Overview of clinical outcome measures used in glaucoma randomised controlled trials (RCTs)

Background: In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Glaucoma is a chronic eye disease and the leading cause of irreversible blindness in the world. A variety of outcomes has been used and reported in glaucoma RCTs.

Objectives: The purpose of this review is to identify different clinical outcome measures used in glaucoma RCTs between January 2006 and March 2012.

Methods: A systematic review was conducted using standard methodology. We searched for RCTs in glaucoma published in English with no restrictions on the population type or size, or applied interventions. All clinical outcomes were included. Patient-reported, pharmacokinetic and economic outcomes were excluded.

Results: The search strategy identified 4288 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure (IOP) was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Amongst the IOPrelated measures, the most commonly used was mean IOP (n=143, 15% of all measures). Safety outcomes were commonly reported, in 145 RCTs (62%) whereas visual field outcomes were utilized in 38 RCTs (16%).

Conclusions: There is a large variability in clinical outcomes used for glaucoma RCTs and in the way each outcome is reported. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

Angels with dirty faces? European identity, politics of representation and recognition of Romani interests

The contradiction between acknowledgement of cultural differences and their accommodation in public has been a constant theme in studies of diverse societies. This review essay discusses five volumes that grapple with questions of Romani inclusion and the problems Roma face across Europe. The volumes under review point to problems faced by Romani communities and analyse the various legal, political and social challenges that situation of the Roma poses to institutions of contemporary societies. The essay reviews the challenging nature of the status of Roma as we move away from the one-sided towards more reciprocal relationship engagement of state with society in general, and the multiply excluded groups, in particular. The essay finds that the role Roma play in these relationships is either over-, or under-estimated by the literature, largely as a result of limited opportunities to acknowledge and, in effect, accommodate Roma who are rarely understood as actors in their own right.

Travelling without moving? Limits of European governance for Romani inclusion

The European Union's commitment to citizen participation in policymaking and implementation reflects a wider concern for securing Europe's ‘unity in diversity’. However, across its member-states, individuals belonging to the diverse linguistic, ethnic and social groups often referred to as ‘Roma’ find themselves excluded from political, social and economic participation in countries where they live. The past decade saw the appearance of a more concerted approach to improve the participation of individuals belonging to these groups in social and economic processes. This article examines what it refers to as the European Governance for Romani inclusion (EGRI), assessing policy steps undertaken at the European institutional level towards Romani inclusion and the tools for policy implementation. The paper concludes that the EGRI has offered only limited opportunities for the marginalised Roma to redress their exclusion.

When stereotype meets prejudice: Antiziganism in European Societies

Antiziganism is a widespread phenomenon in all European societies. Poor or rich, ‘postcommunist’ or ‘traditional’, North or South, with ‘lean’ or ‘thick’ welfare systems-all European societies demonstrate antiziganist prejudice.
All across Europe Romanis are among the poorest, most destitute, and most excluded communities. Widespread prejudice and stereotypical representations of Romani individuals limit their chances for participation in democratic decision making processes and their access to services. Unable to counteract majority stereotypes systematically, more often than not they remain on the fringes of society. This edited volume asks where these stereotypes and prejudices come from, why they are ubiquitous to all societies, and how pertinent their impact on antiziganist attitudes found in European societies really is.

Diagnostic accuracy of pulmonary host inflammatory mediators in the exclusion of ventilator-acquired pneumonia

Background: Excessive use of empirical antibiotics is common in critically ill patients. Rapid biomarker-based exclusion of infection may improve antibiotic stewardship in ventilator-acquired pneumonia (VAP). However, successful validation of the usefulness of potential markers in this setting is exceptionally rare.

Objectives: We sought to validate the capacity for specific host inflammatory mediators to exclude pneumonia in patients with suspected VAP. 

Methods: A prospective, multicentre, validation study of patients with suspected VAP was conducted in 12 intensive care units. VAP was confirmed following bronchoscopy by culture of a potential pathogen in bronchoalveolar lavage fluid (BALF) at >10⁴ colony forming units per millilitre (cfu/mL). Interleukin-1 beta (IL-1β), IL-8, matrix metalloproteinase-8 (MMP-8), MMP-9 and human neutrophil elastase (HNE) were quantified in BALF. Diagnostic utility was determined for biomarkers individually and in combination. 

