Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.

Interconsultas al Área de Psicopedagogía de un hospital de niños de la CABA antes y durante la pandemia por COVID- 19 / Referrals to the Psychopedagogy Area of a CABA children's hospital before and during the VOCID pandemic 19

Investigación destinada a describir y caracterizar las particularidades de las interconsultas solicitadas al Área de Psicopedagogía de la Unidad de Salud Mental del Hospital de Niños Ricardo Gutiérrez durante el año inmediatamente anterior y en el primer año de la pandemia por Covid 19 en la Argentina a partir de un análisis de los registros del equipo. Otros objetivos son: Describir socioepidemiológicamente a los pacientes por los cuales se interconsultó al Área de Psicopedagogía desde marzo de 2019 a marzo de 2021; caracterizar las particularidades de las interconsultas; y comparar las particularidades de las interconsultas antes y durante el ASPO por la pandemia de COVID 19.

A contemporary snapshot of circumcision in US children's hospitals.

BACKGROUND: In 2012, the American Academy of Pediatrics (AAP) concluded the health benefits of circumcision during the neonatal period outweigh the risks. This study describes recent trends in male circumcision in freestanding children's hospitals in the United States. METHODS: Using the Pediatric Health Information System (PHIS), male patients <18 years of age who were circumcised without any additional procedures between the years 2010 and 2017 were identified. Data included age at procedure (neonate: 0-30 days, infant: 31-365 days, early childhood: ≥1 to <5 years, and older child: ≥5 to<18 years), cost, and specialty performing the circumcision. RESULTS: Of the 171,680 circumcisions performed, 85,270 (50%) were during neonatal period, 29,060 (17%) during infancy, 30,276 (18%) early childhood, and 26,355 (16%) thereafter. Circumcision in neonates increased from 39% to 58% (p < 0.001), and the proportion performed during infancy decreased over time. System level cost for ambulatory circumcision averaged $32 million USD annually, and median cost per ambulatory circumcision was $2892 USD. Obstetricians and Pediatricians are performing proportionally more circumcisions. CONCLUSION: Since 2012, proportionally more neonates are undergoing circumcision in US children's hospitals. Perinatal specialties are performing an increasing proportion of circumcisions. Circumcision during the birth hospitalization in the neonatal period is more resource-effective than postponing until later in infancy. TYPE OF STUDY: Retrospective, cross-sectional analysis. LEVEL OF EVIDENCE: Level IV.

Trends in the delivery of elective general paediatric surgery.

INTRODUCTION: There has been regular dialogue regarding the importance of developing clinical networks to compensate for the steady decline in general paediatric surgery performed by adult surgeons. Despite this dialogue, there are no contemporary published data to quantify the issue. This report documents patterns in delivery of general paediatric surgery in England and shows what is being performed where and by whom. MATERIALS AND METHODS: Using the Surgical Workload Outcome Database, we compared hospital-level data between 2009 and 2017. Inclusion criteria were children under 18 years admitted to NHS hospitals in England for elective general paediatric surgery. Data were analysed with an online statistical package performing paired t-tests. RESULTS: There was no real change in the overall number of elective general paediatric surgical marker cases, but the type mix has changed. The number of marker cases performed by adult surgeons fell by 34% (4699 vs 3090 p < 0.05). The number of marker cases performed by specialist paediatric surgeons increased by 21% (8184 vs 9862 p < 0.05). This increase in workload occurred in both tertiary (21% increase) and peripheral (18% increase) centres. When analysing data by operation type it was apparent that 78% of the increased workload was attributable to an increase in orchidopexy rate. CONCLUSION: Best practice is to treat children close to home by staff with the right skills. This study shows significant shifts in the general paediatric surgical workload. It is important to monitor these trends for successful succession planning as well as configuration of services.

A Survey of Nurses' Need for Care Robots in Children's Hospitals: Combining Robot-Care, Game-Care, and Edu-Care.

The purpose of this study was to investigate nurses' need for care robots in children's hospitals and to help develop care robots that can be used by combining robot-care, game-care, and edu-care. This study employed a mixed-methods design; 198 nurses were recruited for quantitative research and 12 for qualitative research. The findings were as follows. Robot-care: Participants had an overwhelming preference for robots made of plastic or steel that could easily be washed and sterilized. Game-care: Among nursing procedures, vital sign measurements were the most common actions that could be implemented using game elements. Edu-care: The educational content that participants felt should be presented to child patients and caregivers through care robots included information about hospitalization, discharge, infection control, falls, and pressure ulcer prevention. Qualitative data divided the role of care robots into five subcategories associated with children and one subcategory associated with guardians. The findings of this study are meaningful in that it clarified the needs of nurses in the development of care robots for use in children's hospitals.

