Patient-Reported Outcomes Measurement Information System Research Articles

Initial Safety of Total Talus Replacement Used to Treat Talar Avascular Necrosis.

Total talus replacement (TTR) implants are designed to replace the diseased talar anatomy, reduce pain, maintain ankle range of motion, and restore ankle function after conservative treatments have failed. Currently TTR implants are produced by 3D printing a patient-specific implant designed from the patient's preoperative anatomy. TTR surgery using patient-specific implants is a relatively new technique that remains understudied in the literature. Therefore, the purpose of this investigation was to determine the early safety and potential benefit of the TTR implant in patients with talar avascular necrosis. This retrospective, multicenter, cohort study evaluates the safety and potential benefits of TTR using 3D-printed patient-specific implants across 4 US centers. The primary outcome was the occurrence of early adverse events after TTR surgery. Secondary outcomes including, pain, and physical function were assessed using the pain visual analog scale (VAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF), respectively. The study team analyzed 15 patients with more than 1 year of follow-up. The mean duration of follow-up was 25.9 months (range: 18.3-41 months). Although 33.3% (5 of 15) of patients experienced adverse events, primarily occurring within the initial 6 months postoperatively, 93% (14 of 15) of patients reported implant survivorship. Of the 5 cases (33.3%) resulting in an adverse event, 3 (60.0%) were determined to be unrelated to the subject device, 2 (40.0%) were determined to be possibly procedure-related, and none (0%) were determined to be device-related. Although further studies are needed to compare TTR with the standard of care, the results of this study demonstrate the relative early safety of TTR surgery using a 3D-printed implant for the treatment of challenging talar pathologies. A larger and longer clinical study is required to see if the efficacy of this approach will be statistically and clinically meaningful.

Fatigue levels and associated factors in systemic sclerosis: a cross-sectional study of 2,385 SPIN Cohort participants.

To compare fatigue in a large multinational systemic sclerosis (SSc) cohort to general population data and identify associated sociodemographic, lifestyle and SSc disease factors. Scleroderma Patient-centered Intervention Network Cohort participants completed the Patient-Reported Outcomes Measurement Information System-29 v2.0 fatigue domain. T-scores were compared with the USA general population (mean = 50; SD = 10). Multivariable linear regression was used to assess associations with sociodemographic, lifestyle, and disease-related variables. Among 2,385 participants (mean age 54.9 (SD = 12.6) years, 87% female, 38% diffuse SSc), mean fatigue T-score was 54.6 (SD = 11.0); 438 (18%) reported mild fatigue, 641 (27%) moderate, and 180 (8%) severe fatigue. Fatigue was independently associated with sociodemographic factors age (-0.10 points per year, [95% CI -0.14;-0.07]), male sex (-1.67 points, [-2.96;-0.37]), non-married status (0.97 points [0.04; 1.89]), and country (reference USA; France -2.35 points [-3.48;-1.21] and UK 2.38 points [0.80; 3.97]), and lifestyle factors smoking (4.16 points [2.52; 5.80]), alcohol consumption (-0.18 points per drink per week [-0.28;-0.07]), and body-mass index (0.34 points per unit [0.27; 0.42]). Fatigue was associated with disease-related factors gastrointestinal involvement (4.21 points [2.99; 5.43]), digital ulcers (1.51 points, [0.25; 2.77]), moderate small joints contractures (1.41 points [0.13; 2.69]), rheumatoid arthritis (4.34 points [2.37-6.31]) and Sjögren's syndrome (1.89 points [0.23; 3.55]). When pain was included in the model, its association was large (2.19 points [2.03; 2.34]) and interstitial lung disease was also associated (1.21 points [0.42; 2.00]). In people with SSc, fatigue scores were substantially higher than the general population and associated with multiple disease factors including gastrointestinal involvement, several painful disease manifestations, and lung involvement.

Initial Validation of AUGS-PERFORM: Construct Validity and Test-Retest Reliability.

The American Urogynecologic Society's Prolapse pERFORmance Measure (AUGS-PERFORM) patient-reported outcome measure contains 11 items designed to assess symptoms relevant for assessing the quality of treatment for pelvic organ prolapse. The aim of the study was to test AUGS-PERFORM's construct validity and test-retest reliability. For this prospective validation study, we recruited English-speaking adult participants, at a single academic institution, seeking care for pelvic organ prolapse. Participants completed AUGS-PERFORM, the Pelvic Floor Distress Inventory, and several Patient-Reported Outcomes Measurement Information System short forms at baseline. We compared the 11 AUGS-PERFORM items against items testing the same concepts on other questionnaires using percent agreement, kappa statistics, and linear regression to determine construct validity. Two weeks later and before any pelvic organ prolapse therapy, participants completed AUGS-PERFORM a second time. Test-retest reliability was assessed using intraclass correlation coefficients. We enrolled 148 participants between 27 and 86 years of age: 81% self-identified as White, 56% were sexually active, and 84% elected surgery for treatment. The AUGS-PERFORM items assessing bulge presence and bother had a high percent agreement with the Pelvic Floor Distress Inventory item #3 (83.5 and 70%, respectively). The percent agreement ranged from 69% to 75% for items assessing urinary and defecatory symptoms and from 49% to 56% for pain-related questions. Sexual function items had a strong negative correlation (expected direction based on scoring) with validated sexual function questionnaires. The intraclass correlation coefficient was estimated to be 0.86, indicating excellent test-retest reliability. The AUGS-PERFORM demonstrated good construct validity for prolapse, urinary incontinence, defecatory dysfunction, and sexual function questions, and moderate construct validity for pain-related questions. There was excellent test-retest reliability.

