Risultati per: Short Acting Opioid

This study uses electronic medical record data to compare 48-week viral load outcomes after starting long-acting antiretroviral therapy among people in the US with HIV with or without viremia from January 2021 through September 2024.

The US Food and Drug Administration (FDA) recently approved the rapid-acting human insulin analog insulin-aspart-szjj, marketed as Merilog, as a biosimilar to insulin aspart (Novolog).

Introduction
The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA).

Methods
A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres).

Ethics and dissemination
The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.

Trial registration number
NCT06185452/EUCT number: 2023-503963-41-00.

This Medical News article discusses lawsuits filed by the US Department of Justice against CVS and Walgreens, two of the nation’s largest pharmacies, for their alleged role in exacerbating the opioid crisis by dispensing “massive quantities” of the drugs.

This study uses 2021 data on the percentage of unavailable opioid tests in the US to examine how opioid involvement informs injury death investigations.

Objective
This scoping review aimed to map the content, duration, delivery methods and modes of assessment for paediatric oncology nursing education and training programmes.

Design
Scoping review.

Data sources
Published articles were retrieved from Cumulative Index to Nursing and Allied Health Literature, Dimensions, Embase, PubMed and Scopus. Additional articles were identified from the reference list of the included studies.

Eligibility criteria
Articles that described or reported on a paediatric oncology nursing education and training programme, from any setting, published in English from 2012 to 2022.

Data extraction and synthesis
Two reviewers independently screened the titles, abstracts and full texts. Data were extracted using a standardised data extraction tool. Content analysis using basic coding of data was performed. The findings are presented in figures and tables, and the results are described narratively.

Results
This review included 15 articles. Content identified for paediatric oncology education and training programmes included supportive care, chemotherapy, overview of paediatric oncology, management of venous access devices, oncological emergencies, nursing considerations, infection prevention and control, paediatric cancers, patient and family education, communication, ethical legal considerations, grief and bereavement, and overview of haematological cancers. Didactic methods used included traditional face-to-face and virtual approaches to deliver theoretical and practical content. The duration of the programmes ranged from 2 hours to 6 months. Both qualitative and quantitative methods of assessment were used before, during and after the training.

Conclusion
This review offers valuable insights for the development of paediatric oncology education and training programmes for nurses. It provides comprehensive guidance on key content, duration, delivery methods and modes of assessment. However, there is a need to consider context-specific issues and availability of resources when developing the programmes to ensure relevance and sustainability.

Study registration
Open Science Framework (https://doi.org/10.17605/OSF.IO/X3Q4H).

Introduction
The opioid crisis is a significant burden on adolescent public health in the USA. Medical use of prescription opioids is a pathway via which adolescents transition to opioid misuse, opioid use disorder and overdose. More than half of all opioids prescribed to adolescents are for pain management following surgery. Yet, little is known about the critical period following surgery during which adolescents initiate opioid misuse or the modifiable mechanisms (such as sleep deficiency) contributing to this process. This prospective observational study will broaden our knowledge by examining associations between sleep deficiency and opioid use and misuse following surgery. We will also examine behavioural, psychological, family and social factors linking sleep deficiency with opioid use and misuse.

Methods and analysis
Adolescents (10–19 years) undergoing outpatient orthopaedic surgery, along with one parent, will be recruited from two paediatric hospitals, for a sample of 400 dyads. Adolescents will be assessed at six timepoints. Before surgery, participants will undergo comprehensive multimodal sleep assessments (sleep surveys and actigraphy). Participants will also report on previous substance use, pain intensity and psychosocial, family and social factors. Adolescents will then be closely monitored over the first 14 days following surgery using ecological momentary assessment methods to capture real-time, naturalistic, daily data on sleep, opioid use, pain and psychological factors (including mood, affect and subjective response to opioid use). Opioid use (total number of doses and duration) will be measured with an innovative electronic medication monitoring device following surgery. Follow-up assessments at 3 months, 6 months, 12 months and 24 months will track the development of opioid misuse over time. Our primary outcomes include opioid use during the immediate 14 days following surgery and the presence of opioid misuse at 24 months after surgery. Multilevel mediation models will determine associations between predictor variables and acute postsurgical opioid use. We will apply modern machine learning algorithms to develop and validate models predicting adolescent prescription opioid misuse at 24 months from surgery.

