Field based research in the era of the pandemic in resource limited settings: challenges and lessons for the future.

The coronavirus pandemic that began in December 2019, has had an unprecedented impact on the global economy, health systems and infrastructure, in addition to being responsible for significant mortality and morbidity worldwide. The "new normal" has brought along, unforeseen challenges for the scientific community, owing to obstructions in conducting field-based research in lieu of minimizing exposure through in-person contact. This has had greater ramifications for the LMICs, adding to the already existing concerns. As a response to COVID-19 related movement restrictions, public health researchers across countries had to switch to remote data collections methods. However, impediments like lack of awareness and skepticism among participants, dependence on paper-based prescriptions, dearth of digitized patient records, gaps in connectivity, reliance on smart phones, concerns with participant privacy at home and greater loss to follow-up act as hurdles to carrying out a research study virtually, especially in resource-limited settings. Promoting health literacy through science communication, ensuring digitization of health records in hospitals, and employing measures to encourage research participation among the general public are some steps to tackle barriers to remote research in the long term. COVID-19 may not be a health emergency anymore, but we are not immune to future pandemics. A more holistic approach to research by turning obstacles into opportunities will not just ensure a more comprehensive public health response in the coming time, but also bolster the existing infrastructure for a stronger healthcare system for countries.

Demand and willingness to pay for human papilloma virus vaccine for their daughters among mothers in Haryana, India: A contingent valuation study.

OBJECTIVES: Cervical cancer accounts for 10 percent of cancer deaths among women in India. The human papillomavirus (HPV) vaccine can protect against infection but it is not included in India's universal immunisation programme. This study aimed to assess the demand and willingness to pay for the HPV vaccine among mothers of adolescent daughters. METHODS: We conducted a contingent valuation exercise involving a hospital-based cross-sectional study to assess the demand for an HPV vaccine among mothers of adolescent daughters, their willingness to pay and its determinants. Participants were recruited at a tertiary care civil hospital in the city of Gurgaon in North India, and data was collected from December 2018 to February 2019. A questionnaire was administered to obtain demographic and awareness indicators. Payment cards were used to elicit the willingness to pay amount. RESULTS: Out of 319 respondents, 79% were willing to pay for the vaccine. The mean maximum willingness to pay was INR 629 (USD 35), which was less than the vaccine market price of INR 2000-3000 (USD 117-175) per dose. Participant age and number of children significantly influenced demand, while family income and awareness of cervical cancer influenced willingness to pay for the HPV vaccine. Participants were willing to spend between 3% and 34% of their monthly income on the vaccine. CONCLUSIONS: High demand and low willingness to pay for the HPV vaccine indicate low value perception of the health outcome among mothers of adolescent children in India. A strategy aimed at a price reduction of the vaccine and increasing its demand through improved awareness is important. At the same time, subsidising the vaccine in the short run is needed.

Relationship between serum lipids and depression: A cross sectional survey among adults in Haryana, India.

Introduction: Dyslipidemia and mental illnesses are significant contributors to the global noncommunicable disease burden and studies suggest an association between them. Aim: Using data from a noncommunicable disease risk factor survey conducted in Haryana, India, we undertook a secondary data analysis to examine the association between lipids and depressive symptoms. Methods: The survey involved 5,078 participants and followed the World Health Organisation STEPwise approach to NCD risk factor surveillance approach. Biochemical assessments were undertaken in a subset of participants. Lipid markers were measured using wet chemistry methods. Depressive symptoms were assessed using the Patient Health Questionnaire-9. Descriptive statistics were presented for all variables; logistic regression was used for association analyses. Results: The mean age of the study population was 38 years and 55% of them were females. A majority of the participants belonged to a rural background. The mean total cholesterol was 176 mg/dL and approximately 5% of the participants were found to have moderate to severe depression. The association of total cholesterol (odds ratio [OR] 0.99, P = 0.84), LDL-cholesterol (OR = 1.00, P = 0.19), HDL-cholesterol (OR = 0.99, P = .76), and triglycerides (OR 1.00, P = .12) with depressive symptoms was not significant. Conclusion: This study did not find any association between lipids and depressive symptoms. However, further investigations using prospective designs are warranted to understand this relationship and complex interactions with other mediating factors better.

Guidelines for dyslipidemia management in India: A review of the current scenario and gaps in research.

Cardiovascular Diseases (CVD) have a high disease burden in India. Dyslipidemia, a major CVD risk factor, requires effective management. Our review describes the appropriateness of the international dyslipidemia guidelines in the Indian context. A systematic search was performed in PubMed, Google Scholar, Cochrane Library and Science Direct to obtain relevant articles. Dyslipidemia management guidelines by western medical associations are based on their studies, with ethnic minorities underrepresented and biological features of other racial groups inadequately incorporated. The Lipid Association of India (LAI) came up with a consensus statement guided by an expert panel to adapt the western guidelines to Indians. However, absence of Indian guidelines has led to physicians basing treatment on individual preference, contributing to heterogeneity. Our review underscores the need for formulating Indian dyslipidemia management guidelines and CV risk estimation algorithms, highlighting the scope for further research. This could supplement the clinical expertise of LAI and enhance patient experience.

