Validation of Blood Pressure Devices as per 2020 World Health Organization Technical Specifications: A Scoping Review of Global Literature.

BACKGROUND: To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs. METHODS: A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website. RESULTS: We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings. CONCLUSIONS: Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation.

Challenges in delivering primary care via telemedicine during COVID-19 pandemic in India: A review synthesis using systems approach.

Background: Countries, including India, were quick to adopt telemedicine for delivering primary care in response to the widespread disruptions due to the coronavirus disease 2019 (COVID-19) pandemic. This expeditious adoption was critical and the challenges faced during this exigency could guide the design and delivery of future telemedicine applications toward strengthening primary healthcare services. Methods: To identify the challenges in delivering primary care via telemedicine technology in the Indian context, a scoping review was conducted. Drawing from the systems approach in healthcare delivery, the review findings are summarized at four levels, patient, provider, healthcare organizations, and policy. Results: The initial search yielded 247 articles and 13 met our inclusion criteria. This review highlighted that telemedicine facilitated the continuity of care during COVID-19 but not without challenges. Low levels of education and computer literacy along with the language barriers posed the predominant challenges at the patient level. Providers had concerns related to digital literacy, clinical process flows, legal liabilities, and unethical behavior of the patients. The policy-level challenges include data privacy and security, reimbursement models, unethical behavior by the patient, or provider, and regulating prescriptions of psychotropic drugs. A lack of an integrated telehealthcare model covering diagnostics, prescriptions, and medication supply mirrored the existing fragmentation of care delivery. Conclusion: Telemedicine has the potential to improve primary healthcare delivery even beyond COVID-19. Currently, telemedicine applications in India are only facilitating a remote consultation wherein an integrated person-centered care is lacking. There is a need to acknowledge and factor in the inter-connectedness of health system elements for ensuring an effective and efficient healthcare delivery via telemedicine.

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review.

BACKGROUND: Although well recognized for its scientific value, data sharing from clinical trials remains limited. Steps toward harmonization and standardization are increasing in various pockets of the global scientific community. This issue has gained salience during the COVID-19 pandemic. Even for agencies willing to share data, data exclusivity practices complicate matters; strict regulations by funders affect this even further. Finally, many low- and middle-income countries (LMICs) have weaker institutional mechanisms. This complex of factors hampers research and rapid response during public health emergencies. This drew our attention to the need for a review of the regulatory landscape governing clinical trial data sharing. OBJECTIVE: This review seeks to identify regulatory frameworks and policies that govern clinical trial data sharing and explore key elements of data-sharing mechanisms as outlined in existing regulatory documents. Following from, and based on, this empirical analysis of gaps in existing policy frameworks, we aimed to suggest focal areas for policy interventions on a systematic basis to facilitate clinical trial data sharing. METHODS: We followed the JBI scoping review approach. Our review covered electronic databases and relevant gray literature through a targeted web search. We included records (all publication types, except for conference abstracts) available in English that describe clinical trial data-sharing policies, guidelines, or standard operating procedures. Data extraction was performed independently by 2 authors, and findings were summarized using a narrative synthesis approach. RESULTS: We identified 4 articles and 13 policy documents; none originated from LMICs. Most (11/17, 65%) of the clinical trial agencies mandated a data-sharing agreement; 47% (8/17) of these policies required informed consent by trial participants; and 71% (12/17) outlined requirements for a data-sharing proposal review committee. Data-sharing policies have, a priori, milestone-based timelines when clinical trial data can be shared. We classify clinical trial agencies as following either controlled- or open-access data-sharing models. Incentives to promote data sharing and distinctions between mandated requirements and supportive requirements for informed consent during the data-sharing process remain gray areas, needing explication. To augment participant privacy and confidentiality, a neutral institutional mechanism to oversee dissemination of information from the appropriate data sets and more policy interventions led by LMICs to facilitate data sharing are strongly recommended. CONCLUSIONS: Our review outlines the immediate need for developing a pragmatic data-sharing mechanism that aims to improve research and innovations as well as facilitate cross-border collaborations. Although a one-policy-fits-all approach would not account for regional and subnational legislation, we suggest that a focus on key elements of data-sharing mechanisms can be used to inform the development of flexible yet comprehensive data-sharing policies so that institutional mechanisms rather than disparate efforts guide data generation, which is the foundation of all scientific endeavor.

