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Meta-Analysis
. 2008 Jul 16;2008(3):MR000009.
doi: 10.1002/14651858.MR000009.pub4.

Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate

Gunn Elisabeth Vist  1 , Dianne Bryant, Lyndsay Somerville, Trevor Birminghem, Andrew D Oxman
Affiliations
Meta-Analysis

Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate

Gunn Elisabeth Vist et al. Cochrane Database Syst Rev. .

Abstract

Background: Some people believe that patients who take part in randomised controlled trials (RCTs) face risks that they would not face if they opted for non-trial treatment. Others think that trial participation is beneficial and the best way to ensure access to the most up-to-date physicians and treatments. This is an updated version of the original Cochrane review published in Issue 1, 2005.

Objectives: To assess the effects of patient participation in RCTs ('trial effects') independent both of the effects of the clinical treatments being compared ('treatment effects') and any differences between patients who participated in RCTs and those who did not. We aimed to compare similar patients receiving similar treatment inside and outside of RCTs.

Search strategy: In March 2007, we searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, The Cochrane Methodology Register, SciSearch and PsycINFO for potentially relevant studies. Our search yielded 7586 new references. In addition, we reviewed the reference lists of relevant articles.

Selection criteria: Randomized studies and cohort studies with data on clinical outcomes of RCT participants and similar patients who received similar treatment outside of RCTs.

Data collection and analysis: At least two review authors independently assessed studies for inclusion, assessed study quality and extracted data.

Main results: We identified 30 new non-randomized cohort studies (45 comparisons): no new RCTs were found. This update now includes five RCTs (yielding 6 comparisons) and 80 non-randomized cohort studies (130 comparisons), with 86,640 patients treated in RCTs and 57,205 patients treated outside RCTs. In the randomised studies, patients were invited to participate in an RCT or not; these comparisons provided limited information because of small sample sizes (a total of 412 patients) and the nature of the questions they addressed. When the results of RCTs and non-randomized cohorts that reported dichotomous outcomes were combined, there were 98 comparisons; there was also heterogeneity (P < 0.00001, I(2) = 42.2%) between studies. No statistical significant differences were found for 85 of the 98 comparisons. Eight comparisons reported statistically significant better outcomes for patients treated within RCTs, and five comparisons reported statistically significant worse outcomes for patients treated within RCTs. There was significant heterogeneity (P < 0.00001, I(2) = 58.2%) among the 38 continuous outcome comparisons. No statistically significant differences were found for 30 of the 38 comparisons. Three comparisons reported statistically significant better outcomes for patients treated within RCTs, and five comparisons reported statistically significant worse outcomes for patients treated within RCTs.

Authors' conclusions: This review indicates that participation in RCTs is associated with similar outcomes to receiving the same treatment outside RCTs. These results challenge the assertion that the results of RCTs are not applicable to usual practice.

PubMed Disclaimer

Conflict of interest statement

None known

Figures

1.1
1.1. Analysis
Comparison 1 All in RCTs versus all out of RCTs, dichotomous, Outcome 1 Main outcome, dichotomous.
2.1
2.1. Analysis
Comparison 2 All in RCTs versus all out of RCTs, continuous, Outcome 1 Main outcome, continuous scale.
3.1
3.1. Analysis
Comparison 3 Mortality, Outcome 1 Mortality.
See this image and copyright information in PMC

