Pain Control for CaP Patients Receiving HDR Brachytherapy
Applying research findings to support the practice of nursing is essential to the nursing profession as intellectual foundations continue to increase. Many institutions are implementing the concept of applying evidence through policy and procedure committees that are operating on evidenced-based practice models and performance improvement projects. Other practitioners individually look for the best evidence to support and improve care of particular clients. Most professions use current and prior relevant information to determine best practice. To do so decreases the uncertainty of what nurses do (Melnyk & Fineout-Overholt, 2005) and promotes confidence in care provided.
Students lament the fact that they are required to take statistics and research courses. It is only recently that many have begun to recognize the importance of examining evidence to provide a basis for care that is given. Students, especially graduate students, still want clinical expertise to have value and think that it may be undervalued in this process. Those who support evidence-based practice indicate that clinical expertise and patient preferences are important when considering practice changes (Melnyk & Fineout-Overholt, 2005).
Critical review of research and performance improvement projects assists clinicians in the decision about the evidence that will be useful to clinical practice. The outcome of the review will be the focus of this column. Examination of the performance improvement projects or research studies that are published in Urologic Nursing and a critique of each area of the project or study will enable decisions about applicability of findings to the practice of urologic nursing. As the critique progresses, some tutorial information to help the reader understand the research or performance improvement process and gain skills in critiquing the literature will be provided. The importance of critically examining research cannot be emphasized enough. Results of research that encourage practice changes should be reliable and valid. Additionally, the literature base that exists should offer strong support to the current study or project. With the goal of assuring the highest quality of care for patients, increasing knowledge about the research critique process and subsequently adding evidence to the knowledge base of the profession will only enhance the care decisions in the practice of nursing.
When critically evaluating any project report or research study, the reader should begin with the problem statement, purpose, questions, literature base, methodology that includes the design of the study, and continue by looking at the results and conclusions stated by the researchers (Polit & Beck, 2004). This current published project report provides important information to guide practice in pain control for patient's receiving high-dose rate (HDR) brachytherapy for prostate cancer (Collela et al., 2006; see page 57 of this issue). As the authors note, related to the manner in which the therapy for the cancer is delivered, these patients experience significant pain during the 36 hours of hospitalization for the brachytherapy. Thus, the problem area is clearly identified. However, supporting the problem area within text citations of references about brachytherapy would enhance the reader's identification of the importance of this problem area.
Along with the problem area, the purpose of the study was also clearly identified and was stated to be a performance improvement project that would determine the best of two separate methods of pain control for patients with prostate cancer receiving HDR brachytherapy. The authors indicated that their institution did not require the institutional review process because of the performance improvement nature of the study. Institutional review board review is an important and necessary component of research because it protects human subjects from projects or research that may be unethical, too invasive, or too risky (Polit & Beck, 2004). It is not, however, necessary for performance improvement projects that seek to change one or more methods of improving care of clients.
Variables in the project are the intervention or independent variable that is the method of pain control and the dependent or outcome variable that is the patient's pain. Two questions were identified as being at the core of the project, one of which included these variables. However, the second question suggests an additional outcome variable of improved patient satisfaction with pain management. Patient satisfaction does not appear to have been measured within the context of the performance improvement project. It was measured by institutional patient satisfaction surveys and not necessarily with the group of patients in the current project. Patient satisfaction may have been assumed by the authors because pain management was improved with one pain control method.
Additional questions that could help guide the study might include the effects of the potential confounders and the difference in drugs used, as well as the difference in the presence of basal rate on patient controlled epidural analgesia (PCEA) or spinal route and patient controlled analgesia (PCA) or peripheral intravenous route. Confounders are variables in a study that influence the outcomes of the study but may not be included in the measurement process (Norwood, 2000; Polit & Beck, 2004). This concept will become more clear as subsequent projects or studies are reviewed. The study design might have included some greater equivalence of the PCA and PCEA by examining the pain management methods with or without a basal rate of the drug, and by examining both PCA and PCEA with a similar drug as other studies have done (Correll, Viscusi, Grunwald, & Moore, 2001; Vasilakos, Trikoupi, & Kesisoglou, 2004). Given that the finding of better pain management with PCEA was actually due to the method itself and not extraneous, confounding variables such as the lack of a basal rate on both PCA and PCEA or different drugs used in each of the methods, clinicians could have greater confidence in the findings.
A strength of the report was the complete literature review. Numerous studies exist on the effects of PCA and PCEA individually. Fewer studies are available on the comparison of the two methods on any type of patient. None were found specifically for patients undergoing HDR brachytherapy. Thus, this gap in the literature indicates support for the information this project can contribute to the body of knowledge regarding effective pain control for patients receiving HDR brachytherapy.
The project design was a comparison of two groups of patients who were receiving different types of pain management to assess the most effective method. When the goal of a project or study is to determine the most effective method of managing a patient's care, the comparative design is very appropriate. In the case of the current performance improvement project, the comparative design was effective. The authors chose a nonrandomized, convenience sample of patients who were easily available in their institution. PCA patients were measured in the first phase of the study and PCEA patients were assessed and measured in the second phase of the study. A convenience sample was appropriate for this performance improvement project since the goal of the project is to improve the pain management of patients with prostate cancer who receive HDR brachytherapy in the authors' institution. Randomization of a sample allows researchers to apply their findings to other similar groups of patients in other institutions given significance of the findings. When randomization is not accomplished, larger sample sizes help to assure that participants in the sample represent the population being studied, patients with prostate cancer receiving HDR brachytherapy in this case. However, neither randomization nor large sample size are necessary conditions of this performance improvement project since the authors wanted to find the best method for the patients in their own institution. Should this project be replicated as a formal research study, randomization of the sample as well as sample size would be important considerations.
