412 results found
Grootes I, Barrett JK, Ulug P, et al., 2018, Predicting risk of rupture and rupture-preventing re-interventions utilising repeated measures on aneurysm sac diameter following endovascular abdominal aortic aneurysm repair, British Journal of Surgery, Vol: 105, Pages: 1294-1304, ISSN: 1365-2168
BackgroundClinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. The aim of this study was to develop a dynamic prognostic model to enable stratification of patients at risk of future secondary aortic rupture or the need for intervention to prevent rupture (rupture‐preventing reintervention) to enable the development of personalized surveillance intervals.MethodsBaseline data and repeat measurements of postoperative aneurysm sac diameter from the EVAR‐1 and EVAR‐2 trials were used to develop the model, with external validation in a cohort from a single‐centre vascular database. Longitudinal mixed‐effects models were fitted to trajectories of sac diameter, and model‐predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models.ResultsSome 785 patients from the EVAR trials were included, of whom 155 (19·7 per cent) experienced at least one rupture or required a rupture‐preventing reintervention during follow‐up. An increased risk was associated with preoperative AAA size, rate of sac growth and the number of previously detected complications. A prognostic model using predicted sac growth alone had good discrimination at 2 years (C‐index 0·68), 3 years (C‐index 0·72) and 5 years (C‐index 0·75) after operation and had excellent external validation (C‐index 0·76–0·79). More than 5 years after operation, growth rates above 1 mm/year had a sensitivity of over 80 per cent and specificity over 50 per cent in identifying events occurring within 2 years.ConclusionSecondary sac growth is an important predictor of rupture or rupture‐preventing reintervention to enable the development of personalized surveillance intervals. A dynamic prognostic model has the potential to tailor surveillance by identi
Patel R, Powell JT, Sweeting MJ, et al., 2018, The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis, HEALTH TECHNOLOGY ASSESSMENT, Vol: 22, Pages: 1-+, ISSN: 1366-5278
BackgroundShort-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years.ObjectiveTo assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention.DesignTwo national, multicentre randomised controlled trials: EVAR-1 and EVAR-2.SettingPatients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004.ParticipantsMen and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1 : 1 to either EVAR (n = 626) or OR (n = 626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (n = 197) or no intervention (n = 207) in EVAR-2. There was no blinding.InterventionsEVAR, OR or no intervention.Main outcome measuresThe primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness.ResultsIn EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 1.27; p = 0.14]. At 0–6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0.61, 95% CI 0.37 to 1.02 for total mort
Powell JT, IMPROVE Trail Investigators, 2017, Comparative clinical effectiveness and cost-effectiveness of an endovascular strategy versus open repair for ruptured abdomina aortic aneurysm: 3-year results of the IMPROVE randomised trial, British Medical Journal, Vol: 359, ISSN: 0959-8138
Objective To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 in UK, one in Canada), 2009-16.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture.Interventions 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture).Main outcome measures Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures.Results The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a gain in average quality
Sweeting MJ, Patel R, Powell JT, et al., 2017, Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: very long-term follow-up in the EVAR-2 randomized controlled trial, Annals of Surgery, Vol: 266, Pages: 713-719, ISSN: 0003-4932
OBJECTIVE: The aim of the study was to compare long-term total and aneurysm-related mortality in physically frail patients with abdominal aortic aneurysm (AAA) randomized to either early endovascular aneurysm repair (EVAR) or no-intervention. SUMMARY BACKGROUND DATA: EVAR-2 remains the sole randomized trial to identify whether EVAR reduces mortality in patients physically ineligible for open repair. METHODS: Between September 1999 and August 2004, 404 patients from 33 centers in the United Kingdom aged ≥60 years with AAA >5.5 cm in diameter were randomized 1:1 using computer-generated sequences of randomly permuted blocks stratified by center to receive either EVAR (197) or no-intervention (207). The primary analysis compared total and aneurysm-related deaths in groups until June 30, 2015 (mean, 12.0 yrs; maximum 14.1 yrs). RESULTS: Mean follow-up until death or censoring was 4.2 years. There were 187 deaths (22.6 per 100 person-yrs) in the EVAR group and 194 (22.1 per 100 person-yrs) in the no-intervention group. By 12 years of follow-up the estimated survival was 5.3% [95% confidence interval (CI), 2.6-9.2] in the EVAR group and 8.5% (95% CI, 5.2-12.9) in the no-intervention group; there was no significant difference in life expectancy between the groups (both 4.2 yrs; P = 0.97). However, overall aneurysm-related mortality was significantly lower in the EVAR group [3.3 deaths per 100 person-yrs compared with 6.5 deaths per 100 person-yrs in the no-intervention group, adjusted hazard ratio 0.55 (95% CI, 0.34-0.91; P = 0.019)]. Patients surviving beyond 8 years were younger, with higher body mass index, estimated glomerular filtration rate, and forced expiratory volume in 1 second. CONCLUSIONS: EVAR does not increase overall life expectancy in patients ineligible for open repair, but can reduce aneurysm-related mortality.
