Objectives The objective of this study is the conceptual design, implementation and evaluation of a system for generic, standard-compliant data transfer into electronic health records (EHRs). This includes patient data from clinical research and medical care that has been semantically annotated and enhanced with metadata. The implementation is based on the single-source approach. Technical and clinical feasibilities, as well as cost-benefit efficiency, were investigated in everyday clinical practice. Methods Münster University Hospital is a tertiary care hospital with 1,457 beds and 10,823 staff who treated 548,110 patients in 2018. Single-source metadata architecture transformation (SMA:T) was implemented as an extension to the EHR system. This architecture uses Model Driven Software Development (MDSD) to generate documentation forms according to the Clinical Data Interchange Standards Consortium (CDISC) operational data model (ODM). Clinical data are stored in ODM format in the EHR system database. Documentation forms are based on Google's Material Design Standard. SMA:T was used at a total of five clinics and one administrative department in the period from March 1, 2018 until March 31, 2019 in everyday clinical practice. Results The technical and clinical feasibility of SMA:T was demonstrated in the course of the study. Seventeen documentation forms including 373 data items were created with SMA:T. Those were created for 2,484 patients by 283 users in everyday clinical practice. A total of 121 documentation forms were examined retrospectively. The Constructive cost model (COCOMO II) was used to calculate cost and time savings. The form development mean time was reduced by 83.4% from 3,357 to 557 hours. Average costs per form went down from EUR 953 to 158. Conclusion Automated generic transfer of standard-compliant data and metadata into EHRs is technically and clinically feasible, cost efficient, and a useful method to establish comprehensive and semantically annotated clinical documentation. Savings of time and personnel resources are possible.

Multivariate predictive models have revealed promising results for the individual prediction of treatment response, relapse risk as well as for the differential diagnosis in affective disorders. Yet, in order to translate personalized predictive modelling from the research context to psychiatric clinical routine, standardized collection of information of sufficient detail and temporal resolution in day-to-day clinical care is needed, based on which machine learning algorithms can be trained. Digital collection of patient-reported outcomes (PROs) is a time- and cost-efficient approach to gain such data throughout the treatment course. However, it remains unclear whether patients with severe affective disorders are willing and able to participate in such efforts, whether the feasibility of such systems might vary depending on individual patient characteristics and if digitally acquired patient-reported outcomes are of sufficient diagnostic validity. To address these questions, we implemented a system for continuous digital collection of patient-reported outcomes via tablet computers throughout inpatient treatment for affective disorders at the Department of Psychiatry at the University of Muenster. 364 affective disorder patients were approached, 66.5% of which could be recruited to participate in the study. An average of four assessments were completed during the treatment course, none of the participants dropped out of the study prematurely. 89.3% of participants did not require additional support during data entry. Need of support with tablet handling and slower data entry pace was predicted by older age, whereas depression severity at baseline did not influence these measures. Patient-reported outcomes of depression severity showed high agreement with standardized external assessments by a clinical interviewer. Our results indicate that continuous digital collection of patient-reported outcomes is a feasible, accessible and valid method for longitudinal data collection in psychiatric routine, which will eventually facilitate the identification of individual risk and resilience factors for affective disorders and pave the way towards personalized psychiatric care.

Background Predictive models have revealed promising results for the individual prognosis of treatment response and relapse risk as well as for differential diagnosis in affective disorders. Yet, in order to translate personalized predictive modeling from research contexts to psychiatric clinical routine, standardized collection of information of sufficient detail and temporal resolution in day-to-day clinical care is needed. Digital collection of self-report measures by patients is a time- and cost-efficient approach to gain such data throughout treatment. Objective The objective of this study was to investigate whether patients with severe affective disorders were willing and able to participate in such efforts, whether the feasibility of such systems might vary depending on individual patient characteristics, and if digitally acquired assessments were of sufficient diagnostic validity. Methods We implemented a system for longitudinal digital collection of risk and symptom profiles based on repeated self-reports via tablet computers throughout inpatient treatment of affective disorders at the Department of Psychiatry at the University of Münster. Tablet-handling competency and the speed of data entry were assessed. Depression severity was additionally assessed by a clinical interviewer at baseline and before discharge. Results Of 364 affective disorder patients who were approached, 242 (66.5%) participated in the study; 88.8% of participants (215/242) were diagnosed with major depressive disorder, and 27 (11.2%) had bipolar disorder. During the duration of inpatient treatment, 79% of expected assessments were completed, with an average of 4 completed assessments per participant; 4 participants (4/242, 1.6%) dropped out of the study prematurely. During data entry, 89.3% of participants (216/242) did not require additional support. Needing support with tablet handling and slower data entry pace were predicted by older age, whereas depression severity at baseline did not influence these measures. Patient self-reporting of depression severity showed high agreement with standardized external assessments by a clinical interviewer. Conclusions Our results indicate that digital collection of self-report measures is a feasible, accessible, and valid method for longitudinal data collection in psychiatric routine, which will eventually facilitate the identification of individual risk and resilience factors for affective disorders and pave the way toward personalized psychiatric care.

