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Review
. 2024 Jan;8(1):e30-e37.
doi: 10.3928/24748307-20240218-01. Epub 2024 Mar 7.

Development of a New Tool for Writing Research Key Information in Plain Language

Sabrina Kurtz-Rossi, Ifechi Augusta Okonkwo, Ye Chen, Noe Dueñas, Timothy Bilodeau, Alice Rushforth, Andreas Klein
Review

Development of a New Tool for Writing Research Key Information in Plain Language

Sabrina Kurtz-Rossi et al. Health Lit Res Pract. 2024 Jan.

Abstract

Background: The complexity of research informed consent forms makes it hard for potential study participants to make informed consent decisions. In response, new rules for human research protection require informed consent forms to begin with a key information section that potential study participants can read and understand. This research study builds on exiting guidance on how to write research key information using plain language.

Objective: The aim of this study was to develop a valid and reliable tool to evaluate and improve the readability, understandability, and actionability of the key information section on research informed consent forms.

Methods: We developed an initial list of measures to include on the tool through literature review; established face and content validity of measures with expert input; conducted four rounds of reliability testing with four groups of reviewers; and established construct validity with potential research participants.

Key results: We identified 87 candidate measures via literature review. After expert review, we included 23 items on the initial tool. Twenty-four raters conducted 4 rounds of reliability testing on 10 informed consent forms. After each round, we revised or eliminated items to improve agreement. In the final round of testing, 18 items demonstrated substantial inter-rater agreement per Fleiss' Kappa (average = .73) and Gwet's AC1 (average = .77). Intra-rater agreement was substantial per Cohen's Kappa (average = .74) and almost perfect per Gwet's AC1 (average = 0.84). Focus group feedback (N = 16) provided evidence suggesting key information was easy to read when rated as such by the Readability, Understandability and Actionability of Key Information (RUAKI) Indicator.

Conclusion: The RUAKI Indicator is an 18-item tool with evidence of validity and reliability investigators can use to write the key information section on their informed consent forms that potential study participants can read, understand, and act on to make informed decisions. [HLRP: Health Literacy Research and Practice. 2024;8(1):e29-e37.].

Plain language summary

Research informed consent forms describe key information about research studies. People need this information to decide if they want to be in a study or not. A helpful form begins with a short, easy-to-read key information section. This study created a tool researchers can use to write the key information about their research people can read, understand, and use.

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Figures

Figure A.
Figure A.
18-item tool designed to assess the readability, understandability, and actionability of key information on research informed consent forms. 1 Office for Human Research Protection (OHRP). (, March 10). 2018 Requirements (2018 Common Rule). 46.116 General Requirements for Informed Consent. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.116
Figure A.
Figure A.
18-item tool designed to assess the readability, understandability, and actionability of key information on research informed consent forms. 1 Office for Human Research Protection (OHRP). (, March 10). 2018 Requirements (2018 Common Rule). 46.116 General Requirements for Informed Consent. HHS.gov. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.116
Figure B.
Figure B.
Participant Survey. Includes 5-point Decisional Conflict Scale, and questions to assess reading ease or difficulty, understanding, and demographics.
Figure B.
Figure B.
Participant Survey. Includes 5-point Decisional Conflict Scale, and questions to assess reading ease or difficulty, understanding, and demographics.
Figure B.
Figure B.
Participant Survey. Includes 5-point Decisional Conflict Scale, and questions to assess reading ease or difficulty, understanding, and demographics.
See this image and copyright information in PMC

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