Papillary Thyroid Microcarcinoma: Differences between Lesions in Incidental and Nonincidental Settings-Considerations on These Clinical Entities and Personal Experience.

Papillary thyroid microcarcinoma (PTMC) represents 35-40% of all papillary cancers; it is defined as a nodule ≤ 10 mm at the time of histological diagnosis. The clinical significance of PTMC is still controversial, and it may be discovered in two settings: incidental PTMC (iPTMC), in which it is identified postoperatively upon histological examination of thyroid specimens following thyroid surgery for benign disease, and nonincidental PTMC (niPTMC), in which it is diagnosed before surgery. While iPTMC appears to be related to mild behavior and favorable clinical outcomes, niPTMC may exhibit markers of aggressiveness. We retrospectively review our experience, selecting 54 PTMCs: 28 classified as niPTMC (52%) and 26 classified as iPTMC (48%). Patients with niPTMC showed significant differences, such as younger age at diagnosis (p < 0.001); a lower male/female ratio (p < 0.01); a larger mean nodule diameter (p < 0.001); and a higher rate of aggressive pathological findings, such as multifocality, capsular invasion and/or lymphovascular invasion (p = 0.035). Other differences found in the niPTMC subgroup included a higher preoperative serum TSH level, higher hospital morbidity and a greater need for postoperative iodine ablation therapy (p < 0.05), while disease-free long-term survival did not differ between subgroups (p = 0.331) after a mean follow-up (FU) of 87 months, with one nodal recurrence among niPTMCs. The differences between iPTMC and niPTMC were consistent: patients operated on for total thyroidectomy and showing iPTMC can be considered healed after surgery, and follow-up should be designed to properly calibrate hormonal supplementation; conversely, niPTMC may sometimes exhibit aggressive behavior, and so the FU regimen should be closer and aimed at early detection of cancer recurrence.

Management of low colorectal anastomotic leakage using negative pressure therapy with Transanal Minimally Invasive Surgery (TAMIS): description of a case and review of the literature.

Anastomotic leakage (AL) represents a major post-operative complication after low anterior resection (LAR) for rectal cancer. It is associated with increased morbidity, mortality, length of hospital stay and risk of permanent stoma. Herein we report the case of a 75-year-old male patient submitted to a minimally invasive LAR who developed an AL on the fifth post-operative day. This complication has been successfully managed by placing a Vacuum-Assisted Therapy device (Endo-SPONGE®) with an unusual Transanal Minimally Invasive Surgery (TAMIS) approach; the size of the abscess cavity was measured and the Endo-SPONGE® was cut according to the size of the fistulous defect. This procedure has been performed at regular intervals, achieving quick reduction of anastomotic defect. After the discharge from our department, the patient was addressed to adjuvant treatment. TAMIS may represent an alternative to the endoscopic approach to position an Endo-SPONGE® whenever a conservative management of an AL is required.

Small bowel adenocarcinoma: natural history of recurrence after surgical resection.

Small bowel adenocarcinomas (SBA) are a rare entity associated with a poor prognosis and an advanced stage of disease at diagnosis. Surgical resection is considered the gold standard of treatment for stage I-III, while stage IV disease approach is still debated. We present a case of a young woman affected by a duodenojejunal junction SBA treated with surgical resection and FOLFOX adjuvant chemotherapy. The patient later underwent a palliative duodenojejunal bypass for peritoneal carcinomatosis.

Extended surgical resection for nonfunctioning duodenal neuroendocrine tumor.

Duodenal neuroendocrine tumors (NETs) account for <3% of all gastrointestinal NET. Most lesions are small-sized and are located in the first or second duodenal part. Tumoral grading, evaluated by Ki67 index, strongly influences patient's outcome. Endoscopic resection is recommended for lesions measuring <2 cm, while pancreaticoduodenectomy should be the treatment of choice for large duodenal NET; Whipple procedure should be preferred in case of duodenal origin and contiguity with gastric antrum. Involvement of surrounding structures, as well as the presence of resectable liver metastases, does not contraindicate surgical resection. Herein we report a case of a 68-year-old male, presenting with an extensive mass of the descending pre-ampullary duodenal part, with involvement of the right colon and the presence of a pericholecystic single liver metastasis. In spite of such advanced disease, surgery on the patient was successful, with an uneventful postoperative outcome.

Hybrid sequential treatment of a giant serous mesenteric cyst: description of a case and review of the literature.

