Impact of preoperative back pain severity on PROMIS outcomes following minimally invasive lumbar decompression.

PURPOSE: To evaluate the effect of baseline back pain severity on PROMIS mental health outcomes following minimally invasive lumbar decompression (LD). METHODS: Patients undergoing elective, primary, single-level LD were retrospectively reviewed from a prospective single spine surgeon registry. Perioperative characteristics, demographics, and the following patient-reported outcomes (PROs) were extracted: Oswestry Disability Index (ODI)/Patient-Health Questionnaire-9 /PROMIS-Physical Function/Anxiety/Pain Interference/Sleep Disturbance (PROMIS-PF/A/PI/SD). Two cohorts were created: preoperative VAS-B < 7 and VAS-B ≥ 7. Change in PROs (ΔPROs) from baseline to six weeks/final follow-up were determined. Average patient follow-up was 13.4 ± 8.8 months. Minimal clinically important difference (MCID) achievement rates were calculated and compared through multivariable logistic regression. Postoperative scores and ΔPROs, were compared with multivariable linear regression while all other data was compared between groups with inferential statistics. RESULTS: Altogether, 347 patients were included, with 190 in the VAS-B < 7 group. VAS-B ≥ 7 reported worse outcomes preoperatively (p ≤ 0.013, all). At six weeks, VAS-B ≥ 7 reported worse VAS-B (p = 0.017), with no other significant differences. At final follow-up, patients with worse VAS-B reported worse ODI (p = 0.040) and VAS-B while all other PROs were similar (p ≥ 0.078, all). VAS-B ≥ 7 experienced greater 6-week improvements in VAS-B/ODI/PROMIS-PI/PROMIS-SD (p ≤ 0.009, all), greater VAS-B/ODI/PROMIS-SD improvement by final follow-up (p ≤ 0.009, all) and greater MCID achievement in ODI/VAS-B (p ≤ 0.027). CONCLUSION: Patients with worse baseline back pain report inferior baseline scores that converge with those with milder preoperative back pain by 6 weeks after LD and reported greater 6-week improvements in disability, pain interference, and sleep disturbance by 6 weeks, and greater improvements in disability and sleep disturbance by final follow-up.

Development of a PROMIS multidimensional cancer-related fatigue (mCRF) form using modern psychometric techniques.

PURPOSE: To develop a PRO assessment of multidimensional cancer-related fatigue based on the PROMIS fatigue assessments. METHOD: Cancer patients reporting fatigue were recruited from a comprehensive cancer care center and completed a survey including 39 items from the PROMIS Cancer Item Bank-Fatigue. Component and factor structures of the fatigue items were explored with Monte Carlo parallel factor and Mokken analyses, respectively. Psychometric properties were determined using item response theory, ensuring unidimensionality, scalability, and item independence. RESULTS: Fatigue scores from a sample of 333 fatigued cancer patients (mean age = 59.50, SD = 11.62, 67% women) were used in all scale development analyses. Psychometric analyses yielded 3 dimensions: motivational fatigue (15 items), cognitive fatigue (9 items), and physical fatigue (9 items). The subscales showed strong unidimensionality, were scalable, and were free of differential item function. Confirmatory factor analyses in a new sample of 182 patients confirmed the findings. CONCLUSION: The resulting 33-item PROMIS multidimensional cancer-related fatigue (mCRF) form provides a novel measure for the assessment of the different dimensions of cancer-related fatigue. It is the only multidimensional scale specific for cancer patients that has been developed using modern psychometric approaches. With its 3 dimensions (motivational, cognitive, and physical fatigue), this scale accurately captures the fatigue experienced by cancer patients, allowing clinicians to optimize fatigue management and improve patient care. The scale could also advance research on the nature and experience of cancer-related fatigue.

Qualitative and Psychometric Evaluation of 29-Item Patient-Reported Outcomes Measurement Information System® to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease.

OBJECTIVES: 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.

