PROF. MADHUKAR PAI, MD, PHDCANADA 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

I am presenting on behalf of the QuTUB team

Jishnu Das, World Bank Veena Das, Hopkins Srinath S, McGill

Ada KwanBen DanielsSofi BergkvistAndy McDowellCaroline VadnaisISERDD team in IndiaPATH, IndiaWorld Health Partners, India

Funding:

Puneet Dewan, BMGF

1 in 4 TB patients live in India1 in 8 TB patients are managed in the Indian private sector

Several signs that quality of TB care is a concern

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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

47 studies, measuring knowledge or self-reported practices

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

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

Growing use of the SP method

Ethical clearance from McGill and ISERDD

Informed consents obtained from all providers before the study

Pilot training and fieldwork - March through May 2014

Pilot objectives1. 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

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

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”)

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

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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)

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Correct case management Case # Case description Case was designed to assess

quality of care for a person whoExpected correct case management

SP1 Classic 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

SP2 Classic 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

SP3 Chronic 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)

SP4 Chronic 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

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

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)

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

Results: major outcomes for each SP case

Das J et al. Lancet Infect Dis In Press

12 – 38% were correctly managed

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 Unlabelled5 Antibiotic

3 Anti-Allergy

3 Diagnosed Other Illnesses:

Typhoid, Allergy, "Weakness"

4 Diagnosed Tuberculosis

4 Gave Non-TB Drugs:2 Unlabelled2 Antibiotic

2 Anti-Allergy

7 CXR 2 CXR + Sputum

8 CXR + Mantoux Test

1 CXR + GeneXpert

4 Gave TB Drugs 8 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)

Impact of provider qualifications on main standardized patient outcomes

Favors MBBSFavors Non-MBBS

Das J et al. Lancet Infect Dis In Press

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

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

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