Update of

References

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    1. Nicolaides K, Brizot MdL, Patel F, Snijders R. Comparison of chorionic villus sampling and amniocentesis for fetal karyotyping at 10‐13 weeks' gestation. Lancet 1994;344:435‐9. - PubMed
Nicolaides 1994b {published data only}
    1. Nicolaides K, Brizot MdL, Patel F, Snijders R. Comparison of chorionic villus sampling and amniocentesis for fetal karyotyping at 10‐13 weeks' gestation. Lancet 1994;334:435‐9. - PubMed
Ogden 2004 {published data only}
    1. Ogden JA, Alvarez RG, Levitt RL, Johnson JE, Marlow ME. Electrohydraulic high‐energy shock‐wave treatment for chronic plantar fasciitis. Journal of Bone and Joint Surgery 2994;86:2216‐28. - PubMed
Paradise 1984a {published and unpublished data}
    1. Paradise JL, Bluestone CD, Bachman RZ, Colborn DK, Bernard BS, Taylor FH, et al. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized clinical trials. The New England Journal of Medicine 1984;310:674‐83. - PubMed
Paradise 1984b {published and unpublished data}
    1. Paradise JL, Bluestone CD, Bachman RZ, Colborn DK, Bernard BS, Taylor FH, Rogers KD, Schwarzbach RH, Stool SE, Friday GA, Smith IH, Saez CA. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized clinical trials. The New England Journal of Medicine 1984;310:674‐83. - PubMed
Paradise 1990a {published and unpublished data}
    1. Paradise JL, Bluestone CD, Rogers KD, Taylor FH, Colborn DK, Bachman RZ, et al. Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy‐tube replacement. Results of parallel randomized and nonrandomized trials. Journal of the American Medical Association 1990;263:2066‐73. - PubMed
Paradise 1990b {published and unpublished data}
    1. Paradise JL, Bluestone CD, Rogers KD, Taylor FH, Colborn DK, Bachman RZ, et al. Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy‐tube replacement. Results of parallel randomized and nonrandomized trials. Journal of the American Medical Association 1990;263:2066‐73. - PubMed
Playforth 1988 {published and unpublished data}
    1. Playforth MJ, Smith GMR, Evans M, Pollock AV. Antimicrobial bowel preparation. Oral, parenteral, or both?. Diseases Colon and Rectum 1988;31:90‐3. - PubMed
Raistrick 2005a {published data only}
    1. Raistrick D, West D, Finnegan O, Thistlethwaite G, Brearley R, Banbery J. A comparison of buprenorphine and lofexidine for community opiate detoxification: results from a randomized controlled trial. Addiction 2005;100:1860‐7. - PubMed
Raistrick 2005b {published data only}
    1. Raistrick D, West D, Finnegan O, Thistlethwaite G, Brearley R, Banbery J. A comparison of buprenorphine and lofexidine for community opiate detoxification: results from a randomized controlled trial. Addiction 2005;100:1860‐7. - PubMed
Reeves 2004 {published data only}
    1. Reeves BC, Angelini GD, Bryan AJ, Taylor FC, Cripps T, Spyt TJ, et al. A multi‐centre randomised controlled trial of minimally invasive direct coronary bypass grafting versus percutaneous transluminal coronary angioplasty with stenting for proximal stenosis of the left anterior descending coronary artery. Health Technology Assessment 2004;8(16):57p. - PubMed
Rigg 2000a {published and unpublished data}
    1. Rigg JRA, Jamrozik K, Myles PS, Silbert B, Peyton P, Parsons RW, et al. Design of the multicenter Australian study of epidural anesthesia and analgesia in major surgery: The MASTER trial. Controlled Clinical Trials 2000;21:244‐56. - PubMed
Rigg 2000b {published and unpublished data}
    1. Rigg JRA, Jamrozik K, Myles PS, Silbert B, Peyton P, Parsons RW, et al. Design of the multicenter Australian study of epidural anesthesia and analgesia in major surgery: The MASTER trial. Controlled Clinical Trials 2000;21:244‐56. - PubMed
Rosen 1987a {published data only}
    1. Rosen MA, Roizen MF, Eger II EI, Glass RH, Martin M, Dandekar PV, et al. The effect of nitrous oxide on in vitro fertilization success rate. Anesthesiology 1987;67:42‐4. - PubMed
Rosen 1987b {published data only}
    1. Rosen MA, Roizen MF, Eger II EI, Glass RH, Martin M, Dandekar PV, et al. The effect of nitrous oxide on in vitro fertilization success rate. Anesthesiology 1987;67:42‐4. - PubMed
Rovers 2001a {published and unpublished data}
    1. Rovers MM, Straatman H, Ingels K, Wilt GJ, Broek P, Zielhuis GA. Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting. Journal of Clinical Epidemiology 2001;54:789‐94. - PubMed
Rovers 2001b {published and unpublished data}
    1. Rovers MM, Straatman H, Ingels K, Wilt GJ, Broek P, Zielhuis GA. Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting. Journal of Clinical Epidemiology 2001;54:789‐94. - PubMed
Rørbye 2005a {published data only}
    1. Rørbye C, Nørgaard M, Nilas L. Medical versus surgical abortion: comparing satisfaction and potential confounders in a partly randomized study. Human Reproduction 2005;20:834‐8. - PubMed
Rørbye 2005b {published data only}
    1. Rørbye C, Nørgaard M, Nilas L. Medical versus surgical abortion: comparing satisfaction and potential confounders in a partly randomized study. Human Reproduction 2005;20:834‐8. - PubMed
Schmoor 1996a {published and unpublished data}
    1. Schmoor C, Oleschewski M, Schumacher M. Randomized and non‐randomized patients in clinical trials: Experiences with comprehensive cohort studies. Statistics in Medicine 1996;15:263‐71. - PubMed
Schmoor 1996b {published and unpublished data}
    1. Schmoor C, Oleschewski M, Schumacher M. Randomized and non‐randomized patients in clinical trials: Experiences with comprehensive cohort studies. Statistics in Medicine 1996;15(263‐71). - PubMed
Schmoor 1996c {published and unpublished data}
    1. Schmoor C, Oleschewski M, Schumacher M. Randomized and non‐randomized patients in clinical trials: Experiences with comprehensive cohort studies. Statistics in Medicine 1996;15:263‐71. - PubMed
Schmoor 1996d {published and unpublished data}
    1. Schmoor C, Oleschewski M, Schumacher M. Randomized and non‐randomized patients in clinical trials: Experiences with comprehensive cohort studies. Statistics in Medicine 1996;15:263‐71. - PubMed
