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Scientific title: Strategies for optimizing the accurate elicitation of patient-reported data relating to drug safety
What did we know before this research?
During clinical trials, research teams use various information that participants tell them. These include the occurrence of new, possibly harmful or unpredicted side effects (known as adverse events or adverse drug reactions), the patients’ medical history and which other medicines they are taking.
Researchers are concerned that the way participants are questioned can influence what information they report, and therefore prevent an accurate assessment of the safety of the drugs used in clinical trials. However, the current scientific literature doesn't include a standard method to best carry out the questioning or how the information is then assessed.
What does this study add?
We nested a study within the SEACAT and InterACT trials to investigate different ways of questioning trial participants about their health and use of other medications in antimalarial trials.
The questioning methods and the different trial contexts did appear to influence the collection of these important contributions to drug safety assessments. Consequently, there should be further work to investigate these influences and find appropriate questioning methods.
To contribute to this topic further we conducted an online global survey of malaria researchers about the ways they question their participants about this information, and assess the results. The survey showed that various methods are being used, which could influence trial results. The best way for obtaining safety information from participants is unclear, therefore we propose that anti-malarial clinical researchers work towards consensus about the design of optimal methods.
This study also conducts a consensus-building process called a Delphi about these issues. This will be supported with results from a Cochrane systematic review of work in other diseases where different ways of questioning participants have been compared.
The research team
Prof. Karen Barnes, University of Cape Town, South Africa
Ms Elizabeth Allen, University of Cape Town, South Africa
Dr Lasse Vestergaard, Centre for International Health and Development, University of Copenhagen, Denmark
Dr Martha Lemnge, National Institute for Medical Research, Tanga, Tanzania
Dr Sarah Staedke, London School of Hygiene and Tropical Medicine, UK
Dr Clare Chandler, London School of Hygiene and Tropical Medicine, UK
Dr Ushma Mehta, Pharmacovigilance Consultant, Johannesburg
Dr Ola Persson, Centre for International Health and Development, University of Copenhagen, Denmark
Dr N Nyagonde, InterACT, Clinician, Muheza, Tanzania
Ms Cheryl Pace, Liverpool School of Tropical Medicine, UK
Latest on this research
This project found that different ways of questioning trial participants about their health and use of other medications influenced the collection of important drug safety information. The trial context also appears to be important.
In a paper published in BMC Medical Research Methodology we suggest there should be further work to investigate these influences and find appropriate questioning methods within antimalarial drug trials.
Our online global survey of malaria researchers about the ways their participants are typically questioned, and how reports are assessed, showed that various methods are being used. A paper published in the Malari Journal suggested that these differences could influence trial results.
A Cochrane systematic review and a Delphi consensus study about these issues are ongoing.