Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development
Well established guidelines already exist that address best practices for Non-Interventional Study (NIS) design and methods. These guidelines provide advice on things to consider while designing a study and developing a protocol, but do not necessarily capture specific details related to the impleme...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Columbia Data Analytics, LLC
2017-04-01
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| Series: | Journal of Health Economics and Outcomes Research |
| Online Access: | https://doi.org/10.36469/9796 |
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| _version_ | 1823860360519614464 |
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| author | Juanzhi Fang Sara Bruce Wirta Kristijan Kahler |
| author_facet | Juanzhi Fang Sara Bruce Wirta Kristijan Kahler |
| author_sort | Juanzhi Fang |
| collection | DOAJ |
| description | Well established guidelines already exist that address best practices for Non-Interventional Study (NIS) design and methods. These guidelines provide advice on things to consider while designing a study and developing a protocol, but do not necessarily capture specific details related to the implementation of NIS. The intent of this paper is to propose a best practice for conducting secondary use of data NIS. We propose that the ideal implementation of a NIS should include the development of a strong Study Concept, followed by a detailed Protocol, Analysis Plan, Report, and considerations for Dissemination.
We review and discuss common mistakes/pitfalls and key considerations at each step from concept to publication. In many cases in this review, we have also provided suggestions or accessible resources that researchers can apply as a “best practices” guide when planning, conducting, or reviewing this investigative method. |
| format | Article |
| id | doaj-art-96e1eaed563f4036b26addf27bc42111 |
| institution | Kabale University |
| issn | 2327-2236 |
| language | English |
| publishDate | 2017-04-01 |
| publisher | Columbia Data Analytics, LLC |
| record_format | Article |
| series | Journal of Health Economics and Outcomes Research |
| spelling | doaj-art-96e1eaed563f4036b26addf27bc421112025-02-10T16:12:45ZengColumbia Data Analytics, LLCJournal of Health Economics and Outcomes Research2327-22362017-04-0151Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol DevelopmentJuanzhi FangSara Bruce WirtaKristijan KahlerWell established guidelines already exist that address best practices for Non-Interventional Study (NIS) design and methods. These guidelines provide advice on things to consider while designing a study and developing a protocol, but do not necessarily capture specific details related to the implementation of NIS. The intent of this paper is to propose a best practice for conducting secondary use of data NIS. We propose that the ideal implementation of a NIS should include the development of a strong Study Concept, followed by a detailed Protocol, Analysis Plan, Report, and considerations for Dissemination. We review and discuss common mistakes/pitfalls and key considerations at each step from concept to publication. In many cases in this review, we have also provided suggestions or accessible resources that researchers can apply as a “best practices” guide when planning, conducting, or reviewing this investigative method.https://doi.org/10.36469/9796 |
| spellingShingle | Juanzhi Fang Sara Bruce Wirta Kristijan Kahler Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development Journal of Health Economics and Outcomes Research |
| title | Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development |
| title_full | Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development |
| title_fullStr | Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development |
| title_full_unstemmed | Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development |
| title_short | Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development |
| title_sort | secondary use of data non interventional study best practices in planning and protocol development |
| url | https://doi.org/10.36469/9796 |
| work_keys_str_mv | AT juanzhifang secondaryuseofdatanoninterventionalstudybestpracticesinplanningandprotocoldevelopment AT sarabrucewirta secondaryuseofdatanoninterventionalstudybestpracticesinplanningandprotocoldevelopment AT kristijankahler secondaryuseofdatanoninterventionalstudybestpracticesinplanningandprotocoldevelopment |