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Editorial |

Informing Patient Choice and Consent: Title and subTitle BreakWhat Patients Really Want and Need to Know

Alan R. Morse, JD, PhD
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Copyright 2010 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

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Arch Ophthalmol. 2010;128(1):129-130. doi:10.1001/archophthalmol.2009.335
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Patients may not be aware of all they need to know to make informed decisions about their care. Treatments have risks and alternatives that vary by patient, procedure, treatment, and, of immediate interest, by physician. While this may seem axiomatic, physician-specific data are frequently omitted, though federal regulations are clear that this information is relevant, and encourage disclosure.1 Patients may choose their physician but not the residents who are generally assigned to cases based on teaching and training needs. Is it relevant for patients to know that their surgeons are in training? Of course.

Surgical skills improve with experience beyond the number of procedures required by residency training programs.2 3 This has been well documented for cataract surgery in which surgical efficiency increases while complications decrease beyond the 86 procedures residents are required to complete as primary surgeons under the Accreditation Council for Graduate Medical Education Residency Review Committee standards.4 The expectation is that all residents will ultimately master the required procedures and techniques but the existence of a surgical learning curve has obvious implications for what constitutes appropriate disclosure as part of the informed consent process.

Historically, there has been reluctance to disclose training status to patients, most likely out of concern that patients might reject their participation. For example, Nguyen and colleagues5 asked all 20 ophthalmologists in 2 departments of ophthalmology if they would agree to use a standardized form for their patients who were having cataract surgery that disclosed when a resident would be involved in the surgery: only 5 agreed, with 4 of them indicating that they routinely do not discuss such matters with patients. The 15 nonparticipating physicians cited reasons including raising the patient's anxiety level, the possibility of losing patients, and concern about the extra time it would take to explain this properly to their patients for their unwillingness to participate. Of 49 patients having cataract surgery, only 8 (16%) agreed to have a resident involved in their surgery. In contrast, in surveying the attitudes and beliefs of 106 patients with cataracts, Wisner et al6 found that 78% indicated that they were likely or very likely to permit residents to assist if asked prior to their cataract surgery while 51% would actually allow the resident to perform the surgery. While some indicated that the level of resident experience would affect their decision, only patients with a previous negative experience with residents declined resident involvement. Wisner et al concluded, “Full disclosure of level of resident involvement in cataract surgery likely would not adversely affect resident surgical training or attending surgeon volume.”6 (p1239)

One difference between the Nguyen et al and Wisner et al studies is their underlying attitude and approach: Nguyen and colleague's study asked surgeons what they do about resident involvement and whether they would be willing to use a standardized disclosure form to change their current practices. On the other hand, Wisner et al approached the resident training issue head-on. Ophthalmologists at ethics rounds discussed resident involvement with cataract surgery, highlighting the importance of patient understanding and consent, which undoubtedly affected the attitudes of ophthalmology department staff. Following staff in involvement in ethics rounds, patients who participated were queried in detail about resident involvement in surgery and the need for discussion and disclosure prior to surgery. The difference between these 2 studies, one questioning surgeons about their practice and the other questioning patients about their expectations, helps explain the difference in their outcomes; the more physicians understand ethical issues and the more open and direct their patient communications, the more likely the patients are to permit resident involvement.

How then should patients be advised that a resident might be involved in their care? The burden is on the treating physician. Properly obtaining patient consent for resident participation should include the following disclosures, all of which should be well documented:

  • Whether the patient will permit resident physician participation and the part(s) of a procedure in which they may participate

  • If the resident who will participate is known, the information for that specific resident, by name, should be included in the disclosure

  • When the name of a specific resident is unknown at the time of informed choice process, this too should be disclosed, and the patient may indicate their agreement to allow a resident with a certain level of experience to participate

  • In all cases patients can choose freely whether to permit resident participation in their surgery.

Informed choice requires discussion of information that a reasonable patient might find significant in making a treatment decision. What might a reasonable patient expect? “Essentially, the physician must explain the rationale for the treatment, significant benefits, risks, and reasonable alternatives to the treatment proposed in language that the patient can understand.”7 Providing too much information in too technical a manner may be confusing, while too little information may be equally obfuscating. Adequate disclosure to enable patient choice and inform the consent process requires at least 6 elements:

  • The prognosis without treatment, ie, what will happen if nothing is done?

  • Whether there are viable treatment alternatives; if so, what are their consequences as well as their success and failure rates?

  • Why the suggested course of treatment is preferable

  • The risks and the likelihood of adverse outcomes, including minor events likely to occur and major events, however unlikely

  • The possibility of unknown events and the course of treatment that would then be required, repeating each of the above elements in the disclosure

  • Any physician-specific information that might influence patient choice or affect outcome.

While some may see a conundrum in balancing a patient's right to information against a resident's training needs, there really is no dilemma; patients' rights always prevail. Disclosures designed to give patients the information they need to make informed choices must include physician-specific factors; this is especially relevant when the physician is in training. A patient can reasonably rely on professional credentials such as board certification to establish standards of professional competence, but with resident physicians, such information is not available. Moreover, consent forms may lack physician-specific information because they often are completed shortly before procedures when the composition of the entire treatment team may not be known because it is often dependent on which resident(s) are available at the time of surgery.

