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The herd veterinarian has an important role on calf raising op­erations to promote the health and welfare of calves through having a role in the milk phase nutrition program. Optimal nutrition will benefit the calves and the herd veterinarian can help provide input and critique of a milk program using their expertise in animal health, husbandry, nutrition and behav­ior. Milk feeding of calves, traditionally around 60 days, has been shown to have long term production benefits for adult dairy cows, and yet often the milk feeding plan is delegated to a private or feed company nutritionist. This paper describes tools and best practices for herd veterinarians to ensure young calves are fed appropriately to meet their genetic potential and the dairy producer’s goals. Even if the herd veterinarian does not have overall authority of a milk program, they can use the best practices to align producer expectations with what is be­ing offered to the calves and give their impartial input of how to best apply the producer’s resources in a feeding program for the benefit of the calves.

Background Paradoxical adipose hyperplasia (PAH), a rare side effect of CoolSculpting (cryolipolysis), is characterized by fatty enlargement of the treatment area occurring months after the procedure. Objectives The purpose of this study was to report a retrospective case series of patients diagnosed with PAH at the authors’ institution, increase the collective understanding of this complication and subsequent management, and raise the question of who should ethically perform cryolipolysis. Methods All participants diagnosed with PAH by a plastic surgeon at a large academic medical center were identified. Demographic information, medical history, procedure details, time to PAH diagnosis, and corrective surgical intervention details were collected. Mean duration of time from cryolipolysis treatment to diagnosis of PAH was calculated, along with other descriptive statistics. A scoping review of all PAH literature published in PubMed, Embase, and Web of Science was also conducted. Results Four patients diagnosed with PAH after cryolipolysis were identified for inclusion in this study. The calculated incidence of PAH at our center was 0.67%. All patients requested therapy for PAH and subsequently underwent either liposuction, abdominoplasty, or both. The mean duration of in-person follow-up time after final surgical treatment of PAH was 13.8 + 19.8 months (range, 2.8-43.5). Fortunately, no patients showed signs of PAH recurrence, and 3 out of 4 patients did not show signs of residual deformity. Conclusions Findings from this patient cohort and scoping review provide evidence that although revisions may be required, conventional body contouring methods, not in the armamentarium of non-plastic surgeon practitioners, effectively alleviated PAH. Level of Evidence: 4

Objectives Our objective was to evaluate the effects of benzathine cloxacillin (BC) and ceftiofur hydrochloride (CH) treatment at dry-off on prevalence of intramammary infections at calving, incidence of clinical mastitis and SCC and milk yield up to 100 DIM, and removal from the herd and reproductive responses within 100 DIM. Materials and Methods At dry-off, cows from 2 herds were assigned randomly to the BC (n = 1,160; Orbenin-DC, Merck Animal Health) and the CH (n = 1,183; Spectramast DC, Zoetis) treatments. Composite milk samples collected at dry-off and at calving were submitted for bacterial culture. Monthly milk samples were used to determine SCC. Days in milk at first insemination and pregnancy outcomes to first and second inseminations were compared between the 2 treatments. Results and Discussion Treatments did not differ regarding prevalence of intramammary infections at dry-off (BC = 45.2 ± 1.8% vs. CH = 42.6 ± 1.7%). Treatment did not affect the prevalence of intramammary infections at calving (BC = 39.1 ± 2.3% vs. CH = 40.4 ± 2.3%), incidence of clinical mastitis within 100 DIM (BC = 6.6 ± 1.0% vs. CH = 7.7 ± 1.1%), and milk yield up to 100 DIM (BC = 3.6 ± 0.03 kg × 103 vs. CH = 3.6 ± 0.03 kg × 103). Treatment did not affect reproductive outcomes. Implications and Applications Producers may choose between BC and CH at dry-off without being concerned about differences in prevalence of IMI at calving and lactational performance.

Over half of patients with type 2 diabetes (T2D) are unable to achieve blood glucose targets despite therapeutic compliance, significantly increasing their risk of long-term complications. Discovering ways to identify and properly treat these individuals is a critical problem in the field. The arachidonic acid metabolite, prostaglandin E

Human papillomavirus (HPV) vaccination could prevent most of the ~34,000 HPV-attributable cancers diagnosed annually in the US, but uptake remains suboptimal. Healthcare systems are key partners in implementing HPV vaccination quality improvement (QI) programs. To inform future system-level HPV vaccine initiatives, we sought to understand HPV vaccine QI from the perspective of QI program leaders in healthcare systems. We conducted telephone interviews with a multi-state sample of 17 QI leaders in 15 systems. We analyzed data qualitatively via thematic analysis to describe QI leaders' perspectives on prioritizing and implementing HPV vaccine QI. All QI leaders endorsed HPV vaccination as beneficial, and some had already prioritized increasing uptake to improve adolescent health and meet payor reimbursement standards. Those not prioritizing HPV vaccination cited concerns including the relatively small size of adolescent patient populations, lack of buy-in among providers, and the need to focus on health services perceived as more profitable or urgent. When implementing HPV vaccine QI programs, QI leaders reported key barriers to be the lack of robust data systems and acceptable QI metrics, limited time, and pressures of a fee-for-service clinical environment. Facilitators included automation and standardization in QI efforts and passionate vaccine champions. Almost all QI leaders reported future plans to implement HPV vaccine QI projects. Findings suggest that many healthcare systems are motivated to improve HPV vaccination. However, resistance to guideline-consistent quality metrics, the narrow target of one vaccine in the adolescent patient population, payment structures, and constrained time of providers are key barriers to practice improvements.

