Tag: pubmed

Neurology. 2021 May 5:10.1212/WNL.0000000000012108. doi: 10.1212/WNL.0000000000012108. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare how structural MRI, Fluorodeoxyglucose (FDG), and Flortaucipir (FTP) PET signal predict cognitive decline in high-amyloid versus low-amyloid participants with the goal of determining which biomarker combination would result in the highest increase of statistical power for prevention trials.

METHODS: In this prospective cohort study, we analyzed data from clinically-normal adults from the Harvard Aging Brain Study with MRI, FDG, FTP, and PiB-PET acquired within a year, and prospective cognitive evaluations over a mean three-year follow-up. We focused analyses on pre-defined regions-of-interest: inferior temporal, isthmus cingulate, hippocampus, and entorhinal cortex. Cognition was assessed using the Preclinical Alzheimer’s Cognitive Composite (PACC5). We evaluated the association between biomarkers and cognitive decline using linear-mixed-effect models with random intercepts and slopes, adjusting for demographics. We generated power curves simulating prevention trials.

RESULTS: Data from 131 participants [52 females, 73.98±8.29 years old] were analyzed in the study. In separate models, most biomarkers had a closer association with cognitive decline in the high-PiB compared to the low-PiB participants. A backward stepwise regression including all biomarkers demonstrated that only neocortical PiB, entorhinal FTP, and entorhinal FDG were independent predictors of subsequent cognitive decline. Power analyses revealed that using both high-PiB and low entorhinal FDG as inclusion criteria reduced 3-fold the number of participants needed in a hypothetical trial compared to using only high-PiB.

DISCUSSION: In preclinical Alzheimer’s disease, entorhinal hypometabolism is a strong and independent predictor of subsequent cognitive decline, making FDG a potentially useful biomarker to increase power in clinical trials.

CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in people with preclinical Alzheimer’s disease, entorhinal hypometabolism identified by FDG-PET is predictive of subsequent cognitive decline.

PMID:33952655 | DOI:10.1212/WNL.0000000000012108

Arch Dis Child Fetal Neonatal Ed. 2021 May 5:fetalneonatal-2020-321299. doi: 10.1136/archdischild-2020-321299. Online ahead of print.

ABSTRACT

BACKGROUND: Parenteral nutrition is commonly administered during therapeutic hypothermia. Randomised trials in critically ill children indicate that parenteral nutrition may be harmful.

OBJECTIVE: To examine the association between parenteral nutrition during therapeutic hypothermia and clinically important outcomes.

DESIGN: Retrospective, population-based cohort study using the National Neonatal Research Database; propensity scores were used to create matched groups for comparison.

SETTING: National Health Service neonatal units in England, Scotland and Wales.

PARTICIPANTS: 6030 term and near-term babies, born 1/1/2010 and 31/12/2017, who received therapeutic hypothermia; 2480 babies in the matched analysis.

EXPOSURE: We compared babies that received any parenteral nutrition during therapeutic hypothermia with babies that did not.

MAIN OUTCOME MEASURES: Primary outcome: blood culture confirmed late-onset infection; secondary outcomes: treatment for late onset infection, necrotising enterocolitis, survival, length of stay, measures of breast feeding, hypoglycaemia, central line days, time to full enteral feeds, discharge weight.

RESULTS: 1475/6030 babies (25%) received parenteral nutrition. In comparative matched analyses, the rate of culture positive late onset infection was higher in babies that received parenteral nutrition (0.3% vs 0.9%; difference 0.6; 95% CI 0.1, 1.2; p=0.03), but treatment for presumed infection was not (difference 0.8%, 95% CI -2.1 to 3.6, p=0.61). Survival was higher in babies that received parenteral nutrition (93.1% vs 90.0%; rate difference 3.1, 95% CI 1.5, 4.7; p<0.001).

CONCLUSIONS: Receipt of parenteral nutrition during therapeutic hypothermia is associated with higher late-onset infection but lower mortality. This finding may be explained by residual confounding. Research should address the risks and benefits of parenteral nutrition in this population.

