Sobrevida, qualidade de vida e sintomas de pacientes com doença renal crônica em seguimento pré-dialítico: ensaio clínico randomizado controlado e não cego após implantação do serviço de cuidados paliativos
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Data
2023-01-23
Autores
Rocha, Érica Pires da [UNESP]
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Universidade Estadual Paulista (Unesp)
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Diante do aumento da expectativa de vida, houve também o aumento das doenças crônicas como a Hipertensão Arterial Sistêmica (HAS) e o Diabetes Melitus (DM), principais etiologias da Doença Renal Crônica (DRC). Os pacientes com DRC, em estágio pré-dialítico, geralmente referem múltiplos sintomas o que impacta negativamente em piora da qualidade de vida. Portanto, a abordagem clínica, espiritual e social é um importante componente na qualidade do cuidado integral do portador de DRC pré-dialítica. Objetivos: Estudar os benefícios dos CP quando implantados precocemente junto aos pacientes renais crônicos em tratamento conservador (pré-diálise) quanto aos sintomas, qualidade de vida e sobrevida. Metodologia: Foi realizado ensaio clínico randomizado controlado e não cego com pacientes seguidos no ambulatório de pré-diálise (estágio 4 e 5) do HC da FMB - UNESP de junho de 2019 a dezembro de 2021. Foram excluídos pacientes com tempo de seguimento > 2 meses no ambulatório de pré-diálise, os que já seguiam previamente com a especialidade de cuidados paliativos, os que não aceitaram participar do estudo e os que iniciaram diálise ou foram a óbito no primeiro mês de seguimento. Os pacientes foram randomizados em dois grupos: Grupo controle - constituído por pacientes acompanhados no ambulatório de pré-diálise com os cuidados tradicionais na Nefrologia; Grupo intervenção - constituído por pacientes seguidos no ambulatório de pré-diálise que além dos cuidados tradicionais fornecidos pela nefrologia no ambulatório de pré-diálise também foram acompanhados, conjuntamente, pela equipe especializada em CP. Ambos os grupos foram avaliados e comparados no tempo zero quanto a: Doença de base, Idade, Comorbidades, Exames laboratoriais, Qualidade de vida, e Sintomas. Foram seguidos a cada 30-60 dias pelo ambulatório de pré-diálise para seguimento clínico e pelo menos a cada 90-120 dias no ambulatório de cuidados paliativos. Realizaram seguimento por 12 meses e reavaliados a cada seis meses quanto aos desfechos: controle de sintomas, qualidade de vida, evolução para a diálise e tempo para início do tratamento dialítico, número e dias de hospitalizações, sobrevida. Em todos os testes realizados, foi considerado o nível de significância de 5%. As comparações das variáveis contínuas foram realizadas utilizando o teste t Student para dados com distribuição normal e teste de Mann-Whitney para dados não normais. Para a análise comparativa das variáveis categóricas, foram usados os testes do Qui-Quadrado. As variáveis contínuas de medidas repetidas (qualidade de vida e exames laboratoriais) foram analisadas pelo modelo linear misto de efeitos randômicos. Para as análises das variáveis ordinais (sintomas) foi utilizado o modelo de medidas de Poisson para medidas repetidas com efeitos randômicos. Para os preditores foram considerados o momento da avaliação (basal, 6 e 12 meses) e os grupos bem como a interação entre eles. Para a variáveis randômicas foi considerado um slope variável para cada caso individual. A análise foi realizada com o software R versão 4.1.2 e o pacote lmer. Resultados: Foram randomizados em dois grupos um total de 32 pacientes incidentes no ambulatório de pré-diálise (grupo controle; grupo intervenção). Os sintomas foram comparados entre os grupos em três momentos no período de um ano (0,6,12 meses), com redução dos sintomas de tristeza e constipação na evolução do grupo intervenção. Não houve diferença entre os grupos em relação a qualidade de vida e exames laboratoriais. Conclusão: Este estudo ao avaliar o papel da abordagem dos cuidados paliativos na população pré-dialítica, mostrou a redução dos sintomas de constipação e tristeza nos pacientes com DRC em seguimento pré dialítico, sugerindo que a abordagem conjunta do cuidado paliativo pode resultar em melhor controle dos sintomas e da qualidade de vida dos pacientes.
