Telehealth as a Strategy for Health Equity: A Scoping Review of Telehealth in India During and Following the COVID-19 Pandemic for People with Disabilities.

Introduction: Telehealth in India is growing rapidly and represents a strategy to promote affordable, inclusive, timely and safe access to healthcare. Yet there is a risk that telehealth increases inequity due to the digital divide and existing poor health literacy. Methods: A scoping review was conducted to explore use of telehealth in India during and following the COVID-19 pandemic by people with disabilities to inform strategies to increase equity of telehealth for people with disabilities. Of 1966 studies from the initial search in four databases and three specific telehealth journals, 20 sources met the inclusion criteria, limited to a focus on physical disability in India. Results: Findings showed examples of how people with disabilities can exercise increased control in the timing of appointments, convenience of receiving services from home and not having to travel to clinics or hospitals, and platform preference through tools and applications already familiar to them. Carers and families of people with disabilities were described as highly valued stakeholders with important roles in the uptake and effectiveness of telehealth for people with disabilities. The identified benefits of telehealth resulted in high levels of user satisfaction due to increased control and convenience, however, systemic barriers for accessibility remain. Conclusion: This review suggested that if telehealth is not designed intentionally to change the status quo for people with disabilities and prioritize equity, then the benefits may not be sustainable. Recommendations for telehealth India are provided, based on both findings from the literature and analysis of results.

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.

Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis.

BACKGROUND: Coronavirus disease 2019 (COVID-19) can lead to severe hypoxic respiratory failure and death. Corticosteroids decrease mortality in severely or critically ill patients with COVID-19. However, the optimal dose remains unresolved. The ongoing randomised COVID STEROID 2 trial investigates the effects of higher vs lower doses of dexamethasone (12 vs 6 mg intravenously daily for up to 10 days) in 1,000 adult patients with COVID-19 and severe hypoxia. METHODS: This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors. DISCUSSION: This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04509973; EudraCT: 2020-003363-25.

Higher vs lower doses of dexamethasone in patients with COVID-19 and severe hypoxia (COVID STEROID 2) trial: Protocol and statistical analysis plan.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear. METHODS: The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol. DISCUSSION: The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.

Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial.

Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.

Challenges and prospects in india's digital health journey.

India's journey in the digital health arena and its contribution to the landmark resolution on digital health by the World Health Organization has been recognized globally. India has demonstrated its commitment to leverage digital health as a health system strengthening intervention, as outlined in the National Digital Health Blueprint based on which, the National Digital Health Mission (NDHM) is currently being piloted by the National health authority. Further, the Sandbox environment of NDHM is actively encouraging all the ecosystem partners to familiarize with the evolving national digital health infrastructure. The strategy to enhance the India's progress in implementation and scale-up of digital health interventions are drawing attention to workforce capacity building, harnessing health data to facilitate research and development, evidence-informed development of policies, sustaining efficiency and quality of system through appropriate monitoring, and periodic evaluation informed by frameworks specific to digital health or those adapted to evaluate health informatics applications.

An overview of mobile applications (apps) to support the coronavirus disease 2019 response in India.

BACKGROUND & OBJECTIVES: The potential benefits of mobile health (mHealth) initiatives to manage the coronavirus disease 2019 (COVID-19) pandemic have been explored. The Government of India, State governments, and healthcare organizations have developed various mobile apps for the containment of COVID-19. This study was aimed to systematically review COVID-19 related mobile apps and highlight gaps to inform the development of future mHealth initiatives. METHODS: Google Play and the Apple app stores were searched using the terms 'COVID-19', 'coronavirus', 'pandemic', and 'epidemic' in the first week of April 2020. A list of COVID-19-specific functions was compiled based on the review of the selected apps, the literature on epidemic surveillance, and national and international media reports. The World Health Organization guideline on Digital Health Interventions was used to classify the app functions under the categories of the general public, health workers, health system managers, and data services. RESULTS: The search yielded 346 potential COVID-19 apps, of which 50 met the inclusion criteria. Dissemination of untargeted COVID-19-related information on preventative strategies and monitoring the movements of quarantined individuals was the function of 27 (54%) and 19 (32%) apps, respectively. Eight (16%) apps had a contact tracing and hotspot identification function. INTERPRETATION & CONCLUSIONS: Our study highlights the current emphasis on the development of self-testing, quarantine monitoring, and contact tracing apps. India's response to COVID-19 can be strengthened by developing comprehensive mHealth solutions for frontline healthcare workers, rapid response teams and public health authorities. Among this unprecedented global health emergency, the Governments must ensure the necessary but least intrusive measures for disease surveillance.

