Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study
Objectives To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Sta...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Elsevier
2021
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| _version_ | 1826272144929062912 |
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| author | 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 Cord, KM Sricharoenchai, S Busse, JW Agarwal, A Saccilotto, R Schwenkglenks, M Moffa, G Hemkens, LG Hopewell, S von Elm, E Blümle, A Briel, M |
| author_facet | 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 Cord, KM Sricharoenchai, S Busse, JW Agarwal, A Saccilotto, R Schwenkglenks, M Moffa, G Hemkens, LG Hopewell, S von Elm, E Blümle, A Briel, M |
| author_sort | Lohner, S |
| collection | OXFORD |
| description | Objectives
To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement.
Methods
We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions.
Results
Overall, 131 (24%) of trial protocols tested non-regulated interventions. In 2012, the median proportion of SPIRIT items reported in these protocols (59%, interquartile range [IQR], 53%-69%) was lower than in protocols with regulated interventions (median, 74%, IQR, 66%-80%). In 2016, the reporting quality of protocols with non-regulated interventions (median, 75%, IQR, 62%-83%) improved to the level of regulated intervention protocols, which had not changed on average.
Conclusions
Reporting of RCT protocols evaluating non-regulated interventions improved between 2012 and 2016, although remained suboptimal. SPIRIT recommendations need to be further endorsed by researchers, ethics committees, funding agencies, and journals to optimize reporting of RCT protocols.
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| first_indexed | 2024-03-06T22:07:54Z |
| format | Journal article |
| id | oxford-uuid:50c907c7-95ca-4f54-91e0-19c9383088c6 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:07:54Z |
| publishDate | 2021 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:50c907c7-95ca-4f54-91e0-19c9383088c62022-03-26T16:15:42ZReporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional studyJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:50c907c7-95ca-4f54-91e0-19c9383088c6EnglishSymplectic ElementsElsevier2021Lohner, SGryaznov, Dvon Niederhäusern, BSpeich, BKasenda, BOjeda-Ruiz, ESchandelmaier, SMertz, DOdutayo, ATomonaga, YAmstutz, APauli-Magnus, CGloy, VBischoff, KWollmann, KRehner, LMeerpohl, JJNordmann, AKlatte, KGhosh, NHeravi, ATWong, JChow, NHong, PJCord, KMSricharoenchai, SBusse, JWAgarwal, ASaccilotto, RSchwenkglenks, MMoffa, GHemkens, LGHopewell, Svon Elm, EBlümle, ABriel, MObjectives To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. Methods We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions. Results Overall, 131 (24%) of trial protocols tested non-regulated interventions. In 2012, the median proportion of SPIRIT items reported in these protocols (59%, interquartile range [IQR], 53%-69%) was lower than in protocols with regulated interventions (median, 74%, IQR, 66%-80%). In 2016, the reporting quality of protocols with non-regulated interventions (median, 75%, IQR, 62%-83%) improved to the level of regulated intervention protocols, which had not changed on average. Conclusions Reporting of RCT protocols evaluating non-regulated interventions improved between 2012 and 2016, although remained suboptimal. SPIRIT recommendations need to be further endorsed by researchers, ethics committees, funding agencies, and journals to optimize reporting of RCT protocols. |
| spellingShingle | 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 Cord, KM Sricharoenchai, S Busse, JW Agarwal, A Saccilotto, R Schwenkglenks, M Moffa, G Hemkens, LG Hopewell, S von Elm, E Blümle, A Briel, M Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study |
| title | Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study |
| title_full | Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study |
| title_fullStr | Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study |
| title_full_unstemmed | Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study |
| title_short | Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study |
| title_sort | reporting quality of trial protocols improved for non regulated interventions but not regulated interventions a repeated cross sectional study |
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