In view of an increase in life expectancy, there has also been an increase in chronic diseases such as Systemic Arterial Hypertension (SAH) and diabetes mellitus (DM), the main causes of chronic kidney disease (CKD). Pre-dialysis CKD patients usually report multiple symptoms, which have a negative impact on their quality of life. For this reason, approaching the clinical, spiritual and social aspects is an important component of the quality of comprehensive care of pre-dialysis CKD patients. Goals: to study the benefits of Palliative Care (PC) when implemented early in chronic kidney patients undergoing conservative treatment (pre-dialysis) regarding symptoms, quality of life and survival. Methodology: A non-blind, controlled randomized clinical trial was conducted with patients followed up at the pre-dialysis outpatient clinic (stage 4-5) of HC of FMB- UNESP from June 2019 to December 2021. Patients followed up for more than two months in the pre-dialysis outpatient clinic were excluded from the trial, as were those previously followed up by the specialty of palliative care, those who did not agree to participate in the trial and those who started dialysis or died on the first month of follow-up. Patients were randomized into two groups: 1) Control group- made up by patients followed up at the pre-dialysis outpatient clinic who received traditional nephrology care; 2) Treatment group- made up by patients followed up at the predialysis outpatient clinic, who, besides receiving the traditional care provided by nephrology in the pre-dialysis outpatient clinic, were jointly followed by the team specialized in PC. Both groups were assessed and compared at time zero concerning: Underlying disease, age, comorbidities, laboratory tests, quality of life and symptoms They were followed up every 30-60 days by the pre-dialysis outpatient clinic for clinical follow-up and at least every 90-120 days in the palliative care outpatient clinic. They were followed up for 12 months and reassessed every six months regarding the following outcomes: control of symptoms, quality of life, progress to dialysis and time to initiate dialysis, number of hospital admissions and days in hospital, and survival. In all tests performed, a significance level of 5% was considered. Comparison of continuous variables was performed using the t Student test for data with normal distribution and the Mann-Whitney test for non-normal data. Chi-square tests were used for comparative analysis of categorical variables. Continuous variables of repeated measures (quality of life and lab tests) were analyzed through the linear mixed model of random effects. For the assessment or ordinal variables (symptoms), the Poisson measure model was used for repeated measures with random effects. Time of assessment (basal, six and twelve months) and groups, as well as interaction among them were considered predictors. A variable slope for each individual case was considered for random variables. Analysis was performed using the R software, version 4.1.2 and the ImerTest package. Results: a total of 32 patients were randomized into two groups at the pre-dialysis outpatient clinic (control group and treatment group). Symptoms were compared between the groups for a year at three moments (zero, six, and twelve months), with reduction of symptoms of depression and constipation in the evolution of the treatment group. There was no difference between the groups regarding quality of life and lab tests. Conclusion: when assessing the role of the palliative care approach in the pre-dialysis population, the current trial showed a reduction in symptoms of constipation and depression in CKD patients in pre-dialysis follow-up. This suggests that the joint approach to palliative care may result in better control of symptoms and better quality of life for these patients.
In view of an increase in life expectancy, there has also been an increase in chronic diseases such as Systemic Arterial Hypertension (SAH) and diabetes mellitus (DM), the main causes of chronic kidney disease (CKD). Pre-dialysis CKD patients usually report multiple symptoms, which have a negative impact on their quality of life. For this reason, approaching the clinical, spiritual and social aspects is an important component of the quality of comprehensive care of pre-dialysis CKD patients. Goals: to study the benefits of Palliative Care (PC) when implemented early in chronic kidney patients undergoing conservative treatment (pre-dialysis) regarding symptoms, quality of life and survival. Methodology: A non-blind, controlled randomized clinical trial was conducted with patients followed up at the pre-dialysis outpatient clinic (stage 4-5) of HC of FMB- UNESP from June 2019 to December 2021. Patients followed up for more than two months in the pre-dialysis outpatient clinic were excluded from the trial, as were those previously followed up by the specialty of palliative care, those who did not agree to participate in the trial and those who started dialysis or died on the first month of follow-up. Patients were randomized into two groups: 1) Control group- made up by patients followed up at the pre-dialysis outpatient clinic who received traditional nephrology care; 2) Treatment group- made up by patients followed up at the predialysis outpatient clinic, who, besides receiving the traditional care provided by nephrology in the pre-dialysis outpatient clinic, were jointly followed by the team specialized in PC. Both groups were assessed and compared at time zero concerning: Underlying disease, age, comorbidities, laboratory tests, quality of life and symptoms They were followed up every 30-60 days by the pre-dialysis outpatient clinic for clinical follow-up and at least every 90-120 days in the palliative care outpatient clinic. They were followed up for 12 months and reassessed every six months regarding the following outcomes: control of symptoms, quality of life, progress to dialysis and time to initiate dialysis, number of hospital admissions and days in hospital, and survival. In all tests performed, a significance level of 5% was considered. Comparison of continuous variables was performed using the t Student test for data with normal distribution and the Mann-Whitney test for non-normal data. Chi-square tests were used for comparative analysis of categorical variables. Continuous variables of repeated measures (quality of life and lab tests) were analyzed through the linear mixed model of random effects. For the assessment or ordinal variables (symptoms), the Poisson measure model was used for repeated measures with random effects. Time of assessment (basal, six and twelve months) and groups, as well as interaction among them were considered predictors. A variable slope for each individual case was considered for random variables. Analysis was performed using the R software, version 4.1.2 and the ImerTest package. Results: a total of 32 patients were randomized into two groups at the pre-dialysis outpatient clinic (control group and treatment group). Symptoms were compared between the groups for a year at three moments (zero, six, and twelve months), with reduction of symptoms of depression and constipation in the evolution of the treatment group. There was no difference between the groups regarding quality of life and lab tests. Conclusion: when assessing the role of the palliative care approach in the pre-dialysis population, the current trial showed a reduction in symptoms of constipation and depression in CKD patients in pre-dialysis follow-up. This suggests that the joint approach to palliative care may result in better control of symptoms and better quality of life for these patients.
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Palavras-chave
Nefrologia, Tratamento conservador, Tratamento paliativo, Insuficiência renal crônica, Qualidade de vida, Sobrevida