Theories behind Bacillus Calmette-Guérin failure in high-risk non-muscle-invasive bladder cancer and update on current management.

Bladder cancer encapsulates a wide spectrum of disease severities, with non-muscle invasive bladder cancer (NMIBC) representing an entirely different entity from muscle-invasive disease. Bacillus Calmette-Guérin (BCG) is one of the most successful intravesical treatment methods for patients diagnosed. However, a considerable proportion of patients fail to respond to BCG treatment. Given the propensity for recurrence in patients with high-risk bladder cancer, these patients present with surgical dilemmas. There is currently no gold standard for salvage treatment post-BCG failure or unified definition as to what that means. In this review, we discuss the mechanisms of action and pathophysiology of BCG, potential theories behind BCG failure, and the scope of novel treatments for this surgical conundrum.

The Impact of Depression in Patients Undergoing Emergency Abdominal Surgery: An Exploratory Study.

BACKGROUND: Depression is associated with poorer outcomes in many disease states. However, its significance in abdominal surgery is unknown. This study investigated rates of depression in emergency abdominal surgery patients and its effects on outcomes. METHODS: A retrospective cohort study was conducted across two UK sites and included all adult patients undergoing emergency abdominal surgery. Primary outcome was the complication rate in depressed patients, including the incidence of post-operative delirium. Secondary outcomes included mortality, time to oral intake and analgesia. RESULTS: Two hundred and ten patients were identified. The commonest indication for surgery was appendicitis (53.3%) followed by small bowel obstruction (9.5%). There was a 17% (n = 36) incidence of depression amongst patients, most of whom (n = 26, 72.2%) were taking antidepressants. Depression was associated with male sex (M:F 27:9 p = 0.003), higher median BMI (28 vs. 25 p = 0.013) and previous surgery (47.2% vs. 28.7% p = 0.032). Despite a higher incidence of post-operative delirium, increased time to oral analgesia and greater 30-day readmission rates in the depression cohort, multivariate analyses showed depression was not a significant independent predictor of these (OR 2.181, 95%CI 0.310-15.344; p = 0.433, OR 0.07, 95%CI 0.499-1.408; p = 0.348 and OR 1.367, 95%CI 0.102-18.34, respectively). Complication and mortality rates between depressed and non-depressed individuals were similar. CONCLUSION: Significant numbers of patients undergoing emergency abdominal surgery have depression, but this did not adversely affect post-operative outcomes. The study included relatively small numbers of participants undergoing procedures with straightforward recovery. Larger population studies are therefore required and should focus on investigating the association between major emergency surgeries with post-operative delirium and uncontrolled pain.

E-Consent-a guide to maintain recruitment in clinical trials during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomized clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate, and patients' experience using e-Consent. METHODS: A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. Although e-Consent obviated the need for in-person meeting, there was nonetheless counselling sessions performed interactively online. This new pathway offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation. RESULTS: Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation. CONCLUSION: Remote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues. TRIAL REGISTRATION: NeuroSAFE PROOF trial NCT03317990 . Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978.