bluuebunny/crossref_metadata_2025_split huggingface dataset:
Research Governance: Regulating Risk and Reducing Harm?
Authors: Shaw Sara , Barrett Geraldine 
Published: November 2017

Risk assessment can be thought of as the lens through which we anticipate the consequences of research and the impact of the actions of researchers. The way in which risk of harm is managed in research is strongly influenced by the surrounding social and political environment, leading to differences in national and local styles of regulation and review. Different research studies carry different risks, so systems for review and approval must adapt to the question being asked and the nature of the study. Researchers can never wholly guarantee safety in any research but participants and researchers must be offered reasonable protection within any study, with appropriate arrangements in place should something go wrong.
Do shock absorbing insoles in recruits undertaking high levels of physical activity reduce lower limb injury? A randomized controlled trial
Authors: Withnall Richard , Eastaugh Joanne , Freemantle Nick 
Published: November 2017

Objectives To assess the benefits, if any, of the use of shock absorbing insoles in reducing lower limb injury among Air Force recruits, and to assess the differences, if any, in the efficacy of two commonly available shock absorbing insoles. Design Randomized controlled trial. Setting: RAF Halton, UK. Site of all basic training for RAF personnel. Participants: 1205 recruits participating in basic training between 17 September 2003 and 7 April 2004. Interventions: Participants were randomized to receive either standard issue Saran non-shock absorbing insoles, or shock absorbing Sorbothane or Poron insoles, on a 1:1:1 basis. Main Outcome Measures The primary outcome measure was withdrawal from training for lower limb injury. The two primary comparisons were shock absorbing insole versus non-shock absorbing insole, and Sorbothane versus Poron (comparison of different shock absorbing insoles). Secondary outcomes were medical withdrawals for reasons other than those qualifying for the primary outcome measure. Results When comparing the non-shock absorbing insole to the shock absorbing insoles 72/401 participants (18.0%) allocated to Saran insoles were removed from training because of a qualifying lower limb injury, compared with 149/ 804 (18.5%) allocated to the shock absorbing insole (Sorbothane or Poron), odds ratio 1.04 (95% CI 0.75 to 1.44; P=0.87). When comparing the two shock absorbing insole 73/ 421 participants (17.3%) randomized to Sorbothane were removed from training because of a qualifying lower limb injury, compared with 76/383 for Poron (19.8%), odds ratio 0.85 (95% CI 0.58 to 1.23; P=0.37). Conclusions Similar rates of lower limb injuries were observed for all insoles (shock absorbing and non-shock absorbing) in the trial. The trial provides no support for a change in policy to the use of shock absorbing insoles for military recruits.
Association of Population and Practice Factors with pOtentially Avoidable Admission Rates for Chronic Diseases in London: Cross Sectional Analysis
Authors: Saxena Sonia , George Julie , Barber Julie , Fitzpatrick Justine , Majeed Azeem 
Published: November 2017

Objectives: To examine the association between underlying ill health, material deprivation and primary care supply factors and hospital admission rates for potentially avoidable admissions in primary care trusts in London. Design: Cross sectional analysis at primary care trusts level using routine data from multiple sources. Setting: All 31 primary care trusts in London with a total resident population of 7 million patients. Main outcome measures: Age-standardized hospital admission rates for asthma, diabetes, heart failure, hypertension and chronic obstructive pulmonary disease. Results: Admission rates varied widely for the conditions examined across the 31 primary care trusts. In 2001, age adjusted admission rates for asthma varied from 76 to 189 per 100 000 and for diabetes from 38 to 183 per 100 000. There was a significant association between higher admission rates and measures of underlying ill health and material deprivation but not quantitative measures of primary care service provision. Provision of specialist chronic disease services in primary care for diabetes but not for asthma were significantly associated with reduced admission rates. There was no association of prescribing levels in primary care trusts with admission rates for any of the conditions examined. Conclusions: Although hospital admission for some chronic diseases is potentially avoidable and rates of hospital admission for these conditions are possible indicators of the quality of care, they should be interpreted in conjunction with measures of population composition and deprivation. Failure to do this may result in primary care trusts and general practitioners being criticized for aspects of health care utilization that are not under their direct control.
Risk of Cardiovascular Events and Celecoxib: a Systematic Review and Meta-Analysis
Authors: Caldwell Brent , Aldington Sarah , Weatherall Mark , Shirtcliffe Philippa , Beasley Richard 
Published: November 2017

