Consensus on post COVID in the Spanish national health system: Results of the CIBERPOSTCOVID eDelphi study.

BACKGROUND: In 2021, the Spanish Ministry of Health launched the CIBERPOSTCOVID project to establish what post COVID was. The present study reports the level of agreement among stakeholders on post COVID and its clinical and diagnostic characteristics in the Spanish health system. METHODS: The agreement on post COVID among clinicians, public health managers, researchers and patients' representatives was explored in a real-time, asynchronous online Delphi. In a two-wave consensus, respondents rated from 1 (total disagreement) to 6 (total agreement) 67 statements related to terminology, duration, etiology, symptoms, impact on quality of life, severity, elements to facilitate diagnosis, applicability in the pediatric population, and risk factors. Consensus was reached when 70 % of ratings for a statement were 5 or 6, with an interquartile range equal or less than 1. FINDINGS: A total of 333 professionals and patients participated in this eDelphi study. There was agreement that post COVID was "a set of multi-organic symptoms that persist or fluctuate after acute COVID-19 infection and are not attributable to other causes" with a minimum duration of 3 months. The highest levels of agreement were found in the most frequent symptoms and its impacts on everyday activities. Aspects related to the diagnostic process and the measurement of its severity reached a lower level of consensus. There was agreement on the need to rule out previous health problems and assess severity using validated functional scales. However, no agreement was reached on the risk factors or specific features in the pediatric population. INTERPRETATION: This policy-based consensus study has allowed the characterization of post COVID generating collective intelligence and has contributed to an operational definition applicable in clinical practice, health services management and useful for research purposes in Spain and abroad. Agreements are consistent with existing evidence and reference institutions at European and international level.

Traumatic stress symptoms among Spanish healthcare workers during the COVID-19 pandemic: a prospective study.

AIM: To investigate the occurrence of traumatic stress symptoms (TSS) among healthcare workers active during the COVID-19 pandemic and to obtain insight as to which pandemic-related stressful experiences are associated with onset and persistence of traumatic stress. METHODS: This is a multicenter prospective cohort study. Spanish healthcare workers (N = 4,809) participated at an initial assessment (i.e., just after the first wave of the Spain COVID-19 pandemic) and at a 4-month follow-up assessment using web-based surveys. Logistic regression investigated associations of 19 pandemic-related stressful experiences across four domains (infection-related, work-related, health-related and financial) with TSS prevalence, incidence and persistence, including simulations of population attributable risk proportions (PARP). RESULTS: Thirty-day TSS prevalence at T1 was 22.1%. Four-month incidence and persistence were 11.6% and 54.2%, respectively. Auxiliary nurses had highest rates of TSS prevalence (35.1%) and incidence (16.1%). All 19 pandemic-related stressful experiences under study were associated with TSS prevalence or incidence, especially experiences from the domains of health-related (PARP range 88.4-95.6%) and work-related stressful experiences (PARP range 76.8-86.5%). Nine stressful experiences were also associated with TSS persistence, of which having patient(s) in care who died from COVID-19 had the strongest association. This association remained significant after adjusting for co-occurring depression and anxiety. CONCLUSIONS: TSSs among Spanish healthcare workers active during the COVID-19 pandemic are common and associated with various pandemic-related stressful experiences. Future research should investigate if these stressful experiences represent truly traumatic experiences and carry risk for the development of post-traumatic stress disorder.

Anti-vascular endothelial growth factor for proliferative diabetic retinopathy.

