--Eleven tips for operational researchers working with health programmes: our experience based on implementing differentiated tuberculosis care in south India.

Due to the workload and lack of a critical mass of trained operational researchers within their ranks, health systems and programmes may not be able to dedicate sufficient time to conducting operational research (OR). Hence, they may need the technical support of operational researchers from research/academic organisations. Additionally, there is a knowledge gap regarding implementing differentiated tuberculosis (TB) care in programme settings. In this 'how we did it' paper, we share our experience of implementing a differentiated TB care model along with an inbuilt OR component in Tamil Nadu, a southern state in India. This was a health system initiative through a collaboration of the State TB cell with the Indian Council of Medical Research institutes and the World Health Organisation country office in India. The learnings are in the form of eleven tips: four broad principles (OR on priority areas and make it a health system initiative, implement simple and holistic ideas, embed OR within routine programme settings, aim for long-term engagement), four related to strategic planning (big team of investigators, joint leadership, decentralised decision-making, working in advance) and three about implementation planning (conducting pilots, smart use of e-tools and operational research publications at frequent intervals). These may act as a guide for other Indian states, high TB burden countries that want to implement differentiated care, and for operational researchers in providing technical assistance for strengthening implementation and conducting OR in health systems and programmes (TB or other health programmes). Following these tips may increase the chances of i) an enriching engagement, ii) policy/practice change, and iii) sustainable implementation.

Completion Rates and Clinical Changes of Patients Seeking Non-Invasive Treatment for Low Back Pain in 13 Centres of a Sports Medicine Institute in India.

BACKGROUND/AIM: Low back pain (LBP) is the major cause of disability worldwide. The existing treatments are expensive and associated with complications. The present study aimed to determine the proportion of patients completing therapy and rehabilitation phases and describe the changes in self-reported symptoms and functional disability among LBP patients enrolled in a private sports medicine institute. METHODS: This is a cohort study involving review of case records. We studied 2 phases out of 3 of non-invasive treatment of LBP: therapy of around 10 days (myofascial trigger point release therapy, cryotherapy, aqua therapy and acupuncture) and rehabilitation of around 3 weeks (muscle strengthening exercises). RESULTS: A total of 443 patients were enrolled; their mean (SD) age was 46 (15) years, 46% were male, and 193 (44%) presented with chronic (>6 months) pain. The numbers of patients who completed the therapy and rehabilitation phases were 327 (74%) and 115 (26%), respectively. The median (IQR) visual analogue scale pain scores were 7 (6-9) at entry, 2 (1-3) at completion of therapy and 1 (0-2) at completion of rehabilitation (p < 0.001). The median (IQR) functional disability scores were 32 (22-53) at entry, 15 (6-26) at completion of therapy and 4 (0-14) at completion of rehabilitation (p < 0.001). CONCLUSION: Low completion rates were observed. Patients who completed therapy reported reduction in pain and improved functionalities.

Attrition and delays before treatment initiation among patients with MDR-TB in China (2006-13): Magnitude and risk factors.

BACKGROUND: China's national tuberculosis programme does not have cohort wise information regarding attrition and delays in the multidrug resistant tuberculosis (MDR-TB) diagnosis and treatment pathway. OBJECTIVE: Under the Global Fund programmatic management of drug-resistant TB (2006-13), we assessed the attrition and delay in the pathway and the factors associated. METHODS: Cohort study involving secondary programme data. All patients identified as presumptive MDR-TB (defined as i) previously treated TB patients which included recurrent TB, return after loss to follow up, treatment after failure and ii) new TB patients that were non-converters at three months of treatment or in close contact with a known MDR-TB patient) during October 2006 to June 2013 were eligible for phenotypic drug susceptibility testing (DST). Pre-diagnosis attrition (presumptive MDR-TB not undergoing culture and DST) and pre-treatment attrition (confirmed MDR-TB patients not initiated on treatment) was calculated. Diagnosis delay was the time interval from DST eligibility to DST result, treatment initiation delay was fom DST result to treatment initiation and total delay was from DST eligbility to treatment initiation. Factors associated with attrition and delay were identified using log binomial regression and linear regression, respectively. RESULTS: Of 78 564 presumptive MDR-TB patients, 2 470 (3.1%) underwent pre-diagnosis attrition. Of 9 283 MDR-TB patients, 3 361 (36.2%) underwent pre-treatment attrition. Median(IQR) diagnosis delay was 84 (64, 114) days; treatment initation delay was 23(6,68) days and total delay was 117(77,187) days. Long diagnosis delay was an independent predictor of pre-treatment attrition in a dose response relationship. While pre-treatment attrition was less likely among presumptive criterion 'previously treated' and with increasing time period, it was more likey among elderly and in east and west region. While the diagnosis delay increased with time period, treatment initiation delay and total delay reduced with time period. Short diagnosis delay was associated with west region, smear negative patients and presumptive criterion 'treatment after lost to follow up'. Short treatment initiation delay was associatied with east and west regions while long treatment initiation delay was associated with elderly and presumptive criterion 'recurrent TB'. Total delay predictors were similar to treatment initiation delay. In addition, short total delay was associated with presumptive criterion 'treatment after failure'. CONCLUSION: The diagnosis and treatment delay were long and the pre-treatment attrition was considerable high. Long diagnosis delay is likely to predict pre-treatment attrition.

Patient characteristics, health seeking and delays among new sputum smear positive TB patients identified through active case finding when compared to passive case finding in India.

BACKGROUND: Axshya SAMVAD is an active tuberculosis (TB) case finding (ACF) strategy under project Axshya (Axshya meaning 'free of TB' and SAMVAD meaning 'conversation') among marginalized and vulnerable populations in 285 districts of India. OBJECTIVES: To compare patient characteristics, health seeking, delays in diagnosis and treatment initiation among new sputum smear positive TB patients detected through ACF and passive case finding (PCF) under the national TB programme in marginalized and vulnerable populations between March 2016 and February 2017. METHODS: This observational analytic study was conducted in 18 randomly sampled Axshya districts. We enrolled all TB patients detected through ACF and an equal number of randomly selected patients detected through PCF in the same settings. Data on patient characteristics, health seeking and delays were collected through record review and patient interviews (at their residence). Delays included patient level delay (from eligibility for sputum examination to first contact with any health care provider (HCP)), health system level diagnosis delay (from contact with first HCP to TB diagnosis) and treatment initiation delays (from diagnosis to treatment initiation). Total delay was the sum of patient level, health system level diagnosis delay and treatment initiation delays. RESULTS: We included 234 ACF-diagnosed and 231 PCF-diagnosed patients. When compared to PCF, ACF patients were relatively older (≥65 years, 14% versus 8%, p = 0.041), had no formal education (57% versus 36%, p<0.001), had lower monthly income per capita (median 13.1 versus 15.7 USD, p = 0.014), were more likely from rural areas (92% versus 81%, p<0.002) and residing far away from the sputum microscopy centres (more than 15 km, 24% versus 18%, p = 0.126). Fewer patients had history of significant loss of weight (68% versus 78%, p = 0.011) and sputum grade of 3+ (15% versus 21%, p = 0.060). Compared to PCF, HCP visits among ACF patients was significantly lower (median one versus two HCPs, p<0.001). ACF patients had significantly lower health system level diagnosis delay (median five versus 19 days, p = 0.008) and the association remained significant after adjusting for potential confounders. Patient level and total delays were not significantly different. CONCLUSION: Axshya SAMVAD linked the most impoverished communities to TB care and resulted in reduction of health system level diagnosis delay.

What happens to migrant tuberculosis patients who are transferred out using a web-based system in China?

BACKGROUND: In China, internal migrants constitute one-fifth of tuberculosis (TB) patients registered for treatment in web-based TB information management system (TBIMS). Though China added a specific module in the web-based TBIMS in 2009, web-based transfer-out is not specifically recommended in the national guidelines. OBJECTIVE: In this country wide study among all registered migrant TB patients (2014-2015) that were transferred out using web-based TBIMS in China, to determine the i) timing of transfer-out in relation to period of treatment; ii) delay and attrition during transfer interval (between transfer-out and transfer-in); and iii) extent and risk factors for 'not evaluated' as the treatment outcome. METHODS: This was a cohort study involving review of web-based TBIMS data. Modified Poisson regression was used to build a predictive model for risk factors of 'not evaluated' as the treatment outcome. RESULTS: Among 7 284 patients, 5 900 (81.0%) were transferred out during the first two months after initiation of treatment or before treatment initiation and 7 088 (97.3%) patients had arrived at transfer-in unit. The median transfer interval was three (interquartile range: 0-14) days. Sixteen percent (1 176/7 284) patients had 'not evaluated' as their treatment outcome. 'Not evaluated' contributed to 66% of the unfavourable outcomes. Patients transferred from referral hospitals, migrated from out of prefecture, transferred out of prefecture, with sputum smear negative pulmonary TB, with TB pleurisy and with long delay between symptom onset and treatment initiation had significantly higher risk of 'not evaluated' as the outcome. CONCLUSION: Web-based transfer helped as the delay and attrition during the transfer interval was quite short and treatment outcomes of more than four-fifths of transferred out migrant TB patients were available with transfer-out BMU. Once strategies to address the independent predictors of 'not evaluated' treatment outcome are devised, China may consider mandatory use of web-based TBIMS for transferring out migrant TB patients.

Delay before drug susceptibility testing among patients with presumptive multidrug-resistant tuberculosis in Gujarat, India.

Background: Reducing delay in the diagnosis of multidrug-resistant tuberculosis (MDR-TB) by performing genotypic drug susceptibility testing (DST) among eligible patients as early as possible can improve clinical presentation and treatment outcomes and reduce transmission. We aimed to determine the delay from being eligible for DST to performing DST and factors associated with the delay. Methods: This was a retrospective cohort study involving record review among presumptive MDR-TB patients who underwent genotypic DST from five selected districts in the state of Gujarat, India (2014). Specimens were couriered from the designated microscopy centres (DMCs) to two designated genotypic DST facilities located outside the districts. Results: Of 2212 patients, the median duration from eligibility to the specimen being sent, from the specimen being sent to DST and from eligibility to DST was 3, 5 and 8 d, respectively. Patients from DMCs in teaching hospitals and with presumptive MDR-TB criteria 'follow-up smear positive' and 'TB-human immunodeficiency virus co-infection' had a significantly higher risk of delay between eligibility and testing (≥8 d). The delay in the specimen being sent after eligibility contributed to high delays in these subgroups. Conclusion: The districts were doing well in implementing timely DST among presumptive MDR-TB patients. However, there is room for improvement in reducing the delays in the sending of specimens among certain patient subgroups.