Reported Outcomes Measurement Information System Research Articles

Quality of Life and Bladder Symptoms in Adolescents and Young Adults With Spina Bifida Who Catheterize via Urethra Versus Catheterizable Channel.

To assess associations between health-related quality of life (HRQOL), bladder-related QOL, bladder symptoms, and bladder catheterization route among adolescents and young adults (AYA) with spina bifida (SB). Clinical questionnaires administered to individuals ≥ 12-years-old requiring catheterization between June 2019-March 2020 in a SB center were retrospectively analyzed. Questionnaires were completed in English or Spanish independently or with caregiver assistance. Medical records were reviewed for demographic and clinical characteristics. Primary exposure was catheterization route (urethra or channel). Primary outcome was HRQOL, measured by Patient Reported Outcome Measure Information System Pediatric Global Health 7 (PGH-7). Secondary outcomes were bladder-related QOL and bladder symptoms, measured by Neurogenic Bladder Symptom Score (NBSS). Nested, multivariable linear regression models assessed associations between catheterization route and questionnaire scores. Of 162 patients requiring catheterization, 146 completed both the PGH-7 and NBSS and were included. Seventy-three percent catheterized via urethra and 27% via channel. Median age was 17.5 years (range 12-31), 58% of patients were female, and 80% had myelomeningocele. Urinary incontinence was more common among those who catheterized via urethra (60%) compared to channel (33%). On adjusted analyses, catheterization route was not significantly associated with PGH-7 or NBSS bladder-related QOL scores. More bladder symptoms were associated with worse bladder-related QOL. Patients who catheterized via channel had fewer bladder symptoms than those who catheterized via urethra. Catheterization route was not significantly associated with QOL. Though catheterization via channel was associated with fewer bladder symptoms, only degree of current bladder symptoms was significantly associated with bladder-related QOL.

Concurrent Validity of PROMIS and LD-SRS Scores in Pediatric Patients With Lower Limb Differences.

We sought to assess the concurrent validity of select Patient Reported Outcomes Measurement Information System (PROMIS) domains and Limb Deformity-Scoliosis Research Society (LD-SRS) scores. We prospectively administered PROMIS-25 (including anxiety, depression, fatigue, pain interference, peer relationships, and physical function) and LD-SRS questionnaires to 46 consecutive pediatric patients with lower limb differences, presenting to a single surgeon for reconstruction. Concurrent validity between various subdomains of the 2 outcome measures was assessed through Pearson's correlation, with significance defined as P <0.05. The strength of correlation was interpreted by Evans criteria: absolute r value <0.20 indicating very weak correlation; 0.20 to 0.39, weak; 0.40 to 0.59, moderate; 0.60 to 0.79, strong; and 0.8 or greater indicating very strong correlation. The LD-SRS Pain, Function, and Mental Health domains most strongly correlated with the PROMIS pain interference (r=-0.79, P<0.001), physical function (r=0.74, P<0.001), and anxiety (r=-0.68, P <0.001) domains, respectively. In addition, LD-SRS pain strongly correlated with PROMIS physical function (r=0.61, P<0.001) and LD-SRS function with PROMIS pain interference (r=-0.72, P<0.001). All PROMIS domains significantly correlated with total LD-SRS scores. PROMIS pain interference (r=-0.79, P <0.001), physical function (r=0.67, P <0.001), and fatigue (r=-0.60, P <0.001) domains demonstrated the strongest correlations with the total LD-SRS score. The significant concurrent validity between LD-SRS and multiple PROMIS domains suggests considerable overlap, and perhaps redundancy, between these 2 outcome measures. Given the high degree of concordance and the advantage of computer adaptive testing (CAT) in mitigating administrative burden and survey fatigue, along with the ability to compare outcomes across a wider group of children with a variety of underlying diagnoses, select PROMIS domains may be a viable alternative to LD-SRS score for assessing patient-reported outcomes when treating pediatric patients with lower limb deformities. A larger, multi-center study including pediatric patients with lower limb differences from a diverse background, including age, etiology, native language, and ethnicity, would be helpful to externally validate our findings. Level-I.

