Herpes Zoster
Conditions
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
Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 Visit | At 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 Visits | Cumulatively up to Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | At inclusion (Month 0), Month 1 and Month 3 | 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. |
| Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | At 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 Cohort | At inclusion (Month 0), Month 1, 3, 6 and 9 | 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 |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete telephonic interviews | 9 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | HZ Cohort | — |
|---|---|---|
| Age, Continuous | 68.1 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 type | EG000 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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Antalgic-antipyretic, before inclusion | 10 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | NSAIDs, before inclusion | 3 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Systemic direct acting antiviral, before inclusion | 4 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Direct acting antiviral, at inclusion | 89 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Direct acting antiviral- systemic, at inclusion | 89 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Local cutaneous, at inclusion | 11 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Direct acting antiviral-Local ophthalmic-inclusion | 1 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | At least one Antalgic | 53 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Antalgic Level I | 27 Participants |
| HZ Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Antalgic Level II | 24 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | At least one Antalgic | 6 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Antalgic-antipyretic, before inclusion | 1 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Local cutaneous, at inclusion | 2 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | NSAIDs, before inclusion | 0 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Antalgic Level II | 3 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Systemic direct acting antiviral, before inclusion | 1 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Direct acting antiviral-Local ophthalmic-inclusion | 0 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Direct acting antiviral, at inclusion | 6 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Antalgic Level I | 3 Participants |
| PHN Cohort | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Direct acting antiviral- systemic, at inclusion | 6 Participants |
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, direct acting antiviral,Systemic | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, direct acting antiviral,Local | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level I | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level II | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Sick leave prescription | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Visits | 3 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, General practitioner | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Dermatologist | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Ophthalmologist | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Magnetizer | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Acupuncturist | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level II | 20 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Systemic | 80 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Magnetizer | 20 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Sick leave prescription | 5 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Acupuncturist | 3 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level I | 34 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Healer | 2 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, General practitioner | 89 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Osteopath | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Local | 12 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Radiologist | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Dermatologist | 6 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Rheumatologist | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Ophthalmologist | 2 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Rheumatologist | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Systemic | 4 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Local | 2 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level I | 6 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level II | 3 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Sick leave prescription | 1 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, General practitioner | 6 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Dermatologist | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Ophthalmologist | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Magnetizer | 3 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Acupuncturist | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Healer | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Osteopath | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visit, Radiologist | 0 Participants |
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Sick leave prescription | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Magnetizer | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, direct acting antiviral,Systemic | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, direct acting antiviral,Local | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level I | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Drugs prescribed, Antalgic Level II | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Visits | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, General practitioner | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Dermatologist | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Ophthalmologist | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Medical visits, Acupuncturist | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Sick leave prescription | 3 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Dermatologist | 3 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Patient referred to a specialist | 9 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Angiologist | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Patient referred to the hospital | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Ophtalmologist | 6 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Patient referred to the hospital | 1 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Angiologist | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Sick leave prescription | 1 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Ophtalmologist | 0 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Dermatologist | 1 Participants |
| PHN Cohort | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Medical visit, Patient referred to a specialist | 1 Participants |
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild pain (1-2), Month 0 | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild pain (1-2), Month 1 | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild pain (1-2), Month 3 | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild pain (1-2), Month 6 | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild pain (1-2), Month 9 | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 0 | 3 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 1 | 4 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 3 | 5 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 6 | 1 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 9 | 0 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 0 | 5 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 1 | 2 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 3 | 3 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 6 | 2 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 9 | 2 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild pain (1-2), Month 0 | 7 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild Pain (1-2), Month 1 | 7 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Mild Pain (1-2), Month 3 | 10 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 0 | 42 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 1 | 23 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Moderate pain (3-6), Month 3 | 5 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 0 | 45 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 1 | 12 Participants |
| HZ Cohort | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | Severe pain (7-10), Month 3 | 3 Participants |
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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-5D-5L index value, Month 9 | 0.16 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-5D-5L index value, Month 0 | 0.70 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-5D-5L index value, Month 1 | 0.09 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-5D-5L index value, Month 3 | -0.02 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-5D-5L index value, Month 6 | 0.17 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-VAS health state, Month 0 | 77.50 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-VAS health state, Month 1 | -5.0 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-VAS health state, Month 3 | -10.0 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-VAS health state, Month 6 | 5.0 Quality of life score |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | EQ-VAS health state, Month 9 | 0 Quality of life score |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | EQ-5D-5L index value | 0.67 Quality of life score | Standard Deviation 0.28 |
| HZ Cohort | Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | EQ-VAS health state | 68.38 Quality of life score | Standard Deviation 19.13 |
| PHN Cohort | Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | EQ-5D-5L index value | 0.72 Quality of life score | Standard Deviation 0.19 |
| PHN Cohort | Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | EQ-VAS health state | 73.13 Quality of life score | Standard Deviation 12.8 |