Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.

BACKGROUND: Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies. METHODS: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items. RESULTS: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%). CONCLUSIONS: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.

Prevalence of patient partner authorship and acknowledgment in child health research publications: an umbrella review.

OBJECTIVES: Children and families are increasingly involved as equal partners in child health research, however, considerations around authorship have received little attention and there is limited guidance on the topic. Our objective was to determine the frequency and nature of patient partner authorship and/or acknowledgment among articles focused on patient engagement in child health research. STUDY DESIGN AND SETTING: In this umbrella review, we searched MEDLINE, Embase, APA PsycINFO, Cochrane Database of Systematic Reviews, CINAHL, and Web of Science for systematic/scoping reviews on patient engagement in child health research. Individual articles included in eligible reviews comprised the sample of articles for analysis and were examined to identify patient partner authorship. Descriptive statistics were used to quantify patient partner authorship and/or acknowledgment and to summarize article characteristics. RESULTS: Twelve systematic/scoping reviews met eligibility criteria, from which 230 individual articles were examined. In 16/230 (7%) articles, there was at least one patient partner author, and in 6/230 (3%) articles, patient partners were included as group authors. Within article Acknowledgments sections, patient partners were acknowledged by name in 41/230 (18%) articles, and anonymously or as a group in 98/230 (43%) articles. Patient partner authorship and/or acknowledgment was more frequent among articles published more recently (after 2015) and among articles where patient engagement was explicitly reported in the article. CONCLUSION: Patient partners were more likely to be acknowledged than listed as an author on articles on patient engagement in child health research. Understanding patient partner preferences about authorship and acknowledgment, examination of the unique aspects of child and youth authorship and developing supports to empower patient partner authorship are needed.

Youth and family involvement in the development of a plain language trial results communication tool: CommuniKIDS.

BACKGROUND: Pediatric trials are possible through voluntary participation of children, youth (age ≤ 18 years), and their families. Despite important arguments for trialists to provide trial progress or results, and evidence that participants desire it, this information remains rarely shared with youth and their families. Little guidance exists on how trialists can best communicate trial results back to participants and their families. Guided by Liabo et al.'s framework, we describe how we developed a pediatric-specific, "plain language summary" clinical trial results template called CommuniKIDS with an adult patient partner, family partner (parent), youth advisors, and parent advisors, taking into account their unique knowledge needs and preferences. MAIN TEXT: Patient and Public Involvement (PPI) was integrated in the development of the CommuniKIDS template. In collaboration with Clinical Trials Ontario, we used a generic trial results template as a starting point. The core project leadership team included a patient partner and a family partner from project inception to completion. Five youth (ages 13-18 years) and eight parent advisors were consulted at each point of the development process through three virtual workshops conducted separately; youth workshops were led by a youth facilitator. During these workshops, advisors agreed on the importance and value of sharing trial results, and expressed their preferences on content, format, and timing of sharing trial results. PPI-led improvements included the addition of three new sections to the CommuniKIDS template: "at a glance," "side effects," and "next steps." We reflect on our PPI strategy in the context of five "values" and six "practicalities" identified as good PPI principles, and summarize lessons learned when collaborating with youth and families from this project. CONCLUSION: Involvement of a patient partner, a family partner, youth advisors, and parent advisors in the development of CommuniKIDS was critical to create a clinical trial results template that is useful and relevant to its end-users. To our knowledge, CommuniKIDS is the first to meaningfully engage youth and parents as advisors and partners in developing a plain language summary results template for pediatric trial participants and their families. Our experience of co-developing CommuniKIDS demonstrates that meaningful PPI can be achieved in trial results communication and knowledge translation practices. This report provides resources for those seeking to involve youth and families in their initiatives and in meaningfully sharing trial results.

The voluntary participation of youth aged 18 and under in clinical trials makes it possible for researchers and healthcare providers to study medications and other treatments. However, most youth and their families who take part in clinical trials do not get any information on the trial's progress or results, leaving many to wonder if anything useful came from their participation. There is an ethical obligation to give this information back to youth and their families, who might take risks by participating in trials. The aim of the CommuniKIDS project was to develop a "plain language summary" results template to share trial results back to youth and their families. Working with a patient partner, a family partner, five youth advisors (ages 13­18), and eight parent advisors, we set out to understand what youth and parents would like to see in a plain language summary of clinical trial results. The needs and preferences discussed with the advisors were included to create a child/youth health-specific template. The CommuniKIDS project is the first to involve youth and parents as advisors in developing a plain language summary results template for child/youth health trials. Here, we describe how we involved youth and parents in the development of CommuniKIDS, how the template was customized to be youth and family-friendly and reflect on lessons learned.

Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials.

BACKGROUND: There are few data on patient and public involvement (PPI) in pragmatic trials. We aimed to describe the prevalence and nature of PPI within pragmatic trials, describe variation in prevalence of PPI by trial characteristics and compare prevalence of PPI reported by trial authors to that reported in trial publications. METHODS: We applied a search filter to identify pragmatic trials published from 2014 to 2019 in MEDLINE. We invited the corresponding authors of pragmatic trials to participate in an online survey about their specific trial. RESULTS: Of 3163 authors invited, 2585 invitations were delivered, 710 (27.5%) reported on 710 unique trials and completed the survey; 334 (47.0%) conducted PPI. Among those who conducted PPI, for many the aim was to increase the research relevance (86.3%) or quality (76.5%). Most PPI partners were engaged at protocol development stages (79.1%) and contributed to the co-design of interventions (70.9%) or recruitment or retention strategies (60.5%). Patient and public involvement was more common among trials involving children, trials conducted in the United Kingdom, cluster randomized trials, those explicitly labelled as "pragmatic" in the study manuscript, and more recent trials. Less than one-quarter of trials (22.8%) that reported PPI in the survey also reported PPI in the trial manuscript. INTERPRETATION: Nearly half of trialists in this survey reported conducting PPI and listed several benefits of doing so, but researchers who did not conduct PPI often cited a lack of requirement for it. Patient and public involvement appears to be significantly underreported in trial publications. Consistent and standardized reporting is needed to promote transparency about PPI methods, outcomes, challenges and benefits.

A pediatric virtual care evaluation framework and its evolution using consensus methods.

BACKGROUND: The use of virtual care has increased dramatically in response to the COVID-19 pandemic, yet evidence is lacking regarding the impact of virtual care on patient outcomes, particularly in pediatrics. A standardized evaluation approach is required to support the integration of virtual care into pediatric health care delivery programs. The objective of this work was to develop a comprehensive and structured framework for pediatric virtual care evaluation. This framework is intended to engage and guide care providers, health centres, and stakeholders towards the development of a standardized approach to the evaluation of pediatric virtual care. METHODS: We brought together a diverse multidisciplinary team, including pediatric clinicians, researchers, digital health leads and analysts, program leaders, a human factors engineer, a family advisor and our manager of health equity and diversity. The team reviewed the literature, including published evaluation frameworks, and used a consensus-based method to develop a virtual care evaluation framework applicable to a broad spectrum of pediatric virtual care programs. We used an iterative process to develop framework components, including domains and sub-domains, examples of evaluation questions, measures, and data sources. Team members met repeatedly over seven months to generate and provide feedback on all components of the framework, making revision as needed until consensus was reached. The framework was then applied to an existing virtual care program. RESULTS: The resulting framework includes four domains (health outcomes, health delivery, individual experience, and program implementation) and 19 sub-domains designed to support the development and evaluation of pediatric virtual care programs. We also developed guidance on how to use the framework and illustrate its utility by applying it to an existing pediatric virtual care program. CONCLUSIONS: This virtual care evaluation framework expands on previously developed frameworks by providing additional detail and a structure that supports practical application. It can be used to evaluate a wide range of pediatric virtual care programs in a standardized manner. Use of this comprehensive yet easy to use evaluation framework will inform appropriate implementation and integration of virtual care into routine practice and support its sustainability and continuous improvement.

Evaluation Strategies for Understanding Experiences With Virtual Care in Canada: Mixed Methods Study.

