Publications by authors named "Vito Laterza"

15 Publications

  • Page 1 of 1

Pancreaticoduodenectomy in octogenarians: The importance of "biological age" on clinical outcomes.

Surg Oncol 2021 Nov 24;40:101688. Epub 2021 Nov 24.

Gemelli Pancreatic Center, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Largo Agostino Gemelli, 8, 00168, Rome, Italy; CRMPG (Advanced Pancreatic Research Center), Largo Agostino Gemelli, 8, 00168, Rome, Italy; Università Cattolica del Sacro Cuore di Roma, Largo Francesco Vito 1, 00168, Rome, Italy.

Introduction: With the prolongation of life expectancy, an increasing number of elderly patients are evaluated for pancreatic surgery. However, the influence of increasing age on outcomes after pancreaticoduodenectomy (PD) is still unclear, especially in octogenarians. Aim of this study is to evaluate the perioperative characteristics and outcomes of octogenarians undergoing PD.

Methods: Data for 812 patients undergoing PD between 2019 and 2020 in 10 referral centers in Italy were reviewed. Patients aged 80 years or older were matched based on nearest neighbor propensity scores in a 1:1 ratio to patients younger than 80 years. Propensity scores were calculated using 7 perioperative variables including gender, ASA score, neoadjuvant treatment (NAT), biliary stent positioning, type of surgical approach (open, laparoscopic, robot-assisted), associated vascular resections, type of lesion. Perioperative characteristics and short-term postoperative outcomes were compared before and after matching.

Results: Overall, 81 (10%) patients had 80 years or more. Before matching, octogenarians had a higher rate of ASA score≥ 3 (n = 35, 43.2% vs. n = 207, 28.3%; p = 0.005) and less frequently underwent NAT (n = 11, 13.6% vs. n = 213, 29.1%; p = 0.003). Matching was successfully performed for 70 octogenarians. After matching, no differences in preoperative and intraoperative characteristics were found. Postoperatively, ICU admission was more frequent in octogenarians (50% vs 30%; p = 0.01). Although in-hospital mortality was higher in octogenarians before matching (7.4% vs 2.9% in the younger cohort; p = 0.03), no difference was noted between the matched cohorts (p = 0.36). Postoperative morbidity was comparable between groups in the whole and selected populations. At the multivariate analysis, chronological age was not recognized as a prognostic factor for cumulative major complications, while ASA ≥3 was the only confirmed influencing feature (OR 2.98; 95%CI: 1.6-6.8; p = 0.009).

Conclusio: In high-volume centers, PD in octogenarians shows similar outcomes than younger patients. Age itself should not be considered an exclusion criterion for PD, but a focused preoperative assessment is essential for adequate patient selection.
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http://dx.doi.org/10.1016/j.suronc.2021.101688DOI Listing
November 2021

Quantitative assessment of the impact of COVID-19 pandemic on pancreatic surgery: an Italian multicenter analysis of 1423 cases from 10 tertiary referral centers.

Updates Surg 2021 Nov 24. Epub 2021 Nov 24.

Department of Surgery, Gemelli Pancreatic Center, Fondazione Policlinico Universitario "Agostino Gemelli", IRCCS, Largo Agostino Gemelli, 8, 00168, Rome, Italy.