Results: Paired BALF culture and biomarker results were available for 150 patients. 53 patients (35%) had VAP and 97 (65%) patients formed the non-VAP group. All biomarkers were significantly higher in the VAP group (p<0.001). The area under the receiver operator characteristic curve for IL-1β was 0.81; IL-8, 0.74; MMP-8, 0.76; MMP-9, 0.79 and HNE, 0.78. A combination of IL-1β and IL-8, at the optimal cut-point, excluded VAP with a sensitivity of 100%, a specificity of 44.3% and a post-test probability of 0% (95% CI 0% to 9.2%). 

Conclusions: Low BALF IL-1β in combination with IL-8 confidently excludes VAP and could form a rapid biomarker-based rule-out test, with the potential to improve antibiotic stewardship.

A Prospective Cohort Study of Body Size and Risk of Head and Neck Cancers in the NIH-AARP Diet and Health Study

Background: The association between body size and head and neck cancers (HNCA) is unclear, partly because of the biases in case–control studies. Methods: In the prospective NIH–AARP cohort study, 218,854 participants (132,288 men and 86,566 women), aged 50 to 71 years, were cancer free at baseline (1995 and 1996), and had valid anthropometric data. Cox proportional hazards regression was used to examine the associations between body size and HNCA, adjusted for current and past smoking habits, alcohol intake, education, race, and fruit and vegetable consumption, and reported as HR and 95% confidence intervals (CI). Results: Until December 31, 2006, 779 incident HNCAs occurred: 342 in the oral cavity, 120 in the oro- and hypopharynx, 265 in the larynx, 12 in the nasopharynx, and 40 at overlapping sites. There was an inverse association between HNCA and body mass index, which was almost exclusively among current smokers (HR = 0.76 per each 5 U increase; 95% CI, 0.63–0.93), and diminished as initial years of follow-up were excluded. We observed a direct association with waist-to-hip ratio (HR = 1.16 per 0.1 U increase; 95% CI, 1.03–1.31), particularly for cancers of the oral cavity (HR, 1.40; 95% CI, 1.17–1.67). Height was also directly associated with total HNCAs (P = 0.02), and oro- and hypopharyngeal cancers (P < 0.01). Conclusions: The risk of HNCAs was associated inversely with leanness among current smokers, and directly with abdominal obesity and height. Impact: Our study provides evidence that the association between leanness and risk of HNCAs may be due to effect modification by smoking. Cancer Epidemiol Biomarkers Prev; 23(11); 2422–9. ©2014 AACR.

Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment

This is the protocol for a review and there is no abstract. The objectives are as follows:

The primary objective of this review is to evaluate the effects of non-pharmacological interventions among cancer patients targeted at maintaining cognitive function or ameliorating cognitive impairment as a result of cancer or receipt of systemic cancer treatment (i.e. chemotherapy or hormonal therapies in isolation or combination with other treatments). Patients who have received treatments such as cranial radiation for central nervous system tumours or metastases are not the focus of this review and will be excluded.

A second objective is to evaluate the effectiveness of non-pharmacological interventions for improving non-cognitive outcomes e.g. quality of life among this population.

Thirdly, we will extract and analyse data regarding the duration of intervention effects.

Fourthly, we will examine each study to identify safety as an outcome and incorporate information on intervention safety where possible. Evidence for the review will be based on data from randomised trials.

European Union Non-Discrimination Law: Comparative Perspectives on Multidimensional Equality Law

EU equality law is multidimensional in being based on different rationales and concepts. Consequently, the concept of discrimination has become fragmented, with different instruments envisaging different scopes of protection. This raises questions as to the ability of EU law to address the situation of persons excluded on a number of grounds. This edited collection addresses the increasing complexity of European Equality Law from jurisprudential, sociological and political science perspectives. Internationally renowned researchers from Scandinavian, Continental and Central European countries and Britain analyse consequences of multiplying discrimination grounds within EU equality law, considering its multidimensionality and intersectionality. The contributors to the volume theorise the move from formal to substantive equality law and its interrelation to new forms of governance, demonstrating the specific combination of non-discrimination law with welfare state models which reveal the global implications of the European Union. The book will be of interest to academics and policy makers all over the world, in particular to those researching and studying law, political sciences and sociology with an interest in human rights, non discrimination law, contract and employment law or European studies.

Implant-retained overdentures did not have a significant improvement in dietary intake

DESIGN: Randomised controlled trial.

