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BACKGROUND Quality improvement (QI) efforts have become widespread in healthcare, however there is significant variability in their success. Differences in context are thought to be responsible for some of the variability seen. OBJECTIVE: To develop a conceptual model that can be used by organisations and QI researchers to understand and optimise contextual factors affecting the success of a QI project. METHODS: 10 QI experts were provided with the results of a systematic literature review and then participated in two rounds of opinion gathering to identify and define important contextual factors. The experts subsequently met in person to identify relationships among factors and to begin to build the model. RESULTS: The Model for Understanding Success in Quality (MUSIQ) is organised based on the level of the healthcare system and identifies 25 contextual factors likely to influence QI success. Contextual factors within microsystems and those related to the QI team are hypothesised to directly shape QI success, whereas factors within the organisation and external environment are believed to influence success indirectly. CONCLUSIONS: The MUSIQ framework has the potential to guide the application of QI methods in healthcare and focus research. The specificity of MUSIQ and the explicit delineation of relationships among factors allows a deeper understanding of the mechanism of action by which context influences QI success. MUSIQ also provides a foundation to support further studies to test and refine the theory and advance the field of QI science. [ABSTRACT FROM AUTHOR]

Aims: To co-identify adaptations with key stakeholders needed to optimise elements of a video-based intervention (i.e., PREEMIE PROGRESS [PP]), which trains parents in evidence-based family management skills to care for their very preterm infant in the neonatal intensive care unit (NICU)., Design: Descriptive qualitative study oriented with a pragmatic philosophy, informed by the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework and the framework for reporting adaptations and modifications-expanded (FRAME)., Methods: Semistructured interviews to identify potential adaptations with key stakeholders: family management researchers (n = 5), clinicians (n = 9), technology experts (n = 5) and parents of preterm infants (n = 17). Weekly design team meetings to select and implement high-priority adaptations necessary for the next research phase. Monthly NICU parent partnership meetings to review adaptations and make recommendations for potential adaptations with conflicting data., Results: Stakeholders (N = 36) suggested 98 potential adaptations: 32 (33.0%) were completed, 8 (8.2%) were abandoned, 5 (5.2%) have work that is ongoing and 52 (53.6%) were tabled for future research phases. Content adaptations (70, 71.4%) were the most frequently suggested adaptation type. Potential adaptations mostly addressed RE-AIM dimensions of effectiveness (43, 43.9%), and implementation (46, 46.9%) and were directed at the parent (i.e., intervention recipient) level (79, 81.4%)., Conclusion: Use of the RE-AIM framework ensured we systematically identified needed adaptations with key stakeholders across a range of dimensions that would improve PP for parents now and in future phases of this research., Implications for the Profession: Co-identifying potential adaptations with key stakeholders, paired with FRAME documentation, can help nurses prioritise adaptations most appropriate for each phase of implementation., Impact: Our paper highlights for nurse clinicians and researchers how FRAME documentation of potential adaptations can support stakeholder engagement and a systematic approach to incorporating adaptations throughout all phases of the research process, thereby shortening the evidence to practice gap., Reporting Method: COREQ guidelines for qualitative reporting., Patient/public Contribution: The research team was supported by members of the NICU's Parent Partnership Council (PPC), whose mission is to promote family-centred care improvement projects and research within the NICU. This committee is comprised of nursing, physician, allied health leadership and parents of infants previously hospitalised in the NICU. The NICU PPC met monthly to review conflicting data on potential adaptations and provide recommendations on adaptation decisions., (© 2024 The Author(s). Journal of Advanced Nursing published by John Wiley & Sons Ltd.)

Objective: Rates of mother's own milk (MOM) provision in the neonatal intensive care unit (NICU) vary widely, despite acceptance as the gold standard for nutrition in preterm infants. Direct breastfeeding (DBF) supports long-term provision of MOM, but factors that support DBF in preterm infants are unknown. The purpose of this study was to identify factors that predict DBF at oral feeding initiation and at NICU discharge. Methods: This was a retrospective cohort study of preterm infants born at ≤ 32 weeks who were receiving MOM at 32 weeks corrected gestational age (cohort 1) and at discharge to home (cohort 2). The primary outcomes were rates of DBF at oral feeding initiation (cohort 1) and at hospital discharge (cohort 2). We examined bivariate associations between infant characteristics, maternal sociodemographic factors, and hospital practices (e.g., lactation visit timing and frequency) with DBF outcomes and then built logistic regression models to determine the adjusted odds ratio and 95% confidence interval ([adjusted odds ratio [aOR] [95%CI]) for independent predictors of the DBF outcomes. Results: Sixty-four percent of eligible infants initiated DBF, and 51% were DBF at discharge. Sociodemographic, NICU, and lactation support factors were associated with both outcomes. Post hoc analysis showed that similar factors also influenced lactation support provision. Conclusions: Lactation support, NICU and sociodemographic variables influence DBF initiation and DBF at discharge. Interventions that optimize efficient use of available lactation support, address bias, and provide ample opportunity for DBF practice could improve rates.

Objective: Little is known about naloxone care practices for peripartum persons from the patient or provider perspectives. The objective of this study was to survey peripartum persons and providers about naloxone-related practices., Methods: Individuals who had an OUD diagnosis during a pregnancy and Ohio healthcare professionals who provide care for peripartum patients with OUD and/or infants with prenatal exposure to opioids were eligible for this study. Patient experiences were assessed through a survey codeveloped with members with lived experience of opioid use disorder. Provider perspectives were examined through a survey codeveloped by the Ohio Perinatal Quality Collaborative. Descriptive statistics and logistic regression were used to examine the proportion of participants who received or provided naloxone care practices and the effect on having a naloxone kit during the perinatal period., Results: Of the 100 peripartum participants with opioid use disorder, 24% reported receiving naloxone from their prenatal care provider and 48% reported ever having a naloxone kit during the perinatal period. Of the 63 maternal care provider participants, 32 (49%) reported discussing or prescribing naloxone to pregnant patients. Of the 62 pediatric provider participants, 10 (16%) reported that they provide naloxone information to parenting individuals of their patients., Conclusion: Study results demonstrate critical gaps in naloxone care practices for peripartum persons, emphasizing the need for targeted interventions at the patient, clinician, practice, and system levels., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 American Society of Addiction Medicine.)

Quality improvement (QI) has become an integral part of healthcare. Despite efforts to improve the reporting of QI through frameworks such as the SQUIRE 2.0 guidelines, there is no standard or well-accepted guide to evaluate published QI for rigor, validity, generalizability, and applicability. User's Guides for evaluation of published clinical research have been employed routinely for over 25 years; however, similar tools for critical appraisal of QI are limited and uncommonly used. In this article we propose an approach to guide the critical review of QI reports focused on evaluating the methodology, improvement results, and applicability and feasibility for implementation in other settings. The resulting Quality Improvement Critical Knowledge (QUICK) Tool can be used by those reviewing manuscripts submitted for publication, as well as healthcare providers seeking to understand how to apply published QI to their local context., (Copyright © 2024. Published by Elsevier Inc.)