Schmoor 1996e {published and unpublished data}
    1. Schmoor C, Oleschewski M, Schumacher M. Randomized and non‐randomized patients in clinical trials: Experiences with comprehensive cohort studies. Statistics in Medicine 1996;15:263‐71. - PubMed
Schmoor 1996f {published and unpublished data}
    1. Schmoor C, Oleschewski M, Schumacher M. Randomized and non‐randomized patients in clinical trials: Experiences with comprehensive cohort studies. Statistics in Medicine 1996;15:263‐71. - PubMed
Strandberg 1995 {published and unpublished data}
    1. Strandberg TE, Salomaa VV, Vanhanen HT, Naukkarin VA, Sarna AJ, Miettinen TA. Mortality in participants and non‐participants of a multifactorial prevention study of cardiovascular diseases: A 28 year follow up of the Helsinki businessmen study. British Heart Journal 1995;74:449‐54. - PMC - PubMed
Sullivan 1982a {published data only}
    1. Sullivan MP, Fuller LM, Chen T, Fisher R, Fryer C, Gehan E, et al. Intergroup Hodgkin's disease in children study of stages I and II: A preliminary report. Cancer Treatment Reports 1982;66:937‐47. - PubMed
Sullivan 1982b {published data only}
    1. Sullivan MP, Fuller LM, Chen T, Fisher R, Fryer C, Gehan E, et al. Intergroup Hodgkin's disease in children study of stages I and II: A preliminary report. Cancer Treatment Reports 1982;66:937‐47. - PubMed
Sullivan 1982c {published data only}
    1. Sullivan MP, Fuller LM, Chen T, Fisher R, Fryer C, Gehan E, et al. Intergroup Hodgkin's disease in children study of stages I and II: A preliminary report. Cancer Treatment Reports 1982;66:937‐47. - PubMed
Urban 1999 {published data only}
    1. Urban P, Stauffer J‐C, Bleed D, Khatchatrian N, Amann W, Bertel O, et al. A randomized evaluation of early revascularization to treat shock complicating acute myocardial infarction. European Heart Journal 1999;20:1030‐8. - PubMed
Villamaria 1997a {published and unpublished data}
    1. Villamaria FJ, Baisden CE, Hillis A, Rajab MH, Rinaldi PA. Forced‐air warming is no more effective than conventional methods for raising postoperative core temperature after cardiac surgery. Journal of Cardiothoracic and Vascular Anesthesia 1997;11:708‐11. - PubMed
Villamaria 1997b {published and unpublished data}
    1. Villamaria FJ, Baisden CE, Hillis A, Rajab MH, Rinaldi PA. Forced‐air warming is no more effective than conventional methods for raising postoperative core temperature after cardiac surgery. Journal of Cardiothoracic and Vascular Anesthesia 1997;11:708‐11. - PubMed
Waard 2002a {published data only}
    1. Waard MW, Vos J, Bonsel GJ, Bindels PJE, Ankum WM. Management of miscarriage: a randomized controlled trial of expectant mangement versus surgical evaluation. Human Reproduction 2002;17:2445‐50. - PubMed
Waard 2002aa {published data only}
    1. Waard MW, Vos J, Bonsel GJ, Bindels PJE, Ankum WM. Management of miscarriage: a randomized controlled trial of expectant mangement versus surgical evaluation. Human Reproduction 2002;17:2445‐50. - PubMed
Walker 1986 {published data only}
    1. Walker WS, Raychaudhury T, Faichney A, Prescott RJ, Tonkin RW, Sang CTM, Cameron EWJ, Reid KG, Walbaum PR. Wound colonisation following cardiac surgery. Journal Cardiovascular Surgery 1986;27:662‐6. - PubMed
Wallage 2003 {published data only}
    1. Wallage S, Cooper KG, Graham WJ, Parkin DE. A randomised trial comparing local versus general anaesthesia for microwave endometrial ablation. BJOG 2003;10:799‐807. - PubMed
Wetzner 1979 {published data only}
    1. Wetzner SM, Vincent ME, Robbins AH. Ceruletide‐assisted cholecystography: A clinical assessment. Radiology 1979;131:23‐6. - PubMed
Wikdahl 1992 {published and unpublished data}
    1. Wikdahl AM, Granbom L, Stegmayr BG. CAPD bag changing with integrated disconnect system gives lower incidence of peritonitis than with UV‐box system. Advances in Peritoneal Dialysis 1992;8:276‐80. - PubMed
Williford 1993 {published data only}
    1. Williford WO, Krol WF, Buzby GP. Comparison of eligible randomized patients with two groups of ineligible patients: can the results of the VA total parenteral nutrition clinical trial be generalized?. Journal of Clinical Epidemiology 1993;46:1025‐34. - PubMed
Witt 2006a {published data only}
    1. Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with osteoarthritis of the knee or hip. Arthritis & Rheumatism 2006;54:3485‐93. - PubMed
Witt 2006b {published data only}
    1. Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture for patients with chronic neck pain. Pain 2006;125:98‐106. - PubMed
Witt 2006c {published data only}
    1. Witt CM, Jena S, Selim D, Brinkhaus B, Reinhold T, Wruck K, et al. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. American Journal of Epidemiology 2006;164:487‐96. - PubMed
Yamamoto 1992a {published data only}
    1. Yamamoto H, Hughes RW, Schroeder KW, Viggiano TR, DiMagno EP. Treatment of benign esophageal stricture by Eder‐Puestow or balloon dilators: A comparison between randomized and prospective nonrandomized trials. Mayo Clinic Proc 1992;67:228‐36. - PubMed
Yamamoto 1992b {published data only}
    1. Yamamoto H, Hughes RW, Schroeder KW, Viggiano TR, DiMagno EP. Treatment of benign esophageal stricture by Eder‐Puestow or balloon dilators: A comparison between randomized and prospective nonrandomized trials. Mayo Clinic Proc 1992;67:228‐36. - PubMed
Yamani 2005 {published data only}
    1. Yamani MH, Avery R, Mawhorter SD, McNeill A, Cook D, Ratliff NB, et al. The impact of cytgam on cardiac transplant recipients with moderate hypogammaglobulinemia: A randomized single‐center study. Journal Heart and Lung Transplant 2005;24:1766‐9. - PubMed
Yersin 1996 {published data only}
    1. Yersin B, Besson J, Duc‐Mingot S, Burnand B. Screening and referral of alcoholic patients in a general hospital. A clinical trial. European Addiction Research 1996;2:94‐101.
Young 1996 {published data only}
    1. Young JDH, MacEwen CJ, Ogston SA. Congenital nasolacrimal duct obstruction in the second year of life: A multicentre trial of management. Eye 1996;10:485‐91. - PubMed

