Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol.

INTRODUCTION: The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature. METHODS AND ANALYSIS: The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis. ETHICS AND DISSEMINATION: This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC. STUDY REGISTRATION: Open Science Framework (https://osf.io/k72bn).

Cost-effectiveness analysis of individual-level obesity treatment in paediatrics: A scoping review.

OBJECTIVES: This scoping review informs a health economics perspective on the treatment of paediatric obesity. The results detail recently published research findings on the cost-effectiveness of paediatric obesity treatments and identify key characteristics of cost-effective interventions. METHODS: A structured search was applied to six databases with no data restriction through March 2023: Medline, Embase, Cochrane CENTRAL, CINAHL, and PsycINFO. Studies that included a cost analysis of an individual level, weight management intervention (behavioural, pharmacotherapy, and surgical) in youth, with obesity, ages 2 to 21 years were eligible for inclusion. RESULTS: Of the 4371 records identified in the initial search, 353 underwent full-text review, 39 studies met the pre-specified inclusion criteria. The majority were published after 2010 (n = 36/39, 92%) and applied to high-income countries (n = 39/39, 100%). Thirty-five of the studies assessed the cost-effectiveness of lifestyle interventions (90%), and four studies assessed surgical outcomes (10%). No pharmacotherapy studies met eligibility criteria. Although the outcome measures differed across the studies, all four surgical interventions were reported to be cost-effective. Thirty of the 35 (85%) lifestyle modification studies were reported to be cost-effective compared to the study comparator examined. CONCLUSIONS: There is a small amount of evidence that individual-level paediatric obesity treatment interventions are cost-effective and, in some cases cost-saving, with most of this work conducted on behavioural interventions. The economic evaluation of paediatric obesity interventions poses various methodologic challenges, which should be addressed in future research to fully use the potential of economic evaluation as an aid to decision-making.

Role of artificial intelligence in imaging and endoscopy for the diagnosis, monitoring and prognostication of inflammatory bowel disease: a scoping review protocol.

INTRODUCTION: Inflammatory bowel diseases (IBD) are immune-mediated conditions that are increasing in incidence and prevalence worldwide. Their assessment and monitoring are becoming increasingly important, though complex. The best disease control is achieved through tight monitoring of objective inflammatory parameters (such as serum and stool inflammatory markers), cross-sectional imaging and endoscopic assessment. Considering the complexity of the information obtained throughout a patient's journey, artificial intelligence (AI) provides an ideal adjunct to existing tools to help diagnose, monitor and predict the course of disease of patients with IBD. Therefore, we propose a scoping review assessing AI's role in diagnosis, monitoring and prognostication tools in patients with IBD. We aim to detect gaps in the literature and address them in future research endeavours. METHODS AND ANALYSIS: We will search electronic databases, including Medline, Embase, Cochrane CENTRAL, CINAHL Complete, Web of Science and IEEE Xplore. Two reviewers will independently screen the abstracts and titles first and then perform the full-text review. A third reviewer will resolve any conflict. We will include both observational studies and clinical trials. Study characteristics will be extracted using a data extraction form. The extracted data will be summarised in a tabular format, following the imaging modality theme and the study outcome assessed. The results will have an accompanying narrative review. ETHICS AND DISSEMINATION: Considering the nature of the project, ethical review by an institutional review board is not required. The data will be presented at academic conferences, and the final product will be published in a peer-reviewed journal.

Sonographic reference values for median nerve cross-sectional area: A meta-analysis of data from healthy individuals.

