Shalowitz DI, Miller FG.
Communicating the results of clinical research to participants: attitudes, practices, and future directions.
PLoS Med. 2008 May 13;5(5):e91.
PubMed.
“Participation in medical research" really means participating in a clinical trial—either as a specific subject or as the caregiver of someone who enrolls in a clinical trial. We know that patients who take part in trials—certainly in psychiatry and neurology—do better than patients who aren't involved in trials, even if they are randomized to receive placebo. This is presumably because of placebo effects (which are real and measurable and formed the basis of much of the apparent efficacy of medical treatments available until 50 years ago) and a positive effect of the attention received during assessments and more general effects associated with the hope and feeling of purpose engendered by participation. Knowing the results of the trial—both in terms of personal individual response and that of the whole group—is an important part of this, too.
Having said this, there are often reasons why it is difficult to give information about the outcome of a trial until several months have passed following an individual participant's involvement. This may be part of the trial design to protect against unblinding or due to the delays involved in completing data collection, cleaning, and analyzing the data before a final analysis can reveal the results. My own experience is that the people with dementia and their caregivers who have participated in our large-scale trials have been very understanding about the limitations that are placed upon us by these factors and are positive about waiting for the results to be made available so long as they understand that we will let them know the final results as soon as we have them.
A theme that arises again and again in the UK—sadly, in my view—is that clinicians are often reluctant to put their patients forward for trials—despite the clear benefits that I have alluded to above. This arises, I believe, from a mixture of not wanting to be bothered with the perceived extra workload that may be cascaded down to a physician whose patient enters a trial and in some cases a feeling that vulnerable patients need to be protected from having their established treatment disrupted in a way that will offer little benefit and potential risk. I think that researchers like myself have a job to do in persuading our colleagues to change their attitudes and behavior in this area!
Comments
King's College London
“Participation in medical research" really means participating in a clinical trial—either as a specific subject or as the caregiver of someone who enrolls in a clinical trial. We know that patients who take part in trials—certainly in psychiatry and neurology—do better than patients who aren't involved in trials, even if they are randomized to receive placebo. This is presumably because of placebo effects (which are real and measurable and formed the basis of much of the apparent efficacy of medical treatments available until 50 years ago) and a positive effect of the attention received during assessments and more general effects associated with the hope and feeling of purpose engendered by participation. Knowing the results of the trial—both in terms of personal individual response and that of the whole group—is an important part of this, too.
Having said this, there are often reasons why it is difficult to give information about the outcome of a trial until several months have passed following an individual participant's involvement. This may be part of the trial design to protect against unblinding or due to the delays involved in completing data collection, cleaning, and analyzing the data before a final analysis can reveal the results. My own experience is that the people with dementia and their caregivers who have participated in our large-scale trials have been very understanding about the limitations that are placed upon us by these factors and are positive about waiting for the results to be made available so long as they understand that we will let them know the final results as soon as we have them.
A theme that arises again and again in the UK—sadly, in my view—is that clinicians are often reluctant to put their patients forward for trials—despite the clear benefits that I have alluded to above. This arises, I believe, from a mixture of not wanting to be bothered with the perceived extra workload that may be cascaded down to a physician whose patient enters a trial and in some cases a feeling that vulnerable patients need to be protected from having their established treatment disrupted in a way that will offer little benefit and potential risk. I think that researchers like myself have a job to do in persuading our colleagues to change their attitudes and behavior in this area!
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