Depression among people with type 2 diabetes mellitus, US National Health and Nutrition Examination Survey (NHANES), 2005-2012.

BACKGROUND: Depression in people with diabetes can result in increased risk for diabetes-related complications. The prevalence of depression has been estimated to be 17.6 % in people with type 2 diabetes mellitus (T2DM), based on studies published between 1980 and 2005. There is a lack of more recent estimates of depression prevalence among the US general T2DM population. METHODS: The present study used the US National Health and Nutrition Examination Survey (NHANES) 2005-2012 data to provide an updated, population-based estimate for the prevalence of depression in people with T2DM. NHANES is a cross-sectional survey of a nationally representative sample of the civilian, non-institutionalized US population. Starting from 2005, the Patient Health Questionnaire (PHQ-9) was included to measure signs and symptoms of depression. We defined PHQ-9 total scores ≥ 10 as clinically relevant depression (CRD), and ≥ 15 as clinically significant depression (CSD). Self-reported current antidepressant use was also combined to estimate overall burden of depression. Predictors of CRD and CSD were investigated using survey logistic regression models. RESULTS: A total of 2182 participants with T2DM were identified. The overall prevalence of CRD and CSD among people with T2DM is 10.6 % (95 % confidence interval (CI) 8.9-12.2 %), and 4.2 % (95 % CI 3.4-5.1 %), respectively. The combined burden of depressive symptoms and antidepressants may be as high as 25.4 % (95 % CI 23.0-27.9 %). Significant predictors of CRD include age (younger than 65), sex (women), income (lower than 130 % of poverty level), education (below college), smoking (current or former smoker), body mass index (≥30 kg/m(2)), sleep problems, hospitalization in the past year, and total cholesterol (≥200 mg/dl). Significant predictors of CSD also include physical activity (below guideline) and cardiovascular diseases. CONCLUSIONS: The prevalence of CRD and CSD among people with T2DM in the US may be lower than in earlier studies, however, the burden of depression remains high. Further research with longitudinal follow-up for depression in people with T2DM is needed to understand real world effectiveness of depression management.

Factors associated with treatment of women with osteoporosis or osteopenia from a national survey.

BACKGROUND: Health outcomes could be improved if women at high risk for osteoporotic fracture were matched to effective treatment. This study determined the extent to which treatment for osteoporosis/osteopenia corresponded to the presence of specific risk factors for osteoporotic fracture. METHODS: This retrospective analysis of the United States 2007 National Health and Wellness Survey included women age ≥ 40 years who reported having a diagnosis of osteoporosis (69% of 3276) or osteopenia (31% of 3276). Patients were stratified by whether they were or were not taking prescription treatment for osteoporosis/osteopenia. Using 34 patient characteristics as covariates, logistic regression was used to determine factors associated with treatment. RESULTS: Current prescription treatment was reported by 1800 of 3276 (54.9%) women with osteoporosis/osteopenia. The following factors were associated with receiving prescription treatment: patient-reported diagnosis of osteoporosis (versus osteopenia); previous bone mineral density test; ≥ 2 fractures since age 50; older age; lower body mass index; better physical functioning; postmenopausal status; family history of osteoporosis; fewer comorbidities; prescription insurance coverage; higher total prescription count; higher ratio of prescription costs to monthly income; higher income; single status; previous visit to a rheumatologist or gynecologist; and 1 or 2 outpatient visits to healthcare provider (vs. none) in the prior 6 months. Glucocorticoid, tobacco, and daily alcohol use were risk factors for fracture that were not associated with treatment. CONCLUSIONS: There is a mismatch between those women who could benefit from treatment for osteoporosis and those who are actually treated. For example, self-reported use of glucocorticoids, tobacco, and alcohol were not associated with prescription treatment of osteoporosis. Other clinical and socioeconomic factors were associated with treatment (e.g. prescription drug coverage and higher income) or not (e.g. comorbid osteoarthritis and anxiety) and could be opportunities to improve care.

