Informed consent: how much and what do patients understand?

Falagas, Matthew E.; Korbila, Ioanna; Giannopoulou, K.; Kondilis, Barbara; Peppas, George

doi:10.1016/j.amjsurg.2009.02.010

Cited by 333 publications

(268 citation statements)

References 64 publications

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“…[1][2] However, the level of understanding that patients have of their planned surgery and its associated complications has often been underestimated. [3][4] Conventional techniques of delivering education to patients through verbal, illustrative and leaflet-based instructions may not be effective enough to adequately explain the surgical procedure and potential postoperative complications. The low efficiency of these methods in delivering the required information may be attributed to the educational and the cultural barriers between the patients and the clinicians.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of three-dimensional visualization in mobile apps for patient education regarding orthognathic surgery

Pulijala

Ju³

et al. 2016

International Journal of Oral and Maxillofacial Surgery

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Abstract'Sur-face', is an interactive mobile app illustrating different orthognathic surgeries and their potential complications. This study aimed to evaluate the efficacy of Sur-face by comparing two methods of delivering patients' information regarding orthognathic surgeries and their related potential complications: a mobile app with interactive 3D animations and a voice recording containing verbal instructions only. For each method, the participants' acquired knowledge was assessed using a custom designed questionnaire. Participants of the 'app' group performed significantly better (p<0.0034) than the 'voice' group and retained more knowledge, suggesting that interactive visualizations play a key role in improving the understanding of the orthognathic surgical procedure and its associated complications. This study emphasizes the impact of 3D visualizations in delivering information regarding orthognathic surgery and highlights the advantage of delivering validated patient information through mobile apps.

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Section: Introductionmentioning

confidence: 99%

Efficacy of three-dimensional visualization in mobile apps for patient education regarding orthognathic surgery

Pulijala

Ju³

et al. 2016

International Journal of Oral and Maxillofacial Surgery

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“…Thus, the need for participants to understand and "buy in" to the concept of the trial is arguably paramount. There is a wealth of evidence to suggest that comprehension can pose a barrier to clinical trial participation and recruitment [29][30][31][32][33][34]. Our findings suggest this is also relevant in a remote trial where the relationship between the intervention and the devices used to support the intervention, have the potential to be unclear.…”

Section: Principal Findingsmentioning

confidence: 74%

The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study (Preprint)

Donnelly¹,

Reginatto²,

Kearns³

et al. 2017

Preprint

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BACKGROUND Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. OBJECTIVE The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. METHODS Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities co-ordinator, and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. RESULTS Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. CONCLUSIONS A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.

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“…(10,11) As a solution to such a problem, visual aids, as well as multimedia tools, have recently been tried as tools for informed consent. (8) In previous studies, Sahai et al reported that the degree of patient satisfaction was relatively higher following video assisted information for endoscopic surgery. (12) In Cowan et al, the degree of patient understanding was found to be relatively higher in the group where a video-assisted informed consent was made as compared with that where a verbal informed consent was made (71.0% vs. 54.3%).…”

Section: Discussionmentioning

confidence: 99%

“…(5,6) To add to that, there is an increasing demand for precise and comprehensive information regarding diagnostic tests and procedures, caused by a different perception towards medical services by consumers. (7,8) However, due to overcrowding and the fact that emergency physicians are understaffed, sufficient time to thoroughly explain the procedure is not available, making the process rather perfunctory. (9,10) As emergency departments becomes overloaded, the need for thorough explanation regarding invasive procedures and diagnostic tools is increasing.…”

Section: Discussionmentioning

confidence: 99%

Informed Consent for Intravenous Contrast Administration in the Emergency Department: Understanding and satisfaction among patients using the video-assisted vs. traditional methods

2017

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Background. Computed-tomography (CT) is increasingly performed among patients who visit an emergency department (ED), many of whom require the administration of intravenous contrast, to make an accurate diagnosis of their condition and offer prompt treatment. Though the safety profile of new intravenous contrast agents has improved, patients are still exposed to significant risk from potentially life-threatening reactions. Materials and Methods. This is a prospective study. Subjects were patients over the age of 18, or their family representative, who visited the ED. Subjects were randomly assigned to either the original routine explanation for consent or the videoassisted explanation. Patients completed a questionnaire about contrast adverse effects and the proposed treatment. Results. Mean values of the degree of understanding of informed consent were relatively higher in the video-assisted group. When assessing the proficiency of the informer, the score for understanding and satisfaction was higher in the attending staff informed group than the house staff informed group. Conclusion. This study showed a higher level of understanding in the group that was provided information using visual aids, rather than in the traditional way. Also, a higher level of understanding and satisfaction was shown among those who

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Informed consent: how much and what do patients understand?

Cited by 333 publications

References 64 publications

Efficacy of three-dimensional visualization in mobile apps for patient education regarding orthognathic surgery

Efficacy of three-dimensional visualization in mobile apps for patient education regarding orthognathic surgery

The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study (Preprint)

Informed Consent for Intravenous Contrast Administration in the Emergency Department: Understanding and satisfaction among patients using the video-assisted vs. traditional methods

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