A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study.

Proteus Donna is a randomised controlled trial aimed at prospectively evaluating screening with digital breast tomosynthesis (DBT), including interval cancer detection (ICD) and cancer detection (CD) in the analysis as a cumulative measure over subsequent screening episodes. Consenting women aged 46 to 68 attending the regional Breast Screening Service were randomly assigned to conventional digital mammography (DM, control arm) or DBT in addition to DM (DBT, study arm). At the subsequent round all participants underwent DM. Thirty-six months follow-up allowed for the identification of cancers detected in the subsequent screening and interscreening interval. Relative risk (RR) and 95% confidence interval (95% CI) were computed. Cumulative CD and Nelson-Aalen incidence were analysed over the follow-up period. Between 31 December 2014 and 31 December 2017, 43 022 women were randomised to DM and 30 844 to DBT. At baseline, CD was significantly higher (RR: 1.44, 95% CI: 1.21-1.71) in the study arm. ICD did not differ significantly between the two arms (RR: 0.92, 95% CI: 0.62-1.35). At subsequent screening with DM, the CD was lower (nearly significant) in the study arm (RR: 0.83, 95% CI: 0.65-1.06). Over the follow-up period, the cumulative CD (comprehensive of ICD) was slightly higher in the study arm (RR: 1.15, 95% CI: 1.01-1.31). The Nelson-Aalen cumulative incidence over time remained significantly higher in the study arm for approximately 24 months. Benign lesions detection was higher in the study arm at baseline and lower at subsequent tests. Outcomes are consistent with a lead time gain of DBT compared to DM, with an increase in false positives and moderate overdiagnosis.

The path towards herd immunity: Predicting COVID-19 vaccination uptake through results from a stated choice study across six continents.

Despite unprecedented progress in developing COVID-19 vaccines, global vaccination levels needed to reach herd immunity remain a distant target, while new variants keep emerging. Obtaining near universal vaccine uptake relies on understanding and addressing vaccine resistance. Simple questions about vaccine acceptance however ignore that the vaccines being offered vary across countries and even population subgroups, and differ in terms of efficacy and side effects. By using advanced discrete choice models estimated on stated choice data collected in 18 countries/territories across six continents, we show a substantial influence of vaccine characteristics. Uptake increases if more efficacious vaccines (95% vs 60%) are offered (mean across study areas = 3.9%, range of 0.6%-8.1%) or if vaccines offer at least 12 months of protection (mean across study areas = 2.4%, range of 0.2%-5.8%), while an increase in severe side effects (from 0.001% to 0.01%) leads to reduced uptake (mean = -1.3%, range of -0.2% to -3.9%). Additionally, a large share of individuals (mean = 55.2%, range of 28%-75.8%) would delay vaccination by 3 months to obtain a more efficacious (95% vs 60%) vaccine, where this increases further if the low efficacy vaccine has a higher risk (0.01% instead of 0.001%) of severe side effects (mean = 65.9%, range of 41.4%-86.5%). Our work highlights that careful consideration of which vaccines to offer can be beneficial. In support of this, we provide an interactive tool to predict uptake in a country as a function of the vaccines being deployed, and also depending on the levels of infectiousness and severity of circulating variants of COVID-19.

Promoting social distancing in a pandemic: Beyond good intentions.

Do reminders to promote social distancing achieve the desired effects on behavior? Much of the existing literature analyses impacts on people's intentions to comply. We run a randomised controlled trial in Denmark to test different versions of a reminder to stay home at the beginning of the crisis. Using a two-stage design, we follow up with recipients and analyse their subsequent self-reported behaviour. We find that the reminder increases ex-ante intentions to comply when it emphasises the consequences of non-compliance for the subjects themselves and their families, while it has no effect when the emphasis is on other people or the country as a whole. We also find, however, that impacts on intentions do not translate into equivalent impacts on actions. Only people in poor health react to the reminder by staying home significantly more. Our results shed light on important gaps between people's intentions and their actions in responding to the recommendations of health authorities.

Role of 0.4 % glyceryl trinitrate ointment after stapled trans-anal rectal resection for obstructed defecation syndrome: a prospective, randomized trial.

