scholarly journals Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Atul Deodhar ◽  
Philip Mease ◽  
Helena Marzo-Ortega ◽  
Theresa Hunter ◽  
David Sandoval ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Work Productivity ◽  
Analysis Of Covariance ◽  
Activity Impairment ◽  
Work Activity ◽  
Work Impairment ◽  
Link Type ◽  
Dosing Regimens

Abstract Background Patients with non-radiographic axial spondyloarthritis experience negative impacts on sleep, work productivity, and activity impairment. Ixekizumab, a monoclonal antibody selectively targeting interleukin-17A, has shown efficacy in treating the signs and symptoms of non-radiographic axial spondyloarthritis. This analysis evaluated the effect of ixekizumab treatment on sleep, work productivity, and activity impairment in patients with non-radiographic axial spondyloarthritis. Methods COAST-X (NCT02757352) was a 52-week, phase 3, multicenter, randomised placebo-controlled trial evaluating 80-mg ixekizumab every 2 weeks and every 4 weeks in patients with active non-radiographic axial spondyloarthritis. Sleep disturbance was measured with the Jenkins Sleep Evaluation Questionnaire (JSEQ) and analysed using mixed-effects models for repeated measures. Work productivity and activity impairment were measured using the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis and analysed using analysis of covariance. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work; activity impairment was assessed regardless of work status. Results Overall, patients treated with both dosing regimens of ixekizumab reported numerically greater improvements in sleep than placebo through Week 52. At Weeks 16 and 52, patients treated with ixekizumab every 4 weeks had significantly greater improvements in presenteeism (p = 0.007 and p = 0.003, respectively) and overall work impairment (p = 0.014 and p = 0.005, respectively) and numeric improvements in absenteeism than placebo. Patients treated with ixekizumab every 2 weeks had numerically greater improvements in absenteeism, presenteeism, and overall work impairment than placebo. Both dosing regimens of ixekizumab were associated with significantly greater improvements in activity impairment than placebo (ixekizumab every 4 weeks: p = 0.003 at Week 16 and p = 0.004 at Week 52; ixekizumab every 2 weeks: p = 0.007 at Week 16 and p = 0.006 at Week 52). Conclusions Treatment with ixekizumab improved sleep, work productivity, and activity impairment in patients with nr-axSpA. Improvements in presenteeism and overall work impairment were sustained and consistent in the patients treated with ixekizumab every 4 weeks from Week 16 to Week 52. Improvements in activity impairment were sustained and consistent in both ixekizumab-treated groups from Week 16 to Week 52. Trial registration NCT02757352, May 2, 2016.

THU0384 IMPACT OF IXEKIZUMAB ON WORK PRODUCTIVITY IN NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS PATIENTS: RESULTS FROM THE COAST-X TRIAL AT 52 WEEKS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 426-426
Author(s):  
A. Deodhar ◽  
P. J. Mease ◽  
L. S. Gensler ◽  
P. Rahman ◽  
V. Navarro-Compán ◽  
...  
Keyword(s):  
Axial Spondyloarthritis ◽  
Work Productivity ◽  
Analysis Of Covariance ◽  
Full Time ◽  
Research Support ◽  
Open Label ◽  
Activity Impairment ◽  
Work Activity ◽  
Work Impairment ◽  
Part Time

