SF-36v2 Physical Component Summary Research Articles

Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): prespecified analysis of the phase III ustekinumab trial in patients with SLE

ObjectiveThe Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) system is a novel and simple SLE disease activity instrument, consisting of a tandem clinician-reported (ClinRO) and patient-reported...

Patient-Reported Outcomes in Long-Term Survivors of Autologous Hematopoietic Cell Transplantation in Multiple Myeloma

The overall survival in patients with transplantation-eligible multiple myeloma has tripled over the past 2 decades, leading to a growing population of myeloma survivors. However, there is a paucity of data on health-related quality of life (HRQoL), distress, and health behaviors in long-term myeloma survivors who are in stable remission after autologous hematopoietic cell transplantation (AHCT). In this cross-sectional study using data from 2 randomized controlled trials of survivorship care plans and internet-based self-management intervention in transplantation survivors, the primary objective was to measure HRQoL (using the Short Form-12, version 2.0 [SF-12 v2]), distress (using the Cancer- and Treatment-Related Distress [CTXD] instrument), and health behaviors of myeloma survivors in stable remission after AHCT. A total of 345 patients at a median of 4 years (range, 1.4 to 11 years) post-AHCT were included. The mean SF-12 v2 Physical Component Summary (PCS) score was 45.5 ± 10.5, and the mean Mental Component Summary (MCS) score was 51.3 ± 10.1, compared with US population norms of 50 ± 10 for both (P < .001 and P=.021 for PCS and MCS comparisons, respectively). Notably, neither reached the threshold for a minimal clinically important difference. Approximately one-third of the patients had clinically significant distress based on the CTXD total score, with distress reported by 53% of the patients in the Health Burden domain, by 46% in the Uncertainty domain, by 33% in the Finances domain, by 31% in the Family Strain domain, by 21% in the Identity domain, and by 15% in the Medical Demands domain. Preventive care guidelines were adhered to by 81% of the myeloma survivors; however, adherence to exercise and diet guidelines were relatively low, at 33% and 13%, respectively. Myeloma AHCT survivors in stable remission have no clinically meaningful worsening in physical functioning compared with the general population. Survivorship programs should address ongoing distress due to health burden, uncertainty, and finances in myeloma survivors, along with evidence-based targeted interventions for modifiable health behaviors, such as nutrition and exercise.

Physical function, nutritional status, and quality of life before and after chemotherapy in patients with malignant lymphoma.

This study investigates the efficacy of and gender differences in exercise therapy in patients with malignant lymphoma undergoing chemotherapy. Twenty-six patients (13 men, 13 women) received physical therapy (based on the Borg Scale 13) during hospitalization. Physical function was measured using grip and knee extension strength, 6-minute walking distance, and body composition; nutritional status assessed via Mini Nutritional Assessment (MNA®); and serum albumin levels analyzed. Fatigue was evaluated using the Brief Fatigue Inventory, and health-related quality of life was assessed with the Medical Outcome Study 36-Item Short-Form Health Survey (SF-36v2). The analysis of all patients indicated that the right grip strength, skeletal muscle mass, skeletal muscle index, and leg muscle mass significantly decreased, whereas the serum albumin level, MNA® score, and scores of many items of the SF-36v2 significantly increased after chemotherapy. In a gender-specific analysis, only men showed significant declines in the skeletal muscle mass and skeletal muscle index, and improvement in the MNA® score after chemotherapy. In the SF-36v2, there were significant improvements in general health and physical component summary scores among men, and general health and mental component summary scores among women. Exercise therapy at a Borg Scale intensity of 13 may not prevent muscle mass decline in patients with malignant lymphoma, especially male patients. In addition, this study revealed that there is a gender difference in the effect of exercise therapy on quality of life. Thus, gender should be considered in exercise therapy for patients with malignant lymphoma.

