Patient-Reported Outcomes Measurement Information System Research Articles

Cancer-Related Cognitive Impairment Associated with APOE rs7412 and BDNF rs6265 in Breast Cancer Survivors

ObjectivesCancer-related cognitive impairment (CRCI) is a highly prevalent and debilitating symptom reported by breast cancer survivors (BCS). The etiology of CRCI remains unclear, leading to poor symptom management. Building from prior studies, BCS with the C/C genotype of apolipoprotein E (APOE) rs7412 and the T/T genotype of brain-derived neurotrophic factor (BDNF) rs6265 were hypothesized to experience more severe CRCI. Therefore, we investigated the relationships between the severity of CRCI and polymorphisms of APOE and BDNF among BCS. MethodsThis was a subanalysis of data from a larger descriptive, correlational, and cross-sectional study. Subjective and objective CRCI were measured using the Patient-Reported Outcomes Measurement Information System and CANTAB Cambridge Cognitive assessment, respectively. Buccal swab samples were collected to evaluate the single nucleotide polymorphisms. Multivariable generalized linear regression models were used to analyze data. ResultsAPOE rs7412 and BDNF rs6265 were significantly associated with lower self-reported cognitive abilities in a total of 353 BCS. Age was positively associated with self-reported cognitive scores, indicating that younger BCS perceived lower cognitive abilities. Individuals carrying genotype of C/T for APOE with the C/C or C/T for BDNF showed positive associations with cognitive abilities. ConclusionsYounger BCS with the C/C genotype for APOE rs7412 and the T/T genotype for BDNF rs6265 may be at risk for CRCI. Knowledge regarding predictive markers for CRCI symptoms is essential for precision symptom management. Further investigation with a longitudinal and translational design is necessary to explore the etiologies for CRCI. Implications for Nursing PracticeIntegrating genetic phenotyping into routine clinical practice will provide nurses with unique opportunities to understand individual susceptibilities, and how symptoms may trigger other symptoms. Further, findings from these innovative investigations will provide symptom interventionists and implementation scientists with critical data to optimize individualized strategies for symptom prevention, detection, and management.

Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators.

Chronic pain is a prevalent condition with enormous economic burden. Opioids such as tramadol, codeine, and hydrocodone are commonly used to treat chronic pain; these drugs are activated to more potent opioid receptor agonists by the hepatic CYP2D6 enzyme. Results from clinical studies and mechanistic understandings suggest that CYP2D6-guided therapy will improve pain control and reduce adverse drug events. However, CYP2D6 is rarely used in clinical practice due in part to the demand for additional clinical trial evidence. Thus, we designed the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) chronic pain study, a multicenter, pragmatic, randomized controlled clinical trial, to assess the effect of CYP2D6 testing on pain management. The study enrolled 1048 participants who are taking or being considered for treatment with CYP2D6-impacted opioids for their chronic pain. Participants were randomized to receive immediate or delayed (by 6 months) genotyping of CYP2D6 with clinical decision support (CDS). CDS encouraged the providers to follow the CYP2D6-guided trial recommendations. The primary study outcome is the 3-month absolute change in the composite pain intensity score assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Follow-up will be completed in July 2024. Herein, we describe the design of this trial along with challenges encountered during enrollment.

Utilization of patient reported outcomes measurement information system in plastic and reconstructive surgery research

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) was developed by investigators funded by the National Institutes of Health as a standardized means of directly assessing patients’ perspectives across domains. PROMIS domains include physical function, pain, fatigue, emotional distress, and social health. Various studies have reported increased utilization of PROMIS in research articles in specific specialties; however, the extent to which PROMIS has been employed in the field of plastic and reconstructive surgery remains unclear. The goal of the present study is to characterize the prevalence and trends of PROMIS within plastic and reconstructive surgery articles. MethodsLiterature search was conducted across multiple databases for PROMIS studies within plastic surgery literature. 136 were identified and the following data was extracted: author name, journal, impact factor, country of origin, year of publication, publication type, subspecialty, study size, and PROMIS measures used. Results136 studies met inclusion criteria. There was an overall increasing trend in the number of PROMIS studies published. The most common subspecialties that utilized PROMIS measures were General Reconstruction (n=24), Hand (n=9), and Burn (n=5). The most used PROMS measures were Pain Interference (n=26), Pain Intensity (n=15), and Depression (n=13). There was a total of 24 journals that included PROMIS studies with a mean impact factor of 3.73 (SD = 3.2). The most common country of origin was the United States (n=42). ConclusionThe data demonstrates an increasing use of PROMIS within plastic surgery across a wide variety of subspecialities and study designs. The characterization of these trends allows researchers and clinicians alike a greater understanding of a powerful tool in measuring patient care.

MCID achievement in staged bilateral total knee arthroplasty: Are both joints created equal?

BackgroundA notable portion of unilateral total knee arthroplasty (TKA) patients undergo arthroplasty of the contralateral knee. The aims of this study were to describe the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in staged bilateral TKAs (BTKAs) and identify factors associated with these outcomes. MethodsPatients with staged BTKA were retrospectively reviewed. Demographics, surgery details, and Patient-Reported Outcome Measurement Information System Physical Function Short Form 10a (PROMIS PF10a) were collected. MCID-I and MCID-W were defined for PROMIS PF10a. Patients were stratified into nine groups based on the MCID achievement of the first and second TKA: (A) MCID-I, MCID- I, (B) MCID-I, Neutral, (C) MCID-I, MCID-W, (D) Neutral, MCID-I, (E) Neutral, Neutral, (F) Neutral, MCID-W, (G) MCID- W, MCID-I, (H) MCID-W, Neutral, (I) MCID-W, MCID-W. Neutral patients did not achieve either MCID-I or MCID-W. ResultsThe final cohort consisted of 59 staged BTKA patients. In patients who achieved MCID-I in the first TKA, 39.1% achieved MCID-I again in the second TKA (A), 39.1% were neutral (B), and 21.7% achieved MCID-W (C) in the second TKA. However, 77.8% of those who achieved MCID-W in the first joint (n = 9) went on to achieve MCID-I (G) in the second TKA. Those who achieved MCID-I after both TKAs (A) had a longer staged interval than those who achieved first MCID-I, then MCID-W (C) (15 months vs 8 months, P = 0.0113). ConclusionIn staged BTKA, MCID achievement of the first TKA may not be associated with the outcome of the second TKA.

Measurement invariance of the PROMIS emotional distress and subjective well-being domains among autistic and General Population adolescents.

Quality of life (QoL) is identified as a clinical and research priority by the autistic community. Researchers have the responsibility to ensure that instruments used to measure QoL do so reliably and accurately among autistic participants. Our study evaluated measurement invariance of Emotional Distress (Depression, Anxiety, Anger, Psychological Stress) and Subjective Well-Being (Life Satisfaction, Positive Affect, and Meaning & Purpose) scales of the Patient-Reported Outcomes Measurement Information System (PROMIS) among groups of autistic (N=140, n per scale=132-140) and general population (N=1,224, n per scale=406-411) teenagers (14-17 years). These scales were included in the PROMIS Autism Battery-Lifespan, which uses PROMIS scales to measure QoL domains most relevant for autistic people. Multi-group confirmatory factor analyses using permutation tests demonstrated that Depression and Positive Affect scales exhibited scalar invariance between groups, indicating that scores can be meaningfully compared across autistic and general population teens. Anger and Psychological Stress scales demonstrated metric invariance between groups, indicating that these scales measure the same latent trait in both groups, but group comparisons are not supported. We provide guidance as to how these scales can be used in psychometrically supported ways to capture constructs relevant for understanding QoL among autistic teens.

Comparison of Time and Rate of Achieving Minimal Clinically Important Difference: Robotic Versus Manual Unicompartmental Knee Arthroplasty.

