Quality of TB care in India using mystery patients

@article{Sassi2024,

title = {Impact of the COVID-19 pandemic on quality of tuberculosis care in private facilities in Bandung, Indonesia: a repeated cross-sectional standardized patients study},

author = {Angelina Sassi and Bony Wiem Lestari and Kuuni Ulfah Naila El Muna and Charity Oga-Omenka and Nur Afifah and Rodiah Widarna and Lavanya Huria and Nathaly Aguilera Vasquez and Andrea Benedetti and Panji Fortuna Hadisoemarto and Benjamin Daniels and Jishnu Das and Madhukar Pai and Bachti Alisjahbana},

url = {https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-023-17001-y.pdf},

year  = {2024},

date = {2024-01-05},

urldate = {2024-01-01},

journal = {BMC Public Health},

volume = {24},

number = {1},

pages = {1–18},

publisher = {BioMed Central},

abstract = {Background

Indonesia has the second highest incidence of tuberculosis in the world. While 74% of people with tuberculosis in Indonesia first accessed the private health sector when seeking care for their symptoms, only 18% of tuberculosis notifications originate in the private sector. Little is known about the impact of the COVID-19 pandemic on the private sector. Using unannounced standardized patient visits to private providers, we aimed to measure quality of tuberculosis care during the COVID-19 pandemic.



Methods

A cross-sectional study was conducted using standardized patients in Bandung City, West Java, Indonesia. Ten standardized patients completed 292 visits with private providers between 9 July 2021 and 21 January 2022, wherein standardized patients presented a presumptive tuberculosis case. Results were compared to standardized patients surveys conducted in the same geographical area before the onset of COVID-19.



Results

Overall, 35% (95% confidence interval (CI): 29.2–40.4%) of visits were managed correctly according to national tuberculosis guidelines. There were no significant differences in the clinical management of presumptive tuberculosis patients before and during the COVID-19 pandemic, apart from an increase in temperature checks (adjusted odds ratio (aOR): 8.05, 95% CI: 2.96–21.9, p < 0.001) and a decrease in throat examinations (aOR 0.16, 95% CI: 0.06–0.41, p = 0.002) conducted during the pandemic.



Conclusions

Results indicate that providers successfully identify tuberculosis in their patients yet do not manage them according to national guidelines. There were no major changes found in quality of tuberculosis care due to the COVID-19 pandemic. As tuberculosis notifications have declined in Indonesia due to the COVID-19 pandemic, there remains an urgent need to increase private provider engagement in Indonesia and improve quality of care.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Huria2024,

title = {Care pathways of individuals with tuberculosis before and during the COVID-19 pandemic in Bandung, Indonesia},

author = {Lavanya Huria and Bony Wiem Lestari and Eka Saptiningrum and Auliya Ramanda Fikri and Charity Oga-Omenka and Mohammad Abdullah Heel Kafi and Benjamin Daniels and Nathaly Aguilera Vasquez and Angelina Sassi and Jishnu Das and Ira Dewi Jani and Madhukar Pai and Bachti Alisjahbana},

url = {https://journals.plos.org/globalpublichealth/article/file?id=10.1371/journal.pgph.0002251&type=printable},

year  = {2024},

date = {2024-01-02},

urldate = {2024-01-01},

journal = {PLOS Global Public Health},

volume = {4},

number = {1},

pages = {e0002251},

publisher = {Public Library of Science San Francisco, CA USA},

abstract = {The COVID-19 pandemic is thought to have undone years’ worth of progress in the fight against tuberculosis (TB). For instance, in Indonesia, a high TB burden country, TB case notifications decreased by 14% and treatment coverage decreased by 47% during COVID-19. We sought to better understand the impact of COVID-19 on TB case detection using two cross-sectional surveys conducted before (2018) and after the onset of the pandemic (2021). These surveys allowed us to quantify the delays that individuals with TB who eventually received treatment at private providers faced while trying to access care for their illness, their journey to obtain a diagnosis, the encounters individuals had with healthcare providers before a TB diagnosis, and the factors associated with patient delay and the total number of provider encounters. We found some worsening of care seeking pathways on multiple dimensions. Median patient delay increased from 28 days (IQR: 10, 31) to 32 days (IQR: 14, 90) and the median number of encounters increased from 5 (IQR: 4, 8) to 7 (IQR: 5, 10), but doctor and treatment delays remained relatively unchanged. Employed individuals experienced shorter delays compared to unemployed individuals (adjusted medians: -20.13, CI -39.14, -1.12) while individuals whose initial consult was in the private hospitals experienced less encounters compared to those visiting public providers, private primary care providers, and informal providers (-4.29 encounters, CI -6.76, -1.81). Patients who visited the healthcare providers >6 times experienced longer total delay compared to those with less than 6 visits (adjusted medians: 59.40, 95% CI: 35.04, 83.77). Our findings suggest the need to ramp up awareness programs to reduce patient delay and strengthen private provide engagement in the country, particularly in the primary care sector.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Saria2023,

title = {The family doctor: health, kin testing and primary care in Patna, India},

author = {Vaibhav Saria and Veena Das and Benjamin Daniels and Madhukar Pai and Jishnu Das},

url = {https://www.qutubproject.org/wp-content/uploads/2017/09/2023-10-Saria-AM.pdf},

year  = {2023},

date = {2023-10-13},

journal = {Anthropology & Medicine},

abstract = {Private primary care providers are usually the first site where afflictions come under institutional view. In the context of poverty, the relationship between illness and care is more complex than a simple division of responsibilities between various actors—with care given by kin, and diagnosis and treatment being the purview of providers. Since patients would often visit the provider with family members, providers are attuned to the patients’ web of kinship. Providers would take patients’ kinship arrangements into account when prescribing diagnostic tests and treatments. This paper terms this aspect of the clinical encounter as ‘kin testing’ to refer to situations/clinical encounters when providers take into consideration that care provided by kin was conditional. ‘Kin testing’ allowed providers to manage the episode of illness that had brought the patient to the clinic by relying on clinical judgment rather than confirmed laboratory tests. Furthermore, since complaints of poor health also were an idiom to communicate kin neglect, providers had to also discern how to negotiate diagnoses and treatments. Kinship determined whether the afflicted bodies brought to the clinics were diagnosed, whether medicines reached the body, and adherence maintained. The providers’ actions make visible the difference that kinship made in how health is imagined in the clinic and in standardized protocols. Focusing on primary care clinics in Patna, India, we contribute to research that shows that kinship determines care and management of illnesses at home by showing that relatedness of patients gets folded in the clinic by providers as well.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{svadzian2023use,

title = {Use of standardised patients to assess tuberculosis case management by private pharmacies in Patna, India: A repeat cross-sectional study},

author = {Anita Svadzian and Benjamin Daniels and Giorgia Sulis and Jishnu Das and Amrita Daftary and Ada Kwan and Veena Das and Ranendra Das and Madhukar Pai},

url = {https://journals.plos.org/globalpublichealth/article/file?id=10.1371/journal.pgph.0001898&type=printable},

year  = {2023},

date = {2023-05-26},

urldate = {2023-01-01},

journal = {PLoS Global Public Health},

volume = {3},

number = {5},

pages = {e0001898},

publisher = {Public Library of Science San Francisco, CA USA},

abstract = {As the first point of care for many healthcare seekers, private pharmacies play an important role in tuberculosis (TB) care. However, previous studies in India have showed that private pharmacies commonly dispense symptomatic treatments and broad-spectrum antibiotics over-the-counter (OTC), rather than referring patients for TB testing. Such inappropriate management by pharmacies can delaye TB diagnosis. We assessed medical advice and OTC drug dispensing practices of pharmacists for standardized patients presenting with classic symptoms of pulmonary TB (case 1) and for those with sputum smear positive pulmonary TB (case 2), and examined how practices have changed over time in an urban Indian site. We examined how and whether private pharmacies improved practices for TB in 2019 compared to a baseline study conducted in 2015 in the city of Patna, using the same survey sampling techniques and study staff. The proportion of patient-pharmacist interactions that resulted in correct or ideal management, as well as the proportion of interactions resulting in antibiotic, quinolone, and corticosteroid are presented, with standard errors clustered at the provider level. To assess the difference in case management and the use of drugs across the two cases by round, a difference in difference (DiD) model was employed. A total of 936 SP interactions were completed over both rounds of survey. Our results indicate that across both rounds of data collection, 331 of 936 (35%; 95% CI: 32–38%) of interactions were correctly managed. At baseline, 215 of 500 (43%; 95% CI: 39–47%) of interactions were correctly managed whereas 116 of 436 (27%; 95% CI: 23–31%) were correctly managed in the second round of data collection. Ideal management, where in addition to a referral, patients were not prescribed any potentially harmful medications, was seen in 275 of 936 (29%; 95% CI: 27–32%) of interactions overall, with 194 of 500 (39%; 95% CI: 35–43%) of interactions at baseline and 81 of 436 (19%; 95% CI: 15–22%) in round 2. No private pharmacy dispensed anti-TB medications without a prescription. On average, the difference in correct case management between case 1 vs. case 2 dropped by 20 percent points from baseline to the second round of data collection. Similarly, ideal case management decreased by 26 percentage points between rounds. This is in contrast with the dispensation of medicines, which had the opposite effect between rounds; the difference in dispensation of quinolones between case 1 and case 2 increased by 14 percentage points, as did corticosteroids by 9 percentage points, antibiotics by 25 percentage points and medicines generally by 30 percentage points. Our standardised patient study provides valuable insights into how private pharmacies in an Indian city changed their management of patients with TB symptoms or with confirmed TB over a 5-year period. We saw that overall, private pharmacy performance has weakened over time. However, no OTC dispensation of anti-TB medications occurred in either survey round. As the first point of contact for many care seekers, continued and sustained efforts to engage with Indian private pharmacies should be prioritized.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Daniels2023,

title = {Deception and informed consent in studies with incognito simulated standardized patients: empirical experiences and a case study from South Africa},

author = {Benjamin Daniels and Jody Boffa and Ada Kwan and Sizulu Moyo},

url = {https://journals.sagepub.com/doi/reader/10.1177/17470161231174734},

year  = {2023},

date = {2023-05-22},

urldate = {2023-01-01},

journal = {Research Ethics},

publisher = {SAGE Publications Sage UK: London, England},

abstract = {Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method’s increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Svadzian2023,

title = {Do Private Providers Initiate Anti-Tuberculosis Therapy on the Basis of Chest Radiographs? A Standardised Patient Study in Urban India},

author = {Anita Svadzian and Benjamin Daniels and Giorgia Sulis and Jishnu Das and Amrita Daftary and Ada Kwan and Veena Das and Ranendra Das and Madhukar Pai},

url = {https://www.sciencedirect.com/science/article/pii/S2772368223000124/pdfft?md5=5d54dfb026b5a8122933861e9ae3dadf&pid=1-s2.0-S2772368223000124-main.pdf},

year  = {2023},

date = {2023-02-02},

journal = {The Lancet Regional Health - Southeast Asia},

abstract = {BACKGROUND

The initiation of anti-tuberculosis treatment (ATT) based on results of WHO-approved microbiological diagnostics is an important marker of quality tuberculosis (TB) care. Evidence suggests that other diagnostic processes leading to treatment initiation may be preferred in high TB incidence settings. This study examines whether private providers start anti-TB therapy on the basis of chest radiography (CXR) and clinical examinations.



METHODS

This study uses the standardized patient (SP) methodology to generate accurate and unbiased estimates of private sector, primary care provider practice when a patient presents a standardized TB case scenario with an abnormal CXR. Using multivariate log-binomial and linear regressions with standard errors clustered at the provider level, we analyzed 795 SP visits conducted over three data collection waves from 2014 to 2020 in two Indian cities. Data were inverse-probability-weighted based on the study sampling strategy, resulting in city-wave-representative results.



FINDINGS

Amongst SPs who presented to a provider with an abnormal CXR, 25% (95% CI: 21–28%) visits resulted in ideal management, defined as the provider prescribing a microbiological test and not offering a concurrent prescription for a corticosteroid or antibiotic (including anti-TB medications). In contrast, 23% (95% CI: 19–26%) of 795 visits were prescribed anti-TB medications. Of 795 visits, 13% (95% CI: 10–16%) resulted in anti-TB treatment prescriptions/dispensation and an order for confirmatory microbiological testing.



INTERPRETATION

One in five SPs presenting with abnormal CXR were prescribed ATT by private providers. This study contributes novel insights to empiric treatment prevalence based on CXR abnormality. Further work is needed to understand how providers make trade-offs between existing diagnostic practices, new technologies, profits, clinical outcomes, and the market dynamics with laboratories.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Daniels2022,

title = {Tuberculosis diagnosis and management in the public versus private sector: a standardised patients study in Mumbai, India},

author = {Benjamin Daniels and Daksha Shah and Ada T Kwan and Ranendra Das and Veena Das and Varsha Puri and Pranita Tipre and Upalimitra Waghmare and Mangala Gomare and Padmaja Keskar and Jishnu Das and Madhukar Pai},

url = {https://gh.bmj.com/content/bmjgh/7/10/e009657.full.pdf?with-ds=yes},

year  = {2022},

date = {2022-10-19},

urldate = {2022-01-01},

journal = {BMJ Global Health},

volume = {7},

number = {10},

pages = {e009657},

publisher = {BMJ Specialist Journals},

abstract = {BACKGROUND

There are few rigorous studies comparing quality of tuberculosis (TB) care in public versus private sectors.



METHODS

We used standardised patients (SPs) to measure technical quality and patient experience in a sample of private and public facilities in Mumbai.



