Disclosure of Funding Sources and Conflicts of Interest in Phase III Surgical Trials: Survey of Ten General Surgery Journals

Background

Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI.

Methods

All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures.

Results

From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in “International Committee of Medical Journal Editors (ICMJE)-affiliated journals” did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p < 0.01), statistician/epidemiologist involvement (64.2 vs 43.7 %; p < 0.001), publication after 2008 (52.9 vs 41.1 %; p < 0.01), and the journal being ICMJE-affiliated (49.3 vs 40 %; p < 0.05). Conflict of interest disclosure was associated with publication after 2008 (38.7 vs 11.3 %; p < 0.001), and with the journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001).

Conclusions

Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.     

Neoadjuvant targeted molecular therapies in patients undergoing nephrectomy and inferior vena cava thrombectomy: is it useful?

Objective

To assess the effect of neoadjuvant targeted molecular therapies (TMTs) on size and level of inferior vena cava tumor thrombi and to evaluate their impact on surgical management.

Methods

We retrospectively analyzed the data of 14 patients treated for a clear cell renal cell carcinoma with inferior vena cava thrombi by neoadjuvant TMT before nephrectomy. Clinical, pathological and perioperative data were gathered retrospectively at each institution. The primitive tumor size and the thrombus size were defined by computed tomography before TMT. The tumor thrombus level was defined according to the Novick’s classification.

Results

Before TMT, thrombus level was staged I for 1 (7 %), II for 10 (72 %) and III (21 %) for 3 patients. First-line therapy was sunitinib in 11 cases and sorafenib in 3 cases. Median therapy duration was two cycles (1–5). Three patients experienced major adverse effects (grade III) during TMT. Following TMT, 6 (43 %) patients had a measurable decrease, 6 (43 %) had no change, and 2 (14 %) had an increase in the thrombus. One patient (7 %) had a downstage of thrombus level, 12 (85 %) had stable thrombi, and 1 (7 %) had an upstage. Regarding primary tumor, 7 (50 %), 5 (36 %) and 2 (14 %) patients had a decrease, stabilization and an increase in tumor size, respectively.

Conclusion

Neoadjuvant TMT appears to have limited effects on renal tumor thrombi. This retrospective study failed to demonstrate a significant impact of neoadjuvant TMT on surgical management of clear cell renal cell carcinoma with inferior vena cava tumor thrombi.     

Nephron-sparing surgery is superior to radical nephrectomy in preserving renal function benefit even when expanding indications beyond the traditional 4-cm cutoff

ObjectivesTo analyze to what extent partial nephrectomy (PN) is superior to radical nephrectomy (RN) in preserving renal function outcome in relation to tumor size indication.Methods and materialsClinical data from 973 patients operated at 9 academic institutions were retrospectively analyzed. Glomerular filtration rate (GFR) before and after surgery was calculated with the abbreviated Modification of the Diet in Renal Disease equation. For a fair comparison between the 2 techniques, all imperative indications for PN were excluded. A shift to a less favorable GFR group following surgery was considered clinically significant.ResultsMedian age at diagnosis was 60 years (19–91). Tumor size was smaller than 4 cm in 665 (68.3%) cases and larger than 4 cm in 308 (31.7%) cases. PN and RN were performed in 663 (68.1%) and 310 (31.9%) patients, respectively. In univariate analysis, patients undergoing PN had a smaller risk for developing significant GFR change following surgery than those undergoing RN did. This was true for tumors≤4 cm (P = 0.0001) and for tumors>4 cm (P = 0.0001). In multivariate analysis, the following criteria were independent predictive factors for developing significant postoperative GFR loss: the use of RN (P = 0.0001), preoperative GFR<60 ml/min (P = 0.0001), tumor size≥4 cm (P = 0.0001), and older age at diagnosis (P = 0.0001).ConclusionsThe renal function benefit carried out by elective PN over RN persists even when expanding nephron-sparing surgery indications beyond the traditional 4-cm cutoff.     

Invasive Salmonella enterica Serotype Typhimurium Infections,Democratic Republic of the Congo, 2007–2011

Infection with Salmonella enterica serotype Typhimurium sequence type (ST) 313 is associated with high rates of drug resistance, bloodstream infections, and death. To determine whether ST313 is dominant in the Democratic Republic of the Congo, we studied 180 isolates collected during 2007–2011; 96% belonged to CRISPOL type CT28, which is associated with ST313.     

High Vitamin D Deficiency Rate in Metabolic Inpatients: Is Bariatric Surgery Planning Found Guilty?

Background

High rates of vitamin D insufficiency are usually found in obese patients, even before any malabsorptive bariatric surgery. It is not clear whether they lack vitamin D because of different food intake, different solar exposure, or different storage pathways or bioavailability in adipose tissue. To better understand vitamin D deficiency, we studied different categories of inpatients.

Methods

We collected clinical and biological data from 457 consecutive inpatients during a year: 217 nonobese diabetic patients, 159 obese nonsurgical diabetic patients, 46 obese surgical nondiabetic patients, and 35 obese surgical diabetic patients. Statistically significant differences between two mean 25-hydroxyvitamin D (25(OH)D) levels were defined at the 5 % level using a Z-test.

Results

Vitamin D deficiency was found in 69 % of the patients, while 24 % had a normal level and 7 % an optimal level. A significant difference was found between obese (25(OH)D?=?40.3 nmol/l) and nonobese patients (25(OH)D?=?46.8 nmol/l). Patients undergoing bariatric surgery were not different from the other obese patients.

Conclusion

No significant difference in 25(OH) vitamin D level could be demonstrated between obese patients before bariatric surgery and obese patients with no obesity surgery project. No difference was found between our Parisian obese population and a Spanish obese population, which benefits from a better solar exposure. Both findings suggest that obesity itself is the link with vitamin D deficiency, independently from behavioral differences.     

Placement of multiple and different stent types for very long dissections during coronary angioplasty

We have been investigating the safety and efficacy of multiple and different stent types placed in the unfavorable situation of a very long dissection (>20 mm) after coronary angioplasty. We report our preliminary experience in 20 patients who were treated by the following combinations: Palmaz-Schatz and Micro stent (14 patients); Walistent and Micro stent (4 patients); Wiktor and Micro stent (1 patient); and Palmaz-Schatz, Micro, and Walistent (1 patient). Normal distal flow was restored in all except one (no reflow phenomenon) patient and complete covering of the dissection was obtained in all but two patients. Event-free survival at 30 days was 90% (18 of 20 patients). During follow-up (mean period: 8 ± 3 months), two patients died. Of the 18 other patients, 16 remained asymptomatic and free of complications. Symptomatic restenosis was treated by standard angioplasty in the two remaining patients. In conclusion, placement of different stent types seems a feasible, safe, and efficient treatment for very long dissections caused by standard angioplasty. © 1996 Wiley-Liss, Inc.