Parent Engagement in a COVID-19 Cohort Study of Children and Families: Successes, Challenges and Next Steps.

This article describes the methods, successes and challenges of engaging parents while studying the impacts of COVID-19 on healthy children and families. Parent partners in a Parent and Clinician Team (PACT) informed study aims, supported feasibility and recommended changes to enhance participation. PACT members stated that they felt a sense of connectedness and purpose by contributing to COVID-19 research. Engagement increased by parents acquiring new roles, attending more frequent meetings and co-creating alternative methods of engagement. Recruiting new PACT members was challenging, likely due to limited time and resources available to parents of young children during a pandemic.

Family perspectives of COVID-19 research.

BACKGROUND: The COVID-19 pandemic has uniquely affected children and families by disrupting routines, changing relationships and roles, and altering usual child care, school and recreational activities. Understanding the way families experience these changes from parents' perspectives may help to guide research on the effects of COVID-19 among children. MAIN BODY: As a multidisciplinary team of child health researchers, we assembled a group of nine parents to identify concerns, raise questions, and voice perspectives to inform COVID-19 research for children and families. Parents provided a range of insightful perspectives, ideas for research questions, and reflections on their experiences during the pandemic. CONCLUSION: Including parents as partners in early stages of COVID-19 research helped determine priorities, led to more feasible data collection methods, and hopefully has improved the relevance, applicability and value of research findings to parents and children.

Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity.

INTRODUCTION: Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1% or 2%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimises excess adiposity and optimises child nutrition and growth. METHODS AND ANALYSIS: Cow's Milk Fat Obesity pRevention Trial will be a pragmatic, superiority, parallel group randomised controlled trial involving children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids! practice-based research network in Toronto, Canada. Children (n=534) will be randomised to receive one of two interventions: (1) a recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk. The primary outcome is adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness. Outcomes will be measured 24 months postrandomisation and compared using analysis of covariance (ANCOVA), adjusting for baseline measures. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Unity Health Toronto and The Hospital for Sick Children. Results will be presented locally, nationally and internationally and published in a peer-reviewed journal. The findings may be helpful to nutrition guidelines for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention. TRIAL REGISTRATION NUMBER: NCT03914807; pre-results.

Development and content validation of the Muscular Dystrophy Child Health Index of Life with Disabilities questionnaire for children with Duchenne muscular dystrophy.

AIM: To develop a patient-reported outcome measure that comprehensively captures the health-related priorities of children with Duchenne muscular dystrophy (DMD). METHOD: Children with DMD and their parents completed the iteratively revised versions of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), followed by a cognitive interview to develop a pilot version of a new measure. Multidisciplinary health care professionals completed an item-by-item analysis of the measure and a 14-item sensibility questionnaire. Minimum content validity ratio for each item of the new measure and the mean score (0-7) for the items of the sensibility questionnaire were calculated. RESULTS: The CPCHILD underwent changes over 19 interviews with children and their parents, resulting in the pilot Muscular Dystrophy Child Health Index of Life with Disabilities (MDCHILD). The content validity ratio of each MDCHILD item ranged from 0.85 to 1 based on health care professionals' ratings. The mean score exceeded the threshold of four for all items of the sensibility questionnaire. Based on child, parent, and health care professional recommendations, 16 items were added, six eliminated, and 15 items modified from the original CPCHILD. The MDCHILD consists of 47 items over seven domains. INTERPRETATION: The MDCHILD met all sensibility criteria by children with DMD, their parents, and health care professionals, and is ready for psychometric evaluation. WHAT THIS PAPER ADDS: The Muscular Dystrophy Child Health Index of Life with Disabilities (MDCHILD) is a new patient-reported outcome measure for Duchenne muscular dystrophy (DMD). The Priority Framework of Outcomes underpins the content for the MDCHILD. The MDCHILD incorporates the health-related priorities of males with DMD and their parents. The MDCHILD was deemed sensible by children, their parents, and health care professionals.

Safety and Efficacy of Botulinum Toxin A in Children Undergoing Lower Limb Lengthening and Deformity Correction: Results of a Double-blind, Multicenter, Randomized Controlled Trial.

