Lies in clinical trials – the truth about data accuracy

Misreporting of product adherence in the MTN-003/VOICE trial for HIV prevention in Africa: participants' explanations for dishonesty.

Montgomery ET, Mensch B, Musara P, Hartmann M, Woeber K, Etima J, van der Straten. AIDS Behav. 2016 Nov 17. [Epub ahead of print]

Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors circulating in clinic waiting-rooms and surrounding communities. Prevailing power hierarchies between staff and participants may exacerbate misreporting. Participants recognized and suggested that objective, real-time feedback is needed to encourage honest reporting.

Abstract access  

Editor’s notes: The authors of this insightful paper set out the reasons women gave in a trial of vaginal and oral programmes for inaccurately reporting their behaviour during the trial.  The authors could conduct this study because biologic/pharmacokinetic data were available which showed evidence of product use. These data were shared with individual women. None of the reasons women gave for not telling the truth is surprising. They lied to avoid additional questioning from research staff.  They feared telling the truth would result in being removed from the trial. They feared beingreprimanded. Overall, not telling the truth about product use helped them save face and time. The findings do highlight the power difference between researchers and researched, something that is hard to avoid in many areas of research. This difference was exacerbated in some circumstances by the (reported) harsh behaviour of staff towards women. The ease with which women could manipulate pill counts or product use checks, by discarding unused product is also not surprising.  The perception by some women that the researchers had lied, because of changes in the trial part way through, is important to note. This highlights the importance of clear information when a trial is explained as it begins. It also points to the importance of continuous explanations and checking participant understanding. It cannot be assumed that there is a shared understanding between researcher and researched. This is something that is easily overlooked as a trial progresses and routine visits are established. The authors highlight the value of objective measures on product use.  They also observe that some participants suggested objective, real-time feedback, during trials.  However, the authors also note that for many women lying about aspects of their lives to partners and family, was a way of managing their lives. It could be that ‘real time feedback’ would act as a deterrent to participation for some in such circumstances.  No system of data collection is perfect.  It is, however, very useful to have a timely reminder that no interview data, however collected, can be assumed to be wholly accurate.    

Africa
South Africa, Uganda, Zimbabwe
  • share