Protecting blinded trials in electronic hospital systems.
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ABSTRACT:
SUBMITTER: Sydes MR
PROVIDER: S-EPMC9036147 | biostudies-literature | 2022 Apr
REPOSITORIES: biostudies-literature
Publications
Protecting blinded trials in electronic hospital systems.
Sydes Matthew R MR Wong Wai Keong WK Bakhai Ameet A Joffe Nicola N Love Sharon B SB
Clinical trials (London, England) 20220111 2
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Project description:ObjectiveElectronic health records (EHRs) were expected to yield numerous benefits. However, early studies found mixed evidence of this. We sought to determine whether widespread adoption of modern EHRs in the US has improved clinical care.MethodsWe studied hospitals reporting performance measures from 2008-2015 in the Centers for Medicare and Medicaid Services Hospital Compare database that also reported having an EHR in the American Hospital Association 2015 IT supplement. Using interrupted time-series analysis, we examined the association of EHR implementation, EHR vendor, and Meaningful Use status with 11 process measures and 30-day hospital readmission and mortality rates for heart failure, pneumonia, and acute myocardial infarction.ResultsA total of 1246 hospitals contributed 8222 hospital-years. Compared to hospitals without EHRs, hospitals with EHRs had significant improvements over time on 5 of 11 process measures. There were no substantial differences in readmission or mortality rates. Hospitals with CPSI EHR systems performed worse on several process and outcome measures. Otherwise, we found no substantial improvements in process measures or condition-specific outcomes by duration of EHR use, EHR vendor, or a hospital's Meaningful Use Stage 1 or Stage 2 status.ConclusionIn this national study of hospitals with modern EHRs, EHR use was associated with better process of care measure performance but did not improve condition-specific readmission or mortality rates regardless of duration of EHR use, vendor choice, or Meaningful Use status. Further research is required to understand why EHRs have yet to improve standard outcome measures and how to better realize the potential benefits of EHR systems.
| S-EPMC7647234 | biostudies-literature
Project description:BackgroundA previous census of electronic prescribing (EP) systems in England showed that more than half of hospitals with EP reported more than one EP system within the same hospital. Our objectives were to describe the rationale for having multiple EP systems within a single hospital, and to explore perceptions of stakeholders about the advantages and disadvantages of multiple systems including any impact on patient safety.MethodsHospitals were selected from previous census respondents. A decision matrix was developed to achieve a maximum variation sample, and snowball sampling used to recruit stakeholders of different professional backgrounds. We then used an a priori framework to guide and analyse semi-structured interviews.ResultsTen participants, comprising pharmacists and doctors and a nurse, were interviewed from four hospitals. The findings suggest that use of multiple EP systems was not strategically planned. Three co-existing models of EP systems adoption in hospitals were identified: organisation-led, clinician-led and clinical network-led, which may have contributed to multiple systems use. Although there were some perceived benefits of multiple EP systems, particularly in niche specialities, many disadvantages were described. These included issues related to access, staff training, workflow, work duplication, and system interfacing. Fragmentation of documentation of the patient's journey was a major safety concern.DiscussionThe complexity of EP systems' adoption and deficiencies in IT strategic planning may have contributed to multiple EP systems use in the NHS. In the near to mid-term, multiple EP systems may remain in place in many English hospitals, which may create challenges to quality and patient safety.
| S-EPMC6295095 | biostudies-literature
Project description:BACKGROUND: Collection and analysis of clinical data can help orthopaedic surgeons to practice evidence based medicine. Spreadsheets and offline relational databases are prevalent, but not flexible, secure, workflow friendly and do not support the generation of standardized and interoperable data. Additionally these data collection applications usually do not follow a structured and planned approach which may result in failure to achieve the intended goal. QUESTIONS/PURPOSES: Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system. WHERE ARE WE NOW?: Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems. WHERE DO WE NEED TO GO?: To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process. HOW DO WE GET THERE?: Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.
| S-EPMC3049639 | biostudies-literature
Project description:Administrators play a major role in choosing and managing the use of the electronic health record (EHR). The documentation policies and EHR changes enacted or approved by administrators affect the ability to use clinical data for research. This article illustrates the challenges that can be avoided through awareness of the consequences of customization, variations in documentation policies and quality, and user interface features. Solutions are posed that assist administrators in avoiding these challenges and promoting data harmonization for research and quality improvement.
| S-EPMC3714548 | biostudies-literature
Project description:Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.
| S-EPMC3554479 | biostudies-other
Project description:Prescribing errors are a source of preventable harm in healthcare, which may be mitigated using Electronic Prescribing (EP) systems. Anyone who routinely prescribes medication could benefit from digitally assisted automated checks to identify whether a prescription should potentially not be allowed (e.g. drug allergy). National Health Service (NHS) Trusts have implemented a range of EP systems; however, their performance has not hitherto been evaluated. We developed the web-based Electronic Prescribing Risk and Safety Evaluation (ePRaSE) tool, which comprises a bank of prescribing scenarios to evaluate the performance of EP systems. We solicited ePRaSE testing: 68 pharmacists from across 45 English NHS Trusts, utilising 13 different EP systems volunteered for the study. We found considerable variability in mitigation performance (systems correctly identifying risk of error when prescribing) across both NHS Trusts and EP systems. Moreover, we found that mitigation performance varied considerably across NHS Trusts using the same EP system, strongly suggesting there are opportunities to optimise performance within systems. The ePRaSE tool is effective in identifying variability in risk management between NHS Trusts and EP systems. Wider use of this tool may facilitate improvements in EP system configurations, thus minimising potential harm from prescribing errors.
