Graft Failure After Coronary Artery Bypass Grafting and Its Association With Patient Characteristics and Clinical Events: A Pooled Individual Patient Data Analysis of Clinical Trials With Imaging Follow-Up

Circulation, Ahead of Print. BACKGROUND:Graft patency is the postulated mechanism for the benefits of coronary artery bypass grafting (CABG). However, systematic graft imaging assessment after CABG is rare, and there is a lack of contemporary data on the factors associated with graft failure and on the association between graft failure and clinical events after CABG.METHODS:We pooled individual patient data from randomized clinical trials with systematic CABG graft imaging to assess the incidence of graft failure and its association with clinical risk factors. The primary outcome was the composite of myocardial infarction or repeat revascularization occurring after CABG and before imaging. A 2-stage meta-analytic approach was used to evaluate the association between graft failure and the primary outcome. We also assessed the association between graft failure and myocardial infarction, repeat revascularization, or all-cause death occurring after imaging.RESULTS:Seven trials were included comprising 4413 patients (mean age, 64.4±9.1 years; 777 [17.6%] women; 3636 [82.4%] men) and 13 163 grafts (8740 saphenous vein grafts and 4423 arterial grafts). The median time to imaging was 1.02 years (Q1;Q3: 1.00;1.03). Graft failure occurred in 1487 (33.7%) patients and in 2190 (16.6%) grafts. Age (adjusted odds ratio [aOR], 1.08 [per 10-year increment] [95% CI, 1.01–1.15];P=0.03), female sex (aOR, 1.27 [95% CI, 1.08–1.50];P=0.004), and smoking (aOR, 1.20 [95% CI, 1.04–1.38];P=0.01) were independently associated with graft failure, whereas statins were associated with a protective effect (aOR, 0.74 [95% CI, 0.63–0.88];P

Leggi
Luglio 2023

Supply-side and demand-side factors influencing uptake of malaria testing services in the community: lessons for scale-up from a post-hoc analysis of a cluster randomised, community-based trial in western Kenya

Objectives
Maximising the impact of community-based programmes requires understanding how supply of, and demand for, the intervention interact at the point of delivery.

Design
Post-hoc analysis from a large-scale community health worker (CHW) study designed to increase the uptake of malaria diagnostic testing.

Setting
Respondents were identified during a household survey in western Kenya between July 2016 and April 2017.

Participants
Household members with fever in the last 4 weeks were interviewed at 12 and 18 months post-implementation. We collected monthly testing data from 244 participating CHWs and conducted semistructured interviews with a random sample of 70 CHWs.

Primary and secondary outcome measures
The primary outcome measure was diagnostic testing before treatment for a recent fever. The secondary outcomes were receiving a test from a CHW and tests done per month by each CHW.

Results
55% (n=948 of 1738) reported having a malaria diagnostic test for their recent illness, of which 38.4% were tested by a CHW. Being aware of a local CHW (adjusted OR=1.50, 95% CI: 1.10 to 2.04) and belonging to the wealthiest households (vs least wealthy) were associated with higher testing (adjusted OR=1.53, 95% CI: 1.14 to 2.06). Wealthier households were less likely to receive their test from a CHW compared with poorer households (adjusted OR=0.32, 95% CI: 0.17 to 0.62). Confidence in artemether–lumefantrine to cure malaria (adjusted OR=2.75, 95% CI: 1.54 to 4.92) and perceived accuracy of a malaria rapid diagnostic test (adjusted OR=2.43, 95% CI: 1.12 to 5.27) were positively associated with testing by a CHW. Specific CHW attributes were associated with performing a higher monthly number of tests including formal employment, serving more than 50 households (vs

Leggi
Giugno 2023

What follow-up interventions, programmes and pathways exist for minor stroke survivors after discharge from the acute setting? A scoping review

Objective
To identify the breadth and range of follow-up interventions currently provided to people after minor stroke with a focus on the definitions used for minor stroke, intervention components, intervention theory and outcomes used. These findings will inform the development and feasibility testing of a pathway of care.

Design
Scoping review.

