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1. Effects of Antenatal Betamethasone on Fetal Doppler Indices and Short Term Fetal Heart Rate Variation in Early Growth Restricted Fetuses

Author

Fratelli, N., Prefumo, F., Wolf, H., Hecher, K., Visser, G.H.A., Giussani, D., Derks, J.B., Shaw, C.J., Frusca, T., Ghi, T., Ferrazzi, E., Lees, C.C., Arabin, B., Bilardo, C.M., Brezinka, C., Diemert, A., Duvekot, J.J., Ganzevoort, W., Marlow, N., Martinelli, P., Ostermayer, E., Papageorghiou, A.T., Schlembach, D., Schneider, K.T.M., Thilaganathan, B., Thornton, J., Todros, T., Valcamonico, A., Wassenaer-Leemhuis, A. van, Aktas, A., Borgione, S., Chaoui, R., Cornette, J.M.J., Diehl, T., Eyck, J. van, Haastert, I.C. van, Lobmaier, S., Lopriore, E., Missfelder-Lobos, H., Mansi, G., Martelli, P., Maso, G., Maurer-Fellbaum, U., Charante, N.M. van, Tollenaer, S.M., Napolitano, R., Oberto, M., Oepkes, D., Ogge, G., Post, J.A.M. van der, Preston, L., Raimondi, F., Reiss, I.K.M., Scheepers, L.S., Skabar, A., Spaanderman, M., Weisglas-Kuperus, N., Zimmermann, A., TRUFFLE Grp, TRUFFLE Grp Authors, TRUFFLE Grp Collaborating Authors, Obstetrics & Gynecology, Pediatrics, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde, Neonatology, Amsterdam Reproduction & Development (AR&D), Fratelli, Nicola, Prefumo, Federico, Wolf, Han, Hecher, Kurt, Visser, Gerard H A, Giussani, Dino, Derks, Jan B, Shaw, Caroline J, Frusca, Tiziana, Ghi, Tullio, Ferrazzi, E, Lees, Christoph C, Truffle, Group, and Raimondi, Francesco

Subjects
medicine.medical_specialty, Cardiotocography, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], betamethasone, fetal growth restriction, obstetrics, Female, Fetal Heart, Fetus, Humans, Pregnancy, Pregnancy Outcome, Prospective Studies, Betamethasone, Fetal Growth Retardation, Glucocorticoids, Heart Rate, Fetal, Ultrasonography, Prenatal, Antenatal steroid, Fetal, 03 medical and health sciences, 0302 clinical medicine, All institutes and research themes of the Radboud University Medical Center, Heart Rate, Internal medicine, Heart rate, medicine, TRUFFLE Group, Prenatal, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Prospective cohort study, Ultrasonography, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, business.industry, Nuclear Medicine & Medical Imaging, TRUFFLE Group collaborating authors, TRUFFLE Group authors, Cardiology, business, Lower limbs venous ultrasonography, Ductus venosus, medicine.drug
Abstract

To investigate the effects of the antenatal administration of betamethasone on fetal Doppler and short term fetal heart rate variation (CTG-STV) in early growth restricted (FGR) fetuses. Post hoc analysis of data derived from the TRUFFLE study, a prospective, multicenter, randomized management trial of severe early onset FGR. Repeat Doppler and CTG-STV measurements between the last recording within 48 hours before the first dose of betamethasone (baseline value) and for 10 days after were evaluated. Multilevel analysis was performed to analyze the longitudinal course of the umbilico-cerebral ratio (UC ratio), the ductus venosus pulsatility index (DVPIV) and CTG-STV. We included 115 fetuses. A significant increase from baseline in CTG-STV was found on day + 1 (p = 0.019) but no difference thereafter. The DVPIV was not significantly different from baseline in any of the 10 days following the first dose of betamethasone (p = 0.167). Multilevel analysis revealed that, over 10 days, the time elapsed from antenatal administration of betamethasone was significantly associated with a decrease in CTG-STV (p = 0.045) and an increase in the DVPIV (p = 0.001) and UC ratio (p 0.001). Although steroid administration in early FGR has a minimal effect on increasing CTG-STV one day afterwards, the effects on Doppler parameters were extremely slight with regression coefficients of small magnitude suggesting no clinical significance, and were most likely related to the deterioration with time in FGR. Hence, arterial and venous Doppler assessment of fetal health remains informative following antenatal steroid administration to accelerate fetal lung maturation.ZIEL: Untersuchung des Effekts der antenatalen Gabe von Betamethason auf den fetalen Doppler und die Kurzzeitvariation der fetalen Herzfrequenz (CTG-STV) bei Föten mit früher Wachstumsrestriktion (FGR). Post-hoc-Analyse von Daten der TRUFFLE-Studie, einer prospektiven, multizentrischen, randomisierten Managementstudie bei schwerer, früh einsetzender FGR. Wiederholte Doppler- und CTG-STV-Messungen zwischen der letzten Aufnahme innerhalb von 48 Stunden vor der ersten Betamethason-Dosis (Ausgangswert) und über 10 Tage wurden bewertet. Eine mehrstufige Analyse erfolgte, um den longitudinalen Verlauf der umbilikal-zerebralen Ratio (UC-Ratio), des Pulsatilitätsindex des Ductus venosus (DVPIV) und der CTG-STV zu analysieren. Wir haben 115 Föten eingeschlossen. Ein signifikanter Anstieg der CTG-STV gegenüber dem Ausgangswert wurde am Tag + 1 (p = 0,019) ermittelt, danach gab es keinen Unterschied. Der DVPIV unterschied sich an keinem der 10 Tage nach erster Betamethason-Dosis signifikant vom Ausgangswert (p = 0,167). Eine mehrstufige Analyse ergab, dass die verstrichene Zeit nach der antenatalen Betamethason-Gabe über 10 Tage hinweg signifikant mit der Abnahme der CTG-STV (p = 0,045) und der Zunahme des DVPIV (p = 0,001) und der UC-Ratio (p 0,001) assoziiert war. Obwohl die Steroidverabreichung bei früher FGR eine kleine Auswirkung auf den Anstieg der CTG-STV 1 Tag darauf hatte, waren die Effekte auf die Doppler-Parameter äußerst gering mit Regressionskoeffizienten von geringer Höhe, die nicht auf klinische Signifikanz schließen lassen. Sie stehen höchstwahrscheinlich in Zusammenhang mit der Verschlechterung bei FGR im Laufe der Zeit. Daher bleibt die Beurteilung der arteriellen und venösen Doppler bezüglich des Gesundheitszustandes des Fötus aussagekräftig, nachdem diesem zur Beschleunigung der fetalen Lungenreifung antenatal Steroide verabreicht wurden.

Published
2021

3. Fetal cerebral blood-flow redistribution: analysis of Doppler reference charts and association of different thresholds with adverse perinatal outcome

Author

Wolf, H, Stampalija, T, Lees, CC, Arabin, B, Berger, A, Bergman, E, Bhide, A, Bilardo, CM, Breeze, AC, Brodszki, J, Calda, P, Cesari, E, Cetin, I, Derks, J, Ebbing, C, Ferrazzi, E, Frusca, T, Ganzevoort, W, Gordijn, SJ, Gyselaers, W, Hecher, K, Klaritsch, P, Krofta, L, Lindgren, P, Lobmaier, SM, Marlow, N, Maruotti, GM, Mecacci, F, Myklestad, K, Napolitano, R, Prefumo, F, Raio, L, Richter, J, Sande, RK, Thornton, J, Valensise, H, Visser, GHA, Wee, L, Obstetrics and Gynaecology, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, APH - Digital Health, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), Wolf, H, Stampalija, T, C Lees, C, and study group, Truffle

Subjects
Doppler, adverse outcome, brain sparing, cerebroplacental ratio, fetal growth restriction, middle cerebral artery, percentile, reference chart, umbilicocerebral ratio, Percentile, Technology, IMPACT, Placenta, Umbilical Arteries, Obstetrics and gynaecology, Pregnancy, Reference Values, FOR-GESTATIONAL-AGE, GROWTH RESTRICTION, Medicine, Prospective Studies, 610 Medicine & health, RISK, Fetal Growth Retardation, Radiological and Ultrasound Technology, Obstetrics, Radiology, Nuclear Medicine & Medical Imaging, Pregnancy Outcome, Obstetrics and Gynecology, Gestational age, Obstetrics & Gynecology, General Medicine, Original Papers, TRUFFLE Study Group, Cerebrovascular Circulation, Cohort, Gestation, Female, Life Sciences & Biomedicine, Cohort study, Adult, medicine.medical_specialty, Gestational Age, DIAGNOSIS, Risk Assessment, Ultrasonography, Prenatal, Fetus, PULSATILITY INDEX, MANAGEMENT, Humans, Placental Circulation, Radiology, Nuclear Medicine and imaging, Obstetrics & Reproductive Medicine, Original Paper, Science & Technology, business.industry, Infant, Newborn, Ultrasonography, Doppler, Odds ratio, Acoustics, REFERENCE VALUES, Reproductive Medicine, 1114 Paediatrics and Reproductive Medicine, Feasibility Studies, Observational study, business
Abstract

OBJECTIVES: First, to compare published Doppler reference charts of the ratios of flow in the fetal middle cerebral and umbilical arteries (i.e. the cerebroplacental ratio (CPR) and umbilicocerebral ratio (UCR)). Second, to assess the association of thresholds of CPR and UCR based on these charts with short-term composite adverse perinatal outcome in a cohort of pregnancies considered to be at risk of late preterm fetal growth restriction. METHODS: Studies presenting reference charts for CPR or UCR were searched for in PubMed. Formulae for plotting the median and the 10th percentile (for CPR) or the 90th percentile (for UCR) against gestational age were extracted from the publication or calculated from the published tables. Data from a prospective European multicenter observational cohort study of singleton pregnancies at risk of fetal growth restriction at 32 + 0 to 36 + 6 weeks' gestation, in which fetal arterial Doppler measurements were collected longitudinally, were used to compare the different charts. Specifically, the association of UCR and CPR thresholds (CPR

Published
2021

4. Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction : prospective cohort study

Author

Stampalija, T., Thornton, J., Marlow, N., Napolitano, R., Bhide, A., Pickles, T., Bilardo, C. M., Gordijn, S. J., Gyselaers, W., Valensise, H., Hecher, K., Sande, R. K., Lindgren, P., Bergman, E., Arabin, B., Breeze, A. C., Wee, L., Ganzevoort, W., Richter, J., Berger, A., Brodszki, J., Derks, J., Mecacci, F., Maruotti, G. M., Myklestad, K., Lobmaier, S. M., Prefumo, F., Klaritsch, P., Calda, P., Ebbing, C., Frusca, T., Raio, L., Visser, G. H. A., Krofta, L., Cetin, I., Ferrazzi, E., Cesari, E., Wolf, H., Lees, C. C., Brezinka, C., Casagrandi, D., Cerny, A., Dall'Asta, A., Devlieger, R., Duvekot, J., Eggebo, T. M., Fantasia, I., Ferrari, F., Fratelli, N., Ghi, T., Graupner, O., Greimel, P., Hofstaetter, C., Presti, D. Lo, Georg, M., Macsali, F., Marsal, K., Martinelli, P., Mylrea-Foley, B., Mullins, E., Ostermayer, E., Papageorghiou, A., Peasley, R., Ramoni, A., Sarno, L., Seikku, L., Simeone, S., Thilaganathan, B., Tiralongo, G., Valcamonico, A., van Holsbeke, C., Vietheer, A., APH - Quality of Care, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, APH - Digital Health, Stampalija, T., Thornton, J., Marlow, N., Napolitano, R., Bhide, A., Pickles, T., Bilardo, C. M., Gordijn, S. J., Gyselaers, W., Valensise, H., Hecher, K., Sande, R. K., Lindgren, P., Bergman, E., Arabin, B., Breeze, A. C., Wee, L., Ganzevoort, W., Richter, J., Berger, A., Brodszki, J., Derks, J., Mecacci, F., Maruotti, G. M., Myklestad, K., Lobmaier, S. M., Prefumo, F., Klaritsch, P., Calda, P., Ebbing, C., Frusca, T., Raio, L., Visser, G. H. A., Krofta, L., Cetin, I., Ferrazzi, E., Cesari, E., Wolf, H., Lees, C. C., Brezinka, C., Casagrandi, D., Cerny, A., Dall'Asta, A., Devlieger, R., Duvekot, J., Eggebo, T. M., Fantasia, I., Ferrari, F., Fratelli, N., Ghi, T., Graupner, O., Greimel, P., Hofstaetter, C., Presti, D. L., Georg, M., Macsali, F., Marsal, K., Martinelli, P., Mylrea-Foley, B., Mullins, E., Ostermayer, E., Papageorghiou, A., Peasley, R., Ramoni, A., Sarno, L., Seikku, L., Simeone, S., Thilaganathan, B., Tiralongo, G., Valcamonico, A., Van Holsbeke, C., Vietheer, A., and HUS Gynecology and Obstetrics

Subjects
Technology, adverse outcome, umbilical-cerebral ratio, Umbilical Arteries, umbilical artery, TRUFFLE-2 Group, Fetal Development, 0302 clinical medicine, Obstetrics and gynaecology, Pregnancy, Reference Values, 3123 Gynaecology and paediatrics, Interquartile range, Birth Weight, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Fetal Growth Retardation, 030219 obstetrics & reproductive medicine, Radiological and Ultrasound Technology, Obstetrics, Radiology, Nuclear Medicine & Medical Imaging, Doppler, Obstetrics & Gynecology, Obstetrics and Gynecology, Gestational age, General Medicine, Stillbirth, 3. Good health, ddc, Europe, Fetal Weight, Pulsatile Flow, Infant, Small for Gestational Age, Female, Waist Circumference, Rheology, Life Sciences & Biomedicine, Live Birth, middle cerebral artery, neonatal, umbilicocerebral ratio, Radiology, Nuclear Medicine and Medical Imaging, Adult, medicine.medical_specialty, Birth weight, education, 610 Medicine & health, Gestational Age, Reproduktionsmedicin och gynekologi, DIAGNOSIS, Ultrasonography, Prenatal, 03 medical and health sciences, Fetus, Obstetrics, Gynecology and Reproductive Medicine, medicine, MANAGEMENT, Humans, Radiology, Nuclear Medicine and imaging, Risk factor, Obstetrics & Reproductive Medicine, Science & Technology, business.industry, CEREBROPLACENTAL RATIO, Infant, Newborn, Ultrasonography, Doppler, Acoustics, Reproductive Medicine, Relative risk, 1114 Paediatrics and Reproductive Medicine, Radiologi och bildbehandling, business
Abstract

