Patient-Reported Outcomes Measurement Information Research Articles

Early Radiographic and Clinical Outcomes of an Additive-Manufactured Acetabular Component

BackgroundAdditive manufacturing has recently gained popularity and is widely adopted in the orthopaedic industry. However, there is a paucity of literature on the radiographic and clinical outcomes of these relatively novel components. The aim of this study was to assess the 2-year clinical and radiographic outcomes of a specific additive-manufactured acetabular component in primary total hip arthroplasty. MethodsWe performed a retrospective review of 60 patients who underwent primary total hip arthroplasty with the use of the Stryker’s TRIDENT II acetabular component. Evaluation of radiographs was performed at 6 weeks, 1 year, and 2 years postoperatively. Radiographs were evaluated for radiolucencies in Charnley and DeLee zones, signs of biologic fixation, and acetabular inclination and anteversion measurements. Patient-reported outcomes and complications were also obtained. ResultsThere were no cases of component loosening or changes in component position during follow-up, with an average follow-up time of 1.7 years. A radiolucent line was identified in one patient in zone 1 at 6 weeks; this was absent at 1 year. Radiographic signs of cup biologic fixation were present in 85% of cases by final follow-up. The average inclination was 45.1 (SD = 4.0), and the average anteversion was 26.9 (SD = 5.2). Patient-Reported Outcomes Measurement Information System scores significantly increased at the final follow-up, and there were no complications in this cohort. ConclusionsThis study demonstrated excellent radiographic and clinical outcomes with this novel additive-manufactured acetabular component at early follow-up. Although longer-term follow-up is warranted, this additively manufactured highly porous titanium acetabular component demonstrated excellent biologic fixation and reliable fixation at mid-term follow-up.

Preoperative Function Affects Ability to Achieve One-Year Minimum Clinically Important Difference for Patients Undergoing Total Knee Arthroplasty

BackgroundMinimum clinically important difference (MCID) values are commonly used to measure treatment success for total knee arthroplasty (TKA). MCID values vary according to calculation methodology, and prior studies have shown that patient factors are associated with failure to achieve MCID thresholds. The purpose of this study was to determine if anchor-based 1-year Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS-JR) MCID values varied among patients undergoing TKA based on patient-specific factors. MethodsThis was a retrospective review of patients undergoing TKA from 2017-2018. Patients without baseline or 1-year KOOS-JR or Patient-Reported Outcome Measurement Information System Global Health data or that underwent procedures other than primary TKA were excluded. MCIDs were calculated and compared between patient groups according to preoperative characteristics. ResultsAmong the included 976 patients, 1-year KOOS-JR MCIDs were 26.6 for men, 28.2 for women, 30.7 for patients with a diagnosis of anxiety and/or depression, and 26.7 for patients without a diagnosis. One-year MCID values did not differ significantly according to gender (P = .379) or mental health diagnosis (P = .066), nor did they correlate with body mass index (β = −0.034, P = .822). Preoperative KOOS-JR decile demonstrated an inverse relationship with 1-year MCID values and attainment of MCID. ConclusionsThe proportion of patients attaining KOOS-JR MCID values demonstrated an inverse relationship with preoperative baseline function. Future investigation may identify patient factors that allow surgeons to better capture patient satisfaction with their procedure despite failure to attain a 1-year MCID.

The influence of body mass index on patient-reported outcome measures following total hip arthroplasty: a retrospective study of 3,903 Cases.

The influence of obesity on patient-reported outcome measures (PROMs) following total hip arthroplasty (THA) is currently controversial. This study aimed to compare PROM scores for pain, functional status, and global physical/mental health based on body mass index (BMI) classification. Primary, elective THA procedures at a single institution between 2018 and 2021 were retrospectively reviewed, and patients were stratified into four groups based on BMI: normal weight (18.5-24.99kg/m2), overweight (25-29.99kg/m2), obese (30-39.99kg/m2), and morbidly obese (> 40kg/m2). Patient-Reported Outcome Measurement Information System (PROMIS) and Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) scores were collected. Preoperative, postoperative, and pre/post- changes (pre/post-Δ) in scores were compared between groups. Multiple linear regression was used to assess for confounders. We analyzed 3,404 patients undergoing 3,903 THAs, including 919 (23.5%) normal weight, 1,374 (35.2%) overweight, 1,356 (35.2%) obese, and 254 (6.5%) morbidly obese cases. HOOS, JR scores were worse preoperatively and postoperatively for higher BMI classes, however HOOS, JR pre/post-Δ was comparable between groups. All PROMIS measures were worse preoperatively and postoperatively in higher BMI classes, though pre/post-Δ were comparable for all groups. Clinically significant improvements for all BMI classes were observed in all PROM metrics except PROMIS mental health. Regression analysis demonstrated that obesity, but not morbid obesity, was independently associated with greater improvement in HOOS, JR. Obese patients undergoing THA achieve lower absolute scores for pain, function, and self-perceived health, despite achieving comparable relative improvements in pain and function with surgery. Denying THA based on BMI restricts patients from clinically beneficial improvements comparable to those of non-obese patients, though morbidly obese patients may benefit from additional weight loss to achieve maximal functional improvement.

