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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]

Objective: To develop a conceptual framework and preliminary item bank for childbirth-specific patient-reported outcome (PRO) domains.Data Sources: Women, who were U.S. residents, ≥18 years old, and ≥20 weeks pregnant, were surveyed regarding their childbirth values and preferences (V&P) using online panels.Study Design: Using community-based research techniques and Patient-Reported Outcomes Management Information System (PROMIS® ) methodology, we conducted a comprehensive literature review to identify self-reported survey items regarding patient-reported V&P and childbirth experiences and outcomes (PROs). The V&P/PRO domains were validated by focus groups. We conducted a cross-sectional observational study and fitted a multivariable logistic regression model to each V&P item to describe "who" wanted each item.Principal Findings: We identified 5,880 V&P/PRO items that mapped to 19 domains and 58 subdomains. We present results for the 2,250 survey respondents who anticipated a vaginal delivery in a hospital. Wide variation existed regarding each V&P item, and personal characteristics, such as maternal confidence and ability to cope well with pain, were frequent predictors in the models. The resulting preliminary item bank consisted of 60 key personal characteristics and 63 V&P/PROs.Conclusions: The conceptual framework and preliminary (PROMIS® ) item bank presented here provide a foundation for the development of childbirth-specific V&P/PROs. [ABSTRACT FROM AUTHOR]

Objective: To use population data to identify patient characteristics associated with a postpartum maternal emergency department visit within 90 days of discharge after birth.Methods: This retrospective cross-sectional study analyzed linked maternal discharge and emergency department data for all live California births from 2009 to 2011. The primary outcome was at least one emergency department visit within 90 days of hospital discharge after birth. Secondary outcomes included three or more visits within 90 days ("high utilization") and inpatient readmission. Independent variables included demographics (age, race or ethnicity, payer, income) and clinical characteristics (length of stay, antepartum complications, mode of delivery, and severe maternal morbidity at delivery). Multilevel logistic regression identified variables associated study outcomes; we validated the predictive model with a split-sample approach and receiver operating characteristic curve analysis.Results: Of 1,071,232 deliveries included, 88,674 women (8.3%) visited the emergency department at least once in the 90 days after delivery discharge. Emergency department use was significantly associated with Medicaid insurance (adjusted odds ratio [OR] 2.15, 95% CI 2.08-2.21), age younger than 20 years (adjusted OR 2.08, 95% CI 1.98-2.19), severe maternal morbidity at delivery (adjusted OR 1.58, 95% CI 1.49-1.71), antepartum complications (adjusted OR 1.46, 95% CI 1.42-1.50), and cesarean delivery (adjusted OR 1.40, 95% CI 1.37-1.44). Approximately one fifth of visits occurred within 4 days of discharge, and more than half were within 3 weeks. High utilizers comprised 0.5% of the entire sample (5,171 women) and only 1.2% of women presenting for emergency department care were readmitted. Receiver operating curve model analysis using the validation sample supported predictive accuracy for postpartum emergency department use (area under the curve=0.95).Conclusion: One in 12 California women visited the emergency department in the first 90 days after postpartum discharge. Women at increased risk for postpartum emergency department use per our validated model (eg, low income, birth complications) may benefit from earlier scheduled postpartum visits. [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]

Background: Burden on caregivers of children/adolescents with attention-deficit/hyperactivity disorder (ADHD) is multidimensional, but incompletely understood. Objective: To analyze caregiver burden across the concepts of work, social/family life, and parental worry/stress, in relation to selected contributing factors. Methods: The online Caregiver Perspective on Pediatric ADHD survey was fielded in ten European countries. Analysis included children/adolescents (6-17 years) who were receiving/had received ADHD pharmacotherapy in the previous 6 months. Caregivers recorded their child's/adolescent's symptoms "on"/"off" medication (ie, when the caregiver reported that the child/adolescent forgot/chose not to take medication, before the onset of medication effect, or medication worn off). Effects of ADHD severity, comorbidities, and medication adherence on each burden outcome were assessed (multiple regression models). Results: In total, 2,326 caregivers were included (children/adolescents' mean age: 11.5 years, 80% male). Caregivers reported missed/altered work, avoiding social activity, increased parental worry/stress, and strain on family life, despite using ADHD pharmacotherapy. Child/adolescent comorbidities and ADHD severity were significantly related to all burden concepts measured; the strongest comorbidity associations were with altered work (odds ratios [ORs] =1.68 [95% confidence interval {CI} 1.33, 2.12], 1.87 [1.37, 2.54], 3.47 [2.51, 4.78] for 1, 2, 3+ comorbidities, respectively) and planning the day around the child/adolescent (OR =1.42 [95% CI 1.17, 1.72], 1.73 [1.33, 2.15], 2.65 [1.99, 3.53]); the strongest severity associations were: quitting a job (OR =1.41 [95% CI 1.26, 1.59]) and planning a day around the child/adolescent (OR =1.26 [95% CI 1.20, 1.32]). Increased medication adherence was most associated with reducing the caregiver burden for altered work (OR =0.57 [95% CI 0.45, 0.72]), worrying about how they are being perceived as a parent (OR =0.68 [0.56, 0.83]), and avoiding social activity (OR =0.56 [0.45, 0.68]), but not family or stress burden. Conclusion: Burdens related to work, social activity, family life, and parental worry/stress were experienced by the caregivers of children/adolescents with ADHD, despite using ADHD pharmacotherapy. Better understanding of clinical/treatment characteristics most associated with the components of caregiver burden may help improve ADHD management and may ease caregiver burden. [ABSTRACT FROM AUTHOR]

