Issue: October 2015
September 10, 2015
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Simulated patient visits in India show low adherence to TB guidelines

Issue: October 2015
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Standardized patient evaluations of tuberculosis care in India revealed a low level of compliance by health care providers with established guidelines, according to recent findings from a pilot study published in Lancet Infectious Diseases.

Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre at McGill University, and colleagues recruited 17 apparently healthy individuals in Delhi, India, between Feb. 2 and March 28, 2014, to act as standardized patients for 100 private outpatient health care providers in low-and middle-income areas of the city. According to Pai and colleagues, this method of assessing the quality of medical care is free from observation bias and less susceptible to recall bias than patient exit interviews. The patients were intensively screened and trained over a 3-week period to portray four different cases — two of presumed TB and one each of confirmed TB and suspected multidrug-resistant TB.

Twenty-nine practitioners were qualified in allopathic medicine, 40 practiced alternative medicine, and 31 were informal providers with little or no qualifications. They were told that in the ensuing 6 months, they may encounter someone in their practice who is a sham patient, and were asked to record the name and date of the visit of any patient they suspected not to be genuine. Within 1 hour of each encounter, standardized patients completed a questionnaire detailing what each provider had done during the visit.

The medical manifestations of each scenario were enhanced with psychosocial aspects of TB presentation in the community, the researchers said. These “tuberculosis scripts” were created by social scientists in collaboration with the standardized patients to simplify and clarify the diagnosis. The researchers evaluated quality of care based on the providers’ compliance with case-specific checklists of recommended care, the suitability of treatments, and the implementation of extraneous or contraindicated therapies, such as steroids. Correct case management was assessed according to the Standards for Tuberculosis Care in India (STCI).

Pai and colleagues found that there was a low percentage of detection of standardized patients; 11 (5%) were detected by providers out of 232 interactions. No safety concerns were cited. The mean duration of consultation was 6 minutes (95% CI, 5.5-6.6), with a mean of 6.18 (95% CI, 5.72-6.64) questions or examinations carried out — representing 35% (95% CI, 33-38) of the essential checklist items. The researchers also found, however, that of the 250 standardized patient cases, only 21% (95% CI, 16-26) were managed appropriately.

MBBS-qualified doctors had higher rates of correct case management vs. other types of providers (adjusted OR = 2.41; 95% CI, 1.17-4.93).

Sixty-nine providers also were given a medical vignette to assess their knowledge of presumed TB, the answers from which aligned more closely with STCI guidelines than was observed in clinical practice. For example, 73% of providers ordered chest radiographs or sputum tests during the vignette, compared with only 10% during interactions with standardized patients (OR = 0.04; 95% CI, 0.02-0.11).

The researchers said these findings suggest low compliance with established guidelines for tuberculosis care, despite a high level of knowledge.

“Previously published data and our results show a big gap between what health care providers know about tuberculosis, and what they actually do in their clinical practice,” the researchers wrote. “Future iterations of the standardized-patient method might help with the design of programs to control tuberculosis, and monitoring and assessment of indicators for quality of tuberculosis care.” – by Jen Byrne

Disclosure: Pai reports being a consultant for the Bill & Melinda Gates Foundation. Another researcher is funded by the NIH. The other authors report no relevant financial disclosures.