Utility of Patient Reported Outcome Measurement Information System measures in predicting shoulder arthroplasty in patients with shoulder osteoarthritis.

BACKGROUND: The decision to treat shoulder osteoarthritis (OA) definitively with shoulder arthroplasty (SA) is multifactorial, considering objective findings, subjective information, and patient goals. The first goal of this study was to determine if Patient Reported Outcome Measurement Information System (PROMIS) measures correlated with patients with shoulder OA who underwent SA within 1 year. The second goal of this study was to determine if score cut-offs in PROMIS domains could further discriminate which shoulder OA patients underwent SA within 1 year. METHODS: This retrospective case-control study examined patients with a diagnosis of shoulder OA who consulted an orthopedic provider from November 1, 2020 to May 23, 2022, and recorded PROMIS measures in the domains of Physical Function, Depression, and/or Pain Interference. A surgical group was defined as patients who underwent SA within 1 year of the most recent PROMIS measures and the nonsurgical patients were defined as the control group. Mean PROMIS scores were compared between the surgical and control groups. Separate logistic regression models controlling for age, race, ethnicity, and comorbidity count were performed for each PROMIS domain as a 1) continuous variable, and then as 2) binary variable defined by PROMIS score cut-off points to determine which scores correlated with undergoing SA to further characterize the potential clinical utility of PROMIS score cut-offs in relating to undergoing SA. RESULTS: The surgical group of 478 patients was older (68.2 vs. 63.8 years), more often of White race (82.6% vs. 70.9%), and less often of Hispanic Ethnicity (1.5% vs. 2.9%) than the control group of 3343 patients. Using optimal cut-offs in PROMIS scores, Pain Interference ≥63 (odds ratio [OR] = 2.97 (2.41-3.64), P < .001), Physical Function ≤39 (OR = 1.81 (95% confidence interval, 1.48-2.22), P < .001), and depression ≥49 (OR = 1.82 (95% confidence interval, 1.50-2.22), P < .001) were all found to correlate with undergoing SA within 1 year in multivariable logistic regressions. CONCLUSION: The results of this study demonstrate that cut-off scores for PROMIS measures differentiated patients undergoing SA within 1 year. These cut-off scores may have clinical utility in aiding in decision-making regarding surgical candidates for SA. Further research is needed to validate these cut-off scores and determine how they relate to patient outcomes after SA.

Patient-Reported Outcomes Measurement Information System in patients with gastrointestinal cancer: a scoping review.

PURPOSE: The purpose of this study was to identify and evaluate the use of the Patient-Reported Outcomes Measurement Information System in patients with gastrointestinal cancer, as well as provide references for analyzing treatment outcomes, gauging prognostic risk, and assessing clinical symptoms and function in gastrointestinal cancer patients. METHODS: PubMed, Web of Science, ProQuest, Embase, and CINAHL were systematically searched using keywords and controlled vocabulary through January 2023. RESULTS: The scoping review collected 30 studies published from 2012 to 2022, including observational studies (n = 21), interventional studies (n = 4), and mixed studies (n = 5). Outcome indicators included mood, pain, fatigue, sleep, the ability to perform activities of daily living, social functioning, and other health problems. CONCLUSION: Being a self-report questionnaire, the Patient-Reported Outcomes Measurement Information System offers a full assessment of patient's symptoms and quality of life, and accurately captures their actual thoughts, feelings, and experiences. Individuals with gastrointestinal cancer made frequent use of the Patient-Reported Outcomes Measurement Information System to provide an accurate measure of their health status.

Comparison of the PROMIS Preference Score (PROPr) and EQ-5D-5L Index Value in General Population Samples in the United Kingdom, France, and Germany.