The caregiver perspective on pediatric attention-deficit/hyperactivity disorder (ADHD) study (CAPPA) was a web-based, cross-sectional survey of caregivers of children and adolescents (6-17 years of age) with ADHD and was conducted in 10 European countries. CAPPA included caregiver assessments of global medication satisfaction, global symptom control, and satisfaction with ADHD medication attributes. Overall, 2,326 caregiver responses indicated that their child or adolescent was currently receiving ADHD medication and completed the "off medication" assessment required for inclusion in the present analyses. Responses to the single-item global medication satisfaction question indicated that 88% were satisfied (moderately satisfied to very satisfied) with current medication and 18% were "very satisfied" on the single-item question. Responses to the single-item global symptom control question indicated that 47% and 19% of caregivers considered their child or adolescent's symptoms to be "controlled" or "very well controlled", respectively. Significant variations in response to the questions of medication satisfaction and symptom control were observed between countries. The correlation between the global medication satisfaction and global symptom control questions was 0.677 (P<0.001). Global medication satisfaction was significantly correlated (P<0.001) with all assessed medication attributes, with the highest correlations observed for symptom control (r=0.601) and effect duration (r=0.449). Correlations of medication attributes with global symptom control were generally lower than with global medication satisfaction but were all statistically significant (P<0.001). CAPPA medication satisfaction and symptom control were also significantly correlated (P<0.001) with symptom control as based on the ADHD-Rating Scale-IV symptom score and the number of bad days per month when on medication. In conclusion, caregiver responses in this European sample suggest that current treatment could potentially be improved. The observed correlations of global medication satisfaction with global symptom control and other CAPPA assessments, including medication attributes, provide support for the inter-connectivity of the medication satisfaction and symptom control. [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]

Objectives. We examined trends in maternal comorbidities in California. Methods. We conducted a retrospective cohort study of 1 551 017 California births using state-linked vital statistics and hospital discharge cohort data for 1999, 2002, and 2005. We used International Classification of Diseases, Ninth Revision, Clinical Modification codes to identify the following conditions, some of which were preexisting: maternal hypertension, diabetes, asthma, thyroid disorders, obesity, mental health conditions, substance abuse, and tobacco use. We estimated prevalence rates with hierarchical logistic regression models, adjusting for demographic shifts, and also examined racial/ethnic disparities. Results. The prevalence of these comorbidities increased over time for hospital admissions associated with childbirth, suggesting that pregnant women are getting sicker. Racial/ethnic disparities were also significant. In 2005, maternal hypertension affected more than 10% of all births to non-Hispanic Black mothers; maternal diabetes affected nearly 10% of births to Asian/Pacific Islander mothers (10% and 43% increases, respectively, since 1999). Chronic hypertension, diabetes, obesity, mental health conditions, and tobacco use among Native American women showed the largest increases. Conclusions. The prevalence of maternal comorbidities before and during pregnancy has risen substantially in California and demonstrates racial/ethnic disparity independent of demographic shifts. [ABSTRACT FROM AUTHOR]

Objectives. We examined trends in maternal comorbidities in California. Methods. We conducted a retrospective cohort study of 1 551 017 California births using state-linked vital statistics and hospital discharge cohort data for 1999, 2002, and 2005. We used International Classification of Diseases, Ninth Revision, Clinical Modification codes to identify the following conditions, some of which were preexisting: maternal hypertension, diabetes, asthma, thyroid disorders, obesity, mental health conditions, substance abuse, and tobacco use. We estimated prevalence rates with hierarchical logistic regression models, adjusting for demographic shifts, and also examined racial/ethnic disparities. Results. The prevalence of these comorbidities increased over time for hospital admissions associated with childbirth, suggesting that pregnant women are getting sicker. Racial/ethnic disparities were also significant. In 2005, maternal hypertension affected more than 10% of all births to non-Hispanic Black mothers; maternal diabetes affected nearly 10% of births to Asian/Pacific Islander mothers (10% and 43% increases, respectively, since 1999). Chronic hypertension, diabetes, obesity, mental health conditions, and tobacco use among Native American women showed the largest increases. Conclusions. The prevalence of maternal comorbidities before and during pregnancy has risen substantially in California and demonstrates racial/ethnic disparity independent of demographic shifts. [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 We propose a methodology for identifying and analysing 'elective' preterm births ( PTBs) using administrative data, and apply this methodology to California data with the objective of providing a framework to further explore the potential rationales for early delivery. Methods Using the California linked birth cohorts for 1999, 2002 and 2005, singleton PTBs were identified using birth certificate gestational age ≥ 24 and <37 weeks. Through a hierarchical scheme that first removed cases with standard or 'hard' indications for early delivery (e.g. severe preeclampsia, placenta previa), cases of 'elective' PTB were identified with coding for medical intervention, that is, elective caesarean or labour induction. We calculated rates of elective PTB, with subanalyses of early (<34 weeks of gestational age) and late PTB (34 to <37 weeks of gestational age) using hierarchical logistic regression models. Results Of 1 387 565 singleton deliveries, 99 614 (7.2%) were preterm. Elective PTBs increased 27.7% over the 6-year study period, with nearly all cases confined to the late PTB stratum; elective late PTB rates rose from 10.5% to 13.5% of all late PTBs ( P < 0.0001). Indications for delivery in this Elective Group ('soft indications') included prior pelvic floor repair, mental health conditions, fetal anomalies, malpresentation and oligohydramnios. Six per cent of patients with a late PTB had a medical intervention with no hard or soft indication for delivery. Conclusions Using administrative data, we developed a method for identifying and trending the proportion of PTBs that is 'elective'. This method can be used to explore and monitor potential strategies for the prevention of elective PTB. [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]

