clinically meaningful outcomes
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2022 ◽  
pp. 036354652110675
Author(s):  
Kyle N. Kunze ◽  
Evan M. Polce ◽  
Ian Michael Clapp ◽  
Thomas Alter ◽  
Shane J. Nho

Background: The International Hip Outcome Tool 12-Item Questionnaire (IHOT-12) has been proposed as a more appropriate outcome assessment for hip arthroscopy populations. The extent to which preoperative patient factors predict achieving clinically meaningful outcomes among patients undergoing hip arthroscopy for femoroacetabular impingement syndrome (FAIS) remains poorly understood. Purpose: To determine the predictive relationship of preoperative imaging, patient-reported outcome measures, and patient demographics with achievement of the minimal clinically important difference (MCID), Patient Acceptable Symptom State (PASS), and substantial clinical benefit (SCB) for the IHOT-12 at a minimum of 2 years postoperatively. Study Design: Case-control study; Level of evidence, 3. Methods: Data were analyzed for consecutive patients who underwent hip arthroscopy for FAIS between 2012 and 2018 and completed the IHOT-12 preoperatively and at a minimum of 2 years postoperatively. Fifteen novel machine learning algorithms were developed using 47 potential demographic, clinical, and radiographic predictors. Model performance was evaluated with discrimination, calibration, decision-curve analysis and the brier score. Results: A total of 859 patients were identified, with 685 (79.7%) achieving the MCID, 535 (62.3%) achieving the PASS, and 498 (58.0%) achieving the SCB. For predicting the MCID, discrimination for the best-performing models ranged from fair to excellent (area under the curve [AUC], 0.69-0.89), although calibration was excellent (calibration intercept and slopes: –0.06 to 0.02 and 0.24 to 0.85, respectively). For predicting the PASS, discrimination for the best-performing models ranged from fair to excellent (AUC, 0.63-0.81), with excellent calibration (calibration intercept and slopes: 0.03-0.18 and 0.52-0.90, respectively). For predicting the SCB, discrimination for the best-performing models ranged from fair to good (AUC, 0.61-0.77), with excellent calibration (calibration intercept and slopes: –0.08 to 0.00 and 0.56 to 1.02, respectively). Thematic predictors for failing to achieve the MCID, PASS, and SCB were presence of back pain, anxiety/depression, chronic symptom duration, preoperative hip injections, and increasing body mass index (BMI). Specifically, thresholds associated with lower likelihood to achieve a clinically meaningful outcome were preoperative Hip Outcome Score–Activities of Daily Living <55, preoperative Hip Outcome Score–Sports Subscale >55.6, preoperative IHOT-12 score ≥48.5, preoperative modified Harris Hip Score ≤51.7, age >41 years, BMI ≥27, and preoperative α angle >76.6°. Conclusion: We developed novel machine learning algorithms that leveraged preoperative demographic, clinical, and imaging-based features to reliably predict clinically meaningful improvement after hip arthroscopy for FAIS. Despite consistent improvements after hip arthroscopy, meaningful improvements are negatively influenced by greater BMI, back pain, chronic symptom duration, preoperative mental health, and use of hip corticosteroid injections.


2022 ◽  
pp. 1-4
Author(s):  
Timothy Daly ◽  
Ignacio Mastroleo ◽  
Vincent Henry ◽  
Mathieu Bourdenx

Two potential disease-modifying approaches for dementia are being vigorously tested: the early targeting of the neuropathology of Alzheimer’s disease (AD) and multi-domain lifestyle interventions to promote resilience to neuropathology. We apply the “web of information” model of clinical translation to both approaches to argue firstly that tests of treatments aiming to achieve clinically meaningful outcomes should remain simple, and secondly, that building clinically-meaningful treatments should be kept separate from public health policy which means promoting wide-reaching action against risk factors now with available information.


Author(s):  
Kaveh Hajifathalian ◽  
Donevan Westerveld ◽  
Alyson Kaplan ◽  
Enad Dawod ◽  
Andrea Herr ◽  
...  

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 347-348
Author(s):  
Jamie Justice

Abstract Efforts targeting biological aging pathways are advancing interventions which could extend healthy lifespan. Design of clinical trials to test such interventions necessitates an operational definition of healthspan, such as slowed accumulation or progression of multiple chronic diseases, functional decline, and disability. In this talk we explore these composite measures of healthspan proposed as outcomes for clinical trials in aging. This will be examined in example cases including multimorbidity and deficit accumulation frailty indices in an 8-Year intensive lifestyle intervention trial, and an update on multimordbity, functional, and biomarker endpoints in the trial Targeting Aging with MEtformin (TAME). Through these examples we will explore issues related to effect sizes and statistical challenges related to composite endpoints. Finally, we will discuss the role existing and emerging biomarkers of aging in clinical trials in geroscience and summarize evidence linking biomarkers to clinically meaningful outcomes.


2021 ◽  
Author(s):  
Lauren Beresford ◽  
Todd Norwood

BACKGROUND Digital physical therapy (DPT) programs deliver physical therapy (PT) via a mobile app to privately-insured employees as an employer-sponsored healthcare benefit. Although evidence shows that some DPT clinical outcomes are comparable to in-person care, no research examines how DPT delivers these outcomes. We evaluated a DPT program that delivered care through an app including initial video PT evaluations, follow-up video visits and in-app chat. Participants also accessed prescribed workouts, education and therapeutic activities assigned by their physical therapists (PTs) in the app. OBJECTIVE This study examined the correlates of “good” outcomes in DPT, defined as minimal clinically important differences (MCIDs) in pain and function as well as patient satisfaction. It then examined the effects of the strength of the patient-provider relationship and timely access to care on participation in DPT. METHODS We conducted an observational retrospective study of 814 pre and post surveyed DPT participants, 18 years and older, enrolled in DPT from February 2019 through December 2020 using generalized linear models. Binary variables defined participants with MCIDs in pain and function as the clinical outcomes. “Satisfied” participants had Net Promoter Scores of 9-10 on a final survey question capturing participants’ likelihood to recommend the program. Program participation included workouts per week and number of weeks in the program. RESULTS Clinically meaningful outcomes in DPT are directly affected by program participation. The odds participants had MCIDs in pain increased by 13% (p<0.01) for each additional weekly workout completed and the odds they had MCIDs in function increased by a factor of 1.04 (p<0.05) with each additional week in the program. Participant’s satisfaction was greater for those with significant changes in pain and function and more virtual visits. Participants with MCIDs in function and large changes in pain were approximately 1.85 (p<0.01) and 2.84 (p<0.0001) times more satisfied, respectively. Those with virtual visits beyond their initial evaluation were approximately 2-3 times (p<0.01) more satisfied. Direct access to and virtual visits with PTs were associated with great participation. Each additional PT-initiated message per week increased weekly workouts by 11% (p<0.0001). Virtual follow-up visits increased weekly workouts and weeks in the program by factors between 1 and 2. Access to a PT within 24 hours was associated with a 14% increase in workouts per week. CONCLUSIONS Program participation (program length and frequency of exercise) are associated with clinical outcomes in a DPT program. Satisfaction is affected by both virtual face-to-face visits and clinically meaningful changes in pain and function. Participation in DPT, which drives outcomes, is secured by strong relationships between PTs and patients as well as timely access to a PT.


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