The research study, published in the journal PLoS One, suggests that diagnostic studies on TB, malaria and HIV commercial tests had moderate to low quality and were often poorly reported.
Worldwide, TB, malaria and HIV/AIDS are responsible for approximately 3.5 million deaths annually. Early diagnosis is a vital part of controlling the spread of these diseases. However, questions have been raised in the scientific literature about the performance of these tests.
The new study suggests many of these scientific papers use poor methodologies and lack quality. Moreover sources of bias and variation were present in all the studies. “The necessary methodological elements such as patient selection criteria, recruitment methods or blinded test interpretation were poorly reported,” said Dr. Pai, who is also the senior author and principal investigator of the study. “Moreover, only a small percentage of these studies accurately described the manner in which the tests were conducted and whether they are reproducible.”
“Poorly designed studies can lead to premature or misguided adoption of tests that may have little or no clinical and public health relevance, resulting in incorrect diagnosis and adverse consequences for the patient,” said Dr. Pai.
The challenge facing the researchers is to make a concerted effort to improve the quality of diagnostic studies during design and implementation. “Whether it is for cancer testing, TB or even the flu, we must report the study results in a clear and transparent manner in order to validate the accuracy of the test and ensure it is properly used at the clinical level,” stated Dr. Pai.
*TDR: Special Programme for Research and Training in Tropical Diseases (TDR)
** WHO: World Health Organization
Dr. Madhukar Pai is a researcher in the Respiratory Epidemiology & Clinical Research Unit at the Montreal Chest Institute and RI – MUHC. He is also an assistant professor of epidemiology at McGill University.
Dr. Patricia Fontela, first author of the study, is a pediatric critical care specialist and research fellow under the supervision of Dr. Caroline Quach at the Montreal Children’s Hospital, RI MUHC. She is the recipient of MCH Fellowship funding and doing her studies in epidemiology, McGill University.
This article was co-authored by Dr. Nitika Pant Pai, Mr Ian Schiller and Dr. Nandini Dendukuri, Division of Clinical Epidemiology, Department of Medicine, McGill University and Dr. Andrew Ramsay from TDR and World Health Organization (WHO), Switzerland.
This study was funded by the Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization (WHO), Switzerland, and the Canadian Institutes for Health Research (CIHR).
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