Moving toward precision in prenatal evidence-based home visiting to achieve good birth outcomes: assessing the alignment of local programs with their national models.

BACKGROUND: Low birthweight and preterm birth rates are higher in the United States than in other developed countries and exhibit pronounced racial inequities. Home visiting is a strategy to promote equity in birth outcomes. Research points to precision home visiting as the path to equity. The purpose of this study is to describe local programs' risk reduction priorities, intended behavioral pathways, and expectations of home visitors; compare these local program features with those of their national model; and assess the strength of implementation systems to support staff in meeting job expectations. METHODS: We surveyed local programs implementing one of four evidence-based home visiting models that aim to promote good birth outcomes: Family Spirit, Healthy Families America, Nurse-Family Partnership, and Parents as Teachers. RESULTS: Representatives from 169 local programs completed the survey. Overall, 59% endorsed all their model's high priority risks, 16% endorsed all its required behavioral pathways, and 11% endorsed all its required techniques. Local programs went beyond their national model's explicit intentions. Overall, 91% of local programs prioritized risks beyond those of their model, 85% endorsed behavioral pathways beyond those of their model, 95% endorsed visitors' use of techniques not explicitly endorsed by their model but compatible with it, and 19% endorsed use of techniques judged incompatible by their model. Implementation system strength was positively associated with local program and model expectations. CONCLUSIONS: Precision home visiting to achieve health equity requires shared learning of what works best for whom. This observational study showed the Precision Paradigm's usefulness for cross-model research to advance precision.

Service Coordination in Early Childhood Home Visiting: a Multiple-Case Study.

Early childhood home visiting is a preventive service delivery strategy that aims to promote child and parent health, positive parenting, child development and school readiness, and family economic self-sufficiency. To meet families' needs, programs provide a combination of direct services, and referrals and linkages to community-based services. Service coordination is therefore a critical component of home visiting's role within the early childhood system of care. This multiple-case study describes facilitators and barriers to service coordination, as identified by home visiting program staff and families. We interviewed program managers, supervisors, home visitors, and families from four local home visiting programs in the eastern USA with diverse contextual characteristics that showed evidence of having strong coordination. Using multiple-case study methodology, we analyzed the data to understand key facilitators and barriers to service coordination for each case and identify and describe common themes across cases. Facilitators included interagency relationships and collaboration; a culture of teamwork; dedicated, well-connected staff; supervision; trusting relationships with families; and warm handoffs. Barriers to service coordination were limited availability and accessibility of local resources, perceived stigma among other service providers, and families' ambivalence toward some services. Home visiting staff and families emphasized that relationships at multiple levels are fundamental to service coordination, barriers are complex, and coordination is time- and labor-intensive. Coalitions that bring together diverse stakeholder groups at the state and local levels can provide meaningful coordination support to the early childhood services.

Referrals to Home Visiting: Current Practice and Unrealized Opportunities.

INTRODUCTION: Evidence supports ongoing investment in maternal and early childhood home visiting in the US. Yet, a small fraction of eligible families accesses these services, and little is known about how families are referred. This report describes priority populations for home visiting programs, the capacity of programs to enroll more families, common sources of referrals to home visiting, and sources from which programs want to receive more referrals. METHODS: We conducted a secondary analysis of data from a national web-based survey of members of the Home Visiting Applied Research Collaborative (HARC), focusing on a small set of items that directly addressed study aims. Survey respondents (N = 87) represented local programs implementing varying home visiting models diverse in size and geographic context. RESULTS: Programs prioritized enrollment of pregnant women; parents with mental health, substance abuse or intimate partner violence concerns; teen parents; and children with developmental delays or child welfare involvement. Most respondents reported capacity to enroll more families in their programs. Few reported receiving any referrals from pediatric providers, child welfare, early care and education, or TANF/other social services. Most desired more referrals, especially from healthcare providers, WIC, and TANF/other social services. DISCUSSION: Given that most programs have the capacity to serve more families, this study provides insights regarding providers with whom home visiting programs might strengthen their referral systems.

Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common pelvic floor disorders (PFDs). Owing to significant adverse events associated with mesh-related pelvic floor procedures (PFPs) in a proportion of the surgically treated population, and deficits in collection and reporting of these events, the Australian Government identified an urgent need for a tracking mechanism to improve safety and quality of care. The Australasian Pelvic Floor Procedure Registry (APFPR) was recently established following the 2018 Senate Committee Inquiry with the aim of tracking outcomes of PFP involving the use of devices and/or prostheses, with the objective of improving the health outcomes of women who undergo these procedures. This paper will describe the APFPR's aims, development, implementation and possible challenges on the way to its establishment. METHODS: The APFPR has been developed and implemented in accordance with the national operating principles of clinical quality registries (CQRs). The minimum datasets (MDS) for the registry's database have been developed using a modified Delphi process, and data are primarily being collected from participating surgeons. Patient recruitment is based on an opt-out approach or a waiver of consent. Patient-reported outcome measures (PROMs) providing additional health and outcome information will be obtained from participating women to support safety monitoring of mesh-related adverse events. RESULTS: Currently in the Australasian Pelvic Floor Procedure Registry (APFPR) there are 32 sites from various jurisdictions across Australia, that have obtained relevant ethics and governance approvals to start patient recruitment and data collection as of January 2023. Additionally, there are two sites that are awaiting governance review and five sites that are having documentation compiled for submission. Seventeen sites have commenced patient registration and have entered data into the database. Thus far, we have 308 patients registered in the APFPR database. The registry also published its first status report and a consumer-friendly public report in 2022. CONCLUSIONS: The registry will act as a systematic tracking mechanism by collecting outcomes on PFP, especially those involving devices and/or prostheses to improve safety and quality of care.

Tbx2 is a master regulator of inner versus outer hair cell differentiation.

The cochlea uses two types of mechanosensory cell to detect sounds. A single row of inner hair cells (IHCs) synapse onto neurons to transmit sensory information to the brain, and three rows of outer hair cells (OHCs) selectively amplify auditory inputs1. So far, two transcription factors have been implicated in the specific differentiation of OHCs, whereas, to our knowledge, none has been identified in the differentiation of IHCs2-4. One such transcription factor for OHCs, INSM1, acts during a crucial embryonic period to consolidate the OHC fate, preventing OHCs from transdifferentiating into IHCs2. In the absence of INSM1, embryonic OHCs misexpress a core set of IHC-specific genes, which we predict are involved in IHC differentiation. Here we find that one of these genes, Tbx2, is a master regulator of IHC versus OHC differentiation in mice. Ablation of Tbx2 in embryonic IHCs results in their development as OHCs, expressing early OHC markers such as Insm1 and eventually becoming completely mature OHCs in the position of IHCs. Furthermore, Tbx2 is epistatic to Insm1: in the absence of both genes, cochleae generate only OHCs, which suggests that TBX2 is necessary for the abnormal transdifferentiation of INSM1-deficient OHCs into IHCs, as well as for normal IHC differentiation. Ablation of Tbx2 in postnatal, largely differentiated IHCs makes them transdifferentiate directly into OHCs, replacing IHC features with those of mature and not embryonic OHCs. Finally, ectopic expression of Tbx2 in OHCs results in their transdifferentiation into IHCs. Hence, Tbx2 is both necessary and sufficient to make IHCs distinct from OHCs and maintain this difference throughout development.

Changing the home visiting research paradigm: models' perspectives on behavioral pathways and intervention techniques to promote good birth outcomes.

BACKGROUND: The US is scaling up evidence-based home visiting to promote health equity in expectant families and families with young children. Persistently small average effects for full models argue for a new research paradigm to understand what interventions within models work best, for which families, in which contexts, why, and how. Historically, the complexity and proprietary nature of most evidence-based models have been barriers to such research. To address this, stakeholders are building the Precision Paradigm, a common framework and language to define and test interventions and their mediators and moderators. This observational study used portions of an early version of the Precision Paradigm to describe models' intended behavioral pathways to good birth outcomes and their stance on home visitors' use of specific intervention technique categories to promote families' progress along intended pathways. METHODS: Five evidence-based home visiting models participated. Model representatives independently completed three structured surveys focused on 41 potential behavioral pathways to good birth outcomes, and 23 behavior change technique categories. Survey data were used to describe and compare models' intended behavioral pathways, explicit endorsement of behavior change technique categories, expectations for home visitors' relative emphasis in using endorsed technique categories, and consistency in endorsing technique categories across intended pathways. RESULTS: Models differed substantially in nearly all respects: their intended pathways to good birth outcomes (range 16-41); the number of technique categories they endorsed in any intended pathway (range 12-23); the mean number of technique categories they endorsed per intended pathway (range 1.5-20.0); and their consistency in endorsing technique categories across intended pathways (22%-100% consistency). Models were similar in rating nearly all behavior change technique categories as at least compatible with their model, even if not explicitly endorsed. CONCLUSIONS: Models successfully used components of the Precision Paradigm to define and differentiate their intended behavioral pathways and their expectations for home visitors' use of specific technique categories to promote family progress on intended pathways. Use of the Precision Paradigm can accelerate innovative cross-model research to describe current models and to learn which interventions within home visiting work best for which families, in which contexts, why and how.

Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE.

OBJECTIVES: To investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound. METHODS: The randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses. RESULTS: Of the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [-9 (0.9) vs -6 (0.9), difference (95% CI): -3 (-6, -1); one-sided P=0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported. CONCLUSION: This unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02662985.

Improving Outcomes for Families of Children With Medical Needs Known to Child Welfare: A Nurse Care Coordination Program.

Children known to child welfare are more likely to have poor health compared to the general population. Most children served by child welfare are served in their own homes. New Jersey implemented the Child and Family Nurse Program (CFNP) to provide nurse care coordination to address the health needs of children who remain in-home. Our study described: 1) families served by CFNP; 2) services provided to these families; and 3) family well-being outcomes. The study focused on the 304 families served by CFNP from 2016 to 2017. We used CFNP data to describe families served and services provided, and family baseline and follow-up surveys to assess change in family well-being over time. Families served by CFNP experienced improvements in family protective factors and health-related quality of life from baseline to follow-up. While more rigorous studies are needed to learn CFNP's impact, it is a promising approach that merits consideration by state child welfare leaders.

The Role of Open Science Practices in Scaling Evidence-Based Prevention Programs.

The goal of creating evidence-based programs is to scale them at sufficient breadth to support population-level improvements in critical outcomes. However, this promise is challenging to fulfill. One of the biggest issues for the field is the reduction in effect sizes seen when a program is taken to scale. This paper discusses an economic perspective that identifies the underlying incentives in the research process that lead to scale up problems and to deliver potential solutions to strengthen outcomes at scale. The principles of open science are well aligned with this goal. One prevention program that has begun to scale across the USA is early childhood home visiting. While there is substantial impact research on home visiting, overall average effect size is .10 and a recent national randomized trial found attenuated effect sizes in programs implemented under real-world conditions. The paper concludes with a case study of the relevance of the economic model and open science in developing and scaling evidence-based home visiting. The case study considers how the traditional approach for testing interventions has influenced home visiting's evolution to date and how open science practices could have supported efforts to maintain impacts while scaling home visiting. It concludes by considering how open science can accelerate the refinement and scaling of home visiting interventions going forward, through accelerated translation of research into policy and practice.

Service Coordination to Address Maternal Mental Health, Partner Violence, and Substance Use: Findings from a National Survey of Home Visiting Programs.

Maternal risks such as poor mental health, partner violence, and substance misuse can undermine child health and development. Maternal and early childhood home visiting programs address these risks primarily through referral and coordination with community-based services, yet effects on these outcomes have been small. This study assessed the strengths of local home visiting sites' systems to support coordination of mental health, partner violence, and substance use services. Investigators recruited home visiting sites (N = 88) representing diverse models from a national practice-based research network, the Home Visiting Applied Research Collaborative (HARC). Web-based surveys assessed five implementation system supports for coordination and nine coordination activities drawn from the Measurement Framework for Coordination developed earlier in the project. Surveys also assessed seven coordination barriers identified in previous research. Sites varied in their implementation supports and coordination activities; on average, sites had stronger systems in place to support screening and referring families than to support linkage and follow-up. Implementation supports and activity scores were higher for mental health and partner violence than for substance use. Across all service needs, scores were highest for offering a referral and documenting the caregiver's agreement for exchange of information between providers. Scores were lowest for offering a warm handoff. Lack of open slots and lack of transportation were major barriers to successful coordination for all three services. Results suggest that home visiting coordination could be strengthened by focusing on infrastructure for linkage and follow-up with services in the broader system of care.

Impact of COVID-19 pandemic on utilisation of healthcare services: a systematic review.

