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CRS Questionnaire Validation Project

This important study aims to test if two new questionnaires are good at understanding how people with ongoing sinus problems (Chronic Rhinosinusitis, with or without lumps called nasal polyps) feel about their symptoms and how well they are managed. Researchers from 32 medical centres in Europe, the USA, and South Africa are working together on this project. They need to recruit 1000 patients in total. The goal is to make sure these questionnaires accurately reflect a patient's daily experience, which can help doctors better understand and manage the condition in the future. The study involves collecting information from patients during their routine clinic visits, making participation as straightforward as possible.

At a glance

Status
Recruiting
Sponsor
The European Forum for Research and Education in Allergy and Airway Diseases
Enrolment target
1,000
Start
01 Sep 2024
Estimated completion
30 Sep 2026

What is this study about?

Imagine you have ongoing sinus problems, sometimes called Chronic Rhinosinusitis (CRS). It can be tricky for doctors to understand exactly how much it affects your daily life and how well your current treatment is working, based on just a quick chat. This study is all about making that process better, for you and for future patients.

Researchers are testing two new questionnaires. Think of these as special forms designed to help you describe how severe your CRS symptoms are and how well you feel your condition is under control. The aim is to see if these new questionnaires really do a good job of capturing your experience, much like a thermometer accurately measures temperature. If they work well, these questionnaires could become really useful tools for doctors in their everyday practice.

Doctors and medical centres across many different countries, including Europe, the USA, and South Africa, are working together on this project. They want to make sure the questionnaires are accurate and reliable for a wide range of people. They will compare the results from these new questionnaires with other ways doctors currently check on CRS, to ensure the new tools are as good, or even better. This study is a big step towards improving how we understand and manage chronic sinus problems.

Key takeaways

  • This study tests new questionnaires for chronic sinus problems.
  • It aims to improve how doctors understand your symptoms and control.
  • Participation involves filling out forms during a regular clinic visit.
  • No new treatments or medications are given.
  • You help improve care for future patients with sinus issues.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) and agree to take part, meaning you understand what the study involves and confirm your willingness to participate. A doctor would need to have diagnosed you with chronic rhinosinusitis, which might include having nasal polyps, following specific medical guidelines.

There are a few reasons why you might not be able to join. For example, if you've had sinus surgery in the last three months, you wouldn't be able to participate. Also, if a doctor determines that you don't actually have chronic rhinosinusitis, or if you're unable to provide your consent to join, then this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with chronic rhinosinusitis (with or without nasal polyps)?
  3. Have you had sinus surgery in the last three months? (If yes, you may not be eligible.)
  4. Are you able to understand the study and agree to take part?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need any extra visits beyond your usual appointments with your ear, nose, and throat (ENT) doctor. During one of your regular clinic visits, you would be asked to complete the two new questionnaires. This involves answering questions about how you feel your chronic sinus problem is affecting you, including how severe your symptoms are and how well you feel the condition is controlled. The study aims to make your involvement as simple as possible by fitting into your existing care plan. There are no medications or special treatments involved in this study. The questionnaires are usually quite quick to fill out, and that would be your main task as a participant.

Potential risks and benefits

A potential benefit of taking part in this study is contributing to better understanding and management of chronic sinus conditions for future patients, as well as helping to develop more patient-focused tools for doctors. There are very few risks involved, as you are simply filling out questionnaires during a regular clinic visit with no new treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (32)

  • UCLA Santa Monica Medical Center
    Verified postcode
    Santa Monica, United States· Recruiting
  • Northwestern University Feinberg School of Medicine
    Verified postcode
    Chicago, United States· Recruiting
  • Brigham Sinus Center at Brigham and Women's Hospital
    Verified postcode
    Boston, United States· Recruiting
  • Thomas Jefferson University Hospital
    Verified postcode
    Philadelphia, United States· Recruiting
  • Eastern Virginia Medical School
    Verified postcode
    Virginia City, United States· Recruiting
  • UZ Gent
    Verified postcode
    Ghent, Belgium· Not yet recruiting
  • UZ Leuven
    Verified postcode
    Leuven, Belgium· Recruiting
  • St. Michael's Hospital
    Verified postcode
    Toronto, Canada· Recruiting
  • Univ of Copenhagen
    Verified postcode
    Copenhagen, Denmark· Recruiting
  • HNO-Klinik, Universitätsklinikum Düsseldorf
    Verified postcode
    Düsseldorf, Germany· Not yet recruiting
  • Univ Munich
    Verified postcode
    Munich, Germany· Not yet recruiting
  • University General Hospital of Heraklion
    Verified postcode
    Heraklion, Greece· Recruiting

Common questions

What is Chronic Rhinosinusitis (CRS)?

It's a long-lasting condition where the lining of your nose and sinuses becomes inflamed for an extended period, often leading to symptoms like a blocked nose, face pain, and reduced sense of smell.

What are nasal polyps?

Nasal polyps are soft, painless, non-cancerous growths inside your nose or sinuses, often linked with chronic rhinosinusitis.

Why is this study important?

This study is important because it helps test new tools (questionnaires) that could allow doctors to better understand how your chronic sinus problems affect you, leading to improved care.

Will I receive new treatment?

No, this study does not involve any new treatments or medications. You will only be asked to complete questionnaires during a regular clinic visit.

How long will I be in the study?

Your participation in the study involves completing questionnaires during one of your routine clinic visits. It will not extend beyond that single data collection point.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "CRS Questionnaire Validation Project…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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