PROMIS Pain Interference Scores Research Articles

Role of Insole Material in Treatment of Plantar Fasciitis: A Randomized Clinical Trial

BackgroundIn this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and Carbon Fiber insoles in the treatment of PF using a set of patient-reported outcomes. MethodsPatients were randomly allocated one of the three prefabricated insoles – Carbon Fiber (n=14), PU (n=14), or PE (n=17) for regular use. Their response was recorded using PROMIS 3a (for pain intensity), PROMIS 4a (for pain interference), FAOS (Foot and Ankle Outcome Score), and VAS for pain at baseline, two, six, and twelve weeks. ResultsThe PROMIS pain intensity scores improved in both the Carbon Fiber and the PE groups starting at the 6th week (p=0.04) and 2nd week (p=0.002), respectively. PROMIS pain interference scores also showed positive trends in these two groups (p=0.02, p=0.004, respectively). ConclusionPrefabricated Carbon Fiber and PE insoles showed significant pain-reducing effects in patients with PF. Levels of evidenceLevel I, Randomized controlled trial.

Socioeconomic Status Correlates With Initial Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) Scores but Not the Likelihood of Spine Surgery.

Objective To explore how socioeconomic status and patient characteristics may be associated with initial self-reports of pain and determine if there was an increased association with undergoing spine surgery. Methods Patients at an academic center between 2015 and 2021 who completed the Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) questionnaire were included. Multivariable linear regression models were used to determine the association between insurance type and patient factors with initial reports of pain. Multivariable logistic regression models were used to determine the association between PI and the likelihood of surgery in two time periods,three and 12 months. Results The study included 9,587 patients. The mean PROMIS-PI scores were 61.93 (SD 7.82) and 63.74 (SD 6.93) in the cervical and lumbar cohorts, respectively.Medicaidand Workers' Compensation insurance patients reported higher pain scores compared to those with private insurance: Medicaid (cervical: 2.77, CI (1.76-3.79), p<0.001; lumbar (2.05, CI (1.52-2.59), p<0.001); Workers' Compensation (cervical: 2.12, CI (0.96-3.27), p<0.001; lumbar: 1.51, CI (0.79-2.23), p<0.001). Black patients reported higher pain compared to White patients (cervical: 1.50, CI (0.44-2.55), p=0.01; lumbar: 1.51, CI (0.94-2.08), p<0.001). Higher PROMIS-PI scores were associated with a higher likelihood of surgery. There was no increased association of likelihood of surgery in Black, Medicaid, or Workers' Compensation patients when controlling for pain severity. Conclusion Black patients and patients with Medicaid and Workers' compensation insurance were likely to report higher pain scores. Higher initial pain scores were associated with an increased likelihood of surgery. However, despite increased pain scores, Black patients and those with Medicaid and Workers' Compensation insurance did not have a higher likelihood of undergoing surgery.

Recovery Curves for Lisfranc ORIF Using PROMIS Physical Function and Pain Interference.

To determine the postoperative trajectory and recovery of patients who undergo Lisfranc open reduction and internal fixation using Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI). Retrospective cohort study. Level 1 trauma center. Patients who underwent Lisfranc open reduction and internal fixation between January 2002 and December 2022 with documented PROMIS PF and/or PI scores after surgery. PROMIS PF and PI were mapped over time up to 1 year after surgery. A subanalysis was performed to compare recovery trajectories between high-energy and low-energy injuries. A total of 182 patients were included with average age of 38.7 (SD 15.9) years (59 high-energy and 122 low-energy injuries). PROMIS PF scores at 0, 6, 12, 24, and 48 weeks were 30.2, 31.4, 39.2, 43.9, and 46.7, respectively. There was significant improvement in PROMIS PF between 6 and 12 weeks ( P < 0.001), 12-24 weeks ( P < 0.001), and 24-48 weeks ( P = 0.022). A significant difference in PROMIS PF between high and low-energy injuries was seen at 0 week (28.4 vs. 31.4, P = 0.010). PROMIS PI scores at 0, 6, 12, 24, and 48 weeks were 62.2, 58.5, 56.6, 55.7, and 55.6, respectively. There was significant improvement in PROMIS PI 0-6 weeks ( P = 0.016). A significant difference in PROMIS PI between high-energy and low-energy injuries was seen at 48 weeks with scores of (58.6 vs. 54.2, P = 0.044). After Lisfranc open reduction and internal fixation, patients can expect improvement in PF up to 1 year after surgery, with the biggest improvement in PROMIS PF scores between 6 and 12 weeks and PROMIS PI scores between 0 and 6 weeks after surgery. Regardless the energy type, Lisfranc injuries seem to regain comparable PF by 6-12 months after surgery. However, patients with higher energy Lisfranc injuries should be counseled that these injuries may lead to worse PI at 1 year after surgery as compared with lower energy injuries. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

The Promising 2-Year Performance of the Patient-Reported Outcomes Measurement Information System in Primary Hip Arthroscopy for Femoroacetabular Impingement Syndrome

