scholarly journals Thresholds of patient-reported outcomes that define the patient acceptable symptom state in ankylosing spondylitis vary over time and by treatment and patient characteristics

2010 ◽  
Vol 62 (6) ◽  
pp. 826-834 ◽  
Author(s):  
Walter P. Maksymowych ◽  
Katherine Gooch ◽  
Maxime Dougados ◽  
Robert L. Wong ◽  
Naijun Chen ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Patient Characteristics ◽  
Patient Reported ◽  
Patient Acceptable Symptom State ◽  
Over Time

scholarly journals POS0919 BIMEKIZUMAB SHOWS SUSTAINED LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN ANKYLOSING SPONDYLITIS: 3-YEAR RESULTS FROM A PHASE 2B STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 720.2-721
Author(s):  
X. Baraliakos ◽  
M. Dougados ◽  
K. Gaffney ◽  
R. Sengupta ◽  
M. Magrey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Spinal Pain ◽  
Research Support ◽  
Sf 36 ◽  
Patient Reported ◽  
Full Analysis

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma

scholarly journals Prospective, Randomized, Comparative Study of the Cutaneous Effects of a Topical Body Treatment Compared to a Bland Moisturizer

2021 ◽  
Author(s):  
Jean Carruthers ◽  
Gyasi Bourne ◽  
Michaela Bell ◽  
Alan Widgerow
Keyword(s):  
Patient Reported Outcomes ◽  
Skin Thickness ◽  
Skin Rejuvenation ◽  
Recoil Velocity ◽  
Thickness Skin ◽  
Patient Reported ◽  
Skin Retraction ◽  
Topical Treatments ◽  
Over Time

Abstract Background Over time human skin thins and loses elasticity, and topical treatments attempt to reverse this process. Objectives Assess the efficacy of TransFORM Body Treatment (TFB) in skin rejuvenation compared to a bland moisturizer on the extensor and volar forearms. Methods Blinded participants were given two products to apply on the designated forearms with follow-up at 4, 8 and 12 weeks. Measurements included skin thickness, photography, dermatopathology, cutaneous elasticity by two separate devices, and patient reported outcomes. All were compared to baseline. Results Change in roughness: extensor -0.09 mm for bland moisturizer and -0.26 mm for TFB (P = 0.174); volar 0.01mm for bland moisturizer and -0.23 mm for TFB (P = 0.004). Change in recoil velocity: volar -56 degree/s for bland moisturizer and -24 degree/s for TFB (p = 0.61); extensor -95 degree/s for bland moisturizer and -63 degree/s for TFB (p = 0.57). Change in retraction speed: volar -3.25 ms for bland moisturizer and -20.08 ms for TFB (p = 0.33); extensor -2.17 ms for bland moisturizer and -10.83 ms for TFB (p = 0.66). Histology: TFB showed an increase in mucopolysaccharide content, new collagen and increase in elastin fibers in the papillary dermis. Change in Rao-Goldman score: volar -0.17 for bland moisturizer and -0.33 for TFB (p = 0.25); extensor -0.08 for bland moisturizer and -0.17 for TFB (p = 0.36). Conclusions Histology showed production of new collagen and elastin. Quantification of changes using skin thickness, skin retraction speed and skin recoil velocity showed trends that agree with the visual data.

Patient-reported outcomes in capmatinib-treated patients with METex14-mutated advanced NSCLC: Results from the phase II GEOMETRY mono-1 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9056-9056
Author(s):  
Juergen Wolf ◽  
Edward B. Garon ◽  
Harry J.M. Groen ◽  
Daniel Shao-Weng Tan ◽  
Isabelle Gilloteau ◽  
...  
Keyword(s):  
Chest Pain ◽  
Clinical Response ◽  
Patient Reported Outcomes ◽  
Day Treatment ◽  
Complete Response ◽  
Point Change ◽  
Patient Reported ◽  
Treatment Naïve ◽  
Eortc Qlq ◽  
Over Time

