Michael's definition of an informed patient makes sense, but how do you know whether the patient truly understands this?

A recent New York Times article describes research into the attitudes of patients who participate in clinical trials.

You can read the story here: http://www.nytimes.com/2011/03/03/health/views/03chen.html

But here's the takeaway:
The ethicists surveyed 70 patients enrolled in several early-phase cancer trials and asked them about their expectations and understanding of their respective trials. A solid majority understood that the trials’ purpose was to advance research, not to treat them. But despite clearly understanding the purpose, and limits, of early-phase trials, the patients were also blinded by what researchers called an “unrealistic optimism,” or an optimistic bias, when it came to applying that knowledge to their own particular situations. A majority of patients assumed that the experimental drugs would control their cancer and that they would experience benefits but not complications.

cheers,
Christie
        
Christie Aschwanden
www.christieaschwanden.com


On Mar 9, 2011, at 2:26 PM, Michael Power wrote:

Thanks Caroline
 
I haven’t looked closely at the ethical problems of including a placebo arm in a controlled trial. But, I can’t see how a placebo arm could be considered unethical if participants were (a) fully informed; (b) their preferences were documented and included in the analysis of the results;  and (c) their choice was freely made and clearly documented.
 
By fully informed I mean that patients in the trial understand:
·         The estimated chance of benefits, and the uncertainties around these estimates — there are 2 types of uncertainty:  (i) precision, eg 95% confidence interval) and (ii) accuracy, ie risks of biases
·         The estimated chance of harms, and the uncertainties around these estimates
·         That framing the presentation of benefits and harms can change people’s decisions, so these need to be looked at from opposing points of view.
 
And, that they were helped to understand and communicate the values that they place on the potential benefits and harms.
 
The ethics of offering a placebo treatment are different outside a controlled trial. In this case I think that, after diligent consideration of the issues, most people would consider it unethical to offer a placebo treatment without full disclosure and informed consent.
 
If the placebo treatment is surgical, and this has been found to be more effective than current medical treatment, one would have to ask, in the trials providing the evidence:
·         Were the patients fully informed according to the criteria above?
·         Were the results biased, eg by “resentful demoralization”? (see reference 1, 2)
·         Were the providers of the medical treatment optimizing their opportunities for ethically enhancing desirable placebo effects?
 
The answers to these questions might change your gut feeling that placebo surgery treatment is evidence-based and ethical.
 
Because people (patients, providers, researchers) find it difficult to understand and communicate risk and uncertainty, these may be impractically high standards to meet. But, this is not a justification for not trying.
 
Michael
 
References
 
1 Cook TD, Campbell DT. Quasi-experimentation: design and analysis issues for field settings. Chicago: Rand McNally, 1979