Development of the key performance indicators for digital health interventions: A scoping review.

Background: Digital health interventions offer new methods for delivering healthcare, with the potential to innovate healthcare services. Key performance indicators play a role in the evaluation, measurement, and improvement in healthcare quality and service performance. The aim of this scoping review was to identify current knowledge and evidence surrounding the development of key performance indicators for digital health interventions. Methods: A literature search was conducted across ten key databases: AMED - The Allied and Complementary Medicine Database, CINAHL - Complete, Health Source: Nursing/Academic Edition, MEDLINE, APA PsycINFO, EMBASE, EBM Reviews - Cochrane Database of Systematic Reviews, EBM Reviews - Database of Abstracts of Reviews of Effects, EBM Reviews - Health Technology Assessment, and IEEE Xplore. Results: Five references were eligible for the review. Two were articles on original research studies of a specific digital health intervention, and two were overviews of methods for developing digital health interventions (not specific to a single digital health intervention). All the included reports discussed the involvement of stakeholders in developing key performance indicators for digital health interventions. The step of identifying and defining the key performance indicators was completed using various methodologies, but all centred on a form of stakeholder involvement. Potential options for stakeholder involvement for key performance indicator identification include the use of an elicitation framework, a factorial survey approach, or a Delphi study. Conclusions: Few articles were identified, highlighting a significant gap in evidence-based knowledge in this domain. All the included articles discussed the involvement of stakeholders in developing key performance indicators for digital health interventions, which were performed using various methodologies. The articles acknowledged a lack of literature related to key performance indicator development for digital health interventions. To allow comparability between key performance indicator initiatives and facilitate work in the field, further research would be beneficial to develop a common methodology for key performance indicators development for digital health interventions.

Needs assessment of parents for a patient decision aid in pediatric interval appendectomy via the qualitative interview method.

Objectives: Appendicitis is one of the most commonly encountered pediatric surgical diagnoses, with non-operative management of perforated appendicitis leading to two treatment options: an interval appendectomy (IA) or expectant management. The primary objective of this study was to assess parents' need for a patient decision aid (PDA) among parents considering IA or expectant management. A secondary objective was to determine parent preferences for the format and distribution plan of a drafted patient decision aid. Methods: Coulter's systematic development process for PDA was used to guide the assessment interviews for parents. Participants included caregivers of a patient who experienced perforated appendicitis, and admission between 2019 and 2020. Semi-structured individual interviews were conducted to collect information about decision-making needs of parents of children who experienced perforated appendicitis. Results: A total of 12 different parents participated in the interviews. Results indicate decisional conflict associated with the lack of evidence for optimal treatment, supporting the need for the development of a patient decision aid to assist in clarifying information and parent values with practitioners. Parents clearly identified a need for evidence to support decision-making in various formats (eg, pamphlet or electronic). Timing of when to deliver the PDA varied (ie, during hospital admission, at discharge, or at follow-up appointment). Conclusion: Results indicated various factors contributing to parental decisional conflict, including the lack of evidence showing the optimal treatment, the need for more information, and guidance from practitioners. Overall, findings indicate a strong need for a patient decision aid.

Peri-Operative Liver Fibrosis and Native Liver Survival in Pediatric Patients with Biliary Atresia: A Systematic Review and Meta-Analysis.

