Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

Reduction of Postoperative Opioid Use After Elective Spine and Peripheral Nerve Surgery Using an Enhanced Recovery After Surgery Program.

OBJECTIVE: Enhanced recovery after surgery (ERAS) pathways have previously been shown to be feasible and safe in elective spinal procedures. As publications on ERAS pathways have recently emerged in elective neurosurgery, long-term outcomes are limited. We report on our 18-month experience with an ERAS pathway in elective spinal surgery. METHODS: A historical cohort of 149 consecutive patients was identified as the control group, and 1,141 patients were prospectively enrolled in an ERAS protocol. The primary outcome was the need for opioid use one month postoperation. Secondary outcomes were opioid and nonopioid consumption on postoperative day (POD) 1, opioid use at three and six months postoperation, inpatient pain scores, patient satisfaction scores, postoperative Foley catheter use, mobilization/ambulation on POD0-1, length of stay, complications, and intensive care unit admissions. RESULTS: There was significant reduction in use of opioids at one, three, and six months postoperation (38.6% vs 70.5%, P < 0.001, 36.5% vs 70.9%, P < 0.001, and 23.6% vs 51.9%, P = 0.008) respectively. Both groups had similar surgical procedures and demographics. PCA use was nearly eliminated in the ERAS group (1.4% vs 61.6%, P < 0.001). ERAS patients mobilized faster on POD0 compared with control (63.5% vs 20.7%, P < 0.001). Fewer patients in the ERAS group required postoperative catheterization (40.7% vs 32.7%, P < 0.001). The ERAS group also had decreased length of stay (3.4 vs 3.9 days, P = 0.020). CONCLUSIONS: ERAS protocols for all elective spine and peripheral nerve procedures are both possible and effective. This standardized approach to patient care decreases opioid usage, eliminates the use of PCAs, mobilizes patients faster, and reduces length of stay.

The Initiation of Chronic Opioids: A Survey of Chronic Pain Patients.

This study reports the results of a researcher-administered survey with 115 patients receiving chronic opioid therapy (>90 days) to obtain information regarding how chronic opioid therapy was started. Chronic opioids were started after surgery (27.0%, 95% confidence interval [CI], 18.5-35.5) or for the treatment of acute injury-related pain (27.0%, 95% CI, 18.5-35.5). Many who initiated opioid therapy after surgery reported postoperative complications (61.3%, 95% CI, 50.8-71.8) and many with injury-related pain reported follow-up corrective surgery (58.1%, 95% CI, 47.5-68.7), which led to the continuation of opioids. A large percentage of patients had concurrent depression (43.5%, 95% CI, 34.0-53.0) and anxiety (23.5%, 95% CI, 15.3-31.7). Many participants had a medical history of aberrant drug-related behavior (32.5%, 95% CI, 23.5-41.5) and self-reported history of addiction (21.7%, 95% CI, 13.7-29.7). Almost one-quarter reported taking opioids for a different indication than that for which opioids were started (95% CI, 26.6-45.0). Patients receiving long-term opioid therapy often transitioned to chronic use after starting opioids for the short-term treatment of postoperative or injury-related pain. It is not evident if a clear decision to continue opioids on a chronic basis was made. This survey provides insight as to how chronic opioid therapy is started, and may suggest opportunities for improved patient selection for opioid therapy. PERSPECTIVE: This article explores the reasons why patients using chronic opioid therapy (>90 days) initiated opioid medications. The results of this study may help clinicians better select patients for chronic opioid therapy.

Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

Can assessing chronic pain outcomes data improve outcomes?

OBJECTIVE: This manuscript reviews how patient-reported outcomes data can be used to guide efforts to improve patient outcomes. DESIGN: Review Manuscript. SETTING: The clinical management of chronic, non-cancer pain. SUBJECTS: Adult patients receiving treatment for chronic, non-cancer pain. RESULTS: While there have been great advances in the science of pain and various therapeutic medications and interventions, patient outcomes are variable. This manuscript reviews how outcomes data can be used to guide efforts to improve patient outcomes. CONCLUSIONS: Patient outcomes can be improved with standardization of the process of patient care, as well as through other quality improvement efforts. The cornerstone to any effort to improve patient outcomes starts with the integration of valid outcomes data collection into ongoing patient care. Outcome measurement tools should provide information on several key domains, yet the process of data collection should not pose a significant burden on either the patient or health care team. Efforts to improve patient outcomes are ongoing, and should be a high priority for every health care team.

Primary care physician opinion survey on FDA opioid risk evaluation and mitigation strategies.

