scholarly journals Within-subjects Effects of Standardized Prosthetic Socket Modifications on Physical Function and Patient-Reported Outcomes

2021 ◽  
Author(s):  
William Anderst ◽  
Goeran Fiedler ◽  
Kentaro Onishi ◽  
Gina McKernan ◽  
Tom Gale ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Design Method ◽  
Pressure Sensors ◽  
Residual Limb ◽  
Prosthetic Socket ◽  
Large Patient ◽  
Increased Risk ◽  
Patient Reported ◽  
And Function

Abstract • Background: Among the challenges of living with lower limb loss is the increased risk of long-term health problems that can be either attributed directly to the amputation surgery and/or prosthetic rehabilitation or indirectly to a disability-induced sedentary lifestyle. These problems are exacerbated by poorly fit prosthetic sockets. There is a knowledge gap regarding how the socket design affects in-socket mechanics, and how in-socket mechanics affect patient-reported comfort and function. The objectives of this study are: 1) to gain a better understanding of how in-socket mechanics of the residual limb in transfemoral amputees are related to patient-reported comfort and function, 2) to identify clinical tests that can streamline the socket design process, and 3) to evaluate the efficacy and cost of a novel, quantitatively informed socket optimization process.• Methods: Users of transfemoral prostheses will be asked to walk on a treadmill wearing their current socket plus 8 different check sockets with designed changes in different structural measurements that are likely to induce changes in residual limb motion, skin strain, and pressure distribution within the socket. Dynamic biplane radiography and pressure sensors will be used to measure in-socket residual limb mechanics. Patient-reported outcomes will also be collected after wearing each socket. The effects of in-socket mechanics on both physical function and patient-reported outcomes (aim 1) will be assessed using a generalized linear model. Partial correlation analysis will be used to examine the association between research grade measurements and readily available clinical measurements (aim 2). In order to compare the new quantitative design method to the Standard of Care, patient reported outcomes and cost will be compared between the two methods, utilizing the Wilcoxon Mann-Whitney non-parametric test (aim 3).• Discussion: Knowledge on how prosthetic socket modifications affect residual bone and skin biomechanics itself can be applied to devise future socket designs, and the methodology can be used to investigate and improve such designs, past and present. Apart from saving time and costs, this may result in better prosthetic socket fit for a large patient population, thus increasing their mobility, participation, and overall health-related quality of life. • Trial registration: clinicaltrials.gov: NCT05041998

scholarly journals Pain Assessment in Foot and Ankle Patients

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0006
Author(s):  
Meghan Kelly ◽  
David Bernstein ◽  
Ashlee MacDonald ◽  
John Ketz ◽  
Adolph Flemister ◽  
...  
Keyword(s):  
Pain Management ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Pearson Correlation ◽  
Pain Level ◽  
Foot And Ankle ◽  
Moderate Correlation ◽  
Patient Reported ◽  
And Function

Category: Other Introduction/Purpose: The ability to accurately quantify a patient’s pain pre-operatively is advantageous in the preparation of post-operative expectations and pain management. The Numeric Pain Rating Scale (NPRS) is a popular method to identify patient pain level. Other patient reported outcomes are being collected, such as the Patient Reported Outcomes Measurement Information System (PROMIS) and has been suggested to be more accurate in measuring pain as well as physical function. The aim of this study was to 1) determine whether NPRS or PROMIS Pain Interference (PI) demonstrates a stronger association with physical function as determined by PROMIS Physical Function (PF) and 2) to determine which method better predicts post-surgical pain in a population of elective surgical foot and ankle patients. Methods: Prospective PROMIS PF, PI and NPRS (0-10) data was obtained for common foot and ankle elective surgical procedures (CPT codes 27698, 27870, 28285, 28289, 28300, 28705, 28730, 28750) from a multi-surgeon foot and ankle clinic between February 2015 until November 2017. Pearson correlation coefficients were used to determine the relationship between NPRS (0-10) and PROMIS domains (PI, PF) pre and post-operatively. Correlations were considered high (> 0.7), high moderate (0.6-0.69), moderate (0.4-0.6) or weak (<0.4). Results: A total of 502 patients found to have complete data sets and > 6 month follow up were evaluated (74% women, mean age 54+/- SD, mean follow-up 14.4 months, range 6-34 months). Pearson correlation evaluation of NPRS and PI revealed a moderate correlation in the pre- and postoperative setting. There was a high moderate negative correlation between PI and PF t-scores pre and postoperatively suggesting more pain and less function. However, the negative correlation between NPRS and PF pre- and postoperatively was weak indicating a poor relationship between NPRS pain assessment and function. There was a moderate correlation between pre- and postoperative scores in all domains of PROMIS while the correlation between pre- and postoperative NPRS scores was weak. Conclusion: In a population of elective surgical foot and ankle patients, the use of both NPRS and PROMIS can be utilized to assess pain level, however the PROMIS PI domain demonstrated a stronger relationship with PROMIS PF than NPRS. Furthermore, only the PROMIS domains demonstrated at least a moderate correlation between pre- and post-operative scores. PROMIS PI provides superior assessment of pre- and post-operative physical function and prediction of post-operative pain. PROMIS PI can be used to gauge a patient’s pre-operative level of pain and function and aid the surgeon in guiding post-operative patient expectations and pain management.