We and others previously reported increased signaling through the Prostaglandin E3 Receptor (EP3), a G protein-coupled receptor (GPCR) for the arachidonic acid metabolite, prostaglandin E2 (PGE2), is associated with {beta}-cell dysfunction of type 2 diabetes (T2D). Yet, the relationship between PGE2 production and signaling and {beta}-cell function during the progression to T2D remains unclear. In this work, we assessed gene expression from a panel of cadaveric human islets from 40 non-diabetic donors with BMI values spanning the spectrum from lean to high-risk obesity. Interleukin-6 (gene symbol: IL6) and cyclooxygenase-2 (COX-2) (gene symbol: PTGS2) mRNA levels were positively correlated with donor body mass index (BMI), while EP3 (gene symbol: PTGER3) was not. IL6 was itself strongly correlated with PTGS2 and all but one of the other PGE2 synthetic pathway genes tested. About half of the islet preparations were used in glucose-stimulated- and incretin-potentiated insulin secretion assays using an EP3-specific antagonist, confirming functionally-relevant up-regulation of PGE2 production. Islets from obese donors showed no inherent {beta}-cell dysfunction and were at least equally as glucose- and incretin-responsive as islets from non-obese donors. Furthermore, insulin content, a marker of islet size known to be associated with donor BMI, was also significantly and positively correlated with islet PTGS2 expression. We conclude up-regulated islet PGE2 production and signaling may be a necessary part of the {beta}-cell adaption response, compensating for obesity and insulin resistance. Analysis of plasma PGE2 metabolite levels from a clinical cohort reveal these findings are not in conflict with the concept of further elevations in PGE2 production contributing to T2D-related {beta}-cell dysfunction where islet EP3 expression has also been up-regulated. Graphical Abstract O_FIG O_LINKSMALLFIG WIDTH=126 HEIGHT=200 SRC="FIGDIR/small/429205v1_ufig1.gif" ALT="Figure 1"> View larger version (25K): org.highwire.dtl.DTLVardef@14056a7org.highwire.dtl.DTLVardef@f8fcf1org.highwire.dtl.DTLVardef@a66915org.highwire.dtl.DTLVardef@13ce208_HPS_FORMAT_FIGEXP M_FIG C_FIG

BACKGROUND AND OBJECTIVES Hospitalized children with medical complexity (CMC) are at high risk of medical errors. Their families are an underutilized source of hospital safety data. We evaluated safety concerns from families of hospitalized CMC and patient/parent characteristics associated with family safety concerns. METHODS We conducted a 12-month prospective cohort study of English- and Spanish-speaking parents/staff of hospitalized CMC on 5 units caring for complex care patients at a tertiary care children’s hospital. Parents completed safety and experience surveys predischarge. Staff completed surveys during meetings and shifts. Mixed-effects logistic regression with random intercepts controlling for clustering and other patient/parent factors evaluated associations between family safety concerns and patient/parent characteristics. RESULTS A total of 155 parents and 214 staff completed surveys (>89% response rates). 43% (n = 66) had ≥1 hospital safety concerns, totaling 115 concerns (1–6 concerns each). On physician review, 69% of concerns were medical errors and 22% nonsafety-related quality issues. Most parents (68%) reported concerns to staff, particularly bedside nurses. Only 32% of parents recalled being told how to report safety concerns. Higher education (adjusted odds ratio 2.94, 95% confidence interval [1.21–7.14], P = .02) and longer length of stay (3.08 [1.29–7.38], P = .01) were associated with family safety concerns. CONCLUSIONS Although parents of CMC were infrequently advised about how to report safety concerns, they frequently identified medical errors during hospitalization. Hospitals should provide clear mechanisms for families, particularly of CMC and those from disadvantaged backgrounds, to share safety concerns. Actively engaging patients/families in reporting will allow hospitals to develop a more comprehensive, patient-centered view of safety.

PURPOSE: Families play a key role in managing chronic illness. Among chronically ill children, we describe the Patient-Reported Outcomes Measurement Information System (PROMIS) Family Relationships measure over time and its associations with sociodemographics, environmental deprivation, and health. METHODS: Parents of children aged 8-18 years with asthma (n=171), type 1 diabetes (n=199), or sickle cell disease (n=135), recruited in pediatric clinics and emergency departments (ED), completed demographic surveys. Every six months for up to three years, children completed PROMIS Family Relationships, Anxiety, and Depressive Symptoms short forms (T-scores; mean 50, SD=10), and a 5-level health status item. Linear mixed models were fit to estimate associations. RESULTS: Older baseline age was associated with weaker family relationships. For example, for each 3-year higher baseline age, relationships were 3-points weaker for males (−3.0; 95%CI −5.7 to −.0.2) and females (−3.1; 95%CI −6.0 to −0.3) with asthma recruited in the ED. For each 1-unit higher mean overall health, relationships were 4.6 points (95%CI 3.2-6.1) stronger for children with diabetes and about 2 points stronger for children with asthma (2.3; 0.7-3.9) and sickle cell disease (2.1; 0.3-3.9). Family relationships were 0.3-0.5 points weaker for each 1-unit increment in mean anxiety or depressive symptoms across all three diseases. Relationships were not significantly associated with environmental deprivation and generally stable over time. CONCLUSIONS: Family relationships were weaker among older children and generally stable over time, yet fluctuated with physical and mental health. Monitoring PROMIS Family Relationships scores may facilitate referrals for chronically ill children who need support.

