Search Results for: Short Acting Opioid

Background
Supervised injecting facilities (SIFs) are designed to reduce the harms associated with injecting drug use and improve access to health and support services for people who need them. The Supervised Injecting Room Cohort Study (SIRX) aims to provide evidence of the effects, including cost-effectiveness, of a SIF embedded within a community health service, the Melbourne Medically Supervised Injecting Room (MSIR), which has a range of integrated harm reduction, health and social support services on-site.

Methods and analysis
The SIRX study design involves two prospective cohort studies that collect behavioural data and retrospectively and prospectively linked administrative data for primary and tertiary health services, criminal justice records, and mortality. The two cohorts are: (1) participants drawn from the existing Melbourne Injecting Drug User Cohort Study (SuperMIX; established in 2008–ongoing) through which participants consent to annual behavioural surveys (including serological testing for HIV and hepatitis B and C viruses) and linkage to administrative data; and (2) the SIRX-Registration Cohort (SIRX-R; established in 2024) comprising registered MSIR clients who consent to a baseline behavioural survey and administrative data linkage including the frequency of SIF use, and the uptake of on-site services. Primary outcomes are aligned to the legislated aims of the Melbourne MSIR, including ambulance-attended non-fatal overdoses and all-cause and drug-related mortality. Using causal inference methods, analyses will estimate the effect of MSIR exposure (frequent use/infrequent use/no use) on these primary outcomes. The SIRX study also has a secondary focus on the effect of MSIR exposure on health service use and related outcomes.

Ethics and dissemination
SuperMIX Study (599/21) and SIRX-R Study (71/23) ethics approvals were obtained from Alfred Hospital Research Ethics Committee. Participants will be assessed for capacity to provide informed consent following a detailed explanation of the study. Participants are informed of their right to withdraw from the study at any time and that withdrawing does not impact their access to services. Aggregated research results will be disseminated via presentations at national and international scientific conferences and publications in peer-reviewed journals. Local-level reports and outputs will be distributed to key study stakeholders and policymakers. Summary findings via accessible outputs (eg, short infographic summaries) for participants will be displayed in relevant services including the Melbourne MSIR and the study van, and distributed via Harm Reduction Victoria.

The risk of microbial infections is increased in cirrhosis and other forms of advanced liver disease such as alcohol-associated hepatitis. Such infections may precipitate new or further decompensation and death, especially in patients with clinical features of acute-on-chronic liver failure. The severe immune dysfunction or “immune paralysis” caused by advanced liver disease is associated with high short-term mortality. However, the pathogenic mechanisms underlying immune dysfunction and immunodeficiency are incompletely understood.

Objectives
The widespread use of proton pump inhibitors (PPIs) raised concerns on the safety of long-term use of these drugs. Community pharmacists have great responsibility of educating patients on these drugs which requires having adequate knowledge. The aim of this study was to assess the practices and knowledge of community pharmacists regarding PPIs.

Design
This was a cross-sectional study conducted by filling in a questionnaire. The questionnaire was developed after a comprehensive literature review and assessed knowledge and practices.

Settings
Community pharmacists with at least 1 year of experience working in a community pharmacy were enrolled in the study.

Participants
Community pharmacists with at least 1 year of experience working in a community pharmacy were enrolled in the study.

Primary outcome measures
The knowledge, attitudes, and practices of community pharmacists towards PPIs dispensing.

Results
A total of 459 community pharmacists were approached for participation in the study, 451 (98.3%) community pharmacists agreed to be enrolled. The most dispensed PPIs in Jordan were lansoprazole and the most commonly treated medical condition with PPIs was gastric ulcer. PPIs were dispensed by the pharmacists very frequently and one-fourth of the participants did not review instructions with patients to ensure their proper use of PPIs. Participants had an average knowledge of 6.1±1.7 (the highest knowledge score is 12). More than one-third of participants (180, 39.9%) had inadequate knowledge (a score of less than 6). Being a PharmD graduate was the only significant factor that predicted adequate knowledge in the logistic regression model, with an adjusted OR of 5.671, p=0.002.

Conclusion
To provide adequate pharmaceutical care services, community pharmacists must possess appropriate knowledge on different aspects of PPIs concerning administration, efficacy and long-term and short-term side effects.

Objectives
The primary objectives were to identify the predictors of new permanent pacemaker implantation in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). The secondary objectives were to investigate the temporal changes in permanent pacemaker implantation following TAVI and its impact on long-term prognosis.

Design
Prospective observational cohort study of patients with AS undergoing TAVI.

Setting
Single-centre study conducted at a tertiary hospital in Western Norway between 2012 and 2019.