Major depressive disorder (MDD) and postpartum depression (PPD) are disabling conditions. This integrated analysis of MDD and PPD clinical trials investigated the impact of zuranolone—a positive allosteric modulator of synaptic and extrasynaptic GABA A receptors and neuroactive steroid under investigation for adults with MDD and approved as an oral, once-daily, 14-day treatment course for adults with PPD in the US—on health-related quality of life, including functioning and well-being, as assessed using the 36-item Short Form Health Survey V2 (SF-36). Integrated data from 3 MDD (201B, MOUNTAIN, WATERFALL) and 1 PPD trial (ROBIN) for individual SF-36 domains were compared for zuranolone (30- and 50-mg) vs placebo at Day (D)15 and D42. Comparisons between zuranolone responders (≥50 % reduction from baseline in 17-item Hamilton Depression Rating Scale total score) and nonresponders were assessed. Overall, 1003 patients were included (zuranolone, n = 504; placebo, n = 499). Significant differences in change from baseline (CFB) to D15 for patients in zuranolone vs placebo groups were observed in 6/8 domains; changes were sustained or improved at D42, with significant CFB differences for all 8 domains. Zuranolone responders had significantly higher CFB scores vs nonresponders for all domains at D15 and D42 (p < 0.001). Two zuranolone doses were integrated across populations of 2 disease states with potential differences in functioning, comorbidities, and patient demographics. All p -values presented are nominal. Integrated data across 4 zuranolone clinical trials showed improvements in functioning and well-being across all SF-36 domains. Benefits persisted after completion of treatment course at D42. • Patients reported early and sustained improvements in functioning and well-being. • Health-related quality of life benefits extended beyond duration of zuranolone dosing. • A 14-day treatment course of zuranolone may address an unmet need for depression. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Levels of pain and dysfunction appear to differ among people with hemophilia despite similar levels of joint disease. Objective: To determine patient characteristics that influence pain and function independent of joint status. Methods: US adults with hemophilia completed a survey that included information on clinical characteristics, demographics, and patient‐reported outcome instruments assessing pain (Brief Pain Inventory v2 Short Form [BPI]), functional impairment (Hemophilia Activities List [HAL]), and health status (EQ‐5D‐5L). Additionally, physiotherapists optionally completed a clinical joint evaluation (Hemophilia Joint Health Score [HJHS]). Associations were examined using simple and multiple regression models. Results: Of 381 adults enrolled, 240 had complete HJHS scores (median age, 32 years). After controlling for HJHS and opiate use, anxiety/anxiolytic use was significantly associated with worse pain severity and interference scores. After controlling for HJHS, the most significant predictors of functional impairment were older age, unemployment, more severe hemophilia, and greater pain. EQ‐5D‐5L pain/discomfort was associated with worse outcomes on most HAL scores. Conclusion: Unemployment, anxiety, and depression were each associated with both greater pain and functional disability after controlling for joint status. Continued attention to pain and psychosocial issues will be important in improving clinical care and research efforts in the hemophilia population. [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]

OBJECTIVE: This study tested multivariate models exploring unit-level predictors of medication administration (MA) accuracy. BACKGROUND: During MA, nurses are both the last line of defense from medication-related errors and a potential perpetrator of error. Direct observation reveals safe practices and the accuracy of medication delivery. METHODS: Using a direct-observation, cross-sectional design, data submitted by 124 adult patient care units for 15 600 medication doses, from January 2009 to April 2010, were studied. RESULTS: Distractions and interruptions were the most common safe practice deviation. Characteristics of patient care units and RN hours of care affected nurses' safe practices and MA accuracy. Safe practices predict and mediate MA accuracy. A 5% decrease in safe practice deviations would reduce MA errors by 46% without any change in RN hours of care. CONCLUSION: Nurses' adherence to MA safe practices, combined with unit characteristics and staffing factors, has the potential to dramatically improve MA accuracy. [ABSTRACT FROM AUTHOR]

The study determines whether hospital-specific rates of gestational pyelonephritis may serve as a measure of the quality of ambulatory maternal care services in California. The rates of preterm birth and congenital neonatal infection were higher among pregnant women with pyelonephritis. Pregnant women on MediCal as payer have a higher risk because poverty may indirectly make them more physiologically vulnerable or because they receive suboptimal care.

