Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial.

Objectives: Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced intracapsular fractures on postoperative mobility and function compared with a standard lateral approach. Design: Pragmatic, superiority, multicenter, parallel-group, randomized controlled trial (with internal pilot). Participants, ward staff, and research staff conducting postoperative assessments were blinded to allocation. A CTU allocated treatments centrally using computer-generated lists. Setting: Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022. Participants: 244 adults (≥60 years) requiring hip hemiarthroplasty (122 allocated to each approach). 90 and 85 participants allocated to SPAIRE and lateral, respectively, had primary outcome data within the prespecified data collection window. Interventions: Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation. Main outcome measure: Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3 days), pain (3 days, 120 days), discharge destination, length of hospital stay, complications and mortality (within 120 days), quality of life and place of residence (120 days). Results: Participants' mean age was 84.6 years (SD 7.2); 168 (69%) were women. Primary outcome: little evidence of a difference in OHS at 120 days; adjusted mean difference (SPAIRE-lateral) -1.23 (95% CI -3.96 to 1.49, p=0.37). Secondary outcomes: indication of lower participant-reported pain at 3 days in SPAIRE arm; no differences between arms for remaining outcomes. Conclusions: Participants' mobility and function are similar in the short term (3 days) and longer term (120 days), whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to prefracture residence, survival within 120 days, or quality of life at 120 days. Participants receiving SPAIRE approach may experience less pain in the early postoperative period. Modifying the posterior approach in hip hemiarthroplasty to the SPAIRE approach gives equivalent patient outcomes to the lateral approach within 120 days. Trial registration number: NCT04095611.

An MRI study demonstrating consistent anatomic relation of central longitudinal artery and associated periosteal vessels with the medial femoral epicondyle and adductor tubercle-A visual landmark method for femoral tunnel placement in medial patellofemoral ligament reconstruction.

The two most common techniques to determine femoral tunnel placement during medial patellofemoral ligament (MPFL) reconstruction are radiographic and by palpation. Their intra/interobserver reliability is widely debated. Both techniques rely on identifying bony landmarks such as the medial epicondyle (ME) and adductor tubercle (AT) during surgery. During MPFL reconstructive surgery, the central longitudinal vessels (CLVs) are seen consistently. The aim of this study was to investigate the anatomic relationship of CLV to ME and AT and to determine if CLV might be used as a landmark during MPFL reconstruction. A retrospective review of MRI scans in skeletally mature patients was undertake. There were two groups, a PFI group that consisted of patients with a diagnosis of patellofemoral instabiliy (PFI) and a non-PFI group that underwent MRI scan for an alternative diagnosis. MRIs were measured for the CLV-ME-AT anatomy and relationship. Following exclusions, 50 patients were identified in each group. The CLV passed anterior to the AT and ME in all patients. ME morphology did not differ greatly between the groups except in the tubercle height, where there was statistically significant but not a clinically important difference (larger in the non-PFI group, 2.95 vs. 2.52 mm, p = 0.002). The CLV to ME tip distance was consistent between the groups (PFI group 3.8 mm and non-PFI group 3.9 mm). The CLV-ME-AT relationship remained consistent irrespective of patients' presenting pathology. The CLV consistently courses anterior to ME and AT. The CLV could be used as a vascular landmark assisting femoral tunnel placement during MPFL reconstruction.

Selection of patients with malignant melanoma for pelvic lymph node dissection (PLND) using CT-PET.

OBJECTIVES: In melanoma patients with positive pelvic nodes, pelvic lymph node dissection (PLND) to achieve fully resected disease status facilitates adjuvant-dose systemic therapy and avoids higher treatment doses with greater toxicity. This study aimed to test the accuracy of prediction of nodal involvement of the 2010 joint BAPRAS/BAD guidance compared with Positron Emission Tomography (CT-PET). METHODS: A retrospective review was undertaken of 26 melanoma patients undergoing PLND by a single surgeon between July 2012 and July 2020. The indications for performing PLND were in accordance with the 2010 guidance, but this was supplemented by CT-PET in 16/26 patients. RESULTS: Of the 26 patients undergoing PLND, 10 underwent surgery based upon the 2010 criteria alone and 16 underwent supplementary CT-PET. 17 patients had positive nodes on histology; of these, 13 had a positive CT-PET. Amongst node-negative patients, only one had a false positive CT-PET. CT-PET was 100% sensitive for pelvic nodal disease and 75% specific, with a positive predictive value for nodal involvement of 92%. Of the 10 patients who underwent PLND without CT-PET, only 4 had positive nodes while 6 patients had negative nodes. CONCLUSIONS: The 2010 guidelines remain broad and contributed to negative PLND in a third of our patients (9/26). Hence, the indications for performing PLND need to be revisited. Our series supports PET-CT as being 100% sensitive in the identification of pelvic nodal disease and 75% specific. We recommend that a positive PET-CT should be considered as the primary indication for PLND in melanoma patients.