Participants
Among 600 consecutive patients with severe AS who were treated with TAVI, 52 patients with permanent pacemaker prior to TAVI were excluded. The remaining 548 patients were included in the present study.

Baseline measures
An evaluation of baseline risk factors, 12-lead ECG and echocardiography.

Primary outcome measures
The need for a new pacemaker implantation ≤30 days following TAVI and all-cause death.

Results
The mean age was 80.6±6.7 years, and 50% were males. Among the 548 eligible patients, 173 (31.6%) underwent pacemaker implantation ≤30 days following TAVI, evenly distributed between females and males (29.6% vs 33.6%, p=0.317), with higher implant rates at low-volume phase (2012–2015) and lower implant rates at high-volume phase (2016–2019) (45.8% vs 23.9%, p

Introduction
Internationally, breast cancer is the second most diagnosed cancer with approximately 2.3 million people diagnosed each year. 40% will require a mastectomy which has an average length of hospital stay of 1–2 days. Enhanced Recovery After Surgery (ERAS) guidelines include the following patient-managed recommendations: early mobilisation, early eating and drinking, opioid minimisation and physiotherapy exercises. Low adherence rates to these recommendations suggest that patients need support to do these things. A digital health intervention (DHI) may provide an effective, cost-effective and scalable solution. This pilot trial aims to assess the feasibility of conducting a trial of RecoverEsupport and the acceptability of the RecoverEsupport intervention to support patients to recover from breast cancer surgery.

Methods and analysis
Participants will be recruited from the perioperative clinic and breast surgery units at a major cancer hospital in New South Wales, Australia and randomised (1:1) to receive (1) control: usual care or (2) intervention: usual care plus RecoverEsupport. The DHI incorporates the following evidence-based behaviour change strategies: education, self-monitoring and feedback and prompts and cues. The primary trial aims are to assess the feasibility of the trial and the acceptability of the RecoverEsupport intervention. The secondary aims are to assess preliminary efficacy and cost-effectiveness regarding the length of hospital stay. Data regarding patient behaviours related to patient-managed ERAS recommendations, Quality of Life, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Quality of Recovery (QOR-15), Anxiety (Hospital Anxiety and Depression Scale), hospital readmissions, emergency department presentations and health service utilisation postdischarge will also be collected.

Ethics and dissemination
This study has been approved by the Human Research Ethics Committees of the Hunter New England Local Health District (2022/ETH02010), the University of Newcastle (H-2023–0298) and the Calvary Mater Newcastle (2022/STE03757). Trial outcomes will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624000417583.

Objectives
To assess the beneficial and harmful effects of duloxetine versus ‘active placebo’, placebo or no intervention for adults with major depressive disorder.

Design
Systematic review with meta-analysis and trial sequential analysis of randomised trials.

Data sources
Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO and other relevant databases up until January 2023. We requested clinical study reports from 36 competent authorities.

Eligibility criteria for selecting studies
All randomised clinical trials comparing duloxetine versus placebo, ‘active placebo’ or no intervention, irrespective of publication type, publication status, publication year and language for treatment of major depressive disorder in adults.

Data extraction and synthesis
Five authors in pairs extracted data using a standardised data extraction sheet. A third review author was consulted for disagreements. Intervention effects were assessed by both random-effects and fixed-effect model meta-analyses, risk of bias assessments were performed by two independent review authors using Cochrane’s risk of bias tool V.2 and the certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.

Results
We included 28 trials randomising a total of 7872 participants. All results were at high risk of bias. The trials’ assessment time points were between 6 and 16 weeks after randomisation. Meta-analyses showed evidence of a beneficial effect of duloxetine on depressive symptoms (mean difference –1.81, Hamilton Depression Rating Scale (HDRS-17) points; 95% CI –2.34 to –1.28; heterogeneity I2=0.0%; 12 trials) and quality of life (mean difference –3.79 points, 95% CI –5.11 to –2.46; I2=0.0%; three trials), but the effect sizes were below our predefined minimal clinically important differences. Trial sequential analysis showed that we did not have enough information to assess the effects of duloxetine on serious adverse events (SAEs) (OR 0.67, 95% CI 0.44 to 1.02; I2=0.0%; 19 trials) or suicide or suicide attempts (OR 1.08, 95% CI 0.37 to 3.16; six trials). Duloxetine increased the risk of non-SAEs (risk ratio 1.27, 95% CI 1.22 to 1.32; I2=73.0%; 24 trials). The adverse events with the lowest number needed to harm (NNH) were nausea (NNH 6), dry mouth (NNH 13), somnolence (NNH 17), withdrawal syndrome (NNH 19), sweating (NNH 20), dizziness (NNH 21) and constipation (NNH 21).