PMID:33952628 | DOI:10.1136/archdischild-2020-321299

BMJ Support Palliat Care. 2021 May 5:bmjspcare-2020-002670. doi: 10.1136/bmjspcare-2020-002670. Online ahead of print.

ABSTRACT

OBJECTIVES: The Prognosis in Palliative care Study II (PiPS2) was a large multicentre observational study validating prognostic tools in patients with advanced cancer. Many palliative care studies fail to reach their recruitment target. To inform future studies, PiPS2 rigorously monitored and identified any potential recruitment barriers.

METHODS: Key recruitment stages (ie, whether patients were eligible for the study, approached by the researchers and whether consent was obtained for enrolment) were monitored via comprehensive screening logs at participating sites (inpatient hospices, hospitals and community palliative care teams). The reasons for patients’ ineligibility, inaccessibility or decision not to consent were documented.

RESULTS: 17 014 patients were screened across 27 participating sites over a 20-month recruitment period. Of those, 4642 (27%) were ineligible for participation in the study primarily due to non-cancer diagnoses. Of 12 372 eligible patients, 9073 (73%) were not approached, the most common reason being a clinical decision not to do so. Other reasons included patients’ death or discharge before they were approached by the researchers. Of the 3299 approached patients, 1458 (44%) declined participation mainly because of feeling too unwell, experiencing severe distress or having other competing priorities. 11% (n=1841/17 014) of patients screened were enrolled in the study, representing 15% (n=1841/12 372) of eligible patients. Different recruitment patterns were observed across inpatient hospice, hospital and community palliative care teams.

CONCLUSIONS: The main barrier to recruitment was ‘accessing’ potentially eligible patients. Monitoring key recruitment stages may help to identify barriers and facilitators to enrolment and allow results to be put into better context.

TRIAL REGISTRATION NUMBER: ISRCTN13688211.

PMID:33952580 | DOI:10.1136/bmjspcare-2020-002670

Heart. 2021 May 5:heartjnl-2020-318676. doi: 10.1136/heartjnl-2020-318676. Online ahead of print.

ABSTRACT

OBJECTIVE: Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement.

METHODS: CLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05.

RESULTS: Both QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1-37.5 points and 33.3%-50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for <10% vs ≥10% burden, p<0.001 for <20% vs ≥20% burden). Cardiovascular hospitalisations were significantly decreased after ablation (42%, p=0.001). Patients without substantial improvement in AFEQT (55/301, 18.2%) had higher AFEQT and CHA₂DS₂-VASc scores at baseline, and higher AF burden following PVI.

CONCLUSIONS: QOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation.

TRIAL REGISTRATION NUMBER: NCT03062046.

PMID:33952593 | DOI:10.1136/heartjnl-2020-318676

Lupus Sci Med. 2021 May;8(1):e000467. doi: 10.1136/lupus-2020-000467.

ABSTRACT

OBJECTIVES: Cardiovascular complications became a notable cause of morbidity and mortality in patients with lupus as therapeutic advancements became more efficient at managing other complications. The Appalachian community in Kentucky has a higher prevalence of traditional cardiovascular risk factors, predisposing them to cardiovascular events. Namely, the mean body mass index of the members of the Kentucky Appalachian community was reported at 33 kg/m² and 94.3% of male members of this community use tobacco. We sought to identify risk factors that predispose patients with lupus to cardiovascular morbidities and examine the effect of immunomodulatory drugs.

METHODS: We identified 20 UKHS patients having both a lupus diagnosis and experienced at least one cardiovascular event. We chose three controls matched for birth-year ±5 years to each case. In a case-control design, we analysed lupus manifestations, cardiovascular risk factors and immunosuppressive therapies. We collected Systemic Lupus Erythematosus Disease Activity Index 2000 disease activity index during the cardiovascular event.

RESULTS: We identified 308 patients with lupus from among all University of Kentucky Health System patients. 20 (6.5%) of such patients with lupus were confirmed to cardiovascular complication. Of those 20, 7 (35%) had experienced myocardial infarction, 10 (50%) had experienced stroke and 4 (20%) had peripheral ischaemia. Tobacco use and male gender were the only traditional cardiovascular risk factors higher in the cases group. Hydroxychloroquine and steroids were less utilised in the cases than in the controls (70% vs 100% in hydroxychloroquine, 30% vs 82% in steroids). Venous thrombosis was found to be significantly higher in the cases. On multivariate analysis, venous thrombosis remained significant.

