Management of type 2 diabetes includes medications that can unintentionally increase obesity and insulin resistance. This unblinded, single-centre, randomised controlled trial focused on rural Australian adults with type 2 diabetes (aged 18-75 and body mass index [BMI] >30 kg/m2), measuring the effectiveness of a tailored interdisciplinary obesity care approach compared with usual diabetes care. Led by a nurse practitioner with allied health support (dietitian ± psychologist and physiotherapist), the bariatric treatment involved reducing weight-gaining medications, a 500-calories/day deficit, an unsupervised exercise program emphasising movement/strength and psychotherapy, 3-monthly to 24-months with support phone calls at weeks 2, 4, 8 and 10. Outcomes from the 224 (113 intervention/111 control) participants were differences in biomedical and physical markers within- and between-groups estimated using multivariate mixed-effects linear regression between recruitment and 6-monthly follow-ups. Greater change occurred in intervention compared with control groups at 12 and 24 months in mean: body weight (-5.9 kg [95% confidence interval, CI: -8.53, -3.23] and -9.0 kg [95% CI: -13.2, -4.77]); BMI (-2.03 kg/m2 [95% CI: -2.92, -1.15] and -3.51 kg/m2 [95% CI: -4.93, -2.08]); and glycated haemoglobin (-0.26% [95% CI: -0.69%, 0.18%] and -0.63% [95% CI: -1.17%, 0.08%]). The control group showed a significant increase in mean leptin level, resulting in a between-group difference (-27.1 [95% CI: -42.7, -11.5]). Lipids and blood pressure differences were inconclusive, while exploratory analysis showed greater decline in estimated glomerular filtration rate in the control group. The interdisciplinary obesity approach, compared with usual diabetes care, resulted in sustained weight loss and improved diabetes control over 2 years. Trial registration number: ACTRN12622000240741.

INTRODUCTION:The burden of defunctioning ileostomy is significant with up to two thirds of patients reporting stoma-related morbidity. While timely reversal is safe and cost-effective, the time to reversal in regional Australian hospitals is not well described in professional publications. We aim to assess the current timeliness of ileostomy closure and identify possible reasons for delaying closure. METHODS:A retrospective analysis of loop ileostomies created and reversed in Launceston General Hospital for both rectal cancer surgery and other benign indications was undertaken. Patients with loop ileostomy created between 2010 and 2020 were included. Clinical data of timing of events, complications, readmission and stoma follow-up were recorded; and analysed using multivariate regression analyses to identify clinically relevant risk factors for delayed closure. RESULTS:A total of 123 patients underwent loop-ileostomy formation during the study period, of which 106 patients (86.2%) were reversed. Median time to closure was 8.5 months (IQR 5.2-12.4) for patients with rectal cancers, compared to 5.2 months (IQR 3.6-9.3) for patients who did not have rectal cancer, with a difference of 3.4 months (95% CI 0.9, 5.9; P = 0.008). Adjuvant chemotherapy and unexpected readmission to hospital were associated with delayed reversal (P = 0.0081 and P = 0.0005, respectively). CONCLUSION:Stoma reversal is often scheduled 3-6 months after creation. More than two-thirds of patients experienced delays due to changing clinical concerns and non-clinical factors, such as unexpected delays at each stage of surgical planning. Early placement on the waiting list and better-coordinated follow-ups may expedite reversal surgery and reduce associated morbidities.

Background: The variability in length of the twelfth rib is mentioned in the literature but has never been formally studied. The highly variable rib length provides a challenge for urologists seeking a consistent landmark for Percutaneous Nephrolithotomy (PCNL). We set out to determine whether the twelfth rib is safe to use as a consistent landmark for surgery.Methods: Single centre, cross-sectional retrospective observational study and analysis of CT scans of 100 adults who had imaging between 23rd March and 12th April 2020. The distance from the mid-sagittal line to the twelfth rib tip in the axial plane was measured as was the distance from the twelfth rib tip to the kidney, spleen and liver.Results: Length from the mid-sagittal line to the right twelfth rib tip varied from 46 (percentile 95% CI 40 to 57) to 136mm (percentile 95% CI 133 to 138). On the left, the distances varied from 55 (percentile 95% CI 50 to 64) to 134mm (percentile 95% CI 131 to 135). Twenty-three percent of people had an organ lying between the tip of the twelfth rib and the kidney on the right and 11% on the left.Conclusion: The twelfth rib is highly variable in length. Similar variability was recorded in the distance from the tip to intra-abdominal organs. Due to the frequency of organs lying between the tip of the rib and the kidney it should not be used as a landmark for accessing the kidney without prior knowledge of an individual patient's anatomy as seen on imaging.