Search strategy
The final search was run in January 2022. Five databases were searched—EMBASE, MEDLINE, CINAHL, British Nursing Index and PsycINFO. Grey literature was also searched. Title and abstract screening and full-text reviews were conducted by two researchers and a third was involved when differences of opinion existed. A bespoke data extraction template was created, refined and then completed. The Template for Intervention Description and Replication (TIDieR) checklist was used to describe interventions.

Results
Twenty-five studies, using a range of research methodologies were included in the review. A range of definitions were used for minor stroke. Interventions focused largely on secondary prevention and management of increased risk of further stroke. Fewer focused on the management of hidden impairments experienced after minor stroke. Limited family involvement was reported and collaboration between secondary and primary care was seldom described. The intervention components, content, duration and delivery were varied as were the outcome measures used.

Conclusion
There is an increasing volume of research exploring how best to provide follow-up care to people after minor stroke. Personalised, holistic and theory-informed interdisciplinary follow-up is needed that balances education and support needs with adjustment to life after stroke.

Leggi
Giugno 2023

Natural Course of Ruptured but Untreated Intracranial Aneurysms: A Multicenter 2-Year Follow-Up Study

Stroke, Ahead of Print. BACKGROUND:The current understanding of untreated ruptured intracranial aneurysms has been limited by study design and inaccurate patient data. Multicenter clinical registry studies on untreated ruptured intracranial aneurysms in Chinese patients are scarce. We aimed to calculate the mortality of patients with untreated ruptured intracranial aneurysms in a current, clearly defined hospital cohort in China, with emphasis on mortality predictors over a 2-year period.METHODS:Patients with saccular untreated ruptured intracranial aneurysms were identified from the Chinese Multicenter Cerebral Aneurysm Database, a multicenter, prospective, observational database registered in China, which involved 32 tertiary medical centers covering 4 northern Chinese provincial regions. Patients with intracranial aneurysms, regardless of ruptured status, shape, age, or comorbidities, were consecutively included in 12 of 32 medical centers between 2017 and 2020. Survival probabilities were computed using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were conducted to determine the risk factors for the cumulative 2-year mortality. We analyzed the reasons for treatment decisions stratified by demographic characteristics and clinical features.RESULTS:For 941 enrolled patients, 58.6% of patients died within 1 month of symptom onset; and 68.1% within 2 years. 98 patients underwent surgical repair during follow-up. Multivariate Cox regression analysis identified Hunt and Hess grades 3 to 5 (hazard ratio, 1.54 [95% CI, 1.01–2.35];P=0.047), loss of consciousness at symptom onset (hazard ratio, 1.56 [95% CI, 1.18–2.07];P=0.002), and largest aneurysm size of ≥5 mm (hazard ratio, 1.29 [95% CI, 1.05–1.59];P=0.014) as mortality predictors during the 2-year follow-up. Among patients who were successfully followed up, 42.6% (280) of them refused surgical treatment.CONCLUSIONS:Patients with poor Hunt and Hess grades, loss of consciousness at symptom onset, or largest aneurysms ≥5 mm in size showed a high mortality rate. A high number of treatment refusals was present in this study. These findings have implications for medical insurance policy, doctor-patient communication, and popular science education.

Leggi
Giugno 2023

Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability – a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project

Objectives
To study whether early and enhanced cooperation within the primary care centres (PCC) combined with workplace cooperation via a person-centred employer dialogue meeting can reduce days on sick leave compared with usual care manager contact for patients on sick leave because of common mental disorders (CMD). Secondary aim: to study lapse of CMD symptoms, perceived Work Ability Index (WAI) and quality of life (QoL) during 12 months.

Design
Pragmatic cluster randomised controlled trial, randomisation at PCC level.

Setting
28 PCCs in Region Västra Götaland, Sweden, with care manager organisation.

Participants
30 PCCs were invited, 28 (93%) accepted invitation (14 intervention, 14 control) and recruited 341 patients newly sick-listed because of CMD (n=185 at intervention, n=156 at control PCCs).

Intervention
Complex intervention consisting of (1) early cooperation among general practitioner (GP), care manager and a rehabilitation coordinator, plus (2) a person-centred dialogue meeting between patient and employer within 3 months. Control group: regular contact with care manager.

Main outcome measures
12 months net and gross number of sick leave days at group level. Secondary outcomes: 12 months depression, anxiety, stress symptoms, perceived WAI and QoL (EuroQoL-5 Dimensional, EQ-5D).

