All-cause and cause-specific mortality among people with severe mental illness in Brazil's public health system, 2000-15: a retrospective study.

BACKGROUND: People with severe mental illness have a mortality rate higher than the general population, living an average of 10-20 years less. Most studies of mortality among people with severe mental illness have occurred in high-income countries (HICs). We aimed to estimate all-cause and cause-specific relative risk (RR) and excess mortality rate (EMR) in a nationwide cohort of inpatients with severe mental illness compared with inpatients without severe mental illness in a middle income country, Brazil. METHODS: This national retrospective cohort study included all patients hospitalised through the Brazilian Public Health System (Sistema Único de Saúde [SUS]-Brazil) between Jan 1, 2000, and April 21, 2015. Probabilistic and deterministic record linkages integrated data from the Hospital Information System (Sistema de informações Hospitalares) and the National Mortality System (Sistema de Informação sobre Mortalidade). Follow-up duration was measured from the date of the patients' first hospitalisation until their death, or until April 21, 2015. Severe mental illness was defined as schizophrenia, bipolar disorder, or depressive disorder by ICD-10 codes used for the admission. RR and EMR were calculated with 95% CIs, comparing mortality among patients with severe mental illness with those with other diagnoses for patients aged 15 years and older. We redistributed deaths using the Global Burden of Diseases, Injuries, and Risk Factors Study methodology if ill-defined causes of death were stated as an underlying cause. FINDINGS: From Jan 1, 2000, to April 21, 2015, 72 021 918 patients (31 510 035 [43·8%] recorded as male and 40 974 426 [56·9%] recorded as female; mean age 41·1 (SD 23·8) years) were admitted to hospital, with 749 720 patients (372 458 [49·7%] recorded as male and 378 670 [50·5%] as female) with severe mental illness. 5 102 055 patient deaths (2 862 383 [56·1%] recorded as male and 2 314 781 [45·4%] as female) and 67 485 deaths in patients with severe mental illness (39 099 [57·9%] recorded as male and 28 534 [42·3%] as female) were registered. The RR for all-cause mortality in patients with severe mental illness was 1·27 (95% CI 1·27-1·28) and the EMR was 2·52 (2·44-2·61) compared with non-psychiatric inpatients during the follow-up period. The all-cause RR was higher for females and for younger age groups; however, EMR was higher in those aged 30-59 years. The RR and EMR varied across the leading causes of death, sex, and age groups. We identified injuries (suicide, interpersonal violence, and road injuries) and cardiovascular disease (ischaemic heart disease) as having the highest EMR among those with severe mental illness. Data on ethnicity were not available. INTERPRETATION: In contrast to studies from HICs, inpatients with severe mental illness in Brazil had high RR for idiopathic epilepsy, tuberculosis, HIV, and acute hepatitis, and no significant difference in mortality from cancer compared with inpatients without severe mental illness. These identified causes should be addressed as a priority to maximise mortality prevention among people with severe mental illness, especially in a middle-income country like Brazil that has low investment in mental health. FUNDING: Bill and Melinda Gates Foundation, Fundação de Amparo a Pesquisa do Estado de Minas Gerais, FAPEMIG, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil.

A demographic and clinical panorama of a sixteen-year cohort of soft tissue sarcoma patients in Brazil.

Little is known about soft tissue sarcomas (STS) in Brazil, once the federal statistics regarding estimates on incidence and mortality of the most common cancers that affect the Brazilian population currently do not include STS. This study aims to perform a broad evaluation and description of the epidemiological profile, access to treatment and main clinical outcomes of the Brazilian STS patient. A population-based cohort study of 66,825 patients who underwent procedures related to STS treatment registered in the Brazilian public health system (Sistema Único de Saúde, SUS) databases. Median age was 57 years, 30% of them older than 65 years and 50.7% of the cohort was female. The majority, 50,383 patients (75.4%), was diagnosed between 2008 and 2015. Most prevalent anatomic sites were upper and lower limbs (12.6%) and the registry of sarcomas without a specific location comprehended 29.7% of the cohort. The majority of patients resided in the Northeast (40.2% of the patients). Surgery was the first treatment modality in 77.7% of the cases. For survival analysis, only patients with stage and histological grade information were included. The 1-, 5- and 10-year survival rate of the patients was, respectively, 75.4% (95% CI = 74.1-76.7%), 43.4% (95% CI = 41.5-45.5%) and 18.6% (95% CI = 14.8-23.3%).

Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: A 16-year non-concurrent cohort study.

BACKGROUND: Relapsing-remitting multiple sclerosis (RRMM) is a chronic, progressive, inflammatory and immune-mediated disease that affects the central nervous system and is characterized by episodes of neurological dysfunction followed by a period of remission. The pharmacological strategy aims to delay the progression of the disease and prevent relapse. Interferon beta and glatiramer are commonly used in the Brazilian public health system and are available to patients who meet the guideline criteria. The scenario of multiple treatments available and in development brings the need for discussion and evaluation of the technologies already available before the incorporation of new drugs. This study analyses the effectiveness of first-line treatment of RRMS measured by real-world evidence data, from the Brazilian National Health System (SUS). METHODS AND FINDINGS: We conducted a non-concurrent national cohort between 2000 and 2015. The study population consisted of 22,722 patients with RRMS using one of the following first-line drugs of interest: glatiramer or one of three presentations of interferon beta. Kaplan-Meier analysis was used to estimate the time to treatment failure. A univariate and multivariate Cox proportional hazard model was used to evaluate factors associated with treatment failure. In addition, patients were propensity score-matched (1:1) in six groups of comparative first-line treatments to evaluate the effectiveness among them. The analysis indicated a higher risk of treatment failure in female patients (HR = 1.08; P = 0,01), those with comorbidities at baseline (HR = 1.20; P<0,0001), in patients who developed comorbidities after starting treatment (i.e., rheumatoid arthritis-HR = 1.65; P<0,0001), those exclusive SUS patients (HR = 1.31; P<0,0001) and among patients using intramuscular interferon beta (IM ßINF-1a) (28% to 60% compared to the other three treatments; P<0,0001). Lower risk of treatment failure was found among patients treated with glatiramer. CONCLUSIONS: This retrospective cohort suggests that glatiramer is associated with greater effectiveness compared to the three presentations of interferon beta. When evaluating beta interferons, the results suggest that the intramuscular presentation is not effective in the treatment of multiple sclerosis.

