A rapid and accurate diagnosis is the first step towards treatment in the fight against infectious disease. However, a team headed by Dr. Madhukar Pai at the Research Institute of the McGill University Health Centre (RI-MUHC) and McGill University in collaboration with researchers at the TDR* and the WHO*, has highlighted the poor quality of published studies that evaluate the accuracy of diagnostic tests for 3 major killer infectious diseases (TB, HIV/AIDS and malaria). 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).
The McGill University Health Centre (MUHC) is a comprehensive academic health institution with an international reputation for excellence in clinical programs, research and teaching. Its partner hospitals are the Montreal Children's Hospital, the Montreal General Hospital, the Royal Victoria Hospital, the Montreal Neurological Hospital, the Montreal Chest Institute and the Lachine Hospital. The goal of the MUHC is to provide patient care based on the most advanced knowledge in the health care field and to contribute to the development of new knowledge. www.muhc.ca
The Research Institute of the McGill University Health Centre (RI MUHC) is a world-renowned biomedical and health-care hospital research centre. Located in Montreal, Quebec, the institute is the research arm of the MUHC, the university health center affiliated with the Faculty of Medicine at McGill University. The institute supports over 600 researchers, nearly 1200 graduate and post-doctoral students and operates more than 300 laboratories devoted to a broad spectrum of fundamental and clinical research. The Research Institute operates at the forefront of knowledge, innovation and technology and is inextricably linked to the clinical programs of the MUHC, ensuring that patients benefit directly from the latest research-based knowledge.
The Research Institute of the MUHC is supported in part by the Fonds de la recherche en santé du Québec. For further details visit: www.muhc.ca/research
About the MUHC Redevelopment Project Guided by its mission and its role as co-leaders of the McGill integrated university hospital network, the MUHC is carrying out a $2.2-billion Redevelopment Project that will help the Government achieve its vision for academic medicine in Quebec. Excellence in patient care, research, education and technology assessment will be fostered on three state-of-the-art campuses—The Mountain, the Glen and Lachine—and through strong relationships with healthcare partners. Each LEED®-registered campus will be designed to provide patients and their families with “The Best Care for Life” in a healing environment that is anchored in best sustainable development practices, including BOMA BESt guidelines. www.muhc.ca/construction
For more information please contact:
Communications Coordinator (research)
Public Affairs & Strategic Planning
(514) 843 1560 julie.robert [at] muhc.mcgill.ca" target="_blank">
julie.robert [at] muhc.mcgill.ca