Role of Patient-Reported Outcome Measures on Predicting Outcome of Bunion Surgery

Background: Prior studies have suggested preoperative patient-reported outcome scores could predict patients who would achieve a clinically meaningful improvement with hallux valgus surgery. Our goal was to determine bunionectomyspecific thresholds using Patient-Reported Outcomes Measurement Information System (PROMIS) values to predict patients who would or would not benefit from bunion surgery. Methods: PROMIS physical function (PF), pain interference (PI), and depression assessments were prospectively collected. Forty-two patients were included in the study. Using preoperative and final follow-up visit scores, minimally clinically important differences (MCID), receiver operating characteristic (ROC) curves, and area under the curve (AUC) analyses were performed to determine if preoperative PROMIS scores predicted achieving MCID with 95% specificity or failing to achieve an MCID with 95% sensitivity. Results: PROMIS PF demonstrated a significant AUC and likelihood ratio. The preoperative threshold score for failing to achieve MCID for PF was 49.6 with 95% sensitivity. The likelihood ratio was 0.14 (confidence interval, 0.02-0.94). The posttest probability of failure to achieve an MCID for PF was 94.1%. PI and depression AUCs were not significant, and thus thresholds were not determined. Conclusion: We identified a PF threshold of 49.6, which was nearly 1 standard deviation higher than previously published. If a patient is hoping to improve PF, a patient with a preoperative t score \u3e49.6 may not benefit from surgery. This study also suggests the need for additional research to delineate procedure-specific thresholds. Level of Evidence: Level III, retrospective comparative series

What is the Responsiveness and Quality of Life “Utility” for PROMIS Outcomes in Foot and Ankle Patients Following Physical Therapy?

Introduction/Purpose: Patients with foot and ankle conditions have been shown to demonstrate improvement in their generic outcomes using the Patient Reported Outcome Measurement Information System (PROMIS). However, the responsiveness to change and the impact change may have on quality of life has not been explored following non-operative care with physical therapy. The effect size (ES) is an assessment of the magnitude of change while the impact of change in physical function can be assed with quality of life utility scores. Therefore, the purpose of this analysis was to investigate the responsiveness of the PROMIS physical function (PF) scale on changes in quality of life

Improving Interpretation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Scale for Specific Tasks in Community-Dwelling Older Adults

Background and purpose: New generic patient-reported outcomes like the Patient-Reported Outcomes Measurement Information System (PROMIS) are available to physical therapists to assess physical function. However, the interpretation of the PROMIS Physical Function (PF) T-score is abstract because it references the United States average and not specific tasks. The purposes of this study were to (1) determine convergent validity of the PROMIS PF scale with physical performance tests; (2) compare predicted performance test values to normative data; and (3) identify sets of PROMIS PF items similar to performance tests that also scale in increasing difficulty and align with normative data. Methods: Community-dwelling older adults (n = 45; age = 77.1 ± 4.6 years) were recruited for this cross-sectional analysis of PROMIS PF and physical performance tests. The modified Physical Performance Test (mPPT), a multicomponent test of mostly timed items, was completed during the same session as the PROMIS PF scale. Regression analysis examined the relationship of mPPT total and component scores (walking velocity, stair ascent, and 5 times sit to stand) with the PROMIS PF scale T-scores. Normative data were compared with regression-predicted mPPT timed performance across PROMIS PF T-scores. The PROMIS PF items most similar to walking, stair ascent, or sit to stand were identified and then PROMIS PF model parameter-calibrated T-scores for these items were compared alongside normative data. Results and discussion: There were statistically significant correlations (r = 0.32-0.64) between PROMIS PF T-score and mPPT total and component scores. Regression-predicted times for walking, stair ascent, and sit-to-stand tasks (based on T-scores) aligned with published normative values for older adults. Selected PF items for stair ascent and walking scaled well to discriminate increasing difficulty; however, sit-to-stand items discriminated only lower levels of functioning. Conclusions: The PROMIS PF T-scores showed convergent validity with physical performance and aligned with published normative data. While the findings are not predictive of individual performance, they improve clinical interpretation by estimating a range of expected performance for walking, stair ascent, and sit to stand. These findings support application of T-scores in physical therapy testing, goal setting, and wellness plans of care for community-dwelling older adults

What Are Typical Outcomes Associated with Physical Therapy for Foot & Ankle Patients?

