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Prospective cohort study of TIMP-1 and myocardial fibrosis in Chagas disease at a reference clinic in Pernambuco, Brazil: PTICH trial protocol

Por: Martins · S. M. · Macedo · C. T. · Meira · C. S. · Paim Santos · L. H. · Larocca · T. F. · Cavalcanti da Silva · F. F. · Leandro Lira · C. N. · da Silva · I. P. M. · De Araujo · L. T. · Soares · M. B. P.
Background

Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Methods and analysis

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

Ethics and dissemination

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

Trial registration number

RBR-3dcrj98.

Interfaces between communication, education and health: a scoping review protocol

Introduction

The interfaces between the fields of communication, education and health have been indicated by international institutions such as the WHO and the European Centre for Disease Prevention and Control. However, hegemonic scientific practices supersede dialogue between the three fields, isolating their practices. This fragmenting tendency is observed in scientific literature, which has created gaps in the dialogue and articulation between communication, education and health. Although health promotion requires both communicative and educational practices, the epistemological, historical, political, cultural and socioeconomic aspects have also engendered tensions between the fields. Communication is often seen as a mere instrument for other practices, rather than a phenomenon that (re)produces meanings and power dynamics. In opposing the reductionist and instrumentalising perspectives of knowledge fields, the primary objective of the scoping review is to map the scientific evidence on the interfaces between communication and education in health to indicate a conceptual framework that articulates communication and education practices within the context of health.

Methods and analysis

A transdisciplinary team developed this protocol based on the 2024 Joanna Briggs Institute Manual for Evidence Synthesis. The procedures required to conduct the review were guided by the frameworks proposed by Arksey and O'Malley, Levac et al and Peters et al. The study eligibility criteria were established based on the Problem, Concept and Context outlined in the research questions. Primary and secondary studies will be retrieved from nine sources, covering both conventional and grey literature. These sources include Embase, ERIC, LILACS, PubMed/MEDLINE, ScienceDirect, Scopus, Web of Science, the Brazilian Digital Library of Theses and Dissertations, and the Networked Digital Library of Theses and Dissertations. A categorised form will be used for data collection and subsequent analysis. The reporting of the review findings will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination

The nature of the research and the use of secondary data sources do not require informed consent forms or approval from ethics committees in Brazil. The scientific findings from the review will be disseminated through peer-reviewed journals, academic conferences and other scientific communication channels.

Study registration

The protocol was registered on the Open Science Framework (OSF) and is available at https://doi.org/10.17605/OSF.IO/Z3CX7.

Typologies of common maternal mental disorders and associated factors: a quantitative life course study applied to cohort data in a resource-constrained setting in Northeastern Brazil

Objectives

We aim to identify trajectories of probable maternal common mental disorders (CMD), as well as risk and protective factors associated with maternal mental health among postpartum women during the pandemic using life course theory approach.

Design

Prospective individual level cohort study from the Iracema-COVID Study.

Population

Mothers (n=335) at postpartum period who delivered during the COVID-19 pandemic in the fourth largest city in Brazil.

Methods

Probable CMDs were accessed using validated instruments in five cohort waves at postpartum period. Sequence analyses (SA) were employed to extract CMD trajectories, and a set of generalised binomial logistic and log-Poisson multivariable regression models with robust variance were employed to assess risk and protective factors for probable CMDs diagnosis.

Outcome measures

Trajectories patterns of probable maternal common mental disorders.

Results

Fit indices demonstrated a two-cluster-SA solution of probable CMD. The patterns of probable CMDs indicated that 335 mothers were clustered into occasional/transitory (n=240, 71.64%) and mostly/persistent (n=95, 28.36%) CMD trajectories. We found that mothers with low education (OR: 2.44; 95% CI 1.13 to 5.23), single (OR: 1.97; 95% CI 1.03 to 3.75) or in a stable union (OR: 2.00; 95% CI 1.02 to 3.90) and travel time spent to access the nearest primary healthcare unit (OR: 1.02; 95% CI 1.006 to 1.04) were associated with increased OR of belonging to the mostly/persistent CMD trajectory. Deprived green areas acted as a risk factor to maternal CMDs prevalence (OR: 1.37; 95% CI 1.002 to 1.87).

