Acute Pain in Perspective.

KEY TAKEAWAYS: Acute pain is a common and nearly universal experience that usually has a sudden onset and is limited in duration. It is a normal physiologic response to a noxious stimulus that can become pathologic if untreated or not treated effectively. Acute pain has a limited duration (<1 month) and often is caused by injury, trauma, or medical treatments such as surgery. Primary care practitioners (PCPs) who encounter patients with acute pain can help preserve function and quality of life and prevent progression to chronic pain by implementing appropriate management strategies. PCPs in rural settings may bear greater responsibility for acute pain management because of the lack of accessible specialists. All current guidelines support using a multimodal approach to pain management and reserving use of opioids for patients with severe pain that cannot be managed with other agents. There are several new agents and formulations recently approved or in development for the treatment of acute pain. The recently approved co-crystal formulation of celecoxib and tramadol hydrochloride provides an additional option for acute pain management and utilizes a single-medication multimodal approach.

Dose-response of pregabalin for diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia.

OBJECTIVES: The pregabalin dose-response for pain, Patient Global Impression of Change (PGIC), and sleep quality measures in painful diabetic peripheral neuropathy (pDPN), postherpetic neuralgia (PHN), and fibromyalgia (FM) is relevant for physicians treating these patients. This analysis aimed to demonstrate the dose-response of pregabalin for each indication and describe the onset (incidence), onset/continuation (prevalence), and resolution of adverse events (AEs) occurring during treatment. METHODS: Data from 14 placebo-controlled, fixed-dose pregabalin trials in pDPN, PHN, and FM were pooled within each indication. Patients had mean baseline pain scores ≥6 on an 11-point numeric rating scale. A hyperbolic Emax dose-response model examined the dose-response of pregabalin for pain, PGIC, and sleep quality. Safety assessments included onset and prevalence of common AEs each week, and resolution in the first 2 months of treatment. RESULTS: In all indications, the likelihood of patients experiencing pain relief and improvements in PGIC and sleep quality increased in a dose-dependent manner with increasing doses. In all indications, new incidences of dizziness and somnolence were highest after 1 week of treatment, with few subsequent new reports at a given dose. Prevalence rates decreased steadily after 1 week of treatment. In FM, new onset weight gain emerged 6-8 weeks following treatment; prevalence rates generally increased then remained steady over time. With the exception of weight gain, many AEs resolved in month 1. CONCLUSION: The dose-response of pregabalin for pain, PGIC, and sleep quality was demonstrated, highlighting the benefit of achieving the maximum recommended dose of 300 mg/day for pDPN, 300-600 mg/day for PHN, and 300-450 mg/day for FM. Common AEs are generally seen within 1 week of starting treatment, with few subsequent new reports at a given dose. New onset weight gain occurs after 6 weeks of treatment, reinforcing the need for regular monitoring of weight.

Variations in the management of fibromyalgia by physician specialty: rheumatology versus primary care.

PURPOSE: To evaluate the effect of physician specialty regarding diagnosis and treatment of fibromyalgia (FM) and assess the clinical status of patients initiating new treatment for FM using data from Real-World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments. PATIENTS AND METHODS: Outpatients from 58 sites in the United States were enrolled. Data were collected via in-office surveys and telephone interviews. Pairwise comparisons by specialty were made using chi-square, Fisher's exact tests, and Student's t-tests. RESULTS: Physician specialist cohorts included rheumatologists (n=54), primary care physicians (n=25), and a heterogeneous group of physicians practicing pain or physical medicine, psychiatry, neurology, obstetrics and gynecology, osteopathy, or an unspecified specialty (n=12). The rheumatologists expressed higher confidence diagnosing FM (4.5 on a five-point scale) than primary care physicians (4.1) (P=0.037). All cohorts strongly agreed that recognizing FM is their responsibility. They agreed that psychological aspects of FM are important, but disagreed that symptoms are psychosomatic. All physician cohorts agreed with a multidisciplinary approach including nonpharmacological and pharmacological treatments, although physicians were more confident prescribing medications than alternative therapies. Most patients reported moderate to severe pain, multiple comorbidities, and treatment with several medications and nonpharmacologic therapies. CONCLUSION: Physician practice characteristics, physician attitudes, and FM patient profiles were broadly similar across specialties. The small but significant differences reported by physicians and patients across physician cohorts suggest that despite published guidelines, treatment of FM still contains important variance across specialties.

Rethinking chronic pain in a primary care setting.

Chronic pain substantially impacts patient function and quality of life and is a burden to society at large in terms of increased health care utilization and loss of productivity. As a result, there is an increasing recognition of chronic pain as a public health crisis. However, there remains wide variability in clinical practices related to the prevention, assessment, and treatment of chronic pain. Certain fundamental aspects of chronic pain are often neglected including the contribution of the psychological, social, and contextual factors associated with chronic pain. Also commonly overlooked is the importance of understanding the likely neurobiological mechanism(s) of the presenting pain and how they can guide treatment selection. Finally, physicians may not recognize the value of using electronic medical records to systematically capture data on pain and its impact on mood, function, and sleep. Such data can be used to monitor onset and maintenance of treatments effects at the patient level and evaluate costs at the systems level. In this review we explain how these factors play a critical role in the development of a coordinated, evidence-based treatment approach tailored to meet specific needs of the patient. We also discuss some practical approaches and techniques that can be implemented by clinicians in order to enhance the assessment and management of individuals with chronic pain in primary care settings.

SoluMatrix® Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain.

OBJECTIVES: To evaluate opioid rescue medication usage and the opioid-sparing effect of low-dose SoluMatrix® diclofenac developed using SoluMatrix Fine Particle Technology™ in a phase 3 study in patients experiencing pain following bunionectomy surgery. DESIGN: Multicenter, randomized, double-blind, parallel-group study (NCT01462435). SETTING: Four clinical research centers in the United States. SUBJECTS: Four hundred twenty-eight patients aged 18 to 65 years who experienced moderate-to-severe pain following bunionectomy surgery. METHODS: Patients were randomized to receive low-dose SoluMatrix diclofenac 35 mg or 18 mg capsules three times daily (35-mg group or 18-mg group), celecoxib 400 mg loading dose followed by 200-mg capsules twice daily (celecoxib 200-mg group), or placebo capsules postsurgery. Patients were permitted to receive opioid-containing rescue medication as needed. RESULTS: Significantly fewer patients who received SoluMatrix diclofenac 35 mg or 18 mg or celecoxib required rescue medication during 0-24 h and >24-48 h postsurgery compared with placebo. Patients in the SoluMatrix diclofenac 35 mg or 18 mg groups or in the celecoxib group used fewer mean rescue medication tablets over 0-24 h and >24-48 h compared with placebo-treated patients. Patients in the SoluMatrix diclofenac 35 mg and 18 mg groups and in the celecoxib group also required rescue medication at later times and at slower rates compared with placebo-treated patients. No serious adverse effects occurred in patients receiving SoluMatrix diclofenac. CONCLUSIONS: SoluMatrix diclofenac at two dosage strengths demonstrated an opioid-sparing effect postoperatively in this phase 3 study. SUMMARY: The opioid-sparing effect following low-dose SoluMatrix diclofenac (35 mg or 18 mg three times daily) administration was evaluated in patients experiencing pain following bunionectomy. Significantly fewer patients receiving SoluMatrix diclofenac or celecoxib (400 mg loading, 200 mg twice daily) required rescue medication during 0-24 h and >24-48 h following bunionectomy compared with placebo. No serious adverse events were reported among patients who received SoluMatrix diclofenac. SoluMatrix diclofenac may reduce opioid usage in the postoperative setting in patients with acute pain.

Long-term evaluation of opioid treatment in fibromyalgia.

OBJECTIVES: In a 12-month observational study, we evaluated the effect of opioid use on the outcomes in 1700 adult patients with fibromyalgia. METHODS: Data were evaluated using propensity score matching after patients were divided into cohorts based on their baseline medication use: (1) taking an opioid (concurrent use of tramadol was permitted); (2) taking tramadol (but no opioids); and (3) not taking opioids or tramadol. Changes in outcomes were assessed using the Brief Pain Inventory for severity and pain-related interference (BPI-S, BPI-I), Fibromyalgia Impact Questionnaire (FIQ), Patient Health Questionnaire for depression (PHQ-8), Insomnia Severity Index (ISI), Sheehan Disability Scale (SDS), 7-item Generalized Anxiety Disorder Scale (GAD-7), and economic factors. Time-to-opioid or tramadol discontinuation was analyzed using Kaplan-Meier survival analyses. RESULTS: Compared with the opioid cohort, the nonopioid cohort demonstrated significantly greater reductions (P<0.05) in BPI-I, FIQ, PHQ-8, SDS, and ISI; the tramadol cohort compared with the opioid group showed greater reductions on FIQ and ISI. Reductions in BPI-S and GAD-7 did not differ significantly among cohorts. Compared with the opioid cohort, patients in the tramadol cohort had fewer outpatient visits to health care providers. Few significant differences were found between the tramadol and nonopioid cohorts across outcomes. DISCUSSION: Although pain severity was reduced over time in all cohorts, opioid users showed less improvement in pain-related interference with daily living, functioning, depression, and insomnia. Overall, the findings show little support for the long-term use of opioid medications in patients with fibromyalgia given the poorer outcomes across multiple assessment domains associated with this cohort.

