Preterm birth and prescriptions for cardiovascular, antiseizure, antibiotics and antiasthmatic medication in children up to 10 years of age: a population-based data linkage cohort study across six European regions

Objectives
Preterm children are exposed to many medications in neonatal intensive care units, but little is known about the effect of prematurity on medication use throughout infancy and childhood. We examined prescriptions of cardiovascular medication (CVM), antiseizure medication (ASM), antiasthmatic medication and antibiotics issued/dispensed in the first 10 years of life for very and moderately preterm children compared with term.

Design
Population-based data linkage cohort study linking information from birth records to prescription records.

Setting
Six registries from five countries in the EUROlinkCAT study.

Participants
The study population included 1 722 912 children, of whom 10 820 (0.6%) were very preterm (

Leggi
Ottobre 2022

Association between the interval of worksite dental check-ups and dental and medical expenditures: a single-site, 12-year follow-up study in Japan

Objectives
The purpose of this study was to identify the effective intervals of worksite dental check-ups to reduce cumulative dental expenditures (CDEs) and cumulative medical expenditures (CMEs), based on 12 years of follow-up dental check-ups.

Setting, design and participants
A longitudinal study was conducted between 2002 and 2014 fiscal years. A total of 2691 full-time employees (2099 males and 592 females) aged 20–59 years in a manufacturing company in Japan were recruited.

Primary and secondary outcome measures
Based on the follow-up of 12-year dental check-ups, the interval of dental check-ups visits was classified into the following categories: ‘Once per year’ as the regular group, ‘At least once per 2 years’ as the subregular group and others as the irregular group. CDEs and CMEs per capita were examined by the three groups of dental check-ups interval after adjustment for sex, age, occupation and total CMEs at baseline. For sensitivity analysis, decayed teeth, missing teeth and Community Periodontal Index were added as adjustment factors.

Results
Compared with the irregular group, the pooled CDEs (including dental check-ups fee) per capita in the subregular group (OR 0.91, 95% CI 0.85 to 0.98) and regular group (OR 0.87, 95% CI 0.81 to 0.93) were significantly lower overall. The younger adults in the subregular group and younger-aged and middle-aged adults in the regular group had significantly lower CDEs. Sensitivity analysis confirmed these findings.

Conclusions
Our findings suggest that regular and subregular worksite dental check-ups were related to reduction of CDEs. It is important to promote a yearly interval between dental check-ups.

Leggi
Ottobre 2022

Spatial Relation Between White Matter Hyperintensities and Incident Lacunes of Presumed Vascular Origin: A 14-Year Follow-Up Study

Stroke, Ahead of Print. BACKGROUND:The underlying mechanisms of incident lacunes regarding their spatial distribution remain largely unknown. We investigated the spatial distribution pattern and MRI predictors of incident lacunes in relation to white matter hyperintensity (WMH) over 14 years follow-up in sporadic small vessel disease.METHODS:Five hundred three participants from the ongoing prospective single-center Radboud University Nijmegen Diffusion Tensor and Magnetic resonance Cohort (RUN DMC) were recruited with baseline assessment in 2006 and follow ups in 2011, 2015, and 2020. Three hundred eighty-two participants who underwent at least 2 available brain MRI scans were included. Incident lacunes were systematically identified, and the spatial relationship between incident lacunes located in subcortical white matter and WMH were determined using a visual rating scale. Adjusted multiple logistic regression and linear mixed-effect regression models were used to assess the association between baseline small vessel disease markers, WMH progression, and incident lacunes. Participants with atrial fibrillation were excluded in multivariable analysis.RESULTS:Eighty incident lacunes were identified in 43 patients (mean age 66.5±8.2 years, 37.2% women) during a mean follow-up time of 11.2±3.3 years (incidence rate 10.0/1000 person-year). Sixty percent of incident lacunes were in the white matter, of which 48.9% showed no contact with preexisting WMH. Baseline WMH volume (odds ratio=2.5 [95% CI, 1.6–4.2]) predicted incident lacunes after adjustment for age, sex, and vascular risk factors. WMH progression was associated with incident lacunes independent of age, sex, baseline WMH volume, and vascular risk factors (odds ratio, 3.2 [95% CI, 1.5–6.9]). Baseline WMH volume and progression rate were higher in participants with incident lacunes in contact with preexisting WMH. No difference in vascular risk factors was observed regarding location or relation with preexisting WMH.CONCLUSIONS:The 2 different distribution patterns of lacunes regarding their relation to WMH may suggest distinct underlying mechanisms, one of which may be more closely linked to a similar pathophysiology as that of WMH. The longitudinal relation between WMH and lacunes further supports plausible shared mechanisms between the 2 key markers.

Leggi
Ottobre 2022

Developing and validating a risk prediction model for preterm birth at Felege Hiwot Comprehensive Specialized Hospital, North-West Ethiopia: a retrospective follow-up study

Objective
To develop and validate a risk prediction model for the prediction of preterm birth using maternal characteristics.