Crosswalk between the PROMIS physical function CAT and PROMIS upper extremity CAT v1.2 in a hand surgery population.

BACKGROUND: There is no gold standard patient-reported outcome measure (PROM) in hand surgery. As a result, a diverse array of PROM instruments have been utilized across centers over time. Lack of score interchangeability limits the ability to compare or conglomerate scores when new instruments are introduced. Our aim was to develop a linkage for the PROMIS UE CAT v1.2 and PROMIS PF CAT scores and develop crosswalk tables for interconversion between these PROMs. METHODS: Retrospective review was conducted to identify adult (≥ 18y) patients seen by orthopaedic hand surgeons at a single academic tertiary care hospital who had completed PROMIS UE CAT v1.2 and PROMIS PF CAT score at the same visit. For those with multiple visits, only one randomly selected visit was included in the analyses. Pearson's correlation was calculated to determine the linear relationship between the scores. Linkage from PF to UE was performed utilizing several commonly utilized equating models (identity, mean, linear, equipercentile and circle-arc methods). The performance of the models was assessed using intraclass correlation (ICC) between observed PROMIS UE CAT v1.2 and estimated PROMIS UE CAT v1.2 scores generated using the model as well as Root Mean Square Error (RMSE). The model chosen as the 'best' was further assessed for population invariance using root expected mean squared difference (REMSD) where < 0.08 were considered good. RESULTS: Of 10,081 included patients, mean age was 48.3 (SD = 17.0), and 54% were female (5,477/10,081). Mean UE CAT v1.2 and PF CAT scores were 37 (SD = 9.8) and 46 (SD = 10.0), respectively. There was a strong correlation between the scores (Pearson correlation r = 0.70). All methods performed acceptably (ICC ≥ 0.66 and RMSE < = 7.52 for all). The equipercentile method had the highest ICC (ICC = 0.70 (95% CI 0.69-0.71)) while the mean and circle arc methods had the lowest RMSE. The circle arc method is the most reliable with the smallest standard error and has satisfactory population invariance across age group (REMSD 0.065) and sex (REMSD 0.036). CONCLUSIONS: Crosswalk tables to be used for bidirectional conversion between scores were created. LEVEL OF EVIDENCE: III.

Quantifying Patient Expectations for Total Knee Arthroplasty: Expectations for Improvement Are Greater Than Minimal Clinically Important Difference.

BACKGROUND: Achieving a minimal clinically important difference (MCID) in patient-reported outcomes following total knee arthroplasty (TKA) is common, yet up to 20% patient dissatisfaction persists. Unmet expectations may explain post-TKA dissatisfaction. No prior studies have quantified patient expectations using the same patient-reported outcome metric as used for MCID to allow direct comparison. METHODS: This was a prospective study of patients undergoing TKA with 5 fellowship-trained arthroplasty surgeons at one academic center. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) domains were assessed. Expected PROMIS scores were determined by asking patients to indicate the outcomes they were expecting at 12 months postoperatively. Predicted scores were generated from a predictive model validated in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) dataset. T-tests were used to compare baseline, expected, and predicted PROMIS scores. Expected scores were compared to PROMIS MCID values obtained from the literature. Regression models were used to identify patient characteristics associated with high expectations. RESULTS: There were 93 patients included. Mean age was 67 years (range, 30 to 85) and 55% were women. Mean baseline PROMIS PF and PI was 34.4 ± 6.7 and 62.2 ± 6.4, respectively. Patients expected significant improvement for PF of 1.9 times the MCID (MCID = 11.3; mean expected improvement = 21.6, 95% confidence interval [CI] 19.6 to 23.5, P < .001) and for PI of 2.3 times the MCID (MCID = 8.9; mean expected improvement = 20.6, 95% CI 19.1-22.2, P < .001). Predicted scores were significantly lower than expected scores (mean difference = 9.5, 95% CI 7.7 to 11.3, P < .001). No unique patient characteristics were associated with high expectations (P > .05). CONCLUSIONS: To our knowledge, this study is the first to quantify preoperative patient expectations using the same metric as MCID to allow for direct comparison. Patient expectations for improvement following TKA are ∼2× greater than MCID and are significantly greater than predicted outcome scores. This discrepancy challenges currently accepted standards of success after TKA and indicates a need for improved expectation setting prior to surgery.

