Converting ODI or SF-36 Physical Function Domain Scores to a PROMIS PF Score

Context: To our knowledge, no authors have assessed health-related quality of life (HR-QOL) in participants with functional ankle instability (FAI). Furthermore, the relationships between measures of ankle functional limitation and HR-QOL are unknown. Objective: To use the Short Form–36v2 Health Survey (SF-36) to compare HR-QOL in participants with or without FAI and to determine whether HR-QOL was related to functional limitation. Design: Cross-sectional study. Setting: Sports medicine research laboratory. Patients or Other Participants: Sixty-eight participants with FAI (defined as at least 1 lateral ankle sprain and 1 episode of giveway per month) or without FAI were recruited (FAI group: n = 34, age = 25 ± 5 years, height = 1.71 ± 0.08 m, mass = 74.39 ± 12.78 kg, Cumberland Ankle Instability Tool score = 19.3 ± 4; uninjured [UI] group: n = 34, age = 23 ± 4 years, height = 1.69 ± 0.08 m, mass = 67.94 ± 11.27 kg, Cumberland Ankle Instability Tool score = 29.4 ± 1). Main Outcome Measure(s): All participants completed the SF-36 as a measure of HR-QOL and the Foot and Ankle Ability Measure (FAAM) and the FAAM Sport version (FAAMS) as assessments of functional limitation. To compare the FAI and UI groups, we calculated multiple analyses of variance followed by univariate tests. Additionally, we correlated the SF-36 summary component scale and domain scales with the FAAM and FAAMS scores. Results: Participants with FAI had lower scores on the SF-36 physical component summary (FAI = 54.4 ± 5.1, UI = 57.8 ± 3.7, P = .005), physical function domain scale (FAI = 54.5 ± 3.8, UI = 56.6 ± 1.2, P = .004), and bodily pain domain scale (FAI = 52.0 ± 6.7, UI = 58.5 ± 5.3, P < .005). Similarly, participants with FAI had lower scores on the FAAM (FAI = 93.7 ± 8.4, UI = 99.5 ± 1.4, P < .005) and FAAMS (FAI = 84.5 ± 8.4, UI = 99.8 ± 0.72, P < .005) than did the UI group. The FAAM score was correlated with the physical component summary scale (r = 0.42, P = .001) and the physical function domain scale (r = 0.61, P < .005). The FAAMS score was correlated with the physical function domain scale (r = 0.47, P < .005) and the vitality domain scale (r = 0.36, P = .002). Conclusions: Compared with UI participants, those with FAI had less HR-QOL and more functional limitations. Furthermore, positive correlations were found between HR-QOL and functional limitation measures. This suggests that ankle impairment may reduce overall HR-QOL.

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PROMIS PF CAT Outperforms the ODI and SF-36 Physical Function Domain in Spine Patients

Spine ◽

10.1097/brs.0000000000001965 ◽

2017 ◽

Vol 42 (12) ◽

pp. 921-929 ◽

Cited By ~ 73

Author(s):

Darrel S. Brodke ◽

Vadim Goz ◽

Maren W. Voss ◽

Brandon D. Lawrence ◽

William Ryan Spiker ◽

...

Keyword(s):

Physical Function ◽

Sf 36 ◽

Function Domain

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1440 ◽

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

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Impact of kinesiophobia on physical function and quality of life in functional ankle instability individuals: an observational study

Bulletin of Faculty of Physical Therapy ◽

10.1186/s43161-021-00032-0 ◽

2021 ◽

Vol 26 (1) ◽

Author(s):

Prachita P. Walankar ◽

Vrushali P. Panhale ◽

Kanchi M. Vyas

Keyword(s):

Quality Of Life ◽

Physical Function ◽

Negative Correlation ◽

Ankle Instability ◽

Cross Sectional Study ◽

Functional Ankle Instability ◽

Cross Sectional ◽

Sf 36 ◽

Related Quality

Abstract Background Functional ankle instability is a common musculoskeletal condition affecting the community. It is characterized by repetitive bouts of giving away, recurrent sprains, and sensation of instability leading to functional deficits in an individual. The present study aimed to assess the influence of kinesiophobia on physical function and quality of life in participants with functional ankle instability. A cross-sectional study was conducted in 30 participants with functional ankle instability. Kinesiophobia was assessed using the 17-item Tampa Scale of Kinesiophobia, physical function using the Foot and Ankle Ability Measure (FAAM) and the FAAM-Sport version (FAAM-S), and quality of life using SF-36. Results The TSK score showed a moderate negative correlation with FAAM-S (r = −0.5, p = 0.005) and a weak negative correlation with SF-36 physical component summary (r = −0.42, p = 0.02). However, TSK showed no significant correlation with FAAM-ADL and SF-36 mental component summary. Conclusion Increased fear of movement, reduced physical function, and health-related quality of life were observed in functional ankle instability individuals. Hence, evaluation of these parameters is imperative in these individuals.

