Evidence Based Nursing: A guide to clinical practice. Philadelphia: Mosby.
Fitzpatrick, M. (2000). The Tyranny of Health: Doctors and the Regulation of Lifestyle. New York: Routledge.
Goodman, H. et al. (2008). A randomised controlled trial to evaluate a nurse-led programme of support and lifestyle management for patients awaiting cardiac surgery, European Journal of Cardiovascular Nursing, 7 (1): 189-195.
Polit, D. & Beck, C. (2008). Nursing Research: Generating and assessing evidence for nursing practice. (8th Edition). Philadelphia: Lippincott Williams & Wilkins.
Rollnick, S., Mason, P. & Butter, C. (1999). Health Behaviour Change. Edinburgh: Churchill Livingstone.