INTRODUCTION: In response to disturbing rises in prescription opioid abuse, the Food and Drug Administration (FDA) has proposed the implementation of aggressive Risk Evaluation and Mitigation Strategies (REMS) that will require prescribers to obtain mandatory education, provide mandatory patient education, register patients into registries, and so forth before prescribing certain opioids. The first opioid to be subject to the new REMS was the recently approved fentanyl buccal soluble film (Onsolis). The FDA plans to extend mandatory REMS to other opioids, including all rapid-onset formulations and eventually all long-acting opioids, whether or not they already have FDA approval. To assess the likely impact of REMS on opioid prescribing, the authors conducted a survey of how REMS implementation might affect opioid prescribing. METHODS: After obtaining Institutional Review Board's approval, a survey regarding opioid prescribing was sent via e-mail to 2,800 physician members of the Pennsylvania Academy of Family Physicians. Practicing family practice physicians were asked to respond to questions regarding their current opioid prescribing, and how various components of REMS might alter their future opioid prescribing. RESULTS: A total of 259 surveys were completed. Of the 259 physicians who responded, 87 percent reported themselves as being primary care practitioners; others identified themselves as specialists. Of all respondents, 96 percent currently prescribe opioids for acute pain, 77 percent for cancer pain, and 83 percent for chronic nonmalignant pain. The respondents were split from 52 percent to 48 percent in terms of being in an urban versus a rural practice setting. Forty eight percent of all respondents reported their willingness to complete no more than 2 hours of training if it were available locally to be able to continue prescribing opioids. A similar percentage (50 percent) also said that they would encourage patient compliance with education and register their patients on a 6-month basis. However, the following percent of respondents reported that they would discontinue prescribing an opioid product if required to comply with the following REMS requirement: obtain 4-8 hours of straining, followed by 2 hours of pain-related continuing medical education every 2 years (13.4 percent); complete mandatory patient education (12.2 percent); document ongoing monitoring of therapy including efficacy, safety, and monitoring for aberrant drug-related behavior (10.4 percent); or register each patient in a patient registry, and have the patient re-registered every 6 months (18.3 percent). CONCLUSIONS: The results suggest that 50 percent of the responding physicians would be willing to comply with the mandatory education component of REMS, including the requirement to provide education to patients. For some REMS components, willingness to continue to prescribe despite the restriction was higher (up to 90 percent). However, this leaves a substantial proportion of physicians who would not be willing to prescribe opioids controlled by the new REMS, which could have the unintended effect of decreasing access to these medications for legitimate medical purposes.

An organized, comprehensive, and security-enabled strategic response to the Haiti earthquake: a description of pre-deployment readiness preparation and preliminary experience from an academic anesthesiology department with no preexisting international disaster response program.

BACKGROUND: On Tuesday, January 12, 2010 at 16:53 local time, a magnitude 7.0 M(w) earthquake struck Haiti. The global humanitarian attempt to respond was swift, but poor infrastructure and emergency preparedness limited many efforts. Rapid, successful deployment of emergency medical care teams was accomplished by organizations with experience in mass disaster casualty response. Well-intentioned, but unprepared, medical teams also responded. In this report, we describe the preparation and planning process used at an academic university department of anesthesiology with no preexisting international disaster response program, after a call from an American-based nongovernmental organization operating in Haiti requested medical support. The focus of this article is the pre-deployment readiness process, and is not a post-deployment report describing the medical care provided in Haiti. METHODS: A real-time qualitative assessment and systematic review of the Hospital of the University of Pennsylvania's communications and actions relevant to the Haiti earthquake were performed. Team meetings, conference calls, and electronic mail communication pertaining to planning, decision support, equipment procurement, and actions and steps up to the day of deployment were reviewed and abstracted. Timing of key events was compiled and a response timeline for this process was developed. Interviews with returning anesthesiology members were conducted. RESULTS: Four days after the Haiti earthquake, Partners in Health, a nonprofit, nongovernmental organization based in Boston, Massachusetts, with >20 years of experience providing medical care in Haiti contacted the University of Pennsylvania Health System to request medical team support. The departments of anesthesiology, surgery, orthopedics, and nursing responded to this request with a volunteer selection process, vaccination program, and systematic development of equipment lists. World Health Organization and Centers for Disease Control guidelines, the American Society of Anesthesiology Committee on Trauma and Emergency Preparedness, published articles, and in-country contacts were used to guide the preparatory process. CONCLUSION: An organized strategic response to medical needs after an international natural disaster emergency can be accomplished safely and effectively within 6 to 12 days by an academic anesthesiology department, with medical system support, in a center with no previously established response system. The value and timeliness of this response will be determined with further study. Institutions with limited experience in putting an emergency medical team into the field may be able to quickly do so when such efforts are executed in a systematic manner in coordination with a health care organization that already has support infrastructure at the site of the disaster.

Conversion to oral controlled-release oxycodone from intravenous opioid analgesic in the postoperative setting.

OBJECTIVE: This study assessed conversion factors utilized by physicians to transfer postoperative patients from intravenous opioids to oral controlled-release (CR) oxycodone and the subsequent analgesic effectiveness. DESIGN: This was a multicenter, open-label, usual-use study of 189 hospitalized postoperative patients receiving opioid (usually morphine) intravenous patient-controlled analgesia (IV PCA) for at least 12 to 24 hours post-procedure. Patients who were tolerant of oral medications and without signs of paralytic ileus were converted to oral CR oxycodone, given every 12 hours for up to 7 days. RESULTS: The mean (+/-SE) conversion factor used to convert IV PCA morphine to CR oxycodone was 1.2 +/- 0.1 (N=159). The initial CR oxycodone doses, based on individual conversion factors from IV PCA morphine, produced significant reductions in pain intensity (scores