A phase II dose evaluation pilot feasibility randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

BACKGROUND: Vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (ICU) and associated with worse clinical course. Trials in adult ICU demonstrate rapid restoration of vitamin D status using an enteral loading dose is safe and may improve outcomes. There have been no published trials of rapid normalization of VDD in the pediatric ICU. METHODS: We conducted a multicenter placebo-controlled phase II pilot feasibility randomized clinical trial from 2016 to 2017. We randomized 67 critically ill children with VDD from ICUs in Canada, Chile and Austria using a 2:1 randomization ratio to receive a loading dose of enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or placebo. Participants, care givers, and outcomes assessors were blinded. The primary objective was to determine whether the loading dose normalized vitamin D status (25(OH)D > 75 nmol/L). Secondary objectives were to evaluate for adverse events and assess the feasibility of a phase III trial. RESULTS: Of 67 randomized participants, one was withdrawn and seven received more than one dose of cholecalciferol before the protocol was amended to a single loading dose, leaving 59 participants in the primary analyses (40 treatment, 19 placebo). Thirty-one/38 (81.6%) participants in the treatment arm achieved a plasma 25(OH)D concentration > 75 nmol/L versus 1/18 (5.6%) the placebo arm. The mean 25(OH)D concentration in the treatment arm was 125.9 nmol/L (SD 63.4). There was no evidence of vitamin D toxicity and no major drug or safety protocol violations. The accrual rate was 3.4 patients/month, supporting feasibility of a larger trial. A day 7 blood sample was collected for 84% of patients. A survey administered to 40 participating families showed that health-related quality of life (HRQL) was the most important outcome for families for the main trial (30, 75%). CONCLUSIONS: A single 10,000 IU/kg dose can rapidly and safely normalize plasma 25(OH)D concentrations in critically ill children with VDD, but with significant variability in 25(OH)D concentrations. We established that a phase III multicentre trial is feasible. Using an outcome collected after hospital discharge (HRQL) will require strategies to minimize loss-to-follow-up. CLINICALTRIALS: gov NCT02452762 Registered 25/05/2015.

Do Clinical Data from Transgender Adolescents Support the Phenomenon of "Rapid Onset Gender Dysphoria"?

Although emergence of gender dysphoria at puberty is long established, a distinct pathway of rapid onset gender dysphoria was recently hypothesized based on parental data. Using adolescent clinical data, we tested a series of associations that would be consistent with this pathway, however, our results did not support the rapid onset gender dysphoria hypothesis.

Experiences and Stressors of Parents of Trans and Gender-Diverse Youth in Clinical Care from Trans Youth CAN!

Parents of trans and gender-diverse youth can experience challenges navigating gender-affirming (GA) care such as stigma, transphobia, and lack of support. There is little information available about stressors, worries, and positive feelings of parents as they try to support their youth accessing GA care. This article presents baseline survey data on experiences and stressors of 160 parents/caregivers in the Trans Youth CAN! cohort study, which examined medical, social, and family outcomes in youth age 16 years or younger considering puberty blockers or GA hormones. Data were collected at 10 Canadian gender clinics. Authors report on participating parents' characteristics, levels of support toward youth, stressors, worries, concerns, and positive feelings related to youth's gender. Most parent participants were White (85.1 percent), female (85.1 percent), birth or adoptive parents (96.1 percent), and reported strong support for youth's gender. Participants' concerns included their youth facing rejection (81.9 percent), generalized transphobia (74.6 percent), or encountering violence (76.4 percent). Parents also reported positive feelings about seeing their youth grow more confident. Most parental worries and stressors were situated outside the family, reflecting the systemic discrimination faced by youth and their families. Social workers could address these by developing systems-focused interventions and by further taking into account intersectional health disparities.

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.

OBJECTIVE: To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy. METHODS: A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c. RESULTS: The trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5 ± 3.3(SD) years, T1D duration 3.4 ± 3.1 years, and HbA1c 7.9 ± 0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (P = .007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28-day period, HbA1c was 0.39% (95% CI 0.10%-0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (P < .001). CONCLUSION: CGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c.

Fear of hypoglycemia in children with type 1 diabetes and their parents: Effect of pump therapy and continuous glucose monitoring with option of low glucose suspend in the CGM TIME trial.

