المؤلفون: Newton, Louise, DeLozier, Amy M, Griffiths, Philip C, Hill, Jennifer N, Hudgens, Stacie, Symonds, Tara, Gable, Jonathon C, Paik, Jim, Wyrwich, Kathleen W, Eichenfield, Lawrence F, Abetz-Webb, Linda, Silverberg, Jonathan I

المصدر: Journal of Patient-Reported Outcomes. 3(1)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Neurosciences, Chronic Pain, Clinical Research, Pain Research, Skin, Adolescents, Adults, Atopic dermatitis, Clinical outcomes assessment, Health-related quality of life, Itch, Itch NRS, Patient-reported outcomes, Skin pain, Skin pain NRS, Biomedical and clinical sciences, Health sciences

الوصف: BackgroundAtopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQoL). The study objective was to understand the patient perspective of AD burden and determine suitable patient-reported outcome (PRO) measures.MethodsThis mixed methods study involved the collection of qualitative and quantitative information from adults (≥ 18 years old) and adolescents (12 - 17 years old) with clinician-confirmed AD regarding their experiences of AD symptoms and its impact on HRQoL. The first part of the study included three stages: in-person concept elicitation (CE) interviews, a 2-week daily electronic diary (eDiary) study, and in-person cognitive debriefing (CD) interviews. An Itch numeric rating scale (NRS) (v1.0) and a Skin Pain NRS (v1.0) evaluation during CD interviews required participants to think about their 'worst' itch and 'worst' skin pain in the past 24 h. Other PRO measures allowed for psychometric testing. The second part of the study involved telephone-depth interviews (TDIs) and qualitative feedback from participants who had not participated in the CD interviews. Qualitative data were thematically analyzed. Psychometric evaluation of NRS measures was performed using eDiary data.ResultsIn the CE interviews, itch and/or itching and skin pain were the most prevalent symptoms consistently discussed by participants. Both NRS measures demonstrated strong psychometric reliability and were applicable across ages with suitable concurrent validity. During the CD interviews, some participants focused their answers on their 'average' itch/itching in the past 24 h, rather than their 'worst' itch. Some participants answered the Skin Pain NRS thinking about general pain or other types of pain, rather than skin pain specifically. Consequently, modifications to both measures addressed these issues and re-tested as paper-and-pen versions in subsequent TDIs. Itch NRS (v2.0) modifications helped participants focus on their worst itching. Most participants preferred Skin Pain NRS v2.0b, which included skin pain descriptors.ConclusionsItching and skin pain are the most important and relevant AD symptoms. The Itch NRS (v2.0) and Skin Pain NRS (v2.0b) appear to be appropriate endpoints for the assessment of itching and skin pain severity for clinical trials with adults and adolescents with AD.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/4n19z8x9Test

المؤلفون: Hudgens, Stacie, Ramage, John, Kulke, Matthew, Bergsland, Emily, Anthony, Lowell, Caplin, Martyn, Öberg, Kjell, Pavel, Marianne, Gable, Jonathon, Banks, Phillip, Yang, Qi Melissa, Lapuerta, Pablo

المصدر: Journal of Patient-Reported Outcomes. 3(1)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Digestive Diseases, Clinical Research, Clinical Trials and Supportive Activities, Rare Diseases, Oral and gastrointestinal, Carcinoid syndrome, Bowel movement frequency, Meaningful change, Biomedical and clinical sciences, Health sciences

الوصف: BACKGROUND:Carcinoid syndrome is associated with a reduced quality of life that can be attributed to symptoms such as diarrhea and fatigue as well as social and financial issues. This study was conducted to psychometrically assess meaningful change in bowel movement frequency among carcinoid syndrome patients using data from the TELESTAR clinical study. METHODS:An anchor-based approach for deriving meaningful change thresholds consisted of mapping change from baseline bowel movement frequency to other patient-reported assessments of change. These included the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) Diarrhea Symptom responders, the EORTC Gastrointestinal NET questionnaire (GI.NET21) GI Symptom responders, and reported adequate relief at Week 12 (≥ 10-point score decrease from Day 1 to Week 12). Parameters included within-group mean change from baseline to Week 12, t-tests of the change (Wilcoxon rank sum for adequate relief), and effect size. RESULTS:There were 135 carcinoid syndrome patients with a mean baseline frequency of 5.7 bowel movements a day. A distribution-based method yielded meaningful change estimates of 0.62 bowel movements a day for overall frequency and 0.83 bowel movements a day at Week 12. Anchor-based analysis indicated a large effect size among patients who reported adequate relief at Week 12 (- 1.58; n = 18; P = 0.014), the QLQ-C30 Diarrhea domain responders (- 1.24; n = 40; P