Conclusions

This study provides evidence that individual vulnerabilities and neighbourhood deprivation play an important role in understanding maternal mental health, beyond the patterns and trajectories of probable maternal CMD due to issues confronted during the COVID-19 outbreak in the northeastern region of Brazil. Policies to prevent and treat maternal mental health issues and improvement in neighbourhood deprivation need to be developed and addressed to avoid exacerbation of probable maternal CMDs.

Real-world effectiveness of perinatal RSV immunoprophylaxis: protocol for a test-negative case-control study

Por: Aparicio Llorente · C. · Wats · A. · Araujo · B. L. · Moniz Ganem · J. · Oliva · I. O. · Xu · H. · Brodsky · N. N. · Lucas · C. L. · Aronson · P. L. · Grubaugh · N. D. · Breban · M. · Redmond · S. · Shapiro · E. D. · Niccolai · L. M. · Weinberger · D. M. · Oliveira · C. R.
Introduction

Respiratory syncytial virus (RSV) is a leading cause of hospitalisation in infants worldwide. New immunoprophylactic products, including long-acting monoclonal antibodies and maternal vaccines, have demonstrated high efficacy in prelicensure clinical trials. Understanding how these interventions perform outside controlled trials, and how viral evolution or host factors influence protection, is essential for sustaining confidence in RSV prevention programmes.

Methods and analysis

We will conduct a 5-year, test-negative case–control study among infants ≤12 months of age who present with acute respiratory illness (ARI) within a large healthcare delivery network serving a demographically diverse population. Cases will be infants testing positive for RSV by PCR, and controls will be RSV-negative infants meeting the same ARI criteria. Data will be obtained from electronic health records, structured caregiver surveys and state immunization registries to ensure accurate classification of exposures and covariates. Vaccine effectiveness will be estimated using multivariable logistic regression controlling for potential confounding. RSV-positive specimens will undergo full-genome sequencing to identify variant lineages and potential immune-escape mutations. A subset of participants will provide acute and convalescent blood samples for single-cell immune profiling to define innate and adaptive responses associated with breakthrough infection.

Ethics and dissemination

The study protocol has been approved by the Yale Human Investigation Committee (HIC #2000036550). Written informed consent will be obtained from all parents or legal guardians prior to participation. Study findings will be disseminated through peer-reviewed publications, scientific meetings and public repositories, with fully de-identified participant data to protect privacy and confidentiality. Viral genomic data will be shared in accordance with the National Institutes of Health Genomic Data Sharing Policy, and analytical code will be made publicly available to ensure reproducibility.

Trial registration number

NCT06172660.

Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol

Por: Mendes · R. G. · Leonardi · N. T. · Castello-Simoes · V. · Kawakami · D. M. d. O. · Souza · J. V. R. · Schafauser-Segundo · N. S. · Simoes · R. P. · Pinto · F. G. · Araujo · G. H. G. · da Silva · M. M. C. · Moriguchi · C. S. · Franco · F. J. B. Z. · Pires Di Lorenzo · V. A. · Jor
Introduction

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

Objective

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

Methods and analysis

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

Ethics and dissemination

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

Trial registration number

NCT07050823/NCT07093021/NCT07134855.

Nursing Interventions to Support Family Caregivers of Patients on Haemodialysis: A Mixed‐Methods Systematic Review

ABSTRACT

Aims

To identify and synthesise nursing interventions directed at family caregivers of patients with end-stage renal disease undergoing haemodialysis.

Design

A convergent-integrated mixed-methods systematic review.

Data Sources

A comprehensive search was conducted in EBSCOHost databases (Academic Search Complete, CINAHL Complete, MEDLINE with Full Text, MedicLatina, ERIC) and the PubMed database. Studies were appraised using the Mixed-Methods Appraisal Tool (MMAT), and interventions were classified using the Cochrane Effective Practice and Organisation of Care taxonomy.

Review Methods

Quantitative data were narratively synthesised and transformed into textual descriptions to enable integration with qualitative findings. A thematic synthesis was conducted to group similar concepts.