BACKGROUND: Lengthening of the lower limb is a complex procedure in which pain management and complications such as pin-site infections and muscle contractures impact the family and affect the child's quality of life. As a result, the paralytic and antinociceptive actions of neurotoxins may be indicated in managing these complications; however, few studies have explored ways to improve outcomes after lengthenings. The objective of this study was to evaluate the safety and efficacy of botulinum toxin A (BTX-A) in children undergoing lower limb lengthenings and deformity correction. METHODS: Participants with a congenital or acquired deformity of the lower extremity requiring surgery to one limb were randomized to receiving either BTX-A as a single dose of 10 units per kilogram body weight, or an equivalent volume of saline solution. Pain, medication, quality of life, and physical function were assessed at different time-points. Adverse events were recorded in all participants. T test and χ tests were used to compare potential differences across both groups. RESULTS: Mean age of the 125 participants was 12.5 years (range, 5 to 21 y), and lengthenings averaged 4.2 cm. Maximum pain scores on day 1 postoperatively were lower in the BTX-A group (P=0.03) than in the placebo group, and remained significant favoring botox when stratifying by location of lengthening (femur vs. tibia). Clinical benefits for BTX-A were found for 3 quality of life domains at mid-distraction and end-distraction. When stratifying according to location of lengthening, there were significantly fewer pin-site infections in the tibia favoring botox (P=0.03). The amount of adverse events and bone healing indices were no different in both groups. CONCLUSIONS: The clinical differences in quality of life, the lower pain on the first postoperative day, and the lower number of pin-site infections in the tibia favoring BTX-A support its use as an adjunctive treatment to the lengthening process. The detailed analyses of pain patterns help inform families on the pain expectations during lower limb lengthenings. The amount of adverse events were no different in both groups, and bone healing rates were similar, indicating that the use of BTX-A in children undergoing limb lengthening and deformity correction is safe. LEVEL OF EVIDENCE: Level I.

Does hip displacement influence health-related quality of life in children with cerebral palsy?

OBJECTIVE: To evaluate the association of hip lateralisation with health-related quality of life (HRQL) in children with cerebral palsy (CP) using the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD(®)) questionnaire. METHODS: We assessed n = 34 patients (mean age: 10.2 years, SD: 4.7 years; female: n = 16) with bilateral CP and Gross Motor Function Classification System (GMFCS) Level III-V using the CPCHILD(®) questionnaire. Hip lateralisation was measured by Reimer`s migration percentage (MP). RESULTS: There was an association between both, MP and GMFCS with CPCHILD(®) total score. Stratified analyses did not suggest interaction of the association between MP and CPCHILD(®) total score by GMFCS level. After adjustment for GMFCS level, we found a significant linear decrease of CPCHILD(®) total score of -0.188 points by 1% increment in MP. CONCLUSIONS: There was an association between MP and HRQL, which could not be explained by the GMFCS level.

German translation of the caregiver priorities and child health index of life with disabilities questionnaire: test-retest reliability and correlation with gross motor function in children with cerebral palsy.

We aimed to translate the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire into German and to evaluate its reliability and validity by studying the association between CPCHILD scores and gross motor function as measured by the gross motor function classification system (GMFCS) in children with cerebral palsy (CP). The original CPCHILD questionnaire and manual were translated and back translated. It was administered to primary caregivers of persons with CP (GMFCS levels III-V) and was completed a second time 2 weeks after the first to measure test-retest reliability (n = 17). Primary caregivers of 68 children with CP; GMFCS level III (n = 14), level IV (n = 28), and level V (n = 26) completed the questionnaire. Mean total CPCHILD scores across GMFCS levels were 67.1 ± 14.9 for GMFCS level III, 56.6 ± 11.8 for level IV, and 44.3 ± 12.9 for level V. Good correlation (r = - 0.56) was observed between GMFCS and total scores test-retest reliability showed intraclass correlation coefficients between 0.4 and 0.9. The German CPCHILD yielded similar test-retest reliability and score distributions across the GMFCS level as the original version. The best correlations were observed for domains that are close to the functional deficits.

Femoral fractures in adolescents: a comparison of four methods of fixation.