OBJECTIVES: To explore the association between fetal umbilical and middle cerebral artery (MCA) Doppler abnormalities and outcome in late preterm pregnancies at risk of fetal growth restriction. METHODS: This was a prospective cohort study of singleton pregnancies at risk of fetal growth restriction at 32 + 0 to 36 + 6 weeks of gestation, enrolled in 33 European centers between 2017 and 2018, in which umbilical and fetal MCA Doppler velocimetry was performed. Pregnancies were considered at risk of fetal growth restriction if they had estimated fetal weight and/or abdominal circumference (AC)

Published
2020

5. Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials

Author

Ganzevoort, W., Thornton, J. G., Marlow, N., Thilaganathan, B., Arabin, B., Prefumo, F., Lees, C., Wolf, H., Van Bulck, B, Kalakoutis, G M, Sak, P, Schneider, K T M, Karpathios, S E, Major, T, Todros, T, Arduini, D, Flumini, C, Tenore, A C, Roncaglia, N, Frusca, T, Ferretti, G, Weinans, M J N, Roosmalen, J, Slikke, J W, Geijn, H, Pernet, P J M, Wolf, H, Stigter, R H, Wilczynski, J, Vasco, E, Abdullah, M, Novak‐Antolic, Z, Danielian, P, Jenkinson, S D, Welch, C R, Griffin, C, Gee, H, Tuffnell, D, Cresswell, J, Tariq, T, Sengupta, B, Tydeman, G, Churchill, D, Bewley, S, Fusi, L, Lindow, S W, Johal, W, Fairlie, F M, Neales, K, Mason, G, Scudamore, I, Konje, J, Walkinshaw, S A, Griffiths, M, Dawson, A, Mires, G, Johanson, R, Fraser, R B, Ibbs, P Hendy, Steel, S A, Ramsay, M, Robins, J B, Heard, M J, Tonge, H M, Manyonda, I T, Walker, J, Maresh, M, Yoong, A, Soothill, P, Cameron, H, Byrne, D, Beattie, B, Bober, S, Van Damme, M, Kyriakides, S, Pokorna, P, Zimmerman, A, Tsitsikas, H, Mani, E, Bosisio, P, Mastritta, E, Nicocia, M, Fabris, C, Eken, P, De Vries, L, Kubicka, Z, Ramalho, R, Rashid, M, Cerar‐Kornhauser, L, Thomas, S, Elliman, A, Sim, T, Swaminathan, S, Walker, L, McCormick, D, Sibanda, Z, Hughes, J, Kilding, J, O'Hara, A, Harpin, V, Porter, N, Pandey, S, Murtagh, K, Burton, K, MacGregor, R, Stewart, B, Klenke, H, Hallam, P, Kai, N, Graham, M, Harrison, A, Saharia, E, McGhee, T, Rowsell, P, Howie, P, Parmar, Max, Field, D, Grant, A, Steer, P, Breart, G, Levene, M, Torgeson, D, Kitzinger, S, Marlowe, N, Wolke, Dieter, Johnson, A, Arabin, Birgit, Bilardo, Caterina M, Brezinka, Christoph, Cornette, Jerome M J, Derks, Jan B, Diemert, Anke, Duvekot, Johannes J, Ferrazzi, Enrico, Fratelli, Nicola, Frusca, Tiziana, Ganzevoort, Wessel, Hecher, Kurt, Leemhuis, Aleid, Lees, Christoph C, Lobmaier, Silvia, Marlow, Neil, Martinelli, Pasquale, Maso, Gianpaolo, Missfelder‐Lobos, Hannah, Napolitano, Raffaele, Ostermayer, Eva, Papageorghiou, Aris T, Prefumo, Federico, Schlembach, Dietmar, Thilaganathan, Baskaran, Todros, Tullia, Valcamonico, Adriana, Visser, Gerard H A, Wolf, Hans, Kingdom, John, Marsal, Karel, Thornton, Jim, Valensise, Herbert, Athena Institute, APH - Global Health, APH - Quality of Care, Obstetrics and gynaecology, Papageorghiou, AT, Obstetrics and Gynaecology, AR&D - Amsterdam Reproduction & Development, and APH - Digital Health

Subjects
short‐term variation, Technology, FLOW, INFANTS, cardiotocography, ductus venosus, fetal growth restriction, monitoring, short-term variation, Umbilical Arteries, Cohort Studies, 0302 clinical medicine, Obstetrics and gynaecology, Pregnancy, GROWTH RESTRICTION, Cardiotocography, 030212 general & internal medicine, Randomized Controlled Trials as Topic, Fetal Growth Retardation, 030219 obstetrics & reproductive medicine, Radiological and Ultrasound Technology, medicine.diagnostic_test, Obstetrics, Radiology, Nuclear Medicine & Medical Imaging, short term variation, Pregnancy Outcome, Obstetrics & Gynecology, Obstetrics and Gynecology, Gestational age, General Medicine, Original Papers, TRUFFLE Study Group, Settore MED/40, Pulsatile Flow, Gestation, Female, Life Sciences & Biomedicine, INTERVENTION, Blood Flow Velocity, Ductus venosus, Cohort study, medicine.medical_specialty, Birth weight, FETAL HEART-RATE, Ultrasonography, Prenatal, 03 medical and health sciences, SDG 3 - Good Health and Well-being, FETUSES, medicine, Humans, Radiology, Nuclear Medicine and imaging, Obstetrics & Reproductive Medicine, Fetal Death, GRIT Study Group, Original Paper, Fetus, Science & Technology, business.industry, Infant, Newborn, Acoustics, Reproductive Medicine, 1114 Paediatrics and Reproductive Medicine, business
Abstract

Objective To explore the effect on perinatal outcome of different fetal monitoring strategies for early‐onset fetal growth restriction (FGR). Methods This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P, This article's abstract has been translated into Spanish and Chinese. Follow the links from the http://onlinelibrary.wiley.com/doi/10.1002/uog.20354/abstract to view the translations. This article has been selected for Journal Club. Click https://www.isuog.org/resource/uog-journal-club-January-2020.html to view slides and discussion points.

Published
2020

6. 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

Author

Powell, JT, Sweeting, MJ, Ulug, P, Blankensteijn, JD, Lederle, FA, Becquemin, J-P, Greenhalgh, RM, Beard, JD, Buxton, MJ, Brown, LC, Harris, PL, Rose, JDG, Russell, IT, Sculpher, MJ, Thompson, SG, Lilford, RJ, Bell, PRF, Whitaker, SC, Poole-Wilson, PA, Ruckley, CV, Campbell, WB, Dean, MRE, Ruttley, MST, Coles, EC, Halliday, A, Gibbs, SJ, Epstein, D, Hannon, RJ, Johnston, L, Bradbury, AW, Henderson, MJ, Parvin, SD, Shepherd, DFC, Mitchell, AW, Edwards, PR, Abbott, GT, Higman, DJ, Vohra, A, Ashley, S, Robottom, C, Wyatt, MG, Byrne, D, Edwards, R, Leiberman, DP, McCarter, DH, Taylor, PR, Reidy, JF, Wilkinson, AR, Ettles, DF, Clason, AE, Leen, GLS, Wilson, NV, Downes, M, Walker, SR, Lavelle, JM, Gough, MJ, McPherson, S, Scott, DJA, Kessell, DO, Naylor, R, Sayers, R, Fishwick, NG, Gould, DA, Walker, MG, Chalmers, NC, Garnham, A, Collins, MA, Gaines, PA, Ashour, MY, Uberoi, R, Braithwaite, B, Davies, JN, Travis, S, Hamilton, G, Platts, A, Shandall, A, Sullivan, BA, Sobeh, M, Matson, M, Fox, AD, Orme, R, Yusef, W, Doyle, T, Horrocks, M, Hardman, J, Blair, PHB, Ellis, PK, Morris, G, Odurny, A, Vohra, R, Duddy, M, Thompson, M, Loosemore, TML, Belli, AM, Morgan, R, Adiseshiah, M, Brookes, JAS, McCollum, CN, Ashleigh, R, Aukett, M, Baker, S, Barbe, E, Batson, N, Bell, J, Blundell, J, Boardley, D, Boyes, S, Brown, O, Bryce, J, Carmichael, M, Chance, T, Coleman, J, Cosgrove, C, Curran, G, Dennison, T, Devine, C, Dewhirst, N, Errington, B, Farrell, H, Fisher, C, Fulford, P, Gough, M, Graham, C, Hooper, R, Horne, G, Horrocks, L, Hughes, B, Hutchings, T, Ireland, M, Judge, C, Kelly, L, Kemp, J, Kite, A, Kivela, M, Lapworth, M, Lee, C, Linekar, L, Mahmood, A, March, L, Martin, J, Matharu, N, McGuigen, K, Morris-Vincent, P, Murray, S, Murtagh, A, Owen, G, Ramoutar, V, Rippin, C, Rowley, J, Sinclair, J, Spencer, S, Taylor, V, Tomlinson, C, Ward, S, Wealleans, V, West, J, White, K, Williams, J, Wilson, L, Grobbee, DE, Bak, AAA, Buth, J, Pattynama, PM, Verhoeven, ELG, van Voorthuisen, AE, Balm, R, Cuypers, PWM, Prinssen, M, van Sambeek, MRHM, Baas, AF, Hunink, MG, van Engelshoven, JM, Jacobs, MJHM, de Mol, BAJM, van Bockel, JH, Reekers, J, Tielbeek, X, Wisselink, W, Boekema, N, Heuveling, LM, Sikking, I, de Bruin, JL, Buskens, E, Tielbeek, AV, Reekers, JA, Pattynama, P, Prins, T, van der Ham, AC, van der Velden, JJIM, van Sterkenburg, SMM, ten Haken, GB, Bruijninckx, CMA, van Overhagen, H, Tutein Nolthenius, RP, Hendriksz, TR, Teijink, JAW, Odink, HF, de Smet, AAEA, Vroegindeweij, D, van Loenhout, RMM, Rutten, MJ, Hamming, JF, Lampmann, LEH, Bender, MHM, Pasmans, H, Vahl, AC, de Vries, C, Mackaay, AJC, van Dortmont, LMC, van der Vliet, AJ, Schultze Kool, LJ, Boomsma, JHB, van Dop, HR, de Mol van Otterloo, JCA, de Rooij, TPW, Smits, TM, Yilmaz, EN, van den Berg, FG, Visser, MJT, van der Linden, E, Schurink, GWH, de Haan, M, Smeets, HJ, Stabel, P, van Elst, F, Poniewierski, J, Vermassen, FEG, Freischlag, JA, Kohler, TR, Latts, E, Matsumura, J, Padberg, FT, Kyriakides, TC, Swanson, KM, Guarino, P, Peduzzi, P, Antonelli, M, Cushing, C, Davis, E, Durant, L, Joyner, S, Kossack, A, LeGwin, M, McBride, V, O'Connor, T, Poulton, J, Stratton, S, Zellner, S, Snodgrass, AJ, Thornton, J, Haakenson, CM, Stroupe, KT, Jonk, Y, Hallett, JW, Hertzer, N, Towne, J, Katz, DA, Karrison, T, Matts, JP, Marottoli, R, Kasl, S, Mehta, R, Feldman, R, Farrell, W, Allore, H, Perry, E, Niederman, J, Randall, F, Zeman, M, Beckwith, D, O'Leary, TJ, Huang, GD, Bader, M, Ketteler, ER, Kingsley, DD, Marek, JM, Massen, RJ, Matteson, BD, Pitcher, JD, Langsfeld, M, Corson, JD, Goff, JM, Kasirajan, K, Paap, C, Robertson, DC, Salam, A, Veeraswamy, R, Milner, R, Guidot, J, Lal, BK, Busuttil, SJ, Lilly, MP, Braganza, M, Ellis, K, Patterson, MA, Jordan, WD, Whitley, D, Taylor, S, Passman, M, Kerns, D, Inman, C, Poirier, J, Ebaugh, J, Raffetto, J, Chew, D, Lathi, S, Owens, C, Hickson, K, Dosluoglu, HH, Eschberger, K, Kibbe, MR, Baraniewski, HM, Endo, M, Busman, A, Meadows, W, Evans, M, Giglia, JS, El Sayed, H, Reed, AB, Ruf, M, Ross, S, Jean-Claude, JM, Pinault, G, Kang, P, White, N, Eiseman, M, Jones, R, Timaran, CH, Modrall, JG, Welborn, MB, Lopez, J, Nguyen, T, Chacko, JKY, Granke, K, Vouyouka, AG, Olgren, E, Chand, P, Allende, B, Ranella, M, Yales, C, Whitehill, TA, Krupski, WC, Nehler, MR, Johnson, SP, Jones, DN, Strecker, P, Bhola, MA, Shortell, CK, Gray, JL, Lawson, JH, McCann, R, Sebastian, MW, Kistler Tetterton, J, Blackwell, C, Prinzo, PA, Lee, N, Cerveira, JJ, Zickler, RW, Hauck, KA, Berceli, SA, Lee, WA, Ozaki, CK, Nelson, PR, Irwin, AS, Baum, R, Aulivola, B, Rodriguez, H, Littooy, FN, Greisler, H, O'Sullivan, MT, Kougias, P, Lin, PH, Bush, RL, Guinn, G, Bechara, C, Cagiannos, C, Pisimisis, G, Barshes, N, Pillack, S, Guillory, B, Cikrit, D, Lalka, SG, Lemmon, G, Nachreiner, R, Rusomaroff, M, O'Brien, E, Cullen, JJ, Hoballah, J, Sharp, WJ, McCandless, JL, Beach, V, Minion, D, Schwarcz, TH, Kimbrough, J, Ashe, L, Rockich, A, Warner-Carpenter, J, Moursi, M, Eidt, JF, Brock, S, Bianchi, C, Bishop, V, Gordon, IL, Fujitani, R, Kubaska, SM, Behdad, M, Azadegan, R, Ma Agas, C, Zalecki, K, Hoch, JR, Carr, SC, Acher, C, Schwarze, M, Tefera, G, Mell, M, Dunlap, B, Rieder, J, Stuart, JM, Weiman, DS, Abul-Khoudoud, O, Garrett, HE, Walsh, SM, Wilson, KL, Seabrook, GR, Cambria, RA, Brown, KR, Lewis, BD, Framberg, S, Kallio, C, Barke, RA, Santilli, SM, d'Audiffret, AC, Oberle, N, Proebstle, C, Johnson, LL, Jacobowitz, GR, Cayne, N, Rockman, C, Adelman, M, Gagne, P, Nalbandian, M, Caropolo, LJ, Pipinos, II, Johanning, J, Lynch, T, DeSpiegelaere, H, Purviance, G, Zhou, W, Dalman, R, Lee, JT, Safadi, B, Coogan, SM, Wren, SM, Bahmani, DD, Maples, D, Thunen, S, Golden, MA, Mitchell, ME, Fairman, R, Reinhardt, S, Wilson, MA, Tzeng, E, Muluk, S, Peterson, NM, Foster, M, Edwards, J, Moneta, GL, Landry, G, Taylor, L, Yeager, R, Cannady, E, Treiman, G, Hatton-Ward, S, Salabsky, B, Kansal, N, Owens, E, Estes, M, Forbes, BA, Sobotta, C, Rapp, JH, Reilly, LM, Perez, SL, Yan, K, Sarkar, R, Dwyer, SS, Perez, S, Chong, K, Hatsukami, TS, Glickerman, DG, Sobel, M, Burdick, TS, Pedersen, K, Cleary, P, Back, M, Bandyk, D, Johnson, B, Shames, M, Reinhard, RL, Thomas, SC, Hunter, GC, Leon, LR, Westerband, A, Guerra, RJ, Riveros, M, Mills, JL, Hughes, JD, Escalante, AM, Psalms, SB, Day, NN, Macsata, R, Sidawy, A, Weiswasser, J, Arora, S, Jasper, BJ, Dardik, A, Gahtan, V, Muhs, BE, Sumpio, BE, Gusberg, RJ, Spector, M, Pollak, J, Aruny, J, Kelly, EL, Wong, J, Vasilas, P, Joncas, C, Gelabert, HA, DeVirgillio, C, Rigberg, DA, Cole, L, Marzelle, J, Sapoval, M, Favre, J-P, Watelet, J, Lermusiaux, P, Lepage, E, Hemery, F, Dolbeau, G, Hawajry, N, Cunin, P, Harris, P, Stockx, L, Chatellier, G, Mialhe, C, Fiessinger, J-N, Pagny, L, Kobeiter, H, Boissier, C, Lacroix, P, Ledru, F, Pinot, J-J, Deux, J-F, Tzvetkov, B, Duvaldestin, P, Jourdain, C, David, V, Enouf, D, Ady, N, Krimi, A, Boudjema, N, Jousset, Y, Enon, B, Blin, V, Picquet, J, L'Hoste, P, Thouveny, F, Borie, H, Kowarski, S, Pernes, J-M, Auguste, M, Desgranges, P, Allaire, E, Meaulle, P-Y, Chaix, D, Juliae, P, Fabiani, JN, Chevalier, P, Combes, M, Seguin, A, Belhomme, D, Baque, J, Pellerin, O, Favre, JP, Barral, X, Veyret, C, Peillon, C, Plissonier, D, Thomas, P, Clavier, E, Martinez, R, Bleuet, F, C, D, Verhoye, JP, Langanay, T, Heautot, JF, Koussa, M, Haulon, S, Halna, P, Destrieux, L, Lions, C, Wiloteaux, S, Beregi, JP, Bergeron, P, Patra, P, Costargent, A, Chaillou, P, D'Alicourt, A, Goueffic, Y, Cheysson, E, Parrot, A, Garance, P, Demon, A, Tyazi, A, Pillet, J-C, Lescalie, F, Tilly, G, Steinmetz, E, Favier, C, Brenot, R, Krause, D, Cercueil, JP, Vahdat, O, Sauer, M, Soula, P, Querian, A, Garcia, O, Levade, M, Colombier, D, Cardon, J-M, Joyeux, A, Borrelly, P, Dogas, G, Magnan, P-É, Branchereau, A, Bartoli, J-M, Hassen-Khodja, R, Batt, M, Planchard, P-F, Bouillanne, P-J, Haudebourg, P, Bayne, J, Gouny, P, Badra, A, Braesco, J, Nonent, M, Lucas, A, Cardon, A, Kerdiles, Y, Rolland, Y, Kassab, M, Brillu, C, Goubault, F, Tailboux, L, Darrieux, H, Briand, O, Maillard, J-C, Varty, K, Cousins, C, EVAR-1, DREAM, OVER and ACE Trialists, Surgery, ICaR - Ischemia and repair, ACS - Microcirculation, ACS - Atherosclerosis & ischemic syndromes, Halliday, A, Sweeting, Michael [0000-0003-0980-8965], Apollo - University of Cambridge Repository, and National Institute for Health Research