Objectives To examine whether the increased risk of cardiovascular events with rofecoxib represents a class effect of cyclooxygenase-2 (COX-2) specific inhibitors. Design Systematic review and meta-analysis of randomized double-blind clinical trials of celecoxib of at least 6 weeks’ duration and presented data on serious cardiovascular thromboembolic events. Data sources included six bibliographic databases, the relevant files of the United States Food and Drug Administration, and pharmaceutical company websites. Main outcome measures Pooled fixed effects estimates of the odds ratios for risk of cardiovascular events with celecoxib compared with comparator treatment were calculated using the inverse variance weight method. The main outcome measure was myocardial infarction. Results Four placebo-controlled trials with 4422 patients were included in the primary meta-analysis comparing celecoxib with placebo. The odds ratio of myocardial infarction with celecoxib compared to placebo was 2.26 (95% confidence interval 1.0 to 5.1). For composite cardiovascular events [odd ratio 1.38 (95% CI 0.91 to 2.10)], cardiovascular deaths [OR 1.06 (95% CI 0.38 to 2.95)] and stroke [OR 1.0 (95% CI 0.51 to 1.84)] there was no significant increase in risk with celecoxib. The secondary meta-analysis which included a total of six studies (with placebo, diclofenac, ibuprofen, and paracetamol as comparators) of 12 780 patients, showed similar findings with a significant increased risk with celecoxib for myocardial infarction [OR 1.88 (95% CI 1.15 to 3.08)] but not other outcome measures. Conclusion The available data indicate an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors.
Open Access Publishing and Author-Pays Business Models: A Survey of Authors’ Knowledge and Perceptions
Authors: Schroter Sara , Tite Leanne 
Published: November 2017

Objectives We aimed to assess journal authors’ current knowledge and perceptions of open access and author-pays publishing. Design An electronic survey. Setting Authors of research papers submitted to BMJ, Archives of Disease in Childhood, and Journal of Medical Genetics in 2004. Main outcome measures Familiarity with and perceptions of open access and author-pays publishing. Results: 468/1113 (42%) responded. Prior to definitions being provided, 47% (222/468) and 38% (176/468) reported they were familiar with the terms ‘open access’ and ‘authorpays’ publishing, respectively. Some who did not at first recognize the terms, did claim to recognize them when they were defined. Only 10% (49/468) had submitted to an author-pays journal. Compared with non-open access subscription-based journals, 35% agreed that open access author-pays journals have a greater capacity to publish more content making it easier to get published, 27% thought they had lower impact factors, 31% thought they had faster and more timely publicaitons, and 46% agreed that people will think anyone can pay to get published. 55% (256/468) thought they would not continue to submit to their respective journal if it became open access and charged, largely because of the reputaiton of the journals. Half (54%, 255/468) said open access has ‘no impact’ or was ‘low priority’ in their submission decisions. Two-thirds (66%, 308/468) said they would prefer to submit to a non-open access subscription-based journal than an open access author-pays journal. Over half thought they would have to make a contribution or pay the full cost of an author charge (56%, 262/468). Conclusions The survey yielded useful information about respondents’ knowledge and perceptions of these publishing models. Authors have limited familiarity with the concept of open-access publishing and surrounding issues. Currently, open access policies have little impact on authors’ decision of where to submit papers.
A Systematic Review of Systematic Reviews of Spinal Manipulation
Authors: Ernst E , Canter P H 
Published: November 2017

