1. PROF. MADHUKAR PAI, MD, PHD CANADA RESEARCH CHAIR IN TRANSLATIONAL EPIDEMIOLOGY & GLOBAL HEALTH DIRECTOR, MCGILL GLOBAL HEALTH PROGRAMS ASSOCIATE DIRECTOR, MCGILL INTERNATIONAL TB CENTRE Quality of TB care in India: first use of standardized patients

2. I am presenting on behalf of the QuTUB team Jishnu Das, World BankVeena Das, HopkinsSrinath S, McGill Ada Kwan Ben Daniels Sofi Bergkvist Andy McDowell Caroline Vadnais ISERDD team in India PATH, India World Health Partners, India Funding: Puneet Dewan, BMGF

3. 1 in 4 TB patients live in India 1 in 8 TB patients are managed in the Indian private sector

4. Several signs that quality of TB care is a concern

5. 5

6. An average TB patient in India is diagnosed with TB after a delay of 2 months, and is seen by 3 healthcare providers before diagnosis

7. 47 studies, measuring knowledge or self-reported practices

8. Only half of the health care providers were aware of the importance of suspecting TB in persons with cough of more than 2-3 weeks duration

9. Only a third of the providers were aware of the correct regimen for TB.

10. Growing use of the SP method

11. Ethical clearance from McGill and ISERDD Informed consents obtained from all providers before the study Pilot training and fieldwork - March through May 2014 Pilot objectives 1.Validate the SP methodology for TB ◦Detection rate ◦Adverse events for providers and standardized patients 2.Obtain TB quality of care measures for SP cases ◦Consultation time, consultation fees, adherence to checklist 3.Measure the know-do gap among providers ◦Practice (via SP methodology) vs. Knowledge (via provider vignettes) Das J et al. Lancet Infect Dis In Press

12. SP1: Classic case of suspected TB (2-3 weeks of productive cough, fever, weight loss – “TB suspect - naive”)

13. SP2: Classic case of suspected TB who has already taken antibiotics (2-3 weeks of cough/fever, and has taken amoxicillin for a week – “TB suspect after antibiotics”) +

14. SP3: Chronic, productive cough (for 1 month) with 2+ positive smear result from the public sector (“TB case”) +

15. SP4: Chronic, productive cough with previous history of incomplete TB treatment, and currently having a positive smear result from the public sector (possible MDR-TB) ++

16. Correct case management Case #Case descriptionCase was designed to assess quality of care for a person who Expected correct case management SP1Classic case of presumed TB with 2-3 weeks of cough and fever Presents with presumptive TB, for the first time, to a private healthcare provider Recommendation for sputum testing or chest X-ray or referral to a public DOTS center/qualified provider SP2Classic case of presumed TB who has had 2-3 weeks of cough and fever and a history of 1 week of broad-spectrum antibiotic (amoxicillin) treatment by another provider, with no improvement Presents after an initial, failed (empiric) treatment with broad- spectrum antibiotics Recommendation for sputum testing or chest X-ray or referral to a public DOTS center/qualified provider SP3Chronic cough with positive sputum smear report for TB from a public health facility Presents with evidence of microbiologically confirmed TB Either referral to a public DOTS center, a qualified private provider, or specialist or (in the case of a qualified private provider) initiation of treatment with standard, 4-drug first-line anti-TB therapy (HRZE regimen: isoniazid [INH], rifampicin, pyrazinamide, and ethambutol) SP4Chronic cough and a positive sputum smear report from a public health facility, and, if asked, history of previous, incomplete TB treatment, which would raise the suspicion of multidrug-resistant TB (MDR-TB). Presents as a previously treated TB patient with recurrence of TB (i.e. suspicion of drug-resistance) Recommendation for any drug- susceptibility test (culture/DST, line probe assay or Xpert MTB/RIF) or referral to a public DOTS center

17. Provider sample: ◦100 providers received SP cases for a total of 250 SP interactions ◦29% had MBBS degree (qualified) ◦40% held degrees in alternative systems of medicine ◦31% were informal providers ◦Providers not randomly selected; they had to consent All SPs debriefed immediately; they also had MP3 recorders Delhi pilot training and fieldwork

18. Tons of meds! (antibiotics, anti-pyretics, cough syrups, bronchodilators, vitamins, anti-histaminics, steroids…): So, we used a greatly simplified coding approach for the pilot Jishnu Das, Veena Das, Madhukar Pai et al. Unpublished data (Confidential) ~50% of patients received loose/unlabelled pills (so, coding was a challenge)

19. Detection rate ◦5% of all SP interactions were detected by care providers Adverse events for providers and standardized patients ◦None of the SPs had any threats to their safety ◦No providers reported any adverse effects (detection survey) ◦No added inconveniences to the providers or other patients ◦SPs paid normal fees and were trained to step aside in emergencies ◦SP consultation lasted 6 minutes (average) Results: Areas for SP methodology validation Das J et al. Lancet Infect Dis In Press

20. Results: major outcomes for each SP case Das J et al. Lancet Infect Dis In Press 12 – 38% were correctly managed

21. Individual pathways to diagnosis and treatment were complex Das J et al. Lancet Infect Dis In Press 50 SP4 interactions 42 asked to see sputum report 30 did not treat or refer 12 did not test 5 Gave Non-TB Drugs: 5 Unlabelled 5 Antibiotic 3 Anti-Allergy 3 Diagnosed Other Illnesses: Typhoid, Allergy, "Weakness" 4 Diagnosed Tuberculosis 4 Gave Non-TB Drugs: 2 Unlabelled 2 Antibiotic 2 Anti-Allergy 7 CXR2 CXR + Sputum 8 CXR + Mantoux Test 1 CXR + GeneXpert 4 Gave TB Drugs8 Referred 8 did not ask to see sputum report 2 Referred 1 CXR 1 CXR + Sputum 4 Non-TB Drugs (Antibiotics, Anti- Allergy, Cough Syrups)

22. Impact of provider qualifications on main standardized patient outcomes Favors MBBS Favors Non-MBBS Das J et al. Lancet Infect Dis In Press

23. Know-do gap In the vignette, 73% ordered a CXR or sputum test for a presumptive TB case Das J et al. Lancet Infect Dis In Press In practice (SPs), only 10% ordered CXR or sputum test

24. Conclusions The SP methodology can be successfully implemented to assess quality of TB care. Our data, although not from a random sample, suggest low adherence of providers to established standards of TB care in clinical practice despite higher markedly higher levels of knowledge. ◦Early diagnosis of TB in the private sector is a huge challenge. ◦Informal providers do not seem to use TB drugs, but they contribute to diagnostic delays. ◦Formal providers do not prefer to refer, and might contribute to MDR generation. We are now confirming these results with larger SP studies in Patna and Mumbai, as part of the MLE for the BMGF-funded PPIA projects

25. Limitations of the SP methodology No single case captures the spectrum/complexity of TB Our SPs did not have physical signs (e.g. crackles) that could be identified by chest auscultation, and providers may have been misled by the lack of physical findings among our SPs The SP methodology works well with one-time and new patient interactions, as opposed to multiple visits to the same provider, or for patients who are already known to the doctor. Unlabelled (loose) pills could not be identified This methodology cannot capture important outcomes such as adherence to TB treatment, case notification