Risultati per: L’aderenza terapeutica, i device inalatori e l’asma bronchiale

Stroke, Volume 56, Issue 2, Page e101-e101, February 1, 2025.

Purpose
This paper describes the data collection and management methods for the Cancer Prevention Study-3 (CPS-3) Accelerometry Substudy, a nested cohort of device-based physical activity and sedentary time data.

Participants
US-based CPS-3 participants (initially enrolled 2006–2013) who completed the 2018 follow-up survey and had a valid email address were invited to the Accelerometry Substudy (n=109 780). Among the 23 111 participants who registered and were shipped an ActiGraph GT3X+ accelerometer, 21 219 participants returned the device with a complete wear log (91.8%) and 20 950 (90.6%) provided at least three adherent days of data (eg, days with at least 10 hours of wear).

Findings to date
Participants with ≥3 adherent days were predominantly female (n=16 187, 77.3%), non-Latino white (n=17 977, 85.8%) and had an average age of 58 years (SD=9.8). The median daily wear time was 15.3 hours, which did not vary considerably by wear day. The median time spent in moderate-intensity aerobic physical activity was 29 min/day (IQR=36), and the median time in vigorous physical activity was 3 min/day (IQR=13). Participants were sedentary for 9.4 hours (564 min, IQR=171 min) and accumulated a median of 6474 steps per day (IQR=5348).

Future plans
The full CPS-3 cohort will be linked with the National Death Index and state cancer registries biennially. Participants will be sent triennial surveys for the next two decades. Future analyses within the CPS-3 Accelerometry Substudy more specifically aim to identify relationships between physical activity, sedentary time and health outcomes, primarily cancer incidence, survival and survivorship.

This Medical News article is an interview with Jeffrey S. A. Stringer, MD, whose commitment to global health equity has led to advancements in artificial intelligence-enabled tools that can accurately estimate gestational age during pregnancy without trained sonographers.

The 1976 Medical Device Amendments granted the US Food and Drug Administration (FDA) regulatory authority over medical devices. The FDA’s regulatory review requirements are intended to correspond to the amount of information needed to provide “reasonable assurance of device safety and effectiveness” and establish a 3-tiered system for classifying devices based on their risk profile (low, moderate, and high) with a corresponding degree of evidence required for review. Low-risk devices are typically only subject to general controls (eg, good manufacturing practices) and exempt from premarket review. Nearly 90% of medical devices that undergo regulatory review are classified as moderate risk and receive authorization through the 510(k) process, which additionally requires manufacturers to demonstrate “substantial equivalence” to a previously authorized (predicate) device, usually without being required to show evidence of device safety and effectiveness from clinical studies. Devices in the third category, high risk, are fewer in number, frequently implanted and/or life-sustaining, and undergo the most rigorous regulatory review through the premarket approval pathway, which requires evidence from clinical studies demonstrating safety and effectiveness.

Introduction
The intrauterine device (IUD) inserted immediately after delivery is a safe and effective measure for preventing unplanned pregnancies. Despite exhibiting a higher expulsion rate compared with later insertions, it proves cost-effective due to the high rate of continuity of the method. There is still a gap in the literature regarding the optimal strategy for monitoring these patients, whether it should be through clinical examination, ultrasound or both. The aim of this review is to map the available evidence regarding the proper clinical and ultrasound follow-up procedures of IUDs inserted immediately post partum.

Methods and analysis
Using the well-established scoping review methodology outlined by the Joanna Briggs Institute, a five-stage review is outlined: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. The search strategy will be applied to nine databases reflecting empirical and grey literature. A two-step screening process will be used to determine eligibility of articles. To be included in the review, articles must describe how postpartum women (adolescents or adults) who had an IUD inserted immediately after birth (vaginal or caesarean) were followed up. All articles will be independently assessed for eligibility, and data from eligible articles will be extracted and charted using a standardised form. Extracted data will be analysed using narrative and descriptive analyses.

Ethics and dissemination
Ethics approval is not required. The results will be disseminated to the health science community through professional networks, conference presentations and publication in a scientific journal.

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Introduction
The communication of information about the risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviours among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with behavioural changes in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects of communicating genetic risk for T2D alone or in combination with wearable device functions on wearable device-measured PA among overweight or obese East Asians.

