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Abstract

Preoperative glucocorticoid administration has been proposed for reducing postoperative morbidity. This is not widely used before esophageal resection because of incomplete knowledge regarding its effectiveness. The aim here was to assess the effects of preoperative glucocorticoid administration in adults undergoing esophageal resection for esophageal carcinoma. Studies were identified by searching the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Cancer Lit, SCIELO and Cochrane Library, and by manual searching from relevant articles. The last search for clinical trials for this systematic review was performed in December 2004. This review included randomized studies of patients with potentially resectable carcinomas of the esophagus that compared preoperative glucocorticoid administration with placebo. Data were extracted by the same reviewers, and the trial quality was assessed using Jadad scoring. Relative risk and weighted mean difference with 95% confidence limits were used to assess the significance of the difference between the treatment arms. Four randomized trials involving 146 patients were found. There were no differences in postoperative mortality, sepsis, anastomotic leakage, hepatic and renal failure between the glucocorticoid and placebo groups. There were fewer postoperative respiratory complications (p = 0.005) and multiple postoperative complications (p = 0.004) and lower postoperative plasma interleukin-6 levels (p = 0.00001) with preoperative glucocorticoid administration. There was a higher postoperative PaO2/FiO2 ratio (p = 0.0001) with preoperative glucocorticoid administration. Prophylactic administration of glucocorticoids is associated with decreased postoperative complications.

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Assessing the quality of reports of randomized clinical trials: is blinding necessary?

A. Jadad, R Moore, D. Carroll … (1996)

It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.

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Surgeon volume and operative mortality in the United States.

John Birkmeyer, Therese A Stukel, Andrea Siewers … (2003)

Although the relation between hospital volume and surgical mortality is well established, for most procedures, the relative importance of the experience of the operating surgeon is uncertain. Using information from the national Medicare claims data base for 1998 through 1999, we examined mortality among all 474,108 patients who underwent one of eight cardiovascular procedures or cancer resections. Using nested regression models, we examined the relations between operative mortality and surgeon volume and hospital volume (each in terms of total procedures performed per year), with adjustment for characteristics of the patients and other characteristics of the providers. Surgeon volume was inversely related to operative mortality for all eight procedures (P=0.003 for lung resection, P<0.001 for all other procedures). The adjusted odds ratio for operative death (for patients with a low-volume surgeon vs. those with a high-volume surgeon) varied widely according to the procedure--from 1.24 for lung resection to 3.61 for pancreatic resection. Surgeon volume accounted for a large proportion of the apparent effect of the hospital volume, to an extent that varied according to the procedure: it accounted for 100 percent of the effect for aortic-valve replacement, 57 percent for elective repair of an abdominal aortic aneurysm, 55 percent for pancreatic resection, 49 percent for coronary-artery bypass grafting, 46 percent for esophagectomy, 39 percent for cystectomy, and 24 percent for lung resection. For most procedures, the mortality rate was higher among patients of low-volume surgeons than among those of high-volume surgeons, regardless of the surgical volume of the hospital in which they practiced. For many procedures, the observed associations between hospital volume and operative mortality are largely mediated by surgeon volume. Patients can often improve their chances of survival substantially, even at high-volume hospitals, by selecting surgeons who perform the operations frequently. Copyright 2003 Massachusetts Medical Society