Robotics in unicompartmental knee arthroplasty (UKA) continues to increase with the ever-growing demand to use technology in the surgical setting. However, no studies have used minimal clinically important difference (MCID) to compare patient-reported outcome measures (PROMs) between robotic UKA (rUKA) and manual UKA (mUKA). This study aimed to compare the rate of achieving MCID for improvement (MCID-I) and worsening (MCID-W) and the time to achieving MCID. We conducted a retrospective analysis of robotic and manual UKAs performed between 2016 and 2022. Preoperative and postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical, PROMIS Physical Function Short-Form 10a (PF-10a), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short-Form (KOOS-PS) scores were collected. Patients were stratified on reaching MCID-I, MCID-W, or "no notable change" (score between MCID-W and MCID-I). Survival curves with and without interval censoring were used to assess the time to achieving the MCID. Log-rank and weighted log-rank tests were used to compare groups. A total of 256 UKAs (64 robotic and 192 manual) were analyzed. No differences were observed in the proportion of patients achieving MCID-I or MCID-W across all three PROMs. Similarly, median time to achieving MCID showed no significant differences between rUKA and mUKA for PROMIS Global Physical (3.3 versus 4.9 months, P = 0.44), PROMIS PF-10a (7.7 versus 8.3 months, P = 0.93), and KOOS-PS (3.0 versus 6.0 months, P = 0.055) scores, both with and without interval censoring. This study indicates that rUKA and mUKA exhibit comparable rates of achieving MCID-I and MCID-W, along with similar median time to reach MCID. These findings offer valuable patient-centric insights into the effectiveness of rUKA. Additional studies evaluating the long-term outcomes of rUKA are needed to determine its long-term advantages. Level III, retrospective comparative study.

The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration

In the CONVINCE trial, the primary analysis demonstrated a survival benefit for patients receiving high-dose hemodiafiltration (HDF) as compared with high-flux hemodialysis (HD). A secondary objective was to evaluate effects on health-related quality of life (HRQoL); assessed in eight domains (physical function, cognitive function, fatigue, sleep disturbance, anxiety, depression, pain interference, social participation) applying instruments from the Patient-Reported Outcome Measurement Information System (PROMIS) before randomization and every three months thereafter. In total 1360 adults with dialysis-dependent chronic kidney disease, eligible to receive high-flux HDF (23 liters or more), were randomized (1:1); 84% response rate to all questionnaires. Both groups reported a continuous deterioration in all HRQoL domains. Overall, raw score changes from baseline were more favorable in the HDF group, resulting in a significant omnibus test after a median observation period of 30 months. Most relevant single raw score differences were reported for cognitive function. Patients receiving HDF reported a decline of -0.95 units (95% confidence interval - 2.23 to +0.34) whereas HD treated patients declined by -3.90 units (-5.28 to - 2.52). A joint model, adjusted for mortality differences, utilizing all quarterly assessments, identified a significantly slower HRQoL decline in physical function, cognitive function, pain interference, and social participation for the HDF group. Their physical health summary score declined -0.46 units/year slower compared to the HD group. Thus, the CONVINCE trial showed a beneficial effect of high-dose hemodiafiltration for survival as well as a moderate positive effect on patients’ quality of life, most pronounced with respect to their cognitive function.

Association between work productivity and characteristics of adults with X-linked hypophosphatemia: an analysis of the XLH disease monitoring program.

X-linked hypophosphatemia (XLH) is a rare, genetic, progressive, phosphate-wasting disorder that causes skeletal morbidities, stiffness, pain, and impaired physical function. This study used baseline data from the XLH Disease Monitoring Program to evaluate relationships between work productivity and patient characteristics (demographics, medical history, patient-reported, and functional outcomes) in adults with XLH. Bivariate analysis guided the selection of variables for multivariate analysis after adjustment for multicollinearity and conceptual overlap. The analysis comprised 281 subjects (75.4% female; 80.8% from USA; median age 39.2yr); 53.4% were employed full-time and 31.3% were not employed; 15.3% were receiving disability payments; 47.0% were taking burosumab at study entry. Most employed subjects were working full-time outside the home (69.9%) and in light or sedentary roles (59.6%). In multivariate analyses, patients with fewer orthopedic surgeries (odds ratio [OR] 0.88; 95% confidence interval [CI], 0.81-0.96; p=.002) and better Patient-Reported Outcomes Measurement Information System Physical Function scores (OR 1.08; 95% CI, 1.02-1.15; p=.013) were more likely to be in full-time employment than not employed. Younger patients (OR 0.97; 95% CI, 0.94-0.99; p=.014) and those with fewer orthopedic surgeries (OR 0.83; 95% CI, 0.73-0.95; p=.008) were more likely to be in medium than light or sedentary work. Those with worse WOMAC Pain scores were more likely to be doing heavy/very heavy than light or sedentary activity (OR 1.04; 95% CI, 1.01-1.07; p=.006). Full-time employment levels are low in adults of working age with XLH, and unemployment and disability payment rates are high, suggesting that XLH has a substantial impact on work productivity. Worse physical function and a greater number of orthopedic surgeries are associated with lower work productivity. Worse pain, higher number of orthopedic surgeries, and younger age are associated with heavier work roles; however, causality was not specifically investigated.

Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial

Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99]). In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients. European Union Horizon 2020 Research and Innovation Programme.

Psychometric validation of the Patient-Reported Outcomes Measurement Information System Global Health Scale for people with multiple sclerosis.

The coronavirus disease 2019 pandemic and postpandemic era have significantly impacted the physical, mental, and social health (global health) of people with multiple sclerosis (MS). Extensive evidence highlights the positive relationships among global health, employment, and subjective well-being. For rehabilitation psychologists and health professionals serving individuals with MS, it is crucial to incorporate a global health measure into their assessment toolkit. The Patient-Reported Outcomes Measurement Information System Global Health (PROMIS©GH) Scale is widely used and validated for diverse patient populations worldwide. However, there is no study that validates the PROMIS©GH for people with MS. We conducted an exploratory factor analysis with a sample of U.S. adults with MS (N = 495) to examine the measurement structure of the PROMIS©GH. Exploratory factor analysis results indicated a two-factor measurement structure (physical health and mental-social health) that accounted for 67.80% of the total variance. All items loaded highly onto their respective factors (ranging from 0.59 to 0.93). The Cronbach's α of the two subscales was .85 and .86, which is high for very brief measures. The two factors were significantly and positively associated with employment, subjective well-being, resilience, core self-evaluations, and social support, and negatively associated with stress and depression in the theoretically expected directions, supporting its construct validity. The findings of this study indicated that PROMIS©GH is a psychometrically sound global health measure for people with MS and should be included as a health assessment tool for rehabilitation psychologists and health professionals who provide services to people with MS. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

A history of abuse is associated with more severe migraine- and pain-related disability: Results from the American Registry for Migraine Research.

Prior studies have established an association between a history of abuse and more severe migraine presentation. This cross-sectional, observational study of a clinic-based migraine population used validated measures to elucidate migraine-specific and migraine-related burdens among patients with a history of abuse. Patients with migraine (n = 866) from the American Registry for Migraine Research self-reported if they had a history of emotional, physical, and/or sexual abuse and completed questionnaires assessing migraine-related burden: Migraine Disability Assessment, Subjective Cognitive Impairment Scale for Migraine Attacks, Work Productivity and Activity Impairment, Patient-Reported Outcomes Measurement Information System Pain Interference, Patient Health Questionnaire-2, and Generalized Anxiety Disorder-7. Migraine-related burden in patients with versus without a history of abuse was compared. Subsequently, a mediation analysis evaluated the impact of depression and anxiety symptoms in the relationship between abuse history and migraine burden. A history of abuse was reported by 36.5% (n = 316/866) of participants. After controlling for patient age, sex, years lived with headache, and headache frequency, a history of abuse was significantly associated with more severe migraine-related disability. The combined burden of depression and anxiety symptoms mediated the relationship. A history of abuse is associated with greater migraine-related disability. Future studies should determine if identification and management of the psychological and physical sequelae of abuse reduce migraine burden.

Worse postoperative outcomes and higher reoperation in smokers compared to nonsmokers for arthroscopic rotator cuff repair