Results
No significant differences were found between intervention and control groups concerning days of sick leave (intervention net days of sick leave mean 102.48 (SE 13.76) vs control 96.29 (SE 12.38) p=0.73), return to work (HR 0.881, 95% CI 0.688 to 1.128), or CMD symptoms, WAI or EQ-5D after 12 months.

Conclusions
It is not possible to speed up CMD patients’ return to work or to reduce sick leave time by early and enhanced coordination among GP, care manager and a rehabilitation coordinator, combined with early workplace contact over and above what ‘usual’ care manager contact during 3 months provides.

Trial registration number
NCT03250026.

Leggi
Giugno 2023

Is proactive telephone-based breastfeeding peer support a cost-effective intervention? A within-trial cost-effectiveness analysis of the 'Ringing Up about Breastfeeding earlY (RUBY) randomised controlled trial

Objective
The ‘Ringing Up about Breastfeeding earlY’ (RUBY) randomised controlled trial showed increased breastfeeding at 6 months in participants who received the proactive telephone-based peer support breastfeeding intervention compared with participants allocated to receive standard care and supports. The present study aimed to evaluate if the intervention was cost-effective.

Design
A within-trial cost-effectiveness analysis.

Setting
Three metropolitan maternity services in Melbourne, Victoria, Australia.

Participants
First time mothers intending to breastfeed their infant (1152) and peer volunteers (246).

Intervention
The intervention comprised proactive telephone-based support from a peer volunteer from early postpartum up to 6 months. Participants were allocated to usual care (n=578) or the intervention (n=574).

Main outcome measures
Costs during a 6-month follow-up period including individual healthcare, breastfeeding support and intervention costs in all participants, and an incremental cost-effectiveness ratio.

Results
Costs per mother supported were valued at $263.75 (or $90.33 excluding costs of donated volunteer time). There was no difference between the two arms in costs for infant and mothers in healthcare and breastfeeding support costs. These figures result in an incremental cost-effectiveness ratio of $4146 ($1393 if volunteer time excluded) per additional mother breast feeding at 6 months.

Conclusion
Considering the significant improvement in breastfeeding outcomes, this intervention is potentially cost-effective. These findings, along with the high value placed on the intervention by women and peer volunteers provides robust evidence to upscale the implementation of this intervention.

Trial registration number
ACTRN12612001024831.

Leggi
Giugno 2023

Long-term impacts of an urban sanitation intervention on enteric pathogens in children in Maputo city, Mozambique: study protocol for a cross-sectional follow-up to the Maputo Sanitation (MapSan) trial 5 years postintervention

Introduction
We previously assessed the effect of an onsite sanitation intervention in informal neighbourhoods of urban Maputo, Mozambique on enteric pathogen detection in children after 2 years of follow-up (Maputo Sanitation (MapSan) trial, ClinicalTrials.gov: NCT02362932). We found significant reductions in Shigella and Trichuris prevalence but only among children born after the intervention was delivered. In this study, we assess the health impacts of the sanitation intervention after 5 years among children born into study households postintervention.

Methods and analysis
We are conducting a cross-sectional household study of enteric pathogen detection in child stool and the environment at compounds (household clusters sharing sanitation and outdoor living space) that received the pour-flush toilet and septic tank intervention at least 5 years prior or meet the original criteria for trial control sites. We are enrolling at least 400 children (ages 29 days to 60 months) in each treatment arm. Our primary outcome is the prevalence of 22 bacterial, protozoan, and soil transmitted helminth enteric pathogens in child stool using the pooled prevalence ratio across the outcome set to assess the overall intervention effect. Secondary outcomes include the individual pathogen detection prevalence and gene copy density of 27 enteric pathogens (including viruses); mean height-for-age, weight-for-age, and weight-for-height z-scores; prevalence of stunting, underweight, and wasting; and the 7-day period prevalence of caregiver-reported diarrhoea. All analyses are adjusted for prespecified covariates and examined for effect measure modification by age. Environmental samples from study households and the public domain are assessed for pathogens and faecal indicators to explore environmental exposures and monitor disease transmission.