#2528 Comparing patient-reported and performance-based physical function assessments in hemodialysis: insights from the CONVINCE trial

Abstract Background and Aims Physical function is a crucial outcome in nephrology. In alignment with the Patient-Reported Outcomes Measurement Information System (PROMIS) Initiative, physical function is characterized as the ability to execute activities involving physical actions, ranging from self-care to more complex activities, such as social activities. This definition of physical function spans various domains of the International Classification of Functioning, Health, and Disability (ICF). The assessment of physical function commonly employs two distinct approaches, patient-reported outcomes (PRO) and observed performance outcomes (PerfO). PRO and PerfO assessments have distinct advantages and limitations and were found to correlate only moderately, adding complexity to cross-instrument outcome comparisons and interpretation. Despite this, there is limited understanding of the factors contributing to the discordance between PRO and PerfO assessments in patients with kidney disease. In this study, we applied a previously established common T-score metric for patient-reported and performance-based physical function to compare patterns of associations with potential laboratory-based, psychosocial, sociodemographic, and health-related determinants in hemodialysis patients. Method Cross-sectional data from the baseline assessment of the CONVINCE trial (N = 1,132), a multinational randomized controlled trial comparing high-dose hemodiafiltration with high-flux hemodialysis, were analysed. To investigate the relationships between potential determinants and performance-based versus patient-reported physical function, we performed multiple linear regression analysis. Dependent variables were standardized T-scores derived from the PROMIS physical function short-form 4a (PRO) and the Physical Performance Test (PerfO). Both measures assess a generic concept of physical function. We compared the effect sizes of each potential determinant in the multiple regression model using partial f2 values, with thresholds of 0.02, 0.15, and 0.35 denoting small, medium, and large effects. Results Both, PerfO and PRO exhibited significant associations with a laboratory marker-based indicator of muscle mass (simplified creatinine index), albeit with relatively small effects (partial f² of 0.04 and 0.05, respectively). None of the other laboratory measures investigated in this study showed any relevant associations with physical functioning. Age demonstrated a negative association with physical function, with a larger effect size observed for performance-based (partial f² = 0.11) compared to patient-reported physical function (partial f² = 0.04). In contrast to performance-based physical function, patient-reported physical function displayed a stronger association with self-reported health domains, particularly pain interference and fatigue. Exploring the differences between patient-reported and performance-based T-scores at the individual level, we found that younger age and more cognitive/emotional fatigue were associated with lower patient-reported compared to performance-based physical function (small effect sizes). Conclusion PRO and PerfO assessments of physical function in hemodialysis patients had similar associations with the simplified creatinine index, suggesting comparable links to objective physical impairment. However, PRO-based physical function exhibited a notably stronger association with other patient-reported variables, suggesting that patient-reported constructs of physical function might represent more than just capability, but ‘capability free from symptomatic constraints’. This distinction should be taken into account when directly comparing or aggregating PRO and PerfO scores. A noteworthy aspect of our study is the utilization of a common T-score metric for both PRO and PerfO measures. This method enhances interpretability of results and facilitates comparisons across diverse assessment types, thereby offering valuable insights into the determinants of physical function in patients undergoing hemodialysis.

Leading Stressors and Coping Strategies Associated With Maternal Physical and Mental Health During the Extended Postpartum Period.

A critical gap exists in understanding stressors and coping that affect women's health beyond 6 weeks postpartum. Using new stressor and coping scales tailored to postpartum women, we examined the relationship of postpartum-specific stressors and coping to women's physical and mental health between 2 to 22 months after childbirth. A total of 361 women of diverse race, ethnicity, and functional abilities recruited through clinical and online methods completed online surveys that included Sources of Stress-Revised subscales, such as overload, changes after pregnancy, and low support resources; Postpartum Coping Scale subscales, such as self-regulation, self-care, and health promotion; Patient-Reported Outcomes Measurement Information System Global Health, covering physical and mental health dimensions; and social demographic items. Analyses included hierarchical linear regression models adjusted for social factors. Education and employment were the only social factors associated with physical and mental health, respectively. After adjusting for social factors, overload (P <.001) and coping through health promotion (P =.020) were the only additional variables associated with physical health. After adjusting for social factors, overload (P <.001) and low support resources (P =.002) and coping through self-care (P =.036) were the only additional variables associated with mental health. Thus, being overloaded was the key stressor associated with decreases in physical and mental health. Health promotion was associated with increases in physical health, and self-care was associated with increases in mental health. These findings point to directions for health care and community interventions to promote health for postpartum women under stress. Strengths of our study include application of stress and coping scales tailored to postpartum women, whereas a limitation is use of a cross-sectional design.

Cognitive-Behavioral-Based Physical Therapy for Improving Recovery After a Traumatic Lower-Extremity Injury: The Results of a Randomized Controlled Trial.