Peer-Led Symptom Management Intervention to Enhance Resilience in People with Systemic Sclerosis: Mediation Analysis from a Randomized Clinical Trial.

Facilitated self-management interventions have the potential to enhance resilience and well-being. We examined whether resilience is a mediator of improving physical and psychological symptoms for people with systemic sclerosis (SSc) who participated in a 12-week online peer-led symptom management intervention. We conducted a secondary data analysis from a randomized control trial comparing a peer health coached intervention to a waitlist control. Participants completed the Connor-Davidson Resilience Scale, the Functional Assessment of Chronic Illness Therapy-Fatigue scale, and the Patient Reported Outcomes Measurement Information System measures of pain interference and depressive symptoms at the baseline and at weeks 6 and 12. Linear mixed effect regression models were used to assess the effect of intervention on changes in resilience. Causal mediation analyses were conducted to examine whether changes in resilience at week 12 mediated intervention effects on changes in fatigue, pain interference, and depressive symptoms at week 12. One hundred and seventy-three eligible participants were enrolled. Participants in the intervention group reported improvements in resilience (p < .001). These changes in resilience mediated the intervention effects on fatigue with indirect effect of -1.41 (95% Confidence Interval [CI], -2.41 to -0.41), pain interference of -0.86 (95% CI, -1.65 to -0.08), and depressive symptoms of -1.99 (95% CI, -3.16 to -0.81). For participants in the intervention who had positive improvements in their physical and psychological symptoms, increased resilience was a mechanism for these improvements. These findings support the importance of addressing resilience to improve symptoms in similar SSc interventions.

A Comparison of PROMIS Scores in Patients Treated with First Metatarsophalangeal Joint Arthrodesis and Polyvinyl Alcohol Hydrogel Implant Hemiarthroplasty for Hallux Rigidus

Introduction/Purpose: Current literature shows similar clinical outcomes between first metatarsophalangeal joint arthrodesis and polyvinyl alcohol hydrogel (synthetic cartilage implant or SCI) hemiarthroplasty in the treatment of hallux rigidus; however, prior studies have not reported validated patient-reported outcome measures. To our knowledge, this is the first study to compare patient-reported outcome measures using the validated Patient Reported Outcomes Measurement Information System (PROMIS) in patients treated for hallux rigidus with metatarsophalangeal joint arthrodesis and SCI hemiarthroplasty. In addition, this novel study provides comparative data of the complication and revision rates for each procedure. Methods: A retrospective review of prospectively collected data within an institutional registry identified 101 patients who underwent metatarsophalangeal joint arthrodesis and 82 patients who underwent SCI hemiarthroplasty for treatment of hallux rigidus between January 2016 and June 2022. Chart review was performed to obtain demographic information, complications, and revision rates. Preoperative, 1-year, and 2-year PROMIS scores were obtained from the registry and confirmed via chart review. Equivalence testing was performed using two one sided t-tests (TOST) and setting a +/-5 unit margin of difference as the clinically meaningful difference to determine if there was a difference in PROMIS scores between groups. Linear regression models were also utilized to compare adjusted postoperative PROMIS scores between the two cohorts. For the equivalence testing, a p-value &gt; 0.05 indicated a statistically significant result. Results: Demographic information and preoperative hallux rigidus severity between the cohorts showed no statistically significant difference (Table 1). The SCI cohort had no intra-operative or post-operative wound complications, but one patient within the MTP fusion cohort was treated for a superficial wound infection. The SCI group had six patients revised to MTP fusions within 3- years due to continued pain and/or implant subsidence. The MTP fusion group had 2 patients revised due to non-union and 13 patients that had symptomatic hardware requiring removal. Equivalence comparison of PROMIS scores showed the SCI cohort had significantly worse pain intensity scores at 2 years and significantly less improvement in pain intensity scores from pre- operative to 1-year post-op (Table 2). There were no differences found between cohorts for other PROMIS domains. Conclusion: For the treatment of hallux rigidus, the SCI hemiarthroplasty and metatarsophalangeal joint arthrodesis have equivalent outcomes for all PROMIS domains except the pain intensity domain. While patients in both cohorts had improvement in pain from pre-operative to post-operative time points, SCI was not as effective as first MTP fusion at relieving pain intensity at a follow-up of 2 years. While SCI is a motion-sparing procedure, patients with a primary goal of improving pain may be better suited for first MTP joint arthrodesis. Tables demonstrating the comparisons of both the preoperative demographic data as well as demonstrating the PROMIS scores across different time periods (preoperative, 1 year and 2 years).

