Publications

@article{lshtm269b,

title = {Consent in emergency care research ? Authors' reply},

author = {Ian Roberts and Iain Chalmers and Haleema Shakur-Still and David Prieto-Merino and Jon Nicholl},

url = {http://researchonline.lshtm.ac.uk/id/eprint/269/},

year  = {2011},

date = {2011-01-01},

journal = {Lancet},

volume = {378},

number = {9785},

pages = {27--27},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm20569,

title = {Tranexamic acid for postpartum bleeding.},

author = {Ian Roberts and Katharine Ker},

url = {http://researchonline.lshtm.ac.uk/id/eprint/20569/},

year  = {2011},

date = {2011-01-01},

journal = {International journal of gynaecology and obstetrics},

volume = {115},

number = {3},

pages = {220--221},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm270,

title = {Early administration of tranexamic acid in trauma patients ? Authors' reply},

author = {Ian Roberts and David Prieto-Merino and Pablo Perel and Haleema Shakur-Still},

url = {http://researchonline.lshtm.ac.uk/id/eprint/270/},

year  = {2011},

date = {2011-01-01},

journal = {Lancet},

volume = {378},

number = {9785},

pages = {28--28},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm1045,

title = {Effect of consent rituals on mortality in emergency care research.},

author = {Ian Roberts and David Prieto-Merino and Haleema Shakur-Still and Iain Chalmers and Jon Nicholl},

url = {http://researchonline.lshtm.ac.uk/id/eprint/1045/},

year  = {2011},

date = {2011-01-01},

journal = {Lancet},

volume = {377},

number = {9771},

pages = {1071--1072},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm19123,

title = {The added value of ordinal analysis in clinical trials: an example in traumatic brain injury.},

author = {Bob Roozenbeek and Hester F Lingsma and Pablo Perel and Phil Edwards and Ian Roberts and Gordon D Murray and Andrew Ir Maas and Ewout W Steyerberg and IMPACT (International Mission on Prognosis and Clinical Trial) and CRASH (Corticosteroid Randomisation After Significant Head Injury)},

url = {http://researchonline.lshtm.ac.uk/id/eprint/19123/},

year  = {2011},

date = {2011-01-01},

journal = {Critical care (London, England)},

volume = {15},

number = {3},

pages = {R127--},

publisher = {BMC},

abstract = {INTRODUCTION: In clinical trials, ordinal outcome measures are often dichotomized into two categories. In traumatic brain injury (TBI) the 5-point Glasgow outcome scale (GOS) is collapsed into unfavourable versus favourable outcome. Simulation studies have shown that exploiting the ordinal nature of the GOS increases chances of detecting treatment effects. The objective of this study is to quantify the benefits of ordinal analysis in the real-life situation of a large TBI trial. METHODS: We used data from the CRASH trial that investigated the efficacy of corticosteroids in TBI patients (n = 9,554). We applied two techniques for ordinal analysis: proportional odds analysis and the sliding dichotomy approach, where the GOS is dichotomized at different cut-offs according to baseline prognostic risk. These approaches were compared to dichotomous analysis. The information density in each analysis was indicated by a Wald statistic. All analyses were adjusted for baseline characteristics. RESULTS: Dichotomous analysis of the six-month GOS showed a non-significant treatment effect (OR = 1.09, 95% CI 0.98 to 1.21, P = 0.096). Ordinal analysis with proportional odds regression or sliding dichotomy showed highly statistically significant treatment effects (OR 1.15, 95% CI 1.06 to 1.25, P = 0.0007 and 1.19, 95% CI 1.08 to 1.30, P = 0.0002), with 2.05-fold and 2.56-fold higher information density compared to the dichotomous approach respectively. CONCLUSIONS: Analysis of the CRASH trial data confirmed that ordinal analysis of outcome substantially increases statistical power. We expect these results to hold for other fields of critical care medicine that use ordinal outcome measures and recommend that future trials adopt ordinal analyses. This will permit detection of smaller treatment effects.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm1258,

title = {Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials.},

author = {Saleena Subaiya and Euan Hogg and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/1258/},

year  = {2011},

date = {2011-01-01},

journal = {Trials},

volume = {12},

number = {1},

pages = {31--},

publisher = {BMC},

abstract = {BACKGROUND: All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made. METHODS: We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials), quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared. RESULTS: The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions), whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions). CONCLUSIONS: Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1. TRIAL REGISTRATION NUMBERS: CRASH-1: ISRCTN74459797CRASH-2: ISRCTN86750102.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm985,

title = {Non-vigorous physical activity and all-cause mortality: systematic review and meta-analysis of cohort studies.},

author = {James Woodcock and Oscar H Franco and Nicola Orsini and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/985/},

year  = {2011},

date = {2011-01-01},

journal = {International journal of epidemiology},

volume = {40},

number = {1},

pages = {121--138},

publisher = {Oxford University Press (OUP)},

abstract = {BACKGROUND: Although previous studies have found physical activity to be associated with lower mortality, the dose-response relationship remains unclear. In this systematic review and meta-analysis we quantify the dose-response relationship of non-vigorous physical activity and all-cause mortality. METHODS: We aimed to include all cohort studies in adult populations with a sample size of more than 10 000 participants that estimated the effect of different levels of light or moderate physical activity on all-cause mortality. We searched Medline, Embase, Cochrane (DARE), Web of Science and Global Health (June 2009). We used dose-response meta-regression models to estimate the relation between non-vigorous physical activity and mortality. RESULTS: We identified 22 studies that met our inclusion criteria, containing 977 925 (334 738 men and 643 187 women) people. There was considerable variation between the studies in their categorization of physical activity and adjustment for potential confounders. We found that 2.5 h/week (equivalent to 30 min daily of moderate intensity activity on 5 days a week) compared with no activity was associated with a reduction in mortality risk of 19% [95% confidence interval (CI) 15-24], while 7 h/week of moderate activity compared with no activity reduced the mortality risk by 24% (95% CI 19-29). We found a smaller effect in studies that looked at walking alone. CONCLUSION: Being physically active reduces the risk of all-cause mortality. The largest benefit was found from moving from no activity to low levels of activity, but even at high levels of activity benefits accrue from additional activity.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm1302,

title = {European society of intensive care medicine study of therapeutic hypothermia (32-35 °C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial).},

author = {Peter JD Andrews and Helen Louise Sinclair and Claire G Battison and Kees H Polderman and Giuseppe Citerio and Luciana Mascia and Bridget A Harris and Gordon D Murray and Nino Stocchetti and David K Menon and Haleema Shakur-Still and Daniel De Backer and Eurotherm3235Trial collaborators},

url = {http://researchonline.lshtm.ac.uk/id/eprint/1302/},

year  = {2011},

date = {2011-01-01},

journal = {Trials},

volume = {12},

number = {1},

pages = {8--},

publisher = {BMC},

abstract = {BACKGROUND: Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union.Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1 °C/4 hours). Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided. METHODS/DESIGN: This is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35 °C, titrated to reduce intracranial pressure <20 mmHg, on morbidity and mortality 6 months after traumatic brain injury. The study aims to recruit 1800 patients over 41 months. Enrolment started in April 2010.Participants are randomised to either standard care or standard care with titrated therapeutic hypothermia. Hypothermia is initiated with 20-30 ml/kg of intravenous, refrigerated 0.9% saline and maintained using each centre's usual cooling technique. There is a guideline for detection and treatment of shivering in the intervention group. Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure <20 mmHg. Intracranial hypertension is defined as an intracranial pressure >20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007. DISCUSSION: The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It represents a new and fundamental step for intensive care medicine in Europe. Recruitment will continue until January 2013 and interested clinicians from intensive care units worldwide can still join this important collaboration by contacting the Trial Coordinating Team via the trial website http://www.eurotherm3235trial.eu. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34555414.



