Challenges and Strategic Solutions to Guarantee Last Mile Reach for an Indian TB Patient's Nikshay Poshan Yojana; A Conditional Cash Transfer Scheme Comment on "Does Direct Benefit Transfer Improve Outcomes Among People With Tuberculosis? - A Mixed-Methods Study on the Need for a Review of the Cash Transfer Policy in India".

India has put efforts into the prevention and control of tuberculosis (TB) for more than 50 years. Nikshay Poshan Yojna (NPY) is one of the schemes of conditional cash transfers (CCTs) by the Government of India. The CCT schemes mostly address the demand side constraints. Governments could use this in developing nations as a tool to divert financial resources toward societal development. In India, NPY is more directed toward providing monetary support for a nutritional diet and reducing the catastrophic expenditure of TB patients. Several studies highlighted challenges in implementing cash transfer schemes and provided different operational models. A country like India should address the challenges with defined strategies to ensure its last-mile reach. A present commentary discussing challenges and possible solutions that policy-makers can adapt and set up a support structure to ensure that supportive actions are implemented in response to patient and system side issues.

Capacity Building, Knowledge Enhancement, and Consultative Processes for Development of a Digital Tool (Ni-kshay SETU) to Support the Management of Patients with Tuberculosis: Exploratory Qualitative Study.

BACKGROUND: Achieving the target for eliminating tuberculosis (TB) in India by 2025, 5 years ahead of the global target, critically depends on strengthening the capacity of human resources as one of the key components of the health system. Due to the rapid updates of standards and protocols, the human resources for TB health care suffer from a lack of understanding of recent updates and acquiring necessary knowledge. OBJECTIVE: Despite an increasing focus on the digital revolution in health care, there is no such platform available to deliver the key updates in national TB control programs with easy access. Thus, the aim of this study was to explore the development and evolution of a mobile health tool for capacity building of the Indian health system's workforce to better manage patients with TB. METHODS: This study involved two phases. The first phase was based on a qualitative investigation, including personal interviews to understand the basic requirements of staff working in the management of patients with TB, followed by participatory consultative meetings with stakeholders to validate and develop the content for the mobile health app. Qualitative information was collected from the Purbi Singhbhum and Ranchi districts of Jharkhand and Gandhinagar, and from the Surat districts of Gujarat State. In the second phase, a participatory design process was undertaken as part of the content creation and validation exercises. RESULTS: The first phase collected information from 126 health care staff, with a mean age of 38.4 (SD 8.9) years and average work experience of 8.9 years. The assessment revealed that more than two-thirds of participants needed further training and lacked knowledge of the most current updates to TB program guidelines. The consultative process determined the need for a digital solution in easily accessible formats and ready reckoner content to deliver practical solutions to address operational issues for implementation of the program. Ultimately, the digital platform named Ni-kshay SETU (Support to End Tuberculosis) was developed to support the knowledge enhancement of health care workers. CONCLUSIONS: The development of staff capacity is vital to the success or failure of any program or intervention. Having up-to-date information provides confidence to health care staff when interacting with patients in the community and aids in making quick judgments when handling case scenarios. Ni-kshay SETU represents a novel digital capacity-building platform for enhancing human resource skills in achieving the goal of TB elimination.

Why and where?-Delay in Tuberculosis care cascade: A cross-sectional assessment in two Indian states, Jharkhand, Gujarat.