Background: Across the globe, family-integrated care (FICare) has become an evidence-based standard in which parents deliver the majority of infant care in the neonatal intensive care unit (NICU). Because of extensive barriers to parent presence, adaptations to FICare may be required for successful implementation. Family management theory may provide structure to the Parent Education of FICare and help nurses guide parents' skill development as equal care members., Purpose: To identify family management skills employed by NICU parents using the Self- and Family Management Framework (SFMF)., Methods: We conducted secondary analyses of qualitative interview data from NICU parents (n = 17) who shared their experiences of using family management skills to care for their infant. We categorized skills according to 3 main self- and family management processes: Focusing on Infant Illness Needs; Activating Resources; and Living With Infant Illness., Results: Parents reported several family management skills currently identified in the SFMF, as well as new skills such as conflict management, power brokerage, and addressing resources related to social determinants of health. Parent activation of resources was critical to sustaining parent focus on the infant's illness needs., Implications for Practice and Research: By teaching skills that parents reported as helping them manage infant care, neonatal nurses may better facilitate parent integration into the care team. Future researchers can incorporate the skills identified in this study into the design of family management interventions that facilitate FICare implementation in the United States., Competing Interests: Completing Interests Statement: The authors declare no conflicts of interest., (Copyright © 2023 by The National Association of Neonatal Nurses.)

Context and implementation approaches can impede the spread of patient safety interventions. The objective of this article is to characterize factors associated with improved outcomes among 9 hospitals implementing a medication safety intervention. Nephrotoxic Injury Negated by Just-in-Time Action (NINJA) is a pharmacist-driven intervention that led to a sustained reduction in nephrotoxic medication-associated acute kidney injury (NTMx-AKI) at 1 hospital. Using qualitative comparative analysis, the team prospectively assessed the association between context and implementation factors and NTMx-AKI reduction during NINJA spread to 9 hospitals. Five hospitals reduced NTMx-AKI. These 5 had either (1) a pharmacist champion and >2 pharmacists working on NINJA (Scon 1.0, Scov 0.8) or (2) a nephrologist-implementing NINJA with minimal competing organizational priorities (Scon 1.0, Scov 0.2). Interviews identified ways NINJA team leaders obtained pharmacist support or successfully implemented without that support. In conclusion, these findings have implications for future spread of NINJA and suggest an approach to study spread of safety interventions more broadly., (Copyright © 2023 the American College of Medical Quality.)

Objective: Describe the frequency of best practice behaviors during NICU provider and nursing shift-to-shift handoffs and identify strengths and opportunities for improvement., Study Design: Observational study of handoff characteristics among 40 centers participating in a learning collaborative over a 10-month period. Data were gathered using a handoff audit tool that outlined best practices. Comparisons of behaviors between nurse-to-nurse and provider-to-provider handoffs were made where appropriate., Results: Overall, 946 audits of shift-to-shift handoffs were analyzed. While many behaviors were demonstrated reliably, differences between nurse-to-nurse vs provider-to-provider handoffs were noted. Families were present for 5.9% of handoffs and, among those who were present, 48.2% participated by contributing information, asking questions, and sharing goals., Conclusions: Observation and measurement of handoff behaviors can be used to identify opportunities to improve handoff communication, family participation, and human factors that support handoff. Auditing handoffs is feasible and necessary to improve these critical transitions in infants' care., (© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Effective quality improvement (QI) depends on rigorous analysis of time-series data through methods such as statistical process control (SPC). As use of SPC has become more prevalent in health care, QI practitioners must also be aware of situations that warrant special attention and potential modifications to common SPC charts, which include skewed continuous data, autocorrelation, small persistent changes in performance, confounders, and workload or productivity measures. This article reviews these situations and provides examples of SPC approaches for each., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as type 1, there also are new and evolving uses of N-of-1 trials that we designate as type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of type 1, a type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare disease, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multistakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials., (© 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Introduction: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant's baseline, usual diet (UD)., Methods: Across 19 sites, we recruited patients aged 7-18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets., Results: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was <1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was -0.3 (95% credible interval -1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not., Discussion: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness., (Copyright © 2022 by The American College of Gastroenterology.)

As NICU staff work to increase the frequency, duration, and comfort of skin-to-skin care (SSC) sessions, barriers to implementation are frequently encountered. Safety concerns are often raised when parents fall asleep during SSC intentionally or unintentionally. We present a risk management framework that we use in clinical practice to address risk related to parent sleep during SSC. Our approach is based on the steps of the Risk Management Life Cycle, which include the following: establish context, identify risk, analyze risk, respond to risk, and monitor and adapt response to risk. Clinicians may use this framework in clinical practice to manage risks related to prolonged SSC, specifically when parents relax and fall asleep during SSC., Competing Interests: Conflict of Interest Yamile C. Jackson, PhD, PE, PMP, is an ergonomics, safety, and risk engineer and the chief executive officer, Nurtured by Design, Sugar Land, TX. Nurtured by Design is a company that sells a range of developmental care products, including devices to facilitate skin-to-skin care. Dr. Jackson holds a patent for such a device (the Zaky Zak) and receives royalties for her company’s products. Nurtured by Design did not provide any funds or compensation for this work. All other authors report no conflicts of interest or relevant financial relationships., (Copyright © 2022 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.)

Objective: Context is a critical determinant of the effectiveness of quality improvement programs. We assessed the role of contextual factors in influencing the efforts of 5 diverse quality improvement projects as part of the Pediatric Quality Measure Program (PQMP) directed by the Agency for Health Care Research and Quality., Methods: We conducted a mixed methods study of 5 PQMP grantees involving semistructured interviews followed by structured worksheets to identify influential contextual factors. Semistructured interviews and worksheets were completed between August and October 2020. Participants were comprised of PQMP grantee teams (2-4 team members per team for a total of 15 participants). Coding and analysis was based on the Tailored Implementation for Chronic Diseases (TICD) framework., Results: Despite heterogeneity in the process and outcome targets of the PQMP initiatives, professional interactions, incentives and resources, and capacity for organizational change were the domains most commonly identified as influential across the grantees. While social, political, and legal factors was not commonly referenced as an important domain, payer or funder policies (a factor within this domain) was highlighted as one of the most influential factors. Overall, the incentives and resources domain was identified as the most influential., Conclusions: We found that using a determinant framework, such as the TICD, is valuable in facilitating comparisons across heterogeneous projects, allowing us to identify key contextual factors influencing the implementation of pediatric quality measures across a diverse range of clinical topics and settings. Future quality improvement work should account for this and include resources to support infrastructure development in addition to program implementation., (Copyright © 2021 Academic Pediatric Association. All rights reserved.)

