Background: Chronic non-cancer pain (CNCP) is a major health concern. Opioids may be a useful treatment option, but their use still remains controversial given the significant risks and epidemic of opioid addiction and abuse. There is limited data on whether opioid therapy is an effective treatment option for chronic non-cancer pain. Objective: To assess both physical and emotional dimensions of health for patients on opioid therapy for CNCP by reviewing the 36-Item Short Form Health Survey (SF-36) . Study Design: This study was a retrospective cohort review. Setting: Outpatient pain clinic Methods: We recruited 182 patients at the West Penn Pain Institute outpatient pain clinic: 94 patients were recruited for the low-dose opioid group (5-30 morphine milligram equivalents [MME]) while 88 patients were recruited for the high-dose opioid group (> 90 MME). Each patient filled out the SF-36 survey used to assess both the physical and emotional dimensions of their health. We also analyzed patients’ employment status, reasons for unemployment, pain diagnosis, side effects, and compliance issues through the electronic medical record (EMR). Results: Mean scores on General Health Perceptions for the low-dose and high-dose opioid groups were 50.3 ± 21.6 and 44.4 ± 21.9, respectively (P = .07). Though not reaching statistical significance, highdose patients had lower item scores, indicating a perception of poorer health. There were no significant differences between the low-dose and high-dose opioid treatment groups on any of the mean scores from the 8 domains of the SF-36. There was a statistically significant association between opioid treatment group and working status, noncompliance, and the self-reported number of side effects. Patients treated with high-dose opioids had significantly higher rates of unemployment (85%) than did low-dose opioid patients (66%) (χ2 [1] = 8.48, P =.004; odds ratio [OR] = 2.89 [95% confidence interval (CI), 1.39-6.01]). Unemployed patients in the highdose treatment group were more likely to list disability as unemployment while retirement was the most common response in the low-dose treatment group. Patients treated with high-dose opioids had significantly higher rates of self-reported side effects (46%) than did low-dose opioid patients (21%) (χ2 [1] = 12.02, P =.001; OR = 3.08 [95% CI, 1.61-5.89]). Patients treated with high-dose opioids had significantly higher rates of noncompliance (49%) than did low-dose opioid patients (33%) (χ2 [1] = 4.75, P =.029; OR = 1.94 [95% CI, 1.07-3.54]). Thus, the odds of a high-dose opioid patient being unemployed were 2.89 times greater than the odds for a low-dose opioid patient; the odds of a high-dose opioid patient self-reporting side-effects were 3.08 times greater than the odds for a low-dose opioid patient; and the odds of a high-dose opioid patient being noncompliant with their medications were 1.94 times greater than the odds for a low-dose opioid patient. Limitations: The observation al design prohibits drawing causal relationships, and entry criteria was restricted. Conclusions: These data suggest that patients receiving low-dose and high-dose opioid treatment do not have significantly different quality-of-life outcomes. Future studies that incorporate longitudinal data are necessary to examine the temporal relationship between quality of life and opioid therapy. Key words: Chronic pain, chronic non-cancer pain, opioids, pain, quality of life, side effects, noncompliance, unemployment
Background: Prescription drug abuse is the fastest growing drug problem in the United States, and the increase in unintentional drug overdose deaths has been driven by the increase in opioid analgesic use. Given the epidemic of non-medical prescription pain reliever use and the current medico-legal climate, it is increasingly important for the prescriber to monitor for medication compliance. Objectives: The purpose of this IRB approved study is to compare the results of oral fluid (OF) and routine urinalysis for monitoring compliance in a single academic pain management program in an urban setting in order to evaluate the utility of OF analysis in compliance monitoring when prescribing opioid medications. Study Design: Outcomes analysis of prospective, consecutive, paired comparison study with clinical implications. Setting: Single academic interventional pain management center in the United States. Methods: Paired OF and urine specimens were collected for each patient with signed informed consent, at the Institute for Pain Medicine, Western Pennsylvania Hospital, from patients who routinely donated urine on a random basis for compliance testing. A total of 153 paired specimens were analyzed. Demographic and prescription data were made available. Specimens were screened using immunoassay and presumptive positive findings were confirmed with liquid-chromatography and mass spectrometry. Although both matrices were tested for a wider range of medications, the data presented here are representative of analgesic opioids and benzodiazepine drug classes only. Results: Following exclusion criteria, of the 132 remaining specimen pairs that were positive for opioids or benzodiazepines in at least one matrix, 101 pairs showed exact drug class matches (76.5%). In an additional 21 pairs, at least one drug class was positive in both matrices (15.9%), giving an overall agreement of 92.4%. Overall, 191 positive results were found in urine averaging 1.4 drugs per specimen; 176 positives were detected using OF for an average of 1.3 drugs per specimen. Conclusions: In the setting of stable dosing of prescription opioids and/or concomitant illicit drug use, given comparable detection rates between urine and OF matrix qualitative results, the OF matrix for drug testing for compliance monitoring may serve as a useful and valid testing tool. The authors conclude that overall OF analysis produces comparable results to urine sample analysis with detection rates differing primarily due to differences in windows of detection for different drug classes. Limitations: The limitations include the study was performed in a single academic center in an urban community. Also, there is a paucity of literature regarding windows of detection for OF analysis compared to urine. IRB: APPROVED - Allegheny-Singer Research Institute West Penn Allegheny Heath System (ASRIWPAHS) - IRB Study #FWA00015120 Key Words: Urine drug testing, oral fluid drug testing, saliva, opioids, drug abuse, compliance, chronic pain, diversion
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