Development of a novel mobile application, HBB Prompt, with human factors and user-centred design for Helping Babies Breathe skills retention in Uganda.

BACKGROUND: Helping Babies Breathe (HBB) is a life-saving program that has helped reduce neonatal morbidity and mortality, but knowledge and skills retention after training remains a significant challenge for sustainability of impact. User-centred design (UCD) can be used to develop solutions to target knowledge and skills maintenance. METHODS: We applied a process of UCD beginning with understanding the facilitators of, and barriers to, learning and retaining HBB knowledge and skills. HBB Master Trainers and frontline HBB providers participated in a series of focus group discussions (FGDs) to uncover the processes of skills acquisition and maintenance to develop a mobile application called "HBB Prompt". Themes derived from each FGD were identified and implications for development of the HBB Prompt app were explored, including feasibility of incorporating strategies into the format of an app. Data analysis took place after each iteration in Phase 1 to incorporate feedback and improve subsequent versions of HBB Prompt. RESULTS: Six HBB trainers and seven frontline HBB providers participated in a series of FGDs in Phase 1 of this study. Common themes included lack of motivation to practise, improving confidence in ventilation skills, ability to achieve the Golden Minute, fear of forgetting knowledge or skills, importance of feedback, and peer-to-peer learning. Themes identified that were not feasible to address pertained to health system challenges. Feedback about HBB Prompt was generally positive. Based on initial and iterative feedback, HBB Prompt was created with four primary functions: Training Mode, Simulation Mode, Quizzes, and Dashboard/Scoreboard. CONCLUSIONS: Developing HBB Prompt with UCD to help improve knowledge and skills retention was feasible and revealed key concepts, including drivers for successes and challenges faced for learning and maintaining HBB skills. HBB Prompt will be piloted in Phase 2 of this study, where knowledge and skills retention after HBB training will be compared between an intervention group with HBB Prompt and a control group without the app. Trial registration Clinicaltrials.gov (NCT03577054). Retrospectively registered July 5, 2018, https://clinicaltrials.gov/ct2/show/study/NCT03577054 .

Comparative safety of anti-epileptic drugs during pregnancy: a systematic review and network meta-analysis of congenital malformations and prenatal outcomes.

BACKGROUND: Pregnant women with epilepsy frequently experience seizures related to pregnancy complications and are often prescribed anti-epileptic drugs (AEDs) to manage their symptoms. However, less is known about the comparative safety of AED exposure in utero. We aimed to compare the risk of congenital malformations (CMs) and prenatal outcomes of AEDs in infants/children who were exposed to AEDs in utero through a systematic review and Bayesian random-effects network meta-analysis. METHODS: MEDLINE, EMBASE, and Cochrane CENTRAL were searched from inception to December 15, 2015. Two reviewers independently screened titles/abstracts and full-text papers for experimental and observational studies comparing mono- or poly-therapy AEDs versus control (no AED exposure) or other AEDs, then abstracted data and appraised the risk of bias. The primary outcome was incidence of major CMs, overall and by specific type (cardiac malformations, hypospadias, cleft lip and/or palate, club foot, inguinal hernia, and undescended testes). RESULTS: After screening 5305 titles and abstracts, 642 potentially relevant full-text articles, and 17 studies from scanning reference lists, 96 studies were eligible (n = 58,461 patients). Across all major CMs, many AEDs were associated with higher risk compared to control. For major CMs, ethosuximide (OR, 3.04; 95% CrI, 1.23-7.07), valproate (OR, 2.93; 95% CrI, 2.36-3.69), topiramate (OR, 1.90; 95% CrI, 1.17-2.97), phenobarbital (OR, 1.83; 95% CrI, 1.35-2.47), phenytoin (OR, 1.67; 95% CrI, 1.30-2.17), carbamazepine (OR, 1.37; 95% CrI, 1.10-1.71), and 11 polytherapies were significantly more harmful than control, but lamotrigine (OR, 0.96; 95% CrI, 0.72-1.25) and levetiracetam (OR, 0.72; 95% CrI, 0.43-1.16) were not. CONCLUSION: The newer generation AEDs, lamotrigine and levetiracetam, were not associated with significant increased risks of CMs compared to control, and were significantly less likely to be associated with children experiencing cardiac malformations than control. However, this does not mean that these agents are not harmful to infants/children exposed in utero. Counselling is advised concerning teratogenic risks when the prescription is written for a woman of childbearing age and before women continue with these agents when considering pregnancy, such as switching from polytherapy to monotherapy with evidence of lower risk and avoiding AEDs, such as valproate, that are consistently associated with CMs. These decisions must be balanced against the need for seizure control. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014008925.

Utilization of a novel mobile application, "HBB Prompt", to reduce Helping Babies Breathe skills decay.

