Improvement In Health-related Quality Of Life Outcomes Research Articles

Cancer rehabilitation services for older women with breast cancer: Impact on health-related quality of life outcomes.

Older breast cancer survivors (BCS, age ≥ 65) are vulnerable to experiencing persistent symptoms and associated declines in health-related quality of life (HRQOL). In research trials, cancer rehabilitation interventions (physical or occupational therapy, PT/OT) have been shown to enhance HRQOL, but the impact of community-based PT/OT services for older BCS is unknown. We performed a retrospective, observational study to better understand the impact of PT/OT services on the HRQOL of older BCS. Outcomes and covariates were extracted from the outpatient rehabilitation medical record. HRQOL outcomes included: PROMIS® global physical health (GPH), global mental health (GMH), physical function (PF), and ability to participate in social roles and activities (SRA). Linear mixed-effect models were used to examine change in HRQOL outcomes and explore the influence of patient age and service type (PT/OT). ICD-10 codes were examined and compared between service types to describe the impairments treated. PT/OT cases (N = 694) were 71.79 ± 5.44 years old and participated in a median of 11 visits (IQR: 7.0-17.25) over 9.71 weeks (IQR: 6.29-15.29). Most (84.4%) attended PT (n = 579; 84%) versus OT (n = 115; 16%). Overall, significant improvement was observed in each HRQOL outcome (GPH: +3.00, p < 0.001; GMH: +1.80, p < 0.001; PF: +1.97, p < 0.001; SRA: +2.34, p < 0.001). Service type influenced only GPH (p = 0.041); mean improvement was +3.24 (SE: 0.290, p < 0.001) for PT cases and + 1.78 for OT cases (SE: 0.651, p = 0.007). PT cases commonly received treatment for weakness/atrophy, pain, walking, and posture; OT cases commonly received treatment for lymphedema and scarring/fibrosis. No age effects were observed. In this large study of older BCS who participated in community-based PT/OT services across the United States, we observed significant improvements in HRQOL outcomes that are important to older BCS and their providers. Although more research is needed, these findings suggest that improved access to PT/OT could help address unmet HRQOL needs among this population.

Health-related quality-of-life in treatment-naive CLL/SLL patients treated with zanubrutinib versus bendamustine plus rituximab

Objective Zanubrutinib is a highly selective, next-generation Bruton’s tyrosine kinase inhibitor. In the phase 3 SEQUOIA trial (NCT03336333), treatment with zanubrutinib resulted in significantly improved progression-free survival compared to bendamustine plus rituximab (BR) in adult patients with treatment-naïve chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) without del(17p). The current analysis compared the effects of zanubrutinib versus BR on patients’ health-related quality-of-life (HRQoL). Methods In the SEQUOIA trial, patient-reported outcomes (PROs) were assessed at baseline and every 12 weeks (3 cycles) using the EORTC QLQ-C30 and EQ-5D-5L. Descriptive analyses were performed on all the questionnaires’ scales and a mixed model for repeated measures was performed using the key QLQ-C30 endpoints of global health status/QoL (GHS/QoL), physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting at weeks 12 and 24. Results Compared with BR-treated patients, those in the zanubrutinib arm experienced greater improvements in HRQoL outcomes at both weeks 12 and 24. By week 24, mean change differences (95% confidence interval) between the arms were significant for GHS/QoL (4.9 [0.9, 9.0]), physical functioning (3.8 [0.8, 6.7]), diarrhea (−6.2 [−10.0, −2.5]), fatigue (−4.5 [−8.9, −0.1]), and nausea/vomiting (−4.5 [−8.9, −0.1]); role functioning (4.8 [−0.2, 9.7]) was marginally better in the zanubrutinib arm and there were no differences in pain symptoms (−0.4 [−4.3, 5.1]) between the arms. Conclusions During the first 24 weeks of treatment, zanubrutinib was associated with better HRQoL outcomes in patients with treatment-naive CLL/SLL without del(17p) compared to BR. Trial registration The SEQUOIA trial is registered on clinicaltrials.gov as SEQUOIA trial (NCT03336333).

Implementation and evaluation of a remote geriatric assessment and intervention program in Brazil.