Introduction We explored differences in Health-Related Quality of Life (HRQOL) and the youth's glycosylated hemoglobin (A1c) of preadolescent and adolescent youths with type 1 diabetes (T1D) by individual (age, sex, race) and family (socioeconomic status) factors, and associations between youths’ HRQOL, their parents’ HRQOL, and youth's A1c. Method Correlational secondary analysis of baseline data from a randomized controlled trial testing a developmental intervention for youths with T1D and their parents from two diabetes clinics. Results Better adolescent HRQOL was associated with better glycemic control. Better preadolescent HRQOL was associated with better parent HRQOL. Non-White adolescents had worse HRQOL than White adolescents; whereas Non-White preadolescents had worse glycemic control than White preadolescents. Discussion Addressing HRQOL may promote better glycemic control in adolescents with T1D. For preadolescents with T1D, parent HRQOL support may impact preadolescent HRQOL and improve glycemic control moving into adolescence. Further study is warranted for non-White youths with T1D HRQOL and A1c outcomes.

Metabolomics-the endpoint of the omics cascade-is increasingly recognized as a preferred method for understanding the ultimate responses of biological systems to stress. Flow injection electrospray (FIE) mass spectrometry (MS) has advantages for untargeted metabolic fingerprinting due to its simplicity and capability for high-throughput screening but requires a high-resolution mass spectrometer to resolve metabolite features. In this study, we developed and validated a high-throughput and highly reproducible metabolomics platform integrating FIE with ultrahigh-resolution Fourier transform ion cyclotron resonance (FTICR) MS for analysis of both polar and nonpolar metabolite features from plasma samples. FIE-FTICR MS enables high-throughput detection of hundreds of metabolite features in a single mass spectrum without a front-end separation step. Using plasma samples from genetically identical obese mice with or without type 2 diabetes (T2D), we validated the intra and intersample reproducibility of our method and its robustness for simultaneously detecting alterations in both polar and nonpolar metabolite features. Only 5 min is needed to acquire an ultra-high resolution mass spectrum in either a positive or negative ionization mode. Approximately 1000 metabolic features were reproducibly detected and annotated in each mouse plasma group. For significantly altered and highly abundant metabolite features, targeted tandem MS (MS/MS) analyses can be applied to confirm their identity. With this integrated platform, we successfully detected over 300 statistically significant metabolic features in T2D mouse plasma as compared to controls and identified new T2D biomarker candidates. This FIE-FTICR MS-based method is of high throughput and highly reproducible with great promise for metabolomics studies toward a better understanding and diagnosis of human diseases.

Sinusoidal obstruction syndrome (SOS) is a serious complication of hematopoietic stem cell transplantation (HSCT). Sirolimus plus tacrolimus is an accepted regimen for graft-versus-host disease (GVHD) prophylaxis, with both agents implicated as risk factors for SOS. We analyzed 260 consecutive patients who underwent allogeneic HSCT following myeloablative conditioning using total body irradiation (TBI)-based (n = 151) or chemotherapy only (n = 109) regimens, with sirolimus plus tacrolimus for GVHD prophylaxis. SOS occurred in 28 patients at a median of 22 (range, 12–58) days. Mean sirolimus trough levels were higher between days 11 and 20 following transplant in patients who developed SOS (10.3 vs. 8.5 ng/ml, P = 0.008), with no significant difference in mean trough levels between days 0 and 10 (P = 0.67) and days 21–30 (P = 0.37). No differences in mean tacrolimus trough levels during the same time intervals were observed between those developing SOS and others. On multivariable analysis, a mean sirolimus trough level ≥ 9 ng/ml between days 11 and 20 increased the risk of SOS (hazard ratio 3.68, 95% CI: 1.57–8.67, P = 0.003), together with a longer time from diagnosis to transplant (P = 0.004) and use of TBI (P = 0.006). Our results suggest that mean trough sirolimus levels ≥ 9 ng/mL between days 11 and 20 post transplant may increase the risk of SOS and should be avoided.

Background Postpartum depression (PPD) is a common and gravely disabling health concern. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for major depression and may be a valuable tool in the treatment of PPD. The treatment effect of rTMS is rapid, generally well tolerated, without systemic effects, and without medication exposure to a fetus and/or breastfed infant. Methods Six women with PPD received 20 sessions of 10 Hz rTMS over the left dorsolateral prefrontal cortex (DLPFC) over a 4 week period. Psychiatric rating scales (BDI, EPDS, STATI), cognitive assessments (MMSE, Trails B, List Generation) and breastfeeding practices were surveyed at baseline and post rTMS treatment. BDI and EPDS were obtained weekly, as well as 3 months and 6 months post study conclusion. Results Average BDI, EPDS, and STAI scores declined over the 4-week duration of rTMS treatment. Of the six patients, four achieved remission as assessed by EPDS and one achieved remission and two responded as assessed by BDI. Mean BDI and EPDS scores at 3 and 6 months follow-up remained below levels at study entry. No evidence of cognitive changes or breastfeeding disruptions. Limitations This was an exploratory study with small sample size with no sham control arm. Daily administration of rTMS provides potential for confounding of behavioral activation in the otherwise often isolative postpartum period. Conclusions rTMS was safe and well tolerated among participants with evidence of sustained improvements in depression and anxiety scores. This study supports rTMS as a promising non-pharmacologic treatment modality for perinatal depression.

