Dataset Information

Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies.

ABSTRACT:

Objectives

To document and share the process of establishing the nationally representative multisite surveillance network for intussusception in India, coordination, data management and lessons learnt from the implementation.

Design

This study combined both retrospective and prospective surveillance approaches.

Setting

19 tertiary care institutions were selected in India considering the geographic representation and public and private mix PARTICIPANTS: All children under-2 years of age with intussusception PRIMARY AND SECONDARY OUTCOME MEASURES: The experience of site selection, regulatory approvals, data collection, quality assurance and network coordination were documented.

Results

The site selection process involved systematic and objective four steps including shortlisting of potential institutions, information seeking and telephonic interaction, site visits and site selection using objective criteria. Out of over 400 hospitals screened across India, 40 potential institutions were shortlisted and information was sought by questionnaire and interaction with investigators. Out of these, 25 institutes were visited and 19 sites were finally selected to participate in the study. The multistep selection process allowed filtering and identification of sites with adequate capacity and motivated investigators. The retrospective surveillance documented 1588 cases (range: 14-652 cases/site) and prospective surveillance recruited 621 cases (range: 5-191 cases/site). The multilayer quality assurance measures monitored and ensured protocol adherence, complete record retrieval and data completeness. The key challenges experienced included time taken for obtaining regulatory and ethical approvals, which delayed completion of the study. Ten sites continued with another multisite vaccine safety surveillance study.

Conclusion

The experience and results of this systematic and objective site selection method in India are promising. The systematic multistep site selection and data quality assurance methods presented here are feasible and practical. The lessons from the establishment and coordination of this surveillance network can be useful in planning, selecting the sites and conducting multisite and surveillance studies in India and developing countries.

SUBMITTER: Das MK

PROVIDER: S-EPMC8166592 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesThe study aimed to document the association between intussusception in Indian children and meteorological parameters and examine regional variations.DesignA bidirectional (retrospective and prospective) surveillance between July 2010 and September 2017.SettingAt 20 hospitals in India, retrospective case record review during July 2010 and March 2016 and prospective surveillance during April 2016 and September 2017 were performed.Participants2161 children aged 2-24 months with first intussusception episode were included.InterventionsThe monthly mean meteorological parameters (temperature, sunshine, rainfall, humidity and wind speed) for the study sites were collected.MethodsThe association between monthly intussusception cases and meteorological parameters was examined at pooled, regional and site levels using Pearson (r) and Spearman's rank-order (ρ) correlation, factorial analysis of variance, and Poisson regression or negative binomial regression analyses.ResultsThe intussusception cases were highest in summer and lowest in autumn seasons. Pearson correlation analysis showed that temperature (r=0.056; p<0.05), wind speed (r=0.134; p<0.01) and humidity (r=0.075; p<0.01) were associated with monthly intussusception cases. Spearman's rank-order correlation analysis found that temperature (ρ=0.049; p<0.05), wind speed (ρ=0.096; p<0.01) and sunshine (ρ=0.051; p<0.05) were associated with monthly intussusception cases. Poisson regression analysis resulted that monthly intussusception case was associated with rising temperature (North region, p<0.01 and East region, p<0.05), sunshine (North region, p<0.01), humidity (East region, p<0.01) and wind speed (East region, p<0.01). Factorial analysis of variance revealed a significant seasonal difference in intussusception cases for pooled level (p<0.05), 2-6 months age group (p<0.05) and North region (p<0.01). Significant differences in intussusception cases between summer and autumn seasons were observed for pooled (p<0.01), children aged 2-6 months (p<0.05) and 7-12 months (p<0.05).ConclusionsSignificant correlations between intussusception cases and temperature, humidity, and wind speed were observed at pooled and regional level in India. A peak in summer months was noted, which may be used for prediction, early detection and referral for appropriate management of intussusception.

