New embracing approach for better advanced cancer patient comprehensive care / Nuevo enfoque para mejorar el cuidado integral del paciente con cáncer avanzado

Abstract Introduction: Cancer patients have multiple and complex needs. Argentina has a medium-high cancer in cidence. Only 14% of patients with palliative care needs have access to specialized services. This study aimed to develop and implement an integrated cancer care model in three hospitals and at home based care level. Methods: The NECPAL2 was a prospective longitudi nal observational study. We report a two-year health care intervention and its implementation process. The NECPAL tool was used as a screening instrument. Adult cancer patients were recruited and assessed. NECPAL+ patients are those with a positive surprise question - Would you be surprised if this patient dies in the next year? (no)- and, at least one indicator of advanced disease. Patients were reassessed periodically with validated scales. Feedback was given for clinical case management. The project was developed in three consecutive stages and six phases. Data were collected for statistical analysis with a prognosis and palliative approach. Results: 2104 cancer patients screened. 681 were NECPAL+. 21% of them presented more than six pa rameters of severity or progression. The mean general survival was 8 months. 61.9% died within the follow-up period. Survival predictors were identified. Over 65% of patients were referred to palliative care; 10% received home-care. Areas for improvement were recognized. An implementation document was created. Discussion: This study showed that a predictive model is feasible, improving chances for timely referral and needs approach. It provided the basis for further implementation research and should encourage policy makers for embracing palliative model development for better cancer patient care.

Resumen Introducción: Los pacientes con cáncer tienen necesi dades múltiples y complejas que se deben atender opor tunamente en los distintos niveles del sistema sanitario. Argentina tiene una incidencia de cáncer media-alta pero solo el 14% de los pacientes acceden a cuidados paliativos. El objetivo de este estudio fue desarrollar e implementar un modelo multicéntrico de atención integral del paciente con cáncer avanzado. Métodos: El NECPAL2 fue un estudio observacional longitudinal prospectivo de dos años. Se evaluaron pacientes adultos con cáncer avanzado. Se utilizó la herramienta NECPAL como instrumento de cribado. Los pacientes NECPAL+ son aquellos con la pregunta sorpre sa positiva -¿Le sorprendería que este paciente muriera en el próximo año? (no)- y, al menos, un indicador de enfermedad avanzada. Los pacientes fueron reevaluados periódicamente con escalas validadas para la gestión clínica de casos. El proyecto se desarrolló en tres etapas consecutivas y seis fases. Se analizaron los resultados con un enfoque pronóstico y paliativo. Resultados: Se identificaron 2104 pacientes oncológicos, 681 eran NECPAL+. El 21% presentaba más de seis paráme tros de gravedad o progresión. Más del 60% de los pacientes NECPAL+ tenían una evaluación inicial multidimensional completa y documentada. La supervivencia media general fue de 8 meses. El 61.9% falleció durante el periodo de seguimiento. Se identificaron predictores de supervivencia. Más del 65% fueron derivados a cuidados paliativos; el 10% recibió atención domiciliaria. Se reconocieron áreas de mejora. Se creó un documento de recomendaciones. Discusión: Este estudio demostró que un modelo predictivo multicéntrico y en varios niveles es factible y mejora las posibilidades de derivación oportuna para atención paliativa. A pesar de las limitaciones este es tudio puede inspirar políticas para mejorar la atención integral de pacientes con cáncer avanzado.

Cross-cultural adaptation and semantic validation of an instrument to identify palliative requirements in Portuguese / Adaptação transcultural e validação semântica de instrumento para identificação de necessidades paliativas em língua portuguesa

ABSTRACT Objective To translate and make cross-cultural adaptation of NECPAL CCOMS-ICO© tool to Portuguese, and to analyze its semantic validity. Methods A methodological research about NECPAL CCOMS-ICO© tool cross-cultural adaptation, translated from Spanish into Portuguese and measurement of semantic validity. The cross-cultural adaptation process was conducted according to Beaton recommendations, including translation, translation synthesis, back-translation, and analysis of semantic, idiomatic, conceptual, and cultural equivalence of translated and back-translated tool versions, resulting in a pre-final version, which was submitted to a pre-test (n=35). Contend Validity Index was calculated to analyze semantic validity. Results Cross-cultural adaptation process allowed us to prepare the final version of this tool, which was named NECPAL-BR. Collected data from pre-testing step enabled the analysis of semantic validity. The Content Validity Index observed at this step was 0.94. Conclusion The semantic validity of the tool in its Portuguese version was confirmed; therefore, it may assist in screening chronic progressive disease patients, aiming to provide early palliative care. It may also be used to develop clinical and team performance indicators, and be employed as a care management tool designed to optimize resources.