References to studies excluded from this review

Akaza 1995 {published data only}
    1. Akaza H, Hinotsu S, Aso Y, Kakizoe T, Koiso K. Bacillus Calmette‐Guerin treatment of existing papillary bladder cancer and carcinoma in situ of the bladder. Four‐year results. The Bladder Cancer BCG Study Group. Cancer 1995;75(2):552‐9. - PubMed
Albert 1997 {published and unpublished data}
    1. Albert SM, Sano M, Marder K, Jacobs DM, Brandt J, Albert M, et al. Participation in clinical trials and long‐term outcomes in Alzheimer's disease. Neurology 1997;49:38‐43. - PubMed
Amadori 1993 {published data only}
    1. Amadori S, Testi AM, Arico M, Comelli A, Giuliano M, Madon E, et al. Prospective comparative study of bone marrow transplantation and postremission chemotherapy for childhood acute myelogenous leukemia. Journal of Clinical Oncology 1993;11:1046‐54. - PubMed
Ashok 2002 {published data only}
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Azurin 1971 {published data only}
    1. Azurin JC, Alvero M. Cholera Incidence in a population offered Cholera vaccination: Comparison of cooperative and uncooperative groups. Bulletin World Health Organisation 1971;44:815‐9. - PMC - PubMed
Bahit 2003 {published data only}
    1. Bahit MC, Cannon CP, Antman EM, Murphy SA, Gibson CM, McCabe CH, et al. Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry. American Heart Journal 2003;145(1):109‐17. - PubMed
Banach 2000 {published data only}
    1. Banach MJ, Ferrone PJ, Trese MT. A comparison of dense versus less dense diode laser photocoagulation patterns for threshold retinopathy of prematurity. Ophthalmology 2000;107:324‐8. - PubMed
Bangstad 1992 {published data only}
    1. Bangstad HJ, Kofoed‐Enevoldsen A, Dahl‐Jorgensen K, Hanssen KF. Glomerular charge selectivity and the influence of improved blood glucose control in type 1 (insulin‐dependent) diabetic patients with microalbuminuria. Diabetologia 1992;35(12):1165‐9. - PubMed
Barnett 1992 {published and unpublished data}
    1. Barnett BJ, Parfrey PS, Vavasour HM, McDonald J, Kent G, Hefferton D, et al. Contrast nephropathy in patients with impared renal function: High versus low osmolar media. Kidney International 1992;41:1274‐9. - PubMed
Bartalena 1983 {published and unpublished data}
    1. Bartalena L, Marcocci C, Chiovato L, Laddaga M, Lepri G, Andreani D, Cavallacci G, Baschieri L, Pinchera A. Orbital cobalt irradiation combined with systemaic corticosteroids for Graves' ophthalmopathy: Comparison with systemic corticosteroids alone. Journal of Clinical Endocrinology and Metabolism 1983;56:1139‐44. - PubMed
Behar 1975 {published data only}
    1. Behar J, Sheahan DG, Biancani P, Spiro HM, Storer EH. Medical and surgical management of reflux esophagitis. A 38‐month report of a prospective clinical trial. The New England Journal of Medicine 1975;293:263‐8. - PubMed
Bertelsen 1991 {published data only}
    1. Bertelsen K. Protocol allocation and exclusion in two Danish randomised trials in ovarian cancer. British Journal of Cancer 1991;64:1172‐6. - PMC - PubMed
Bertelsen 1994 {published data only}
    1. Bertelsen K, Andersen JE. Long‐term survival and prognostic factors in advanced epithelial ovarian cancer with special emphasis upon the effects of protocol inclusion. International Journal of Gynecological Cancer 1994;4:180‐7. - PubMed
Bifano 1994 {published data only}
    1. Bifano EM, Miggiani WP, Parker PR. Impact of transfusion guidelines on transfusion practices in premature infants. Pediatric Research 1994;35:216A.
Birch 1992 {published data only}
    1. Birch EE, Birch DG, Hoffman DR, Uauy R. Dietary essential fatty acid supply and visual acuity development. Investigative Ophthalmology & Visual Science 1992;33(11):3242‐53. - PubMed
Black 1993 {published and unpublished data}
    1. Black SB, Shinefield HR, Ray P, Lewis EM, Fireman B, Hiatt R, et al. Safety of combined oligosaccharide conjugate Haemophilus influenzae type b (HbOC) and whole cell diphtheria‐tetanus toxoids‐pertussis vaccine in infancy. Pediatric Infectious Diseases Journal 1993;12:981‐5. - PubMed
Boros 1985 {published and unpublished data}
    1. Boros L, Chuang C, Butler FO, Bennett JM. Leukemia in Rochester (NY). A 17‐year experience with an analysis of the role of cooperative group (ECOG) participation. Cancer 1985;56:2161‐9. - PubMed
Bouchet 1996 {published and unpublished data}
    1. Bouchet C, Guillemin F, Briancon S. Nonspecific effects of longitudinal studies: Impact on quality of life measures. Journal of Clinical Epidemiology 1996;49:15‐20. - PubMed
Brower 2000 {published data only}
    1. Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The New England Journal of Medicine 2000;342:1301‐8. - PubMed
