Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set
Abstract Background The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However,...
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| Format: | Article |
| Language: | English |
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BMC
2018-11-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2986-8 |
| _version_ | 1818311855668461568 |
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| author | Liam J. Convie Scott McCain Jeffrey Campbell Stephen J. Kirk Mike Clarke |
| author_facet | Liam J. Convie Scott McCain Jeffrey Campbell Stephen J. Kirk Mike Clarke |
| author_sort | Liam J. Convie |
| collection | DOAJ |
| description | Abstract Background The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However, the definitions, methods of measurement and timing of measurement vary widely across the studies that have been done. Although a Cochrane review has reported that many of these interventions appear to work, the high level of heterogeneity in outcome reporting prevents the identification of those interventions that work best and why they do so. It is also not clear which outcomes are most important to each party involved in the consent process and why. Methods/design This project will develop a core outcome set for assessing the effects of interventions aimed at improving informed consent for surgery and other invasive procedures for adult patients with the capacity to consent for themselves. We will conduct a systematic review of the qualitative and quantitative literature to identify outcomes used to date in consent research and map these into domains. A series of semi-structured key stakeholder interviews will also be used to identify relevant outcomes. These processes will produce a list of potential outcomes for assessing the effects of interventions to improve consent, which will be refined through an international Delphi survey and consensus webinars involving key stakeholders to produce the core outcome set. Discussion The ICONS study aims to develop a core outcome set for use in trials and reviews of interventions designed to improve the informed consent process for surgery and other invasive procedures. Our aim is that this core outcome set will reduce the level of selection and reporting bias in consent research and help clinicians to compare tools to improve consent. |
| first_indexed | 2024-12-13T08:08:35Z |
| format | Article |
| id | doaj.art-4709f3a6639c44889e8227f4afc8f8b6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T08:08:35Z |
| publishDate | 2018-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4709f3a6639c44889e8227f4afc8f8b62022-12-21T23:54:16ZengBMCTrials1745-62152018-11-011911910.1186/s13063-018-2986-8Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome setLiam J. Convie0Scott McCain1Jeffrey Campbell2Stephen J. Kirk3Mike Clarke4Department of General Surgery, Ulster HospitalDepartment of General Surgery, Ulster HospitalDepartment of General Surgery, Ulster HospitalDepartment of General Surgery, Ulster HospitalCentre for Public Health, Queen’s University BelfastAbstract Background The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However, the definitions, methods of measurement and timing of measurement vary widely across the studies that have been done. Although a Cochrane review has reported that many of these interventions appear to work, the high level of heterogeneity in outcome reporting prevents the identification of those interventions that work best and why they do so. It is also not clear which outcomes are most important to each party involved in the consent process and why. Methods/design This project will develop a core outcome set for assessing the effects of interventions aimed at improving informed consent for surgery and other invasive procedures for adult patients with the capacity to consent for themselves. We will conduct a systematic review of the qualitative and quantitative literature to identify outcomes used to date in consent research and map these into domains. A series of semi-structured key stakeholder interviews will also be used to identify relevant outcomes. These processes will produce a list of potential outcomes for assessing the effects of interventions to improve consent, which will be refined through an international Delphi survey and consensus webinars involving key stakeholders to produce the core outcome set. Discussion The ICONS study aims to develop a core outcome set for use in trials and reviews of interventions designed to improve the informed consent process for surgery and other invasive procedures. Our aim is that this core outcome set will reduce the level of selection and reporting bias in consent research and help clinicians to compare tools to improve consent.http://link.springer.com/article/10.1186/s13063-018-2986-8Core outcome setsConsensus methodsInformed consentSurgery |
| spellingShingle | Liam J. Convie Scott McCain Jeffrey Campbell Stephen J. Kirk Mike Clarke Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set Trials Core outcome sets Consensus methods Informed consent Surgery |
| title | Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set |
| title_full | Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set |
| title_fullStr | Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set |
| title_full_unstemmed | Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set |
| title_short | Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set |
| title_sort | evaluating interventions for informed consent for surgery icons protocol for the development of a core outcome set |
| topic | Core outcome sets Consensus methods Informed consent Surgery |
| url | http://link.springer.com/article/10.1186/s13063-018-2986-8 |
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