Local treatment of rhabdomyosarcoma of the female genital tract: Expert consensus from the Children's Oncology Group,the European Soft-Tissue Sarcoma Group,and the Cooperative Weichteilsarkom Studiengruppe

The International Soft-Tissue Sarcoma Consortium (INSTRuCT) was founded as an international collaboration between different pediatric soft-tissue sarcoma cooperative groups (Children's Oncology Group, European Pediatric Soft-Tissue Sarcoma Group, and Cooperative Weichteilsarkom Studiengruppe). Besides other tasks, a major goal of INSTRuCT is to develop consensus expert opinions for best clinical treatment. This consensus paper for patients with rhabdomyosarcoma of the female genital tract (FGU-RMS) provides treatment recommendations for local treatment, long-term follow-up, and fertility preservation. Therefore, a review of the current literature was combined with recommendations of the treatment protocols of the appropriate clinical trials. Additionally, opinions of international FGU-RMS experts were incorporated into recommendations. Results were that the prognosis of FGU-RMS is favorable with an excellent response to chemotherapy. Initial complete surgical resection is not indicated, but diagnosis should be established properly. In patients with tumors localized at the vagina or cervix demonstrating incomplete response after induction chemotherapy, local radiotherapy (brachytherapy) should be carried out. In patients with persistent tumors at the corpus uteri, hysterectomy should be performed. Fertility preservation should be considered in all patients. In conclusion, for the first time, an international consensus for the treatment of FGU-RMS patients could be achieved, which will help to harmonize the treatment of these patients in different study groups.     

“I think I could have designed it better,but I didn’t think that it was my place”: a critical review of home modification practices from the perspectives of health and of design

Abstract

Purpose: The research presented demonstrates the disharmony between end user goals and their consideration in service outcomes within ageing-in-place and asks “what can design offer health” within this domain.

Methods: Data was collected using semi-structured interviews with various stakeholders within the context of ageing in place. All data are thematically analysed through a theoretical lens of control theory.

Results: The results demonstrate a contrast between purported patient-centred care models, and a human-centred design model. This contrast in cultures causes a disconnect between the health practitioners and the end users, with a lack of clarity about the end user's intended engagement within the modification of their environment. Consequently, the goals of older adults are inadequately represented as typical home modification design processes often fail to support the reflection of goals in practice, in turn, restricting client engagement and control. Reviewing occupational therapy practices through the critical lens of control has highlighted opportunities for service improvements.

Conclusion: The consideration of co-design methodologies within home modification design is a way to reinforce client engagement and provide better pathways for older adults to remain in control and raise acceptability of modification through a better-informed decision-making process.

• Implications for Rehabilitation

• The following points detail the implications of this research upon the rehabilitation practice and theory:

• Compliance with recommendations is deeply connected to a person’s intrinsic sense of control within the clinical decision-making process.

• Co-design practices between practitioners and clients provide and novel pathway to achieve truly person-centred care and create better service experiences and clinical outcomes.

• The human-centred design methodology is highly applicable within clinical practice and provides an opportunity for clinicians to see and learn about their patients through a holistic lens centred around goals and motivations rather than physical impairments.

• The scoping of health literacy should be inclusive of all service artefacts and touchpoints that a client may encounter throughout the entire duration of experience, this includes design artefacts such as architectural drawings and other home modification designs.

     

Safety,efficacy and toxicological evaluation of a novel,patented anti-diabetic extract of Trigonella Foenum-Graecum seed extract (Fenfuro)