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AB0814 SUSTAINED IMPROVEMENTS IN PHYSICAL FUNCTION, QUALITY OF LIFE, AND WORK PRODUCTIVITY WITH IXEKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND PREVIOUS INADEQUATE RESPONSE TO TUMOUR NECROSIS FACTOR-INHIBITORS: 3-YEAR RESULTS FROM SPIRIT-P2 TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2087 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1709-1710

Author(s):

A. M. Orbai ◽

J. Gratacos-Masmitja ◽

E. Dokoupilova ◽

B. Combe ◽

A. Constantin ◽

...

Keyword(s):

Quality Of Life ◽

Physical Function ◽

Work Productivity ◽

Inadequate Response ◽

Research Support ◽

Activity Impairment ◽

Sf 36 ◽

Intent To Treat ◽

Treat Population

Background:Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets IL-17A, has shown improvements compared to placebo (PBO) not only in disease activity but also in various patient-reported outcomes (PROs) assessing physical function, quality of life (QoL), and work productivity in PsA patients treated for 24 weeks and sustained up to 52 weeks.1, 2Objectives:To report the effects of treatment with IXE on these PROs after up to 3 years of treatment.Methods:In SPIRIT-P2 (NCT02349295), a Phase 3 trial, 363 adult patients with active PsA and prior inadequate response or intolerance to 1 or 2 TNF inhibitors (TNFis) were randomized 1:1:1 to IXE 80 mg every 4 weeks (IXEQ4W; N=122) or every 2 weeks (IXEQ2W; N=123), or PBO (N=118) in the double-blind treatment period (Weeks 0-24). Both IXE regimens had a starting dose of 160 mg. Results are reported from a subset of the intent-to-treat population who were randomized to IXE at baseline (Week 0). The following PROs were assessed during Weeks 0-156: HAQ-DI (minimally clinically important difference [MCID] an improvement ≥0.35), medical outcomes survey Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS), European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D VAS), and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP; absenteeism, presenteeism, work productivity, and activity impairment). Missing values were imputed by observed analysis and modified baseline observation carried forward (mBOCF) for continuous data or by modified non-responder imputation (mNRI) for categorical data.Results:Mean baseline scores for SF-36 (PCS and MCS), EQ-5D VAS, and WPAI-SHP (Figure 1) and HAQ-DI (mean [SD]: IXEQ4W=1.2 [0.6]; IXEQ2W=1.2 [0.6]), indicated impaired physical function and QoL. The percentage of patients of who completed 156 weeks of the study in IXEQ4W and IXEQ2W arms were 57.4% (n=70) and 44.7% (n=55), respectively. Patients receiving IXE treatment up to 3 years reported sustained improvements in SF-36 (PCS and MCS), EQ-5D VAS, and WPAI-SHP (presenteeism, work productivity, and activity impairment) (Figure 1). Observed HAQ-DI mean change from baseline in IXEQ4W: -0.46 (0.62) and IXEQ2W: -0.48 (0.55). The percentage of IXE treated patients achieving MCID for HAQ-DI (improvement ≥0.35) was sustained at 3 years (Figure 2).Figure 1.Summary of Patient-Reported Outcomes presented as change from baseline at Week 156 (Observed and mBOCF): Intent-to-Treat Population (Patients Randomized to IXE at Baseline)Figure 2.Patients achieving HAQ-DI MCID Response up to Week 156 (Observed) and at Week 156 (mNRI) among patients with HAQ-DI≥0.35 at baseline: Intent-to-Treat Population (Patients Randomized to IXE at Baseline)Conclusion:Improvements in PROs, measuring physical and mental function, quality of life, and work productivity are maintained up to 3 years with IXE treatment in patients with active PsA who have had an inadequate response or intolerance to 1 or 2 TNFis.References:[1]Nash P, et al. Lancet. 2017;389(10086):2317-2327.[2]Genovese MC, et al. Rheumatology (Oxford). 2018;57(11):2001-2011.Disclosure of Interests:Ana-Maria Orbai Grant/research support from: Abbvie, Eli Lilly and Company, Celgene, Novartis, Janssen, Horizon, Consultant of: Eli Lilly; Janssen; Novartis; Pfizer; UCB. Ana-Maria Orbai was a private consultant or advisor for Sun Pharmaceutical Industries, Inc, not in her capacity as a Johns Hopkins faculty member and was not compensated for this service., Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Eva Dokoupilova Grant/research support from: Eli Lilly and Abbvie, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Amanda M. Gellett Shareholder of: Eli Lilly and company, Employee of: Eli Lilly and company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Julie Birt Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB

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Patient-reported outcomes across cerebrovascular event types

Neurology ◽

10.1212/wnl.0000000000006626 ◽

2018 ◽

Vol 91 (23) ◽

pp. e2182-e2191 ◽

Cited By ~ 10

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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Associations Between Heart Rate Variability Measured With a Wrist-Worn Sensor and Older Adults’ Physical Function: Observational Study

JMIR mhealth and uhealth ◽

10.2196/13757 ◽

2019 ◽

Vol 7 (10) ◽

pp. e13757 ◽

Cited By ~ 3

Author(s):

Sarah Anne Graham ◽

Dilip V Jeste ◽

Ellen E Lee ◽

Tsung-Chin Wu ◽

Xin Tu ◽

...

