Hostname: page-component-77c89778f8-cnmwb Total loading time: 0 Render date: 2024-07-17T22:06:05.233Z Has data issue: false hasContentIssue false
  • English
  • Français

Consent Forms, Readability, and Comprehension: The Need for New Assessment Tools

Published online by Cambridge University Press:  28 April 2021

Wendy K. Mariner  and
Patricia A. McArdle
Get access Rights & Permissions [Opens in a new window]

Extract

Recent efforts to evaluate the effectiveness of the informed consent process between physician and patient have focused on the ability of patients to understand written “informed consent” documents. Several researchers, employing traditional readability formulas to measure the reading level of such documents, have noted that many of these forms are written at a level too difficult for most people to understand. Readability formulas, such as those of Flesch and Fry, and the SMOG formula, have become convenient measures of the effectiveness of informed consent documents in conveying information to patients to enable them to make decisions about recommended therapies.

Our experience, in a pilot study, with readability formulas to test an informed consent document used in childhood poliomyelitis immunizations led us to conclude that readability formulas are an inadequate measure of patients’ comprehension of written information about medical procedures.

Type
Article
Information
Law, Medicine and Healthcare , Volume 13 , Issue 2 , April 1985 , pp. 68 - 74
Copyright
Copyright © American Society of Law, Medicine and Ethics 1985

