Search Results for: Follow-up dopo colonscopia e polipectomia

Objectives
This study aimed to develop risk prediction equations for the 5-year incidence of diabetes among the Japanese population using health check-up data. We hypothesised that demographic and laboratory data from health check-ups could predict diabetes onset with high accuracy.

Design
Retrospective cohort study.

Setting
Data from a health examination in Japan between 2008 and 2016.

Participants
Data were analysed from 31 084 participants aged 30–69 years. The presence of baseline diabetes and endocrine disease was included in the exclusion criteria, as were participants with missing data for the analysis. The study population was randomly divided into derivation and validation cohorts in a 1:1 ratio.

Primary outcome measures
The primary outcome was the incidence of diabetes at the 5-year follow-up, defined as a fasting blood glucose level ≥126 mg/dL, glycosylated haemoglobin A1c (National Glycohemoglobin Standardization Program (NGSP)) ≥6.5%, or initiation of diabetes treatment. Predictor variables included age, sex, body mass index, blood pressure, underlying diseases, lifestyle factors and laboratory measurements. The primary measure was the area under the receiver operating characteristic curve (AUC) for the predictive equations.

Results
In the derivation cohort, diabetes incidence was 5.0%. The prediction equation incorporating age, sex, body mass index, fasting blood glucose and glycosylated haemoglobin A1c showed good discriminatory ability with an AUC of 0.89, sensitivity of 0.81 and specificity of 0.81 in the validation cohort.

Conclusions
The equation with laboratory measures effectively predicted the 5-year diabetes risk in the general Japanese population. It has potential clinical utility for identifying individuals at high risk of diabetes and guiding preventive interventions.

To the Editor A recent trial reported that camrelizumab in combination with chemotherapy significantly improved the pathological complete response (pCR) compared with placebo in combination with chemotherapy among patients with early or locally advanced triple-negative breast cancer (TNBC), with pCR rates of 56.8% vs 44.7%, respectively. However, the 18-month event-free survival rates were 86.6% vs 83.6% (hazard ratio, 0.80 [95% CI, 0.46-1.42]), showing no statistical significance, and the wide CI indicates that the study had a relatively short follow-up period and immature survival data.

Viruses are a major cause of central nervous system (CNS) infections in pediatric patients, often resulting in significant rates of morbidity and mortality. Many viruses have been implicated in neurodevelopmental disorders with long-term consequences that significantly impact families, healthcare systems, economies, and society. Unfortunately, however, long-term follow-up studies evaluating neurodevelopmental outcomes in pediatric survivors of viruses affecting the nervous system are limited. The disease burden of CNS infection is often highest in regions where resources are lowest, such as in low- and middle-income countries (LMICs).

Objectives
The aim of this study was to explore physicians’ experiences of the process leading up to their sick leave due to exhaustion disorder (ED).

Design
A qualitative study with a narrative approach was conducted.

Setting
The study was conducted in Sweden. Interviews with physicians were conducted face-to-face during the Spring and Autumn of 2022. Each interview lasted between 35 and 60 min.

Participants
Purposive sampling was employed to recruit physicians on long-term sick leave for ED. We used an interview guide with open-ended questions.

Results
12 physicians shared their experiences of the process leading to their ED-related sick leave. Four themes related to different phases of the process: Theme 1. Strongly motivated to become a physician, Theme 2. Demands delivering best practice, Theme 3. Symptoms of ill health and Theme 4. Managing symptoms of ED. The narrative analyses showed a holistic understanding of the personal consequences for the physicians and their families as well as the consequences in working life.

Conclusions
Politicians and leaders at different healthcare levels must take responsibility for strengthening the working environment, which is important for creating long-term and sustainable healthcare services.

Introduction
Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

Methods and analysis
The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

Ethics and dissemination
The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Trial registration number
Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

Background
Aortic valve stenosis (AVS) represents the most prevalent primary valvular lesion necessitating surgical intervention or transcatheter intervention in Europe and North America. Its prevalence is increasing at a rapid rate as a consequence of the ageing population. A variety of mechanical interventions are available to determine the management of AVS; however, there is currently a paucity of robust data with which to perform a comparative analysis of the efficacy of surgical aortic valve replacement (SAVR) and that of conventional stented xenograft bioprostheses (BP) or sutureless aortic valves (SAV) and transcatheter aortic valve implantation (TAVI). The present study aims to compare the effectiveness and clinical outcomes of SAVR using BP or SAV technique and TAVI in patients with severe AVS.