No systematic review to date has examined histopathological parameters in relation to native liver survival in children who undergo the Kasai operation for biliary atresia (BA). A systematic review and meta-analysis is presented, comparing the frequency of native liver survival in peri-operative severe vs. non-severe liver fibrosis cases, in addition to other reported histopathology parameters. Records were sourced from MEDLINE, Embase, and CENTRAL databases. Studies followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and compared native liver survival frequencies in pediatric patients with evidence of severe vs. non-severe liver fibrosis, bile duct proliferation, cholestasis, lobular inflammation, portal inflammation, and giant cell transformation on peri-operative biopsies. The primary outcome was the frequency of native liver survival. A random effects meta-analysis was used. Twenty-eight observational studies were included, 1,171 pediatric patients with BA of whom 631 survived with their native liver. Lower odds of native liver survival in the severe liver fibrosis vs. non-severe liver fibrosis groups were reported (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.08-0.33; I2 =46%). No difference in the odds of native liver survival in the severe bile duct destruction vs. non-severe bile duct destruction groups were reported (OR, 0.17; 95% CI, 0.00-63.63; I2 =96%). Lower odds of native liver survival were documented in the severe cholestasis vs. non-severe cholestasis (OR, 0.10; 95% CI, 0.01-0.73; I2 =80%) and severe lobular inflammation vs. non-severe lobular inflammation groups (OR, 0.02; 95% CI, 0.00-0.62; I2 =69%). There was no difference in the odds of native liver survival in the severe portal inflammation vs. non-severe portal inflammation groups (OR, 0.03; 95% CI, 0.00-3.22; I2 =86%) or between the severe giant cell transformation vs. non-severe giant cell transformation groups (OR, 0.15; 95% CI, 0.00-175.21; I2 =94%). The meta-analysis loosely suggests that the presence of severe liver fibrosis, cholestasis, and lobular inflammation are associated with lower odds of native liver survival in pediatric patients after Kasai.

Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool.

BACKGROUND: Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. METHODS: The study employed the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool. RESULTS: The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) 'Identify and prepare champions', (2) 'Conduct local needs assessment', (3) 'Conduct educational meetings', (4) 'Inform local opinion leaders', (5) 'Build a coalition', (6) 'Promote adaptability', (7) 'Develop a formal implementation blueprint', (8) 'Involve patients/consumers and family members', (9) 'Obtain and use patients/consumers and family feedback', (10) 'Develop educational materials', (11) 'Promote network weaving', (12) 'Distribute educational materials', (13) 'Access new funding' and (14) 'Develop academic partnerships'. CONCLUSION: This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.

Diagnostic Value of Mid-esophageal Biopsies in Pediatric Patients With Eosinophilic Esophagitis.

INTRODUCTION: Eosinophilic esophagitis (EoE) is histologically defined as the presence of 15 or more intraepithelial eosinophils per high-power fields. Limited consensus exists on where to sample the esophagus in pediatrics. This study aimed to identify whether endoscopic and histologic examination of the mid esophagus offers diagnostic value compared to proximal/distal esophageal biopsies. METHODS: A retrospective chart review of pediatric patients with EoE was performed. Endoscopic and histologic parameters were assessed at the initial and follow-up visits, and concordance between proximal/distal biopsy and mid biopsy was determined. RESULTS: A total of 100 patients with a mean age of 9.6 ± 4.07 years were included. Endoscopic parameters between proximal/distal and mid esophagus were concordant in 84% to 97% of patients (initial assessment) and in 80% to 97% of patients (at follow-up). Mid esophagus showed endoscopic abnormalities, which were absent at the proximal/distal esophagus in 1% to 5% of patients, as well as histologic abnormalities in 2% to 8% of patients overall at initial and follow-up examinations. CONCLUSIONS: We recommend continued endoscopic and histologic assessment of the proximal/distal biopsy; however, examination of the mid esophagus does offer small diagnostic value in our subset of patients. Future studies need to be conducted before conclusive recommendations supporting the use of mid-esophageal biopsies can be made.

Predictors of spontaneous resolution of umbilical hernia in children.

Objective: The aims were to describe the management of umbilical hernias, to define postoperative complications, and to identify the characteristics of patients that were more likely to have spontaneous resolution of their hernia. Methods: All patients referred for umbilical hernia at the Children's Hospital of Eastern Ontario from January 1990 to April 2017 were examined via retrospective chart review. Spontaneous resolution of umbilical hernia was examined using binary logistic regression. Results: We included 2621 patients presenting with an umbilical hernia. A total of 1587 (60.5%) patients underwent surgical repair at a median age of 3.6 years (IQR 2.3-5.4). Surgical complications consisted of infection (n=3), bleeding (n=3), hematoma (n=3), and anesthesia-related complications (n=3). For every one-unit increase in defect size, the odds of a spontaneous resolution of the hernia were 5% lower while controlling for prematurity and the presence of comorbidities [adjusted odds ratio (aOR)=0.95; 95% confidence intervel (CI) 0.93 to 0.97]. Premature babies were 80% less likely to experience hernia resolution compared with non-premature babies (aOR=0.20; 95% CI 0.03 to 0.74). Conclusion: The odds of spontaneous resolution were lower for premature babies and were negatively correlated with defect size.

