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At least 19 recordsLinked to original sources
PubMed1990

Readability of pediatric biomedical research informed consent forms.

Informed consent forms are used in biomedical research as a mechanism to convey study information to potential subjects so that they may arrive at a decision concerning their willingness to participate. Although the Department of Health and Human Services Regulations for the Protection of Human Subjects require the presentation of specific study information at a level that is easily understood, according to research concerning adult biomedical consent forms, the typical form is not readily comprehensible. Unfortunately, no data exist concerning the readability of informed consent forms that are used in the context of pediatric biomedical research. In the present study, readability analyses were conducted on a large sample (N = 238) of pediatric biomedical informed consent forms obtained during a 10-year period from a large midwestern children's hospital. For the entire sample, results derived from two readability estimates (Fry grade equivalent and Flesch Reading Ease methods) indicated that the consent forms were written at the college graduate level. Although there was a linear increase in the length of the consent document during the 10-year period evaluated, expanded length was not associated with improved readability. According to analyses, a differential pattern of reading difficulty was associated with specific sections of the informed consent document. Findings are highly consistent with those from studies of adult biomedical consent form and document that the purpose of the informed consent form is being compromised, in part, by a readability factor. Suggestions for solving this critical problem are advanced.

Comprehension↗
PubMed2001

Obtaining consent: the use of a consent form.

A consent form provides clear, unambiguous proof that a patient consented to treatment. Consent forms do not reveal the content of discussions with a patient. Staff awareness needs to be raised of the importance of providing information, obtaining consent and demonstrating that this has occurred.

Documentation↗
PubMedDate not supplied

A risk-specific anesthesia consent form may hinder the informed consent process.

STUDY OBJECTIVE: To evaluate the effect of a preprinted, risk-specific consent form on the amount of anesthetic risk information patients retain from the preoperative interview. DESIGN: Postoperative survey of consecutive inpatients to determine risk information retained before and after implementation of a preprinted anesthesia consent form, using standard preoperative risk discussions. SETTING: Inpatient units of a university medical center. PATIENTS: Two groups of patients, both of whom received a standard oral discussion of anesthetic risk information, were compared. Patients in the control group (125 consecutive inpatients) received this information only orally and were interviewed two weeks prior to implementation of a preprinted anesthesia consent form. Patients in the study group (92 consecutive inpatients) received this information orally and via a preprinted consent form and were interviewed between the fourth and sixth weeks after implementation of a preprinted anesthesia consent form. INTERVENTIONS: Anesthesia residents discussed five standard anesthetic risks with elective, adult inpatients (n = 233) during a two-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. These patients were interviewed postoperatively by one of the authors to determine the amount of anesthesia risk information they retained. MEASUREMENTS AND MAIN RESULTS: Results of the postoperative survey showed that patients in the control group retained more information concerning anesthetic risks than did those in the study group (33% vs 19%, p less than 0.01). CONCLUSIONS: To improve the informed consent process, either a better method of presenting the preprinted, risk-specific consent form or another method of simultaneously conveying and documenting risk information is needed.

Anesthesiology↗
PubMed1980

How readable are subject consent forms?

A consent to treatment form provides required information that a patient may use to give intelligent, informed consent to proposed treatment. This study applied two standard techniques to assess the degree to which 60 informed consent forms from five national cancer clinical trial groups were readable and understandable by patients. The forms were found slightly less difficult to comprehend than medical journals but substantially more difficult than comparable materials from the popular press. Three of four passages describing treatment methods, procedures, discomforts, and risks required a college level or greater reading ability to comprehend. Informed consent documents may not be understood by a substantial portion of patients who sign them. The very regulations designed to ensure a patient's informed cooperation with treatment may inadvertently lead to forms that are so complex as to make informed cooperation virtually impossible.

Documentation↗
PubMedDate not supplied

Excluding particular information from consent forms.

Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.

Communication↗
PubMedDate not supplied

Development of a model angiography informed consent form based on a multiinstitutional survey of current forms.

PURPOSE: To develop an informative consent form for angiography that can be read and understood by a patient with an eighth-grade level of education. MATERIALS AND METHODS: Consent forms from 125 medical centers were evaluated with RightWriter 4.0 software. The readability index, a measure of educational grade level needed to understand a document, was determined for each form. Features of forms and discussion of complications were evaluated. A model consent form was developed. RESULTS: Analysis of 27 consent forms revealed a mean readability index of 14.2; to adequately understand the documents, an average of 2.2 years of college were required. Alternatives to the procedure were listed in 14 forms (52%). All consent forms listed potential complications, but only 15 (56%) identified specific numeric risks, and attempts to classify complications according to severity were made in only five (18%). CONCLUSION: An angiography consent form has been developed that can be understood with an eight-grade level of education. It should allow patients to more easily understand the procedure and its risks, benefits, and alternatives. It remains the obligation of the physician to tailor the discussion for each procedure to meet the needs of each patient.

