Improved adherence adjustment in the Coronary Drug Project
Abstract Background The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted....
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| Format: | Article |
| Language: | English |
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BMC
2018-03-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2519-5 |
| _version_ | 1811269833409429504 |
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| author | Eleanor J. Murray Miguel A. Hernán |
| author_facet | Eleanor J. Murray Miguel A. Hernán |
| author_sort | Eleanor J. Murray |
| collection | DOAJ |
| description | Abstract Background The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full advantage of recent methodological developments. Methods We used inverse-probability weighted hazards models to estimate the 5-year survival and mortality risk when individuals in the placebo arm of the Coronary Drug Project adhere to at least 80% of the drug continuously or never during the 5-year follow-up period. Results Adjustment for post-randomization covariates resulted in 5-year mortality risk difference estimates ranging from − 0.7 (95% confidence intervals (CI), − 12.2, 10.7) to 4.5 (95% CI, − 6.3, 15.3) percentage points. Conclusions Our analysis confirms that appropriate adjustment for post-randomization predictors of adherence largely removes the association between adherence to placebo and mortality originally described in this trial. Trial registration ClinicalTrials.gov, Identifier: NCT00000482. Registered retrospectively on 27 October 1999. |
| first_indexed | 2024-04-12T21:50:11Z |
| format | Article |
| id | doaj.art-df988d152b194476be3f53a9ccc81a72 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T21:50:11Z |
| publishDate | 2018-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-df988d152b194476be3f53a9ccc81a722022-12-22T03:15:31ZengBMCTrials1745-62152018-03-011911410.1186/s13063-018-2519-5Improved adherence adjustment in the Coronary Drug ProjectEleanor J. Murray0Miguel A. Hernán1Department of Epidemiology, Harvard T.H. Chan School of Public HealthDepartment of Epidemiology, Harvard T.H. Chan School of Public HealthAbstract Background The survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full advantage of recent methodological developments. Methods We used inverse-probability weighted hazards models to estimate the 5-year survival and mortality risk when individuals in the placebo arm of the Coronary Drug Project adhere to at least 80% of the drug continuously or never during the 5-year follow-up period. Results Adjustment for post-randomization covariates resulted in 5-year mortality risk difference estimates ranging from − 0.7 (95% confidence intervals (CI), − 12.2, 10.7) to 4.5 (95% CI, − 6.3, 15.3) percentage points. Conclusions Our analysis confirms that appropriate adjustment for post-randomization predictors of adherence largely removes the association between adherence to placebo and mortality originally described in this trial. Trial registration ClinicalTrials.gov, Identifier: NCT00000482. Registered retrospectively on 27 October 1999.http://link.springer.com/article/10.1186/s13063-018-2519-5Per-protocol effectIntention-to-treat effectInverse-probability weightingCoronary Drug ProjectAdherence |
| spellingShingle | Eleanor J. Murray Miguel A. Hernán Improved adherence adjustment in the Coronary Drug Project Trials Per-protocol effect Intention-to-treat effect Inverse-probability weighting Coronary Drug Project Adherence |
| title | Improved adherence adjustment in the Coronary Drug Project |
| title_full | Improved adherence adjustment in the Coronary Drug Project |
| title_fullStr | Improved adherence adjustment in the Coronary Drug Project |
| title_full_unstemmed | Improved adherence adjustment in the Coronary Drug Project |
| title_short | Improved adherence adjustment in the Coronary Drug Project |
| title_sort | improved adherence adjustment in the coronary drug project |
| topic | Per-protocol effect Intention-to-treat effect Inverse-probability weighting Coronary Drug Project Adherence |
| url | http://link.springer.com/article/10.1186/s13063-018-2519-5 |
| work_keys_str_mv | AT eleanorjmurray improvedadherenceadjustmentinthecoronarydrugproject AT miguelahernan improvedadherenceadjustmentinthecoronarydrugproject |