Patient Participation, PROM
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALReflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Sponsors
Northwestern University
Medical University of South Carolina
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Patients will be assigned randomly to complete one of six patient reported outcome measures. Prior to completion of the patient reported outcome measures, patients will be randomly assigned to one of three groups: Group A where patients will be asked to reflect on positive health-related experiences, Group B where patients will be asked to reflect on negative health-related experiences, Group C where patients will not be asked to reflect on health-related experiences (Control).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
18 years of age and older, living in the US, fluent written and spoken English, able to consent
Exclusion criteria
Any criteria that does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 score | 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. |
| EQ-5D-5L score | 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. |
| PROMIS Global health v1.2 score | 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. |
| mini-RQLQ score | 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. |
| Sinonasal Outcomes Test (SNOT)-22 score | 15 minutes | For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome. |
| Rhinosinusitis Disability Index (RSDI) score | 15 minutes | For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Present Mood Visual Analogue Scale | 15 minutes | 10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome |
Countries
United States
Outcome results
None listed