Informed Consent

Goh, Hyun Gil; Shin, Sang Won

doi:10.1056/nejmc1704010

Cited by 7 publications

(7 citation statements)

References 9 publications

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“…Individual patient consent will be elicited from within the mobile app before collection of any demographic data in addition to using explicit Android permission requests. This approach of obtaining in-app informed consent is not uncommon in medical research; it has been described in detail in a previous systematic review [42] as well as specifically in mobile app–based research [43]. The results of this analysis will be shared with the Kenyan Ministry of Health, submitted to peer-review publications, and presented at international conferences.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Adaptive Feedback in a Smartphone-Based Serious Game on Health Care Providers’ Knowledge Gain in Neonatal Emergency Care: Protocol for a Randomized Controlled Trial

et al. 2019

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Background Although smartphone-based clinical training to support emergency care training is more affordable than traditional avenues of training, it is still in its infancy and remains poorly implemented. In addition, its current implementations tend to be invariant to the evolving learning needs of the intended users. In resource-limited settings, the use of such platforms coupled with serious-gaming approaches remain largely unexplored and underdeveloped, even though they offer promise in terms of addressing the health workforce skill imbalance and lack of training opportunities associated with the high neonatal mortality rates in these settings. Objective This randomized controlled study aims to assess the effectiveness of offering adaptive versus standard feedback through a smartphone-based serious game on health care providers’ knowledge gain on the management of a neonatal medical emergency. Methods The study is aimed at health care workers (physicians, nurses, and clinical officers) who provide bedside neonatal care in low-income settings. We will use data captured through an Android smartphone-based serious-game app that will be downloaded to personal phones belonging to the study participants. The intervention will be adaptive feedback provided within the app. The data captured will include the level of feedback provided to participants as they learn to use the mobile app, and performance data from attempts made during the assessment questions on interactive tasks participants perform as they progress through the app on emergency neonatal care delivery. The primary endpoint will be the first two complete rounds of learning within the app, from which the individuals’ “learning gains” and Morris G intervention effect size will be computed. To minimize bias, participants will be assigned to an experimental or a control group by a within-app random generator, and this process will be concealed to both the study participants and the investigators until the primary endpoint is reached. Results This project was funded in November 2016. It has been approved by the Central University Research Ethics Committee of the University of Oxford and the Scientific and Ethics Review Unit of the Kenya Medical Research Institute. Recruitment and data collection began from February 2019 and will continue up to July 31, 2019. As of July 18, 2019, we enrolled 541 participants, of whom 238 reached the primary endpoint, with a further 19 qualitative interviews conducted to support evaluation. Full analysis will be conducted once we reach the end of the study recruitment period. Conclusions This study will be used to explore the effectiveness of adaptive feedback in a smartphone-based serious game on health care providers in a low-income setting. This aspect of medical education is a largely unexplored topic in this context. In this randomized experiment, the risk of performance bias across arms is ...

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Section: Methodsmentioning

confidence: 99%

Evaluation of Adaptive Feedback in a Smartphone-Based Serious Game on Health Care Providers’ Knowledge Gain in Neonatal Emergency Care: Protocol for a Randomized Controlled Trial

et al. 2019

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“…Given the capacity of eIC processes such as interactive multimedia to standardize information delivery, use empirically validated methods of instruction, and enhance user engagement with the use of graphics, audio, video, pulldown menus, and other capabilities, eIC tools are widely expected to positively affect IC understanding (e.g., Grady, 2017;Shenoy, 2015). Wilbanks (2018, p. 110) comments that eIC "provides an opportunity to truly inform research participants about clinical protocols [to] provide a meaningful choice architecture to support a potential participant's decision making about whether or not to enroll.…”

Section: Electronic and Interactive Multimedia: An Effective Response?mentioning

confidence: 99%

Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes

Simon

Wang

Shinkunas

et al. 2021

Journal of Empirical Research on Human Research Ethics

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Some individuals’ understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.

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“…(33,(38)(39)(40) On the other hand, our data demonstrating safety of the intervention and weak signal for any variation in formal physical function assessments over time can inform a further, even more pragmatic iteration of our protocols. For example, modified verbal consent documented digitally-increasingly accepted in pragmatic clinical trials (41,42)-and mail delivery of the wearable activity tracker could decrease the burden of inperson study-related interactions and facilitate a focus on the exercise programming.…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

Group-Based Exercise in CKD Stage 3b to 4: A Randomized Clinical Trial

et al. 2021

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Informed Consent

Cited by 7 publications

References 9 publications

Evaluation of Adaptive Feedback in a Smartphone-Based Serious Game on Health Care Providers’ Knowledge Gain in Neonatal Emergency Care: Protocol for a Randomized Controlled Trial

Evaluation of Adaptive Feedback in a Smartphone-Based Serious Game on Health Care Providers’ Knowledge Gain in Neonatal Emergency Care: Protocol for a Randomized Controlled Trial

Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes

Group-Based Exercise in CKD Stage 3b to 4: A Randomized Clinical Trial

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