Utility-based optimization of Fujikawa's basket trial design - Pre-specified protocol of a comparison study.

Basket trial designs are a type of master protocol in which the same therapy is tested in several strata of the patient cohort. Many basket trial designs implement borrowing mechanisms. These allow sharing information between similar strata with the goal of increasing power in responsive strata while at the same time constraining type-I error inflation to a bearable threshold.

Laparoscopic Resection Rectopexy Versus Delorme's Procedure In Full-Thickness Rectal Prolapse - A Randomized Multicenter Trial (DELORES-RCT).

Objective: The DELORES trial investigated whether laparoscopic resection rectopexy (LRR) is superior to Delorme's procedure (DP) in full-thickness rectal prolapse.

Summary Of Background Data: Multiple perineal and transabdominal procedures are current practice for rectal prolapse surgery. Evidence from adequately designed randomized studies addressing the question of which of these procedures are superior in terms of recurrence and bowel function is lacking.

Complex, low-intensity, individualised naturalistic developmental behavioural intervention in toddlers and pre-schoolers with autism spectrum disorder: The multicentre, observer-blind, parallel-group randomised-controlled A-FFIP trial.

Background: Naturalistic developmental behavioural interventions (NDBI) may improve social communication in toddlers/pre-school aged children with autism spectrum disorder (ASD). Here, we study efficacy of the low-intensity, complex NDBI 'Frankfurt Early Intervention Program for ASD' (A-FFIP) over 1 year by a confirmatory phase-III, prospective, randomised, controlled, parallel-group study with two treatment arms over four centres.

Methods: Main inclusion criteria: ASD (DSM-5), age 24-66 months, developmental quotient >30.

Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer: results of a randomised controlled multicentre pilot trial (DRKS00013997).

Purpose: The objective of the current pilot trial was to evaluate whether ghost ileostomy is a safe alternative to the current standard of care in terms of a conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision (LAR/TME) for rectal cancer.

Methods: This randomized controlled pilot trial included patients undergoing LAR/TME, randomly assigning them to ghost ileostomy or conventional loop ileostomy intraoperatively. Follow-up spanned 6 months, evaluating the following endpoints: comprehensive complication index (CCI), postoperative morbidity, transformation of ghost ileostomy, presence of ostomy at 6 months, Wexner score, and quality of life (EORTC QLQ-C30 & CR29).

Association of intraprocedural near admission-level blood pressure with functional outcome in stroke patients treated with mechanical thrombectomy.

Background: Optimal blood pressure management during endovascular stroke treatment is not certain. We hypothesized that time or proportion of intraprocedural systolic blood pressure spent in a range around admission blood pressure might be associated with better clinical outcome.

Methods: We conducted a retrospective observational study at a single center at a university hospital, which included patients from August 2018 to September 2020 suffering from acute ischemic stroke with anterior circulation vessel occlusion and treated with endovascular therapy.

Assessing the hierarchical beta-binomial model as a basic information sharing tool in basket trials.

The majority of statistical methods to share information in basket trials are based on a Bayesian hierarchical model with a common normal distribution for the logit-transformed response rates. The methods are of varying complexity, yet they all use this basic model. Generally, complexity is an obstacle for the application in clinical trials and that includes the use of the logit-transformation.

Oncologic treatment support via a dedicated mobile app: a prospective feasibility evaluation (OPTIMISE-1).

Background: Mobile health (mhealth) is gaining interest, with mobile devices and apps being ever more available among medical facilities and patients. However, in the field of radiation oncology, the medical benefits of mhealth apps are still underexplored. As an additional approach to patient care during radiotherapy, we designed a mobile treatment surveillance app based on patient-reported outcomes.

Pelvic Irradiation for Node-Positive Prostate Cancer After Prostatectomy: Long-Term Results of the Prospective PLATIN-4 and PLATIN-5 Trials.

Purpose: After radical prostatectomy (RP), adjuvant or salvage radiation treatment in node-positive prostate cancer is offered to prevent systemic disease. Prospective long-term survival and toxicity data on patients with radiation for nodal disease are still scarce. This study evaluates safety and feasibility of salvage radiation therapy to the pelvic lymph nodes in node-positive prostate cancer after RP.

Effect of Individualized Versus Standardized Blood Pressure Management During Endovascular Stroke Treatment on Clinical Outcome: A Randomized Clinical Trial.

Background: Optimal blood pressure (BP) management during endovascular stroke treatment is not well established. We studied whether an individualized approach for managing BP during endovascular stroke treatment gives a better clinical outcome than an approach with standardized systolic BP targets.

Methods: The INDIVIDUATE study (Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation) is a randomized clinical trial with a prospective randomized open blinded end point (PROBE) design.