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4. Medical device regulation efforts for mHealth apps -- An experience report of Corona Check and Corona Health

Author

Holfelder, Marc, Mulansky, Lena, Schlee, Winfried, Baumeister, Harald, Schobel, Johannes, Greger, Helmut, Hoff, Andreas, and Pryss, Rüdiger

Subjects
Computer Science - Software Engineering, Computer Science - Computers and Society
Abstract

Within the healthcare environment, mobile health (mHealth) applications (apps) are more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the Covid-19 pandemic has led to an enormous amount of app releases. Notably, in most countries, mHealth applications have to be already compliant with several regulatory aspects in order to be declared to be a 'medical app'. However, the latest applicable medical device regulation (MDR) does not comment in more detail on the topic of the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team - especially the software engineers - are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled too long due to the integration of the MDR. Therefore, a developing framework, which includes these aspects, is required, to enable a smooth development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized to a guidance for medical app developments. In particular, the important stages and faced challenges emerged during the entire development process are highlighted.

Published
2021

29. Abstracts from the 3rd Conference on Aneuploidy and Cancer: Clinical and Experimental Aspects

Author

Cornish-Bowden, Athel, Rasnick, David, Heng, Henry H, Horne, Steven, Abdallah, Batoul, Liu, Guo, Ye, Christine J, Bloomfield, Mathew, Vincent, Mark D, Aldaz, C Marcelo, Karlsson, Jenny, Valind, Anders, Jansson, Caroline, Gisselsson, David, Graves, Jennifer A Marshall, Stepanenko, Aleksei A, Andreieva, Svitlana V, Korets, Kateryna V, Mykytenko, Dmytro O, Huleyuk, Nataliya L, Baklaushev, Vladimir P, Kovaleva, Oksana A, Chekhonin, Vladimir P, Vassetzky, Yegor S, Avdieiev, Stanislav S, Bakker, Bjorn, Taudt, Aaron S, Belderbos, Mirjam E, Porubsky, David, Spierings, Diana CJ, de Jong, Tristan V, Halsema, Nancy, Kazemier, Hinke G, Hoekstra-Wakker, Karina, Bradley, Allan, de Bont, Eveline SJM, van den Berg, Anke, Guryev, Victor, Lansdorp, Peter M, Tatché, Maria Colomé, Foijer, Floris, Liehr, Thomas, Baudoin, Nicolaas C, Nicholson, Joshua M, Soto, Kimberly, Quintanilla, Isabel, Camps, Jordi, Cimini, Daniela, Dürrbaum, M, Donnelly, N, Passerini, V, Kruse, C, Habermann, B, Storchová, Z, Mandrioli, Daniele, Belpoggi, Fiorella, Silbergeld, Ellen K, Perry, Melissa J, Skotheim, Rolf I, Løvf, Marthe, Johannessen, Bjarne, Hoff, Andreas M, Zhao, Sen, SveeStrømme, Jonas M, Sveen, Anita, Lothe, Ragnhild A, Hehlmann, R, Voskanyan, A, Fabarius, A, Böcking, Alfred, Biesterfeld, Stefan, Berynskyy, Leonid, Börgermann, Christof, Engers, Rainer, Dietz, Josef, Fritz, A, Sehgal, N, Vecerova, J, Stojkovicz, B, Ding, H, Page, N, Tye, C, Bhattacharya, S, Xu, J, Stein, G, Stein, J, Berezney, R, Gong, Xue, Grasedieck, Sarah, Swoboda, Julian, Rücker, Frank G, Bullinger, Lars, Pollack, Jonathan R, Roumelioti, Fani-Marlen, Chiourea, Maria, Raftopoulou, Christina, Gagos, Sarantis, Duesberg, Peter, and Bloomfield, Mat

Subjects
Genetics
Published
2017

35. The Danish Ibbis Trials for Sickness Absentees with Common Mental Disorders: A Phase 4 Prospective Study Comparing Randomized Trial and Real-World Data.

Author

Hoff, Andreas, Bojesen, Anders Bo, and Falgaard Eplov, Lene

Subjects
*POISSON distribution, *RANDOM forest algorithms, *JOB absenteeism, *T-test (Statistics), *RESEARCH funding, *REHABILITATION of people with mental illness, *INTERVIEWING, *QUESTIONNAIRES, *LOGISTIC regression analysis, *EVALUATION of medical care, *ANXIETY, *TREATMENT effectiveness, *DESCRIPTIVE statistics, *LONGITUDINAL method, *VOCATIONAL rehabilitation, *RESEARCH methodology, *ELIGIBILITY (Social aspects), *PSYCHOLOGICAL tests, *CONFIDENCE intervals, *MENTAL depression, *REGRESSION analysis, *NONPARAMETRIC statistics
Abstract