Brown 1981 {published and unpublished data}
    1. Brown CA, Hutter AM, DeSanctis RW, Gold HK, Leinbach RC, Robert_niles A, Austen WG, Buckley MJ. Prospective study of medical and urgent surgical therapy in randomizable patients with unstable angina pectoris: Results of in‐hospital and chronic mortallity and morbidity. American Heart Journal 1981;102:959‐64. - PubMed
Brown 1999 {published data only}
    1. Brown N, Melville M, Gray D, Young T, Skene AM, Wilcox RG, et al. Relevance of clinical trial results in myocardial infarction to medical practice: comparison of four year outcome in participants of a thrombolytic trial, patients receiving routine thrombolysis, and those deemed ineligible for trombolysis. Hearth 1999;81:598‐602. - PMC - PubMed
Browne 1990 {published data only}
    1. Browne MJ, Potter D, Gress J, Cotton D, Hiemenz J, Thaler M, et al. A randomized trial of open lung biopsy versus empiric antimicrobial therapy in cancer patients with diffuse pulmonary infiltrates. Journal of Clinical Oncology 1990;8:222‐9. - PubMed
Canfield 1977 {published data only}
    1. Canfield R, Rosner W, Skinner J, McWhorter J, Resnick L, Feldman F, et al. Diphosphonate therapy of Paget's disease of the bone. Journal of Clinical Endocrinological Metabolism 1977;44:96‐106. - PubMed
Caplan 1984 {published data only}
    1. Caplan DB, Buchanan CN. Treatment of lower respiratory tract infections due to pseudomonas aeruginosa in patients with cystic fibrosis. Reviews of Infectious Diseases 1984;6:S705‐10. - PubMed
Carroll 1999 {published and unpublished data}
    1. Carroll KM, Nich C, McLellan AT, McKay JR, Rounsaville BJ. 'Research' versus 'real‐world' patients: representativeness of participants in clinical trials of treatments for cocaine dependence. Drug and Alcohol Dependence 1999;54:171‐7. - PubMed
Chadwick 1991 {published and unpublished data}
    1. Chadwick DW. A randomized study of antiepilectic drug withdrawl in patients in remission of epilepsy. Boll Lega It Epil 1991;75/76:29‐36.
Chaitman 1986 {published data only}
    1. Chaitman BR, Davis KB, Kaiser GC, Mudd G, Wiens RD, Ng GS, et al. The role of coronary bypass surgery for 'left main equivalent' coronary disease: The coronary artery surgery study registry. Circulation 1986;74 S III:III‐17‐25. - PubMed
Chaitman 1990 {published data only}
    1. Chaitman BR, Ryan TJ, Kronmal RA, Foster ED, Frommer PL, Killip T, et al. Coronary artery surgery study (CASS): Comparability of 10 year survival in randomized and randomizable patients. Journal of the American College of Cardiology 1990;16:1071‐8. - PubMed
Chen 2000 {published data only}
    1. Chen CI, Skingley P, Meyer RM. A comparison of elderly patients with aggressive histology lymphoma who were entered or not entered on to a randomised phase II trial. Leukemia and Lymphoma 2000;38:327‐34. - PubMed
Clemens 1992 {published data only}
    1. Clemens JD, Loon FFPL, Rao M, Sack DA, Ahmed F, Chakraborty J, et al. Nonparticipation as a determinant of adverse health outcomes in a field of oral cholera vaccines. American Journal of Epidemiology 1992;135:865‐74. - PubMed
Cohen 1983 {published data only}
    1. Cohen CJ, Goldberg JD, Holland JF, Bruckner HW, Deppe G, Gusberg SB, et al. Improved therapy with cisplatin regimens for patients with ovarian carcinoma (FIGO Stages III and IV) as measured by surgical end‐staging (second‐look operation). American Journal of Obstertrics and Gynecology 1983;145:955‐67. - PubMed
Cooper 1999 {published data only}
    1. Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA, Al‐Sarraf M, et al. Chemoradiotherapy of locally advanced esophageal cancer. Long‐term follow‐up of a prospective randomized trial (RTOG 85‐01). Journal of the American Medical Association 1999;281:1623‐7. - PubMed
Cottin 1999 {published data only}
    1. Cottin V, Arpin D, Lasset C, Cordier J‐F, Brune J, Chauvin F, et al. Small‐cell lung cancer: Patients included in clinical trials are not representative of the patient population as a whole. Annals of Oncology 1999;10:809‐15. - PubMed
Cunningham 1989 {published data only}
    1. Cunningham AJ, Tocco EK. A randomized trial of group psychoeducational therapy for cancer patients. Patient Education and Counseling 1989;14:101‐14.
Cutlip 2001 {published data only}
    1. Cutlip DE, Baim DS, Ho KKL, Popma JJ, Lansky AJ, Cohen DJ, et al. Stent thrombosis in the modern era: A pooled analysis of multicenter coronary stent clinical trials. Circulation 2001;103:1967‐71. - PubMed
Dahlberg 1999 {published data only}
