To date, no form of medical or surgical intervention in children with this condition has consistently demonstrated its ability resolve nasal hemorrhage. The role of the otolaryngologist is to control bleeding during major episodes of nasal hemorrhage that do not respond to medical management. These patients usually have remarkable improvement in the frequency and severity of epistaxis in adolescence and then require much less aggressive therapy.
Objectives/Introduction
Clinical trial accrual for oral dysplasia is difficult in the U.S. and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5-37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials.
Methods
For the first trial we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified, screened by examination and biopsy. For the second clinical trial we established a preneoplastic lesions clinic and teaching and communications network with regional oral health care professionals.
Results
Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications and a preneoplastic lesions clinic.
Conclusion
We conclude that significant difficulties resulted from medical record /database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of health care professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.
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