Randomised clinical trial of a 16 mg vs 24 mg maintenance daily dose of buprenorphine to increase retention in treatment among people with an opioid use disorder in Rhode Island: study protocol paper

Introduction
Buprenorphine is a highly effective treatment for opioid use disorder (OUD). However, provider observations and preliminary research suggest that the current standard maintenance dose may be insufficient for suppressing withdrawal and preventing cravings among people who use or have used fentanyl. Buprenorphine dosing guidelines were based on studies among people who use heroin and have not been formally re-evaluated since fentanyl became predominant in the unregulated drug supply. We aim to compare the effectiveness of a high (24 mg) vs standard (16 mg) maintenance daily dose of buprenorphine for improving retention in treatment, decreasing the use of non-prescribed opioids, preventing cravings and reducing opioid overdose risk in patients.

Methods and analysis
Adults who are initiating or continuing buprenorphine for moderate to severe OUD and have a recent history of fentanyl use (n=250) will be recruited at four outpatient substance use treatment clinics in Rhode Island. Patients continuing buprenorphine must be on doses of 16 mg or less and have ongoing fentanyl use to be eligible. Participants will be randomly assigned 1:1 to receive either a high (24 mg) or standard (16 mg) maintenance daily dose, each with usual care, and followed for 12 months to evaluate outcomes. Providers will determine the buprenorphine initiation strategy, with the requirement that participants reach the study maintenance dose within 7 days of randomisation. Providers may adjust the maintenance dose, if clinically needed, for participant safety. The primary study outcome is retention in buprenorphine treatment at 6 months postrandomisation, measured using clinical and statewide administrative data. Other outcomes include non-prescribed opioid use and opioid cravings (secondary), as well as non-fatal or fatal opioid overdose (exploratory).

Ethics and dissemination
This protocol was approved by the Brown Institutional Review Board (STUDY00000075). Results will be presented at conferences and published in peer-reviewed journals.

Trial registration number
NCT06316830.

Leggi
Novembre 2024

Assessment of the productivity loss due to leading maternal ill-health conditions: a follow-up study of a prospective pregnancy cohort in rural Sri Lanka

Objectives
This study aimed to assess the productivity loss and cost due to maternal ill-health conditions and its associated factors throughout pregnancy in rural Sri Lanka.

Design
A follow-up study of women registered in the Rajarata Pregnancy Cohort (RaPCo).

Setting
Anuradhapura district, Sri Lanka.

Participants
1573 pregnant women who were followed up from pregnancy identification to termination.

Primary and secondary outcome measures
The primary outcome measures of this study are productivity loss due to maternal ill-health conditions expressed by days/month and productivity cost due to maternal ill-health conditions expressed in monetary terms (US$)/month. Data were collected monthly, and all pregnant women were asked to report the leading cause of maternal ill-health condition and the associated loss due to absenteeism and presenteeism.

Results
During the pregnancy follow-up, 3595 (81.5%) months had at least one episode of maternal ill-health condition. Of these, only 1729 (48.1%) episodes sought medical care. Assistance for lost routine work was reported in 1281 (35.6%) episodes. The absenteeism, presenteeism and gross and net productivity loss per month were 3.6, 4.5, 8.1 and 5.5 days/month, respectively. The corresponding productivity cost was US$15.26/month. Nausea and vomiting (NVP) reported the highest prevalence (n=1599, 44.5%) until the second month of the third trimester, presenteeism (5.5 days/month) and gross productivity loss (9.5 days/month). Pregnant women with vaginal bleeding reported the highest absenteeism (6.2 days/month) and net productivity loss (6.8 days/month). Pregnant women diagnosed with anaemia reported the highest productivity cost (US$26.98/month). Monthly household expenditure, poverty and receiving assistance were the associated factors of productivity loss (p

Leggi
Ottobre 2024

CT-Guided Thrombectomy for Large Core Stroke Up to 24 Hours

Prevailing dogma in the treatment of acute ischemic stroke has long dictated that endovascular reperfusion of large infarcted areas distal to an occluded large intracranial artery is detrimental to patient outcomes. These concerns were rooted in the presumed deleterious effects of reperfusion, most notably symptomatic intracranial hemorrhage, and in the constrained opportunity to improve outcome due to the substantial infarction already present. Indeed, the initial waves of positive randomized endovascular stroke trials addressing thrombectomy in the early time window (0-6 hours) and with imaging selection in the late time window (6-24 hours) generally excluded from enrollment patients with a large baseline infarct (core). However, among the relatively small number of patients with large core infarcts inadvertently enrolled in these trials, analyses suggested an acceptable safety profile and potential benefit of thrombectomy. These rather unexpected findings led to the launch of several randomized trials prospectively assessing the efficacy and safety of thrombectomy in patients with acute ischemic stroke presenting with a large core and proximal large vessel occlusion in the anterior circulation. Across these trials, characterization of the infarcted brain has occurred with different imaging modalities using different definitions for what constitutes a large core, but common to all trials has been a requirement that infarction already be present on computed tomography (CT) or magnetic resonance imaging (MRI) in at least 5 of the 10 regions of the Alberta Stroke Program Early CT Score (ASPECTS) scale.

Leggi
Ottobre 2024

Diabetic health literacy and associated factors among patients with diabetes attending follow-up in public hospitals of Northeastern Ethiopia: a multicentre cross-sectional study

Objective
To assess the magnitude of diabetic health literacy (DHL) and associated factors among diabetes patients attending follow-up at public hospitals in Northeastern Ethiopia.

Design
An institution-based cross-sectional study was conducted from 24 May to 24 June 2022.

Setting
Diabetic clinics of four public hospitals in Northeastern Ethiopia.

Participants
611 adult diabetes patients who have been undergoing follow-up care for at least 6 months were systematically selected. Patients who were unable to communicate, were critically ill and with gestational diabetes mellitus were excluded from the study.

Outcomes
DHL was assessed using a 15-item tool developed from existing literature.

Results
Of all the participants, 300 (49.1%) had low, 174 (28.5%) moderate and 137 (22.4%) had high DHL levels. The significant factors impacting DHL included age (

Leggi
Ottobre 2024