Tuberculosis (TB) is the second leading cause of death due to infectious diseases globally, and delay in the TB care cascade is reported as one of the major challenges in achieving the goals of the TB control programs. The main aim of this study was to investigate the delay and responsible factors for the delay in the various phases of care cascade among TB patients in two Indian states, Jharkhand and Gujarat. This cross-sectional study was conducted among 990 TB patients from the selected tuberculosis units (TUs) of two states. This study adopted a mixed-method approach for the data collection. The study targeted a diverse profile of TB patients, such as drug-sensitive TB (DSTB), drug resistance TB (DRTB), pediatric TB, and extra-pulmonary TB. It included both public and private sector patients. The study findings suggested that about 41% of pulmonary and 51% of extra-pulmonary patients reported total delay. Delay in initial formal consultation is most common, followed by a delay in diagnosis and treatment initiation in pulmonary patients. While in extra-pulmonary patients, delay in treatment initiation is most common, followed by the diagnosis and first formal consultation. DR-TB patients are more prone to total delay and delay in the treatment initiation among pulmonary patients. Addiction, co-morbidity and awareness regarding monetary benefits available for TB patients contribute significantly to the total delay among pulmonary TB patients. There were system-side factors like inadequacy in active case findings, poor infrastructure, improper adverse drug reaction management and follow-up, resulting in delays in the TB care cascade in different phases. Thus, the multi-disciplinary strategies covering the gambit of both system and demand side attributes are recommended to minimize the delays in the TB care cascade.

Bayesian statistical approaches to drug product variability assessment and release.

The determination of the variability of critical dosage form attributes has been a challenge in establishing the quality of pharmaceutical products. During the development process knowledge is minimal. Consequently, ad hoc statistical tools such as hypothesis or significance tests, with calibrated decision error rates are often used in an effort to vet CQAs (Critical Quality Attributes) and keep their levels "between the curbs". As progress moves towards product launch, process and mechanistic understanding grows considerably and there are opportunities to leverage that knowledge for predictive modeling. Bayesian models offer a coherent strategy for integrating prior knowledge into both experimental design as well as predictive analysis for optimal risk-based decision making. This is because the Bayesian paradigm, unlike the frequentist paradigm, can assign probabilities to underlying states of nature that directly impact safety and efficacy such as the population distribution of tablet potencies or dissolution profiles in a batch. However, there are challenges and reluctance in switching to a predictive modeling quality framework once regulatory approval has been attained. This paper offers encouragement to make this switch. In this paper, we review a joint Long Island University - Purdue University (LIU-PU) FDA funded project whose purpose was to further integrate the concepts of this adaptive approach to lot release with the rationale and methods for data generation and curation and to extend the testing of this approach. We discuss the utility of the approach in product development. We consider the regulatory compliance implications, with examples, and establish a potential way forward toward implementation of this approach for both industry and regulatory stake-holders.

Assessment of Salivary Mutans Streptococci Counts to Atraumatic Restorative Treatment Among Children: A Randomised Controlled Trial.

Introduction Besides the survival rate of restorations, the effect of atraumatic restorative treatment (ART) on bacterial count is also important. After ART restoration, the bacterial count drops due to the fluoride's antibacterial activity and hence it can decrease the chances of further decay. The present study assessed salivary mutans streptococci counts for six months of evaluations subsequent to ART among 12-15-year-old children attending schools in Piparia village, Vadodara district. Methods ART was performed on 32 children and followed up after six months to evaluate the success rate of ART. Saliva collection and microbial analysis were performed five times from every participant, before ART restoration placement, seven days, 30 days (one month), 90 days (three months) and 180 days (six months) post-restoration. Results At baseline, the mean colony forming units (CFU) was 48.30 ± 46.58, which reduced to 32.64 ± 30.40 at one week, which showed a 32% reduction in colony counts. This further reduced to 18.60 ± 20.81 at one month, marking a further 43% reduction in colony counts. This again reduced to 13.63 ± 18.04 at three months, which showed a 27% reduction in colony counts. CFU came to 16.23 ± 23.34 at six months, which showed a 19% increase in colony counts. Comparison of baseline mean CFU (48.30 ± 46.58) to six months mean CFU of streptococcus mutans (SM) (16.23 ± 23.34) showed a 66% reduction in colony counts. A statistically significant difference was found between numerous intervals of time of CFU of streptococcus mutans. Conclusion The findings reveal that ART is a clinical treatment that can be used to treat caries in young children, and it helped significantly reduce Streptococcus Mutans levels in saliva.