Subjects
Male, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Endovascular aneurysm repair, Medical and Health Sciences, law.invention, Aortic aneurysm, 0302 clinical medicine, Randomized controlled trial, DESIGN, law, Models, 80 and over, Multicenter Studies as Topic, 030212 general & internal medicine, Randomized Controlled Trials as Topic, RISK, Aged, 80 and over, Hazard ratio, Endovascular Procedures, DREAM, 11 Medical And Health Sciences, Statistical, Middle Aged, Corrigenda, Abdominal aortic aneurysm, Aortic Aneurysm, Treatment Outcome, CARDIOVASCULAR-DISEASE, Elective Surgical Procedures, Female, Reoperation, medicine.medical_specialty, and over, 03 medical and health sciences, Aneurysm, medicine, Journal Article, MANAGEMENT, Humans, Comparative Study, Abdominal, OVER and ACE Trialists, Aged, Models, Statistical, business.industry, MORTALITY, Odds ratio, medicine.disease, Surgery, Vascular Grafting, business, Abdominal surgery, Meta-Analysis, EVAR-1, Aortic Aneurysm, Abdominal
Abstract

Background The 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. Methods An individual-patient data meta-analysis of four multicentre randomized trials of EVARversus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. Results The 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. Conclusion The 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, ISRCTN55703451; DREAM (Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.

Published
2017

7. Infarct in a New Territory After Treatment Administration in the ESCAPE Randomized Controlled Trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times)

Author

Ganesh, A, Al-Ajlan, F, Sabiq, F, Assis, Z, Rempel, J, Butcher, K, Thornton, J, Kelly, P, Roy, D, Poppe, A, Jovin, T, Devlin, T, Baxter, B, Krings, T, Casaubon, L, Frei, D, Choe, H, Tampieri, D, Teitelbaum, J, Lum, C, Mandzia, J, Phillips, S, Bang, O, Almekhlafi, M, Coutts, S, Barber, P, Sajobi, T, Demchuk, A, Eesa, M, Hill, M, Goyal, M, Menon, B, and Investigators, ESCAPE Trial

Subjects
medicine.medical_specialty, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Fibrinolytic Agents, Modified Rankin Scale, law, medicine, Humans, Thrombolytic Therapy, Advanced and Specialized Nursing, medicine.diagnostic_test, Cerebral infarction, business.industry, Magnetic resonance imaging, Odds ratio, Cerebral Infarction, medicine.disease, Confidence interval, Surgery, Clinical trial, Ostium, Tissue Plasminogen Activator, Neurology (clinical), Radiology, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract

Background and Purpose— Infarct in a new previously unaffected territory (INT) is a potential complication of endovascular treatment. We applied a recently proposed methodology to identify and classify INTs in the ESCAPE randomized controlled trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times). Methods— The core laboratory identified INTs on 24-hour follow-up imaging, blinded to treatment allocation, after assessing all baseline imaging. INTs were classified into 3 types (I–III) and 2 subtypes (A/B) based on size and if catheter manipulation was likely performed across the vessel territory ostium. Logistic regression was used to understand the effect of multiple a priori identified variables on INT occurrence. Ordinal logistic regression was used to analyze the effect of INTs on modified Rankin Scale shift at 90 days. Results— From 308 patients included, 14 INTs (4.5% overall; 2.8% on follow-up noncontrast computed tomography, 11.7% on follow-up magnetic resonance imaging) were identified (5.0% in endovascular treatment arm versus 4.0% in control arm [ P =0.7]). The use of intravenous alteplase was associated with a 68% reduction in the odds of INT occurrence (3.0% with versus 9.1% without; odds ratio, 0.32; 95% confidence interval, 0.11–0.96; adjusted for age, sex, and treatment type). No other variables were associated with INTs. INT occurrence was associated with reduced probability of good clinical outcome (common odds ratio, 0.25; 95% confidence interval, 0.09–0.74; adjusted for age, type of treatment, and follow-up scan). Conclusions— INTs are uncommon, detected more frequently on follow-up magnetic resonance imaging, and affect clinical outcome. In experienced centers, endovascular treatment is likely not causal, whereas intravenous alteplase may be therapeutic. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01778335.

Published
2016

8. CLASP - A RANDOMIZED TRIAL OF LOW-DOSE ASPIRIN FOR THE PREVENTION AND TREATMENT OF PREECLAMPSIA AMONG 9364 PREGNANT-WOMEN

