Guidance to reinforce the credibility of health care database studies and ensure their appropriate impact

Bate, Andrew

doi:10.1002/pds.4305

Cited by 11 publications

(7 citation statements)

References 20 publications

(32 reference statements)

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“…Therefore, before pooling data through meta-analysis (MA), validity remains a crucial aspect of study design and conception. [25][26][27][28] In particular, validation of the diagnoses is critical in the diabetes area, especially when in multinational epidemiological studies, 29 because the lack of clinical data may compromise optimal algorithms for patients' and outcomes' iden-…”

Section: Administrative Claims Databases: Validity Firstmentioning

confidence: 99%

Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?

Raschi

Poluzzi

Fadini

et al. 2018

Diabetes Obesity Metabolism

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Sodium glucose co‐transporter‐2 inhibitors have attracted the interest of the scientific community following the results from dedicated cardiovascular outcome trials, which demonstrated remarkable reduction in all‐cause mortality and other cardiovascular (CV) endpoints with empagliflozin and canagliflozin. These impressive results raised further expectations on real world data from large observational cohort studies. They were designed to address the possible existence of a class effect, and the uncertainty on whether this benefit can be extended from secondary to primary CV prevention of patients with type 2 diabetes. In this review, we collated data from existing observational studies (including the celebrated CVD‐REAL cohorts) and critically appraised results and methodological issues with the aim of providing clinical insight, including unsettled aspects, and proposing a research agenda for future investigations.

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Section: Administrative Claims Databases: Validity Firstmentioning

confidence: 99%

Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?

Raschi

Poluzzi

Fadini

et al. 2018

Diabetes Obesity Metabolism

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“…It is also possible that social isolation due to hearing loss could contribute to the development of AD. There is also the strong possibility that both diseases have a common cause and that hearing loss is simply an early condition indicative of the underlying pathology [6,[43][44][45][46].…”

Section: Discussionmentioning

confidence: 99%

Exploring prior diseases associated with incident late-onset Alzheimer’s disease dementia

et al. 2020

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Studies have identified prior conditions associated with late-onset Alzheimer's disease dementia (LOAD), but all prior diseases have rarely been screened simultaneously in the literature. Our objective in the present study was to identify prior conditions associated with LOAD and construct pathways for them. We conducted a population-based matched casecontrol study based on data collected in the National Health Insurance Research database of Taiwan and the Catastrophic Illness Certificate database for the years 1997-2013. Prior diseases definitions were based on the first three digits of the codes listed in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Inclusion criteria required that each ICD-code existed for at least 1 year and incurred at least 2 outpatient visits or inpatient diagnosis. The case group comprised 4,600 patients newly diagnosed with LOAD in 2007-2013. The LOAD patients were matched by sex and age to obtain 4,600 controls. Using stepwise multivariate logistic regression analysis, diseases were screened for 1, 2. . ., 9 years prior to the first diagnosis of LOAD. Path analysis was used to construct pathways between prior diseases and LOAD. Our results revealed that the following conditions were positively associated with the incidence of LOAD: anxiety (ICD-code 300), functional digestive disorder (ICD code 564), psychopathology-specific symptoms (ICD-code 307), disorders of the vestibular system (ICD-code 386), concussion (ICD-code 850), disorders of the urethra and urinary tract (ICD-code 599), disorders of refraction and accommodation (ICD-code 367), and hearing loss (ICD-code 389). A number of the prior diseases have previously been described in the literature in a manner identical to that in the present study. Our study supports the assertion that mental, hearing, vestibular system, and functional digestive disorders may play an important role in the pathogenesis of LOAD.

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“…There are guidelines on the reporting of observational studies, 42,43 and these are applicable to the analyses of networks of observational databases, but additional guidance is needed for analyses across networks of observational databases. 44 The same applies to Guidelines on Good Pharmacoepidemiology Practice 45 and the more specific recommendations for pharmacoepidemiology database studies by Hall et al 46 and other guidance on the use of databases for other applications such as Comparable Effectiveness Research. 47,48 While the area of networked observational data analysis across decentralized networks of data is novel, there has been extensive research and guidelines in more matured research fields looking at how to conduct analysis across multiple datasets without necessarily having access to patient-level data.…”

Section: Introductionmentioning

confidence: 96%

“…By comparison, there is unsurprisingly, given the newness of the field, a very limited guidance literature on the use of distributed noncentralized networks of observational databases. There are guidelines on the reporting of observational studies, and these are applicable to the analyses of networks of observational databases, but additional guidance is needed for analyses across networks of observational databases . The same applies to Guidelines on Good Pharmacoepidemiology Practice and the more specific recommendations for pharmacoepidemiology database studies by Hall et al and other guidance on the use of databases for other applications such as Comparable Effectiveness Research …”

Section: Introductionmentioning

confidence: 99%

Lessons from meta‐analyses of randomized clinical trials for analysis of distributed networks of observational databases

Bate

Chuang‐Stein²,

Roddam

et al. 2018

Pharmaceutical Statistics

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Networks of constellations of longitudinal observational databases, often electronic medical records or transactional insurance claims or both, are increasingly being used for studying the effects of medicinal products in real‐world use. Such databases are frequently configured as distributed networks. That is, patient‐level data are kept behind firewalls and not communicated outside of the data vendor other than in aggregate form. Instead, data are standardized across the network, and queries of the network are executed locally by data partners, and summary results provided to a central research partner(s) for amalgamation, aggregation, and summarization. Such networks can be huge covering years of data on upwards of 100 million patients. Examples of such networks include the FDA Sentinel Network, ASPEN, CNODES, and EU‐ADR. As this is a new emerging field, we note in this paper the conceptual similarities and differences between the analysis of distributed networks and the now well‐established field of meta‐analysis of randomized clinical trials (RCTs). We recommend, wherever appropriate, to apply learnings from meta‐analysis to help guide the development of distributed network analyses of longitudinal observational databases.

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Guidance to reinforce the credibility of health care database studies and ensure their appropriate impact

Cited by 11 publications

References 20 publications

Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?

Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?

Exploring prior diseases associated with incident late-onset Alzheimer’s disease dementia

Lessons from meta‐analyses of randomized clinical trials for analysis of distributed networks of observational databases

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