Background:Patients with non-radiographic axial spondyloarthritis (nr-axSpA) experience impairments in health-related quality of life comparable to those seen in ankylosing spondylitis, including impacts on work productivity. Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A and effectively treats axial spondyloarthritis.1,2,3Objectives:This analysis evaluated the effect of IXE treatment for 52 weeks on work productivity and activity impairment as measured by absenteeism, presenteeism, overall work impairment, and activity impairment in patients with active nr-axSpA.Methods:COAST-X (NCT02757352) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group outpatient study investigating the efficacy and safety of 80 mg IXE every 2 weeks (Q2W) and every 4 weeks (Q4W) compared to placebo (PBO) in 303 patients naïve to biologic disease-modifying anti-rheumatic drugs with active nr-axSpA during a 52-week treatment period. From Weeks 16 through 44, if patients’ disease activity required escalation of treatment at investigator discretion, patients were switched to open-label IXE Q2W or subsequent tumor necrosis factor inhibitor treatment. Analysis was performed for the intent-to-treat population, which included data up to the time of biologic switching. Patients who switched to open-label IXE were considered non-responders. Changes from baseline in work productivity were measured for patients reporting full- or part-time work at Weeks 16 and 52 with the Work Productivity and Activity Impairment (WPAI) Questionnaire for Spondyloarthritis and analyzed with an analysis of covariance model including treatment, geographic region, screening magnetic resonance imaging and C-reactive protein level status, and baseline value as factors. Missing data was imputed using the modified baseline observation carried forward.Results:A majority of patients (63.5–65.7%) reported part-time or full-time paid work at baseline, with baseline scores for presenteeism and overall work activity slightly higher for patients in the PBO arm (p<0.05). Patients treated with IXE Q4W had significantly greater improvement than PBO in activity impairment at Weeks 16 (p=0.003) and 52 (p=0.004), presenteeism at Weeks 16 (p=0.007) and 52 (p=0.003), and overall work impairment at Weeks 16 (p=0.014) and 52 (p=0.005; Figure). Patients treated with IXE Q2W had significantly greater improvement than PBO in activity impairment at Weeks 16 (p=0.007) and 52 (p=0.006; Figure). Patients treated with either IXE regimen had numeric improvements in all WPAI measures compared to those receiving PBO at Weeks 16 and 52 (Figure).Conclusion:Patients with nr-axSpA treated with either IXE regimen had significant improvements in activity impairment compared to PBO. Patients receiving IXE Q4W also had significant improvements in presenteeism and overall work impairment.References:[1]Sieper, et al. (2016)Clin Exp Rheumatol.34(6):975-83.[2]Van der Heijde, et al. (2018)Lancet. 392(10163):2441-51.[3]Deodhar, et al. (2019)Arthritis Rheumatol.71(4):599-611.Figure.Changes from baseline in A) Absenteeism, B) Presenteeism, C) Overall Work Impairment, and D) Activity Impairment.Disclosure of Interests:Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer, Sun Pharma, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB Pharma, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Proton Rahman Grant/research support from: Janssen and Novartis, Consultant of: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, and Pfizer., Speakers bureau: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, Pfizer, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Baojin Zhu Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB

scholarly journals Impact of biological therapy on work outcomes in patients with axial spondyloarthritis: results from the British Society for Rheumatology Biologics Register (BSRBR-AS) and meta-analysis

2018 ◽  
Vol 77 (11) ◽  
pp. 1578-1584 ◽  
Author(s):  
Joanna Shim ◽  
Gareth T Jones ◽  
Ejaz M I Pathan ◽  
Gary J Macfarlane
Keyword(s):  
Biological Therapy ◽  
Axial Spondyloarthritis ◽  
Meta Analysis ◽  
Work Productivity ◽  
Work Outcomes ◽  
British Society ◽  
Activity Impairment ◽  
Work Impairment ◽  
Biologics Register

ObjectivesTo quantify, among patients with axial spondyloarthritis (axSpA), the benefit on work outcomes associated with commencing biologic therapy.MethodsThe British Society for Rheumatology Biologics Register in Axial Spondyloarthritis (BSRBRAS) recruited patients meeting Assessment of SpondyloArthritis International Society criteria for axSpA naïve to biological therapy across 83 centres in Great Britain. Work outcomes (measured using the Work Productivity and Activity Impairment Index) were compared between those starting biological therapy at the time of recruitment and those not. Differences between treatment groups were adjusted using propensity score matching. Results from BSRBR-AS were combined with other studies in a meta-analysis to calculate pooled estimates.ResultsOf the 577 participants in this analysis who were in employment, 27.9% were starting biological therapy at the time of recruitment. After propensity score adjustment, patients undergoing biological therapy, at 12-month follow-up, experienced significantly greater improvements (relative to non-biological therapy) in presenteeism (−9.4%, 95% CI −15.3% to –3.5%), overall work impairment (−13.9%, 95% CI −21.1% to –6.7%) and overall activity impairment (−19.2%, 95% CI −26.3% to –12.2%). There was no difference in absenteeism (−1.5%, 95% CI −8.0 to 4.9). Despite these improvements, impact on work was still greater in the biological treated cohort at follow-up. In the meta-analysis including 1109 subjects across observational studies and trials, treatment with biological therapy was associated with significantly greater improvements in presenteeism, work impairment and activity impairment, but there was no difference in absenteeism.ConclusionsThere is consistent evidence that treatment with biological therapy significantly improves work productivity and activity impairment in people with axSpA. However, there remain substantial unmet needs in relation to work.

