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Feedback of results to trial participants: be upfront or risk affront

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www.thelancet.com Vol 389 March 25, 2017 1191 1 Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study. Lancet 2011; 378: 1997–2004.… Click to show full abstract

www.thelancet.com Vol 389 March 25, 2017 1191 1 Jungebluth P, Alici E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study. Lancet 2011; 378: 1997–2004. 2 Backman S, Björling G, Johansson U–B, et al. Material wear of polymeric tracheostomy tubes—a six-month study. Laryngoscope 2009; 119: 657–664. 3 Björling G, Johansson U–B, Andersson G, et al. A retrospective survey of outpatients with long-term tracheostomy. Acta Anaesthesiol Scand 2006; 50: 399–406. its excellent biocompatibility, in-vivo biostability, and superior mechanical properties. However, important facts are disregarded in the Article, especially regarding the long-term effect of an unsterile environment, such as the trachea, on implant material. In 2009, our interdisciplinary research group published a study on the effect that the tracheal environment had on various tracheostomy tube materials after months of exposure. Medical grade silicone, polyvinyl chloride (PVC), and PCU were evaluated, with material degradation evident in all tubes. Jungebluth and colleagues continued using their implants in younger patients with a benign indication for tracheostomy. From an ethical point of view, this is even more troublesome, since outpatients with chronic tracheostomy have unaffected life expectancy. However, the research group moved on towards disaster as their institutions and uncritical reviewers, appearing to sense a scientific breakthrough, cheered them on. The mechanisms at play are now being exposed, resulting in multiple administrative corrective actions. In addition to this, editors of prestigious journals also need to contemplate how to interact more carefully with deviating academic cultures.

Keywords: trial participants; results trial; upfront risk; participants upfront; tracheostomy; feedback results

Journal Title: The Lancet
Year Published: 2017

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