Author

BEROYZ, G, CASALE, R, FARREIROS, A, PALERMO, M, MARGULIES, M, VOTO, L, FABREGUES, G, RAMALINGAM, R, DAVIES, T, BRYCE, R, BOYD, W, CARMODY, F, KING, J, VACCA, A, FAY, R, WALTERS, W, ANTONAS, B, BENNETT, P, BROOM, T, CROWTHER, C, DERHAM, R, GEORGE, K, HAGUE, W, HASENHOHR, G, HEYSEN, D, KORNMAN, L, OLOUGHLIN, S, MORRIS, D, PRIDMORE, B, ROBINSON, J, SVIGOS, D, SWEET, R, BEALE, M, BENNETT, M, BOSCH, E, FISHER, C, HORRAUTZ, S, SYMINGTON, I, SZIRT, A, FORBES, K, FREEMAN, A, POPPER, E, WILSON, J, PERMEZEL, M, BOWDITCH, J, REYNOLDS, G, MOULINASSE, R, BIETLOT, Y, KIRKPATRICK, C, COULON, R, DELVOYE, P, DEMATOS, C, SIMONINI, S, LEJEUNE, B, NEERDAELS, C, ALEXANDER, S, GOESSENS, L, HANSSENS, M, SPITZ, B, VANASSCHE, A, WECKHUYSEN, R, PARBOOSINGH, J, HARMAN, C, REY, E, BURROWS, R, BELCHER, J, GARNER, P, SYLVAIN, J, NIMROD, C, THOMAS, B, DEININGER, F, LAO, T, LI, C, FRIEDMAN, S, BORNSTEIN, J, SHALIT, A, MATZKEL, A, POMERANZ, M, GELSNER, M, MANKUTA, D, WIZNITZER, A, LEVINE, S, ADEEB, N, CHANDRAN, R, NASRI, N, SHARIFF, J, ANSELL, D, LAKE, Y, GOROCHOVA, L, MERIAKRI, V, ROMANUGA, N, DOTZ, I, SHEUV, B, VIKHLYAEVA, E, ANDREEV, K, GOLUBEVA, L, GORODCOV, V, ADELANTADO, J, SANTONJA, J, HOLMBERG, H, BUCHHAVE, P, LEANDERSSON, U, LILJESTRAND, J, RYDHSTROEM, H, SWEDIN, G, BJORKLUND, A, GENNSER, G, SANDEN, M, DAHLGREN, S, HAMMARBACK, S, SMEDS, A, SIDENVALL, M, ENEROTH, E, SZABOLCS, A, DANIELSSON, I, LINDQVIST, P, HOGSTEDT, S, WALLENBURG, H, BREMER, H, BRIET, J, DEBIEMEYERINK, A, DONKERS, B, LAMPING, P, SCHIERBEEK, J, VANDERLEEUWHARMSEN, L, THE, H, VANBODEGOM, F, VANEGMONDLINDEN, A, FLU, P, KUIJKEN, J, MORREL, B, STRAUB, M, VIERHOUT, M, KEIRSE, M, VANROOSMALEN, J, HOHNER, C, HUTTEN, J, BENNEN, J, ROEX, A, WIJFFELS, T, OOSTERHOFF, H, OTTEN, J, VANDERKLEI, T, RAMONDT, J, VANDERMOER, P, DEGRAAFF, J, SIJSMA, E, DEGREVE, O, SMIT, D, SMULDERS, P, NIJHUIS, J, ZONDERVAN, H, LIND, J, SCHOOT, B, MONKHORST, M, STUT, J, VANDAM, L, VANOTTERLO, L, VLAANDEREN, W, EGGENS, J, SANTEMA, J, VERHOEFF, A, HAMID, S, JOHN, I, KHAN, G, SHAH, S, SHEIKH, E, SINHA, C, ABRAMOVICH, D, CAMPBELL, D, FISHER, P, GALL, S, HALL, M, JANDIAL, V, PARKIN, D, SMITH, N, SUTHERLAND, H, SWAPP, G, TEMPLETON, A, TERRY, P, KALAM, A, MAGEE, S, MARTIN, D, SPEARING, G, ALDERMAN, B, MURRAY, A, SUTHERST, J, HYATT, D, SAUNDERS, P, BURGESS, S, COCHRANE, G, WHITE, A, ARMSTRONG, M, MCNICHOL, E, OSBOURNE, G, PRICE, J, CRICHTON, J, EVANS, D, ANDERSON, R, HULL, M, JAMES, D, NIVEN, P, STIRRAT, G, WARDLE, P, GARDNER, P, PADGETT, L, ALAILY, A, NASH, G, GINZ, B, SMITH, M, RICHARDS, C, ARMAR, A, ARMSTRONG, N, MANNING, E, PERSAD, K, COLLINGWOOD, M, COLLINS, R, CROWTHER, J, FARRELL, B, HAFNER, B, HANDOLL, H, HEINEMAN, J, KNIGHT, S, MEAD, G, RADLEY, A, SPENCE, S, REID, W, TREHARNE, I, HEASLEY, R, LOWRY, D, MYLES, T, WALLACE, R, GEALS, M, GORDON, G, TRAIN, T, HUTCHON, D, MACDONALD, J, STOREY, R, ANDERSON, G, WORTH, R, ERIAN, J, MCQUEEN, J, TATFORD, E, TERRY, M, NEALE, R, HOWAT, R, KENNEDY, J, MACNAUGHTON, M, MCEWAN, H, WALKER, J, HUTCHESON, R, KEMP, V, READ, M, SIMMS, M, SWINGLER, G, HUSEMEYER, R, CHAPMAN, M, MAXWELL, D, ELDER, M, FUSI, L, HAWKINS, D, NICOLINI, U, WINSTON, R, BURTON, E, FAIRBANK, J, SIMMONS, S, SPING, J, TRICKEY, N, GILLARD, M, HUDSON, C, SETCHELL, M, WATHEN, N, CANTY, S, WHITELEY, P, CAMPBELL, J, FEENEY, J, HAY, D, IMRIE, A, PALMER, A, PURDIE, D, SPECK, E, TYRRELL, S, MCLEAN, J, BROWN, V, DUNCAN, S, JOHNSON, D, MILLAR, D, BUCKLEY, D, CHARNOCK, M, DOVE, P, ELLIS, J, GILLMER, M, MCVITTIE, J, MANNION, V, REDMAN, C, SELLERS, S, TURNBULL, A, NEWMAN, M, CAMPBELL, S, CARDOSO, L, GIBB, D, HARRINGTON, K, PARSONS, J, NICOLAIDES, K, STUDD, J, DIXON, R, GIE, C, PICKLES, C, SEAR, R, GRAHAM, R, KIRWAN, P, SMITH, G, ANWAR, M, ALAZZAWI, F, DAVIDSON, A, DECHAZEL, R, DRIFE, J, GILL, F, LANG, G, MACAFEE, J, MACVICAR, J, NAFTALIN, N, NEUBERG, R, TAYLOR, D, LEAVER, E, TIMOTHY, I, BREESON, A, LAMB, M, VELACOTT, I, VERNER, V, HORWELL, D, LOBB, M, SELIGMAN, S, SCOTT, A, HALL, S, MACKENZIE, W, SMITH, E, VETHANAVAGAN, S, VERZIN, J, WEIR, P, WHITE, R, CLARK, H, FAWDRY, R, LYNCH, C, MCCUNE, G, BOWENSIMPKINS, P, CALVERT, J, EMERY, S, JACKSON, W, STOKES, I, WARD, A, BROWNING, A, COX, C, LITTLE, D, STIBBE, H, MCINTOSH, A, SNODGRASS, C, WAGSTAFF, T, HOWIE, P, BIBBY, J, DAVIES, W, ELLIOTT, B, SHAXTED, E, MCGARRY, J, DAW, E, BAKER, K, CLUBB, A, GOUGH, J, GRANT, M, MENON, V, OBHARI, M, OBRIEN, P, BROWN, R, RYALL, A, WALTON, S, BAKER, J, BRUCE, J, LIU, D, JOHNSON, I, TYACK, A, COWIE, D, NYSENBAUM, A, BAMFORD, P, GARRIOCH, D, HILL, J, GRANT, A, FELTON, D, HACKMAN, B, FALCONER, A, FREEMAN, F, GREENE, K, JACKSON, J, HUNTER, G, GRATTON, D, MAULIK, T, YOUSSEF, H, BANWELL, G, HARTWELL, R, WILSON, P, BOND, A, FORBESSMITH, P, BARRON, L, DAVISON, J, DUNLOP, W, LIND, T, TACCHI, D, BALFOUR, R, MUTCH, L, COLTART, T, DESWIET, M, EDMONDS, D, LOEFFLER, F, MALVERN, J, OSBOURNE, J, RODECK, C, SIMS, C, SPENCER, J, BONE, C, MACDONALD, A, DREW, N, BALLARD, R, THONET, R, HANNA, L, MORCOS, S, HOLT, E, COOPER, J, CALLEN, P, FOZZARD, C, GRUNDY, M, STANLEY, S, DANIEL, D, GOLDING, R, WIENER, J, BUCKINGHAM, M, HEARD, M, LETCHWORTH, A, BOOMLA, K, CLARK, A, GRUDZINSKAS, J, HARTGILL, J, ORAM, D, ROBSON, J, SAVAGE, W, BLUNT, V, LANE, J, OWEN, A, REDFORD, D, BEARD, R, BOSTOCK, J, MEASDAY, B, MELVILLE, H, DORNAN, J, TRAUB, A, UTIDJIAN, M, AULD, A, KRASZEWSKI, A, MACK, D, MCDOUGALL, N, MOWAT, J, DOCHERTY, P, MCKENNA, D, SMEDLEY, G, WILDE, J, SMITH, R, WATNEY, P, MCDONNELL, J, TROMAMS, P, CALDER, A, GLASIER, A, GREER, I, JOHNSTONE, F, LISTON, W, LIVINGSTONE, J, NEILSON, J, SMITH, S, WEST, C, BULLOUGH, C, JONES, A, MACKAY, G, COOPER, K, RUOSS, C, JOYCE, D, MCCOY, D, MCLEOD, F, SAVAGE, P, SMITH, P, TURNER, G, KANE, L, ROSENBERG, D, SHANNON, R, BROMHAM, D, BUCHAN, P, CROMPTON, A, JARVIS, G, LILFORD, R, MACDONALD, H, THORNTON, J, PINKER, G, BEVAN, J, FRANCIS, J, KETTLE, M, HOLMES, H, KERRWILSON, R, SUTTON, M, BEYNON, J, HOOKER, J, FERGUSSON, I, MORTON, K, TAYLOR, R, DAVIS, J, LOW, R, STEWART, J, ASHWORTH, F, SOONAWALLA, K, TEBBUTT, I, USHERWOOD, M, VOIGT, J, COHEN, S, GODFREY, K, MCNAB, G, MURRAY, B, GUDGEON, D, FOULKES, J, STANNARD, P, JAMSHIDI, R, MULHOLLAND, J, BOND, E, DUNLOP, J, FOGARTY, P, BRANT, H, LACHELIN, L, LLOYDJONES, R, SIDDLE, N, SILVERSTONE, A, STEELE, S, WARD, R, EDDIE, D, VERNONPARRY, J, CIETAK, K, KENNEDY, C, REED, M, SANTCASSIA, L, BEGG, H, FRAMPTON, J, GRIFFIN, D, LEWIS, B, NESTROP, A, SHERIDAN, R, TIPTON, R, BOBER, S, BROUGH, F, STAFFORD, J, HOUSE, M, PAWSON, M, REES, D, VENN, R, ANDERSON, T, HUGHES, J, REGINALD, P, HENSON, G, MORGAN, H, ALLEN, I, HANNAY, W, LENNOX, C, CALLENDER, R, MCLEAN, R, GOLDKRAND, J, and FIDALGO, C

Subjects
medicine.medical_specialty, Randomized controlled trial, law, business.industry, Internal medicine, medicine, General Medicine, medicine.disease, business, law.invention, Preeclampsia, Low dose aspirin
Published
2016

9. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years

Author

Duley, L, Farrell, B, Armstrong, N, Spark, P, Roberts, B, Smyth, R, Tivnan, M, Laws, A, Corfield, N, Salter, A, Thorn, L, Altman, D, Yu, L-M, Abalos, E, Carroli, B, Dellepiane, L, Duarte, M, Fernandez, H, Giordano, D, Clarke, M, Gray, A, Hey, E, Neilson, J, Simon, J, Collins, R, Karaoglou, A, Lilford, R, Moodley, J, Robson, S, Roberts, I, Rubin, P, Thornton, J, Twaddle, S, Villar, J, Walker, I, Watkins, C, Doyle, L, Bimbashi, A, Demalia, E, Gliozheni, O, Shpata, A, Karolinski, A, Lamas, M, Pesaresi, M, Wainer, V, Barbato, W, Paciocco, M, Bertin, M, Boiza, E, Castaldi, J, Partida, Y, Arias, C, Farri, M, Kerz, G, Aguirre, J, de Sagastizabal, M, Falcone, R, Morales, E, Carroli, G, Krupitzky, S, Lopez, S, Palermo, M, Varela, DM, Delprato, H, Camusso, H, Curioni, M, Ludmer, E, Brandi, R, Martin, R, Mesas, W, Taralli, R, Lezaola, M, Morosini, M, Andina, E, Bernal, L, Estiu, M, Ulens, E, de Speranza, BO, Peyrano, A, Damiano, M, Saumench, C, Horn, J, Pritchard, M, Smith-Orr, V, Wilson, M, Lawrence, A, Watson, D, Crowther, C, Paynter, J, Mannan, M, Shahidullah, M, Shamsuddin, L, Santos, CB, Freire, S, Melo, E, Cobo, E, Jaramillo, M, Cardozo, C, Fandino, N, Gaitan, H, Montano, L, Lozano, J, Rojas, M, Garcia, AB, Ramirez, AF, Miras, RG, Sampera, S, Farnot, U, Gomez, E, Rojas, G, Valdes, R, El-Kreem, HA, Al-Hussaini, T, Hammad, E, Danso, K, Kwapong, E, Ofosu-Barko, F, Jasper, MP, Peedicayil, A, Regi, A, Sharma, R, Chauhan, A, Raut, V, Udani, R, Batra, S, Muthal-Rathore, A, Ramji, S, Zutshi, V, Balakrishnan, S, Eapen, E, Koshy, G, Ambardar, B, Vadakkepat, P, Vaidya, D, Lema, V, Rijken, Y, Tadesse, E, Dada, O, Sofekun, A, Ohiaeri, C, Runsewe-Abiodun, T, Adewole, I, Adeyemo, A, Brown, B, Oladokun, R, Adewale, O, Inimgba, N, John, C, Ogu, R, Ekele, B, Isah, A, Onankpa, B, Jamelle, R, Junejo, D, Faiz, N, Gul, F, Sherin, A, Bangash, K, Mahmud, G, Masud, K, Tasneem, N, Gassama, S, Soyei, A, Agarwal, P, Rajadurai, V, Pirani, N, Delport, S, Macdonald, P, Mokhondo, R, Pattinson, R, Zondo, M, Adhikari, M, Mnguni, N, Carstens, M, Kirsten, G, Steyn, W, van Zyl, J, Helwig, A, Jacobson, S-L, Panosche, R, Hammond, E, Masanganise, L, and Colla, MTF-US

Subjects
Pediatrics, medicine.medical_specialty, Randomization, pre-eclampsia, magnesium sulphate, Population, Maternal Medicine, Placebo, law.invention, Longterm follow-up, Magnesium Sulfate, Randomized controlled trial, Interquartile range, law, Pregnancy, Risk Factors, Medicine, Humans, Maternal Health Services, education, Child, education.field_of_study, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Patient Acceptance of Health Care, medicine.disease, randomised trial, Clinical trial, Maternal Mortality, Relative risk, Anticonvulsants, Female, business, Follow-Up Studies
Abstract

Objective: The aim of this study was to assess long-term effects for women following the use of magnesium sulphate for pre-eclampsia. Design: Assessment at 2-3 years after delivery for women recruited to the Magpie Trial (recruitment in 1998-2001, ISRCTN 86938761), which compared magnesium sulphate with placebo for pre-eclampsia. Setting: Follow up after discharge from hospital at 125 centres in 19 countries across five continents. Population: A total of 7927 women were randomised at the follow-up centres. Of these women, 2544 were not included for logistic reasons and 601 excluded (109 at a centre where

Published
2006

10. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT)

Author

Thornton, J. G., Hornbuckle, J., Vail, A., Spiegelhalter, D. J., Levene, M., Van Bulck, B., Kalakoutis, G. M., Kralove, Hradec, Sak, P., Schneider, K. T.M., Karpathios, S. E., Major, T., Todros, T., Arduini, D., Tranquilli, A., Flumini, C., Tenore, A. C., Roncaglia, N., Frusca, T., Ferretti, G., Weinans, M. J.N., van Roosmalen, J., van der Slikke, J. W., van Geijn, H., Pernet, P. J.M., Wolf, H., Stigter, R. H., Wilczynski, J., Vasco, E., Abdullah, M., Novak-Antolic, Z., Danielian, P., Jenkinson, S. D., Welch, C. R., Griffin, C., Gee, H., Tuffnell, D., Cresswell, J., Tariq, T., Sengupta, B., Tydeman, G., Kumarendran, M. K., Churchill, D., Bewley, S., Fusi, L., Lindow, S. W., Johal, W., Fairlie, F. M., Neales, K., Mason, G., Scudamore, I., Konje, J., Walkinshaw, S. A., Griffiths, M., Dawson, A., Mires, G., Johanson, R., Fraser, R. B., Hendy Ibbs, P., Steel, S. A., Ramsay, M., Robins, J. B., Heard, M. J., Tonge, H. M., Manyonda, I. T., Walker, J., Maresh, M., Yoong, A., Soothill, P., Cameron, H., Byrne, D., Beattie, B., Bober, S., Lilford, Richard, and Athena Institute

Subjects
Pediatrics, medicine.medical_specialty, Time Factors, Developmental Disabilities, Pregnancy, High-Risk, Gestational Age, law.invention, Child Development, Fetal Organ Maturity, Randomized controlled trial, Obstetrics and gynaecology, SDG 3 - Good Health and Well-being, IUGR, Pregnancy, law, Humans, Medicine, Fetal Death, Fetal Growth Retardation, business.industry, Cerebral Palsy, Infant, Newborn, Gestational age, General Medicine, Odds ratio, Delivery, Obstetric, medicine.disease, Child development, Clinical trial, Child, Preschool, Gestation, Female, business, Follow-Up Studies
Abstract

Background Although delivery is widely used for preterm babies failing to thrive in utero, the effect of altering delivery timing has never been assessed in a randomised controlled trial. We aimed to compare the effect of delivering early with delaying birth for as long as possible. Methods 548 pregnant women were recruited by 69 hospitals in 13 European countries. Participants had fetal compromise between 24 and 36 weeks, an umbilical-artery doppler waveform recorded, and clinical uncertainty about whether immediate delivery was indicated. Before birth, 588 babies were randomly assigned to immediate delivery (n=296) or delayed delivery until the obstetrician was no longer uncertain (n=292). The main outcome was death or disability at or beyond 2 years of age. Disability was defined as a Griffiths developmental quotient of 70 or less or the presence of motor or perceptual severe disability. Analysis was by intention-to-treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN41358726. Findings Primary outcomes were available on 290 (98%) immediate and 283 (97%) deferred deliveries. Overall rate of death or severe disability at 2 years was 55 (19%) of 290 immediate births, and 44 (16%) of 283 delayed births. With adjustment for gestational age and umbilical-artery doppler category, the odds ratio (95% CrI) was 1·1 (0·7–1·8). Most of the observed difference was in disability in babies younger than 31 weeks of gestation at randomisation: 14 (13%) immediate versus five (5%) delayed deliveries. No important differences in the median Griffiths developmental quotient in survivors was seen. Interpretation The lack of difference in mortality suggests that obstetricians are delivering sick preterm babies at about the correct moment to minimise mortality. However, they could be delivering too early to minimise brain damage. These results do not lend support to the idea that obstetricians can deliver before terminal hypoxaemia to improve brain development.