Introduction/Purpose: It is unclear whether patients attending physical therapy, post-op or for conservative care, achieve clinically important differences (CID) on the patient reported outcome information system (PROMIS) scales. Key PROMIS outcomes physical function (PF) and pain interference (PI) match well with treatments provided in physical therapy. Physical therapy may also influence depression (Dep). Documentation of PROMIS outcomes associated with physical therapy are useful to help set patient expectations. The purpose of this analysis was to document expected PROMIS PF, PI, and Dep outcomes after physical therapy for foot and ankle diagnoses by 1) reporting average improvement and 2) examining whether severity of symptoms (PROMIS Scales) at the start of physical therapy are associated with a 0.5 standard deviation (CID) improvement at the end of therapy

Does Physical Therapy Produce Value for Post-Operative and/or Non-Operative Foot and Ankle Patients?

Introduction/Purpose: Healthcare is at a unique time in history where patient reported outcomes have become important in assessing value and subsequent reimbursement with pay-4-performance initiatives. It is unclear whether physical function, pain and depressive symptoms can assist providers determine if additional physical therapy may improve care for foot and ankle patients considering post-op and/or non-operative care. The purpose of this research was to examine symptom severity (PROMIS PF, PI, and Dep) after surgery or with non-operative care at the start of formal physical therapy to determine if this symptom severity presentation and/or change in symptoms over time are predictors of improvement in physical function as assessed by PROMIS PF

Do Patient Sociodemographic Factors Impact the PROMIS Scores Meeting the Patient-Acceptable Symptom State at the Initial Point of Care in Orthopaedic Foot and Ankle Patients?

Background Patient-reported outcome measures such as the Patient-Reported Outcomes Measurement Information System (PROMIS) allow surgeons to evaluate the most important outcomes to patients, including function, pain, and mental well-being. However, PROMIS does not provide surgeons with insight into whether patients are able to successfully cope with their level of physical and/or mental health limitations in day-to-day life; such understanding can be garnered using the Patient-acceptable Symptom State (PASS). It remains unclear whether or not the PASS status for a given patient and his or her health, as evaluated by PROMIS scores, differs based on sociodemographic factors; if it does, that could have important implications regarding interpretation of outcomes and fair delivery of care. Questions/purposes In a tertiary-care foot and ankle practice, (1) Is the PASS associated with sociodemographic factors (age, gender, race, ethnicity, and income)? (2) Do PROMIS Physical Function (PF), Pain Interference (PI), and Depression scores differ based on income level? (3) Do PROMIS PF, PI, and Depression thresholds for the PASS differ based on income level? Methods In this retrospective analysis of longitudinally obtained data, all patients with foot and ankle conditions who had new-patient visits (n = 2860) between February 2015 and December 2017 at a single tertiary academic medical center were asked to complete the PROMIS PF, PI, and Depression survey and answer the following single, validated, yes/no PASS question: “Taking into account all the activity you have during your daily life, your level of pain, and also your functional impairment, do you consider that the current state of your foot and ankle is satisfactory?” Of the 2860 new foot and ankle patient visits, 21 patient visits (0.4%) were removed initially because all four outcome measures were not completed. An additional 225 patient visits (8%) were removed because the patient chart did not contain enough information to accurately geocode them; 15 patients visits (0.5%) were removed because the census block group median income data were not available. Lastly, two patient visits (0.1%) were removed because they were duplicates. This left a total of 2597 of 2860 possible patients (91%) in our study sample who had completed all three PROMIS domains and answered the PASS question. Patient sociodemographic factors such as age, gender, race, and ethnicity were recorded. Using census block groups as part of a geocoding method, the income bracket for each patient was recorded. A chi-square analysis was used to determine whether sociodemographic factors were associated with different PASS rates, two-way ANOVA analyses with pairwise comparisons were used to determine if PROMIS scores differed by income bracket, and a receiver operating characteristic (ROC) curve analysis was performed to determine PASS thresholds for the PROMIS score by income bracket. The minimum clinically important difference (MCID) for PROMIS PF in the literature in foot and ankle patients ranges from about 7.9 to 13.2 using anchor-based approaches and 4.5 to 4.7 using the ½ SD, distribution-based method. The MCID for PROMIS PI in the literature in foot and ankle patients ranges from about 5.5 to 12.4 using anchor-based approaches and about 4.1 to 4.3 using the ½ SD, distribution-based method. Both were considered when evaluating our findings. Such MCID cutoffs for PROMIS Depression are not as well established in the foot and ankle literature. Significance was set a priori at p \u3c 0.05. Results The only sociodemographic factor associated with differences in the proportion of patients achieving PASS was age (15% [312 of 2036] of patients aged 18-64 years versus 11% [60 of 561] of patients aged ≥ 65 years; p = 0.006). PROMIS PF (45 ± 10 for the ≥ USD 100,000 bracket versus 40 ± 10 for the ≤ USD 24,999 bracket, mean difference 5 [95% CI 3 to 7]; p \u3c 0.001), PI (57 ± 8 for ≥ USD 100,000 versus 63 ± 7 for ≤ USD 24,999, mean difference -6 [95% CI -7 to -4]; p \u3c 0.001), and Depression (46 ± 8 for the ≥ USD 100,000 bracket versus 51 ± 11 for ≤ USD 24,999, mean difference -5 [95% CI -7 to -3]; p \u3c 0.001) scores were better for patients in the highest income bracket compared with those in the lowest income bracket. For PROMIS PF, the difference falls within the score change range deemed clinically important when using a ½ SD, distribution-based approach but not when using an anchor-based approach; however, the score difference for PROMIS PI falls within the score change range deemed clinically important for both approaches. The PASS threshold of the PROMIS PF for the highest income bracket was near the mean for the US population (49), while the PASS threshold of the PROMIS PF for the lowest income bracket was more than one SD below the US population mean (39). Similarly, the PASS threshold of the PROMIS PI differed by 6 points when the lowest and highest income brackets were compared. PROMIS Depression was unable to discriminate the PASS. Conclusions Discussions about functional and pain goals may need to be a greater focus of clinic encounters in the elderly population to ensure that patients understand the risks and benefits of given treatment options at their advanced age. Further, when using PASS in clinical encounters to evaluate patient satisfaction and the ability to cope at different symptom and functionality levels, surgeons should consider income status and its relationship to PASS. This knowledge may help surgeons approach patients with a better idea of patient expectations and which level of symptoms and functionality is satisfactory; this information can assist in ensuring that each patient’s health goal is included in shared decision-making discussions. A better understanding of why patients with different income levels are satisfied and able to cope at different symptom and functionality levels is warranted and may best be accomplished using an epidemiologic survey approach. Level of Evidence Level III, diagnostic study