Few evidences are present on the consequences of coronavirus disease 2019 (COVID-19) pandemic on pancreatic surgery. Aim of this study is to evaluate how COVID-19 influenced the diagnostic and therapeutic pathways of surgical pancreatic diseases. A comparative analysis of surgical volumes and clinical, surgical and perioperative outcomes in ten Italian referral centers was conducted between the first semester 2020 and 2019. One thousand four hundred and twenty-three consecutive patients were included in the analysis: 638 from 2020 and 785 from 2019. Surgical volume in 2020 decreased by 18.7% (p < 0.0001). Benign/precursors diseases (- 43.4%; p < 0.0001) and neuroendocrine tumors (- 33.6%; p = 0.008) were the less treated diseases. No difference was reported in terms of discussed cases at the multidisciplinary tumor board (p = 0.43), mean time between diagnosis and neoadjuvant treatment (p = 0.91), indication to surgery and surgical resection (p = 0.35). Laparoscopic and robot-assisted procedures dropped by 45.4% and 61.9%, respectively, during the lockdown weeks of 2020. No difference was documented for post-operative intensive care unit accesses (p = 0.23) and post-operative mortality (p = 0.06). The surgical volume decrease in 2020 will potentially lead, in the near future, to the diagnosis of a higher rate of advanced stage diseases. However, the reassessment of the Italian Health Service kept guarantying an adequate level of care in tertiary referral centers. Clinicaltrials.gov ID: NCT04380766.
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http://dx.doi.org/10.1007/s13304-021-01171-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8611384PMC
November 2021

The impact of gastrojejunostomy orientation on delayed gastric emptying after pancreaticoduodenectomy: a single center comparative analysis.

HPB (Oxford) 2021 Sep 24. Epub 2021 Sep 24.

Gemelli Pancreatic Center, CRMPG (Advanced Pancreatic Research Center) Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS; Largo Agostino Gemelli, 8, 00168, Rome, Italy; Università Cattolica Del Sacro Cuore di Roma, Largo Francesco Vito 1, 00168, Rome, Italy.

Background: Delayed gastric emptying (DGE) represents the most frequent complication after pancreaticoduodenectomy (PD). Aim of this study was to evaluate the impact of gastrojejunostomy (GJ)orientation on DGE incidence after PD.

Methods: One-hundred and twenty-one consecutive PDs were included in the analysis and divided in the horizontal (H-GJ group) and vertical GJ anastomosis groups (V-GJ group). Postoperative data and the value of the flow angle between the efferent jejunal limb and the stomach of the GJ anastomosis at the upper gastrointestinal series were registered.

Results: Seventy-five patients (62%)underwent H-GJ, while 46 patients (38%)underwent V-GJ. The incidence of DGE was significantly lower in the V-GJ group as compared to the H-GJ group (23.9%vs45.3%; p = 0.02). V-GJ was also associated to a less severe DGE manifestation (p = 0.006). The flow angle was significantly lower in case of V-GJ as compared to H-GJ (24.5°vs37°; p = 0.002). At the multivariate analysis, ASA score≥3 (p = 0.02), H-GJ (p = 0.03), flow angle>30°(p = 0.004) and Clavien-Dindo≥3 (p = 0.03) were recognized as independent prognostic factors for DGE. These same factors were independent prognostic features also for a more severe DGE manifestation.

Conclusion: VGJ and the more acute flow angle appear to be associated to a lower incidence rate and severity of DGE. This modified technique should be considered by surgeons in order to reduce postoperative DGE occurrence.
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http://dx.doi.org/10.1016/j.hpb.2021.09.015DOI Listing
September 2021

Adhesive small bowel obstruction in elderly patients: a single-center analysis of treatment strategies and clinical outcomes.

Scand J Gastroenterol 2021 Jul 7;56(7):784-790. Epub 2021 May 7.

Digestive Surgery Unit, Fondazione Policlinico Agostino Gemelli IRCCS di Roma, Rome, Italy.

Introduction: The incidence of adhesive bowel obstruction (ASBO) progressively increases with age. Strong evidences on the influencing role of age on ASBO clinical course and management are still lacking. Aim of this study is to retrospectively analyze the clinical outcomes of patients older than 65 years of age admitted to a tertiary referral Emergency Department with a diagnosis of ASBO.

Materials And Methods: We reviewed the clinical records of patients admitted for ASBO in the period 2014-2019. Patients were divided in elderly (≥65 years) and non-elderly (<65 years). Primary endpoint was to compare the all-cause in-hospital mortality and the occurrence of major complications in the two groups. Secondary endpoint was a comparison of clinical presentation, clinical course and management.