Pediatric multicenter cohort comparison of percutaneous endoscopic and non-endoscopic gastrostomy technique outcomes.

Enteral access is one of the mainstays of nutritional support. Several different modalities for gastrostomy placement are established. In pediatrics, however, there is a limited evidence base supporting the choice of 1 modality over the others. We retrospectively compared elective percutaneous endoscopically placed gastrostomy (PEG) with surgical and interventional radiology-placed gastrostomy outcomes using the Pediatric Hospital Inpatient Sample multicenter administrative database (Pediatric Health Information System). Pediatric patients (<18 years) undergoing planned elective gastrostomy (2010-2015) were included. Coded gastrostomy procedure subtype, patient demographic characteristics, chronic comorbidities and subsequent related outcomes, mortality, readmission, length of stay and total cost of admission were analyzed. Univariate analysis differentiated among gastrostomy techniques. The effect of gastrostomy on mortality and 30-day readmission were determined using a forward, stepwise, binary logistic regression. Generalized linear models were used to estimate the effect of gastrostomy type on length of stay and total cost. During the study period, 11,712 children underwent gastrostomy, including PEG (27%). Patients with chronic comorbidities were more, or as likely to undergo non-PEG procedures. Postoperatively, PEG patients were less likely to require mechanical ventilation and total parenteral nutrition (TPN). Gastrostomy type was not predictive of mortality; predictors included non-White race and need for mechanically assisted ventilation. Readmission following gastrostomy was common (29.5%), and more likely in PEG patients (OR 1.31). Predictors of readmission included earlier TPN (OR 1.39), cardiovascular (OR 1.17) and oncology (OR 4.17) comorbidities. Our study suggests that PEG placement entails similar length of stay and cost as in non-PEG gastrostomy. Patients undergoing PEG were less likely to require mechanical ventilation and TPN postoperatively. Mortality is similar in both groups although more likely with specific comorbidities. Racial background appeared to be associated with choice of gastrostomy, length of stay and mortality.

Evolving pediatric epidural practice: An institution's clinical experience over 20 years-A retrospective observational cohort study.

BACKGROUND AND OBJECTIVES: Epidural analgesia is an effective, established perioperative intervention in all age-groups. In children, however, epidural-related data are limited compared to the adult population. The aim of this study was to examine the use of pediatric epidural analgesia in our institution and, thereby, add to the existing data pool. METHODOLOGY: Patients who received epidural analgesia as part of their perioperative management between 1996 and 2016 at Great Ormond Street Hospital, London, UK, were studied to determine how epidural practice has changed over time, associated incidence of serious adverse events, complications, and patient/parent satisfaction. Epidural use and monitoring were in accordance with standard hospital protocols. Data were prospectively collected and entered into a secure database by trained personnel. These data were subsequently extracted for retrospective analysis. RESULTS: A total of 3876 patients were included. The median age was 4.4 years (range 1 day to 20 years), and the median weight was 20.3 kg. Across all age-groups, the lumbar region was the most common site of epidural insertion while urology (42.2%) and general surgery (37.3%) were the specialities for which it was most utilized. Over the study period, the number of epidurals performed declined while the number of surgical procedures performed simultaneously increased. The infusate most commonly used was local anesthetic with preservative-free morphine (71.9%). In 923 (23.2%) patients, systemic opioids were additionally used for analgesic management by means of patient-controlled analgesia or nurse-controlled analgesia. There was one serious adverse event in the form of permanent nerve injury, giving an overall incidence of approximately 1:3800. Other complications included postoperative nausea and vomiting (35.9%), urinary retention (4.4%), and pruritus (31%). Overall global satisfaction with the service was generally high, with 95% providing a rating of "very good" or "good." CONCLUSION: This study evaluated two decades of epidural practice in our institution. Epidural analgesia remains a safe, effective option for postoperative analgesia, but its use has declined over time, and this trend is likely to continue. Rates of serious adverse events and complications were low and comparable to those published in other similar studies. Global satisfaction among patients/parents remains high.

Outcomes and complications for individual neurosurgeons for the treatment of Chiari I malformation at a children's hospital.