BACKGROUND: Proliferative diabetic retinopathy (PDR) is an advanced complication of diabetic retinopathy that can cause blindness. It consists of the presence of new vessels in the retina and vitreous haemorrhage. Although panretinal photocoagulation (PRP) is the treatment of choice for PDR, it has secondary effects that can affect vision. Anti-vascular endothelial growth factor (anti-VEGF), which produces an inhibition of vascular proliferation, could improve the vision of people with PDR. OBJECTIVES: To assess the effectiveness and safety of anti-VEGFs for PDR and summarise any relevant economic evaluations of their use. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov, and the WHO ICTRP. We did not use any date or language restrictions. We last searched the electronic databases on 1 June 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing anti-VEGFs to another active treatment, sham treatment, or no treatment for people with PDR. We also included studies that assessed the combination of anti-VEGFs with other treatments. We excluded studies that used anti-VEGFs in people undergoing vitrectomy. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data, and assessed the risk of bias (RoB) for all included trials. We calculated the risk ratio (RR) or the mean difference (MD), and 95% confidence intervals (CI). We used GRADE to assess the certainty of evidence. MAIN RESULTS: We included 15 new studies in this update, bringing the total to 23 RCTs with 1755 participants (2334 eyes). Forty-five per cent of participants were women and 55% were men, with a mean age of 56 years (range 48 to 77 years). The mean glycosylated haemoglobin (Hb1Ac) was 8.45% for the PRP group and 8.25% for people receiving anti-VEGFs alone or in combination. Twelve studies included people with PDR, and participants in 11 studies had high-risk PDR (HRPDR). Twelve studies were of bevacizumab, seven of ranibizumab, one of conbercept, two of pegaptanib, and one of aflibercept. The mean number of participants per RCT was 76 (ranging from 15 to 305). Most studies had an unclear or high RoB, mainly in the blinding of interventions and outcome assessors. A few studies had selective reporting and attrition bias. No study reported loss or gain of 3 or more lines of visual acuity (VA) at 12 months. Anti-VEGFs ± PRP probably increase VA compared with PRP alone (mean difference (MD) -0.08 logMAR, 95% CI -0.12 to -0.04; I2 = 28%; 10 RCTS, 1172 eyes; moderate-certainty evidence). Anti-VEGFs ± PRP may increase regression of new vessels (MD -4.14 mm2, 95% CI -6.84 to -1.43; I2 = 75%; 4 RCTS, 189 eyes; low-certainty evidence) and probably increase a complete regression of new vessels (RR 1.63, 95% CI 1.19 to 2.24; I2 = 46%; 5 RCTS, 405 eyes; moderate-certainty evidence). Anti-VEGFs ± PRP probably reduce vitreous haemorrhage (RR 0.72, 95% CI 0.57 to 0.90; I2 = 0%; 6 RCTS, 1008 eyes; moderate-certainty evidence). Anti-VEGFs ± PRP may reduce the need for vitrectomy compared with eyes that received PRP alone (RR 0.67, 95% CI 0.49 to 0.93; I2 = 43%; 8 RCTs, 1248 eyes; low-certainty evidence). Anti-VEGFs ± PRP may result in little to no difference in the quality of life compared with PRP alone (MD 0.62, 95% CI -3.99 to 5.23; I2 = 0%; 2 RCTs, 382 participants; low-certainty evidence). We do not know if anti-VEGFs ± PRP compared with PRP alone had an impact on adverse events (very low-certainty evidence). We did not find differences in visual acuity in subgroup analyses comparing the type of anti-VEGFs, the severity of the disease (PDR versus HRPDR), time to follow-up (< 12 months versus 12 or more months), and treatment with anti-VEGFs + PRP versus anti-VEGFs alone. The main reasons for downgrading the certainty of evidence included a high RoB, imprecision, and inconsistency of effect estimates. AUTHORS' CONCLUSIONS: Anti-VEGFs ± PRP compared with PRP alone probably increase visual acuity, but the degree of improvement is not clinically meaningful. Regarding secondary outcomes, anti-VEGFs ± PRP produce a regression of new vessels, reduce vitreous haemorrhage, and may reduce the need for vitrectomy compared with eyes that received PRP alone. We do not know if anti-VEGFs ± PRP have an impact on the incidence of adverse events and they may have little or no effect on patients' quality of life. Carefully designed and conducted clinical trials are required, assessing the optimal schedule of anti-VEGFs alone compared with PRP, and with a longer follow-up.

Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights.

BACKGROUND: The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE). METHODS: A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015-2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. We analyzed the SSR variation using the DoA estimated from RCTs. RESULTS: Sixty-three of 134 publications that reported event rates and the therapy effect in all component endpoints were included in the quantitative synthesis. The most frequent combination was death, AMI, and revascularization (n = 20; 31.8%). The correlation between death and AMI, estimated from 5 trials¸ oscillated between - 0.02 and 0.31. SSR varied from 14,602 in the scenario with the strongest correlation to 12,259 in the scenario with the weakest correlation; the relative impact was 16%. CONCLUSIONS: The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.

Applying the behavior change wheel to design de-implementation strategies to reduce low-value statin prescription in primary prevention of cardiovascular disease in primary care.

Introduction: A substantial proportion of individuals with low cardiovascular risk receive inappropriate statin prescription for primary prevention of cardiovascular disease (CVD) instead of the evidence-based recommendations to promote healthy lifestyle behaviors. This study reports on the structured process performed to design targeted de-implementation strategies to reduce inappropriate prescription of statins and to increase healthy lifestyle promotion in low cardiovascular risk patients in Primary Care (PC). Methods: A formative study was conducted based on the Theoretical Domains Framework and the Behavior Change Wheel (BCW). It comprised semi-structured interviews with PC professionals to define the problem in behavioral terms; focus groups with Family Physicians and patients to identify the determinants (barriers and facilitators) of inappropriate statin prescription and of healthy lifestyle promotion practice; mapping of behavioral change interventions operationalized as de-implementation strategies for addressing identified determinants; and consensus techniques for prioritization of strategies based on perceived effectiveness, feasibility and acceptability. Results: Identified key determinants of statin prescription and healthy lifestyle promotion were: the lack of time and clinical inertia, external resources, patients' preferences and characteristics, limitation of available clinical tools and guidelines, social pressures, fears about negative consequences of not treating, and lack of skills and training of professionals. Fourteen potential de-implementation strategies were mapped to the identified determinants and the following were prioritized: 1) non-reflective decision assistance strategies based on reminders and decision support tools for helping clinical decision-making; 2) decision information strategies based on the principles of knowledge dissemination (e.g., corporative diffusion of evidence-based Clinical Practice Guidelines and Pathways for CVD primary prevention); 3) reflective decision-making restructuring strategies (i.e., audit and feedback provided along with intention formation interventions). Conclusions: This study supports the usefulness of the BCW to guide the design and development of de-implementation strategies targeting the determinants of clinicians' decision-making processes to favor the abandonment of low-value practices and the uptake of those recommended for CVD primary prevention in low-risk patients. Further research to evaluate the feasibility and effectiveness of selected strategies is warranted. Clinical trial registration: Sanchez A. De-implementation of Low-value Pharmacological Prescriptions (De-imFAR). ClinicalTrials.gov, Identifier: NCT04022850. Registered July 17, 2019. In: ClinicalTrials.gov. Bethesda (MD): U.S. National Library of Medicine (NLM). Available from: https://www.clinicaltrials.gov/ct2/show/NCT04022850.

