AzTrials
AzTrials

ALLERGIC OR HYPERSENSITIVITYAHCIM11NCT03213808

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

An observational study of ALLERGIC OR HYPERSENSITIVITY, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
ALLERGIC OR HYPERSENSITIVITY
How many people
100 participants
Where
1 siteFrance
Study dates
10 Jul 2017to 1 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pascal DEMLY, MD, PhD contact

467336118 ext. 33

p-demoly@inserm.fr

France1 site, 1 recruiting
  • Uhmontpellier

    Montpellier, 34295

    PASCAL DEMOLY, MD, phD, 467336118 ext. 33, p-demoly@inserm.fr

    Recruiting

Other trials in France

About this study

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).

Read the 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.

Being tested
No intervention: analysis of health data from patients with
Keywords
Allergic diseases, hypersensitivity, International Classification of Diseases (ICD), World Health Organization (WHO)
Medical subject headings
Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention: analysis of health data from patients withOther

    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

Study groups in NCT03213808
Study groupRoleWhat they receive
respiratory allergiesrespiratory allergies (asthma, rhinitis)
Receives: Other: No intervention: analysis of health data from patients with
skin allergiesskin allergies (dermatitis, urticarial, angioedema)
Receives: Other: No intervention: analysis of health data from patients with
anaphylaxisanaphylaxis
Receives: Other: No intervention: analysis of health data from patients with
gastrointestinal allergic conditionsgastrointestinal allergic conditions
Receives: Other: No intervention: analysis of health data from patients with
ocular allergiesocular allergies (conjunctivitis)
Receives: Other: No intervention: analysis of health data from patients with

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intra and inter-variability measures among coders and accuracy rate calculation

    Ease of use, level of ambiguity on a 0-4 scale

    Measured: 1 day

Secondary outcomes (1)
  1. International Classification of Diseases -10, -10CM and -11 term alignement

    International Classification of Diseases -10, -10CM and -11 term alignement

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study start10 Jul 2017
  3. Primary completion1 Sep 2018 (estimated)
  4. Study completion1 Sep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03213808
Sponsor's protocol ID
UF9863
Acronym
AHCIM11
Status last verified
Jul 2017
First submitted
7 Jul 2017
Last updated
3 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

An observational study of ALLERGIC OR HYPERSENSITIVITY, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pascal DEMLY, MD, PhD (467336118 ext. 33, p-demoly@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra and inter-variability measures among coders and accuracy rate calculation (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in