Improved Physical Function and Pain Scores after Lower Extremity Osseointegrated Implant Placement: a Closer Look at Complications and Patient-reported Outcomes

Category: Ankle Introduction/Purpose: Peroneal tendon tears are a common cause of lateral ankle pain. When the tear involves more than 50% of the tendon’s cross-sectional area, the treatment algorithm recommends tenodesis of the torn peroneal tendon to the intact peroneal tendon. Previous assessments in the literature of functional outcomes after peroneal tenodesis have widely used the American Orthopedic Foot and Ankle Score (AOFAS) survey as a measurement tool. However, this score was not designed for patient-reported outcomes and its validity and reliability have been questioned. The Medical Outcomes Shortform-36 (SF-36) and PROMIS are tools that have been extensively studied and validated. We sought to assess patient outcomes after peroneal tenodesis using validated tools: SF-36, PROMIS and AOS Disability scores. Methods: Prospective data was collected on patients undergoing peroneal tenodesis for peroneal tendon tears, and who follow up of at least one year. Patients who underwent concomitant procedures (hindfoot fusion, total ankle arthroplasty) were excluded from the study. Baseline patient-reported outcomes (PRO) scores were obtained preoperatively and compared to scores obtained at one year postoperatively. Results: We identified seventeen patients who underwent peroneal tenodesis for peroneal tendon tears. Average age was 62.1 years. SF-36 Physical Function scores increased from an average of 42.0 preop to 60.0 postop (p = 0.0095). PROMIS scores increased from 40.3 to 42.7 (p = 0.3049). There was no statistically significant improvement in postoperative SF-36 Pain scores (p = 0.3216). AOS Disability Scores dropped from 49.6 preop to 38.2 postop (p = 0.3178). AOS Pain scores decreased from 40.7 to 27.0 (p = 0.1779). Total AOS score decreased from 45.1 to 32.6 (p = 0.2204). Conclusion: The SF-36 Physical Function score, which is a validated outcome measure, showed statistically significant improvement postoperatively. Some of the other PROs for peroneal tenodesis failed to show statistically significant improvements, and this is most likely due to low numbers, rendering the cohort somewhat under-powered. Though the data is preliminary, the non-significant scores trended toward improvement. Despite the preliminary nature of this study, satisfactory outcomes of peroneal tenodesis using validated patient-reported outcome scores are demonstrated for the first time. Further study is underway to enlarge the scope of this investigation.

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Percutaneous Treatment of Achilles Tendon Rupture: A Patient Report Outcome Study

Foot & Ankle Orthopaedics ◽

10.1177/2473011419s00277 ◽

2019 ◽

Vol 4 (4) ◽

pp. 2473011419S0027

Author(s):

Mateus C. Lima ◽

Milap S. Patel ◽

Anish R. Kadakia

Keyword(s):

