Trajectory of Recovery Following Total Ankle Arthroplasty Using Patient-Reported Outcomes Measurement Information System (PROMIS)

Total ankle arthroplasty (TAA) is a common method of treatment for end-stage ankle arthritis (ESAA). The utilization of Patient-Reported Outcomes Measurement Information System (PROMIS) allows for standardized assessment of patient-driven outcomes, but few studies have been published on outcomes of TAA using PROMIS. The purpose of this study was to describe the recovery trajectory of patients undergoing TAA for ESAA for up to 1 year after surgery using PROMIS scores for physical function (PF), pain interference (PI), and depression (DP). A retrospective review of patients undergoing TAA for ESAA over a 5-year period (January 2018-October 2023) was performed. Preoperative and postoperative PROMIS scores were collected and compared at multiple time points leading up to 1 year after surgery. Demographic variables were compared. All patients included in this study underwent primary TAA. Patients were excluded from this study if they had contralateral TAA within 1 year of the previous TAA, and/or they did not have 1 preoperative or at least 2 postoperative PROMIS scores. In total, 109 patients met inclusion criteria with a mean age of 65.3 (SD 9.2) years. No patients undergoing TAA had Medicaid and 50% had Medicare. The mean PROMIS PF scores at 1, 3, 6 months and 1 year were 28.2, 38.5, 41.8, and 43.1, respectively. The mean PROMIS PI scores at 1, 3, 6 months and 1 year were 57.1, 59.2, 56.2, and 55.8, respectively. Most of the improvement for both PF and PI scores from preoperative occurred within the first 6 months of recovery, with average improvements of 5.0 points for PF and -8.4 points for PI. Patients had statistically and clinically significant improvements in PROMIS scores at multiple postoperative time points. Patients had statistically significant improvement in PROMIS scores through various time points in their recovery. This study demonstrates that patients who underwent primary TAA have improvements in PROMIS scores at several different time points up to 1 year after surgery. Patients can expect an improvement in pain and function from baseline within 3 months from surgery. Most improvements occur within the first 6 months. More than half of the patients will achieve a PF and PI score within 1 SD of the national average by 6 months, but it can take up to a year for most patients to reach this. Understanding the trajectory of patient recovery at different time points after primary TAA can help set patient expectations and guide intervention.

Are There Differences in Patient-Reported Outcomes Measurement Information System Scores After Total Knee and Total Ankle Arthroplasty in Matched Patients?

What's New in Foot and Ankle Surgery.

This study evaluates patient reported outcome measurement information system (PROMIS) scores after total hip arthroplasty (THA) and total ankle arthroplasty (TAA) in matched cohorts, while simultaneously evaluating implant survivorship and 90-day hospital utilization. It is hypothesized that while both procedures would yield similar PROMIS score improvements, THA would demonstrate superior mid-term implant survivorship.Primary THA and TAA patients from 2015–2022 with minimum one-year follow-up were retrospectively reviewed. After applying exclusion criteria, 2,092 THAs and 478 TAAs were included for analysis. Demographics, pre- and post-operative patient reported outcome measures (PROMs), revision surgeries, ED visits, and re-admissions were collected. THA and TAA patients were then propensity score matched at 2:1 ratio for age, sex, race, BMI, ASA, and comorbidities, resulting in a final cohort of 844 THAs and 455 TAAs for comparison.There were similar pre-operative PROMIS Pain Interference (PI) scores between THA and TAA, with both showing improvement at six weeks. However, THA patients exhibited lower PI scores at one year (53.0 versus 54.0; p=0.009). Pre-operative PROMIS Physical Function (PF) was worse in THA patients but showed greater improvement compared to TAA patients at both six weeks (p<0.001) and one year (p<0.001). Pre-operative PROMIS depression scores were similar and improved similarly in both groups. Joint-specific PROMs (HOOS for THA and FAAM for TAA) improved in both cohorts. THA demonstrated superior survivorship free of all-cause revision at five years compared to TAA (95% versus 77%; p<0.0001).Patients undergoing THA or TAA experienced significant improvements in their general and joint-specific PROMs post-operatively. However, patients undergoing THA demonstrated higher PROMIS PI and PF scores at one-year when compared to TAA, as well as improved survivorship. Generic PRO instruments enable comparison of medical treatments in different anatomic sites to the patients overall health.

