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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]

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]

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]

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]

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]

Abstract: Background: This study was designed to assess changes in brain volume and cognitive abilities in memantine-treated patients with Alzheimer’s disease (AD) by using an exploratory, single-arm, delayed-start design. Methods: Cholinesterase inhibitor-treated patients with AD (N = 47; Mini-Mental State Examination score range: 15–23) were enrolled in an observational lead-in period (weeks: 1–24), followed by an open-label period of add-on memantine treatment (weeks: 25–48). The patients underwent magnetic resonance imaging at weeks 0 (baseline), 24 (immediately before memantine initiation), and 48 (endpoint), and a battery of neuropsychological tests at weeks 0, 24, 28, 36, and 48. The primary outcome measure was the annualized rate of change (%) in total brain volume (TBV) between the two study periods. Data were analyzed using paired t-tests. Results: There were no statistically significant differences in the rates of change in TBV, ventricular volume, or left hippocampal volume between the study periods; however, the memantine treatment period was associated with a significantly slower right hippocampal atrophy (−5.5% ± 12.0% vs −10.8% ± 7.2%; P = .038). Memantine treatment was also associated with superior performances on the Boston Naming Test (P = .034) and the Trail Making Test, Part B (P = .001), but also with a higher number of errors (i.e., repetitions and intrusions) on the California Verbal Learning Test. Memantine was found to be safe and well tolerated. Conclusions: In this study, no difference in the rates of TBV change between the two periods was observed; however, memantine treatment was found to be associated with slowing of right hippocampal atrophy, and with improvement on one test of executive functioning as well as a test of confrontation naming ability. Trials using structural magnetic resonance imaging and a delayed-start design may be a feasible option for the assessment of treatments for AD. [Copyright &y& Elsevier]