Summary Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0.83, 95% CI 0.63–1.09; p=0.18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1.91, 1.06–3.44; p=0.0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0.82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0.41) and sepsis (seven [1%] vs six [1%]; p=0.79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.

Background:Female breast cancer patients with a BRCA1/2 mutation have an increased risk of contralateral breast cancer. We investigated the effect of rapid genetic counselling and testing (RGCT) on choice of surgery.Methods:Newly diagnosed breast cancer patients with at least a 10% risk of a BRCA1/2 mutation were randomised to an intervention group (offer of RGCT) or a control group (usual care; ratio 2 : 1). Primary study outcomes were uptake of direct bilateral mastectomy (BLM) and delayed contralateral prophylactic mastectomy (CPM).Results:Between 2008 and 2010, we recruited 265 women. On the basis of intention-to-treat analyses, no significant group differences were observed in percentage of patients opting for a direct BLM (14.6% for the RGCT group vs 9.2% for the control group; odds ratio (OR) 2.31; confidence interval (CI) 0.92–5.81; P=0.08) or for a delayed CPM (4.5% for the RGCT group vs 5.7% for the control group; OR 0.89; CI 0.27–2.90; P=0.84). Per-protocol analysis indicated that patients who received DNA test results before surgery (59 out of 178 women in the RGCT group) opted for direct BLM significantly more often than patients who received usual care (22% vs 9.2% OR 3.09, CI 1.15–8.31, P=0.03).Interpretation:Although the large majority of patients in the intervention group underwent rapid genetic counselling, only a minority received DNA test results before surgery. This may explain why offering RGCT yielded only marginally significant differences in uptake of BLM. As patients who received DNA test results before surgery were more likely to undergo BLM, we hypothesise that when DNA test results are made routinely available pre-surgery, they will have a more significant role in surgical treatment decisions.

Original research article IntroductIonFemale breast cancer patients who carry a BRCA1 or BRCA2 gene mutation have an increased risk of 20-55% for developing a second primary breast cancer 1 and are at increased risk for ovarian cancer. The risk of contralateral breast cancer is highest for carriers who were diagnosed with their first breast cancer at a young age. 1 Between 18 and 29% of carriers with a favorable prognosis opt for immediate or, more often, delayed contralateral prophylactic mastectomy (CPM) to reduce their risk of a second breast cancer. [2][3][4] Several studies have shown that a CPM leads to a large reduction (up to 95%) in the risk of contralateral breast cancer, with increasing evidence of improved breast cancer-specific survival. 5,6 Advances in the technology and logistics of genetic testing of the BRCA1 and BRCA2 genes have made it possible to offer high-risk breast cancer patients the opportunity to undergo rapid genetic counseling and testing (RGCT) during the time period between diagnosis and primary surgery. Women who Purpose: Female breast cancer patients carrying a BRCA1/2 mutation have an increased risk of second primary breast cancer. Rapid genetic counseling and testing (RGCT) before surgery may influence choice of primary surgical treatment. In this article, we report on the psychosocial impact of RGCT. Methods:Newly diagnosed breast cancer patients at risk for carrying a BRCA1/2 mutation were randomized to an intervention group (offer of RGCT) or a usual care control group (ratio 2:1). Psychosocial impact and quality of life were assessed with the Impact of Events Scale, Hospital Anxiety and Depression Scale, Cancer Worry Scale, and the EORTC QLQ-C30 and QLQ-BR23. Assessments took place at study entry and at 6-and 12-month follow-up visits.results: Between 2008 and 2010, 265 patients were recruited into the study. Completeness of follow-up data was more than 90%. Of the 178 women in the intervention group, 177 had genetic counseling, of whom 71 (40%) had rapid DNA testing and 59 (33%) received test results before surgery. Intention-to-treat and per-protocol analyses showed no statistically significant differences between groups over time in any of the psychosocial outcomes. conclusions:In this study, RGCT in newly diagnosed breast cancer patients did not have any measurable adverse psychosocial effects.

BackgroundTo evaluate the prognostic meaning of lymph node micrometastases in breast cancer patients.MethodsBetween January 2000 and January 2003, 1411 patients with a cT1-2N0 invasive breast carcinoma underwent surgery in 7 hospitals in the Netherlands. Sentinel lymph node biopsy was done in all patients. Based on lymph node status, patients were divided into 4 groups: pN0 (n = 922), pN1micro (n = 103), pN1a (n = 285), and pN≥1b (n = 101). Median follow-up was 6.4 years.ResultsAt the end of follow-up, 1121 women were still alive (79.4%), 184 had died (13.0%), and 106 were lost to follow-up (7.5%). Breast cancer recurred in 244 patients: distant metastasis (n = 165), locoregional relapse (n = 83), and contralateral breast cancer (n = 44). Following adjustment for possible confounding characteristics and for adjuvant systemic treatment, overall survival (OS) remained comparable for pN0 and pN1micro and was significantly worse for pN1a and pN≥1b (hazard ratio [HR] 1.18; 95% confidence interval [95% CI] 0.58–2.39, HR 2.47; 95% CI 1.69–3.63, HR 4.36; 95% CI 2.70–7.04, respectively). Disease-free survival (DFS) was similar too in the pN0 and pN1micro group, and worse for pN1a and pN≥1b (HR 0.96; 95% CI 0.56–1.67 vs HR 1.64; 95% CI 1.19–2.27, HR 2.95; CI 1.98–4.42). The distant metastases rate also did not differ significantly between the pN0 and pN1micro group and was worse for pN1a and pN≥1b (HR 1.22; 95% CI 0.60–2.49, HR 2.26; 95% CI 1.49–3.40, HR 3.49; CI 2.12–5.77).ConclusionsIn breast cancer patients survival is not affected by the presence of micrometastatic lymph node involvement.Electronic supplementary materialThe online version of this article (doi:10.1245/s10434-010-1451-z) contains supplementary material, which is available to authorized users.

Summary. We report the relative frequencies of members of the Bacteroides fragilis group in the faeces, in colon lavage fluid obtained pre-operatively, and in colonic tissue specimens obtained at operation from 10 patients with colonic cancer. B. vulgatus was the most and B. fragilis and B. ovatus were the least frequently isolated Bacteroides spp. in the faeces of the 10 subjects. B. uniformis and B. thetaiotaomicron ranked second and third in the faeces. The relative frequencies of all species except B. fragilis were lower in the lavage fluid and in cultures of mucosa. The relative frequency of B. fragilis increased from 4% in faeces to 39% in the final lavage fluid and to 42% in the colonic mucosa culture. Our results suggest that B. fragilis has a more intimate association with the gut mucosa than other members of the B. fragilis group, which might be one explanation for the high incidence of this species in gutassociated intra-abdominal infections.