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This randomized clinical trial investigates the relative efficacy of Mindfulness-Oriented Recovery Enhancement in addition to methadone treatment as usual compared with usual care only.
Objectives
To determine the feasibility and acceptability of ‘ACTing Minds’, a novel single-player adventure video game based on acceptance and commitment therapy (ACT).
Design
A single-arm, mixed-methods repeated measures feasibility study.
Setting
Intervention and questionnaires were completed at home by participants. Semistructured interviews were also conducted at home via the Zoom platform.
Participants
Thirty-six participants were recruited into the study, 29 completed all phases of the feasibility design. Eligibility criteria required participants to be over the age of 18 and self-reporting experiencing ongoing depression, anxiety or stress.
Intervention
Participants completed a single session of the ‘ACTing Minds’ video game, lasting approximately 1 hour, designed to educate users on key principles from ACT.
Primary outcome measures
Participant recruitment and retention, questionnaire completion, long-term intervention adherence and acceptability of the intervention. Reflexive thematic analysis was conducted on semistructured interviews run immediately postintervention and 3 weeks later.
Secondary outcome measures
Measures of depression, anxiety, stress, psychological flexibility, social connectedness and well-being were assessed at baseline, immediately following intervention completion, and after a 3-week follow-up period. We used a standardised battery of questionnaires.
Primary results
Twenty-nine participants completed the study. A reflexive thematic analysis indicated that participants responded positively to the intervention and the study at all stages. Themes reflect participants’ desire for an engaging therapeutic experience, use of game for exploring emotions, as well as their perspectives on how they had applied their learning to the real world.
Secondary results
Quantitative results indicated small to large effect sizes associated with decreases in depression (p2 = 0.011), anxiety (p2 = 0.096) and stress (p2 = 0.108), and increases in psychological flexibility (p2 = 0.060), social connectedness (p2 = 0.021), well-being (p2 = 0.011) and participation in usual activities (p2 = .307).
Conclusions
Implementation of the ‘ACTing Minds’ intervention is warranted, based on both qualitative and quantitative outcomes.
Trial registration number
NCT04566042 ClinicalTrials.gov
People with HIV-1 who received a long-acting antiretroviral treatment combining 2 drugs, cabotegravir and rilpivirine, were better able to maintain low levels of the virus compared with those who received daily oral medication, according to interim data, the National Institutes of Health (NIH) announced. The US Food and Drug Administration approved the combination of cabotegravir and rilpivirine, marketed as Cabenuva, as a once-monthly injectable for adults in 2021.
Introduction
Prescribing long-term opioid therapy is a nuanced clinical decision requiring careful consideration of risks versus benefits. Our goal is to understand patient, provider and context factors that impact the decision to prescribe opioids in patients with cancer.
Methods
We conducted a secondary analysis of the raw semistructured interview data gathered from 42 prescribers who participated in one of two aligned concurrent qualitative studies in the USA and Australia. We conducted a two-part analysis of the interview: first identifying all factors influencing long-term prescribing and second open coding-related content for themes.
Results
Factors that influence long-term opioid prescribing for cancer-related pain clustered under three key domains (patient-related, provider-related and practice-related factors) each with several themes. Domain 1: Patient factors related to provider–patient continuity, patient personality, the patient’s social context and patient characteristics including racial/ethnic identity, housing and socioeconomic status. Domain 2: Provider-related factors centred around provider ‘personal experience and expertise’, training and time availability. Domain 3: Practice-related factors included healthcare interventions to promote safer opioid practices and accessibility of quality alternative pain therapies.
Conclusion
Despite the differences in the contexts of the two countries, providers consider similar patient, provider and practice-related factors when long-term prescribing opioids for patients with cancer. Some of these factors may be categorised as cognitive biases that may intersect in an already disadvantaged patient and exacerbate disparities in the treatment of their pain. A more systematic understanding of these factors and how they impact the quality of care can inform appropriate interventions.
In a unique review, experts discuss conditions for which warfarin or antiplatelet drugs are preferable to DOACs and conditions for which DOAC safety and efficacy is uncertain.
Objective
To investigate the association between opioid replacement therapy (ORT) and benzodiazepine (BZD) coprescription and all-cause mortality compared with the prescription of ORT alone.
Design
Population-based cohort study.
Setting
Scotland, UK.
Participants
Participants were people prescribed ORT between January 2010 and end of December 2020 aged 18 years or above.
Main outcome measures
All-cause mortality, drug-related deaths and non-drug related deaths.
Secondary outcome
ORT continuous treatment duration.
Analysis
Cox regression with time-varying covariates.