Results: We enrolled 285 elderly and 492 non-elderly patients. Vomit was more frequent in the elderly (51.9% vs 34.6%;  < .001), while no difference was evidenced for the remaining symptoms of ASBO presentation. A higher rate of non-operative management (NOM) (26.3% vs 16.5%;  = .010), ICU admission (16% vs 0.6%;  < .001), mortality (2.1% vs 0.2%;  = .007) and cumulative major complications (8.8% vs 3.3%;  = .001), as well as a prolonged hospitalization (8.2 vs 5.4 days;  < .001) was evidenced in the ≥65 years group. Multivariate analysis identified increasing age (OR:2.8; 95%CI:1.09-7.2;  = .040) and Charlson comorbidity index ≥ 2 (OR:2.5; 95% CI:1.2-6.4;  = .050) as the only independent predictors of cumulative major complications.

Conclusions: Despite the similarity in terms of clinical presentation, elderly patient present higher mortality rate and occurrence of major complications. A comprehensive geriatric assessment is recommended to optimize the diagnostic and clinical strategies in case of ASBO.
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http://dx.doi.org/10.1080/00365521.2021.1921256DOI Listing
July 2021

The role of mesopancreas excision for ampullary carcinomas: a single center propensity-score matched analysis.

HPB (Oxford) 2021 Oct 18;23(10):1557-1564. Epub 2021 Apr 18.

Pancreatic Surgery Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; CRMPG (Advanced Pancreatic Research Center), Largo A. Gemelli, 8, 00168, Roma, Italy; Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Roma, Italy.

Background: Few evidences are available on the prognostic role of mesopancreas excision(MPe) for ampullary cancers(ACs). Aim of this study was to compare the long-term outcomes between pancreaticoduodenectomy(PD) with(PD-MPe group) and without(sPD group) MP.

Methods: Thirty-seven sPDs were matched and compared to 37 PD-MPes for perioperative outcomes, recurrence rate, disease-free(DFS) and overall survival(OS).

Results: The PD-MPe technique related to a significantly higher number of harvested lymph nodes[16 (±6)] as compared to the sPD [10 (±5); p < 0.0001]. Tumor recurrence was more frequent in the sPD cohort[21 (56.8%) vs 12 (32.4%) in the PD-MPe population; p = 0.03]. Although not statistically different, PD-MPe was associated with a better DFS(40% vs 35.7% for sPD; p = 0.08) and OS(59.3% vs 39.1% for sPD; p = 0.07). At the multivariate analysis, a higher number of lymph nodes retrieved and a more extensive lymphovascular clearance reached with the MPe technique, together with lymph nodes metastases, were recognized as independent prognostic factors for a worse OS and DFS.

Conclusion: The PD-MPe technique is associated with a better oncological radicality thanks to the higher number of retrieved lymph nodes and to the more appropriate tumor clearance. This reflects in a lower incidence of tumor relapse and in improved outcomes in terms of OS and DFS.
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http://dx.doi.org/10.1016/j.hpb.2021.03.011DOI Listing
October 2021

Challenges in Crohn's Disease Management after Gastrointestinal Cancer Diagnosis.

Cancers (Basel) 2021 Feb 2;13(3). Epub 2021 Feb 2.