RESULTS

SPs presented a ‘classic, suspected TB’ scenario and a ‘recurrence or drug-resistance’ scenario. In the private sector, SPs completed 643 interactions. In the public sector, 164 interactions. Outcomes included indicators of correct management, medication use and client experience. Public providers used microbiological testing (typically, microscopy) more frequently, in 123 of 164 (75%; 95% CI 68% to 81%) vs 223 of 644 interactions (35%; 95% CI 31% to 38%) in the private sector. Private providers were more likely to order chest X-rays, in 556 of 639 interactions (86%; 95% CI 84% to 89%). According to national TB guidelines, we found higher proportions of correct management in the public sector (75% vs 35%; (adjusted) difference 35 percentage points (pp); 95% CI 25 to 46). If X-rays were considered acceptable for the first case but drug-susceptibility testing was required for the second case, the private sector correctly managed a slightly higher proportion of interactions (67% vs 51%; adjusted difference 16 pp; 95% CI 7 to 25). Broad-spectrum antibiotics were used in 76% (95% CI 66% to 84%) of the interactions in public hospitals, and 61% (95% CI 58% to 65%) in private facilities. Costs in the private clinics averaged rupees INR 512 (95% CI 485 to 539); public facilities charged INR 10. Private providers spent more time with patients (4.4 min vs 2.4 min; adjusted difference 2.0 min; 95% CI 1.2 to 2.9) and asked a greater share of relevant questions (29% vs 43%; adjusted difference 13.7 pp; 95% CI 8.2 to 19.3).



CONCLUSION

While the public providers did a better job of adhering to national TB guidelines (especially microbiological testing) and offered less expensive care, private sector providers did better on client experience.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Salomon2022,

title = {Prescribing practices for presumptive TB among private general practitioners in South Africa: a cross-sectional, standardised patient study},

author = {Angela Salomon and Jody Boffa and Sizulu Moyo and Jeremiah Chikovore and Giorgia Sulis and Benjamin Daniels and Ada Kwan and Tsatsawani Mkhombo and Sarah Wu and Madhukar Pai and Amrita Daftary},

url = {https://gh.bmj.com/content/bmjgh/7/1/e007456.full.pdf},

year  = {2022},

date = {2022-01-18},

journal = {BMJ Global Health},

volume = {7},

number = {1},

pages = {e007456},

abstract = {Introduction

Medicine prescribing practices are integral to quality of care for leading infectious diseases such as tuberculosis (TB). We describe prescribing practices in South Africa’s private health sector, where an estimated third of people with TB symptoms first seek care.



Methods

Sixteen standardised patients (SPs) presented one of three cases during unannounced visits to private general practitioners (GPs) in Durban and Cape Town: TB symptoms, HIV-positive; TB symptoms, a positive molecular test for TB, HIV-negative; and TB symptoms, history of incomplete TB treatment, HIV-positive. Prescribing practices were recorded in standardised exit interviews and analysed based on their potential to contribute to negative outcomes, including increased healthcare expenditures, antibiotic overuse or misuse, and TB diagnostic delay. Factors associated with antibiotic use were assessed using Poisson regression with a robust variance estimator.



Results

Between August 2018 and July 2019, 511 SP visits were completed with 212 GPs. In 88.5% (95% CI 85.2% to 91.1%) of visits, at least one medicine (median 3) was dispensed or prescribed and most (93%) were directly dispensed. Antibiotics, which can contribute to TB diagnostic delay, were the most common medicine (76.5%, 95% CI 71.7% to 80.7% of all visits). A majority (86.1%, 95% CI 82.9% to 88.5%) belonged to the WHO Access group; fluoroquinolones made up 8.8% (95% CI 6.3% to 12.3%). Factors associated with antibiotic use included if the SP was asked to follow-up if symptoms persisted (RR 1.14, 95% CI 1.04 to 1.25) and if the SP presented as HIV-positive (RR 1.11, 95% CI 1.01 to 1.23). An injection was offered in 31.9% (95% CI 27.0% to 37.2%) of visits; 92% were unexplained. Most (61.8%, 95% CI 60.2% to 63.3%) medicines were not listed on the South African Primary Healthcare Essential Medicines List.



Conclusion

Prescribing practices among private GPs for persons presenting with TB-like symptoms in South Africa raise concern about inappropriate antimicrobial use, private healthcare costs and TB diagnostic delay.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rosapep2022,

title = {Tuberculosis care quality in urban Nigeria: A cross-sectional study of adherence to screening and treatment initiation guidelines in multi-cadre networks of private health service providers},

author = {Lauren A. Rosapep and Sophie Faye and Benjamin Johns and Bolanle Olusola-Faleye and Elaine M. Baruwa and Micah K. Sorum and Flora Nwagagbo and Abdu A. Adamu and Ada Kwan and Christopher Obanubi and Akinyemi Olumuyiwa Atobatele},

url = {https://journals.plos.org/globalpublichealth/article/file?id=10.1371/journal.pgph.0000150&type=printable},

year  = {2022},

date = {2022-01-06},

journal = {PLoS Global Public Health},

volume = {2},

number = {1},

pages = {e0000150},

abstract = {Nigeria has a high burden of tuberculosis (TB) and low case detection rates. Nigeria’s large private health sector footprint represents an untapped resource for combating the disease. To examine the quality of private sector contributions to TB, the USAID-funded Sustaining Health Outcomes through the Private Sector (SHOPS) Plus program evaluated adherence to national standards for management of presumptive and confirmed TB among the clinical facilities, laboratories, pharmacies, and drug shops it trained to deliver TB services. The study used a standardized patient (SP) survey methodology to measure case management protocol adherence among 837 private and 206 public providers in urban Lagos and Kano. It examined two different scenarios: a “textbook” case of presumptive TB and a treatment initiation case where SPs presented as referred patients with confirmed TB diagnoses. Private sector results were benchmarked against public sector results. A bottleneck analysis examined protocol adherence departures at key points along the case management sequence that providers were trained to follow. Except for laboratories, few providers met the criteria for fully correct management of presumptive TB, though more than 70% of providers correctly engaged in TB screening. In the treatment initiation case 18% of clinical providers demonstrated fully correct case management. Private and public providers’ adherence was not significantly different. Bottleneck analysis revealed that the most common deviations from correct management were failure to initiate sputum collection for presumptive patients and failure to conduct sufficiently thorough treatment initiation counseling for confirmed patients. This study found the quality of private providers’ TB case management to be comparable to public providers in Nigeria, as well as to providers in other high burden countries. Findings support continued efforts to include private providers in Nigeria’s national TB program. Though most providers fell short of desired quality, the bottleneck analysis points to specific issues that TB stakeholders can feasibly address with system- and provider-level interventions.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Das2021,

title = {Simulated patients and their reality: An inquiry into theory and method},

author = {Veena Das and Benjamin Daniels and Ada Kwan and Vaibhav Saria and Ranendra Das and Madhukar Pai and Jishnu Das},

url = {https://www.sciencedirect.com/science/article/pii/S0277953621009035/pdfft?md5=6d52fdbf820c7a643380cbc7926bb033&pid=1-s2.0-S0277953621009035-main.pdf},

year  = {2021},

date = {2021-11-25},

urldate = {2021-11-25},

journal = {Social Science & Medicine},

pages = {114571},

publisher = {Elsevier},

abstract = {Simulated standardized patients (SSP) have emerged as close to a ‘gold standard’ for measuring the quality of clinical care. This method resolves problems of patient mix across healthcare providers and allows care to be benchmarked against preexisting standards. Nevertheless, SSPs are not real patients. How, then, should data from SSPs be considered relative to clinical observations with ‘real’ patients in a given health system?



