Nancy Brandenburg

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

AbstractObjective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of d

Core outcome domains for chronic pain clinical trials

&NA; Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

Chronic spinal pain and physical-mental comorbidity in the United States: Results from the national comorbidity survey replication

This paper investigates comorbidity between chronic back and neck pain and other physical and mental disorders in the US population, and assesses the contributions of chronic spinal pain and comorbid conditions to role disability. A probability sample of US adults (n=5692) was interviewed. Chronic spinal pain, other chronic pain conditions and selected chronic physical conditions were ascertained by self‐report. Mood, anxiety and substance use disorders were ascertained with the Composite International Diagnostic Interview (CIDI). Role disability was assessed with questions about days out of role and with impaired role functioning. The 1 year prevalence of chronic spinal pain was 19.0%. The vast majority (87.1%) of people with chronic spinal pain reported at least one other comorbid condition, including other chronic pain conditions (68.6%), chronic physical conditions (55.3%), and mental disorders (35.0%). Anxiety disorders showed as strong an association with chronic spinal pain as did mood disorders. Common conditions not significantly comorbid with chronic spinal pain were diabetes, heart disease, cancer, and drug abuse. Chronic spinal pain was significantly associated with role disability after controlling for demographic variables and for comorbidities. However, comorbid conditions explained about one‐third of the gross association of chronic spinal pain with role disability. We conclude that chronic spinal pain is highly comorbid with other pain conditions, chronic diseases, and mental disorders, and that comorbidity plays a significant role in role disability associated with chronic spinal pain. The societal burdens of chronic spinal pain need to be understood and managed within the context of comorbid conditions.

Rethinking the duration requirement for generalized anxiety disorder: evidence from the National Comorbidity Survey Replication.

BACKGROUND The proposed revisions of the ICD and DSM diagnostic systems have led to increased interest in evaluation of diagnostic criteria. This report focuses on the DSM-IV requirement that episodes of generalized anxiety disorder (GAD) must persist for at least 6 months. Community epidemiological data are used to study the implications of changing this requirement in the range 1-12 months for estimates of prevalence, onset, course, impairment, co-morbidity, associations with parental GAD, and sociodemographic correlates. METHOD Data come from the US National Comorbidity Survey Replication (NCS-R), a US household survey carried out during 2001-2003. Version 3.0 of the WHO Composite International Diagnostic Interview (WMH-CIDI) was used to assess DSM-IV anxiety disorders, mood disorders, substance disorders, and impulse-control disorders. RESULTS Lifetime, 12-month, and 30-day prevalence estimates of DSM-IV GAD changed from 6.1%, 2.9%, and 1.8% to 4.2-12.7%, 2.2-5.5%, and 1.6-2.6% when the duration requirement was changed from 6 months to 1-12 months. Cases with episodes of 1-5 months did not differ greatly from those with episodes of > or = 6 months in onset, persistence, impairment, co-morbidity, parental GAD, or sociodemographic correlates. CONCLUSIONS A large number of people suffer from a GAD-like syndrome with episodes of < 6 months duration. Little basis for excluding these people from a diagnosis is found in the associations examined here.

A Review of the Epidemiology of Painful Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Less Commonly Studied Neuropathic Pain Conditions

▪ Abstract:  Although the burden of neuropathic pain is well‐recognized, the descriptive epidemiology of specific neuropathic pain conditions has not been well‐described. While painful diabetic peripheral neuropathy and postherpetic neuralgia have been widely evaluated, many other peripheral and central neuropathic pain syndromes have been less frequently studied. This review summarizes incidence and/or prevalence information about two relatively frequent neuropathic pain conditions—painful diabetic peripheral neuropathy and postherpetic neuralgia—and similarly summarizes the more limited epidemiologic information available for other peripheral and central neuropathic pain conditions. The data suggest that while our knowledge is still incomplete, the high frequency of several of these conditions in specific populations should be considered an important impetus for further studies designed to evaluate their contribution to the overall burden of neuropathic pain. ▪

Sleep impairment in patients with painful diabetic peripheral neuropathy.