Objective: Establish median nerve CSA reference values and identify patient-level factors impacting diagnostic thresholds. Methods: Studies were identified through a robust search of multiple databases, and quality assessment was conducted using a modified version of the National Institute of Health Study Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. A meta-analysis was performed to identify normative values stratified by anatomic location. A meta-regression was conducted to examine heterogeneity effects of age, sex, and laterality. Results: The meta-analysis included 73 studies; 41 (56.2%) were high quality. The median nerve CSA [95% CI] was 6.46mm2 [6.09-6.84], 8.68mm2 [8.22-9.13], and 8.60mm2 [8.23-8.97] at the proximal forearm, the carpal tunnel inlet, and the proximal carpal tunnel, respectively. Age was positively associated with CSA at the level of proximal carpal tunnel (ß=0.03mm2, p=0.047). Men (9.42mm2, [8.06-10.78]) had statistically larger proximal tunnel CSA (p = 0.03) as compared to women (7.71mm2, [7.01-8.42]). No difference was noted in laterality. Conclusion: A reference value for median nerve CSA in the carpal tunnel is 8.60mm2. Adjustments may be required in pediatrics or older adults. The diagnostic threshold of 10.0mm2 for male patients should be cautiously applied as the upper limit of normative averages surpasses this threshold.

Mobile applications to support parents in the transition from neonatal intensive care unit to home: a narrative review.

Background and Objective: Among the unique challenges for parents in the transition of infant care from neonatal intensive care unit (NICU) to home are the medical complexity of their babies and the psychological burden of caring for this special patient population. Despite the increased use and accessibility of smartphones, mobile applications (apps) intended for use by families during this transition remain underdeveloped and understudied. Apps to support parents of infants in the NICU represent an accessible potential solution to mitigate existing disparities in follow up. Through this Narrative Review, we intend to describe the characteristics of and development process for apps intended to address the challenges parents with NICU babies may face, and to provide recommendations for further development of apps for this purpose. Methods: We conducted a review of articles published between November 2012 to November 2022. This search spanned three major databases, PubMed, Embase, and CINAHL, using a controlled vocabulary and keywords for mobile apps and the NICU. These three databases generated 473 articles for review. Utilizing the online primary screening and data extraction tool Covidence, we ultimately included eight articles in this narrative review. Key Content and Findings: There are few existing mobile apps intended to ease the transition home for parents of babies in the NICU. There are even fewer apps that have been critically evaluated using acceptable methods and produced with contribution from healthcare practitioners. Among the existing articles on app solutions to benefit education and socioemotional support for parents, many emphasized the importance of including key stakeholders during the app development process and highlighted both qualitative and quantitative measures for assessing relative success of these apps in a clinical setting. Conclusions: Although the experiences of parents with infants admitted to the NICU have been well-studied, there remain relatively few existing apps to provide educational and socioemotional support to this population. Future studies should focus on an iterative process of app development whereby both parents and providers are closely involved, in combination with critical appraisal of the app to assess for appropriate support and education of caregivers.

Health Informatics Training Program in Low and Middle Income Countries.

We developed the first health informatics training program in Armenia and in the Caucasus region. The training program consists of four educational pillars, including a bootcamp, an individualized training program, a capstone, and a scholarly project. We conducted surveys and qualitative interviews to evaluate the training program. With trending positive results we acknowledge that it is important to understand the landscape of health informatics and conduct needs assessment prior to establishing such a training program in an LMIC.

Informing the Physical Therapy Management of Congenital Muscular Torticollis Clinical Practice Guideline: A Systematic Review.

PURPOSE: To systematically review current evidence on the physical therapy assessment, intervention, and prognosis of congenital muscular torticollis (CMT) to inform the update to the 2018 CMT Clinical Practice Guideline (CPG). METHODS: Six databases were searched for studies that informed assessment, intervention, and prognosis for physical therapy management of infants with CMT. RESULTS: Fifteen studies were included. Four studies investigated the psychometric properties of new and established assessments. Six studies informed the feasibility and efficacy of first-choice and supplemental interventions including traditional Chinese medicine and neural and visceral manipulation. One qualitative study found that parents of infants with mild and severe CMT had different concerns. Five studies informed prognosis, including factors associated with treatment duration, clinical outcomes, and use of supplemental interventions. CONCLUSION: Newer evidence reaffirms 5 of 17 recommendations of the 2018 CMT CPG and could increase the recommendation strength to strong for neck passive range of motion.