Mining clinical data for novel medications to treat alcohol use disorder.

BACKGROUND: Alcohol use disorder (AUD) is a highly prevalent and often debilitating condition associated with high morbidity and mortality. Current AUD medications have limited efficacy and uptake. Alternative pharmacological options are needed. METHODS: We constructed a mechanistic tree of all US Food and Drug Administration approved medications and used a tree-based scan statistic, TreeScan, to identify medications associated with greater than expected improvements in alcohol consumption. Our cohort included all United States (US) Department of Veterans Affairs (VA) patients with a diagnosis of AUD between 10/1/1999 and 9/30/2019 with multiple Alcohol Use Disorders Identification Test-Consumption Module scores within the VA electronic health record data. RESULTS: Medications statistically associated with decreased alcohol consumption had, at large, minor effect sizes. Medications used in the treatment of chronic or life-threatening conditions like diabetes, chronic kidney disease, hepatitis C virus, or cancer produced larger effect sizes. Asenapine, an atypical antipsychotic, had a large effect with an observed to expected ratio of 1.78 (p = 0.003). Our findings were replicated in a propensity score matched population. CONCLUSION: Most medications significantly associated with decreased alcohol consumption in our analysis were either contraindicated with alcohol or likely attributable to patients abstaining from alcohol due to severe illness. However, the large effect of asenapine is notable, and a worthwhile candidate for more careful analysis.

Early neurological changes in aging cervical spine: insights from PROMIS mobility assessment.

Many studies have shown that the prevalence of degenerative spinal cord compression increases with age. However, most cases at early stages are asymptomatic, and their diagnosis remains challenging. Asymptomatic cervical spinal cord compression (ASCC) patients are more likely to experience annular tears, herniated disks, and later develop symptomatic compression. Asymptomatic individuals do not typically undergo spinal cord imaging; therefore, an assessment test that is both sensitive and specific in diagnosing ASCC may be helpful. It has been demonstrated that the Patient Reported Outcome Measure Information System (PROMIS) mobility test is sensitive in detecting degenerative cervical myelopathy (DCM) symptoms. We investigated the use of the PROMIS mobility test in assessing clinical dysfunction in ASCC. In this study, 51 DCM patients and 42 age-matched healthy control (HC) were enrolled. The degree of cervical spinal cord compression was assessed using the high-resolution cervical spinal cord T2 Weighted (T2w) MRIs, which were available for 14 DCM patients. Measurements of the spinal cords anterior-posterior (AP) diameter at the region(s) that were visibly compressed as well as at different cervical spine levels were used to determine the degree of compression. The age-matched HC cohort had a similar MRI to establish the normal range for AP diameter. Twelve (12) participants in the HC cohort had MRI evidence of cervical spinal cord compression; these individuals were designated as the ASCC cohort. All participants completed the PROMIS mobility, PROMIS pain interference (PI), PROMIS upper extremity (UE), modified Japanese orthopedic association (mJOA), and neck disability index (NDI) scoring scales. We examined the correlation between the AP diameter measurements and the clinical assessment scores to determine their usefulness in the diagnosis of ASCC. Furthermore, we examine the sensitivity and specificity of PROMIS mobility test and mJOA. Compared to the HC group, the participants in the ASCC and DCM cohorts were significantly older (p = 0.006 and p < 0.0001, respectively). Age differences were not observed between ASCC and DCM (p > 0.999). Clinical scores between the ASCC and the HC group were not significantly different using the mJOA (p > 0.99), NDI (p > 0.99), PROMIS UE (p = 0.23), and PROMIS PI (p = 0.82). However, there were significant differences between the ASCC and HC in the PROMIS mobility score (p = 0.01). The spinal cord AP diameter and the PROMIS mobility score showed a significant correlation (r = 0.44, p = 0.002). Decreasing PROMIS mobility was significantly associated with a decrease in cervical spinal cord AP diameter independent of other assessment measures. PROMIS mobility score had a sensitivity of 77.3% and specificity of 79.4% compared to 59.1% and 88.2%, respectively, for mJOA in detecting cervical spinal cord compression. Certain elements of ASCC are not adequately captured with the traditional mJOA and NDI scales used in DCM evaluation. In contrast to other evaluation scales utilized in this investigation, PROMIS mobility score shows a significant association with the AP diameter of the cervical spinal cord, suggesting that it is a sensitive tool for identifying early disability associated with degenerative change in the aging spine. In a comparative analysis of PROMIS mobility test against the standard mJOA, the PROMIS mobility demonstrated higher sensitivity for detecting cervical spinal cord compression. These findings underscore the potential use of PROMIS mobility score in clinical evaluation of the aging spine.

