The value of local registry data for describing cervical cancer management and outcomes over three decades in Australia.

Registry data on invasive cervical cancers (n = 1,274) from four major hospitals (1984-2012) were analysed to determine their value for informing local service delivery in Australia. The methodology comprised disease-specific survival analyses using Kaplan-Meier product-limit estimates and Cox proportional hazards models and treatment analyses using logistic regression. Five- and 10-year survivals were 72% and 68%, respectively, equating with relative survival estimates for Australia and the USA. Most common treatments were surgery and radiotherapy. Systemic therapies increased in recent years, generally with radiotherapy, but were less common for residents from less accessible areas. Surgery was more common for younger women and early-stage disease, and radiotherapy for older women and regional and more advanced disease. The proportion of glandular cancers increased in-step with national trends. Little evidence of variation in risk-adjusted survival presented over time or by Local Health District. The study illustrates the value of local registry data for describing local treatment and outcomes. They show the lower use of systemic therapies among residents of less accessible areas which warrants further investigation. Risk-adjusted treatment and outcomes did not vary by socio-economic status, suggesting equity in service delivery. These data are important for local evaluation and were not available from other sources.

Prospective randomized trial of neoadjuvant chemotherapy during the 'wait period' following preoperative chemoradiotherapy for rectal cancer: results of the WAIT trial.

AIM: The aim was to determine whether the addition of additional cycles of chemotherapy during the 'wait period' following neoadjuvant chemoradiotherapy for rectal cancer improves the pathological complete response (pCR) rate. METHOD: Rectal cancer patients were randomly allocated either to a standard 10 week wait period before surgery (standard chemoradiotherapy, SCRT) or to receive three cycles of fluorouracil based chemotherapy following chemoradiotherapy during a similar 10 week wait (extended chemoradiotherapy, XCRT). The primary end-point was pCR as determined by blinded pathological assessment. RESULTS: Forty-nine patients were randomized (SCRTn = 24, XCRTn = 25). pCR occurred in 10 patients overall but there was no significant difference in pCR between the groups (SCRTn = 6, XCRTn = 4, P = 0.49). CONCLUSION: The addition of three cycles of 5-fluorouracil/leucovorin in a 10 week wait period after conventional chemoradiotherapy seems to result in similar pCR rates in patients with locally advanced rectal cancer based on this small randomized trial.

Low-intensity pulsed ultrasound does not influence bone healing by distraction osteogenesis: a multicentre double-blind randomised control trial.

AIMS: The aim of this double-blind prospective randomised controlled trial was to assess whether low intensity pulsed ultrasound (LIPUS) accelerated or enhanced the rate of bone healing in adult patients undergoing distraction osteogenesis. PATIENTS AND METHODS: A total of 62 adult patients undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to treatment with either an active (n = 32) or a placebo (n = 30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular Ilizarov frame was used in all patients. The rate of distraction was also standardised. The primary outcome measure was the time to removal of the frame after adjusting for the length of distraction in days/cm for both the per protocol (PP) and the intention-to-treat (ITT) groups. The assessor was blinded to the form of treatment. A secondary outcome was to identify covariates affecting the time to removal of the frame. RESULTS: There was no difference in the time to removal of the frame between the PP (difference in favour of the control group was 10.1 days/cm, 95% confidence interval (CI) -3.2 to 23.4, p = 0.054) or ITT (difference 5.0 days/cm, 95% CI -8.2 to 18.21, p = 0.226) groups. The smoking status was the only covariate which increased the time to removal of the frame (hazard ratio 0.47, 95% CI 0.22 to 0.97, p = 0.042). CONCLUSION: LIPUS does not influence the rate of bone healing in patients who undergo distraction osteogenesis. Smoking may influence bone healing. Cite this article: Bone Joint J 2017;99-B:494-502.

Negligence claims following non-union and malunion of long bone fractures: An analysis of 15 years of data.

INTRODUCTION: Non-unions and malunions are recognised to be complications of the treatment of long bone fractures. No previous work has looked at the implications of these complications from a medicolegal perspective. METHODS: A complete database of litigation claims in Trauma and Orthopaedic Surgery was obtained from the NHS Litigation Authority. Two separate modalities of the treatment of long bone fractures were examined i) non-union and ii) acquired deformity. The type of complaint, whether defended or not, and costs were analysed. RESULTS: There were claims of which 97 related to non-union and 32 related to postoperative limb deformity. The total cost was £8.2 million over a 15-year period in England and Wales. Femoral and tibial non-unions were more expensive particularly if they resulted in amputation. Rotational deformity cost nearly twice as much as angulation deformities. CONCLUSIONS: The cosmetic appearances of rotational malalignment and amputation results in higher compensation; this reinforces an outward perception of outcome as being more important than harmful effects. Notwithstanding the limitations of this database, there are clinical lessons to be gained from these litigation claims.