BACKGROUND: Virtual care was rapidly integrated into pediatric health services during the COVID-19 pandemic. While virtual care offers many benefits, it is necessary to better understand the experiences of those who receive, deliver, and coordinate virtual care in order to support sustainable, high-quality, and patient-centered health care. To date, methods implemented to evaluate users' experiences of virtual care have been highly variable, making comparison and data synthesis difficult. OBJECTIVE: This study aims to describe evaluation strategies currently used to understand personal experiences with pediatric virtual care in Canada. METHODS: In this mixed methods environmental scan, we first distributed a web-based questionnaire to clinical, research, and operational leaders delivering and evaluating pediatric virtual care in Canada. The questionnaire collected information about how experiences with virtual care have been or are currently being evaluated and whether these evaluations included the perspectives of children or youth, families, providers, or support staff. Second, respondents were asked to share the questions they used in their evaluations, and a content analysis was performed to identify common question categories. Third, we conducted semistructured interviews to further explore our respondents' evaluation experiences across 4 domains-evaluation approaches, distribution methods, response rates, and lessons learned-and interest in a core set of questions for future evaluations. RESULTS: There were 72 respondents to the web-based questionnaire; among those who had conducted an evaluation, we identified 15 unique evaluations, and 14 of those provided a copy of the tools used to evaluate virtual care. These evaluations measured the virtual care experiences of parents or caregivers (n=15, 100%), children or youth (n=11, 73%), health care providers (n=11, 73%), and support staff (n=4, 27%). The most common data collection method used was electronic questionnaires distributed by email. Two respondents used validated tools; the remainder modified existing tools or developed new tools. Content analysis of the 14 submitted questionnaires revealed that the most common questions were about overall participant satisfaction, the comparison of virtual care to in-person care, and whether participants would choose virtual care options in the future. Interview findings indicate respondents frequently relied on methods used by peers and that a standardized, core set of questions to evaluate experiences with virtual care would be helpful to improve evaluation practices and support pediatric health care delivery. CONCLUSIONS: At our institution and elsewhere in Canada, experiences with pediatric virtual care have been evaluated using a variety of methods. A more consistent evaluation approach using standardized tools may enable more regular comparisons of experiences with virtual care and the synthesis of findings across health care settings. In turn, this may better inform our approach to virtual care, improve its integration into health systems, and facilitate sustainable, high-quality, patient-centered care.

Validation of a parent proxy-reported beverage screener compared to a 24-hour dietary recall for the measurement of sugar-containing beverage intake among young children.

Measures that can provide reasonably accurate estimates of sugar-containing beverage (SCB) intake among children are needed. The primary objective of this study was to evaluate the relative validity of a short beverage screener (Nutrition and Health Questionnaire, NHQ) compared to a 24-hour recall (Automated Self-Administered 24-h (ASA24) Dietary Assessment Tool-Canada) for assessing parent proxy-reported daily SCB intake among children aged 4-14 years from the TARGet Kids! research network in Toronto, Canada. Children for whom a NHQ completed between March 2018 and June 2019 and an ASA24 completed within one year were included. A total of 471 parents who completed the NHQ beverage screener were also asked to complete the ASA24. One-hundred sixty-three completed the ASA24 and of this group, 109 were analyzed. Estimates of daily intake of 100% juices, sweetened drinks and soda, and total SCBs from the two measures were compared. The mean difference in beverage intake, Spearman correlations, and Bland-Altman plots were estimated for continuous measures. The kappa coefficient, sensitivity, and specificity were calculated for dichotomous measures of any daily intake versus none. The mean difference in total SCB intake between the NHQ and ASA24 was 0.14 cups/day (95% CI 0.01, 0.29) and the correlation was 0.43 (95% CI 0.26, 0.57). Sensitivity and specificity for any daily SCB intake were 0.63 and 0.76, respectively. Overall, parent proxy-reporting of children's total SCB intake from a beverage screener can provide reasonable estimates of SCB intake when detailed dietary assessment is not feasible.

Ethical and practical considerations related to data sharing when collecting patient-reported outcomes in care-based child health research.

PURPOSE: The collection and use of patient reported outcomes (PROs) in care-based child health research raises challenging ethical and logistical questions. This paper offers an analysis of two questions related to PROs in child health research: (1) Is it ethically obligatory, desirable or preferable to share PRO data collected for research with children, families, and health care providers? And if so, (2) What are the characteristics of a model best suited to guide the collection, monitoring, and sharing of these data? METHODS: A multidisciplinary team of researchers, providers, patient and family partners, and ethicists examined the literature and identified a need for focus on PRO sharing in pediatric care-based research. We constructed and analyzed three models for managing pediatric PRO data in care-based research, drawing on ethical principles, logistics, and opportunities to engage with children and families. RESULTS: We argue that it is preferable to share pediatric PRO data with providers, but to manage expectations and balance the risks and benefits of research, this requires a justifiable data sharing model. We argue that a successful PRO data sharing model will allow children and families to have access to and control over their own PRO data and be engaged in decision-making around how PROs collected for research may be integrated into care, but require support from providers. CONCLUSION: We propose a PRO data sharing model that can be used across diverse research settings and contributes to improved transparency, communication, and patient-centered care and research.

The Impact of Patient and Family Engagement in Child Health Research: A Scoping Review.