Background: Minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds have been previously defined for the Patient-Reported Outcomes Measurement Information System (PROMIS) at 1-year follow-up in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome; however, the MCID and PASS thresholds are yet to be defined for the PROMIS at 2-year follow-up. Purpose: (1) To establish MCID and PASS thresholds for the PROMIS Pain Interference (PROMIS-PI) and PROMIS Physical Function (PROMIS-PF) at 2-year follow-up and (2) to correlate PROMIS scores with hip-specific patient-reported outcome measure (PROM) scores. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Patients undergoing primary hip arthroscopy for femoroacetabular impingement syndrome between August and November 2020 with preoperative and minimum 2-year postoperative data were identified. Collected scores included those for the PROMIS-PI, PROMIS-PF, Hip Outcome Score–Activities of Daily Living (HOS-ADL), Hip Outcome Score–Sports Subscale (HOS-SS), International Hip Outcome Tool–12 (iHOT-12), and visual analog scale (VAS) for pain. MCID thresholds were calculated using the distribution-based method and PASS thresholds using the anchor-based method. Pearson correlation coefficients were used to compare scores between PROMs. Results: A total of 65 patients met the criteria for inclusion (72.3% female; mean age, 36.9 ± 13.5 years; mean body mass index, 26.2 ± 6.0). The mean follow-up was 25.3 ± 3.3 months. Significant preoperative to postoperative improvements were observed for all PROMs (P < .001). MCID thresholds and achievement rates were as follows: HOS-ADL, 10.1 and 75%, respectively; HOS-SS, 13.8 and 79%, respectively; iHOT-12, 14.0 and 67%, respectively; VAS pain, –13.8 and 78%, respectively; PROMIS-PI, –4.7 and 65%, respectively; and PROMIS-PF, 5.8 and 60%, respectively. PASS thresholds and achievement rates were as follows: HOS-ADL, 78.7 and 67%, respectively; HOS-SS, 76.4 and 62%, respectively; iHOT-12, 67.4 and 60%, respectively; VAS pain, 25.5 and 61%, respectively; PROMIS-PI, 57.0 and 65%, respectively; and PROMIS-PF, 45.6 and 58%, respectively. PROMIS-PI scores correlated most strongly with HOS-ADL (r = −0.836), HOS-SS (r = −0.767), and iHOT-12 (r = −0.719) scores and exhibited at least moderate correlations (r≥−0.595) with the other PROM scores. PROMIS-PF demonstrated moderate correlations with all the other PROM scores (r≥−0.586). Strong correlations were seen between the hip-specific PROM scores (r≥−0.745). Conclusion: This study defined 2-year MCID and PASS thresholds for the PROMIS-PI and PROMIS-PF and demonstrated moderate to strong correlations between PROMIS scores and hip-specific PROM scores.

Evaluation of Fluoroscopically Guided Transforaminal Selective Nerve Root Sleeve Injections for Lumbar Spinal Stenosis With Radiculopathy Utilizing Patient Reported Outcome Measurement Information System as an Outcome Measure

ObjectiveTo evaluate the therapeutic effect of transforaminal selective nerve root sleeve injections (TFSNRIs) in a specific subset of patients with clinical symptoms and presentation consistent with spinal stenosis. DesignRetrospective review. SettingTertiary academic spine center. ParticipantsA total of 176 patients with radicular leg pain with or without low back pain as well as ≥3 clinical features of spinal stenosis and corroborative radiographic features of spinal stenosis on lumbar spine magnetic resonance imaging without confounding spinal pathology (N=176). InterventionsFluoroscopically guided transforaminal selective nerve root sleeve injections. Main Outcome MeasuresPatient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) v1.2/v2.0, Pain Interference (PI) v1.1, and PROMIS (D) v1.0 were collected at baseline and post-procedure short term (<3-months) and long-term (6-12 month) follow-up. Statistical analysis comparing baseline and postprocedural PROMIS scores was performed. Differences were compared with previously established minimal clinically important differences in the spine population. ResultsFor patients with spinal stenosis treated with TFSNRI, no statistically significant improvement was observed short- and long-term follow-up in PROMIS PF (P=.97, .77) and PROMIS Depression (P=.86, .85) scores. At short-term follow-up, PROMIS PI scores did significantly improve (P=.01) but the average difference of pre- and post-procedure scores did not reach clinical significance. No significant difference in PROMIS PI was noted at long-term follow-up (.75). ConclusionsAlthough a statistically significant difference was observed for improvement in pain, in this retrospective study, TFSNRI did not provide clinically significant improvement in patients’ function, pain, or depression for lumbar spinal stenosis at short- and long-term follow-up.

Particulated Juvenile Articular Cartilage Allograft Transplantation for Patellofemoral Defects Shows Favorable Return-to-Sport Rates and Patient-Reported Outcomes

PurposeTo report return to sport rates, postoperative patient reported outcomes (PRO), complications, and reoperation rates of a cohort of patients undergoing particulated juvenile articulated cartilage (PJAC) allograft transplantation for patellofemoral articular cartilage defects. MethodsSingle-institution retrospective review from 2014 to 2022 was performed of all patients with patellofemoral articular cartilage defects who received PJAC allograft transplantation. Baseline demographics and surgical data, including concomitant surgeries performed, were collected. Clinical outcomes recorded included return to sport rates, complications, reoperations, and the following PRO scores: Kujala knee score, Patient Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI), and Physical Function (PROMIS-PF) scores. ResultsForty-one knees with a mean age of 23.4 ± 9.7 years and mean follow up of 30.3 months (range, 12 to 107 months) were included. The mean respective postoperative PROMIS-PI, PROMIS-PF, and Kujala knee scores were 47.4 ± 7.7, 52.2 ± 10.8, and 81.7 ± 16.1, reflecting low residual anterior knee pain and return to normal function. For patients playing organized sports at the high school and collegiate level, overall return to sport rate was 100% (17 out of 17). During follow up, 12 knees (29.3%) developed a complication, the most common of which was anterior-based knee pain, and 6 knees (14.6%) required a total of 8 reoperations, which occurred from 6 to 32 months postoperatively. ConclusionThe 100% return to sport rate and satisfactory PRO scores suggest that PJAC allograft transplantation can effectively address patellofemoral cartilage defects in many patients. The respective complication and reoperation rates of 29.3 and 14.6% are consistent with the challenging and heterogenic etiology and treatment of patellofemoral articular defects.