The integration of primary care and childhood cancer survivorship care: a scoping review.

PURPOSE: This scoping review describes existing care models that integrate primary care and childhood cancer survivorship care, examines the effectiveness of these models, and characterizes barriers and facilitators to their integration. METHODS: A systematic search (PubMed®, CINAHL®, Embase®) was conducted to identify citations which were evaluated against inclusion criteria using the PICOTTS framework. The PRISMA-ScR extension for scoping reviews was used to report review findings (protocol https://osf.io/92xbg ). RESULTS: Twenty-three studies were included. Three care models integrating primary care and childhood cancer survivorship care were identified: consultative shared care in a primary care setting (N = 3); longitudinal shared care (N = 2); and PCP-led care employing a survivorship care plan (N = 5). While many described risk-adapted care, few used risk stratification approaches to inform care. Measures of model effectiveness varied, with discrepant findings regarding late effects detection in PCP-led approaches. The most frequently cited barriers and facilitators reflected provider- and system-level factors (PCP knowledge/experience identified as greatest barrier (N = 11); clinical information from oncologist identified as greatest facilitator (N = 9)). CONCLUSIONS: Identified models depended on PCP knowledge and healthcare system coordination, and studies suggested the need for strong oncologic involvement in follow-up care. Improved training for PCPs and the coordinated transfer of clinical information could facilitate their involvement in such care. Overall, standardized measures of effectiveness are needed to deliver optimal childhood cancer survivorship care. IMPLICATIONS FOR CANCER SURVIVORS: The literature revealed three care models defined by SCP use, provider involvement, and continuity of care, with several studies recommending oncologic involvement in follow-up care for high-risk survivors.

International Collaboration to Develop a Remote Monitoring Web App for COVID-19 Patients in Armenia: Design and Development With Agile Methodology.

BACKGROUND: COVID-19 has led to over 500 million cases and 6.2 million deaths around the world. Low- and middle-income countries (LMICs) like Armenia face unique infrastructure, financial, and capacity challenges that in many cases result in worse outcomes. Health care facilities across Armenia experienced a shortage of resources, including hospital beds and oxygen, which was further exacerbated by the war with neighboring Azerbaijan. Without a framework for home-based care, health care facilities were severely strained by COVID-19 patients who had prolonged oxygen requirements but were otherwise clinically stable. OBJECTIVE: This paper describes our approach to establishing an international collaboration to develop a web app to support home monitoring of patients with COVID-19 with persistent oxygen requirements. METHODS: The app was developed using a rapid, coordinated, and collaborative approach involving an international group of clinicians, developers, and collaborators. Health screening, monitoring, and discharge forms were developed into a lightweight OpenMRS web app and customized for the local Armenian context. RESULTS: The software was designed and developed over 2 months using human-centered design and agile sprints. Once live, 5087 patient records were created for 439 unique patients. CONCLUSIONS: This project suggests a promising framework for designing and implementing remote monitoring programs in LMICs, despite pandemic and geopolitical challenges.

Geospatial data in pediatric asthma in the United States: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to identify and describe the literature on the use of geospatial data in pediatric asthma research. INTRODUCTION: Asthma is one of the most common pediatric chronic diseases in the United States, disproportionately affecting low-income patients. Asthma exacerbations may be triggered by local environmental factors, such as air pollution or exposure to indoor allergens. Geographic information systems are increasingly recognized as tools that use geospatial data to enhance understanding of the link between environmental exposure, social determinants of health, and clinical outcomes. Geospatial data in pediatric asthma may help inform risk factors for asthma severity, and guide targeted clinical and social interventions. INCLUSION CRITERIA: This review will consider studies that utilize geospatial data in the evaluation of pediatric patients with asthma, ages 2 to 18 years, in the United States. Mixed samples of adults and children will also be considered. Geospatial data will include any external non-clinical geographic-based data source that uses a patient's environment or context. METHODS: The following databases will be searched: PubMed, Embase, Cochrane CENTRAL, CINAHL, ERIC, Web of Science, and IEEE. Gray literature will be searched in DBLP, the US Environmental Protection Agency, Google Scholar, Google search, and a hand search of recent abstracts from relevant conferences. Articles published in English, Spanish, and French from 2010 to the present will be included. Study screening and selection will be performed independently by 2 reviewers. Data extraction will be performed by a trained research team member following pilot testing.