Design
This was a retrospective follow-up study. Data were coded and entered into EpiData, V.3.02, and were analysed using R statistical programming language V.4.0.4 for further processing and analysis. Bivariable logistic regression was used to identify the relationship between each predictor and preterm birth. Variables with p≤0.25 from the bivariable analysis were entered into a backward stepwise multivariable logistic regression model, and significant variables (p

Leggi
Settembre 2022

Are better existing WASH practices in urban slums associated with a lower long-term risk of severe cholera? A prospective cohort study with 4 years of follow-up in Mirpur, Bangladesh

Objective
To investigate the association between existing household water quality, sanitation and hygiene (WASH) practices and severe cholera risk in a dense urban slum where cholera is highly endemic.

Design, setting and participants
We assembled a large prospective cohort within a cluster randomised trial evaluating the effectiveness of oral cholera vaccine. Our dynamic cohort population (n=193 576) comprised individuals living in the ‘non-intervention’ clusters of the trial, and were followed over 4 years. This study was conducted in a dense urban slum community of Dhaka, Bangladesh and cholera surveillance was undertaken in 12 hospitals serving the study area.

Primary outcome measure
First severe cholera episode detected during follow-up period.

Methods
We applied a machine learning algorithm on a training subpopulation (n=96 943) to develop a binary (‘better’, ‘not better’) composite WASH variable predictive of severe cholera. The WASH rule was evaluated for performance in a separate validation subpopulation (n=96 633). Afterwards, we used Cox regression models to evaluate the association between ‘better’ WASH households and severe cholera risk over 4 years in the entire study population.

Results
The ‘better’ WASH rule found that water quality and access were the most significant factors associated with severe cholera risk. Members of ‘better’ WASH households, constituting one-third of the population, had a 47% reduced risk of severe cholera (95% CI: 29 to 69; p

Leggi
Settembre 2022

Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial)

Introduction
Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation.

Methods and analysis
In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors.

Ethics and dissemination
The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences.

Trial registration number
NCT04795843.

Leggi
Settembre 2022

Prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers in Belgium: a prospective cohort study with 12 months of follow-up

Objectives
To estimate the prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers (PHCPs).

Design
Prospective cohort study with 12 months of follow-up.

Setting
Primary care in Belgium.

Participants
Any general practitioner (GP) working in primary care in Belgium and any other PHCP from the same GP practice who physically manages (examines, tests, treats) patients were eligible. A convenience sample of 3648 eligible PHCPs from 2001 GP practices registered for this study (3044 and 604 to start in December 2020 and January 2021, respectively). 3390 PHCPs (92,9%) participated in their first testing time point (2820 and 565, respectively) and 2557 PHCPs (70,1%) in the last testing time point (December 2021).

Interventions
Participants were asked to perform a rapid serological test targeting IgM and IgG against the receptor binding domain of SARS-CoV-2 and to complete an online questionnaire at each of maximum eight testing time points.

Primary and secondary outcome measures
The prevalence, incidence and longevity of antibodies against SARS-CoV-2 both after natural infection and after vaccination.

Results
Among all participants, 67% were women and 77% GPs. Median age was 43 years. The seroprevalence in December 2020 (before vaccination availability) was 15.1% (95% CI 13.5% to 16.6%), increased to 84.2% (95% CI 82.9% to 85.5%) in March 2021 (after vaccination availability) and reached 93.9% (95% CI 92.9% to 94.9%) in December 2021 (during booster vaccination availability and fourth (delta variant dominant) COVID-19 wave). Among not (yet) vaccinated participants the first monthly incidence of antibodies against SARS-CoV-2 was estimated to be 2.91% (95% CI 1.80% to 4.01%). The longevity of antibodies is higher in PHCPs with self-reported COVID-19 infection.

Conclusions
This study confirms that occupational health measures provided sufficient protection when managing patients. High uptake of vaccination resulted in high seroprevalence of SARS-CoV-2 antibodies in PHCPs in Belgium. Longevity of antibodies was supported by booster vaccination and virus circulation.

Trial registration number
NCT04779424.

Leggi
Settembre 2022

Determining the Endoscopic Follow-Up for Gastric Ulcers Based Upon Endoscopic Appearance and Histology (Poster Presentation)

Gastric ulcers are common, but the prevalence rate of malignancy in endoscopically diagnosed gastric ulcers varies considerably. It is unclear whether endoscopic follow-up is warranted in all patients with gastric ulcers, as the yield of the follow-up endoscopy is very low, especially in the setting when histology shows benign features. We performed a quality improvement project to determine the diagnostic accuracy of combined endoscopic and histologic features in differentiating benign from malignant gastric ulcers vs endoscopic features only and to avoid over-use of endoscopic evaluation of ulcer healing for benign cases.

