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Biomedical subjects

Richard B Lipton

Publications and source records attributed to Richard B Lipton.

At least 73 records · Page 4Linked to original sources

Pharmacy and medical claims data identified migraine sufferers with high specificity but modest sensitivity.

OBJECTIVE: Claims data are often used to identify and monitor individuals with particular conditions, but many health conditions are not easily recognizable from claims data alone. Patient characteristics routinely available in claims data were used to develop model-based claims signatures to identify migraineurs. STUDY DESIGN AND SETTING: A validated telephone interview was administered to 23,299 continuously enrolled managed care members aged 18-55 to identify 1,265 migraineurs and 1,178 controls. Responses were linked to medical and prescription claims. Claims variables were evaluated for sensitivity, specificity, and positive and negative predictive value in predicting migraine status. Regression models for predicting migraine status were developed. RESULTS: Regression-based claims signature models were successful in case-finding, as indicated by fairly sizable odds ratios (OR). In the full model (including demographic, medical, pharmacy, and comorbidity claims variables), a claim for a migraine drug, gender, and a claims-based headache diagnosis were strongly associated with migraine case status (OR=3.9, 3.2, and 3.0, respectively). CONCLUSION: Using either medical or pharmacy claims provided highly specific and moderately sensitive case-findings. Strategies that combined medical and pharmacy information improved sensitivity and may increase the usefulness of claims for identifying migraine and improving the quality of migraine care.

Adolescent↗

The medical care utilization and costs associated with migraine headache.

OBJECTIVE: To describe the medical care use and costs associated with migraine. DESIGN: Retrospective case-control design in which migraine case status was ascertained via validated telephone interview and linked with comprehensive claims data. Unadjusted and adjusted use and cost differences by migraine status were evaluated using exponential score tests and generalized estimating equations. SETTING AND PATIENTS: We interviewed 8,579 individuals to identify migraine cases (N = 1,265) and a random sample of nonmigraine controls (N = 1,178) among eligible health plan enrollees aged 18 to 55. MEASURES: Survey responses were used to categorize individuals meeting the International Headache Society's diagnostic criteria for migraine with or without aura as migraine cases and to collect information on comorbid psychiatric symptoms. Claims data were used to compile annual medical and pharmaceutical use and costs, presence of migraine diagnosis, and other diagnosed comorbidities. RESULTS: Interview-ascertained migraine cases used more outpatient visits (9.1 vs 6.8; P < .01), were more likely to be seen in the emergency department (20.7% vs 17.6%; P < .05), and were admitted to the hospital more (4.5% vs 2.8%; P < .05) compared to nonmigraine controls. Cases incurred significantly higher medical care costs ($2,761 vs $2,064; P < .01). Multivariable model results indicate that much of this increase in costs is due to the presence of major depressive symptoms as well as other diagnosed comorbidities that are more common among those with migraine. CONCLUSIONS: By combining validated telephone survey information to identify migraine cases and controls with comprehensive claims data, we found migraine cases incur higher medical care costs compared to controls. These increased costs are associated with the presence of psychiatric symptoms and other comorbidities.

Adult↗

Efficacy of diclofenac sodium softgel 100 mg with or without caffeine 100 mg in migraine without aura: a randomized, double-blind, crossover study.

OBJECTIVE: A phase II, randomized, double-blind, crossover study was designed to evaluate the efficacy of 100-mg diclofenac sodium softgel (formulated using ProSorb technology) with or without 100-mg caffeine versus placebo in migraineurs during migraine attacks. BACKGROUND: Diclofenac has been demonstrated to be an effective migraine treatment in several placebo-controlled studies. A rapidly absorbed softgel of diclofenac has been shown to be effective in the rapid relief of acute pain, and may have advantages in migraine treatment. In addition, caffeine has consistently been shown to increase both the efficacy and speed of onset of concurrently administered analgesics. The ability of caffeine to both enhance and accelerate analgesic effects has been documented with a variety of different medications (ie, aspirin, acetaminophen, ibuprofen, and ergotamine). METHODS: The 3-period crossover study was designed to compare diclofenac softgel 100 mg, diclofenac softgel 100 mg plus caffeine 100 mg, and placebo in the acute treatment of migraine. Subjects treated one moderate or severe attack with each study medication. The primary efficacy parameter was the percentage of subjects with headache relief at 60 minutes as defined by a reduction of headache severity from moderate or severe at baseline to absent or mild compared with placebo. Though the sample size estimate required that 72 subjects treat 3 separate attacks, 51 subjects treated 1 migraine attack, 44 treated 2 attacks, and 39 treated 3 attacks. Results.-In the placebo group, 6 (14%) of 43 subjects reported headache relief at 60 minutes versus 12 (27%) of 45 subjects in the diclofenac softgel group, and 19 (41%) of 46 subjects in the diclofenac softgel plus caffeine group. Differences were statistically significant for the diclofenac softgel plus caffeine group versus placebo (odds ratio, 4.2; 95% confidence interval, 1.3 to 13.7). Rescue medication was used by 27 (63%) of 43 subjects treated with placebo, 15 (33%) of 45 subjects treated with diclofenac softgel, and 14 (30%) of 46 subjects treated with diclofenac softgel plus caffeine. This result is highly statistically significant (chi22= 11.56, P=.003). Both the diclofenac plus caffeine (P <.03) and diclofenac only (P <.03) groups were significantly different from the placebo group in terms of the visual analog scale score at 60 minutes. CONCLUSIONS: The major finding of the present study is that diclofenac softgel plus caffeine produces statistically significant benefits relative to placebo at 60 minutes. Diclofenac softgel alone did not differ significantly from placebo, perhaps due to limits in sample size. Nonsignificant trends support the analgesic adjuvant benefit of caffeine when added to diclofenac softgels.