Here, we reject the proposition that SSPs are direct substitutes for real patients and that the validity of SSP studies therefore relies on their ability to imitate real patients. Instead, we argue that the success of the SSP methodology lies in its counterfactual manipulations of the possibilities available to real careseekers – especially those paths not taken up by them – through which real responses can be elicited from real providers.



Using results from a unique pilot study where SSPs returned to providers for follow-ups when asked, we demonstrate that the SSP method works well to elicit responses from the provider through conditional manipulations of SSP behavior. At the same time, observational methods are better suited to understand what choices real people make, and how these can affect the direction of diagnosis and treatment. A combination of SSP and observational methods can thus help parse out how quality of care emerges for the “patient” as a shared history between care-seeking individuals and care providers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Huddart2021,

title = {Case fatality and recurrent tuberculosis among patients managed in the private sector: A cohort study in Patna, India},

author = {Sophie Huddart and Mugdha Singh and Nita Jha and Andrea Benedetti and Madhukar Pai},

url = {https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0249225&type=printable},

year  = {2021},

date = {2021-03-26},

urldate = {2021-03-26},

journal = {PLoS One},

volume = {16},

number = {3},

pages = {1-16},

publisher = {Public Library of Science},

abstract = {BACKGROUND

A key component of the WHO End TB Strategy is quality of care, for which case fatality is a critical marker. Half of India’s nearly 3 million TB patients are treated in the highly unregulated private sector, yet little is known about the outcomes of these patients. Using a retrospective cohort design, we estimated the case fatality ratio (CFR) and rate of recurrent TB among patients managed in the private healthcare sector in Patna, India.



METHODS

World Health Partners’ Private Provider Interface Agencies (PPIA) pilot project in Patna has treated 89,906 private sector TB patients since 2013. A random sample of 4,000 patients treated from 2014 to 2016 were surveyed in 2018 for case fatality and recurrent TB. CFR is defined as the proportion of patients who die during the period of interest. Treatment CFRs, post-treatment CFRs and rates of recurrent TB were estimated. Predictors for fatality and recurrence were identified using Cox proportional hazards modelling. Survey non-response was adjusted for using inverse probability selection weighting.



RESULTS

The survey response rate was 56.0%. The weighted average follow-up times were 8.7 months in the treatment phase and 26.4 months in the post-treatment phase. Unobserved patients were more likely to have less than one month of treatment adherence (32.0% vs. 13.5%) and were more likely to live in rural Patna (21.9% vs. 15.0%). The adjusted treatment phase CFR was 7.27% (5.97%, 8.49%) and at 24 months post-treatment was 3.32% (2.36%, 4.42%). The adjusted 24 month post-treatment phase recurrent TB rate was 3.56% (2.54%, 4.79%).



CONCLUSIONS

Our cohort study provides critical estimates of TB patient outcomes in the Indian private sector, and accounts for selection bias. Patients in the private sector in Patna experienced a moderate treatment CFR but rates of recurrent TB and post-treatment fatality were low.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{McDowell2021,

title = {Dr. Zahir’s dilemma: money and morals in India’s private medical networks},

author = {Andrew McDowell},

url = {https://www.qutubproject.org/wp-content/uploads/2017/09/2021-01-McDowellA-BioS.pdf},

year  = {2021},

date = {2021-01-13},

journal = {BioSocieties},

pages = {1--24},

publisher = {Springer},

abstract = {Public health experts often describe care in India’s private sector as ‘chaotic,’ ‘substandard,’ ‘profit-driven,’ and ‘arbitrary.’ Discourse tends to focus on the ‘predatory behavior' of doctors who demand consultation fees and kickbacks for everything from medicine, to laboratory tests, to specialist referrals, and even hospital stays. These practices are ethnographically observable. However, this discourse does not take into account the multiple uncertainties, ethical complexity, and personal relationships involved in providing care in exchange for money in a setting of scarce personal and public resources. Situated at the very end of a value chain designed to make money from health, or the lack thereof, private physicians find themselves embroiled in moral peril. In this article, I engage what it means to make a livelihood in a context such as this by considering the economic, moral, and epistemic practices that physicians and their patients use to create and evaluate the value of pharmaceuticals in Mumbai’s slums. Based on over a year of clinic ethnography and interviews with family physicians, specialists, pharmacists, and pharmaceutical wholesalers, I trace how physicians manage the effects of a pharmaceutical value chain that produces profit by fulfilling patient’s health needs and desires.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Sulis2020b,

title = {Antibiotic overuse in the primary health care setting: a secondary data analysis of standardised patient studies from India, China and Kenya},

author = {Giorgia Sulis and Benjamin Daniels and Ada Kwan and Sumanth Gandra and Amrita Daftary and Jishnu Das and Madhukar Pai},

url = {https://gh.bmj.com/content/bmjgh/5/9/e003393.full.pdf},

year  = {2020},

date = {2020-09-15},

journal = {BMJ Global Health},

volume = {2020},

number = {5},

pages = {e003393},

abstract = {Introduction

Determining whether antibiotic prescriptions are inappropriate requires knowledge of patients’ underlying conditions. In low-income and middle-income countries (LMICs), where misdiagnoses are frequent, this is challenging. Additionally, such details are often unavailable for prescription audits. Recent studies using standardised patients (SPs) offer a unique opportunity to generate unbiased prevalence estimates of antibiotic overuse, as the research design involves patients with predefined conditions.



Methods

Secondary analyses of data from nine SP studies were performed to estimate the proportion of SP–provider interactions resulting in inappropriate antibiotic prescribing across primary care settings in three LMICs (China, India and Kenya). In all studies, SPs portrayed conditions for which antibiotics are unnecessary (watery diarrhoea, presumptive tuberculosis (TB), angina and asthma). We conducted descriptive analyses reporting overall prevalence of antibiotic overprescribing by healthcare sector, location, provider qualification and case. The WHO Access–Watch–Reserve framework was used to categorise antibiotics based on their potential for selecting resistance. As richer data were available from India, we examined factors associated with antibiotic overuse in that country through hierarchical Poisson models.



Results

Across health facilities, antibiotics were given inappropriately in 2392/4798 (49.9%, 95% CI 40.8% to 54.5%) interactions in India, 83/166 (50.0%, 95% CI 42.2% to 57.8%) in Kenya and 259/899 (28.8%, 95% CI 17.8% to 50.8%) in China. Prevalence ratios of antibiotic overuse in India were significantly lower in urban versus rural areas (adjusted prevalence ratio (aPR) 0.70, 95% CI 0.52 to 0.96) and higher for qualified versus non-qualified providers (aPR 1.55, 95% CI 1.42 to 1.70), and for presumptive TB cases versus other conditions (aPR 1.19, 95% CI 1.07 to 1.33). Access antibiotics were predominantly used in Kenya (85%), but Watch antibiotics (mainly quinolones and cephalosporins) were highly prescribed in India (47.6%) and China (32.9%).



