Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016.

Quality of life (QoL) is a relevant end point and a topic of growing interest by both scientific community and regulatory authorities. Our aim was to review QoL prevalence as an end point in cancer phase III trials published in major journals and to evaluate QoL reporting deficiencies in terms of under-reporting and delay of publication. All issues published between 2012 and 2016 by 11 major journals were hand-searched for primary publications of phase III trials in adult patients with solid tumors. Information about end points was derived from paper and study protocol, when available. Secondary QoL publications were searched in PubMed. In total, 446 publications were eligible. In 210 (47.1%), QoL was not included among end points. QoL was not an end point in 40.1% of trials in the advanced/metastatic setting, 39.7% of profit trials and 53.6% of non-profit trials. Out of 231 primary publications of trials with QoL as secondary or exploratory end point, QoL results were available in 143 (61.9%). QoL results were absent in 37.6% of publications in the advanced/metastatic setting, in 37.1% of profit trials and 39.3% of non-profit trials. Proportion of trials not including QoL as end point or with missing QoL results was relevant in all tumor types and for all treatment types. Overall, 70 secondary QoL publications were found: for trials without QoL results in the primary publication, probability of secondary publication was 12.5%, 30.9% and 40.3% at 1, 2 and 3 years, respectively. Proportion of trials not reporting QoL results was similar in trials with positive results (36.5%) and with negative results (39.4%), but the probability of secondary publication was higher in positive trials. QoL is not included among end points in a relevant proportion of recently published phase III trials in solid tumors. In addition, QoL results are subject to significant under-reporting and delay in publication.

An ontogenic study of the behavioral effects of chronic intermittent exposure to ayahuasca in mice.

Ayahuasca is a beverage obtained from decoctions of the Banisteriopsis caapi plus Psychotria viridis. In religious contexts, ayahuasca is used by different age groups. However, little is known of the effects of ayahuasca during ontogenic development, particularly with regard to the functional characteristics of the central nervous system. Animal models are useful for studying the ontogenic effects of ayahuasca because they allow exclusion of the behavioral influence associated with the ritualistic use. We investigated the effects of exposure to ayahuasca (1.5 mL/kg, orally, twice a week) on memory and anxiety in C57BL/6 mice, with the post-natal day (PND) being used as the ontogenic criterion for classification: childhood (PND21 to PND35), adolescence (PND35 to PND63), adulthood (PND90-PND118), childhood-adolescence (PND21 to PND63), childhood-adulthood (PND21 to PND118) and adolescence-adulthood (PND35 to PND118). One day after the last ayahuasca exposure, the mice were subjected to the Morris water maze (MWM), open field and elevated plus maze tasks (EPM). Ayahuasca did not affect locomotion in the open field or open arms exploration in the EPM, but increased the risk assessment behavior in the childhood group. Ayahuasca did not cause any change in acquisition of spatial reference memory in the MWM task, but decreased the time spent on the platform quadrant during the test session in the adolescence group. These results suggest that, in mice, exposure to ayahuasca in childhood and adolescence promoted anxiety and memory impairment, respectively. However, these behavioral changes were not long-lasting since they were not observed in the childhood-adulthood and adolescence-adulthood groups.

[Our experience in carcinoma of the stomach (clinico-statistical contribution)]. / Nostra esperienza sul carcinoma dello stomaco (contributo clinico statistico).

The study population consisted of 168 patients suffering from gastric cancer. The authors conclude that the only way of achieving a satisfactory improvement in the long-term prognosis of this disease is by early diagnosis, greater involvement of general practitioners and rapid referral of patients to a digestive endoscopy unit.

[Long-term evaluation of the treatment of peptic ulcer by the Billroth II method]. / Valutazioni a distanza sul trattamento dell'ulcera peptica mediante resezione secondo Billroth II.

120 patients subjected to Billroth II gastrectomy over the period 1966-1982 were evaluated. The very satisfactory results obtained in our experience persuade us that this technique is still extremely valid.

[Intestinal localizations of non-Hodgkin's lymphoma (clinical and histopathologic considerations)]. / Localizzazioni intestinali del linfoma N.H. (considerazioni cliniche e istopatologiche).

The authors describe two cases of malignant lymphoma localized in the rectum and caecum respectively and, taking into account the data reported in the literature, comment on current classifications and on the latest typing methods, particularly those based on radio-immunological assay. They stress the importance of a uniform clinical classification for diagnostic and therapeutic purposes as well as the increasing amount of interest in these neoplasms, especially in relation to those carcinomas where differential diagnosis does not always prove an easy matter.

[Bilio-digestive anastomosis (our experience)]. / Le anastomosi bilio-digestive (nostra esperienza).

The authors have conducted a retrospective study of surgical therapy by bilio-digestive anastomosis of benign and malignant diseases of the common bile duct. They conclude that this procedure should only be used when the anatomical and clinical conditions do not allow other surgical techniques to be employed.

[Fournier syndrome (description of 2 clinical cases)]. / Sindrome di Fournier (descrizione di due casi clinici).

The Authors describe two cases of Fournier's syndrome, a rare disease consisting in gangrene of the scrotum, penis skin and perineum, stressing the importance of construction of an intestinal diversion for healing this unusual condition.

[The use of the Kehr tube in choledochal calculi (our experience)]. / Impiego del tubo di Kehr nella calcolosi del coledoco (nostra esperienza).

Surgical therapy of the main bile duct is an important aspect of liver disease. The authors examine the advisability of using a Kehr drain in benign and malignant disease of the main bile duct, and draw the conclusion that, with precise indications, this technique still has an important role to play in the resolution of biliary tract disease.

