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Pediatric research study in Miami

Messages
10
Location
Florida
Hello everyone. I'm a research intern at the Institute of neuro immune medicine (INIM). I have the wonderful oportunity to work with Dr. Rey and Dr. Klimas, they're both wonderful physicians. We're currently looking for 10 to 17 year olds with a diagnosis of Chronic Fatigue Syndrome (CFS) for a Pediatric Study being conducted by the Centers for Disease Control (CDC) for which we are a participating site.

If you know anyone that could benefit from this please let us know call us to 305-275-5470
Thank you.

The institute has a website. Please visit us at www.nova.edu/nim
 
Last edited:

A.B.

Senior Member
Messages
3,780
What kind of study? Could you provide some more information please?
 
Messages
10
Location
Florida
What kind of study? Could you provide some more information please?

We want to learn more about children and adolescents with chronic fatigue syndrome
(CFS). People with CFS have severe, long-lasting fatigue and may also have many other symptoms that their doctors cannot explain. No studies have compared illness characteristics of CFS in young people in different clinics. This information will also help doctors understand how this illness affects their patients and better help them managing their illness.

This is a section of the informed consent that explains a little what we'd be doing.
Taking part in this study is voluntary. If you and your child choose to join this study, you and your child will be asked to answer questionnaires covering topics such as medical history, fatigue and other symptoms, sleep, mood, and general health about your child. We ask you to help your child complete these questionnaires. We ask that you and your child to complete them about one week before the next visit with your child's CFS doctor, and bring them with you when you visit the doctor.
At the office visit, your doctor will review your child's current health status and current medications. Your child will have a physical exam similar to the exam in his/her usual care. You and your child will also be asked some additional questions about his/her illness at the office visit. In addition, the project coordinator will collect some information from your child's clinical records for this study such as clinical findings and lab results. You and/or your child may find some of the questions in the questionnaires to be personal, sensitive and possibly upsetting. If you and/or your child are concerned about a question, you may choose not to answer it for any reason. We estimate that the questionnaires and interview will not take longer than 2 hours total to complete. However, you and your child may take as much time as you need
 

SOC

Senior Member
Messages
7,849
I saw the flier about this when I was there and talked briefly with Dr K about several research projects. This looked legit to me. I would have enrolled my own child if she was still an adolescent.

It looks like an effort to characterize (in legit patients) the illness as manifested in pediatric patients.

Because it is a CDC study with standard "accepted" questionnaires (which we all love for their clarity, accuracy, and applicability :rolleyes:), there will be obnoxious questions. I appreciate that INIM has clarified that study participants don't have to answer offensive questions.

We need as many clear ME patients in this study as possible. I think that patients are only being selected from the practices of legit ME/CFS docs, but I'm not certain.

@inimresearch, would you ask if the child must be a patient of INIM or other specific doctors, or if any child with a CFS diagnosis can participate?
 

NK17

Senior Member
Messages
592
@inimresearch I think it's comforting to learn directly from a researcher that a few selected ME/Cfs clinic's are part of a multi-sites CDC sponsored study of childrens/adolescents affected by the disease.

I'd like to know, as many other patients I'm sure would like to know, which Consensus Criteria will be used for patient's selection for this specific study and if a part of the questionnaire is regarding Cognitive Functioning.

Thank you ;)
 
Messages
10
Location
Florida
@SOC CDC questionnaires are very thorough, as a matter of fact Dr. Klimas liked the Physical Examination form the CDC provided so much that we implemented it to our regular visits. Any child diagnosed with CFS is able to participate

@NK17 Thank you, I enjoy my work and I Participants will be evaluated for their possible inclusion and verbal assent/parental permission will be obtained over the phone during eligibility screening. Any participant (10 – 17 years of age) managed as or diagnosed with CFS, PIF, or ME in the participating clinic sites is eligible. Exclusions are HIV infection, current pregnancy, or dementia precluding full participation/consent.
 

SOC

Senior Member
Messages
7,849
@SOC CDC questionnaires are very thorough, as a matter of fact Dr. Klimas liked the Physical Examination form the CDC provided so much that we implemented it to our regular visits. Any child diagnosed with CFS is able to participate

@NK17 Thank you, I enjoy my work and I Participants will be evaluated for their possible inclusion and verbal assent/parental permission will be obtained over the phone during eligibility screening. Any participant (10 – 17 years of age) managed as or diagnosed with CFS, PIF, or ME in the participating clinic sites is eligible. Exclusions are HIV infection, current pregnancy, or dementia precluding full participation/consent.

So not any child diagnosed with CFS is allowed to participate. They must be being treated at, or at least diagnosed by one of the participating clinics, right? That makes a big difference to patients because we want to be confident that the patient cohort is properly diagnosed. There are far, far too many people incorrectly diagnosed with CFS by GPs. Poor diagnosis and inclusion of non-ME/CFS patients in research studies has been a huge problem in the past, causing ambiguous and even faulty research results. We like it when research studies require proper diagnosis by expert clinicians. :)
 

NK17

Senior Member
Messages
592
@SOC CDC questionnaires are very thorough, as a matter of fact Dr. Klimas liked the Physical Examination form the CDC provided so much that we implemented it to our regular visits. Any child diagnosed with CFS is able to participate

@NK17 Thank you, I enjoy my work and I Participants will be evaluated for their possible inclusion and verbal assent/parental permission will be obtained over the phone during eligibility screening. Any participant (10 – 17 years of age) managed as or diagnosed with CFS, PIF, or ME in the participating clinic sites is eligible. Exclusions are HIV infection, current pregnancy, or dementia precluding full participation/consent.
Can I ask which are the other participating clinics?
Is the OMI in Mountain View (CA) funded by Dr. Kogelnik part of the clinics?
 

Kati

Patient in training
Messages
5,497
It sounds to me like this is the existing CDC study branching out to include and research children.

They want to see if there are differences in diagnosis between the centers, and it is inclusive of the patients they see, whether they belong to a case definition or not.