Patient-Reported Outcomes Measurement Information System Research Articles

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 < 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 < 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 < 0.0001]; pain tolerance: 6.0 vs. 3.2 [p < 0.0001]; and global health estimate: 5.1 vs. 2.7 [p < 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 < 0.0001] and work productivity loss: 41.9% vs. 14.1% [p < 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.

Abstract PO5-11-07: Short- and long-term treatment-related effects on physical health in breast cancer survivors

Abstract Background. Breast cancer (BC) survivors experience greater physical health declines compared to cancer-free women of the same age, which is thought to be caused by their cancer and its treatment. However, the short- and long-term effects of different types of treatment on physical health are not well understood, especially for hormone therapy. Moreover, whether specific aspects of physical health, such as activities of daily living (ADL), are affected by treatment is unknown. Methods. This analysis was conducted in the Cancer Prevention Study 3 (CPS-3), a prospective cohort study with approximately 300,000 participants enrolled between 2006-2013. Participants returned a baseline survey and triennial follow-up surveys beginning in 2015. Incident, non-metastatic, female BC patients were included in this analysis if they returned a survey at least 90 days after their diagnosis through June 30, 2020, the end of follow-up for this analysis. All 2,551 BC patients included in this study had pre- and post-diagnostic surveys and underwent breast surgery if they were diagnosed with invasive disease. They were matched to up to five cancer-free women on age and year of survey returns (N=12,704). Self-reported physical health and ADL were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale instrument. Treatment information was obtained from cancer registries and self-report and included surgery, chemotherapy, radiation and hormonal therapy. Odds Ratios (OR) and 95% confidence intervals (CI) between treatment received and self-reported physical function were estimated using multivariable ordinal logistic regression models at three time points relative to the case’s diagnosis date: before diagnosis, within 90 days to 5 years after diagnosis, and more than 5 years after diagnosis. Results. Median age at diagnosis was 56 years (interquartile range (IQR): 50-62). Approximately 82% of the tumors were hormone-receptor positive. The median times from the three physical health measurements to diagnoses were 1.7 years before diagnosis (IQR: 0.9 – 2.7), 1.7 years (IQR: 0.9 – 2.5) from 90 days to 5 years post-diagnosis and 6.6 years (IQR: 5.5-7.0) for more than 5 years post-diagnosis. There was a significant risk of physical decline within 5 years of diagnosis for women who received chemotherapy or hormonal therapy compared to cancer-free women (Table 1). However, more than 5 years after diagnosis, the risk of physical decline was only observed among those who received chemotherapy. Treatment combinations that included chemotherapy were also associated with a decline in the ability to carry out ADL during the first 5 years. Patients who received hormonal therapy without chemotherapy were comparable to cancer-free women in their ability to carry out ADL during the post-diagnosis period. BC patients who received surgery only or surgery and radiation reported physical health and ADLs similar to cancer-free women within 5 and >5 years after diagnosis. Conclusions. Post-diagnosis physical health decline is time and treatment dependent. Patients receiving chemotherapy have the greatest overall physical health decline and it is long-lasting. Beyond five years from diagnosis, physical health of breast cancer patients who did not receive chemotherapy were similar to cancer-free women. Strategies are needed to help BC patients receiving chemotherapy overcome the long-term physical function limitations of their cancer treatment. Table. Associations between treatment received and physical health and ability to carry out activities of daily living. OR: Odds Ratio; CI: confidence interval; chemo: chemotherapy; radio: radiation therapy; horm: hormonal therapy. *Associations were adjusted for matching factors, which included age and time from diagnosis to measurement of physical health. Citation Format: Clara Bodelon, Matthew Masters, Lauren McCullough, Alpa Patel, Lauren Teras. Short- and long-term treatment-related effects on physical health in breast cancer survivors [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-11-07.

Impact of Coronavirus disease 2019 pandemic in children with functional abdominal pain disorders: Data from long-term follow-up.

