Priming and Patient Reported Outcome Measures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Priming Subjects to Influence Responses to Patient Reported Outcome Measures

Conditions
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Patient Participation, PROM

Intervention / Treatment
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* Behavioral: Reflection on health-related experiences


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive health-related experiences and EQ-5D-5L<br>Reflecting on positive health-related experiences EQ-5D-5L questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| Experimental: Negative health-related experiences and EQ-5D-5L<br>Reflecting on negative health-related experiences EQ-5D-5L questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| No Intervention: Control and EQ-5D-5L<br>No intervention/ control group EQ-5D-5L questionnaire | |
| Experimental: Positive health-related experiences and PROMIS<br>Reflecting on positive health-related experiences PROMIS Global health v1.2 questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| Experimental: Negative health-related experiences and PROMIS<br>Reflecting on negative health-related experiences PROMIS Global health v1.2 questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| No Intervention: Control and PROMIS<br>No intervention/ control group PROMIS Global health v1.2 questionnaire | |
| Experimental: Positive health-related experiences and SF-36<br>Reflecting on positive health-related experiences SF-36 questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| Experimental: Negative health-related experiences and SF-36<br>Reflecting on negative health-related experiences SF-36 questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| No Intervention: Control and SF-36<br>No intervention/ control group SF-36 questionnaire | |
| Experimental: Positive health-related experiences and SNOT-22<br>Reflecting on positive health-related experiences SNOT-22 questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| Experimental: Negative health-related experiences and SNOT-22<br>Reflecting on negative health-related experiences SNOT-22 questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| No Intervention: Control and SNOT-22<br>No intervention/ control group SNOT-22 questionnaire | |
| Experimental: Positive health-related experiences and RSDI<br>Reflecting on positive health-related experiences RSDI questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| Experimental: Negative health-related experiences and RSDI<br>Reflecting on negative health-related experiences RSDI questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| No Intervention: Control and RSDI<br>No intervention/ control group RSDI questionnaire | |
| Experimental: Positive health-related experiences and mini-RQLQ<br>Reflecting on positive health-related experiences Mini-RQLQ questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| Experimental: Negative health-related experiences and mini-RQLQ<br>Reflecting on negative health-related experiences Mini-RQLQ questionnaire | Behavioral: Reflection on health-related experiences<br>* This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.<br>|
| No Intervention: Control and mini-RQLQ<br>No intervention/ control group Mini-RQLQ questionnaire | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L score | 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. | 15 minutes | 
| PROMIS Global health v1.2 score | 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. | 15 minutes | 
| SF-36 score | 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. | 15 minutes | 
| Sinonasal Outcomes Test (SNOT)-22 score | For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome. | 15 minutes | 
| Rhinosinusitis Disability Index (RSDI) score | For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome. | 15 minutes | 
| mini-RQLQ score | 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. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Present Mood Visual Analogue Scale | 10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome | 15 minutes |