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]

To evaluate the health-related quality of life (HRQoL) burden associated with postpartum depression (PPD), determine the extent to which clinical response impacts HRQoL, and estimate the impact of PPD and clinical response on healthcare resource utilization (HRU) and productivity. Patient data (n = 127) from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials evaluating the safety and efficacy of brexanolone injection in adults with PPD were employed for these posthoc analyses. HRQoL and health utility was assessed with the SF-36-v2 Health Survey (SF-36v2) acute version. The 17-item Hamilton Rating Scale for Depression (HAMD-17) total score was used to identify clinical response (≥50% reduction in HAMD-17 total score). Baseline HRQoL burden was assessed by comparison to age- and gender-adjusted population normative data from the 2009 QualityMetric PRO Norming study. The impact of clinical response was evaluated by comparing day 7 and day 30 SF-36v2 scores between clinical responders and non-responders. Interpretations of the meaningfulness of clinical response were indirectly estimated via 2017 National Health and Wellness Survey data linking SF-36v2 mental component summary (MCS) scores to (HRU) and productivity. Baseline HRQoL of patients with PPD was significantly below normative values. Day 7 and day 30 clinical response were associated with large and statistically significant improvements in HRQoL, greater likelihood of meeting SF-36v2 responder definitions, and reduced impairment. MCS levels corresponding to those observed in clinical responders were linked to lower HRU and productivity loss relative to non-responders. PPD places a substantial burden on HRQoL. Achievement of rapid clinical response (at day 7) and clinical response sustained several weeks following the end of treatment (day 30) led to significant improvement in HRQoL, suggesting the importance of identifying women with PPD and providing effective treatment options. [ABSTRACT FROM AUTHOR]

Background: Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two Phase 3 clinical trials. Materials and Methods: Data from the three trials were combined. PPD-specific 17-item Hamilton Rating Scale for Depression (HAMD-17) group-level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT]) were estimated and applied to differences in BRX versus placebo (PBO) at hour 60 (primary endpoint) and day 30 (end of trial follow-up). Likelihood of HAMD-17 response and remission and Clinical Global Impression of Improvement (CGI-I) response for BRX versus PBO were assessed at hour 60 and as sustained through day 30 using relative risk. Associated number needed to treat (NNT) and number needed to harm (NNH) values were also estimated. Results: Two-hundred nine patients were included. The average HAMD-17 MID estimate was −2.1; the least-squared mean difference between BRX and PBO exceeded this at hour 60 and day 30. Minimal, moderate, and large MCTs were estimated to be −9, −15, and −20 points, respectively. Significantly more BRX-treated than PBO-treated patients achieved minimal, moderate, and large change (all ps < 0.05) at hour 60 and large meaningful response at day 30 (p < 0.05). BRX-treated patients were more likely to sustain HAMD-17 remission and CGI-I response through day 30 versus PBO. NNTs ranged from 4 to 8, with NNH of 97. Conclusions: BRX provided meaningful changes relative to PBO, rapid (hour 60), and sustained improvements (day 30) in PPD symptoms, low NNT, and large NNH. These results may help inform treatment decision-making. Clinicaltrials.gov registration numbers: NCT02614547, NCT02942004, and NCT02942017. [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]

In this letter to the editor, we present results of claims data analysis. This claims data analysis supports a hypothesis that in patients with hereditary angioedema due to C1-esterase inhibitor (C1-INH) deficiency, the occurrence and/or symptomatology of coexisting autoimmune disease may be positively influenced by a replacement therapy with plasma derived C1-INH. [ABSTRACT FROM AUTHOR]

Objective: To assess the reliability and validity of six patient‐reported outcomes (PRO) instruments for evaluating health‐related quality of life in adults with mild‐severe hemophilia B and caregivers of children with hemophilia B, including affected women/girls. Methods: Adults with hemophilia B and caregivers completed separate online surveys containing several PRO instruments, which were administered to adult participants only (EQ‐5D‐5L, Brief Pain Inventory v2 Short Form, Hemophilia Activities List, and International Physical Activities Questionnaire), both adults and caregivers (Patient Health Questionnaire [PHQ‐9]), or caregivers only (Generalized Anxiety Disorder 7‐Item [GAD‐7] scale). Construct validity and item‐total correlation were assessed using Pearson product‐moment correlation, internal consistency was assessed using Cronbach's alpha coefficient, and known‐group validity was assessed by comparisons to self‐reported characteristics based on the Kruskal‐Wallis test. Results: Patient‐reported outcomes instruments generally showed satisfactory reliability for adults (n = 299) and caregivers (n = 150). In adults, PRO instruments generally showed high construct validity. Most PRO instruments showed expected significant differences among known groups for adults and caregivers. PHQ‐9 and GAD‐7 did not show significant differences among caregiver age groups. Conclusions: Patient‐reported outcomes instruments administered in B‐HERO‐S demonstrated reliability and validity in the broader population of adults with hemophilia B and caregivers when including all severities and genders. [ABSTRACT FROM AUTHOR]

