RWE in the Journals

From Benjaminhughes.net

Contents

Q1 2014 Summary

  • PCORI/eGEM guys released further information on the HMORN virtual research network; up to 16.5m lives and 284 publications
  • First publication I have seen on Salford large scale pragmatic trial. Really details the effort that GSK had to go to get this to work and potential learning for LABS style approaches
  • More on information governance and security; HIPPA breaches yes, but significant pieces on anonymiation with IBM active in space; There was a lot on this last year too
  • Some other piece on RWE best practice and interesting studies in Diabetes/MS/Oncology – have not read these in detail but made it to my read later list.

Distributed query pilots:

The HMO Research Network Virtual Data Warehouse: A Public Data Model to Support Collaboration Ross et al., Generating Evidence, 2014...... by health care providers. An electronic health record (EHR) might organize and store data in a way that facilitates the rapid display of all information about a particular patient to meet the needs of a clinician. For these reasons ...

Query Health: standards-based, cross-platform population health surveillance Klann et al., Journal of the American …, 2014 ... C-CDA is used to produce reports of patient data, and QDM defines data elements required for clinical quality measures (CQMs).29 ,30 The reason for using this approach is summarized well in the 2014 Electronic Health Record (EHR) Certification Final Rule: 'this standard ...

Pragmatic trials:

Obtaining real-world evidence: the Salford Lung Study New et al., Thorax, 2014. We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can ...

Information governance & privacy:

US health information breaches up 137% Collier - Canadian Medical Association Journal, 2014. ... confidence,” states the report. “In health care, that risk is not limited to an individual hospital, provider, or business associate. It is an industry-wide threat to the success of the electronic health record initiative.”. The most common causes ...

Toward smarter healthcare: Anonymizing medical data to support research studies Gkoulalas-Divanis et al.,IBM Journal of Research and Development, 2014 ... Large amounts of structured medical data, such as those derived from Electronic Health Record (EHR) systems, need to be disseminated in a privacy-preserving way (for unstructured data privacy issues, we refer to [15]). This is, however, challenging for three reasons. ...

De-Identification of health records using< i> Anonym</i>: Effectiveness and robustness across datasets Zuccon et al., Artificial Intelligence in Medicine, 2014 Evaluate the effectiveness and robustness of Anonym, a tool for de-identifying free-text health records based on conditional random fields classifiers informed.

[http://scholar.google.com/scholar_url?hl=en&q=http://www.sciencedirect.com/science/article/pii/S1532046414000021&sa=X&scisig=AAGBfm1TDI0Jz3SZZVrIaWJijAEu0ohg3A&oi=scholaralrt A Data Recipient Centered De-identification Method to Retain Statistical Attributes] Gal et al., Journal of Biomedical Informatics, 2014 ... providers. As a result of the recent advances in information technology and the government's push for the use of Electronic Health Record (EHR) systems, a large amount of medical data is collected and stored electronically. ...

Leverage of database for RWE:

METHODOLOGICAL CHALLENGES IN EVALUATING THE VALUE OF REGISTERS Taylor et al., International Journal of …, 2014.

Research on drug safety and effectiveness using pharmacoepidemiological databases M Andersen - Journal of Internal Medicine, 2014... which should be dealt with by additional adjustment procedures. Electronic health record databases in pharmacogenetic research Variability in drug response may to a considerable degree affect the benefit-risk balance of drugs and ...

A Questionnaire to Assess the Relevance and Credibility of Observational Studies to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Berger et al., Value in Health, 2014. Evidence-based health care decisions are best informed by comparisons of all relevant interventions used to treat conditions in specific patient populations. Ob.

Comparison of Random Forest and Parametric Imputation Models for Imputing Missing Data Using MICE: A CALIBER Study Shah et al.,American Journal of …, 2014... MICE is one of the recommended methods for multiple imputation in electronic health-record data, and we have shown that standard parametric MICE and our new random forest MICE method work reasonably well under artificially introduced missingness at random in a ...

Diabetes

[http://scholar.google.com/scholar_url?hl=en&q=http://downloads.hindawi.com/journals/bmri/2014/781670.pdf&sa=X&scisig=AAGBfm1s_ZeNPRQo0bM8dVL0fl1m8nu1JA&oi=scholaralrt Impact of HbA1c Measurement on Hospital Readmission Rates: Analysis of 70,000 Clinical Database Patient Records Strack et al., BioMed Research …, 2014 ... records across hospitals throughout the United States. Health Facts is a voluntary program offered to organizations which use the Cerner Electronic Health Record System. The database contains data systematically collected ...

Oncology

[http://scholar.google.com/scholar_url?hl=en&q=http://www.jop.ascopubs.org/content/10/2/93.abstract&sa=X&scisig=AAGBfm09Kun6YN16PA1ibEiOavaYjLjERw&oi=scholaralrt Actionable Data Analytics in Oncology: Are We There Yet? Barkley et al, Journal of Oncology Practice, 2014 ... Data capabilities are viewed as distinct from electronic medical record/electronic health record adoption. In other words, electronic medical record/electronic health record adoption did not of itself indicate that a provider had data analytic capabilities. ...

MS

Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010 Oleen-Burkey et al., BMC Neurology, 2014 ... All retrospective database analyses are subject to certain limitations, and the results of this study must be interpreted with appropriate consideration of these limitations. Claims data are collected primarily for payment purposes, not research, and are subject to coding errors. ...

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