Published
2004

11. Congenital Linear Becker’s Nevus, with Underlying Breast Hypoplasia that Spontaneously Corrected during Pregnancy: Role of Androgen Receptors

Author

Lyon Cc, SJ Felton, Thornton J, and Al-Niaimi F

Subjects
Hypertrichosis, congenital, hereditary, and neonatal diseases and abnormalities, Pathology, medicine.medical_specialty, business.industry, medicine.drug_class, Sebaceous hyperplasia, Scoliosis, medicine.disease, Antiandrogen, Androgen receptor, Breast Hypoplasia, medicine, Nevus, skin and connective tissue diseases, business, Becker's nevus
Abstract

Becker’s nevus is a pigmented cutaneous hamartoma that is normally localized to the upper torso. It is more commonly found in adolescent males and may form part of the Becker’s nevus syndrome, in association with other features which may include overlying hypertrichosis, chest wall, breast or limb hypoplasia and scoliosis. Congenital and linear lesions have been reported but are very rare. We describe here a case of a congenital, linear nevus with histological features diagnostic of a Becker’s nevus, with associated underlying breast hypoplasia. We confirm increased androgen receptors within her nevus and consequently, when our patient became pregnant, her relative antiandrogen profile enabled physiological enlargement of the previously hypoplastic breast beneath this nevus

Published
2012

12. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

Author

Boers, K. E., Vijgen, S. M., Bijlenga, D., Post, J. A., Bekedam, D. J., Kwee, A., Salm, P. C., Pampus, M. G., Spaanderman, M. E., Boer, K., Duvekot, J. J., Bremer, H. A., Hasaart, T. H., Friso Delemarre, Bloemenkamp, K. W., Meir, C. A., Willekes, C., Wijnen, E. J., Rijken, M., Le Cessie, S., Roumen, F. J., Thornton, J. G., Lith, J. M., Mol, B. W., Scherjon, S. A., Digitat, Study Group, Obstetrics and Gynaecology, ARD - Amsterdam Reproduction and Development, APH - Amsterdam Public Health, Reproductive Origins of Adult Health and Disease (ROAHD), Obstetrics and gynaecology, ICaR - Ischemia and repair, Faculteit der Geneeskunde, Obstetrie & Gynaecologie, RS: GROW - R4 - Reproductive and Perinatal Medicine, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), and RS: GROW - School for Oncology and Reproduction

Subjects
Adult, medicine.medical_specialty, CEREBRAL-PALSY, Intrauterine growth restriction, Gestational Age, law.invention, MORBIDITY, Young Adult, Randomized controlled trial, GESTATIONAL-AGE INFANTS, law, Pregnancy, medicine, Humans, Intervention trial, Labor, Induced, gestational-age infants late preterm infants fetal-growth intervention trial elective induction nulliparous women cerebral-palsy birth-weight morbidity retardation, Watchful Waiting, General Environmental Science, INTERVENTION TRIAL, Fetal Growth Retardation, Obstetrics, business.industry, Research, General Engineering, NULLIPAROUS WOMEN, Child Health, Pregnancy Outcome, Gestational age, LATE PRETERM INFANTS, General Medicine, Length of Stay, medicine.disease, BIRTH-WEIGHT, Clinical Trials (Epidemiology), Term (time), Epidemiologic Studies, Equivalence Trial, Reproductive Medicine, ELECTIVE INDUCTION, General Earth and Planetary Sciences, FETAL-GROWTH, Labor Onset, Female, business, RETARDATION, Labor onset
Abstract

Objective: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. Design: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). Setting: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008. Participants: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction. Interventions: Induction of labour or expectant monitoring. Main outcome measures: The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means. Results: 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (61%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%). Conclusions: In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth. Trial registration: International Standard Randomised Controlled Trial number ISRCTN10363217.

Published
2010

13. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

Author

Ederle, J., Dobson, J., Featherstone, R. L., Bonati, L. H., Worp, H. B., Borst, G. J., Lo, T. H., Gaines, P., Dorman, P. J., Macdonald, S., Lyrer, P. A., Hendriks, J. M., Mccollum, C., Nederkoorn, P. J., Brown, M. M., Algra, A., Bamford, J., Beard, J., Bland, M., Bradbury, A. W., Clifton, A., Hacke, W., Halliday, A., Malik, I., Mas, J. L., Mcguire, A. J., Sidhu, P., Venables, G., Bradbury, A., Collins, R., Molynewc, A., Naylor, R., Warlow, C., Ferro, J. M., Thomas, D., Coward, L., Featherstone, R. F., Tindall, H., Mccabe, D. J. H., Wallis, A., Brooks, M., Chambers, B., Chan, A., Chu, P., Clark, D., Dewey, H., Donnan, G., Fell, G., Hoare, M., Molan, M., Roberts, A., Roberts, N., Beiles, B., Bladin, C., Clifford, C., Grigg, M., New, G., Bell, R., Bower, S., Chong, W., Holt, M., Saunder, A., Than, P. G., Gett, S., Leggett, D., Mcgahan, T., Quinn, J., Ray, M., Wong, A., Woodruff, P., Foreman, R., Schultz, D., Scroop, R., Stanley, B., Allard, B., Atkinson, N., Cambell, W., Davies, S., Field, P., Milne, P., Mitchell, P., Tress, B., Yan, B., Beasley, A., Dunbabin, D., Stary, D., Walker, S., Cras, P., D Archambeau, O., Hendriks, J. M. H., Schil, P., Bosiers, M., Deloose, K., Buggenhout, E., Letter, J., Devos, V., Ghekiere, J., Vanhooren, G., Astarci, P., Hammer, F., Lacroix, V., Peters, A., Verhelst, R., Dejaegher, L., Peeters, A., Verbist, J., Blair, J. F., Caron, J. L., Daneault, M., Giroux, M. F., Guilbert, F., Lanthier, S., Lebrun, L. H., Oliva, V., Raymond, J., Roy, D., Soulez, G., Weill, A., Hill, M., Hu, W., Hudion, M., Morrish, W., Sutherland, G., Wong, J., Alback, A., Harno, H., Ijas, P., Kaste, M., Lepantalo, M., Mustanoja, S., Paananen, T., Porras, M., Puutala, J., Railo, M., Sairanen, T., Soinne, L., Vehmas, A., Vikatmaa, P., Goertler, M., Halloul, Z., Skalej, M., Brennan, P., Kelly, C., Leahy, A., Moroney, J., Thornton, J., Koelemay, M. J. W., Reekers, J. A. A., Roos, Y. B. W. E. M., Koudstaal, P. J., Pattynama, P. M. T., Lugt, A., Dijk, L. C., Sambeek, L. R. H. M., Urk, H., Verhargen, H. J. M., Bruininckx, C. M. A., Bruijn, S. F., Keunen, R., Knippenberg, B., Mosch, A., Treurniet, F., Dijk, L., Overhagen, H., Wever, J., Beer, F. C., Den Berg, J. S. P., Hasselt, B. A. A. M., Zeilstra, D. J., Boiten, J., Otterloo, J. C. A. D., Vries, A. C., Nieholt, G. J. L. A., Kallen, B. F. W., Blankensteijn, J. D., Leeuw, F. E., Kool, L. J. S., Vliet, J. A., Kort, G. A. P., Kapelle, L. J., Mali, W. P. T. M., Moll, F., Verhagen, H., Barber, P. A., Bourchier, R., Hill, A., Holden, A., Stewart, J., Bakke, S. J., Krohg-Sorensen, K., Skjelland, M., Tennoe, B., Bialek, P., Biejat, Z., Czepiel, W., Czlonkowska, A., Dowzenko, A., Jedrzejewska, J., Kobayashi, A., Lelek, M., Polanski, J., Kirbis, J., Milosevic, Z., Zvan, B., Vasco, J., Blasco, J., Chamorro, A., Macho, J., Obach, V., Riambau, V., San Roman, L., Branera, J., Canovas, D., Estela, J., Gaibar, A. G., Perendreu, J., Bjorses, K., Gottsater, A., Ivancev, K., Maetzsch, T., Sonesson, B., Berg, B., Delle, M., Formgren, J., Gillgren, P., Kall, T. B., Konrad, P., Nyman, N., Takolander, R., Andersson, T., Malmstedt, A., Soderman, M., Wahlgren, C., Wahlgren, N., Binaghi, S., Hirt, L., Michel, P., Ruchat, P., Engelter, S. T., Fluri, F., Guerke, L., Jacob, A. L., Kirsch, E., Radue, E. W., Stierli, P., Wasner, M., Wetznel, S., Bonvin, C., Kalangos, A., Lovblad, K., Murith, N., Ruefenacht, D., Sztajzel, R., Higgins, N., Kirkpatrick, P. J., Martin, P., Adam, D., Bell, J., Crowe, P., Gannon, M., Henderson, M. J., Sandler, D., Shinton, R. A., Scriven, J. M., Wilmink, T., D Souza, S., Egun, A., Guta, R., Punekar, S., Seriki, D. M., Thomson, G., Brennan, A., Enevoldson, T. P., Gilling-Smith, G., Gould, D. A., Harris, P. L., Mcwilliams, R. G., Nasser, H. C., White, R., Prakash, K. G., Serracino-Inglott, F., Subramanian, G., Smyth, J. V., Walker, M. G., Clarke, M., Davis, M., Dixit, S. A., Dolman, P., Dyker, A., Ford, G., Golkar, A., Jackson, R., Jayakrishnan, V., Lambert, D., Lees, T., Louw, S., Mendelow, A. D., Rodgers, H., Rose, J., Stansby, G., Wyatt, M., Baker, T., Baldwin, N., Jones, L., Mitchell, D., Munro, E., Thornton, M., Baker, D., Davis, N., Hamilton, G., Mccabe, D., Platts, A., Tibballs, J., Cleveland, T., Dodd, D., Lonsdale, R., Nair, R., Nassef, A., Nawaz, S., Belli, A., Cloud, G., Markus, H., Mcfarland, R., Morgan, R., Pereira, A., Thompson, A., Chataway, J., Cheshire, N., Gibbs, R., Hammady, M., Jenkins, M., Wolfe, J., Adiseshiah, M., Bishop, C., Brew, S., Brookes, J., Jager, R., Kitchen, N., Ashleigh, R., Butterfield, S., Gamble, G. E., Nasim, A., O Neill, P., Edwards, R. D., Lees, K. R., Mackay, A. J., Moss, J., Rogers, P., Developmental Genetics, International Carotid Stenting Study, ACS - Amsterdam Cardiovascular Sciences, Neurology, Surgery, Radiology and Nuclear Medicine, and ANS - Amsterdam Neuroscience

Subjects
Male, medicine.medical_specialty, SURGERY, medicine.medical_treatment, Carotid endarterectomy, 030204 cardiovascular system & hematology, Neuroinformatics [DCN 3], 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Angioplasty, medicine, Humans, Carotid Stenosis, cardiovascular diseases, ANGIOPLASTY, Stroke, Endarterectomy, Aged, Endarterectomy, Carotid, Intention-to-treat analysis, Cardiovascular diseases [NCEBP 14], business.industry, Stent, General Medicine, Interim analysis, medicine.disease, 3. Good health, Surgery, Female, Stents, Human medicine, Carotid stenting, business, 030217 neurology & neurosurgery, Angioplasty, Balloon
Abstract

Contains fulltext : 88112.pdf (Publisher’s version ) (Closed access) BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. FINDINGS: The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006). Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). INTERPRETATION: Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery. FUNDING: Medical Research Council, the Stroke Association, Sanofi-Synthelabo, European Union.