Changing health care delivery systems and processes of care to improve health care quality is complex. What is done (intervention) is equally important as how it is done (implementation) and where it is done (context). Furthermore, it has been consistently observed that among groups participating in multisite quality improvement (QI) efforts and implementation studies, significant heterogeneity in the improvements is seen. Our objective is to provide a step-by-step guide to assist both researchers and groups practicing QI on the frontlines in addressing context in planning, implementing, and disseminating their QI and implementation interventions. We discuss in depth a sample of the >60 available dissemination and implementation frameworks that consider context. We then provide an approach to addressing context in QI and implementation initiatives and discuss an application of this approach, using a published study as an example. Finally, we discuss next steps for the field of context and implementation science. Data from networks of health systems working together on QI are needed on both network-wide rates of process and outcome measures. Also needed are segmented/stratified data that inform our understanding of the influence of context on successful implementation in subgroups. Finally, multisite prospective studies are needed to develop an in-depth understanding of how specific context and implementation factors affect the successful spread of proven interventions., Competing Interests: CONFLICT OF INTEREST DISCLOSURE: The authors have no conflicts of interest to disclose., (Copyright © 2022 by the American Academy of Pediatrics.)

Aims: To examine the critical role that an academic clinical partnership played in the development and refinement of a family management intervention in the Neonatal Intensive Care Unit (NICU)., Background: Clinical-academic partnerships enable earlier infusion of implementation science principles into development of evidence-based interventions, yet partners often report difficulty leveraging resources, personnel and expertise to create beneficial outcomes for all., Design: Longitudinal qualitative descriptive design., Methods: To develop and refine the intervention, designated time was taken during meetings of the NICU's Parent Partnership Council (PPC), a committee comprised of nursing, physician and allied health leadership and former NICU parents. Partnership was also achieved by having bedside clinical nurses, in addition to medical and nursing students, participate as research team members. Qualitative data were collected via email, research team and Council meetings, and informal individual chats with key stakeholders (N = 25) and NICU mothers (N = 22). Qualitative data were analysed deductively using thematic analysis based on MacPhee's partnership logic model and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model. The consolidated criteria for reporting qualitative research checklist guided our work., Results: During Council meetings, the clinical-academic nurse, Director of Family-Integrated Care and Council members identified the need for a family management intervention, and worked together to develop and refine PREEMIE PROGRESS. Mothers found the intervention had numerous strengths and perceived a benefit knowing they helped future parents., Conclusions: This work was only possible by leveraging both the university's technology/research resources and the clinical expertise of the NICU staff and PPC. Co-authored presentations, publications and grant funding continued this NICU's legacy in family-centred care and helped shape the clinical-academic nurse's career., Relevance to Clinical Practice: Clinical-academic partnerships can promote excellence in nursing practice, research and education through swifter knowledge translation and earlier infusion of implementation science principles into the development of evidence-based nursing interventions., (© 2021 John Wiley & Sons Ltd.)

Objective: To examine the incidence of postoperative neonatal acute kidney injury (AKI) following general surgical procedures and to test the hypothesis that postoperative urine neutrophil gelatinase-associated lipocalin (uNGAL) concentrations predict AKI. The secondary objective was to evaluate for an association between AKI and hospital mortality., Study Design: Prospective observational study of infants undergoing abdominal and thoracic surgical procedures in the neonatal intensive care unit from October 2018 to March 2020. The primary outcome was incidence of neonatal AKI (defined by the neonatal modified Kidney Diseases Improving Global Outcomes criteria) following each procedure to postoperative day 5. Severe AKI was defined as stage 2 or 3 AKI. Urine samples were obtained pre- and postoperatively at 6 time points to evaluate for levels of uNGAL. Secondary outcomes were in-hospital mortality and length of stay., Results: Subjects (n = 141) underwent a total of 192 general surgical procedures during the study period. Neonatal AKI and severe AKI occurred following 36 (18%) and 15 (8%) procedures (n = 33 subjects). Percent change of uNGAL from 24 hours preoperatively to 24 hours postoperatively was greater in subjects with neonatal AKI (190.2% [IQR 0.0, 1666.7%] vs 0.7% [IQR -31.2%,140.2%], P = .0374). The strongest association of uNGAL and AKI occurred at 24 hours postoperatively (area under the receiver operator curves of 0.81, 95% CI 0.72, 0.89). Increased mortality risk was observed in subjects with any postoperative AKI (aOR 11.1 95% CI 2.0, 62.8, P = .0063) and severe AKI (aOR 13.8; 95% CI 3.0, 63.1, P = .0007)., Conclusion: Elevation in uNGAL 24 hours postoperative was associated with AKI. Neonates with postoperative AKI had increased mortality., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Individuals with opioid use disorder often report feelings of shame and describe feeling judged negatively. These feelings are especially true for pregnant women with opioid use disorder. The Ohio Perinatal Quality Collaborative conducted a multimodal quality improvement initiative for infants born with Neonatal Abstinence Syndrome (NAS). An important component of the project was focused on improving staff attitudes toward mothers of infants with NAS., Methods: The Ohio Perinatal Quality Collaborative implemented an education program for healthcare providers at 39 participating hospital units regarding opioid use as a chronic disease and principles of nonjudgmental, trauma-informed care. Healthcare providers partnered with the mother of infants with NAS in the care of the infant and connected with local community resources. This work was a subcomponent of an overall multimodal quality improvement project. Healthcare provider attitudes were measured with the "Attitude Measurement: Brief Scales" questionnaire anonymously, at 3 different time points throughout the project. Attitude change was measured by pretraining and posttraining scores. ANOVA methods were used to compare individual items and a summary score across the 3 surveys., Results: Summary scores improved significantly from 18.99 at baseline (January-March 2014) to 19.94 ( P < 0.0001) in February 2015 and were maintained at 20.05 in July 2016., Conclusions: A nonjudgmental attitude toward mothers of infants with NAS is an important component of compassionate care. Improving healthcare provider attitudes can benefit a mother of an infant with NAS and help preserve the mother-infant dyad., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Protein content is often inadequate in donor breast milk (DBM), resulting in poor growth. The use of protein-enriched target-pooled DBM (DBM+) has not been examined. We compared three cohorts of very low birth weight (VLBW) infants, born ≤ 1500 g: DBM cohort receiving > 1-week target-pooled DBM (20 kcal/oz), MBM cohort receiving ≤ 1-week DBM, and DBM+ cohort receiving > 1-week DBM+. Infants followed a standardized feeding regimen with additional fortification per clinical discretion. Growth velocities and z-scores were calculated for the first 4 weeks ( n = 69 for DBM, 71 for MBM, 70 for DBM+) and at 36 weeks post-menstrual age ( n = 58, 64, 59, respectively). In total, 60.8% MBM infants received fortification >24 kcal/oz in the first 30 days vs. 78.3% DBM and 77.1% DBM+. Adjusting for SGA, length velocity was greater with DBM+ than DBM in week 1. Average weight velocity and z-score change were improved with MBM compared to DBM and DBM+, but length z-score decreased similarly across all groups. Incidences of NEC and feeding intolerance were unchanged between eras. Thus, baseline protein enrichment appears safe in stable VLBW infants. Weight gain is greatest with MBM. Linear growth comparable to MBM is achievable with DBM+, though the overall length trajectory remains suboptimal.

