Measurement Information System Item Banks Research Articles

Prospective Patient-reported Psychosocial Outcomes of Facial Feminization Surgery

PURPOSE: Gender affirming surgery is an essential component in the treatment of gender dysphoria. While health insurance plans have deemed several gender-affirming surgeries as medically necessary, facial reconstructive procedures continue to be debated due to a deficiency of high-level evidence for quality-of-life improvements. As face perception neural networks allow for immediate gender identification, facial gender-affirming surgery is frequently the first and most important surgery for many patients with gender dysphoria, particularly in the transfeminine population. In this work, we administer a battery of validated, quantitative patient-reported outcomes measures examining the psychosocial functioning of a cross-section of transgender patients who have or have not received facial feminization surgery (FFS). METHODS: In total, 96 patients (age 33.07 ± 10.60 years) receiving an FFS consultation at the University of California, Los Angeles were prospectively enrolled from 2019 to 2021 and administered 11 adult Patient-Reported Outcomes Measurement Information System item banks, including version 1.0 anxiety short form 8a, version 1.1 anger short form 5a, version 1.0 depression short form 8b, version 1.2 global health form, version 2.0 satisfaction with sex life form, version 1.0 positive affect short form 15a, version 1.0 meaning and purpose short form 4a, version 2.0 emotional support short form 4a, version 2.0 companionship short form 4a, and version 2.0 social isolation short form 4a. Descriptive statistics and linear regression analyses were performed. RESULTS: Patients who received FFS (assessed 236.35 ± 143.30 days postoperatively) demonstrated improvements in anxiety, anger, depressive symptoms, sex life, positive affect, emotional support, and meaning and purpose instrument scores. Because psychosocial functioning is likely to be influenced by multiple factors, we developed a linear regression model to understand whether FFS would be an independent predictor of psychosocial scores. Other predictors included were the presence or absence of other gender affirming surgery, binary or non-binary gender identity, duration of hormone treatment, age at the time of assessment, and global health scores as a measure of baseline health. For anxiety scores, this model accounted for 36.6% of the variance [F(6,78) = 7.512, P < 0.001], and for anger scores, this model accounted for 23.2% of the variance [F(6,78) = 3.919, P = 0.02]. The completion of FFS independently predicted lower anxiety scores (beta = −0.197, P = 0.04) and lower anger scores (beta = −0.219, P = 0.04). With the exception of global health, no other variables were significantly predictive of either anxiety or anger scores. CONCLUSIONS: Our prospective, cross-sectional assessment of psychosocial outcomes demonstrated a global improvement in psychosocial functioning in patients who have received FFS. The linear regression model that includes other potential predictors of variance in scores such as other gender affirming surgery, age, and duration of hormone therapy demonstrated that completion of FFS was an independent predictor of lower anxiety and anger scores. This work is the first Level II evidence study in quality of life of outcomes for patients who have undergone FFS and it is also the first study utilizing robust, validated instruments for assessment. Future directions of this work include longitudinal analyses of patient outcomes after FFS.

Stanford Pragmatiec Effectiveness Comparison (SPEC) protocol: Comparing long-term effectiveness of high-frequency and burst spinal cord stimulation in real-world application

ObjectivesHigh-frequency and burst stimulation are newer waveforms that have demonstrated promise compared to traditional tonic spinal cord stimulation (SCS), but more studies are needed to compare their effectiveness. We report the study methods for an ongoing, single center, pragmatic randomized clinical trial to compare the effectiveness of high-frequency and burst SCS in patients with chronic back and/or leg pain. Materials and methodsParticipants who are candidates for spinal cord stimulation are enrolled and screened. Participants will be randomly assigned using point-of-care randomization to receive either high-frequency or burst SCS. Data collection will be through Stanford Pain Management Center's learning healthcare system: CHOIR. CHOIR surveys include National Institutes of Health Patient Reported Outcomes Measurement Information System item banks, a body map, questions about pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization. Participants will complete online surveys at baseline and then 1, 3, 6, 12, 18, 24 and 36 months after their device implant. All participants will use our routine process of trial and implant. Reported adverse events are monitored throughout the study. Our primary outcome is change from baseline in pain intensity at 12 months. ResultsWe hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain. ConclusionsThe pragmatic nature of our proposed trial enables us to recruit a larger participant cohort faster and to follow up these participants longer than currently published clinical trials.