CONCLUSION: Despite tobacco use partially explaining the increased risk of cardiovascular disease among the cases group, the higher prevalence of venous thrombosis in the cases group suggests lupus as a potential additional risk factor of cardiovascular morbidity among patients with lupus in this Appalachian community.

PMID:33952624 | DOI:10.1136/lupus-2020-000467

BMJ Open. 2021 May 5;11(5):e044856. doi: 10.1136/bmjopen-2020-044856.

ABSTRACT

INTRODUCTION: Brain-related visual impairments, also known as cerebral visual impairment (CVI), are related to damage or poor function in the vision-related areas of the brain. There is broad agreement that CVI is an appropriate term to describe visual impairments that are not accounted by disorders of the eye or optic nerve, but differences remain as to which impairments can be included in this term. The CVI project is a programme of work that includes the development of a complex intervention to share knowledge with teachers, so that they can make both targeted and universal changes to support children with CVI. A feasibility study for a cluster-randomised controlled trial to evaluate this intervention is underway. This paper describes the protocol for an accompanying process evaluation to explore how the intervention is implemented and provide context for the interpretation of the feasibility trial outcomes.

METHODS AND ANALYSIS: A logic model has been developed to guide data collection. Both qualitative and quantitative data will be collected to assess the feasibility and acceptability of the intervention, the study design and explore how any changes that occur are brought about. Interviews with key primary school staff and parents will investigate responses to the intervention and trial processes. Surveys will collect data on intervention implementation and knowledge of CVI. Photographs of classroom walls will document any changes to visual clutter and document analysis will look for changes to school special educational needs and disability (SEND) policies.

ETHICS AND DISSEMINATION: Ethical approval was granted by the University of Bristol Faculty of Health Sciences Ethics Committee. Findings will contribute to the development of a full-scale cluster-randomised controlled trial to assess the effectiveness of the intervention with adequate statistical power. The results will also support the refinement of the intervention and its underlying theory.

PMID:33952549 | DOI:10.1136/bmjopen-2020-044856

BMJ Open. 2021 May 5;11(5):e045018. doi: 10.1136/bmjopen-2020-045018.

ABSTRACT

INTRODUCTION: Qualitative methods have become integral in health services research, and Andersen’s behavioural model of health services use (BMHSU) is one of the most commonly employed models of health service utilisation. The model focuses on three core factors to explain healthcare utilisation: predisposing, enabling and need factors. A recent overview of the application of the BMHSU is lacking, particularly regarding its application in qualitative research. Therefore, we provide (1) a descriptive overview of the application of the BMHSU in health services research in general and (2) a qualitative synthesis on the (un)suitability of the model in qualitative health services research.

METHODS: We searched five databases from March to April 2019, and in April 2020. For inclusion, each study had to focus on individuals ≥18 years of age and to cite the BMHSU, a modified version of the model, or the three core factors that constitute the model, regardless of study design, or publication type. We used MS Excel to perform descriptive statistics, and applied MAXQDA 2020 as part of a qualitative content analysis.

RESULTS: From a total of 6319 results, we identified 1879 publications dealing with the BMSHU. The main methodological approach was quantitative (89%). More than half of the studies are based on the BMHSU from 1995. 77 studies employed a qualitative design, the BMHSU was applied to justify the theoretical background (62%), structure the data collection (40%) and perform data coding (78%). Various publications highlight the usefulness of the BMHSU for qualitative data, while others criticise the model for several reasons (eg, its lack of cultural or psychosocial factors).

CONCLUSIONS: The application of different and older models of healthcare utilisation hinders comparative health services research. Future research should consider quantitative or qualitative study designs and account for the most current and comprehensive model of the BMHSU.

PMID:33952550 | DOI:10.1136/bmjopen-2020-045018

BMJ Open. 2021 May 5;11(5):e047386. doi: 10.1136/bmjopen-2020-047386.