scholarly journals Mental health, fatigue and function are associated with increased risk of disease flare following TNF inhibitor tapering in patients with rheumatoid arthritis: an exploratory analysis of data from the Optimizing TNF Tapering in RA (OPTTIRA) trial

RMD Open ◽  
2018 ◽  
Vol 4 (1) ◽  
pp. e000676 ◽  
Author(s):  
Katie Bechman ◽  
Fang En Sin ◽  
Fowzia Ibrahim ◽  
Sam Norton ◽  
Faith Matcham ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Mental Health ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Physical Component Score ◽  
Tnf Inhibitor ◽  
Increased Risk ◽  
Sf 36 ◽  
Patient Reported ◽  
And Function

BackgroundTapering of anti-tumour necrosis factor (TNF) therapy appears feasible, safe and effective in selected patients with rheumatoid arthritis (RA). Depression is highly prevalent in RA and may impact on flare incidence through various mechanisms. This study aims to investigate if psychological states predict flare in patients’ dose tapering their anti-TNF therapy.MethodsThis study is a post-hoc analysis of the Optimizing TNF Tapering in RA trial, a multicentre, randomised, open-label study investigating anti-TNF tapering in RA patients with sustained low disease activity. Patient-reported outcomes (Health Assessment Questionnaire, EuroQol 5-dimension scale, Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F), 36-Item Short Form Survey (SF-36)) were collected at baseline. The primary outcome was flare, defined as an increase in 28-joint count Disease Activity Score (DAS28) ≥0.6 and ≥1 swollen joint. Discrete-time survival models were used to identify patient-reported outcomes that predict flare.ResultsNinety-seven patients were randomised to taper their anti-TNF dose by either 33% or 66%. Forty-one patients flared. Higher baseline DAS28 score was associated with flare (adjusted HR 1.96 (95% CI 1.18 to 3.24), p=0.01). Disability (SF-36 physical component score), fatigue (FACIT-F) and mental health (SF-36 mental health subscale (MH)) predicted flare in unadjusted models. In multivariate analyses, only SF-36 MH remained a statistically significant predictor of flare (adjusted HR per 10 units 0.74 (95% CI 0.60 to 0.93), p=0.01).ConclusionsBaseline DAS28 and mental health status are independently associated with flare in patients who taper their anti-TNF therapy. Fatigue and function also associate with flare but the effect disappears when adjusting for confounders. Given these findings, mental health and functional status should be considered in anti-TNF tapering decisions in order to optimise the likelihood of success.Trial registration numbersEudraCT Number: 2010-020738-24; ISRCTN28955701; Post-results.

Impact of Preoperative Opioid Use on 2-Year Patient-Reported Outcomes in Knee Surgery Patients

2020 ◽  
Author(s):  
Ali Aneizi ◽  
Patrick M. J. Sajak ◽  
Aymen Alqazzaz ◽  
Tristan Weir ◽  
Cameran I. Burt ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Knee Surgery ◽  
The Body ◽  
Pain Interference ◽  
Opioid Use ◽  
Opioid Prescription ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Met Expectations

AbstractThe objectives of this study are to assess perioperative opioid use in patients undergoing knee surgery and to examine the relationship between preoperative opioid use and 2-year postoperative patient-reported outcomes (PROs). We hypothesized that preoperative opioid use and, more specifically, higher quantities of preoperative opioid use would be associated with worse PROs in knee surgery patients. We studied 192 patients undergoing knee surgery at a single urban institution. Patients completed multiple PRO measures preoperatively and 2-year postoperatively, including six patient-reported outcomes measurement information system (PROMIS) domains; the International Knee Documentation Committee (IKDC) questionnaire, numeric pain scale (NPS) scores for the operative knee and the rest of the body, Marx's knee activity rating scale, Tegner's activity scale, International Physical Activity Questionnaire, as well as measures of met expectations, overall improvement, and overall satisfaction. Total morphine equivalents (TMEs) were calculated from a regional prescription monitoring program. Eighty patients (41.7%) filled an opioid prescription preoperatively, and refill TMEs were significantly higher in this subpopulation. Opioid use was associated with unemployment, government insurance, smoking, depression, history of prior surgery, higher body mass index, greater comorbidities, and lower treatment expectations. Preoperative opioid use was associated with significantly worse 2-year scores on most PROs, including PROMIS physical function, pain interference, fatigue, social satisfaction, IKDC, NPS for the knee and rest of the body, and Marx's and Tegner's scales. There was a significant dose-dependent association between greater preoperative TMEs and worse scores for PROMIS physical function, pain interference, fatigue, social satisfaction, NPS body, and Marx's and Tegner's scales. Multivariable analysis confirmed that any preoperative opioid use, but not quantity of TMEs, was an independent predictor of worse 2-year scores for function, activity, and knee pain. Preoperative opioid use and TMEs were neither independent predictors of met expectations, satisfaction, patient-perceived improvement, nor improvement on any PROs. Our findings demonstrate that preoperative opioid use is associated with clinically relevant worse patient-reported knee function and pain after knee surgery.

