Management of Chronic Pain in Adults: PICO - Assignment Example

Management of Chronic Pain in Adults: PICO Assignment Introduction Advanced malignancy care is a challenge to medical professionals like nurses for many reasons. Besides instituting various treatments that prevent progression of the disease, reduce development of complications and prolong life of the patient, nurses are also posed with a challenge of relieving devastating symptoms of the disease like pain which add to the miserable state of the patient. For those in terminal stages of cancer, provision of palliative care remains the only hope to relieve the patient from suffering to some extent (WHO, 2009). The corner stone of palliative care is pain management (WHO, 2009). This is because pain is very severe and distressing in cancer patients and can lead to physical disability, emotional maladjustment, social detachment, psychological depression and distress, sleep disturbances, loss of appetite, and feeling of unwell and above all make their journey to death miserable (National Health Service, 2006). In fact, pain is the only aspect of terminal illness that can be relieved. Nurses taking care of terminally ill cancer patients must be aware of this and take necessary measures to relieve pain in them (Kearney, Richardson, & Giulio, 2000). Round the clock administration of oral morphine for acute and chronic pain in patients with terminal and preterminal cancer is a widely accepted procedure. However, the need to administer the drug frequently and the increased risk of analgesic efficacy poses a problem in the management of pain in cancer patients. Several studies have reported other means of administration of opioid without altering the analgesic efficacy and without cumbersome dosing schedules. A couple of such important strategies are controlled-release morphine tablets and fentanyl-transdermal therapeutic system. To ascertain as to which is a better strategy for pain relief in cancer patients review of literature is essential. Making clinical decisions based on appropriate evidence is known as evidence-based practice. According to McKibbon (1998), "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. EBP values, enhances and builds on clinical expertise, knowledge of disease mechanisms, and pathophysiology. It involves complex and conscientious decision-making based not only on the available evidence but also on patient characteristics, situations, and preferences." Literature review is the most critical exercise for EBP. Literature search for EBP can be done effectively by creating appropriate question in PICO format. In this assignment, literature review for an evidence-based answer of a clinical question will be discussed after deciphering the question in PICO format. The literature search will be performed in a systematic manner through electronic databases. Clinical Question "In patients with terminal and preterminal cancer, which is the most appropriate strategy for pain relief? Oral sustained release morphine or transdermal fentanyl?" PICO Population: Patients with cancer in preterminal or terminal stages with acute or chronic pain Intervention: Orals sustained release morphine Comparison: Intradermal fentanyl Outcome: Relief from pain Evidence Investigation Selection criteria A. Inclusion criteria: 1. All studies pertaining to sustained release of oral morphine and transdermal fentayl-randomized control trials, meta analysis, systematic reviews, cross sectional studies, prospective longitudinal studies and retrospective studies were considered for the review. 2. Articles in English or those translated to English only were included because of the lack of knowledge of other languages by the reviewer. 3. Articles written between 1990 and 2007 only were considered to include latest information regarding the subject. 4. Mainly full text articles were considered for the study. In cases where full text articles are not available abstracts were used as proxy to full text articles. 5. Studies performed on adults only were included. B. Exclusion criteria 1. Articles not related to sustained release of oral morphine and fentanyl, or those related to these but are mainly descriptive or essay type was excluded in the study. 2. Articles not in English or not translated to English were excluded because of lack of understanding of other languages by the reviewer. 3. Articles posted anonymously in the internet were also excluded because these articles not necessarily impart genuine and authentic knowledge. 4. Articles on general pain management in cancer were also excluded because of lack of topic oriented discussions. 