Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma With UGN-101, a Mitomycin Reverse Thermal Gel.

Purpose: To evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract urothelial carcinoma.

Materials And Methods: Patients who participated in the OLYMPUS trial (TC-UT-03, NCT02793128) and achieved a complete response (CR) after 6-weekly doses of UGN-101 were followed up to 12 months after initial CR. Those with CR at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.

Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION).

Purpose: We evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer.

Materials And Methods: ENVISION is an ongoing, multinational, single-arm, phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months.

Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS).

Purpose: Low-grade intermediate-risk nonmuscle-invasive bladder cancer is a chronic illness commonly treated by repetitive transurethral resection of bladder tumor. We compared the efficacy and safety of intravesical chemoablation with UGN-102 (a reverse thermal gel containing mitomycin), with or without subsequent transurethral resection of bladder tumor, to transurethral resection of bladder tumor alone in patients with low-grade intermediate-risk nonmuscle-invasive bladder cancer.

Materials And Methods: This prospective, randomized, phase 3 trial recruited patients with new or recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer to receive initial treatment with either UGN-102 once weekly for 6 weeks or transurethral resection of bladder tumor.

Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial.

Purpose: Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary chemoablative therapeutic alternative to transurethral resection of bladder tumor for patients with LG IR NMIBC.

Materials And Methods: This prospective, phase 2b, open-label, single-arm trial recruited patients with biopsy-proven LG IR NMIBC to receive 6 once-weekly instillations of UGN-102.

Laparoscopic gynaecological surgery in the context of maintaining normal intracranial pressure.

A nulliparous patient in her early 20s was referred to a fertility specialist for fertility preservation, before commencing chemo-radiation therapy for a recently diagnosed malignant brain tumour. Two weeks prior, she had presented with seizures and undergone emergency craniotomy and tumour resection. Taking into consideration of the tight time frame and her comorbidities, several measures were undertaken to minimise the potential increase in intracranial pressure that may lead to cerebral oedema during laparoscopy.

Oral 5-Day Lefamulin for Outpatient Management of Community-Acquired Bacterial Pneumonia: Post-hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Trial.

Background: Safe and effective oral antibiotics are needed for outpatient management of moderate to severe community-acquired bacterial pneumonia (CABP).

Objective: We describe a post-hoc analysis of adults with CABP managed as outpatients from the Lefamulin Evaluation Against Pneumonia (LEAP) 2 double-blind, noninferiority, phase 3 clinical trial.

Methods: LEAP 2 compared the efficacy and safety of oral lefamulin 600 mg every 12 h (5 days) vs.

Behavior Change for Youth Drivers: Design and Development of a Smartphone-Based App (BackPocketDriver).

Background: The over-representation of youth in road crash injury and fatality rates is a major public health issue globally. In New Zealand, youth drivers are most vulnerable in the restricted license period when they can drive without the requirement for supervision by an experienced adult. Behavioral change interventions delivered using mobile phone technology to young drivers could serve as a useful mechanism to develop safe driving skills, but this potential remains to be fully explored.

Establishing the cost of implementing a performance-based, managed entry agreement for a hypothetical CAR T-cell therapy.

: Market access stakeholders consider the adoption of Managed Entry Agreements (MEAs), however a clearly described methodology to quantify their implementation burden is not available in the public domain. : To quantify the cost of implementing a performance-based MEA at the hospital level. : The analysis involved a hypothetical one-off therapy targeting Acute Lymphoblastic Leukaemia.

Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial.

Objective: Compare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD).

Methods: Participants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics.

Reducing hospital admissions for COPD: perspectives following the Christchurch Earthquake.

The devastating 2011 earthquake in Christchurch destroyed or badly damaged healthcare infrastructure, including Christchurch Hospital. This forced change in management of exacerbations of chronic obstructive pulmonary disease (COPD), which until that point had frequently led to admission to hospital and focused attention on providing safe community options for care. This paper describes the process of understanding factors contributing to high admission frequency with exacerbations of COPD and also describes a process of change, predominantly to healthcare delivery systems and philosophies, and the subsequent outcomes.

End Users Want Alternative Intervention Delivery Models: Usability and Acceptability of the REMOTE-CR Exercise-Based Cardiac Telerehabilitation Program.

Objective: Evaluate user experiences of an exercise-based cardiac telerehabilitation intervention (REMOTE-CR) that provided near universal access to real-time remote coaching and behavioral support from exercise specialists.

