A multicentre prospective double blinded randomised controlled trial of intravenous iron (ferric Derisomaltose (FDI)) in Iron deficient but not anaemic patients with chronic kidney disease on functional status.

BACKGROUND: Iron deficiency (ID) is common in patients with chronic kidney disease (CKD). Intravenous (IV) iron in heart failure leads to improvement in exercise capacity and improvement in quality-of-life measurements; however, data in patients with CKD are lacking. METHODS: The Iron and the Heart Study was a prospective double blinded randomised study in non-anaemic CKD stages 3b-5 patients with ID which investigated whether 1000 mg of IV iron (ferric derisomaltose (FDI)) could improve exercise capacity in comparison to placebo measured at 1 and 3 months post infusion. Secondary objectives included effects on haematinic profiles and haemoglobin, safety analysis and quality of life questionnaires (QoL). RESULTS: We randomly assigned 54 patients mean (SD) age for FDI (n = 26) 61.6 (10.1) years vs placebo (n = 28; 57.8 (12.9) years) and mean eGFR (33.2 (9.3) vs. 29.1 (9.6) ml/min/1.73m2) at baseline, respectively. Adjusting for baseline measurements, six-minute walk test (6MWT) showed no statistically significant difference between arms at 1 month (p = 0.736), or 3 months (p = 0.741). There were non-significant increases in 6MWT from baseline to 1 and 3 months in the FDI arm. Haemoglobin (Hb) at 1 and 3 months remained stable. There were statistically significant increases in ferritin (SF) and transferrin saturation (TSAT) at 1 and 3 months (p < 0.001). There was a modest numerical improvement in QoL parameters. There were no adverse events attributable to IV iron. CONCLUSION: This study demonstrated a short-term beneficial effect of FDI on exercise capacity, but it was not significant despite improvements in parameters of iron status, maintenance of Hb concentration, and numerical increases in functional capacity and quality of life scores. A larger study will be required to confirm if intravenous iron is beneficial in iron deficient non-anaemic non-dialysis CKD patients without heart failure to improve the 6MWT. TRIAL REGISTRATION: European Clinical Trials Database (EudraCT) No: 2014-004133-16 REC no: 14/YH/1209 Date First Registered: 2015-02-17 and date of end of trail 2015-05-23 Sponsor ref R1766 and Protocol No: IHI 141.

The effectiveness and safety of two prophylactic antibiotic regimes in hip-fracture surgery.

Antibiotic prophylaxis with cefuroxime can reduce the incidence of deep wound infection (DWI) in hip-fracture surgery, but may increase the risk of C. difficile infection (CDI). An alternative is gentamicin with beta-lactam for which a question exists around clinical effectiveness and safety, given the gentamicin-associated nephrotoxicity particularly in the elderly and narrower sensitivity spectrum. We compared 744 consecutive patients (group I-cefuroxime) with 756 in group II (gentamicin + flucloxacillin) who were well matched. There were 4 cases of CDI in the cefuroxime prophylaxis, whereas none in flucloxacillin plus gentamicin (group II). There was a statistically significant (p = 0.036) increased DWI rate in group II (2.5 %) as compared to group I (1.1 %). However, after controlling for age, gender, ASA grade, surgeon grade, implant type and type of anaesthesia, there was no statistically significant difference between the two groups (p = 0.146). 8.5 % of group I and 16.5 % of group II developed AKI post-operatively (p = 0.023); however, 79 % of group I and 80 % of in group II had complete resolution of AKI prior to their discharge. Further, a significant increase in inpatient deaths (p = 0.057) in group II was observed, but not at 30 days (p = 0.378).

Are intra-articular injections of Hylan G-F 20 efficacious in painful osteoarthritis of the knee? A systematic review & meta-analysis.

