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Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

ABSTRACT: The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices.Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views.37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country.There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

SUBMITTER: McCowan C

PROVIDER: S-EPMC4619877 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

McCowan Colin C Thomson Elizabeth E Szmigielski Cezary A CA Kalra Dipak D Sullivan Frank M FM Prokosch Hans-Ulrich HU Dugas Martin M Ford Ian I

BioMed research international 20151011

<h4>Background</h4>The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices.<h4>Methods</h4>Senior figures in healthcare org ...[more]

PMID: 26539523

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Project description:BackgroundUnnecessary healthcare utilization, non-adherence to current clinical guidelines, or insufficient personalized care are perpetual challenges and remain potential major cost-drivers for healthcare systems around the world. Implementing decision support systems into clinical care is promised to improve quality of care and thereby yield substantial effects on reducing healthcare expenditure. In this article, we evaluate the economic impact of clinical decision support (CDS) interventions based on electronic health records (EHR).MethodsWe searched for studies published after 2014 using MEDLINE, CENTRAL, WEB OF SCIENCE, EBSCO, and TUFTS CEA registry databases that encompass an economic evaluation or consider cost outcome measures of EHR based CDS interventions. Thereupon, we identified best practice application areas and categorized the investigated interventions according to an existing taxonomy of front-end CDS tools.Results and discussionTwenty-seven studies are investigated in this review. Of those, twenty-two studies indicate a reduction of healthcare expenditure after implementing an EHR based CDS system, especially towards prevalent application areas, such as unnecessary laboratory testing, duplicate order entry, efficient transfusion practice, or reduction of antibiotic prescriptions. On the contrary, order facilitators and undiscovered malfunctions revealed to be threats and could lead to new cost drivers in healthcare. While high upfront and maintenance costs of CDS systems are a worldwide implementation barrier, most studies do not consider implementation cost. Finally, four included economic evaluation studies report mixed monetary outcome results and thus highlight the importance of further high-quality economic evaluations for these CDS systems.ConclusionCurrent research studies lack consideration of comparative cost-outcome metrics as well as detailed cost components in their analyses. Nonetheless, the positive economic impact of EHR based CDS interventions is highly promising, especially with regard to reducing waste in healthcare.

Project description:ObjectivesThe use of electronic health record (EHR)-embedded child abuse clinical decision support (CA-CDS) may help decrease morbidity from child maltreatment. We previously reported on the development of CA-CDS in Epic and Allscripts. The objective of this study was to implement CA-CDS into Epic and Allscripts and determine its effects on identification, evaluation, and reporting of suspected child maltreatment.Materials and methodsAfter a preimplementation period, CA-CDS was implemented at University of Wisconsin (Epic) and Northwell Health (Allscripts). Providers were surveyed before the go-live and 4 months later. Outcomes included the proportion of children who triggered the CA-CDS system, had a positive Child Abuse Screen (CAS) and/or were reported to Child Protective Services (CPS).ResultsAt University of Wisconsin (UW), 3.5% of children in the implementation period triggered the system. The CAS was positive in 1.8% of children. The proportion of children reported to CPS increased from 0.6% to 0.9%. There was rapid uptake of the abuse order set.At Northwell Health (NW), 1.9% of children in the implementation period triggered the system. The CAS was positive in 1% of children. The child abuse order set was rarely used. Preimplementation, providers at both sites were similar in desire to have CA-CDS system and perception of CDS in general. After implementation, UW providers had a positive perception of the CA-CDS system, while NW providers had a negative perception.DiscussionCA-CDS was able to be implemented in 2 different EHRs with differing effects on clinical care and provider feedback. At UW, the site with higher uptake of the CA-CDS system, the proportion of children who triggered the system and the rate of positive CAS was similar to previous studies and there was an increase in the proportion of cases of suspected abuse identified as measured by reports to CPS. Our data demonstrate how local environment, end-users' opinions, and limitations in the EHR platform can impact the success of implementation.ConclusionsWhen disseminating CA-CDS into different hospital systems and different EHRs, it is critical to recognize how limitations in the functionality of the EHR can impact the success of implementation. The importance of collecting, interpreting, and responding to provider feedback is of critical importance particularly with CDS related to child maltreatment.

Project description:IntroductionTo evaluate unmet clinical need in unselected hypertrophic cardiomyopathy (HCM) patients to determine the risk of a wide range of subsequent cardiovascular disease endpoints and safety endpoints relevant for trial design.MethodsPopulation based cohort (CALIBER, linked primary care, hospital and mortality records in England, period 1997-2010), all people diagnosed with HCM were identified and matched by age, sex and general practice with ten randomly selected people without HCM. Random-effects Poisson models were used to assess the associations between HCM and cardiovascular diseases and bleeding.ResultsAmong 3,290,455 eligible people a diagnosis of hypertrophic cardiomyopathy was found in 4 per 10,000. Forty-one percent of the 1,160 individuals with hypertrophic cardiomyopathy were women and the median age was 57 years. The median follow-up was 4.0 years. Compared to general population controls, people with HCM had higher risk of ventricular arrhythmia (incidence rate ratio = 23.53, [95% confidence interval 12.67-43.72]), cardiac arrest or sudden cardiac death (6.33 [3.69-10.85]), heart failure (4.31, [3.30-5.62]), and atrial fibrillation (3.80 [3.04-4.75]). HCM was also associated with a higher incidence of myocardial infarction ([MI] 1.90 [1.27-2.84]) and coronary revascularisation (2.32 [1.46-3.69]).The absolute Kaplan-Meier risks at 3 years were 8.8% for the composite endpoint of cardiovascular death or heart failure, 8.4% for the composite of cardiovascular death, stroke or myocardial infarction, and 1.5% for major bleeding.ConclusionsOur study identified major unmet need in HCM and highlighted the importance of implementing improved cardiovascular prevention strategies to increase life-expectancy of the contemporary HCM population. They also show that national electronic health records provide an effective method for identifying outcomes and clinically relevant estimates of composite efficacy and safety endpoints essential for trial design in rare diseases.

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Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

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Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

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