Priming Subjects to Influence Responses to Patient Reported Outcome Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- mini-RQLQ score
研究概览
简要总结
The objective of the study is to assess which health-related questionnaire is the most accurate and reliable.
The hypothesis is that some health-related questionnaires are more reliable than others.
详细描述
The objective of the study is to test the reliability of patient reported outcome measures, and their robustness to patient-related factors.
Patients will be randomly assigned to complete 1 of 6 patient reported outcome measures. Patients will either be asked to reflect on health-related experiences or not prior to completion of the questionnaire. Basic non-identifiable demographic information, and a brief medical questionnaire will follow completion of the patient reported outcome measure.
Results from each individual patient reported outcome measure will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants are masked from knowing the purpose of the study's hypothesis, which is that patient-related factors may influence scores of patient related outcome measures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older, living in the US, fluent written and spoken English, able to consent
排除标准
- •Any criteria that does not meet the inclusion criteria
研究组 & 干预措施
Negative health-related experiences and mini-RQLQ
Reflecting on negative health-related experiences Mini-RQLQ questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Control and mini-RQLQ
No intervention/ control group Mini-RQLQ questionnaire
Positive health-related experiences and PROMIS
Reflecting on positive health-related experiences PROMIS Global health v1.2 questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Negative health-related experiences and PROMIS
Reflecting on negative health-related experiences PROMIS Global health v1.2 questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Control and PROMIS
No intervention/ control group PROMIS Global health v1.2 questionnaire
Positive health-related experiences and SF-36
Reflecting on positive health-related experiences SF-36 questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Negative health-related experiences and SF-36
Reflecting on negative health-related experiences SF-36 questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Control and SF-36
No intervention/ control group SF-36 questionnaire
Positive health-related experiences and SNOT-22
Reflecting on positive health-related experiences SNOT-22 questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Negative health-related experiences and SNOT-22
Reflecting on negative health-related experiences SNOT-22 questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Control and SNOT-22
No intervention/ control group SNOT-22 questionnaire
Positive health-related experiences and RSDI
Reflecting on positive health-related experiences RSDI questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Negative health-related experiences and RSDI
Reflecting on negative health-related experiences RSDI questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Control and RSDI
No intervention/ control group RSDI questionnaire
Positive health-related experiences and mini-RQLQ
Reflecting on positive health-related experiences Mini-RQLQ questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Positive health-related experiences and EQ-5D-5L
Reflecting on positive health-related experiences EQ-5D-5L questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Negative health-related experiences and EQ-5D-5L
Reflecting on negative health-related experiences EQ-5D-5L questionnaire
干预措施: Reflection on health-related experiences (Behavioral)
Control and EQ-5D-5L
No intervention/ control group EQ-5D-5L questionnaire
结局指标
主要结局
mini-RQLQ score
时间窗: 15 minutes
For the mini-RQLQ, a score 0 to 18 is calculated for the activities domain, 0 to 12 for the practical problems domain, 0 to 18 for the nose symptoms domain, 0 to 18 for the eye symptoms domain, and 0 to 18 for the other symptoms domain. A higher score represents a worse outcome.
EQ-5D-5L score
时间窗: 15 minutes
For the EQ-5D-5L, a scale of 1 to 5 with descriptors is used to score the domains of mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A higher score represents a worse outcome.
Rhinosinusitis Disability Index (RSDI) score
时间窗: 15 minutes
For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome.
SF-36 score
时间窗: 15 minutes
For the SF-36, a score of 0 to 100 is calculated for the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well-being, social functioning, pain, and general health. A higher score represents a more favorable outcome.
Sinonasal Outcomes Test (SNOT)-22 score
时间窗: 15 minutes
For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome.
PROMIS Global health v1.2 score
时间窗: 15 minutes
For the PROMIS Global Health v1.2, a score of 4 to 20 is calculated for the global physical health domain, and a score of 4 to 20 is calculated for the global mental health domain. A higher score represents a worse outcome.
次要结局
- Present Mood Visual Analogue Scale(15 minutes)