Medial submuscular plating of the femur in a series of paediatric patients: a useful alternative to standard lateral techniques.

We describe the technique and results of medial submuscular plating of the femur in paediatric patients and discuss its indications and limitations. Specifically, the technique is used as part of a plate-after-lengthening strategy, where the period of external fixation is reduced and the plate introduced by avoiding direct contact with the lateral entry wounds of the external fixator pins. The technique emphasises that vastus medialis is interposed between the plate and the vascular structures. A total of 16 patients (11 male and five female, mean age 9.6 years (5 to 17)), had medial submuscular plating of the femur. All underwent distraction osteogenesis of the femur with a mean lengthening of 4.99 cm (3.2 to 12) prior to plating. All patients achieved consolidation of the regenerate without deformity. The mean follow-up was 10.5 months (7 to 15) after plating for those with plates still in situ, and 16.3 months (1 to 39) for those who subsequently had their plates removed. None developed a deep infection. In two patients a proximal screw fractured without loss of alignment; one patient sustained a traumatic fracture six months after removal of the plate. Placing the plate on the medial side is advantageous when the external fixator is present on the lateral side, and is biomechanically optimal in the presence of a femoral defect. We conclude that medial femoral submuscular plating is a useful technique for specific indications and can be performed safely with a prior understanding of the regional anatomy.

Food intake increases liver stiffness measurements and hampers reliable values in patients with chronic hepatitis B and healthy controls: the PROLIFICA experience in The Gambia.

BACKGROUND: By increasing the hepatic blood circulation, food intake has been suggested to increase liver stiffness measurement (LSM) values in HCV-infected patients. AIM: To investigate prospectively the effects of food intake on LSM in hepatitis B virus (HBV)-infected patients and healthy controls. METHODS: In The Gambia, patients included in the PROLIFICA project are screened for HBV at the community level and then invited for fasting assessment including LSM. Between April 2012 and October 2012, each day, the first five participants were invited to participate in this study. After the initial examination, a standardised 850 Kcal breakfast was provided. Effect of food intake was assessed by examining mean difference of LSM, IQR and IQR/LSM at T0 (fasting LSM1), T30min (LSM2) and T120min (LSM3) respectively. RESULTS: A total of 209 subjects were enrolled in this study (133 were HBV positive, 76 healthy controls). Unreliable measurements occurred more frequently after food intake (5%, 24% and 18% at T0, T30min and T120min respectively). In both groups, median LSM2 was significantly higher than LSM1 [6.2 (IQR: 5.4, 7.9)] vs. 4.9 (4.2, 6.2), P < 0.0001. LSM3 was still higher than the baseline, but lower than LSM2. In multivariable analysis, no factor modified the effect of breakfast on LSM. In a subgroup of patients having liver biopsies, we confirmed that food intake can overestimate liver fibrosis. CONCLUSIONS: Food intake significantly increases liver stiffness measurement and its IQR values in patients with chronic hepatitis B as well as healthy individuals; and also the number of unreliable liver stiffness measurement values.

Endoscopic ultrasound guided fine needle aspiration for the diagnosis of pancreatic cystic neoplasms: a meta-analysis.

BACKGROUND AND OBJECTIVES: Mucinous cystic neoplasms and intraductal papillary mucinous tumours have greater malignant potential than serous cystic neoplasms. EUS alone is inadequate for characterising these lesions but the addition of FNA may significantly improve diagnostic accuracy. The performance of EUS-FNA is highly variable in published studies. AIM: To determine the diagnostic accuracy of EUS-FNA to differentiate mucinous versus non-mucinous cystic lesions with cyst fluid analysis for cytology and carcinoembryonic antigen (CEA) by performing a meta-analysis of published studies. METHODS: Relevant studies were identified via structured database search and included if they used a reference standard of definitive surgical histology or clinical follow-up of at least 6 months. Data from selected studies were pooled to give summary sensitivity, specificity, positive and negative likelihood ratios, diagnostic odds ratio and Receiver Operating Characteristic (ROC) curve. Pre-defined subgroup analysis was performed. RESULTS: Eighteen studies (published 2002-2011) were included, with a total of 1438 patients. For cytology, pooled sensitivity was 54(95%CI 49-59)% and specificity 93(90-95)%. The diagnostic odds ratio (DOR) was 13.3 (4.37-49.43), with I(2) of 77.1%. For CEA sensitivity was 63(59-67)% and specificity 88(83-91)%. The DOR was 10.76(6.29-18.41) with an I(2) of 25.4%. The diagnostic accuracy of EUS-FNA was enhanced in prospective studies and studies of <36 months duration. No impact of publication bias on our results was demonstrated. CONCLUSIONS: Fine-needle aspiration has moderate sensitivity but high specificity for mucinous lesions. EUS-FNA, when used in conjunction with cross sectional imaging, is a useful diagnostic tool for the correct identification of mucinous cysts.

