Incidence, severity, and preventability of adverse events during the induction of patients with acute lymphoblastic leukemia in a tertiary care pediatric hospital in Mexico.

Healthcare-associated adverse events represent a heavy burden of symptoms for pediatric oncology patients. Their description allows knowing the safety and quality of the care processes in countries with limited resources. This study aimed to describe the incidence, types, severity, and preventability of adverse events occurring in pediatric patients with acute lymphoblastic leukemia during the induction phase in a tertiary care pediatric hospital in Mexico. This study analyzed a cohort based on medical records of between 2015 and 2017. Initially, information on patients and adverse events was collected; subsequently, two pediatric oncologist reviewers independently classified adverse events, severity and preventability. Agreement between reviewers was evaluated. Adverse events incidence rates were estimated by type, severity, and preventability. One-hundred and eighty-one pediatric patients pediatric patients with acute lymphoblastic leukemia were studied. An overall adverse events rate of 51.8 per 1000 patient-days was estimated, involving 81.2% of patients during induction. Most adverse events were severe or higher (52.6%). Infectious processes were the most common severe or higher adverse event (30.5%). The presence of adverse events caused 80.2% of hospital readmissions. Of the adverse events, 10.5% were considered preventable and 53.6% could be ameliorable in severity. Improving the safety and quality of the care processes of children with acute lymphoblastic leukemia is possible, and this should contribute to the mitigation and prevention of adverse events associated morbidity and mortality during the remission induction phase.

Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017.

INTRODUCTION: In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children. OBJECTIVE: To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico. METHODS: A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package. RESULTS: Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs. CONCLUSION: ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary.

Delivery of Pediatric Cancer Care in Mexico: A National Survey.

Purpose Limited data describe the delivery of pediatric cancer care in Mexico. We report a nationwide survey of pediatric cancer units. Methods An electronic survey was distributed to 74 pediatric cancer units in Mexico to describe case volumes; organization of care; and availability of medical/surgical specialists, supportive care, complex therapies, and diagnostic services. Centers were classified as low (< 30 new patients/year), medium (30 to 59/year) and high (≥ 60/year). Results Sixty-two centers completed the survey (response rate, 84%). The median annual new case volume per center was 50 (interquartile range [IQR], 23 to 81). Thirty-four percent (n = 21), 26% (n = 16), and 40% (n = 25) of units were low-, medium-, and high-volume centers, respectively. Treatment units reported a median of two pediatric oncologists (IQR, 2) and one pediatric hematologist (IQR, 1 to 2). Availability of medical and surgical subspecialists varied by center size, with substantially more specialist support at higher-volume centers ( P < .01). Multidisciplinary tumor boards are available at 29% (six of 21), 56% (nine of 16), and 76% (19 of 25) of low- to high-volume centers, respectively ( P = .005). Radiation and palliative care services are available at 42% (n = 26) and 63% (n = 36) of all centers, which did not vary by center volume. Educational support for hospitalized children and school reintegration programs are available at 56% (n = 36) and 58% (n = 36) of centers, respectively. One third (38% [n = 23]) of centers reported that at least one half of patients were lost to follow-up during the transition from pediatric to adult programs. Conclusion A large variation exists in annual case volumes across Mexican pediatric cancer centers. Additional efforts to increase access to multidisciplinary, supportive, and palliative care across all pediatric cancer units in Mexico are required.

Mortality of young people with cancer: clinical-epidemiological characteristics of death and emerging ethical aspects / La mortalidad en adolescentes con cáncer: características clinicoepidemiológicas de muerte y aspectos éticos emergentes.

Objective: To describe the epidemiological, clinical, and ethical aspects of the mortality of young people with cancer in Mexico. Methods: 63 medical records from 14 to 18-year-old patients, with cancer, who died between 2011 and 2014, were reviewed to obtain epidemiological and clinical characteristics of their death. The study sites were three tertiary referral hospitals in Mexico City. Results: Of 40 young people in terminal phase, 16 (40%) continued to receive curative treatment; of the 51 whose place of death was known, 45 (88%) died in hospital. Of the 41 who died within 30 days of their last hospitalization, deaths were due to complications (51%), progression of the disease (41%), and deaths of those in palliative care (7%). Conclusions: Oncological practice rests on what is known as a biomedical model. The results of this study suggest the urgent need for, and support the implementation of, true palliative-care services. More importantly, these findings underscore the necessity of putting the ethics of clinical practice into action, such that best practice in medicine is reinforced.

