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This cross-sectional study examines private equity–backed acquisitions of medical and radiation oncology clinics in the US from 2003 to 2022 using financial databases and publicly available data.
Introduction
The rapid evolution of the therapeutic landscape in oncology poses challenges to optimal treatment sequencing. Evidence for clinical decision-making is often limited to studies focused on treatment evaluation at a single decision point, with limited capability of identifying delayed effects of prior treatment decisions on the efficacy and feasibility of future treatments. There is a growing interest in dynamic treatment regimes (DTRs) evaluation as it provides guidance on treatment individualisation based on evolving treatment and patient characteristics. In this scoping review we aim to systematically map how and to what extent DTRs have been evaluated in clinical studies to generate evidence for clinical decision-making in oncology.
Methods and analysis
We will do a systematic literature search in MEDLINE (PubMed), Web of Science, Scopus and WHO international clinical trials registry platform to identify clinical studies (including protocols of ongoing studies), with either experimental or observational design, that aim to answer a clinical question and explore treatment sequencing issues in oncology using the concept of DTR. Data extraction will comprise information concerning cancer disease, clinical setting, treatments, tailoring variables, decision rules, decision points and outcomes, type of data, study design and statistical methods used for DTR evaluation. The review will be conducted according to Joanna Briggs Institute Reviewer’s manual for scoping reviews. No patients will be involved.
Ethics and dissemination
Ethics committee approval is not required as this scoping review will undertake secondary analysis of published literature. Results will be disseminated through a peer-reviewed scientific journal and presented in relevant conferences. This scoping review will provide a better understanding of the methods used to generate evidence on treatment sequencing in oncology and will contribute to the identification of knowledge and methodological gaps that should be addressed.
Introduction
Deep brain stimulation (DBS) implantation under general anaesthesia (GA) has been applied to patients with Parkinson’s disease (PD) with severe comorbidities or disabling off-medication symptoms. However, general anaesthetics may affect intraoperative microelectrode recording (MER) to varying degrees. At present, there are few studies on the effects of sedatives or general anaesthetics on multiunit activity characteristics performed by MER in patients with PD during DBS. Therefore, the effect of the choice of anaesthesia on MER remains unclear.
Methods/design
This is a prospective randomised controlled, non-inferiority study that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Patients undergoing elective bilateral subthalamic nucleus (STN)-DBS will be enrolled after careful screening for eligibility. One hundred and eighty-eight patients will be randomised to receive either conscious sedation (CS) or GA at a 1:1 ratio. The primary outcome is the proportion of high normalised root mean square (NRMS) recorded by the MER signal.
Ethics and dissemination
The study was approved by the Ethics Committee of Beijing Tiantan Hospital of Capital Medical University (KY2022-147-02). Negative study results will indicate that GA using desflurane has a non-inferior effect on MER during STN-DBS compared with CS. The results of this clinical trial will be presented at national or international conferences and submitted to a peer-reviewed journal.
Trial registration number
NCT05550714.
Objectives
Previous research highlighted that in the early 2000s a significant share of the Italian population used and paid out of pocket for private healthcare services even when they could potentially have received the same treatments from the National Health Service (NHS). The decrease in public investments in healthcare and the increase in health needs due to the population ageing may have modified the use of private health services and equity of access to the Italian NHS. This study aims to investigate the change in the prevalence of individuals who have fully paid out of pocket for accessing healthcare services in Italy between 2006 and 2019 and the main reasons behind this choice.
Design
Cross-sectional comparative study.
Participants and comparison
Two representative samples of the Italian population were collected in 2006 and 2019.
Outcome measures
Prevalence of access to fully paid out-of-pocket private health services; type of service of the last fully paid out-of-pocket access; main reasons for the last fully paid out-of-pocket access.
Results
We found an increase in the prevalence of people who declared having fully paid out of pocket at least one access to health services during their lifetime from 79.0% in 2006 to 91.9% in 2019 (adjusted OR 2.66; 95% CI 1.98 to 3.58). ‘To avoid waiting times’ was the main reason and it was significantly more frequent in 2019 compared with 2006 (adjusted OR 1.75; 95% CI 1.45 to 2.11).
Conclusions
This comparative study, conducted the year before the outbreak of the COVID-19 pandemic, highlighted an increase in the prevalence of Italian residents who have fully paid out of pocket for access to health services to overcome long waiting times. Our findings may indicate a reduced access and possible worsening of the equity of access to the public and universalistic Italian NHS between 2006 and 2019.