Results

Twenty-three studies met the inclusion criteria. Most were quantitative or mixed methods with moderate-to-high methodological quality. Interventions were primarily classified as disease management (n = 10) or self-management support (n = 9). Common components included education, coping strategies, empowerment, and psychosocial support. Positive effects were observed on caregiver quality of life, anxiety, depression, and self-efficacy. Caregiver burden outcomes were mixed, potentially influenced by time and intervention intensity. Additional benefits were noted from relaxation techniques and intradialytic exercise. Qualitative data revealed culturally embedded coping strategies such as spiritual practices, time management and seeking social support.

Conclusion

Educational and empowerment-based nursing interventions—particularly those supporting dyadic coping and family-centred care—can improve caregiver outcomes. Frameworks such as the Roy Adaptation Model and the ‘Timing it Right’ approach enhance intervention design and relevance.

Impact

By addressing caregiver needs through structured education, psychosocial support and contextually sensitive approaches, nurses can mitigate caregiver burden and promote long-term caregiver well-being and patient adherence to treatment.

Patient or Public Contribution

Although patients and caregivers were not directly involved, this review contributes to improving nursing care for family caregivers of individuals with ESRD, aiming to enhance their quality of life.

Authentic Nursing Leadership and Safety Climate Across Hospital Settings During the COVID‐19 Pandemic: A Cross‐Sectional Study

ABSTRACT

Aim

To analyse the relationship between authentic nursing leadership and safety climates across hospital settings during the COVID-19 pandemic.

Background

Authentic nursing leadership shapes the safety climate by fostering positive perceptions of workplace policies, processes, procedures and practices that influence how safety is prioritised and addressed within an organisation.

Design

A cross-sectional study.

Methods

Our study was conducted from December 2021 to December 2022 in six Brazilian hospitals. Participants were nursing staff working in General Medicine Units, Intensive Care Units (ICU) and Emergency Departments (ED) who provided care to patients with COVID-19. The Authentic Leadership Questionnaire and the Safety Attitudes Questionnaire were used to measure nursing staff perceptions of authentic leadership and safety climates. Data were analysed using descriptive and inferential statistics.

Results

391 nursing staff across six hospitals participated. Self-awareness significantly enhanced perceptions of the safety climates. Additionally, being a Registered Nurse and working in the ICU were positively associated with achieving safe climates in the working environment. In contrast, working in EDs was significantly negatively related to safety climates.

Conclusions

The COVID-19 pandemic underscored a lack of authentic nursing leadership and unsafe climates. Therefore, it is critical to implement educational strategies that foster authentic leadership, particularly focusing on self-awareness, to promote more positive safety climates. Ensuring that leadership and safety climates are relationship-focused is critical to enhancing patient outcomes.

Implications for the Profession and/or Patient Care

Nursing staff's perceptions of authentic leadership and safety climates are important in making more informed decisions about patient management.

Impact

Since self-awareness increases positive perceptions of safety climates, nursing staff should exercise it to guide their actions in facing future health crises.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

Higher self-awareness in relationships with others is a predictor of safety climates and can lead to enhanced patient outcomes.

Effects of photobiomodulation therapy combined with static magnetic field on pain and function in patients with lateral epicondylitis: a multicentre, randomised, placebo-controlled trial

Por: de Oliveira · M. F. D. · Leal-Junior · E. C. P. · Machado · C. d. S. M. · Ribeiro · N. F. · Dias · L. B. · Lino · M. M. A. · Araujo-Silva · O. M. · Casalechi · H. L. · Johnson · D. S. · Tomazoni · S. S.
Introduction

Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.

Objectives

The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.

Design

Multicentre, randomised, triple-blinded, placebo-controlled trial.

Setting

Three outpatient physiotherapy clinics in Brazil.

Participants

50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).

Interventions

Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.

Primary and secondary outcome measures

The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.

Results

PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p

Conclusions

PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.

