Longitudinal cohort study investigating neurodevelopmental and socioemotional outcomes in school-entry aged children after open heart surgery in Australia and New Zealand: the NITRIC follow-up study protocol

Introduction
Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children

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Agosto 2023

Fractional Flow Reserve–Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial

Circulation, Ahead of Print. BACKGROUND:Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI.METHODS:FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke.RESULTS:A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98–1.83];P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6–1.7];P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4–1.7];P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1–2.7];P=0.02).CONCLUSIONS:At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT02100722.

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Agosto 2023

Misdiagnosis Might Harm up to 800 000 US Patients Annually

About 795 000 people die or are permanently disabled each year due to diagnostic errors and related harms across clinical settings, according to estimates based on nationally representative disease incidence data for 2012 to 2014. Conservative methods suggest the number might be lower, at approximately 549 000 people harmed, according to the analysis.

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Agosto 2023

Management of acute non-specific low back pain in the emergency department: do emergency physicians follow the guidelines? Results of a cross-sectional survey

Objectives
Clinical guidelines for acute non-specific low back pain (LBP) recommend avoiding imaging studies or invasive treatments and to advise patients to stay active. The aim of this study was to evaluate the management of acute non-specific LBP in the emergency departments (ED).

Setting
We invited all department chiefs of Swiss EDs and their physician staff to participate in a web-based survey using two clinical case vignettes of patients with acute non-specific LBP presenting to an ED. In both cases, no neurological deficits or red flags were present. Guideline adherence and low-value care was defined based on current guideline recommendations.

Results
In total, 263 ED physicians completed at least one vignette, while 212 completed both vignettes (43% residents, 32% senior/attending physicians and 24% chief physicians). MRI was considered in 31% in vignette 1 and 65% in vignette 2. For pain management, non-steroidal anti-inflammatory drugs, paracetamol and metamizole were mostly used. A substantial proportion of ED physicians considered treatments with questionable benefit and/or increased risk for adverse events such as oral steroids (vignette 1, 12% and vignette 2, 19%), muscle relaxants (33% and 38%), long-acting strong opioids (25% and 33%) and spinal injections (22% and 43%). Although guidelines recommend staying active, 72% and 67% of ED physicians recommended activity restrictions.

Conclusion
Management of acute non-specific LBP in the ED was not in agreement with current guideline recommendations in a substantial proportion of ED physicians. Overuse of imaging studies, the use of long-acting opioids and muscle relaxants, as well as recommendations for activity and work restrictions were prevalent and may potentially be harmful.

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Agosto 2023

What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D studys patient-level data with fidelity to the original research protocol

Objective
Reanalyse the patient-level data set of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study with fidelity to the original research protocol and related publications.

Design
The study was open label and semirandomised examining the effectiveness of up to four optimised and increasingly aggressive, antidepressant therapies in depressed adults. Patients who failed to gain adequate relief from their level 1 trial on the SSRI citalopram could receive up to three additional treatment trials in levels 2–4.

Setting
41 North American psychiatry and primary care treatment centres.

Participants
4041 adults screened positive for major depressive disorder. In contrast to most clinical trials, STAR*D enrolled patients seeking care (vs recruited) and included patients with a wide range of common comorbid medical and psychiatric conditions to enhance the generalisability of findings to real-world clinical practice.

Interventions
STAR*D evaluated the relative effectiveness of 13 antidepressants therapies in treatment levels 2–4 for depressed patients who failed to gain adequate benefit from their level 1 medication trial.

Main outcome measures
According to the STAR*D protocol, the primary outcome was remission, defined as a score

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Luglio 2023

Exploring participant attrition in a longitudinal follow-up of older adults: the Global Longitudinal Study of Osteoporosis in Women (GLOW) Hamilton cohort

Objective
We explored the magnitude of attrition, its pattern and risk factors for different forms of attrition in the cohort from the Global Longitudinal Study of Osteoporosis in Women.

Design
Prospective cohort study.

Setting
Participants were recruited from physician practices in Hamilton, Ontario.

Participants
Postmenopausal women aged ≥55 years who had consulted their primary care physician within the last 2 years.

Outcome measures
Time to all-cause, non-death, death, preventable and non-preventable attrition.

Results
All 3985 women enrolled in the study were included in the analyses. The mean age of the cohort was 69.4 (SD: 8.9) years. At the end of the follow-up, 30.2% (1206/3985) of the study participants had either died or were lost to follow-up. The pattern of attrition was monotone with most participants failing to return after a missed survey. The different types of attrition examined shared common risk factors including age, smoking and being frail but differed on factors such as educational level, race, hospitalisation, quality of life and being prefrail.