scholarly journals Which patient-reported outcomes do rheumatology patients find important to track digitally? A real-world longitudinal study in ArthritisPower

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
W. Benjamin Nowell ◽  
Kelly Gavigan ◽  
Carol L. Kannowski ◽  
Zhihong Cai ◽  
Theresa Hunter ◽  
...  
Keyword(s):  
Physical Function ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Treatment Effectiveness ◽  
Time Window ◽  
Joint Stiffness ◽  
Summary Score ◽  
Longitudinal Tracking ◽  
Patient Reported

Abstract Background Patient-reported outcomes (PROs) are increasingly used to track symptoms and to assess disease activity, quality of life, and treatment effectiveness. It is therefore important to understand which PROs patients with rheumatic and musculoskeletal disease consider most important to track for disease management. Methods Adult US patients within the ArthritisPower registry with ankylosing spondylitis, fibromyalgia syndrome, osteoarthritis, osteoporosis, psoriatic arthritis, rheumatoid arthritis, and systemic lupus erythematosus were invited to select between 3 and 10 PRO symptom measures they felt were important to digitally track for their condition via the ArthritisPower app. Over the next 3 months, participants (pts) were given the option to continue tracking their previously selected measures or to remove/add measures at 3 subsequent monthly time points (month [m] 1, m2, m3). At m3, pts prioritized up to 5 measures. Measures were rank-ordered, summed, and weighted based on pts rating to produce a summary score for each PRO measure. Results Among pts who completed initial selection of PRO assessments at baseline (N = 253), 140 pts confirmed or changed PRO selections across m1–3 within the specified monthly time window (28 days ± 7). PROs ranked as most important for tracking were PROMIS Fatigue, Physical Function, Pain Intensity, Pain Interference, Duration of Morning Joint Stiffness, and Sleep Disturbance. Patient’s preferences regarding the importance of these PROs were stable over time. Conclusion The symptoms that rheumatology patients prioritized for longitudinal tracking using a smartphone app were fatigue, physical function, pain, and morning joint stiffness.

scholarly journals FRI0048 NUMBER NEEDED TO TREAT TO ACHIEVE MINIMUM CLINICALLY SIGNIFICANT DIFFERENCES IN PATIENT-REPORTED OUTCOMES IN PATIENTS TREATED WITH BARICITINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bodily Pain ◽  
Health Assessment ◽  
Number Needed To Treat ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

Patient-reported outcomes across cerebrovascular event types

Neurology ◽  
2018 ◽  
Vol 91 (23) ◽  
pp. e2182-e2191 ◽  
Author(s):  
Irene L. Katzan ◽  
Andrew Schuster ◽  
Christopher Newey ◽  
Ken Uchino ◽  
Brittany Lapin
Keyword(s):  
Ischemic Stroke ◽  
Executive Function ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Social Roles ◽  
Factors Associated ◽  
Cerebrovascular Events ◽  
Patient Reported ◽  
Health Domains ◽  
Domain Scores

ObjectivesTo compare the degrees to which 8 domains of health are affected across types of cerebrovascular events and to identify factors associated with domain scores in different event types.MethodsThis was an observational cohort study of 2,181 patients with ischemic stroke, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or TIA in a cerebrovascular clinic from February 17, 2015, to June 2, 2017 who completed Quality of Life in Neurologic Disorders executive function and the following Patient-Reported Outcomes Measurement Information System scales as part of routine care: physical function, satisfaction with social roles, fatigue, anxiety, depression, pain interference, and sleep disturbance.ResultsAll health domains were affected to similar degrees in patients with ICH, SAH, and ischemic stroke after adjustment for disability and other clinical factors, whereas patients with TIA had worse adjusted scores for 5 of the 8 domains of health. Female sex, younger age, lower income, and event <90 days were associated with worse scores in multiple domains. Factors associated with health domain scores were similar for all cerebrovascular events. Most affected domains for all were physical function, satisfaction with social roles, and executive function.ConclusionsThe subtype of stroke (ischemic stroke, ICH, and SAH) had similar effects in multiple health domains, while patients with TIA had worse adjusted outcomes, suggesting that the mechanisms for outcomes after TIA may differ from those of other cerebrovascular events. The most affected domains across all event types were physical function, satisfaction with social roles, and executive function, highlighting the need to develop effective interventions to improve these health domains in survivors of these cerebrovascular events.

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