Factors associated with differential COVID-19 mortality rates in the SEAR nations: a narrative review.

Objectives: Since December 2019, the world has been grappling with the COVID-19 pandemic, which has caused severe loss of lives, the breakdown of health infrastructure, and disruption of the global economy. There is growing evidence on mortality patterns in high-income countries. However, similar evidence from low/middle-income nations is lacking. Our review aimed to describe COVID-19 mortality patterns in the WHO-SEAR nations, and explore the associated factors in order to explain such trends. Methods: A systematic and comprehensive search was undertaken in PubMed and Google Scholar to obtain maximum hits on COVID-19 mortality and its determinants in the SEAR, using a combination of MeSH terms and Boolean operators. The data were narratively synthesized in detail under appropriate themes. Results: Our search identified 6411 unique records. Mortality patterns were described in terms of important demographical and epidemiological indicators. Gaps in available evidence and paucity of adequate research in this area were also highlighted. Conclusions: This review examined significant contributors to COVID-19 mortality across SEAR nations, while emphasizing issues relating to insufficient studies and data quality, and reporting challenges and other concerns in resource-constrained settings. There is a compelling need for more work in this area, to help inform decision making and improve public-health response.

Deciphering the COVID-19 cytokine storm: Systematic review and meta-analysis.

INTRODUCTION: The coronavirus pandemic has affected more than 20 million people so far. Elevated cytokines and suppressed immune responses have been hypothesized to set off a cytokine storm, contributing to ARDS, multiple-organ failure and, in the most severe cases, death. We aimed to quantify the differences in the circulating levels of major inflammatory and immunological markers between severe and nonsevere COVID-19 patients. METHODS: Relevant studies were identified from PubMed, EMBASE, Web of Science, SCOPUS and preprint servers. Risk of bias was assessed for each study, using appropriate checklists. All studies were described qualitatively and a subset was included in the meta-analysis, using forest plots. RESULTS: Based on 23 studies, mean cytokine levels were significantly higher (IL-6: MD, 19.55 pg/mL; CI, 14.80, 24.30; IL-8: MD, 19.18 pg/mL; CI, 2.94, 35.43; IL-10: MD, 3.66 pg/mL; CI, 2.41, 4.92; IL-2R: MD, 521.36 U/mL; CI, 87.15, 955.57; and TNF-alpha: MD, 1.11 pg/mL; CI, 0.07, 2.15) and T-lymphocyte levels were significantly lower (CD4+ T cells: MD, -165.28 cells/µL; CI, -207.58, -122.97; CD8+ T cells: MD, -106.51 cells/µL; CI, -128.59, -84.43) among severe cases as compared to nonsevere ones. There was heterogeneity across studies due to small sample sizes and nonuniformity in outcome assessment and varied definitions of disease severity. The overall quality of studies was sub-optimal. CONCLUSION: Severe COVID-19 is characterized by significantly increased levels of pro-inflammatory cytokines and reduced T lymphocytes. Well-designed and adequately powered prospective studies are needed to amplify the current evidence and provide definitive answers to dilemmas regarding timing and type of anti-COVID-19 therapy particularly in severe patients.

Statin use and safety concerns: an overview of the past, present, and the future.

INTRODUCTION: Dyslipidemia is a significant risk factor for cardiovascular disorders and contributes to significant morbidity and mortality associated with CAD and stroke worldwide. Statins are the most commonly prescribed drugs for the prevention and management of dyslipidemia globally. Although they provide immense therapeutic benefit, they are associated with clinically significant adverse effects, predominantly muscle, nerve, liver, and cognition-related besides new-onset diabetes. This has sparked various controversies, bringing to the fore, ambiguities that continue to exist in the scientific evidence, in relation to statin-associated harms. Therefore, it becomes essential to have a better understanding of safety issues related to statin use in various populations. AREAS COVERED: This review describes the most common adverse effects of statins, examines available evidence and highlights the role of ethnicity, lipophilicity and other biological factors that could mediate and/or influence the relationship. MEDLINE was searched via PubMed to obtain relevant articles on dyslipidemia and statin safety. EXPERT OPINION: The effectiveness of statins is presently unmatched. Further research is warranted to gain insights into the diverse pharmacological effects of statins in various population subgroups. This would assist prescribers in making better informed decisions. Specific treatment strategies for vulnerable groups can significantly attenuate harms, improve risk-benefit ratios, and ultimately enhance patient experience.

Effect of workplace physical activity interventions on the cardio-metabolic health of working adults: systematic review and meta-analysis.