Background: Mobile health (mHealth) technology has the potential to support the Chronic Care Model's vision of closed feedback loops and patient-clinician partnerships., Objective: This study aims to evaluate the feasibility, acceptability, and short-term impact of an electronic health record-linked mHealth platform (Orchestra) supporting patient and clinician collaboration through real-time, bidirectional data sharing., Methods: We conducted a 6-month prospective, pre-post, proof-of-concept study of Orchestra among patients and parents in the Cincinnati Children's Hospital inflammatory bowel disease (IBD) and cystic fibrosis (CF) clinics. Participants and clinicians used Orchestra during and between visits to complete and view patient-reported outcome (PRO) measures and previsit plans. Surveys completed at baseline and at 3- and 6-month follow-up visits plus data from the platform were used to assess outcomes including PRO completion rates, weekly platform use, disease self-efficacy, and impact on care. Analyses included descriptive statistics; pre-post comparisons; Pearson correlations; and, if applicable, effect sizes., Results: We enrolled 92 participants (CF: n=52 and IBD: n=40), and 73% (67/92) completed the study. Average PRO completion was 61%, and average weekly platform use was 80%. Participants reported improvement in self-efficacy from baseline to 6 months (7.90 to 8.44; P=.006). At 6 months, most participants reported that the platform was useful (36/40, 90%) and had a positive impact on their care, including improved visit quality (33/40, 83%), visit collaboration (35/40, 88%), and visit preparation (31/40, 78%). PRO completion was positively associated with multiple indicators of care impact at 3 and 6 months., Conclusions: Use of an mHealth tool to support closed feedback loops through real-time data sharing and patient-clinician collaboration is feasible and shows indications of acceptability and promise as a strategy for improving pediatric chronic illness management., (©Lisa Opipari-Arrigan, Dana M H Dykes, Shehzad A Saeed, Sunny Thakkar, Lisa Burns, Barbara A Chini, Gary L McPhail, Ian Eslick, Peter A Margolis, Heather C Kaplan. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 26.11.2020.)

Background: Despite the standardization of care, formula feeding varied across sites of the Ohio Perinatal Quality Collaborative (OPQC). We used orchestrated testing (OT) to learn from this variation and improve nonpharmacologic care of infants with neonatal abstinence syndrome (NAS) requiring pharmacologic treatment in Ohio., Methods: To test the impact of formula on length of stay (LOS), treatment failure, and weight loss among infants hospitalized with NAS, we compared caloric content (high versus standard) and lactose content (low versus standard) using a 2 2 factorial design. During October 2015 to June 2016, OPQC sites joined 1 of 4 OT groups. We used response plots to examine the effect of each factor and control charts to track formula use and LOS. We used the OT results to revise the nonpharmacologic bundle and implemented it during 2017., Results: Forty-seven sites caring for 546 NAS infants self-selected into the 4 OT groups. Response plots revealed the benefit of high-calorie formula (HCF) on weight loss, treatment failure, and LOS. The nonpharmacologic treatment bundle was updated to recommend HCF when breastfeeding was not possible. During implementation, HCF use increased, and LOS decreased from 17.1 to 16.4 days across the OPQC., Conclusions: OT revealed that HCF was associated with shorter LOS in OPQC sites. Implementation of a revised nonpharmacologic care bundle was followed by additional LOS improvement in Ohio. Despite some challenges in the implementation of OT, our findings support its usefulness for learning in improvement networks., Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Wexelblatt is on the speaker bureau for Abbott Nutrition with a specific focus on neonatal abstinence syndrome; the other authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2020 by the American Academy of Pediatrics.)

Objective: Assess practices supporting care transitions for infants and families in the neonatal intensive care unit (NICU) using a model of four key drivers: communication, teamwork, family integration, and standardization., Study Design: Single-day audit among NICUs in the Vermont Oxford Network Critical Transitions collaborative addressing policies and practices supporting the four key drivers during admission, discharge, shift-to-shift handoffs, within hospital transfers, and select changes in clinical status., Results: Among 95 NICUs, the median hospital rate of audited policies in place addressing the four key drivers were 47% (inter-quartile range (IQR) 35-65%) for communication, 67% (IQR 33-83%) for teamwork, 50% (IQR 33-61%) for family integration, and 70% (IQR 56-85%) for standardization. Of the 2462 infants included, 1066 (43%) experienced ≥1 specified transition during the week prior to the audit., Conclusions: We identified opportunities for improving NICU transitions in areas of communication, teamwork, family integration, and standardization.

Objective: To understand the opinions of clinicians about the risks, benefits, barriers, and facilitators to the practice of parent sleep during skin-to-skin care in hospital settings., Design: Cross-sectional survey., Setting: Online survey., Participants: Clinicians who self-identified as infant care providers, that is, neonatal clinicians (N = 158)., Methods: We sent an online survey invitation to neonatal clinicians through neonatal websites, conferences, and social media sites in the United States and used snowball recruitment. We used a risk management framework to analyze qualitative data. We used descriptive statistics and the chi-square and Fisher's exact tests to determine if opinions differed based on clinician and organizational characteristics., Results: Respondents' support of parent sleep during skin-to-skin care (yes/no) did not differ on the basis of whether the clinician had taken a formal course on skin-to-skin care, facilitated skin-to-skin care more than 100 times, or frequently promoted skin-to-skin care in current practice. Respondents who supported parent sleep (n = 93, 59% of respondents) reported greater implementation of risk control strategies than nonsupporters (n = 53 [57%] vs. n = 3 [5%]; p < .001), such as frequent monitoring of vital signs (n = 33 [35%] vs. n = 2 [3%]; p < .001), use of devices to support skin-to-skin care (n = 49 [53%] vs. n = 19 [29%]; p = .003), and proper positioning (n = 20 [22%] vs. n = 0 [0%]; p < .001). Nonsupporters more frequently reported that parent sleep during skin-to-skin care violates safe sleep recommendations, is habit forming for home, poses a fall risk, and jeopardizes the infant's airway., Conclusion: Most respondents supported parent sleep during skin-to-skin care, but concerns regarding safety for the infant remained a barrier. The use of a risk management framework may help facilitate a systematic approach to improve the implementation of safe skin-to-skin practices., (Copyright © 2020 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.)

