Improving quality and patient safety in surgical care through standardisation and harmonisation of perioperative care (SAFEST project): A research protocol for a mixed methods study.

INTRODUCTION: Adverse events in health care affect 8% to 12% of patients admitted to hospitals in the European Union (EU), with surgical adverse events being the most common types reported. AIM: SAFEST project aims to enhance perioperative care quality and patient safety by establishing and implementing widely supported evidence-based perioperative patient safety practices to reduce surgical adverse events. METHODS: We will conduct a mixed-methods hybrid type III implementation study supporting the development and adoption of evidence-based practices through a Quality Improvement Learning Collaborative (QILC) in co-creation with stakeholders. The project will be conducted in 10 hospitals and related healthcare facilities of 5 European countries. We will assess the level of adherence to the standardised practices, as well as surgical complications incidence, patient-reported outcomes, contextual factors influencing the implementation of the patient safety practices, and sustainability. The project will consist of six components: 1) Development of patient safety standardised practices in perioperative care; 2) Guided self-evaluation of the standardised practices; 3) Identification of priorities and actions plans; 4) Implementation of a QILC strategy; 5) Evaluation of the strategy effectiveness; 6) Patient empowerment for patient safety. Sustainability of the project will be ensured by systematic assessment of sustainability factors and business plans. Towards the end of the project, a call for participation will be launched to allow other hospitals to conduct the self-evaluation of the standardized practices. DISCUSSION: The SAFEST project will promote patient safety standardized practices in the continuum of care for adult patients undergoing surgery. This project will result in a broad implementation of evidence-based practices for perioperative care, spanning from the care provided before hospital admission to post-operative recovery at home or outpatient facilities. Different implementation challenges will be faced in the application of the evidence-based practices, which will be mitigated by developing context-specific implementation strategies. Results will be disseminated in peer-reviewed publications and will be available in an online platform.

Transitional Care Navigation.

OBJECTIVES: This manuscript aims to provide an extensive review of the literature, synthesize findings, and present substantial insights on the current state of transitional care navigation. Additionally, the existing models of care, pertaining to the concept and approach to transitional care navigation, will be highlighted. METHODS: An extensive search was conducted though using multiple search engines, topic-specific key terminology, eligibility of studies, as well as a limitation to only literature of existing relevance. Integrity of the evidence was established through a literature review matrix source document. A synthesis of nursing literature from organizations and professional publications was used to generate a comparison among various sources of evidence for this manuscript. Primary evidence sources consisted of peer-reviewed journals and publications from professional organizations such as the AHRQ, Academic Search Premier, CINAHL Plus with Full Text, and the Talbot research library. RESULTS: A total of five systematic reviews (four with meta-analysis) published between 2016 and 2022 and conducted in several countries (Brazil, Korea, Singapore, and the US) were included in this review. A combined total of 105 studies were included in the systematic reviews with 53 studies included in meta-analyses. The review of the systematic reviews identified three overarching themes: care coordination, care transition, and patient navigation. Care coordination was associated with an increase in care quality rating, increased the health-related quality of life in newly diagnosed patients, reduced hospitalization rates, reduced emergency department visits, timeliness in care, and increased appropriateness of healthcare utilization. Transitional care interventions resulted to reduced average number of admissions in the intervention (I) group vs control (C) (I = 0.75, C = 1.02) 180 days after a 60-day intervention, reduced readmissions at 6 months, and reduced average number of visits 180 days after 60-day intervention (I = 2.79, C = 3.60). Nurse navigators significantly improved the timeliness of care from cancer screening to first-course treatment visit (MD = 20.42, CI = 8.74 to 32.10, P = .001). CONCLUSION: The care of the cancer patient entails treatments, therapies, and follow-up care outside of the hospital setting. These transitions can be challenging as they require coordination and collaboration among various health care sites. The attributes of transitional care navigation overlap with care coordination, care transition, and patient navigation. There is an opportunity to formally develop a transitional care navigation model to effectively addresses the challenges in care transitions for patient including barriers to health professional exchange of information or communication across care settings and the complexity of coordination between care settings. The transitional care navigation and clinic model developed at a free-standing NCI-designated comprehensive cancer center is a multidisciplinary approach created to close the gaps in care from hospital to home. IMPLICATIONS FOR NURSING PRACTICE: A transitional care navigation model aims to transform the existing perspectives and viewpoints of hospital discharge and transition of care to home or post-acute care settings as two solitary processes to that of a collective approach to care. The model supports provides an integrated continuum of quality, comprehensive care that supports patient compliance with treatment regimens, reinforces patient and caregiver education, and improves health outcomes.

