STEPS – a patient centric and low-cost solution to ensure standards of TB care to patients reaching private sector in India

Background More than half of the TB patients in India seek care from the private sector. Two decades of attempts by the National TB Program to improve collaboration between the public and private sectors have not worked except in a few innovative pilots. The System for TB Elimination in Private Sector (STEPS) evolved in 2019 as a solution to ensure standards of TB care to every patient reaching the private sector. We formally evaluated the STEPS to judge the success of the model in achieving its outcomes and to inform decisions about scaling up of the model to other parts of the country. Methods An evaluation team was constituted involving all relevant stakeholders. A logic framework for the STEPS model was developed. The evaluation focused on (i) processes - whether the activities are taking place as intended and (ii) proximal outcomes - improvements in quality of care and strengthening of TB surveillance system. We (i) visited 30 randomly selected STEPS centres for assessing infrastructure and process using a checklist, (ii) validated the patient data with management information system of National TB Elimination Program (NTEP) by telephonic interview of 57 TB patients (iii) analysed the quality of patient care indicators over 3 years from the management information system (iv) conducted in-depth interviews (IDI) with 33 beneficiaries and stakeholders to understand their satisfaction and perceived benefits of STEPS and (v) performed cost analysis for the intervention from the perspective of NTEP, private hospital and patients. Results Evaluation revealed that STEPS is an acceptable model to all stakeholders. IDIs revealed that all patients were satisfied about the services received. Data in management information system of NTEP were consistent with the hospital records and with the information provided by the patient. Quality of TB care indicators for patients diagnosed in private hospitals showed improvements over years as proportion of TB patients notified from private sector with a microbiological confirmation of diagnosis improved from 25% in 2018 to 38% in 2020 and the documented treatment success rate increased from 33% (2018 cohort) to 88% (2019 cohort). Total additional programmatic cost (deducting cost for patient entitlements) per additional patient with successful treatment outcome was estimated to be 67 USD. Total additional expense/business loss for implementing STEPS for the hospital diagnosing 100 TB patients in a year was estimated to be 573 USD while additional minimum returns for the hospital was estimated to be 1145 USD. Conclusion Evaluation confirmed that STEPS is a low cost and patient-centric strategy. STEPS successfully addressed the gaps in the quality of care for patients seeking care in the private sector and ensured that services are aligned with the standards of TB care. STEPS could be scaled up to similar settings.

Development of an Efficient Monitoring System Using Fog Computing and Machine Learning Algorithms on Healthcare 4.0

Disruptive innovations in data management and analytics have led to the development of patient-centric Healthcare 4.0 from the hospital-centric Healthcare 3.0. This work presents an IoT-based monitoring systems for patients with cardiovascular abnormalities. IoT-enabled wearable ECG sensor module transmits the readings in real-time to the fog nodes/mobile app for continuous analysis. Deep learning/machine learning model automatically detect and makes prediction on the rhythmic anomalies in the data. The application alerts and notifies the physician and the patient of the rhythmic variations. Real-time detection aids in the early diagnosis of the impending heart condition in the patient and helps physicians clinically to make quick therapeutic decisions. The system is evaluated on the MIT-BIH arrhythmia dataset of ECG data and achieves an overall accuracy of 95.12% in classifying cardiac arrhythmia.

A Perspective on Patient Centricity in Health Ecosystem: A Call for an Enabling Culture

Today, patients are more empowered and informative than ever because of which the aim of the health ecosystem is to centre on the patient centred goals. The term patient centricity is no longer a health care buzzword; however, a lot needs to be done to implement this concept in the real world. Therefore, the objective of the current research is to bring in the importance of cultural change in the health ecosystem for the smooth flow of patient centricity. The current research is exploratory in nature that tried to explore the concept of patient centricity in the health ecosystem through literature and interviews. The research utilized secondary sources such as Journal articles, reports, and such others to draw how OCTAPACE culture is important in health ecosystem for promoting patient centricity. The eight strong pillars of OCTAPACE are Openness, Confrontation, Trust, Autonomy, Proactivity, Authenticity, Collaboration, and Experimentation and its relationship with patient centricity is proposed. The researchers can reasonably deduce that patient centricity requires a changed mindset and vision shared by all the stakeholders. For this, support from regulators, pharmaceutical companies, health care professionals etc. are required. The current research is among a few researches that highlights the importance of OCTAPACE culture in health ecosystem. This construct to meet patient centric goals is worthy of additional study. From the practical standpoint, training can be provided to all the employees of the entire health ecosystem to incorporate the OCTAPACE culture and to meet the demands of the patients and caregivers.