Methods and analysis
In a parallel group, randomised controlled trial, 355 overweight or obese East Asian individuals aged 40–60 years are allocated into one of three groups: one control and two intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 single-nucleotide polymorphisms associated with T2D among East Asians. All three groups receive a Fitbit device. Both intervention groups will receive T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups additionally uses Fitbit’s step goal setting and prompt functions. Questionnaires and physical measurements are administered at baseline, immediately after intervention delivery, and 6 and 12 months post intervention. The primary outcome is time spent in moderate-to-vigorous PA from the Fitbit, which will be assessed at baseline, immediately post intervention, 12 months post intervention and at 6-month follow-up. Secondary outcomes include other wearable device-measured parameters, sedentary time, and sleep, blood pressure, metabolic risk markers, hand grip strength, self-reported PA, fruit and vegetable consumption, smoking, and psychological variables. Between-group differences in the continuous and categorical variables collected at baseline will be examined using Analysis of Variance (ANOVA) and 2 tests, respectively. A series of linear mixed effects models with fixed effects of time, group and interaction between time and group will be performed, with adjustment for potential confounders.

Ethics and dissemination
The study protocol has undergone review and received approval from the ethics committee of the University of Hong Kong. Findings from our trial will be disseminated through publication in peer-reviewed research journals and presented at international academic conferences.

Trial registration number
ClinicalTrials.gov, NCT05524909. https://register.clinicaltrials.gov/ (11 November 2024).

Esperto, ‘Una nuova speranza per migliorare la sopravvivenza e la qualità di vita dei pazienti’

Stroke, Ahead of Print. BACKGROUND:Lack of a dedicated thrombectomy device for cerebral venous thrombosis hinders the recanalization ability of endovascular treatment (EVT). Novel NiTi-braided stent retriever (Venous-TD) is a dedicated venous sinus thrombectomy device. This study aims to demonstrate the safety and efficacy of Venous-TD.METHODS:In this pilot, prospective, randomized, single-blind, parallel-group control, single-center clinical study, patients with cerebral venous thrombosis from Beijing Xuanwu Hospital were included. Randomization was performed to EVT with either the Venous-TD or Angioguard with Sterling balloon (control group). The primary efficacy outcome was the proportion of immediate complete recanalization during EVT. Secondary outcomes included the proportion of functional independence and moderate to severe residential headache at 180 days after EVT. Safety outcomes included peri-procedural complications, all-cause mortality, and symptomatic intracranial hemorrhage after EVT.RESULTS:A total of 61 patients were enrolled and randomized. Thirty-one patients were randomized to the Venous-TD group, and 30 were randomized to the control group. The median (interquartile range) age was 28 (21–45) in the Venous-TD group and 34 (24–43) in the control group. The proportion of patients with a National Institutes of Health Stroke Scale score >8 on admission was 8 (25.8%) in the Venous-TD group and 11 (36.7%) in the control group. During EVT, Venous-TD significantly improved the proportion of complete recanalization compared with Angioguard (23 [76.7%] versus 6 [20.0%]; relative risk, 3.833 [95% CI, 1.825–8.054]). The proportions of long-term functional independence at 180 days in the Venous-TD group and the control group were not significantly different. The proportion of patients with severe residual headache at 180 days in the Venous-TD group was significantly lower than that in the control group (3 [9.7%] versus 10 [35.7%]; relative risk, 0.271 [95% CI, 0.083–0.886]). Safety outcomes showed no statistically significant difference between the 2 groups.CONCLUSIONS:This trial indicated that Venous-TD did not increase complications in EVT of cerebral venous thrombosis and can significantly increase the proportion of complete recanalization. A multicenter phase III randomized control trial assessing efficacy and safety of Venous-TD is warranted.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT05291585

Closure of the atrial appendage was superior to oral anticoagulation in safety and noninferior in effectiveness.

Stroke, Ahead of Print. BACKGROUND:The EXCELLENT registry aimed to evaluate the effectiveness of the EMBOTRAP Revascularization Device in an all-comer population in a real-world setting, with a focus on the composition of retrieved clots.METHODS:EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee.RESULTS:After screening 3799 patients, a total of 997 subjects (mean age, 70.0±14.2 years; 51.8% women; 19.7% non-White) were included. The first-pass modified Treatment in Cerebral Infarction (mTICI) ≥2b rate was 64.5% (623/966), first-pass mTICI ≥2c was 39.1% (378/966), and final mTICI ≥2b was 94.5% (931/985). A total of 427/912 (46.8%) patients achieved a 90-day modified Rankin Scale of 0 to 2 or ≤baseline. Embolization to a new territory occurred in 0.2% (2/984), and symptomatic intracranial hemorrhage at 24 hours in 1.6% (16/997). The 90-day mortality was 19.1% (175/918). Device- and/or procedure-related serious adverse events occurred in 5.9% (54/912) through 90 days. The mean RBC percentage of retrieved clots was 45.62±21.372. Among patients who achieved mTICI ≥2b with the first pass, 15.7% (52/331) and 9.7% (32/331), respectively, had RBC-poor (75%) clots. Patients with no clot retrieved in any procedural pass had a lower percentage of hyperdense or susceptibility vessel sign on baseline imaging (58.9% versus 74.7%;P

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Circulation, Volume 150, Issue 21, Page 1669-1670, November 19, 2024.

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