PURPOSE: The aim of this study was to evaluate the outcomes and complications for individual surgeons at British Columbia Children's Hospital for the treatment of Chiari I Malformation (CMI) in children. METHODS: This was a retrospective review of patients with CMI who had surgery from 1986 to 2015. We assessed the Chicago Chiari Outcome Scores (CCOS) and complication rates by surgeon. RESULTS: Seventy patients, 38 males and 32 females, underwent posterior fossa decompression including 14 extradural and 56 intradural approaches. Syringomyelia was present in 74.3%. Most syringomyelia improved with no difference between intradural and extradural surgeries. After initial surgery, 13 patients (18.6%) had complications including 2/14 (14.3%) of extradural and 11/56 (19.6%) of intradural surgeries. Two patients required surgical intervention for complications whereas 11 had transient complications. The complication rate by surgeon ranged from 11 to 20% for extradural (2 surgeons only) and 10.5 to 40% for intradural surgeries (4 surgeons). The CCOS ranged from 12 to 15 for extradural and 6 to 16 for intradural. The CCOS ranges for surgeons 1 and 2 were 12-15 and 13-15 respectively for extradural. The CCOS ranges for surgeons 1, 2, 3, and 4 were 12-16, 6-15, 12-16, and 12-16 respectively for intradural. Thirteen patients had a second surgery for CMI. The final CCOS was good in 86% and moderate in 14%. CONCLUSION: There was variability in surgeries performed at BCCH by different surgeons, with variations in CCOS and complication rates. This information is important during decision making, consent process, and for quality improvement.

Improve Healthcare Quality Through Mortality Committee: Retrospective Analysis of Bambino Gesù Children Hospital's Ten Years' Experience 2008-2017.

BACKGROUND: Healthcare quality improvements are one of the most important goals to reach a better and safer healthcare system. Reviewing in-hospital mortality data is useful to identify areas for improvement, and to monitor the impact of actions taken to avoid preventable cases, such as those related to healthcare associated infections (HAI). METHODS: In this paper, we present the experience of the Mortality Committee of Bambino Gesù Children Hospital (OPBG). OPBG has instituted a process of systematic revision of all in-hospital deaths conducted by a multidisciplinary team. The goal is to identify system-wide issues that could be improved to reduce in-hospital preventable deaths. In this way, the mortality review goes alongside all the other risk management activities for the continuous quality improvement and patient safety. RESULTS: In years 2008-2017, we performed a systematic analysis of 1148 inpatient deaths. In this time period, the overall mortality rate was 0.4%. Forty-seven deaths were caused due to infections, 10 of which involved patients with HAI transferred to OPBG from other facilities or patients with community- acquired infections. Six deaths related to HAI were followed by claims compensations. All these cases were not followed by compensation because the onset of HAI was considered an inevitable consequence of the underlying disease. CONCLUSION: Introduction of the mortality review committee has proved to be a valid instrument to improve the quality of the care provided in a hospital, allowing early identification of care gaps that could lead to an increase in mortality rates. Article Highlights Box: Reduction of preventable deaths is one of the most important goals to be achieved for any health-care system and to improve the quality of care. • Several studies have shown that analysis of morbidity and mortality rate helps to detect any factors that can lead to an increase in in-hospital mortality rates. • The review of in-hospital deaths allows to learn how to improve the quality and safety of care through identification of critical issues that lead to an increase in mortality ratio. • In some medical areas, such as intensive care units or surgery, the implementation of the conference on mortality and morbidity is more useful for assessing procedures at high risk of errors. • The implementation of existing databases with data deriving from the systematic review of medical records and in-hospital deaths appears to be desirable. • Mortality Review Committees can represent a very useful tool for all the health facilities for the reduction of preventable deaths, such as those related to HAI.

Crohn's & Colitis Australia inflammatory bowel disease audit: measuring the quality of care in Australia.

BACKGROUND: Australia has among the highest prevalence of Crohn disease and ulcerative colitis in the world. Management of the chronic gastrointestinal disorders results in significant societal costs and the standard of care is inconsistent across Australia. AIM: To audit the quality of care received by patients admitted for inflammatory bowel disease (IBD) across Australia against national IBD standards. METHODS: A retrospective cross-sectional survey and clinical audit was undertaken assessing organisational resources, clinical processes and outcome measures. This study was conducted in Australian hospitals that care for inpatients with Crohn disease or ulcerative colitis. The main outcome measures were adherence to national IBD standards and comparison of quality of care between hospitals with and without multidisciplinary IBD services. RESULTS: A total of 71 hospitals completed the organisational survey. Only one hospital had a complete multidisciplinary IBD service and 17 had a partial IBD service (IBD nurse, helpline and clinical lead). A total of 1440 inpatient records was reviewed from 52 hospitals (mean age 37 years; 51% female, 53% Crohn disease), approximately 26% of IBD inpatient episodes over a 12-month period in Australia. These patients were chronically unwell with high rates of anaemia (30%) and frequent readmissions (40% within 2 years). In general, care was inconsistent, and documentation was poor. Hospitals with a partial IBD service performed better in many processes and outcome measures: for example, 22% reduction in admissions through emergency departments and greater adherence to standards for safety monitoring of biological (89% vs 59%) and immunosuppressive drugs (79% vs 55%) in those hospitals than those without. CONCLUSION: Patients admitted to hospital suffering from IBD are young, chronically unwell and are subject to substantial variations in clinical documentation and quality of care. Only one hospital met accepted standards for multidisciplinary care; hospitals with even a minimal IBD service provided improved care.