Project description:BACKGROUND:Inadequate administrative health data, suboptimal public health infrastructure, rapid and unplanned urbanization, environmental degradation, and poor penetration of information technology make the tracking of health and well-being of populations and their social determinants in the developing countries challenging. Technology-integrated comprehensive surveillance platforms have the potential to overcome these gaps. OBJECTIVE:This paper provides methodological insights into establishing a geographic information system (GIS)-integrated, comprehensive surveillance platform in rural North India, a resource-constrained setting. METHODS:The International Clinical Epidemiology Network Trust International established a comprehensive SOMAARTH Demographic, Development, and Environmental Surveillance Site (DDESS) in rural Palwal, a district in Haryana, North India. The surveillance platform evolved by adopting four major steps: (1) site preparation, (2) data construction, (3) data quality assurance, and (4) data update and maintenance system. Arc GIS 10.3 and QGIS 2.14 software were employed for geospatial data construction. Surveillance data architecture was built upon the geospatial land parcel datasets. Dedicated software (SOMAARTH-1) was developed for handling high volume of longitudinal datasets. The built infrastructure data pertaining to land use, water bodies, roads, railways, community trails, landmarks, water, sanitation and food environment, weather and air quality, and demographic characteristics were constructed in a relational manner. RESULTS:The comprehensive surveillance platform encompassed a population of 0.2 million individuals residing in 51 villages over a land mass of 251.7 sq km having 32,662 households and 19,260 nonresidential features (cattle shed, shops, health, education, banking, religious institutions, etc). All land parcels were assigned georeferenced location identification numbers to enable space and time monitoring. Subdivision of villages into sectors helped identify socially homogenous community clusters (418/676, 61.8%, sectors). Water and hygiene parameters of the whole area were mapped on the GIS platform and quantified. Risk of physical exposure to harmful environment (poor water and sanitation indicators) was significantly associated with the caste of individual household (P=.001), and the path was mediated through the socioeconomic status and density of waste spots (liquid and solid) of the sector in which these households were located. Ground-truthing for ascertaining the land parcel level accuracies, community involvement in mapping exercise, and identification of small habitations not recorded in the administrative data were key learnings. CONCLUSIONS:The SOMAARTH DDESS experience allowed us to document and explore dynamic relationships, associations, and pathways across multiple levels of the system (ie, individual, household, neighborhood, and village) through a geospatial interface. This could be used for characterization and monitoring of a wide range of proximal and distal determinants of health.

Project description:BACKGROUND:A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS:We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS:From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS:The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

Project description:OBJECTIVE Dysfunction of distributed neural networks underlies many brain disorders. The development of neuromodulation therapies depends on a better understanding of these networks. Invasive human brain recordings have a favorable temporal and spatial resolution for the analysis of network phenomena but have generally been limited to acute intraoperative recording or short-term recording through temporarily externalized leads. Here, the authors describe their initial experience with an investigational, first-generation, totally implantable, bidirectional neural interface that allows both continuous therapeutic stimulation and recording of field potentials at multiple sites in a neural network. METHODS Under a physician-sponsored US Food and Drug Administration investigational device exemption, 5 patients with Parkinson's disease were implanted with the Activa PC+S system (Medtronic Inc.). The device was attached to a quadripolar lead placed in the subdural space over motor cortex, for electrocorticography potential recordings, and to a quadripolar lead in the subthalamic nucleus (STN), for both therapeutic stimulation and recording of local field potentials. Recordings from the brain of each patient were performed at multiple time points over a 1-year period. RESULTS There were no serious surgical complications or interruptions in deep brain stimulation therapy. Signals in both the cortex and the STN were relatively stable over time, despite a gradual increase in electrode impedance. Canonical movement-related changes in specific frequency bands in the motor cortex were identified in most but not all recordings. CONCLUSIONS The acquisition of chronic multisite field potentials in humans is feasible. The device performance characteristics described here may inform the design of the next generation of totally implantable neural interfaces. This research tool provides a platform for translating discoveries in brain network dynamics to improved neurostimulation paradigms. Clinical trial registration no.: NCT01934296 (clinicaltrials.gov).