ABSTRACT

OBJECTIVES: To trial a simplified, time and cost-saving method for remote evaluation of fellowship applications and compare this with existing panel review processes by analysing concordance between funding decisions, and the use of a lottery-based decision method for proposals of similar quality.

DESIGN: The study involved 134 junior fellowship proposals for postdoctoral research (‘Postdoc.Mobility’). The official method used two panel reviewers who independently scored the application, followed by triage and discussion of selected applications in a panel. Very competitive/uncompetitive proposals were directly funded/rejected without discussion. The simplified procedure used the scores of the two panel members, with or without the score of an additional, third expert. Both methods could further use a lottery to decide on applications of similar quality close to the funding threshold. The same funding rate was applied, and the agreement between the two methods analysed.

SETTING: Swiss National Science Foundation (SNSF).

PARTICIPANTS: Postdoc.Mobility panel reviewers and additional expert reviewers.

PRIMARY OUTCOME MEASURE: Per cent agreement between the simplified and official evaluation method with 95% CIs.

RESULTS: The simplified procedure based on three reviews agreed in 80.6% (95% CI: 73.9% to 87.3%) of applicants with the official funding outcome. The agreement was 86.6% (95% CI: 80.6% to 91.8%) when using the two reviews of the panel members. The agreement between the two methods was lower for the group of applications discussed in the panel (64.2% and 73.1%, respectively), and higher for directly funded/rejected applications (range: 96.7%-100%). The lottery was used in 8 (6.0%) of 134 applications (official method), 19 (14.2%) applications (simplified, three reviewers) and 23 (17.2%) applications (simplified, two reviewers). With the simplified procedure, evaluation costs could have been halved and 31 hours of meeting time saved for the two 2019 calls.

CONCLUSION: Agreement between the two methods was high. The simplified procedure could represent a viable evaluation method for the Postdoc.Mobility early career instrument at the SNSF.

PMID:33952554 | DOI:10.1136/bmjopen-2020-047386

BMJ Open. 2021 May 5;11(5):e044374. doi: 10.1136/bmjopen-2020-044374.

ABSTRACT

INTRODUCTION: Self-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The ‘SM model for patients on VAD support’ will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum.

METHODS AND ANALYSIS: This is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3.

ETHICS AND DISSEMINATION: Ethical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English.

TRIAL REGISTRATION NUMBERS: NCT04234230 and NCT04526964; Pre-results.

PMID:33952544 | DOI:10.1136/bmjopen-2020-044374

BMJ Open. 2021 May 5;11(5):e044815. doi: 10.1136/bmjopen-2020-044815.

ABSTRACT

OBJECTIVES: To identify psychosocial determinants of quit motivation in older deprived smokers. The evidence may be used to optimise smoking cessation interventions for the target population.

DESIGN: Cross-sectional survey using online recruitment methods including Facebook-targeted advertising.

SETTING: UK, 2019.

PARTICIPANTS: Current smokers aged 50 years or older and from a socioeconomically deprived background.

MAIN OUTCOME MEASURES: Measures included motivation to stop smoking, smoking history, perceived social support, self-efficacy for quitting, self-exempting beliefs and lung cancer risk perception. Multivariable regression was used to analyse factors associated with quit motivation.

RESULTS: Of a total 578 individuals who consented to take part, 278 (48.1%) did not meet the inclusion criteria. Of the 300 eligible participants, most were recruited using Facebook (94.0%), were aged 50-64 years (83.7%) and women (85.7%). Most participants were renting from a housing association (72.0%) and had low education (61.0%). Higher motivation to quit was statistically significantly associated with a higher intensity of previous quit attempts (p=0.03), higher quit confidence (p=0.01), higher smoking self-efficacy (p=0.01), a lower risk-minimising beliefs score (p=0.01) and using traditional nicotine replacement therapy (NRT) when trying to stop smoking or cut down (p<0.001).

CONCLUSION: Older smokers from deprived backgrounds face complex barriers to quitting smoking. Interventions are needed to increase self-efficacy for quitting, modify risk-minimising beliefs and target elements of previous quit attempts (ie, the use of NRT) that are associated with motivation to stop smoking.

PMID:33952547 | DOI:10.1136/bmjopen-2020-044815