IMPACT OF ISABEL ON CLINICAL DECISION-MAKING IN ACUTE PAEDIATRICS SUMMARY OF RESULTS FROM A SIMULATED FIELD TRIAL TRIAL DESIGN Balanced, experimental design “Repeated measures” evaluation Paediatricians of various grades registered as ISABEL users, and final-year medical students from Imperial College Medical School, St Mary’s Campus, were invited to participate in a simulated trial which aimed to assess changes in clinical decision-making in acute paediatrics after provision of decision support in the form of the ISABEL system. 24 case histories that described the initial presenting features of children in an acute paediatric setting were chosen as cases for the trial. They were balanced in terms of level of difficulty (1 – uncommon to 3 – common) and speciality assignment (12 different paediatric specialities). A specially configured, password-protected trial website was created at www.isabel.org.uk/trial that automatically recorded decisions made by the subjects. Subjects were asked to make decisions regarding differential diagnosis, immediate investigation plan and management steps for a randomly chosen set of 12 cases first. In a second step, based on the diagnostic suggestions provided by ISABEL for each case, subjects were given the opportunity to modify any of their previous clinical decisions. It was not possible to proceed from the first step to the second unless the subject’s own decisions (without decision-support) were clearly recorded on the trial site. The main site at www.isabel.org.uk was barred for use for all trial users for the length of time they participated in the trial. Data collected other than the clinical decisions included time taken to process each page, length of each subject’s paediatric experience and previous use of ISABEL. Page 1 of 3 PRINCIPAL OUTCOME MEASURES 1. Quality scores for differential diagnosis, investigations and management steps 2. Number of clinically important diagnoses reminded by ISABEL 3. Time spent on each page 4. Number of decisions with negative clinical impact RESULTS Table 1: General data regarding trial participants Description Number Total number of participants Participants who completed all 12 cases Breakdown of subjects by grade 76 52 Consultants: 18 Registrars: 24 SHOs: 19 Medical students: 15 751 ([52 x 12 = 624] + 127) Total number of episodes of usage available Quality scores Table 2: Increase in quality scores Average pre-ISABEL (SD) Average post-ISABEL (SD) Differential diagnosis 37.9 (19.1) 42.7 (18.7)* Investigations 35 (19.5) 36.9 (19.7)* Management 17.33 (14.7) 18.23 (15)* * significant p value (paired t test) p<0.001 Clinically significant diagnoses In 77 episodes/751 total episodes, the user was prompted to consider the ‘correct’ diagnosis after consultation with ISABEL (10.25%). In an additional 2.4%, a ‘near-correct’ diagnosis was added by the user to the list after ISABEL decision support. In summary, in 12.7% cases, a clinically significant diagnosis was added by the user only after ISABEL consultation. Time In total, time data was complete in 633 episodes. Median time to process first step (pre-ISABEL): 6 min 2 sec (cons: 5 min 42 sec, students: 8 min 36 sec) Median time to process second step (post-ISABEL): 1 min (cons: 42 sec, students: 3 min 42 sec) Negative impact 7 tests scored negative score 26 steps scored negative score 70 significant tests 49 significant steps