Powell JT, Sweeting MJ, Ulug P, et al., 2017, Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years, British Journal of Surgery, Vol: 104, Pages: 166-178, ISSN: 1365-2168
BackgroundThe erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation.MethodsAn individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention.ResultsThe analysis included 2783 patients, with 14 245 person-years of follow-up (median 5·5 years). Early (0–6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P = 0·022) in the period from 6 months to 4 years after randomization.ConclusionThe early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5 years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle : brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1
Patel R, Sweeting MJ, Powell JT, et al., 2016, Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial, Lancet, Vol: 388, Pages: 2366-2374, ISSN: 1474-547X
BackgroundShort-term survival benefits of endovascular aneurysm repair (EVAR) versus open repair of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is lost after a few years. We investigated whether EVAR had a long-term survival benefit compared with open repair.MethodsWe used data from the EVAR randomised controlled trial (EVAR trial 1), which enrolled 1252 patients from 37 centres in the UK between Sept 1, 1999, and Aug 31, 2004. Patients had to be aged 60 years or older, have aneurysms of at least 5·5 cm in diameter, and deemed suitable and fit for either EVAR or open repair. Eligible patients were randomly assigned (1:1) using computer-generated sequences of randomly permuted blocks stratified by centre to receive either EVAR (n=626) or open repair (n=626). Patients and treating clinicians were aware of group assignments, no masking was used. The primary analysis compared total and aneurysm-related deaths in groups until mid-2015 in the intention-to-treat population. This trial is registered at ISRCTN (ISRCTN55703451).FindingsWe recruited 1252 patients between Sept 1, 1999, and Aug 31, 2004. 25 patients (four for mortality outcome) were lost to follow-up by June 30, 2015. Over a mean of 12·7 years (SD 1·5; maximum 15·8 years) of follow-up, we recorded 9·3 deaths per 100 person-years in the EVAR group and 8·9 deaths per 100 person-years in the open-repair group (adjusted hazard ratio [HR] 1·11, 95% CI 0·97–1·27, p=0·14). At 0–6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0·61, 95% CI 0·37–1·02 for total mortality; and 0·47, 0·23–0·93 for aneurysm-related mortality, p=0·031), but beyond 8 years of follow-up open-repair had a significantly lower mortality (adjusted HR 1·25, 95% CI 1·00–1·56, p=0&mi
Grieve R, Gomes M, Sweeting MJ, et al., 2015, Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial., European Heart Journal, Vol: 36, Pages: 2061-2069, ISSN: 1522-9645
AIMS: To report the longer term outcomes following either a strategy of endovascular repair first or open repair of ruptured abdominal aortic aneurysm, which are necessary for both patient and clinical decision-making. METHODS AND RESULTS: This pragmatic multicentre (29 UK and 1 Canada) trial randomized 613 patients with a clinical diagnosis of ruptured aneurysm; 316 to an endovascular first strategy (if aortic morphology is suitable, open repair if not) and 297 to open repair. The principal 1-year outcome was mortality; secondary outcomes were re-interventions, hospital discharge, health-related quality-of-life (QoL) (EQ-5D), costs, Quality-Adjusted-Life-Years (QALYs), and cost-effectiveness [incremental net benefit (INB)]. At 1 year, all-cause mortality was 41.1% for the endovascular strategy group and 45.1% for the open repair group, odds ratio 0.85 [95% confidence interval (CI) 0.62, 1.17], P = 0.325, with similar re-intervention rates in each group. The endovascular strategy group and open repair groups had average total hospital stays of 17 and 26 days, respectively, P < 0.001. Patients surviving rupture had higher average EQ-5D utility scores in the endovascular strategy vs. open repair groups, mean differences 0.087 (95% CI 0.017, 0.158), 0.068 (95% CI -0.004, 0.140) at 3 and 12 months, respectively. There were indications that QALYs were higher and costs lower for the endovascular first strategy, combining to give an INB of £3877 (95% CI £253, £7408) or €4356 (95% CI €284, €8323). CONCLUSION: An endovascular first strategy for management of ruptured aneurysms does not offer a survival benefit over 1 year but offers patients faster discharge with better QoL and is cost-effective. CLINICAL TRIAL REGISTRATION: ISRCTN 48334791.