Measurement properties of the Brazilian-Portuguese version of the PROMIS-29 questionnaire and the Impact Score in patients with chronic low back pain

BackgroundA task force from the US National Institute of Health aimed to establish parameters for surveys with patients with chronic low back pain (LBP) by recommending the use of the Patient-Reported Outcome Measurement Information System 29-item (PROMIS-29) questionnaire and the stratification according to the Impact Score. We aimed to assess the internal consistency, reliability, measurement error, construct validity and responsiveness of the Brazilian-Portuguese version of the PROMIS-29 questionnaire (version 2.1) and the Impact Score in patients with chronic LBP.MethodsA prospective cohort study was carried out with patients with chronic LBP who were receiving physiotherapy treatment in clinics in São Paulo and Vitória cities, Brazil. The sample included 102 patients with chronic LBP, aged between 18 and 80 years, and with the ability to read and write in the Brazilian-Portuguese language. Exclusion criteria were patients with serious spinal conditions, cognitive impairment, pregnant women, and patients who had undergone lumbar surgery within the past six months. The PROMIS-29 questionnaire, the 12-item Short-Form Health Survey and the Roland-Morris Disability Questionnaire were applied. The PROMIS-29 questionnaire was reapplied after 24 hours and 4 weeks.ResultsThe PROMIS-29 questionnaire showed Cronbach’s Alpha values between 0.81 (anxiety) and 0.91 (depression). The ICC2.1 ranged from 0.85 (95% CI: 0.77 to 0.89) to 0,97 (CI 95%: 0.95 to 0.98). The SEM values ranged between 0.85 (physical function) and 2.62 (ability to participate in social roles and activities). The Impact Score showed Cronbach’s Alpha, ICC2.1 and SEM values of 0.91, 0.97 (95% CI: 0.95 to 0.98) and 0.56, respectively. The PROMIS-29 questionnaire and the Impact Score showed sufficient construct validity. The PROMIS-29 questionnaire showed moderate responsiveness, while the Impact Score showed sufficient responsiveness.ConclusionsBoth the Brazilian-Portuguese version of the PROMIS-29 questionnaire and the Impact Score showed sufficient internal consistency, reliability, construct validity and responsiveness in Brazilian patients with chronic LBP. The results support the US National Institutes of Health’s recommendation to use the PROMIS-29 questionnaire and the Impact Score in patients with chronic LBP. We suggest that future studies evaluate the structural validity of the Brazilian-Portuguese version of the PROMIS-29 questionnaire.Clinical trial numberNot applicable.

Early clubfoot recurrence can lead to more frequent and earlier second recurrences.

The frequency of multiple clubfoot recurrences following Ponseti casting and the effect on final outcomes have not been well studied. This study aims to evaluate the effect of early recurrence (during the first 2 years) on the timing and rate of subsequent recurrences. A retrospective review was conducted of children treated with Ponseti casting at a single institution from 2002 to 2023 with minimum follow-up until age 5. Patients who required comprehensive soft tissue surgery to obtain initial correction were excluded. Patient-Reported Outcomes Measurement Information System data were collected when available. A total of 86 patients were included; 69.8% (60) had idiopathic clubfoot. Average follow-up was 5.8 years. Early recurrence (recurrence before age 2) occurred in 26.7% (23). The rate of late recurrence (recurrence after age 2) was higher in the early recurrence group, 73.9% (17) vs. 39.7% (25), P = 0.005. Survival analysis revealed that patients with early recurrence experience late recurrence at a younger age of 3.9 vs. 6.7 years, P ≤ 0.001. The early recurrence group experienced more frequent recurrences, with a median of 3 [interquartile range (IQR): 1-5] total recurrences vs. 0 (IQR: 0-1), P ≤ 0.001. Patients with early recurrence had lower final mobility scores, 40.83 ± 10.88 vs. 48.00 ± 10.60, P = 0.029. In conclusion, this study suggests that early clubfoot recurrence leads to more frequent subsequent recurrence and earlier second recurrence. Patients with early recurrence had comparatively lower outcome scores, primarily due to multiple recurrences. Care providers could use this knowledge to educate parents about the natural history of recurrent clubfeet and emphasize the importance of brace compliance and routine monitoring.

Decision regret and long-term success rates after ventral buccal mucosa graft urethroplasty.

To characterise the long-term success rate of ventral onlay buccal mucosa graft urethroplasty (vBMG) in the management of bulbar urethral stricture disease (USD), assess patient-reported postoperative satisfaction and decision regret, and delineate clinical factors impacting patient-reported metrics. Patients with prior vBMG for bulbar USD, performed at Cleveland Clinic between 2003 and 2022, were contacted and brief structured interviews were performed. Stricture recurrence and need for secondary procedures, baseline demographics, and patient-reported outcome surveys were collected. The surveys included the Decision Regret Scale (DRS), the Urethral Stricture Symptom Impact Measure (USSIM) and the 10-item Patient-Reported Outcomes Measurement Information System Short Form, version 1.2 (PROMIS-10). Descriptive, univariate and multivariable analyses were performed for clinical outcomes and survey responses. A total of 104 patients recorded responses. The median patient age was 49 years and the median follow-up was 7.4 years at time of survey. The median graft length was 5 cm and 38% of patients underwent partial thickness augmented anastomotic urethroplasty. At time of follow-up, 10 patients underwent a secondary procedure. Moderate to severe regret on the DRS was found in 12% of patients, and greater regret was associated with recurrence. The mean physical and mental health PROMIS-10 Global Health T-scores were 52 and 53. The mean total USSIM score was 56. A significant correlation was found between USSIM and DRS scores, with higher DRS score and recurrence negatively impacting USSIM score. USSIM scoring across all domains was significantly worse in the moderate to severe DRS group. This study showed that vBMG for bulbar USD confers both high success rates and patient-reported satisfaction at extended follow-up, based on emerging and validated patient-reported outcome measures.