Glycemic control monitoring in patients with tuberculosis and diabetes: a descriptive study from programmatic setting in Tamil Nadu, India.

Background: India's national tuberculosis (TB) programme recommends that among patients with diabetes mellitus and TB, fasting blood glucose (FBG) be recorded at baseline, the end of intensive phase and the end of continuation phase of TB treatment. We conducted this operational research in select districts of Tamil Nadu, India, in 2016 to determine the availability of blood glucose records and glycemic control status during TB treatment. Methods: This was a descriptive study involving secondary programme data. Glycemic control during TB treatment was 'optimal' if both baseline and end of intensive phase FBG (during TB treatment) were <130 mg/dl. In the absence of FBG, we used random blood glucose (RBG), with <180 mg/dl as the cut off. Results: Of 438 patients, FBG at baseline, the end of intensive phase and the end of continuation phase were each available in <20%. Glycemic control status was known for 94% (412/438) patients at baseline and for 91% (400/438) during TB treatment. Among those with known glycemic status, glycemic control was not optimal in 77% of patients (316/412) at baseline and in 84% (337/400) during TB treatment. The proportion of patients with unfavourable TB treatment outcomes at the end of intensive phase was 11% (46/438) and at the end of continuation phase was 5% (21/438). We decided against assessing factors associated with glycemic control during TB treatment and association between glycemic control and TB treatment outcomes because glycemic control assessment, if any, was based mostly on RBG values. Conclusion: Among patients with diabetes and tuberculosis, recording of FBG during tuberculosis treatment requires urgent attention.

"Who has to do it at the end of the day? Programme officials or hospital authorities?" Airborne infection control at drug resistant tuberculosis (DR-TB) centres of Karnataka, India: a mixed-methods study.

BACKGROUND: Drug resistant tuberculosis (DR-TB) centers admit patients with DR-TB for initiation of treatment and thereby concentrate the patients under one setting. It becomes imperative to assess the compliance of DR-TB centres to national airborne infection control (AIC) guidelines and explore the provider perspectives into reasons for unsatisfactory compliance. METHODS: This mixed methods study (triangulation design) was carried out across all the six DR-TB centers of Karnataka state, India, between November 2016 and April 2017. Non-participant observation using a structured format was carried out at the DR-TB wards (n = 6), outpatient departments (n = 6), patient waiting areas outside outpatient departments (n = 6) and culture and drug susceptibility testing laboratories (n = 3). Structured interviews of admitted patients (n = 30) were done to assess the knowledge on cough hygiene and sputum disposal. Key informant interviews (KIIs) of health care providers (n = 20) were done. Manual descriptive content analysis was done to analyse the transcripts of KIIs. RESULTS: The findings related to compliance in non-participant observation were corroborated by KIIs. All the laboratories were consistently implementing the AIC guidelines. Compliance to hand hygiene, wet mopping and ventilation measures were satisfactory in four or more DR-TB wards. The non-availability of N95 masks in wards as well as outpatient departments was staggering. Sputum disposal without prior disinfection and the lack of display materials on cough hygiene and patient education was common. Patient fast tracking in outpatient department waiting areas and visitor restrictions in wards were lacking. Trainings on AIC measures were uncommon. About half and one-third of patients admitted had satisfactory knowledge regarding sputum disposal and situations demanding mask respectively. The reasons for unsatisfactory compliance to AIC guidelines were poor coordination between programme and hospital authorities leading to lack of ownership; ineffective or non-existent infection control committees; vacant posts of medical officers; and attitudes of health care delivery staff. CONCLUSION: Compliance with AIC guidelines in DR-TB centers of Karnataka was sub-optimal. The reasons identified require urgent attention of the programme managers and hospital authorities.

