Publications by authors named "Guenter Schreier"

13 Publications

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Trials and Tribulations: mHealth Clinical Trials in the COVID-19 Pandemic.

Yearb Med Inform 2021 Apr 21. Epub 2021 Apr 21.

Graduate School of Biomedical Engineering, The University of New South Wales, Sydney, Australia.

Introduction: Mobile phone-based interventions in cardiovascular disease are growing in popularity. A randomised control trial (RCT) for a novel smartphone app-based model of care, named TeleClinical Care - Cardiac (TCC-Cardiac), commenced in February 2019, targeted at patients being discharged after care for an acute coronary syndrome or episode of decompensated heart failure. The app was paired to a digital sphygmomanometer, weighing scale and a wearable fitness band, all loaned to the patient, and allowed clinicians to respond to abnormal readings. The onset of the COVID-19 pandemic necessitated several modifications to the trial in order to protect participants from potential exposure to infection. The use of TCC-Cardiac during the pandemic inspired the development of a similar model of care (TCC-COVID), targeted at patients being managed at home with a diagnosis of COVID-19.

Methods: Recruitment for the TCC-Cardiac trial was terminated shortly after the World Health Organization announced COVID-19 as a global pandemic. Telephone follow-up was commenced, in order to protect patients from unnecessary exposure to hospital staff and patients. Equipment was returned or collected by a 'no-contact' method. The TCC-COVID app and model of care had similar functionality to the original TCC-Cardiac app. Participants were enrolled exclusively by remote methods. Oxygen saturation and pulse rate were measured by a pulse oximeter, and symptomatology measured by questionnaire. Measurement results were manually entered into the app and transmitted to an online server for medical staff to review.

Results: A total of 164 patients were involved in the TCC-Cardiac trial, with 102 patients involved after the onset of the pandemic. There were no hospitalisations due to COVID-19 in this cohort. The study was successfully completed, with only three participants lost to follow-up. During the pandemic, 5 of 49 (10%) of patients in the intervention arm were readmitted compared to 12 of 53 (23%) in the control arm. Also, in this period, 28 of 29 (97%) of all clinically significant alerts received by the monitoring team were managed successfully in the outpatient setting, avoiding hospitalisation. Patients found the user experience largely positive, with the average rating for the app being 4.56 out of 5. 26 patients have currently been enrolled for TCC-COVID. Recruitment is ongoing. All patients have been safely and effectively monitored, with no major adverse clinical events or technical malfunctions. Patient satisfaction has been high.

Conclusion: The TCC-Cardiac RCT was successfully completed despite the challenges posed by COVID-19. Use of the app had an added benefit during the pandemic as participants could be monitored safely from home. The model of care inspired the development of an app with similar functionality designed for use with patients diagnosed with COVID-19.
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http://dx.doi.org/10.1055/s-0041-1726487DOI Listing
April 2021

Investigation of the Role of Dinutuximab Beta-Based Immunotherapy in the SIOPEN High-Risk Neuroblastoma 1 Trial (HR-NBL1).

Cancers (Basel) 2020 Jan 28;12(2). Epub 2020 Jan 28.

Department of Pediatric Hematology and Oncology, University Medicine Greifswald, 17489 Greifswald, Germany.

To explore the effects of immunotherapy in the International Society of Paediatric Oncology Europe Neuroblastoma Group SIOPEN high-risk neuroblastoma 1 trial (HR-NBL1 trial), two cohorts were studied: one prior to and one after the introduction of dinutuximab beta. All patients received standard induction and high-dose therapy (HDT) with autologous stem cell rescue (ASCR); the local control comprised surgery and radiotherapy to the primary tumour site, followed by isotretinoin. A landmark timepoint of 109 days, resulting from the median time between ASCR and initiation of immunotherapy, was used to define patients' eligibility in the pre-immunotherapy analysis cohort. Median follow-up was 5.8 years (inter-quartile range (IQR): 4.2-8.2 years) for 844 eligible patients balanced for risk factors, such as age, sex, stage 4, MYCN amplification and response prior to HDT. The five-year event-free and overall survival (95% confidence interval (CI) of 466 patients not receiving immunotherapy was 42% (38-47%) and 50% (46-55%) but was 57% (51-62%) and 64% (59-69%) for 378 patients receiving immunotherapy ( < 0.001). A multivariate analysis identified absence of immunotherapy (p = 0.0002, hazard ratio (HR) 1.573); type of HDT ( = 0.0029, HR 1.431); less than complete response prior to maintenance therapy ( = 0.0043, HR 1.494) and >1 metastatic compartment at diagnosis ( < 0.001, HR 2.665) as risk factors for relapse or progression. Results suggest an important role for dinutuximab beta-based immunotherapy within the treatment concepts applied in HR-NBL1/SIOPEN.
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http://dx.doi.org/10.3390/cancers12020309DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7072500PMC
January 2020

Interleukin 2 with anti-GD2 antibody ch14.18/CHO (dinutuximab beta) in patients with high-risk neuroblastoma (HR-NBL1/SIOPEN): a multicentre, randomised, phase 3 trial.

Lancet Oncol 2018 12 12;19(12):1617-1629. Epub 2018 Nov 12.

Paediatric Haematology-Oncology Department, University Medicine Greifswald, Greifswald, Germany.

Background: Immunotherapy with the chimeric anti-GD2 monoclonal antibody dinutuximab, combined with alternating granulocyte-macrophage colony-stimulating factor and intravenous interleukin-2 (IL-2), improves survival in patients with high-risk neuroblastoma. We aimed to assess event-free survival after treatment with ch14.18/CHO (dinutuximab beta) and subcutaneous IL-2, compared with dinutuximab beta alone in children and young people with high-risk neuroblastoma.

Methods: We did an international, open-label, phase 3, randomised, controlled trial in patients with high-risk neuroblastoma at 104 institutions in 12 countries. Eligible patients were aged 1-20 years and had MYCN-amplified neuroblastoma with stages 2, 3, or 4S, or stage 4 neuroblastoma of any MYCN status, according to the International Neuroblastoma Staging System. Patients were eligible if they had been enrolled at diagnosis in the HR-NBL1/SIOPEN trial, had completed the multidrug induction regimen (cisplatin, carboplatin, cyclophosphamide, vincristine, and etoposide, with or without topotecan, vincristine, and doxorubicin), had achieved a disease response that fulfilled prespecified criteria, had received high-dose therapy (busulfan and melphalan or carboplatin, etoposide, and melphalan) and had received radiotherapy to the primary tumour site. In this component of the trial, patients were randomly assigned (1:1) to receive dinutuximab beta (20 mg/m per day as an 8 h infusion for 5 consecutive days) or dinutuximab beta plus subcutaneous IL-2 (6 × 10 IU/m per day on days 1-5 and days 8-12 of each cycle) with the minimisation method to balance randomisation for national groups and type of high-dose therapy. All participants received oral isotretinoin (160 mg/m per day for 2 weeks) before the first immunotherapy cycle and after each immunotherapy cycle, for six cycles. The primary endpoint was 3-year event-free survival, analysed by intention to treat. This trial was registered with ClinicalTrials.gov, number NCT01704716, and EudraCT, number 2006-001489-17, and recruitment to this randomisation is closed.

Findings: Between Oct 22, 2009, and Aug 12, 2013, 422 patients were eligible to participate in the immunotherapy randomisation, of whom 406 (96%) were randomly assigned to a treatment group (n=200 to dinutuximab beta and n=206 to dinutuximab beta with subcutaneous IL-2). Median follow-up was 4·7 years (IQR 3·9-5·3). Because of toxicity, 117 (62%) of 188 patients assigned to dinutuximab beta and subcutaneous IL-2 received their allocated treatment, by contrast with 160 (87%) of 183 patients who received dinutuximab beta alone (p<0·0001). 3-year event-free survival was 56% (95% CI 49-63) with dinutuximab beta (83 patients had an event) and 60% (53-66) with dinutuximab beta and subcutaneous IL-2 (80 patients had an event; p=0·76). Four patients died of toxicity (n=2 in each group); one patient in each group while receiving immunotherapy (n=1 congestive heart failure and pulmonary hypertension due to capillary leak syndrome; n=1 infection-related acute respiratory distress syndrome), and one patient in each group after five cycles of immunotherapy (n=1 fungal infection and multi-organ failure; n=1 pulmonary fibrosis). The most common grade 3-4 adverse events were hypersensitivity reactions (19 [10%] of 185 patients in the dinutuximab beta group vs 39 [20%] of 191 patients in the dinutuximab plus subcutaneous IL-2 group), capillary leak (five [4%] of 119 vs 19 [15%] of 125), fever (25 [14%] of 185 vs 76 [40%] of 190), infection (47 [25%] of 185 vs 64 [33%] of 191), immunotherapy-related pain (19 [16%] of 122 vs 32 [26%] of 124), and impaired general condition (30 [16%] of 185 vs 78 [41%] of 192).

