PROMIS Patient Reported Pain Outcomes Compared With Numerical Pain Score Before and After Ankle Surgery

Category: Patient Reported Outcomes Introduction/Purpose: Patient reported outcomes (PRO) are important for measuring clinical changes after surgical intervention. This study compares PROMIS pain intensity, PROMIS pain interference, and a zero-to-ten numerical pain score (NPS) before and after three common ankle surgeries to test the hypothesis that pain improvement is measurable by each scale. In addition, the effects size (ES) of each scale is compared to help determine which scale may provide the most power to detect an improvement in pain. Methods: PRO scores were routinely collected during clinic visits between 2015 and 2018. Over 175 patients who had undergone total ankle replacement, subtalar fusion, or lateral ankle ligament stabilization were identified in the electronic health record using the surgical billing codes for these procedures. The most recent preoperative and postoperative PROs for these patients were compared by Mann-Whitney U, and effect size was calculated using Cohen’s d. Results: For total ankle replacement, NPS, pain intensity, and pain interference all improved (p<0.05) with ES 1.29, 0.95, and 0.63 respectively. For subtalar fusion, NPS, and pain interference improved (p<0.05) with ES 0.86 and 0.54; pain intensity (p=0.21) was unchanged with ES 0.30. For lateral ankle ligament stabilization, NPS, and pain interference improved (p<0.05) with ES 0.49 and 0.59; pain intensity (p=0.49) was unchanged with ES 0.19. Conclusion: While both NPS and PROMIS pain interference consistently demonstrated improvements after common ankle surgeries, NPS is preferable given its single question format and greater effect size in two of the three procedures studies. PROMIS pain intensity did not routinely measure changes in our surgical population questioning its utility.

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Patient-Reported Outcomes Demonstrate The Value Of Non-Operative And Operative Orthopedic Treatments And Predict The Odds Of Improvement With Surgery

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000047 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0000

Author(s):

Andrew Haskell ◽

Todd S. Kim

Keyword(s):

Pain Intensity ◽

Patient Reported Outcomes ◽

Pain Interference ◽

Surgical Patients ◽

Final Visit ◽

Adaptive Tests ◽

Item Banks ◽

Patient Reported ◽

Computer Adaptive Tests ◽

Better Than

Category: Outcomes Measurement Introduction/Purpose: The importance of patient reported outcomes (PROs) has become increasingly recognized as an important tool to measure our clinical value. The National Institute of Health (NIH) created the Patient-Reported Outcomes Measurement Information System (PROMIS), a series of validated item banks, to help clinicians and researches measure key clinical domains. The PROMIS computer adaptive tests (CAT) may be administered with minimal resources or administrative burden. This study describes the results of administering computer adaptive tests (CAT) to every patient in a high volume Orthopedic Surgery practice. We test the hypotheses that both non-operative treatment and operative treatments improve PRO scores. Furthermore, we test the hypothesis that preoperative scores in these domains may be used to predict chances of improvement after surgery. Methods: The PROMIS CAT was administered prospectively for all patients as part of standard clinic intake and recorded in the patient’s electronic medical record (EMR) at each clinic visit. The PROMIS item banks are normalized to mean 50±10 for the US population. De-identified data was retrospectively extracted from the EMR including PROMIS scores, demographic information, as well as surgery specific information. As of this submission, 1688 PROMIS CATs from March 2015 to September 2016 have been analyzed. Data for initial and final clinic visits, as well as for the final preoperative visit for patients who had surgery, are compared using Wilcoxon Matched Pairs Test for paired samples and Mann-Whitney U Test for unpaired samples. Linear regression is used to assess the association of initial values to change in value after treatment. The effect of stratified initial clinic domain value on odds of improving with surgery is assessed using Analysis of Variance. Results: Non-surgical and surgical patients present with similar pain intensity (49.6±7.9 vs. 49.4±7.8). Surgical patients do not improve prior to surgery, but both improve by their final visit (45.7±7.5, 43.7±8.8, p<0.05). Non-surgical and surgical patients present with similar pain interference (60.0±8.4 vs. 60.3±8.9). Surgical patients do not improve prior to surgery, but both improve by their final visit (56.9±8.8, 54.3±9.4, p<0.05). For surgical patients, change in pain intensity and pain interference correlate with initial values (R2 0.32 and 0.27, p<0.05). The percentage whose pain intensity improves after surgery when initial value is over one SD worse than mean is 96%, within one SD worse than mean is 81%, within one SD better than mean is 56%, and over one SD better than mean is 40% (p<0.05). Conclusion: Both non-operative and operative orthopedic treatments improve patient reported pain intensity and pain interference. For patients that have surgery, patients that present with more severe symptoms tend to improve more with surgery. Furthermore, the odds of improving after surgery can be calculated based on preoperative PRO scores. This may allow surgeons to counsel patients about the potential benefits of surgery with personalized precision that is currently unavailable. Measuring PROs using PROMIS CATs demonstrates the value of both non-operative and operative Orthopedic Surgery care for our patients. Preoperative PRO scores may predict the odds of successful surgical intervention.

