RESUMO
BACKGROUND: One strategy to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in patients with breast cancer, usually a few weeks after starting chemotherapy, on an outpatient basis 2 to 3 times a week. The main differences in our study are that we carried out physical training in hospitalized patients undergoing a cycle of chemotherapy for cancer treatment and that this training was carried out 5 times a week and was not restricted to a specific type of cancer. OBJECTIVE: We aimed to evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia, and sensation of weakness), fatigue, mobility, clinical complications, and length of hospital stay of patients during the drug treatment cycle. We also evaluated patient satisfaction with the proposed intervention, the adverse effects of aerobics training, and the cost-effectiveness of this intervention. METHODS: This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized patients with cancer for 1 or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using a linear mixed model for fatigue, mobility, and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the χ2 test. Cost-effectiveness and cost-utility analyses will be performed for the impact of exercise and quality-adjusted life years with the EQ-5D-3L-21 quality of life trials. The implementation variables (acceptability, suitability, and feasibility) will be evaluated by frequencies. RESULTS: The clinical trial registration was approved in March 2023. Recruitment and data collection for the trial are ongoing, and the results of this study are likely to be published in late 2025. CONCLUSIONS: Chemotherapy has side effects that negatively impact the quality of life of patients with cancer. Aerobic exercise can reduce these side effects in a simple and inexpensive way. The field of work of physical therapists could be expanded to oncology if the intervention works. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos RBR-6b4zwx3; https://tinyurl.com/39c4c7wz. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60828.
Assuntos
Análise Custo-Benefício , Humanos , Feminino , Neoplasias/tratamento farmacológico , Exercício Físico , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Antineoplásicos/economia , Terapia por Exercício/economia , Terapia por Exercício/métodos , Masculino , Adulto , Pessoa de Meia-Idade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Qualidade de Vida , IdosoRESUMO
OBJECTIVES: To estimate the proportion of patients with drug-related morbidities (DRMs), DRM preventability, and the cost of illness of the DRMs in Brazil. METHODS: We used the decision-analytic model initially developed by Johnson and Bootman (Drug-related morbidity and mortality. A cost-of-illness model. J Manag Care Pharm 1996;2:39-47), which was adapted to the reality of the present study. A hypothetical cohort of patients in ambulatory care setting was simulated considering the perspective of the Brazilian public health system. Direct costs related to health care were obtained from the national databases, and the probability of occurrence of DRMs was established by a panel of clinical experts. Sensitivity analyses were conducted. RESULTS: An estimated 59% ± 14% of all patients assisted by the health system suffer some DRMs. Given these cases, 53% ± 18% were considered preventable. The average cost of managing a patient with any DRM was US $155. The cost of illness of the DRMs in Brazil would account for nearly US $18 billion (US $9-$27 billion) (best and worst case scenarium) annually. This amount is 5 times higher than what the Ministry of Health spends to guarantee free medicines in Brazil. Hospitalizations and long-term stays in hospital correspond to 75% of this cost. The sensitivity analysis showed that the model is sensitive to variations in these two outcomes. CONCLUSIONS: According to the model, a large proportion of patients experience DRM and the economic impact to solve these problems is substantial for the health system. Considering that more than half of these cases are preventable, it could be possible to achieve an enormous saving of resources through actions that improve the process of medication use.
Assuntos
Efeitos Psicossociais da Doença , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Morbidade , Brasil/epidemiologia , Técnicas de Apoio para a Decisão , Custos de Cuidados de Saúde , Hospitalização/economia , Humanos , Modelos EconômicosRESUMO
OBJECTIVES: To estimate the cost of managing drug-related morbidity (DRM) that leads to visits to the emergency department of a Brazilian hospital. METHODS: This is a cost-of-illness study based on a retrospective cross-sectional analysis of patients' medical records. A questionnaire and analysis of medical records were used to identify patients who were being admitted to the emergency department because of DRM. The direct medical costs of patient management were estimated using a microcosting analysis, and a sensitivity analysis was conducted using the emergency department visit rates due to DRM reported in the literature. RESULTS: Of the total patients interviewed, 14.6% sought emergency care because of DRM and 58.9% were considered preventable. Mean treatment costs were US $900 ± $1,569 (range US $18-$10,847). An extrapolation based on all emergency visits in the last year resulted in annual total treatment costs of US $7.5 million (US $1.1-$1.4 million). It was observed that 39.3% of the total cost of DRM was attributed to adverse drug reactions, 36.9% to nonadherence to treatment, and 16.9% to incorrect dosages. CONCLUSIONS: Adverse drug reactions and nonadherence to treatment are important causes of morbidity and cost to the health service. Much of this resource is spent to treat preventable cases of DRM, which represents a great waste of resources.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Morbidade , Brasil , Estudos Transversais , Serviço Hospitalar de Emergência/economia , Feminino , Hospitalização/economia , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
BACKGROUND: Serious adverse events during hospital care are a worldwide reality and threaten the safety of the hospitalised patient. OBJECTIVE: To identify serious adverse events related to healthcare and direct hospital costs in a Teaching Hospital in México. MATERIAL AND METHODS: A study was conducted in a 250-bed Teaching Hospital in San Luis Potosi, Mexico. Data were obtained from the Quality and Patient Safety Department based on 2012 incidents report. Every event was reviewed and analysed by an expert team using the "fish bone" tool. The costs were calculated since the event took place until discharge or death of the patient. RESULTS: A total of 34 serious adverse events were identified. The average cost was $117,440.89 Mexican pesos (approx. 7,000). The great majority (82.35%) were largely preventable and related to the process of care. Undergraduate medical staff were involved in 58.82%, and 14.7% of patients had suffered adverse events in other hospitals. CONCLUSIONS: Serious adverse events in a Teaching Hospital setting need to be analysed to learn and deploy interventions to prevent and improve patient safety. The direct costs of these events are similar to those reported in developed countries.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Custos Hospitalares , Hospitais de Ensino/economia , Erros Médicos/economia , Adulto , Feminino , Humanos , Masculino , México , Segurança do PacienteRESUMO
CONTEXT AND OBJECTIVES: Adverse drug reactions (ADRs) may cause prolonged hospital admissions with high treatment costs. The burden of ADRs in children has never been evaluated in Nigeria. The incidence of pediatric ADRs and the estimated cost of treatment over an 18-month period were determined in this study. DESIGN AND SETTING: Prospective observational study on children admitted to the pediatric wards of the Lagos State University Teaching Hospital (LASUTH) in Nigeria, between July 2006 and December 2007. METHODS: Each patient was assessed for ADRs throughout admission. Medical and non-medical costs to the hospital and patient were estimated for each ADR by reviewing the medical and pharmacy bills, medical charts and diagnostic request forms and by interviewing the parents. Cost estimates were performed in 2007 naira (Nigeria currency) from the perspectives of the hospital (government), service users (patients) and society (bearers of the total costs attributable to treating ADRs). The total estimated cost was expressed in 2007 United States dollars (USD). RESULTS: Two thousand and four children were admitted during the study; 12 (0.6%) were admitted because of ADRs and 23 (1.2%) developed ADR(s) during admission. Forty ADRs were suspected in these 35 patients and involved 53 medicines. Antibiotics (50%) were the most suspected medicines. Approximately 1.83 million naira (USD 15,466.60) was expended to manage all the patients admitted due to ADRs. CONCLUSIONS: Treating pediatric ADRs was very expensive. Pediatric drug use policies in Nigeria need to be reviewed so as to discourage self-medication, polypharmacy prescription and sales of prescription medicines without prescription.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Custos Hospitalares , Distribuição por Idade , Criança , Pré-Escolar , Custos Diretos de Serviços , Honorários e Preços , Feminino , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Hospitais de Ensino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Nigéria/epidemiologia , Estudos Prospectivos , Distribuição por SexoRESUMO
CONTEXT AND OBJECTIVES: Adverse drug reactions (ADRs) may cause prolonged hospital admissions with high treatment costs. The burden of ADRs in children has never been evaluated in Nigeria. The incidence of pediatric ADRs and the estimated cost of treatment over an 18-month period were determined in this study. DESIGN AND SETTING: Prospective observational study on children admitted to the pediatric wards of the Lagos State University Teaching Hospital (LASUTH) in Nigeria, between July 2006 and December 2007. METHODS: Each patient was assessed for ADRs throughout admission. Medical and non-medical costs to the hospital and patient were estimated for each ADR by reviewing the medical and pharmacy bills, medical charts and diagnostic request forms and by interviewing the parents. Cost estimates were performed in 2007 naira (Nigeria currency) from the perspectives of the hospital (government), service users (patients) and society (bearers of the total costs attributable to treating ADRs). The total estimated cost was expressed in 2007 United States dollars (USD). RESULTS: Two thousand and four children were admitted during the study; 12 (0.6 percent) were admitted because of ADRs and 23 (1.2 percent) developed ADR(s) during admission. Forty ADRs were suspected in these 35 patients and involved 53 medicines. Antibiotics (50 percent) were the most suspected medicines. Approximately 1.83 million naira (USD 15,466.60) was expended to manage all the patients admitted due to ADRs. CONCLUSIONS: Treating pediatric ADRs was very expensive. Pediatric drug use policies in Nigeria need to be reviewed so as to discourage self-medication, polypharmacy prescription and sales of prescription medicines without prescription.