Conclusion

Good-quality SP data indicate alarmingly high levels of antibiotic overprescription for key conditions across primary care settings in India, China and Kenya, with broad-spectrum agents being excessively used in India and China.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Sulis2020,

title = {Antibiotic prescription practices in primary care in low- and middle-income countries: A systematic review and meta-analysis},

author = {Giorgia Sulis and Pierrick Adam and Vaidehi Nafade and Genevieve Gore and Benjamin Daniels and Amrita Daftary and Jishnu Das and Sumanth Gandra and Madhukar Pai},

url = {https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1003139&type=printable},

year  = {2020},

date = {2020-06-16},

journal = {PLoS Medicine},

volume = {17},

number = {6},

pages = {1-20},

abstract = {Background

The widespread use of antibiotics plays a major role in the development and spread of antimicrobial resistance. However, important knowledge gaps still exist regarding the extent of their use in low- and middle-income countries (LMICs), particularly at the primary care level. We performed a systematic review and meta-analysis of studies conducted in primary care in LMICs to estimate the prevalence of antibiotic prescriptions as well as the proportion of such prescriptions that are inappropriate.



Methods and findings

We searched PubMed, Embase, Global Health, and CENTRAL for articles published between 1 January 2010 and 4 April 2019 without language restrictions. We subsequently updated our search on PubMed only to capture publications up to 11 March 2020. Studies conducted in LMICs (defined as per the World Bank criteria) reporting data on medicine use in primary care were included. Three reviewers independently screened citations by title and abstract, whereas the full-text evaluation of all selected records was performed by 2 reviewers, who also conducted data extraction and quality assessment. A modified version of a tool developed by Hoy and colleagues was utilized to evaluate the risk of bias of each included study. Meta-analyses using random-effects models were performed to identify the proportion of patients receiving antibiotics. The WHO Access, Watch, and Reserve (AWaRe) framework was used to classify prescribed antibiotics. We identified 48 studies from 27 LMICs, mostly conducted in the public sector and in urban areas, and predominantly based on medical records abstraction and/or drug prescription audits. The pooled prevalence proportion of antibiotic prescribing was 52% (95% CI: 51%–53%), with a prediction interval of 44%–60%. Individual studies’ estimates were consistent across settings. Only 9 studies assessed rationality, and the proportion of inappropriate prescription among patients with various conditions ranged from 8% to 100%. Among 16 studies in 15 countries that reported details on prescribed antibiotics, Access-group antibiotics accounted for more than 60% of the total in 12 countries. The interpretation of pooled estimates is limited by the considerable between-study heterogeneity. Also, most of the available studies suffer from methodological issues and report insufficient details to assess appropriateness of prescription.



Conclusions

Antibiotics are highly prescribed in primary care across LMICs. Although a subset of studies reported a high proportion of inappropriate use, the true extent could not be assessed due to methodological limitations. Yet, our findings highlight the need for urgent action to improve prescription practices, starting from the integration of WHO treatment recommendations and the AWaRe classification into national guidelines.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Saria2020b,

title = {New Machine, Old Cough: Technology and Tuberculosis in Patna},

author = {V Saria},

url = {https://www.qutubproject.org/wp-content/uploads/2017/09/2020-04-SariaV-FS.pdf},

year  = {2020},

date = {2020-04-03},

journal = {Frontiers in Sociology},

volume = {5},

number = {18},

pages = {1-11},

abstract = {In 2013, a new technology, GeneXpert, was introduced in India, which, in addition to testing for TB, could also diagnose whether the detected strain was drug resistant. By detecting the bacterium more effectively than other available tests and simultaneously testing for resistance, GeneXpert promised to reduce the delay in diagnosis and hence ineffective treatments. The new test was introduced to multiple cities via a coalition that included global health funding bodies, the government of India, the World Health Organization, and non-governmental organizations. Despite the concerted effort of the coalition, among formal providers (those trained in biomedicine) in the private sector, the new technology was not adopted as quickly as had been hoped. Examining formal providers’ initial responses to the technology’s introduction in the city of Patna reveals how the adoption of new technology can be influenced by the particularities of the local medical market such as the availability of diagnostic tests, presence of informal providers, and reputation of formal providers. While protocols and operations might seem standardized across implementation plans, the work that is required to ensure success must take into account the particular role that the market plays from site to site.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{kwan2019use,

title = {Use of standardised patients for healthcare quality research in low-and middle-income countries},

author = {Ada Kwan and Benjamin Daniels and Sofi Bergkvist and Veena Das and Madhukar Pai and Jishnu Das},

url = {https://gh.bmj.com/content/bmjgh/4/5/e001669.full.pdf, Paper

https://gh.bmj.com/content/bmjgh/4/5/e001908.full.pdf, Accompanying editorial},

year  = {2019},

date = {2019-09-12},

journal = {BMJ Global Health},

volume = {4},

number = {5},

pages = {e001669},

publisher = {BMJ Specialist Journals},

abstract = {The use of standardised patients (SPs)—people recruited from the local community to present the same case to multiple providers in a blinded fashion—is increasingly used to measure the quality of care in low-income and middle-income countries. Encouraged by the growing interest in the SP method, and based on our experience of conducting SP studies, we present a conceptual framework for research designs and surveys that use this methodology. We accompany the conceptual framework with specific examples, drawn from our experience with SP studies in low-income and middle-income contexts, including China, India, Kenya and South Africa, to highlight the versatility of the method and illustrate the ongoing challenges. A toolkit and manual for implementing SP studies is included as a companion piece in the online supplement.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Agins2019b,

title = {Improving the cascade of global tuberculosis care: moving from the “what” to the “how” of quality improvement},

author = {Bruce D Agins and Daniel J Ikeda and Michael JA Reid and Eric Goosby and Madhukar Pai and Adithya Cattamanchi},

url = {https://www.paitbgroup.org/wp-content/uploads/Papers/2019/2019-08-Agins-LID.pdf},

year  = {2019},

date = {2019-08-22},

journal = {The Lancet Infectious Diseases},

publisher = {Elsevier},

abstract = {Tuberculosis is preventable, treatable, and curable, yet it has the highest mortality rate of infectious diseases worldwide. Over the past decade, services to prevent, screen, diagnose, and treat tuberculosis have been developed and scaled up globally, but progress to end the disease as a public health threat has been slow, particularly in low-income and middle-income countries. In these settings, low-quality tuberculosis prevention, diagnostic, and treatment services frustrate efforts to translate use of existing tools, approaches, and treatment regimens into improved individual and public health outcomes. Increasingly sophisticated methods have been used to identify gaps in quality of tuberculosis care, but inadequate work has been done to apply these findings to activities that generate population-level improvements. In this Personal View, we contend that shifting the focus from the “what” to the “how” of quality improvement will require National Tuberculosis Programmes to change the way they organise, use data, implement, and respond to the needs and preferences of people with tuberculosis and at-risk communities.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{King2019,

