Cost estimation alongside a multi-regional, multi-country randomized trial of antenatal ultrasound in five low-and-middle-income countries.

BACKGROUND: Improving maternal health has been a primary goal of international health agencies for many years, with the aim of reducing maternal and child deaths and improving access to antenatal care (ANC) services, particularly in low-and-middle-income countries (LMICs). Health interventions with these aims have received more attention from a clinical effectiveness perspective than for cost impact and economic efficiency. METHODS: We collected data on resource use and costs as part of a large, multi-country study assessing the use of routine antenatal screening ultrasound (US) with the aim of considering the implications for economic efficiency. We assessed typical antenatal outpatient and hospital-based (facility) care for pregnant women, in general, with selective complication-related data collection in women participating in a large maternal health registry and clinical trial in five LMICs. We estimated average costs from a facility/health system perspective for outpatient and inpatient services. We converted all country-level currency cost estimates to 2015 United States dollars (USD). We compared average costs across countries for ANC visits, deliveries, higher-risk pregnancies, and complications, and conducted sensitivity analyses. RESULTS: Our study included sites in five countries representing different regions. Overall, the relative cost of individual ANC and delivery-related healthcare use was consistent among countries, generally corresponding to country-specific income levels. ANC outpatient visit cost estimates per patient among countries ranged from 15 to 30 USD, based on average counts for visits with and without US. Estimates for antenatal screening US visits were more costly than non-US visits. Costs associated with higher-risk pregnancies were influenced by rates of hospital delivery by cesarean section (mean per person delivery cost estimate range: 25-65 USD). CONCLUSIONS: Despite substantial differences among countries in infrastructures and health system capacity, there were similarities in resource allocation, delivery location, and country-level challenges. Overall, there was no clear suggestion that adding antenatal screening US would result in either major cost savings or major cost increases. However, antenatal screening US would have higher training and maintenance costs. Given the lack of clinical effectiveness evidence and greater resource constraints of LMICs, it is unlikely that introducing antenatal screening US would be economically efficient in these settings--on the demand side (i.e., patients) or supply side (i.e., healthcare providers). TRIAL REGISTRATION: Trial number: NCT01990625 (First posted: November 21, 2013 on https://clinicaltrials.gov ).

Association of haemoglobin levels in the first trimester and at 26-30 weeks with fetal and neonatal outcomes: a secondary analysis of the Global Network for Women's and Children's Health's ASPIRIN Trial.

OBJECTIVE: Limited data are available from low- and middle-income countries (LMICs) on the relationship of haemoglobin levels to adverse outcomes at different times during pregnancy. We evaluated the association of haemoglobin levels in nulliparous women at two times in pregnancy with pregnancy outcomes. DESIGN: ASPIRIN Trial data were used to study the association between haemoglobin levels measured at 6+0 -13+6  weeks and 26+0 -30+0  weeks of gestation with fetal and neonatal outcomes. SETTING: Obstetric care facilities in Pakistan, India, Kenya, Zambia, The Democratic Republic of the Congo and Guatemala. POPULATION: A total of 11 976 pregnant women. METHODS: Generalised linear models were used to obtain adjusted relative risks and 95% CI for adverse outcomes. MAIN OUTCOME MEASURES: Preterm birth, stillbirth, neonatal death, small for gestational age (SGA) and birthweight <2500 g. RESULTS: The mean haemoglobin levels at 6+0 -13+6  weeks and at 26-30 weeks of gestation were 116 g/l (SD 17) and 107 g/l (SD 15), respectively. In general, pregnancy outcomes were better with increasing haemoglobin. At 6+0 -13+6  weeks of gestation, stillbirth, SGA and birthweight <2500 g, were significantly associated with haemoglobin of 70-89 g/l compared with haemoglobin of 110-129 g/l The relationships of adverse pregnancy outcomes with various haemoglobin levels were more marked at 26-30 weeks of gestation. CONCLUSIONS: Both lower and some higher haemoglobin concentrations are associated with adverse fetal and neonatal outcomes at 6+0 -13+6  weeks and at 26-30 weeks of gestation, although the relationship with low haemoglobin levels appears more consistent and generally stronger. TWEETABLE ABSTRACT: Both lower and some higher haemoglobin concentrations were associated with adverse fetal and neonatal outcomes at 6-13 weeks and 26-30 weeks of gestation.