Trial registration number

NCT04829734 on ClinicalTrials.gov

Effects of an early behavioural change strategy following COPD exacerbation in hospital and outpatient settings in Brazil: protocol for a randomised clinical trial on cardiovascular risk, physical activity and functionality

Por: Kawakami · D. M. d. O. · Karloh · M. · Araujo · G. H. G. · Colucci · M. G. · Pires Di Lorenzo · V. A. · Mendes · R. G.
Introduction

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

Methods and analysis

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

Ethics and dissemination

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Trial registration number

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide
Objective

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Design

Observational study.

Participants

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

Primary and secondary outcomes

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

Results

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Conclusion

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

Sustained natural immunity following SARS-CoV-2 infection against severe COVID-19 outcomes and symptomatic reinfection: analyses of national data for Brazil and Scotland

Por: Haider · F. · Cerqueira-Silva · T. · Hainey · K. J. · Millington · T. · Shah · S. A. · de Araujo Oliveira · V. · Pearce · N. · Barreto · M. L. · Boaventura · V. S. · Katikireddi · S. V. · Robertson · C. · Barral-Netto · M. · Sheikh · A.
Objectives

SARS-CoV-2 infection provides protection against reinfection and severe COVID-19 disease; however, this protective effect may diminish over time. We assessed waning of natural immunity conferred by previous infection against severe disease and symptomatic reinfection in Brazil and Scotland.

Design

We undertook a test-negative design study and nested case–control analysis to estimate waning of natural immunity against severe COVID-19 outcomes and symptomatic reinfection using national linked datasets. We used logistic regression to estimate ORs with 95% CIs. A stratified analysis assessed immunity during the Omicron dominant period in Brazil.

Setting and participants

We included data from the adult populations of Brazil and Scotland from 1 June 2020 to 30 April 2022.

Outcome measures

Severe COVID-19 was defined as hospitalisation or death. Reinfection was defined as reverse-transcriptase PCR or rapid antigen test confirmed at least 120 days after primary infection.

Results

From Brazil, we included 30 881 873 tests and 1 301 665 severe COVID-19 outcomes, and from Scotland, we included 1 520 201 tests and 7988 severe COVID-19 outcomes. Against severe outcomes, sustained protection was observed for at least 12 months after primary SARS-CoV-2 infection with little evidence of waning: 12 months postprimary infection: Brazil OR 0.12 (95% CI 0.10 to 0.14), Scotland OR 0.03 (95% CI 0.02 to 0.04). For symptomatic reinfection, Brazilian data demonstrated evidence of waning in the 12 months following primary infection, although some residual protection remained beyond 12 months: 12 months postprimary infection: OR 0.42 (95% CI 0.40 to 0.43). The greatest reduction in risk of SARS-CoV-2 infection was in individuals with hybrid immunity (history of previous infection and vaccination), with sustained protection against severe outcomes at 12 months postprimary infection. During the Omicron dominant period in Brazil, odds of symptomatic reinfection were higher and increased more quickly over time when compared with the overall study period, although protection against severe outcomes was sustained at 12 months postprimary infection (whole study: OR 0.12 (95% CI 0.10 to 0.14); Omicron phase: OR 0.15 (95% CI 0.12 to 0.19)).

Conclusion

Cross-national analyses demonstrate sustained protection against severe COVID-19 disease for at least 12 months following natural SARS-CoV-2 infection, with vaccination further enhancing protection. Protection against symptomatic reinfection was lower with evidence of waning, but there remained a protective effect beyond 12 months from primary infection.

Correlation between fatigue and pulmonary involvement in the post-COVID-19 condition: a cross-sectional study 6-12 months after hospital discharge

Por: Kajiwara · M. S. · Lamas · C. A. · Luna · L. A. V. d. · Yokoyama · T. S. · de Oliveira · P. R. · Chate · R. C. · Sawamura · M. V. Y. · Imamura · M. · Carvalho · C. R. R. d. · Salge · J. M. · HCFMUSP COVID-19 task force · Araujo · Segurado · Montal · Miethke-Morais · Levin · Peron
Introduction

Post-COVID-19 conditions (PCC) may include pulmonary sequelae, fatigue and other symptoms, but its mechanisms are not fully elucidated.

Objective

This study investigated the correlation between fatigue and the presence of pulmonary abnormalities in PCC patients with respiratory involvement 6–12 months after hospitalisation.