5. Articles on studies in children were also excluded. Search Process The commencement of search in electronic databases was based on the inclusion/exclusion criteria and knowledge of the hierarchies of evidence. Hierarchy provides a confidence measure to the end-user (Evans, 2003). According to Evans (2003), random control trials can be considered of good standard and they are in fact labeled as the gold standard of research for providing optimal research designs to answer pertinent questions. However, systemic reviews and meta-analysis have topped the hierarchy list. The databases used for search were PUBMED and CINAHL. The MESH terms used in PUBMED were cancer (neoplasm) (AND), morphine (AND), fentanyl (AND), & pain (AND). The limits used were adults and English. The search yielded 66 articles. The abstracts of all the articles were scanned and the following articles were retrieved for the review: Clemens and Klashik (2007), Mystakidou et al (2003), Payne et al (1998) and Wong et al (1997). In the CINAHL database, the search terms used were cancer (AND), morphine (AND), fentanyl (AND), & pain (AND). The search yielded 45 articles. The following article was retrieved from the database: Study by Ahmedazai and Brooks, 1997. It was noted that both search engines placed the results in a hierarchical order with the most relevant articles coming first or accorded higher star ratings. This search yielded valuable papers. Studies most appropriate for evidence-based practice were selected for the study. On the whole a total of 6 studies were selected based on inclusion and exclusion criteria and hierarchy of evidence (Refer to summary table in the Appendix). Critical appraisal of collective evidence Critical appraisal of the articles was done using Duffy's research appraisal for content analysis Validity and generalizability of the findings Literature review is nothing but a summary and evaluation on the credibility of a research which is directly dependent on the validity of the findings (Polit and Hungler 2007). Validity is a measure of the integrity of the drawn conclusions and is the actual truth-value of a study (Bryman 2004). Making decisions on the findings by looking at their relevance and applicability is an important aspect of critical review (Cutcliffe and Ward, 2003). Construct validity Construct validity may be defined as the extent to which a scale measures a certain construct (Parahoo, 2006) in which the link between conceptual definitions and operational definitions is examined. In all the nominal studies, construct validity was intact. This is because in all the studies oral sustained release morphine and transdermal fentanyl were used for the purpose of study and comparison. In all the studies, the participants were adult patients with cancer pain. Internal validity Internal validity is the extent to which the findings in the study reflect reality. It provides an effective measure in studies investigating causality (Burns & Grove, 1997). The factors attributed to internal validity are biases and confounders (Parahoo, 2006). The common confounding factors in all the studies were age, sex, stigma related to morphine, side effects and other management which may influence patient satisfaction and functional levels. Age is an important source of bias because those who are older experience more side effects to medications than who are younger. Sex also can influence the uptake of analgesics. As longitudinal studies clearly are dependent on observational designs, confounding may be an issue. Most of the studies attempted to adjust for confounding factors. However, confounding due to unmeasured factors can never be ruled out in observational studies. External validity and generalizability Generalizability is a measure of the applicability of study findings and conclusions to other similar settings and populations (Holloway & Wheeler, 2002). This aspect is important to know in the study because it gives an idea as to what extent the suggested causality is likely to hold true in other settings. The studies were conducted on patients with different types of cancer, different age groups (above 18 years) and different sexes. In the study by Payne et al, the participants were recruited from 68 different sites from the United States. In Wong et al, they were from a single location in the United States. In Mystakidou et al, patients were recruited from a single center in Athens. In the study by Ahmedzai and Brooks, patents were recruited from 38 different centers in the United Kingdom. In the study by Clemens and Klashik, patients were recruited from a single center in Germany. Thus the results of the literature review are generalisable. Rigour Rigour is the means to demonstrate integrity and competence and