Similarity of dissolution profiles from biorelevant media: Assessment of interday repeatability, interanalyst repeatability, and interlaboratory reproducibility using ibuprofen and ketoconazole tablets.

Biorelevant media are increasingly being employed as dissolution media in drug development, including in smaller volumes than 900ml and under non-sink conditions. The objectives were to assess interday repeatability, interanalyst repeatability, and interlaboratory reproducibility of dissolution profiles from biorelevant media, as well as to assess the impacts of biorelevant media production method and biorelevant medium volume on dissolution profiles. Ibuprofen and ketoconazole tablets were subjected to dissolution testing in 500ml, 300ml, and 40ml of fasted state simulated gastric fluid (FaSSGF), fed state simulated gastric fluid (FeSSGF), fasted state simulated intestinal fluid version 2 (FaSSIF-V2), and fed state simulated intestinal fluid version 2 (FeSSIF-V2). f2 was used to assess repeatability and reproducibility of dissolution profiles. Results indicate favorable interday repeatability (83 of 88 comparisons were similar), favorable interanalyst repeatability (19 of 21 comparisons were similar), and favorable interlaboratory reproducibility (10 of 14 comparisons were similar) of dissolution profiles from biorelevant media, with commercial media showing greater interlaboratory reproducibility than 'from scratch' media. However, biorelevant medium production had low impact on profiles when one analyst conducted all medium preparations and study procedures at one location. Additionally, biorelevant media detected differences when products were not similar. Overall, biorelevant media showed favorable repeatability and reproducibility performance.

Heterogeneity of Treatment and Outcomes Among Asians With Coronary Artery Disease in the United States.

Background Prior data demonstrate significant heterogeneity regarding coronary artery disease risk factors and outcomes among Asians in the United States, but no studies have yet examined coronary artery disease treatment patterns or outcomes among disaggregated Asian American subgroups. Methods and Results From a total of 772 882 patients with known race/ethnicity and sex who received care from a mixed-payer healthcare organization in Northern California between 2006 and 2015, a retrospective analysis was conducted on 6667 adults with coronary artery disease. Logistic regression was used to examine medical and procedural therapies and outcomes by race/ethnicity, with adjustment for age, sex, income, and baseline comorbidities. Compared with non-Hispanic whites, Chinese were more likely to undergo stenting (50.9% versus 60.8%, odds ratio [OR] 1.39 [95% CI, 1.04-1.87], p=0.005), whereas Filipinos were more likely to receive bypass surgery (6.9% versus 20.5%, OR 2.65 [95% CI, 1.75-4.01], P<0.0001). After stenting, Chinese, Filipinos, and Japanese were more likely than non-Hispanic whites to be prescribed clopidogrel (86.2%, 83.0%, and 91.4% versus 74.5%, ORs 1.86 [95% CI, 1.13-3.04], 1.86 [95% CI, 1.01-3.44], and 4.37 [95% CI, 1.02-18.67], respectively, P<0.0001). Lastly, Chinese and Asian Indians were more likely than non-Hispanic whites to be diagnosed with a myocardial infarction within 1 year postangiography (15.6% and 17.4% versus 11.2%, ORs 1.49 [95% CI, 1.02-2.19] and 1.68 [95% CI, 1.21-2.34], respectively, P<0.0001). Conclusions Disaggregation of Asian Americans with coronary artery disease into individual racial/ethnic subgroups reveals significant variability in treatment patterns and outcomes. Further investigation into these differences may expose important opportunities to mitigate disparities and improve quality of care in this diverse population.

The Association Of Race With Outcomes Among Parturients Undergoing Cesarean Section With Perioperative Epidural Catheter Placement: A Nationwide Analysis.

