Prospective Evaluation of Patient Comprehension of Informed Consent

Crepeau, Allison; McKinney, Bart; Fox-Ryvicker, Maya; Castelli, Jennifer; Penna, James; Wang, Edward D.

doi:10.2106/jbjs.j.01325

Cited by 71 publications

(54 citation statements)

References 4 publications

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“…In a prospective evaluation of patient comprehension of informed consent, Crepeau et al. found that surgical patient comprehension and recall immediately following a thorough discussion of the consent form was unexpectedly low . Previous investigations have examined the readability of consent forms use in research protocols as a contributing factor to poor comprehension .…”

Section: Introductionmentioning

confidence: 99%

“…3 In a prospective evaluation of patient comprehension of informed consent, Crepeau et al found that surgical patient comprehension and recall immediately following a thorough discussion of the consent form was unexpectedly low. 4 Previous investigations have examined the readability of consent forms use in research protocols as a contributing factor to poor comprehension. [5][6][7] These research protocol consent forms are substantially different from consent forms used in daily clinical practice, and to our knowledge, no study has evaluated the readability of invasive procedure consent forms used in daily practice.…”

Section: Introductionmentioning

confidence: 99%

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Readability of Invasive Procedure Consent Forms

Eltorai

Naqvi

Ghanian

et al. 2015

Clinical Translational Sci

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Background: Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. Materials and methods: To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Results: Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Conclusion: Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Readability of Invasive Procedure Consent Forms

Eltorai

Naqvi

Ghanian

et al. 2015

Clinical Translational Sci

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“…The level of recall of surgical complications was unrelated to sex; however, bettereducated patients were better at recalling the potential risks of an operation (11,15,18).…”

Section: Discussionmentioning

confidence: 99%

Healthy subjects’ knowledge of surgical complications: a hospital-based survey

Yalçın¹,

Dumlu²,

Tokaç³

et al. 2015

Turk J Med Sci

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Background/aim: There is an ongoing debate about how much a patient should know about serious or frequently occurring risks of their surgery. In this study, we evaluated healthy subjects' perspectives on knowledge of serious surgical complications.Materials and methods: Three hundred and thirty healthy subjects (151 women, 179 men; mean age: 43.6 ± 17.3 years) were surveyed with the study questionnaire. Social profile, surgical history of the healthy subjects, and presence of a relative while giving preoperative consent were assessed.Results: Only 23.5% (39/166) of the subjects were informed about all the potential complications of their previous surgical operation and 44.9% (73/166) did not get any preoperative consent on surgical complications. A statistically significant percentage of subjects who did not get proper information about the serious complications involved in their surgery indicated a desire for preoperative informed consent (97.0%, 128/132, P = 0.0001). Conclusion:The results indicated that a significant percentage of the subjects wanted to be informed of the potential complications of a surgery in the presence of a relative (73.9%, 192/260, P = 0.009). Involving a relative in preoperative consent may have a positive effect on the patient and can increase the level of postoperative recall of the risks.

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“…Nevertheless, studies of informed consent in clinical trials have that found some patients have limited understanding of the content presented during the consent process (Breese et al 2007; Crepeau et al 2011; Hill et al 2008; Joffe et al 2001). In response, researchers have proposed alternative methods, including cognitive interviewing techniques, visual aids, culturally appropriate resources, and attention to the oral presentation of the informed consent process’s key elements (Breese et al 2007; Yates et al 2009).…”

mentioning

confidence: 99%

Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

Chapman

Pevzner

Mangan

et al. 2015

AJOB Empirical Bioethics

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Background Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.

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Prospective Evaluation of Patient Comprehension of Informed Consent

Cited by 71 publications

References 4 publications

Readability of Invasive Procedure Consent Forms

Readability of Invasive Procedure Consent Forms

Healthy subjects’ knowledge of surgical complications: a hospital-based survey

Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

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