PREDICT Study

This multi-institutional study has explored the impact that ear disease, in children ages 6 to 24 months, has on the child and their family in terms of quality of life. This study began in January 2009 and is just wrapping up recruitment (ends April 2012). Using several quality of life instruments, both disease specific and general, the study will meet the Academy’s NIH PROMIS collaboration goals.

BACKGROUND: Approximately 1/3 of 20 million (or 6.6 million) children ages 0-4 in the U.S. that are estimated to have moderate to serious ear disease. Ear infection is one of the most common medical problems in childhood; furthermore, the disease is often recurring (also known as acute otitis media). Much of this suffering could be reduced through better education of physicians about appropriate treatments based on stage/severity of disease and through increased awareness of parents about this medical issue and related quality of life issues. Acute otitis media is the most frequent reason for physician visits, prescription of antibacterial drugs and surgery for children in the developed countries of the world(1). Most children have at least one documented episode of acute otitis media by the age of 3 years, with the incidence peaking between 6 and 11 months of age1.

Quality of life issues are crucial in otolaryngology. There have been controversial studies published on the value of certain treatments, such as ear tubes, on the long-term health progress of a child. What is missing in these studies is that although the child may "catch-up" with peers later and may have no lasting health impact if they forego certain treatments, the child and their family may have gone through years of unnecessary stress on the quality of their lives. The whole patient must be treated as early as possible to reduce the burden of disease. Treatment via ear tubes can alleviate much of this suffering.

The AAO-HNS Foundation feels that the insights gained from a quality of life study on acute otitis media is essential to providing the best care for our young patients. It will also support the National Institutes of Health’s Patient-Reported Outcomes Measurement Information Systems (PROMIS), which seeks to develop ways to measure patient-reported symptoms, such as pain and fatigue, and aspects of health-related quality of life across a wide variety of chronic diseases and conditions. The AAO-HNS Foundation is a PROMIS collaborator.

Expected outcomes as they relate to the care of children with acute otitis media:

• Build the published evidence-base and literature on the quality of life impacts on families of children with ear disease such that children get appropriate treatment and access to care.
• Increase awareness across physicians, payers, employees, and the general public about the impact of ear disease on children and families.
• Educate about preventable outcomes of mis-managed chronic ear disease, such as hearing loss, delayed speech/communication.
• Encourage payers/insurance companies to cover appropriate services for children with ear disease.
• Contribute to happier families and stronger communities through raised awareness and empowerment to request/receive appropriate care.

April 2012 Study Update
The PREDICT study has just closed. We achieved 80% to our target goal of 1,500 records. 3,200 sets of forms were sent out to 23 participating sites. Of those, 2,147 physician forms (67%) and 1,266 patient forms (40%) have been returned to the AAO-HNSF for data entry. The last study audit was just concluded and final reimbursement checks will be issued to the sites the first week of May. AAO-HNSF will be completing data entry during the month of May and then data cleaning and quality of life scores will be generated during the month of June. Washington University will begin data analysis in July.

Congratulations to our top recruiting sites...
1st Place - Coastal Ear, Nose and Throat
2nd Place - Washington University SOM
3rd Place - Boys Town Ear, Nose & Throat Institute       
4th Place - Tots Thru Teens Pediatrics   
5th Place - Fenton Pediatrics         

Participating Sites
• Washington University SOM
• Coastal Ear, Nose and Throat
• Otolaryngology Consultants of Memphis
• Park Nicollett Clinic
• Peyton Manning Children's Hospital ENT Ctr
• Boys Town Ear, Nose & Throat Institute
• ENT & Allergy Associates, LLP
• McKinney ENT
• Commonwealth ENT
• Medical University of South Carolina
• David John Bailey, MD, PA
• Johns Hopkins School of Medicine
• Children's Hospital of Wisconsin
• University of Texas Medical Branch
• Summit Medical Group
• Univ. of Kansas - Pediatric Otolaryngology
• University of Michigan Medical Center
• Chesterfield Pediatrics
• Tots Thru Teens Pediatric
• Pediatric Healthcare Unlimited
• Fenton Pediatrics

Study Publications
Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2010 Aug 22

1 Chenevier D.G., LeLorier J (2005) A Willingness-to-Pay Assessment of Parents’ Preference for Shorter Duration of Treatment of Acute Otitis Media in Children. Pharmacoeconomics. 23(12), 1243-1255

2 Greenberger D, Bilenko N et al. (2003) The burden of Acute Otitis Media on the patient and the family. Eur J Pediatr. 162, 576-581

3 Brouwer C.N.M, Rovers M.M. et al. (2005) The impact of recurrent acute otitis media on the quality of life of children and their caregivers. Clin. Otolaryngol. 30, 258-265

To learn more contact:

Banan Ead, Study Coordinator Washington University, EadB@ent.wustl.edu

Stephanie Jones, Director, Research and Quality, sljones@entnet.org