Determining information for inclusion in a decision-support intervention for clinical trial participation

A modified Delphi approach

Research output: Contribution to journalArticle

13 Citations (Scopus)
6 Downloads (Pure)

Abstract

Background The use of decision-support interventions in the context of decisions about trial participation is an emergent field. There is a lack of evidence about what information is deemed important to support decisions about informed consent for clinical trials, and whether different groups agree on the information for inclusion.
Purpose The overall objective was to determine the items which different stakeholder groups viewed to be important for inclusion in a decision-support tool when making decisions about clinical trial participation, with a view to use these as a framework for developing decision-support tools in this context. This is the first study to have addressed this issue.
Methods A modified Delphi method was used to determine agreement on importance of items. The ‘stakeholder’ panel was made up of 49 individuals from 5 groups: 11 trialists, 6 research nurses, 7 ethics committee chairs, 9 decision-support experts, and 16 patients (9 trial experienced and 7 trial non-experienced). Two rounds of rating were completed. Items with a median of 7–10 with ≥65% of any one group (from aggregate ratings) in agreement were considered important for inclusion.
Results The stakeholder panel achieved consensus on the majority of items included (60/66), agreeing that these were important for inclusion in a decision-support tool for trial participation. These included items covering information about trial participation and standard care, information on the likelihood of receiving different treatments, information to help patients determine what matters most to them, ensuring that the information is balanced, guidance on how to make a decision, disclosure of any conflicts of interest, using plain language in the tool, and guidance on the decision-support development process. Some areas of divergence among the panel were also identified relating to the use of patient stories.
Limitations Selection bias may be a limitation in this study due to the manner in which the participants were invited to take part, and therefore, the representativeness, and reproducibility with another group of stakeholders, may differ.
Conclusions Agreement was obtained on a number of items, which we recommend should be used as a framework to develop useful tools to support decision-making about participation in clinical trials.
Original languageEnglish
Pages (from-to)967-976
Number of pages10
JournalClinical Trials
Volume10
Issue number6
Early online date4 Nov 2013
DOIs
Publication statusPublished - Dec 2013

Fingerprint

Clinical Trials
Decision Making
Conflict of Interest
Ethics Committees
Selection Bias
Disclosure
Informed Consent
Consensus
Language
Nurses
Research
Therapeutics

Cite this

@article{19103feec3f04457ab3a3fa4f7cf2356,
title = "Determining information for inclusion in a decision-support intervention for clinical trial participation: A modified Delphi approach",
abstract = "Background The use of decision-support interventions in the context of decisions about trial participation is an emergent field. There is a lack of evidence about what information is deemed important to support decisions about informed consent for clinical trials, and whether different groups agree on the information for inclusion.Purpose The overall objective was to determine the items which different stakeholder groups viewed to be important for inclusion in a decision-support tool when making decisions about clinical trial participation, with a view to use these as a framework for developing decision-support tools in this context. This is the first study to have addressed this issue.Methods A modified Delphi method was used to determine agreement on importance of items. The ‘stakeholder’ panel was made up of 49 individuals from 5 groups: 11 trialists, 6 research nurses, 7 ethics committee chairs, 9 decision-support experts, and 16 patients (9 trial experienced and 7 trial non-experienced). Two rounds of rating were completed. Items with a median of 7–10 with ≥65{\%} of any one group (from aggregate ratings) in agreement were considered important for inclusion.Results The stakeholder panel achieved consensus on the majority of items included (60/66), agreeing that these were important for inclusion in a decision-support tool for trial participation. These included items covering information about trial participation and standard care, information on the likelihood of receiving different treatments, information to help patients determine what matters most to them, ensuring that the information is balanced, guidance on how to make a decision, disclosure of any conflicts of interest, using plain language in the tool, and guidance on the decision-support development process. Some areas of divergence among the panel were also identified relating to the use of patient stories.Limitations Selection bias may be a limitation in this study due to the manner in which the participants were invited to take part, and therefore, the representativeness, and reproducibility with another group of stakeholders, may differ.Conclusions Agreement was obtained on a number of items, which we recommend should be used as a framework to develop useful tools to support decision-making about participation in clinical trials.",
author = "Kate Gillies and Skea, {Zo{\"e} C} and Maclennan, {Sara J} and Ramsay, {Craig R} and Campbell, {Marion K}",
year = "2013",
month = "12",
doi = "10.1177/1740774513508339",
language = "English",
volume = "10",
pages = "967--976",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "Sage Publications",
number = "6",