Mesenteric cysts are uncommon benign abdominal tumors that may extend from the root of the mesenteric layers of the gastrointestinal tract into the retroperitoneum or the peritoneal cavity; they are usually asymptomatic and often represent an occasional finding. Definitive diagnosis is confirmed by the surgical intraoperative view and by histopathological examination. Surgical excision of the cyst is the treatment of choice. We present a case of a female patient who presented with back pain and a palpable abdominal mass. Due to large size of the mass and its contiguity with midline, patient underwent an hybrid combined surgical technique, with a first open phase followed by a laparoscopic excision. Complete surgical removal of the cyst was successfully performed without bowel resection, intraoperative spillage of cystic content and without morbidity. Histopathology confirmed diagnosis of simple mesenteric cyst. We strongly recommend a combined approach whenever a large intraperitoneal benign cystic lesion has been diagnosed.

Functional results after mesorectal excision for rectal cancer: comparative study among surgical approaches.

BACKGROUND: We analyzed the evolution of genitourinary dysfunctions in patients undergoing surgical treatment for rectal cancer, and compared open surgery, laparoscopy, robotic and TaTME. METHODS: Functional outcomes were evaluate using standardized questionnaires, compiled at the start of treatment, after the end of Radiotherapy, at 1 and 6 months after surgery. RESULTS: In 72 patients 37.5% had low, 27.8% middle, and 34.7% high rectal cancers. Open technique was performed in 25% of cases, while 29.2% underwent laparoscopy, 20.8% TaTME and 25% robotic. We noted a deterioration in urogenital function: surgical technique can influence the result both in urinary and male sexual function but not ejaculation. Robotics and laparoscopy bring better outcomes than open surgery and TaTME. Female sexuality worsening seems not influenced by the technique. In general age, stage, complications, and anastomotic leakage appear to be predictive factors for functional dysfunctions. As reported in literature rectal cancer treatment leads to urogenital worsening: this seems to be progressive in male sexuality only, while female one and urinary function show a slight improvement in the first months, although a full recovery possibility is discussed. Is also reported how robotic and laparoscopy have a lower functional impact. TaTME has gained consensus thank to the excellent oncological and function outcomes, but in our study leads to worse results. CONCLUSIONS: Mini-invasive techniques guarantee the same oncological result than more invasive ones, but with better functional outcomes and tolerability; robotic surgery seems to be slight superior to laparoscopy, but with longer operative time.

Regret and Quality of Life After Mastectomy With or Without Reconstruction.

BACKGROUND: Mastectomy represents a deep burden for women with breast cancer. Very little is known about the psychological consequences over time and the quality of life (QoL) of women so treated, with or without breast reconstruction (BR). PATIENTS AND METHODS: A total of 709 patients underwent mastectomy with or without BR between 2002 and 2012 at one institution. Among 468 surviving patients, a 60-query QoL questionnaire on personal issues including some European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire items was presented either by email, letter, or telephone interview. RESULTS: Of those questioned, 328 patients participated, whereas 140 (30%) declined the invitation or were unavailable. The median age was 63 years (range, 30-93 years). Stage I or II of disease was recorded in 73% of patients. Immediate BR was performed in 168 (51%) of 328 patients. Of the remaining patients, only 7 (4%) of 160 proceeded to delayed BR. Younger women had significantly worse Emotional Functioning and Social Functioning (SF) scores (P < .001), independently of tumor stage, and immediate BR improved that (P = .02). SF score was also worsened by chemotherapy (P = .03). Cognitive Functioning score was independent of age, BR, stage, or adjuvant therapies. Body Image and Sexual Functioning scores improved with BR (P < .03), and age was a strong co-variable (P < .001). On multivariate analysis, immediate BR was correlated with age and preoperative plastic surgery consultation. Some 68 (21%) of 328 patients regretted their decision or were disappointed with their choice regarding BR. CONCLUSIONS: Younger patients with breast cancer report a worse impact on their Emotional Functioning and SF scores after mastectomy, both of which are improved by BR. Reconstructing the breast at the time of mastectomy has a significant impact on Body Image and Sexual Functioning scores. A preoperative plastic surgeon consultation improves the rate of immediate BR, whereas delayed reconstruction is rarely adopted. Some 20% of patients are disappointed in or regret their decision regarding BR. We need to improve our management in consideration of these findings.

Virtual User in the IoT: Definition, Technologies and Experiments.