is determined by its truth value, applicability, consistency and neutrality (Holloway & Wheeler, 2002). It involves rigid adherence to research designs as mentioned in the methodology of studies and precise statistical analyses and can be influenced by poor observations and failure to utilise the available data (Burns & Grove 1997). In this review, all the five studies adhered to the research designs and methodology. The studies were pooled from different countries and time periods and hence there was no consistency maintained. The outcome measures were different in different studies. The main outcomes measured in Payne et al study were treatment satisfaction and sleep adequacy. Other outcomes which were measured were physical well being, emotional well being, functional well being, side effects, pain and symptomatology. In Wong et al, the main outcome measures were pain intensity, mood states, quality of sleep and activity status. In the study by Mystakidou et al, the outcome measures were pain control, quality of life and clinical and demographic data. The main outcome measures in Ahmedzai and Brooks (1997) were pain relief and quality of life. In Clems and Klashik (2007) study, the main outcome measure was pain. Another factor which was different in different studies is the type of cancer. Different participants in different studies had different types and stages of cancer. Thus it was difficult to demonstrate consistency in many studies. There was no attempt to give a clear and concise definition of the studied factors and the analyzed findings. Trustworthiness The quality of data and the confidence of data display was gauged based on trustworthiness. In all the studies, data was collected by the researchers through a set format. While in some studies like Payne et al, data was collected through questionnaire administration. In Wong et al, data collection was done using verbal 4(5)-point rank. Data collection in Mystakidou et al was performed using a visual analogue scale and patient diaries. In Ahmedzai and Brooks (1997), data collection was done through Quality of life questionnaire and Pain assessment cards. Clemens and Kaschil (2007) employed numerical rating score for data collection. Thus confirmability and meaningfulness of the studies could not be gauged properly in all cases. Hence there is scope for flawed data in the study. Statistical and clinical significance Analysis of quality-of-life data in Payne et al was conducted using SAS for Windows version 6.10. For both previously validated and constructed scales like satisfaction, basic validity analyses was performed. In Wong et al, unpaired Student's t-test, two way ANOVA, matched pairs test and U-tests were performed as appropriate. In Ahmedzai and Brooks (1997) data analysis was done using chi-square test and binomial test. In Clemens and Klaschik (2007) study, ANOVA, Wilcoxon and mean and standard deviation were employed. In the study by Mystakido et al, descriptive statistics and paired tests were used. All the statistical analyses were appropriate for the type of studies and the outcomes measured. The statistical significance of a study determines whether the findings occurred by chance or because of one or two extreme causes (Lanoe 2002). Collective evidence All the studies, except Payne et al opined that transdermal fentanyl was much more effective than oral sustained release morphine as afar as pain relief is concerned. Payne et al opined that both the drugs had similar attributes of pain relief but in those on transdermal fentanyl, fewer and less bothersome side effects were reported. In the study by Wong et al, the researchers found that dose was related to pain. Greater the intensity of pain, higher the doses. Also, patients on transdermal fentanyl had a weaker relationship between dose and sleep disturbance due to pain. In the study by Clemens and Klaschik, the researchers opined that morphine was a better drug because those in advanced stages of cancer had sweating and cachexia affecting transdermal absorption of fentanyl. In the study by Ahmedzai and Brooks, the authors opined that transdermal fentanyl provided better pain relief and lesser side effects like constipation and sedation when compared to morphine. In Mystakidou et al (2003) study, transdermal fentanyl was recommended as the first line approach to pain management in those with moderate and severe cancer related pain. Intervention decision For those who have moderate to severe cancer pain and who are suffering from side effects of oral morphine or have complications like nausea, vomiting and dysphagia, intradermal fentanyl must be tried. However, in patients with increased sweating and cachexia, transdermal fentanyl must not be recommended. References Ahmedzai, S., & Brooks, D. (1997). Transdermal fentanyl versus sustained-release oral morphine in cancer pain: Preference, efficacy, and quality of life. The TTS-Fentanyl comparative trial group. Journal of Pain and Symptom Management, 13(5), 254-261. Burns, N., Grove, S. K., 1997. The Practice of Nursing Research: Conduct, Critique and Utilisation. 