Trial Outcomes & Findings for Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France (NCT NCT02487472)
NCT ID: NCT02487472
Last Updated: 2019-09-04
Results Overview
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.
COMPLETED
106 participants
Before inclusion and at inclusion (Month 0)
2019-09-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Did not complete telephonic interviews
|
9
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HZ Cohort
n=101 Participants
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).
|
|---|---|
|
Age, Continuous
|
68.1 Years
STANDARD_DEVIATION 10.3 • n=101 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
HZ Cohort
n=101 Participants
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).
|
PHN Cohort
n=8 Participants
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).
|
|---|---|---|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Antalgic Level I
|
27 Participants
|
3 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Antalgic Level II
|
24 Participants
|
3 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Antalgic-antipyretic, before inclusion
|
10 Participants
|
1 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
NSAIDs, before inclusion
|
3 Participants
|
0 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Systemic direct acting antiviral, before inclusion
|
4 Participants
|
1 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Direct acting antiviral, at inclusion
|
89 Participants
|
6 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Direct acting antiviral- systemic, at inclusion
|
89 Participants
|
6 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Local cutaneous, at inclusion
|
11 Participants
|
2 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Direct acting antiviral-Local ophthalmic-inclusion
|
1 Participants
|
0 Participants
|
|
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
At least one Antalgic
|
53 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
HZ Cohort
n=101 Participants
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).
|
PHN Cohort
n=8 Participants
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).
|
|---|---|---|
|
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Sick leave prescription
|
3 Participants
|
1 Participants
|
|
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
|
1 Participants
|
|
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Medical visit, Ophtalmologist
|
6 Participants
|
0 Participants
|
|
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Medical visit, Dermatologist
|
3 Participants
|
1 Participants
|
|
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Medical visit, Angiologist
|
1 Participants
|
0 Participants
|
|
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
|
1 Participants
|
PRIMARY outcome
Timeframe: Cumulatively up to Month 3Population: 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.
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.
Outcome measures
| Measure |
HZ Cohort
n=90 Participants
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).
|
PHN Cohort
n=6 Participants
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).
|
|---|---|---|
|
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
|
1 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
4 Participants
|
|
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
|
2 Participants
|
|
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
|
6 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
3 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 3 to Month 6Population: 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).
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
Outcome measures
| Measure |
HZ Cohort
n=6 Participants
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).
|
PHN Cohort
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).
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
PRIMARY outcome
Timeframe: From Month 6 to Month 9Population: 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).
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
Outcome measures
| Measure |
HZ Cohort
n=6 Participants
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).
|
PHN Cohort
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).
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: At inclusion (Month 0), Month 1 and Month 3Population: 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.
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.
Outcome measures
| Measure |
HZ Cohort
n=101 Participants
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).
|
PHN Cohort
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).
|
|---|---|---|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Severe pain (7-10), Month 1
|
12 Participants
|
—
|
|
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 HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild pain (1-2), Month 0
|
7 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild Pain (1-2), Month 1
|
7 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild Pain (1-2), Month 3
|
10 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 0
|
42 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 1
|
23 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 3
|
5 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Severe pain (7-10), Month 0
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: At inclusion (Month 0), Month 1, 3, 6 and 9Population: 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).
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.
Outcome measures
| Measure |
HZ Cohort
n=8 Participants
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).
|
PHN Cohort
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).
|
|---|---|---|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 3
|
5 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 6
|
1 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild pain (1-2), Month 0
|
0 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild pain (1-2), Month 1
|
0 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild pain (1-2), Month 3
|
0 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild pain (1-2), Month 6
|
1 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Mild pain (1-2), Month 9
|
0 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 0
|
3 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 1
|
4 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Moderate pain (3-6), Month 9
|
0 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Severe pain (7-10), Month 0
|
5 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Severe pain (7-10), Month 1
|
2 Participants
|
—
|
|
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 HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Severe pain (7-10), Month 6
|
2 Participants
|
—
|
|
Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Severe pain (7-10), Month 9
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
HZ Cohort
n=101 Participants
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).
|
PHN Cohort
n=8 Participants
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).
|
|---|---|---|
|
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
|
0.72 Quality of life score
Standard Deviation 0.19
|
|
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
|
73.13 Quality of life score
Standard Deviation 12.80
|
SECONDARY outcome
Timeframe: At inclusion (Month 0), Month 1, 3, 6 and 9Population: 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).
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
Outcome measures
| Measure |
HZ Cohort
n=8 Participants
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).
|
PHN Cohort
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).
|
|---|---|---|
|
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
Interval 0.4 to 1.0
|
—
|
|
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
Interval -0.51 to 0.26
|
—
|
|
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
Interval -0.22 to 0.51
|
—
|
|
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
Interval 0.0 to 0.4
|
—
|
|
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
Interval 0.0 to 0.37
|
—
|
|
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
Interval 50.0 to 90.0
|
—
|
|
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
Interval -50.0 to 20.0
|
—
|
|
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
Interval -30.0 to 10.0
|
—
|
|
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
Interval -30.0 to 24.0
|
—
|
|
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
Interval -30.0 to 24.0
|
—
|
Adverse Events
HZ Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER