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Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study

BACKGROUND: There is substantial prior research on the perspectives of patients on the use of health information for research. Numerous communication barriers challenge transparency between researchers and data participants in secondary database research (eg, waiver of informed consent and knowledge...

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Autores principales: Schmit, Cason, Ajayi, Kobi V, Ferdinand, Alva O, Giannouchos, Theodoros, Ilangovan, Gurudev, Nowell, W Benjamin, Kum, Hye-Chung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772068/
https://www.ncbi.nlm.nih.gov/pubmed/33320097
http://dx.doi.org/10.2196/20783
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author Schmit, Cason
Ajayi, Kobi V
Ferdinand, Alva O
Giannouchos, Theodoros
Ilangovan, Gurudev
Nowell, W Benjamin
Kum, Hye-Chung
author_facet Schmit, Cason
Ajayi, Kobi V
Ferdinand, Alva O
Giannouchos, Theodoros
Ilangovan, Gurudev
Nowell, W Benjamin
Kum, Hye-Chung
author_sort Schmit, Cason
collection PubMed
description BACKGROUND: There is substantial prior research on the perspectives of patients on the use of health information for research. Numerous communication barriers challenge transparency between researchers and data participants in secondary database research (eg, waiver of informed consent and knowledge gaps). Individual concerns and misconceptions challenge the trust in researchers among patients despite efforts to protect data. Technical software used to protect research data can further complicate the public's understanding of research. For example, MiNDFIRL (Minimum Necessary Disclosure For Interactive Record Linkage) is a prototype software that can be used to enhance the confidentiality of data sets by restricting disclosures of identifying information during the record linkage process. However, software, such as MiNDFIRL, which is used to protect data, must overcome the aforementioned communication barriers. One proposed solution is the creation of an interactive web-based frequently asked question (FAQ) template that can be adapted and used to communicate research issues to data subjects. OBJECTIVE: This study aims to improve communication with patients and transparency about how complex software, such as MiNDFIRL, is used to enhance privacy in secondary database studies to maintain the public's trust in researchers. METHODS: A Delphi technique with 3 rounds of the survey was used to develop the FAQ document to communicate privacy issues related to a generic secondary database study using the MiNDFIRL software. The Delphi panel consisted of 38 patients with chronic health conditions. We revised the FAQ between Delphi rounds and provided participants with a summary of the feedback. We adopted a conservative consensus threshold of less than 10% negative feedback per FAQ section. RESULTS: We developed a consensus language for 21 of the 24 FAQ sections. Participant feedback demonstrated preference differences (eg, brevity vs comprehensiveness). We adapted the final FAQ into an interactive web-based format that 94% (31/33) of the participants found helpful or very helpful. The template FAQ and MiNDFIRL source code are available on GitHub. The results indicate the following patient communication considerations: patients have diverse and varied preferences; the tone is important but challenging; and patients want information on security, identifiers, and final disposition of information. CONCLUSIONS: The findings of this study provide insights into what research-related information is useful to patients and how researchers can communicate such information. These findings align with the current understanding of health literacy and its challenges. Communication is essential to transparency and ethical data use, yet it is exceedingly challenging. Developing FAQ template language to accompany a complex software may enable researchers to provide greater transparency when informed consent is not possible.
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spelling pubmed-77720682021-01-07 Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study Schmit, Cason Ajayi, Kobi V Ferdinand, Alva O Giannouchos, Theodoros Ilangovan, Gurudev Nowell, W Benjamin Kum, Hye-Chung J Med Internet Res Original Paper BACKGROUND: There is substantial prior research on the perspectives of patients on the use of health information for research. Numerous communication barriers challenge transparency between researchers and data participants in secondary database research (eg, waiver of informed consent and knowledge gaps). Individual concerns and misconceptions challenge the trust in researchers among patients despite efforts to protect data. Technical software used to protect research data can further complicate the public's understanding of research. For example, MiNDFIRL (Minimum Necessary Disclosure For Interactive Record Linkage) is a prototype software that can be used to enhance the confidentiality of data sets by restricting disclosures of identifying information during the record linkage process. However, software, such as MiNDFIRL, which is used to protect data, must overcome the aforementioned communication barriers. One proposed solution is the creation of an interactive web-based frequently asked question (FAQ) template that can be adapted and used to communicate research issues to data subjects. OBJECTIVE: This study aims to improve communication with patients and transparency about how complex software, such as MiNDFIRL, is used to enhance privacy in secondary database studies to maintain the public's trust in researchers. METHODS: A Delphi technique with 3 rounds of the survey was used to develop the FAQ document to communicate privacy issues related to a generic secondary database study using the MiNDFIRL software. The Delphi panel consisted of 38 patients with chronic health conditions. We revised the FAQ between Delphi rounds and provided participants with a summary of the feedback. We adopted a conservative consensus threshold of less than 10% negative feedback per FAQ section. RESULTS: We developed a consensus language for 21 of the 24 FAQ sections. Participant feedback demonstrated preference differences (eg, brevity vs comprehensiveness). We adapted the final FAQ into an interactive web-based format that 94% (31/33) of the participants found helpful or very helpful. The template FAQ and MiNDFIRL source code are available on GitHub. The results indicate the following patient communication considerations: patients have diverse and varied preferences; the tone is important but challenging; and patients want information on security, identifiers, and final disposition of information. CONCLUSIONS: The findings of this study provide insights into what research-related information is useful to patients and how researchers can communicate such information. These findings align with the current understanding of health literacy and its challenges. Communication is essential to transparency and ethical data use, yet it is exceedingly challenging. Developing FAQ template language to accompany a complex software may enable researchers to provide greater transparency when informed consent is not possible. JMIR Publications 2020-12-15 /pmc/articles/PMC7772068/ /pubmed/33320097 http://dx.doi.org/10.2196/20783 Text en ©Cason Schmit, Kobi V Ajayi, Alva O Ferdinand, Theodoros Giannouchos, Gurudev Ilangovan, W Benjamin Nowell, Hye-Chung Kum. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.12.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Schmit, Cason
Ajayi, Kobi V
Ferdinand, Alva O
Giannouchos, Theodoros
Ilangovan, Gurudev
Nowell, W Benjamin
Kum, Hye-Chung
Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study
title Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study
title_full Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study
title_fullStr Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study
title_full_unstemmed Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study
title_short Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study
title_sort communicating with patients about software for enhancing privacy in secondary database research involving record linkage: delphi study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772068/
https://www.ncbi.nlm.nih.gov/pubmed/33320097
http://dx.doi.org/10.2196/20783
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