Generating real-world evidence: Using automated data extraction to replace manual chart review.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18096-e18096 ◽  
Author(s):  
Jennifer H. Law ◽  
Christopher Pettengell ◽  
Lisa W Le ◽  
Steven Aviv ◽  
Patricia DeMarco ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Data ◽  
Real World ◽  
Chart Review ◽  
Clinical Decision Making ◽  
Data Extraction ◽  
Clinical Care ◽  
Data Abstraction ◽  
Real World Evidence

e18096 Background: Real world evidence is a valuable resource to help guide clinical care beyond evidence generated from clinical trials, for example safety and effectiveness of novel treatments in special populations. Administrative databases often lack sufficient clinical detail to address gaps in the improvement of patient management and quality of care. Detailed clinical data collection and curation are resource intensive, limiting the ability to generate and maintain large informative cancer databases. Darwen, novel technology developed by Pentavere, enables the automation of data abstraction from unstructured hospital electronic medical records and may eliminate the need for manual chart review. Methods: Health records were identified through an institutional cancer registry from patients with stage IIIB/IV lung cancer (NSCLC or SCLC) diagnosed and treated at the Princess Margaret Cancer Centre between 01/01/2015 and 31/12/2017. Cases underwent automated data extraction including demographics, comorbidities, treatment, concurrent medications and outcomes until 30/06/2018. Agreement with data fields extracted using manual data collection in an external validation set of patients is planned. Results: Of 1210 patients identified, 538 were eligible for analysis. From automated data abstraction, 9.9% were reported to have SCLC, 67.5% adenocarcinoma, 11.2% squamous carcinoma, 28% EGFR mutations, 5.8% ALK fusions and 9.3% tumour PDL1 > = 50%. Of the 304 (56.5%) that received systemic therapy, initial treatment was chemotherapy for 55.6%, targeted therapy in 34.2% and immunotherapy in 10.2%. Additional outcome data and agreement with manually curated data fields will be presented. Conclusions: Automated software to extract clinical data is a powerful new tool to generate and maintain databases that yield high quality real world clinical evidence. This is a critical next step to improve clinical decision making, inform evidence-based practice and improve quality of cancer care.

scholarly journals Allergen immunotherapy: the growing role of observational and randomised trial “real-world evidence”

2021 ◽  
Author(s):  
Giovanni Paoletti ◽  
Danilo Di Bona ◽  
Derek Chu ◽  
Davide Firinu ◽  
Enrico Heffler ◽  
...  
Keyword(s):  
Real World ◽  
Allergen Immunotherapy ◽  
Clinical Decision Making ◽  
Randomised Trial ◽  
Unmet Need ◽  
Real Life ◽  
Real World Data ◽  
Level Of Evidence ◽  
Real World Evidence

Although there is a considerable body of knowledge about allergen immunotherapy (AIT), there is a lack of data on the reliability of real-world evidence (RWE) in AIT and consequently, a lack of information on how AIT effectively works in real life. To address the current unmet need for an appraisal of the quality of RWE in AIT, the European Academy of Allergy and Clinical Immunology Methodology Committee recently initiated a systematic review of observational studies of AIT, which will use the RELEVANT tool and the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) to rate the quality of the evidence base as a whole. The next step will be to develop a broadly applicable, pragmatic “real-world” database using systematic data collection. Based on the current RWE base, and perspectives and recommendations of authorities and scientific societies, a hierarchy of RWE in AIT is proposed, which places pragmatic trials and registry data at the positions of highest level of evidence. There is a need to establish more AIT registries that collect data in a cohesive way, using standardised protocols. This will provide an essential source of real-world data that can be easily shared, promoting evidence-based research and quality improvement in study design and clinical decision-making.

scholarly journals The quality of research with real-world evidence

2019 ◽  
pp. 39-41
Author(s):  
Mauricio Palacios Gómez
Keyword(s):  
Clinical Trials ◽  
Clinical Data ◽  
Real World ◽  
Clinical Care ◽  
Medical Science ◽  
Clinical Information ◽  
Real World Data ◽  
Real World Evidence ◽  
Definition Of ◽  
Time Required

Most of the medical practice has not been proven by controlled clinical trials, and there are no plans to conduct such trials in order to decrease clinician uncertainty. This happens partly due to the difficulty of making designs with scientific and ethical validity, the costs of this type of research and the time required to generate results, which can be several years. Clinical trials do not have the capability to generate information that allows to make decisions in some sectors of clinical care and public health, such as when an epidemic occurs. Therefore, medical science is based on observational studies, past practices and therapeutic tradition (1). Observation of clinical data that have defined a clinical behavior precedes the clinical trial. The knowledge about scurvy, the fact that this pathology is considered a nutritional deficiency and its treatment with citrus fruits, originated thanks to the collection of clinical data on sailors, soldiers and prisoners of the British Crown in the 18th and 19th centuries (2). This clinical information, which was collected uniformly and served to produce new knowledge, is what is now known as Real World Data (RWD). A modern definition of RWD would be one that talks about data obtained by any non-interventionist methodology that is collected prospectively and retrospectively from observations of routine clinical practice, and which comes from various sources including data from patients, doctors, hospitals, payers, social data, etc (3).

scholarly journals Italian Electronic Health Records Mapping: Is Clinical Data Collection Getting In Line With The Real World Evidence Era?