Objective: To optimize type 1 diabetes (T1D) self-management, experts recommend tailoring care to meet people’s needs and preferences. To facilitate this tailoring, we developed and validated the Barriers and Supports Evaluation (BASES) tool to identify working-age adults’ T1D self-management barriers and supports. Methods: Participants were 25-64 year old adults with T1D recruited from clinics and a community-based registry. Guided by Social Cognitive Theory, content analysis of 33 semi-structured interviews was used to create a comprehensive item pool of 136 items, further refined to 70 candidate items on a 5-point Likert scale through cognitive interviewing and pilot testing. To develop and validate the tool, exploratory and confirmatory factor analyses were applied to 392 participants’ survey responses to the candidate barrier and support items. Additional survey data included demographics and the Diabetes-Specific Quality of Life Scale-Revised. To evaluate concurrent validity, A1c values from medical records and quality of life (QoL) scores were regressed on domain scores. Results: Factor analyses yielded 5 domains with a total of 30 items: (1) Cognitive Processes, (2) Costs and Insurance, (3) Learning Opportunities, (4) Family and Friend Support, and (5) Diabetes Provider Interactions. Models exhibited good to adequate fit, with Comparative Fit Index (CFI)>0.88 and Root Mean Squared Error of Approximation (RMSEA) Conclusions: The BASES tool is brief, patient-centered, and demonstrates construct and concurrent validity. The tool could be used in clinical practice to tailor diabetes support and education to individual’s needs, improving effectiveness of services. Disclosure E. D. Cox: None. E. M. Planalp: None. H. Kliems: None. M. Palta: n/a. T. J. Lecaire: None. B. A. Chewning: None. Funding American Diabetes Association (1-18-ICTS-026 to E.D.C.)

We report forensic analysis of a case study of a skylight fall incident. We also replicated a hazard detection technique in the current case that we had previously employed in a similar case. In the hazard detection method, participants were asked to rate how hazardous each of eight photographs of a site visit scene appeared, and to identify any hazards present. Hazard ratings varied significantly across scenes, but no participant identified skylights as a hazard, replicating our previous findings and confirming site visit assessments. Flat-panel warehouse skylights were not conspicuous and/or were not identifiable, confirming forensic analysis. These results suggest that assessment of hazard identification using a quick hazard detection technique may be valid and efficient across variations in incident characteristics.

We describe a case study of a civil suit involving an elevator incident causing serious injury to a 5-year-old male. We illustrate how scientific principles and measurements of conspicuity, cognitive development and parental supervision inform a human factors analysis of the contributing issues of an unusual incident sequence.

This study assesses students’ non-medical use of prescription drugs (NMUPD) from college entrance to graduation, and examines factors that predict NMUPD. Participants: The study was conducted betwe...

BACKGROUND: The American Diabetes Association recommends a family-centered approach that addresses each family’s specific type 1 diabetes self-management barriers. OBJECTIVE: To assess an intervention that tailored delivery of self-management resources to families’ specific self-management barriers. SUBJECTS: At two sites, 214 children 8–16 years old with type 1 diabetes and their parent(s) were randomized to receive tailored self-management resources (intervention, n=106) or usual care (n=108). METHODS: Our intervention 1) identified families’ self-management barriers with a validated survey, 2) tailored self-management resources to identified barriers, and 3) delivered the resources as four group sessions coordinated with diabetes visits. Mixed effects models with repeated measures were fit to A1c as well as parent and child QOL during the intervention and one year thereafter. RESULTS: Participants were 44% youth (8–12 years) and 56% teens (13–16 years). No intervention effect on A1c or QOL was shown, combining data from sites and age groups. Analyzing results by site and age group, post-intervention A1c for teens at one site declined by 0.06 more per month for intervention teens compared to usual care (p8.5 (−0.08, p10 (−0.19, p

BACKGROUND: Alcohol cues on social media may influence young adults’ drinking patterns, these cues may be pro-social or pro-alcohol in nature. The influence of individual Facebook cues on young adults’ drinking intentions and behaviors remains unknown. OBJECTIVES: The purpose of this study was to assess how Facebook cues influence intention to drink, and how intention was associated with Theory of Reasoned Action (TRA) constructs including alcohol-related attitudes and norms, and future behavior. METHODS: Incoming university students completed a pre-college and a 2-year follow-up phone interview. A vignette presented individual Facebook cues representing “pro-social” or “pro-alcohol” sentiments. Participants indicated intention to drink alcohol and their rationale for this intention after each cue. Additional measures included TRA constructs of alcohol-related attitudes and norms, and problem alcohol use. Analyses included a qualitative approach to examine rationales for intention to drink in response to Facebook cues, and linear mixed effects models. RESULTS: Of 338 participants, 56.1% were female, 74.8% were Caucasian. Alcohol-related attitudes and norms were positively associated with intention to drink in response to pro-social and pro-alcohol Facebook cues. Participants’ intention to drink in response to pro-alcohol cues was positively associated with problem alcohol use two years later. CONCLUSIONS/IMPORTANCE: Findings illuminate the influence of social media on alcohol-related behaviors and highlight potential future screening approaches.

