Priority topics for child and family health research in community-based paediatric health care according to caregivers and health care professionals.

Background: Patient-oriented research (POR) aligns research with stakeholders' priorities to improve health services and outcomes. Community-based health care settings offer an opportunity to engage stakeholders to determine the most important research topics to them. Our objectives were to identify unanswered questions that stakeholders had regarding any aspect of child and family health and prioritize their 'top 10' questions. Methods: We followed the James Lind Alliance (JLA) priority setting methodology in partnership with stakeholders from the Northeast Community Health Centre (NECHC; Edmonton, Canada). We partnered with stakeholders (five caregivers, five health care professionals [HCPs]) to create a steering committee. Stakeholders were surveyed in two rounds (n = 125 per survey) to gather and rank-order unanswered questions regarding child and family health. A final priority setting workshop was held to finalize the 'top 10' list. Results: Our initial survey generated 1,265 submissions from 100 caregivers and 25 HCPs. Out of scope submissions were removed and similar questions were combined to create a master list of questions (n = 389). Only unanswered questions advanced (n = 108) and were rank-ordered through a second survey by 100 caregivers and 25 HCPs. Stakeholders (n = 12) gathered for the final workshop to discuss and finalize the 'top 10' list. Priority questions included a range of topics, including mental health, screen time, COVID-19, and behaviour. Conclusion: Our stakeholders prioritized diverse questions within our 'top 10' list; questions regarding mental health were the most common. Future patient-oriented research at this site will be guided by priorities that were most important to caregivers and HCPs.

The Impacts of COVID-19 Restrictions on Physical Activity in Children and Youth: A Systematic Review of Qualitative Evidence.

BACKGROUND: The objectives of this systematic review were to synthesize qualitative evidence on the impacts of COVID-19 restrictions on physical activity (PA) for children and youth, and explore factors perceived to influence those impacts. METHODS: Five databases (MEDLINE, Embase, SPORTDiscus, ERIC, and CINAHL) were searched initially in June 2021 and updated in December 2021 to locate qualitative articles considering COVID-19 restrictions and PA for children and youth (≤18 y old), in any setting. Eligibility, quality assessments, and data extraction were completed by 2 independent reviewers. Data were synthesized using meta-aggregation with confidence of findings rated using ConQual. RESULTS: After screening 3505 records, 15 studies were included. Curriculum-based PA, organized sport, and active transportation were negatively impacted by COVID-19 restrictions. Negative changes were affected by COVID-19 exposure risks, inadequate instruction, poor access, screen time, and poor weather. Unstructured PA was inconsistently impacted; outdoor unstructured PA increased for some. Positive changes were facilitated by family co-participation, availability of outdoor space, and perceived mental health benefits. CONCLUSION: Qualitative data indicated restrictions had a predominantly negative impact on PA for children and youth, but inconsistent impacts on unstructured PA. The improved contextual understanding offered by our review will be foundational knowledge for health strategies moving forward.

Quantifying unused opioids following emergency and ambulatory care: A systematic review and meta-analysis.

Objective: To quantify unused opioids among adult and pediatric patients discharged from the emergency department (ED) or ambulatory care settings with a prescription for acute pain. Methods: We searched MEDLINE, Embase, CINHAL, PsycINFO, the Cochrane Library, and the gray literature from inception to April 29, 2021. We included observational studies in which any patient with an acutely painful condition received a prescription for an opioid on discharge from an outpatient care setting, and unused opioids were quantified. Two reviewers screened records for eligibility, extracted data, and conducted the quality assessment. Where possible, we pooled data and otherwise described the results of studies narratively. Total unused prescriptions were synthesized using a weighted average. Random effects models were used, and heterogeneity was measured by the I2 statistic. Our primary outcome was the quantity of unused opioid medication available after receiving a prescription for acute pain. Secondary outcomes were the proportion of patients with unused opioids following a prescription, the proportion of patients using no opioids, morphine equivalents of unused opioids, and factors associated with leftover opioids. Results: In this systematic review and meta-analysis of 9 studies in emergency and ambulatory care settings, 59.6% of prescribed opioids remained unused; pediatric patients had 69.3% of their prescriptions remaining, compared to 54.6% among adult patients. The highest proportion of unused opioids was found following dental extractions (82.6%). Conclusions and Relevance: More than 50% of opioids remain unused following prescriptions for acute pain. Responsible prescribing must be accompanied by education on safer use, storage, and disposal.