BACKGROUND: The optimal management of femoral fractures in adolescents is controversial. This study was performed to compare the results and complications of four methods of fixation and to determine the factors related to those complications. METHODS: We conducted a retrospective cohort study of 194 diaphyseal femoral fractures in 189 children and adolescents treated with elastic stable intramedullary nail fixation, external fixation, rigid intramedullary nail fixation, or plate fixation. After adjustment for age, weight, energy of the injury, polytrauma, fracture level and pattern, and extent of comminution, treatment outcomes were compared in terms of the length of the hospital stay, time to union, and complication rates, including loss of reduction requiring a reoperation, malunion, nonunion, refracture, infection, and the need for a reoperation other than routine hardware removal. RESULTS: The mean age of the patients was 13.2 years, and their mean weight was 49.5 kg. There was a loss of reduction of two of 105 fractures treated with elastic nail fixation and ten of thirty-three treated with external fixation (p < 0.001). At the time of final follow-up, five patients (two treated with external fixation and one in each of the other groups) had >or=2.0 cm of shortening. Eight of the 104 patients (105 fractures) treated with elastic nail fixation underwent a reoperation (two each because of loss of reduction, refracture, the need for trimming or advancement of the nail, and delayed union or nonunion). Sixteen patients treated with external fixation required a reoperation (ten because of loss of reduction, one for replacement of a pin complicated by infection, one for débridement of the site of a deep infection, three because of refracture, and one for lengthening). One patient treated with a rigid intramedullary nail required débridement at the site of a deep infection, and one underwent removal of a prominent distal interlocking screw. One fracture treated with plate fixation required refixation following refractures. A multivariate analysis with adjustment for baseline differences showed external fixation to be associated with a 12.41-times (95% confidence interval = 2.26 to 68.31) greater risk of loss of reduction and/or malunion than elastic stable intramedullary nail fixation. CONCLUSIONS: External fixation was associated with the highest rate of complications in our series of adolescents treated for a femoral fracture. Although the other three methods yielded comparable outcomes, we cannot currently recommend one method of fixation for all adolescents with a femoral fracture. The choice of fixation will remain influenced by surgeon preference based on expertise and experience, patient and fracture characteristics, and patient and family preferences.

Comparison of surgeon and physiotherapist-directed Ponseti treatment of idiopathic clubfoot.

BACKGROUND: Increasingly, the Ponseti method has been adopted worldwide as the preferred method of managing idiopathic clubfoot deformity. Following the successful implementation of the Ponseti method by orthopaedic surgeons in our institution, a clubfoot clinic was established in 2003. This clinic is directed by a physiotherapist who, using the Ponseti protocol, performs the serial cast treatment and supervises the brace management of all children with idiopathic clubfoot deformity. The purpose of this study was to compare the outcomes of physiotherapist-directed with surgeon-directed Ponseti cast treatment of idiopathic clubfeet. METHODS: We performed a retrospective cohort study of all patients with idiopathic clubfoot deformity treated from 2002 to 2006 and followed for a minimum of two years. Twenty-five children (thirty-four clubfeet) treated by surgeons were compared with ninety-five children (137 clubfeet) treated by a physiotherapist. The outcomes that were evaluated included the number of casts required, the rate of percutaneous Achilles tenotomy, the rate of recurrence, the failure rate, and the need for additional surgical procedures. RESULTS: At the time of presentation, the patients in the two groups were similar in terms of age, sex distribution, laterality of the clubfoot, and history of treatment. The mean duration of follow-up was thirty-four months in the physiotherapist-directed group and forty-eight months in the surgeon-directed group. No significant difference was found between the two groups with regard to the mean number of initial casts, the Achilles tenotomy rate, or the failure rate. Recurrence requiring additional treatment occurred in 14% of the feet in the physiotherapist-directed group and in 26% of the feet in the surgeon-directed group (p = 0.075). Additional procedures, including repeat Achilles tenotomy or a limited posterior or posteromedial release, were required in 6% of the feet in the physiotherapist-directed group and in 18% of those in the surgeon-directed group (p = 0.025). CONCLUSIONS: In our institution, the Ponseti method of cast treatment of idiopathic clubfeet was as effective when it was directed by a physiotherapist as it was when it was directed by a surgeon, with fewer recurrences and a less frequent need for additional procedures in the physiotherapist-directed group. The introduction of the physiotherapist-supervised clubfoot clinic at our institution has been effective without compromising the quality of care of children with clubfoot deformity.

Initial development and validation of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD).

This paper reports the development and validation of a disease-specific measure of health status and well-being of children with severe cerebral palsy (CP). The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) was constructed from recommendations from caregivers, healthcare providers, and review of other measures. Items spanning six domains are rated on an ordinal scale. Standardized scores (0-100) are reported for each domain and in total. Primary caregivers (n = 77) of 45 males and 32 females between 5 and 18 years of age (mean age 13 y 5 mo [SD 3 y 4 mo]) with CP, categorized by the Gross Motor Function Classification System (GMFCS) level, completed the CPCHILD. Caregivers of children with severe CP (GMFCS Levels IV and V) also completed a second administration of the CPCHILD 2 weeks after the first. The mean CPCHILD score for children with severe CP was 56.2 (SD 15.7; range 24-93). The mean CPCHILD scores for children in GMFCS Levels I to V were 22.0, 38.2, 23.0, 44.5, and 59.3 respectively (p < 0.001). Reliability was tested in 41/52 caregivers who reported no change in health status between the two administrations of the CPCHILD. The intraclass correlation coefficient was 0.94 (95% confidence interval 0.90-0.97). The CPCHILD seems to be a reliable and valid measure of caregivers' perspectives on the health status, functional limitations, and well-being of these children.