Former NICU Families Describe Gaps in Family-Centered Care.

Care and outcomes of infants admitted to neonatal intensive care vary and differences in family-centered care may contribute. The objective of this study was to understand families' experiences of neonatal care within a framework of family-centered care. We conducted focus groups and interviews with 18 family members whose infants were cared for in California neonatal intensive care units (NICUs) using a grounded theory approach and centering the accounts of families of color and/or of low socioeconomic status. Families identified the following challenges that indicated a gap in mutual trust and power sharing: conflict with or lack of knowledge about social work; staff judgment of, or unwillingness to address barriers to family presence at bedside; need for nurse continuity and meaningful relationship with nurses and inconsistent access to translation services. These unmet needs for partnership in care or support were particularly experienced by parents of color or of low socioeconomic status.

Reduction in racial disparities in severe maternal morbidity from hemorrhage in a large-scale quality improvement collaborative.

BACKGROUND: Eliminating persistent racial/ethnic disparities in maternal mortality and morbidity is a public health priority. National strategies to improve maternal outcomes are increasingly focused on quality improvement collaboratives. However, the effectiveness of quality collaboratives for reducing racial disparities in maternity care is understudied. OBJECTIVE: To evaluate the impact of a hemorrhage quality-improvement collaborative on racial disparities in severe maternal morbidity from hemorrhage. STUDY DESIGN: We conducted a cross-sectional study from 2011 to 2016 among 99 hospitals that participated in a hemorrhage quality improvement collaborative in California. The focus of the quality collaborative was to implement the national maternal hemorrhage safety bundle consisting of 17 evidence-based recommendations for practice and care processes known to improve outcomes. This analysis included 54,311 women from the baseline period (January 2011 through December 2014) and 19,165 women from the postintervention period (October 2015 through December 2016) with a diagnosis of obstetric hemorrhage during delivery hospitalization. We examined whether racial/ethnic-specific severe maternal morbidity rates in these women with obstetric hemorrhage were reduced from the baseline to the postintervention period. In addition, we conducted Poisson Generalized Estimating Equation models to estimate relative risks and 95% confidence intervals for severe maternal morbidity comparing each racial/ethnic group with white. RESULTS: During the baseline period, the rate of severe maternal morbidity among women with hemorrhage was 22.1% (12,002/54,311) with the greatest rate observed among black women (28.6%, 973/3404), and the lowest among white women (19.8%, 3124/15,775). The overall rate fell to 18.5% (3553/19,165) in the postintervention period. Both black and white mothers benefited from the intervention, but the benefit among black women exceeded that of white women (9.0% vs 2.1% absolute rate reduction). The baseline risk of severe maternal morbidity was 1.34 times greater among black mothers compared with white mothers (relative risk, 1.34; 95% confidence interval, 1.27-1.42), and it was reduced to 1.22 (1.05-1.40) in the postintervention period. Sociodemographic and clinical factors explained a part of the black-white differences. After controlling for these factors, the black-white relative risk was 1.22 (95% confidence interval, 1.15-1.30) at baseline and narrowed to 1.07 (1.92-1.24) in the postintervention period. Results were similar when excluding severe maternal morbidity cases with transfusion alone. After accounting for maternal risk factors, the black-white relative risk for severe maternal morbidity excluding transfusion alone was reduced from a baseline of 1.33 (95% confidence interval, 1.16-1.52) to 0.99 (0.76-1.29) in the postintervention period. The most important clinical risk factor for disparate black rates for both severe maternal morbidity and severe maternal morbidity excluding transfusion alone was cesarean delivery, potentially providing another opportunity for quality improvement. CONCLUSION: A large-scale quality improvement collaborative reduced rates of severe maternal morbidity due to hemorrhage in all races and reduced the performance gap between black and white women. Improving access to highly effective treatments has the potential to decrease disparities for care-sensitive acute hospital-focused morbidities.

Improving Maternal Safety at Scale with the Mentor Model of Collaborative Improvement.