Circulating tumor DNA reveals complex biological features with clinical relevance in metastatic breast cancer.

Liquid biopsy has proven valuable in identifying individual genetic alterations; however, the ability of plasma ctDNA to capture complex tumor phenotypes with clinical value is unknown. To address this question, we have performed 0.5X shallow whole-genome sequencing in plasma from 459 patients with metastatic breast cancer, including 245 patients treated with endocrine therapy and a CDK4/6 inhibitor (ET + CDK4/6i) from 2 independent cohorts. We demonstrate that machine learning multi-gene signatures, obtained from ctDNA, identify complex biological features, including measures of tumor proliferation and estrogen receptor signaling, similar to what is accomplished using direct tumor tissue DNA or RNA profiling. More importantly, 4 DNA-based subtypes, and a ctDNA-based genomic signature tracking retinoblastoma loss-of-heterozygosity, are significantly associated with poor response and survival outcome following ET + CDK4/6i, independently of plasma tumor fraction. Our approach opens opportunities for the discovery of additional multi-feature genomic predictors coming from ctDNA in breast cancer and other cancer-types.

Clinical and Sonographic Classification of Neurofibromas in Children with Neurofibromatosis Type 1 - A Cluster Analysis.

PURPOSE: High-frequency ultrasound allows the accurate identification of neurofibromas in neurofibromatosis type 1 (NF1). This study aimed to analyze the ultrasound features of neurofibromas in children with NF1, to establish a classification based on the clinical and sonographic patterns of the different types of neurofibromas, and to evaluate the interobserver correlation coefficient (κ) of this classification. MATERIALS AND METHODS: In this prospective, single referral center observational study, clinical and ultrasound findings of neurofibromas in children diagnosed with NF 1 were analyzed. To identify the ultrasound patterns, a cluster analysis allowing the inclusion of both clinical and ultrasound data was designed. The κ coefficient was calculated using 9 external evaluators. RESULTS: 265 ultrasound scans were performed on a total of 242 neurofibromas from 108 children diagnosed with NF1. Cluster analysis allowed the identification of 9 patterns (Snedecor's F, P < 0.001) classified as "classic" cutaneous neurofibroma, blue-red neurofibroma, pseudoatrophic neurofibroma, nodular subcutaneous neurofibroma, diffuse subcutaneous neurofibroma, congenital cutaneous neurofibroma, congenital plexiform neurofibroma, congenital diffuse and plexiform neurofibroma, and subfascial neurofibroma. The κ coefficient of the interobserver ratings was 0.82. CONCLUSION: Patterns identified in the cluster analysis allow neurofibromas to be classified with a very high interobserver correlation.

Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial.

The aim of this study was to assess the acceptability and feasibility of offering risk-based breast cancer screening and its integration into regular clinical practice. A single-arm proof-of-concept trial was conducted with a sample of 387 women aged 40-50 years residing in the city of Lleida (Spain). The study intervention consisted of breast cancer risk estimation, risk communication and screening recommendations, and a follow-up. A polygenic risk score with 83 single nucleotide polymorphisms was used to update the Breast Cancer Surveillance Consortium risk model and estimate the 5-year absolute risk of breast cancer. The women expressed a positive attitude towards varying the frequency of breast screening according to individual risk and, especially, more frequently inviting women at higher-than-average risk. A lower intensity screening for women at lower risk was not as welcome, although half of the participants would accept it. Knowledge of the benefits and harms of breast screening was low, especially with regard to false positives and overdiagnosis. The women expressed a high understanding of individual risk and screening recommendations. The participants' intention to participate in risk-based screening and satisfaction at 1-year were very high.