Design: Secondary analysis (12-week follow-up) of a parallel group, single blind, randomized controlled noninferiority trial (ACTRN12614000843651).

Setting: Community-based cardiac rehabilitation.

Remotely Delivered Exercise-Based Cardiac Rehabilitation: Design and Content Development of a Novel mHealth Platform.

Background: Participation in traditional center-based cardiac rehabilitation exercise programs (exCR) is limited by accessibility barriers. Mobile health (mHealth) technologies can overcome these barriers while preserving critical attributes of center-based exCR monitoring and coaching, but these opportunities have not yet been capitalized on.

Objective: We aimed to design and develop an evidence- and theory-based mHealth platform for remote delivery of exCR to any geographical location.

Supportive but "worried": perceptions of naturopaths, homeopaths and Chinese medicine practitioners through a regulatory transition in Ontario, Canada.

Background: In line with recent World Health Organization recommendations, many jurisdictions are taking steps to regulate practitioners of traditional, complementary and alternative medicine (TCAM). Previous studies have examined TCAM practitioners' generally-supportive views about professional regulation; however, little research has been conducted on TCAM practitioners' experiences and perspectives amidst an active regulatory process. In 2006 and 2007, the province of Ontario, Canada announced it would grant self-regulatory status to three TCAM practitioner groups--homeopaths, naturopaths and Chinese medicine practitioners/acupuncturists.

Skin surface temperature: a possible new outcome measure for skin and soft tissue infection.

Background: This study describes the novel use of skin surface temperature to measure the severity and the response to treatment of skin and soft tissue infection (SSTI).

Methods: Patients admitted with SSTI for intravenous antibiotic therapy. Skin temperature was measured daily at the point of maximum heat on the SSTI affected limb and the non-affected limb using a non-contact laser thermometer.

Safer laparoscopic trocar entry: it's all about pressure.

This prospective observational study aimed to assess the feasibility of adapting peritoneal hyperdistention to 25 mmHg during laparoscopy in an Australian hospital environment. A total of 1150 consecutive diagnostic or operative laparoscopies were performed. All cases were monitored for early detection of untoward physiological changes.

Morbidity associated with gastrostomy placement in children demands an ongoing integrated approach to care.

Aims: To evaluate the short and long term morbidity of gastrostomy insertion, and to identify ongoing management requirements.

Methods: A retrospective review was undertaken of the hospital casenotes of children aged up to fifteen years who had a gastrostomy placed in Christchurch over a six year period to March 1998.

Results: 42 children had a gastrostomy fashioned, 35 in the last three years of the period reviewed.

Combined epidural and general anaesthesia versus general anaesthesia for abdominal aortic surgery: a prospective randomised trial.

Fifty patients undergoing elective abdominal aortic surgery were randomised to receive either combined epidural and general anaesthesia and postoperative epidural analgesia (CEGA) or general anaesthesia and postoperative intravenous morphine infusion (GA). Prospective data was collected in order to compare the two groups. This included intraoperative cardiovascular changes and postoperative complications.

The United Kingdom: effective, efficient, equitable?

The British National Health Service (NHS) has, since its inception, aimed to make health care available to all regardless of income, and it has managed to achieve this goal while keeping costs lower as a proportion of the gross domestic product than many Western countries and at the same time assuring equitable distribution of resources regionally. Until the reforms introduced by the 1989 White Paper, the NHS was characterized by centralized financing and regulation; despite some problems in the delivery and management of care, the system was a popular one. The new reforms hope to enhance efficiency in the NHS by stimulating competition and further decentralizing the management of health care.

Carotid endarterectomy under cervical plexus block--a prospective clinical audit.

One hundred and twenty-eight patients having carotid endarterectomy under superficial and deep cervical plexus blocks were prospectively audited. The aim of the audit was to determine the incidence of intra-operative and postoperative neurological and cardiovascular complications and to establish patient acceptance of the technique. Twenty-seven patients who had intra-operative neurological changes following carotid artery clamping responded to shunt insertion.

Double-blind trial comparing epidural lignocaine with epidural fentanyl for anaesthesia during extracorporeal shock wave lithotripsy.

A randomised double-blind trial was undertaken to compare epidural lignocaine 1.5% with adrenaline to epidural fentanyl (100 micrograms in saline 10 ml) in forty unpremedicated patients undergoing extracorporeal shock wave lithotripsy without ancillary procedures. Midazolam only was used for sedation.