BACKGROUND: Obstetric safety bundles, consisting of action steps shown to improve outcomes, have been developed to address the most common and preventable causes of maternal morbidity and mortality. Implementing these best practices across all birthing facilities remains an important and challenging clinical and public health priority. METHODS: The California Maternal Quality Care Collaborative (CMQCC) developed an innovative external mentor model for large-scale collaborative improvement in which participating organizations were subdivided into small teams of six to eight hospitals, led by a paired dyad of physician and nurse leaders. The mentor model preserves the active sharing that enhances improvement across a large group of facilities working on the same project while enabling individualized attention to teams. The mentor model was tested by implementing the obstetric hemorrhage safety bundle (which consists of 17 key practices in four domains) in multiple California hospitals. RESULTS: A total of 126 hospitals were engaged to simultaneously implement the safety bundle. The adoption rates for the recommended practices in the four action domains were (1) Readiness, 78.9%; (2) Recognition and Prevention, 76.5%; (3) Response, 63.1%; and (4) Reporting and Systems Learning, 58.7%. Mentors (31/40) and participating teams (48 responses from 39/126 hospitals) provided feedback in an exit survey. Among the respondents, 64.5% of mentors and 72.9% of participants agreed that compared to a traditional collaborative structure, the mentor model was better suited for quality improvement at scale. CONCLUSION: The mentor model was successful in providing individualized support to teams and enabled implementation of the hemorrhage safety bundle across a diverse group of 126 hospitals.

Never judge a book by its cover: how NICU evaluators reach conclusions about quality of care.

OBJECTIVE: To identify key features in the NICU care delivery context that influence quality of care delivery. STUDY DESIGN: Qualitative study using in-depth, semi-structured interviews with 10 NICU quality experts with extensive experience conducting NICU site visits and evaluating quality of care. Analyses were performed using the method of constant comparison based on grounded theory. RESULTS: Qualitative analysis yielded three major themes: (1) the foundation for high quality care is a cohesive unit culture, characterized by open communication, teamwork, and engagement of families; (2) effective linkages between measurement and improvement action is necessary for continuous improvement; and (3) NICU capacity for improvement is sustained by active support, exchange of skills, and resources from the hospital. CONCLUSIONS: Team cohesion, engagement of families, culture of improvement supported by measurement and institutional support from the hospital are some of the key contextual and managerial features critical to high-quality NICU care.

Enabling health care decisionmaking through clinical decision support and knowledge management.

OBJECTIVES: To catalogue study designs used to assess the clinical effectiveness of CDSSs and KMSs, to identify features that impact the success of CDSSs/KMSs, to document the impact of CDSSs/KMSs on outcomes, and to identify knowledge types that can be integrated into CDSSs/KMSs. DATA SOURCES: MEDLINE(®), CINAHL(®), PsycINFO(®), and Web of Science(®). REVIEW METHODS: We included studies published in English from January 1976 through December 2010. After screening titles and abstracts, full-text versions of articles were reviewed by two independent reviewers. Included articles were abstracted to evidence tables by two reviewers. Meta-analyses were performed for seven domains in which sufficient studies with common outcomes were included. RESULTS: We identified 15,176 articles, from which 323 articles describing 311 unique studies including 160 reports on 148 randomized control trials (RCTs) were selected for inclusion. RCTs comprised 47.5 percent of the comparative studies on CDSSs/KMSs. Both commercially and locally developed CDSSs effectively improved health care process measures related to performing preventive services (n = 25; OR 1.42, 95% confidence interval [CI] 1.27 to 1.58), ordering clinical studies (n = 20; OR 1.72, 95% CI 1.47 to 2.00), and prescribing therapies (n = 46; OR 1.57, 95% CI 1.35 to 1.82). Fourteen CDSS/KMS features were assessed for correlation with success of CDSSs/KMSs across all endpoints. Meta-analyses identified six new success features: Integration with charting or order entry system. Promotion of action rather than inaction. No need for additional clinician data entry. Justification of decision support via research evidence. Local user involvement. Provision of decision support results to patients as well as providers. Three previously identified success features were confirmed: Automatic provision of decision support as part of clinician workflow. Provision of decision support at time and location of decisionmaking. Provision of a recommendation, not just an assessment. Only 29 (19.6%) RCTs assessed the impact of CDSSs on clinical outcomes, 22 (14.9%) assessed costs, and 3 assessed KMSs on any outcomes. The primary source of knowledge used in CDSSs was derived from structured care protocols. CONCLUSIONS: Strong evidence shows that CDSSs/KMSs are effective in improving health care process measures across diverse settings using both commercially and locally developed systems. Evidence for the effectiveness of CDSSs on clinical outcomes and costs and KMSs on any outcomes is minimal. Nine features of CDSSs/KMSs that correlate with a successful impact of clinical decision support have been newly identified or confirmed.