COVID-19 Convalescent Plasma Therapy: Long-term Implications.

Background: The long-term effect of coronavirus disease 2019 (COVID-19) acute treatments on postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is unknown. The CONTAIN-Extend study explores the long-term impact of COVID-19 convalescent plasma (CCP) therapy on postacute sequelae of SARS-CoV-2 infection (PASC) symptoms and general health 18 months following hospitalization. Methods: The CONTAIN-Extend study examined 281 participants from the original CONTAIN COVID-19 trial (CONTAIN-RCT, NCT04364737) at 18 months post-hospitalization for acute COVID-19. Symptom surveys, global health assessments, and biospecimen collection were performed from November 2021 to October 2022. Multivariable logistic and linear regression estimated associations between the randomization arms and self-reported symptoms and Patient-Reported Outcomes Measurement Information System (PROMIS) scores and adjusted for covariables, including age, sex, race/ethnicity, disease severity, and CONTAIN enrollment quarter and sites. Results: There were no differences in symptoms or PROMIS scores between CCP and placebo (adjusted odds ratio [aOR] of general symptoms, 0.95; 95% CI, 0.54-1.67). However, females (aOR, 3.01; 95% CI, 1.73-5.34), those 45-64 years (aOR, 2.55; 95% CI, 1.14-6.23), and April-June 2020 enrollees (aOR, 2.39; 95% CI, 1.10-5.19) were more likely to report general symptoms and have poorer PROMIS physical health scores than their respective reference groups. Hispanic participants (difference, -3.05; 95% CI, -5.82 to -0.27) and Black participants (-4.48; 95% CI, -7.94 to -1.02) had poorer PROMIS physical health than White participants. Conclusions: CCP demonstrated no lasting effect on PASC symptoms or overall health in comparison to the placebo. This study underscores the significance of demographic factors, including sex, age, and timing of acute infection, in influencing symptom reporting 18 months after acute hypoxic COVID-19 hospitalization.

Effectiveness of Kinematic Alignment-Total Knee Arthroplasty in Treating Preoperative Varus and Valgus Deformities in Patients With Knee Osteoarthritis.

