Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy.

Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy.
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DOI:
10.1177/17407745221105509
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发表时间:
2022-12
期刊:
Clinical trials (London, England)
影响因子:
--
通讯作者:
Cholesterol Treatment Trialists' Collaboration
Cholesterol Treatment Trialists' Collaboration
中科院分区:
其他
文献类型:
--
作者:
Cholesterol Treatment Trialists' Collaboration

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通常需要对随机试验的个体水平数据进行荟萃分析,以发现有临床价值的效果。胆固醇治疗试验合作组织(The Cholesterol Treatment Trialists ' Collaboration)收集了许多大型长期他汀类药物试验的数据,正在对他汀类药物治疗对这些试验中收集的所有不良事件的影响进行评估。本文描述了系统地捕获和分类数据所使用的方法和面临的挑战。获得方案、统计分析计划、病例报告表、临床研究报告和数据集,进行审查和核对。然后,根据临床数据交换标准联盟研究数据制表模型,将每个试验的相关基线和随访数据重组为标准化格式。不良事件数据被组织和编码(自动或在必要时手动),根据基于《监管活动医学词典》的通用医学词典。通过直接数据传输或在线获取平台,提供了23项双盲他汀试验和5项开放标签他汀试验的数据。这些试验总共提供了845个数据集,包含超过3800万条记录,涉及30,495个研究变量和181,973名随机参与者。在可能用于组织数据的46个临床数据交换标准联盟研究数据制表模型域中,确定并利用了与该项目最相关的13个域,包括6个与随机化后不良事件相关的域。近120万不良事件被提取出来,并映射到超过45,000个独特的不良事件术语。在这些不良事件中,99%被编码到《监管活动医学词典》的“较低级别术语”中,其余的被编码到“较高级别术语”中,或者很少被编码到“较高级别组术语”中。在这项对他汀类药物的大型随机试验不良事件数据的荟萃分析中,基于数据组织和分类的共同标准的方法提供了一种能够对他汀类药物治疗的任何先前未知的益处或危害进行可靠和快速评估的资源。
Meta-analyses of individual-level data from randomised trials are often required to detect clinically worthwhile effects. The Cholesterol Treatment Trialists’ Collaboration, which includes data from numerous large long-term statin trials, is conducting a review of the effects of statin therapy on all adverse events collected in those trials. This article describes the approaches used and challenges faced to systematically capture and categorise the data. Protocols, statistical analysis plans, case report forms, clinical study reports and datasets were obtained, reviewed and checked. Relevant baseline and follow-up data from each trial was then reorganised into standardised formats based upon the Clinical Data Interchange Standards Consortium Study Data Tabulation Model. Adverse event data were organised and coded (automatically or, where necessary, manually) according to a common medical dictionary based upon the Medical Dictionary for Regulatory Activities. Data from 23 double-blind statin trials and 5 open-label statin trials were provided, either through direct data transfer or through online access platforms. Together, these trials provided 845 datasets containing over 38 million records relating to 30,495 study variables and 181,973 randomised participants. Of the 46 Clinical Data Interchange Standards Consortium Study Data Tabulation Model domains that could potentially have been used to organise the data, the 13 most relevant to the project were identified and utilised, including 6 domains related to post-randomisation adverse events. Nearly 1.2 million adverse events were extracted and mapped to over 45,000 unique adverse event terms. Of these adverse events, 99% were coded to a Medical Dictionary for Regulatory Activities ‘lower level term’, with the remainder coded to a ‘higher level term’ or, very rarely, only a ‘higher level group term’. In this meta-analysis of adverse event data from the large randomised trials of statins, approaches based on common standards for data organisation and classification have provided a resource capable of allowing reliable and rapid evaluation of any previously unknown benefits or hazards of statin therapy.
