Randomized Controlled Trial of Twin-Twin Transfusion Syndrome Laser Surgery: The Sequential Trial.

BACKGROUND: Intraoperative blood transfer between twins during laser surgery for twin-twin transfusion syndrome (TTTS) can vary by surgical technique and has been proposed to explain differences in donor twin survival. OBJECTIVE: This trial compared donor twin survival with 2 laser techniques: the sequential technique, in which the arteriovenous communications from the volume-depleted donor to the volume-overloaded recipient are laser-occluded before those from recipient to donor; and the selective technique, in which the occlusion of the vascular communications is performed in no particular order. STUDY DESIGN: A single-center, open-label, randomized controlled trial was conducted in which TTTS patients were randomized to sequential versus selective laser surgery. Nested within the trial, a second trial randomized patients with superficial anastomoses (arterioarterial and venovenous) to ablation of these connections first (before ablating the arteriovenous anastomoses) versus last. The primary outcome measure was donor twin survival at birth. RESULTS: A total of 642 patients were randomized. Overall donor twin survival was similar between the 2 groups (85.6% [274/320] versus 84.2% [271/322], OR 1.12 [0.73-1.73], P=.605). Superficial anastomoses occurred in 27.6% (177/642) of cases. Donor survival was lower in the superficial anastomosis group versus those with only arteriovenous communications (70.6% [125/177] versus 90.3% [420/465], aOR 0.33 [0.20-0.54], P<.001). In cases with superficial anastomoses, donor survival was independent of timing of ablation or surgical technique. The postoperative mean middle cerebral artery (MCA) peak systolic velocity (PSV) was lower in the sequential vs selective group (1.00 ± 0.30 versus 1.06 ± 0.30 MoM, P=.003). Post hoc analyses showed 2 factors that were associated with poor overall donor twin survival: the presence/absence of donor twin preoperative critical abnormal Doppler (CAD) parameters and the presence/absence of arterioarterial anastomoses (AA). Depending on these factors, 4 categories of patients resulted: (1) Category 1 (54%, 347/642), no donor twin CAD + no AA: donor twin survival was 91.2% in the sequential and 93.8% in the selective groups; (2) Category 2 (22%, 143/642), CAD present + no AA: donor survival was 89.9% versus 75.7%; (3) Category 3 (11%, 73/642), no CAD + AA present: donor survival was 94.7% versus 74.3%; and (4) Category 4 (12%, 79/642), CAD present + AA present: donor survival was 47.6% versus 64.9%. CONCLUSION: Donor twin survival did not differ between the sequential versus selective laser techniques, and did not differ if superficial anastomoses were ablated first versus last. The donor twin's postoperative MCA PSV was improved with the sequential versus the selective approach. Post hoc analyses suggest that donor twin survival may be associated with the choice of laser technique according to high-risk factors. Further study is needed to learn if using these categories to guide the choice of surgical technique will improve outcomes. TRIAL REGISTRATION: NCT02122328 with no external funding.

Real-world reporting rates of administration-site reactions with on-demand treatment of hereditary angioedema attacks.

Background: Hereditary angioedema (HAE) is characterized by recurrent and unpredictable episodes of subcutaneous and/or submucosal swelling. Objective: To characterize the real-world treatment burden associated with existing on-demand therapies, we analyzed administration-site adverse drug reactions (ADR) associated with approved on-demand HAE therapies reported in the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Methods: We searched the FAERS database from October 1, 2009, to March 31, 2022, for reports of all FDA-approved on-demand therapies for HAE: plasma-derived C1-inhibitor (pdC1-INH), ecallantide, icatibant, and recombinant C1-inhibitor (rhC1-INH). ADRs in which the drug was listed as the "primary suspect" were recorded for each drug. ADR preferred terms were grouped into 18 ADR domains based on semantic and/or clinical similarity, and the number of reports for each drug was calculated per year from the time of approval through March 2022, and descriptive results were presented. Preferred terms associated with administration-site ADRs identified from clinical trials and denoted on approved HAE drug U.S. package inserts were examined in a complementary analysis. Results: The highest reported rates of administration-site ADRs per year were site pain (17.9 reports per year), site erythema (7.4 per year), and site swelling (6.7 per year). RhC1-INH was the only drug for which access-site complications and/or malfunctions were reported (9.5 per year). PdC1-INH had the highest rate of incorrect route of product administration (3.7 per year). PdC1-INH showed statistically significant elevated reporting rate of injection-site reactions (reporting odds ratio [ROR] 3.59 [2.36-5.46]; empirical Bayesian geometric mean [EBGM] 1.97 [1.39]). Icatibant and rhC1-INH showed a statistical trend toward an increased reporting rate of administration-site reactions. Conclusion: Real-world data from FAERS were generally consistent with adverse events reported in clinical trials and suggest that patients experience substantial treatment burden associated with FDA-approved parenteral on-demand therapies for HAE attacks. It should be noted that ADR rates are not exposure adjusted and are based on spontaneous reporting.

