Interpretable Trials: Is Interpretability a Reason Why Clinical Trials Fail?

There are clinical trials using composite measures, indices, or scales as proxy for independent variables or outcomes. Interpretability of derived measures may not be satisfying. Adopting indices of poor interpretability in clinical trials may lead to trial failure.

A proposal for a self-rated frailty index and status for patient-oriented research.

Objective: Frailty indices are important predictors of major health outcomes, but mostly designed by and for researchers and specialists. Three of the most commonly used theory-based indices are composite measures that are subject to arbitrary assumptions and biases introduced due to data processing. A complicated index can be simplified with fewer items.

Frailty measurement and outcomes in interventional studies: protocol for a systematic review of randomised control trials.

Introduction: Frailty is associated with reduced functional capacity, decreased resistance to stressors and is predictive of a range of adverse health outcomes, including dependency, hospitalisation and mortality. Early identification of frailty may prevent, reduce and postpone adverse health outcomes. However, there is a need for additional evidence to guide decision-making for the care of frail patients since frail persons are frequently excluded from studies, the differential impact of frailty is often not examined in clinical trials and few large-scale clinical trials examining frail cohorts have been conducted.

Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

Background: Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill.