A High-Sensitivity International Knee Documentation Committee Survey Index From the PROMIS System: The Next-Generation Patient-Reported Outcome for a Knee Injury Population

2021 ◽  
pp. 036354652110415
Author(s):  
Matthew S. Tenan ◽  
Richard J. Robins ◽  
Andrew J. Sheean ◽  
Travis J. Dekker ◽  
James R. Bailey ◽  
...  
Keyword(s):  
Physical Function ◽  
Predictive Models ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Prediction Models ◽  
International Knee Documentation Committee ◽  
Index Score ◽  
Pain Interference ◽  
Clinically Important Difference ◽  
Patient Reported

Background: Patient-reported outcomes (PROs) measure progression and quality of care. While legacy PROs such as the International Knee Documentation Committee (IKDC) survey are well-validated, a lengthy PRO creates a time burden on patients, decreasing adherence. In recent years, PROs such as the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference surveys were developed as computer adaptive tests, reducing time to completion. Previous studies have examined correlation between legacy PROs and PROMIS; however, no studies have developed effective prediction models utilizing PROMIS to create an IKDC index. While the IKDC is the standard knee PRO, computer adaptive PROs offer numerous practical advantages. Purpose: To develop a nonlinear predictive model utilizing PROMIS Physical Function and Pain Interference to estimate IKDC survey scores and examine algorithm sensitivity and validity. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: The MOTION (Military Orthopaedics Tracking Injuries and Outcomes Network) database is a prospectively collected repository of PROs and intraoperative variables. Patients undergoing knee surgery completed the IKDC and PROMIS surveys at varying time points. Nonlinear multivariable predictive models using Gaussian and beta distributions were created to establish an IKDC index score, which was then validated using leave-one-out techniques and minimal clinically important difference analysis. Results: A total of 1011 patients completed the IKDC and PROMIS Physical Function and Pain Interference, providing 1618 complete observations. The algorithms for the Gaussian and beta distribution were validated to predict the IKDC (Pearson = 0.84-0.86; R2 = 0.71-0.74; root mean square error = 9.3-10.0). Conclusion: The publicly available predictive models can approximate the IKDC score. The results can be used to compare PROMIS Physical Function and Pain Interference against historical IKDC scores by creating an IKDC index score. Serial use of the IKDC index allows for a lower minimal clinically important difference than the conventional IKDC. PROMIS can be substituted to reduce patient burden, increase completion rates, and produce orthopaedic-specific survey analogs.

scholarly journals Generating the International Knee Documentation Committee Score using PROMIS Computer Adaptive Testing with Multivariable Predictive Models: Reduce Survey Burden with Comparable Data (102)

2021 ◽  
Vol 9 (10_suppl5) ◽  
pp. 2325967121S0025
Author(s):  
Richard Robins ◽  
Mark Slabaugh ◽  
Jonathan Dickens ◽  
Matthew Tenan
Keyword(s):  
Confidence Intervals ◽  
Beta Distribution ◽  
Predictive Models ◽  
Patient Reported Outcomes ◽  
International Knee Documentation Committee ◽  
Adaptive Testing ◽  
Index Score ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Time Burden

Objectives: Patient reported outcomes (PROs) serve as a means of measuring improvement and quality of care. Legacy PROs rely on a list of questions that have had to demonstrate accuracy, responsiveness, and validity in testing for intended measurements. While certain legacy PROs such as the International Knee Documentation Committee (IKDC) survey have demonstrated these properties well, a lengthy PRO creates a time burden on patients, making patient adherence and completion a challenge. In recent years, PROs such as the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) surveys have been developed which leverage computer adaptive testing that produce equivalent accuracy, responsiveness, and validity of legacy PROs, but use only 4-12 questions per survey. This results in significant reduction in time to complete. As these new PROs are now being adopted, the ability to compare outcomes to prior studies that relied on legacy PROs is necessary. While prior studies have examined correlation between legacy PROs and PROMIS computer adaptive tests, no studies to date have developed effective prediction models utilizing PROMIS surveys to create an IKDC index score. The objective of this study was to develop a predictive model utilizing PROMIS PF and PI to effectively recreate IKDC survey scores. Methods: The Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) database is a prospectively collected repository of patient reported outcomes and intraoperative variables. As part of inclusion in MOTION, research patients who underwent knee surgery were asked to complete the IKDC as well as the PROMIS PF and PROMIS PI at varying time points. This cohort of patients that completed both IKDC and PROMIS scores were included in the present analysis. Nonlinear multivariable predictive models using both Gaussian and beta distributions were created to establish an IKDC index score, which was then validated using leave-one-out techniques and minimal clinically important difference (MCID) analysis. Results: A total of 1,011 knee patients (Age: 37.7±14.4 years; 30% Female) completed the IKDC, PROMIS PF, and PROMIS PI providing 1,618 complete observations. The algorithms for both the Gaussian and beta distribution were strongly validated to predict the IKDC (Table 1). The MCID for IKDC was 27.0 (95% confidence intervals: 15.0-39.7) whereas the IKDC-index MCIDs for the Gaussian and beta distribution models were both 13.3 (95% confidence intervals 2.7-27.9), suggesting that the derived IKDC-index is effective and can reliably re-create IKDC scores. The surface plots of this nonlinear multivariable model also confirm the necessity that nonlinear prediction is necessary for effective modeling of legacy PRO scores (Figures 1 & 2). Conclusions: PROMIS PF and PI predictive models are able to approximate the IKDC score within 9.3-10.0 points. Given the 27.0 point minimally clinically important difference for the IKDC survey in this cohort, the results of this study can be used to compare PROMIS PF and PI scores to prior IKDC data by creating an IKDC index score. Moreover, repeated use of the IKDC-index from PROMIS PF and PI allows for a lower MCID than using the conventional IKDC survey. PROMIS PF and PI scores can be substituted in both clinical and research settings to reduce patient time burden, increase completion rates, and still create data that can effectively be compared with studies utilizing legacy IKDC scores.

Generating the American Shoulder and Elbow Surgeons Score Using Multivariable Predictive Models and Computer Adaptive Testing to Reduce Survey Burden

2021 ◽  
Vol 49 (3) ◽  
pp. 764-772
Author(s):  
Matthew S. Tenan ◽  
Joseph W. Galvin ◽  
Timothy C. Mauntel ◽  
John M. Tokish ◽  
James R. Bailey ◽  
...  
Keyword(s):  
Physical Function ◽  
Predictive Model ◽  
Predictive Models ◽  
Patient Reported Outcomes ◽  
Patient Survey ◽  
Patient Reported Outcome ◽  
Pain Interference ◽  
Measurement Information ◽  
Level Of Evidence ◽  
Patient Reported

Background: The preferred patient-reported outcome measure for the assessment of shoulder conditions continues to evolve. Previous studies correlating the Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) to the American Shoulder and Elbow Surgeons (ASES) score have focused on a singular domain (pain or physical function) but have not evaluated the combined domains of pain and physical function that compose the ASES score. Additionally, previous studies have not provided a multivariable prediction tool to convert PROMIS scores to more familiar legacy scores. Purpose: To establish a valid predictive model of ASES scores using a nonlinear combination of PROMIS domains for physical function and pain. Study Design: Cohort study (Diagnosis); Level of evidence, 3. Methods: The Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) database is a prospectively collected repository of patient-reported outcomes and intraoperative variables. Patients in MOTION research who underwent shoulder surgery and completed the ASES, PROMIS Physical Function, and PROMIS Pain Interference at varying time points were included in the present analysis. Nonlinear multivariable predictive models were created to establish an ASES index score and then validated using “leave 1 out” techniques and minimal clinically important difference /substantial clinical benefit (MCID/SCB) analysis. Results: A total of 909 patients completed the ASES, PROMIS Physical Function, and PROMIS Pain Interference at presurgery, 6 weeks, 6 months, and 1 year after surgery, providing 1502 complete observations. The PROMIS CAT predictive model was strongly validated to predict the ASES (Pearson coefficient = 0.76-0.78; R2 = 0.57-0.62; root mean square error = 13.3-14.1). The MCID/SCB for the ASES was 21.7, and the best ASES index MCID/SCB was 19.4, suggesting that the derived ASES index is effective and can reliably re-create ASES scores. Conclusion: The PROMIS CAT predictive models are able to approximate the ASES score within 13 to 14 points, which is 7 points more accurate than the ASES MCID/SCB derived from the sample. Our ASES index algorithm, which is freely available online ( https://osf.io/ctmnd/ ), has a lower MCID/SCB than the ASES itself. This algorithm can be used to decrease patient survey burden by 11 questions and provide a reliable ASES analog to clinicians.