OBJECTIVES: To identify pediatric patient-reported outcomes (PROs) that are associated with chronic conditions and to evaluate the effects of chronic disease activity on PROs. STUDY DESIGN: Participants 8–24 years-old and their parents were enrolled into 14 studies that evaluated PROMIS® PROs across 10 chronic conditions--asthma, atopic dermatitis, cancer, cancer survivors, chronic kidney disease, Crohn’s disease, juvenile idiopathic arthritis, lupus, sickle cell disease, and type 1 diabetes mellitus. PRO scores were contrasted with the United States general population of children using nationally representative percentiles. PRO-specific coefficients of variation were computed to illustrate the degree of variation in scores within versus between conditions. Condition-specific measures of disease severity and Cohens d effect sizes were used to examine PRO scores by disease activity. RESULTS: Participants included 2,975 child respondents and 2,392 parent respondents who provided data for 3,409 unique children: 52% were 5–12 years-old, 52% female, 25% African-American/Black, and 14% Hispanic. Across all 10 chronic conditions, children reported more anxiety, fatigue, pain, and mobility restrictions than the general pediatric population. Variation in PRO scores within chronic disease cohorts was equivalent to variation within the general population, exceeding between-cohort variation by factors of 1.9 (mobility) to 5.7 (anxiety). Disease activity was consistently associated with poorer self-reported health, and these effects were weakest for peer relationships. CONCLUSIONS: Chronic conditions are associated with symptoms and functional status in children and adolescents across 10 different disorders. These findings highlight the need to complement conventional clinical evaluations with those obtained directly from patients themselves using PROs.

The transition from &beta, cell compensation to &beta, cell failure is not well understood. Previous works by our group and others have demonstrated a role for Prostaglandin EP3 receptor (EP3), encoded by the Ptger3 gene, in the loss of functional &beta, cell mass in Type 2 diabetes (T2D). The primary endogenous EP3 ligand is the arachidonic acid metabolite prostaglandin E2 (PGE2). Expression of the pancreatic islet EP3 and PGE2 synthetic enzymes and/or PGE2 excretion itself have all been shown to be upregulated in primary mouse and human islets isolated from animals or human organ donors with established T2D compared to nondiabetic controls. In this study, we took advantage of a rare and fleeting phenotype in which a subset of Black and Tan BRachyury (BTBR) mice homozygous for the Leptinob/ob mutation&mdash, a strong genetic model of T2D&mdash, were entirely protected from fasting hyperglycemia even with equal obesity and insulin resistance as their hyperglycemic littermates. Utilizing this model, we found numerous alterations in full-body metabolic parameters in T2D-protected mice (e.g., gut microbiome composition, circulating pancreatic and incretin hormones, and markers of systemic inflammation) that correlate with improvements in EP3-mediated &beta, cell dysfunction.

Objective To identify challenges to the use of Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures in the ambulatory pediatric setting and possible solutions to these challenges. Study design Eighteen semistructured telephone interviews of health system leaders, measurement implementers, and ambulatory pediatric clinicians were conducted. Five coders used applied thematic analysis to iteratively identify and refine themes in interview data. Results Most interviewees had roles in leadership or the implementation of patient-centered outcomes; 39% were clinicians. Some had experience using PROMIS clinically (44%) and 6% were considering this use. Analyses yielded 6 themes: (1) selection of PROMIS measures, (2) method of administration, (3) use of PROMIS Parent Proxy measures, (4) privacy and confidentiality of PROMIS responses, (5) interpretation of PROMIS scores, and (6) using PROMIS scores clinically. Within the themes, interviewees illuminated specific unique considerations for using PROMIS with children, including care transitions and privacy. Conclusions Real-world challenges continue to hamper PROMIS use. Ongoing efforts to disseminate information about the integration of PROMIS measures in clinical care is critical to impacting the health of children.

Sinusoidal obstruction syndrome (SOS) is a serious complication of hematopoietic stem cell transplantation (HSCT). Sirolimus plus tacrolimus is an accepted regimen for graft-versus-host disease (GVHD) prophylaxis, with both agents implicated as risk factors for SOS. We analyzed 260 consecutive patients who underwent allogeneic HSCT following myeloablative conditioning using total body irradiation (TBI)-based (n = 151) or chemotherapy only (n = 109) regimens, with sirolimus plus tacrolimus for GVHD prophylaxis. SOS occurred in 28 patients at a median of 22 (range, 12-58) days. Mean sirolimus trough levels were higher between days 11 and 20 following transplant in patients who developed SOS (10.3 vs. 8.5 ng/ml, P = 0.008), with no significant difference in mean trough levels between days 0 and 10 (P = 0.67) and days 21-30 (P = 0.37). No differences in mean tacrolimus trough levels during the same time intervals were observed between those developing SOS and others. On multivariable analysis, a mean sirolimus trough level ≥ 9 ng/ml between days 11 and 20 increased the risk of SOS (hazard ratio 3.68, 95% CI: 1.57-8.67, P = 0.003), together with a longer time from diagnosis to transplant (P = 0.004) and use of TBI (P = 0.006). Our results suggest that mean trough sirolimus levels ≥ 9 ng/mL between days 11 and 20 post transplant may increase the risk of SOS and should be avoided.