2016 ◽  
Vol 19 (7) ◽  
pp. A478
Author(s):  
A Avitabile ◽  
A Caputo ◽  
G Gilardelli ◽  
C Golotta ◽  
L La Grasta ◽  
...  
Keyword(s):  
Data Collection ◽  
Electronic Health Records ◽  
Clinical Data ◽  
Real World ◽  
Health Records ◽  
The Real ◽  
Real World Evidence ◽  
Electronic Health

scholarly journals Update on Data Reuse in Health Care

2017 ◽  
Vol 26 (01) ◽  
pp. 24-27 ◽  
Author(s):  
C. Safran
Keyword(s):  
Clinical Data ◽  
Legal Framework ◽  
Data Reuse ◽  
Policy Initiatives ◽  
Clinical Databases ◽  
Real World Evidence ◽  
Policy Frameworks ◽  
Potential Risks ◽  
Barriers To Use

Summary Objective: Reuse of clinical data has broad use in clinical, research, governmental, and business settings. This summary provides an update on the benefits, barriers to use with large clinical databases, policy frameworks that have been formulated, and challenges. Methods: This report highlights some recent publications on the diverse uses of clinical data and some policy initiatives to promote reuse. It also contains the opinions of the author. Results: Although many examples of the benefits of data reuse have been documented, this summary also reviews why the quality of clinical data needs to be the focus of future informatics work. Conclusion: The promise of reusing data outweighs potential risks, but concerns about privacy and the need to modernize our legal framework will be necessary to realize the full benefits of real-world evidence.

scholarly journals Awareness, Knowledge, and Utility of RCT Data vs RWE: Results From a Survey of US Cardiologists: Real-world Evidence in Clinical Decision Making

2020 ◽  
Vol 14 ◽  
pp. 117954682095341 ◽  
Author(s):  
Todd C Villines ◽  
Mark J Cziraky ◽  
Alpesh N Amin
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
The Body ◽  
Representative Sampling ◽  
Real World Evidence ◽  
Wide Range

Real-world evidence (RWE) provides a potential rich source of additional information to the body of data available from randomized clinical trials (RCTs), but there is a need to understand the strengths and limitations of RWE before it can be applied to clinical practice. To gain insight into current thinking in clinical decision making and utility of different data sources, a representative sampling of US cardiologists selected from the current, active Fellows of the American College of Cardiology (ACC) were surveyed to evaluate their perceptions of findings from RCTs and RWE studies and their application in clinical practice. The survey was conducted online via the ACC web portal between 12 July and 11 August 2017. Of the 548 active ACC Fellows invited as panel members, 173 completed the survey (32% response), most of whom were board certified in general cardiology (n = 119, 69%) or interventional cardiology (n = 40, 23%). The survey results indicated a wide range of familiarity with and utilization of RWE amongst cardiologists. Most cardiologists were familiar with RWE and considered RWE in clinical practice at least some of the time. However, a significant minority of survey respondents had rarely or never applied RWE learnings in their clinical practice, and many did not feel confident in the results of RWE other than registry data. These survey findings suggest that additional education on how to assess and interpret RWE could help physicians to integrate data and learnings from RCTs and RWE to best guide clinical decision making.

scholarly journals Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Andreas Straube ◽  
Philipp Stude ◽  
Charly Gaul ◽  
Katrin Schuh ◽  
Mirja Koch
Keyword(s):  
Quality Of Life ◽  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Real World ◽  
Treatment Patterns ◽  
Patient Profile ◽  
Real World Evidence ◽  
Patient Profiles ◽  
Treatment Responses

Abstract Background Erenumab, the first-in-class fully human monoclonal antibody targeting the calcitonin gene-related peptide receptor, was shown to be efficacious and safe for the prophylactic treatment of migraine in adults in randomized clinical trials. Large-scale, real-world evidence in multi-centre settings is still needed to confirm these results. Erenumab patient profiles outside clinical trials and physicians’ treatment patterns, as well as data from patients treated in Germany, a severely impacted population, are not published yet. Methods TELESCOPE was a multi-centre survey gathering real-world data from 45 German headache centres between July 2019 and December 2019. The project consisted of two parts. In the first part, treating physicians shared their experiences on current erenumab treatment with regard to patient profiles, treatment patterns and treatment responses. In the second part, a retrospective chart review was conducted of 542 migraine patients treated with erenumab for at least three months. Treatment responses focused on various aspects of patients’ quality of life. Results The analysis of 542 patients’ charts revealed that three-month treatment with erenumab significantly reduced monthly headaches, migraine and acute medication days. Furthermore, headache intensity and frequency were reduced in over 75 % and accompanying aura in 35 % of patients. The clinical global impression scale revealed a general improvement in 91 % of patients. According to the treating physicians’ professional judgement, 83 % of patients responded to erenumab and 80 % were satisfied with the treatment. Physicians evaluated restricted quality of life, the number of monthly migraine days and previous, prophylactic treatments as the main components of the current patient profile for monoclonal antibody recipients. Based on the assessment of physicians, erenumab reduced migraine symptoms in 65 % and increased quality of life in more than 75 % of their patients. Conclusions TELESCOPE confirms positive treatment responses with erenumab shown in clinical trials in a real-world multi-centre setting. The results show consistently positive experiences of physicians utilizing erenumab in clinical practice and underline that therapy with this monoclonal antibody is effective in migraine patients, particular in those, who have failed several prophylactic therapies.