Ethics and dissemination
Study protocols have been reviewed and approved by human subjects review boards at the Ministry of Health, Republic of Mozambique and the University of North Carolina at Chapel Hill. Deidentified study data will be deposited at https://osf.io/e7pvk/.

Trial registration number
ISRCTN86084138.

Leggi
Giugno 2023

Prevalence of Venous Infarction in Patients With Cerebral Venous Thrombosis: Baseline Diffusion-Weighted MRI and Follow-Up MRI

Stroke, Ahead of Print. BACKGROUND:A venous pattern of infarction on neuroimaging is used as a clue to undiagnosed cerebral venous thrombosis (CVT); prevention of venous infarction is a goal of CVT management; and venous infarction is a factor used for clinical prognostication. Despite widespread use of the term venous infarct, the prevalence of true venous infarction is unclear. Our primary aim was to determine the prevalence of venous infarction in patients with CVT. We also measured the prevalence of diffusion abnormality without infarction, vasogenic edema, and intracranial hemorrhage.METHODS:Single-center, retrospective cohort study using a registry of 110 consecutive patients admitted to hospital with cerebral venous thrombosis between 2004 and 2014. Inclusion criteria were brain magnetic resonance imaging (MRI) and contrast-enhanced venography at presentation, and repeat brain MRI ≥1 month later. Exclusion criteria were dural arteriovenous fistula, arteriovenous malformation, cavernous sinus thrombosis, or previous neurosurgical procedure. Main outcome was proportion of patients with venous infarction (irreversible ischemic injury) diagnosed using diffusion-weighted MRI at presentation, confirmed using T2-weighted fluid-attenuated inversion recovery MRI ≥1 month later, and reported with 95% CI using the Wilson score interval method. We also report the prevalence of transient diffusion MRI abnormality without infarction, vasogenic edema, and intracranial hemorrhage.RESULTS:Seventy-three patients met the inclusion criteria, and after exclusions, the final study population was 59 patients with median age 41 years (interquartile range, 32–57). Venous infarction occurred in 12% (7/59 [95% CI, 6%–23%]) of patients, and final infarct volume was >1 mL in only 5.1% (3/59) of patients. An additional 8% (5/59 [95% CI, 4%–18%]) of patients had a transient diffusion MRI abnormality without infarction. Prevalence of cerebral vasogenic edema and intracranial hemorrhage were 66% (39/59 [95% CI, 53%–77%]) and 54% (32/59 [95% CI, 41%–66%]), respectively.CONCLUSIONS:In patients with CVT, venous infarction is uncommon and venous infarcts are typically very small. Vasogenic edema and hemorrhage are more common consequences of CVT.

Leggi
Giugno 2023

Longitudinal assessment of the eating pattern of people with dementia and its association with problems for feeding and malnutrition: a prospective follow-up study protocol

Introduction
Dementia conditions the patient’s nutrition from the beginning and vice versa. Generating difficulties for feeding (FEDIF) will influence its evolution. There are currently few nutritional longitudinal studies in people with dementia. Most focus on problems already established. The Edinburgh Feeding Evaluation in Dementia (EdFED) Scale identifies FEDIF of patients with dementia by studying their behaviours while eating or being fed. It also indicates areas of potential clinical interventions.

Methods and analysis
Prospective multicentre observational study carried out in nursing homes, Alzheimer’s day care centres and primary healthcare centres. The study population will be dyads composed by the patient (diagnosed of dementia, over 65 years of age and who have feeding difficulties) and their family caregiver. Sociodemographic variables and nutritional status (body mass index, Mini Nutritional Assessment, blood test and calf and arm circumference) will be assessed. The Spanish version of the EdFED Scale will be completed and the presence of nursing diagnoses related to feeding behaviours will be collected. Follow-up will take place for 18 months.

Ethics and dissemination
All data will be carried out respecting European legislation 2016/679 in data protection, and the Spanish ‘Organic Law 3/2018 of December 2005’. The clinical data will be kept segregated and encrypted. The informed consent has been obtained. The research has been authorised by the Costa del Sol Health Care District on 27 February 2020 and the Ethics Committee on 2 March 2021. It has obtained funding from the Junta de Andalucía on 15 February 2021. Findings of the study will be presented at provincial, national and international conferences and published in peer-reviewed journals.

Leggi
Maggio 2023