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The Influence of Preoperative Deformity Severity in Postoperative Patient Reported Outcomes in Adult Acquired Flatfoot

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00028 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0002

Author(s):

Bopha Chrea ◽

Cesar de Cesar Netto ◽

Jonathan H. Garfinkel ◽

Jonathan Day ◽

Guilherme H. Saito ◽

...

Keyword(s):

Mental Health ◽

Pain Intensity ◽

Subtalar Joint ◽

Patient Reported Outcomes ◽

Global Mental Health ◽

Multivariate Regression Analysis ◽

Pain Interference ◽

T Score ◽

Metatarsal Angle ◽

Patient Reported

Category: Ankle; Hindfoot; Other Introduction/Purpose: Adult acquired flatfoot deformity (AAFD) is a complex deformity. Previous work has demonstrated correlation between postoperative foot alignment and patient-reported outcomes. While this work has provided essential targets for surgeons performing flatfoot reconstruction, there is an absence of data that would enable surgeons to predict which patients are likely to have greater or less improvement after surgery based on their preoperative deformity. Conventional radiographs alone may not provide enough detail to isolate individual elements of the deformity. Weightbearing CT (WBCT) allows for far more precise analysis in this regard. We hypothesized that there would be a set of parameters defining preoperative alignment on WBCT that would predict which patients are at risk for a lower magnitude of postoperative improvement in patient-reported outcomes (PROs). Methods: In this retrospective IRB-approved study, patients that underwent surgical flatfoot reconstruction after having a preoperative standing WBCT were identified. Preoperative WBCT images were evaluated by two independent/blinded observers. Multiple parameters related to preoperative alignment and AAFD severity were measured in the sagittal, coronal and transverse planes. Parameters measured included talus-first metatarsal angle; distances between the floor and the navicular, medial cuneiform and cuboid; subtalar joint horizontal angle; superior talar - inferior talar angle; subtalar joint subluxation; talonavicular uncoverage angle; hindfoot moment arm (HMA); and foot and ankle offset (FAO). Prospectively collected data regarding preoperative and postoperative PROs was evaluated. Six PROs components were assessed: physical function; pain interference, pain intensity, global mental health, global physical health and depression. Multivariate regression analysis and a partition prediction model were used to assess the correlation between preoperative alignment and improvement in PROs. P-values of less than 0.05 were considered significant. Results: A total of 51 patients with a preoperative WBCT and postoperative PROs scores were identified and included. Demographic data is shown in Table 1. Multivariate regression analysis demonstrated that preoperative alignment significantly correlated with improvement in three out six components of PROs: pain interference, pain intensity and global mental health. The strongest predictor of improvement in PROMIS physical function t-score was medial cuneiform to floor distance, for pain interference t-score: cuboid to floor distance, for pain intensity: subtalar joint subluxation, for depression t-score: superior talar - inferior talar angle, and for global physical and mental health t-scores: sagittal talus-first metatarsal angle. Conclusion: Our analysis yielded readily identifiable cutoffs for WBCT measurements, where values above or below were correlated with significant differences in the magnitude of PRO score change. Interestingly, measures of sagittal plane collapse and hindfoot valgus were the most predictive of score changes. This data provides useful information for surgeons counseling patients prior to flatfoot reconstruction. Future work using this data to develop prediction models for postoperative outcomes would be valuable, as would studies using WBCT to evaluate the relationship between postoperative corrected alignment and PROs. Complete results are shown in the attached Table.