To determine if pump therapy with continuous glucose monitoring offering low glucose suspend (LGS) decreases fear of hypoglycemia among children with type 1 diabetes and their parents. The CGM TIME trial is a multicenter randomized controlled trial that enrolled 144 children with type 1 diabetes for at least 1 year (mean duration 3.4 ± 3.1 years) starting pump therapy (MiniMed™ Veo™, Medtronic Canada). CGM (MiniMed™ Enlite™ sensor) offering LGS was introduced simultaneously or delayed for 6 months. Hypoglycemia Fear Scale (HFS) was completed by children ≥10 years old and all parents, at study entry and 12 months later. Simultaneous and Delayed Group participants were combined for all analyses. Subscale scores were compared with paired t-tests, and individual items with paired Wilcoxon tests. Linear regression examined association with CGM adherence. 121/140 parents and 91/99 children ≥10 years had complete data. Mean Behavior subscale score decreased from 21.1 (SD 5.9) to 17.2 (SD 6.1) (p < .001) for children, and 20.7 (SD 7.5) to 17.4 (7.4) (p < .001) for parents. Mean Worry subscale score decreased from 17.9 (SD 11.9) to 11.9 (SD 11.4) (p < .001) for children, and 23.1 (SD 13.2) to 17.6 (SD 10.4) (p < .001) for parents. Median scores for 10/25 child items and 12/25 parent items were significantly lower at 12 months (p < .001). Linear regression found no association between HFS scores and CGM adherence. Insulin pump therapy with CGM offering LGS significantly reduced fear of hypoglycemia not related to CGM adherence in children with type 1 diabetes and their parents.

Gender diversity training in Canadian paediatric postgraduate medical education: A needs assessment survey.

OBJECTIVES: Evaluate the current state of postgraduate medical education on gender diversity in Canadian paediatric residency programs, exploring both resident and program director perceptions. BACKGROUND: Primary care providers are seeing more gender diverse children and youth in their offices, along with an exponential growth in referrals to Canadian specialty clinics and potential for significant mental health comorbidities. Gender-affirming support and management have been shown to improve overall outcomes. There is no mandatory curriculum on gender diversity for Canadian paediatric residency programs. METHODS: Cross-sectional online surveys in English and French distributed to program directors (PDs) and paediatric residents in the 17 Canadian paediatric residency programs. Data were analyzed by descriptive statistics with 95% confidence intervals. RESULTS: Response rate was 88.2% from PDs and 24.5% from paediatric residents. Among PDs, 14.3% (95% confidence interval [CI]: 6.3, 22.3) reported a formal curriculum for gender diversity teaching. Sixty-four per cent (53.3, 75.2) of PDs estimated their residents received ≤ 2 hours teaching on gender diversity. Residents reported comfort levels ≤ 50% on specific topics. Among residents, 73.8% (67.9, 79.6) reported that mandatory time in a gender diversity clinic would be the most effective teaching tool while PDs favoured an online module (66.7% [58.2, 75.1]). Barriers to more teaching included lack of time in a busy curriculum. Over 90% of resident indicated that more teaching on gender diversity is required. CONCLUSIONS: Significant variability in education on gender diversity is seen amongst Canadian paediatric residency programs. Discussion regarding a formal paediatric curriculum on gender diversity is needed.

Decision coaching using a patient decision aid for youth and parents considering insulin delivery methods for type 1 diabetes: a pre/post study.

BACKGROUND: Choice of insulin delivery for type 1 diabetes can be difficult for many parents and children. We evaluated decision coaching using a patient decision aid for helping youth with type 1 diabetes and parents decide about insulin delivery method. METHODS: A pre/post design. Youth and parent(s) attending a pediatric diabetes clinic in a tertiary care centre were referred to the intervention by their pediatric endocrinologist or diabetes physician between September 2013 and May 2015. A decision coach guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. Primary outcomes were youth and parent scores on the low literary version of the validated Decisional Conflict Scale (DCS). RESULTS: Forty-five youth (mean age = 12.5 ± 2.9 years) and 66 parents (45.8 ± 5.6 years) participated. From pre- to post-intervention, youth and parent decisional conflict decreased significantly (youth mean DCS score was 32.0 vs 6.6, p < 0.0001; parent 37.6 vs 3.5, p < 0.0001). Youth's and parents' mean decisional conflict scores were also significantly improved for DCS subscales (informed, values clarity, support, and certainty). 92% of youth and 94% of parents were satisfied with the decision coaching and patient decision aid. Coaching sessions averaged 55 min. Parents (90%) reported that the session was the right length of time; some youth (16%) reported that it was too long. CONCLUSION: Decision coaching with a patient decision aid reduced decisional conflict for youth and parents facing a decision about insulin delivery method.

