A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trials

Jan C Schuller; Michael Mayer; Doris Lanz; Shu-Fang Hsu Schmitz; Peter Brauchli; Nicolas Leupin

doi:10.1016/j.cct.2009.01.010

A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trials

Contemp Clin Trials. 2009 May;30(3):201-4. doi: 10.1016/j.cct.2009.01.010. Epub 2009 Feb 11.

Authors

Jan C Schuller¹, Michael Mayer, Doris Lanz, Shu-Fang Hsu Schmitz, Peter Brauchli, Nicolas Leupin

Affiliation

¹ Swiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland. [email protected]

PMID: 19470310
DOI: 10.1016/j.cct.2009.01.010

Abstract

We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, it is particularly useful for multimodal treatments or a sequence of different therapies where the CONSORT flow chart is less informative and can be confusing.

MeSH terms

Carcinoma, Non-Small-Cell Lung / mortality
Carcinoma, Non-Small-Cell Lung / pathology
Carcinoma, Non-Small-Cell Lung / therapy*
Clinical Trials, Phase II as Topic / methods
Combined Modality Therapy
Disease-Free Survival
Follow-Up Studies
Humans
Leukemia, Lymphocytic, Chronic, B-Cell / mortality
Leukemia, Lymphocytic, Chronic, B-Cell / pathology
Leukemia, Lymphocytic, Chronic, B-Cell / therapy
Lung Neoplasms / mortality
Lung Neoplasms / pathology
Lung Neoplasms / therapy*
Neoplasm Staging
Outcome Assessment, Health Care / methods
Prospective Studies
Randomized Controlled Trials as Topic / methods*
Software
Software Design*