Commentary: On the levels of patient selection in registry-based randomized controlled trials
Abstract Registry-based randomized controlled trials (RCTs) are presumed to include a less-selected patient population and thus to have enhanced generalizability compared to conventional RCTs. However, this view disregards the levels of patient selection in registry-based RCTs: the registry selectio...
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| Format: | Article |
| Language: | English |
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BMC
2019-02-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3214-x |
| _version_ | 1818436294898876416 |
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| author | Florian Lasch Kristina Weber Armin Koch |
| author_facet | Florian Lasch Kristina Weber Armin Koch |
| author_sort | Florian Lasch |
| collection | DOAJ |
| description | Abstract Registry-based randomized controlled trials (RCTs) are presumed to include a less-selected patient population and thus to have enhanced generalizability compared to conventional RCTs. However, this view disregards the levels of patient selection in registry-based RCTs: the registry selection level and the trial selection level. At both levels, systematic selection can occur and generalizability can be diminished. Nevertheless, using a registry as a basis for recruitment, randomization, and data collection results in an advantage: the trial selection takes place within the registry framework, where baseline characteristics of non-enrolled patients are automatically documented as well. By comparing the baseline variables of the enrolled and non-enrolled patients, the trial selection can always be investigated, which gives a sound basis for discussing the generalizability to the registry population. |
| first_indexed | 2024-12-14T17:06:30Z |
| format | Article |
| id | doaj.art-c5a7b836b7454bf28b386a7c3ace7f9c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T17:06:30Z |
| publishDate | 2019-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c5a7b836b7454bf28b386a7c3ace7f9c2022-12-21T22:53:43ZengBMCTrials1745-62152019-02-012011610.1186/s13063-019-3214-xCommentary: On the levels of patient selection in registry-based randomized controlled trialsFlorian Lasch0Kristina Weber1Armin Koch2Department of Biostatistics, Hannover Medical SchoolDepartment of Biostatistics, Hannover Medical SchoolDepartment of Biostatistics, Hannover Medical SchoolAbstract Registry-based randomized controlled trials (RCTs) are presumed to include a less-selected patient population and thus to have enhanced generalizability compared to conventional RCTs. However, this view disregards the levels of patient selection in registry-based RCTs: the registry selection level and the trial selection level. At both levels, systematic selection can occur and generalizability can be diminished. Nevertheless, using a registry as a basis for recruitment, randomization, and data collection results in an advantage: the trial selection takes place within the registry framework, where baseline characteristics of non-enrolled patients are automatically documented as well. By comparing the baseline variables of the enrolled and non-enrolled patients, the trial selection can always be investigated, which gives a sound basis for discussing the generalizability to the registry population.http://link.springer.com/article/10.1186/s13063-019-3214-xRegistryRegistry-based RCTPatient selectionPragmatic trialsGeneralizabilityExternal validity |
| spellingShingle | Florian Lasch Kristina Weber Armin Koch Commentary: On the levels of patient selection in registry-based randomized controlled trials Trials Registry Registry-based RCT Patient selection Pragmatic trials Generalizability External validity |
| title | Commentary: On the levels of patient selection in registry-based randomized controlled trials |
| title_full | Commentary: On the levels of patient selection in registry-based randomized controlled trials |
| title_fullStr | Commentary: On the levels of patient selection in registry-based randomized controlled trials |
| title_full_unstemmed | Commentary: On the levels of patient selection in registry-based randomized controlled trials |
| title_short | Commentary: On the levels of patient selection in registry-based randomized controlled trials |
| title_sort | commentary on the levels of patient selection in registry based randomized controlled trials |
| topic | Registry Registry-based RCT Patient selection Pragmatic trials Generalizability External validity |
| url | http://link.springer.com/article/10.1186/s13063-019-3214-x |
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