Endotypes of chronic rhinosinusitis with nasal polyps with and without NSAID â€" intolerance.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2-dominated inflammatory disease of the upper air- ways. A subgroup of patients with CRSwNP suffer from intolerance to nonsteroidal anti-inflammatory drugs (NSAID) and develop NSAID-exacerbated respiratory disease (NERD). The aim of the study was to compare the cytokine based inflammatory endotype of nasal secretions of CRSwNP patients with and without NSAID intolerance. METHODS: Nasal secretions were collected from twenty-six patients suffering from CRSwNP, thirteen with NERD and thirteen without NSAID intolerance. As control, nasal secretions were collected from fifteen healthy donors. Tryptase and ten human cyto- kines were analyzed: interleukin (IL)-4, IL-5, IL-6, IL-8, IL-12p70, IL-13, IL-17A, IL-23, IFN-g, and TNF-a by a cytokine multiple array on a Luminex 200 platform. RESULTS: Grade of polyposis and frequency of polyp surgery was more severe in NERD- compared to non-NERD patients. IL-6 and IL-5 in CRSwNP was significantly increased compared to healthy participants. IL-5 and IL-13 were significantly increased in subjects suffering from NERD compared to CRSwNP patients without NERD. CONCLUSION: We identified IL-13 as a possible specific biomarker in nasal secretions of patients with NERD, which allows us to differentiate between CRSwNP with vs. without NERD. The characterization of inflammatory endotypes in CRSwNP enables the introduction of the best available therapy in the context of precision medicine.

Open rhinoplasty using a columellar strut: effects of the graft on nasal tip projection and rotation.

BACKGROUND: Despite the discordance in the literature concerning the effect of columellar strut grafts on nasal tip rotation, this method is often used when an increase in nasolabial angle or nasal tip projection is desired. OBJECTIVES: We aimed to elucidate the change in nasolabial angles and nasal tip projections after exclusive columellar strut graft implantations and in addition to other surgical steps. Furthermore, differences in these parameters between patients with conchal and septal columellar strut grafts were investigated. METHODS: A monocentric retrospective cohort study of 173 open septorhinoplasties with columellar strut graft technique, between 2006 and 2016, was conducted. The pre- and postoperative nasal tip projection, nasolabial and nasofrontal angle and interalar distance were determined and the Goode-ratio was calculated. RESULTS: In cases where uprotation was not specifically desired, neither nasolabial angles nor tip projections changed significantly, irrespective of whether a columellar strut graft was used alone or with additional surgical steps. If an uprotation through surgery was desired, a significant mean increase in nasolabial angle of 4.4° was achieved. Furthermore, conchal instead of septal columellar strut grafts showed significantly better results. CONCLUSION: In our study, a columellar strut graft-without any additional surgical step-does only have an improving impact on nasal tip rotations and projections, if specifically intended to by the surgeon. In other words, if the strut graft was not chosen for an uprotational intention, it did not relevantly impact on the nasolabial angle or nasal tip projection. However, in patients where an uprotation is desired, the columellar strut graft still represents a meaningful tool. Since conchal instead of septal columellar strut grafts showed better results, we suggest using them for these patients. LEVEL OF EVIDENCE: 2b.

Concomitant Ro/SSA and La/SSB antibodies are biomarkers for the risk of venous thromboembolism and cerebral infarction in primary Sjögren's syndrome.