Lower-extremity injuries can result in severe impairment and substantial years lived with a disability. Persistent pain and psychological distress are risk factors for poor long-term outcomes and negatively influence the recovery process following a traumatic injury. Cognitive-behavioral therapy (CBT) interventions have the potential to address these risk factors and subsequently improve outcomes. This study aimed to evaluate the effect of a telephone-delivered cognitive-behavioral-based physical therapy (CBPT) program on physical function, pain, and general health at 12 months after hospital discharge following lower-extremity trauma. The CBPT program was hypothesized to improve outcomes compared with an education program. A multicenter, randomized controlled trial was conducted involving 325 patients who were 18 to 60 years of age and had at least 1 acute orthopaedic injury to the lower extremity or to the pelvis or acetabulum requiring operative fixation. Patients were recruited from 6 Level-I trauma centers and were screened and randomized to the CBPT program or the education program early after hospital discharge. The primary outcome was the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) scale. The secondary outcomes were objective physical function tests (4-square step test, timed stair ascent test, sit-to-stand test, and self-selected walking speed test), PROMIS Pain Intensity and Pain Interference, and the Veterans RAND 12-Item Health Survey. Treatment effects were calculated using targeted maximum likelihood estimation, a robust analytical approach appropriate for causal inference with longitudinal data. The mean treatment effect on the 12-month baseline change in PROMIS PF was 0.94 (95% confidence interval, -0.68 to 2.64; p = 0.23). There were also no observed differences in secondary outcomes between the intervention group and the control group. The telephone-delivered CBPT did not appear to yield any benefits for patients with traumatic lower-extremity injuries in terms of physical function, pain intensity, pain interference, or general health. Improvements were observed in both groups, which questions the utility of telephone-delivered cognitive-behavioral strategies over educational programs. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

#2502 The CONVINCE randomized trial found positive effects of hemodiafiltration on quality of life in patients with kidney disease on dialysis

Abstract Background and Aims Health-related quality of life of ESKD patients is negatively affected by disease-specific symptoms and can additionally be impaired by renal replacement therapy. Previous studies indicate that hemodiafiltration (HDF) may have a positive impact on the patients’ perceived health status compared to hemodialysis (HD), but overall evidence has been inconclusive. We investigated whether HDF is beneficial with respect to the patients’ perceived health status in the CONVINCE Trial. Method The CONVINCE Trial is an international multi-center, prospective, randomized, open label, controlled trial, comparing benefits and safety high-dose HDF versus high-flux HD. All-cause mortality was the primary outcome of the trial and a broad range of Patient-Reported Outcomes (PROs) were investigated as secondary outcomes. Eight generic health domains (Physical Function, Pain Intensity, Pain Interference, Fatigue, Sleep Disturbance, Depression, Anxiety, Ability to Participate in Social Roles and Activities) were assessed using the Patient-Reported Outcome Measurement Information System, PROMIS®-29 v2.0 profile, and an additional PROMIS short-form assessing Cognitive Function. PROs were collected every three months over the course of the study. As the perceived health status is likely related to mortality, we estimated the effect of HDF on PROs using a joint modelling approach to account for potential bias by selective dropout due to death. Results A total of n = 1 360 patients have been randomized to HD (n = 677) and HDF (n = 683). Both groups were comparable at baseline, with physical function (44.0 on the PROMIS T-score metric) considerably lower than the general population. Median follow-up was 30 months. We could obtain 84% of the planned PRO follow-up assessments on average. Overall, we found a steady decline in Health-Related Quality of Life (HRQoL) over the observation period; with statistically significant group differences for Physical Function (P = .047), Cognitive Function (P = .049), Pain Interference (P = .027) and the Ability to Participate in Social Roles and Activities (P = .023), all favouring HDF over HD. Conclusion Within the CONVINCE trial we have applied a comprehensive assessment of PROs comparing HDF with HD. Along with a beneficial effect on survival rates, we observed a slower decline in patients perceived health status when treated with HDF compared to HD. CONVINCE provides further evidence that HDF is beneficial in terms of quality of life.

#2947 Exploring various approaches for assessing fatigue in patients receiving hemodialysis using the CONVINCE study population

