Standard vs. intensified management of heart failure to reduce healthcare costs: results of a multicentre, randomized controlled trial.

AIMS: To determine if an intensified form of heart failure management programme (INT-HF-MP) based on individual profiling is superior to standard management (SM) in reducing health care costs during 12-month follow-up (primary endpoint). METHODS AND RESULTS: A multicentre randomized trial involving 787 patients (full analysis set) discharged from four tertiary hospitals with chronic HF who were randomized to SM (n = 391) or INT-HF-MP (n = 396). Mean age was 74 ± 12 years, 65% had HF with a reduced ejection fraction (31.4 ± 8.9%) and 14% were remote-dwelling. Study groups were well matched. According to Green, Amber, Red Delineation of rIsk And Need in HF (GARDIAN-HF) profiling, regardless of location, patients in the INT-HF-MP received a combination of face-to-face (home visits) and structured telephone support (STS); only 9% (`low risk') were designated to receive the same level of management as the SM group. The median cost in 2017 Australian dollars (A$1 equivalent to ∼EUR €0.7) of applying INT-HF-MP was significantly greater than SM ($152 vs. $121 per patient per month; P < 0.001), However, at 12 months, there was no difference in total health care costs for the INT-HF-MP vs. SM group (median $1579, IQR $644 to $3717 vs. $1450, IQR $564 to $3615 per patient per month, respectively). This reflected minimal differences in all-cause mortality (17.7% vs. 18.4%; P = 0.848) and recurrent hospital stay (18.6 ± 26.5 vs. 16.6 ± 24.8 days; P = 0.199) between the INT-HF-MP and SM groups, respectively. CONCLUSION: During 12-months follow-up, an INT-HF-MP did not reduce healthcare costs or improve health outcomes relative to SM.

Ethical intensive care research: development of an ethics handbook.

Conduct of research involving humans in the intensive care unit (ICU) setting is complex and challenging. The vulnerable nature of critically ill patients raises issues of patient safety, and informed consent is difficult. With an increasing global interest in human research ethics, broadened government mandates have targeted improvements in research participant protection and research governance. A parallel rise in health consumerism and advocacy for privacy and protection of personal health information requires a clear understanding of the research participant role and importance of risk disclosure. In addition, the potential for conflicts of interest in a climate of increasingly competitive research funding, requires caution and transparency in related financial and contractual arrangements. The Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) fosters collaborative ICU research activity. We have developed An Ethics Handbook for Researchers (EH) for the ANZICS CTG for intended use by researchers in Australian and New Zealand ICUs. The purpose of the EH is to act as a practical advisory guide/supplement; to add clarification regarding ethical issues specific to intensive care research, to assist in the expedition of ethics committee research submission and to summarise available useful resources. This article introduces a précis of key issues from the EH including specific ethical difficulties pertaining to ICU research, a summary of the process by which ethics committee decisions in Australia and New Zealand are informed, and the use of ethical checklists to assist researchers.