OBJECTIVES: The Patient-Reported Outcome Measurement Information System (PROMIS) Preference score (PROPr) can be used to assess health state utility (HSU) and estimate quality-adjusted life-years in cost-effectiveness analyses. It is based on item response theory and promises to overcome limitations of existing HSU scores such as ceiling effects. The PROPr contains 7 PROMIS domains: cognitive abilities, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. We aimed to compare the PROPr with the 5-level EQ-5D (EQ-5D-5L) in terms of psychometric properties using data from 3 countries. METHODS: We collected PROMIS-29 profile and EQ-5D-5L data from 3 general population samples (United Kingdom = 1509, France = 1501, Germany = 1502). Given that cognition is not assessed by the PROMIS-29, it was predicted by the recommended linear regression model. We compared the convergent validity, known-groups construct validity, and ceiling and floor effects of the PROPr and EQ-5D-5L. RESULTS: The mean PROPr (0.48, 0.53, 0.48; P<.01) and EQ-5D-5L scores (0.82, 0.85, 0.83; P<.01) showed significant differences of similar magnitudes (d = 0.34; d = 0.32; d = 0.35; P<.01) across all samples. The differences were invariant to sex, income, occupation, education, and most conditions but not for age. The Pearson correlation coefficients between both scores were r = 0.74, r = 0.69, and r = 0.72. PROPr's ceiling and floor effects both were minor to moderate. The EQ-5D-5L's ceiling (floor) effects were major (negligible). CONCLUSIONS: Both the EQ-5D-5L and the PROPr assessed by the PROMIS-29 show high validity. The PROPr yields considerably lower HSU values than the EQ-5D-5L. Consequences for quality-adjusted life-year measurements should be investigated in future research.

The Significance of Race/Ethnicity and Income in Predicting Preoperative Patient-Reported Outcome Measures in Primary Total Joint Arthroplasty.

BACKGROUND: Utilization of total joint arthroplasty (TJA) by minorities is disproportionately low compared to Whites. Contributing factors include poorer outcomes, lower expectations, and decreased access to care. This study aimed to evaluate if race and income were predictive of preoperative patient-reported outcome measures (PROMs) and the likelihood of achieving the minimal clinically important difference (MCID) following TJA. METHODS: We retrospectively reviewed 1,371 patients who underwent primary TJA between January 2018 and March 2021 in a single healthcare system. Preoperative and postoperative PROM scores were collected for Patient-Reported Outcomes Measurement Information System (PROMIS) Mental Health, PROMIS Physical Function (PF10a), and either Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS). Demographic and comorbidity data were included as explanatory variables. Multivariable regression was used to analyze the association between predictive variables and PROM scores. RESULTS: Mean preoperative PROM scores were lower for non-Whites compared to Whites. Increased median household income was associated with higher preoperative PROM scores. Non-White race was associated with lower PROMIS Mental Health and KOOS, but not PF10a or HOOS scores. Only non-White race was associated with a decreased likelihood of achieving MCID for PF10a. Neither race nor income was predictive of achieving MCID for KOOS and HOOS. CONCLUSION: Non-White race/ethnicity and lower income were associated with lower preoperative PROMs prior to primary TJA. Continued research is necessary to identify the causes of this discrepancy and correct this disparity.

Relationship Between the Patient-Reported Outcome Measurement Information System and Traditional Patient-Reported Outcomes for Osteoarthritis.

BACKGROUND: Incorporating patient-reported outcomes (PROs) is paramount to the creation of a value-based healthcare system that prioritizes patient-centered care in total joint arthroplasty. The relationship between global assessment PROs such as Patient-Reported Outcome Measurement Information System (PROMIS) and joint-specific PROs for hip and knee, such as short form variations of Knee Injury and Osteoarthritis Outcome Score (KOOS-JR) and Hip Injury and Osteoarthritis Outcome Score (HOOS-JR), has yet to be assessed. METHODS: A retrospective analysis was conducted to assess PRO measurements for knee-related and hip-related complaints. The KOOS-JR and HOOS-JR were compared to the PROMIS computerized adaptive test (CAT) short forms (physical function, pain interference, and pain intensity) to assess their relationship. RESULTS: A total of 3644 patients completed 4609 questionnaires. A modest to strong correlation was observed between the KOOS-JR and the PROMIS CAT (ranging from r = 0.56 to -0.71, P < .05). A modest to strong correlation was also found between the HOOS-JR and the PROMIS CAT (r = 0.59 to -0.79, P < .05). CONCLUSION: PROMIS CATs demonstrated a modest to strong correlation with KOOS-JR or HOOS-JR. Future studies should further investigate the limitations of global assessment health surveys in capturing disease-specific changes following total joint arthroplasty.

The PROMIS fatigue item bank has good measurement properties in patients with fibromyalgia and severe fatigue.

