A mixed-methods process evaluation of SafeTea: A multimedia campaign to prevent hot drink scalds in young children and promote burn first aid

Objectives: SafeTea is a multifaceted intervention delivered by community practitioners to prevent hot drink scalds to young children and improve parents’ knowledge of appropriate burn first aid. We adapted SafeTea for a national multimedia campaign, and present a mixed-methods process evaluation of the campaign. Methods: We used social media, a website hosting downloadable materials, and media publicity to disseminate key messages to parents/caregivers of young children and professionals working with these families across the UK. The SafeTea campaign was launched on National Burns Awareness Day (NBAD), October 2019, and ran for three months. Process evaluation measurements included social media metrics, Google Analytics, and quantitative and qualitative results from a survey of professionals who requested hard copies of the materials via the website. Results: Findings were summarised under four themes: “reach”, “engagement”, “acceptability”, and “impact/behaviour change”. The launch on NBAD generated widespread publicity. The campaign reached a greater number of the target audience than anticipated, with over 400,000 views of the SafeTea educational videos. Parents and professionals engaged with SafeTea and expressed positive opinions of the campaign and materials. SafeTea encouraged parents to consider how to change their behaviours to minimise the risks associated with hot drinks. Reach and engagement steadily declined after the first month due to reduced publicity and social media promotion. Conclusion: The SafeTea campaign was successful in terms of reach and engagement. The launch on NBAD was essential for generating media interest. Future campaigns could be shorter, with more funding for additional social media content and promotion

Adherence to prescribed artemisinin-based combination therapy in Garissa and Bunyala districts, Kenya

BACKGROUND: Following the development of resistance to anti-malarial mono-therapies, malaria endemic countries in Africa now use artemisinin-based combination therapy (ACT) as recommended first-line treatment for uncomplicated malaria. Patients' adherence to ACT is an important factor to ensure treatment efficacy, as well as to reduce the likelihood of parasite resistance to these drugs. This study reports adherence to a specific ACT, artemether-lumefantrine (AL), under conditions of routine clinical practice in Kenya. METHOD: The study was undertaken in Garissa and Bunyala districts among outpatients of five government health facilities. Patients treated with AL were visited at home four days after having been prescribed the drug. Respondents (patients ≥ 15 years and caregivers of patients < 15 years) were interviewed using a standardized questionnaire, AL blister packs were physically inspected and the adherence status of patients was then recorded. Multivariate logistic regression modelling was used to determine predictors of adherence. RESULTS: Of the 918 patients included in the study, 588 (64.1%) were 'probably adherent', 291 (31.7%) were 'definitely non-adherent' and 39 (4.2%) were 'probably non-adherent'. Six factors were found to be significant predictors of adherence: patient knowledge of the ACT dosing regimen (odds ratio (OR) = 1.76; 95% CI = 1.32-2.35), patient age (OR = 1.65; 95% CI = 1.02-1.85), respondent age (OR = 1.37; 95% CI = 1.10-2.48), whether a respondent had seen AL before (OR = 1.46; 95% CI = 1.08-1.98), whether a patient had reported dislikes to AL (OR = 0.62 95% CI = 0.47-0.82) and whether a respondent had waited more than 24 hours to seek treatment (OR = 0.73; 95% CI = 0.54-0.99). CONCLUSION: Overall, adherence to AL was found to be low in both Garissa and Bunyala districts, with patient knowledge of the AL dosing regimen found to be the strongest predictor of adherence. Interventions aimed at increasing community awareness of the AL dosing regimen, use of child friendly formulations and improving health workers' prescribing practices are likely to ensure higher adherence to AL and eventual treatment success

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

What proportion of clinical prediction models make it to clinical practice? Protocol for a two-track follow-up study of prediction model development publications

Introduction It is known that only a limited proportion of developed clinical prediction models (CPMs) are implemented and/or used in clinical practice. This may result in a large amount of research waste, even when considering that some CPMs may demonstrate poor performance. Cross-sectional estimates of the numbers of CPMs that have been developed, validated, evaluated for impact or utilized in practice, have been made in specific medical fields, but studies across multiple fields and studies following up the fate of CPMs are lacking. Methods and analysis We have conducted a systematic search for prediction model studies published between January 1995 and December 2020 using the Pubmed and Embase databases, applying a validated search strategy. Taking random samples for every calendar year, abstracts and articles were screened until a target of 100 CPM development studies were identified. Next, we will perform a forward citation search of the resulting CPM development article cohort to identify articles on external validation, impact assessment or implementation of those CPMs. We will also invite the authors of the development studies to complete an online survey to track implementation and clinical utilization of the CPMs. We will conduct a descriptive synthesis of the included studies, using data from the forward citation search and online survey to quantify the proportion of developed models that are validated, assessed for their impact, implemented and/or used in patient care. We will conduct time-to-event analysis using Kaplan-Meier plots. Ethics and dissemination No patient data are involved in the research. Most information will be extracted from published articles. We request written informed consent from the survey respondents. Results will be disseminated through publication in a peer-reviewed journal and presented at international conferences. OSF registration (https://osf.io/nj8s9)

Validation of a Prediction Tool for Abusive Head Trauma.

