Prediagnostic loss to follow-up in an active case finding tuberculosis programme: a mixed-methods study from rural Bihar, India.

Objective To quantify the prediagnostic loss to follow-up (PDLFU) in an active case finding tuberculosis (TB) programme and identify the barriers and enablers in undergoing diagnostic evaluation. Design Explanatory mixed-methods design. Setting A rural population of 1.02 million in the Samastipur district of Bihar, India. Participants Based on their knowledge of health status of families, community health workers or CHWs (called accredited social health activist or locally) and informal providers referred people to the programme. The field coordinators (FCs) in the programme screened the referrals for TB symptoms to identify presumptive TB cases. CHWs accompanied the presumptive TB patients to free diagnostic evaluation, and a transport allowance was given to the patients. Thereafter, CHWs initiated and supported the treatment of confirmed cases. We included 13 395 community referrals received between January and December 2018. To understand the reasons of the PDLFU, we conducted in-depth interviews with patients who were evaluated (n=3), patients who were not evaluated (n=4) and focus group discussions with the CHWs (n=2) and FCs (n=1). Outcome measures Proportion and characteristics of PDLFU and association of demographic and symptom characteristics with diagnostic evaluation. Results A total of 11 146 presumptive TB cases were identified between January and December 2018, out of which 4912 (44.1%) underwent diagnostic evaluation. In addition to the free TB services in the public sector, the key enablers were CHW accompaniment and support. The major barriers identified were misinformation and stigma, deficient family and health provider support, transport challenges and poor services in the public health system. Conclusion Finding the missing cases will require patient-centric diagnostic services and urgent reform in the health system. A community-oriented intervention focusing on stigma, misinformation and patient support will be critical to its success.

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204 Manual descriptive content analysis was performed by two independent, trained researchers 205 (TG, DS) to generate categories and themes.
[23] Any discrepancies between the two were 206 resolved through discussion. These were discussed and reviewed by RM to avoid subjective bias.
207 The codes and themes were related back to the original data to ensure that the results reflect 208 the data. [24] 209 patient and public involvement 210 Patients were neither involved in the study design nor in the interpretation of patient relevant 211 outcomes. Nonetheless, patient's views were sought in the qualitative interviews and included 212 in the results. The results of this study will be communicated to the patients and the public 213 through a newsletter in the vernacular.

RESULTS
215 care cascade and characteristics of presumptive TB cases 216 We received a total of 13395 community referrals, out of which 90.9% (n=12180) were screened 217 for symptoms. Of those screened, 91.5% (n=11146) were presumptive TB cases, and referred for 218 a diagnostic evaluation. (Figure 2) 219 There was nearly equal representation of presumptive TB cases from all the 3 blocks, and ASHAs 220 identified most of them (75.6%). The mean age of presumptive TB cases was 35 years with 221 majority in the 15-44 age group (41.8%). There were more males (52.2%) than females. (Table 1) 222  On multivariate analysis, presumptive TB cases who were between 15 to 44 235 years of age (aRR 0.9, 95% CI: 0.9 -1.0, p = 0) were more likely to be LFU in the pre-diagnostic 236 stage. All of the clinical features of presumptive TB were also associated with lower LFU except 237 lymph node swelling. Alcohol use was an independent risk factor for LFU (aRR 1.2, 95% CI: 1.1 -238 1.4, p = 0.01). The median time to diagnosis was 1 day (IQR = 3). (Table 2) 239 Enablers to access the first diagnostic evaluation   According to patients, the care at PHC was slow and took a lot of time. They said either the PHC 287 remained closed or they didn't reach the PHC in working hours. At other times when they 288 reached, the providers were not available at the facility.

COREQ (COnsolidated criteria for REporting Qualitative research) Checklist
A checklist of items that should be included in reports of qualitative research. You must report the page number in your manuscript where you consider each of the items listed in this checklist. If you have not included this information, either revise your manuscript accordingly before submitting or note N/A. 9, 10 8 9, 10 9, 10 9, 10 9 5 -7, 9 Not Applicable