Adolescent↗

Consensus statement: cardiovascular safety profile of triptans (5-HT agonists) in the acute treatment of migraine.

BACKGROUND: Health care providers frequently cite concerns about cardiovascular safety of the triptans as a barrier to their use. In 2002, the American Headache Society convened the Triptan Cardiovascular Safety Expert Panel to evaluate the evidence on triptan-associated cardiovascular risk and to formulate consensus recommendations for making informed decisions for their use in patients with migraine. OBJECTIVE: To summarize the evidence reviewed by the Triptan Cardiovascular Safety Expert Panel and their recommendations for the use of triptans in clinical practice. PARTICIPANTS: The Triptan Cardiovascular Safety Expert Panel was composed of a multidisciplinary group of experts in neurology, primary care, cardiology, pharmacology, women's health, and epidemiology. EVIDENCE AND CONSENSUS PROCESS: An exhaustive search of the relevant published literature was reviewed by each panel member in preparation for an open roundtable meeting. Pertinent issues (eg, cardiovascular pharmacology of triptans, epidemiology of cardiovascular disease, cardiovascular risk assessment, migraine) were presented as a prelude to group discussion and formulation of consensus conclusions and recommendations. Follow-up meetings were held by telephone. CONCLUSIONS: (1) Most of the data on triptans are derived from patients without known coronary artery disease. (2) Chest symptoms occurring during use of triptans are generally nonserious and are not explained by ischemia. (3) The incidence of serious cardiovascular events with triptans in both clinical trials and clinical practice appears to be extremely low. (4) The cardiovascular risk-benefit profile of triptans favors their use in the absence of contraindications.

Acute Disease↗

Tools for diagnosing migraine and measuring its severity.

Migraine remains substantially underdiagnosed and undertreated in the United States. Tools to screen for migraine and to measure headache-related disability can help address barriers to effective diagnosis and treatment. In this article, public health criteria for screening programs for any medical condition are first reviewed. Modifications of these criteria for migraine and other chronic/episodic disorders are then proposed. Migraine is assessed to determine how well it meets criteria for screening and the steps that are necessary before firm public policy recommendations for screening for migraine are possible.

Disability Evaluation↗

Detecting dementia with the Hopkins Verbal Learning Test and the Mini-Mental State Examination.

The Hopkins Verbal Learning Test (HVLT) and the Mini-Mental State Examination (MMSE) were administered to 323 non-demented elderly and 70 individuals who meet DSM-IV criteria for dementia in order to compare the validity of these two measures for detecting mild dementia and for the two most common dementia subtypes, Alzheimer's disease (AD) and vascular dementia (VaD). The study was conducted in an elderly, ethnically diverse community-dwelling population. Sensitivity, specificity, positive and negative predictive values were calculated over a range of clinically relevant cut scores for each test. We analyzed the influence of age, education, reading ability and sex on test performance using logistic regression models. When sensitivity is held constant at 0.69, the specificity for the HVLT total recall was 0.89 and the MMSE 0.82 for all dementias (P=.10). Age, sex and education did not significantly influence test performance for either test in this sample. Results were similar for AD and VaD. However, while adding a measure of reading ability to the regression models did not affect the overall dementia model, it resulted in improved specificities when combined with the MMSE for AD and combined with the HVLT for VaD. Additional tests such as reading ability can improve discrimination of dementia subtypes. The modest sensitivity of either the HVLT or the MMSE alone suggests that further neuropsychological evaluation is required to confirm dementia diagnosis.

