Early surgery improves survival after femoral fractures in the elderly: A retrospective review of 502 fragility fractures.

AIMS: Fragility fractures are a growing global healthcare burden; fragility fractures of the femur have been shown to occur in a highly comorbid patient group, with parallels to hip fracture patients. This study aimed to investigate if early surgery for femoral fractures, distal to the hip, resulted in a reduction in mortality in patients over 65 years of age. METHODS: A retrospective review of prospectively collected data for all consecutive femoral fractures in patients aged over 65 years who underwent surgical management between January 2000 and December 2018. Data was extracted from the Fracture Outcomes Research Database (FORD) and analysed to assess if early surgery, defined as occurring within 48 h of hospital admission with a fragility femur fracture, had an effect on 30 day and 1 year mortality. RESULTS: 502 eligible patients were included; median follow up time was 57 months. 24 patients (4.7%) died within 30 days of surgery and 105 patients (20.9%) had died within 1 year of surgery. Patients who underwent surgery within 48 h of admission had a significantly reduced chance of mortality within 1 year of surgery compared to patients who had surgery more than 48 h after admission (OR = 0.401, 95% CI 0.25-0.65, p<0.001). Following Multivariate Cox Regression analysis the hazard ratio of 1 year mortality following early surgery remained significantly reduced (HR = 0.57, 95% CI 0.36-0.92, p = 0.020). CONCLUSIONS: This study demonstrates that fragility femoral fracture patients represent a similar cohort to hip fracture patients, with high mortality rates. We recommend that hip fracture management principles are also employed for fragility femoral fractures in patients over 65 years, with rapid pre-operative optimisation to ensure these patients undergo early surgical intervention.

Gender Diversity, Leadership, Promotion, and Opportunity Among the Members of the Orthopaedic Trauma Association (OTA).

OBJECTIVES: To demonstrate the gender distribution in leadership positions and academic promotion of Orthopaedic Trauma Association (OTA) members. METHODS: We conducted a cross-sectional examination of the 2020-2021 OTA membership cohort dataset provided by the OTA. Professional and academic information of OTA members at their site of appointment was also abstracted from publicly available online resources. Data included: gender, OTA membership category, OTA leadership position, trauma fellowship completion, trauma practice setting, level of trauma center, percentage of trauma work, year of first practice, academic rank, and university/hospital/institutional leadership role. Statistical analysis included chi-squared, Wilcoxon two-sample, and Fisher exact tests. RESULTS: 2608 OTA members were identified; 14.1% were women. Female representation was highest in the Trauma Practice Professional category (67.1%) and significantly lower in the Active category (9.1%) ( P < 0.0001). No statistically significant gender differences were observed regarding level of trauma center, percentage of trauma work, or trauma practice setting. In the Active, Clinical and Emeritus categories, men achieved a higher level of academic rank than women at their site of employment ( P = 0.003), while more men completed trauma fellowships ( P = 0.004) and had been in practice for significantly longer ( P < 0.0001). Men held more of the highest leadership positions (eg, Board of Directors) ( P = 0.0047) and the greatest number of leadership positions ( P = 0.017) within the OTA compared with women. CONCLUSION: Gender disparity exists within the upper echelon of leadership and academic representation in orthopaedic trauma. Our findings will help inform strategic policies to address gender diversity within the OTA and the broader orthopaedic trauma subspecialty.

Operative management of lateral third clavicle fractures: a comparison of internal fixation methods.

PURPOSE: Clavicle fractures in the lateral third are associated with more complications. Various methods of internal fixation exist; however, there is no consensus which should be employed. The purpose of this study was to evaluate the outcomes of these various methods in our regional trauma unit. METHODS: We performed a retrospective review of patients who underwent internal fixation of a lateral clavicle fracture in our unit between 1 August 2014 and 31 July 2019. Demographic and outcome data were extracted from electronic care records and imaging systems. RESULTS: In total, 44 patients were included, with the following demographics: mean age 26 years, 63.6% male, 65.9% high-energy injury, 68.2% Neer II fracture. The following operations were performed: hook plate fixation (HPF) = 10, locking plate fixation (LPF) = 16, coracoclavicular ligament reconstruction (CCLR) = 12, and LPF + CCLR = 6. Patients having LPF had a significantly larger post-operative coracoclavicular distance (7.6 mm vs 13.5 mm, p < 0.01), and trends towards a lesser decrease in CCD (9.9 mm vs 12.6 mm, p = 0.37) and incomplete ACJ reduction (50.0% vs 89.3%, p = 0.11). There was a significantly higher re-operation rate after HPF (100% vs 23.5%, p < 0.01). There were no differences in time to union or duration of follow-up. CONCLUSION: In our unit there is no clearly favoured method of internal fixation of lateral clavicle fractures. When LPF is used, there should be consideration of concomitant CCLR. The high rate of re-operation after HPF is concordant with previous research.