},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm56817,

title = {Using a business model approach and marketing techniques for recruitment to clinical trials.},

author = {Alison M McDonald and Shaun Treweek and Haleema Shakur-Still and Caroline Free and Rosemary Knight and Chris Speed and Marion K Campbell},

url = {http://researchonline.lshtm.ac.uk/id/eprint/56817/},

year  = {2011},

date = {2011-01-01},

journal = {Trials},

volume = {12},

number = {1},

pages = {74--},

publisher = {BMC},

abstract = {Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm785,

title = {Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review.},

author = {Thoai D Ngo and Min Hae Park and Haleema Shakur-Still and Caroline Free},

url = {http://researchonline.lshtm.ac.uk/id/eprint/785/},

year  = {2011},

date = {2011-01-01},

journal = {Bulletin of the World Health Organization},

volume = {89},

number = {5},

pages = {360--370},

publisher = {World Health Organization (WHO)},

abstract = {OBJECTIVE: To compare medical abortion practised at home and in clinics in terms of effectiveness, safety and acceptability. METHODS: A systematic search for randomized controlled trials and prospective cohort studies comparing home-based and clinic-based medical abortion was conducted. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE and Popline were searched. Failure to abort completely, side-effects and acceptability were the main outcomes of interest. Odds ratios and their 95% confidence intervals (CIs) were calculated. Estimates were pooled using a random-effects model. FINDINGS: Nine studies met the inclusion criteria (n = 4522 participants). All were prospective cohort studies that used mifepristone and misoprostol to induce abortion. Complete abortion was achieved by 86-97% of the women who underwent home-based abortion (n = 3478) and by 80-99% of those who underwent clinic-based abortion (n = 1044). Pooled analyses from all studies revealed no difference in complete abortion rates between groups (odds ratio = 0.8; 95% CI: 0.5-1.5). Serious complications from abortion were rare. Pain and vomiting lasted 0.3 days longer among women who took misoprostol at home rather than in clinic. Women who chose home-based medical abortion were more likely to be satisfied, to choose the method again and to recommend it to a friend than women who opted for medical abortion in a clinic. CONCLUSION: Home-based abortion is safe under the conditions in place in the included studies. Prospective cohort studies have shown no differences in effectiveness or acceptability between home-based and clinic-based medical abortion across countries.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm1687,

title = {Antifibrinolytic drugs for acute traumatic injury.},

author = {I Roberts and Haleema Shakur-Still and K Ker and T Coats and CRASH-2 Trial collaborators},

url = {http://researchonline.lshtm.ac.uk/id/eprint/1687/},

year  = {2011},

date = {2011-01-01},

journal = {The Cochrane database of systematic reviews},

volume = {1},

number = {1},

pages = {CD004896},

publisher = {Cochrane Collaboration},

abstract = {: Uncontrolled bleeding is an important cause of death in trauma victims. Antifibrinolytic treatment has been shown to reduce blood loss following surgery and may also be effective in reducing blood loss following trauma.ensuremath
 : To quantify the effect of antifibrinolytic drugs in reducing blood loss, transfusion requirement and mortality after acute traumatic injury.ensuremath
 : We searched the Cochrane Injuries Group's Specialised Register, CENTRAL, MEDLINE, PubMed, EMBASE, Science Citation Index, National Research Register, Zetoc, SIGLE, Global Health, LILACS, and Current Controlled Trials. The Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE and EMBASE searches were updated in July 2010.ensuremath
 : We included all randomised controlled trials of antifibrinolytic agents (aprotinin, tranexamic acid [TXA] and epsilon-aminocaproic acid) following acute traumatic injury.ensuremath
 : The titles and abstracts identified in the electronic searches were screened by two independent authors to identify studies that had the potential to meet the inclusion criteria. The full reports of all such studies were obtained. From the results of the screened electronic searches, bibliographic searches, and contacts with experts, two authors independently selected trials meeting the inclusion criteria, with any disagreements resolved by consensus.ensuremath
 : Four trials met the inclusion criteria. Two trials with a combined total of 20,451 patients assessed the effects of TXA on mortality; TXA reduced the risk of death by 10% (RR=0.90, 95% CI 0.85 to 0.97; p=0.0035). Data from one trial involving 20,211 patients found that TXA reduced the risk of death due to bleeding by 15% (RR=0.85, 95% CI 0.76 to 0.96; p=0.0077). There was no evidence that TXA increased the risk of vascular occlusive events or need for surgical intervention. There was no substantial difference in the receipt of blood transfusion between the TXA and placebo groups. The two trials of aprotinin provided no reliable data.ensuremath
 : TXA safely reduces mortality in bleeding trauma patients without increasing the risk of adverse events. Further trials are needed to determine the effects of TXA in patients with isolated traumatic brain injury.ensuremath
},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm1035,

title = {The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial.},

author = {CRASH-2 collaborators and Ian Roberts and Haleema Shakur-Still and Adefemi Afolabi and Karim Brohi and Tim Coats and Yashbir Dewan and Satoshi Gando and Gordon Guyatt and BJ Hunt and Carlos Morales and Pablo Perel and David Prieto-Merino and Tom Woolley},

url = {http://researchonline.lshtm.ac.uk/id/eprint/1035/},

year  = {2011},

date = {2011-01-01},

journal = {Lancet},

volume = {377},

number = {9771},

pages = {1096--1101.e2},

publisher = {Elsevier},

abstract = {BACKGROUND: The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. METHODS: The CRASH-2 trial was undertaken in 274 hospitals in 40 countries. 20,211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health DOH-27-0607-1919. FINDINGS: 10,096 patients were allocated to tranexamic acid and 10,115 to placebo, of whom 10,060 and 10,067, respectively, were analysed. 1063 deaths (35%) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction pensuremath<0.0001). Early treatment ($łeq$1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5.3%] events in tranexamic acid group vs 286/3704 [7.7%] in placebo group; relative risk [RR] 0.68, 95% CI 0.57-0.82; pensuremath<0.0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4.8%] vs 184/2996 [6.1%]; RR 0.79, 0.64-0.97; p=0.03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4.4%] vs 103/3362 [3.1%]; RR 1.44, 1.12-1.84; p=0.004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. INTERPRETATION: Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. FUNDING: UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2216,

title = {Doctors and climate change.},

author = {Ian Roberts and Robin Stott and Climate and Health Council executive},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2216/},

year  = {2010},

date = {2010-11-01},

journal = {BMJ (Clinical research ed)},

volume = {341},

number = {nov17},

pages = {c6357--},

publisher = {BMJ Publishing Group},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4651460,

title = {Complete genome sequence and comparative metabolic profiling of the prototypical enteroaggregative Escherichia coli strain 042.},

author = {Roy R Chaudhuri and Mohammed Sebaihia and Jon L Hobman and Mark A Webber and Denisse L Leyton and Martin D Goldberg and Adam F Cunningham and Anthony Scott-Tucker and Paul R Ferguson and Christopher M Thomas and Gad Frankel and Christoph M Tang and Edward G Dudley and Ian S Roberts and David A Rasko and Mark J Pallen and Julian Parkhill and James P Nataro and Nicholas R Thomson and Ian R Henderson},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4651460/},

year  = {2010},

date = {2010-01-01},

journal = {PLOS ONE},

volume = {5},

number = {1},

pages = {e8801--},

publisher = {PUBLIC LIBRARY SCIENCE},

abstract = {BACKGROUND: Escherichia coli can experience a multifaceted life, in some cases acting as a commensal while in other cases causing intestinal and/or extraintestinal disease. Several studies suggest enteroaggregative E. coli are the predominant cause of E. coli-mediated diarrhea in the developed world and are second only to Campylobacter sp. as a cause of bacterial-mediated diarrhea. Furthermore, enteroaggregative E. coli are a predominant cause of persistent diarrhea in the developing world where infection has been associated with malnourishment and growth retardation. METHODS: In this study we determined the complete genomic sequence of E. coli 042, the prototypical member of the enteroaggregative E. coli, which has been shown to cause disease in volunteer studies. We performed genomic and phylogenetic comparisons with other E. coli strains revealing previously uncharacterised virulence factors including a variety of secreted proteins and a capsular polysaccharide biosynthetic locus. In addition, by using Biolog Phenotype Microarrays we have provided a full metabolic profiling of E. coli 042 and the non-pathogenic lab strain E. coli K-12. We have highlighted the genetic basis for many of the metabolic differences between E. coli 042 and E. coli K-12. CONCLUSION: This study provides a genetic context for the vast amount of experimental and epidemiological data published thus far and provides a template for future diagnostic and intervention strategies.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm3305,

title = {Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.},

author = {CRASH-2 trial collaborators and Haleema Shakur-Still and Ian Roberts and Raúl Bautista and José Caballero and Tim Coats and Yashbir Dewan and Hesham El-Sayed and Tamar Gogichaishvili and Sanjay Gupta and Jorge Herrera and Beverley Hunt and Pius Iribhogbe and Mario Izurieta and Hussein Khamis and Edward Komolafe and María-Acelia Marrero and Jorge Mejía-Mantilla and Jaime Miranda and Carlos Morales and Oluwole Olaomi and Fatos Olldashi and Pablo Perel and Richard Peto and PV Ramana and RR Ravi and Surakrant Yutthakasemsunt},