Access to CKD Care in Rural Communities of India: a qualitative study exploring the barriers and potential facilitators.

BACKGROUND: Despite the high and rising burden of chronic kidney disease (CKD) in South Asia, factors that influence access to CKD care at the community level have not been studied previously, especially in the rural areas. We conducted a mixed methods study and interviewed key stakeholders to explore the views and experiences of key stakeholders, and identify barriers and potential facilitators that influence access to CKD care at the primary care level in rural India. METHODS: A total of 21 stakeholders participated in the study. We conducted 15 in-depth interviews on a purposive sample of stakeholders (CKD patients, healthcare providers and health planners) and one focus group discussion with 6 community health workers. The interviews were audio-recorded and transcribed verbatim. We employed the Lévesque's framework for access to care to base interview guides and structure the initial codes. By inductive and deductive approaches, thematic analysis was undertaken using QSR NVivo version 11. RESULTS: The major patient-level barriers to CKD care as reported by the most patients and healthcare providers was poor knowledge and awareness of CKD. Health system-level barriers included shortages of skilled healthcare professionals and medicines, fragmented referrals pathways to the specialists at the hospitals with inadequate follow up care. Many patients and healthcare providers, when asked about areas for improving access to CKD care, reported educational initiatives to increase awareness of CKD among healthcare providers and patients, provision of CKD related supplies, and a systems-level approach to care coordination including task shifting by engaging community health workers in CKD care, as potential facilitators. CONCLUSIONS: We identified several barriers to access CKD care at the primary care level in rural India that need urgent attention. Targeted CKD screening programs and CKD specific educational initiatives may improve awareness of CKD. Additionally, primary care infrastructure needs to be strengthened for CKD care, ensuring trained staff, availability of essential diagnostics and medications, and creating efficient referral pathways for quality CKD care.

Methodological challenges to collecting clinical and economic outcome data: Lessons from the pilot dialysis outcomes India study.

AIM: Contemporary data on clinical and economic outcomes and quality of care amongst dialysis patients in India are not available. This pilot prospective study aimed to evaluate the feasibility of data collection and follow up within routine dialysis practice to inform setting up a dialysis registry. METHODS: An electronic instrument was developed to collect information on clinical and socio-demographic characteristics, outcome and out-of-pocket expenditure on incident patients commencing haemodialysis (HD) at two centres. Dialysis unit staff were trained in collecting and entering information on an electronic case record form. Patients were followed up at 1, 3, 6, 9 and 12 months to ascertain outcomes and treatment related costs. RESULTS: A total of 119 patients (37 females, age 47.5 ± 17.2 years) were enrolled. After 1 year, 38 (32%) patients were continuing on HD; 35 (29%) had died, 30 (25%) underwent a kidney transplant, and 16 (13%) had stopped dialysis. We noted a high prevalence of catastrophic health expenditure. Data collection was facilitated by appointing a designated staff member who received an incentive. Collection of financial information, clinical course for patients transferring out of the primary unit and the cause of death, when it occurred out of hospital was challenging. CONCLUSION: Prospective data collection of incident dialysis patients was feasible but is resource-intensive. High out-of-pocket costs force some patients to stop dialysis and can generate a sense of despair. Poor patient experiences and suspicion over the use of such data adversely affects collection of important clinical and health economic data.

A randomized, controlled trial of an aerosolized vaccine against measles.