Pediatric Vascular Surgical Practice Patterns.

BACKGROUND: Vascular surgeons infrequently care for pediatric patients. As such, variability in operative management and available hospital resources at free-standing children's hospitals (CHs) may exist. The study aims were (1) to determine vascular surgeon comfort level with pediatric vascular surgery and (2) to determine variations in pediatric vascular surgery practice patterns. METHODS: A survey composed of clinical vignettes emailed to all members of Vascular and Endovascular Surgery Society was designed to assess operative management of pediatric vascular conditions and hospital resources. Comparisons of surgeon satisfaction between free-standing CHs and a CH within an adult general hospital were made using Wilcoxon rank-sum tests. Comparison of surgeon comfort between hospital types was made using a McNemar's test. P-values less than or equal to 0.05 indicated statistical significance. RESULTS: Response rate was 18% (93/525) with 96% (89/93) indicating completion of a 2 year vascular fellowship. Surgeon satisfaction with operative equipment (P = 0.002), support staff (P < 0.001), and vascular laboratory availability (P = 0.01) was significantly lower at CHs. Eighty-seven percent of surgeons operated on fewer than 2 children over the preceding 3 months. For the different clinical vignettes, there was a wide variation in practice patterns with a range of 50-89% of the surgeons performing fewer than 5 cases over the preceding 10 years. There was a significant decrease in surgeon's comfort level with elective pediatric vascular operations compared to the operative management of pediatric vascular trauma (P = 0.0025). CONCLUSIONS: Most vascular surgeons do not feel comfortable in the operative management of pediatric vascular disease, and optimal resource availability within pediatric CHs may be lacking. Centralized care of this patient population may be warranted.

Red Blood Cell Transfusion in Pediatric Orthotopic Liver Transplantation: What a Difference a Few Decades Make.

BACKGROUND: Liver transplantation in children is often associated with coagulopathy and significant blood loss. Available data are limited. In this observational retrospective study, we assessed transfusion practices in pediatric patients undergoing liver transplantation at a single institution over the course of 9 years. METHODS: Data were retrospectively collected from patient medical records at the Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center. All patients who underwent liver transplantation from January 2008 to June 2017 were included. Primary and secondary outcomes were volume of red blood cells (RBCs) transfused and mortality, respectively. RESULTS: From January 2008 to June 2017, there were 278 liver transplants in 271 patients. The number of primary transplants were 259, second retransplants 15, and third retransplants 4. Average age at transplantation was 6.9 years. Biliary atresia, maple syrup urine disease, urea cycle defect, and liver tumor were the leading indications accounting for 66 (23.7%), 45 (16.2%), 24 (8.6%), and 23 (8.3%) of transplants, respectively. Seventy-six cases (27.3%) did not require RBC transfusions. Among those transfused, 181 (89.6%) of the cases required <1 blood volume (BV). The median BV transfused among all cases was 0.21 (range, 0-9; Q1, 0; Q3, 0.45). There is a trend toward higher volume transfusions among infants (median, 0.46 BV) compared to children >12 months of age (0.12 BV). By diagnosis, the group requiring the highest median volume transfusion was patients with total parenteral nutrition-related liver failure (3.41 BV) followed by patients undergoing repeat transplants (0.6 BV). Comparison of primary versus repeat transplants shows a trend toward higher volume transfusions in third transplants (median, 2.71 BV), compared to second transplants (0.43 BV) and primary transplants (0.18 BV). Four of 271 patients (1.5%) died during admission involving liver transplantation. Nine of 271 patients (3.3%) died subsequently. Total mortality was 4.8%. CONCLUSIONS: In contrast to historically reported trends, evaluation of current transfusion practices reveals that most patients undergoing liver transplantation receive <1 BV of packed RBCs. More than 1 in 4 transplantations require no transfusion at all. Risk factors for greater transfusion need include younger age, total parenteral nutrition-related liver failure, and repeat transplantation.

Preliminary experience of tigecycline treatment for infection in children with hematologic malignancies.

