Model observers intended to predict the diagnostic performance of human observers should account for the effects of both quantum and anatomical noise. We compared the abilities of several visual-search (VS) and scanning Hotelling-type models to account for anatomical noise in a localization receiver operating characteristic (LROC) study involving simulated nuclear medicine images. Our VS observer invoked a two-stage process of search and analysis. The images featured lesions in the prostate and pelvic lymph nodes. Lesion contrast and the geometric resolution and sensitivity of the imaging collimator were the study variables. A set of anthropomorphic mathematical phantoms was imaged with an analytic projector based on eight parallel-hole collimators with different sensitivity and resolution properties. The LROC study was conducted with human observers and the channelized nonprewhitening, channelized Hotelling (CH) and VS model observers. The CH observer was applied in a “background-known-statistically” protocol while the VS observer performed a quasi-background-known-exactly task. Both of these models were applied with and without internal noise in the decision variables. A perceptual search threshold was also tested with the VS observer. The model observers without inefficiencies failed to mimic the average performance trend for the humans. The CH and VS observers with internal noise matched the humans primarily at low collimator sensitivities. With both internal noise and the search threshold, the VS observer attained quantitative agreement with the human observers. Computational efficiency is an important advantage of the VS observer.

Objective: The population representativeness of a clinical study is influenced by how real-world patients qualify for the study. We analyze the representativeness of eligible patients for multiple type 2 diabetes trials and the relationship between representativeness and other trial characteristics. Methods: Sixty-nine study traits available in the electronic health record data for 2034 patients with type 2 diabetes were used to profile the target patients for type 2 diabetes trials. A set of 1691 type 2 diabetes trials was identified from ClinicalTrials.gov, and their population representativeness was calculated using the published Generalizability Index of Study Traits 2.0 metric. The relationships between population representativeness and number of traits and between trial duration and trial metadata were statistically analyzed. A focused analysis with only phase 2 and 3 interventional trials was also conducted. Results: A total of 869 of 1691 trials (51.4%) and 412 of 776 phase 2 and 3 interventional trials (53.1%) had a population representativeness of <5%. The overall representativeness was significantly correlated with the representativeness of the Hba1c criterion. The greater the number of criteria or the shorter the trial, the less the representativeness. Among the trial metadata, phase, recruitment status, and start year were found to have a statistically significant effect on population representativeness. For phase 2 and 3 interventional trials, only start year was significantly associated with representativeness. Conclusions: Our study quantified the representativeness of multiple type 2 diabetes trials. The common low representativeness of type 2 diabetes trials could be attributed to specific study design requirements of trials or safety concerns. Rather than criticizing the low representativeness, we contribute a method for increasing the transparency of the representativeness of clinical trials.