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 Patient-Reported Outcomes after Exosym Bracing (Intrepid Dynamic Exoskeletal Orthosis (IDEO)) in the Civilian Population

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0019
Author(s):  
Ryan Hadden ◽  
James Meeker ◽  
Jason Weiss ◽  
Austin Thompson
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Pain Modulation ◽  
Pain Interference ◽  
Average Score ◽  
Foot And Ankle ◽  
Kinetic Chain ◽  
Civilian Population ◽  
Patients Âgés ◽  
Patient Reported

Category: Ankle Arthritis, Orthosis Introduction/Purpose: When it comes to ambulation, the dynamic interplay of anatomy at the foot and ankle affords weight acceptance, stability and force production. The outcome is gait efficiency. Various musculoskeletal injuries challenge gait biomechanics. While surgical management may address the fault in kinetic chain, it may not fully address the problem of pain, functional outcome and patient satisfaction. Non-surgical interventions such as bracing using ankle foot orthoses (AFO) aim to assist, restore and redirect weightbearing forces with immobility in mind. As an energy-storing AFO, however, the IDEO was created to improve functional performance in veterans after limb salvage procedures. The goal of the study was to evaluate outcomes following use of Exosym (or IDEO) bracing for foot and ankle pathologies in the civilian population. Methods: Through review of one institution’s electronic medical record, 29 patients ages 18 years or older who were prescribed the Exosym brace by a single foot and ankle surgeon over a 5-year period were identified. A composite questionnaire including patient-reported outcomes of PROMIS SF Physical Function, PROMIS SF Pain Interference, Brace Use, and EQ-5D was obtained over the phone or by email. Results: A total of 29 patients were prescribed the brace over a 5-year period with only 18 patients receiving the brace. Insurance denying coverage was the most common reason (n=7) for patients not receiving the brace. Of the 18 patients that received the brace, 17 of them were willing to answer the questionnaire. The average age of patients with the Exosym brace was 42.3 (sd=13.8) years old with 6 (35%) being female. Patients with the Exosym brace reported an average score of 47.2 (sd=6.0) for the PROMIS Physical Function and 53.6 (sd=8.4) for the PROMIS Pain Interference. The average satisfaction with the Exosym brace was 65.5 (sd=17.6) out of a possible 100. Conclusion: Exosym bracing in various foot and ankle pathologies provides functionality and pain modulation in the civilian population that rivals respective subpopulation norms. One of the acknowledged limitations of the study is that not obtaining pre- bracing patient reported outcomes precluded evaluation of a minimum clinically important difference. However, the study was not designed to provide such data. It did, however, provide impetus to pursue a follow-up study evaluating plantar pressure changes with and without brace use, which is currently ongoing. Such knowledge may help identify which injuries would be best suited for Exosym bracing.

Does Obesity Correlate With Worse Patient-Reported Outcomes Following Elective Anterior Cervical Discectomy and Fusion?

Neurosurgery ◽  
2016 ◽  
Vol 79 (1) ◽  
pp. 69-74 ◽  
Author(s):  
John A. Sielatycki ◽  
Chotai Silky ◽  
Kay Harrison ◽  
David Stonko ◽  
Matthew McGirt ◽  
...  
Keyword(s):  
Scale Score ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Japanese Orthopaedic Association Score ◽  
Association Score ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Neck Disability

Abstract BACKGROUND Studies have investigated the impact of obesity in thoracolumbar surgery; however, the effect of obesity on patient-reported outcomes (PROs) following anterior cervical discectomy and fusion (ACDF) is unknown. OBJECTIVE To examine the relationship between obesity and PROs following elective ACDF. METHODS Consecutive patients undergoing ACDF for degenerative conditions were evaluated. Patients were divided into groups with a body mass index ≥35. The EuroQol-5D, Short-Form 12 (SF-12), modified Japanese Orthopaedic Association score, and Neck Disability Index were used. Correlations between PROs and obesity were calculated at baseline and 1 year. RESULTS A total of 299 patients were included, with 80 obese (27%) and 219 nonobese (73%). patients At baseline, obesity was associated with worse myelopathy (modified Japanese Orthopaedic Association score: 10.7 vs 12.2, P = .01), general physical health (SF-12 physical component scale score: 28.7 vs 31.8, P = .02), and general mental health (SF-12 mental component scale score: 38.9 vs 42.3, P = .04). All PROs improved significantly following surgery in both groups. There was no difference in absolute scores and change scores for any PRO at 12 months following surgery. Furthermore, there was no difference in the percentage of patients achieving a minimal clinically important difference for the Neck Disability Index (52% vs 56%, P = .51) and no difference in patient satisfaction (85% vs 85%, P = .85) between groups. CONCLUSION Obesity was not associated with less improvement in PROs following ACDF. There was no difference in the proportion of patients satisfied with surgery and those achieving a minimal clinically important difference across all PROs. Obese patients may therefore achieve meaningful improvement following elective ACDF.

