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Journal of Medical Engineering &... Nov 2023Access to medical technologies is a critical component of universal access to care; however, the advancement of technologies for children has historically lagged behind... (Review)
Review
Access to medical technologies is a critical component of universal access to care; however, the advancement of technologies for children has historically lagged behind those for adults. The small market size, anatomic and physiologic variability, and legal and ethical implications pose unique barriers to developing and commercialising paediatric biomedical innovations. These challenges are magnified in low-resource settings (LRS), which often lack appropriate regulatory oversight, support for service contracts, and supply chain capacity. The COVID-19 pandemic exposed shortcomings in the traditional industry model for medical technologies, while also catalysing open-source approaches to technology development and dissemination. Open-source pathways - where products are freely licenced to be distributed and modified - addressed key shortages in critical equipment. Relatedly, we argue that open-source approaches can accelerate paediatric global health technology development. Open-source approaches can be tailored to clinical challenges independent of economic factors, embrace low-cost manufacturing techniques, and can be highly customisable. Furthermore, diverse stakeholders, including families and patients, are empowered to participate in collaborative communities of practice. How to regulate the development, manufacture, and distribution of open-source technologies remains an ongoing area of exploration. The need for democratised innovation must be carefully balanced against the imperatives of safety and quality for paediatric-specific solutions. This can be achieved, in part, through close coordination between national regulatory agencies and decentralised networks where products can be peer-reviewed and tested. Altogether, there is significant potential for open source to advance more equitable and sustainable medical innovations for all children.
Topics: Humans; Global Health; COVID-19; Biomedical Technology; Child; Pediatrics; SARS-CoV-2; Pandemics
PubMed: 38717814
DOI: 10.1080/03091902.2024.2343682 -
Anesthesiology Clinics Sep 2020Trends in pediatric pain management are moving toward thinking beyond opioids. Regional anesthetic techniques, such as quadratus lumborum and erector spinae plane... (Review)
Review
Trends in pediatric pain management are moving toward thinking beyond opioids. Regional anesthetic techniques, such as quadratus lumborum and erector spinae plane blocks, demonstrate efficacy and safety in pediatric populations. Extremity blocks with motor-sparing characteristics also are used. Adjuvants may be added to pediatric peripheral nerve blocks to increase duration of action and improve block efficacy. For medical management, pediatric pain management frequently uses nonopioid medications. These opioid-sparing medications and regional techniques are used to facilitate enhanced recovery after surgery in pediatric surgical patients. Virtual reality is a field where technology can aid in managing acute pain in pediatric patients.
Topics: Analgesics, Opioid; Anesthesia, Conduction; Child; Enhanced Recovery After Surgery; Humans; Pain Management; Pediatrics; Virtual Reality
PubMed: 32792190
DOI: 10.1016/j.anclin.2020.04.002 -
Clinical Pediatrics Dec 2020The aim of this integrative review is to investigate current literature regarding family health history (FHH) taking practices, attitudes, and challenges in the... (Review)
Review
The aim of this integrative review is to investigate current literature regarding family health history (FHH) taking practices, attitudes, and challenges in the pediatric outpatient setting. FHH is a known clinical tool for providers; however, there are no explicit standards for pediatric FHH collection. The integrative review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. PubMed, Embase, CINAHL, PsycINFO, and Cochrane databases were searched for publications between January 2010 and December 2019, and 8 articles were selected for evaluation. Three themes are explored in this review: FHH collection practices, challenges, and tools. FHH collection practices were found to be inconsistent and the most commonly cited challenge was time. No validated FHH collection tools have been identified for the pediatric population. These findings suggest the need for standardization in FHH collection and further development of tools to improve FHH collection.
