Validating an algorithm for multiple myeloma based on administrative data using a SEER tumor registry and medical record review.

PURPOSE: Large numbers of multiple myeloma patients can be studied in real-world clinical settings using administrative databases. The validity of these studies is contingent upon accurate case identification. Our objective was to develop and evaluate algorithms to use with administrative data to identify multiple myeloma cases. METHODS: Patients aged ≥18 years with ≥1 International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for multiple myeloma (203.0x) were identified at two study sites. At site 1, several algorithms were developed and validated by comparing results to tumor registry cases. An algorithm with a reasonable positive predictive value (PPV) (0.81) and sensitivity (0.73) was selected and then validated at site 2 where results were compared with medical chart data. The algorithm required that ICD-9-CM codes 203.0x occur before and after the diagnostic procedure codes for multiple myeloma. RESULTS: At site 1, we identified 1432 patients. The PPVs of algorithms tested ranged from 0.54 to 0.88. Sensitivities ranged from 0.30 to 0.88. At site 2, a random sample (n = 400) was selected from 3866 patients, and medical charts were reviewed by a clinician for 105 patients. Algorithm PPV was 0.86 (95% CI, 0.79-0.92). CONCLUSIONS: We identified cases of multiple myeloma with adequate validity for claims database analyses. At least two ICD-9-CM diagnosis codes 203.0x preceding diagnostic procedure codes for multiple myeloma followed by ICD-9-CM codes within a specific time window after diagnostic procedure codes were required to achieve reasonable algorithm performance.

Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention.

INTRODUCTION: The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages. METHODS: Results from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category. RESULTS: In total, 73,645 patients were enrolled into the REMS programs for lenalidomide and thalidomide and completed mandatory surveys prior to medication dispense. Of these, 2790 (3.8%) completed an additional voluntary survey. Among voluntary survey participants, for all patient pregnancy risk categories, reported compliance with birth control requirements was above 90% when starting therapy and at follow-up. At the beginning of therapy, complete compliance was 96.3%; 3 months later it was 96.4%. Patient understanding of safe-use messages was very high in all pregnancy risk groups, notably for messages repeated at each physician visit. Overall, 98.2% of patients knew that lenalidomide and thalidomide could cause birth defects, which is part of the repeated educational messaging. In contrast, 87.1% recalled that unused product should be returned to their healthcare professional, which is not included in repeated messaging. CONCLUSION: The lenalidomide and thalidomide REMS programs enhance patient understanding of safe-use messages, resulting in high levels of compliance with the birth control precautions essential to prevent fetal exposure to these known and potential human teratogens. Overall compliance was maintained after 3 months of follow-up and throughout therapy.

New cancers after autotransplantations for multiple myeloma.

We describe baseline incidence and risk factors for new cancers in 4161 persons receiving autotransplants for multiple myeloma in the United States from 1990 to 2010. Observed incidence of invasive new cancers was compared with expected incidence relative to the US population. The cohort represented 13,387 person-years at-risk. In total, 163 new cancers were observed, for a crude incidence rate of 1.2 new cancers per 100 person-years and cumulative incidences of 2.6% (95% confidence interval [CI], 2.09 to 3.17), 4.2% (95% CI, 3.49 to 5.00), and 6.1% (95% CI, 5.08 to 7.24) at 3, 5, and 7 years, respectively. The incidence of new cancers in the autotransplantation cohort was similar to age-, race-, and gender-adjusted comparison subjects with an observed/expected (O/E) ratio of 1.00 (99% CI, .81 to 1.22). However, acute myeloid leukemia and melanoma were observed at higher than expected rates with O/E ratios of 5.19 (99% CI, 1.67 to 12.04; P = .0004), and 3.58 (99% CI, 1.82 to 6.29; P < .0001), respectively. Obesity, older age, and male gender were associated with increased risks of new cancers in multivariate analyses. This large data set provides a baseline for comparison and defines the histologic type specific risk for new cancers in patients with MM receiving postautotransplantation therapies, such as maintenance.

Health-related quality of life outcomes of lenalidomide in transfusion-dependent patients with Low- or Intermediate-1-risk myelodysplastic syndromes with a chromosome 5q deletion: results from a randomized clinical trial.

We report health-related quality of life (HRQL) outcomes assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) among 167 RBC transfusion-dependent patients with IPSS Low-/Intermediate-1-risk del5q31 MDS treated with lenalidomide versus placebo in a randomized phase 3 clinical trial, MDS-004. Mean baseline to 12 week changes in FACT-An Total scores improved following treatment with lenalidomide 5 and 10mg (+5.7 and +5.7, respectively) versus placebo (-2.8) (both p<0.05). Clinically important changes in HRQL from baseline were observed at weeks 12, 24, 36, and 48 among RBC-TI≥26 week responders in both treatment groups. Lenalidomide treatment may be effective in improving HRQL outcomes.

