Randomized versus historical controls for clinical trials
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Fletcher, 1979, Clinical research in general medical journals. A 30-year perspective, N Engl J Med, 30, 180, 10.1056/NEJM197907263010403
Bonchek, 1980, Are randomized trials appropriate for evaluating new operations?, N Engl J Med, 301, 44, 10.1056/NEJM197907053010110
Van der Linden, 1980, Pitfalls in randomized surgical trials, Surgery, 87, 258
Gehan, 1974, Non-randomized controls in cancer clinical trials, N Engl J Med, 290, 198, 10.1056/NEJM197401242900405
Freireich, 1979, The limitations of the randomized clinical trial, XVII, 277
1978, Biomedicine Special Issue, 28, 1
Fleiss, 1973, Statistical methods for rates and proportions, 165
Burchart, 1976, Experiences with the Linton-Nachlas and the Sengstaken-Blakemore tubes for bleeding esophageal varices, Surg Gynecol Obstet, 142, 529
Chojkier, 1979, A controlled comparison of continuous intra-arterial and intravenous infusions of vasopressin in hemorrhage from esophageal varices, Gastroenterology, 77, 540, 10.1016/0016-5085(79)90020-9
Johnson, 1977, Control of bleeding varices by vasopressin: a prospective randomized study, Ann Surg, 186, 369, 10.1097/00000658-197709000-00015
Merigan, 1962, Effect of intravenously administered posterior pituitary extract on hemorrhage from bleeding esophageal varices, N Engl J Med, 266, 134, 10.1056/NEJM196201182660307
Orloff, 1962, A comparative study of emergency transesophageal ligation and nonsurgical treatment of bleeding esophageal varices in unselected patients with cirrhosis, Surgery, 52, 103
Sampliner, 1975, Use of blood component therapy for gastrointestinal bleeding in patients with cirrhosis of the liver, Johns Hopkins Med J, 136, 163
Terblanche, 1979, A prospective controlled trial of sclerotherapy in the long term management of patients after esophageal variceal bleeding, Surg Gynecol Obstet, 148, 323
Teres, 1978, Esophageal tamponade for bleeding varices, Gastroenterology, 75, 566, 10.1016/S0016-5085(19)31660-9
Jackson, 1971, A clinical investigation of the portacaval shunt. V. Survival analysis of the therapeutic operation, Ann Surg, 174, 672, 10.1097/00000658-197110000-00012
Mikkelsen, 1974, Therapeutic portacaval shunt, Arch Surg, 108, 302, 10.1001/archsurg.1974.01350270036007
Resnick, 1974, Boston Inter-Hospital Liver Group: A controlled study of the therapeutic portacaval shunt, Gastroenterology, 67, 843, 10.1016/S0016-5085(19)32736-2
Rueff, 1976, A controlled study of therapeutic shunt in alcoholic cirrhosis, Lancet, I, 655, 10.1016/S0140-6736(76)92775-6
Jackson, 1968, A clinical investigation of the portacaval shunt. II. Survival analysis of the prophylactic operation, Am J Surg, 115, 22, 10.1016/0002-9610(68)90127-X
Resnick, 1969, A controlled study of the prophylactic portacaval shunt, Ann Intern Med, 70, 675, 10.7326/0003-4819-70-4-675
Bismuth, 1974, Portacaval-systemic shunt in hepatic cirrhosis: does the type of shunt decisively influence the clinical result?, Ann Surg, 179, 209, 10.1097/00000658-197402000-00019
Galambos, 1976, Selective and total shunts in the treatment of bleeding varices, N Engl J Med, 295, 1089, 10.1056/NEJM197611112952001
Langer, 1980, A prospective randomized trial of the selective distal splenorenal shunt, Surg Gynecol Obstet, 150, 45
Malt, 1978, Randomized trial of emergency mesocaval and portacaval shunts for bleeding esophageal varices, Am J Surg, 135, 584, 10.1016/0002-9610(78)90041-7
Reichle, 1979, Prospective comparative clinical trial with distal splenorenal and mesocaval shunts, Am J Surg, 137, 13, 10.1016/0002-9610(79)90004-7
Hallenbeck, 1963, Results after portal-systemic shunts in 120 patients with cirrhosis of the liver, Surg Gynecol Obstet, 116, 435
Orloff, 1975, Portacaval shunt as emergency procedure in unselected patients with alcoholic cirrhosis, Surg Gynecol Obstet, 141, 59
Terblanche, 1979, A prospective evaluation of injection sclerotherapy in the treatment of acute bleeding from esophageal varices, Surgery, 85, 239
Baird, 1971, Emergency portal decompression. A review of 31 patients operated upon via a midline approach, Arch Surg, 103, 73, 10.1001/archsurg.1971.01350070099023
Boerema, 1970, Transabdominal ligation-resection of the esophagus in cases of bleeding esophageal varices, Surgery, 67, 409
Conn, 1962, Multiple infusion of posterior pituitary extract in the treatment of bleeding esophageal varices, Ann Intern Med, 57, 804, 10.7326/0003-4819-57-5-804
Hara, 1967, Portacaval shunt for portal hypertension, Arch Surg, 94, 476, 10.1001/archsurg.1967.01330100040006
Hermann, 1971, The results of selection of patients for portal-systemic shunt, Surg Gynecol Obstet, 133, 1008
Johnson, 1969, Control of the hyperdynamic circulation in patients with bleeding esophageal varices, Ann Surg, 169, 661, 10.1097/00000658-196905000-00003
Johnston, 1973, A review of 15 years' experience in the use of sclerotherapy in the control of acute haemorrhage from oesophageal varices, Br J Surg, 60, 797, 10.1002/bjs.1800601011
Levin, 1974, Portasystemic shunts for portal hypertension: early and late results in a personal series of 140 operations, Vasc Surg, 8, 20, 10.1177/153857447400800105
Nusbaum, 1974, Control of portal hypertension. Selective mesenteric arterial infusion of vasopressin, Arch Surg, 108, 342, 10.1001/archsurg.1974.01350270072013
Renwick, 1969, Spleno-renal anastomosis: results in 47 cases, Med J Aust, 1, 755, 10.5694/j.1326-5377.1969.tb105508.x
Reynolds, 1952, Results of the treatment of bleeding esophageal varices with balloon tamponade, Am J Med Sci, 224, 500, 10.1097/00000441-195211000-00003
Rodriguez, 1965, Portal-systemic shunts in the treatment of portal hypertension, Cleve Clin Q, 32, 181, 10.3949/ccjm.32.4.181
Sugiura, 1973, A new technique for treating esophageal varices, J Thorac Cardiovasc Surg, 66, 677, 10.1016/S0022-5223(19)40560-6
Vang, 1977, Results of a modified distal spleno-renal shunt for portaly hypertension, Ann Surg, 185, 224, 10.1097/00000658-197702000-00016
Yamamoto, 1976, The late results of terminal esophagoproximal gastrectomy (TEPG) with extensive devascularization and splenectomy for bleeding isophageal varices in cirrhosis, Surgery, 80, 106
1978, Am J Cardiol, 42, 838
Neill, 1977, Medical vs urgent surgical therapy for acute coronary insufficiency: a randomized study, Cardiovasc Clin, 8, 179
Read, 1978, Survival of men treated for chronic stable angina pectoris: a cooperative randomized study, J Thorac Cardiovasc Surg, 75, 1, 10.1016/S0022-5223(19)41156-2
Kloster, 1979, Coronary bypass for stable angina: a prospective randomized study, N Engl J Med, 300, 149, 10.1056/NEJM197901253000401
Mathur, 1975, Prospective randomized study of coronary bypass surgery in stable angina: the first 100 patients, Circulation, 51 and 52, 133
Mathur, 1977, Prospective randomized study of the surgical therapy of stable angina, Cardiovasc Clin, 8, 131
1979, Coronary-artery bypass surgery in stable angina pectoris: survival at two years, Lancet, I, 889
Bhayana, 1980, Long-term results of internal mammary artery implantation for coronary artery disease: a controlled trial, Ann Thorac Surg, 29, 234, 10.1016/S0003-4975(10)61874-7
Bertolasi, 1974, Unstable angina—prospective and randomized study of its evolution with and without surgery, Am J Cardiol, 33, 201, 10.1016/0002-9149(74)90275-6
Dubost, 1976, Urgency myocardial revascularization, Postgrad Med J, 52, 743, 10.1136/pgmj.52.614.743
Jones, 1978, Impact of multiple variables on operative and extended survival following coronary artery surgery, Surgery, 83, 20
Jones, 1978, Criteria for operability and reduction of surgical mortality in patients with severe left ventricular ischemia and dysfunction, Ann Thorac Surg, 25, 413, 10.1016/S0003-4975(10)63577-1
Lawrie, 1978, Factors influencing late survival after coronary bypass surgery, Ann Surg, 187, 665, 10.1097/00000658-197806000-00013
Carey, 1979, Probability of survival after coronary bypass surgery in Veterans Administration and community hospitals, J Thorac Cardiovasc Surg, 77, 39, 10.1016/S0022-5223(19)40987-2
Hammond, 1973, Early and late results of direct coronary reconstructive surgery for angina, J Thorac Cardiovasc Surg, 65, 127, 10.1016/S0022-5223(19)40833-7
Sheldon, 1975, Surgical treatment of coronary artery disease: pure graft operations, with a study of 741 patients followed 3–7 yrs, Prog Cardiovasc Dis, 18, 237, 10.1016/0033-0620(75)90013-4
Spencer, 1974, The long-term influence of coronary bypass grafts on myocardial infarction and survival, Ann Surg, 180, 439, 10.1097/00000658-197410000-00009
Wukasch, 1976, Surgical vs medical treatment of coronary artery disease: long-term survival, Vasc Surg, 10, 300, 10.1177/153857447601000507
Kaiser, 1978, Myocardial revascularization: a rebuttal of the cooperative study, Ann Surg, 188, 331, 10.1097/00000658-197809000-00008
Isom, 1977, Coronary revascularization with significant impairment of left ventricular contractibility, Cardiovasc Clin, 8, 265
McConahay, 1976, Coronary artery bypass surgery for left main coronary artery disease, Am J Cardiol, 37, 885, 10.1016/0002-9149(76)90114-4
Green, 1979, Coronary bypass surgery: five-year follow-up of a consecutive series of 140 patients, J Thorac Cardiovasc Surg, 77, 48, 10.1016/S0022-5223(19)40988-4
Vineberg, 1975, Evidence that revascularization by ventricular internal mammary artery implants increases longevity, J Thorac Cardiovasc Surg, 70, 381, 10.1016/S0022-5223(19)40312-7
Wisoff, 1975, Risk of coronary surgery, J Thorac Cardiovasc Surg, 69, 669, 10.1016/S0022-5223(19)41498-0
Stiles, 1976, Long-term follow-up of patients with coronary artery bypass grafts, Circulation, 54, 32
Farinha, 1978, Disease of the left main coronary artery: surgical treatment and long-term follow-up in 267 patients, Am J Cardiol, 42, 124, 10.1016/0002-9149(78)90996-7
Karlson, 1975, Myocardial revascularization for patients with unstable angina pectoris: surgical treatment results in less angina and lower long-term mortality risk, RI Med J, 58, 465
Tecklenberg, 1975, Changes in survival and symptom relief in a longitudinal study of patients after bypass surgery, Circularion, 51 and 52, 98
Morton, 1976, Coronary bypass surgery at the Maine Medical Center: a progress report, J Maine Med Assoc, 67, 119
Clarebrough, 1977, Surgery for unstable angina, Aust NZ J Surg, 47, 27, 10.1111/j.1445-2197.1977.tb03930.x
Carleton, 1960, Heparin administration after acute myocardial infarction, N Engl J Med, 263, 1002, 10.1056/NEJM196011172632006
Wasserman, 1966, Anticoagulants in acute myocardial infarction: the failure of anticoagulants to alter mortality in randomized series, Am Heart J, 71, 43, 10.1016/0002-8703(66)90655-7
Drapkin, 1972, Anticoagulant therapy after acute myocardial infarction: Relation of therapeutic benefit to patient's age, sex and severity of infarction, JAMA, 222, 541, 10.1001/jama.1972.03210050013003
Handley, 1972, Heparin in the prevention of deep vein thrombosis after myocardial infarction, Br Med J, 2, 436, 10.1136/bmj.2.5811.436
Greisman, 1948, Acute myocardial infarction: detailed study of dicumarol therapy in seventy-five consecutive cases, Am Heart J, 36, 600, 10.1016/0002-8703(48)90694-2
Furman, 1953, An evaluation of anticoagulant therapy in myocardial infarction based on prognostic categories, Am J Med, 14, 681, 10.1016/0002-9343(53)90386-6
Schnur, 1953, Mortality and other studies questioning the evidence for and value of routine anticoagulant therapy in acute myocardial infarction, Circulation, 7, 855, 10.1161/01.CIR.7.6.855
Burton, 1954, Anticoagulant therapy of recent cardiac infarction, Can Med Assoc J, 70, 404
Honey, 1957, Prognostic factors in myocardial infarction, Lancet, I, 1155, 10.1016/S0140-6736(57)91735-X
Chalmers, 1977, Evidence favoring the use of anticoagulants in the hospital phase of acute myocardial infarction, N Engl J Med, 297, 1091, 10.1056/NEJM197711172972004
