Introduction of new non-pharmacological technology is challenging and the methodology for evaluationg such technologies is much less standardized than when dealing with new pharmacological substances. It is, however, as important to use randomized design with blinded assessment and combine that with prospective population based registries to be able to analyze generalizability.
The EC/IC Bypass Study Group: Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med1985;313:1191–1200.
2.
BarnettHJFoxAHachinskiVHaynesBPeerlessSJSackettDTaylorDW: Further conclusions from the extracranial-intracranial bypass trial. Surg Neurol1986;26:227–235.
3.
European Carotid Surgery Trialists' Collaborative Group: MRC European Carotid Surgery Trial: Interim results for symptomatic patients with severe (70–99) or with mild (0–29) carotid stenosis. Lancet1991;337:1235–1243.
4.
van der LindenW: Pitfalls in randomized surgical trials. Surgery1980;87:258–262.
5.
LilfordRJBraunholtzDAGreenhalghREdwardsSJ: Trials and fast changing technologies: The case for tracker studies. Bmj2000;320:43–46.
6.
NaylorARBoliaAAbbottRJ: Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: A stopped trial. J Vasc Surg1998;28:326–334.
7.
MasJLChatellierGBeyssenB: Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med2006;355:1660–1671.
8.
RinglebPAAllenbergJBruckmannH: 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: A randomised non-inferiority trial. Lancet2006;368:1239–1247.
9.
KragstermanBBjorckMLindbackJ: Long-term survival after carotid endarterectomy for asymptomatic stenosis. Stroke2006;37:2886–2891.
10.
KragstermanBParssonHLindbackJ: Outcomes of carotid endarterectomy for asymptomatic stenosis in Sweden are improving: Results from a population-based registry. J Vasc Surg2006;44:79–85.
11.
BjorckCGBergqvistDGlimakerH: Increased thrombogenicity after polymer coating: Experiences with the first version of a new woven Dacron graft for aortic reconstruction. Eur J Surg1994;160:9–14; discussion 15–16.
12.
MaddernG: The Australian Safety and Efficacy Register of New Interventional procedures — Surgical (ASERNIP-S) assesses new surgeries. Aust Health Rev2004;28:143–144.
13.
BergqvistD: The annual meeting of the European Society for Vascular Surgery—the scientific contents over the years. Eur J Vasc Endovasc Surg2008;36:114–117.
14.
PanesarSSThakrarRAthanasiouTSheikhA: Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: Literature review. J R Soc Med2006;99:470–472.
15.
BergqvistDDelleMHolstJ: Symtomgivande benartärsjukdom — Diagnostik och behandling. En systematisk litteraturöversikt. SBU. 2007;187:1–704.
16.
Report: NASCET, North American Symptomatic Carotid Endarterectomy Trial Collaborators: Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Eng J Med1991;325:445–452.
17.
HallidayAMansfieldAMarroJ: Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: Randomised controlled trial. Lancet2004;363:1491–1502.
18.
AdamDJBeardJDClevelandT: Bypass versus angioplasty in severe ischaemia of the leg (BASIL): Multicentre, randomised controlled trial. Lancet2005;366:1925–1934.
19.
EVAR trial participants: Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): Randomised controlled trial. Lancet2005;365:2179–2186.
20.
PrinssenMVerhoevenELButhJ: A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med2004;351:1607–1618.