}

TY - JOUR

T1 - Determining information for inclusion in a decision-support intervention for clinical trial participation

T2 - A modified Delphi approach

AU - Gillies, Kate

AU - Skea, Zoë C

AU - Maclennan, Sara J

AU - Ramsay, Craig R

AU - Campbell, Marion K

PY - 2013/12

Y1 - 2013/12

N2 - Background The use of decision-support interventions in the context of decisions about trial participation is an emergent field. There is a lack of evidence about what information is deemed important to support decisions about informed consent for clinical trials, and whether different groups agree on the information for inclusion.Purpose The overall objective was to determine the items which different stakeholder groups viewed to be important for inclusion in a decision-support tool when making decisions about clinical trial participation, with a view to use these as a framework for developing decision-support tools in this context. This is the first study to have addressed this issue.Methods A modified Delphi method was used to determine agreement on importance of items. The ‘stakeholder’ panel was made up of 49 individuals from 5 groups: 11 trialists, 6 research nurses, 7 ethics committee chairs, 9 decision-support experts, and 16 patients (9 trial experienced and 7 trial non-experienced). Two rounds of rating were completed. Items with a median of 7–10 with ≥65% of any one group (from aggregate ratings) in agreement were considered important for inclusion.Results The stakeholder panel achieved consensus on the majority of items included (60/66), agreeing that these were important for inclusion in a decision-support tool for trial participation. These included items covering information about trial participation and standard care, information on the likelihood of receiving different treatments, information to help patients determine what matters most to them, ensuring that the information is balanced, guidance on how to make a decision, disclosure of any conflicts of interest, using plain language in the tool, and guidance on the decision-support development process. Some areas of divergence among the panel were also identified relating to the use of patient stories.Limitations Selection bias may be a limitation in this study due to the manner in which the participants were invited to take part, and therefore, the representativeness, and reproducibility with another group of stakeholders, may differ.Conclusions Agreement was obtained on a number of items, which we recommend should be used as a framework to develop useful tools to support decision-making about participation in clinical trials.

AB - Background The use of decision-support interventions in the context of decisions about trial participation is an emergent field. There is a lack of evidence about what information is deemed important to support decisions about informed consent for clinical trials, and whether different groups agree on the information for inclusion.Purpose The overall objective was to determine the items which different stakeholder groups viewed to be important for inclusion in a decision-support tool when making decisions about clinical trial participation, with a view to use these as a framework for developing decision-support tools in this context. This is the first study to have addressed this issue.Methods A modified Delphi method was used to determine agreement on importance of items. The ‘stakeholder’ panel was made up of 49 individuals from 5 groups: 11 trialists, 6 research nurses, 7 ethics committee chairs, 9 decision-support experts, and 16 patients (9 trial experienced and 7 trial non-experienced). Two rounds of rating were completed. Items with a median of 7–10 with ≥65% of any one group (from aggregate ratings) in agreement were considered important for inclusion.Results The stakeholder panel achieved consensus on the majority of items included (60/66), agreeing that these were important for inclusion in a decision-support tool for trial participation. These included items covering information about trial participation and standard care, information on the likelihood of receiving different treatments, information to help patients determine what matters most to them, ensuring that the information is balanced, guidance on how to make a decision, disclosure of any conflicts of interest, using plain language in the tool, and guidance on the decision-support development process. Some areas of divergence among the panel were also identified relating to the use of patient stories.Limitations Selection bias may be a limitation in this study due to the manner in which the participants were invited to take part, and therefore, the representativeness, and reproducibility with another group of stakeholders, may differ.Conclusions Agreement was obtained on a number of items, which we recommend should be used as a framework to develop useful tools to support decision-making about participation in clinical trials.

U2 - 10.1177/1740774513508339

DO - 10.1177/1740774513508339

M3 - Article

VL - 10

SP - 967

EP - 976

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 6

ER -