Long-term impact on cardiopulmonary function and quality of life among patients recovered from SARS-CoV-2 infection in a 6-month follow-up period in Lima, Peru: FUNCTION cohort study protocol

Introduction
The sequelae of COVID-19 have been described as a multisystemic condition, with a great impact on the cardiovascular and pulmonary systems with abnormalities in pulmonary function tests, such as lower diffusing capacity of the lung for carbon monoxide (DLco) levels and pathological patterns in spirometry; persistence of radiological lesions; cardiac involvement such as myocarditis and pericarditis; and an increase in mental disorders such as anxiety and depression. Several factors, such as infection severity during the acute phase as well as vaccination status, have shown some variable effects on these post-COVID-19 conditions, mainly at a clinical level such as symptoms persistence. Longitudinal assessments and reversibility of changes across the spectrum of disease severity are required to understand the long-term impact of COVID-19.

Methods and analysis
A prospective cohort study aims to assess the impact of SARS-CoV-2 infection on cardiopulmonary function and quality of life after the acute phase of the disease over a 6-month follow-up period. Sample size was calculated to recruit 200 participants with confirmatory COVID-19 tests who will be subsequently classified according to infection severity. Four follow-up visits at baseline, month 1, month 3 and month 6 after discharge from the acute phase of the infection will be scheduled as well as procedures such as spirometry, DLco test, 6-minute walk test, chest CT scan, echocardiogram, ECG, N-terminal pro-B-type natriuretic peptide measurement and RAND-36 scale. Primary outcomes are defined as abnormal pulmonary function test considered as DLco

Leggi
Aprile 2023

Direct active rehabilitation after reverse total shoulder arthroplasty: an international multicentre prospective cohort safety study with 1-year follow up

Objectives
To gain insight in the safety of direct active rehabilitation without immobilisation in patients undergoing reverse total shoulder arthroplasty without subscapularis reattachment, measured by the occurrence of complications until 1-year follow up. Next, to explore improvement in shoulder function and in patient-reported outcome measures.

Design
An international multicentre prospective cohort safety study.

Setting
Patients indicated for reverse total shoulder arthroplasty, visiting the orthopaedics outpatient clinic at two hospitals in the Netherlands and one hospital in Curacao between January 2019 and July 2021, were selected.

Participants
100 patients (68% female, mean age 74±7.0 years) undergoing unilateral primary shoulder replacement were included if: ≥50 years, diagnosed with shoulder osteoarthritis, rotator cuff arthropathy or avascular necrosis, and selected for reverse total shoulder arthroplasty. A sling was used for only 1 day, followed by a progressive active rehabilitation for ≥12 weeks with no precautions.

Main outcome measures
Complications, range of motion and patient-reported outcome measures (Oxford Shoulder Score, Pain Numeric Rating Scale and EuroQol-5D for quality of life). Patients were evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively.

Results
In total, 17 complications were registered (17.0%) including five (5.0%) categorised as potentially related to the rehabilitation strategy: one dislocation, one acromion fracture and three cases with persistent pain. Anteflexion, abduction and external rotation, pain scores and the Oxford Shoulder Score all improved significantly (p

Leggi
Aprile 2023

Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age

Introduction
Therapeutic hypothermia (TH) became the standard of care treatment for neonates with moderate and severe neonatal encephalopathy (NE) in most industrialized countries about 10 years ago. Although TH is effective in reducing mortality and the incidence of severe developmental disabilities, the recent literature converges in reporting frequent cognitive and behavioural difficulties at school entry in children with NE-TH. Although these challenges are deemed minor compared with cerebral palsy and intellectual disability, their impacts on a child’s self-determination and family’s well-being are quite significant. Therefore, the nature and extent of these difficulties need to be comprehensively described so that appropriate care can be offered.

Methods and analysis
The current study will be the largest follow-up study of neonates with NE treated with TH to characterize their developmental outcomes and associated brain structural profiles at 9 years of age. Specifically, we will compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, peer problems, brain volume, cortical features, white matter microstructure and myelination between children with NE-TH and matched peers without NE. Associations of perinatal risk factors and structural brain integrity with cognitive, behavioural and psycho-emotional deficits will be evaluated to inform about the potential aggravating and protective factors associated with function.

Ethics and dissemination
This study is supported by the Canadian Institute of Health Research (202203PJT-480065-CHI-CFAC-168509), and received approval from the Pediatric Ethical Review Board of the McGill University Health Center (MP-37-2023-9320). The study findings will be disseminated in scientific journals and conferences and presented to parental associations and healthcare providers to inform best practices.

Trial registration number
NCT05756296.

