Jannah Baker

Improved surgical safety after laparoscopic compared to open surgery for apparent early stage endometrial cancer: Results from a randomised controlled trial

AIM To compare Total Laparoscopic Hysterectomy (TLH) and Total Abdominal Hysterectomy (TAH) with regard to surgical safety. METHODS Between October 2005 and June 2010, 760 patients with apparent early stage endometrial cancer were enroled in a multicentre, randomised clinical trial (LACE) comparing outcomes following TLH or TAH. The main study end points for this analysis were surgical adverse events (AE), hospital length of stay, conversion from laparoscopy to laparotomy, including 753 patients who completed at least 6 weeks of follow-up. Postoperative AEs were graded according to Common Toxicity Criteria (V3), and those immediately life-threatening, requiring inpatient hospitalisation or prolonged hospitalisation, or resulting in persistent or significant disability/incapacity were regarded as serious AEs. RESULTS The incidence of intra-operative AEs was comparable in either group. The incidence of post-operative AE CTC grade 3+ (18.6% in TAH, 12.9% in TLH, p 0.03) and serious AE (14.3% in TAH, 8.2% in TLH, p 0.007) was significantly higher in the TAH group compared to the TLH group. Mean operating time was 132 and 107 min, and median length of hospital stay was 2 and 5 days in the TLH and TAH group, respectively (p<0.0001). The decline of haemoglobin from baseline to day 1 postoperatively was 2g/L less in the TLH group (p 0.006). CONCLUSIONS Compared to TAH, TLH is associated with a significantly decreased risk of major surgical AEs. A laparoscopic surgical approach to early stage endometrial cancer is safe.

Efficacy of oral or intrauterine device-delivered progestin in patients with complex endometrial hyperplasia with atypia or early endometrial adenocarcinoma: a meta-analysis and systematic review of the literature.

OBJECTIVES To investigate the efficacy of progestin treatment to achieve pathological complete response (pCR) in patients with complex atypical endometrial hyperplasia (CAH) or early endometrial adenocarcinoma (EC). METHODS A systematic search identified 3245 potentially relevant citations. Studies containing less than ten eligible CAH or EC patients in either oral or intrauterine treatment arm were excluded. Only information from patients receiving six or more months of treatment and not receiving other treatments was included. Weighted proportions of patients achieving pCR were calculated using R software. RESULTS Twelve studies met the selection criteria. Eleven studies reported treatment of patients with oral (219 patients, 117 with CAH, 102 with grade 1 Stage I EC) and one reported treatment of patients with intrauterine progestin (11 patients with grade 1 Stage IEC). Overall, 74% (95% confidence interval [CI] 65-81%) of patients with CAH and 72% (95% CI 62-80%) of patients with grade 1 Stage I EC achieved a pCR to oral progestin. Disease progression whilst on oral treatment was reported for 6/219 (2.7%), and relapse after initial complete response for 32/159 (20.1%) patients. The weighted mean pCR rate of patients with grade 1 Stage I EC treated with intrauterine progestin from one prospective pilot study and an unpublished retrospective case series from the Queensland Centre of Gynaecologic Oncology (QCGC) was 68% (95% CI 45-86%). CONCLUSIONS There is a lack of high quality evidence for the efficacy of progestin in CAH or EC. The available evidence however suggests that treatment with oral or intrauterine progestin is similarly effective. The risk of progression during treatment is small but longer follow-up is required. Evidence from prospective controlled clinical trials is warranted to establish how the efficacy of progestin for the treatment of CAH and EC can be improved further.

Risk factors to predict the incidence of surgical adverse events following open or laparoscopic surgery for apparent early stage endometrial cancer: Results from a randomised controlled trial☆

AIMS To identify risk factors for major adverse events (AEs) and to develop a nomogram to predict the probability of such AEs in patients who have surgery for apparent early stage endometrial cancer. METHODS We used data from 753 patients who were randomised to either total laparoscopic hysterectomy or total abdominal hysterectomy in the LACE trial. Serious adverse events that prolonged hospital stay or postoperative adverse events (using common terminology criteria 3+, CTCAE V3) were considered major AEs. We analysed pre-surgical characteristics that were associated with the risk of developing major AEs by multivariate logistic regression. We identified a parsimonious model by backward stepwise logistic regression. The six most significant or clinically important variables were included in the nomogram to predict the risk of major AEs within 6weeks of surgery and the nomogram was internally validated. RESULTS Overall, 132 (17.5%) patients had at least one major AE. An open surgical approach (laparotomy), higher Charlsons medical co-morbidities score, moderately differentiated tumours on curettings, higher baseline Eastern Cooperative Oncology Group (ECOG) score, higher body mass index and low haemoglobin levels were associated with AE and were used in the nomogram. The bootstrap corrected concordance index of the nomogram was 0.63 and it showed good calibration. CONCLUSIONS Six pre-surgical factors independently predicted the risk of major AEs. This research might form the basis to develop risk reduction strategies to minimise the risk of AEs among patients undergoing surgery for apparent early stage endometrial cancer.