AIM: To systematically review evidence and perform a meta-analysis of the efficacy of intra-articular (IA) injections of Hylan G-F 20 for the treatment of painful osteoarthritis (OA) of the knee. METHODS: Systematic review of the Embase and PubMed databases up to July 2013 of randomised placebo-controlled trials studying the effect of Hylan G-F 20 in patients with painful knee OA, with a meta-analysis of trials reporting visual analogue scores (VAS) for weight-bearing pain in the knees of patients followed up for a minimum of 6 months. RESULTS: Six placebo-controlled randomised trials were identified on systematic review of which two studies met criteria for inclusion in the meta-analysis. Meta-analysis demonstrated that at 6-month follow up, there was no significant difference between Hylan G-F 20 and control in terms of reduction in VAS for weight bearing pain. (Mean Difference - 12.96 (95% CI: -35.48, 9.56). Z tests used to test for overall effect showed that the difference between the two groups was not significant (p = 0.26). DISCUSSION: A significant placebo effect exists for patients receiving IA injections for the treatment of painful knee OA. The withdrawal of fluid from the affected knee prior to any injectable therapy may itself have additional benefits which in isolation have not been studied. This may form the basis of future research. The authors' acknowledge that although limited conclusions can be drawn from the results of this study, the meta-analysis presented has not been performed previously and will further contribute to the knowledge on this subject. CONCLUSION: Although Hylan G-F 20 may produce improvement in VAS scores for weight-bearing pain at 6-month follow up in OA knees treated with it, patients should be informed that this may be equivalent to that seen with control treatments.

Modern cemented Furlong hemiarthroplasty: Are dislocations rates better?

BACKGROUND: Dislocation following hip hemiarthroplasty is a major complication with increased mortality and morbidity. Data looking at dislocation following contemporary bipolar stems are lacking in literature. METHODS: Retrospective review of our prospective national hip fracture database over a two-year period. Group 1 comprised of consecutive patients receiving bipolar Furlong prosthesis (N222) while Group 2 was made up of a historical cohort (uncemented; N254). Clinical and radiological records were reviewed to determine dislocation rates, causes and associative factors of dislocations. Data were analysed using SPSS. RESULTS: Following 476 hemiarthroplasties performed during the study period, 12 (2.5%) dislocations were reported (eight in Group 1; four in Group 2). There was no significant difference in dislocation rates (3.6% vs 1.6%) between groups (p = 0.159). Subgroup analysis of Group 1 demonstrated a significant difference in dislocations with Furlong cemented (6%) as compared with Furlong uncemented (0%) hemiarthroplasties (p = 0.024). Following dislocation, death rates increased to 8.3% from 1.7% in both groups. CONCLUSION: There is a statistically significant increase in dislocation rate following use of cemented Furlong prosthesis when compared to similar uncemented prosthesis at the same treatment period. However, when compared to traditional uncemented prosthesis, there is no difference in dislocation rates.

Rapid switching from levetiracetam to brivaracetam in pharmaco-resistant epilepsy in people with and without intellectual disabilities: a naturalistic case control study.

BACKGROUND: Approximately one quarter of people with an intellectual disability (PwID) have epilepsy of whom nearly three-quarters are pharmaco-resistant. There are higher reported neuropsychiatric side-effects to anti-seizure medication (ASM) in this group. Levetiracetam (LEV) is a first-line ASM with a stronger association with neuropsychiatric symptoms for PwID than other ASMs. Brivaracetam (BRV) is a newer ASM. Recent studies suggest a beneficial effect of swapping people who experience neuropsychiatric events with LEV to BRV. However, there is limited evidence of this for PwID. This evaluation analyses real world outcomes of LEV to BRV swap for PwID compared to those without ID. METHODS: We performed a multicentre, retrospective review of clinical records. Demographic, clinical characteristics and reported adverse events of patients switched from LEV to BRV (2016-2020) were recorded at 3 months pre and 6- and 12-month post-BRV initiation. Outcomes were compared between PwID and those without and summarised using cross-tabulations and logistic regression models. A Bonferroni correction was applied. RESULTS: Of 77 participants, 46 had ID and 52% had a past psychiatric illness. 71% participants switched overnight from LEV to BRV. Seizure reduction of > 50% was seen in 40% patients. Psychiatric illness history was predictive of having neuropsychiatric side-effects with LEV but not BRV (p = 0.001). There was no significant difference for any primary outcomes between PwID versus without ID. CONCLUSIONS: Switching from LEV to BRV appears as well tolerated and efficacious in PwID as those without ID with over 90% still on BRV after 12 months.