This study sought to determine the feasibility and acceptability of a remote geriatric assessment (GA) and implementation (GAIN) program in Brazil. The authors also explored the effect of this program on health-related quality of life (HR-QOL) outcomes 3 months after initiating treatment. This is a longitudinal study enrolling older adults (65+ years), diagnosed with any type of solid tumor, scheduled to initiate chemotherapy in a networked Brazilian cancer center. The GA was performed through telehealth. We assessed the feasibility of the remote GA, acceptability to patients, and changes in patient-centered outcomes (HR-QOL, mood, function) from baseline to month 3. Linear mixed model analysis was done, adjusting for age, gender, race, income, and disease stage. Fifty-six patients completed all intended assessments. Notably, the threshold of feasibility was 70% and there was 92% complete adherence. Average age was 76years old (SD=7.2). Most patients were female (57%), married (59%), and had a college degree (46%). The most common diagnoses were gastrointestinal (39%) and gynecological cancers (18%); most were diagnosed at an advance disease stage (77%). A total of 32 patients were referred to a remote appointment and 86% followed this recommendation(s). Significant improvement in Functional Assessment of Cancer Therapy - General FACT-G (mean difference, 6.04; p<.001), Geriatric Depression Scale (mean difference, -0.86; p=.008), and instrumental activities of daily living ratio (mean difference, 0.17; p<.001) were found. Remote GAIN is feasible and acceptable to older adults with cancer receiving treatment in Brazil. The authors also found significant improvement in HR-QOL outcomes over time. Notably, this GAIN program could guide early detection of chemotherapy toxicity and improving patient-reported outcomes in low-resource environments.

Single-level Lumbar Fusion Versus Total Joint Arthroplasty: A Comparison of 1-year Outcomes.

Primary hip and knee arthroplasty represent two of the most successful orthopaedic surgical interventions in the past century. Similarly, lumbar fusion (LF) remains a valuable, evidence-based option to relieve pain and disability related to spinal degenerative conditions. This study evaluates the relative improvements in 1-year health-related quality of life (HRQOL) measures among patients undergoing primary single-level LF, primary total hip arthroplasty (THA), and primary total knee arthroplasty (TKA). Patients older than 18 years who underwent primary single-level posterior LF (posterolateral decompression and fusion with or without transforaminal lumbar interbody fusion, involving any single lumbar level), TKA, and THA at a single academic institution were retrospectively identified. Patient demographics and surgical characteristics were collected. HRQOL measures were collected preoperatively and at 1-year postoperative time point including Short-Form 12 Physical Component Score (PCS) and Mental Component Score (MCS) along with subspecialty-specific outcomes. A total of 2,563 patients were included (346 LF, 1,035 TKA, and 1,182 THA). Change in MCS-12 and PCS-12 after LF did not vary markedly by preoperative diagnosis. LF patients had a significantly lower preoperative MCS-12 (LF: 50.8, TKA: 53.9, THA: 52.9, P < 0.001), postoperative MCS-12 (LF: 52.5, TKA: 54.8, THA: 54.5, P < 0.001), postoperative PCS-12 (LF: 40.1, TKA: 44.0, THA: 43.9, P < 0.001), ΔPCS-12 (LF: 7.9, TKA: 10.8, THA: 11.9, P < 0.001), and PCS-12 recovery ratio (LF: 10.7%, TKA: 15.1%, THA 16.6%, P < 0.001) compared with TKA and THA patients. In regression analysis, both TKA and LF were found to be independently associated with a smaller ΔPCS-12 improvement (TKA: β = -1.36, P = 0.009; LF: β = -4.74, P < 0.001) compared with THA. TKA (β = -1.42, P = 0.003) was also independently associated with a smaller ΔMCS-12 improvement compared with THA. Patients undergoing single-level LF, TKA, and THA demonstrate notable improvements in HRQOL outcomes at 1 year postoperatively compared with preoperative baseline scores. The greatest improvements were found among THA patients, followed subsequently by TKA and LF patients. Both LF and TKA were independently associated with markedly less improvement in physical disability at 1 year postoperatively compared with THA. Retrospective Cohort Study.