A review of second primary malignancy in patients with relapsed or refractory multiple myeloma treated with lenalidomide.

In a retrospective pooled analysis of 11 clinical trials of lenalidomide-based therapy for relapsed/refractory multiple myeloma (MM; N = 3846), the overall incidence rate (IR, events per 100 patient-years) of second primary malignancies (SPMs) was 3.62. IR of invasive (hematologic and solid tumor) SPMs was 2.08, consistent with the background incidence of developing cancer. In a separate analysis of pooled data from pivotal phase 3 trials of relapsed or refractory MM (N = 703), the overall IR of SPMs was 3.98 (95% confidence interval [CI], 2.51-6.31) with lenalidomide/dexamethasone and 1.38 (95% CI, 0.44-4.27) with placebo/dexamethasone; IRs of nonmelanoma skin cancers were 2.40 (95% CI, 1.33-4.33) and 0.91 (95% CI, 0.23-3.66), respectively; IRs of invasive SPMs were 1.71 (95% CI, 0.86-3.43) and 0.91 (95% CI, 0.23-3.66), respectively. The risk of SPMs must be taken into account before initiating lenalidomide treatment. In the context of the observed survival benefit in relapsed or refractory MM patients, the benefit/risk profile of lenalidomide/dexamethasone remains positive.

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

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 14034 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 $10911 (SD=$16075). RA patient annual expenditures were similar to FM: $10716 (SD= $16860). Annual expenditures were almost double in patients with FM+RA ($19395, SD= $25440). A greater proportion of patients with FM had any short-term disability days than those with RA (20 vs. 15%); and a greater proportion of patients with RA had any absence days (65 vs. 80%). Mean costs for absence from work and short-term disability in the FM and RA groups were substantial and similar. The FM+RA group was of insufficient sample size to report on work loss. LIMITATIONS: The availability of newer and more expensive FDA-approved medications since 2004 is not reflected in our findings. This analysis was restricted to commercially insured patients and therefore may not be generalizable to the entire U.S. population. CONCLUSIONS: The burden of illness in FM is substantial and comparable to RA. Patients with FM incurred direct costs approximately equal to RA patients. Patients with FM had more ED, physician, and physical therapy visits than RA patients. Patients in both groups had several comorbidities. Patients with FM+RA incurred direct costs almost double those of the patients with either diagnosis alone. FM and RA patients incurred similar overall absence and short-term disability costs.

Venous thromboembolism in myelodysplastic syndrome patients receiving lenalidomide: results from postmarketing surveillance and data mining techniques.

BACKGROUND AND OBJECTIVES: Multiple myeloma treatment with lenalidomide-based regimens is associated with risk of venous thromboembolism (VTE), particularly during concomitant use with erythropoiesis-stimulating agents (ESAs). The risk of VTE in myelodysplastic syndrome (MDS) patients treated with lenalidomide is not well characterized and the background risk in untreated patients is not known. This study set out to determine the reporting rate of VTE in MDS patients on lenalidomide in the two years of postmarketing experience in the US, and to investigate whether there is a disproportional signal of VTE in MDS patients on lenalidomide by screening the US FDA Adverse Event Reporting System (AERS) safety database. METHODS: The MDS population exposed to lenalidomide was obtained from RevAssist, the company's proprietary restrictive distribution programme. VTE reports were identified from the company's postmarketing surveillance safety database. The FDA AERS database was used for disproportionality analysis, and signal scores computed using three algorithms: multi-item gamma Poisson shrinker (MGPS), proportional reporting ratio (PRR), and reporting odds ratios (ROR). RESULTS: A total of 7764 MDS patients were prescribed lenalidomide during the first two years of commercial use in the US. VTE representing deep vein thrombosis and pulmonary embolism was reported in 41 patients, a reporting rate of 0.53%. The computed signal scores did not exceed the statistical threshold for identification of a significant disproportional signal for VTE in MDS reports involving use of lenalidomide without concomitant use of ESAs. However, a disproportional signal of VTE was detected in MDS reports where lenalidomide was concurrently used with ESAs. CONCLUSION: The VTE reporting rate for MDS patients receiving lenalidomide during the first two years of postmarketing exposure was low (0.53%). Disproportionality analysis demonstrated a statistically meaningful association of VTE with lenalidomide concomitantly used with ESAs in MDS patients, but the association was not statistically significant when lenalidomide was used in the absence of ESAs.