Effectiveness of out-patient based acute heart failure care: a pilot randomised controlled trial.

OBJECTIVES: Acute heart failure (AHF) hospitalisation is associated with 10% mortality. Outpatient based management (OPM) of AHF appeared effective in observational studies. We conducted a pilot randomised controlled trial (RCT) comparing OPM with standard inpatient care (IPM). METHODS: We randomised patients with AHF, considered to need IV diuretic treatment for ≥2 days, to IPM or OPM. We recorded all-cause mortality, and the number of days alive and out-of-hospital (DAOH). Quality of life, mental well-being and Hope scores were assessed. Mean NHS cost savings and 95% central range (CR) were calculated from bootstrap analysis. Follow-up: 60 days. RESULTS: Eleven patients were randomised to IPM and 13 to OPM. There was no statistically significant difference in all-cause mortality during the index episode (1/11 vs 0/13) and up to 60 days follow-up (2/11 vs 2/13) [p = .86]. The OPM group accrued more DAOH {47 [36,51] vs 59 [41,60], p = .13}. Two patients randomised to IPM (vs 6 OPM) were readmitted [p = .31]. Hope scores increased more with OPM within 30 days but dropped to lower levels than IPM by 60 days. More out-patients had increased total well-being scores by 60 days (p = .04). OPM was associated with mean cost savings of £2658 (95% CR 460-4857) per patient. CONCLUSIONS: Patients with acute HF randomised to OPM accrued more days alive out of hospital (albeit not statistically significantly in this small pilot study). OPM is favoured by patients and carers and is associated with improved mental well-being and cost savings.

Increasing incidence of invasive pneumococcal disease and pneumonia despite improved vaccination uptake: surveillance in Hull and East Yorkshire, UK, 2002-2009.

Introduction of pneumococcal polysaccharide (PPV23) and conjugate vaccine (PCV7) programmes were expected to change the epidemiology of invasive pneumococcal disease (IPD) and pneumonia in the UK. We describe the epidemiology of IPD and hospitalization with pneumonia using high-quality surveillance data over an 8-year period, 2002-2009. Although PPV23 uptake increased from 49% to 70% and PCV7 uptake reached 98% by 2009, the overall incidence of IPD increased from 11.8/100 000 to 16.4/100 000 (P=0.13), and the incidence of hospitalization with pneumonia increased from 143/100 000 to 207/100 000 (P<0.001). Although a reduction in the proportion of IPD caused by PCV7 serotypes was observed, concurrent increases in PPV23 and non-vaccine serotype IPD contributed to an increased IPD burden overall. Marked inequalities in the geographical distribution of disease were observed. Existing vaccination programmes have, so far, not been sufficient to address an increasing burden of pneumococcal disease in our locality.

An analysis of the performance of UK medical graduates in the MRCOG Part 1 and Part 2 written examinations.

BACKGROUND: There is a lack of evidence on whether graduates from different medical schools perform differently in postgraduate examinations. OBJECTIVE: To evaluate the variations in performance of UK medical graduates in Member of the Royal College of Obstetricians and Gynaecologists (MRCOG) examination. METHODS: A retrospective analysis of performance of 1335 doctors graduating in UK medical schools who entered the Part 1 MRCOG and 822 doctors taking the Part 2 MRCOG written examination for the first time between 1998 and 2008. The main outcome measures were to evaluate medical school effects, gender effects and academic performance effect. RESULTS: Graduates of UK medical schools performed differently in the Part 1 and Part 2 written MRCOG examination. The graduates of Oxford (pass rate 82.6%), Cambridge (75%), Bristol (59.3%) and Edinburgh (57.5%) performed significantly better and the graduates of Liverpool (26.8%), Southampton (21.8%) and Wales (18.2%) performed significantly worse than the remaining cohort in the Part 1 examination. The candidates of Newcastle (88.9%), Oxford (82.4%), Cambridge (81%) and Edinburgh (78.2%) performed significantly better and the graduates of Glasgow (49.2%) and Leicester (36.2%) have significantly underperformed compared with the remaining cohort in Part 2 written examination. There was no difference in the success rates of male (47.5%) and female (42.0%) candidates in the Part 1; however, female candidates had a significantly better success rate in the Part 2 written examination than male candidates (65.6% vs 52.9%). CONCLUSION: These results show that there is variation in performance among the graduates from different medical schools in the Part 1 and Part 2 MRCOG written examination.

