Lessons from the on-site quality audit of data transmitted to the French cystic fibrosis registry

Abstract

BackgroundThe French Cystic Fibrosis Registry takes a census of the population of patients and records their annual data transmitted by Cystic Fibrosis Centers (CFCs). Quality of patient data has been a focus in the past years, with the implementation of automated controls before data integration. The objective was to assess, at the 14 CFCs trained in the quality improvement named Hospital Program to Improve Outcomes and Expertise in Cystic Fibrosis (PHARE-M), the quality of the 2012 and 2013 data transmitted to the French Registry with respect to the rules established to obtain forced expiratory volume in 1 second (FEV1%) and anthropometric data.MethodsThe clinical researcher selected 20 patients at each CFC from age ranges corresponding to different visit frequencies and measurement procedures in order to reach saturation of error causes. The control consisted in comparing source data, pulmonary function tests (PFTs), patient records, and data in the Registry.ResultsThe audit focused on 242 patients, 2455 consultations and 1855 PFTs. Less than 5% of data concerning weight, height, or FEV1 (L) in the patient records files had discrepancies with source data. Discrepancies on patient height between patient records and PFT files were found in 11% of cases. For one hundred and ten patients (45%), anomalies were found between the patient record and the Registry for the FEV1% and the associated anthropometric measurements mainly related to the interpretation of the selection rule of the venue corresponding to the “best spirometry in the year” and the reference standard used (local standards versus Knudson reference equations). For the 33 children in the age range of 6–17 years old (27% out of 120 children records controlled), the FEV1% value in the Registry presented an average deviation of +4.25% (min. = −9.3%; max. = +16.9%; median = 4%) with the value from the Patient record.ConclusionsThis first on-site quality audit of the data transmitted to the Registry pointed out variability in the measurement process at the CFCs. The rule for selecting the data for the Registry was applied differently at some CFCs, and various local References for the FEV1% calculation were used. Avenues for improvement have been identified.

Data accuracy, consistency and completeness of the national Swiss cystic fibrosis patient registry: Lessons from an ECFSPR data quality project

“…Few studies have assessed data quality in CF registries, and difficulties in correctly applying variable definitions have been in the focus ever since. An early French study compared clinical source data to registry data in 242 records collected from different CF centers and, similar to our findings, observed a high discrepancy especially for FEV1 data and the associated anthropometric measures as a result of wrongly selected lung function measurements [12]. This study also found considerable deviation of lung function values by incorrect application of spirometry reference standardsa problem the ECFSPR has overcome by collection of lung volumes in liters only and computing predicted values by a standardized reference internally within the ECFSTracker software, applying the Global Lung Function Initiative equations [13].…”

“…A complete overview of all interventions to improve data quality in large, rare disease registries is depicted in Table 4. The determination of interventions and identification of their anticipated impact stated here were identified by the experience from the ECFSPR and Swiss national data quality audits, but also include suggestions from other reports on data quality in registries [3,4,7,8,12].…”

Acute respiratory failure due to pulmonary exacerbation in children with cystic fibrosis admitted in a pediatric intensive care unit: outcomes and factors associated with mortality

“…Those admitted after July 2007 benefited from the implementation of the HELT system that prioritizes graft allocation to patients with short-term severe prognoses. This new organ allocation system was not associated with higher post-transplant mortality in adults, with a survival rate at 12 months around 80% [ 36 , 37 ]. Twelve children of our cohort were transplanted within the frame of HELT and their survival at 12 months was comparable to that of adults.…”

Quality of anthropometric data measured in children and adolescents with cystic fibrosis: a scoping review

“…Studies carried out using medical record-based data may not be reliable due to failures in recording of the data, different approaches used to obtain measurements, or missing data from the medical records. 46 The same criticism may be applied to studies based on patient registries, since these may include the additional bias of methodological heterogeneity in measurements collected by different institutions. This possible source of error can be reduced by adopting standard criteria for datum measurement 47 and quality control during the collection of data.…”