Measurement is a core foundation of quality improvement (QI), and analysis of data for QI requires distinct approaches and tools as compared with other areas of healthcare. QI efforts can use structural, process, outcome, and balancing measures, and each measure should have a clear operational definition. Data for improvement should be analyzed dynamically over time, with a focus on understanding the variation present in the data. Distinguishing between common cause and special cause variation is necessary to evaluate and guide improvement efforts. Statistical process control tools such as run charts and control charts can be powerful tools to analyze data over time and help understand variation. This article continues a series of QI educational papers in the Journal of Perinatology, and offers a review of the use of data and measures to drive improvement.

Inflammatory bowel disease (IBD) affects 3 million children and adults in the US. Treatment involves medications with considerable risk profiles. Dietary modification, such as the specific carbohydrate diet (SCD), may be helpful in treating IBD, but there is insufficient evidence of its effectiveness. N-of-1 trials are ideal for addressing this important research question. The Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (PRODUCE) study employs a series of 50 individual N-of-1 trials that compare the SCD to a modified SCD. Treatment periods are assigned in blocks of two, with each patient completing two balanced treatment blocks. Patients are randomized to start with the SCD or modified SCD and alternate between conditions for four eight-week periods. A mobile app guides collecting and viewing data, transitioning diets, and reviewing personal results. Primary outcomes include patient reported outcomes (PROs) of stool frequency, stool consistency, pain interference, and gastrointestinal (GI) symptom severity. We examine changes in inflammation via fecal calprotectin. Participants will receive a personalized answer regarding comparative effectiveness between the SCD and a less restrictive diet option (modified SCD), as well as compared to their baseline diet. We will aggregate the results of completed N-of-1 trials across patients to estimate population level comparative effectiveness of these treatments and the effectiveness of each diet., Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

The US National Academy of Sciences has called for the development of a Learning Healthcare System in which patients and clinicians work together to choose care, based on best evidence, and to drive discovery as a natural outgrowth of every clinical encounter to ensure innovation, quality and value at the point of care. However, the vision of a Learning Healthcare System has remained largely aspirational. Over the last 13 years, researchers, clinicians and families, with support from our paediatric medical centre, have designed, developed and implemented a network organisational model to achieve the Learning Healthcare System vision. The network framework aligns participants around a common goal of improving health outcomes, transparency of outcome measures and a flexible and adaptive collaborative learning system. Team collaboration is promoted by using standardised processes, protocols and policies, including communication policies, data sharing, privacy protection and regulatory compliance. Learning methods include collaborative quality improvement using a modified Breakthrough Series approach and statistical process control methods. Participants observe their own results and learn from the experience of others. A common repository (a 'commons') is used to share resources that are created by participants. Standardised technology approaches reduce the burden of data entry, facilitate care and result in data useful for research and learning. We describe how this organisational framework has been replicated in four conditions, resulting in substantial improvements in outcomes, at scale across a variety of conditions., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: The importance of contextual factors in influencing quality improvement and implementation (QI&I) initiatives is broadly acknowledged. Existing treatments of context have primarily viewed it as static and distinct from interventions themselves. The objective of this study was to advance understanding of the complex and dynamic interaction between context, intervention, and implementation strategies. Using the Model for Understanding Success in Quality (MUSIQ), we aimed to better understand the roles of, and inter-relationships between, contextual factors within QI&I initiatives., Methods: Secondary analysis was performed on qualitative data collected as part of two studies: (1) an evaluation of a state-wide obstetrical quality improvement (QI) initiative, and (2) a study of the use of Plan-Do-Study-Act cycle method in QI projects. Electronic coding databases from each study were reviewed jointly. Data analysis was initiated deductively using MUSIQ as a template. Codes were added in an inductive manner., Results: All original factors in MUSIQ were observed to be important in the QI initiatives studied and new factors were identified. Three distinct types of context were identified; the setting(s) of care in which QI&I takes place (Type 1); the context of the team conducting a specific project (Type 2); and the wider context supporting general QI&I (Type 3). The picture of context emerging from this study is a dynamic one with multiple, closely-linked factors operating at different levels in a system that is constantly changing in response to QI&I initiatives. To capture this complexity, a revised model (MUSIQ v2.0) was created positioning use of structured QI&I approaches as the focal point and demonstrating how context influenced effective use of these approaches, and in turn, how these approaches supported teams in navigating context by adapting interventions to fit local settings., Conclusions: MUSIQ is a useful tool to explore the roles of, and inter-relationships between, contextual factors within QI&I initiatives. The revised model may help address some existing controversies about how context influences QI&I success and help ensure that future research efforts consider context not as static background, but as a complex system that is constantly changing, tightly-linked, and governed by feedback loops.

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.

Objective: Necrotizing enterocolitis (NEC) is a devastating intestinal disease in premature infants. Local rates of NEC were unacceptably high. We hypothesized that utilizing quality improvement methodology to standardize care and apply evidence-based practices would reduce our rate of NEC., Study Design: A multidisciplinary team used the model for improvement to prioritize interventions. Three neonatal intensive care units (NICUs) developed a standardized feeding protocol for very low birth weight (VLBW) infants, and employed strategies to increase the use of human milk, maximize intestinal perfusion, and promote a healthy microbiome., Results: The primary outcome measure, NEC in VLBW infants, decreased from 0.17 cases/100 VLBW patient days to 0.029, an 83% reduction, while the compliance with a standardized feeding protocol improved., Conclusion: Through reliable implementation of evidence-based practices, this project reduced the regional rate of NEC by 83%. A key outcome and primary driver of success was standardization across multiple NICUs, resulting in consistent application of best practices and reduction in variation.

Objective: To evaluate the success of a quality improvement initiative to reduce early elective deliveries at less than 39 weeks of gestation and improve birth registry data accuracy rapidly and at scale in Ohio., Methods: Between February 2013 and March 2014, participating hospitals were involved in a quality improvement initiative to reduce early elective deliveries at less than 39 weeks of gestation and improve birth registry data. This initiative was designed as a learning collaborative model (group webinars and a single face-to-face meeting) and included individual quality improvement coaching. It was implemented using a stepped wedge design with hospitals divided into three balanced groups (waves) participating in the initiative sequentially. Birth registry data were used to assess hospital rates of nonmedically indicated inductions at less than 39 weeks of gestation. Comparisons were made between groups participating and those not participating in the initiative at two time points. To measure birth registry accuracy, hospitals conducted monthly audits comparing birth registry data with the medical record. Associations were assessed using generalized linear repeated measures models accounting for time effects., Results: Seventy of 72 (97%) eligible hospitals participated. Based on birth registry data, nonmedically indicated inductions at less than 39 weeks of gestation declined in all groups with implementation (wave 1: 6.2-3.2%, P<.001; wave 2: 4.2-2.5%, P=.04; wave 3: 6.8-3.7%, P=.002). When waves 1 and 2 were participating in the initiative, they saw significant decreases in rates of early elective deliveries as compared with wave 3 (control; P=.018). All waves had significant improvement in birth registry accuracy (wave 1: 80-90%, P=.017; wave 2: 80-100%, P=.002; wave 3: 75-100%, P<.001)., Conclusions: A quality improvement initiative enabled statewide spread of change strategies to decrease early elective deliveries and improve birth registry accuracy over 14 months and could be used for rapid dissemination of other evidence-based obstetric care practices across states or hospital systems.