PURPOSE: Efficient management of fibromyalgia (FM) requires precise measurement of FM-specific symptoms. Our objective was to assess the measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue item bank (FIB) in people with FM. METHODS: We applied classical psychometric and item response theory methods to cross-sectional PROMIS-FIB data from two samples. Data on the clinical FM sample were obtained at a tertiary medical center. Data for the U.S. general population sample were obtained from the PROMIS network. The full 95-item bank was administered to both samples. We investigated dimensionality of the item bank in both samples by separately fitting a bifactor model with two group factors; experience and impact. We assessed measurement invariance between samples, and we explored an alternate factor structure with the normative sample and subsequently confirmed that structure in the clinical sample. Finally, we assessed whether reporting FM subdomain scores added value over reporting a single total score. RESULTS: The item bank was dominated by a general fatigue factor. The fit of the initial bifactor model and evidence of measurement invariance indicated that the same constructs were measured across the samples. An alternative bifactor model with three group factors demonstrated slightly improved fit. Subdomain scores add value over a total score. CONCLUSIONS: We demonstrated that the PROMIS-FIB is appropriate for measuring fatigue in clinical samples of FM patients. The construct can be presented by a single score; however, subdomain scores for the three group factors identified in the alternative model may also be reported.

Negative affect and sleep disturbance may be associated with response to epidural steroid injections for spine-related pain.

OBJECTIVE: To describe whether negative affect and sleep impairment are associated with the clinical effect of epidural steroid injections (ESIs) for low back pain. DESIGN: Observational study; patients were evaluated before ESI and 1 and 3 months after ESI. SETTING: Spine center and related treatment sites. PARTICIPANTS: Participants (N=158) seeking treatment for low back pain with or without radiculopathy. INTERVENTION: ESI for low back pain with or without radiculopathy. MAIN OUTCOME MEASURES: We assessed the dependent (global pain severity for back and leg pain, pain behavior, pain interference) and independent variables (depression, sleep disturbance, and covariates of back pain response) with the Patient-Reported Outcome Measurement Information System (PROMIS) and legacy measures. Outcome was assessed cross-sectionally using multiple regression and longitudinally with path analysis. RESULTS: After 1 month, sleep disturbance was the only predictor for the global ratings of improvement in back pain (R(2)=16.8%) and leg pain (R(2)=11.4%). The proportions of variance explained by sleep disturbance and negative affect for all dependent variables were greater at 3 months than 1 month. Mediation analysis was significant for negative affect for the 3-month outcomes on PROMIS pain behavior (ß=.87, P<.01) and pain interference (ß=.37, P<.01). There was no evidence of mediation by sleep disturbance for any outcome. CONCLUSIONS: Negative affect and sleep disturbance are associated with worse outcomes after ESI. Further research is needed to determine if treatment of negative affect and sleep disturbance prior to or concurrently with ESI will improve outcomes.

Intergenerational transmission of adverse and positive childhood experiences and associations with child well-being.

BACKGROUND: Parental adverse childhood experiences (ACEs) contribute to offspring adversity and poor health outcomes, but little is known about whether and to what extent parental positive childhood experiences (PCEs) influence offspring positive experiences and well-being. OBJECTIVE: To investigate the association between parent and child ACEs and PCEs and their impact on child well-being and psychopathology. PARTICIPANTS AND SETTING: A national sample of n = 1016 US parents of 1-5-year-olds completed online surveys in September 2019. METHODS: Mediation analysis in a path modeling framework was used with stratified probability weights for generalizability to the US population. RESULTS: Each additional parent PCE equated to 0.32 (95 % CI: 0.20, 0.45) increase in child PCEs and each additional parent ACE equated to 0.18 (95 % CI: 0.06, 0.31) increase in child PCEs and 0.13 (95 % CI: 0.08, 0.18) increase in child ACEs. In turn, an increase in 1 child PCE was associated with 0.10-0.16 SD increase in well-being and 0.06-0.10 decrease in psychopathology, and each additional child ACE equated to 0.10-0.18 SD increase in psychopathology. CONCLUSIONS: Results support the intergenerational transmission of PCEs and ACEs, advancing understanding of the role that parent PCEs play in promoting child PCEs and fostering child well-being. Findings underscore the importance of extending clinical surveillance of ACEs to include PCEs in pediatric and adult healthcare settings. Dual-generation programs that address the negative consequences of parental ACEs may be able to increase their impact by adding a parallel emphasis on PCEs and providing parents with tools to foster PCEs in their children.