Design

Cross-sectional study.

Setting

A tertiary hospital in Brazil.

Participants

315 patients, aged ≥18 years, were considered eligible based on SARS-CoV-2 infection confirmed by reverse transcription-PCR.

Methods

Pulmonary function tests (PFT), cardiopulmonary exercise tests (CPET), chest CT and hand grip were performed. The following scales were applied: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Euroqol 5 Dimensions quality of life (EQ-5D) and Hospital Anxiety and Depression Scale (HADS). Participants were divided between the fatigue group (FACIT-F≤30) and the non-fatigue group (FACIT-F>30). For the statistical analysis, the primary outcome was the difference in the diffusing capacity of the lungs for carbon monoxide (DLCO) between groups. Considered secondary outcomes were differences in PFT, CPET, chest CT, hand grip, EQ-5D and HADS.

Results

The fatigue group had 81 patients (25.7%) against 234 (74.3%). PFT and CPET showed no significant difference in DLCO and oxygen consumption peak values between groups. The fatigue group had a lower workload (mean 55.3±21.3 watts vs 66.5±23.2 watts, p=0.003), higher breathing reserve (median 41.9% (33.8–52.5) vs 37.7% (28.9–47.1), p=0.028) and lower prevalence of ground glass opacity (60.8% vs 77.7%, p=0.003) and reticulation (36.7% vs 54.9%, p=0.005) in chest CT. The fatigue group had higher anxiety (57% vs 24%, p

Conclusion

Fatigue in patients with PCC 6–12 months after hospitalisation is relatively common and had weak correlation with pulmonary disorders. Our results suggested fatigue could be strongly related with peripheral disorders such as reduced musculoskeletal strength or psychosocial limitations.

Home-based self-administered transcranial direct current stimulation for women affected by primary dysmenorrhoea in Northeastern Brazil: a protocol study

Por: Silva · T. C. d. L. A. d. · Rodrigues · Y. T. · Silva-Filho · E. · Alves de Oliveira · P. C. · Araujo · T. A. B. D. · Bernatavicius · E. · Cook · A. A. · Radyte · E. · Pegado · R. · Micussi · M. T.
Background

The prevalence of women with primary dysmenorrhoea is high and negatively impacts physical and mental health. The intense cyclic episodes of pain generate central nervous system dysfunctional processing. In this sense, strategies focused on the central nervous system are important to re-establish normal functioning. Home-based self-administered transcranial direct current stimulation (tDCS) emerges as a strategy to modulate dysfunctional brain areas and improve the symptoms. This protocol aims to evaluate the effects of home-based self-administered tDCS for pain, premenstrual symptoms, physical performance, quality of life, electroencephalography and patient global impression in women affected by primary dysmenorrhoea.

Methods and analysis

This is a single-centre, parallel, randomised, double-blinded clinical trial protocol. 40 women affected by primary dysmenorrhoea will be randomised into two groups (active-tDCS or sham-tDCS). Then, 20 consecutive sessions of home-based self-administered tDCS will be performed. The assessments will occur at five time points: baseline, after the 20th sessions, at the first, second and third cycles after tDCS interventions (follow-ups). Primary outcome will be pain according to visual analogue scale. Quality of life, premenstrual symptoms screening, depression, anxiety, physical performance, electroencephalography and participants’ satisfaction will be the secondary outcomes. A mixed analysis of variance will calculate the effect of stimulation.

Ethics and dissemination

The study was approved by the ethics committee of the Federal University of Rio Grande do Norte (No. 6.037.756) and registered in the Brazilian Clinical Trials Registry (n° RBR-747k8vb). Participants may withdraw at any time without penalty. Free support will be available from the lead researcher if needed. All procedures will follow Good Clinical Practice and international ethical standards.