We aimed to compare symptom frequency and severity in children with functional abdominal pain disorders (FAPDs) and to evaluate anxiety, quality of life (QoL) and global health during Coronavirus disease 2019 (COVID-19) related quarantine and after 17 months. Children diagnosed with FAPDs between October 2019 and February 2020 at 5 different centers were enrolled and prospectively interviewed during the COVID-19 quarantine and 17 months later when schools, hospital services, and routine activities had re-opened to the public. The patients were asked to complete the Rome IV questionnaire, the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scale, the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and global health questionnaires. Data about COVID-19 infection and its clinical outcome were also collected. Ninety-nine out of 180 (55%) children completed the follow-up. The number of patients reporting a worsening of their symptoms was significantly higher at follow-up when compared to the quarantine period (24/99 [24.2%] vs. 12/99 [12.1%]; p = 0.04). The PedsQL 4.0 subtotal score at follow-up significantly decreased at 17 months of follow-up (65.57 [0-100]) when compared to the quarantine (71 [0-100], p = 0.03). Emotional functioning was the most significantly reduced (Follow-up: 64.7 [0-100] vs. Quarantine: 75 [0-100]; p = 0.006). We did not identify significant differences in symptoms and QoL between COVID-19 infected children and the remaining cohort at the two time points. An improvement of symptoms and QoL was observed during the quarantine, followed by a worsening at-follow-up. These findings reinforce the hypothesis that the nest effect overweighted COVID-19 fears during the quarantine and highlight the importance of psychological factors in symptom exacerbation.

Abstract PO2-10-09: Professional Support for Eating and Nutrition among Women Living with Breast Cancer: Implications for Mental Health and Quality of Life

Abstract Background: Within oncology, nutrition and eating behaviors are often tied to cancer prevention, incidence rates, progression, and healthy survivorship, as well as symptom and side effect management. While many nutrition-related resources and guidelines focus on physical health outcomes, support around nutrition and eating behaviors can have critical implications for mental health and quality of life outcomes among breast cancer patients and survivors. Methods: 232 women with breast cancer enrolled in the online Cancer Experience Registry and provided sociodemographic and clinical characteristics, answered questions about their eating and nutrition experiences, including utilization of a Registered Dietitian for professional eating and nutrition support since being diagnosed with cancer, and completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29v2.0 + 2-item Cognitive Function Short Form). Frequencies were calculated and group differences among those who wanted professional support for eating and nutrition but either did or did not receive it were assessed using independent-samples t-tests. Results: The sample was 81% Non-Hispanic (NH) White, 9% NH Black. Participants varied in age (mean=61 yrs; SD=9.2), time since diagnosis (median=7 yrs, range: < 1-39) and socioeconomic status (16% household income < $40K; 32% employer-provided insurance coverage). 44% were currently receiving treatment, with 70% in remission, 12% with metastatic disease, and 21% with history of recurrence. Over one-third (36%) received professional support for eating and nutrition from a Registered Dietitian since being diagnosed with cancer, including 12% receiving that support in the last 6 months. Participants wanted professional support for eating and nutrition during active treatment (51%), after treatment (44%), at initial diagnosis (23%), before treatment (18%), before being diagnosed with cancer (11%) . The most commonly reported eating and nutrition needs driving the desire for professional support included weight-related support (54%; maintenance, gain, or loss), achieving healthy eating patterns (52%), increasing energy level (46%) and physical fitness/strength (45%). However, experiences with professional support for eating and nutrition varied: 54% wanted eating and nutrition support since being diagnosed with cancer, but only 68% of those who wanted this support were able to access care. Irrespective of access to professional eating and nutrition support, participants report changing their eating patterns to manage SSEs (50%) or improve long-term health (57%). Among those who desired professional support for eating and nutrition since being diagnosed with cancer (n=102), those who did not get the desired support (n=34) compared to those who did (n=68) reported higher levels of anxiety, depression, sleep disturbance, and pain, as well as lower levels of physical and cognitive function (all ps < .05). Levels of fatigue and social function were not significantly different between groups. Conclusion: While there is a strong desire for professional support surrounding eating and nutrition among women with breast cancer, when that support is needed and what it aims to address varies greatly. Among those interested in receiving professional support for eating and nutrition, those who accessed professional support reported greater mental health and quality of life. Further research is needed to understand barriers to accessing eating and nutrition support among those who are not able to obtain it. Community-based advocacy organizations that offer access to professional support services for eating and nutrition are critical for addressing unmet needs in this area to improve health and well-being among women with breast cancer. Citation Format: Victoria Morris, Melissa Miller, Susan Weldon, Gail Kelly. Professional Support for Eating and Nutrition among Women Living with Breast Cancer: Implications for Mental Health and Quality of Life [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-10-09.