Abstract Background and Aims In nephrology, there is a growing interest in identifying patients’ priorities to achieve meaningful outcomes. A particular relevant outcome in end stage kidney disease is fatigue, with prevalence ranging from 60% to 97% in patients receiving hemodialysis. Different approaches for assessing fatigue exist. The objective of this study was to investigate how self-reported peri-/intra-dialytic and post-dialysis fatigue relate to overall fatigue levels and to certain risk factors of patients receiving hemodialysis. Method The CONVINCE trial is an international multi-center, prospective, randomized, open label, controlled trial, comparing all-cause mortality of high-flux hemodialysis with high-dose hemodiafiltration. Patient-related outcomes (PROs) were examined as secondary outcomes. Fatigue was assessed using tailored short forms from the Patient-Reported Outcome Measurement Information System (PROMIS) to measure overall fatigue, the newly developed Convince Dialysis Fatigue Scale (CDFS) to capture peri-/intra-dialytic fatigue and the Convince Time to Recovery (CTTR-1) to measure post-dialysis fatigue. PROs were collected every 3 months for 24 months, except for CTTR-1 and a PROMIS fatigue short form, which were collected on a monthly basis from the 1st to 5th months. To investigate the agreement between overall fatigue, peri-/intra-dialytic and post-dialysis fatigue, Spearman's correlation was calculated. In addition, we examined whether general health, depression, physical function, sex and dialysis vintage were related to peri-/intra-dialytic, post-dialysis and overall fatigue in a cross-sectional study design (irrespective of dialysis modality). To test for change over time as well as differences between groups Cohen's d effect sizes were calculated. Results Data for PROs was collected from 1282 participants at baseline and 804 after 24 months. The PROMIS fatigue score and the CDFS correlated strongly at each measurement point (Spearman r≥0.67). The PROMIS fatigue score and CTTR-1 correlated moderately (Spearman r≥0.41). We found large effect sizes for mean differences for peri-/intra-dialytic fatigue between patients with/without at least mild depression (Cohen's d 1.27 (95%CI 1.11 to 1.44)) as well as between patients with/without at least moderately impaired physical function (Cohen's d 1.04 (95% CI 0.89 to 1.19)). Patients, who reported CTTR-1 ≥12 hours, showed also large effect sizes for mean differences for overall fatigue between patients with/without at least mild depression (Cohen's d 0.9 (95% CI 0.48 to1.39)) as well as between patients with/without at least moderately impaired physical function (Cohen's d of 1.1 (95% CI 0.7 to 1.67)). In almost half of the patients, the time to recovery was &amp;gt; 4 hours, and patients who reported having to recover for a longer time after dialysis were, on average, more fatigued overall. Overall fatigue, with an observed mean change of 2.10 (SD 9.69) of PROMIS fatigue score, and peri-/intra dialytic fatigue, with an observed mean change of 1.98 (SD 6.98) of CDFS, showed a small increase over the study course. Prevalence of clinically relevant overall fatigue, as defined by a PROMIS fatigue score ≥59, was 15.9% at baseline and increased to 19.8 % after 24 months. Conclusion The three fatigue measurements correlated moderately to strongly and showed small change over time. The relations of various risk factors with fatigue, including self-reported depression, were similar, irrespective of the measure used, indicating that the discrimination between these constructs is imperfect. Furthermore, we discovered that the overall level of fatigue in the study population was comparable to the general population and the prevalence of clinically relevant fatigue was less than reported previously. This is surprising, given the emphasis on fatigue as a significant outcome for patient receiving dialysis. To assess the experience and impact of fatigue in patients receiving hemodialysis, greater attention is warranted, particularly in the timing of fatigue, the time span studied, and the severity of fatigue, especially when investigating a specific fatigue treatment.

Readability Analysis of Spanish-Language Patient-Reported Outcome Measures in Orthopaedic Surgery.

Patient-reported outcome measures (PROMs) are increasingly used to quantify patient symptomatology when assessing intervention effectiveness as well as to guide patient-centered health-care management and research. Previous studies have analyzed the readability of PROMs used in orthopaedics in the English language; however, the readability of PROMs used in orthopaedics in the Spanish language has not been evaluated. Given the increasing number of Spanish-speaking individuals seeking orthopaedic care in the United States, it is imperative that PROMs are at an adequate reading level for patients to answer appropriately in their native language. This study aimed to assess the readability of publicly available Spanish-language PROMs used in orthopaedics. Searches of the PubMed, Google Scholar, and Embase databases were conducted to identify publicly available Spanish-language versions of PROMs used in orthopaedics. Additionally, the PROMIS Health Organization was contacted to obtain Spanish-language versions of the PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires. A total of 42 Spanish-language PROMs were identified and included in this study. The text of each PROM was inserted into multilingual readability software (legible.es), which analyzed the readability of each PROM using the Fernández Huerta and Índice de Legibilidad de Flesch-Szigriszt (INFLESZ) readability formulas. The mean and standard deviation (SD) of the raw readability scores were calculated for the PROMs. The percentage of PROMs at or below the 6th-grade reading level was also calculated. The mean readability of PROMs using the INFLESZ formula was at a 7th to 10th-grade reading level (mean = 63, SD = 16), and the mean readability using the Fernández Huerta formula was 68 (SD = 15). On average, 57% of the PROMs used in orthopaedics were at or below the INFLESZ 6th-grade readability level. Approximately half of Spanish-language PROMs used in orthopaedics are written at a reading level that does not meet the National Institutes of Health and the American Medical Association recommendations at or below the 6th-grade level. PROM developers and translators should consider the importance of readability when translating PROMs, to maximize their use and efficacy among orthopaedic patients speaking that language.

Novel CHATogether family-centered mental health care in the post-pandemic era: a pilot case and evaluation