Category:Ankle Arthritis; OtherIntroduction/ Purpose:The orthopaedic field, including foot and ankle surgery, continues to rely onpatient reported outcome measures (PROMs) as the cornerstone of researchstudies. Various questionnaires exist, each with their advantages anddisadvantages. The Patient-Reported Outcomes Measurement Information System(PROMIS) has become increasingly popular due to its reliability, validity,and efficiency. This system has been tested against the Foot and AnkleOutcome Score (FAOS) for foot and ankle conditions, however little is knownabout its validity for patients with ankle arthritis undergoing total anklearthroplasty (TAA). Additionally, its relationship to functional tests isunknown, which could reveal whether it could be used in lieu of theseresource-intensive assessments. Therefore, we aimed to validate PROMISagainst the FAOS and functional tests in TAA patients.Methods:This prospective cohort study included 102 patients (mean age: 63.5 years)who were diagnosed with ankle arthritis and underwent subsequent TAA.Preoperative PROMIS scores, FAOS, and functional tests including the 4square test (4SST), timed up and go (TUG), and sit-to-stand (STS) weregathered and analyzed preoperatively. PROMIS physical function and paininterference domains were tested for reliability using Rasch partial creditmodels. Convergent validity between PROMIS physical function and paininterference, and FAOS function, daily living was evaluated using Spearman’scorrelation coefficient. In addition, the relationship between thefunctional tests and all 6 PROMIS domains were evaluated using Spearman’scorrelation coefficient.Results:Infit and outfit mean squares (MSQs) for PROMIS physical function ranged from0.61 – 0.78, indicating a good fit in the Rasch model. Similarly, infit andoutfit MSQs for PROMIS pain interference ranged from 0.77 – 0.8, alsoindicating a good fit.Separation reliability was 0.89 for physical function and 0.85 for paininterference, indicating good reliability to actual patient function andpain levels. PROMIS physical function demonstrated a moderate positivecorrelation with FAOS function, daily living (r=0.52) while paininterference demonstrated a moderate negative correlation (r=-0.52). PROMISphysical function demonstrated statistically significant weak negativecorrelations for all 3 functional tests (r=-0.19 for 4SST, r=-0.27 for TUG,r=-0.2 for STS) [Figure 1].Conclusion:Our study revealed good reliability of PROMIS physical function and paininterference domains, with a moderate correlation to FAOS function, dailyliving. Additionally, we found weak correlations between PROMIS physicalfunction and functional tests and no significant correlations between paininterference and functional tests. This indicates acceptable convergentvalidity to the FAOS but not to functional tests. Therefore, while PROMISprovides reliable and valid measures, it does not replace the need forfunctional tests, which should be pursued in conjunction to deliver acomplete assessment of TAA patients.

BackgroundA crucial component to improving patient care is better clinician understanding of patients’ health-related quality of life (HRQoL). In orthopaedic surgery, HRQoL assessment instruments such as the NIH developed Patient Reported Outcomes Measurement Information System (PROMIS), provide surgeons with a framework to assess how a treatment or medical condition is affecting each patient’s HRQoL. PROMIS has been demonstrated as a valuable instrument in many diseases; however, the extent to which orthopaedic surgery subspecialties have used and validated PROMIS measures in peer-reviewed research is unclear.MethodsSystematic scoping methodology was used to investigate the characteristics of studies using PROMIS to assess HRQoL measures as orthopaedic surgical outcomes as well as studies validating computerized adaptive test (CAT) PROMIS physical health (PH) domains including: Physical Function (PF), Upper Extremity (UE), Lower Extremity (LE).ResultsA systematic search of PubMed identified 391 publications utilizing PROMIS in orthopaedics; 153 (39%) were PROMIS PH CAT validation publications. One-hundred publications were in Hand and Upper Extremity, 69 in Spine, 44 in Adult Reconstruction, 43 in Foot and Ankle, 43 in Sports, 37 in Trauma, 31 in General orthopaedics, and 24 in Tumor. From 2011 through 2020 there was an upward trend in orthopaedic PROMIS publications each year (range, 1–153) and an increase in studies investigating or utilizing PROMIS PH CAT domains (range, 1–105). Eighty-five percent (n = 130) of orthopaedic surgery PROMIS PH CAT validation publications (n = 153) analyzed PF; 30% (n = 46) analyzed UE; 3% (n = 4) analyzed LE.ConclusionsPROMIS utilization within orthopaedics as a whole has significantly increased within the past decade, particularly within PROMIS CAT domains. The existing literature reviewed in this scoping study demonstrates that PROMIS PH CAT domains (PF, UE, and LE) are reliable, responsive, and interpretable in most contexts of patient care throughout all orthopaedic surgery subspecialties. The expanded use of PROMIS CATs in orthopaedic surgery highlights the potential for improved quality of patient care. While challenges of integrating PROMIS into electronic medical records exist, expanded use of PROMIS CAT measurement instruments throughout orthopaedic surgery should be performed.Plain english summary In orthopaedic surgery, health-related quality of life tools such as the NIH developed Patient Reported Outcomes Measurement Information System (PROMIS), offer patients an opportunity to better understand their medical condition and be involved in their own care. Additionally, PROMIS provides surgeons with a framework to assess how a treatment or medical condition is affecting each patient’s functional status and quality of life. The efficacy of PROMIS has been demonstrated in many diseases; however, its application throughout orthopaedic care has yet to be depicted. This study sought to identify the extent to which all orthopaedic surgery subspecialties have used and validated PROMIS measures in peer-reviewed research in order to identify its potential as an applicable and valuable tool across specialties. We determined that PROMIS utilization has significantly increased within the past decade. The existing literature reviewed in this scoping study demonstrates that the PROMIS computerized adaptive test domains evaluating physical function status are reliable, responsive, and interpretable in most contexts of patient care throughout all orthopaedic surgery subspecialties. Based on these results, this study recommends the expanded and more uniform use of PROMIS computerized adaptive test measurement instruments in the clinical care of orthopaedic patients.

Patients presenting with end-stage ankle osteoarthritis (OA) in the setting of a concomitant extra-articular limb deformity pose a challenging problem that has not yet been described in the literature. We describe a case series of patients treated with external and internal fixation techniques followed by total ankle arthroplasty (TAA) in a staged approach to treat this complex presentation. Eight patients with limb deformity and end-stage ankle OA who underwent staged deformity correction and TAA from 2016 to 2019 at our institution were retrospectively identified. Average age was 58.5 (range, 49-68) years, with an average follow-up of 2.6 (range, 0.8-4.2) years. All patients underwent limb reconstruction with either tibial osteotomy with a circular frame (n=6) or intramedullary nail (n=2). Limb deformities consisted of the following: posttraumatic tibial malunion (2), limb length discrepancy (1), acquired tibial deformity (1), genu varum (2), or genu valgum (2). Radiographic parameters were assessed pre- and postoperatively on 51-inch standing and ankle radiographs: limb length discrepancy (LLD), genu varum/valgum deformity, recurvatum deformity, mechanical axis deviation, medial proximal tibial angle, lateral distal tibial angle, anterior distal tibial angle, and tibiotalar alignment. Pre- and postoperative patient-reported outcomes were assessed using 2 metrics, the Limb Deformity-Scoliosis Research Society (LD-SRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores (Physical Function, Pain Intensity, Pain Interference, Global Physical Function, and Global Mental Function). Following staged limb deformity correction and TAA, all patients achieved correction of LLD and angular deformities of the lower limb, along with restoration of normal alignment of the ankle joint. There was significant mean improvement in all patient-reported LD-SRS and PROMIS domains, except for LD-SRS mental health. LD-SRS function improved from 2.6 (±0.7) to 4.6 (±0.2), P = .008; pain improved from 2.9 (±0.9) to 4.8 (±0.2), P = .012; self-image improved from 2.9 (±0.4) to 4.7 (±0.3), P < .001; and total LD-SRS improved from 3.3 (±0.4) to 4.8 (±0.2), P = .002. Average satisfaction was 4.9 (±0.3). PROMIS physical function improved from 32.3 (±6.8) to 51.3 (±5.3), P = .008; pain interference improved from 66.0 (±9.1) to 41.3 (±6.2), P = .004; pain intensity improved from 60.0 (±13.3) to 33.1 (±5.3), P = .007; global physical health improved from 39.3 (±6.8) to 60.7 (±5.1), P = .002; global mental health improved from 54.8 (±5.9) to 65.6 (±2.8), P = .007. There was one incidence of pin site infection and one reoperation. Deformity correction with either external frame or intramedullary nail fixation followed by TAA in a staged approach was a viable surgical option in the treatment of end-stage ankle OA with concurrent extra-articular limb deformity. This unique approach was capable of achieving deformity correction with improved patient-reported outcomes, minimal complications, and good patient satisfaction. Level IV, retrospective case series.

e23192 Background: Patient-reported outcome measures (PROMs) are critical for patient-centered care in oncology, as they allow patients to communicate with their care team about a range of symptoms using well-validated tools. However, successful use of PROMs in routine care depends on the clinical user experience: the opinions and experiences of the clinicians and staff who administer and make treatment decisions using PROMs. This study characterizes the use of the NIH-sponsored Patient Reported Outcomes Measurement Information System (PROMIS) in routine oncological care through a literature review and user survey. Methods: First, we conducted a narrative review of papers published from 2010 to June 2023 to identify breadth of PROMIS use in routine care. We screened 262 abstracts and identified 10 articles describing routine care in patients with cancer. We coded for institution type, PROM administration methods, and types of PROMIS measures. Next, we conducted a survey to solicit the opinions and experiences of diverse stakeholders implementing PROMIS in routine care. We contacted 209 known users of PROMIS (published authors, PROMIS API clients, and respondent referrals). Item frequencies were used to characterize survey responses. Chi-square tests were used to test differences between users in oncology and other fields. Results: Review. Nine of the 10 institutions using PROMIS in routine cancer care were academic medical centers. Articles reported on data from 2011-2021. The most popular PROMIS measure was PROMIS Global Health which provides summary scores of physical and mental health. Other popular domains included fatigue (4), physical function (3), depression (3), and anxiety (3), all measured by PROMIS computerized adaptive tests (CATs). They were most often administered in the clinic waiting room (7) or online before appointments (6). Most institutions (6) had PROMIS results automatically integrated into the electronic health record. Survey. We had 89 respondents (6 from oncology). PROMIS users in oncology were more likely to have structured training on the use of PROMIS than other users (χ2 (1,79) = 6.0, p = 0.01) and less likely to give patients direct access to their results (χ2 (1,72) = 6.0, p = 0.01). Users in oncology did not differ from the whole sample in opinions of PROMIS (% agree): users viewed PROMIS as worthwhile (86%), clinically relevant (85%), easy to administer (76%), statistically reliable (73%), and beneficial to treatment monitoring (68%), but were less confident that PROMIS improves doctor-patient communication (57%), treatment decision-making (54%), or patient satisfaction (35%). Conclusions: Conclusions PROMIS has been successfully integrated into routine oncological care in several academic medical centers. While adoption is not widespread, these initial results suggest that PROMIS is a useful tool for symptom monitoring in cancer care.

AimsThis study evaluated joint-specific and generic patient-reported outcome measures (PROMs) after total hip arthroplasty (THA) and total ankle arthroplasty (TAA) in matched cohorts, while evaluating implant survivorship and 90-day hospital use.MethodsPrimary THA and TAA patients from 1 January 2015 to 1 January 2023 with minimum one-year follow-up were retrospectively reviewed. After applying exclusion criteria, 2,092 THAs and 478 TAAs were analyzed. Demographics, pre- and postoperative PROMs, revision surgeries, emergency department visits, and readmissions were collected. THA and TAA patients were then propensity score matched at a 2:1 ratio for age, sex, race, BMI, American Society of Anesthesiologists classification, and comorbidities, resulting in a final cohort of 844 THAs and 455 TAAs for comparison.ResultsMedian preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PI) scores between THA and TAA were calculated (66.0 (IQR 62.0 to 70.0) vs 65.0 (IQR 62.0 to 70.0); p = 0.276), and both showed improvement at six weeks. However, THA patients exhibited lower median PROMIS PI scores at one year (53.0 vs 54.0; p = 0.009), as well as a greater median decrease in PROMIS PI from preoperative to one year (-13.0 (IQR -20.0 to -8.0) vs -12.0 (IQR -18.0 to -7.0); p = 0.023). Median preoperative PROMIS physical function (PF) was worse in THA patients (36.0 (IQR 32.0 to 40.0) vs 37.0 (IQR 33.0 to 40.0); p = 0.031), but showed greater median improvement compared to TAA patients at both six weeks (7.0 (IQR 3.0 to 12.0) vs 3.0 (IQR -2.0 to 9.0); p < 0.001) and one year (11.0 (IQR 6.0 to 17.0) vs 8.0 (IQR 4.5 to 13.0); p < 0.001). Preoperative PROMIS depression scores were similar and improved similarly in both groups. Joint-specific PROMs improved in both cohorts.ConclusionPatients undergoing THA or TAA experienced improvements in joint-specific PROMs postoperatively which translated to improved generic PROMs across both joints. Generic PROMs can be a useful tool to compare outcomes in THA and TAA. Results suggest that higher functional scores may be achieved sooner in THA.Cite this article: Bone Jt Open 2025;6(5 Supple A):1–13.

