Inclusion and exclusion criteria with rationale
| Criteria* . | Rationale . |
|---|---|
| Inclusion | |
| Diagnosis of ALL at <21 y of age, in first remission | The study aimed to explore the underlying causes of racial differences in outcomes in children with ALL diagnosed at <21 y of age. |
| This age cutoff was used because the current study was attempting to understand the causes of racial differences in survival that had been observed by us and others in previous studies that had also used age at diagnosis of 21 y as the cutoff. | |
| Belongs to the following self-reported racial categories: non-Hispanic white, African American, or Asian American† | The study aimed to explore the prevalence and predictors of nonadherence in children from these three racial groups. |
| Has completed the first 6 mo block of maintenance therapy for ALL | This allows patients to become accustomed to the routine of maintenance therapy. It also increases the probability that >90 d have elapsed since last red cell transfusion, avoiding contamination of TGN and TPMT activity by transfusion (the majority of transfusions administered during maintenance therapy are within the first 6 mo). |
| ≥6 mo of maintenance therapy remain at enrollment | The last 6-mo block of maintenance therapy is needed to ensure adequate time for adherence monitoring during study enrollment. |
| Receiving oral 6MP during maintenance therapy for ALL | The study is designed to measure adherence to oral 6MP. |
| Signed assent/consent by the patient/parent | To ensure that all human subjects’ protection issues are addressed. |
| Exclusion | |
| Patients of multiethnic/multiracial backgrounds | The study aimed to explore systemic exposure to 6MP among patients belonging to the 3 self-reported racial groups: Non-Hispanic white, Asian American, African American. Patients of multiethnic/racial backgrounds were not included in this study; this will be the focus of future study. |
| Patients of Hispanic ethnicity | A study with the same study design has reported the adherence to oral 6MP among Hispanics. |
| Patients who are unable to use MEMS TrackCap (eg, using pillbox or liquid 6MP) | MEMS TrackCap was the primary method of assessing adherence; use of a pillbox or liquid 6MP would have prevented the use of MEMS TrackCap. |
| Criteria* . | Rationale . |
|---|---|
| Inclusion | |
| Diagnosis of ALL at <21 y of age, in first remission | The study aimed to explore the underlying causes of racial differences in outcomes in children with ALL diagnosed at <21 y of age. |
| This age cutoff was used because the current study was attempting to understand the causes of racial differences in survival that had been observed by us and others in previous studies that had also used age at diagnosis of 21 y as the cutoff. | |
| Belongs to the following self-reported racial categories: non-Hispanic white, African American, or Asian American† | The study aimed to explore the prevalence and predictors of nonadherence in children from these three racial groups. |
| Has completed the first 6 mo block of maintenance therapy for ALL | This allows patients to become accustomed to the routine of maintenance therapy. It also increases the probability that >90 d have elapsed since last red cell transfusion, avoiding contamination of TGN and TPMT activity by transfusion (the majority of transfusions administered during maintenance therapy are within the first 6 mo). |
| ≥6 mo of maintenance therapy remain at enrollment | The last 6-mo block of maintenance therapy is needed to ensure adequate time for adherence monitoring during study enrollment. |
| Receiving oral 6MP during maintenance therapy for ALL | The study is designed to measure adherence to oral 6MP. |
| Signed assent/consent by the patient/parent | To ensure that all human subjects’ protection issues are addressed. |
| Exclusion | |
| Patients of multiethnic/multiracial backgrounds | The study aimed to explore systemic exposure to 6MP among patients belonging to the 3 self-reported racial groups: Non-Hispanic white, Asian American, African American. Patients of multiethnic/racial backgrounds were not included in this study; this will be the focus of future study. |
| Patients of Hispanic ethnicity | A study with the same study design has reported the adherence to oral 6MP among Hispanics. |
| Patients who are unable to use MEMS TrackCap (eg, using pillbox or liquid 6MP) | MEMS TrackCap was the primary method of assessing adherence; use of a pillbox or liquid 6MP would have prevented the use of MEMS TrackCap. |
Eligibility is not affected by the patient or parent/caregiver’s ability to speak English.
Racial categories: non-Hispanic white: European, North African, or Middle Eastern ancestry; Asian Americans: Asian Indian subcontinent, Chinese, Japanese, Korean, Native Hawaiian, Guamanian or Chamorro, Pacific Islander, Filipino, Vietnamese, Samoan, Hmong, Cambodian, Thai, Laotian, or other Asian-American races; African Americans: African American or of sub-Saharan black African ancestry.