The authors have declared that no competing interests exist.
Conceived and designed the experiments: KSS PI KDS RKB. Performed the experiments: KSS RKB. Analyzed the data: KSS PI RKB MD AD. Contributed reagents/materials/analysis tools: KSS PI RKB MD AD. Wrote the paper: KSS PI KDS RKB MD AD.
One-fifth of the patients on multidrug-resistant tuberculosis treatment at the Drug-Resistant-TB (DR-TB) Site in Gujarat are lost-to-follow-up(LFU).
To understand patients’ and providers' perspectives on reasons for LFU and their suggestions to improve retention-in-care.
Qualitative study conducted between December 2013-March 2014, including in-depth interviews with LFU patients and DOT-providers, and a focus group discussion with DR-TB site supervisors. A thematic-network analysis approach was utilised.
Three sub-themes emerged: (i) Struggle with prolonged treatment; (ii) Strive against stigma and toward support; (iii) Divergent perceptions and practices. Daily injections, pill burden, DOT, migratory work, social problems, prior TB treatment, and adverse drugs effects were reported as major barriers to treatment adherence and retention-in-care by patients and providers. Some providers felt that despite their best efforts, LFU patients remain. Patient movements between private practitioners and traditional healers further influenced LFU.
The study points to a need for repeated patient counselling and education, improved co-ordination between various tiers of providers engaged in DR-TB care, collaboration between the public, private and traditional practitioners, and promotion of social and economic support to help patients adhere to MDR-TB treatment and avoid LFU.
India ranks first among the 27 multidrug-resistant tuberculosis (MDR-TB) high burden countries worldwide, contributing to 21% of all estimated MDR-TB cases [
Studies have recorded high rates of LFU among MDR-TB patients, from 12 to 29% [
In the state of Gujarat, we found nearly 20% of MDR-TB patients are routinely LFU [
The study was approved by the Institutional Ethics Committee for Human Research (IECHR) at Baroda Medical College (Vadodara, India) and the Ethics Advisory Group of the International Union Against Tuberculosis and Lung Disease (Paris, France). Written informed consent was taken from each participant. Patient names were not collected in the study, and all participants were given the freedom to withdraw at any time during the interview. De-identified data was shared with the co-investigators for analysis. The study adhered to COREQ guidelines [
We used a qualitative study design to capture patient and provider experiences with MDR-TB treatment and follow up. Based on our preliminary fieldwork, we determined private in-depth interviews (IDIs) would be best suited to capture the personal experiences of patients and DOT providers, whereas a focus group discussion(FGD) would be more feasible for data collection from district drug-resistant TB (DR-TB) Supervisors.
The study was set at a DR-TB site in Baroda, Gujarat, which was established in February 2010 to initiate and monitor patients on MDR-TB treatment under the endorsement of the Indian Revised National TB Control Programme (RNTCP) [
LFU patients were defined as those patients whose treatment had been interrupted for two or more consecutive months, for any reason [
An FGD was organized among the DR-TB supervisors, who work for the RNTCP and assist the District TB Officer with MDR-TB logistics and in DOT supervision and monitoring of MDR-TB patients belonging to the primary health institution area. IDIs were organized with DOT providers. Supervisors and providers who were unwilling to participate or not available at the time of data collection were excluded.
Data was collected over a period of 4 months, from December 2013 to March 2014. A semi-structured interview questionnaire was used for patient IDIs and a semi-structured topic guide was used for provider IDIs and the FGD. All data was collected by a team of two members including the study PI (lead author), trained in qualitative interviewing, and a highly skilled note-taker, trained in pre-arranged shorthand, in the local vernacular (Gujarati), in a private place that was comfortable for participants. Interviews were not recorded in order to facilitate open and frank discussions. All patients, providers and FGD participants provided their written and informed consent to participate prior to data collection. Minors were accompanied by an adult during the interviews, who also consented to their participation. IDIs lasted 45–60 minutes while the FGD took about1.5 hours.