Barriers and enablers to conducting cluster randomized control trials in hospitals: A theory-informed scoping review.

BACKGROUND: Cluster randomized control trials (cRCTs) have unique challenges compared to single site trials with regards to conduct of the trial, and it is important to understand these barriers. The aim of this scoping review was to describe the current literature surrounding the implementation of the cRCTs in hospitals. METHODS: The search strategy was designed to identify literature relevant to conduct of cRCTs, with hospitals as the unit of randomization. Data was extracted and was mapped using the Consolidated Framework for Implementation Research (CFIR) as a codebook, which contains 39 constructs organized into five domains. RESULTS: Twenty-two articles met inclusion criteria and were included. 18 of 39 constructs of the CFIR were identified in coding, spanning four of the five domains. Barriers to the conduct of the trial were rarely reported as the main outcome of the study, and few details were included in the identified literature. CONCLUSIONS: The review can provide guidance to future researchers planning cRCTs in hospitals. It also identified a large gap in reporting of conduct of these trials, demonstrating the need for a research agenda that further explores the barriers and facilitators, with the aim of garnering knowledge for improved guidance in the implementation.

Tube cecostomy versus appendicostomy for antegrade enemas in the management of fecal incontinence in children: A systematic review.

BACKGROUND: Few studies have directly compared between cecostomy and appendicostomy for the management of fecal incontinence in pediatric population. This systematic review of the literature describes outcomes and complications following both procedures. We also reviewed studies reporting impact on quality of life and patient satisfaction. METHODS: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar were searched for chronic constipation pediatric patients who underwent cecostomy or appendicostomy. Two reviewers independently screened studies, extracted data, and assessed quality. RESULTS: An initial literature search retrieved 633 citations. After review of all abstracts, 40 studies were included in the final analysis, assessing a total of 2086 patients. The overall rate of complications was lower in the cecostomy group compared to the appendicostomy group (16.6% and 42.3%, respectively). Achievement of fecal continence and improvement in patient quality of life were found to be similar in both groups, however the need for revision of surgery was approximately 15% higher in the appendicostomy group. CONCLUSION: Cecostomy has less post procedural complications, however rates of patient satisfaction and impact on quality of life were similar following both procedures. LEVEL OF EVIDENCE: III.

Risk of Lower Birth Weight and Shorter Gestation in Oocyte Donation Pregnancies Compared With Other Assisted Reproductive Technology Methods: Systematic Review.

OBJECTIVE: Oocyte donation (OD) is associated with an increased risk of pregnancy-induced hypertension, but the evidence of an association between OD and infant outcomes, including birth weight and gestational age, is conflicting. This study sought to determine the associations between oocyte donation and birth weight or gestational age compared with other forms of autologous oocyte assisted reproductive technology (ART). METHODS: Medline, Embase, and the CENTRAL Trials Registry of the Cochrane Collaboration were searched using a comprehensive search strategy. Studies of women over 24 weeks gestation compared infant outcomes among OD pregnancies versus other ART. Study quality was assessed, and a meta-analysis of mean birth weight and gestational age was conducted using a random effects model. RESULTS: Nineteen studies were included. Four studies showed a significant association between OD and lower birth weights, and five studies found significant differences in gestational age between OD and autologous oocyte ART. The pooled difference in birth weight means between OD and autologous ART was -42 (-88, 4) . The pooled difference in gestational age was -0.4 weeks (-0.8, 0.0 weeks). CONCLUSION: A high degree of interstudy heterogeneity exists, and the association between OD and infant outcomes remains unclear.

Coping strategies and self-esteem in the high-risk offspring of bipolar parents.