9056 Background: Capmatinib, a potent, selective MET inhibitor, showed substantial antitumor activity and manageable tolerability in patients with METex14-mutated advanced non-small cell lung cancer (aNSCLC) in the GEOMETRY mono-1 trial (NCT02414139). Patient-reported outcomes (PROs) from this study are reported here. Methods: GEOMETRY mono-1 enrolled patients ≥18 years with METex14-mutated or MET-amplified, ALK-negative and EGFR wild-type, treatment-naïve (1L) or pre-treated (2L+) aNSCLC, to receive capmatinib orally 400 mg bid during 21-day treatment cycles. Here we report results for patients with METex14 mutations. PROs (EORTC QLQ-C30, QLQ-LC13 and EQ-5D-5L) were collected at baseline (BL) and every 6 weeks (Wks) until end of treatment. Key PROs (in patients with BL and ≥1 post-BL value) included change from BL in QLQ-C30 global health status (GHS), QLQ-LC13 symptoms (cough, chest pain and dyspnea), and EQ-5D-5L visual analogue scale (VAS), with a ≥10-point change from BL considered clinically meaningful. Time to definitive deterioration (TTDD) in QLQ-LC13 symptoms (time from treatment initiation to first date of ≥10% symptom change from BL with no later reduction) was assessed using Kaplan-Meier. QLQ-LC13 symptoms over time were explored by BIRC-assessed clinical response to capmatinib. Results: By Jan 6, 2020 cut-off, median capmatinib exposure was 48.2 (4.0 117.4) Wks and 22.1 (0.4 136.0) Wks for 1L and 2L+ patients, respectively. A total of 27/28 1L patients and 65/69 2L+ patients completed PROs at BL, and completion rate remained high (mostly > 70%) through treatment cycles. Mean [SD] BL PRO scores were moderate-to-high in 1L and 2L+ patients (GHS: 64.7 [21.6] and 58.8 [21.0.]; cough: 35.9 [32.6] and 28.7 [28.2]; chest pain: 12.8 [23.2] and 17.2 [22.7]; dyspnea: 23.5 [23.4] and 22.2 [20.8]; VAS: 67.7 [20.8] and 61.9 [18.8], respectively). Overall change from BL in PROs was maintained over time. Cough improved early, with meaningful improvements observed through cycles, notably in 1L patients (mean change from BL [SD] at Wk 7: 1L -13.0 [39.9], 2L+ -8.2 [28.4]; Wk 25: 1L -15.6 [33.0], 2L+ -6.0 [31.5]; Wk 43: 1L -28.2 [26.7], 2L+ -10.5 [27.3]). Median TTDD in GHS was 16.6 months (95% CI: 9.7, NE [not estimated]) and 12.4 months (95% CI: 4.2, 19.4) in 1L and 2L+ patients, respectively. Median TTDD for cough and chest pain was NE in both 1L and 2L+ patients, and for dyspnea was 19.4 months (95% CI: 12.4, NE) and 22.1 months (95% CI: 9.9, NE), respectively. QLQ-LC13 symptoms improved at all cycles in patients achieving clinical complete response or partial response, while symptom worsening was seen in those with no clinical response. Conclusions: Capmatinib was associated with clinically meaningful improvements in cough, delayed time to lung symptom deterioration, and preserved QoL, supporting its use as a treatment option in patients with METex14-mutated aNSCLC. Clinical trial information: NCT02414139.

scholarly journals The Relation Between Disease Activity, Patient‐Reported Outcomes, and Grip Force Over Time in Early Rheumatoid Arthritis

2019 ◽  
Vol 1 (8) ◽  
pp. 507-515
Author(s):  
Maria Rydholm ◽  
Ingegerd Wikström ◽  
Sofia Hagel ◽  
Lennart T. H. Jacobsson ◽  
Carl Turesson
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Grip Force ◽  
Patient Reported ◽  
Over Time

scholarly journals How to Investigate the Effects of Groups on Changes in Longitudinal Patient-Reported Outcomes and Response Shift Using Rasch Models

2020 ◽  
Vol 11 ◽  
Author(s):  
Karima Hammas ◽  
Véronique Sébille ◽  
Priscilla Brisson ◽  
Jean-Benoit Hardouin ◽  
Myriam Blanchin
Keyword(s):  
Patient Reported Outcomes ◽  
Measurement Theory ◽  
Response Shift ◽  
Longitudinal Change ◽  
Measurement Occasion ◽  
Longitudinal Measurement ◽  
Shift Analysis ◽  
Patient Reported ◽  
Shift Effect ◽  
Over Time