Home therapies to improve disability, activity, and quality of life in military personnel with subacute low back pain: Secondary outcome analysis of a randomized controlled trial

BackgroundLow back pain (LBP) is an urgent military health concern with implications for fitness, quality of life (QoL) and disability. PurposeThis secondary outcome analysis from a randomized controlled trial (RCT) was to determine if the addition of neuromuscular electrical stimulation core strength training (NMES) or progressive exercise (PEP)in conjunction with primary care management (PCM) was more effective than PCM alone. MethodsThis randomized controlled trial (RCT assigned 128 service members to the three intervention groups. The outcomes included changes in perceived disability (Oswestry Disability Index), health-related quality of life (SF-12v2), pain during activity (Clinical Back Pain Questionnaire), and daily steps walked in service members with subacute LBP. FindingsOver a 9-week intervention, perceived disability, SF-12v2 physical component summary, and activity associated with pain improved in all groups. Home therapies were helpful to reduce perceived disability, QoL and pain during activity in service members with subacute LBP. DiscussionThese non-pharmacological options provide other home-managed approaches for those in the subacute LBP phase.

Long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy: Analysis of the open-label extension of the NEURO-TTR trial.

Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) progressively affects patients' functionality and compromises health-related quality of life (HRQL). The aim of this study was to quantify the projected long-term treatment effects of inotersen vs placebo on HRQL measures. The inotersen phase 2/3 randomized, double-blind, placebo-controlled trial NEURO-TTR (NCT01737398, 65 weeks) and its subsequent open-label extension (OLE; NCT02175004, 104 weeks) included 172 (112 inotersen and 60 placebo) patients. Placebo double-blind period and overall inotersen-inotersen (double-blind/OLE) treatment period (170 weeks) data were used to extrapolate the long-term placebo-placebo effect using mixed-effects models with repeated measures. Changes from baseline in the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) and 36-Item Short Form Health Survey version 2 (SF-36v2) in hATTR-PN were estimated. Differences in changes were compared between the inotersen-inotersen and extrapolated placebo-placebo arms. Inotersen-inotersen patients maintained their HRQL with an observed change ranging from 10.3% improvement (Norfolk QoL-DN item "Pain kept you awake at night") to 11.6% deterioration (SF-36v2 Activities of Daily Living subdomain). The extrapolated placebo-placebo results suggest greater deterioration over time compared with inotersen-inotersen treatment on Norfolk QoL-DN total score (23.6; 95% confidence interval [CI], 8.9-38.3; P < .01), Activities of Daily Living (4.6; 95% CI, 2.0-7.3; P < .001), and "Pain kept you awake at night" (1.2; 95% CI, 0.4-1.9; P < .01). Similarly, greater deterioration was expected for the SF-36v2 Physical Component Summary (8.0; 95% CI, 3.2-12.8, P < .01), Bodily Pain (7.8; 95% CI, 2.0-13.5; P < .01), and Physical Functioning (10.6; 95% CI, 5.5-15.6; P < .0001). Long-term (>3 years) inotersen treatment was associated with slowing and, in some domains, halting of deterioration in key HRQL outcome measures, particularly physical functioning and pain.

Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebo-controlled trial

BackgroundAnkylosing spondylitis (AS) impacts quality of life. We assessed patient-reported outcomes (PROs), pain, fatigue, health-related quality of life (HRQoL) and work productivity in a phase III trial of tofacitinib.MethodsAdults with...

Correlations Between Physical Activity Level, Quality of Life, and Cognitive Performance in Elderly Individuals Engaging in Multi-Year Dance Activities.

It is well-acknowledged that cognitive and physical decline associated with aging can be prevented or reduced with the engagement in regular physical activity (PA). Dance activities combine cardiovascular, cognitive, and coordinative demands, providing a popular leisure PA among elderly. This study examined the correlations between quality of life (QoL), cognitive and physical performance, and PA level in older adults who participated in at least 10 years of amateur ballroom dancing. <br/>Methods: The study was designed as an observational study. A sample of 20 (10 men; age range: 65 to 80 years; BMI: 26.3 ± 3.0 kg/m²) amateur senior dancers were compared with a sample of 18 (8 men; age range: 65 to 75 years; BMI: 25.5 ± 2.4 kg/m²) non-sedentary individuals (control group) following an adapted PA program. Quality of life and cognitive functioning assessment tools were administered: 36 Health Status Survey (SF-36v2), Montreal Cognitive Assessment (MoCA), and Cognitive Reserve Index questionnaire (CRIq). Physical performance was measured with their preferred walking speed (PWS), and level of moderate to vigorous physical activity (MVPA) was evaluated using a multi-sensor activity monitor. <br/>Results: Participants presented a good SF-36v2 physical component and a very good mental com- ponent summary, a total MoCA score within the limits, and an average total CRIq score. Their PWS and daily MVPA were high. Differences neither in the three questionnaires nor in PWS and PA level were observed between groups. A significant, moderate, and positive correlation was found between PWS and SF-36v2 physical component summary score. <br/>Conclusion: Ballroom dancing seems to allow elderly individuals to maintain good cognitive and physical abilities, QoL, an acceptable normal cognitive reserve, notable physical performance, and PA level to the same extent as an adapted PA program. Both types of PA seem to be able to contrast the mental and physical decline associated with aging.