IntroductionTo optimize type 1 diabetes mellitus self-management, experts recommend a person-centered approach, in which care is tailored to meet people’s needs and preferences. Existing tools for tailoring type 1 diabetes mellitus education and support are limited by narrow focus, lack of strong association with meaningful outcomes like A1c, or having been developed before widespread use of modern diabetes technology. To facilitate comprehensive, effective tailoring for today’s working-aged adults with type 1 diabetes mellitus, we developed and validated the Barriers and Supports Evaluation (BASES).Research design and methodsParticipants 25–64 years of age with type 1 diabetes mellitus were recruited from clinics and a population-based registry. Content analysis of semistructured interviews (n=33) yielded a pool of 136 items, further refined to 70 candidate items on a 5-point Likert scale through cognitive interviewing and piloting. To develop and validate the tool, factor analyses were applied to responses to candidate items (n=392). Additional survey data included demographics and the Diabetes-Specific Quality of Life (QOL) Scale-Revised. To evaluate concurrent validity, hemoglobin A1c (HbA1c) values and QOL scores were regressed on domain scores.ResultsFactor analyses yielded 5 domains encompassing 30 items: Learning Opportunities, Costs and Insurance, Family and Friends, Coping and Behavioral Skills, and Diabetes Provider Interactions. Models exhibited good to adequate fit (Comparative Fit Index >0.88 and Root Mean Squared Error of Approximation ConclusionsThe BASES is a valid, comprehensive, person-centered tool that can tailor diabetes support and education to individuals’ needs in a modern practice environment, improving effectiveness and uptake of services. Clinicians could use the tool to uncover patient-specific barriers that limit success in achieving HbA1c goals and optimal QOL.

Background Families play a critical role in supporting the health and well-being of children with chronic illnesses, who face a lifetime of responsibility for self-management of their condition. Our goal was to investigate whether the novel Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric Family Relationships measure, developed primarily within the general pediatric population, reflects the experiences of family relationships for chronically ill children and their parents. Methods We conducted semi-structured qualitative interviews with children (aged 8–17) with common chronic conditions: asthma (n = 6), type 1 diabetes (n = 5), or sickle cell disease (n = 5), and separately with one of their parents (n = 16). Interviews were recorded, and two team members independently coded the written transcripts facilitated by Nvivo 10. The systematic content analysis used a combination of: 1) pre-specified themes corresponding to the six facets of the domain identified during measure development and reflected in the content of the items (i.e., Sense of Family; Love and Caring; Value and Acceptance; Trust, Dependability, and Support; Communication; Enjoyment), as well as 2) open-coding, allowing participants to define important concepts (i.e., disease impact). Results Family relationships were conceptualized in a similar way to the general population, as evidenced by child and parent responses to open-ended questions about family relationships and to specific probes that corresponded with the item content in the Family Relationship 8-item short form. Children spontaneously discussed the impact of their disease on family relationships less often than parents did. Although participants described how living with a chronic illness positively and negatively impacted aspects of family relationships, nearly all participants believed their responses to the PROMIS® Family Relationships items would not change if they (or their child) did not have a chronic illness. Conclusions Among a sample of families of children with one of 3 chronic illnesses, participants described family relationships in a way that was consistent with the facets of the PROMIS® Family Relationship domain. This study adds to the content validity of the measure for children with chronic illness.

This article describes the methodology, recruitment, participant characteristics, and sustained, intensive stakeholder engagement for Project ACE (Achieving control, Connecting resources, Empowering families). Project ACE is a randomized controlled trial of children and youth ages 8-16 with type 1 diabetes evaluating the impact of tailored self-management resources on hemoglobin A1c (A1c) and quality of life (QOL). Despite strong evidence that controlling A1c reduces long-term complications,25% of US youth with type 1 diabetes meet A1c targets. Many interventions are efficacious in improving A1c and QOL for these youth, whose families often struggle with the substantial demands of the treatment regimen. However, most such interventions are ineffective in the real world due to lack of uptake by families and limited healthcare system resources. Project ACE is a multi-site trial designed to improve diabetes outcomes by tailoring existing, evidence-based interventions to meet families' needs and preferences. We hypothesize that this family-centered approach will result in better A1c and QOL than usual care. Project ACE has recruited and randomized 214 eligible 8-16year old youth and their parents. The 9-month intervention consisted of 4 group sessions tailored to families' self-management barriers as identified by a validated instrument. Outcomes including A1c and QOL for parents and youth will be assessed for 1year after the intervention. Stakeholder engagement was used to enhance this trial's recruitment, retention and integration into routine clinical care. Findings will inform implementation and dissemination of family-centered approaches to address self-management barriers.NCT02024750 Trial Registrar: Clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT02024750.