Academic Medical Centers↗
PubMed1992

Institutional Review Board (IRB) review lacks impact on the readability of consent forms for research.

Consent forms in research are a source of current and retrospective information for the subject, a "prompt" for the person who is obtaining consent, and a documentation of the "informed" consent process and its adequacy. Occasionally, these forms may be administered by inexperienced trainees or ancillary personnel, and thus stand virtually alone. Therefore, the forms must be inherently comprehensible to the subjects. To test whether this is the case, 65 new applications were randomly selected from 13 consecutive IRB agendas, and their consent documents were computer-analyzed (Flesch/Fry scoring) after correction for expected confounding features, such as lists, tables, and polysyllabic proper names and jargon. Mean U.S. school grade for 70% comprehension (Fry score) was 15.03 +/- 0.19 (standard error of the mean), implying readability by 37.4 +/- 1% of the U.S. adult population. In contrast, a consecutive sampling of 21 Ann Landers columns yielded a mean Fry score of 7.67 +/- 0.5 (p < 0.01; readable by 75 +/- 3%). Fifteen Reader's Digest articles yielded a mean Fry score of 9.95 +/- 0.65 (p < 0.01; readable by 59.1 +/- 3%), and 15 "Talk of the Town" columns from The New Yorker averaged a grade level of 13.3 +/- 0.83; p < 0.01; readable by 42.7% +/- 4.8%). No document was improved by more than one grade level by the IRB review process, and most were unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)

Comprehension↗
PubMed1996

Consent form readability in university-sponsored research.

BACKGROUND: Consent forms are required in most biomedical research involving human subjects. In recent years, a number of studies from different disciplines have reported problems related to consent form readability. METHODS: We analyzed 284 consent forms submitted to and approved by five institutional review boards (IRBs) (schools of Medicine, Nursing, Academic Affairs, Dentistry, and Public Health) at one university and one IRB at another. We examined consent form readability scores and factors that might relate to readability. RESULTS: The average reading level of all consent forms was high: 12.2, which corresponds roughly to a 12th-grade reading level. Less than 10% of all consent forms were written at a 10th grade reading level or below. Thirty-two percent of all consent forms had no evidence of revisions, and less than 2% of consent forms were revised more than once. Readability scores were not related to consent form revisions, the type of IRB, the year of study, or the university where the research was conducted. CONCLUSIONS: Poor readability of consent forms probably occurs in all university-related research. We recommend that IRBs require readability checks for research consent forms before researchers submit their proposals to an IRB.

Comprehension↗
PubMed1998

The readability of currently used surgical/procedure consent forms in the United States.

BACKGROUND: Informed consent forms are universally used by hospitals throughout the United States before surgery or invasive procedures. This survey was undertaken to determine the content of these forms and their ability to be understood by individuals with differing reading comprehension levels. METHODS: Ten percent of all U.S. hospitals were requested to forward a copy of their current surgical/procedural informed consent form. The forms received were digitized and computer assessed for readability. In addition, each form was evaluated for a variety of items with respect to content. RESULTS: Of the 2194 requests mailed, 681 responses were received including 616 with surgical/procedural consent forms. The mean grade level required to understand these consent forms was 12.6 (+/- 3.1). There was no variability in readability scores on the basis of hospital bed size. Of the 616 consent forms reviewed, 29, 146, 347, and 461 forms could be understood by individuals reading at a grade level of less than 8 and at least 8, 10, and 12 years of education, respectively. Although most required the name of the patient, physician, and procedure, the majority did not describe or provide a full-in blank for the specific benefits, risks, and alternatives to the procedure. CONCLUSIONS: The majority of surgical/procedural informed consent forms currently used by U.S. hospitals are complex and are not easily understood by the average patient. In addition, the majority of reviewed consent forms do not list specific benefits or potential complications of the planned surgery/procedure.

Hospitals↗
PubMedDate not supplied

Research consent forms: continued unreadability and increasing length.

Consent forms are often long and incomprehensible. The authors studied 88 consecutive research consent forms generated at the Denver Veterans Administration Medical Center, evaluating the reading levels of the forms using the Fry Readability Scale and recording the numbers of lines of text. The mean grade reading level required for comprehension was 13.4 years of schooling. Twenty-two percent of all text passages scored were at the postgraduate level of readability. This difficult readability level has not improved since the forms were last tested in 1982. The mean length of the forms was 84.6 lines. Also found was a 58% increase in the length of forms since 1982, a factor known to impair comprehension. These factors, poor readability and increasing length, may make many consent forms incomprehensible. It is recommended that investigators be brief, use plain English, and write consent forms at appropriate reading levels, and receive training on how to obtain valid consent.