title = {How to do (or not to do) … using the standardized patient method to measure clinical quality of care in LMIC health facilities},

author = {Jessica J C King and Jishnu Das and Ada Kwan and Benjamin Daniels and Timothy Powell-Jackson and Christina Makungu and Catherine Goodman},

url = {https://academic.oup.com/heapol/advance-article/doi/10.1093/heapol/czz078/5551391},

doi = {10.1093/heapol/czz078},

issn = {0268-1080},

year  = {2019},

date = {2019-08-19},

journal = {Health Policy and Planning},

volume = {2019},

pages = {1-10},

abstract = {Standardized patients (SPs), i.e. mystery shoppers for healthcare providers, are increasingly used as a tool to measure quality of clinical care, particularly in low- and middle-income countries where medical record abstraction is unlikely to be feasible. The SP method allows care to be observed without the provider’s knowledge, removing concerns about the Hawthorne effect, and means that providers can be directly compared against each other. However, their undercover nature means that there are methodological and ethical challenges beyond those found in normal fieldwork. We draw on a systematic review and our own experience of implementing such studies to discuss six key steps in designing and executing SP studies in healthcare facilities, which are more complex than those in retail settings. Researchers must carefully choose the symptoms or conditions the SPs will present in order to minimize potential harm to fieldworkers, reduce the risk of detection and ensure that there is a meaningful measure of clinical care. They must carefully define the types of outcomes to be documented, develop the study scripts and questionnaires, and adopt an appropriate sampling strategy. Particular attention is required to ethical considerations and to assessing detection by providers. Such studies require thorough planning, piloting and training, and a dedicated and engaged field team. With sufficient effort, SP studies can provide uniquely rich data, giving insights into how care is provided which is of great value to both researchers and policymakers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Daniels2019c,

title = {Lessons on the quality of tuberculosis diagnosis from standardized patients in China, India, Kenya, and South Africa},

author = {Benjamin Daniels and Ada Kwan and Madhukar Pai and Jishnu Das},

url = {https://www.sciencedirect.com/science/article/pii/S2405579419300270/pdfft?md5=99968392015916fe0825bd04ab91ea91&pid=1-s2.0-S2405579419300270-main.pdf},

year  = {2019},

date = {2019-06-07},

journal = {Journal of Clinical Tuberculosis and Other Mycobacterial Diseases},

volume = {16},

pages = {100109},

publisher = {Elsevier},

abstract = {Standardized patients (SPs) are people who are recruited locally, trained to make identical scripted clinical presentations, deployed incognito to multiple different health care providers, and debriefed using a structured reporting instrument. The use of SPs has increased dramatically as a method for assessing quality of TB care since it was first validated and used for tuberculosis in 2015. This paper summarizes common findings using 3,086 SP-provider interactions involving tuberculosis across various sampling strata in published studies from India, China, South Africa and Kenya. It then discusses the lessons learned from implementing standardized patients in these diverse settings. First, quality is low: relatively few SPs presenting to a health care provider for the first time were given an appropriate diagnostic test, and most were given unnecessary or inappropriate medication. Second, care takes a wide variety of forms – SPs did not generally receive “wait and see” or “symptomatic” care from providers, but they received a medley of care patterns that included broad-spectrum antibiotics as well as contraindicated quinolone antibiotics and steroids. Third, there is a wide range of estimated quality in each observed sampling stratum: more-qualified providers and higher-level facilities performed better than others in all settings, but in every stratum there were both high- and low-quality providers. Evidence from SP studies paired with medical vignettes has shown that providers of all knowledge levels significantly underperform their demonstrated ability with real patients. Finally, providers showed little response to differences in patient identity, but showed strong responses to differences in case presentation that give some clues as to the reasons for these behaviors.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Daniels2019,

title = {Use of standardised patients to assess gender differences in quality of tuberculosis care in urban India: a two-city, cross-sectional study},

author = {Benjamin Daniels and Ada Kwan and Srinath Satyanarayana and Ramnath Subbaraman and Ranendra K Das and Veena Das and Jishnu Das and Madhukar Pai},

url = {https://www.thelancet.com/action/showPdf?pii=S2214-109X%2819%2930031-2},

doi = {10.1016/S2214-109X(19)30031-2},

year  = {2019},

date = {2019-03-27},

journal = {The Lancet Global Health},

pages = {1-11},

abstract = {Background

In India, men are more likely than women to have active tuberculosis but are less likely to be diagnosed and notified to national tuberculosis programmes. We used data from standardised patient visits to assess whether these gender differences occur because of provider practice.



Methods

We sent standardised patients (people recruited from local populations and trained to portray a scripted medical condition to health-care providers) to present four tuberculosis case scenarios to private health-care providers in the cities of Mumbai and Patna. Sampling and weighting allowed for city representative interpretation. Because standardised patients were assigned to providers by a field team blinded to this study, we did balance and placebo regression tests to confirm standardised patients were assigned by gender as good as randomly. Then, by use of linear and logistic regression, we assessed correct case management, our primary outcome, and other dimensions of care by standardised patient gender.



Findings

Between Nov 21, 2014, and Aug 21, 2015, 2602 clinical interactions at 1203 private facilities were completed by 24 standardised patients (16 men, eight women). We found standardised patients were assigned to providers as good as randomly. We found no differences in correct management by patient gender (odds ratio 1·05; 95% CI 0·76–1·45; p=0·77) and no differences across gender within any case scenario, setting, provider gender, or provider qualification.



Interpretation

Systematic differences in quality of care are unlikely to be a cause of the observed under-representation of men in tuberculosis notifications in the private sector in urban India.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Subbaraman2019,

title = {Constructing care cascades for active tuberculosis: A strategy for program monitoring and identifying gaps in quality of care},

author = {Ramnath Subbaraman and Ruvandhi R Nathavitharana and Kenneth H Mayer and Srinath Satyanarayana and Vineet K Chadha and Nimalan Arinaminpathy and Madhukar Pai},

url = {https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1002754&type=printable},

doi = {10.1371/journal.pmed.1002754},

year  = {2019},

date = {2019-02-27},

journal = {PLoS Medicine},

volume = {16},

number = {2},

pages = {1-18},

publisher = {Public Library of Science},

abstract = {The cascade of care is a model for evaluating patient retention across sequential stages of care required to achieve a successful treatment outcome. This approach was first used to evaluate HIV care and has since been applied to other diseases. The tuberculosis (TB) community has only recently started using care cascade analyses to quantify gaps in quality of care. In this article, we describe methods for estimating gaps (patient losses) and steps (patients retained) in the care cascade for active TB disease. We highlight approaches for overcoming challenges in constructing the TB care cascade, which include difficulties in estimating the population-level burden of disease and the diagnostic gap due to the limited sensitivity of TB diagnostic tests. We also describe potential uses of this model for evaluating the impact of interventions to improve case finding, diagnosis, linkage to care, retention in care, and post-treatment monitoring of TB patients.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Pai2018b,