BACKGROUND AND OBJECTIVES Abusive head trauma (AHT) may be missed in the clinical setting. Clinical prediction tools are used to reduce variability in practice and inform decision-making. From a systematic review and individual patient data analysis we derived the Predicting Abusive Head Trauma (PredAHT) tool, using multilevel logistic regression to predict likelihood of AHT. This study aims to externally validate the PredAHT tool. METHODS Consecutive children aged <36 months admitted with an intracranial injury, confirmed as abusive or nonabusive, to 2 sites used in the original model were ascertained. Details of 6 influential features were recorded (retinal hemorrhage, rib and long -bone fractures, apnea, seizures, and head or neck bruising). We estimated the likelihood of an unrecorded feature being present with multiple imputation; analysis included sensitivity, specificity, and area under the curve, with 95% confidence intervals (CIs). RESULTS Data included 133 non-AHT cases and 65 AHT cases, 97% of children were 81.5% (95% CI, 63.3-91.8). The sensitivity of the tool was 72.3% (95% CI, 60.4-81.7), the specificity was 85.7% (95% CI, 78.8-90.7), area under the curve 0.88 (95% CI, 0.823-0.926). CONCLUSIONS When tested on novel data, the PredAHT tool performed well. This tool has the potential to contribute to decision-making in these challenging cases. An implementation study is needed to explore its performance and utility within the child protection process

Head computed tomography in suspected physical abuse: time to rethink?

Background National guidance recommends CT-head for all children <1 year old with suspected physical abuse, and to be considered for those <2 years old to exclude abusive head trauma. Objectives To investigate whether this guidance is followed, and the associations between clinical presentation and CT findings, to determine whether guidance could be refined. Materials and methods A retrospective case note review of all children <2 years old who underwent medical assessment for suspected abuse (2009–2017). Outcome measures were frequency of CT-head, and diagnostic yield of intracranial injury, skull fracture or both. Results CT-head was undertaken in 60.3% (152/252) of children <12 months old and 7.8% (13/167) of those aged 12–24 months. The diagnostic yield in children who had a CT-head was 27.1% in children <6 months old, 14.3% in those 6–12 months old (p=0.07) and 42.6% (6/13) in those 12–24 months old. For those with head swelling or neurological impairment, it was 84.2% (32/38). In children <12 months old without these clinical features, the estimated prevalence of occult head injury was 6.1% (7/115). The strongest predictors of an abnormal CT-head were swelling to the head (OR 46.7), neurological impairment (OR 20.6) and a low haemoglobin (OR 11.8). Conclusion All children <2 years of age with suspected physical abuse and neurological impairment or head swelling should undergo CT-head. Where the technical skills and the requisite expertise to interpret MRI exist, an MRI scan may be the optimal first-line neuroimaging investigation in infants who are neurologically stable with injuries unrelated to the head to minimise cranial radiation exposure

Effects of the COVID-19 pandemic on the mental health of clinically extremely vulnerable children and children living with clinically extremely vulnerable people in Wales: a data linkage study

Objectives To determine whether clinically extremely vulnerable (CEV) children or children living with a CEV person in Wales were at greater risk of presenting with anxiety or depression in primary or secondary care during the COVID-19 pandemic compared with children in the general population and to compare patterns of anxiety and depression during the pandemic (23 March 2020–31 January 2021, referred to as 2020/2021) and before the pandemic (23 March 2019–31 January 2020, referred to as 2019/2020), between CEV children and the general population.Design Population-based cross-sectional cohort study using anonymised, linked, routinely collected health and administrative data held in the Secure Anonymised Information Linkage Databank. CEV individuals were identified using the COVID-19 shielded patient list.Setting Primary and secondary healthcare settings covering 80% of the population of Wales.Participants Children aged 2–17 in Wales: CEV (3769); living with a CEV person (20 033); or neither (415 009).Primary outcome measure First record of anxiety or depression in primary or secondary healthcare in 2019/2020 and 2020/2021, identified using Read and International Classification of Diseases V.10 codes.Results A Cox regression model adjusted for demographics and history of anxiety or depression revealed that only CEV children were at greater risk of presenting with anxiety or depression during the pandemic compared with the general population (HR=2.27, 95% CI=1.94 to 2.66, p&lt;0.001). Compared with the general population, the risk among CEV children was higher in 2020/2021 (risk ratio 3.04) compared with 2019/2020 (risk ratio 1.90). In 2020/2021, the period prevalence of anxiety or depression increased slightly among CEV children, but declined among the general population.Conclusions Differences in the period prevalence of recorded anxiety or depression in healthcare between CEV children and the general population were largely driven by a reduction in presentations to healthcare services by children in the general population during the pandemic

Current issues and challenges in the definition and operationalization of child maltreatment : A scoping review

Background: Studies show considerable variability in the definitions and operationalization of child maltreatment (CM), which limits research, policy formation, surveillance, and cross-country and cross-sector comparisons.Objective: To review the recent literature (2011-2021) to understand current issues and chal-lenges in defining CM, to assist in the planning, testing and implementing of CM conceptualizations.Methods: We searched eight international databases. Articles were included if the substantive content was related to issues, challenges, and debates in defining CM, and the article was an original study, review, commentary, report, or guideline. The review followed methodological guidance for the conduct of scoping reviews and was reported in accordance with the PRISMA-ScR checklist. Four experts in CM conducted a thematic analysis to summarize findings. Meth-odological rigor of the included studies was not formally assessed. Results: We identified 7372 potentially relevant articles; 55 full-text studies were assessed for eligibility, 25 satisfied the inclusion criteria. We identified three themes: 1) strategies to define CM, including the integration of child and victim perspectives; 2) difficulties in defining specific CM types; and 3) real-world implications for research, prevention and policy.Conclusions: Despite longstanding concerns, challenges regarding the definitions of CM persist. A small minority of studies have tested and implemented CM definitions and operationalizations inpractice. The findings will inform international multi-sectoral processes to develop uniform definitions of CM, for example by highlighting the need to acknowledge challenges in defining some CM types and emphasizing the importance of considering the perspectives of children and CM survivors.Peer reviewe