Association between opioid utilization and patient-reported outcome measures following lumbar spine surgery.

BACKGROUND CONTEXT: The patient-reported outcomes measurement information system (PROMIS), created by the National institute of Health, is a reliable and valid survey for patients with lumbar spine pathology. Preoperative opioid use has been shown to be an important predictor variable of self-reported health status in legacy patient-reported outcome measures. PURPOSE: To investigate the impact of chronic preoperative opiate use on PROMIS survey scores. STUDY DESIGN: Retrospective database analysis. PATIENT SAMPLE: Between March 2019 and November 2021, 227 patients underwent lumbar decompression ± ≤ 2 level fusion. Fifty-seven patients (25.11%) had chronic preoperative opioid use. OUTCOME MEASURES: Oswestry disability index (ODI) and PROMIS survey scores. METHODS: A retrospective analysis of a prospectively maintained single center patient-reported outcome database was performed with a minimum of 2 year follow-up. PROMIS Anxiety, Depression, Fatigue, Pain Interference (PI), Physical Function (PF), Sleep disturbance (SD), and Social Roles (SR) surveys were recorded at preoperative intake with subsequent follow-up at 6, 12, and 24 months postoperatively. Patients were grouped into chronic opioid users as defined by >6-month duration of use. Differences in mean survey scores were evaluated using Welch t-tests. RESULTS: Two hundred and twenty-seven patients met our inclusion criteria of completed PROMIS surveys at the designated timepoints. A total of 57 (25.11%) were chronic opioid users (COU) prior to surgery. Analysis of patient-reported health outcomes shows that long term opioid use correlated with worse ODI and PROMIS scores at baseline compared to nonchronic users (NOU). At 1 and 2 year follow-up, the COU cohort continued to have significantly worse ODI, PROMIS Fatigue, PF, PI, SD, and SR scores. There is a statistical difference in the magnitude of change in health status between the 2 cohorts at 1 year follow-up in PROMIS Depression (-5.04±7.88 vs -2.49±8.73, p=.042), PF (6.25±7.11 vs 9.03±9.04, p=.019), and PI (-7.40±7.37 vs -10.58±9.87, p=.011) and 2 year follow-up in PROMIS PF (5.58±6.84 vs 7.99±9.64, p=.041) and PI (-6.71±8.32 vs -9.62±10.06, p=.032). Mean improvement in PROMIS scores for the COU cohort at 2 year follow-up exceeded minimal clinically important difference (MCID) in all domains except PROMIS Depression, SR and SD. CONCLUSION: Patients with chronic opioid use status have worse baseline PROMIS scores compared with patients who had nonchronic use. However, patients in the COU cohort displayed clinically significant postoperative improvement in multiple PROMIS domains. These results show that patients with chronic opioid use can benefit greatly from surgical intervention and will allow physicians to better set expectations with their patients.

Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS®) physical function questionnaire in late-onset Pompe disease using PROPEL phase 3 data.