Objectives To systematically collate and evaluate the evidence from recent systematic reviews of clinical trials of spinal manipulation. Design Literature searches were carried out in four electronic databases for all systematic reviews of the effectiveness of spinal manipulation in any indication, published between 2000 and May 2005. Reviews were defined as systematic if they included an explicit and repeatable inclusion and exclusion criteria for studies. Results Sixteen papers were included relating to the following conditions: back pain (n=3), neck pain (n=2), lower back pain and neck pain (n=1), headache (n=3), non-spinal pain (n=1), primary and secondary dysmenorrhoea (n=1), infantile colic (n=1), asthma (n=1), allergy (n=1), cervicogenic dizziness (n=1), and any medical problem (n=1). The conclusions of these reviews were largely negative, except for back pain where spinal manipulation was considered superior to sham manipulation but not better than conventional treatments. Conclusions Collectively these data do not demonstrate that spinal manipulation is an effective intervention for any condition. Given the possibility of adverse effects, this review does not suggest that spinal manipulation is a recommendable treatment.
Trends in National and State-Level Obesity in the USA after Correction for Self-Report Bias: Analysis of Health Surveys
Authors: Ezzati Majid , Martin Hilarie , Skjold Suzanne , Hoorn Stephen Vander , Murray Christopher J L 
Published: November 2017

Objectives To quantify population-level bias in self-reported weight and height as a function of age, sex, and the mode of self-report, and to estimate unbiased trends in national and state level obesity in the USA. Design Statistical analysis of repeated cross-sectional health examination surveys (the National Health and Nutrition Examination Survey [NHANES]) and health surveys (the Behavioral Risk Factor Surveillance System [BRFSS]) in the USA. Setting The 50 states of the USA and the District of Columbia. Results In the USA, on average, women underreported their weight, but men did not. Young and middle-aged (565 years) adult men over-reported their height more than women of the same age. In older age groups, over-reporting of height was similar in men and women. Population-level bias in self-reported weight was larger in telephone interviews (BRFSS) than in-person interviews (NHANES). Except in older adults, height was over-reported more often in telephone interviews than in-person interviews. Using corrected weight and height in the year 2000, Mississippi (31%) and Texas (30%) had the highest prevalence of obesity for men; Texas (37%), Louisiana (37%), Mississippi (37%), District of Columbia (37%), Alabama (37%), and South Carolina (36%) for women. Conclusions Population-level bias in self-reported weight and height is larger in telephone interviews than in-person interviews. Telephone interviews are a low-cost method for regular, nationally- and sub-nationally representative monitoring of obesity. It is possible to obtain corrected estimates of trends and geographical distributions of obesity from telephone interviews by using systematic analysis which measure weight and height from an independent sample of the same population.
Learning from Death: A Hospital Mortality Reduction Programme
Authors: Wright John , Dugdale Bob , Hammond Ian , Jarman Brian , Neary Maria , Newton Duncan , Patterson Chris , Russon Lynne , Stanley Philip , Stephens Rose , Warren Erica 
Published: November 2017

Problem There are wide variations in hospital mortality. Much of this variation remains unexplained and may reflect quality of care. Setting A large acute hospital in an urban district in the North of England. Design Before and after evaluation of a hospital mortality reduction programme. Strategies for change Audit of hospital deaths to inform an evidence-based approach to identify processes of care to target for the hospital strategy. Establishment of a hospital mortality reduction group with senior leadership and support to ensure the alignment of the hospital departments to achieve a common goal. Robust measurement and regular feedback of hospital deaths using statistical process control charts and summaries of death certificates and routine hospital data. Whole system working across a health community to provide appropriate end of life care. Training and awareness in processes of high quality care such as clinical observation, medication safety and infection control. Effects Hospital standardized mortality ratios fell significantly in the 3 years following the start of the programme from 94.6 (95% confidence interval 89.4, 99.9) in 2001 to 77.5 (95% CI 73.1, 82.1) in 2005. This translates as 905 fewer hospital deaths than expected during the period 2002–2005. Lessons learnt Improving the safety of hospital care and reducing hospital deaths provides a clear and well supported goal from clinicians, managers and patients. Good leadership, good information, a quality improvement strategy based on good local evidence and a community-wide approach may be effective in improving the quality of processes of care sufficiently to reduce hospital mortality.
Doctors Charged with Manslaughter in the Course of Medical Practice, 1795–2005: A Literature Review
Authors: Ferner R E , McDowell Sarah E 
Published: November 2017