Leggi
Aprile 2023

C reactive protein-guided prescription of antibiotics for children under 12 years with respiratory symptoms in Kyrgyzstan: protocol for a randomised controlled clinical trial with 14 days follow-up

Introduction
While lower respiratory tract infections are the main cause of death for children under 5 globally, only a small proportion of children with respiratory tract infections need antibiotics. Overuse of antibiotics globally is leading to increasing rates of antibiotic resistance. In Kyrgyzstan, healthcare workers regularly prescribe antibiotics when clinical uncertainty is present to err on the side of caution. Targeting antibiotic use with biomarkers of inflammation such as C reactive protein (CRP) testing at the point-of-care test (POCT) has been shown to reduce antibiotic use in general, but only few studies have been done in children and no studies exist from Central Asia. This study aims to assess whether the use of a CRP POCT can safely decrease prescription of antibiotics for children with acute respiratory symptoms in primary level healthcare centres in Kyrgyzstan.

Methods and analysis
Multicentre, open-label, individually randomised, controlled clinical trial with 14 days follow-up (follow-up by phone on days 3, 7 and 14) in rural lowland Chui and highland Naryn regions of Kyrgyzstan. The population are children aged 6 months to 12 years attending the primary level healthcare centres during normal business hours with acute respiratory symptoms. CRP POCT equipment will be supplied to healthcare centres, along with a short training session in CRP use, including the interpretation of results to support the clinical evaluation of the child with acute respiratory infection. The primary outcomes are the proportion of patients prescribed an antibiotic within 14 days of index consultation (superiority analysis) and days to recovery (non-inferiority analysis). Secondary outcomes are antibiotics prescribed at index consultation, reconsultations, hospital admission and vital status within 14 days. Analysis of the first primary outcome, antibiotic use, will be intention to treat using a logistic regression model. Analysis of the second primary outcome, days to recovery, will be per protocol using a linear regression model and a non-inferiority margin of 1 day.

Ethics and dissemination
The study was approved on 18 June 2021 by the Ethics Committee (ref: no. 1) of the National Centre of Maternity and Childhood Care, Bishkek, Kyrgyzstan. The results of the study regardless of the conclusion will be presented at international conferences and published in peer-reviewed scientific medical journals along with policy briefs and technical reports.

Trial registration number
NCT05195866.

Leggi
Aprile 2023

Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP): protocol for a multi-centre, longitudinal, observational study to identify clinical features that are predictive of sarcoidosis progression

Introduction
Sarcoidosis is a pulmonary and systemic granulomatous disease with a wide range of potential outcomes, from spontaneous resolution to end-stage organ damage and death. Currently, clinicians have no easy-to-use risk stratification tools for important clinical outcomes in sarcoidosis, such as progressive lung disease. This study will address two clinical practice needs: (1) development of a risk calculator that provides an estimate of the likelihood of pulmonary progression in sarcoidosis patients during the follow-up period and (2) determine the optimal interval for serial clinical monitoring (eg, 6, 12, 18 months) using these risk prediction tools.

Methods and analysis
The Risk Indicators of Sarcoidosis Evolution-Unified Protocol study is a National Institutes of Health-sponsored, longitudinal observational study of adults with pulmonary sarcoidosis who will be enrolled at five US tertiary care centres. Participants will be evaluated at approximately 6-month intervals for up to 60 months with collection of lung function, blood samples and clinical data. The target sample size is 557 and the primary objective is to determine which clinical features measured during a routine clinic visit carry the most prognostic information for predicting clinical progression of pulmonary sarcoidosis over the follow-up period. The primary outcome measure will be quantified by a clinically meaningful change in forced vital capacity, forced expiratory volume in 1 s or diffusing capacity of the lung for carbon monoxide. The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment modelling for progression of pulmonary sarcoidosis over the follow-up period.

Ethics and dissemination
The study protocol has been approved by the Institutional Review Boards at each centre and the reliance Institutional Review Board overseeing the study (WCG, Protocol #20222400). Participants will provide informed consent prior to enrolment. Results will be disseminated via publication in a relevant peer-reviewed journal.

Trial registration number
NCT05567133.

Leggi
Aprile 2023

Loss to 5-year follow-up in the population-based Telemark Study: risk factors and potential for bias

Objectives
This study aimed to characterise participants lost to follow-up and identify possible factors associated with non-participation in a prospective population-based study of respiratory health in Norway. We also aimed to analyse the impact of potentially biased risk estimates associated with a high proportion of non-responders.

Design
Prospective 5-year follow-up study.

Setting
Randomly selected inhabitants from the general population of Telemark County in south-eastern Norway were invited to fill in a postal questionnaire in 2013. Responders in 2013 were followed-up in 2018.

Participants
16 099 participants aged 16–50 years completed the baseline study. 7958 responded at the 5-year follow-up, while 7723 did not.

Main outcome measures
2 test was performed to compare demographic and respiratory health-related characteristics between those who participated in 2018 and those who were lost to follow-up. Adjusted multivariable logistic regression models were used to assess the relationship between loss to follow-up, background variables, respiratory symptoms, occupational exposure and interactions, and to analyse whether loss to follow-up leads to biased risk estimates.