BACKGROUND: The construct validity and interpretation of the Patient-Reported Outcome Measurement Information System (PROMIS®) Physical Function short form 20a (PF20a) questionnaire were evaluated for patients with late-onset Pompe disease (LOPD), a rare, autosomal recessive, progressive neuromuscular disorder treatable by enzyme replacement therapy (ERT). METHODS: In the phase 3 PROPEL study, adults with LOPD underwent testing of physical functioning and had PRO measurements at baseline and at weeks 12, 26, 38, and 52 while receiving experimental or standard-of-care ERT. All patients were pooled for analyses, without comparisons between treatment groups. Associations and correlations between PROMIS PF20a scores and the 6-minute walk distance (6MWD), % predicted forced vital capacity (FVC), manual muscle test (MMT) of the lower extremities, Gait, Stairs, Gowers' maneuver, Chair (GSGC) score, and Rasch-built Pompe-specific Activity (R-PAct) scale were evaluated by calculating regression coefficients in linear regression models and Pearson correlation coefficients (R); patients' age, sex, race, ERT prior to study, body mass index, and study treatment were included as covariables. The minimal clinically important difference (MCID) of PROMIS PF20a was determined using distribution- and anchor-based methods. RESULTS: 123 patients received at least 1 dose of ERT. In multivariable analyses, PROMIS PF20a scores had strong correlations with R-PAct scores (R = 0.83 at baseline and R = 0.67 when evaluating changes between baseline and 52 weeks) and moderate correlations with the 6MWD (R = 0.57 at baseline and R = 0.48 when evaluating changes between baseline and 52 weeks). Moderate correlations were also observed between PROMIS PF20a and MMT (R = 0.54), GSGC (R=-0.51), and FVC (R = 0.48) at baseline. In multivariable linear regression models, associations were significant between PROMIS PF20a and 6MWD (P = 0.0006), MMT (P = 0.0034), GSGC (P = 0.0278), and R-PAct (P < 0.0001) at baseline, between PROMIS PF20a and 6MWD (P < 0.0001), FVC (P = 0.0490), and R-PAct (P < 0.0001) when combining all measurements, and between PF20a and 6MWD (P = 0.0016) and R-PAct (P = 0.0001) when evaluating changes in scores between baseline and 52 weeks. The anchor-based and distribution-based MCID for a clinically important improvement for PROMIS PF20a were 2.4 and 4.2, respectively. CONCLUSIONS: PROMIS PF20a has validity as an instrument both to measure and to longitudinally follow physical function in patients with LOPD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03729362. Registered 2 November 2018, https://www. CLINICALTRIALS: gov/search?term=NCT03729362 .

Associations of musculoskeletal dysfunction, time to brake, and patient reported outcomes following lower extremity trauma.

INTRODUCTION: Inability to drive a motor vehicle due to lower extremity injury is a major inconvenience. Timing of safe return to driving has not been much studied. Objective measurements such as time to brake (TTB) have been proposed; however, utility and concordance of functional outcome measurements have not been previously evaluated. The purpose of this project is to measure these parameters and to assess for associations with ability to safely return to driving, improving the ability of clinicians to assess for measurements of driving readiness without specifically measuring TTB. METHODS: A prospective, cohort study of 232 patients with complex lower extremity injuries to the pelvis, acetabulum, hip, femur, knee, tibia, ankle, and foot was performed. Time to brake (TTB) was measured once weightbearing was allowed. Function was assessed by the Musculoskeletal Function Assessment (MFA) questionnaire, and pain, mobility, and physical functions, via patient reported outcome measurement information system (PROMIS) surveys. RESULTS: Patients with longer TTB had significantly elevated MFA scores indicating increased musculoskeletal dysfunction post-injury. As the MFA score increased by 1 point, TTB increased by 0.013 s (p<0.001). PROMIS metrics were also significantly associated with patients experiencing more pain and worse mobility as TTB increased. DISCUSSION: Many patients continue to exhibit musculoskeletal dysfunction several months post-treatment for complex lower extremity injuries. Patients with better PROMIS metrics and MFA scores, and shorter TTB are more appropriate to return to driving. Surgeons may be better informed about safe driving ability by considering these measurements. LEVEL OF EVIDENCE: II.

Development and assessment of a community follow-up questionnaire for the Rick Hansen spinal cord injury registry.

OBJECTIVE: To develop a comprehensive community follow-up questionnaire for participants enrolled in the Rick Hansen Spinal Cord Injury Registry (RHSCIR). DESIGN: Development and preliminary assessment of measurement properties (reliability and validity) of instruments used during a community follow-up and aligned with the International Classification of Functioning, Disability and Health (ICF). SETTING: General community setting. PARTICIPANTS: People with spinal cord injury (N=50) living in the community. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: A comprehensive follow-up questionnaire, referred to as the RHSCIR Community Follow-up Questionnaire Version 2.0 (CFQ-V2.0), includes 8 instruments. Four new instruments were developed, 2 existing instruments were modified, and 2 previously published instruments were included. RESULTS: Intra- and interrater reliability statistics (Gwet's AC1) support the measurement properties of the new and modified instruments. Correlations between new and existing instruments and between groups based on the severity of injury support the construct validity of the secondary complications and person-perceived participation instruments. CONCLUSIONS: The RHSCIR CFQ-V2.0 is a comprehensive community follow-up questionnaire that aligns to the ICF. Initial study results suggest that it covers all relevant aspects of community living, and the measurement properties are promising.