Effect of Motor Intervention for Infants and Toddlers With Cerebral Palsy: A Systematic Review and Meta-analysis.

PURPOSE: To conduct a systematic review and meta-analysis on the effect of motor intervention on motor function of infants and toddlers with cerebral palsy (CP). METHODS: Four databases were searched for randomized controlled trials (RCTs) of motor interventions for children with or at high risk of CP younger than 36 months. Studies were excluded if less than 50% of children developed CP. RESULTS: Eleven RCTs included 363 children; 85% diagnosed with CP. Very low-quality evidence supports that: (1) task-specific motor training was more effective than standard care for improving motor function (small effect), (2) constraint-induced movement therapy (CIMT) may be more effective than bimanual play or massage for improving function of the more affected hand (moderate effect), and high-intensity treadmill training is no more effective than low-intensity for improving walking. CONCLUSIONS: Very low-quality evidence supports that task-specific motor training and CIMT may improve motor function of infants and toddlers with CP.The Supplemental Digital Content Video Abstract is available at: http://links.lww.com/PPT/A382 .

Integrating primary care and childhood cancer survivorship care: a scoping review protocol.

INTRODUCTION: Improved treatment regimens have led to increased survival rates among childhood cancer survivors (CCS), and more than 84% of all children diagnosed with cancer will experience long-term survival or cure. Survivors are susceptible to late effects of cancer treatment often requiring lifelong follow-up care, as many of these conditions can be prevented or mitigated with surveillance. Integrating primary care (PC) and childhood cancer survivorship care can improve follow-up for survivors, however, little integrative research exists. This scoping review aims to: identify and describe existing models of care that integrate PC and childhood cancer survivorship care, examine the effectiveness of these models of care, and characterise the barriers and facilitators for the integration of PC for CCS. METHODS AND ANALYSIS: A comprehensive empirical literature search of three electronic databases (PubMed, CINAHL, and Embase) was employed to identify potentially relevant citations on 1 October 2020. The population, independent variables/intervention, comparator, outcomes, timing, setting and study design/other limiters (PICOTSS) framework was used to inform protocol development. The Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist and explanation will be used to report study findings. The search strategy will be completed again prior to publication to ensure recent empirical research is accounted for. ETHICS AND DISSEMINATION: This research is exempt from Institutional Review Board (IRB) review. Approval from a research ethics board for this study was not required as it does not involve human participants or unpublished secondary data. The findings from this scoping review will be disseminated through peer-reviewed scientific manuscripts, clinical conference presentations, professional networks and digital communications using social media platforms such as Twitter. This study has been registered with Open Science Framework: https://osf.io/92xbg.

Diagnosis, management, and outcomes of pediatric tracheostomy-associated infections: A scoping review.

BACKGROUND: Children with tracheostomy are frequently admitted to the hospital for tracheostomy-associated respiratory infections (TRAINs). However, there remains a paucity of evidence to direct the diagnosis, treatment, and prevention of TRAINs. An important first step to addressing this knowledge gap is to synthesize existing data regarding TRAINs to inform current practice and facilitate innovation. DATA SOURCES: We searched PubMed, Embase, Cochrane Library, CINAHL, and Web of Science from inception to October 2020. Original research articles and published abstracts including children and young adults 0-21 years of age with tracheostomy were included. Included studies assessed the clinical definitions of and risk factors for TRAINs, microbiologic epidemiology and colonization of tracheostomies, and treatment and outcomes of TRAINs. DATA SYNTHESIS: Out of 5755 studies identified in the search, 78 full-text studies were included in the final review. A substantial number of studies focused on the detection of specific pathogens in respiratory cultures including Pseudomonas aeruginosa. Several different definitions of TRAIN including clinical, microbiologic, and laboratory testing results were utilized; however, no uniform set of criteria were identified. The few studies focused on treatment and prevention of TRAIN emphasized the role of empiric antimicrobial therapy and the use of inhaled antibiotics. CONCLUSIONS: Despite a growing number of research articles studying TRAINs, there is a paucity of prospective interventional trials to guide the diagnosis, treatment, and prevention of respiratory disease in this vulnerable population. Future research should include studies of interventions designed to improve short- and long-term respiratory-related outcomes of children with tracheostomy.