Published
2010

14. Anti-inflammatory drugs and analgesics for managing symptoms in people with cystic fibrosis-related arthritis

Author

Thornton J and Rangaraj S

Subjects
medicine.medical_specialty, medicine.drug_class, business.industry, Analgesic, Arthritis, medicine.disease, Placebo, Cystic fibrosis, Anti-inflammatory, law.invention, Randomized controlled trial, law, Anesthesia, Internal medicine, Arthropathy, medicine, Complication, business
Abstract

BACKGROUND Arthritis remains a relatively infrequent complication of cystic fibrosis, but is a cause of significant morbidity when it does occur. Two distinct types of arthritis are described in cystic fibrosis: cystic fibrosis-related arthropathy (CFA) and hypertrophic pulmonary osteoarthropathy (HPO). Management of arthritis in people with cystic fibrosis is uncertain and complex because of the underlying disease and its intense treatment. OBJECTIVES To review the effectiveness and safety of pharmacological agents for the symptomatic management of cystic fibrosis-related arthritis in adults and children with cystic fibrosis. SEARCH STRATEGY We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Date of most recent search: September 2007. SELECTION CRITERIA Randomised controlled trials which compared the efficacy and safety of anti-inflammatory and analgesic agents (e.g. non-steroidal anti-inflammatory agents, systemic corticosteroids, intra-articular corticosteroids) with each other, with no treatment or with placebo for CFA and HPO. DATA COLLECTION AND ANALYSIS No relevant studies were identified. MAIN RESULTS No studies were included in this review. AUTHORS' CONCLUSIONS Although it is generally recognised that CFA may be episodic and resolve spontaneously, treatment with analgesics and anti-inflammatory agents may be needed. While this approach may be sufficient to manage symptoms, it is disappointing that no randomised controlled trials to rigorously evaluate these agents were found, nor could the authors identify any quasi-randomised. This systematic review has identified the need for a well-designed adequately-powered randomised controlled trial to assess the efficacy and safety of pharmacological agents for the symptomatic management of cystic fibrosis-related arthritis (CFA and HPO) in adults and children with cystic fibrosis. Studies should also better define the two conditions. A study has recently been conducted in CFA and may help fill this gap when analysed and published.

Published
2008

15. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for children at 18 months

Author

Duley, L, Farrell, B, Armstrong, N, Spark, P, Roberts, B, Smyth, R, Tivnan, M, Laws, A, Corfield, N, Salter, A, Thorn, L, Altman, D, Yu, L-M, Abalos, E, Carroli, B, Dellepiane, L, Duarte, M, Fernandez, H, Giordano, D, Clarke, M, Gray, A, Hey, E, Neilson, J, Simon, J, Doyle, L, Kelly, T, Squires, J, Collins, R, Karaoglou, A, Lilford, R, Moodley, J, Robson, S, Roberts, I, Rubin, P, Thornton, J, Twaddle, S, Villar, J, Walker, I, Watkins, C, Bimbashi, A, Demalia, E, Gliozheni, O, Shpata, A, Karolinski, A, Lamas, M, Pesaresi, M, Wainer, V, Barbato, W, Paciocco, M, Bertin, M, Boiza, E, Castaldi, J, Partida, Y, Farri, M, Kerz, G, Aguirre, J, de Sagastiza, M, Falcone, R, Morales, E, Carroli, G, Krupitzky, S, Lopez, S, Palermo, M, Varela, DM, Delprato, H, Camusso, H, Curioni, M, Ludmer, E, Brandi, R, Martin, R, Mesas, W, Taralli, R, Lezaola, M, Morosini, M, Andina, E, Bernal, L, Estiu, M, Ulens, E, de Speranza, BO, Peyrano, A, Damiano, M, Saumench, C, Horn, J, Pritchard, M, Smith-Orr, V, Wilson, M, Lawrence, A, Watson, D, Crowther, C, Paynter, J, Mannan, M, Shahidullah, M, Shamsuddin, L, Barros Santos, C, Freire, S, Melo, E, Cobo, E, Jaramillo, M, Cardozo, C, Fandino, N, Gaitan, H, Montano, L, Lozano, J, Rojas, M, Breto Garcia, A, Fuentes Ramirez, A, Garcia Miras, R, Sampera, S, Farnot, U, Gomez, E, Rojas, G, Valdez, R, El-Kreem, HA, Al-Hussaini, T, Hammad, E, Danso, K, Kwapong, E, Ofosu-Barko, F, Jasper, MP, Peedicayil, A, Regi, A, Sharma, R, Chauhan, A, Raut, V, Udani, R, Batra, S, Muthal-Rathore, A, Ramji, S, Zutshi, V, Balakrishnan, S, Eapen, E, Koshy, G, Ambardar, B, Vadakkepat, P, Vaidya, D, Lema, V, Rijken, Y, Tadesse, E, Dada, O, Sofekun, A, Ohiaeri, C, Runsewe-Abiodun, T, Adewole, I, Adeyemo, A, Brown, B, Oladokun, R, Adewale, O, Inimgba, N, John, C, Ogu, R, Ekele, B, Isah, A, Onankpa, B, Jamelle, R, Junejo, D, Faiz, NR, Gul, F, Sherin, A, Bangash, K, Mahmud, G, Masud, K, Tasneem, N, Gassama, S, Soyei, A, Agarwal, P, Rajadurai, V, Hani, C, Pirani, N, Delport, S, Macdonald, P, Mokhondo, R, Pattinson, R, Zondo, M, Adhikari, M, Mnguni, N, Carstens, M, Kirsten, G, Steyn, W, van Zyl, J, Helwig, A, Jacobson, S-L, Panosche, R, Hammond, E, Masanganise, L, and Collabor, MTFS

Subjects
Pediatrics, medicine.medical_specialty, pre-eclampsia, magnesium sulphate, Maternal Medicine, Placebo, Preeclampsia, law.invention, Longterm follow-up, Disability Evaluation, Magnesium Sulfate, Randomized controlled trial, law, Pregnancy, medicine, Humans, reproductive and urinary physiology, Cause of death, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Infant, medicine.disease, randomised trial, female genital diseases and pregnancy complications, Disabled Children, Clinical trial, In utero, Prenatal Exposure Delayed Effects, Sensation Disorders, Anticonvulsants, Female, Nervous System Diseases, business
Abstract

Objective To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. Design Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998–2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. Setting Follow-up of children born at 125 centres in 19 countries across five continents. Population A total of 6922 children were born to women randomised before delivery at follow-up centres. Of these, 2271 were not included for logistic reasons and 168 were excluded (101 at a centre where

Published
2007

16. [Untitled]

Author

Thornton J and Moore M

Subjects
Anesthesiology and Pain Medicine, business.industry, Obstetrics and Gynecology, Medicine, Medical emergency, business, medicine.disease
Published
1995

18. Leadership traits that work worldwide

Author

Thornton, J. Scott

Subjects
Associations, institutions, etc. -- Foreign operations, Cross-cultural orientation -- Usage, Executive ability -- International aspects, Business, Business, general
Published
1990

19. PENETRATING TRAUMA OF THE NECK

Author

Robert J. Lowe, John D. Saletta, Gerald S. Moss, Delk S, Thornton J, and Lim Lt

Subjects
Adult, Male, medicine.medical_specialty, Resuscitation, Adolescent, Wounds, Penetrating, Wounds, Stab, Diagnostic evaluation, Critical Care and Intensive Care Medicine, Neck Injuries, Neck exploration, medicine, Humans, Brachiocephalic Trunk, medicine.diagnostic_test, business.industry, Mortality rate, General surgery, Incidence (epidemiology), Middle Aged, medicine.disease, Endoscopy, Radiography, Arteriovenous Fistula, Wounds and Injuries, Female, Wounds, Gunshot, Surgery, business, Neck, Penetrating trauma
Abstract

Two hundred forty-six patients admitted to the Trauma Unit of Cook County Hospital with penetrating neck wounds have been reviewed. A policy of mandatory neck exploration combined with a systematic approach to resuscitation and a diagnostic evaluation including neck and chest X-rays, endoscopy, and arteriography has been employed. The study has revealed a high incidence of negative neck explorations (63%) but minimal morbidity (less than 1%), no mortality, and a brief duration of hospitalization in the negative exploration group. Patients with positive explorations had an 8% morbidity and a 9% mortality rate. In addition, 13 of the patients with positive explorations had clinically negative wounds which might have been overlooked if selective management had been utilized in this series. We conclude that a policy of mandatory neck exploration is justified and advisable for patients sustaining penetrating neck injuries.

Published
1976

20. Financial Management of Computing

Author

Thornton, J.

Subjects
Cost (Economics), Computers, Public finance -- Accounting and auditing, Banking, finance and accounting industries, Business
Published
1982

22. METALS: RECESSION ROCKS LONG-TERM TRENDS

Author

THORNTON, J.

Subjects
Metals -- Marketing, Distribution of goods -- Marketing, Markets (Economics) -- Evaluation, Advertising, marketing and public relations, Business, Business, international
Published
1980

23. HONING SALES TECHNIQUES

Author

THORNTON, J.

Subjects
SALES -- Marketing, Metals -- Marketing, Advertising, marketing and public relations, Business, Business, international
Published
1980

24. Evaluation of a psychiatric clerkship by videotape

Author

Wachtel A, Thornton J, and Meyerson At

Subjects
Program evaluation, Psychiatry, medicine.medical_specialty, Medical education, Faculty, Medical, Students, Medical, Relative efficacy, business.industry, Clinical judgement, education, Videotape Recording, Objective assessment, Psychiatry and Mental health, Evaluation Studies as Topic, Medicine, Humans, Clinical Competence, Clinical competence, business, Grading (education), Clinical psychology
Abstract

The authors used a videotape-based objective examination ingeneral psychiatry to assess the clinical competence of medical students who had completed their third-year clerkship. The test has been shown to be a reliable, valid measure of clinical competence. Subjective faculty grading related positively to test scores. Students on one ward had significantly lower overall test scores, with particularly low scores on clinical judgement questions. However, faculty grades for these students were not significantly different. This suggests that the faculty was unable to assess the relative efficacy of its own teaching. The test can provide objective assessment of student clinical competence and is a means of program evaluation.

Published
1977

25. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis

Author

Agata Majewska, Jessica A Marathe, Jenny Chambers, Romana Brun-Furrer, Ugo Indraccolo, Yue Cui, Stefan C. Kane, George Attilakos, Maria C. Estiú, L.F. Audris Wong, Andrew Shennan, Rachel M. Tribe, Michael J. Peek, Richard H. Lee, Keren Zloto, Jim G Thornton, Hanns-Ulrich Marschall, Tharni Vasavan, Yoav Yinon, Yannick Bacq, Caroline Ovadia, Berrin Günaydin, Xiaohua Liu, Yayi Hu, Catherine Williamson, Jūratė Kondrackienė, Ayse Gul Kebapcilar, Martijn A. Oudijk, Qianwen Zhang, Kasia Maksym, Victoria Geenes, William M. Hague, Alexander Juusela, Min Ding, Levent Kebapcilar, Valeria Tripodi, Deniz Oztekin, Kajol Patel, Rocio I.R. Macias, Nicholas A. Williamson, Christian Haslinger, Monika Grymowicz, Linoy Batsry, Fergus W. Gardiner, Naciye Turk Ozterlemez, Riza Madazli, Lucy C Chappell, Peter H. Dixon, Paul T. Seed, Anna Locatelli, Kelsey Broom, Maria P.H. Koster, Laura N. Bull, Jenna Sajous, Adam Morton, Francesco Azzaroli, Katherine Kohari, Ovadia C., Sajous J., Seed P.T., Patel K., Williamson N.J., Attilakos G., Azzaroli F., Bacq Y., Batsry L., Broom K., Brun-Furrer R., Bull L., Chambers J., Cui Y., Ding M., Dixon P.H., Estiu M.C., Gardiner F.W., Geenes V., Grymowicz M., Gunaydin B., Hague W.M., Haslinger C., Hu Y., Indraccolo U., Juusela A., Kane S.C., Kebapcilar A., Kebapcilar L., Kohari K., Kondrackiene J., Koster M.P.H., Lee R.H., Liu X., Locatelli A., Macias R.I.R., Madazli R., Majewska A., Maksym K., Marathe J.A., Morton A., Oudijk M.A., Oztekin D., Peek M.J., Shennan A.H., Tribe R.M., Tripodi V., Turk Ozterlemez N., Vasavan T., Wong L.F.A., Yinon Y., Zhang Q., Zloto K., Marschall H.-U., Thornton J., Chappell L.C., Williamson C., Obstetrics and Gynaecology, ARD - Amsterdam Reproduction and Development, Ovadia, C, Sajous, J, Seed, P, Patel, K, Williamson, N, Attilakos, G, Azzaroli, F, Bacq, Y, Batsry, L, Broom, K, Brun-Furrer, R, Bull, L, Chambers, J, Cui, Y, Ding, M, Dixon, P, Estiu, M, Gardiner, F, Geenes, V, Grymowicz, M, Gunaydin, B, Hague, W, Haslinger, C, Hu, Y, Indraccolo, U, Juusela, A, Kane, S, Kebapcilar, A, Kebapcilar, L, Kohari, K, Kondrackiene, J, Koster, M, Lee, R, Liu, X, Locatelli, A, Macias, R, Madazli, R, Majewska, A, Maksym, K, Marathe, J, Morton, A, Oudijk, M, Oztekin, D, Peek, M, Shennan, A, Tribe, R, Tripodi, V, Turk Ozterlemez, N, Vasavan, T, Wong, L, Yinon, Y, Zhang, Q, Zloto, K, Marschall, H, Thornton, J, Chappell, L, Williamson, C, Obstetrics & Gynecology, and Amsterdam Reproduction & Development (AR&D)

Subjects
Cholagogues and Choleretics, medicine.medical_specialty, medicine.drug_class, Cholestasis, Intrahepatic, 03 medical and health sciences, 0302 clinical medicine, Cholestasis, Pregnancy, Internal medicine, Cholestasis of pregnancy, Humans, Medicine, Hepatology, Bile acid, business.industry, Obstetrics, Individual participant data, Gastroenterology, Obstetrics and Gynecology, General Medicine, Odds ratio, medicine.disease, Ursodeoxycholic acid, Pregnancy Complications, 030220 oncology & carcinogenesis, Meta-analysis, Female, 030211 gastroenterology & hepatology, stillbirth, Ursodeoxycholic acid, pregnancy, intrahepatic cholestasis of pregnancy, business, medicine.drug, Cohort study
Abstract