scholarly journals Work Productivity is Associated With Disease Activity and Functional Ability in Chinese Patients With Axial Spondyloarthritis Using A Smart-Phone Management System: A Prospective Cohort Study

2020 ◽  
Author(s):  
Yanyan Wang ◽  
Xiaofei Liu ◽  
Wenji Chen ◽  
Shiyan Mo ◽  
Xiaojian Ji ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Work Disability ◽  
Global Assessment ◽  
Clinical Characteristics ◽  
Axial Spondyloarthritis ◽  
Work Productivity ◽  
Smart Phone ◽  
Activity Impairment ◽  
Work Impairment

Abstract Background: Axial spondyloarthritis usually affects young people and often leads to disability. We used the interactive mobile health tool to evaluate clinical characteristics and loss of work efficiency in China, and to analyze the association between the clinical characteristics and work disability in patients with axial spondyloarthritis.Methods: In total, 1187 patients with axial spondyloarthritis were included. Demographic properties, pharmacotherapy, disease activity, functionality and spinal mobility were studied and compared in both work disability and non- work disability patients. Logistic regressions were used to investigate the associations between the risk of work disability and clinical characteristics. The relationships between Work Productivity and Activity Impairment scores and clinical characteristics were assessed using Spearman correlation coefficients. Results: Of the participants, 60 or 5.05% were unemployed. The predictive factors for the occurrence of work disability were suffering from inflammatory bowel disease, higher Physician’s global assessment and higher Assessment of Spondyloarthritis International Society health index (ASASHI) scores (OR value was 3.35, 1.32 and 1.45 respectively). Absenteeism, presenteeism, overall work impairment and activity impairment in all employed patients were 10.40%, 23.53%, 30.57% and 25.35% respectively. Factors significantly associated with higher presenteeism, overall work impairment and activity impairment loss were Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score, ASASHI, nocturnal pain, total back pain, and Patient’s global assessment (r >0.5), while non-steroidal anti-inflammatory drugs treatment were significantly associated with a lower absenteeism loss. An increased ASDAS score was related to a decrease in work productivity.Conclusions: We used a Smart-Phone Management System to determine that axial spondyloarthritis had a significant influence on working conditions in China, and that the factors related to the disease had a significant correlation with the risk and severity of lost work productivity. SpAMS is found be a time- and cost-saving disease management tool which can help patients with AS independently manage their disease and provide valuable data to their clinicians.

Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis

2015 ◽  
Vol 42 (10) ◽  
pp. 1869-1877 ◽  
Author(s):  
Natalia de Oliva Spolidoro Paschoal ◽  
Jamil Natour ◽  
Flavia S. Machado ◽  
Hilda Alcântara Veiga de Oliveira ◽  
Rita Nely Vilar Furtado
Keyword(s):  
Adverse Effects ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Hand Function ◽  
Intraarticular Injection ◽  
Pinch Strength ◽  
Hand Osteoarthritis ◽  
Triamcinolone Hexacetonide ◽  
Link Type ◽  
Pain At Rest

Objective.To evaluate the effectiveness and tolerance of intraarticular injection (IAI) of triamcinolone hexacetonide (TH) for the treatment of osteoarthritis (OA) of hand interphalangeal (IP) joints.Methods.Sixty patients who underwent IAI at the most symptomatic IP joint were randomly assigned to receive TH/lidocaine (LD; n = 30) with TH 20 mg/ml and LD 2%, or just LD (n = 30). The injected joint was immobilized with a splint for 48 h in both groups. Patients were assessed at baseline and at 1, 4, 8, and 12 weeks by a blinded observer. The following variables were assessed: pain at rest [visual analog scale (VAS)r], pain at movement (VASm), swelling (physician VASs), goniometry, grip and pinch strength, hand function, treatment improvement, daily requirement of paracetamol, and local adverse effects. The proposed treatment (IAI with TH/LD) was successful if statistical improvement (p < 0.05) was achieved in at least 2 of 3 VAS. Repeated-measures ANOVA test was used to analyze intervention response.Results.Fifty-eight patients (96.67%) were women, and the mean age was 60.7 years (± 8.2). The TH/LD group showed greater improvement than the LD group for VASm (p = 0.014) and physician VASs (p = 0.022) from the first week until the end of the study. In other variables, there was no statistical difference between groups. No significant adverse effects were observed.Conclusion.The IAI with TH/LD has been shown to be more effective than the IAI with LD for pain on movement and joint swelling in patients with OA of the IP joints. Regarding pain at rest, there was no difference between groups. Trial registration number: ClinicalTrials.gov (NCT02102620).