P1740: HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) TREATED WITH IDECABTAGENE VICLEUCEL VS BELANTAMAB MAFODOTIN: A MATCHING-ADJUSTED INDIRECT COMPARISON STUDY

Background: Patients (pts) with RRMM who are triple-class exposed (TCE; to an immunomodulatory imide drug [IMiD® agent], proteasome inhibitor [PI], and anti-CD38 monoclonal antibody [mAb]) have poor clinical outcomes and poor health-related quality of life (HRQoL). The B-cell maturation antigen (BCMA)-directed CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121) received regulatory approval in the US for pts with RRMM with ≥4 prior lines of therapy (LOT), including an IMiD agent, PI, and anti-CD38 mAb, and in Europe and Japan for pts with RRMM with ≥3 prior LOTs including an IMiD agent, PI, and anti-CD38 mAb. Ide-cel showed frequent, deep, and durable responses in TCE pts with RRMM in KarMMa, a phase 2, single-arm trial (NCT03361748). Clinically meaningful improvements in HRQoL outcomes vs baseline were observed. The BCMA-targeted antibody-drug conjugate belantamab mafodotin (BM) was approved in the US and Europe for pts with RRMM with ≥4 prior LOTs including an IMiD agent, PI and anti-CD38 mAb, based on data from the phase 2, single-arm DREAMM-2 trial (NCT03525678). There is a paucity of evidence comparing HRQoL for different treatment options approved in RRMM. Aims: To compare HRQoL outcomes for TCE pts with RRMM treated with ide-cel vs BM. Methods: Data were analyzed using unanchored matching-adjusted indirect comparisons. Between-study differences in pt characteristics were adjusted using individual-level pt data from KarMMa to align with summary-level pt characteristics from DREAMM-2. The ide-cel-treated population (N=128; median follow-up 15.4 months) from KarMMa (of whom, 54 pts received the target dose of 450×106 CAR+ T cells) and the intention-to-treat population (N=97; median follow-up 13.0 months) from DREAMM-2 who received the 2.5 mg/kg dose of BM (Popat et al. HemaSphere 2020;4:S1. EP1746) were analyzed. Predefined outcomes of interest were differences in mean change from baseline scores for the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) pain, fatigue, and global health/QoL domains, and the QLQ-Multiple Myeloma (MY20) pain domain. Analyses were performed at 2, 3, 4, 6, 9, and 12 months of follow-up. Given differences in time points of evaluation between KarMMa and DREAMM-2, the nearest neighbor approach was used. Pt characteristics included as covariates in the propensity model included: age, sex, race, years from initial diagnosis, disease stage, and number of prior treatments. Sensitivity analyses included additional covariates: high-risk cytogenetics and extramedullary disease. Results: Ide-cel was associated with improved HRQoL vs BM at all evaluated time points for the QLQ-C30 global health status/QoL domain (Table). Improved HRQoL scores were statistically significant for ide-cel vs BM at 6 and 9 months for the QLQ-C30 fatigue domain (HRQoL scores were numerically better for ide-cel vs BM at all other time points). Similarly, HRQoL scores favored ide-cel vs BM at all evaluated time points for the QLQ-C30 pain and QLQ-MY20 pain domains, with statistically significant findings at 4, 6, and 9 months for QLQ-C30 and 3, 4, and 6 months for QLQ-MY20. Sensitivity analyses were consistent with the base case analyses. Image:Summary/Conclusion: While this analysis was limited by the availability of aggregate data from DREAMM-2, which may influence the outcomes of interest, results suggest that one-time treatment with ide-cel offers improved HRQoL vs BM across the QLQ-C30 pain, fatigue, and global health status/QoL domains, as well as the QLQ-MY20 pain domain.

