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      Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study

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          Abstract

          Background

          Numerous antineoplastic drugs such as chemotherapeutics have cardiotoxic side effects and can lead to long QT syndrome (LQTS). When diagnosed and treated in time, the potentially fatal outcomes of LQTS can be prevented. Therefore, regular electrocardiogram (ECG) assessments are critical to ensure patient safety. However, these assessments are associated with patient discomfort and require timely support of the attending oncologist by a cardiologist.

          Objective

          This study aimed to examine whether this approach can be made more efficient and comfortable by a smartphone app (QTc Tracker), supporting single-lead ECG records on site and transferring to a tele-cardiologist for an immediate diagnosis.

          Methods

          To evaluate the QTc Tracker, it was implemented in 54 cancer centers in Germany. In total, 266 corrected QT interval (QTc) diagnoses of 122 patients were recorded. Moreover, a questionnaire on routine ECG workflow, turnaround time, and satisfaction (1=best, 6=worst) was answered by the centers before and after the implementation of the QTc Tracker.

          Results

          Compared to the routine ECG workflow, the QTc Tracker enabled a substantial turnaround time reduction of 98% (mean 2.67, 95% CI 1.72-2.67 h) and even further time efficiency in combination with a cardiologic on-call service (mean 12.10, 95% CI 5.67-18.67 min). Additionally, nurses and patients reported higher satisfaction when using the QTc Tracker. In particular, patients’ satisfaction sharply improved from 2.59 (95% CI 2.41-2.88) for the routine ECG workflow to 1.25 (95% CI 0.99-1.51) for the QTc Tracker workflow.

          Conclusions

          These results reveal a significant improvement regarding reduced turnaround time and increased user satisfaction. Best patient care might be guaranteed as the exposure of patients with an uncontrolled risk of QTc prolongations can be avoided by using the fast and easy QTc Tracker. In particular, as regular side-effect monitoring, the QTc Tracker app promises more convenience for patients and their physicians. Finally, future studies are needed to empirically test the usability and validity of such mobile ECG assessment methods.

          Trial Registration

          ClinicalTrials.gov NCT04055493; https://classic.clinicaltrials.gov/ct2/show/NCT04055493

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          Most cited references48

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          2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines:  The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC).

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            Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial.

            There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC (ClinicalTrials.gov NCT00410761).
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              Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial

              In MONALEESA-2, ribociclib plus letrozole showed improved progression-free survival compared with letrozole alone as first-line treatment for postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer. MONALEESA-7 aimed to assess the efficacy and safety of ribociclib plus endocrine therapy in premenopausal women with advanced, HR-positive breast cancer.
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                Author and article information

                Contributors
                Journal
                JMIR Cardio
                JMIR Cardio
                JCARD
                JMIR Cardio
                JMIR Publications (Toronto, Canada )
                2561-1011
                2023
                11 September 2023
                : 7
                : e48096
                Affiliations
                [1 ] Institute of Sport Science University of the Bundeswehr Munich Neubiberg Germany
                [2 ] CANKADO GmbH Ottobrunn Germany
                [3 ] Research Center for Smart Digital Health University of the Bundeswehr Munich Neubiberg Germany
                [4 ] Department of Gynecology and Obstetrics Comprehensive Cancer Center of the Ludwig-Maximilians-University Munich Germany
                Author notes
                Corresponding Author: Annette Schmidt annette.schmidt@ 123456unibw.de
                Author information
                https://orcid.org/0000-0002-6906-9933
                https://orcid.org/0009-0007-3060-6950
                https://orcid.org/0000-0002-2008-6775
                https://orcid.org/0000-0002-9744-7372
                https://orcid.org/0000-0002-2315-6417
                Article
                v7i1e48096
                10.2196/48096
                10520775
                37695655
                bba90169-8542-463a-bc04-94d52e4474e8
                ©Kristina Klier, Yash J Patel, Timo Schinköthe, Nadia Harbeck, Annette Schmidt. Originally published in JMIR Cardio (https://cardio.jmir.org), 11.09.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Cardio, is properly cited. The complete bibliographic information, a link to the original publication on https://cardio.jmir.org, as well as this copyright and license information must be included.

                History
                : 11 April 2023
                : 30 May 2023
                : 20 June 2023
                : 21 June 2023
                Categories
                Original Paper
                Original Paper

                telemedicine,mobile health,mhealth,ehealth,tele-cardiology,cardiology,long qt syndrome,prolonged qt interval,electrocardiography,ecg,telehealth,app,application,oncology,cancer,diagnosis,diagnostic,heart,arrhythmia,cardiotoxic,side effects,adverse effects

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