Routine hospital data - is it good enough for trials? An example using England's Hospital Episode Statistics in the SHIFT trial of Family Therapy vs. Treatment as Usual in adolescents following self-harm.

BACKGROUND: Use of routine data sources within clinical research is increasing and is endorsed by the National Institute for Health Research to increase trial efficiencies; however there is limited evidence for its use in clinical trials, especially in relation to self-harm. One source of routine data, Hospital Episode Statistics, is collated and distributed by NHS Digital and contains details of admissions, outpatient, and Accident and Emergency attendances provided periodically by English National Health Service hospitals. We explored the reliability and accuracy of Hospital Episode Statistics, compared to data collected directly from hospital records, to assess whether it would provide complete, accurate, and reliable means of acquiring hospital attendances for self-harm - the primary outcome for the SHIFT (Self-Harm Intervention: Family Therapy) trial evaluating Family Therapy for adolescents following self-harm.

METHODS: Participant identifiers were linked to Hospital Episode Statistics Accident and Emergency, and Admissions data, and episodes combined to describe participants' complete hospital attendance. Attendance data were initially compared to data previously gathered by trial researchers from pre-identified hospitals. Final comparison was conducted of subsequent attendances collected through Hospital Episode Statistics and researcher follow-up. Consideration was given to linkage rates; number and proportion of attendances retrieved; reliability of Accident and Emergency, and Admissions data; percentage of self-harm episodes recorded and coded appropriately; and percentage of required data items retrieved.

RESULTS: Participants were first linked to Hospital Episode Statistics with an acceptable match rate of 95%, identifying a total of 341 complete hospital attendances, compared to 139 reported by the researchers at the time. More than double the proportion of Hospital Episode Statistics Accident and Emergency episodes could not be classified in relation to self-harm (75%) compared to 34.9% of admitted episodes, and of overall attendances, 18% were classified as self-harm related and 20% not related, while ambiguity or insufficient information meant 62% were unclassified. Of 39 self-harm-related attendances reported by the researchers, Hospital Episode Statistics identified 24 (62%) as self-harm related while 15 (38%) were unclassified. Based on final data received, 1490 complete hospital attendances were identified and comparison to researcher follow-up found Hospital Episode Statistics underestimated the number of self-harm attendances by 37.2% (95% confidence interval 32.6%-41.9%).

CONCLUSION: Advantages of routine data collection via NHS Digital included the acquisition of more comprehensive and timely trial outcome data, identifying more than double the number of hospital attendances than researchers. Disadvantages included ambiguity in the classification of self-harm relatedness. Our resulting primary outcome data collection strategy used routine data to identify hospital attendances supplemented by targeted researcher data collection for attendances requiring further self-harm classification.