OBJECTIVE: To identify impacts of patient and family engagement in child health research on the research process, research teams, and patient and family partners. STUDY DESIGN: A scoping review was conducted using the MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and Web of Science databases. English-language studies were included if they described ≥1 impact of patient and family engagement on child health research (age <18 years), researchers, or patient and family partners. Data were retrieved by 2 independent extractors. RESULTS: Of the 7688 studies identified, 25 were included in our analysis. Impacts of patient and family engagement were mostly on the research process (n = 24 studies; 96%), 11 (44%) determined impacts on the research team, and 17 (68%) reported impacts on patient and family partners. Less than one-half (n = 11; 44%) had a primary purpose of determining the impact of patient engagement, and no study used a specific evaluation tool. CONCLUSIONS: Patient and family engagement can strengthen the relevance and feasibility of research and empower researchers and patient partners. Measuring and reporting the impact of engagement is rare. Systematic and standardized evaluation of engagement is needed to understand how, when, and why to engage patients and families.

Facilitating and supporting the engagement of patients, families and caregivers in research: the "Ottawa model" for patient engagement in research.

BACKGROUND: Patient engagement is increasingly being recognized as a critical component of health research; however, institutional models for building infrastructure and capacity for patient engagement in research are limited. There is an opportunity to create reproducible and scalable models of patient engagement in research and share best and promising practices. MAIN BODY: In this article, we describe the development and features of the framework for the Ottawa Patient Engagement in Research Model at The Ottawa Hospital (TOH) and the Ottawa Hospital Research Institute (OHRI). Key components of the model include: a Patient and Family Engagement Program at TOH, which recruits, educates, and supports patients, families and caregivers to engage in clinical care, governance, and research; the Ottawa Methods Centre within the OHRI, which leads methodological research and provides support to investigators for patient engagement and patient-oriented research at TOH; and the Office of Patient Engagement in Research Activities, also within the OHRI, which facilitates collaborations between patients, researchers, clinicians and other stakeholders. Early success of this model can be attributed to aligned institutional priorities between TOH, OHRI and patients, the establishment of a patient engagement policy, ongoing education and support provided to patient partners and researchers, and innovative recruitment, tracking and evaluation procedures. Ongoing challenges and next steps include promoting diversity among patient partners, implementing an equitable compensation policy, engaging patients across a variety of roles and research areas, and developing resources to expand and sustain this program. CONCLUSION: This model represents a unique effort of patients, clinicians, researchers, and policymakers across disciplines and institutions to produce a harmonized strategy and infrastructure for meaningful collaboration with patients and families in health research, and capacity building in patient-oriented research.

Involving patients and families as partners in planning, conducting, and sharing results of health research, referred to as patient engagement, is becoming more common and recognized as important part of the research process. However, guidelines and examples of how to do this well are limited. In this article, we describe the development and features of the Ottawa Patient Engagement in Research Model at The Ottawa Hospital (TOH) and the Ottawa Hospital Research Institute (OHRI). Key pieces of the model include: a Patient and Family Engagement Program, which recruits, educates, and supports patients and families to engage in clinical care, decision making, and research; the Ottawa Methods Centre, which leads studies to understand the best methods to conduct research, and provides support to researchers for patient engagement; and the Office of Patient Engagement in Research Activities, which connects patients, researchers, clinicians, and other stakeholders. Early success of this model may be a result of shared priorities between TOH, OHRI and patients, the creation of a patient engagement policy, ongoing support provided to patients, family members and researchers, and creative methods for recruitment, tracking and evaluation procedures. Ongoing challenges and next steps include promoting diversity among patient partners, setting up a fair and transparent policy for compensating patient partners, and engaging patients across a variety of roles and research areas.This model represents a unique effort of patients, clinicians, researchers, and policymakers across disciplines and institutions to produce one strategy for meaningful teamwork with patients and families in health research.

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.

Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov: A cross-sectional analysis.

