EDITORIAL

Consent: Can it be more informed? Siao et al, the authors of the article “Assessment of Delivery Methods Used in the Informed Consent Process in a Safety Net Hospital,”1 are to be congratulated for taking on the task of improving informed consent, particularly for vulnerable, low health literacy, or “safety net” populations. The hard work and time invested in document translation and the targeted nurse practitioner-run educational groups have borne fruit as documented by statistical results and analysis presented. Before looking at some of the broader issues implied in efforts to improve informed consent, some of the weaknesses of this study should be noted. First, the populations studied were different, in that a healthier open-access group (tested positive on the fecal immunochemical test, personal history of polyps, family history of colon cancer, iron deficiency) were compared with a clinic group, where, as the authors noted, illness and worry may have impaired the patient’s focus on (and memory of) the disease discussion rather than the consent discussion. Next, the study group had dedicated and defined time for the nurse-led consent process, whereas the clinic patients presumably had to fit consent into the time for the whole visit (which also may have been slowed by translation needs and low health literacy). The amount of time for the consent process in clinic patients was not specified, but because the nurse practitioner-run group had scheduled dedicated time and a preset PowerPoint presentation (Microsoft, Redmond, WA, USA), one may speculate that if the study group had more time for the consent process, they would thus more likely absorb more information. Further, the study group had a preplanned PowerPoint slide presentation that covered the questions tested in the survey. Thus, perhaps the study group could have been expected to do better. However, one can argue that is precisely why, because informed decision making is an ethical and legal imperative, that perhaps dedicated time and structure, at least for frequently performed procedures, are necessary. On the other hand, in this era of cost containment, where will the time and funding come from? Were the gains in informed understanding both clinically significant and sufficient to justify the additional cost? For instance, although the study group did dramatically better on some of the elements of the consent tests, for

Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.03.016

www.giejournal.org

many other elements, the scores were about a 10% to 12% improvement for the study group, and any of the “satisfaction with consent” scores were about the same. Nevertheless, the study group clearly did better, and we know they had the appropriate information presented. Finally, because informed consent is important and is an ethical and legal mandate, what are the best and most costeffective ways to deliver it?2 This is not necessarily a onesize-fits-all issue. As the authors noted in their discussion, a variety of methods have been proposed, from pamphlets to multimedia to computer based to present and test strategies. Perhaps for a safety net population with language barriers, a dedicated clinic will prove bestdand even off-

Because informed consent is important and is an ethical and legal mandate, what are the best and most cost-effective ways to deliver it? This is not necessarily a one-size-fits-all issue.

load the clinicians with ill patients in clinic. On the other hand, for educated, computer-savvy patients, especially those with work-related time constraints, Web-based or mailed informational packets that can be reviewed and rereviewed at a convenient time of the patient’s choosing may allow better understanding of the elements of consent. Here are 2 risk management tips: consent in many states is a nondelegable duty. The performing physician must at least complete the consent process. However, a patient who is well informed before the time of the procedure will likely need only a very brief discussion with the proceduralist.3 Second, should a consent issue arise in litigation, the materials used for the consent (whether PowerPoint slides, mailed, or Web-based informational materials) could likely be introduced in court and avoid the “he said/ she said; didn’t have my glasses” difficulty where patients frequently do not recall elements of the consent discussion even when it did occur. In fact, Washington state allows vetted decision aids to be introduced as an affirmative defense that an adequate consent was provided. Finally, how will improvements in informed consent be accomplished? Should we wait for well-meaning and experienced clinicians like the San Francisco group to decide to pursue consent improvements? Consent materials Volume 80, No. 1 : 2014 GASTROINTESTINAL ENDOSCOPY 69

Editorial

D. Feld

not only need to be developed, but may be thought to be more reliable with widespread agreement and need to be updated periodically to ensure continued accuracy. Is it time for the GI societies to develop or enhance ongoing consent committees that may tackle procedures, high-risk medications, and situations and go beyond our small pamphlets and put together detailed consent consensus materials and processes, with periodic consensus updates? This could carry on the good work of the San Francisco group and the many academic and private GI groups that have developed their own materials or programs even further. This could be a help to our patients and membership and could advance our ethical and legal goals. It would also allow consensus and improvements in the informed consent process for multiple other common consent issues: high risk medications, difficult clinical decisions with common themes, and perhaps genetic and other screening issues.4 DISCLOSURE The author disclosed no financial relationships relevant to this article.

Andrew D. Feld, MD, JD Service Line Chief, Gastroenterology Group Health Cooperative Seattle, Washington, USA University of Washington Seattle, Washington, USA

REFERENCES 1. Siao D, Sewell JL, Day LW. Assessment of delivery methods used in the informed consent process at a safety-net hospital. Gastrointest Endosc 2014;80:61-8. 2. Berg JW, Appelbaum PS, Lidz CW. Informed consent: legal theory and clinical practice. Oxford (UK): Oxford University Press; 2001. 3. Feld AD. Informed consent for colonoscopy. In: Waye JD, Rex DK, Williams CB, editors. Colonoscopy principles and practice. London, UK: Blackwell Publishing; 2010. 4. Feld AD. Informed consent: not just for procedures anymore. Am J Gastroenterol 2004;99:977-80.

Endoscopedia GIE now has a blog! Keep up with GIE news by following us at www.endoscopedia.com.

70 GASTROINTESTINAL ENDOSCOPY Volume 80, No. 1 : 2014

www.giejournal.org

Consent: Can it be more informed?

Consent: Can it be more informed? - PDF Download Free
81KB Sizes 1 Downloads 4 Views