Abstract: Dengue is an important arthropod-borne viral disease in terms of morbidity, mortality, economic impact and challenges in vector control. Benchmarks are expensive, time consuming and require trained personnel. Preventing dengue complications with rapid diagnosis has been based on the testing of easy-to-perform optimized immunochromatographic methods (ICT). This is a systematic meta-analysis review of the diagnostic accuracy of IgA, NS1, IgM and/or IgG ICT studies in suspected cases of acute or convalescent dengue, using a combination of RT-PCR, ELISA NS1, IgM IgG or viral isolation as a reference standard. This protocol was registered in PROSPERO (CRD42014009885). Two pairs of reviewers searched the PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS and EMBASE databases, selected, extracted, and quality-assessed by QUADAS 2. Of 3,783 studies, we selected 57, of which 40 in meta-analyses according to the analyte tested, with high heterogeneity (I2 > 90%), as expected for diagnostic tests. We detected higher pooled sensitivity in acute phase IgA (92.8%) with excellent (90%) specificity. ICT meta-analysis with NS1/IgM/IgG showed 91% sensitivity and 96% specificity. Poorer screening performance was for IgM/IgG ICT (sensitivity = 56%). Thus, the studies with NS1/IgM/IgG ICT showed the best combined performance in the acute phase of the disease.

BackgroundRapid immunochromatographic tests (ICT) for dengue non-structural protein 1 (NS1) have shown good performance for diagnosing acute-phase dengue in serum in laboratory settings, but rarely have been assessed in whole blood and at point of care (POC). This study compare the accuracy and inter- and intra-observer reliability of the NS1 Bioeasy™ ICT in whole blood at POC versus serum in the laboratory, during a DENV-1 epidemic.MethodsCross-sectional study involving 144 adults spontaneously demanding care in an emergency department within 4 days of onset of acute febrile illness. Accuracy of NS1 Bioeasy™ ICT was compared in whole blood and serum, both at 15 and 30 min, blinded to the reference RT-PCR or NS1 ELISA. Non-dengue patients were also tested for Zika virus with RT-PCR. Reliability of whole blood and serum readings by the same or different observers was measured by simple kappa (95% CI).ResultsAt 15 min, sensitivity (Sn) of NS1 Bioeasy™ ICT in whole blood/POC was 76.7% (95% CI: 68.0–84.1) and specificity (Sp) was 87.0% (95% CI: 66.4–97.2). Sn in serum/laboratory was 82% (95% CI: 74.1–88.6) and Sp 100% (95% CI: 85.8–100). Positive likelihood ratio was 5.9 (95% CI: 2.0–17.0) for whole blood/POC and 19.8 (95% CI: 2.9–135.1) for serum/laboratory. Reliability of matched readings of whole blood/POC and serum/laboratory by the same observer (k = 0.83, 95% CI: 0.74–0.93) or different observers (k = 0.81, 95% CI: 0.72–0.92) was almost perfect, with higher discordant levels in the absence of dengue. Results did not differ statistically at 5%.ConclusionsNS1 Bioeasy™ ICT in DENV-1 epidemics is a potentially confirmatory test. Invalid results at 15 min should be reread at 30 min. To optimize impact of implementing ICT in the management of false-negatives it should be incorporated into an algorithm according to setting and available specimen.Trial registration UTN U1111-1145-9451.

Objective: To describe the healthcare resource utilization (HCRU) related to patients with spinal muscular atrophy (SMA) treated at the Brazilian Unified Health System (SUS) since 2015 according to age-groups. Methods: This study analyzed outpatient and inpatient data for SMA patients from the Brazilian Unified Health System database (DATASUS) from January 2015 to September 2020. Data were collected from patients with ICD-10 codes G12.0 (Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]) or G12.1 (Other inherited spinal muscular atrophy), plus with at least one claim of nusinersen OR at least one claim of any SMA-related procedure groups codes since 2010. SMA-related procedures were defined based on collaborative work involving authors from medical boarding composed by physicians from SUS. Results: In total, 3,775 patients with SMA fulfilled the eligibility criteria. Physiotherapy changed from 11.34 (2.49 – 24.40) procedures PPPY in the 0 - 6-month old group to 3.30 (0.84 – 11.76) procedures PPPY in the > 36-month old group. The median of orthosis was 1.64 (0.66 – 3.41) procedures PPPY in the 0 – 6-month old group and 0.63 (0.34 – 1.33) PPPY in the > 36-month-old group. Exams were primarily performed for younger groups (0 – 6 months and > 6 – 18 months). The percentage of patients that needed some ventilatory care seems greater, and the speech therapy and the use of nusinersen seem lower along with age. Conclusion: This study has demonstrated important HCRU at the SUS setting with SMA patients. In addition, our results highlight the need to implement evidence-based strategies to manage SMA patients and drive cost savings for the health care system

OBJECTIVE: To describe the four types of horizon scanning (HS) outputs developed by the National Committee for Health Technology Incorporation (CONITEC) and show their main repercussions on the decision-making processes of the Brazilian Ministry of Health (MH). METHODS: Descriptive study based on participant observation and document analysis of HS outputs (internal reports, alert reports, briefs and sections for CONITEC recommendation reports) developed between January 2014 and July 2018. RESULTS: Fifteen internal reports, six alert reports, two briefs and 57 HS sections were produced. Each output has a specific structure according to its purpose. The methodological approach adopted for developing HS outputs in Brazil is described by EuroScan International Network. The outputs had institutional and international repercussions. The activities resulted in the inclusion of HS as a tool for reducing health lawsuits in the legal framework of the MH. One of the internal reports on a high-cost drug not approved in Brazil for a rare disease was requested by the Health Technology Assessments Network for the Americas (RedETSA), showing the international relevance of the outputs. The HS sections in recommendation reports influenced discussions about incorporating technologies into the Unified Health System. CONCLUSIONS: The developed outputs have purposes ranging from helping build arguments for defense of the MH in cases of health judicialization to inform decision-making processes. In addition, HS sections in recommendation reports have grown in importance recently. CONITEC’s HS system has been structured, and its role as a tool to inform health managers has shown to be been relevant.

No abstract