Single-Center, Early Experience with the First 3D-Printed Surface, Fixed Bearing, Total Ankle Arthroplasty: A Minimum of 2-Year Follow-Up

Introduction/Purpose: As the fourth generation of total ankle arthroplasty (TAA) implants evolve, treatment solutions for end- stage ankle arthritis continue to improve. Technological advancements in CT guided planning and 3-D printing offers surgeons the ability to perform TAA with patient specific instrumentation and implants. 3-D printed components are designed to act as scaffold in hopes to facilitate early in-growth, to increase implant stability, to support long-term survivorship, and ultimately to improve the quality of life our patients. We present our early experience at a single academic center with a minimum of 2-year follow up data on the first 3-D printed, fixed bearing, TAA in the United States. We hypothesize that 3-D printed technology will demonstrate improved long-term survival and increased bony in-growth on the implant-bone interface. Methods: A retrospective review was performed on patients who underwent TAA with a minimum of 2-year clinical and radiographic data in which this 3-D printed TAA was utilized at our single academic center. Patient demographic, radiographic, and functional outcome scores were collected preoperatively, at 6 months, 1 year, and 2 years. The severity of ankle arthritis and associated deformities in patients were stratified using the COFAS classification. The primary outcomes of this study were implant survivorship, comparative analysis of preoperative and postoperative Patient Reported Outcomes Measurement Information System (PROMIS) physical function scores, VAS pain scores, radiographic development of linear radiolucency &gt;2 mm, cystic radiolucency &gt; 5mm, subsidence, and adverse events within 2 years of surgery. Results: Thirty patients were included with a median follow-up of 26 months (range, 24-36 months). Implant survival rate was 90%. One patient was revised to a stemmed TAA secondary to tibial subsidence. One patient required a TTC fusion secondary to Charcot collapse. One patient was revised to a staged ankle fusion secondary to periprosthetic joint infection. Two patients (6.7%) experienced linear radiolucency &gt;2mm with tibial subsidence in which one patient required a revision TAA (mentioned above) and another who was asymptomatic. No significant cystic radiolucency &gt;5 mm were identified. Five patients required re-operation from complications unrelated to the implant. VAS scores decreased significantly from 6 (IQR, 4-8) to 1 (IQR, 2-4) (P &lt;.001; r=0.55). PROMIS Physical scores increased significantly from 43.6 (IQR, 33-47.7) to 50.8 (44.8-57.7)(P &lt;.001; r=0.60). Conclusion: The utilization of this new 3-D printed, fixed bearing TAA demonstrated a ninety percent overall implant survival rate in our small cohort of patients. Further data will be required to determine the long term efficacy of this new 3-D printed implant on patient outcomes. Our early experience and complications presented in our study demonstrate that this 3-D printed TAA implant is safe and effective in the treatment of end-stage ankle arthritis.