Trail registration

https://ensaiosclinicos.gov.br/rg/RBR-747k8vb

Development, Validation, and Usability of the Chatbot ESTOMABOT to Promote Self-care of People With Intestinal Ostomy

imageThis study aimed to describe the process of construction, validation, and usability of the chatbot ESTOMABOT to assist in the self-care of patients with intestinal ostomies. Methodological research was conducted in three phases: construction, validation, and usability. The first stage corresponded to the elaboration of a script through a literature review, and the second stage corresponded to face and content validation through a panel of enterostomal therapy nurses. In the third phase, the usability of ESTOMABOT was assessed with the participation of surgical clinic nurses, patients with intestinal elimination ostomies, and information technology professionals, using the System Usability Scale. The ESTOMABOT content reached excellent criteria of adequacy, with percentages of agreement equal to or greater than 90%, which were considered adequate, relevant, and representative. The evaluation of the content validity of the script using the scale content validity index/average proportion method reached a result above 0.90, and the Fleiss κ was excellent (P

Experiencias de madres con accidentes domésticos infantiles: consideraciones a la luz del Modelo de Adaptación de Roy

Objetivo principal: Describir las experiencias de las madres que vivieron accidentes domésticos que involucraron a sus hijos, a la luz del Modelo de Adaptación de Roy.  Método: Estudio cualitativo. Los datos fueron recolectados a través de entrevistas y sometidos a la técnica de análisis de contenido. Se utilizó como marco teórico el Modelo de Adaptación de Roy. Resultados principales: Participaron 17 madres, cuyos discursos fueron agrupados en tres categorías: enfrentar el desafío de salvar la vida de su hijo; reconocer el momento de (falta de) cuidado de su hijo; y aprender de sus errores. Conclusión principal: Se identificaron madres con dificultades para reconocer sus errores y posibles negligencias, que les atribuyeron la responsabilidad del accidente al hijo. Los enfermeros, cuando basan su práctica clínica en el Modelo de Adaptación de Roy, deben prestarles atención a las necesidades emocionales de los sistemas adaptativos de los involucrados.

Abordaje del dolor en pacientes con insuficiencia cardíaca

Objetivo: Describir el abordaje del dolor en pacientes con insuficiencia cardíaca, según lo encontrado en la literatura. Metodología: se realizó una investigación bibliográfica con búsqueda en las bases de datos MEDLINE, PUBMED, LILACS, CUIDEN, CINAHL, utilizando los descriptores Manejo del dolor, insuficiencia cardíaca y Automedicación, junto con el operador booleano AND. Se seleccionaron artículos en portugués, publicados entre 2010 y 2020, que respondieron al objetivo de la investigación. Las publicaciones duplicadas fueron ex-cluidas al final de las búsquedas en cada base de datos, obteniendo una muestra final de 31 artículos. Resultados: se encontró que el dolor se puede clasificar: 1) Según su naturaleza en nociceptivo (que puede ser somático y visceral), neuropático y mixto) y 2) Según su intensidad: en agudo, crónico o recurrente. Por lo tanto, el abordaje del dolor dependerá de su origen y de la necesidad del individuo.

Cuidado materno domiciliario en la prematuridad: revisión integradora

Objetivo principal: revisar las evidencias disponibles en la literatura sobre la prematuridad y sus especificidades para el cuidado. Metodología: revisión integradora en la Base de Datos de Literatura de América Latina y del Caribe en Ciencias de la Salud (Lilacs); Índice Acumulativo de Enfermería y Literatura de la Salud Aliada (Cinahl); Biblioteca Nacional de Medicina (NLM-PubMed); Base de Datos de Enfermería (BDEnf); con descriptores: Familia, Prematuridad, Comportamiento maternal, Cuidado del bebé. Resultados principales: Fueron encontrados 11 artículos en Lilacs; 3 en el Cinahl; 7 en PubMed; y 2 en BDEnf, totalizando 26 artículos. Se realizó una lectura comprensiva y un análisis crítico del contenido de los artículos. El proceso comparativo constante se fue realizado para organizar y consolidar los datos en categorías, utilizando técnicas de investigación cualitativas. Fueron encontradas tres categorías: Prematuridad; Atención materna en el domicilio; Impacto del nacimiento prematuro en la familia. Conclusión principal: el bebé prematuro es un niño de alto riesgo y necesita de un cuidado especial por parte de la madre para un periodo prolongado. Se requiere una atención especializada de los profesionales de la salud y de la familia para su desarrollo saludable.

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