UNASSIGNED: The overall aim of this study was to assess the effectiveness of endoscopic decompression for outcomes in patients with lumbar spinal stenosis (LSS).
UNASSIGNED: We conducted a retrospective cohort, single-institution study of n = 139 patients from 2019 to 2022 who underwent endoscopic decompression for LSS. The primary outcome was improvement of Oswestry Disability Index (ODI) between baseline and 12-month follow-up.
UNASSIGNED: In the present sample (n = 139) the average age was 57.6 years (SD = 17.4, with even distribution of men (49%) vs. women (51%). In patients with LSS, lumbar disc herniation was the most common diagnosis in 49 patients followed by lumbar radiculopathy in 25 patients. Lumbar radicular pain was the 3rd most common diagnosis in 21 patients with all other diagnosis listed in Table S1. There was a significant improvement (i.e., decrease) in ODI following endoscopic decompression (mean change: -8.3, 95% CI: -9.4, -7.2, P < 0.001, Fig. 1). Prior lumbar spine surgery (P = 0.048), BMI (P = 0.053), and age (P = 0.022) were associated with changes in ODI. Nearly half (47%) of the sample had prior lumbar spine surgery. Those with prior lumbar spine surgery (-7.5, 95% CI: -8.3, -6.6) showed less improvement than those without prior lumbar spine surgery (-9.1, 95% CI: -10.9, -7.2, Fig. 2). For BMI, 23% had normal BMI while 24% were overweight and 53% were obese. Patients with normal BMI (-10.3, 95% CI: -13.4, -7.2) showed greater improvements compared to overweight (-7.9, 95% CI: -9.4, -6.4) and obese (-7.6, 95% CI: -9.0, -6.3, Fig. 3) patients. Patients under 40 years old (-10.2, 95% CI: -13.6, -6.8) showed greater improvements in ODI compared to those 40 years and older (-7.8, 95% CI: -8.6, -6.8, Fig. 4).
UNASSIGNED: In patients with lumbar spinal stenosis, endoscopic decompression was associated with reduced disability. Patients with no prior lumbar spine surgery, normal BMI, and who were under 40 years old showed greater improvements.

Background  Patient-reported outcome measures (PROMs) have gained traction in assessing patients\' health around surgery. Among these, the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a widely accepted tool for evaluating overall health, yet its applicability in cranial neurosurgery remains uncertain. Objective  This study aimed to evaluate the predictive value of preoperative PROMIS-29 scores for postoperative outcomes in patients undergoing brain tumor resection. Materials and Methods  We identified adult patients undergoing brain tumor resection at a single neurosurgical center between January 2018 and December 2021. We analyzed physical health (PH) summary scores to determine optimal thresholds for predicting length of stay (LOS), discharge disposition (DD), and 30-day readmission. Bivariate analyses were conducted to examine the distribution of PH scores based on patient characteristics. Multivariate logistic regression models were employed to assess the association between preoperative PH scores and short-term postoperative outcomes. Results  Among 157 patients (mean age 55.4 years, 58.0% female), 14.6% exhibited low PH summary scores. Additionally, 5.7% experienced prolonged LOS, 37.6% had nonroutine DDs, and 19.1% were readmitted within 30 days. Bivariate analyses indicated that patients with low PH summary scores, indicating poorer baseline PH, were more likely to have malignant tumors, nonelective admissions, and adverse outcomes. In multivariate analysis, low PH summary scores independently predicted increased odds of prolonged LOS (odds ratio [OR] = 6.09, p  = 0.003), nonroutine DD (OR = 4.25, p  = 0.020), and 30-day readmission (OR = 3.93, p  = 0.020). Conclusion  The PROMIS-29 PH summary score serves as a valuable predictor of short-term postoperative outcomes in brain tumor patients. Integrating this score into clinical practice can enhance the ability to anticipate meaningful postoperative results.