Self-Reported Well-Being of Family Caregivers of Children with Medical Complexity

ObjectivesProvide an in-depth and psychometrically rigorous profile of the emotional well-being and sleep-related health of family caregivers of children with medical complexity (CMC). MethodsCross-sectional survey study of family caregivers of CMC receiving care from a pediatric complex care center between May 2021 and March 2022. Patient Reported Outcomes Measurement Information System Short-Forms (PROMIS-SF) assessed global mental health, emotional distress (anxiety, depression, anger), psychological strengths (self-efficacy, emotional regulation, meaning and purpose), and sleep-related health (fatigue, sleep-related impairment). Student’s t-tests compared the sample’s mean T-scores to US population norms. Pearson’s correlation coefficient (ρ) examined associations between measures of psychological strengths and emotional distress. Unadjusted linear regression analyses explored relationships between well-being outcomes and child and caregiver characteristics. ResultsCompared to US population norms, caregivers of CMC (n = 143) reported significantly lower global mental health and emotional regulation ability as well as elevated symptoms of anxiety, depression, anger, fatigue, and sleep-related impairment (all p <.001). Whereas participants reported a significantly higher sense of meaning and purpose (p<.05), levels of self-efficacy were not significantly different from population norms. We observed moderate-to-strong inverse relationships between psychological strengths and emotional distress (ρ range, -0.39 to -0.69); with the strongest inverse associations found between emotional regulation ability and emotional distress. In exploratory analyses, caregiver race/ethnicity, socioeconomic status, and child health insurance type were significantly associated with caregiver well-being. ConclusionFamily caregivers of CMC report poor well-being, most notably, increased symptoms of anxiety and reduced global mental health and sleep-related health. What’s NewIn this cross-sectional survey of family caregivers of children with medical complexity, caregivers reported clinically significantly poorer global mental health, higher emotional distress, and reduced sleep-related health. This study provides potential therapeutic targets for future psychosocial interventions.

492 Pain and falls among persons with multiple sclerosis.

OBJECTIVES/GOALS: Falls are very common among persons with multiple sclerosis (PwMS) due to the disabling symptoms associated with the disease. The relationship between pain and falls is underexplored. This study investigated the relationship between the facets of pain (intensity and interference) and falls in the context of co-occurring symptoms of MS. METHODS/STUDY POPULATION: This is a survey-based study that included 915 adults with MS. Participants provided data on demographics, clinical data, concerns about falling, symptom severity, and occurrence of falls in the past 6 months. Participants also completed the Patient Reported Outcome Measurement Information System (PROMIS) pain interference and pain intensity short forms. Pain interference and pain intensity were separately entered into univariate and multivariable logistic regression models developed to examine the associations between falls incidence and pain. Multivariable models were adjusted for age, sex, years since diagnosis, MS type, Patient Determined Disease Steps, MS status, concerns about falling, fatigue severity, PROMIS depression short form, and PROMIS physical function short form. RESULTS/ANTICIPATED RESULTS: Univariate regression analyses indicated that pain interference (OR = 1.05; 95% CI 1.03 to 1.06; p &lt; 0.01) and pain intensity (OR = 1.03; 95% CI 1.02 to 1.04; p &lt; 0.01) were both associated with falls. Only pain interference remained significantly associated with falls in multivariable regression analysis (OR = 1.02; 95% CI 1.00 to 1.05; p = 0.03). The model explained 25% of the variance in falls. Pain intensity was not associated with falls (OR = 0.98; 95% CI 0.95 to 1.01; p &gt; 0.05) in multivariable regression analysis. DISCUSSION/SIGNIFICANCE: The findings suggest that pain is associated with falls among PwMS. Interventions designed to reduce falls incidence among PwMS may consider the inclusion of pain management as an integral component of those programs.

A study to identify the quality of life among post COVID-19 people

The COVID-19 pandemic, caused by the SARS-COV-2 virus, has not only led to significant morbidity and mortality worldwide but has also profoundly impacted the quality of life of people post-recovery. This study aims to analyze the quality of life among post-COVID-19 people in Kolhapur, India, and to explore associations between their quality of life with their selected socio-demographic variables. A qualitative approach was considered. A non-experimental, exploratory research design was adopted, with data collected from 225 people through convenient sampling technique. Structured interview questionnaires and the Patient Reported Outcome Measurement Information System (PROMIS) scale were utilized. The majority of subjects reported good quality of life (69.33%), with a smaller proportion reporting average quality (30.22%), and only one subject (0.44%) indicating poor quality of life. Statistical analysis revealed a significant association between quality of life and type of diet and treatment, while no significant associations were found with other demographic variables. This study underscores the importance of addressing the psychological and physical well-being of post-COVID-19 people and suggests the need for tailored rehabilitation programs to improve their quality of life.