Capacity-Building for Collecting Patient-Reported Outcomes and Experiences (PRO) Data Across Hospitals.

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.

Associations between commonly used patient-reported outcome tools in postpartum depression clinical practice and the Hamilton Rating Scale for Depression.

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.

Caregiver Burden Due to Pulmonary Exacerbations in Patients with Cystic Fibrosis.

OBJECTIVE: To describe the poorly understood burden of pulmonary exacerbations experienced by primary caregivers of children (aged 2-17 years) with cystic fibrosis (CF), who frequently require prolonged hospitalizations for treatment of pulmonary exacerbations with intravenous (IV) antibiotics. STUDY DESIGN: In this prospective observational study, 88 caregivers in Germany, Ireland, the United Kingdom, and the US completed a survey during pulmonary exacerbation-related hospitalizations (T1) and after return to a "well state" of health (T2). The impact of pulmonary exacerbations on caregiver-reported productivity, mental/physical health, and social/family/emotional functioning was quantified. RESULTS: Primary caregivers of children with CF reported significantly increased burden during pulmonary exacerbations, as measured by the 12-item Short-Form Health Survey mental health component and the Work Productivity and Activity Impairment: Specific Health Problem absenteeism, presenteeism, work productivity loss, and activity impairment component scores. Compared to the "well state," during pulmonary exacerbations-related hospitalization caregivers reported lower physical health scores on the Child Health Questionnaire-Parent Form 28. Quality-of-life scores on the Caregiver Quality of Life Cystic Fibrosis scale and total support score on the Multidimensional Scale of Perceived Social Support did not differ significantly between T1 and T2. More caregivers reported a negative impact on family/social/emotional functioning during pulmonary exacerbations than during the "well state." CONCLUSIONS: Pulmonary exacerbations necessitating hospitalization impose a significant burden on primary caregivers of children with CF. Preventing pulmonary exacerbations may substantially reduce this burden.

Childbirth-specific patient-reported outcomes as predictors of hospital satisfaction.

BACKGROUND: Under value-based payment programs, patient-reported experiences and outcomes can impact hospital and physician revenue. To enable obstetrical providers to improve the childbirth experience, a framework for understanding what women expect and desire during childbirth is needed. OBJECTIVE: The purpose of this study was to identify key predictors of childbirth hospital satisfaction with the use of the Childbirth Experiences Survey. STUDY DESIGN: This study builds on a larger effort that used Patient-Reported Outcomes Management Information System methods to develop a childbirth-specific preliminary patient-reported experiences and outcomes item bank. These efforts led to the development of an antepartum and postpartum survey (Childbirth Experiences Survey Parts 1 and 2). All phases of the study were conducted with the participation of a community-based research team. We conducted a prospective observational study using national survey response panels that was organized through Nielsen to identify women's antepartum values and preferences for childbirth (Childbirth Experiences Survey Part 1). Eligible participants were pregnant women in the United States (English or Spanish speaking) who were ≥18 years old and ≥20 weeks pregnant. Women were recontacted and invited to participate in a postpartum follow-up survey to collect information about their childbirth patient-reported experiences and outcomes, which included childbirth satisfaction (Childbirth Experiences Survey Part 2). In bivariate analyses, we tested whether predisposing conditions (eg, patient characteristics or previous experiences), values and preferences, patient-reported experiences and outcomes, and the "gaps" between values and preferences and patient-reported experiences and outcomes were predictors of women's satisfaction with hospital childbirth services. Multivariable logistic regression models were fitted to examine the simultaneous effect of predictors on hospital satisfaction, which were adjusted for key predisposing conditions. RESULTS: From 500 women who anticipated a vaginal delivery at the time of the antepartum survey, who labored before delivery, and who answered the postpartum survey, key findings included the following responses: (1) the strongest predictors of women's satisfaction with hospital childbirth services were items in the domains of staff communication, compassion, empathy, and respect, and (2) 23 childbirth-specific patient-reported experiences and outcomes were identified. Examples of these patient-reported experiences and outcomes (such as being told about progress in labor and being involved in decisions regarding labor pain management) appeared especially relevant to women who experienced childbirth. A final model that predicted women's satisfaction with hospital childbirth services included a total of 8 items that could be optimized by doctors, midwives, and hospitals. These included the patient's report of how well she coped with labor pain, whether the hospital provided adequate space and food for their support person, and whether she received practical support for feeding the newborn infant. CONCLUSION: This study identified 23 childbirth-specific patient-reported experiences and outcomes that were predictors of childbirth hospital satisfaction. The implementation of the Childbirth Experiences Survey Parts 1 and 2 in a multihospital setting may lead to the development of childbirth hospital performance measures and strategies for improvement of the childbirth experience.