Burden of Pneumonia Among Hospitalized Patients with Influenza: Real-World Evidence from a US Managed Care Population.

INTRODUCTION: Pneumonia is among the most prevalent complications of influenza. The purpose of this study is to quantify the burden of pneumonia among hospitalized patients with influenza. METHODS: Real-world retrospective data from 01JAN2014-30JUN2019 (study period) were obtained from Optum's de-identified Clinformatics® Data Mart Database (2007-2020) for patients who had ≥ 1 diagnosis for influenza during the identification period and ≥ 1 all-cause inpatient visit within 1 day of diagnosis. Cases had ≥ 1 diagnosis claim for an influenza-related pneumonia within the 30 days after the initial influenza diagnosis date. Controls had no evidence of influenza-related pneumonia in the 30 days following the initial influenza diagnosis. Final 1:1 matching was determined using propensity score matching (PSM). Statistical significance between the cohorts was tested. RESULTS: After PSM, there were 4878 hospitalized patients with influenza in each of the case and control groups. During the index hospitalization, cases vs. controls had longer length of stay [Mean (standard deviation): 6.5 (8.3) vs. 1.9 (3.7)], greater intensive care unit (ICU) use (38.4 vs. 16.8%), and greater mechanical ventilation use (invasive: 11.4 vs. 2.3%; non-invasive: 6.8 vs. 2.6%) (all p < 0.001). Cases also had higher readmission rates than controls (12.3 vs. 3.5% within 30 days; 20.0 vs. 6.1% within 90 days; p < 0.001 for both). Post-index date direct all-cause healthcare costs were higher for cases than for controls (median total cost: $18,428 vs. $621 for 30 days; $21,774 vs. $3312 for 90 days; $25,960 vs. $8699 for 6 months; $35,875 vs. $21,619 for 1 year; all p < 0.001). CONCLUSIONS: Pneumonia as a complication of influenza increases risk of mortality and leads to greater healthcare resource use and direct medical costs among patients hospitalized with influenza. These effects are seen early during the index hospitalization and within the first 30 days after diagnosis, but their impact continues throughout a year of follow-up.

Predictors and Outcomes of Hospitalization for Influenza: Real-World Evidence from the United States Medicare Population.

INTRODUCTION: The purpose of this study was to identify predictors of initial hospitalization and describe the outcomes of high-risk patients hospitalized with influenza. METHODS: Data were taken from the 5% national US Medicare database from 2012 to 2015. Patients (aged at least 13 years) were required to have at least one diagnosis for influenza and have continuous health plan enrollment for 6 months before (baseline) and 3 months (follow-up) after the date of influenza diagnosis. Patients who died during follow-up were included. Patients were categorized as initially hospitalized if hospitalized within 0-1 day of diagnosis. High-risk initially hospitalized patients were defined as patients aged at least 65 years or those that had a diagnostic code for chronic lung disease, cardiovascular or cerebrovascular disease, or weakened immune system during baseline period. Logistic regression models were developed to determine predictors of initial hospitalization. RESULTS: The study population included 8127 high-risk patients who were initially hospitalized and 16,784 who were not hospitalized. Among high-risk patients, 89.3% were diagnosed in the emergency room, whereas 7.5% and 3.2% were diagnosed in a physician's office or other Medicare settings, respectively. Chronic obstructive pulmonary disorder, congestive heart failure, chronic kidney disease, older age, being male, other comorbidities, number of comorbidities, and baseline healthcare resource use were the predictors of hospitalization. Median length of stay for the hospitalization was 5.0 days, and the 30-day readmission rate was 14%. All-cause mortality rate was 5.1% during the inpatient stay and 9.2% within 30 days of diagnosis. Hospitalized patients with influenza incurred an increase of $16,568 per patient in total all-cause healthcare costs from pre-influenza to post-influenza diagnosis. CONCLUSION: The study characterized the burden of hospitalization for influenza and found that hospitalized high-risk patients experience greater comorbidity burden, higher likelihood of multiple inpatient admissions, and costly medical interventions compared to patients who were not hospitalized.