    1. Dahlberg M, Glimelius B, Påhlman L. Improved survival and reduction in local failure rates after preoperative radiotherapy. Evidence for the generalizability of the results of Swedish rectal cancer trial. Annals of Surgery 1999;229:493‐7. - PMC - PubMed
Davis 1988 {published data only}
    1. Davis K. The comprehensive cohort study: The use of registry data to confirm and extend a randomized trial. Recent results in cancer research 1988;111:138‐48. - PubMed
Decensi 2003 {published data only}
    1. Decensi A, Robertson C, Viale G, Pigatto F, Johansson H, Kisanga ER, et al. A randomized trial of low‐dose tamoxifen on breast cancer proliferation and blood estrogenic biomarkers. Journal of the National Cancer Institute 2003;95(11):779‐90. - PubMed
Detre 1999 {published data only}
    1. Detre KM, Guo P, Holubkov R, Califf RM, Sopko G, Bach R, et al. Coronary revascularization in diabetic patients: A comparison of the randomized and observational components of the bypass angioplasty revascularization investigation (BARI). Circulation 1999;99:633‐40. - PubMed
Deuschle 2004 {published data only}
    1. Deuschle M, Krumm B, Bindeballe N, Colla M, Hamann B, Lederbogen F, et al. Open‐label non‐randomized versus double‐blind randomized antidepressive treatment: what are the advantages of clinical decision over randomization?. Pharmacopsychiatry 2004;37(6):299‐302. - PubMed
Devine 1973 {published data only}
    1. Devine DA, Fernald PS. Outcome effects of receiving a preferred, randomly assigned, or nonpreferred therapy. Journal of Counseling and Clinical Psychology 1973;41:104‐7. - PubMed
Diehl 1995 {published data only}
    1. Diehl V, Loeffler M, Pfreundschuh M, Ruehl U, Hasenclever D, Nister‐Backes H, et al. Further chemotherapy versus low‐dose involved field radiotherapy as consolidation of complete remission after six cycles of alternating chemotherapy in patients with advanced Hodgkin's disease. Annals of Oncology 1995;6:901‐10. - PubMed
Exner 1999 {published data only}
    1. Exner DV, Reiffel JA, Epstein AE, Ledingham R, Reiter MJ, YAo Q, et al. Beta‐blocker use and survival in patients with ventricular fibrillation or symptomatic ventricular tachycardia: The antiarrhytmics versus implantable defibrillators (AVID) trial. Journal of American College of Cardiology 1999;34:325‐33. - PubMed
Fossa 2002 {published data only}
    1. Fossa SD, Skovlund E. Selection of patients may limit the generalizability of results from cancer trials. Acta Oncologica 2002;41(2):131‐7. - PubMed
Franz 1995 {published data only}
    1. Franz MJ, Monk A, Barry B, McClain K, Weaver T, Cooper N, et al. Effectiveness of medical nutrition therapy provided by dietitians in the management of non‐insulin‐dependent diabetes mellitus: a randomized, controlled clinical trial. Journal of the American Dietetic Association 1995;95(9):1009‐17. - PubMed
Frazee 1996 {published data only}
    1. Frazee RC, Roberts JW, Symmonds RE, Snyder SK, Hendricks JC, Smith RW, et al. Open versus stereotactic breast biopsy. The American Journal of Surgery 1996;172:491‐5. - PubMed
Frucht‐Pery 2006 {published data only}
    1. Frucht‐Pery J, Raiskup F, Ilsar M, Landau D, Orucov F, Solomon A. Conjunctival autografting combined with low‐dose mitomycin C for prevention of primary pterygium recurrence. American Journal of Ophthalmology 2006;141(6):1044‐50. - PubMed
GBSG 1995 {published data only}
    1. The German Breast Cancer Study Group (GBSG). Therapy of small breast cancer ‐ Four‐year results of a prospective non‐randomised study. Breast Cancer Research and Treatment 1995;34:1‐13. - PubMed
Gonwa 2002 {published data only}
    1. Gonwa TA, Hricik DE, Brinker K, Grinyo JM, Schena FP, Sirolimus Renal Function Study Group. Improved renal function in sirolimus‐treated renal transplant patients after early cyclosporine elimination. Transplantation 2002;74(11):1560‐7. - PubMed
Gossop 1986 {published data only}
    1. Gossop M, Johns A, Green L. Opiate withdrawl: Inpatient versus outpatient programmes and preferred versus random assignment to treatment. British Medical Journal 1986;293:103‐4. - PMC - PubMed
Groff 2004 {published data only}
    1. Groff A, Burns B, Swanson J, Swartz M, Wagner HR, Tompson M. Caregiving for persons with mental illness: the impact of outpatient commitment on caregiving strain. Journal of Nervous & Mental Disease 2004;192(8):554‐62. - PubMed
Haberkern 1997 {published data only}
    1. Haberkern CM, Neumayr LD, Orringer EP, Earles AN, Robertson SM, Black D, et al. Cholecystectomy in sickle cell anemia patients: Perioperative outcome of 364 cases from the national preoperative transfusion study. Blood 1997;5:1533‐42. - PubMed
Hauth 1983 {published data only}
