Dataset Information

A comparative effectiveness study of eSource used for data capture for a clinical research registry.

ABSTRACT:

Objective

This pilot study compared eSource-enabled versus traditional manual data transcription (non-eSource methods) for the collection of clinical registry information. The primary study objective was to compare the time spent completing registry forms using eSource versus non-eSource methods The secondary objectives were to compare data quality associated with these two data capture methods and the flexibility of the workflows. This study directly addressed fundamental questions relating to eSource adoption: what time-savings can be realized, and to what extent does eSource improve data quality.

Materials and methods

The study used time and motion methods to compare eSource versus non-eSource data capture workflows for a single center OB/GYN registry. Direct observation by industrial engineers using specialized computer software captured keystrokes, mouse clicks and video recordings of the study team in their normal work environment completing real-time data collection.

Results

The overall average data capture time was reduced with eSource versus non-eSource methods (difference, 151s per case; eSource, 1603s; non-eSource, 1754s; p=0.051). The average data capture time for the demographic data was reduced (difference, 79s per case; eSource, 133s; non-eSource, 213s; p<0.001). This represents a 37% time reduction (95% confidence interval 27% to 47%). eSourced data field transcription errors were also reduced (eSource, 0%; non-eSource, 9%).

Conclusion

The use of eSource versus traditional data transcription was associated with a significant reduction in data entry time and data quality errors. Further studies in other settings are needed to validate these results.

SUBMITTER: Nordo AH

PROVIDER: S-EPMC5942198 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Comparative effectiveness research (CER) calls for substantial changes in the way clinical research is conducted, interpreted and practically applied in the USA, in order to produce useful clinical evidence. Departing from classic efficacy and effectiveness research, the evolving CER paradigm requires structural and substantive innovations that address three basic questions: what works? for whom? and in whose hands? Addressing these questions will require fundamental changes in the approach to clinical research that include: the use of active treatments (or comparators) versus placebos in the comparisons of treatments, innovative or 'alternative' research methods, the specification and a priori design of studies to account for important subgroups, accounting for the nested nature of healthcare delivery in design and analysis of CER, the simultaneous study of multiple treatments or treatment modalities, the study of multiple outcomes (benefits and harms) for each treatment compared, and the reassessment of the value of different study designs in the hierarchy of collective 'evidence'. In order to aid individual providers and patients in making informed, personalized treatment decisions, guided by the best evidence possible, CER studies must generalize to a broad range of subgroups reflecting the spectrum of patients, providers and health systems that populate real-world practice settings. Without expansion in the scope, conduct and subsequent interpretation of clinical research reflected in the issues outlined above, CER will fall short of its potential for informing evidence-based practice and personalized medicine. The current paradigm for conducting, interpreting and applying clinical research does not meet the needs of optimal generalizability and application to individual physician-patient efforts to identify the most effective treatment, and therefore does not support the basic requirements of CER. The proposed changes should neither require decades nor exorbitant budgets to achieve. Using two examples, prostate cancer, and comparisons of single medications, we illustrated how the proposed changes in clinical research, matching strategy to each application, might be addressed.

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