Nonmedical Opioid Use After Short-term Therapeutic Exposure in Children: A Systematic Review.

CONTEXT: Opioid-related harms continue to rise for children and youth. Analgesic prescribing decisions are challenging because the risk for future nonmedical opioid use or disorder is unclear. OBJECTIVE: To synthesize research examining the association between short-term therapeutic opioid exposure and future nonmedical opioid use or opioid use disorder and associated risk factors. DATA SOURCES: We searched 11 electronic databases. STUDY SELECTION: Two reviewers screened studies. Studies were included if: they were published in English or French, participants had short-term (≤14 days) or an unknown duration of therapeutic exposure to opioids before 18 years, and reported opioid use disorder or misuse. DATA EXTRACTION: Data were extracted, and methodologic quality was assessed by 2 reviewers. Data were summarized narratively. RESULTS: We included 21 observational studies (49 944 602 participants). One study demonstrated that short-term therapeutic exposure may be associated with opioid abuse; 4 showed an association between medical and nonmedical opioid use without specifying duration of exposure. Other studies reported on prevalence or incidence of nonmedical use after medical exposure to opioids. Risk factors were contradictory and remain unclear. LIMITATIONS: Most studies did not specify duration of exposure and were of low methodologic quality, and participants might not have been opioid naïve. CONCLUSIONS: Some studies suggest an association between lifetime therapeutic opioid use and nonmedical opioid use. Given the lack of clear evidence regarding short-term therapeutic exposure, health care providers should carefully evaluate pain management options and educate patients and caregivers about safe, judicious, and appropriate use of opioids and potential signs of misuse.

Burden of illness in infants and young children hospitalized for respiratory syncytial virus: A rapid review.

Respiratory syncytial virus (RSV) infections are common among young children and represent a significant burden to patients, their families and the Canadian health system. Here we conduct a rapid review of the burden of RSV illness in children 24 months of age or younger. Four databases (Medline, Embase, Cochrane Database of Clinical Trials, ClinicalTrials.gov from 2014 to 2018), grey literature and reference lists were reviewed for studies on the following: children with or without a risk factor, without prophylaxis and with lab-confirmed RSV infection. Of 29 studies identified, 10 provided within-study comparisons and few examined clinical conditions besides prematurity. For infants of 33-36 weeks gestation (wGA) versus term infants, there was low-to-moderate certainty evidence for an increase in RSV-hospitalizations (n=599,535 infants; RR 2.05 [95% CI 1.89-2.22]; 1.3 more per 100 [1.1-1.5 more]) and hospital length of stay (n=7,597 infants; mean difference 1.00 day [95% CI 0.88-1.12]). There was low-to-moderate certainty evidence of little-to-no difference for infants born at 29-32 versus 33-36 wGA for hospitalization (n=12,812 infants; RR 1.20 [95% CI 0.92-1.56]). There was low certainty evidence of increased mechanical ventilation for hospitalized infants born at 29-32 versus 33-35 wGA (n=212 infants; RR 1.58, 95% CI 0.94-2.65). Among infants born at 32-35 wGA, hospitalization for RSV in infancy may be associated with increased wheeze and asthma-medication use across six-year follow-up (RR range 1.3-1.7). Children with versus without Down syndrome may have increased hospital length of stay (n=7,206 children; mean difference 3.00 days, 95% CI 1.95-4.05; low certainty). Evidence for other within-study comparisons was of very low certainty. In summary, prematurity is associated with greater risk for RSV-hospitalization and longer hospital length of stay, and Down syndrome may be associated with longer hospital stay for RSV. Respiratory syncytial virus-hospitalization in infancy may be associated with greater wheeze and asthma-medication use in early childhood. Lack of a comparison group was a major limitation for many studies.

Considerations for Health Researchers Using Social Media for Knowledge Translation: Multiple Case Study.