Methods and analysis
A collaboration between three cardiac surgery centres across two European countries has resulted in the conception of the Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement trial. This prospective non-randomised trial is designed to evaluate the long-term outcomes of TAVI in comparison to SAVR for AVS in patients at risk of severe valve obstruction. The registry will enrol successive patients who have undergone mechanical intervention for AVS between January 2015 and December 2025. Investigators will assess the difference between replacement procedures for both the standard surgical approach and the transcatheter procedure. The principal clinical outcome under consideration will be the composite degree of all-cause mortality, ischaemic stroke or rehospitalisation at 10 years. The present study will also have a number of secondary endpoints, including all-cause mortality, followed by functional status, hospitalisation, neurocognition, physiological measures (echocardiographic assessment), adverse events and reoperation.

Ethics and dissemination
It is hypothesised that the nature of the trials will serve to minimise bias related to institutional volume and surgical experience. Each participating centre is required to have an aortic valve programme that enables proper follow-up and management of any late aortic events following replacement surgery for the AVS. The data collected will provide valuable insight into the comparative effectiveness of various surgical approaches, both standardised and advanced, in aortic valve surgery and TAVI. This comprehensive analysis will contribute significantly to the development of robust international guidelines.

Trial registration number
Clinical Trial Gov.Com. ID: NCT05261204 IRB. ID: 2022011057

Introduction
Despite being a leading cause of female morbidity and mortality, female-specific cardiovascular disease (CVD) is understudied, underdiagnosed and undertreated. Pregnancy complications involving the placenta, including pre-eclampsia, pregnancy-induced hypertension and foetal growth restriction, are thought to reflect global maternal vascular derangements that indicate a twofold to eightfold increased risk of future CVD. This calls for a better understanding of female cardiovascular pathophysiology to allow development of targeted screening and prevention strategies.
Acute atherosis is a placental vascular lesion, which histologically resembles systemic atherosclerosis. The PlacEntal Acute atherosis RefLecting Subclinical atherosclerosis study investigates the association between placental acute atherosis lesions and subclinical systemic atherosclerosis up to 20 years postpartum.
This study will improve our understanding of the relationship between pregnancy complications and CVD to identify potential prevention targets and treatments. In addition, it could determine whether the placenta can improve identification of young women at high risk of CVD. These women could benefit from risk-reducing interventions.

Methods and analysis
This longitudinal prospective cohort study will include women who are either currently pregnant or from a historical cohort. Both groups will have placental histopathology and a single postpartum CVD assessment. The CVD assessment will include medical history taking, blood tests, electrocardiography and echocardiography. Additionally, coronary CT angiography focusing on the presence of atherosclerotic plaques and calcium score will be carried out.
The currently pregnant women will either have a pre-eclamptic pregnancy (pre-eclamptic group) or an uncomplicated normotensive pregnancy (uncomplicated group), and their placenta will be collected prospectively. The single CVD assessment will be carried out 6–36 months postpartum.
Women from the historical cohort had a pre-eclamptic pregnancy 10–20 years ago. Placental tissue is available for reanalysis. The single CVD assessment will take place immediately and corresponds with 10–20 years postpartum.
Exclusion criteria are contraindications to diagnostic assessment necessities: iodinated contrast, beta-blockers or glyceryl trinitrate. Women with uncomplicated pregnancies will be excluded if they have a pre-existing auto-immune condition, chronic hypertension or diabetes mellitus. In the pre-eclamptic group, there are no additional exclusion criteria.

Ethics and dissemination
Ethical approval was granted by the Medical Ethics Committee in Maastricht University Medical Centre+ (NL52556.068.15/METC152019). Participants will give written informed consent. Results will be shared in peer-reviewed journals and conference presentations.

Trial registration number
NCT05500989; ClinicalTrials.gov Identifier.

