Tumor response assessment: comparison between unstructured free text reporting in routine clinical workflow and computer-aided evaluation based on RECIST 1.1 criteria.

PURPOSE: Standardized computer-aided tumor response assessment is common in clinical trials. In contrast, unstructured free text reporting (UFTR) is common in daily routine. Therefore, this study aimed to discern and quantify differences between UFTR and computer-aided standardized tumor response evaluation based on RECIST 1.1 criteria (RECIST), serving as gold standard, in clinical workflow. METHODS: One-hundred consecutive patients with cancer eligible for RECIST 1.1 evaluation, who received five follow-up CTs of the trunk, were retrospectively included. All UFTRs were assigned to RECIST response categories [complete response, partial response (PR), stable disease (SD), progressive disease (PD)]. All CTs were re-evaluated using dedicated software (mint lesion™) applying RECIST 1.1. The accordance in tumor response ratings was analyzed using Cohen's kappa. RESULTS: At the first follow-up, 47 cases were rated differently with an SD underrepresentation and a PR and PD overrepresentation in UFTR. In the subsequent follow-ups, categorical differences were seen in 38, 44, 37, and 44%. Accordance between UFTR and RECIST was fair to moderate (Cohen's kappa: 0.356, 0.477, 0.390, 0.475, 0.376; always p < 0.001). Differences were mainly caused by the rating of even small tumor burden changes as PD or PR in UFTR or by comparison to the most recent prior CT scan in UFTR instead of comparison to nadir or baseline. CONCLUSIONS: Significant differences in tumor response ratings were detected comparing UFTR and computer-aided standardized evaluation based on RECIST 1.1. Thus, standardized reporting should be implemented in daily routine workflow.

Assessment of local reaction to vaccines in live piglets with magnetic resonance imaging compared to histopathology.

The safety of veterinary vaccines is assessed in clinical trials in Europe. The assessment of the local tissue reaction to vaccination by magnetic resonance imaging (MRI) could reduce the number of animals needed because repeated examinations can be performed in the same animal over time. The present study compared the evaluation of local tissue reactions to vaccination using MRI in live pigs with histopathology of porcine tissue, the current gold standard in regulatory safety testing. Eight piglets each were administered one of two commercial vaccines into marked injection sites. All animals were sedated and scanned repeatedly by MRI using a contrast agent up to day 29 after vaccination. On day 29, the animals were euthanized and underwent a pathological examination. The MRI results were compared with the pathomorphological findings at the injection site by regression analysis. The MR images and the pathological examinations yielded matching results concerning the sizes of the affected tissue volumes or areas. The use of MRI for regulatory safety testing can reduce the number of animals needed to 8 per examination group. The volume of a local reaction and its progression over time can be evaluated and documented. If persistent lesions develop a final pathomorphological examination is needed to identify the kind and local distribution of the reaction.

Benefit of outpatient cardiac rehabilitation in under-represented patient subgroups.

OBJECTIVE: To assess the effect of outpatient cardiac rehabilitation in important patient subgroups. DESIGN: Prospective cohort study. SUBJECTS: Consecutive patients from March 1999 until July 2003. METHODS: This study assessed the results of symptom-limited bicycle stress testing and health-related quality of life (Profil der Lebensqualität Chronisch Kranker) at baseline and after a 3-month rehabilitation program, and complications and drop-outs during outpatient cardiac rehabilitation. RESULTS: Of 1061 patients, 155 (15%) women, 87 (8%) men aged >or= 75 years, 162 (15%) had diabetes mellitus and 88 (8%) did not speak the local language. Reasons for outpatient cardiac rehabilitation included acute coronary artery disease (87%), valvular heart disease (9%) and congestive heart failure (1%). Mean age was 62 years (standard deviation 11). Patients increased both their age- and body-weight-adjusted workload (p < 0.0001) and quality of life (p < 0.0001) during the program. Although the initial workload achieved was lower than for normal patients (p < 0.0001), it increased in all subgroups during outpatient cardiac rehabilitation (p < 0.0001). Baseline quality of life was lower in women, but increased in most dimensions for all subgroups assessed. CONCLUSION: Important subgroups, such as women, elderly men, diabetic patients and ethnic minorities, are under-represented in outpatient cardiac rehabilitation, although they benefit similarly to other patients. Due to lower baseline quality of life, women may need special medical attention prior to outpatient cardiac rehabilitation.