Stakeholder outcome prioritization in the Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA) trial.

BACKGROUND: The Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA) study is a randomized, pragmatic trial investigating different tumour necrosis factor inhibitor de-escalation strategies for children with sustained inactive disease. In this project, we elicited concept rankings that aided in the selection of the patient-reported outcome (PRO) measures that should be examined as part of the BACK-OFF JSpA trial. METHODS: We conducted a discrete choice experiment to evaluate individuals' preferences regarding PROs. Stakeholders assessed a discrete list of 21 outcome concepts, each of which had a Patient-Reported Outcome Measurement Information System (PROMIS) measure associated with it. PROMIS measures are self- or proxy-reported instruments that are universally applicable to the general population and all chronic conditions. Stakeholders were required to make choices instead of expressing the strength of a preference. RESULTS: Fourteen caregivers, 12 patients (9-22 years old), 16 rheumatologists and three executives from health insurance companies completed the exercise, which took approximately 10 min. The discrete choice experiment resulted in an estimate of the relative importance of each outcome and rank. All stakeholder groups agreed that the primary PRO should be 'Pain Interference', a measure that evaluates the effect of pain on a child's everyday activities, including its impact on social, emotional, mental and physical functioning. Patients and caregivers were mostly aligned in their top priorities, with patients valuing physical health (50% of the top 10) whereas caregivers were more interested in mental health (60% of the top 10). Rheumatologists and health insurance executives were most interested in physical health outcomes, which were ranked 80% and 60% of their top 10 PROs, respectively. Overall, the patients had the most diverse set of prioritized outcomes, including at least one of each category in their top 10 rank order of importance. Patients were also the only stakeholders to prioritize 'social' health. CONCLUSIONS: Patients and caregivers were mostly aligned in their outcome priority rankings. The rank-order list directly informed the creation of a profile of PRO measures for our upcoming trial. PATIENT OR PUBLIC CONTRIBUTION: Stakeholder partners helped with acquisition of data and lead parent partners helped interpret data.

Assessment of the utility of the National Health Service England Low Back and Radicular Pain Pathway: analysis of patient reported outcomes.

INTRODUCTION: Lumbar disc herniation causing radiculopathy is a common reason for referral to spinal out-patient clinics. At our centre following routine referral, patients wait a mean of 109 weeks for a consultation with a spinal surgeon. A pathway in keeping with the National Health Service England Low Back and Radicular Pain Pathway was introduced with two objectives. Patients would be seen sooner by suitably trained health care professionals to avoid long waiting times for assessment with a spinal surgeon, and if a set of criteria were met, they would receive a selective nerve root injection to manage their pain. METHODS: Patients were seen by specially trained orthopaedic physiotherapists following routine general practitioner (GP) referral. A radiologically guided nerve root injection was carried out if patients had radicular pain between 6 and 52 weeks duration and a magnetic resonance imaging (MRI) scan demonstrating an intervertebral disc prolapse correlating with their radicular symptoms. Patient-recorded outcome measures were taken before and after nerve root injection. RESULTS: Seventy five patients entered the pathway. Mean patient age was 49.9 years and 27 patients (36.0%) were male. Mean time from referral to assessment was 15.5 weeks. Mean visual analogue score (VAS) for leg pain was 7.4 out of 10 before nerve root injection and 4.8 out of 10 following nerve root injection (p < 0.001). Mean Oswestry Low Back Pain Disability Questionnaire score before nerve root injection was 58.4% and 49.7% following nerve root injection (p = 0.024). Mean Euroqol EQ-5D-5L Health Index was 0.2 before nerve root injection and 0.4 afterwards (p < 0.001). CONCLUSION: This study suggests that this pathway may help to reduce waiting times for patients with lumbar radiculopathy secondary to intervertebral disc prolapse. The resulting enhanced care may be associated with a reduction in leg and back pain and an improvement in quality of life.