The experiences of gender diverse and trans children and youth considering and initiating medical interventions in Canadian gender-affirming speciality clinics.

Background: Canadian specialty clinics offering gender-affirming care to trans and gender diverse children and youth have observed a significant increase in referrals in recent years, but there is a lack of information about the experiences of young people receiving care. Furthermore, treatment protocols governing access to gender-affirming medical interventions remain a topic of debate. Aims: This qualitative research aims to develop a deeper understanding of experiences of trans youth seeking and receiving gender-affirming care at Canadian specialty clinics, including their goals in accessing care, feelings about care and medical interventions they have undergone, and whether they have any regrets about these interventions. Methods: The study uses an adapted Grounded Theory methodology from social determinants of health perspective. Thirty-five trans and gender diverse young people aged 9 to 17 years were recruited to participate in semi-structured interviews through the specialty clinics where they had received or were waiting for gender-affirming medical interventions such as puberty blockers, hormone therapy, and surgery. Results: Young people felt positively overall about the care they had received and the medical interventions they had undergone, with many recounting an improvement in their well-being since starting care. Most commonly shared frustrations concerned delays in accessing interventions due to clinic waiting lists or treatment protocols. Some youth described unwanted medication side-effects and others said they had questioned their transition trajectory at certain moments in the past, but none regretted their choice to undergo the interventions. Discussion : The results suggest that trans youth and gender diverse children are benefiting from medical gender-affirming care they receive at specialty clinics, providing valuable insight into their decision-making processes in seeking care and specific interventions. Providers might consider adjusting aspects of treatment protocols (such as age restrictions, puberty stage, or mental health assessments) or applying them on a more flexible, case-by-case basis to reduce barriers to access.

Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial.

Importance: Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. Objective: To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. Design, Setting, and Participants: An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. Interventions: The participants received either a casein hydrolysate or a conventional adapted cow's milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. Main Outcomes and Measures: Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). Results: Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8% [95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). Conclusions and Relevance: Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes. Trial Registration: clinicaltrials.gov Identifier: NCT00179777.

Iron Status at Age 6 Months in Colombian Infants Exclusively Breast-fed for 4 to 5 Versus 6 Months.

OBJECTIVES: The optimal age for introducing complementary feeding to breast-fed infants may differ depending on the setting. Prolonged exclusive breast-feeding (EBF) protects against infection but may increase the risk of iron deficiency (ID)/anaemia (IDA) in vulnerable infants. The aim of the present study was to compare haemoglobin (Hb), serum ferritin (SF), anaemia (Hb < 11 g/L), ID (SF < 12 µg/L) and IDA (Hb < 10.5 g/dL + Hct < 33% + ID) using observational analyses in 6-month old infants from Bogota, Colombia who were EBF for 4 to 5 versus 6 months or older, and examine predictors. METHODS: Infant feeding was recorded, anthropometry performed, and blood obtained for Hb and SF at 6 months in healthy term infants (birth weight > 2500 g), all EBF for ≥4 months. RESULTS: One hundred eight infants (54% boys) were recruited; 46% EBF for 4 to 5 months, 54% EBF at 6 months. Prevalence of anaemia, ID, and IDA was 20%, 10%, and 5%, with no significant difference between EBF4-5 and EBF6 groups. In multivariate models, anaemia/ID were predicted by greater weight gain from 0 to 6 months, and anaemia also by caesarean delivery; Hb was lower in infants with higher intake of cows' milk; SF was lower in boys and those with greater weight gain. EBF4-5 versus EBF6 was not a significant predictor of any outcome. CONCLUSIONS: Anaemia and ID were common at 6 months but were not affected by EBF for 4 to 5 versus 6 months, suggesting 6 months EBF is safe in this population. Further research is, however, required to examine effects on later iron status. The findings highlight the need to emphasise avoidance of cow's milk before 12 months.

Comparison of Consent Models in a Randomized Trial of Corticosteroids in Pediatric Septic Shock.