Project description:BACKGROUND:Intussusception is a gastrointestinal condition in which early treatment is critical. Although its epidemiology and comorbidities have been studied, few studies have included the entire pediatric population of a country. Therefore, we aimed to analyze the epidemiologic features of pediatric intussusception patients and identify comorbidities associated with intussusception in South Korea, using the public health database. METHODS:We analyzed the data of children below 18?years of age, from the national database of South Korea, who were diagnosed with intussusception and managed such as air reduction or surgical methods from 2008 to 2016. Patients were categorized into six groups based on the comorbid diseases. Patients with structural lesion in gastrointestinal tract were divided diagnosis or diagnosis code. RESULTS:The number of patients diagnosed with intussusception were 25,023 (16,024 males, 64.0%). Of them, the highest percentage was patients aged between 2 and 36?months (20,703; 82.7%). The incidence per 100,000 individuals aged up to 2?years was 196.7. The number of males were 16,024 (64.0%) and were almost twice the number of 8999 (36.0%) female patients. The maximum number of cases (n =?2517; 10.1%) were seen in September, followed by July (n =?2469; 9.9%). In February, the number of cases was lowest at 1448 (5.8%) patients (P <?0.001). The number of patients with structural lesions of the gastrointestinal tract that could lead to intussusception was 1207 (4.8%), while patients with acute gastrointestinal infectious disease were 4541 (18.1%). Among the structural lesions of the gastrointestinal tract that could be the leading cause of intussusception, lymphadenopathy was the most common, seen in 462 (56.6%) patients and an appendix-related condition was seen in 260 (31.9%) patients. Infectious diseases were more common in the younger children, while systemic diseases were more common in the older. CONCLUSION:We confirmed that pediatric intussusception in South Korea shows a seasonal tendency, which is age-dependent and is associated with an exposure to infectious agents. Some infectious pathogens and underlying diseases might play an important role in the pathophysiology of intussusception.

Project description:BackgroundMass gathering (MG) events are associated with public health risks. During the period January 14 to March 4, 2019, Kumbh Mela in Prayagraj, India was attended by an estimated 120 million visitors. An onsite disease surveillance was established to identify and respond to disease outbreaks.MethodsA health coordination committee was established for planning. Disease surveillance was prioritized and risk assessment was done to identify diseases/conditions based on epidemic potential, severity of illness, and reporting requirement under the International Health Regulations (IHR) of 2005. A daily indicator and event-based disease surveillance was planned. The indicator-based surveillance (IBS) manually and electronically recorded data from patient hospital visits and collected MG area water testing data to assess trends. The event-based surveillance (EBS) helped identify outbreak signals based on pre-identified event triggers from the media, private health facilities, and the food safety department. Epidemic intelligence was used to analyse the data and events to detect signals, verify alerts, and initiate the response.ResultsAt Kumbh Mela, disease surveillance was established for 22 acute diseases/syndromes. Sixty-five health facilities reported 156 154 illnesses (21% of a total 738 526 hospital encounters). Among the reported illnesses, 95% (n = 148 834) were communicable diseases such as acute respiratory illness (n = 52 504, 5%), acute fever (n = 41 957, 28%), and skin infections (n = 27 094, 18%). The remaining 5% (n = 7300) were non-communicable diseases (injuries n = 6601, 90%; hypothermia n = 224, 3%; burns n = 210, 3%). Water samples tested inadequate for residual chlorine in 20% of samples (102/521). The incident command centre generated 12 early warning signals from IBS and EBS: acute diarrheal disease (n = 8, 66%), vector-borne disease (n = 2, 16%), vaccine-preventable disease (n = 1, 8%), and thermal event (n = 1, 8%). There were two outbreaks (acute gastroenteritis and chickenpox) that were investigated and controlled.ConclusionsThis onsite disease surveillance imparted a public health legacy by successfully implementing an epidemic intelligence enabled system for early disease detection and response to monitor public health risks. Acute respiratory illnesses emerged as a leading cause of morbidity among visitors. Future MG events should include disease surveillance as part of planning and augment capacity for acute respiratory illness diagnosis and management.