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Trends in PROMIS Scores in the Early Post-operative Period following Various Lateral Ankle Ligament Reconstructive Techniques

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000276 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0002

Author(s):

Ashlee MacDonald ◽

Jeff Houck ◽

John Ketz ◽

Judith Baumhauer ◽

Irvin Oh ◽

...

Keyword(s):

Ligament Reconstruction ◽

Scoring Systems ◽

Measurement Information ◽

Chronic Instability ◽

Lateral Ankle ◽

Ankle Ligament ◽

Patient Reported ◽

Lateral Ankle Ligament ◽

Lateral Ankle Ligament Reconstruction

Category: Sports Introduction/Purpose: Lateral ankle ligament injuries are common conditions accounting for 25% of musculoskeletal injuries. When conservative management fails and chronic instability ensues, operative treatment is often sought. Though surgical outcomes are generally good following lateral ankle ligament reconstruction, literature suggests current scoring systems for evaluating outcomes and monitoring progression have deficiencies. Patient Reported Outcomes Measurement Information (PROMIS) scores have recently been established as a method of monitoring patient outcomes. The purpose of this study was to evaluate the trends in post-operative PROMIS physical function (PF), pain interference (PI), and depression scores in patients undergoing lateral ankle ligament reconstruction. Methods: PROMIS scores were prospectively obtained from all patients evaluated in our foot and ankle clinic between February 2015 and October 2016. Using ICD-9/10 and CPT codes, a total of 111 patients who underwent lateral ankle ligament reconstruction were identified. After meeting exclusion criteria (less than three-month follow-up, incomplete PROMIS scores or multiple surgeries), 55 patients were included. PROMIS PF, PI, and depression were evaluated at each post-operative visit. Changes in scores were calculated as compared to baseline pre-operative scores and compared at each follow-up time point using two-way ANOVA. Differences in reconstruction type in patients undergoing allograft (A), modified Broström-Gould (BG), or modified Broström-Gould augmented with fibertape (BG+FT) were also evaluated. Results: The average follow-up was 27.05 weeks (range 12-60.1 weeks). 11 patients had > 9 months follow-up. Changes in PF were significantly different from baseline at all time-points except for 8-12 week follow-up. PF was significantly worse at 2 and 4-6 week follow-up, and significantly better at >12 weeks follow-up (p<0.01). PI significantly improved from baseline beginning at 8-12 week follow-up (p=0.02). Depression was unchanged from baseline at 2 weeks and 4-6 week follow-up, then significantly improved thereafter (p<0.01). Though not significant, when comparing reconstruction types, there was a trend towards slower improvement in PF in those with BG+FT (n=15), compared to A (n=17, p=0.07) and BG (n=21, p=0.051) at 8-12 weeks. Two patients had other types of reconstruction and were not included in this analysis. Conclusion: Patients undergoing lateral ankle ligament reconstruction demonstrate significant improvements in PF, PI, and depression PROMIS scores compared to baseline. Patients reached baseline PF at 8-12 weeks follow-up, and significantly improved beyond >12 weeks. PI scores were significantly improved from baseline beginning at 4 weeks follow-up. Depression scores also significantly improved at 8-12 weeks follow-up. BG+FT showed a trend of slower improvement in PF, though not significant. Though longer follow-up is needed, the significant improvements in PF, PI, and depression following lateral ankle ligament reconstruction in our study provides data that can be used for pre-operative counseling and monitoring progression post-operatively.