Background: Attention-deficit hyperactivity disorder (ADHD) is highly prevalent amongst prison inmates and the criminal justice system (CJS) likely bears considerable costs for offenders with ADHD. We aimed to examine the relationship between ADHD and health-related quality of life (HRQoL) and quality-adjusted life years (QALY) amongst imprisoned adults; and to estimate the annual expenditure associated with ADHD status in prison. Methods: An observational study was performed in 2011–2013, at Porterfield Prison, Inverness, United Kingdom (UK). The all male sample included 390 adult prison inmates with capacity to consent and no history of moderate or severe intellectual disability. Participants were interviewed using the Diagnostic Interview for ADHD in Adults 2.0. The Health Utilities Index Mark 3 (HUI3) was used to measure health status, and to calculate attribute specific HRQoL scores and QALY. Health service utilisation was obtained through inspection of medical prison records. Inmates with ADHD were compared with inmates without ADHD. Results: Inmates with ADHD had significantly lower QALYs, with a clinically significant adjusted difference of 0.13. Psychiatric co-morbidity accounted for the variation of ADHD on the HUI3 emotion domain only. Medical costs for inmates with ADHD were significantly higher; and behaviour-related prison costs were similar to prisoners without ADHD, reflecting a low frequency of recorded critical incidents. Conclusions: ADHD may directly contribute to adverse health and quality of life through cognitive and executive function deficits, and co-morbid disorders. The extrapolation of conservative cost estimates suggests that the financial burden of medical and behavior-related prison care for inmates with ADHD in the UK is approximately £11.7 million annually. The reported cost estimates are conservative as there is great variability in recorded critical incidents in prisons. In turn, for some prison establishments the prison care costs associated with prisoners with ADHD may be considerably greater. [ABSTRACT FROM AUTHOR]

Background: Attention-deficit hyperactivity disorder (ADHD) and head injury (including traumatic brain injury (TBI)) manifest in high levels across prison samples and guidance from the National Institute for Health and Care Excellence notes that people with acquired brain injury may have increased prevalence of ADHD. We aimed to examine the association of ADHD with TBI and the impact of the association upon health-related quality of life (HRQoL) and service use among imprisoned adults. Methods: An observational study was performed in 2011–2013, at Porterfield Prison, Inverness, United Kingdom (UK). The all male sample included 390 adult prison inmates with capacity to consent and no history of moderate or severe intellectual disability. Head injury was measured with a series of self-reported questions, addressing history of hits to the head: frequency, severity, loss of consciousness (LOC), and sequelae. Participants were interviewed using the Diagnostic Interview for ADHD in Adults 2.0. The Health Utilities Index Mark 3 was used to measure health status, and to calculate attribute specific HRQoL and Quality-Adjusted Life Year (QALY) scores. Results: 72% of prisoners sampled reported at least one head injury in their lifetime. Among those, 70% of head injuries occurred before age 16 and 70% experienced LOC. Prisoners with ADHD were nearly twice more likely to have TBI. Prisoners with ADHD-only and ADHD with co-morbid TBI had significantly lower scores in several HRQoL attributes, compared with TBI only or the absence of either condition. Adjusted logistic regression models indicated an average reduction of 0.20 QALYs in inmates with ADHD-only and 0.30 QALY loss in those with ADHD with co-morbid TBI compared with inmates with neither condition. Conclusions: There is a robust association between ADHD and TBI, and ADHD with co-morbid TBI confers significantly greater impairment in terms of HRQoL. Managing the short and long-term consequences of TBI is essential to improving care for prisoners and to addressing the criminogenic factors related to them. [ABSTRACT FROM AUTHOR]

Background: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that affects the lives of patients and their families. The Caregiver Perspective on Paediatric ADHD (CAPPA) survey was conducted to evaluate the burden associated with ADHD in Europe and to identify unmet needs. Here, we describe sociodemographic and clinical characteristics, treatment use and impact of ADHD.Methods: The cross-sectional web-based CAPPA survey was fielded in 10 European countries among caregivers of children/adolescents (aged 6-17 years) with ADHD who were currently receiving or had received pharmacotherapy in the previous 6 months.Results: Data on 3688 completed CAPPA surveys were evaluated. Children/adolescents were diagnosed with ADHD at a mean age of 6.9 years; 80% were male. Most children/adolescents (56%) had undergone behavioural therapy. Overall, 78% of children/adolescents currently received ADHD pharmacotherapy; high rates of atypical antipsychotic use were reported in some countries. Overall, 23% of children/adolescents had repeated a school year and 4% had been expelled recently. Most caregivers (68-88%) reported difficulty with schoolwork, social interactions/activities and family relationships, even when the child/adolescent was receiving ADHD medication. Almost one third (31%) of caregivers felt the need to change employment status despite their child/adolescent receiving ADHD medication in 53% of these cases.Limitations: Information was reported by caregivers recruited through market research panels; reporting, recall and selection biases may be present.Conclusion: Variation across Europe was observed in characteristics of caregivers and children/adolescents with ADHD, and treatment use. Even with medication, ADHD compromised or negatively impacted caregivers' work and children/adolescents' schoolwork, their social interactions and family relationships. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Predictive models for falls, injury falls, and restraint prevalence were explored within nursing unit structures and processes of care. BACKGROUND: The patient care team is responsible for patient safety, and improving practice models may prevent injuries and improve patient safety. METHODS: Using unit-level self-reported data from 215 hospitals, falls, injury falls, and restraint prevalence were modeled with significant covariates as predictors. RESULTS: Fewer falls/injury falls were predicted by populations with fewer frail and at-risk patients, more unlicensed care hours, and prevention protocol implementation, but not staffing per se, restraint use, or RN expertise. Lower restraint use was predicted by fewer frail patients, shorter length of stay, more RN hours, more certified RNs, and implementation of fall prevention protocols. CONCLUSION: In the presence of risk, patient injuries and safety were improved by optimizing staffing skill mix and use of prevention protocols. [ABSTRACT FROM AUTHOR]

