Do private providers initiate anti-tuberculosis therapy on the basis of chest radiographs? A standardised patient study in urban India.

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. Funding: This study was funded by the Bill & Melinda Gates Foundation (grant OPP1091843), and the Knowledge for Change Program at The World Bank.

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

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.

Tuberculosis case fatality in India: a systematic review and meta-analysis.

Introduction: The WHO End TB Strategy calls for a global reduction in the case fatality ratio (CFR) below 5%. India accounts for a third of global tuberculosis (TB) deaths. This systematic review estimated CFRs among Indian patients with TB both during and after treatment. Methods: We systematically searched Medline, Embase and Global Health for eligible studies published between 1 January 2006 and 8 January 2019, including both cohort studies and intervention study control arms that followed Indian patients with TB for fatality either during treatment or post-treatment. From relevant studies we extracted CFRs in addition to study demographics. Study quality was assessed using modified Scottish Intercollegiate Guidelines Network cohort criteria. Sufficiently homogenous studies were pooled using a random effect generalised linear mixed model. A meta-regression was performed to associate study characteristics with resulting CFRs. Results: 218 relevant studies were identified, of which 211 provided treatment phase CFRs. Most patients (92.4%) were treated in the public sector. Quality concerns were identified in 74% of papers. We estimated a pooled treatment phase CFR of 5.16% (95% CI 4.20% to 6.34%) which fell to 3.78% (2.77% to 5.16%) when restricted to 52 high-quality studies. Treatment phase CFRs were higher for paediatric (n=27, 6.50% (2.65% to 10.36%)), drug-resistant (n=43, 14.06% (10.15% to 19.49%)) and HIV-infected (n=35, 10.91% (7.68% to 15.50%)) patients. Nineteen post-treatment CFR studies were too heterogeneous to pool except when restricting to three high-quality studies (2.69% (-0.79% to 6.18%)). Poor study quality (OR=2.27 (2.01 to 2.57)) and tertiary centres patients (OR=1.15 (1.03 to 1.28)) were significantly associated with increased treatment phase case fatality. Conclusions: Case fatality is a critical measure of the quality of TB care. While India's treatment CFRs are in line with WHO targets, several key patient groups remain understudied and most studies suffer from methodological issues. Increased high-quality reporting on patient outcomes will help improve the evidence base on this topic.

Differential yield of universal versus selective drug susceptibility testing of patients with tuberculosis in high-burden countries: a systematic review and meta-analysis.

INTRODUCTION: Although universal drug susceptibility testing (DST) is a component of the End-TB Strategy, over 70% of drug-resistant tuberculosis (DR-TB) cases globally remain undetected. This detection gap reflects difficulties in DST scale-up and substantial heterogeneity in policies and implemented practices. We conducted a systematic review and meta-analysis to assess whether implementation of universal DST yields increased DR-TB detection compared with only selectively testing high-risk groups. METHODS: PubMed, Embase, Global Health, Cochrane Library and Web of Science Core Collection were searched for publications reporting on the differential yield of universal versus selective DST implementation on the proportion of DR-TB, from January 2007 to June 2019. Random-effects meta-analyses were used to calculate respective pooled proportions of DR-TB cases detected; Higgins test and prediction intervals were used to assess between-study heterogeneity. We adapted an existing risk-of-bias assessment tool for prevalence studies. RESULTS: Of 18 736 unique citations, 101 studies were included in the qualitative synthesis. All studies used WHO-endorsed DST methods, and most (87.1%) involved both high-risk groups and the general population. We found only cross-sectional, observational, non-randomised studies that compared universal with selective DST strategies. Only four studies directly compared the testing approaches in the same study population, with the proportion of DR-TB cases detected ranging from 2.2% (95% CI: 1.4% to 3.2%) to 12.8% (95% CI: 11.4% to 14.3%) with selective testing, versus 4.4% (95% CI: 3.3% to 5.8%) to 9.8% (95% CI: 8.9% to 10.7%) with universal testing. Broad population studies were very heterogeneous. The vast majority (88/101; 87.1%) reported on the results of universal testing. However, while 37 (36.6%)/101 included all presumptive TB cases, an equal number of studies applied sputum-smear as a preselection criterion. A meaningful meta-analysis was not possible. CONCLUSION: Given the absence of randomised studies and the paucity of studies comparing strategies head to head, and selection bias in many studies that applied universal testing, our findings have limited generalisability. The lack of evidence reinforces the need for better data to inform policies.

Influence of preoperative magnetic resonance imaging on the surgical management of breast cancer patients.

BACKGROUND: Magnetic resonance imaging (MRI) is gaining popularity in the preoperative management of breast cancer patients. However, the role of this modality remains controversial. We aimed to study the impact of preoperative MRI (pMRI) on the surgical management of breast cancer patients. METHODS: This retrospective study included 766 subjects with breast cancer treated operatively at the specialized academic center. RESULTS: Between those who underwent pMRI (MRI group, n = 307) and those who did not (no-MRI group, n = 458), there were no significant differences (P = .254) in the proportions of either total mastectomies (20.5% vs 17.2%, respectively) or segmental mastectomies (79.5% vs 82.8%). Patients in the MRI group were significantly more likely (P = .002) to undergo contralateral surgery (11.7% vs 5.5%). Similar results were obtained in multivariate analysis adjusting for age, with the proportions of contralateral breast operations significantly higher in the MRI group (Odds Ratio = 2.25, P = .007). pMRI had no significant effect (P = .54) on the proportion of total re-excisions (7.5% vs 8.7%) or the type of re-excision (total vs segmental mastectomy) between the groups. CONCLUSIONS: pMRI does not have a significant impact on the type of operative intervention on the ipsilateral breast but is associated with an increase in contralateral operations. Similarly, pMRI does not change the proportion of re-excisions or the type of the re-excision performed. This study demonstrates that pMRI has little impact on the surgical management of breast cancer, and its value as a routine adjunct in the preoperative work-up of recently diagnosed breast cancer patients needs to be re-examined.