Joint replacement procedures have traditionally been performed in an inpatient setting to minimize complication rates. There is growing evidence that total ankle arthroplasty (TAA) can safely be performed as an outpatient procedure, with the potential benefits of decreased health care expenses and improved patient satisfaction. Prior studies have not reliably made a distinction between outpatient TAA defined as length of stay <1 day and same-day discharge. The purpose of our study was to compare a large volume of same-day discharge and inpatient TAA for safety and efficacy. Patients undergoing TAA at our US-based institution are part of an institutional review board-approved registry. We queried the registry for TAA performed by the single highest-volume surgeon at our institution between May 2020 and March 2022. Same-day discharge TAA was defined as discharge on the day of the procedure. Patient demographics, baseline clinical variables, concomitant procedures, postoperative complications, and patient-reported outcomes were collected. Postoperative outcomes were compared after 1:1 nearest-neighbor matching by age, sex, Charlson Comorbidity Index (CCI), and American Society of Anesthesiologists (ASA) score. Multivariable models were created for comparison with the matched cohort outcome comparison analysis. Our same-day discharge group was younger (median 58 vs 67 years; P < .001), with proportionally fewer females (36.4% vs 51.4%; P = .044) and lower Charlson Comorbidity Indices (median 1 vs 3; P < .001) than the inpatient group. At a median follow-up of 1 year, after matching by age, sex, CCI, and ASA score, there was no difference in complications (P = .788), reoperations (P = .999), revisions (P = .118), or Patient-Reported Outcomes Measurement Information System (PROMIS) scores between the 2 groups. Multivariable analyses performed demonstrated no evidence of association between undergoing same-day discharge TAA vs inpatient TAA and reoperation, revision, complication, or 1-year PROMIS scores (P > .05). In our system of health care, with appropriate patient selection, same-day discharge following TAA can be a safe alternative to inpatient TAA. Level III, retrospective cohort study.

The Cadence Total Ankle System is a 2-component, fixed-bearing fourth-generation total ankle arthroplasty (TAA) system that was introduced for clinical use in 2016. The purpose of this study was to report non-inventor, non-industry funded survivorship, radiographic and clinical outcomes, and early complications following use of this implant at a minimum of 2 years. This single-center retrospective study included patients who underwent TAA by 2 surgeons with this novel fixed-bearing system between January 2017 and September 2018. Forty-eight patients were evaluated at an average of 33.6 months. Radiographic outcomes included preoperative and postoperative tibiotalar angle on anteroposterior radiographs of the ankle, sagittal tibial angle (STA) on lateral radiographs of the ankle, and periprosthetic lucency formation and location. Revision and reoperation data were collected, and patient-reported outcomes were assessed using Patient Reported Outcomes Measurement Information System (PROMIS). Subgroup analysis assessed associations between preoperative deformity, postoperative implant alignment, PROMIS scores, and periprosthetic lucency formation. Survivorship of implant was 93.7%, with 3 revisions, 1 due to infection and 2 due to loosening of the implant (1 tibial and 1 talar component). Three patients had reoperations (6.3%): 2 for superficial infection and 1 for gutter debridement due to medial gutter impingement. Fifteen patients (35.8%) developed periprosthetic lucencies, all on the tibial side. PROMIS scores improved after surgery in all domains except Depression. Patients with significant postoperative periprosthetic lucency had worse postoperative PROMIS Physical function scores than patients without lucency (P < .05). This study demonstrated excellent minimum 2-year clinical and radiographic outcomes and low revision and reoperation rates of this new fourth-generation TAA system. Future studies with longer follow-up, especially on patients with periprosthetic lucency, are necessary to investigate the long-term complications and understand the long-term functional and radiographic outcomes of this implant.