| S-EPMC11736027 | biostudies-literature
Project description:ObjectivesTo identify interventions implemented in hospital electronic prescribing systems and the outcome measures used to monitor their impact.MethodsWe systematically searched CINAHL, EMBASE, Google Scholar and Medline using keywords in three strands: (i) population: hospital inpatient or emergency department; (ii) intervention: electronic prescribing functionality; and (iii) outcome: antimicrobial stewardship. The interventions were grouped into six themes: alerts, order sets, restriction of access, mandated documentation, embedded guidelines and automatic prescription stop. The outcome measures were organized into those that measure the quality or quantity of prescribing or clinical decision support (CDS) activity. The impact of each intervention reported was grouped into a positive, negative or no change.ResultsA total of 28 studies were eligible for inclusion. There were 28 different interventions grouped into the six themes. Alerts visible to the practitioner in the electronic health record (EHR) were most frequently implemented (n = 11/28). Twenty different outcome measures were identified, divided into quality (n = 13/20) and quantity outcomes (n = 4/20) and CDS activity (n = 3/20). One-third of outcomes reported across the 28 studies showed positive change (34.4%, n = 42/122) and 61.4% (n = 75/122) showed no change.ConclusionsThe most frequently implemented interventions were alerts, the majority of which were to influence behaviour or decision-making of the practitioner within the EHR. Quality outcomes were most frequently selected by researchers. The review supports previous research that larger well-designed randomized studies are needed to investigate the impact of interventions on AMS and outcome measures to be standardized.
| S-EPMC9237448 | biostudies-literature
Project description:Background and objectivesElectronic healthcare records have become central to patient care. Evaluation of new systems include a variety of usability evaluation methods or usability metrics (often referred to interchangeably as usability components or usability attributes). This study reviews the breadth of usability evaluation methods, metrics, and associated measurement techniques that have been reported to assess systems designed for hospital staff to assess inpatient clinical condition.MethodsFollowing Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology, we searched Medline, EMBASE, CINAHL, Cochrane Database of Systematic Reviews, and Open Grey from 1986 to 2019. For included studies, we recorded usability evaluation methods or usability metrics as appropriate, and any measurement techniques applied to illustrate these. We classified and described all usability evaluation methods, usability metrics, and measurement techniques. Study quality was evaluated using a modified Downs and Black checklist.ResultsThe search identified 1336 studies. After abstract screening, 130 full texts were reviewed. In the 51 included studies 11 distinct usability evaluation methods were identified. Within these usability evaluation methods, seven usability metrics were reported. The most common metrics were ISO9241-11 and Nielsen's components. An additional "usefulness" metric was reported in almost 40% of included studies. We identified 70 measurement techniques used to evaluate systems. Overall study quality was reflected in a mean modified Downs and Black checklist score of 6.8/10 (range 1-9) 33% studies classified as "high-quality" (scoring eight or higher), 51% studies "moderate-quality" (scoring 6-7), and the remaining 16% (scoring below five) were "low-quality."ConclusionThere is little consistency within the field of electronic health record systems evaluation. This review highlights the variability within usability methods, metrics, and reporting. Standardized processes may improve evaluation and comparison electronic health record systems and improve their development and implementation.
| S-EPMC9438452 | biostudies-literature
Project description:VESPA Cohort: Vanderbilt Electronic Systems for Pharmacogenomic Assessment
| PRJNA296728 | ENA
Project description:ObjectiveEvent capture in clinical trials is resource-intensive, and electronic medical records (EMRs) offer a potential solution. This study develops algorithms for EMR-based death and hospitalization capture and compares them with traditional event capture methods.Materials and methodsWe compared the effectiveness of EMR-based event capture and site-captured events adjudicated by a clinical endpoint committee in the multi-center INfluenza Vaccine to Effectively Stop cardio Thoracic Events and Decompensated heart failure (INVESTED) trial for participants from the Veterans Affairs healthcare system. Varying time windows around event dates were used to optimize events matching. The algorithms were externally validated for heart failure hospitalizations in the Medical Information Mart for Intensive Care (MIMIC)-IV database.ResultsWe observed 100% sensitivity for death events with a 1-day window. Sensitivity for cardiovascular, heart failure, pulmonary, and nonspecific cardiopulmonary hospitalizations using discharge diagnosis codes varied between 75% and 95%. Including Centers for Medicare & Medicaid Services data improved sensitivity with no meaningful decrease in specificity. The MIMIC-IV analysis showed 82% sensitivity and 99% specificity for heart failure hospitalizations.DiscussionEMR-based method accurately identifies all-cause mortality and demonstrates high accuracy for cardiopulmonary hospitalizations. This study underscores the importance of optimal time windows, data completeness, and domain variability in EMR systems.ConclusionEMR-based methods are effective strategies for capturing death and hospitalizations in clinical trials; however, their effectiveness may be influenced by the complexity of events and domain variability across different EMR systems. Nonetheless, EMR-based methods can serve as a valuable complement to traditional methods.
| S-EPMC11756702 | biostudies-literature