Assessing the measurement properties of PROMIS Computer Adaptive Tests, short forms and legacy patient reported outcome measures in patients undergoing total hip arthroplasty.

The commonly used ('legacy') PROMs evaluating outcomes of total hip arthroplasty (THA), have several limitations regarding their measurement properties and interpretation of scores. One innovation in PROMs is the use of Computerized Adaptive Testing (CAT). The Patient-Reported Outcomes Measurement Information System (PROMIS®) is a validated system of CATs. The aim of this study was to assess the measurement properties of PROMIS and legacy instruments in patients undergoing THA. Patients in this multicenter study filled out a questionnaire twice, including Dutch-Flemish PROMIS v1.2 Physical Function (PROMIS-PF) and v1.1 Pain Interference (PROMIS-PI) CATs and short forms, PROMIS v1.0 Pain Intensity, and legacy PROMs (Hip disability and Osteoarthritis Outcome Score (HOOS), HOOS-Physical function Shortform (HOOS-PS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Hip Score (OHS), and two numeric rating scales measuring pain). The reliability, measurement precision (Standard Error of Measurement (SEM)), smallest detectable change (SDC), and burden of PROMIS instruments were presented head-to-head to legacy PROMs. Furthermore, construct validity was assessed. 208 patients were included. All instruments had a sufficient test-retest reliability (range ICC: 0.83-0.96). The SEM of PROMIS CATs and short forms ranged from 1.8 to 2.2 T-score points, the SEM of legacy instruments 2.6-11.1. The SDC of PROMIS instruments ranged from 2.1 to 7.3 T-score points, the SDC of legacy instruments 7.2-30.9. The construct validity of PROMIS CAT and short forms were found sufficient, except for the PROMIS-PI short form. The burden of PROMIS CATs was smaller than PROMIS short forms (range 4.8-5.2 versus 8-20 items, respectively). The burden of legacy instruments measuring physical functioning ranged from 5 to 40 items. The PROMIS-PF is less burdensome, with high measurement precision, and almost no minimal or maximal scores, and an equal reliability compared to legacy instruments measuring physical functioning in patients undergoing THA. The PROMIS Pain Intensity 1a is comparable to the legacy pain instruments in terms of burden, reliability and SDC. Measuring the construct Pain Interference may not have additional value in this population because of its high correlation with instruments measuring physical functioning. The SDC values presented in this study can be used for individual patient monitoring.

Midterm Outcomes After Osteochondral Allograft Transplantation in the Knee Using High-Chondrocyte Viability Grafts.

Osteochondral allograft transplantation (OCAT) has become a standard-of-care treatment option for patients with large symptomatic articular defects. Recent advances in allograft science and OCAT protocols have been reported to result in consistently robust outcomes after OCAT in the knee. However, only short-term comparisons have been reported, and analyses are lacking for treatment failure risk factors that account for confounding variables. Midterm functional graft survival rate would exceed 80% for all OCATs combined, with consideration of risk factors for lower survivorship including older patient age, higher body mass index (BMI), tibiofemoral bipolar OCAT, and nonadherence to prescribed postoperative rehabilitation protocols. Case series; Level of evidence, 4. Patients with outcome data available at ≥5 years after primary OCAT using high chondrocyte-viability (HCV) osteochondral allografts were analyzed according to 2 clinically relevant definitions: (1) initial treatment failure, defined by revision or arthroplasty surgery performed for the primary OCAT at any time point during the study period; and (2) functional graft failure, defined by documented conversion to arthroplasty after primary or revision OCAT at any time point during the study period. Analyses were used to assess outcomes for each definition, separately for age group, sex, obesity status, tobacco use, type of OCAT surgery, osteotomy status, concurrent ligament surgery status, and adherence to postoperative protocols. Kaplan-Meier analyses were used to assess differences in survival rates, and Cox proportional hazards models were used to assess risk factors and multivariable relationships with survival. Patient-reported outcome measures for pain, function, mobility, and satisfaction were also analyzed. Analysis included 137 primary knee OCATs performed in 134 patients with a mean follow-up of 66 months (59 female, 75 male; mean age, 37.8 years; mean BMI, 28.5). The midterm (5- to 8-year) functional graft survival rate for patients undergoing primary OCAT in the knee using HCV grafts was 82% for all cases combined, ranging from 69% for tibiofemoral bipolar HCV OCATs to 89% for patellofemoral bipolar, 94% for multisurface unipolar, and 97% for single-surface unipolar. Initial treatment failure rates (revision or arthroplasty after primary OCAT) and OCAT nonsurvival rates (arthroplasty after primary or revision OCAT) were greater for older patient age, concurrent ligament reconstruction, tibiofemoral bipolar OCAT, and nonadherence to the prescribed postoperative rehabilitation protocols. When adjusted for patients' age, BMI, and tobacco use status, different surgery types did not demonstrate an increased risk for failure, while concurrent ligament reconstruction and nonadherence did. Patients who experienced functional graft survival after primary OCAT reported significantly greater improvements in PROMIS Physical Function and Mobility (Patient-Reported Outcomes Measurement Information System), International Knee Documentation Committee questionnaire, and Single Assessment Numeric Evaluation scores such that they were significantly higher at final follow-up as compared with patients who required arthroplasty. Patient-reported improvements in pain, function, and mobility exceeded minimal clinically important differences for ≥5 years after primary OCAT. When asked if they were satisfied with primary OCAT surgery, 76.2% of patients were very satisfied or satisfied with their results, while 8.5% were neutral and 15.4% were unsatisfied or very unsatisfied. With use of HCV osteochondral allografts, midterm (5- to 8-year) functional graft survival rates for patients undergoing primary OCAT in the knee were notably higher than previously reported midterm rates for traditional OCATs. When adjusted for patient characteristics, risk factors for nonsurvival included concurrent ligament reconstruction for knee instability and nonadherence to the prescribed postoperative rehabilitation protocols. Patients who experienced functional graft survival for ≥5 years after primary OCAT reported statistically significant and clinically meaningful improvements in pain, function, and mobility.