Conclusions
Duloxetine appears to reduce depressive symptom scores and improve quality of life scores in the short term, but the effect sizes are minimal and of questionable patient importance. The short- and long-term effects of duloxetine on risks of SAEs and suicidality are uncertain. Duloxetine increases the risks of several short-term adverse events. Systematic assessments of benefits and harms over longer periods are required.

Trial registration number
PROSPERO 2016 CRD42016053931.

Background and aims
RNA interference has been extensively explored in patients with chronic hepatitis B (CHB) infection. We aimed to characterise the long-term efficacy of small interfering RNA (siRNA) on hepatitis B surface antigen (HBsAg) suppression.

Methods
We prospectively followed up participants with CHB who received siRNA, either ARC-520 or JNJ-73763989 (JNJ-3989), in combination with nucleoside analogue (NUC) in our centre. Participants enrolled included 15 receiving 4 monthly injections of ARC-520, 38 receiving 3 injections of JNJ-3989 at 1, 2 or 4 weekly intervals and 5 receiving placebo in previous clinical trials. Serial blood sampling was performed according to the original protocols and on completion every 24 weeks until last follow-up (LFU) with mean duration of 52.5 months.

Results
Among the 53 NUC+siRNA-treated participants (mean age 46.8, baseline HBsAg 3.08 log, 83% previously on NUC, 34% hepatitis B e antigen+), the proportion of patients achieving HBsAg seroclearance or

The remarkable success of direct-acting antivirals in curing hepatitis C led to concerted efforts in developing a cure for hepatitis B. Unlike hepatitis C, it is accepted that a sterilising cure is not feasible in the foreseeable future. Instead, functional cure defined as hepatitis B surface antigen (HBsAg) loss (below detection) and HBV DNA suppression (below quantification) sustained for at least 24 weeks after completion of treatment has been embraced.1 Nucleos(t)ide analogues (NA) currently in use, entecavir and tenofovir, are highly effective in maintaining suppression of HBV DNA replication and yields substantial clinical benefits including reduced rates of cirrhosis and hepatocellular carcinoma, but HBsAg loss remains elusive. Yet, if a functional cure is achieved, the benefits are multiple, with further reductions in the risk for liver-related outcomes,2 elimination of the need for long-term monitoring and NA treatment and addressing the stigma associated with HBsAg-positivity. Strategies…

An estimated 9% of people in the US aged 2 years or older had anemia from August 2021 to August 2023, according to data from the National Center for Health Statistics (NCHS). Overall, 13% of females had anemia compared with about 6% of males, and prevalence was highest among females during adolescence through midlife. Like most nations charged with reducing anemia prevalence, the US fell short of the World Health Assembly’s goals to curb the condition in women of reproductive age by half by 2025.

Objective
The primary study aims were to evaluate the implementation, mechanisms and context of a timely short-term specialised palliative care intervention for older people with frailty (Frailty+ intervention) as well as to assess the feasibility of a randomised controlled trial to evaluate Frailty+. Our secondary aim was to describe any preliminary effects of Frailty+.

Design
Pilot randomised controlled trial with process evaluation.

Setting/Participants
We aimed to recruit 50 adults (≥70 years) with Clinical Frailty Scale score 5–7, and complex care needs and their main family carer, if available, from two Belgian hospitals on discharge.

Interventions
Patients were randomised to the Frailty+ intervention alongside standard care or standard care alone.

Outcome measures
Implementation and trial feasibility were assessed through interviews, focus groups and quantitative data. The primary outcome to be used in a potential full-scale trial if the study is feasible and implementable was mean change in five palliative care symptoms over 8 weeks.

Results
We enrolled 37 patients (19 intervention, 18 control) and 26 family carers (15 intervention, 11 control). Patients and family carers valued the home visits from palliative care nurses, and nurses saw value in Frailty+. But most patients received only one visit over 8 weeks, and nurses did not organise foreseen multidisciplinary meetings, referring to absence of urgent needs. Many aspects of the trial methods were feasible, but recruitment was challenging. The baseline mean score on the five palliative care symptoms was 6.0 and 5.6 in intervention and control group, respectively; and 4.5 and 4.1 at 8 weeks (adjusted ratio 1.0, ie, no effects on symptoms).

Conclusions
While Frailty+ was generally welcomed by older people with frailty, families and palliative care nurses, our process evaluation uncovered multiple barriers, mostly rooted in the current organisation of specialised palliative care that is tailored to advanced stages of illness. Ensuring timely access requires efforts beyond timely referral alone, and implies profound organisational and cultural change.

Trial registration number
ISRCTN39282347.

This randomized clinical trial compares the effectiveness of an integrated pain team vs pharmacist collaborative management on pain and opioid dosage.

This cross-sectional study assesses acquisitions of US opioid treatment programs by private equity firms overall and at the zip-code level.