DOI: 10.1016/s0140-6736(10)60310-8
发表时间: 2010-11-13
期刊: LANCET
影响因子: 168.9
作者:
Armitage, Jane;Bowman, Louise;Wallendszus, Karl;Bulbulia, Richard;Rahimi, Kazem;Haynes, Richard;Parish, Sarah;Peto, Richard;Collins, Rory;Meade, T.;Sleight, P.;Collins, R.;Armitage, J.;Bowman, L.;Parish, S.;Peto, R.;Barton, J.;Bray, C.;Wincott, E.;Dayanandan, R.;Clarke, R.;Graham, I.;Simpson, D.;Warlow, C.;Wilken, D.;Tobert, J.;Mushner, T.;Doll, R.;Wilhelmsen, L.;Fox, K.;Hill, C.;Sandercock, P.;Webster, J.;Henderson, J.;Nixon, A.;Lackie, S.;Thompson, J.;Brown, M.;Blackwood, S.;Morgan, M.;Rhoden, W.;Saeed, B.;Houghton, M.;Nicholson, A.;Simpson, C.;Hoburn, B.;Cooper, I.;Gallivan, A.;Pickerell, E.;Hancock, J.;Watkinson, J.;Ryder, B.;Jones, S.;Burbridge, W.;Kitchen, M.;Leary, H. O.;Verow, C.;Meynell, L.;Rollinson, L.;Bain, S.;Jones, A.;Jewkes, C.;Russon, C.;Bateson, M.;Gill, P.;Nicol, J.;Bayly, G.;Stansbie, D.;Andrews, G.;Halestrap, M.;Meredith, J.;Best, R.;Appleyard, D.;Briggs, R.;Wareing, H.;Holmes, K.;Holt, J.;Kenyon, M.;White, C.;Khalifa, M.;Newton, D.;Wass, A.;Watkinson, R.;Creamer, J.;Anderson, S.;Bethell, A.;Butler, C.;Castro, K.;Washington, M.;Weston, M.;Cleaver, K.;Machin, J.;Wray, R.;Sinclair, J.;Van Aalst, A.;Been, M.;Mattu, R.;Bates, D.;Burke, A.;Gill, L.;Walton, E.;Cowley, M.;Robson, H.;Graham, A.;Rose, G.;Kerr, M.;Mallinson, J.;Peascod, B.;Donnelly, R.;Kalk, J.;Scott, A.;Gibson, T.;Hannah, J.;Henshaw, L.;Margetts, M.;Pearson, N.;Frost, S.;Murray, S.;Marshall, A.;Went, J.;Inman, A.;Simmonds, J.;Teasdale, A.;Kemp, T.;Roberts, G.;Kooner, J.;Cahill, S.;Lloyd, M.;Molloy, O.;Wigley, J.;Galvin, M.;Wilder, C.;Lindley, R.;Shaw, S.;Swainson, C.;Hillis, L.;Johnston, J.;Johnstone, A.;Miller, D.;Kennedy, M.;Mushahwar, S.;Savage, M.;Appleyard, D.;Ayer, G.;Schofield, J.;Greenhalgh, S.;Parks, J.;Speak, S.;Coulson, C.;Papouchado, M.;Carpenter, R.;Wisby, J.;Cobbe, S.;Campbell, C.;Hunter, J.;Young, H.;Gallacher, M.;Lindsay, D.;Halliday, A.;Godfrey, S.;Donahoo, L. O.;Chambers, J.;Wierzbicki, A.;Jones, A.;Parkin, D.;Nwafor, K.;Oldroyd, K.;Vallance, B.;Cunningham, N.;Moreland, G.;Oldroyd, C.;Young, H.;Crawford, M.;Hillson, R.;Knott, K.;Mahabir, N.;Crouch, A.;MacDonald, Y.;Bellamy, C.;Green, J.;Brown, L.;Heron, J.;Jones, N.;Roberts, M.;Hainsworth, D.;Williams, J.;Barnes, P.;Fitchet, A.;Longworth, C.;Davidson, J.;Irvine, N.;Oliver, R.;Pond, C.;Nuttall, M.;Mostyn, R. Lloyd;Brown, M.;Barrowcliffe, J.;Blackburn, S.;Furnell, W.;Webster, S.;Wheatley, L.;Hudson, I.;Pohl, J.;Nicholson, S.;Mallya, S.;Nash, M.;Spruce, J.;Bonner, A.;Leather, J.;Searle, A.;Davies, E.;Egdell, R.;Price, B.;Bennett, A. Taylor;Horton, S.;Cunnington, A.;Giles, P.;Sidaway, J.;Tomlinson, L.;Walton, E.;Hawkins, L.;Long, J.;Murphy, J.;Brennan, G.;Boon, M.;Cassidy, S.;Rodger, C.;Hunter, J.;McNeilly, A.;Moreland, G.;Radcliffe, A.;Farrer, M.;Bluett, J.;Cowell, L.;Farrell, A.;Gilroy, S.;Warren, S.;MacConnell, T.;Burtchaell, S.;Williams, L.;Rylance, P.;Hodgson, A.;Hill, K. Kertland;Robinson, L.;Smallwood, A.;Lomas, S.;Ball, J.;Benbow, S.;Hardy, K.;Gerrard, M.;Langley, C.;Beattie, M.;Fagan, C.;Green, B.;Pringle, T.;Hanna, H.;Mackintosh, A.;Watson, E.;Swan, J.;Appleyard, D.;McSorland, D.;Thompson, G.;Neill, C. O.;Curless, R.;Doig, C.;McKenna, P.;Martin, J.;Murdy, J.;Scott, A.;Martin, S.;Birkhead, J.;Donnell, J. O.;Fox, C.;Dixon, S.;Hassall, A.;Tanqueray, E.;Vass, D.;Cosford, I.;Elderkin, M.;McKenzie, P.;Gray, T.;Appleyard, D.;Holmshaw, N.;McKinnon, A.;Bennett, A. Taylor;Ali, I.;Stephens, N.;Banfield, A.;Chester, L.;Wiseman, J.;Harrisingh, N.;Patel, R.;Thaker, P.;Armitage, J.;Watkins, H.;Beebe, S.;Fitzgerald, J.;Godden, J.;Lawson, A.;Lochhead, H.;Taylor, A.;Turner, S.;Rowlands, D.;Cooper, A.;Graham, J.;Hennessy, S.;Rashid, T.;Smith, C.;Nyman, C.;Adams, J.;Hardwick, A.;Buck, P.;Pattinson, C.;Trigg, J.;McLeod, A.;Gardner, S.;Haimes, L.;Orr, S.;Johns, S.;Capps, N.;Cook, A.;Donaldson, D.;Keighley, C.;Stiles, C.;Asbridge, S.;Buller, N.;Townend, J.;Hooks, J.;Jewkes, C.;Jones, H.;Watson, R.;Salt, P.;Francis, M.;MacLeod, D.;Allcoat, P.;Stuart, R.;Reynolds, T.;Maiden, J.;Reynolds, J.;Murray, D.;MacFadyen, R.;Potts, L.;Smith, A.;King, L.;Muthusamy, R.;Jones, M.;Lawan, M.;Nixon, J.;Wasnidge, L.;Weston, C.;Hutchesson, A.;Evans, J.;Morris, K.;Oultram, M.;Armitage, M.;Skule, R.;Cope, C.;Page, M.;Fleming, S.;Andain, K.;Parrett, M.;Soper, R.;MacLeod, K.;Gordon, K.;Green, E.;Havill, S.;Stewart, V.;Allen, S.;Henson, S.;Rimmer, C.;Davies, J.;Javed, M.;Norris, A.;Williams, M.;Khan, S.;Dobie, G.;Fitton, J.;Gilbert, S.;Davenport, C.;Williamson, M.;Vincent, R.;Joyce, E.;Reckless, J.;Bishop, A.;Brice, L.;Carpenter, R.;Field, P.;Shute, C.;Pope, S.;Stacey, D.;Findlay, I.;Campbell, C.;Hunter, J.;Gallacher, M.;Labib, M.;Hodgson, A.;Sidaway, J.;Beddoe, L.;Reed, J.;Barron, J.;Odemuyiwa, O.;Bradford, B.;McDonnell, M.;West, L.;Beck, P.;Gilbey, S.;Clarkson, A.;Drury, K.;Hall, S.;Quartey, D.;Whittam, B.;Lund, D.;Stott, L.;Griffiths, H.;Appleyard, D.;Fitzgerald, J.;Kudarenko, A.;Watkins, J.;Golledge, S.;Pottle, J.;Little, S.;Paine, B.;Shears, C.;Baxter, M.;Wilkinson, P.;Chambers, R.;Hamper, C.;Hollister, E.;Ramsay, H.;Barber, J.;Hopkins, T.;Hughes, L.;Whittaker, J. Elson;Verow, C.;Burke, R. Lambley;Lloyd, C.;Dhawan, J.;John, J.;Bramley, D.;Catchpole, A.;Colecchia, A.;Gray, C.;LeQuelenec, M.;Remington, D.;Wiseman, J.;Gray, C.;Anderson, P.;Woolass, R.;Thomas, P.;Weston, C.;Guy, F.;Lynch, J.;Thomas, R.;Coates, S.;Gait, M.;Waller, D.;Elkins, K.;Franklin, M.;Moore, L.;Signy, M.;Chilton, R.;Joyce, E.;Wrapson, C.;Wiltshire, C.;Lewis, P.;Curtis, J.;Toole, J. O.;Scanlon, S.;Carey, C.;Dobson, L.;Gould, M.;Mansfield, H.;Ranson, G.;Rodaway, M.;Germon, J.;Cockcroft, J.;McDowell, I.;Field, R.;Whiting, J.;Dennison, C.;Roberts, D.;Cooper, M.;Davies, C.;Fitton, J.;Hutt, L.;Radford, L.;Ward, L.;Williamson, M.;McAlpine, H.;Dougall, H.;Robertson, L.;Scott, L.;Young, H.;Humphrey, P.;Saminaden, S.;Watling, D.;Davies, J.;Owen, L.;Clements, M.;Walker, E.;Atkins, E.;Lindley, R.;Shaw, T.;Swainson, C.;Webb, D.;MacCallum, H.;Markie, D.;Melville, V.;Adamson, L.;Johnston, A.;Polukord, E.;Rudden, M.;Hogan, J.;Lie, F.;Badger, V.;Duffy, S.;Mitchell, C.;MacQueen, E.;Baxter, R.;Campbell, S.;McDonald, L.;Wood, H.;Munro, A.;Pycock, C.;Cadwell, J.;Doughty, A.;Harvey, M.;Price, S.;Aldersley, M.;Lock, S.;Pendrey, P.;Barton, J.;Bray, C.;Dayanandan, R.;Wmcott, E.;Achiri, P.;Anderson, C.;Benham, J.;Bojowsky, H.;Boller, I.;Booker, V.;Brewer, A.;Brindley, G.;Cobb, L.;Collett, A.;Corbett, M.;Crowther, J.;Pour, S. Danesh;Edmunds, K.;Fortun, A.;Grimsey, T.;Harwood, C.;Hope, C.;Jones, R.;Jones, S.;Kidney, K.;King, M.;Knight, S.;Lang, H.;Madgwick, Z.;Marsden, C.;Matthews, C.;Matthewson, M.;Miller, J.;Moss, B.;Mostefai, Y.;Murphy, K.;Naughten, A.;Pickworth, S.;Radley, A.;Southren, S.;Sutherland, S.;Tong, R.;Turakani, M.;Umbrath, M.;Armitage, J.;Baigent, C.;Bowman, L.;Bulbulia, R.;Chen, Z.;Clarke, R.;Collins, R.;Dunachie, S.;Dasgupta, T.;Haynes, R.;Landray, M.;Mafham, M.;Majoni, W.;Murray, C.;Naessens, K.;Porter, T.;Rahimi, K.;Reith, C.;Clarke, M. Taylor;Turnbull, C.;Walter, K.;Harding, P.;Lay, M.;Wallendszus, K.;Berry, C.;Bettesworth, H.;Booth, J.;Bowes, M.;Bu, Y.;Charles, A.;Cody, A.;Cox, J.;Emberson, J.;Goodwin, N.;Hurt, C.;Link, E.;McCabe, P.;Munday, A.;Murawska, A.;Offer, A.;Palmer, A.;Parish, S.;Peto, R.;Prajapati, N.;Tochlin, S.;Young, A.;Young, A.;Clark, S.;Kourelhas, K.;Radley, M.;Ambrose, V.;Bradley, M.;Bush, E.;Chavagnon, T.;Chukwurah, B.;Crowley, S.;Dunseath, J.;Emmens, K.;Fletcher, L.;Gordon, J.;Gordon, A.;Hickman, C.;Hill, J.;Ji, M.;Lee, A.;Luker, N.;Norris, S.;Priestley, H.;Sullivan, J.;Taylor, J.;Wintour, J.;Yeung, M.;Youngman, L.;Beebe, S.;Fitzgerald, J.;Godden, J.;Haimes, L.;Lawson, A.;Lochhead, H.;McDonnell, M.;Nash, M.;Taylor, A.;Bennett, A. Taylor;Walton, E.
通讯作者: Walton, E.
DOI: 10.1001/jama.294.19.2437
发表时间: 2005-11-16
影响因子: 120.7
作者:
Pedersen, TR;Faergeman, O;Tsai, J
通讯作者: Tsai, J
DOI: 10.1016/s0140-6736(03)13638-0
发表时间: 2003-06-14
期刊: LANCET
影响因子: 168.9
作者:
Holdaas, H;Fellström, B;Pedersen, TR
通讯作者: Pedersen, TR
DOI: 10.1001/jama.292.11.1307
发表时间: 2004-09-15
影响因子: 120.7
作者:
de Lemos, JA;Blazing, MA;Braunwald, E
通讯作者: Braunwald, E
DOI: 10.1093/jamiaopen/ooaa064
发表时间: 2020-12
期刊: JAMIA open
影响因子: 2.1
作者:
Hong JC;Fairchild AT;Tanksley JP;Palta M;Tenenbaum JD
通讯作者: Tenenbaum JD