Guillain-Barré Syndrome in Mexico: An Updated Review Amid the Coronavirus Disease 2019 Era

ABSTRACT Guillain-Barré syndrome (GBS) is the most frequent cause of acute flaccid paralysis and if not diagnosed and treated timely, a significant cause of long-term disability. Incidence in Latin America ranges from 0.71 to 7.63 cases/100,000 person-years. Historically, GBS has been linked to infections (mainly gastrointestinal by Campylobacter jejuni) and vaccines (including those against severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]); however, a trigger cannot be detected in most cases. Regarding SARS-CoV-2, epidemiological studies have found no association with its development. Acute motor axonal neuropathy is the most common electrophysiological variant in Mexico and Asian countries. Intravenous immunoglobulin or plasma exchanges are still the treatment cornerstones. Mortality in Mexico can be as high as 12%. Advances in understanding the drivers of nerve injury in GBS that may provide the basis for developing targeted therapies have been made during the past decade; despite them, accurate criteria for selecting patients requiring acute treatment, prognostic biomarkers, and novel therapies are still needed. The newly-developed vaccines against SARS-CoV-2 have raised concerns regarding the potential risk for developing GBS. In the midst of coronavirus disease 2019 and vaccination campaigns against SARS-CoV-2, this review discusses the epidemiology, clinical presentation, management, and outcomes of GBS in Mexico.

[Moving toward personalized breast cancer screening: The role of Primary Care]. / Avances hacia el cribado personalizado del cáncer de mama: el papel de la Atención Primaria.

Breast cancer is the leading cause of death in the world among women. The Spanish National Health System (SNHS) introduced population-based breast cancer screening in 1990. As in most European programs, risk is identified on the basis of age and a mammogram is offered every two years to women aged 50-69 years. Scientific evidence is moving toward personalized screening, based on individual risk. This article presents the clinical trials that will evaluate the efficacy of personalized screening and some studies carried out in our environment on the effect of informing women of the benefits and adverse effects of screening or the acceptability and feasibility of offering personalized screening, in the Shared Decision Making context. The Preventive Activities and Health Promotion Program can help transform screening in our SNHS.

Neurofibromatosis type 1 families with first-degree relatives harbouring distinct NF1 pathogenic variants. Genetic counselling and familial diagnosis: what should be offered?

Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder caused by pathogenic variants in NF1 Recently, NF1 testing has been included as a clinical criterion for NF1 diagnosis. Additionally, preconception genetic counselling in patients with NF1 focuses on a 50% risk of transmitting the familial variant as the risk of having a sporadic NF1 is considered the same as the general population. METHODS: 829 individuals, 583 NF1 sporadic cases and 246 patients with NF1 with documented family history, underwent genetic testing for NF1. Genotyping and segregation analysis of NF1 familial variants was determined by microsatellite analysis and NF1 sequencing. RESULTS: The mutational analysis of NF1 in 154 families with two or more affected cases studied showed the co-occurrence of two different NF1 germline pathogenic variants in four families. The estimated mutation rate in those families was 3.89×10-3, 20 times higher than the NF1 mutation rate (~2×10-4) (p=0.0008). Furthermore, the co-occurrence of two different NF1 germline pathogenic variants in these families was 1:39, 60 times the frequency of sporadic NF1 (1:2500) (p=0.003). In all cases, the de novo NF1 pathogenic variant was present in a descendant of an affected male. In two cases, variants were detected in the inherited paternal wild-type allele. CONCLUSIONS: Our results, together with previous cases reported, suggest that the offspring of male patients with NF1 could have an increased risk of experiencing de novo NF1 pathogenic variants. This observation, if confirmed in additional cohorts, could have relevant implications for NF1 genetic counselling, family planning and NF1 genetic testing.

Pharmacokinetic modelling to predict risk of ototoxicity with intravenous tobramycin treatment in cystic fibrosis.