Families play a key role in managing pediatric chronic illness. The PROMIS® pediatric family relationships measure was developed primarily within the general pediatric population. We evaluated the Family Relationships short form in the context of pediatric chronic diseases. Children aged 8–17 years with asthma (n = 73), type 1 diabetes (n = 122), or sickle cell disease (n = 80) completed the Family Relationships 8a short form and the PROMIS Pediatric Profile-25′s six domains representing physical, mental, and social health. Parents (N = 275) of these children completed the parent versions of the same measures. We evaluated reliability of the Family Relationships measure using Cronbach’s alpha and IRT-based marginal reliability, and the standard error of measurement (SEM). Convergent/discriminant validity were assessed from correlations between the Family Relationships domain and the PROMIS-25 domains. SEM increased for scores above the normative mean of 50. Cronbach’s alpha and IRT-estimated marginal reliabilities exceeded 0.80 for children and parents across diseases, except in asthma, where marginal reliability was 0.75 for parents. Scores displayed small to large correlations in the expected directions with social and mental health domains. The largest correlations occurred with parents’ proxy reports of children’s depressive symptoms in sickle cell disease and asthma, r = − 0.60 (95% CI − 0.74, − 0.48) and r = − 0.58 (95% CI − 0.68, − 0.48) respectively. The Family Relationships 8-item short form demonstrated adequate reliability and convergent/discriminant validity for use in pediatric chronic conditions, though scores above the mean displayed greater uncertainty. Evidence of the measure’s reliability and validity in multiple contexts furthers the case for its use.

ObjectivesTo determine whether sharing of routinely collected health service performance data could have predicted a critical safety failure at an Australian maternity service.DesignObservational quantitative descriptive study.SettingA public hospital maternity service in Victoria, Australia.Data sourcesA public health service; the Victorian state health quality and safety office—Safer Care Victoria; the Health Complaints Commission; Victorian Managed Insurance Authority; Consultative Council on Obstetric and Paediatric Mortality and Morbidity; Paediatric Infant Perinatal Emergency Retrieval; Australian Health Practitioner Regulation Agency.Main outcome measuresNumbers and rates for events (activity, deaths, complaints, litigation, practitioner notifications). Correlation coefficients.ResultsBetween 2000 and 2014 annual birth numbers at the index hospital more than doubled with no change in bed capacity, to be significantly busier than similar services as determined using an independent samples t-test (pr2=0.18, p=0.003). Independent samples t-tests demonstrated that the rates of emergency neonatal and perinatal transfer were both significantly lower than similar services (both pConclusionWhile clinical activity data and direct-to-service patient complaints appear to offer promise as potential predictors of health service stress, complaints to regulators and medicolegal activity are less promising as predictors of system failure. Significant changes to how all data are handled would be required to progress such an approach to predicting health service failure.

Introduction Checklists are used to operationalize care processes and enhance patient safety; however, checklist implementation is difficult within complex health systems. A family-centered rounds (FCR) checklist increased physician performance of key rounding activities, which were associated with improved parent engagement, safety perceptions, and behaviors. To inform FCR checklist implementation and dissemination, we assessed physician compliance with this checklist and factors influencing its use. Methods Guided by a recognized human factors and systems engineering approach, rounding observations and ad hoc resident and attending physician interviews were conducted at a tertiary children's hospital. Rounding observers documented 8-item checklist completion (nurse presence, family preference, introductions, assessment/plan, discharge goals, care team questions, family questions, and read back orders) and then interviewed physicians to elicit their perceptions of challenges and facilitators to FCR checklist use. We performed a directed content analysis of interview notes, iteratively categorizing data into known hospital work system components. Results Of 88 individual patient rounds observed after checklist implementation, 90% included the nurse, and 77% occurred at the bedside. In an average patient rounding session, staff performed 82% of checklist items. Factors influencing checklist use were related to all hospital work system components, eg, physician familiarity with checklist content (people), visibility of the checklist (environment), providing schedules for rounding participants (organization), and availability of a mobile computer during rounds (technology). Conclusions Multiple factors within hospital systems may influence FCR checklist use. Strategies, such as providing rounding schedules and mobile computers, may promote optimal engagement of families during rounds and promote pediatric patient safety.

Objective Perinatal depression is a common and costly health concern with serious implications for the mother and child. We sought to quantify the "Perinatal Depression Treatment Cascade"-the cumulative shortfalls in clinical recognition, initiation of treatment, adequacy of treatment, and treatment response for women with antenatal (AND) and postpartum depression (PPD). Data sources A systematic search was conducted to identify articles about diagnostic rates, treatment rates, adequate treatment rates, and remission rates for AND and PPD. We searched PubMed and EMBASE through March 2015. Study selection Articles were included if they were in English and examined rates of detection, treatment, adequate treatment, or remission for AND or PPD. Data extraction and analysis Mean rates of diagnosis, treatment, adequate treatment, and remission were calculated and weighted based on the number of subjects in each study. Search results were dually reviewed for confirmation of study eligibility and data abstraction. Results Decrements occur at each branch of the cascade. Data suggest that 49.9% of women with AND and 30.8% of women with PPD are identified in clinical settings; 13.6% of women with AND and 15.8% of women with PPD receive treatment; 8.6% of women with AND and 6.3% of women with PPD receive adequate treatment; and 4.8% of women with AND and 3.2% of women with PPD achieve remission. Conclusions Application of the treatment cascade model suggests multiple opportunities for improving perinatal depression management, informing optimal allocation of resources, and providing adequate treatment to this underrecognized and undertreated population..

