When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline
The present study randomly assigned 15 Bahamian elementary schools to one of three intervention conditions. To assess the adequacy of cluster randomization, we examined two concerns identified by the local research team: inequality of gender distribution and environmental risk among groups. Baseline...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2012-01-01
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| Series: | AIDS Research and Treatment |
| Online Access: | http://dx.doi.org/10.1155/2012/806384 |
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| _version_ | 1832552354387329024 |
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| author | Veronica Dinaj-Koci Nanika Brathwaite Lynette Deveaux Sonya Lunn Lesley Cottrell Carole Harris Bonita Stanton Xiaoming Li Sharon Marshall Perry Gomez Xinguang Chen |
| author_facet | Veronica Dinaj-Koci Nanika Brathwaite Lynette Deveaux Sonya Lunn Lesley Cottrell Carole Harris Bonita Stanton Xiaoming Li Sharon Marshall Perry Gomez Xinguang Chen |
| author_sort | Veronica Dinaj-Koci |
| collection | DOAJ |
| description | The present study randomly assigned 15 Bahamian elementary schools to one of three intervention conditions. To assess the adequacy of cluster randomization, we examined two concerns identified by the local research team: inequality of gender distribution and environmental risk among groups. Baseline significant differences in risk and protective behaviors were minimal. There were significantly more males in the intervention group. Males had higher rates of risk behavior at all assessments. Poor school performance was also higher among the intervention condition and was significantly associated with increased rates of many but not all risk behaviors. Prior to adjusting for gender and school performance, several risk behaviors appeared to be higher after intervention among intervention youth. Adjusting for gender and school performance eradicated the group differences in risk behavior rates. Results demonstrate the importance of adequate randomization where outcomes of interest are rare events at baseline or differ by gender and there is an unequal gender distribution and the importance of the local research team’s knowledge of potential inequalities in environmental risk (i.e., school performance). Not considering such individual differences could impact the integrity of trial outcomes. |
| format | Article |
| id | doaj-art-4e2d2fab858e4c66b73921bbeb8bf0fd |
| institution | Kabale University |
| issn | 2090-1240 2090-1259 |
| language | English |
| publishDate | 2012-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | AIDS Research and Treatment |
| spelling | doaj-art-4e2d2fab858e4c66b73921bbeb8bf0fd2025-02-03T05:58:48ZengWileyAIDS Research and Treatment2090-12402090-12592012-01-01201210.1155/2012/806384806384When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at BaselineVeronica Dinaj-Koci0Nanika Brathwaite1Lynette Deveaux2Sonya Lunn3Lesley Cottrell4Carole Harris5Bonita Stanton6Xiaoming Li7Sharon Marshall8Perry Gomez9Xinguang Chen10Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI 48201, USAThe Bahamas Ministries of Health and Education, New Providence, Nassau, BahamasThe Bahamas Ministries of Health and Education, New Providence, Nassau, BahamasThe Bahamas Ministries of Health and Education, New Providence, Nassau, BahamasDepartment of Pediatrics, West Virginia University School of Medicine, Morgantown, WV 26506, USAHealth Research Center, West Virginia University, Morgantown, WV 26506, USACarman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI 48201, USACarman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI 48201, USACarman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI 48201, USAThe Bahamas Ministries of Health and Education, New Providence, Nassau, BahamasCarman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI 48201, USAThe present study randomly assigned 15 Bahamian elementary schools to one of three intervention conditions. To assess the adequacy of cluster randomization, we examined two concerns identified by the local research team: inequality of gender distribution and environmental risk among groups. Baseline significant differences in risk and protective behaviors were minimal. There were significantly more males in the intervention group. Males had higher rates of risk behavior at all assessments. Poor school performance was also higher among the intervention condition and was significantly associated with increased rates of many but not all risk behaviors. Prior to adjusting for gender and school performance, several risk behaviors appeared to be higher after intervention among intervention youth. Adjusting for gender and school performance eradicated the group differences in risk behavior rates. Results demonstrate the importance of adequate randomization where outcomes of interest are rare events at baseline or differ by gender and there is an unequal gender distribution and the importance of the local research team’s knowledge of potential inequalities in environmental risk (i.e., school performance). Not considering such individual differences could impact the integrity of trial outcomes.http://dx.doi.org/10.1155/2012/806384 |
| spellingShingle | Veronica Dinaj-Koci Nanika Brathwaite Lynette Deveaux Sonya Lunn Lesley Cottrell Carole Harris Bonita Stanton Xiaoming Li Sharon Marshall Perry Gomez Xinguang Chen When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline AIDS Research and Treatment |
| title | When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline |
| title_full | When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline |
| title_fullStr | When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline |
| title_full_unstemmed | When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline |
| title_short | When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline |
| title_sort | when things are not as they appear assessing the adequacy of cluster randomization when outcome events are rare at baseline |
| url | http://dx.doi.org/10.1155/2012/806384 |
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