Objectives: Neonatal abstinence syndrome (NAS) after an infant's in-utero exposure to opioids has increased dramatically in incidence. No treatment standards exist, leading to substantial variations in practice, degree of opioid exposure, and hospital length of stay., Methods: The Ohio Perinatal Quality Collaborative conducted an extensive multi-modal quality improvement initiative with the goal to (1) standardize identification, nonpharmacologic and pharmacologic treatment in level-2 and 3 NICUs in Ohio, (2) reduce the use of and length of treatment with opioids, and (3) reduce hospital length of stay in pharmacologically treated newborns with NAS., Results: Fifty-two of 54 (96%) Ohio NICUs participated in the collaborative. Compliance with the nonpharmacologic bundle improved from 37% to 59%, and the pharmacologic bundle improved from 59% to 68%. Forty-eight percent of the 3266 opioid-exposed infants received pharmacologic treatment of symptoms of NAS, and this rate did not change significantly across the time period. Regardless of the opioid used to pharmacologically treat infants with NAS, the length of treatment decreased from 13.4 to 12.0 days, and length of stay decreased from 18.3 to 17 days., Conclusions: Standardized approaches to the identification and nonpharmacologic and pharmacologic care were associated with a reduced length of opioid exposure and hospital stay in a large statewide collaborative. Other states and institutions treating opioid-exposed infants may benefit from the adoption of these practices., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2018 by the American Academy of Pediatrics.)

Quality improvement (QI) is based on measuring performance over time, and variation in data measured over time must be understood to guide change and make optimal improvements. Common cause variation is natural variation owing to factors inherent to any process; special cause variation is unnatural variation owing to external factors. Statistical process control methods, and particularly control charts, are robust tools for understanding data over time and identifying common and special cause variation. This review provides a practical introduction to the use of control charts in health care QI, with a focus on neonatology., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Quality improvement in health care is an ongoing challenge. Consideration of the context of the health care system is of paramount importance. Staff resilience and teamwork climate are key aspects of context that drive quality. Teamwork climate is dynamic, with well-established tools available to improve teamwork for specific tasks or global applications. Similarly, burnout and resilience can be modified with interventions such as cultivating gratitude, positivity, and awe. A growing body of literature has shown that teamwork and burnout relate to quality of care, with improved teamwork and decreased burnout expected to produce improved patient quality and safety., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background  Birth registry data are universally collected, generating large administrative datasets. However, these data are typically not used for quality improvement (QI) initiatives in perinatal medicine because the quality and timeliness of the information is uncertain. Objective  We sought to identify and address causes of inaccuracy in recording birth registry information so that birth registry data could support statewide obstetrical quality initiatives in Ohio. Study Design  The Ohio Perinatal Quality Collaborative and the Ohio Department of Health Vital Statistics used QI techniques in 15 medium-sized maternity hospitals to identify and remove systemic sources of inaccuracy in birth registry data. The primary outcome was the rate of scheduled deliveries without medical indication between 37 0/7 and 38 6/7 weeks at participating hospitals from birth registry data. Results  Inaccurate birth registry data most commonly resulted from limited communication between clinical and medical record staff. The rate of scheduled births between 37 0/7 and 38 6/7 weeks' gestation without a documented medical indication as recorded in the birth registry declined by 35%. Conclusion  A QI initiative aimed at increasing the accuracy of birth registry information demonstrated the utility of these data for surveillance of perinatal outcomes and has led to ongoing efforts to support birth registrars in submitting accurate data., Competing Interests: Funding: This study was financially supported by CDC: Ohio State-Based Perinatal Initiative: 1U38DP003787-01; SQIM: 2011–2012 MEDTAPP/BEACON Statewide Quality Improvement Manager: G-1213-07-0343; GRC CONTRACTS: 2011–2012 MEDTAPP/BEACON Perinatal Quality: Rose G-1213-07-0343. Conflict of Interest None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Successful quality improvement (QI) requires a supportive context. The goal was to determine whether a structured curriculum could help QI teams improve the context supporting their QI work. An exploratory field study was conducted of 43 teams participating in a neonatal intensive care unit QI collaborative. Using a curriculum based on the Model for Understanding Success in Quality, teams identified gaps in their context and tested interventions to modify context. Surveys and self-reflective journals were analyzed to understand how teams developed changes to modify context. More than half (55%) targeted contextual improvements within the microsystem, focusing on motivation and culture. "Information sharing" interventions to communicate information about the project as a strategy to engage more staff were the most common interventions tested. Further study is needed to determine if efforts to modify context consistently lead to greater outcome improvements.

Background: Pediatric chronic illness care models are traditionally organized around acute episodes of care and may not meet the needs of patients and their families. Interventions that extend the patient-clinician interaction beyond the health care visit, allow for asynchronous and bidirectional feedback loops that span visits and daily life, and facilitate seamless sharing of information are needed to support a care delivery system that is more collaborative, continuous, and data-driven. Orchestra is a mobile health technology platform and intervention designed to transform the management of chronic diseases by optimizing patient-clinician coproduction of care., Objective: The aim of this study is to assess the feasibility, acceptability, and preliminary impact of the Orchestra technology and intervention in the context of pediatric chronic illness care., Methods: This study will be conducted in the cystic fibrosis and inflammatory bowel disease clinics at Cincinnati Children's Hospital Medical Center. We will enroll interested patients and their caregivers to work with clinicians to use the Orchestra technology platform and care model over a 6-month period. In parallel, we will use quality improvement methods to improve processes for integrating Orchestra into clinic workflows and patient/family lifestyles. We will use surveys, interviews, technology use data, and measures of clinical outcomes to assess the feasibility, acceptability, and preliminary impact of Orchestra. Outcome measures will include assessments of: (1) enrollment and dropout rates; (2) duration of engagement/sustained use; (3) symptom and patient-reported outcome tracker completion rates; (4) perceived impact on treatment plan, communication with the clinical team, visit preparation, and overall care; (5) changes in disease self-efficacy and engagement in care; and (6) clinical outcomes and health care utilization., Results: Participant recruitment began in mid-2015, with results expected in 2017., Conclusions: Chronic disease management needs a dramatic transformation to support more collaborative, effective, and patient-centered care. This study is unique in that it is testing not only the impact of technology, but also the necessary processes that facilitate patient and clinician collaboration. This pilot study is designed to examine how technology-enabled coproduction can be implemented in real-life clinical contexts. Once the Orchestra technology and intervention are optimized to ensure feasibility and acceptability, future studies can test the effectiveness of this approach to improve patient outcomes and health care value., (©Heather C Kaplan, Sunny Narendra Thakkar, Lisa Burns, Barbara Chini, Dana MH Dykes, Gary L McPhail, Erin Moore, Shehzad Ahmed Saeed, Ian Eslick, Peter A Margolis, Lisa Opipari-Arrigan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.04.2017.)