BackgroundThe COVID-19 pandemic impacted children, adolescents, and their families, with significant psychosocial consequences. The prevalence of anxiety, depression, and self-injurious behaviors increased in our youth, as well as the number of suicide attempts and hospitalizations related to suicidal ideation. Additionally, parents’ mental health saw increasing rates of depression, irritability, and alcohol use combined with worsening family function, child-parent connectedness, positive family expressiveness, and increases in family conflict. In light of these statistics, we created CHATogether (Compassionate Home, Action Together), a pilot family-centered intervention using multi-faceted psychotherapeutic approaches to improve familial communication and relational health between adolescents and their parents. This paper discusses the implementation of the CHATogether intervention at the Adolescent Intensive Outpatient Program (IOP), providing an example of the intervention through an in-depth pilot case, and evaluation of the program’s acceptability and feasibility.MethodsThis paper describes a case in detail and evaluation from a total of 30 families that completed CHATogether in the initial pilot. Each family had 4–6 one-hour CHATogether sessions during their 6-week treatment course at the IOP. Before and after CHATogether, adolescents and their parents separately completed a questionnaire designed to explore their perceived family conflicts. After completion of the program, participants completed a brief quality improvement survey to assess their overall experience with CHATogether. In the reported case, the family completed Patient-Reported Outcomes Measurement Information System (PROMIS) depressive and anxiety symptoms scales, Conflict Behavior Questionnaires (CBQ), 9-item Concise Health Risk Tracking Self-Report (CHRT-SR9), and help-seeking attitude from adults during distress and suicide concerns.ResultsThe pilot case showed a trend of improvement in reported depressive and anxiety symptoms, child-parent conflicts, subfactors of suicide risk including pessimism, helplessness, and despair, help-seeking acceptability from parents for suicide concerns, and the establishment of individualized family relationship goals. Preliminary feedback from participating families demonstrated positive effects on intra-family communication and improvement in the overall family dynamic. Adolescents (n = 30/30) and their parents (n = 30/30) rated “strongly agree” or “agree” that their families had benefited from CHATogether and welcomed participation in future program development.ConclusionThis study presents CHATogether as a novel family-centered intervention to address post-pandemic family mental health stress, especially when a family system was disrupted and negatively affected the mental health of children and adolescents. The intervention facilitated positive child-parent communication on a variety of topics, through tools such as emotional expression and help-seeking behavior. The reported pilot case and evaluation suggested CHATogether’s acceptability and feasibility in a clinical context. We also provided quality improvement feedback to guide future studies in establishing the efficacy of CHATogether and other similar models of clinical family interventions.

Association Between Symptoms of Anxiety and Depression, Hip Pathology, and Patient-Reported Outcomes After Hip Arthroscopy for Femoroacetabular Impingement.

In patients with femoroacetabular impingement (FAI), mental health has been implicated in both symptom severity and postoperative outcomes. However, there are limited data regarding the independent influences of baseline mental health and hip pathology on patient-reported outcomes over time after hip arthroscopy. To evaluate the association between mental health and structural hip pathology with pain, hip function, and quality of life (QOL). Cohort study; Level of evidence, 3. Patient records from a single surgeon's hip outcomes registry were retrospectively reviewed. Mental health was evaluated using the Patient-Reported Outcomes Measurement Information System Anxiety and Depression scores. Pain was evaluated with the Single Assessment Numeric Evaluation score for Activities of Daily Living (SANE-ADL), while hip-related QOL was evaluated with the 12-item International Hip Outcome Tool (iHOT-12). Hip function was assessed with the Hip Outcome Score (HOS) Sport-Specific (SS) and ADL subscales. Separate mixed models were used to predict pain, QOL, and hip function, including hip pathology measures (size of labral tear, grade of chondral damage, preoperative alpha angle), anxiety, depression, and time as fixed effects and individuals as a random effect. A total of 312 patients were included in this study. The preoperative alpha angle, degree of intraoperative cartilage damage, and size of the labral tear were not associated with pain or QOL (P > .05 for all). However, higher levels of anxiety and depression were significantly associated with lower SANE-ADL scores (estimate ± SE) (anxiety: -0.59 ± 0.07, P < .0001; depression: -0.64 ± 0.08, P < .0001), iHOT-12 scores (anxiety: -0.72 ± 0.07, P < .0001; depression: -0.72 ± 0.08, P < .0001), HOS-SS scores (anxiety: -0.68 ± 0.09, P < .0001; depression: -0.57 ± 0.10, P < .0001), and HOS-ADL scores (anxiety: -0.43 ± 0.05, P < .0001; depression: -0.43 ± 0.06, P < .0001). Patients had similar improvements in pain scores, QOL, and hip function after hip arthroscopy for FAI irrespective of their degree of hip pathology. Additionally, preoperative symptoms of anxiety and depression symptoms were associated with greater pain, decreased QOL, and worse hip function both pre- and postoperatively, independent of the degree of hip pathology. This suggests that efforts to directly address symptoms of anxiety and depression may improve outcomes after hip arthroscopy.

Granulomatosis With Polyangiitis (Wegener's) Nasal Reconstruction: Improved Outcomes With No Surgical Delay.

Granulomatosis with polyangiitis (Wegener's) causes progressive nasal collapse, nasal obstruction, and central face deformity. It is not known whether cartilaginous nasal reconstruction should be performed immediately or delayed (after disease 'burn-out'). For Wegener's nasal collapse to: (1) Assess the functional and aesthetic outcomes following immediate versus delayed nasal reconstruction; (2) Measure the impact of psychosocial well-being (anxiety, depression, social isolation) in immediate versus delayed nasal reconstruction. Wegener's patients were compared with either 1) immediate or 2) delayed nasal surgery (n = 61). Functional and aesthetic severity were compared with the validated Standard Cosmesis and Health Nasal Outcome Survey (SCHNOS) score (student's t-test). In addition, Patient-Reported Outcomes Measurement Information System (PROMIS) perioperative/1-year follow-up surveys were analyzed. At initial consultation, SCHNOS score severity types were similar for each group (Immediate vs Delayed): Mild (15% vs. 15%), Moderate (59% vs. 60%), and Severe (26% vs. 25%). Over a 30 ± 4 month wait, Delayed Surgery patients' conditions deteriorated with a shift from mild to more severe SCHNOS scores: Initial consultation vs. Prior to surgery (25 to 85). PROMIS scores at presentation were high compared to the general public; by the time of Delayed Surgery, patients significantly worsened: Anxiety (28 to 73), Depression (18 to 62), and Social Isolation (20 to 80). Although both immediate and delayed groups improved after surgery in functional and psychosocial scores, the immediate group was superior. Data showed superior functional/aesthetic scores, and superior psychosocial indicators with immediate cartilaginous nasal reconstruction compared to waiting until disease 'burn-out'.

