Patient Reported Outcome Measurement Information System PROMIS Physical Function Scores Research Articles

Paper 48: Association of 3D MRI Volumetric Assessment of Rotator Cuff Pathology with Preoperative Patient Reported Outcomes

Paper 48: Association of 3D MRI Volumetric Assessment of Rotator Cuff Pathology with Preoperative Patient Reported Outcomes

The Responsiveness of the Patient-Reported Outcomes Measurement Information System Upper Extremity and Physical Function in Patients With Cubital Tunnel Syndrome

The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) and PROMIS Physical Function (PF) are increasingly referenced patient-reported outcomes. To interpret treatment effects with these patient-reported outcomes, investigators must understand magnitudes of change that represent clinically relevant improvement. This study assessed the responsiveness of PROMIS UE and PF in patients with cubital tunnel syndrome. A retrospective analysis of PROMIS UE and PROMIS PF computer adaptive test scores was performed for patients treated nonoperatively for cubital tunnel syndrome over 3 years at a tertiary institution. The Patient-Reported Outcomes Measurement Information System UE and PROMIS PF outcome scores were collected at initial and return clinic visits. At follow-up appointments, patients completed clinical anchor questions evaluating their degree of interval clinical improvement. Anchor questions allowed categorization of patients into groups that had experienced "no change," "minimal change," and "much change." Minimal clinically important difference (MCID) values were calculated for the PROMIS assessments with anchor-based and distribution-based methods. A total of 304 patients with PROMIS PF scores and 111 with PROMIS UE scores were analyzed. The MCID for the PROMIS UE was 3.1 (95% confidence interval, 1.4-4.8) using the anchor-based method and 3.7 (95% confidence interval, 2.9-4.4) using the distribution-based method. These point estimates exceeded the minimal detectable change of 2.3. The MCID for the PROMIS PF was unable to be determined in this patient sample because patients reporting mild change did not have score changes exceeding measurement error. The PROMIS UE v2.0 computer adaptive test detected minimal change in patients managed nonoperatively for cubital tunnel syndrome with an estimated MCID range of 3.1-3.7. While PROMIS PF has demonstrated acceptable performance in patients with a variety of upper extremity conditions, for cubital tunnel syndrome, it was less able to detect subtle change. PROMIS UE appears more responsive to subtle changes in cubital tunnel syndrome symptoms. Patient-reported outcomes may have varied responsiveness depending on the condition studied.

Association of Preoperative Physical Function and Changes in Mental Health After Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Few investigations have focused on the predictive value of Patient-Reported Outcomes Measurement Information System (PROMIS) scores, patient depression measured by the Patient Health Questionnaire-9 (PHQ-9), and their relationship in the setting of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). This study aims to detail the association between preoperative physical function with postoperative change in physical function and in depressive symptoms. A prospectively maintained surgical registry was retrospectively reviewed from March 2016 to February 2019. Inclusion criteria were primary, single-level MIS TLIF procedures. Multilevel procedures and patients without PROMIS or PHQ-9 were excluded. Patients were grouped by preoperative PROMIS score (<35.0 and ≥35.0), with higher scores indicating greater physical function. A t test analyzed differences between PROMIS subgroups for operative time (skin incision to closure), estimated blood loss, length of stay, and discharge day. A t test also assessed the difference in PROMIS Physical Function (PF) and PHQ-9. Linear regression evaluated the relationship between pre- and postoperative PROMIS and PHQ-9. Of 119 patients, 53.8% were male and 47.9% were obese. The mean ± SD age was 52.2 ± 10.7 years. The PROMIS <35.0 group had a larger improvement of PROMIS scores compared to the PROMIS ≥35.0 group at 6 weeks, 12 weeks, and 6 months. There was a negative association between preoperative PROMIS and PROMIS score improvement at 6 weeks, 12 weeks, and 6 months. For all time points, improvement in PHQ-9 was not associated with preoperative PROMIS scores. From 0 weeks to 6 months after MIS TLIF, patients with lower preoperative physical function had larger improvements in PROMIS PF scores. Preoperative function was not predictive of postoperative changes in PHQ-9. While relationships between mental and physical health cannot be discounted, the lack of PHQ-9 association with physical function demonstrates the impact that MIS TLIF can have, regardless of PROMIS PF score. Patients demonstrating lower levels of preoperative physical function may be in position for greater improvements in physical function following MIS TLIF surgery. In this study, there was no clear relationship between preoperative physical function levels and postoperative improvement in mental health, suggesting that all patients may achieve similar mental health improvement following MIS TLIF. 3.