Virtualization technologies are characterizing major advancements in the Internet of Things (IoT) arena, as they allow for achieving a cyber-physical world where everything can be found, activated, probed, interconnected, and updated at both the virtual and the physical levels. We believe these technologies should apply to human users other than things, bringing us the concept of the Virtual User (VU). This should represent the virtual counterpart of the IoT users with the ultimate goal of: (i) avoiding the user from having the burden of following the tedious processes of setting, configuring and updating IoT services the user is involved in; (ii) acting on behalf of the user when basic operations are required; (iii) exploiting to the best of its ability the IoT potentialities, always taking always account the user profile and interests. Accordingly, the VU is a complex representation of the user and acts as a proxy in between the virtual objects and IoT services and application; to this, it includes the following major functionalities: user profiling, authorization management, quality of experience modeling and management, social networking and context management. In this respect, the major contributions of this paper are to: provide the definition of VU, present the major functionalities, discuss the legal issues related to its introduction, provide some implementation details, and analyze key performance aspects in terms of the capability of the VU to correctly identify the user profile and context.

Application of failure mode and effect analysis in total laparoscopic hysterectomy in benign conditions.

BACKGROUND: Hysterectomy is the most common major gynecological operation in developed countries. The rate of intraoperative complications related to the laparoscopic approach during hysterectomy is a relevant issue. The failure mode and effect analysis (FMEA) method is a prospective approach, which tries to identify possible errors before they occur. METHODS: In this study we applied the FMEA method to laparoscopic approach to hysterectomy in order to reduce the theorized risk of intraoperative complications. We selected a team who analyzed and deconstructed the total laparoscopic hysterectomy (TLH) process recording on the FMEA worksheet phases and activities of the entire procedure. Each activity-related failure mode and their potential effects were developed. The team also described actions to eliminate or decrease the likelihood of mistakes. RESULTS: A numerical value reflecting the risk was assigned to each activity. Five activities were identified as high priority risk, and for each activity actions were then taken to mitigate the identified risk. After introduction of these actions, the risk scores for each activity were recalculated, and we obtained a total risk reduction of 55%. CONCLUSIONS: It is our opinion that the systematic implementation of the FMEA model can reduce the risk of human error during laparoscopic surgery, improving patient safety.

Analysis of the approach to risk management in onco-hematology centers: results of a survey in Italy.

PURPOSE: Raccomandazione 14 (Recommendation 14), issued by the Italian Ministry of Health, is aimed at providing requirements for preventing medication errors with antineoplastic drugs. Raccomandazione 14 covers all steps of the process, from supply to administration of therapies with specific conclusive guidance on tools and methods to be adopted for the assessment and management of clinical risk. METHODS: A form and a score system were designed and provided to healthcare professionals for self-assessment of adherence to Raccomandazione 14. Data were collected during 2014-2015 and a score was given to each item. Specific gaps were listed for each center. RESULTS: A total of 27 healthcare institutions participated in the project, with 447 healthcare personnel (physician, nurses, and pharmacists) involved. The mean overall adherence score for all items covered by Raccomandazione 14 was 2.8 (out of 4). Items with scores <2.8 were considered priority targets for intervention for risk mitigation (general requirements, supply, oral administration, therapy management for injected antineoplastic drugs in home care setting administration, and involvement of patients in care process). The other items of Raccomandazione 14 defined as core processes in the management of anticancer therapies achieved an overall mean score of 3.1 (storage/inventory management, prescription, preparation, distribution, and administration). Following the analysis of the results, the 27 participating institutions activated a range of 3-29 actions/institution for improving adherence to best practice requirements. CONCLUSIONS: The survey was able to identify specific gaps with Raccomandazione 14 at different institutions throughout Italy so that the healthcare professionals involved were able to prioritize improvement actions that should be able to minimize risk in the management of oncologic drugs in the in-hospital setting.

Administrative risk quantification of subcutaneous and intravenous therapies in Italian centers utilizing the Failure Mode and Effects Analysis approach.

