Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV).

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and flawed study design. Trials using cannabidiol-rich (CBD) products demonstrate improved efficacy and psychological adverse event profile. No definitive trials have been conducted to support the use of cannabinoids for this indication, nor has the potential economic impact of incorporating such regimens into the Australian healthcare system been established. CannabisCINV aims to assess the efficacy, safety and cost-effectiveness of adding TN-TC11M, an oral THC/CBD extract to guideline-consistent antiemetics in the secondary prevention of CINV. METHODS AND ANALYSIS: The current multicentre, 1:1 randomised cross-over, placebo-controlled pilot study will recruit 80 adult patients with any malignancy, experiencing CINV during moderate to highly emetogenic chemotherapy despite guideline-consistent antiemetics. Patients receive oral TN-TC11M (THC 2.5mg/CBD 2.5 mg) capsules or placebo capsules three times a day on day -1 to day 5 of cycle A of chemotherapy, followed by the alternative drug regimen during cycle B of chemotherapy and the preferred drug regimen during cycle C. The primary endpoint is the proportion of subjects attaining a complete response to CINV. Secondary and tertiary endpoints include regimen tolerability, impact on quality of life and health system resource use. The primary assessment tool is patient diaries, which are filled from day -1 to day 5. A subsequent randomised placebo-controlled parallel phase III trial will recruit a further 250 patients. ETHICS AND DISSEMINATION: The protocol was approved by ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences. DRUG SUPPLY: Tilray. PROTOCOL VERSION: 2.0, 9 June 2017. TRIAL REGISTRATION NUMBER: ANZCTR12616001036404; Pre-results.

Tabet v Gett: the end of loss of chance actions in Australia?

This article critically analyses the recent High Court decision in Tabet v Gett (2010) 84 ALJR 292; [2010] HCA 12 which considered whether a person should be able to obtain compensation on the basis of a loss of a chance of a better medical outcome. The appellant argued that the High Court should regard a plaintiff as entitled to compensation when a breach by a defendant of their duty of care causes the plaintiff to lose a possibility, but not a probability, of a better medical outcome. The High Court held that it was not possible for a person in the position of the appellant to obtain compensation for the loss of a chance of a better medical outcome.

The discipline of improvement: something old, something new?

In response to calls to improve the efficacy of health care services, there is an increasing focus on the processes of achieving a continuous improvement of services and practices. One specific response is that of the NHS Modernization Agency and National Health Service University in relation to the Discipline of Improvement in Health and Social Care. This paper draws on a study that explored the underpinning knowledge base of the Discipline of Improvement and focuses on describing the framework that was developed. The two-dimensional framework is composed of five primary categories, which cross-link to 11 competencies. The study concludes that the Discipline of Improvement draws together a group of ideas that together cohere to form a distinctive model to aid the improvement of health care. While some of these ideas are well-established, the way in which the Discipline of Improvement makes connections between them offers something new to our understanding of change in the complex world of health care provision, and to nursing management.

Management of a pregnant woman dependent on haemodialysis.

This is a case study of a woman who became pregnant whilst receiving haemodialysis in a London teaching hospital. She courageously disregarded the doctors' advise to abort the fetus. The doctors advised her to wait until she had a kidney transplant to become pregnant again, rather than increase maternal and fetal risk on dialysis. She was due to have a live-related transplant from her father in the spring. The case study describes a practical account in detailed measure to equip nurses with the knowledge to provide specialised care to high-risk dialysis expecting mothers. The main problems in this case study were trying to manage the mother's dialysis regime, control her anaemia, ensure good nutritional levels and gain accurate daily weights.