Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data on the incidence, complications and impact on quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This study will also collect data on costs related to the HZ disease, especially postherpetic neuralgia (PHN)

Official Title
-----------------
Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

Conditions
-----------------
Herpes Zoster

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female >=50 years of age at the time of study enrolment presenting with acute HZ; HZ diagnosis for this HZ episode; is the subject's first outpatient diagnosis; OR took place at another site/ centre up to seven days before the initial visit for the present study; Ability to comply with study procedures*; Written informed consent obtained from the subject*. Note: * will be applicable to secondary objectives only and not for the primary objective to calculate incidence. Exclusion Criteria: • Subject participating in another research study. Note: This exclusion criteria is applicable to secondary objectives only and not for the primary objectives to calculate incidence.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Subjects presenting with HZ episode. | Other: Data collection<br>* HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender. |  | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of PHN, i.e. persistence of HZ-related pain. |  | 90, 180, and 270 days after onset of HZ. | 
| Anamnestic information, clinical parameters and complications related to HZ. |  | Between Day 0 and Day 270 | 
| Direct medical, direct non-medical and indirect costs related to HZ. |  | Between Day 0 and Day 90 | 
| Pain assessment in HZ subjects. |  | At Day 90 | 
| Quality of life assessment in HZ subjects |  | Day 15, Day 30, Day 60 and Day 90 | 
| Direct medical, direct non-medical and indirect costs related to PHN. |  | At Day 90, Day 180 and Day 270 | 
| Pain assessment in PHN subjects. |  | At Day 90, Day 180 and Day 270 | 
| Quality of life assessment in PHN subjects. |  | At Day 90, Day 180 and Day 270 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spain, cost, complications, incidence, adults, quality of life, Herpes Zoster, Surveillance