Documents
Protocol, Guidelines and Handbook
- Protocol (version 6.0 dated 28-Aug-2013) (pdf)
- Trial summary (pdf)
- Trial summary - flow diagram only (pdf)
- Handbook (England & Wales) (pdf)
Statistical Analysis Plans
- Statistical analysis plan for morphological analyses (pdf)
- Cohort of patients with aneurysm rupture- Clinical details analysis plan (pdf)
- Statistical analysis plan for analyses at 30-days
- Analysis plan for clinical and cost-effectiveness analyses at 1-year (pdf)
- Analysis plan for clinical and cost-effectiveness analyses at 3 years (pdf)
AJAX (Dutch), ECAR (French) and IMPROVE trials agree an individual patient meta-analysis: even better evidence for management of ruptured AAAs. Read more in the Individual Patient Data meta-analysis statistical analysis plan (pdf)
Publications
Three primary outcome papers have been published, for 30-day, 1-year and 3-year results:
- IMPROVE trial investigators BMJ 2014 ; 348:f7661
- IMPROVE trial investigators Eur Heart J 2015 ;36: 2061-2069
- IMPROVE trial investigators BMJ 2017;359:j4859
Six other papers have been published, four from the IMPROVE trial only and two from collaborative projects with the other European trials AJAX and ECAR
- IMPROVE trial investigators. Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm; Br J Surg 2014, 101, Issue 3, pages 216–224
- IMPROVE trial investigators. The effect of aortic morphology on peri-operative mortality of ruptured abdominal aortic aneurysm; Eur Heart J 2015; 36: 1328-1334
- Powell JT, Sweeting MJ, Ulug P, Thompson MM, Hinchliffe RJ, IMPROVE Trial Investigators. Re-interventions After Repair of Ruptured Abdominal Aortic Aneurysm: A Report From the IMPROVE Randomised Trial., Eur J Vasc Endovasc Surg (2018) 55, 625e632
- Sweeting MJ et al. Value of risk scores in the decision to palliate patients with ruptured abdominal aortic aneurysm, BJS 2018 (in press)
- Sweeting MJ, Balm R, Desgranges P, Ulug P, Powell JT. Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm; Br J Surg 2015;102(10):1229-39
- Sweeting MJ, Ulug P, Powell JT, Desgranges P, Balm R, Ruptured Aneurysm Trialists. Ruptured Aneurysm Trials: The Importance of Longer-term Outcomes and Meta-analysis for 1-year Mortality; Eur J Vasc Endovasc Surg 2015; 50(3):297-302
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An editorial in Eur J Vasc Endovasc Surgery 2014 14(4): 333-4
Finally, a comment about flexible consent processes for emergency trials from the Chief Investigator and Trial Manager has been published in the British Medical Journal:
- Powell JT, Ulug P, Flexible consent BMJ 2015; 351:h4608