BACKGROUND: To assess the risk of incident cardiovascular disease in patients with primary Sjögren's syndrome, overall and stratified by Ro/SSA and La/SSB autoantibody status. METHODS: A cohort of patients with primary Sjögren's syndrome in Sweden (n = 960) and matched controls from the general population (n = 9035) were included, and data extracted from the National Patient Register to identify events of myocardial infarction, cerebral infarction and venous thromboembolism. Hazard ratios were estimated using cox proportional hazard regressions. RESULTS: During a median follow-up of 9.5 years, the overall hazard ratio (HR) was 1.6 (95% CI 1.2-2.1) for myocardial infarction, 1.2 (95% CI 0.9-1.7) for cerebral infarction and 2.1 (95% CI 1.6-2.9) for venous thromboembolism. Patients positive for both Ro/SSA and La/SSB autoantibodies had a substantially higher risk of cerebral infarction (HR 1.7, 95% CI 1.0-2.9) and venous thromboembolism (HR 3.1, 95% CI 1.9-4.8) than the general population. These risks were not significantly increased in Ro/SSA- and La/SSB-negative patients. Among autoantibody-positive patients, the highest HR of cerebral infarction was seen after ≥10 years disease duration (HR 2.8, 95% CI 1.4-5.4), while the HR for venous thromboembolism was highest 0-5 years after disease diagnosis (HR 4.7, 95% CI 2.3-9.3) and remained high throughout disease duration. CONCLUSIONS: Primary Sjögren's syndrome is associated with a markedly increased risk of cardiovascular disease and the presence of Ro/SSA and La/SSB autoantibodies identify the subgroup of patients carrying the highest risk. These findings suggest that monitoring and prevention of cardiovascular disease in this patient group should be considered.

Infections increase the risk of developing Sjögren's syndrome.

OBJECTIVE: Environmental factors have been suggested in the pathogenesis of rheumatic diseases. We here investigated whether infections increase the risk of developing primary Sjögren's syndrome (pSS). METHODS: Patients with pSS in Sweden (n = 945) and matched controls from the general population (n = 9048) were included, and data extracted from the National Patient Register to identify infections occurring before pSS diagnosis during a mean observational time of 16.0 years. Data were analysed using conditional logistic regression models. Sensitivity analyses were performed by varying exposure definition and adjusting for previous health care consumption. RESULTS: A history of infection associated with an increased risk of pSS (OR 1.9, 95% CI 1.6-2.3). Infections were more prominently associated with the development of SSA/SSB autoantibody-positive pSS (OR 2.7, 95% CI 2.0-3.5). When stratifying the analysis by organ system infected, respiratory infections increased the risk of developing pSS, both in patients with (OR 2.9, 95% CI 1.8-4.7) and without autoantibodies (OR 2.1, 95% CI 1.1-3.8), whilst skin and urogenital infections only significantly associated with the development of autoantibody-positive pSS (OR 3.2, 95% CI 1.8-5.5 and OR 2.7, 95% CI 1.7-4.2). Furthermore, a dose-response relationship was observed for infections and a risk to develop pSS with Ro/SSA and La/SSB antibodies. Gastrointestinal infections were not significantly associated with a risk of pSS. CONCLUSIONS: Infections increase the risk of developing pSS, most prominently SSA/SSB autoantibody-positive disease, suggesting that microbial triggers of immunity may partake in the pathogenetic process of pSS.

Occurrence of occult CSF leaks during standard FESS procedures.

OBJECTIVE: To determine the incidence of occult cerebrospinal fluid leaks (CSF) after functional endoscopic sinus surgery (FESS) and to evaluate the diagnostic performance of beta2-transferrin in blood-contaminated conditions. STUDY DESIGN: Prospective cohort study. METHODS: An analysis of 57 intraoperative samples using hydrogel 6 beta2-transferrin assay after FESS was undertaken. In case of CSF positive samples and continuing rhinorrhea, reanalysis after more than 1 year was conducted. In-vivo analysis of a primary spontaneous CSF leak sample took place to verify difficulties in detecting beta2-transferrin in blood-contaminated settings. Own titrations were performed to evaluate detection limits of CSF by beta2-transferrin and beta-trace protein assays in these settings. RESULTS: An incidence of 13% for occult CSF leaks after FESS was found. In blood-contaminated conditions, routine beta2-transferrin assays showed low sensitivity. In over 1 year follow-up, all samples were negative for CSF and none of them developed clinical relevant CSF leaks or meningitis. CONCLUSION: Occult and clinically irrelevant CSF leaks do occur in a significant proportion of patients during and shortly after FESS. Intra- and postoperatively, routine beta2-transferrin assays show low sensitivity. They should not be used in these settings. The clinical course of patients with occult CSF leaks indicated possibility of an uneventful follow-up.

Relationship between achieved personalized glycaemic targets and monitoring of clinical events in elderly diabetic patients.