[Comparison of pain intensity measurements among patients with low-back pain].

<p>Pain intensity is the most frequently assessed health domain in clinical studies among patients with low-back pain. Visual analogue scale (VAS) and Numeric rating scale (NRS) have been the mostly used measurement tools for pain intensity. We proposed to correlate these instruments to a generic health-related quality of life measurement tool in order to show the scale with superior clinical relevance.</p>. <p>We used cross-sectional, convenience sampling. 120 patients with chronic low-back pain administered the 29-item Patient Reported Outcomes Measurement Information System Profile with NRS included, and the VAS scale in the National Institute of Mental Health, Neurology and Neurosurgery. We determined the correlation between PROMIS domain T-scores and VAS and NRS scores.</p>. <p>We performed Spearman rank correlation test to calculate the correlation coefficient. We found VAS scales measuring pain had weak to moderate correlations with all PROMIS health domains (r = 0.24&ndash;0.55). Therefore, we compared correlation of PROMIS domain scores with PROMIS pain intensity numeric rating scale and VAS scales. PROMIS domains had moderate to strong correlations with pain intensity scale (r = 0.45&ndash;0.71). PROMIS physical function short form [r = &ndash;0.65, 95% CI (&ndash;0.75) &ndash; (&ndash;0.55)] and PROMIS pain interference short form (r = 0.71, 95% CI 0.63 &ndash; 0.79) had the strongest correlation with pain intensity item.</p>. <p>NRS has showed greater correlation with PROMIS domain T-scores than VAS scale. This may prove that NRS has greater connection to another health domains, thus it correlated more to health-related quality of life than visual scale. We recommend NRS to use in further clinical studies conducted among patients with low-back pain.</p>.

Implementation and Evaluation of a National Well-Being Curriculum for KL2 Scholars.

Introduction: The study aimed to pilot test a well-being curriculum for KL2 scholars to be used across the Clinical and Translational Science Award consortium. Methods: Between November 2022, and May 2023, 36 KL2 scholars from 25 hubs participated in the program. The General Well-Being Index for U.S. Workers and the Patient Reported Outcomes Measurement Information System (PROMIS-29) were completed by scholars before and after the program. Results: Postparticipation, there was a trend of improvement in the domains of well-being, sleep, anxiety, and fatigue. Conclusion: Implementing a virtual synchronous well-being curriculum allowed the scholars to connect across the consortium and improve their well-being.

Utility of PROMIS Measures in Predicting Shoulder Arthroplasty in Patients with Shoulder Osteoarthritis

The decision to treat shoulder osteoarthritis definitively with shoulder arthroplasty (SA) is multifactorial, considering objective findings, subjective information, and patient goals. The first goal of this study was to determine if Patient Reported Outcome Measurement Information System (PROMIS) measures correlated with patients with shoulder osteoarthritis (OA) who underwent SA within 1 year. The second goal of this study was to determine if score cut-offs in PROMIS domains could further discriminate which shoulder OA patients underwent SA within 1 year. This retrospective case-control study examined patients with a diagnosis of shoulder OA who consulted an orthopedic provider from November 1, 2020, to May 23, 2022, and recorded PROMIS measures in the domains of Physical Function (PF), Depression, and/or Pain Interference (PI). A surgical group was defined as patients who underwent SA within 1 year of the most recent PROMIS measures, and the non-surgical patients were defined as the control group. Mean PROMIS scores were compared between the surgical and control groups. Separate logistic regression models controlling for age, race, ethnicity, and comorbidity count were performed for each PROMIS domain as a 1) continuous variable, then as 2) binary variable defined by PROMIS score cut-off points to determine which scores correlated with undergoing SA to further characterize the potential clinical utility of PROMIS score cut-offs in relating to undergoing SA. The surgical group of 478 patients was older (68.2 vs. 63.8 years), more often of White race (82.6% vs. 70.9%), and less often of Hispanic Ethnicity (1.5% vs. 2.9%) than the control group of 3343 patients. Using optimal cut-offs in PROMIS scores, PI ≥ 63 (Odds Ratio (OR) = 2.97 (2.41-3.64), p < 0.001), PF ≤ 39 (OR = 1.81 (95% CI, 1.48-2.22), p < 0.001), and Depression ≥ 49 (OR = 1.82 (95% CI, 1.50-2.22), p < 0.001) were all found to correlate with undergoing SA within 1 year in multivariable logistic regressions. The results of this study demonstrate that cut-off scores for PROMIS measures differentiated patients undergoing SA within 1 year. These cut-off scores may have clinical utility in aiding in decision-making regarding surgical candidates for SA. Further research is needed to validate these cut-off scores and determine how they relate to patient outcomes after SA.

Long-Term Outcomes of Pediatric Traumatic Brain Injury Following Inpatient Rehabilitation.

Assess residual disability in youth with traumatic brain injury (TBI) treated in a pediatric inpatient rehabilitation unit and examine associations of disability with inpatient status and measures of concurrent functioning. Large, urban, quaternary care children's hospital in the Midwestern United States. Forty-five youth aged 6 to 18 years treated in an inpatient rehabilitation unit for mild-complicated to severe TBI at a minimum of 12 months postdischarge (mean = 3.5 years). Retrospective chart review of clinical data collected from standard clinical care at admission and discharge combined with follow-up data examining current functioning at the time of study enrollment. Glasgow Outcome Scale-Extended, Pediatric Revision (GOS-E Peds), Neurology Quality of Life Measurement System Short Form (NeuroQOL) Social Interaction with Peers and Cognitive Short Forms, Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Strengths and Difficulties Questionnaire, and the Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2). Based on parent report at follow-up, 62% of the children had residual TBI-related disabilities on the GOS-E Peds, while 38% reported "good recovery." Children with residual disability also reported more long-term problems in overall health, social relationships, emotional regulation, behaviors, and executive functioning than those with no residual disability. Measures of functional independence and cognitive recovery at discharge were associated with these impairments. More than half of the children with TBI in this study had residual disability more than 1 year after inpatient rehabilitation. Findings highlight the associations between measures of functional independence and cognitive recovery during inpatient rehabilitation with later outcomes and underscore the need for continued services to support the needs of children with TBI following their inpatient rehabilitation stay.

Early results of combined total ankle total talus replacement in the revision setting

BackgroundRevision of failed total ankle replacement (TAR) is challenging and associated with increased morbidity. Given the increased popularity of TAR in treating end-stage ankle arthritis (ESAA), viable revision options are needed. The objective of this case series is to present a minimum 2-year clinical and radiographic outcomes of patient-specific custom 3D-printed total ankle total talus (TATR) prostheses in this unique subset of patients. Methods19 participants with ESAA and failed primary TAR who underwent TATR by a single surgeon at our institution from 2019 to 2021 were retrospectively identified. All participants were indicated for revision of primary STAR implant (Stryker, Kalamazoo, MI) and underwent replacement with 3D-printed titanium implants based on preoperative CT analysis (Additive Orthopaedics, Little Silver, NJ). Custom components included a mobile-bearing total talus and stemmed tibial system, performed through an anterior approach. Pre- and postoperative patient-reported outcomes were assessed using the Patient Reported Outcomes Measurement Information System (PROMIS). Pre- and postoperative implant alignment was assessed using medial distal tibial angle (MDTA) and tibiotalar angle (TTA) on anteroposterior, and sagittal tibial angle (STA) on lateral weight-bearing plain films. ResultsThe average patient age was 60.6 (range, 39–77) years, with an average follow-up of 37.9 (range, 25.3–57.5) months. There was statistically significant improvement in all PROMIS domains. Short-term survivorship was 100%, with two participants (11.0%) requiring reoperation for postoperative complications: one underwent open reduction internal fixation of the tibia for a periprosthetic fracture, and another underwent medial gutter debridement and tarsal tunnel release for recurrent pain. There were no significant differences in pre- versus postoperative radiographic alignment measured by MDTA (89.9 vs 86.4), TTA (89.7 vs 88.1), or STA (85.2 vs 85.3). ConclusionCustom 3D-printed TATR is a promising option for revision TAR. There was significant short-term improvement in pain and physical function, with excellent short-term survivorship and an acceptable postoperative complication rate.