OBJECTIVES: This study investigated whether there were differences in coping strategies and self-esteem between offspring of parents with bipolar disorder (high-risk) and offspring of unaffected parents (control), and whether these psychological factors predicted the onset and recurrence of mood episodes. METHODS: High-risk and control offspring were followed longitudinally as part of the Flourish Canadian high-risk bipolar offspring cohort study. Offspring were clinically assessed annually by a psychiatrist using semi-structured interviews and completed a measure of coping strategies and self-esteem. RESULTS: In high-risk offspring, avoidant coping strategies significantly increased the hazard of a new onset Diagnostic and Statistical Manual of Mental Disorders, 4th Edition twice revised mood episode or recurrence (hazard ratio: 1.89, p = 0.04), while higher self-esteem significantly decreased this hazard (hazard ratio: 2.50, p < 0.01). Self-esteem and avoidant coping significantly interacted with one another ( p < 0.05), where the risk of a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition twice revised new onset mood episode or recurrence was only significantly increased among high-risk offspring with both high avoidant coping and low self-esteem. CONCLUSION: A reduction of avoidant coping strategies in response to stress and improvement of self-esteem may be useful intervention targets for preventing the new onset or recurrence of a clinically significant mood disorder among individuals at high familial risk.

Daily and weekly mood ratings using a remote capture method in high-risk offspring of bipolar parents: Compliance and symptom monitoring.

OBJECTIVES: To determine the compliance and clinical utility of weekly and daily electronic mood symptom monitoring in adolescents and young adults at risk for mood disorder. METHODS: Fifty emerging adult offspring of bipolar parents were recruited from the Flourish Canadian high-risk offspring cohort study along with 108 university student controls. Participants were assessed by KSADS/SADS-L semi-structured interviews and used a remote capture method to complete weekly and daily mood symptom ratings using validated scales for 90 consecutive days. Hazard models and generalized estimating equations were used to determine differences in summary scores and regularity of ratings. RESULTS: Seventy-eight and 77% of high-risk offspring and 97% and 93% of controls completed the first 30 days of weekly and daily ratings, respectively. There were no differences in drop-out rates between groups over 90 days (weekly P = 0.2149; daily P = 0.9792). There were no differences in mean summary scores or regularity of weekly anxiety, depressive or hypomanic symptom ratings between high-risk offspring and control groups. However, high-risk offspring compared to controls had daily ratings indicating lower positive affect, higher negative affect and lower self-esteem (P = 0.0317). High-risk offspring with remitted mood disorder compared to those without had more irregularity in weekly anxiety and depressive symptom ratings and daily ratings of lower positive affect, higher negative affect, and higher shame and self-doubt (P = 0.0365). CONCLUSIONS: Findings support that high-resolution electronic mood tracking may be a feasible and clinically useful approach in monitoring emerging psychopathology in young people at high-risk offspring of mood disorder onset or recurrence.

Efficacy and tolerability of lithium for the treatment of acute mania in children with bipolar disorder: A systematic review: A report from the ISBD-IGSLi joint task force on lithium treatment.

OBJECTIVES: To assess the efficacy and tolerability of lithium for the treatment of acute mania in children and adolescent diagnosed with bipolar disorder. METHODS: A systematic literature search up to August 2017 was conducted for clinical trials that included lithium in males and females up to 18 years of age with a diagnosis of bipolar disorder and experiencing a manic or mixed episode according to standardized diagnostic criteria. The protocol was registered in PROSPERO (CRD42017055675). RESULTS: Four independent studies described in seven manuscripts met the inclusion criteria. Overall, 176 patients were treated with lithium either as a monotherapy or adjunct to risperidone. Efficacy results suggest that lithium may be superior to placebo (standardized mean difference [SMD] -0.42, 95% confidence interval [CI] -0.88 to 0.04), comparable to sodium divalproex (SMD -0.07, 95% CI: -0.31 to 0.18), but significantly less effective than risperidone for treating protracted manic/mixed episodes and comorbid attention-deficit hyperactivity disorder (ADHD) in prepubertal children (SMD 0.85, 95% CI: 0.54 to 1.15). Lithium was not associated with serious adverse events, and was generally well tolerated with common side effects similar to those reported in adults. CONCLUSIONS: Limited data suggests that lithium may be an effective and tolerable treatment for some forms of paediatric mania. However, lithium is clearly inferior in efficacy to risperidone in prepubertal patients diagnosed with protracted manic/mixed episodes and comorbid ADHD. There is a lack of data concerning the efficacy and tolerability of lithium as an acute treatment for classical mania in adolescents and important clinical issues remain unaddressed.