Sample motion for reconsideration new evidence

Additionally, the quality of reporting across these studies is highly variable and often вЂњcharacterized by irrational exuberance and excessive hypeвЂќ. Depending on the technologyвЂ™s maturity, studies evaluating it may be conducted using a variety of study designs, data collection procedures, and analytic methodologies. Unfortunately, interpreting results from the current corpus of published work is challenging. To determine whether a digital measurement product вЂ“ or its component parts вЂ“ is fit-for-purpose for use by participants or patients in a research study or clinical care, decision makers must rely on published peer-reviewed literature or complete the evaluations themselves.

As described elsewhere, there are multiple factors that determine whether a remote monitoring tool can be considered fit for purpose in a stated context of use. Karger AG, BaselДigital measurement products are becoming increasingly prevalent for remote monitoring in clinical research and patient care.

With broad adoption, the EVIDENCE checklist will serve as a much-needed guide to raise the bar for quality reporting in published literature evaluating digital measurements products. Using EVIDENCE, those preparing, reading, or reviewing studies evaluating digital measurement products will be better equipped to distinguish necessary reporting requirements to drive high-quality research. EVIDENCE is applicable to 5 types of evaluations: (1) proof of concept (2) verification, (3) analytical validation, and (4) clinical validation as defined by the V3 framework and (5) utility and usability assessments. Here we use the terms digital measurement product and connected sensor technology interchangeably to refer to tools that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function. The aim of EVIDENCE is to promote high quality reporting in studies where the primary objective is an evaluation of a digital measurement product or its constituent parts. The EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist was developed by a multidisciplinary group of content experts convened by the Digital Medicine Society, representing the clinical sciences, data management, technology development, and biostatistics.

Sample motion for reconsideration new evidence