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Assessing tuberculosis management: what really happens to patients?

The End Tuberculosis Strategy, recently launched by WHO1 and focused on the goal of tuberculosis elimination,2 emphasises the role of quality management of the disease. Adequate prevention, diagnosis, and treatment of patients with tuberculosis together form an essential part of the strategy to reduce the incidence of tuberculosis to fewer than one case per 1 million population by 2050. Appropriate strategies for the management of tuberculosis include improved diagnosis and treatment for both active and latent infection and a new effective vaccine for primary prevention.1, 2

The International Standards for Tuberculosis Care (ISTC)3 have been developed to guide clinicians in their daily clinical activities, adapted to different settings.4, 5, 6 However, evidence suggests that the quality of tuberculosis care in high-incidence and low-incidence settings is substandard, both in the private and public sectors.7, 8, 9, 10, 11 The main areas where suboptimal management practices have been described are within diagnosis (ie, late diagnoses that are not based on bacteriological findings), incorrect regimen design (ie, incorrect choice of drug, dose, or duration of treatment), and infection control practices.7, 8, 9, 10, 11

Therefore, to assess if mismanagement of tuberculosis occurs (and to plan accordingly to avoid such mismanagement), an easy-to-use method with high diagnostic accuracy would be very useful. This method should be free from observation bias and recall bias, especially if it is compared with patient interviews. Trained standardised (simulated) patients are one such method that is increasingly used in low-income countries to assess quality of medical care without the need of direct patient assessments and analysis of standard clinical files. India, where the problem of quality of care is especially relevant,9 represents an ideal study setting for the assessment and validation of the use of standardised patients to uncover what really happens to patients with tuberculosis who seek help from a range of different medical providers.

In The Lancet Infectious Diseases, Jishnu Das and colleagues12 present the results of their interesting pilot study undertaken in Delhi, which aimed to validate the standardised patient method for assessment of tuberculosis management. The investigators recruited 100 private providers working in low-income and middle-income urban areas, where large numbers and relative anonymity reduced the probability of the 17 trained standardised patients being recognised as non-genuine. National standards for tuberculosis care (based on ISTC) were used to create four typical cases (two of presumed tuberculosis and one each of confirmed tuberculosis and suspected multidrug-resistant tuberculosis), which the standardised patients presented to a randomly allocated health-care provider working in their usual practice settings (and charging their usual fees). After the clinical interaction, Das and colleagues obtained data using a standardised questionnaire and then compared these with audio files.

The study findings are striking, showing poor adherence to standard of care and variation of quality among providers. Across all cases, only 52 (21% [95% CI 16–26]) of 250 were correctly managed. Correct management was higher among Bachelor of Medicine and Surgery (MBBS)-qualified doctors than other types of health-care provider (adjusted odds ratio 2·41 [95% CI 1·17–4·93]; p=0·0166); however, even conventionally trained MBBS practitioners frequently did not send patients for appropriate tuberculosis-screening tests, despite hearing a typical history from a simulated patient. The results were even more alarming from the providers of alternative medicine and informal services (who see many more patients than MBBS-qualified doctors). Very serious failures of management occurred despite a reasonable theoretical knowledge among many of the participants in the study.

India had 24% of the estimated 9 million patients globally with confirmed tuberculosis in 2013 (ie, 2·0–2·3 million, with an estimated incidence and mortality of 171 and 19 cases per 100 000 population, respectively).13 Although the proportion of patients treated successfully increased between 1995 (25%) and 2012 (88%), a large proportion of cases is still not detected or notified, or both, because of a delay in diagnosis that can be attributed to either the patient or the doctor in the context of a rampant private sector, a situation that Das and colleagues' study presents in a very striking way. Subquality management of tuberculosis is usually noted with cases of multidrug-resistant (MDR) strains of Mycobacterium tuberculosis. More than 50% of the 480 000 new patients with MDR-tuberculosis globally (and 210 000 related deaths) occurred in India, China, and Russia, in 2013.13

On the basis of the findings from Das and colleagues' study,12 and others, the use of standardised patients seems to provide an excellent and realistic insight to the true quality of tuberculosis care at national and subnational level, particularly within the private sector. Furthermore, this method might contribute to improved case-finding and increase the quality of case-detection rate estimates.12 Das and colleagues have clearly underlined the study limitations, which include the urban setting, the focus on the private sector (the public sector needs to also be investigated) and the small sample size. New and more comprehensive studies are necessary to validate the role of this method in other settings and to fully understand its potential to improve the quality of tuberculosis care and the epidemiological estimates of the disease.

References

  1. WHO. International Standards for Tuberculosis Care, 3rd edn. www.istcweb.org. (accessed 26 May 26, 2015).
  2. Migliori, GB, Zellweger, JP, Abubakar, I et al. European Union standards for tuberculosis care. Eur Respir J. 2012; 39: 807–819
  3. Lönnroth, K, Migliori, GB, Abubakar, I et al. Towards tuberculosis elimination: an action framework for low-incidence countries. Eur Respir J. 2015; 45: 928–952
  4. van der Werf, MJ, Sandgren, A, D'Ambrosio, L, Blasi, F, and Migliori, GB. The European Union standards for tuberculosis care: do they need an update?. Eur Respir J. 2014; 43: 933–942
  5. Canadian Thoracic Society and the Public Health Agency of Canada. Canadian Tuberculosis Standards, 7th edn. http://www.respiratoryguidelines.ca/tb-standards-2013; 2013. (accessed May 26, 2015).
  6. Rethans, JJ, Gorter, S, Bokken, L, and Morrison, L. Unannounced standardised patients in real practice: a systematic literature review. Med Educ. 2007; 41: 537–549
  7. Das, J, Hammer, J, and Leonard, K. The quality of medical advice in low-income countries. J Econ Perspect. 2008; 22: 93–114
  8. Sreeramareddy, CT, Qin, ZZ, Satyanarayana, S, Subbaraman, R, and Pai, M. Delays in diagnosis and treatment of pulmonary tuberculosis in India: a systematic review. Int J Tuberc Lung Dis. 2014; 18: 255–266
  9. Migliori, GB, Sotgiu, G, D'Ambrosio, L et al. TB and MDR/XDR-TB in European Union and European Economic Area countries: managed or mismanaged?. Eur Respir J. 2012; 39: 619–625
  10. Sotgiu, G, D'Ambrosio, L, Centis, R et al. TB and M/XDR-TB infection control in European TB reference centres: the Achilles' heel?. Eur Respir J. 2011; 38: 1221–1223
  11. Das, J, Kwan, A, Daniels, B et al. Use of standardised patients to assess quality of tuberculosis care: a pilot, cross-sectional study. Lancet Infect Dis. 2015; (published online Aug 10.)http://dx.doi.org/10.1016/S1473-3099(15)00077-8.
  12. Uplekar, M, Weil, D, Lonnroth, K et al. WHO's new End TB Strategy. Lancet. 2015; 385: 1799–1801
  13. WHO. Global tuberculosis report 2014. World Health Organization, Geneva; 2014 (WHO/HTM/TB2014.08.)


Source: The Lancet Infectious Diseases

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By Giovanni Battista Migliori, Giovanni Sotgiu

Published: Aug. 11, 2015, 8:34 p.m.

Last updated: Aug. 11, 2015, 11:42 p.m.

Tags: TB care

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