Results
During follow-up, 5776 of 46 899 participants died: 1398 while on coprescription and 4378 while on ORT only. The mortality per 100 person years was 3.11 during coprescription and 2.34 on ORT only. The adjusted HR for all-cause mortality was 1.17 (1.10 to 1.24). The adjusted HR for drug-related death was 1.14 (95% CI, 1.04 to 1.24) and the hazard for death not classified as drug-related was 1.19 (95% CI, 1.09 to 1.30).
Conclusion
Coprescription of BZDs in ORT was associated with an increased risk of all-cause mortality, although with a small effect size than the international literature. Coprescribing was also associated with longer retention in treatment. Risk from BZD coprescription needs to be balanced against the risk from illicit BZDs and unplanned treatment discontinuation. A randomised controlled trial is urgently needed to provide a clear clinical direction.
Trial registration number
NCT04622995.
Objectives
This study aimed to evaluate the effectiveness of the Trauma Rating Index in Age, Glasgow Coma Scale, Respiratory rate and Systolic blood pressure score (TRIAGES) in predicting 24-hour in-hospital mortality among patients aged 65 years and older with isolated traumatic brain injury (TBI).
Design
A retrospective, single-centre cohort study.
Setting
This study was conducted at a government-run tertiary comprehensive hospital.
Participants
This study included 982 patients aged 65 years or older with isolated TBI, who were admitted to the emergency department between 1 January 2020 and 31 December 2021.
Interventions
None.
Primary outcome
24-hour in-hospital mortality was the primary outcome.
Results
Among the 982 patients, 8.75% died within 24 hours of admission. The non-survivors typically had higher TRIAGES and lower GCS scores. Logistic regression showed significant associations of both TRIAGES and GCS with mortality; the adjusted ORs were 1.98 (95% CI 1.74 to 2.25) for TRIAGES and 0.72 (95% CI 0.68 to 0.77) for GCS. Receiver operating characteristic (ROC) analysis indicated an area under the ROC curve of 0.86 for GCS and 0.88 for TRIAGES, with a significant difference (p=0.012). However, precision–recall curve (PRC) analysis revealed an area under the PRC of 0.38 for GCS and 0.47 for TRIAGES, without a significant difference (p=0.107).
Conclusions
The TRIAGES system is a promising tool for predicting 24-hour in-hospital mortality in older patients with TBI, demonstrating comparable or slightly superior efficacy to the GCS. Further multicentre studies are recommended for validation.
Objectives
This study aims to characterise oxycodone’s distribution and opioid-related overdoses in the USA by state from 2000 to 2021.
Design
This is an observational study.
Setting
More than 80 000 Americans died of an opioid overdose in 2021 as the USA continues to struggle with an opioid crisis. Prescription opioids play a substantial role, introducing patients to opioids and providing a supply of drugs that can be redirected to those seeking to misuse them.
Methods
The Drug Enforcement Administration annual summary reports from the Automation of Reports and Consolidated Orders System provided weights of oxycodone distributed per state by business type (pharmacies, hospitals and practitioners). Weights were converted to morphine milligram equivalents (MME) per capita and normalised for population. The Centers for Disease Control and Prevention Wide-ranging ONline Data for Epidemiologic Research provided mortality data for heroin, other opioids, methadone, other synthetic narcotics and other/unspecified narcotics.
Results
There was a sharp 280.13% increase in total MME/person of oxycodone from 2000 to 2010, followed by a slower 54.34% decrease from 2010 to 2021. Florida (2007–2011), Delaware (2003–2020) and Tennessee (2012–2021) displayed consistent and substantial elevations in combined MME/person compared with other states. In the peak year (2010), there was a 15-fold difference between the highest and lowest states. MME/person from only pharmacies, which constituted >94% of the total, showed similar results. Hospitals in Alaska (2000–2001, 2008, 2010–2021), Colorado (2008–2021) and DC (2000–2011) distributed substantially more MME/person over many years compared with other states. Florida stood out in practitioner-distributed oxycodone, with an elevation of almost 15-fold the average state from 2006 to 2010. Opioid-related deaths increased +806% from 2000 to 2021, largely driven by heroin, other opioids and other synthetic narcotics.
Conclusions
Oxycodone distribution across the USA showed marked differences between states and business types over time. Investigation of opioid policies in states of interest may provide insight for future actions to mitigate opioid misuse.
Objectives
Opioid-free anaesthesia (OFA) has emerged as a promising approach for mitigating the adverse effects associated with opioids. The objective of this study was to evaluate the impact of OFA on postoperative nausea and vomiting (PONV) following video-assisted thoracic surgery.
Design
Single-centre randomised controlled trial.
Setting
Tertiary hospital in Shanghai, China.
Participants
Patients undergoing video-assisted thoracic surgery were recruited from September 2021 to June 2022.