BACKGROUND: Use of patient-reported outcomes (PROs) and patient and public engagement are critical ingredients of pragmatic trials, which are intended to be patient centered. Engagement of patients and members of the public in selecting the primary trial outcome and determining the target difference can better ensure that the trial is designed to inform the decisions of those who ultimately stand to benefit. However, to the best of our knowledge, the use and reporting of PROs and patient and public engagement in pragmatic trials have not been described. The objectives of this study were to review a sample of pragmatic trials to describe (1) the prevalence of reporting patient and public engagement; (2) the prevalence and types of PROs used; (3) how its use varies across trial characteristics; and (4) how sample sizes and target differences are determined for trials with primary PROs. METHODS AND FINDINGS: This was a methodological review of primary reports of pragmatic trials. We used a published electronic search filter in MEDLINE to identify pragmatic trials, published in English between January 1, 2014 and April 3, 2019; we identified the subset that were registered in ClinicalTrials.gov and explicitly labeled as pragmatic. Trial descriptors were downloaded from ClinicalTrials.gov; information about PROs and sample size calculations were extracted from the manuscript. Chi-squared, Cochran-Armitage, and Wilcoxon rank sum tests were used to examine associations between trial characteristics and use of PROs. Among 4,337 identified primary trial reports, 1,988 were registered in CT.gov, of which 415 were explicitly labeled as pragmatic. Use of patient and public engagement was identified in 39 (9.4%). PROs were measured in 235 (56.6%): 144 (34.7%) used PROs as primary outcomes and 91 (21.9%) as only secondary outcomes. Primary PROs were symptoms (64; 44%), health behaviors (36; 25.0%), quality of life (17; 11.8%), functional status (16; 11.1%), and patient experience (10; 6.9%). Trial characteristics with lower prevalence of use of PROs included being conducted exclusively in children or adults over age 65 years, cluster randomization, recruitment in low- and middle-income countries, and primary purpose of prevention; trials conducted in Europe had the highest prevalence of PROs. For the 144 trials with a primary PRO, 117 (81.3%) reported a sample size calculation for that outcome; of these, 71 (60.7%) justified the choice of target difference, most commonly, using estimates from pilot studies (31; 26.5%), standardized effect sizes (20; 17.1%), or evidence reviews (16; 13.7%); patient or stakeholder opinions were used to justify the target difference in 8 (6.8%). Limitations of this study are the need for trials to be registered in ClinicalTrials.gov, which may have reduced generalizability, and extracting information only from the primary trial report. CONCLUSIONS: In this study, we observed that pragmatic trials rarely report patient and public engagement and do not commonly use PROs as primary outcomes. When provided, target differences are often not justified and rarely informed by patients and stakeholders. Research funders, scientific journals, and institutions should support trialists to incorporate patient engagement to fulfill the mandate of pragmatic trials to be patient centered.

Delay in childhood vaccinations during the COVID-19 pandemic.

OBJECTIVES: In many jurisdictions, routine medical care was reduced in response to the COVID-19 pandemic. The objective of this study was to determine whether the frequency of on-time routine childhood vaccinations among children age 0-2 years was lower following the COVID-19 declaration of emergency in Ontario, Canada, on March 17, 2020, compared to prior to the pandemic. METHODS: We conducted a longitudinal cohort study of healthy children aged 0-2 years participating in the TARGet Kids! primary care research network in Toronto, Canada. A logistic mixed effects regression model was used to determine odds ratios (ORs) for delayed vaccination (> 30 days vs. ≤ 30 days from the recommended date) before and after the COVID-19 declaration of emergency, adjusted for confounding variables. A Cox proportional hazards model was used to explore the relationship between the declaration of emergency and time to vaccination. RESULTS: Among 1277 children, the proportion of on-time vaccinations was 81.8% prior to the COVID-19 declaration of emergency and 62.1% after (p < 0.001). The odds of delayed vaccination increased (odds ratio = 3.77, 95% CI: 2.86-4.96), and the hazard of administration of recommended vaccinations decreased after the declaration of emergency (hazard ratio = 0.75, 95% CI: 0.60-0.92). The median vaccination delay time was 5 days (95% CI: 4-5 days) prior to the declaration of emergency and 17 days (95% CI: 12-22 days) after. CONCLUSION: The frequency of on-time routine childhood vaccinations was lower during the first wave of the COVID-19 pandemic. Sustained delays in routine vaccinations may lead to an increase in rates of vaccine-preventable diseases.

RéSUMé: OBJECTIFS: Dans plusieurs juridictions, les soins médicaux systématiques étaient réduits à cause de la pandémie de COVID-19. L'objectif de cette étude était de déterminer si la fréquence de donner les vaccinations systématiques aux enfants de l'âge de 0 à 2 ans était réduite en conséquence de la déclaration d'urgence de COVID-19 en Ontario, Canada dès le 17 mars 2020, comparer avec la fréquence avant la pandémie. MéTHODES: Nous avons mené une étude de cohorte longitudinale des enfants en bonne santé âgés de 0 à 2 ans qui participent dans le réseau de recherche en soins primaires TARGet Kids! à Toronto, Canada. Un modèle de régression logistique à effets mixtes était utilisé pour déterminer le rapport de cotes (RC) pour les vaccinations retardées (> 30 jours c. ≤ 30 jours de la date recommandée) et était équilibré pour les variables confondantes. Le modèle à risques proportionnels de Cox était utilisé pour examiner le lien entre la déclaration d'urgence et le temps jusqu'à la vaccination. RéSULTATS: Parmi 1 277 enfants, la proportion de vaccination à l'heure était 81,8 % avant la déclaration d'urgence de COVID-19 et 62,1 % après (p < 0,001). La possibilité de vaccination retardée était augmentée (RC = 3,77; IC95% : 2,86­4,96), et le taux d'administration recommandé pour les vaccinations était réduit après la déclaration d'urgence (ratio de hasard = 0,75; IC95% : 0,60­0,92). Le médian temps de retard pour les vaccinations était 5 jours (IC95% : 4­5 jours) avant la déclaration d'urgence et 17 jours (IC95% : 12­22 jours) après. CONCLUSION: La fréquence de vaccinations systématiques aux enfants à l'heure était inférieure pendant la première vague de la pandémie COVID-19. Des retards soutenus pour recevoir les vaccinations systématiques peuvent entrainer une augmentation des taux de maladies évitables par la vaccination.

