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J Thorac Cardiovasc Surg 2004;128:820-822
© 2004 The American Association for Thoracic Surgery
Statistics for the Rest of Us |
a Medical Research Council Biostatistics Unit, Institute of Public Health, Cambridge, United Kingdom
Received for publication February 20, 2004; accepted for publication March 4, 2004.
* Address for reprints David J. Spiegelhalter, PhD, Medical Research Council, Biostatistics Unit, Institute of Public Health, University Forvie Site, Robinson Way, Cambridge CR2 2SR, United Kingdom
david.spiegelhalter@mrc-bsu.cam.ac.uk
| The first 20% of the full text of this article appears below. |
| See related article on pages 807, 811, 823, and 907.
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I am glad to have the opportunity to comment on the article by Rogers and colleagues,1 which contains an excellent discussion of both the potential benefits and hazards of using formal statistical monitoring procedures for clinical data. I particularly welcome the manner in which the authors warn about the possible misinterpretations of the graphs and their recommendation to view multiple complementary charts.
It would be easy to scoff at the growing enthusiasm and spirit of discovery concerning such monitoring procedures, given that Shewhart control charts were being recommended in an industrial context more than 70 years ago,2 and sequential probability ratio tests (SPRT) were developed independently by Wald3 in the United States and Barnard4 in the United Kingdom in the early 1940s. But the recent industrial cumulative sum (CUSUM) literature, for example Hawkins and Olwell,5 shows that many research issues of crucial importance appear to be outstanding, for example, risk adjustment, allowance for overdispersion, multiple systems, and so on. Increased demands for quality assurance in complex medical systems are fueling strong interest in good methodology,6 and previously exotic phrases such as "risk-adjusted CUSUMs" are becoming standard language. This is a particularly exciting period in collaborative research.
My comments concern seven main aspects that need to be considered when designing any monitoring system and focus on what I believe to be currently important issues. The term system is used to imply
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