Prognostic models for mortality after cardiac surgery in patients with infective endocarditis: a systematic review and aggregation of prediction models.

BACKGROUND: There are several prognostic models to estimate the risk of mortality after surgery for active infective endocarditis (IE). However, these models incorporate different predictors and their performance is uncertain. OBJECTIVE: We systematically reviewed and critically appraised all available prediction models of postoperative mortality in patients undergoing surgery for IE, and aggregated them into a meta-model. DATA SOURCES: We searched Medline and EMBASE databases from inception to June 2020. STUDY ELIGIBILITY CRITERIA: We included studies that developed or updated a prognostic model of postoperative mortality in patient with IE. METHODS: We assessed the risk of bias of the models using PROBAST (Prediction model Risk Of Bias ASsessment Tool) and we aggregated them into an aggregate meta-model based on stacked regressions and optimized it for a nationwide registry of IE patients. The meta-model performance was assessed using bootstrap validation methods and adjusted for optimism. RESULTS: We identified 11 prognostic models for postoperative mortality. Eight models had a high risk of bias. The meta-model included weighted predictors from the remaining three models (EndoSCORE, specific ES-I and specific ES-II), which were not rated as high risk of bias and provided full model equations. Additionally, two variables (age and infectious agent) that had been modelled differently across studies, were estimated based on the nationwide registry. The performance of the meta-model was better than the original three models, with the corresponding performance measures: C-statistics 0.79 (95% CI 0.76-0.82), calibration slope 0.98 (95% CI 0.86-1.13) and calibration-in-the-large -0.05 (95% CI -0.20 to 0.11). CONCLUSIONS: The meta-model outperformed published models and showed a robust predictive capacity for predicting the individualized risk of postoperative mortality in patients with IE. PROTOCOL REGISTRATION: PROSPERO (registration number CRD42020192602).

Mental health impact of the first wave of COVID-19 pandemic on Spanish healthcare workers: A large cross-sectional survey.

INTRODUCTION: Healthcare workers are vulnerable to adverse mental health impacts of the COVID-19 pandemic. We assessed prevalence of mental disorders and associated factors during the first wave of the pandemic among healthcare professionals in Spain. METHODS: All workers in 18 healthcare institutions (6 AACC) in Spain were invited to web-based surveys assessing individual characteristics, COVID-19 infection status and exposure, and mental health status (May 5 - September 7, 2020). We report: probable current mental disorders (Major Depressive Disorder-MDD- [PHQ-8≥10], Generalized Anxiety Disorder-GAD- [GAD-7≥10], Panic attacks, Posttraumatic Stress Disorder -PTSD- [PCL-5≥7]; and Substance Use Disorder -SUD-[CAGE-AID≥2]. Severe disability assessed by the Sheehan Disability Scale was used to identify probable "disabling" current mental disorders. RESULTS: 9,138 healthcare workers participated. Prevalence of screen-positive disorder: 28.1% MDD; 22.5% GAD, 24.0% Panic; 22.2% PTSD; and 6.2% SUD. Overall 45.7% presented any current and 14.5% any disabling current mental disorder. Workers with pre-pandemic lifetime mental disorders had almost twice the prevalence than those without. Adjusting for all other variables, odds of any disabling mental disorder were: prior lifetime disorders (TUS: OR=5.74; 95%CI 2.53-13.03; Mood: OR=3.23; 95%CI:2.27-4.60; Anxiety: OR=3.03; 95%CI:2.53-3.62); age category 18-29 years (OR=1.36; 95%CI:1.02-1.82), caring "all of the time" for COVID-19 patients (OR=5.19; 95%CI: 3.61-7.46), female gender (OR=1.58; 95%CI: 1.27-1.96) and having being in quarantine or isolated (OR= 1.60; 95CI:1.31-1.95). CONCLUSIONS: One in seven Spanish healthcare workers screened positive for a disabling mental disorder during the first wave of the COVID-19 pandemic. Workers reporting pre-pandemic lifetime mental disorders, those frequently exposed to COVID-19 patients, infected or quarantined/isolated, female workers, and auxiliary nurses should be considered groups in need of mental health monitoring and support.

Appropriateness of surgery performed for abdominal aortic aneurysm at tertiary hospitals in Spain.