Conclusion
Attrition in this ageing cohort was selective to some participant characteristics. Minimising potential bias associated with such non-random attrition would require targeted measures to achieve maximum possible follow-rates among the high-risk groups identified and dealing with specific reasons for attrition in the study design and analysis.

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Luglio 2023

Are trajectories of depressive symptoms during the first half of drug-sensitive pulmonary tuberculosis treatment associated with loss to follow-up? A secondary analysis of longitudinal data

Objective
The objective of this study was to identify trajectories of depressive symptoms (DSs) during the first half of drug-sensitive pulmonary tuberculosis (PTB) treatment and examine their association with loss to follow-up (LTFU) in the second half.

Design
This study involved a secondary analysis of longitudinal data to identify potential trajectories of DS and their relationship with LTFU.

Setting
The study was conducted in first and second-level health centres located in San Juan de Lurigancho, Lima, Peru.

Participants
Anonymised data from 265 individuals, including monthly measures of DSs from diagnosis to the completion of treatment, initiation of treatment for multidrug resistant TB, LTFU or death, were collected.

Results
Three trajectories were identified: ‘declining’, ‘growth’ and ‘high’. These trajectories were observed in 182 (68.7%), 53 (20%) and 30 (11.3%) of the 265 individuals, respectively, during the first half of PTB treatment. Compared with those with a ‘declining’ trajectory, individuals with a ‘growth’ trajectory had a higher likelihood of experiencing LTFU during the second half of PTB treatment, after controlling for sociodemographic factors and at least weekly alcohol use (OR 3.9; 95% CI 1.09 to 13.97, p=0.036).

Conclusions
The findings suggest that a trajectory of increasing DSs during the first half of PTB treatment is associated with a higher risk of LTFU during the second half.

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Luglio 2023

Complications and risk factors on midline catheters follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study)

Introduction
The midline catheter (MC) is an increasingly popular device used commonly for patients with difficult venous access or those who require infusion for more than 6 days. Little is known about complications such as infection, thrombosis or occlusion for inpatient and home care patient. This protocol presents the follow-up of non-intensive care unit patients with an MC. The aim is to identify complications and search for risk factors associated with these complications.

Method and analysis
A prospective observational design is used for the follow-up of 2000 patients from 13 centres in France. Each practitioner (inserting clinician, anaesthetist nurse, hospital nurse and home nurse) will fill out a logbook to report each care made (eg, number of saline flushes, dress maintenance) on the MC and if any complications occurred. The incidence of complications (ie, infections, thrombosis or occlusions) will be expressed by the total number of events per 1000 catheter days. The period of recruitment began in December 2019 for a duration of 2 years. An extension of the inclusion period of 1 year was obtained.

Ethics and dissemination
This study received the approval of the Committee for the Protection of Persons of Nord Ouest IV (No EudraCT/ID-RCB : 2019-A02406-51). It was registered at clinical trials (NCT04131088). It is planned to communicate results at conferences and in a peer-reviewed journal.

Trial registration number
NCT04131088.

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Luglio 2023

Workplace socioeconomic characteristics and coronary heart disease: a nationwide follow-up study

Objectives
Important gaps in previous research include a lack of studies on the association between socioeconomic characteristics of the workplace and coronary heart disease (CHD).
We aimed to examine two contextual factors in association with individuals’ risk of CHD: the mean educational level of all employees at each individual’s workplace (educationwork) and the neighbourhood socioeconomic characteristics of each individual’s workplace (neighbourhood SESwork).

Design
Nationwide follow-up/cohort study.

Setting
Nationwide data from Sweden.

Participants
All individuals born in Sweden from 1943 to 1957 were included (n=1 547 818). We excluded individuals with a CHD diagnosis prior to 2008 (n=67 619), individuals without workplace information (n=576 663), individuals lacking residential address (n=4139) and individuals who had unknown parents (n=7076). A total of 892 321 individuals were thus included in the study (426 440 men and 465 881 women).

Primary and secondary outcome measures
The outcome variable was incident CHD during follow-up between 2008 and 2012. The association between educationwork and neighbourhood SESwork and the outcome was explored using multilevel and cross-classified logistic regression models to determine ORs and 95% CIs, with individuals nested within workplaces and neighbourhoods. All models were conducted in both men and women and were adjusted for age, income, marital status, educational attainment and neighbourhood SESresidence.

Results
Low (vs high) educationwork was significantly associated with increased CHD incidence for both men (OR 1.29, 95% CI 1.23 to 1.34) and women (OR 1.38, 95% CI 1.29 to 1.47) and remained significant after adjusting for potential confounders. These findings were not replicable for the variable neighbourhood SESwork.

Conclusions
Workplace socioeconomic characteristics, that is, the educational attainment of an individual’s colleagues, may influence CHD risk, which represents new knowledge relevant to occupational health management at workplaces.

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Luglio 2023