Background Empirically driven personalized diagnostic applications and treatment stratification is widely perceived as a major hallmark in psychiatry. However, databased personalized decision making requires standardized data acquisition and data access, which are currently absent in psychiatric clinical routine. Objective Here, we describe the informatics infrastructure implemented at the psychiatric Münster University Hospital, which allows standardized acquisition, transfer, storage, and export of clinical data for future real-time predictive modelling in psychiatric routine. Methods We designed and implemented a technical architecture that includes an extension of the electronic health record (EHR) via scalable standardized data collection and data transfer between EHRs and research databases, thus allowing the pooling of EHRs and research data in a unified database and technical solutions for the visual presentation of collected data and analyses results in the EHR. The Single-source Metadata ARchitecture Transformation (SMA:T) was used as the software architecture. SMA:T is an extension of the EHR system and uses module-driven engineering to generate standardized applications and interfaces. The operational data model was used as the standard. Standardized data were entered on iPads via the Mobile Patient Survey (MoPat) and the web application Mopat@home, and the standardized transmission, processing, display, and export of data were realized via SMA:T. Results The technical feasibility of the informatics infrastructure was demonstrated in the course of this study. We created 19 standardized documentation forms with 241 items. For 317 patients, 6451 instances were automatically transferred to the EHR system without errors. Moreover, 96,323 instances were automatically transferred from the EHR system to the research database for further analyses. Conclusions In this study, we present the successful implementation of the informatics infrastructure enabling standardized data acquisition and data access for future real-time predictive modelling in clinical routine in psychiatry. The technical solution presented here might guide similar initiatives at other sites and thus help to pave the way toward future application of predictive models in psychiatric clinical routine.

BackgroundEmpirically driven personalized diagnostic and treatment is widely perceived as a major hallmark in psychiatry. However, databased personalized decision making requires standardized data acquisition and data access, which is currently absent in psychiatric clinical routine.ObjectiveHere we describe the informatics infrastructure implemented at the psychiatric university hospital Münster allowing for standardized acquisition, transfer, storage and export of clinical data for future real-time predictive modelling in psychiatric routine.MethodsWe designed and implemented a technical architecture that includes an extension of the EHR via scalable standardized data collection, data transfer between EHR and research databases thus allowing to pool EHR and research data in a unified database and technical solutions for the visual presentation of collected data and analyses results in the EHR. The Single-source Metadata ARchitecture Transformation (SMA:T) was used as the software architecture. SMA:T is an extension of the EHR system and uses Module Driven Software Development to generate standardized applications and interfaces. The Operational Data Model (ODM) was used as the standard. Standardized data was entered on iPads via the Mobile Patient Survey (MoPat) and the web application Mopat@home, the standardized transmission, processing, display and export of data was realized via SMA:T.ResultsThe technical feasibility was demonstrated in the course of the study. 19 standardized documentation forms with 241 items were created. In 317 patients, 6,451 instances were automatically transferred to the EHR system without errors. 96,323 instances were automatically transferred from the EHR system to the research database for further analyses.ConclusionsWith the present study, we present the successful implementation of the informatics infrastructure enabling standardized data acquisition, and data access for future real-time predictive modelling in clinical routine in psychiatry. The technical solution presented here might guide similar initiatives at other sites and thus help to pave the way towards future application of predictive models in psychiatric clinical routine.