Topics: Child; Family Health; Humans; Medical History Taking; Pediatrics
PubMed: 32703020
DOI: 10.1177/0009922820943474 -
The AAPS Journal Jun 2022New drugs may in some cases need to be tested in paediatric and pregnant patients. However, it is difficult to recruit such patients and there are many ethical issues... (Review)
Review
New drugs may in some cases need to be tested in paediatric and pregnant patients. However, it is difficult to recruit such patients and there are many ethical issues around their inclusion in clinical trials. Modelling and simulation can help to plan well-designed clinical trials with a reduced number of participants and to bridge gaps where recruitment is difficult. Physiologically based pharmacokinetic (PBPK) models for small molecule drugs have been used to aid study design and dose adjustments in paediatrics and pregnancy, with several publications in the literature. However, published PBPK models for monoclonal antibodies (mAb) in these populations are scarce. Here, the current status of mAb PBPK models in paediatrics and pregnancy is discussed. Seven mAb PBPK models published for paediatrics were found, which report good prediction accuracy across a wide age range. No mAb PBPK models for pregnant women have been published to date. Current challenges to the development of such PBPK models are discussed, including gaps in our knowledge of relevant physiological processes and availability of clinical data to verify models. As the availability of such data increases, it will help to improve our confidence in the PBPK model predictive ability. Advantages for using PBPK models to predict mAb PK in paediatrics and pregnancy are discussed. For example, the ability to incorporate ontogeny and gestational changes in physiology, prediction of maternal, placental and foetal exposure and the ability to make predictions from in vitro and preclinical data prior to clinical data being available.
Topics: Antibodies, Monoclonal; Child; Computer Simulation; Female; Humans; Models, Biological; Pediatrics; Placenta; Pregnancy
PubMed: 35650328
DOI: 10.1208/s12248-022-00722-0 -
Pediatrics Feb 2021A common reproach precluding the use of osteopathic manipulative medicine (OMM) in pediatrics is a lack of evidence regarding its safety, feasibility, and effectiveness. (Meta-Analysis)
Meta-Analysis
CONTEXT
A common reproach precluding the use of osteopathic manipulative medicine (OMM) in pediatrics is a lack of evidence regarding its safety, feasibility, and effectiveness.
OBJECTIVE
We conducted a systematic, scoping review of pediatric osteopathic medicine to identify gaps in the literature and make recommendations for future research.
DATA SOURCES
We searched 10 databases using 6 key words and medical subject heading terms for any primary articles reporting OMM use in children published from database inception until initiation of the study.
STUDY SELECTION
Articles were selected if they reported primary data on OMM conducted in the United States on patient(s) 0 to 18 years old.
DATA EXTRACTION
Baseline study characteristics were collected from each article and the Grading of Recommendations, Assessment, Development, and Evaluations system was used to critically appraise each study.
RESULTS
Database search yielded 315 unique articles with 30 studies fulfilling inclusion and exclusion criteria. Of these, 13 reported the data required to demonstrate statistically significant results, and no significant adverse events were reported. The majority of studies were graded as providing weak clinical evidence because of significant methodologic flaws and biases.
LIMITATIONS
The review was limited to US-based studies and reports. Minimal discrepancies between reviewers were resolved via an objective third reviewer.
CONCLUSIONS
There is little strong, scientific, evidence-based literature demonstrating the therapeutic benefit of OMM for pediatric care. No strong clinical recommendations can be made, but it can be medically tolerated given its low risk profile. High-quality, scientifically rigorous OMM research is required to evaluate safety, feasibility, and efficacy in pediatrics.
Topics: Adolescent; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Male; Osteopathic Medicine; Pediatrics; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Treatment Outcome
PubMed: 33500321
DOI: 10.1542/peds.2020-016162 -
Archives of Disease in Childhood.... Feb 2022In the UK, the number of junior doctors completing foundation programme, and the number of trainees applying to paediatrics has been in decline in recent years. The NHS... (Review)
Review
BACKGROUND
In the UK, the number of junior doctors completing foundation programme, and the number of trainees applying to paediatrics has been in decline in recent years. The NHS is at 'breaking point', exacerbated by workforce shortages, chronic underfunding, increasing service demand and poor job satisfaction within healthcare workers. Issues in recruitment and retention of paediatricians 'threaten the safety of our children's health', according to the Royal College of Paediatrics and Child Health.
AIM
To explore what strategies have been described in the literature to enhance recruitment and retention in paediatrics.
METHODS
A scoping review methodology was conducted, employing a qualitative approach to review the literature. The studies included were English-language studies. 16 full-text articles were reviewed and analysed.