ObjectiveThis study evaluated sleep impairment associated with painful diabetic peripheral neuropathy (DPN), a neuropathic pain condition. Sleep is of critical concern for DPN because sleep impairment and its comorbidities may influence type 2 diabetes progression. MethodsThis is a supplemental analysis of sleep data from a burden of illness study of patients with painful DPN (N=255, 61±12.8 y old, 51.4% women). Sleep was evaluated using the Medical Outcomes Study Sleep measure (MOS-Sleep). MOS-Sleep scores were compared with general population norms (N=1011), the MOS chronic disease sample (N=3445), and patients with postherpetic neuralgia (N=89). The MOS-Sleep Sleep Adequacy score was compared with data from the MOS diabetes subsample (N=590). ResultsPatients with painful DPN reported impaired sleep relative to the general population (P<0.001), the chronic disease sample (P<0.001), and postherpetic neuralgia patients (P<0.05). Self-rated MOS-Sleep Sleep Adequacy was significantly less for the painful DPN than for the diabetes sample (P<0.001), although self-reported hours of sleep were not significantly different. Multiple regression indicated that age, average daily pain, and anxiety and depression symptom levels were each significantly (P<0.01) associated with, and collectively accounted for, 47% of variance in the MOS-Sleep Sleep Problems Index. DiscussionPainful DPN is associated with considerable sleep impairment. Given the recognized association between sleep impairment, type 2 diabetes and metabolic and affective disturbance, and the known adverse impact of affective disturbance on diabetes self-care, addressing these features—pain, sleep, and affective disturbance—is an important aspect of care for patients with painful DPN.

Mental and Physical Comorbid Conditions and Days in Role Among Persons with Arthritis

Objective: To estimate the prevalence of comorbidity among people with arthritis in the US adult population and to determine the role of comorbidity in accounting for the association of arthritis with days out of role (a measure of inability to work or carry out normal activities). Methods: Data come from the National Comorbidity Survey Replication (NCS-R), a nationally representative household survey of 9,282 respondents ages 18 and older carried out in 2001 to 2003. Arthritis was assessed by self-report in a chronic-conditions checklist, along with a wide range of other physical conditions. Mental and substance use disorders were ascertained with the World Health Organization Composite International Diagnostic Interview (CIDI). Number of days out of role was assessed for the 30 days before the interview. Results: Arthritis was reported by 27.3% of respondents, 80.9% of whom also reported at least one other physical or mental disorder, including 45.6% with another chronic pain condition, 62.3% with another chronic physical condition, and 24.3% with a 12-month mental disorder. Arthritis was significantly associated with days out of role, but comorbidity explained more than half of this association. No significant interactions were found between arthritis and the other conditions in predicting days out of role. Conclusion: Comorbidity is the rule rather than the exception among people with arthritis. Comorbidity accounts for most of the days out of role associated with arthritis. The societal burden of arthritis needs to be understood and managed within the context of these comorbid conditions. NCS-R = National Comorbidity Survey Replication; WHO = World Health Organization; CIDI = Composite International Diagnostic Interview; WHO-DAS = WHO Disability Assessment Schedule; OR = odds ratio.

The economic burden of fibromyalgia: comparative analysis with rheumatoid arthritis*

ABSTRACT Objective: To quantify and compare direct costs, utilization, and the rate of comorbidities in a sample of patients with fibromyalgia (FM), a poorly understood illness associated with chronic widespread pain that is commonly treated by rheumatologists, to patients with rheumatoid arthritis (RA), a well studied rheumatologic illness associated with inflammatory joint pain. Patients with both illnesses were isolated and reported as a third group. A secondary analysis of work loss was performed for an employed subset of these patients. Research design and methods: Retrospective cohort analysis of Thomson Reuters MarketScan administrative healthcare claims and employer-collected absence and disability data for adult patients with a diagnosis of FM (ICD-9-CM 729.1) and/or RA (ICD-9-CM 714.0x,–714.3x) on at least one inpatient or two outpatient claims during 2001–2004. Main outcome measures: The 12-month healthcare utilization, expenditures, and rates of comorbidities were quantified for all study-eligible patients; absence and short-term disability days and costs were quantified for an employed subset. Results: The sample included 14 034 FM, 7965 RA, and 331 FM + RA patients. Patients with FM had a higher prevalence of several comorbidities and greater emergency department (ED) utilization than those with RA. Mean annual expenditures for FM patients were

Differentiating anxiety and depression symptoms in patients with partial epilepsy

10 911 (SD = 

Sleep Disturbances Reported by Refractory Partial-onset Epilepsy Patients Receiving Polytherapy

16 075). RA patient annual expenditures were similar to FM: