Study Design and Protocol Writing

 Study

Publication

Lauritzen T, Griffin S, Borch-Johnsen K, Wolffenbuttel BHR, Rutten G. The Addition study: proposed trial of the cost-effectiveness of an intensive multifactorial intervention on morbidity and mortality among people with Type 2 diabetes detected by screening for the Addition Study Group. Int J Obesity 2000;24:6-11.

Beulens JW, Patel A, Vingerling JR, Cruickshank JK, Hughes AD, Stanton A, Lu J, McG Thom SA, Grobbee DE, Stolk RP; AdRem project team; ADVANCE management committee. Effects of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in patients with type 2 diabetes mellitus: a randomised controlled trial. Diabetologia 2009;52(10):2027-36.

Stolk RP, van Schooneveld MJ, Cruickshank JK, Hughes AD, Stanton A, Lu J, Patel A, Thom SA, Grobbee DE, Vingerling JR. Retinal vascular lesions in patients with type 2 diabetes mellitus of Caucasian and Asian origin - baseline results from the AdRem study. Diabetes Care 2008;31(4):708-13.

Stolk RP, Vingerling JR, Cruickshank JK, Hughes AD, Stanton A, Juming L, Patel A, Thom SA, Grobbee DE. Rationale and design of the AdRem study: evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus. Contemp Clin Trials. 2007;28(1):6-17.

de Galan BE, Zoungas S, Chalmers J, Anderson C, Dufouil C, Pillai A, Cooper M, Grobbee DE, Hackett M, Hamet P, Heller SR, Lisheng L, Macmahon S, Mancia G, Neal B, Pan CY, Patel A, Poulter N, Travert F, Woodward M; ADVANCE Collaborative Group. Cognitive function and risks of cardiovascular disease and hypoglycaemia in patients with type 2 diabetes: the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Diabetologia 2009;52(11):2328-36.

Zoungas S, de Galan BE, Ninomiya T, Grobbee D, Hamet P, Heller S, MacMahon S, Marre M, Neal B, Patel A, Woodward M, Chalmers J; ADVANCE Collaborative Group, Cass A, Glasziou P, Harrap S, Lisheng L, Mancia G, Pillai A, Poulter N, Perkovic V, Travert F. Combined effects of routine blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes in patients with type 2 diabetes: New results from the ADVANCE trial. Diabetes Care 2009;32(11):2068-74.

Heller SR; ADVANCE Collaborative Group. A summary of the ADVANCE Trial. Diabetes Care 2009;32(2):357-61.

Kengne AP, Czernichow S, Huxley R, Grobbee D, Woodward M, Neal B, Zoungas S, Cooper M, Glasziou P, Hamet P, Harrap SB, Mancia G, Poulter N, Williams B, Chalmers J; ADVANCE Collaborative Group. Blood pressure variables and cardiovascular risk: new findings from ADVANCE. Hypertension 2009;54(2):399-404. 

Du X, Ninomiya T, de Galan B, Abadir E, Chalmers J, Pillai A, Woodward M, Cooper M, Harrap S, Hamet P, Poulter N, Lip GY, Patel A; ADVANCE Collaborative Group. Risks of cardiovascular events and effects of routine blood pressure lowering among patients with type 2 diabetes and atrial fibrillation: results of the ADVANCE study. Eur Heart J. 2009;30(9):1128-35. 

The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008; 358:2545-59.

Chalmers J, Joshi R, Kengne AP, Ninomiya T, Bi Y, Bompoint S, Billot L, Patel A; ADVANCE Collaborative Group. Efficacy and safety of fixed combination of perindopril and indapamide in type 2 diabetes: results from ADVANCE in context of available evidence. J Hypertens Suppl. 2008;26(3):21-7.

Chalmers J, Joshi R, Kengne AP, Ninomiya T, Bi Y, Bompoint S, Billot L, Patel A; ADVANCE Collaborative Group. Efficacy and safety of fixed combination of perindopril and indapamide in type 2 diabetes: results from ADVANCE in context of available evidence. J Hypertens. 2008;26(3):23-30.

Patel A; ADVANCE Collaborative Group, MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee DE, Hamet P, Heller S, Liu LS, Mancia G, Mogensen CE, Pan CY, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomized controlled trial. Lancet 2007;370(9590):829–40.

ADVANCE Collaborative Group. ADVANCE—Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline. Diabet Med. 2005;22(7):882–888.

Laan W, Selten JP, Kahn RS, Huisman AM, Heijnen CJ, Grobbee DE, Burger H. Acetylsalicylic acid as an adjuvant therapy for schizophrenia. Trials 2006;7:31.

van der Weerd NC, Penne EL, Grooteman MPC. Letter to the editor: Effect of hemofiltration (HF) on mortality: no definite answer yet. Am J Kidney Dis. 2009;53:562-3.

Penne EL, van der Weerd NC, Grooteman MPC, Blankestijn PJ. Letter to the editor: Results from the RISCAVID study: is haemodiafiltration associated with improved survival? Nephrol Dial Trasnplant 2008;23(9):3034.

van der Weerd NC, Penne EL, Bots ML, van den Dorpel MA, Grooteman MPC, Nubé MJ, Ter Wee PM, Blankestijn PJ. Haemodiafiltration: promise for the future? Nephrol Dial Transplant 2008;23:438-443.

Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MPC, Nubé MJ en  ter Wee PM. The role of on-line hemodiafiltration at reducing cardiovascular morbidity and mortality for chronic hemodialysispatients. Ned Tijdschr Geneesk. 2006;150:1583-5.

Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman  MP, Nube MJ, Ter Wee PM; CONTRAST study group. Resolving controversies regarding hemodiafiltration versus hemodialysis: the Dutch Convective Transport Study. Semin Dial. 2005;18:47-51.

Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nube MJ, van der Tweel I, ter Wee PM; the CONTRAST study group. Effect of increased convective clearance by on-line hemodiafiltration on all cause and cardiovascular mortality in chronic hemodialysis patients - the Dutch CONvective TRAnsport STudy (CONTRAST): rationale and design of a randomised controlled trial. Curr Control Trials Cardiovasc Med. 2005;6(1):8.

Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM, Verhagen HJ, Buskens E, Grobbee DE; Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2005;352(23):2398-405.

Prinssen M, Buskens E, Nolthenius RP, van Sterkenburg SM, Teijink JA, Blankensteijn JD. Sexual dysfunction after conventional and endovascular AAA repair: results of the DREAM trial. J Endovasc Ther. 2004;11(6):613-20.

Prinssen M, Buskens E, Blankensteijn JD; DREAM trial participants. Quality of life endovascular and open AAA repair. Results of a randomised trial. Eur J Vasc Endovasc Surg. 2004;27(2):121-7.

Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004;351(16):1607-18.

Prinssen M, Buskens E, Blankensteijn JD. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods. J Cardiovasc Surg (Torino). 2002;43(3):379-84.

Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IP, Gheorghe MD, Rybakowski JK, Galderisi S, Libiger J, Hummer M, Dollfus S, López-Ibor JJ, Hranov LG, Gaebel W, Peuskens J, Lindefors N, Riecher-Rössler A, Grobbee DE; EUFEST study group. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomized clinical trial. Lancet 2008;371:1085-97.

Fleischhacker WW, Keet IPM, Kahn RS. The European first episode schizophrenia trial (EUFEST): rationale and design of the trial. Schizoph Research 2005;78:147-156.

Fox KM, EURopean trial On reduction of cardiac events with Perindopril in stable coronary Artery disease Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet 2003;362:782-8.

Gomma AH, Fox KM, on behalf of the EUROPA Investigators. The EUROPA trial: design, baseline demography and status of the substudies. Cardiovasc Drugs Ther. 2001;15:169-79.

van Zuilen AD, Wetzels JFM, Bots ML, Blankestijn PJ. MASTERPLAN: study of the role of nurse practitioners in a multifactorial intervention to reduce cardiovascular risk in chronic kidney disease patients. J Nephrol. 2008;21(3):261-7.

van Zuilen AD, van der Tweel I, Blankensteijn PJ, Bots ML, van Buren M, Kaasjager MAGJ , Ligtenberg G, van de Ven PJ, Vervoort G, Sijpkens YW , Sluiter HE, Vleming LJ , Wetzels JFM. Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners. Design of the Masterplan study. Trials 2006;7:8.

Bots ML, Palmer MK, Dogan S, Plantinga Y, Raichlen JS, Evans GW, O'Leary DH, Grobbee DE, Crouse JR 3rd; METEOR Study Group. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of treatment: the METEOR study. J Intern Med. 2009;265(6):698-707. 

Crouse JR 3rd, Bots ML, Evans GW, Palmer MK, Oʼleary DH, Grobbee DE, Raichlen JS; on behalf of the METEOR Study Group. Does baseline carotid intima-media thickness modify the effect of rosuvastatin when compared with placebo on carotid intima-media thickness progression? The METEOR study. Eur J Cardiovasc Prev Rehabil. 2009. 

Crouse JR 3rd, Grobbee DE, O'Leary DH, Bots ML, Evans GW, Palmer MK, Riley WA, Raichlen JS, Meteor study Group. Carotid intima-media thickness in low-risk individuals with asymptomatic atherosclerosis: baseline data from the METEOR study. Curr Med Ser Opin. 2007;23(3):641-648. 
 

Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA 2007;297(12):1344-53. 

Crouse JR 3rd, Grobbee DE, O'Leary DH, Bots ML, Evans GW, Palmer MK, Riley WA, Raichlen JS. Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin in Subclinical Atherosclerosis—The Rationale and Methodology of the METEOR Study. Cardiovasc Drugs Ther. 2004;18(3):231-8.

van Dijk D, Nierich APEFD, Buskens E, Nathoe HM, Jansen EWL, Borst C, Knape JTA, Bredee JJ, Robles de Medina EO, Grobbee DE, Diephuis JC, de Jaegere PP. The Octopus Study: Rationale and design of two randomized trials on medical effectiveness, safety and cost-effectiveness of by-pass surgery on the beating heart. Control Clin Trials 2000;21:595-609.

van Wijck AJ, Opstelten W, Moons KG, van Essen GA, Stolker RJ, Kalkman CJ, Verheij TJ. The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia: a randomised controlled trial. Lancet 2006;367(9506):219-24.

Opstelten W, Van Wijck AJ, Van Essen GA, Buskens E, Bak AA, Kalkman CJ, Verheij TJ, Moons KG. The PINE study: rationale and design of a randomised comparison of epidural injection of local anaesthetics and steroids versus care-as-usual to prevent postherpetic neuralgia in the elderly. BMC Anesthesiol. 2004;4(1):2.