STUDY FINDINGS
There is a paucity of data in the literature that describes evidence-based approaches to enhancing retention and recruitment in paediatrics. The most important strategies employed to help are identified and grouped into six main themes. These include professional advocacy, workforce diversity, mentorship, improving working conditions, career flexibility and enhancing educational opportunities. The authors have created a 'paediatric pipeline' paradigm of 'identify, engage, recruit, retain and champion', which allow us to present these themes in a pragmatic way for paediatricians and policymakers.
CONCLUSIONS
While some issues share similarities with other specialties in difficulty, much of the context and potential remedies within paediatrics are distinct. A strategic, multi-agency collaborative approach is required urgently to address the significant issues that face both paediatrics and the healthcare system.
Topics: Child; Humans; Pediatricians; Pediatrics; Workforce
PubMed: 33658289
DOI: 10.1136/archdischild-2020-319696 -
Seminars in Pediatric Surgery Oct 2021
Topics: Child; Humans; Pediatrics; Specialties, Surgical
PubMed: 34635276
DOI: 10.1016/j.sempedsurg.2021.151106 -
European Journal of Pharmaceutical... Dec 2020A BCS-based biowaiver allows extrapolation of drug product bioequivalence (when applicable) based on the BCS class of the drug and in vitro dissolution testing. Drug...
A BCS-based biowaiver allows extrapolation of drug product bioequivalence (when applicable) based on the BCS class of the drug and in vitro dissolution testing. Drug permeability and solubility considerations for adult BCS might not apply directly to paediatric subpopulations and bridging of adult and paediatric formulations should be undertaken with caution. The aims of this study were to: (i.) identify compounds which would change drug solubility classification in the paediatric population, and (ii.) to assess the risk of extending BCS-based biowaiver criteria into paediatric products of these compounds. Amoxicillin, prednisolone, and amlodipine were selected as the model compounds. Dissolution studies of IR formulations of these compounds were conducted with USP II (paddle) and mini-paddle apparatus, in media of three pHs (pH 1.2, 4.5 and 6.8). Three dissolution setups were tested: (1) 'typical' BCS-based biowaiver conditions, (2) "BE" setup derived from BE study protocols (volume: 250 mL), and (3) "paediatric" setup based on representative volume for the paediatric population (50 mL). Results revealed that extension of regulated BCS-based biowaiver criteria for paediatric application is not as simple as scaling down volumes. It was further shown that BCS-based biowaiver criteria should not be applied when there is the risk of change of the drug solubility class, from the adult to paediatric populations. A deeper knowledge of the paediatric gastrointestinal environment is still lacking and would assist in refining the biopharmaceutical tools needed to appropriately evaluate formulation performance across age groups. This would potentially reduce the number of clinical studies required and speed up formulation development.
Topics: Adult; Biopharmaceutics; Child; Humans; Pediatrics; Permeability; Solubility; Therapeutic Equivalency
PubMed: 32941998
DOI: 10.1016/j.ejps.2020.105549 -
Anales de Pediatria Mar 2022
Topics: Child; Humans; Pediatrics
PubMed: 35241405
DOI: 10.1016/j.anpede.2021.11.004 -
Current Opinion in Obstetrics &... Oct 2019The current review highlights the complexity of the pediatric and adolescent gynecology subspecialty as well as the recent and exciting opportunities for innovation... (Review)
Review
PURPOSE OF REVIEW
The current review highlights the complexity of the pediatric and adolescent gynecology subspecialty as well as the recent and exciting opportunities for innovation within the field.
RECENT FINDINGS
The opportunities for concept, treatment, instrument, and knowledge-transfer innovation to better serve the specific needs of pediatric gynecology patients include novel approaches to neovagina creation using magnets, improving postoperative vaginal wound healing through newly designed and degradable vaginal stents, and complex Mullerian reconstructive surgical planning using virtual reality immersive experiential training.
SUMMARY
There is a significant window of opportunity to address the needs of pediatric, adolescent and adult gynecological patients with new innovative concepts and tools.
Topics: Adolescent; Child; Female; Gynecology; Humans; Pediatrics; Vagina
PubMed: 31369479
DOI: 10.1097/GCO.0000000000000563