Enhancing the role of private practitioners in tuberculosis prevention and care activities in India.

India accounts for the highest number of incident tuberculosis (TB) cases globally. Hence, to impact the TB incidence world over, there is an urgent need to address and accelerate TB control activities in the country. Nearly, half of the TB patients first seek TB care in private sector. However, the participation of private practitioners (PPs) has been patchy in TB prevention and care and distrust exists between public and private sector. PPs usually have varied diagnostic and treatment practices that are inadequate and amplify the risk of drug resistance. Hence, their regulation and involvement as key stakeholders are important in TB prevention and care in India if we are to achieve TB control at global level. However, there remain certain barriers and gaps, which are preventing their upscaling. The current paper aims to discuss the status of private sector involvement in TB prevention and care in India. The paper also discusses the strategies and initiatives taken by the government in this regard as evidence shows that the involvement of private sector in co-opting directly observed treatment short-course (DOTS) helps to enhance case finding and treatment outcomes; it improves the accessibility of quality TB care with greater geographic coverage. Besides public-private mix, DOTS has been found more cost-effective and reduces financial burden of patients. The paper also offers to present some more solutions both at policy and program level for upscaling the engagement of PPs in the national TB control program.

TB Treatment Delays in Odisha, India: Is It Expected Even after These Many Years of RNTCP Implementation?

BACKGROUND: In India, the Revised National TB Control Programme (RNTCP) envisages initiation of TB treatment within seven days of diagnosis among smear-positive patients. After nearly two decades of RNTCP implementation, treatment delays are usually not expected. OBJECTIVES: To determine the proportion of sputum smear-positive TB patients who were initiated on treatment after seven days and their associated risk factors. METHODS: The study was conducted in Cuttack and Rayagada districts of Odisha. It was a retrospective cohort study that involves review of TB treatment registers and laboratory registers for 2013. RESULTS: Among 1,800 pulmonary TB (PTB) patients, 1,074 (60%) had been initiated on treatment within seven days of diagnosis, 721 (40%) had been initiated on treatment more than seven days, and 354 (20%) had delays of more than 15 days. The mean duration between TB diagnosis and treatment initiation was 21 days with a range of 8-207 days (median = 14 days). Odds of treatment delay of more than seven days were 4.9 times (95% confidence interval [CI] 3.3-6.6) among those who had been previously treated, 6.2 times (95% CI 1.3-29.7) among those infected with HIV, and 1.8 times (95% CI 1.1-2.9) among those diagnosed outside district DMC. CONCLUSION: Delay in initiation of TB treatment occurred in majority of the smear-positive patients. The RNTCP should focus on core areas of providing quality TB services with time-tested strategies. To have real-time monitoring mechanisms for diagnosed smear-positive TB patients is expected to be the way forward.

Sleeping with the enemy: the United Nations Development Programme and its position on the non-communicable disease epidemic.

The United Nations Development Programme's (UNDP) position on non-communicable diseases (NCDs) is undermined by a key issue at the global institutional level. Fundamentally, the nature of the relationship between international development agencies and the tobacco industry is at odds with the professed public health priorities of the former. At its core, the business model of the tobacco industry is premised on the sale of addictive and disease-causing substances that fuel NCDs in the first place. The role of the United Nations system and, in particular, UNDP is to 'build nations that can withstand crisis', not to collaborate with entities that profit from crises. This simple and well-established fact cannot be overlooked. We outline an array of conflict of interests. If the effects of NCDs are ever to be reversed, then international agencies such as the UNDP ought to adhere to ethical standards in choosing partners and avoid conflict of interests. In the absence of this, the UNDP may well compromise its own agenda and proliferate NCDs rather than containing them.