External validation of the Surgical Outcome Risk Tool (SORT) in 3305 abdominal surgery patients in the independent sector in the UK.

BACKGROUND: Assessing the risk of post-surgical mortality is a key component of pre-surgical planning. The Surgical Outcome Risk Tool (SORT) uses pre-operative variables to predict 30-day mortality. The aim of this study was to externally validate SORT in patients undergoing major abdominal surgery. METHODS: Data were collected from patients treated in five independent hospitals in the UK. Individualised SORT scores were calculated, and area under the receiver operating characteristic (AUROC) and precision-recall curves (PRC) plus 95% confidence intervals (CI) were drawn to test the ability of SORT to identify in-hospital death. Outcomes of patients with a SORT predicted risk of mortality of ≥ 5% (high risk) were compared to those with a predicted risk of < 5% (standard risk). RESULTS: The study population comprised 3305 patients, mean age 51 years, 2783 (84.2%) underwent elective surgery most frequently involving the colon (24.6%), or liver, pancreas or gallbladder (18.2%). Overall, 1551 (46.9%) patients were admitted to ICU and 29 (0.88%) died. The AUROC of SORT for discriminating patients at risk of death in hospital was 0.899 (95% CI 0.849 to 0.949) and the PRC 0.247. In total, 72 (2.18%) patients were stratified as high risk. There were more unplanned ICU admissions and deaths in this group compared to the standard risk group (25.0% and 3.3%, versus 3.1% and 0.5%, respectively). CONCLUSION: We externally validated SORT in a large population of abdominal surgery patients. SORT performed well in patients with lower risk profiles, but underpredicted adverse outcomes in the higher risk group.

Hyaluronic acid for treatment of the radiation therapy side effects: a systematic review.

OBJECTIVE: The main limit of radiation therapy is the dose-dependent toxicity to healthy tissues. The 36% of patients exposed to radiotherapy for pelvic malignancies reporting gastrointestinal symptoms as incontinence, pain, mucus discharge, and bleeding (radiation proctopathy). In the cervix cancer, healthy tissues exposed to radiations easily develop inflammation of vaginal mucosa, bleeding and pain and to improve these symptoms, some medical devices were developed. One of the most interesting for its features is undoubtedly the hyaluronic acid. Considering the histological similarity between the vaginal and the rectal mucosa, the application of hyaluronic acid for the radiation proctopathy represents an interesting opportunity. MATERIALS AND METHODS: We performed a literature search of MEDLINE, EMBASE, PubMed, and Research Gate for studies published up to March 2018. The following combination of medical subject headings, terms and free text words were used: 'hyaluronic acid', 'hyaluronate', 'topical application' and 'radiation proctitis'. RESULTS: After the screening of titles and abstracts, and using the established criteria, 7 studies were selected for inclusion in the systematic review. CONCLUSIONS: The clinical use of hyaluronic acid for topical administration in patients with inflammatory conditions at the level of the vaginal and anal mucosa, following radio and chemo-therapies, resulted an innovative approach to help patients in managing the AEs. Hyaluronic acid confirmed its totally safety profile and resulted effective in the inflammation decrease, improving the tissue health and the symptoms related. For all these reasons, we can easily promote the clinical application of hyaluronic acid on inflamed tissues though a substantial work is necessary to investigate more deeply the hyaluronic acid role on this context.

Effect of exogenous melatonin on mood and sleep efficiency in emergency medicine residents working night shifts.

OBJECTIVE: To determine whether melatonin taken prior to attempted daytime sleep sessions will improve daytime sleep quality, nighttime sleepiness, and mood state in emergency medicine (EM) residents, changing from daytime to nighttime work schedules. METHODS: A prospective, randomized, double-blind crossover design was used in an urban emergency department. Emergency medicine residents who worked two strings of nights, of at least three nights' duration each, and separated by at least one week of days were eligible. Subjects were randomized to receive either melatonin 1 mg or placebo, 30 to 60 minutes prior to their daytime sleep session, for three consecutive days after each night shift. Crossover to the other agent occurred during their subsequent night shifts. Objective measures of quality of daytime sleep were obtained using the Actigraph 1000. This device measures sleep motion and correlates with sleep efficiency, total sleep time, time in bed, and sleep latency. The Profile of Mood States (POMS) and the Stanford Sleepiness Scale (SSS) were also used to quantify nighttime mood and sleepiness. RESULTS: Among the 19 volunteers studied, there was no difference in sleep efficiency (91.16% vs 90.98%, NS), sleep duration (379.6 min vs 342.7 min, NS), or sleep latency (7.59 min vs 6.80 min, NS), between melatonin and placebo, respectively. In addition, neither the POMS total mood disturbance (5.769 baseline vs 12.212 melatonin vs 5.585 placebo, NS) nor the SSS (1.8846 baseline vs 2.2571 melatonin vs 2.1282 placebo, NS) demonstrated a statistical difference in nighttime mood and sleepiness between melatonin and placebo. CONCLUSIONS: There are no beneficial effects of a 1-mg melatonin dose on sleep quality, alertness, or mood state during night shift work among EM residents.

Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitics.

BACKGROUND: Treatment options for allergic rhinitis include antihistamines, decongestants, anticholinergics, cromolyn sodium and corticosteroids. As the nose is a small organ, comprising less than 1% of total body mass and surface area, it seems logical to confine treatment of rhinitis to the diseased organ. OBJECTIVE: To evaluate the effects of therapy with intranasal fluticasone propionate (FP), both on subjective symptoms and pathophysiological mechanisms, in rhinitis patients during pollen season when the patients were symptomatic. METHODS: We used a double-blind, placebo (PLA)-controlled, randomized, double dummy, parallel group study of the effect of 6 weeks treatment. The double-blind comparison was made between the following three treatments: FP aqueous nasal spray, 200 microg taken once daily, levocabastine (LEV) nasal spray, 200 microg taken twice daily and PLA nasal spray. Clinical evaluation and the levels of cells and mediators in nasal washing were performed before and after treatments. Twenty-four patients (11 men and 13 women, aged 17-50 years, mean age 30.1 +/- 8.5) with strictly seasonal allergic rhinitis to Parietaria entered the study. Clinical evaluation and the levels of inflammatory cells (eosinophils and activated eosinophils, i.e. EG2+) and their mediators (tryptase, eosinophil cationic protein, eosinophil protein X and neutrophil myeloperoxidase) in nasal-lavage were performed before and after treatments. RESULTS: Treatment with FP significantly increased, with respect to placebo, the percentage of days without sneezing (P < 0. 001), nasal blockage (P < 0.001), rhinorrhea (P < 0.001), nasal itching (P < 0.001). Furthermore, treatment with FP showed additional benefits with respect to LEV. The percentage of days without nasal blockage was significantly higher in the FP group that in the placebo group (P = 0.018). The same applied to rhinorrhea (P = 0.009). The percentages of days without sneezing and itching were instead not significantly different between the two groups. As expected, no significant differences were observed in baseline medians of the rhinitis symptom scores as well as in mean values of all mediators and eosinophils in nasal lavages of the various groups under study. After treatment the mean of subjective symptoms as well as all values in nasal lavage level fell significantly only in the FP group, whereas no significant changes were observed either in LEV or PLA groups. Accordingly, significant differences were observed at the end of the treatments between the values of fluticasone group vs LEV and PLA group values. Significant correlations between these values and symptom scores were found, according with literature data suggesting a pathogenetic role for these mediators and eosinophils in rhinitis. CONCLUSION: FP (200 microg once daily) affords a significant degree of improvement in rhinitis control during pollen season, as measured by subjective and objective parameters, compared with LEV (200 microg twice daily) and PLA. The therapeutic benefits of intranasal FP are reflected in, and may be caused by, the decrease in nasal inflammatory cells.

Interphysician variability in defining the planning target volume in the irradiation of prostate and seminal vesicles.

With the improvements in treatment accuracy the risk exists of over-reliance on the capability of the physician to estimate the extent of the tumour. We assessed the variability between six radiotherapists in defining the planning target volume (PTV) on CT slices for three prostate tumour cases. Percentage differences between measured volumes and mean values calculated for each case ranged from -53.64 to +60.48% (SD 36.00%). There is a considerable variation in delineating the PTV, both in the cranio-caudal direction and in the in-slice extension of the areas drawn on each slice (standard deviations ranged from 0.35 to 2.64 cm2). We also checked the uncertainty in the shape and position of the contours on each CT image. The analysis was performed on three slices of one test case. As we expected, the uncertainty seems largest for seminal vesicle slices and smallest for prostatic apex slices. These results endorse the need for uncertainty analysis of all departmental processes in order to define a detailed protocol and consequently to minimize the interphysician differences in PTV delineations.

Clinical application of integrated treatments in breast cancer.

