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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., Author(s): Samia Saeb [sup.1] , Lisa M. Korst [sup.2] , Moshe Fridman [sup.2] , Jeanette McCulloch [sup.3] , Naomi Greene [sup.1] , Kimberly D. Gregory [sup.1] Author Affiliations: (1) grid.50956.3f, [...]

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.

ObjectiveThis 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 sourcesSeven hundred and eighty-nine medical-surgical units (215 hospitals) in 2009.Study designUsing 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 methodsHospitals submitted data on NQF endorsed ongoing performance measures to CALNOC registry.Principal findingsFewer 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).ConclusionsUnit/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.

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. [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:, Author(s): Flojaune Griffin Cofer[sup.1] , Moshe Fridman[sup.2] , Elizabeth Lawton[sup.1] , Lisa M. Korst[sup.3] , Lisa Nicholas[sup.5] , Kimberly D. Gregory[sup.4] [sup.5] [sup.6] Author Affiliations: (1) Maternal, Child and Adolescent [...]

The tracking of elective deliveries (ED) prior to 39 gestational weeks has become a mandatory requirement for all hospitals with [greater than or equal to]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. Electronic supplementary material The online version of this article (doi:10.1007/s10995-015-1725-y) contains supplementary material, which is available to authorized users., Author(s): Lisa M. Korst[sup.1] , Moshe Fridman[sup.2] , Melanie Estarziau[sup.3] , Kimberly D. Gregory[sup.4] [sup.5] , Connie Mitchell[sup.6] Author Affiliations: (1) Childbirth Research Associates, North Hollywood, CA, USA (2) AMF [...]