Cargando…
How do trial teams plan for retention during the design stage of the trial? A scoping review protocol
BACKGROUND: Retention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be included in the trial protocol “Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for...
Autores principales: | , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670576/ https://www.ncbi.nlm.nih.gov/pubmed/36397085 http://dx.doi.org/10.1186/s13063-022-06866-w |
_version_ | 1784832364387500032 |
---|---|
author | Murphy, Ellen Gillies, Katie Shiely, Frances |
author_facet | Murphy, Ellen Gillies, Katie Shiely, Frances |
author_sort | Murphy, Ellen |
collection | PubMed |
description | BACKGROUND: Retention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be included in the trial protocol “Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols”. This guidance shows the importance of planning retention methods and handling missing data as this can impact how the results of the trial are interpreted. The most recent Cochrane review of strategies to improve retention in clinical trials highlighted that some trials implemented multiple retention strategies and we questioned whether the use of multiple strategies was planned at the design stage and included in the protocol or are strategies implemented when retention becomes an issue within the trial. The purpose of our scoping review is to establish if and how trial teams prepare for retention at the design phase of clinical trials. METHODS AND ANALYSIS: We will follow the methodological framework and guidelines for scoping reviews outlined by the Joanna Briggs Institute. We will search MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science. A comprehensive search strategy for PubMed was developed in collaboration with an experienced research librarian. We will include protocols for phase 2, 3, and 4 RCTs as well as pilot and feasibility studies. The screening process will involve two reviewers. EM will independently screen all titles and abstracts. FS will screen 10% of the overall search output, and where necessary full protocol texts will be screened to determine eligibility. We will randomly sample eligible protocols to ensure the protocols represent a variety of trial and intervention types. Data will be extracted from each protocol and the results will be synthesised. The analysis will be qualitative using a narrative summary and descriptive statistics where appropriate. DISCUSSION: The scoping review will help trial methodologists better understand if retention strategies are planned for during the design stage of the trial contributing to the PRioRiTy II unanswered question “How should people who run trials plan for retention during their funding application and creation of the trial (protocol development)?”. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06866-w. |
format | Online Article Text |
id | pubmed-9670576 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-96705762022-11-18 How do trial teams plan for retention during the design stage of the trial? A scoping review protocol Murphy, Ellen Gillies, Katie Shiely, Frances Trials Study Protocol BACKGROUND: Retention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be included in the trial protocol “Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols”. This guidance shows the importance of planning retention methods and handling missing data as this can impact how the results of the trial are interpreted. The most recent Cochrane review of strategies to improve retention in clinical trials highlighted that some trials implemented multiple retention strategies and we questioned whether the use of multiple strategies was planned at the design stage and included in the protocol or are strategies implemented when retention becomes an issue within the trial. The purpose of our scoping review is to establish if and how trial teams prepare for retention at the design phase of clinical trials. METHODS AND ANALYSIS: We will follow the methodological framework and guidelines for scoping reviews outlined by the Joanna Briggs Institute. We will search MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science. A comprehensive search strategy for PubMed was developed in collaboration with an experienced research librarian. We will include protocols for phase 2, 3, and 4 RCTs as well as pilot and feasibility studies. The screening process will involve two reviewers. EM will independently screen all titles and abstracts. FS will screen 10% of the overall search output, and where necessary full protocol texts will be screened to determine eligibility. We will randomly sample eligible protocols to ensure the protocols represent a variety of trial and intervention types. Data will be extracted from each protocol and the results will be synthesised. The analysis will be qualitative using a narrative summary and descriptive statistics where appropriate. DISCUSSION: The scoping review will help trial methodologists better understand if retention strategies are planned for during the design stage of the trial contributing to the PRioRiTy II unanswered question “How should people who run trials plan for retention during their funding application and creation of the trial (protocol development)?”. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06866-w. BioMed Central 2022-11-17 /pmc/articles/PMC9670576/ /pubmed/36397085 http://dx.doi.org/10.1186/s13063-022-06866-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Murphy, Ellen Gillies, Katie Shiely, Frances How do trial teams plan for retention during the design stage of the trial? A scoping review protocol |
title | How do trial teams plan for retention during the design stage of the trial? A scoping review protocol |
title_full | How do trial teams plan for retention during the design stage of the trial? A scoping review protocol |
title_fullStr | How do trial teams plan for retention during the design stage of the trial? A scoping review protocol |
title_full_unstemmed | How do trial teams plan for retention during the design stage of the trial? A scoping review protocol |
title_short | How do trial teams plan for retention during the design stage of the trial? A scoping review protocol |
title_sort | how do trial teams plan for retention during the design stage of the trial? a scoping review protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670576/ https://www.ncbi.nlm.nih.gov/pubmed/36397085 http://dx.doi.org/10.1186/s13063-022-06866-w |
work_keys_str_mv | AT murphyellen howdotrialteamsplanforretentionduringthedesignstageofthetrialascopingreviewprotocol AT gillieskatie howdotrialteamsplanforretentionduringthedesignstageofthetrialascopingreviewprotocol AT shielyfrances howdotrialteamsplanforretentionduringthedesignstageofthetrialascopingreviewprotocol |