Digestive Surgery Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Crohn's disease (CD) is a chronic inflammatory bowel disease with a progressive course, potentially affecting the entire gastrointestinal tract from mouth to anus. Several studies have shown an increased risk of both intestinal and extra-intestinal cancer in patients with CD, due to long-standing transmural inflammation and damage accumulation. The similarity of symptoms among CD, its related complications and the de novo onset of gastrointestinal cancer raises difficulties in the differential diagnosis. In addition, once a cancer diagnosis in CD patients is made, selecting the appropriate treatment can be particularly challenging. Indeed, both surgical and oncological treatments are not always the same as that of the general population, due to the inflammatory context of the gastrointestinal tract and the potential exacerbation of gastrointestinal symptoms of patients with CD; moreover, the overlap of the neoplastic disease could lead to adjustments in the pharmacological treatment of the underlying CD, especially with regard to immunosuppressive drugs. For these reasons, a case-by-case analysis in a multidisciplinary approach is often appropriate for the best diagnostic and therapeutic evaluation of patients with CD after gastrointestinal cancer onset.
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http://dx.doi.org/10.3390/cancers13030574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7867285PMC
February 2021

Robotic rectal resection: oncologic outcomes.

Updates Surg 2021 Jun 10;73(3):1081-1091. Epub 2020 Nov 10.

Digestive Surgery Unit, Fondazione Policlinico Universitario "A. Gemelli" IRCCS di Roma, Largo Agostino Gemelli, 8, 00168, Rome, Italy.

Robotic surgery has progressively gained popularity in the treatment of rectal cancer. However, only a few studies on its oncologic effectiveness are currently present, with contrasting results. The purpose of this study is to report a single surgeon's experience on robotic rectal resection (RRR) for cancer, focusing on the analysis of oncologic outcomes, both in terms of pathological features and long-term results. One-hundred and twenty-two consecutive patients who underwent RRR for rectal cancer from January 2013 to December 2019 were retrospectively enrolled. Patients' characteristics and perioperative outcomes were collected. The analyzed oncologic outcomes were pathological features [distal (DM), circumferential margin (CRM) status and quality of mesorectal excision (TME)] and long-term outcomes [overall (OS) and disease-free survival (DFS)]. The mean operative time was 275 (± 60.5) minutes. Conversion rate was 6.6%. Complications occurred in 27 cases (22.1%) and reoperation was needed in 2 patients (1.5%). The median follow-up was 30.5 (5.9-86.1) months. None presented DM positivity. CRM positivity was 2.5% (2 cases) while a complete TME was reached in 94.3% of cases (115 patients). Recurrence rate was 5.7% (2 local, 4 distant and 1 local plus distant tumor relapse). OS and DFS were 90.7% and 83%, respectively. At the multivariate analysis, both CRM positivity and near complete/incomplete TME were recognized as negative prognostic factors for OS and DFS. Under appropriate logistic and operative conditions, robotic surgery for rectal cancer proves to be oncologically effective, with adequate pathological results and long-term outcomes. It also offers acceptable peri-operative outcomes, further confirming the safety and feasibility of the technique.
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http://dx.doi.org/10.1007/s13304-020-00911-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184562PMC
June 2021

From biology to surgery: One step beyond histology for tailored surgical treatments of gastric cancer.

Surg Oncol 2020 Sep 5;34:86-95. Epub 2020 Apr 5.

Digestive Surgery Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; Università Cattolica del Sacro Cuore di Roma, Italy.

Gastric cancer is the third most common cause of cancer related death. Although its incidence is globally declined, prognosis remains dismal in the Western hemisphere, while better outcomes are evidenced in Asian countries. Endoscopic or surgical resection with or without lymphadenectomy represents the only chance of cure, with limited improvements of the prognosis in case of associated chemotherapy in a neoadjuvant or adjuvant setting. This could be mainly attributed to the uniform fashion of treatment of gastric cancer, mainly based on the histological features, that usually do not reflect the complexity of the disease. With the recent introduction of genomic technologies and new generation sequencing techniques, gastric cancer biology is now investigated in great details. This has brought to the publication of three main molecular classifications, based on the underlying molecular biology of gastric cancer. Although only few clinical reports are currently present in literature, the identification of gastric cancer molecular subtypes has shown interesting findings that may pave the way to a tailored clinical and surgical management. The aim of this review is, thus, to give a comprehensive overview of the current molecular classifications as compared to the available histopathological ones, also focusing on the potential clinical and surgical benefits and the future perspectives for a more personalized treatment of gastric cancer.
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http://dx.doi.org/10.1016/j.suronc.2020.04.004DOI Listing
September 2020

Response to the letter to the editor: Hyperglycemia or inappropriate fluid therapy.