AIMS:Platelet-rich plasma (PRP) intra-articular injections may provide a simple and minimally invasive treatment for early-stage knee osteoarthritis (OA). This has led to an increase in its adoption as a treatment for knee OA, although there is uncertainty about its efficacy and benefit. We hypothesized that patients with early-stage symptomatic knee OA who receive multiple PRP injections will have better clinical outcomes than those receiving single PRP or placebo injections.METHODS:A double-blinded, randomized placebo-controlled trial was performed with three groups receiving either placebo injections (Normal Saline), one PRP injection followed by two placebo injections, or three PRP injections. Each injection was given one week apart. Outcomes were prospectively collected prior to intervention and then at six weeks, three months, six months, and 12 months post-intervention. Primary outcome measures were Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol five-dimension five-level index (EQ-5D-5L). Secondary outcomes included visual analogue scale for pain and patient subjective assessment of the injections.RESULTS:A total of 102 patients were recruited. The follow-up period was 12 months, at intervals of six weeks, 12 weeks, six months, and 12 months. KOOS-Total significantly improved in all groups at these time intervals compared to pre-injection. There was an improvement in EQ-5D-5L index scores in saline and single injection groups, but not in the multiple injection group. Comparison of treatment groups showed no additional beneficial effect of single or multiple PRP injections above that displayed in the saline injection group. Subjective patient satisfaction and recommendation of treatment received demonstrated a similar pattern in all the groups. There was no indication of superiority of either single or multiple PRP injections compared to saline injections.CONCLUSION:There is no evidence that single or multiple PRP had any additional beneficial effect compared to saline injection up to 12 months, follow-up after treatment of early stage symptomatic OA of the knee. Cite this article: Bone Joint J 2022;104-B(6):663-671.

Termination of pregnancy (TOP) is considered an important component of sexual and reproductive health internationally, but there are known barriers in Australia and countries worldwide. This study investigated the issues for GPs regarding aiding access to TOP and providing early medical abortion (EMA) services for Tasmanian women. Specifically, the aims of the study were to identify the knowledge and attitudes of Tasmanian GPs regarding TOP services and to determine which known barriers to providing EMA are most significant for GPs in Tasmania, Australia. A survey was developed and piloted based on previous qualitative research that identified known barriers to accessing TOP. Surveys were posted to all identified GPs in Tasmania with a reply-paid envelope. In all, 211 (27.4%) responses were returned. GPs identified difficulty accessing TOP services, particularly for rural women and those on a low income. Almost half the GPs, excluding conscientious objectors, indicated they would be interested in providing EMA services, but perceived barriers were significant. The most significant barriers related to accessing appropriate training and support. There was uncertainty around financial reward, support services, medical indemnity and access to the medical abortifacient medications mifepristone and misoprostol. In conclusion, accessing TOP remains an issue for Tasmanian women. Many Tasmanian GPs are interested in providing EMA services if barriers are addressed, but there is a lack of knowledge about the practicalities of implementing EMA. Providing practical support to GPs and increasing knowledge pertaining to EMA provision in general practice could improve access in primary care.

Maternal obesity in pregnancy, a growing health problem in Australia, adversely affects both mothers and their offspring. Gestational diabetes mellitus (GDM) is similarly associated with adverse pregnancy and neonatal complications. A low-risk digital medical record audit of antenatal and postnatal data of 2132 pregnant mothers who gave birth between 2016–2018 residing in rural-regional Tasmania was undertaken. An expert advisory group guided the research and informed data collection. Fifty five percent of pregnant mothers were overweight or obese, 43.6% gained above the recommended standards for gestational weight gain and 35.8% did not have an oral glucose tolerance test. The audit identified a high prevalence of obesity among pregnant women and low screening rates for gestational diabetes mellitus associated with adverse maternal and neonatal pregnancy outcomes. We conclude that there is a high prevalence of overweight and obesity among pregnant women in rural regional Tasmania. Further GDM screening rates are low, which require addressing.

