Abstract
Paul Appelbaum and colleagues first observed that very ill patients enrolled in research often exaggerate the anticipated personal benefits of experimental treatments (Appelbaum et al., 1982). They described and diagnosed the problem of the ‘therapeutic misconception’, concluding that patients assumed their clinician would treat them in their best interests and they would not understand the apparently contradictory nature of the research’s primary aims to pursue science (Appelbaum et al., 1982). Subsequent work has shown that patients may understand the individual features of research, such as randomization, but do not always find them acceptable or recognize that they can lead to better scientific knowledge (Kerr et al., 2004). Reluctance to recognize that their doctor can be completely uncertain as to the treatment’s effects, however, may also be seen in the routine treatment as well as in research (Robinson et al., 2004). The result in these experiments has recently been borne out by a larger and more comprehensive review of different medical treatments, which reported that patients tended to overestimate personal benefits and underestimate the risks (Hoffmann and Del Mar, 2015). There seems to be more going on than patients trying to resolve perceived contradictions between dual objectives between research and therapy. Indeed, recent data from advanced Parkinson’s patients enrolled in a sham surgery neurological trial showed that therapeutic misconception was not associated with a desire for seeing one’s own clinician as the site scientist (Kim et al., 2015a). As a result, we might expect the problem also to arise when new treatments are licensed outside research conditions early, or where unlicensed treatments are used out of compassion when the intention is solely to benefit the patient but when supportive clinical data are very weak.
Without obvious untruths, patients are sometimes misled into unrealistic optimism, which is always a concern, especially with experimental therapies. For example, Kim and colleagues studied the following simple phrase on information sheets for a hypothetical early phase trial of the serious condition, amyotrophic lateral sclerosis: ‘it is not guaranteed that you will benefit’ (Kim et al., 2015b). They found that, after reading it, respondents’ estimates of expected personal benefit were higher than after reading the phrase ‘some, but very small chance of benefit’ (Kim et al., 2015b). The former phrase, however, implies that there is substantial, if not complete, confidence in personal benefit and it could, therefore, be misleading and perhaps even be used manipulatively. Work on framing effects and the like have brought this kind of hitherto unrecognized manipulation of information to the fore, and ethics committees should remain vigilant towards it.
However, information given to patients could be given optimistically without its being either false or misleading. Patients in one study referred to needing to be positive as an explanation for their exaggerated estimates of personal benefit at the same time as understanding the statistical data (Sulmasy et al., 2010). In addition, patients’ expressions of optimism may also be intended to comfort family rather than report an epistemic state (Weinfurt et al., 2003). In another study, Weinfurt and colleagues (2009) found that patients’ expectations of personal benefit were significantly greater when asked subjective belief-type questions than when asked relative frequency-type questions (Weinfurt et al., 2008). Different conceptions of probability could come into play with subjective beliefs concerning likelihood of personal benefit being numerically higher (and psychologically richer) than the objective measure of relative frequency, which cannot conceptually refer to personal benefit at all, but only to abstract proportions of reference populations (e.g. 5 in 1000).
Once having made a decision and invested time and emotion (and, of course, money) in treatment, a positive attitude is often thought to improve some outcomes (Victoria Cerezo et al., 2014), perhaps by enhancing the placebo effect (Reicherts et al., 2016), making some optimism self-fulfilling and rational.
It seems clear that we have not yet got to the bottom of the now familiar and prevalent therapeutic misconception, if indeed there is one. As a result, more work is needed to disentangle those cases where risks and expected benefits have been misunderstood and those cases where a positive expectation and belief in personal benefit simply reflects an optimistic attitude to life. Without hope, there is only despair.
Editor’s choice
In this Issue and as a counterpoint to current thinking about the ‘therapeutic misconception’ in the Editorial, Chavez and colleagues present conversational data from parents and their healthy adolescent offspring (aged 14–17 years) discussing participation in a phase 1 sexual health trial. Despite some methodological weaknesses, the study shows how parents develop initial thoughts about being altruistic. Although the participants are legally competent to consent to treatment in their best interests, these data support the notion that it is still important to involve parents in decisions about adolescent research.
The second article, by a Masters student, Bonnie Scarth, reports the views of bereaved parents who wished to be identified in a qualitative study and in any subsequent publication. Rather than becoming too distressed by such a sensitive subject area, some of the respondents wished to use publication to bring the deceased into common consciousness and public memory.
Another student, this time a Doctoral student, Bianca Fileborn, encountered difficulties when recruiting young adult participants (18–30 years) to a project on unwanted sexual attention in licensed premises via her personal online Facebook account, leading to loss of control over how and where the study was promoted, confusion over how to respond to queries, or comments about the project on other sites, and ambiguity over exactly who was participating as a ‘subject’.
Lastly, we invite commentaries on our case study submitted by Herringshaw and Davies on how controversial research into fracking should be funded and governed.