BACKGROUND: The aim of this study was to analyze the appropriateness of the type of repair (open or endovascular) performed for abdominal aortic aneurysm (AAA) in five university hospitals in Spain, according to evidence-based recommendations. METHODS: A multicenter, retrospective cross-sectional study of patients with AAA who underwent elective open surgical repair (OSR) or endovascular aneurysm repair (EVAR). Data were collected on demographic and clinical variables and type of surgical repair. A pair of vascular surgeons from each participating hospital performed a blinded assessment based on GRADE recommendations. The concordance between the two evaluators and the agreement between their evidence-based recommendation and the procedure performed were assessed. RESULTS: A total of 186 patients were selected; 179 were included. Mean age was 72.5 years (standard deviation [SD], 8.4), mean Charlson Comorbidity Index (CCI) was 2.04 (SD, 1.9). OSR was performed in 53.2% (N.=99) and EVAR in 46.8% (N.=87) of cases. Overall, 65.9% (118/179) of interventions performed were considered appropriate: 50% (47/94) of OSRs and 83.5% (71/85) of EVARs. The patient characteristics were similar for all the hospitals, but the chosen surgical technique did show significant differences among these centers. There were no significant differences among the hospitals in the proportion of cases judged as appropriate, either overall (P=0.346) or for each type of procedure (P=0.531 and P=0.538 for OSR and EVAR, respectively). CONCLUSIONS: In this study, most of the AAA repairs performed were appropriate according to GRADE recommendations. A higher proportion of EVARs were considered appropriate than OSRs. Choice of AAA repair should be standardized using evidence-based clinical practice guidelines, while incorporating patient preferences, to reduce the existing variability and ensure appropriate selection of AAA repair technique.

Thirty-day suicidal thoughts and behaviors among hospital workers during the first wave of the Spain COVID-19 outbreak.

BACKGROUND: Healthcare workers are a key occupational group at risk for suicidal thoughts and behaviors (STB). We investigated the prevalence and correlates of STB among hospital workers during the first wave of the Spain COVID-19 outbreak (March-July 2020). METHODS: Data come from the baseline assessment of a cohort of Spanish hospital workers (n = 5450), recruited from 10 hospitals just after the height of the coronavirus disease 2019 (COVID-19) outbreak (May 5-July 23, 2020). Web-based self-report surveys assessed 30-day STB, individual characteristics, and potentially modifiable contextual factors related to hospital workers' work and financial situation. RESULTS: Thirty-day STB prevalence was estimated at 8.4% (4.9% passive ideation only, 3.5% active ideation with or without a plan or attempt). A total of n = 6 professionals attempted suicide in the past 30 days. In adjusted models, 30-day STB remained significantly associated with pre-pandemic lifetime mood (odds ratio [OR] = 2.92) and anxiety disorder (OR = 1.90). Significant modifiable factors included a perceived lack of coordination, communication, personnel, or supervision at work (population-attributable risk proportion [PARP] = 50.5%), and financial stress (PARP = 44.1%). CONCLUSIONS AND RELEVANCE: Thirty-day STB among hospital workers during the first wave of the Spain COVID-19 outbreak was high. Hospital preparedness for virus outbreaks should be increased, and strong governmental policy response is needed to increase financial security among hospital workers.

Three-dimensional ultrasonography for advanced neurosonography (neurosofe-3D): Validation of a brain volume acquisition guideline.

INTRODUCTION: This study aimed to evaluate the quality of the brain volumes acquired following an evidence-based guideline for the acquisition of brain volumes. MATERIAL AND METHODS: This was a prospective multicenter study. Five centers recruited five cases each, acquiring two volumes per case, at different gestational age ranges. From the collected volumes, 10 operators performed an advanced neurosonography of each case. The evaluable anatomic structures were counted in each volume and expressed as a percentage. The results were compared with those obtained in a previous study where no recommendations had been made for the acquisition of the volumes. RESULTS: Five hundred evaluations were included in the study. In the axial plane, 91.5% of the structures were satisfactorily evaluated, 81.8% in the coronal plane and 89.9% in the sagittal plane. These results were significantly better than those obtained in a previous study where the volumes had been acquired without any guidelines and the percentage of evaluable structures were 80% (P < .001), 67.1% (P < .001) and 55.1% (P < .001) in the axial, coronal and sagittal planes, respectively. CONCLUSIONS: The application of an evidence-based guideline for the acquisition of brain volumes improves the quality of these by increasing the number of evaluable structures in the volume.

Mental health impact of the first wave of COVID-19 pandemic on Spanish healthcare workers: A large cross-sectional survey.