url = {http://researchonline.lshtm.ac.uk/id/eprint/3305/},

year  = {2010},

date = {2010-01-01},

journal = {Lancet},

volume = {376},

number = {9734},

pages = {23--32},

publisher = {Elsevier},

abstract = {BACKGROUND: Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. METHODS: This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.govNCT00375258, and South African Clinical Trial RegisterDOH-27-0607-1919. FINDINGS: 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14.5%] tranexamic acid group vs 1613 [16.0%] placebo group; relative risk 0.91, 95% CI 0.85-0.97; p=0.0035). The risk of death due to bleeding was significantly reduced (489 [4.9%] vs 574 [5.7%]; relative risk 0.85, 95% CI 0.76-0.96; p=0.0077). INTERPRETATION: Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. FUNDING: UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2659,

title = {Post-partum haemorrhage and the WOMAN trial.},

author = {Lisa Cook and Ian Roberts and WOMAN Trial Collaborators},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2659/},

year  = {2010},

date = {2010-01-01},

journal = {International journal of epidemiology},

volume = {39},

number = {4},

pages = {949--950},

publisher = {Oxford University Press (OUP)},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4018,

title = {Giving tranexamic acid to reduce surgical bleeding in sub-Saharan Africa: an economic evaluation.},

author = {Carla Guerriero and John Cairns and Sudha Jayaraman and Ian Roberts and Pablo Perel and Haleema Shakur-Still},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4018/},

year  = {2010},

date = {2010-01-01},

journal = {Cost effectiveness and resource allocation},

volume = {8},

number = {1},

pages = {1--},

publisher = {BMC},

abstract = {BACKGROUND: The identification of safe and effective alternatives to blood transfusion is a public health priority. In sub-Saharan Africa, blood shortage is a cause of mortality and morbidity. Blood transfusion can also transmit viral infections. Giving tranexamic acid (TXA) to bleeding surgical patients has been shown to reduce both the number of blood transfusions and the volume of blood transfused. The objective of this study is to investigate whether routinely administering TXA to bleeding elective surgical patients is cost effective by both averting deaths occurring from the shortage of blood, and by preventing infections from blood transfusions. METHODS: A decision tree was constructed to evaluate the cost-effectiveness of providing TXA compared with no TXA in patients with surgical bleeding in four African countries with different human immunodeficiency virus (HIV) prevalence and blood donation rates (Kenya, South Africa, Tanzania and Botswana). The principal outcome measures were cost per life saved and cost per infection averted (HIV, Hepatitis B, Hepatitis C) averted in 2007 International dollars ($). The probability of receiving a blood transfusion with and without TXA and the risk of blood borne viral infection were estimated. The impact of uncertainty in model parameters was explored using one-way deterministic sensitivity analyses. Probabilistic sensitivity analysis was performed using Monte Carlo simulation. RESULTS: The incremental cost per life saved is $87 for Kenya and $93 for Tanzania. In Botswana and South Africa, TXA administration is not life saving but is highly cost saving since fewer units of blood are transfused. Further, in Botswana the administration of TXA averts one case of HIV and four cases of Hepatitis B (HBV) per 1,000 surgical patients. In South Africa, one case of HBV is averted per 1,000 surgical patients. Probabilistic sensitivity analyses confirmed the robustness of the model. CONCLUSION: An economic argument can be made for giving TXA to bleeding elective surgical patients. In countries where there is a blood shortage, TXA would be a cost effective way to reduce mortality. In countries where there is no blood shortage, TXA would reduce healthcare costs and avert blood borne infections.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2484,

title = {Managing clinical trials.},

author = {Barbara Farrell and Sara Kenyon and Haleema Shakur-Still},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2484/},

year  = {2010},

date = {2010-01-01},

journal = {Trials},

volume = {11},

number = {1},

pages = {78--},

publisher = {BMC},

abstract = {Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm3741,

title = {Caffeine for the prevention of injuries and errors in shift workers.},

author = {Katharine Ker and Philip James Edwards and Lambert M Felix and Karen Blackhall and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/3741/},

year  = {2010},

date = {2010-01-01},

journal = {The Cochrane database of systematic reviews},

volume = {5},

number = {5},

pages = {CD008508--},

publisher = {Cochrane Collaboration},

abstract = {BACKGROUND: Sleepiness leads to a deterioration in performance and attention, and is associated with an increased risk of injury. Jet lag and shift work disorder are circadian rhythm sleep disorders which result in sleepiness and can elevate injury risk. They create a need for individuals to operate at times which are different to those dictated by their circadian rhythms. Consequently there is also a need for interventions to help ensure that these persons can do so safely. Caffeine has a potential role in promoting alertness during times of desired wakefulness in persons with jet lag or shift work disorder, however its effects on injury and error are unclear. OBJECTIVES: To assess the effects of caffeine for preventing injuries caused by impaired alertness in persons with jet lag or shift work disorder. SEARCH STRATEGY: We searched the Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE, EMBASE, PsycINFO, CINAHL, TRANSPORT (to July 2008); and PubMed databases (to April 2010). We also searched the Internet and checked reference lists of relevant papers. SELECTION CRITERIA: Randomised controlled trials investigating the effects of caffeine on injury, error or cognitive performance in people with jet lag or shift work disorder. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results and assessed full texts for inclusion. Data were extracted and risk of bias was assessed. Estimates of treatment effect (odds ratio and standardised mean difference (SMD)) and 95% confidence intervals (CI) were calculated and pooled using the fixed-effect model. MAIN RESULTS: Thirteen trials were included. None measured an injury outcome. Two trials measured error, and the remaining trials used neuropsychological tests to assess cognitive performance. The trials assessing the impact on errors found that caffeine significantly reduced the number of errors compared to placebo. The pooled effect estimates on performance by cognitive domain suggest that, when compared to placebo, caffeine improved concept formation and reasoning (SMD -0.41; 95% CI -1.04 to 0.23), memory (SMD -1.08; 95% CI -2.07 to -0.09), orientation and attention (SMD -0.55; 95% CI -0.83 to -0.27) and perception (SMD -0.77; 95% CI -1.73 to 0.20); although there was no beneficial effect on verbal functioning and language skills (SMD 0.18; 95% CI -0.50 to 0.87). One trial comparing the effects of caffeine with a nap found that there were significantly less errors made in the caffeine group. Other trials comparing caffeine with other active interventions (for example nap, bright light, modafinil) found no significant differences. There is a high risk of bias for the adequacy of allocation concealment and presence of selective outcome reporting amongst the trials. AUTHORS' CONCLUSIONS: Caffeine may be an effective intervention for improving performance in shift workers however, there are no trials from which we can assess its effect on injuries. The results largely originate from studies involving young participants under simulated conditions, and the extent to which the findings are generalisable to older workers and real world shift work is unclear. Based on the current evidence, there is no reason for healthy individuals who already use caffeine within recommended levels to improve their alertness to stop doing so. The assessment of the relative effects of caffeine to other potential countermeasures should be a focus of future research.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4238,

title = {Haemostatic drugs for traumatic brain injury.},

author = {Pablo Perel and Ian Roberts and Haleema Shakur-Still and Bandit Thinkhamrop and Nakornchai Phuenpathom and Surakrant Yutthakasemsunt},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4238/},