Comparative analysis of clinical outcomes of talocalcaneal coalition resection: subtalar joint middle and posterior facet involvement versus isolated posterior facet involvement – a retrospective cohort study

BackgroundDespite coalition resection being the preferred treatment for talocalcaneal coalition (TCC), postoperative complications, suboptimal functional recovery, and recurrence risks remain challenges. Although current TCC classification systems guide personalized surgical plans, the impact of middle and posterior facet coalitions on TCC resection surgery’s effectiveness is still poorly understood. Therefore, this study aims to compare the clinical outcomes of TCC patients with and without involvement of the subtalar joint’s (STJ) middle and posterior facets undergoing coalition resection to explore the potential impact of these coalitions on surgical outcomes.MethodsWe conducted a retrospective study on 115 patients who underwent coalition resection surgery due to symptomatic TCC between November 2009 and February 2023. According to preoperative CT scan results, patients were divided into an isolated posterior facet coalition (P-type) group and a middle-posterior facet coalition (MP-type) group. Demographic characteristics (including age, sex, body mass index (BMI), follow-up time, and medical history duration), pre-and postoperative assessments (including Visual Analog Scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Pain Interference (PI) and Physical Function (PF) scores from the Patient-Reported Outcomes Measurement Information System (PROMIS)), as well as postoperative self-assessment of efficacy (excellent, good, fair, poor) and hindfoot stiffness, were compared between the two groups. Postoperatively, TCC recurrence was evaluated through imaging follow-up examinations.Results69 patients meeting the inclusion criteria were included, with 30 patients in the P-type group and 39 in the MP-type group. There were no statistically significant differences between the two groups in demographic characteristics (P<0.05). There were also no statistically significant differences between the two groups in preoperative VAS score, AOFAS score, PI score, and PF score. However, postoperatively, there were statistically significant differences between the two groups in VAS score (1(1,1.5) vs. 2(1,2), P<0.01), AOFAS score (92.5(87,96.5) vs. 82(69.5,87), P<0.01), PI score (39(39,43) vs. 39(39,51), P = 0.014), PF score (73(61,73) vs. 55(51,73), P = 0.001), fair or poor outcome (4(13%) vs. 14(35.9%), P = 0.034), and hindfoot stiffness (3(10.3%) vs. 16(37.2%), P = 0.011). There was no statistically significant differences in the recurrence rate between the two groups postoperatively (0(0%) vs. 3(7.69%), P = 0.252).ConclusionEven with complete coalition resection during surgery and rehabilitation following standardized protocols, the surgical outcomes in MP-type TCC patients are still inferior to those in P-type patients.

The Benefits of an Integral HAMMAM Experience Combining Hydrotherapy and Swedish Massage on Pain, Subjective Well-Being and Quality of Life in Women with Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Trial

Background and Objectives: To evaluate the effectiveness of an integral HAMMAM experience, a 4-week therapeutic program that combined hydrotherapy and Swedish massage, applied in a multisensorial immersive environment, on pain, well-being and quality of life (QoL) in women with endometriosis-related chronic pelvic pain that is unresponsive to conventional treatment. Materials and Methods: This randomized controlled trial included 44 women with endometriosis. They were randomly allocated to either the ‘HAMMAM’ group (n = 21) or to a control group (n = 23). The primary outcome, pain intensity, was evaluated using numeric rating scales (NRSs). The secondary outcomes were pain interference, pain-related catastrophic thoughts, pressure pain thresholds (PPTs), subjective well-being, functional capacity and QoL, which were evaluated using the brief pain inventory (BPI), the pain catastrophizing scale (PCS), algometry, the subjective well-being scale-20 (EBS-20), the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) and the Endometriosis Health Profile-30 Questionnaire (EHP-30), respectively. The primary and secondary outcomes were measured at the baseline and after the intervention. The statistical (between-group analyses of covariance) and clinical effects were analyzed by the intention to treat. Results: The adherence rate was 100.0% and the mean (± standard deviation) satisfaction was 9.71 ± 0.46 out of 10. No remarkable health problems were reported during the trial. The ‘HAMMAM’ intervention improved dysmenorrhea and dyspareunia after the intervention with large and moderate effect sizes, respectively. Improvements in pain interference during sleep and PPTs in the pelvic region were also observed in women allocated to the ‘HAMMAM’ group. No effects were observed in catastrophizing thoughts, well-being nor QoL, except for the sleep subscale. Conclusions: A 4-week program of an integral ‘HAMMAM’ experience combining hydrotherapy and massage in a multisensorial immersive environment is a feasible and effective intervention to alleviate pain during menstruation and sexual intercourse as well as pain interference with sleep in women with endometriosis.

An open pilot of GROW, a responsive parenting intervention for young children with brain injuries: preliminary efficacy

Purpose Families experience stress and burden following their child’s traumatic brain injury (TBI). Parenting styles are related to parent stress and child behavior problems and executive dysfunction. Parent-child interactions are shown to be a promising intervention target. We aimed to examine the preliminary efficacy of Gaining Real life skills Over the Web (GROW) in improving responsive parenting and reducing parent stress and depression in parents of children ages 0-4 who experienced TBI. Method Participants (n = 11) were parents of children four years old or younger, at the time of enrollment, and previously hospitalized overnight for TBI. Parent-reported measures included the Center for Epidemiologic Studies Depression Scale, Parenting Stress Inventory—Short Form, and Patient-Reported Outcomes Measurement Information System. Recordings of parent-child interactions were coded using the Play and Learning Strategies coding scheme. Study hypotheses were analyzed using independent samples t-tests, chi square analyses, and linear mixed models. Results Parental warmth (t=-3.64, p = 0.001, d=.97), responsiveness (t=-2.09, p = 0.047, d = 0.70), and verbal stimulation (t=-2.30, p = 0.029, d = 0.75) increased significantly from pretreatment to posttreatment. Improvements in parental warmth were maintained 3 months posttreatment (t=-3.15, p = 0.004, d = 1.16). There were no significant changes in depression, parental stress, or quality of life. Conclusions Results provide preliminary support for the efficacy of GROW in improving responsive parenting for children following early TBI. Future directions include tailoring GROW to better fit the needs of families and testing the utility through a randomized control trial.

