Determinants of glycaemic control in a practice setting: the role of weight loss and treatment adherence (The DELTA Study).

AIMS: Examine the association between weight loss and adherence with glycaemic goal attainment in patients with inadequately controlled T2DM. MATERIALS AND METHODS: Patients ≥ 18 years with T2DM from a US integrated health system starting a new class of diabetes medication between 11/1/10 and 4/30/11 (index date) with baseline HbA1c ≥ 7.0% were included in this cohort study. Target HbA1c and weight change were defined at 6-months as HbA1c < 7.0% and ≥ 3% loss in body weight. Patient-reported medication adherence was assessed per the Medication Adherence Reporting Scale. Structural equation modelling was used to describe simultaneous associations between adherence, weight loss and HbA1c goal attainment. RESULTS: Inclusion criteria were met by 477 patients; mean (SD) age 59.1 (11.6) years; 50.9% were female; 30.4% were treatment naïve; baseline HbA1c 8.6% (1.6); weight 102.0 kg (23.0). Most patients (67.9%) reported being adherent to the index diabetes medication. At 6 months mean weight change was -1.3 (5.1) kg (p = 0.39); 28.1% had weight loss of ≥ 3%. Mean HbA1c change was -1.2% (1.8) (p< 0.001); 42.8% attained HbA1c goal. Adherent patients (OR 1.70; p = 0.02) and diabetes therapies that lead to weight loss (metformin, GLP-1) were associated with weight loss ≥ 3% (OR 2.96; p< 0.001). Weight loss (OR 3.60; p < 0.001) and adherence (OR 1.59; p < 0.001) were associated with HbA1c goal attainment. CONCLUSIONS: Weight loss ≥ 3% and medication adherence were associated with HbA1c goal attainment in T2DM; weight loss was a stronger predictor of goal attainment than medication adherence in this study population. It is important to consider weight-effect properties, in addition to patient-centric adherence counselling, when prescribing diabetes therapy.

Familial risk of migraine: variation by proband age at onset and headache severity.

BACKGROUND: It is well established that migraine aggregates within families. Less is known about the influence of proband characteristics (e.g., age at onset, headache severity) on familial aggregation. OBJECTIVE: To examine the association between the proband's migraine severity and age at migraine onset and familial aggregation of migraine. METHODS: The authors investigated the migraine prevalence in first-degree relatives of 532 persons with migraine and control subjects in a population study. Familial aggregation was expressed as the risk of migraine in family members of probands divided by risk in control family members. RESULTS: The relative risk (RR) of migraine in first-degree relatives of migraine probands was elevated compared with family members of controls (RR = 1.88; 95% CI: 1.30 to 2.72). The RR was also significantly higher for relatives of probands reporting onset of migraine before age 16 (2.50; 95% CI: 1.65 to 3.79) compared with those with onset at age 16 or older (1.44; 95% CI: 0.93 to 2.23). Among probands with very severe average pain scores (i.e., 9 to 10 on a 0 to 10 scale), the RR of migraine in family members was 2.38 (95% CI: 1.56 to 3.62) compared with 1.52 (0.99 to 2.34) for less severe pain (p < 0.05). CONCLUSION: Early onset of migraine in the proband as well as the severity of migraines are associated with higher levels of family aggregation.

How treatment priorities influence triptan preferences in clinical practice: perspectives of migraine sufferers, neurologists, and primary care physicians.

BACKGROUND: In treating migraine sufferers, physicians can choose from among seven triptans with different attributes. OBJECTIVE: To develop a system for selecting an oral triptan based on treatment priorities of migraine sufferers, neurologists, and primary care physicians (PCPs) in the United States, and evidence-based performance of triptans in clinical trials. METHODS: The TRIPSTAR project combines data on the treatment preferences of migraineurs and physicians with results from a meta-analysis of individual triptans, which evaluated their effectiveness on various clinical endpoints. Telephone interviews with migraine sufferers, neurol ogists, and PCPs were conducted to elicit individual views on the relative importance of a prespecified set of acute treatment outcomes. Four hundred and fifteen migraine sufferers, both triptan-experienced and triptan-naive, were interviewed. Also, 200 board-certified neurologists and 200 PCPs provided information on migraine patients from their clinical practice. A multiattribute decision model for selecting an oral triptan was constructed using attribute importance weights collected at telephone interview and the meta-analysis data, which were drawn from 53 clinical trials of 6 oral triptans. RESULTS: Efficacy attributes were rated significantly more important than tolerability or consistency in selecting an oral triptan, according to migraine sufferers and physicians. Freedom from cardiovascular adverse events was the most important tolerability attribute, according to migraine sufferers and physicians alike. Pain free at 1 h was the most important lower-level efficacy attribute for migraine sufferers, while sustained pain free was most important for physicians. When weighted treatment attributes were combined with meta-analysis data in a multi-attribute decision model, almotriptan 12.5 mg, eletriptan 80 mg, and rizatriptan 10 mg were significantly closer to the hypothetical ideal triptan than was suma triptan 100 mg. Triptans selected by the model were generally closer to the patient-specific ideal triptan than were the triptans prescribed by physicians. CONCLUSIONS: Almotriptan, eletriptan, and rizatriptan were the three triptans closest to the ideal, from the perspectives of migraine sufferers, PCPs, and neurologists alike. The TRIPSTAR model may be a potentially useful decision-support tool to help physicians select the triptan most likely to produce a successful outcome in migraine sufferers.

