Susan C. Bolge

The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1).

OBJECTIVE This multinational, Internet-based survey was designed to assess the prevalence, frequency, severity, and impact of opioid-induced bowel dysfunction (OBD) in patients receiving opioid therapy for chronic pain and taking laxatives. DESIGN In total, 322 patients taking daily oral opioids and laxatives completed the 45-item questionnaire. At the time of the survey, 45% of patients reported <3 bowel movements per week. The most prevalent opioid-induced side effects were constipation (81%) and straining to pass a bowel movement (58%). Those side effects considered most bothersome by patients were (in order of rank) constipation, straining, fatigue, small or hard bowel movements, and insomnia. RESULTS Most of the OBD symptoms specified in the questionnaire were experienced by the majority of patients >or=4 times a week. Constipation was the OBD symptom that was most often reported as severe. Most patients reported that their OBD symptoms had at least a moderate negative impact on their overall quality of life and activities of daily living. A third of patients had missed, decreased or stopped using opioids in order to make it easier to have a bowel movement. CONCLUSION The survey findings confirm that OBD occurs frequently, despite the use of laxatives, in individuals taking daily oral opioids for chronic pain. These gastrointestinal symptoms add to the burden already experienced by chronic pain patients, negatively impacting quality of life and, in some cases, affecting opioid treatment itself.

Patient-reported tolerability issues with oral antidiabetic agents: Associations with adherence; treatment satisfaction and health-related quality of life.

AIMS The studys aim was to quantify prevalence of tolerability issues among patients with T2DM currently treated with OADs and to assess its association with treatment adherence, satisfaction and health-related quality of life (HRQL). METHODS Data were collected from the 2006-2008 US National Health and Wellness Survey and the Ailment Panel of Lightspeed Online Research, an internet-based questionnaire. Participants (N=2074) self-reported a diagnosis of T2DM, were >18 years of age and currently taking >1 OADs but not insulin, and spoke English. RESULTS The majority (71.7%) experienced at least 1 tolerability issue in the past 2 weeks; 49.7% experienced >2. Tolerability issues included signs/symptoms of hypoglycemia (57.2%), constipation/diarrhea (28%), headaches (25.6%), weight gain (22.9%) and water retention (21.0%). There was a significant association between the number of tolerability issues and both the likelihood of non-adherence (r=0.20, p<0.01) and reduced treatment satisfaction (r=-0.42, p<0.01). Each additional tolerability issue was associated with 28% greater likelihood of medication non-adherence. Constipation/diarrhea (b=-0.02, p<0.01) and symptoms of hypoglycemia (b=-0.08, p<0.01) were significantly associated with lower HRQL scores. CONCLUSIONS Optimizing OAD therapy of T2DM by improving tolerability may increase patient satisfaction, medication adherence and HRQL, and may increase the likelihood of attaining treatment goals.

Effects of Gastroesophageal Reflux Disease on Sleep and Outcomes

BACKGROUND & AIMS Nighttime symptoms of gastroesophageal reflux disease (GERD) are prevalent and have negative effects on sleep quality. We quantified the effects of GERD symptoms on sleep difficulties and their effects on outcomes. METHODS Data were obtained from a patient-reported survey conducted in 2006 among the general US population. Respondents who had experienced GERD symptoms at least twice during the past month were categorized as GERD patients and were subclassified into groups on the basis of nighttime symptoms and sleep difficulties. Outcomes included health care resource use in past 6 months, work productivity and activity impairment (WPAI), and health-related quality of life (HRQOL) based on results of the Short-Form Health Survey (SF-8). Regression analysis was used to adjust for demographics and clinical characteristics. RESULTS Of 11,685 survey respondents with GERD, 88.9% experienced nighttime symptoms, 68.3% sleep difficulties, 49.1% difficulty initiating asleep (induction symptoms), and 58.3% difficulty maintaining sleep (maintenance symptoms). Respondents with nighttime GERD symptoms were more likely to experience sleep difficulties (odds ratio, 1.53) and difficulties with induction (odds ratio, 1.43) and maintenance (odds ratio, 1.56) of sleep (P < .001 for all). Sleep difficulties were associated with 0.9 additional provider visits, a 5.5% increase in overall work impairment, a 10.9% increase in activity impairment, and reductions of 3.1 and 3.6 points in SF-8 physical and mental summary scores, respectively. CONCLUSIONS Nighttime GERD symptoms are associated with interruption of sleep induction and maintenance and result in considerable economic burden and reduction in HRQOL.