Effect of clinical decision-support systems: a systematic review.

BACKGROUND: Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. PURPOSE: To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. DATA SOURCES: MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. STUDY SELECTION: Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. DATA EXTRACTION: Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. DATA SYNTHESIS: 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n= 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n= 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n= 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. LIMITATIONS: Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. CONCLUSION: Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Dynamic interaction between breast cancer cells and osteoblastic tissue: comparison of two- and three-dimensional cultures.

Breast cancer cell colonization of osteoblast monolayers grown in standard tissue culture (2D) is compared to colonization of a multi-cell-layer osteoblastic tissue (3D) grown in a specialized bioreactor. Colonization of 3D tissue recapitulates events observed in clinical samples including cancer penetration of tissue, growth of microcolonies, and formation of "Single cell file" commonly observed in end-stage pathological bone tissue. By contrast, adherent cancer cell colonies did not penetrate 2D tissue and did not form cell files. Thus, it appears that 3D tissue is a more biologically (clinically) relevant model than 2D monolayers in which to study cancer cell interactions with osteoblastic tissue. This direct comparison of 2D and 3D formats is implemented using MC3T3-E1 murine osteoblasts and MDA-MB-231 human metastatic breast cancer cells, or the metastasis-suppressed line, MDA-MB-231BRMS1, for comparison. When osteoblasts were co-cultured with metastatic cells, production of osteocalcin (a mineralization marker) decreased and secretion of the pro-inflammatory cytokine IL-6 increased in both 2D and 3D formats. Cancer cell penetration of the 3D tissue coincided with a changed osteoblast morphology from cuboidal to spindle-shaped, and with osteoblasts alignment parallel to the cancer cells. Metastasis-suppressed cells did not penetrate 3D tissue, did not cause a change in osteoblast morphology or align in rows. Moreover, they proliferated much less in the 3D culture than in the 2D culture in a manner similar to their growth in bone. In both systems, the cancer cells proliferated to a greater extent with immature osteoblasts compared to more mature osteoblasts.

Osteogenesis in vitro: from pre-osteoblasts to osteocytes: a contribution from the Osteobiology Research Group, The Pennsylvania State University.

Murine calvariae pre-osteoblasts (MC3T3-E1), grown in a novel bioreactor, proliferate into a mineralizing 3D osteoblastic tissue that undergoes progressive phenotypic maturation into osteocyte-like cells. Initially, the cells are closely packed (high cell/matrix ratio), but transform into a more mature phenotype (low cell/matrix ratio) after about 5 mo, a process that recapitulates stages of bone development observed in vivo. The cell morphology concomitantly evolves from spindle-shaped pre-osteoblasts through cobblestone-shaped osteoblasts to stellate-shaped osteocyte-like cells interconnected by many intercellular processes. Gene-expression profiles parallel cell morphological changes, up-to-and-including increased expression of osteocyte-associated genes such as E11, DMP1, and sclerostin. X-ray scattering and infrared spectroscopy of contiguous, square centimeter-scale macroscopic mineral deposits are consistent with bone hydroxyapatite, showing that bioreactor conditions can lead to ossification reminiscent of bone formation. Thus, extended-term osteoblast culture (< or =10 mo) in a bioreactor based on the concept of simultaneous growth and dialysis captures the full continuum of bone development otherwise inaccessible with conventional cell culture, resulting in an in vitro model of osteogenesis and a source of terminally differentiated osteocytes that does not require demineralization of fully formed bone.

Metastatic breast cancer cells colonize and degrade three-dimensional osteoblastic tissue in vitro.

Metastatic breast cancer cells (BCs) colonize a mineralized three-dimensional (3D) osteoblastic tissue (OT) grown from isolated pre-osteoblasts for up to 5 months in a specialized bioreactor. Sequential stages of BC interaction with OT include BC adhesion, penetration, colony formation, and OT reorganization into "Indian files" paralleling BC colonies, heretofore observed only in authentic pathological cancer tissue. BCs permeabilize OT by degrading the extra-cellular collagenous matrix (ECM) in which the osteoblasts are embedded. OT maturity (characterized by culture age and cell phenotype) profoundly affects the patterns of BC colonization. BCs rapidly form colonies on immature OT (higher cell/ECM ratio, osteoblastic phenotype) but fail to completely penetrate OT. By contrast, BCs efficiently penetrate mature OT (lower cell/ECM ratio, osteocytic phenotype) and reorganize OT. BC colonization provokes a strong osteoblast inflammatory response marked by increased expression of the pro-inflammatory cytokine IL-6. Furthermore, BCs inhibit osteoblastic bone formation by down-regulating synthesis of collagen and osteocalcin. Results strongly suggest that breast cancer disrupts the process of osteoblastic bone formation, in addition to upregulating osteoclastic bone resorption as widely reported. These observations may help explain why administration of bisphosphonates to humans with osteolytic metastases slows lesion progression by inhibiting osteoclasts but does not bring about osteoblast-mediated healing.