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Multiligament Knee Reconstruction With Suture Tape Augmentation: Patient-Reported Outcomes at Minimum 2-Year Follow-up.

Multiligament knee injury (MLKI) is a severe subclass of orthopedic injury and can result in significant functional impairment. Novel MLKI graft constructs such as suture augmentation aim to enhance graft strength and optimize knee stability. The purpose of this study was to present patient-reported outcome measurements of a cohort at a minimum follow-up of 2 years after multiligament knee reconstruction (MLKR) with suture augmentation. A retrospective chart review was performed to identify patients who underwent MLKR with suture augmentation. Demographic and injury-specific variables were gathered preoperatively and postoperatively. Patients were contacted at a minimum of 2 years postoperatively to collect Patient-Reported Outcomes Measurement Information System, Multiligament Quality of Life, and Lysholm knee scores. Twenty-seven patients underwent MLKR with suture augmentation, with 15 being female (55.6%) and 12 being male (44.4%). The mean pain score was 49.93±9.96, the mean physical function score was 49.56±10.94, and the mean mobility score was 47.56±8.58. The mean physical impairment score was 33.96±23.69, the mean emotional impairment score was 36.55±26.60, the mean activity limitation score was 28.00±25.61, and the mean societal involvement score was 30.09±27.45. The mean Lysholm knee score for the cohort was 67.93±22.36. Patients who underwent MLKR with suture augmentation had satisfactory scores across all patient-reported outcome measurements. On the basis of these criteria, the average patient achieved an acceptable clinical outcome, demonstrating that MLKR with suture augmentation is a safe and efficacious surgical technique for the treatment of MLKI. [Orthopedics. 202x;4x(x):xx-xx.].

The relationship between patient-reported and objective measures of physical function among cancer survivors receiving rehabilitation care: A correlation analysis.

Physical function is associated with cancer-related quality of life and survival. The correlation of patient-reported and objective measures of physical function has not been quantified previously in the cancer rehabilitation medicine setting. To correlate patient-reported physical function with objective measures of physical function. The secondary aim is to correlate fatigue and social participation levels with objective measures of physical function. Retrospective. Tertiary university cancer center. A total of 226 cancer survivors referred to an outpatient cancer rehabilitation medicine clinic. Not applicable. Correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile domains with objective physical function measured by the 30-second sit-to-stand and hand grip strength. Pearson correlation analysis revealed a moderate correlation between patient-reported physical function and the 30-second sit-to-stand test (r = 0.57; p <.001), and a weak correlation of patient-reported physical function and handgrip strength (r = 0.27; p <.001). Multivariable regression modeling controlling for age, gender, and receipt of systemic therapy demonstrated a significant association between patient-reported physical function and the 30-second sit-to-stand test (estimated confidence interval 0.76 [0.60, 0.92], p < .01), in addition to patient-reported function and handgrip strength (estimated 0.22 [0.10, 0.34], p < .01). Multiple myeloma but no other cancer type was inversely associated with lower physical function. Patient-reported physical function correlated moderately with the 30-second sit-to-stand test, whereas hand grip strength demonstrated a weak correlation. The 30-second sit-to-stand test is a suitable substitute for patient-reported physical function. Further work evaluating how measures relate to each other across cancer populations is needed before recommending a standardized set of outcome measures.