Predictors of aspiration pneumonia: developing a new matrix for speech and language therapists.

INTRODUCTION: The contributing factors of aspiration pneumonia have been well documented. However, there are gaps in the literature regarding identifying the weight associated with each factor and the relationship between factors. METHOD: In this study, 20 potential predictors of aspiration pneumonia (with four additional variables) have been applied to historic Speech and Language Therapy records to greater understand the significance of each contributor of aspiration pneumonia. 152 cases with an oropharyngeal dysphagia, and a Speech and Language Therapy recommendation of eating and drinking with known aspiration and the associated potential risk of developing an aspiration pneumonia, were included in the data. These were inpatients and outpatients, and had various diagnoses but all had had a videofluoroscopy. RESULTS: Logistic regression analysis found seven factors that were individually significant in predicting the development of aspiration pneumonia with 84.93% sensitivity and 91.03% specificity DISCUSSION: Logistic regression and random forest analyses led to the proposal of a new matrix of predictors of aspiration pneumonia with respective scoring weights for individual and cumulative contributors (a direction for future research).

Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE.

BACKGROUND: The HemiSPAIRE trial is being conducted to determine whether a modified muscle sparing technique (SPAIRE-"Save Piriformis and Internus, Repairing Externus") in hip hemiarthroplasty brings clinical benefits compared to the standard lateral technique in adults aged 60 years or older, with a displaced intracapsular hip fracture. This article describes the detailed statistical analysis plan for the trial.  METHODS AND DESIGN: HemiSPAIRE is a definitive, pragmatic, superiority, multicentre, randomised controlled trial (with internal pilot) with two parallel groups. Participants, ward staff and all research staff involved in post-operative assessments are blinded to allocation. This article describes in detail (1) the primary and secondary outcomes; (2) the statistical analysis principles, including a survivor average causal effect (SACE) method chosen specifically to address the issue of potential bias from differential survival between trial arms, which was seen from data review by the Trial Steering Committee, the participants that will be included in each analysis, the covariates that will be included in each analysis, and how the results will be presented; (3) planned main analysis of the primary outcome; (4) planned analyses of the secondary outcomes; and (5) planned additional analyses of the primary and secondary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04095611. Registered on 19 September 2019.

Patellotrochlea Index in Normal Healthy Knees.

Patella alta is a common and significant abnormality responsible for many patellofemoral joint-related conditions. Many methods of patella height measurements are described; however, patellotrochear index (PTI) is the most logical method as it measures the direct relation between patella and trochlea. The aim of this study is to investigate PTI in normal healthy asymptomatic volunteers to understand the patellofemoral relation in normal knees. Twenty-five healthy volunteers underwent magnetic resonance imaging (MRI) scans of both knees. Two observers independently measured PTI on two different occasions at 6-week interval. Statistical analysis was performed to identify intra- and interobserver correlation between two observers and the mean value of PTI. Agreement analysis was performed according to Bland and Altman. Comparisons of means were made using paired t-tests. The mean age of 25 healthy volunteers was 21.28 years (19-23) with a male:female ratio of 14:11. The overall mean PTI value of all observations was 36.8% and pooled standard deviation (SD) 11.5%. Intraclass correlation (ICC) testing showed "good" interobserver ICC between two observers for PTI for both first (0.80) and second (0.84) set of measurements. There was "excellent" intraobserver correlation for two sets of measurements of PTI made by each first (0.96) and second (0.91) observer. Intraobserver repeatability for PTI was ± 0.07 and ± 0.1, respectively, for the first and second observer. Interobserver repeatability for PTI was ± 0.159 and ± 0.133, respectively, for the first and second set of measurements. Analysis of individual measurements of patella and trochlear articular cartilage revealed that the largest repeatability values were for trochlea measurements. The study reports that the average PTI in asymptomatic healthy knee utilizing current clinical MRI scanning conditions is 36.8%. This provides surgeons with a gold standard normal PTI value, which can serve as a target value in clinical diagnosis as well as surgical correction of patella height. There is good to excellent intra- and interobserver correlation with limited variability in assessing patella height using PTI on MRI scan.

Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial.

INTRODUCTION: Currently National Institute for Health and Care Excellence clinical guidelines in the UK suggest that surgeons performing partial hip replacements (hemiarthroplasty) should consider using the lateral approach. Alternatively, a newer, modified posterior approach using a muscle sparing technique named 'Save Piriformis and Internus, Repairing Externus' (SPAIRE) can be used leaving the major muscles intact. This randomised controlled trial (RCT) aims to compare the SPAIRE approach to the standard lateral approach, to determine if it allows patients to mobilise better and experience improved function after surgery. METHODS AND ANALYSIS: HemiSPAIRE is a two-arm, assessor-blinded, definitive pragmatic RCT with nested pilot and qualitative studies. Two hundred and twenty-eight participants with displaced intracapsular fractures requiring hip hemiarthroplasty will be individually randomised 1:1 to either the SPAIRE, or control (standard lateral approach) surgical procedure. Outcomes will be assessed at postoperative day 3 (POD3) and 120 (POD120). The primary outcome measure will be level of function and mobility using the Oxford Hip Score at POD120. Secondary outcomes include: De Morton Mobility Index (DEMMI), Cumulated Ambulatory Score and Numeric Pain Rating Scale (NPRS) at POD3; DEMMI, NPRS and EQ-5D-5L at POD120, complications, acute and total length of hospital stay, and mortality. Primary analysis will be on an intention-to-treat basis. Participant experiences of the impact of surgery and recovery period will be examined via up to 20 semi-structured telephone interviews. ETHICS AND DISSEMINATION: The protocol has been approved by Yorkshire and the Humber-Bradford Leeds Research Ethics Committee. Recruitment commenced in November 2019. Findings will be disseminated via research articles in peer-reviewed journals, presentations at conferences, public involvement events, patient groups and media releases. A summary of the trial findings will be shared with participants at the end of the study. TRIAL REGISTRATION NUMBER: NCT04095611.

Bone Marrow Oedema in the Knees of Asymptomatic High-Level Athletes: Prevalence and Associated Factors.

BACKGROUND: Bone marrow oedema (BMO), seen on magnetic resonance imaging, can be associated with various injuries to the knee but may also occur in asymptomatic athletes. The prevalence and causal factors for these observations are not well understood. The aim of this study was to determine the prevalence of BMO in asymptomatic knees of athletes, competing at a high level, and to investigate the associated factors. MATERIALS AND METHODS: Twenty-five asymptomatic university athletes, competing at regional to international level, were recruited. Bilateral knee magnetic resonance imaging was performed in each athlete (total 50 knee scans) at the end of their competitive season. Imaging studies were reported independently by two experienced consultant musculoskeletal radiologists. RESULTS: There was almost perfect agreement between reporters for diagnosis of BMO (κ = 0.896). Seven participants (28%) were found to have BMO (six in one knee and one bilaterally). The amount of time spent training, during the season, was significantly associated with the appearance of BMO (p < 0.05). CONCLUSION: The occurrence of BMO in asymptomatic knees of athletes is common (occurring in over one-quarter of knees) and may be associated with training intensity. This should be considered when treating athletes and deciding upon appropriate treatment plans.

The diagnostic accuracy of multiparametric magnetic resonance imaging before biopsy in the detection of prostate cancer.

