We thank Rowe et al. for their commentary on the issue of informed consent in surveillance for hepatocellular carcinoma in patients with cirrhosis. Our publication1 examined the feasibility of conducting a randomized controlled trial (RCT) for liver cancer screening given current medical practice, patient attitudes, and knowledge in developed nations such as Australia. We fully concur that informed consent needs to outline both the risks and benefits of any surveillance program. To this end, above and beyond the patient information and consent form, we specifically developed a decision aid (DA) in plain English to help in the decision-making process. As outlined in the DA, the disadvantages of screening are discussed in Section 10 (Does screening improve the survival of patients with HCC) and in Section 12, where we ask participants to discuss the DA with the clinician involved and their family physician, including the risks and benefits, the convenience and discomfort from screening tests, and whether surveillance has been proven to reduce the risk of dying from cancer. Additionally, on the last page of the DA we diagrammatically represent the potential advantages and disadvantages of screening, including the inconvenience of clinic visits and ultrasounds and anxiety from false-positive results. Our consent process involved a 30-minute interview with the patient at which time we discussed all their concerns, including the risks and benefits of surveillance. Finally, based on a questionnaire of participants, 56% believed that the information provided was unbiased and nearly 80% thought that the information provided was adequate. Surveillance programs should outline the risks and benefits of the program, including any potential for physical or psychological harm; we believe that this was adequately done in our study. Whether the DA could have been improved is a judgment call, but we would contend that future similar studies can be similarly criticized, on the quality of the DA developed. Most important, we believe, based on our results, that patients in developed countries will elect to have screening, and further, that an RCT as suggested, while ideal, is highly unlikely to eventuate or to put this matter to rest, any more than the present study.
Hossein Poutschi MBBS, PhD* , Jacob George MBBS, PhD, FRACP, * Digestive Disease Research Centre, Tehran University of Medical Science, Tehran, Iran, Storr Liver Unit, Westmead Millennium Institute, University of Sydney and Westmead Hospital, NSW, Australia.