Knee osteoarthritis (OA) is surgically treated with total knee arthroplasty (TKA). Traditionally, TKA has been performed using a mechanical alignment (MA) philosophy. However, due to significant patient dissatisfaction with surgical outcomes, an alternate alignment approach, kinematic alignment (KA), has gained popularity. KA-TKAs have improved functional patient outcomes by restoring the patient's native joint line orientation and minimizing soft tissue releases compared to neutral alignment in MA-TKAs. This review explores the postoperative effectiveness of utilizing KA-TKA to treat knee OA in patients with preoperative varus and valgus deformities. A comprehensive literature search was conducted on PubMed and Biomed Central databases, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The literature search focused on studies analyzing the postoperative TKA outcomes in knee OA patients with preoperative varus or valgus deformities whose surgeries followed a KA philosophy and those comparing KA-TKA with MA-TKA. The available clinical evidence indicates that KA-TKA can be a viable treatment option for individuals with knee OA. The alignment of phenotypes has little clinical significance concerning functional outcomes and implant survival rates following KA-TKA. Furthermore, surgery outcomes in patients with preoperative deformities who underwent KA-TKA were similar to those who underwent MA-TKA. KA-TKA produced significantly better functional outcomes than MA-TKA in certain aspects. However, studies with larger sample sizes and more extended follow-up periods that directly compare KA-TKA with MA-TKA in treating knee OA patients are needed to fully demonstrate the efficacy of each technique. Furthermore, further research into the effects of KA-TKA on implant survival rates will provide a better understanding of the benefits of this technique and ultimately lead to improved patient outcomes.

The Emotion Dysregulation Inventory-Young Child: Psychometric Properties and Item Response Theory Calibration in 2- to 5-Year-Olds.

OBJECTIVE: The Emotion Dysregulation Inventory (EDI) was designed and validated to quantify emotion dysregulation (ED) in children aged 6+ years. The purpose of this study was to adapt the EDI for use in young children (EDI-YC). METHOD: Caregivers of 2,139 young children (aged 2-5 years) completed 48 candidate EDI-YC items. Factor and item response theory (IRT) analyses were conducted separately for clinical (neurodevelopmental disabilities; N = 1,369) and general population (N = 768) samples. The best-performing items across both samples were selected. Computerized adaptive testing simulations were used to develop a short-form version. Concurrent calibrations and convergent/criterion validity analyses were performed. RESULTS: The final calibrated item banks included 22 items: 15 items for Reactivity, characterized by rapidly escalating, intense, and labile negative affect, and difficulty down-regulating that affect; and 7 items for Dysphoria, characterized primarily by poor up-regulation of positive emotion, as well an item each on sadness and unease. The final items did not show differential item functioning based on age, sex, developmental status, or clinical status. IRT co-calibration of the EDI-YC Reactivity with psychometrically robust measures of anger/irritability and self-regulation demonstrated its superiority in assessing emotion dysregulation in as few as 7 items. EDI-YC validity was supported by expert review and its association with related constructs (eg, anxiety, depression, aggression, temper loss). CONCLUSION: The EDI-YC captures a broad range of emotion dysregulation severity with a high degree of precision in early childhood. It is suitable for use in all children aged 2 to 5 years, regardless of developmental concerns, and would be an ideal broadband screener for emotional/behavioral problems during well-child checks and to support early childhood irritability and emotion regulation research.

Pain Scales: What Are They and What Do They Mean.

PURPOSE OF REVIEW: It is essential to have validated and reliable pain measurement tools that cover a wide range of areas and are tailored to individual patients to ensure effective pain management. The main objective of this review is to provide comprehensive information on commonly used pain scales and questionnaires, including their usefulness, intended purpose, applicability to different patient populations, and associated advantages and disadvantages. RECENT FINDINGS: Acute pain questionnaires typically focus on measuring the severity of pain and the extent of relief achieved through interventions. Chronic pain questionnaires evaluate additional aspects such as pain-related functional limitations, psychological distress, and psychological well-being. The selection of an appropriate pain scale depends on the specific assessment objectives. Additionally, each pain scale has its strengths and limitations. Understanding the differences among these pain scales is essential for selecting the most appropriate tool tailored to individual patient needs in different settings. CONCLUSION: Medical professionals encounter challenges in accurately assessing pain. Physicians must be familiar with the different pain scales and their applicability to specific patient population.

Self-reported functioning among patients with ultra-rare nemaline myopathy or a related disorder in Finland: a pilot study.

