Can Real-World Data From Hospital Information Systems Be Directly Utilized for Efficacy Studies: An Analysis of Data Time Points.

Background: Data from Hospital Information Systems are crucial components of real-world data, but concerns arise regarding the transparency of measurement time-points when directly utilizing for efficacy studies. The objective of the study was to analyze the distribution characteristics of time-points for laboratory test records from HIS.

Method: Medical records before December 31, 2019 from Affiliated Hospital of Shandong University of Traditional Chinese Medicine, for patients primarily diagnosed with coronary heart disease (CHD), or heart failure combined with secondary diagnosis of CHD were retrieved from HIS. Fifteen test groups were extracted. The number of records, average of test times, and distribution characteristics of time points were analyzed.

Results: The renal function tests have the most records, and the blood glucose have the most times. Tests time-points distribution showed concentration in the early stage of hospitalization, with the majority occurring within the first 0-10%. For those measured ≥2 times, their first tests are also centrally distributed in the early stage, while the lasts in all period of hospitalization. Besides, substantial difference is showed in the time span of the first and last test. Abnormal value may be a trigger that promotes more intensive examination, and normal or abnormal status of the first examination is significantly weak to moderate correlated with the number of examinations and time span.

Discussion: The disclosure of time-points of clinical studies based on HIS should be encouraged and the pre-survey of data measuring time point is essential to the design of trial.