Association between maternal stress and child sleep quality: a nationwide ECHO prospective cohort study.

Childhood sleep quality is associated with physical, cognitive, and behavioral health and predicts later sleep quality; it has many determinants, including developmental exposures. To examine associations between maternal stress during pregnancy and childhood sleep quality and determine whether postnatal stress mediates the association. Data from the Environmental Influences on Child Health Outcomes cohort were used. Perceived Stress Scale (PSS) T-scores were the exposure measure. Outcome measures were preschool Child Behavior Checklist (CBCL) sleep syndrome scale and Patient-Reported Outcomes Measurement Information System Sleep Disturbance Parent Proxy short form 4a (PSD4a) T-scores at ages 4-8 years. Linear mixed-effects regression modeling was performed for each sleep outcome, adjusting for maternal age at delivery and education and child sex, gestational age at birth, and age at outcome ascertainment, with random intercepts for cohorts. Prenatal PSS score was associated with both CBCL (B = 0.09, 95% confidence interval [CI]: 0.06, 0.11; p < 0.01) and PSD4a (B = 0.07, 95% CI: 0.03, 0.12; p < 0.01) scores. Postnatal perceived stress mediated a proportion of the total effect of prenatal stress in both CBCL (66.3%) and PSD4a (95.9%) samples. Both pre- and postnatal maternal perceived stress appear to influence sleep quality during early life. Prenatal stress significantly associates with child sleep problems and disturbances at ages 4-8 years; postnatal maternal stress is a significant mediator of these associations. Research suggests a range of prenatal affective/distress exposures associated with child sleep problems, but the conclusions remain in doubt due to the mixture of exposures and outcomes employed. Ours is the first US-based effort to explore associations between perceived maternal stress during pregnancy and child sleep problems and disturbance in early and middle childhood. Even a small effect of a prevalent issue like psychosocial stress may have important public health implications at the population level.

Baseline Neck Disability Index and Patient-Reported Outcomes Measurement Information System Physical Function Predict Postoperative Return to Normal in Cervical Spine Surgery.

Recent studies assessing the importance of various preoperative factors on postoperative outcomes following spine surgery have uncovered several important variables that influence subjective and objective outcomes following cervical spine surgery, but it is still unclear which patients are most likely to benefit from operative management. The objective of this study was to assess whether preoperative patient-reported outcome measures (PROMs) can be used to predict which patients achieve "normal" levels of pain and function after surgery. This was a prospective cohort study. This study included all adult patients undergoing cervical spine surgery by 1 of 7 senior spine surgeons at our institution between 2016 and 2018. Of the 164 patients who were eligible for 6-month follow-up at the time that study data were collected, 139 had available follow-up data and were included in our analysis. Patients completed the Neck Disability Index (NDI) as well as the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference computer adaptive tests preoperatively and at 6 months postoperatively. Patients who achieved postoperative patient-acceptable symptom state (PASS) for NDI (≤17) and the normative mean (50) for PROMIS were identified. The relationship between preoperative PROMs and the probability of achieving PASS and the normative mean was assessed. One hundred thirty-nine patients met inclusion criteria with diagnoses of myelopathy (n = 36), radiculopathy (n = 48), and myeloradiculopathy (n = 49). For NDI, a 1-point worsening in the preoperative score resulted in an OR of achieving PASS of 0.96 (P < 0.001) in the overall population. This association held true for patients with radiculopathy (OR 0.96; P = 0.022) but not myelopathy (OR 0.98; P = 0.35). For PROMIS PF, a 1-point improvement in the preoperative score resulted in an OR of achieving the normative mean of 1.10 (P < 0.001). This association held true for patients with radiculopathy (OR 1.14; P = 0.033) but did not reach statistical significance for patients with myelopathy (OR 1.03; P = 0.515). Preoperative PROMs can predict postoperative benefit for patients undergoing cervical spine surgery, with worse baseline function associated with a lower likelihood of attaining PASS for NDI and the normative mean for PROMIS PF, especially for patients with radiculopathy. Baseline symptoms and function, including myelopathy or radiculopathy-dominant symptoms and preoperative PROMs, may predict postoperative outcomes.

Estimating Change in Health-Related Quality of Life before and after Stroke: Challenges and Possible Solutions.