INTRODUCTION: Healthcare workers are vulnerable to adverse mental health impacts of the COVID-19 pandemic. We assessed prevalence of mental disorders and associated factors during the first wave of the pandemic among healthcare professionals in Spain. METHODS: All workers in 18 healthcare institutions (6 AACC) in Spain were invited to web-based surveys assessing individual characteristics, COVID-19 infection status and exposure, and mental health status (May 5 - September 7, 2020). We report: probable current mental disorders (Major Depressive Disorder-MDD- [PHQ-8≥10], Generalized Anxiety Disorder-GAD- [GAD-7≥10], Panic attacks, Posttraumatic Stress Disorder -PTSD- [PCL-5≥7]; and Substance Use Disorder -SUD-[CAGE-AID≥2]. Severe disability assessed by the Sheehan Disability Scale was used to identify probable "disabling" current mental disorders. RESULTS: 9,138 healthcare workers participated. Prevalence of screen-positive disorder: 28.1% MDD; 22.5% GAD, 24.0% Panic; 22.2% PTSD; and 6.2% SUD. Overall 45.7% presented any current and 14.5% any disabling current mental disorder. Workers with pre-pandemic lifetime mental disorders had almost twice the prevalence than those without. Adjusting for all other variables, odds of any disabling mental disorder were: prior lifetime disorders (TUS: OR=5.74; 95%CI 2.53-13.03; Mood: OR=3.23; 95%CI:2.27-4.60; Anxiety: OR=3.03; 95%CI:2.53-3.62); age category 18-29 years (OR=1.36; 95%CI:1.02-1.82), caring "all of the time" for COVID-19 patients (OR=5.19; 95%CI: 3.61-7.46), female gender (OR=1.58; 95%CI: 1.27-1.96) and having being in quarantine or isolated (OR= 1.60; 95CI:1.31-1.95). CONCLUSIONS: One in seven Spanish healthcare workers screened positive for a disabling mental disorder during the first wave of the COVID-19 pandemic. Workers reporting pre-pandemic lifetime mental disorders, those frequently exposed to COVID-19 patients, infected or quarantined/isolated, female workers, and auxiliary nurses should be considered groups in need of mental health monitoring and support.

Patient opinion of analgesia during external cephalic version at term in singleton pregnancy.

To assess the opinion and the level of satisfaction of patients concerning analgesia during external cephalic version (ECV), we present the results of a survey of 120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing remifentanil and nitrous oxide. Overall, 110 (91.7%) women said they would repeat the procedure and 111 (92.5%) that they would recommend it to another pregnant woman, with no significant differences by type of analgesia. The administration and sense of comfort were rated better in the remifentanil group (p < .01). In conclusion, the use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women.Impact statementWhat is already known on this subject? ECV is commonly a painful manoeuvre for the woman. This pain triggers maternal reactive abdominal muscle contraction and involuntary abdominal tensing, reducing the likelihood of successful version and causing some women to reject the technique.What do the results of this study add? The use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women. The sense of comfort during ECV was also significantly better in the remifentanil group, probably because of its greater analgesic power and greater comfort during its administration.What are the implications of these findings for clinical practice and/or further research? ECV should be carried out under analgesia, when available, not only to decrease pain but also to encourage wider adoption of the technique and enable more women to benefit from it.

Outcomes Associated With Inferior Vena Cava Filters Among Patients With Thromboembolic Recurrence During Anticoagulant Therapy.

OBJECTIVES: The aim of this study was to assess the effectiveness of inferior vena cava (IVC) filter use among patients who develop recurrent symptomatic venous thromboembolism (VTE) on anticoagulant therapy. BACKGROUND: There is a lack of efficacy evidence of IVC filter therapy in patients with VTE recurrence on anticoagulant therapy. METHODS: In this cohort study of patients with acute VTE identified from the RIETE (Registro Informatizado de la Enfermedad Tromboembólica) registry, the associations between IVC filter placement for VTE recurrence in the first 3 months of anticoagulant therapy and the outcomes of all-cause mortality, pulmonary embolism (PE)-related mortality, second recurrent VTE, and major bleeding rates through 30 days after diagnosis of recurrence were assessed. RESULTS: Among 17 patients treated with filters and 49 matched patients treated without filters for VTE recurrence that presented as deep vein thrombosis, propensity score-matched groups showed no significant differences in death for filter insertion compared with no insertion (17.7% vs. 12.2%; p = 0.56). Among 48 patients treated with filters and 91 matched patients treated without filters for VTE recurrence that presented as PE, propensity score-matched groups showed a significant decrease in all-cause death for filter insertion compared with no insertion (2.1% vs. 25.3%; p = 0.02). The PE-related mortality rate was not significantly lower for filter insertion than no insertion (2.1% vs. 17.6%; p = 0.08), though the point estimates markedly differed. CONCLUSIONS: Among patients with VTE recurrence during the first 3 months of anticoagulant therapy, IVC filter insertion was not associated with a survival benefit in patients who recurred with deep vein thrombosis, although it was associated with a lower risk for all-cause death in patients who recurred with PE.

Three dimensional ultrasonography for advanced neurosonography (Neurosofe-3d). Analysis of acquisition-related factors influencing the quality of the brain volumes.

OBJECTIVE: To evaluate the acquisition-related factors influencing the quality of the brain volumes for further study of advanced neurosonography. METHODS: This was a prospective multicentre study. Five centres were asked to include five cases each, acquiring two volumes per case, at different gestational ages. Ten operators performed an advanced neurosonography per case. The potential influence of the following factors on the number of evaluable structures was assessed: vaginal/ abdominal acquisition, position of the head, gestational age, subjective quality of the volume and the acquiring operator itself. RESULTS: Four hundred and thirty-two evaluations were included in the study. A total of 80% of the structures were evaluated satisfactorily in the axial plane, 67.1% and 55.1% in the coronal and sagittal plane, respectively. Sagittal volumes acquired transvaginally had a better quality than those acquired transabdominally. Gestational age affected the quality of axial and sagittal volumes (p < 0.001), and the best quality was obtained between 20 and 27 weeks. In axial and sagittal volumes, the head position influenced the percentage of structures visualized (p < 0.001, p < 0.001). CONCLUSIONS: Factors affecting the quality of the volume for advanced neurosonography are gestational age, fetal head position, transvaginal acquisition in sagittal volumes, the acquiring operator and the subjective quality of the volume. © 2016 John Wiley & Sons, Ltd.