scholarly journals GC-PROM: Validation of a patient-reported outcomes measure for patients with gastric cancer

2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Test Theory ◽  
Shanxi Province ◽  
Draft Guidance ◽  
Evaluation Instrument ◽  
Clinically Important Difference ◽  
Filling Time ◽  
Patient Reported

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for patients with gastric cancer. Method: Following the FDA's draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for patients with gastric cancer.

scholarly journals Assessing Elite Athletes Using PROMIS Tools: The STEALTH Project (Student Athlete Health Assessment)

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0039
Author(s):  
Shanthan Challa ◽  
Marissa Holliday ◽  
Kenneth Bartolomei ◽  
Jonathan Bartolomei
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Computerized Adaptive Testing ◽  
Elite Athletes ◽  
Assessment Tools ◽  
Pain Interference ◽  
Significant Difference ◽  
Patient Reported ◽  
Division 1 ◽  
The Impact

Objectives: Injuries are a major part of elite sports, and patient-reported outcomes tools (PROs) are becoming commonplace for the assessment of injury and treatment outcomes. The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated set of assessment tools with increasing popularity. The PROMIS metrics utilize computerized adaptive testing (CAT) to capture health status measurements through individualized assessments, with minimal user burden, and without the loss of precision or content validity. The purpose of this study was to evaluate elite athletes using PROMIS scores and assess the impact of injury on those scores to gain insight into how participation and injury can impact the health of NCAA Division 1 athletes participating in a variety of sports. Methods: Over six months, athletes from 11 sports at a single Division 1 Athletics program were recruited to participate in longitudinal prospective data collection using four PROMIS CAT scales/domains: Pain Interference (PI), Physical Function (PF), Depression, and Ability to Participate in Social Roles and Activities (PSRA). Using REDCap (Research Electronic Data Capture), athletes completed an assessment that included the PROMIS tools before participation in their respective sport’s season for the 2018-2019 academic year and following the completion of their season. Athletes suffering a season-ending injury were asked to complete the PROMIS survey within a week following the injury. De-identified data was analyzed using Student’s T-test. PROMIS outcome measures were analyzed using linear mixed model regression. A p-value of < 0.05 was considered statistically significant. Results: A total of 592 surveys were collected, composed of 320 pre-season surveys, 241 post-season surveys, and 31 season altering injury surveys. PF, Depression, and PSRA scores were significantly different in athletes than in the general age-matched population (Fig 1). PI scores were similar to the normal population. The distribution of PI and PF scores were significantly different pre and post-season with a difference in means of 1.499 (p=0.030) and -2.019 (p=0.005), respectively. No significant difference was observed in the Depression and PSRA scores at the end of the season (Fig 1). A total of 31 significant injuries were reported. Injuries resulted in a significant change from pre-season to post-season scores amongst all participants (Fig 1). Conclusion: There were significantly worse pain interference and physical function scores post-season compared to preseason, suggesting that athletic participation alone may impact the athlete’s overall function and condition. Season-altering injuries resulted in clinically significant differences in all four domains, PI, PF, Depression, and PSRA, suggesting that injuries greatly affect athletes not only physically, but mentally and socially as well. Statistically significant changes were seen in depression and social metrics after injury compared to the athlete’s pre-season scores. Consideration should be given to index pre-season PROMIS scores for individual athletes to make follow-up scores athlete-specific, meaningful, and actionable. There is a clear need for additional investigation into the impact of specific sports and specific injuries, which would be valuable to trainers, coaches, and clinicians to inform treatment and return to sport protocols.

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