Surgery 2020 09 4;168(3):567. Epub 2020 Jul 4.

Digestive Surgery Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia.

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http://dx.doi.org/10.1016/j.surg.2020.05.024DOI Listing
September 2020

Propensity score-matched comparison of short- and long-term outcomes between surgery and endoscopic submucosal dissection (ESD) for intestinal type early gastric cancer (EGC) of the middle and lower third of the stomach: a European tertiary referral center experience.

Surg Endosc 2021 06 1;35(6):2592-2600. Epub 2020 Jun 1.

Digestive Surgery Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, 00166, Rome, Italy.

Background: Despite the comparable results between ESD and gastrectomy reported in multiple Asiatic studies, limited data are currently present on the long-term efficacy of ESD for EGC in Western countries. The aim of this study was to compare the short- and long-term outcomes of the endoscopic submucosal dissection and surgery for non-diffuse early gastric cancer treatment in a Western cohort of patients.

Methods: All patients with a diagnosis of intestinal type EGC located in the middle and lower third of the stomach from 2005 to 2015 were enrolled in the study. All patients completed a 5-year follow-up. Patients were divided according to the procedure performed (ESD/subtotal gastrectomy). The two groups were matched for age, gender, ASA score, tumor dimension, and grade of infiltration (mucosa/submucosa).

Results: After matching, 84 patients (42 per group) were included in the analysis. Peri-procedural morbidity rate was 7.1% and no difference was observed between the two groups (4.8% vs 9.5% for ESD and STG groups, respectively; p = 0.3). Similar results in terms of 5-year OS and DFS were observed for ESD and STG (77.7% vs 71.8% ; p = 0.78 and 74.9% vs 72% ; p = 0.7, respectively). At the multivariate analysis, ASA3 score was recognized as the only negative predictor factor for the 5-year OS (OR 6.2; 95% CI 2.2-16.8; p < 0.001). Regarding the DFS, both ASA3 score (OR 4.4; 95% CI 1.7-10.9; p < 0.001) and submucosal infiltration(OR 5.1; 95% CI 1.2-22.4 ; p = 0.02) were identified as independent risk factors for a worse outcome.

Conclusions: Our results confirm the safety and feasibility ESD for EGC treatment in a Western setting. In addition, this is one of the few reports showing comparable results both in terms of short- and long-term outcomes between ESD and surgery for intestinal type ECG treatment in Western countries.
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http://dx.doi.org/10.1007/s00464-020-07677-3DOI Listing
June 2021

Postoperative hyperglycemia affects survival after gastrectomy for cancer: A single-center analysis using propensity score matching.

Surgery 2020 05 3;167(5):815-820. Epub 2019 Dec 3.

Digestive Surgery Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.

Background: No data are present currently on the potential correlation between postoperative hyperglycemia and long-term outcomes after gastric surgery for cancer. The aim of this study was to investigate the effects of postoperative hyperglycemia on survival after curative gastrectomy for cancer.

Methods: All patients who underwent gastric surgery for cancer with curative intent were reviewed retrospectively. Diabetic patients and patients who needed pancreatic resection were excluded. In all patients, a prepared intravenous infusion of NaCl and carbohydrates (Isolyte Baxter 2,000 mL/day; glucose 50.0 g/L;Ringers lactate 1,000 mL/day) was used, and the patients were kept nil by mouth until the fourth postoperative day. The glucose levels were monitored during the first 72 hours. The study population was divided into normoglycemic and hyperglycemic patients according to the blood glucose level (<140 mg/dL and ≥140 mg/dL, respectively). The 2 groups were matched for age, sex, type of operative procedure, TNM status, and lymph node status.

