Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials.

The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation.

Standardization of terminology for episodes of hematopoietic stem cell patient transplant care.

The nomenclature describing hematopoietic stem cell transplantation has evolved, adding precision and definition in research and regulation. The lack of coordination and standardization in terminology has left some gaps in the definition of episodes of clinical care. These voids have caused particular problems in contracting for payment and billing for services rendered. The purpose of this report is to propose definitions for cell products, cell infusions, and transplantation episodes.

A stochastic simulator of a blood product donation environment with demand spikes and supply shocks.

The availability of an adequate blood supply is a critical public health need. An influenza epidemic or another crisis affecting population mobility could create a critical donor shortage, which could profoundly impact blood availability. We developed a simulation model for the blood supply environment in the United States to assess the likely impact on blood availability of factors such as an epidemic. We developed a simulator of a multi-state model with transitions among states. Weekly numbers of blood units donated and needed were generated by negative binomial stochastic processes. The simulator allows exploration of the blood system under certain conditions of supply and demand rates, and can be used for planning purposes to prepare for sudden changes in the public's health. The simulator incorporates three donor groups (first-time, sporadic, and regular), immigration and emigration, deferral period, and adjustment factors for recruitment. We illustrate possible uses of the simulator by specifying input values for an 8-week flu epidemic, resulting in a moderate supply shock and demand spike (for example, from postponed elective surgeries), and different recruitment strategies. The input values are based in part on data from a regional blood center of the American Red Cross during 1996-2005. Our results from these scenarios suggest that the key to alleviating deficit effects of a system shock may be appropriate timing and duration of recruitment efforts, in turn depending critically on anticipating shocks and rapidly implementing recruitment efforts.

Effect of information availability on assessment and designation of species at risk.

Information required to evaluate the extent to which species are at risk of extinction is usually limited and characterized as highly uncertain. In this context, we define information availability as the presence or absence of information used to determine the value of an ecological variable. We examined which of three hypothetical approaches best matched how levels of risk are assigned to species: (1) precautionary approach in which analysts designate levels of risk regardless of the amount of information available, (2) worst-case approach in which analysts assign the maximum level of risk possible from the criteria, and (3) insurance approach in which analysts assign poorly known species to a high-risk category when little information is available. We used the quantitative assessment criteria of the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) as a case study. We created a binary (0/1) matrix of all 2.4192 × 10(7) logical combinations of available information for the 14 ecological variables included in the quantitative criteria. We processed each combination of information availability represented in the matrix with a computer algorithm designed to emulate COSEWIC decision-making rules. Low information availability was associated with a relatively high frequency of not being able to assign a candidate taxon to a risk category, which does not follow the precautionary principle. Information availability and the level of risk assigned to species were directly related, which is associated with the worst-case approach, and counter to the insurance approach. Our results suggest that information availability can have a major effect on the level of risk assigned to a species. We recommend a conscious determination of whether such effects are desired, and we recommend the development of methods to explicitly characterize and incorporate information availability and other sources of uncertainty in decision-making processes.