Category:Ankle Arthritis; Ankle; OtherIntroduction/Purpose:The Cadence Total Ankle System (Smith and Nephew, Memphis, TN) is a two-component, fixed-bearing fourth generation total ankle arthroplasty (TAA) system that was introduced for clinical use in 2016. Few studies have investigated short-term outcomes of this new TAA system, and no outcomes have yet been reported by independent authors. The purpose of this study was to report non-inventor, non-industry funded survivorship, radiographic and clinical outcomes, and early complications following use of the new fourth generation TAA system at a minimum of 2 years.Methods:This is a single-center retrospective study of patients who underwent TAA by two surgeons with the Cadence between January 2017 and September 2018. There were 50 ankles in 50 patients, and 48 (96%; mean age of 66.1 years) patients were evaluated at a minimum 2-year follow-up. Two patients were lost due to death and refusal to participate in the study. Patients had an average follow-up of 33.6 (range, 24-50) months. Radiographic outcomes included preoperative and postoperative tibiotalar alignment (TTA) on anteroposterior radiographs of the ankle, sagittal tibial alignment (STA) on lateral radiographs of the ankle, and periprosthetic cyst formation (greater than 5mm in size) and cyst location. Data regarding reoperations and revisions were also collected. Patient-reported outcomes were assessed using Patient Reported Outcomes Measurement Information System (PROMIS). Subgroup analysis was performed to assess for associations between preoperative deformity, postoperative implant alignment, PROMIS scores, and periprosthetic cyst formation.Results:Survivorship of implant was 93.7%, with 3 revisions, 1 due to infection and 2 due to loosening of the implant (one tibial and one talar component). Three patients had reoperations (6.3%): 2 for irrigation and debridement for cellulitis, and 1 for gutter debridement due to medial gutter impingement. Preoperatively, 9 ankles had varus alignment (mean TTA 77.9 degrees), 20 had neutral alignment (mean TTA 90.2 degrees), and 13 had valgus alignment (mean TTA 102.9 degrees). Postoperatively, TTA and STA significantly improved, and all patients demonstrated neutral coronal alignment (TTA between 85 and 95 degrees). Fifteen patients (35.8%) developed periprosthetic cysts, all on the tibial side. PROMIS scores improved after surgery in all domains except Depression (Table 1). Patients with postoperative periprosthetic cysts had a smaller preoperative STA and a worse postoperative PROMIS Physical function and Pain interference domain than patients without periprosthetic cysts (p<0.05).Conclusion:This study demonstrated excellent minimum 2-year clinical and radiographic outcomes, along with low revision and reoperation rates, of this new fourth generation TAA system. Future studies with longer follow-up, especially on patients with periprosthetic cysts, are necessary to investigate the long-term complications and understand the long-term functional and radiographic outcomes of this implant.

Background: Functional status is a critically important outcome measure after stroke. The ability to electronically capture this through self-report is increasing. The Patient Reported Outcomes Measurement Information System (PROMIS) uses computer adaptive testing (CAT), which can increase score precision and reduce patient burden. The number of questions depends on the patient’s responses. The objective of this study was to evaluate the performance of the PROMIS physical function scale (PROMIS PF) compared to the validated Stroke Impact Scale 16 (SIS16) in an ambulatory stroke clinic. Methods: Patient-reported PROMIS PF (CAT version) and SIS16 were electronically collected on patients seen in the stroke clinic using the Knowledge Program platform. Patient completion rates were &gt; 70%. Distribution of scores was compared to assess ceiling/floor effects. Internal consistency was assessed by calculating the SEM for PROMIS PF and Cronbach’s alpha for SIS16. Correlations with NIHSS were performed to assess convergent validity. Results: The PROMIS PF and SIS16 were collected on 5,691 patients from Jan 2010 - May 2014. Mean SIS16 score = 81.4 (SD 21.5), mean PROMIS PF score = 42.8 (SD 11.2). The SIS16 had a22% ceiling effect, &lt;1 % ceiling effect was seen with PROMIS PF (Figure). Patients completed 16 SIS16 items and a median of 4 [IQR 4, 5] PROMIS PF items. Cronbach’s alpha for SIS16 = 0.959, SEM for PROMIS PF = 2.3; both values suggest excellent internal consistency. Test-retest correlation was 0.867 for SIS16 and 0.87 for PROMIS PF. Correlations between NIHS and the 2 scales were -0.461 (p&lt;0.001) for PROMIS PF and -0.559 (p&lt;0.0001) for SIS16. Conclusion: The use of the PROMIS system to obtain electronic patient-reported functional status in ambulatory stroke clinic is feasible. PROMIS PF is an option for measurement of physical function in patients with stroke. It had similar test characteristics as the SIS16 but with lower patient burden and no ceiling effect.

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.

Are PROMIS and Legacy Patient-Reported Outcome Measures Correlated for Patients Undergoing Carpal Tunnel Release?