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.
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.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
PASCAL DEMOLY, MD, phD, 467336118 ext. 33, p-demoly@inserm.fr
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.
- Conditions
- ALLERGIC OR HYPERSENSITIVITY
- 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 group | Role | What they receive |
|---|---|---|
| respiratory allergies | respiratory allergies (asthma, rhinitis) Receives: Other: No intervention: analysis of health data from patients with | |
| skin allergies | skin allergies (dermatitis, urticarial, angioedema) Receives: Other: No intervention: analysis of health data from patients with | |
| anaphylaxis | anaphylaxis Receives: Other: No intervention: analysis of health data from patients with | |
| gastrointestinal allergic conditions | gastrointestinal allergic conditions Receives: Other: No intervention: analysis of health data from patients with | |
| ocular allergies | ocular 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.
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)
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.
- First posted11 Jul 2017
- Study start10 Jul 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLERGIC OR HYPERSENSITIVITYStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03213808
- Acronym / sponsor ID
- AHCIM11 / UF9863
- Conditions
- ALLERGIC OR HYPERSENSITIVITY
- Keywords
- Allergic diseases, hypersensitivity, International Classification of Diseases (ICD), World Health Organization (WHO)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| respiratory allergies | – | Other: No intervention: analysis of health data from patients withrespiratory allergies (asthma, rhinitis) |
| skin allergies | – | Other: No intervention: analysis of health data from patients withskin allergies (dermatitis, urticarial, angioedema) |
| anaphylaxis | – | Other: No intervention: analysis of health data from patients withanaphylaxis |
| gastrointestinal allergic conditions | – | Other: No intervention: analysis of health data from patients withgastrointestinal allergic conditions |
| ocular allergies | – | Other: No intervention: analysis of health data from patients withocular allergies (conjunctivitis) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- We will exclude from the study all cases in which the ICD-10 codes are not related to allergic and hypersensitivity conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention: analysis of health data from patients withNo 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 | Other | anaphylaxis, gastrointestinal allergic conditions, ocular allergies, respiratory allergies, skin allergies |
Primary outcome
Intra and inter-variability measures among coders and accuracy rate calculation
Time frame: 1 day
Ease of use, level of ambiguity on a 0-4 scale
1 secondary outcome
International Classification of Diseases -10, -10CM and -11 term alignement
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: Undecided. NC
Related trials for ALLERGIC OR HYPERSENSITIVITY
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.