ALLERGIC OR HYPERSENSITIVITY Clinical Trial
Official title:
ANALYSIS OF HEALTH DATA COLLECTED SYSTEMATICALLY BY THREE HOSPITALS FOR THE VALIDATION OF THE CHAPTER "ALLERGY AND HYPERSENSITIVITY" IN THE FUTURE VERSION 11 OF THE WORLD HEALTH ORGANIZATION (WHO) INTERNATIONAL CLASSIFICATION OF DISEASES (CIM)
Allergic diseases, including allergic asthma, allergic rhinitis and anaphylaxis are not
properly classified in current classifications of diseases. We here propose a project based
on the evaluation of medical records of hospital databases of patients suffering for allergic
and hypersensitivity conditions coded with the current and a new coming version of the
international classification of diseases, no patient or intervention will be analysed.
We here propose a study to update and reach quality assurance of the classification of
allergic and hypersensitivity conditions in international classification systems. The
Allergic and hypersensitivity conditions section has indeed been recently built into the new
ICD-11 framework and we aim to reach its quality assurance by evaluating medical records of
French hospital databases. All the consecutive cases related to allergic and hypersensitivity
conditions registered in the last 1 year will be selected and blind-coded by two independent
coders based on the online English versions of the ICD-10 (2015 version) and ICD-11 Beta
draft. The generated data will support the intra and inter-variability testing, survey among
end-users and economic-impact evaluation. The economic impact of the transition from ICD-10
to ICD-11 will be analysed based on average estimated cost per day of each principal
diagnosis and the effect of the classification change will be quantified by the cost variance
of inter or intra diagnosis of ICD-10 and ICD-11. For the bridge procedure based on the
alignment of the allergic and hypersensitivity conditions described into the ICD-10 (and
ICD-10 CM US adaptation) framework to the ICD-11 beta phase, we propose the mapping and
cross-linking terms methods. Meanwhile, we will start updating the allergic and
hypersensitivity procedures by influencing the International Classification of Health
Intervention (ICHI).
Rationale for this Non-Interventional Study Allergic diseases, including allergic asthma,
allergic rhinitis and anaphylaxis are not properly classified in current classifications of
diseases. We here propose a project based on the evaluation of medical records of hospital
databases of patients suffering for allergic and hypersensitivity conditions coded with the
current and a new coming version of the international classification of diseases, no patient
or intervention will be analized.
Objectives of this Non-Interventional Study Main Objectives: To assess the stability of codes
for ICD-10 allergic diseases and hypersensitivity to ICD-11 using the medical-administrative
databases of 3 hospitals.
Secondary Objectives: (I) To adjust the terms and links for allergic diseases and
hypersensitivity and thus continue the on-line implementation process of ICD-11 based on the
lessons learned on the main objective; (II) To estimate the economic impact of ICD-10 and
ICD-11 transition for health care facilities; (III) To electronically align ICD-10 codes (and
CM adaptation in the USA) with ICD-11.
Study design All the consecutive cases of allergies over a year and registered in the DIM
bases of 3 healthcare establishments (the university hospital of Montpellier (CHRUM), Paris
(APHP), Toulouse) will be individualized. Depending on the size of the facility, ½ to 1/10 of
the cases will be included in the study. All cases will be selected anonymously. Two
professional coders will encode the selected cases twice. The analysis of the data will be
based on the degree of inter-encoder agreement using Cohen's Kappa coefficient. At the end of
this process, we will be able to identify the correspondence between the codes recorded in
the DIM database (ICD-10) and those of the new classification. In the event of discordant
results, consensus will be reached by involving other coding experts from CHRUM. The economic
impact of the transition from ICD-10 to ICD-11 will be approximated by estimating the average
costs per ICD code used in the main diagnosis.
Target subject population Our project is focused on allergic and hypersensitivity sufferers.
Although we intend to validate the classification of allergic and hypersensitivity
conditions, the international classification systems are for global use and our methodology
might be helpful for other diseases and for the program of medicalization and information
system (PMSI).
Statistical methods In order to reach the inter and intra-variability testing, the data
analysis will be based on the degree of inter-rater agreement using Cohen's Kappa.
The economic impact of the transition from ICD-10 to ICD-11 will be analized based on average
estimated cost per day of each principal diagnosis and the effect of the classification
change will be quantified by the cost variance of inter or intra diagnosis of ICD-10 and
ICD-11.
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