NSAIDs in the older patient: balancing benefits and harms.

OBJECTIVE: The older person is more likely to have pain since degenerative diseases and the effects of cancer are more common after 65 years of age. Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used due to perceived safety, relatively low cost and over-the-counter availability. This brief review describes the necessity for, but risks of, NSAIDs in the older patient. DESIGN: A literature search was undertaken using PubMed and search terms including pain, aging, treatment, nonsteroidal anti-inflammatory drugs, arthritis, older patient, and guidelines. CONCLUSIONS: Pain complaints are common in the older population. Low back pain and osteoarthritis affects over two thirds of this group. Patients and clinicians are increasingly wary about treatment since no medication appears to be safe. Older patients opting for no treatment may have worsening function including decreased sleep, mobility, socialization, and increased depression. Ninety percent of all prescription NSAIDs are taken by patients over 65. Guidelines for safe use are available but frequently not followed by the practitioner including the FDA recommended "lowest dose possible for your treatment … for the shortest time needed." NSAIDs can be an effective treatment option for many older persons but caution should be exercised in this often fragile population.

Integrating health information technology and electronic health records into the management of fibromyalgia.

Fibromyalgia (FM) is a widespread chronic pain condition that represents a significant economic burden for patients and health care systems. Effective treatment of FM requires a multidisciplinary management strategy that incorporates pharmacologic and nonpharmacologic therapy. Steps such as reducing the time to diagnosis and improving treatment decisions can result in significant cost savings and improved patient outcomes. An FM management framework, based on patient education and goal setting, has emphasized the need for ongoing care of patients with FM. In this article, we discuss how this framework could be further improved through the use of health information technology, including electronic health records. Health information technology/electronic health records can be incorporated at every stage of patient care, from initial presentation to diagnosis, through to making treatment decisions and maintaining ongoing patient management. This can lead to a number of potential benefits for patients with FM (by improving their level of care), primary care providers (by creating greater efficiencies), and the health care system (by reducing costs). Ultimately, the treatment and care of patients with FM need be no more burdensome to primary care providers than any other chronic illness. Through the greater efficiencies and optimized treatment approaches facilitated by health information technology/electronic health records, it should be possible to drive best-practice care for patients with FM and improve patient outcomes.

Longitudinal observation of treatment patterns and outcomes for patients with fibromyalgia: 12-month findings from the reflections study.

OBJECTIVE: To describe 12-month treatment patterns and outcomes for patients starting a new medication for fibromyalgia in routine clinical practice. DESIGN AND OUTCOME MEASURES: Data from 1,700 patients were collected at baseline and 1, 3, 6, and 12 months. Repeated measures and Poisson regression models controlling for demographic, clinical, and baseline outcomes were used to assess changes in health outcomes (Brief Pain Inventory severity and interference, Sheehan Disability Scale, Fibromyalgia Impact Questionnaire), satisfaction, and economic factors for patients who initiated on pregabalin (214, 12.6%), duloxetine (264, 15.5%), milnacipran (134, 7.9%), or tricyclic antidepressants (66, 3.9%). Sensitivity analyses were run using propensity-matched cohorts. RESULTS: Patients started on 145 unique drugs for fibromyalgia, and over 75% of patients took two or more medications concurrently for fibromyalgia at each time point assessed. Overall, patients showed improvement on the four health outcomes, with few differences across medication cohorts. At baseline, patients reported annual averages of 20.3 visits for outpatient care, 27.7 missed days of work, and 32.6 days of care by an unpaid caregiver. The duloxetine and milnacipran (vs pregabalin or tricyclic antidepressant) cohorts had fewer outpatient visits during the 12-month study. Patients reported satisfaction with overall treatment and their fibromyalgia medication (46.0% and 42.8%, respectively). CONCLUSIONS: In this real-world setting, patients with fibromyalgia reported modest improvements, high resource, and medication use, and were satisfied with the care they received. Cohort differences were difficult to discern because of the high rates of drug discontinuation and concomitant medication use over the 12-month study period.