Modelling the effect of venous disease on quality of life.

BACKGROUND: A clear understanding of the relationship between venous reflux, clinical venous disease and the effects on quality of life (QoL) remains elusive. This study aimed to explore the impact of venous disease, and assess any incremental direct effect of progressive disease on health-related QoL, with the ultimate aim to model venous morbidity. METHODS: Consecutive patients with venous disease were assessed for inclusion in the study. Patients with isolated, unilateral, single superficial axial incompetence diagnosed on duplex imaging were included. Clinical grading was performed with the Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification and Venous Clinical Severity Score (VCSS). Patients completed generic (Short Form 36, SF-36(®); EuroQol 5D, EQ-5D(™)) and disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ) QoL instruments. Multivariable regression modelling was performed, taking account of demographic and anatomical factors, to explore the effect of clinical severity on QoL impairment. RESULTS: Some 456 patients with C2-6 venous disease were included, along with control data for 105 people with C0-1 disease. Increasing clinical grade corresponded strongly with deterioration in disease-specific QoL (P < 0.001). This could be stratified into three distinguishable groups: C0-1, C2-4 and C5-6 (P < 0.001 to P = 0.006). Increasing clinical grade also corresponded with deterioration in the physical domains of SF-36(®) (P < 0.001 to P = 0.016), along with EQ-5D(™) index utility (quality-adjusted life year) scores (P < 0.001). CONCLUSION: Demonstrable morbidity was seen, even with uncomplicated venous disease. The physical impairment seen with venous ulceration was comparable with that seen in congestive cardiac failure and chronic lung disease.

Evaluation of the MP Rapid 2019-NCOV IgM/IgG combo POCT test vs. an established platform-based method.

BACKGROUND: Accurate and rapid testing for SARS-COV-2 antibodies could improve the diagnosis and management of COVID-19. In this study, we aim to evaluate the diagnostic accuracy of a commercially available point-of-care lateral flow kit independently and in comparison to an established platform-based system. METHOD: Samples from 144 PCR-confirmed COVID-19 cases and 130 pre-pandemic negative controls were tested in parallel by MP Rapid 2019-NCOV IgM/IgG Combo test and Roche Elecsys. Comparison of results based on serum and capillary blood testing was undertaken. RESULTS: Sensitivity at day 15 onwards was 100% for both methods. Between days 1 and 7 post admission, the IgM/IgG Combo test and Roche Elecsys shown sensitivity of 74% (95%CI: 62%-85%) vs. 67% (95% CI: 55%-79%, P = 0.3947). Combo test specificities were 100% for IgG, 98.5% for IgM vs. Roche Elecsys specificity of 100%. Concordance analysis showed 98.5% agreement to the Roche Elecsys method (Cohen's Kappa 0.96 95% CI [0.92-0.99]). Capillary blood results showed complete agreement with serum samples using the Combo test. CONCLUSION: In comparison to Roche Elecsys, our data show that the MP Rapid 2019-NCOV IgM/IgG Combo test provides a high-confidence assay system for the detection of previous exposure to SARS-COV-2 infection with advantage of affording near-patient testing.

Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity.

