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

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.

Funding: Grand Challenges Canada, the Bill & Melinda Gates Foundation, Knowledge for Change Program, and the World Bank Development Research Group.

Conflict of interest statement

Conflicts of interest disclosure:

MP serves as a consultant for the Bill & Melinda Gates Foundation. He has no financial conflicts to disclose. All other authors have no conflicts to disclose.

Copyright © 2015 Elsevier Ltd. All rights reserved.

Figures

Figure 1

Major outcomes, stratified by standardized patient case Notes: For each outcome, SP1 value is on the top; moving downwards, SP4 at bottom. Correct case management for these four cases were defined as:

1. SP1 & SP2: Recommendation for sputum testing or chest X-ray or referral to a public DOTS center/qualified provider

2. SP3: Either referral to a public DOTS center, a qualified private provider or specialist, or (in the case of a qualified private provider) initiation of treatment with standard, 4-drug first-line anti-TB therapy (HRZE regimen)

3. SP4: Recommendation for any drug-susceptibility test (culture/DST, line probe assay or GeneXpert MTB/RIF), or referral to a public DOTS center

CXR: chest x-ray DST: drug-susceptibility testing GeneXpert: Xpert MTB/RIF test (Cepheid Inc, CA)

Figure 2

Proportion of providers who completed history and physical examinations for SP1 cases (N=75 interactions) Notes: SP1 is a standardized patient presenting as a classic case of presumed TB with 2–3 weeks of cough and fever. Each bar in the figure shows the proportion of providers who asked the corresponding question or completed the corresponding examination. For instance, 93% of all providers asked about cough duration and 76% of all providers auscultated the SP.

Figure 3

Impact of provider qualifications on main standardized patient outcomes Notes: Results are reported as adjusted odds ratios for MBBS providers (N=29) relative to non-MBBS (N=71), which includes practitioners of alternative systems of medicine, and informal providers with minimum or no qualifications. Correct case management is defined as a chest x-ray [CXR] or sputum test or referral for SP1 and SP2; as an HRZE regimen or referral for SP3; and a drug-susceptibility test [DST] or GeneXpert or referral for SP4. The antibiotics measure is a lower bound as only identified drugs are included. DST and GeneXpert are excluded from regression because the incidence rate is too low for statistical inference. Regressions are controlled for provider age, provider gender, and caseload on arrival of the SP and SP case and individual fixed effects. *** p