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Improving Informed Consent in Clinical Trials: Successful Piloting of a Decision Aid

Medical Psychology Research Unit, School of Psychology, University of Sydney, New South Wales, Australia

Margaret Seccombe

Australian New Zealand Breast Cancer Trials Group, University of Newcastle, New South Wales, Australia

Fran Boyle

Pam McLean Cancer Communications Centre, University of Sydney, New South Wales, Australia

Nicole McCarthy

Department of Medical Oncology, Royal Brisbane Hospital, Queensland, Australia

John F. Forbes

Australian New Zealand Breast Cancer Trials Group, University of Newcastle, New South Wales, Australia

To the Editor:

We read with interest the article by Wallace et al¹ evaluating the impact of a patient-based educational intervention on patient accrual to a large randomized controlled trial (Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial [SPIRIT]). We agree that interventions to improve the process of consent are vital. Accrual is of course an important end point, but another critical outcome is the degree to which patients achieve informed consent. Failure to understand the intricacies of the trial may therefore not only compromise trial accrual, but also the process of informed consent. This is important not only on ethical grounds, but also will likely influence dropout rates, which in turn may limit study conclusions. As many clinical trials require compliance with therapy and assessment regimes over long time periods, it is important that only fully informed and motivated participants are randomly assigned. As two new participants are required for every patient who does not receive their allocated treatment,² interventions to reduce dropout are also important for the success of the study.

One intervention that has been widely used to promote informed choice in the standard treatment context is the decision aid. Decision aids typically contain evidence-based information presented in a simple, graphical form and lead patients through a process of clarifying their values and weighing the pros and cons of the options before decision making.³ A systematic review of decision aid randomized trials has shown that patients who receive decision aids have improved knowledge, more realistic expectations, less difficulty in reaching a decision, higher satisfaction with the decision-making process and no more anxiety than those who do not.³ However, this intervention has rarely been evaluated in the context of clinical trials.

Our group has developed and piloted a decision aid based on the Ottawa decision aid framework⁴ for use in Australian New Zealand Breast Cancer Trials Group (ANZ BCTG) centers participating in the International Breast Cancer Intervention Study II (IBIS-II). The aim is to assist postmenopausal women at high risk of developing breast cancer who are considering participation in the IBIS-II study in making an informed choice between trial participation and standard risk management options. Postmenopausal women are being recruited for: IBIS-II Prevention, which involves women at increased risk of breast cancer who have not had a previous breast cancer unless it was ductal carcinoma in situ (DCIS) treated by unilateral mastectomy; and IBIS-II DCIS, which involves women who have previously been diagnosed with DCIS which has been treated by local excision. In IBIS-II DCIS women receive 5 years of either 1 mg daily of anastrozole or 20 mg daily of tamoxifen (double blind). In IBIS-II Prevention women receive either anastrozole, 1 mg daily for 5 years, or placebo (double blind). As this is a healthy population, and the data on anastrozole and tamoxifen (for IBIS-II DCIS) requires extrapolation from early stage breast cancer trials, there are many complex issues for potential participants to understand and consider.

The DCIS decision aid includes text, tables, and graphical information relevant to the decision whether to participate in the trial. The clinical context (increased risk of developing breast cancer after DCIS) is clarified, as are the advantages and disadvantages of standard care versus trial participation, including the efficacy and adverse effects of tamoxifen and anastrozole, and tests and procedures. The broad rationale for clinical trials is presented and the concepts of random assignment and blinding explained. Personalized worksheets are provided to help participants evaluate how important each risk and benefit is to them (value clarification exercises).

A group of women who are currently in follow-up for the previous breast cancer prevention trial (IBIS-I)⁵ at the ANZ BCTG, Newcastle Mater Hospital, IBIS-I follow-up clinic were invited to participate in a pilot of the DCIS decision aid. Women were asked to read the IBIS-II DCIS information sheet and then the DCIS decision aid booklet, complete a set of standardized questionnaires, and provide verbal feedback on the decision aid via a semi-structured telephone interview. Of 37 women invited, 31 (84%) agreed to participate.

After reading the decision aid, women reported that they had a very good understanding of the key elements of the IBIS-II trial, as measured by the Quality of Informed Consent Part B⁶ scale. An objective assessment of women's knowledge of trials in general and IBIS-II revealed high levels of understanding (women scored on average 16 of 19 items correctly). The women's attitudes to the IBIS-II trial were strongly positive, with 97% reporting leaning toward hypothetical participation in the trial. The decision aid did not appear to increase participants' anxiety; mean reported anxiety, as measured by the state scale of the State-Trait Anxiety Inventory,⁷ was equivalent to that of age-matched healthy women.

More than 90% of women found the decision aid helpful regarding trial participation and understanding the information sheet, and in providing useful additional information to the information sheet. Participants reported that the decision aid presented the standard risk management options and the clinical trial option in a balanced way (97%). Receiving both the decision aid booklet and the information sheet was preferred to receiving only the latter (90%). As one woman noted during the interview, "It [the decision aid] is more interesting to look at and read than the information sheet. You can read it straight through—the presentation makes it more appealing and easier to read than pages of plain text [in the information sheet]." Another woman stated: "The [decision aid] booklet makes women aware of their concerns—how they feel about certain aspects of the trial and to base their decision on that." Participants also noted the value of the decision aid beyond the decision-making stage, seeing it as a "good reference book for going back and looking at side effects as you progress through the trial."

It is important to note that the pilot participants had already been on a trial, and are likely to be more knowledgeable and positive about trial participation than women who are considering trial participation for the first time. However, the participants were also likely to have sound knowledge of the information needs of people on a trial and therefore should be able to provide informed feedback about the value of the decision aid.

A randomized controlled trial evaluating the effectiveness of the revised decision aid in improving informed consent will soon commence with the ANZ BCTG IBIS-II centers. If successful, this relatively simple innovative strategy has the potential to improve the process of gaining informed consent in large, multicenter trials, and may lead to lower dropout rates. Full results of this pilot study will be published separately.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

ACKNOWLEDGMENTS

This study is supported by a KOMEN Breast Cancer Foundation grant and the Australian New Zealand Breast Cancer Trials Group.

REFERENCES

1. Wallace K, Fleshner N, Jewett M, et al: Impact of a multi-disciplinary patient education session on accrual to a difficult clinical trial: The Toronto experience with the surgical prostatectomy versus interstitial radiation intervention trial. J Clin Oncol 24:4158-4162, 2006[Abstract/Free Full Text]

2. Simes RJ: Controlled clinical trials, in Kerr C, Taylor R, Heard G (eds): Handbook of Public Health Methods. Sydney, Australia, McGraw Hill, 1997, pp 130-136

3. O'Connor AM, Roston H, Fiset V, et al: Decision aids for patients facing health treatment or screening decisions: Systematic review. BMJ 319:731-734, 1999[Abstract/Free Full Text]

4. O'Connor AM, Tugwell P, Wells G, et al: A decision aid for women considering hormone therapy after menopause: Decision support framework and evaluation. Patient Edu Counsel 33:267-279, 1998[CrossRef]

5. Cuzick J, Forbes J, Edwards R, et al: First results from the International Breast Cancer Intervention Study (IBIS-I): A randomized prevention trial. Lancet 360:817-824, 2002[CrossRef][Medline]

6. 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]

7. Spielberger CD: Manual for the State-Trait Anxiety Inventory. Palo Alto, CA, Consulting Psychologists Press, 1983

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