Review of pragmatic trials found that multiple primary outcomes are common but so too are discrepancies between protocols and final reports.

OBJECTIVES: To describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials. STUDY DESIGN AND SETTING: Individually randomized trials labeled as pragmatic, published 2014-2019 in MEDLINE and registered with ClinicalTrials.gov. RESULTS: We identified 262 final reports and located protocols for 159 (61%); primary outcomes were clearly reported in 145 (91%) protocols and 256 (98%) final reports. Thirty (19%) protocols and 38 (15%) final reports had multiple primary outcomes. Primary outcomes were present and identical in 128 (81%) matched protocol-final reports. Among 140 pairs with target sample sizes reported, 28 (20.0%) reduced their target sample size (mean 543 fewer participants per trial) and 16 (11.4%) increased it (mean 192 more participants per trial). Thirteen (29.5%) provided an explanation. Only 2 of 30 (7%) protocols and 4 of 38 (11%) final reports with co-primary outcomes explained how results would be interpreted in light of multiplicity; 21 of 30 (70%) protocols and 20 of 38 (53%) final reports accounted for co-primary outcomes in power calculations. CONCLUSION: Co-primary outcomes are common in pragmatic trials; improved transparency around design and analysis decisions involving co-primary outcomes is required.

Patient and family engagement in the development of core outcome sets for two rare chronic diseases in children.

BACKGROUND: Core outcome sets (COS) are lists of consensus-determined outcomes to be measured and reported in all clinical research studies within a disease area. While including patients and families in COS development to improve their relevance and applicability to patient values is key, there is limited literature documenting practical barriers and facilitators to successful patient engagement in COS development. In this paper, as researchers and patient partners, we provide a resource for COS developers to meaningfully and effectively engage patients and families. MAIN BODY: To establish a consensus-based COS for children with two inherited metabolic diseases (medium-chain acyl-CoA dehydrogenase deficiency and phenylketonuria), we conducted an evidence review, Delphi survey, and workshop. Two adult patient partner co-investigators co-developed the study protocol, co-designed strategies to address challenges with incorporating patient perspectives, and led all patient engagement activities, including communication with a group of family advisors. Seven adult family advisors received training about COS development and subsequently contributed to Delphi survey development, outcome definitions, the consensus workshop, and selection of outcome measurement instruments. Patient partner co-investigators and family advisors were essential to the successful design, conduct, and completion of the two COS. Patient partner co-investigators supported the understanding, inclusion and engagement of family advisors, and helped develop accessible tools to determine patient-oriented outcome measurement instruments. Patient partner co-investigators and family advisors collaborated with the study team to co-develop surveys, modify technical language, and recruit participants to the study. Together, we addressed challenges to patient engagement in COS development such as unfamiliarity with study methods, comprehensibility of materials and ongoing engagement, and power imbalances between team members. CONCLUSION: Our approach to patient and family engagement in COS development for two rare conditions for children was feasible and considered valuable by all study team members, including patients and family members, in improving the relevance of the deliverable to patients. This approach to patient engagement in developing COS can be applied to other paediatric disease contexts, allowing patient and family perspectives to influence the direction of future studies to develop COS.

Core outcome sets (COS) are lists of outcomes agreed upon by a group of people to be measured and reported in studies about certain diseases and populations. Core outcomes are meant to represent what is useful to study from the perspectives of health care providers, researchers and patients. For researchers who seek to include patients in the development of a COS, there is little guidance about how to do this well. We recently developed COS for two rare diseases in children, medium-chain acyl-CoA dehydrogenase deficiency and phenylketonuria. We did this by reviewing available information from published research, surveying health care providers, researchers, and patients, and eventually coming to agreement during a workshop. We included two adult patient partner co-researchers who helped design the COS study and co-developed the patient engagement strategy. These partners formed relationships with seven adult family advisors, who helped ensure that materials were accessible, participated in outcome selection, and helped select tools to measure core outcomes. Strategies we used to engage patient partners included a) training about both the scientific research process and how to help other researchers in the future, and b) frequent communication about study progress and how family advisor feedback was used. Also, we made sure that the impacts of power imbalances between health care providers, researchers and patients were low. Our approach to patient engagement in COS development for two rare conditions in children proved to be both feasible and considered valuable by all study team members, including patient partners and family advisors. To include patient perspectives and values, future COS developers may take a similar approach.