AIM: The durability of occlusion post endovenous laser therapy (EVLT) for varicose veins is linked to the magnitude of energy delivered to the vein and consequently increasing amounts of energy are employed. The aim of this study is to establish whether increasing the energy results in greater periprocedural morbidity or complications. METHODS: Linear and logistic regression models were built to study the effect of energy delivery on outcome. The models controlled for age, gender, BMI, pre-operative quality of life and vein dimension. The outcomes were pain and analgesia requirement in week 1, change in disease specific quality of life (Aberdeen varicose vein questionnaire (AVVQ), change in generic quality of life (Short Form-36 (SF-36) and Euroqol (EQ5D)at week 1 and 6 and complication rates. The sample size calculation established that 115 patients would be required to detect any significant relationship. RESULTS: 232 patients were included. The mean (range) age was 50 (18-83) years. 63% were women. The mean (range) energy delivery was 89.8 (44.5-158.4) J/cm. There was no significant effect on any outcome related to increasing energy delivery. CONCLUSION: Up to 160 J/cm, increasing energy delivery has no significant effect upon the morbidity or complications of EVLT for superficial venous insufficiency.

Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets.

AIM: The aim of this study was to compare ezetimibe/simvastatin combination therapy with intensified statin monotherapy as alternative treatment strategies to achieve the Joint British Societies (JBS)-2 and National Institute for Health and Clinical Excellence low-density-lipoprotein cholesterol (LDL-C) target of < 2 mmol/l for secondary prevention or JBS-2 LDL-C target of < 2 mmol/l for primary prevention in high-risk patients who have failed to reach target with simvastatin 40 mg. METHODS: This is a prospective, double-blind study conducted in 34 UK primary care centres; 1748 patients with established cardiovascular disease (CVD), diabetes or high risk of CVD who had been taking simvastatin 40 mg for > or = 6 weeks were screened and 786 (45%) with fasting LDL-C > or = 2.0 mmol/l (and < 4.2 mmol/l) at screening and after a further 6-week run-in period on simvastatin 40 mg were randomised to ezetimibe/simvastatin 10/40 mg (as a combination tablet; n = 261), atorvastatin 40 mg (n = 263) or rosuvastatin 5 mg (n = 73) or 10 mg (n = 189) once daily for 6 weeks. Rosuvastatin dose was based on UK prescribing instructions. The primary outcome measure was the proportion of patients achieving LDL-C < 2 mmol/l at the end of the study. RESULTS: The percentage of patients (adjusted for baseline differences) achieving LDL-C < 2 mmol/l was 69.4% with ezetimibe/simvastatin 10/40 mg, compared with 33.5% for atorvastatin 40 mg [odds ratio 4.5 (95% CI: 3.0-6.8); p < 0.001] and 14.3% for rosuvastatin 5 or 10 mg [odds ratio 13.6 (95% CI: 8.6-21.6); p < 0.001]. Similar results were observed for achievement of total cholesterol < 4.0 mmol/l. All study treatments were well tolerated. CONCLUSION: Approximately 45% of patients screened had not achieved LDL-C < 2 mmol/l after > or = 12 weeks of treatment with simvastatin 40 mg. In this group, treatment with ezetimibe/simvastatin 10/40 mg achieved target LDL-C levels in a significantly higher proportion of patients during a 6-week period than switching to either atorvastatin 40 mg or rosuvastatin 5-10 mg.

Prospective study comparing the outcome of a population-specific adjusted calcium equation to ionized calcium.

BACKGROUND: Calcium circulates bound to albumin and changes in albumin concentration will therefore affect total calcium measurements. In order to mitigate this, correction factors are frequently used. The most widely used correction equation was described by Payne and colleagues in 1973. This equation was derived from well-defined hospitalized patients' data. Current clinical practice is consistent with the general application of the adjusted calcium equation irrespective of clinical setting. This study aims to assess the validity of this approach by the derivation of a community care-specific adjusted calcium equation ('community equation') and the comparison of its performance to a hospitalized patient equation and ionized calcium. METHOD: Retrospective data were collected according to Payne's criteria from an inpatient and community care setting. Data were used to derive the two equations: the in-patient equation and community equation. The outcome of these equations was compared with ionized calcium obtained from 123 healthy participants. RESULTS: The community equation correctly identified the calcium status of 92% of the 123 healthy participants, while the inpatient equation identified 46% only. Regression analysis against ionized calcium showed a higher R2 for the community equation than for the inpatient equation. Furthermore, we have shown that mean albumin and calcium concentrations are significantly different between these two populations. CONCLUSION: In this study, we found that the diagnostic accuracy of the adjusted calcium equation in ambulant patients was improved by the derivation of a population-specific equation for the community care setting.