Background: Ursodeoxycholic acid is commonly used to treat intrahepatic cholestasis of pregnancy, yet its largest trial detected minimal benefit for a composite outcome (stillbirth, preterm birth, and neonatal unit admission). We aimed to examine whether ursodeoxycholic acid affects specific adverse perinatal outcomes. Methods: In this systematic review and individual participant data meta-analysis, we searched PubMed, Web of Science, Embase, MEDLINE, CINAHL, Global Health, MIDIRS, and Cochrane without language restrictions for relevant articles published between database inception, and Jan 1, 2020, using search terms referencing intrahepatic cholestasis of pregnancy, ursodeoxycholic acid, and perinatal outcomes. Eligible studies had 30 or more study participants and reported on at least one individual with intrahepatic cholestasis of pregnancy and bile acid concentrations of 40 μmol/L or more. We also included two unpublished cohort studies. Individual participant data were collected from the authors of selected studies. The primary outcome was the prevalence of stillbirth, for which we anticipated there would be insufficient data to achieve statistical power. Therefore, we included a composite of stillbirth and preterm birth as a main secondary outcome. A mixed-effects meta-analysis was done using multi-level modelling and adjusting for bile acid concentration, parity, and multifetal pregnancy. Individual participant data analyses were done for all studies and in different subgroups, which were produced by limiting analyses to randomised controlled trials only, singleton pregnancies only, or two-arm studies only. This study is registered with PROSPERO, CRD42019131495. Findings: The authors of the 85 studies fulfilling our inclusion criteria were contacted. Individual participant data from 6974 women in 34 studies were included in the meta-analysis, of whom 4726 (67·8%) took ursodeoxycholic acid. Stillbirth occurred in 35 (0·7%) of 5097 fetuses among women with intrahepatic cholestasis of pregnancy treated with ursodeoxycholic acid and in 12 (0·6%) of 2038 fetuses among women with intrahepatic cholestasis of pregnancy not treated with ursodeoxycholic acid (adjusted odds ratio [aOR] 1·04, 95% CI 0·35–3·07; p=0·95). Ursodeoxycholic acid treatment also had no effect on the prevalence of stillbirth when considering only randomised controlled trials (aOR 0·29, 95% CI 0·04–2·42; p=0·25). Ursodeoxycholic acid treatment had no effect on the prevalence of the composite outcome in all studies (aOR 1·28, 95% CI 0·86–1·91; p=0·22), but was associated with a reduced composite outcome when considering only randomised controlled trials (0·60, 0·39–0·91; p=0·016). Interpretation: Ursodeoxycholic acid treatment had no significant effect on the prevalence of stillbirth in women with intrahepatic cholestasis of pregnancy, but our analysis was probably limited by the low overall event rate. However, when considering only randomised controlled trials, ursodeoxycholic acid was associated with a reduction in stillbirth in combination with preterm birth, providing evidence for the clinical benefit of antenatal ursodeoxycholic acid treatment. Funding: Tommy's, the Wellcome Trust, ICP Support, and the National Institute for Health Research.

Published
2021

26. European Banking Union and bank risk disclosure: the effects of the Single Supervisory Mechanism

Author

Enzo Scannella, Salvatore Polizzi, John Thornton, Yener Altunbas, Altunbas Y., Polizzi S., Scannella E., and Thornton J.

Subjects
Hardware_MEMORYSTRUCTURES, 050208 finance, Natural experiment, Risk disclosure, Settore SECS-P/11 - Economia Degli Intermediari Finanziari, 05 social sciences, European central bank, Principal–agent problem, Financial system, Banking union, General Business, Management and Accounting, Principal-agent problem, Single supervisory mechanism, Corporate finance, Bank risk, Banks, Accounting, 0502 economics and business, Business, Information flow (information theory), 050207 economics, Finance
Abstract

This paper provides evidence on the impact of European Banking Union (BU) and the associated Single Supervisory Mechanism (SSM) on the risk disclosure practices of European banks. The onset of BU and the associated rules are considered as an exogenous shock that provides the setting for a natural experiment to analyze the effects of the new supervisory arrangements on bank risk disclosure practices. A Difference-in-Differences approach is adopted, building evidence from the disclosure practices of systemically important banks supervised by the European Central Bank (ECB) and other banks supervised by national regulators over the period 2012–2017. The main findings are that bank risk disclosure increased overall following BU but there was a weakening of disclosure by SSM-supervised banks relative to banks supervised by national authorities. We also find that the overall positive effect of the BU on bank disclosure is stronger for less profitable banks and in the most troubled economies of the Eurozone (GIPSI countries), while the negative effect on centrally supervised banks is stronger if bank CEOs act also as chairmen (CEO duality). We interpret these findings in light of the fact that the new institutional arrangements for bank supervision under which the ECB relies on local supervisors to collect the information necessary to act gives rise to inefficiencies with respect to the speed and completeness of the information flow between SSM supervised banks and the ECB, which are reflected in bank disclosure practices.

Published
2021

27. FLAIR-only joint volumetric analysis of brain lesions and atrophy in clinically isolated syndrome (CIS) suggestive of multiple sclerosis

Author

Sara Collorone, Marloes Hagens, Sjoerd B. Vos, Ferran Prados, Carole H. Sudre, John S. Thornton, Frederik Barkhof, Olivia Goodkin, Hugh G. Pemberton, Tarek A. Yousry, Manuel Jorge Cardoso, Goodkin, O., Prados, F., Vos, S. B., Pemberton, H., Collorone, S., Hagens, M. H. J., Cardoso, M. J., Yousry, T. A., Thornton, J. S., Sudre, C. H., Barkhof, F., MAGNIMS study, Group, Filippi, M, Rocca, M. A., Neurology, Radiology and nuclear medicine, Amsterdam Neuroscience - Brain Imaging, and Amsterdam Neuroscience - Neuroinfection & -inflammation

Subjects
medicine.medical_specialty, Cognitive Neuroscience, Fluid-attenuated inversion recovery, lcsh:Computer applications to medicine. Medical informatics, lcsh:RC346-429, 050105 experimental psychology, White matter, Lesion, Multiple sclerosis, 03 medical and health sciences, 0302 clinical medicine, Magnetic resonance imaging, medicine, Humans, Brain segmentation, 0501 psychology and cognitive sciences, Radiology, Nuclear Medicine and imaging, Gray Matter, lcsh:Neurology. Diseases of the nervous system, Clinically isolated syndrome, medicine.diagnostic_test, business.industry, 05 social sciences, Neurodegenerative diseases, Leukoaraiosis, Brain, Regular Article, Hyperintensity, Demyelinating diseases, medicine.anatomical_structure, Neurology, Brain size, lcsh:R858-859.7, Neurology (clinical), Radiology, Atrophy, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract

Background MRI assessment in multiple sclerosis (MS) focuses on the presence of typical white matter (WM) lesions. Neurodegeneration characterised by brain atrophy is recognised in the research field as an important prognostic factor. It is not routinely reported clinically, in part due to difficulty in achieving reproducible measurements. Automated MRI quantification of WM lesions and brain volume could provide important clinical monitoring data. In general, lesion quantification relies on both T1 and FLAIR input images, while tissue volumetry relies on T1. However, T1-weighted scans are not routinely included in the clinical MS protocol, limiting the utility of automated quantification. Objectives We address an aspect of this important translational challenge by assessing the performance of FLAIR-only lesion and brain segmentation, against a conventional approach requiring multi-contrast acquisition. We explore whether FLAIR-only grey matter (GM) segmentation yields more variability in performance compared with two-channel segmentation; whether this is related to field strength; and whether the results meet a level of clinical acceptability demonstrated by the ability to reproduce established biological associations. Methods We used a multicentre dataset of subjects with a CIS suggestive of MS scanned at 1.5T and 3T in the same week. WM lesions were manually segmented by two raters, ‘manual 1′ guided by consensus reading of CIS-specific lesions and ‘manual 2′ by any WM hyperintensity. An existing brain segmentation method was adapted for FLAIR-only input. Automated segmentation of WM hyperintensity and brain volumes were performed with conventional (T1/T1 + FLAIR) and FLAIR-only methods. Results WM lesion volumes were comparable at 1.5T between ‘manual 2′ and FLAIR-only methods and at 3T between ‘manual 2′, T1 + FLAIR and FLAIR-only methods. For cortical GM volume, linear regression measures between conventional and FLAIR-only segmentation were high (1.5T: α = 1.029, R2 = 0.997, standard error (SE) = 0.007; 3T: α = 1.019, R2 = 0.998, SE = 0.006). Age-associated change in cortical GM volume was a significant covariate in both T1 (p = 0.001) and FLAIR-only (p = 0.005) methods, confirming the expected relationship between age and GM volume for FLAIR-only segmentations. Conclusions FLAIR-only automated segmentation of WM lesions and brain volumes were consistent with results obtained through conventional methods and had the ability to demonstrate biological effects in our study population. Imaging protocol harmonisation and validation with other MS phenotypes could facilitate the integration of automated WM lesion volume and brain atrophy analysis as clinical tools in radiological MS reporting.

Published
2021

28. Relationship between foot posture index and weight bearing computed tomography 3D biometrics to define foot alignment

Author

Olatunbosun Buraimoh, Shelain Patel, Dishan Singh, Matthew Welck, James Thornton, Nicholas Cullen, Alessio Bernasconi, Patel, S., Bernasconi, A., Thornton, J., Buraimoh, O., Cullen, N. P., Welck, M. J., and Singh, D.

Subjects
Adult, Male, Biometry, Biometrics, Adolescent, Population, Posture, Biophysics, Computed tomography, medicine.disease_cause, Foot posture index, Weight-bearing, Weight-Bearing, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Medicine, Humans, Orthopedics and Sports Medicine, education, Reliability (statistics), Aged, Orthodontics, education.field_of_study, Biometric, Weight bearing CT, biology, medicine.diagnostic_test, business.industry, Foot, Rehabilitation, Reproducibility of Results, 030229 sport sciences, Middle Aged, biology.organism_classification, Valgus, medicine.anatomical_structure, Female, Ankle, business, Tomography, X-Ray Computed, 030217 neurology & neurosurgery, Foot (unit)
Abstract

Background The Foot Posture Index (FPI) was originally validated only against two dimensional radiographic imaging at the time of its inception since weight bearing three dimensional (3D) imaging did not exist. This technology is now widely available but it is not known if the FPI will continue to correlate well against it. Research question: How does the clinical assessment tool of FPI correlate against 3D biometrics of foot alignment assessed on weight bearing computerised tomography (WBCT)? Methods The FPI and 3D biometrics of 66 feet in 33 patients presenting to a single foot and ankle unit were assessed by two observers independently. All measurements were assessed for intra-rater and inter-rater reliability, and the association between the clinically assessed FPI and radiologically assessed 3D biometrics was identified. Results The FPI demonstrated excellent intra-rater and good inter-rater reliability. All 3D biometric measures demonstrated excellent intra-rater and inter-rater reliability. A strong and significant correlation was identified between the FPI and 3D biometrics overall although subgroup analysis revealed the strength of association dropped when the hindfoot had a valgus alignment. Significance This study confirmed that the FPI is a valid tool for assessing foot position. However, correlation between the FPI and 3D biometrics fell in the valgus aligned hindfoot so caution must be used when the FPI is used for assessment in this population.

Published
2020

29. Association of Adverse Perinatal Outcomes of Intrahepatic Cholestasis of Pregnancy With Biochemical Markers: Results of Aggregate and Individual Patient Data Meta-Analyses

Author

Yannick Bacq, Jenny Chambers, Martijn A. Oudijk, Monika Grymowicz, William M. Hague, Yayi Hu, Romana Brun-Furrer, Victoria Geenes, Valeria Tripodi, Lucy C Chappell, Paul T. Seed, Berrin Günaydin, Limas Kupčinskas, Richard H. Lee, Rachel M. Tribe, Hanns-Ulrich Marschall, Catherine Williamson, Ayse Gul Kebapcilar, Anna Locatelli, Eli Rimon, Caroline Ovadia, Cigdem Yayla Abide, Ilter Yenidede, Nuray Bozkurt, Aneta Kowalska-Kańka, Chiara di Illio, Jim G Thornton, Katherine Kohari, Rocio I.R. Macias, Maria C. Estiú, Dan Shan, Tetsuya Kawakita, Levent Kebapcilar, Christian Haslinger, Yong Shao, Maria P.H. Koster, Laura N. Bull, Jurate Kondrackiene, Alexandros Sklavounos, Yael Raz, Selçuk Üniversitesi, Tıp Fakültesi, Cerrahi Tıp Bilimleri Bölümü, Kebapcılar, Ayse Gül, Kebapcılar, Levent, Obstetrics & Gynecology, Ovadia, C, Seed, P, Sklavounos, A, Geenes, V, Di Illio, C, Chambers, J, Kohari, K, Bacq, Y, Bozkurt, N, Brun-Furrer, R, Bull, L, Estiú, M, Grymowicz, M, Gunaydin, B, Hague, W, Haslinger, C, Hu, Y, Kawakita, T, Kebapcilar, A, Kebapcilar, L, Kondrackienė, J, Koster, M, Kowalska-Kańka, A, Kupčinskas, L, Lee, R, Locatelli, A, Macias, R, Marschall, H, Oudijk, M, Raz, Y, Rimon, E, Shan, D, Shao, Y, Tribe, R, Tripodi, V, Yayla Abide, C, Yenidede, I, Thornton, J, Chappell, L, Williamson, C, Obstetrics and Gynaecology, ARD - Amsterdam Reproduction and Development, and Amsterdam Reproduction & Development (AR&D)

Subjects
Perinatal Death, MED/40 - GINECOLOGIA E OSTETRICIA, Medical and Health Sciences, Cohort Studies, 0302 clinical medicine, Risk Factors, Pregnancy, 030202 anesthesiology, Intrahepatic cholestasis of pregnancy, INTRAHEPATIC CHOLESTASIS OF PREGNANCY, Biochemical markers, Randomized Controlled Trials as Topic, Intrahepatic, 0303 health sciences, Cholestasis, 030219 obstetrics & reproductive medicine, Obstetrics and Gynecology, Alanine Transaminase, General Medicine, Stillbirth, 3. Good health, Premature Birth, Female, 030211 gastroenterology & hepatology, purl.org/becyt/ford/3 [https], stillbirth, pregnancy, Cholestasis of pregnancy, medicine.medical_specialty, cholestasis, pregnancy, intrauterine death, bile acids, Cholestasis, Intrahepatic, Article, Bile Acids and Salts, purl.org/becyt/ford/3.3 [https], 03 medical and health sciences, General & Internal Medicine, Internal medicine, medicine, Humans, Aspartate Aminotransferases, Association (psychology), 030304 developmental biology, business.industry, Parturition, Infant, Bilirubin, Patient data, Newborn, medicine.disease, Pregnancy Complications, ROC Curve, Case-Control Studies, BILE ACIDS, business, Biomarkers
Abstract

WOS: 000477016300004, Intrahepatic cholestasis of pregnancy (ICP) affects less than 0.1% to 0.2% of pregnant women. It is diagnosed in women with gestational pruritus and increased serum bile acids and can be complicated by preterm labor, fetal asphyxia, meconium-stained amniotic fluid, and stillbirth.

