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      A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

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          Abstract

          Background

          Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process.

          Methods

          Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed.

          Results

          The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose.

          Conclusions

          IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.

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          Most cited references61

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          Clinical practice. Assessment of patients' competence to consent to treatment.

          Paul Appelbaum (2007)
          Article 0 comments Cited 181 times – based on 0 reviews     Review now
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            Readability standards for informed-consent forms as compared with actual readability.

            Michael Paasche-Orlow, Holly Taylor, Frederick Brancati (2003)
            Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight. To test these hypotheses, we conducted a cross-sectional study linking data from several public-use sources. A total of 114 Web sites of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form templates. Actual readability was measured with the Flesch-Kincaid scale, which assigns a score on the basis of the minimal grade level required to read and understand English text (range, 0 to 12). Data on the level of research activity, local literacy rates, and federal oversight were obtained from organizational Web sites. The average readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 10.8) on the Flesch-Kincaid scale. Specific readability standards, found on 61 Web sites (54 percent), ranged from a 5th-grade reading level to a 10th-grade reading level. The mean Flesch-Kincaid scores for the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (95 percent confidence interval, 2.4 to 3.2; P<0.001). Readability was not associated with either the level of research funding (P=0.89) or local rates of literacy (P=0.92). However, the 52 schools that had been made subject to oversight by the Office for Human Research Protections (46 percent) had lower Flesch-Kincaid scores than the other schools (10.2 vs. 10.9, P=0.005). IRBs commonly provide text for informed-consent forms that falls short of their own readability standards. Federal oversight is associated with better readability. Copyright 2003 Massachusetts Medical Society
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              Informed decision making in outpatient practice: time to get back to basics.

              C Braddock, K A Edwards, N Hasenberg … (2015)
              Many clinicians have called for an increased emphasis on the patient's role in clinical decision making. However, little is known about the extent to which physicians foster patient involvement in decision making, particularly in routine office practice. To characterize the nature and completeness of informed decision making in routine office visits of both primary care physicians and surgeons. Cross-sectional descriptive evaluation of audiotaped office visits during 1993. A total of 1057 encounters among 59 primary care physicians (general internists and family practitioners) and 65 general and orthopedic surgeons; 2 to 12 patients were recruited from each physician's community-based private office. Analysis of audiotaped patient-physician discussions for elements of informed decision making, using criteria that varied with the level of decision complexity: basic (eg, laboratory test), intermediate (eg, new medication), or complex (eg, procedure). Criteria for basic decisions included discussion of the nature of the decision and asking the patient to voice a preference; other categories had criteria that were progressively more stringent. The 1057 audiotaped encounters contained 3552 clinical decisions. Overall, 9.0% of decisions met our definition of completeness for informed decision making. Basic decisions were most often completely informed (17.2%), while no intermediate decisions were completely informed, and only 1 (0.5%) complex decision was completely informed. Among the elements of informed decision making, discussion of the nature of the intervention occurred most frequently (71 %) and assessment of patient understanding least frequently (1.5%). Informed decision making among this group of primary care physicians and surgeons was often incomplete. This deficit was present even when criteria for informed decision making were tailored to expect less extensive discussion for decisions of lower complexity. These findings signal the need for efforts to encourage informed decision making in clinical practice.
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                Author and article information

                Contributors
                : wleclercq@hotmail.com
                Journal
                Journal ID (nlm-ta): World J Surg
                Title: World Journal of Surgery
                Publisher: Springer-Verlag (New York )
                ISSN (Print): 0364-2313
                ISSN (Electronic): 1432-2323
                Publication date (Electronic): 7 April 2010
                Publication date PMC-release: 7 April 2010
                Publication date (Print): July 2010
                Volume: 34
                Issue: 7
                Pages: 1406-1415
                Affiliations
                [1 ]Department of General Surgery, Máxima Medical Centre, P.O. Box 7777, 5500 MB Veldhoven, The Netherlands
                [2 ]Department of Plastic and Reconstructive Surgery, University Medical Centre St Radboud, Nijmegen, The Netherlands
                [3 ]Department of Epidemiology and Biostatistics, University Medical Centre St Radboud, Nijmegen, The Netherlands
                Article
                Publisher ID: 542
                DOI: 10.1007/s00268-010-0542-0
                PMC ID: 2895877
                PubMed ID: 20372902
                SO-VID: 1e0ce2ee-12c4-4399-bcc4-3fbae9c5103d
                Copyright © © The Author(s) 2010
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                Subject: Article
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                issue-copyright-statement © Société Internationale de Chirurgie 2010

                ScienceOpen disciplines: Surgery
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                ScienceOpen disciplines: Surgery

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