Sources of patient uncertainty when reviewing medical disclosure and consent documentation

Donovan-Kicken, Erin; Mackert, Michael; Guinn, Trey; Tollison, Andrew C.; Breckinridge, Barbara

doi:10.1016/j.pec.2012.10.007

Cited by 23 publications

(20 citation statements)

References 18 publications

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“…Language is an evident communication barrier in CALD groups [ 6 ]. Communication barriers also include issues associated with complex forms and informed consent procedures [ 38 , 39 ], which are amplified for people with limited English language and/or low literacy [ 28 ]. Achieving true informed consent, even amongst those for whom English is a first language, can be difficult [ 28 , 39 , 40 ].…”

Section: Resultsmentioning

confidence: 99%

“…Communication barriers also include issues associated with complex forms and informed consent procedures [ 38 , 39 ], which are amplified for people with limited English language and/or low literacy [ 28 ]. Achieving true informed consent, even amongst those for whom English is a first language, can be difficult [ 28 , 39 , 40 ]. Much debate has occurred on the comprehensibility of participant information forms, which are often notoriously lengthy and require a high (often tertiary) level of reading comprehension [ 17 , 41 – 43 ].…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials

Hughson

Woodward‐Kron

Parker

et al. 2016

Trials

105

111

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The under-representation of culturally and linguistically diverse participants in clinical trials is an ongoing concern for medical researchers and the community. The aim of this review is to examine the complex issue of recruiting culturally and linguistically diverse (CALD) older people to medical research and to examine responses to these issues. The review focuses on (1) trends in the existing literature on barriers to and strategies for recruiting CALD and older people to clinical research, (2) issues with informed consent for CALD populations, and (3) the efficacy of innovative approaches, including approaches incorporating multimedia in research and consent processes. The literature indicates that predominant barriers to greater involvement of CALD patients in clinical trials are communication, including literacy and health literacy considerations; English language competence; and cultural factors in the research setting such as mistrust of consent processes, as well as considerable practical and logistical barriers, including mobility considerations. Some evidence exists that incorporating multimedia resources into the informed consent process can improve patient understanding and is preferred by patients, yet these findings are inconclusive. A multi-methodological approach, including the use of culturally and linguistically sensitive multimedia tools, may help address the issue of low inclusion of CALD groups in clinical research. Researcher education needs to be taken into account to address preconceptions about CALD resistance to research participation and to raise awareness of cultural concerns in regard to research participation.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials

Hughson

Woodward‐Kron

Parker

et al. 2016

Trials

105

111

View full text Add to dashboard Cite

show abstract

“…Hamnes et al find that consent documents in rheumatological studies are not sufficiently readable for the majority of the population [15], a finding which is supported by Vučemilo and Borovečki who also find that medical consent forms often exclude important information [53]. Donovan-Kicken et al examine the sources of confusion when reviewing such documents [8], which include insufficient discussion of risk and lengthy or overly complex language. Munteanu et al examine the ethics approval process in a number of HCI research case studies, finding that participants often agreed to consent instruments they have not read or understood, and the rigidity of such processes can often be at odds with such studies where a "situational interpretation" of an agreed protocol is needed [36].…”

Section: Introductionmentioning

confidence: 99%

Beyond the EULA: Improving Consent for Data Mining

Hutton

Henderson

2017

Studies in Big Data

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Companies and academic researchers may collect, process, and distribute large quantities of personal data without the explicit knowledge or consent of the individuals to whom the data pertains. Existing forms of consent often fail to be appropriately readable and ethical oversight of data mining may not be sufficient. This raises the question of whether existing consent instruments are sufficient, logistically feasible, or even necessary, for data mining. In this chapter, we review the data collection and mining landscape, including commercial and academic activities, and the relevant data protection concerns, to determine the types of consent instruments used. Using three case studies, we use the new paradigm of human-data interaction to examine whether these existing approaches are appropriate. We then introduce an approach to consent that has been empirically demonstrated to improve on the state of the art and deliver meaningful consent. Finally, we propose some best practices for data collectors to ensure their data mining activities do not violate the expectations of the people to whom the data relate.

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“…24,26 Clinicians' concerns about CALD patients with limited English proficiency struggling to understand trials are not unreasonable given that many English-speaking patients find trial information difficult to comprehend. 27,28 Data regarding the use of interpreters or bilingual family members to explain trials was unavailable in this instance, but may be worth examining in future studies, along with levels of understanding among both interpreters and patients.…”

Section: Barriers To Trial Participationmentioning

confidence: 98%

“…31 It is important that strategies to overcome barriers to comprehension of trial information amongst patients generally, such as using simple language and clear formatting, are employed before materials are translated. 27 Innovative approaches to explaining trials, such as using multimedia (e.g. audio and pictures/videos) delivered via electronic devices may help overcome literacy issues and have been found to greatly increase comprehension and retention of information.…”

Section: Strategies To Improve Cald Patient Trial Participationmentioning

confidence: 99%

Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers

Smith

Agar

Delaney

et al. 2017

Asia-Pac J Clncl Oncology

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Aim: Clinical trials play a critical role in advancing cancer care, but international research shows that few cancer patients, particularly culturally and linguistically diverse (CALD) patients, participate in trials. This limits generalizability of trial results and increases health disparities. This study aimed to establish rates and correlates of trial participation among CALD patients in South Western Sydney Local Health District (SWSLHD), a highly culturally diverse area. Conclusions: Limited English proficiency seems particularly unfavorable to trial participation.Development and evaluation of strategies to overcome language barriers (e.g. simplified and translated multimedia participant information materials) is needed.

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Sources of patient uncertainty when reviewing medical disclosure and consent documentation

Cited by 23 publications

References 18 publications

A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials

A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials

Beyond the EULA: Improving Consent for Data Mining

Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers

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