INTERVENTION: Patients aged 65 or above edentate for a minimum of five years, with sufficient bone for two implants in the anterior mandible, were recruited. Those with systemic disease that contraindicated implants or had a low mini-mental state evaluation score were excluded. Patients in both groups had a standard maxillary complete denture fabricated. Patients randomised to the treatment group received a two-implant mandibular overdenture while those in the control group received a standard mandibular complete denture. Three 24-hour dietary recalls were collected by telephone interviews at baseline and at 12 months.

RESULTS: 255 patients were randomised: 128 received a standard complete denture (CD) and 127 a two-implant mandibular overdenture (IOD). 127 patients were available at 12-month follow up, 114 in the CD group and 103 in the IOD group. No significant between-group differences were found.

CONCLUSIONS: Although there is much evidence supporting the adoption of two-implant mandibular overdenture (IOD) treatment as the standard of care for edentate patients, this evidence does not include an improvement in dietary intake at one year for medically healthy independent edentate elders when given no specific dietary counselling.

The Ocho Poetas Mexicanos and the marginalisation of Catholic authors in post-revolutionary Mexico

The group known as the Ocho Poetas Mexicanos were marginalised in post-revolutionary literary circles and remain largely forgotten by literary history because they were dismissed as Catholic authors by a literary establishment which favoured nation-building literature at a time when Catholicism was excluded from official constructions of nationhood. This article draws attention to the significant contribution made by group members to contemporary cultural life and re-evaluates the work they published in the 1955 anthology which announced their arrival onto the literary scene. An analysis of this collection demonstrates that there was scant justification for labelling the group as Catholic poets and suggests that they are best understood with reference to the “universal” strand of Mexican literature and as heirs to groups such as the Contemporáneos. The treatment of the Ocho Poetas provides important evidence of the way in which Catholic authors were marginalised in mid-twentieth century Mexico, even if they did not express religious beliefs in their work, and draws attention to the non-literary criteria which can come into play when evaluating texts.

Prevalence of refractive error in Europe: the European Eye Epidemiology (E3) Consortium

To estimate the prevalence of refractive error in adults across Europe. Refractive data (mean spherical equivalent) collected between 1990 and 2013 from fifteen population-based cohort and cross-sectional studies of the European Eye Epidemiology (E³) Consortium were combined in a random effects meta-analysis stratified by 5-year age intervals and gender. Participants were excluded if they were identified as having had cataract surgery, retinal detachment, refractive surgery or other factors that might influence refraction. Estimates of refractive error prevalence were obtained including the following classifications: myopia ≤−0.75 diopters (D), high myopia ≤−6D, hyperopia ≥1D and astigmatism ≥1D. Meta-analysis of refractive error was performed for 61,946 individuals from fifteen studies with median age ranging from 44 to 81 and minimal ethnic variation (98 % European ancestry). The age-standardised prevalences (using the 2010 European Standard Population, limited to those ≥25 and <90 years old) were: myopia 30.6 % [95 % confidence interval (CI) 30.4–30.9], high myopia 2.7 % (95 % CI 2.69–2.73), hyperopia 25.2 % (95 % CI 25.0–25.4) and astigmatism 23.9 % (95 % CI 23.7–24.1). Age-specific estimates revealed a high prevalence of myopia in younger participants [47.2 % (CI 41.8–52.5) in 25–29 years-olds]. Refractive error affects just over a half of European adults. The greatest burden of refractive error is due to myopia, with high prevalence rates in young adults. Using the 2010 European population estimates, we estimate there are 227.2 million people with myopia across Europe.

Does antenatal education prepare fathers for their role as birth partners and for parenthood?

A systematic review of the literature was undertaken to explore fathers' opinions and views on antenatal education and its effectiveness in preparing them for their role as birth partners and for parenthood. The findings are categorised under four key themes: outnumbered, excluded, anxious and uncertain, and preparedness. While research suggests that most fathers want to support their partners and be involved in the pregnancy, labour and birth of their baby, they are less likely to attend antenatal classes than women. While fathers who attend antenatal education classes value them, their experiences are not always as positive or helpful in preparing them for their role as birth partners or in parenthood. It was highlighted that men are more likely to feel unprepared when complications at birth arise. A common finding was that men would welcome the opportunity to focus on their individual needs.