Estimating change in health-related quality of life (HRQOL) from pre- to poststroke is challenging because HRQOL is rarely collected prior to stroke. Leveraging HRQOL data collected both before and after stroke, we sought to estimate the change in HRQOL from prestroke to early poststroke. Stroke survivors completed the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) scale at both pre- and early poststroke. Patient characteristics were compared for those who did and did not complete the PROMIS-GH. The mean change in PROMIS-GH T-score was estimated using complete case analysis, multiple imputation, and multiple imputation with delta adjustment. A total of 4,473 stroke survivors were included (mean age 63.1 ± 14.1 y, 47.5% female, 82.6% ischemic stroke). A total of 993 (22.2%) patients completed the PROMIS-GH at prestroke while 2,298 (51.4%) completed it early poststroke. Compared with those without PROMIS-GH, patients with PROMIS-GH prestroke had worse comorbidity burden. Patients who completed PROMIS-GH early poststroke had better early poststroke clinician-rated function and shorter hospital length of stay. Complete case analysis and multiple imputation revealed patients' PROMIS-GH T-scores worsened by 2 to 3 points. Multiple imputation with delta adjustment revealed patients' PROMIS-GH T-scores worsened by 4 to 10 points, depending on delta values chosen. Systematic differences in patients who completed the PROMIS-GH at both pre- and early poststroke suggest that missing PROMIS-GH scores may be missing not at random (MNAR). Multiple imputation with delta adjustment, which is better suited for MNAR data, may be a preferable method for analysis of change in HRQOL from pre- to poststroke. Given our study's large proportion of missing HRQOL data, future studies with less missing HRQOL data are necessary to verify our results. Estimating the change in health-related quality of life from pre- to poststroke is challenging because health-related quality-of-life data are rarely collected prior to stroke. Previously used methods to assess the burden of stroke on health-related quality of life suffer from recall bias and selection bias.Using health-related quality-of-life data collected both before and after stroke, we sought to estimate the change in health-related quality of life after stroke using statistical methods that account for missing data.Comparisons of patients who did and did not complete health-related quality-of-life scales at both pre- and poststroke suggested that missing data may be missing not at random.Statistical methods that account for data that are missing not at random revealed more worsening in health-related quality of life after stroke than traditional methods such as complete case analysis or multiple imputation.

Prevalence and Outcomes of Gastrointestinal Manifestations in an Australian Scleroderma Cohort.

The gastrointestinal tract (GIT) is the most commonly affected internal organ in systemic sclerosis (SSc). We sought to determine the prevalence and impact of GIT symptoms on survival and patient-reported outcomes. A total of 907 consecutive patients from the Australian Scleroderma Cohort Study who had prospectively completed the University of California, Los Angeles, Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 Questionnaire (UCLA GIT) between 2015 and 2021 were included. The associations between UCLA GIT scores and physical function (Scleroderma Health Assessment Questionnaire), quality of life (QoL; Short Form 36), mood (Patient-Reported Outcomes Measurement Information System [PROMIS] anxiety and depression domains), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score), and employment were investigated using multivariable population-averaged panel models using generalized estimating equations (GEEs). Kaplan-Meier curves and multivariable Cox proportional hazard regression models were used to evaluate survival according to total UCLA GIT scores. GIT symptoms were reported in 87% of participants, with 46% to 52% reporting moderate to very severe symptoms of reflux, distension, diarrhea, and constipation. Higher total UCLA GIT scores were associated with worse QoL, physical function, fatigue, anxiety, and depression (P < 0.001). In the multivariable GEE analysis, moderate and severe to very severe total scores, reflux scores, and distension scores were associated with worse physical function, QoL, fatigue, anxiety, and depression compared to mild scores (P < 0.05). Patients with severe total scores and diarrhea scores were more likely to be unemployed compared to those with mild scores (P < 0.05). UCLA GIT total scores were not independently associated with death in our cohort. GIT manifestations are common in SSc and negatively impact QoL, physical function, and employment but are not directly associated with increased death.

Does a Concise Patient-reported Outcome Measure Provide a Valid Measure of Physical Function for Cancer Patients After Lower Extremity Surgery?

Current functional assessment tools for orthopaedic oncology are long surveys that contribute to patients' survey fatigue and yet lack the ability to discern meaningful differences in a patient population that is often mobile but unable to perform strenuous activities. We sought to determine whether a shorter, novel tool based on existing, validated surveys could better capture differences in a sample of orthopaedic oncology patients. (1) Can a concise fixed-item functional tool derived from the 50 items in the Toronto Extremity Salvage Score for the lower extremity (TESS LE) and the Lower Extremity Functional Scale (LEFS) demonstrate similar responsiveness in terms of sensitivity and specificity? (2) What is the precision and accuracy of the concise tool compared with the TESS LE and LEFS? Functional outcome data were collected and maintained in a longitudinally maintained database at a single institution. Patients were included in the study if (1) they had undergone a tumor excision or a nononcologic orthopaedic procedure (for example, arthroplasty for osteoarthritis) for a bone or soft tissue tumor affecting lower extremity function, and (2) they had completed the LEFS, TESS LE, and Patient-Reported Outcomes Measurement Information System (PROMIS) global health tool on at least two clinic visits. Between September 2014 and April 2022, we treated 14,234 patients for primary bone or soft tissue sarcoma, metastatic disease to bone, or orthopaedic sequelae of chronic cancer care. Approximately 6% (854 of 14,234) were excluded due to the need of a language translator. Approximately 2% (278 of 13,380) refused or were unable to participate. Seventy-two percent (9433 of 13,102) of the patients had an operation on a lower extremity. Of these, 4% (339 of 9433) of the patients completed the TESS LE, LEFS, and Item 3 of the PROMIS global health tool on ≥ 2 clinic visits. Of the patients in the current study, 49% (167 of 339) were women, and 27% (93 of 339) had metastatic carcinoma. Twelve percent (41 of 339) of the patients died before the end of the study period. Spearman rank-order correlation, principal component analysis (PCA), and item response theory (IRT) modeling identified 14 highly discriminating items from the TESS LE and LEFS. Multiple linear stepwise regression (MLSR) was performed with the dependent variable being the summary score of the 14 items derived from the TESS LE and LEFS and standardized to a percentage of 100. The beta coefficient from the MLSR was used to derive a weight for each of the 14 items. Evaluation of the model with 10 to 17 variables was performed to ensure that the model with the 14 items met the most criteria for fit with the PCA, the receiver operating characteristic (ROC) curve, and the IRT modeling criteria. The responsiveness (sensitivity and specificity) of the change scores in the shortened 14-item survey, the 30-item TESS LE, and the 20-item LEFS as compared with the dichotomized changes in Item 3 of the PROMIS global health tool was evaluated using ROCs. The concordance (accuracy and precision) of the 14 items derived from the LEFS and TESS LE was evaluated. The responsiveness (sensitivity and specificity) of the shortened 14-item survey, the TESS LE, and the LEFS to the criterion target of the PROMIS global health tool (Item 3) was similar, with areas under the curve (AUCs) ranging from 0.62 to 0.65 for the ROC curves. The responsiveness of the 14-item survey to the TESS LE showed sensitivity of 96% and specificity of 90%, with an AUC of 0.98 (p < 0.001). The responsiveness of the 14 items to the LEFS showed sensitivity of 95% and specificity of 86%, with an AUC of 0.96. The validity of the 14 items to the TESS LE was measured by concordance, with a precision of 0.98 and an accuracy of 0.97. Concordance of the 14 items to the LEFS showed a precision of 0.98 and accuracy of 0.83. The concise 14 items derived from patient-reported responses in the TESS LE and LEFS outcome measures showed similar responsiveness (sensitivity and specificity) as the original TESS LE and LEFS for cancer patients after lower extremity orthopaedic surgery performed for oncologic and nononcologic indications. The concise 14 items have a similar ability to the TESS LE and LEFS to tell the clinician or patient how they are functioning compared with other patients. These 14 items are shorter than the combined 50 items of the TESS LE and LEFS while retaining the capacity to describe a broad range of lower extremity function for orthopaedic oncology patients. We have named the 14-item survey the Lower Extremity Oncology Functional Assessment Tool.Level of Evidence Level II, diagnostic study.

