VALIDATION OF THE CHAPTER "ALLERGIES AND HYPERSENSITIVITY" OF THE INTERNATIONAL DISEASE CLASSIFICATION (CIM) (AHCIM11)

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).

Study Overview

• Status: Unknown
• Conditions: ALLERGIC OR HYPERSENSITIVITY
• Intervention / Treatment: Other: No intervention: analysis of health data from patients with

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Pascal DEMLY, MD, PhD; Phone Number: 33 467336118; Email: p-demoly@inserm.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: PASCAL DEMOLY, MD, phD; Phone Number: 33 467336118; Email: p-demoly@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ALLERGIC OR HYPERSENSITIVITY CONDITIONS: respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis)

Description

Inclusion Criteria:

Inclusion criteria:

- We here propose a study based on hospital database medical records. The cases will be selected based on pre-established (ICD-10) allergy corresponding codes: respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis).

The prescription of the medicinal product is clearly separated from the decision to include the subject in the non-interventional study

Exclusion criteria:

- We will exclude from the study all cases in which the ICD-10 codes are not related to allergic and hypersensitivity conditions.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
respiratory allergies; respiratory allergies (asthma, rhinitis)	Other: No intervention: analysis of health data from patients with; No intervention: analysis of health data from patients with respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis) for the validation of the chapter allergies and hypersensitivity in the future version of the WHO CIM
skin allergies; skin allergies (dermatitis, urticarial, angioedema)	Other: No intervention: analysis of health data from patients with; No intervention: analysis of health data from patients with respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis) for the validation of the chapter allergies and hypersensitivity in the future version of the WHO CIM
anaphylaxis	Other: No intervention: analysis of health data from patients with; No intervention: analysis of health data from patients with respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis) for the validation of the chapter allergies and hypersensitivity in the future version of the WHO CIM
gastrointestinal allergic conditions	Other: No intervention: analysis of health data from patients with; No intervention: analysis of health data from patients with respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis) for the validation of the chapter allergies and hypersensitivity in the future version of the WHO CIM
ocular allergies; ocular allergies (conjunctivitis)	Other: No intervention: analysis of health data from patients with; No intervention: analysis of health data from patients with respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis) for the validation of the chapter allergies and hypersensitivity in the future version of the WHO CIM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra and inter-variability measures among coders and accuracy rate calculation	Ease of use, level of ambiguity on a 0-4 scale	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Classification of Diseases -10, -10CM and -11 term alignement	International Classification of Diseases -10, -10CM and -11 term alignement	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion of allergy procedures in the International Classification of Health Interventions (ICHI)	Insertion of allergy procedures in the International Classification of Health Interventions (ICHI)	1 day
Health economics related the transition from the ICD-10 to ICD-11: cost variance of inter or intra diagnosis of ICD-10 and ICD-11	Health economics related the transition from the ICD-10 to ICD-11: cost variance of inter or intra diagnosis of ICD-10 and ICD-11	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: hypersensitivity; Allergic diseases; International Classification of Diseases (ICD); World Health Organization (WHO)
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: UF9863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No