Pattern of Recovery and Outcomes of Patient Reported Physical Function and Pain Interference After Ankle Fusion: A Retrospective Cohort Study

Background: Research on outcomes after ankle fusion focuses on basic activities of daily living, fusion rates, and gait parameters. Little has been reported on the patient’s perspective after surgery. The purpose of this study was to determine the change in patient reported physical function and pain interference after ankle fusion surgery to guide patient expectations and improve provider communication. Methods: This was a retrospective review of prospectively collected patient reported outcome measurement information system (PROMIS) data in 88 ankle arthrodesis procedures performed from May 2015 to March 2018. The PROMIS Physical function (PF) and pain interference (PI) measures were collected as routine care. Linear mixed models were used to assess differences at each follow-up point for PF and PI. Preoperative to last follow-up in the 120–365 day interval was assessed using analysis of variance. Outcomes included T-scores, z-scores, and PROMISPreference (PROPr) utility scores for PF and PI and the percentage of patients improving by at least 4 T-score points. Results: The linear mixed model analysis for PF after the 120–149 days, and for PI, after 90–119 days, indicated recovery plateaued at 39–40 for PF and 57–59 for PI T-scores. The change in the PI T-score was the greatest with a mean T-score improvement of − 5.4 (95% CI − 7.7 to − 3.1). The proportion of patients improving more than 4 points was 66.2% for either PF or PI or both. The change in utility T-scores for both PF (0.06, 95% CI 0.02 to 0.11) and PI (0.15, 95% CI 0.09 to 0.20) was significantly improved, however, only PI approached clinical significance. Conclusion: Average patients undergoing ankle fusion experience clinically meaningful improvement in pain more so than physical function. Average patient recovery showed progressive improvement in pain and function until the four-month postoperative time point. Traditional dogma states that recovery after an ankle fusion maximizes at a year, however based on the findings in this study, 4 months is a more accurate marker of recovery. A decline in function or an increase in pain after 4 months from surgery may help to predict nonunion and other complications after ankle arthrodesis. Level of evidence: Level II, prospective single cohort study

Do Patient Reported Outcome Measurement Information System (PROMIS) Scales Demonstrate Responsiveness as Well as Disease-Specific Scales in Patients Undergoing Knee Arthroscopy?