How Are Age, Gender, and Country Differences Associated With PROMIS Physical Function, Upper Extremity, and Pain Interference Scores?

The interpretation of patient-reported outcomes requires appropriate comparison data. Currently, no patient-specific reference data exist for the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF), Upper Extremity (UE), and Pain Interference (PI) scales for individuals 50 years and older. (1) Can all PROMIS PF, UE, and PI items be used for valid cross-country comparisons in these domains among the United States, the United Kingdom, and Germany? (2) How are age, gender, and country related to PROMIS PF, PROMIS UE, and PROMIS PI scores? (3) What is the relationship of age, gender, and country across individuals with PROMIS PF, PROMIS UE, and PROMIS PI scores ranging from very low to very high? We conducted telephone interviews to collect custom PROMIS PF (22 items), UE (eight items), and PI (eight items) short forms, as well as sociodemographic data (age, gender, work status, and education level), with participants randomly selected from the general population older than 50 years in the United States (n = 900), United Kingdom (n = 905), and Germany (n = 921). We focused on these individuals because of their higher prevalence of surgeries and lower physical functioning. Although response rates varied across countries (14% for the United Kingdom, 22% for Germany, and 12% for the United States), we used existing normative data to ensure demographic alignment with the overall populations of these countries. This helped mitigate potential nonresponder bias and enhance the representativeness and validity of our findings. We investigated differential item functioning to determine whether all items can be used for valid crosscultural comparisons. To answer our second research question, we compared age groups, gender, and countries using median regressions. Using imputation of plausible values and quantile regression, we modeled age-, gender-, and country-specific distributions of PROMIS scores to obtain patient-specific reference values and answer our third research question. All items from the PROMIS PF, UE, and PI measures were valid for across-country comparisons. We found clinically meaningful associations of age, gender, and country with PROMIS PF, UE, and PI scores. With age, PROMIS PF scores decreased (age ß Median = -0.35 [95% CI -0.40 to -0.31]), and PROMIS UE scores followed a similar trend (age ß Median = -0.38 [95% CI -0.45 to -0.32]). This means that a 10-year increase in age corresponded to a decline in approximately 3.5 points for the PROMIS PF score-a value that is approximately the minimum clinically important difference (MCID). Concurrently, we observed a modest increase in PROMIS PI scores with age, reaching half the MCID after 20 years. Women in all countries scored higher than men on the PROMIS PI and 1 MCID lower on the PROMIS PF and UE. Additionally, there were higher T-scores for the United States than for the United Kingdom across all domains. The difference in scores ranged from 1.21 points for the PROMIS PF to a more pronounced 3.83 points for the PROMIS UE. Participants from the United States exhibited up to half an MCID lower T-scores than their German counterparts for the PROMIS PF and PROMIS PI. In individuals with high levels of physical function, with each 10-year increase in age, there could be a decrease of up to 4 points in PROMIS PF scores. Across all levels of upper extremity function, women reported lower PROMIS UE scores than men by an average of 5 points. Our study provides age-, gender-, and country-specific reference values for PROMIS PF, UE, and PI scores, which can be used by clinicians, researchers, and healthcare policymakers to better interpret patient-reported outcomes and provide more personalized care. These findings are particularly relevant for those collecting patient-reported outcomes in their clinical routine and researchers conducting multinational studies. We provide an internet application ( www.common-metrics.org/PROMIS_PF_and_PI_Reference_scores.php ) for user-friendly accessibility in order to perform age, gender, and country conversions of PROMIS scores. Population reference values can also serve as comparators to data collected with other PROMIS short forms or computerized adaptive tests. Level II, diagnostic study.

Superior Outcomes with Reverse Shoulder Arthroplasty Versus Nonoperative Management for Proximal Humerus Fractures: A Matched Cohort Analysis.

To evaluate early outcomes (within 1 year) for geriatric proximal humerus fractures managed nonoperatively or with reverse shoulder arthroplasty (RSA). Retrospective cohort Setting: Academic level 1 trauma center, level 2 trauma/geriatric fracture centerPatients/Intervention: 71 patients with proximal humerus fractures that underwent nonoperative management or RSA, matched by age, comorbidity burden, and fracture morphology. Patient reported outcomes, range of motion, and complications rates within 1 year of treatment. RSA patients demonstrated greater active forward flexion (aFF) and external rotation compared to nonoperative patients throughout the first 6 months after treatment (p<0.05 for all). RSA patients achieved satisfactory ROM (>90° aFF) at higher rates than nonoperative patients (96.2% vs 62.2%, p<0.01). RSA led to significantly lower shoulder pain and PROMIS pain interference scores throughout the first year post-treatment (p<0.05). PROMIS physical function scores were also higher in the RSA group at 3 months, 6 months, and 1 year compared to the nonoperative group (p<0.05 for all). Similar complication rates were experienced in both groups (nonoperative=8.9%, RSA=7.7%; p=0.36). In an age, comorbidity and fracture morphology matched analysis, treatment of proximal humerus fractures with RSA is associated with greater shoulder ROM throughout the first 6 months of treatment, decreased pain, and improved physical function compared to nonoperative management, without significant differences in short term complications. These results suggest that RSA may be superior to nonoperative management during the early recovery period for proximal humerus fractures. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A Longitudinal Investigation of the Impact of COVID-19 on Patients With Chronic Pain