Keyword(s):

Older Adults ◽

Heart Rate ◽

Heart Rate Variability ◽

Health Status ◽

Physical Health ◽

Physical Function ◽

Significant Proportion ◽

Physical Health Status ◽

Sf 36 ◽

Composite Scores

Background Heart rate variability (HRV), or variation in beat-to-beat intervals of the heart, is a quantitative measure of autonomic regulation of the cardiovascular system. Low HRV derived from electrocardiogram (ECG) recordings is reported to be related to physical frailty in older adults. Recent advances in wearable technology offer opportunities to more easily integrate monitoring of HRV into regular clinical geriatric health assessments. However, signals obtained from ECG versus wearable photoplethysmography (PPG) devices are different, and a critical first step preceding their widespread use is to determine whether HRV metrics derived from PPG devices also relate to older adults’ physical function. Objective This study aimed to investigate associations between HRV measured with a wrist-worn PPG device, the Empatica E4 sensor, and validated clinical measures of both objective and self-reported physical function in a cohort of older adults living independently within a continuing care senior housing community. Our primary hypothesis was that lower HRV would be associated with lower physical function. In addition, we expected that HRV would explain a significant proportion of variance in measures of physical health status. Methods We evaluated 77 participants from an ongoing study of older adults aged between 65 and 95 years. The assessments encompassed a thorough examination of domains typically included in a geriatric health evaluation. We collected HRV data with the Empatica E4 device and examined bivariate correlations between HRV quantified with the triangular index (HRV TI) and 3 widely used and validated measures of physical functioning—the Short Physical Performance Battery (SPPB), Timed Up and Go (TUG), and Medical Outcomes Study Short Form 36 (SF-36) physical composite scores. We further investigated the additional predictive power of HRV TI on physical health status, as characterized by SF-36 physical composite scores and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scores, using generalized estimating equation regression analyses with backward elimination. Results We observed significant associations of HRV TI with SPPB (n=52; Spearman ρ=0.41; P=.003), TUG (n=51; ρ=−0.40; P=.004), SF-36 physical composite scores (n=49; ρ=0.37; P=.009), and CIRS-G scores (n=52, ρ=−0.43; P=.001). In addition, the HRV TI explained a significant proportion of variance in SF-36 physical composite scores (R2=0.28 vs 0.11 without HRV) and CIRS-G scores (R2=0.33 vs 0.17 without HRV). Conclusions The HRV TI measured with a relatively novel wrist-worn PPG device was related to both objective (SPPB and TUG) and self-reported (SF-36 physical composite) measures of physical function. In addition, the HRV TI explained additional variance in self-reported physical function and cumulative illness severity beyond traditionally measured aspects of physical health. Future steps include longitudinal tracking of changes in both HRV and physical function, which will add important insights regarding the predictive value of HRV as a biomarker of physical health in older adults.

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O16 THE TOR-CONCEPT (TRAINING-OPERATION-REHABILITATION) APPLIED TO A COHORT OF POST-PARTUM WOMEN WITH SYMPTOMATIC DRA (DIASTASIS RECTI ABDOMINIS). EVALUATION OF PHYSICAL FUNCTION AND QUALITY OF LIFE ONE YEAR AFTER SURGERY

British Journal of Surgery ◽

10.1093/bjs/znab396.015 ◽

2021 ◽

Vol 108 (Supplement_8) ◽

Author(s):

Anders Olsson ◽

Katarina Woxnerud ◽

Gabriel Sandblom ◽

Otto Stackelberg

Keyword(s):

Quality Of Life ◽

Physical Function ◽

Surgical Repair ◽

Post Partum ◽

Rehabilitation Program ◽

Diastasis Recti ◽

Sf 36 ◽

One Year ◽

Diastasis Recti Abdominis

Abstract Aim Management of diastasis recti abdominis (DRA) differs regarding core training, surgical repair methods and post-operative rehabilitation. The purpose of this prospective cohort study was to evaluate the effect of a novel concept of treatment for DRA, the TOR-concept (Training, Operation and Rehabilitation). The concept includes preoperative evaluation of symptoms and instructed abdominal core training; tailored surgical repair of the DRA; and an individualized postoperative rehabilitation program. Material and Methods A cohort of seventy-five post-partum women with diagnosed DRA and training resistant core dysfunctions were evaluated and included to the study during 2018-2020. After surgery, all participants underwent an individualized supervised rehabilitation program with progressive increasing load for four months. Physical function was registered preoperatively and one year after surgery with the disability rating index (DRI) questionnaire. Quality of life (QoL) was assessed with the SF-36 questionnaire. The DRA and the surgical result were assessed with ultrasonography before and one year after surgery. Results Sixty-nine participants, 92%, completed the study. There were no DRA-recurrences at the 1-year follow-up. Early results shows that self-reported physical function, (DRI), improved in 88.8 % of patients, with a mean score improvement of 78.5 %. Quality of life, (SF-36), improved significantly compared with the preoperative scores, and reached a level similar to, or higher than, the normative Swedish female population. Conclusions In this cohort of post-partum women with DRA combined with core instability symptoms resistant to training, surgical reconstruction within the TOR-concept resulted in a significant improvement of physical function and QoL.

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