BACKGROUND: Helping Babies Breathe (HBB) is a newborn resuscitation training program designed to reduce neonatal mortality in low- and middle-income countries. However, skills decay after initial training is a significant barrier to sustained impact. OBJECTIVE: To test whether a mobile app, HBB Prompt, developed with user-centred design, helps improve skills and knowledge retention after HBB training. METHODS: HBB Prompt was created during Phase 1 of this study with input from HBB facilitators and providers from Southwestern Uganda recruited from a national HBB provider registry. During Phase 2, healthcare workers (HCWs) in two community hospitals received HBB training. One hospital was randomly assigned as the intervention hospital, where trained HCWs had access to HBB Prompt, and the other served as control without HBB Prompt (NCT03577054). Participants were evaluated using the HBB 2.0 knowledge check and Objective Structured Clinical Exam, version B (OSCE B) immediately before and after training, and 6 months post-training. The primary outcome was difference in OSCE B scores immediately after training and 6 months post-training. RESULTS: Twenty-nine HCWs were trained in HBB (17 in intervention, 12 in control). At 6 months, 10 HCW were evaluated in intervention and 7 in control. In intervention and control respectively, the median OSCE B scores were: 7 vs. 9 immediately before training, 17 vs. 21 immediately after training, and 12 vs. 13 at 6 months after training. Six months after training, the median difference in OSCE B scores was -3 (IQR -5 to -1) in intervention and -8 (IQR -11 to -6) in control (p = 0.02). CONCLUSION: HBB Prompt, a mobile app created by user-centred design, improved retention of HBB skills at 6 months. However, skills decay remained high 6 months after training. Continued adaptation of HBB Prompt may further improve maintenance of HBB skills.

Designing and evaluating a novel mobile application for Helping Babies Breathe skills retention in Uganda: comparative study protocol.

INTRODUCTION: Over 600 000 newborns die each year of intrapartum-related events, many of which are preventable in the presence of skilled birth attendants. Helping Babies Breathe (HBB) is a neonatal resuscitation training programme designed for low-resource settings that can reduce both early neonatal mortality and stillbirths. However, as in other similar educational programmes, knowledge and skill retention deteriorate over time. This trend may be counteracted by strategies such as regular simulated exercises. In this study, a mobile application (app) 'HBB Prompt' will be developed to assist providers in retaining HBB knowledge and skills. METHODS AND ANALYSIS: This is a comparative study in Uganda with two phases: an app development phase and an assessment phase. In the first phase, HBB trainers and providers will explore barriers and facilitators to enhance learning and maintenance of HBB skills and knowledge through focus group discussions (FGDs). The FGDs are designed with a human factors perspective, enabling collection of relevant data for the prototype version of HBB Prompt. The app will then undergo usability and feasibility testing through FGDs and simulations. In the second phase, a minimum of 10 healthcare workers from two district hospitals will receive HBB training. Only the intervention hospital will have access to HBB Prompt. All participants will be asked to practise HBB skills every shift and record this in a logbook. In the intervention site, app usage data will also be collected. The primary outcome will be comparing skills retention 12 months after training, as determined by Objective Structured Clinical Examination B scores. ETHICS AND DISSEMINATION: This study received ethics approval from The Hospital for Sick Children and Mbarara University of Science and Technology. The authors plan to publish all relevant findings from this study in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03577054.

Comparative safety of antiepileptic drugs for neurological development in children exposed during pregnancy and breast feeding: a systematic review and network meta-analysis.

OBJECTIVES: Compare the safety of antiepileptic drugs (AEDs) on neurodevelopment of infants/children exposed in utero or during breast feeding. DESIGN AND SETTING: Systematic review and Bayesian random-effects network meta-analysis (NMA). MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched until 27 April 2017. Screening, data abstraction and quality appraisal were completed in duplicate by independent reviewers. PARTICIPANTS: 29 cohort studies including 5100 infants/children. INTERVENTIONS: Monotherapy and polytherapy AEDs including first-generation (carbamazepine, clobazam, clonazepam, ethosuximide, phenobarbital, phenytoin, primidone, valproate) and newer-generation (gabapentin, lamotrigine, levetiracetam, oxcarbazepine, topiramate, vigabatrin) AEDs. Epileptic women who did not receive AEDs during pregnancy or breast feeding served as the control group. PRIMARY AND SECONDARY OUTCOME MEASURES: Cognitive developmental delay and autism/dyspraxia were primary outcomes. Attention-deficit hyperactivity disorder, language delay, neonatal seizures, psychomotor developmental delay and social impairment were secondary outcomes. RESULTS: The NMA on cognitive developmental delay (11 cohort studies, 933 children, 18 treatments) suggested that among all AEDs only valproate was statistically significantly associated with more children experiencing cognitive developmental delay compared with control (OR=7.40, 95% credible interval (CrI) 3.00 to 18.46). The NMA on autism (5 cohort studies, 2551 children, 12 treatments) suggested that oxcarbazepine (OR 13.51, CrI 1.28 to 221.40), valproate (OR 17.29, 95% CrI 2.40 to 217.60), lamotrigine (OR 8.88, CrI 1.28 to 112.00) and lamotrigine+valproate (OR 132.70, CrI 7.41 to 3851.00) were associated with significantly greater odds of developing autism compared with control. The NMA on psychomotor developmental delay (11 cohort studies, 1145 children, 18 treatments) found that valproate (OR 4.16, CrI 2.04 to 8.75) and carbamazepine+phenobarbital+valproate (OR 19.12, CrI 1.49 to 337.50) were associated with significantly greater odds of psychomotor delay compared with control. CONCLUSIONS: Valproate alone or combined with another AED is associated with the greatest odds of adverse neurodevelopmental outcomes compared with control. Oxcarbazepine and lamotrigine were associated with increased occurrence of autism. Counselling is advised for women considering pregnancy to tailor the safest regimen. TRIAL REGISTRATION NUMBER: PROSPERO database (CRD42014008925).