Predictability of future attacks by migraineurs: a prospective observational study.

OBJECTIVE: To determine the predictability of future migraine attacks and to describe the effect of migraine on daily life during and between migraine attacks. BACKGROUND: Migraine is associated with substantial economic and humanistic burden. There is growing evidence that early intervention with triptans results in better treatment outcomes. However, this is dependent on a patient's preparedness for an attack including having abortive medications readily accessible at headache onset. METHODS: Physician-diagnosed adult migraine sufferers, who treat with prescription or over-the-counter medications, completed 2 self-reported, Internet-based questionnaires, administered at baseline and following the resolution of the next migraine attack. The baseline questionnaire included the Migraine Disability Assessment questionnaire (MIDAS), questions about experiences on days between attacks, predictions of the date, time of day (5 time windows), and sufferer's location (4 places) at the start of their next migraine. At follow-up, information was collected in the similar fashion about the date, time of day, and sufferer's location at the start of their most recent migraine. RESULTS: A total of 1519 migraine sufferers completed the baseline questionnaire and 877 (57.7%) completed the follow-up. At baseline, 58.7% experienced moderate to severe disability from headache, based on MIDAS. Only 4.0% were able to predict the exact date of their next migraine; 21.24% predicted next migraine within 3 days. Larger proportions (46.6%) were able to accurately predict time of day or location (70.7%) of their next migraine. In the past 3 months, 92.6% reported that they were forced to change daily plans because of migraine. Because of fear of getting a migraine, 20.2% had avoided and 27.0% had changed a work commitment, and 27.3% had avoided and 28.2% had changed social plans. CONCLUSIONS: Migraine sufferers are generally unable to predict onset of the next migraine. Lack of predictability heightens the importance of education and preparedness for a migraine attack which may also reduce fear and anxiety between attacks.

The burden of disrupting gastro-oesophageal reflux disease: a database study in US and European cohorts.

BACKGROUND: Recent data indicate that among patients with gastro-oesophageal reflux disease (GORD) there is a subgroup with a higher disrupting burden of illness in terms of symptom frequency and overall impact. OBJECTIVE: The aim of this study was to evaluate the burden of disrupting versus non-disrupting GORD on individuals, healthcare providers and society. METHODS: Data were obtained from European (France, Germany, Italy, Spain and the UK) and US respondents in the 2007 National Health and Wellness Survey (NHWS). Respondents with GORD were classified as having disrupting or non-disrupting GORD based on self-reported symptom frequency, presence of night-time symptoms and medication usage. Disrupting GORD was defined as the presence of GORD symptoms on at least 2 days/week in addition to either night-time symptoms or use of prescribed/over-the-counter medication at least twice a week during the past month. RESULTS: Of 116 536 respondents included in the 2007 NHWS, 23% reported GORD symptoms; 39% of these were acknowledged as having disrupting GORD. These patients had higher healthcare resource utilization than those with non-disrupting disease. Respondents with disrupting GORD also had poorer health-related quality of life, greater impairments in health-related work productivity and absenteeism (all p < 0.05 vs non-disrupting GORD), and higher associated total medical costs. Overall, patients with physician-diagnosed GORD also had significantly lower health-related quality of life than self-diagnosed respondents (p < 0.05). CONCLUSIONS: GORD is a common disease that places a substantial burden on affected individuals and society. A high proportion of patients have disrupting GORD, which has significant adverse potential from both a clinical and an economic perspective.

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 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.

Characteristics and symptomatology of patients diagnosed with unipolar depression at risk for undiagnosed bipolar disorder: a bipolar survey.

