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. 2019 Aug 19;3(6):857-864.
doi: 10.1002/bjs5.50209. eCollection 2019 Dec.

Data verification of nationwide clinical quality registries

Affiliations

Data verification of nationwide clinical quality registries

L R van der Werf et al. BJS Open. .

Abstract

Background: Clinical auditing is an emerging instrument for quality assessment and improvement. Moreover, clinical registries facilitate medical research as they provide 'real world' data. It is important that entered data are robust and reliable. The aim of this study was to describe the evolving procedure and results of data verification within the Dutch Institute for Clinical Auditing (DICA).

Methods: Data verification performed on several (disease-specific) clinical registries between 2013 and 2015 was evaluated. Sign-up, sample size and process of verification were described. For each procedure, hospitals were visited by external data managers to verify registered data. Outcomes of data verification were completeness and accuracy. An assessment of the quality of data was given per registry, for each participating hospital. Using descriptive statistics, analyses were performed for different sections within the individual registries.

Results: Seven of the 21 registries were verified, involving 174 visits to hospital departments. A step-by-step description of the data verification process was provided. Completeness of data in the registries varied from 97·2 to 99·4 per cent. Accuracy of data ranged from 88·2 to 100 per cent. Most discrepancies were observed for postoperative complications (0·7-7·5 per cent) and ASA classification (8·5-11·4 per cent). Data quality was assessed as 'sufficient' for 145 of the 174 hospital departments (83·3 per cent).

Conclusion: Data verification revealed that the data entered in the observed DICA registries were complete and accurate.

Antecedentes: La auditoría clínica es un instrumento emergente para la evaluación y mejora de la calidad. Además, los registros clínicos facilitan la investigación médica ya que proporcionan datos de la “vida real”. Es importante que los datos introducidos sean completos y fiables. El objetivo de este estudio fue describir la evolución y los resultados del procedimiento de verificación de datos en el seno del Instituto Holandés de Auditorias Clínicas (Dutch Institute for Clinical Auditing, DICA).

Métodos: Se evaluó la verificación de datos realizada en varios registros clínicos (específicos de enfermedad) entre 2013‐2015. Se describió el sistema de registro, tamaño de la muestra y el proceso de verificación. Para cada procedimiento, los hospitales fueron visitados por administradores de datos externos para verificar los datos registrados. Los resultados de la verificación de datos fueron la integridad y la exactitud. Se proporcionó una evaluación de la calidad de los datos para cada registro en cada uno de los hospitales que participaron. Mediante la utilización de estadística descriptiva, se realizaron análisis de diferentes secciones para cada uno de los registros.

Resultados: Siete de los 21 registros fueron verificados, lo que implicó un total 174 visitas a los departamentos de los hospitales. Se proporcionó una descripción paso a paso del proceso de verificación de los datos. La integridad de los datos en los registros varió entre 97,3‐99,4%. La exactitud de los datos varió entre 86,6‐97,0%. La mayoría de las discrepancias se observaron en las complicaciones postoperatorias (0,7‐7,5%) y clasificación ASA (7,5‐11%). La calidad de los datos se consideró “suficiente” en 145 de 174 (83%) departamentos hospitalarios.

Conclusión: La verificación de los datos reveló que la introducción de datos en los registros DICA analizados era bastante completa y exacta.

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