OBJECTIVES: To determine the extent to which clinically significant prostate cancer (csPCa) can be detected in a routine National Health Service setting in men with no previous biopsy, when multiparametric magnetic resonance imaging (mpMRI) is introduced into the diagnostic pathway. PATIENTS AND METHODS: In all, 1 090 mpMRIs were performed between July 2013 and April 2016 in biopsy-naïve men with an abnormal prostate-specific antigen level and/or digital rectal examination. Data were collected from patient records at the Royal Devon and Exeter NHS Foundation Trust. mpMRI Prostate Imaging Reporting and Data System (PI-RADS) scores were compared to transperineal or transrectal ultrasonography (TRUS)-guided biopsy findings as the reference standard. csPCa was defined as Gleason score of ≥3+4. The diagnostic accuracy of mpMRI was also assessed. RESULTS: The mpMRI was interpretable in 1 023 men and 792 underwent biopsy, of which 106 were transperineal. The median number of cores taken in transperineal and TRUS-guided biopsy were 10 and 6, respectively. The detection rate of csPCa was 37%; csPCa rose from 15% of PI-RADS 1 and 2 to 86% of PI-RADS 5. The sensitivity, negative predictive value, specificity, and positive predictive value were 82%, 85%, 59% and 54%, respectively. The study is limited by its retrospective nature and lack of reporting of follow-up for 'missed cancers'. Men with low mpMRI PI-RADS were also less likely to undergo biopsy. Whilst this selection bias may overestimate the detection rate of csPCa, this reflects the shared decisions patients and clinicians make in day-to-day practice outside of research centres. CONCLUSION: In a routine clinical setting, the higher the mpMRI PI-RADS, the greater the detection rate of csPCa in biopsy-naïve men. A normal mpMRI does not exclude csPCa; however, mpMRI may have utility in informing shared-decision making on whether to proceed to biopsy and subsequent treatment.

Prediction of Scoliosis Curve Correction Using Pedicle Screw Constructs in AIS: A Comparison of Fulcrum Bend Radiographs and Traction Radiographs Under General Anesthesia.

STUDY DESIGN: Retrospective radiographic review. OBJECTIVES: Our objectives were to (1) compare the ability of fulcrum bend radiographs and traction radiographs under general anesthesia to predict correction of adolescent idiopathic scoliosis (AIS) using pedicle screw only constructs and (2) compare the fulcrum bend correction index (FBCI) with a new measurement: the traction correction index (TCI). METHODS: This is a retrospective radiographic review of 80 AIS patients (62 female and 18 male), who underwent scoliosis correction with pedicle screw only constructs. The mean age at surgery was 14 years (range 9-20 years). Radiographic analysis was carried out on the preoperative and immediate postoperative posteroanterior standing radiographs and the preoperative fulcrum bend radiographs and traction radiographs under general anesthesia. FBCI is calculated by dividing the correction rate by the fulcrum flexibility and TCI is calculated by dividing the correction rate by the traction flexibility. RESULTS: Preoperative mean Cobb angle of 63.9° was corrected to 25.8° postoperatively. The mean fulcrum bending Cobb angle was 37.6° and traction Cobb angle was 26.6°. The mean fulcrum flexibility was 41.1%, traction flexibility 58.4%, and correction rate 59.6%. The median FBCI was 137% and TCI was 104.3%. CONCLUSIONS: When comparing fulcrum bend and traction radiographs, we found the traction radiographs to be more predictive of curve correction in AIS using pedicle screw constructs. TCI takes into account the curve flexibility better than FBCI.

Exploring NursEs lived Experience of Discussions about Sexual health, with kidney patients in Devon (NEEDS).

AIM: The aim of the study is to gain a better understanding about the complexities of discussing sexuality with patients. DESIGN: The study will explore how nurses understand the phenomenon by using an Interpretive Phenomenological Approach; the technique encourages deep reflection and rich descriptions about lived experience. METHODS: Six nurses will be interviewed using iterative, open-ended questions with prompts to illicit rich data. PREDICTED RESULTS: Understand the support required to enable nurses to engage in deeper, more fulfilling conversations with patients about sexuality.

Assessing the accuracy of ultrasound estimation of gestational age during routine antenatal care in in vitro fertilization (IVF) pregnancies.

INTRODUCTION: In the UK an accurate gestational age is confirmed by ultrasound measured foetal crown rump length (CRL) at 11 + 2-14 + 1 weeks of gestation. The currently recommended Robinson and Fleming crown rump length reference chart was develop in 1975. Advances in ultrasound technology and standardized crown rump length measurement training could mean this is now out of date. Our study aimed to assess its accuracy in current routine antenatal care. METHODS: Retrospective data from 178 IVF pregnancies seen for routine antenatal care at a UK Regional Maternity Unit between 1 January 2006 and 1 January 2016 was retrieved. We compared ultrasound calculated crown rump length gestational age taken at the routine First Trimester Screening Clinic (FTSC) with the 'true' gestational age calculated from the known IVF fertilization date. RESULTS: We identified a systematic overestimation of gestational age by ultrasound using the currently recommended crown rump length reference chart when compared to IVF gestational age. The mean overestimation was 3.0 days (95% CI: 2.7 to 3.4), p < 0.001. A range of alternative ultrasound reference charts also generated a systematic overestimation, ranging from 1.6 to 2.9 days (p < 0.001, for each). CONCLUSIONS: The current crown rump length reference chart systematically overestimates gestational age by an average of three days when assessed in IVF pregnancies. A systematic overestimation was also identified in alternative crown rump length reference charts. These differences, although slight, were systematic with implications for the accuracy of gestational age estimation particularly in pregnancies at risk of pre-term delivery or growth restriction. Our findings need confirming in larger, non IVF cohorts and could lead to the need for an updated crown rump length reference chart.

