Strategies to Approach Medicines Litigation: An Action Research Study in Brazil.

Background: In the last decades, litigation has been increasingly used to access medicines in Brazil. This phenomenon has led to the development of diverse strategies to reduce its negative impact on the organization of pharmaceutical services. In spite of that, managers still face difficulties dealing with lawsuits. Objective: This study aims to report the planning and implementation of strategies to approach medicines litigation in a municipality located in the southeast region of Brazil. Methods: Mixed methods were employed through an action research cycle. A network coordination team included researchers from university and municipal managers. The scenario analysis comprised the characterization of pharmaceutical services and the profile of medicines lawsuits. Afterward, strategies were planned to deal with the central problem identified. The action plan involved educational outreach visits and distribution of printed materials for health professionals, evaluated through opinion survey. Group conversations were conducted with the users of the public health system, followed by thematic analysis of reports. Results: The characterization of pharmaceutical services in the municipality revealed that treatments supplied were in accordance with the National Medicines Policy. In addition, a sector was implemented to attend demands for non-incorporated medicines. In spite of the services available, the characterization of lawsuits indicated that the main claimants were users of the public health system, requiring non-incorporated medicines, with therapeutic alternatives available. Thus, educational outreach visits were held in 14 health units (23 physicians in total). Everyone who answered the evaluation declared that they were very satisfied with the approach. Group conversations with the users of the health system reached 227 participants in total. In regard to users' perception about pharmaceutical services, thematic analysis of reports identified three main categories including aspects related to medicines provided, users assisted, and quality of service. Conclusion: The study described the first cycle of an action research project to develop strategies to approach medicines litigation at the municipal level. The application of educational outreach visits for health professionals and group conversations with health system users is a promising approach to improve access to information about pharmaceutical services in Brazil.

High validity and reliability of the PedsQL™ Multidimensional Fatigue Scale for Brazilian children with cancer.

Among the main factors that affect patients' quality of life, fatigue is a significant symptom experienced by children during treatment. Despite the high incidence, there has been no validated scale to evaluate fatigue in children with cancer in Brazil. The purpose of this study was to examine the psychometric properties of the PedsQL™ Multidimensional Fatigue Scale, using self-reports of Brazilian children, 8 to 18 years of age, and proxy reports. A cross-sectional method was used to collect data from 216 subjects over an 18-month period. Reliability ranged from .70 to .90 except for sleep/rest fatigue, self-report (α = .55). No floor or ceiling effects were found in any dimension. Convergent validity was higher than .40 and divergent validity had 100% adjustment. The root mean square error of approximation was acceptable. The comparative fit index was lower than expected. The agreement between self and proxy responses was weak and moderate. The results demonstrate the reliability and validity of the Brazilian version in children with cancer. This is the first validated scale that assesses fatigue in Brazilian children and adolescents with cancer.

Validity of the DISABKIDS®-Cystic Fibrosis Module for Brazilian children and adolescents.

OBJECTIVES: To validate the health-related quality of life measuring instrument DISABKIDS®-Cystic Fibrosis Module (self version) for Brazilian children and adolescents. METHOD: Methodological study in which a sample of 113 participants (54 girls and 59 boys; mean age 11.91 years and SD=2.79) was considered, from four Brazilian states, São Paulo, Paraná, Minas Gerais and the Federal District, 51 of whom participated in the pilot study and 62 in the field study. The answers to the questionnaire were analyzed, considering the frequency distributions with regard to the floor and ceiling effects, Cronbach's Alpha statistics, Pearson's Linear Correlation Coefficient, Mulitrait-Multimethod analysis and Confirmatory Factor Analysis according to Structural Equations Modeling. RESULTS: The instrument showed a high internal consistency coefficient (verified using Cronbach's Alpha) and construct validity, according to the Multitrait-Multimethod analysis. The DISABKIDS®-Cystic Fibrosis Module, self version, maintained the same factorial structure as in the originally proposed model. CONCLUSION: The instrument validation has been finished and indicates that the self version is validated for use in Brazil and can be included into the monitoring routine of this population.

[Children and adolescents on hemodialysis: attributes associated with quality of life]. / Crianças e adolescents em hemodiálise: atributos associados à qualidade de vida.

OBJECTIVE: To identify quality of life impacting attributes related to health of children and adolescents with chronic renal failure,on hemodialysis, as initial step to build the specific module DISABKIDS®. METHOD: An Exploratory descriptive study, with qualitative approach, with data collected between August of 2011 to March of 2013, through focus group analysis, with 42 participants between 8 and 18 years, their parents and caregivers. The data analysis was conducted following the thematic content, using the program Qualitative Data Analysis Software. RESULTS: Seven themes were identified:water and food restrictions, limitations imposed by the treatment, time dedicated to treatment, change in body image related to the vascular access and growth,stigma, self-care and hope of kidney transplantation. CONCLUSION: Relevant aspects to the participants' experience regarding the disease and the treatment were apprehended, trying to understand how this process is associated to quality of life.

[Translation and cultural adaptation of the brazilian version of Disabkids® Atopic Dermatits Module (ADM)]. / Tradução e adaptação cultural para o Brasil do DISABKIDS® Atopic Dermatitis Module (ADM).

The objective of this study was to translate and make the cultural adaptation of the Brazilian version of the DISABKIDS® Atopic Dermatitis Module (ADM), an instrument used to measure the health-related quality of life of children and adolescents with atopic dermatitis. The instrument has 12 items answered using a Likert scale, with two versions: self and proxy. The study counted with a sample of 18 Brazilian children and adolescents with atopic dermatitis, of ages ranging between 8 and 18 years, and their respective parents or caregivers. The process involved the following steps of translation-back translation and semantic evaluation. The former revealed good acceptance of the translated version of the instrument, which participants considered having items of easy understanding. After completing the process of validation in the country, the instrument will become available to Brazilian researchers to measure health-related quality of life, as well as to compare results from Brazil to that of other cultures in which the instrument has already been validated.