BACKGROUND: Aerosolized vaccine can be used as a needle-free method of immunization against measles, a disease that remains a major cause of illness and death. Data on the immunogenicity of aerosolized vaccine against measles in children are inconsistent. METHODS: We conducted an open-label noninferiority trial involving children 9.0 to 11.9 months of age in India who were eligible to receive a first dose of measles vaccine. Children were randomly assigned to receive a single dose of vaccine by means of either aerosol inhalation or a subcutaneous injection. The primary end points were seropositivity for antibodies against measles and adverse events 91 days after vaccination. The noninferiority margin was 5 percentage points. RESULTS: A total of 1001 children were assigned to receive aerosolized vaccine, and 1003 children were assigned to receive subcutaneous vaccine; 1956 of all the children (97.6%) were followed to day 91, but outcome data were missing for 331 children because of thawed specimens. In the per-protocol population, data on 1560 of 2004 children (77.8%) could be evaluated. At day 91, a total of 662 of 775 children (85.4%; 95% confidence interval [CI], 82.5 to 88.0) in the aerosol group, as compared with 743 of 785 children (94.6%; 95% CI, 92.7 to 96.1) in the subcutaneous group, were seropositive, a difference of -9.2 percentage points (95% CI, -12.2 to -6.3). Findings were similar in the full-analysis set (673 of 788 children in the aerosol group [85.4%] and 754 of 796 children in the subcutaneous group [94.7%] were seropositive at day 91, a difference of -9.3 percentage points [95% CI, -12.3 to -6.4]) and after multiple imputation of missing results. No serious adverse events were attributable to measles vaccination. Adverse-event profiles were similar in the two groups. CONCLUSIONS: Aerosolized vaccine against measles was immunogenic, but, at the prespecified margin, the aerosolized vaccine was inferior to the subcutaneous vaccine with respect to the rate of seropositivity. (Funded by the Bill and Melinda Gates Foundation; Measles Aerosol Vaccine Project Clinical Trials Registry-India number, CTRI/2009/091/000673.).

Indian chronic kidney disease study: Design and methods.

AIM: The rate and factors that influence progression of chronic kidney disease (CKD) in developing countries like India are unknown. A pan-country prospective, observational cohort study is needed to address these knowledge gaps. METHODS: The Indian Chronic Kidney Disease (ICKD) study will be a cohort study of approximately 5000 patients with mild to moderate CKD presenting to centres that represent different geographical regions in India. Time to 50% decline in baseline estimated glomerular filtration rate, need of renal replacement therapy or any new cardiovascular disease (CVD) event or death from CVD are the primary end points. VALUE OF STUDY: This study will provide the opportunity to determine risk factors for CKD progression and development of CVD in Indian subjects and perform international comparisons to determine ethnic and geographical differences. A bio-repository will provide a chance to discover biomarkers and explore genetic risk factors.

Dialysis outcomes in India: a pilot study.

AIM: Long-term prospective studies of health outcomes for dialysis patients are common in many parts of the world but have been rare in India. As renal replacement therapy becomes more widespread and more affordable, the measurement of patient outcomes and comparison with national and international benchmarks will be a valuable tool in planning health services and demonstrating effective use of resources. To this end, we describe a pilot study of dialysis outcomes in India which could form the basis of a comprehensive national programme of data collection. METHODS: One hundred incident patients commencing chronic haemodialysis in two north Indian nephrology centres will be followed prospectively for 12 months. Clinical outcome data will be collected comparable with that used by established dialysis registries in other countries. The economic impact of dialysis upon patients is central to the use of this treatment, so data will be collected on the direct and indirect costs of the treatment and the economic impact of dialysis on the patient and their family. VALUE OF PROJECT: This prospective cohort study of dialysis outcomes in northern India is a pilot for the collection of similar comparative data in dialysis centres in different states across the country with a view to the development of a national dialysis registry. The information on the economic impact of dialysis on patients and their families will provide one of the first detailed insights into this critical aspect of dialysis services.

CKD is the Major Cause of Death in Uddanam: A Population-Representative Study Using Smart Verbal Autopsy.

