FEASIBILITY OF USE OF MEDICAL TRANSCRIPTION DATA FOR REAL WORLD EVIDENCE GENERATION IN THE UNITED STATES (US)- A PILOT STUDY OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) INITIATED ON BELIMUMAB
Author(s)
Narayanan S* Ipsos Healthcare, Gaithersburg, MD, USA
Presentation Documents
OBJECTIVES: To assess the feasibility of use of medical-transcription data for real-world clinical evidence generation in the US. METHODS: Majority of clinical practices in the US are experimenting digitization of patient medical records for two reasons: patient-management/care-delivery and billing/administrative/legal documentation purposes. Increasingly, physicians are using medical-transcription services, where physicians dictate details of patient visits and send the voice-recording-device to medical-transcription organization which processes voice-data and delivers electronic-files back to clinics; physicians review/revise/append the electronic-documentation and adds data to their patient-database-repository for future use. This pilot study assessed the utility of de-identified medical-transcription data in evaluating patient-physician dynamics and real-world treatment patterns/outcomes and documented adverse-events(AEs) using random set of adult SLE patients who initiated belimumab (a recently-launched biologic) within the past 2years as part of usual care. SLE was chosen specifically because of its complex clinical management issues. RESULTS: Nineteen belimumab patient transcription-records (de-identified) were reviewed (mean age:39.4yrs; female:95%). Top-4 clinical-manifestations at belimumab-start were: musculoskeletal(68%)/mucocutaneous(53%)/constitutional(42%)/renal(21%). Physicians discussed belimumab-attributes (specifically, infection-risks/AEs/etc), asked patients to do their own research on belimumab, and cited insurance/reimbursement-issues prior to belimumab-start in 58%, 26% & 26% of cases respectively; 11% of patients asked for belimumab. Top-3 documented-reasons for belimumab-start were: steroid-sparing(32%), control autoimmune diathesis(11%), control SLE-flares(16%). In 47% of patients, belimumab (at initiation) replaced another medication (majority:steroids/immunosuppressants); concomitant SLE-medications were: antimalarials(84%)/oral-steroids(68%)/Immunosuppressants(47%). Average belimumab-duration was 8.1months (overall data availability/patient:23.8months). During the observation period, 42% had >=1AE (e.g., diarrhea/rash/bronchiolitis/alopecia/upper-respiratory-track-infection), 42% discontinued belimumab (but 26% re-started) and 47% had some physician-documented improvement in outcomes (e.g., joint-pain/rash/energy level/fatigue). One patient had documented steroid-stoppage post-belimumab initiation. CONCLUSIONS: Medical-transcription data may provide documented real-world evidence of treatment dynamics and clinical status/outcomes associated with patient care. In this random cohort of SLE patients using belimumab, belimumab appears to provide some demonstrable benefits in almost half of the patients.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PRM52
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Systemic Disorders/Conditions