P286 Sustained improvement in health-related quality of life outcomes in patients with Ulcerative Colitis with long-term tofacitinib treatment in the open-label extension study, OCTAVE Open

Abstract Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Tofacitinib induction and maintenance therapy has previously been shown to improve health-related quality of life (HRQoL) outcomes. Here, we present HRQoL data from patients (pts) with UC who received tofacitinib 5 or 10 mg twice daily (BID) in the Phase 3 open-label, long-term extension (OLE) study (OCTAVE Open; NCT01470612), up to Month (M)72. Methods Proportions of pts with an Inflammatory Bowel Disease Questionnaire (IBDQ) total score ≥170, and EuroQol-5D (EQ-5D) and Short Form-36 Health Survey (SF-36) scores were analysed up to M72 in 4 subpopulations in the OLE study: ‘maintenance remitters’ completed OCTAVE Sustain in remission and received tofacitinib 5 mg BID in the OLE study; in contrast, ‘maintenance treatment failures’ (induction responders who experienced treatment failure), ‘maintenance non-remitters’ and ‘induction non-responders (IndNR)’ received tofacitinib 10 mg BID in the OLE study (Figure 1). Data were analysed for each subpopulation overall and stratified by prior tumour necrosis factor inhibitor (TNFi) failure, prior immunosuppressant failure and baseline corticosteroid use. Results Baseline demographics and clinical characteristics for each subpopulation are shown in Table 1. Among the 163 maintenance remitters, HRQoL outcomes were maintained up to M72: 80.0% of pts had an IBDQ total score ≥170 (Figure 1); changes from baseline in EQ-5D scores up to M72 and SF-36 scores up to M33 were minimal (eg M72 EQ-5D utility score -0.07 [standard deviation 0.10]; M33 SF-36 physical functioning score -1.3 [8.3]). Among pts continuing long-term tofacitinib treatment, improvement in IBDQ total score was maintained/achieved by M2 (first post-baseline assessment), and was stable up to M72, with maintenance treatment failures and IndNR subpopulations experiencing the largest improvements from baseline (Figure 1). Similar trends were observed for improvement in EQ-5D and SF-36 scores. Improvements in HRQoL outcomes were independent of prior TNFi failure, prior immunosuppressant failure or baseline corticosteroid use, eg in maintenance remitters with prior TNFi failure, 90.9% of pts had IBDQ total score ≥170 at M60 vs 88.9% of pts without prior TNFi failure. Conclusion Sustained beneficial effects in HRQoL were observed among pts continuing long-term tofacitinib treatment in OCTAVE Open. In maintenance remitters, improvements in all HRQoL outcomes were maintained with tofacitinib therapy. In pts who entered the OLE study not in remission and received tofacitinib 10 mg BID, HRQoL improvements were observed within the first 2 months, and were maintained up to M72, regardless of treatment history including prior TNFi failure.

UK Medical Cannabis Registry: an analysis of clinical outcomes of medicinal cannabis therapy for generalized anxiety disorder

ABSTRACT Objectives Anxiety disorders are one of the most common reasons for seeking treatment with cannabis-based medicinal products (CBMPs). Current pharmacological treatments are variable in efficacy and the endocannabinoid system has been identified as a potential therapeutic target. This study aims to detail the changes in health-related quality-of-life (HRQoL) and clinical safety following CBMP therapy for generalized anxiety disorder. Methods A case series from the UK Medical Cannabis Registry was performed. Primary outcomes included changes from baseline in patient-reported outcome measures (the General Anxiety Disorder Scale (GAD-7), EQ-5D-5L (a measure of health-related quality of life), and Sleep Quality Scale (SQS)) at 1, 3 and 6 months. Statistical significance was defined as p<0.050. Results Sixty-seven patients were treated for generalized anxiety disorder. Statistically significant improvements were observed in GAD-7, EQ-5D-5L Index Value, EQ5D Visual Analog Scale, and SQS scores at 1, 3 and 6 months (p<0.050). Twenty-five (39.1%) patients reported adverse events during the follow-up period. Conclusion This study suggests that CBMPs may be associated with improvements in HRQoL outcomes when used as a treatment for generalized anxiety disorder. These findings must be treated with caution considering limitations of study design; however this data may help inform future clinical studies and practice. Plain Language Summary Anxiety disorders are the most prevalent psychiatric illness type in the United Kingdom, with 8.2 million cases reported in 2010. Generalized anxiety disorder (GAD), the most common anxiety disorder, debilitates, and so reduces the quality of life of those who suffer from the condition. The efficacy of current treatments for GAD varies greatly from person-to-person. The endocannabinoid system in the human body is currently attracting a lot of attention in the scientific community as it can be targeted by chemicals in the cannabis plant to produce therapeutic effects in order to treat GAD. There is, however, a lack of studies investigating the effects of medicinal cannabis in GAD, and so this study aims to explore the drug’s effect on quality of life in patients suffering from GAD. Sixty-seven patients who attended the Sapphire Clinics for medicinal cannabis treatment for GAD were included in the study. The results from this study highlight that medicinal cannabis may improve generalized anxiety disorder, general health-related quality of life, and sleep-specific outcomes at 1, 3, and 6 months after starting treatment. There was also a low number of severe, disabling, and life-threatening adverse events experienced by patients. Although this study explores the effects of medicinal cannabis in a real clinical setting, the results were not compared to other types of treatment. Future studies with a comparator are therefore needed before concluding the true effects of medicinal cannabis in patients with GAD.