Increased pain relief with remifentanil does not improve the success rate of external cephalic version: a randomized controlled trial.

INTRODUCTION: Our objective was to compare the effect of two pain relief methods (remifentanil vs. nitrous oxide) on the success rate of external cephalic version. MATERIAL AND METHODS: We conducted a randomized open label parallel-group controlled single-center clinical trial with sequential design, at Cruces University Hospital, Spain. Singleton pregnancies in noncephalic presentation at term that were referred for external cephalic version were assigned according to a balanced (1:1) restricted randomization scheme to analgesic treatment with remifentanil or nitrous oxide during the procedure. The primary endpoint was external cephalic version success rate. Secondary endpoints were adverse event rate, degree of pain, cesarean rate and perinatal outcomes. RESULTS: The trial was stopped early after the second interim analysis due to a very low likelihood of finding substantial differences in efficacy (futility). The external cephalic version success rate was the same in the two arms (31/60, 51.7%) with 120 women recruited, 60 in each arm. The mean pain score was significantly lower in the remifentanil group (3.2 ± 2.4 vs. 6.0 ± 2.3; p < 0.01). No differences were found in external cephalic version-related complications. There was a trend toward a higher frequency of adverse effects in the remifentanil group (18.3% vs. 6.7%, p = 0.10), with a significantly higher incidence rate (21.7 events/100 women vs. 6.7 events/100 women with nitrous oxide, p = 0.03). All reported adverse events were mild and reversible. CONCLUSIONS: Remifentanil for analgesia decreased external cephalic version-related pain but did not increase the success rate of external cephalic version at term and appeared to be associated with an increased frequency of mild adverse effects.

Valor pronóstico de la biopsia renal preimplante en donantes fallecidos de edad avanzada en la función renal al año del trasplante / Prognostic utility of preimplantation kidney biopsy from deceased older donors in first year post-transplant renal function

Antecedentes: La biopsia renal preimplante puede aportar información útil evolutiva postrasplante. Objetivo: Analizar el valor pronóstico de la biopsia renal de donantes de edad avanzada respecto al filtrado glomerular estimado MDRD-4 (FGe) al año del trasplante. Métodos: Estudiamos a 124 receptores de trasplante renal de donantes fallecidos de ≥60 años, con biopsia renal preimplante. Los trasplantes fueron realizados en nuestro centro, entre marzo del 2008 y mayo del 2012. Las biopsias se valoraron según el baremo propuesto por O’Valle et al. y se categorizaron en 3 grupos: 0-3, 4-5, 6-8 puntos. Se descartaron los riñones con una puntuación >8. El 77% de los donantes tenía ≥70 años. Resultados: El FGe medio (DE) del grupo 6-8 al año del trasplante: 38,5 (14,1) mL/min/1,73m2 fue menor que el del grupo 4-5: 46,3 (15,7) (p=0,03) y del grupo 0-3: 49,6 (12,5) (p=0,04). Se registraron 7 (19%) pacientes con FGe<30mL/min/1,73m2 en el grupo 6-8 vs. 8 (14%) en el grupo 4-5 y ninguno en el grupo 0-3 (p=0,17). En el análisis de regresión logística, OR (IC 95%), que valoró los pacientes con FGe<30mL/min/1,73m2 al año del trasplante, la función retrasada del injerto (6,3 [1,9-21,3]) y el rechazo agudo (5,8 [1,1-31]) fueron significativos. La puntuación del daño histológico de las biopsias, grupo 6-8 vs. 0-5, presentó un OR ajustado no significativo de 2,2 (0,7-7,3). Conclusiones: Los riñones con mayor afectación histológica presentaron un menor FGe al año del trasplante. La función renal retrasada del injerto y el rechazo fueron factores de riesgo significativos de un bajo FGe al año del trasplante (AU)

Background: Preimplantation renal biopsy provides potentially valuable information about post-transplant renal function. Objective: To assess the prognostic value of preimplantation kidney biopsy from older donors in determining 1-year post-transplant estimated glomerular filtration rate MDRD-4 (eGFR). Methods: We evaluated a cohort of 124 renal transplant recipients from deceased donors ≥60 years old, performed at our center between March 2008 and May 2012. Biopsies were assessed by applying the score proposed by O’Valle et al. The overall score was stratified into 3 levels: 0-3, 4-5 and 6-8 points. Kidneys scoring > 8 points were discarded. A total of 77% of the donors were ≥70 years. Results: One year post-transplant, mean eGFR (SD) was lower in transplant recipients with 6-8 points (38.5 [14.1] mL/min/1.73m2) than in the group scoring 4-5 points (46.3 [15.7] [p=0.03]) and the group scoring 0-3 (49.6 [12.5] [P=.04]). Seven patients (19%) had eGFR <30mL/min/1.73m2 1 year post-transplant in group 6-8 vs. 8 (14%) in group 4-5 and none in group 0-3. In the logistic regression, OR (95% IC), to determine patients with 1-year post-transplant eGFR (<30mL/min/1.73m2), delayed graft function (6.3 [1.9-21.3]) and acute rejection (5.8 [1.1-31]), were significant. The adjusted OR of biopsy score group 6-8 vs. 0-5, was 2.2 (0.7-7.3). Conclusions: Allografts with higher pathologic score in preimplantation renal biopsy were associated with a worse 1-year post-transplant eGFR. Delayed graft function and acute rejection were significant risk factors for 1-year post-transplant low eGFR (AU)

Prognostic utility of preimplantation kidney biopsy from deceased older donors in first year post-transplant renal function.

