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.

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.

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.

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.

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.

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 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.

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.

Changes in Body Weight Among People With Type 2 Diabetes Mellitus in the United States, NHANES 2005-2012.

PURPOSE: To understand weight loss strategies, weight changes, goals, and behaviors in people with type 2 diabetes mellitus (T2DM) and whether these differ by ethnicity. METHODS: T2DM was identified by self-reported diagnosis using the NHANES 2005-2012 data, which also included measured and self-reported current body weight and height, self-reported weight the prior year, and self-reported aspired weight. Nineteen weight loss strategies were evaluated for association with ≥5% weight loss or weight gain versus <5% weight change. RESULTS: Among people with T2DM, 88.0% were overweight/obese (body mass index [BMI] ≥25 kg/m(2)) in the prior year and 86.1% the current year. About 60% of the overweight/obese took weight loss actions, mostly using diet-related methods with average weight lost <5%. Two most "effective" methods reported (smoking, taking laxatives/vomiting) are also potentially most harmful. Similar BMI distributions but different goals and behaviors about weight and weight loss were observed across ethnicity. Only physical activity meeting the recommended level and changing eating habits were consistently associated with favorable and statistically significant weight change. CONCLUSIONS: Weight management in T2DM is an ongoing challenge, regardless of ethnicity/race. Among overweight/obese T2DM subjects, recommended level of physical activity and changing eating habits were associated with statistically significant favorable weight change.

Prescribing Patterns of Intravenous Golimumab for Rheumatoid Arthritis.

PURPOSE: The use of intravenous golimumab (GLM-IV), in combination with methotrexate, was approved by the US Food and Drug Administration in July 2013 for the treatment of moderate to severe, active rheumatoid arthritis (RA). GLM-IV is available in 50-mg vials, and the prescribing information specifies a dosing regimen of 2 mg/kg at 0 and 4 weeks and then every 8 weeks thereafter. The purpose of this study was to examine the patterns of prescribing and administration of GLM-IV, including the demographic, clinical, and utilization characteristics of patients with RA newly treated with GLM-IV. METHODS: Rheumatology practices across the continental United States were solicited for a chart-review study. Inclusion criteria were: (1) diagnosis of RA; (2) current treatment with GLM-IV; (3) age ≥18 years; and (4) lack of pregnancy (in female patients). Physicians were offered a monetary incentive for each eligible chart provided. An electronic case-report form was developed to aid in the chart data extraction and included fields for demographic characteristics, available comorbid diagnoses, prior RA treatments, and doses and dates of GLM-IV administration. FINDINGS: A total of 117 eligible patient charts from 15 rheumatologist practices were reviewed. The patient sample was predominantly female (81.2%), with a mean (SD) age of 55.4 (14.5) years. A total of 55.6% of patients had evidence of biologic treatment before receiving GLM-IV, and 53% had at least 1 comorbid condition. In total, 300 individual GLM-IV infusions from this sample were reviewed. Due to the relatively recent approval of GLM-IV use by the US Food and Drug Administration, the majority of patients in this sample (69.2%) had received only between 2 and 4 infusions at the time of the review. For infusion records with valid dose data, the mean number of administered vials was 3.6 (0.8) (total dose, 180 mg); the majority of patients received a dose consistent with the prescribed dose of 2 mg/kg. Combination therapy with methotrexate was observed in the charts of a minority of patients (27.4%). The mean interval between induction and the first follow-up infusion was 32.9 (11.4) days, with a mean maintenance interval of 56.5 (13.3) days. IMPLICATIONS: This analysis provides an early glimpse of the patterns of prescribing GLM-IV. Overall, patients appeared to have been receiving GLM-IV in accordance with Food and Drug Administration labeling; although the rate of prescribing methotrexate was low, dosages and administration intervals were within the expected ranges.

Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective.