3-phase Technicium-99m bone scanning in patients with pain in the hip region after cemented total hip replacement: a multicentre series of 100 cases.

INTRODUCTION: The aim of this study was to assess the benefit of a Technetium-99M (HDP) 3-phase bone scan (TPBS) as an additional diagnostic test in the evaluation of pain in the hip region following cemented total hip replacement (THR) surgery. METHODS: A retrospective study over a 24-month period was performed comprising 100 patients investigated with a TPBS. Investigations were summarised and analysed, and were classified as entirely normal, possibly abnormal, and definitely abnormal. RESULTS: 45% (45) of TPBSs were reported as being entirely normal, 50% (50) as possibly abnormal, and 5% (5) as definitely abnormal. During the 24-month study period 230 revision THR procedures were performed at our institution; 10% (24) were investigated with TPBS and 90% (206) were not. 29% (7/24) of patients investigated with a TPBS that subsequently underwent revision THR surgery had an entirely normal preoperative TPBS. 84% (38) with an abnormal TPBS were managed conservatively. A TPBS had a sensitivity of 29% (95% confidence interval (CI), 13%-51%) and a specificity of 50% (95% CI, 38%-62%) in the detection of infection, or loosening with concurrent infection. CONCLUSION: A TPBS should only be considered following clinical evaluation, serological investigation, diagnostic imaging and microbiological analysis of fluid obtained from arthrocentesis by a specialist revision arthroplasty surgeon. A TPBS may be useful in the situation where abnormal serology is present, but where repeated joint aspirations samples are inconclusive.

Pilot parallel randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people: 'STOPCUTS'.

BACKGROUND: Skin tears are common in older adults and those taking steroids and warfarin. They are traumatic, often blunt injuries caused by oblique knocks to the extremities. The epidermis may separate from the dermis or both layers from underlying tissues leaving a skin flap or total loss of tissue, which is painful and prone to infection. 'Dermatuff™' knee-length socks containing Kevlar fibres (used in stab-proof vests and motorcyclists' clothing) aim to prevent skin tears. The acceptability of the socks and the feasibility of a randomised controlled trial (RCT) had not been explored. METHODS: In this pilot parallel group RCT, 90 people at risk of skin-tear injury from Devon care homes and primary care were randomised to receive the socks or treatment as usual (TAU). The pilot aimed to estimate parameters to inform the design of a substantive trial and record professionals' views and participants' acceptability of the intervention and of study participation. RESULTS: Participants were randomised from July 2013 and followed up until February 2015. Community participants were easier to recruit than care homes residents but were 10 years younger on average and more active. To recruit 90 participants, 395 had to be approached overall as 77% were excluded or declined. Seventy-nine participants (88%) completed the trial and 27/44 (61%) wore the socks for 16 weeks. There were 31 skin tear injuries affecting 18 (20%) of the 90 participants. The TAU group received more injuries, more repeated episodes, and larger tears with greater severity. Common daily diary reasons for not wearing the socks included perceived warmth in hot weather or not being available (holiday, in hospital, bed rest). Resource use data were obtainable and indicated that sock wearing gave a reduction in treatment costs whilst well-completed questionnaires showed improvements in secondary outcomes. CONCLUSIONS: This pilot trial has successfully informed the design and conduct of a future definitive cost-effectiveness RCT. It would need to be conducted in primary care with 880 active at-risk, elderly patients (440 per arm). Skin tear incidence and quality of life (from EQ5D5L) over a 4-month period would be the primary and secondary outcomes respectively. TRIAL REGISTRATION: ISRCTN, ISRCTN96565376.

Does treatment by a specialist physiotherapist change pain and function in young adults with symptoms from femoroacetabular impingement? A pilot project for a randomised controlled trial.