The COVID-19 pandemic prompted unexpected changes in the healthcare system. This current longitudinal study had 2 aims: 1) describe the trajectory of pandemic-associated stressors and patient-reported health outcomes among patients receiving treatment at a tertiary pain clinic over 2 years (May 2020 to June 2022); and 2) identify vulnerable subgroups. We assessed changes in pandemic-associated stressors and patient-reported health outcome measures. The study sample included 1270 adult patients who were predominantly female (74.6%), White (66.2%), non-Hispanic (80.6%), married (66.1%), not on disability (71.2%), college-educated (59.45%), and not currently working (57.9%). We conducted linear mixed effect modeling to examine the main effect of time with controlling for a random intercept. Findings revealed a significant main effect of time for all pandemic-associated stressors except financial impact. Over time, patients reported increased proximity to COVID-19, but decreased pandemic-associated stressors. A significant improvement was also observed in pain intensity, pain catastrophizing, and PROMIS-pain interference, sleep, anxiety, anger, and depression scores. Demographic-based subgroup analyses for pandemic-associated stressors revealed that younger adults, Hispanics, Asians, and patients receiving disability compensation were vulnerable groups either during the initial visit or follow-up visits. We observed additional differential pandemic effects between groups based on participant sex, education level, and working status. In conclusion, despite unanticipated changes in pain care services during the pandemic, patients receiving pain treatments adjusted to pandemic-related stressors and improved their health status over time. As the current study observed differential pandemic impacts on patient subgroups, future studies should investigate and address the unmet needs of vulnerable subgroups. PerspectiveOver a 2-year timeframe, the pandemic did not adversely influence physical and mental health among treatment-seeking patients with chronic pain. Patients reported small but significant improvements across indices of physical and psychosocial health. Differential impacts emerged among groups based on ethnicity, age, disability status, gender, education level, and working status.

Defining the minimal clinically important difference in smartphone-based mobility after spine surgery: correlation of survey questionnaire to mobility data.

Patient-reported outcome measures (PROMs) are the gold standard for assessing postoperative outcomes in spine surgery. However, PROMs are also limited by the inherent subjectivity of self-reported qualitative data. Recent literature has highlighted the utility of patient mobility data streamed from smartphone accelerometers as an objective measure of functional outcomes and complement to traditional PROMs. Still, for activity-based data to supplement existing PROMs, they must be validated against current metrics. In this study, the authors assessed the relationships and concordance between longitudinal smartphone-based mobility data and PROMs. Patients receiving laminectomy (n = 21) or fusion (n = 10) between 2017 and 2022 were retrospectively included. Activity data (steps-per-day count) recorded in the Apple Health mobile application over a 2-year perioperative window were extracted and subsequently normalized to allow for intersubject comparison. PROMS, including the visual analog scale (VAS), Patient Reported Outcome Measurement Information System Pain Interference (PROMIS-PI), Oswestry Disability Index (ODI), and EQ-5D, collected at the preoperative and 6-week postoperative visits were retrospectively extracted from the electronic medical record. Correlations between PROMs and patient mobility were assessed and compared between patients who did and those who did not achieve the established minimal clinically important difference (MCID) for each measure. A total of 31 patients receiving laminectomy (n = 21) or fusion (n = 10) were included. Change between preoperative and 6-week postoperative VAS and PROMIS-PI scores demonstrated moderate (r = -0.46) and strong (r = -0.74) inverse correlations, respectively, with changes in normalized steps-per-day count. In cohorts of patients who achieved PROMIS-PI MCID postoperatively, indicating subjective improvement in pain, there was a 0.784 standard deviation increase in normalized steps per day, representing a 56.5% improvement (p = 0.027). Patients who did achieve the MCID of improvement in either PROMIS-PI or VAS after surgery were more likely to experience an earlier sustained improvement in physical activity commensurate to or greater than their preoperative baseline (p = 2.98 × 10-18) than non-MCID patients. This study demonstrates a strong correlation between changes in mobility data extracted from patient smartphones and changes in PROMs following spine surgery. Further elucidating this relationship will allow for more robust supplementation of existing spine outcome measure tools with analyzed objective activity data.