OBJECTIVE: To examine reasons why rheumatoid arthritis patients discontinued subcutaneous (SQ) anti-tumor necrosis factor (anti-TNF) treatment in the past 12 months, so as to help inform successful, uninterrupted therapy. METHODS: Data were collected in March and April 2011 using self-reported, internet-based questionnaires. Study inclusion criteria comprised: rheumatoid arthritis diagnosis; discontinuation of SQ anti-TNF medication (adalimumab, certolizumab, etanercept, or golimumab) within the past 12 months; aged ≥18 years; United States residency; and consent to participate. Patients reported primary and other reasons for discontinuation of their most recently discontinued anti-TNF. RESULTS: Questionnaires from 250 patients were analyzed; 72.8% were female, 80.8% were white, and median age was 51 years. Patients had discontinued etanercept (n=109), adalimumab (n=98), certolizumab (n=24), or golimumab (n=19) within the past 12 months. When prompted about their primary reason for discontinuation, lack of effectiveness (40.8%) was cited most often, followed by injection experience (18.4%). Combining prompted primary and other reasons for discontinuation, 60.8% of patients reported lack of effectiveness, while 40.8% reported injection experience, which included: pain/burning/discomfort after injection (14.4%); pain/burning/discomfort during injection (13.2%); injection reactions such as redness/swelling after injection (12.4%); dislike of self-injection (11.6%); dislike of frequency of injection (10.4%); and fear of injection/needles (6.8%). CONCLUSION: From the patient perspective, there are unmet needs with regard to the effectiveness and injection experience associated with SQ anti-TNF medications, which may lead to discontinuation. Treatment options with a better injection experience may address these needs. These results demonstrate the importance of including the patient perspective when making prescribing decisions or payer access and coverage decisions.

Quality process measures for rheumatoid arthritis: performance from members enrolled in a national health plan.

BACKGROUND: Health care quality problems are reflected in the underuse, overuse, and misuse of health care services. There is evidence suggesting that the quality of rheumatoid arthritis (RA) patient care is suboptimal, which has spurred the development of a number of systematic quality improvement metrics. OBJECTIVE: To investigate a quality process measurement set in a sample of commercially insured RA patients. METHODS: Medical, pharmacy, and laboratory claims for members with an RA diagnosis (ICD-9-CM 714.x) during calendar years 2008 through 2012 were extracted from the Optum Clinformatics Data Mart database. Eight process quality measures focused on RA patient response and tolerance to therapy were examined in the claims database. Measures were calculated for individual calendar years from 2009 to 2012, inclusive. RESULTS: The majority of adult RA patients received at least 1 prescription for a disease-modifying antirheumatic drug (DMARD) across the 4 measurement years: range = 78.5%-81.6%. Erythrocyte sedimentation rate and C-reactive protein testing were also evident in the majority of the sample, with 67.1%-72.2% of newly diagnosed RA patients receiving baseline testing, and 56.0%-58.7% of existing RA patients receiving annual testing. Among methotrexate users, liver function tests were performed in 74.5%-75.7% of treated patients, serum creatinine tests in 70.1%-72.6% of patients, and complete blood count tests in 74.5%-76.0% of patients. Additionally, most patients initiating a new DMARD had a claim for a baseline serum creatinine test (68.0%-70.3%) and baseline liver function test (69.3%-71.0%). CONCLUSIONS: Findings suggest that a majority of RA patients are attaining patient quality process measures, although a considerable proportion of patients (approximately 25%) may be receiving suboptimal care. Further studies are warranted to understand whether attainment of these measures translates into better outcomes.

Utilization and adherence patterns of subcutaneously administered anti-tumor necrosis factor treatment among rheumatoid arthritis patients.

BACKGROUND: Adherence to therapy is a key requirement underlying achievement of clinical outcomes in randomized controlled drug registration trials. In postmarketing studies, comparison of adherence among therapies can become more complicated when drug dosing and administration schedules differ or when methods used to measure adherence are not consistently applied. OBJECTIVE: The objective of this exploratory study was to investigate a broad range of utilization and adherence outcomes associated with subcutaneous biologic treatments for rheumatoid arthritis (RA). METHODS: Adult patients (aged ≥18 years) exhibiting ≥2 claims with an RA diagnosis (code 714.x), at least 24 months of continuous medical and pharmacy eligibility, and 30-day supplies of adalimumab, etanercept, or golimumab were selected from the Optum Insight Clinformatics database. Adherence and utilization measures were calculated and compared across treatment groups. RESULTS: A total of 1532 adalimumab, 2099 etanercept, and 261 golimumab patients met inclusion criteria. Compared with both adalimumab and etanercept patients, golimumab patients were significantly more likely to have a medication possession ratio of ≥0.80 (82% vs 71% vs 62%; P < 0.001) and significantly less likely to have ≥4 late medication refills (6.9% vs 17.7% vs 26.1%; P < 0.001 for all). Etanercept patients had significantly greater refill intervals (37.7 vs 34.9 and 35.1 days) and had the lowest proportion of adherent fills (70% vs 77% and 75%) compared with both golimumab and adalimumab patients (P < 0.001 for all). Bivariate effects were reproduced in multivariate models that controlled for treatment duration. CONCLUSIONS: A number of statistically significant medication adherence differences were observed among golimumab, adalimumab, and etanercept patients in treatment for RA. Overall, golimumab patients appeared to be the most adherent group. Findings may be partially attributable to golimumab patients' likely increased disease severity, their prior experience with biologic medication, or golimumab's once-monthly dosing schedule, which requires fewer administrations than both adalimumab and etanercept.