In this paper we analyse the problems related to the "state of the art" in the treatment of stage I and II breast cancer which has become, in Italy too, an increasingly prominent problem: it is the most frequently diagnosed female cancer, accounting for about 45,000 new cases/year (150/100,000 women). In the last decade the approach to this disease has greatly evolved because of new surgical techniques, advances in adjuvant medical therapies, innovations in the field of radiotherapy, and wider use of biological parameters. We emphasize the emerging problem of ductal and lobular carcinoma in situ, because their biological patterns will be better identified and the related treatment extensively practiced in the next future. The innovations in surgery, which has now a less demolishing role, are reviewed focusing on the "sentinel axillary node" and the actual need for axillary dissection. In relation to chemotherapy (CT), we evaluate the role of adjuvant treatment also in node negative patients, and the impact of neoadjuvant schedules on survival and toxicity. Radiotherapy (RT) is complementary to conservative surgery, and its important role in preventing local relapse and in increasing OS (overall survival) has been established; recent and more sophisticated techniques have reduced its acute and late toxicity. We are however waiting for answers concerning the usefulness of a booster dose, the impact of RT on local relapse in DCIS, and the impact of RT to the breast regional lymph nodes on OS and disease-free survival (DFS). The optimal sequencing and timing of postoperative RT and CT are unknown, both concerning each other and surgery. Some possibilities include giving all planned CT before RT, all CT after RT, giving both concurrently, or giving a portion of CT before RT and then completing CT afterwards (sandwich technique): we analyse the advantages and the problems of these different therapeutic schedules in relation to the OS, the DFS and cosmesis. In conclusion, there are very few certainties to guide us in the clinical practice: the general feeling is that we need to collect more data on homogeneous groups of patients to better understand which are the prognostic factors we can rely on, in order to choose the best treatment strategy, and which are the optimal schedules of adjuvant treatments (CT and RT), with the aim of improving OS, DFS and cosmesis.

Radiological findings when very small lung volumes are irradiated in breast and chest wall treatment.

Acute pneumonitis following breast irradiation is a rare and transient phenomenon that can be easily managed by drugs. The aim of this study is to evaluate late sequelae on lung, after postoperative radiotherapy (RT) for breast cancer. We were concerned with investigating late radiological findings when very small lung volumes are involved in the irradiated volume. We studied 28 consecutive patients. They underwent clinical examination and all staging procedures before surgery, evaluation of pulmonary function with spirometry, postoperative chest x-ray and high resolution computed tomography (HRCT) of the lung before RT. Clinical examinations were usually performed every 3 months after RT. A second chest x-ray, HRCT and spirometry were carried out after nearly 7 months from the end of RT. We estimated the irradiated lung volume by measuring the area of the lung surface enclosed by the 50% isodose (LA50) in each profile. We found a significant correlation between LA50 and the score of radiological findings after RT. No correlations were found between other factors (i.e., adjuvant chemotherapy, age, weight, smoking) and lung fibrosis. No woman developed radiation pneumonitis syndrome or respiratory symptoms. Our results indicate that irradiation of the breast and/or chest wall is well tolerated if treatment planning is done accurately. The fibrosis likelihood is strongly correlated to the irradiated lung volume. The use of tangential fields limits radiological changes that can be detected only by HRCT examination and are not associated with clinical symptoms.

An ICRU 50 radiotherapy treatment chart.

We illustrate a radiotherapy treatment chart elaborated to fulfil the necessity for clarity in reporting information about radiotherapeutic treatment. The schematic configuration of the chart results from the experience and the cooperation of physicists, physicians and technicians, and an effort has been made to satisfy Levels 2/3 of the ICRU 50 recommendations. The chart has been divided into four sections corresponding to different kinds of information: a cover sheet, a section containing data about the treatment planning geometry and the console parameters adopted, a section showing dosimetric data, and a section showing treatment data. The chart seems to give a good level of accuracy in reporting treatment plan information.

Evaluation of most frequent errors in daily compilation and use of a radiation treatment chart.

Between 1 March and 30 April (1994) we recorded the errors detected by the physician, the radiographer or the physicist during prescription, preparation and execution phases of 227 treatment plans. The radiation treatment modalities used were the following: (i) single or opposed fields, moulded or not; and (ii) multiple fields or kinetic techniques. The total number of sessions performed is 1613 with the cobalt unit and 2131 with the linear accelerator (total, 3744). The total number of wrong data is 155, consisting of 24/227 (10.5%) in compilation, 22/3744 (0.58%) in execution and 109/3744 (2.9%) in registration phases. The number of missing data is 140, consisting of 10/227 (4.4%) in compilation, 9/3744 (0.2%) in execution and 121/3744 (3.2%) in registration phases. Wrong data of compilation, even if in high rate (10.5%), were all found during the same compilation phase or at the first treatment, so that they did not alter the exactness of the treatment plan. Wrong and missing data, found in the registration phase (2.9% and 3.2%, respectively), depend on the repetition of daily treatment and on the registration of data on the chart after having digitized them on the display.