Cognitive Outcomes of Children With Sagittal Craniosynostosis Treated With Either Endoscopic or Open Calvarial Vault Surgery

Several studies have reported a higher incidence of neurodevelopmental delays and cognitive deficits in patients with single-suture craniosynostosis; however, there are few studies examining the associations of repair type with cognitive outcomes. To measure differences in neuropsychological outcomes between school-age children who were treated for sagittal craniosynostosis and unaffected controls and explore differences in cognitive function among children with sagittal craniosynostosis who were previously treated with either endoscopic strip craniectomy or open calvarial vault surgery. This cohort study was performed between 2018 and 2022. Eligible participants included patients aged 5 to 17 years who had previously been seen as infants or toddlers (<3 years) at 1 of 3 surgical centers for craniosynostosis repair with either endoscopic surgery or open calvarial vault surgery. A separate cohort of unaffected controls were included for comparison. Data analysis was conducted from November 2023 to February 2024. Open calvarial vault surgery or endoscopic repair for single-suture craniosynostosis. The primary outcome was the Differential Ability Scales-II (DAS-II) General Conceptual Ability (GCA) score, an index for overall intellectual ability. Secondary outcomes included DAS-II subscale scores (Verbal Ability, Nonverbal Reasoning, Spatial Ability, Working Memory, and Processing Speed), and Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function scores. A total of 81 patients with sagittal craniosynostosis (59 male [73%]; 22 female [27%]) and 141 controls (81 male [57%]; 60 female [43%]) were included. Of the 81 participants with sagittal craniosynostosis, 46 underwent endoscopic repair and 35 underwent open repair. Median (range) age at time of follow-up assessment was 7.7 (5.0-14.8) years for children with sagittal craniosynostosis and median age at assessment was 8.5 (7.7-10.5) years for controls. After controlling for age at assessment, sex, and socioeconomic status, there was no statistically significant or clinically meaningful difference in GCA scores between children who underwent endoscopic repair (adjusted mean score, 100; 95% CI, 96-104) and open repair (adjusted mean score, 103; 95% CI, 98-108) (P > .99). We found no significant difference in PROMIS scores between repair types (median [range] for endoscopic repair 54 [31-68] vs median [range] for open repair 50 [32-63]; P = .14). When comparing the treatment groups with the unaffected controls, differences in subscale scores for GCA and working memory were observed but were within normal range. In this cohort study, there were no statistically or clinically significant differences in cognitive outcomes among school-age children by and type of surgical procedure used to repair nonsyndromic sagittal craniosynostosis. These findings suggest primary care clinicians should be educated about different options for craniosynostosis surgery to ensure early referral of these patients so that all treatment options remain viable.

Assessment of Sleep Disorders in Patients with CVID.

Inborn errors of immunity have been associated with reduced health-related quality of life and increased fatigue. Sleep disorders, which have been shown to contribute to fatigue and other health concerns, are prevalent in the general population, but there are limited studies evaluating these conditions in patients with common variable immunodeficiency (CVID). Our aim was to evaluate the prevalence of fatigue, sleep disturbances, and sleep-disordered breathing in adults with CVID. Patients completed 4 validated, self-administered questionnaires and a 1-night disposable home sleep apnea test. Our results demonstrated increased median Patient-Reported Outcomes Measurement Information System fatigue scores of 58.7 in patients with CVID in addition to clinically significant fatigue as measured by Fatigue Severity Scale score (median, 5.2) and overall poor sleep quality based on global Pittsburgh Sleep Quality Index score (median, 9.0). For CVID patients who completed the home sleep apnea test, 76.9% met criteria for sleep-disordered breathing with an Apnea-Hypopnea Index score of 5 or greater. The results of our study indicate that patients with CVID may have increased rates of undiagnosed sleep disorders that may contribute to increased fatigue and reduced health-related quality of life.

Surgical treatment of painful neuroma in amputated and non-amputated patients: does the level of neurotomy affect clinical outcomes?