Background: The Patient Reported Outcomes Information System (PROMIS) is an efficient metric able to detect changes in global health. Purpose: To assess the responsiveness, convergent validity, and clinically important difference (CID) of PROMIS compared with disease-specific scales after knee arthroscopy. Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: A prospective institutional review board–approved study collected PROMIS Physical Function (PF), PROMIS Pain Interference (PI), International Knee Documentation Committee (IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS) results in patients undergoing knee arthroscopy. The change from preoperative to longest follow-up was used in analyses performed to determine responsiveness, convergent validity, and minimal and moderate CID using the IKDC scale as the anchor. Results: Of the 100 patients enrolled, 76 were included. Values of the effect size index (ESI) ranged from near 0 to 1.69 across time points and were comparable across scales. Correlations of the change in KOOS and PROMIS with IKDC ranged from r values of 0.61 to 0.79. The minimal CID for KOOS varied from 12.5 to 17.5. PROMIS PF and PI minimal CID were 3.3 and 23.2. KOOS moderate CID varied from 14.3 to 18.8. PROMIS PF and PI moderate CID were 5.0 and 25.8. Conclusion: The PROMIS PF and PI showed similar responsiveness and CID compared with disease-specific scales in patients after knee arthroscopy. PROMIS PI, PROMIS PF, and KOOS correlations with IKDC demonstrate that these scales are measuring a similar construct. The ESIs of PROMIS PF and PI were similar to those of KOOS and IKDC, suggesting similar responsiveness at 6 months or longer (ESI .1.0). Minimum and moderate CID values calculated for PROMIS PF and PI using IKDC as an anchor were sufficiently low to suggest clinical usefulness. Clinical Relevance: PROMIS PF and PI can be accurately used to determine improvement or lack thereof with clinically important changes after knee arthroscopy

Determining Success or Failure After Foot and Ankle Surgery Using Patient Acceptable Symptom State (PASS) and Patient Reported Outcome Information System (PROMIS)

Background: As the role of generic patient-reported outcomes (PROs) expands, important questions remain about their interpretation. In particular, how the Patient Reported Outcome Measurement Instrumentation System (PROMIS) t score values correlate with the patients’ perception of success or failure (S/F) of their surgery is unknown. The purposes of this study were to characterize the association of PROMIS t scores, the patients’ perception of their symptoms (patient acceptable symptom state [PASS]), and determination of S/F after surgery. Methods: This retrospective cohort study contacted patients after the 4 most common foot and ankle surgeries at a tertiary academic medical center (n = 88). Patient outcome as determined by phone interviews included PASS and patients’ judgment of whether their surgery was a S/F. Assessment also included PROMIS physical function (PF), pain interference (PI), and depression (D) scales. The association between S/F and PASS outcomes was evaluated by chi-square analysis. A 2-way analysis of variance (ANOVA) evaluated the ability of PROMIS to discriminate PASS and/or S/F outcomes. Receiver operator curve (ROC) analysis was used to evaluate the ability of pre- (n = 63) and postoperative (n = 88) PROMIS scores to predict patient outcomes (S/F and PASS). Finally, the proportion of individuals classified by the identified thresholds were evaluated using chi-square analysis. Results: There was a strong association between PASS and S/F after surgery (chi-square \u3c0.01). Two-way ANOVA demonstrated that PROMIS t scores discriminate whether patients experienced positive or negative outcome for PASS (P \u3c .001) and S/F (P \u3c .001). The ROC analysis showed significant accuracy (area under the curve \u3e 0.7) for postoperative but not preoperative PROMIS t scores in determining patient outcome for both PASS and S/F. The proportion of patients classified by applying the ROC analysis thresholds using PROMIS varied from 43.0% to 58.8 % for PASS and S/F. Conclusions: Patients who found their symptoms and activity at a satisfactory level (ie, PASS yes) also considered their surgery a success. However, patients who did not consider their symptoms and activity at a satisfactory level did not consistently consider their surgery a failure. PROMIS t scores for physical function and pain demonstrated the ability to discriminate and accurately predict patient outcome after foot and ankle surgery for 43.0% to 58.8% of participants. These data improve the clinical utility of PROMIS scales by suggesting thresholds for positive and negative patient outcomes independent of other factors. Level of Evidence: II, prospective comparative series