This study describes patterns of reduction in illicit opioid use of patients both labeled as a success and nonsuccess based on an abstinent-based treatment outcome rule.

Introduction
Acute uncomplicated urinary tract infection (UTI) is a common condition with potentially serious sequelae that is mostly diagnosed and managed in primary care settings. Around half of all women have a UTI in their lifetime, and a quarter experience an infection caused by organisms resistant to more than one antibiotic. Reducing inappropriate prescribing of antibiotics is a core tenet of antimicrobial stewardship. However, current diagnostics for UTI are unfit for purpose in acute (highest prescribing) settings, being too slow to inform the required immediate decision-making and often confounded by sample contamination.
Rapid point-of-care diagnostic tests (POCTs) that facilitate timely decision-making are potential solutions to this problem. Several such tests have reached advanced stages of technology readiness, but their diagnostic performance has not been evaluated in primary care with clinical users. To progress novel tests towards implementation, a diagnostic field study is required, to allow for parallel and sequential evaluation of multiple tests in a primary care population.

Methods and analysis
We will recruit participants assigned female at birth from primary care clinics in England who contact their clinic with symptoms of acute uncomplicated UTI. Eligible participants will complete a short questionnaire to capture symptoms and symptom severity and will provide a urine sample. Samples will be split and initially tested using novel index tests (POCTs) and conventional urinalysis ‘dipstick’ at the primary care clinic. The second part of the sample will be processed at a National Health Service-based reference laboratory using a modified reference standard including microscopy, microbiological culture, pathogen speciation and antimicrobial susceptibility testing. The UTI reference standard culture, although based on the national methods, is modified to provide accurate bacterial counts, better to define a microbiological diagnosis of UTI. Susceptibility testing will be performed using ‘gold-standard’ methods, not usually performed in diagnostic laboratories. The primary outcome will be the diagnostic performance (sensitivity, specificity, positive and negative predictive values) of POCTs for detection of UTI and antimicrobial susceptibility for POCTs that include antimicrobial susceptibility testing. Secondary outcomes will include the symptom profile of patients presenting with uncomplicated UTI, a theoretical determination of how use of POCT results might change prescribing, an understanding of POCT failure rate and qualitative capture of the experiences of those using the POCT to deliver the study in primary care clinics.

Ethics and dissemination
Ethical approval was received from the London Central Research Ethics Committee (23/LO/0371) and the UK Health Research Authority. We will publish the findings of The plaTform fOr Urinary tract infection diagnostiC evAluatioN evaluations in peer-reviewed medical journals and more broadly following a dissemination plan formulated by a communications specialist in consultation with patients and the public.

Trial registration number
ISRCTN80937472.

Introduction
Long-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acting insulin analogues may offer tangible clinical benefits for people with T1D. To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.

Methods and analysis
This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. The co-primary outcomes are the per cent time in serious hypoglycaemia (

Introduction
Postsurgical hypoparathyroidism (PoSH) is an iatrogenic condition that occurs as a complication of several different procedures with thyroid surgery being the most common. PoSH has significant short- and long-term morbidities. The volume of thyroid surgery is increasing, and PoSH is therefore likely to increase. Some studies have shown promising results using near-infrared fluorescence (NIRF) imaging in reducing the risk of PoSH which has the potential to significantly reduce morbidity and costs associated with monitoring and treatment.

Methods and analysis
NIFTy is an unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial in patients undergoing total or completion thyroidectomy. The trial incorporates a process evaluation (IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up framework) 2a) to inform the trial protocol, a phase II (IDEAL 2b) analysis using a surrogate primary outcome of 1 day transient hypocalcaemia to determine early futility and phase III (IDEAL 3) assessment of the primary outcome of PoSH at 6 months after surgery. 454 participants will be randomised on a 1:1 basis to evaluate thyroid surgery with NIRF and indocyanine green against standard thyroid surgery in reducing PoSH at 6 months after surgery, with the phase II analysis occurring once data are available for 200 participants. Analysis in both phases will be using multilevel logistic regression incorporating random effects with respect to surgeon and adjusting for minimisation factors. Phase III secondary outcomes include protracted hypoparathyroidism, hypercalcaemia, complications, length of stay, readmissions and patient reported quality of life using the Short Form 36 Health Survey Questionnaire and Hypoparathyroid Patient Questionnaire instruments.

Ethics and dissemination
NIFTy is funded by National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme (Grant Ref: 17/11/27) and approved by a Research Ethics Committee (reference: 21/WA/0375) and Health Research Authority (HRA). Trial results will be disseminated through conference presentations, peer-reviewed publication and through relevant patient groups.

Trial registration number
ISRCTN59074092.