BACKGROUND: Despite extensive literature describing the use of social media in health research, a gap exists around best practices in establishing, implementing, and evaluating an effective social media knowledge translation (KT) and exchange strategies. OBJECTIVE: This study aims to examine successes, challenges, and lessons learned from using social media within health research and to create practical considerations to guide other researchers. METHODS: The Knowledge Translation Platform of the Alberta Strategy for Patient-Oriented Research SUPPORT Unit formed a national working group involving platform staff, academics, and a parent representative with experience using social media for health research. We collected and analyzed 4 case studies that used a variety of social media platforms and evaluation methods. The case studies covered a spectrum of initiatives from participant recruitment and data collection to dissemination, engagement, and evaluation. Methods and findings from each case study as well as barriers and facilitators encountered were summarized. Through iterative discussions, we converged on recommendations and considerations for health researchers planning to use social media for KT. RESULTS: We provide recommendations for elements to consider when developing a social media KT strategy: (1) set a clear goal and identify a theory, framework, or model that aligns with the project goals and objectives; (2) understand the intended audience (use social network mapping to learn what platforms and social influences are available); (3) choose a platform or platforms that meet the needs of the intended audience and align well with the research team's capabilities (can you tap into an existing network, and what mode of communication does it support?); (4) tailor messages to meet user needs and platform requirements (eg, plain language and word restrictions); (5) consider timing, frequency, and duration of messaging as well as the nature of interactions (ie, social filtering and negotiated awareness); (6) ensure adequate resources and personnel are available (eg, content creators, project coordinators, communications experts, and audience stakeholder or patient advocate); (7) develop an evaluation plan a priori driven by goals and types of data available (ie, quantitative and qualitative); and (8) consider ethical approvals needed (driven by evaluation and type of data collection). CONCLUSIONS: In the absence of a comprehensive framework to guide health researchers using social media for KT, we provide several key considerations. Future research will help validate the proposed components and create a body of evidence around best practices for using and evaluating social media as part of a KT strategy.

Performance and usability of machine learning for screening in systematic reviews: a comparative evaluation of three tools.

BACKGROUND: We explored the performance of three machine learning tools designed to facilitate title and abstract screening in systematic reviews (SRs) when used to (a) eliminate irrelevant records (automated simulation) and (b) complement the work of a single reviewer (semi-automated simulation). We evaluated user experiences for each tool. METHODS: We subjected three SRs to two retrospective screening simulations. In each tool (Abstrackr, DistillerSR, RobotAnalyst), we screened a 200-record training set and downloaded the predicted relevance of the remaining records. We calculated the proportion missed and workload and time savings compared to dual independent screening. To test user experiences, eight research staff tried each tool and completed a survey. RESULTS: Using Abstrackr, DistillerSR, and RobotAnalyst, respectively, the median (range) proportion missed was 5 (0 to 28) percent, 97 (96 to 100) percent, and 70 (23 to 100) percent for the automated simulation and 1 (0 to 2) percent, 2 (0 to 7) percent, and 2 (0 to 4) percent for the semi-automated simulation. The median (range) workload savings was 90 (82 to 93) percent, 99 (98 to 99) percent, and 85 (85 to 88) percent for the automated simulation and 40 (32 to 43) percent, 49 (48 to 49) percent, and 35 (34 to 38) percent for the semi-automated simulation. The median (range) time savings was 154 (91 to 183), 185 (95 to 201), and 157 (86 to 172) hours for the automated simulation and 61 (42 to 82), 92 (46 to 100), and 64 (37 to 71) hours for the semi-automated simulation. Abstrackr identified 33-90% of records missed by a single reviewer. RobotAnalyst performed less well and DistillerSR provided no relative advantage. User experiences depended on user friendliness, qualities of the user interface, features and functions, trustworthiness, ease and speed of obtaining predictions, and practicality of the export file(s). CONCLUSIONS: The workload savings afforded in the automated simulation came with increased risk of missing relevant records. Supplementing a single reviewer's decisions with relevance predictions (semi-automated simulation) sometimes reduced the proportion missed, but performance varied by tool and SR. Designing tools based on reviewers' self-identified preferences may improve their compatibility with present workflows. SYSTEMATIC REVIEW REGISTRATION: Not applicable.