Development of the American College of Rheumatology Patient-Reported Outcome Quality Measures for Systemic Lupus Erythematosus.

As part of a Centers for Disease Control and Prevention-funded American College of Rheumatology (ACR) initiative, we sought to develop quality measures related to Patient Reported Outcome Measure (PROM) use for systemic lupus erythematosus (SLE) clinical care. An expert workgroup composed of physician, patient, and researcher representatives convened to identify patient-reported outcome (PRO) domains of greatest importance to people with SLE. A patient advisory panel separately ranked domains. PROMs assessing priority domains were identified through structured literature review, and detailed psychometric reviews were conducted for each PROM. In a Delphi process, the expert workgroup rated PROMs on content validity, psychometric quality, feasibility of implementation, and importance for guiding patient self-management. The patient advisory panel reviewed PROMs in parallel and contributed to the final recommendations. Among relevant PRO domains, the workgroup and patient partners ranked depression, physical function, pain, cognition, and fatigue as high-priority domains. The workgroup recommended at least once yearly measurement for (1) assessment of depression using the Patient Health Questionnaire or Patient Reported Outcomes Measurement Information System (PROMIS) depression scales; (2) assessment of physical function using PROMIS physical function scales or the Multi-Dimensional Health Assessment Questionnaire; and (3) optional assessments of fatigue and cognition. Pain scales evaluated were not found to be sufficiently superior to what is already assessed in most SLE clinic visits. Expert workgroup members and patient partners recommend that clinicians assess depression and physical function at least once yearly in all people with SLE. Additional PROMs addressing cognition and fatigue can also be assessed. Next steps are to incorporate PROM-based quality measures into the ACR The Rheumatology Informatics System for Effectiveness registry.

Using PROMIS Scores to Provide Cost-Conscious Follow-up After Foot and Ankle Surgery.

National campaigns in the United States, such as Choosing Wisely, emphasize that decreasing low-value office visits maximizes health care value. Although patient-reported outcomes (PROs) are frequently used to quantify postoperative outcomes, they have not been assessed as a tool to help guide clinicians consider alternatives or discontinue in-person follow-up visits. The purpose of this study is to assess the frequency and cost of in-person follow-up visits after patients report substantial improvement defined as 2 consecutive improvements above preoperative Patient Reported Outcomes Measurement Information System (PROMIS) pain interference (PI) scores. Retrospective PROMIS PI data were obtained between 2015 and 2020 for common elective foot (n = 759) and ankle (n = 578) surgical procedures. Patients were divided into quartiles according to their preoperative PI score. Multivariable Cox proportional hazards models were used to investigate time to substantial improvement. Substantial improvement was defined as having 2 consecutive postoperative minimal clinically important differences (MCIDs) above preoperative PROMIS PI scores. MCID was measured using the distribution-based method. Multivariable negative binomial models were used to determine the number of visits and direct associated costs after substantial improvement. The cost to payors was estimated using reimbursement rates. Within 3 months, 12% to 46% of foot and 16% to 61% of ankle patients achieved substantial improvement. Results vary by preoperative pain quartile, with patients who report higher preoperative pain scores achieving earlier improvement. After achieving substantial improvement, foot and ankle patients averaged 3.60 and 4.01 follow-up visits during the remaining 9 months of the year. Visit costs averaged $266 and $322 per foot and ankle patient respectively. Postoperative follow-up visits are time-consuming and costly. Physicians might consider objective measures, such as PROMIS PI, to determine the need, timing, and alternatives for in-person follow-up visits for elective foot and ankle surgeries after patients demonstrate reliable clinical improvement. Level III, retrospective cohort study at a single institution.

