Publication bias in surgery: Implications for informed consent

Background. Patients consenting for pancreas surgery are often quoted an operative risk of 1% to 3% based on the literature. However, these results are often from centers of excellence, and as a result the literature mortality rates may not be representative or generalizable. Methods. A MEDLINE search was performed to identify the major studies of pancreaticoduodenectomy (PD) and total pancreatectomy (TP) over a 6-y period (January 1998-December 2003). To obtain a literature-based mortality rate, we performed a meta-analysis of these published series and compared them with actual in-hospital mortality rates based on a representative 20% sample of hospital data in 37 states (the Nationwide Inpatient Sample). The sample included approximately 8 million patient records per year. Literature versus actual mortality rates were compared for the same 6-y period and stratified by academic versus non-academic medical centers. Results. We identified 16 major studies on PD and TP totaling 3641 patients with an overall mortality rate of 3.2% (range 0%-9.3%). The actual mortality rate based on the Nationwide Inpatient Sample (n = 7604) was 2.4-fold higher than the literature rate (adjusted rate of 7.6% versus 3.2%, P < 0.0001). All literature-based series were published from academic medical centers. By contrast, in the national database, 26.3% of PDs (2003/7604) were performed at nonacademic medical centers with a mortality rate of 11.4% (229/2003). The actual mortality rate at academic medical centers was lower than nonacademic medical centers (6.4% (360/ 5601), P < 0.0001), but still higher than the literature-based rate of 3.2% (P < 0.0001). Conclusions. Mortality rates for pancreatic resections in actual practice are 2.4-fold higher than those reported in the literature. Proper informed consent for surgical procedures should include an accurate description of the risks, using actual local and national mortality rates. (c) 2007 Elsevier Inc. All rights reserved.