Epstein D, Sculpher MJ, Powell JT, et al., 2014, Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials., Br J Surg, Vol: 101, Pages: 623-631
BACKGROUND: A number of published economic evaluations of elective endovascular aneurysm repair (EVAR) versus open repair for abdominal aortic aneurysm (AAA) have come to differing conclusions about whether EVAR is cost-effective. This paper reviews the current evidence base and presents up-to-date cost-effectiveness analyses in the light of results of four randomized clinical trials: EVAR-1, DREAM, OVER and ACE. METHODS: Markov models were used to estimate lifetime costs from a UK perspective and quality-adjusted life-years (QALYs) based on the results of each of the four trials. The outcomes included in the model were: procedure costs, surveillance costs, reintervention costs, health-related quality of life, aneurysm-related mortality and other-cause mortality. Alternative scenarios about complications, reinterventions and deaths beyond the trial were explored. RESULTS: Models based on the results of the EVAR-1, DREAM or ACE trials did not find EVAR to be cost-effective at thresholds used in the UK (up to £30,000 per QALY). EVAR seemed cost-effective according to models based on the OVER trial. These results seemed robust to alternative model scenarios about events beyond the trial intervals. CONCLUSION: These analyses did not find that EVAR is cost-effective compared with open repair in the long term in trials conducted in European centres. EVAR did appear to be cost-effective based on the OVER trial, conducted in the USA. Caution must be exercised when transferring the results of economic evaluations from one country to another.
Powell JT, Hinchliffe RJ, Thompson MM, et al., 2014, Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm, British Journal of Surgery, Vol: 101, Pages: 216-224, ISSN: 1365-2168
Background: Single-centre series of the management of patients with ruptured abdominal aorticaneurysm (AAA) are usually too small to identify clinical factors that could improve patient outcomes.Methods: IMPROVE is a pragmatic, multicentre randomized clinical trial in which eligible patients witha clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair(EVAR) or to open repair. The influences of time and manner of hospital presentation, fluid volumestatus, type of anaesthesia, type of endovascular repair and time to aneurysm repair on 30-day mortalitywere investigated according to a prespecified plan, for the subgroup of patients with a proven diagnosisof ruptured or symptomatic AAA. Adjustment was made for potential confounding factors.Results: Some 558 of 613 randomized patients had a symptomatic or ruptured aneurysm: diagnosticaccuracy was 91·0 per cent. Patients randomized outside routine working hours had higher operativemortality (adjusted odds ratio (OR) 1·47, 95 per cent confidence interval 1·00 to 2·17). Mortality ratesafter primary and secondary presentation were similar. Lowest systolic blood pressure was stronglyand independently associated with 30-day mortality (51 per cent among those with pressure below 70mmHg). Patients who received EVAR under local anaesthesia alone had greatly reduced 30-day mortalitycompared with those who had general anaesthesia (adjusted OR 0·27, 0·10 to 0·70).Conclusion: These findings suggest that the outcome of ruptured AAA might be improved by wider useof local anaesthesia for EVAR and that a minimum blood pressure of 70 mmHg is too low a thresholdfor permissive hypotension.
Powell JT, Sweeting MJ, Thompson MM, et al., 2014, Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial, British Medical Journal, Vol: 348, Pages: 1-12, ISSN: 1468-5833
Objective To assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 UK, 1 Canadian), 2009-13.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm.Interventions 316 patients were randomised to the endovascular strategy (275 confirmed ruptures, 174 anatomically suitable for endovascular repair) and 297 to open repair (261 confirmed ruptures).Main outcome measures 30 day mortality, with 24 hour and in-hospital mortality, costs, and time and place of discharge as secondary outcomes.Results 30 day mortality was 35.4% (112/316) in the endovascular strategy group and 37.4% (111/297) in the open repair group: odds ratio 0.92 (95% confidence interval 0.66 to 1.28; P=0.62); odds ratio after adjustment for age, sex, and Hardman index 0.94 (0.67 to 1.33). Women may benefit more than men (interaction test P=0.02) from the endovascular strategy: odds ratio 0.44 (0.22 to 0.91) versus 1.18 (0.80 to 1.75). 30 day mortality for patients with confirmed rupture was 36.4% (100/275) in the endovascular strategy group and 40.6% (106/261) in the open repair group (P=0.31). More patients in the endovascular strategy than in the open repair group were discharged directly to home (189/201 (94%) v 141/183 (77%); P<0.001). Average 30 day costs were similar between the randomised groups, with an incremental cost saving for the endovascular strategy versus open repair of £1186 (€1420; $1939) (95% confidence interval −£625 to £2997).Conclusions A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost. Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women.