Painful diabetic peripheral neuropathy in a managed care setting: patient identification, prevalence estimates, and pharmacy utilization patterns.

The objectives of this study were to validate an algorithm for identifying patients with painful diabetic peripheral neuropathy (pDPN) and demonstrate its practical applications. Using the Kaiser Permanente Colorado Diabetes Registry, an algorithm was developed with selected ICD-9 diagnosis codes combined with automated pharmacy data for medications prescribed for pDPN symptoms. Medical records were reviewed to confirm pDPN presence and to inform algorithm refinement. Prevalence was estimated with a numerator of members with diabetes who had inclusion but no exclusion codes in 2003 (Method 1) and with a numerator of diabetes patients with inclusion codes between 1998 and 2003 who had no subsequent exclusion codes and who remained members in 2003 (Method 2); the denominator was all members with diabetes in 2003. Medication utilization was compared between patients with and without pDPN. A total of 19,577 members with diabetes were identified; 2612 met initial inclusion criteria. Medical record review (n = 298) demonstrated sensitivity of 94%, specificity of 55%, and positive predictive value (PPV) of 64%. Inclusion criteria were modified and pharmacy data eliminated. The revised algorithm identified 1754 additional patients meeting inclusion criteria. Medical record review (n = 190) demonstrated sensitivity of 99%, specificity of 49%, and PPV of 79%. Using the validated algorithm, pDPN prevalence was 113 (Method 1) and 208 (Method 2) per 1000 persons with diabetes. Significant differences were observed in medication prescriptions between patients with and without pDPN. Estimated pDPN prevalence among persons with diabetes was 11%-21% and pDPN patients had greater utilization of selected medications than those without pDPN. Identifying patients with pDPN is a fundamental step for improving disease management and understanding the economic impact of pDPN.

Health-related quality of life and utilities in primary-care patients with generalized anxiety disorder.

BACKGROUND: Generalized anxiety disorder (GAD) is prevalent and significantly impacts patient health-related quality of life (HRQL) and disability. PURPOSE: This study evaluated the effect of GAD and anxiety symptom severity on the HRQL of primary-care patients with GAD. METHODS: Patients 18 years or older with GAD were recruited from an integrated health care delivery system. Clinical assessments included the Hamilton Anxiety Rating Scale (HAM-A), GAD Questionnaire-IV (GAD-Q-IV), and the Patient Health Questionnaire depression module (PHQ). HRQL was assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), Sheehan Disability Scale (SDS), SF-12 Health Survey (SF-6D), and the Health Utilities Index (HUI2, HUI3). RESULTS: The sample included 297 patients, 72% women with mean +/- standard deviation (SD) age of 47.6 +/- 13.7 years. At baseline, the mean HAM-A score was 16.8 +/- 7.6 (suggesting the presence of moderate anxiety symptoms). Anxiety and depression symptoms were significantly correlated with mental component summary (MCS), Q-LES-Q-SF, SDS, SF-6D, HUI2, and HUI3 scores (all P < 0.001). The mean HRQL and all of the preference-based measures varied significantly by anxiety severity groups (all P < 0.001). Anxiety and depression symptoms significantly predicted HRQL and preference-based scores (R(2) values ranged from 0.22 to 0.57). CONCLUSIONS: Anxiety symptoms reported by GAD patients resulted in significant impairment to HRQL and functional outcomes.

RevAssist: a comprehensive risk minimization programme for preventing fetal exposure to lenalidomide.

Lenalidomide (Revlimid) is an immunomodulatory drug and an analogue of thalidomide, a known teratogen. To prevent fetal exposure, in the US lenalidomide is available only under a special restricted distribution programme called RevAssist. Under this risk minimization programme, only prescribers and contract pharmacies registered with the programme are able to prescribe and dispense the product. Patients must be advised of, agree to and comply with the requirements of the RevAssist programme in order to receive lenalidomide through a registered prescriber. A total of 15 584 patients were registered in the RevAssist programme during the first year lenalidomide was on the market. There were four reports of false-positive beta-human chorionic gonadotrophin measurements in patients aged 43-57 years. Mandatory patient and prescriber surveys have shown discrepant responses that were resolved by risk management intervention specialists 99% of the time. The voluntary patient surveys have shown understanding of the risks of lenalidomide use and of behaviours necessary to minimize risks in >95% of females of childbearing potential and adult males. To date, there have been no reports of pregnancy in female patients or female partners of male patients. The pharmacy audit findings showed compliance with RevAssist was high. Although RevAssist is labour-intensive, time-consuming and costly, it continues to be effective in preventing fetal exposure to lenalidomide.

