iPad-Based Patient Briefing for Radiological Examinations—a Clinical Trial

Schlechtweg, Philipp; Hammon, Matthias; Giese, David; Heberlein, Christian; Uder, Michael; Schwab, Siegfried A.

doi:10.1007/s10278-014-9688-x

Cited by 17 publications

(13 citation statements)

References 12 publications

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“…In individual studies on consent procedures where the only difference was the medium used, patients generally preferred electronic over paper-based questionnaires in spite of the fact that the former took longer to complete [ 81 , 82 ], perhaps because they had to be filled out completely in order for patients to finish them (which is in itself advantageous from a researcher perspective).…”

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

110

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%

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

Hughson

Woodward‐Kron

Parker

et al. 2016

Trials

110

111

View full text Add to dashboard Cite

show abstract

“…Although the performance of digital patient briefing prior to MRI examinations has been evaluated in various studies [4,5], no corresponding data regarding digital patient briefing prior to CT examinations has been published to date. In our opinion a decisive difference compared to MRI is the higher rate of CT examinations due to the typically shorter examination time.…”

Section: Discussionmentioning

confidence: 99%

Initial Experience with Digital Patient Briefing in Computed Tomography

Alikhani

Hensen

Febrero

et al. 2018

Fortschr Röntgenstr

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Purpose To assess digital patient briefing as an alternative to conventional paper documentation. Materials and Methods 502 patients with a planned computed tomography (CT) examination were selected for digital patient briefing using the E-ConsentPro software from Thieme Compliance on an iPad by Apple (Cupertino, California, USA). For the analysis, three age groups were formed. The time required for the patient briefing, the number of open questions as well as the time needed for discussion with physicians were determined. Student’s t-test was performed to assess statistical significance. Results There was no significant difference between patient age and briefing time which was about 20 minutes on average. The number of open or unclear questions increased with patient age. While patients younger than 30 years of age had about 2 open questions, patients over 30 and 60 years had about 4 and 5 questions, respectively. The total time needed for discussion with physicians was less than 2 minutes on average. A significant difference in the time required for discussion with physicians could not be observed between the individual age groups. Conclusion Tablet-based digital briefing allows the storage of patient documents with reasonable time and effort. Furthermore, it minimizes the risk of data loss. Key Points Citation Format

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“…In a study to compare iPad to standard paper briefings for radiological examinations, Schlechtweg et al (2014) noted a positive correlation between the duration of electronic briefing and patient age and a negative correlation between computer skills and patient age 12 . In our study, no significant differences in patient demographics were detected among study groups, including age.…”

Section: Discussionmentioning

confidence: 99%

Research Electronic Data Capture (REDCap) electronic Informed Consent Form (eICF) is compliant and feasible in a clinical research setting

2015

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Background: Electronic consent for research has shown success in clinical trial models, but has not been rigorously evaluated as an alternative to conventional paper consent. We sought to design a 21 CFR Part 11 compliant iPad-based electronic Informed Consent Form (eICF) with Research Electronic Data Capture (REDCap). As a secondary aim, we sought to compare subject workload between eICF and paper consent groups.Methods: This is a prospective, randomized study of subjects who completed an iPad-based eICF versus paper consent for research. The eICF was designed with REDCap and presented on an iPad. Subject workload was measured with the NASA Task Load Index (NASA-TLX) and subjective feedback in regards to consent process was collected.Results: A total of 116 subjects were screened for consent. Of which, 51 (44%) subjects provided informed consent and completed all study related procedures. Twenty-five (49%) eICF and 26 (51%) paper consents were completed. The eICF group rated a significantly greater preference to use the eICF for future research studies (6.4±1.5) compared to the paper consent group (5.0±1.9), p<0.01. There were no significant differences in NASA-TLX Weighted Scale or Total-TLX Scores between groups. One error resulted in the eICF group due to an inadvertent submission by a single subject.Conclusion: In summary, we have demonstrated that an iPad-based eICF designed with REDCap is both 21 CFR Part 11 compliant and feasible in the clinical research setting. The eICF does not appear to be more technically difficult or demanding than conventional paper consent.

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iPad-Based Patient Briefing for Radiological Examinations—a Clinical Trial

Cited by 17 publications

References 12 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

Initial Experience with Digital Patient Briefing in Computed Tomography

Research Electronic Data Capture (REDCap) electronic Informed Consent Form (eICF) is compliant and feasible in a clinical research setting

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