Interactive method of informing patients of the risks of intravenous contrast media.

Hopper, Kenneth D.; Zajdel, M; Hulse, S. F.; Yoanidis, N. R.; TenHave, Thomas R.; Labuski, Mark R.; Houts, Peter S.; Brensinger, C. M.; Hartman, David S.

doi:10.1148/radiology.192.1.8208968

Cited by 46 publications

(28 citation statements)

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“…29,50–63 The majority of these studies examined the use of audiovisual materials in addition to standard informed consent procedures. 29,50,54,55,57,58,62,63 Others evaluated audiovisual techniques in place of verbal or written information, 52,53,56,59–61 and 1 study evaluated the use of a video in addition to or in place of an informed consent discussion. 51 The content of audiovisual materials ranged widely, from a primary focus on risks of the procedure 52,56 to more comprehensive information about risks, benefits, alternatives, and general information about the procedure and recommended follow-up care.…”

Section: Resultsmentioning

confidence: 99%

“…60 Four studies evaluated interactive audiovisual programs that allowed patients to skip sections, request more information, self-pace, or test knowledge. 50,56,59,62 Noninteractive videos ranged in length from 5 min 53,58 to 16 min. 55 …”

Section: Resultsmentioning

confidence: 99%

“…Of the 15 studies evaluating audiovisual interventions, 11 showed improved comprehension 50,51,53,54,56–58,60–63 whereas 4 did not. 29,52,55,59 The degree of improved comprehension varied somewhat but was high overall (Table 2).…”

Section: Resultsmentioning

confidence: 99%

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Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

et al. 2010

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Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

et al. 2010

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“…25 These readability scores suggest that many patients lack real understanding, which leads to technically informed but uneducated consent. 26,27 There is a long history of concern about research conducted on impaired human subjects. 28 The competence of an impaired subject to provide consent is another issue that, with readability, is often neglected in the informed consent process.…”

Section: Introductionmentioning

confidence: 99%

The Use of Multimedia in the Informed Consent Process

Jimison

Sher

Appleyard

et al. 1998

Journal of the American Medical Informatics Association

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A b s t r a c t Objective:The goal of the project was to create recommendations and design specifications for a multimedia tool to enhance the informed consent process for clinical trials. The authors focused on the needs of patients with potential cognitive impairment. Design:The authors first performed a needs assessment using focus groups and interviews with health care researchers, institutional review board members, and three groups of patients (who had depression, breast cancer, or schizophrenia). Their feedback was incorporated into the design of a prototype multimedia tool. The design included general modules with information about clinical trials and informed consent as well as trial-specific modules. The authors then used the resulting prototype multimedia tool for informed consent in follow-up focus groups and interviews to obtain feedback on the feasibility and potential effectiveness of using such a tool routinely for clinical trials. Results:The authors showed that it was feasible to adapt a structured multimedia informed consent system to a specific clinical trial and to incorporate techniques to improve the understandability of informed consent content. Patients generally felt the prototype system was useful and could replace the paper document. They felt using the system would be less stressful, because they would have a greater sense of control and could proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable. Researchers and institutional review board members also found the system to be valuable in these ways but had concerns about how to review the system for potential biases in presentation and about the legal issues associated with replacing the paper document.Ⅲ JAMIA. 1998;5:245 -256. This paper explores the information needs of patients in the informed consent process for clinical research trials and how those needs might be met with the assistance of multimedia technology. Our objective was to use findings from the literature and feedback from patients and researchers to inform our recommendations for the design of a multimedia tool to enhance the informed consent process for clinical trials. We focused on the needs of patients with potential cognitive impairment. Our needs assessment included feedback from focus groups and interviews with patients who had depression, breast cancer, or schizophrenia, as well as interviews with health care researchers and institutional review board members.Consumers are demanding a greater choice and involvement at all levels of health care. In addition, the advancing sophistication of medical research necessitates a more sophisticated understanding of the process of informed consent in both clinical and research settings. With the increasing number of informed consent protocols being developed for new therapeutic trials, there is a clear need for improvements in informed consent.

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“…9 Now, interactive videos, which make it possible to select the explanation according to patient choice, have become available and are used in many medical settings. [13][14][15][16] Meanwhile, in Japan, there have been no cancer clinical trials using video for the informed consent process, except for this study. This is the first report in which a video was applied in a randomized controlled trial situation in Japan.…”

Section: Introductionmentioning

confidence: 99%

First use of a video to assist the informed consent process in a randomized controlled trial in Japan

Hamajima

1997

Int J Clin Oncol

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Background:In the United States, visual instruction using videos to describe health care services in general, and for acquiring informed consent in randomized controlled trials, is becoming routine. This paper reports the first use of video in a randomized trial in Japan. Methods:A video designed to describe treatment options to patients for prerandomization in a controlled trial for prostate cancer treatments was produced and distributed. Physicians participating in the trial were surveyed by questionnaire regarding the use of the video. Results:Of 47 eligible patients with prostate cancer enrolled in this trial between 1992 and 1994, 20 patients (43%) viewed the video and 27 patients (57%) received all information from the physician. The objective of this study was to determine if viewing the video influenced the patient's desire to express a choice between treatment options. After receiving the information, 11 of 20 patients (55%) who viewed the video, and 22 of 27 patients (81%) who did not view the video, expressed a preference. The difference in expression of a treatment preference between patients in each group was not significant. When the responses of all the patients in the trial are combined, 33 of 47 patients (70%) expressed a treatment preference. Conclusion:The benefits of providing information regarding treatment options in a video format, compared to other means of explanation, remains to be elucidated. However, videos may be a preferable method for acquiring informed consent from patients participating in randomized control trials.Int J Clin Oncol 1997;2:156-160

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Interactive method of informing patients of the risks of intravenous contrast media.

Abstract: This project demonstrates that a video format for informed consent before use of intravenous contrast material offers a good alternative to the written consent form.

Cited by 46 publications

References 0 publications

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

The Use of Multimedia in the Informed Consent Process

First use of a video to assist the informed consent process in a randomized controlled trial in Japan

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