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Bergler, J. H., Informed Consent: How Much Does the Patient Understand? Clinical Pharmacology and Therapy 27(4): 435 (April 1980); Cassileth, B.R., Informed Consent: Why Are Its Goals Imperfectly Realized? New England Journal of Medicine 302(16): 896–900 (April 17, 1980); Howard, J. M., DeMets, D., How Informed is Informed Consent? The BHAT Experience, Controlled Clinical Trials 2: 287–303 (1981); Kennedy, B. J., Lillehaugen, A., Patient Recall of Informed Consent, Medical and Pediatric Oncology 7: 173–78 (1979); Muss, H.B., Written Informed Consent in Patients with Breast Cancer, Cancer 43(4): 1549–56 (April 1979); Riecken, H.W., Ravitch, R., Informed Consent to Biomedical Research in Veterans Administration Hospitals, Journal of the American Medical Association 248(3): 344–48 (July 16, 1982).Google ScholarPubMed
Grundner, T.M., On the Readability of Surgical Consent Forms, New England Journal of Medicine 302(16): 900–02 (April 17, 1980); Doak, L.G. Doak, C.C., Patient Comprehension Profiles: Recent Findings and Strategies, Patient Counseling and Health Education, pp. 101–06 (1980).Google ScholarPubMed
Flesch, R.. The Art of Readable Writing (Harper & Row, New York, N.Y.) (1976).Google Scholar
Fry, E. A., A Readability Formula that Saves Time, Journal of Reading 11: 512–16, 575–78 (1968).Google Scholar
McLaughlin, G. H., SMOG Grading—A New Readability Formula, Journal of Reading 12: 639–46 (1969).Google Scholar
Public Health Service, U.S. Dept, of Health&Human Services, Important Information about Polio and Polio Vaccine (1979).Google Scholar
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions: Volume One: Report (U.S. Gov't Printing Ofc., Washington D.C.) (1983) at 44–51; Meisel, A., The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent, Nebraska Law Review 56(1): 51–152 (1977). See, e.g., Schloendorff v. Society of New York Hosp., 105 N.E. 92, 98 (N.Y. 1914) (every human being of adult years and sound mind has a right to determine what shall be done with his own body).Google Scholar
E.g., Salgo v. Board of Trustees of Leland Stanford Jr. Univ., 317 P.2d 170, 181 (Cal. App. 1957).Google Scholar
See, e.g., Natanson v. Kline, 354 P.2d 670, 673 (Kan. 1960).Google Scholar
Canterbury v. Spence, 464 F.2d 772, 786-87 (D.C. Cir. 1972); Cobbs v. Grant, 502 P.2d 1, 11 (Cal. 1972).Google Scholar
LeBlang, T.R., Informed Consent—Duty and Causation: A Survey of Current Developments, Forum 18: 280, 281 (1983).Google Scholar
See generally Rosoff, A.J., Informed Consent: A Guide for Health Care Providers (Aspen Systems Corp., Rockville, Md.) (1981).Google Scholar
Canterbury v. Spence, supra note 10; Cobbs v. Grant, supra note 10.Google Scholar
Exceptions include research with human subjects governed by the United States Department of Health and Human Services, the United States Food and Drug Administration regulations, and state statutes pertaining to abortion and sterilization. New Drugs, Antibiotic and Biologic Drug Project Regulations: Expert Provisions, 49 Fed. Reg. 2095 (January 18, 1984) (to be codified at 21 C.F.R.§312); Protection of Human Subjects: Informed Consent, 48 Fed. Reg. 11,430 (March 18, 1983) (to be codified at 21 C.F.R. §1003); Mass Gen. Laws Ann. c. 272 §21B (West 1984) (sterilization).Google Scholar
Note, Informed Consent to Immunization: The Risks and Benefits of Individual Autonomy, California Law Review 65: 1286–1314 (1977); Prosser and Keeton on the Law of Torts (West Publishing Co., St. Paul, Minn) (5th ed. 1984) §99 at 694–702 (general products liability law).Google Scholar
Restatement (Second) of Torts §402A comment k (1965).Google Scholar
Davis v. Wyeth Laboratories, Inc., 339 F.2d 121, 130–31 (9th Cir. 1968) (vaccine dispensed to all patients in mass immunization program at clinics without individualized balancing by physician of risks involved); Reyes v. Wyeth Laboratories, Inc., 498 F.2d 1264, 1276 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974); Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977).Google Scholar
Reyes, supra note 17, at 1276; Davis, supra note 17, at 130.CrossRefGoogle Scholar
Givens v. Lederle, supra note 17, at 1345; Note, Mass Immunization Cases: Drug Manufacturers’ Liability for Failure to Warn, Vanderbilt Law Review 29(1): 235–66 (January 1976).Google Scholar
See McLaughlin, , supra note 5.Google Scholar
See generally Flesch, supra note 3.Google Scholar
Powers, R.D., Sumner, W.A., Kearl, B.E., A Recalculation of Four Adult Readability Formulas, Journal of Educational Psychology 49(2): 49 (April 1958).Google Scholar
Id.Google Scholar
Spadaro, D.C., Robinson, L.A., Smith, L.T., Assessing Readability of Patient Information Materials, American Journal of Hospital Pharmacy 37: 215–21 (1980).Google ScholarPubMed
See McLaughlin, , supra note 5.Google Scholar
Doak, C.C., Doak, L.G., Root, J., Patient Comprehension Assessment Study (U.S. Government Printing Ofc., Washington D.C.) (1979) (report issued to Bureau of Medical Services, Public Health Service).Google Scholar
See Flesch, , supra note 3, at 161–65.Google Scholar
See Doak, , et al., supra note 26.Google Scholar
Hoar, N., Hoar, M.E., Readability Formulas: Are They Enough? Contemporary Pharmacy Practice 4: 145–49 (1981).Google Scholar
See Doak, , et al., supra note 26.Google Scholar
Since our study began, the Public Health Service form studied here, “Important Information about Polio and Polio Vaccine,” has been revised. Despite its changes, many of the problems with the level of language remain. Its readability level, as measured by SMOG, is now at 10.5 (at or near “average”). Yet, it still fails to explain fully some phrases (“wild polio”) and gives elaborate, even overdrawn, explanations of others (mechanism of infection). It appeals for consent on the basis of a negative emotional load (“even though we may not have much wild polio virus spreading here now, there is so much of it in the rest of the world that there is great risk of it being re-established if our children are not vaccinated”). Is this form more comprehensible than the old one? Will it improve informed consent? These questions cannot be answered by a readability formula for it tests only one aspect of the comprehension process.Google Scholar
Kaufer, D.S., Steinberg, E.R., Toney, S., Revising Medical Consent Forms: An Empirical Model and Test, Law, Medicine&Health Care 11(4): 155–62 (September 1984).CrossRefGoogle Scholar
Davidson, A., et al., Limitations of Readability Formulas in Guiding Adaptations of Texts: Technical Report No. 162 (Center for the Study of Reading, University of Illinois (1970).Google Scholar
Manning, D., Writing Readable Health Messages, Public Health Reports 95(5): 464–65 (1981); Revising Medical Consent Forms, supra note 32, at 160.Google Scholar
See, e.g., Doak, , et al., supra note 26.Google Scholar
See Meisel, A., Roth, L., What We Do and Do Not Know about Informed Consent, Journal of the American Medical Association 264(21): 264, 2476 (November 27, 1981).Google Scholar