Dr. Simon Hatcher
Last week BEACON finally submitted all our documentation to Clinical Trials Ontario to start their ethical review. As part of this, we had to consider the issue of participant burden in the cohort study. This was not unexpected as in a large multi-centre trial with multiple investigators, everyone has their own favourite rating scale or hypothesis that they want tested. The final list of rating scales and procedures would have resulted in an initial research interview lasting at least 90 minutes – and you have to remember that in the first appointment the participants are also introduced to the smartphone app and have their first clinical appointment. This could mean that participants have to give up about half a day for their first appointment. In my view, this is clearly too much – especially for people recruited in crisis. In the end, we have been able to decrease the number of rating scales that participants are asked to complete on the basis that we would only choose ones which were clinically relevant and you would be able to feasibly do in a regular outpatient clinic.
But it did get me thinking about what is too much participant burden? And, of course, there is research literature on this and even a rating scale which measures perceived participant burden in research – the PERBA or Perceived Research Burden Assessment (Lingler et al. 2014)[i]. This is a 17-item scale that assesses three components of participant burden: psychological, logistical and physical. It asks such questions as, are the assessments too intrusive or there are too many questions; whether the study site is convenient to get to; or whether participants think they will be harmed by the research. Clearly, the number of rating scales you are asked to complete is only part of assessing participant burden and burden shouldn’t be restricted to just the potential direct risks of taking part in research. The PeRBA is designed to be used, for example, to test hypotheses about decision making in choosing to drop out of clinical trials. However, when investigating decision making, the burden of taking part in the research needs to be weighed against the possible benefits. One thing to consider is whether we also need a perceived research benefits assessment scale.
The issues here are very similar to those raised by the idea of treatment burden in the clinical world, which has been defined as “self-care practices that patients with chronic illness must perform to respond to the requirements of their healthcare providers, as well as the impact that these practices have on patient functioning and well-being. Increasing levels of treatment burden may lead to suboptimal adherence and negative outcomes” (Gallacher et al. 2013)[ii]. This is an under investigated area that is now being driven by the emphasis on patient-centered care (rather than provider-centered care) and the realization that many things we have insisted on for patients, such as strict glucose control in diabetes, are not as important as they used to be.
Hopefully, in BEACON, potential participants will feel that the benefits outweigh the burdens. Follow us for developments.
[i] Lingler JH, Schmidt K, Gentry A, Hu L, Terhost L. Perceived Research Burden Assessment (PeRBA): Instrument Development and Psychometric Evaluation. J Empir Res Hum Res Ethics. 2014 Oct; 9(4): 46-49.
[ii] Gallacher K, Jani B, Morrison D, MacDonald S, Blane D, Erwin P, May CR, Montori VM, Eton DT, Smith F, Batty DG, Mair FS. Qualitative Systematic Reviews of Treatment Burden in Stroke, Heart Failure, and Diabetes – Methodological Challenges and Solutions. BMC Med Res Meth. 2013; 13(10): DOI: 10.1186/1471-2288-13-10