Potential Reduction of Symptoms With the Use of Persuasive Systems Design Features in Internet-Based Cognitive Behavioral Therapy Programs for Children and Adolescents With Anxiety: A Realist Synthesis.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) for children and adolescents is a persuasive system that combines 3 major components to therapy-therapeutic content, technological features, and interactions between the user and program-intended to reduce users' anxiety symptoms. Several reviews report the effectiveness of iCBT; however, iCBT design and delivery components differ widely across programs, which raise important questions about how iCBT effects are produced and can be optimized. OBJECTIVE: The objective of this study was to review and synthesize the iCBT literature using a realist approach with a persuasive systems perspective to (1) document the design and delivery components of iCBT and (2) generate hypotheses as to how these components may explain changes in anxiety symptoms after completing iCBT. METHODS: A multi-strategy search identified published and gray literature on iCBT for child and adolescent anxiety up until June 2019. Documents that met our prespecified inclusion criteria were appraised for relevance and methodological rigor. Data extraction was guided by the persuasive systems design (PSD) model. The model describes 28 technological design features, organized into 4 categories that help users meet their health goals: primary task support, dialogue support, system credibility support, and social support. We generated initial hypotheses for how PSD (mechanisms) and program delivery (context of use) features were linked to symptom changes (outcomes) across iCBT programs using realist and meta-ethnographic techniques. These hypothesized context-mechanism-outcome configurations were refined during analysis using evidence from the literature to improve their explanatory value. RESULTS: A total of 63 documents detailing 15 iCBT programs were included. A total of six iCBT programs were rated high for relevance, and most studies were of moderate-to-high methodological rigor. A total of 11 context-mechanism-outcome configurations (final hypotheses) were generated. Configurations primarily comprised PSD features from the primary task and dialogue support categories. Several key PSD features (eg, self-monitoring, simulation, social role, similarity, social learning, and rehearsal) were consistently reported in programs shown to reduce anxiety; many features were employed simultaneously, suggesting synergy when grouped. We also hypothesized the function of PSD features in generating iCBT impacts. Adjunct support was identified as an important aspect of context that may have complemented certain PSD features in reducing users' anxiety. CONCLUSIONS: This synthesis generated context-mechanism-outcome configurations (hypotheses) about the potential function, combination, and impact of iCBT program components thought to support desired program effects. We suggest that, when delivered with adjunct support, PSD features may contribute to reduced anxiety for child and adolescent users. Formal testing of the 11 configurations is required to confirm their impact on anxiety-based outcomes. From this we encourage a systematic and deliberate approach to iCBT design and evaluation to increase the pool of evidence-based interventions available to prevent and treat children and adolescents with anxiety.

Correction: Barriers and enablers for adopting lifestyle behavior changes in adolescents with obesity: A multi-centre, qualitative study.

[This corrects the article DOI: 10.1371/journal.pone.0209219.].

Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis.

OBJECTIVES: For 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. METHODS: For this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics. RESULTS: Eighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a DMC was more common among multicentre than single centre trials (n=41/132, 31% vs n=14/139, 10%, p<0.001) and industry-sponsored trials compared with those sponsored by other sources (n=16/50, 32% vs n=39/250, 16%, p=0.009). Trials that reported a DMC enrolled more participants than those that did not (median [range]): 224 (10-60480) vs 91 (10-9528) (p<0.001). Only 25% of these trials reported interim analyses, and 42% reported stopping rules. Less than half (n=143/300, 48%) of trials reported on adverse events, and 72% (n=215/300) reported on harm-related endpoints. Trials that reported a DMC compared with those that did not were more likely to report adverse events (n=43/55, 78% vs 100/245, 41%, p<0.001) and harm-related endpoints (n=52/55, 95% vs. 163/245, 67%, p<0.001). Only 32% of drug trials reported a DMC; 18% and 19% did not report on adverse events or harm-related endpoints, respectively. CONCLUSIONS: The reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal.

Adolescents' involvement in decision-making for pediatric weight management: A multi-centre, qualitative study on perspectives of adolescents and health care providers.

OBJECTIVE: To explore adolescents' and health care providers' (HCPs) perspectives on adolescents' involvement in decision-making within multidisciplinary clinical care for pediatric weight management. METHODS: In this multi-centre, qualitative description study, we purposefully recruited 13-17-year-olds with overweight or obesity and HCPs from two pediatric weight management clinics in Edmonton and Ottawa, Canada. Participants completed one-on-one, in-person, semi-structured interviews (adolescents) or focus groups (HCPs), which were audio-recorded, transcribed verbatim, and managed using NVivo 11. Data were analyzed by two independent researchers using inductive thematic analysis and the congruent methodological approach for group interactions. RESULTS: A total of 19 adolescents and 16 HCPs participated. Three themes were identified in relation to adolescents' decision-making for weight management, including (i) conditions for adolescent involvement, (ii) preferences for adolescent involvement, and (iii) extent of parental involvement. CONCLUSIONS: Although adolescents and HCPs positively valued adolescents' involvement in making decisions regarding their weight and health, the extent to which adolescents wished to be involved in the decision-making process varied between individuals and families. PRACTICE IMPLICATIONS: HCPs are encouraged to include adolescents and families in their health services delivery, including consulting individually with adolescents and tailoring care to their expectations regarding decision-making.