Reliability, validity, and responsiveness of the daily sleep interference scale among diabetic peripheral neuropathy and postherpetic neuralgia patients.

To evaluate the psychometric characteristics of the Daily Sleep Interference Scale (DSIS) in patients with painful diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN), a post hoc secondary analysis of data from eight randomized clinical trials (four DPN and four PHN) was performed. Data were pooled within patient populations when assessment weeks were the same. The DSIS was completed by 1,124 DPN and 1,034 PHN patients. Patient-reported outcomes, including a Daily Pain Diary, the Short-Form McGill Pain Questionnaire, SF-36 Health Survey, Profile of Mood States, MOS-Sleep Scale (MOS-SS), EQ-5D, and Patient Global Impression of Change, were used to validate the DSIS. Test-retest reliability was high for both samples (intraclass correlation coefficient>0.90). The DSIS showed good construct validity, with moderate to high correlations between the DSIS and weekly mean pain scores (r=0.48-0.80), MOS-SS sleep disturbance subscale (r=0.45-0.64), MPQ-SF Pain Experience (r=0.37-0.61), and VAS (r=0.42-0.72). The DSIS showed good discriminant validity in both groups; high and low MOS-SS sleep disturbance groups had significantly different DSIS scores (P<0.001). DPN patients who improved minimally on the Patient Global Impression of Change and in pain scores improved 1.5-2 DSIS points on average; for PHN, patient scores improved an average of 1-2 points. The DSIS demonstrated robust test-retest reliability, good construct and discriminant validity and responsiveness in painful DPN and PHN patients. A 1-2 point change on the DSIS might be interpreted as an important difference.

A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions.

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.

Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

UNLABELLED: A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.

Cost-effectiveness of add-on therapy with pregabalin in patients with refractory partial epilepsy.

PURPOSE: To estimate the cost-effectiveness of pregabalin as add-on therapy in patients with refractory partial epilepsy. METHODS: We developed a model to estimate clinical and economic outcomes over 1 year in a hypothetical cohort of patients with refractory partial epilepsy assumed alternatively to receive add-on therapy with pregabalin (300 mg/day) or no add-on therapy. For each patient in the model, we estimated the occurrence of seizure and side effects, using techniques of stochastic simulation. We assigned health-state utilities to each day of follow-up based on whether or not seizure or side effects were predicted to occur. Patients could discontinue therapy due to lack of efficacy or side effects. Outcomes included expected numbers of days without seizure ("seizure-free [SF] days"), quality-adjusted life-years (QALYs), and costs of therapy. Cost-effectiveness was assessed alternatively in terms of incremental cost per SF day gained and incremental cost per QALY gained. RESULTS: Add-on therapy with pregabalin was estimated to result in an average gain of 23.8 SF days over one year; the estimated additional cost of therapy was $678. Incremental cost (mean, 95% CI) per SF day gained was $28.45 ($27.25, $29.44); corresponding estimates of incremental cost per QALY gained were $52,893 ($49,249, $56,983). CONCLUSIONS: In patients with refractory partial epilepsy, the cost-effectiveness of pregabalin 300 mg/day compares favorably with published estimates of cost-effectiveness for other add-on antiepileptic drugs.

The impact of seizures and adverse effects on global health ratings.

This study was undertaken to explore the perceived impact of having a seizure (SZ) compared with having an adverse effect (AE). Patients (N=201) with partial-onset epilepsy taking two or more antiepileptic drugs (AEDs) rated their health state from 0 to100 based on their health today, hypothetical health if experiencing a SZ today, and hypothetical health if experiencing an AE today. Overall health status ratings (HLTH) declined as SZ frequency increased (P=0.01). Perceived decrements in HLTH with SZs were greatest for patients with the least frequent SZs (P=0.001) and the most recent SZs (P=0.004). Perceived decrements in HLTH with SZs compared with AEs (SZ-AE) differed across SZ recency groups (P<0.05 except for muscle incoordination and weakness). Patients with the more remote SZs were most concerned with SZ control; patients with more recent SZs were more sensitive to AED side effects. These data provide insight into the risk-benefit concerns of patients at equipoise when addressing the efficacy and AEs of AEDs.

Lost productive time and costs due to diabetes and diabetic neuropathic pain in the US workforce.