Slopes of Avian Species-Area Relationships, Human Population Density, and Environmental Factors

There is increasing interest in how humans influence spatial patterns in biodiversity. One of the most frequently noted and marked of these patterns is the increase in species richness with area, the species-area relationship (SAR). SARs are used for a number of conservation purposes, including predicting extinction rates, setting conservation targets, and identifying biodiversity hotspots. Such applications can be improved by a detailed understanding of the factors promoting spatial variation in the slope of SARs, which is currently the subject of a vigorous debate. Moreover, very few studies have considered the anthropogenic influences on the slopes of SARs; this is particularly surprising given that in much of the world areas with high human population density are typically those with a high number of species, which generates conservation conflicts. Here we determine correlates of spatial variation in the slopes of species-area relationships, using the British avifauna as a case study. Whilst we focus on human population density, a widely used index of human activities, we also take into account (1) the rate of increase in habitat heterogeneity with increasing area, which is frequently proposed to drive SARs, (2) environmental energy availability, which may influence SARs by affecting species occupancy patterns, and (3) species richness. We consider environmental variables measured at both local (10 km x 10 km) and regional (290 km x 290 km) spatial grains, but find that the former consistently provides a better fit to the data. In our case study, the effect of species richness on the slope SARs appears to be scale dependent, being negative at local scales but positive at regional scales. In univariate tests, the slope of the SAR correlates negatively with human population density and environmental energy availability, and positively with the rate of increase in habitat heterogeneity. We conducted two sets of multiple regression analyses, with and without species richness as a predictor. When species richness is included it exerts a dominant effect, but when it is excluded temperature has the dominant effect on the slope of the SAR, and the effects of other predictors are marginal.

The influence of comorbidity on the risk of access-related bacteremia in chronic hemodialysis patients.

Access-related bacteremia is an important cause of morbidity in chronic hemodialysis patients. The incidence of bacteremia is higher in patients dialyzing through a tunneled central venous catheter (TCVC) compared with an arteriovenous fistula (AVF). Our aim was to explore if this is explained by patient comorbidity. Two groups of chronic hemodialysis outpatients were compared: all patients who dialyzed through a TCVC at any time during 2003 and were fit enough to subsequently have a functioning AVF or renal transplant even if it was after 2003 (Group 1; n=93); and all patients who dialyzed through a TCVC in 2003 and were not fit enough to have a functioning AVF or renal transplant (Group 2; n=119). Episodes of bacteremia (n=71) were identified and those not related to access were excluded. Patients in Group 1 were younger than Group 2 (57.5 years vs. 64.8 years; P=0.001). The incidences of bacteremia in Groups 1 and 2 were, respectively, 0.31 and 0.44 episodes per 1000 patient days while dialyzing through an AVF (P=0.77), and 2.21 and 2.27 per 1000 days while dialyzing through a TCVC (P=0.91). The 3-year actual survival from January 1, 2003 to January 1, 2006 was significantly higher in Group 1 than in Group 2 (80.6% vs. 26.1%; P<0.0001) confirming the higher comorbidity of the patients in Group 2. Patients dialyzing through a TCVC (compared with an AVF) have a significantly higher risk of access-related bacteremia, irrespective of comorbidity.

The health profile of football/soccer players in Northern Ireland - a review of the uefa pre-participation medical screening procedure.

BACKGROUND:
It is compulsory that domestic football/soccer teams in UEFA competitions organise players' pre-participation medicals. Although screening guidelines have been established, these remain controversial. The findings of medical examinations can have lasting consequences for athletes and doctors. No previous studies have reported UEFA pre-participation screening results in semi-professional footballers. This study aims to further knowledge regarding 'normal' data in this population.

METHOD:
Retrospective audit and analysis of records of pre-season medicals for all male first-team players at one semi-professional Northern Ireland Premiership team between 2009-2012. Medicals were conducted by the club doctor following the UEFA proforma. Height, weight, blood pressure (BP), full blood count (FBC), dipstick urinalysis and resting electrocardiogram (ECG) were conducted by an independent nurse. Only one ECG must be documented during a player's career; other tests are repeated yearly.

RESULTS:
89 medicals from 47 players (6 goalkeepers, 11 defenders, 22 midfielders and 8 attackers; mean age 25.0 years (SD 4.86)) were reviewed. Mean height of the players was 179.3 cm (SD 5.90) with a mean weight of 77.6 kg (SD 10.5). Of 89 urine dipsticks, 7 were positive for protein; all 7 were normal on repeat testing following 48 hours of rest. Of 40 ECGs (mean ventricular rate 61.2 bpm (SD 11.6)), one was referred to cardiology (right bundle branch block; prolonged Q-T interval). No players were excluded from participation.

CONCLUSIONS:
This study provides important information about 'normal' values in a population of semi-professional footballers. Urinalysis showing protein is not uncommon but is likely to be normal on repeat testing.