Ethics and dissemination
This study was approved by Advarra’s Center for Institutional Review Board Intelligence (CIRBI) (Protocol 00072049), which serves as the single IRB of record for this multisite study.

This multicenter cohort study assesses the association of an additional rituximab infusion at month 6 in patients with pemphigus who were in complete remission and had at least 1 predictor of relapse.

This randomized clinical trial evaluates optionally switching to buprenorphine as a strategy for improving pain and reducing opioids among patients prescribed high-dose, full agonist long-term opioid therapy.

This interrupted time-series cohort study examines the association of the 2019 Medicare opioid safety edits with changes in opioid use among beneficiaries with disabilities.

This randomized clinical trial evaluates the effectiveness of an intervention combining nicotine replacement with brief behavioral support in reducing cigarette use among adults with opioid dependency in Norway.

Objectives
To investigate long-acting injectable (LAI) antipsychotic prescribing patterns and their associations with transition and continuation of care and healthcare resource utilisation (HCRU) for patients with schizophrenia in the USA.

Design
A retrospective cohort study.

Setting
Electronic health record data from adults in the USA with schizophrenia were extracted from the NeuroBlu Database V.21R2.

Participants
Adults (aged ≥18 years) with a schizophrenia diagnosis who initiated LAI antipsychotic treatment during psychiatric inpatient admission. The index date was the date of LAI initiation. Patients who had ≥1 primary, secondary or tertiary ICD-9/10 (International Classification of Diseases) diagnosis of schizophrenia at clinical sites that had both inpatient and outpatient facilities were included.

Primary outcome measures
Transition-of-care (eg, risk of rehospitalisation, number of hospital readmissions, number of outpatient visits post discharge), continuation-of-care (eg, first treatment path after discharge, time to index LAI discontinuation and number of patients who restarted LAIs after discontinuation) and HCRU endpoints (eg, length of stay of index hospitalisation and estimated cost for psychiatric outpatient visits pre-index and post-index) were the primary outcome measures.

Results
A total of 1197 patients were included who initiated an LAI in an inpatient setting. Of 339 patients with ≥3 months pre-index and post-index data, median time to rehospitalisation was 135 days. Patients discharged taking an LAI alone had lower frequency of rehospitalisation (incidence rate ratio (IRR)=0.62 (95% CI, 0.46 to 0.84)), lower risk of longer hospital stays (IRR=0.60 (95% CI, 0.43 to 0.84)), lower risk of becoming rehospitalised (HR=0.49 (95% CI, 0.35 to 0.69)) and lower risk of outpatient visits (IRR=0.50 (95% CI, 0.36 to 0.70)) versus patients co-prescribed an oral antipsychotic (LAI+OA). Patients discharged taking an LAI dosed once every 1–2 months or once every 2 weeks had lower frequency of rehospitalisation (IRR=0.85 (95% CI, 0.64 to 1.14)), lower risk of longer hospital stays (IRR=0.90 (95% CI, 0.70 to 1.15)) and lower risk of becoming rehospitalised versus an LAI dosed once every 2 weeks; risk of becoming rehospitalised was no different (HR=1.00 (95% CI, 0.76 to 1.32)) and risk of outpatient visits was greater (IRR=1.25 (95% CI, 0.96 to 1.63)). During hospitalisation, 73.4% of patients were co-prescribed an OA, most frequently risperidone, with their index LAI. From pre-admission to post-discharge, psychiatric clinic costs significantly increased (US$14 231, p

Objective
Short-chain fatty acids (SCFA) play a role in modulating glucose metabolism and are influenced by diet. Alterations in the SCFA-producing microbial ecosystem in individuals with type 1 diabetes (T1D) may contribute to impaired glycaemic control. This study investigated the relationships between serum SCFA levels, blood glucose control, and dietary habits in adults with T1D.

Design
Observational study.

Setting
The study was conducted at the diabetes outpatient clinic of Federico II University Teaching Hospital, Naples, Italy.

Population
The study included 198 adults with T1D (100 men and 98 women), aged 18–79 years.

Main outcome measures
Serum SCFA levels, blood glucose control, assessed by glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics, and dietary intake from a 7-day food record.