Cost-effectiveness of a combined classroom curriculum and parental intervention: economic evaluation of data from the Steps Towards Alcohol Misuse Prevention Programme cluster randomised controlled trial.

OBJECTIVES: This study aimed to assess the cost-effectiveness of the Steps Towards Alcohol Misuse Prevention Programme (STAMPP) compared with education as normal (EAN) in reducing self-reported heavy episodic drinking (HED) in adolescents. DESIGN: This is a cost-effectiveness analysis from a public sector perspective conducted as part of a cluster randomised trial. SETTING: This study was conducted in 105 high schools in Northern Ireland and in Scotland. PARTICIPANTS: Students in school year 8/S1 (aged 11-12) at baseline were included in the study. INTERVENTIONS: This is a classroom-based alcohol education curricula, combined with a brief alcohol intervention for parents/carers. OUTCOME MEASURES: The outcome of this study is the cost per young person experiencing HED avoided due to STAMPP at 33 months from baseline. RESULTS: The total cost of STAMPP was £85 900, equivalent to £818 per school and £15 per pupil. Due to very low uptake of the parental component, we calculated costs of £692 per school and £13 per pupil without this element. Costs per pupil were reduced further to £426 per school and £8 per pupil when it was assumed there were no additional costs of classroom delivery if STAMPP was delivered as part of activities such as personal, social, health and economic education. STAMPP was associated with a significantly greater proportion of pupils experiencing a heavy drinking episode avoided (0.08/8%) and slightly lower public sector costs (mean difference -£17.19). At a notional willingness-to-pay threshold of £15 (reflecting the cost of STAMPP), the probability of STAMPP being cost-effective was 56%. This level of uncertainty reflected the substantial variability in the cost differences between groups. CONCLUSIONS: STAMPP was relatively low cost and reduced HED. STAMPP was not associated with any clear public sector cost savings, but neither did it increase them or lead to any cost-shifting within the public sector categories. Further research is required to establish if the cost-effectiveness of STAMPP is sustained in the long term. TRIAL REGISTRATION NUMBER: ISRCTN47028486; Results.

Recanting of Previous Reports of Alcohol Consumption within a Large-Scale Clustered Randomised Control Trial.

The aim of this study was to examine the extent of recanting (inconsistencies in reporting of lifetime alcohol use) and its impact on the assessment of primary outcomes within a large-scale alcohol prevention trial. One hundred and five post-primary schools in were randomised to receive either the intervention or education as normal. Participants (N = 12,738) were secondary school students in year 8/S1 (mean age 12.5) at baseline. Self-report questionnaires were administered at baseline (T0) and at T1 (+ 12 months post-baseline), T2 (+ 24 months) and T3 (+ 33 months). The primary outcomes were (i) heavy episodic drinking (consumption of ≥ 6 units in a single episode in the previous 30 days for males and ≥ 4.5 units for females) assessed at T3 and (ii) the number of alcohol-related harms experienced in the last 6 months assessed at T3. Recanting was defined as a negative report of lifetime alcohol consumption that contradicted a prior positive report. Between T1 and T3, 9.9% of students recanted earlier alcohol consumption. Recanting ranged from 4.5 to 5.3% across individual data sweeps. While recanting was significantly associated (negatively) with both primary outcomes, the difference in the rate of recanting across trial arms was small, and adjusting for recanting within the primary outcome models did not impact on the primary outcome effects. Males were observed to recant at a greater rate than females, with a borderline small-sized effect (V = .09). While differential rates of recanting have the potential to undermine the analysis of prevention trial outcomes, recanting is easy to identify and control for within trial primary outcome analyses. Adjusting for recanting should be considered as an additional sensitivity test within prevention trials.Trial Registration: ISRCTN47028486 ( http://www.isrctn.com/ISRCTN47028486 ). The date of trial registration was 23/09/2011, and school recruitment began 01/11/2011.

Assessment of the effect of addition of 24 hours of oral tranexamic acid post-operatively to a single intraoperative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty (TRAC-24): a study protocol for a randomised controlled trial.