Migraine practice patterns among neurologists.

OBJECTIVE: To assess the attitudes, knowledge, and practice patterns of US neurologists regarding migraine management relative to the US Headache Consortium Guidelines (the Guidelines). METHODS: Two samples of 600 neurologists each were selected from the American Academy of Neurology membership database. The first group received a Migraine Attitudes, Knowledge, and Practice Patterns (MKAPP) Survey. The second group received a Clinical Vignette (CV) Survey, presenting two patient histories and correspondent questions. RESULTS: The MKAPP Survey showed that most neurologists felt that migraine was primarily a disease of the brain with a well-established neurobiological basis (69%) and an important part of their practice (60%). Most (53%) indicated that they routinely used neuroimaging in evaluating severe headache, an approach not recommended by the Guidelines. Most favored acute treatment limits, but 36% did not agree with the Guidelines that acute treatment should be limited to 2 or 3 days/week. In the CV Survey, for vignette 1, most (91%) correctly diagnosed migraine, 31% requested neuroimaging in the absence of indications, 64% appropriately recommended a triptan, and 45% recommended a preventive medication in the absence of indications. For vignette 2, 78% diagnosed migraine, 71% appropriately ordered neuroimaging, 80% appropriately recommended a preventive medication, and 38% prescribed a triptan in face of clear contraindication. CONCLUSIONS: Educational initiatives aiming to increase the awareness of the Guidelines among neurologists should highlight the full range of migraine symptoms that support the diagnosis, appropriate use of neuroimaging, indications for preventive treatments, issues of triptan cardiovascular safety, and preventing rebound headaches.

The family impact of migraine: population-based studies in the USA and UK.

Despite an extensive body of research on the individual burden of migraine, few studies have examined its impact on the family. We aimed to assess the impact of migraine on family life both from the perspective of those with migraine and from the perspective of their partners. A validated computer-assisted telephone interview (CATI) identified 574 people with migraine from a population sample of 4007 in mainland England, and 568 from 4376 in Philadelphia County, in the USA. Migraine cases with six or more migraine attacks per year and living as married with partners were asked, along with their partners, to participate in this study. In a follow-up interview, questions were asked of the proband (i.e. subject identified with migraine in the survey) about the impact of migraine. Similar questions were also asked of the probands' partners regarding the impact of the proband's migraine on their participation in social, family and leisure activities and on family relationships. The samples from the two countries showed similar characteristics, and were combined. Of 389 people with migraine living with a household partner, 85% reported substantial reductions in their ability to do household work and chores, 45% missed family social and leisure activities, and 32% avoided making plans for fear of cancellation due to headaches. One half believed that, because of their migraine, they were more likely to argue with their partners (50%) and children (52%), while majorities (52-73%) reported other adverse consequences for their relationships with their partner and children, and at work. A third (36%) believed they would be better partners but for their headaches. Participating partners (n = 100) partly confirmed these findings: 29% felt that arguments were more common because of headaches and 20-60% reported other negative effects on relationships at home. Compared with subjects who did not have migraine regarding their work performance, a statistically significantly higher proportion of migraine partners were unsatisfied with work demands placed on them (P = 0.02), with their level or responsibilities and duties (P = 0.02), and with their ability to perform (P = 0.001). Results from this study show that the impact of migraine extends to household partners and other family members.

Migraine headache disability and health-related quality-of-life: a population-based case-control study from England.