year  = {2010},

date = {2010-01-01},

journal = {The Cochrane database of systematic reviews},

volume = {1},

number = {1},

pages = {CD007877--},

publisher = {Cochrane Collaboration},

abstract = {BACKGROUND: Traumatic brain injury (TBI) is a leading cause of death and disability. Intracranial bleeding is a common complication of TBI, and intracranial bleeding can develop or worsen after hospital admission. Haemostatic drugs may reduce the occurrence or size of intracranial bleeds and consequently lower the morbidity and mortality associated with TBI. OBJECTIVES: To assess the effects of haemostatic drugs on mortality, disability and thrombotic complications in patients with traumatic brain injury. SEARCH STRATEGY: We searched the electronic databases: Cochrane Injuries Group Specialised Register (3 February 2009), CENTRAL (The Cochrane Library 2009, Issue 1), MEDLINE (1950 to Week 3 2009), PubMed (searched 3 February 2009 (last 180 days)), EMBASE (1980 to Week 4 2009), CINAHL (1982 to January 2009), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) (1970 to January 2009), ISI Web of Science: Conference Proceedings Citation Index - Science (CPCI-S) (1990 to January 2009). SELECTION CRITERIA: We included published and unpublished randomised controlled trials comparing haemostatic drugs (antifibrinolytics: aprotinin, tranexamic acid (TXA), aminocaproic acid or recombined activated factor VIIa (rFVIIa)) with placebo, no treatment, or other treatment in patients with acute traumatic brain injury. DATA COLLECTION AND ANALYSIS: Two review authors independently examined all electronic records, and extracted the data. We judged that there was clinical heterogeneity between trials so we did not attempt to pool the results of the included trials. The results are reported separately. MAIN RESULTS: We included two trials. One was a post-hoc analysis of 30 TBI patients from a randomised controlled trial of rFVIIa in blunt trauma patients. The risk ratio for mortality at 30 days was 0.64 (95% CI 0.25 to 1.63) for rFVIIa compared to placebo. This result should be considered with caution as the subgroup analysis was not pre-specified for the trial. The other trial evaluated the effect of rFVIIa in 97 TBI patients with evidence of intracerebral bleeding in a computed tomography (CT) scan. The corresponding risk ratio for mortality at the last follow up was 1.08 (95% CI 0.44 to 2.68). The quality of the reporting of both trials was poor so it was difficult to assess the risk of bias. AUTHORS' CONCLUSIONS: There is no reliable evidence from randomised controlled trials to support the effectiveness of haemostatic drugs in reducing mortality or disability in patients with TBI. New randomised controlled trials assessing the effects of haemostatic drugs in TBI patients should be conducted. These trials should be large enough to detect clinically plausible treatment effects.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2480,

title = {No miracle cure},

author = {I Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2480/},

year  = {2010},

date = {2010-01-01},

journal = {New scientist (1971)},

volume = {207},

number = {2779},

pages = {28--29},

publisher = {Ipc Magazines Ltd},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2040,

title = {Doctors and climate change.},

author = {Ian Roberts and Robin Stott},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2040/},

year  = {2010},

date = {2010-01-01},

journal = {Lancet},

volume = {376},

number = {9755},

pages = {1801--1802},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2479,

title = {Tranexamic acid for trauma Reply},

author = {Haleema Shakur-Still and I Roberts and P Perel},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2479/},

year  = {2010},

date = {2010-01-01},

journal = {Lancet},

volume = {376},

number = {9746},

pages = {1050--1051},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm3834,

title = {The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial.},

author = {Haleema Shakur-Still and Diana Elbourne and Metin Gülmezoglu and Zarko Alfirevic and Carine Ronsmans and Elizabeth Allen and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/3834/},

year  = {2010},

date = {2010-01-01},

journal = {Trials},

volume = {11},

number = {1},

pages = {40--},

publisher = {BMC},

abstract = {BACKGROUND: Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Of the deaths 99% are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mortality, most occurring in the postpartum period. Systemic antifibrinolytic agents are widely used in surgery to prevent clot breakdown (fibrinolysis) in order to reduce surgical blood loss. At present there is little reliable evidence from randomised trials on the effectiveness of tranexamic acid in the treatment of postpartum haemorrhage. METHODS: The Trial aims to determine the effect of early administration of tranexamic acid on mortality, hysterectomy and other morbidities (surgical interventions, blood transfusion, risk of non-fatal vascular events) in women with clinically diagnosed postpartum haemorrhage. The use of health services and safety, especially thromboembolic effect, on breastfed babies will also be assessed. The trial will be a large, pragmatic, randomised, double blind, placebo controlled trial among 15,000 women with a clinical diagnosis of postpartum haemorrhage. All legally adult women with clinically diagnosed postpartum haemorrhage following vaginal delivery of a baby or caesarean section will potentially be eligible. The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage. Treatment will entail a dose of tranexamic acid (1 gram by intravenous injection) or placebo (sodium chloride 0.9%) will be given as soon as possible after randomisation. A second dose may be given if after 30 minutes bleeding continues, or if it stops and restarts within 24 hours after the first dose. The main analyses will be on an 'intention to treat' basis, irrespective of whether the allocated treatment was received or not. Subgroup analyses for the primary outcome will be based on type of delivery; administration or not of prophylactic uterotonics; and on whether the clinical decision to consider trial entry was based primarily on estimated blood loss alone or on haemodynamic instability. A study with 15,000 women will have over 90% power to detect a 25% reduction from 4% to 3% in the primary endpoint of mortality or hysterectomy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm20487,

title = {Public health benefits of strategies to reduce greenhouse-gas emissions: overview and implications for policy makers.},

author = {Andy Haines and Anthony J McMichael and Kirk R Smith and Ian Roberts and James Woodcock and Anil Markandya and Ben G Armstrong and Diarmid Campbell-Lendrum and Alan D Dangour and Michael Davies and Nigel Bruce and Cathryn Tonne and Mark Barrett and Paul Wilkinson},

url = {http://researchonline.lshtm.ac.uk/id/eprint/20487/},

year  = {2009},

date = {2009-12-01},

journal = {Lancet},

volume = {374},

number = {9707},

pages = {2104--2114},

publisher = {Elsevier},

abstract = {This Series has examined the health implications of policies aimed at tackling climate change. Assessments of mitigation strategies in four domains-household energy, transport, food and agriculture, and electricity generation-suggest an important message: that actions to reduce greenhouse-gas emissions often, although not always, entail net benefits for health. In some cases, the potential benefits seem to be substantial. This evidence provides an additional and immediate rationale for reductions in greenhouse-gas emissions beyond that of climate change mitigation alone. Climate change is an increasing and evolving threat to the health of populations worldwide. At the same time, major public health burdens remain in many regions. Climate change therefore adds further urgency to the task of addressing international health priorities, such as the UN Millennium Development Goals. Recognition that mitigation strategies can have substantial benefits for both health and climate protection offers the possibility of policy choices that are potentially both more cost effective and socially attractive than are those that address these priorities independently.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4365,

title = {The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury.},

author = {Haleema Shakur-Still and Peter Andrews and Toomas Asser and Laura Balica and Cristian Boeriu and Juan Diego Ciro Quintero and Yashbir Dewan and Patrick Druwé and Olivia Fletcher and Chris Frost and Bennie Hartzenberg and Jorge Mejía-Mantilla and Francisco Murillo-Cabezas and Jan Pachl and Ramalingam R Ravi and Indrek R ä and Cristina Sampaio and Manmohan Singh and Petr Svoboda and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4365/},

year  = {2009},

date = {2009-12-01},

journal = {Trials},

volume = {10},

number = {1},

pages = {109--},

publisher = {BMC},

abstract = {BACKGROUND: Cerebral oedema is associated with significant neurological damage in patients with traumatic brain injury. Bradykinin is an inflammatory mediator that may contribute to cerebral oedema by increasing the permeability of the blood-brain barrier. We evaluated the safety and effectiveness of the non-peptide bradykinin B2 receptor antagonist Anatibant in the treatment of patients with traumatic brain injury. During the course of the trial, funding was withdrawn by the sponsor. METHODS: Adults with traumatic brain injury and a Glasgow Coma Scale score of 12 or less, who had a CT scan showing an intracranial abnormality consistent with trauma, and were within eight hours of their injury were randomly allocated to low, medium or high dose Anatibant or to placebo. Outcomes were Serious Adverse Events (SAE), mortality 15 days following injury and in-hospital morbidity assessed by the Glasgow Coma Scale (GCS), the Disability Rating Scale (DRS) and a modified version of the Oxford Handicap Scale (HIREOS). RESULTS: 228 patients out of a planned sample size of 400 patients were randomised. The risk of experiencing one or more SAEs was 26.4% (43/163) in the combined Anatibant treated group, compared to 19.3% (11/57) in the placebo group (relative risk = 1.37; 95% CI 0.76 to 2.46). All cause mortality in the Anatibant treated group was 19% and in the placebo group 15.8% (relative risk 1.20, 95% CI 0.61 to 2.36). The mean GCS at discharge was 12.48 in the Anatibant treated group and 13.0 in the placebo group. Mean DRS was 11.18 Anatibant versus 9.73 placebo, and mean HIREOS was 3.94 Anatibant versus 3.54 placebo. The differences between the mean levels for GCS, DRS and HIREOS in the Anatibant and placebo groups, when adjusted for baseline GCS, showed a non-significant trend for worse outcomes in all three measures. CONCLUSION: This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness. TRIAL REGISTRATION: This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN23625128.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm2064726,