The quality of health care is now recognized to vary widely in all medical specialties, including perinatal medicine. A national focus on quality improvement (QI) and patient safety is prompting providers to change and improve the care given to patients. All QI and safety efforts require the use of an improvement model to manage the complex process of improving care. This article reviews the most common frameworks in use today, including the Model for Improvement, Six Sigma, and Lean. Specific tools such as affinity, key driver and fishbone diagrams, process maps and statistical process control, as well as checklists are reviewed, with examples from the perinatal literature to illustrate their use in perinatal QI efforts., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: To promote use of progestogen therapy to reduce premature births in Ohio by 10%., Methods: The Ohio Perinatal Quality Collaborative initiated a quality improvement project in 2014 working with clinics at 20 large maternity hospitals, Ohio Medicaid, Medicaid insurers, and service agencies to use quality improvement methods to identify eligible women and remove treatment barriers. The number of women eligible for prophylaxis, the percent prescribed a progestogen before 20 and 24 weeks of gestation, and barriers encountered were reported monthly. Clinics were asked to adopt protocols to identify candidates and initiate treatment promptly. System-level changes were made to expand Medicaid eligibility, maintain Medicaid coverage during pregnancy, improve communication, and adopt uniform data collection and efficient treatment protocols. Rates of singleton births before 32 and 37 weeks of gestation in Ohio hospitals were primary outcomes. We used statistical process control methods to analyze change and generalized linear mixed models to estimate program effects accounting for known risk factors., Results: Participating sites tracked 2,562 women eligible for treatment between January 1, 2014, and November 30, 2015. Late entry to care, variable interpretation of treatment guidelines, maintenance of Medicaid coverage, and inefficient communication among health care providers and insurers were identified as treatment barriers. Births before 32 weeks of gestation decreased in all hospitals by 6.6% and in participating hospitals by 8.0%. Births before 32 weeks of gestation to women with prior preterm birth decreased by 20.5% in all hospitals, by 20.3% in African American women, and by 17.1% in women on Medicaid. Births before 37 weeks of gestation were minimally affected. Adjusting for risk factors and birth clustering by hospital confirmed a program-associated 13% (95% confidence interval 0.3-24%) reduction in births before 32 weeks of gestation to women with prior preterm birth., Conclusion: The Ohio progestogen project was associated with a sustained reduction in singleton births before 32 weeks of gestation in Ohio.

Since its publication in 2008, SQUIRE (Standards for Quality Improvement Reporting Excellence) has contributed to the completeness and transparency of reporting of quality improvement work, providing guidance to authors and reviewers of reports on healthcare improvement work. In the interim, enormous growth has occurred in understanding factors that influence the success, and failure, of healthcare improvement efforts. Progress has been particularly strong in three areas: the understanding of the theoretical basis for improvement work; the impact of contextual factors on outcomes; and the development of methodologies for studying improvement work. Consequently, there is now a need to revise the original publication guidelines. To reflect the breadth of knowledge and experience in the field, we solicited input from a wide variety of authors, editors and improvement professionals during the guideline revision process. This Explanation and Elaboration document (E&E) is a companion to the revised SQUIRE guidelines, SQUIRE 2.0. The product of collaboration by an international and interprofessional group of authors, this document provides examples from the published literature, and an explanation of how each reflects the intent of a specific item in SQUIRE. The purpose of the guidelines is to assist authors in writing clearly, precisely and completely about systematic efforts to improve the quality, safety and value of healthcare services. Authors can explore the SQUIRE statement, this E&E and related documents in detail at http://www.squire-statement.org., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Introduction: Improving symptoms for patients with chronic illness is difficult due to poor recall and imprecise assessments of therapeutic response to inform treatment decisions. Daily variation in symptoms may obscure subtle improvement or lead to erroneous associations between symptom changes and alteration in medication or dietary regimens. This may lead to mistaken impressions of treatment efficacy (or inefficacy). Mobile health technologies that collect daily patient reported outcome (PRO) data have the potential to improve care by providing more detailed information for clinical decision-making in practice and may facilitate conducting single subject (n-of-1) trials., Methods: Interrupted time series to prototype mobile health enabled data collection for three patients. We recruited pediatric patients with established inflammatory bowel disease who had persistent symptoms. Based on their self-identified most troubling symptoms, patients were sent customized, daily-automated text messages to assess the extent of their symptoms. Standardized, PRO Measurement Information System (PROMIS) surveys were deployed weekly. Individual statistical process control charts were used to assess variation. Patients met with physicians regularly to interpret their data jointly., Results: We report the experience of 3 patients with inflammatory bowel disease, each with different symptoms. Daily symptom monitoring uncovered important patterns, some of which even patients were unaware before reviewing their symptom data. Important associations were found between symptom variation and changes in medications and diet. PROMIS survey results assessed longitudinally accurately reflected changes in patient symptoms., Conclusions: We demonstrated how PROs can be implemented in practice. Monitoring and analyzing daily symptom data, using both customized and standard PROs, has the potential to detect meaningful variation in symptom patterns, which can inform clinical decision-making or can facilitate conducting formal n-of-1 trials to further improve outcomes.