Psychometric properties of the Chinese version of the PROMIS-Cancer-Anxiety item bank assessed using a graded response model.

Objective: This study aimed to examine the psychometric properties of the Chinese version of the Patient-Reported Outcome Measurement Information System (PROMIS)-Cancer-Anxiety item bank using a graded response model in a sample of patients with cancer. Methods: A cross-sectional study was conducted and the Chinese version of the PROMIS-Cancer-Anxiety item bank was used to measure anxiety in patients with cancer. The unidimensional structure of the item bank was evaluated using principal component analysis. Residual correlations and the graphs of item mean scores conditional on the rest scores were examined to evaluate the local independence and monotonicity of the items, respectively. Item characteristics were described using item parameter estimates and item information. Operating characteristic curves (OCCs) and test information curve (TIC) were also plotted. Measurement invariance across age, gender, and education level was assessed to identify possible differential item functioning (DIF). Results: A total of 1075 patients with cancer were enrolled. Under the assumptions of unidimensionality, local independence, and monotonicity, the discrimination parameters a ranged from 2.30 to 5.47, and the threshold parameters b ranged from b1 = -2.87 to b4 = 3.21 with proper intervals. Completely overlapped category curves were not observed among the OCCs of any items. Item information and TIC showed that the item bank had a wide measurement range. The DIFs for age, gender, and education level for all items were not remarkable. Conclusions: The results supported using the Chinese version of the PROMIS-Cancer-Anxiety item bank to measure anxiety and develop a computerized adaptive testing (CAT) system for anxiety in patients with cancer.

Determining the Time Required to Achieve Clinically Significant Outcomes on the PROMIS Upper Extremity Questionnaire After Arthroscopic Rotator Cuff Repair.

Background: Clinically significant outcome (CSO) thresholds for the Patient-Reported Outcome Measurement Information System-Upper Extremity (PROMIS-UE) score have been previously defined after arthroscopic rotator cuff repair (RCR). However, the time required to achieve CSOs for the PROMIS-UE score is unknown. Purpose: To (1) determine the time required to achieve the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) score thresholds after RCR for the PROMIS-UE questionnaire and (2) identify patient factors associated with earlier or delayed achievement of these clinical benchmarks. Study Design: Case-control study; Level of evidence, 3. Methods: A prospectively maintained institutional database was retrospectively reviewed for consecutive patients who underwent RCR between January 2018 and January 2019. Patients were included if they completed the PROMIS-UE questionnaire both preoperatively and at standardized postoperative time intervals: 5 to 7 months (6-month time point), 11 to 13 months (1-year time point), and ≥23 months (2-year time point). Kaplan-Meier survival curves with interval censoring were used to define the cumulative percentage of patients who achieved the MCID, SCB, and PASS. Patient variables associated with earlier or delayed achievement of the MCID, SCB, and PASS were determined using Weibull parametric survival regression analysis. Results: Included were 105 patients undergoing RCR (age, 57.3 ± 10.3 years; body mass index, 31.5 ± 6.1 kg/m2). By 2-year follow-up, the cumulative percentage of patients achieving the MCID, SCB, and PASS was 86.7%, 76.2%, and 74.3%, respectively. The mean time required to reach the MCID, SCB, and PASS score thresholds was 9.5 ± 3.8, 10.3 ± 4.4, and 9.8 ± 4.6 months, respectively. Factors associated with delayed achievement of CSOs included greater baseline PROMIS-UE score (MCID and SCB) and workers' compensation insurance (PASS). Greater baseline PROMIS-UE scores were associated with earlier achievement of the PASS. Conclusion: Most patients achieved CSOs for the PROMIS-UE within 12 months of RCR. Patient-specific factors found to be associated with earlier or delayed achievement of CSOs can be used to inform patient discussions on the expected timeline for recovery after RCR.

Empirical Priors in Polytomous Computerized Adaptive Tests: Risks and Rewards in Clinical Settings.