Introduction: In two randomized controlled trials (RCT) we tested the efficacy of a novel integrated vocational rehabilitation and mental healthcare intervention, coined INT, for sickness absentees with common mental disorders. The aim was to improve vocational outcomes compared to Service As Usual (SAU). Contrary to expectations, the delivered intervention caused worse outcomes within some diagnostic groups and some benefits in others. In this phase 4 study, we examined the effectiveness of the intervention in real-world practice. Method: In this prospective intervention study, we allocated adult sickness absentees with either depression, anxiety, or adjustment disorder to receive INT in a real-world setting in a Danish Municipality. We compared the vocational outcomes of this group to a matched group who received INT as a part of the RCTs, after randomization to the intervention group herein. Primary outcome was return to work at any point within 12 months. Results: In the real-world group, 151 participants received INT during 2019. From the randomized trials, 302 matched participants who received INT between 2016–2018 were included. On the primary outcome – return to work within 12 months – the real-word group fared worse (48.3 vs 64.6 %, OR 0.54 [95%CI: 0.37–0.79], p = 0.001). Across most other vocational outcomes, a similar pattern of statistically significant poorer outcomes in the real-world group was observed: Lower number of weeks in work and lower proportion in work at 12 months (42.3% vs. 58.3% (p = 0.002)). Discussion: The real-word group showed significantly worse vocational outcomes. Like in many other studies of complex interventions, implementation was difficult in the original randomized trials and perhaps even more difficult in the less structured real-world setting. Since the intervention was less effective for some groups compared to SAU in the original trial, this negative effect may be even more pronounced in a real-world setting. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Structural Alterations Driving Castration-Resistant Prostate Cancer Revealed by Linked-Read Genome Sequencing

Author

Viswanathan, Srinivas R., Ha, Gavin, Hoff, Andreas M., Wala, Jeremiah A., Carrot-Zhang, Jian, Whelan, Christopher W., Haradhvala, Nicholas J., Freeman, Samuel S., Reed, Sarah C., Rhoades, Justin, Polak, Paz, Cipicchio, Michelle, Wankowicz, Stephanie A., Wong, Alicia, Kamath, Tushar, Zhang, Zhenwei, Gydush, Gregory J., Rotem, Denisse, Love, J. Christopher, Getz, Gad, Gabriel, Stacey, Zhang, Cheng-Zhong, Dehm, Scott M., Nelson, Peter S., Van Allen, Eliezer M., Choudhury, Atish D., Adalsteinsson, Viktor A., Beroukhim, Rameen, Taplin, Mary-Ellen, and Meyerson, Matthew

Published
2018
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49. Integrated mental healthcare and vocational rehabilitation for people on sick leave with stress-related disorders: 24-month follow-up of the randomized IBBIS trial

Author

Hoff, Andreas, Poulsen, Rie Mandrup, Fisker, Jonas Peter, Hjorthøj, Carsten, Nordentoft, Merete, Bojesen, Anders Bo, and Eplov, Lene Falgaard

Subjects
common mental disorder, adjustment disorder, return-to-work, exhaustion disorder, randomized trial, Public Health, Environmental and Occupational Health, distress, integrated service, return to work, stepped care
Abstract

Objectives Integrating vocational rehabilitation and mental healthcare has shown effects on vocational outcomes during sick leave with common mental disorders. In a previous paper, we showed that a Danish integrated healthcare and vocational rehabilitation intervention (INT) had a surprisingly negative impact on vocational outcomes compared to service as usual (SAU) at 6- and 12-month follow-up. That was also the case with a mental healthcare intervention (MHC) tested in the same study. This article reports the 24-month follow-up results of that same study.Method A randomized, parallel-group, three-arm, multi-centre superiority trial was conducted to test the effectiveness of INT and MHC compared to SAU.Results In total, 631 persons were randomized. Contrary to our hypothesis, SAU showed faster return to work than both INT [hazard rate (HR) 1.39, P=0.0027] and MHC (HR 1.30, P=0.013) at 24-month follow-up. Overall, no differences were observed regarding mental health and functional level. Compared to SAU, we observed some health benefits of MHC, but not INT, at 6-month follow-up but not thereafter, and lower rates of employment at all follow-ups. Since implementation problems might explain the results of INT, we cannot conclude that INT is no better that SAU. The MHC intervention was implemented with good fidelity and did not improve return to work.Conclusion This trial does not support the hypothesis that INT lead to faster return to work. However, implementation failure may explain the negative results. Objectives Integrating vocational rehabilitation and mental healthcare has shown effects on vocational outcomes during sick leave with common mental disorders. In a previous paper, we showed that a Danish integrated healthcare and vocational rehabilitation intervention (INT) had a surprisingly negative impact on vocational outcomes compared to service as usual (SAU) at 6-and 12-month follow-up. That was also the case with a mental healthcare intervention (MHC) tested in the same study. This article reports the 24-month follow-up results of that same study. Method A randomized, parallel-group, three-arm, multi-centre superiority trial was conducted to test the effectiveness of INT and MHC compared to SAU. Results In total, 631 persons were randomized. Contrary to our hypothesis, SAU showed faster return to work than both INT [hazard rate (HR) 1.39, P=0.0027] and MHC (HR 1.30, P=0.013) at 24-month follow-up. Overall, no differences were observed regarding mental health and functional level. Compared to SAU, we observed some health benefits of MHC, but not INT, at 6-month follow-up but not thereafter, and lower rates of employment at all follow-ups. Since implementation problems might explain the results of INT, we cannot conclude that INT is no better that SAU. The MHC intervention was implemented with good fidelity and did not improve return to work. Conclusion This trial does not support the hypothesis that INT lead to faster return to work. However, implementation failure may explain the negative results.

Published
2023
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