Early Mental Health and Quality of Life in Discharged Patients With COVID-19.

Aim: This study aimed to analyze the early mental health (MH) and quality of life (QoL) of discharged patients with coronavirus disease 2019 (COVID-19), which can provide a scientific basis for the further development of intervention programs.Methods: In total, 108 subjects participated in this study, including an experimental group (90 patients diagnosed with COVID-19 from March to April 2020 and hospitalized in Wuhan China Resources & WISCO General Hospital, Wuhan, China, 83.3%) and a control group (18 healthy participants, 16.7%). Their MH and QoL were measured through the 12-item Short Form Health Survey version 2 (SF-12v2), the Self-rating anxiety scale (SAS), the Self-rating depression scale (SDS), and the International Physical Activity Questionnaire (IPAQ). The results of questionnaires were compared between these two groups.Results: (1) Comparison of anxiety status: among 90 discharged patients with COVID-19, 30 patients (33.3%) had a state of anxiety. Compared with healthy participants and the general population, patients with COVID-19 in the early stages of discharge had a higher incidence of anxiety and more severe anxiety symptoms (P < 0.05). (2) Comparison of depression status: among 90 discharged patients with COVID-19, 29 patients (32.2%) had a state of depression. Compared with healthy participants and the general population, patients with COVID-19 in the early stages of discharge had a higher incidence of depression and more severe depression symptoms (P < 0.05). (3) Comparison of QoL: 78 patients (86.7%) presented a decrease in physical health-related quality of life (HRQoL) and 73 patients (81.1%) presented a decrease in psychology-related QoL. The SF-12v2 physical component summary (PCS) and the SF-12v2 mental component summary (MCS) of patients were significantly lower than those of healthy people, especially in physical function (PF), vitality (VT), social function (SF), and mental health (MH) (all P < 0.05). (4) Gender differences in mental health and the QoL among patients with COVID-19: women had more severe anxiety/depression symptoms than men (P < 0.05). The scores of women in all dimensions of SF-12V2 were lower than those of men, and there were statistically significant differences between the two groups in PCS, PF, general health (GH), VT, and role-emotional (RE) (P < 0.05).Conclusion: During the early phase after being discharged, patients with COVID-19 might experience negative emotions, such as anxiety or depression, and also problems with reduced QoL, especially among female patients. Therefore, an intervention plan should focus on strengthening psychological condition and improving physical function, and gender-specific rehabilitation programmes should be adapted to improve psychological status and QoL.

Burden of chronic low back pain: Association with pain severity and prescription medication use in five large European countries.