Colorado↗
PubMed1993

Readability of informed consent forms for use with iodinated contrast media.

Informed consent forms used before intravenous administration of contrast media by both private practice (Pennsylvania Blue Shield) and academic (Association of University Radiologists) physician groups were analyzed to evaluate for readability and content. Most of the 160 consent forms required at least a high school education to be understood; 10 (6%) required a college education. Consent forms from academic institutions tended to be longer and contain more problems with sentence structure than those from private practice. Consent forms from both groups tended to have a weak, wordy writing style. Although most of the consent forms discussed at least some of the potential adverse reactions from intravenous contrast media, 37 (23%) made no mention of any potential adverse reaction. Indeed, 25 (16%) made no mention of contrast media at all. Only 12 (8%) consent forms included a discussion of nonionic contrast media. The authors provide sample consent forms that cover the common risks of ionic and nonionic contrast media and describe the availability of nonionic contrast media; these forms are understandable by an individual reading at only an eighth-grade level.

Comprehension↗
PubMed2001

Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process.

OBJECTIVE: Informed consent is a required part of clinical research. Industry consent forms may be complex and difficult to understand. A comparison was performed between a standard, industry consent form (IF) and a modified, shortened version of the same form (MF) to determine which allows the patient to retain more information in the immediate postconsent period. METHODS: This was a prospective, randomized study performed in an urban, county teaching emergency department (ED). A convenience sample (based on the availability of one of two research assistants being present in the ED) of 100 patients with a history of asthma seen in the ED were enrolled. After reading the consent form, 50 MF and 50 IF patients were given a postconsent test to determine how much information was retained. Mean differences in test scores between the IF and MF were determined. RESULTS: The population had a mean age (+/-SD) of 39.4 +/- 12.1 years (range 18-80); 52% were female. The overall score for the study population was 9.6 (+/-2.0), range 2-12 (maximum 12). The MF score was 10.6 (+/-1.4) vs the IF score of 8.6 (+/-2.1); mean difference = 2.0 (95% CI = 1.3 to 2.7, p < 0.0001). The MF group had significantly more correct answers than the IF group with the following questions (MF%, IF%; mean difference in proportions with 95% CIs): purpose (96, 70; 26, 95% CI = 12 to 40); randomization (78, 44; 34, 95% CI = 16 to 52); study duration (94, 70; 24, 95% CI = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits (94, 78; 16, 95% CI = 3 to 29); alternative treatments (88, 70; 18, 95% CI = 2 to 34); confidentiality (98, 88; 10, 95% CI = 0.2 to 20); and voluntary participation (74, 54; 20, 95% CI = 2 to 38). Adverse event compensation had the poorest correct rate (54, 38; 13, 95% CI = -6 to 32). Subsequently, after taking the postconsent test, 98% wrote that they read the entire MF, while only 68% wrote that they read the entire IF (mean difference in proportions 30%, 95% CI = 17% to 43%). CONCLUSIONS: Compared with an industry consent form, a shortened version, focusing on Food and Drug Administration and Department of Health and Human Services informed consent guidelines, allowed patients to retain more information in the immediate postconsent period.

Adolescent↗
PubMed1995

Informed consent forms for clinical and research imaging procedures: how much do patients understand?

OBJECTIVE: Informed consent is often obtained in diagnostic radiology, especially for invasive procedures and research studies. However, how much the average patient actually understands of the information contained in these informed consent forms is uncertain. A cross section of the clinical and research consent forms used in diagnostic radiology was evaluated with respect to their readability, that is, how easy or difficult they were to understand. MATERIALS AND METHODS: The active members of the Association of University Radiologists were solicited to provide copies of their clinical and research informed consent forms. After eliminating duplicates, we digitized the forms and used a computer program to evaluate their readability. Computer readability assessment allows the rapid study of an entire document by a variety of readability formulas (Flesch-Kincaid, Flesch, and Fog). RESULTS: We received 549 different consent forms from 156 institutions; 265 forms were intended primarily for clinical use and 284 were used primarily for research. Although the clinical consent forms were only 41% as long as those for research, a statistical comparison showed them to be harder to understand (p < 0.005). The mean readability score (years of education needed to understand) for all 265 clinical consent forms was 15 versus 12 for the research forms. The most complex clinical consent forms were those written by hospitals for any type of procedure or operation (the generic surgical or procedure consent form). On average, this type of clinical consent form required at least a college education to understand. CONCLUSION: Our results show that most consent forms used in radiology practice are too complex for the average patient to understand. The increased complexity of clinical consent forms, especially the generic surgical or procedure consent forms, as compared with research consent forms, is probably a product of the decreased attention given to the clinical consent forms, the bureaucratic and legal requirements of the clinical forms, and the lack of physician participation in preparing these forms.

Cognition↗