BACKGROUND: While it is has been proven that tranexamic acid (TXA) reduces blood loss in primary total hip and knee arthroplasty (THA and TKA), there is little published evidence on the use of TXA beyond 3 h post-operatively. Most blood loss occurs after wound closure and the primary aim of this study is to determine if the use of oral TXA post-operatively for up to 24 h will reduce calculated blood loss at 48 h beyond an intra-operative intravenous bolus alone following primary THA and TKA. To date, most TXA studies have excluded patients with a history of thromboembolic disease. METHODS/DESIGN: This is a phase IV, single-centred, open-label, parallel-group, randomised controlled trial. Participants are randomised to one of three groups: group 1, an intravenous (IV) bolus of TXA peri-operatively plus oral TXA post-operatively for 24 h; group 2, an IV bolus of TXA peri-operatively or group 3, standard care (no TXA). Eligible participants, including those with a history of thromboembolic disease, are allocated to these groups with a 2:2:1 allocation ratio. The primary outcome is the indirectly calculated blood loss 48 h after surgery. Researchers and patients are not blinded to the treatment; however, staff processing blood samples are. Originally 1166 participants were required to complete this study, 583 THA and 583 TKA. However, following an interim analysis after 100 THA and 100 TKA participants had been recruited to the study, the data monitoring ethics committee recommended stopping group 3 (standard care). DISCUSSION: TRAC-24 will help to determine whether an extended TXA dosing regimen can further reduce blood loss following primary THA and TKA. By including patients with a history of thromboembolic disease, this study will add to our understanding of the safety profile of TXA in this clinical situation. TRIAL REGISTRATION: ISRCTN registry, ISRCTN58790500 . Registered on 3 June 2016, EudraCT: 2015-002661-36.

Steps Towards Alcohol Misuse Prevention Programme (STAMPP): a school-based and community-based cluster randomised controlled trial.

OBJECTIVES: To assess the effectiveness of a combined classroom curriculum and parental intervention (the Steps Towards Alcohol Misuse Prevention Programme (STAMPP)), compared with alcohol education as normal (EAN), in reducing self-reported heavy episodic drinking (HED) and alcohol-related harms (ARHs) in adolescents. SETTING: 105 high schools in Northern Ireland (NI) and in Scotland. PARTICIPANTS: Schools were stratified by free school meal provision. Schools in NI were also stratified by school type (male/female/coeducational). Eligible students were in school year 8/S1 (aged 11-12 years) at baseline (June 2012). INTERVENTION: A classroom-based alcohol education intervention, coupled with a brief alcohol intervention for parents/carers. PRIMARY OUTCOMES: (1) The prevalence of self-reported HED in the previous 30 days and (2) the number of self-reported ARHs in the previous 6 months. Outcomes were assessed using two-level random intercepts models (logistic regression for HED and negative binomial for number of ARHs). RESULTS: At 33 months, data were available for 5160 intervention and 5073 control students (HED outcome), and 5234 and 5146 students (ARH outcome), respectively. Of those who completed a questionnaire at either baseline or 12 months (n=12 738), 10 405 also completed the questionnaire at 33 months (81.7%). Fewer students in the intervention group reported HED compared with EAN (17%vs26%; OR=0.60, 95% CI 0.49 to 0.73), with no significant difference in the number of self-reported ARHs (incident rate ratio=0.92, 95% CI 0.78 to 1.05). Although the classroom component was largely delivered as intended, there was low uptake of the parental component. There were no reported adverse effects. CONCLUSIONS: Results suggest that STAMPP could be an effective programme to reduce HED prevalence. While there was no significant reduction in ARH, it is plausible that effects on harms would manifest later. TRIAL REGISTRATION NUMBER: ISRCTN47028486; Post-results.

Oral health behaviours of parents and young children in a practice-based caries prevention trial in Northern Ireland.