Objetivo: Describir los aspectos epidemiológicos, clínicos y éticos de la mortalidad de los adolescentes con cáncer en México. Métodos: Se revisaron 63 expedientes clínicos de adolescentes (de 14 a 18 años de edad) con cáncer, fallecidos entre 2011 y 2014, para obtener información clínica y epidemiológica de su muerte. Los sitios de estudio fueron tres hospitales de concentración en la Ciudad de México. Resultados: De los 40 adolescentes con criterios de fase terminal, 16 (40%) continuaron recibiendo tratamiento con fines curativos. De los 51 cuyo lugar de muerte era conocido, 45 (88%) murieron en hospital. De los 41 que murieron dentro de los 30 días de su última hospitalización, las muertes fueron principalmente debidas a complicaciones (51%), a progresión de la enfermedad (41%) o bien fueron muertes en tratamiento paliativo (7%, 3/41). Conclusiones: La práctica oncológica descansa en lo que es conocido como modelo biomédico. Los resultados del estudio sugieren y apoyan la urgente necesidad de implementar verdaderos servicios de cuidados paliativos, pero más importante que eso, está el ímpetu de poner la ética de la práctica clínica en acción, y de ese modo reforzar la buena práctica de la medicina.

Decision-making on therapeutic futility in Mexican adolescents with cancer: a qualitative study.

BACKGROUND: The world literature shows that empirical research regarding the process of decision-making when cancer in adolescents is no longer curable has been conducted in High-income, English speaking countries. The objective of the current study was to explore in-depth and to explain the decision-making process from the perspective of Mexican oncologists, parents, and affected adolescents and to identify the ethical principles that guide such decision-making. METHODS: Purposive, qualitative design based on individual, fact-to-face, semi-structured, in-depth interviews. The participants were thirteen paediatric oncologists, 13 parents or primary carers, and six adolescents with incurable cancer. The participants were recruited from the paediatric oncology services of three national tertiary-care medical centres in Mexico City. RESULTS: The oncologists stated that they broach the subject of palliative management when they have determined that curative treatment has failed. Respect for autonomy was understood as the assent of the parent/adolescent to what the oncologist determined to be in the best interest of the adolescent. The oncologists thought that the adolescent should be involved in the decision-making. They also identified the ability to count on a palliative care clinic or service as an urgent need. For the parents, it was essential that the oncologist be truly interested in their adolescent child. The parents did not consider it necessary to inform the child about impending death. The adolescents stated that the honesty of their oncologists was important; however, several of them opted for a passive role in the decision-making process. CONCLUSION: The findings of this study evidence that to achieve good medical practice in low-middle income countries, like Mexico, it is urgent to begin effective implementation of palliative care, together with appropriate training and continuing education in the ethics of clinical practice.

Análisis de causa-raíz como herramienta para identificar problemas en la atención de pacientes pediátricos con leucemia linfoblástica aguda / Root cause analysis as a tool to identify problems in the medical care of pediatric patients with acute lymphoblastic leukemia

Introducción. El análisis causa-raíz es una técnica cualitativa caracterizada por un proceso secuencial de preguntas orientadas a la prevención de un evento centinela, al buscar conocer e incidir en los diversos componentes que rodean al acto mismo. La leucemia linfoblástica aguda es el cáncer más común en los niños. Debido a su manejo multidisciplinario, es susceptible de generar diversos errores latentes que ponen en riesgo la vida de los pacientes. Métodos. Se realizó un estudio de análisis causa-raíz a nivel nacional, con la participación de siete hospitales afiliados al Seguro Popular. Un panel de expertos analizó el expediente de un paciente pediátrico con leucemia linfoblástica aguda que hubiera fallecido recientemente en cada uno de los centros participantes. Los resultados se describieron y jerarquizaron para, finalmente, identificar las posibles recomendaciones para mejorar la atención al paciente. Resultados. Se consideró que en cuatro de los siete casos las causas de muerte eran prevenibles. Los problemas en la atención fueron relacionados con el manejo heterogéneo de complicaciones infecciosas y hematológicas. Los distintos centros hospitalarios compartieron la mayor parte de los problemas identificados, especialmente los referentes a la falta de personal capacitado y a la insuficiencia de productos hemáticos. Conclusiones. El estudio sienta la base para conocer las deficiencias en los distintos hospitales y propone el análisis de la información para la creación de comités de mejora. El análisis causa-raíz es una herramienta útil dentro de las unidades médicas, para identificar potenciales deficiencias en los procesos de atención.