Self-management for youth and young adults with special health needs: protocol for a scoping review of health care transition planning literature.

OBJECTIVE: The purpose of this scoping review is to explore the extent to which self-management of youth and young adults with special health care needs is reported in the health care transition literature. INTRODUCTION: It is essential for youth and young adults with special health care needs to learn the self-management skills, to the extent possible, that are essential in maintaining the stability of their chronic condition to seamlessly transfer to adult care and live independently. Acquisition of self-management competencies for chronic care management is an essential component of health care transition preparation. INCLUSION CRITERIA: The inclusion criteria will be based upon age and condition designation. The age range of participants will include youth and young adults, aged nine to 35 years, who have special health care needs. Inclusion criteria consists of both non-categorical and diagnostic specific terminology for youth and young adults with a childhood acquired chronic condition. Non-categorical terms used include "long-term chronic condition," "special health care needs," "medical complex condition," "complex care needs," "developmental disability," "intellectual disability," "mental health condition," "emotional disabilities," "physical disabilities," "chronic illness," and "chronic condition." METHODS: The following databases will be accessed for this health care transition scoping review: CINAHL, Cochrane CENTRAL, Embase, Ovid MEDLINE, PsycINFO, and Web of Science. Relevant gray literature will be accessed as well. The Covidence software platform will be used to review citations and full-text articles. Two reviewers will independently review abstracts and full texts of studies, and extract data using the data extraction tool. Any conflicts will be resolved with a third reviewer. Review findings will be presented in tabular format and narrative synthesis based upon the scoping review objective.

The Use of Telemedicine for Home-Based Palliative Care for Children With Serious Illness: A Scoping Review.

CONTEXT: There is potential value to home-based palliative care for children with serious illness delivered via telemedicine (TM HBPC). Evidence to guide optimal design and delivery of TM HBPC is urgently needed. OBJECTIVES: To explore the existing literature to identify research on pediatric TM HBPC. METHODS: Systematic scoping review conducted following preferred reporting items for systematic reviews and meta-analysis for scoping reviews guidelines. PubMed, Embase, Cochrane CENTRAL, CINAHL, Web of Science, PsycINFO, and ERIC were searched (January-April 2020) using keywords and controlled vocabulary. The Reach, Effectiveness, Adoption, Implementation, Maintenance framework was used to identify components in the literature that facilitate or limit dissemination of TM HBPC interventions. RESULTS: Seventeen articles were included. Most of the literature comprised small descriptive studies, such as case reports, and feasibility trials. Many studies focused on acceptability, and the TM HBPC model was generally acceptable to both clinicians and families. Few studies measured patient access to care, patient, and family centered health or quality of life outcomes. While included studies addressed multiple criteria for each of the Reach, Effectiveness, Adoption, Implementation, Maintenance dimensions, much of the information was qualitative and subjective. CONCLUSION: TM HBPC is a promising strategy to increase access to palliative care for children with serious illness. However, the current review found a need for more robust information describing implementation and effectiveness of TM HBPC models, adaptation across care settings, and maintenance over time to guide and facilitate broader dissemination.

The Use of Near-Infrared Spectroscopy (NIRS) to Measure Cerebral Oxygen Saturation During Body Position Changes on Infants Less than One Year Old.

