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Title: Impact on quality of life and disease burden in adults with herpes zoster
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
Impact on quality of life and disease burden in adults with herpes zoster Contents
HYPOTHESIS AND OBJECTIVES OF THE STUDY 3.1 Hypothesis: Herpes zoster significantly affects the quality of life of those who suffer from it with a high disease burden.
3.2 Primary outcomes: To measure the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Fundación Jiménez Díaz University Hospital.
3.3 Secondary outcomes
TYPE OF STUDY AND DESIGN
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
SUBJECT SELECTION 5.1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunised against HZ
Exclusion criteria:
ICD 9 053 Herpes zoster Includes:
Herpes zoster Zone 053.0 With meningitis 053.1 With other central nervous system complications 053.10 With unspecified nervous system complications 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis 053.12 Postherpetic trigeminal neuralgia 053.13 Postherpetic polyneuropathy 053.14 Herpes zoster myelitis 053.19 Other 053.2 With ophthalmic complications 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus 053.21 Herpes zoster keraconjunctivitis 053.22 Herpes zoster iridocyclitis 053.29 Other 053.7 With other complications specific 053.71 Otitis externa due to herpes zoster 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster Includes: - herpes - zone B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to herpes zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement B02.21 Postherpetic geniculate ganglionitis B02.22 Postherpetic trigeminal neuralgia B02.23 Postherpetic polyneuropathy B.02.24 Postherpetic myelitis or Herpes zoster myelitis B02.29 Other postherpetic nervous system involvement or Postherpetic radiculopathy B02.3 Ocular herpes zoster B02.30 Ocular herpes zoster, unspecified B02.31 Herpes zoster conjunctivitis B02.32 Herpes zoster iridocyclitis B02.33 Herpes zoster keratitis or Herpes zoster keratoconjunctivitis B02.34 Herpes zoster scleritis B02.39 Other herpes zoster eye diseases or Herpes zoster blepharitis B02.7 Disseminated herpes zoster B02.8 Herpes zoster with other complications Herpes zoster otitis externa B02.9 Uncomplicated herpes zoster Herpes zoster
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients > 18 years old who are going to be immunized against HZ | Patients > 18 years old who are going to be immunized against HZ |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital. | Measuring the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital. | Data will be collected for 1 year and then analyzed to respond to the outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life according to the location of herpes zoster | Evaluate quality of life according to the location of herpes zoster (postherpetic neuralgia, ophthalmic zoster, etc.) | Data will be collected for 1 year and then analyzed to respond to the outcome |
| Effectiveness of the vaccine against herpes zoster |
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1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunized against HZ
Exclusion criteria:
ICD 9 053 Herpes zoster
Includes:
Includes:
Exclusion criteria:
Patients who are vaccinated against HZV
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Prospective study:
Patients > 18 years of age who are to be immunized against HZ
Retrospective study:
Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital.
Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below.
Patients diagnosed with herpes zoster (HZ). Study Population and Total Number of Patients: Based on the sample calculation, it is intended to include a total of 357 patients in the prospective study and 1,920 patients in the retrospective study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
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| Label | URL |
|---|---|
| Patil A. Goldust M. Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. \[Internet\]. 2022. \[Consultado 18 Feb 2024\]; 14(2) | View source |
| Kain A., Tizek L., Wecker H., Wallnöfer F., Biedermann T., Zink A. Evaluating public interest in herpes zoster in Germany by leveraging the internet: a retrospective search data analysis. BMC Public Health. \[Internet\]. 2023. \[Consultado 29 Mar 2024\]; 2 | View source |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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Evaluating the effectiveness of the herpes zoster vaccine in terms of the number of episodes, severity and quality of life. |