AIM: Recent guidelines for the management of type 2 diabetes (T2DM) in the elderly recommend adjusting the therapeutic target (HbA1c) according to the patient's health. Our study aimed to explore the association between achieving the recommended personalized HbA1c target and the occurrence of major clinical events under real-life conditions. METHODS: The T2DM S.AGES cohort was a prospective multicentre study into which 213 general practitioners recruited 983 non-institutionalized T2DM patients aged>65 years. The recommended personalized HbA1c targets were<7%, <8% and <9% for healthy, ill and very ill patients, respectively. Major clinical events (death from any cause, major vascular events and/or hospitalization) were recorded during the 3-year follow-up. Mixed-effects logistic regression models were used for the analyses. RESULTS: Of the 747 patients analyzed at baseline, 551 (76.8%) were at their recommended personalized HbA1c target. During follow-up, 391 patients (52.3%) experienced a major clinical event. Of the patients who did not achieve their personalized HbA1c target (compared with those who did), the risk (OR) of a major clinical event was 0.95 (95% CI: 0.69-1.31; P=0.76). The risk of death, major vascular event and hospitalization were 0.88 (95% CI: 0.40-1.94; P=0.75), 1.14 (95% CI: 0.7-1.83; P=0.59) and 0.84 (95% CI: 0.60-1.18; P=0.32), respectively. CONCLUSION: Over a 3-year follow-up period, our results showed no difference in risk of a major clinical event among patients, regardless of whether or not they achieved their personalized recommended HbA1c target. These results need to be confirmed before implementing a more permissive strategy for treating T2DM in elderly patients.

Treatment efficacy with electrochemotherapy: A multi-institutional prospective observational study on 376 patients with superficial tumors.

BACKGROUND: Cutaneous metastases represent a therapeutic challenge. An increasing body of experience suggests that electrochemotherapy (ECT) provides effective tumor control, although its evidence basis should be strengthened. METHODS: This prospective, multicenter, observational study enrolled patients with superficial metastases, who underwent ECT at 10 centers between 2008 and 2013. Outcomes included adherence to European Standard Operating Procedures of ECT (ESOPE), tumor response, local progression-free survival (LPFS), toxicity and patient-reported outcomes (PROs, EORTC QLQ-C30 plus an 8-item questionnaire). RESULTS: We enrolled 376 eligible patients. Tumor histotype distribution was as follows: melanoma, 56%; squamous cell carcinoma, 11%; Kaposi sarcoma, 11%; breast carcinoma, 8%; basal cell carcinoma, 6%; soft tissue sarcomas, 3%; others, 5%. We registered 1304 target tumors (median size 1 cm). Treatment adhered to ESOPE in 88% of patients as to the route of drug administration, and in 70% as to electrode application. The procedure was mainly performed under sedation (64.6%) and by using intravenous chemotherapy (93.4%). Tumor response rate at 60 days was 88% (complete, 50%). Small tumor size predicted complete response achievement (OR 2.24, p = 0.003), higher LPFS (HR 0.68, p = 0.004) and improved PROs (Global Health Status, p < 0.001; wound bleeding, p < 0.001; healing, p = 0.002; and aesthetics, p < 0.001). Skin toxicity (grade ≥3, 7.8%) was lower in patients with tumors <2 cm (p≤0.001). One-year LPFS was 73.7% (95%CI 68.4-78.3). CONCLUSIONS: ECT represents a valuable skin-directed therapy across a range of malignancies. The most frequently applied treatment modality is intravenous chemotherapy under sedation. Small tumor size predicts durable tumor control, fewer side-effects and better PROs.

Regional water quality patterns in an alluvial aquifer: direct and indirect influences of rivers.

The influence of rivers on the groundwater quality in alluvial aquifers can be twofold: direct and indirect. Rivers can have a direct influence via recharge and an indirect one by controlling the distribution of fine-grained, organic-carbon rich flood deposits that induce reducing conditions. These direct and indirect influences were quantified for a large alluvial aquifer on the Swiss Plateau (50km(2)) in interaction with an Alpine river using nitrate as an example. The hydrochemistry and stable isotope composition of water were characterized using a network of 115 piezometers and pumping stations covering the entire aquifer. Aquifer properties, land use and recharge zones were evaluated as well. This information provided detailed insight into the factors that control the spatial variability of groundwater quality. Three main factors were identified: (1) diffuse agricultural pollution sources; (2) dilution processes resulting from river water infiltrations, revealed by the δ(18)OH2O and δ(2)HH2O contents of groundwater; and (3) denitrification processes, controlled by the spatial variability of flood deposits governed by fluvial depositional processes. It was possible to quantify the dependence of the nitrate concentration on these three factors at any sampling point of the aquifer using an end-member mixing model, where the average nitrate concentration in recharge from the agricultural area was evaluated at 52mg/L, and the nitrate concentration of infiltrating river at approximately 6mg/L. The study shows the importance of considering the indirect and direct impacts of rivers on alluvial aquifers and provides a methodological framework to evaluate aquifer scale water quality patterns.

