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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Evaluation of HZ and PHN related direct medical costs were done by the drugs prescribed before and at inclusion. The drugs prescribed were defined as a direct cost. | Before inclusion and at inclusion (Month 0) |
| Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Evaluation of HZ and PHN related indirect costs, estimated by direct medical costs were done by the sick leave prescription and medical visit at inclusion. Sick leave prescriptions were defined as an indirect medical cost and medical visits were defined as a direct medical cost. | At Inclusion (Month 0) |
| Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Evaluation of HZ and PHN related direct medical costs were done by drugs prescribed, sick leaves prescribed, medical visits to a specialist and patient reference to a hospital. | Cumulatively up to Month 3 |
| Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 3 to month 6 for the PHN cohort | From Month 3 to Month 6 |
| Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 6 to month 9 for the PHN cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | HZ and PHN severity was evaluated using 3 categories- mild pain (0\ |
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Inclusion Criteria:
For HZ cohort
For PHN cohort
Exclusion Criteria:
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The study has been designed to include 250 patients ≥ 50 years old with a first visit for diagnosis of HZ during a 6-month inclusion period (HZ cohort) and 40 expected cases of PHN after 3 months of HZ rash onset.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. | Evaluation of HZ and PHN related direct medical costs were done by the drugs prescribed before and at inclusion. The drugs prescribed were defined as a direct cost. | 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. | Posted | Count of Participants | Participants | Before inclusion and at inclusion (Month 0) |
|
No adverse events data were collected.
No adverse events data were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | lzr30020@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2014 | Jan 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2017 | Jan 9, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| From Month 6 to Month 9 |
| At inclusion (Month 0), Month 1 and Month 3 |
| Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | HZ and PHN severity was evaluated using 3 categories- mild pain (0\ | At inclusion (Month 0), Month 1, 3, 6 and 9 |
| Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single mean index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A mean of this health state was recorded for subjects analyzed in this outcome measure | At inclusion (Month 0) |
| Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A median of this health state was recorded for subjects analyzed in this outcome measure | At inclusion (Month 0), Month 1, 3, 6 and 9 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
| Primary | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit | Evaluation of HZ and PHN related indirect costs, estimated by direct medical costs were done by the sick leave prescription and medical visit at inclusion. Sick leave prescriptions were defined as an indirect medical cost and medical visits were defined as a direct medical cost. | 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. | Posted | Count of Participants | Participants | At Inclusion (Month 0) |
|
|
|
| Primary | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Evaluation of HZ and PHN related direct medical costs were done by drugs prescribed, sick leaves prescribed, medical visits to a specialist and patient reference to a hospital. | 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. | Posted | Count of Participants | Participants | Cumulatively up to Month 3 |
|
|
|
| Primary | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 3 to month 6 for the PHN cohort | 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). | Posted | Count of Participants | Participants | From Month 3 to Month 6 |
|
|
|
| Secondary | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | HZ and PHN severity was evaluated using 3 categories- mild pain (0\ | 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. | Posted | Count of Participants | Participants | At inclusion (Month 0), Month 1 and Month 3 |
|
|
|
| Secondary | Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire | HZ and PHN severity was evaluated using 3 categories- mild pain (0\ | 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). | Posted | Count of Participants | Participants | At inclusion (Month 0), Month 1, 3, 6 and 9 |
|
|
|
| Secondary | Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie | Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single mean index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A mean of this health state was recorded for subjects analyzed in this outcome measure | 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. | Posted | Mean | Standard Deviation | Quality of life score | At inclusion (Month 0) |
|
|
|
| Secondary | Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort | Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A median of this health state was recorded for subjects analyzed in this outcome measure | 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). | Posted | Median | Inter-Quartile Range | Quality of life score | At inclusion (Month 0), Month 1, 3, 6 and 9 |
|
|
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| Primary | Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits | Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 6 to month 9 for the PHN cohort | 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). | Posted | Count of Participants | Participants | From Month 6 to Month 9 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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.
| D007239 | Infections |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Medical visit, Ophtalmologist |
|
| Medical visit, Dermatologist |
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| Medical visit, Angiologist |
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| Medical visit, Patient referred to the hospital |
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| Drugs prescribed, Antalgic Level I |
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| Drugs prescribed, Antalgic Level II |
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| Sick leave prescription |
|
| Medical visit, General practitioner |
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| Medical visit, Dermatologist |
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| Medical visit, Ophthalmologist |
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| Medical visit, Magnetizer |
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| Medical visit, Acupuncturist |
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| Medical visit, Healer |
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| Medical visit, Osteopath |
|
| Medical visit, Radiologist |
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| Medical visit, Rheumatologist |
|
| Title | Measurements |
|---|---|
|
| Drugs prescribed, Antalgic Level II |
|
| Sick leave prescription |
|
| Medical visits, Visits |
|
| Medical visits, General practitioner |
|
| Medical visits, Dermatologist |
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| Medical visits, Ophthalmologist |
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| Medical visits, Magnetizer |
|
| Medical visits, Acupuncturist |
|
| Title | Measurements |
|---|---|
|
| Moderate pain (3-6), Month 0 |
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| Moderate pain (3-6), Month 1 |
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| Moderate pain (3-6), Month 3 |
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| Severe pain (7-10), Month 0 |
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| Severe pain (7-10), Month 1 |
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| Severe pain (7-10), Month 3 |
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| Mild pain (1-2), Month 3 |
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| Mild pain (1-2), Month 6 |
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| Mild pain (1-2), Month 9 |
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| Moderate pain (3-6), Month 0 |
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| Moderate pain (3-6), Month 1 |
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| Moderate pain (3-6), Month 3 |
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| Moderate pain (3-6), Month 6 |
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| Moderate pain (3-6), Month 9 |
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| Severe pain (7-10), Month 0 |
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| Severe pain (7-10), Month 1 |
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| Severe pain (7-10), Month 3 |
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| Severe pain (7-10), Month 6 |
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| Severe pain (7-10), Month 9 |
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| EQ-5D-5L index value, Month 3 |
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| EQ-5D-5L index value, Month 6 |
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| EQ-5D-5L index value, Month 9 |
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| EQ-VAS health state, Month 0 |
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| EQ-VAS health state, Month 1 |
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| EQ-VAS health state, Month 3 |
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| EQ-VAS health state, Month 6 |
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| EQ-VAS health state, Month 9 |
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| Title | Measurements |
|---|---|
|
| Drugs prescribed, Antalgic Level II |
|
| Sick leave prescription |
|
| Medical visits, Visits |
|
| Medical visits, General practitioner |
|
| Medical visits, Dermatologist |
|
| Medical visits, Ophthalmologist |
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| Medical visits, Magnetizer |
|
| Medical visits, Acupuncturist |
|