    1. Hauth JC, Gilstrap LC, Brekken AL, Hauth JM. The effect of 17a‐hydroxyprogesterone caproate on pregnancy outcome in an active‐duty military population. American Journal of Obstetrics and Gynecology 1983;146:187‐9. - PubMed
Hertegard 2002 {published data only}
    1. Hertegard S, Hallen L, Laurent C, Lindstrom E, Olofsson K, Testad P, et al. Cross‐linked hyaluronan used as augmentation substance for treatment of glottal insufficiency: safety aspects and vocal fold function. Laryngoscope 2002;112(12):2211‐9. - PubMed
Hjorth 1992 {published data only}
    1. Hjorth M, Holmberg E, Rodjer S, Westin J for the myeloma group of western Sweden. Impact of active and passive exclusions on the results of a clinical trial in multiple myeloma. British Journal of Hematology 1992;80:55‐61. - PubMed
Hoh 1998 {published data only}
    1. Hoh R, Pelfini A, Neese RA, Chan M, Cello JP, Cope FO, et al. De novo lipogenesis predicts short‐term body‐composition response by bioelectrical impedance analysis to oral nutritional supplements in HIV‐associated wasting. American Journal of Clinical Nutrition 1998;68(1):154‐63. - PubMed
Holubkov 1999 {published data only}
    1. Holubkov R, Detre KM, for the bypass Angioplasty revascularization investigation (BARI) researchers. Differences in 5‐year outcome for BARI trial and registry diabetics. Diabetes 1999;16:27‐31.
Jack 1990 {published data only}
    1. Jack WJL, Chetty U, Rodger A. Recruitment to a prospective breast conservation trial: Why are so few patients randomised?. British Medical Journal 1990;301:83‐5. - PMC - PubMed
Jensen 1996 {published and unpublished data}
    1. Jensen LP, Nielsen OM, Schroeder TV. The importance of complete follow‐up for results after femoro‐infrapopliteal vascular surgery. European Journal of Vascular and Endovascular Surgery 1996;12:282‐6. - PubMed
Jeremic 1999 {published data only}
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Julien 2000 {published data only}
    1. Julien J‐P, Bijker N, Fentiman IS, Peterse JL, Delledonne V, Rouanet P, et al. Radiotherapy in breast‐conserving treatment for ductal carcinoma in situ: First results of the EORTC randomised phase III trial 10853. The Lancet 2000;355:528‐33. - PubMed
Kahan 2000 {published data only}
    1. Kahan BD, for The Rapamune US Study Group. Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: A randomized multicentre study. The Lancet 2000;356:194‐202. - PubMed
Kamal 2006 {published data only}
    1. Kamal SM, Moustafa KN, Chen J, Fehr J, Abdel MA, Khalifa KE, et al. Duration of peginterferon therapy in acute hepatitis C: a randomized trial.[see comment][erratum appears in Hepatology. 2006 Oct;44(4):1055]. Hepatology 2006;43(5):923‐31. - PubMed
Karande 1997 {published data only}
    1. Karande V, Korn A, Morris R, Rao R, Balin M, Rinehart J, et al. A prospective randomized trial, assessing outcome and cost of IVF as a first choice treatment versus a traditional infertility treatment algorithm. 1997:S41. - PubMed
Kober 1995 {published data only}
    1. Kober L, Torp‐Pedersen C, on behalf of the TRACE study group. Clinical characteristics and mortality of patients screened for entry into the trandolapril cardiac evaluation (TRACE) study. American Journal of Cardiology 1995;76:1‐5. - PubMed
Kober 2000 {published data only}
    1. Kober L, Thomsen PEB, Moller M, Torp‐Pedersen C, Carlsen J, Sandoe E, et al. Effect of dofetilide in patients with recent myocardial infarction and left‐ventricular dysfunction: A randomised trial. The Lancet 2000;356:2052‐8. - PubMed
Korvick 1992 {published and unpublished data}
    1. Korvick JA, Peacock JE, Muder RR, Wheeler RR, Yu VL. Addition of Rifampin to combination antibiotic therapy for Pseudomonas aeruginosa bacteria: Prospective trial using the Zelen protocol. Antimicrobial Agents and Chemotherapy 1992;36:620‐5. - PMC - PubMed
Lechner 1983 {published data only}
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Lennox 1979 {published data only}
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Libman 2000 {published data only}
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Licht 1997 {published and unpublished data}
    1. Licht RW, Gouliaev G, Vestergaard P, Frydenberg M. Generalisability of results from randomised drug trials. A trial on antimanic treatment. British Journal of Psychiatry 1997;170:264‐7. - PubMed
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Marsa‐Vila 1991 {published data only}
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Mayers 2001 {published and unpublished data}
    1. Mayers C, Panzarella T, Tannock IF. Analysis of the prognostic effects of inclusion in a clinical trial and of myelosuppression on survival after adjuvant chemotherapy for breast carcinoma. Cancer 2001;91:2246‐57. - PubMed
