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Results for “Consent Forms”

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At least 19 recordsLinked to original sources

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↗

PubMed1976

A consent form for informed consent.

Explore the source record for details and available documents.

Endoscopy↗

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↗

PubMed1978

Consent forms--how, or whether, they should be used.

If written consent forms are to be used--their use normally is not mandatory--care should be taken that their use is proper and, hence, beneficial. To be of benefit to the physician, the consent forms must help him in meeting his duty to inform the patient or in protecting him from a patient's claim that his was not an informed consent (or both). Consent forms are of no benefit to the physician or the patient if they are worded poorly or put to poor use. Suggestions are provided to help the physician in considering his or her use of written consent forms.

Consent Forms↗

PubMedDate not supplied

Consent forms: how to determine and improve their readability.

This study investigated the reading level estimates of cancer clinical trial consent forms from actively accruing studies at the Medicine Branch and the Clinical Pharmacology Branch of the National Cancer Institute. Forty-four consent forms were analyzed using the SMOG formula. Readability levels ranged from grade 12 to grade 17.5 (mean = 14.3). The conclusion was that these consent forms were written above most subjects' reading levels. The usefulness of consent forms could be improved significantly by using readability formulas, applying rewriting techniques, and being aware of subjects' comprehension levels. This paper suggests a number of strategies that nurses can use to enhance comprehension of the information contained in informed consent documents.

Clinical Trials as Topic↗

PubMed1979

[First experiences with a written consent form for patients prior to cataract surgery (author's transl)].

The first experiences with a written consent form signed by patients prior to cataract surgery are presented. Details of possible surgical complications were discussed with the patient. The average time for this type of discussion was 15,6 min (7--30 min). The positive outcome of this study appeared to be that the confidence of the patient towards the surgeon or the hospital did not suffer nor did any patient change his decision to undergo surgery. This was tasted in a questionnaire showed to the patients after the discussion on possible complications. Some patients stated that they preferred enlightment on the day before surgery, whereas others would have preferred to have the written consent form sent home some days before surgery to have chance to discuss the problems with their relatives.

Cataract Extraction↗

PubMed1992

Evaluating the readability of informed consent forms used in contraceptive clinical trials.

The readability level of informed consent forms used in clinical trials on contraceptives was determined. Three different formulas for measuring readability were used. Some forms received relatively high scores by all three methods. The most common problems associated with high readability scores were the use of 'unfamiliar' words, long words and long sentences. At present all forms used must be readable, using the SMOG formula, at a grade 6 level or less.

Clinical Trials as Topic↗

PubMed1978