ObjectiveThis study assessed associations between severity of, and prescription medication use for, chronic low back pain (CLBP) and health‐related quality of life, health status, work productivity, and healthcare resource utilization.MethodsThis cross‐sectional study utilized SF‐12, EQ‐5D‐5L, and work productivity and activity impairment (WPAI) questionnaires, and visits to healthcare providers among adults with self‐reported CLBP participating in the National Health and Wellness Survey in Germany, France, UK, Italy, and Spain. Respondents were stratified into four groups according to pain severity (mild or moderate/severe) and prescription medication use (Rx‐treated or Rx‐untreated). Differences between groups were estimated using generalized linear models controlling for sociodemographics and health characteristics.ResultsOf 2086 respondents with CLBP, 683 had mild pain (276 Rx‐untreated, 407 Rx‐treated) and 1403 had moderate/severe pain (781 Rx‐untreated, 622 Rx‐treated). Respondents with moderate/severe pain had significantly worse health‐related quality of life (SF‐12v2 physical component summary), health status (EQ‐5D‐5L), and both absenteeism and presenteeism compared with those with mild pain, including Rx‐untreated (moderate/severe pain Rx‐untreated vs. mild pain Rx‐untreated, p ≤ 0.05) and Rx‐treated (moderate/severe pain Rx‐treated vs. mild pain Rx‐treated, p ≤ 0.05) groups. Significantly more visits to healthcare providers in the last 6 months were reported for moderate/severe pain compared with mild pain for Rx‐treated (least squares mean 13.01 vs. 10.93, p = 0.012) but not Rx‐untreated (8.72 vs. 7.61, p = 0.072) groups. Health‐related quality of life (SF‐12v2 physical component summary) and health status (EQ‐5D‐5L), as well as absenteeism and presenteeism, were significantly worse, and healthcare utilization was significantly higher, in the moderate/severe pain Rx‐treated group compared with all other groups (all p ≤ 0.05).ConclusionGreater severity of CLBP was associated with worse health‐related quality of life, health status, and absenteeism and presenteeism, irrespective of prescription medication use. Greater severity of CLBP was associated with increased healthcare utilization in prescription medication users.

Luspatercept Improves Quality of Life and Reduces Red Blood Cell Transfusion Burden in Patients with Non-Transfusion-Dependent β-Thalassemia in the BEYOND Trial

Luspatercept Improves Quality of Life and Reduces Red Blood Cell Transfusion Burden in Patients with Non-Transfusion-Dependent β-Thalassemia in the BEYOND Trial

POS0895 EFFECT OF TOFACITINIB ON PATIENT-REPORTED OUTCOMES IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS FROM A PHASE 3 TRIAL

Background:Ankylosing spondylitis (AS) can significantly impact quality of life. Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of adult patients (pts) with AS. The safety/efficacy (including pt-reported outcomes [PROs]) of tofacitinib in pts with AS was assessed in a Phase 3 trial (NCT03502616).1Objectives:To evaluate the effect of tofacitinib on pt-reported pain, fatigue, overall health and work productivity in pts with active AS enrolled in the Phase 3 trial.Methods:Pts with an inadequate clinical response or intolerance to ≥2 oral NSAIDs were randomised in a double-blind fashion to tofacitinib 5 mg twice daily (BID) or placebo (PBO) for 16 weeks. At Week (W)16, all pts received open-label tofacitinib 5 mg BID up to W48. Least squares (LS) mean changes from baseline (Δ) up to W48 are reported for the following outcomes: pt assessment of nocturnal spinal pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form-36 Health Survey version 2 (SF-36v2; W16 and W48 only), and Work Productivity and Activity Impairment Questionnaire (WPAI; W16 and W48 only).Results:At W16, there were greater improvements from baseline in pain (total back pain [previously published1] and nocturnal spinal pain) and fatigue (FACIT-F total score; experience and impact domain scores) with tofacitinib vs PBO (p≤0.05; Table 1); improvements were observed as early as W2. Also, improvements in SF-36v2 physical component summary (PCS) (Table 1), and physical functioning, role-physical, bodily pain, general health and social functioning domains (Figure 1) were greater with tofacitinib vs PBO at W16 (p≤0.05). Similarly, improvements in WPAI scores at W16 were greater with tofacitinib vs PBO (p≤0.05), except for % work time missed (Table 1). Improvements with tofacitinib continued up to W48 (Table 1/Figure 1). Generally, pts receiving PBO who advanced to tofacitinib at W16 reported similar improvements after switching to tofacitinib (Table 1/Figure 1).Table 1.PROs at baseline and Δ at W16 and W48Baseline,mean (SD) [N1]Δ, W16,LS mean (SE)Δ, W48,LS mean (SE)Tofacitinib5 mg BID (N=133)PBO(N=136)Tofacitinib5 mg BIDPBOp valueTofacitinib5 mg BIDPBO→tofacitinib5 mg BIDNocturnalspinal paina6.8 (1.9)6.8 (1.9)-2.67 (0.20)-0.84 (0.20)&lt;0.0001-3.52 (0.23)-3.01 (0.23)FACIT-Ftotal scorea,b27.2 (10.7)27.4 (9.3)6.54 (0.80)3.12 (0.79)0.00089.54 (0.90)7.35 (0.89)FACIT-F experience domaina8.9 (4.3)8.7 (4.0)2.85 (0.36)1.29 (0.36)0.00074.22 (0.40)3.40 (0.40)FACIT-Fimpactdomaina18.3 (6.9)18.8 (5.9)3.68 (0.49)1.81 (0.49)0.00285.32 (0.54)3.95 (0.54)SF-36v2 PCSb,c33.5 (7.3)33.1 (7.0) [135]6.69 (0.59)3.14 (0.59)&lt;0.00018.81 (0.720)7.39 (0.71)SF-36v2 MCSc39.4 (11.1)39.8 (12.7) [135]3.45 (0.91)2.13 (0.92)0.25297.07 (0.93)6.35 (0.92)WPAIc% activity impairment56.5 (23.4)56.0 (21.4)-19.03 (1.97)-5.63 (1.97)&lt;0.0001-27.37 (2.34)-19.77 (2.31)% work time missed9.9 (22.4) [81]11.5 (24.6) [88]-3.65 (2.66)0.88 (2.62)0.1784-8.10 (2.14)-5.79 (2.05)% impairment while working48.4 (26.3) [79]49.6 (22.2) [85]-19.83 (2.27)-6.94 (2.30)&lt;0.0001-25.35 (2.77)-23.00 (2.66)% overall work impairment50.8 (27.4) [79]53.5 (23.1) [85]-21.49 (2.51)-7.64 (2.56)&lt;0.0001-27.63 (3.01)-23.22 (2.90)aMMRMbGlobal type I error-controlled endpointcAnalysis of covariance model for W16 and MMRM for W48MCS, mental component summary; MMRM, Mixed Model for Repeated Measures; N, number of pts in full analysis set; N1, number of pts included in the analysis (if different from N); SD, standard deviation; SE, standard errorConclusion:In pts with active AS, improvements in spinal pain, fatigue, overall health and work productivity were greater with tofacitinib vs PBO at W16; improvements continued up to W48. These PRO findings support the primary efficacy results of this Phase 3 trial,1 and add to the overall understanding of the benefit/risk profile of tofacitinib in patients with AS.