title = {Author's response: time to forget about obesity.},

author = {Ian Roberts and Phil Edwards},

url = {http://researchonline.lshtm.ac.uk/id/eprint/2064726/},

year  = {2009},

date = {2009-08-01},

journal = {International journal of epidemiology},

volume = {41},

number = {6},

pages = {1849--},

publisher = {Oxford University Press (OUP)},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5119,

title = {Methods to increase response to postal and electronic questionnaires.},

author = {Philip James Edwards and Ian Roberts and Mike J Clarke and Carolyn Diguiseppi and Reinhard Wentz and Irene Kwan and Rachel Cooper and Lambert M Felix and Sarah Pratap},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5119/},

year  = {2009},

date = {2009-07-01},

journal = {The Cochrane database of systematic reviews},

volume = {3},

number = {3},

pages = {MR000008--},

publisher = {Cochrane Collaboration},

abstract = {BACKGROUND: Postal and electronic questionnaires are widely used for data collection in epidemiological studies but non-response reduces the effective sample size and can introduce bias. Finding ways to increase response to postal and electronic questionnaires would improve the quality of health research. OBJECTIVES: To identify effective strategies to increase response to postal and electronic questionnaires. SEARCH STRATEGY: We searched 14 electronic databases to February 2008 and manually searched the reference lists of relevant trials and reviews, and all issues of two journals. We contacted the authors of all trials or reviews to ask about unpublished trials. Where necessary, we also contacted authors to confirm methods of allocation used and to clarify results presented. We assessed the eligibility of each trial using pre-defined criteria. SELECTION CRITERIA: Randomised controlled trials of methods to increase response to postal or electronic questionnaires. DATA COLLECTION AND ANALYSIS: We extracted data on the trial participants, the intervention, the number randomised to intervention and comparison groups and allocation concealment. For each strategy, we estimated pooled odds ratios (OR) and 95% confidence intervals (CI) in a random-effects model. We assessed evidence for selection bias using Egger's weighted regression method and Begg's rank correlation test and funnel plot. We assessed heterogeneity among trial odds ratios using a Chi(2) test and the degree of inconsistency between trial results was quantified using the I(2) statistic. MAIN RESULTS: PostalWe found 481 eligible trials. The trials evaluated 110 different ways of increasing response to postal questionnaires. We found substantial heterogeneity among trial results in half of the strategies. The odds of response were at least doubled using monetary incentives (odds ratio 1.87; 95% CI 1.73 to 2.04; heterogeneity P < 0.00001, I(2) = 84%), recorded delivery (1.76; 95% CI 1.43 to 2.18; P = 0.0001, I(2) = 71%), a teaser on the envelope - e.g. a comment suggesting to participants that they may benefit if they open it (3.08; 95% CI 1.27 to 7.44) and a more interesting questionnaire topic (2.00; 95% CI 1.32 to 3.04; P = 0.06, I(2) = 80%). The odds of response were substantially higher with pre-notification (1.45; 95% CI 1.29 to 1.63; P < 0.00001, I(2) = 89%), follow-up contact (1.35; 95% CI 1.18 to 1.55; P < 0.00001, I(2) = 76%), unconditional incentives (1.61; 1.36 to 1.89; P < 0.00001, I(2) = 88%), shorter questionnaires (1.64; 95% CI 1.43 to 1.87; P < 0.00001, I(2) = 91%), providing a second copy of the questionnaire at follow up (1.46; 95% CI 1.13 to 1.90; P < 0.00001, I(2) = 82%), mentioning an obligation to respond (1.61; 95% CI 1.16 to 2.22; P = 0.98, I(2) = 0%) and university sponsorship (1.32; 95% CI 1.13 to 1.54; P < 0.00001, I(2) = 83%). The odds of response were also increased with non-monetary incentives (1.15; 95% CI 1.08 to 1.22; P < 0.00001, I(2) = 79%), personalised questionnaires (1.14; 95% CI 1.07 to 1.22; P < 0.00001, I(2) = 63%), use of hand-written addresses (1.25; 95% CI 1.08 to 1.45; P = 0.32, I(2) = 14%), use of stamped return envelopes as opposed to franked return envelopes (1.24; 95% CI 1.14 to 1.35; P < 0.00001, I(2) = 69%), an assurance of confidentiality (1.33; 95% CI 1.24 to 1.42) and first class outward mailing (1.11; 95% CI 1.02 to 1.21; P = 0.78, I(2) = 0%). The odds of response were reduced when the questionnaire included questions of a sensitive nature (0.94; 95% CI 0.88 to 1.00; P = 0.51, I(2) = 0%).ElectronicWe found 32 eligible trials. The trials evaluated 27 different ways of increasing response to electronic questionnaires. We found substantial heterogeneity among trial results in half of the strategies. The odds of response were increased by more than a half using non-monetary incentives (1.72; 95% CI 1.09 to 2.72; heterogeneity P < 0.00001, I(2) = 95%), shorter e-questionnaires (1.73; 1.40 to 2.13; P = 0.08, I(2) = 68%), including a statement that others had responded (1.52; 95% CI 1.36 to 1.70), and a more interesting topic (1.85; 95% CI 1.52 to 2.26). The odds of response increased by a third using a lottery with immediate notification of results (1.37; 95% CI 1.13 to 1.65), an offer of survey results (1.36; 95% CI 1.15 to 1.61), and using a white background (1.31; 95% CI 1.10 to 1.56). The odds of response were also increased with personalised e-questionnaires (1.24; 95% CI 1.17 to 1.32; P = 0.07, I(2) = 41%), using a simple header (1.23; 95% CI 1.03 to 1.48), using textual representation of response categories (1.19; 95% CI 1.05 to 1.36), and giving a deadline (1.18; 95% CI 1.03 to 1.34). The odds of response tripled when a picture was included in an e-mail (3.05; 95% CI 1.84 to 5.06; P = 0.27, I(2) = 19%). The odds of response were reduced when "Survey" was mentioned in the e-mail subject line (0.81; 95% CI 0.67 to 0.97; P = 0.33, I(2) = 0%), and when the e-mail included a male signature (0.55; 95% CI 0.38 to 0.80; P = 0.96, I(2) = 0%). AUTHORS' CONCLUSIONS: Health researchers using postal and electronic questionnaires can increase response using the strategies shown to be effective in this systematic review.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5488,

title = {Hypothermia for traumatic head injury.},

author = {Emma Sydenham and Ian Roberts and Phil Alderson},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5488/},

year  = {2009},

date = {2009-04-01},

journal = {The Cochrane database of systematic reviews},

volume = {2},

number = {2},

pages = {CD001048--},

publisher = {Cochrane Collaboration},

abstract = {BACKGROUND: Hypothermia has been used in the treatment of head injury for many years. Encouraging results from small trials and laboratory studies led to renewed interest in the area and some larger trials. OBJECTIVES: To estimate the effect of mild hypothermia for traumatic head injury on mortality and long-term functional outcome complications. SEARCH STRATEGY: We searched the Injuries Group Specialised Register, Current Controlled Trials MetaRegister of trials, Zetoc, ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S), CENTRAL (The Cochrane Library), MEDLINE and EMBASE. We handsearched conference proceedings and checked reference lists of all relevant articles. The search was last updated in January 2009. SELECTION CRITERIA: Randomised controlled trials of hypothermia to a maximum of 35 degrees C for at least 12 consecutive hours versus control in patients with any closed traumatic head injury requiring hospitalisation. Two authors independently assessed all trials. DATA COLLECTION AND ANALYSIS: Data on death, Glasgow Outcome Scale and pneumonia were sought and extracted, either from published material or by contacting the investigators. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each trial on an intention-to-treat basis. MAIN RESULTS: We found 23 trials with a total of 1614 randomised patients. Twenty-one trials involving 1587 patients reported deaths. There were fewer deaths in patients treated with hypothermia than in the control group (OR 0.84, 95% CI 0.67 to 1.05). Nine trials with good allocation concealment showed no decrease in the likelihood of death compared with the control group, and this result was not statistically significant (OR 1.08, 95% CI 0.79 to 1.47). Twenty-one trials involving 1587 patients reported data on unfavourable outcomes (death, vegetative state or severe disability). Patients treated with hypothermia were less likely to have an unfavourable outcome than those in the control group (OR 0.76, 95% CI 0.61 to 0.93). Nine trials with good allocation concealment showed patients treated with hypothermia were less likely to have an unfavourable outcome than those in the control group, but the reduction was small and non-significant (OR 0.91, 95% CI 0.69 to 1.20). Hypothermia treatment was associated with a slight increase in the odds of pneumonia (OR 1.31, 95% CI 0.93 to 1.86) but there was a reduction in pneumonia for trials with good allocation concealment (4 trials analysed separately, 294 patients, OR 0.79, 95% CI 0.49 to 1.27) although in both cases the results are not statistically significant. AUTHORS' CONCLUSIONS: There is no evidence that hypothermia is beneficial in the treatment of head injury. Hypothermia may be effective in reducing death and unfavourable outcomes for traumatic head injured patients, but significant benefit was only found in low quality trials. Low quality trials have a tendency to overestimate the treatment effect. The high quality trials found no decrease in the likelihood of death with hypothermia, but this finding was not statistically significant and could be due to the play of chance. Hypothermia should not be used except in the context of a high quality randomised controlled trial with good allocation concealment.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5577,

