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Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

San Raffaele Roma, Italia prima al mondo per pazienti coinvolti

Annals of Internal Medicine, Volume 176, Issue 9, Page JC103, September 2023.

Annals of Internal Medicine, Ahead of Print.

Circulation, Ahead of Print. Background:The optimal duration of anticoagulation therapy for isolated distal deep vein thrombosis (DVT) in patients with cancer is clinically relevant, but the evidence is lacking. The prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events, however, it could also increase the risk of bleeding.Methods:In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 60 institutions in Japan, we randomly assigned cancer patients with isolated distal DVT, in a 1-to-1 ratio, to receive either a 12-month or 3-month edoxaban treatment. The primary endpoint was a composite of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death at 12 months. The major secondary endpoint was major bleeding at 12 months, according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that a 12-month edoxaban treatment was superior to a 3-month edoxaban treatment with respect to the primary endpoint.Results:From April 2019 through June 2022, 604 patients were randomized, and after excluding 3 patients who withdrew consent, 601 patients were included in the intention-to-treat population: 296 patients in the 12-month edoxaban group and 305 patients in the 3-month edoxaban group. The mean age was 70.8 years, 28% of the patients were men, and 20% of the patients had symptoms of DVT at baseline. The primary endpoint of a symptomatic recurrent VTE event or VTE-related death occurred in 3 of the 296 patients (1.0%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 0.13; 95% CI, 0.03 to 0.44). The major secondary endpoint of major bleeding occurred in 28 of the 296 patients (9.5%) in the 12-month edoxaban group and in 22 of the 305 (7.2%) in the 3-month edoxaban group (odds ratio, 1.34; 95% CI, 0.75 to 2.41). The prespecified subgroups did not affect the estimates on the primary endpoint.Conclusions:In cancer patients with isolated distal DVT, 12 months was superior to 3 months for an edoxaban treatment with respect to the composite outcome of a symptomatic recurrent VTE or VTE-related death.

Comunicato del 03/08/2023 n°46

Objective
This study aimed at assessing factors associated with first antenatal care (ANC) attendance within 12 weeks of pregnancy among women in Lira City.

Design
A cross-sectional study.

Settings
The study was conducted in health facilities offering ANC services in Lira City, Northern Uganda.

Participants
The study was among 368 pregnant mothers attending their first ANC in the three selected facilities (Lira Regional Referral Hospital, Ober Health Center IV and Pentecostal Assembly of God Mission Health Center IV) in Lira City.

Primary and secondary outcome measures
Level of first ANC attendance within 12 weeks of pregnancy and associated factors.

Results
Early ANC attendance was 36.1%. Women who were: unmarried (adjusted OR (aOR): 0.40, 95% CI: 0.16 to 0.99), took >2 hours to reach a health facility (aOR: 0.21, 95% CI: 0.07 to 0.62), or not visited by village health teams or healthcare workers at home (aOR: 0.33, 95% CI: 0.12 to 0.92) were less likely to attend their first ANC early. On the other hand, women who were: not knowing first that ANC guides parents on infant care (aOR: 2.22, 95% CI: 1.06 to 4.67); pregnant without consent of spouse (aOR: 4.29, 95% CI: 1.75 to 10.55); attending ANC from a private facility (aOR: 2.89, 95% CI: 1.27 to 6.15); and having two to three healthcare workers present at the ANC clinic (aOR: 1.79, 95% CI: 1.03 to 3.13) were more likely to attend ANC early.

Conclusions
Despite the fact that the WHO recommends that all women begin ANC within 12 weeks after conception, Lira City in Northern Uganda had a low overall incidence of timely ANC initiation. Being unmarried, distance to reach a health facility, and being visited by village health teams or healthcare workers at home were all linked to timely ANC commencement. As a result, intervention efforts should concentrate on the highlighted determinants in order to promote ANC initiation in Lira City, Northern Uganda. This can be accomplished by providing information and education to the community on the timing and necessity of ANC in Northern Uganda.

“Figura fondamentale che tutela i diritti”

Introduction
Migraine is a leading cause of disability and suffering worldwide. However, conventional pharmacological migraine preventive therapies are often challenging and accompanied by adverse effects. Recently, structured odour exposure has shown to successfully increase pain thresholds in patients with chronic back pain. Despite the importance of the olfactory system in migraine, there are no studies investigating the impact of structured odour exposure in patients with migraine.

Methods and analysis
This double-blind randomised placebo-controlled trial will be conducted at the Headache Clinic of the University Pain Center at TU Dresden, Germany and aims at investigating the impact of a 12-week structured exposure to odours in women with migraine. Fifty-four women between 18 and 55 years with migraine with aura will be recruited and randomised to training with odours and odourless training. The primary outcomes are mechanical and electrical pain thresholds. Secondary outcomes comprise olfactory threshold and the number of headache days. Other exploratory measurements are headache associated pain intensity, acute analgesic intake, symptoms of anxiety and depression, and quality of life. Additionally, this protocol assesses neuroanatomical and neurofunctional changes associated with the 12-week olfactory training. Data analysis will be executed on the basis of the general linear model considering repeated measurements.

Ethics and dissemination
Ethical approvals were obtained from the Ethics Board of the TU Dresden (Protocol No. BO-EK-353082020). Participation will only be possible after written informed consent is provided. Findings will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number
DRKS00027399.

In questo modo si ottiene la prospettiva della persona che vive la malattia riguardo a una determinata terapia, andando aldilà del dato clinico di sicurezza ed efficacia

Annals of Internal Medicine, Ahead of Print.

Objectives
We aimed to (1) develop a novel instrument, suitable for the general population, capturing intentional non-adherence (iNAR), consisting of non-adherence to prescribed therapy, self-medication and avoidance of seeking medical treatment; (2) differentiate it from other forms of non-adherence, for example, smoking; and (3) relate iNAR to patient-related factors, such as sociodemographics, health status and endorsement of irrational beliefs (conspiratorial thinking and superstitions) and to healthcare-related beliefs and experiences ((mis)trust and negative experiences with the healthcare system, normalisation of patient passivity).

Design
To generate iNAR items, we employed a focus group with medical doctors, supplemented it with a literature search and invited a public health expert to refine it further. We examined the internal structure and predictors of iNAR in an observational study.

Setting
Data were collected online using snowball sampling and social networks.

Participants
After excluding those who failed one or more out of three attention checks, the final sample size was n=583 adult Serbian citizens, 74.4% female, mean age 39.01 years (SD=12.10).

Primary and secondary outcome measures
The primary, planned outcome is the iNAR Questionnaire, while smoking was used for comparison purposes.

Results
Factor analysis yielded a one-factor solution, and the final 12-item iNAR Questionnaire had satisfactory internal reliability (alpha=0.72). Health condition and healthcare-related variables accounted for 14% of the variance of iNAR behaviours, whereas sociodemographics and irrational beliefs did not additionally contribute.

Conclusions
We constructed a brief yet comprehensive measure of iNAR behaviours and related them to health and sociodemographic variables and irrational beliefs. The findings suggest that public health interventions should attempt to improve patients’ experiences with the system and build trust with their healthcare practitioners rather than aim at specific demographic groups or at correcting patients’ unfounded beliefs.

Study registration
The design and confirmatory analyses plan were preregistered (https://osf.io/pnugm).

This study examines prevalence of iron deficiency among females aged 12 to 21 years to inform future screening strategies for iron deficiency and iron-deficiency anemia.