Purpose
The AMBulatoRy blOod preSsure In older Adults (AMBROSIA) study cohort was designed to determine whether ambulatory blood pressure (BP) monitoring (ABPM) is useful for identifying older adults with hypertension taking antihypertensive medication who are at increased risk for falls. The association of home BP monitoring (HBPM) with falls was assessed in an ancillary study (AMBROSIA-HOME).

Participants
AMBROSIA was a prospective observational study of adults aged 65 years and older taking antihypertensive medication for hypertension. Participants were recruited from Kaiser Permanente Southern California (KPSC), an integrated healthcare delivery system, and enrolled from May 2019 to November 2022. Demographic and clinical characteristics and geriatric assessments were collected over the course of two consecutive study visits. Participants completed a 24-hour ABPM and 1 week of HBPM. Over the following year, falls were assessed using a monthly falls calendar, and serious fall injuries were assessed from the KPSC electronic health record (EHR).

Findings to date
We enrolled 670 participants; 656 completed 24-hour ABPM and 536 also completed HBPM. The mean (SD) age of the AMBROSIA cohort was 75 (6) years, 16% were over 80 years of age and 56% were female. There were 13% non-Hispanic Asian or Pacific Islander, 22% non-Hispanic Black, 18% Hispanic and 44% non-Hispanic White participants. Nearly 72% had mild cognitive impairment, 50% were pre-frail and 4% were frail. Overall, 87% of participants returned all monthly calendars during follow-up.

Future plans
The AMBROSIA cohort can be updated with longitudinal data from the EHR including antihypertensive medication to explore the relationship of fall risk and white coat effect, defined as the difference between clinic BP and out-of-clinic BP, BP variability over 24 hours and postprandial BP decline with antihypertensive medication intensification during follow-up. Additionally, the cohort can be updated to include outcomes data from the EHR such as cardiovascular events to examine BP phenotypes as potential predictors of cardiovascular events.

Introduction
Physical activity (PA) is crucial for older adults’ well-being and mitigating health risks. Encouraging active lifestyles requires a deeper understanding of the factors influencing PA, which conventional approaches often overlook by assuming stability in these determinants over time. However, individual-level determinants fluctuate over time in real-world settings. Digital phenotyping (DP), employing data from personal digital devices, enables continuous, real-time quantification of behaviour in natural settings. This approach offers ecological and dynamic assessments into factors shaping individual PA patterns within their real-world context. This paper presents a study protocol for the DP of PA behaviour among community-dwelling older adults aged 65 years and above.

Methods and analysis
This 2-week multidimensional assessment combines supervised (self-reported questionnaires, clinical assessments) and unsupervised methods (continuous wearable monitoring and ecological momentary assessment (EMA)). Participants will wear a Garmin Vivosmart V.5 watch, capturing 24/7 data on PA intensity, step count and heart rate. EMA will deliver randomised prompts four times a day via the Smartphone Ecological Momentary Assessment3 application, collecting real-time self-reports on physical and mental health, motivation, efficacy and contextual factors. All measurements align with the Behaviour Change Wheel framework, assessing capability, opportunity and motivation. Machine learning will analyse data, employing unsupervised learning (eg, hierarchical clustering) to identify PA behaviour patterns and supervised learning (eg, recurrent neural networks) to predict behavioural influences. Temporal patterns in PA and EMA responses will be explored for intraday and interday variability, with follow-up durations optimised through random sliding window analysis, with statistical significance evaluated in RStudio at a threshold of 0.05.

Ethics and dissemination
The study has been approved by the ethical committee of Hasselt University (B1152023000011). The findings will be presented at scientific conferences and published in a peer-reviewed journal.

Trial registration number
NCT06094374.

All evaluable patients met the continuation criteria. Clinical and radiological data suggest deceleration of disease progression compared with available natural history data, indicating that leriglitazone may be beneficial in boys with cerebral adrenoleukodystrophy. Additional follow-up will fully assess the safety and efficacy of leriglitazone in cerebral adrenoleukodystrophy.

Introduction
Current clinical practice in bariatric surgery follow-up care is highly heterogeneous, and patients have reported needing more and extended personalised support. Especially, they want more support on how to self-manage and cope with the changes and challenges of living with the chronic aspects of obesity and a changing body following surgery. The overall aim of this study protocol is to develop and validate a digital self-management support checklist in bariatric surgery aftercare.