Epidural analgesia is associated with an increased incidence of postoperative complications in patients requiring an abdominal hysterectomy for early stage endometrial cancer.

OBJECTIVE Analgesia and early quality of recovery may be improved by epidural analgesia. We aimed to assess the effect of receiving epidural analgesia on surgical adverse events and quality of life after laparotomy for endometrial cancer. METHODS Patients were enrolled in an international, multicentre, prospective randomised trial of outcomes for laparoscopic versus open surgical treatment for the management of apparent stage I endometrial cancer (LACE trial). The current analysis focussed on patients who received an open abdominal hysterectomy via vertical midline incision only (n=257), examining outcomes in patients who did (n=108) and did not (n=149) receive epidural analgesia. RESULTS Baseline characteristics were comparable between patients with or without epidural analgesia. More patients without epidural (34%) ceased opioid analgesia 3-5 days after surgery compared to patients who had an epidural (7%; p<0.01). Postoperative complications (any grade) occurred in 86% of patients with and in 66% of patients without an epidural (p<0.01) but there was no difference in serious adverse events (p=0.19). Epidural analgesia was associated with increased length of stay (up to 48 days compared to up to 34 days in the non-epidural group). There was no difference in postoperative quality of life up to six months after surgery. CONCLUSIONS Epidural analgesia was associated with an increase in any, but not serious, postoperative complications and length of stay after abdominal hysterectomy. Randomised controlled trials are needed to examine the effect of epidural analgesia on surgical adverse events, especially as the present data do not support a quality of life benefit with epidural analgesia.

Missing in space: an evaluation of imputation methods for missing data in spatial analysis of risk factors for type II diabetes

BackgroundSpatial analysis is increasingly important for identifying modifiable geographic risk factors for disease. However, spatial health data from surveys are often incomplete, ranging from missing data for only a few variables, to missing data for many variables. For spatial analyses of health outcomes, selection of an appropriate imputation method is critical in order to produce the most accurate inferences.MethodsWe present a cross-validation approach to select between three imputation methods for health survey data with correlated lifestyle covariates, using as a case study, type II diabetes mellitus (DM II) risk across 71 Queensland Local Government Areas (LGAs). We compare the accuracy of mean imputation to imputation using multivariate normal and conditional autoregressive prior distributions.ResultsChoice of imputation method depends upon the application and is not necessarily the most complex method. Mean imputation was selected as the most accurate method in this application.ConclusionsSelecting an appropriate imputation method for health survey data, after accounting for spatial correlation and correlation between covariates, allows more complete analysis of geographic risk factors for disease with more confidence in the results to inform public policy decision-making.

Differences in Epidural and Analgesic Use in Patients with Apparent Stage I Endometrial Cancer Treated by Open versus Laparoscopic Surgery: Results from the Randomised LACE Trial.

Objectives. We compared postoperative analgesic requirements between women with early stage endometrial cancer treated by total abdominal hysterectomy (TAH) or total laparoscopic hysterectomy (TLH). Methods. 760 patients with apparent stage I endometrial cancer were treated in the international, multicentre, prospective randomised trial (LACE) by TAH (n = 353) or TLH (n = 407) (2005–2010). Epidural, opioid, and nonopioid analgesic requirements were collected until ten months after surgery. Results. Baseline demographics and analgesic use were comparable between treatment arms. TAH patients were more likely to receive epidural analgesia than TLH patients (33% versus 0.5%, P < 0.001) during the early postoperative phase. Although opioid use was comparable in the TAH versus TLH groups during postoperative 0–2 days (99.7% versus 98.5%, P = 0.09), a significantly higher proportion of TAH patients required opioids 3–5 days (70% versus 22%, P < 0.0001), 6–14 days (35% versus 15%, P < 0.0001), and 15–60 days (15% versus 9%, P = 0.02) after surgery. Mean pain scores were significantly higher in the TAH versus TLH group one (2.48 versus 1.62, P < 0.0001) and four weeks (0.89 versus 0.63, P = 0.01) following surgery. Conclusion. Treatment of early stage endometrial cancer with TLH is associated with less frequent use of epidural, lower post-operative opioid requirements, and better pain scores than TAH.