Loss of Work Productivity and Quality of Life in Patients With Autoimmune Bullous Dermatoses

2015 ◽  
Vol 19 (6) ◽  
pp. 546-554 ◽  
Author(s):  
K. Heelan ◽  
S. L. Hitzig ◽  
S. Knowles ◽  
A. M. Drucker ◽  
N. Mittmann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Life Quality ◽  
Work Productivity ◽  
Activity Impairment ◽  
Work Impairment ◽  
Life Quality Index ◽  
The Impact

Background: Little is known about quality of life and work productivity in autoimmune bullous dermatoses (AIBDs). Objective: To determine the impact of AIBDs on quality of life and work productivity. Methods: An observational cross-sectional study took place between February and May 2013 at an AIBD tertiary referral centre. Ninety-four patients were included. All participants completed the Dermatology Life Quality Index and the Work Productivity and Activity Impairment–Specific Health Problem questionnaires. Results: Responders to treatment had less impairment ( P < .001) than nonresponders. Patients with severe AIBD had significantly more impairment that those with mild ( P < .001) and moderate ( P = .002) AIBD. Greater impairment was associated with higher percentage of work missed. Those with a higher Dermatology Life Quality Index score had greater work impairment and overall activity impairment ( P = .041, P = .024). Nonresponders had increased impairment while working ( P < .001), overall work impairment ( P < .001), and activity impairment ( P < .001). Severely affected patients had worse impairment in all Work Productivity and Activity Impairment Questionnaire domains. Conclusions: AIBD has the potential to be a large burden on ability to work and quality of life. Larger studies are needed to clarify how these domains change over time and whether or not they improve with treatment.

scholarly journals Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

2020 ◽  
Vol 12 ◽  
pp. 1759720X2094908
Author(s):  
Maria G. Tektonidou ◽  
Gkikas Katsifis ◽  
Athanasios Georgountzos ◽  
Athina Theodoridou ◽  
Eftychia-Maria Koukli ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Real World ◽  
Sleep Problems ◽  
Work Productivity ◽  
Routine Care ◽  
Activity Impairment ◽  
Work Impairment

Objective: Our aim was to evaluate the effect of adalimumab on work productivity measures, overall activity impairment, and sleep quality in patients with active moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) treated in routine care settings in Greece and determine factors associated with work impairment and sleep disturbance. Methods: Patients with active moderate to severe RA ( n = 184), PsA ( n = 166), and AS ( n = 150) were enrolled in this 24-month, prospective, observational study at 80 hospital outpatient clinics and private practices throughout Greece. Patients received adalimumab alone or in combination with standard antirheumatic therapies according to routine care. Work productivity and sleep were assessed through two patient-reported outcome measures: the Work Productivity and Activity Impairment–General Health questionnaire and the Medical Outcomes Study Sleep Scale (MOS-SS). Pearson correlation coefficients were estimated to assess the association of work impairment and sleep disturbances with disease activity scores. Results: In the overall population, adalimumab significantly lowered absenteeism [mean (95% confidence interval) reduction, 18.9% (13.3–24.5%); n = 100]; presenteeism [40.0% (33.8–46.3%); n = 98], overall work productivity impairment [46.8% (40.4–53.2%); n = 94], activity impairment [47.0% (44.3–49.6); n = 421], and the MOS-SS sleep problems index [31.6 (29.5–34.1); n = 421] after 24-month treatment ( p < 0.001). Significant improvements were also noted across the RA, PsA, and AS subpopulations ( p < 0.05). Improvements in overall work impairment and sleep disturbance positively correlated with improvements in disease activity measures. Conclusion: Adalimumab improves work productivity and sleep problems while lowering disease activity in patients with moderate to severe RA, PsA, and AS managed in real-world settings.