BACKGROUND: In obstetrical health care, disparities have been documented in different aspects of maternal care and outcomes. Prior epidemiological studies have shown that labor analgesia is underused in African-American and Hispanic groups, which means there may be inadequate labor pain control in these groups. Differences in usage have been attributed primarily to insurance, educational levels and perceptional influences such as fear of paralysis and chronic low back pain. In cesarean section deliveries, race and ethnicity affect the choice of anesthesia considered. How race and ethnicity affect maternal outcomes in cesarean sections with epidural placements generally has been unexplored. Disparities in health care utilization are shown to contribute to the disparities in health outcomes. METHODS: This is a retrospective analysis using data from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project (AHRQ-HCUP), the National Inpatient Sample (NIS) database from January 2003 to December 2013, which is a 20% stratified sample of the nonfederal hospitals in the United States. Women undergoing cesarean section (International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) procedure codes 74.0, 74.1, 74.2, 74.4, 74.99) with perioperative epidural catheter placement (ICD-9-CM procedure codes 3.90, 3.91) were included for analysis. RESULTS: The final cohort used for analysis included 87,076 patients. There were significant differences in the distribution of patient characteristics across the race groups. The majority of health care coverage for Caucasians and Asians was private insurance, while for African-American, Hispanic and Native American was Medicare and Medicaid. Almost all the examined comorbid conditions were statistically significant and highest in the African-American group, including hypertension, obesity, diabetes, and renal failure, except for congestive heart failure that was highest in the Asian group. Cesarean sections took place mostly in an urban teaching hospital across all groups. Discharge to home was the predominant destination after recovery. The mean cost of hospitalization was 14,604 dollars per stay and the mean length of stay was 3.7 days. In our cohort, the adverse event rate was very small. Our findings indicate racial differences in comorbidities which occurred more often in minorities. Adverse maternal outcomes of hematoma, blood transfusion, cardiac arrest, and ventricular fibrillation occurred more frequently in minority groups undergoing cesarean sections with epidural catheter placements throughout the period of 2003-2013. CONCLUSION: From using the NIS database, our findings indicate racial differences in comorbidities which occurred more often in minorities. Adverse maternal outcomes of hematoma, blood transfusion, cardiac arrest, and ventricular fibrillation occurred more frequently in minority groups undergoing cesarean sections with epidural catheter placements throughout the period of 2003-2013. Further population studies are warranted to determine the biological or perception etiologies that are contributing to these disparities.

A Step toward Healthy Newborn: An Assessment of 2 Years' Admission Pattern and Treatment Outcomes of Neonates Admitted in Special Newborn Care Units of Gujarat.

CONTEXT: Facility Based Newborn Care (FBNC) is a key strategy to improve child survival, especially in newborn care where neonatal mortality rate (NMR) is stagnant in declining. Gujarat has achieved considerable amount of reduction in child deaths, but neonatal health requires attention. The study was aimed to assess the admission pattern of Special Newborn Care Units (SNCUs) which supports decision-making. SETTINGS AND DESIGN: A cross-sectional descriptive analysis was done from secondary data of the SNCU reports on the aspects of admission patterns, morbidity, and mortality pattern. The reports had been analyzed on various critical variables. RESULTS: In 2015-2016, Gujarat has operationalized forty SNCUs by saturating each district with at least one SNCU. The study found near proportions of (53%) inborn - (47%) outborn admission and 44% admission of female. Out of 69,662 admissions, 67% were discharged, 16% died, 10% leaving against medical advice, and 7% referred to higher centers. Major reasons for admission were respiratory distress syndrome (RDS) (22%) and infection (21%). Similar pattern in mortality found as final diagnosis of deaths was RDS (23%) and infection (21%). The proportion of neonatal deaths in outborn was high compared to inborn. CONCLUSION: Strengthening of FBNC is essential to address neonatal mortality. NMR is of prime focus because the health interventions needed to tackle NMR differ from those needed for infant mortality rate and under-five mortality rate. This accentuates the need for focused attention on facility- and community-based child health interventions along with quality maternal health services and robust referral mechanisms to all delivery points.