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Introduction: Improving real-world medication adherence to injectable antihyperglycemics in type 2 diabetes mellitus (T2DM) is a clinical challenge. Quantification of the level of adherence required to achieve a minimal clinically important difference (MCID) in glycemic control would assist in meeting this goal. The study objective was to review the literature regarding the relationships of medication adherence and persistence with health outcomes in adult T2DM patients using injectable antihyperglycemics. Methods: Systematic searches were conducted using electronic databases to identify publications over the last decade. Publications were screened against established eligibility criteria. Study data were extracted, evaluated, and used to identify strengths, limitations, and gaps in current evidence. Results: Eligibility criteria were met by 38 studies, and this report analyzed 34 studies related to glycemic control (n = 25), healthcare resource use (n = 9), and healthcare costs (n = 14). Eight of these studies examined adherence to glucagon-like peptide-1 receptor agonists (GLP-1 RA), including 1 study regarding adherence to GLP-1 RA or to insulin, and 1 study investigating a GLP-1 RA/insulin combination; the remaining studies involved insulin. Studies used a broad range of measures to classify adherence and persistence, and most measures were unable to reliably evaluate the complexities of patient behavior over time. Better adherence to injectable antihyperglycemic medications was generally found to be associated with improved glycemic control, although no studies attempted to identify a MCID. Although higher diabetes-related pharmacy and total healthcare costs were reported for adherent or persistent patients, these patients tended to have lower diabetes-related and all-cause medical costs. Conclusion: Results of this review confirmed the effectiveness of injectable antihyperglycemic medications for glycemic control, suggesting that there are clinical and financial consequences to nonadherence. Although attempts were made to quantify the effects of nonadherence, the interpretation of study results was limited by the lack of a MCID and inadequate study design. Funding: Novo Nordisk, Inc., Plainsboro Township, NJ, USA. Plain Language Summary: Plain language summary available for this article. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcomes and experiences (PRO) data are an integral component of health care quality measurement and PROs are now being collected by many healthcare systems. However, hospital organizational capacity-building for the collection and sharing of PROs is a complex process. We sought to identify the factors that facilitated capacity-building for PRO data collection in a nascent quality improvement learning collaborative of 16 hospitals that has the goal of improving the childbirth experience. Description: We used standard qualitative case study methodologies based on a conceptual framework that hypothesizes that adequate organizational incentives and capacities allow successful achievement of project milestones in a collaborative setting. The 4 project milestones considered in this study were: (1) Agreements; (2) System Design; (3) System Development and Operations; and (4) Implementation. To evaluate the success of reaching each milestone, critical incidents were logged and tracked to determine the capacities and incentives needed to resolve them. Assessment: The pace of the implementation of PRO data collection through the 4 milestones was uneven across hospitals and largely dependent on limited hospital capacities in the following 8 dimensions: (1) Incentives; (2) Leadership; (3) Policies; (4) Operating systems; (5) Information technology; (6) Legal aspects; (7) Cross-hospital collaboration; and (8) Patient engagement. From this case study, a trajectory for capacity-building in each dimension is discussed. Conclusion: The implementation of PRO data collection in a quality improvement learning collaborative was dependent on multiple organizational capacities for the achievement of project milestones. Significance: Patient-Reported Outcomes (PRO) are measures of a patient's health status. PROs are self-reported and do not require interpretation by the provider. PROs are being collected by many healthcare systems as a patient-centered approach to measuring and reporting healthcare quality. This case study outlines the critical issues involved in collecting PRO data and identifies the factors that facilitate capacity-building for PRO data collection. It provides an example of how the PRO data could be applied to improve patient satisfaction with the childbirth hospital experience. [ABSTRACT FROM AUTHOR]

