A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study
<p><strong>Background</strong><br> To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.<br><br>...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
BioMed Central
2022
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| _version_ | 1826309595478360064 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Speich, B |
| collection | OXFORD |
| description | <p><strong>Background</strong><br>
To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.<br><br>
<strong>Methods</strong><br>
We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor.<br><br>
<strong>Results</strong><br>
The proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6–69.2%) in 2012 to a median of 72.5% (IQR, 65.3–78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR, 64.1–69.4%) compared to non-industry-sponsored trials (median 59.8%; IQR, 46.5–67.7%). This gap between industry- and non-industry-sponsored trials increased in 2016 (industry-sponsored: median 75.6%; IQR, 71.2–79.0% vs non-industry-sponsored: median 65.3%; IQR, 51.6–76.3%).<br><br>
<strong>Conclusions</strong><br>
The adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs.</p> |
| first_indexed | 2024-03-07T07:38:06Z |
| format | Journal article |
| id | oxford-uuid:81258b7b-b380-4f68-9eda-9a1cca974284 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:38:06Z |
| publishDate | 2022 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:81258b7b-b380-4f68-9eda-9a1cca9742842023-03-21T11:56:52ZA longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) studyJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:81258b7b-b380-4f68-9eda-9a1cca974284EnglishSymplectic ElementsBioMed Central2022Speich, BOdutayo, APeckham, NOoms, AStokes, JRSaccilotto, RGryaznov, Dvon Niederhäusern, BCopsey, BAltman, DGBriel, MHopewell, S<p><strong>Background</strong><br> To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.<br><br> <strong>Methods</strong><br> We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor.<br><br> <strong>Results</strong><br> The proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6–69.2%) in 2012 to a median of 72.5% (IQR, 65.3–78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR, 64.1–69.4%) compared to non-industry-sponsored trials (median 59.8%; IQR, 46.5–67.7%). This gap between industry- and non-industry-sponsored trials increased in 2016 (industry-sponsored: median 75.6%; IQR, 71.2–79.0% vs non-industry-sponsored: median 65.3%; IQR, 51.6–76.3%).<br><br> <strong>Conclusions</strong><br> The adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs.</p> |
| spellingShingle | 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 A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study |
| title | A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study |
| title_full | A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study |
| title_fullStr | A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study |
| title_full_unstemmed | A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study |
| title_short | A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study |
| title_sort | longitudinal assessment of trial protocols approved by research ethics committees the adherance to spirit recommendations in the uk aspire uk study |
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