Objectives To quantify the number of doctors charged with manslaughter in the course of legitimate medical practice and to classify cases, as mistakes, slips (or lapses), and violations, using a recognized classification of human error system. Design We searched newspaper databases, Medline, Embase, and the Wellcome library catalogue to identify relevant cases from 1795 to December 2005. Setting Medical practice in the United Kingdom. Main Outcome Measure Number of doctors charged with manslaughter in the course of medical practice. Results We identified 85 doctors charged with manslaughter since 1795. The number of doctors charged was relatively high in the mid-19th century and the inter-war years, and has dramatically increased since 1990. Sixty of the doctors were acquitted, 22 were convicted, and three pleaded guilty. Most doctors were charged as a consequence of mistakes (37) or slips (17), and a minority because of alleged violations (16). Conclusions The number of doctors prosecuted for manslaughter has risen steeply since 1990, but the proportion of doctors convicted remains low. Prosecution for deliberately violating rules is understandable, but accounts for only a minority of these cases. Unconscious errors–-mistakes and slips (or lapses)–-are an inescapable consequence of human actions and prosecution of individuals is unlikely to improve patient safety. That requires improvement to the complex systems of health care.
Exercise-Associated Hyponatraemia after a Marathon: Case Series
Authors: Goudie A M , Tunstall-Pedoe D S , Kerins M , Terris J 
Published: November 2017

Objectives To review the presentation, treatment and response of those runners from the London Marathon who presented to St Thomas’ Hospital with exercise induced hyponatraemia. Design Observational case series. Setting St Thomas’ Hospital, a tertiary hospital situated near the finish line of the 2003 London Marathon. Participants All runners who presented to St Thomas’ Hospital on the day of the 2003 London Marathon with altered mental state whose serum sodium concentration was less than 135 mmol/L. Main outcome measures Presenting symptoms, volume and type of fluids administered and response to treatment (biochemical and clinical). Results Fourteen patients were diagnosed with exercise associated hyponatraemia with serum sodium concentrations ranging from 116 to 133 mmol/L. Eleven presented with confusion. There were long delays between the finish time and presentation time for some runners. Anecdotal descriptions suggested some runners finished the race with normal mental state then became confused. There was no correlation between running time and serum sodium level. All patients received 0.9% saline and six received 1.8% saline. Despite this, some patients demonstrated falls in serum sodium concentrations. Thirteen to fourteen patients were symptomatically well the following morning, with the remaining patient significantly improved. Conclusion Presentation of exercise associated hyponatraemia may be delayed. Optimal treatment is controversial, but the use of isotonic saline may not result in rises of serum sodium and we would suggest the early use of hypertonic fluids in symptomatic patients.
Walking, Cycling and Transport Safety: An Analysis of Child Road Deaths
Authors: Sonkin Beth , Edwards Phil , Roberts Ian , Green Judith 
Published: November 2017