Defining numerical cut points for mild, moderate, and severe pain in adult burn survivors: A northwest regional burn model system investigation

IntroductionPain is a common and often debilitating sequela of burn injury. Burn pain develops following damage to peripheral sensory nerves and the release of inflammatory mediators from injury. Burn pain is complex and can include background and procedural pain that result from the injury itself, wound care, stretching, and surgery. Clinicians and researchers need valid and reliable pain measures to guide screening, treatment, and research protocols. Unlike other conditions, visual analog, or numeric pain rating scale (VAS/NRS) scores that represent mild, moderate, and severe pain among people with burn injury have not been established. The aim of this study was to identify the most suitable average pain intensity rating scores for mild, moderate, and severe pain in adult burn survivors using a PROMIS Pain Interference (PROMIS-PI) short form. MethodsAn average pain intensity VAS/NRS score (0−10) and customized PROMIS-PI short form were administered to adults with burn injury treated at a regional burn center at hospital discharge (baseline) and at 6, 12, and 24-months after injury. To identify pain intensity scores that represent mild, moderate, and severe pain, we computed F values and Bayesian Information Criterion (BIC) statistics associated with multiple ANOVA comparisons for mean pain interference scores by various pain intensity cut points. Six possible cut points (CP) were compared: CP 3,6; 3,7; 4,6; 4,7; 2,5; and 3,5. Optimal cut points were considered those with the highest ANOVA F statistics. Models with similar F statistics were also compared with BIC. ResultsData from a sample of 253 participants (83% white, 66% male, mean age 47 years) with VAS/NRS pain intensity and PROMIS-PI scores at one or more timepoints were analyzed. The optimal classification for mild, moderate, and severe pain was CP 2,5 at baseline and 12-months. Although CP 3,6 had the highest F value at 6-months, there was not strong evidence to support CP 3,6 over CP 2,5 (BIC difference: 2.9); similarly, CP 3,7 had the highest value at 24-months, but the BIC difference over CP 2,5 was only 2.2. ConclusionsVAS/NRS scores for pain among adults with burn injury can be categorized as mild (0−2), moderate (3−5), and severe (6−10). These findings advance our understanding regarding the meaning of pain intensity ratings after burn injury, and provide an objective definition for clinical management, quality improvement, and pain research.

What are the Minimum Clinically Important Difference Values for the PROMIS and QuickDASH After Carpal Tunnel Release? A Prospective Cohort Study.

To better define the clinical significance of patient-reported outcomes, the concept of a minimum clinically important difference (MCID) exists. The MCID is the minimum change that a patient will perceive as meaningful. Prior attempts to determine the MCID after carpal tunnel release are limited by methodologic concerns, including the lack of a true anchor-based MCID calculation. To address previous methodologic concerns in existing studies, as well as establish a clinically useful value for clinicians, we asked: What are the MCID values for the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE), PROMIS Pain Interference (PI), and the QuickDASH after carpal tunnel release? We conducted a prospective cohort study at an urban, Midwest, multihospital, academic health system. One hundred forty-seven adult patients undergoing unilateral carpal tunnel release between September 2020 and February 2022 were identified. PROMIS UE, PI, and QuickDASH scores were collected preoperatively and 3 months postoperatively. We also collected responses to an anchor-based question: "Since your treatment, how would you rate your overall function?" (much worse, worse, slightly worse, no change, slightly improved, improved, or much improved). Patients who did not respond to the 3-month postoperative surveys were excluded. A total of 122 patients were included in the final analysis (83% response proportion [122 of 147]). The mean age was 57 years (range 23 to 87 years), and 68% were women. The MCID was calculated using both anchor-based and distribution-based methods. Although anchor-based calculations are generally considered more clinically relevant because they consider patients' perceptions of improvement, an estimation of the minimum detectable change (which represents measurement error) relies on a distribution-based calculation. We determined a range of MCID values to propose a final MCID value for all three instruments. A negative MCID value for the PROMIS PI instrument represents a decrease in pain, whereas a positive value for the PROMIS UE instrument represents an improvement in function. A negative value for the QuickDASH instrument represents an increase in function. The final proposed MCID values were 6.2 (interquartile range [IQR] 5.4 to 9.0) for the PROMIS UE, -7.8 (IQR -6.1 to -8.5) for the PROMIS PI, and -18.2 (IQR -13.3 to -34.1) for the QuickDASH. We recommend that clinicians use the following values as the MCID after carpal tunnel release: 6 for the UE, -8 for the PI, and -18 for the QuickDASH. Surgeons may find these values useful when counseling patients postoperatively regarding improvement. Future studies could examine whether a single MCID (or small range) for PROMIS instruments is applicable to a variety of conditions and interventions. Level II, therapeutic study.

Can Patient Reported Outcomes be Used to Eliminate Unnecessary Follow Up Clinic Visits after Surgery?