BACKGROUND: In oncology, an important parameter of safety is the potential treatment error in hospitals. The analyzed hypothesis is that of subcutaneous therapies would provide a superior safety benefit over intravenous therapies through fixed-dose administrations, when analyzed with trastuzumab and rituximab. METHODS: For the calculation of risk levels, the Failure Mode and Effect Analysis approach was applied. Within this approach, the critical treatment path is followed and risk classification for each individual step is estimated. For oncology and hematology administration, 35 different risk steps were assessed. The study was executed in 17 hematology and 16 breast cancer centers in Italy. As intravenous and subcutaneous were the only injection routes in medical available for trastuzumab and rituximab in oncology at the time of the study, these two therapies were chosen. RESULTS: When the risk classes were calculated, eight high-risk areas were identified for the administration of an intravenous therapy in hematology or oncology; 13 areas would be defined as having a median-risk classification and 14 areas as having a low-risk classification (total risk areas: n=35). When the new subcutaneous formulation would be applied, 23 different risk levels could be completely eliminated (65% reduction). Important high-risk classes such as dose calculation, preparation and package labeling, preparation of the access to the vein, pump infusion preparation, and infusion monitoring were included in the eliminations. The overall risk level for the intravenous administration was estimated to be 756 (ex-ante) and could be reduced by 70% (ex-post). The potential harm compensation for errors related to pharmacy would be decreased from eight risk classes to only three risk classes. CONCLUSION: The subcutaneous administration of trastuzumab (breast cancer) and rituximab (hematology) might lower the risk of administration and treatment errors for patients and could hence indirectly have a positive financial impact for hospitals.

Potential resource and cost saving analysis of subcutaneous versus intravenous administration for rituximab in non-Hodgkin's lymphoma and for trastuzumab in breast cancer in 17 Italian hospitals based on a systematic survey.

INTRODUCTION: Subcutaneous versions of different oncology therapies have been available for patients for a few years, yet patient-relevant and hospital benefits have not been assessed in real life. METHODS: In order to analyze the impact of subcutaneous administrations for rituximab or trastuzumab in comparison to the respective intravenous mode a primary research in Italy was executed. The study's primary objectives were to analyze the resource and cost implications from different perspectives (patient, medical staff) in the real world. The route of administration was discussed and aligned with the participating centers in order to capture all relevant therapy parts. After the successful execution of a pilot study 19 centers in six regions in Italy were recruited to participate. RESULTS: Significant time savings might be achieved with the subcutaneous mode through significantly lower patient preparation time including less time preparing the actual dosing for each individual patient. The total time difference is 3.3 hours with rituximab in hematology (non-Hodgkin's lymphoma), which adds up to 23.55 hours for a full course of treatment per patient (overall preparation time: 40.1 hours intravenous [95% confidence interval (CI): ±0.47] vs 16.6 hours subcutaneous [95% CI: ±0.2]). In early breast cancer (trastuzumab), the time saving might be 3.3 hours for the first cycle and the total time saving for patient preparation might be 17.2 hours (overall preparation time: 38.8 hours intravenous [95% CI: ±9.42] vs 21.6 hours subcutaneous [95% CI: ±9.9]). Furthermore, in both settings, the time of medical staff was reduced and could hence be used elsewhere. Finally, in case wastage was experienced with intravenous therapies, there were potential significant reductions in wastage through the subcutaneous administration (93%-100%) with cost savings of €6,057 with rituximab subcutaneous and €28,399 with trastuzumab subcutaneous administration for the full treatment course. CONCLUSION: There are significant resource and cost savings due to subcutaneous administration with rituximab and trastuzumab in Italy based on a systematic survey. With the availability of a subcutaneous use of rituximab and trastuzumab, hospitals, patients and payers in general still have the current standard of care therapies available in the approved indications for a more efficient use of time and resources.

Uptake from water, internal distribution and bioaccumulation of selenium in Scenedesmus obliquus, Unio mancus and Rattus norvegicus: part B.

(75)Se-selenite transfer was investigated in a phytoplankton-mussel-rat food chain model consisting of Scenedesmus obliquus (Turpin) Kützing, Unio mancus Lamark and Rattus norvegicus Berkenhout. (75)Se-metabolized forms were investigated in order to identify potential critical steps in the food chain, as well as its relative bioavailability looking also at intracellular, cellular and organ partitioning. Tissue and intracellular distribution of (75)Se in mussels fed with (75)Se-S. obliquus was different compared to those exposed only to inorganic (75)Se-selenite. The intracellular distribution of (75)Se in the hepatopancreas and mantle of mussels fed (75)Se-microalgae was similar to hepatic and renal distributions in rats, suggesting that their stomach dissociated larger (75)Se-containing molecules. The (75)Se partitioned from water (culture medium) to microalgae showing a bioconcentration factor of 435. The bottleneck in the trophic transfer of (75)Se occurred between S. obliquus-U. mancus. From microalgae to mussels and subsequently to rats no bioaccumulation was verified.