Greenhalgh RM, 2013, Vascular and Endovascular Challenges update, Publisher: Biba Publishing
von Allmen RS, Anjum A, Greenhalgh RM, et al., 2012, Explaining the reduction in mortality from abdominal aortic aneurysm rupture: an analysis in England and Wales between 1996-2009, 99th Annual Congress of the Swiss-Society-of-Surgery, Publisher: WILEY-BLACKWELL, Pages: 20-20, ISSN: 0007-1323
Wyss TR, Dick F, Brown LC, et al., 2012, The influence of thrombus, calcification, angulation, and tortuosity of attachment sites on the time to the first graft-related complication after endovascular aneurysm repair, 99th Annual Congress of the Swiss-Society-of-Surgery, Publisher: WILEY-BLACKWELL, Pages: 19-19, ISSN: 0007-1323
Anjum A, von Allmen R, Greenhalgh RM, et al., 2012, Explaining the reduction in mortality from ruptured abdominal aortic aneurysm in England and Wales 1996-2009, 46th Annual Scientific Meeting of the Vascular-Society-of-Great-Britain-and-Ireland, Publisher: WILEY-BLACKWELL, Pages: 10-10, ISSN: 0007-1323
Brown LC, Powell JT, Thompson SG, et al., 2012, The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy, HEALTH TECHNOLOGY ASSESSMENT, Vol: 16, Pages: 1-+, ISSN: 1366-5278
Greenhalgh RM, 2012, Vascular and Endovascular Controversies Update, Publisher: BIBA Medical
Greenhalgh RM, Brown LC, Powell JT, et al., 2011, Letter to "Rate and Predictability of Graft Rupture and Open Abdominal Aortic Surgery" Reply, ANNALS OF SURGERY, Vol: 254, Pages: 834-834, ISSN: 0003-4932
Brown LC, Thompson SG, Greenhalgh RM, et al., 2011, Incidence of cardiovascular events and death after open or endovascular repair of abdominal aortic aneurysm in the randomized EVAR trial 1, BRITISH JOURNAL OF SURGERY, Vol: 98, Pages: 935-942, ISSN: 0007-1323
Brown LC, Greenhalgh RM, Powell JT, et al., 2011, Use of baseline factors to predict serious complications and re-interventions after endovascular aneurysm repair (EVAR) in patients with a large abdominal aortic aneurysm: Results from the UK EVAR trials, 45th Annual Scientific Meeting of the Vascular-Society-of-Great-Britain-and-Ireland, Publisher: WILEY-BLACKWELL, Pages: 7-7, ISSN: 0007-1323
Wyss TR, Brown LC, Powell JT, et al., 2011, Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR trials, 45th Annual Scientific Meeting of the Vascular-Society-of-Great-Britain-and-Ireland, Publisher: WILEY-BLACKWELL, Pages: 10-10, ISSN: 0007-1323
Brown LC, Greenhalgh RM, Powell JT, et al., 2011, Use of Baseline Factors to Predict Complications and Reinterventions After Endovascular Repair of Abdominal Aneurysm, Journal of Vascular Surgery, Vol: 53, Pages: 248-248
Greenhalgh RM, 2011, The influence of thrombus, calcification, angulation and tortuosity of attachment sites on the time to the first graft-related complication after endovascular aneurysm repair, Journal of Vascular Surgery
Greenhalgh RM, 2011, Born to be a surgeon, Publisher: Biba Publishing
Greenhalgh RM, 2011, Vascular and Endovascular Consensus Update, Publisher: Biba Publishing
Greenhalgh RM, 2011, The United Kingdom Endovascular Aneurysm Repair (EVAR) Trials: Randomised Trials of EVAR versus standard therapy, HTA Journal Series
Wyss TR, Brown LC, Powell JT, et al., 2010, Rate and Predictability of Graft Rupture After Endovascular and Open Abdominal Aortic Aneurysm Repair Data From the EVAR Trials, ANNALS OF SURGERY, Vol: 252, Pages: 805-811, ISSN: 0003-4932
Greenhalgh RM, Brown LC, Powell JT, 2010, Endovascular Repair of Abdominal Aortic Aneurysm REPLY, NEW ENGLAND JOURNAL OF MEDICINE, Vol: 363, Pages: 1481-1482, ISSN: 0028-4793
Brown LC, Greenhalgh RM, Powell JT, et al., 2010, Use of baseline factors to predict complications and reinterventions after endovascular repair of abdominal aortic aneurysm, BRITISH JOURNAL OF SURGERY, Vol: 97, Pages: 1207-1217, ISSN: 0007-1323
Sweeting MJ, Thompson SG, Brown LC, et al., 2010, Use of angiotensin converting enzyme inhibitors is associated with increased growth rate of abdominal aortic aneurysms, JOURNAL OF VASCULAR SURGERY, Vol: 52, Pages: 1-4, ISSN: 0741-5214
Powell JT, Thompson MM, Thompson SG, et al., 2010, Getting research in the NHS started, LANCET, Vol: 375, Pages: 2072-2072, ISSN: 0140-6736
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