Impact of early onset colorectal cancer on mental and physical health: A comparative analysis of self-reported mental and physical health outcomes using the PROMIS framework in the NIH All of Us Research Program.

241 Background: Patients with early-onset colorectal cancer (EOCRC) have complex psycho-social needs that can impact their overall health and well-being. With the increasing incidence of EOCRC, it is essential to investigate the effects of this diagnosis on patients' mental and physical health. This study uses the Patient-Reported Outcomes Measurement Information System (PROMIS) framework to compare patients' self-reported mental and physical health perceptions with EOCRC and those with late-onset colorectal cancer (LOCRC). Methods: We utilized the National Institutes of Health's (NIH) All of Us database Registered Tier Dataset v7, which includes 266,520 participants who agreed to share their EHR information, for analysis. Participants completed PROMIS surveys for physical health (PROMIS-PH) and mental health (PROMIS-MH). We categorized patients with colorectal cancer into EOCRC (age at diagnosis &lt;50) and LOCRC (age at diagnosis &gt;=50) using ICD 9/10 codes. We calculated the raw summed scores for PROMIS-PH and PROMIS-MH for each group. We transformed the raw summed score into a T-score. The study compared scores in EOCRC and LOCRC using the Mann-Whitney U test with a significance level of P&lt;0.05. We used the R programming language in the web-based Jupyter Notebook platform for data analysis. Results: Our study revealed 1764 colorectal cancer patients, with 408 cases of EOCRC (mean age of onset: 42.13 years, SD: 7.0) and 1356 cases of LOCRC (mean age: 63.72 years, SD: 8.35). Analysis of PROMIS Global scores showed that EOCRC patients had a mean PROMIS-MH score of 13.90 (SD: 3.42, T-score: 45.8, 95% CI: 38.74-52.86) and mean PROMIS-PH score of 13.95 (SD: 3.38, T-score: 42.3, 95% CI: 34.07-50.53). In contrast, LOCRC patients had mean PROMIS-MH and PROMIS-PH scores of 14.47 (SD: 3.37, T-score: 48.3, 95% CI: 41.05-55.55) and 14.24 (SD: 3.35, T-score: 44.9, 95% CI: 36.47-53.33), respectively. The PROMIS-MH scores were significantly higher in LOCRC than in EOCRC (p-value &lt;0.001). However, there was no significant difference between the PROMIS-PH scores in both groups (p-value= 0.191). Conclusions: The study suggests that patients with EOCRC have a lower level of perceived mental health compared to LOCRC. Also, the EOCRC had a lower level of perceived physical health, although not statistically significant. These findings emphasize the significance of age-specific approaches in cancer research and underscore the importance of focused interventions to meet the unique mental and physical health needs of patients with EOCRC.

Living Donor Candidates’ Self-reported Health and Health Perceptions and Completion of Donor Evaluation: A Cohort Study

Rationale & ObjectiveGiven the organ shortage in the US, increasing living donation is vital to improving access to kidney transplantation, but many donor candidates do not complete the donor evaluation. Our objective was to understand potential living donors’ perceived health and its association with the likelihood of completing the donor evaluation process. Study DesignPotential donors’ self-reported health was ascertained using the Patient Reported Outcomes Measurement Information System (PROMIS) global physical and mental health and the Davies and Ware health perceptions surveys. Setting & ParticipantsPotential living donors who expressed interest in donation at a single medical center were recruited prospectively between 2017-2022. OutcomesCompletion of the donor evaluation. Analytical ApproachAdjusted linear and logistic regression models were used to examine the association between self-reported health and health perceptions with outcomes. Results1,347 individuals were included for study; 46% (N=613) were <40 years of age, 71% (N=951) female, 22% (N=294) were Hispanic, and 16% (N=215) completed the donor evaluation. Mean PROMIS global physical health (17.0 ± 1.9) and mental health (15.5 ± 2.7) raw scores were higher among donor candidates proceeding to completion of the donor evaluation compared with those who withdrew early in the process (16.3 ± 2.2 for physical health and 14.9 ± 3.1 for mental health). Every z-score change in the PROMIS physical health score was associated with 1.48-fold higher odds of completing the donor evaluation (95% CI 1.19-1.85). Fully adjusted models incorporating the PROMIS scores for predicting the completion of donor evaluations had a c-statistic of 0.70. Potential donors’ Davies and Wares health perceptions did not predict the likelihood of completing the donor evaluation in fully adjusted models. LimitationsData are derived from a single center and may not generalize to the donor evaluation process at other transplant centers. ConclusionsDonor candidates’ self-reported physical health may serve as a predictor of the likelihood of completing the donor evaluation process and a potential avenue for future interventions.