Category: Other; Ankle; Hindfoot; Midfoot/Forefoot Introduction/Purpose: Patient reported outcomes (PROs) have been a powerful tool to inform clinicians on the success or failure of various treatments including surgery. Patient-Reported Outcome Measurement Information System (PROMIS) is a suite of validated symptom-based questions designed to be asked and answered directly by the patient to track treatment progress quickly and accurately. This study uses PROMIS to determine the duration between foot and ankle surgery and assessment of a successful outcome. Additionally, we retrospectively calculate the savings that would be realized by eliminating unnecessary office visits if this model was implemented in clinical practice. Methods: Retrospective PROMIS Pain Interference (PI) data were obtained for common elective foot (n=832) and ankle (n=851) surgical procedures. Patients were categorized into quartiles of their pre-operative PI score - quartile 1 (Q1) being 25% of patients with the lowest PI scores. Minimal clinically important difference (MCID) was defined by the ½ standard-deviation of the pre- operative pain interference t-scores. A patient was considered recovered after observing two consecutive MCID decreases in post-operative pain interference t-scores. A cox proportional hazards model stratified by preoperative PI score quartile was used to predict probability patient recovery after adjusting for age, race, ethnicity, gender, and primary payor. The average and total potential savings for the cohort was derived using the number of patient-visits post-recovery. Results: Two consecutive decreases in MCID measured by PI PROMIS t-scores were achieved 90 days post-operatively by 16%, 16%, 17%, and 23% of post-operative ankle patients in quartiles 1-4 respectively; post-operative foot patients achieved 18%, 11%, 20%, and 26% in quartiles 1-4 respectively (see Figure 1). Days 30-60 recorded the greatest rate of improvement across quartiles with Q4 showing the greatest improvement. The least improvement occurred between days 90-120 across all quartiles. Patients were seen by the orthopedics departments on average 2.84 times after achieving two consecutive MCID improvements, totaling to $243.63 in expenses to institutional payers per patient. Avoiding these excess visits even after MCID achievement could result in savings ranging from $38,593 to $122,002. Conclusion: PI PROMIS t-scores can be used to assess the need for ongoing follow up for surgical patients. If there is evidence that the patient has improved a clinically meaningful amount on two successive visits additionally follow-up may not be needed. Using PROs in clinical decision-making pathways as suggested in this research will eliminate unnecessary visits and save healthcare dollars and valuable resources

Syndesmotic Injury in Tibial Plafond Fractures Is Associated With Worse Patient Outcomes.

To present long-term patient-reported outcomes of tibial plafond fractures with and without concomitant ankle syndesmotic injury. Retrospective cohort study. Academic Level 1 trauma center. One hundred ninety-seven patients with tibial plafond fractures (OTA/AO 43-B and 43-C) treated with definitive surgical fixation were contacted by telephone or email to obtain patient-reported outcome scores at a minimum follow-up of 1 year. Of those contacted, 148 (75%) had an intact syndesmosis, whereas 49 (25%) experienced a syndesmotic injury. The intervention involved open reduction internal fixation of the tibial plafond with syndesmosis repair when indicated. The main outcome measurement included patient-reported ankle pain and function using Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and physical function (PF). The cohort including patients with syndesmotic injury had significantly more open fractures (syndesmotic injury = 39%, no syndesmotic injury = 16%, P = 0.001), higher rates of end-stage reconstruction (syndesmotic injury = 27%, no syndesmotic injury = 10%, P = 0.004), and worse PROMIS PF (syndesmotic injury = 42.5 [SD = 8.0], no syndesmotic injury = 47.1 [SD = 9.6], P = 0.045) scores at final follow-up when compared with the cohort comprising patients with no syndesmotic injury. Patients with syndesmotic injury trended toward higher rates of postoperative infection, but this association was not statistically significant. There was no difference between the groups in nonunion or PROMIS pain interference scores. Patients with a tibial plafond fracture and concomitant syndesmotic injury had significantly worse PROMIS PF scores, more end-stage ankle reconstructions, and more open fractures. Syndesmotic injury in the setting of tibial plafond fractures portends worse patient outcomes. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

44. Does recall bias exist in lumbar spine surgery patients as reported through PROMIS questionnaires?

<h3>BACKGROUND CONTEXT</h3> Surgical outcomes are increasingly judged on patients' perceptions of the results. Despite the improved quantitative data provided by patient-reported outcomes (PROs), they remain susceptible to confounding factors on patients' interpretations such as recall bias: the inability to accurately recall prior impairment. No studies to date have reported the accuracy of patient recall using PROMIS outcomes after lumbar spine surgeries. <h3>PURPOSE</h3> The purpose of this study is to determine the presence and extent of recall bias in adult patients after elective lumbar spine surgery. <h3>STUDY DESIGN/SETTING</h3> Subgroup analysis of ongoing prospective study. <h3>PATIENT SAMPLE</h3> This study included 98 patients who had undergone either lumbar decompression or lumbar decompression and fusion procedures. <h3>OUTCOME MEASURES</h3> Baseline preoperative PROMIS Physical Function (PF), PROMIS Pain Interference (PI) and recalled preoperative PROMIS PF and PI. <h3>METHODS</h3> Patients, at least 2 years after their index surgery, completed a recall questionnaire comprised of the PF CAT and PI CAT as though it was a time immediately before their surgery. All patients had prospectively completed PROMIS PF CAT and PI CAT prior to surgery and at 3 months, 6 months, 1 year and 2 years. T tests were used to compare recalled PROs with actual baseline PROs. Correlation coefficients were calculated to evaluate the agreement between recalled PROs and baseline PROs. Regression analysis was performed to determine the impact of patient characteristics or clinical factors. <h3>RESULTS</h3> Patient recollection of preoperative status at a minimum of 2 years postoperatively was significantly more severe than baseline preoperative status with mean difference in PF of -1.5 (p < 0.05) and PI of 2.1 (p < 0.01). There was only moderate correlation between recalled and baseline scores with regards to PF (r=0.52) and PI (r=0.38). No significant differences on recalled PROs were found based on age, gender, time between surgery and recalled outcomes, and duration of symptoms before surgery. <h3>CONCLUSIONS</h3> Our data indicate that patient recall of preoperative status after lumbar surgery is significantly different than actual baseline preoperative status as measured by PROMIS PF and PI scores with only moderate correlation existing between the two. Patients' interpretations of improvement after surgery may be impacted by significant recall bias. This may have an impact on patient satisfaction and perceived value of lumbar spine surgery. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