title = {Quality: the missing ingredient in TB care and control},

author = {Madhukar Pai and Zelalem Temesgen},

url = {https://www.sciencedirect.com/science/article/pii/S2405579418300846/pdfft?md5=522e3d85373483192cb3dae1e72f29bb&pid=1-s2.0-S2405579418300846-main.pdf},

year  = {2019},

date = {2019-01-04},

journal = {Journal of Clinical Tuberculosis and Other Mycobacterial Diseases},

volume = {14},

pages = {12-13},

publisher = {Elsevier},

abstract = {Good health is a function of the utilization of healthcare services and the quality of healthcare. In the field of global health, there is growing awareness of the need to go beyond coverage of services and improve the quality of care.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kwan2018,

title = {Variations in the quality of tuberculosis care in urban India: A cross-sectional, standardized patient study in two cities},

author = {Ada Kwan and Benjamin Daniels and Vaibhav Saria and Srinath Satyanarayana and Ramnath Subbaraman and Andrew McDowell and Sofi Bergkvist and Ranendra K. Das and Veena Das and Jishnu Das and Madhukar Pai},

url = {https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1002653&type=printable},

year  = {2018},

date = {2018-09-25},

journal = {PLoS Medicine},

volume = {15},

number = {9},

pages = {e1002653},

abstract = {India has the highest burden of tuberculosis (TB). Although most patients with TB in India seek care from the private sector, there is limited evidence on quality of TB care or its correlates. Following our validation study on the standardized patient (SP) method for TB, we utilized SPs to examine quality of adult TB care among health providers with different qualifications in 2 Indian cities.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{miller2017quality,

title = {Quality of tuberculosis care by Indian pharmacies: mystery clients offer new insights},

author = {Rosalind Miller and Jishnu Das and Madhukar Pai},

url = {https://www.sciencedirect.com/science/article/pii/S2405579417300669},

year  = {2018},

date = {2018-01-01},

journal = {Journal of Clinical Tuberculosis and Other Mycobacterial Diseases},

volume = {10},

pages = {6-8},

publisher = {Elsevier},

abstract = {For many patients in India, pharmacies are their first point of contact, where most drugs, including antibiotics, can be purchased over-the-counter (OTC). Recent standardised (simulated) patient studies, covering four Indian cities, provide new insights on how Indian pharmacies manage patients with suspected or known tuberculosis. Correct management of the simulated patients ranged from 13% to 62%, increasing with the certainty of the TB diagnosis. Antibiotics were frequently dispensed OTC to patients, with 16% to 37% receiving such drugs across the cases. On a positive note, these studies showed that no pharmacy dispensed first-line anti-TB drugs. Engagement of pharmacies is important to not only improve TB detection and care, but also limit the abuse of antibiotics.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{cazabon2017quality,

title = {Quality of tuberculosis care in high burden countries: the urgent need to address gaps in the care cascade},

author = {Danielle Cazabon and Hannah Alsdurf and Srinath Satyanarayana and Ruvandhi Nathavitharana and Ramnath Subbaraman and Amrita Daftary and Madhukar Pai},

url = {http://www.paitbgroup.org/wp-content/uploads/Papers/2017/2017-03-CazabonD-IJID.pdf, Full article},

year  = {2017},

date = {2017-03-01},

journal = {International Journal of Infectious Diseases},

volume = {56},

pages = {111--116},

publisher = {Elsevier},

abstract = {Summary

Despite the high coverage of directly observed treatment short-course (DOTS), tuberculosis (TB) continues to affect 10.4 million people each year, and kills 1.8 million. High TB mortality, the large number of missing TB cases, the emergence of severe forms of drug resistance, and the slow decline in TB incidence indicate that merely expanding the coverage of TB services is insufficient to end the epidemic. In the era of the End TB Strategy, we need to think beyond coverage and start focusing on the quality of TB care that is routinely offered to patients in high burden countries, in both public and private sectors. In this review, current evidence on the quality of TB care in high burden countries, major gaps in the quality of care, and some novel efforts to measure and improve the quality of care are described. Based on systematic reviews on the quality of TB care or surrogates of quality (e.g., TB diagnostic delays), analyses of TB care cascades, and newer studies that directly measure quality of care, it is shown that the quality of care in both the public and private sector falls short of international standards and urgently needs improvement. National TB programs will therefore need to systematically measure and improve quality of TB care and invest in quality improvement programs.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Satyanarayana2016,

title = {Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional study},

author = {Srinath Satyanarayana and Ada Kwan and Benjamin Daniels and Ramnath Subbaraman and Andrew McDowell and Sofi Bergkvist and Ranendra K Das and Veena Das and Jishnu Das and Madhukar Pai},

url = {http://www.paitbgroup.org/wp-content/uploads/Papers/2016/2016-11-SatyanarayanaS-LID.pdf, Full article

https://qutubproject.github.io/lancetid2016, Source data},

year  = {2016},

date = {2016-08-24},

journal = {The Lancet Infectious Diseases},

volume = {16},

number = {11},

pages = {1261--1268},

publisher = {Elsevier},

abstract = {Background

India's total antibiotic use is the highest of any country. Patients often receive prescription-only drugs directly from pharmacies. Here we aimed to assess the medical advice and drug dispensing practices of pharmacies for standardised patients with presumed and confirmed tuberculosis in India.



Methods

In this cross-sectional study in the three Indian cities Delhi, Mumbai, and Patna, we developed two standardised patient cases: first, a patient presenting with 2–3 weeks of pulmonary tuberculosis symptoms (Case 1); and second, a patient with microbiologically confirmed pulmonary tuberculosis (Case 2). Standardised patients were scheduled to present each case once to sampled pharmacies. We defined ideal management for both cases a priori as referral to a health-care provider without dispensing antibiotics or steroids or both.



Findings

Between April 1, 2014, and Nov 29, 2015, we sampled 622 pharmacies in Delhi, Mumbai, and Patna. Standardised patients completed 1200 (96%) of 1244 interactions. We recorded ideal management (defined as referrals without the use of antibiotics or steroids) in 80 (13%) of 599 Case 1 interactions (95% CI 11–16) and 372 (62%) of 601 Case 2 interactions (95% CI 58–66). Antibiotic use was significantly lower in Case 2 interactions (98 [16%] of 601, 95% CI 13–19) than in Case 1 (221 [37%] of 599, 95% CI 33–41). First-line anti-tuberculosis drugs were not dispensed in any city. The differences in antibiotic or steroid use and number of medicines dispensed between Case 1 and Case 2 were almost entirely attributable to the difference in referral behaviour.