Effect of depression and anxiety on health-related quality of life outcomes and patient satisfaction after surgery for cervical compressive myelopathy.

Preoperative mood disorders such as depression and anxiety are known to be associated with poor health-related quality of life (HRQOL) outcomes after lumbar spine surgery. However, the effects of preoperative depression and anxiety on postoperative HRQOL outcomes and patient satisfaction in cervical compressive myelopathy are yet to be clarified. This study aimed to investigate the effect of depression and anxiety on HRQOL outcomes and patient satisfaction following surgery for cervical compressive myelopathy. The authors reviewed the cases of all consecutive patients with cervical compressive myelopathy who had undergone surgical treatment in the period between January 2012 and March 2017 at their institution. Using the Hospital Anxiety and Depression Scale (HADS), the authors classified patients as depressed (HADS-D+) or not depressed (HADS-D-) and anxious (HADS-A+) or not anxious (HADS-A-). Patient HRQOL was evaluated preoperatively and at the end of at least 1 year after surgery using the physical and mental component summaries of the SF-12 Health Survey, EQ-5D (EuroQol health survey of five dimensions), Neck Disability Index, and Japanese Orthopaedic Association scale. Patient satisfaction was evaluated on the basis of a seven-item questionnaire and divided into two categories: satisfied and dissatisfied. Preoperative HRQOL statuses, postoperative improvements in HRQOL outcomes, and patient satisfaction were compared between the groups. Among the 121 patients eligible for inclusion in the study, there were 69 patients (57.0%) without depression (HADS-D-) and 52 (43.0%) with depression (HADS-D+) and 82 patients (67.8%) without anxiety (HADS-A-) and 39 (32.2%) with anxiety (HADS-A+). All patients who completed both the preoperative and postoperative questionnaires had significant postoperative improvements in all HRQOL outcomes. The HADS-D+ and HADS-A+ patients had poorer preoperative HRQOL statuses than the HADS-D- and HADS-A- patients, respectively. However, statistically significant improvements in all HRQOL outcomes were observed in both HADS-D+ and HADS-A+ patients. Patient satisfaction was comparable between the HADS-D or HADS-A groups. Cervical compressive myelopathy patients with preoperative depression or anxiety according to the HADS tool had worse preoperative HRQOL statuses. However, patients with cervical compressive myelopathy showed significant improvements in HRQOL outcomes and had sufficient levels of satisfaction after surgery regardless of the presence of preoperative depression or anxiety.

The impact of age and preoperative health-related quality of life on patient-reported improvements after total hip arthroplasty.

BackgroundTotal hip arthroplasty (THA) is a common surgical procedure and approximately 9,500 of these surgeries are performed annually in Denmark. The operation is considered effective and successful with respect to complications, mortality, and implant survival. However, using patient-reported outcome measures, up to 10% of patients are not satisfied with the outcome of their operation. To address this, it is important to find out why some patients experience impaired outcomes after THA. The purpose of this study was to investigate the impact of age and preoperative health-related quality of life (HRQoL) on improvements in HRQoL after THA.MethodsA cohort study was conducted with follow-up at 3 and 12 months. Patients were included from September 2008 to December 2013. We analyzed 1,283 THA cases. HRQoL was measured using the EuroQol-5 Domain. Analyses were carried out with multiple linear regression and adjusted for relevant variables available in the data set.ResultsA significant positive association was found between age and HRQoL outcomes for patients who underwent THA at both 3 (β [regression coefficient] 0.0026, confidence interval [CI] 0.0013; 0.0039, p<0.001) and 12 (β 0.0020 CI 0.0008; 0.0032, p=0.001) months of follow-up. A clinically relevant change was achieved with an increase in age of 12–15 years. A significant negative association was found between preoperative HRQoL and HRQoL outcomes at both 3 (β −0.841 CI −0.886; −0.795, p<0.001) and 12 (β −0.804 CI −0.844; −0.764, p<0.001) months of follow-up.ConclusionContrary to our expectations, older patients had more improvements in HRQoL outcomes after THA. A high preoperative HRQoL seems to inhibit improvements in HRQoLs after THA.