BACKGROUND:Undergraduate medical education recognises that patient feedback is potentially valuable for student learning and development as a component of multi-source feedback. However greater exploration of how patient feedback perspectives differ to clinical educators is required for curriculum development and improving student feedback literacy. This study aimed to determine how two sources of feedback, patients and clinical tutors, compare on the same patient-centred, interpersonal criteria.METHODS:A patient feedback instrument designed for the undergraduate medical education setting was used to compare patients' feedback with clinical tutors' feedback following a student-patient consultation in the learning context. Assessments from 222 learning consultations involving 40 medical students were collected. Descriptive statistics for tutors and patients for each question were calculated and correlations between patient and tutor were explored using Spearman's rank-order correlation. Mixed effects ordered logistic regression was used to compare each question with an overall rating for tutor and patients in addition to comparing patient with tutor ratings.RESULTS:Clinical tutor and patient assessments had a weak but significant positive correlation in all areas except questions related to respect and concern. When making judgements compared with overall assessment, patients' ratings of respect, concern, communication and being understood in the consultation have a greater effect. After eliminating the effect of generally higher ratings by patients compared with tutors using comparative ordered logistic regression, patients rated students relatively less competent in areas of personal interaction.CONCLUSION:This study provides insight about patient feedback, which is required to continue improving the use and acceptability of this multisource feedback to students as a valuable component of their social learning environment. We have revealed the different perspective-specific judgement that patients bring to feedback. This finding contributes to building respect for patient feedback through greater understanding of the elements of consultations for which patients can discriminate performance.

Objectives To (1) determine whether short, 30-minute sessions of non-invasive ventilation (NIV) is associated with fewer postoperative pulmonary complications (PPC) following elective high-risk upper abdominal surgery and (2) measure feasibility and safety of this intervention when delivered by physiotherapists. Design Prospective, pre post cohort, observational, single-centre study. Setting Primary referral hospital in Australia. Participants A total of 182 consecutive high-risk elective upper abdominal surgery patients consisting of 101 pre cohort participants compared to 81 post cohort participants. Interventions Both groups received standardised preoperative physiotherapy and early postoperative mobilisation. The post cohort group received five additional 30-minute NIV sessions in the first two postoperative days. Main outcome measure Primary outcome measure was PPC incidence within the first seven postoperative days. Secondary outcomes included feasibility and safety of physiotherapy-led NIV. Results Incidence of PPC (7% vs 18%, adjusted relative risk 0.24; 95% CI 0.10 to 0.59, p = 0.002) was less in the NIV group compared to those who received no NIV. Mean time to first NIV session was 18.6 (SD 11.0) hours with 74% of participants receiving NIV within 24-hours of surgery. There were no major adverse events. Conclusion These findings suggest PPC reduction may be possible with postoperative NIV following high-risk elective upper abdominal surgery. Results should be seen as hypothesis-generating associations only considering the significant limitations to this study. Physiotherapy-led NIV was delivered safely to ICU and ward patients. However, the planned protocol was not feasible and appropriate physiotherapy staffing and/or a multidisciplinary approach may be required to provide this service successfully. Trial registration LIPPSMAck POP (Lung Infection Prevention Post Surgery – Major Abdominal – with Pre Operative Physiotherapy) ANZCTR-12613000664741 (for pre cohort group only).

QUESTION:Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?DESIGN:Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.PARTICIPANTS:Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand.INTERVENTIONS:The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only.OUTCOME MEASURES:The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months.RESULTS:Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention.CONCLUSIONS:Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation.TRIAL REGISTRATION:ACTRN12613000664741.

