Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial.

Importance: Standard treatment for endometrial cancer involves removal of the uterus, tubes, ovaries, and lymph nodes. Few randomized trials have compared disease-free survival outcomes for surgical approaches. Objective: To investigate whether total laparoscopic hysterectomy (TLH) is equivalent to total abdominal hysterectomy (TAH) in women with treatment-naive endometrial cancer. Design, Setting, and Participants: The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was a multinational, randomized equivalence trial conducted between October 7, 2005, and June 30, 2010, in which 27 surgeons from 20 tertiary gynecological cancer centers in Australia, New Zealand, and Hong Kong randomized 760 women with stage I endometrioid endometrial cancer to either TLH or TAH. Follow-up ended on March 3, 2016. Interventions: Patients were randomly assigned to undergo TAH (n = 353) or TLH (n = 407). Main Outcomes and Measures: The primary outcome was disease-free survival, which was measured as the interval between surgery and the date of first recurrence, including disease progression or the development of a new primary cancer or death assessed at 4.5 years after randomization. The prespecified equivalence margin was 7% or less. Secondary outcomes included recurrence of endometrial cancer and overall survival. Results: Patients were followed up for a median of 4.5 years. Of 760 patients who were randomized (mean age, 63 years), 679 (89%) completed the trial. At 4.5 years of follow-up, disease-free survival was 81.3% in the TAH group and 81.6% in the TLH group. The disease-free survival rate difference was 0.3% (favoring TLH; 95% CI, -5.5% to 6.1%; P = .007), meeting criteria for equivalence. There was no statistically significant between-group difference in recurrence of endometrial cancer (28/353 in TAH group [7.9%] vs 33/407 in TLH group [8.1%]; risk difference, 0.2% [95% CI, -3.7% to 4.0%]; P = .93) or in overall survival (24/353 in TAH group [6.8%] vs 30/407 in TLH group [7.4%]; risk difference, 0.6% [95% CI, -3.0% to 4.2%]; P = .76). Conclusions and Relevance: Among women with stage I endometrial cancer, the use of total abdominal hysterectomy compared with total laparoscopic hysterectomy resulted in equivalent disease-free survival at 4.5 years and no difference in overall survival. These findings support the use of laparoscopic hysterectomy for women with stage I endometrial cancer. Trial Registration: clinicaltrials.gov Identifier: NCT00096408; Australian New Zealand Clinical Trials Registry: CTRN12606000261516.

Is it worth screening elective orthopaedic patients for carriage of Staphylococcus aureus? A part-retrospective case-control study in a Scottish hospital.

BACKGROUND: With recent focus on methicillin-resistant Staphylococcus aureus (MRSA) screening, methicillin-susceptible S. aureus (MSSA) has been overlooked. MSSA infections are costly and debilitating in orthopaedic surgery. METHODS: We broadened MRSA screening to include MSSA for elective orthopaedic patients. Preoperative decolonisation was offered if appropriate. Elective and trauma patients were audited for staphylococcal infection during 2 6-month periods (A: January to June 2013 MRSA screening; B: January to June 2014 MRSA and MSSA screening). Trauma patients are not screened presurgery and provided a control. MSSA screening costs of a modelled cohort of 500 elective patients were offset by changes in number and costs of MSSA infections to demonstrate the change in total health service costs. FINDINGS: Trauma patients showed similar infection rates during both periods (p=1). In period A, 4 (1.72%) and 15 (6.47%) of 232 elective patients suffered superficial and deep MSSA infections, respectively, with 6 superficial (2%) and 1 deep (0.3%) infection among 307 elective patients during period B. For any MSSA infection, risk ratios were 0.95 (95% CI 0.41 to 2.23) for trauma and 0.28 (95% CI 0.12 to 0.65) for elective patients (period B vs period A). For deep MSSA infections, risk ratios were 0.58 (95% CI 0.20 to 1.67) for trauma and 0.05 (95% CI 0.01 to 0.36) for elective patients (p=0.011). There were 29.12 fewer deep infections in the modelled cohort of 500 patients, with a cost reduction of £831 678 for 500 patients screened. CONCLUSIONS: MSSA screening for elective orthopaedic patients may reduce the risk of deep postoperative MSSA infection with associated cost-benefits.

Quality of life after early enteral feeding versus standard care for proven or suspected advanced epithelial ovarian cancer: Results from a randomised trial.