Impact of age on the likelihood of reaching a minimum clinically important difference in 374 three-column spinal osteotomies

Spinal osteotomies for adult spinal deformity correction may include resection of all 3 spinal columns (pedicle subtraction osteotomy [PSO] and vertebral column resection [VCR]). The relationship between patient age and health-related quality of life (HRQOL) outcomes for patients undergoing major spinal deformity correction via PSO or VCR has not been well characterized. The goal of this study was to characterize that relationship. This study was a retrospective review of 374 patients who had undergone a 3-column osteotomy (299 PSOs and 75 VCRs) and were part of a prospectively collected, multicenter adult spinal deformity database. The consecutively enrolled patients were drawn from 11 sites across the United States. Health-related QOL outcomes, according to the visual analog scale (VAS), Oswestry Disability Index (ODI), 36-Item Short-Form Health Survey (SF-36, physical component score [PCS] and mental component score), and Scoliosis Research Society-22 questionnaire (SRS), were evaluated preoperatively and 1 and 2 years postoperatively. Differences and correlations between patient age and HRQOL outcomes were investigated. Age groupings included young (age ≤ 45 years), middle aged (age 46-64 years), and elderly (age ≥ 65 years). In patients who had undergone PSO, age significantly correlated (Spearman's correlation coefficient) with the 2-year ODI (ρ = 0.24, p = 0.0450), 2-year SRS function score (ρ = 0.30, p = 0.0123), and 2-year SRS total score (ρ = 0.30, p = 0.0133). Among all patients (PSO+VCR), the preoperative PCS and ODI in the young group were significantly higher and lower, respectively, than those in the elderly. Among the PSO patients, the elderly group had much greater improvement than the young group in the 1- and 2-year PCS, 2-year ODI, and 2-year SRS function and total scores. Among the VCR patients, the young age group had much greater improvement than the elderly in the 1-year SRS pain score, 1-year PCS, 2-year PCS, and 2-year ODI. There was no significant difference among all the age groups as regards the likelihood of reaching a minimum clinically important difference (MCID) within each of the HRQOL outcomes (p > 0.05 for all). Among the PSO patients, the elderly group was significantly more likely than the young to reach an MCID for the 1-year PCS (61% vs 21%, p = 0.0077) and the 2-year PCS (67% vs 17%, p = 0.0054), SRS pain score (57% vs 20%, p = 0.0457), and SRS function score (62% vs 20%, p = 0.0250). Among the VCR patients, the young group was significantly more likely than the elderly patients to reach an MCID for the 1-year (100% vs 20%, p = 0.0036) and 2-year (100% vs 0%, p = 0.0027) PCS scores and 1-year (60% vs 0%, p = 0.0173) and 2-year (70% vs 0%, p = 0.0433) SRS pain scores. The PSO and VCR are not equivalent surgeries in terms of HRQOL outcomes and patient age. Among patients who underwent PSO, the elderly group started with more preoperative disability than the younger patients but had greater improvements in HRQOL outcomes and was more likely to reach an MCID at 1 and 2 years after treatment. Among those who underwent VCR, all had similar preoperative disabilities, but the younger patients had greater improvements in HRQOL outcomes and were more likely to reach an MCID at 1 and 2 years after treatment.

