Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness
<p>Abstract</p> <p>Background</p> <p>In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2004-10-01
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| Series: | BMC Medical Research Methodology |
| Online Access: | http://www.biomedcentral.com/1471-2288/4/23 |
| _version_ | 1818824747052433408 |
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| author | Martens Mark Wan Livia Poindexter Alfred Creinin Mitchell D Bradley Lynn Barnhart Kurt T Luoto Joanne Pierre-Louis Bosny Chen Pai Raymond Elizabeth G Schenken Robert Nicholas Cate F Blackwell Richard |
| author_facet | Martens Mark Wan Livia Poindexter Alfred Creinin Mitchell D Bradley Lynn Barnhart Kurt T Luoto Joanne Pierre-Louis Bosny Chen Pai Raymond Elizabeth G Schenken Robert Nicholas Cate F Blackwell Richard |
| author_sort | Martens Mark |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy.</p> <p>Methods</p> <p>Trial participants were expected to use the assigned spermicide for contraception for 7 months or until pregnancy occurred. In bivariable and multivariable analyses, we assessed the associations between failure to complete the trial and 17 pre-specified baseline characteristics. In addition, among women who participated for at least 6 weeks, we evaluated the relationships between failure to complete, various features of their first 6 weeks of experience with the spermicide, and characteristics of the study centers and population.</p> <p>Results</p> <p>Of the 1514 participants in this analysis, 635 (42%) failed to complete the study for reasons other than pregnancy. Women were significantly less likely to complete if they were younger or unmarried, had intercourse at least 8 times per month, or were enrolled at a university center or at a center that enrolled fewer than 4 participants per month. Noncompliance with study procedures in the first 6 weeks was also associated with subsequent early withdrawal, but dissatisfaction with the spermicide was not. However, many participants without these risk factors withdrew early.</p> <p>Conclusions</p> <p>Failure to complete is a major problem in barrier method trials that seriously compromises the interpretation of results. Targeting retention efforts at women at high risk for early withdrawal is not likely to address the problem sufficiently.</p> |
| first_indexed | 2024-12-19T00:00:47Z |
| format | Article |
| id | doaj.art-53ad1259845243d18917909316547bb8 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-12-19T00:00:47Z |
| publishDate | 2004-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-53ad1259845243d18917909316547bb82022-12-21T20:46:27ZengBMCBMC Medical Research Methodology1471-22882004-10-01412310.1186/1471-2288-4-23Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectivenessMartens MarkWan LiviaPoindexter AlfredCreinin Mitchell DBradley LynnBarnhart Kurt TLuoto JoannePierre-Louis BosnyChen PaiRaymond Elizabeth GSchenken RobertNicholas Cate FBlackwell Richard<p>Abstract</p> <p>Background</p> <p>In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy.</p> <p>Methods</p> <p>Trial participants were expected to use the assigned spermicide for contraception for 7 months or until pregnancy occurred. In bivariable and multivariable analyses, we assessed the associations between failure to complete the trial and 17 pre-specified baseline characteristics. In addition, among women who participated for at least 6 weeks, we evaluated the relationships between failure to complete, various features of their first 6 weeks of experience with the spermicide, and characteristics of the study centers and population.</p> <p>Results</p> <p>Of the 1514 participants in this analysis, 635 (42%) failed to complete the study for reasons other than pregnancy. Women were significantly less likely to complete if they were younger or unmarried, had intercourse at least 8 times per month, or were enrolled at a university center or at a center that enrolled fewer than 4 participants per month. Noncompliance with study procedures in the first 6 weeks was also associated with subsequent early withdrawal, but dissatisfaction with the spermicide was not. However, many participants without these risk factors withdrew early.</p> <p>Conclusions</p> <p>Failure to complete is a major problem in barrier method trials that seriously compromises the interpretation of results. Targeting retention efforts at women at high risk for early withdrawal is not likely to address the problem sufficiently.</p>http://www.biomedcentral.com/1471-2288/4/23 |
| spellingShingle | Martens Mark Wan Livia Poindexter Alfred Creinin Mitchell D Bradley Lynn Barnhart Kurt T Luoto Joanne Pierre-Louis Bosny Chen Pai Raymond Elizabeth G Schenken Robert Nicholas Cate F Blackwell Richard Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness BMC Medical Research Methodology |
| title | Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness |
| title_full | Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness |
| title_fullStr | Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness |
| title_full_unstemmed | Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness |
| title_short | Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness |
| title_sort | participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness |
| url | http://www.biomedcentral.com/1471-2288/4/23 |
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