AIM: Femoroacetabular impingement (FAI) is recognised as a source of hip pain but the effect of conservative treatment remains untested. This pilot study aimed to inform and evaluate the methods required to conduct a substantive trial comparing the effect of treatment by a physiotherapist versus routine care on the symptoms of FAI. DESIGN: A parallel group, pilot randomised controlled trial (RCT). SETTING: A single NHS acute hospital trust, Devon, England. PARTICIPANTS: 30 adults with symptomatic FAI were recruited. 23 (77%) completed the study. INTERVENTIONS: Intervention was 3 months of treatment by a specialist physiotherapist. The control group received routine care. MAIN OUTCOMES: Change in pain and function was measured using a Visual Analogue Scale, Non Arthritic Hip Score (NAHS), Lower Extremity Functional Score (LEFS) and Hip Outcome Score. RESULTS: Participants in the intervention arm undertook a personalised exercise programme to improve pelvic and femoral control plus advice on posture, activity pacing and pain relief. The mean change in NAHS for the intervention group was 12.7 (95% CI 4.7 to 20.7) and 1.8 (95% CI -5.3 to 9.0) in the control group; Median change in LEFS was 11.5 (95% CI 5.0 to 26.0) versus -1.0 (95% CI -7.0 to 4.0). This improvement in LEFS was beyond minimal clinically important difference in the intervention group. Pain scores improved marginally in both groups. CONCLUSIONS: Methodological strengths and weaknesses were successfully identified for a substantive study. Further research is needed to evaluate the relative influence of structural and neuromuscular features on symptoms of FAI and the role of conservative treatment.

First do no harm: pain relief for the peripheral venous cannulation of adults, a systematic review and network meta-analysis.

BACKGROUND: Peripheral venous cannulation is an everyday practice in hospitals, which many adults find painful. However, anaesthesia for cannulation is usually only offered to children. Inadequate pain relief is not only unpleasant for patients but may cause anxiety about further treatment and deter patients from seeking medical care in the future. The aim of this study is to discover the most effective local anaesthetic for adult peripheral venous cannulation and to find out how the pain of local anaesthetic application compares with that of unattenuated cannulation. METHODS: These aims are addressed through a systematic review, network meta-analysis and random-effects meta-analysis. Searching covered 12 databases including MEDLINE and EMBASE from 1990 to August 2015. The main included study design was RCTs. The primary outcome measure is self-reported pain, measured on a 100 mm visual analogue scale. RESULTS: The systematic review found 37 includable studies, 27 of which were suitable for network meta-analysis and two for random-effects meta-analysis. The results of the network meta-analysis indicate that none of the 17 anaesthetic considered had a very high probability of being the most effective when compared to each other; 2 % lidocaine had the highest probability (44 %). When the anaesthetics were compared to no treatment, the network meta-analysis showed that again 2 % lidocaine was estimated to be the most effective (mean difference -25.42 (95 % CI -32.25, -18.57). Other members of the 'caine' family were also estimated to be more effective than no treatment as were Ametop®, EMLA® and Rapydan® patch. The meta-analysis compared the pain of anaesthetic application with the unattenuated pain of cannulation. This found that all applications of local anaesthetic were less painful than cannulation without local anaesthetic. In particular a 1 % lidocaine injection was estimated to be -12.97 (95 % CI -15.71, -10.24) points (100 mm VAS) less painful than unattenuated cannulation. CONCLUSIONS: The pain of peripheral venous cannulation in adults can be successfully treated. The pain of application of any local anaesthetic is less than that of unattenuated cannulation. Local anaesthetic prior to cannulation should become normal practice and a marker of high quality care. PROTOCOL REGISTRATION: The protocol for the larger study was registered with PROSPERO no. CRD42012002093 .

Can clinical features be used to differentiate type 1 from type 2 diabetes? A systematic review of the literature.