BACKGROUND: Preimplantation renal biopsy provides potentially valuable information about post-transplant renal function. OBJECTIVE: To assess the prognostic value of preimplantation kidney biopsy from older donors in determining 1-year post-transplant estimated glomerular filtration rate MDRD-4 (eGFR). METHODS: We evaluated a cohort of 124 renal transplant recipients from deceased donors ≥60 years old, performed at our center between March 2008 and May 2012. Biopsies were assessed by applying the score proposed by O'Valle et al. The overall score was stratified into 3 levels: 0-3, 4-5 and 6-8 points. Kidneys scoring > 8 points were discarded. A total of 77% of the donors were ≥70 years. RESULTS: One year post-transplant, mean eGFR (SD) was lower in transplant recipients with 6-8 points (38.5 [14.1] mL/min/1.73m(2)) than in the group scoring 4-5 points (46.3 [15.7] [p=0.03]) and the group scoring 0-3 (49.6 [12.5] [P=.04]). Seven patients (19%) had eGFR <30mL/min/1.73m(2) 1 year post-transplant in group 6-8 vs. 8 (14%) in group 4-5 and none in group 0-3. In the logistic regression, OR (95% IC), to determine patients with 1-year post-transplant eGFR (<30mL/min/1.73m(2)), delayed graft function (6.3 [1.9-21.3]) and acute rejection (5.8 [1.1-31]), were significant. The adjusted OR of biopsy score group 6-8 vs. 0-5, was 2.2 (0.7-7.3). CONCLUSIONS: Allografts with higher pathologic score in preimplantation renal biopsy were associated with a worse 1-year post-transplant eGFR. Delayed graft function and acute rejection were significant risk factors for 1-year post-transplant low eGFR.

Probability of cesarean delivery after successful external cephalic version.

OBJECTIVE: To identify factors associated with cesarean delivery following successful external cephalic version (ECV). METHODS: In a prospective study, data were obtained for ECV procedures performed at Cruces University Hospital, Spain, between March 2002 and June 2012. Women with a singleton pregnancy who had a successful, uncomplicated ECV and whose delivery was assisted at the study hospital, with the fetus in cephalic presentation, were included. A multivariate model of risk factors of cesarean delivery was developed. RESULTS: Among 627 women included, 92 (14.7%) delivered by cesarean. A cesarean was performed among 33 (8.5%) of 387 women with spontaneous labor versus 59 (24.6%) of 240 who were induced (P < 0.001). Multivariate analysis showed that higher BMI (P = 0.006), labor induction (P = 0.001), and prior cesarean (P < 0.001) were associated with cesarean. Time between ECV and delivery was inversely associated with probability of cesarean during the first 2 weeks. Thus, the probabilities of cesarean delivery on the first day were 0.53 (95% CI 0.35-0.71) and 0.34 (95% CI 0.18-0.51) following induced and spontaneous labor, respectively. On the seventh day, the probabilities were 0.23 (95% CI 0.15-0.32) and 0.12 (95% CI 0.07-0.18), respectively. CONCLUSION: Following ECV, induction of labor, an interval of less than 2 weeks to delivery, BMI, and previous cesarean were associated with an increased risk of cesarean.

Should PET/CT be implemented in the routine imaging work-up of locally advanced head and neck squamous cell carcinoma? A prospective analysis.

PURPOSE: The objective of this study was to determine the incremental staging information provided by positron emission tomography/computed tomography (PET/CT) and its impact on management plans in patients with untreated stage III-IV head and neck squamous cell carcinoma (HNSCC). METHODS: We prospectively studied, between September 2011 and February 2013, 84 consecutive patients [median age 63.5 years (39-84); 73 men] with histologically confirmed HNSCC. First, based on a conventional work-up (physical examination, CT imaging of the head, neck and chest), the multidisciplinary Head and Neck Tumour Board documented the TNM stage and a management plan for each patient, outlining the modalities to be used, including surgery, radiation therapy (RT), chemotherapy or a combination. After release of the PET/CT results, new TNM staging and management plans were agreed on by the multidisciplinary Tumour Board. Any changes in stage or intended management due to the PET/CT findings were then analysed. The impact on patient management was classified as: low (treatment modality, delivery and intent unchanged), moderate (change within the same treatment modality: type of surgery, radiation technique/dose) or high (change in treatment intent and/or treatment modality → curative to palliative, or surgery to chemoradiation or detection of unknown primary tumour or a synchronous second primary tumour). TNM stage was validated by histopathological analysis, additional imaging or follow-up. Accuracy of the conventional and PET/CT-based staging was compared using McNemar's test. RESULTS: Conventional and PET/CT stages were discordant in 32/84 (38 %) cases: the T stage in 2/32 (6.2 %), the N stage in 21/32 (65.7 %) and the M stage 9/32 (28.1 %). Patient management was altered in 22/84 (26 %) patients, with a moderate impact in 8 (9.5 %) patients and high impact in 14 (16.6 %) patients. PET/CT TNM classification was significantly more accurate (92.5 vs 73.7 %) than conventional staging with a p value < 0.001 (McNemar's test). CONCLUSION: PET/CT should be implemented in the routine imaging work-up of stage III-IV HNSCC.