Patient-reported outcomes in patients with cystic fibrosis with a G551D mutation on ivacaftor treatment: results from a cross-sectional study.

BACKGROUND: Clinical studies demonstrate that ivacaftor (IVA) improves health-related quality of life (HRQoL) in patients aged ≥6 years with cystic fibrosis (CF). The real-world impact of IVA and standard of care (SOC) in groups of patients with G551D and F508del mutations, respectively, was assessed using a survey comprising disease-specific and generic HRQoL measures. METHODS: Patients with CF aged ≥12 years, or aged 6-11 years with caregiver support, with either (1) a G551D mutation and receiving IVA (G551D/IVA) for ≥3 months, or (2) homozygous for F508del and receiving SOC before lumacaftor/IVA availability (F508del/SOC), were eligible to participate in a cross-sectional survey. Demographic and clinical characteristics, and HRQoL measures were compared between patient groups, and multiple regression analyses were conducted. RESULTS: After differences in patient demographic and clinical characteristics were controlled for, significantly better scores were observed in the G551D/IVA group than in the F508del/SOC group on multiple domains of the validated Cystic Fibrosis Questionnaire-Revised and the EuroQol 5-dimensions 5-level questionnaire. CONCLUSIONS: G551D/IVA patients reported better HRQoL than F508del/SOC patients on generic and disease-specific measures in a real-world setting.

Factors associated with pain severity, pain interference, and perception of functional abilities independent of joint status in US adults with hemophilia: Multivariable analysis of the Pain, Functional Impairment, and Quality of Life (P-FiQ) study.

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.

Reliability and validity of patient-reported outcome instruments in US adults with hemophilia B and caregivers in the B-HERO-S study.

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.

Health-related quality of life in prisoners with attention-deficit hyperactivity disorder and head injury.

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.

The economic consequences of attention-deficit hyperactivity disorder in the Scottish prison system.

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.

Health-related quality of life with hereditary angioedema following prophylaxis with subcutaneous C1-inhibitor with recombinant hyaluronidase.