BACKGROUND: Malnutrition is common in patients with advanced epithelial ovarian cancer (EOC), and is associated with impaired quality of life (QoL), longer hospital stay and higher risk of treatment-related adverse events. This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL. METHODS: From 2009 to 2013, 109 patients requiring surgery for suspected advanced EOC, moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention (n=53) or control (n=56) groups. Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained. Despite being randomised to intervention, 20 patients did not receive feeds (13 did not receive the feeding tube; 7 had it removed early). Control involved postoperative diet as tolerated. QoL was measured at baseline, 6weeks postoperatively and 30days after the third cycle of chemotherapy. The primary outcome measure was the difference in QoL between the intervention and the control group. Secondary endpoints included treatment-related adverse event occurrence, length of stay, postoperative services use, and nutritional status. RESULTS: Baseline characteristics were comparable between treatment groups. No significant difference in QoL was found between the groups at any time point. There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at 7days postoperatively (11.8 intervention vs. 13.8 control, p 0.04). CONCLUSION: Early enteral feeding did not significantly improve patients' QoL compared to standard of care but may improve nutritional status.

Telephone counseling for physical activity and diet in primary care patients.

BACKGROUND: The delivery of effective interventions to assist patients to improve their physical activity and dietary behaviors is a challenge in the busy primary care setting. DESIGN: Cluster RCT with practices randomized to telephone counseling intervention or usual care. Data collection took place from February 2005 to November 2007, with analysis from December 2007 to April 2008. SETTING/PARTICIPANTS: Four-hundred thirty-four adult patients with type 2 diabetes or hypertension (mean age=58.2 [SD=11.8]; 61% female; mean BMI=31.1 [SD=6.8]) from a disadvantaged community were recruited from ten primary care practices. INTERVENTION: Twelve-month telephone counseling intervention. MAIN OUTCOME MEASURES: Physical activity and dietary intake were assessed by self-report at baseline, 4, and 12 months. RESULTS: At 12 months, patients in both groups increased moderate-to-vigorous physical activity by a mean of 78 minutes per week (SE=10). Significant intervention effects (telephone counseling minus usual care) were observed for: calories from total fat (decrease of 1.17%; p<0.007), energy from saturated fat (decrease of 0.97%; p<0.007), vegetable intake (increase of 0.71 servings; p<0.039), fruit intake (increase of 0.30 servings; p<0.001), and grams of fiber (increase of 2.23 g; p<0.001). CONCLUSIONS: The study targeted a challenging primary care patient sample and, using a telephone-delivered intervention, demonstrated modest improvements in diet and in physical activity. Results suggest that telephone counseling is a feasible means of delivering lifestyle intervention to primary care patients with chronic conditions-patients whose need for ongoing support for lifestyle change is often beyond the capacity of primary healthcare practitioners.

Competing risks models and time-dependent covariates.

New statistical models for analysing survival data in an intensive care unit context have recently been developed. Two models that offer significant advantages over standard survival analyses are competing risks models and multistate models. Wolkewitz and colleagues used a competing risks model to examine survival times for nosocomial pneumonia and mortality. Their model was able to incorporate time-dependent covariates and so examine how risk factors that changed with time affected the chances of infection or death. We briefly explain how an alternative modelling technique (using logistic regression) can more fully exploit time-dependent covariates for this type of data.

A cost-effectiveness analysis of two rehabilitation support services for women with breast cancer.

The purpose of this research was to estimate the cost-effectiveness of two rehabilitation interventions for breast cancer survivors, each compared to a population-based, non-intervention group (n = 208). The two services included an early home-based physiotherapy intervention (DAART, n = 36) and a group-based exercise and psychosocial intervention (STRETCH, n = 31). A societal perspective was taken and costs were included as those incurred by the health care system, the survivors and community. Health outcomes included: (a) 'rehabilitated cases' based on changes in health-related quality of life between 6 and 12 months post-diagnosis, using the Functional Assessment of Cancer Therapy-Breast Cancer plus Arm Morbidity (FACT-B+4) questionnaire, and (b) quality-adjusted life years (QALYs) using utility scores from the Subjective Health Estimation (SHE) scale. Data were collected using self-reported questionnaires, medical records and program budgets. A Monte-Carlo modelling approach was used to test for uncertainty in cost and outcome estimates. The proportion of rehabilitated cases was similar across the three groups. From a societal perspective compared with the non-intervention group, the DAART intervention appeared to be the most efficient option with an incremental cost of $1344 per QALY gained, whereas the incremental cost per QALY gained from the STRETCH program was $14,478. Both DAART and STRETCH are low-cost, low-technological health promoting programs representing excellent public health investments.