Health-related quality of life, depression, anxiety and sexual dysfunction in patients with testicular cancer

Background and objective: Testicular cancer is one of the most common cancer types among young men. Although there is high percentage of cure rates for the patients, there is a lack of knowledge regarding health-related quality of life, psychological problems and sexual dysfunction. The aim of this study was to examine health-related quality of life, anxiety, depression and sexual dysfunction in patients with testicular cancer.Methods: Data were collected from 160 patients diagnosed with testicular cancer at age 20–60 years. The survey method was used to collect information.Results: The results showed that the mean scores of SF-12v2 physical component (p = 0.02), HADS-anxiety (p < 0.011) and HADS-depression (p = 0.01) were significantly different between marital status groups. The mean scores of IIEF-5 were significantly different between income groups (p = 0.01) and employment status (p = 0.02). Participants who earned low income, had primary or lower education, and were not employed reported significantly poorer erectile function than their higher earning, higher educated and employed counterparts. Also, HADS anxiety and HADS depression scores were found to be moderate and positively correlated with IIEF-5 (p < 0.01). However, SF-12v2 physical component summary and mental component summary scores were negatively correlated with IIEF-5 (p < 0.01).Conclusion: The current study findings provided knowledge on health-related quality of life, anxiety, depression and sexual dysfunction in patients with testicular cancer. Health-related quality of life, psychological mental health and sexual life were poorer among the participants.