To compare the outcomes of distal neurotomy (DN) versus proximal neurotomy (PN) for the surgical management of painful neuromas in amputees and non-amputees, whether used in passive or active treatment. A retrospective study was conducted on patients who underwent surgery for painful traumatic neuromas between 2019 and 2022. DN with neuroma excision was performed at the level of the injury or amputation. PN was performed using a separate proximal approach without neuroma excision. Outcomes included a Numerical Rating Scale (NRS) score and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, as well as patients' subjective assessments. A total of 33 patients were included: 17 amputees and 16 non-amputees. They totalized 43 neuromas treated by DN in 21 cases and PN in 22 cases. At the median follow-up time of 13 months, there were significant decreases in all NRS and PROMIS scores in the whole series. The decrease in limb pain scores was not significantly different between groups, except for the decrease in pain interference and patient satisfaction which were higher in the DN group. Sub-group analyses found the same significant differences in amputees. Targeted muscle reinnervation (TMR) was associated with a higher decrease in PROMIS scores. DN seemed to give better results in amputees but there were confusing factors related to associated lesions. In other situations, the non-inferiority of PN was demonstrated. PN could be of interest for treating neuromas of superficial sensory nerves, for avoiding direct revision of a well-fitted stump and in conjunction with TMR.

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

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

The PROMIS-16 reproduces the PROMIS-29 physical and mental health summary scores accurately in a probability-based internet panel.

The Patient-Reported Outcomes Measurement Information System® (PROMIS)-16 assesses the same multi-item domains but does not include the pain intensity item in the PROMIS-29. We evaluate how well physical and mental health summary scores estimated from the PROMIS-16 reproduce those estimated using the PROMIS-29. An evaluation of data collected from 4130 respondents from the KnowledgePanel. Analyses include confirmatory factor analysis to assess physical and mental health latent variables based on PROMIS-16 scores, reliability estimates for the PROMIS measures, mean differences and correlations of scores estimated by the PROMIS-16 with those estimated by the PROMIS-29, and associations between differences in corresponding PROMIS-16 and PROMIS-29 scores by sociodemographic characteristics. A two-factor (physical and mental health) model adequately fits the PROMIS-16 scores. Reliability estimates for the PROMIS-16 measures were slightly lower than for the PROMIS-29 measures. There were minimal differences between PROMIS physical and mental health summary scores estimated using the PROMIS-16 or the PROMIS-29. PROMIS-16 and PROMIS-29 score differences by sociodemographic characteristics were small. Using the PROMIS pain intensity item when scoring the PROMIS-16 produced similar estimates of physical and mental health summary scores. The PROMIS-16 provides similar estimates of the PROMIS-29 physical and mental health summary scores. The high reliability of these scores indicates they are accurate enough for use with individual patients.

Sleep and circadian biomarkers of postoperative delirium (SLEEP-POD): protocol for a prospective and observational cohort study

IntroductionSurgical patients over 70 experience postoperative delirium (POD) complications in up to 50% of procedures. Sleep/circadian disruption has emerged as a potential risk factor for POD in epidemiological studies. This...

The Impact on Families of Children With Congenital Upper Extremity Differences

To investigate the impact on caregivers of caring for a child with congenital upper extremity differences. In this cross-sectional study, caregivers of patients enrolled in the multi-institutional Congenital Upper Limb Difference (CoULD) registry were contacted. Demographic information and the Impact on Family Scale (IOFS), a validated measure of perceived caregiver strain, were collected. Patient-reported outcome measures from the CoULD registry, the Pediatric Outcomes Data Collection Instrument (PODCI), and Patient-Reported Outcomes Measurement Information System (PROMIS) were also analyzed for correlation with IOFS. Two hundred ninety-nine caregivers participated. Factors with significantly stronger impact on family included public insurance; bilateral upper extremity involvement; household income of $20,000-40,000; additional musculoskeletal diagnosis; and a single adult caregiver household. There was a significantly increased subcategory of IOFS-Finance score for distant travel to see the surgeon. Additionally, all categories of the PODCI (upper extremity, mobility, sports, pain, happiness, and global) demonstrated a negative correlation with IOFS. PROMIS upper extremity and peer relations also demonstrated an inverse relationship with IOFS, whereas PROMIS pain interference had a positive correlation with IOFS. The overall IOFS for children with CoULDs was greater than previously reported for children with brachial plexus birth injury, and less than cerebral palsy and congenital heart disease. Caregivers of children with congenital upper extremity differences report a significant impact on family life. Socioeconomic factors, such as economically disadvantaged or single-caregiver households, and clinical factors, such as bilateral upper extremity involvement, correlate with greater family impact. These findings represent opportunities to identify at-risk families and underscore the importance of caring for the whole family through a multidisciplinary approach. Prognostic II.

Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2)

Abstract Objectives The aims of the study were to further characterize the efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause using responder analysis and to investigate whether efficacy, not adjusted for placebo, resulted in clinically meaningful within-patient change. Methods This prespecified analysis used pooled data from two phase 3, randomized, double-blind, placebo-controlled studies (SKYLIGHT 1 and 2). Responders were those experiencing ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. Responder analysis was performed for patient-reported outcome (PRO) measures to evaluate participants achieving a clinically meaningful within-patient change (not placebo adjusted) at week 4 and 12 versus baseline. Single responders were based on outcomes of VMS frequency, Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b Total Score, Menopause-Specific Quality of Life (MENQoL) Total Score, and MENQoL VMS Domain Score. Double and triple responder analyses combined VMS frequency plus one or more of the PRO. Patient Global Impression of Change VMS was deemed a suitable anchor measure for meaningful within-patient change in VMS frequency. Results A greater proportion of fezolinetant-treated versus placebo-treated participants had ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. A greater proportion of responders were observed in the fezolinetant groups versus placebo at week 12 in all four single responder analyses. In the double and triple responder analyses, odds ratios were supportive of a beneficial effect for both doses of fezolinetant versus placebo. Conclusions Fezolinetant was associated with significantly higher within-patient clinically meaningful improvement in important PRO, including VMS frequency, PROMIS SD SF 8b Total Score, MENQoL Total Score, and MENQoL VMS Domain Score.

Family characteristics and childcare patterns associated with early social functioning in cancer-bereaved parents.

Bereaved parents experience life-long grief after the death of their child from cancer. Parents who can integrate their grief and maintain their social functioning early in bereavement, even in the setting of concurrent psychosocial distress, have improved outcomes. Identifying the factors associated with bereaved parents' early social functioning can guide future supportive interventions. The authors surveyed parents of children who died from cancer at two large centers 6-24 months after death, assessing bereavement experiences using validated and pilot tested tools. Univariable and multivariable logistical regression models were used to examine which family and child demographic, treatment, and end-of-life (EOL) factors were associated with maintained parental social functioning (T scores ≥40 on the Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities-Short Form questionnaire). One hundred twenty-eight parents of 88 children participated (38% household response rate); most parents identified as female (63%) and White (88%). Parents' median age was 47 years (interquartile range, 10 years); and the median time from the child's death to survey completion was 13 months (interquartile range, 10 months). In multivariate modeling, parents without household material hardship and those who felt prepared for EOL circumstances had increased odds of maintained social functioning (odds ratio, 4.7 [95% confidence interval, 1.6-13.7; p<.004] and 5.5 [95% confidence interval, 1.9-15.9; p<.002], respectively). Parents who felt prepared for their child's EOL and those without household material hardship were more likely to have maintained social functioning in the first 2 years after their child's death. Interventions targeting EOL preparedness and alleviating household material hardship may improve bereavement outcomes.

Clinical outcomes of open Latarjet-Patte procedures performed for recurrent anterior shoulder instability with primary bone loss versus failed arthroscopic Bankart repair.