Objective This study modeled the predictive power of unit/patient characteristics, nurse workload, nurse expertise, and hospital-acquired pressure ulcer ( HAPU) preventive clinical processes of care on unit-level prevalence of HAPUs. Data Sources Seven hundred and eighty-nine medical-surgical units (215 hospitals) in 2009. Study Design Using unit-level data, HAPUs were modeled with Poisson regression with zero-inflation (due to low prevalence of HAPUs) with significant covariates as predictors. Data Collection/Extraction Methods Hospitals submitted data on NQF endorsed ongoing performance measures to CALNOC registry. Principal Findings Fewer HAPUs were predicted by a combination of unit/patient characteristics (shorter length of stay, fewer patients at-risk, fewer male patients), RN workload (more hours of care, greater patient [bed] turnover), RN expertise (more years of experience, fewer contract staff hours), and processes of care (more risk assessment completed). Conclusions Unit/patient characteristics were potent HAPU predictors yet generally are not modifiable. RN workload, nurse expertise, and processes of care (risk assessment/interventions) are significant predictors that can be addressed to reduce HAPU. Support strategies may be needed for units where experienced full-time nurses are not available for HAPU prevention. Further research is warranted to test these finding in the context of higher HAPU prevalence. [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]

We reviewed the risks and benefits of vaginal and cesarean delivery to help frame the inherent trade-offs that should be considered as part of the informed consent discussion between patients and providers. We performed a targeted literature review for common complications of childbirth. Approximately 30% of women will experience a maternal or neonatal complication during childbirth. Both cesarean and vaginal delivery is associated with well-known measurable short- and long-term maternal and neonatal complications and benefits. Childbirth is not risk free. There are data available that can guide the informed consent process with objective quantifiable data that patients and providers can use to weigh risks and benefits of delivery methods. [ABSTRACT FROM AUTHOR]

We reviewed the risks and benefits of vaginal and cesarean delivery to help frame the inherent trade-offs that should be considered as part of the informed consent discussion between patients and providers. We performed a targeted literature review for common complications of childbirth. Approximately 30% of women will experience a maternal or neonatal complication during childbirth. Both cesarean and vaginal delivery is associated with well-known measurable short- and long-term maternal and neonatal complications and benefits. Childbirth is not risk free. There are data available that can guide the informed consent process with objective quantifiable data that patients and providers can use to weigh risks and benefits of delivery methods. [ABSTRACT FROM AUTHOR]

The article discusses a study to determine the relationship between nurse staffing and adverse patient events at the shift level including falls, falls with injury and medication administration errors (MAE). The research team used a Military Nursing Outcomes Database (MilNOD) created from thirteen military hospitals to monitor nurse staffing, patient falls and medication errors, and other outcomes while using Bayesian hierarchical logistic regression modeling to determine associations between staffing and adverse events. Results indicated that the skill mix of registered nurses (RNs), total nursing care hours, and experience, measured by a proxy variable, were directly related to shift-level adverse events.

Objective. To examine the relationship between prolonged second stage and postpartum hemorrhage (PPH). Methods. We conducted a retrospective case-control study of all cases of PPH which occurred at four Southern California hospitals in 2003. Cases were identified by ICD-9 codes and confirmed by chart reviews, and non-cases were randomly selected as controls. The relationship between PPH and prolonged second-stage was examined using bivariate and multivariate analyses. Results. The sample consisted of 91 cases and 323 controls. Cases were significantly more likely than controls to have had a prolonged second stage of labor, over a range of definitions for PPH and prolonged second stage. In multivariable analyses, prolonged second stage was associated with greater than three-fold (OR = 3.35; 95% CI 1.22-9.19) increased risk for PPH. Conclusion. Prolonged second stage is an important risk factor for PPH. Close supervision is warranted for women with a prolonged second stage. [ABSTRACT FROM AUTHOR]