OBJECTIVE: To describe the state of the literature for near-infrared spectroscopy (NIRS) to measure cerebral oxygen saturation during body position changes on infants <1 year old. INTRODUCTION: Although regional cerebral oxygen saturation is commonly used in critically ill populations, it is not usual practice to tailor care based on differences in the cerebral oxygen saturation during measurements in different body positions. We believe that alterations in cerebral oxygen saturation during position changes can also inform clinicians regarding brain health, such as the regulation of brain blood flow. INCLUSION CRITERIA: We included studies in infants <1 year old; who had cerebral oxygen saturation measured in varying positions (e.g. supine versus side-lying). METHODS: On March 30, 2019, we searched Medline, Embase, Cochrane CENTRAL, CINAHL, and Web of Science for studies written in English with no restriction on publication dates. We selected studies that involved infants <1 year old and measured cerebral oxygen saturation during varying body positions. RESULTS: We found 24 primary studies on 694 infants. The authors investigated whether brain oxygen saturation was influenced by body position. A majority of the studies found a statistically significant difference between cerebral oxygen saturation in various body positions. CONCLUSIONS: More research needs to be performed on variations in brain oxygen saturation during body position changes and the correlation with outcomes. Knowledge of brain oxygen saturation can provide clinicians an understanding of the infant's brain health. Healthcare providers may adapt care specifically to improve brain health with NIRS-based brain oxygen saturation monitoring.

Psychosocial outcomes for adults with spina bifida: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to explore the evidence on psychosocial needs and related outcomes for adults with spina bifida. INTRODUCTION: Individuals with spinal bifida have complex service needs that can lead to the emergence of secondary conditions and health complications, which can result in serious, life-threatening illnesses. While much is known about the biological impact of spina bifida, there is a dearth of information regarding its psychological and social impact. INCLUSION CRITERIA: This scoping review will include adults (18 years and over) with the following diagnoses: spina bifida, neural tube defects, tethered cord, myelodysplasia/myelodysplasias, diastematomyelia/diastematomyelias, meningomyelocele, terminal myelocystocele, fatty thickened filum, split cord malformation, or lipomyelomeningocele. The literature reviewed will explore the range and trend of topics reported from the time data on adults with spinal bifida were first published published to the most current time frame. This review will report on the psychosocial needs identified for adults with spinal bifida, such as access to community-based services and support needed to function independently. There will be no limits to the geographical location or setting (e.g. health care or community-based). METHODS: The following databases will be accessed for this review: Ovid MEDLINE, Embase, Cochrane Library, CINAHL, Web of Science, PsycINFO, and ERIC, with no date restrictions. Gray literature searches will be included. Potentially relevant studies will be assessed independently by two reviewers for inclusion and conflicts discussed with a third reviewer. The review narrative will be accompanied by findings presented in tabular format.

Applications of Head-Mounted Displays for Virtual Reality in Adult Physical Rehabilitation: A Scoping Review.

IMPORTANCE: Head-mounted displays for virtual reality (HMD-VR) may be used as a therapeutic medium in physical rehabilitation because of their ability to immerse patients in safe, controlled, and engaging virtual worlds. OBJECTIVE: To explore how HMD-VR has been used in adult physical rehabilitation. DATA SOURCES: A systematic search of MEDLINE, Embase, Cochrane Library, CINAHL, Web of Science, PsycINFO, and ERIC produced 11,453 abstracts, of which 777 underwent full-text review. STUDY SELECTION AND DATA COLLECTION: This scoping review includes 21 experimental studies that reported an assessment or intervention using HMD-VR in a physical rehabilitation context and within the scope of occupational therapy practice. FINDINGS: HMD-VR was used for assessment and intervention for patients with a range of disorders, including stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease. CONCLUSIONS AND RELEVANCE: HMD-VR is an emerging technology with many uses in adult physical rehabilitation. Higher quality clinical implementation studies are needed to examine effects on patient outcomes. WHAT THIS ARTICLE ADDS: We review existing research on how immersive virtual reality (e.g., using head-mounted displays) has been used for different clinical populations in adult physical rehabilitation and highlight emerging opportunities in this field for occupational therapists.