Design and Delivery Features That May Improve the Use of Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Anxiety: A Realist Literature Synthesis With a Persuasive Systems Design Perspective.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) is a persuasive system as its design combines therapeutic content, technological features, and interactions between the user and the program to reduce anxiety for children and adolescents. How iCBT is designed and delivered differs across programs. Although iCBT is considered an effective approach for treating child and adolescent anxiety, rates of program use (eg, module completion) are highly variable for reasons that are not clear. As the extent to which users complete a program can impact anxiety outcomes, understanding what iCBT design and delivery features improve program use is critical for optimizing treatment effects. OBJECTIVE: The objectives of this study were to use a realist synthesis approach to explore the design and delivery features of iCBT for children and adolescents with anxiety as described in the literature and to examine their relationship to program use outcomes. METHODS: A search of published and gray literature was conducted up to November 2017. Prespecified inclusion criteria identified research studies, study protocols, and program websites on iCBT for child and adolescent anxiety. Literature was critically appraised for relevance and methodological rigor. The persuasive systems design (PSD) model, a comprehensive framework for designing and evaluating persuasive systems, was used to guide data extraction. iCBT program features were grouped under 4 PSD categories-Primary task support, Dialogue support, System credibility support, and Social support. iCBT design (PSD Mechanisms) and delivery features (Context of use) were linked to program use (Outcomes) using meta-ethnographic methods; these relationships were described as Context-Mechanism-Outcome configurations. For our configurations, we identified key PSD features and delivery contexts that generated moderate-to-high program use based on moderate-to-high quality evidence found across multiple iCBT programs. RESULTS: A total of 44 documents detailing 10 iCBT programs were included. Seven iCBT programs had at least one document that scored high for relevance; most studies were of moderate-to-high methodological rigor. We developed 5 configurations that highlighted 8 PSD features (Tailoring, Personalization [Primary task supports]; Rewards, Reminders, Social role [Dialogue supports]; and Trustworthiness, Expertise, Authority [System credibility supports]) associated with moderate-to-high program use. Important features of delivery Context were adjunct support (a face-to-face, Web- or email-based communications component) and whether programs targeted the prevention or treatment of anxiety. Incorporating multiple PSD features may have additive or synergistic effects on program use. CONCLUSIONS: The Context-Mechanism-Outcome configurations we developed suggest that, when delivered with adjunct support, certain PSD features contribute to moderate-to-high use of iCBT prevention and treatment programs for children and adolescents with anxiety. Standardization of the definition and measurement of program use, formal testing of individual and combined PSD features, and use of real-world design and testing methods are important next steps to improving how we develop and deliver increasingly useful treatments to target users.

Consent and recruitment: the reporting of paediatric trials published in 2012.

OBJECTIVES: We evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets. METHODS: For this cross-sectional evaluation, we searched the Cochrane Central Register of Controlled Trials for paediatric trials published in 2012 and randomly selected 300 that reported on outcomes for participants aged ≤21 years. We collected data on consent and recruitment procedures for each trial and undertook descriptive analyses in SPSS statistics V.23. RESULTS: All but one trial (99.7%) used a standard recruitment strategy. Most (92%) trials reported that consent was obtained but only 13% reported who obtained consent. Two-thirds (65%) of trials included school-aged participants, and of these 68% reported obtaining assent. Half (50%) of the trials reported who the trial information was targeted to. Most trials (75%) of school-aged participants targeted information towards children or children and their parents. Fourteen per cent of trials reported using incentives, half (50%) of which were in the form of compensation. Only 48% of trials reported sufficient data to determine if their recruitment targets were achieved. Of these, 70% achieved their targets. CONCLUSIONS: Notable reporting shortcomings included: how families were recruited into the trial, who obtained consent and/or assent and how, who trial information was directed to, whether incentives were used and sufficient data to determine if the recruitment target was achieved. Forthcoming paediatric-specific reporting standards may improve reporting in this priority area. Our data provide a baseline for ongoing monitoring of the state of the research.