The GOFURTGO Study: AGITG phase II study of fixed dose rate gemcitabine-oxaliplatin integrated with concomitant 5FU and 3-D conformal radiotherapy for the treatment of localised pancreatic cancer.

BACKGROUND: Locally advanced inoperable pancreatic cancer (LAPC) has a poor prognosis. By increasing intensity of systemic therapy combined with an established safe chemoradiation technique, our intention was to enhance the outcomes of LAPC. In preparation for phase III evaluation, the feasibility and efficacy of our candidate regimen gemcitabine-oxaliplatin chemotherapy with sandwich 5-fluorouracil (5FU) and three-dimensional conformal radiotherapy (3DCRT) needs to be established. METHODS: A total of 48 patients with inoperable LAPC without metastases were given gemcitabine (1000 mg m(-2) d1 + d15 q28) and oxaliplatin (100 mg m(-2) d2 + d16 q28) in induction (one cycle) and consolidation (three cycles), and 5FU 200 mg m(-2) per day over 6 weeks during 3DCRT 54 Gy. RESULTS: Median duration of sustained local control (LC) was 15.8 months, progression-free survival (PFS) was 11.0 months, and overall survival was 15.7 months. Survival rates for 1, 2, and 3 years were 70.2%, 21.3%, and 12.8%, respectively. Global quality of life did not significantly decline from baseline during treatment, which was associated with modest treatment-related toxicity. CONCLUSION: Fixed-dose gemcitabine and oxaliplatin, combined with an effective and safe regimen of 5FU and 3DCRT radiotherapy, was feasible and reasonably tolerated. The observed improved duration of LC and PFS with more intensive therapy over previous trials may be due to patient selection, but suggest that further evaluation in phase III trials is warranted.

Oncology workforce issues: the challenge of the outpatient clinic.

It is well-recognized that cancer prevalence is increasing and will continue to do so over the coming years. Adaptation of cancer services to this reality, however, has been slow. The oncology workforce, already short-staffed, will be overburdened if change does not occur in a timely manner. The results of this study seek to highlight the current workings of oncology outpatient clinics at this hospital, and to identify areas of deficiencies that need to be addressed. By presenting a portrait of our outpatient clinics, it is hoped that a discussion surrounding workforce issues can be actively engaged, as this is crucial in order to succeed in providing quality care for our cancer patients, and simultaneously to support and mentor our invaluable medical and allied health staff.

Risk of arterial thromboembolic events in patients with advanced colorectal cancer receiving bevacizumab.

BACKGROUND: Bevacizumab is an antiangiogenic mAb with efficacy against several cancers, but it is associated with risk of arterial thromboembolism (ATE). Further data are needed to determine the safety of bevacizumab. PATIENTS AND METHODS: We recorded grade 3, 4, or 5 ATE events and other data (including age, baseline cardiovascular risk factors, history of ATE, and aspirin use) from 471 patients with metastatic colorectal cancer in the MAX (Mitomycin, Avastin, Xeloda) trial of capecitabine monotherapy versus capecitabine with bevacizumab with or without mitomycin C. RESULTS: Bevacizumab-treated patients had 12 grade 3, 4, or 5 ATEs (3.8% incidence). ATEs occurred in 2.1% of patients >65 years, 5% of those with a history of ATE, and 5% of those with cardiac risk factors. Age, history of ATE, or vascular risk factors did not increase risk. Aspirin users had a higher incidence than nonusers (8.9% versus 2.7%) but had higher rates of vascular risk factors. CONCLUSIONS: Bevacizumab was associated with a modestly higher risk of ATE, but safety was not significantly worse in older patients or patients with a history of ATE or vascular risk factors. The effect of aspirin in preventing ATE in patients receiving bevacizumab could not be determined from this study.

Segmental fractures of the tibia treated by circular external fixation.

