Abstract 078: Implications of Patient-Reported Treatment Satisfaction for Discontinuation of Rivaroxaban versus Warfarin in ROCKET-AF

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Fatima Rodriguez ◽  
Leo Ungar ◽  
Anne Hellkamp ◽  
Richard C Becker ◽  
Scott D Berkowitz ◽  
...  
Keyword(s):  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Study Drug ◽  
Drug Discontinuation ◽  
Women Patients ◽  
Double Blind ◽  
Loss To Follow Up ◽  
Patient Reported ◽  
Study Drug Discontinuation

Background: Patient-reported outcomes and satisfaction are important in both trials and clinical practice and may be associated with treatment adherence. Methods: ROCKET-AF was a randomized, double-blind trial of rivaroxaban versus warfarin for prevention of thromboembolism in patients with atrial fibrillation. In a substudy, we compared treatment satisfaction scores: Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). Patient-driven discontinuation included stopping study drugs due to withdrawal of consent, non-compliance, or loss to follow-up. Rates of discontinuation were calculated for participants above and below the median scores for each scale. Results: Of 14,264 patients in ROCKET AF, 1,181 (8.3%; median age 75 years; 34% women) patients completed both the ACTS and TSQM II questionnaires 4 weeks after starting the study drug. Over a median follow-up of 1.6 years, 450 premature study drug discontinuations occurred, 116 (26%) patient-driven. Patients less satisfied with treatment by the ACTS Benefits and Burdens and TSQM II scales had higher rates of study drug discontinuation ( Table ). Conclusions: Patient-reported satisfaction was lower in patients with study drug discontinuation, suggesting that collecting patient-reported outcomes early in clinical trials may guide interventions that improve adherence and clinical outcomes.

Therapeutic care in metastatic renal cell carcinoma during the follow-up phase of the RECORD-1 phase III trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17531-e17531
Author(s):  
D. Wiederkehr ◽  
R. Casciano ◽  
L. Stern ◽  
J. Zheng ◽  
J. Baladi
Keyword(s):  
Clinical Trial ◽  
Mtor Inhibitor ◽  
Kinase Inhibitors ◽  
Study Drug ◽  
Protein Kinase Inhibitors ◽  
Phase Iii ◽  
Drug Discontinuation ◽  
Study Drug Discontinuation ◽  
Trial Setting

e17531 Background: Following drug discontinuation for progression or adverse event in a clinical trial for relapsed or stage IV kidney cancer, supportive care including surgery, palliative radiotherapy, or bisphosphonates continue to be recommended by National Comprehensive Cancer Network (NCCN). However, published data on active therapeutic agents given to patients following study drug discontinuation in recent clinical trials is limited. Methods: World Health Organization Anatomical Therapeutic Chemical codes or therapeutic names, captured from the follow-up phase in a phase III clinical trial (RECORD-1) of patients with metastatic renal cell carcinoma (mRCC) patients, were used to describe antineoplastic therapies following discontinuation of study drug. Prior to trial, patients had progressed on at least one VEGFr-TKI therapy. Results: Of the 130 patients with follow-up after discontinuation of study drug, 78.5% received at least one of the following: corticosteroids, radiotherapy, protein kinase inhibitors, mTOR inhibitor, pyrimidine analogues, monoclonal antibodies, interferons, and investigational drugs. Among patients who received an active agent, nearly three-quarters (73.5%) utilized targeted therapy (protein kinase inhibitors, mTOR inhibitor, monoclonal antibodies). Conclusions: In a clinical trial setting with mRCC patients who have received several classes of systemic therapy, care delivered following study drug discontinuation often includes an active antineoplastic agent, despite the limited supportive evidence in this setting. While the placebo control with supportive care in a double-blind phase is acceptable to evaluate the efficacy and safety of a therapy for regulatory approval purposes, decision makers must also consider how these data may inform comparisons with the usual alternatives available to and used by physicians and patients in the non-trial setting. [Table: see text]

Do Patient Demographics and Patient Reported Outcomes Predict 12-Month Loss to Follow-Up after Spine Surgery?