Impact of psychosocial factors on the success of neuromodulation treatment for patients with persistent pain

IntroductionSignificant interindividual variability in spinal cord stimulation (SCS) outcomes exists. Due to its high cost and risks of complications, criteria to guide patient selection for SCS trials and their outcomes...

Validation of the Oswestry Disability Index in Adult Spinal Deformity.

Retrospective cohort. To examine the validity of the ODI in ASD patients treated with surgery. The ODI is a patient-reported outcome measure (PROM) of low back pain and disability. While nearly ubiquitous in adult spinal deformity (ASD) research, the measure has not been validated in this patient population. A registry of ASD patients was queried for baseline and 1-year PROM data, including the ODI, the SRS-22r, and the Patient Reported Outcomes Measurement Information System - Pain Interference (PI), and -Physical Function(PF) computer adaptive tests (CAT). Internal reliability was assessed with Cronbach's alpha, where values≥0.7 are considered reliable. Validity was assessed with Spearman correlation coefficients calculated for the ODI against validated PROMIS-Pain Interference and -Physical Function and legacy measures SRS-Pain, SRS-Activity. Responsiveness to change was measured with the adjusted effect size (aES). 325 patients were enrolled, with 208 completing baseline and one-year PROMs. The majority (149, 72%) were female and white (193, 93%), median Charlson Comorbidity Index 0 (IQR 0-2). The majority of cases included sagittal plane deformity (mean T1PA 24.2° (13.9). Cronbach's alpha showed excellent internal reliability (Baseline=0.89, 1yr=0.90). ODI was valid, with strong correlations between PROMIS-PI, -PF, SRS-Pain, and SRS-Activity at baseline and one-year follow-up. All measures were responsive to change, with the ODI showing greater responsiveness than PROMIS-PI, PROMIS-PF and SRS-Activity. The ODI is a valid measure of disability as measured by pain and function in patients with ASD. It is responsive to change in a manner not different from validated PROMIS-CAT or the SRS-22r legacy measure. It is multidimensional, however, as it assesses both pain and function simultaneously. It does not measure disability related to Self-Image and may not account for all disease-related disability in ASD patients.

The Relationship of Exercise, Psychosocial Factors, and Social Participation Among Adults Aging With Long-Term Physical Disability: A Cross-Sectional Study.

This study investigated the relationships among exercise engagement, psychosocial factors, and social participation for adults aging with physical disabilities (AAwPD). A cross-sectional study within a community-based cohort study of participation among AAwPD was conducted. A comprehensive survey was administered online or via telephone. Participants were 474 individuals between the ages of 45-65, primarily living in the Midwestern United States, who reported living with a physical disability for at least 5years. Survey questions created based on prior consolidation of activity domains assessed exercise engagement. Psychosocial health and social participation were measured using the Patient Reported Outcomes Measurement Information System. Chi-square tests, t-tests, and a general linear model were used to examine differences between exercisers and non-exercisers. Participants who exercised reported less pain (P < .001), fatigue (P < .001), and depression (P < .001) and greater self-efficacy for management of chronic conditions (P = .002), satisfaction with participation in social roles and activities (P < .001), and ability to participate in social roles and activities (P < .001) compared with non-exercising participants. AAwPD who exercised reported fewer secondary conditions and greater social participation. Although causal relationships cannot be drawn, and the frequency, duration, and intensity of exercise were not examined, this study lays important groundwork for future research to determine the health and participation benefits of exercise for AAwPD. Future studies should also focus on the development of exercise interventions to support successful aging with disability.

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial

ObjectiveTo evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition...

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.