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BACKGROUND: The use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real-World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data. METHODS: The ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave. RESULTS: By December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status. CONCLUSIONS: Documentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi-institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows. PLAIN LANGUAGE SUMMARY: Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.
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Background: Physician mothers face many barriers in their ability to meet their lactation goals. This is often due to short maternity leaves and an often busy, inflexible work schedule at the time of return to work. We aimed to characterize the effect of using wireless, wearable breast pumps in the workplace and determine if these devices may help overcome barriers to breastfeeding success for physician mothers. Methods: A cross-sectional survey was distributed to female physicians and trainees identified through the group "Doctor Mothers Interested in Lactation Knowledge (Dr. MILK)" using an anonymous, Qualtrics® survey on the group's social media site. Participants were analyzed in two groups: those who had used wearable pumps versus those who had only used traditional breast pumps. Results: Of the 542 respondents analyzed, 321 (59%) had used a wearable pump in the workplace and 221 (41%) had only used a traditional electric breast pump. Those who had used a wearable pump reported statistically significant shorter lactation breaks (p < 0.00001) and were more likely to be able to provide breast milk to their infants for their entire intended duration (p = 0.005) compared to the traditional pump group. The ability to pump as often as needed while at work (p = 0.16) and the frequency of lactation breaks throughout the day (p = 0.223) were not significantly different when comparing the two groups. Conclusions: This study demonstrates a benefit to using wearable breast pumps for women physicians as they return to work after maternity leave. Utilization of these new wearable pumps correlates with shorter lactation breaks and the ability of physician mothers to provide breast milk to their infants for their intended duration.