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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02487472
• Collaborator: (none)
• Enrollment: 106
• Actual Duration (Months): 19.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster	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 Design

• Study Type: Observational
• Actual Enrollment: 106 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study
• Actual Study Start Date: Jan 19, 2016
• Actual Primary Completion Date: Aug 28, 2017
• Actual Study Completion Date: Aug 28, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits [From Month 3 to Month 6]

   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

5. Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits [From Month 6 to Month 9]

   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

Secondary Outcome Measures

1. 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.

2. Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire [At inclusion (Month 0), Month 1, 3, 6 and 9]

   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.

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Oct 17, 2014
• Statistical Analysis Plan - Nov 3, 2017

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02487472
• Other Study ID Numbers: 201926
• First Posted: Jul 1, 2015
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by GlaxoSmithKline: France; Post-herpetic neuralgia; Herpes zoster; Economic burden of disease
• Additional relevant MeSH terms: Herpes Simplex; Herpes Zoster; Neuralgia; Neuralgia, Postherpetic

Study Results

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 Detail	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.

Arm/Group Title	HZ Cohort
Arm/Group Description	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).
Period Title: Overall Study
STARTED	101
COMPLETED	90
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	HZ Cohort
Arm/Group Description	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).
Overall Participants	101
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.1 (10.3)
Sex: Female, Male (Count of Participants)
Female	56 55.4%
Male	45 44.6%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	HZ Cohort	PHN Cohort
Arm/Group Description	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).	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	101	8
Antalgic-antipyretic, before inclusion	10 9.9%	1 NaN
NSAIDs, before inclusion	3 3%	0 NaN
Systemic direct acting antiviral, before inclusion	4 4%	1 NaN
Direct acting antiviral, at inclusion	89 88.1%	6 NaN
Direct acting antiviral- systemic, at inclusion	89 88.1%	6 NaN
Local cutaneous, at inclusion	11 10.9%	2 NaN
Direct acting antiviral-Local ophthalmic-inclusion	1 1%	0 NaN
At least one Antalgic	53 52.5%	6 NaN
Antalgic Level I	27 26.7%	3 NaN
Antalgic Level II	24 23.8%	3 NaN

2. Primary Outcome

Title	Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	HZ Cohort	PHN Cohort
Arm/Group Description	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).	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	101	8
Sick leave prescription	3 3%	1 NaN
Medical visit, Patient referred to a specialist	9 8.9%	1 NaN
Medical visit, Ophtalmologist	6 5.9%	0 NaN
Medical visit, Dermatologist	3 3%	1 NaN
Medical visit, Angiologist	1 1%	0 NaN
Medical visit, Patient referred to the hospital	1 1%	1 NaN

3. Primary Outcome

Title	Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HZ Cohort	PHN Cohort
Arm/Group Description	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).	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	90	6
Drugs prescribed, Systemic	80 79.2%	4 NaN
Drugs prescribed, Local	12 11.9%	2 NaN
Drugs prescribed, Antalgic Level I	34 33.7%	6 NaN
Drugs prescribed, Antalgic Level II	20 19.8%	3 NaN
Sick leave prescription	5 5%	1 NaN
Medical visit, General practitioner	89 88.1%	6 NaN
Medical visit, Dermatologist	6 5.9%	0 NaN
Medical visit, Ophthalmologist	2 2%	0 NaN
Medical visit, Magnetizer	20 19.8%	3 NaN
Medical visit, Acupuncturist	3 3%	0 NaN
Medical visit, Healer	2 2%	0 NaN
Medical visit, Osteopath	1 1%	0 NaN
Medical visit, Radiologist	1 1%	0 NaN
Medical visit, Rheumatologist	1 1%	0 NaN

4. Primary Outcome

Title	Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PHN Cohort
Arm/Group Description	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	6
Drugs prescribed, direct acting antiviral,Systemic	0 0%
Drugs prescribed, direct acting antiviral,Local	0 0%
Drugs prescribed, Antalgic Level I	1 1%
Drugs prescribed, Antalgic Level II	0 0%
Sick leave prescription	0 0%
Medical visits, Visits	3 3%
Medical visits, General practitioner	0 0%
Medical visits, Dermatologist	0 0%
Medical visits, Ophthalmologist	0 0%
Medical visits, Magnetizer	0 0%
Medical visits, Acupuncturist	0 0%

5. Secondary Outcome

Title	Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	HZ Cohort
Arm/Group Description	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).
Measure Participants	101
Mild pain (1-2), Month 0	7 6.9%
Mild Pain (1-2), Month 1	7 6.9%
Mild Pain (1-2), Month 3	10 9.9%
Moderate pain (3-6), Month 0	42 41.6%
Moderate pain (3-6), Month 1	23 22.8%
Moderate pain (3-6), Month 3	5 5%
Severe pain (7-10), Month 0	45 44.6%
Severe pain (7-10), Month 1	12 11.9%
Severe pain (7-10), Month 3	3 3%

6. Secondary Outcome

Title	Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PHN Cohort
Arm/Group Description	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	8
Mild pain (1-2), Month 0	0 0%
Mild pain (1-2), Month 1	0 0%
Mild pain (1-2), Month 3	0 0%
Mild pain (1-2), Month 6	1 1%
Mild pain (1-2), Month 9	0 0%
Moderate pain (3-6), Month 0	3 3%
Moderate pain (3-6), Month 1	4 4%
Moderate pain (3-6), Month 3	5 5%
Moderate pain (3-6), Month 6	1 1%
Moderate pain (3-6), Month 9	0 0%
Severe pain (7-10), Month 0	5 5%
Severe pain (7-10), Month 1	2 2%
Severe pain (7-10), Month 3	3 3%
Severe pain (7-10), Month 6	2 2%
Severe pain (7-10), Month 9	2 2%

7. Secondary Outcome

Title	Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	HZ Cohort	PHN Cohort
Arm/Group Description	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).	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	101	8
EQ-5D-5L index value	0.67 (0.28)	0.72 (0.19)
EQ-VAS health state	68.38 (19.13)	73.13 (12.80)

8. Secondary Outcome

Title	Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PHN Cohort
Arm/Group Description	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	8
EQ-5D-5L index value, Month 0	0.70
EQ-5D-5L index value, Month 1	0.09
EQ-5D-5L index value, Month 3	-0.02
EQ-5D-5L index value, Month 6	0.17
EQ-5D-5L index value, Month 9	0.16
EQ-VAS health state, Month 0	77.50
EQ-VAS health state, Month 1	-5.0
EQ-VAS health state, Month 3	-10.0
EQ-VAS health state, Month 6	5.0
EQ-VAS health state, Month 9	0

9. Primary Outcome

Title	Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PHN Cohort
Arm/Group Description	All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Measure Participants	6
Drugs prescribed, direct acting antiviral,Systemic	0 0%
Drugs prescribed, direct acting antiviral,Local	0 0%
Drugs prescribed, Antalgic Level I	0 0%
Drugs prescribed, Antalgic Level II	0 0%
Sick leave prescription	1 1%
Medical visits, Visits	0 0%
Medical visits, General practitioner	0 0%
Medical visits, Dermatologist	0 0%
Medical visits, Ophthalmologist	0 0%
Medical visits, Magnetizer	0 0%
Medical visits, Acupuncturist	0 0%

Adverse Events

Time Frame	No adverse events data were collected.
Adverse Event Reporting Description	No adverse events data were collected
Arm/Group Title	HZ Cohort
Arm/Group Description	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).
All Cause Mortality
	HZ Cohort
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	HZ Cohort
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	HZ Cohort
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.