A preliminary study to determine if a muscle pain protocol can produce long-term relief in chronic back pain patients.

OBJECTIVE: To assess the effectiveness of a muscle protocol to treat patients diagnosed with neuraxial low back pain (LBP) before and after invasive treatments. DESIGN: Patients with chronic (>6 months) LBP-postinvasive treatment and pre-spine surgery-were assessed and treated. An electrical device rather than palpation was used to determine muscle(s) as possible sources of pain. Patients testing positive for muscle pain were treated with a comprehensive protocol and were followed for >3 months to determine the effect of treatment on pain severity and interference in function. RESULTS: Study 1: In 56 (postinvasive treatment) patients who had failed back surgery, epidural steroid injections, facet blocks, and/or trigger point injections, mean Brief Pain Inventory (BPI) pain severity dropped from 5.54 at baseline to 3.96 (P < 0.001) at a median follow-up of 77 weeks; mean BPI interference dropped from 6.09 to 3.4 (P < 0.001). Fifty-two percent of respondents reported over 50% relief. Study 2: Three of seven patients originally scheduled for spine surgery completed a substantial part of the muscle protocol, canceled their surgeries, and obtained significant relief at the 16-19 month follow-up point. CONCLUSION: In patients thought to have neuraxial pain, identification and treatment of painful muscles had statistically significant long-lasting and clinically meaningful reductions in pain and improvement in function. Muscle and tendon attachments may be an important and treatable source of pain in patients diagnosed with pre and postsurgical neuraxial pain.

Burden of illness and treatment patterns for patients with fibromyalgia.

OBJECTIVE: This study was designed to describe burden of illness and treatment patterns, and to examine the patient, physician, and care factors associated with the treatment choices of individuals receiving new prescriptions for fibromyalgia (FM). DESIGN: This is a baseline assessment of the Real-World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS), a prospective observational study. Baseline data (including a physician survey, a patient visit form, and computer-assisted telephone interviews) were collected from July 2008 through May 2010 in 58 care settings in the United States, including Puerto Rico. RESULTS: Patients (N = 1,700) were mostly female (94.6%) and white (82.9%). Mean age was 50.4 years and mean duration of illness was 5.6 years. Mean Fibromyalgia Impact Questionnaire total score was 54.4 (range 0-80), and Brief Pain Inventory average pain severity level was 5.5 (range 0-10). Patients reported high annual health care use and numerous work limitations related to FM. Patients were taking 182 unique types of medications prescribed for FM, including duloxetine (26.8%), nonsteroidal anti-inflammatory drugs (26.6%), pregabalin (24.5%), opioids (24.2%), tramadol (15.3%), benzodiazepines (15.2%), cyclobenzaprine (12.9%), milnacipran (8.9%), and others. Most patients took more than one medication concurrently (77.8%). Type of current medications used was most strongly associated with medication history and physician specialty. CONCLUSIONS: Burden of illness was high for patients with FM, and treatment patterns were highly variable. Importantly, the treatments with the most evidence to support their use were not always the most frequently chosen.

Comprehensive chronic pain management: improving physical and psychological function (CME multimedia activity).

As shown in this CME online activity (www.cmeaccess.com/AJM/ChronicPain02), chronic, non-cancer pain can arise from a variety of etiologies and can be broadly classified based on its underlying mechanism as nociceptive, inflammatory, neuropathic, or central, with some patients having pain arising from a combination of mechanisms. Chronic pain assessment and treatment involves evaluating not only its biological aspects, but also psychological and sociocultural factors. Beyond neural mechanisms, a patient's perception of chronic pain can be influenced by comorbid mood disorders, such as depression and anxiety; cognitive and affective traits, such as catastrophizing and fear-avoidance; environmental stressors, family relationships, social support, and cultural beliefs. Based on this biopsychosocial model, a multidisciplinary approach to management incorporates pharmacotherapy (opioid, nonopioid, and centrally-acting analgesics, and pain adjuvant medications) with nonpharmacologic physical rehabilitation and psychological and behavioral therapies to address the multifactorial causes of chronic pain, which in turn leads to improvement of physical and psychological function.