Results
7723 (49%) participants were lost to follow-up. Loss to follow-up was significantly higher for male participants, those in the youngest age group (16–30 years), those in lowest education level category and among current smokers (all p

Leggi
Marzo 2023

Women and health professionals perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study

Objectives
Women of low socioeconomic status have been described as having suboptimal prenatal care, which in turn has been associated with poor pregnancy outcomes. Many types of conditional cash transfer (CCT) programmes have been developed, including programmes to improve prenatal care or smoking cessation during pregnancy, and their effects demonstrated. However, ethical critiques have included paternalism and lack of informed choice. Our objective was to determine if women and healthcare professionals (HPs) shared these concerns.

Design
Prospective qualitative research.

Setting
We included economically disadvantaged women, as defined by health insurance data, who participated in the French NAITRE randomised trial assessing a CCT programme during prenatal follow-up to improve pregnancy outcomes. The HP worked in some maternities participating in this trial.

Participants
26 women, 14 who received CCT and 12 who did not, mostly unemployed (20/26), and – 7 HPs.

Interventions
We conducted a multicentre cross-sectional qualitative study among women and HPs who participated in the NAITRE Study to assess their views on CCT. The women were interviewed after childbirth.

Results
Women did not perceive CCT negatively. They did not mention feeling stigmatised. They described CCT as a significant source of aid for women with limited financial resources. HP described the CCT in less positive terms, for example, expressing concern about discussing cash transfer at their first medical consultation with women. Though they emphasised ethical concerns about the basis of the trial, they recognised the importance of evaluating CCT.

Conclusions
In France, a high-income country where prenatal follow-up is free, HPs were concerned that the CCT programme would change their relationship with patients and wondered if it was the best use of funding. However, women who received a cash incentive said they did not feel stigmatised and indicated that these payments helped them prepare for their baby’s birth.

Trial registration number
NCT02402855

Leggi
Marzo 2023

Extended Follow-up of Microbiome Therapeutic SER-109 for Recurrent Clostridioides difficile Infection

To the Editor The ECOSPOR III trial compared an investigational microbiome therapy (SER-109) with placebo for the treatment of recurrent Clostridioides difficile infection, with results on recurrence through 24 weeks published recently in JAMA. Although it is encouraging to see a new agent for treatment of recurrent C difficile infection, we have some questions about this study. First, the inclusion criteria mandated more than 3 episodes of C difficile infection within the last year, the most recent of which could be treated with a maximum of 10 to 21 days of therapy with either vancomycin or fidaxomicin. Yet the 2017 and 2021 Infectious Diseases Society of America (IDSA) guidelines suggested that when vancomycin is used to treat such patients, it should be tapered and/or pulsed or followed with additional therapy (eg, rifaximin). Therefore, for the 73% of participants who received vancomycin, the length of therapy may have been inappropriately short, which may have contributed to the 47.3% treatment failure and recurrence rate observed.

Leggi
Marzo 2023

Extended Follow-up of Microbiome Therapeutic SER-109 for Recurrent Clostridioides difficile Infection—Reply

In Reply Dr Hamilton and colleagues question why taper/pulse regimens of vancomycin were not used in the ECOSPOR III trial for patients with recurrent C difficile infection. Vancomycin has excellent bactericidal activity against C difficile bacteria with no detectable toxin concentrations by day 4, but has no activity against C difficile spores, which germinate in a disrupted microbiome, leading to C difficile infection. The rationale for taper/pulse regimens is to allow microbiome diversification with decreasing antibiotic exposure.

Leggi
Marzo 2023

Thirty-year follow-up of the NICHD Study of Early Child Care and Youth Development (SECCYD): the challenges and triumphs of conducting in-person research at a distance

Purpose
The purpose of the current study, The National Institute of Child Health and Human Development (NICHD) Study of Health in Early and Adult Life (SHINE), was to build on the landmark Study of Early Child Care and Youth Development (SECCYD), a longitudinal birth cohort initiated in 1991, by conducting a health-focused follow-up of the now adult participants. This effort has produced an invaluable resource for the pursuit of life course research examining links between early life risk and resilience factors and adulthood health and disease risk.

Participants
Of the 927 NICHD SECCYD participants available for recruitment in the current study, 705 (76.1%) participated in the study. Participants were between 26 and 31 years and living in diverse geographic locations throughout the USA.

Findings to date
In descriptive analyses, the sample exhibited risk on health status indicators, especially related to obesity, hypertension and diabetes. Of particular concern, the prevalence of hypertension (29.4%) and diabetes (25.8%) exceeded national estimates in similar-age individuals. Health behaviour indicators generally tracked with the parameters of poor health status, showing a pattern of poor diet, low activity and disrupted sleep. The juxtaposition of the sample’s relatively young age (mean=28.6 years) and high educational status (55.6% college educated or greater) with its poor health status is noteworthy, suggesting a dissociation between health and factors that are typically health protective. This is consistent with observed population health trends, which show a worsening of cardiometabolic health status in younger generations of Americans.

Future plans
The current study, SHINE, lays the groundwork for future analyses in which the uniquely robust measures collected as a part of the original NICHD SECCYD will be leveraged to pinpoint specific early life risk and resilience factors as well as the correlates and potential mechanisms accounting for variability in health and disease risk indicators in young adulthood.

Leggi
Marzo 2023