Effects of Fostamatinib (R788), an Oral Spleen Tyrosine Kinase Inhibitor, on Health-related Quality of Life in Patients with Active Rheumatoid Arthritis: Analyses of Patient-reported Outcomes from a Randomized, Double-blind, Placebo-controlled Trial

To assess the influence of fostamatinib on patient-reported outcomes (PRO) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX). Patients taking background MTX (N = 457) were enrolled in a phase II clinical trial (NCT00665925) and randomized equally to placebo, fostamatinib 100 mg twice daily (bid), or fostamatinib 150 mg once daily (qd) for 24 weeks. Self-administered PRO measures included pain, patient's global assessment (PtGA) of disease activity, physical function, health-related quality of life (HRQOL), and fatigue. Mean change from baseline and a responder analysis of the proportion of patients achieving a minimal clinically important difference were determined. At Week 24, there were statistically significant improvements in pain, PtGA, physical function, fatigue, and the physical component summary of the Medical Outcomes Study Short Form-36 (SF-36) for fostamatinib 100 mg bid compared with placebo. Mean (standard error) changes from baseline in the fostamatinib 100 mg bid group versus the placebo group were -31.3 (2.45) versus -17.8 (2.45), p < 0.001 for pain; -29.1 (2.26) versus -16.7 (2.42), p < 0.001 for PtGA; -0.647 (0.064) versus -0.343 (0.062), p < 0.001 for physical function; 7.40 (1.00) versus 4.50 (0.94), p < 0.05 for fatigue; 8.52 (0.77) versus 4.90 (0.78), p < 0.01 for SF-36 physical component score; and 3.99 (0.93) versus 3.71 (0.99), p = 0.83 for SF-36 mental component score. Patients receiving fostamatinib 150 mg qd showed improvements in some PRO, including physical function. Patients treated with fostamatinib 100 mg bid showed significant improvements in HRQOL outcomes.

Can erectile function be predicted after prostate cancer treatment?

Can erectile function be predicted after prostate cancer treatment?

Improved quality of life with cardiac rehabilitation for post-myocardial infarction patients in Korea

Health-related quality of life (HRQOL) has been used as a primary health outcome in cardiac rehabilitation programs (CRP). This study aimed to evaluate the effects of an 8-week CRP on HRQOL and exercise capacity in myocardial infarction (MI) patients in Korea. After matching on gender, age, and left ventricular ejection fraction, 60 subjects with a first acute MI were allocated to either a CRP group (n=31) or a Control group (n=29). The 8-week CRP included hospital-based, supervised exercise training (three times per week, average intensity of 65% VO(2peak)) and individual education sessions. The Control group was instructed on a home-based exercise regimen without contact during the 8 weeks. At baseline and 8 weeks, HRQOL was assessed by the Quality of Life Index (QLI)-cardiac version III; exercise capacity by a treadmill test. After adjusting for education level, the overall QLI, health/functioning and psycho/spiritual scores showed greater increases in the CRP group than the Control group (p=.014, p=.016, and p=.036, respectively). We observed significant improvements in VO(2peak) (p<.0001), anaerobic threshold (p<.0001), and maximal exercise duration (p<.0001) in the CRP group, compared to the Control group. These findings suggest that the Korean CRP can lead to significant improvements in HRQOL outcomes and exercise capacity.

Efficacy of Hydrocortisone in Preventing Posttraumatic Stress Disorder Following Critical Illness and Major Surgery

Like other humans exposed to extreme trauma, patients who have been treated in an intensive care unit (ICU) often report traumatic memories. Extremely traumatic memories from the ICU in some of these patients are associated with the development of posttraumatic stress disorder (PTSD), which results in significant impairments in health-related quality of life (HRQL) outcomes of ICU therapy. Severely ill patients in the ICU often show insufficient endogenous glucocorticoid signaling, which has recently been termed critical illness-related corticosteroid insufficiency (CIRCI). We performed several controlled trials in ICU patients with suspected CIRCI from septic shock or cardiac surgery, which indicated that the administration of glucocorticoids (stress doses of hydrocortisone) during ICU treatment results in a significant reduction of PTSD symptoms in long-term survivors as well as improvements in HRQL outcomes. Stress doses of hydrocortisone could help to surmount impaired glucocorticoid signaling from CIRCI during critical illness resulting in a downregulation of the stress response as well as inhibition of traumatic memory retrieval and facilitated extinction of aversive information.