| Data will be collected for 1 year and then analyzed to respond to the objective |
| Economic impact and disease burden in terms of morbidity and mortality | Economic impact and burden of disease in terms of morbidity and mortality of adult patients with herpes zoster | A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months. |
| Masa Calles J. López Perca N. Vila Cordero B. Carmona R. Vigilancia y epidemiología del herpes zóster en España. RevEsp Salud Pública.\[Internet\]. 2021. \[Consultado 18 Feb 2024\]; 95. (e1-13). | View source |
| Centro Nacional de Epidemiología. CIBERESP. Instituto de Salud Carlos III. Informe epidemiológico sobre la situación del Herpes Zóster en España. \[Internet\]. 2020. \[Consultado 18 Feb 2024\]. | View source |
| Patkia A., Vorab A., Parikh R., Kolhapure S., Agrawal A., Dash R. Herpes zoster in outpatient departments of healthcare centers in India: a review of literatura. Human vaccines\&immunotherapeutics. \[Internet\]. 2021. \[Consultado 29 Mar 2024\]. | View source |
| Ralph Tayyar R., Ho D. Herpes Simplex Virus and Varicella Zoster Virus Infections in Cancer Patients. Viruses. \[Internet\]. 2023. \[Consultado 28 Mar 2024\];15, 439. | View source |
| Van Oorschot D., McGirr A., Goulet P., Koochaki P., Pratiwadi R., Shah S., Curran D. A Cross-Sectional Concept Elicitation Study to Understand the Impact of Herpes Zoster on Patients' Health-Related Quality of Life. InfectDisTher. \[Internet\]. 2022. | View source |
| Sollie M., Jepsen P., Sørensen, JA. (2022). Patient-reported quality of life in patients suffering from acute herpes zoster-a systematic review with meta-analysis. British journal of pain. \[Internet\]. 2022. \[Consultado 28 Mar 2024\]; 15 16(4), 404-419. | View source |
| Díez Domingo J., Curran D., Cambronero MR., Garcia Martinez JA., Matthews S. Economic Burden and Impact on Quality of Life of Herpes Zoster in Spanish Adults Aged 50 Years or Older: A Prospective Cohort Study. Advances in therapy. \[Internet\]. 2021. \[C | View source |
| Matthews S., De Maria A., Passamonti M.,Ristori G., Loiacono I., Puggina A., Curran D. The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy. Open ForumInfectDis. \[ | View source |
| Zhao D, Suo L., Lu L., Pan J., Peng X., Wang Y., Pang X. Impact of herpes zoster and post-herpetic neuralgia on health-relate. Vaccine X. \[Internet\]. 2023. \[Consultado 28 Mar 2024\]; 15, 100415. | View source |
| Curran D., Hunjan M., El Ghachi A., El-Hahi Y., Bianco V., Ferreira G. Herpes zoster related healthcare burden and costs in immunocompromised (IC) and IC-free populations in England: an observational retrospective database analysis. BMJ Open. \[Interne | View source |
| Chen L., Li J., Liu H., Yang P., Zuo Y., Ye L. Interventions for zoster-associated pain: A retrospective study based on the clinical database.Front Neurol. \[Internet\]. 2022. \[Consultado 29 Mar 2024\];13:1056171. | View source |
| Lin CS., Lin YC., Lao HC., Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. \[Internet\]. 2019. \[Consultado 28 Mar 2024\]; 22,209-228. | View source |
| Zeng F., Wang M., Zhang D. Cost-effectiveness analysis of 5% lidocaine-medicated plaster compared with pregabalin for the treatment of post-herpetic neuralgia in China.Pain and therapy. \[Internet\]. 2021. \[Consultado 30 Mar 2024\]; 10(1), 675-689. | View source |
| Sollie M., Jepsen P., Sorensen JA. Patient-reported quality of life in patients suffering from acute herpes zoster-a systematic review with meta-analysis. British Journal of Pain. \[Internet\]. 2022. \[Consultado 18 Feb 2024\]; 16(4) 404-419. | View source |
| Hideo Hashizumea H., NakataniaE. ,Satoa Y., Gotoc H. , Yagic H., Miyachi Y. A new susceptibility index to predict the risk of severe herpes zoster-associated pain: A Japanese regional population-based cohort study, the Shizuoka study. Journal of Derma | View source |
| Centro Nacional de Epidemiología. CIBERESP. Instituto de Salud Carlos III. Informe epidemiológico sobre la situación del Herpes Zóster en España. \[Internet\]. Madrid; 2020. \[Consultado 18 Feb 2024\]. | View source |
| Sicras-Mainar A., Navarro-Artieda R., Ibanez-Nolla J., Perez-Ronco J. Incidence, resource use and costs associated with postherpetic neuralgia: a population-based retrospective study. Rev Neurol. . \[Internet\].2012\[Consultado 10 Abr 2024\]; 55:449-461. | View source |