Managing chronic pain with nonopioid analgesics: a multidisciplinary consult.

As detailed in this online CME activity (www.cmeaccess.com/AJM/ChronicPain04), determining pain mechanism is an important aspect guiding treatment selection for chronic musculoskeletal pain states. Although broad classifications provide a framework, any combination of mechanisms may be present in a chronic pain patient, and there is growing evidence that pain states generally considered nociceptive may also involve elements of augmented central nervous system pain processing. Nonopioid analgesics, including serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and alpha-2-delta ligand anticonvulsants, are the treatments of choice for fibromyalgia and other central neuropathic pain states. Additionally, studies have now shown that certain SNRIs can be effective in treating "classic" nociceptive pain states, such as osteoarthritis, and also are effective for low back pain. In addition to considering biological mechanisms, chronic pain management also involves recognizing and evaluating the contribution of psychological and sociocultural factors that can influence pain chronicity and patient prognosis. A multimodal/multidisciplinary approach incorporating pharmacologic and nonpharmacologic therapy into a program that includes more than 1 discipline is important to improve outcomes in patients with chronic pain.

Clinical overview of fibromyalgia.

Fibromyalgia (FM) is a complex disorder that affects up to 5% of the general population worldwide, more frequently in women than in men. In addition to chronic widespread pain, patients with FM usually experience other characteristic symptoms, including fatigue, disturbed sleep, stiffness, reduced functioning, dyscognition, and depressed mood. Many patients also have comorbid conditions such as depression, irritable bowel syndrome, temporomandibular disorder, or migraine. Although the etiology of FM remains unclear, evidence suggests that biologic, genetic, and environmental factors are involved. The variability of symptoms and the frequency of comorbidities among patients with FM make this a difficult disorder to diagnose. Diagnosis may be further complicated by the stigmatization of this disorder among treatment providers, the health insurance industry, and the general population. Treating chronic pain disorders such as FM can be time consuming and costly, and other issues such as polypharmacy, treatment adherence, and access to treatment often need to be addressed. The aim of this article is to provide physicians with a general overview of FM, including a brief review of the pathophysiology that explains the biologic and genetic bases of this disorder. Also included is a synopsis of new diagnostic criteria and other useful diagnostic tools and a discussion of various treatment challenges and strategies.

The science of fibromyalgia.

Fibromyalgia (FM) is a common chronic widespread pain disorder. Our understanding of FM has increased substantially in recent years with extensive research suggesting a neurogenic origin for the most prominent symptom of FM, chronic widespread pain. Neurochemical imbalances in the central nervous system are associated with central amplification of pain perception characterized by allodynia (a heightened sensitivity to stimuli that are not normally painful) and hyperalgesia (an increased response to painful stimuli). Despite this increased awareness and understanding, FM remains undiagnosed in an estimated 75% of people with the disorder. Clinicians could more effectively diagnose and manage FM if they better understood its underlying mechanisms. Fibromyalgia is a disorder of pain processing. Evidence suggests that both the ascending and descending pain pathways operate abnormally, resulting in central amplification of pain signals, analogous to the "volume control setting" being turned up too high. Patients with FM also exhibit changes in the levels of neurotransmitters that cause augmented central nervous system pain processing; levels of several neurotransmitters that facilitate pain transmission are elevated in the cerebrospinal fluid and brain, and levels of several neurotransmitters known to inhibit pain transmission are decreased. Pharmacological agents that act centrally in ascending and/or descending pain processing pathways, such as medications with approved indications for FM, are effective in many patients with FM as well as other conditions involving central pain amplification. Research is ongoing to determine the role of analogous central nervous system factors in the other cardinal symptoms of FM, such as fatigue, nonrestorative sleep, and cognitive dysfunction.

Improving the recognition and diagnosis of fibromyalgia.

Fibromyalgia (FM) is a chronic widespread pain disorder often seen in primary care practices. Advances in the understanding of FM pathophysiology and clinical presentation have improved the recognition and diagnosis of FM in clinical practice. Fibromyalgia is a clinical diagnosis based on signs and symptoms and is appropriate for primary care practitioners to make. The hallmark symptoms used to identify FM are chronic widespread pain, fatigue, and sleep disturbances. Awareness of common mimics of FM and comorbid disorders will increase confidence in establishing a diagnosis of FM.

Acute back pain: benefits and risks of current treatments.