Safety and anti-diabetic efficacy of a novel, proprietary Trigonella foenum-graecum seed extract [novel fenugreek extract (FE), Fenfuro?, CR0010810) enriched in furostanolic saponins (>60% w/w, HPLC) were assessed. Concerning safety, we undertook studies dealing with acute oral toxicity, 28-d sub-chronic toxicity and Ames’ bacterial reverse mutation assay that revealed no toxicity. Concerning efficacy, we examined beneficial effects of the extract on rats with type 2 diabetes (T2D). Male Sprague–Dawley rats received a high-fat diet for 2 weeks followed by streptozotocin (STZ, 35?mg/kg i.p.) to produce T2D. Seven days post-STZ, rats showing ≥300?mg/dl fasting plasma glucose level (PGL) were included in the study. FE (150- or 450- mg/kg p.o.) and glipizide (5?mg/kg p.o.) were administered once daily for 20?d and then twice daily for another 10?d (total 30?d). Blood samples were collected at 0, 10, 20 and 30?d of treatment and estimated for fasting plasma triglyceride (PTG), total cholesterol and insulin levels. After 30?d, FE and glipizide-treated diabetic animals were treated in combination with or without metformin (100?mg/kg) twice daily for another 10?d. FE did not influence body weight, feed and water intake. FE (150?mg/kg p.o.) reduced PTG levels in T2D rats by 22%, 24.6% and 29% at 10, 20 and 30?d of treatment, respectively, while glipizide (5?mg/kg p.o.) reduced the PTG levels by 57.4%, 46.2% and 39.4% at these time points. FE (450?mg/kg) treatment in STZ-induced diabetic rats produced significant hypoglycemic activity (approximately 31.5%) as compared to insulin (48.2% with 1 U/kg i.p.). FE (150?mg/kg p.o.) and metformin (100?mg/kg p.o.) combined produced significant reduction (20.7%) of PGL in T2D rats. No adverse effects were observed. We conclude after extensive in vitro and in vivo safety and efficacy studies that FE is safe and effective in treating T2D.     

Open versus robotic-assisted partial nephrectomy: a multicenter comparison study of perioperative results and complications

Purpose

To compare surgical results, morbidity and positive surgical margins rate of patients undergoing robotic partial nephrectomy (RPN) versus open partial nephrectomy (OPN).

Methods

This is an observational multicenter study promoted by the “Associazione GIovani Laparoscopisti Endoscopisti” (AGILE) no-Profit Foundation, which involved six Italian urologic centers. All clinical, surgical, and pathological variables of patients treated with OPN or RPN for renal tumors were gathered in a prospectively maintained database. Tumor nephrometry was measured with PADUA score, and complications were stratified with modified Clavien system. Differences between RPN and OPN group were assessed with univariate analysis. Perioperative variables independently associated with complications were assessed with multivariate analysis.

Results

A total of 198 and 105 patients were enrolled in OPN and RPN group, respectively. Both had similar demographics, indications to surgery, tumor nephrometry, renal function, WIT (18.7 vs. 18.2 min; p = NS), positive margin rate (5.6 vs. 5.7 %; p = NS), intraoperative complications, and postoperative medical complications. Compared to OPN, RPN group was significantly more morbid (p = 0.04), included tumors with smaller size (p = 0.002), had longer operative time (p < 0.001), lower blood loss, surgical postoperative complications (5.7 vs. 21.2 %, p < 0.001), Clavien 3–4 surgical complications (1 vs. 9.1 %, p = 0.001), and shorter hospitalization. The surgical approach resulted independently correlated with surgical complications on multivariate analysis.

Conclusion

In the present series, RPN was associated with a significant reduction of blood loss, surgical complications, including the reintervention rate for urinary fistula and postoperative bleeding, and with a shorter hospitalization.     

Outcomes of junctional ectopic tachycardia ablation in adult population—a multicenter experience

Purpose

Idiopathic junctional ectopic tachycardia (JET) is typically refractory to antiarrhythmic agents. Catheter ablation for JET is feasible but is associated with high risk of unintended atrioventricular (AV) block. There is limited data on the appropriate procedural technique and clinical outcomes with catheter ablation for idiopathic JET in adults.

Methods

This is a multicenter, retrospective study of all adult patients (age?≥?18 years) who underwent catheter ablation for idiopathic JET. Patient, procedural characteristics, and long-term outcomes were evaluated.

Results

Fifteen patients [radiofrequency ablation (RF)?=?14 and cryoablation?=?1) were treated with catheter ablation. The median age was 58 years with 67% males. All patients underwent mapping of the right atrium and the aortic cusps prior to energy delivery. The location of earliest activation in relation to the atrioventricular (AV) node was postero-superior in 73% (11/15), posterior in 13% (2/15), and superior in 13% (2/15) respectively. Acute success was 100%. Arrhythmia recurrence occurred in 53% (8/15) all of whom underwent a repeat ablation. High-grade AV block requiring permanent pacemaker occurred in 20% (3/15). At 12-month follow-up in the redo-ablation group, 37.5% (3/8) had recurrence of the arrhythmia two of which underwent a third ablation procedure.

Conclusion

Catheter ablation of idiopathic JET in adults is associated with a high rate of recurrence requiring multiple procedures and high risk of AV block requiring a permanent pacemaker. Mapping and ablation of the non-coronary cusp can be considered as the arrhythmia was controlled in 3 patients with no inadvertent AV block.