Body image mediates the relationship between post-surgery needs and health-related quality of life among women with breast cancer: a cross-sectional study

BackgroundAlthough body image (BI) disturbance is a common problem that often contributes to poor health-related quality of life (HRQoL) among women with breast cancer following surgery, the mediating role of BI (as a self-perceptive factor) in the relationship between needs and HRQoL after controlling for socio-demographic factors remains unclear. The purpose of this study was to identify the mediating role of BI between post-surgery needs and HRQoL after controlling for socio-demographic factors among women with breast cancer.MethodsIn this cross-sectional study, the primary outcome was HRQoL (as measured with the 36-item Short-Form Health Survey version 2 [SF-36v2] and Functional Assessment of Cancer Therapy-Breast version 4.0 [FACT-Bv4.0]). The secondary outcomes included needs (measured in terms of needs importance [NI] and needs satisfaction [NS]) and BI. Structural equation modeling was used to identify the mediating role of BI between needs and HRQoL while considering socio-demographics.ResultsThe 406 eligible patients reported poor HRQoL, and approximately half reported important unmet needs and poor BI. NI, NS, and socio-demographics had differing direct effects on BI and HRQoL, and contrasting indirect effects on HRQoL via BI. NI, NS, surgery type, presence of chronic disease, and BI explained 4% of the variance in the SF-36v2 physical component summary score; NI, NS, surgery type, residence, and BI explained 20% of the variance in the mental component summary score; and NI, NS, marital status, employment status, radiotherapy, and BI explained 33% of the variance in the FACT-Bv4.0 total score.ConclusionsAfter surgery, women with breast cancer have poor HRQoL and BI, and important unmet needs. BI mediates the relationship between needs and HRQoL after controlling for socio-demographics. The present findings provide information for developing comprehensive BI-based needs interventions and preparing targeted health-management programs for patients with breast cancer.

Improvement in Quality of Life in Patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy and Cardiomyopathy Treated with Inotersen in the Phase 3 Study NEURO-TTR

Introduction Hereditary transthyretin (TTR) amyloidosis (hATTR) is a rare, progressive, and fatal disease. The disease is caused by misfolded TTR that builds up as amyloid in major organ systems, especially cardiac tissue and nerves, causing cardiomyopathy (CM) and polyneuropathy (PN), respectively. hATTR causes significant morbidity and a progressive decline in patient quality of life (QOL), severely limiting activities of daily living. Purpose To evaluate the effect of inotersen, an antisense oligonucleotide inhibitor of TTR protein production, on QOL of patients with hATTR with CM and PN. Methods NEURO-TTR (NCT01737398) is a global, randomised, double-blind, placebo-controlled phase 3 study. Adults (n=172) with hATTR-PN (stage 1 or 2) with or without CM were randomly assigned 2:1 and received 300-mg weekly subcutaneous inotersen or placebo for 15 months. CM was defined as diagnosis of hATTR-CM or =1.3 cm interventricular septum thickness (by echocardiography) at baseline. Primary endpoints were change from baseline to week 66 in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score and the modified Neuropathy Impairment Score+7 (mNIS+7). The Optum SF-36v2 Health Survey (SF-36v2) score was an exploratory outcome. Results At baseline, 69% of patients were male, mean age was 59 years (range, 27-81 years) and 63% (108/172) had CM. Of patients given placebo and inotersen, 55% (33/60) and 67% (75/112), respectively, had CM. Patients with CM had higher baseline mNIS+7 scores (higher scores indicate worse neuropathy), higher Norfolk QOL-DN total scores (higher scores indicate worse QOL) and lower SF-36v2 physical component summary scores (lower scores indicate worse QOL) than patients without CM. Inotersen-treated patients achieved highly statistically significant benefit compared with placebo in Norfolk QOL-DN total score (P=0.0006) and mNIS+7 (P Conclusion Significant improvement in Norfolk QOL-DN and SF-36v2 scores, which include several domains related to patient well-being and activities of daily living, suggest that inotersen improves the QOL of patients with hATTR-PN with CM, the hATTR population with the greatest disease burden.