Objectives
As understanding of the pathogenesis and treatment strategies for osteoarthritis (OA) evolves, it is important to understand how patient factors are also changing. Our goal was to examine demographics and known risk factors of patients with OA over time.
Design
Open-cohort retrospective study using electronic health records.
Setting
Large US integrated health system with 7 hospitals, 2.6 million outpatient clinic visits and 97 300 hospital admissions annually in a mostly rural geographic region.
Participants
Adult patients with at least two encounters and a diagnosis of OA or OA-relevant surgery between 2001 and 2018. Because of geographic region, over 96% of participants were white/Caucasian.
Interventions
None.
Primary and secondary outcome measures
Descriptive statistics were used to examine age, sex, body mass index (BMI), Charlson Comorbidity Index, major comorbidities and OA-relevant prescribing over time.
Results
We identified 290 897 patients with OA. Prevalence of OA increased significantly from 6.7% to 33.5% and incidence increased 37% (from 3772 to 5142 new cases per 100 000 patients per year) (p
Introduction
Enhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy.
Methods and analysis
This open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1–4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events.
Ethics and dissemination
The French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications.
Trial registration number
NCT04985695.
New England Journal of Medicine, Ahead of Print.
We sincerely thank the 866 peer reviewers who completed manuscript reviews for JAMA Oncology in 2022.
Introduction
Brain injury is common following open heart valve surgery. Carbon dioxide insufflation (CDI) has been proposed to reduce the incidence of brain injury by reducing the number of air microemboli entering the bloodstream in surgery. The CO2 Study will evaluate the efficacy and safety of CDI in patients undergoing planned left-sided open heart valve surgery.
Methods and analysis
The CO2 Study is a multicentre, blinded, placebo-controlled, randomised controlled trial. Seven-hundred and four patients aged 50 years and over undergoing planned left-sided heart valve surgery will be recruited to the study, from at least eight UK National Health Service hospitals, and randomised in a 1:1 ratio to receive CDI or medical air insufflation (placebo) in addition to standard de-airing. Insufflation will be delivered at a flow rate of 5 L/min from before the initiation of cardiopulmonary bypass until 10 min after cardiopulmonary bypass weaning. Participants will be followed up until 3 months post-surgery. The primary outcome is acute ischaemic brain injury within 10 days post-surgery based on new brain lesions identified with diffusion-weighted MRI or clinical evidence of permanent brain injury according to the current definition of stroke.
Ethics and dissemination
The study was approved by the East Midlands–Nottingham 2 Research Ethics Committee in June 2020 and the Medicines and Healthcare products Regulatory Agency in May 2020. All participants will provide written informed consent prior to undertaking any study assessments. Consent will be obtained by the principal investigator or a delegated member of the research team who has been trained in the study and undergone Good Clinical Practice training. Results will be disseminated through peer-reviewed publications and presentations at national and international meetings. Study participants will be informed of results through study notifications and patient organisations.
Trial registration number
ISRCTN30671536.
Black, indigenous, and people of color were slightly less likely than white patients to get subspecialty care in that setting.
Introduction
Transradial access (TRA) has rapidly emerged as the preferred vascular access site for coronary angiography and percutaneous coronary intervention. Radial artery occlusion (RAO) remains as an important complication of TRA as it precludes future ipsilateral transradial procedures. While intraprocedural anticoagulation has been studied extensively, the definitive role of postprocedural anticoagulation has not yet been established.
Methods and analysis
The Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion trial is a multicentre, prospective, randomised, open-label, blinded-endpoint design study investigating the efficacy and safety of rivaroxaban to reduce the incidence of RAO. Eligible patients will undergo randomisation to receive either rivaroxaban 15 mg once daily for 7 days or to no additional postprocedural anticoagulation. Doppler ultrasound to assess radial artery patency will be performed at 30 days.
Ethics and dissemination
The study protocol has been approved by the Ottawa Health Science Network Research Ethics Board (approval number 20180319-01H). The study results will be disseminated via conference presentations and peer-reviewed publications.
Trial registration number
NCT03630055.
Objectives
To assess the awareness and predictors of seeing/hearing a drug alert in British Columbia (BC) and subsequent drug use behaviour after seeing/hearing an alert.
Methods
This study analysed the 2021 BC harm reduction client survey (HRCS)—a cross-sectional self-reported survey administered at harm reduction sites throughout the province and completed by participants using the services.