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/5xf0231gTest

المؤلفون: Parikh, Neehar D., Girvan, Allicia, Coulter, Joshua, Gable, Jonathon, Poon, Jiat Ling, Kim, Sangmi, Chatterjee, Anindya, Boeri, Marco

المساهمون: Eli Lilly and Company

المصدر: BMC Cancer ; volume 23, issue 1 ; ISSN 1471-2407

مصطلحات موضوعية: Cancer Research, Genetics, Oncology

الوصف: Background Historically, high hepatocellular carcinoma (HCC)–related mortality has been, in part, due to lack of effective therapies; however, several systemic therapies have been recently approved for HCC treatment, including regorafenib and ramucirumab. These two treatments utilize different routes of administration (four daily tablets and biweekly intravenous infusions, respectively) and have different risks of adverse events (AEs). However, we lack data on patient preferences in balancing the route of administration and risk of AEs in patients with HCC. We aimed to determine patient preferences and trade-offs for second-line treatment in patients with HCC. Methods Patients with advanced or metastatic HCC were recruited through their physicians for this study. Patient preferences were assessed by using a modified threshold technique (TT) design in which respondents were asked two direct-elicitation questions before (assuming same safety and efficacy and only varying mode of administration) and after (incorporating the safety profiles of ramucirumab and regorafenib) the TT series on seven risks of clinically relevant AEs. Results In total, of the 157 patients recruited by their physicians, 150 were eligible and consented to participate. In the first elicitation question (assuming risk and efficacy were equivalent), 61.3% of patients preferred daily tablets. However, 76.7% of patients preferred the biweekly infusion when the safety profiles of the two available second-line therapies were included. The TT analysis confirmed that preferences for oral administration were not strong enough to balance out the risk of AEs that differentiate the two therapies. Discussion We found that when patients were asked to choose between a daily, oral medication and a biweekly IV medication for HCC, they were more likely to choose a daily, oral medication if efficacy and safety profiles were the same. However, when risks of AEs representing the safety profiles of two currently available second-line treatments were ...

الإتاحة: https://doi.org/10.1186/s12885-022-10388-8Test

المؤلفون: Lim, Elgene, Boyle, Frances, Okera, Meena, Loi, Sherene, Goksu, Sema Sezgin, van Hal, Gertjan, Chapman, Sonya C., Gable, Jonathon Colby, Chen, Yanyun, Price, Gregory L., Hossain, Anwar M., Gainford, M. Corona, Ezquerra, Meritxell Bellet

المساهمون: Eli Lilly and Company, University of New South Wales

المصدر: Breast Cancer Research and Treatment ; volume 195, issue 3, page 275-287 ; ISSN 0167-6806 1573-7217

مصطلحات موضوعية: Cancer Research, Oncology

الوصف: Purpose Abemaciclib, a CDK4 & 6 inhibitor, is indicated for advanced breast cancer treatment. Diarrhea is a frequently associated adverse event of abemaciclib. The study objective was to investigate if food intake impacts local gastrointestinal toxicity. Methods This Phase 2 study (I3Y-MC-JPCP, NCT03703466) randomized 72 patients 1:1:1 to receive abemaciclib 200 mg monotherapy twice daily (1) with a meal, (2) in a modified fasting state or (3) without regard to food. Primary endpoints included: incidence of investigator assessed severe (≥ Grade 3), prolonged (> 7 days) Grade 2 diarrhea, treatment discontinuation, dose modifications, and loperamide utilization during the first 3 cycles of treatment. Patient outcomes were captured via a daily electronic diary. Pharmacokinetics (PK) are reported. Results Incidence of investigator assessed severe diarrhea (Grade ≥ 3) was 1.4% (1 patient in Arm 1). Median duration of Grade 3 diarrhea was 1 day by both investigator assessment (1 patient in Arm 1) and patient-reported assessment (1 patient each in Arms 1 and 3). Median duration of investigator-assessed Grade 2 diarrhea was 2 days overall. No patient discontinued treatment due to diarrhea. Nine patients (12.7%) had a dose reduction, and 7 patients (9.9%) had a dose omission due to diarrhea. Ninety-four percent of patients used loperamide at least once. Abemaciclib PK was comparable across the 3 arms. Conclusion The results suggest that diarrhea incidence associated with abemaciclib was unrelated to timing of food intake, was predominantly low grade, of short duration and well managed with loperamide and dose modifications.

الإتاحة: https://doi.org/10.1007/s10549-022-06690-5Test

المؤلفون: Stephenson, Judith J, Gable, Jonathon Colby, Zincavage, Rebekah, Price, Gregory L, Churchill, Collin, Zhu, Emily, Stenger, Keri, Singhal, Mukul, Nepal, Bal, Grabner, Michael, Fisch, Michael J, Debono, David, Geschwender, Amy R, Cuyun Carter, Gebra

المصدر: Patient Preference and Adherence ; volume Volume 15, page 2417-2429 ; ISSN 1177-889X

الإتاحة: https://doi.org/10.2147/ppa.s319239Test
https://www.dovepress.com/getfile.php?fileID=75500Test

المؤلفون: Zhu, Andrew X., Nipp, Ryan D., Finn, Richard S., Galle, Peter R., Llovet i Bayer, Josep Maria, Blanc, Jean Frederic, Okusaka, Takuji, Chau, Ian, Cella, David, Girvan, Alicia, Gable, Jonathon, Bowman, Lee, Wang, Chunxiao, Hsu, Yanzhi, Abada, Paolo, Kudo, Masatoshi

المصدر: Articles publicats en revistes (Medicina)

مصطلحات موضوعية: Càncer de fetge, Qualitat de vida, Liver cancer, Quality of life

الوصف: Background: Symptoms of advanced hepatocellular carcinoma (HCC) represent a substantial burden for the patient and are important endpoints to assess when evaluating treatment. Patient-reported outcomes were evaluated in subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400 ng/mL treated with second-line ramucirumab. Patients and methods: Patients with AFP≥400 ng/mL enrolled in the REACH or REACH-2 phase 3 studies were used in this analysis. Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib. Patients received ramucirumab 8 mg/kg or placebo once every 2 weeks. Disease-related symptoms and health-related quality of life (HRQoL) were assessed with the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D) instruments, respectively. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score;≥0.06-point decrease in EQ-5D score, from randomisation to first date of deterioration) was determined using Kaplan-Meier estimation and the Cox proportional hazards model. Both separate and pooled analyses for REACH AFP≥400 ng/mL and REACH-2 patients were conducted. Results: In the pooled population with AFP ≥400 ng/mL (n=542; ramucirumab, n=316; placebo, n=226), median TTD in FHSI-8 total score was prolonged with ramucirumab relative to placebo (3.3 vs 1.9 months; HR 0.725; (95% CI 0.559 to 0.941); p=0.0152), including significant differences in back pain (0.668; (0.497 to 0.899); p=0.0044), weight loss (0.699; (0.505 to 0.969); p=0.0231) and pain (0.769; (0.588 to 1.005); p=0.0248) symptoms. TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months). Results in the individual trials were consistent with these findings. Conclusions: Ramucirumab in second-line treatment of advanced HCC demonstrates consistent benefit in the delay of deterioration in disease-related symptoms with no worsening of HRQoL. Taken with ...

وصف الملف: 9 p.; application/pdf

العلاقة: Reproducció del document publicat a: https://doi.org/10.1136/esmoopen-2020-000797Test; Esmo Open, 2020, vol. 5, num. 4, p. e000797; https://doi.org/10.1136/esmoopen-2020-000797Test; http://hdl.handle.net/2445/178116Test; 706131

الإتاحة: https://doi.org/10.1136/esmoopen-2020-000797Test
http://hdl.handle.net/2445/178116Test

المؤلفون: Parikh, Neehar D., Girvan, Allicia, Coulter, Joshua, Gable, Jonathon, Poon, Jiat Ling, Kim, Sangmi, Chatterjee, Anindya, Boeri, Marco

