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. 2018 Feb 8;13(Suppl 1):9.
doi: 10.1186/s13023-017-0750-x.

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

Nadine Pellen  1 , Laëtitia Guéganton  2 , Dominique Pougheon Bertrand  3 , Gilles Rault  4
Affiliations

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

Nadine Pellen et al. Orphanet J Rare Dis. .

Abstract

Background: The 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.

Methods: The 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.

Results: The 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.

Conclusions: This 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.

Keywords: Cystic fibrosis; Measurement recommendations; Quality audit; Registry.

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Conflict of interest statement

Ethics approval and consent to participate

Regulatory authorizations were granted for the quantitative research part focused on the patients’ personal health data: a favorable opinion from the Ethics Committee of the Brest University Hospital (CHU) (session on 13 May 2014) and a notification of authorization by CNIL for a change in data processing stipulating the addition of a new recipient of the Registry data within the framework of a care quality improvement program (DR2015040 on 16 February 2015).

Consent for publication

NA

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Location of the 14 CFCs involved in PHARE-M between 2011 and 2013
Fig. 2
Fig. 2
Discrepancies observed in the patient records
Fig. 3
Fig. 3
Discrepancies found in the PFT source files
See this image and copyright information in PMC

References

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    1. Notification of CNIL authorization issued in March 2007 turning the French National Cystic Fibrosis Observatory (ONM) into the French Cystic Fibrosis Registry (RFM). Available on demand. www.grosfichiers.com/IULk8gEIkly3v
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