OBJECTIVES: To describe the use of deferred and prior informed consent models in the context of a low additional risk to standard of care, placebo-controlled randomized controlled trial of corticosteroids in pediatric septic shock. DESIGN: An observational substudy of consent processes in a randomized controlled trial of hydrocortisone versus placebo. SETTING: Seven tertiary level PICUs in Canada. PATIENTS: Children newborn to 17 years inclusive admitted to PICU with suspected septic shock between July 2014 and March 2016. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Information on the number of families approached, consent rates obtained, and spontaneously volunteered reasons for nonparticipation were collected for both deferred and informed consent. The research ethics board of five of seven centers approved a deferred consent model; however, implementation criteria for use of this model varied across sites. The consent rate using deferred versus prior informed consent was significantly higher (83%; 35/42 vs 58%; 15/26; p = 0.02). The mean times from meeting inclusion criteria to randomization (1.8 ± 1.8 vs 3.6 ± 2.1 hr; p = 0.007) and study drug administration (3.4 ± 2.7 hr vs 4.8 ± 2.1 hr; p = 0.05) were significantly shorter with the use of deferred consent versus prior informed consent. No family member or research ethics board expressed concern following use of deferred consent. CONCLUSIONS: Deferred consent was acceptable in time-sensitive critical care research to most research ethics boards, families, and healthcare providers and resulted in higher consent rates and more efficient recruitment. Larger studies on deferred consent and consistency interpreting jurisdictional guidelines are needed to advance pediatric acute care.

A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.

OBJECTIVE: To determine the feasibility of conducting a randomized controlled trial of corticosteroids in pediatric septic shock. DESIGN: Randomized, double-blind, placebo controlled trial. SETTING: Seven tertiary level PICUs in Canada. PATIENTS: Children newborn to 17 years old inclusive with suspected septic shock. INTERVENTION: Administration of IV hydrocortisone versus placebo until hemodynamic stability is achieved or for a maximum of 7 days. MEASUREMENTS AND MAIN RESULTS: One hundred seventy-four patients were potentially eligible of whom 101 patients met eligibility criteria. Fifty-seven patients were randomized, and 49 patients (23 and 26 patients in the hydrocortisone and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventilation, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. CONCLUSIONS: This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge.

Parental decision making involvement and decisional conflict: a descriptive study.

BACKGROUND: Decisional conflict is a state of uncertainty about the best treatment option among competing alternatives and is common among adult patients who are inadequately involved in the health decision making process. In pediatrics, research shows that many parents are insufficiently involved in decisions about their child's health. However, little is known about parents' experience of decisional conflict. We explored parents' perceived decision making involvement and its association with parents' decisional conflict. METHOD: We conducted a descriptive survey study in a pediatric tertiary care hospital. Our survey was guided by validated decisional conflict screening items (i.e., the SURE test). We administered the survey to eligible parents after an ambulatory care or emergency department consultation for their child. RESULTS: Four hundred twenty-nine respondents were included in the analysis. Forty-eight percent of parents reported not being offered treatment options and 23% screened positive for decisional conflict. Parents who reported being offered options experienced less decisional conflict than parents who reported not being offered options (5% vs. 42%, p < 0.001). Further, parents with options were more likely to: feel sure about the decision (RR 1.08, 95% CI 1.02-1.15); understand the information (RR 1.92, 95% CI 1.63-2.28); be clear about the risks and benefits (RR 1.12, 95% CI 1.05-1.20); and, have sufficient support and advice to make a choice (RR 1.07, 95% CI 1.03-1.11). CONCLUSION: Many parents in our sample experienced decisional conflict after their clinical consultation. Involving parents in the decision making process might reduce their risk of decisional conflict. Evidence based interventions that support parent decision making involvement, such as shared decision making, should be evaluated and implemented in pediatrics as a strategy to reduce parents' decisional conflict.

Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial.

Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines.

Barriers to and facilitators of implementing shared decision making and decision support in a paediatric hospital: A descriptive study.

OBJECTIVE: To explore multiple stakeholders' perceived barriers to and facilitators of implementing shared decision making and decision support in a tertiary paediatric hospital. METHODS: An interpretive descriptive qualitative study was conducted using focus groups and interviews to examine senior hospital administrators', clinicians', parents' and youths' perceived barriers to and facilitators of shared decision making and decision support implementation. Data were analyzed using inductive thematic analysis. RESULTS: Fifty-seven stakeholders participated. Six barrier and facilitator themes emerged. The main barrier was gaps in stakeholders' knowledge of shared decision making and decision support. Facilitators included compatibility between shared decision making and the hospital's culture and ideal practices, perceptions of positive patient and family outcomes associated with shared decision making, and positive attitudes regarding shared decision making and decision support. However, youth attitudes regarding the necessity and usefulness of a decision support program were a barrier. Two themes were both a barrier and a facilitator. First, stakeholder groups were uncertain which clinical situations are suitable for shared decision making (eg, new diagnoses, chronic illnesses, complex decisions or urgent decisions). Second, the clinical process may be hindered if shared decision making and decision support decrease efficiency and workflow; however, shared decision making may reduce repeat visits and save time over the long term. CONCLUSIONS: Specific knowledge translation strategies that improve shared decision making knowledge and match specific barriers identified by each stakeholder group may be required to promote successful shared decision making and decision support implementation in the authors' paediatric hospital.