الوصف: Additional file 1: Table S1. Summary of Respondents’ Experience with Hepatocellular Carcinoma Treatments. Table S2. Results of Covariate-Adjusted Threshold Model: Tablet Sample (N = 92). Table S3. Results of Covariate-Adjusted Threshold Model: Intravenous Infusion Sample (N = 58). Figure S1. Threshold Question Sequence for Risk of Decreased Appetite if “Four Tablets” is Initially Preferred. Figure S2. Threshold Question Sequence for Risk of Hand-Foot Skin Reaction if “Four Tablets” is Initially Preferred. Figure S3. Threshold Question Sequence for Risk of Diarrhea if “Four Tablets” is Initially Preferred. Figure S4. Threshold Question Sequence for Risk of Ascites if “Four Tablets” is Initially Preferred. Figure S5. Threshold Question Sequence for Risk of Proteinuria if “Four Tablets” is Initially Preferred. Figure S6. Threshold Question Sequence for Risk of Peripheral Edema if “Four Tablets” is Initially Preferred. Figure S7. Threshold Question Sequence for Risk of Hypertension if Intravenous Infusion is Initially Preferred. Figure S8. Threshold Question Sequence for Risk of Decreased Appetite if Intravenous Infusion is Initially Preferred. Figure S9. Threshold Question Sequence for Risk of Hand-Foot Skin Reaction if Intravenous Infusion is Initially Preferred. Figure S10. Threshold Question Sequence for Risk of Diarrhea if Intravenous Infusion is Initially Preferred. Figure S11. Threshold Question Sequence for Risk of Ascites if Intravenous Infusion is Initially Preferred. Figure S12. Threshold Question Sequence for Risk of Proteinuria if Intravenous Infusion is Initially Preferred. Figure S13. Threshold Question Sequence for Risk of Peripheral Edema if Intravenous Infusion is Initially Preferred. Figure S14. Minimum Reduction in Risk of Hypertension to Switch From Tablets Every Day to Intravenous Infusion Every 2 Weeks. Figure S15. Minimum Reduction in Risk of Decreased Appetite to Switch From Tablets Every Day to Intravenous Infusion Every 2 Weeks. Figure S16. Minimum Reduction in Risk of Hand-Foot Skin Reaction to Switch From Tablets Every Day to Intravenous Infusion Every 2 Weeks. Figure S17. Minimum Reduction in Risk of Diarrhea to Switch From Tablets Every Day To Intravenous Infusion Every 2 Weeks. Figure S18. Minimum Reduction in Risk of Ascites to Switch From Tablets Every Day to Intravenous Infusion Every 2 Weeks. Figure S19. Minimum Reduction in Risk of Proteinuria to Switch From Tablets Every Day to Intravenous Infusion Every 2 Weeks. Figure S20. Minimum Reduction in Risk of Peripheral Edema to Switch From Tablets Every Day to Intravenous Infusion Every 2 Weeks. Figure S21. Maximum Increase in Risk of Hypertension to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day. Figure S22. Maximum Increase in Risk of Lower Appetite to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day. Figure S23. Maximum Increase in Risk of Hand-foot Reaction to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day. Figure S24. Maximum Increase in Risk of Diarrhea to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day. Figure S25. Maximum Increase in Risk of Ascites to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day. Figure S26. Maximum Increase in Risk of Proteinuria to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day. Figure S27. Maximum Increase in Risk of Peripheral Edema to Keep Intravenous Infusion Every 2 Weeks Instead of Switching to Tablets Every Day.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3c7f48d4b5f25bddd4e1e683d72e4202Test

المؤلفون: Brown, Sacha D., Furrow, David, Hill, Daniel F., Gable, Jonathon C., Porter, Liam P., Jacobs, W. Jake

المصدر: Perspectives on Psychological Science, 2014 Nov 01. 9(6), 626-640.

الوصول الحر: http://www.jstor.org/stable/44290169Test

المؤلفون: Figueredo, Aurelio José, Garcia, Rafael Antonio, Cabeza de Baca, Tomás, Gable, Jonathon Colby, Weise, Dave

المصدر: Journal of Methods and Measurement in the Social Sciences; Vol 4, No 1 (2013); 1-19 ; 2159-7855

مصطلحات موضوعية: Mediation, Indirect Effects, Causal Steps Approach, Cascade Model, Sequential Canonical Analysis

الوصف: The process of mediation is of critical importance to the social and behavioral sciences and to evolutionary social psychology in particular. As with the concept of evolutionary adaptation, however, one can argue that causal mediation is in need of explicit theoretical justification and empirical support. Mainstream evolutionary social psychology proposes, for example, that organisms are “adaptation executers”, and not “fitness maximizers”. The execution of adaptations is triggered by fitness-relevant ecological contingencies at both ultimate and proximate levels of analysis. This logic is essentially equivalent to what methodologists refer to as the process of mediation; the adaptations to be executed (or not, depending upon the prevailing environmental circumstances) causally mediate the effects of the ecological contingencies upon the fitness outcomes. Thus, the process of mediation can be generally conceptualized as a causal chain of events leading to a given outcome or set of outcomes. If a predictor variable operates through an intervening variable to affect a criterion variable, then mediation is said to exist. Nevertheless, it does not appear that some psychologists (particularly evolutionary-social psychologists) are sufficiently well-versed in the fundamental logic and quantitative methodology of establishing causal mediation to support such claims. In the current paper, we set out to review the ways researchers support their use of mediation statements and also propose critical considerations on this front. We start with more conventional methods for testing mediation, discuss variants of the conventional approach, discuss the limitations of such methods as we see them, and end with our preferred mediation approach. DOI:10.2458/azu_jmmss_v04i1_figueredo3

وصف الملف: application/pdf

العلاقة: https://journals.uair.arizona.edu/index.php/jmmss/article/view/17761/17484Test; https://journals.uair.arizona.edu/index.php/jmmss/article/view/17761Test

الإتاحة: https://doi.org/10.2458/v4i1.17761Test
https://journals.uair.arizona.edu/index.php/jmmss/article/view/17761Test