OBJECTIVES: The NICPIP trial evaluated the costs and effects of a caries prevention intervention delivered to 2- to 3-year-old children attending dental practices in Northern Ireland. This supplementary study explored the oral health behaviours of children and their parents to help understand the reasons for the trial's findings. METHODS: A mixed methods study that included a questionnaire completed by all parents (n = 1058) at the time they brought their child for the NICPIP final clinical assessment. The questionnaire collected data on frequency of toothbrushing and sugar consumption. Questionnaire data were analysed by trial group and caries status. Parents of trial participants (n = 42) were invited to take part in telephone interviews. Parents were purposively sampled according to trial group and whether or not their child developed caries. The interviews explored how and why oral health behaviours happened. Interview data were audio-recorded, transcribed verbatim and analysed thematically. RESULTS: The questionnaire data indicated that toothbrushing and between-meal sugar snacking were common in the majority of children. The children of parents who automatically reminded their child to brush their teeth were more likely to remain caries-free (Odds Ratio 1.24; 95% CI 1.08, 1.41; P = .002). Frequency of sweet drink consumption was associated with the child developing caries (Odds Ratio 0.88; 95% CI 0.79, 0.98; P = .021). The interview data showed that parents had positive attitudes towards brushing both in terms of perceived importance and expected outcomes. Attitudes towards sugar snacking were more complex, with parents reporting difficulties in controlling this behaviour. Sugar was described as being something that was "ever present" in children's lives. CONCLUSIONS: Toothbrushing was widely adopted from a young age, but between-meal sugar consumption was highly prevalent. The results suggest that effective family-level and population-level interventions are needed to reduce sugar consumption if substantial improvements in caries prevention are to be achieved.

Percutaneous Arthroscopic-assisted Glenoid Fixation: A Novel Surgical Technique.

INTRODUCTION: Scapular fractures are rare injuries and are often an indicator of high-energy trauma. These injuries are rare, and many are managed without surgery. The caveat to this is intra-articular extension into the glenoid when AO Foundation principles of fracture fixation for intra-articular injuries must be adhered to. We report a percutaneous arthroscopically assisted technique for fixation of a scapular fracture with extension into the glenoid fossa in a young male patient. CASE REPORT: A 22-year-old Caucasian male presented to the emergency department after a road traffic collision. Primary assessment and secondary surgery demonstrated an isolated shoulder injury involving the glenoid. Three-dimensional imaging was performed and revealed an intra-articular glenoid fracture with the involvement of the superior suspensory apparatus of the shoulder, not fitting into known classification systems. He underwent an arthroscopically assisted percutaneous screw fixation, which resulted in reduction of the suspensory apparatus and the glenoid fossa. CONCLUSION: Intra-articular glenoid involvement in scapular fractures mandates anatomical reduction through internal fixation. We highlight that this technique is of benefit in these injuries and is easy and quick to perform. Validated outcomes, in this case, have been excellent, with no adverse events.

Evaluation of early administration of simvastatin in the prevention and treatment of delirium in critically ill patients undergoing mechanical ventilation (MoDUS): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Delirium in critically ill patients is associated with poor clinical outcomes. Neuroinflammation might be an important mechanism in the pathogenesis of delirium, and since simvastatin has anti-inflammatory properties it might reduce delirium. We aimed to establish whether early treatment with simvastatin would decrease the time that survivors of critical illness spent in delirium or coma. METHODS: We undertook this randomised, double-blind, placebo-controlled trial in a general adult intensive care unit (ICU) in Watford General Hospital (Watford, UK). We enrolled critically ill patients (≥18 years) needing mechanical ventilation within 72 h of admission. We randomly assigned patients (1:1 ratio) to receive either simvastatin 80 mg or placebo daily for up to a maximum of 28 days, irrespective of coma or delirium status. We assessed delirium using the Confusion Assessment Method for the ICU (CAM-ICU). The primary outcome was number of days alive and was assessed as delirium-free and coma-free in the first 14 days after being randomly allocated to receive treatment or placebo. ICU clinical and research staff and patients were masked to treatment. We did intention-to-treat analyses with no extrapolation. This trial is registered with the International Standard Randomised Controlled Trial Registry, number ISRCTN89079989. FINDINGS: Between Feb 1, 2013, and July 29, 2016, 142 patients were randomly assigned to receive simvastatin (n=71) or placebo (n=71), and were included in the final analysis. The mean number of days alive without delirium and without coma at day 14 did not differ significantly between the two groups (5·7 days [SD 5·1] with simvastatin and 6·1 days [5·2] with placebo; mean difference 0·4 days, 95% CI -1·3 to 2·1; p=0·66). The most common adverse event was an elevated creatine kinase concentration to more than ten times the upper limit of normal (eight [11%] in the simvastatin group vs three [4%] in the placebo group p=0·208). No patient had a serious adverse event related to the study drug. INTERPRETATION: These results do not support the hypothesis that simvastatin modifies duration of delirium and coma in critically ill patients. FUNDING: National Institute for Health Research.

