The Generalized Data Model for clinical research

Danese, Mark D.; Halperin, Marc; Duryea, Jennifer; Duryea, Ryan

doi:10.1186/s12911-019-0837-5

Cited by 21 publications

(8 citation statements)

References 22 publications

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“…Amongst the various classification systems used, mappings exist between them to ensure the interpretability of results across multiple systems and globally across time. Furthermore, as the healthcare CDM space is still actively developing, we will have the option of migrating our database to a CDM [ 42 ].…”

Section: Discussionmentioning

confidence: 99%

Development of a real-world database for asthma and COPD: The SingHealth-Duke-NUS-GSK COPD and Asthma Real-World Evidence (SDG-CARE) collaboration

Lam

Fang

Koh

et al. 2023

BMC Med Inform Decis Mak

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Purpose The SingHealth-Duke-GlaxoSmithKline COPD and Asthma Real-world Evidence (SDG-CARE) collaboration was formed to accelerate the use of Singaporean real-world evidence in research and clinical care. A centerpiece of the collaboration was to develop a near real-time database from clinical and operational data sources to inform healthcare decision making and research studies on asthma and chronic obstructive pulmonary disease (COPD). Methods Our multidisciplinary team, including clinicians, epidemiologists, data scientists, medical informaticians and IT engineers, adopted the hybrid waterfall-agile project management methodology to develop the SingHealth COPD and Asthma Data Mart (SCDM). The SCDM was developed within the organizational data warehouse. It pulls and maps data from various information systems using extract, transform and load (ETL) pipelines. Robust user testing and data verification was also performed to ensure that the business requirements were met and that the ETL pipelines were valid. Results The SCDM includes 199 data elements relevant to asthma and COPD. Data verification was performed and found the SCDM to be reliable. As of December 31, 2019, the SCDM contained 36,407 unique patients with asthma and COPD across the spectrum from primary to tertiary care in our healthcare system. The database updates weekly to add new data of existing patients and to include new patients who fulfil the inclusion criteria. Conclusions The SCDM was systematically developed and tested to support the use RWD for clinical and health services research in asthma and COPD. This can serve as a platform to provide research and operational insights to improve the care delivered to our patients.

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Section: Discussionmentioning

confidence: 99%

Development of a real-world database for asthma and COPD: The SingHealth-Duke-NUS-GSK COPD and Asthma Real-World Evidence (SDG-CARE) collaboration

Lam

Fang

Koh

et al. 2023

BMC Med Inform Decis Mak

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“…The raw data were converted to a standardized format (Generalized Data Model [ 16 ]). Jigsaw software (Outcomes Insights, Inc., Agoura Hills, CA) was used to extract all data for analysis.…”

Section: Methodsmentioning

confidence: 99%

The rate, cost and outcomes of parathyroidectomy in the united states dialysis population from 2016–2018

Danese¹,

Fox

Duryea³

et al. 2022

BMC Nephrol

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Background In end-stage kidney disease, patients may undergo parathyroidectomy if secondary hyperparathyroidism cannot be managed medically. This study was designed to estimate the parathyroidectomy rate in the United States (US) and to quantify changes in costs and other outcomes after parathyroidectomy. Methods This was a retrospective observational cohort study using US Renal Data System data for 2015–2018. Parathyroidectomy rates were estimated for adult hemodialysis and peritoneal dialysis patients alive at the beginning of 2016, 2017, and 2018 who were followed for a year or until parathyroidectomy, death, or transplant. Incremental differences in economic and clinical outcomes were compared before and after parathyroidectomy in adult hemodialysis and peritoneal dialysis patients who received a parathyroidectomy in 2016 and 2017. Results The rate of parathyroidectomy per 1,000 person-years decreased from 6.5 (95% CI 6.2-6.8) in 2016 to 5.3 (95% CI 5.0-5.6) in 2018. The incremental increase in 12-month cost after versus before parathyroidectomy was $25,314 (95% CI $23,777-$27,078). By the second month after parathyroidectomy, 58% of patients had a corrected calcium level < 8.5 mg/dL. In the year after parathyroidectomy (versus before), hospitalizations increased by 1.4 per person-year (95% CI 1.3-1.5), hospital days increased by 12.1 per person-year (95% CI 11.2-13.0), dialysis visits decreased by 5.2 per person-year (95% CI 4.4-5.9), and office visits declined by 1.3 per person-year (95% CI 1.0-1.5). The incremental rate per 1,000 person years for hematoma/bleed was 224.4 (95% CI 152.5-303.1), for vocal cord paralysis was 124.6 (95% CI 59.1-232.1), and for seroma was 27.4 (95% CI 0.4-59.0). Conclusions Parathyroidectomy was a relatively uncommon event in the hemodialysis and peritoneal dialysis populations. The incremental cost of parathyroidectomy was mostly attributable to the cost of the parathyroidectomy hospitalization. Hypocalcemia occurred in over half of patients, and calcium and phosphate levels were reduced. Clinicians, payers, and patients should understand the potential clinical and economic outcomes when considering parathyroidectomy.

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“…Future research should investigate the feasibility of a common data framework, such as the Generalized Data Model proposed by Danese et al 21 to facilitate the systematic and standardized capture of information in health insurance registries. However, access to some registry data elements may be subject to privacy legislation, and data are primarily collected for administrative, not research, purposes.…”

Section: Future Researchmentioning

confidence: 99%

Population coverage of the Canadian Chronic Disease Surveillance System: a survey of the contents of health insurance registries across Canada

Hamm

Robitaille

Ellison

et al. 2021

Health Promot Chronic Dis Prev Can

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Introduction Health insurance registries, which capture insurance coverage and demographic information for entire populations, are a critical component of population health surveillance and research when using administrative data. Lack of standardization of registry information across Canada’s provinces and territories could affect the comparability of surveillance measures. We assessed the contents of health insurance registries across Canada to describe the populations covered and document registry similarities and differences. Methods A survey about the data and population identifiers in health insurance registries was developed by the study team and representatives from the Public Health Agency of Canada. The survey was completed by key informants from most provinces and territories and then descriptively analyzed. Results Responses were received from all provinces; partial responses were received from the Northwest Territories. Demographic information in health insurance registries, such as primary address, date of birth and sex, were captured in all jurisdictions. Data captured on familial relationships, ethnicity and socioeconomic status varied among jurisdictions, as did start and end dates of coverage and frequency of registry updates. Identifiers for specific populations, such as First Nations individuals, were captured in some, but not all jurisdictions. Conclusion Health insurance registries are a rich source of information about the insured populations of the provinces and territories. However, data heterogeneity may affect who is included and excluded in population surveillance estimates produced using administrative health data. Development of a harmonized data framework could support timely and comparable population health research and surveillance results from multi-jurisdiction studies.

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The Generalized Data Model for clinical research

Cited by 21 publications

References 22 publications

Development of a real-world database for asthma and COPD: The SingHealth-Duke-NUS-GSK COPD and Asthma Real-World Evidence (SDG-CARE) collaboration

Development of a real-world database for asthma and COPD: The SingHealth-Duke-NUS-GSK COPD and Asthma Real-World Evidence (SDG-CARE) collaboration

The rate, cost and outcomes of parathyroidectomy in the united states dialysis population from 2016–2018

Population coverage of the Canadian Chronic Disease Surveillance System: a survey of the contents of health insurance registries across Canada

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