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Implementation of Patient-Reported Outcomes Measurement Information System (PROMIS) Data Collection in a Private Orthopedic Surgery Practice

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000013 ◽

2017 ◽

Vol 2 (2) ◽

pp. 2473011416S0001

Author(s):

Andrew Haskell ◽

Todd Kim

Keyword(s):

Pain Intensity ◽

Orthopedic Surgery ◽

Patient Reported Outcomes ◽

Global Mental Health ◽

Pain Interference ◽

Measurement Information ◽

Outcomes Measurement ◽

Item Banks ◽

Patient Reported ◽

Measurement Information System

Category: Other Introduction/Purpose: The use of computerized adaptive testing (CAT) allows measurement of patient reported outcomes (PROs) through the fewest number of questions while achieving a higher precision, diminished floor and ceiling effects, and minimal administration burden compared with traditional methods. The National Institute of Health (NIH) created the Patient-Reported Outcomes Measurement Information System (PROMIS), a series of validated item banks that measure key clinical domains. Each item bank has as few as 4 questions or up to 12 questions depending on the subject’s answers. This study describes a method of administering the PROMIS CAT in a high volume Orthopedic Surgery practice, reports the administration burden and rate of patient capture, compares this population to previously reported national standards, and compares preoperative to postoperative pain item banks. Methods: The PROMIS CAT was intended to be collected prospectively for all patients as part of a standard intake. Patients used a tablet-based program that accesses the NIH PROMIS server generating a CAT in English or Spanish. Clinical domains include physical function, pain intensity, pain interference, global physical health, and global mental health. Scores for each domain and the time required were recorded in the patient’s electronic medical record (EMR) as part of their clinic visit, preserving confidentiality of the data and preventing the need for a separate database. De-identified data was retrospectively extracted from the EMR of every patient from March to December 2015. Results for each domain were compared to validated national norms using single variable t-test. Linear regression was used to assess the effect of age on outcome variables. Paired t-test was used to compare preoperative and postoperative pain intensity and pain interference when these scores were available. Results: 1688 PROMIS CATs were administered during 5345 visits (32%), reaching 70% as logistical issues were resolved. Patient age was 53±16. Completing the CAT required 157±164 seconds, with older patients taking 10.5 more seconds per decade (p < 0.05). The PROMIS item banks are normalized to mean 50±10 for the US population. Our results were: pain intensity 47.8±8.6*, pain interference 57.9±8.8*, physical function 40.1±9.0*, global physical health 43.3±9.6*, and global mental health 48.4±8.9 (*p < 0.05). Age has a small effect on all domains (p < 0.05). Approximately 20 patients are required to demonstrate a 15% change for a two-tailed, paired study with α=0.05 and 80% power. 109 patients had pre and postoperative PROMIS data. Pain intensity improved from 51.8±7.8 to 44.6±8.6 (p < 0.001) and pain interference improved from 60.1±8.8 to 55.5±9.0 (p < 0.001). Conclusion: Using tablets to access PROMIS CATs and entering the data in the patient’s chart for later retrieval is an effective technique to collect PROs in a busy Orthopedic Surgery practice with limited resources and no research coordinator. The process adds 2.5 minutes to a patient’s intake and does not require a complicated database or expensive equipment or licensing. Adequate number of tablets and “buy in” from staff are needed for acceptable completion rates. Demonstrating improvement in PROs after surgery holds promise for comparative studies of surgical indications and techniques and highlights the value these interventions add to patient care.

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Preoperative PROMIS Physical Function Scores Predict Postoperative Outcomes Following Total Ankle Replacement

Foot & Ankle Orthopaedics ◽

10.1177/24730114211020335 ◽

2021 ◽

Vol 6 (3) ◽

pp. 247301142110203

Author(s):

Matthew S. Conti ◽

Kristin C. Caolo ◽

Agnes D. Cororaton ◽

Jonathan T. Deland ◽

Constantine A. Demetracopoulos ◽

...

Keyword(s):