Background: Antenatal corticosteroids (ANCS) reduce complications of preterm birth; however, not all eligible women receive them. Many hospitals and providers do not have the right processes and conditions to enable ANCS administration with high reliability. The objective of this study was to understand conditions that enable delivery of ANCS with high reliability among hospitals participating in an Ohio Perinatal Quality Collaborative (OPQC) ANCS project., Methods: We conducted focus groups and semistructured interviews with members of the OPQC project team (n=27) and other care providers (n=70) using a purposeful sample of 6 sites involved in the OPQC ANCS project. Participants including nurses (n=57), attending obstetricians (n=17), physician trainees (n=21) and certified nurse midwives (n=2) were asked to reflect on their experiences and to identify factors contributing to optimal use of ANCS. Focus groups and interviews were transcribed verbatim and were analysed by a multidisciplinary team using an iterative approach that combined inductive and deductive methods to identify and categorise themes., Results: Six major themes supporting reliable implementation of ANCS at these hospitals emerged including: (1) presence of a high reliability culture, (2) processes that emphasise high reliability, (3) timely and efficient administration process, (4) multiple disciplines are involved, (5) evidence of benefit supports ANCS use and (6) benefit is recognised at all levels of the care team., Conclusions: Our findings identify the key processes and supports needed to ensure delivery of ASCS with high reliability and are reinforced by implementation and reliability science. They are useful for foundation of the successful implementation of other evidence-based practices at high levels of reliability., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: At the time of the research, Dr Weiss was a clinical fellow in neonatal-perinatal medicine at Baylor College of Medicine, Texas Children's Hospital. Dr Profit was on faculty at Baylor College of Medicine, Texas Children's Hospital, Department of Pediatrics, Section of Neonatology. He held a secondary appointment in the Department of Medicine, Section of Health Services Research and conducted his research at the VA Health Services Research and Development Center of Excellence where he collaborated with Dr Kowalkowski.: Improving the quality of neonatal intensive care is an important health policy priority in Mexico. A formal assessment of barriers and priorities for quality improvement has not been undertaken., Aim: To provide guidance to providers and policy makers with regard to addressing opportunities for better care delivery in Mexican neonatal intensive care units., Objective: To conduct a needs assessment regarding improvement of quality of neonatal intensive care delivery in Mexico., Methods: Spanish-language survey administered to a volunteer sample of Mexican neonatal care providers attending a large paediatric conference in Mexico in June 2011. Survey domains included institutional context of quality improvement, barriers, priorities, safety culture, and respondents' characteristics. Results were analysed using descriptive analyses of frequencies, proportions and percentage positive response (PPR) rates., Results: Of 91 respondents, the majority identified neonatology as their primary specialty (n = 48, 65%) and were physicians (n = 55, 73%). Generally, providers expressed a desire to improve quality of care (PPR 69%) but reported notable deterrents. Respondents (n, %) identified family inability to pay (38, 48%), overcrowded work areas (38, 44%), insufficient financial reimbursement (25, 36%), lack of availability of nurses (26, 30%), ancillary staff (25, 29%), and subspecialists (22, 25%) as the principal barriers. Respiratory care (27, 39%)--reduction of mechanical ventilation and initiation of nasal continuous positive airway pressure--and reduction in frequency of late-onset infections (19, 28%) were selected as top clinical priorities. There were substantial opportunities for improving safety (PPR 48%) and teamwork climate (PPR 58%)., Conclusion: These findings may guide efforts to improving quality of care delivery in Mexican neonatal intensive care units.

Objective: Neonatal abstinence syndrome (NAS) is a drug withdrawal syndrome experienced by opioid-exposed infants. There is no standard treatment for NAS and surveys suggest wide variation in pharmacotherapy for NAS. Our objective was to determine whether different pharmacotherapies for NAS are associated with differences in outcomes and to determine whether pharmacotherapy and outcome vary by hospital., Study Design: We used the Pediatric Health Information System Database from 2004 to 2011 to identify a cohort of infants with NAS requiring pharmacotherapy. Mixed effects hierarchical negative binomial models evaluated the association between pharmacotherapy and hospital with length of stay (LOS), length of treatment (LOT) and hospital charges, after adjusting for socioeconomic variables and comorbid clinical conditions., Result: Our cohort included 1424 infants with NAS from 14 children's hospitals. Among hospitals in our sample, six used morphine, six used methadone and two used phenobarbital as primary initial treatment for NAS. In multivariate analysis, when compared with NAS patients initially treated with morphine, infants treated with methadone had shorter LOT (incidence rate ratio (IRR) = 0.55; P < 0.0001) and LOS (IRR = 0.60; P < 0.0001). Phenobarbital as a second-line agent was associated with increased LOT (IRR = 2.09; P<0.0001), LOS (IRR = 1.78; P < 0.0001) and higher hospital charges (IRR = 1.84; P < 0.0001). After controlling for case-mix, hospitals varied in LOT, LOS and hospital charges., Conclusion: We found variation in hospital in treatment for NAS among major US children's hospitals. In analyses controlling for possible confounders, methadone as initial treatment was associated with reduced LOT and hospital stay.

Background: Experience suggests that differences in context produce variability in the effectiveness of quality improvement (QI) interventions. However, little is known about which contextual factors affect success or how they exert influence., Purpose: Using the Model for Understanding Success in Quality (MUSIQ), we perform exploratory quantitative tests of the role of context in QI success., Methodology: We used a cross-sectional design to survey individuals participating in QI projects in three settings: a pediatric hospital, hospitals affiliated with a state QI collaborative, and organizations sponsoring participants in an improvement advisor training program. Individuals participating in QI projects completed a questionnaire assessing contextual factors included in MUSIQ and measures of perceived success. Path analysis was used to test the direct, indirect, and total effects of context variables on QI success as hypothesized in MUSIQ., Findings: In the 74 projects studied, most contextual factors in MUSIQ were found to be significantly related to at least one QI project performance outcome. Contextual factors exhibiting significant effects on two measures of perceived QI success included resource availability, QI team leadership, team QI skills, microsystem motivation, microsystem QI culture, and microsystem QI capability. There was weaker evidence for effects of senior leader project sponsors, organizational QI culture, QI team decision-making, and microsystem QI leadership. These initial tests add to the validity of MUSIQ as a tool for identifying which contextual factors affect improvement success and understanding how they exert influence., Practice Implications: Using MUSIQ, managers and QI practitioners can begin to identify aspects of context that must be addressed before or during the execution of QI projects and plan strategies to modify context for increased success. Additional work by QI researchers to improve the theory, refine measurement approaches, and validate MUSIQ as a predictive tool in a wider range of QI efforts is necessary.

Background: Interest in the use of social network analysis (SNA) in healthcare research has increased, but there has been little methodological research on how to choose the name generators that are often used to collect primary data on the social connection between individuals for SNA., Objective: We sought to determine a minimum set of name generators sufficient to distinguish the social networks of a target population of physicians active in quality improvement (QI)., Methods: We conducted a pilot survey including 8 name generators in a convenience sample of 25 physicians active in QI to characterize their social networks. We used multidimensional scaling to determine what subset of these name generators was needed to distinguish these social networks., Results: We found that some physicians maintain a social network organized around a specific colleague who performed multiple roles while others maintained highly differentiated networks. We found that a set of 5 of the 8 name generators we used was needed to distinguish the networks of these physicians., Conclusions: Beyond methodology for selecting name generators, our findings suggest that QI networks may require 5 or more generators to elicit valid sets of relevant actors and relations in this target population.