Testosterone replacement in prostate cancer survivors with testosterone deficiency: Study protocol of a randomized controlled trial.

BACKGROUND: Most men diagnosed with prostate cancer today have organ-confined disease and low risk of disease recurrence after radical prostatectomy. Testosterone deficiency in prostate cancer survivors contributes to impaired health-related quality of life but testosterone treatment is viewed as a contraindication in this population. OBJECTIVES: We describe the design of the first randomized trial to determine the safety and efficacy of testosterone treatment in men who have undergone prostatectomy for non-aggressive prostate cancer and have symptomatic testosterone deficiency. METHODS: Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial is a randomized, placebo-controlled, double-blind, parallel group trial in 142 men, ≥ 40 years, who have undergone radical prostatectomy for organ-confined prostate cancer, Gleason score ≤ 7 (3+4), Stage pT2, N0, M0 lesions and have symptomatic testosterone deficiency and undetectable prostate specific antigen for > 2 years after surgery. Eligible participants are randomized to weekly intramuscular injections of 100-mg testosterone cypionate or placebo for 12 weeks and followed for another 12 weeks. Primary endpoint is change from baseline in sexual activity. Secondary outcomes include change in sexual desire, erectile function, energy, lean and fat mass, physical and cognitive performance. Safety is assessed by monitoring prostate-specific antigen, lower urinary tract symptoms, hemoglobin, and adverse events. RESULTS: The trial is being conducted at two trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No prostate-specific antigen or clinical recurrence has been noted to-date. DISCUSSION: Recruitment was slowed by coronavirus disease 2019-related closures, slow subsequent ramp-up of research activities, and patient concerns about safety of testosterone treatment. Despite these challenges, participant retention has been high. CONCLUSION: The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial, a placebo-controlled, randomized trial, will determine whether testosterone replacement therapy is safe and efficacious in correcting symptoms of testosterone deficiency in prostate cancer survivors, and potentially inform clinical practice.

Towards definitions of critical illness and critical care using concept analysis.

OBJECTIVE: As 'critical illness' and 'critical care' lack consensus definitions, this study aimed to explore how the concepts' are used, describe their defining attributes, and propose potential definitions. DESIGN AND METHODS: We used the Walker and Avant approach to concept analysis. The uses and definitions of the concepts were identified through a scoping review of the literature and an online survey of 114 global clinical experts. We used the Arksey and O'Malley framework for scoping reviews and searched in PubMed and Web of Science with a strategy including terms around critical illness/care and definitions/etymologies limited to publications in English between 1 January 2008 and 1 January 2020. The experts were selected through purposive sampling and snowballing, with 36.8% in Africa, 25.4% in Europe, 22.8% in North America, 10.5% in Asia, 2.6% in South America and 1.8% in Australia. They worked with anaesthesia or intensive care 59.1%, emergency care 15.8%, medicine 9.5%, paediatrics 5.5%, surgery 4.7%, obstetrics and gynaecology 1.6% and other specialties 3.9%. Through content analysis of the data, we extracted codes, categories and themes to determine the concepts' defining attributes and we proposed potential definitions. To assist understanding, we developed model, related and contrary cases concerning the concepts, we identified antecedents and consequences to the concepts, and defined empirical referents. RESULTS: Nine and 13 articles were included in the scoping reviews of critical illness and critical care, respectively. A total of 48 codes, 14 categories and 4 themes were identified in the uses and definitions of critical illness and 60 codes, 13 categories and 5 themes for critical care. The defining attributes of critical illness were a high risk of imminent death; vital organ dysfunction; requirement for care to avoid death; and potential reversibility. The defining attributes of critical care were the identification, monitoring and treatment of critical illness; vital organ support; initial and sustained care; any care of critical illness; and specialised human and physical resources. The defining attributes led to our proposed definitions of critical illness as, 'a state of ill health with vital organ dysfunction, a high risk of imminent death if care is not provided and the potential for reversibility', and of critical care as, 'the identification, monitoring and treatment of patients with critical illness through the initial and sustained support of vital organ functions.' CONCLUSION: The concepts critical illness and critical care lack consensus definitions and have varied uses. Through concept analysis of uses and definitions in the literature and among experts, we have identified the defining attributes of the concepts and proposed definitions that could aid clinical practice, research and policy-making.

Resilient performance in healthcare during the COVID-19 pandemic (ResCOV): study protocol for a multilevel grounded theory study on adaptations, working conditions, ethics and patient safety.

INTRODUCTION: Since early 2020, the COVID-19 pandemic has challenged societies and revealed the built-in fragility and dependencies in complex adaptive systems, such as healthcare. The pandemic has placed healthcare providers and systems under unprecedented amounts of strain with potential consequences that have not yet been fully elucidated. This multilevel project aims to explore resilient performance with the purpose of improving the understanding of how healthcare has adapted during the pandemic's rampage, the processes involved and the consequences on working conditions, ethics and patient safety. METHODS: An emerging explorative multilevel design based on grounded theory methodology is applied. Open and theoretical sampling is performed. Empirical data are gathered over time from written narratives and qualitative interviews with staff with different positions in healthcare organisations in two Swedish regions. The participants' first-person stories are complemented with data from the healthcare organisations' internal documents and national and international official documents. ANALYSIS: Experiences and expressions of resilient performance at different system levels and times, existing influencing risk and success factors at the microlevels, mesolevels and macrolevels and inter-relationships and consequences in different healthcare contexts, are explored using constant comparative analysis. Finally, the data are complemented with the current literature to develop a substantive theory of resilient performance during the pandemic. ETHICS AND DISSEMINATION: This project is ethically approved and recognises the ongoing strain on the healthcare system when gathering data. The ongoing pandemic provides unique possibilities to study system-wide adaptive capacity across different system levels and times, which can create an important basis for designing interventions focusing on preparedness to manage current and future challenges in healthcare. Feedback is provided to the settings to enable pressing improvements. The findings will also be disseminated through scientific journals and conferences.