The association between asthma control and health care utilization, work productivity loss and health-related quality of life.

Objective: To determine the association between asthma control and health outcomes. Methods: Cross-sectional data on asthmatic patients were from the 2006 U.S. National Health and Wellness Survey. Asthma control was determined by the Asthma Control Test. Outcomes assessed included work productivity loss/activity impairment, health-related quality of life, and resource utilization. Effects of asthma control on outcomes were determined with linear and Poisson regression models. Results: There were 2767 uncontrolled asthmatics and 2912 controlled asthmatics. Adjusting for confounders, controlled asthmatics reported (P < 0.001) higher physical and mental health-related quality of life scores (SF-8); fewer emergency room visits, hospitalization days, and medical provider visits; lower levels of overall work productivity loss and activity impairment. Conclusion: Results indicate that asthma control is associated with better health outcomes. Management with therapies optimizing asthma control may reduce direct and indirect costs of treatment.

Burden of illness associated with lower urinary tract symptoms including overactive bladder/urinary incontinence.

OBJECTIVES To determine the effect of lower urinary tract symptoms, including overactive bladder/urinary incontinence, on health outcomes. METHODS Data were obtained from the 2006 U.S. National Health and Wellness Survey. Cases (those who reported experiencing a sudden overwhelming urge to urinate, a frequent urge to urinate, or urinating >8 times/d) were matched 1:1 with controls (those not experiencing any symptoms) by age, race, sex, educational attainment, and comorbidity status. The outcome measures assessed included health resource use, work productivity loss/activity impairment, and health-related quality of life. RESULTS Of the 62,833 respondents to the 2006 U.S. National Health and Wellness Survey, 13,957 case-control pairs were matched. The presence of lower urinary tract symptoms, including OAB/UI symptoms, was significantly associated with increased resource use (emergency room visits, odds ratio -1.57, 95% confidence interval -1.47-1.68; hospitalizations, odds ratio -1.56, 95% confidence interval 1.43-1.69; medical provider visits, odds ratio -1.52, 95% confidence interval 1.41-1.63), 8.03% greater overall work productivity loss (P < .001), 12.88% greater activity impairment (P < .001), and decreased health- related quality of life (mental scores, 4.07 points lower [P < .001]; physical scores, 4.14 points lower [P < .001]). CONCLUSIONS The burden of illness associated with lower urinary tract conditions, including OAB/UI, extend beyond the diagnosed population. The appropriate diagnosis and treatment of symptoms could lead to better clinical, economic, and humanistic outcomes.

The impact of migraine on work, family, and leisure among young women - a multinational study