Intervention
Patients were randomly allocated to OFA or traditional general anaesthesia with a 1:1 allocation ratio.
Primary and secondary outcome measures
The primary outcome measure was the incidence of PONV within 48 hours post-surgery, and the secondary outcomes included PONV severity, postoperative pain, haemodynamic changes during anaesthesia, and length of stay (LOS) in the recovery ward and hospital.
Results
A total of 86 and 88 patients were included in the OFA and control groups, respectively. Two patients were excluded because of severe adverse events including extreme bradycardia and epilepsy-like convulsion. The incidence and severity of PONV did not significantly differ between the two groups (29 patients (33.0%) in the control group and 22 patients (25.6%) in the OFA group; relative risk 0.78, 95% CI 0.49 to 1.23; p=0.285). Notably, the OFA approach used was associated with an increase in heart rate (89±17 vs 77±15 beats/min, t-test: p
This cohort study examines whether there were changes in opioid prescribing and opioid-related health outcomes after implementation of British Columbia’s Safer Opioid Supply policy.
National practice groups and decades of research strongly support treating opioid use disorder (OUD) as a chronic illness and specifically call for the use of evidence-based medications to treat OUD throughout pregnancy and beyond. The criterion-standard medications for OUD (MOUD), including during pregnancy, are buprenorphine (approved by the US Food and Drug Administration in 2002) and methadone (approved by the US Food and Drug Administration to treat OUD in 1972). While evidence suggests that pregnancy may represent a specific window of opportunity to engage individuals in MOUD and that MOUD leads to better outcomes for the maternal-infant dyad, fewer than 1 in 4 individuals with OUD receive treatment in any given month of pregnancy.
During the ongoing opioid epidemic, it is crucial that pregnant people with opioid use disorder (OUD) receive accepted medical treatment with methadone or buprenorphine to prevent infections, overdose, and death in the pregnant person, as well as fetal death and neonatal opioid withdrawal syndrome. Internists and other primary care physicians have an important role to play in ensuring that pregnant persons receive appropriate treatment for OUD. In this issue of JAMA Internal Medicine, Suarez et al provide new information on the risk of major congenital abnormalities associated with use of methadone and buprenorphine during pregnancy. Given the importance of ensuring that pregnant people with OUD receive treatment during pregnancy and after birth, we have taken the unusual step of publishing 2 accompanying Invited Commentaries.
In this issue of JAMA Internal Medicine, Suarez et al studied a population-based cohort of publicly insured pregnant individuals receiving methadone or buprenorphine for opioid use disorder (OUD) in the US. Their study adds considerably to the sparse literature on rates of congenital malformations among newborns with in utero exposure to buprenorphine and methadone. The authors found a 1% absolute risk reduction of congenital malformations from buprenorphine exposure compared with methadone. First-trimester exposure to methadone was associated with higher odds of cardiac malformations, oral clefts, and clubfoot than buprenorphine. In secondary analyses, they found that buprenorphine exposure was associated with higher odds of gastrointestinal-specific malformation, mostly pyloric stenosis.
Introduction
In opioid therapy for cancer pain, opioid-induced nausea and vomiting (OINV) occur in 20%–40% of patients during initial opioid treatment or increasing opioid doses. OINV result in failure to achieve pain relief due to poor opioid adherence. Therefore, antiemetics are used to prevent OINV, but their efficacy and safety in this context have not yet been fully elucidated. Olanzapine is a promising antiemetic for the prophylaxis of chemotherapy-induced nausea and vomiting.
Methods and analysis
This single-arm, single-centre exploratory study will evaluate the prophylactic antiemetic efficacy and safety of 5 mg olanzapine in patients with cancer pain who are withholding initial regular opioid therapy. Thirty-five patients will be enrolled. The primary endpoint is the proportion of patients achieving complete control (CC) of OINV during 5 days of opioid treatment. CC was defined as the absence of emetic episodes, no need for rescue medication to treat nausea, and minimal or no nausea (3 or less on an 11-point categorical scale). Secondary endpoints include the complete response, defined as no emetic episodes and no use of rescue medication during the overall assessment period, the time from opioid initiation to first emetic episode, the time from opioid initiation to first rescue antiemetic administration, and adverse events graded by Patient-Reported Outcome (PRO) Common Terminology Criteria for Adverse Events (CTCAE) version 1.0 and CTCAE version 5.0.
Ethics and dissemination
This study protocol was approved by National Cancer Center Hospital Certified Review Board. The results will be used as preliminary data to conduct a validation study.
Trial registration number
Japan Registry of Clinical Trials (jRCT) jRCTs031220008.
Opioid exposure is associated with risk for serious falls in all age groups, but the oldest patients have the most risk.