Interpretation: There is no evidence that addition of subcutaneous IL-2 to immunotherapy with dinutuximab beta, given as an 8 h infusion, improved outcomes in patients with high-risk neuroblastoma who had responded to standard induction and consolidation treatment. Subcutaneous IL-2 with dinutuximab beta was associated with greater toxicity than dinutuximab beta alone. Dinutuximab beta and isotretinoin without subcutaneous IL-2 should thus be considered the standard of care until results of ongoing randomised trials using a modified schedule of dinutuximab beta and subcutaneous IL-2 are available.

Funding: European Commission 5th Frame Work Grant, St. Anna Kinderkrebsforschung, Fondation ARC pour la recherche sur le Cancer.
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http://dx.doi.org/10.1016/S1470-2045(18)30578-3DOI Listing
December 2018

A small-scale randomised controlled trial of home telemonitoring in patients with severe chronic obstructive pulmonary disease.

J Telemed Telecare 2017 Aug 26;23(7):650-656. Epub 2016 Jul 26.

6 Austrian Institute of Technology, Graz, Austria.

Introduction This was a pilot study to examine the effects of home telemonitoring (TM) of patients with severe chronic obstructive pulmonary disease (COPD). Methods A randomised controlled 12-month trial of 42 patients with severe COPD was conducted. Home TM of oximetry, temperature, pulse, electrocardiogram, blood pressure, spirometry, and weight with telephone support and home visits was tested against a control group receiving only identical telephone support and home visits. Results The results suggest that TM had a reduction in COPD-related admissions, emergency department presentations, and hospital bed days. TM also seemed to increase the interval between COPD-related exacerbations requiring a hospital visit and prolonged the time to the first admission. The interval between hospital visits was significantly different between the study arms, while the other findings did not reach significance and only suggest a trend. There was a reduction in hospital admission costs. TM was adopted well by most patients and eventually, also by the nursing staff, though it did not seem to change patients' psychological well-being. Discussion Ability to draw firm conclusions is limited due to the small sample size. However the trends of reducing hospital visits warrant a larger study of a similar design. When designing such a trial, one should consider the potential impact of the high quality of care already made available to this patient cohort.
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http://dx.doi.org/10.1177/1357633X16659410DOI Listing
August 2017

Piloting the European Unified Patient Identity Management (EUPID) Concept to Facilitate Secondary Use of Neuroblastoma Data from Clinical Trials and Biobanking.

Stud Health Technol Inform 2016 ;223:31-8

AIT Austrian Institute of Technology. Digital Safety & Security Dept., Graz, Austria.

Data from two contexts, i.e. the European Unresectable Neuroblastoma (EUNB) clinical trial and results from comparative genomic hybridisation (CGH) analyses from corresponding tumour samples shall be provided to existing repositories for secondary use. Utilizing the European Unified Patient IDentity Management (EUPID) as developed in the course of the ENCCA project, the following processes were applied to the data: standardization (providing interoperability), pseudonymization (generating distinct but linkable pseudonyms for both contexts), and linking both data sources. The applied procedures resulted in a joined dataset that did not contain any identifiers that would allow to backtrack the records to either data sources. This provided a high degree of privacy to the involved patients as required by data protection regulations, without preventing proper analysis.
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April 2017

Internet of Things Based Medication Adherence Assessment.

Stud Health Technol Inform 2016 ;221:118

AIT Austrian Institute of Technology, Digital Safety & Security Dept, Graz, Austria.

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January 2017

Textual analysis of collaboration notes of the telemedical heart failure network HerzMobil Tirol.

Stud Health Technol Inform 2015 ;212:57-64

AIT Austrian Institute of Technology, Austria.

Unlabelled: Management of heart failure is usually multidisciplinary and collaboration between stakeholders in a dedicated HI network like the HerzMobil Tirol can be supported by a mHealth-based telemedicine approach. The aim is to gain insights through textual analysis of collaboration notes that might trigger further developments and improvements of the HI network. A reusable pipeline for textual analysis of unstructured textual notes was implemented using the open source analytics software KNIME. After preprocessing, a keyword analysis was performed resulting in a classification of all notes in predefined categories.

Results: Medical and organizational issues dominate the communication with health status and therapy aspects as well as clinical treatment, discharge letter and home visits. Beside aspects of data transmission and mobile phone, technological issues are minor topics during the collaboration. It is possible to gain new insights with respect to technology like additional control Apps for mobile phone settings and to the HI network like clinical experts and technical help desk involvement.
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November 2016

Feasibility of mHealth and Near Field Communication technology based medication adherence monitoring.

Annu Int Conf IEEE Eng Med Biol Soc 2012 ;2012:272-5

AIT Austrian Institute of Technology, 8020 Graz, Austria.

Poor patients' adherence to intake of prescribed medication has been identified as a serious problem in the treatment of chronically ill patients. Technical solutions are needed to measure and - if necessary - to increase the patients' adherence. A telemonitoring solution was developed to record a patient's medication intake based on smart blisters and mobile phones with NFC functionality. The components allowed recording of drug type, timestamp, and dosage of pills taken. The system's usability and technical feasibility was evaluated in the course of an application study. Over a period of 13 months 59 patients suffering from diabetes were monitored. 1,760 blisters were handed out to these patients and 14,843 takeout events were recorded and transmitted via mobile phone. Results indicate the feasibility of this concept to monitor adherence. Although the system still needs to be optimized for routine use it shows the potential for targeting the problem of poor patient adherence by NFC enabled devices.
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http://dx.doi.org/10.1109/EMBC.2012.6345922DOI Listing
August 2013

Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial.

J Med Internet Res 2009 Aug 17;11(3):e34. Epub 2009 Aug 17.

Department of Cardiology, Medical University Graz, Graz, Austria.

Background: Telemonitoring of patients with chronic heart failure (CHF) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization.

Objective: The goal of the MOBIle TELemonitoring in Heart Failure Patients Study (MOBITEL) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation.

Methods: Patients were randomly allocated to pharmacological treatment (control group) or to pharmacological treatment with telemedical surveillance for 6 months (tele group). Patients randomized into the tele group were equipped with mobile phone-based patient terminals for data acquisition and data transmission to the monitoring center. Study physicians had continuous access to the data via a secure Web portal. If transmitted values went outside individually adjustable borders, study physicians were sent an email alert. Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause.

Results: The study was stopped after randomization of 120 patients (85 male, 35 female); median age was 66 years (IQR 62-72). The control group comprised 54 patients (39 male, 15 female) with a median age of 67 years (IQR 61-72), and the tele group included 54 patients (40 male, 14 female) with a median age of 65 years (IQR 62-72). There was no significant difference between groups with regard to baseline characteristics. Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone ("never beginners"). Four patients did not finish the study due to personal reasons. Intention-to-treat analysis at study end indicated that 18 control group patients (33%) reached the primary endpoint (1 death, 17 hospitalizations), compared with 11 tele group patients (17%, 0 deaths, 11 hospitalizations; relative risk reduction 50%, 95% CI 3-74%, P = .06). Per-protocol analysis revealed that 15% of tele group patients (0 deaths, 8 hospitalizations) reached the primary endpoint (relative risk reduction 54%, 95% CI 7-79%, P= .04). NYHA class improved by one class in tele group patients only (P< .001). Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04). The event rate of never beginners was not higher than the event rate of control group patients.

Conclusions: Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations. Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept.
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http://dx.doi.org/10.2196/jmir.1252DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2762855PMC
August 2009

A Web-based platform for interdisciplinary biomedical research.

Front Biosci (Landmark Ed) 2009 Jan 1;14:2738-46. Epub 2009 Jan 1.

eHealth-systems, Biomedical Engineering, Austrian Research Centers GmbH-ARC, Graz, Austria.

The European Neuroblastoma Group of the International Society for Paediatric Oncology (SIOPEN) is dedicated to the research and treatment of neuroblastoma. The medical research network SIOPEN-R-NET is an extensive web-based European IT network for interdisciplinary biomedical research. The IT infrastructure has been built using state-of-the-art multi-tiered architecture principles. Basic features required for electronic data capture in clinical trials were implemented. Additionally, advanced tools were developed for registration, review, user management, communication and image management. Currently three clinical trials and eight supporting scientific studies are implemented. The medical research network is already in use by 345 active users from 240 institutions in 18 countries. More than 960 000 item entries and 7962 images from 1260 patients are stored. Challenges, which resulted from the fact that only 16 % of the centres had more than 2 patients per year, have been addressed by an intuitive user interface, hierarchical roles, user required features, and experienced support. The system has already been used extensively and has helped to make significant progress in the area of Neuroblastoma research.
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http://dx.doi.org/10.2741/3410DOI Listing
January 2009

A pilot study of mobile phone-based therapy for obese patients.

J Telemed Telecare 2008 ;14(3):147-9

Department of Biomedical Engineering, Division of E-health Systems, Austrian Research Centers GmbH -ARC, Graz, Austria.