OBJECTIVE: To review the efficacy and safety of current treatments for acute low back pain. RESEARCH DESIGN AND METHODS: PubMed was searched for clinical trials in which the words, acute, back, and pain all appeared in the study summary. The search was from the earliest references included in this database (1949) until 1 May 2009. This resulted in retrieval of 129 papers. Review of study summaries indicated that 36 provided information about either a topical treatment or oral therapy for acute low back pain. In addition, studies included as part of the evidence base for the Evidence Review of American Pain Society/American Academy of Pain Medicine Evidence Review for Evaluation and Management of Low Back Pain were reviewed. RESULTS: Recommended topical and systemic pharmacologic treatments for acute low back pain include application of superficial heat, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), skeletal muscle relaxants/benzodiazepines, and opioids including tramadol. Only a small number of studies compared different approaches to treatment of acute back pain and most failed to demonstrate significant differences among treatments. Available results support the view that both NSAIDs and low-level continuous heat treatment are more effective than acetaminophen and that heat treatment is also significantly more effective than ibuprofen. A potential limitation of this study is that information from trials published in journals not included in PubMed or reported only at meetings and not yet published was not included. CONCLUSIONS: A wide range of treatments is currently recommended for the management of patients with acute back pain and all are supported by results from controlled clinical trials.

Key patient assessment tools and treatment strategies for pain management.

National survey data indicate that more than 25% of American adults suffer from pain that lasts for more than 24 hours in duration. Chronic pain can have a devastating impact on an individual's relationships, daily functioning, and employment. Although the treatment of pain is something that clinicians face every day, providing optimal care for these patients can be difficult. Many clinicians feel that managing side effects, identifying and managing potential drug abusers, and navigating regulatory and legal issues can make pain management a complicated undertaking. This review discusses key patient assessment and treatment strategy tools, together with common medico-legal concerns to assist clinicians in more effectively managing their patients' pain.

Cannabinoids:their role in pain and palliation.

Controversy is associated with the issue of cannabis and cannabinoids in clinical care in the United States. Recent research has demonstrated the underlying mechanisms of cannabinoid analgesia via endocannabinoids, an endogenous system of retrograde neuromodulatory messengers that work in tandem with endogenous opioids. Additional receptor and non-receptor mechanisms of cannabinoid drugs have pertinent activity, including anti-carcinogenesis and neuroprotection, that may be of key importance in aging and terminal patient populations. The results of clinical trials with synthetic and plant-based cannabinoids suggest that the role of formulation and delivery system is critical in optimizing the risk-benefit profile of cannabinoid products. Synergy between opioids and cannabinoids may produce opioid-sparing effects, as well as extend the duration of analgesia and reduce opioid tolerance and dependence. This article reviews the mechanism of action of cannabinoids, examines marketed agents and those in clinical trials, and addresses their role in treatment of chronic pain, cancer, neurodegenerative diseases, and HIV/ AIDS. The ability of cannabinoid medicines to treat pain, associated sleep disorders, appetite loss, muscle spasm and a wide variety of other symptoms suggests that such agents may in the future play an important role in palliative care.

American pain society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force.

BACKGROUND: The American Pain Society (APS) set out to revise and expand its 1995 Quality Improvement Guidelines for the Treatment of Acute Pain and Cancer Pain and to facilitate improvements in the quality of pain management in all care settings. METHODS: Eleven multidisciplinary members of the APS with expertise in quality improvement or measurement participated in the update. Five experts from organizations that focus on health care quality reviewed the final recommendations. MEDLINE and Cumulative Index to Nursing and Allied Health Literature databases were searched (1994-2004) to identify articles on pain quality measurement and quality improvement published after the development of the 1995 guidelines. The APS task force revised and expanded recommendations on the basis of the systematic review of published studies. The more than 3000 members of the APS were invited to provide input, and the 5 experts provided additional comments. The task force synthesized reviewers' comments into the final set of recommendations. RESULTS: The recommendations specify that all care settings formulate structured, multilevel systems approaches (sensitive to the type of pain, population served, and setting of care) that ensure prompt recognition and treatment of pain, involvement of patients and families in the pain management plan, improved treatment patterns, regular reassessment and adjustment of the pain management plan as needed, and measurement of processes and outcomes of pain management. CONCLUSION: Efforts to improve the quality of pain management must move beyond assessment and communication of pain to implementation and evaluation of improvements in pain treatment that are timely, safe, evidence based, and multimodal.