SUMMARY Background Existing studies on quality of tuberculosis care mostly reflect knowledge, not actual practice. Methods We conducted a validation study on the use of standardized patients (SPs) for assessing quality of TB care. Four cases, two for presumed TB and one each for confirmed TB and suspected MDR-TB, were presented by 17 SPs, with 250 SP interactions among 100 consenting providers in Delhi, including qualified (29%), alternative medicine (40%) and informal providers (31%). Validation criteria were: (1) negligible risk and ability to avoid adverse events for providers and SPs; (2) low detection rates of SPs by providers, and (3) data accuracy across SPs and audio verification of SP recall. We used medical vignettes to assess provider knowledge for presumed TB. Correct case management was benchmarked using Standards for TB Care in India (STCI). Findings SPs were deployed with low detection rates (4.7% of 232 interactions), high correlation of recall with audio recordings (r=0.63; 95% CI: 0.53 – 0.79), and no safety concerns. Average consultation length was 6 minutes with 6.2 questions/exams completed, representing 35% (95% confidence interval [CI]: 33%–38%) of essential checklist items. Across all cases, only 52 of 250 (21%; 95% CI: 16%–26%) were correctly managed. Correct management was higher among MBBS doctors (adjusted OR=2.41, 95% CI: 1.17–4.93) as compared to all others. Provider knowledge in the vignettes was markedly more consistent with STCI than their practice. Interpretation The SP methodology can be successfully implemented to assess TB care. Our data suggest a big gap between provider knowledge and practice.

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 PLOS MEDICINE

SummaryBackgroundIndia'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.MethodsIn 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.FindingsBetween 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.InterpretationOnly 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.FundingGrand Challenges Canada, Bill & Melinda Gates Foundation, Knowledge for Change Program, and World Bank Development Research Group.

BackgroundIndia 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.Methods and findingsDuring 2014–2017, pilot programs engaged the private health sector to improve TB management in Mumbai and Patna. Nested within these projects, to obtain representative, baseline measures of quality of TB care at the city level, we recruited 24 adults to be SPs. They were trained to portray 4 TB “case scenarios” representing various stages of disease and diagnostic progression. Between November 2014 and August 2015, the SPs visited representatively sampled private providers stratified by qualification: (1) allopathic providers with Bachelor of Medicine, Bachelor of Surgery (MBBS) degrees or higher and (2) non-MBBS providers with alternative medicine, minimal, or no qualifications.Our main outcome was case-specific correct management benchmarked against the Standards for TB Care in India (STCI). Using ANOVA, we assessed variation in correct management and quality outcomes across (a) cities, (b) qualifications, and (c) case scenarios. Additionally, 2 micro-experiments identified sources of variation: first, quality in the presence of diagnostic test results certainty and second, provider consistency for different patients presenting the same case.A total of 2,652 SP–provider interactions across 1,203 health facilities were analyzed. Based on our sampling strategy and after removing 50 micro-experiment interactions, 2,602 interactions were weighted for city-representative interpretation. After weighting, the 473 Patna providers receiving SPs represent 3,179 eligible providers in Patna; in Mumbai, the 730 providers represent 7,115 eligible providers. Correct management was observed in 959 out of 2,602 interactions (37%; 35% weighted; 95% CI 32%–37%), primarily from referrals and ordering chest X-rays (CXRs). Unnecessary medicines were given to nearly all SPs, and antibiotic use was common. Anti-TB drugs were prescribed in 118 interactions (4.5%; 5% weighted), of which 45 were given in the case in which such treatment is considered correct management.MBBS and more qualified providers had higher odds of correctly managing cases than non-MBBS providers (odds ratio [OR] 2.80; 95% CI 2.05–3.82; p < 0.0001). Mumbai non-MBBS providers had higher odds of correct management than non-MBBS in Patna (OR 1.79; 95% CI 1.06–3.03), and MBBS providers’ quality of care did not vary between cities (OR 1.15; 95% CI 0.79–1.68; p = 0.4642). In the micro-experiments, improving diagnostic certainty had a positive effect on correct management but not across all quality dimensions. Also, providers delivered idiosyncratically consistent care, repeating all observed actions, including mistakes, approximately 75% of the time. Th...

IntroductionThe quality of clinical care can be reliably measured in multiple settings using standardised patients (SPs), but this methodology has not been extensively used in Sub-Saharan Africa. This study validates the use of SPs for a variety of tracer conditions in Nairobi, Kenya, and provides new results on the quality of care in sampled primary care clinics.MethodsWe deployed 14 SPs in private and public clinics presenting either asthma, child diarrhoea, tuberculosis or unstable angina. Case management guidelines and checklists were jointly developed with the Ministry of Health. We validated the SP method based on the ability of SPs to avoid detection or dangerous situations, without imposing a substantial time burden on providers. We also evaluated the sensitivity of quality measures to SP characteristics. We assessed quality of practice through adherence to guidelines and checklists for the entire sample, stratified by case and stratified by sector, and in comparison with previously published results from urban India, rural India and rural China.ResultsAcross 166 interactions in 42 facilities, detection rates and exposure to unsafe conditions were both zero. There were no detected outcome correlations with SP characteristics that would bias the results. Across all four conditions, 53% of SPs were correctly managed with wide variation across tracer conditions. SPs paid 76% less in public clinics, but proportions of correct management were similar to private clinics for three conditions and higher for the fourth. Kenyan outcomes compared favourably with India and China in all but the angina case.ConclusionsThe SP method is safe and effective in the urban Kenyan setting for the assessment of clinical practice. The pilot results suggest that public providers in this setting provide similar rates of correct management to private providers at significantly lower out-of-pocket costs for patients. However, comparisons across countries are sensitive to the tracer condition considered.

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.

IntroductionDetermining 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.MethodsSecondary 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.ResultsAcross 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%).ConclusionGood-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.

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