Objectives The goals of interconception care are to optimize women's health and encourage adequate spacing between pregnancies. Our study calculated trends in interpregnancy interval (IPI) patterns and measured the association of differing intervals with birth outcomes in California. Methods Women with 'non-first birth' deliveries in California hospitals from 2007 to 2009 were identified in a linked birth certificate and patient discharge dataset and divided into three IPI birth categories: <6, 6-17, and 18-50 months. Trends over the study period were tested using the Cochran-Armitage two-sided linear trend test. Chi square tests were used to test the association between IPI and patient characteristics and selected singleton adverse birth outcomes. Results Of 645,529 deliveries identified as non-first births, 5.6 % had an IPI <6 months, 33.1 % had an IPI of 6-17 months, and 61.3 % had an IPI of 18-50 months. The prevalence of IPI <6 months declined over the 3-year period (5.8 % in 2007 to 5.3 % in 2009, trend p value <0.0001).Women with an IPI <6 months had a significantly higher prevalence of early preterm birth (<34 weeks), low birthweight (<2500 g), neonatal complications, neonatal death and severe maternal complications than women with a 6-17 month or 18-50 month IPI (p < 0.005). Comparing those with a 6-17 month vs 18-50 month IPI, there were increased early preterm births and decreased maternal complications, complicated delivery, and stillbirth/intrauterine fetal deaths among those with a shorter IPI. Conclusions for Practice In California, women with an IPI <6 months were at increased risk for several birth outcomes, including composite morbidity measures. [ABSTRACT FROM AUTHOR]

The tracking of elective deliveries (ED) prior to 39 gestational weeks has become a mandatory requirement for all hospitals with ≥1,100 deliveries for accreditation by The Joint Commission (TJC); however, the feasibility and accuracy of monitoring efforts remain problematic for many hospitals. Here, we evaluated the feasibility of three operational approaches to tracking ED. We used mixed methods to evaluate the feasibility of 3 different approaches to tracking ED: (1) using administrative data, (2) using electronic medical record (EMR) data, and (3) using targeted data collection in a county-wide quality improvement (QI) effort. For (1), we analyzed data from the California 2009 linked birth cohort dataset, and calculated hospital rates of ED using TJC technical specifications. For (2), we performed a case study of a project that recruited hospitals to provide EMR data for the TJC measure calculation. For (3), we performed a case study of a project that recruited hospitals to prospectively track elective inductions of labor. For (1), hospital discharge data were insufficient without supplementation from the EMR or birth certificate. For (2), legal and operational issues surrounding data sharing, and non-standardized data elements prohibited hospital participation. For (3), the QI approach successfully established policies and data collection systems yet lacked infrastructure to assure sustainability at a hospital or regional level. In summary, ED tracking required the coordination and support of multiple resources to enable hospitals to satisfactorily report on this measure. [ABSTRACT FROM AUTHOR]

Background and Objectives: The retrospective comparison of test and reference treatment arms in a randomized prospective clinical trial is potentially useful in economic modeling seeking to assess the cost effectiveness of alternative therapies. Methods: To enhance the credibility of such retrospective comparisons, we propose the application of the following adjustments to significance levels obtained from standard statistical methodology: (1) a significance test for the lower bound of the 95 % confidence interval for the observed difference, (2) a conservative Bonferroni method of adjustment for multiple comparisons, (3) an adjusted p-value calculated using Scheffe's single-step method, and (4) Bayesian 95 % credibility intervals with a prior centered at zero. Results: These adjustments were applied to data from a randomized double-blind concurrent trial (SPD489-325) that established the efficacy and safety of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Prospectively planned analyses demonstrated that the reduction in the symptoms of ADHD was significantly greater than placebo in patients treated with either LDX or the reference treatment, osmotic-release oral system methylphenidate (OROS-MPH). Retrospective analyses showed that the improvement in the symptoms of ADHD was greater in patients treated with LDX than OROS-MPH. We now show that this observation remained significant after the application of the four statistical penalties. Conclusions: By adjusting the significance level, it is possible to compare quantitatively such retrospective results with prospectively defined comparisons. However, the qualitative level of such retrospective evidence should remain secondary to that obtained from prospectively specified comparisons in a randomized clinical trial. [ABSTRACT FROM AUTHOR]

