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1.
BMJ Open ; 9(10): e028019, 2019 Oct 17.
Artigo em Inglês | MEDLINE | ID: mdl-31628122

RESUMO

OBJECTIVE: We aimed to develop and validate a new instrument called Questionnaire for the assessment of the knowledge, management and reporting ADR in Paediatrics by Healthcare teams (QUESA-P). DESIGN: This is a cross-sectional study. SETTINGS AND PARTICIPANTS: Teams of healthcare professionals (HCP) that lead with pharmacological therapy in Paediatrician's sector (Paediatric-HCP) in seven public hospitals in Brazil. OUTCOME: An assessment of the knowledge and current management of ADR in Paediatric-HCP. METHODS: We developed and validated QUESA-P, using a standardised procedure which included item development and psychometric prevalidation using Cronbach's Alpha, item-total correlation and test-retest validity for internal consistency and reliability. External criterion was used as criterion validation (the instrument was applied to the focus group expert vs focus group team of Paediatric-HCP in hospitals). The focus group of experts who participated in psychometrics was asked to respond to the QUESA-P twice in order to assess test-retest reliability. The content validity of the initial questionnaire was assessed by the Delphi method and pilot test. Subsequently, we made minor revisions and finalized the QUESA-P RESULTS: Selection of domains and facets were based on literature review made in duplicate by authors. Content validity was done by trial of different examiners (panellists, n=16), conducting analysis through Delphi method (three rounds). The QUESA-P was constructed with three domains. The intraclass correlations (0.80) and the Cronbach's alpha coefficient (0.82), indicated adequate test-retest reliability and internal consistency for each domain. The application of the QUESA to 61 Paediatric-HCP in hospital resulted in lower mean score of 42.1 ± 3.4 in all domains when compared with expert teams (n= 46) 48.2 ± 3.7 (p <0.001) indicating that the instrument is valid to discriminate QUESA experts and Paediatric-HCP. CONCLUSION: The selected domains can be used to check weaknesses in the identification, management and reporting of suspected ADR by Paediatric-HCP in Brazil.

2.
Value Health Reg Issues ; 17: 158-163, 2018 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-30316147

RESUMO

OBJECTIVES: To evaluate the effectiveness of an algorithm for the treatment of mixed episodes in bipolar disorder (BD) using the medications available under the Unified Health System (Sistema Único de Saúde) in Brazil. METHODS: The study included 107 individuals with BD in a current mixed episode, assessed biweekly for the outcomes of response and remission. The subjects were randomly assigned to start treatment with lithium, valproic acid, or carbamazepine, following a clinical protocol at a public outpatient clinic. Eligibility screening instruments, semistructured interview, and clinical psychiatric evaluation were used for diagnosis. To measure response and remission, the Hamilton Rating Scale for Depression and the Young Mania Rating Scale were used. A parameter of 50% or less in the symptom scales was used to define responses, as assessed by Kaplan-Meier time-event analysis. RESULTS: For the main outcome, response to treatment, all interventions proposed were proven to be effective, with no difference in response time for any of them. There was a lack of placebo control and blinding for intervention or outcomes. Individuals with mixed episodes in BD often face contradictory symptoms, and these inherent difficulties are the main obstacles to stabilize such a condition. CONCLUSIONS: The findings presented in this study show that the treatments available under the Unified Health System are able to reduce the overall burden of disease in terms of symptom reduction.

3.
Rev. bras. psiquiatr ; 40(1): 26-34, Jan.-Mar. 2018. tab, graf
Artigo em Inglês | LILACS-Express | ID: biblio-899409

RESUMO

Objective: To assess the effectiveness of three mood disorder treatment algorithms in a sample of patients seeking care in the Brazilian public healthcare system. Methods: A randomized pragmatic trial was conducted with an algorithm developed for treating episodes of major depressive disorder (MDD), bipolar depressive episodes and mixed episodes of bipolar disorder (BD). Results: The sample consisted of 259 subjects diagnosed with BD or MDD (DSM-IV-TR). After the onset of symptoms, the first treatment occurred ∼6 years and the use of mood stabilizers began ∼12 years. All proposed algorithms were effective, with response rates around 80%. The majority of the subjects took 20 weeks to obtain a therapeutic response. Conclusions: The algorithms were effective with the medications available through the Brazilian Unified Health System. Because therapeutic response was achieved in most subjects by 20 weeks, a follow-up period longer than 12 weeks may be required to confirm adequate response to treatment. Remission of symptoms is still the main desired outcome. Subjects who achieved remission recovered more rapidly and remained more stable over time. Clinical trial registration: NCT02901249, NCT02870283, NCT02918097