We have carried out a retrospective review of 20 patients with segmental fractures of the tibia who had been treated by circular external fixation. We describe the heterogeneity of these fractures, their association with multiple injuries and the need for multilevel stability with the least compromise of the biology of the fracture segments. The assessment of outcome included union, complications, the measurement of the functional IOWA knee and ankle scores and the general health status (Short-form 36). The mean time to union was 21.7 weeks (12.8 to 31), with no difference being observed between proximal and distal levels of fracture. Complications were encountered in four patients. Two had nonunion at the distal level, one a wire-related infection which required further surgery and another shortening of 15 mm with 8 degrees of valgus which was clinically insignificant. The functional scores for the knee and ankle were good to excellent, but the physical component score of the short-form 36 was lower than the population norm. This may be explained by the presence of multiple injuries affecting the overall score.

Correcting genu varum and genu valgum in children by guided growth: temporary hemiepiphysiodesis using tension band plates.

A total of 25 children (37 legs and 51 segments) with coronal plane deformities around the knee were treated with the extraperiosteal application of a flexible two-hole plate and screws. The mean age was 11.6 years (5.5 to 14.9), the median angle of deformity treated was 8.3 degrees and mean time for correction was 16.1 months (7 to 37.3). There was a mean rate of correction of 0.7 degrees per month in the femur (0.3 degrees to 1.5 degrees ), 0.5 degrees per month in the tibia (0.1 degrees to 0.9 degrees ) and 1.2 degrees per month (0.1 degrees to 2.2 degrees ) if femur and tibia were treated concurrently. Correction was faster if the child was under 10 years of age (p = 0.05). The patients were reviewed between six and 32 months after plate removal. One child had a rebound deformity but no permanent physeal tethers were encountered. The guided growth technique, as performed using a flexible titanium plate, is simple and safe for treating periarticular deformities of the leg.

Treatment of idiopathic club foot using the Ponseti method. Initial experience.

We report our initial experience of using the Ponseti method for the treatment of congenital idiopathic club foot. Between November 2002 and November 2004 we treated 100 feet in 66 children by this method. The standard protocol described by Ponseti was used except that, when necessary, percutaneous tenotomy of tendo Achillis were performed under general anaesthesia in the operating theatre and not under local anaesthesia in the out-patient department. The Pirani score was used for assessment and the mean follow-up time was 18 months (6 to 30). The results were also assessed in terms of the number of casts applied, the need for tenotomy of tendo Achillis and recurrence of the deformity. Tenotomy was required in 85 of the 100 feet. There was a failure to respond to the initial regimen in four feet which then required extensive soft-tissue release. Of the 96 feet which responded to initial casting, 31 (32%) had a recurrence, 16 of which were successfully treated by repeat casting and/or tenotomy and/or transfer of the tendon of tibialis anterior. The remaining 15 required extensive soft-tissue release. Poor compliance with the foot-abduction orthoses (Denis Browne splint) was thought to be the main cause of failure in these patients.

Cancer diagnosis and treatment in the Northern Territory: assessing health service performance for indigenous Australians.

Indigenous Australians with cancer are diagnosed with more advanced disease and have lower survival than other Australians. To investigate reasons for these differences. Retrospective cohort study of 1197 indigenous and nonindigenous people in the Northern Territory diagnosed with cancers of the colon and rectum, lung, breast, cervix and non-Hodgkin lymphoma between 1991 and 2000. Outcome measures were stage at diagnosis and relative risk of cancer death. Indigenous people compared with nonindigenous people had higher relative odds of advanced stage of cancer at diagnosis (relative odds 1.9, 95% CI 1.3-2.7) for four cancers but lower relative odds for lung cancer (relative odds 0.3, 95% CI 0.2-0.5). None of the potentially contributing factors examined could explain this difference. Risk of cancer death (adjusted for cancer type and age and stage at diagnosis) was higher in indigenous than in nonindigenous people (relative risk 1.7, 95% CI 1.4-2.1). This difference, however, was confined to indigenous people with an indigenous first language (relative risk 2.9, 95% CI 2.2-3.8). Adjustment for cancer treatment variables further reduced but did not eliminate this higher risk of death. Although more advanced stage at diagnosis appeared to be a sufficient explanation for poorer cancer outcome in indigenous people whose first language was English, poorer treatment also contributed to, but was still not sufficient to explain, poorer outcome in those who had an indigenous first language. Other factors, possibly including communication difficulties, knowledge of and attitudes to cancer symptoms and treatment and social and cultural 'distance' from mainstream health services, may also be involved.