The new European regulatory framework for medical devices: opportunities for engagement by electrophysiologists†

Szymański, Piotr; Leggeri, Ilaria; Kautzner, Josef; Fraser, Alan G.

doi:10.1093/europace/eux344

Cited by 3 publications

(2 citation statements)

References 6 publications

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“…Value-based healthcare has emerged in recent years as the primary focus for authorities, decision-makers and the public (1)(2)(3). Medical interventions are evaluated on the basis of their safety, e cacy and costeffectiveness (4)(5)(6). Whilst randomized controlled trials (RCT) are the gold standard method for such an evaluation, the post-marketing surveillance of clinical outcomes using real-world data is increasingly demanded by regulators and the public (1,(4)(5)(6).…”

Section: Introductionmentioning

confidence: 99%

“…Medical interventions are evaluated on the basis of their safety, e cacy and costeffectiveness (4)(5)(6). Whilst randomized controlled trials (RCT) are the gold standard method for such an evaluation, the post-marketing surveillance of clinical outcomes using real-world data is increasingly demanded by regulators and the public (1,(4)(5)(6). However, there is a need to standardize the methods by which these outcomes are de ned and captured.…”

Section: Introductionmentioning

confidence: 99%

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Novel approach to extract candidate outcomes from literature for a standard outcome set: A case- and simulation study

Veen

Joseph²,

Sossi³

et al. 2023

Preprint

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Aims Standard outcome sets enable the value-based evaluation of health care delivery. Whereas the attainment of expert opinion has been structured using methods such as the modified-Delphi process, standardized guidelines for extraction of candidate outcome measures from literature are lacking. As such, we aimed to describe a novel methodology to obtain a comprehensive list of candidate outcome measures for potential inclusion in standard outcome datasets. Methods We designed a three-key steps to develop a list of candidate outcome measures to evaluate healthcare and applied these steps for the development of the international consortium of health outcome measures Heart valve disease dataset to illustrate the method. Our methodological approach involves: 1) Benchmark review of relevant registries and Clinical Practice Guidelines; 2) Applying machine learning to screen (using frequent words in abstracts) the studies that have been extracted from a systematic search of the literature using only the disease term; and 3) Extracting the candidate outcome measures from randomly selected batches of the retrieved studies iteratively until saturation is reached. Batch cutoff choices were investigated using data of 1000 simulated cases. Results Simulation showed that on average 98% (range 92% to 100%) saturation is reached using a 100-article batch initially, with 25 articles in the subsequent batches. On average 1.7 repeating rounds (range 1-5) of 25 new articles were necessary to achieve saturation. Conclusion In this paper a standardized three-pillar approach is proposed to identify relevant outcome measures for a standard dataset. This approach creates a balance between comprehensiveness and feasibility in conducting literature reviews for the identification of candidate outcome measures.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Novel approach to extract candidate outcomes from literature for a standard outcome set: A case- and simulation study

Veen

Joseph²,

Sossi³

et al. 2023

Preprint

View full text Add to dashboard Cite

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The digital journey: 25 years of digital development in electrophysiology from an Europace perspective

Svennberg,

Caiani,

Bruining

et al. 2023

Europace

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Aims Over the past 25 years there has been a substantial development in the field of digital electrophysiology (EP) and in parallel a substantial increase in publications on digital cardiology. In this celebratory paper, we provide an overview of the digital field by highlighting publications from the field focusing on the EP Europace journal. Results In this journey across the past quarter of a century we follow the development of digital tools commonly used in the clinic spanning from the initiation of digital clinics through the early days of telemonitoring, to wearables, mobile applications, and the use of fully virtual clinics. We then provide a chronicle of the field of artificial intelligence, a regulatory perspective, and at the end of our journey provide a future outlook for digital EP. Conclusion Over the past 25 years Europace has published a substantial number of papers on digital EP, with a marked expansion in digital publications in recent years.

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Standardized approach to extract candidate outcomes from literature for a standard outcome set: a case- and simulation study

Veen,

Joseph,

Sossi

et al. 2023

BMC Med Res Methodol

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Aims Standard outcome sets enable the value-based evaluation of health care delivery. Whereas the attainment of expert opinion has been structured using methods such as the modified-Delphi process, standardized guidelines for extraction of candidate outcomes from literature are lacking. As such, we aimed to describe an approach to obtain a comprehensive list of candidate outcomes for potential inclusion in standard outcome sets. Methods This study describes an iterative saturation approach, using randomly selected batches from a systematic literature search to develop a long list of candidate outcomes to evaluate healthcare. This approach can be preceded with an optional benchmark review of relevant registries and Clinical Practice Guidelines and data visualization techniques (e.g. as a WordCloud) to potentially decrease the number of iterations. The development of the International Consortium of Health Outcome Measures Heart valve disease set is used to illustrate the approach. Batch cutoff choices of the iterative saturation approach were validated using data of 1000 simulated cases. Results Simulation showed that on average 98% (range 92–100%) saturation is reached using a 100-article batch initially, with 25 articles in the subsequent batches. On average 4.7 repeating rounds (range 1–9) of 25 new articles were necessary to achieve saturation if no outcomes are first identified from a benchmark review or a data visualization. Conclusion In this paper a standardized approach is proposed to identify relevant candidate outcomes for a standard outcome set. This approach creates a balance between comprehensiveness and feasibility in conducting literature reviews for the identification of candidate outcomes.

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The new European regulatory framework for medical devices: opportunities for engagement by electrophysiologists†

Cited by 3 publications

References 6 publications

Novel approach to extract candidate outcomes from literature for a standard outcome set: A case- and simulation study

Novel approach to extract candidate outcomes from literature for a standard outcome set: A case- and simulation study

The digital journey: 25 years of digital development in electrophysiology from an Europace perspective

Standardized approach to extract candidate outcomes from literature for a standard outcome set: a case- and simulation study

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