Humeral Component Version Has No Effect on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial.

Controversy exists regarding the ideal humeral component version to optimize humeral rotation and patient outcomes in reverse total shoulder arthroplasty (rTSA). Patients undergoing primary rTSA for rotator cuff tear arthropathy, a massive rotator cuff tear, or primary osteoarthritis with a rotator cuff tear were randomized to placement of the humeral component in neutral version or 30° of retroversion. Shoulder active range of motion and strength and visual analog scale (VAS) pain, American Shoulder and Elbow Surgeons (ASES), and Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) scores were collected up to 2 years postoperatively. The goal of the study was to determine whether humeral external rotation and internal rotation are affected by humeral component version following rTSA at 2 years postoperatively. Sixty-six patients were included in the analysis. The median follow-up was 26 months for the neutral and 27 months for the 30° retroversion group. No differences between the groups were observed with respect to the primary diagnosis, sex, age, body mass index, or American Society of Anesthesiologists (ASA) class. The 2 groups did not differ significantly in terms of improvement at 2 years in active shoulder abduction (p = 0.969), forward elevation (p = 1.000), internal rotation measured as the highest spinal level reached (p = 1.000), internal rotation with the arm abducted 90° (p = 0.451), external rotation (p = 0.362), or muscle strength in forward elevation (p = 1.000), abduction (p = 1.000), external rotation (p = 0.617), or internal rotation (p = 1.000). The 2 groups did not differ significantly in terms of improvement in postoperative ASES (p = 1.000), PROMIS-10 physical (p = 1.000), or VAS pain scores (p = 0.718) at the time of final follow-up. In the neutral version group, 1 patient underwent revision for instability and 1 for stiffness. One acromial stress fracture occurred in the 30° humeral retroversion group. Scapular notching was observed in 7 (21.2%) of the patients in neutral version group and 5 (15.2%) of the patients in the 30° retroversion group (p = 0.750). Securing the humeral component at neutral version or 30° of retroversion in rTSA resulted in similar active shoulder external rotation, internal rotation, forward elevation, abduction, and strength measurements, complication rates, and VAS pain, PROMIS-10 physical, and ASES scores at 2 years postoperatively. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Evaluating the psychometric properties of the simplified Chinese version of PROMIS-29 version 2.1 in patients with hematologic malignancies

The Patient-Reported Outcomes Measurement Information System 29-item Profile version 2.1 (PROMIS-29 V2.1) is a widely utilized self-reported instrument for assessing health outcomes from the patients’ perspectives. This study aimed to evaluate the psychometric properties of the PROMIS-29 V2.1 Chinese version among patients with hematological malignancy. Conducted as a cross-sectional, this research was approved by the Medical Ethical Committee of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (registration number QTJC2022002-EC-1). We employed convenience sampling to enroll eligible patients with hematological malignancy from four tertiary hospitals in Tianjin, Shandong, Jiangsu, and Anhui province in China between June and August 2023. Participants were asked to complete a socio-demographic information questionnaire, the PROMIS-29 V2.1, and the Functional Assessment of Cancer Therapy-General (FACT-G). We assessed the reliability, ceiling and floor effects, structural, convergent discriminant and criterion validity of the PROMIS-29 V2.1. A total of 354 patients with a mean age of 46.93 years was included in the final analysis. The reliability of the PROMIS-29 V2.1 was affirmed, with Cronbach’s α for the domains ranging from 0.787 to 0.968. Except sleep disturbance, the other six domains had ceiling effects, which were seen on physical function (26.0%), anxiety (37.0%), depression (40.4%), fatigue (18.4%), social roles (18.9%) and pain interference (43.2%), respectively. Criterion validity was supported by significant correlations between the PROMIS-29 V2.1 and FACT-G scores, as determined by the Spearman correlation test (P < 0.001). Confirmatory factor analysis (CFA) indicated a good model fit, with indices of χ2/df (2.602), IFI (0.960), and RMSEA (0.067). The Average Variance Extracted (AVE) values for the seven dimensions of PROMIS-29 V2.1, ranging from 0.500 to 0.910, demonstrated satisfactory convergent validity. Discriminant validity was confirmed by ideal √AVE values. The Chinese version of the PROMIS-29 V2.1 profile has been validated as an effective instrument for assessing symptoms and functions in patients with hematological malignancy, underscoring its reliability and applicability in this specific patient group.