There is no clear consensus in the current guidelines published by major international anaesthetic associations on what is the most appropriate time for a patient to stop chewing gum. This open-label balanced-group randomised controlled trial aimed to evaluate whether the chewing of sugar-free gum caused an increased volume or reduced pH of residual gastric fluid in fasting patients. For this study 212 patients undergoing elective gastroscopy were randomised into a control group who followed routine fasting instructions and an intervention group who were asked to chew gum while fasting. Residual gastric fluid was aspirated under direct vision via a gastroscope under anaesthesia. The primary outcome was the incidence of a gastric residual volume >50 ml in participants who chewed gum compared with a control group. Secondary outcomes were variability in the overall gastric volume distribution and gastric pH distribution between the two groups. Nine out of 110 (8.2%) in the chewing gum group and six out of 102 (5.9%) in the control group had a residual gastric fluid volume >50 ml: incidence rate ratio 1.39 (95% confidence intervals (CI) 0.51–3.77; P = 0.60). However, only one patient (in the control group) had a residual gastric volume >73 ml. There was no statistically significant difference in gastric volume distribution between groups, odds ratio 1.60 (95% CI 0.99–2.58; P = 0.054) or in the distribution of gastric pH measurement, odds ratio 0.90 (95% CI 0.57–1.44; P = 0.67). These results indicate that if there is an increase in the incidence of residual gastric volume >50 ml in patients who chew gum preoperatively, it is likely to be small. Moreover, the absence of any patients in our chewing gum group with a residual gastric volume >73 ml is reassuring.

OBJECTIVES:To (1) assess memorability and treatment fidelity of pre-operative physiotherapy education prior to elective upper abdominal surgery and, (2) to explore patient opinions on pre-operative education.DESIGN:Mixed-methods analysis of a convenience sample within a larger parallel-group, double-blinded, randomised controlled trial with concealed allocation and intention-to-treat analysis.SETTING:Tertiary Australian hospital.PARTICIPANTS:Twenty-nine patients having upper abdominal surgery attending pre-admission clinic within six-weeks of surgery.INTERVENTION:The control group received an information booklet about preventing pulmonary complications with early ambulation and breathing exercises. The experimental group received an additional face-to-face 30-minute physiotherapy education and training session on pulmonary complications, early ambulation, and breathing exercises.OUTCOME MEASURES:Primary outcome was proportion of participants who remembered the taught breathing exercises following surgery. Secondary outcomes were recall of information sub-items and attainment of early ambulation goals. These were measured using standardised scoring of a semi-scripted digitally-recorded interview on the 5th postoperative day, and the attainment of early ambulation goals over the first two postoperative days.RESULTS:Experimental group participants were six-times more likely to remember the breathing exercises (95%CI 1.7 to 22) and 11-times more likely (95%CI 1.6 to 70) to report physiotherapy as the most memorable part of pre-admission clinic. Participants reported physiotherapy education content to be detailed, interesting, and of high value. Some participants reported not reading the booklet and professed a preference for face-to-face information delivery.CONCLUSION:Face-to-face pre-operative physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity.TRIAL REGISTRATION:ACTRN-12613000664741.

Background: Reduction in postoperative pain, nausea, and vomiting in patients undergoing total joint arthroplasty may facilitate earlier discharge from hospital and reduce healthcare costs. This study was performed to primarily assess whether perioperative dexamethasone reduced hospital length of stay and to assess the effect on pain, nausea and vomiting, and patient satisfaction. Methods: One hundred sixty-four patients undergoing total hip arthroplasty or total knee arthroplasty were randomized to receive either 8 mg intravenous dexamethasone (n = 86) or placebo (n = 78) at induction and at 24 hours postsurgery. The primary outcome was length of stay and secondary outcomes were pain and nausea visual analog scale scores, analgesic and antiemetic usage, blood glucose level, and patient satisfaction. Results: Participants in the study group achieved earlier readiness for discharge. There was a 20% reduction in pain scores and morphine usage was 27% lower in the study group. Nausea scores were similar in the 2 groups but there was lower antiemetic usage in the study group. Satisfaction scores at 6 weeks postsurgery in the dexamethasone group were significantly higher than the placebo group. There was no difference in complication rates between the 2 groups. Conclusion: The administration of intravenous dexamethasone could lead to earlier readiness for discharge especially in patients undergoing elective total hip arthroplasty, primarily by a reduction in postoperative pain scores and/or morphine requirements. (C) 2018 Elsevier Inc. All rights reserved.