Results
SCFA levels showed significant sex-specific differences (p180 mg/dL) (32.2±12.6% vs 41.2±17.2%, low tertile; p=0.011) and improved glucose management indicator (7.1±0.6% vs 7.5±0.6%, low tertile; p=0.027). Regarding eating habits, higher acetate tertiles were associated with higher intakes of total fat (p=0.041), polyunsaturated fatty acids (p=0.049) and monounsaturated fatty acids (p=0.021) in men only.

Conclusion
These findings reveal a sex-specific association between serum propionate levels and blood glucose control in women with T1D. Importantly, this relationship appears independent of dietary factors.

Trial registration number
NCT05936242.

Objectives
This study aimed to further develop and cross-validate a short questionnaire to measure self-reported Positive Health in general (Dutch) populations for evaluative purposes, stemming from the original 42 items of the My Positive Health (MPH) dialogue tool. Positive Health refers to ‘health from the perspective of patients and citizens’ following the concept of Huber et al.

Design and setting
A cross-sectional study was performed among a panel representative for the general adult Dutch population living at home.

Participants
The response rate was 76%, 1327 of a total of 2457 respondents were female, and mean age (years) was 53.3±17.8.

Methods
First, item reduction was carried out through content discussions following statistical output retrieved from factor structures and loadings, inter-item correlations and internal consistency (Cronbach’s alpha). Next, among the other half of the study population, measurement properties for the developed short questionnaire were calculated using goodness of fit indices from confirmatory factor analysis (CFA).

Results
The item reduction process (n=1199) resulted in a questionnaire of 22 items (PH22) with a four-factor structure and explained variance of 62.4%. Cronbach’s alpha values were 0.84, 0.92, 0.81 and 0.78 for the renamed factors ‘Physical fitness’ (5 items), ‘Contentment with self, others and life’ (nine items), ‘Daily life management’ (5 items) and ‘Future perspective’ (3 items), respectively. Cross-validation (n=1258) showed adequate goodness-of-fit indices of the PH22, based on both first-order and second-order CFA. The scores of the PH22 were normally distributed. No floor or ceiling effects were present.

Conclusions
A short 22-item questionnaire to measure self-reported Positive Health in a general (Dutch) population for evaluative purposes such as scientific or policy research at Positive Health or patient-centred interventions was developed and cross-validated, named PH22. This study supports its structural validity. To use this questionnaire in practice, its test-retest reliability and responsiveness should also be known. Future research has to reveal this.

Objectives
This study aimed to investigate the safety and effectiveness of opioid-free anaesthesia (OFA) versus conventional opioid anaesthesia (OA) for postoperative pain management and recovery in patients undergoing laparoscopic surgery.

Design
Systematic review and meta-analysis.

Data sources
The databases of PubMed, Embase, Cochrane Library and Web of Science were searched from inception to August 2023.

Eligibility criteria for selecting studies
We included any randomised controlled trial comparing OFA (at least two drugs or two more alternatives to opioids) with OA for laparoscopic surgery. The primary outcomes included postoperative pain scores, measured on a Numerical Rating Scale or Visual Analogue Scale ranging from 0 to 10, at 0–2 hours and 24 hours postoperatively; postoperative analgesic consumption, measured in morphine equivalent doses (mg); and quality of recovery, assessed using the QoR-40 score (ranging from 40 to 200). The secondary outcomes included the incidence of postoperative nausea and vomiting (PONV), antiemetic use, extubation time (measured in minutes), post-anaesthesia care unit discharge time (measured in minutes), shivering, bradycardia, hypotension and pruritus.

Data extraction and synthesis
Meta-analyses were performed using Stata16 software, using the DerSimonian and Laird’s method and inverse variance to summarise effect sizes for each outcome under a random effects model for all outcomes. Outcomes were reported as OR for binary outcome indicators and mean difference (MD) for continuous outcome indicators, with corresponding 95% CIs. I² coefficients were used to assess high, medium and low heterogeneity. RoB was used to assess the risk of bias of the included studies. GRADE assessed the certainty of the evidence using a systematic framework for rating the quality of evidence and strength of recommendations.

Results
Ultimately, 12 studies involving 983 patients undergoing laparoscopic surgery were included in this systematic evaluation and meta-analysis. The results of the meta-analysis showed an association of OFA with reduced early postoperative 0–2-hour pain response (MD –1.29; 95% CI –2.23 to –0.36; I²=92%; p