Steffensen, 1969, Coronary occlusion treated with small doses of heparin, Acta Med Scand, 186, 519, 10.1111/j.0954-6820.1969.tb01515.x
Handley, 1972, Heparin in the prevention of deep vein thrombosis after myocardial infarction, Br Med J, 2, 436, 10.1136/bmj.2.5811.436
Wray, 1973, Prophylactic anticoagulant therapy in the prevention of calf vein thrombosis after myocardial infarction, N Engl J Med, 288, 815, 10.1056/NEJM197304192881604
Emerson, 1977, Preventing thromboembolism after myocardial infarction: effect of low-dose heparin or smoking, Br Med J, 1, 18, 10.1136/bmj.1.6052.18
Higgins, 1976, Adjuvant chemotherapy in the survival treatment of large bowel cancer, Cancer, 38, 1461, 10.1002/1097-0142(197610)38:4<1461::AID-CNCR2820380402>3.0.CO;2-7
Lawrence, 1978, Chemotherapy as an adjuvant to surgery for colorectal cancer, Arch Surg, 113, 164, 10.1001/archsurg.1978.01370140054011
Grage, 1977, Adjuvant chemotherapy with 5-fluorouracil after surgical resection of colorectal carcinoma, Am J Surg, 133, 59, 10.1016/0002-9610(77)90194-5
Grossi, 1977, Intraluminal fluorouracil chemotherapy adjunct to surgical procedures for resectable carcinoma of the colon and rectum, Surg Gynecol Obstet, 145, 549
Li, 1976, Chemoprophylaxis for patients with colorectal cancer, JAMA, 235, 2825, 10.1001/jama.1976.03260520019015
Rousselot, 1972, Adjuvant chemotherapy with 5-fluorouracil in surgery for colorectal cancer: eight-year progress report, Dis Colon Rectum, 15, 169, 10.1007/BF02589856
Eilber, 1976, Adjuvant immunotherapy with BCG in treatment of regional-lymph-node metastases from malignant melanoma, N Engl J Med, 294, 237, 10.1056/NEJM197601292940501
Deutschmann, 1977, Experience with BCG adjuvant immunotherapy in stage II malignant melanoma, Tumori, 63, 303, 10.1177/030089167706300309
McCulloch, 1977, Recurrent malignant melanoma: effect of adjuvant immunotherapy on survival, Can Med Assoc J, 117, 33
Gutterman, 1978, Postoperative immunotherapy for recurrent malignant melanoma: an updated report, 35
Cunningham, 1978, A controlled study of adjuvant therapy in patients with stage I and II malignant melanoma, 19
Pinsky, 1978, Surgical adjuvant immunotherapy with BCG in patients with malignant melanoma: results of a prospective, randomized trial, 27
Morton, 1978, Adjuvant immunotherapy of malignant melanoma: preliminary results of a randomized trial in patients with lymph node metastases, 57
Wood, 1978, Randomized trial of adjuvant therapy for “high risk” primary malignant melanoma, Surgery, 83, 677
Reid, 1955, The use of hormones in the management of pregnancy in diabetics, Lancet, 269, 833
Dieckmann, 1953, Does the administration of diethylstilbestrol during pregnancy have therapeutic value?, Am J Obstet Gynecol, 66, 1062, 10.1016/S0002-9378(16)38617-3
Ferguson, 1953, Effect of stilbestrol on pregnancy compared to the effect of a placebo, Am J Obstet Gynecol, 65, 592, 10.1016/0002-9378(83)90615-4
Smith, 1948, Diethylstilbestrol in the prevention and treatment of complications of pregnancy, Am J Obstet Gynecol, 56, 821, 10.1016/0002-9378(48)90440-2
Smith, 1954, Prophylactic hormone therapy relation to complications of pregnancy, Obstet Gynecol, 4, 129
Plate, 1954, Diethylstilbestrol therapy in habitual abortion, 751
Ross, 1953, Further report on the use of diethylstilbestrol in the treatment of threatened abortion, J Natl Med Assoc, 45, 223
Davis, 1950, Steroids in the treatment of early pregnancy complications, JAMA, 142, 778, 10.1001/jama.1950.02910290006002
Block, 1975, Non-evaluable patients in clinical cancer research, Cancer, 36, 1169, 10.1002/1097-0142(197509)36:3<1169::AID-CNCR2820360352>3.0.CO;2-D
Gehan, 1980, Use of prognostic factors in analysis of historical control studies, Cancer Treat Rep, 64, 373
Freiman, 1978, The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial, N Engl Med, 299, 690, 10.1056/NEJM197809282991304