The purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.
The surveillance/recruitment period will take approximately 2 years and once the enrolment of HZ patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential PHN cases. The data will be captured at protocol specified time-points based on the time of enrolment of each subject.
Study Type
OBSERVATIONAL
Enrollment
395
HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
A case of HZ was defined as new unilateral pain (broadly defined to include allodynia and pruritus) accompanied by unilateral rash and no alternative diagnosis. Age ranges were 50-54, 55-59, 60-64, 65-69, 70-74, 75-79 and greater than or equal to (≥) 80 years. The incidence rate was expressed as the number of HZ cases per (/) 1000 person-years.
Time frame: Day 0 to 2 years
Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall
PHN persistence refers to pain occurring or persisting from Day 90 to Day 270 after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.
Time frame: At Day 90, 180 and 270 after onset of HZ
General Medical History of Cases With HZ, Overall
General medical history focused on characteristics such as patient pre-existing condition and diseases (local trauma, diabetes mellitus, liver disease, alcoholism, renal failure/dialysis, emotional problems, stress or depression, blood malignancy, solid malignancy, hematopoetic cell/ bone marrow transplant, solid organ transplantation, HIV infection, hepatitis C under active therapy, autoimmune disease active and under therapy, other).
Time frame: Between Day 0 and Day 270.
Other General Medical History Characteristics for HZ Cases, Overall
Other general medical history characteristics referred to arterial problems, cerebral problems, gastric problems, gastric problems, prostate problems (arterial hypertension and allergic rhinitis, arterial hypertension and pacemaker, arteriopathy and past nun-Hodgkin lymphoma, atrial fibrillation, bronchopathy, cerebral thrombosis, cholecyst, chronic cerebral ischemia, chronic leukemia, chronic obstructive pulmonary disease, epilepsy, gastric lymphoma, gastropathy, hypertension, hypertension and hypothyroidism after surgery, hypertension dyslipidemia and hyperthyroidism, hypothyroidism hypertension, polycythaemia, polycythaemia from 10 years, prostate neoplasm, prostate oral anticoagulant therapy cardiopathy, prostatic cancer, right feet arthralgia, thrombocytopenia, vasculopathy chronic brain).
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GSK Investigational Site
Cavallino (LE), Apulia, Italy
GSK Investigational Site
Copertino (LE), Apulia, Italy
GSK Investigational Site
Cutrofiano (LE), Apulia, Italy
GSK Investigational Site
Galatina (LE), Apulia, Italy
GSK Investigational Site
Montesano S. (LE), Apulia, Italy
GSK Investigational Site
Parabita (LE), Apulia, Italy
GSK Investigational Site
Specchia (LE), Apulia, Italy
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Rome, Lazio, Italy
...and 33 more locations
Time frame: Between Day 0 and Day 270.
Clinical Information of Cases With HZ, Overall
Clinical information of HZ cases referred to experience of any symptoms before rash, actual symptoms before rash (SBR), any complications at initial visit.
Time frame: Between Day 0 and Day 270
Complications Related to HZ Cases, Overall
HZ related complications refer to cutaneous complications (Varicella Zoster Virus \[VZV\] dissemination, Bacterial superinfection), ocular (Loss of corneal sensation, Keratitis, Scleritis, Uveitis, Iridocyclitis), neurological (Meningo-encephalitis, Cranial nerve palsies, Peripheral nerve palsies, Ramsay-Hunt syndrome, Persistent HZ-related Pain), visceral \[Neural extension of VZV infection (bronchitis, esophagitis,cystitis), VZV dissemination (pneumonia, arthritis, hepatitis\] and other.
Time frame: Between Day 0 and Day 270
Other Complications Related to HZ Cases, Overall
HZ related other complications refer to axillary lympagenopathy, burning sensation, hypoacusis, itching and rectum pain.
Time frame: Between Day 0 and Day 270
Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs.
Time frame: Up to Day 90
Worst Pain Assessment in HZ Subjects
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Time frame: At Day 90
Average Pain Assessment in HZ Subjects
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Time frame: At Day 90
Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.
Time frame: At Day 0, 15, 30, 60, 90
Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index/scale goes from 0 (worst health state) to 1 (perfect health state).
Time frame: At Day 0, 15, 30, 60, 90
PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective
Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs.
Time frame: Between Day 90 and Day 270
Worst Pain Assessment in PHN Subjects
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Time frame: At Day 90
Average Pain Assessment in PHN Subjects
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. The ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Time frame: At Day 90
Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.
Time frame: At Day 0, 15, 30, 60, 90
Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 1 (best health state).
Time frame: At Day 0, 15, 30, 60, 90