The purpose of this study is to compare the outcomes of Latarjet-Patte procedures (LPs) performed for primary glenohumeral instability surgery in the setting of critical bone loss (LP-BL) versus salvage surgery performed after a failed primary arthroscopic Bankart repair (LP-FB). Patients who underwent an LP from 2017 to 2021 were identified from the senior author's database and separated into cohorts by LP indication. Data abstracted from electronic medical records included demographic information, preoperative clinical scores, radiological imaging, and complications. Postoperative clinical outcome scores collected after a 2-year minimum follow-up included: patient-reported outcomes measurement information system (PROMIS) upper extremity (UE), PROMIS Pain interference, PROMIS pain intensity, American Shoulder and Elbow Surgeons (ASES), and Visual Analog Scale pain scores. A total of 47 patients (LP-BL: n=29, LP-FB: n=18) with a mean age of 29 years (range, 15-58 years) were included in this study. Both cohorts achieved good upper extremity functionality without significant differences as indicated by mean PROMIS UE (LP-BL: 52.6±10.0 vs. LP-FB: 54.6±7.6, P=0.442) and ASES scores (LP-BL: 89.9±15.7 vs. LP-FB: 91.5±14.4, P=0.712). However, the LP-FB cohort reported lower levels of pain (LP-FB: 0.5±1.1 vs. LP-BL: 1.9±2.7, P=0.020) at their latest follow-up. There were no significant differences in complication rates including re-dislocation between cohorts (LP-BL: 2/29 [6.9%] vs. LP-FB: 2/18 [11.1%], P=0.629). When performed after failed Bankart repair, the LP results in similar postoperative functional outcomes and similar rates of complications and re-dislocations when compared to the primary indication of recurrent glenohumeral instability in the setting of critical bone loss.

Physician Empathy and Chronic Pain Outcomes

Empathy is an aspect of the patient-physician relationship that may be particularly important in patients with chronic pain. To measure the association of physician empathy with pain, function, and health-related quality of life (HRQOL) among patients with chronic low back pain. This cohort study included adult enrollees from the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation national pain research registry. Study dates were from April 1, 2016, to July 25, 2023, with up to 12 months of follow-up. Physician empathy was assessed with the Consultation and Relational Empathy measure and dichotomized to yield very empathic physician and slightly empathic physician groups. Main outcomes were patient-reported pain, function, and HRQOL measured with a numerical rating scale for low back pain intensity, the Roland-Morris Disability Questionnaire for back-related disability, and the Patient-Reported Outcomes Measurement Information System for HRQOL deficits pertaining to anxiety, depression, fatigue, sleep disturbance, and pain interference. Data were collected at 5 quarterly encounters from registry enrollment through 12 months and analyzed with generalized estimating equations, including multivariable models to measure temporal trends and to adjust for baseline and longitudinal covariates. Among the 1470 patients, the mean (SD) age was 53.1 (13.2) years, and 1093 (74.4%) were female. Patients completed 5943 encounters in which multivariable analyses demonstrated that greater physician empathy was inversely associated with pain intensity (β = -0.014; 95% CI, -0.022 to -0.006; P < .001), back-related disability (β = -0.062; 95% CI, -0.085 to -0.040; P < .001), and HRQOL deficits on each measure (eg, pain interference: β = -0.080; 95% CI, -0.111 to -0.049; P < .001). Correspondingly, compared with the slightly empathic physician group, the very empathic physician group reported lower mean pain intensity (6.3; 95% CI, 6.1-6.5 vs 6.7; 95% CI, 6.5-6.9; P < .001), less mean back-related disability (14.9; 95% CI, 14.2-15.6 vs 16.8; 95% CI, 16.0-17.6; P < .001), and fewer HRQOL deficits on each measure (eg, fatigue: 57.3; 95% CI, 56.1-58.5 vs 60.4; 95% CI, 59.0-61.7; P < .001). All physician empathy group differences were clinically relevant, with Cohen d statistics ranging from 0.21 for pain intensity to 0.30 for back-related disability, fatigue, and pain interference. Physician empathy was associated with more favorable outcomes than non-pharmacological treatments, opioid therapy, and lumbar spine surgery. In this cohort study of adult patients with chronic pain, physician empathy was associated with better outcomes over 12 months. Greater efforts to cultivate and improve physician empathy appear warranted.