The use of Collagenase Clostridium Histolyticum in the management of Dupuytren's contracture-outcomes of a pilot study in a District General Hospital setting.

INTRODUCTION: Collagenase Clostridium Histolyticum (CCH) is a recognised treatment option for adult patients presenting with Dupuytren's contracture (DC). PATIENTS AND METHODS: Twenty male patients with established DC were treated using CCH. The average metacarpophalangeal (MCP) joint and proximal interphalangeal joint (PIP) contractures pre-treatment were 520 (range, 0 - 750) and 350 (range, 0 - 840) respectively. The average DASH score pre-treatment was 24.2 points (range, 0 - 68.2 points). Patients were reviewed at lmonth, 3months and at an average of 23 months (17 to 27 months). RESULTS: MCP joint contractures significantly improved compared to pre-treatment and the improvement was maintained at latest follow up. PIP joint contractures did significantly improve but to a lesser degree and there was no significant improvement compared to pre-treatment beyond 3months. A trend for MCP and PIP joint contracture recurrence was observed at latest follow up but did not reach statistical significance. DASH scores significantly improved from pre-treatment and the improvement was maintained at latest follow up. At 3months, the average patient satisfaction score was 9.5 (range, 6 - 10), which decreased to 8.6 (range, 6 - 10) at latest follow up. We estimated a potential cost saving of approximately £70,000 by treating 20 patients using CCH compared to inpatient operative fasciectomy. CONCLUSION: CCH is a useful option in the management of DC in appropriately selected patients. Cost-effectiveness in the treatment of DC should be carefully considered.

Is it necessary to embolise all spinal metastases from primary renal tumours?

INTRODUCTION: Spinal metastases secondary to renal cell carcinoma are associated with significant intra-operative blood loss. Our aim was to assess if embolisation reduced the intra-operative blood loss and transfusion requirement. METHODS: We performed a retrospective cohort study of 25 patients undergoing surgery between 2003 and 2011. RESULTS: 14 underwent pre-operative embolisation; 11 did not. There was no significant difference in intra-operative blood loss, 1336 ml vs 1492 ml in the non-embolised (p value = 0.116). 43% of embolised patients required an intra operative blood transfusion vs 27% in the non-embolised. CONCLUSION: Our results suggest that not all patients with spinal metastatic renal carcinoma require pre-operative embolisation.

A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services: the Northern Ireland Caries Prevention In Practice (NIC-PIP) trial.

BACKGROUND: Dental caries is the most common disease of childhood. The NHS guidelines promote preventative care in dental practices, particularly for young children. However, the cost-effectiveness of this policy has not been established. OBJECTIVE: To measure the effects and costs of a composite fluoride intervention designed to prevent caries in young children attending dental services. DESIGN: The study was a two-arm, parallel-group, randomised controlled trial, with an allocation ratio of 1 : 1. Randomisation was by clinical trials unit, using randomised permuted blocks. Children/families were not blinded; however, outcome assessment was blinded to group assessment. SETTING: The study took place in 22 NHS dental practices in Northern Ireland, UK. PARTICIPANTS: The study participants were children aged 2-3 years, who were caries free at baseline. INTERVENTIONS: The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. The control group received the prevention advice alone. MAIN OUTCOME MEASURES: The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were the number of decayed, missing or filled tooth surfaces in primary dentition (dmfs) in caries-active children, the number of episodes of pain, the number of extracted teeth and the costs of care. Adverse reactions (ARs) were recorded. RESULTS: A total of 1248 children (624 randomised to each group) were recruited and 1096 (549 in the intervention group and 547 in the control group) were included in the final analyses. A total of 87% of the intervention children and 85% of control children attended every 6-month visit (p = 0.77). In total, 187 (34%) children in the intervention group converted to caries active, compared with 213 (39%) in the control group [odds ratio (OR) 0.81, 95% confidence interval (CI) 0.64 to 1.04; p = 0.11]. The mean number of tooth surfaces affected by caries was 7.2 in the intervention group, compared with 9.6 in the control group (p = 0.007). There was no significant difference in the number of episodes of pain between groups (p = 0.81). However, 164 out of the total of 400 (41%) children who converted to caries active reported toothache, compared with 62 out of 696 (9%) caries-free children (OR 7.1 95% CI 5.1 to 9.9; p < 0.001). There was no statistically significant difference in the number of teeth extracted in caries-active children (p = 0.95). Ten children in the intervention group had ARs of a minor nature. The average direct dental care cost was £155.74 for the intervention group and £48.21 for the control group over 3 years (p < 0.05). The mean cost per carious surface avoided over the 3 years was estimated at £251.00. LIMITATIONS: The usual limitations of a trial such as generalisability and understanding the underlying reasons for the outcomes apply. There is no mean willingness-to-pay threshold available to enable assessment of value for money. CONCLUSIONS: A statistically significant effect could not be demonstrated for the primary outcome. Once caries develop, pain is likely. There was a statistically significant difference in dmfs in caries-active children in favour of the intervention. Although adequately powered, the effect size of the intervention was small and of questionable clinical and economic benefit. FUTURE WORK: Future work should assess the caries prevention effects of interventions to reduce sugar consumption at the population and individual levels. Interventions designed to arrest the disease once it is established need to be developed and tested in practice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36180119 and EudraCT 2009-010725-39. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 71. See the NIHR Journals Library website for further project information.