Commonly cited incentives in the community implementation of the emergency maternal and newborn care study in western Kenya.

BACKGROUND: Mortality of mothers and newborns is an important public health problem in low-income countries. In the rural setting, implementation of community based education and mobilization are strategies that have sought to reduce these mortalities. Frequently such approaches rely on volunteers within each community. OBJECTIVE: To assess the perceptions of the community volunteers in rural Kenya as they implemented the EmONC program and to identify the incentives that could result in their sustained engagement in the project. METHOD: A community-based cross sectional survey was administered to all volunteers involved in the study. Data were collected using a self-administered supervision tool from all the 881 volunteers. RESULTS: 881 surveys were completed. 769 respondents requested some form of incentive; 200 (26%) were for monetary allowance, 149 (19.4%) were for a bicycle to be used for transportation, 119 (15.5%) were for uniforms for identification, 88 (11.4%) were for provision of training materials, 81(10.5%) were for training in Home based Life Saving Skills (HBLSS), 57(7.4%) were for provision of first AID kits, and 39(5%) were for provision of training more facilitators, 36(4.7%) were for provision of free medication. CONCLUSION: Monetary allowances, improved transportation and some sort of identification are the main incentives cited by the respondents in this context.

Nasal reconstruction with the two stages vs three stages forehead flap. A three centres experience over ten years.

INTRODUCTION: In nasal reconstruction all anatomic layers as cover, lining, and support, have to be replaced to restore proper aesthetics. Forehead skin has been acknowledged as the best donor site to resurface the nose. Traditionally forehead flap reconstruction is performed in two stages, but Millard described an intermediate third stage between flap transfer and pedicle division. This study compared the two methods. MATERIALS AND METHODS: The study enrolled 31 patients undergoing total or subtotal nose reconstruction between January 2001 and January 2012. 20 patients underwent to the two-step technique (2S Group), and 11 the three-step technique (3S Group). Thickness of the flap was measured in three different areas. A plastic surgeon not involved in the study completed an evaluation questionnaire to assess aesthetic satisfaction (VAS = 1-10). RESULTS: The total number of procedures performed (including revisions) ranged from 3 to 6. The average number of procedures performed in group 2S patients was 4 (range: 3-6) in the group 3S was 3.46 (range: 3-5). VAS mean values were studied with t Student test and were found to be significant. DISCUSSION: The timing of thinning of the flap and detachment of the pedicle varies among Authors. There are generally two trends: defatting of the flap before the pedicle transection, performed usually 3 weeks from flap harvesting and defatting a few months after disconnection of the pedicle. We think this technique is suited for defects including underlying structures and particularly for all those defects located in the distal part of the nose (tip and nostrils).

Preoperative advantages of HF sonography of pilonidal sinus.

AIM AND METHODS: Pilonidal sinus is a not infrequent disease, probably due to a disontogenetic origin. Histologically, there is a pseudocystic formation in the subcutaneous adipose tissue, containing some hair bulbs. It usually presents a recurring inflammatory course. The pathologic formation does not normally have thick wall, being made up of thin epidermal epithelium, without internal vascularisation and with frequent subcutaneous fistulae. Even though the clinical diagnosis is rather easy, surgery may prove, on the contrary, a demanding task, with a high incidence of recurrence and complications. An adequate knowledge of the condition and its development, with a precise definition of the margins of the lesions, may simplify the surgery, reducing the chance of recurrence or complications. The use of echography in the diagnosis of this disease, in our cohort of 72 patients, has always provided valuable information. In particular, 13 and 18 MHz linear probes and 20 MHz mechanical array have been used, and the latter in particular for the evaluation of fistolous cavities/passageways under the skin. Results. In all our cases, echography has demonstrated pseudocystic formations, without real walls, with fairly high levels of internal echoes, compared to the hair follicles, or, more rarely, true macrocalcifications with one or more cavities/passageways near the skin, without internal vascularisation, according to the histological findings. Echographic data are rapidly obtained, and can prove useful for surgeons for a a better management of patients. Conclusion. We consider diagnostic echography, using high frequency probes, useful for the anatomical definition of this disease, as well as to enable better surgical management.