OBJECTIVE:To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. DESIGN:Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. SETTING:Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. PARTICIPANTS:441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. INTERVENTIONS:Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. MAIN OUTCOME MEASURES:The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. RESULTS:The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected. CONCLUSION:In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard care alone.

Background Gestational diabetes mellitus (GDM) is associated with life‐long increased risk of type 2 diabetes: affected women are advised to undergo oral glucose tolerance testing (OGTT) at 6–12 weeks postpartum, then glucose screening every 1–3 years. Aims We investigated whether in women with GDM, antenatal clinical factors predicted postpartum abnormal glucose tolerance and compliance with screening. Materials and methods In women with GDM delivering 2007 to mid‐2009 in a single hospital, antenatal/obstetric data and glucose tests at 6–12 weeks postpartum and during 5.5 years post‐pregnancy were retrospectively collected. Predictors of return for testing and abnormal glucose tolerance were identified using multivariate analysis. Results Of 165 women, 117 (70.9%) returned for 6–12 week postpartum OGTT: 23 (19.6%) were abnormal. Smoking and parity, independent of socioeconomic status, were associated with non‐return for testing. Fasting glucose ≥5.4 mmol/L on pregnancy OGTT predicted both non‐return for testing and abnormal OGTT. During 5.5 years post‐pregnancy, 148 (89.7%) women accessed glucose screening: nine (6.1%) developed diabetes, 33 (22.3%) had impaired fasting glucose / impaired glucose tolerance. Predictors of abnormal glucose tolerance were fasting glucose ≥5.4 mmol/L and 2‐h glucose ≥9.3 mmol/L on pregnancy OGTT (~2.5‐fold increased risk), and polycystic ovary syndrome (~3.4 fold increased risk). Risk score calculation, based on combined antenatal factors, did not improve predictions. Conclusions Antenatal clinical factors were modestly predictive of return for testing and abnormal glucose tolerance post‐pregnancy in women with GDM. Risk score calculations were ineffective in predicting outcomes: risk scores developed in other populations require validation. Ongoing glucose screening is indicated for all women with GDM.

Objective: To assess graduates' self-reported preparedness with reference to a range of clinical practice capabilities, including those related to patient-centred care.Design: A retrospective survey of self-reported preparedness for practice, based on a survey developed by the Peninsula Medical School (United Kingdom) and adapted to account for Australian circumstances and to provide more information about patient-centred care-related capabilities.Setting and participants: Launceston Clinical School, a regional clinical school for undergraduate medical students. Medical students who had graduated during 2005-2014 and were contactable by email were invited to participate in the study.Main outcome measures: Graduates' self-reported preparedness for practice in 44 practice areas, measured on a 5-point Likert scale.Results: Responses from 135 graduates (50% of invited graduates, 38% of the eligible graduate population) were received. Most graduates felt prepared in 41 of the 44 practice areas; 80% felt at least well prepared in 17 areas. After clustering the 44 areas into six thematic groups, no differences were found between men and women who had graduated in the past 4 years. As male graduates become more experienced (5-10 years after graduation), retrospective perceptions of preparedness in some areas differed from those of more recent graduates; this was not found for female graduates.Conclusion: The survey identified strengths and weaknesses in the preparation of doctors for practice. It could be more broadly applied in Australia to obtain longitudinal data for assessing the quality of learning for curriculum planning purposes, and for aligning graduates' needs and expectations with those of the medical training and health care employment sectors.