BACKGROUND: Nemaline myopathy (NM) and related disorders (NMr) form a heterogenous group of ultra-rare (1:50,000 live births or less) congenital muscle disorders. To elucidate the self-reported physical, psychological, and social functioning in the daily lives of adult persons with congenital muscle disorders, we designed a survey using items primarily from the Patient Reported Outcomes Measurement Information System, PROMIS®, and conducted a pilot study in patients with NM and NMr in Finland. The items were linked to International Classification of Functioning, Disability and Health (ICF) categories. RESULTS: In total, 20 (62.5%) out of 32 invited persons resident in Finland participated in the study; 12 had NM and 8 NMr, 15 were women and 5 men aged 19-75 years. Sixteen (80%) were ambulatory and 4 (20%) NM patients used wheelchairs. The results from the PROMIS measuring system and ICF categories both indicated that non-ambulatory patients of this study faced more challenges in all areas of functioning than ambulatory ones, but the differences were smaller in the domains measuring psychological and social functioning than in physical functioning. In addition, the COVID-19 pandemic adversely affected the functioning of non-ambulatory patients more than that of ambulatory patients. The interindividual differences were, however, noticeable. CONCLUSIONS: To our knowledge, this pilot study is the first comprehensive survey-based study of the physical, psychological, and social functioning of adult persons with nemaline myopathy or related disorders. The results indicate vulnerability of non-ambulatory patients being at higher risk to a decrease in general functioning during global or national exceptional periods. The responses also gave directions for modifying and improving the survey for future studies.

A Qualitative Study Exploring the Regional Feasibility of Patient-Reported Outcome Measures (PROMs) Data Collection for Orthopedic Trauma Patients.

INTRODUCTION: Behavioral health has been shown to impact both short- and long-term health outcomes in trauma patients. Recommendations for screening for behavioral health concerns in the acute setting exist, but longitudinal data collection is infrequently performed. The Trauma Quality Improvement Program describes the importance of patient-reported outcome measures (PROMs), including behavioral health data. METHODS: In this qualitative feasibility study, a multidisciplinary team participated in one-hour virtual focus groups; a semi-structured interview guide was used to ascertain feedback on a proposed PROMs study design. This study utilized a qualitative methodology to reveal thematic results from the staff feedback to determine the feasibility of the proposed study design. RESULTS: Three virtual one-hour focus groups consisting of a combination of seven trauma program managers and orthopedic practice managers were asked questions related to the feasibility of a PROMs study design before thematic saturation was reached. Through the analysis, four themes emerged: barriers, possible improvements, representation and research design. Themes included subthemes as well. Noteworthy results included the impact of an integrated orthopedic practice and the technological options available for use. CONCLUSION: This study revealed the barriers that would exist in the implementation of PROMs for orthopedic trauma patients, which may be useful when designing data collection procedures for PROMs. The results related to barriers may assist other trauma centers or regional trauma systems in designing an optimal methodology for PROMs data. Furthermore, the American College of Surgeons might consider these results prior to any mandated implementation of PROMs for trauma centers to avoid any possible burden on staff and systems.

Qualitative and psychometric evaluation of the PROMIS®-Fatigue SF-7a scale to assess fatigue in patients with moderately to severely active inflammatory bowel disease.

