Statistical approach to quality assessment in liver transplantation.

PURPOSE: This study investigated the utility of retrospective two one-sided cumulative sum (CUSUM) charts combined with multivariable regression analysis in liver transplantation for transplant center benchmarking. METHODS: One thousand seven hundred and forty-nine consecutive adult primary liver transplants (January 1, 1983 to December 31, 2012) were analyzed retrospectively with two one-sided CUSUM chart analysis of 90-day mortality. RESULTS: Three eras and two subseries in latest era 3 were identified due to graphically delineated relevant shifts in mean 90-day mortality. Delineation of eras 1, 2, and 3 coincided with relevant changes in allocation policies. CUSUM analysis detected a resurgence of higher mean 90-day mortality in era 3 after results had improved continuously over 25 years. In era 3, two subseries were identified with improving mean 90-day mortality rates from 15.4% in subseries 1 to 8.9% in the following subseries 2. The quantitative influence of independent risk factors on 90-day mortality differed markedly between all identified eras and subseries as assessed with multivariable regression analysis deployed on era-specific subcohorts. CONCLUSION: The assessed methodology is able to identify meaningful center-specific eras and subseries of liver transplantation with striking alterations of the significance and weight of outcome drivers for post-transplant 90-day mortality over time. This warrants the introduction of prospective risk-adjusted two one-sided CUSUM chart analysis into quality management in liver transplantation in Germany with the goal to obtain alarm signals as early as possible.

Prognostic relevance of hematological profile before resection for colorectal liver metastases.

BACKGROUND: Although alterations of hematological profile and especially elevated platelet counts were reported to influence survival in primary colorectal cancer, its prognostic relevance before the surgical treatment of colorectal liver metastases (CLM) is mainly unclear. Therefore, the aim of this study was to analyze the impact of these factors on overall survival following liver resection of CLM. MATERIALS AND METHODS: The surgical treatment of primary CLM between 1994 and 2012 in 983 patients was retrospectively analyzed using univariable and multivariable Cox regression models. RESULTS: In the multivariable analyses, a preoperative anemia was independently associated with inferior overall outcome (P = 0.005, hazard ratio: 1.355). However, with only 2.7% of all cases, an elevation of preoperative platelets was not a frequent finding and no independent impact on survival (P = 0.834). Furthermore, abnormal hemoglobin and platelet values had no impact on rate of surgical revisions due to bleeding complications (P = 0.962 and P = 0.671, respectively), but a potential interaction between abnormal hemoglobin and platelet values and the amount of transfused packed red blood cells (P = 0.004 and P < 0.001, respectively) was observed. CONCLUSIONS: Preoperative anemia is statistically significantly associated with inferior overall survival following resection of CLM and might define a new prognostic marker. Preoperative elevated platelets were not a frequent finding and showed no influence on overall survival.

Risk-adjusted analysis of survival variability among hospitals treating biliary malignancy.

Biliary tract cancer's (BTC) treatment main stone for advanced stages is constituted by chemotherapy. Surgical centralization and physicians' confidence in the use of new technologies and molecular analysis turned out to be of interest and potentially influencing survival. After applying a random-effect model, the relationship between each clinical variable on the main outcome was investigated through multilevel mixed-effects logistic regression. The risk-standardized outcomes were calculated for each centre involved. In the unadjusted cohort the median survival was 8.6 months (95%C.I.: 7.8-9.3) with a 9-month survival rate of 48.3% (95%C.I.: 45.0-51.5). A substantial heterogeneity across hospitals was found (I2: 70.3%). In multilevel mixed effect logistic regression, male, being treated for gallbladder cancer, higher ECOG, increased NLR, CEA and Ca 19.9 and low value of haemoglobin showed to increase the odds for 9-month mortality. The model estimated that the residual variance observed in 9-month mortality was attributable for the 2.6% to the treating hospital. Through a multilevel mixed effect model, average risk-standardized mortality within 9 months was 50.1%. As noticeable, all hospital's risk-standardized mortality falls within 95%C.I., thus all participating centres provided similar outcomes when adjusted for patient case-mix. Heterogenicity between hospital did not affect the outcome in term of overall survival.

Postoperative outcomes associated with surgical care for women in Africa: an international risk-adjusted analysis of prospective observational cohorts.

Background: Improving women's health is a critical component of the sustainable development goals. Although obstetric outcomes in Africa have received significant focus, non-obstetric surgical outcomes for women in Africa remain under-examined. Methods: We did a secondary analysis of the African Surgical Outcomes Study (ASOS) and International Surgical Outcomes Study (ISOS), two 7-day prospective observational cohort studies of outcomes after adult inpatient surgery. This sub-study focuses specifically on the analysis of the female, elective, non-obstetric, non-gynaecological surgical data collected during these two large multicentre studies. The African data from both cohorts are compared with international (non-African) outcomes in a risk-adjusted logistic regression analysis using a generalised linear mixed-effects model. The primary outcome was severe postoperative complications including in-hospital mortality in Africa compared with non-African outcomes. Results: A total of 1698 African participants and 18 449 international participants met the inclusion criteria. The African cohort were younger than the international cohort with a lower preoperative risk profile. Severe complications occurred in 48 (2.9%) of 1671, and 431 (2.3%) of 18 449 patients in the African and international cohorts, respectively, with in-hospital mortality after severe complications of 23/48 (47.9%) in Africa and 78/431 (18.1%) internationally. Women in Africa had an adjusted odds ratio of 2.06 (95% confidence interval, 1.17-3.62; P=0.012) of developing a severe postoperative complication after elective non-obstetric, non-gynaecological surgery, compared with the international cohort. Conclusions: Women in Africa have double the risk adjusted odds of severe postoperative complications (including in-hospital mortality) after elective non-obstetric, non-gynaecological surgery compared with the international incidence.

Fistula risk score-adjusted comparison of postoperative pancreatic fistula following laparoscopic vs open pancreatoduodenectomy.

BACKGROUND: To evaluate a risk-adjusted comparison of clinically relevant postoperative pancreatic fistula POPF (CR-POPF) following laparoscopic pancreatoduodenectomy (LPD) vs open pancreatoduodenectomy (OPD) using the fistula risk score (FRS). METHODS: We retrospectively analyzed 579 patients who underwent LPD (n = 274) or OPD (n = 305) between 2012 and 2019 at two tertiary hospitals. Using the FRS, the risk was stratified into four categories; negligible, low, intermediate and high risk. RESULTS: The median FRS was significantly higher in the LPD than in the OPD group (5.4 ± 1.2 vs 3.9 ± 1.8, P < .001). The overall incidence of CR-POPF in the LPD vs OPD groups were 16.4% vs 17.7% (P = .187). When POPF risks were stratified by FRS, CR-POPF following LPD vs OPD in patients with low risk (0% vs 6.3%, P = .294), intermediate risk (16.1% vs 22.9%, P = .053) and high risk (33.3% vs 27.3%, P = .577) were not significantly different. CONCLUSION: Despite a higher risk score in the LPD group, the CR-POPF was similar following both procedures in the unadjusted and FRS-risk-adjusted comparisons. The CR-POPF was more significantly affected by patient risk factors such as the soft pancreas and small pancreatic duct.