Background Despite increasing efforts in perioperative management, postoperative iron deficiency anaemia persists, and few data are available about the management of this condition. In this study, we aimed to determine whether giving postoperative intravenous iron (in the form of ferric carboxymaltose) improved iron stores, haemoglobin concentrations, and outcomes following surgery.Methods We did a prospective, open-label, randomised, controlled study of patients at two centres (a general hospital and a private health-care centre) in Tasmania, Australia, undergoing elective surgery with functional iron deficiency anaemia (haemoglobin 70-120 g/L and ferritin <= 100 mu g/L or iron saturation <= 20%), measured at day 1 postoperatively. Consecutive routine elective surgical patients who were having major orthopaedic surgery, abdominal, and genitourinary surgery, and other surgeries were recruited. Via computer-generated randomisation, patients were randomly assigned (1:1) to either a single dose of intravenous 1000 mg ferric carboxymaltose (intervention group) or standard care, consisting of observation (control group). The primary endpoints were changes in haemoglobin concentrations and iron stores at 4 weeks postoperatively, and the number of transfused units of blood required postoperatively until discharge. Analyses were done on an intention-to-treat basis. This trial is registered with the Australian New Zealand Clinical Trials Registry and the WHO International Clinical Trials Registry platform (number ACTRN12614001261606).Findings Between Dec 17, 2014, and May 7, 2015, we recruited 201 eligible patients, assigning 103 to intravenous ferric carboxymaltose and 98 to standard care only. Baseline mean haemoglobin was 105.5 g/L (SD 13.8) in the standard care group versus 106.2 g/L (11.9) in the ferric carboxymaltose group, improving at 4 weeks to 121.5 g/L (SD 14.5) in the standard group and 130.1 g/L (11.3) in the ferric carboxymaltose group (mean difference of 7.84 g/L, 95% CI 3.79-11.9; p<0.0001 in favour of the ferric carboxymaltose group). Significant improvements in serum iron (5.36 mu mol/L, 95% CI 3.62-7.09; p<0.0001), iron saturation (11.40%, 95% CI 8.33-14.50; p<0.0001), and serum ferritin concentrations (468 mu g/L, 95% CI 355-582; p<0.0001) were also noted in the ferric carboxymaltose group at 4 weeks compared with standard care, although no differences were noted in transferrin concentrations (0.06 g/L, 95% CI -0.97 to 1.09; p=0.62). Fewer transfused blood units were given in the ferric carboxymaltose group (to one of 103 patients [<1%]) than in the standard care group (to five of 98 patients [5%]; incidence rate ratio 0.10; 95% CI 0.01-0.85; p=0.035). No adverse events were observed with ferric carboxymaltose treatment.Interpretation Postoperative intravenous ferric carboxymaltose is a feasible and pragmatic management approach in surgical patients with functional iron deficiency anaemia. Our study suggests that patient blood management guidelines should be updated, incorporating the use of postoperative intravenous iron infusion to optimise patient outcomes. Further trials to assess our approach are warranted.

AIM:Statins have pleiotropic effects that include attenuation of oxidative stress that may be relevant for chronic kidney disease (CKD) patients. We investigated the effect of long-term atorvastatin therapy on oxidative stress biomarkers in CKD patients. METHODS:This was a pre-specified secondary analysis of data from a randomized, double-blind, placebo-controlled trial (Lipid lowering and Onset of Renal Disease, LORD) in CKD patients. Participants received 10 mg/day atorvastatin (n = 47) or placebo (n = 39) for 3 years. Plasma measures (total F2-isoprostanes, malondialdehyde. protein carbonyls, uric acid, glutathione peroxidase (GPx) activity and total antioxidant capacity (TAC) ) were performed at baseline and at 3 years. Age and sex matched participants (n = 34) with normal kidney function were controls. RESULTS:CKD patients had significantly (P < 0.05) increased F2-isoprostanes and uric acid and decreased GPx activity compared with controls. When comparing the treatment (atorvastatin (A) vs placebo (P) ) change from baseline to 3 years, there were no significant differences (P > 0.05) in the group difference of the change values: (mean (95% CI), F2-isoprostanes = 5.3 (-29.2 to 39.8) pg/mL, protein carbonyls = 0.03 (-0.13 to 0.19) nmol/mg, GPx activity = -0.10 (-4.73 to 4.52) (U/L), uric acid = 8.8 (-33.9 to 51.6) μmol/L or TAC = -0.03 (-0.10 to 0.04) mmol/L. A significant difference (P = 0.04) in the change in malondialdehyde between groups, 1.52(0.09 to 2.96) μmol/L, was due to a large decrease in the placebo group. CONCLUSION:CKD patients had elevated oxidative stress that was not attenuated by atorvastatin 10 mg/day for 3 years.

BACKGROUND:Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery.METHODS/DESIGN:The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity.DISCUSSION:The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and physiotherapy, measures many known confounders, and includes a post-discharge follow-up of complication rates, functional capacity, and health-related quality of life. This trial is currently recruiting.TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.