Comparative multidatabase analysis of dosing patterns and infusion intervals for the first 12 infliximab infusions in patients with rheumatoid arthritis.

BACKGROUND: According to prescribing information for rheumatoid arthritis (RA) treatments in the United States, infliximab should be administered at weeks 1, 2, 6, and then every 8 weeks starting at a 3-mg/kg dose, with flexible dosing up to 10 mg/kg and/or every 4 weeks based on clinical response. OBJECTIVE: This study evaluated dosing and intervals of the first 12 infliximab infusions in patients with RA across multiple large administrative databases. METHODS: Data were obtained from 4 databases: HealthCore Integrated Research Database (HIRD), IMS LifeLink Health Plan Claims Database (IMS Lifelink), Premier Perspective Database (PPD), and Wolters Kluwer Pharma Solutions (WKPS). Patients were aged ≥18 years, diagnosed with RA, and naive to biologic therapy. Patients with other select inflammatory conditions were excluded. The induction period included infusions 1 through 3; the maintenance period included infusions 4 through 12. RESULTS: Observed dosing patterns from the HIRD, IMS LifeLink, PPD, and WKPS databases demonstrated minimal dose increases from the first infusion (93.5, 103.3, 58.8, and 73.2 mg, respectively) and from the first maintenance infusion (69.1, 64.3, 45.7, and 45.7 mg, respectively) to the highest dose during the first 12 infusions. The mean number of days between infusions in the maintenance period ranged from 53.3 to 63.5 in HIRD, 53.7 to 60.3 in IMS LifeLink, 53.4 to 59.4 in PPD, and 52.3 to 55.0 in the WKPS database. CONCLUSION: Data from multiple databases of patients with RA suggest that, in clinical practice, infliximab dosing and intervals are consistent with FDA prescribing information and remain relatively stable during the first 12 infusions.

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.

The association between Alzheimer's disease symptom severity and caregiver outcomes: a cross-sectional study.

OBJECTIVE: To determine the association between Alzheimer's disease (AD) symptom severity and caregiver outcomes. METHOD: This was a database analysis of the Alzheimer's Disease Caregiver Study, a cross-sectional, caregiver-reported study conducted in 2007. Data were collected nationwide via the Internet and in 8 cities: Detroit, Michigan; Knoxville, Tennessee; Los Angeles, California; Miami, Florida; Philadelphia, Pennsylvania; Phoenix, Arizona; St Louis, Missouri; and Washington, DC. Participants were unpaid adult caregivers of AD patients (N = 1,077). Symptom severity was measured using the Revised Memory and Behavioral Problem Checklist (RMBPC). Caregiver outcomes included the Caregiver Burden Scale, diagnosis of anxiety and depression, use of the emergency room, hospitalization, number of physician visits, and missed workdays in the past 6 months. Linear and logistic regression models were developed to assess effects of AD symptom severity on outcomes. Covariates included caregiver and patient characteristics and interactions of AD symptom severity with covariates based on previous analyses. RESULTS: Of the 1,077 respondents, 1,034 had valid RMBPC overall symptom severity scores. AD symptom severity was a significant (P < .01) predictor of all caregiver outcomes except physician visits. Each unit increase in RMBPC severity score corresponded with an increase of 0.328 (95% CI, 0.101-0.554) units in caregiver burden. Each unit increase in severity resulted in increases in physician visits (b = 0.343; 95% CI, 0.052-0.635) and absenteeism (b = 1.722; 95% CI, 0.694-2.749). For each unit increase in RMBPC severity score, caregivers had greater likelihood of emergency room use (odds ratio = 1.506; 95% CI, 1.230-1.845), hospitalization (OR = 1.393; 95% CI, 1.091-1.777), anxiety (OR = 1.506; 95% CI, 1.257-1.805), and depression (OR = 1.811; 95% CI, 1.505-2.179). CONCLUSIONS: AD symptom severity is significantly associated with poorer caregiver outcomes. Therefore, treatments that slow AD symptom progression may be beneficial to caregiver outcomes.

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

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.