Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response
AbstractPurpose:Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evalu...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2019-08-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S205986611900400X/type/journal_article |
| _version_ | 1811156831058264064 |
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| author | Sarah E. Brewer Elizabeth J. Campagna Elaine H. Morrato |
| author_facet | Sarah E. Brewer Elizabeth J. Campagna Elaine H. Morrato |
| author_sort | Sarah E. Brewer |
| collection | DOAJ |
| description | AbstractPurpose:Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies.Methods:A systematic literature review was conducted of US physician surveys (2000–2014) on pharmaceutical use (n = 75). Kruskal–Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson’s chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks).Results:Survey response rates ranged from 7% to 100% (median = 48%, IQR = 34%–68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items).Conclusions:Published data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias. |
| first_indexed | 2024-04-10T04:56:35Z |
| format | Article |
| id | doaj.art-111ef79562b14ae3830e68ff6f53c29a |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:56:35Z |
| publishDate | 2019-08-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-111ef79562b14ae3830e68ff6f53c29a2023-03-09T12:29:46ZengCambridge University PressJournal of Clinical and Translational Science2059-86612019-08-01319920910.1017/cts.2019.400Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey responseSarah E. Brewer0https://orcid.org/0000-0003-0063-6626Elizabeth J. Campagna1Elaine H. Morrato2Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, Aurora, CO, USA Department of Family Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA Health and Behavioral Sciences, University of Colorado Denver, Denver, CO, USAAdult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, Aurora, CO, USAAdult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, Aurora, CO, USA Department of Health Systems, Management and Policy, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USAAbstractPurpose:Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies.Methods:A systematic literature review was conducted of US physician surveys (2000–2014) on pharmaceutical use (n = 75). Kruskal–Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson’s chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks).Results:Survey response rates ranged from 7% to 100% (median = 48%, IQR = 34%–68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items).Conclusions:Published data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias.https://www.cambridge.org/core/product/identifier/S205986611900400X/type/journal_articleCase illustrationmethodsphysician surveysprovider surveysresponse ratesrisk managementsystematic review |
| spellingShingle | Sarah E. Brewer Elizabeth J. Campagna Elaine H. Morrato Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response Journal of Clinical and Translational Science Case illustration methods physician surveys provider surveys response rates risk management systematic review |
| title | Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response |
| title_full | Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response |
| title_fullStr | Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response |
| title_full_unstemmed | Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response |
| title_short | Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response |
| title_sort | advancing regulatory science and assessment of fda rems programs a mixed methods evaluation examining physician survey response |
| topic | Case illustration methods physician surveys provider surveys response rates risk management systematic review |
| url | https://www.cambridge.org/core/product/identifier/S205986611900400X/type/journal_article |
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