4.
Braz J Psychiatr ; 40(1): 26-34, 2018 Jan-Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28832750

RESUMO

OBJECTIVE: To assess the effectiveness of three mood disorder treatment algorithms in a sample of patients seeking care in the Brazilian public healthcare system. METHODS: A randomized pragmatic trial was conducted with an algorithm developed for treating episodes of major depressive disorder (MDD), bipolar depressive episodes and mixed episodes of bipolar disorder (BD). RESULTS: The sample consisted of 259 subjects diagnosed with BD or MDD (DSM-IV-TR). After the onset of symptoms, the first treatment occurred ∼6 years and the use of mood stabilizers began ∼12 years. All proposed algorithms were effective, with response rates around 80%. The majority of the subjects took 20 weeks to obtain a therapeutic response. CONCLUSIONS: The algorithms were effective with the medications available through the Brazilian Unified Health System. Because therapeutic response was achieved in most subjects by 20 weeks, a follow-up period longer than 12 weeks may be required to confirm adequate response to treatment. Remission of symptoms is still the main desired outcome. Subjects who achieved remission recovered more rapidly and remained more stable over time. CLINICAL TRIAL REGISTRATION: NCT02901249, NCT02870283, NCT02918097.


Assuntos
Antipsicóticos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Transtorno Depressivo Maior/tratamento farmacológico , Transtornos do Humor/tratamento farmacológico , Adulto , Algoritmos , Brasil , Feminino , Humanos , Masculino , Programas Nacionais de Saúde , Fatores Socioeconômicos , Inquéritos e Questionários , Resultado do Tratamento
5.
Rev. bras. psiquiatr ; 38(1): 30-38, Jan.-Mar. 2016. tab, graf
Artigo em Inglês | LILACS-Express | ID: lil-776499

RESUMO

Objective: To perform a cost-utility analysis on the treatment of attention deficit hyperactivity disorder (ADHD) with methylphenidate immediate-release (MPH-IR) in children and adolescents from Brazil. Method: A Markov model was constructed to compare MPH-IR vs. no treatment. A 24-week naturalistic study was conducted to collect transition probabilities and utility data. Effectiveness was expressed as quality-adjusted life-years (QALY), and costs reported in 2014 international dollars (I$). The perspective was the Brazilian Unified Health System as payer, and the time horizon was 6 years. Results: Of 171 patients, 73 provided information at baseline, and 56 at week 24. Considering the MPH-IR monthly cost of I$ 38, the incremental cost-effectiveness ratio (ICER) of treatment was I$ 9,103/QALY for children and I$ 11,883/QALY for adolescents. In two-way sensitivity analysis, considering one Gross National Product per capita (I$ 11,530) as willingness-to-pay, a cost of no-treatment lower than I$ 45/month would render MPH-IR a cost-saving strategy. Discussion: MPH-IR treatment of children and adolescents is cost-effective for ADHD patients from the Brazilian public health system perspective. Both patients and the healthcare system might benefit from such a strategy. Trial registration number: NCT01705613.

