POSTHER - Burden of herpes zoster and postherpetic neuralgia among people ≥ 50 years old in France
Head :
ROUSTAND Laetitia, GSK
Last update : 09/07/2020 | Version : 3 | ID : 73317
| General | |
| Identification | |
| Detailed name | Burden of herpes zoster and postherpetic neuralgia among people ≥ 50 years old in France |
| Sign or acronym | POSTHER |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 915162 |
| General Aspects | |
| Medical area |
Dermatology, venereology Neurology |
| Pathology (details) | Zona |
| Health determinants |
Others (specify) |
| Others (details) | viral infection |
| Keywords | zona, varicella zoster virus, VHZ, vaccination |
| Scientific investigator(s) (Contact) | |
| Name of the director | ROUSTAND |
| Surname | Laetitia |
| Address |
Laboratoire GSK 100 route de Versailles 78163 MARLY LE ROI CEDEX |
| laetitia.m.roustand@gsk.com | |
| Unit | GSK |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Details | Paid by the Sponsor |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | GlaxoSmithKline |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
An observational, prospective cohort study of patients ≥ 50 years old with a HZ diagnosis, carried out by a national random sample of community first line practitioners concerned by HZ diagnosis: general practitioners (GPs), dermatologists and ophthalmologists.
Inclusion • HZ cohort: All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnosis and without history of previous HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved (competitive inclusion), • PHN cohort: All patients of the HZ cohort presenting PHN (defined as ZBPI pain 3) 3 months after HZ rash onset symptoms will be included secondarily in the PHN cohort |
| Database objective | |
| Main objective |
Research question: To assess the burden of HZ and PHN among people ≥ 50 years old in France, in terms of healthcare resources used, medical direct and indirect costs, as well as pain severity and impact on quality of life.
Primary objective • To evaluate HZ-related and PHN-related direct medical costs and indirect costs during a 9-month period (overall, by gender and age-classes). Secondary objectives • To describe HZ and PHN pain severity during a 9-month period (overall, by gender and age-classes), • To evaluate impact of HZ and PHN on the quality of life of patients during a 9-month period (overall, by gender and age-classes). |
| Inclusion criteria |
Study carried out by a random sample of community first line practitioners concerned by HZ diagnosis: GPs, dermatologists and ophthalmologists.
HZ cohort inclusion-exclusion criteria • Patient with a first visit for a diagnosis of HZ and who attend the clinic within two week of the HZ start of symptoms (defined as unilateral pain accompanied by a unilateral rash without alternative diagnosis), • Patient ≥ 50 years old without history of previous HZ, • Patient who agree to participate and signed informed consent, • Patient able to understand the study, to complete self-administered questionnaires (alone or with the help of a relative) and to answer to phone interviews. PHN cohort inclusion-exclusion criterion • Patient of the HZ cohort presenting PHN 3 months after onset of the HZ rash onset (defined as the presence of HZ-associated severe “worst” pain: pain ≥ 3 from ZBPI item “worst pain”) |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | B02 - Zoster [herpes zoster] |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2016 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | • 250 cases of HZ and 40 cases of PHN expected |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data Cost data Utility / preference data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Quality of life/perceived health (detail) | ZBPI and EQ5D questionnaires |
| Procedures | |
| Data collection method | phone to phone interview, paper self questionnaire |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | follow up by letters, email, phone |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | to be determined |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