OBJECTIVE: Clinicians predominantly use clinical features to differentiate type 1 from type 2 diabetes yet there are no evidence-based clinical criteria to aid classification of patients. Misclassification of diabetes is widespread (7-15% of cases), resulting in patients receiving inappropriate treatment. We sought to identify which clinical criteria could be used to discriminate type 1 and type 2 diabetes. DESIGN: Systematic review of all diagnostic accuracy studies published since 1979 using clinical criteria to predict insulin deficiency (measured by C-peptide). DATA SOURCES: 14 databases including: MEDLINE, MEDLINE in Process and EMBASE. The search strategy took the form of: (terms for diabetes) AND (terms for C-Peptide). ELIGIBILITY CRITERIA: Diagnostic accuracy studies of any routinely available clinical predictors against a reference standard of insulin deficiency defined by cut-offs of C-peptide concentrations. No restrictions on race, age, language or country of origin. RESULTS: 10,917 abstracts were screened, and 231 full texts reviewed. 11 studies met inclusion criteria, but varied by age, race, year and proportion of participants who were C-peptide negative. Age at diagnosis was the most discriminatory feature in 7/9 studies where it was assessed, with optimal cut-offs (>70% mean sensitivity and specificity) across studies being <30 years or <40 years. Use of/time to insulin treatment and body mass index (BMI) were also discriminatory. When combining features, BMI added little over age at diagnosis and/or time to insulin (<1% improvement in classification). CONCLUSIONS: Despite finding only 11 studies, and considerable heterogeneity between studies, age at diagnosis and time to insulin were consistently the most discriminatory criteria. BMI, despite being widely used in clinical practice, adds little to these two criteria. The criteria identified are similar to the Royal College of General Practitioners National Health Service (RCGP/NHS) Diabetes classification guidelines, which use age at diagnosis <35 years and time to insulin <6 m. Until further studies are carried out, these guidelines represent a suitable classification scheme. SYSTEMATIC REVIEW REGISTRATION: PROSPERO reference CRD42012001736.

Pilot randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people "STOPCUTS": study protocol.

BACKGROUND: Skin tears are traumatic injuries occurring mostly on the extremities due to shearing and friction forces that separate the epidermis and the dermis from underlying tissues. They are common and occur mostly in older adults and those taking medications that compromise skin integrity. Pretibial skin tears can develop into leg ulcers, which require lengthy, expensive treatment to heal. Traumatic injuries are the second most common type of wounds after pressure ulcers in care homes and are the commonest reason for older adults to require the attention of a community nurse. Common causes of skin tear injuries are bumping into furniture and other obstacles, using mobility aids, transfer to/from wheelchairs, getting in and out of bed and falls. No effective preventative measures currently exist but knee-length, protective socks are now available that contain impact-resistant Kevlar fibres (of the type used in stab-proof vests) and cushioning layers underneath. METHODS/DESIGN: In this pilot parallel group, randomised controlled trial, 90 people at risk of skin-tear injury will be randomised with equal allocation to receive the intervention or usual care. They will be recruited from care homes and from the community via general practices and a research volunteer database. Pilot outcomes include recruitment, eligibility, attrition, ascertainment of injuries and completion of outcome measures. Acceptability of the intervention and of study participation will be explored using semi-structured interviews. The proposed primary outcome for the future definitive trial is skin tear-free days. Secondary outcomes are skin tear severity, health status, specific skin-tears quality of life, capability and fear of falling, measured at baseline and the end of the study and in the event of a skin tear. DISCUSSION: The results of this study will be used to inform the development and design of a future randomised controlled trial to assess the effectiveness and cost-effectiveness of a unique and innovative approach to skin tear prevention. Approval was granted by the NRES - Cornwall and Plymouth Research Ethics Committee (13/SW/013). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN96565376.

Factors determining penetrance in familial atypical haemolytic uraemic syndrome.

BACKGROUND: Inherited abnormalities of complement are found in ∼60% of patients with atypical haemolytic uraemic syndrome (aHUS). Such abnormalities are not fully penetrant. In this study, we have estimated the penetrance of the disease in three families with a CFH mutation (c.3643C>G; p. Arg1215Gly) in whom a common lineage is probable. 25 individuals have been affected with aHUS with three peaks of incidence-early childhood (n=6), early adulthood (n=11) and late adulthood (n=8). Eighteen individuals who have not developed aHUS carry the mutation. METHODS: We estimated penetrance at the ages of 4, 27, 60 and 70 years as both a binary and a survival trait using MLINK and Mendel. We genotyped susceptibility factors in CFH, CD46 and CFHR1 in affected and unaffected carriers. RESULTS AND CONCLUSIONS: We found that the estimates of penetrance at the age of 4 years ranged from <0.01 to 0.10, at the age of 27 years from 0.16 to 0.29, at the age of 60 years from 0.39 to 0.51 and at the age of 70 years from 0.44 to 0.64. We found that the CFH haplotype on the allele not carrying the CFH mutation had a significant effect on disease penetrance. In this family, we did not find that the CD46 haplotypes had a significant effect on penetrance.