Cross-sectional observational study of the availability of evidence supporting novel implantable devices used in gastrointestinal surgery

Chapman, Stephen J.; Shelton, B; Maruthappu, Mahiben; Singh, Pushpa; McCulloch, Peter; Bhangu, Aneel

doi:10.1002/bjs.10485

Cited by 3 publications

(5 citation statements)

References 23 publications

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“…Similar reviews have been performed in orthopaedics 37 and gastrointestinal surgery. 3 Findings were similar, although these studies did not look at the quality (in terms of risk of bias) of the RCTs, only whether there were any. The evidence in this study for vascular implantable devices adds to this body of literature and has the same obvious conclusions.…”

Section: Discussionmentioning

confidence: 94%

“…There are currently over 80 of these bodies. 3,4 The evaluation procedures and outcomes are protected by commercial confidentiality. Consequently, none disclose the evidence provided for the decision making process.…”

Section: Introductionmentioning

confidence: 99%

“…Consequently, none disclose the evidence provided for the decision making process. 3 While standards appear to be improving, 1,5 there is currently no legal requirement for any well defined evaluation process.…”

Section: Introductionmentioning

confidence: 99%

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Editor's Choice – Systematic Review and Narrative Synthesis of Randomised Controlled Trials Supporting Implantable Devices for Vascular and Endovascular Procedures

Wardle¹,

Botes²,

Ambler³

et al. 2022

European Journal of Vascular and Endovascular Surgery

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

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Editor's Choice – Systematic Review and Narrative Synthesis of Randomised Controlled Trials Supporting Implantable Devices for Vascular and Endovascular Procedures

Wardle¹,

Botes²,

Ambler³

et al. 2022

European Journal of Vascular and Endovascular Surgery

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“…Other issues identified included a poorly described clinical indication or target population [ 32 ]; the use of predicate devices [ 24 , 26 ]; small sample sizes [ 30 , 31 ]; no patient-relevant study outcomes [ 10 , 17 , 28 ]; or the sole use of surrogate outcomes [ 28 ]; and limited long-term data [ 26 ]. No evidence was found for some devices [ 33 , 34 , 29 ], whilst some authors found that the evidence for some devices showed them to be no better or less safe/effective than other treatments [ 27 ].…”

Section: Resultsmentioning

confidence: 99%

“…Sauerland et al (2014) warn that all the steps in the IDEAL framework need to be taken [ 18 ], including conducting RCTs to determine efficacy: “The pitfall to be avoided is acceptance of preliminary non-randomized data as proof of the new devices or procedure’s superiority.” This stepwise approach to introducing high-risk devices whilst gathering additional robust RCT data on their effectiveness and longer-term safety profile is another potential way of preventing the widespread adoption of unproven treatments. However, this requires the support of the regulatory system [ 29 ] to limit the risk of harm [ 56 , 57 ]. Additional legislation may be required to allow only limited market access until this data is available and to require special reporting of all clinical outcomes post-CE marking.…”

Section: Discussionmentioning

confidence: 99%

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

Hulstaert¹,

Pouppez²,

Jong³

et al. 2023

Orphanet J Rare Dis

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Aim To determine the level of evidence for innovative high-risk medical devices at market entry. Methods We reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb-III) available between 2018 to mid-2019 on applications submitted for inclusion on their reimbursement list. We also conducted a review of the literature on evidence gaps and an analysis of relevant legal and ethical frameworks within the European context. Findings Conformity assessment of medical devices is based on performance, safety, and an acceptable risk-benefit balance. Information submitted for obtaining CE marking is confidential and legally protected, limiting access to clinical evidence. Seven out of the 18 RIZIV-INAMI assessor reports (39%) included a randomized controlled trial (RCT) using the novel device, whilst 2 applications (11%) referred to an RCT that used a different device. The population included was inappropriate or unclear for 3 devices (17%). Only half of the applications presented evidence on quality of life or functioning and 2 (11%) presented overall survival data. Four applications (22%) included no data beyond twelve months. The findings from the literature demonstrated similar problems with the study design and the clinical evidence. Discussion and conclusions CE marking does not indicate that a device is effective, only that it complies with the law. The lack of transparency hampers evidence-based decision making. Despite greater emphasis on clinical benefit for the patient, the provisions of the European Medical Device Regulation (MDR) are not yet fully aligned with international ethical standards for clinical research. The MDR fails to address key issues, such as the lack of access to data submitted for CE marking and a failure to require evidence of clinical effectiveness. Indeed, a first report shows no improvement in the clinical evidence for implantable devices generated under the MDR. Thus, patients may continue to be exposed to ineffective or unsafe novel devices. The Health Technology Assessment Regulation plans for Joint Scientific Consultations for specific high-risk devices before companies begin their pivotal clinical investigations. The demanded comparative evidence should facilitate payer decisions. Nevertheless, there is also a need for legislation requiring comparative RCTs assessing patient-relevant outcomes for high-risk devices to ensure implementation, including development and implementation of common specifications for study designs.

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Recommendations for Randomised Trials in Surgical Oncology

et al. 2017

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Trials of surgical procedures in the treatment of malignant disease face a unique set of challenges. This review aimed to describe recommendations for the design, delivery and reporting of randomised trials in surgical oncology. A literature search was carried out without date limits to identify articles related to trial methodology research in surgery and surgical oncology. A narrative review was framed around two open National Institute of Health Research portfolio trials in colon and rectal cancer: the STAR-TREC trial (ISRCTN14240288) and the ROCCS trial (ISRCTN46330337). Twelve specific challenges were highlighted: standardisation of technique; pilot and feasibility studies; balancing treatments; the recruitment pathway; outcome measures; patient and public representation; trainee-led networks; randomisation; novel techniques and training; learning curves; blinding; follow-up. Evidence-based recommendations were made for the future design and conduct of surgical oncology trials. Better understanding of the challenges facing trials in the surgical treatment of cancer will accelerate high-quality evaluation and rapid adoption of innovation for the benefit of patient care.

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Cross-sectional observational study of the availability of evidence supporting novel implantable devices used in gastrointestinal surgery

Abstract: Only one in ten novel implantable devices available for use in gastrointestinal surgical practice is supported by high-quality RCT evidence.

Cited by 3 publications

References 23 publications

Editor's Choice – Systematic Review and Narrative Synthesis of Randomised Controlled Trials Supporting Implantable Devices for Vascular and Endovascular Procedures

Editor's Choice – Systematic Review and Narrative Synthesis of Randomised Controlled Trials Supporting Implantable Devices for Vascular and Endovascular Procedures

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

Recommendations for Randomised Trials in Surgical Oncology

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