OBJECTIVE: To identify characteristics of patients diagnosed with unipolar depression who may have undiagnosed bipolar disorder. METHODS: Patients diagnosed with unipolar depression by a healthcare provider were identified through the Consumer Health Sciences National Health and Wellness Survey. Manic symptoms, comorbid conditions, psychiatric symptomatology, use of healthcare resources, and patient demographics were identified through Internet-based questionnaires. A self-report adapted version of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria identified symptoms consistent with a manic episode. Psychological well-being was measured by the Psychological General Well-Being Index. RESULTS: Of the 1,602 respondents who met inclusion criteria, 219 (14% or approximately 1 out of 7) reported symptoms consistent with a manic episode and were considered at risk for undiagnosed bipolar disorder. These respondents were younger and had a lower socioeconomic status. At-risk patients rated their depression as more severe and experienced greater impairment of psychological well-being. More than 70% of those at risk reported speaking with a healthcare provider about their mania symptoms. Comorbid mental disorders, especially anxiety-related conditions, were common in these patients. CONCLUSION: These findings underscore the importance of evaluating unipolar patients for bipolar disorder and may help clinicians identify symptoms and comorbidities associated with patients with unipolar depression at risk for undiagnosed bipolar disorder.

Patient engagement in type 2 diabetes mellitus research: what patients want.

BACKGROUND: As patients are the ultimate stakeholder in their health, their perspectives should be included along with researchers, providers, and funders of research design, execution, and interpretation. Despite the high prevalence of type 2 diabetes mellitus (T2DM), patients are rarely directly included in these decisions. PURPOSE: We sought to determine areas of research most important to patients with T2DM, identify ways through which patients with T2DM want to engage in research, and evaluate online patient research networks as a source for obtaining patient perspectives on research engagement. PATIENTS AND METHODS: This study used an online patient community forum (PatientsLikeMe) to host two asynchronous moderated discussions, each with three to four prompted discussion posts. A qualitative summary of themes was derived from the posts. RESULTS: Eighty-eight participants with T2DM took part. Participants were mostly white (86%), averaged 58.6 years of age, half were female (50%), and over half (62%) resided in the US. Research priorities included managing T2DM with comorbidities, controlling blood sugar levels, finding a cure, and understanding causes of T2DM. Participants wanted to see direct applications of research to their lives. Clinical research was perceived to have overly restrictive eligibility criteria and to measure outcome sets that do not adequately address patient health concerns. Participants indicated broad interest in partnering in research and a willingness to apply their skills and educational background to specific stages in the research process. CONCLUSION: Patients with T2DM would like researchers to address outcomes that have meaning in patients' daily lives. Initiatives to involve patients in research should leverage and enable patients to contribute as participants, advisors, or co-investigators, going beyond research topic prioritization to full participation throughout the research process based on their abilities and interest. This study provides support for the use of online patient research network discussions to generate rich qualitative data to engage patients in research.

An evaluation of patients' preferences for osteoporosis medications and their attributes: the PREFER-International study.

