Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France

Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study

The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic neuralgia (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.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Other: Data collection

Detailed Description

• An observational, prospective cohort study of patients ≥ 50 years old with a Herpes Zoster (HZ) diagnosis, carried out by a national random sample of community first line practitioners concerned by HZ diagnosis: general practitioners, dermatologists and ophthalmologists.
• All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses 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.
• All Patients of the HZ cohort presenting a Post-herpetic neuralgia (PHN) 3 months after onset of the HZ rash onset will be included secondarily in the PHN cohort
• Patients of the HZ cohort will be followed-up for 3 months (i.e. 1 and 3 months after HZ rash onset) and patients of the PHN cohort will be followed-up for additional 6 months (i.e., 6 and 9 months after HZ rash onset) using phone interviews with a nurse.
• 250 cases of HZ and 40 cases of PHN are expected, with the hypothesis of 16% of PHN 3 months after HZ rash onset.

• Study Type: Observational
• Enrollment (Actual): 106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study has been designed to include 250 patients ≥ 50 years old with a first visit for diagnosis of HZ during a 6-month inclusion period (HZ cohort) and 40 expected cases of PHN after 3 months of HZ rash onset.

Description

Inclusion Criteria:

• For HZ cohort

  • Patient with a first visit for a diagnosis of HZ and who attend the clinic within two week of the HZ start of symptoms,
  • Without history of previous HZ,
  • ≥ 50 years old,
  • Who agree to participate and signed informed consent,
  • Able to understand the study, to complete self-administered questionnaires and to answer phone interviews.

• For PHN cohort

  • All Patients of the HZ cohort presenting PHN 3 months after onset of the HZ rash onset will be included in the PHN cohort. PHN will be defined as the presence of HZ-associated severe pains: ≥ 3 of the ZBPI item "worst pain".

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HZ cohort; All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and no earlier case of HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.	Other: Data collection; Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.	Evaluation of HZ and PHN related direct medical costs were done by the drugs prescribed before and at inclusion. The drugs prescribed were defined as a direct cost.	Before inclusion and at inclusion (Month 0)
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit	Evaluation of HZ and PHN related indirect costs, estimated by direct medical costs were done by the sick leave prescription and medical visit at inclusion. Sick leave prescriptions were defined as an indirect medical cost and medical visits were defined as a direct medical cost.	At Inclusion (Month 0)
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits	Evaluation of HZ and PHN related direct medical costs were done by drugs prescribed, sick leaves prescribed, medical visits to a specialist and patient reference to a hospital.	Cumulatively up to Month 3
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits	Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 3 to month 6 for the PHN cohort	From Month 3 to Month 6
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits	Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 6 to month 9 for the PHN cohort	From Month 6 to Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire	HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain. The Zoster Brief Pain Inventory (ZBPI) questionnaire is a self-administered form to assess HZ pain and burden associated with HZ pain using scales from: 0 for no pain to 10 for the most horrible pain that can be imagined,; 0 for no improvement to 100% for full improvement with painkiller,; 0 for no burden to 10 for full burden.	At inclusion (Month 0), Month 1 and Month 3
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire	HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.	At inclusion (Month 0), Month 1, 3, 6 and 9
Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie	Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single mean index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A mean of this health state was recorded for subjects analyzed in this outcome measure	At inclusion (Month 0)
Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort	Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A median of this health state was recorded for subjects analyzed in this outcome measure	At inclusion (Month 0), Month 1, 3, 6 and 9

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2016
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: France; Herpes zoster; Post-herpetic neuralgia; Economic burden of disease
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Virus Diseases; Infections; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Neuralgia; Herpes Zoster; Herpes Simplex; Neuralgia, Postherpetic
• Other Study ID Numbers: 201926