A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol.

BACKGROUND: Vascular dementia is the second most common cause of dementia affecting over seven million people worldwide, yet there are no licensed treatments. There is an urgent need for a clinical trial in this patient group. Subcortical ischaemic vascular dementia is the most common variant of vascular dementia. This randomised trial will investigate whether use of calcium channel blockade with amlodipine, a commonly used agent, can provide the first evidence-based pharmacological treatment for subcortical ischaemic vascular dementia. METHODS/DESIGN: This is a randomised controlled trial of calcium channel blockade with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT) to test the hypothesis that treatment with amlodipine can improve outcomes for these patients in a phase IIb, multi-centre, double-blind, placebo-controlled randomised trial. The primary outcome is the change from baseline to 12 months in the Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog). Secondary outcomes include cognitive function, executive function, clinical global impression of change, change in blood pressure, quantitative evaluation of lesion accrual based on magnetic resonance imaging (MRI), health-related quality of life, activities of daily living, non-cognitive dementia symptoms, care-giver burden and care-giver health-related quality of life, cost-effectiveness and institutionalisation. A total of 588 patients will be randomised in a 1:1 ratio to either amlodipine or placebo, recruited from sites across the UK and enrolled in the trial for 104 weeks. DISCUSSION: There are no treatments licensed for vascular dementia. The most common subtype is subcortical ischaemic vascular dementia (SIVD). This study is designed to investigate whether amlodipine can produce benefits compared to placebo in established SIVD. It is estimated that the numbers of people with VaD and SIVD will increase globally in the future and the results of this study should inform important treatment decisions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN31208535 . Registered on 7 March 2014.

A Firming Neck Cream Containing N-Acetyl Glucosamine Significantly Improves Signs of Aging on the Challenging Neck and Décolletage.

BACKGROUND: Noninvasive antiaging neck and décolletage treatments are highly sought after by aging patients. A topical cosmetic antiaging cream was formulated with skin matrix building and smoothing ingredients to help reverse visible signs of aging on the neck and décolletage, including laxity, crepiness, deep lines, and hyperpigmentation. OBJECTIVE: A clinical study was conducted to evaluate the efficacy and safety of the antiaging neck/décolletage cream over a 16-week treatment period. METHOD: Caucasian women with moderate texture (including wrinkles, fine lines, laxity, and/or crepiness) on the neck and hyperpigmentation on the décolletage used the test cream for 16 weeks. At weeks 0, 8, 12 and 16, the dermatologist investigator graded neck texture, décolletage texture and décolletage pigmentation using a 0-5 scale, and irritation/tolerability using a 0-4 scale. Subjects were photographed and provided self-assessment of their aging parameters as well as product tolerability. Chromameter measurements were collected in triplicate on the chest at weeks 0, 8, and 16 to quantitatively and objectively assess pigmentation. RESULTS: Forty-two women completed the study. All dermatologist-graded aging parameters were significantly improved at each time point, P<0.001. Chromameter measurements demonstrated significant improvements in brightness (L*) and redness (a*), P<0.05. Self-assessed aging parameters were significantly improved on the décolletage and neck, P<0.05. Digital photography demonstrated obvious antiaging effects including improved texture of neck and décolletage areas, reduced appearance of lines and wrinkles, reduced mottled hyperpigmentation, and a more youthful, firm appearance. The test cream was well-tolerated with no significant changes in irritation parameters throughout the study. CONCLUSION: The antiaging neck/décolletage cream delivered significant firming and smoothing effects with reduced appearance of hyperpigmentation and can be considered an effective topical homecare treatment option for patients seeking rejuvenation of this challenging area