BACKGROUND: Patients' preferences for medications may be important in determining their compliance with therapy, particularly in the case of an asymptomatic chronic disease such as osteoporosis. Although preferences for certain attributes of osteoporosis medications, including dosing frequency and tolerability, can be evaluated in short-term clinical trials, years of use may be necessary for differences in effectiveness in reducing fracture risk to emerge. OBJECTIVES: The primary aim of this study was to evaluate the relative importance of various attributes in determining patients' preferences for osteoporosis medications. Its secondary aim was to investigate patients' preferences for either of 2 hypothetical osteoporosis medications with different profiles. METHODS: The Preference for Effective Regimens (PREFER)-International study was a cross-sectional survey of postmenopausal women with osteoporosis in France, Germany, Mexico, Spain, and the United Kingdom. Participants were recruited by their physicians in the 4 European countries and were identified by trained interviewers going door to door in Mexico. Participants were administered a questionnaire in which they were asked to rate and rank the importance of 7 medication attributes in determining their preferences for prescription osteoporosis medications. The attributes were side effects, out-of-pocket costs, effectiveness in improving bone health and preventing fractures, dosing frequency, formulation, administration procedure, and length of time on the market. They were also asked to indicate their preference for 2 hypothetical osteoporosis medications whose profiles differed in terms of efficacy (medication A reduced the risk of spine and hip fracture; medication B reduced spine fracture only), time on the market (10 years vs recently introduced), dosing frequency (weekly vs monthly), and dosing procedure (30- vs 60-minute wait after dosing). RESULTS: Of 3000 patients interviewed, 1500 were receiving prescription treatment for osteoporosis. Across the rankings and ratings, effectiveness in reducing the risk of fracture emerged as the most important factor in determining patients' preferences for prescription osteoporosis medications, followed by side effects. Out-of-pocket costs, dosing frequency, formulation, time on the market, and dosing procedure were less important considerations among respondents from most countries. The majority (78%) of patients indicated a preference for medication A over medication B. CONCLUSION: Effectiveness in reducing fracture risk was cited as the primary reason for patients' preference for prescription osteoporosis medications among postmenopausal women with osteoporosis from 4 European countries and Mexico.

Treatment satisfaction with a transdermal contraceptive patch or oral contraceptives.

OBJECTIVE: The study was conducted to examine the influence of demographics, health-related quality of life (HRQL) and duration of use on satisfaction with the transdermal contraceptive patch or oral contraceptives (OCs). METHODS: In this cross-sectional analysis of the 2004 National Health and Wellness Survey (NHWS), women were currently using the patch (n=257) or OCs (n=1824). Outcome variable was a five-point satisfaction scale (1=not at all; 5=extremely). Satisfaction rates were computed as the percentage of patients reporting a 4 or 5. Independent variables included demographics, HRQL (SF-8), duration of use, and treatment (patch or OCs). Logistic regression evaluated association of independent variables. RESULTS: Patch use was associated with significantly higher satisfaction than OCs (OR=2.05; 95% CI=1.34-3.15; p=.001) in the logistic regression model. Months using product (p<.001), days used product in past month (p<.001) and mental well-being (p=.02) were other variables associated with satisfaction. CONCLUSION: Patch use, duration of use and mental well-being were associated with satisfaction.

Quality of life among bipolar disorder patients misdiagnosed with major depressive disorder.

OBJECTIVE: Bipolar disorder is frequently misdiagnosed as major depressive disorder (MDD). We aim to quantify the prevalence of misdiagnosed bipolar disorder among the depression population and evaluate the quality-of-life (QOL) impact of misdiagnoses. METHOD: Data were collected from 2 self-administered, cross-sectional studies in 2003. Patients participating in The Bipolar Disorder Misdiagnosis Study (N = 1156) were previously diagnosed with depression, experienced a depressive episode within the past year, and had no previous diagnosis of bipolar disorder or schizophrenia. Patients who experienced a manic episode in the past year, based on DSM-IV criteria, were classified as misdiagnosed. Patients participating in The Bipolar Disorder Project (N = 1214) self-reported a diagnosis of bipolar disorder and were recruited through community mental health centers and support groups. Quality of life was assessed via the Psychological General Well-Being (PGWB) Index and Medical Outcomes Study 8-Item Short-Form Health Survey (SF-8). Demographic differences between groups were controlled using linear regression models. RESULTS: Of the diagnosed MDD sample, 14.3% met criteria for misdiagnosed bipolar disorder. When controlling for demographic differences, the PGWB overall score for the misdiag-nosed averaged 12.77 (p < .001) points lower than that of MDD patients and 9.55 (p < .001) points lower than that of diagnosed bipolar disorder patients. The average SF-8 mental component summary score for the misdiagnosed was 5.85 (p < .001) points lower than that of MDD patients and 3.18 (p = .002) points lower than that of diagnosed bipolar disorder patients. CONCLUSION: Misdiagnosis is associated with poorer QOL than MDD or diagnosed bipolar disorder, which are recognized as having a considerable impact on QOL.