The use of empirical prior information about participants has been shown to substantially improve the efficiency of computerized adaptive tests (CATs) in educational settings. However, it is unclear how these results translate to clinical settings, where small item banks with highly informative polytomous items often lead to very short CATs. We explored the risks and rewards of using prior information in CAT in two simulation studies, rooted in applied clinical examples. In the first simulation, prior precision and bias in the prior location were manipulated independently. Our results show that a precise personalized prior can meaningfully increase CAT efficiency. However, this reward comes with the potential risk of overconfidence in wrong empirical information (i.e., using a precise severely biased prior), which can lead to unnecessarily long tests, or severely biased estimates. The latter risk can be mitigated by setting a minimum number of items that are to be administered during the CAT, or by setting a less precise prior; be it at the expense of canceling out any efficiency gains. The second simulation, with more realistic bias and precision combinations in the empirical prior, places the prevalence of the potential risks in context. With similar estimation bias, an empirical prior reduced CAT test length, compared to a standard normal prior, in 68% of cases, by a median of 20%; while test length increased in only 3% of cases. The use of prior information in CAT seems to be a feasible and simple method to reduce test burden for patients and clinical practitioners alike.

Adding Centralized Electronic Patient-Reported Outcome Data Collection to an Established International Clinical Outcomes Registry.

The importance of patient-reported outcomes (PROs) in cellular therapies, including hematopoietic cell transplantation (HCT) is highlighted in this study. Longitudinal collection of PROs in a registry is recommended for several reasons, yet to date, PROs are not routinely collected from HCT patients to augment clinical registry data. The aim of this study was to determine the feasibility of electronic PRO data collection by a national clinical outcomes registry, by assessing differences between who does and does not report PROs. We conducted a cross-sectional pilot collection of PROs from HCT recipients after treatment using computer-adapted tests from the Patient-Reported Outcome Measurement Information System (PROMIS). We implemented centralized data collection through the Center for International Blood and Marrow Transplant Research (CIBMTR) among patients who underwent HCT for myelodysplastic syndromes (MDS), were at least 6 months post-HCT, and spoke English or Spanish. The main objective was identifying patient, disease, and transplant-related differences associated with completion of electronic PROs. Patients were excluded from analysis if they were determined to be ineligible (deceased, did not speak English or Spanish, refused to be contacted by the CIBMTR). A total of 163 patients were contacted and potentially eligible to participate; of these, 92 (56%) enrolled and 89 (55%) completed the PRO assessment. The most frequent reason for incomplete surveys was inability to contact patients (n = 88), followed by declining to participate in the study (n = 37). There were no sociodemographic or age differences between those who completed the PRO survey (n = 89) and eligible nonresponders (n = 155). Patient scores were within 3 points of the US average of 50 for all symptoms and functioning except physical functioning. Responders and nonresponders did not exhibit meaningfully different sociodemographic characteristics. Difficulty contacting patients posed the greatest barrier and also provided the greatest opportunity for improvement. Once enrolled, survey completion was high. These results support standardizing centralized PRO data collection through the CIBMTR registry.

Measuring Mood and Anxiety Disorders by Patient Reported Outcomes in Inflammatory Bowel Disease: A Literature Review Update.

Background Anxiety and depression are the most common psychological disorders found in Inflammatory Bowel Disease (IBD) patients. Accurate measuring of these disorders should be proposed for a prompt management. Patient-reported outcome measurements (PROMs) allow patients to self-report their psychological symptoms. Objective To highlight the presence of PROMs measuring anxiety and depression in IBD setting evaluating the most used psychometric tools. Methods We reviewed the literature from 2010 up to September 2021. Articles on adult IBD patients assessing depression and anxiety by PROMs in English language were included. Results Thirty-six studies, including 11 psychometric tools were found. Hospital Anxiety and Depression Scale (21 studies), Beck Depression Inventory II (5 studies), Spielberg State-Trait Anxiety Inventory (3 studies), Patient-Reported Outcomes Measurement Information System (3 studies), Symptom Checklist-90 (2 studies), Euro Quality of Life (2 studies) mostly used psychometric tools for anxiety and depression in IBD settings. Conclusion Our review analyzed psychometric tools used for PROMs evaluating anxiety and depression in IBD setting. No chronological differences have emerged, all have been used in the last ten years, highlighting a lack of specificity. The strong association between IBD and mood disorders suggests that clinicians should consider the evaluation of depression and anxiety as integral parts of IBD clinical care. It is essential to identify tools enabling these items to be detected better. A global view of IBD patients, accounting not only for physical but also for psychical symptoms with an early and feasible assessment of unrecognized psychiatric disorders, can have a strong impact on their management strategy.