PURPOSE: The anal fissure and spasm represent possible complications and causes of postoperative anal pain in patients that have undergone stapled trans-anal rectal resection (STARR). The etiology of these complications is still questioned such as the treatment modality. This study was designed to evaluate the effectiveness of topical glyceryl trinitrate (GTN) 0.4 % in determining decrease of incidence of postoperative anal spams and fissure and reduction of early postoperative pain. METHODS: From a total of 243 patients referred for obstructed defecation syndrome (ODS) 104 (42.7 %) underwent STARR and were randomized to receive (Group 1) or not (Group 2) topical 0.4 % GTN ointment every 12 h for four postoperative weeks. Postoperative evaluation was made at 1, 6, and 12 months. RESULTS: At 1 month follow-up, the incidence of anal spasm in Groups 1 and 2 was, respectively, 0 and 14.6 % (6/41) (p = 0.010; Fisher's exact test). The incidence of anal fissure was 4/41 (9.7 %) in Group 2 and 0/44 (0 %) in Group 1 (p = 0.05; Fisher's exact test). Significant differences in median visual analogue scale score between groups were found at 1 week and 1 month follow-up (1; 0-5 vs. 2; 0-7: p = 0.0104; Mann-Whitney U test). CONCLUSION: Anal spasm and fissure may represent a cause of early postoperative anal pain in patients that have undergone STARR procedure for ODS. The use of topical GTN 0.4 % ointment in the early postoperative course seems to reduce the incidence of anal spasm and fissure and to improve the associated early postoperative pain.

Laparocopic ventral hernia repair with primary transparietal closure of the hernial defect.

BACKGROUND: The treatment of ventral hernias is still a subject of debate. The affixing of a prosthesis and the subsequent introduction of laparoscopic treatment have reduced complications and recurrences. The high incidence of seromas and high costs remain open problems. METHODS: At our Department between January 2008 and December 2011, 87 patients (43 over 65 years), out of a total of 132, with defects of wall whose major axis was less than 10 cm, or minor and multiple defects (Swiss-cheese defect) on an axis not exceeding 12 cm underwent laparoscopic ventral hernia repair (LVHR) with primary and transparietal closure of the hernial defect. Through small incisions in the skin we proceeded to close the parietal defect with sutures tied outside. Then the mesh was fixed as usual with double row of stitches and an overlap of 3-5 cm. RESULTS: In all patients, 43 of them elderly, surgery was successfully conducted. The juxtaposition of the edges of the hernial defect has not been time consuming and has not developed new complications. The postoperative course was uneventful, with discharge on the third day, except in 5 patients. Were observed only small gaps and not the formation of large seromas. There were no infections wall. We do not have relapses, but some small and asymptomatic solutions continuously up to 2 cm at the sonographic study. In elderly patients the absence of dead space and the feeling of greater stability of the wall, early mobilization and pain control have facilitated the post-operative course. CONCLUSIONS: The positioning of sutures transcutaneous is simple and effective, the reduced incidence of seromas and the greater stability of the wall suggest to adopt this procedure fully.The possibility to close the margins of the defect may allow to change the size and setting of the mesh, since the absence of dead space allows to download physiologically tensions of the wall.

Efficacy of a haemostatic matrix for the management of bleeding in patients undergoing liver resection: results from 237 cases.

BACKGROUND: The haemostatic matrix (FloSeal) is a topical agent that provides effective haemostasis in a range of surgical applications. We evaluated this sealant for intraoperative haemostatic effectiveness in an observational series of patients undergoing surgery for the resection of primary and metastatic liver tumours. METHODS: A haemostatic matrix was applied directly to areas of bleeding. The severity of bleeding before and after application was graded on a 5-point scale (0 = no bleeding, 1 = oozing, 2 = moderate blood flow, 3 = heavy blood flow, 4 = spurting blood). The time to complete haemostasis was also recorded. RESULTS: 105 women (age 61 +/- 9 years) and 132 men (age 61 +/- 12 years) were included in this study. One hundred and seventeen patients (49.36%) had pre-operative coagulopathy resulting from co-existent cirrhosis (67 Child-Pugh Class A; 50 Child-Pugh Class B). Prior to administration of a haemostatic matrix, 93 bleeding sites (24.8%) had a bleeding severity score of 2, 269 bleeding sites (71.7%) had a score of 3 and 13 bleeding sites (3.5%) had a score of 4. Following administration of the haemostatic matrix, bleeding stopped completely (score of 0) at 367 (97.9%) of the 375 sites and was reduced to a score of 1 at the remaining 8 sites (2.1%), of which only 2 were in patients with coagulopathy. The mean time to achieve haemostasis in the overall population was 2.9 +/- 1 min; this was significantly increased in patients with coagulopathy versus noncoagulopathic patients (4 +/- 1 vs. 2 +/- 1 min, p < 0.001). CONCLUSIONS: In this prospective, uncontrolled study of 237 consecutive patients undergoing major hepatic surgery to remove primary or metastatic tumours, application of a haemostatic matrix provided rapid and effective intraoperative control of mild to severe bleeding from the liver edge, even in patients with prolonged bleeding times resulting from cirrhosis. This preliminary evidence warrants a randomised, controlled clinical trial with a larger sample size.