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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep.

Our goal was to evaluate pain severity, pain-related interference with function, sleep impairment, symptom levels of anxiety and depression, and quality of life among patients with painful diabetic peripheral neuropathy (DPN). Participants in a burden of illness survey (n = 255) completed the modified Brief Pain Inventory-DPN (BPI-DPN), MOS Sleep Scale, Hospital Anxiety and Depression Scale (HADS), Short Form Health Survey-12v2 (SF-12v2), and the EuroQoL (EQ-5D). Patients were 61 +/- 12.

Validation of a modified version of the Brief Pain Inventory for painful diabetic peripheral neuropathy.

Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions. This study evaluated the psychometric properties of a modified Brief Pain Inventory (BPI) for patients with painful diabetic peripheral neuropathy (BPI-DPN).

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.

Differentiating anxiety and depression symptoms in patients with partial epilepsy.

Anxiety and depression are separate psychiatric conditions that are often interrelated. This study examines whether they exist independently in this population of patients with partial epilepsy and if they affect all quality-of-life domains. Adult epilepsy patients taking two or more antiepileptic drugs completed a health status survey including demographic items, the Hospital Anxiety and Depression Scale, and the Quality of Life in Epilepsy-10 (QOLIE-10).