Off-label prescription of psychotropic medications in a sample of Italian psychiatrists working in private practice: a cross sectional study

Background Off-label prescription refers to the use of a drug outside the terms of its Marketing Authorization. According to the literature, this practice is particularly common in clinical psychiatry. Objective To describe patterns of off-label prescription in a sample of Italian psychiatrists working in private practice. Methods An ad hoc questionnaire was developed and sent by e-mail to a sample of Italian psychiatrists working in private practice in the Region Emilia-Romagna. The questionnaire assessed frequency of off-label prescription, reasons associated with it, diagnostic categories more often associated with such practice, main sources of information used to support off-label prescription, and psychotropic agents most commonly prescribed off-label, as well as medical-legal implications. Data were analysed by means of univariate and multivariate ordered logistic regressions. Results Fifty psychiatrists (female: 44%) out of 129 who received the e-mail invitation responded (response rate: 39%). Off-label prescription was found to be inversely proportional to clinicians’ age (OR = 10.53 [95% CI 2.13-52.13]). Most commonly, second-generation antipsychotics (SGAs) were prescribed to patients diagnosed with personality disorders (PDs) (OR = 0.08 [95% CI 0.02-0.36]). A higher rate of off-label prescription was also associated to relying more on pharmaceutical sales representatives (OR = 0.58 [95%CI 0.01-0.30]) or personal professionals’ clinical experience (OR = 0.05 [95% CI 0.01-0.36]) and less on other colleagues’ experience (OR = 11.80 [95% CI 4.16-33.50]) as source of information. Conclusions Off-label prescription is common, especially among young psychiatrists, who frequently rely on previous personal clinical experience, especially when prescribing SGAs for treating patients with PDs. Respondents pointed to the need for further research and training on the topic addressed by the present study

Influence of socio-demographic features and apolipoprotein E epsilon 4 expression on the prevalence of dementia and cognitive impairment in a population of 70-74-year olds: The InveCe.Ab study

Abstract The age-specific prevalence rates of dementia vary widely. Studies focusing on specific age groups are needed to provide reliable estimates for healthcare providers and policy makers. We estimated the prevalence of dementia, dementia subtypes and cognitive impairment in "InveCe.Ab" (ClinicalTrials.gov, NCT01345110 ), a single-step multidimensional population-based study of 70–74-year olds living in Abbiategrasso (Milan, Italy). We also looked for associations with socio-demographic factors and the presence of the apolipoprotein E-ɛ4 allele. The overall dementia prevalence was 3% (95%CI: 2.1–4.1%) [Alzheimer's disease (AD): 1.2% (95%CI 0.6–1.9%); vascular dementia (VD): 1.4% (95%CI: 0.8–2.2%)]. Being single was found to be a risk factor for vascular dementia; subjects born in southern Italy were shown to be at greater risk both of overall dementia and of vascular dementia. The prevalence of cognitive impairment, with or without subjective cognitive complaints (cognitive impairment, no dementia, CIND) was 7.8% (95%CI: 6.4–9.4%). As regards the CIND subgroups, the prevalence of subjects with subjective cognitive complaints (mild cognitive impairment, MCI) was 5.0% (95%CI 3.9–6.3%), while the prevalence of those without MCI (CIND-other) was 2.8% (95%CI: 1.9–3.8). The males had a higher risk of MCI and CIND-other; the older subjects were more likely to have MCI, and those born in north-eastern Italy to have CIND-other. The prevalence of AD was higher among the apolipoprotein E-ɛ4 carriers. Our data highlight the importance of dementia and cognitive impairment in the transitional period from adulthood to old age, and reveal the presence of different associations with socio-demographic and genetic factors

Dental Health and Mortality in People With End-Stage Kidney Disease Treated With Hemodialysis: A Multinational Cohort Study

