An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection.

Regulators increasingly require clinical outcome assessment (COA) data for approval. COAs can be collected via questionnaires or digital health technologies (DHTs), yet no single resource provides a side-by-side comparison of tools that collect complementary or related COA measures. We propose how to align ontologies for actively collected and passively monitored COAs into a single framework to allow for rapid, evidence-based, and fit-for-purpose measure selection.

One-Year Visual Outcomes and Corneal Higher-Order Aberration Assessment of Small-Incision Lenticule Extraction for the Treatment of Myopia and Myopic Astigmatism.

We present a retrospective, single-center report of one-year visual outcomes for Small Incision Lenticule Extraction (SMILE) to treat myopia and myopic astigmatism, as well as to compare outcomes with other published literature, including results from the United States Food and Drug Administration (US FDA). A total of 405 eyes with a mean preoperative spherical equivalent of -5.54 diopters (D) underwent SMILE between April 2017 and April 2022. The outcomes measured included visual acuity, manifest refraction, vector analysis, and wavefront aberrometry at various time points, specifically pre-operative and twelve months post-operatively. Results were compared to other similar published studies of SMILE outcomes between 2012 and 2021. A total of 308 and 213 eyes were evaluated at three and twelve months, respectively. At twelve months, 79% of eyes achieved UDVA ≥ 20/20, and 99% had ≥20/40, with no patients losing ≥2 lines of vision. For accuracy, 84% of eyes were within 0.5 D of target SEQ, and 97% were within 1 D. Total corneal higher order aberrations (HOA) increased from 0.33 to 0.61 um. Significant change was found in vertical coma and spherical aberration at twelve months. SMILE remains a safe and effective treatment for myopia and myopic astigmatism. Clinical outcomes are likely to improve with increased surgeon experience and refinement of technology and nomograms.

EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration.

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. 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. 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. 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. 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. 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.

Stiffness and proprioceptive contributions of ankle braces and the influence of localized muscle fatigue.

Ankle braces are a common treatment to reduce ankle sprain recurrence among individuals with chronic ankle instability (CAI). Bracing provides supplemental external joint stiffness and/or improved proprioceptive acuity. The goals of this study were to assess the effects of two ankle braces on joint position sense (JPS) and ankle stiffness, and determine whether bracing effects are reduced with localized muscle fatigue. Measures of JPS and ankle stiffness were obtained from participants with CAI (n=12) for three conditions (no brace, a neoprene wrap brace, and a semi-rigid brace), before and after inducing localized muscle fatigue at the ankle. Pre-fatigue JPS measures did not differ between brace conditions, but pre-fatigue stiffness was ∼0.8 and 2.5Nm/rad (∼5 and 14%) greater for the semi-rigid brace than the neoprene and no brace conditions, respectively. Fatigue increased absolute JPS errors by 0.3° (∼6 to 12%) across all conditions. Stiffness was unaffected by fatigue among females. Among males, fatigue increased stiffness by 0.75Nm/rad (∼3.3%) with the semi-rigid brace and decreased stiffness by 0.32Nm/rad (1.5%) with no brace. The semi-rigid brace may better protect males from sprains while either brace may be effective for females.

Localized Ankle Fatigue Development and Fatigue Perception in Adults With or Without Chronic Ankle Instability.

CONTEXT: Fatigue could contribute to ankle-sprain injuries during sport, particularly for individuals with chronic ankle instability (CAI). OBJECTIVE: To examine whether adults with or without CAI develop fatigue at similar rates when performing ankle exercises at the same relative effort level and whether these groups differ in their subjective perceptions of fatigue. DESIGN: Controlled laboratory study. SETTING: Biomechanics research laboratory. PATIENTS OR OTHER PARTICIPANTS: A total of 11 volunteers with CAI (1 man, 10 women; age = 23.5 ± 3.0 years, height = 168.0 ± 11.2 cm, mass = 64.3 ± 13.5 kg) were recruited for the unstable-ankle group, and 11 volunteers matched for age, height, mass, and sex (1 man, 10 women; age = 24.1 ± 2.1 years, height = 169.5 ± 9.7 cm, mass = 62.3 ± 9.7 kg) were recruited as control participants. INTERVENTION(S): Localized muscle fatigue (LMF) was induced in the ankle of the dominant limb using a custom fatigue protocol. Plantar-flexion and dorsiflexion exertions were completed at a rate of 12 cycles per minute at isotonic loads equal to 70% and 30%, respectively, of individual maximal voluntary isometric strength. Intermittent measures of maximal voluntary isometric strength and ratings of perceived exertion (RPEs) were obtained. MAIN OUTCOME MEASURE(S): We compared isometric-strength measures and RPE scores at each observation time (prefatigue and at 4, 8, 12, and 16 minutes into the fatigue protocol) and the group correlations between changes in strength and changes in RPE scores. RESULTS: Based on ankle-strength measures, the 2 test groups developed LMF at similar rates when exercising at equivalent levels of relative effort. The 2 groups also reported similar levels of discomfort as fatigue progressed. CONCLUSIONS: The rate of LMF development at the ankle and the associated perception of fatigue did not differ between adults with or without CAI.