OBJECTIF: Explorer les obstacles et les incitations perçus par de multiples intervenants à l'adoption de décisions partagées et d'aides à la décision dans un hôpital pédiatrique de soins tertiaires. MÉTHODOLOGIE: Les chercheurs ont réalisé une étude qualitative et descriptive interprétative au moyen de groupes de travail et d'entrevues pour examiner les obstacles et les incitations que percevaient des hauts dirigeants des hôpitaux, des cliniciens, des parents et des jeunes à l'égard de l'adoption de décisions partagées et d'aides à la décision. Ils ont recouru à l'analyse thématique inductive pour évaluer les données. RÉSULTATS: Cinquante-sept intervenants ont participé et relevé six thèmes liés aux obstacles et aux incitations. Le principal obstacle était les lacunes des intervenants en matière de décisions partagées et d'aides à la décision. Les incitations incluaient la compatibilité entre les décisions partagées et la culture ainsi que les pratiques idéales de l'hôpital, les perceptions de résultats positifs chez les patients et les familles grâce aux décisions partagées, et les attitudes positives envers des décisions partagées et des aides à la décision. Cependant, les attitudes des adolescents quant à la nécessité et à l'utilité d'un programme d'aide à la décision représentaient un obstacle. Deux thèmes constituaient à la fois des obstacles et des incitations. D'abord, les groupes d'intervenants ne savaient pas quelles situations cliniques convenant aux décisions partagées (p. ex., nouveaux diagnostics, maladies chroniques, décisions complexes ou décisions urgentes). Ensuite, le processus clinique peut être entravé si une décision partagée et une aide à la décision réduisent l'efficacité et le déroulement du travail. Cependant, ces décisions partagées peuvent limiter les consultations répétées à l'hôpital et favoriser un gain de temps à long terme. CONCLUSIONS: Des stratégies précises d'application des connaissances pour améliorer le savoir sur les décisions partagées et corriger les obstacles relevés par chaque groupe d'intervenants pourraient s'imposer pour favoriser l'adoption de décisions partagées et d'aides à la décision à l'hôpital pédiatrique des auteurs.

Decision coaching using the Ottawa family decision guide with parents and their children: a field testing study.

BACKGROUND: Although children can benefit from being included in health decisions, little is known about effective interventions to support their involvement. The objective of this study was to evaluate the feasibility and acceptability of decision coaching guided by the Ottawa Family Decision Guide with children and parents considering insulin delivery options for type 1 diabetes (insulin pump, multiple daily injections, or standard insulin injections). METHODS: Pre-/post-test field testing design. Eligible participants were children (≤18 years) with type 1 diabetes and their parents attending an ambulatory diabetes clinic in a tertiary children's hospital. Parent-child dyads received decision coaching using the Ottawa Family Decision Guide that was pre-populated with evidence on insulin delivery options, benefits, and harms. Primary outcomes were feasibility of recruitment and data collection, and parent and child acceptability of the intervention. RESULTS: Of 16 families invited to participate, 12 agreed and 7 attended the decision coaching session. For the five missed families, two families were unable to attend the session or the decision coach was not available (N=3). Baseline and immediately post-coaching questionnaires were all completed and follow-up questionnaires two weeks post-coaching were missing from one parent-child dyad. Missing questionnaire items were 5 of 340 items for children (1.5%) and 1 of 429 for parents (0.2%). Decision coaching was rated as acceptable with higher scores from parents and their children who were in earlier stages of decision making. CONCLUSION: Decision coaching with children and their parents considering insulin options was feasible implement and evaluate in our diabetes clinic and was acceptable to participants. Recruitment was difficult due to scheduling restrictions related to the timing of the study. Coaching should target participants earlier in the decision making process and be scheduled at times that are convenient for families and coaches. Findings were used to inform a full-scale evaluation that is currently underway.