P699 The concordance of Short Form-36 Health Survey scores with Mayo scores in the tofacitinib ulcerative colitis clinical programme

Abstract Background The Short Form-36 Health Survey version 2 (SF-36v2) is a generic health-related quality-of-life (HRQoL) instrument [1]. Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). In these exploratory analyses the concordance between total and partial Mayo scores and SF-36v2 scores was evaluated in patients with UC in the Phase 3 tofacitinib 8-week OCTAVE Induction 1&amp;2 (NCT01465763; NCT01458951) and 52-week OCTAVE Sustain (NCT01458574) studies. Methods A repeated measures regression model was used to evaluate the relationship between total and partial Mayo scores (as predictor) and SF-36v2 component and domain scores. A sensitivity analysis to assess the linearity assumption was performed using Mayo score as a categorical anchor (represented by integer values 0–12 [total] or 0–9 [partial]). Previous analyses identified clinically important differences (CIDs) in total and partial Mayo scores as changes of 3 points and 2.25 points, respectively [2]. Mean differences in SF-36v2 component and domain scores were compared with their recommended group-level CID thresholds [3]. Results Clinically meaningful differences of 3 points and 2.25 points in total and partial Mayo scores, respectively, were generally associated with clinically meaningful differences in SF-36v2 component and domain scores, with the exception of Role-Emotional with partial Mayo score in the pooled induction studies and with total Mayo score in the maintenance study. In the induction studies, a 3-point difference in total Mayo score was associated with a mean difference exceeding CIDs in both the SF-36v2 Physical Component Summary score (mean improvement 4.5; 95% confidence interval [CI] 4.2, 4.7) and Mental Component Summary score (mean improvement 5.0; 95% CI 4.6, 5.3). Results were closely aligned when Mayo score was used as a categorical or continuous anchor, supporting a linear relationship between Mayo score and SF-36v2 scores (Figure). Similar results were observed in the maintenance study, and when assessing the relationship of partial Mayo score with SF-36v2 scores. Conclusion Clinically meaningful decreases in disease activity, as measured by Mayo score, were associated with clinically meaningful benefits in HRQoL, as measured by SF-36v2 component and domain scores. These findings highlight the impact that disease activity has on HRQoL and may assist with articulating the treatment effect of tofacitinib on specific domains. References

Effects of monthly buprenorphine extended-release injections on patient-centered outcomes: A long-term study

IntroductionThe physical, social, psychological, and economic burden of opioid use disorder (OUD) is substantial. As of the year 2019, the predominant focus of OUD research was outcomes such as retention and abstinence. We report herein the effects of extended-release buprenorphine (BUP-XR), the first FDA-approved subcutaneously injected, monthly treatment for OUD, on patient-centered outcomes. Materials and methodsPatient-centered outcomes were collected during an open-label safety study of participants with OUD (NCT# 02510014) evaluating BUP-XR. Measures collected during the study included the EQ-5D-5L, SF-36v2, Treatment Effectiveness Assessment (TEA), Addiction Severity Index-Lite (ASI-Lite), employment/insurance status questionnaire, and Medication Satisfaction Questionnaire (MSQ). Changes from baseline to end of study week 49 were analyzed using mixed models for repeated measures. “Baseline” was defined as the value collected prior to the first BUP-XR injection. Results presented are for those participants who initiated treatment on BUP-XR during the open-label study and were eligible to receive up to 12 injections. ResultsFour hundred twelve participants were included in analyses; 206 participants discontinued BUP-XR prematurely. Mean EQ-5D-5L scores remained stable from baseline to end of study. Statistically significant improvements from baseline to end of study were noted for the SF-36v2 mental component summary score (difference = 5.0, 95%CI: 3.5–6.5) and 7 of 8 domain scores (P < .05 for all comparisons); the SF-36v2 physical component summary remained stable from baseline to end of study. The TEA total score (difference = 9.3 points, 95%CI: 8.0–10.5) and 4 of 4 domain scores (difference = 2–3 points per domain) significantly improved from baseline to end of study. Significant improvements (P < .05 for all comparisons) on the ASI-Lite were seen for all problem areas except alcohol use from baseline to end of study. Employment rate increased 7% whereas health insurance status remained stable from baseline to end of study. Medication satisfaction measured using the MSQ was >88% at end of study. ConclusionsTreatment with BUP-XR monthly injections for up to 12 months in this cohort of treatment-seeking individuals with OUD led to positive PCOs and high treatment satisfaction, which correspond to personal recovery.