BACKGROUND: Adults in urban areas spend almost 77% of their waking time being inactive at workplaces, which leaves little time for physical activity. The aim of this systematic review and meta-analysis was to synthesize evidence for the effect of workplace physical activity interventions on the cardio-metabolic health markers (body weight, waist circumference, body mass index (BMI), blood pressure, lipids and blood glucose) among working adults. METHODS: All experimental studies up to March 2018, reporting cardio-metabolic worksite intervention outcomes among adult employees were identified from PUBMED, EMBASE, COCHRANE CENTRAL, CINAHL and PsycINFO. The Cochrane Risk of Bias tool was used to assess bias in studies. All studies were assessed qualitatively and meta-analysis was done where possible. Forest plots were generated for pooled estimates of each study outcome. RESULTS: A total of 33 studies met the eligibility criteria and 24 were included in the meta-analysis. Multi-component workplace interventions significantly reduced body weight (16 studies; mean diff: - 2.61 kg, 95% CI: - 3.89 to - 1.33) BMI (19 studies, mean diff: - 0.42 kg/m2, 95% CI: - 0.69 to - 0.15) and waist circumference (13 studies; mean diff: - 1.92 cm, 95% CI: - 3.25 to - 0.60). Reduction in blood pressure, lipids and blood glucose was not statistically significant. CONCLUSIONS: Workplace interventions significantly reduced body weight, BMI and waist circumference. Non-significant results for biochemical markers could be due to them being secondary outcomes in most studies. Intervention acceptability and adherence, follow-up duration and exploring non-RCT designs are factors that need attention in future research. Prospero registration number: CRD42018094436.

Satisfaction With Statin Treatment Among Adult Coronary Artery Disease Patients: An Experience From a Resource-Constrained Setting.

BACKGROUND: Statins are the most widely prescribed hypolipidaemic drugs for coronary artery disease (CAD) patients, but have been found to cause muscle and nerve related adverse effects which can affect patient satisfaction with treatment. Literature on treatment satisfaction among statin users, especially from resource-limited settings is inadequate. The aim of this cross-sectional study was to assess the level of satisfaction with treatment among statin users and evaluate the relationship between adverse effects experienced by patients and their satisfaction with the medication. METHODS: This study included 300 adult CAD patients visiting the cardiology department of a tertiary care hospital in the northern region of India, who were prescribed statins for their diagnoses. An interviewer administered, validated and standardised Treatment Satisfaction Questionnaire for Medication (version 1.4) was used for data collection. RESULTS: Around three quarters of the population reported being overall satisfied with their medication. Mean scores were calculated for Effectiveness, Convenience, Side-Effects and Global Satisfaction. The patients reported high scores (above 60%) for all domains. Those experiencing any adverse effect were found to be more likely to report lower effectiveness. Additionally, medication effectiveness showed a positive correlation with overall treatment satisfaction. CONCLUSIONS: The study shows that treatment satisfaction is critical to gauge patient experiences with the treatment which can impact medication adherence and compliance. It's a crucial measure especially among CAD and other chronic disease patients since greater satisfaction can improve clinical outcomes. More research is warranted to better understand the relationship between medication effectiveness and treatment satisfaction.

Reporting of adverse drug reactions in India: A review of the current scenario, obstacles and possible solutions.

Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug's life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians' perceptions towards reporting, problems with establishing reporting systems in hospitals and insufficient training to recognize ADRs. Measures to improve the situation include greater involvement of nurses, pharmacists as well as consumers in the reporting of ADRs, making the process simpler and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading awareness about the reporting system amongst caregivers and receivers alike. Providing a momentum to the pharmacovigilance system and ensuring a robust reporting process is a challenge but proper planning, feasible solutions and focussed efforts can help bring about the change ensuring patient safety - the ultimate goal of pharmacovigilance.

Statin related adverse effects and patient education: a study from resource limited settings.

BACKGROUND: Statins are the most widely prescribed class of drugs for coronary artery disease (CAD) patients and yet literature on the prevalence of statin related adverse effects (AEs) and gaps in patient education is quite limited especially in resource-limited settings of developing world. OBJECTIVES: The present study was conducted to determine the prevalence of myopathy (muscle ailments) and other statin associated adverse effects among CAD patients on statin therapy. The study also aimed to assess patient perceptions, attitudes and awareness concerning the use of statins. METHODS: It was a cross-sectional study conducted among 300 adult CAD patients visiting the out-patient department of a tertiary care hospital in North India, who were receiving statins for their diagnosis. An interviewer administered questionnaire was used to collect data on statin use among patients and adverse effects experienced. RESULTS: Myopathy or muscle related ailments like muscle pain, cramps and muscle weakness were the most prevalent (32, 34 and 47%, respectively), followed by numbness, tingling and burning in the extremities (31%). Joint pain and cognitive impairments were seen in nearly 20% of the patients. The level of awareness among participants regarding the use of statins was sub-optimal. Lack of knowledge and under-reporting of adverse effects were major concerns. CONCLUSION: The study shows that a considerable proportion of statin users experience adverse effects and knowledge and awareness amongst patients is inadequate. Awareness programmes and counselling for patients, sensitisation of healthcare professionals and better screening systems for monitoring AEs can help improve the scenario.