The aims of this study were: (i) to compare health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) in a population sample of migraine headache sufferers and controls without migraine; (ii) to assess the relationship of HRQoL and work-related disability attributed to headache in a population sample. The study was conducted in two phases. First, a population-based, telephone interview survey of 5769 residents of greater London, England was conducted to identify individuals with migraine headache (cases) and controls without migraine. In the second stage, in-person interviews were conducted in a matched sample of 200 migraine cases and 200 controls selected from survey respondents. At the beginning of the in-person interview, participants were asked to complete the SF-36. In addition, a work-related disability score based on the telephone interview was defined as the number of lost work days or days when usual activity was reduced by 50% or more over the previous year. The disability score was trichotomized as mild (n = 98), moderate (n = 49), and severe disability (n = 49). Compared with controls, individuals with migraine headache scored significantly lower in eight of the nine domains of the SF-36 as well as in the overall Physical Component Summary (PCS) score and Mental Component Summary (MCS) score. Further, among migraine sufferers, each of the disability groups scored significantly lower in seven of the nine domains and in the summary scales. Scores showed greater reductions in HRQoL for the moderate and severe disability groups vs. the mild disability group in five of nine scales and in the Total Physical Summary score. We conclude that, in a population-based sample of migraine headache sufferers, individuals with migraine headache have lower HRQoL scores compared with controls. Moreover, among individuals with migraine headache, work-related disability is associated with lower HRQoL scores. Specifically, individuals classified with moderate to severe work-related disability had lower HRQoL scores than those classified with low disability.

Patterns of health care utilization for migraine in England and in the United States.

OBJECTIVE: To assess patterns of medical consultation, diagnosis, and medication use in representative samples of adults with migraine in England and the United States. METHODS: Validated computer-assisted telephone interviews were conducted in the United Kingdom (n = 4,007) and the United States (n = 4,376). Individuals who reported six or more headaches per year meeting the criteria for migraine were interviewed. RESULTS: Patients with migraine in the United Kingdom were more likely to have consulted a doctor for headache at least once in their lifetime (86% vs 69%, p < 0.0001), but also were more likely to have lapsed from medical care (37% vs 21%, p < 0.001). In the United States, patients with migraine who had consulted made more office visits for headache and were more likely to see a specialist. In the United States, but not in the United Kingdom, women with migraine were more likely than men to consult doctors for headache. Patients with migraine in the United Kingdom were more likely to receive a medical diagnosis of migraine (UK 67%, US 56%; p < 0.05). Patterns of medication use were similar in both countries, with most people treating with over-the-counter (OTC) medications. Substantial disability occurred in a high proportion of those who never consulted (UK 60%, US 68%), never received a correct medical diagnosis (UK 64%, US 77%), and treated only with OTC medication (UK 72%, US 70%). CONCLUSION: Medically unrecognized migraine remains an important health problem both in the United States and the United Kingdom. Furthermore, there may be barriers to consultation for men in the United States that do not operate in the United Kingdom.

Health-related quality of life among adults with symptoms of overactive bladder: results from a U.S. community-based survey.

OBJECTIVES: To assess, by means of a survey, the impact of the symptoms of overactive bladder (urinary frequency, urgency, and urge incontinence) on the quality of life in a community-based sample of the U.S. population. METHODS: A telephone survey was conducted in the United States among an age and sex-stratified sample of 4896 noninstitutionalized adults 18 years of age and older. From the responses to the telephone survey, a total of 483 individuals with symptoms of overactive bladder and 191 controls completed a mailed follow-up questionnaire to assess their quality of life using the Medical Outcomes Study Short-Form 20. RESULTS: After adjustment for age, sex, and the use of medical care, the greatest differences in the quality-of-life scores between the patients with incontinent overactive bladders and the controls were in the health perception (17.6 points; P <0.001) and role functioning (13.0 points; P <0.001) scales. Those with an overactive bladder with the symptoms of frequency or urgency, or both, but without incontinence, also had significantly lower scores than did the controls in mental health (P = 0.026), health perception (P = 0.01), and bodily pain (P = 0.016). CONCLUSIONS: These data indicate that individuals with an overactive bladder experience decrements in their quality of life relative to community controls. An important new finding from this study is that individuals with an overactive bladder, even without demonstrable urine loss, also have a poorer quality of life than that of controls.

Abdominal pain, bloating, and diarrhea in the United States: prevalence and impact.

The prevalence and impact of abdominal pain, bloating, and diarrhea in the adult US population are largely unknown. We conducted a national, cross-sectional, telephone survey of US households to provide estimates of the frequency, duration, severity, and impact of specific digestive symptoms during the previous month. A total of 2510 subjects completed interviews (70.7% response rate). Among the respondents, 1017 (40.5%) reported one or more digestive symptoms within the month before the interview, including abdominal pain or discomfort 21.8%, bloating or distension 15.9%, and diarrhea or loose stools 26.9%. Women were more likely than men to report abdominal pain or discomfort (24.4% vs 17.5%) and bloating or distension (19.2% vs 10.5%), but not diarrhea or loose stools (27.1% vs 26.7%). Symptoms were less common among those > or =60 years of age. More than 65% of respondents rated symptoms as moderate or severe in intensity, and the majority reported limitations in daily activities. We conclude that digestive symptoms are more common than previously recognized and have a significant impact.

Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features.