BACKGROUND: This study evaluated the content validity and psychometric properties of the Patient-Reported Outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) v1.0 scale to determine its suitability in clinical trials to assess fatigue in patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC). METHODS: A qualitative interview assessed patients' experience living with CD (N = 20) and UC (N = 19). The contents of the SF-7a scale were cognitively debriefed to evaluate content validity. A psychometric evaluation was performed using data from clinical trials of patients with CD (N = 360) and UC (N = 214). Correlations with Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Activity Index (CDAI; CD only), and Mayo score (UC only) determined validity. The Patient Global Impression of Change (PGIC) was used to evaluate reliability and responsiveness to change. Using PGIC as an anchor, a preliminary threshold for clinically meaningful change was identified to define fatigue response in both CD and UC patients. RESULTS: All patients reported fatigue as a common symptom. Patients confirmed SF-7a items were relevant to assessing fatigue, instructions and response options were clear, and its 7-day recall period was appropriate. Higher SF-7a scores were associated with higher disease activity (CDAI and Mayo score) and lower health-related quality of life (IBDQ), confirming known groups validity. The correlation of the SF-7a scale was higher with fatigue-related items. (rs ≥ -0.70) than with items not directly associated with fatigue. Test-retest reliability was moderate to good (0.54-0.89) among patients with stable disease, and responsiveness to change in disease severity was demonstrated from baseline to Week 12. A ≥7point decrease was identified as a reasonable threshold to define clinically meaningful improvement. CONCLUSION: The SF-7a scale is a valid, reliable, and sensitive measure of fatigue in patients with moderately to severely active IBD and can be used to evaluate treatment response.

Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.

BACKGROUND: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers' reporting using similar clinical outcome assessments. OBJECTIVE: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. METHODS: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients' electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. RESULTS: Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients' hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. CONCLUSIONS: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

Patient-reported outcomes measurement information system depression psychometrically underperforms compared to legacy measures and is poorly associated with postoperative functional outcomes in shoulder arthroplasty patients.

Background: The purpose of this study was to investigate the associations between each mental health patient-reported outcome measure with postoperative functional outcomes following shoulder arthroplasty, and to compare psychometric properties of patient-reported outcomes measurement information system depression to the legacy (VR-12 Mental) patient-reported outcome measure. Methods: Patients who underwent primary shoulder arthroplasty from July 2018 to February 2019 were retrospectively reviewed. Patient-reported outcomes measurement information system depression and VR-12 Mental were administered preoperatively; American Shoulder and Elbow Surgeons and Single Assessment Numeric Evaluation were administered at 6-month and 1-year postoperatively. Rasch partial credit modeling analysis was used to compare psychometric properties of legacy versus patient-reported outcomes measurement information system instruments in assessing mental health. Results: Ninety-three patients who underwent total shoulder arthroplasty (n = 52), reverse total shoulder arthroplasty (n = 39), or hemiarthroplasty (n = 2) were included. Preoperative VR-12 Mental scores were moderately associated with American Shoulder and Elbow Surgeons at 6-months (coefficient: 0.52, P = 0.026) and 1-year (coefficient: 0.65, P = 0.002), while preoperative patient-reported outcomes measurement information system depression scores were not. Patient-reported outcomes measurement information system depression demonstrated significant floor effects (16%); VR-12 Mental demonstrated minimal floor and ceiling effects (1.1% for both). VR-12 Mental demonstrated broader coverage of mental outlook on Rasch modeling than patient-reported outcomes measurement information system depression and had adequate model fit after one round of reiterative item elimination. Discussion: Patient-reported outcomes measurement information system depression was poorly associated with postoperative American Shoulder and Elbow Surgeons scores, demonstrated significant floor effects, and had limited coverage of mental health on Rasch modeling with reiterative elimination. Level of Evidence: IV.

Dutch-Flemish translation and validation of the gastrointestinal symptom scales from the patient­reported outcomes measurement information system (PROMIS)®.

PURPOSE: To translate the eight PROMIS® GastrointestinaI Symptom Scales into Dutch-Flemish and to evaluate their psychometric properties. METHODS: This study consisted of two parts: (1) translation according to the Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology and (2) evaluation of psychometric properties: structural validity, using confirmatory factor analysis; and construct validity using hypothesis testing. RESULTS: In the first part of the study, in 19 out of the 77 items (24.7%) translation was challenging. After discussion between the translators, consensus could be achieved. In the cognitive debriefing interview phase, ten minor changes in the wording of items were made. A universal Dutch-Flemish translation for all 77 items was obtained. In de second part of the study a good fit was found for three DF-PROMIS GI Scales: Bowel Incontinence, Gas and Bloating, and Belly Pain. Four scales (Reflux, Disrupted Swallowing, Diarrhea, and Constipation) did not show sufficient fit and fit for the Nausea and Vomiting scale could not be assessed because of skewed responses. Construct validity was considered sufficient for six out of eight DF-PROMIS GI Scales. Less than 75% of hypothesis for de Constipation and Disrupted Swallowing scales could be confirmed. CONCLUSION: The PROMIS GI Symptom Scales were successfully translated into DutchFlemish. The findings suggest a sufficient structural validity for the PROMIS GI Scales. Bowel Incontinence, Gas and Bloating and Belly Pain. Construct validity was sufficient for the Scales Gas and Bloating, Incontinence, Nausea and Vomiting, Reflux, Belly Pain, and Diarrhea.