BACKGROUND: To estimate health-related quality-of-life changes in patients with hereditary angioedema due to C1-inhibitor (C1-INH) deficiency who received subcutaneous C1-INH with recombinant hyaluronidase (rHuPH20) for attack prophylaxis in a randomized, double-blind, dose-ranging, cross-over study. METHODS: Patients with type I/II hereditary angioedema received 1000 U of C1-INH with 24,000 U of rHuPH20 or 2000 U of C1-INH with 48,000 U of rHuPH20 every 3-4 days for 8 weeks and then crossed over for another 8-week period. The study was terminated early as a precaution related to non-neutralizing antibodies to rHuPH20. The Angioedema Quality of Life questionnaire (AE-QoL) was administered at weeks 1 and 5 of both periods, and at 1 week after the second treatment period. Changes in AE-QoL scores were calculated over both treatment periods and within each treatment period for patients with ≥4 weeks of treatment. RESULTS: Forty-one patients had evaluable AE-QoL data, and 22 patients completed treatment. At screening, 43% of the patients were receiving intravenous C1-INH. A significant average AE-QoL total score decline (improvement) of -8.1 (95% confidence interval, -13.7 to -2.5) was observed from baseline to the end of the study, and significant AE-QoL score declines were observed in the Functioning, Fear/Shame, and Nutrition domains. Patients on 2000 U reported higher mean AE-QoL score declines in Functioning and Nutrition domains relative to the 1000 U dose. Overall, 43.9% of all the patients, 45.5% of the study completers, and 46.7% of the nonprophylaxis users at baseline on high treatment doses achieved a reduction in the AE-QoL total score of six points. CONCLUSION: Despite early termination and prestudy prophylactic intravenous C1-INH use by 43% of the patients, improved AE-QoL scores were observed after ≤16 weeks of subcutaneous C1-INH-rHuPH20 prophylaxis.

Interpregnancy Interval and Childbirth Outcomes in California, 2007-2009.

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.

Cross-sectional survey of California childbirth hospitals: implications for defining maternal levels of risk-appropriate care.

OBJECTIVE: Measures of maternal mortality and severe maternal morbidity have risen in the United States, sparking national interest regarding hospitals' ability to provide maternal risk-appropriate care. We examined the extent to which hospitals could be classified by increasingly sophisticated maternal levels of care. STUDY DESIGN: We performed a cross-sectional survey to identify hospital-specific resources and classify hospitals by criteria for basic, intermediate, and regional maternal levels of care in all nonmilitary childbirth hospitals in California. We measured hospital compliance with maternal level of care criteria that were produced via consensus based on professional standards at 2 regional summits funded by the March of Dimes through a cooperative agreement with the Community Perinatal Network in 2007 (California Perinatal Summit on Risk-Appropriate Care). RESULTS: The response rate was 96% (239 of 248 hospitals). Only 82 hospitals (34%) were classifiable under these criteria (35 basic, 42 intermediate, and 5 regional) because most (157 [66%]) did not meet the required set of basic criteria. The unmet criteria preventing assignment into the basic category included the ability to perform a cesarean delivery within 30 minutes 100% of the time (only 64% met), pediatrician availability day and night (only 56% met), and radiology department ultrasound capability within 12 hours (only 83% met). Only 29 of classified hospitals (35%) had a nursery or neonatal intensive care unit level that matched the maternal level of care, and for most remaining hospitals (52 of 53), the neonatal intensive care unit level was higher than the maternal care level. CONCLUSION: Childbirth services varied widely across California hospitals, and most hospitals did not fit easily into proposed levels. Cognizance of this existing variation is critical to determining the optimal configuration of services for basic, intermediate, and regional maternal levels of care.

Variation in childbirth services in California: a cross-sectional survey of childbirth hospitals.

OBJECTIVE: The objective of the study was to describe the resources and activities associated with childbirth services. STUDY DESIGN: We adapted models for assessing the quality of healthcare to generate a conceptual framework hypothesizing that childbirth hospital resources and activities contributed to maternal and neonatal outcomes. We used this framework to guide development of a survey, which we administered by telephone to hospital labor and delivery nurse managers in California. We describe the findings by hospital type (ie, integrated delivery system [IDS], teaching, and other [community] hospitals). RESULTS: Of 248 nonmilitary childbirth hospitals in California, 239 (96%)responded; 187 community, 27 teaching, and 25 IDS hospitals reported. The context of services varied across hospital types, with community hospitals more likely to have for-profit ownership, be in a rural or isolated location, and have fewer annual deliveries per hospital. Results included the findings of the following: (1) 24 hour anesthesia availability in 50% of community vs 100% of IDS and teaching hospitals (P < .001); (2) 24 hour in-house labor and delivery physician coverage in 5% of community vs 100% of IDS and 48% of teaching hospitals (P < .001); (3) 24 hour blood bank availability in 88% of community vs 96% of IDS and 100% of teaching hospitals (P = .092); (4) adult subspecialty intensive care unit availability in 33% of community vs 36% of IDS and 82% of teaching hospitals (P < .001); (5) ability to perform emergency cesarean delivery in 30 minutes 100% of the time in 56% of community vs 100% of IDS and 85% of teaching hospitals (P < .001); (6) pediatric care available both day and night in 54% of community vs 63% of IDS vs 76% of teaching hospitals (P = .087); and (7) no neonatal intensive care unit in 44% of community vs 12% of IDS and 4% of teaching hospitals (P < .001). CONCLUSION: Childbirth services varied widely across California hospitals. Cognizance of this variation and linkage of these data to childbirth outcomes should assist in the identification of key resources and activities that optimize the hospital environment for pregnant women and set the groundwork for identifying criteria for the provision of maternal risk-appropriate care.

