Reliability of the minimum basic dataset for diagnoses of cerebrovascular disease. / Fiabilidad del conjunto mínimo básico de datos en el diagnóstico de la enfermedad cerebrovascular.

INTRODUCTION: The minimum basic dataset is the largest available hospital care administrative database that is used in clinical studies and hospital management in association with diagnosis-related groups (DRGs). In 2011, the quality of the national MBDS in hospital discharges was audited, in order to assess its reliability. This paper presents a sub-analysis of the results from that analysis which are referred to cerebrovascular disease (CVD). METHODS: Using all discharge reports from the Spanish MBDS in 2009, a representative sample was obtained by stratified sampling and 11 209 records were evaluated. Outcome indicators were obtained to measure any differences observed between the national MBDS being evaluated and the hospital's original MBDS. Analysis of codes for CVD as a primary diagnosis was performed for ICD-9-CM diagnostic categories 430 through 438. We evaluated error rates in the selection and classification of main diagnoses, as well as in DRG assignment. RESULTS: There were 397 discharges of cases of CVD which included 21 different DRGs. Diagnostic coding showed a concordance rate of 81.87%; the selection error rate was 2.26% and the classification error rate was 15.87%. The error rate in the DRG was 16.12% and associated with the greatest impact on the mortality risk level. CONCLUSIONS: While the errors we observed must be taken into account, data suggest that the quality of the MBDS for CVD is sufficient to ensure delivery of valid information. The hospital discharge registry serves as a valuable tool for use in studies of this disease.

Off-label intravenous thrombolysis in acute stroke.

BACKGROUND AND PURPOSE: Therapy for stroke with intravenous tissue plasminogen activator (IV-tPA) is hampered by tight licensing restrictions; some of them have been discussed in recent literature. We assessed the safety and effectiveness of off-label IV-tPA in the clinical settings. METHODS: Retrospective analysis of all the patients treated with IV-tPA at our Stroke Unit. Patients were divided into two groups by licence criteria [on-label group (OnLG), off-label group (OffLG)]. Primary outcome measures were symptomatic intracranial haemorrhages (sICH), major systemic haemorrhages, modified Rankin scale (mRS) and mortality rate at 3months. RESULTS: Five hundred and five patients were registered, 269 (53.2%) were assigned to OnLG and 236 (46.9%) to OffLG. Inclusion criteria for the OffLG were aged >80 years (129 patients), time from onset of symptoms to treatment over 3h (111), prior oral anticoagulant treatment with International Normalised Ratio≤1.7 (41), combination of previous stroke and diabetes mellitus (14), surgery or severe trauma within 3months of stroke (13), National Institutes of Health Stroke Scale score over 25 (11), intracranial tumours (5), systemic diseases with risk of bleeding (7) and seizure at the onset of stroke (2). No significant differences were identified between both groups regarding the proportion of sICH (OnLG 2.2% vs. OffLG 1.6%, P=0.78) or the 3-month mortality rate (11.1% vs. 19%: odds ratio (OR), 1.49; 95% CI, 0.86-2.55; P=0.14). Multivariate analysis showed no significant differences in functional independence at 3months between both groups (mRS <3 64.3% vs. 50.4%: OR mRS >2 1.7; 95% CI, 0.96-2.5; P=0.07). CONCLUSION: Intravenous thrombolysis may be safe and efficacious beyond its current label restrictions.