Dr. Madhukar Pai (MD, PhD) is an associate professor at McGill University in Montreal and an Associate Director of the McGill International TB Centre. His research is mainly focused on improving the diagnosis of tuberculosis, especially in high-burden countries. His work is supported by grant funding from the Bill & Melinda Gates Foundation, Grand Challenges Canada and the Canadian Institutes of Health Research.
March 24th is World Tuberculosis (TB) Day, and a good time to take stock of global TB control. Sadly, despite the progress made, an estimated 8.6 million people developed TB in 2012, and 1.3 million died because of the disease. India alone accounted for 25% of this global TB burden.
The WHO Global TB Report 2013 emphasized two major challenges for controlling the TB epidemic. First, of the estimated 8.6 million cases, nearly 3 million cases were ‘missing’, either because they were not diagnosed or not notified by health systems; second, the growing crisis of multi-drug-resistant TB (MDR-TB), where three out of four cases with MDR-TB are still not being diagnosed and treated.
India accounts for a third of the so-called ‘missing 3 million’ cases and India is also doing poorly with diagnosing and treating MDR-TB. Of the estimated 64,000 cases of MDR-TB among notified cases in 2012, only 17,373 cases were diagnosed under the Revised National TB Control Programme (RNTCP). While some of the missing cases in India may be completely undiagnosed, it is likely that a large number sought care in the informal and private sectors, but never got notified.
Most Indians seek private health care. Studies suggest that TB patients often begin seeking care in the informal private sector (pharmacists and unqualified practitioners), then seek care from qualified practitioners, and eventually end up in the RNTCP for free treatment. TB is diagnosed in India after a delay of about 2 months, and three providers are seen before patients are finally diagnosed and put on TB treatment. Prescription studies show the widespread use of irrational drug regimens. Diagnostic practices in the private sector remain suboptimal and heavily reliant on unreliable blood tests for TB.
Thus, the quality of TB care in India is a major concern and poorly managed TB may be a big driver of drug resistance in the country. Despite this, there is currently no program to systematically evaluate the quality of care, including the accuracy of diagnoses and/or treatment efficacy among Indian healthcare providers. For instance, there is currently no information on what happens when, say, a person with a two-week history of cough goes to a healthcare provider in India; neither do we know how the quality of care varies across public versus private clinics, and unqualified versus qualified providers.
The RNTCP recently announced “universal access to quality diagnosis and treatment for all tuberculosis patients in the community” as its goal in the new National Strategic Plan. Recognizing the need to leverage the private sector in developing a solution, the plan includes engagement of the private sector using “Private Provider Interface Agencies” (PPIA) to enlist, sensitize, incentivize, and monitor diagnosis and treatment by private providers, to provide patient cost offsets such as subsidized diagnostics and free drugs to privately treated patients, and improve case notifications to the RNTCP.
To test the PPIA model, several partners (including the Bill & Melinda Gates Foundation) are currently implementing PPIA pilot projects in Mumbai and Patna to generate evidence for scale-up. It is in this context that we proposed the use of standardized patients (mystery clients) to assess the quality of TB care in India, nested within the PPIA pilots in Mumbai and Patna.
Thanks to the support of funders like Grand Challenges Canada (funded by the Government of Canada) and the Bill & Melinda Gates Foundation, who value high-risk, innovative approaches, the quality of care surveillance system that we are developing will be the first such program for measuring and improving the quality of TB care.
Standardized patients are actors trained to present a consistent case of illness to health providers. Unlike prescription audits and hypothetical vignettes, which measure clinical knowledge and competence, the mystery client approach has been shown to accurately assess provider practice. This is important, since clinical practice can differ substantially from knowledge or competence.
The standardized patient method was recently used in India by Jishnu Das and colleagues to examine quality of care for angina, asthma and dysentery. The study found low levels of medical training. Correct diagnoses were rare and incorrect treatments were widely prescribed. If such findings also apply to TB care, it would dramatically change common perceptions of the underlying systemic issues in the management of TB, and would influence policies.
Although regarded as the gold standard, until now, standardized patients have never been used to assess TB care. We were pleased, therefore, that our proposal (with Jishnu Das as co-PI) to do this was successful in Round 5 of the Stars in Global Health competition. Using the Phase 1 grant, we have already begun a pilot study in New Delhi to assess the validity of using mystery patients for assessing TB care among qualified and informal providers (including chemists). Based on the results of the pilot (which are expected by fall), we hope to expand the study to assess the quality of TB care in Mumbai and Patna, as part of the PPIA interventions in these cities. This expansion will be supported by the Bill & Melinda Gates Foundation and conducted in partnership with the Institute for Social and Economic Research on Development and Democracy (ISERDD).
Successfully implemented, the use of standardized patients could lead to significant improvements in quality of care in a country where nearly 1,000 people die of TB every day.
For an overview of all our TB-related projects, read our blog post ‘Canadian-supported innovations fighting tuberculosis in low- and middle-income countries‘. Join the conversation on Twitter by using hashtag #WorldTBday. We encourage you to post your questions and comments about this blog post on our Facebook page Grand Challenges Canada and on Twitter @gchallenges