Evaluating early administration of the hydroxymethylglutaryl-CoA reductase inhibitor simvastatin in the prevention and treatment of delirium in critically ill ventilated patients (MoDUS trial): study protocol for a randomized controlled trial.

BACKGROUND: The incidence of delirium in ventilated patients is estimated at up to 82%, and it is associated with longer intensive care and hospital stays, and long-term cognitive impairment and mortality. The pathophysiology of delirium has been linked with inflammation and neuronal apoptosis. Simvastatin has pleiotropic properties; it penetrates the brain and, as well as reducing cholesterol, reduces inflammation when used at clinically relevant doses over the short term. This is a single centre randomised, controlled trial which aims to test the hypothesis that treatment with simvastatin will modify delirium incidence and outcomes. METHODS/DESIGN: The ongoing study will include 142 adults admitted to the Watford General Hospital Intensive Care Unit who require mechanical ventilation in the first 72 hours of admission. The primary outcome is the number of delirium- and coma-free days in the first 14 days. Secondary outcomes include incidence of delirium, delirium- and coma-free days in the first 28 days, days in delirium and in coma at 14 and 28 days, number of ventilator-free days at 28 days, length of critical care and hospital stay, mortality, cognitive decline and healthcare resource use. Informed consent will be taken from patient's consultee before randomisation to receive either simvastatin (80 mg) or placebo once daily. Daily data will be recorded until day 28 after randomisation or until discharge from the ICU if sooner. Surviving patients will be followed up on at six months from discharge. Plasma and urine samples will be taken to investigate the biological effect of simvastatin on systemic markers of inflammation, as related to the number of delirium- and coma-free days, and the potential of cholinesterase activity and beta-amyloid as predictors of the risk of delirium and long-term cognitive impairment. DISCUSSION: This trial will test the efficacy of simvastatin on reducing delirium in the critically ill. If patients receiving the statin show a reduced number of days in delirium compared with the placebo group, the inflammatory theory implicated in the pathogenesis of delirium will be strengthened. TRIAL REGISTRATION: The trial was registered with the International Standard Randomised Controlled Trial Registry ( ISRCTN89079989 ) on 26 March 2013.

Are Interprofessional Roundtable Debriefings Useful in Decreasing ED Fall Rates? Findings From a Quality-Improvement Project.

UNLABELLED: There are more than 1 million patient falls each year in the United States. Falls are known to be a sign of poor health, are a marker of decline in function, and are associated with high morbidity. The objective of this study was to determine the effectiveness of a Falls Roundtable intervention for reducing the rates of patient falls in an urban academic trauma center emergency department. METHODS: We implemented a Falls Roundtable performance-improvement debriefing intervention in a single urban academic emergency department. To evaluate this intervention, we conducted a retrospective analysis of patient fall events 13 months before and 14 months after implementation. We evaluated pre- and post-intervention differences in the total number of assisted falls, unassisted falls, and rate of falls. RESULTS: Despite a slowly improving trend in falls after the intervention, there was no statistically significant improvement in the number of assisted falls, number of unassisted falls, or rate of falls. The Falls Roundtable intervention was helpful in identifying many additional actionable improvement opportunities in the emergency department. IMPLICATIONS FOR PRACTICE: The Falls Roundtable incident debriefing intervention alone does not appear to be an effective tool for falls prevention in the ED setting but may serve as an integral component of a multifaceted fall-reduction strategy.

Vertical axis dislocation with coronal fracture of the patella: A previously unreported injury pattern.

The patella usually dislocates laterally. Less commonly, intra-articular dislocation occurs about either the vertical or horizontal axis. Patellar fractures are generally transverse with varying degrees of comminution, and less frequently vertical in the sagittal plane. We present a 9-year follow-up of a previously undescribed coronal patellar fracture associated with vertical axis dislocation of the patella. The mechanism of this severe injury is described.