Barriers and enablers for adopting lifestyle behavior changes in adolescents with obesity: A multi-centre, qualitative study.

BACKGROUND: Many adolescents with obesity do not meet recommendations for nutrition, physical and sedentary activities, and sleep habits, all of which can influence weight management. OBJECTIVE: To explore barriers and enablers that influenced the adoption of lifestyle behavior changes among adolescents receiving multidisciplinary clinical care for pediatric weight management. METHODS: In this multi-centre, qualitative description study, we used purposeful sampling to recruit 13-17 year olds (body mass index ≥85th percentile) enrolled in one of two pediatric weight management clinics in Edmonton and Ottawa, Canada. Adolescents participated in one-on-one, in-person, semi-structured interviews in English or French. Interviews lasted 30-60 minutes, were audio-recorded, transcribed verbatim, and managed using NVivo 11. Data were triangulated using transcripts, field notes, and memos and analyzed by two independent researchers using inductive, semantic thematic analysis. RESULTS: In total, 19 adolescents (12 Anglophone and 7 Francophone; 15.1±1.7 years old; 3.5±0.6 BMI z-score; n = 11 female; n = 13 Caucasian) participated. Adolescents reported diverse barriers to and enablers of healthy nutrition, physical and sedentary activities, and sleep habits, which we organized into the following themes: physiological mechanisms and physical health status, self-regulation for behavior change, controllability and competence beliefs, social relationships and interactions, and accessibility to and availability of opportunities for lifestyle enhancement. Across these themes and lifestyle areas, we identified three shared barriers and/or enablers, including the degree of controllability, the impact of mental health, and social pressures related to weight management. CONCLUSIONS: This research provides evidence that can be used to tailor interventions and health services delivery, including a focus on psychosocial well-being, to support adolescents with obesity in making and maintaining healthy lifestyle behavior changes.

Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan.

BACKGROUND: Although children have historically been excluded from clinical trials (CTs), many require medicines tested and approved in CTs, forcing health care providers to treat their pediatric patients based on extrapolated data. Unfortunately, traditional randomized CTs can be slow and resource-intensive, and they often require multi-center collaboration. However, an adaptive design (AD) framework for CTs could be used to increase the efficiency of pediatric CTs by incorporating prospectively planned modifications to CT methods without undermining the integrity or validity of the study. There are many possible adaptations, but each will have ethical, logistical, and statistical implications. It remains unclear which adaptations (or combinations thereof) will lead to real-world improvements in pediatric CT efficiency. This study will identify, evaluate, and synthesize the various regulatory, ethical, logistical, and statistical considerations and emerging issues of AD in CTs that could be used to evaluate the use of drugs in children. METHODS/DESIGN: Following the development of a peer-reviewed search strategy, a systematic review on AD in CTs will be conducted. Data on regulatory, ethical, logistic, and statistical considerations as well as population and trial design characteristics will be synthesized. A mixed-methods study including surveys and focus groups with regulators, research ethics board members, biostatisticians, clinicians, and scientists, as well as representatives from patient groups and the public will evaluate the opportunities and challenges in applying AD in trials enrolling children and propose recommendations on best practices. DISCUSSION: This study will deliver practical recommendations on the use of AD in pediatric CTs. Collaboration and consultation with national and global partners will ensure that our results meet the needs of researchers, regulators, and patients, both locally and globally, and that they remain current and relevant by engaging a wide variety of stakeholders. Overall, this research will enrich the knowledge base regarding if, how, and when AD can be used to answer research questions with fewer resources while still meeting the highest ethical standards and regulatory requirements for CTs. In turn, this will result in increased high-quality clinical research needed by health care providers so they have access to appropriate, population-specific evidence regarding the safe and effective use of medicines in children.

Impact of fatigue and insufficient sleep on physician and patient outcomes: a systematic review.