2014 ◽  
Vol 14 (11) ◽  
pp. S27
Author(s):  
Scott L. Parker ◽  
Saniya S. Godil ◽  
Joseph S. Cheng ◽  
Matthew J. McGirt ◽  
Clinton J. Devin
Keyword(s):  
Spine Surgery ◽  
Patient Reported Outcomes ◽  
Loss To Follow Up ◽  
Patient Demographics ◽  
Patient Reported

scholarly journals Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF

2019 ◽  
Vol 8 (2) ◽  
pp. 283-295
Author(s):  
Leo Ungar ◽  
Fatima Rodriguez ◽  
Anne S. Hellkamp ◽  
Richard C. Becker ◽  
Scott D. Berkowitz ◽  
...  
Keyword(s):  
Study Drug ◽  
Drug Discontinuation ◽  
Post Hoc Analysis ◽  
Patient Reported ◽  
Study Drug Discontinuation ◽  
Post Hoc

Do Patient Demographics and Patient-Reported Outcomes Predict 12-Month Loss to Follow-Up After Spine Surgery?

Spine ◽  
2015 ◽  
Vol 40 (24) ◽  
pp. 1934-1940 ◽  
Author(s):  
J. Alex Sielatycki ◽  
Scott L. Parker ◽  
Saniya S. Godil ◽  
Matthew J. McGirt ◽  
Clinton J. Devin
Keyword(s):  
Spine Surgery ◽  
Patient Reported Outcomes ◽  
Loss To Follow Up ◽  
Patient Demographics ◽  
Patient Reported

Patient-Reported Outcomes from Two Randomized, Double-Blind, Vehicle-Controlled Phase 3 Trials in Axillary Hyperhidrosis (ATMOS-1 & ATMOS-2)

2017 ◽  
Vol 1 ◽  
pp. s96
Author(s):  
David M Pariser ◽  
Adelaide A Hebert ◽  
Janice Drew ◽  
John Quiring ◽  
Dee Anna Glaser
Keyword(s):  
Patient Reported Outcomes ◽  
Axillary Hyperhidrosis ◽  
Phase 3 ◽  
Double Blind ◽  
Patient Reported

Abstract Not AvailableDisclosure: Study supported by Dermira.

Patient-Reported Outcomes from Two Randomized, Double-Blind, Vehicle Controlled Phase 3 Trials in Axillary Hyperhidrosis (ATMOS-1 & ATMOS-2)

2018 ◽  
Vol 2 ◽  
pp. S41
Author(s):  
David M Pariser ◽  
Adelaide A Hebert ◽  
Janice Drew ◽  
John Quiring ◽  
Dee Anna Glaser
Keyword(s):  
Patient Reported Outcomes ◽  
Axillary Hyperhidrosis ◽  
Phase 3 ◽  
Double Blind ◽  
Patient Reported

Abstract not available. Disclosures: Study supported by Dermira. Copyright SKIN 2018

Individualized cancer follow-up supported by electronic Patient-Reported Outcomes: Development and evaluation (Preprint)

2020 ◽  
Author(s):  
Sissel Ravn ◽  
Henriette Vind Thaysen ◽  
Lene Seibaek ◽  
Victor Jilbert Verwaal ◽  
Lene Hjerrild Iversen
Keyword(s):  
Ct Scan ◽  
Advanced Cancer ◽  
Patient Reported Outcomes ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
Structured Interviews ◽  
European Organization ◽  
Individualized Care ◽  
Patient Reported