Methods
We propose a protocol for a modified, electronic Delphi study design using qualitative and quantitative methods to develop and validate the content of the checklist. The study is divided into two phases: (1) generation of candidate checklist attributes and (2) validation of candidate checklist attributes. In Phase 1, two qualitative studies involving individual interviews with patients and focus groups with healthcare professionals will be conducted to derive context-specific knowledge. This knowledge will be combined with best-practice evidence and stakeholder input to generate candidate checklist attributes, that is, principles, items and features. In Phase 2, a two-round electronic Delphi survey with an expert panel will be conducted to assess the relevance, comprehensibility and comprehensiveness of candidate checklist attributes and to determine the final checklist attributes based on content validity results from the Delphi process. Reflexive thematic analysis will be used on qualitative data and descriptive statistics on quantitative data.

Ethics and dissemination
The study has been approved by the Regional Committee for Medical and Health Research Ethics, Region West (2023/676367). The Data Protection Officer at Førde Hospital Trust and collaborating hospital trusts have approved the project (4386–4386). The results will be presented at scientific conferences, published and open-accessed in international peer-reviewed journals.

Objective
To examine the feasibility, safety and perceived patient response of a combined repetitive transcranial magnetic stimulation (rTMS) and quadriceps strengthening exercise intervention for knee osteoarthritis.

Methods
A two-arm, participant-blinded, therapist-blinded and assessor-blinded, randomised controlled trial with additional follow-up of pain and function at 3 months. Participants were randomised to receive active rTMS+exercise (AR+EX) or sham rTMS+exercise (SR+EX) twice weekly for 6 weeks while completing home exercises twice a week. Primary outcomes included recruitment rate, treatment attendance, dropouts, willingness to undergo therapy (11-point Numeric Rating Scale, ‘not at all willing’=0 and ‘very willing’=10), success of participant, therapist and outcome assessor blinding, adverse events and Global Perceived Effect Scale. Secondary outcomes were pain, function and measures of physiological mechanisms.

Results
86 people were screened, 31 (36%) were randomised, 28 (90%) completed the treatments and 3 (10%) dropouts at 3-month follow-up. Both groups had high treatment attendance (98.4% and 100%). All participants scored at least 7 on the willingness to undergo therapy scale. Blinding was successful. No adverse events were reported. At the postintervention assessment, 80% in the AR+EX group and 75% in the SR+EX group reported an improvement on the Global Perceived Effect Scale. Both groups demonstrated within-group improvements in pain at the postintervention assessment but not at the 3-month follow-up. Function improved only in the AR+EX group at the postintervention assessment.

Conclusions
Combined rTMS and quadriceps strengthening exercise intervention for knee osteoarthritis is feasible, safe and well-received. A full-scale trial is justified to assess the clinical benefits of this novel treatment.

Trial registration number
ACTRN12621001712897.

Introduction
Healthy dietary choices have an important role in preventing chronic diseases such as cardiovascular disease (CVD). Increasing evidence suggests micronutrient intake (essential minerals and vitamins) is associated with abdominal aortic calcification (AAC), which is an advanced marker of CVD. However, the existing reports seem inconsistent. Some studies reported micronutrients are associated with a lower risk of AAC, while others have reported an increased risk. Therefore, this systematic review and meta-analysis sought to summarise the available evidence on the association of dietary micronutrient intake on AAC.

Methods and analysis
A comprehensive systematic search of the PubMed/MEDLINE, EMBASE, Web of Science and Google Scholar databases from their inception up to September 1, 2024, will be conducted. All clinical studies that report eligible exposure/s (dietary micronutrient intake) and outcome/s (presence/severity of AAC) will be included, and this systematic review and meta-analysis protocol will be reported following the revised Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. The risk of bias for observational studies will be assessed using the Newcastle-Ottawa Scale and publication bias will be evaluated through visual inspection of funnel plots and the Egger’s and Begg’s regression tests. The Der Simonian and Laird random-effects model meta-analysis will be calculated to provide pooled results, and the weighted risk ratio with their 95% confidence intervals will be presented.