Introduction: Uddanam is an agricultural area with a high burden of chronic kidney disease of unknown etiology (CKDu). Despite reports of many deaths due to CKD in the lay press, the exact contribution of CKD to deaths remains uncertain because most deaths occur outside medical care. Methods: We used SmartVA automated verbal autopsy tool to ascertain the cause-specific mortality fractions among a 2419 subject-strong general population cohort of adult subjects in Uddanam between 2018 and 2022. Verbal autopsy interviews were conducted twice with the family members of the deceased. Results: A total of 133 deaths were recorded, giving a crude death rate of 5.5%, 10 times higher than that recorded in national surveys. CKD was responsible for 45% of all deaths, followed by ischemic heart disease (15%) and respiratory disease (6%). Conclusion: This study confirms CKD as the leading cause of mortality in this high CKD burden area and provides crucial data for public health decision-making and resource allocation.

Exploring the potential of telemedicine for improved primary healthcare in India: a comprehensive review.

Telemedicine is a promising solution to the challenges of delivering equitable and quality primary healthcare, especially in LMICs. This review evaluated peer-reviewed literature on telehealth interventions in Indian primary care published from Jan 1, 2011 to Dec 31, 2021, from PubMed, Scopus, TRIP, Google Scholar, Indian Kanoon, and Cochrane database The majority of Indian studies focus on key health issues like maternal and child health, mental health, diabetes, infectious diseases, and hypertension, mainly through patient education, monitoring, and diagnostics. Yet, there's a lack of research on telemedicine's cost-effectiveness, communication among providers, and the role of leadership in its quality and accessibility. The current research has gaps, including small sample sizes and inconsistent methodologies, which hamper the evaluation of telemedicine's effectiveness. India's varied healthcare landscape, technological limitations, and social factors further challenge telemedicine's adoption. Despite regulatory efforts, issues like the digital divide and data privacy persist. Addressing these challenges with a context-aware, technologically driven approach is crucial for enhancing healthcare through telemedicine in India.

Patterns of multimorbidity among a community-based cohort in rural India.

Background: Multimorbidity estimates are expected to increase in India primarily due to the population aging. However, there is a lack of research estimating the burden of multimorbidity in the Indian context using a validated tool. We estimated the prevalence and determinants of multimorbidity amongst the adult population of the rural Uddanam region, Andhra Pradesh. Methods: This community-based cross-sectional study was conducted as a part of an ongoing research program. Multistage cluster sampling technique was used to select 2419 adult participants from 40 clusters. Multimorbidity was assessed using Multimorbidity Assessment Questionnaire for Primary Care (MAQ-PC) tool, collecting information on 13 chronic diseases. Patient Health Questionnaire (PHQ-12) was used to screen for depression. Multiple logistic regression was conducted to identify the strongest determinants of multimorbidity. Results: Of the 2419 participants, 2289 completed the MAQ-PC tool. Mean age (standard deviation) of participants was 48.1 (13.1) years. The overall prevalence of multimorbidity was 58.5% (95% CI 56.5-60.6); with 30.7%, 15.6%, and 12.2% reporting two, three, and four chronic conditions, respectively. Acid peptic disease-musculoskeletal disease (44%) and acid peptic disease-musculoskeletal disease-hypertension (14.9%) were the most common dyad and triad. Among metabolic diseases, diabetes-hypertension (28.3%) and diabetes-hypertension-chronic kidney disease (7.6%) were the most common dyad and triad, respectively. Advancing age, female gender, and being obese were the strongest determinates of the presence of multimorbidity. Depression was highly prevalent among the study population, and participants with higher PHQ-12 score had 3.7 (2.5-5.4) greater odds of having multimorbidity. Conclusions: Our findings suggest that six of 10 adults in rural India are affected with multimorbidity. We report a higher prevalence of multimorbidity as compared with other studies conducted in India. We also identified vulnerable groups which would guide policy makers in developing holistic care packages for individuals with multimorbidity.

A scoping review on laboratory surveillance in the WHO Southeast Asia Region: Past, present and the future.

