Postherpetic Neuralgia After Herpes Zoster and Risk of Incident Dementia: Real-World Evidence From an International Matched Cohort With Landmark Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68,786
- 试验地点
- 1
- 主要终点
- Incident all-cause dementia
研究概览
简要总结
This retrospective observational cohort study uses de-identified electronic health record data from the TriNetX Global Collaborative Network to evaluate whether postherpetic neuralgia after herpes zoster is associated with an increased risk of incident dementia. Adults aged 40 to 120 years with incident herpes zoster between 1 October 2015 and 31 December 2024 are identified using diagnostic codes. Postherpetic neuralgia is defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes B02.22 or B02.29 recorded between 90 and 365 days after the index herpes zoster date, and comparators have no such codes within 365 days after index. The primary analysis uses 1:1 propensity score matching and a 365-day landmark design, including only individuals alive and free of dementia at the landmark. Time-to-event analyses estimate hazard ratios for incident dementia and related outcomes.
详细描述
Data source and study design This is a retrospective cohort study using de-identified electronic health record data accessed through the TriNetX platform. The primary analysis is conducted in the TriNetX Global Collaborative Network. Replication is performed in the TriNetX Asia Pacific (APAC) network as a geographic validation.
Population and index date Eligible individuals are aged 40 to 120 years and have an incident herpes zoster diagnosis (ICD-10-CM B02) recorded between 1 October 2015 and 31 December 2024, with a 3-year washout period free of herpes zoster before the index date. Baseline covariates are assessed up to 1 day before the index date.
Exposure definition Postherpetic neuralgia is defined by ICD-10-CM codes B02.22 or B02.29 recorded between 90 and 365 days after the index date. The comparator cohort includes individuals with incident herpes zoster and no record of B02.22 or B02.29 within 365 days after the index date. A prespecified stricter exposure definition requires at least two postherpetic neuralgia codes separated by at least 30 days.
Landmark design and follow-up The primary analysis uses a 365-day landmark after the index date. Only individuals alive and free of the specified outcome at the landmark enter the risk set. Follow-up starts at the landmark and continues until the first record of the outcome, death, loss to follow-up, or 31 December 2024.
Matching and analysis Cohorts are matched 1:1 using nearest neighbour propensity score matching with a caliper of 0.1. Balance is assessed using standardised mean differences. Time-to-event analyses use Kaplan-Meier methods and Cox proportional hazards models, reporting hazard ratios with 95% confidence intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 120 years with an incident herpes zoster diagnosis recorded between 1 October 2015 and 31 December 2024 in the TriNetX network.
- •A 3-year washout period with no recorded herpes zoster diagnosis before the index date.
- •Eligible for analysis at the 365-day landmark after the index date, defined as being alive and free of the specified outcome at the landmark.
排除标准
- •Any record of the specified outcome before the 365-day landmark.
- •Missing data elements required to define exposure status within the prespecified time window.
研究组 & 干预措施
Postherpetic neuralgia (PHN)
Adults aged 40 to 120 years with incident herpes zoster between 1 October 2015 and 31 December 2024 who had a recorded postherpetic neuralgia diagnosis (ICD-10-CM B02.22 or B02.29) between 90 and 365 days after the index herpes zoster date. Follow-up begins at a 365-day landmark after index among individuals alive and free of dementia at the landmark.
干预措施: Exposure: postherpetic neuralgia (Other)
Non-PHN comparator
Adults aged 40 to 120 years with incident herpes zoster between 1 October 2015 and 31 December 2024 with no recorded postherpetic neuralgia diagnosis (ICD-10-CM B02.22 or B02.29) within 365 days after the index herpes zoster date. Follow-up begins at a 365-day landmark after index among individuals alive and free of dementia at the landmark.
结局指标
主要结局
Incident all-cause dementia
时间窗: From the 365-day landmark after the index herpes zoster date to the earliest of the first record of dementia, death, loss to follow-up, or 31 December 2024.
Incident all-cause dementia is identified using ICD-10-CM codes F01, F02, F03, or G30. Individuals with any record of dementia before the 365-day landmark are excluded from the risk set.
次要结局
- Alzheimer disease(From the 365-day landmark after the index herpes zoster date to the earliest of the first record of Alzheimer disease, death, loss to follow-up, or 31 December 2024.)
- Vascular dementia(From the 365-day landmark after the index herpes zoster date to the earliest of the first record of vascular dementia, death, loss to follow-up, or 31 December 2024.)
- Other or unspecified dementia(From the 365-day landmark after the index herpes zoster date to the earliest of the first record of other or unspecified dementia, death, loss to follow-up, or 31 December 2024.)
- All-cause mortality(From the 365-day landmark after the index herpes zoster date to the earliest of death, loss to follow-up, or 31 December 2024.)
- Ischaemic stroke(From the 365-day landmark after the index herpes zoster date to the earliest of the first record of ischaemic stroke, death, loss to follow-up, or 31 December 2024.)
- Hip fracture(From the 365-day landmark after the index herpes zoster date to the earliest of the first record of hip fracture, death, loss to follow-up, or 31 December 2024.)