OBJECTIVES: To determine the extent and nature of changes in utilisation of healthcare services during COVID-19 pandemic. DESIGN: Systematic review. ELIGIBILITY: Eligible studies compared utilisation of services during COVID-19 pandemic to at least one comparable period in prior years. Services included visits, admissions, diagnostics and therapeutics. Studies were excluded if from single centres or studied only patients with COVID-19. DATA SOURCES: PubMed, Embase, Cochrane COVID-19 Study Register and preprints were searched, without language restrictions, until 10 August, using detailed searches with key concepts including COVID-19, health services and impact. DATA ANALYSIS: Risk of bias was assessed by adapting the Risk of Bias in Non-randomised Studies of Interventions tool, and a Cochrane Effective Practice and Organization of Care tool. Results were analysed using descriptive statistics, graphical figures and narrative synthesis. OUTCOME MEASURES: Primary outcome was change in service utilisation between prepandemic and pandemic periods. Secondary outcome was the change in proportions of users of healthcare services with milder or more severe illness (eg, triage scores). RESULTS: 3097 unique references were identified, and 81 studies across 20 countries included, reporting on >11 million services prepandemic and 6.9 million during pandemic. For the primary outcome, there were 143 estimates of changes, with a median 37% reduction in services overall (IQR -51% to -20%), comprising median reductions for visits of 42% (-53% to -32%), admissions 28% (-40% to -17%), diagnostics 31% (-53% to -24%) and for therapeutics 30% (-57% to -19%). Among 35 studies reporting secondary outcomes, there were 60 estimates, with 27 (45%) reporting larger reductions in utilisation among people with a milder spectrum of illness, and 33 (55%) reporting no difference. CONCLUSIONS: Healthcare utilisation decreased by about a third during the pandemic, with considerable variation, and with greater reductions among people with less severe illness. While addressing unmet need remains a priority, studies of health impacts of reductions may help health systems reduce unnecessary care in the postpandemic recovery. PROSPERO REGISTRATION NUMBER: CRD42020203729.

Head of bed elevation to relieve gastroesophageal reflux symptoms: a systematic review.

BACKGROUND: Overuse of proton pump inhibitors (PPIs) - frequently used for relieving symptoms of gastroesophageal reflux disease (GORD) - raises long-term safety concerns, warranting evidence-based non-drug interventions. We conducted a systematic review to evaluate the effect of head-of-bed elevation on relieving symptoms of GORD in adults. METHODS: We included controlled trials comparing the effect of head-of-bed elevation interventions to control in adults with GORD. Two independent reviewers screened articles, extracted data, and assessed quality of included studies. Primary outcomes were changes in GORD symptoms and use of PPIs. RESULTS: We screened 1206 records; and included five trials (four cross-over and one factorial) comprising 228 patients. All five included trials were judged to be at high-risk of performance bias and four of selection bias. Of five included trials, two used 'bed blocks' under the bed legs; one used 'sleeping on a wedge' pillow, and two used both. High heterogeneity in outcome measures and reported outcomes data precluded meta-analyses. The four studies that reported on GORD symptoms found an improvement among participants in the head-of-bed elevation; a high-quality crossover trial showed a clinical important reduction in symptom scores at 6 weeks (risk ratio of 2.1; 95% CI 1.2 to 3.6). These results are supported by the observed improvement in physiological intra-oesophageal pH measurements. CONCLUSIONS: Methodological and reporting limitations in available literature preclude definitive recommendations. However, head-of-bed elevation could be still considered as a cheap and safe alternative to drug interventions with unfavourable safety profiles. PROTOCOL REGISTRATION: Open Science Framework: http://osf.io/2hz3j.

Does Child Likeability Mediate the Link Between Academic Competence and Depressive Symptoms in Early Elementary School?

The present study investigated the role of teacher-rated likeability as a mediator of the relation between low academic competence and depressive symptoms in elementary-aged children. Analyses focused on a sample of children at risk for child maltreatment living in Hawaii (n = 380). Structural equation modeling supported the hypothesized negative relations between academic competence in first grade and depressive symptoms in third grade controlling for correlated constructs (e.g., baseline social avoidance, parenting stress, externalizing problems, and internalizing symptoms). Teacher-rated likeability in second grade negatively mediated the effect of academic competence on depressive symptoms. Implications for understanding the role of early academic skill deficits and social judgments on risk for depressive symptoms as well as recommendations for interventions and prevention strategies are discussed.

Impact of a Child Abuse Primary Prevention Strategy for New Mothers.

First Steps (FS) is a brief obstetrics-based primary prevention strategy that aims to strengthen protective factors to prevent child maltreatment. This randomized controlled trial assessed how well FS services aligned with family interests and needs, how FS providers used communication strategies to build partnership with mothers, and the impact of FS on mothers' parenting knowledge in core content areas and access to services. Mothers completed a baseline survey and were randomly assigned to FS and control conditions (n = 374 and 375, respectively). The parenting education services provided to mothers were assessed by independent participant report immediately postintervention for the full FS group and by analysis of audio-recordings of the FS encounter for a subsample (n = 150). Outcomes were measured at 4 months via maternal survey. Compared to controls at follow-up, FS mothers had significantly higher knowledge scores in some areas but similar access to needed services. Few mothers lacked access to most services at baseline, and FS content was similar to that provided by other hospital personnel. FS providers' communication style promoted rapport, but providers did not tailor content to mothers' educational and service access needs. Implications of the findings for similar services are discussed.