Background Severe infection is life-threatening in children with hematologic malignancies and its treatment is challenging because of an increasing number of multidrug-resistant pathogens. Tigecycline has an expanded antibacterial activity spectrum; some successful cases of tigecycline treatment have been reported in the literature. Objective To examine the efficacy and safety of tigecycline in children. Setting Department of hematologic malignancies in a tertiary hospital. Method A retrospective chart review from May 1, 2012 to May 1, 2017. The patients were identified by the hospital information system and a custom-made Microsoft Excel 2007 database of patients was created to record demographic and medical data. Main outcome measure Efficacy and safety of tigecycline use in severe infection children with hematologic malignancies. Results Thirty-seven patients were enrolled and the predominant diagnosis was acute lymphoblastic leukemia. The median duration of tigecycline therapy was 9 days. Most prescriptions were empirical. Eighteen patients received a maintenance dose of 2 mg/kg q12 h, without a loading dose. Sulperazone was the most frequently prescribed concomitant drug. At the end of tigecycline therapy, improvement was observed in 48.7% of cases. After treatment, interleukin-10 levels notably decreased. The only reported adverse event was a case of tooth discoloration. Conclusion Tigecycline can be used as salvage therapy in children with hematologic malignancy and seems tolerable. Prospective controlled studies are required to definitively evaluate the efficacy and safety of tigecycline in children.

Is unilateral lower leg orthosis with a circular foot unit in the treatment of idiopathic clubfeet a reasonable bracing alternative in the Ponseti method? Five-year results of a supraregional paediatric-orthopaedic centre.

BACKGROUND: In the Ponseti treatment of idiopathic clubfoot, children are generally provided with a standard foot abduction orthosis (FAO). A significant proportion of these patients experience irresolvable problems with the FAO leading to therapeutic non-compliance and eventual relapse. Accordingly, these patients were equipped with a unilateral lower leg orthosis (LLO) developed in our institution. The goal of this retrospective study was to determine compliance with and the efficacy of the LLO as an alternative treatment measure. The minimum follow-up was 5 years. RESULTS: A total of 45 patients (75 ft) were retrospectively registered and included in the study. Compliance with the bracing protocol was 91% with the LLO and 46% with the FAO. The most common problems with the FAO were sleep disturbance (50%) and cutaneous problems (45%). Nine percent of patients experienced sleep disturbance, and no cutaneous problems occurred with the LLO. Thirteen percent of patients being treated with an FAO until the age of four (23 patients; 40 ft) underwent surgery because of relapse, defined by rigid recurrence of any of the components of a clubfoot. Fourteen percent of patients being treated with an LLO (22 patients; 35 ft), mostly following initial treatment with an FAO, experienced recurrence. CONCLUSION: Changing from FAO to LLO at any point during treatment did not result in an increased rate of surgery and caused few problems.

Increasing Incidence and Recurrence Rate of Venous Thromboembolism in Paediatric Oncology Patients in One Single Centre Over 25 Years.

Venous thromboembolism (VTE) is a serious complication in paediatric oncology patients. To identify the incidence, risk factors and recurrence rate of VTE in paediatric oncology patients, an observational, retrospective cohort study of all consecutive children (≤18 years) with malignancies, treated at the Emma Children's Hospital Academic Medical Centre between January 1989 and December 2013, was done. A matched case-control study in children with lymphomas was performed, to identify thrombotic risk factors. Cumulative recurrence-free survival after first VTE was estimated by the Kaplan-Meier method. Of the 2,183 children included (male: female = 1.4:1.0; median age, 6.6 years) with cancer, 78 patients developed VTE (3.6%; 95% confidence interval [CI], 2.8-4.4). The incidence increased from 0.8% (4/478, 95% CI, 0.0-1.6) between 1989 and 1993 to 10.4% (44/423, 95% CI, 7.6-13.4) between 2009 and 2013. Independent risk factors for VTE were age ≥ 12 years, acute lymphoblastic leukaemia (ALL) and lymphoma. The case-control study in lymphoma patients showed a trend for increased VTE incidence in stage IV lymphoma. Twelve (15.4%) patients developed recurrent thrombosis, 7 patients while on therapeutic or prophylactic anticoagulation. The cumulative recurrence-free survival after first VTE was 88.5, 87.1 and 80.6% after 1, 5 and 10 years, respectively. In conclusion, we demonstrated an increasing incidence of VTE in children with malignancies, with age ≥ 12 years, ALL and lymphoma as independent risk factors. The elevated recurrence rate underlines the importance of full anticoagulant therapy and might warrant prophylactic anticoagulation after first VTE during cancer treatment.