Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

<p>Abstract</p> <p>Background</p> <p>Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life.</p> <p>Methods/design</p> <p>In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described.</p> <p>Conclusion</p> <p>The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life.</p> <p>Trial Registration Number</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2579">NTR2579</a></p

Significant fall in hormone replacement therapy prescription in general practice

Background: Hormone replacement therapy (HRT) in the past has been used in one of five women but not without significant short-term and long-term consequences. Objective: The aim of the study is to assess the prescription of HRT in general practice to women consulting with menopausal symptoms, before and after publication of the Women's Health Initiative (WHI) study (2002), the Million Women Study and the Lancet Editorial (2003), and to correlate these with co-morbidity, co-medication and frequency of GP consultation. Methods: The study was performed using data collected by a Dutch Continuous Morbidity Registration. We selected women who presented with menopausal symptoms for the first time during the period 1999-2007 (n = 341). Women who were prescribed HRT between 2002 and 2007 were compared with women presenting with menopausal symptoms without HRT prescription and women who did not consult for menopausal symptoms. Both control groups were matched for age, socio-economic status and general practice. Results: HRT prescription decreased considerably: from 37% in all women who present with menopausal symptoms at the GP 2002 to 14% in 2003 and 4% in 2004. Women who consulted for menopausal symptoms, irrespective of HRT prescription, presented with nervous functional complaints more often, were prescribed more tranquillizers and visited the GP more frequently than women who did not consult for menopausal symptoms. Conclusions: These GPs were very quick to implement new recommendations on HRT prescription. The decision to prescribe HRT was not correlated with specific emotional or psychiatric problems of the menopausal women

2014 | Giving up Crime: Daily-life emotional experience and perceived support in detainees participating in the rehabilitation program ‘Giving up Crime’ (Kiezen voor Verandering) (conference poster, 2014)

The person centered method Giving up Crime (GUC) promotes recovery and desistance from crime in (ex)detainees by capitalizing on personal strengths and stimulating intrinsic goal restructuring. Although GUC is positively evaluated by detainees and prison officers, insight in the mechanisms underlying these appraisals is scant. This study investigates the effects of GUC on detainees´ emotional experience and perceived levels of support in the realm of daily life. (study was performed with permission of The Dutch Custodial Institutions Agency - DJI

Comparative Study of Paraneoplastic and Nonparaneoplastic Autoimmune Encephalitis With GABA_BR Antibodies

BACKGROUND AND OBJECTIVES: While patients with paraneoplastic autoimmune encephalitis (AE) with gamma-aminobutyric-acid B receptor antibodies (GABABR-AE) have poor functional outcomes and high mortality, the prognosis of nonparaneoplastic cases has not been well studied. METHODS: Patients with GABABR-AE from the French and the Dutch Paraneoplastic Neurologic Syndromes Reference Centers databases were retrospectively included and their data collected; the neurologic outcomes of paraneoplastic and nonparaneoplastic cases were compared. Immunoglobulin G (IgG) isotyping and human leukocyte antigen (HLA) genotyping were performed in patients with available samples. RESULTS: A total of 111 patients (44/111 [40%] women) were enrolled, including 84 of 111 (76%) paraneoplastic and 18 of 111 (16%) nonparaneoplastic cases (cancer status was undetermined for 9 patients). Patients presented with seizures (88/111 [79%]), cognitive impairment (54/111 [49%]), and/or behavioral disorders (34/111 [31%]), and 54 of 111 (50%) were admitted in intensive care unit (ICU). Nonparaneoplastic patients were significantly younger (median age 54 years [range 19-88] vs 67 years [range 50-85] for paraneoplastic cases, p &lt; 0.001) and showed a different demographic distribution. Nonparaneoplastic patients more often had CSF pleocytosis (17/17 [100%] vs 58/78 [74%], p = 0.02), were almost never associated with KTCD16-abs (1/16 [6%] vs 61/70 [87%], p &lt; 0.001), and were more frequently treated with second-line immunotherapy (11/18 [61%] vs 18/82 [22%], p = 0.003). However, no difference of IgG subclass or HLA association was observed, although sample size was small (10 and 26 patients, respectively). After treatment, neurologic outcome was favorable (mRS ≤2) for 13 of 16 (81%) nonparaneoplastic and 37 of 84 (48%) paraneoplastic cases (p = 0.03), while 3 of 18 (17%) and 42 of 83 (51%) patients had died at last follow-up (p = 0.008), respectively. Neurologic outcome no longer differed after adjustment for confounding factors but seemed to be negatively associated with increased age and ICU admission. A better survival was associated with nonparaneoplastic cases, a younger age, and the use of immunosuppressive drugs. DISCUSSION: Nonparaneoplastic GABABR-AE involved younger patients without associated KCTD16-abs and carried better neurologic and vital prognoses than paraneoplastic GABABR-AE, which might be due to a more intensive treatment strategy. A better understanding of immunologic mechanisms underlying both forms is needed.</p

Qualitative study about the ways teachers react to feedback from resident evaluations

Contains fulltext : 127324.pdf (publisher's version ) (Open Access)BACKGROUND: Currently, one of the main interventions that are widely expected to contribute to teachers' professional development is confronting teachers with feedback from resident evaluations of their teaching performance. Receiving feedback, however, is a double edged sword. Teachers see themselves confronted with information about themselves and are, at the same time, expected to be role models in the way they respond to feedback. Knowledge about the teachers' responses could be not only of benefit for their professional development, but also for supporting their role modeling. Therefore, research about professional development should include the way teachers respond to feedback. METHOD: We designed a qualitative study with semi-structured individual conversations about feedback reports, gained from resident evaluations. Two researchers carried out a systematic analysis using qualitative research software. The analysis focused on what happened in the conversations and structured the data in three main themes: conversation process, acceptance and coping strategies. RESULTS: The result section describes the conversation patterns and atmosphere. Teachers accepted their results calmly, stating that, although they recognised some points of interest, they could not meet with every standard. Most used coping strategies were explaining the results from their personal beliefs about good teaching and attributing poor results to external factors and good results to themselves. However, some teachers admitted that they had poor results because of the fact that they were not "sharp enough" in their resident group, implying that they did not do their best. CONCLUSIONS: Our study not only confirms that the effects of feedback depend first and foremost on the recipient but also enlightens the meaning and role of acceptance and being a role model. We think that the results justify the conclusion that teachers who are responsible for the day release programmes in the three departments tend to respond to the evaluation results just like human beings do and, at the time of the conversation, are initially not aware of the fact that they are role models in the way they respond to feedback

A core outcome set for future endometriosis research : an international consensus development study

Objective: To develop a core outcome set for endometriosis. Design: Consensus development study. Setting: International. Population: One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives. Methods: Modified Delphi method and modified nominal group technique. Results: The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment. Conclusions: Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. Tweetable abstract: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

© 2017 British Journal of Anaesthesia Background: The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Methods: Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. Results: We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32–0.77); P\u3c0.01], but no difference in complication rates [OR 1.02 (0.88–1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62–0.92); P\u3c0.01; I2=87%] and reduced complication rates [OR 0.73 (0.61–0.88); P\u3c0.01; I2=89%). Conclusions: Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine