Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review

Motte, Anne-France; Diallo, Stéphanie; Brink, Hélène van den; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, P; Cour, F.; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas

doi:10.1016/j.jclinepi.2017.07.005

Cited by 5 publications

(5 citation statements)

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“…This method has been reported to be useful in monitoring a learning curve with regard to the incidence of perioperative complications. Therefore, studies dealing with TAVI procedures should ideally evoke a protocol in which a learning curve would have been anticipated, but we found that in many studies this was not the case (9).…”

Section: Discussionmentioning

confidence: 97%

“…These many allusions to the learning curve remain very heterogeneous in terms of details. As shown by Motte et al (9), this is probably due to the fact that no guidelines exist for reporting clinical trials on implantable medical devices. However, this same article has determined some relevant items for reporting clinical trials on implantable medical devices, and the learning curve was identified as one of them.…”

Section: Discussionmentioning

confidence: 99%

“…In a trial report on TAVI, it clearly appears important to know how the training of the operators was managed. Indeed, it may be difficult to establish the external validity of the study, also called generalizability, without this information (9). In addition, if the roll-in phase is not conducted adequately, an insufficient training regime may lead to an increase in adverse events that are caused by operator error (14).…”

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confidence: 99%

“…Indeed, several studies have suggested that TAVI procedures are technically complex and have a significant learning curve (5)(6)(7)(8). In a trial report on a medical device by Motte et al, it appears essential to know how the learning curve was evaluated or how the training of operators was managed (9). A minimum amount of training for each operator is required to complete this learning curve, as well as carrying out a minimum number of procedures per year to maintain TAVI competency.…”

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confidence: 99%

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The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Thivilliers

Ladarré

Merabti

et al. 2020

Int J Technol Assess Health Care

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BackgroundTranscatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.Materials and methodsA systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.ResultsA total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.ConclusionMany prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Thivilliers

Ladarré

Merabti

et al. 2020

Int J Technol Assess Health Care

Self Cite

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“…Many principles of trial design used for pharmaceutical products apply also for medical devices, but some characteristics of high-risk devices imply a need for different guidance. 19 Incremental development with short life-cycles, the physical mode of action, the complexity of interventions, and dependency on contextual factors may lead to device modifications during the course of clinical investigations, hinder blinding, or imbalance recruitment to study arms due to provider and patient preferences. Individual and institutional learning curves may have to be taken into account when quantifying the effect of an intervention.…”

Section: Methods Used To Generate Clinical Evidence For High-risk Medical Devicesmentioning

confidence: 99%

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

et al. 2021

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In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details – which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE–MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081

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Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices

Chen

Zhang

et al. 2019

Surgery

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Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review

Cited by 5 publications

References 41 publications

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices

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