Pain Intensity ◽

Physical Function ◽

Outcome Measurement ◽

Total Ankle Replacement ◽

Postoperative Outcomes ◽

Pain Interference ◽

Measurement Information ◽

Ankle Replacement ◽

Patient Reported ◽

Postoperative Improvement

Background: Despite good evidence that supports significant improvements in pain and physical function following a total ankle replacement (TAR) for end-stage ankle arthritis, there is a subset of patients who do not significantly benefit from surgery. The purpose of this study was to perform a preliminary analysis to determine if preoperative Patient-Reported Outcome Measurement Information System (PROMIS) scores could be used to predict which patients were at risk of not meaningfully improving following a TAR. Methods: Prospectively collected preoperative and ≥2-year postoperative PROMIS physical function, pain interference, pain intensity, and depression scores for 111 feet in 105 patients were included in the study. Significant postoperative improvement was defined using minimal clinically important differences (MCIDs). Logistic regression models and area under the curve (AUC) analyses were used to determine whether preoperative PROMIS scores were predictive of postoperative outcomes. Results: Receiver operating characteristic curves found statistically significant AUCs for the PROMIS physical function (AUC = 0.728, P = .004), pain intensity (AUC = 0.720, P = .018), and depression (AUC = 0.761, P < .001) domains. The preoperative PROMIS pain interference domain did not achieve a statistically significant AUC. Conclusion: Preoperative PROMIS physical function and pain intensity t scores may be used to predict postoperative improvement in patients following a fixed-bearing TAR; however, preoperative PROMIS pain interference scores were not good predictors. The results of this study may be used to guide research regarding patient-reported outcomes following TAR. Level of Evidence: Level III, retrospective comparative series.

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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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Identifying Foot and Ankle Patients at Risk to Fall Based on Patient Reported Outcomes Assessments

Foot & Ankle Orthopaedics ◽

10.1177/2473011418s00026 ◽

2018 ◽

Vol 3 (3) ◽

pp. 2473011418S0002

Author(s):

Judith Baumhauer ◽

Jack Teitel ◽

Allison McIntyre ◽

David Mitten ◽

Jeff Houck

Keyword(s):

At Risk ◽

Effect Size ◽

Fall Risk ◽

Patient Reported Outcomes ◽

The United States ◽

Foot And Ankle ◽

Falls Risk ◽

Orthopaedic Patients ◽

Patient Reported ◽

Patients At Risk

Category: Other Introduction/Purpose: Each year approximately 30-40% of people over the age of 65 fall. Approximately one half of these falls result in an injury with the estimated annual direct medical costs of $30 billion. Pain, mobility issues, neuropathy and post-operative weight bearing limitations make foot and ankle patients particularly vulnerable to falls. Current approaches to determine at risk patients are cumbersome and time consuming requiring performance testing and “hands on” clinical assessment. The efficiency of obtaining PRO, such as PROMIS, in the clinical arena has been well documented. The purpose of this study is determine if patient reported outcomes (PROMIS) can identify orthopaedic and specifically foot and ankle patients at risk to fall. Methods: Prospective patient reported outcomes (PROMIS CAT physical function, pain interference and depression and CMS fall risk assessment questions) and patient demographics were collected for all patients at each clinic visit from an academic orthopaedic multi-specialty practice between January 2015 and November 2017. Standardized yes/no validated self-reported fall risk questions include: “Have you fallen in the last year?” and “Do you feel you are at risk of falling?” Histograms, t-tests, confidence intervals and effect size were used to determine the fall risk “YES” patients were different than the “NO” for ALL orthopaedic patients and specifically foot and ankle patients. Logistic Regression was used to determine if age, gender, height, weight, and PROMIS scales predicted self-reported falls risk. Results: 94,761 orthopaedic patients comprising 315,273 visits (44% male, mean age 53.7+/-17 years) and 13,720 foot/ankle patients comprising 33,480 visits (37% male, mean age 52.7+/-16.1 years) had complete data for analysis. Table 1 provides the means/SD/p-values/effect sizes for patient self-identifying at risk to fall stratified by PROMIS PF/ PI/Dep t-scores. Although all PROMIS scores demonstrated significant impairment between patients at risk designation (yes/no), PROMIS PF had the largest effect size for ALL Ortho and FOOT AND ANKLE patients (0.8 and 0.7 respectively). Patients who are at risk to fall have PROMIS PF t-scores >1.5 lower than the United States normative population while the patients not at risk are less <1 SD. In the adjusted regression models gender and PROMIS PF had the largest coefficients. Conclusion: Falls are a major threat to quality of life and independence yet prevention/treatment strategies are difficult to implement across a health system. There is also a tremendous societal cost with orthopaedic surgeons often the recipient of these debilitated patients. PROMIS assessments are part of the AOFAS OFAR initiative to track patient recovery with treatment and can additional be used to fulfill a quality indicator requirement by CMS. This study demonstrates these assessments (PROMIS threshold values) can also be linked to self-report falls risk (yes/no) and may identify patients at risk with no face to face time required from the provider.

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