scholarly journals Vitamin C to pregnant smokers persistently improves infant airway function to 12 months of age: a randomised trial

2020 ◽  
Vol 56 (6) ◽  
pp. 1902208 ◽  
Author(s):  
Cindy T. McEvoy ◽  
Lyndsey E. Shorey-Kendrick ◽  
Kristin Milner ◽  
Diane Schilling ◽  
Christina Tiller ◽  
...  
Keyword(s):  
Vitamin C ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Analysis Of Covariance ◽  
Secondary Outcome ◽  
Double Blind ◽  
Smoking Cessation Counselling ◽  
Airway Function ◽  
Pregnant Smokers

BackgroundVitamin C (500 mg·day−1) supplementation for pregnant smokers has been reported to increase newborn pulmonary function and infant forced expiratory flows (FEFs) at 3 months of age. Its effect on airway function through 12 months of age has not been reported.ObjectiveTo assess whether vitamin C supplementation to pregnant smokers is associated with a sustained increased airway function in their infants through 12 months of age.MethodsThis is a pre-specified secondary outcome of a randomised, double-blind, placebo-controlled trial that randomised 251 pregnant smokers between 13 and 23 weeks of gestation: 125 to 500 mg·day−1 vitamin C and 126 to placebo. Smoking cessation counselling was provided. FEFs performed at 3 and 12 months of age were analysed by repeated-measures analysis of covariance.ResultsFEFs were performed in 222 infants at 3 months and 202 infants at 12 months of age. The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo. The overall increased flows were 40.2 mL·s−1 for at FEF75 (75% of forced vital capacity (FVC)) (adjusted 95% CI for difference 6.6–73.8; p=0.025); 58.3 mL·s−1 for FEF50 (10.9–105.8; p=0.0081); and 55.1 mL·s−1 for FEF25–75 (9.7–100.5; p=0.013).ConclusionsIn offspring of pregnant smokers randomised to vitamin C versus placebo, vitamin C during pregnancy was associated with a small but significantly increased airway function at 3 and 12 months of age, suggesting a potential shift to a higher airway function trajectory curve. Continued follow-up is underway.

scholarly journals The effects of a novel bicarbonate loading protocol on serum bicarbonate concentration: a randomized controlled trial

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Adam Marcus ◽  
Amerigo Rossi ◽  
Andrew Cornwell ◽  
Steven A. Hawkins ◽  
Nazareth Khodiguian
Keyword(s):  
Sodium Bicarbonate ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Elevated Serum ◽  
Self Report ◽  
Serum Bicarbonate ◽  
Bicarbonate Concentration ◽  
Link Type ◽  
Men 2 ◽  
Gastrointestinal Distress

Abstract Background Previous studies have shown that sodium bicarbonate ingestion may enhance intense exercise performance, but may also cause severe gastrointestinal distress. The purpose of this study was to determine whether a modified sodium bicarbonate (SB) ingestion protocol would elevate serum bicarbonate concentration more than previous methods without causing gastrointestinal distress. Methods In randomized order, seven (5 men, 2 women) elite middle-distance runners ingested either placebo, Modified SB (600 mg·kg− 1 over 19.5 h), or Acute SB (300 mg·kg− 1) in opaque gelatin capsules. Baseline and post-ingestion blood samples were analyzed for bicarbonate, pH, sodium, hematocrit, and lactate. Repeated measures ANOVA (2 time points × 3 conditions) were analyzed to determine differences in serum bicarbonate, lactate, sodium, blood pH, and hematocrit. Gastrointestinal distress was assessed via self-report on a Likert scale of 1–10. Simple (condition) and repeated (time) within-participant contrasts were used to determine the location of any statistically significant main and interaction effects (p ≤ 0.05). Results Both Modified SB (7.6 mmol·L− 1, p < 0.01) and Acute SB (5.8 mmol·L− 1, p < 0.01) increased serum bicarbonate concentration compared to the placebo (p ≤ 0.05). Post-ingestion serum bicarbonate concentration was significantly higher for the Modified SB (34.7 ± 2.2 mmol·L− 1, 28.0% increase) trials than the Acute SB (33.5 ± 2.0 mmol·L− 1, 20.9% increase) trials (p = 0.05). There was no reported severe GI distress in the Modified SB trials, but two cases in the Acute SB trials. Conclusions Modified SB elevated serum bicarbonate concentration more than Acute SB, without any severe gastrointestinal side effects. Consequently, it is recommended that future experimentation involving SB by researchers and athletes use the novel ingestion protocol described in this study due to its potential for improved effectiveness and reduced gastrointestinal impact. Trial registration ClinicalTrials.gov ,NCT03813329. Registered 23 January 2019 - Retrospectively registered,