OBJECTIVE: Estimate the impact of diabetes and neuropathic pain on the US workforce. METHODS: Data on lost productive time (LPT) was collected by telephone interview in a random sample of the US population (N=36,634). Of 19,075 occupation-eligible working adults included in the analysis, 1003 reported a physician diagnosis of diabetes; 38% of these reported numbness or tingling in feet or hands due to diabetes (symptom group). We compared diabetes respondents with and without symptoms to other respondents for LPT and related cost. RESULTS: Health-related LPT was 18% higher in the symptom (P<0.05) and 5% higher in the non-symptom (P<0.05) groups versus for those without diabetes. The symptom group lost 1.4 hours of work per week more than the non-symptom group (P<0.05). CONCLUSIONS: Workers who have diabetes with neuropathic symptoms lose the equivalent of $3.65 billion/yr in health-related LPT.

Burden of illness in painful diabetic peripheral neuropathy: the patients' perspectives.

UNLABELLED: Our goal was to assess the patient-level burden among subjects with painful diabetic peripheral neuropathy (DPN). Community-based physicians recruited patients with painful DPN (N = 255) between April and October 2003. Patients completed a survey on pain experience (Brief Pain Inventory-DPN [BPI-DPN]), health status (EuroQoL [EQ-5D]), healthcare utilization (consults, prescription [Rx], and over-the-counter [OTC] medications), and work productivity/functioning. Patients were 61 +/- 12.8 years old and had diabetes for 12 +/- 10.3 years and painful DPN for 6.4 +/- 6.4 years; 25.5 and 62.7% had other neuropathic and musculoskeletal pain conditions. Average and worst pain scores (BPI-DPN, 0-10 scales) were 5.0 +/- 2.5 and 5.6 +/- 2.8. The mean EQ-5D utility was .5 +/- .3 (range = -.594-1). A majority (87.4%) took pain medications (Rx/OTC) in the preceding week: an average of 3.8 +/- 3.9 Rx and 2.1 +/- 1.3 OTC medications. Nearly half (46.7%) received NSAIDs. Other frequently reported medications were short/long-acting opioids (43.1%), anticonvulsants (27.1%), selective serotonin reuptake inhibitors/selective norepinephrine reuptake inhibitors (18%), and tricyclic antidepressants (11.4%). During the preceding 3 months, 59.6% had >or=2 health professional consults; 59% reported decreased home productivity; 85.5% reported activity limitations; and 64.4% of patients who worked (N = 73) reported missing work/decreased work productivity due to painful DPN. Our results underscore a substantial patient-level burden among subjects with painful DPN. PERSPECTIVE: Information on the patient-level burden among painful DPN sufferers in the U.S. was previously lacking. Our results suggest that this burden is significant, evidenced by moderate-to-high pain levels, polypharmacy, health resource use, and work/activity limitations. Results also suggest suboptimal pain management and low levels of satisfaction with treatments.

Sleep impairment in patients with painful diabetic peripheral neuropathy.

OBJECTIVE: This 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. METHODS: This 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). RESULTS: Patients 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. DISCUSSION: Painful 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.

Sleep disturbances reported by refractory partial-onset epilepsy patients receiving polytherapy.

PURPOSE: Although sleep disturbances are common in epilepsy, few studies examined the prevalence and impact of sleep disturbance in epilepsy patients. This study investigates these in a cross-sectional survey. METHODS: We surveyed 201 adult partial-onset epilepsy patients taking stable regimens of two or more antiepileptic medications. Community-based U.S. neurologists recorded patient demographic and clinical information. Patients completed the Medical Outcomes Study (MOS) Sleep Scale, the Quality of Life in Epilepsy-10 instrument (QOLIE-10), and the EuroQol-5D (EQ-5D). We evaluated the associations of sleep with health-related quality of life and clinical and demographic characteristics by using correlation coefficients and analysis of variance. RESULTS: Mean (SD) age was 44.2 (12.5); 34% of patients had diagnosed sleep disturbances; 10% received prescription sleep medications. Patients with sleep disturbance reported poorer mean QOLIE-10 (55.2 vs. 63.7; p = 0.006) and EQ-5D (0.49 vs. 0.71; p < 0.001) scores relative to those without sleep disturbances. The mean (SD) MOS Sleep Problems Index score was 36.2 (20.8), worse than the general population mean of 26. Patients with physician-reported anxiety or depression had more sleep problems than did those without these comorbidities. Higher Sleep Problems Index scores were significantly (p < 0.001) correlated with poorer QOLIE-10 (r=-0.49) and EQ-5D (r=-0.56) scores. Patients experiencing a seizure within the past week reported higher MOS Sleep Problems Index scores than did those with a less-recent seizure (41.5 vs. 32.8; p = 0.003). CONCLUSIONS: Diagnosed and self-reported sleep disturbances in patients with partial-onset epilepsy are frequently overlooked, but are negatively associated with everyday functioning and well-being, and therefore contribute significantly to the burden of epilepsy.