Document is current

Article History

Received: 3 April 2019

Accepted: 7 September 2019

First Online: 9 December 2019

Ethics approval and consent to participate

: Ethics approval is not applicable for this manuscript, as it describes methodological development work and uses simulated data only.

: Not applicable.

: All authors have previously received or are currently in receipt of funding from the NIHR. MU was Chair of the NICE accreditation advisory committee until March 2017 for which he received a fee. MU is also chief investigator or co-investigator on multiple previous and current research grants from the NIHR and Arthritis Research UK, and he is a co-investigator on grants funded by the Australian National Health and Medical Research Council (NHMRC) and an NIHR Senior Investigator. MU has received travel expenses for speaking at conferences from the professional organisations hosting the conferences, and he is a director and shareholder of Clinvivo Ltd, which provides electronic data collection for health services research. MU is part of an academic partnership with Serco Ltd related to return to work initiatives, an editor of the NIHR journal series and a member of the NIHR Journal Editors Group, for which he receives a fee. The makers of the InSpace balloon, Orthospace Ltd, have had no involvement in the conception, design, conduct or analysis of this work, and have had no involvement in preparing the manuscript except to check its content for intellectual property transgressions. They are providing 50 free balloons for the trial and have provided training for surgeons in using the device, but they have no other involvement in the trial. The full independence of the trial team is clearly laid out contractually in line with standard NIHR terms.