Background: Root cause analysis is a qualitative technique characterized by a sequential order of questions to prevent errors by the acknowledgment and management of its diverse components. Acute lymphoblastic leukemia is the most common cancer in children. Due to the necessity of a multidisciplinary approach, it can be the target of diverse latent errors, which jeopardize the life of the patient. Methods: We developed a study including seven national institutions affiliated with the Seguro Popular insurance program. We conducted a summary of the clinical records of the most recent death of a pediatric patient with ALL at each institution. Clinical files were analyzed by an expert panel. Results were described and prioritized in order to recommend improvements for care. Results: We considered that 4/7 deaths were preventable. Problems in patient care are related to mismanagement of infectious and hematological complications. Many of the results obtained in the analysis are shared by the institutions with particular emphasis on lack of personnel and insufficient training as well as deficiency of blood products. Conclusions: This study will become the starting point to acknowledge the deficiencies among the different institutions and invites an analysis of the information to create committees for better care practices and to consider RCA as a useful tool within each medical institution to identify deficiencies in the care process.

Análisis de la atención de las complicaciones durante el tratamiento de niños con leucemia linfoblástica aguda / Analysis of complications during treatment of children with acute lymphoblastic leukemia

Introducción. Las complicaciones infecciosas, hematológicas y metabólicas en los niños con leucemia linfoblástica aguda pueden tratarse de forma exitosa. Nuestro objetivo fue conocer cuáles son las características clínicas de los pacientes con complicaciones que contribuyen a la mortalidad de los niños con leucemia linfoblástica aguda, y los procesos de atención con apego a la Guías Clínicas del Children's Oncology Group. Métodos. Se realizó un estudio de casos y controles en nueve hospitales con diferentes tasas de sobrevida afiliados al Seguro Popular. Se analizaron las características clínicas y el proceso de atención en complicaciones como choque séptico, neutropenia y fiebre, anemia grave, hemorragias, síndrome de lisis tumoral e hiperleucocitosis. Resultados. En los pacientes con choque séptico, la neutropenia profunda y la confirmación de la fiebre influyeron en la mortalidad. También el retraso en la administración de la primera dosis de antibióticos, así como la falta de adherencia a las Guías Clínicas del Children's Oncology Group. No hubo diferencias clínicas ni de los procesos de atención que afecten significativamente en la anemia grave y hemorragias. Conclusiones. La falta de apego a las Guía Clínicas del Children's Oncology Group influye significativamente en la mortalidad por complicaciones infecciosas. Deben sistematizarse las acciones a realizar en algunos procesos de atención. En hospitales equipados, es evitable la muerte de pacientes con ciertas complicaciones.

Background. Infectious, hematologic and metabolic complications in children with acute lymphoblastic leukemia (ALL) can be successfully treated. The objective of this study was to determine the clinical characteristics of patients with complications that contribute to mortality in children with ALL and healthcare processes through adherence to the Children's Oncology Group Clinical Guidelines (GCCOG). Methods. We performed a case-control study in nine hospitals affiliated with the Seguro Popular insurance program, analyzing clinical characteristics and treatment of febrile neutropenia, septic shock, severe anemia, hemorrhage, lysis tumoral syndrome and hyperleucocytosis. Results. In patients with septic shock, profound neutropenia and confirmation of fever influences mortality. Antibiotic administration delays treatment and lack of adherence to the clinical guidelines of COG. There were no clinical differences in severe anemia and hemorrhage or in the health care processes. Conclusions. Lack of adherence to clinical guidelines has had an impact on mortality in infectious complications. There is a lack of sys-tematization in some care processes. In certified hospitals, there are reports that patients died from avoidable complications.