Support for a Single Underlying Dimension of Self-Reported Health in a Sample of Adults with Low Back Pain in the United States

AbstractThere is increasing interest in measuring “whole person” health and deriving an overall summary score. Underlying physical and mental health dimensions have been found consistently in prior studies of self-reported health, but it is unclear whether a single underlying health factor is supported across health domains. We examine the dimensionality of nine domains from the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 + 2 profile measure, the PROMIS social isolation scale, the Personal Wellbeing Index, and the EQ-5D-5L preference score in a sample of 1256 adults with back pain in the United States: mean age was 55 (range 18–94), 52% female, 74% non-Hispanic White, 61% were married or living with a spouse, and the highest level of education completed for 35% of the sample was a high school degree or general education diploma. The sample reported substantially more pain intensity, pain interference, and worse physical function than the U.S. general population. Product-moment correlations among the measures ranged from 0.25 to 0.83 (median correlation = 0.52). A bifactor model showed that a general health factor accounted for most of the covariation among measures, but physical function, pain interference, and pain intensity loaded slightly more on the physical health group factor than on the general health factor. The study provides some support for combining multiple aspects of self-reported health into an overall indicator of whole-person health.

Preliminary effectiveness and production time and costs of three-dimensional printed orthoses in chronic hand conditions: an interventional feasibility study.

To assess the preliminary effectiveness of three-dimensional printed orthoses compared with conventionally custom-fabricated orthoses in persons with chronic hand conditions on performance of daily activities, hand function, quality of life, satisfaction, and production time and costs. Interventional feasibility study. Chronic hand orthotic users (n = 21). Participants received a new three-dimensional printed orthosis according to the same type as their current orthosis, which served as the control condition. Primary outcome was performance of daily activities (Patient-Reported Outcomes Measurement Information System-Upper Extremity; Michigan Hand Questionnaire). Secondary outcomes were hand function, quality of life, and satisfaction. Furthermore, production time and costs were recorded. At 4 months' follow-up, no significant differences were found between three-dimensional printed orthoses and participants' existing conventional orthoses on activity performance, hand function, and quality of life. Satisfaction with the three-dimensional printed orthosis was significantly higher and the production time and costs for three-dimensional printed orthoses were significantly lower compared with conventional orthoses. The three-dimensional printed orthosis was preferred by 79% of the participants. This feasibility study in chronic hand conditions suggests that three-dimensional printed orthoses are similar to conventional orthoses in terms of activity performance, hand function, and quality of life. Satisfaction, and production time and costs favoured the three-dimensional printed hand orthoses.

Validation of Patient-Reported Outcome Measurement Information System (PROMIS) for Detection of Posttraumatic Stress in Children and Adolescents Following Procedures for Acute Orthopaedic Trauma

OBJECTIVES: The efficiency and validity of PROMIS surveys were determined for pediatric orthopaedic trauma patients with posttraumatic stress disorder (PTSD) symptoms in a clinic setting. METHODS: Design: Prospective cohort study. Setting: Single-institution, Level I Trauma Center. Patient Selection Criteria: All consecutive children aged 8-18 years undergoing procedures or surgery for orthopaedic trauma. Outcome Measures and Comparisons: The convergent, divergent, and discriminant validity of the PROMIS Anger and Anxiety computerized adaptive tests (CATs) were evaluated and compared to the previously validated Child PTSD Symptom Scale (CPSS). The efficiency in time to completion of the outcome measures was compared between the CPSS and PROMIS surveys. Cutoffs for increased likelihood of PTSD were established for the PROMIS questionnaires. RESULTS: A total of 233 subjects were included in this study (mean age 13.1 years with SD 2.8 years, 71% male). The majority (51%) of injuries were sports-related and most (60%) involved the upper extremity. Of those included, 41 patients had high levels of PTSD symptoms on the CPSS (18%; 95% CI=13.1-23.2%). The CPSS took 182 (IQR 141-228) seconds versus 52 (IQR 36-84) and 52 (IQR 36-70) seconds for PROMIS Anger and Anxiety CATs, respectively. Convergent validity showed patient scores on both PROMIS instruments significantly correlated with CPSS scores (Anger: p&lt;0.001, r=0.51; Anxiety: p&lt;0.001, r=0.41). Neither PROMIS score correlated with UCLA Activity Score (Anger: r=-0.26; Anxiety: r=-0.22), a functional outcome measure, demonstrating divergent validity. Both PROMIS instruments sufficiently discriminated across PTSD risk groups (Anger p&lt;0.001; Anxiety p&lt;0.001). A score of at least 53 on PROMIS Anger or at least 48 on PROMIS Anxiety indicated an increased likelihood of PTSD risk. CONCLUSIONS: PROMIS Anger and Anxiety CATs are efficient and valid for evaluating posttraumatic stress in children following orthopaedic trauma procedures. LEVEL OF EVIDENCE: Diagnostic Level I. See Instructions for Authors for a complete description of levels of evidence.