Psychometric Properties of the Pediatric Patient-Reported Outcomes Measurement Information System Item Banks in a Dutch Clinical Sample of Children With Juvenile Idiopathic Arthritis.

ObjectiveTo assess the psychometric properties of 8 pediatric Patient‐Reported Outcomes Measurement Information System (PROMIS) item banks in a clinical sample of children with juvenile idiopathic arthritis (JIA).MethodsA total of 154 Dutch children (mean ± SD age 14.4 ± 3.0 years; range 8–18 years) with JIA completed 8 pediatric version 1.0 PROMIS item banks (anger, anxiety, depressive symptoms, fatigue, pain interference, peer relationships, physical function mobility, physical function upper extremity) twice and the Pediatric Quality of Life Inventory (PedsQL) and the Childhood Health Assessment Questionnaire (C‐HAQ) once. Structural validity of the item banks was assessed by fitting a graded response model (GRM) and inspecting GRM fit (comparative fit index [CFI], Tucker‐Lewis index [TLI], and root mean square error of approximation [RMSEA]) and item fit (S‐X2 statistic). Convergent validity (with PedsQL/C‐HAQ subdomains) and discriminative validity (active/inactive disease) were assessed. Reliability of the item banks, short forms, and computerized adaptive testing (CAT) was expressed as the SE of theta (SE[θ]). Test–retest reliability was assessed using intraclass correlation coefficients (ICCs) and smallest detectable change.ResultsAll item banks had sufficient overall GRM fit (CFI >0.95, TLI >0.95, RMSEA <0.08) and no item misfit (all S‐X2 P > 0.001). High correlations (>0.70) were found between most PROMIS T scores and hypothesized PedsQL/C‐HAQ (sub)domains. Mobility, pain interference, and upper extremity item banks were able to discriminate between patients with active and inactive disease. Regarding reliability, PROMIS item banks outperformed legacy instruments. Post hoc CAT simulations outperformed short forms. Test–retest reliability was strong (ICC >0.70) for all full‐length item banks and short forms, except for the peer relationships item bank.ConclusionThe pediatric PROMIS item banks displayed sufficient psychometric properties for Dutch children with JIA. PROMIS item banks are ready for use in clinical research and practice for children with JIA.

Establishing the Factor Structure of a Health-Related Quality of Life Measurement System for Caregivers of Persons Living With Traumatic Brain Injury

ObjectivesTo understand the factor structure of health-related quality of life specific to caregivers of people living with traumatic brain injury (TBI). DesignProspective, cross-sectional data collection. SettingThree TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. ParticipantsCaregivers (N=558) of people who have sustained a TBI (344 caregivers of civilians and 214 caregivers of service members or veterans; 85% women; 58% spouses; mean age, 46.12±14.07y) who have provided care for an average of 5.82±5.40 years. InterventionsNot applicable. Main Outcomes MeasuresThe Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) measurement system including 10 Patient-Reported Outcomes Measurement Information System item banks (anger, anxiety, depression, social isolation, sleep disturbance, fatigue, ability to participate in social roles and activities, satisfaction with social roles and activities, emotional support, informational support) and 5 TBI-CareQOL banks (feelings of loss–self, feelings of loss–person with TBI, feeling trapped, caregiver-specific anxiety, caregiver strain). ResultsConfirmatory factor analysis model fit indices were compared for 14 empirically derived and 5 theoretically derived models. Confirmatory factor analysis results indicated that the best model fit was for a 6-factor model with dimensions that included mental health, social support, social participation, social isolation, physical health, and caregiver emotion. ConclusionsResults indicated that a 6-factor model provided the best model fit for health-related quality of life in caregivers of individuals with TBI. These results have utility for both research and clinical applications. Establishing the TBI-CareQOL’s factor structure provides preliminary evidence of the measurement system’s construct validity, helps inform the selection of measures for specific research or clinical interventions, and informs the development of composite scores.