OBJECTIVES: For physicians in independent practice, we synthesised evidence on the (1) impacts of insufficient sleep and fatigue on health and performance, and patient safety and (2) effectiveness of interventions targeting insufficient sleep and fatigue. DESIGN: We systematically reviewed online literature. After piloting, one reviewer selected studies by title and abstract; full texts were then reviewed in duplicate. One reviewer extracted data; another verified a random 10% sample. Two reviewers assessed risk of bias. We pooled findings via meta-analysis when appropriate or narratively. DATA SOURCES: We searched Medline, Embase, PsycINFO, CINAHL and PubMed for published studies in April 2016; Medline was updated in November 2017. We searched Embase for conference proceedings, and hand-searched meeting abstracts, association and foundation websites. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: English or French language primary research studies published from 2000 to 2017 examining the effect of fatigue-related or sleep-related exposures or interventions on any outcome among physicians in independent practice and their patients. RESULTS: Of 16 154 records identified, we included 47 quantitative studies of variable quality. 28 studies showed associations between fatigue or insufficient sleep and physician health and well-being outcomes. 21 studies showed no association with surgical performance, and mixed findings for psychomotor performance, work performance and medical errors. We pooled data from six cohort studies for patient outcomes. For sleep deprived versus non-sleep deprived surgeons, we found no difference in patient mortality (n=60 436, relative risk (RR) 0.98, 95% CI 0.84 to 1.15, I2=0% (p=0.87)) nor postoperative complications (n=60 201, RR 0.99, 95% CI 0.95 to 1.03, I2=0% (p=0.45)). The findings for intraoperative complications and length of stay were considerably heterogeneous. CONCLUSIONS: Fatigue and insufficient sleep may be associated with negative physician health outcomes. Current evidence is inadequate to inform practice recommendations.

eMental Healthcare Technologies for Anxiety and Depression in Childhood and Adolescence: Systematic Review of Studies Reporting Implementation Outcomes.

BACKGROUND: Anxiety disorders and depression are frequent conditions in childhood and adolescence. eMental healthcare technologies may improve access to services, but their uptake within health systems is limited. OBJECTIVE: The objective of this review was to examine and describe how the implementation of eMental healthcare technologies for anxiety disorders and depression in children and adolescents has been studied. METHODS: We conducted a search of 5 electronic databases and gray literature. Eligible studies were those that assessed an eMental healthcare technology for treating or preventing anxiety or depression, included children or adolescents (<18 years), or their parents or healthcare providers and reported findings on technology implementation. The methodological quality of studies was evaluated using the Mixed Methods Appraisal Tool. Outcomes of interest were based on 8 implementation outcomes: acceptability (satisfaction with a technology), adoption (technology uptake and utilization), appropriateness ("fitness for purpose"), cost (financial impact of technology implementation), feasibility (extent to which a technology was successfully used), fidelity (implementation as intended), penetration ("spread" or "reach" of the technology), and sustainability (maintenance or integration of a technology within a healthcare service). For extracted implementation outcome data, we coded favorable ratings on measurement scales as "positive results" and unfavorable ratings on measurement scales as "negative results." Those studies that reported both positive and negative findings were coded as having "mixed results." RESULTS: A total of 46 studies met the inclusion criteria, the majority of which were rated as very good to excellent in methodological quality. These studies investigated eMental healthcare technologies for anxiety (n=23), depression (n=18), or both anxiety and depression (n=5). Studies of technologies for anxiety evaluated the following: (1) acceptability (78%) reported high levels of satisfaction, (2) adoption (43%) commonly reported positive results, and (3) feasibility (43%) reported mixed results. Studies of technologies for depression evaluated the following: (1) appropriateness (56%) reported moderate helpfulness and (2) acceptability (50%) described a mix of both positive and negative findings. Studies of technologies designed to aid anxiety and depression commonly reported mixed experiences with acceptability and adoption and positive findings for appropriateness of the technologies for treatment. Across all studies, cost, fidelity, and penetration and sustainability were the least measured implementation outcomes. CONCLUSIONS: Acceptability of eMental healthcare technology is high among users and is the most commonly investigated implementation outcome. Perceptions of the appropriateness and adoption of eMental healthcare technology were varied. Implementation research that identifies, evaluates, and reports on costs, sustainability, and fidelity to clinical guidelines is crucial for making high-quality eMental healthcare available to children and adolescents.

When and How Do Brief Alcohol Interventions in Primary Care Reduce Alcohol Use and Alcohol-Related Consequences among Adolescents?