In order to investigate patients’ experience of healthcare, repeated assessments of patient-reported outcomes (PRO) are increasingly performed in observational studies and clinical trials. Changes in PRO can however be difficult to interpret in longitudinal settings as patients’ perception of the concept being measured may change over time, leading to response shift (longitudinal measurement non-invariance) and possibly to erroneous interpretation of the observed changes in PRO. Several statistical methods for response shift analysis have been proposed, but they usually assume that response shift occurs in the same way in all individuals within the sample regardless of their characteristics. Many studies aim at comparing the longitudinal change of PRO into two groups of patients (treatment arm, different pathologies, …). The group variable could have an effect on PRO change but also on response shift effect and the perception of the questionnaire at baseline. In this paper, we propose to enhance the ROSALI algorithm based on Rasch Measurement Theory for the analysis of longitudinal PRO data to simultaneously investigate the effects of group on item functioning at the first measurement occasion, on response shift and on changes in PRO over time. ROSALI is subsequently applied to a longitudinal dataset on change in emotional functioning in patients with breast cancer or melanoma during the year following diagnosis. The use of ROSALI provides new insights in the analysis of longitudinal PRO data.

scholarly journals Participating in Complementary and Integrative Health Approaches Is Associated With Veterans’ Patient-reported Outcomes Over Time

Medical Care ◽  
2020 ◽  
Vol 58 ◽  
pp. S125-S132 ◽  
Author(s):  
A. Rani Elwy ◽  
Stephanie L. Taylor ◽  
Shibei Zhao ◽  
Michael McGowan ◽  
Dorothy N. Plumb ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Integrative Health ◽  
Patient Reported ◽  
Over Time

scholarly journals Gastrointestinal risk factors and patient‐reported outcomes of ankylosing spondylitis in Korea

2019 ◽  
Vol 23 (3) ◽  
pp. 342-349
Author(s):  
Sang‐Hoon Lee ◽  
Yong‐wook Park ◽  
Jung‐Yoon Choe ◽  
Kichul Shin ◽  
Seong‐Ryul Kwon ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Gastrointestinal Risk ◽  
Patient Reported

Enhancing community capacity to improve cancer care delivery and the effect on patient-reported outcomes, healthcare utilization and total costs of care.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6522-6522
Author(s):  
Manali I. Patel ◽  
David Ramirez ◽  
Richy Agajanian ◽  
Hilda H. Agajanian ◽  
Jay Bhattacharya ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Health Plan ◽  
Cancer Care ◽  
Patient Reported Outcomes ◽  
Care Delivery ◽  
Mean Difference ◽  
Healthcare Use ◽  
Difference In Difference ◽  
Patient Reported ◽  
Over Time

6522 Background: To curb rising expenditures and improve patient-reported outcomes (PROs), we designed an intervention with patient, caregiver, provider, and payer input. The intervention is based on prior work using a lay health worker (LHW) to assess advanced cancer patients' symptoms. In this study, we trained the LHW to refer patients to palliative care and/or behavioral health services in response to positive assessments and expanded the intervention to all cancer stages. We implemented the intervention with a health plan and a community oncology group serving elderly racially/ethnically diverse patients to test the effect on symptoms, healthcare use, and total costs. Methods: We enrolled all newly diagnosed health plan beneficiaries with solid and hematologic malignancies from 10/2016 to 11/2017 and compared outcomes to all cancer patients diagnosed in the year prior to the intervention (control arm). Our primary outcome was change in patient-reported symptoms using the Edmonton Symptom Assessment Scale and Personal Health Questionnaire-9 at baseline, 6 and 12 months post-enrollment. Secondarily, we compared 12 month healthcare use and costs. All generalized linear regression models were adjusted for age, stage, comorbidities, diagnosis, and follow-up. Results: 425 patients were in the intervention; 407 in the control. In both groups, mean age was 79 years; 48% were non-Hispanic White, 43% Hispanic, 3% Black, 6% Asian/Pacific Islander; 60% had advanced stages; 28% had breast, 28% had gastrointestinal, and 10% had thoracic cancers. Intervention patients had significantly decreased symptom burden over time as compared with the control (Mean Difference: intervention (-0.77 +/- 0.28 p = 0.01) vs. control: (0.45 +/- 0.25 p = 0.06)); difference in difference: (-0.68 +/- 0.25 p = 0.007)). Depression scores also significantly decreased over time among intervention patients as compared with the control (Mean Difference: intervention (-1.10 +/- 0.38 p = 0.04)) vs control: (1.21 +/- 0.34 p = 0.01); (difference in difference: -2.03 +/- 0.3 p < 0.001)). As compared to the control arm, intervention patients had lower inpatient admissions (0.7 vs. 0.5 p = 0.01) and emergency department visits per thousand patients per year (0.6 vs. 0.42 p = 0.02), and lower median total healthcare costs ($32,270 versus $25,512 p = 0.01). Conclusions: An LHW intervention significantly improved patient-reported outcomes and the value of cancer care delivery and may be a solution to improve burdensome and costly care for patients.

Sign in / Sign up

Export Citation Format

Share Document