Effective treatment of Kaposi's sarcoma by electrochemotherapy and intravenous bleomycin administration.

The present prospective study was aimed at evaluating the long-term efficacy of local electrochemotherapy (ECT) with the intravenous administration of bleomycin, on disease progression and viral activity in classic Kaposi's sarcoma (cKS), a vascular tumor related to human herpes virus-8 infection. Eighteen patients affected by isolate or multiple cutaneous lesions, refractory to conventional treatments, although in the absence of visceral involvement, were enrolled in a study. Follow-up visits were performed after 4 weeks and every 6 months for up to 48 months. A more extensive exploration of the immunologic status as well as of virological parameters was performed in nine patients. The results showed a significant clinical improvement in all patients after 4 weeks. A complete regression was observed in 12 patients after the first ECT, while four patients required a second treatment on the residual lesions after 4 weeks from the first intervention. The positive outcome persisted during the subsequent clinical control visits. Two patients, that showed rapidly evolving did not improve and relapsed despite a second round of ECT treatment. Effective treatment was associated with the reduction of viral load to undetectable levels. These data support the conduct of larger studies directed at validating the efficacy of ECT as a first-line therapy for cKS.

Selective lymphadenectomy for penile cancer.

INTRODUCTION: Lymph node treatment in patients with penile cancer has been longly debated in the last 15 years, with surgeons advocating therapeutic lymphadenectomy and others advocating selective lymphadenectomy (SLND). MATERIALS AND METHODS: We evaluated the outcome of clinically node negative penile cancer patients treated with SLND. Since March 2000, 35 node negative penile cancer patients were operated on mainly at the Division of Plastic Surgery, San Gallicano Institute, Rome (Italy), with SLND. RESULTS: A sentinel node was detected in 34 out of 35 patients (42 groins). With a minimum of five years follow up, metastases were noted in 5 out of 35 patients. Out of the remaining 30 patients, 2 developed node metastases in the operated inguinal region (6.6%). DISCUSSION: SLND for penile cancer compared to surveillance only greatly improves survival rate and disease-free rate (91% vs 79% after 3 years follow-up). Identification of more specific markers for SCC lymph node metastases will make the false negative-rate drop further.

Cagliari University Hospital (CUH) protocol for immediate alloplastic breast reconstruction and unplanned radiotherapy. A preliminary report.

INTRODUCTION: Alloplastic breast reconstruction necessitating postmastectomy radiotherapy (PMRT) is at increased risk for complications such as capsular contracture, infection, extrusion, and poor cosmetic results. However, often the indication for PMRT is not decided until a permanent histological examination with review of the permanent sections is carried out, and the expander has already been inserted. Techniques described to face this issue (delayed-immediate reconstruction and Memorial Sloan Kettering Cancer Center protocol) both have disadvantages. MATERIALS AND METHODS: The protocol we suggest is based on (1) reconstruction with tissue expander placement at the time of mastectomy; (2) complete tissue expansion during postoperative chemotherapy; (3) radiotherapy, as suggested by oncologists; (4) two or three fat grafting session, according to Coleman's technique, 4-6 months after RT; (5) exchange of the tissue expander for a permanent implant approximately 3 months after the completion of fat grafting. Ten patients were treated according to these guidelines. RESULTS: Results at 15 months have been encouraging, with no grade 3-4 Baker's capsular contracture. DISCUSSION: Although the group of patients treated according to our CUH Protocol for immediate implant-based breast reconstruction and radiotherapy is small, and follow-up is short; nevertheless, results are encouraging.

[Radiofrequency ablation as a palliative therapy option in ENT tumors: in vivo and in vitro testing]. / Radiofrequenzablation als palliative Therapieoption bei HNO-Tumoren : In-vivo- und In-vitro-Versuche.