INTRODUCTION: Further optimization of therapeutic drug monitoring (TDM) for aminoglycosides (AGs) is urgently needed, especially in special populations such as those with cystic fibrosis (CF), >50% of whom develop ototoxicity if treated with multiple courses of IV AGs. This study aimed to empirically test a pharmacokinetic (PK) model using Bayesian estimation of drug exposure in the deeper body tissues to determine feasibility for prediction of ototoxicity. MATERIALS AND METHODS: IV doses (n = 3645) of tobramycin and vancomycin were documented with precise timing from 38 patients with CF (aged 8-21 years), including total doses given and total exposure (cumulative AUC). Concentration results were obtained at 3 and 10 h for the central (C1) compartment. These variables were used in Bayesian estimation to predict trough levels in the secondary tissue compartments (C2 trough) and maximum concentrations (C2max). The C1 and C2 measures were then correlated with hearing levels in the extended high-frequency range. RESULTS: Patients with more severe hearing loss were older and had a higher number of tobramycin C2max concentrations >2 mg/L than patients with normal or lesser degrees of hearing loss. These two factors together significantly predicted average high-frequency hearing level (r = 0.618, P < 0.001). Traditional metrics such as C1 trough concentrations were not predictive. The relative risk for hearing loss was 5.8 times greater with six or more tobramycin courses that exceeded C2max concentrations of 3 mg/L or higher, with sensitivity of 83% and specificity of 86%. CONCLUSIONS: Advanced PK model-informed analysis predicted ototoxicity risk in patients with CF treated with tobramycin and demonstrated high test prediction.

ATP1A3-related disorders in the differential diagnosis of acute brainstem and cerebellar dysfunction.

Alternating Hemiplegia of Childhood (AHC), Rapid-onset Dystonia-Parkinsonism (RDP), and CAPOS syndrome (Cerebellar ataxia, Areflexia, Pes cavus, Optic atrophy, and Sensorineural hearing loss) are all caused by mutations in the same gene: ATP1A3. Although initially they were considered separate disorders, recent evidence suggests a continuous clinical spectrum of ATP1A3-related disorders. At onset all these disorders can present with acute brainstem dysfunction triggered by a febrile illness. An infectious or autoimmune disorder is usually suspected. A genetic disorder is rarely considered in the first acute episode. We present three patients with ATP1A3 mutations: one patient with AHC, one patient with RDP, and one patient with CAPOS syndrome. We describe the acute onset and overlapping clinical features of these three patients with classical phenotypes. These cases highlight ATP1A3-related disorders as a possible cause of acute brainstem dysfunction with normal ancillary testing.

Evaluation of the Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection in children: Implications for screening in a school setting.

BACKGROUND: Rapid antigen tests hold much promise for use in the school environment. However, the performance of these tests in non-clinical settings and among one of the main target populations in schools-asymptomatic children-is unclear. To address this gap, we examined the positive and negative concordance between the BinaxNOW™ rapid SARS-CoV-2 antigen assay and an RT-PCR test among children at a community-based Covid-19 testing site. METHODS: We conducted rapid antigen (BinaxNOW™) and oral fluid RT-PCR (Curative Labs) tests on children presenting at a walk-up testing site in Los Angeles County from November 25, 2020 to December 9, 2020. Positive concordance was determined as the fraction of RT-PCR positive participants that were also antigen positive. Negative concordance was determined as the fraction of RT-PCR negative participants that were also antigen negative. Multivariate logistic regression models were used to examine the association between positive or negative concordance and participant age, race-ethnicity, sex at birth, symptoms and Ct values. RESULTS: 226 children tested positive on RT-PCR; 127 children or 56.2% (95% CI: 49.5% to 62.8%) of these also tested positive on the rapid antigen test. Positive concordance was higher among symptomatic children (64.4%; 95% CI: 53.4% to 74.4%) compared to asymptomatic children (51.1%; 95% CI: 42.5% to 59.7%). Positive concordance was negatively associated with Ct values and was 93.8% (95% CI: 69.8% to 99.8%) for children with Ct values less than or equal to 25. 548 children tested negative on RT-PCR; 539 or 98.4% (95% CI: 96.9% to 99.2%) of these also tested negative on the rapid antigen test. Negative concordance was higher among asymptomatic children. CONCLUSIONS: Rapid antigen testing can successfully identify most COVID infections in children with viral load levels likely to be infectious. Serial rapid testing may help compensate for limited sensitivity in early infection.

Circulating tumor DNA dynamics in advanced breast cancer treated with CDK4/6 inhibition and endocrine therapy.

