Study of Kids Itch Severity (SKIS): "Validation and Mobilization of Pediatric Pruritus Outcome Instruments"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- ItchyQoL (KidsItchyQoL) test-retest reliability
研究概览
简要总结
This purpose of this study is to validate two measures of chronic itching in kids: itch severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).
详细描述
There are many diseases that affect children where the primary symptom is pruritus. This study aims to validate an age appropriate pediatric version of the ItchyQoL, a pruritus-specific quality of life instrument, and the ItchyQuant, a self-reported itch severity scale, to better understand how pruritus affects the pediatric population. These instruments will comprehensively capture the severity and impact of pruritus in children. The physicians want to explore the opportunity to integrate patient-reported outcome measures (PROM) as a patient-reported tool in the ambulatory setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients between the ages of 4 and 17 (parents and clinicians will be older than 18 years, both male and female)
- •Informed consent/assent signed and dated by the patient/parent
- •Willingness and ability for the patient to commit to all follow-up visits/phone calls for the duration of the study
排除标准
- •Inability to speak or read English
- •Any other disabilities that would prevent them from completing a survey
- •Unwillingness or inability for the patient to commit to all follow-up visits/phone calls for the duration of the study
结局指标
主要结局
ItchyQoL (KidsItchyQoL) test-retest reliability
时间窗: 6 months
Subjects in the 8-17 year age group will complete the KidsItchyQoL® questionnaire. This is a 27-item questionnaire where the subjects are asked to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.
ItchyQoL (KidsItchyQoL) validity
时间窗: 6 months
Subjects in the 8-17 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.
ItchyQoL (TotsItchyQoL) test-retest reliability
时间窗: 6 months
Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. This questionnaire has a total of 16 items with cartoons accompanying each question. The interviewer will ask the subjects questions to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.
ItchyQoL (TotsItchyQoL) validity
时间窗: 6 months
Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.
Psychometric properties of the ItchyQuant
时间窗: 2 weeks
Age-appropriate ItchyQuant will be administered as follows; subjects 4-5 years will use the modified 3-point ItchyQuant, for subjects 6-7 years, the 3-point and 5-point ItchyQuant and for ages 8 and older, the traditional non-cartoon version of the numeric rating scale (NRS) will be administered. The parent and clinician will also be asked to rate their perceived itch severity on a full-cartoon version of the ItchyQuant. The ItchyQuant is a 10-point numeric rating scale to rate itch severity. The items are scored from 0-10, where 0=no itch and 10= worst imaginable itch. The validity of the ItchyQuant will be assessed by comparing the responses.
次要结局
- Prevalence of ADHD symptoms(2 weeks)
- Feasibility of harnessing an electronic platform as assessed by researcher judgement(1 year from baseline)
研究者
Suephy Chen, MD
Associate Professor
Emory University