CONTEXTO E OBJETIVOS: Reações adversas a drogas (RAD) podem causar hospitalização prolongada com alto custo de tratamento. Este efeito das RAD em crianças nunca foi avaliado na Nigéria. A incidência de RAD em pediatria e o custo estimado de tratamento em um período de 18 meses foram determinadas neste estudo. DESENHO E LOCAL: Estudo prospectivo observacional de crianças admitidas nas unidades pediátricas do Hospital Universitário do Estado de Lagos (LASUTH) na Nigéria, entre julho de 2006 e dezembro de 2007. MÉTODOS: Cada paciente foi avaliado para RAD durante a admissão. Os custos médicos e não médicos para o hospital e para o paciente foram estimados para cada RAD pela revisão das contas médicas e da farmácia, pelos registros médicos, pelos exames necessários para diagnóstico e pelas entrevistas com os pais. Os custos foram estimados em nairas (moeda nigeriana) de 2007 a partir das perspectivas do hospital (governo), dos usuários de serviços (pacientes) e da sociedade (portadores dos custos totais atribuídos ao tratamento de RAD). A estimativa de custo total foi apresentada em dólares americanos (US) de 2007. RESULTADOS: Duas mil e quatro crianças foram admitidas durante este estudo; 12 (0,6 por cento) foram admitidas devido a RAD e 23 (1.2 por cento) desenvolveram RAD durante admissão. Quarenta RAD foram suspeitadas nesses 35 pacientes e envolveram 53 medicamentos. Antibióticos (50 por cento) foram as drogas mais suspeitas. Aproximadamente 1.83 milhões de nairas (US 15,466.60) foram gastos para cuidar de todos os pacientes admitidos por RAD. CONCLUSÕES: O tratamento das RAD pediátricas foi bastante caro. As políticas de uso de drogas em pediatria na Nigéria devem ser revistas para desencorajar a auto-medicação, a prescrição de polifarmácia e a venda de medicamentos de prescrição sem prescrição.
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Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Custos Hospitalares , Distribuição por Idade , Custos Diretos de Serviços , Honorários e Preços , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Hospitais de Ensino , Incidência , Nigéria/epidemiologia , Estudos Prospectivos , Distribuição por SexoRESUMO
INTRODUCTION: Implementing pharmacovigilance activities consists of monitoring and assessment of activities related to medical attention. However, additional data are necessary to identify conditions where care quality can be improved. Therefore, a focus on adverse drug events analysis from a prevention and economic perspective is needed, with emphasis on its local impact. OBJECTIVE: Preventable adverse drug events were summarized to establishing their impact on morbidity and mortality, as well as to estimate the ensuing economic burden. MATERIALS AND METHODS: The data were gathered from a level 3 hospital (high complexity), located in Bogotá, Colombia, where specific pharmacovigilance activities were recorded in 2007. Patient charts were reviewed to characterize adverse drug events according to their causality, severity and preventability. Direct costs were estimated by grouping diagnostic tests, length of hospitalization, procedures and additional drugs required. RESULTS: The charts of 283 patients and 448 reports were analyzed. These data indicated that 24.8% of adverse drug events were preventable and that an associated mortality of 1.1% had occurred. The associated direct costs were between USD $16,687 and $18,739. Factors more commonly associated with preventability were drug-drug interactions, as well as inappropriate doses and unsuitable frequencies at which the drugs were administrated. CONCLUSIONS: The data recommended that actions be taken to decrease preventable adverse drug events, because of negative impact on patient´s health, and unnecessary consumption of healthcare resources.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Gastos em Saúde/estatística & dados numéricos , Custos Hospitalares/estatística & dados numéricos , Hospitais Universitários/economia , Centros de Atenção Terciária/economia , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Causalidade , Colômbia/epidemiologia , Custos e Análise de Custo , Testes Diagnósticos de Rotina/economia , Custos de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Feminino , Mortalidade Hospitalar , Registros Hospitalares/estatística & dados numéricos , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Estudos Retrospectivos , Índice de Gravidade de Doença , Adulto JovemRESUMO
INTRODUCTION: Adverse drug reactions (ADRs) occur frequently in hospitals and increase costs of health care; however, few studies have quantified the clinical and economic impact of ADRs in Colombia. OBJECTIVES: These impacts were evaluated by calculating costs associated with ADRs in patients hospitalized in the internal medicine ward of a Level 3 hospital located in Bogotá, Colombia. In addition, salient clinical features of ADRs were identified and characterized. MATERIAL AND METHODS: Intensive follow-ups for a cohort of patients were conducted for a five month period in order to detect ADRs; different ways to classify them, according to literature, were considered as well. Information was collected using the INVIMA reporting format, and causal probability was evaluated with the Naranjo algorithm. Direct costs were calculated from the perspective of payer, based on the following costs: additional hospital stay, medications, paraclinical tests, additional procedures, patient displacement to intermediate or intensive care units, and other costs. RESULTS: Of 836 patients admitted to the service, 268 adverse drug reactions were detected in 208 patients (incidence proportion 25.1%, occurence rate 0.32). About the ADRs found, 74.3% were classified as probable, 92.5% were type A, and 81.3% were moderate. The body system most often affected was the circulatory system (33.9%). Drugs acting on the blood were most frequently those ones associated with adverse reactions (37.6%). The costs resulting from medical care of adverse drug reactions varied from COL dollar 93,633,422 (USD dollar 35,014.92) to COL dollar 122,155,406 (USD dollar 45,680.94), according to insurance type, during the study period. CONCLUSIONS: Adverse drug reactions have a significant negative health and financial impact on patient welfare. Because of the substantial resources required for their medical care and the significant proportion of preventable adverse reactions, active programs of institutional pharmacovigilance are highly recommended.