Background: With preliminary data suggesting an increasing trend in attention-deficit/hyperactivity disorder (ADHD) prevalence in Europe, the use of psychotropic medications in this population needs to be better understood, particularly among patients with ADHD and no co-morbid psychiatric disorder. Methods: Medical charts of patients aged 6–17 years with one or more ADHD diagnosis between January 1, 2004 and June 30, 2007, and use of ADHD medication were abstracted by physicians from six European countries. Patients with a history of epilepsy or diagnosis of Tourette syndrome were excluded. Results: Among a convenience sample of 569 children/adolescent patients (mean age, 12.1 years), 80 (14.1 %) patients used psychotropic concomitant medication (PCM) along with their current on-label ADHD medication. The number of pre-existing co-morbidities, high impairment due to the symptom of anger, and country (France; Italy; the Netherlands; and Spain vs. the reference country, Germany) were significantly associated with PCM use (UK was not significantly different vs. Germany). In particular, in France, Italy, the Netherlands, and Spain, PCM use was highest. Conclusions: These findings suggest that greater attention to the use of PCM, which are not indicated for the treatment of ADHD, may be warranted in children and adolescents receiving PCM. This highlights the need for further research to assess the impact of PCM use in ADHD patients and to consider alternative, individualized, indicated treatment strategies for patients with ADHD. [ABSTRACT FROM AUTHOR]

Background: In 2003, the Agency for Healthcare Quality and Research (AHRQ) published its Quality Indicators for healthcare, and set out methodological criteria for the evaluation of potential candidates. Objectives: Because perinatal infections may result from poor obstetrical practices, we intended to describe the variability of maternal and congenital neonatal infections across different types of hospital ownership (e.g., not for profit, government), and to assess whether rates of these infections meet criteria as quality indicators. Research Design: Population-based cohort study. Subjects: All laboring women without maternal, fetal, or placental complications who delivered in California in 1997, and their neonates, as reported through hospital discharge data. Measures: A Bayesian hierarchical logistic regression model was used to quantify the effects of both “patient-level” risk factors such as parity and prior cesarean history, and “hospital-level” risk factors such as ownership and teaching status. Results: The 308,841 mother–newborn pairs in this low-risk study population delivered at 281 hospitals; 0.39% had uterine infections and 1.3% had neonatal infections. Hospital ownership and teaching status were strongly associated with perinatal infection. Secondly, methods used to estimate and analyze hospital-specific infection rates identified hospitals with exceptionally high rates. Twenty-eight hospitals had neonatal infection rates that ranged from 3% to 28%. Conclusions: The methods presented here were consistent with AHRQ methods and criteria for potential Quality Indicators. They also identified hospitals with exceptionally high rates of infectious morbidity. The relationship between hospital ownership and obstetrical practice patterns, and the feasibility of practice improvement, remain to be studied. [ABSTRACT FROM AUTHOR]

Objective: Because postpartum hemorrhage may result from factors related to obstetrical practice patterns, we examined the variability of postpartum hemorrhage and related risk factors (obstetrical trauma, chorioamnionitis, and protracted labor) across hospital types and hospitals in California. Methods: Linked birth certificate and hospital discharge data from 507,410 births in California in 1997 were analyzed. Cases were identified using International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) codes. Comparisons were made across hospital types and individual hospitals. Risk adjustments were made using 1) sample restriction to a subset of 324,671 low-risk women, and 2) Bayesian hierarchical logistic regression model to simultaneously quantify the effects of patient-level and hospital-level risk factors. Results: Postpartum hemorrhage complicated 2.4% of live births. The incidence ranged from 1.6% for corporate hospitals to 4.9% for university hospitals in the full sample, and from 1.4% for corporate hospitals to 3.9% for university hospitals in the low-risk sample. Low-risk women who delivered at government, HMO and university hospitals had two- to threefold increased odds (odds ratios 1.98 to 2.71; 95% confidence sets ranged from 1.52 to 4.62) of having postpartum hemorrhage compared to women who delivered at corporate hospitals, irrespective of patient-level characteristics. They also had significantly higher rates of obstetrical trauma and chorioamnionitis. Greater variations were observed across individual hospitals. Conclusion: The incidence of postpartum hemorrhage and related risk factors varied substantially across hospital types and hospitals in California. Further studies using primary data sources are needed to determine whether these variations are related to the processesof care. [ABSTRACT FROM AUTHOR]