Circulating tumor DNA (ctDNA) levels may predict response to anticancer drugs, including CDK4/6 inhibitors and endocrine therapy combinations (CDK4/6i+ET); however, critical questions remain unanswered such as which assay or statistical method to use. Here, we obtained paired plasma samples at baseline and week 4 in 45 consecutive patients with advanced breast cancer treated with CDK4/6i+ET. ctDNA was detected in 96% of cases using the 74-gene Guardant360 assay. A variant allele fraction ratio (VAFR) was calculated for each of the 79 detected mutations between both timepoints. Mean of all VAFRs (mVAFR) was computed for each patient. In our dataset, mVAFR was significantly associated with progression-free survival (PFS). Baseline VAF, on-treatment VAF or absolute changes in VAF were not associated with PFS, nor were CA-15.3 levels at baseline, week 4 or the CA-15.3 ratio. These findings demonstrate that ctDNA dynamics using a standardized multi-gene panel and a unique methodological approach predicts treatment outcome. Clinical trials in patients with an unfavorable ctDNA response are needed.

Congenital cutaneous neurofibromas in neurofibromatosis type 1: Clinicopathological features in early infancy.

BACKGROUND AND OBJECTIVE: Clinicopathological features of cutaneous neurofibromas presenting as large irregularly shaped congenital café-au-lait macules (CALM) in Neurofibromatosis type 1 (NF1) patients have not been well characterized. We aimed to analyze the histopathological findings of large "atypical" CALM in children with NF1. PATIENTS AND METHODS: In this retrospective observational study we analyzed histopathological and immunostaining features of 21 biopsy specimens from 18 large hyperpigmented macules with irregular borders with or without hypertrichosis present during the first months of life in NF1 diagnosed children. RESULTS: Of the 21 biopsies, ten showed a diffuse neurofibroma pattern and four exhibited characteristics of plexiform neurofibroma (PNF). In twelve specimens we observed groups of fusiform cells arranged linearly mimicking a small caliber nerve trunk with abnormal morphology. Repeated biopsies from two of these lesions performed at different ages showed transformation to a plexiform pattern. An increased interstitial cellularity was observed in 17 samples that was more evident around eccrine glands in 16 or accompanying hair follicles and vascular structures in twelve samples. All these cells had immunoreactivity for S100-protein, CD68 and were Melan-A positive in 15 samples. CONCLUSION: Clinicopathological findings of congenital cutaneous neurofibromas provide early diagnostic clues of NF1 with high relevance for monitoring of these patients.

[Informed choice in breast cancer screening: the role of education]. / Elección informada en el cribado del cáncer de mama: el papel del nivel educativo.

OBJECTIVE: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. METHOD: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. RESULTS: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. CONCLUSIONS: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened.

Vacinação contra influenza no enfrentamento da COVID-19: integração ensino-serviço para formação em enfermagem e saúde / Vaccination against influenza in the face of COVID-19: teaching-service integration for training in nursing and health / Vacunación contra influenza en el enfrentamiento de la COVID-19: integración enseñanza-servicio para formación en enfermería y salud

Objetivo: descrever a experiência de integração ensino-serviço durante a primeira etapa da 22ª Campanha Nacional de Vacinação contra a Influenza na emergência da COVID-19. Método: relato de experiência sobre a parceria de um curso de enfermagem de uma das instituições de ensino superior de Ribeirão Preto-SP, Brasil, com serviços da Atenção Primária à Saúde na referida campanha, no período de março a abril de 2020. Resultados: essa parceria mobilizou diversos voluntários para implementar 35 postos volantes de vacinação, incluindo um drive-thru. Nessa primeira etapa, foram aplicadas 91.697 doses do imunobiológico em idosos, de um total de 98.189, que correspondeu a 83,3%, valor muito próximo da cobertura vacinal de 90% esperada para esse grupo populacional. Com a parceria, o número total de doses aplicadas em idosos ao final da 22a campanha, na cidade, superou em 42,6% a média dos últimos cinco anos. Conclusão e implicações para a prática: atribui-se esse percentual ao trabalho coletivo e multiprofissional e ao compromisso social das instituições envolvidas com a proteção da saúde, a preservação da vida e o fortalecimento do Sistema Único de Saúde.