Assessment of Rheumatoid Arthritis Quality Process Measures and Associated Costs.

The objective was to examine the relationship between health care costs and quality in rheumatoid arthritis (RA). Administrative claims were used to calculate 8 process measures for the treatment of RA. Associated health care costs were calculated for members who achieved or did not achieve each of the measures. Medical, pharmacy, and laboratory claims for RA patients (International Classification of Diseases, Ninth Revision, Clinical Modification 714.x) were extracted from the Optum Clinformatics Datamart database for 2011. Individuals were predominately female and in their mid-fifties. Measure achievement ranged from 55.9% to 80.8%. The mean cost of care for members meeting the measure was $18,644; members who did not meet the measures had a mean cost of $14,973. Primary cost drivers were pharmacy and office expenses, accounting for 42.4% and 26.3% of total costs, respectively. Regression analyses revealed statistically significant associations between biologic usage, which was more prevalent in groups attaining measures, and total expenditure across all measures (Ps < 0.001). Pharmacy costs were similar between both groups. Individuals meeting the measures had a higher proportion of costs accounted for by office visits; those not meeting the measures had a higher proportion of costs from inpatient and outpatient visits. These findings suggest that increased quality may lead to lower inpatient and outpatient hospital costs. Yet, the overall cost of RA care is likely to remain high because of intensive pharmacotherapy regimens.

Health care provider experience with canagliflozin in real-world clinical practice: favorability, treatment patterns, and patient outcomes.

PURPOSE: This study describes how health care providers approach canagliflozin for the treatment of patients with type 2 diabetes mellitus (T2DM) in the real world. PATIENTS AND METHODS: An Internet-based questionnaire was completed by 101 endocrinologists, 101 primary care physicians, and 100 nurse practitioners/physician assistants (NP/PAs). Health care providers were required to have experience prescribing or managing patients using canagliflozin to be included in the study. Health care providers compared canagliflozin with other T2DM medication classes on clinical characteristics, costs, and patient satisfaction. Confidence in canagliflozin was also measured. Health care providers reported their canagliflozin prescribing experience and good candidate characteristics for treatment. Finally, providers reported on patient outcomes among those receiving canagliflozin. All variables were compared across provider type. RESULTS: Health care providers reported higher favorability for canagliflozin for blood pressure and body weight compared with dipeptidyl peptidase-4 (DPP-4) inhibitors and higher favorability for effect on blood pressure, body weight, treatment satisfaction, and glycosylated hemoglobin (HbA1c) compared with sulfonylureas (SUs), with differences observed for effect on blood pressure. Health care providers reported being very/extremely confident (55%-74%) with canagliflozin as a second-to fourth-line treatment. The top 3 characteristics reported by the providers, in terms of describing a good candidate for canagliflozin, include those concerned about their weight, insurance coverage/affordability, and avoiding injectable treatments. Finally, providers reported often/always observing patients' lowering or controlling HbA1c (82%-88%) and improvement in overall quality of life (QoL; 50%-53%) with canagliflozin treatment. No differences were observed across provider type for confidence, good candidate characteristics, or patient outcomes. CONCLUSION: Health care providers reported favorable experiences with canagliflozin and witnessed improvements in patients' clinical outcomes and QoL.

Healthcare costs of urinary tract infections and genital mycotic infections among patients with type 2 diabetes mellitus initiated on canagliflozin: a retrospective cohort study.

