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the informed consent form: document development and evaluation

the informed consent form: document development and evaluation

1310 Mark Hochhauser

1310 Mark Hochhauser METHODS per million words or less), however, may The researcher is a member of the Institu- tional Review Committee (IRC) at North Memorial Medical Center, Robbinsdale, Minnesota. With permission from the IRC chair, the IRC secretary randomly selected 12 informed consent forms for investigational drugs studies submitted to the committee in 1999. The consent forms were scanned into a computer, optically read by Textbridge Pro 9.0, and analyzed by seven DOS-based software programs: Corporate Voice, FS Text, Key Grammar, Prose, Pro-Scribe, Reader, and WStyle. Each of these programs provides different statistical data that can help assess the “plain English” characteris- tics of the consent forms. present serious reading problems. If research participants do not read much, they probably will not encounter many of these uncommon words, so when they see them in the consent form, they will have a hard time reading and understanding them. Word familiarity has been shown to be a major factor in a reader’s ability to under- stand written materials. Since word fre- quency is a good estimate of word difficulty, words that do not appear in print very often are harder to read and understand than words that appear frequently (7). Too many uncommon words will make a consent form virtu- ally incomprehensible to the “average” reader. Waggoner (8,9) has identified many research-related words and phrases that people RESULTS AND DISCUSSION do not understand very well, including: effi- NCI Recommendations (in italics) and Comments cacy, double-blind, washout period, protocol, randomly, Institutional Review Board, base- line visit, concurrent drugs, sponsor, and so forth. Prospective participants have a hard “Words are familiar to the reader. Any scientific, time understanding not only words, but basic medical, or legal words are defined clearly.” clinical research concepts as well. As shown in Table 2, the 12 consent forms Unfortunately, the NCI does not define used too many uncommon words, making “familiar words” or give consent form writers both reading and comprehension more diffi- any strategies to determine familiar and unfacult for the prospective research participant. miliar words in an informed consent form. There are, however, translations of unfamil- Words that are commonly used by researchiar medical terminology into familiar mediers may be completely unfamiliar to prospec- cal terminology (10,11), such as those shown tive participants. One way to more systematically approach this issue is to consider the in Table 3. frequency with which words appear in written documents. Table 1 categorizes the word “Sentences are short, simple, and direct.” frequency of some words from 12 investiga- Although the NCI does not define short, tional drug study consent forms reviewed by simple, and direct, the work of Rudolf Flesch the North Memorial Medical Center Institu- (12) has been influential in establishing some tional Review Committee. basic guidelines. Flesch recommended that Word frequency was based on The Educa- sentences average about 15 to 17 words for tor’s Word Frequency Guide (6). This guide maximum readability. The 12 consent forms calculated word frequency based on 17 mil- averaged 20 words per sentence, which is lion words from 61000 samples of text from not too far from the recommended range. over 6000 written materials used in Ameri- Beyond calculating the number of words can schools and colleges. Most readers would per sentence, some software programs (eg, probably be able to read and understand Corporate Voice) can categorize sentences as words with a frequency of 100 per million simple and normal; or wordy, pompous, and words or greater. The uncommon words (30 complicated. While that program suggests

Informed Consent Forms 1311 TABLE 1 Word Frequency Analysis of 12 Informed Consent Forms Word Frequency Examples 10000/million words a, and, are, as, for, in, is, it, of, on, one, that, the, to, with, you 3000/million words about, an, be, from, had, have, if, into, like, more, no, not, or, other, out, people, so, there, this, time, up, we, when, who, will, your 1000/million words after, also, any, because, even, every, first, food, help, how, however, important, know, made, make, may, me, might, most, much, must, my, new, only, part, see, should, such, take, used 300/million words able, become, care, done, given, group, information, known, let, low, need, number, possible, problems, questions, read, study, sure, understand, without 100/million words available, blood, cells, chance, choose, continual, decision, determine, doctor, explain, follow, future, health, heart, hour, immediately, loss, months, occur, physical, purpose, receive, related, remain, research, results, safety, sign, similar, skin, test, visit 30/million words additional, administration, appropriate, approximately, assigned, benefit, bone, cancer, circumstances, commonly, data, discuss, drawn, drug, examination, female, include, laboratory, legal, maximum, mild, needle, otherwise, pain, plus, potential, procedure, routine, severe, site, treatment 10/million words alternative, bleeding, calcium, commitment, compensation, consent, conventional, criteria, customary, disorder, effectiveness, evaluate, functional, governmental, infection, injury, liability, multiple, participate, physician, pregnant, prior, random, risks, specimens, symptoms, withdraw 3/million words aggregate, applicable, assess, capability, chronic, clinical, complications, comply, discomfort, dose, duration, elevated, extensively, incidence, likelihood, medication, monetary, orally, sponsor, theoretical

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