Uptake from water, internal distribution and bioaccumulation of selenium in Scenedesmus obliquus, Unio mancus and Rattus norvegicus: part A.

The (75)Se internal bioavailability was investigated in microalgae, mussels and rats as biological experimental models. The (75)Se accumulation from freshwater to microalgae [Scenedesmus obliquus (Turpin) Kützing], from freshwater to mussels (Unio mancus Lamark) and, finally, per os to rats (Rattus norvegicus Berkenhout) was followed using (75)Se-labelled selenite looking at (75)Se uptake, retention, intracellular distribution and binding with cellular biocomplexes. After exposure to 10, 50 and 500 µg Se L(-1), the microalgae showed an inhibitory effect on population growth only at the highest concentration. Mussels exposed to 105 µg Se L(-1) showed an accumulation of the element with time in all tissues. Intracellularly, Se was present in all subcellular fractions, especially in the cytosol. Rats were treated via oral administration with 5 µg Se rat(-1). After 24 h, liver and kidney showed the highest Se concentration.

Interaction with culture medium components, cellular uptake and intracellular distribution of cobalt nanoparticles, microparticles and ions in Balb/3T3 mouse fibroblasts.

The mechanistic understanding of nanotoxicity requires the physico-chemical characterisation of nanoparticles (NP), and their comparative investigation relative to the corresponding ions and microparticles (MP). Following this approach, the authors studied the dissolution, interaction with medium components, bioavailability in culture medium, uptake and intracellular distribution of radiolabelled Co forms (CoNP, CoMP and Co(2+)) in Balb/3T3 mouse fibroblasts. Co(2+) first saturates the binding sites of molecules in the extracellular milieu (e.g., albumin and histidine) and on the cell surface. Only after saturation, Co(2+) is actively uptaken. CoNP, instead, are predicted to be internalised by endocytosis. Dissolution of Co particles allows the formation of Co compounds (CoNP-rel), whose mechanism of cellular internalisation is unknown. Co uptake (ranking CoMP > CoNP > Co(2+)) reached maximum at 4 h. Once inside the cell, CoNP spread into the cytosol and organelles. Consequently, massive amounts of Co ions and CoNP-rel can reach subcellular compartments normally unexposed to Co(2+). This could explain the fact that the nuclear and mitochondrial Co concentrations resulted significantly higher than those obtained with Co(2+).

Cytotoxicity and morphological transforming potential of cobalt nanoparticles, microparticles and ions in Balb/3T3 mouse fibroblasts: an in vitro model.

We previously described the behaviour of different cobalt forms, i.e., cobalt nanoparticles (CoNP), cobalt microparticles (CoMP) and cobalt ions (Co(2+)), in culture medium (dissolution, interaction with medium components, bioavailability) as well as their uptake and intracellular distribution in Balb/3T3 mouse fibroblasts (Sabbioni, Nanotoxicology, 2012). Here, we assess the cytotoxicity and morphological transformation of CoNP compared not only to Co(2+), but also to CoMP and to released Co products. Cytotoxicity reached maximum at 4-h exposure, with ranking CoMP > CoNP > Co(2+). However, if we consider toxicity as a function of intracellular Co, toxicity of the ionic forms seems to prevail over the particles. Co forms other than Co(2+) released from particles had toxicity intermediate between particles and ions. Alterations in concentrations of essential elements (Cu, Mg, Zn) in cells exposed to Co particles may contribute to toxicity. Both CoMP and CoNP (but not Co(2+) and other released Co forms) induced morphological transformation (CoMP > CoNP). This was dependent on reactive oxygen species production and lipid peroxidation, as indicated by inhibition of type III foci with ascorbic acid. The present results suggest that the previously demonstrated massive mitochondrial and nuclear Co internalisation and DNA adduct formation by CoMP and CoNP (Sabbioni, Nanotoxicology, 2012) induce toxicity and transformation. On the contrary, the role of ions released by particles in culture medium is negligible. Thus, both the chemical and the physical properties of Co particles contribute to cytotoxicity and morphological transformation.

When mastectomy is needed: is the nipple-sparing procedure a new standard with very few contraindications?