Results
In total, n=537 respondents participated and n=482 (89.8%) responded to the question asking if they saw/heard a drug alert. Of those, n=300 (62.2%) stated that they saw/heard a drug alert and almost half reported hearing from a friend or peer network; the majority (67.4%) reported altering their drug use behaviour to be safer after seeing/hearing a drug alert. The proportion of individuals who saw/heard a drug alert increased with each ascending age category. Among health authorities, there were significant differences in the odds of seeing/hearing an alert. In the past 6 months, the odds of participants who attended harm reduction sites a few times per month seeing/hearing an alert were 2.73 (95% CI: 1.17 to 6.52) times the odds of those who did not. Those who attended more frequently were less likely to report seeing/hearing a drug alert. The odds of those who witnessed an opioid-related overdose in the past 6 months seeing/hearing an alert were 1.96 (95% CI: 0.86 to 4.50) times the odds of those who had not.
Conclusion
We found that drug alerts were mostly disseminated through communication with friends or peers and that most participants altered their drug use behaviour after seeing/hearing a drug alert. Therefore, drug alerts can play a role in reducing harms from substance use and more work is needed to reach diverse populations, such as younger people, those in differing geographical locations, and those who attend harm reduction sites more frequently.
Despite numerous advances in perioperative care, surgical site infection (SSI) remains a frequent complication after major abdominal surgery, with gastrointestinal procedures among the highest risk for infection. Besides the increased length of stay and overall costs of care, SSIs are the most common indication for readmission after surgery. Antimicrobial prophylaxis given during the perioperative period is an essential, evidence-based aspect of SSI prevention. The choice of prophylactic regimen in patients undergoing a surgical procedure should include an agent effective against the most likely infecting organisms.
Introduction
Psilocybin-assisted therapy has shown significant promise in treating the cluster of mood and anxiety symptoms that comprise post-traumatic stress disorder (PTSD) but has yet to be tested specifically in this condition. Furthermore, current pharmacological and psychotherapeutic treatments for PTSD are difficult to tolerate and limited in efficacy, especially in the US Military Veteran (USMV) population. This open-label pilot study will examine the safety and efficacy of two psilocybin administration sessions (15 mg and 25 mg), combined with psychotherapy, among USMVs with severe, treatment resistant PTSD.
Methods and analysis
We will recruit 15 USMVs with severe, treatment resistant PTSD. Participants will receive one low dose (15 mg) and one moderate/high dose (25 mg) of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. The primary safety outcome will be the type, severity and frequency of adverse events and suicidal ideation/behaviour, as measured by the Columbia Suicide Severity Rating Scale. The primary outcome measure for PTSD will be the Clinician Administered PTSD Scale-5. The primary endpoint will be 1 month following the second psilocybin administration session, and the total follow-up time will be 6 months.
Ethics and dissemination
All participants will be required to provide written informed consent. The trial has been authorised by the Ohio State University Institutional Review Board (study number: 2022H0280). Dissemination of results will occur via a peer-reviewed publication and other relevant media.
Trial registration number
NCT05554094.
Objectives
Areas with high sexually transmitted infection (STI) testing rates may not require additional strategies to improve testing. However, it may be necessary to intervene in areas with elevated STI risk, but with low STI testing rates. We aimed to compare STI-related risk profiles and STI testing rates by geographical area to determine areas for improvement of sexual healthcare access.
Design
Cross-sectional population-based study.
Setting
Greater Rotterdam area, the Netherlands (2015–2019).
Participants
All residents aged 15–45 years. Individual population-based register data were matched with laboratory-based STI testing data of general practitioners (GPs) and the only sexual health centre (SHC).
Outcome measures
Postal code (PC) area-specific STI risk scores (based on age, migratory background, education level and urbanisation), STI testing rates and STI positivity.
Results
The study area consists of approximately 500 000 residents aged 15–45 years. Strong spatial variation in STI testing, STI positivity and STI risk was observed. PC area testing rate ranged from 5.2 to 114.9 tests per 1000 residents. Three PC clusters were identified based on STI risk and testing rate: (1) high–high; (2) high–low; (3) low, independently of testing rate. Clusters 1 and 2 had comparable STI-related risk and STI positivity, but the testing rate differed greatly (75.8 vs 33.2 per 1000 residents). Multivariable logistic regression analysis with generalised estimating equation was used to compare residents in cluster 1 and cluster 2. Compared with cluster 1, residents in cluster 2 more often did not have a migratory background, lived in less urbanised areas with higher median household income, and more distant from both GP and SHC.
Conclusion
The determinants associated with individuals living in areas with high STI-related risk scores and low testing rates provide leads for improvement of sexual healthcare access. Opportunities for further exploration include GP education, community-based testing and service (re)allocation.