Achilles Tendon ◽

Physical Function ◽

Patient Reported Outcomes ◽

Achilles Tendon Rupture ◽

Mean Difference ◽

Rank Test ◽

Pain Scores ◽

Signed Rank ◽

Patient Reported ◽

Signed Rank Test

Category: Sports, Achilles Tendon Introduction/Purpose: Achilles tendon rupture is a common injury with increasing incidence in adults. While multiple studies have been conducted to determine the optimal surgery for an Achilles rupture, there is a lack of consensus around which surgical method serves as the best treatment. The predominant surgical options that are currently performed include open repair and minimally invasive or percutaneous Achilles rupture surgery (PARS), with comparative studies between open and PARS showing similar functional results. However, there is a lack of objective patient reported outcomes (PRO) for these procedures in the literature. To our knowledge, our study is the first prospective study to use validated patient reported outcomes (PROMIS®) to compare pre-operative and post- operative outcomes for the PARS surgery. Methods: Pre- and post-operative data for the PROMIS Physical Function and Pain Interference Computer Adaptive Tests (CATs) was collected for over 100 Achilles rupture patients at a major tertiary care facility and level I trauma center starting in 2014. Each of these patients were contacted at regular intervals for repeat survey evaluation at multiple post-operative time points via email or phone. Patients treated for chronic Achilles rupture as well as patients without adequate post- operative follow up of a minimum of 2 years were excluded. We conducted a preliminary analysis on a total of 21 patients with acute Achilles rupture Injury treated with PARS and 2 years post- operative PROMIS follow up. For each outcome, a Wilcoxon signed-rank test was used to assess the mean difference between pre-operative and post-operative scores. The statistical analysis was conducted by statisticians who were blinded and worked independently of the orthopedics department. Results: Based on the Wilcoxon signed-rank test, there was significant mean difference between pre-op and post-op physical function scores (p=0.0009 < 0.05) and no significant mean difference between pre-op and post-op pain scores (p=0.1743 > 0.05). Mean post-operative scores were at the 54th percentile for function and 44th percentile for pain. Conclusion: While our study is a preliminary investigation into the use patient-reported outcomes in determining the outcomes of PARS, we aim to expand on our findings as more patients reach 2-year post- operative status. Our preliminary findings are however consistent with the literature regarding the viability of PARS in treating acute Achilles ruptures with positive results similar to other techniques. While patients’ experience a minor loss in post-operative physical function as compared to their pre- injury status, PARS restores physical function scores to that of the mean population while restoring pain scores to baseline levels.

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

The Journal of Knee Surgery ◽

10.1055/s-0040-1716358 ◽

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.

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

Arthritis Research & Therapy ◽

10.1186/s13075-021-02430-0 ◽

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.

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Patient Reported Outcomes (PROs) – a Tool for Strengthening Patient Involvement and Measuring Outcome in Orthopaedic Outpatient Rehabilitation

Zeitschrift für Orthopädie und Unfallchirurgie ◽

10.1055/a-1241-4897 ◽

2020 ◽

Author(s):

Marcus Müller ◽

Joscha Brunssen ◽

Martin Messingschlager

Keyword(s):

Lower Extremity ◽

Patient Reported Outcomes ◽

Patient Involvement ◽

Pain Treatment ◽

Cervical Disc ◽

Outpatient Rehabilitation ◽

Positive Effects ◽

Disc Surgery ◽

Patient Reported ◽

Quick Dash

AbstractThe present study serves to establish Patient Reported Outcomes (PROs) as a tool for strengthening patient involvement and measuring outcomes in orthopaedic outpatient rehabilitation. Assessments by FFbH-R (Hannover Back Function Questionnaire for patients with back problems), Quick-DASH (Disabilities of Arm, Shoulder, and Hand Score for patients with upper extremity lesions), and LEFS (Lower Extremity Function Scale for patients with lower extremity lesions) were employed in 20 outpatient rehabilitation centres over a period of 12 months to evaluate changes in performance and participation from the subjective patient perspective. The following questionnaires were used: FFbH-R status post: lumbar disc surgery; cervical disc surgery; spinal canal decompression; conservative back pain treatment; other; Quick-DASH status post: rotator cuff reconstruction; shoulder arthroplasty; fracture (conservative or osteosynthesis); other; LEFS status post: hip arthroplasty; knee arthroplasty; anterior cruciate ligament repair; osteotomy; fracture (conservative treatment or osteosynthesis); other. Analysis of the 6,751 usable data sets demonstrated significant positive changes in all scores and diagnostic subgroups. The mean difference in score was 14.2 points in the FFbH-R, − 22 points in the Quick-DASH and 18 points in the LEFS. Thus, this study proves the positive effects of orthopaedic rehabilitation in an outpatient setting. PROs were instituted on a permanent basis in seven of the participating institutions.

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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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SAT0121 PAIN AND OTHER PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DID OR DID NOT ACHIEVE TREATMENT RESPONSE BASED ON IMPROVEMENT IN SWOLLEN JOINTS IN TOCILIZUMAB CLINICAL TRIALS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.967 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 994.2-995

Author(s):

A. Sebba ◽

J. Han ◽

S. Mohan

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trials ◽

Pain Score ◽

Patient Reported Outcomes ◽

Component Score ◽

Link Type ◽

Pain Scores ◽

Sf 36 ◽

Patient Reported ◽

Nonresponder Group

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

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