Knowledge, attitudes, and practices related to pet contact by immunocompromised children with cancer and immunocompetent children with diabetes.

OBJECTIVE: To compare knowledge, attitudes, and risks related to pet contact in households with and without immunocompromised children. STUDY DESIGN: A questionnaire was distributed to parents of children diagnosed with cancer (immunocompromised; n=80) or diabetes (immunocompetent; n=251) receiving care at the Children's Hospital of Eastern Ontario. Information was collected on knowledge of pets as sources of disease, concerns regarding pet-derived pathogens, and pet ownership practices. Data were analyzed with multivariable logistic regression. RESULTS: The questionnaire was completed by 65% (214 of 331) of the individuals to whom it was given. Pet ownership was common; 45% of respondents had a household pet when their child was diagnosed, and many (households with a child with diabetes, 49%; households with a child with cancer, 20%) acquired a new pet after diagnosis. Most households that obtained a new pet had acquired a pet considered high risk for infectious disease based on species/age (diabetes, 73%; cancer, 77%). Parents of children with cancer were more likely than parents of children with diabetes to recall being asked by a physician/staff member if they owned a pet (OR, 5.9) or to recall receiving zoonotic disease information (OR, 5.3), yet these interactions were reported uncommonly (diabetes, ≤13%; cancer, ≤48%). Greater knowledge of pet-associated pathogens was associated with recalled receipt of previous education on this topic (OR, 3.9). Pet exposure outside the home was reported frequently for children in non-pet-owning households (diabetes, 48%; cancer, 25%). CONCLUSION: Improved zoonotic disease education is needed for pet-owning and non-pet-owning households with immunocompromised children, with ongoing provision of information while the children are at increased risk of disease. Additional efforts from pediatric and veterinary healthcare professionals are required.

Use of vitamin D supplements during infancy in an international feeding trial.

OBJECTIVE: To examine the use of vitamin D supplements during infancy among the participants in an international infant feeding trial. DESIGN: Longitudinal study. SETTING: Information about vitamin D supplementation was collected through a validated FFQ at the age of 2 weeks and monthly between the ages of 1 month and 6 months. SUBJECTS: Infants (n 2159) with a biological family member affected by type 1 diabetes and with increased human leucocyte antigen-conferred susceptibility to type 1 diabetes from twelve European countries, the USA, Canada and Australia. RESULTS: Daily use of vitamin D supplements was common during the first 6 months of life in Northern and Central Europe (>80% of the infants), with somewhat lower rates observed in Southern Europe (> 60%). In Canada, vitamin D supplementation was more common among exclusively breast-fed than other infants (e.g., 71% v. 44% at 6 months of age). Less than 2% of infants in the U.S.A. and Australia received any vitamin D supplementation. Higher gestational age, older maternal age and longer maternal education were study-wide associated with greater use of vitamin D supplements. CONCLUSIONS: Most of the infants received vitamin D supplements during the first 6 months of life in the European countries, whereas in Canada only half and in the U.S.A. and Australia very few were given supplementation.

Interventions to support children's engagement in health-related decisions: a systematic review.

BACKGROUND: Children often need support in health decision-making. The objective of this study was to review characteristics and effectiveness of interventions that support health decision-making of children. METHODS: A systematic review. Electronic databases (PubMed, the Cochrane Library, Web of Science, Scopus, ProQuest Dissertations and Theses, CINAHL, PsycINFO, MEDLINE, and EMBASE) were searched from inception until March 2012. Two independent reviewers screened eligibility: a) intervention studies; b) involved supporting children (≤18 years) considering health-related decision(s); and c) measured decision quality or decision-making process outcomes. Data extraction and quality appraisal were conducted by one author and verified by another using a standardized data extraction form. Quality appraisal was based on the Cochrane Risk of Bias tool. RESULTS: Of 4313 citations, 5 studies were eligible. Interventions focused on supporting decisions about risk behaviors (n = 3), psycho-educational services (n = 1), and end of life (n = 1). Two of 5 studies had statistically significant findings: i) compared to attention placebo, decision coaching alone increased values congruence between child and parent, and child satisfaction with decision-making process (lower risk of bias); ii) compared to no intervention, a workshop with weekly assignments increased overall decision-making quality (higher risk of bias). CONCLUSIONS: Few studies have focused on interventions to support children's participation in decisions about their health. More research is needed to determine effective methods for supporting children's health decision-making.