title = {The NHS carbon reduction strategy.},

author = {Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5577/},

year  = {2009},

date = {2009-01-01},

journal = {BMJ (Clinical research ed)},

volume = {338},

number = {jan28},

pages = {b326--},

publisher = {BMJ Publishing Group},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm989705,

title = {Area-wide traffic calming for preventing traffic related injuries},

author = {F Bunn and T Collier and C Frost and K Ker and R Steinbach and I Roberts and R Wentz},

url = {http://researchonline.lshtm.ac.uk/id/eprint/989705/},

year  = {2009},

date = {2009-01-01},

journal = {The Cochrane database of systematic reviews},

number = {4},

publisher = {Cochrane Collaboration},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5457,

title = {Population adiposity and climate change.},

author = {Phil Edwards and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5457/},

year  = {2009},

date = {2009-01-01},

journal = {International journal of epidemiology},

volume = {38},

number = {4},

pages = {1137--1140},

publisher = {Oxford University Press (OUP)},

abstract = {BACKGROUND: The increasing global prevalence of overweight and obesity has serious implications for the environment, as well as for health. We estimate the impact on greenhouse gas emissions of increases in the population distribution of body mass index (BMI). METHODS: We estimated the food energy required to maintain basal metabolic rate in two hypothetical adult populations using the Schofield equations for males and females. Additional greenhouse gas emissions due to higher fuel energy use for transporting a heavier population were estimated. RESULTS: Compared with a normal population distribution of BMI, a population with 40% obese requires 19% more food energy for its total energy expenditure. Greenhouse gas emissions from food production and car travel due to increases in adiposity in a population of 1 billion are estimated to be between 0.4 Giga tonnes (GT) and 1.0 GT of carbon dioxide equivalents per year. CONCLUSIONS: The maintenance of a healthy BMI has important environmental benefits in terms of lower greenhouse gas emissions.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4960,

title = {Anti-fibrinolytic agents in post partum haemorrhage: a systematic review.},

author = {Pili Ferrer and Ian Roberts and Emma Sydenham and Karen Blackhall and Haleema Shakur-Still},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4960/},

year  = {2009},

date = {2009-01-01},

journal = {BMC pregnancy and childbirth},

volume = {9},

number = {1},

pages = {29--},

publisher = {BMC},

abstract = {BACKGROUND: Post partum haemorrhage is a leading cause of maternal death worldwide. It also contributes to maternal morbidity as women may require a hysterectomy to control bleeding, or may require a blood transfusion, which can transmit viral infections. Anti-fibrinolytic agents have been proposed as a treatment for post partum haemorrhage. We conducted a systematic review to assess the effectiveness and safety of anti-fibrinolytic agents in post partum bleeding. METHODS: All randomised controlled trials of anti-fibrinolytic agents given for bleeding during the postpartum period were included in this review. We searched Medline, PubMed, EMBASE, Cochrane Central Register of Controlled trials, Web of Science, metaRegister of controlled trials, LILACS, Reproductive Health Library, African healthline, POPLINE, MedCarib, CINAHL, Clinicaltrials.gov and the reference lists of eligible trials. Two authors extracted data. Methodological quality was assessed by evaluating allocation concealment. The primary outcome was maternal mortality. Secondary outcomes were blood loss, blood transfusion, hysterectomy, mean haemoglobin concentration, thrombo-embolic events and other adverse effects. RESULTS: We identified three randomised controlled trials involving 461 participants. The trials compared tranexamic acid with no treatment and reported blood loss after delivery. In all three trials, allocation concealment was either inadequate or unclear. The administration of tranexamic acid was associated with a reduction in blood loss of 92 millilitres (95%CI 76 to 109). The most frequently reported adverse effect of tranexamic acid was nausea, although the increase was easily compatible with the play of chance (RR 4.63, 95%CI 0.23 to 95.14). CONCLUSION: Tranexamic acid may reduce blood loss in post partum haemorrhage. However, the quality of the currently available evidence is poor. Adequately powered, high quality randomised controlled trials are needed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5670,

title = {Txt2stop: a pilot randomised controlled trial of mobile phone-based smoking cessation support.},

author = {C Free and R Whittaker and R Knight and T Abramsky and A Rodgers and IG Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5670/},

year  = {2009},

date = {2009-01-01},

journal = {Tobacco control},

volume = {18},

number = {2},

pages = {88--91},

publisher = {BMJ Publishing Group},

abstract = {AIM: To conduct a pilot randomised controlled trial of mobile phone-based smoking cessation support intervention for the UK population. DESIGN: Randomised controlled trial (txt2stop). SETTING: Community. PARTICIPANTS: 200 participants responding to radio, poster and leaflet-based promotions regarding the trial. MAIN OUTCOME MEASURES: The response rate for the outcome measures planned for the main trial. Participants' qualitative responses to open-ended questions about the intervention content. Secondary outcomes were the outcomes planned for the main trial including the point prevalence of self-reported smoking at 4 weeks and pooled effect estimate for the short-term results for the STOMP and txt2stop trials. RESULTS: The response rate at 4 weeks was 96% and at 6 months was 92%. The results at 4 weeks show a doubling of self-reported quitting relative risk (RR) 2.08 (95% CI 1.11 to 3.89), 26% vs 12%. The pooled effect estimate combining txt2stop and a previous New Zealand trial in the short term is RR 2.18 (95% CI 1.79 to 2.65). CONCLUSIONS: Mobile phone-based smoking cessation is an innovative means of delivering smoking cessation support, which doubles the self-reported quit rate in the short term. It could represent an important, but as yet largely unused, medium to deliver age-appropriate public health measures. The long-term effect of this mobile phone-based smoking cessation support will be established by a large randomised controlled trial currently in recruitment.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4386,

title = {Public health benefits of strategies to reduce greenhouse-gas emissions: food and agriculture.},

author = {Sharon Friel and Alan D Dangour and Tara Garnett and Karen Lock and Zaid Chalabi and Ian Roberts and Ainslie Butler and Colin D Butler and Jeff Waage and Anthony J McMichael and Andy Haines},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4386/},

year  = {2009},

date = {2009-01-01},

journal = {Lancet},

volume = {374},

number = {9706},

pages = {2016--2025},

publisher = {Elsevier},

abstract = {Agricultural food production and agriculturally-related change in land use substantially contribute to greenhouse-gas emissions worldwide. Four-fifths of agricultural emissions arise from the livestock sector. Although livestock products are a source of some essential nutrients, they provide large amounts of saturated fat, which is a known risk factor for cardiovascular disease. We considered potential strategies for the agricultural sector to meet the target recommended by the UK Committee on Climate Change to reduce UK emissions from the concentrations recorded in 1990 by 80% by 2050, which would require a 50% reduction by 2030. With use of the UK as a case study, we identified that a combination of agricultural technological improvements and a 30% reduction in livestock production would be needed to meet this target; in the absence of good emissions data from Brazil, we assumed for illustrative purposes that the required reductions would be the same for our second case study in São Paulo city. We then used these data to model the potential benefits of reduced consumption of livestock products on the burden of ischaemic heart disease: disease burden would decrease by about 15% in the UK (equivalent to 2850 disability-adjusted life-years [DALYs] per million population in 1 year) and 16% in São Paulo city (equivalent to 2180 DALYs per million population in 1 year). Although likely to yield benefits to health, such a strategy will probably encounter cultural, political, and commercial resistance, and face technical challenges. Coordinated intersectoral action is needed across agricultural, nutritional, public health, and climate change communities worldwide to provide affordable, healthy, low-emission diets for all societies.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4319,