Influence of substratum surface chemistry/energy and topography on the human fetal osteoblastic cell line hFOB 1.19: Phenotypic and genotypic responses observed in vitro.

Time-dependent phenotypic response of a model osteoblast cell line (hFOB 1.19, ATCC, and CRL-11372) to substrata with varying surface chemistry and topography is reviewed within the context of extant cell-adhesion theory. Cell-attachment and proliferation kinetics are compared using morphology as a leading indicator of cell phenotype. Expression of (alpha2, alpha3, alpha4, alpha5, alphav, beta1, and beta3) integrins, vinculin, as well as secretion of osteopontin (OP) and type I collagen (Col I) supplement this visual assessment of hFOB growth. It is concluded that significant cell-adhesion events-contact, attachment, spreading, and proliferation-are similar on all surfaces, independent of substratum surface chemistry/energy. However, this sequence of events is significantly delayed and attenuated on hydrophobic (poorly water-wettable) surfaces exhibiting characteristically low-attachment efficiency and long induction periods before cells engage in an exponential-growth phase. Results suggest that a 'time-cell-substratum-compatibility-superposition principle' is at work wherein similar bioadhesive outcomes can be ultimately achieved on all surface types with varying hydrophilicity, but the time required to arrive at this outcome increases with decreasing cell-substratum-compatibility. Genomic and proteomic tools offer unprecedented opportunity to directly measure changes in the cellular machinery that lead to observed cell responses to different materials. But for the purpose of measuring structure-property relationships that can guide biomaterial development, genomic/proteomic tools should be applied early in the adhesion/spreading process before cells have an opportunity to significantly remodel the cell-substratum interface, effectively erasing cause and effect relationships between cell-substratum-compatibility and substratum properties. IMPACT STATEMENT: This review quantifies relationships among cell phenotype, substratum surface chemistry/energy, topography, and cell-substratum contact time for the model osteoblast cell line hFOB 1.19, revealing that genomic/proteomic tools are most useful in the pursuit of understanding cell adhesion if applied early in the adhesion/spreading process.

Extended-term culture of bone cells in a compartmentalized bioreactor.

A specialized bioreactor is used to grow mineralizing, collagenous tissue up to 150 microm thick from an inoculum of isolated murine (mouse calvaria MC3T3-E1, American Type Culture Collection (ATCC) CRL-2593) or human (hFOB 1.19 ATCC CRL-11372) fetal osteoblasts over uninterrupted culture periods longer than 120 days (4 months). Proliferation and phenotypic progression of an osteogenic-cell monolayer into a tissue consisting of 6 or more cell layers of mature osteoblasts in the bioreactor was compared with cell performance in conventional tissue-culture polystyrene (TCPS) controls. Cells in the bioreactor basically matched results obtained in TCPS over a 15-day culture interval, but loss of insoluble extracellular matrix and an approximate doubling of apoptosis rates in TCPS after 30 days indicated that progressive instability of cultures maintained in TCPS with periodic refeeding but without subculture. In contrast, stable cultures were maintained in the bioreactor for more than 120 days, suggesting that extended-term tissue maintenance is feasible with little or no special technique. Transmission electron microscopy ultramorphology of tissue derived from hFOB 1.19 recovered from the bioreactor after only 15 days of culture showed evidence of osteocytic-like processes and gap junctions between cells like those observed in vivo, in addition to elaboration of the usual osteoblastic markers such as alkaline phosphatase activity and mineralization (alizarin red). Thus, the bioreactor design based on the principle of simultaneous growth and dialysis was shown to create an extraordinarily stable peri-cellular environment that better simulates the in vivo condition than conventional tissue culture. The bioreactor shows promise as a tool for the in vitro study of osteogenesis and osteopathology.