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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02487472
Enrollment
106
Registered
2015-07-01
Start date
2016-01-19
Completion date
2017-08-28
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Keywords

France, Post-herpetic neuralgia, Herpes zoster, Economic burden of disease

Brief summary

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.

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.

Interventions

OTHERData collection

Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Before inclusion and at inclusion (Month 0)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.
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitAt Inclusion (Month 0)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.
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsCumulatively up to Month 3Evaluation 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.

Secondary

MeasureTime frameDescription
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireAt inclusion (Month 0), Month 1 and Month 3HZ 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.
Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L QuestionnarieAt inclusion (Month 0)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
Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortAt inclusion (Month 0), Month 1, 3, 6 and 9Impact 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

Participant flow

Recruitment details

Inclusion timeframe for the study was initially planned for 6 months. Due to the low rate of inclusion, this timeframe was extended from 6 to 13.5 months. A total of 106 subjects from the Herpes Zoster (HZ) cohort were included in this study.

Pre-assignment details

Out of 106 subjects included,5 subjects were excluded due to the following reasons:\<50 years,previous history of HZ ,not the first visit,consulted physician more than 2 weeks after start of HZ symptoms. A total of 101 subjects were included for analysis.Out of the 101 subjects,90 subjects completed the study.

Participants by arm

ArmCount
HZ Cohort
All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
101
Total101

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDid not complete telephonic interviews9
Overall StudyOther2

Baseline characteristics

CharacteristicHZ Cohort
Age, Continuous68.1 Years
STANDARD_DEVIATION 10.3
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
56 Participants
Sex: Female, Male
Male
45 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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.

Time frame: Before inclusion and at inclusion (Month 0)

Population: The analysis was performed on subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Antalgic-antipyretic, before inclusion10 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.NSAIDs, before inclusion3 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Systemic direct acting antiviral, before inclusion4 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Direct acting antiviral, at inclusion89 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Direct acting antiviral- systemic, at inclusion89 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Local cutaneous, at inclusion11 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Direct acting antiviral-Local ophthalmic-inclusion1 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.At least one Antalgic53 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Antalgic Level I27 Participants
HZ CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Antalgic Level II24 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.At least one Antalgic6 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Antalgic-antipyretic, before inclusion1 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Local cutaneous, at inclusion2 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.NSAIDs, before inclusion0 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Antalgic Level II3 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Systemic direct acting antiviral, before inclusion1 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Direct acting antiviral-Local ophthalmic-inclusion0 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Direct acting antiviral, at inclusion6 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Antalgic Level I3 Participants
PHN CohortEvaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.Direct acting antiviral- systemic, at inclusion6 Participants
Primary

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

Time frame: From Month 3 to Month 6

Population: Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria \& on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months \& followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, direct acting antiviral,Systemic0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, direct acting antiviral,Local0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level I1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level II0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsSick leave prescription0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Visits3 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, General practitioner0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Dermatologist0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Ophthalmologist0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Magnetizer0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Acupuncturist0 Participants
Primary

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.

Time frame: Cumulatively up to Month 3

Population: The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level II20 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Systemic80 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Magnetizer20 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsSick leave prescription5 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Acupuncturist3 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level I34 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Healer2 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, General practitioner89 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Osteopath1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Local12 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Radiologist1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Dermatologist6 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Rheumatologist1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Ophthalmologist2 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Rheumatologist0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Systemic4 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Local2 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level I6 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level II3 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsSick leave prescription1 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, General practitioner6 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Dermatologist0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Ophthalmologist0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Magnetizer3 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Acupuncturist0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Healer0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Osteopath0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visit, Radiologist0 Participants
Primary

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

Time frame: From Month 6 to Month 9

Population: Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria \& on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months \& followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsSick leave prescription1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Magnetizer0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, direct acting antiviral,Systemic0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, direct acting antiviral,Local0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level I0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsDrugs prescribed, Antalgic Level II0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Visits0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, General practitioner0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Dermatologist0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Ophthalmologist0 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical VisitsMedical visits, Acupuncturist0 Participants
Primary

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.

Time frame: At Inclusion (Month 0)

Population: The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitSick leave prescription3 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Dermatologist3 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Patient referred to a specialist9 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Angiologist1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Patient referred to the hospital1 Participants
HZ CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Ophtalmologist6 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Patient referred to the hospital1 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Angiologist0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitSick leave prescription1 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Ophtalmologist0 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Dermatologist1 Participants
PHN CohortEvaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical VisitMedical visit, Patient referred to a specialist1 Participants
Secondary

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.

Time frame: At inclusion (Month 0), Month 1, 3, 6 and 9

Population: Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria \& on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months \& followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild pain (1-2), Month 00 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild pain (1-2), Month 10 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild pain (1-2), Month 30 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild pain (1-2), Month 61 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild pain (1-2), Month 90 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 03 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 14 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 35 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 61 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 90 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 05 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 12 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 33 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 62 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 92 Participants
Secondary

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.

Time frame: At inclusion (Month 0), Month 1 and Month 3

Population: The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild pain (1-2), Month 07 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild Pain (1-2), Month 17 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireMild Pain (1-2), Month 310 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 042 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 123 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireModerate pain (3-6), Month 35 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 045 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 112 Participants
HZ CohortEvaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI QuestionnaireSevere pain (7-10), Month 33 Participants
Secondary

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

Time frame: At inclusion (Month 0), Month 1, 3, 6 and 9

Population: Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria \& on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months \& followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).

ArmMeasureGroupValue (MEDIAN)
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-5D-5L index value, Month 90.16 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-5D-5L index value, Month 00.70 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-5D-5L index value, Month 10.09 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-5D-5L index value, Month 3-0.02 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-5D-5L index value, Month 60.17 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-VAS health state, Month 077.50 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-VAS health state, Month 1-5.0 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-VAS health state, Month 3-10.0 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-VAS health state, Month 65.0 Quality of life score
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN CohortEQ-VAS health state, Month 90 Quality of life score
Secondary

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

Time frame: At inclusion (Month 0)

Population: The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

ArmMeasureGroupValue (MEAN)Dispersion
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L QuestionnarieEQ-5D-5L index value0.67 Quality of life scoreStandard Deviation 0.28
HZ CohortEvaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L QuestionnarieEQ-VAS health state68.38 Quality of life scoreStandard Deviation 19.13
PHN CohortEvaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L QuestionnarieEQ-5D-5L index value0.72 Quality of life scoreStandard Deviation 0.19
PHN CohortEvaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L QuestionnarieEQ-VAS health state73.13 Quality of life scoreStandard Deviation 12.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026