Objective: to describe the experience of teaching-service integration during the first stage of the 22nd Brazilian National Influenza Vaccination Campaign in the emergence of COVID-19. Method: this is an experience report on the partnership of a nursing course from one of the higher education institutions in Ribeirão Preto-SP, Brazil, with Primary Health Care services in that campaign, from March to April 2020. Results: this partnership mobilized several volunteers to implement 35 vaccination stations, including a drive-thru. In this first stage, 91,697 doses of the immunobiological agent were applied to older adults, from a total of 98,189, which corresponded to 83.3%, a value very close to the 90% vaccination coverage expected for this population group. With the partnership, the total number of doses applied to older adults at the end of the 22nd campaign in the city exceeded the average of the last five years by 42.6%. Conclusion and implications for practice: this percentage is attributed to the collective and multiprofessional work and the social commitment of the institutions involved with protection of health, preservation of life and strengthening of the Unified Health System.

Objetivo: describir la experiencia de integración enseñanza-servicio durante la primera etapa de la 22ª Campaña Nacional de Vacunación contra el Influenza en la emergencia de la covid-19. Método: un relato de experiencia de la asociación de un curso de enfermería de una institución de enseñanza superior de Ribeirão Preto-SP, Brasil con servicios de la atención primaria a la salud en la referida campaña, en el período de marzo a abril de 2020. Resultados: esta asociación movilizó a varios voluntarios para implementar 35 estaciones de vacunación, incluyendo un drive-thru. En esa primera etapa, fueron aplicadas 91.697 dosis del inmunobiológico en ancianos, de un total de 98.189, que correspondió a 83,3%, valor muy próximo de la cobertura vacunal de 90% esperada para ese grupo poblacional. Con la asociación, el número total de dosis aplicadas en ancianos al final de la 22a campaña en la ciudad superó en 42,6% el promedio de los últimos cinco años. Conclusión e implicaciones para la práctica: este porcentaje se atribuye al trabajo colectivo e interprofesional y al compromiso social de las instituciones involucradas con la protección de la salud, la preservación de la vida y el fortalecimiento del Sistema Único de Salud.

Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial.

INTRODUCTION: Personalised cancer screening aims to improve benefits, reduce harms and being more cost-effective than age-based screening. The objective of the DECIDO study is to assess the acceptability and feasibility of offering risk-based personalised breast cancer screening and its integration in regular clinical practice in a National Health System setting. METHODS AND ANALYSIS: The study is designed as a single-arm proof-of-concept trial. The study sample will include 385 women aged 40-50 years resident in a primary care health area in Spain. The study intervention consists of (1) a baseline visit; (2) breast cancer risk estimation; (3) a second visit for risk communication and screening recommendations based on breast cancer risk and (4) a follow-up to obtain the study outcomes.A polygenic risk score (PRS) will be constructed as a composite likelihood ratio of 83 single nucleotide polymorphisms. The Breast Cancer Surveillance Consortium risk model, including age, race/ethnicity, family history of breast cancer, benign breast disease and breast density will be used to estimate a preliminary 5-year absolute risk of breast cancer. A Bayesian approach will be used to update this risk with the PRS value.The primary outcome measures will be attitude towards, intention to participate in and satisfaction with personalised breast cancer screening. Secondary outcomes will include the proportions of women who accept to participate and who complete the different phases of the study. The exact binomial and the Student's t-test will be used to obtain 95% CIs. ETHICS AND DISSEMINATION: The study protocol was approved by the Drug Research Ethics Committee of the University Hospital Arnau de Vilanova. The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki and Good Clinical Practice.The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media. TRIAL REGISTRATION NUMBER: NCT03791008.

Comissão de Análise de Solicitações Especiais: uma iniciativa fundamental no contexto da judicialização da saúde / Special Requests Analysis Committee: a key initiative in the context of health judicialization / Comisión de Análisis de Solicitudes Especiales: una iniciativa fundamental en el contexto de judicialización de la salud