Assessment of the Impact of RNase in Patients With Severe Fatigue Related to Post-Acute Sequelae of SARS-CoV-2 Infection (PASC): A Randomized Phase 2 Trial of RSLV-132.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA and RNA debris persist in viral reservoirs for weeks to months following infection, potentially triggering interferon production and chronic inflammation. RSLV-132 is a biologic drug composed of catalytically active human RNase1 fused to human IgG1 Fc and is designed to remain in circulation and digest extracellular RNA. We hypothesized that removal of SARS-CoV-2 viral RNA from latent reservoirs may improve inflammation, neuroinflammation, and fatigue associated with post-acute sequelae of SARS-CoV-2 infection (PASC). This was a phase 2, double-blind, placebo-controlled randomized clinical trial in participants with a 24-week history of PASC and severe fatigue. The primary endpoint of the trial assessed the impact of 6 intravenous doses of RSLV-132 on the mean change from baseline at day 71 in the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a). A statistically significant difference on day 71 was not observed with respect to the primary or secondary endpoints. This was likely due to a placebo response that increased during the trial. Statistically significant improvement in fatigue as measured by the PROMIS Fatigue SF 7a, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and Physicians Global Assessment (PGA) instruments were observed earlier in the trial, with women demonstrating greater responses to RSLV-132 than men. While fatigue was not statistically significantly improved at Day 71, earlier timepoints revealed statistically significant improvement in fatigue and physician global assessment. The data suggest eliminating latent viral RNA by increasing serum RNase activity may improve fatigue in PASC patients. Women may respond better to this approach than men. Future studies will aim to confirm these findings.

Improvement in quality of life after Asfotase Alfa treatment in adults with Pediatric-onset Hypophosphatasia: data from 5 patient-reported outcome measures

Abstract Hypophosphatasia (HPP) is a rare inherited metabolic disorder caused by deficient tissue-nonspecific alkaline phosphatase activity. This study assessed the impact of treatment with asfotase alfa on patient-reported outcomes (PROs) in adults with pediatric-onset HPP. A longitudinal telephone-based survey was administered to eligible individuals enrolled in a patient support program. Interviews were conducted at study entry (prior to asfotase alfa initiation) and after 3, 6, and 12 months. PROs—Patient Health Questionnaire-9 [PHQ-9], Work Productivity and Activity Impairment–Specific Health Problem [WPAI:SHP], Patient-Reported Outcomes Measurement Information System 29 [PROMIS-29], and Routine Assessment of Patient Index Data 3 [RAPID3]—were assessed at each time point. Appropriate statistical tests were performed to assess score changes. Among 50 enrolled patients (mean age: 46 years [SD: 15.4]; 80% female; 94% white), 49 were evaluable at 3 months, 44 at 6 months, and 29 at 12 months. By Month 3, statistically significant improvements from baseline were detected in PHQ-9 scores (10.6 vs. 5.8 [p &amp;lt; 0.0001]), PROMIS-29 domain scores (overall physical function: 38.0 vs. 43.0 [p = 0.001]; anxiety: 57.5 vs. 51.5 [p = 0.0011]; fatigue: 63.3 vs. 55.3 [p &amp;lt; 0.0001]; sleep disturbances: 58.8 vs. 54.3 [p = 0.0099]; ability to participate in social roles and activities: 42.6 vs. 47.7 [p = 0.0012]; and pain interference: 63.8 vs. 58.4 [p = 0.001]) and RAPID3 domain scores (functional status: 2.7 vs. 1.1 [p &amp;lt; 0.0001]; pain tolerance: 6.0 vs. 3.2 [p &amp;lt; 0.0001]; and global health estimate: 5.1 vs. 2.7 [p &amp;lt; 0.0001]). Improvements persisted at Month 12. Patients also showed improvements in WPAI:SHP domain scores at Month 6 (presenteeism: 39.6% vs. 14.1% [p &amp;lt; 0.0001] and work productivity loss: 41.9% vs. 14.1% [p &amp;lt; 0.0001]). Treatment with asfotase alfa was associated with improved quality of life across several domains.

Patterns of Social Needs Predict Quality-of-Life and Healthcare Utilization Outcomes in Patients from a Large Hospital System.

Unmet social needs (SNs) often coexist in distinct patterns within specific population subgroups, yet these patterns are understudied. To identify patterns of social needs (PSNs) and characterize their associations with health-related quality-of-life (HRQoL) and healthcare utilization (HCU). Observational study using data on SNs screening, HRQoL (i.e., low mental and physical health), and 90-day HCU (i.e., emergency visits and hospital admission). Among patients with any SNs, latent class analysis was conducted to identify unique PSNs. For all patients and by race and age subgroups, compared with no SNs, we calculated the risks of poor HRQoL and time to first HCU following SNs screening for each PSN. Adult patients undergoing SNs screening at the Mass General Brigham healthcare system in Massachusetts, United States, between March 2018 and January 2023. SNs included: education, employment, family care, food, housing, medication, transportation, and ability to pay for household utilities. HRQoL was assessed using the Patient-Reported Outcomes Measurement Information System Global-10. Six unique PSNs were identified: "high number of social needs," "food and utility access," "employment needs," "interested in education," "housing instability," and "transportation barriers." In 14,230 patients with HRQoL data, PSNs increased the risks of poor mental health, with risk ratios ranging from 1.07(95%CI:1.01-1.13) to 1.80(95%CI:1.74-1.86). Analysis of poor physical health yielded similar findings, except that the "interested in education" showed a mild protective effect (0.97[95%CI:0.94-1.00]). In 105,110 patients, PSNs increased the risk of 90-day HCU, with hazard ratios ranging from 1.09(95%CI:0.99-1.21) to 1.70(95%CI:1.52-1.90). Findings were generally consistent in subgroup analyses by race and age. Certain SNs coexist in distinct patterns and result in poorer HRQoL and more HCU. Understanding PSNs allows policymakers, public health practitioners, and social workers to identify at-risk patients and implement integrated, system-wide, and community-based interventions.