Background: The South-East Asia (SEA) region bears a significant proportion of the world's communicable disease burden. The onset of the COVID-19 pandemic has further affected the situation. A well-established laboratory-based surveillance (LBS) can reduce the burden of infectious diseases. In light of this, the review collated the existing literature on LBS system in the region and the modifications adopted by the surveillance systems during the pandemic. Methodology: We followed the guidelines for scoping review as prescribed by Arskey and O'Malley. We comprehensively searched three databases (PubMed, Scopus and CINAHL) and supplemented it with grey literature search. The screening of the articles was conducted at the title and abstract followed by full-text screening. This was followed by data extraction using a pre-tested data extraction tool by two independent reviewers. The results were presented narratively. Results: Including 75 relevant articles and documents, we compiled a list of surveillance systems. A shift from paper to dual (paper and electronic) modalities was identified across the countries. This largely low- and middle-income countries (LMIC) area face challenges in reporting, resources, and collaboration-related issues. While some countries have well-established National Reference Laboratories; others have more private than public-owned laboratories. Given the COVID-19 pandemic, modifications to the existing laboratory capacities to enable real-time surveillance was identified. Laboratory capacity complemented with genomic surveillance can indubitably aid in disease detection and control. Limitations due to inaccessible government portals, and language barriers are acknowledged. This review identified a comprehensive list of surveillance systems in the region, challenges faced in using these surveillance systems and inform the decision makers about the benefits of integrating fragmented surveillance systems. Conclusion: Regionally and nationally integrated genomic and laboratory surveillance systems justify capital investments, as their payoffs rationalise such costs owing to economies of scale over time. Further, as data flows are harmonized and standardized, algorithm- and computing-based pattern recognition methods allow for targeted and accurate disease prediction when integrated with, potentially, climate and weather systems data. Trained human resources are a sine qua non to optimize such investments, but in the medium to long run, such investments will buttress initiatives in other arenas at the regional level.

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.

Measuring the Burden of Infodemics: Summary of the Methods and Results of the Fifth WHO Infodemic Management Conference.

Background: An infodemic is excess information, including false or misleading information, that spreads in digital and physical environments during a public health emergency. The COVID-19 pandemic has been accompanied by an unprecedented global infodemic that has led to confusion about the benefits of medical and public health interventions, with substantial impact on risk-taking and health-seeking behaviors, eroding trust in health authorities and compromising the effectiveness of public health responses and policies. Standardized measures are needed to quantify the harmful impacts of the infodemic in a systematic and methodologically robust manner, as well as harmonizing highly divergent approaches currently explored for this purpose. This can serve as a foundation for a systematic, evidence-based approach to monitoring, identifying, and mitigating future infodemic harms in emergency preparedness and prevention. Objective: In this paper, we summarize the Fifth World Health Organization (WHO) Infodemic Management Conference structure, proceedings, outcomes, and proposed actions seeking to identify the interdisciplinary approaches and frameworks needed to enable the measurement of the burden of infodemics. Methods: An iterative human-centered design (HCD) approach and concept mapping were used to facilitate focused discussions and allow for the generation of actionable outcomes and recommendations. The discussions included 86 participants representing diverse scientific disciplines and health authorities from 28 countries across all WHO regions, along with observers from civil society and global public health-implementing partners. A thematic map capturing the concepts matching the key contributing factors to the public health burden of infodemics was used throughout the conference to frame and contextualize discussions. Five key areas for immediate action were identified. Results: The 5 key areas for the development of metrics to assess the burden of infodemics and associated interventions included (1) developing standardized definitions and ensuring the adoption thereof; (2) improving the map of concepts influencing the burden of infodemics; (3) conducting a review of evidence, tools, and data sources; (4) setting up a technical working group; and (5) addressing immediate priorities for postpandemic recovery and resilience building. The summary report consolidated group input toward a common vocabulary with standardized terms, concepts, study designs, measures, and tools to estimate the burden of infodemics and the effectiveness of infodemic management interventions. Conclusions: Standardizing measurement is the basis for documenting the burden of infodemics on health systems and population health during emergencies. Investment is needed into the development of practical, affordable, evidence-based, and systematic methods that are legally and ethically balanced for monitoring infodemics; generating diagnostics, infodemic insights, and recommendations; and developing interventions, action-oriented guidance, policies, support options, mechanisms, and tools for infodemic managers and emergency program managers.