Aged↗

The prevalence of migraine in neurologists.

To assess the prevalence of migraine among neurologists and neurologist headache specialists, the authors performed a survey of neurologists who attended a headache review course. The 1-year and lifetime prevalences of migraine in the 220 respondents were as follows: male neurologists, 34.7%, 46.6%; male headache specialists, 59.3%, 71.9%; female neurologists, 58.1%, 62.8%; and female headache specialists, 74.1%, 81.5%. Migraine is much more prevalent among neurologists than in the general population.

Adult↗

Leisure activities and the risk of dementia in the elderly.

BACKGROUND: Participation in leisure activities has been associated with a lower risk of dementia. It is unclear whether increased participation in leisure activities lowers the risk of dementia or participation in leisure activities declines during the preclinical phase of dementia. METHODS: We examined the relation between leisure activities and the risk of dementia in a prospective cohort of 469 subjects older than 75 years of age who resided in the community and did not have dementia at base line. We examined the frequency of participation in leisure activities at enrollment and derived cognitive-activity and physical-activity scales in which the units of measure were activity-days per week. Cox proportional-hazards analysis was used to evaluate the risk of dementia according to the base-line level of participation in leisure activities, with adjustment for age, sex, educational level, presence or absence of chronic medical illnesses, and base-line cognitive status. RESULTS: Over a median follow-up period of 5.1 years, dementia developed in 124 subjects (Alzheimer's disease in 61 subjects, vascular dementia in 30, mixed dementia in 25, and other types of dementia in 8). Among leisure activities, reading, playing board games, playing musical instruments, and dancing were associated with a reduced risk of dementia. A one-point increment in the cognitive-activity score was significantly associated with a reduced risk of dementia (hazard ratio, 0.93 [95 percent confidence interval, 0.90 to 0.97]), but a one-point increment in the physical-activity score was not (hazard ratio, 1.00). The association with the cognitive-activity score persisted after the exclusion of the subjects with possible preclinical dementia at base line. Results were similar for Alzheimer's disease and vascular dementia. In linear mixed models, increased participation in cognitive activities at base line was associated with reduced rates of decline in memory. CONCLUSIONS: Participation in leisure activities is associated with a reduced risk of dementia, even after adjustment for base-line cognitive status and after the exclusion of subjects with possible preclinical dementia. Controlled trials are needed to assess the protective effect of cognitive leisure activities on the risk of dementia.

Aged↗

Telephone screening for amnestic mild cognitive impairment.

OBJECTIVES: To evaluate the utility of telephone screening for identifying subjects with amnestic mild cognitive impairment (aMCI) for enrollment in a clinical trial and to identify which elements of the modified Telephone Interview for Cognitive Status (TICS-m) best predicted the in-clinic determination of aMCI. METHODS: Subjects aged >/=65 years with memory complaints responded to an advertisement for a clinical trial by calling a central telephone recruiting agency. To determine eligibility, subjects went through a stepwise selection procedure involving a review of major protocol inclusion and exclusion criteria, followed by administration of the Category Fluency Test (CFT) and then the TICS-m. Subjects meeting entry criteria, who obtained a score of </=13 on the CFT for "animals" and </=24 on the CFT for "animals" and "fruits" and who scored between 19 and 38 on the TICS-m, were referred for a clinic appointment to determine whether they met clinical criteria for aMCI. Clinical criteria for aMCI required a score of >/=24 on the Mini-Mental State Examination and a score of </=37 on the Rey Auditory Verbal Learning Test. A post hoc analysis was performed using factor analysis and logistic regression models to investigate which elements of the TICS-m best predicted the in-clinic determination of aMCI. RESULTS: Of 16,988 subjects who called the telephone agency, 8,742 passed the review of inclusion/exclusion criteria; 6,090 met the CFT cut scores and received the TICS-m; 5,223 met cut scores on the TICS-m and were referred for an in-clinic appointment; 747 were seen in the clinic; and 324 met clinical criteria for aMCI. Factor analysis indicated three factors on the TICS-m: language/attention, orientation, and memory. The memory factor, comprising immediate and delayed recall of a word list, was the most important contributor for identifying subjects who met clinical criteria for aMCI. CONCLUSION: Only 2% of subjects who underwent telephone screening were recruited into the study, but 43% of those who passed telephone screening and were seen in the clinic met clinical criteria for aMCI. The word recall tests of the TICS-m were the most important items for identifying which subjects met clinical criteria for aMCI.

Age Distribution↗

Modeling memory decline in older adults: the importance of preclinical dementia, attrition, and chronological age.

