ASPIRE:Adherence to SPIrit Recommendations

DISCO: Study of DISCOntinued Trials

Randomized clinical trials (RCTs) are the method of choice to evaluate therapeutic and prophylactic interventions in health care. Protocols are crucial in the planning and conduct of new RCTs, because they provide a detailed description of the rationale, research question(s), methodology, processes, planned analyses and results dissemination for a new trial. To improve the reporting of trial protocols, the SPIRIT checklist with a minimum set of items to be reported in a protocol was published in 2013. In the Adherence to SPIRIT Recommendations (ASPIRE) project we aimed to assess the comprehensiveness/reporting of RCT protocols in a repeated cross-sectional study to investigate the reporting quality of RCT protocols longitudinally. For this we included a random sample of RCT protocols approved by research ethics committees in Switzerland, Germany, Canada, and the United Kingdom in 2012 and in 2016.  We used the RCT protocols included in ASPIRE in addition to check the proportion of prospectively registered RCTs, prematurely discontinued RCTs (with reasons for discontinuation), RCTs with publicly available results, and RCTs with publicly available protocol (DISCO studies).

In further meta-research studies we are investigating the planning of subgroup analyses, the planning and reporting of patient-reported outcomes, and the use of routinely collected data in RCTs of the ASPIRE sample.  In an other project, we investigate how often and through which sources RCT protocols are made available, using the trial sample from the ASPIRE project.

Study protocols:

Gryaznov D, Odutayo A, von Niederhäusern B, et al. Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects. Trials. 2020;21(1):896. Published 2020 Oct 28. doi:10.1186/s13063-020-04808-y

Results publications:

Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study.  Lohner S, Gryaznov D, von Niederhäusern B, Speich B, Kasenda B, Ojeda-Ruiz E, Schandelmaier S, Mertz D, Odutayo A, Tomonaga Y, Amstutz A, Pauli-Magnus C, Gloy V, Bischoff K, Wollmann K, Rehner L, Meerpohl JJ, Nordmann A, Klatte K, Ghosh N, Heravi AT, Wong J, Chow N, Hong PJ, McCord K, Sricharoenchai S, Busse JW, Agarwal A, Saccilotto R, Schwenkglenks M, Moffa G, Hemkens LG, Hopewell S, von Elm E, Blümle A, Briel M. J Clin Epidemiol. 2021 Nov;139:340-349. doi: 10.1016/j.jclinepi.2021.05.011. Epub 2021 Ma

Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials. Taji Heravi A, Gryaznov D, Schandelmaier S, Kasenda B, Briel M; Adherence to SPIRIT Recommendations (ASPIRE) Study Group .JAMA Netw Open. 2021 Oct 1;4(10):e2131503. doi: 10.1001/jamanetworkopen.2021.31503.

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.  Speich B, Gryaznov D, Busse JW, Gloy VL, Lohner S, Klatte K, Taji Heravi A, Ghosh N, Lee H, Mansouri A, Marian IR, Saccilotto R, Nury E, Kasenda B, Ojeda-Ruiz E, Schandelmaier S, Tomonaga Y, Amstutz A, Pauli-Magnus C, Bischoff K, Wollmann K, Rehner L, Meerpohl JJ, Nordmann A, Wong J, Chow N, Hong PJ, Mc Cord-De Iaco K, Sricharoenchai S, Agarwal A, Schwenkglenks M, Hemkens LG, von Elm E, Copsey B, Griessbach AN, Schönenberger C, Mertz D, Blümle A, von Niederhäusern B, Hopewell S, Odutayo A, Briel M. PLoS Med. 2022 Apr 27;19(4):e1003980. doi: 10.1371/journal.pmed.1003980. eCollection 2022 Apr

Reliability of Trial Information Across Registries for Trials With Multiple Registrations: A Systematic Review.  Speich B, Gloy VL, Klatte K, Gryaznov D, Taji Heravi A, Ghosh N, Marian IR, Lee H, Mansouri A, Lohner S, Saccilotto R, Nury E, Chan AW, Blümle A, Odutayo A, Hopewell S, Briel M; Adherence to Spirit Recommendations (ASPIRE) Study Group.  JAMA Netw Open. 2021 Nov 1;4(11):e2128898. doi: 10.1001/jamanetworkopen

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).  Gryaznov D, von Niederhäusern B, Speich B, Kasenda B, Ojeda-Ruiz E, Blümle A, Schandelmaier S, Mertz D, Odutayo A, Tomonaga Y, Amstutz A, Pauli-Magnus C, Gloy V, Lohner S, Bischoff K, Wollmann K, Rehner L, Meerpohl JJ, Nordmann A, Klatte K, Ghosh N, Taji Heravi A, Wong J, Chow N, Hong P, McCord-De Iaco KA, Sricharoenchai S, Busse JW, Agarwal A, Saccilotto R, Schwenkglenks M, Moffa G, Hemkens L, Hopewell S, Von Elm E, Briel M. BMJ Open. 2022 May 24;12(5):e053417. doi: 10.1136/bmjopen-2021-053417

A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols.  Schönenberger CM, Griessbach A, Taji Heravi A, Gryaznov D, Gloy VL, Lohner S, Klatte K, Ghosh N, Lee H, Mansouri A, Marian IR, Saccilotto R, Nury E, Busse JW, von Niederhäusern B, Mertz D, Blümle A, Odutayo A, Hopewell S, Speich B, Briel M. J Clin Epidemiol. 2022 Sep;149:45-52. doi: 10.1016/j.jclinepi.2022.05.014

A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study.  Speich B, Odutayo A, Peckham N, Ooms A, Stokes JR, Saccilotto R, Gryaznov D, von Niederhäusern B, Copsey B, Altman DG, Briel M, Hopewell S. Trials. 2022 Jul 27;23(1):601.doi:10.1186/s13063-022-06516-1

Contact person:

Matthias Briel