Objective To examine trends in road death rates for child pedestrians, cyclists and car occupants. Design Analysis of road traffic injury death rates per 100 000 children and death rates per 10 million passenger miles travelled. Setting England and Wales between 1985 and 2003. Participants Children aged 0–14 years. Interventions None. Main outcome measures Death rates per 100 000 children and per 10 million child passenger miles for pedestrians, cyclists and car occupants. Results Death rates per head of population have declined for child pedestrians, cyclists and car occupants but pedestrian death rates remain higher (0.55 deaths/100 000 children; 95% confidence interval [CI] 0.42 to 0.72 deaths) than those for car occupants (0.34 deaths; 95% CI 0.23 to 0.48 deaths) and cyclists (0.16 deaths; 95% CI 0.09 to 0.27 deaths). Since 1985, the average distance children travelled as a car occupant has increased by 70%; the average distance walked has declined by 19%; and the average distance cycled has declined by 58%. Taking into account distance travelled, there are about 50 times more child cyclist deaths (0.55 deaths/10 million passenger miles; 0.32 to 0.89) and nearly 30 times more child pedestrian deaths (0.27 deaths; 0.20 to 0.35) than there are deaths to child car occupants (0.01 deaths; 0.007 to 0.014). In 2003, children from families without access to a vehicle walked twice the distance walked by children in families with access to two or more vehicles. Conclusions More needs to be done to reduce the traffic injury death rates for child pedestrians and cyclists. This might encourage more walking and cycling and also has the potential to reduce social class gradients in injury mortality.
Identifying Patients at High Risk of Emergency Hospital Admissions: A Logistic Regression Analysis
Authors: Bottle Alex , Aylin Paul , Majeed Azeem 
Published: November 2017

Objective To use routine data to identify patients at high risk of future emergency hospital admissions. Design Descriptive analysis of inpatient hospital episode statistics. Predictive model developed using multiple logistic regression. Setting National Health Service hospital trusts in England. Participants All patients with an emergency admission to an NHS hospital between 1 April 2000 and 31 March 2001. Main outcome measures ‘High-impact users’ were defined as patients who had at least one emergency inpatient admission and who then went on to have at least two further emergency hospital admissions in the 12 months following the start date of that index admission. Results 2 895 234 patients were admitted as emergencies in 2000/2001, of whom 147 725 (5.1%) did not survive their first spell. Of the 2 747 509 surviving patients, 269 686 (9.8%) subsequently had at least two or more emergency admissions within 365 days of the index date of admission. A further 236 779 (8.6%) died during this period. Risk factors for becoming a high-impact user included the number of emergencies in the 36 months before index spell, comorbidity, age, an admission for an ambulatory care sensitive condition, ethnicity, area-level socio-economic data, local admission rates, the number of episodes in the index spell, sex and the source of admission. The predictive model based on all emergency admissions produced a receiver operating characteristic curve score of 0.72. Conclusions Routine hospital episode statistics can be used to identify patients who are at high risk of suffering future multiple emergency hospital admissions. The potential cost savings in preventing a proportion of these subsequent admissions need to be compared with the costs of case management of these patients.
Diabetes management in the USA and England: comparative analysis of national surveys
Authors: Mainous Arch G , Diaz Vanessa A , Saxena Sonia , Baker Richard , Everett Charles J , Koopman Richelle J , Majeed Azeem 
Published: November 2017

Objectives To compare diabetes management in adults between England and the United States, particularly focusing on the impact of a universal access health insurance system. Design Analysis of the nationally-representative surveys Health Survey of England, 2003 (unweighted n=14 057) and the National Health and Nutrition Examination Survey, 2001–2002 (unweighted n=5411). Setting and Participants Adults 20–64 years of age; individuals >65. Main Outcome Measures Glycaemic, lipid and blood pressure control and medication use among individuals with previously diagnosed diabetes. Results Among those aged 20–64 the prevalence of diagnosed diabetes was lower in England (2.7%) than in the USA (5.0%). The proportion with diabetes receiving treatment was similar for the two countries. However, the mean HbA1c in England was 7.6%: in the USA it was 7.5% for those with insurance and 8.6% for those without insurance. The proportion of individuals on ACE inhibitors in England was 39%: in USA it was 39% for those with insurance, and 14% for those without. Conclusions Individuals in a healthcare system providing universal access have better managed diabetes than those in a market based system once one accounts for insurance.