Leggi
Settembre 2022

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-up Outcomes of Multicenter Randomized Controlled BEST Trial

Circulation, Ahead of Print. Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stent and coronary-artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease.Methods: This prospective, multicenter, randomized, controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stent or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early due to slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target-vessel revascularization.Results: During a median follow-up of 11.8 years (interquartile range, 10.6 to 12.5 years, maximum 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR] 1.18; 95% confidence interval [CI], 0.88 to 1.56; P=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%, HR 1.07; 95% CI 0.75 to 1.53; P=0.70) as well as the occurrence of death from any cause (20.5% and 19.9%, HR 1.04; 95% CI 0.65 to 1.67; P=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%, HR 1.86; 95% CI 1.06 to 3.27; P=0.031) and any repeat revascularization (22.6% and 12.7%, HR 1.92; 95% CI 1.58 to 2.32; P

Leggi
Settembre 2022

Short-term outcomes and intermediate-term follow-up of Helicobacter pylori infection treatment for naïve patients: a retrospective observational study

Objectives
To explore the outcomes of Helicobacter pylori infection treatments for naïve patients in the real-world settings.

Design
A retrospective observational study.

Setting
Single tertiary level academic hospital in China.

Participants
We identified patients initially receiving quadruple therapy for H. pylori infection from 2017 to 2020 in whom eradication was confirmed (n=23 470).

Primary outcome
Efficacy of different initial H. pylori infection treatments.

Secondary outcome
Results of urea breath test (UBT) after H. pylori eradication.

Results
Among 23 470 patients who received initial H. pylori treatment, 21 285 (90.7%) were treated with amoxicillin-based regimens. The median age of the patients decreased from 2017 to 2020 (45.0 vs 39.0, p

Leggi
Settembre 2022

Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial)

Introduction
The standard surgical treatment for recurrent or chronic tonsillitis is extracapsular tonsillectomy. Recent studies show that intracapsular tonsillectomy has the potential to reduce the postoperative morbidity of patients undergoing tonsil surgery. The Finnish Intracapsular Tonsillectomy (FINITE) trial aims to provide level I evidence to support the hypothesis that the recovery time from tonsil surgery can be reduced with intracapsular tonsillectomy. Additionally, from this trial, major benefits in quality of life, reduction of postoperative complications, treatment costs and throat symptoms might be gained.

Methods and analysis
The FINITE trial is a prospective, randomised, controlled, patient-blinded, three-arm clinical trial. It is designed to compare three different surgical methods being extracapsular monopolar tonsillectomy versus intracapsular microdebrider tonsillectomy versus intracapsular coblation tonsillectomy in the treatment of adult patients (16–65 years) suffering from recurrent or chronic tonsillitis. The study started in September 2019, and patients will be enrolled until a maximum of 200 patients are randomised. Currently, we are in the middle of the study with 125 patients enrolled as of 28 February 2022 and data collection is scheduled to be completed totally by December 2027. The primary endpoint of the study will be the recovery time from surgery. Secondary endpoints will be the postoperative pain scores and the use of analgesics during the first 3 weeks of recovery, postoperative haemorrhage, quality of life, tonsillar remnants, need for revision surgery, throat symptoms, treatment costs and sick leave. A follow-up by a questionnaire at 1–21 days and at 1, 6, 24 and 60 months will be conducted with a follow-up visit at the 6-month time point.

Ethics and dissemination
Ethical approval was obtained from the Medical Ethics Committee of the Hospital District of Southwest Finland (reference number 29/1801/2019). Results will be made publicly available in peer-reviewed scientific journals.

Trial registration number
NCT03654742.

Leggi
Settembre 2022

Diagnostic work-up of urinary tract infections in pregnancy: study protocol of a prospective cohort study

Introduction
Symptoms of urinary tract infections in pregnant women are often less specific, in contrast to non-pregnant women where typical clinical symptoms of a urinary tract infection are sufficient to diagnose urinary tract infections. Moreover, symptoms of a urinary tract infection can mimic pregnancy-related symptoms, or symptoms of a threatened preterm birth, such as contractions. In order to diagnose or rule out a urinary tract infection, additional diagnostic testing is required.
The diagnostic accuracy of urine dipstick analysis and urine sediment in the diagnosis of urinary tract infections in pregnant women has not been ascertained nor validated.

Methods and analysis
In this single-centre prospective cohort study, pregnant women (≥16 years old) with a suspected urinary tract infection will be included. The women will be asked to complete a short questionnaire regarding complaints, risk factors for urinary tract infections and baseline characteristics. Their urine will be tested with a urine dipstick, urine sediment and urine culture. The different sensitivities and specificities per test will be assessed. Our aim is to evaluate and compare the diagnostic accuracy of urine dipstick analysis and urine sediment in comparison with urine culture (reference test) in pregnant women. In addition, we will compare these tests to a predefined ‘true urinary tract infection’, to distinguish between a urinary tract infection and asymptomatic bacteriuria.

Ethics and dissemination
Approval was requested from the Medical Ethics Review Committee of the Academic Medical Centre; an official approval of this study by the committee was not required. The outcomes of this study will be published in a peer-reviewed journal.

Leggi
Settembre 2022