Introduction: Suboptimal management of patients with chronic renal insufficiency (CRI) is thought to contribute to the high morbidity and early mortality seen after the onset of end-stage renal disease (ESRD), and may therefore impact on healthcare costs associated with patients with ESRD. The objective of this study was to investigate the effects of pre-dialysis patient care on hospital days during the 6 months after hemodialysis initiation. Study Design: Data were obtained from Group Health Cooperative in Seattle, Washington, USA, a staff model health management organization with an established, active, CRI management program, and were analyzed retrospectively. Patients who started long-term hemodialysis between 1 January 1997 and 31 January 2000, and who were referred to the Group Health Cooperative CRI management program, were included in the study. Methods: Demographic and baseline clinical characteristics, details of interventions received by patients prior to dialysis, and hemoglobin (Hb) levels during the 6 months prior to the onset of ESRD were recorded. The numbers of days that each patient spent in hospital during the baseline (1 year to 6 months pre-dialysis), pre-dialysis (180 days pre-dialysis), and post-dialysis initiation (180 days following dialysis initiation) periods were recorded. Hospital days during the post-dialysis initiation period were associated with patient characteristics and pre-dialysis interventions received, and were compared with national data from the US Renal Data System (USRDS). Results: When calculated similarly to data from the USRDS, the mean number of hospital days for patients in this study was lower than that for the national hemodialysis population (9.4 vs 13.9 days). Temporary vascular access and inadequate nephrology visits prior to dialysis were the key factors increasing the risk of a greater number of hospital days. The use of a catheter for initial dialysis significantly increased patients’ risk of hospital days compared with the use of a fistula or graft (median 4 vs 2 days; odds ratio [OR] 2.5); lack of pre-dialysis nephrology visits had a similar effect. Patients’ Hb levels prior to dialysis were also important: a clinically significant decrease in Hb levels (≥1 g/dL), or a decrease resulting in Hb levels <10 g/dL at dialysis initiation, increased hospital days (median 2 vs 3 days; OR 2.0). Conclusion: Early, active management of patients with CRI can reduce hospital days and associated costs in the early months after hemodialysis initiation. [ABSTRACT FROM AUTHOR]

Introduction: Patients with alopecia areata (AA) experience psychological and psychosocial symptoms including depression, anxiety, anger, social withdrawal, embarrassment, and low self-esteem. While multiple studies have measured the detrimental emotional impact of AA on patient quality of life, evidence of its effect on work productivity loss (WPL) and daily activities is limited. This study aimed to assess the extent of AA-related emotional symptom (ES) burden on work productivity and activity impairment. Methods: A cross-sectional survey of dermatologists and their adult patients with AA was conducted in the USA in 2019. Dermatologists provided assessments of patients' clinical characteristics, while patients completed sociodemographic questionnaires along with two validated patient-reported outcome measures of the Work Productivity and Activity Impairment (WPAI) and the AA Patient Priority Outcomes (AAPPO) ES subscale. The WPAI assessed AA-related WPL (employed respondents) and activity impairment (all respondents), and the AAPPO-ES assessed AA-related frequency of feeling self-conscious, embarrassed, sad, or frustrated. Multiple linear regression models were fitted to both WPAI scores with the AAPPO ES as an independent variable. Results: A total of 242 patients with a mean (SD) age of 39.2 (13.3) years, treated by 59 dermatologists, were evaluated. Mean (SD) ES score was 2.0 (1.1). Mean (SD) work productivity loss [n = 170] and activity impairment [n = 242] were 12.2% (17.4%) and 13.3% (18.3%), respectively. After adjusting for covariates, WPL increased by 4.1% [95% confidence interval (CI) 1.6–6.7%; p = 0.002] and activity impairment increased by 3.1% (95% CI 0.7–5.4%; p = 0.010) for every 1-point increase in ES. For an average patient, a 1-SD decrease (about 1 point) on the ES scale substantially reduced WPL and activity impairment (by at least 25%). Conclusions: Patients with AA reported significant increases in WPL and activity impairment associated with worsening AA-related ES. These findings underscore the substantial emotional and psychosocial burden among patients with AA and a need for improved treatment options. [ABSTRACT FROM AUTHOR]