OBJECTIVE: Constipation is a common heterogeneous condition, possibly encompassing different clinical subtypes. Little is known about the comparative epidemiology of constipation subtypes. This study was conducted to estimate the prevalence of constipation subtypes and determine whether subtypes differ by sociodemographic factors. METHODS: Between June and September 1997, a telephone interview was conducted with individuals about their bowel habits in the preceding 3 months. Survey data on 15 constipation-related symptoms were used to identify individuals who met prespecified symptom criteria for the following mutually exclusive subgroups: functional constipation, irritable bowel syndrome (IBS), outlet obstruction or delay (outlet), both IBS and outlet (IBS-outlet), and frequent laxative users (i.e., at least every other day). A total of 10,018 eligible individuals in the United States 18 yr of age or older completed the interview. Test-retest reliability of reporting symptoms was assessed in a separate national survey. The Spearman's correlation coefficient for reporting symptoms ranged from 0.54 to 0.83; all but three symptoms had correlations above 0.68. RESULTS: The overall prevalence of constipation was 14.7%. By subtype, prevalence was 4.6% for functional, 2.1% for IBS, 4.6% for outlet, and 3.4% for IBS-outlet. An additional 1.8% of respondents reported laxative use at least every other day. Outlet was the most common subtype among women, whereas functional constipation was the most common subtype among men. The gender ratio varied by subtype, with elevated ratios for outlet (F/M = 1.65) and IBS-outlet (F/M = 2.27) subtypes. The age pattern differed among each of the four subtypes. Prevalence of functional subtype decreased with increasing age. In contrast, outlet subtype did not seem to vary by age, and IBS (both men and women) and IBS-outlet (women only) subtypes increased to age 35 yr and declined thereafter. Prevalence of functional constipation increased with increasing education. Outlet type was more common in nonwhites compared to whites. Finally, 45% of individuals with constipation reported having the condition for 5 yr or more. CONCLUSIONS: Constipation is a heterogeneous condition. Differences in epidemiological profile by age, sex ratio, and relation to other sociodemographical factors support the distinction of two and possibly more symptom-based subtypes.

An international study to assess reliability of the Migraine Disability Assessment (MIDAS) score.

BACKGROUND: The Migraine Disability Assessment (MIDAS) instrument is a five-item questionnaire developed to measure headache-related disability and improve doctor-patient communication about the functional consequences of migraine. OBJECTIVES: To examine the test-retest reliability and internal consistency of the five items and of the overall MIDAS score in population-based samples of migraine sufferers in two countries and to compare consistency across countries. METHODS: Using a clinically validated telephone interview, population-based samples of migraine-headache sufferers were identified in the United States (Baltimore, MD) and the United Kingdom (Merton and Sutton, Surrey). Eligible individuals completed the MIDAS questionnaire on two occasions an average of 3 weeks apart. The MIDAS score is derived from five questions about missed time from work and household work (one question each about missed days and days with at least 50% reduced productivity) and missed days of nonwork activities. RESULTS: A total of 97 migraine-headache sufferers from the United States and 100 from the United Kingdom completed the MIDAS questionnaire twice. Mean and median item values and overall MIDAS scores were similar between the United States and the United Kingdom. Test-retest Spearman correlations of individual items ranged from 0.46 to 0.78. No significant differences in item-specific correlations were observed between the United States and United Kingdom. The test-retest Pearson correlation of the MIDAS score (i.e., sum of lost days and reduced-effectiveness days in each domain) was 0.80 in the United States and 0.83 in the United Kingdom. The Cronbach alpha, a measure of internal consistency, was 0.76 in the United States and 0.73 in the United Kingdom. CONCLUSIONS: This is the first international population-based study to assess the reliability of a disability-related illness severity score for migraine. The reliability and internal consistency of the Migraine Disability Assessment score are similar to that of a previous questionnaire (Headache Impact Questionnaire). However, the Migraine Disability Assessment score requires fewer questions, is easier to score, and provides intuitively meaningful information on lost days of activity in three domains.

Longitudinal study of brainstem auditory evoked responses in 87 normal human subjects.

We evaluated the reproducibility of brainstem auditory evoked responses (BAERs) in 87 normal individuals in a longitudinal study by estimating the correlation coefficients and variability of the interpeak intervals and the V/I amplitude ratio between trials on the same day and between sessions spaced 2 years apart. The highest correlation coefficients occur for the I-V interpeak interval between trials on the same day. The coefficients for the I-III and III-V intervals are lower, due to the variability of wave III. The correlations between ears done on the same day are lower still and are similar to measures obtained from the same ear at a 2-year interval. BAERs are more variable than previously believed between ears and over time, but not in a manner that is clinically significant and can be used longitudinally as a measure of neurologic disease. Finally, we provide the sample size required to detect a significant change in interpeak intervals.