6.
Braz J Psychiatr ; 38(1): 30-8, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26375808

RESUMO

OBJECTIVE: To perform a cost-utility analysis on the treatment of attention deficit hyperactivity disorder (ADHD) with methylphenidate immediate-release (MPH-IR) in children and adolescents from Brazil. METHOD: A Markov model was constructed to compare MPH-IR vs. no treatment. A 24-week naturalistic study was conducted to collect transition probabilities and utility data. Effectiveness was expressed as quality-adjusted life-years (QALY), and costs reported in 2014 international dollars (I$). The perspective was the Brazilian Unified Health System as payer, and the time horizon was 6 years. RESULTS: Of 171 patients, 73 provided information at baseline, and 56 at week 24. Considering the MPH-IR monthly cost of I$ 38, the incremental cost-effectiveness ratio (ICER) of treatment was I$ 9,103/QALY for children and I$ 11,883/QALY for adolescents. In two-way sensitivity analysis, considering one Gross National Product per capita (I$ 11,530) as willingness-to-pay, a cost of no-treatment lower than I$ 45/month would render MPH-IR a cost-saving strategy. DISCUSSION: MPH-IR treatment of children and adolescents is cost-effective for ADHD patients from the Brazilian public health system perspective. Both patients and the healthcare system might benefit from such a strategy. TRIAL REGISTRATION NUMBER: NCT01705613.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Análise Custo-Benefício , Metilfenidato/uso terapêutico , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/economia , Brasil , Estimulantes do Sistema Nervoso Central/economia , Criança , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/economia , Custos de Medicamentos/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Masculino , Cadeias de Markov , Metilfenidato/economia , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade
7.
Med Decis Making ; 36(2): 253-63, 2016 02.
Artigo em Inglês | MEDLINE | ID: mdl-26492896

RESUMO

BACKGROUND: Most EQ-5D-3L valuation studies include the same sample of health states that was used in the protocol of the original UK Measurement and Valuation of Health (MVH) study. Thus far, no studies using a time tradeoff utility elicitation method have been carried out using all 243 EQ-5D health states. Because the values and preferences regarding health outcomes differ among countries, it is essential to have country-specific data to enable local high-level decisions regarding resource allocation. This study developed a country-specific set of values for EQ-5D-3L health states. METHODS: A multicentric study was conducted in 4 Brazilian areas. A probabilistic sample of the general population, aged 18 to 64 y, stratified by age and gender, was surveyed. The interview followed a revised version of the MVH protocol, in which all 243 health states were valued. Each respondent ranked and valued 7 health states using the TTO in a home interview. RESULTS: Data were collected from 9148 subjects. The best-fitting regression model was an individual-level mixed-effects model without any interaction terms. The dimensions "Mobility" and "Usual Activities" were associated with higher losses in health state utility value. The "Anxiety/Depression" dimension was the domain that contributed to lower losses in health state utility value. CONCLUSIONS: This study generated significant insight into the Brazilian population's health preferences that can be applied to health technology assessment and economic analyses in Brazil. This information represents an important new tool that can be used in Brazilian health policy creation and evaluation.


Assuntos
Nível de Saúde , Qualidade de Vida , Inquéritos e Questionários/normas , Atividades Cotidianas , Adolescente , Adulto , Fatores Etários , Brasil/epidemiologia , Feminino , Humanos , Masculino , Saúde Mental , Pessoa de Meia-Idade , Limitação da Mobilidade , Dor/epidemiologia , Fatores Sexuais , Fatores Socioeconômicos , Fatores de Tempo , Adulto Jovem
8.
Coron Artery Dis ; 25(3): 215-23, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24553094

RESUMO

BACKGROUND: Long-term nitrate treatment of stable angina is associated with side effects that can interfere with health-related quality of life (HRQoL) and medication adherence. The aim of the present study was to compare HRQoL and adherence to treatment in patients with stable angina undergoing nitrate withdrawal or maintenance. METHODS: This study is a randomized clinical trial. Patients were allocated to an intervention group (nitrate withdrawal followed by introduction of placebo) or a control group (nitrate maintenance). The assessments were made at baseline and 30 and 120 days using the Short Form Health Survey and the Seattle Angina Questionnaire. Treatment adherence was measured on the basis of the Morisky scale and pill count. RESULTS: A total of 105 patients with stable angina were randomized for replacement of nitrate with placebo (n=51) and for maintenance of treatment with nitrate (n=54). After 4 months, Short Form Health Survey scores increased for bodily pain (P=0.005) and general health (P=0.004) in the nitrate maintenance group. Decreased Seattle Angina Questionnaire scores were also noted for physical limitations (P=0.039) and angina frequency (P=0.011) in the nitrate maintenance group. However, the effect size was small (≤0.44) when the intervention and control groups were compared. At the end of the study, adherence was significantly higher in the placebo group (P=0.041), but no difference was detected between the groups with the pill count method. CONCLUSION: HRQoL was similar in patients with stable angina using nitrate regularly as compared with patients undergoing nitrate withdrawal. However, adherence to treatment was lower in nitrate users according to the Morisky scale.