Results: After matching, 104 patients were included for the analysis. Perioperative morbidity accounted for 18.3% with a greater rate for hyperglycemic patients (12% vs 31%; P = .018). When compared with normoglycemic patients, hyperglycemic patients had worse overall survival (45% vs 57%; P = .05) and worse disease-free survival (46% vs 68%; P = .02). On the multivariate analysis, hyperglycemia was an independent risk factor for a worse overall and disease-free survival.

Conclusion: Postoperative hyperglycemia owing to surgical stress conditions can affect postoperative outcomes. Additionally, hyperglycemia may be a factor that promotes gastric cancer progression.
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http://dx.doi.org/10.1016/j.surg.2019.11.006DOI Listing
May 2020

Acute pancreatitis in oldest old: a 10-year retrospective analysis of patients referred to the emergency department of a large tertiary hospital.

Eur J Gastroenterol Hepatol 2020 02;32(2):159-165

Digestive Surgery Unit, Department of Surgery, CRMP (Gemelli Pancreatic Advanced Research Center).

Objective: Contrasting results are reported on the clinical course of acute pancreatitis (AP) in the geriatric population. The aim of this study is to compare the AP clinical outcomes between patients aged from 65 to 79 years and those over 80 years.

Methods: A total of 115 patients over 80 years (oldest old) were compared to a group of 236 patients aged 65-79 years (elderly). Clinicodemographic, biochemical, and radiological data were reviewed. The primary outcome was to compare the overall mortality. Secondary outcomes included intensive care unit (ICU) admission, in-hospital length of stay (LOS), and need for surgical procedures.

Results: Laboratory values at admission were similar between the two groups. Over 80 patients presented a lower rate of abdominal symptoms (68.7% vs. 81.4%; P = 0.008), a higher mortality (14.8% vs. 3.5%; P = 0.003), and ICU admission (13.9% vs. 3.8%; P = 0.001) rates. Median LOS was comparable between the two groups. Multivariate analysis identified age [odds ratio (OR): 3.56; 95% confidence interval (CI): 1.502-8.46; P = 0.004], a higher Ranson score (OR: 3.22; 95% CI: 1.24-8.39; P = 0.016), and the absence of abdominal pain (OR: 2.94; 95% CI: 1.25-6.87; P = 0.013) as independent predictors of mortality. Conversely, only age (OR: 3.83; 95% CI: 1.55-9.44; P = 0.003) and a more severe AP (OR: 3.56; 95% CI: 1.95-6.89; P = 0.041) were recognized as influencing ICU admission. Only the operative treatment (OR: 2.805; 95% CI: 1.166-5.443; P = 0.037) was evidenced as independent risk factor for LOS (OR: 3.74; 95% CI: 1.031-6.16; P = 0.003).

Conclusion: Oldest old patients have a higher mortality and ICU admission rate as compared to the other subgroups of elderly. Early diagnosis and prompt treatment are key elements to improve outcomes in this frailer population.
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http://dx.doi.org/10.1097/MEG.0000000000001570DOI Listing
February 2020

Ratio-based staging systems are better than the 7th and 8th editions of the TNM in stratifying the prognosis of gastric cancer patients: A multicenter retrospective study.

J Surg Oncol 2019 Jun 11;119(7):948-957. Epub 2019 Feb 11.

Dipartimento Scienze Gastroenterologiche, Endocrino-Metaboliche e Nefro-Urologiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

Background: The current and the previous editions of the tumor-node-metastasis (TNM) system for gastric cancer (GC; TNM8 and TNM7) have a high risk of stage-migration bias when the node count after gastrectomy is suboptimal. Hence, they are possibly not the optimal staging systems for GC patients. This study aims to compare the TNM with two systems less affected by the stage-migration bias, namely, the lymph nodes ratio (LNR) and the log odds of positive lymph nodes (LODDS), to assess which one is the best in stratifying the prognosis of GC patients.