scholarly journals TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives

2019 ◽  
Author(s):  
Robyn Su May Lim ◽  
Daphne Su Lyn Gardner ◽  
Yong Mong Bee ◽  
Yin Bun Cheung ◽  
Joann Bairavi ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Financial Incentives ◽  
Hba1c Level ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Health Utility Index ◽  
Work Productivity ◽  
Blood Glucose Monitoring ◽  
Activity Impairment

Abstract Background: Outcomes for those with Type 2 Diabetes Mellitus (T2DM) in Singapore is poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA1c levels for individuals with T2DM. Methods/Design: TRIPOD is a randomized, open-labelled, controlled, multi-center, superiority trial with three parallel arms, namely (1) usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA1c 7.5–11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms. The primary outcome is mean change in HbA1c level at Month 12 from baseline. Secondary outcomes include mean change in HbA1c level at Months 6, 18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment by Months 6, 12, 18, and 24. Incremental cost-effectiveness ratios will be computed based on costs per improvements in HbA1c at Month 12 and converted to cost per quality-adjusted life year gained. Discussion: This study will present insights about the long-term cost-effectiveness and financial viability of the interventions and the potential for integrating within usual care.

Patient-reported outcomes (PRO) in patients with metastatic breast cancer (MBC) from the VIRGO observational cohort study (OCS).

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 111-111 ◽  
Author(s):  
Peter Andrew Kaufman ◽  
Musa Mayer ◽  
Nancy A. Dreyer ◽  
Yeun Mi Yim ◽  
Elaine Yu ◽  
...  
Keyword(s):  
Sexual Interest ◽  
Locally Advanced ◽  
Work Productivity ◽  
Metastatic Breast ◽  
Symptom Burden ◽  
Activity Level ◽  
Activity Impairment ◽  
Work Impairment ◽  
Patient Reported ◽  
Related Quality

111 Background: Limited data exist on patient (pt) experience and work productivity (WP) in MBC. VIRGO is a prospective OCS following >1,200 pts with locally advanced or MBC receiving 1st-line hormonal therapy (HT) or chemotherapy (CT) in a real-world setting. We report baseline characteristics of 277 pts from the VIRGO PRO substudy and correlations between health-related quality of life (HRQoL), symptoms, activities of daily living, and WP. Methods: Symptom severity and interference (M.D. Anderson Symptom Inventory [MDASI]), functional status (Activity Level Scale [ALS] from the Rotterdam Symptom Checklist) and WP (Work Productivity and Activity Impairment Questionnaire) were assessed. Pts rated their HRQoL during the past week on a scale of 0–10. Results: See table. The five most severe symptoms at baseline were fatigue, decreased sexual interest, disturbed sleep, drowsiness, and emotional distress; these were reported with less severity in the HT cohort (24%-37% vs 42%-59%). Overall MDASI severity and interference correlated with WP measures in the CT (R=0.46 to 0.78) and HT cohorts (0.36 to 0.94). Mean of the 5 most severe symptoms also significantly correlated with WP indices (R=0.47 to 0.66). HRQoL correlated (p<0.05) with all WP measures (R=-0.46 to -0.56) in the CT cohort and with % impairment while working (R=-0.65) and % overall work impairment (R=-0.71) in the HT cohort. In univariate regression analysis, MDASI symptom interference score was the best predictor of reduced WP (R2=0.52 while working; R2=0.48 for non-work activities). Conclusions: MBC pts receiving CT and HT report significant work impairment. Results indicate moderate correlations between WP indices, HRQoL and symptom burden. [Table: see text]

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