BACKGROUND: Health-related quality of life (HRQL) has become an important outcome parameter in cardiology. The MOS 36-ltem Short-Form Health Survey (SF-36) and the PROMIS-29 are two widely used generic measures providing composite HRQL scores. The domains of the SF-36, a well-established instrument utilized for several decades, can be aggregated to physical (PCS) and mental (MCS) component summary scores. Alternative scoring algorithms for correlated component scores (PCSc and MCSc) have also been suggested. The PROMIS-29 is a newer but increasingly used HRQL measure. Analogous to the SF-36, physical and mental health summary scores can be derived from PROMIS-29 domain scores, based on a correlated factor solution. So far, scores from the PROMIS-29 are not directly comparable to SF-36 results, complicating the aggregation of research findings. Thus, our aim was to provide algorithms to convert PROMIS-29 data to well-established SF-36 component summary scores.
METHODS: Data from n = 662 participants of the Berlin Long-term Observation of Vascular Events (BeLOVE) study were used to estimate linear regression models with either PROMIS-29 domain scores or aggregated PROMIS-29 physical/mental health summary scores as predictors and SF-36 physical/mental component summary scores as outcomes. Data from a subsequent assessment point (n = 259) were used to evaluate the agreement between empirical and predicted SF-36 scores.
RESULTS: PROMIS-29 domain scores as well as PROMIS-29 health summary scores showed high predictive value for PCS, PCSc, and MCSc (R2 ≥ 70%), and moderate predictive value for MCS (R2 = 57% and R2 = 40%, respectively). After applying the regression coefficients to new data, empirical and predicted SF-36 component summary scores were highly correlated (r > 0.8) for most models. Mean differences between empirical and predicted scores were negligible (|SMD|<0.1).
CONCLUSIONS: This study provides easy-to-apply algorithms to convert PROMIS-29 data to well-established SF-36 physical and mental component summary scores in a cardiovascular population. Applied to new data, the agreement between empirical and predicted SF-36 scores was high. However, for SF-36 mental component summary scores, considerably better predictions were found under the correlated (MCSc) than under the original factor model (MCS). Additionally, as a pertinent byproduct, our study confirmed construct validity of the relatively new PROMIS-29 health summary scores in cardiology patients.

OBJECTIVE: This study evaluates the interpretability of Patient-Reported Outcomes Measurement Information System® (PROMIS®)-16 profile domain scores (physical function, ability to participate in social roles and activities, anxiety, depression, sleep disturbance, pain interference, cognitive function - abilities, and fatigue) compared to the PROMIS-29 scores and a 5-item PROMIS cognitive function score. The study aims to provide insights into using these measures in clinical and research settings.
METHODS: Analyses were conducted using data from 4130 adults from a nationally representative, probability-based internet panel between September and October 2022. A subset of 1256 individuals with back pain was followed up at six months. We compared the PROMIS-16 profile with the corresponding domain scores from the PROMIS-29 and a custom five-item cognitive function measure. We evaluated (1) reliability through inter-item correlations within each domain and (2) criterion validity by comparing PROMIS-16 profile with the corresponding longer PROMIS measures: (a) standardized mean differences in domain scores, (b) correlations, and (c) concordance of change (i.e., got worse, stayed the same, got better) among those with back pain from baseline to six months later using the reliable change index. We report the Kappa coefficient of agreement and the frequency and percentage of participants with concordant classifications.
RESULTS: Inter-item correlations for the PROMIS-16 domains ranged from 0.65 in cognitive function to 0.92 in pain interference. Standardized mean differences between PROMIS-16 and the scores for the corresponding longer PROMIS domains were minimal (< 0.2). Correlations among the corresponding domain scores ranged from 0.82 for sleep disturbance to 0.98 for pain interference. The percentage of concordance in change groups ranged from 63% for sleep disturbance to 88% for pain interference. Except for sleep disturbance, the change groups derived from the PROMIS-16 showed moderate to substantial agreement with scores estimated from the longer PROMIS measures (Kappa coefficients ≥ 0.41).
CONCLUSIONS: The PROMIS-16 domain scores perform similarly to the longer PROMIS measures and can be interpreted in the same way. This similarity indicates that PROMIS-16 can be useful for research as a brief health-related quality-of-life profile measure.
The Patient-Reported Outcomes Measurement Information System® (PROMIS®)-16 Profile assesses eight health-related quality of life domains (physical function, ability to participate in social roles and activities, anxiety, depression, sleep disturbance, pain interference, cognitive function – abilities, and fatigue) using two items per domain. We evaluated the PROMIS-16 profile in a sample drawn from a nationally representative, probability-based internet panel. The study supports the reliability and criterion validity of the PROMIS-16, showing that the domain scores closely align with and have high concordance in change with the PROMIS-29 scores and a custom five-item cognitive function score. The PROMIS-16 has the potential to be a brief health-related quality-of-life profile measure in research and clinical settings.

OBJECTIVE: To evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials.
METHODS: Content validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn\'s disease (Crohn\'s disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn\'s disease (N = 360) and UC (N = 518).
RESULTS: Common (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (rs ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain.
CONCLUSIONS: PROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials.