Background Dental disease is more extensive in adults with chronic kidney disease, but whether dental health and behaviors are associated with survival in the setting of hemodialysis is unknown. Study Design Prospective multinational cohort. Setting & Participants 4,205 adults treated with long-term hemodialysis, 2010 to 2012 (Oral Diseases in Hemodialysis [ORAL-D] Study). Predictors Dental health as assessed by a standardized dental examination using World Health Organization guidelines and personal oral care, including edentulousness; decayed, missing, and filled teeth index; teeth brushing and flossing; and dental health consultation. Outcomes All-cause and cardiovascular mortality at 12 months after dental assessment. Measurements Multivariable-adjusted Cox proportional hazards regression models fitted with shared frailty to account for clustering of mortality risk within countries. Results During a mean follow-up of 22.1 months, 942 deaths occurred, including 477 cardiovascular deaths. Edentulousness (adjusted HR, 1.29; 95% CI, 1.10-1.51) and decayed, missing, or filled teeth score ≥ 14 (adjusted HR, 1.70; 95% CI, 1.33-2.17) were associated with early all-cause mortality, while dental flossing, using mouthwash, brushing teeth daily, spending at least 2 minutes on oral hygiene daily, changing a toothbrush at least every 3 months, and visiting a dentist within the past 6 months (adjusted HRs of 0.52 [95% CI, 0.32-0.85], 0.79 [95% CI, 0.64-0.97], 0.76 [95% CI, 0.58-0.99], 0.84 [95% CI, 0.71-0.99], 0.79 [95% CI, 0.65-0.95], and 0.79 [95% CI, 0.65-0.96], respectively) were associated with better survival. Results for cardiovascular mortality were similar. Limitations Convenience sample of clinics. Conclusions In adults treated with hemodialysis, poorer dental health was associated with early death, whereas preventive dental health practices were associated with longer survival

Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago

Background: Literature suggests colonic resection and primary anastomosis (RPA) instead of Hartmann's procedure (HP) for the treatment of left-sided colonic emergencies. We aim to evaluate the surgical options globally used to treat patients with acute left-sided colonic emergencies and the factors that leading to the choice of treatment, comparing HP and RPA. Methods: This is a prospective, international, multicenter, observational study registered on ClinicalTrials.gov. A total 1215 patients with left-sided colonic emergencies who required surgery were included from 204 centers during the period of March 1, 2020, to May 31, 2020. with a 1-year follow-up. Results: 564 patients (43.1%) were females. The mean age was 65.9 ± 15.6 years. HP was performed in 697 (57.3%) patients and RPA in 384 (31.6%) cases. Complicated acute diverticulitis was the most common cause of left-sided colonic emergencies (40.2%), followed by colorectal malignancy (36.6%). Severe complications (Clavien-Dindo ≥ 3b) were higher in the HP group (P < 0.001). 30-day mortality was higher in HP patients (13.7%), especially in case of bowel perforation and diffused peritonitis. 1-year follow-up showed no differences on ostomy reversal rate between HP and RPA. (P = 0.127). A backward likelihood logistic regression model showed that RPA was preferred in younger patients, having low ASA score (≤ 3), in case of large bowel obstruction, absence of colonic ischemia, longer time from admission to surgery, operating early at the day working hours, by a surgeon who performed more than 50 colorectal resections. Conclusions: After 100 years since the first Hartmann's procedure, HP remains the most common treatment for left-sided colorectal emergencies. Treatment's choice depends on patient characteristics, the time of surgery and the experience of the surgeon. RPA should be considered as the gold standard for surgery, with HP being an exception

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Very late recurrence of an apparently benign pheochromocytoma

Pheochromocytoma is a tumor that has the probability to relapse in about 10% of surgically treated cases. Currently, the only recognized criteria of malignancy in these neoplasms are the evidence of metastasis at non-chromaffin sites. No reliable clinical or histopathological parameter has been, so far, identified to predict malignancy in patients with diagnosis of primary pheochromocytoma. Several authors has attempted to propose morphologic features to detect potentially malignant pheochromocytomas, but there are still too many reported cases of recurrence, also after decades, in tumors that, according to the current knowledge, are considered "benign". Here we report a case of recurrence, after 25 years, of a pheochromocytoma that had not enough criteria to be considered as malignant

The implication of liquid biopsies to predict chemoresistance in pancreatic cancer

Pancreatic cancer is one of the most aggressive diseases among solid tumors. Most patients are diagnosed with advanced or metastatic disease and are characterized by poor chemosensitivity. Therefore, earlier diagnosis and novel therapeutic possibilities for pancreatic cancer patients are urgently needed. Liquid biopsy is an emerging technology that allows the noninvasive sampling of tumor material. Nowadays, liquid biopsy has shown promising results as diagnostic, prognostic and predictive biomarkers, but it has not yet been universally adopted into regular use by clinicians. In this review, we describe different components of liquid biopsy, especially circulating tumor cells, circulating tumor DNA and exosomes and their potential clinical utility for pancreatic cancer patients