PDF(Pubmed)
Abstract：
Dengue is the most prevalent arboviral infection causing an estimated 50-60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment, lacking standardization in timepoints and symptom assessment. This study aimed to evaluate the content validity of the novel \'Dengue Virus Daily Diary (DENV-DD)\', designed to measure symptom intensity and disease burden within outpatient infant to adult populations.
The Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness.
Forty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3-15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion.
Findings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies.
Dengue is the most common viral infection transmitted to humans by mosquitos, and affects an estimated 50–60 million individuals globally per year. However, there are few resources for understanding and capturing the patient experience of dengue throughout illness. Most research studies are based on healthcare provider assessment, which lack consistency in terms of assessment time points and the signs/symptoms assessed. The ‘Dengue Illness Index Report Card (DII-RC)’ was used as a foundation to create the new ‘Dengue Virus Daily Diary (DENV-DD)’ to better capture the patient experience of symptom intensity and dengue disease burden for the duration of illness. Forty-eight individuals and caregivers of younger children from Peru and Ecuador who recently had symptomatic dengue were interviewed to understand the patient experience over the time of illness and to test whether the DENV-DD is understood by patients and caregivers and includes all relevant and important signs/symptoms and health-related quality of life impacts. Nine individuals with active dengue infection also completed the DENV-DD daily for 28-days as part of a clinical study. We found that > 70% of patients experienced fever, headache, body ache/pain, loss of appetite and body weakness. The DENV-DD instructions, questions and response option(s) were well understood, feasible to complete and the concepts assessed by the DENV-DD were relevant to the dengue experience. Our study adds to the understanding of the dengue illness experience and supports the DENV-DD for use in future dengue studies as an assessment of signs/symptoms throughout the duration of illness.
The Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness.
Forty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3-15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion.
Findings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies.
Dengue is the most common viral infection transmitted to humans by mosquitos, and affects an estimated 50–60 million individuals globally per year. However, there are few resources for understanding and capturing the patient experience of dengue throughout illness. Most research studies are based on healthcare provider assessment, which lack consistency in terms of assessment time points and the signs/symptoms assessed. The ‘Dengue Illness Index Report Card (DII-RC)’ was used as a foundation to create the new ‘Dengue Virus Daily Diary (DENV-DD)’ to better capture the patient experience of symptom intensity and dengue disease burden for the duration of illness. Forty-eight individuals and caregivers of younger children from Peru and Ecuador who recently had symptomatic dengue were interviewed to understand the patient experience over the time of illness and to test whether the DENV-DD is understood by patients and caregivers and includes all relevant and important signs/symptoms and health-related quality of life impacts. Nine individuals with active dengue infection also completed the DENV-DD daily for 28-days as part of a clinical study. We found that > 70% of patients experienced fever, headache, body ache/pain, loss of appetite and body weakness. The DENV-DD instructions, questions and response option(s) were well understood, feasible to complete and the concepts assessed by the DENV-DD were relevant to the dengue experience. Our study adds to the understanding of the dengue illness experience and supports the DENV-DD for use in future dengue studies as an assessment of signs/symptoms throughout the duration of illness.