title = {Public health benefits of strategies to reduce greenhouse-gas emissions: overview and implications for policy makers},

author = {Andy Haines and Anthony J McMichael and Kirk R Smith and Ian Roberts and James Woodcock and Anil Markandya and Ben G Armstrong and Diarmid Campbell-Lendrum and Alan D Dangour and Michael Davies and Nigel Bruce and Cathryn Tonne and Mark Barrett and Paul Wilkinson},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4319/},

year  = {2009},

date = {2009-01-01},

journal = {Lancet},

volume = {374},

number = {9707},

pages = {2104--2114},

publisher = {Elsevier},

abstract = {This Series has examined the health implications of policies aimed at tackling climate change. Assessments of mitigation strategies in four domains-household energy, transport, food and agriculture, and electricity generation-suggest an important message: that actions to reduce greenhouse-gas emissions often, although not always, entail net benefits for health. In some cases, the potential benefits seem to be substantial. This evidence provides an additional and immediate rationale for reductions in greenhouse-gas emissions beyond that of climate change mitigation alone. Climate change is an increasing and evolving threat to the health of populations worldwide. At the same time, major public health burdens remain in many regions. Climate change therefore adds further urgency to the task of addressing international health priorities, such as the UN Millennium Development Goals. Recognition that mitigation strategies can have substantial benefits for both health and climate protection offers the possibility of policy choices that are potentially both more cost effective and socially attractive than are those that address these priorities independently.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4467,

title = {Aligning climate change and public health policies.},

author = {Andy Haines and Paul Wilkinson and Cathryn Tonne and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4467/},

year  = {2009},

date = {2009-01-01},

journal = {Lancet},

volume = {374},

number = {9707},

pages = {2035--2038},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4624,

title = {The risk of transfusion-transmitted infections in sub-Saharan Africa.},

author = {Sudha Jayaraman and Zaid Chalabi and Pablo Perel and Carla Guerriero and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4624/},

year  = {2009},

date = {2009-01-01},

journal = {Transfusion},

volume = {50},

number = {2},

pages = {433--442},

publisher = {Wiley},

abstract = {BACKGROUND: Blood transfusions carry the risk of transmitting infections. This risk has been studied in detail in high-income countries but not in sub-Saharan Africa. This study estimates the risks of acquiring human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) from a single unit of blood in sub-Saharan Africa. STUDY DESIGN AND METHODS: A mathematical model was constructed to quantify transfusion risks across 45 sub-Saharan African countries using three components: the risk of a contaminated unit entering the blood supply, the risk that the unit will be given to a susceptible patient, and the risk that receipt of the unit will lead to infection in the recipient. Variables included prevalence of infection in donors, extent of blood testing, test sensitivity, and susceptibility of recipients. Data from the World Health Organization (WHO) African Region and a systematic review of the literature were used to parameterize the model. Uncertainty in the risk estimates was quantified using probabilistic sensitivity analysis. RESULTS: The median overall risks of becoming infected with HIV, HBV, and HCV from a blood transfusion in sub-Saharan Africa were 1, 4.3, and 2.5 infections per 1000 units, respectively. If annual transfusion requirements projected by the WHO were met, transfusions alone would be responsible for 28,595 HBV infections, 16,625 HCV infections, and 6650 HIV infections every year. Sensitivity analysis suggests that the true risks may be even higher. CONCLUSIONS: This study is the first to systematically quantify the risks of transfusion-transmitted infections across sub-Saharan Africa. Although the results are limited by the quality and quantity of available data, these may be the most reliable estimates at this time.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm1987651,

title = {Interventions for preventing injuries caused by impaired alertness in individuals with jet lag and shift work disorder.},

author = {Katharine Ker and Philip James Edwards and Ian Roberts and Karen Blackhall and Lambert M Felix},

url = {http://researchonline.lshtm.ac.uk/id/eprint/1987651/},

year  = {2009},

date = {2009-01-01},

journal = {The Cochrane database of systematic reviews},

number = {2},

publisher = {Cochrane Collaboration},

abstract = {This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects of interventions for preventing injuries caused by impaired alertness in persons with jet lag or shift work disorder.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4535,

title = {Carbon cost of pragmatic randomised controlled trials: retrospective analysis of sample of trials.},

author = {Katy Lyle and Louise Dent and Sally Bailey and Lynn Kerridge and Ian Roberts and Ruairidh Milne},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4535/},

year  = {2009},

date = {2009-01-01},

journal = {BMJ (Clinical research ed)},

volume = {339},

number = {oct30},

pages = {b4187--},

publisher = {BMJ Publishing Group},

abstract = {OBJECTIVE: To calculate the global warming potential, in carbon dioxide (CO(2)) equivalent emissions, from a sample of pragmatic randomised controlled trials. DESIGN: Retrospective analysis. Data source Internal data held by NIHR Evaluation, Trials and Studies Coordinating Centre. Studies included All eligible pragmatic randomised controlled trials funded by the NIHR Health Technology Assessment programme during 2002 and 2003. MAIN OUTCOME MEASURE: CO(2) equivalents for trial activities calculated with standard conversion factors. RESULTS: 12 pragmatic randomised controlled trials involving more than 4800 participants and a wide range of technologies were included. The average CO(2) emission generated by the trials was 78.4 (range 42.1-112.7) tonnes. This is equivalent to that produced in one year by approximately nine people in the United Kingdom. Commuting to work by the trial team generated the most emissions (average 21 (11.5-35.0) tonnes per trial), followed by study centres' fuel use (18 (9.3-32.2) tonnes per trial), trial team related travel (15 (2.0-29.0) tonnes per trial), and participant related travel (13 (0-46.7) tonnes per trial). CONCLUSIONS: CO(2) emissions from pragmatic randomised controlled trials are generated in areas where steps could be taken to reduce them. A large proportion of the CO(2) emissions come from travel related to various aspects of a trial. The results of this research are likely to underestimate the total CO(2) emissions associated with the trials studied, because of the sources of information available. Further research is needed to explore the additional CO(2) emissions generated by clinical trials, over and above those generated by routine care. The results from this project will feed into NIHR guidelines that will advise researchers on how to reduce CO(2) emissions.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4937,

title = {Intracranial bleeding in patients with traumatic brain injury: a prognostic study.},

author = {Pablo Perel and Ian Roberts and Omar Bouamra and Maralyn Woodford and Jane Mooney and Fiona Lecky},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4937/},

year  = {2009},

date = {2009-01-01},

journal = {BMC emergency medicine},

volume = {9},

number = {1},

pages = {15--},

publisher = {BMC},

abstract = {BACKGROUND: Intracranial bleeding (IB) is a common and serious consequence of traumatic brain injury (TBI). IB can be classified according to the location into: epidural haemorrhage (EDH) subdural haemorrhage (SDH) intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH). Studies involving repeated CT scanning of TBI patients have found that IB can develop or expand in the 48 hours after injury. If IB enlarges after hospital admission and larger bleeds have a worse prognosis, this would provide a therapeutic rationale for treatments to prevent increase in the extent of bleeding. We analysed data from the Trauma Audit & Research Network (TARN), a large European trauma registry, to evaluate the association between the size of IB and mortality in patients with TBI. METHODS: We analysed 13,962 patients presenting to TARN participating hospitals between 2001 and 2008 with a Glasgow Coma Score (GCS) less than 15 at presentation or any head injury with Abbreviated Injury Scale (AIS) severity code 3 and above. The extent of intracranial bleeding was determined by the AIS code. Potential confounders were age, presenting Glasgow Coma Score, mechanism of injury, presence and nature of other brain injuries, and presence of extra-cranial injuries. The outcomes were in-hospital mortality and haematoma evacuation. We conducted a multivariable logistic regression analysis to evaluate the independent effect of large and small size of IB, in comparison with no bleeding, on patient outcomes. We also conducted a multivariable logistic regression analysis to assess the independent effect on mortality of large IB in comparison with small IB. RESULTS: Almost 46% of patients had at some type of IB. Subdural haemorrhages were present in 30% of the patients, with epidural and intraparenchymal present in approximately 22% each. After adjusting for potential confounders, we found that large IB, wherever located, was associated with increased mortality in comparison with no bleeding. We also found that large IB was associated with an increased risk of mortality in comparison with small IB. The odds ratio for mortality for large SDH, IPH and EDH, in comparison with small bleeds, were: 3.41 (95% CI: 2.684.33), 3.47 (95% CI: 2.265.33) and 2.86 (95% CI: 1.864.38) respectively. CONCLUSION: Large EDH, SDH and IPH are associated with a substantially higher probability of hospital mortality in comparison with small IB. However, the limitations of our data, such as the large proportion of missing data and lack of data on other confounding factors, such as localization of the bleeding, make the results of this report only explanatory. Future studies should also evaluate the effect of IB size on functional outcomes.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4473,