Introduction: A potentially elevated risk for pulmonary thrombosis with Janus kinase inhibitors (JAKinibs) was identified, as well as an increased risk for portal vein thrombosis, in ruxolitinib patients. Consequently, the objective of this investigation was to repeat a comprehensive analysis of the US FDA's Adverse Event Reporting System (FAERS) database to assess postmarketing reporting rates of thromboembolic events (TEs) in patients treated with JAKinibs.Methods: FAERS data (1 January 2010 to 30 September 2019) were searched for reports of all FDA-approved JAKinibs across all indications. For each drug-adverse drug reaction (ADR) pair, the reporting odds ratio (ROR) [two-sided 95% confidence interval (CI)] and empirical Bayesian geometric mean (EBGM) [one-sided 95% lower bound] were calculated to detect drug-ADR pairs with higher-than-expected reporting rates within the FAERS. Significance was declared when both lower 95% CI bounds were > 1.Results: Significantly elevated reporting rates of pulmonary thrombosis were evident with tofacitinib (ROR 2.36 [1.69-3.31]; EBGM 2.01 [1.53]), as was pulmonary embolism with baricitinib (ROR 12.23 [8.35-17.89]; EBGM 7.72 [3.82]) and portal vein thrombosis with ruxolitinib (ROR 4.16 [2.70-6.40]; EBGM 4.52 [3.11]). Deep vein thrombosis reports were increased with baricitinib (ROR 14.84 [9.64-22.84]; EBGM 9.49 [5.91]), as was thrombosis with ruxolitinib (ROR 1.40 [1.20-1.63]; EBGM 1.72 [1.52]). The relationship between the time of treatment initiation and event occurrence indicated that time to events occurred randomly.Conclusions: This study found significant reporting rates for TEs in patients treated with JAKinibs across brands and indications, providing additional evidence that JAKinibs may be contraindicated in patients at risk of TEs. [ABSTRACT FROM AUTHOR]

The objective of this study is to explore the associations between the patient-reported Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17) in order to facilitate clinical decision-making. An integrated efficacy dataset of three randomized placebo-controlled trials (NCT02614547, NCT02942004, and NCT02942017) evaluating brexanolone injection, a neuroactive steroid chemically identical to allopregnanolone, in women with postpartum depression was used for this post hoc analysis. Data were pooled across treatment arms. Associations were assessed at day 30 (end-of-trial follow-up). Pearson correlation assessed the relationship between EPDS and PHQ-9 item and total scores and HAMD-17 total score. Cohen's kappa assessed agreement of EPDS remission (score < 10) and PHQ-9 remission (score < 5) with HAMD-17 remission (score ≤ 7). Ordinary least squares (OLS) regression models were used to develop equations estimating HAMD-17 total scores from EPDS and PHQ-9 scores, respectively. The total scores showed large correlations (HAMD-17/EPDS: r = 0.71, p < 0.001; HAMD-17/PHQ-9: r = 0.75, p < 0.001). Individual EPDS and PHQ-9 items significantly correlated (r= 0.35 to 0.67, all p < 0.001) with HAMD-17 total score. EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%. OLS models yielded the following equations: HAMD-17 total = 2.66 + (EPDS total × 0.87) and HAMD-17 total = 3.99 + (PHQ-9 total × 0.97). There were large and statistically significant associations between patient-reported outcomes (EPDS, PHQ-9) and clinician-reported outcomes (HAMD-17) as clinical improvements were associated with patient-reported symptom improvement. These results provide tools to help translate clinical trial data to clinical practice, thus aiding shared decision-making for this critical population. [ABSTRACT FROM AUTHOR]

This study was a retrospective chart review performed to examine and describe physician practice patterns in managing attention deficit/hyperactivity disorder (ADHD) across Europe. Physicians treating ADHD in the UK, France, Germany, Italy, the Netherlands and Spain were recruited. Each physician abstracted medical records of five patients (aged 6-17 years at time of review) with a documented diagnosis of ADHD made between January 2004 and June 2007. Data provided by the physician via the abstraction included (a) physician characteristics, (b) patient characteristics, (c) ADHD diagnosis and (d) ADHD outcomes (adherence, symptom control and satisfaction). A total of 779 patients met study inclusion criteria. In the overall population, patients' mean (SD) age at time of diagnosis was 8.9 (2.6) years. The predominant treatment choice was long-acting methylphenidate, which was prescribed to more than 56 % of patients. According to physicians, only 30.8 % of patients showed 'complete symptom control' on current treatment and only 31.8 % of physicians reported being 'very satisfied' with their patients' current treatment. Physicians' assessments of complete symptom control and physician satisfaction with treatment were low, indicating unmet needs with current ADHD management in Europe. [ABSTRACT FROM AUTHOR]

A response from the authors of the article "Management of ADHD in children across Europe: patient demographics, physician characteristics, and treatment patterns" in a 2013 issue is presented.