Assuntos
Angina Estável , Fármacos Cardiovasculares/efeitos adversos , Isquemia Miocárdica , Nitratos/efeitos adversos , Dor , Síndrome de Abstinência a Substâncias , Idoso , Angina Estável/tratamento farmacológico , Angina Estável/psicologia , Fármacos Cardiovasculares/farmacologia , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Isquemia Miocárdica/induzido quimicamente , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/psicologia , Nitratos/farmacologia , Dor/induzido quimicamente , Dor/diagnóstico , Dor/psicologia , Qualidade de Vida , Síndrome de Abstinência a Substâncias/diagnóstico , Síndrome de Abstinência a Substâncias/psicologia , Inquéritos e Questionários , Tempo , Resultado do Tratamento
9.
Value Health ; 14(5 Suppl 1): S108-14, 2011 Jul-Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21839880

RESUMO

OBJECTIVES: SF-6D is a preference-based measure of health developed to estimate utility values from the SF-36. The aim of this study was to estimate a weighting system for the SF-6D health states representing the preferences of a sample of the Southern Brazilian general population. METHODS: A sample of 248 health states defined by the SF-6D was valued by a sample of the southern Brazilian population using the standard gamble. Mean and individual level multivariate regression models were fitted to the standard gamble valuation data to estimate preference weights for all SF-6D health states. The models were compared with those estimated in the UK study. RESULTS: Five hundred twenty-eight participants were interviewed, but 58 (11%) were excluded for failing to value the worst state. Data from 469 subjects producing 2696 health states valuations were used in the regression analysis. In contrast to the best performing model for the UK data, the best performing model for the Brazilian data was a random effects model using only the main effects variables, highlighting the importance of adopting a country-specific algorithm to derive SF-6D health states values. Inconsistent coefficients were merged to produce the final recommended model, which has all significant coefficients and a mean absolute difference between observed and predicted standard gamble values of 0.07. CONCLUSIONS: The results provide the first population-based value set for Brazil for SF-6D health states, making it possible to generate quality-adjusted life years for cost-utility studies using regional data. Besides, utility weights derived using the preferences of a sample from a southern Brazilian population can be derived from existing SF-36 data sets.


Assuntos
Indicadores Básicos de Saúde , Anos de Vida Ajustados por Qualidade de Vida , Inquéritos e Questionários , Adulto , Algoritmos , Brasil/epidemiologia , Comparação Transcultural , Características Culturais , Feminino , Humanos , Análise dos Mínimos Quadrados , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Fatores Socioeconômicos , Reino Unido/epidemiologia
10.
Qual Life Res ; 20(7): 1123-9, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21279448

RESUMO

PURPOSE: Normative data for WHOQOL-bref are scarce in the literature and unavailable in Latin American countries. The main objective of this study was to provide normative scores of WHOQOL-bref in a general population sample in Brazil and to describe differences in mean scores according to some socio-demographic characteristics. METHODS: WHOQOL-bref was applied to a randomly selected sample of the general population of Porto Alegre. Participants were literate people aged 20 to 64 years. The questionnaires were self-administered in the presence of an interviewer in the respondent's home. RESULTS: The response rate was 68%, and the final sample contained 751 respondents (38% men, 62% women). Low quality of life was observed in the following subgroups: female gender, lower economic class, lower educational level, and the subgroup reporting a chronic medical condition. The mean scores of the WHOQOL-bref and percentiles of scores are reported as normative data for the general population. CONCLUSION: Our results can be useful to researchers using the WHOQOL-bref to compare their results with normative data from a randomly selected sample of general population. Additionally, the ability of WHOQOL-bref to discriminate different population subgroups makes it an important tool to identify vulnerable groups in epidemiological surveys.


Assuntos
Qualidade de Vida , Inquéritos e Questionários/normas , Adulto , Brasil , Feminino , Indicadores Básicos de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância da População , Psicometria , Adulto Jovem
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