摘要：
背景：登革热是最普遍的虫媒病毒感染，每年在全球造成50-60万例高热疾病。造成相当大的疾病负担。很少有工具可以评估患者的疾病经历，大部分基于医疗保健提供者的评估，缺乏时间点和症状评估的标准化。本研究旨在评估新型登革热病毒日报（DENV-DD）的内容效度，旨在衡量门诊婴儿对成人人群的症状强度和疾病负担。
方法：登革热疾病指数报告卡被用作创建DENV-DD的基础，由患者和观察者报告的结果（PRO/ObsRO）仪器组成。在南美的两个登革热流行社区中，我们对有症状的实验室确诊登革热患儿的个体和照顾者进行了定性联合概念启发和认知汇报访谈.访谈分为两轮，允许DENV-DD修改。还使用来自独立登革热人感染模型（DHIM）的数据对DENV-DD进行了小规模定量评估，以产生DENV-DD完成可行性的早期证据。仪器性能和对疾病过程中体征/症状轨迹的洞察力。
结果：对48名参与者进行了访谈（20名成年人，20名年龄较大的儿童/青少年及其照顾者，8名年幼儿童的看护人)。据报道，发烧持续3-15天的各种体征/症状，头痛,身体疼痛/疼痛，食欲不振,>70%的参与者报告了身体虚弱。DENV-DD说明,项目和反应量表被理解，和项目被认为是相关的不同年龄。DHIM数据支持DENV-DD完成的可行性。
结论：研究结果表明DENV-DD（PRO/ObsRO仪器）在登革热流行人群中的含量有效性。心理测量和文化有效性研究正在进行中，以支持在临床研究中使用DENV-DD。
登革热是由蚊子传播给人类的最常见的病毒感染，每年影响全球约5000万至6000万人。然而,很少有资源来理解和捕捉病人在整个疾病中的登革热经历。大多数研究是基于医疗保健提供者的评估，在评估时间点和评估的体征/症状方面缺乏一致性。“登革热疾病指数报告卡（DII-RC）”被用作创建新的“登革热病毒每日日记（DENV-DD）”的基础，以更好地捕获患者对症状强度和登革热疾病负担的体验。对来自秘鲁和厄瓜多尔的48名最近有症状登革热的幼儿的个人和照顾者进行了访谈，以了解患者在患病期间的经历，并测试患者和照顾者是否理解DENV-DD，并包括所有相关和重要的体征/症状和与健康相关的生活质量影响。作为临床研究的一部分,9名患有活动性登革热感染的个体也每天完成DENV-DD,持续28天。我们发现>70%的患者出现发热,头痛,身体疼痛/疼痛，食欲不振和身体虚弱。DENV-DD指令，问题和回答选项(S)被很好地理解，DENV-DD评估的概念与登革热经验相关。我们的研究增加了对登革热疾病经历的理解，并支持DENV-DD在未来的登革热研究中用作整个疾病持续时间的体征/症状评估。
方法：登革热疾病指数报告卡被用作创建DENV-DD的基础，由患者和观察者报告的结果（PRO/ObsRO）仪器组成。在南美的两个登革热流行社区中，我们对有症状的实验室确诊登革热患儿的个体和照顾者进行了定性联合概念启发和认知汇报访谈.访谈分为两轮，允许DENV-DD修改。还使用来自独立登革热人感染模型（DHIM）的数据对DENV-DD进行了小规模定量评估，以产生DENV-DD完成可行性的早期证据。仪器性能和对疾病过程中体征/症状轨迹的洞察力。
结果：对48名参与者进行了访谈（20名成年人，20名年龄较大的儿童/青少年及其照顾者，8名年幼儿童的看护人)。据报道，发烧持续3-15天的各种体征/症状，头痛,身体疼痛/疼痛，食欲不振,>70%的参与者报告了身体虚弱。DENV-DD说明,项目和反应量表被理解，和项目被认为是相关的不同年龄。DHIM数据支持DENV-DD完成的可行性。
结论：研究结果表明DENV-DD（PRO/ObsRO仪器）在登革热流行人群中的含量有效性。心理测量和文化有效性研究正在进行中，以支持在临床研究中使用DENV-DD。
登革热是由蚊子传播给人类的最常见的病毒感染，每年影响全球约5000万至6000万人。然而,很少有资源来理解和捕捉病人在整个疾病中的登革热经历。大多数研究是基于医疗保健提供者的评估，在评估时间点和评估的体征/症状方面缺乏一致性。“登革热疾病指数报告卡（DII-RC）”被用作创建新的“登革热病毒每日日记（DENV-DD）”的基础，以更好地捕获患者对症状强度和登革热疾病负担的体验。对来自秘鲁和厄瓜多尔的48名最近有症状登革热的幼儿的个人和照顾者进行了访谈，以了解患者在患病期间的经历，并测试患者和照顾者是否理解DENV-DD，并包括所有相关和重要的体征/症状和与健康相关的生活质量影响。作为临床研究的一部分,9名患有活动性登革热感染的个体也每天完成DENV-DD,持续28天。我们发现>70%的患者出现发热,头痛,身体疼痛/疼痛，食欲不振和身体虚弱。DENV-DD指令，问题和回答选项(S)被很好地理解，DENV-DD评估的概念与登革热经验相关。我们的研究增加了对登革热疾病经历的理解，并支持DENV-DD在未来的登革热研究中用作整个疾病持续时间的体征/症状评估。