3rd edition. Philadelphia: W. B. Saunders Co. Bryman, A., 2004. Social Research Methods. 2nd Edition. Oxford: Oxford University Press. Clemens, K. E., & Klashik, E. (2007). Clinical experience with transdermal and orally administered opioids in palliative care patients-a retrospective study. Japanese Journal of Clinical Oncology, 37(4), 302-309. Cutcliffe, J.R. and Ward, M., 2003. Critiquing Nursing Research. Dinton: Quay Books. Evans, D., 2003. Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions. Journal of Clinical Nursing, 12(1), p. 77 – 84. Kearney, N., Richardson, A., & Giulio, P. (2000). Cancer nursing practice a textbook for the specialist nurse. London: Churchill Livingstone. McKibbon KA (1998). Evidence based practice. Bulletin of the Medical Library Association, 86 (3), 396-401 Mystakidou, K., Tsilika, E., Parpa, E., Kouloulias, V., Kouvarts, I., & Vlagos, L. (2003).  Long-term cancer pain management in morphine pre-treated and opioid na?ve patients with transdermal fentanyl.  Int Journal Cancer, 107(3), 486-492. NHS Best Practice Statement. (2006). Management of chronic pain in adults. Retrieved on Retrieved on 4th April, 2010 from www.nhshealthquality.org Payne, R., Mathias, S. D., Pasta, D. J., Wanke, L. A., Williams, R. Mahmoud, R. (1998).  Quality of life and cancer pain:  Satisfaction and side effects with transdermal fentanyl versus oral morphine.  Journal Clinical Oncology, 16(4), 1588-1593. Parahoo, L., 2006. Nursing research: Principles, Process, and Issues. London: Macmillan. Polit, D. F., Hungler, B. P., 1997. Nursing Research: Principles and Methods. 5th edition. Philadelphia: J. B. Lippincott. WHO. (2009). WHO Definition of Palliative Care. Retrieved on 4th April, 2010 from http://www.who.int/cancer/palliative/definition/en/ Wong, J.O., Chiu, G., Tsao, C., and Chang, C. (1997). Comparison of oral controlled-release morphine with transdermal fentanyl in terminal cancer pain. Acta Anesthesiol Sin, 35, 25- 32. Appendix Study Research question Study design Sample size Inclusion criteria Exclusion criteria Results/Conclusion Level of significance Ahmedzai & Brooks, 1997 To compare transdermal fentanyl with SR oral morphine in adult EOL cancer pts with focus on patient preference and also side effects and effects on quality of life. Randomized Crossover Study  202 Adult cancer patients requiring strong opioid analgesia, on a stable dose of SR morphine for 48hrs Less than one month to live, unable to complete required assessments. Transdermal fentanyl provided better pain relief and lesser side effects like constipation and sedation when compared to morphine Level-2 Clemens and Klashik, 2007 Efficacy of transdermal fentanyl Retrospective descriptive analysis 81 NA NA Morphine was a better drug because those in advanced stages f cancer had swaeting and cachexia affecting transdermal absorption of fentanyl Level-6 Mystakidou et al, 2003 Safety and efficacy of transdermal fentanyl Open label prospective trial 589 Over 18 y/o, able to communicate pain level & QOL effectively, no opioid analgesia or oral morphine transferring to TSS-fentanyl, severe cancer pain, malignant cancer History of opioid abuse or an indication for no opioid use related to study Transdermal fentanyl was recommended as the first line approach to pain management in those with moderate and severe cancer related pain Level-4 Payne et al, 1998 Comparison of transdermal fentanyl and sustained release morphine in controlling analgesia in cancer patients Case study controlled cohort 504 At least 18y/o, dx with cancer, on pain med for 2 wks b/f entering study, knowledgeable of informed consent, able to comprehend English Not available The drugs had similar attributes of pain relief but in those on transdermal fentanyl, fewer and less bothersome side effects were reported Level-4 Wong et al Open comparitive and randomised controlled trial 40 Adults, with cancer pain, with atleast 2 months of survival time and required more than 404 grams of morphine per day. Hx narcotic abuse, opiod allergy, CO2 retention, creatinine> 2g per dl. Dose was related to pain. Greater the intensity of pain, higher the doses. Also, patients on transdermal fentanyl had a weaker relationship between dose and sleep disturbance due to pain Level2 A Table-1. Summary of Included Studies Read More