Cognitive impairment is associated with greater preoperative symptoms, worse health-related quality of life, and reduced likelihood of recovery after cervical and lumbar spine surgery.

Background: Cognitive impairment (CI) is associated with prolonged hospital stays and increased complications; however, its role in symptom severity and health-related quality of life (HRQoL) among spine patients is unknown. We determined 1) prevalence of preoperative CI; 2) associations between CI and preoperative pain, disability, and HRQoL; and 3) association between CI and postoperative improvements in HRQoL. Methods: This is a prospective cohort study of 453 consecutive adult spine surgery patients between October 2019 and March 2021. We compared pain (Numeric Rating Scale, NRS), pain-related disability (Oswestry/Neck Disability Index, O/NDI), and HRQoL (PROMIS-29 profile, version 2.0) among participants having severe (PROMIS-29 Cognitive Abilities score ≤30), moderate (31-35), or mild CI (36-40) or who were unimpaired (score >40), using analysis of variance. Likelihood of clinical improvement given the presence of any CI was estimated using logistic regression. All comparisons were adjusted for age, gender, comorbidity, and use of opioid medication during the last 30 days. Alpha=.05. Results: Eighty-five respondents endorsed CI (38 mild; 27 moderate; 20 severe). Preoperatively, those with CI had more severe back pain (p=.005) and neck pain (p=.025) but no differences in leg or arm pain. Those with CI had greater disability on ODI (p<.001) and NDI (p<.001) and worse HRQoL in all domains (all, p<.001). At 6 and 12 months postoperatively, those with CI were less likely to experience clinical improvement in disability and HRQoL (anxiety, pain interference, physical function, and satisfaction with ability to participant in social roles) (all, p<.05). Conclusions: CI was present in nearly 20% of spine patients before surgery and was independently associated with worse preoperative back and neck pain, disability, and HRQoL. Those with CI had approximately one-half the likelihood of achieving meaningful clinical improvement postoperatively. These results indicate a need to evaluate spine patients' cognitive impairment prior to surgery. Level of Evidence: III.

The burden of non-alcoholic steatohepatitis: A systematic review of health-related quality of life and patient-reported outcomes.

Background & Aims: Non-alcoholic steatohepatitis (NASH) is associated with increased mortality and a high clinical burden. NASH adversely impacts patients' health-related quality of life (HRQoL), but published data on the humanistic burden of disease are limited. This review aimed to summarise and critically evaluate studies reporting HRQoL or patient-reported outcomes (PROs) in populations with NASH and identify key gaps for further research. Methods: Medline, EMBASE, the Cochrane Library and PsycINFO were searched for English-language publications published from 2010 to 2021 that reported HRQoL/PRO outcomes of a population or subpopulation with NASH. Results: Twenty-five publications covering 23 unique studies were identified. Overall, the data showed a substantial impact of NASH on HRQoL, particularly in terms of physical functioning and fatigue, with deterioration of physical and mental health as NASH progresses. Prevalent symptoms, including fatigue, abdominal pain, anxiety/depression, cognition problems, and poor sleep quality, adversely impact patients' ability to work and perform activities of daily living and the quality of relationships. However, some patients fail to attribute symptoms to their disease because of a lack of patient awareness and education. NASH is associated with high rates of comorbidities such as obesity and type 2 diabetes, which contribute to reduced HRQoL. Studies were heterogeneous in terms of diagnostic methods, population, outcomes, follow-up time, and measures of HRQoL/utility. Most studies were rated 'moderate' at quality assessment, and all evaluable studies had inadequate control of confounders. Conclusions: NASH is associated with a significant HRQoL burden that begins early in the disease course and increases with disease progression. More robust studies are needed to better understand the humanistic burden of NASH, with adequate adjustment for confounders that could influence outcomes. Lay summary: Non-alcoholic steatohepatitis (NASH) has a significant impact on quality of life, with individuals experiencing worse physical and mental health compared with the general population. NASH and its symptoms, which include tiredness, stomach pain, anxiety, depression, poor focus and memory, and impaired sleep, affect individuals' relationships and ability to work and perform day-to-day tasks. However, not all patients are aware that their symptoms may be related to NASH. Patients would benefit from more education on their disease, and the importance of good social networks for patient health and well-being should be reinforced. More studies are needed to better understand the patient burden of NASH.