PNS374 CLINICAL BURDEN AND HEALTH-RELATED QUALITY OF LIFE IN CAREGIVERS OF CANCER PATIENTS: RESULTS FROM LINKING ELECTRONIC HEALTH RECORDS TO PATIENT-REPORTED OUTCOMES

To examine depression and anxiety prevalence and health-related quality of life (HRQoL) in cancer caregivers. The National Health and Wellness Survey (NHWS), a nationally-representative Internet survey of adults (≥18 years), was linked to a large US ambulatory electronic health records (EHR) database using a HIPAA-compliant matching algorithm. The study population included NHWS respondents between 2015-2018 who reported being a caregiver of cancer patients and those who reported not being a caregiver. Prevalence of depression and anxiety among caregivers were estimated using self-reported physician diagnoses and ICD-10 codes in the EHR. Analysis of variance and Chi-squared tests were used to compare depression (Patient Health Questionnaire 9-item (PHQ-9)) and anxiety (Generalized Anxiety Disorder 7-item (GAD-7)) severity and HRQoL (SF-36v2 physical component summary (PCS) and mental component summary (MCS)) between caregivers and non-caregivers. Of 13,928 NHWS respondents linked to EHR data (mean age = 51.6 years, 64.3% females, 78.4% White), 298 (2.1%) reported being caregivers to cancer patients. The prevalence of depression and anxiety were 38.9% and 36.2% using self-reported diagnoses and 18.8% and 17.6% based on EHR diagnoses. Compared with non-caregivers, cancer caregivers were more likely have generalized anxiety disorder (33.8% vs 14.0%, p < 0.001), based on the GAD-7. Cancer caregivers also reported greater severity of depressive symptoms based on the PHQ-9 and were more likely to have mild (24.2% vs. 18.8%), moderate (15.5% vs 8.1%), and severe (18.0 % vs. 7.0%) depression (all p < 0.001), compared with non-caregivers. Compared with non-caregivers, cancer caregivers reported significantly lower MCS (43.5 vs. 48.1, p < 0.001) and PCS (46.3. vs 49.0, p < 0.001). Cancer caregivers reported poorer HRQoL and were more likely to report experiencing anxiety and depressive symptoms. Linking data enabled assessment of both self-reported and clinical diagnoses to characterize burden among cancer caregivers.

Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs

ObjectivesTofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug...

Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond

ObjectivesTofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). Patient-reported outcomes (PROs) were evaluated in patients with PsA with inadequate responses to tumour necrosis factor inhibitors...

Minimum Clinically Important Difference in SF-36 Scores for Use in Degenerative Cervical Myelopathy.

Post-hoc analysis of 606 patients enrolled in the AOSpine CSM-NA or CSM-I prospective, multicenter cohort studies. The aim of this study was to determine the minimum clinically important difference (MCID) in SF-36v2 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores in patients undergoing surgery for degenerative cervical myelopathy (DCM). There has been a shift toward focus on patient-reported outcomes (PROs) in spine surgery. However, the numerical scores of PROs lack immediate clinical meaning. The MCID adds a dimension of interpretability to PRO scales; by defining the smallest change, a patient would consider meaningful. The MCID of the SF-36v2 PCS and MCS were determined by distribution- and anchor-based methods comparing preoperative to 12-month scores. Distribution-based approaches included calculation of the half standard deviation and standard error of measurement (SEM). Change in Neck Disability Index (NDI) served as the anchor: "worse" (ΔNDI>7.5); "unchanged" (7.5≥ΔNDI>-7.5); "slightly improved" (-7.5≥ΔNDI>-15); and "markedly improved" (ΔNDI ≤-15). Receiver operating characteristic (ROC) analysis was performed to determine the change score for the MCID with even sensitivity and specificity to distinguish patients who were "slightly improved" versus "unchanged" on the NDI. The MCID for the SF-36v2 PCS and MCS were 4.6 and 6.8 by half standard deviation and 2.9 and 4.3 by SEM, respectively. By ROC analysis, the MCID was 3.9 for the SF-36v2 PCS score and 3.2 for the SF-36v2 MCS score. Using a cutoff of 4 points, the SF-36v2 PCS had a sensitivity of 72.2% and specificity of 68.1%, and MCS 61.9% and 64.6%, respectively, in separating patients who were "markedly improved" or "slightly improved" from those who were "unchanged" or "worse." We found the MCID of the SF-36v2 PCS and MCS to be 4 points. This will facilitate use of the SF-36v2 as an outcome in future studies of DCM. 3.