Adults with sickle cell disease (SCD) report problems in relationship building and information exchange during clinic visits. To explore the origin of these communication challenges, we compare communication in pediatric SCD, diabetes, and asthma visits. We collected visit videos and parent surveys from 78 children ages 9–16 years with SCD, asthma, or diabetes. Coders assessed child, parent, and physician utterances reflecting relationship building, information giving, and information gathering. Associations of engagement with type of chronic disease visit were performed with negative binomial regression. Compared to SCD visits, children in diabetes visits spoke 53% more relationship-building utterances (p < .05) and physicians in asthma visits spoke 48% fewer relationship building utterances to the child (p < .01). In diabetes visits, physicians gave almost twice as much information to children and gave 48% less information to parents (both p < .01) compared to SCD visits. Compared to SCD visits, physicians spoke fewer information-gathering utterances to parents in diabetes and asthma visits (85% and 72% respectively, both p < .001). SCD visits reflect less engagement of the children and greater physician effort to gather information from parents. These differences highlight opportunities to enhance engagement as a mechanism for ultimately improving SCD care.

AIMS. Identify the prevalence of health psychology use in children with type 1 diabetes (T1D) and evaluate how individual and contextual characteristics are associated with use. METHODS. Children ages 8 to 16 years with T1D and their parents were recruited from two tertiary diabetes clinics. Cross-sectional data included parent and adolescent surveys and hemoglobin A1c. Parents self-reported the child’s use of health psychology in the last year along with individual factors (e.g., predisposing factors including demographics, enabling factors including health insurance type, evaluated need including mental health diagnoses and perceived need including self-management barriers). Association of health psychology use with individual (e.g., demographics, enabling factors, evaluated and perceived need) and contextual (e.g., clinical site) characteristics was evaluated using logistic regression. RESULTS. Of 363 eligible participants, 267 (74%) participated. Health psychology use was reported by only 8.2% (n=22) of participants and was significantly associated with evaluated need factor of mental health diagnosis (OR 5.8; p

Background: Experts recommend family-centered self-management approaches that address specific T1D self-management barriers for each child and family. However, no system-level method currently exists to identify and address these barriers. Objectives: To assess the impact on glycemic control and QoL for the child and parent of a family-centered approach to the delivery of diabetes self-management resources. Methods: Children 8-16 years old with T1D and their parent(s) were randomized to receive either tailored self-management resources (intervention) or usual care. Our intervention 1) identified families’ self-management barriers with a validated survey, 2) tailored self-management resources to identified barriers, and 3) delivered these resources as group sessions coordinated with diabetes visits to optimize convenience, efficiency, and sustainability. Mixed effects models with repeated measures were used to examine the intervention’s impact on A1c and parent and child QoL during the 9-month intervention period and for a year thereafter. Results: Among 363 potentially eligible families, 267 (74%) consented to participate. Randomization allocated 1families to usual care and 1to the intervention. Participants were children (8-12 years, 44%) and teens (13-16 years, 56%). Mean diabetes duration was 5.4 years (sd 3.3) and 14% had an A1c Conclusions: Findings can inform healthcare organizations’ decisions about ways to best deliver diabetes self-management resources. Disclosure R.V. Fiallo-Scharer: None. V.P. Rajamanickam: None. B.A. Chewning: None. M. Palta: None. T.B. Wetterneck: None. T. Wysocki: None. E.D. Cox: None.

Background Measuring adolescents’ preferences for health states can play an important role in evaluating the delivery of pediatric healthcare. However, formal evaluation of the common direct preference elicitation methods for health states has not been done with adolescents. Therefore, the purpose of this study is to test how these methods perform in terms of their feasibility, reliability, and validity for measuring health state preferences in adolescents. Methods This study used a web-based survey of adolescents, 18 years of age or younger, living in the United States. The survey included four health states, each comprised of six attributes. Preferences for these health states were elicited using the visual analogue scale, time trade-off, and standard gamble. The feasibility, test-retest reliability, and construct validity of each of these preference elicitation methods were tested and compared. Results A total of 144 participants were included in this study. Using a web-based survey format to elicit preferences for health states from adolescents was feasible. A majority of participants completed all three elicitation methods, ranked those methods as being easy, with very few requiring assistance from someone else. However, all three elicitation methods demonstrated weak test-retest reliability, with Kendall’s tau-a values ranging from 0.204 to 0.402. Similarly, all three methods demonstrated poor construct validity, with 9–50% of all rankings aligning with our expectations. There were no significant differences across age groups. Conclusions Using a web-based survey format to elicit preferences for health states from adolescents is feasible. However, the reliability and construct validity of the methods used to elicit these preferences when using this survey format are poor. Further research into the effects of a web-based survey approach to eliciting preferences for health states from adolescents is needed before health services researchers or pediatric clinicians widely employ these methods. Electronic supplementary material The online version of this article (10.1186/s12887-018-1179-7) contains supplementary material, which is available to authorized users.