Cow's milk fat and child adiposity: a prospective cohort study.

BACKGROUND: International guidelines recommend children aged 9 months to 2 years consume whole (3.25%) fat cow's milk, and children older than age 2 years consume reduced (0.1-2%) fat cow's milk to prevent obesity. The objective of this study was to evaluate the longitudinal relationship between cow's milk fat (0.1-3.25%) intake and body mass index z-score (zBMI) in childhood. We hypothesized that higher cow's milk fat intake was associated with lower zBMI. METHODS: A prospective cohort study of children aged 9 months to 8 years was conducted through the TARGet Kids! primary care research network. The exposure was cow's milk fat consumption (skim (0.1%), 1%, 2%, whole (3.25%)), measured by parental report. The outcome was zBMI. Height and weight were measured by trained research assistants and zBMI was determined according to WHO growth standards. A linear mixed effects model and logistic generalized estimating equations were used to determine the longitudinal association between cow's milk fat intake and child zBMI. RESULTS: Among children aged 9 months to 8 years (N = 7467; 4699 of whom had repeated measures), each 1% increase in cow's milk fat consumed was associated with a 0.05 lower zBMI score (95% CI -0.07 to -0.03, p < 0.0001) after adjustment for covariates including volume of milk consumed. Compared to children who consumed reduced fat (0.1-2%) milk, there was evidence that children who consumed whole milk had 16% lower odds of overweight (OR = 0.84, 95% CI 0.77 to 0.91, p < 0.0001) and 18% lower odds of obesity (OR = 0.82, 95% CI 0.68 to 1.00, p = 0.047). CONCLUSIONS: Guidelines for reduced fat instead of whole cow's milk during childhood may not be effective in preventing overweight or obesity.

Public health preventive measures and child health behaviours during COVID-19: a cohort study.

OBJECTIVE: The primary objective was to determine the association between public health preventive measures and children's outdoor time, sleep duration, and screen time during COVID-19. METHODS: A cohort study using repeated measures of exposures and outcomes was conducted in healthy children (0 to 10 years) through The Applied Research Group for Kids (TARGet Kids!) COVID-19 Study of Children and Families in Toronto, Canada, between April 14 and July 15, 2020. Parents were asked to complete questionnaires about adherence to public health measures and children's health behaviours. The primary exposure was the average number of days that children practiced public health preventive measures per week. The three outcomes were children's outdoor time, total screen time, and sleep duration during COVID-19. Linear mixed-effects models were fitted using repeated measures of primary exposure and outcomes. RESULTS: This study included 554 observations from 265 children. The mean age of participants was 5.5 years, 47.5% were female and 71.6% had mothers of European ethnicity. Public health preventive measures were associated with shorter outdoor time (-17.2; 95% CI -22.07, -12.40; p < 0.001) and longer total screen time (11.3; 95% CI 3.88, 18.79; p = 0.003) during COVID-19. The association with outdoor time was stronger in younger children (<5 years), and the associations with total screen time were stronger in females and in older children (≥5 years). CONCLUSION: Public health preventive measures during COVID-19 were associated with a negative impact on the health behaviours of Canadian children living in a large metropolitan area.