[Comparison of transcutaneous radiotherapy and cordectomy in the treatment of T1a glottic carcinoma]. / Confronto tra radioterapia transcutanea e cordectomia nel trattamento del carcinoma glottico T1a.

770 patients affected by squamous cell carcinoma of the vocal cords, classified as T1a (U.I.C.C. TNM - P978) were studied retrospectively by the Head and Neck Oncology Cooperative Group. Several such studies have demonstrated the substantial equality of results, in terms of survival, obtained by the two common therapeutic approaches (radiotherapy and cordectomy). On the other hand, from a functional point of view, radiotherapy undoubtedly offers the best outcome. Site of origin has never been considered a possible prognostic factor for such cordal neoplasms; such factors could possibly make the choice between treatments significant. Therefore, the present study evaluated tumors, separating them by the anterior, middle and posterior third of the vocal cord and taking into consideration local check-up as a function of therapy. Local check-up, in terms of Relapse Free Survival (R.F.S.) was 83% at 10 years and no significant difference was observed between the different treatment modalities. Moreover, the site of origin did not appear relevant to prognosis. More accurate and prospective studies should be encouraged so as to assess the value of such data.

[Results of radiotherapy of carcinomas of the retromolar trigone observed at the Varese Regional Hospital]. / Risultati della radioterapia dei carcinomi del trigono retromolare osservati presso l'Ospedale Multizonale di Varese.

Retromolar Trigone Carcinomas (RTC) are generally diagnosed at an advanced stage in spite of their accessible location. From December 1979 to January 1987 we examined 23 patients with RTC at the Varese Regional Hospital--three women and 20 men, with an average age of 62.9 years. 21/23 patients were heavy cigarette smokers and consumed more than 1 l of alcohol per day. The patients were classified as 1 T1, 9 T2, 9 T3 and 4 T4 on the basis of TNM classification of malignant tumors. At the beginning of the treatment 12 patients had latero-cervical metastatic nodes. Fifteen patients underwent radiotherapy with 60Co with doses ranging from 60 to 70 Gy. The patients without evident metastatic cervical nodes were also irradiated with doses of at least 45 Gy as a precautionary measure. The percentage of cumulative survival of these patients amounts to 41.1% after 3 years, while for relapse-free patients pcs amounts to 40.7% after 3 years. In view of our results, we do not consider radiotherapy alone an effective treatment as a local cure for RTC. We intend to set up a new therapeutic protocol which incorporates surgery with radiotherapy and includes chemotherapy as necessary on the basis of T volume and of the presence of loco-regional metastatic nodes.

[Results of radiotherapy of supraglottic laryngeal carcinomas observed at the Division of Radiotherapy of the District Hospital of Varese]. / Risultati della radioterapia dei carcinomi laringei sovraglottici osservati presso la Divisione di Radioterapia dell'Ospedale di Circolo di Varese.

The authors review the supraglottic laryngeal carcinomas examined in the Radiotherapy Department of the "Ospedale Regionale" of Varese, Italy, from 1979 to 1984. 255 patients have been monitored: 80 considered for radiotherapy alone and 77 for postoperatory radiotherapy treatment. The cumulative actuarial survival (pcs) after 60 months, for patients treated only with radiotherapy, is 0.66 +/- e.s. 0.07; for patients treated with post-operatory radiotherapy the cumulative actuarial survival (pcs) after 60 months is 0.49 +/- e.s. 0.11. The irradiation techniques are described and the results achieved fully discussed.

[Initial therapeutic evaluations of 141 patients with carcinoma of the breast under 40 years of age]. / Prime valutazioni terapeutiche su 141 pazienti affette da carcinoma della mammella con età inferiore a 40 anni.

The Authors, considering 141 cases of patient women under 40, suffering from breast cancer, analyse the prognostic factors in relation to the different therapeutical approach, histologic type, dimensions of T, and presence or absence of metastases at the axillary lymph nodes. They, moreover, appraise the actuarial global survival with no disease (NED) of this group of patients as compared with the survival of women in more advanced age.

[Distribution of dosage and estimation of dosage absorbed by critical organs in the fields of irradiation of lymphomas]. / Distribuzione della dose e stima della dose assorbita in organi critici nei campi di irradiazione dei linfomi.

Dose distribution in blanket irradiation was determined using the photodensitometer in a life-size dummy; doses in critical tissues (especially heart, spinal cord, bone marrow) are discussed with reference to likely biological risks.