RESUMO Objetivo Descrever e analisar o trabalho de Comissão Especial que avalia tecnicamente demandas judiciais em município do interior paulista brasileiro. Método Estudo de natureza qualitativa no qual foram realizadas sete entrevistas semiestruturadas, seguindo a técnica da bola de neve. Os dados discursivos foram interpretados tomando como referência alguns elementos da análise de conteúdo temática. Resultados Os entrevistados, integrantes da Comissão Especial, responderam perguntas referentes a quatro eixos temáticos pré-elaborados: a experiência de trabalho na judicialização, o processo saúde-doença, a responsabilidade do sistema de saúde no bem estar do usuário e o direito à saúde. No primeiro eixo, os entrevistados compartilharam sua rotina de trabalho, expuseram ferramentas utilizadas para emitir pareceres técnicos, reconheceram a relevância da Comissão para qualificar demandas, racionalizar gastos públicos e aproximar as áreas da Saúde e do Direito. No segundo eixo, destacaram a associação entre vários condicionantes e determinantes para ter saúde ou desenvolver doença. No terceiro, ressaltaram a importância da atenção integral para promover o bem-estar e diminuir agravos. No quarto, afirmaram que o direito à saúde não se refere somente ao acesso à assistência em saúde, a envolver também elementos individuais e coletivos que formam as pessoas, famílias e comunidades e que a efetivação do direito à saúde não é processo unilateral. Conclusão Segundo o material empírico, reconhecer as diversas questões, perspectivas, condições e opiniões relacionadas à judicialização pode auxiliar na sua compreensão global e oferecer possibilidades mais justas e racionais para a efetivação do direito à saúde pela via judicial.

ABSTRACT Objectives To describe and analyze the work of a Special Commission, which technically evaluates litigations in a municipality in the regional area of São Paulo, in Brazil. Method Qualitative study, in which seven semi-structured interviews were carried out following the snowball technique. The discursive data was analyzed taking as reference some elements of the thematic analysis. Results The members of the Special Commission interviewed, answered questions related to four pre-established thematic axes: the work experience in the judicialization, the health-disease process, the responsibility of the health system regarding the user's well-being, and the right to health. In the first axis, they shared their work routine, exposed the tools they use to issue technical opinions, and recognized the relevance of the Commission to qualify the demands, rationalize public spending and approximate the areas of Health and Law. In the second axis, they highlighted the association between several constraints and determinants to be healthy or to develop a disease. In the third, they emphasized the relevance of integral care to promote well-being and reduce worsening. In the fourth, they affirmed that the right to health is not restricted to access to health care, but to the individual and collective elements that conform people, families and communities, and that the realization of the right to health is not a unilateral process. Conclusion According to the empirical material, recognizing the different issues, perspectives, conditions and opinions related to the judicialization can help in its global comprehension and offer more just and rational possibilities for the realization of the right to health through the judicial process.

RESUMEN Objetivo Describir y analizar el trabajo de una Comisión Especial que evalúa técnicamente demandas judiciales en un municipio del interior paulista brasileño. Método Estudio de naturaleza cualitativa, en el cual se realizaron siete entrevistas semiestructuradas siguiendo la técnica de la bola de nieve. Los datos discursivos fueron interpretados tomando como referencia algunos elementos del análisis de contenido temático. Resultados Los entrevistados, integrantes de la Comisión Especial, respondieron preguntas relacionadas a los cuatro ejes temáticos preelaborados: la experiencia de trabajo en la judicialización, el proceso salud-enfermedad, la responsabilidad del sistema de salud en el bienestar del usuario y el derecho a la salud. En el primer eje, los entrevistados compartieron su rutina de trabajo, expusieron herramientas utilizadas para emitir dictámenes técnicos y reconocieron la relevancia de la Comisión para calificar demandas, racionalizar gastos públicos y acercar las áreas de Salud y del Derecho. En el segundo eje, destacaron la asociación entre varios condicionantes y determinantes para tener salud y desarrollar una enfermedad. En el tercero, resaltaron la importancia de la atención integral para promover el bienestar y disminuir agravamientos. En el cuarto, afirmaron que el derecho a la salud no se refiere solamente al acceso a la asistencia en salud, involucrando también elementos individuales y colectivos que forman a las personas, familias y comunidades y que la efectuación del derecho a la salud no es un proceso unilateral. Conclusión Según el material empírico, reconocer las diversas cuestiones, perspectivas, condiciones y opiniones relacionadas con la judicialización puede auxiliar en su comprensión global y ofrecer posibilidades más justas y racionales para la efectuación del derecho a la salud por la vía judicial.