Do laborists improve delivery outcomes for laboring women in California community hospitals?

OBJECTIVE: We sought to determine the impact of the laborist staffing model on cesarean rates and maternal morbidity in California community hospitals. STUDY DESIGN: This is a cross-sectional study comparing cesarean rates, vaginal birth after cesarean rates, composite maternal morbidity, and severe maternal morbidity for laboring women in California community hospitals with and without laborists. We conducted interviews with nurse managers to obtain data regarding hospital policies, practices, and the presence of laborists, and linked this information with patient-level hospital discharge data for all deliveries in 2012. RESULTS: Of 248 childbirth hospitals, 239 (96.4%) participated; 182 community hospitals were studied, and these hospitals provided 221,247 deliveries for analysis. Hospitals with laborists (n = 43, 23.6%) were busier, had more clinical resources, and cared for higher-risk patients. There was no difference in the unadjusted primary cesarean rate for laborist vs nonlaborist hospitals (11.3% vs 11.7%; P = .382) but there was a higher maternal composite morbidity rate (14.4% vs 12.0%; P = .0006). After adjusting for patient and hospital characteristics, there were no differences in laborist vs nonlaborist hospitals for any of the specified outcomes. Hospitals with laborists had higher attempted trial of labor after cesarean rates, and lower repeat cesarean rates (90.9% vs 95.9%; P < .0001). However, among women attempting trial of labor after cesarean, there was no difference in the vaginal birth after cesarean success rate. CONCLUSION: We were unable to demonstrate differences in cesarean and maternal childbirth complication rates in community hospitals with and without laborists. Further efforts are needed to understand how the laborist staffing model contributes to neonatal outcomes, cost and efficiency of care, and patient and physician satisfaction.

The Feasibility of Tracking Elective Deliveries Prior to 39 Gestational Weeks: Lessons From Three California Projects.

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.

Improving hospital patient falls: leveraging staffing characteristics and processes of care.

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.

Monitoring childbirth morbidity using hospital discharge data: further development and application of a composite measure.

OBJECTIVE: The purpose of this study was to evaluate the use of a childbirth composite morbidity indicator for monitoring childbirth morbidity at hospital and regional levels in California. STUDY DESIGN: Study data were obtained from the 2005 linked maternal and neonatal discharge dataset for California hospitals. The study population was limited to laboring women with singleton, term (≥37 weeks' gestation), inborn, and live births. Women with and without pregnancy complications were stratified into high- and low-risk groups. The composite outcome was defined as any significant morbidity of the mother or newborn infant during the childbirth admission. Submeasures for maternal and neonatal composite morbidity and for severe maternal morbidity were examined with both aggregate and hospital-level analyses. RESULTS: Of 377,869 eligible deliveries, 120,218 (31.8%) were categorized as high risk and 257,651 (68.2%) were categorized as low risk. High-risk women had higher morbidity rates for all comparisons. The mean childbirth composite morbidity rate was 21% overall: 28% for high-risk women and 18% for low-risk women. For high- and low-risk strata, the rates of maternal complications were 18% and 13%, and the rates of severe maternal morbidity were 1.4% and 0.5%, respectively. There was substantial variation across hospitals for all measures. CONCLUSION: The childbirth composite morbidity rate is designed to report childbirth complication rates that combine maternal and neonatal morbidity. This measure and its submeasures met the criteria for quality indicator evaluation as specified by the Agency for Healthcare Research and Quality and can be used for benchmarking or for monitoring childbirth outcomes at regional levels.

Trends in maternal morbidity before and during pregnancy in California.

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.