Interpretation

Only some urban Indian pharmacies correctly managed patients with presumed tuberculosis, but most correctly managed a case of confirmed tuberculosis. No pharmacy dispensed anti-tuberculosis drugs for either case. Absence of a confirmed diagnosis is a key driver of antibiotic misuse and could inform antimicrobial stewardship interventions.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{McDowell2016,

title = {Treatment as diagnosis and diagnosis as treatment: empirical management of presumptive tuberculosis in India},

author = {A McDowell and M Pai},

url = {http://www.paitbgroup.org/wp-content/uploads/Papers/2016/2016-04-McDowellA-IJTLD.pdf, Full article},

year  = {2016},

date = {2016-04-01},

journal = {The International Journal of Tuberculosis and Lung Disease},

volume = {20},

number = {4},

pages = {536--543},

publisher = {International Union Against Tuberculosis and Lung Disease},

abstract = {BACKGROUND: Mismanagement of TB is a concern in the Indian private sector, and empirical management might be a key contributor.



OBJECTIVE: To understand factors associated with empirical diagnosis and treatment of presumed TB in India's private sector and examine their effects on TB care.



DESIGN: In this ethnographic study, 110 private practitioners of varying qualification who interacted with TB patients (90 in Mumbai and 20 in Patna) were interviewed, and a subset was observed while providing clinical care. Interviews and observations were analysed for indicators of empirical diagnosis and treatment.



RESULTS: All non-specialist practitioners began antibiotic treatment, especially quinolones, for persistent cough before prescribing a test. Several factors contribute to empirical management. These include a common practice use of medications as diagnostic tools, a desire to provide rapid symptom relief to patients, a desire to manage illness costs effectively, uncertainty about the presentation of TB, the effects of broad spectrum antibiotics on TB symptomology, and uncertainty about the accuracy of available TB tests.



CONCLUSION: Empiricism in general and in TB care is widespread in the urban private sector in India. Ethnography might offer useful insights for addressing this in public-private mix models. },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{McDowell2016,

title = {Alternative medicine: an ethnographic study of how practitioners of Indian medical systems manage TB in Mumbai},

author = {Andrew McDowell and Madhukar Pai},

url = {http://www.paitbgroup.org/wp-content/uploads/Papers/2016/2016-03-McDowellA-TRSTMH.pdf, Full article},

year  = {2016},

date = {2016-01-01},

journal = {Transactions of The Royal Society of Tropical Medicine and Hygiene},

volume = {110},

number = {3},

pages = {192--198},

publisher = {Oxford University Press},

abstract = {Background

Mumbai is a hot spot for drug-resistant TB, and private practitioners trained in AYUSH systems (Ayurveda, yoga, Unani, Siddha and homeopathy) are major healthcare providers. It is important to understand how AYUSH practitioners manage patients with TB or presumptive TB.



Methods

We conducted semi-structured interviews of 175 Mumbai slum-based practitioners holding degrees in Ayurveda, homeopathy and Unani. Most providers gave multiple interviews. We observed 10 providers in clinical interactions, documenting: clinical examinations, symptoms, history taking, prescriptions and diagnostic tests.



Results

No practitioners exclusively used his or her system of training. The practice of biomedicine is frequent, with practitioners often using biomedical disease categories and diagnostics. The use of homeopathy was rare (only 4% of consultations with homeopaths resulted in homeopathic remedies) and Ayurveda rarer (3% of consultations). For TB, all mentioned chest x-ray while 31 (17.7%) mentioned sputum smear as a TB test. One hundred and sixty-four practitioners (93.7%) reported referring TB patients to a public hospital or chest physician. Eleven practitioners (6.3%) reported treating patients with TB. Nine (5.1%) reported treating patients with drug-susceptible TB with at least one second-line drug.



Conclusions

Important sources of health care in Mumbai's slums, AYUSH physicians frequently use biomedical therapies and most refer patients with TB to chest physicians or the public sector. They are integral to TB care and control.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Das2015,

title = {Use of standardised patients to assess quality of tuberculosis care: a pilot, cross-sectional study},

author = {Jishnu Das and Ada Kwan and Benjamin Daniels and Srinath Satyanarayana and Ramnath Subbaraman and Sofi Bergkvist and Ranendra K Das and Veena Das and Madhukar Pai},

url = {http://www.paitbgroup.org/wp-content/uploads/Papers/2015/2015-08-DasJ-LID.pdf, Full article

https://qutubproject.github.io/lancetid2015, Source data},

year  = {2015},

date = {2015-08-10},

journal = {The Lancet Infectious Diseases},

volume = {15},

number = {11},

pages = {1305--1313},

publisher = {Elsevier},

abstract = {Background

Existing studies of the quality of tuberculosis care have relied on recall-based patient surveys, questionnaire surveys of knowledge, and prescription or medical record analysis, and the results mostly show the health-care provider's knowledge rather than actual practice. No study has used standardised patients to assess clinical practice. Therefore we aimed to assess quality of care for tuberculosis using such patients.



Methods

We did a pilot, cross-sectional validation study of a convenience sample of consenting private health-care providers in low-income and middle-income areas of Delhi, India. We recruited standardised patients in apparently good health from the local community to present four cases (two of presumed tuberculosis and one each of confirmed tuberculosis and suspected multidrug-resistant tuberculosis) to a randomly allocated health-care provider. The key objective was to validate the standardised-patient method using three criteria: negligible risk and ability to avoid adverse events for providers and standardised patients, low detection rates of standardised patients by providers, and data accuracy across standardised patients and audio verification of standardised-patient recall. We also used medical vignettes to assess providers' knowledge of presumed tuberculosis. Correct case management was benchmarked using Standards for Tuberculosis Care in India (STCI).



Findings

Between Feb 2, and March 28, 2014, we recruited and trained 17 standardised patients who had 250 interactions with 100 health-care providers, 29 of whom were qualified in allopathic medicine (ie, they had a Bachelor of Medicine & Surgery [MBBS] degree), 40 of whom practised alternative medicine, and 31 of whom were informal health-care providers with few or no qualifications. The interactions took place between April 1, and April 23, 2014. The proportion of detected standardised patients was low (11 [5%] detected out of 232 interactions among providers who completed the follow-up survey), and standardised patients' recall correlated highly with audio recordings (r=0·63 [95% CI 0·53–0·79]), with no safety concerns reported. The mean consultation length was 6 min (95% CI 5·5–6·6) with a mean of 6·18 (5·72–6·64) questions or examinations completed, representing 35% (33–38) of essential checklist items. Across all cases, only 52 (21% [16–26]) of 250 were correctly managed. Correct management was higher among MBBS-qualified doctors than other types of health-care provider (adjusted odds ratio 2·41 [95% CI 1·17–4·93]; p=0·0166). Of the 69 providers who completed the vignette, knowledge in the vignettes was more consistent with STCI than their actual clinical practice—eg, 50 (73%) ordered a chest radiograph or sputum test during the vignette compared with seven (10%) during the standardised-patient interaction; OR 0·04 (95% CI 0·02–0·11); p<0·0001.



Interpretation

Standardised patients can be successfully implemented to assess tuberculosis care. Our data suggest a big gap between private provider knowledge and practice. Additional work is needed to substantiate our pilot data, understand the know-do gap in provider behaviour, and to identify the best approach to measure and improve the quality of tuberculosis care in India.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}