This article examines the impact of mandated nursing ratios in California on key measures of nursing quality among adults in acute care hospitals. This study is a follow-up and extension of our first analysis exploring nurse staffing and nursing-sensitive outcomes comparing 2002 pre-ratios regulation data to 2004 post-ratios regulation data. For the current study we used postregulation ratios data from 2004 and 2006 to assess trends in staffing and outcomes. Findings for nurse staffing affirmed the trends noted in 2005 and indicated that changes in nurse staffing were consistent with expected increases in the proportion of licensed staff per patient. This report includes an exploratory examination of the relationship between staffing and nursing-sensitive patient outcomes. However anticipated improvements in nursing-sensitive patient outcomes were not observed. This report contributes to the growing understanding of the impacts of regulatory staffing mandates on hospital operations and patient outcomes. [ABSTRACT FROM AUTHOR]

Chemotherapy used to treat lymphoma can cause severe neutropenia. Risk models have identified factors that predict neutropenia across all chemotherapy cycles. We used clinical information obtained during pretreatment evaluation to develop a predictive model for severe neutropenia in the first cycle of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy. This case series study included lymphoma patients receiving CHOP chemotherapy with or without rituximab who did not receive pre-emptive hematopoietic growth factor. Risk factors for neutropenia were identified from previously published models and included age ≥65 years, hypoalbuminemia, renal/cardiovascular disease, anemia, abnormal bone marrow and increased lactate dehydrogenase (LDH). A composite score equal to the number of pretreatment risk factors was used to predict severe neutropenia in cycle 1. Fifty-three percent of patients (47 of 89) had severe neutropenia, with 70% of first episodes occurring during cycle 1. Eighty-two percent of first-cycle, severe neutropenia events occurred in patients ≥65-years-old. In univariate analysis, age ≥65 years and increased baseline LDH were significantly associated with increased risk for severe neutropenia in cycle 1. In logistic regression modeling, the probability of severe neutropenia in cycle 1 increased as the number of pretreatment risk factors increased, with a one-unit increase in risk score resulting in a 2.3-fold increase in severe neutropenia. The study results suggest that data obtained before initiating CHOP-based chemotherapy can be used to identify those patients who are at risk for severe neutropenia in cycle 1. If validated, our model could be used to identify patients who would benefit from early use of growth factors. [ABSTRACT FROM AUTHOR]

We sought to identify risk factors associated with the time to febrile neutropenia in patients with intermediate-grade, non-Hodgkin's lymphoma (NHL) who were receiving treatment with CHOP chemotherapy. Data were collected from 12 community and academic oncology practices participating in the Oncology Practice Pattern Study between 1991 and 1999. We reviewed the medical records of 577 intermediate-grade NHL patients who received initial CHOP chemotherapy and evaluated risk factors associated with time to first febrile neutropenic event. A febrile neutropenic event was defined as a body temperature of >100.6°F and an ANC nadir <1000/mm 3 . A total of 160 patients experienced 224 febrile neutropenic events. The risk of febrile neutropenia was significantly associated with age ≥65 years ( p =0.001), cardiovascular disease ( p =0.020), renal disease ( p =0.006), baseline hemoglobin <12 g/dl ( p =0.018), >80% planned average relative dose intensity (ARDI; p =0.018 ), and no prophylactic colony-stimulating factor (CSF) use ( p =0.046). First febrile neutropenic events occurred by day 14 of cycle 1 in one-half of patients experiencing febrile neutropenia. In multivariate analysis, the risk of febrile neutropenia remained significantly associated with age ≥65 years ( HR=1.65, 95% CI: 1.18-2.32), renal disease ( HR=1.91, 95% CI: 1.10-3.30), cardiovascular disease ( HR=1.54, 95% CI: 1.02-2.33), baseline hemoglobin <12 g/dl ( HR=1.44, 95% CI: 1.04-2.00), >80% planned CHOP ARDI ( HR=2.41, 95% CI: 1.30-4.47), and no CSF prophylaxis ( HR=2.13, 95% CI: 1.20-3.76). Such a model may permit the identification of patients at greatest risk of febrile neutropenia and, therefore, candidates for the selective prophylactic use of the hematopoietic growth factors. [ABSTRACT FROM AUTHOR]

This study investigated the incidence of anemia in chemotherapy-treated intermediate-grade nonHodgkin's lymphoma (IGNHL) patients. A historic case series design was used. The study data were obtained from 12 oncology practices that participated in the Oncology Practice Pattern Study (OPPS). The analysis focused on 353 IGNHL patients with normal baseline (prechemotherapy) hemoglobin (Hb) (≥ 12.0 g/dL). These patients were treated with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone combination) therapy (at some point) from 1993 through 1999. Anemia was found to be prominent during chemotherapy. About 24% of the patients with a normal baseline Hb level dropped below 10.0 g/dL and 49% dropped to 10.0 -11.9 g/dL, at some point during chemotherapy. As anemia treatment data were unavailable, it is likely that some of these patients received therapy to boost their Hb levels, rendering our results conservative. A logistic regression model revealed that in patients with normal baseline Hb, age ≥ 60, female gender, lower baseline Hb level, and lymphoma histology classified as the Working Formulation (WF) E or H were significant predictors of a drop in Hb below 10.0 g/dL during chemotherapy. Chemotherapy-induced anemia is frequently observed in lymphoma patients. It is possible to identify adverse baseline patient characteristics associated with higher risk of chemotherapy-induced anemia and carefully monitor such patients. Additional studies in community oncology practice are warranted to validate these findings and improve our understanding of the problems of anemia in chemotherapy treated non-Hodgkin's lymphoma (NHL) patients. J Oncol Pharm Practice (2002) 8, 73-80. [ABSTRACT FROM AUTHOR]