The Role of State Context in Promoting Service Coordination in Maternal, Infant, and Early Childhood Home Visiting Programs.

CONTEXT: The federal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program provides funding to states to promote health and development of at-risk expectant families and families with young children. MIECHV programs are required to coordinate services within a larger system of care; yet, little is known about state-level factors that support coordination. OBJECTIVE: This study examined state-level supports and barriers for coordination of home visiting with other entities within the early childhood system of care. METHODS: A Web-based survey was distributed in 2016 via e-mail to MIECHV administrators in all 50 states, 5 US territories, and the District of Columbia. The survey elicited information on 5 domains shown by theory and prior research to support coordination: MIECHV leadership, state leadership, shared goals across sectors, data systems, and finance. Respondents also rated their perceptions of state-level coordination. RESULTS: Forty-two (75%) of the MIECHV administrators participated in the survey. States and territories varied widely within and across the 5 domains of support for coordination. MIECHV leadership was an area of relative strength, whereas data systems and finance showed the most room for improvement. State leadership and shared goals were associated with stronger perceptions of state-level coordination. CONCLUSIONS: The findings indicate opportunities for shared learning among states to enhance coordination infrastructure. Such efforts should include multiple stakeholder perspectives and consideration of local and organizational contexts. This work could be facilitated using the service coordination toolkit developed as part of this project.

Innovative Research Methods to Advance Precision in Home Visiting for More Efficient and Effective Programs.

Home visiting during early childhood can improve a range of outcomes for children and families. As evidence-based models are implemented across the nation, two questions have emerged. First, can home visiting improve outcomes more efficiently? Second, can overall effects be strengthened for specific subgroups of families? For the past several decades, research focused on testing the average effects of home visiting models on short- to long-term outcomes has found small impacts. These effects are not the same for all families. The field needs new evidence produced in new ways to overcome these challenges. In this article, we provide an overview of the evidence in this field, including what works and for whom. Next, we explain precision approaches to various fields and how this approach could be used in home visiting programs. Research on precision home visiting focuses on the ingredients of home visiting models, collaborating with practitioners to identify the ingredients and testing them on near-term outcomes, and using innovative study designs to learn more quickly what works best for which families. We conclude by proposing four pillars of research that will help achieve precision home visiting services.

Biomarkers of collagen synthesis predict progression in the PROFILE idiopathic pulmonary fibrosis cohort.

Idiopathic pulmonary fibrosis (IPF) is characterised by excessive extracellular matrix (ECM) deposition and remodelling. Measuring this activity provides an opportunity to develop tools capable of identifying individuals at-risk of progression. Longitudinal change in markers of ECM synthesis was assessed in 145 newly-diagnosed individuals with IPF.Serum levels of collagen synthesis neoepitopes, PRO-C3 and PRO-C6 (collagen type 3 and 6), were elevated in IPF compared with controls at baseline, and progressive disease versus stable disease during follow up, (PRO-C3 p < 0.001; PRO-C6 p = 0.029). Assessment of rate of change in neoepitope levels from baseline to 3 months (defined as 'slope to month 3': HIGH slope, slope > 0 vs. LOW slope, slope < =0) demonstrated no relationship with mortality for these markers (PRO-C3 (HR 1.62, p = 0.080); PINP (HR 0.76, p = 0.309); PRO-C6 (HR 1.14, p = 0.628)). As previously reported, rising concentrations of collagen degradation markers C1M, C3M, C6M and CRPM were associated with an increased risk of overall mortality (HR = 1.84, CI 1.03-3.27, p = 0.038, HR = 2.44, CI 1.39-4.31, p = 0.002; HR = 2.19, CI 1.25-3.82, p = 0.006; HR = 2.13 CI 1.21-3.75, p = 0.009 respectively).Elevated levels of PRO-C3 and PRO-C6 associate with IPF disease progression. Collagen synthesis and degradation biomarkers have the potential to enhance clinical trials in IPF and may inform prognostic assessment and therapeutic decision making in the clinic.

Author Correction: Trans-differentiation of outer hair cells into inner hair cells in the absence of INSM1.

In Figs. 1e and 2g of this Letter, the labels 'actin' and 'VGLUT3', respectively, should have been in red instead of green font. This has been corrected online.