Discoveries and Innovations in Drug Development (Vol. 26, No. 1, Full Issue)

For the month of January 2022, APBN looks at some discoveries and innovation in pharmacology. In Features, Dr Harish Dave, Co-Founder and Chief Medical Officer of AUM Biosciences, discusses today's shifting paradigm in oncology drug development towards highly selective, minimally toxic, and patient-centric treatments, while Jade Pallett, Chief Technology Officer for Zoono UK & Europe, sheds light on how antimicrobial coatings outdo traditional methods of disinfection. Then, we have A/Prof Alexandra Sharland, Dr Nicole Mifsud, and Eric Son to elucidate how understanding antigen-specificity of host T cells can reduce organ transplantation rejection. Finally, in Spotlights, we have two interviews – one where we speak to Mr Willson Deng, CEO of Arcstone, on the role of digital technology in supporting MedTech manufacturing, and the other with Liu Qun, Head of IQVIA, China, where we learn more about the Chinese biopharmaceutical market.

Using Metabolite Data to Develop Patient Centric Specification for Amide Impurity in Vildagliptin Tablets

Many specified impurities in vildagliptin's finished product have been disclosed in the literature that are above their qualification threshold. We used the impurity B (amide impurity) as a case example to explore whether existing literature can be leveraged to determine the safe level of impurity and thereby develop a patient-centric specification (PCS) for impurities. No-observed-adverse-effect level (NOAEL) was derived from rate metabolism information and converted to human equivalent dose (HED). The HED was estimated as 6.5 mg/day. The high qualification levels are supported by repeat dose toxicity studies performed in rats, mice and dogs. Maximum theoretical amount (MTA) was correlated with the maximum observed amount (MOA) to verify whether the exposure was due to impurity and/or metabolite. MOA/MTA was found ≥1 suggesting that metabolism contributed to the amount excreted in feces and therefore could be used to further justify a higher specification limit than the usual one of ≤0.5%. Quite often the drug metabolism and degradation pathways overlap, resulting in the formation of identical constituents. Therefore, metabolism data can be leveraged for deriving safe levels of degradation impurities and develop PCS for impurities.

Overcoming Barriers to Injectable Therapies: Development of the ORBIT Intervention Within a Behavioural Change Framework

It is estimated among individuals with type 2 diabetes (T2D) requiring injectable therapies to achieve optimal glycaemic control, one-third are reluctant to initiate therapies, with approximately 80% choosing to discontinue or interrupt injectable regimens soon after commencement. Initiation of injectables is a complex issue, with effectiveness of such treatments undermined by non-adherence or poor engagement. Poor engagement and adherence are attributed to psychological aspects such as individuals’ negative perceptions of injectables, depression, anxiety, feelings of shame, distress and perceived lack of control over their condition. The aim of this study was to describe the development of a structured diabetes intervention to address psychological barriers to injectable treatments among a cohort of those with T2D; conducted within a behavioural change framework. An evidence base was developed to inform on key psychological barriers to injectable therapies. A systematic review highlighted the need for theory-based, structured diabetes education focussed on associated psychological constructs to inform effective, patient-centric provisions to improve injectable initiation and persistence. Findings from the focus groups with individuals who had recently commenced injectable therapies, identified patient-centric barriers to initiation and persistence with injectables. Findings from the systematic review and focus groups were translated via Behavioural Change Wheel (BCW) framework to develop an intervention for people with T2D transitioning to injectable therapies: Overcoming and Removing Barriers to Injectable Treatment in T2D (ORBIT). This article describes how psychological barriers informed the intervention with these mapped onto relevant components, intervention functions and selected behaviour change techniques, and finally aligned with behaviour change techniques. This article outlines the systematic approach to intervention development within the BCW framework; guiding readers through the practical application of each stage. The use of the BCW framework has ensured the development of the intervention is theory driven, with the research able to be evaluated and validated through replication due to the clarity around processes and tasks completed at each stage.

Hyperledger Healthchain: Patient-Centric IPFS-Based Storage of Health Records

Blockchain-based electronic health system growth is hindered by privacy, confidentiality, and security. By protecting against them, this research aims to develop cybersecurity measurement approaches to ensure the security and privacy of patient information using blockchain technology in healthcare. Blockchains need huge resources to store big data. This paper presents an innovative solution, namely patient-centric healthcare data management (PCHDM). It comprises the following: (i) in an on-chain health record database, hashes of health records are stored as health record chains in Hyperledger fabric, and (ii) off-chain solutions that encrypt actual health data and store it securely over the interplanetary file system (IPFS) which is the decentralized cloud storage system that ensures scalability, confidentiality, and resolves the problem of blockchain data storage. A security smart contract hosted through container technology with Byzantine Fault Tolerance consensus ensures patient privacy by verifying patient preferences before sharing health records. The Distributed Ledger technology performance is tested under hyper ledger caliper benchmarks in terms of transaction latency, resource utilization, and transaction per second. The model provides stakeholders with increased confidence in collaborating and sharing their health records.