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Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Competências profissionais do enfermeiro: Revisão Integrativa de literatura

Objetivo: identificar, nas produções científicas, os fatores relacionados à construção da identidade
profissional do enfermeiro. Métodos: Trata-se de revisão integrativa realizada nas bases de dados
SCIELO, BDENF e LILACS disponíveis na Biblioteca virtual em saúde no intervalo temporal de
2015 a 2019 a partir dos descritores “Papel do profissional de enfermagem” AND “Cuidados de
enfermagem” OR “Competência profissional”. Resultados: A identificação profissional do
enfermeiro está relacionada à sua atuação no serviço de saúde com estratégias de atendimento
domiciliar, empreendedorismo, gerenciamento do cuidado e da equipe, educação em saúde,
consultas de enfermagem, procedimentos técnicos, articulação da rede de atenção, organização do
serviço e qualificação da equipe mas que sofrem algumas limitações individuais, organizacionais,
institucionais e sociais. Conclusão: A identificação dos fatores que caracterizam o enfermeiro e
fomentam sua identidade profissional exerce grande influência no empoderamento da categoria e
melhor autonomia nos diversos campos de atuação.
Descritores: Papel do profissional de enfermagem; Cuidados de enfermagem; Competência
profissional.

Empirical Testing of a Middle‐Range Theory for Ineffective Breathing Pattern in Children With Congenital Heart Disease

ABSTRACT

Aim

To test a middle-range theory (MRT) for the nursing diagnosis of ineffective breathing pattern in children with congenital heart disease (CHD) based on analysis of two general propositions.

Methods

This cross-sectional study is guided by STROBE. The propositions represent hypotheses about the relationships between the concepts of this MRT to be tested empirically, and thus, log-linear models were used to verify the structure of the proposition related to the stimuli. Diagnostic accuracy measures, univariate logistic regressions and the Mann–Whitney test were used to analyse the structure of the propositions related to behaviours.

Results

The analysis of the propositions related to the stimuli (eight concepts, four of which were classified as focal stimuli and four as contextual stimuli) suggested a reclassification of the stimulus “deformities in the thoracic wall” which became too focal. In the analysis of the propositions related to behaviours (17 concepts, five of which were classified as acute confirmatory, nine as acute clinical deterioration and three classified as chronic), guided changes in the operationalisation of concepts were suggested after comparing clinical findings; thus, acute confirmatory behaviours now have 10 concepts, while acute clinical deterioration behaviours and chronic behaviours continued with nine and three concepts, respectively, but with reclassifications between them.

Conclusion

Changes in the operationalisation of the classification of the elements of the two propositions occurred after comparing the clinical findings with the theoretical model.

Relevance to Clinical Practice

By establishing precise causal relationships and describing how IBP manifests itself over time in children with CHD, empirical testing of this MRT helps nurses understand clinical reasoning based on temporal logic and spectral interaction between diagnostic components, which in turn will improve the use and accuracy of nursing diagnoses.

Patient Contribution

Children and adolescents with CHD were recruited for this study sharing their clinical history and physical lung examination.

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