[Intestinal occlusion due to metastases of malignant melanoma (a clinical case)]. / Occlusione intestinale da metastasi di melanoma maligno (caso clinico).

Metastases of the gastrointestinal tract from malignant melanoma are fairly frequent, though their detection during the patient's lifetime is rare. An antemortem diagnosis, however, may not necessarily be an indication for surgery, unless in the presence of an acute complication (intestinal occlusion, perforation, or severe haemorrhage), owing to the patient's degenerated general condition, the presence of secondaries in other sites and, above all, the rare occurrence of major gastrointestinal disorders. The authors describe their experience with a patient presenting acute intestinal occlusion and operated on three years previously for malignant melanoma of the scalp.

[Follow-up clinical evaluation of raffia treatment of perforated peptic ulcer]. / Valutazioni cliniche a distanza sul trattamento con rafia dell'ulcera peptica perforata.

The authors, analysing their casuistry of 56 cases of perforated peptic ulcer, treated with simple raffia, think this surgical act, although simple, has its own therapeutical meaning in conditions of emergency such as a peritonitic abdomen. A remote checking of such patients demonstrates the validity of said therapeutical behaviour.

[Diverticulosis and diverticular disease (reference to a case of diverticular disease observed in 3 sisters)]. / Diverticolosi e malattia diverticolare (riferimento a un caso di malattia diverticolare osservato in 3 sorelle).

We started from this frequent and important intestinal pathology to emphasize the above mentioned observation of three cases where it was possible to apply three different medico-surgical techniques with excellent results.

[Current trends in malignant gastric lymphoma]. / Attuali orientamenti sui linfomi gastrici maligni.

Gastric lymphomata represent an important chapter of the oncologic pathology, for both their low incidence and the difficulties for surgeons in the preoperative recognition of such disease. The authors, after a careful study about this subject, report two cases they had the opportunity to observe.

[Stone Cone® in ureteroscopic ballistic lithotripsy of proximal ureteral stones].

Stone Cone® (Microvasive-Boston Scientific Corp, USA) is a device which prevents retrograde calculus migration during endoscopic ureterolithotripsy. We have studied the safety and efficacy of this device in endoscopic ureterolithotripsy with ballistic energy in proximal ureteral stones. MATERIALS AND METHODS. From 01/02/2006 to 01/02/2008 we carried out 36 ureterorenoscopies (URS) for proximal ureteral stones (average age: 46, range: 15-73). A ballistic energy was used for stones fragmentation. In 18 patients (Group A) we carried out URS with the aid of Stone Cone®, which was not used in the other 18 patients (Group B). Semirigid 8 Ch or 10 Ch Storz ureteroscope and ballistic lithotriptor Swiss Lithoclast Master EMS® were used. In cases of migration, edema, and ureteral damage, a ureteral stent was used. RESULTS. In Group B patients (URS performed without Stone Cone®) the migration of the whole stone, or of clinically significant fragments, occurred 8 times (45%). All of these patients underwent external shockwave lithotripsy (ESWL) at a center equipped with a lithotriptor. A ureteral stent was placed in 14 cases (78%). In Group A, the migration of a stone requiring ESWL treatment occurred only once (5%). The ureteral stent was placed 8 times (45%). We had no significant complications during the procedure. CONCLUSIONS. The Stone Cone® is a safe and easy-to-use device. The cost of this device can be balanced by the reduction of postoperative ESWL treatments for lithiasic fragments pushing up into the kidneys (p<0.01), and of ureteral stent applications at the end of the procedure (p<0.05).

[Angiomyofibroblastoma-like tumors].

Angiomyofibroblastomas are rare, benign, slow-growing tumors, that occurring predominantly in vulvar lesions of premenopausal women. In male patients only few cases are reported (angiomyofibroblastoma-like tumors). They occur mostly in scrotal and inguinal regions. We report a case of left scrotal angiomyofibroblastoma-like tumor in a 52-years old man. After a biopsy for histological examination, a complete surgical excision was performed. At 12 months' follow-up the patient is asymptomatic, and no tumor signs were was found on by abdominal computed tomography.

[Opaque arthrography in the evaluation of gonarthrosis]. / l'artrografia opaca nella valutazione della gonartrosi.

The Authors have studied, by means of the arthrographic technique, 24 cases of knee osteoarthrosis in various clinical phases. In the diagnosis of the early phases of the disease, this technique as been helpful in showing alterations, as the widening of the intercartilaginous space, the irregularities of synovial outlines, the enlargement of the normal popliteal space, which common techniques, unusually cannot display. The assay is not needed in the most advanced phases of the disease but it could here as well supply further diagnostic data (i.e. popliteal cyst, etc.). Therefore the authors suggest the arthrographic technique as a complementary assay to the roentgenological one, as well as an elective technique in the early phases of the knee osteoarthrosis.

[Chromium exposure biological indices and clinical findings in chromium plating industry (author's transl)]. / Indici biologici de esposizione al cromo e rilievi clinici nell'industria di cromatura galvanica.

According to the investigations carried out on workers of two chromium plating plants, the authors believe that chromium urinary excretion allows to determine the degree of its acute absorption. Moreover, the renal clearance of diffusible chromium allows the evaluation of chromium body burden and is related to the duration as well as to the severity of exposure. This interpretation is supported by the relation between the exposure biological indexes and the clinical and instrumental investigations which make possible the evaluation of lesions caused by chromium exposure, mostly concerning the respiratory system.