RESUMO Objetivo Realizar a tradução e a adaptação transcultural, e analisar a validade semântica do instrumento NECPAL CCOMS-ICO© para a língua portuguesa. Métodos Pesquisa metodológica, de adaptação transcultural da versão espanhola do instrumento para a língua portuguesa e mensuração da validade semântica. Conduziu-se a adaptação transcultural com base nas recomendações de Beaton, que inclui tradução, síntese da tradução, retrotradução, e análise da equivalência semântica, idiomática, conceitual e cultural das versões, resultando na versão pré-final, a qual foi submetida ao pré-teste (n=35). Para analisar a validade semântica, foi calculado o Índice de Validade de Conteúdo. Resultados O processo de adaptação transcultural possibilitou a elaboração da versão final, denominada NECPAL-BR. Os dados do pré-teste possibilitaram a análise da validade semântica. O Índice de Validade de Conteúdo obtido nessa etapa foi de 0,94. Conclusão O instrumento possui validade semântica em sua versão em língua portuguesa e, portanto, pode auxiliar na triagem de pacientes com doença crônica progressiva, com vistas a oferecer, de forma precoce, atenção paliativa. Pode, ainda, propiciar o desenvolvimento de indicadores clínicos, de desempenho de equipe e servir como ferramenta de gestão do cuidado, visando à otimização de recursos.

Prognostic factors in cancer patients with palliative needs identified by the NECPAL CCOMS-ICO© TOOL

The early identification of patients with palliative needs has shown benefits in terms of quality of life and treatment goals. No prospective methods have been applied in Argentina to identify palliative needs in cancer patients. The NECPAL tool combines the physician's own insight with objective indicators of disease progression and indicators of chronic advanced conditions. The aim of this study was to identify prognostic factors of mortality in hospitalized and ambulatory patients with cancer and palliative needs according to the NECPAL tool in a University Hospital in Buenos Aires city. Study variables were obtained by interviews with 10 physicians in charge of 317 patients with cancer over a 2-year follow-up period. A total of 183 patients with palliative needs were labelled as NECPAL+. Of these, 137 died after a median 4-month follow-up period. The death rate was 11% patients/month. The mortality was higher in inpatients during the first month (p < 0.003). In the multivariate model, the best predictors of mortality combining relevant indicators were: inpatients (HR 1.87; 95% CI 1.24-2.84; p = 0.003), initial diagnosis other than breast cancer (HR 2.04; 95% CI 1.23-3.40; p = 0.006), metastatic disease (HR 1.67; 95% CI 1.15-2.42; p = 0.007), functional deterioration (HR 1.95; 95% CI 1.28-2.97; p = 0.002), and malnutrition (HR 1.53; 95% CI 1.04-2.23; p = 0.02 9). The major breakthrough was the systematic prospective identification of palliative needs in cancer patients for the first time in Argentina. The NECPAL tool can improve the prediction of mortality in hospital settings.

La identificación temprana de pacientes con necesidades paliativas ha demostrado beneficios en términos de calidad de vida y objetivos de tratamiento. En Argentina no han sido aplicados métodos prospectivos para identificar necesidades paliativas en pacientes con cáncer. El NECPAL CCOMS-ICO © combina la percepción del médico con indicadores objetivos de progresión de enfermedades crónicas avanzadas y es útil para determinar la prevalencia de pacientes con necesidades paliativas en la población general. El objetivo fue identificar factores pronósticos de mortalidad en pacientes internados y ambulatorios con cáncer y necesidades paliativas según NECPAL en un Hospital Universitario de la ciudad de Buenos Aires. Las variables se obtuvieron mediante entrevistas a 10 médicos a cargo de 317 pacientes con cáncer y necesidades paliativas durante dos años de seguimiento. Los predictores de mortalidad en el modelo multivariado fueron: hospitalización (HR 1.87; IC 95% 1.24-2.84; p = 0.003), diagnóstico distinto de cáncer de mama (HR 2.04; IC 95% 1.23-3.40; p = 0.006), enfermedad metastá sica (HR 1.67; IC 95% 1.15-2.42; p = 0.007), deterioro funcional (HR 1.95; IC 95% 1.28-2.97; p = 0.002) y nutricional (HR 1.53; IC 95% 1.04-2.23; p = 0.029). De los 183 pacientes con necesidades paliativas identificados como NECPAL+, 137 murieron en un período medio de 4 meses. La tasa de mortalidad fue 11% por mes. La mortalidad fue mayor (p < 0.003) en el primer mes de hospitalización. El mayor logro fue la identificación sistemática y prospectiva, por primera vez en Argentina, de necesidades paliativas en pacientes con cáncer. La herramienta NECPAL puede mejorar la predicción de la mortalidad en entornos hospitalarios.