Ten Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research: A Joint Journal and Pharmaceutical Industry Perspective

Mansi, Bernadette; Clark, Juli; David, Frank S.; Gesell, Thomas; Glasser, Susan; Gonzalez, John; Lainé, Christine; Miller, Charles L.; Mooney, LaVerne A.; Zecevic, Maja

doi:10.1016/j.mayocp.2012.02.009

Cited by 56 publications

(34 citation statements)

References 17 publications

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“…One point that contradicts with this assumption is the increasing morbidity and mortality rates of some interventional groups included in the literature review after the publication of the review paper (eg from 0% to 6.3%) (16). Although this appears to contradict with the concept of the learning curve, a detailed evaluation of the first manuscript by Murthy et al reveals that the majority of the reports included in the Pipeline series represent data from carefully controlled (pre-commercialization) device evaluation studies and/or vendor sponsored studies for regulatory approval of the device (such as PITA or PUFS studies) which may inherently contain bias (2,3,18,25) whereas those listed in the Silk report provide "real-life" results with lesser tendency for "cherry picking" of more suitable aneurysms. The inclusion of cases outside the context of trials may have result an increase in the morbidity and mortality rate.…”

Section: █ Conclusionmentioning

confidence: 99%

Silk device for the treatment of intracranial aneurysms, part 1: periprocedural results, technical aspects and learning curve

Gürkaş

Kaya²,

Dağlıoğlu³

et al. 2015

Turkish Neurosurgery

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Failure of these treatments led the physicians and the industry to investigate new techniques for better success rates to treat these large complex aneurysms. With the development of low-profile microcatheter-delivered self-expanding stents, intracranial parent artery reconstruction became feasible. Initially used technique was stent assisted coiling that resulted in better packing of the coils. With stenting, recurrence rates █ INTRODUCTION Endovascular aneurysm embolization with coils have been criticised for inability to achieve durable aneurysm exclusion when compared to surgical clipping. With coil embolization, this is valid especially for large and wide neck aneurysms that cannot be occluded completely during the procedure and at follow-up they usually show high rates of re-canalization (8,27). AIM:We evaluated the procedural outcomes of intracranial aneurysm treatment with the Silk device and its relation with operator experience. We also detailed some technical points we learned throughout our experience. MATERIAL and METHODS:One hundred and six consecutive patients with intracranial aneurysms treated using Silk (BaltExtrusion, Montmorency, France) stent between October 2010 and November 2013 were included. Patients were evaluated in terms of age, sex, aneurysm size, location, technical success, and adverse events. RESULTS:There were 106 patients (71 female) undergoing 116 procedures with a mean age of 49.8 (range: 3-78 years). Mean aneurysm size was 10.7±8.0 (range, 2-40 mm). Technical success of the procedures was 96.5%. Adverse event rate was 11.2%. Among adverse events, there were 4 adverse events without complications, 2 mild complications, 7 severe complications, 4 of which resulted with death. The adverse event rate was significantly higher during the first half of the operator's experience. The rate of adverse events seemed to stabilize after around 50 patients. Adverse events, regardless of the presence or absence of a clinical complication, were more frequent in aneurysms larger than 18.5 mm. CONCLUSION:Safety of flow-diverter (FD) placement for intracranial aneurysms increases with operator experience. Training programs in endovascular management of cerebrovascular diseases and relevant fellowship curricula must be adapted to include sufficient flow diverter experience. The learning curve needs to be kept in mind when studies comparing different FD devices or those comparing other treatments to FDS are planned.

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Section: █ Conclusionmentioning

confidence: 99%

Silk device for the treatment of intracranial aneurysms, part 1: periprocedural results, technical aspects and learning curve

Gürkaş

Kaya²,

Dağlıoğlu³

et al. 2015

Turkish Neurosurgery

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“…(1) Although GPP2 and the Medical Publishing Insights and Practices (MPIP) 6 Initiative are good initial efforts, how do we gain access to all individuals and organizations involved in the reporting of medical research? (2) How can ISMPP rebut inaccurate and outdated information related to medical publication?…”

Section: Topic 3: Advocacymentioning

confidence: 99%

Proceedings from the 9th Annual Meeting of International Society for Medical Publication Professionals Roundtable Session: key insights

Simcoe

Juneja

Scott

et al. 2013

Current Medical Research and Opinion

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“…Schott et al found mixed evidence on whether studies funded by industry or independent of industry were more likely to be published, but most of the evidence suggested that industry-funded trials had higher rates of publication. The need to report all results in a timely manner was one of the ten key recommendations recently made by editors and industry leaders to enhance the credibility of industry-sponsored research 10 . Arguably, this recommendation would hold for non-industry sponsored research as well.…”

Section: Low Publication Ratesmentioning

confidence: 99%

Poor compliance with reporting research results – we know it’s a problem … how do we fix it?

Woolley

Gertel²,

Hamilton

et al. 2012

Current Medical Research and Opinion

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Ten Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research: A Joint Journal and Pharmaceutical Industry Perspective

Cited by 56 publications

References 17 publications

Silk device for the treatment of intracranial aneurysms, part 1: periprocedural results, technical aspects and learning curve

Silk device for the treatment of intracranial aneurysms, part 1: periprocedural results, technical aspects and learning curve

Proceedings from the 9th Annual Meeting of International Society for Medical Publication Professionals Roundtable Session: key insights

Poor compliance with reporting research results – we know it’s a problem … how do we fix it?

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