Preoperative Physical Function Association With Mental Health Improvement After Anterior Cervical Discectomy and Fusion.

This was a retrospective study. This study investigates the influence of physical function and their influence on postoperative depressive symptom scores as measured by Patient Health Questionnaire-9 (PHQ-9) among anterior cervical decompression and fusion (ACDF) patients. While ACDF is one of the most commonly performed ambulatory surgeries, research is limited on the predictive value of Patient-Reported Outcomes Measurement Information System (PROMIS) scores and their influence on depressive symptoms as measured by the PHQ-9. A prospectively maintained surgical registry was retrospectively reviewed from March 2016 to January 2019. Inclusion criteria were primary or revision ACDF procedures. Patients were grouped by preoperative PROMIS score (≥35.0, <35.0), with higher scores indicating greater physical function. The χ2 and Student t tests assessed categorical and continuous variables (eg, demographics, perioperative, and postoperative values). A t test evaluated postoperative improvement in PROMIS Physical Function (PF) scores between subgroups among PROMIS PF scores and PHQ-9 score improvement at 6, 12 weeks, 6 months, and 1 year. Linear regression assessed preoperative PROMIS scores influence on PHQ-9 score improvement. The 121 subject cohort was 61.2% male with an average age of 49.6±9.8 years. Compared with the PROMIS ≥35.0 group, the PROMIS <35.0 group also had larger improvement of PROMIS scores at 6 weeks. No significant difference in postoperative PHQ-9 improvement was observed between subgroups. There was a negative association between preoperative PROMIS scores and improvement in PROMIS scores at 6, 12 weeks, 6 months, and 1 year. There was a positive association between preoperative PROMIS scores and magnitude of 1-year PHQ-9 change. Individuals with lower preoperative PROMIS PF scores had significantly higher PHQ-9 scores at 1 year. Patients with lower preoperative physical function, as evaluated by PROMIS PF scoring, had greater improvement of mental health at 1 year postoperatively. This suggests that many patients experience multidimensional health benefits after ACDF procedures.

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

Category:OtherIntroduction/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.Methods:The PROMIS PF scale was available at the start and end of physical therapy treatment for 352 patients with foot and ankle ICD10 codes. PF was chosen as a good outcome measure to assess overall outcome from physical therapy care. Changes from baseline to post-care were examine using Cohen’s d to remove dependence on sample size and was interpreted as d=0.20 as a small effect, d=0.05 as a medium effect, and d=0.80 as a large effect. Using available isotonic regression with linear interpolation functions, health state utility scores were calculated from the PROMIS PF scores. These scores represent a health state between 0, representing ‘being dead’, and 1 being the utility of ‘full health’. This methodology has been shown to be reliable and valid for assessing overall health quality of life from changes in physical function. Repeated measures ANOVA models were used to compare outcomes across time.Results:A significant improvement (p<0.01) in PF scores was seen across the sample following physical therapy (PF t-score; baseline 38.6+-8.8; follow-up 45+-9.1). This change was associated with a moderate to large ES of 0.75. The average ES for those subjects with a starting t-score less than 45 (n=294) was 0.86 (large effect) while for those with a starting t-score of greater than 45 (n=58) was 0.27 (small effect). There was also a significant (p<0.01) improvement in utility scores following physical therapy (utility score; baseline 0.58+-0.2; follow-up 0.72+-0.2).Conclusion:There is a general improvement in reported physical function following physical therapy but the magnitude of this effect depends on baseline function. Lower function is associated with greater changes. Improvement in physical function was associated with an overall improvement in quality of life. The non-linear nature of utility scores suggests some patients may have large increases in quality of life with small changes in physical function.