BACKGROUND: High frequency thermotherapy (HFTT) is an established palliative therapy for hepatic malignancies. An in vivo and in vitro trial examined the preconditions for the application of HFTT with liquid-cooled wet electrodes for minimally invasive palliation of head and neck tumors. MATERIAL AND METHOD: HFTT was applied with needle electrodes, cooled with isotonic saline solution, and a high-frequency generator (Elektrotom HiTT 106, Berchtold, Tuttlingen) to porcine tongue and narcotized, juvenile domestic pigs to the tongue and neck, and monitored in realtime by B-mode ultrasound. RESULTS: The direction of spread of the hyperthermic zone is well observed using ultrasound. Determining the direction of spread is not possible with cooled-tip electrode needles. Severe complications were not observed during the application. CONCLUSION: RFA with liquid-cooled needle applicators is not safely applicable for the therapy of head and neck tumors.

Host- rather than virus-related factors reduce health-related quality of life in hepatitis C virus infection.

BACKGROUND: Hepatitis C virus (HCV) infection is associated with decreased health-related quality of life (HRQOL). Although HCV has been suggested to directly impair neuropsychiatric functions, other factors may also play a role. PATIENTS AND METHODS: In this cross-sectional study, we assessed the impact of various host-, disease- and virus-related factors on HRQOL in a large, unselected population of anti-HCV-positive subjects. All individuals (n = 1736) enrolled in the Swiss Hepatitis C Cohort Study (SCCS) were asked to complete the Short Form 36 (SF-36) and the Hospital Anxiety Depression Scale (HADS). RESULTS: 833 patients (48%) returned the questionnaires. Survey participants had significantly worse scores in both assessment instruments when compared to a general population. By multivariable analysis, reduced HRQOL (mental and physical summary scores of SF-36) was independently associated with income. In addition, a low physical summary score was associated with age and diabetes, whereas a low mental summary score was associated with intravenous drug use. HADS anxiety and depression scores were independently associated with income and intravenous drug use. In addition, HADS depression score was associated with diabetes. None of the SF-36 or HADS scores correlated with either the presence or the level of serum HCV RNA. In particular, SF-36 and HADS scores were comparable in 555 HCV RNA-positive and 262 HCV RNA-negative individuals. CONCLUSIONS: Anti-HCV-positive subjects have decreased HRQOL compared to controls. The magnitude of this decrease was clinically important for the SF-36 vitality score. Host and environmental, rather than viral factors, seem to impact on HRQOL level.

[A case of vulvar melanoma: surgical strategy and five years follow-up]. / Un caso di melanoma vulvare: strategia chirurgica e follow-up a 5 anni.

We report a case of a woman with vulvar melanoma, arisen from a plane melanocytic lesion, extended from clitoris to the left minor labium. After diagnostic biopsy, a preoperative lymphoscintigraphy with 99m-Tc nanocolloid was performed. Surgery consisted in a radical vulvectomy, radio-controlled lymphadenectomy and vulvar reconstruction by two bilateral subgluteus soft-tissue flaps, anastomosing the urethral and vaginal stumps. Five years follow-up was negative for neoplastic recurrence.

[Merkel cell carcinoma and sentinel lymph node dissection: nine cases report]. / Carcinoma a cellule di Merkel e linfonodo sentinella: osservazioni su nove casi clinici.

Merkel cell carcinoma (MCC) is an aggressive cutaneous-neuroendocrine neoplasia with poor prognosis and high propensity for locoregional and distant metastasis. Lack of knowledge about its biological behavior, pathogenesis, and prognostic factors, complicates the prospective evaluation. Sentinel node dissection, concomitant with radical excision of the lesion, has increased in the last few years. The suitability of this technique is linked to the MCC high tendency to spread "in primis" at locoregional nodes such as other malignancies such as cutaneous melanoma. Aim of the study is the prospective evaluation of the sentinel node dissection and of the adjuvant therapies in 9 patients MCC affected. All patients, underwent evaluation and staging of the neoplasia. Diagnosis was made by excisional biopsy and histological examination. Sentinel node dissection was performed in patients without clinical locoregional metastases (8 cases). Patients with sentinel node positive for metastasis underwent radical lymphadenectomy (3 cases). One patient affected by clinically locoregional metastases had, at once, radical lymphadenectomy. Radiotherapy and/or chemotherapy as adjuvant therapy were implemented (4 cases).