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Longer Consent Forms for Clinical Trials Compromise Patient Understanding: So Why Are They Lengthening?

Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia

To the Editor:

Participation in cancer clinical trials is essential to ensure ongoing improvements in the management of people diagnosed with cancer. It is generally accepted that subjects in a clinical trial should understand a minimum amount of information to provide informed consent. Understanding the diagnosis, prognosis, nature and purpose of the intervention, alternatives, and risks and benefits are generally considered essential. Patient information and consent forms (PICFs) are an important part of communicating this information. Despite this, patient knowledge and adequacy of informed consent to clinical trials has been demonstrated to be suboptimal.^1,2

We performed a study to assess knowledge and satisfaction regarding the informed consent process concerning cancer clinical trials.² Our team studied a convenience sample of 102 patients, participating in 27 therapeutic clinical trials across four hospitals. Part of this study involved a review of the PICFs. The forms were assessed for the total number of pages, and readability and grade level was determined using the grammar function of Word 97 for Windows (Microsoft Corp, Redmond, WA). In addition, the forms were scored for their degree of compliance with the recommendations of the National Cancer Institute (Bethesda, MD) consent form template.³ Patient knowledge was assessed using a patient-completed measure, the quality of informed consent (QuIC) questionnaire, which was designed to measure a participant's actual (objective) and perceived (subjective) understanding of cancer clinical trial involvement.⁴ Separately, we examined the length of PICFs (presented in a standard format) for all cancer clinical trials commencing at one of the involved hospitals—Peter MacCallum Cancer Centre (East Melbourne, Australia)—during a 6-year period (2000 to 2005 inclusive).

Patient knowledge regarding cancer clinical trials was good² and similar to published US data.¹ However, within our study of 27 PICFs, the average reading level was grade 11 despite 8.8% of patients stating that English is their second language and 14.7% having nine or fewer years of education. The average PICF was eight pages long (range, five to 12). Compliance with the National Cancer Institute template was generally good, with a median of 80% of the recommended content present within the forms (range, 55.6% to 86.1%). However, significant information was frequently missing (Table 1).

View larger version (10K): [in this window] [in a new window] [PowerPoint Slide for Teaching]   Fig 1. Page numbers of consent forms during a 5-year period.

A concerted effort is required to revise the content and presentation of PICFs so pertinent information is presented in a succinct and easy-to-read format. PICFs are an important part of the consent process, but they rarely comply with the recommended grade 8 reading level, and they are becoming longer with time.^4,5 These factors are significantly compromising patient knowledge to the detriment of clinical trials and our patients.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author indicated no potential conflicts of interest.

REFERENCES

1. Joffe S, Cook EF, Cleary PD, et al: Quality of informed concent in cancer clinical trials: A cross-sectional survey. The Lancet 358:1772-1777, 2001

2. Jefford M, Mileshkin L, Raunow H, et al: Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem. J Clin Oncol, 23:16S, 2005 (abstr 6067)

3. Comprehensive Working Group on Informed Consent in Cancer Clinical Trials. Recommendations for the development of informed consent documents for cancer clinical trials. http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/page1

4. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 93:139-147, 2001[Abstract/Free Full Text]

5. Kirsh I, Jungeblunt A, Jenkins L, et al: Adult literacy in America: A first look at the results of the National Adult Literacy Survey. Washington, DC, National Center for Education Statistics, US Department of Education, 1993

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