Ethics and dissemination
The results will be disseminated through publishing in a peer-reviewed journal and public presentations at relevant local, national and international conferences, workshops and symposiums. Ethical approval is not required as this is a systematic review of publicly available data.
PROSPERO registration number
CRD42024575902

Introduction
Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy

Background
Extrapulmonary tuberculosis (EPTB) is a significant public health issue in Indonesia, a country with a high tuberculosis burden. EPTB accounts for 15%–20% of global TB cases, with the proportion rising in populations co-infected with HIV. In Indonesia, estimates of EPTB prevalence vary significantly due to inconsistencies in diagnostic criteria, population demographics and methodologies. These variations highlight the need for a systematic review to synthesise existing evidence and provide a comprehensive understanding of EPTB’s epidemiology in Indonesia. This study aims to consolidate findings from various studies to identify prevalence trends, inform public health strategies and address knowledge gaps in diagnosing and managing EPTB.

Methods
This systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines and has been registered with PROSPERO (Registration Number: CRD42024601175). A comprehensive search will be conducted in databases including PubMed, Google Scholar, ScienceDirect, Scopus and Southeast Asian Index Medicus to identify studies published between 2005 and 2024. Inclusion criteria include observational studies reporting EPTB prevalence in Indonesia based on clinical, microbiological or radiological diagnoses. Two independent reviewers will conduct study selection, data extraction and quality assessments using the Newcastle-Ottawa Scale. Data will be analysed using a random-effects model to estimate pooled prevalence, and subgroup analyses will explore variability by region, age and clinical setting. The study selection process will be documented using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram, and potential publication bias will be evaluated with funnel plots and the trim-and-fill method.

Ethics and dissemination
As this review involves secondary analysis of published data, no ethical approval is required. Findings will be disseminated through peer-reviewed journal publications and conference presentations.

Stroke, Ahead of Print. BACKGROUND:This study aimed to investigate neurophysiological mechanisms underlying functional impairment and recovery after acute ischemic stroke using transcranial magnetic stimulation combined with electroencephalography, focusing on interhemispheric interactions and oscillatory dynamics.METHODS:This single-center case-control study (December 2022 to May 2024) included 19 ischemic stroke patients within 14 days of symptom onset (mean age, 47.95±12.41 years; 15 [79%] males) with 3-month poststroke follow-up. Sixteen age-matched healthy controls (53.56±9.83 years; 12 [80%] males) were included. Transcranial magnetic stimulation-evoked electroencephalography potentials, local mean field power during 25 ms and 35 ms (local mean field power25–35 ms), and power spectral density of the ipsilesional primary motor cortex (ilM1) were calculated when single-pulse transcranial magnetic stimulation was sequentially applied to the contralesional M1 (clM1) and ilM1. Spearman correlation analysis evaluated associations between transcranial magnetic stimulation combined with electroencephalography parameters and clinical outcomes: Fugl-Meyer assessment, Fugl-Meyer assessment-upper extremity subscale, National Institutes of Health Stroke Scale, and National Institutes of Health Stroke Scale changes from baseline to 3 months poststroke.RESULTS:Stroke patients exhibited simplified transcranial magnetic stimulation-evoked electroencephalography potential waveforms with reduced amplitudes compared with healthy controls. The contralesional resting motor threshold of stroke patients was significantly lower compared with healthy controls (t=−2.79;P=0.009). The contralesional resting motor threshold was positively associated with the local mean field power25–35 msof ilM1 with stimulation on ilM1 (r=0.482;P=0.018). The power and power spectral density of β oscillations were negatively associated with the Fugl-Meyer assessment (r=−0.557,P=0.014;r=−0.417,P=0.038, respectively) and Fugl-Meyer assessment-upper extremity (r=−0.503,P=0.014;r=−0.389,P=0.05, respectively), but the power of β oscillations was positively associated with changes in the National Institutes of Health Stroke Scale (r=0.507;P=0.027) with stimulation on clM1.CONCLUSIONS:Increased excitability of the clM1 is associated with decreased excitability of the ilM1. The inhibition of β oscillations in the ilM1 by the clM1 serves as a biomarker for poststroke functional impairment and recovery. Neuromodulation of the clM1 to enhance the β oscillations of ilM1 may be a promising treatment strategy.