Scores that use the worst value of their predictor variables in the first 12-24 h should not be used to compare different units: patients mismanaged in a bad unit will have higher scores than similar patients managed in a good unit, and the bad unit's high mortality rate will be incorrectly attributed to its having sicker patients. PIM is a simple model that is based on only eight explanatory variables collected at the time of admission to intensive care. It is accurate enough to be used to describe the risk of mortality in groups of children.

This paper provides the background, available evidence base, and justification for each step in the resultant guidelines and gives a rationale for their use.

Background This study examined racial/ethnic differences among patients in clinical trial (CT) enrollment, refusal rates, ineligibility, and desire to participate in research within the National Cancer Institute's Community Cancer Centers Program (NCCCP) Clinical Trial Screening and Accrual Log. Methods Data from 4509 log entries were evaluated in this study. Four logistic regression models were run using physical/medical conditions, enrollment into a CT, patient eligible but declined a CT, and no desire to participate in research as dependent variables. Results Age ≥ 65 (OR=1.51, CI: 1.28 -1.79), males (OR=2.28, CI: 1.92 – 2.71), and non-Hispanic black race (OR=1.53, CI: 1.2 – 1.96) were significantly associated with more physical/medical conditions. Age ≥ 65 was significantly associated with lower CT enrollment (OR=0.83, CI: 0.7 - 0.98). Males (OR=0.78, CI: 0.65 -0.94) and a higher grade level score for consent form readability (OR=0.9, CI: 0.83 - 0.97) were significantly associated with lower refusal rates. Consent page length ≥ 20 was significantly associated with lower odds of “no desire to participate in research” among CT decliners (OR=0.75, CI: 0.58 – 0.98). Conclusion : There were no racial/ethnic differences in CT enrollment, refusal rates, or “no desire to participate in research” as the reason given for CT refusal. Higher odds of physical/medical conditions were associated with older age, males, and non-Hispanic blacks. Better management of physical/medical conditions before and during treatment may increase the pool of eligible patients for CTs. Future work should examine the role of co-morbidities, sex, age, and consent form characteristics on CT participation.

Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.