Telemedicine-Based Digital Cognitive Behavioral Intervention for Perioperative Anxiety and Depression for Total Knee Arthroplasty.

Introduction: Preoperative anxiety and depression have been shown to increase postoperative pain and opioid consumption by up to 50% in patients undergoing primary unilateral Total Knee Arthroplasty (TKA). We hypothesized that the use of a telemedicine-based digital Cognitive Behavioral Intervention program (RxWell®) started one month prior to surgery would control anxiety and depression prior to surgery. Materials and methods: This was a randomized, controlled trial that enrolled patients undergoing primary unilateral TKA. At least a month prior to surgery, patients who gave consent to participate were asked to complete PROMIS® (Patient-Reported Outcomes Measurement Information System) emotional anxiety short form 8a and PROMIS® emotional depression short form-8a questionnaires. Patients with T-scores of ≥ 57 were randomized to either a no intervention (control group) or a RxWell® program (treatment group) for a month prior to surgery. The primary outcome of this proof-of-concept study was the ability of the RxWell® to normalize patients' PROMIS anxiety T scores. Results: T scores for anxiety and depression among patients randomized to the RxWell® group significantly decreased from 64.3 ± 3.0 at the time of randomization to 58.5 ± 2.6 prior to surgery (n=5, p=0.006), whereas no changes in T scores were recorded in the control group (59.4 ± 4.2 at the time of randomization vs. 57.7 ± 6.2; n=6, p=0.559). Conclusion: These preliminary data suggest that the use of a RxWell® program represents an effective approach to control anxiety and depression prior to surgery. In contrast, it seems that in the absence of treatment, anxiety level remains similar over a month prior to surgery.

The effect of a workplace wellness program on disability, function and pain in healthcare providers workers with low back pain-outcomes of 3040 academic health center employees.

PURPOSE: (1) Identification of musculoskeletal risk factors for healthcare providers suffering low back pain (LBP) and the creation of risk profiles for those individuals and (2) analyze the impact of a workplace wellness program on healthcare providers who suffer from low back pain. METHODS: A total of 3040 employees at an academic healthcare center underwent a computer-adaptive survey of health-related quality of life (HRQOL), biometric tests, and a disability and functional movement assessment as part of the workplace wellness program (WWP). Clinical interventions with a rehabilitation specialist were offered to employees identified as at risk for low back pain. Data collected were analyzed using descriptive methods and multivariable regressions to address the study objectives. RESULTS: Of the 3040 healthcare providers enrolled in this study, 77% identified with non-specific LBP with greater weakness, numbness, reduced flexibility, and physical activity. The major predictive risk factors for LBP were Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score, PROMIS fatigue, previous work injury, flexibility, numbness, PROMIS social function, level of education, and BMI. Healthcare providers with LBP who completed the WWP improved in most dimensions of HRQOL and disability and functional outcomes. CONCLUSIONS: A high proportion of healthcare providers suffer from LBP as a result of the nature of their work. Disability and functional outcomes measurements and PROMIS results quantitatively assess healthcare providers with LBP. Organizations can develop injury mitigation programs to target employees at high risk of LBP using the risk factors we identify. Completion of the WWP was associated with improvements in disability, HRQOL and functional measures.