OP117 Digital Real-World Evidence In Times Of General Data Protection Regulation

2021 ◽  
Vol 37 (S1) ◽  
pp. 1-1
Author(s):  
Rhodri Saunders ◽  
Rafael Torrejon Torres ◽  
Maximilian Blüher
Keyword(s):  
Data Collection ◽  
Real World ◽  
Data Protection ◽  
Safety Data ◽  
Design Approach ◽  
Data Set ◽  
General Data Protection Regulation ◽  
Real World Evidence ◽  
Quality Markers ◽  
General Data

IntroductionReal-world evidence (RWE) is a useful supplement to a product's evidence base especially for medical devices, which are often unsuitable for randomized controlled trials. Generally, RWE is analyzed retrospectively (for example, healthcare records), which lack granularity for health-economic analysis. Prospective collection of RWE in hospitals can promote device-specific endpoint assessment. The advent of the General Data Protection Regulation (GDPR) requires a privacy-by-design approach. This work describes a workflow for a GDPR-compliant device-specific RWE collection as part of quality improvement initiatives (QII).MethodsA literature review identifies relevant clinical and quality markers as endpoints to the investigated technology. A panel of experts grade these endpoints on their clinical significance, privacy sensitivity, analytic value, and feasibility for collection. Endpoints meeting a predefined cut-off are considered quality markers for the QII. Finally, an RWE data collection app is designed to collect the quality markers using either longitudinal, pseudonymized data or single time-point anonymized data to ensure data protection by design.ResultsUsing this approach relevant clinical markers were identified in a GDPR-compliant manner. The data collection app design ensured that patient data were protected, while maintaining minimum requirements on patient information and consent. The pilot QII collected data on over 5,000 procedures, which represents the largest single data set available for the tested technology. Due to its prospective nature this programme was the first to collect patient outcomes in sufficient quantity for analysis, while previous studies only recorded adverse events.ConclusionsGDPR and RWE can co-exist in harmony. A design approach, which has data protection in mind from the start can combine high quality RWE collection of efficacy and safety data with maximum patient privacy.

scholarly journals Assessing the quality of medication documentation: development and feasibility of the MediDocQ instrument for retrospective chart review in the hospital setting

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e034609 ◽  
Author(s):  
Antje Hammer ◽  
Anke Wagner ◽  
Monika A Rieger ◽  
Tanja Manser
Keyword(s):  
Development Process ◽  
Chart Review ◽  
Clinical Decision Making ◽  
Hospital Setting ◽  
Retrospective Chart Review ◽  
Medication Administration ◽  
Patient Records ◽  
Mean Values ◽  
Medication Documentation

ObjectiveThe medication process requires clear and transparent documentation in patient records. Incomplete or incorrect medication documentation may contribute to inappropriate clinical decision-making and adverse events. To comprehensively assess the quality of in-hospital medication documentation, we developed a retrospective chart review (RCR) instrument. We report on the development process, the feasibility of the instrument and describe our application of the instrument to a sample of patient records.DesignCross-sectional study using an RCR instrument to evaluate paper-based, non-standardised prescription and medication administration charts (MediDocQ).SettingTwo German university hospitals.ParticipantsRecords from 1361 patients admitted between April and July 2015 were evaluated.MethodsThe MediDocQ development process comprised six consecutive stages: focused literature review, web-based search, initial patient record screening, review by project advisory board, focus groups with professionals and pilot testing. The final 54-item RCR instrument covers three key components of medication documentation: (1) completeness of documented information (including prescription, medication administration and pro re nata (PRN) medication), (2) quality of transcriptions and (3) compliance with chart structure, legibility, handling of deletions and chart corrections. Descriptive statistics are presented as mean values, SD, median and interquartile ranges for individual items.ResultsOverall, 33 out of 54 items resulted in mean values above 0.75, indicating high-quality medication documentation. Documentation quality was particularly compromised for verbal and PRN orders (which involve more steps than standard orders) and when documentation was not completed at the same time as medication administration.ConclusionsMediDocQ is a patient safety instrument that can be used to evaluate the quality of medication documentation and identify components of the process where intervention is required. In our setting, standardisation of medication documentation, particularly regarding medication administration and PRN medication is a priority.

scholarly journals Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)

2018 ◽  
Vol 24 (1) ◽  
Author(s):  
Hun-Sung Kim ◽  
Sue Hyun Lee ◽  
Tong Min Kim ◽  
Ju Han Kim
Keyword(s):  
Clinical Data ◽  
Real World ◽  
Data Mart ◽  
Real World Evidence
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