Conclusions. Our study results support previous findings of a high prevalence of anemia in cancer patients before cytotoxic therapy and the adverse impact that baseline anemia has on response to chemotherapy. [ABSTRACT FROM AUTHOR]

Examines the incidence of anemia among women treated with doxorubicin and cyclophosphamide chemotherapy for early stage of breast cancer. Importance of monitoring the hemoglobin levels of women; Factors contributing ot the severity of anemia; Myelosuppressive characteristics of chemotherapy regimen.

Introduction: For prophylaxis of hereditary angioedema (HAE) attacks, replacement therapy with human C1-inhibitor (C1-INH) treatment is approved and available as intravenous [C1-INH(IV)] (Cinryze®) and subcutaneous [C1-INH(SC)] HAEGARDA® preparations. In the absence of a head-to-head comparative study of the two treatment modalities, an indirect comparison of data from 2 independent but similar clinical trials was undertaken. Methods: Two similar randomized, double-blind, placebo-controlled, crossover studies were identified which evaluated either C1-INH(SC) (COMPACT; NCT01912456; 16 weeks) or C1-INH(IV) (CHANGE; NCT01005888; 14 weeks) vs. placebo (on-demand treatment only) for routine prevention of HAE attacks. Individual patient data from each trial were used to conduct an indirect comparison of treatment effects. Attack reductions (absolute and percent of mean/median number of monthly HAE attacks reduction over placebo) were compared between the two C1-INH formulations at approved/recommended doses: C1-INH(SC) 60 IU/kg twice weekly (n = 45) and 1000 U of C1-INH(IV) twice weekly (n = 22). Point estimates were adjusted using mixed and quantile regression models that controlled for study design. Results: The absolute mean monthly numbers of HAE attack reductions were 3.6 (95% CI 2.9, 4.2) for C1-INH(SC) 60 IU/kg vs. placebo and 2.3 (1.4, 3.3) for C1-INH(IV) vs. placebo; between-product difference, 1.3 (0.1, 2.4; P = 0.034). The mean percent reduction in monthly attack rate was significantly greater with C1-INH(SC) as compared with C1-INH(IV) (84% vs. 51%; P < 0.001). The percentages of subjects experiencing ≥ 50%, ≥ 70%, and ≥ 90% reductions in monthly HAE attack rates versus placebo were significantly higher with C1-INH(SC) 60 IU/kg as compared to C1-INH(IV) 1000 U (≥ 50% reduction: 91% vs. 50%, odds ratio [OR] = 10.33, P = 0.003; ≥ 70% reduction: 84% vs. 46%, OR = 6.19, P = 0.005; ≥ 90% reduction: 57% vs. 18%, OR = 6.04, P = 0.007). Conclusion: Within the limitations of an indirect study comparison, this analysis suggests greater attack reduction with twice-weekly C1-INH(SC) 60 IU/kg as compared to twice-weekly C1-INH(IV) 1000 U for the routine prevention of HAE attacks. [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.

Objective: To estimate the effect of memantine discontinuation for a nonmedical reason (eg, formulary restriction or family decision) on the health status of nursing home (NH) residents with Alzheimer's disease (AD). Design: Retrospective chart review. Setting: NHs (n = 113) in the United States. Participants: Residents (minimum stay of 90 days) with AD, continuously treated with memantine (MC: n = 273) or discontinued for 60 days or longer (MD: n = 248). The subset of patients who discontinued for a nonmedical reason (MD-N: n = 163) was also analyzed, as was the subset of patients in groups MC and MD-N whose doses of concomitant medications remained stable (MCs: n = 185; MD-Ns: n = 70). Measurements: Thirty-one common geriatric and AD symptoms from NH charts were scored based on their emergence or resolution (+1 or –1 points, respectively), worsening or improvement (+0.5 or –0.5 points, respectively), or absence of change (0 points), compared with the baseline period (the first 30 days analyzed in the charts, during which all residents received memantine treatment). Patients' weight change was also captured. Results: Compared with continuous treatment, memantine discontinuation was associated with a significant increase in the Total AD Symptom Change Score (ie, worsening) in all comparison pairs (MC versus MD, MC versus MD-N, and MCs versus MD-Ns: P < .001 for all). The symptoms showing greatest worsening aggregated into two factors: cognition and mood. Conclusion: Memantine discontinuation in NH residents with AD may be associated with declining health status, and should be considered with care. A randomized, placebo-controlled trial of treatment discontinuation is merited. [Copyright &y& Elsevier]