Lower preoperative quality of life increases postoperative risk of adverse events in women with endometrial cancer: Results from the LACE trial

OBJECTIVE To examine the association between preoperative quality of life (QoL) and postoperative adverse events in women treated for endometrial cancer. METHODS 760 women with apparent Stage I endometrial cancer were randomised into a clinical trial evaluating laparoscopic versus open surgery. This analysis includes women with preoperative QoL measurements, from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, and who were followed up for at least 6 weeks after surgery (n=684). The outcomes for this study were defined as (1) the occurrence of moderate to severe adverse events within 6 months (Common Toxicology Criteria (CTC) grade≥3); and (2) any serious adverse event (SAE). The association between preoperative QoL and the occurrence of AE was examined, after controlling for baseline comorbidity and other factors. RESULTS After adjusting for other factors, odds of occurrence of AE of CTC grade≥3 were significantly increased with each unit decrease in baseline FACT-G score (OR=1.02, 95% CI 1.00-1.03, p=0.030), which was driven by physical well-being (PWB) (OR=1.09, 95% CI 1.04-1.13, p=0.0002) and functional well-being subscales (FWB) (OR=1.04, 95% CI 1.00-1.07, p=0.035). Similarly, odds of SAE occurrence were significantly increased with each unit decrease in baseline FACT-G score (OR=1.02, 95% CI 1.01-1.04, p=0.011), baseline PWB (OR=1.11, 95% CI 1.06-1.16, p<0.0001) or baseline FWB subscales (OR=1.05, 95% CI 1.01-1.10, p=0.0077). CONCLUSION Women with early endometrial cancer presenting with lower QoL prior to surgery are at higher risk of developing a serious adverse event following surgery. FUNDING Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council, Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Womens Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare, Australia; Johnson and Johnson Medical, Australia; Hunter New England Centre for Gynaecological Cancer; Genesis Oncology Trust; and Smart Health Research Grant QLD Health.

Mediation of improvements in sun protective and skin self-examination behaviours: Results from the healthy text study

Melanoma is on the rise, especially in Caucasian populations exposed to high ultraviolet radiation such as in Australia. This paper examined the psychological components facilitating change in skin cancer prevention or early detection behaviours following a text message intervention.

Spatial modelling of type II diabetes outcomes: a systematic review of approaches used

With the rising incidence of type II diabetes mellitus (DM II) worldwide, methods to identify high-risk geographical areas have become increasingly important. In this comprehensive review following Cochrane Collaboration guidelines, we outline spatial methods, outcomes and covariates used in all spatial studies involving outcomes of DM II. A total of 1894 potentially relevant citations were identified. Studies were included if spatial methods were used to explore outcomes of DM II or type I and 2 diabetes combined. Descriptive tables were used to summarize information from included studies. Ten spatial studies conducted in the USA, UK and Europe met selection criteria. Three studies used Bayesian generalized linear mixed modelling (GLMM), three used classic generalized linear modelling, one used classic GLMM, two used geographic information systems mapping tools and one compared case:provider ratios across regions. Spatial studies have been effective in identifying high-risk areas and spatial factors associated with DM II outcomes in the USA, UK and Europe, and would be useful in other parts of the world for allocation of additional services to detect and manage DM II early.

Joint modelling of potentially avoidable hospitalisation for five diseases accounting for spatiotemporal effects: A case study in New South Wales, Australia

Background Three variant formulations of a spatiotemporal shared component model are proposed that allow examination of changes in shared underlying factors over time. Methods Models are evaluated within the context of a case study examining hospitalisation rates for five chronic diseases for residents of a regional area in New South Wales: type II diabetes mellitus (DMII), chronic obstructive pulmonary disease (COPD), coronary arterial disease (CAD), hypertension (HT) and congestive heart failure (CHF) between 2001–2006. These represent ambulatory care sensitive (ACS) conditions, often used as a proxy for avoidable hospitalisations. Using a selected model, the effects of socio-economic status (SES) as a shared component are estimated and temporal patterns in the influence of the residual shared spatial component are examined. Results Choice of model depends upon the application. In the featured application, a model allowing for changing influence of the shared spatial component over time was found to have the best fit and was selected for further analyses. Hospitalisation rates were found to be increasing for COPD and DMII, decreasing for CHF and stable for CAD and HT. SES was substantively associated with hospitalisation rates, with differing degrees of influence for each disease. In general, most of the spatial variation in hospitalisation rates was explained by disease-specific spatial components, followed by the residual shared spatial component. Conclusion Appropriate selection of a joint disease model allows for the examination of temporal patterns of disease outcomes and shared underlying spatial factors, and distinction between different shared spatial factors.