Cost-Effectiveness Analysis to Inform Randomized Controlled Trial Design in Chronic Pain Research: Methods for Guiding Decisions on the Addition of a Run-In Period.

Introduction: Run-In (RI) periods can be used to improve the validity of randomized controlled trials (RCTs), but their utility in Chronic Pain (CP) RCTs is debated. Cost-effectiveness analysis (CEA) methods are commonly used in evaluating the results of RCTs, but they are seldom used for designing RCTs. We present a step-by-step overview to objectively design RCTs via CEA methods and specifically determine the cost effectiveness of a RI period in a CP RCT. Methods: We applied the CEA methodology to data obtained from several noninvasive brain stimulation CP RCTs, specifically focusing on (1) defining the CEA research question, (2) identifying RCT phases and cost ingredients, (3) discounting, (4) modeling the stochastic nature of the RCT, and (5) performing sensitivity analyses. We assessed the average cost-effectiveness ratios and incremental cost effectiveness ratios of varied RCT designs and the impact on cost-effectiveness by the inclusion of a RI period vs. No-Run-In (NRI) period. Results: We demonstrated the potential impact of varying the number of institutions, number of patients that could be accommodated per institution, cost and effectiveness discounts, RCT component costs, and patient adherence characteristics on varied RI and NRI RCT designs. In the specific CP RCT designs that we analyzed, we demonstrated that lower patient adherence, lower baseline assessment costs, and higher treatment costs all necessitated the inclusion of an RI period to be cost-effective compared to NRI RCT designs. Conclusions: Clinical trialists can optimize CP RCT study designs and make informed decisions regarding RI period inclusion/exclusion via CEA methods.

Developing a sampling method and preliminary taxonomy for classifying COVID-19 public health guidance for healthcare organizations and the general public.

BACKGROUND: Development and dissemination of public health (PH) guidance to healthcare organizations and the general public (e.g., businesses, schools, individuals) during emergencies like the COVID-19 pandemic is vital for policy, clinical, and public decision-making. Yet, the rapidly evolving nature of these events poses significant challenges for guidance development and dissemination strategies predicated on well-understood concepts and clearly defined access and distribution pathways. Taxonomies are an important but underutilized tool for guidance authoring, dissemination and updating in such dynamic scenarios. OBJECTIVE: To design a rapid, semi-automated method for sampling and developing a PH guidance taxonomy using widely available Web crawling tools and streamlined manual content analysis. METHODS: Iterative samples of guidance documents were taken from four state PH agency websites, the US Center for Disease Control and Prevention, and the World Health Organization. Documents were used to derive and refine a preliminary taxonomy of COVID-19 PH guidance via content analysis. RESULTS: Eight iterations of guidance document sampling and taxonomy revisions were performed, with a final corpus of 226 documents. The preliminary taxonomy contains 110 branches distributed between three major domains: stakeholders (24 branches), settings (25 branches) and topics (61 branches). Thematic saturation measures indicated rapid saturation (≤5% change) for the domains of "stakeholders" and "settings", and "topic"-related branches for clinical decision-making. Branches related to business reopening and economic consequences remained dynamic throughout sampling iterations. CONCLUSION: The PH guidance taxonomy can support public health agencies by aligning guidance development with curation and indexing strategies; supporting targeted dissemination; increasing the speed of updates; and enhancing public-facing guidance repositories and information retrieval tools. Taxonomies are essential to support knowledge management activities during rapidly evolving scenarios such as disease outbreaks and natural disasters.

Microencapsulation of sacha inchi oil using emulsion-based delivery systems.

In this study, sacha inchi oil (SIO) was microencapsulated by emulsion-based systems using ovalbumin (Ova), pectin (Pec), and xanthan gum (XG), followed by freeze-drying. The microencapsulation was confirmed using Fourier transform infrared (FTIR) spectroscopy, X-ray diffraction (XRD), thermogravimetric analysis (TGA), and scanning electron microscopy (SEM). The stability of omega-3 in SIO alone as well as in microencapsulated SIO was assessed by nuclear magnetic resonance (1H NMR) spectroscopy after human gastric simulation (HGS). The SEM results revealed distinct structures for the two types of microcapsules. The thermograms showed that the thermal resistance was increased in the microencapsulated SIO, indicating that the emulsion-based system may be a way to protect the omega-3 in the SIO. In addition, the microencapsulation conferred an increased crystallinity degree, indicating a higher structural organization. Moreover, this method did not affect the stability of SIO, as confirmed by 1H NMR. The release of omega-3 acyl units from the SIO was correlated with the decrease of the methynic proton (sn, 2 position) of triacylglycerol (TAG). In contrast, the increase of 1,3-diglycerides was negatively correlated with the decrease of glyceryl groups (sn, 1,3 positions). The HGS conditions did not significantly alter the stability of the omega-3 of SIO over 180min. The SIO-Ova microcapsules had a similar behavior to the SIO, and the presence of Ova was not enough to prevent the decrease of omega-3 content over 180min. The SIO-Ova-Pec and SIO-Ova-XG microcapsules were shown to protect the omega-3 content effectively. In conclusion, the microcapsules developed in this study can be used to transport nutraceutical compounds because they are resistant to the human gastric conditions tested in vitro.

No correlation was observed between vitamin D levels and disability of patients with multiple sclerosis between latitudes 18° and 30° South.

Objective: Vitamin D has taken center stage in research and treatment of multiple sclerosis (MS). The objective of the present study was to assess the serum vitamin D levels of a large population of patients with MS and controls living in a restricted tropical area. Methods: Data from 535 patients with MS and 350 control subjects were obtained from 14 cities around the Tropic of Capricorn. Results: The mean serum 25-OH vitamin D level was 26.07 ± 10.27 ng/mL for the control subjects, and 28.03 ± 12.19 ng/mL for patients with MS. No correlation was observed between vitamin D levels and the disability of patients over the disease duration. Conclusion: At least for the region around the Tropic of Capricorn, serum levels of vitamin D typically are within the range of 20 to 30 ng/mL for controls and patients with MS.

No correlation was observed between vitamin D levels and disability of patients with multiple sclerosis between latitudes 18° and 30° South / Não foi observada correlação entre os níveis séricos de vitamina D e a incapacidade em pacientes com esclerose múltipla entre as latitudes Sul 18° e 30°

ABSTRACT Objective: Vitamin D has taken center stage in research and treatment of multiple sclerosis (MS). The objective of the present study was to assess the serum vitamin D levels of a large population of patients with MS and controls living in a restricted tropical area. Methods: Data from 535 patients with MS and 350 control subjects were obtained from 14 cities around the Tropic of Capricorn. Results: The mean serum 25-OH vitamin D level was 26.07 ± 10.27 ng/mL for the control subjects, and 28.03 ± 12.19 ng/mL for patients with MS. No correlation was observed between vitamin D levels and the disability of patients over the disease duration. Conclusion: At least for the region around the Tropic of Capricorn, serum levels of vitamin D typically are within the range of 20 to 30 ng/mL for controls and patients with MS.

RESUMO Objetivo: Vitamina D assumiu um papel central na pesquisa e tratamento da esclerose múltipla (EM). O objetivo deste estudo foi avaliar os níveis séricos de vitamina D de pacientes com EM e controles que residem em uma área tropical. Métodos: Foram analisados dados de 535 pacientes com EM e 350 indivíduos controle em 14 cidades próximas ao Trópico de Capricórnio. Resultados: O valor médio da determinação de 25-OH vitamina D foi 26,07 ± 10,27 ng/mL para controles e 28,03 ± 12,19 ng/mL para pacientes com EM. Não houve correlação entre os níveis de vitamina D e o grau de incapacidade ao longo da duração da doença. Conclusão: Pelo menos na região que cerca o Trópico de Capricórnio, os níveis séricos de vitamina D estão entre valores de 20 a 30 ng/mL tanto para controles quanto para pacientes com EM.

O efeito do tratamento periodontal na proteína c-reativa em pacientes com indicação de cirurgia de revascularização: resultados preliminares / The effect of periodontal treatment in c-reactive protein in patients with indications of surgery revascularization: preliminary results

O objetivo do presente estudo foi examinar o efeito do tratamento periodontal não-cirúrgico sobre a proteína C-reativa, em pacientes com indicação de cirurgia de revascularização no Instituto Nacional de Cardiologia. Foram avaliados 22 pacientes portadores de periodontite crônica, com idade acima de 35 anos (média de idade 59,45 anos) separados em 2 grupos. O grupo I, estudo, (n = 11) recebeu tratamento periodontal anterior ao procedimento cirúrgico, e o grupo II, controle, (n = 11) não realizou tratamento periodontal. Os parâmetros periodontais avaliados foram: profundidade de bolsa à sondagem e nível de inserção clínica. Foram coletadas amostras de sangue de todos os pacientes para análise da proteína C-reativa. Os parâmetros foram avaliados no dia 0, ao início do tratamento periodontal e repetida aos 90 dias, junto com a coleta sanguínea. O tratamento periodontal não-cirúrgico foi eficaz no controle da doença periodontal e aumentou os níveis séricos de proteína C-reativa.

The aim of this study was to examine the effect of periodontal treatment on nonsurgical blood components like C-reactive protein in patients referred for bypass surgery at the Instituto Nacional de Cardiologia. We evaluate 22 patients with chronic periodontitis, aged above 35 years (mean age 59.45 years) divided into 2 groups. The group I, study (n=11), received periodontal treatment prior to cardiovascular surgvyery, and group II, control (n=11) did not have periodontal treatment. The periodontal parameters evaluated were: probing depths and clinical attachment level. Blood samples were collected from all patients for analysis of C-reactive protein. The parameters were evaluated at baseline, in the beginning of periodontal treatment and were repeated after 90 days, along with blood collection. The non-surgical periodontal treatment was effective in controlling periodontal disease and increased serum levels of C-reactive protein.

Processo de trabalho e desgaste operário: um estudo de caso / Work process and worker wearing: one case study

A pesquisa consiste na investigaçäo das formas mais imediatas de desgaste operário os acidentes de trabalho numa planta petroquímica do Pólo de Camaçari-Bahia. Analisamos o nexo entre trabalho e saúde, observando o desgaste que a moderna indústria imprime ao trabalhador, atentando para as especificidades do Pólo. Inicialmente fazemos uma revisäo da literatura sobre processo de trabalho e desgaste operário. Em seguida situamos a empresa e analisamos a sua política de gestäo, particularmente a sua gestäo do desgaste. Em contrapartida, abordamos os discursos que sobre ela desenvolvem os trabalhadores. Por fim, fazemos um mapeamento dos riscos nas unidades para depois desenvolvermos um estudo da trajetória dos acidentes de trabalho na empresa.