This longitudinal study examined memory loss in a sample of 391 initially nondemented older adults. Analyses decomposed observed memory loss into decline associated with preclinical dementia, study attrition, terminal decline, and chronological age. Measuring memory as a function of only chronological age failed to provide an adequate representation of cognitive change. Disease progression accounted for virtually all of the memory loss in the 25% of the sample that developed diagnosable dementia. In the remainder of the sample, both chronological age and study attrition contributed to observed memory loss. These results suggest that much of memory loss in aging adults may be attributable to the progression of preclinical dementia and other nonnormative aging processes that are not captured by chronological age.

Aged↗

Migraine disability assessment (MIDAS) score: relation to headache frequency, pain intensity, and headache symptoms.

OBJECTIVE: To determine the extent to which variation in the Migraine Disability Assessment (MIDAS) score is associated with headache frequency, pain intensity, headache symptoms, gender, and employment status. BACKGROUND: The MIDAS questionnaire is a 7-item questionnaire (with 5 scored items) designed to measure headache-related disability, to improve physician-patient communication, and to identify patients with high treatment needs. METHODS: Data from 3 population-based studies (total sample, n = 397) conducted in the United States and the United Kingdom were used to evaluate the relationship between headache features (attack frequency, pain intensity, pain quality, and associated symptoms) and MIDAS score. Data on headache features were collected by telephone using a standardized interview. The MIDAS questionnaire was completed shortly after the telephone interview. General linear models were used to determine the extent to which population variation in the MIDAS score was explained by headache features. RESULTS: Using linear regression, variables for all headache features (ie, headache frequency, pain intensity, pain quality, and associated symptoms) and demographic characteristics explained only 22% of the variation in MIDAS scores. Almost all (19.9%) the explained variance was accounted for by average pain intensity (12.0%), number of headache days (6.1%), and exacerbation of pain with movement (1.8%). When pain intensity and headache frequency were included in the model, no statistically significant differences in MIDAS scores were observed by gender or employment status. Although explaining only 2.1% of the variance, age was significantly associated with MIDAS scores, with those under 25 years demonstrating higher MIDAS scores than other age groups. No other variables (ie, frequency of occurrence of associated symptoms and other measures of quality of pain) were associated with MIDAS scores. CONCLUSIONS: Challenges to the utility of the MIDAS as a measure include whether headache-related disability is largely a function of other routine headache features and whether MIDAS is inherently biased based on work status and gender. While the MIDAS score was associated with headache frequency and average pain score, these two headache features explain only a modest proportion of the variation in MIDAS scores. Additionally, gender and work status were not related to MIDAS scores. These findings suggest that the MIDAS score captures information about disability that is not inherent to other headache features and is independent of gender and work status.

Adult↗

Assessment of migraine disability using the migraine disability assessment (MIDAS) questionnaire: a comparison of chronic migraine with episodic migraine.

BACKGROUND: Chronic migraine is the most common type of chronic daily headache seen in headache tertiary care centers. Most patients with chronic migraine report their ability to function and feeling of well-being as severely impaired. OBJECTIVE: To measure the headache-related disability of patients with chronic migraine using the Migraine Disability Assessment (MIDAS) Questionnaire, comparing it with that obtained in a control group of patients with episodic migraine. METHODS: The clinical records of 703 patients with chronic daily headache treated in a headache specialty clinic were reviewed to identify 182 with chronic migraine who were evaluated using the MIDAS at their initial visit. Our control group consisted of 86 patients with episodic migraine. RESULTS: Of the 182 patients with chronic migraine, 127 (69.8%) were overusing acute-care medication. Patients were predominantly women (72.5%), with a mean age of 38.3 years. The group with episodic migraine consisted of 59 women (68.6%), with a mean age of 36.1 years. No statistically significant demographic differences were observed between the two groups. The group with chronic migraine had more total headache days over 3 months (66.7 versus 15.5, P<.001), missed more days of work or school (5.3 versus 2.3, P =.0007), had more reduced effectiveness days at work or school (11.9 versus 4.6, P =.0001), missed more days of housework (16.5 versus 3.3, P<.0001), and missed more days of family, social, or leisure activities (7.0 versus 5.5, P =.03). The group with chronic migraine was more likely to be in MIDAS grade IV (64.3% versus 43.2%, P =.001), reflecting the great likelihood of severe disability in this group. The average total MIDAS score was 34.9 in the group with chronic migraine versus 19.3 in the group with episodic migraine (P<.001). CONCLUSION: In subspecialty centers, patients with chronic migraine demonstrate remarkable impairment of their daily activities and are severely burdened by their headache syndrome, reflected by their high MIDAS scores. The chronicity and pervasiveness of migraine thus is associated with increased functional impairment as well as increase in headache frequency.

Adult↗