Methods: The sample study included 1221 GC patients. Two 7-cluster staging systems based on the combination of pT categories and LNR and LODDS categories (TLNR and TLODDS) were compared with the two last editions of TNM, using the Akaike information criteria, the Bayesian information criteria, and the receiver operating characteristic (ROC) curve graphs. Further validation on an independent sample of 251 patients was carried out.

Results: The univariable and multivariable analyses and the ROC curves detected an advantage of the TLNR and TLODDS systems over the TNM. The TLNR and TLODDS showed the best accuracy both in the subgroup of patients with ≥16 nodes examined. The results were confirmed in the validation analysis.

Conclusions: TLNR and TLODDS staging systems should be considered a valid implementation of the TNM for the prognostic stratification of GC patients. If these results are confirmed in further studies, the future implementation of the TNM should consider the introduction of the LNR or the LODDS along with the number of metastatic nodes.
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http://dx.doi.org/10.1002/jso.25411DOI Listing
June 2019

What's in a "research passport"? A collaborative autoethnography of institutional approvals in public involvement in research.

Res Involv Engagem 2016 22;2:24. Epub 2016 Jun 22.

2University of the West of England, Bristol, UK.

Plain English Summary: The article analyses the process of securing permissions for members of the public (we refer to them as "research partners") and academics involved in a qualitative study of public involvement in research (PIR) across eight health sciences projects in England and Wales. All researchers, including research partners, need to obtain a "research passport" from UK NHS trusts where they intend to carry out research. The article presents the experiences and observations of the authors, who all went through the process.Research partners encountered many challenges, as the overall bureaucratic procedures proved burdensome. The effects were felt by the academics too who had to manage the whole process. This influenced the way research partners and academics built social and personal relationships required for the successful conduct of the project. We also discuss the tensions that emerged around the issue of whether research partners should be treated as a professional category on their own, and other issues that influenced the PIR processes.In the concluding section, we make a number of practical recommendations. Project teams should allow enough time to go through all the hurdles and steps required for institutional permissions, and should plan in advance for the right amount of time and capacity needed from project leaders and administrators. Bureaucratic and organisational processes involved in PIR can sometimes produce unanticipated and unwanted negative effects on research partners. Our final recommendation to policy makers is to focus their efforts on making PIR bureaucracy more inclusive and ultimately more democratic.

Abstract: In the growing literature on public involvement in research (PIR), very few works analyse PIR organizational and institutional dimensions in depth. We explore the complex interactions of PIR with institutions and bureaucratic procedures, with a focus on the process of securing institutional permissions for members of the public (we refer to them as "research partners") and academics involved in health research. We employ a collaborative autoethnographic approach to describe the process of validating "research passports" required by UK NHS trusts, and the individual experiences of the authors who went through this journey - research partners and academics involved in a qualitative study of PIR across eight health sciences projects in England and Wales. Our findings show that research partners encountered many challenges, as the overall bureaucratic procedures and the emotional work required to deal with them proved burdensome. The effects were felt by the academics too who had to manage the whole process at an early stage of team building in the project. Our thematic discussion focuses on two additional themes: the emerging tensions around professionalisation of research partners, and the reflexive effects on PIR processes. In the concluding section, we make a number of practical recommendations. Project teams should allow enough time to go through all the hurdles and steps required for institutional permissions, and should plan in advance for the right amount of time and capacity needed from project leaders and administrators. Our findings are a reminder that the bureaucratic and organisational structures involved in PIR can sometimes produce unanticipated and unwanted negative effects on research partners, hence affecting the overall quality and effectiveness of PIR. Our final recommendation to policy makers is to focus their efforts on making PIR bureaucracy more inclusive and ultimately more democratic.
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http://dx.doi.org/10.1186/s40900-016-0033-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831890PMC
June 2016
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