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.

BACKGROUND: Individuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID.
METHODS: The PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir. Participants are recruited via patient groups, cultural ambassadors, and social media platforms. Medical records are reviewed through a platform facilitating participant-mediated data acquisition from electronic health records nationwide. During the drug treatment, participants complete daily digital diaries using a web-based application. Blood draws for eligibility and safety assessments are conducted at or near participants\' homes. The study drug is shipped directly to participants\' homes. The primary endpoint is the PROMIS-29 Physical Health Summary Score difference between baseline and Day 28, evaluated by a mixed model repeated measure analysis. Secondary endpoints include PROMIS-29 (Mental Health Summary Score and all items), Modified GSQ-30 with supplemental symptoms questionnaire, COVID Core Outcome Measures for Recovery, EQ-5D-5L (Utility Score and all items), PGIS 1 and 2, PGIC 1 and 2, and healthcare utilization. The trial incorporates immunophenotyping to identify long COVID biomarkers and treatment responders.
CONCLUSIONS: The PAX LC trial uses a novel decentralized design and a participant-centric approach to test a 15-day regimen of nirmatrelvir/ritonavir for long COVID.

OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.

Adult spinal deformity (ASD) significantly impacts the quality of life due to three-dimensional spinal abnormalities. Patient-reported outcome measures, such as the Patient-Reported Outcomes Measurement Information System (PROMIS-29), play a crucial role in assessing postoperative outcomes. This study aims to investigate trends in PROMIS-29 scores over 36 months in patients undergoing long-segment thoracolumbar fusion for ASD and provide insights into its long-term utility.
A retrospective study including 163 ASD patients undergoing long-segment thoracolumbar fusion was conducted. PROMIS-29 scores were collected at baseline and at postoperative (0-), 3-, 6-, 12-, 18-, 24-, 30-, and 36-month follow-ups. Statistical analyses was performed to assess significant score changes from baseline and in consecutive recordings.
Significant improvements in all PROMIS-29 categories were observed at 36 months, with the greatest changes in pain intensity (-35.19%, P < 0.001), physical function (+29.13%, P < 0.001), and pain interference (-28.8%, P < 0.001). Between the 0 and 3 month mark, the greatest significant changes were recorded in pain intensity (-26.5%, P < 0.001), physical function (+24.3%, P < 0.001), and anxiety (-16.9%, P < 0.018). However, scores plateaued after the 3-month mark, with zero categories showing significant changes with subsequent consecutive recordings.
PROMIS-29 scores demonstrated notable improvements in ASD patients particularly in pain intensity, pain interference, and physical function. However, scores plateaued beyond the 3-month mark, suggesting PROMIS-29\'s limited sensitivity to nuanced changes in long-term patient recovery. Future investigations exploring optimal combinations of patient reported outcome measures for comprehensive short- and long-term outcome assessments in ASD surgery would be beneficial.

OBJECTIVE: Lupus nephritis (LN) can occur as an isolated component of disease activity or be accompanied by diverse extrarenal manifestations. Whether isolated renal disease is sufficient to decrease health related quality of life (HRQOL) remains unknown. This study compared Patient-Reported Outcomes Measurement Information System 29-Item (PROMIS-29) scores in LN patients with isolated renal disease to those with extrarenal symptoms to evaluate the burden of LN on HRQOL and inform future LN clinical trials incorporating HRQOL outcomes.
METHODS: A total of 181 LN patients consecutively enrolled in the multicentre multi-ethnic/racial Accelerating Medicines Partnership completed PROMIS-29 questionnaires at the time of a clinically indicated renal biopsy. Raw PROMIS-29 scores were converted to standardized T scores.
RESULTS: Seventy-five (41%) patients had extrarenal disease (mean age 34, 85% female) and 106 (59%) had isolated renal (mean age 36, 82% female). Rash (45%), arthritis (40%) and alopecia (40%) were the most common extrarenal manifestations. Compared with isolated renal, patients with extrarenal disease reported significantly worse pain interference, ability to participate in social roles, physical function, and fatigue. Patients with extrarenal disease had PROMIS-29 scores that significantly differed from the general population by > 0.5 SD of the reference mean in pain interference, physical function, and fatigue. Arthritis was most strongly associated with worse scores in these three domains.
CONCLUSIONS: Most patients had isolated renal disease and extrarenal manifestations associated with worse HRQOL. These data highlight the importance of comprehensive disease management strategies that address both renal and extrarenal manifestations to improve overall patient outcomes.