Published
2020

30. 3D Biometrics for Hindfoot Alignment Using Weightbearing CT

Author

Andy Goldberg, James Thornton, Matthew Welck, Nicholas Cullen, Alessio Bernasconi, Dishan Singh, Francois Lintz, Lintz, F, Welck, M, Bernasconi, A, Thornton, J, Cullen, Np, Singh, D, and Goldberg, A.

Subjects
Interobserver reliability, Biometrics, Radiography, Pilot Projects, Computed tomography, Weight-Bearing, 03 medical and health sciences, 0302 clinical medicine, Humans, Medicine, Orthopedics and Sports Medicine, Retrospective Studies, Orthodontics, 030222 orthopedics, medicine.diagnostic_test, biology, Foot, business.industry, Reproducibility of Results, 030229 sport sciences, Anatomy, biology.organism_classification, Calcaneus, Valgus, medicine.anatomical_structure, Surgery, Ankle, Tomography, X-Ray Computed, business, Ankle Joint, 3d coordinates
Abstract

Background: Hindfoot alignment on 2D radiographs can present anatomical and operator-related bias. In this study, software designed for weightbearing computed tomography (WBCT) was used to calculate a new 3D biometric tool: the Foot and Ankle Offset (FAO). We described the distribution of FAO in a series of data sets from clinically normal, varus, and valgus cases, hypothesizing that FAO values would be significantly different in the 3 groups. Methods: In this retrospective cohort study, 135 data sets (57 normal, 38 varus, 40 valgus) from WBCT (PedCAT; CurveBeam LLC, Warrington, PA) were obtained from a specialized foot and ankle unit. 3D coordinates of specific anatomical landmarks (weightbearing points of the calcaneus, of the first and fifth metatarsal heads and the highest and centermost point on the talar dome) were collected. These data were processed with the TALAS system (CurveBeam), which resulted in an FAO value for each case. Intraobserver and interobserver reliability were also assessed. Results: In normal cases, the mean value for FAO was 2.3% ± 2.9%, whereas in varus and valgus cases, the mean was −11.6% ± 6.9% and 11.4% ± 5.7%, respectively, with a statistically significant difference among groups ( P < .001). The distribution of the normal population was Gaussian. The inter- and intraobserver reliability were 0.99 +/- 0.00 and 0.97 +/-0.02 Conclusions: This pilot study suggests that the FAO is an efficient tool for measuring hindfoot alignment using WBCT. Previously published research in this field has looked at WBCT by adapting 2D biometrics. The present study introduces the concept of 3D biometrics and describes an efficient, semiautomatic tool for measuring hindfoot alignment. Level of Evidence: Level III, retrospective comparative study.

Published
2017

31. Is middle cerebral artery Doppler related to neonatal and 2-year infant outcome in early fetal growth restriction?

Author

Baskaran Thilaganathan, T. Diehl, A. G. van Wassenaer-Leemhuis, A. Aktas, A T Papageorghiou, Caterina M. Bilardo, Enrico Ferrazzi, R. Chaoui, G. H. A. Visser, Herbert Valensise, J. A. M. van der Post, Jan B. Derks, G. Oggè, J. van Eyck, Neil Marlow, I.K.M. Reiss, Wessel Ganzevoort, Ktm Schneider, M Oberto, A. Skabar, Raffaele Napolitano, U. Maurer-Fellbaum, H. Missfelder-Lobos, John Kingdom, G. Mansi, S. Borgione, Federico Prefumo, Anke Diemert, Tamara Stampalija, E. Lopriore, Gianpaolo Maso, Karel Marsal, Tiziana Frusca, L.S. Scheepers, F. Raimondi, Dietmar Schlembach, Adriana Valcamonico, N. Mensing van Charante, Christoph Lees, Silvia M. Lobmaier, Christoph Brezinka, L. Preston, S. Mulder-de Tollenaer, Pasquale Martinelli, Jim G Thornton, Marc E. A. Spaanderman, J.J. Duvekot, Nicola Fratelli, I.C. van Haastert, N. Weisglas-Kuperus, Dick Oepkes, Kurt Hecher, Hans Wolf, Tullia Todros, E. Ostermayer, Birgit Arabin, A. Zimmermann, Jérôme Cornette, P. Martelli, Other departments, ARD - Amsterdam Reproduction and Development, APH - Quality of Care, Obstetrics and Gynaecology, Other Research, Neonatology, APH - Digital Health, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Stampalija, Tamara, Arabin, Birgit, Wolf, Han, Bilardo, Caterina M., Lees, Christoph, Brezinka, C., Derks, J. B., Diemert, A., Duvekot, J. J., Ferrazzi, E., Frusca, T., Ganzevoort, W., Hecher, K., Kingdom, J., Marlow, N., Marsal, K., Martinelli, P., Ostermayer, E., Papageorghiou, A. T., Schlembach, D., Schneider, K. T. M., Thilaganathan, B., Thornton, J., Todros, T., Valcamonico, A., Valensise, H., van Wassenaer-Leemhuis, A., Visser, G. H. A., Aktas, A., Borgione, S., Chaoui, R., Cornette, J. M. J., Diehl, T., van Eyck, J., Fratelli, N., van Haastert, I. C., Lobmaier, S., Lopriore, E., Missfelder-Lobos, H., Mansi, G., Martelli, P., Maso, G., Maurer-Fellbaum, U., Mensing van Charante, N., Mulder-de Tollenaer, S., Napolitano, R., Oberto, M., Oepkes, D., Ogge, G., van der Post, J. A. M., Prefumo, F., Preston, L., Raimondi, F., Reiss, I. K. M., Scheepers, L. S., Skabar, A., Spaanderman, M., Weisglas-Kuperus, N., Zimmermann, A., Bilardo, Caterina M, Raimondi, Francesco, Reproductive Origins of Adult Health and Disease (ROAHD), and Amsterdam Reproduction & Development (AR&D)

Subjects
Middle Cerebral Artery, PREDICTION, Intrauterine growth restriction, Umbilical Arteries, 0302 clinical medicine, Child Development, cerebroplacental ratio, Doppler velocimetry, intrauterine growth restriction, middle cerebral artery, neonatal, umbilicocerebral ratio, Pregnancy, RESISTANCE INDEX RATIO, Obstetrics and Gynaecology, FOR-GESTATIONAL-AGE, 1114 Paediatrics And Reproductive Medicine, Birth Weight, Prenatal, Cardiotocography, 030212 general & internal medicine, Prospective Studies, Child, Ultrasonography, RISK, 030219 obstetrics & reproductive medicine, Fetal Growth Retardation, medicine.diagnostic_test, Obstetrics, Doppler, Gestational age, Obstetrics and Gynecology, Settore MED/40, Child, Preschool, Pulsatile Flow, Middle cerebral artery, BLOOD-FLOW PARAMETERS, Female, Delivery, Ductus venosus, Human, medicine.medical_specialty, Delivery, Obstetric, Gestational Age, Humans, Ultrasonography, Doppler, Ultrasonography, Prenatal, Preschool, Obstetric, 03 medical and health sciences, PULSATILITY INDEX, FETUSES, medicine.artery, SURVEILLANCE, medicine, Journal Article, Obstetrics & Reproductive Medicine, business.industry, Umbilical artery, Odds ratio, medicine.disease, Confidence interval, Prospective Studie, Umbilical Arterie, WEIGHT, business
Abstract

BACKGROUND: Reduced fetal middle cerebral artery Doppler impedance is associated with hypoxemia in fetal growth restriction. It remains unclear as to whether this finding could be useful in timing delivery, especially in the third trimester. In this regard there is a paucity of evidence from prospective studies.OBJECTIVES: The aim of this study was to determine whether there is an association between middle cerebral artery Doppler impedance and its ratio with the umbilical artery in relation to neonatal and 2 year infant outcome in early fetal growth restriction (26(+0) -31(+6) weeks of gestation). Additionally we sought to explore which ratio is more informative for clinical use.STUDY DESIGN: This is a secondary analysis from the Trial of Randomized Umbilical and Fetal Flow in Europe, a prospective, multicenter, randomized management study on different antenatal monitoring strategies (ductus venosus Doppler changes and computerized cardiotocography short-term variation) in fetal growth restriction diagnosed between 26(+0) and 31(+6) weeks. We analyzed women with middle cerebral artery Doppler measurement at study entry and within 1 week before delivery and with complete postnatal follow-up (374 of 503). The primary outcome was survival without neurodevelopmental impairment at 2 years corrected for prematurity. Neonatal outcome was defined as survival until first discharge home without severe neonatal morbidity. Z-scores were calculated for middle cerebral artery pulsatility index and both umbilicocerebral and cerebroplacental ratios. Odds ratios of Doppler parameter Z-scores for neonatal and 2 year infant outcome were calculated by multivariable logistic regression analysis adjusted for gestational age and birthweight p50 ratio.RESULTS: Higher middle cerebral artery pulsatility index at inclusion but not within 1 week before delivery was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52). Middle cerebral artery pulsatility index Z-score and umbilicocerebral ratio Z-score at inclusion were associated with 2 year survival with normal neurodevelopmental outcome (odds ratio, 1.33; 95% confidence interval, 1.03-1.72, and odds ratio, 0.88; 95% confidence interval, 0.78-0.99, respectively) as were gestation at delivery and birthweight p50 ratio (odds ratio, 1.41; 95% confidence interval, 1.20-1.66, and odds ratio, 1.86; 95% confidence interval, 1.33-2.60, respectively). When comparing cerebroplacental ratio against umbilicocerebral ratio, the incremental range of the cerebroplacental ratio tended toward zero, whereas the umbilicocerebral ratio tended toward infinity as the values became more abnormal.CONCLUSION: In a monitoring protocol based on ductus venosus and cardiotocography in early fetal growth restriction (26(+0) -31(+6) weeks of gestation), the impact of middle cerebral artery Doppler and its ratios on outcome is modest and less marked than birthweight and delivery gestation. It is unlikely that middle cerebral artery Doppler and its ratios are informative in optimizing the timing of delivery in fetal growth restriction before 32 weeks of gestation. The umbilicocerebral ratio allows for a better differentiation in the abnormal range than the cerebroplacental ratio.

Published
2017

32. Short-term adaptation to a simple motor task: A physiological process preserved in multiple sclerosis

Author

S. C. Manson, Xavier Montalban, Ludwig Kappos, F. Manfredonia, T Korteweg, Christian F. Beckmann, Frederik Barkhof, Karl J. Friston, S. Marino, Heidi Johansen-Berg, Ana Rovira, N. De Stefano, Olga Ciccarelli, Jochen G. Hirsch, Maria A. Rocca, Stefan Ropele, Paul M. Matthews, Massimo Filippi, John S. Thornton, Laura Mancini, Tarek A. Yousry, Christian Enzinger, Franz Fazekas, Federica Agosta, Chris H. Polman, Jacqueline Palace, Alan J. Thompson, Christiane Wegner, Achim Gass, Radiology and nuclear medicine, Neurology, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases, Mancini, L, Ciccarelli, O, Manfredonia, F, Thornton, J, Agosta, F, Barkhof, F, Beckmann, C, De Stefano, N, Enzinger, C, Fazekas, F, Filippi, M, Gass, A, Hirsch, Jg, Johansen-Berg, H, Kappos, L, Korteweg, T, Manson, Sc, Marino, S, Matthews, Pm, Montalban, X, Palace, J, Polman, C, Rocca, M, Ropele, S, Rovira, A, Wegner, C, Friston, K, Thompson, A, and Yousry, T

Subjects
Adult, Male, medicine.medical_specialty, Cerebellum, Movement, Cognitive Neuroscience, Adaptation (eye), Audiology, Hand movement, Task (project management), Multiple sclerosis, Young Adult, Text mining, Multi-centre, Cortex (anatomy), Task Performance and Analysis, medicine, Humans, Adaptation, Cued speech, Brain Mapping, Supplementary motor area, business.industry, fMRI, Brain, Middle Aged, Evoked Potentials, Motor, Hand, medicine.disease, Adaptation, Physiological, medicine.anatomical_structure, Neurology, Motor Skills, fMRI, Multiple sclerosis, Hand movement, Multi-centre, Adaptation, Female, Psychology, business, Neuroscience
Abstract

Short-term adaptation indicates the attenuation of the functional MRI (fMRI) response during repeated task execution. It is considered to be a physiological process, but it is unknown whether short-term adaptation changes significantly in patients with brain disorders, such as multiple sclerosis (MS). In order to investigate short-term adaptation during a repeated right-hand tapping task in both controls and in patients with MS, we analyzed the fMRI data collected in a large cohort of controls and MS patients who were recruited into a multi-centre European fMRI study. Four fMRI runs were acquired for each of the 55 controls and 56 MS patients at baseline and 33 controls and 26 MS patients at 1-year follow-up. The externally cued (1 Hz) right hand tapping movement was limited to 3 cm amplitude by using at all sites (7 at baseline and 6 at follow-up) identically manufactured wooden frames. No significant differences in cerebral activation were found between sites. Furthermore, our results showed linear response adaptation (i.e. reduced activation) from run 1 to run 4 (over a 25 minute period) in the primary motor area (contralateral more than ipsilateral), in the supplementary motor area and in the primary sensory cortex, sensory-motor cortex and cerebellum, bilaterally. This linear activation decay was the same in both control and patient groups, did not change between baseline and 1-year follow-up and was not influenced by the modest disease progression observed over 1 year. These findings confirm that the short-term adaptation to a simple motor task is a physiological process which is preserved in MS.

Published
2009

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