Outcomes of Ponseti Method for the Treatment of Clubfeet in Children With Spina Bifida.

While the Ponseti method is the primary treatment for idiopathic clubfoot, its application in treating myelodysplastic clubfeet is less certain. Myelodysplastic clubfoot tends to be more severe and difficult to treat. Although the Ponseti method can initially correct these cases, there is conflicting evidence about recurrence rates and the need for additional treatment. This study aims to assess the effectiveness of the Ponseti method in treating myelodysplastic clubfeet compared with idiopathic clubfeet over a 20-year period. The study conducted a retrospective review of medical records from patients treated for clubfoot at a single institution (2002 to 2021), comparing children with myelodysplastic and idiopathic clubfoot. Included patients were under 18, initially treated with Ponseti-casting, and had a minimum 2-year follow-up. Data on demographics, treatment details, recurrence, and Patient-reported Outcomes Measurement Information System (PROMIS) scores were analyzed. Forty-nine myelodysplastic and 512 idiopathic clubfeet in 366 patients met the inclusion criteria. Myelodysplastic cases had a median age of 5 months at presentation versus 2 months for idiopathic cases ( P =0.002). Initial correction was achieved in 95% of idiopathic and 87.8% of myelodysplastic feet ( P =0.185). Recurrence rates were higher in the myelodysplastic cohort, 65.3% versus 44.1% ( P =0.005). Surgery was necessary to treat recurrence in 59.2% of myelodysplastic and 37.7% of idiopathic cases, P =0.003. Follow-up was 3.9±1.8 years for myelodysplastic and 3.3±1.5 years for idiopathic feet, P =0.030. Myelodysplastic feet had lower PROMIS mobility scores; 31.94±7.56 versus 49.21±8.64, P <0.001. To the best of our knowledge, we report the largest series of myelodysplastic clubfeet treated by Ponseti casting and the first to assess PROMIS data. Overall, the Ponseti method is as effective in obtaining initial correction in myelodysplastic clubfoot as it is in idiopathic clubfoot. However, myelodysplastic clubfeet has a higher risk of relapse and increased need for surgical interventions. Children with spina bifida may need closer follow-ups and more stringent adherence to bracing. Level III-therapeutic studies-investigating the results of treatment.

The relationship between patient-reported experience and patient-reported outcomes in patients with cancer.

248 Background: Measures of patient experience (PEX) and patient-reported outcomes (PRO) are used by health systems across the US to improve care delivery and quality of life, respectively. Despite their widespread use, little is known regarding the relationship between these two types of patient-generated data. From 2018 to 2023, we conducted a pragmatic type-II hybrid effectiveness/implementation study of an electronic health record (EHR)-embedded symptom management program (eSyM) across six diverse cancer centers. This project focused on patients who started chemotherapy (CHEMO) or had surgery (SURG) for a suspected or confirmed gastrointestinal, gynecologic, or thoracic malignancy. Methods: We conducted a cross-sectional study of adults who were eligible for either the control or intervention arm of the eSyM study to determine if patients who reported having an inferior care-team experience were more likely to report having worse symptoms. Participants completed a one-time survey via REDCap that included elements from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and the Patient-Reported Outcomes Measurement Information System (PROMIS). Analyses determined the extent to which PEX measures were associated with PRO measures by evaluating differences in mean PROMIS scores for those who rated their PEX highly vs. not highly. Results: In total, 1419 respondents reported having cancer for which they received care at a participating center: median age 66, 63% female, 5% black, 13% disabled, 66% married/partnered, 23% high school or less education, 22% somewhat-extreme difficulty paying bills. For both CHEMO and SURG patients, 82% rated their overall cancer care-team experience highly (top box score of 9-10). Compared to patients who did not rate their care-team experience highly, those who did reported better scores for depression, fatigue, anxiety, pain interference, physical function, and self-efficacy (Table). PROMIS values differed for other CAHPS measures too. Conclusions: Among patients receiving routine cancer care, there was a significant association between PEX and multiple PROs. Further investigation of the nature and strength of the association between PEX and PRO measures is warranted. If confirmed, this association could lead to the development of interventions that impact both patient satisfaction and quality of life. Clinical trial information: NCT03850912 . Mean difference in PROMIS scores for patients who rated their care-team experience highly versus not highly (P from two-sample T-test). CHEMO (N=889) SURG (N=530) Mean Diff 95%CI P value Mean Diff 95%CI P value Depression -2.7 -4.3, -1.1 0.001 -3.3 -5.3, -1.4 &lt;0.001 Anxiety -3.7 -5.4, -1.9 &lt;0.001 -3.6 -5.7, -1.5 &lt;0.001 Fatigue -2.3 -4.0, -0.5 0.011 -4.5 -6.8, -2.2 &lt;0.001 Pain interference -3.6 -5.3, -1.9 &lt;0.001 -4.7 -6.7, -2.7 &lt;0.001 Physical function 1.6 0.1, 3.1 0.042 3.5 1.4, 5.6 0.001 Self-efficacy 3.9 2.6, 5.2 &lt;0.001 6.4 4.6, 8.1 &lt;0.001