Patients have the right to make their health care choices and the “more intense and personal the consequences of a choice and the less direct or significant the impact of that choice upon others, the more compelling the claim to autonomy in the making of a given decision.”8 It is inevitable that many of their choices will be different from those of their physicians, but patients have the right to make decisions about their own care, even if objectively wrong. As Justice Cardozo pronounced almost a century ago, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”9 The foundation of informed choice is trust between patient and physician and requires that all relevant information be provided to patients in an intelligible form. The burden of determining whether a patient is making an informed choice rests with the treating physician. It is essential that the treating physician understand what the patient understands as well as the process that led to that understanding. Patients should indicate their approval of each significant element of disclosure to make certain that they truly understand the information and are not overwhelmed and merely assenting to a choice made by the physician.10 Patients rely on physicians to provide information about diagnosis and treatment alternatives, while physicians trust that their patients will candidly divulge information that could foreseeably affect the treatment process and outcome. While the choice of treatment is the patient’s, physicians have a duty to ensure that the patient's decision is fully informed.

AUTHOR INFORMATION

Correspondence: Dr Morse, The Jewish Guild for the Blind, 15 W 65th St, New York, NY 10023 (armorse@jgb.org).

Financial Disclosure: None reported.

 State operations manual appendix A: survey protocol, regulations and interpretive guidelines for hospitals. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/manuals/Downloads/som107ap_a_hospitals.pdfAccessed March 1, 2009
Randleman  JB, Wolfe  JD, Woodward  M, Lynn  MJ, Cherwek  DH, Srivastava  S. The resident surgeon phacoemulsification learning curve. Arch Ophthalmol 2007;125 (9) 1215- 1219
PubMed
Corey  RP, Olson  RJ. Surgical outcomes of cataract extractions performed by residents using phacoemulsification. J Cataract Refract Surg 1998;24 (1) 66- 72
PubMed
 Ophthalmology resident operative minimum requirements. Accreditation Council for Graduate Medical Education Web site. http://www.acgme.org/acWebsite/RRC_240/240_MinimumsOperativeTable.pdfAccessed June 12, 2009
Nguyen  TN, Silver  D, Arthurs  B. Consent to cataract surgery performed by residents. Can J Ophthalmol 2005;40 (1) 34- 37
PubMed
Wisner  DM, Quillen  DA, Benderson  DM, Green  MJ. Patient attitudes toward resident involvement in cataract surgery. Arch Ophthalmol 2008;126 (9) 1235- 1239
PubMed
 Advisory opinion of the code of ethics: informed consent. American Academy of Ophthalmology Web site. http://www.aao.org/about/ethics/upload/Informed-Consent-2008.pdfAccessed May 10, 2009
Shultz  MM. From informed consent to patient choice: a new protected interest. Yale Law J 1985;95 (2) 219- 299
PubMed
Schloendorff v Society of New York Hospital 211 NY 125, 105 NE 92 (1914)
O’Neill  O. Some limits of informed consent. J Med Ethics 2003;29 (1) 4- 7
PubMed

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 State operations manual appendix A: survey protocol, regulations and interpretive guidelines for hospitals. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/manuals/Downloads/som107ap_a_hospitals.pdfAccessed March 1, 2009
Randleman  JB, Wolfe  JD, Woodward  M, Lynn  MJ, Cherwek  DH, Srivastava  S. The resident surgeon phacoemulsification learning curve. Arch Ophthalmol 2007;125 (9) 1215- 1219
PubMed
Corey  RP, Olson  RJ. Surgical outcomes of cataract extractions performed by residents using phacoemulsification. J Cataract Refract Surg 1998;24 (1) 66- 72
PubMed
 Ophthalmology resident operative minimum requirements. Accreditation Council for Graduate Medical Education Web site. http://www.acgme.org/acWebsite/RRC_240/240_MinimumsOperativeTable.pdfAccessed June 12, 2009
Nguyen  TN, Silver  D, Arthurs  B. Consent to cataract surgery performed by residents. Can J Ophthalmol 2005;40 (1) 34- 37
PubMed
Wisner  DM, Quillen  DA, Benderson  DM, Green  MJ. Patient attitudes toward resident involvement in cataract surgery. Arch Ophthalmol 2008;126 (9) 1235- 1239
PubMed
 Advisory opinion of the code of ethics: informed consent. American Academy of Ophthalmology Web site. http://www.aao.org/about/ethics/upload/Informed-Consent-2008.pdfAccessed May 10, 2009
Shultz  MM. From informed consent to patient choice: a new protected interest. Yale Law J 1985;95 (2) 219- 299
PubMed
Schloendorff v Society of New York Hospital 211 NY 125, 105 NE 92 (1914)
O’Neill  O. Some limits of informed consent. J Med Ethics 2003;29 (1) 4- 7
PubMed

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