127. Quantitative prospective patient-reported expectations (PREs) challenge commonly used thresholds for minimal clinically important difference (MCID) in elective spine surgery

<h3>BACKGROUND CONTEXT</h3> Patients make decisions about elective spine surgery based on perceptions of severity of the preoperative condition as well as expectations that surgery will improve symptoms, function and/or quality of life. As a result, spine surgery has increasingly focused on patient-reported outcomes (PROs) to measure results with thresholds such as minimal clinically important difference (MCID) used to define clinical success and failure. Despite the importance given, MCID values and methodology vary widely in the reported literature, are retrospectively assessed and do not account for individual patient preference at the time of surgical decision-making. No study to date has utilized PROMIS measures to prospectively define patients' expectations for improvement after surgery and compared them to commonly reported MCID values. <h3>PURPOSE</h3> To compare prospectively obtained, PROMIS-based patient-reported expectations (PREs) to commonly reported MCID values. <h3>STUDY DESIGN/SETTING</h3> Prospective observational cohort study. <h3>PATIENT SAMPLE</h3> Forty-five patients who underwent surgical decompression or decompression and fusion for cervical or lumbar degenerative spine pathology were included. <h3>OUTCOME MEASURES</h3> Baseline preoperative PROMIS Physical Function (PF), PROMIS Pain Interference (PI) and expected postoperative PROMIS PF and PI. <h3>METHODS</h3> Patients undergoing elective spine surgery were consecutively and prospectively identified. PROMIS questionnaires were administered at the first preoperative appointment to assess baseline preoperative PROMIS score and expected postoperative PROMIS score using the following domains: Physical Function (PF) and Pain Interference (PI). Baseline preoperative PROMIS scores were based on the symptoms they were experiencing at the preoperative time point. Patient-reported expectations (PREs) after surgery were determined by asking patients to respond to the same questionnaires by indicating the outcomes they were expecting following surgery. T-tests were used to compare expected postoperative PROMIS scores and baseline preoperative PROMIS scores for both PF and PI. Commonly reported anchor MCID values (8) for these PROMIS measures were obtained from a review of the literature. Regression analysis was performed to determine the impact of patient characteristics or clinical factors. Patients are still being followed out to 12 months to obtain long-term PROMIS outcomes and patient satisfaction results as well as to assess how expectations change over time. These results are not available at the time of abstract submission. <h3>RESULTS</h3> When comparing baseline preoperative PROMIS scores to expected postoperative PROMIS scores, patients expected to improve postoperatively in both PF and PI from baseline with mean difference 5.6 (p <0.001) and -5.9 (p <0.001), respectively. No significant differences for expected postoperative PROMIS scores were found based on age, sex, BMI, ASA classification, procedure or diagnosis. All expected improvements were less than the commonly used anchor MCID of 8. <h3>CONCLUSIONS</h3> This study is the first to compare prospectively collected, PROMIS-based patient expectations before elective spine surgery to established MCID values. Patient-reported expectations (PREs) are significantly different than actual baseline preoperative status as measured by PROMIS PF and PI scores. Patients' expectations are less than the commonly reported MCID of 8, challenging currently accepted standards of success and failure after elective spine surgery. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

What PROMIS Scores Correlate With Severe Disability in Cervical Spine Surgery?

Institutional Review Board-approved prospective cohort study. To establish a conversion between Neck Disability Index (NDI) and Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI). As the National Institutes of Health (NIH) PROMIS is a global outcome measure, it can be difficult to interpret the clinical implications in patients with cervical spine surgery. To determine how a disease-specific legacy instrument (NDI) correlates with PROMIS PI and define levels of substantial and minimal disability, we developed a formula to convert NDI scores to PROMIS PI. Adult patients undergoing cervical spine surgery at a single institution from 2016 to 2018 were prospectively enrolled. Patients undergoing surgery for instability due to trauma were excluded. Preoperative questionnaires, demographic data, presenting complaint (radiculopathy, myelopathy, myeloradiculopathy), and procedural data were recorded. Patients were included if they had completed the NDI and PROMIS PI. Correlation and regression analyses were performed. One hundred ninety-six patients met inclusion criteria. The average age was 56.9±12.9 years. The mean NDI score was 68.6±38 and PROMIS PI was 60.9±7.3. The PROMIS PI was strongly correlated with the NDI ( r =0.76, P <0.001). Linear regression analysis revealed the following formula. We performed a regression analysis allowing for the conversion of PROMIS PI scores with NDI. In keeping with the previous studies, our analysis showed that PROMIS PI was most strongly correlated to NDI. A PROMIS PI score >66 was correlated to substantial disability (NDI=50), whereas a PROMIS PI score <59 was correlated to minimal relative impairment (NDI=28). These results provide important reference, as PROMIS reporting becomes more widespread in the literature.