OBJECTIVE: To assess the economic impact of urinary tract infections (UTIs) and genital mycotic infections (GMIs) among patients with type 2 diabetes mellitus (T2DM) initiated on canagliflozin. METHODS: Administrative claims data from April 2013 through June 2014 MarketScan® databases were extracted. Adults with ≥1 claim for canagliflozin, T2DM diagnosis, and ≥90 days enrollment before and after canagliflozin initiation were propensity score matched to controls with T2DM initiated on other anti-hyperglycemic agents (AHAs). UTI and GMI healthcare costs were evaluated 90-days post-index and reported as cohort means. RESULTS: Rates of UTI claims 90 days post-index were similar in patients receiving canagliflozin for T2DM (n = 31,257) and matched controls (2.7% vs 2.8%, p = .677). More canagliflozin than control patients had GMI claims (1.2% vs 0.6%, p < .001) and antifungal utilization (5.3% vs 2.6%, p < .001). Mean post-index costs to treat UTIs were lower but not significantly different for canagliflozin patients vs matched controls ($27.61 vs $37.33, p = .150). GMI treatment costs were higher for the canagliflozin cohort ($3.68 vs $2.44, p = .041). Combined costs to treat either UTI and/or GMI averaged $31.29 per patient for the canagliflozin cohort v $39.77 for controls (p = .211). Rates and costs of UTIs and GMIs were higher for females than males, but the canagliflozin vs control trends observed for the overall sample were similar for both sexes. There were no significant cost differences between the canagliflozin and control cohorts among patients aged 18-64. Among patients aged 65 and above, GMI treatment costs were not significantly different, but costs to treat UTIs and either UTI and/or GMI were significantly lower for canagliflozin patients vs controls. CONCLUSIONS: In a real-world setting, the costs to payers of treating UTIs and GMIs are generally similar for patients with T2DM initiated on canagliflozin vs other AHAs.

The association of weight loss with patient experience and outcomes in a population of patients with type 2 diabetes mellitus prescribed canagliflozin.

OBJECTIVE: Type 2 diabetes mellitus (T2DM) is a chronic condition complicated by being overweight or obese. This study used a patient survey to assess health, satisfaction, and diabetes self-management in relation to weight management. METHODS: A survey including the Current Health Satisfaction Questionnaire, Diabetes Distress Scale, and Diabetes Treatment Satisfaction Questionnaire was administered using an online platform to a sample of 205 patients with T2DM prescribed canagliflozin. Patients were placed into 5 groups based on their self-reported weight change since initiation of canagliflozin: Lost >10 lbs, Lost 5-10 lbs, Lost <5 lbs, No Change, and Gained Weight. One-way ANOVAs, Kruskall-Wallis tests, and multivariable regression were used to explore differences between weight loss groups. RESULTS: The majority of patients (66.8%) reported losing weight. Compared to other groups, patients who lost >10 lbs were more likely to be engaged in a weight loss program for at least 6 months. Patients in the Lost >10 lbs and Lost 5-10 lbs groups reported the greatest satisfaction with canagliflozin (p<0.05 for both). Multivariable analyses controlling for patient demographic and treatment characteristics revealed that losing >10 lbs was associated with reduced diabetes distress, improved A1c and blood glucose levels, and decreased perceived frequency of hyperglycemia (p<0.05). CONCLUSION: Increased positive patient outcomes, engagement in diabetes self-management, and medication satisfaction were observed among patients who reported weight loss. These findings suggest that a T2DM regimen that includes canagliflozin as part of a weight loss regimen can help improve patient outcomes and experiences with T2DM.

Patient experience with intravenous biologic therapies for ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, and ulcerative colitis.

