Postmarketing Surveillance Based on Electronic Patient Records: The IPCI Project

1999 ◽  
Vol 38 (04/05) ◽  
pp. 339-344 ◽  
Author(s):  
J. van der Lei ◽  
B. M. Th. Mosseveld ◽  
M. A. M. van Wijk ◽  
P. D. van der Linden ◽  
M. C. J. M. Sturkenboom ◽  
...  

AbstractResearchers claim that data in electronic patient records can be used for a variety of purposes including individual patient care, management, and resource planning for scientific research. Our objective in the project Integrated Primary Care Information (IPCI) was to assess whether the electronic patient records of Dutch general practitioners contain sufficient data to perform studies in the area of postmarketing surveillance studies. We determined the data requirements for postmarketing surveil-lance studies, implemented additional software in the electronic patient records of the general practitioner, developed an organization to monitor the use of data, and performed validation studies to test the quality of the data. Analysis of the data requirements showed that additional software had to be installed to collect data that is not recorded in routine practice. To avoid having to obtain informed consent from each enrolled patient, we developed IPCI as a semianonymous system: both patients and participating general practitioners are anonymous for the researchers. Under specific circumstances, the researcher can contact indirectly (through a trusted third party) the physician that made the data available. Only the treating general practitioner is able to decode the identity of his patients. A Board of Supervisors predominantly consisting of participating general practitioners monitors the use of data. Validation studies show the data can be used for postmarketing surveillance. With additional software to collect data not normally recorded in routine practice, data from electronic patient record of general practitioners can be used for postmarketing surveillance.

1999 ◽  
Vol 38 (04/05) ◽  
pp. 287-288 ◽  
Author(s):  
J. van der Lei ◽  
P. W. Moorman ◽  
M. A. Musen

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marina Beckmann ◽  
Kerstin Dittmer ◽  
Julia Jaschke ◽  
Ute Karbach ◽  
Juliane Köberlein-Neu ◽  
...  

Abstract Background The need for and usage of electronic patient records within hospitals has steadily increased over the last decade for economic reasons as well as the proceeding digitalization. While there are numerous benefits from this system, the potential risks of using electronic patient records for hospitals, patients and healthcare professionals must also be discussed. There is a lack in research, particularly regarding effects on healthcare professionals and their daily work in health services. The study eCoCo aims to gain insight into changes in interprofessional collaboration and clinical workflows resulting from introducing electronic patient records. Methods eCoCo is a multi-center case study integrating mixed methods from qualitative and quantitative social research. The case studies include three hospitals that undergo the process of introducing electronic patient records. Data are collected before and after the introduction of electronic patient records using participant observation, interviews, focus groups, time measurement, patient and employee questionnaires and a questionnaire to measure the level of digitalization. Furthermore, documents (patient records) as well as structural and administrative data are gathered. To analyze the interprofessional collaboration qualitative network analyses, reconstructive-hermeneutic analyses and document analyses are conducted. The workflow analyses, patient and employee assessment analyses and classification within the clinical adoption meta-model are conducted to provide insights into clinical workflows. Discussion This study will be the first to investigate the effects of introducing electronic patient records on interprofessional collaboration and clinical workflows from the perspective of healthcare professionals. Thereby, it will consider patients’ safety, legal and ethical concerns and quality of care. The results will help to understand the organization and thereby improve the performance of health services working with electronic patient records. Trial registration The study was registered at the German clinical trials register (DRKS00023343, Pre-Results) on November 17, 2020.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sophie Relph ◽  
◽  
Maria Elstad ◽  
Bolaji Coker ◽  
Matias C. Vieira ◽  
...  

Abstract Background The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript was to outline the data collection and management considerations of a maternity and perinatal clinical trial using data from electronic patient records, exemplifying the DESiGN Trial as a case study. Methods The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses. Data on maternal/perinatal characteristics and outcomes including infants admitted to neonatal care, parameters from foetal ultrasound and details of hospital activity for health-economic evaluation were collected at two time points from four types of electronic patient records held in 22 different electronic record systems at the 13 research clusters. Data were pseudonymised on site using a bespoke Microsoft Excel macro and securely transferred to the central data store. Data quality checks were undertaken. Rules for data harmonisation of the raw data were developed and a data dictionary produced, along with rules and assumptions for data linkage of the datasets. The dictionary included descriptions of the rationale and assumptions for data harmonisation and quality checks. Results Data were collected on 182,052 babies from 178,350 pregnancies in 165,397 unique women. Data availability and completeness varied across research sites; each of eight variables which were key to calculation of the primary outcome were completely missing in median 3 (range 1–4) clusters at the time of the first data download. This improved by the second data download following clarification of instructions to the research sites (each of the eight key variables were completely missing in median 1 (range 0–1) cluster at the second time point). Common data management challenges were harmonising a single variable from multiple sources and categorising free-text data, solutions were developed for this trial. Conclusions Conduct of clinical trials which use electronic patient records for the assessment of outcomes can be time and cost-effective but still requires appropriate time and resources to maximise data quality. A difficulty for pregnancy and perinatal research in the UK is the wide variety of different systems used to collect patient data across maternity units. In this manuscript, we describe how we managed this and provide a detailed data dictionary covering the harmonisation of variable names and values that will be helpful for other researchers working with these data. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered on 02/11/16.


2012 ◽  
Vol 30 (2) ◽  
pp. 227-232 ◽  
Author(s):  
F. Stevenson ◽  
N. Lloyd ◽  
L. Harrington ◽  
P. Wallace

2019 ◽  
Vol 22 (4) ◽  
pp. 478-483 ◽  
Author(s):  
Melinda Craike ◽  
Helena Britt ◽  
Alexandra Parker ◽  
Christopher Harrison

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Peter P. Groenewegen ◽  
Stefan Greß ◽  
Willemijn Schäfer

Background. The participation of general practitioners (GPs) is essential in research on the performance of primary care. This paper describes the implementation of a large, multicountry study in primary care that combines a survey among GPs and a linked survey among patients that visited their practice (the QUALICOPC study). The aim is to describe the recruitment procedure and explore differences between countries in the participation rate of the GPs. Methods. Descriptive analyses were used to document recruitment procedures and to assess hypotheses potentially explaining variation in participation rates between countries. Results. The survey was implemented in 31 European countries. GPs were mainly selected through random sampling. The actual implementation of the study differed between countries. The median participation rate was 30%. Both material (such as the payment system of GPs in a country) and immaterial influences (such as estimated survey pressure) are related to differences between countries. Conclusion. This study shows that the participation of GPs may indeed be influenced by the context of the country. The implementation of complex data collection is difficult to realize in a completely uniform way. Procedures have to be tuned to the context of the country.


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