Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines
Abstract Background N-of-1 trials are multiple cross-over trials done in individual participants, generating individual treatment effect information. While reporting guidelines for the CONSORT Extension for N-of-1 trials (CENT) and the Standard Protocol Items: Recommendations for Interventional Tria...
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | Systematic Reviews |
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| Online Access: | http://link.springer.com/article/10.1186/s13643-017-0525-4 |
| _version_ | 1811324989339598848 |
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| author | Antony J. Porcino Salima Punja An-Wen Chan Richard Kravitz Aaron Orkin Philippe Ravaud Christopher H. Schmid Sunita Vohra |
| author_facet | Antony J. Porcino Salima Punja An-Wen Chan Richard Kravitz Aaron Orkin Philippe Ravaud Christopher H. Schmid Sunita Vohra |
| author_sort | Antony J. Porcino |
| collection | DOAJ |
| description | Abstract Background N-of-1 trials are multiple cross-over trials done in individual participants, generating individual treatment effect information. While reporting guidelines for the CONSORT Extension for N-of-1 trials (CENT) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) already exist, there is no standardized recommendation for the reporting of N-of-1 trial protocols. Objective The objective of this study is to evaluate current literature on N-of-1 design and reporting to identify key elements of rigorous N-of-1 protocol design. Methods We will conduct a systematic search for all N-of-1 trial guidelines and protocol-reporting guidelines published in peer-reviewed literature. We will search Medline, Embase, PsycINFO, CINAHL, the Cochrane Methodology Register, CENTRAL, and the NHS Economic Evaluation Database. Eligible articles will contain explicit guidance on N-of-1 protocol construction or reporting. Two reviewers will independently screen all titles and abstracts and then undertake full-text reviews of potential articles to determine eligibility. One reviewer will perform data extraction of selected articles, checked by the second reviewer. Data analysis will ascertain common features of N-of-1 trial protocols and compare them to the SPIRIT and CENT items. Discussion This systematic review assesses recommendations on the design and reporting of N-of-1 trial protocols. These findings will inform an international Delphi development process for an N-of-1 trial protocol reporting guideline. The development of this guideline is critical for improving the quality of N-of-1 protocols, leading to improvements in the quality of published N-of-1 trial research. |
| first_indexed | 2024-04-13T14:25:18Z |
| format | Article |
| id | doaj.art-796db30d5665411a8d239fc391759a45 |
| institution | Directory Open Access Journal |
| issn | 2046-4053 |
| language | English |
| last_indexed | 2024-04-13T14:25:18Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Systematic Reviews |
| spelling | doaj.art-796db30d5665411a8d239fc391759a452022-12-22T02:43:20ZengBMCSystematic Reviews2046-40532017-07-01611510.1186/s13643-017-0525-4Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelinesAntony J. Porcino0Salima Punja1An-Wen Chan2Richard Kravitz3Aaron Orkin4Philippe Ravaud5Christopher H. Schmid6Sunita Vohra7CARE Program, Department of Pediatrics, Faculty of Medicine and Dentistry, and Integrative Health Institute, University of AlbertaCARE Program, Department of Pediatrics, Faculty of Medicine and Dentistry, and Integrative Health Institute, University of AlbertaWomen’s College Research Institute, Women’s College Hospital, Department of Medicine, University of TorontoUC Davis Department of Internal MedicineDalla Lana School of Public Health, University of TorontoEQUATOR France, Centre d’épidémiologie clinique, Hôpital Hôtel-DieuCenter for Evidence Based Medicine, School of Public Health, Brown UniversityCARE Program, Department of Pediatrics, Faculty of Medicine and Dentistry, and Integrative Health Institute, University of AlbertaAbstract Background N-of-1 trials are multiple cross-over trials done in individual participants, generating individual treatment effect information. While reporting guidelines for the CONSORT Extension for N-of-1 trials (CENT) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) already exist, there is no standardized recommendation for the reporting of N-of-1 trial protocols. Objective The objective of this study is to evaluate current literature on N-of-1 design and reporting to identify key elements of rigorous N-of-1 protocol design. Methods We will conduct a systematic search for all N-of-1 trial guidelines and protocol-reporting guidelines published in peer-reviewed literature. We will search Medline, Embase, PsycINFO, CINAHL, the Cochrane Methodology Register, CENTRAL, and the NHS Economic Evaluation Database. Eligible articles will contain explicit guidance on N-of-1 protocol construction or reporting. Two reviewers will independently screen all titles and abstracts and then undertake full-text reviews of potential articles to determine eligibility. One reviewer will perform data extraction of selected articles, checked by the second reviewer. Data analysis will ascertain common features of N-of-1 trial protocols and compare them to the SPIRIT and CENT items. Discussion This systematic review assesses recommendations on the design and reporting of N-of-1 trial protocols. These findings will inform an international Delphi development process for an N-of-1 trial protocol reporting guideline. The development of this guideline is critical for improving the quality of N-of-1 protocols, leading to improvements in the quality of published N-of-1 trial research.http://link.springer.com/article/10.1186/s13643-017-0525-4Systematic reviewN-of-1 trialsClinical protocolsGuidelinesSingle case experimental designs |
| spellingShingle | Antony J. Porcino Salima Punja An-Wen Chan Richard Kravitz Aaron Orkin Philippe Ravaud Christopher H. Schmid Sunita Vohra Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines Systematic Reviews Systematic review N-of-1 trials Clinical protocols Guidelines Single case experimental designs |
| title | Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines |
| title_full | Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines |
| title_fullStr | Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines |
| title_full_unstemmed | Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines |
| title_short | Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines |
| title_sort | protocol for a systematic review of n of 1 trial protocol guidelines and protocol reporting guidelines |
| topic | Systematic review N-of-1 trials Clinical protocols Guidelines Single case experimental designs |
| url | http://link.springer.com/article/10.1186/s13643-017-0525-4 |
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