UPDATE

Number 1 February 1996

TALKING FEVER

by: Bob Pantell, MD, Febrile Infant Study Principal Investigator
R. "Mort" Wasserman, MD, PROS Director

Welcome to the first issue of the Febrile Infant Study Update! Since the Febrile Infant Study (FIS) is the first PROS study designed to run at a "background level" over a period of more than a year, we have decided to use a newsletter to keep in touch with PROS participants in the study.

What does "running at a background level" mean? For most practitioners, seeing a febrile infant less than or equal to 3 months of age in the office is a relatively infrequent experience. Since data collection is required only when a very young febrile infant is seen, the FIS has a very low day-to-day impact on office practice. The low imposition on practice activities is a positive feature of the FIS, but it brings its own set of challenges.

The principal challenge, in light of the fact that weeks or months may go by between febrile infants of the appropriate age, is for you and your office staff to remember to enroll all of the eligible patients when they come into the office. This is important for two reasons. First, the more subjects are missed, the longer it will take to accumulate the thousands of subjects needed to give the study sufficient statistical power. Second, if only certain types of very young febrile infants are enrolled (e.g., those with a milder clinical picture), then the study runs the risk of a selection bias that could distort the results.

What is the best way to assure enrollment of all eligible subjects? As is always the case in practice-based research, each office will need to figure out its own best strategies. We suggest that each practice take a few moments in a practice meeting to discuss practical solutions. PROS would like to hear what these solutions are and will publish them in a future Febrile Infant Study Update (send to Fever Study Research Assistant c/o PROS at the AAP -- phone 800/433-9016, ext. 7620, fax 847/228-9651, or e-mail pros@aap.org). In the meantime we have enclosed a copy of a FIS reminder card, including the study's logo (a thermometer -- what else?) to each participant to post in a prominent place.

Once again, we thank you for your participation in this landmark study. Through your efforts on this project, PROS practitioners will answer the question of how best to manage very young febrile infants.

Patient Enrollment Update (Total
Sample Size at End of Each Quarter)

For a variety of reasons (e.g., competing PROS studies, seasonal low case incidence, delayed practice start-ups), patient enrollment in the Febrile Infant Study began slowly in 1995. Recent case enrollments have picked up notably, with >20 cases per week being enrolled network-wide. Enrollment needs to continue to accelerate in order for the Febrile Infant Study to meet its goal. For this reason, we are counting on each PROS practitioner who has agreed to collect data in the Febrile Infant Study to enroll each febrile infant <3 months of age that s/he sees.

QUESTIONS?

Please call PROS Central or UCSF with any questions you may have!
800/433-9016 X7620
800/468-7803


Core support for the PROS network is provided by a grant from the Health Resources and Services Administration Maternal and Child Health Bureau

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Pediatric Research in Office Settings (PROS)
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141 Northwest Point Blvd
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800/433-9016, ext. 7623