OBJECTIVE: To systematically describe when and how brief alcohol interventions delivered to adolescents in primary care settings reduce alcohol use and alcohol-related consequences among adolescents, using realist review methodology. STUDY DESIGN: Eleven electronic databases, gray literature, and reference screening were searched up to June 2016; 11 brief interventions published in 13 studies met inclusion criteria. Intervention design components (delivery context and intervention mechanisms) underlying brief alcohol interventions for adolescents were extracted and linked to alcohol use and related consequences. RESULTS: Brief interventions had either an indicated context of delivery (provided to adolescent patients with low-to-moderate risk for alcohol problems) or universal context of delivery (provided to general adolescent patient population). Interventions that used motivational interviewing in an indicated delivery context had 2 potential mechanisms-eliciting and strengthening motivation to change and providing direction through interpretation. These interventions resulted in clinically significant reductions in alcohol use and associated consequences. Peer risk also was identified among universal and indicated brief interventions as a potential mechanism for changing alcohol-related outcomes among adolescents who received the intervention. None of the studies tested the processes by which interventions were expected to work. CONCLUSIONS: The current evidence base suggests that both indicated and universal delivery of brief alcohol interventions to adolescents in primary care settings can result in clinically important changes in alcohol-related outcomes. Studies that test brief intervention processes are now necessary to better understand how brief interventions work with adolescents in primary care settings.

The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years.

OBJECTIVES: For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size. STUDY DESIGN: For 300 RCTs, we extracted design and reporting characteristics and assessed RoB. We assessed 5-year changes in design and reporting (based on 300 RCTs we had previously analyzed) using the Fisher exact test. We tested for associations between design and reporting characteristics and overall RoB and registration using the Fisher exact, Cochran-Armitage, Kruskal-Wallis, and Jonckheere-Terpstra tests. We pooled effect sizes and tested for differences by RoB using the χ2 test for subgroups in meta-analysis. RESULTS: The 2012 and 2007 RCTs differed with respect to many design and reporting characteristics. From 2007 to 2012, RoB did not change for random sequence generation and improved for allocation concealment (P < .001). Fewer 2012 RCTs were rated high overall RoB and more were rated unclear (P = .03). Only 7.3% of 2012 RCTs were rated low overall RoB. Trial registration doubled from 2007 to 2012 (23% to 46%) (P < .001) and was associated with lower RoB (P = .009). Effect size did not differ by RoB (P = .43) CONCLUSIONS: Random sequence generation and allocation concealment were not often reported, and selective reporting was prevalent. Measures to increase trialists' awareness and application of existing reporting guidance, and the prospective registration of RCTs is needed to improve the trustworthiness of findings from this field.

Which outcomes are important to patients and families who have experienced paediatric acute respiratory illness? Findings from a mixed methods sequential exploratory study.

OBJECTIVES: To identify the outcome priorities of parents of children who had experienced an acute respiratory infection (ARI). DESIGN: This was a two-phase, mixed methods study with a sequential exploratory design. We used a cross-sectional quantitative web-based survey to elicit parents' priorities for paediatric ARI. We then used a discussion moderated via Facebook to elucidate richer descriptions of parents' priorities. SETTING: Survey and discussion data were collected via the internet. PARTICIPANTS: 110 parents (90% women, median age 35 years, 92.7% urban dwelling, 94.5% with a postsecondary education) with a child who had experienced an ARI responded to the survey. Four parents participated in the Facebook discussion. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was parents' rankings of outcomes related to paediatric ARI. The secondary outcomes were the alignment of parent-reported important outcomes with those commonly reported in Cochrane systematic reviews (SRs). RESULTS: Commonly reported ARIs included croup (44.5%), wheezing (43.6%) and influenza (38.2%). Parents ranked major complications, illness symptoms and length of stay as the most important outcome categories. With respect to specific outcomes, severe complications, major side effects, doctor's assessment, relapse, oxygen supplementation and results from laboratory measures were reported as most important (75th-99th percentile). Taking time off work, mild complications, interference with daily activities, treatment costs, absenteeism, follow-up visits and other costs were deemed minimally important (<25th percentile). In 35 Cochrane SRs, 29 unique outcomes were reported. Although participants' priorities sometimes aligned with outcomes frequently reported in the literature, this was not always true. Additional priorities from the survey (n=50) and Facebook discussions (n=4) included healthcare access, interacting with healthcare providers, education, impact on daily activities and child well-being. CONCLUSIONS: In the context of paediatric ARI, parents' priorities did not always align with commonly researched outcomes. Appealing and efficient strategies to engage patients and parents in research should be developed.