Anti-vascular endothelial growth factor for proliferative diabetic retinopathy.

BACKGROUND: Proliferative diabetic retinopathy (PDR) is a complication of diabetic retinopathy that can cause blindness. Although panretinal photocoagulation (PRP) is the treatment of choice for PDR, it has secondary effects that can affect vision. An alternative treatment such as anti-vascular endothelial growth factor (anti-VEGF), which produces an inhibition of vascular proliferation, could improve the vision of people with PDR. OBJECTIVES: To assess the effectiveness and safety of anti-VEGFs for PDR. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to April 2014), EMBASE (January 1980 to April 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 April 2014. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing anti-VEGFs to another active treatment, sham treatment or no treatment for people with PDR. We also included studies that assessed the combination of anti-VEGFs with other treatments. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias for all included trials. We calculated the risk ratio (RR) or the mean difference (MD), and 95% confidence intervals (CI). MAIN RESULTS: We included 18 RCTs with 1005 participants (1131 eyes) of whom 57% were men. The median number of participants per RCT was 40 (range 15 to 261). The studies took place in Asia (three studies), Europe (two studies), the Middle East (seven studies), North America (three studies) and South America (three studies). Eight RCTs recruited people eligible for PRP, nine RCTs enrolled people with diabetes requiring vitrectomy and one RCT recruited people undergoing cataract surgery. The median follow-up was six months (range one to 12 months). Seven studies were at high risk of bias and the remainder were unclear risk of bias in one or more domains.Very low quality evidence from one study of 61 people showed that people treated with bevacizumab and PRP were less likely to lose 3 or more lines of visual acuity at 12 months compared with people treated with PRP alone (RR 0.19, 95% CI 0.05 to 0.81). People treated with anti-VEGF had an increased chance of gaining 3 or more lines of visual acuity but the effect was imprecise and compatible with no effect or being less likely to gain vision (RR 6.78, 95% CI 0.37 to 125.95). No other study reported these two outcomes. On average, people treated with anti-VEGF (bevacizumab, pegaptanib or ranibizumab) had better visual acuity at 12 months compared with people not receiving anti-VEGF (MD -0.07 logMAR, 95% CI -0.12 to -0.02; 5 RCTs, 373 participants, low quality evidence). There was some evidence to suggest a regression of PDR with smaller leakage on fluorescein angiography but it was difficult to estimate a pooled result from the two trials reporting this outcome. People receiving anti-VEGF were less likely to have vitreous or pre-retinal haemorrhage at 12 months (RR 0.32, 95% CI 0.16 to 0.65; 3 RCTs, 342 participants, low quality evidence). No study reported on fluorescein leakage or quality of life.All of the nine trials of anti-VEGF before or during vitrectomy investigated bevacizumab; most studies investigated bevacizumab before vitrectomy, one study investigated bevacizumab during surgery.People treated with bevacizumab and vitrectomy were less likely to lose 3 or more lines of visual acuity at 12 months compared with people given vitrectomy alone but the effect was imprecise and compatible with no effect or being more likely to lose vision (RR 0.49, 95% CI 0.08 to 3.14; 3 RCTs, 94 participants, low quality evidence). People treated with bevacizumab were more likely to gain 3 or more lines of visual acuity (RR 1.62, 95% CI 1.20 to 2.17; 3 RCTs, 94 participants, low quality evidence). On average, people treated with bevacizumab had better visual acuity at 12 months compared with people not receiving bevacizumab but there was uncertainty in the estimate (the CIs included 0; i.e. were compatible with no effect, and there was considerable inconsistency between studies; MD -0.24 logMAR, 95% CI -0.50 to 0.01; 6 RCTs, 335 participants, I(2) = 67%; low quality evidence). People receiving bevacizumab were less likely to have vitreous or pre-retinal haemorrhage at 12 months (RR 0.30, 95% CI 0.18 to 0.52; 7 RCTs, 393 participants, low quality evidence). No study reported on quality of life.Reasons for downgrading the quality of the evidence included risk of bias in included studies, imprecision of the estimates, inconsistency of effect estimates and indirectness (few studies reported at 12 months).Adverse effects were rarely reported and there was no evidence for any increased risk with anti-VEGF but given the relatively few studies that reported these, and the low event rate, the power of the analysis to detect any differences was low. AUTHORS' CONCLUSIONS: There was very low or low quality evidence from RCTs for the efficacy and safety of anti-VEGF agents when used to treat PDR over and above current standard treatments. However, the results suggest that anti-VEGFs can reduce the risk of intraocular bleeding in people with PDR. Further carefully designed clinical trials should be able to improve this evidence.