BACKGROUND Cancer survivors experience unmet needs during follow-up. Besides recurrence, a follow-up includes detection of late side effects, rehabilitation, palliation and individualized care. OBJECTIVE We aimed to describe the development and evaluate the feasibility of an intervention providing individualized cancer follow-up supported by electronic patient-reported outcomes (e-PRO). METHODS The study was carried out as an interventional study at a Surgical and a Gynecological Department offering complex cancer surgery and follow-up for advanced cancer. The e-PRO screened for a priori defined clinical important symptoms and needs providing individualized follow-up. We included following questionnaires in the e-PRO; the general European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC validated for colorectal and ovarian cancer patients. To support individualization, we included three prioritized issues of the patient’s preference in each e-PRO. The response-algorithm was aggregated based on the severity of the patient’s response. To ensure the sensitivity of the e-PRO, we performed semi-structured interviews with five patients. All clinicians (surgeons and gynecologists) performing the consultations reviewed the e-PRO. The evaluation was divided in two, 1)The feasibility was assessed by a)Patients’ response rate of the e-PRO, b)Number of follow-up visits documenting the use of e-PRO and c)Patients’ prioritized issues prior to the consultation(‘yes’ / ‘no’), and after the follow-up 2)Patients assessment of a)The need and purpose of the follow-up visit and b)the support provided during the follow-up visit. RESULTS In total, 187 patients were included in the study, of which 73%(n=136/187) patients responded to the e-PRO and were subjected to an individualized follow-up. The e-PRO was documented as applied in 79% of the follow-up visits. In total, 23% of the prioritized issues did not include a response. Stratified by time since surgery, significantly more patients did not fill out a prioritized issue had a follow-up >6 months since surgery. In total, 72 % follow-up visits were evaluated to be necessary in order to discuss the outcome of the CT scan, symptoms, and/or prioritized issues. Contrary, 19% of the follow-up visits were evaluated to be necessary only to discuss the result of the CT scan. A range from 19.3–56.3% of patients assessed the follow-up visit to provide support with respect to physical (42% of patients), mental (56%), sexual (19%) or dietary (27%) issues. Further, a range from 34–60% of the patients reported that they did not need support regarding physical (43% of patients), mental (34%), sexual (63%) or dietary (57%) issues. CONCLUSIONS An individualized follow-up based on e-PRO is feasible, and support most patients surgically treated for advanced cancer. However, results indicate that follow-up based on e-PRO may not be beneficial for all patients and circumstances. A thorough cost-benefit analysis may be warranted before implementation in routine clinic.

scholarly journals Detection of adverse drug events in e-prescribing and administrative health data: a validation study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bettina Habib ◽  
Robyn Tamblyn ◽  
Nadyne Girard ◽  
Tewodros Eguale ◽  
Allen Huang
Keyword(s):  
Administrative Data ◽  
Gold Standard ◽  
Adverse Drug Events ◽  
Study Drug ◽  
Health Data ◽  
Diagnostic Code ◽  
Administrative Health Data ◽  
Potential Ades ◽  
Patient Reported

Abstract Background Administrative health data are increasingly used to detect adverse drug events (ADEs). However, the few studies evaluating diagnostic codes for ADE detection demonstrated low sensitivity, likely due to narrow code sets, physician under-recognition of ADEs, and underreporting in administrative data. The objective of this study was to determine if combining an expanded ICD code set in administrative data with e-prescribing data improves ADE detection. Methods We conducted a prospective cohort study among patients newly prescribed antidepressant or antihypertensive medication in primary care and followed for 2 months. Gold standard ADEs were defined as patient-reported symptoms adjudicated as medication-related by a clinical expert. Potential ADEs in administrative data were defined as physician, ED, or hospital visits during follow-up for known adverse effects of the study medication, as identified by ICD codes. Potential ADEs in e-prescribing data were defined as study drug discontinuations or dose changes made during follow-up for safety or effectiveness reasons. Results Of 688 study participants, 445 (64.7%) were female and mean age was 64.2 (SD 13.9). The study drug for 386 (56.1%) patients was an antihypertensive, and for 302 (43.9%) an antidepressant. Using the gold standard definition, 114 (16.6%) patients experienced an ADE, with 40 (10.4%) among antihypertensive users and 74 (24.5%) among antidepressant users. The sensitivity of the expanded ICD code set was 7.0%, of e-prescribing data 9.7%, and of the two combined 14.0%. Specificities were high (86.0–95.0%). The sensitivity of the combined approach increased to 25.8% when analysis was restricted to the 27% of patients who indicated having reported symptoms to a physician. Conclusion Combining an expanded diagnostic code set with e-prescribing data improves ADE detection. As few patients report symptoms to their physician, higher detection rates may be achieved by collecting patient-reported outcomes via emerging digital technologies such as patient portals and mHealth applications.

Sign in / Sign up

Export Citation Format

Share Document