Is it important to disclose how treatments are selected in clinical research and clinical care?

BACKGROUND

Current practice and policies maintain that it is very important to disclose to potential research subjects that their treatment will be selected by randomization. In contrast, it typically is not considered important to disclose to patients how doctors select their treatment. Unfortunately, when the available treatment options are similar to one another, this approach has the potential to inadvertently undermine both clinical research and clinical care. Hence, it is important to assess whether, in the context of similar treatment options, individuals support current practice of using very different disclosure practices in research and care.

METHODS

Respondents were randomly presented with either (1) a "drug" scenario involving two medications for hypertension (called CTD and TRT) whose risk-benefit profiles are very similar, or (2) a "dose timing" scenario involving morning versus nighttime dosing of the same antihypertensive. Respondents were asked whether, in the presented scenario, they agree, using a 7-point scale (1 = strongly disagree, 4 = neutral, 7 = strongly agree), that it is important to disclose to potential research subjects that whether they receive CTD or TRT/AM or PM dosing will be determined by randomization. Respondents were also asked whether they agree, using the same 7-point scale, that it is important to disclose to patients who face the same treatment options how their doctor will decide whether they receive CTD or TRT/AM or PM dosing.

RESULTS

The survey was sent to 3330 online GfK KnowledgePanel members and completed by 2130 (response rate, 64.0%). Respondents indicated that it is somewhat important to disclose to potential subjects that whether they receive CTD or TRT/AM or PM dosing will be determined by randomization (mean, 5.10 [95% CI, 5.02 to 5.17]). Respondents also indicated that it is slightly more important to disclose to patients who face the same treatment options how the doctor will decide whether they receive CTD or TRT/AM or PM dosing (mean, 5.29 [95% CI, 5.22 to 5.36]; p < .001). In addition, 66.4% indicated that, in the setting of similar options, it is equally important to disclose how treatment is selected in research and care, 20.5% indicated it is more important to disclose this information in clinical care, and 13.1% indicated it is more important to disclose it in research.

CONCLUSION

When the available options are similar to each other, individuals do not support current practice and policies that maintain that disclosure of how treatments are selected is very important in clinical research but not important in clinical care. Future research will be needed to evaluate the feasibility of developing disclosure practices and policies for this context that are consistent with individuals' views.