title = {Opportunity knocks: health wins from action on global warming},

author = {I Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4473/},

year  = {2009},

date = {2009-01-01},

journal = {BMJ},

volume = {339},

number = {nov25},

pages = {b4947--b4947},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5252,

title = {It's all about money.},

author = {Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5252/},

year  = {2009},

date = {2009-01-01},

journal = {Bulletin of the World Health Organization},

volume = {87},

number = {5},

pages = {400--401},

publisher = {World Health Organization (WHO)},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm5104,

title = {The health co-benefits of climate change policies: doctors have a responsibility to future generations.},

author = {Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/5104/},

year  = {2009},

date = {2009-01-01},

journal = {Clinical medicine (London, England)},

volume = {9},

number = {3},

pages = {212--213},

publisher = {Royal College of Physicians},

abstract = {Mitigating climate change presents unrivalled opportunities for improving public health. The policies that need to be implemented to reduce greenhouse gas emissions will also bring about substantial reductions in heart disease, cancer, obesity, diabetes, road deaths and injuries, and air pollution. The health benefits arise because climate change policies necessarily impact on two of the most important determinants of health: human nutrition and human movement. Although the health co-benefits of climate change policies are increasingly recognised by health professionals they are not widely appreciated by those responsible for policy. Because the existence of important health co-benefits will dramatically reduce the cost to society of taking strong action to mitigate climate change, failure to appreciate their importance could have serious environmental consequences. Health professionals have an urgent responsibility to ensure that the health benefits of environmental policies are understood by the public and by policymakers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm4468,

title = {Public health benefits of strategies to reduce greenhouse-gas emissions: urban land transport.},

author = {James Woodcock and Phil Edwards and Cathryn Tonne and Ben G Armstrong and Olu Ashiru and David Banister and Sean Beevers and Zaid Chalabi and Zohir Chowdhury and Aaron Cohen and Oscar H Franco and Andy Haines and Robin Hickman and Graeme Lindsay and Ishaan Mittal and Dinesh Mohan and Geetam Tiwari and Alistair Woodward and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/4468/},

year  = {2009},

date = {2009-01-01},

journal = {Lancet},

volume = {374},

number = {9705},

pages = {1930--1943},

publisher = {Elsevier},

abstract = {We used Comparative Risk Assessment methods to estimate the health effects of alternative urban land transport scenarios for two settings-London, UK, and Delhi, India. For each setting, we compared a business-as-usual 2030 projection (without policies for reduction of greenhouse gases) with alternative scenarios-lower-carbon-emission motor vehicles, increased active travel, and a combination of the two. We developed separate models that linked transport scenarios with physical activity, air pollution, and risk of road traffic injury. In both cities, we noted that reduction in carbon dioxide emissions through an increase in active travel and less use of motor vehicles had larger health benefits per million population (7332 disability-adjusted life-years [DALYs] in London, and 12 516 in Delhi in 1 year) than from the increased use of lower-emission motor vehicles (160 DALYs in London, and 1696 in Delhi). However, combination of active travel and lower-emission motor vehicles would give the largest benefits (7439 DALYs in London, 12 995 in Delhi), notably from a reduction in the number of years of life lost from ischaemic heart disease (10-19% in London, 11-25% in Delhi). Although uncertainties remain, climate change mitigation in transport should benefit public health substantially. Policies to increase the acceptability, appeal, and safety of active urban travel, and discourage travel in private motor vehicles would provide larger health benefits than would policies that focus solely on lower-emission motor vehicles.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm7364,

title = {How effective are some common treatments for traumatic brain injury?},

author = {Katharine Ker and Pablo Perel and Karen Blackhall and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/7364/},

year  = {2008},

date = {2008-08-01},

journal = {BMJ (Clinical research ed)},

volume = {337},

number = {aug14},

pages = {a865--},

publisher = {BMJ Publishing Group},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm7087,

title = {Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet.},

author = {Sanaa Al-Marzouki and Ian Roberts and Stephen Evans and Tom Marshall},

url = {http://researchonline.lshtm.ac.uk/id/eprint/7087/},

year  = {2008},

date = {2008-01-01},

journal = {Lancet},

volume = {372},

number = {9634},

pages = {201--},

publisher = {Elsevier},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm7529,

title = {Traffic and the risk of vehicle-related pedestrian injury: a decision analytic support tool.},

author = {Z Chalabi and I Roberts and P Edwards and J Dowie},

url = {http://researchonline.lshtm.ac.uk/id/eprint/7529/},

year  = {2008},

date = {2008-01-01},

journal = {Injury prevention},

volume = {14},

number = {3},

pages = {196--201},

publisher = {BMJ Publishing Group},

abstract = {BACKGROUND: Pedestrian injuries are a leading cause of death and disability. Transport policy decisions have a major impact on the risk of pedestrian injury, but the effects cannot usually be quantified in controlled studies. However, mathematical modeling can help to establish the injury consequences of transport policy decisions. METHODS: A stochastic mathematical model was developed to estimate the effect of alternative transport scenarios on pedestrian injury risk. The model is based on a mechanistic description of pedestrian injury causation and comprises four sub-models: vehicle dynamics, pedestrian dynamics, collision incidence, and injury severity. RESULTS: The model was used to estimate the yearly pedestrian injury rate for a baseline scenario, corresponding to current traffic conditions in London, UK, and three alternative scenarios, comprising reductions in vehicle speed, traffic volume, and vehicle mass. The model simulated a baseline injury rate of 88 per 100,000. Compared with baseline, a 15% reduction in mean speed resulted in a 21% reduction in injury rate and a 75% reduction in fatality rate. A 15% reduction in traffic volume resulted in a 14% reduction in injury rate and a 25% reduction in fatality rate. Reducing vehicle mass by 15% did not reduce the number of injuries, but a 25% reduction resulted in less severe injuries. CONCLUSIONS: The model simulated well the rates and severity of pedestrian injury corresponding to the baseline scenario and made predictions for different transport policy scenarios. However, it is offered primarily as a generic decision support tool for the assessment of alternative policies by transport authorities.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{lshtm7600,

title = {Randomized trials in vulnerable populations.},

author = {Deborah Cook and Anne Moore-Cox and Denis Xavier and François Lauzier and Ian Roberts},

url = {http://researchonline.lshtm.ac.uk/id/eprint/7600/},

year  = {2008},

date = {2008-01-01},

journal = {Clinical trials (London, England)},

volume = {5},

number = {1},

pages = {61--69},

publisher = {SAGE Publications},

abstract = {Many persons enrolled in clinical trials can be considered vulnerable, and such trials often raise concerns because of the diminished ability of vulnerable persons to consider and protect their own interests. However, this research is necessary to answer important questions, such as which interventions are effective, which have no impact, and which do more harm than good. In this article, we identified six specific challenges associated with randomized clinical trials in vulnerable populations and have suggested several potential solutions to overcome these challenges. First addressed were macro issues, such as the scope of the problem, and research capacity in terms of funding and investigators. Next, we have addressed research ethics review, informed consent, regulatory hurdles, and serious adverse event reporting. As clinical trials are expanding globally, all stakeholders (investigators, granting agencies, REBs, DSMBs, regulatory bodies, universities, hospitals, clinicians, patients, and family members) should be aware of the challenges we have outlined, and work collaboratively toward effective solutions that improve the quality, quantity, safety, and relevance of clinical trials for vulnerable persons around the world.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}