Internal validity refers to the truth of findings of the study (Norwood, 2000; Polit & Beck, 2004). Given that group differences were not addressed and that drugs used in the PCA and PCEA were different, one cannot conclude with accuracy that pain control occurred because of the use of the PCEA method. The authors did not indicate the characteristics of each group or if this had been assessed. It is possible that the PCEA group had fewer co-morbid illnesses or fewer high dose rate brachytherapy catheters to contribute to the pain. Thus, group differences in pain control, although significant, may not be because of the PCEA but because of the difference in the drug therapy or presence of other group differences.
The authors reported that the reliability and validity of the Brief Pain Inventory Scale is "reasonable." Reliability and validity information are needed not only for previous use of the instrument but as a measure in the current project. Knowing the measure of reliability as well as the validity is important to determine if the measurement tool is measuring what it says it does and if it is consistent in doing so. For this project, the tool was effective in its measurement but actual reliability and validity information was not known.
Statistically, the t-test was a very good choice for measurement in the project design. The t-test is used when comparison of two groups on some characteristic is desired. In this case, two separate groups of HDR brachytherapy patients were compared on different pain medication delivery methods. To apply this statistical procedure, the data from these groups must be normally distributed with similar standard deviations meaning that the data cannot have extreme scores that cause it to be skewed in a positive or negative direction (Munro, 2005). The data produced by the pain scale used in this project is at an appropriate level that can be measured by the t-test of groups differences.
Multivariate statistics were used to find any independent predictors that contributed to the pain of the HDR brachytherapy patients. Any variables that might have influenced the outcome of the project can be examined with multivariate analysis. Multivariate analysis allows for correlations to show relationships among many variables. In this project, the number of catheters, presence of diabetes, arthritis, obesity, back pain, Foley catheter pain, and perineal catheter pain were variables that were included in the multivariate analysis. It is an appropriate method of analysis for this purpose and did show that Foley catheter pain was worse with patients who were obese or had arthritis, providing implications for practitioners who work with these complex patients while they receive HDR brachytherapy. Other variables that might have altered the results of the project, such as the presence of a basal rate and difference in medications used in the PCEA and PCA, could also have been included in this analysis to enhance study findings and eliminate the possibility that they were responsible for the outcome of the study rather than the PCEA method itself.
Additional studies comparing PCA and PCEA (Correll et al., 2001; Vasilakos et al., 2004) support the conclusions of the authors that PCEA is a very good method of pain management in a postoperative phase of patient care. These studies were both randomized in their design and compared similar drugs and similar applications of basal rates along with bolus dosing, thus, strengthening the conclusions that they reached.
The authors of the project very appropriately identified several limitations of their project including the differences in the medications used in the PCEA and PCA along with the differences in the basal rate and demand dosing. Although generalization to the broader population is not possible from this project, it did identify an important gap in the literature that created the need for this study. As mentioned earlier, the project results do contribute important information to the body of knowledge of pain management with PCA and PCEA as well as for patients receiving HDR brachytherapy. Further examination with a research study design that includes randomization of the study sample of participants will strengthen the authors' conclusion that a practice change should occur to include the use of PCEA to manage the pain of patients with prostate cancer receiving HDR brachytherapy.
How the evidence found in this study is applied to practice becomes the collaborative decision of clinicians in the setting where the study was conducted. The authors chose, in the nursing implications section, to focus on patient satisfaction as a reason to implement the practice change in pain management. While one could not disagree that a patient's satisfaction with care is extremely important, patient satisfaction was not measured with these study participants. Given the information available to reviewers of these study results, it seems most appropriate to focus on the pain relief achieved with the PCEA method.
Although the project design was not as strong due to lack of randomization and confounding variables that were not statistically included in the study, the results do have some clinical significance as well statistical significance for two reasons: (a) because of the support that the literature provides, and (b) because this current study did find that PCEA patients had better pain management. Correll et al. (2001) and Vasilakos et al. (2004) support the use of PCEA in the practice of pain control for postoperative patients. Since both studies were randomized controlled trials, they have strength to suggest a practice change. In the case of this project, it is likely that the authors will choose a practice change since their patients had good pain relief with the PCEA. While their project contributes to the evidence base, it is not rigorous enough, from a research perspective, to change practice. Studies, such as the ones mentioned in the literature review and those mentioned previously, may contribute more strongly to the preference of PCEA over PCA for pain management in certain postoperative patients. However, even in randomized controlled trials, the significance level must be rigorous to minimize the possibility of Type I errors of research.
The authors of this project could decide to strengthen their design in a separate study to increase the external validity for the population they are studying. Given a more rigorous study that produced similar results, they would provide evidence to support a change in practice for patients undergoing HDR brachytherapy.
With the evidence provided by the current project results, a practice change could occur at the authors' health care institution. Adding clinical expertise and patient preference information to the project results will also assist clinicians to use this evidence to move forward with implementing a change in practice. Further, the decision is likely to be unit based or determined by a committee in the institution followed by subsequent policy development. The quality of care will be improved for patients at this institution and clinicians will have more confidence that the pain management method supported in the study is, in fact, the best practice for patients with prostate cancer. Other practitioners should view these results as data that apply to one health care institution. To change practice, the "gold standard" of research is a large, multicenter, randomized, controlled trial that provides results that are sufficient to avoid errors (personal communication, M.G. Karlowicz, November 27, 2005). Thus, at this time, results of the current project encourage clinicians to further examine the practice of PCEA pain management and they support an improvement in pain management at the institution where this project was conducted. Alone, they do not support a change in practice for patients elsewhere until further study is completed.
The print version of this article was originally certified for CE credit. For accreditation details, please contact Urologic Nursing, East Holly Ave Box 56, Pitman, NJ 08071, Email: uronsg@ajj.com .
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