We conducted a pilot study to assess the feasibility of a web-based therapy management system with mobile phone access to support obese patients. A total of 25 patients participated in the study. The mean age of the patients was 48 years. The mean body mass index of the patients at recruitment was 35.6 kg/m(2). The mean observation period was 70 days. A total of 361 successful data transmissions was performed -- the mean number of transmissions per patient was 14. The total number of outgoing reminder messages was 123, corresponding to 4.9 reminder messages per patient. At the end of the study, there were significant reductions of 2.4 cm in abdominal girth (P < 0.001), 2.4 kg in bodyweight (P < 0.001) and 0.78 kg/m(2) in body mass index (P < 0.001). In a questionnaire at the end of the study, the majority of the participants gave answers that indicated a positive attitude towards the system. The pilot study showed that mobile phones can be utilized as patient terminals for therapy in patients suffering from obesity.
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http://dx.doi.org/10.1258/jtt.2008.003015DOI Listing
October 2008

Feasibility of a mobile phone-based data service for functional insulin treatment of type 1 diabetes mellitus patients.

J Med Internet Res 2007 Dec 31;9(5):e36. Epub 2007 Dec 31.

Department of eHealth Systems, Austrian Research Centers GmbH - ARC, Graz, Austria.

Background: Patients with type 1 diabetes mellitus (DM1) have to be active participants in their treatment because they are inevitably responsible for their own day-to-day-care. Availability of mobile Internet access is advancing rapidly and mobile phones are now widely available at low cost. Thus, mobile phones have the potential to assist in daily diabetes management and to enable a telemedical interaction between patients and health care professionals.

Objective: The aim of the study was to evaluate the feasibility and user acceptance of a mobile phone-based data service to assist DM1 patients on intensive insulin treatment.

Methods: A software application called Diab-Memory (based on Java 2 Mobile Edition) has been developed to support patients when entering diabetes-related data with synchronization to the remote database at the monitoring center. The data were then processed to generate statistics and trends, which were provided for the patient and his/her health care professional via a Web portal. The system has been evaluated in the course of a clinical before-after pilot trial. Outcome measures focused on patients' adherence to the therapy, availability of the monitoring system, and the effects on metabolic status. General user acceptance of the system was evaluated using a questionnaire.

Results: Ten patients (four female) with DM1 participated in the trial. Mean age was 36.6 years (+/- 11.0 years) and prestudy glycated hemoglobin (HbA(1c)) was 7.9% (+/- 1.1%). A total of 3850 log-ins were registered during the 3 months of the study. The total number of received datasets was 13003, which equates to an average of 14 transmitted parameters per patient per day. The service was well accepted by the patients (no dropouts), and data transmission via mobile phone was successful on the first attempt in 96.5% of cases. Upon completion of the study, a statistically significant improvement in metabolic control was observed (HbA(1c): prestudy 7.9% +/- 1.1% versus poststudy 7.5% +/- 0.9%;P= .02). While there was a slight decrease in average blood glucose level (prestudy 141.8 mg/dL +/- 22.5 mg/dL vs poststudy 141.2 mg/dL +/- 23.1 mg/dL;P= .69), the difference was not statistically significant.

Conclusion: The results of the clinical pilot trial indicate that this proposed diabetes management system was well accepted by the patients and practical for daily usage. Thus, using the mobile phone as patient terminal seems to provide a ubiquitous, easy-to-use, and cost efficient solution for patient-centered data acquisition in the management of DM1. To confirm the promising results of the pilot trial further research has to be done to study long-term effects on glycemic control and cost-effectiveness.
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http://dx.doi.org/10.2196/jmir.9.5.e36DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2270419PMC
December 2007

Feasibility of a telemedicine framework for collaborative pacemaker follow-up.

J Telemed Telecare 2007 ;13(7):341-7

Austrian Research Centers GmbH, ARC, eHealth Systems, Graz, Austria.

We propose a telemedicine framework for remote and manufacturer independent pacemaker (PM) follow-up. The main goal is to provide the caregiver at the point-of-care with an efficient screening method to identify possible malfunction of the pacing system in collaboration with the specialist at the PM clinic. The concept was evaluated in a clinical trial on 44 patients (mean age 76 years). A total of 62 electrocardiogram (ECG) recordings were transmitted using a mobile PM follow-up unit. Using the automatic classification algorithm, 32 PMs were classified as 'OK' and eight PMs were classified as 'not OK'. In four cases a prediction regarding the working status of the PM was not possible. The signal processing classification was confirmed by expert classification (manual review of the ECG). The results indicate that the proposed PM follow-up concept has the potential to work as an efficient screening method and may spare a significant number of patients the burden of having to travel to specialized PM clinics.
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http://dx.doi.org/10.1258/135763307782215316DOI Listing
April 2008