A double-blinded randomised controlled study to investigate the effect of intraperitoneal levobupivacaine on post laparoscopic pain.

BACKGROUND: Laparoscopic surgery is the cornerstone of modern gynaecological surgery, with shorter hospital stays and a quicker return to normal activities. However postoperative pain remains problematic. No strategy to reduce phrenic nerve irritation, including heating or humidifying the insufflating gas, alternatives to CO2, and intraperitoneal analgesics, has shown superiority. METHODS: 100 women undergoing laparoscopic surgery were randomly allocated, having either 40ml of 0.25% levobupivacaine or 40ml 0.9% sodium chloride solution administered into the peritoneal cavity following surgery. The patients and the main researcher were blinded. All women received standardised anaesthetic and laparoscopic technique, and postoperative pain control including nursing position and nature of analgesia. Postoperative pain was assessed 3 hours, 8 hours, day 1 and day 4/5 postoperatively. RESULTS: 100 patients were recruited undergoing surgery for benign causes aged 19-73(mean 40.3±13). There was no difference between the groups for age(p=0.64) or length of operation(p=0.56). There were no adverse events related to use of intraperitoneal instillation. There was a significant reduction in shoulder-tip pain scores in the levobupivacaine group at 3 hours(p=0.04). Furthermore, there was a significant reduction in wound-pain scores in the levobupivacaine group at 8hrs(p=0.04) and at day 4(p=0.04). No difference was found in pelvic pain between the two groups. No significant difference was found in the use of post-operative analgesia. CONCLUSIONS: Intraperitoneal instillation of 40ml of levobupivacaine has some benefit in reducing postoperative pain and need for analgesia in the initial hours following gynaecological surgery. However, further well-designed randomised control trials are required to decide the optimum route and concentration of administering local anaesthetic.

Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): study protocol for a randomised controlled trial analysing clinical and cost-effectiveness of Social Stories™ in primary schools.

BACKGROUND: Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC) can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs). Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely. METHODS: A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This study will recruit 278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England. Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants' social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have been obtained from the University of York's Research Governance Committee, Research Ethics Committee and the Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and disseminated to participating families, educational staff, local authority representatives, community groups and Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence dependent on findings. DISCUSSION: This study addresses a much used but currently under researched intervention and results will inform school based support for primary school children with a diagnosis of ASC. TRIAL REGISTRATION: The trial is registered on the ISRCTN registry (registration number: ISRCTN11634810). The trial was retrospectively registered on 23rd April 2019.

Are there more bowel symptoms in children with autism compared to normal children and children with other developmental and neurological disorders?: A case control study.

There is considerable controversy as to whether there is an association between bowel disorders and autism. Using a bowel symptom questionnaire we compared 51 children with autism spectrum disorder with control groups of 35 children from special school and 112 from mainstream school. There was a significant difference in the reporting of certain bowel symptoms (constipation, diarrhoea, flatulence) and food faddiness between the autism group and the mainstream school control group. There was no significant difference between the autism group and children in the special schools except for faddiness, which is an autism specific symptom and not a bowel symptom. This study confirms previously reported findings of an increase in bowel symptoms in children with autism. It would appear, however, that this is not specifically associated with autism as bowel symptoms were reported in similar frequency to a comparison group of children with other developmental and neurological disorders.