SUMMARY Objective: To assess the impact of migraine on work, family, and leisure among young women who were employed full or part time, or as a full-time student. Research design and methods: This cross-sectional telephone survey with 6-month recall was conducted in Israel and eight European countries (Finland, Germany, Greece, Italy, Norway, Spain, Sweden, and The Netherlands). Random-digit dialing was used to identify study participants: women 18–35 years of age with migraine, who used medication to treat their migraine, and who were employed or full-time students. Results: Of 1810 participants, 42% self-reported having a physician diagnosis of migraine. During the prior 6 months, 46% of participants missed at least 1 day of work or school and 74% were prevented from functioning fully at work or school because of migraine. Mean work/school absenteeism due to migraine was 1.9 days over 6 months (range, 0.8 days in Sweden to 2.8 days in Norway). Over half of participants reported one or more occurrences of being unable to spend time with family or friends (62%) or being unable to enjoy recreational or leisure activities (67%) because of migraine. The percentage of study participants using triptans was lowest in southern Europe and highest in the Nordic countries, ranging from 1% in Greece to 50% in Sweden. Country, age, marital status, physician diagnosis of migraine, and number of migraines or severe headaches in the prior year were independent predictors of the mean number of days of migraine-related work loss. Migraine-related work loss was lowest in Sweden and greatest in Greece, Israel, and The Netherlands. Higher work loss was recorded for those 18–24 years of age; those who were separated, widowed, or divorced; those with migraine diagnosed by a physician; and those with more frequent migraines or severe headaches (≥ 24/year). The 6-month recall period used when estimating patient-reported work loss, and identifying participants with migraine based on self-reported migraine or severe headache, were the most important limitations of the study. Conclusions: We found substantial migraine-related impairment of productivity at work and school as well as of family and leisure time among young women in Israel and eight European countries.

Health-related quality of life, work productivity and health care resource use associated with constipation predominant irritable bowel syndrome

Abstract Objectives: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder. Prevalence estimates of IBS vary widely, from 10 to 15%, in the U.S. However, few studies have examined constipation predominant IBS (IBS-C), a subtype of IBS. The aim of this study was to assess the effect of IBS-C on health-related quality of life (HRQOL), work productivity and activity impairment, and health care resource use. Methods: Using data from the 2007 U.S. National Health and Wellness Survey, IBS-C patients (n = 789) were compared to a propensity-score matched comparison group (n = 789). Differences between the groups were examined on HRQOL (SF-12v2), work productivity and activity impairment (WPAI questionnaire), and self-reported resource use in the last 6 months. Results: Patients with IBS-C reported significantly lower levels of HRQOL (physical component summary score: 41.55 [95% CI: 40.72–42.37] versus 44.49 [95% CI: 43.67–45.31]; mental component summary score: 40.58 [95% CI: 39.75–41.40] vs. 45.87 [95% CI: 45.04–46.70]) and significantly higher mean levels of presenteeism (31.72% [95% CI: 28.25%–35.61%] vs. 21.43% [95% CI: 19.03%–24.15%]), overall work impairment (35.54% [95% CI: 31.76%–39.76%] vs. 25.29% [95% CI: 22.59%–28.30%]), and activity impairment (45.78% [95% CI: 43.08%–48.66%] vs. 33.03% [95% CI: 31.08%–35.11%]) than matched comparators (all P values < 0.01). Patients with IBS-C reported significantly more provider visits (8.07 [95% CI: 7.38–8.82] vs. 5.55 [95% CI: 5.07–6.08]) and emergency room visits (0.57 [95% CI: 0.46–0.70] vs. 0.36 [95% CI: 0.29–0.45]) in the past 6 months (all Ps < 0.01). No statistically significant differences between the groups were observed in absenteeism or the number of the days hospitalized. Conclusions: IBS-C was associated with poorer HRQOL, greater work productivity loss and activity impairment, and greater healthcare resource use. Limitations include the study’s cross-sectional design and its self-reported nature. Nevertheless, improved management of IBS-C may reduce the humanistic and economic burden of the condition and benefit patients, employers, and the healthcare system.

Burden associated with chronic sleep maintenance insomnia characterized by nighttime awakenings among women with menopausal symptoms

Objective: The aim of this study was to quantify the burden associated with chronic sleep maintenance insomnia characterized by nighttime awakenings (CINA) among women with menopausal symptoms. Methods: Data were obtained from the 2006 US National Health and Wellness Survey, an annual cross-sectional study of US adults 18 years or older. Analyses were limited to female respondents currently experiencing symptoms of menopause. The definition of CINA was experiencing nighttime awakenings at least twice per week for more than 1 month that have moderate to severe impact on daily life and not experiencing difficulty falling asleep. No insomnia was defined as not self-reporting insomnia, sleep difficulties, or sleep symptoms. Outcomes included resource utilization in the past 6 months, Work Productivity and Activity Impairment questionnaire, and Medical Outcomes Study Short-Form Health Survey (SF-8). Linear regression models were developed to assess the independent associations of CINA on outcomes, while adjusting for demographics and comorbidity. Results: Among women with menopausal symptoms, 141 met the criteria for CINA and 1,305 met the criteria for no insomnia. Adjusting for demographics and comorbidity, those experiencing CINA had 0.1 (P = 0.041) more emergency department visits, 20.8% (P < 0.001) greater activity impairment, and SF-8 physical and mental summary scores that were 4.7 (P < 0.001) and 5.4 (P < 0.001) points, respectively, lower than those of women who are not experiencing insomnia. Among women with menopausal symptoms employed full-time, those experiencing CINA had greater impairment while working (presenteeism; 17.3%, P < 0.001) and overall (16.1%, P < 0.001) than did those who are not experiencing insomnia. Conclusions: Among women with menopausal symptoms, CINA in relative isolation was associated with a significant negative impact on healthcare utilization and its associated costs, health-related quality of life, and work productivity.

Correlates of Medication Adherence Among Patients With Bipolar Disorder: Results of the Bipolar Evaluation of Satisfaction and Tolerability (BEST) Study: A Nationwide Cross-Sectional Survey

OBJECTIVE To identify and describe correlates of medication adherence in a large, national sample of outpatients with bipolar disorder. METHOD Data were collected via a self-report, Web-based survey in January and February of 2008 from US patients aged 18-65 years who reported a diagnosis of bipolar disorder and current use of psychotropic medication. Patients with a Composite International Diagnostic Interview-bipolar disorder (CIDI-bipolar disorder) score ≥ 7, indicating a high risk of bipolar disorder, were included in the analyses. Medication adherence was assessed via the Morisky Medication Adherence Scale, with scores ≥ 2 being considered nonadherent. The primary analysis was a multivariate binomial logistic regression with adherence as the dependent variable. Covariates included patient demographics, physical health measures including Medical Outcomes Study 8-item Short-Form Health Survey physical summary score, number of manic and depressive episodes, 24-item Behavior and Symptom Identification Scale (BASIS-24), Liverpool University Neuroleptic Side-Effect Rating Scale (LUNSERS), Satisfaction With Antipsychotic Medication scale (SWAM), and current psychiatric medication use. RESULTS Nearly half (49.5%) of the 1,052 bipolar patients in the analysis were classified as being nonadherent. Adherence was positively associated with college degree, higher SWAM total score, and monotherapy treatment. Adherence was negatively associated with female sex, alcohol use, BASIS-24 total score, and LUNSERS total score. CONCLUSIONS Nonadherence is common among patients with bipolar disorder. By addressing tolerability issues and treatment satisfaction, which are both significant correlates of adherence, health care providers may be able to improve adherence and, ultimately, treatment outcomes.

Economic and humanistic outcomes associated with comorbid type-2 diabetes, high cholesterol, and hypertension among individuals who are overweight or obese.

Objective: To assess the association of diabetes, hypertension, and high cholesterol with economic and humanistic outcomes among overweight or obese individuals. Methods: Data were from the 2006 National Health and Wellness Survey and were limited to overweight or obese adults (BMI > 27). Outcomes assessed include the SF-8, resource use, and the Work Productivity and Activity Impairment questionnaire. Independent effects of comorbid conditions were determined using linear regression models. Results: Significant associations between comorbid conditions and outcomes were noted. Comorbid conditions had significant independent effects on outcomes. The presence of all three comorbid conditions was the strongest correlate of work productivity loss (B = 13.992) and activity impairment (B = 13.397) and had the strongest negative association with SF-8 physical (B = −8.239) and mental summary scores (B = −2.605). Conclusion: Among, overweight or obese individuals, comorbid conditions are associated with greater productivity loss, resource use, and poorer quality of life.