Background This study aimed to determine if smokers at the time of arthroscopic rotator cuff repair met the minimally clinical important difference and substantial clinical benefit for Patient-Reported Outcomes Measurement Information System Upper Extremity, Depression, and Pain Interference scores in comparison to nonsmoking patients in a retrospective review. Methods Clinical outcomes and Patient-Reported Outcomes Measurement Information System scores were compared between a cohort of nonsmokers and current or former smokers (smokers). Further sub-analysis compared a cohort of nonsmokers propensity-matched 1:1 to a cohort of current/former smokers via age, body mass index, and tear size. Results A total of 182 patients, 80 smokers and 102 nonsmokers, were included. Smokers had statistically different-sized tears with more rated massive ( P = 0.02) and more reoperations ( P = 0.02). Smokers met substantial clinical benefit thresholds at a lower rate than nonsmokers for Patient-Reported Outcomes Measurement Information System Upper Extremity ( P = 0.03). In the sub-analysis, 74 smokers were matched to 74 nonsmokers. Smokers had a lower change in Patient-Reported Outcomes Measurement Information System Upper Extremity ( P = 0.007) and Patient-Reported Outcomes Measurement Information System Pain Interference ( P = 0.03) postoperatively. Fewer smokers met minimally clinical important difference for Patient-Reported Outcomes Measurement Information System Upper Extremity postoperatively ( P = 0.003) and more had reoperations ( P = 0.02). Discussion Overall, smokers demonstrated smaller improvements in function, and pain, and were less likely to meet minimally clinical important differences and substantial clinical benefits for Patient-Reported Outcomes Measurement Information System Upper Extremity at 6 months follow-up when compared to nonsmokers after rotator cuff repair.

Can Patient-Reported Outcomes Measurement Information System estimate high-impact chronic pain after total shoulder arthroplasty?

Can Patient-Reported Outcomes Measurement Information System estimate high-impact chronic pain after total shoulder arthroplasty?

Long-term efficacy, safety, and patient-reported outcomes of apitegromab in patients with spinal muscular atrophy: results from the 36-month TOPAZ study.

At 12 months in the phase 2 TOPAZ study, treatment with apitegromab was associated with both an improved motor function in patients with Type 2 or 3 spinal muscular atrophy (SMA) and with a favorable safety profile. This manuscript reports the extended efficacy and safety in the nonambulatory group of the TOPAZ study at 36 months. Patients who completed the primary study (NCT03921528) could enroll in an open-label extension, during which patients received apitegromab 20 mg/kg by intravenous infusion every 4 weeks. Patients were assessed periodically via the Hammersmith Functional Motor Scale-Expanded (HFMSE), Revised Upper Limb Module (RULM), World Health Organization (WHO) motor development milestones, Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Daily Activities and Mobility domains, and Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire. Of the 58 patients enrolled in TOPAZ, 35 were nonambulatory (mean age 7.3 years). The mean change at 36 months in HFMSE score from baseline was +4.0 (standard deviation [SD]: 7.54), and + 2.4 (3.24) for RULM score (excluding n = 7 after scoliosis surgery). Caregiver-reported outcomes (PEDI-CAT and PROMIS Fatigue) showed improvements from baseline over 36 months. In addition, most patients (28/32) improved or maintained WHO motor milestones achieved at baseline. The most frequently reported treatment-emergent adverse events were pyrexia (48.6%), nasopharyngitis (45.7%), COVID-19 infection (40.0%), vomiting (40.0%), and upper respiratory tract infection (31.4%). The benefit of apitegromab treatment observed at 12 months was sustained at 36 months with no new safety findings.

Comparison of the EQ-5D-5L and the patient-reported outcomes measurement information system preference score (PROPr) in the United States

BackgroundIn contrast to prior research, our study presents longitudinal comparisons of the EQ-5D-5L and Patient-Reported Outcomes Measurement Information System (PROMIS) preference (PROPr) scores. This fills a gap in the literature, providing a much-needed understanding of these preference-based measures and their applications in healthcare research. Furthermore, our study provides equations to estimate one measure from the other, a tool that can significantly facilitate comparisons across studies.MethodsWe administered a health survey to 4,098 KnowledgePanel® members living in the United States. A subset of 1,256 (82% response rate) with back pain also completed the six-month follow-up survey. We then conducted thorough cross-sectional and longitudinal analyses of the two measures, including product-moment correlations between scores, associations with demographic variables, and health conditions. To estimate one measure from the other, we used ordinary least squares (OLS) regression with the baseline data from the general population.ResultsThe correlation between the EQ-5D-5L and PROPr scores was 0.69, but the intraclass correlation was only 0.34 because the PROPr had lower (less positive) mean scores on the 0 (dead) to 1 (perfect health) continuum than the EQ-5D-5L. The associations between the two preference measures and demographic variables were similar at baseline. The product-moment correlation between unstandardized beta coefficients for each preference measure regressed on 22 health conditions was 0.86, reflecting similar patterns of unique associations. Correlations of change from baseline to 6 months in the two measures with retrospective perceptions of change were similar. Adjusted variance explained in OLS regressions predicting one measure from the other was 48%. On average, the predicted values were within a half-standard deviation of the observed EQ-5D-5L and PROPr scores. The beta-binomial regression model slightly improved over the OLS model in predicting the EQ-5D-5L from the PROPr but was equivalent to the OLS model in predicting the PROPr.ConclusionDespite substantial mean differences, the EQ-5D-5L and PROPr have similar cross-sectional and longitudinal associations with other variables. We provide the OLS regression equations for use in cost-effectiveness research and meta-analyses. Future studies are needed to compare these measures with different conditions and interventions to provide more information on their relative validity.

Smoking cessation prior to elective total joint arthroplasty results in sustained abstinence postoperatively.

Tobacco use is a well-documented modifiable risk factor for perioperative complications. To determine the tobacco abstinence rates of patients who made cessation efforts prior to a total joint arthroplasty (TJA) procedure. A retrospective evaluation was performed on 88 self-reported tobacco users who underwent TJA between 2014-2022 and had tobacco cessation dates within 3 mo of surgery. Eligible patients were contacted via phone survey to understand their tobacco use pattern, and patient reported outcomes. A total of 37 TJA patients participated. Our cohort was on average 61-years-old, 60% (n = 22) women, with an average body mass index of 30 kg/m2. The average follow-up time was 2.9 ± 1.9 years. A total of 73.0% (n = 27) of patients endorsed complete abstinence from tobacco use prior to surgery. Various cessation methods were used perioperatively including prescription therapy (13.5%), over the counter nicotine replacement (18.9%), cessation programs (5.4%). At final follow up, 43.2% (n = 16) of prior tobacco smokers reported complete abstinence. Patients who were able to maintain cessation postoperatively had improved Patient-Reported Outcomes Measurement Information System (PROMIS)-10 mental health scores (49 vs 58; P = 0.01), and hip dysfunction and osteoarthritis outcome score for joint replacement (HOOS. JR) scores (63 vs 82; P = 0.02). No patients in this cohort had a prosthetic joint infection or required revision surgery. We report a tobacco cessation rate of 43.2% in patients undergoing elective TJA nearly 3 years postoperatively. Patients undergoing TJA who were able to remain abstinent had improved PROMIS-10 mental health scores and HOOS. JR scores. The perioperative period provides clinicians a unique opportunity to assist active tobacco smokers with cessation efforts and improve postoperative outcomes.

Cladribine effects on patient-reported outcomes and their clinical and biometric correlates in highly active relapsing multiple sclerosis at first switch: the observational, multicenter, prospective, phase IV CLADFIT-MS study.

Patient-reported outcomes (PROs) are essential for understanding the effects of MS and its treatments on patients' lives; they play an important role in multiple sclerosis (MS) research and practice. We present the protocol for an observational study to prospectively assess the effect of cladribine tablets on PROs and their correlation to disability and physical activity in adults with highly active relapsing MS switching from a first disease modifying drug (DMD) to cladribine tablets in routine clinical practice at study sites in Italy. The primary objective will be to evaluate changes from baseline in the impact of highly active MS on self-assessed physical functioning 52 weeks after the switch to cladribine tablets using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary objectives will include self-assessed psychological impact of highly active MS in daily life and general health after the switch to cladribine tablets as well as changes in cognitive function, anxiety, and depression symptoms. Additional PRO measures will include the Hospital Anxiety and Depression Scale (HADS), the EuroQoL 5-Dimension 5-Level (EQ-5D-5L), the Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), and the Patient-Reported Outcomes Measurement Information System (PROMIS). Wearable devices will acquire activity data (step counts, walking speed, time asleep, and energy expenditure). Additional clinical, radiological, and laboratory data will be collected when available during routine management. The findings will complement data from controlled trials by providing insight from daily clinical practice into the effect of cladribine tablets on the patient's experience and self-assessed impact of treatment on daily life.

Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial.

To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. Multicentre non-inferiority randomised controlled trial. Five teaching hospitals and two university hospitals in the Netherlands. Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.

Electronic Patient-Reported Outcome-Driven Symptom Management by Oncology Pharmacists in a Majority-Minority Population: An Implementation Study.

There is a lack of systematic solutions to manage supportive care issues in racial/ethnic minorities (REM) receiving treatment for cancer. We developed and implemented an electronic patient-reported outcome (ePRO)-driven symptom management tool led by oncology pharmacists in a majority-minority cancer center located in Southern California. This study was designed to evaluate the implementation outcomes of our multilevel intervention. This was a prospective, pragmatic, implementation study conducted between July 2021 and June 2023. Newly diagnosed adult patients with cancer receiving intravenous anticancer therapies completed symptom screening using ePRO that consists of the Patient-Reported Outcomes Measurement Information System measures at each infusion visit during the study. ePRO results were presented to an oncologist pharmacist for personalized symptom management and treatment counseling. The RE-AIM framework was used to guide implementation outcomes. Differences in symptom trajectories and clinical outcomes between groups were tested using generalized estimating equations. We screened 388 patients of whom 250 were enrolled (acceptance rate: 64.4%), with 564 assessments being completed. The sample consisted of non-Hispanic White (NHW, 42.4%), Hispanic/Latinx (H/L, 30.8%), and non-Hispanic Asian (20.4%), with one (21.6%) of five participants preferring speaking Spanish. Compared with NHW, H/L participants had greater odds of reporting mild to severe pain interference (odds ratio [OR], 1.91 [95% CI, 1.18 to 3.08]; P = .008) and nausea and vomiting (OR, 2.08 [95% CI, 1.21 to 3.58]; P = .008), and higher rates of urgent care utilization (OR, 1.92 [95% CI, 1.04 to 3.61]; P = .04) within 30 days. Nausea and vomiting (n = 131, 23.2%), pain (n = 91, 16.1%), and fatigue (n = 72, 12.8%) were most likely to be intervened, with 90% of the participants expressing satisfaction across all visits. Our multilevel ePRO-driven intervention led by oncology pharmacists helps facilitate symptom assessments and management and potentially reduce health disparities among REM.

Social Vulnerability Index Provides Greater Granularity Compared to the Area Deprivation Index When Assessing Outcomes Following Elective Lumbar Fusion.

Retrospective review of a single institution cohort. To determine whether Area Deprivation Index (ADI) or Social Vulnerability Index (SVI) is more suitable for evaluating minimum clinically important difference (MCID) achievement following elective lumbar fusion as captured by the Patient Reported Outcomes Measurement Information System (PROMIS). A total of 182 patients who underwent elective one- to two-level posterior lumbar fusion between January 2015 and September 2021. ADI and SVI values were calculated from patient-supplied addresses. Patients were grouped into quartiles based on values; higher quartiles represented greater disadvantage. MCID thresholds for Pain Interference (PI) and Physical Function (PF) were determined via a distribution-based method. Multivariable logistic regression was performed to identify factors impacting MCID attainment. Univariate logistic regression was performed to determine which themes comprising SVI values affected MCID achievement. Statistical significance was set at P<0.05. Multivariate logistic regression demonstrated that ADI and SVI quartile assignment significantly impacted achievement of MCID for PI (P=0.04 and P=0.01 respectively) and PF (P=0.03 and P=0.02 respectively). Specifically, assignment to the third ADI and SVI quartiles were significant for PI (OR: 0.39 and 0.23 respectively), and PF (OR: 0.24 and 0.22 respectively). Race was not a significant predictor of MCID for either PI or PF. Univariate logistic regression demonstrated that among SVI themes, the socioeconomic status theme significantly affected achievement of MCID for PI (P=0.01), while the housing type and transportation theme significantly affected achievement of MCID for PF (P=0.01). ADI and SVI quartile assignment were predictors of MCID achievement. While ADI and SVI may both identify patients at risk for adverse outcomes following lumbar fusion, SVI offers greater granularity in terms of isolating themes of disadvantage impacting MCID achievement.