Who should pay for the continuity of post-trial health care treatments?

BACKGROUND: The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that "prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process". However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. METHODS: Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. RESULTS: The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients' rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. CONCLUSION: The countries of Latin America and South Korea, currently, do not have laws that address patients' rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.

Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Diabetes Mellitus (DM) is a chronic disease that is considered a global public health problem. Education and self-monitoring by diabetic patients help to optimize and make possible a satisfactory metabolic control enabling improved management and reduced morbidity and mortality. The global growth in the use of mobile phones makes them a powerful platform to help provide tailored health, delivered conveniently to patients through health apps. OBJECTIVE: The aim of our study was to evaluate the efficacy of mobile apps through a systematic review and meta-analysis to assist DM patients in treatment. METHODS: We conducted searches in the electronic databases MEDLINE (Pubmed), Cochrane Register of Controlled Trials (CENTRAL), and LILACS (Latin American and Caribbean Health Sciences Literature), including manual search in references of publications that included systematic reviews, specialized journals, and gray literature. We considered eligible randomized controlled trials (RCTs) conducted after 2008 with participants of all ages, patients with DM, and users of apps to help manage the disease. The meta-analysis of glycated hemoglobin (HbA1c) was performed in Review Manager software version 5.3. RESULTS: The literature search identified 1236 publications. Of these, 13 studies were included that evaluated 1263 patients. In 6 RCTs, there were a statistical significant reduction (P<.05) of HbA1c at the end of studies in the intervention group. The HbA1c data were evaluated by meta-analysis with the following results (mean difference, MD -0.44; CI: -0.59 to -0.29; P<.001; I²=32%).The evaluation favored the treatment in patients who used apps without significant heterogeneity. CONCLUSIONS: The use of apps by diabetic patients could help improve the control of HbA1c. In addition, the apps seem to strengthen the perception of self-care by contributing better information and health education to patients. Patients also become more self-confident to deal with their diabetes, mainly by reducing their fear of not knowing how to deal with potential hypoglycemic episodes that may occur.

Relacionamento de registros de grandes bases de dados: estimativa de parâmetros e validação dos resultados, aplicados ao relacionamento dos registros das autorizações de procedimentos ambulatoriais de alta complexidade com os registros de sistema de informações hospitalares. / Record linkage of large data sources: parameter estimation and results validation, applied to the linkage of high complexity procedures authorizations with the hospital information system.

O relacionamento probabilístico de registros tem sido utilizado para integrar dados dos Sistemas de Informação do Sistema Único de Saúde (SUS). Contudo, ainda são necessários mais estudos dedicados à estimativa de parâmetros para o relacionamento e a validação de seus resultados. Neste trabalho, foram relacionados os registros de dois grandes sistemas de informações do SUS: o Sistema de Informações Hospitalares (SIH) e as Autorizações de Procedimentos de Alta Complexidade (Apac) do Sistema de Informações Ambulatoriais (SIA-SUS), na modalidade Terapia Renal Substitutiva (TRS). Foram relacionados 39.448.139 registros do SIH com 645.338 da Apac/SIA-SUS. No processo foram utilizadas três técnicas para estimar os parâmetros do relacionamento, dentre elas o algoritmo EM. Para validar os resultados e definir o ponto de corte, construiu-se uma curva precision-recall (PR), utilizando-se, como padrão ouro a revisão manual por dois revisores independentes. A sensibilidade, a especificidade, o valor preditivo positivo e o valor preditivo negativo para o ponto de corte selecionado foram, respectivamente, de 0,957; 0,999; 0,962; 0,999. A concordância entre os dois revisores foi excelente (Kappa=0,956). Ao final, foram identificadas 418.336 internações referentes a 104.109 indivíduos.

Record linkage has been used to integrate data from Information System of Single Health System (SUS, acronym in Portuguese). However, studies dedicated to parameter estimation and validation of the results are still necessary. The present study described the record linkage of two Brazilian health information systems, concerning patients under renal replacement therapy: the hospital information system (SHI ? Sistema de Informações Hospitalares) and the outpatient information system (SIA ? Sistema de Informações Ambulatoriais) of SUS Overall, 39,448,139 records from SIH were linked to 645,338 records from Apac/SIA/SUS. In the process, three techniques were used to estimate the linkage parameters, including the EM algorithm. To validate the results and define the cut-off, a precision-recall curve was plotted, using as gold-standard the manual review by two independent examiners. Sensibility, specificity, positive predictive value and negative predictive value where, respectively, 0.957; 0.999; 0.962; 0.999. The agreement rate between the two reviewers was considered excellent (Kappa=0.956). As a result 418,336 hospitalizations of 104,109 patients were identified.