Changes in Patient-Reported Pain Interference After Surgical Treatment of Painful Lower Extremity Neuromas

Painful neuromas commonly cause neuropathic pain, in up to 1 in 20 cases of traumatic or iatrogenic nerve injury. Despite the multiple surgical treatment types that reduce pain, no type has been universally accepted. We performed a retrospective cohort study by administering follow-up surveys to all surgical patients treated in our department for lower-extremity neuroma from September 1, 2015, to October 22, 2021, that could be contacted, excluding those with Morton neuroma. In addition to the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) questionnaire, survey questions covered the time to pain reduction, use of physical or occupational therapy, and characteristics of the pain. When available, previously collected preoperative and postoperative PROMIS PI data were used for patients who could not be contacted for the telephone survey. Paired-sample nonparametric testing was used to compare preoperative and postoperative PROMIS PI scores. Initial query in the medical record by Current Procedural Terminology codes yielded 1,812 patients for chart review, of whom 33 were eligible to call. In total, 9 (27%) patients completed bothpreoperative and postoperative PROMIS PIs: 6 (18.2%) completed full telephone surveys and 3(9.1%) had preoperative and postoperative PROMIS PI data in the chart review but could not becontacted for the full telephone survey. Four of the 6 telephone-survey respondents reported painreduction within 12 months of their surgery. Wilcoxon signed-rank testing demonstrated a moderate but nonstatistically significant reduction in PROMIS PI scores, with a median difference of-4.85 (P= .1;95% CI -12 to 1.2). There were notable improvements in our cohort, but larger studies are needed to determine whether surgical treatment of lower-extremity neuroma results in a clinically important and significant difference in PROMIS PI scores, as well as to discern the advantages each treatment. Therapeutic IV.

Characterizing preoperative expectations for patients undergoing reverse total shoulder arthroplasty.

There remains a paucity of information analyzing which factors most influence preoperative expectations for patients undergoing reverse total shoulder arthroplasty (RTSA). The purposes of our study were to characterize preoperative patient expectations for those scheduled to undergo RTSA and to determine the impact of demographic factors, shoulder function, and shoulder pain on these preoperative expectations. Patients were prospectively recruited into the study if they were scheduled to undergo an elective unilateral primary RTSA for a diagnosis of glenohumeral arthritis. Preoperative patient expectations were evaluated using the Hospital for Special Surgery's Shoulder Surgery Expectation Survey. Patients also completed the American Shoulder and Elbow Surgeons shoulder score, the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function-Upper Extremity computer adaptive test (version 2.0), the PROMIS Pain Interference (PI) computer adaptive test (version 1.1), the PROMIS Depression computer adaptive test (version 1.0), visual analog scores, and an itemized satisfaction questionnaire, which paralleled the Hospital for Special Surgery's Shoulder Surgery Expectation Survey. Demographic data and preoperative shoulder range of motion (ROM) were also recorded. A total of 107 patients scheduled to undergo RTSA were included in the study. Relief of daytime pain (n = 91, 85%), improvement in self-care (n = 86, 80%), and improvement in shoulder ROM (n = 85, 79%) were most commonly cited as "very important" expectations. In the item-specific analysis, lower PROMIS Upper Extremity scores were correlated with greater expectations for the ability to reach sideways (P = .015) and the ability to perform daily activities (P = .018). Patients with lower shoulder ROM had greater expectations for improved shoulder ROM (internal rotation with arm at 90°, P = .004) and an improved ability to perform daily activities (forward elevation, P = .038; abduction, P = .009). In the cumulative analysis, a greater number of very important expectations was associated with African American race (P = .013), higher PROMIS PI score (r = 0.351, P = .004), and lower overall preoperative satisfaction (r = 0.334, P < .001). Patients scheduled to undergo RTSA have the greatest expectations for relief of daytime pain, improvement in self-care, and improvement in shoulder ROM. Patients with limited preoperative ROM have greater expectations for improvement in self-care and the ability to perform daily activities in addition to expectations for improvement in shoulder ROM. Greater overall expectations for surgery were not associated with preoperative physical function but were instead associated with lower preoperative satisfaction and higher PROMIS PI scores.

Patient Perception of Being “Completely Better” After Anterior Cruciate Ligament Reconstruction

Background: Contextualizing patient-reported outcomes (PROs) by defining clinically relevant differences is important. Considering that anterior cruciate ligament reconstruction (ACLR) ideally results in the restoration of normal knee function, an assessment of patients’ perception of being “completely better” (CB) may be of particular value. Purpose: The purpose of this study was to assess the prevalence and characteristics of patients who self-report a CB status after ACLR. Additionally, we aimed to determine whether PROs were associated with a CB status after ACLR as well as to determine CB status thresholds for 2-year and change in values. Study Design: Case-control study; Level of evidence, 3. Methods: We retrospectively analyzed data from an orthopaedic registry at a single institution. Patients were administered the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), PROMIS Pain Interference (PI), and International Knee Documentation Committee (IKDC) Subjective Knee Form preoperatively and at 2 years after ACLR. Additionally, patients completed a CB anchor question at 2 years after ACLR. Thresholds for 2-year and change in PRO scores associated with achieving a CB status were identified with 90% specificity. Results: Overall, 95 of the 136 patients (69.9%) considered their condition to be CB at 2 years after surgery. The 2-year and change in PROMIS PF, PROMIS PI, and IKDC scores were significantly better in the CB group than in the non-CB group. Thresholds associated with a CB status for 2-year PROMIS PF, PROMIS PI, and IKDC scores were more reliable than those for changes in scores and were ≥63, ≤44, and ≥80, respectively. Thresholds for the change in PROMIS PF, PROMIS PI, and IKDC scores were ≥19, ≤–16, and ≥44, respectively. Conclusion: The majority of patients reported that they were CB at 2 years after ACLR. This study may serve as a reference for orthopaedic surgeons and researchers when considering outcomes after ACLR.