OBJECTIVE: The objective of this study was to describe patient experience with intravenous (IV) biologics for ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, or ulcerative colitis. METHODS: Semi-structured telephone interviews were conducted in 405 patients with these autoimmune diseases who were receiving an IV biologic to treat their disease. RESULTS: On a 7-point scale (1= not at all satisfied; 7= very satisfied), mean satisfaction with IV medication was rated 6.1; 77% of patients rated satisfaction as 6 or 7. The most frequently perceived benefits of IV therapy were related to supervision provided by health care professionals. Most patients (82%, n=332) preferred their IV medication to subcutaneous injection. The three most common reasons for preferring IV were not wanting to self-inject (43%), less frequent dosing (34%), and preference for administration by a health care professional (24%). African-American/black patients had a stronger preference for IV administration than Caucasian/white patients (97% vs 80%, P<0.05) and a greater dislike of needles/self-injection (71% vs 40%, P<0.05). Hospital outpatient departments were not rated as well as physician in-office infusion. Only half (49%) of the patients reported that both they and their physician equally influenced the choice to switch from subcutaneous to IV therapy, and only 30% were given a choice of infusion center. CONCLUSION: Users of IV biologics are highly satisfied with their medications and perceive the opportunity for health care provider interaction at their infusion facilities as an advantage of their regimen. These findings support continued need for IV therapeutic options and shared decision-making between patients and physicians while selecting biologic treatments.

The Burden of Poor Mental Well-being Among Patients With Type 2 Diabetes Mellitus: Examining Health Care Resource Use and Work Productivity Loss.

OBJECTIVE: The aim of this study was to evaluate the association of mental well-being with outcomes among patients with type 2 diabetes mellitus (T2DM). METHODS: Seven thousand eight hundred fifty-two adults with T2DM were identified from a national, Internet-based study. Mental well-being [SF-36v2 mental component summary (MCS)] was categorized as good (MCS ≥ 50), poor (40 ≤ MCS < 50), and very poor (MCS < 40). Outcomes included past 6 months of health care resource use and lost productivity (Work Productivity and Activity Impairment questionnaire). RESULTS: Respondents with very poor/poor versus good mental well-being were more likely to visit the emergency room (27%/18% vs 11%, P < 0.001) or be hospitalized (19%/14% vs 9%, P < 0.001). Among labor force participants, those with very poor/poor versus good mental well-being experienced greater overall work impairment (43.7/26.0 vs 10.7, P < 0.001). CONCLUSIONS: Greater resource use and work productivity impairment associated with poorer mental well-being among patients with T2DM has cost implications.

Openness to and preference for attributes of biologic therapy prior to initiation among patients with rheumatoid arthritis: patient and rheumatologist perspectives and implications for decision making.

PURPOSE: Despite American College of Rheumatology recommendations, appropriate and timely initiation of biologic therapies does not always occur. This study examined openness to and preference for attributes of biologic therapies among patients with rheumatoid arthritis (RA), differences in patients' and rheumatologists' perceptions, and discussions around biologic therapy initiation. PATIENTS AND METHODS: A self-administered online survey was completed by 243 adult patients with RA in the US who were taking disease-modifying antirheumatic drugs (DMARDs) and had never taken, but had discussed biologic therapy with a rheumatologist. Patients were recruited from a consumer panel (n=142) and patient advocacy organization (n=101). A separate survey was completed by 103 rheumatologists who treated at least 25 patients with RA per month with biologic therapy. Descriptive and bivariate analyses were conducted separately for patients and rheumatologists. Attributes of biologic therapy included route of administration (intravenous infusion or subcutaneous injection), frequency of injections/infusions, and duration of infusion. RESULTS: Over half of patients (53.1%) were open to both intravenous infusion and subcutaneous injection, whereas rheumatologists reported 40.7% of patients would be open to both. Only 26.3% of patients strongly preferred subcutaneous injection, whereas rheumatologists reported 35.2%. Discrepancies were even more pronounced among specific patient types (eg, older vs younger patients and Medicare recipients). Among patients, 23% reported initiating discussion about biologics and 54% reported their rheumatologist initiated the discussion. A majority of rheumatologists reported discussing in detail several key aspects of biologics, whereas a minority of patients reported the same. CONCLUSION: Preferences differed among patients with RA from rheumatologists' perceptions of these preferences for biologic therapy, including greater openness to intravenous infusion among patients than assumed by rheumatologists and relative lack of discussion about key aspects of biologic therapy perceived by patients. There is a need for more open communication about treatment options, which may encourage more appropriate, timely transition to biologic therapy.