Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing
Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provid...
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Journal of Diabetes Research |
| Online Access: | http://dx.doi.org/10.1155/2016/2720650 |
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| author | Barbro Lernmark Kristian Lynch Judith Baxter Roswith Roth Tuula Simell Laura Smith Ulrica Swartling Suzanne Bennett Johnson TEDDY Study Group |
| author_facet | Barbro Lernmark Kristian Lynch Judith Baxter Roswith Roth Tuula Simell Laura Smith Ulrica Swartling Suzanne Bennett Johnson TEDDY Study Group |
| author_sort | Barbro Lernmark |
| collection | DOAJ |
| description | Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n=1220). Most families were AW (n=1549; 73.4%). PW was more common in the United States (n=1001; 37.8%) and among young mothers (p=0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Conclusions. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal. |
| format | Article |
| id | doaj-art-c7e28c4995524174a63172cb516d7f09 |
| institution | Kabale University |
| issn | 2314-6745 2314-6753 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Research |
| spelling | doaj-art-c7e28c4995524174a63172cb516d7f092025-02-03T05:48:13ZengWileyJournal of Diabetes Research2314-67452314-67532016-01-01201610.1155/2016/27206502720650Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for WithdrawingBarbro Lernmark0Kristian Lynch1Judith Baxter2Roswith Roth3Tuula Simell4Laura Smith5Ulrica Swartling6Suzanne Bennett Johnson7TEDDY Study Group8Department of Clinical Sciences, Lund University, CRC, Jan Waldenströms Gata 35, Skåne University Hospital (SUS), 20502 Malmö, SwedenHealth Informatics Institute, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USABarbara Davis Center for Childhood Diabetes, School of Medicine, University of Colorado Denver-AMC, 1775 Aurora Court, Aurora, CO 80045, USAInstitute of Diabetes Research, Helmholtz Center Munich and Clinic on the right of Isar, Technical University Munich, Research Group Diabetes e.V., Ingolstaedter Landstrasse 1, 85764 Neuherberg, GermanyDepartment of Pediatrics, University of Turku, Kiinamyllynkatu 4-8, 20100 Turku, FinlandHealth Informatics Institute, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USADepartment of Clinical Sciences, Lund University, CRC, Jan Waldenströms Gata 35, Skåne University Hospital (SUS), 20502 Malmö, SwedenDepartment of Medical Humanities and Social Sciences, Florida State University College of Medicine, 1115 West Call Street, Tallahassee, FL 32306, USADepartment of Clinical Sciences, Lund University, CRC, Jan Waldenströms Gata 35, Skåne University Hospital (SUS), 20502 Malmö, SwedenBackground. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n=1220). Most families were AW (n=1549; 73.4%). PW was more common in the United States (n=1001; 37.8%) and among young mothers (p=0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Conclusions. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.http://dx.doi.org/10.1155/2016/2720650 |
| spellingShingle | Barbro Lernmark Kristian Lynch Judith Baxter Roswith Roth Tuula Simell Laura Smith Ulrica Swartling Suzanne Bennett Johnson TEDDY Study Group Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing Journal of Diabetes Research |
| title | Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing |
| title_full | Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing |
| title_fullStr | Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing |
| title_full_unstemmed | Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing |
| title_short | Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing |
| title_sort | participant experiences in the environmental determinants of diabetes in the young study common reasons for withdrawing |
| url | http://dx.doi.org/10.1155/2016/2720650 |
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