We utilized thematic network analysis as our framework for analysis, as described by Attride-Stirling [
Of the 36 patients selected purposively for the IDIs, 23 were males. The age of the patients ranged from 13 years to 55 years. Among all patients, 14 were from rural areas, 10 from tribal areas and 8 from urban areas. Three patients had died when they were traced for the interview. One patient was unavailable to participate in the interview due to work. Therefore, IDIs were taken of 32 participants (23 males, 9 females), all of who consented to the study.
The FGD was attended by six DR-TB supervisors. IDIs were conducted with seven DOT providers, who included health care workers and practitioners.
The overarching theme of our qualitative analysis, “Reasons for LFU”, was comprised of the following basic and organizing sub-themes: 1) Struggle with prolonged treatment; 2) Strive against stigma and toward support; and 3) Divergent perceptions and practices.
Patient narratives pointed to a difficult journey with MDR-TB treatment. They reported daily injections, high pill burden, side effects, and the long duration of therapy to be major barriers to adherence. Here are the words of one patient who was frustrated that he was expected to keep adhering to such a long course of injectable treatment:
Providers also felt that the debilitating early adverse events following second-line TB agents, long treatment duration, and injectable drugs daunted patients, and inhibited adherence. But although most providers commiserated with their patients’ perspectives, they also firmly believed in the necessity of treatment.
Long commutes to the DOT clinic and long waiting time in queue for receiving daily medicines were identified as key determinants of treatment interruption. Daily visits interfered with patients’ ability to sustain their routine job/livelihood. Adverse drug effects compelled many patients to take time off work, and suffer further losses in income. When perceived to be intolerable, adverse effects also led to treatment interruptions and discontinuation. Several patients migrated out to other areas for work, making it difficult for them to continue accessing treatment from the DR-TB site.
For example, one patient who had to endure a long daily for his treatment said,
Providers also believed that patients’ prior history with (failed) TB treatment and/or non-adherence were possibly triggers for LFU during their present MDR-TB treatment. As one DOT provider stated,
Provider FGD and patient interviews revealed that retrieval action for LFU patients was generally very difficult:
Stigma, lack of family support, the unfriendly attitude of DOT providers during treatment and retrieval action, and the lack of adequate counseling made it all the more difficult for patients to continue treatment, and in many cases led to LFU.
Although direct acts of discrimination were not reported, patients said they tried to keep their condition as secretive as possible. A diagnosis of MDR-TB could affect their social status within the community, particularly marriage prospects. This appeared to discourage adherence in some women, especially when they failed to receive the support of family members. As one adolescent female patient stated:
In some other patients, however, the fear of being labeled with TB appeared to promote adherence as they were keen to avoid a home visit by a DOT provider, one that could inadvertently expose them as a TB patient in their community. Home visits were routinely conducted as part of the retrieval action for non-adherent patients, but omitted among patients considered to be adherent. As one DOT provider stated:
Many patient participants reported having “unfriendly” or unhelpful DOT providers, which compounded their inclination to interrupt treatment. Some patients stopped treatment when they felt uninformed by their health providers about improvements in their health status and results from medical reports.
The divergent circumstances surrounding a few patients led us to investigate several other factors affecting LFU, notably patient addictions, faith in traditional healers, engagement with private practitioners, and a patronizing attitude toward LFU patients.
Several patients reported suffering from addictions to tobacco or alcohol. These addictions appeared to interfere with their ability to adhere to prescribed MDR-TB therapy in addition to the challenges identified earlier:
Several patients also reported visiting traditional healers and ingesting alternative treatment during MDR-TB therapy, which in some cases led to their discontinuation from conventional treatment.
Patients’ interactions with private providers also influenced their completion of MDR-TB treatment in the public health system, particularly when they were experiencing adverse effects which they were keen to be rid of. A few patients said they had stopped MDR-TB treatment on the order of their private doctors.
Provider participants shared that in some cases, LFU patients seen in the private sector were placed on regimens for drug-susceptible TB. With the reduced pill burden, patients gained a false assurance of being better:
A final subtle theme that emerged from study providers was a collective sentiment that despite their best efforts, patients failed to comply with providers’ advice. Providers strongly expressed that patients needed to listen to their health providers in order to get better.