RéSUMé: OBJECTIF: L'objectif principal était de déterminer la relation entre les mesures préventives de la santé publique et le temps passé en plein air, la durée du sommeil ainsi que le temps passé devant l'écran par les enfants pendant COVID-19. MéTHODES: Une étude de cohorte utilisant des mesures répétées des expositions et des effets a été menée chez des enfants en bonne santé (0 à 10 ans) par l'entremise de l'Étude COVID-19 sur les Enfants et Familles du Groupe de Recherche Appliquée pour les Enfants (TARGet Kids!) à Toronto, au Canada, entre le 14 avril et le 15 juillet 2020. Les parents ont été invités à remplir des questionnaires sur adhésion aux mesures préventives de la santé publique et les comportements de santé des enfants. La principale exposition était le nombre moyen de jours par semaine durant lesquels les enfants pratiquaient des mesures préventives de la santé publique. Les trois effets étaient le temps passé en plein air par les enfants, le temps total passé devant l'écran et la durée du sommeil pendant le COVID-19. Des modèles linéaires à effets mixtes ont été ajustés en utilisant des mesures répétées d'exposition primaire et des effets. RéSULTATS: Cette étude comprend 554 observations sur 265 enfants. L'âge moyen des participants était de 5,5 ans, 47,5 % étaient des femmes et 71,6 % avaient des mères d'origine européenne. Les mesures préventives de la santé publique ont été associées à un temps passé en plein air plus court (-17,2 ; IC 95% -22,07, -12,40; p < 0,001) et à un temps total devant l'écran plus long (11,3 ; IC 95% 3,88, 18,79; p = 0,003) pendant la COVID-19. La relation avec le temps passé en plein air était plus importante chez les jeunes enfants (<5 ans), et les relations avec le temps total passé devant l'écran étaient plus importantes chez les enfants de sexe féminin et les enfants plus âgés (≥5 ans). CONCLUSION: Les mesures préventives de la santé publique prises lors de COVID-19 ont été associées à un impact négatif sur les comportements de santé des enfants canadiens vivant dans une grande région métropolitaine.

Forming a Parent And Clinician Team (PACT) in a cohort of healthy children.

BACKGROUND: Engaging parents in child health research can facilitate choosing relevant research questions, recruiting participants who reflect the diversity of large communities, and disseminating study results to communities in accessible ways. MAIN BODY: Primary care well-child visit systems present a foundation for trusting relationships between families and clinicians, lending itself well to a system where health research is embedded into the delivery of health care. We provide an example of a practice-based research network called TARGet Kids!, which is a longitudinal cohort study of children from birth to adolescence. Researchers and clinicians have partnered with parents of children participating in TARGet Kids! to ensure child health research is centred on family values and preferences. A Parent And Clinician Team (PACT) was formed to set research priorities, co-design research protocols, troubleshoot issues, and communicate research to knowledge users. CONCLUSION: This partnership will facilitate child health research which is feasible, relevant and inclusive for improving children's health care and public health policy.

Including parents as partners in child health research can lead to choosing relevant research questions, recruiting children to participate who represent the general population, and sharing study results with communities. The structure of primary care offered to children presents an opportunity for building trusting relationships between families and clinicians, which may encourage parents and health care providers to participate in child health research. We provide an example of an ongoing study called TARGet Kids!, which includes children from birth to adolescence who attend regular health care visits. Researchers and clinicians have partnered with parents of children participating in TARGet Kids! to ensure child health research is centered on family values and preferences. A Parent And Clinician Team (PACT) was formed to set research priorities, design research studies together, troubleshoot issues, and communicate research findings back to health care providers, families, and policy makers. This partnership will lay a foundation for child health research which is practical, relevant to families and inclusive for improving children's health care and public health policy.

Automated Self-Administered 24-H Dietary Assessment Tool (ASA24) recalls for parent proxy-reporting of children's intake (> 4 years of age): a feasibility study.

BACKGROUND: Robust measurement of dietary intake in population studies of children is critical to better understand the diet-health nexus. It is unknown whether parent proxy-report of children's dietary intake through online 24-h recalls is feasible in large cohort studies. OBJECTIVES: The primary objective of this study was to describe the feasibility of the Automated Self-Administered 24-h Dietary Assessment Tool (ASA24) to measure parent proxy-reported child dietary intake. A secondary objective was to compare intake estimates with those from national surveillance. METHODS: Parents of children aged 4-15 years participating in the TARGet Kids! research network in Toronto, Canada were invited by email to complete an online ASA24-Canada-2016 recall for their child, with a subsample prompted to complete a second recall about 2 weeks later. Descriptive statistics were reported for ASA24 completion characteristics and intake of several nutrients. Comparisons were made to the 2015 Canadian Community Health Survey (CCHS) 24-h recall data. RESULTS: A total of 163 parents completed the first recall, and 46 completed the second, reflecting response rates of 35% and 59%, respectively. Seven (4%) first recalls and one (2%) second recall were excluded for ineligibility, missing data, or inadvertent parental self-report. The median number of foods reported on the first recall was 18.0 (interquartile range (IQR) 6.0) and median time to complete was 29.5 min (IQR 17.0). Nutrient intakes for energy, total fat, protein, carbohydrates, fiber, sodium, total sugars, and added sugars were similar across the two recalls and the CCHS. CONCLUSIONS: The ASA24 was found to be feasible for parent proxy-reporting of children's intake and to yield intake estimates comparable to those from national surveillance, but strategies are needed to increase response rate and support completion to enhance generalizability.