A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

BACKGROUND: Hip fracture is a procedure with high mortality and complication rates, and there exists a group especially at risk of these outcomes identified by their Nottingham Hip Fracture Score (NHFS). Meta-analysis suggests a possible benefit to this patient group from intravascular volume optimisation. We investigated whether intraoperative fluid and blood pressure optimisation improved complications in this group. METHODS: Patients with a NHFS ≥ 5 were enrolled into this multicentre observer-blinded randomised control trial. Patients were allocated to either standard care or a combination of fluid optimisation and blood pressure control using a non-invasive system. The primary outcome was the number of patients with one or more complications in each group. Secondary outcomes included hospital length of stay (LOS), incidence of hypotension and fluid and vasopressor usage. RESULTS: Forty-six percent of patients in the intervention group suffered one or more complications compared to the 51% in the control group (OR 0.82 (95% CI 0.49-1.36)). Per-protocol analysis improved the OR to 0.73 (95% CI 0.43-1.24). Median LOS was the same between both groups; however, the mean LOS on a per-protocol analysis was longer in the control group compared to the intervention group (23.2 (18.0) days vs. 18.5 (16.5), p = 0.047). CONCLUSIONS: Haemodynamic optimisation including blood pressure management in high-risk patients undergoing repair of a hip fracture did not result in a statistically significant reduction in complications; however, a potential reduction in length of stay was seen. TRIAL REGISTRATION: A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

Development and validation of a delayed presenting clubfoot score to predict the response to Ponseti casting for children aged 2-10.

The aim of the study was to develop a simple and reliable clinical scoring system for delayed presenting clubfeet and assess how this score predicts the response to Ponseti casting. We measured all elements of the Diméglio and the Pirani scoring systems. To determine which aspects were useful in assessing children with delayed presenting clubfeet, 4 assessors examined 42 feet (28 patients) between the ages of 2-10 years. Selected variables demonstrating good agreement were combined to make a novel score and were assessed prospectively on a separate consecutive cohort of children with clubfeet aged 2-10, comprising 100 clubfeet (64 patients). Inter-observer and intra-observer agreement was found to be greatest using the following clinically measured angles of the deformities. These were plantaris, adductus, varus, equinus of the ankle and rotation around the talar head in the frontal plane (PAVER). Measured angles of 1-20, 21-45 and > 45 degrees scored 1, 2 and 3 points, respectively. The PAVER score was derived from both the sum of points derived from measured angles and a multiplier according to age. The sum of the points was multiplied with 1, 1.5 or 2 for ages 2-4, 5-7 and 8-10, respectively. This demonstrated a good association with the total number of casts to achieve a full correction (tau = 0.71). A score greater than 18 out of 30 indicated a cast-resistant clubfoot. The score could be used clinically for prognosis and treatment, and for research purposes to compare the severity of clubfoot deformities.

The under use of thromboprophylaxis in older medical in-patients: a regional audit.

BACKGROUND: The risk of venous thromboembolism (VTE) among medical in-patients increases with age. Thromboprophylaxis using low-molecular-weight heparin can reduce the incidence by 50%, but anecdotally is under-used in medical patients, particularly the elderly. AIM: To examine prescribing practice for thromboprophylaxis in elderly in-patients in the Yorkshire region. DESIGN: Regional audit of medical records and drug charts. METHODS: A simultaneous audit was done of all medical in-patients >75 years on 30 wards in 10 hospitals. Guidelines published by the Scottish Intercollegiate Guidelines Network (SIGN) on the use of thromboprophylaxis were used as the standard. Data were collected on contraindications and/or indications for thromboprophylaxis and the type of prophylaxis used. RESULTS: Of 601 patients studied (mean age 84.6 years), 117 (19.5%) had indications for thromboprophylaxis with no contraindications. Of these 117, 34 (29%) were receiving prophylaxis as per guidelines. There was more than one indication for thromboprophylaxis in 17% of those left untreated. The mean age of those receiving therapy was similar to those not receiving it (84.0 vs. 84.5 years, p = 0.66, t-test). Elderly in-patients on medical wards were more likely to receive appropriate treatment than those on geriatric wards (43% vs. 23%, p = 0.03, chi(2) test). DISCUSSION: Thromboprophylaxis is under-used in older medical in-patients, despite their increased risk of VTE, particularly on geriatric wards. Greater consideration by doctors attending to older medical patients is needed if VTE is to be prevented.