P115. Evaluation of PROMIS physical function in anterior cervical discectomy and fusion

BACKGROUND CONTEXT As Patient-Reported Outcomes Measurement Information System (PROMIS) becomes increasingly utilized, it is important to assess its validity procedure-specific populations. PURPOSE This study aims to evaluate the utility of PROMIS physical function (PF) domain as compared to legacy measures of patient reported outcomes (PROs) among patients undergoing an anterior cervical discectomy and fusion (ACDF). STUDY DESIGN/SETTING Retrospective. PATIENT SAMPLE A total of 57 patients undergoing a primary, 1-3 level ACDF. OUTCOME MEASURES PROMIS PF, NDI, VAS Neck and Arm, SF-12. METHODS Patients undergoing a primary, 1-3 level ACDF were retrospectively identified from a prospectively-maintained surgical registry. PROMIS PF and legacy PRO scores were obtained at preoperative and 6-week, 12-week, and 6-month postoperative visits. Legacy PROs included Neck Disability Index (NDI), Short Form-12 (SF-12) physical composite, Visual Analog Scale (VAS) neck pain and VAS arm pain. Postoperative improvements in PROs were assessed using paired t-tests. Correlations between PROMIS and legacy PROs were tested using Pearson correlation coefficient with strength of association interpreted as follows: |r|=0.1-0.3, weak; |r|=0.3-0.5, moderate; |r|=0.5-1.0, strong. RESULTS A total of 57 ACDF patients were included in this analysis. PROMIS PF scores significantly improved at 12 weeks and 6 months postoperatively, but not at 6 weeks. NDI, VAS neck pain, and VAS arm pain scores demonstrated significant improvement at all postoperative timepoints. SF-12 scores exhibited significant improvement at the 6-month follow up visit. Significant correlations between PROMIS PF and NDI and SF-12 were identified at all preoperative and postoperative timepoints. PROMIS PF exhibited strong correlations with VAS neck pain at postoperative timepoints and a moderate correlation preoperatively. CONCLUSIONS Patients undergoing a primary 1-3 level ACDF experience significant improvements in PROMIS PF scores at 12-week and 6-month postoperative visits, but not at 6-weeks. PROMIS PF exhibits strong correlations to NDI and SF-12 at all preoperative and postoperative timepoints. These results suggest that PROMIS PF accurately measures physical function and may be used in lieu of legacy physical function instruments for patients undergoing ACDF. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) scores with legacy patient-reported outcome scores in patients undergoing rotator cuff repair

The Patient-Reported Outcomes Measurement Information System (PROMIS) is being used to assess outcomes in many patient populations despite limited validation. The purpose of this study was to investigate the relationship between American Shoulder and Elbow Surgeons (ASES) and Simple Shoulder Test (SST) scores and PROMIS Physical Function (PF) and Upper Extremity (UE) function scores collected preoperatively in patients undergoing rotator cuff repair. This cross-sectional study analyzed 164 consecutive patients undergoing arthroscopic rotator cuff repair. Study inclusion required preoperative completion of the ASES and SST evaluations, as well as the PROMIS PF, UE, and Pain Interference computerized adaptive tests. Descriptive statistics were produced, and Pearson correlation coefficients were calculated between each of the outcome measures. Average PROMIS UE scores indicated greater impairment than PROMIS PF scores (34 vs 44). Three percent of patients reached the PROMIS UE ceiling score of 56. PROMIS PF scores demonstrated a weak correlation with ASES scores (r = 0.43, P < .001) and a moderate correlation with SST scores (r = 0.51, P < .001). PROMIS UE scores demonstrated a moderate correlation with both ASES scores (r = 0.59, P < .001) and SST scores (r = 0.62, P < .001). PROMIS Pain Interference scores demonstrated weak negative correlations with both ASES scores (r = -0.43, P < .001) and SST scores (r = -0.41, P < .001). Patients answered fewer questions on average using the PROMIS PF and UE instruments as compared with the ASES and SST instruments. PROMIS UE scores indicate greater impairment and demonstrate a stronger correlation with the legacy shoulder scores than PROMIS PF scores in patients with symptomatic rotator cuff tears. PROMIS computerized adaptive tests allow for more efficient patient-reported outcome data collection compared with traditional outcome scores.