Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators.

AIM: To develop a comprehensive item library of patient-reported, immunotherapy-related adverse events (irAEs) that draws from and expands on the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. METHODS: Literature review and iterative expert input. Based on a literature review of irAEs, we developed a framework of immunotherapy classes and their associated symptoms. Clinical experts then reviewed iterations of symptom summaries and item maps linked to the immunotherapy framework. Experts provided content review and feedback was shared across experts until consensus was reached. The iterative process facilitated creation of a Primary Symptom List associated with immune checkpoint modulators (ICMs), drawn from the larger set of symptoms. Existing FACIT items were mapped to the symptom list, and new items were written as needed to create the item library. RESULTS: The full item library of irAEs is comprised of 239 items, covering 142 unique symptoms across 75 inflammatory reactions/immune conditions. A subset of 66 items comprises a Primary Symptom List considered most common/relevant to ICM treatment. This includes gastrointestinal, skin, pulmonary, neurologic, musculoskeletal, and multiple miscellaneous and constitutional symptoms. CONCLUSION: The FACIT Immunotherapy Item Library is a compilation of 239 self-report items that capture the wide range of AEs experienced by people receiving immune treatments. A subset of 66 items comprises a Primary Symptom List meant for ICM therapy. Use of items selected from this library is encouraged in clinical research and clinical practice evaluation.

Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.

BACKGROUND: Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. AIM: To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors. MATERIALS & METHODS: We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3-6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. RESULTS: The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30-60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. CONCLUSION: Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation.

A community-based assessment of learning disabilities using environmental and contextual risk factors.

Childhood placement in learning disability (LD) programs in the USA has tripled over the last few decades to 6% of all children enrolled in the public schools today. The revision of educational laws to improve LD testing and reporting guidelines has been credited for these trends. However, some researchers also believe that the increase in LD incidence may be due, in part, to chronic low level exposure to toxicants such as lead, heavy metals, solvents and others chemicals in the physical environment. This study employs the use of geo-statistical methods to explore the potential linkages between these pollution sources and the prevalence rates of LD within an urbanized environment, in the USA. The role of contextual factors such as housing quality, poverty, low parental educational achievement, and other disadvantages are also examined. Using primary data on childhood disabilities for 1997, the LD cases were queried and analyzed to identify the spatial clusters within the community. The neighborhoods within the LD clusters were then compared to other areas in the community on the basis of the environmental and contextual risk factors. The results confirmed that areas of high risk for LD were strongly associated with historically significant sources of lead toxicity and air pollution facilities. Among the socio-economic indicators, the high-risk neighborhoods were characterized by multiple/subdivided housing units, poverty, higher percentage of residents on public assistance and lower adult educational attainment. Taken together, these results suggest the need for a more inclusive multi-disciplinary research on LD that extends beyond the classroom context to the neighborhoods and communities in which these children reside.