This study highlights the voices of patient and provider stakeholders attached to a major DR-TB centre in India, and offers a rich source of information about the ground reality for districts dealing with DR-TB in a high-burden, poorly explored region. While qualitative findings may not be easily generalizeable, this study is particularly useful given the paucity of contextualized data on MDR-TB in the Indian sub-context, and the global need to improve retention rates in MDR-TB care.
We have previously reported on clinical and programmatic factors driving LFU in this setting using quantitative methods [
Stigma is understood as contributing to LFU in MDR-TB [
While our study was restricted to the public health sector, patient narratives pointed to incongruence in prescribing practices between practitioners in the public and private sector. Some of our LFU patients, whose treatment was initiated at private clinics, were given drugs that they were already resistant to. The lack of knowledge or poor adherence to programmatic guidelines in TB care has been documented among private practitioners in the region [
In our study, physical improvement after commencing treatment, or the lack of it, both appeared to result in some LFU. Patient education and counselling at the beginning of treatment as well as at periodic intervals is thus essential [
Finally, our study found that MDR-TB patients may be subject to somewhat patronizing interactions within the health system.The idea that patients simply needed to “listen” to their providers was repeated in several interviews, suggesting a relatively paternalistic mindset to service provision (a phenomenon that is increasingly being recognized in the Indian health care system [
Our study had some limitations. The sample was purposive and may not represent the full breadth of experiences among LFU patients and MDR-TB DOT Providers and Supervisors. While our decision to omit using audio-recorders allowed us to create an open environment and capture the most sensitive themes, we lost a degree of data richness. We countered this limitation by being fastidious with note taking during data collection, and document verbatim those narratives expected to be most relevant.
We believe this study has important implications for service delivery in MDR-TB. First, accurate treatment education and counseling provided in a non-judgmental manner, that involves family members and garners their support from the outset, is likely to enhance patients’ commitment to treatment and reduce attrition. It is particularly imperative that we introduce these practices preemptively, before the onset of adverse drug effects, so patients and their family members are armed with correct knowledge before they become naturally inclined to discontinue treatment at the first sign of symptom improvement (or the lack thereof). It is also important that counseling be administered through the full course of treatment, as patients’ circumstances and experiences with medications are likely to change over the 1.5–2 years. Second, in relation to the above point, peer support groups may be effective ways to deliver emotional support and enhance treatment literacy, given that MDR-TB patients in India may lack access to emotional support and empathy within their own homes. The impact of social support and peer groups on LFU may be subsequently studied more objectively. Third, financial support by way of conditional grants or monetary incentives should be explored to encourage long-term retention in MDR-TB care, given patients’ dire socioeconomic circumstances and the public health imperative to reduce transmission of drug-resistant strains within the larger community. Nutrition and transport reimbursements have been associated with lower rates of non-adherence [
This research was conducted through the Structured Operational Research and Training Initiative (SORT IT), a global partnership led by the Special Programme for Research and Training in Tropical Diseases at the World Health Organization (WHO/TDR). The model is based on a course developed jointly by theInternational Union Against Tuberculosis and Lung Disease (The Union) and Médecins sans Frontières. The specific SORT IT programme which resulted in this publication was jointly developed and implemented by: The Union South-East Asia Regional Office, New Delhi, India, the Centre for Operational Research, The Union, Paris, France and Operational Research Unit (LUXOR), Médecins Sans Frontières, Brussels Operational Center, India.
We would like to acknowledge Dr P V Dave, Additional Director Health and State TB Officer, Gujarat, Dr K Pujara, In-charge State TB Officer, Dr A T Leuva, Dean, Medical College Baroda, Dr V S Mazumdar, Head of the Department, Preventive and Social Medicine and Dr K R Patel, Head of the Department, Pulmonary Medicine, Medical College Baroda, Vadodara and Dr Minaxi Chauhan, District TB Officer, Vadodara for their incessant support throughout the study period.