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Gonadal hypofunction is described in male and female patients with sickle cell anemia (SCA) after bone marrow transplant (BMT) and in males treated with hydroxyurea (HU). Anti-Müllerian hormone (AMH) is a serum marker of ovarian reserve. This study describes AMH and follicle-stimulating hormone (FSH) levels in female SCA subjects treated with supportive care (SCA-SC), HU (SCA-HU) and BMT (SCA-BMT). SCA (SS/Sβ(0)) subjects not on HU, on HU and status-post BMT, ages 10-21 years were recruited. SCA-HU subjects were treated with HU ≥ 20 mg/kg for ≥ 12 consecutive months. SCA-BMT subjects had received busulfan and cyclophosphamide. Serum AMH and random FSH levels were obtained. Diminished ovarian reserve (DOR) was defined as AMH level5th percentile for age-matched controls. Subjects also with FSH40 IU/L were classified as having premature ovarian insufficiency (POI). 14 SCA-SC (14.5 ± 2.7 years), 33 SCA-HU (14.4 ± 2.4 years) and 9 SCA-BMT (14.3 ± 2.7 years) females were included. AMH was undetectable in all SCA-BMT subjects and5th percentile in 24% of SCA-HU subjects. FSH was menopausal (40 IU/L) in 88.9% of SCA-BMT subjects. All SCA-BMT subjects and 24% of subjects on HU had DOR; 89% of SCA-BMT subjects had POI. AMH and FSH may be useful tools in assessing ovarian reserve and function.

Cancer SurvivorLinkTM, www.cancersurvivorlink.org , is a patient-controlled communication tool where survivors can electronically store and share documents with healthcare providers. Functionally, SurvivorLink serves as an electronic personal health record—a record of health-related information managed and controlled by the survivor. Recruitment methods to increase registration and the characteristics of registrants who completed each step of using SurvivorLink are described. Pediatric cancer survivors were recruited via mailings, survivor clinic, and community events. Recruitment method and Aflac Survivor Clinic attendance was determined for each registrant. Registration date, registrant type (parent vs. survivor), zip code, creation of a personal health record in SurvivorLink, storage of documents, and document sharing were measured. Logistic regression was used to determine the characteristics that predicted creation of a health record and storage of documents. To date, 275 survivors/parents have completed registration: 63 were recruited via mailing, 99 from clinic, 56 from community events, and 57 via other methods. Overall, 66.9 % registrants created a personal health record and 45.7 % of those stored a health document. There were no significant predictors for creating a personal health record. Attending a survivor clinic was the strongest predictor of document storage (p

To develop a model of shared healthcare delivery that includes primary care providers (PCP) and ensures best practice in follow-up of pediatric cancer survivors.Structured interviews with healthcare professionals (HCPs) were used to ascertain familiarity and confidence in providing care to survivors. Partnerships were made with HCP societies, and survivor care lectures were given at HCP meetings. HCP's preferences for ongoing continuing education (CE) opportunities were ascertained. Cancer SurvivorLink(TM), a web-based tool, was developed to allow patients to securely store their healthcare documents and share them electronically with registered HCPs. Educational material developed for Cancer SurvivorLink(TM) includes CE modules and QuickFacts--concise summaries of late effects. Website utilization was monitored utilizing Google Analytics.HCPs described moderate to very low familiarity with survivor care, but high interest in online CE learning. Thirty-one lectures were given to HCP groups to increase awareness. Preferred types of ongoing CE were: lectures, online text, and video modules. CE material was developed based on feedback from HCPs and website utilizations and includes 19 QuickFacts and 5 CE modules. During the first year, the website had 471 unique visitors and 1,129 total visits. QuickFacts received 345 views with Neurocognitive, Survivor Care 101, and Endocrine being most visited, and 49 CME modules have been completed.PCPs are interested in partnering in models of shared care for pediatric cancer survivors. Effective educational initiatives include lectures within HCP's professional education constructs and web-based CE opportunities. PCP involvement in survivor care alleviates some barriers to care such as geographic distance to the the cancer center and ensures that more pediatric cancer survivors receive recommended coordinated surveillance for late effects of cancer therapy.

Subject retention and adherence are essential to maintain the power and validity of the Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG). We designed a study to assess adherence with study medication administration and study visits and to evaluate socioeconomic factors (SES) that may influence these measurements of adherence. These data are important for assessing impact of adherence on BABY HUG trial outcome and defining impact of SES on adherence.Each subject's median study medication (MedAd) and mean visit adherence (VAd) were evaluated. We examined associations of adherence with SES of participating families.MedAd data were available on 153 of the 191 subjects who started randomized study medication. MedAd was 101.7% of volume prescribed, with 88.9% of subjects taking at least 80% of doses. VAd data were available on 185 of the 191 subjects who started randomized study medication. VAd was 97.3%, with 82.2% of subjects having no missed visits. During dose titration, subjects had on average 12.9% higher medication adherence than subjects who were on a stable dose and had less frequent study visits. MedAd and VAd were not significantly associated with SES.Subjects in the BABY HUG trial have had excellent adherence. SES was not associated with adherence, suggesting that SES should not be used as a criterion for enrolment in clinical trials. Additional efforts are needed to maintain medication adherence, particularly when the interval between scheduled visits increases. (ClinicalTrials.gov number, NCT00006400).

BABY HUG (NCT00006400) is an NHLBI-NICHD sponsored Phase III multi-center, randomized, double blind placebo controlled study of daily oral hydroxyurea in infants 9–17 months of age with sickle cell anemia. Subject retention and adherence are essential to maintain the power and validity of the trial. Initially, we hypothesized that families with higher socioeconomic status (SES) and advanced education would be better able to comply with the complex study procedures. We evaluated SES and other demographic factors which may influence adherence in the ongoing study. Both study drug adherence and visit adherence were examined. Study visits occurred every two weeks until a stable dose was reached and then every four weeks unless toxicity was encountered. Subjects remained on study for two years. Study drug adherence was monitored by measuring liquid in returned bottles at each visit. Bottles were included in the analysis if the subject was dispensed a bottle at a visit, returned it at the next scheduled visit with a non-zero volume, and did not have a drug stop order between the visits. From these bottles, each subject’s median drug adherence was calculated. Drug adherence (%) was defined as the amount consumed divided by the amount which should have been consumed. Visit adherence (%) was based on expected routine study visits. Subjects were withdrawn from the study upon family request or if they continually missed visits. We defined ‘good adherence’ as taking ≥80% study drug and attending ≥90% study visits. Adherence data was available on 186 of the 193 randomized infants. The median drug adherence was 101.7%, with 88.9% of subjects having drug adherence of ≥80%, and three infants having drug adherence >150%. The mean visit adherence was 97.3% ± 8.4 SD, with 82.3 % of subjects having no missed visits. Thirteen infants had a visit adherence of