BACKGROUND AND OBJECTIVES: Nipple-sparing mastectomy (NSM) improves cosmetic results after mastectomy. As most consider advanced tumors, or tumors near the nipple-areola complex (NAC), as a contraindication for this type of surgery, we challenged this hypothesis. METHODS: One hundred thirty-eight NSM were performed in 121 consecutive patients. In 122 procedures for cancer, patients were included if there was no evidence of NAC proximity (<1 cm), and if the retro-areolar margin was negative, even for locally advanced tumors or after neoadjuvant chemotherapy. RESULTS: Total NAC necrosis occurred in six cases (4.3%). Additionally, NAC was removed after histological exam of the retro-areolar tissue in 19 cases (16% of cancer patients). Among 93 cases whose tumor-to-NAC distance was recorded, NAC was removed in 11/31 cases (35%) if the distance was 1 cm, and in 8/62 cases (12.9%) if it was more than 1 cm (P = 0.01). NAC was removed more frequently in the first half of the study (17/69 vs. 8/69: P = 0.05). At a median follow-up of 26 months for the cancer patient group, there was only one local recurrence (outside the NAC). CONCLUSIONS: Our experience adds evidence that NSM is safe, if the retro-areolar resection margin is clear and maximal surgical clearance is performed.

Selenium- and zinc-deficient cardiomyopathy in human intestinal malabsorption: preliminary results of selenium/zinc infusion.

AIMS: Patients with intestinal malabsorption may develop cardiac dysfunction the origin of which is often unclear. We sought to investigate the pathogenesis of dilated cardiomyopathy in human malabsorption. METHODS AND RESULTS: Eighteen patients with intestinal bypass as treatment for severe obesity and cardiomyopathy underwent endomyocardial biopsy. Biopsies were processed by histology, electron microscopy, polymerase chain reaction (PCR) for cardiotropic viruses, instrumental neutron activation analysis (INAA) of 33 myocardial trace elements, and assessment of glutathione peroxidase (GPX) activity and LC3-II expression. Histology and electron microscopy showed hypertrophy/degeneration of cardiomyocytes with pronounced cell autophagy and high expression of LC3-II. PCR was negative for viral genomes. INAA showed severe myocardial selenium (Se) and zinc (Zn) deficiency and reduced GPX activity vs. both patients with idiopathic dilated cardiomyopathy and normal controls. Se and Zn were added to antifailing heart therapy in 10 patients (group A1) agreeing to a control biopsy, and the response was compared with that of 8 patients (group A2) on supportive therapy alone. After 6 months, myocardial normalization of Se, Zn, LC3-II, and GPX in group A1 was associated with recovery of cardiomyocyte degeneration and autophagy, and significant improvement in cardiac dimension and function, that remained unchanged in group A2. CONCLUSION: A reversible Se- and Zn-deficient cardiomyopathy may occur in patients with intestinal malabsorption. It is characterized by decline of myocardial antioxidant reserve, oxidative damage of cell membranes, and enhanced cell autophagy.

Lobular breast cancer: same survival and local control compared with ductal cancer, but should both be treated the same way? analysis of an institutional database over a 10-year period.

BACKGROUND: Invasive lobular carcinoma (ILC) is believed to be more often multicentric and bilateral compared with invasive ductal cancer (IDC), leading clinicians to pursue a more aggressive local and contralateral approach. METHODS: Retrospective review of a consecutive cohort of breast cancer patients operated at one institution from January 2000 to January 2010 was performed. Median follow-up was 4 years. RESULTS: There were 171 ILC (14.5%) and 1,011 IDC patients in the study period. Median age (63 vs. 65 years) and tumor diameter (1.7 cm) were similar in the two groups. Diagnoses of ILC were more frequent in the second half of the study period (55/465 vs. 116/662, p<0.01). Multicentricity was reported in 108/1,011 (10.6%) IDC and in 31/171 (18.1%) ILC patients (p<0.01). A positive margin of resection at initial surgery was documented in 71/1,011 (7%) IDC and in 21/171 (12.3%) ILC patients (p<0.001). Although the rate of mastectomy decreased over time in both groups, this was more pronounced for ILC patients (p<0.001). Locoregional control, contralateral cancer, overall survival, disease-free survival, and survival according to diameter, nodal status, and type of surgical intervention did not differ between IDC and ILC. On multivariate analysis, stage of disease and hormone receptor status were associated with disease-free survival, but histology was not. CONCLUSIONS: Although ILC is more often multicentric, bilateral, and associated with a positive margin of resection, local control and survival are similar to IDC. ILC can be treated similarly to IDC with good results.

Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

BACKGROUND: The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients. METHODS: FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one. RESULTS: Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization. CONCLUSIONS: Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.