FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Emergency Department-initiated standard versus high-dose buprenorphine induction (ENVISION): a randomised clinical trial protocol

Por: Hawk · K. · Herring · A. · Chawarski · M. · Anderson · E. S. · Baumann · M. · Dorey · A. · Holtyn · A. F. · Jones · C. · Martel · S. · Owens · P. · Kmiecik · K. · Strout · T. D. · Taillac · P. · Lofwall · M. · Walsh · S. L. · DOnofrio · G.
Introduction

The initiation of buprenorphine for patients with opioid use disorder (OUD) in the emergency department (ED) has been associated with improved outcomes including reduced ED visits and increased treatment engagement. Though both standard-dose (8 mg buprenorphine equivalent) and high-dose (24 mg buprenorphine equivalent) strategies to initiate buprenorphine have been used in the ED, no prospective trials comparing outcomes among patients receiving these treatments have been reported.

Methods and analysis

This multisite randomised clinical trial is a multisite double-blind, double-dummy, randomised clinical trial enrolling 360 emergency department patients with moderate-to-severe OUD. Enrolled patients will be randomised to one of two study arms: standard-dose induction or high-dose induction, both provided in the ED. This study will engage, train and provide resources to five EDs throughout the US to recruit patients with untreated OUD into a randomised clinical trial. The primary aim is to evaluate the effects of the standard-dose induction and high-dose induction on rates of OUD treatment participation within 10 days post-randomisation. The secondary aims are to evaluate differences between standard-dose induction and high-dose induction on the outcomes of opioid craving, opioid withdrawal symptoms and illicit drug use assessed during 10 days post randomisation and evaluate the effects between treatment arms on rates of OUD treatment participation within 30 days post randomisation.

Ethics and dissemination

This study is funded by the National Institute on Drug Abuse and has been approved by the WCG Instutitional Review Board. It has been registered at clinicaltrials.gov. This study will inform the strategy for treatment initiation with buprenorphine among diverse ED settings and will provide ongoing evidence to support the safety and efficacy of initiating treatment for OUD in the ED.

Trial registration number

NCT06494904.

Self‐Efficacy as a Mediator Between Medication Adherence and Self‐Care in Inflammatory Bowel Disease: A Multicenter Cross‐Sectional Study

ABSTRACT

Aims

To examine the role of self-efficacy in the relationship between medication adherence and self-care behaviours in patients with Inflammatory Bowel Disease by describing their levels and exploring the interconnections among these variables.

Design

Multicenter, cross-sectional.

Methods

A total of 452 patients were recruited through consecutive non-probabilistic sampling across nine Italian outpatient Inflammatory Bowel Disease Units. Data were collected using validated tools: the Morisky Medication Adherence Scale-8, the Self-Care Self-Efficacy Scale, and the Self-Care of Chronic Illness Inventory. Descriptive statistics, Pearson correlations, and mediation analyses were performed to explore associations and the mediating role of self-efficacy between medication adherence and self-care behaviours.

Results

Participants had a mean age of 43.49 years; 50.9% were male, 49.2% had Crohn's disease, and 50.8% had ulcerative colitis. Only 10.2% reported high medication adherence, while most showed medium or low adherence. The mean self-efficacy score was 74.82. Medication adherence was positively associated with self-care maintenance, and self-efficacy statistically accounted for part of this association. Lower levels were observed in self-care monitoring and management behaviours.

Conclusions

Medication adherence was positively associated with self-care maintenance, and self-efficacy partially explained this relationship.

Implications for Clinical Practice

Routine assessment of medication adherence and self-efficacy may help identify patients at risk of poor self-care. Interventions aimed at strengthening self-efficacy, such as motivational interviewing, nurse-led counselling, and digital monitoring tools, may improve adherence and self-care maintenance.

Impact

The study addressed low medication adherence and suboptimal self-care in patients with IBD. Findings support integrating self-efficacy-enhancing strategies into multidisciplinary care to improve adherence and self-care behaviours.

Patient or Public Contribution

Patients completed validated self-report questionnaires; however, they were not involved in the study design, conduct, analysis, or manuscript preparation.

Efficacy and safety of clobetasol propionate ophthalmic nanoemulsion for treating intraocular inflammation and pain associated with cataract surgery: two phase 3 multicentre, randomised, placebo-controlled, double-masked clinical studies

Por: Schwartz · A. · Wellish · K. · Zaman · F. · Jong · K. · Sadri · E. · Martel · J. · Peace · J. · Korenfeld · M.
Objective

To assess the effect of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) on ocular inflammation and eye pain associated with cataract surgery.

Design

Two independent twin phase 3 multicentre, randomised, parallel-group, double-masked, placebo-controlled clinical studies.

Setting

The CLOSE-1 and the CLOSE-2 trials, respectively, involved 19 and 17 sites in the USA.

Participants

Patients who presented inflammation of at least five cells in the anterior chamber on the first day after routine unilateral cataract surgery

Interventions

Participants were randomised to either clobetasol or placebo four times a day for 14 days. Follow-up visits occurred on days 3, 8, 15 and 29.

Primary and secondary outcome measures

The primary endpoint was the proportion of patients with anterior chamber cell (ACC) grade 0 on day 8. A key secondary efficacy endpoint was the proportion of patients with a Visual Analogue Scale (VAS) pain score of 0 on day 8. Safety was also assessed.

Results

426 patients were randomised: 281 to the clobetasol arm and 145 to the placebo arm. The proportion of patients with ACC of 0 at day 8 was significantly superior with clobetasol (37.8% vs 18.1%; odds ratio [OR] 2.8; p

Conclusions

Clobetasol propionate ophthalmic nanoemulsion 0.05% is an effective and safe therapeutic option for treating inflammation and pain associated with cataract surgery.

Trial registration numbers

CLOSE-1 (NCT04246801) and CLOSE-2 (NCT04249076).

❌