McAfee 2006 {published data only}
    1. McAfee PC, Geisler FH, Saiedy SS, Moore SV, Regan JJ, Guyer RD, et al. Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc. Spine 2006;31(11):1217‐26. - PubMed
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Meade 2000 {published data only}
    1. Meade TW, Brennan PJ, on behalf of the MRC General Practice Research Framework. Determination of who may derive most benefit from aspirin in primary prevention: Subgroup results from a randomised controlled trial. British Medical Journal 2000;321:13‐7. - PMC - PubMed
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Merlino 2001 {published and unpublished data}
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Mourits 2000 {published and unpublished data}
    1. Mourits M, Kempen‐Harteveld ML, Garcia MBG, Koppeschaar HPF Tick L, Terwee CB. Radiotherapy for Graves' orbitopathy: Randomised placebo‐controlled study. Lancet 2000;355:1505‐9. - PubMed
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    1. Peterson AC, Harlin H, Karrison T, Vogelzang NJ, Knost JA, Kugler JW, et al. A randomized phase II trial of interleukin‐2 in combination with four different doses of bryostatin‐1 in patients with renal cell carcinoma. Investigational New Drugs 2006;24(2):141‐9. - PubMed
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Ravindranath 1996 {published data only}
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Regan 2006 {published data only}
    1. Regan JJ, McAfee PC, Blumenthal SL, Guyer RD, Geisler FH, Garcia R, et al. Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charite Artificial Disc. Spine 2006;31(19):2270‐76. - PubMed
Rock 1992 {published data only}
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Rogers 1995 {published data only}
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Rokito 1996 {published and unpublished data}
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Rokke 1999 {published and unpublished data}
    1. Rokke PD, Tomhave JA, Jocic Z. The role of client choice and target selection in self‐management therapy for depression in older adults. Psychology and Aging 1999;14:155‐69. - PubMed
Rychtarik 1998 {published and unpublished data}
    1. Rychtarik RG, McGillicuddy NB, Connors GJ, Whitney RB. Participant selection biases in a randomized clinical trial of alcoholism treatment settings and intensities. Alcoholism: Clinical and Experimental Research 1998;22:969‐73. - PubMed
Schmidt 1999 {published data only}
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Sha 1995 {published and unpublished data}
    1. Sha BE, Benson CA, Pottage JC, Urbanski PA, Daugherty SR, Kessler HA. HIV infection in women: An observational study of clinical characteristics, disease progression, and survivial for a cohort of women in Chicago. Journal of Acquired Immune Deficiency Syndrome and Human Retrovirology 1995;8:486‐95. - PubMed
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Singh 1995 {published data only}
    1. Singh BN, Kehoe R, Woosley RL, Scheinman M, Quart B, and the Sotalol Multicenter Study Group. Multicenter trial of sotalol compared with procainamide in the supression of inducible ventricular tachycardia: A double blind, randomized parallel evaluation. American Hearth Journal 1995;129:87‐98. - PubMed
Singhal 2003 {published data only}
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Smith 1990 {published data only}
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Stiller 1989 {published and unpublished data}
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van Bergen 1995 {published and unpublished data}
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References to studies awaiting assessment

Adriaensen 2004 {published data only}
    1. Adriaensen MEAPM, Kock MCJM, Stijnen T, Sambeek MRHM, Urk H, Pattynama PMT, et al. Peripheral arterial disease: Therapeutic confidence of CT versus digital subtraction angiography and efffects on additional imaging recommendations. Radiology 2004;233:385‐91. - PubMed
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Beutel 2005 {published data only}
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Burgers 2002 {published data only}
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Campbell 2006 {published data only}
    1. Campbell M, Wileman S, Grant A, Ramsay C, Reflux Trial Group. The partially‐randomised patient‐preference design: lessons from the REFLUX Trial [abstract]. Clinical Trials 2006;3:203‐4.
Chiradejnant 2003 {published data only}
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COMSG 2003 {published data only}
    1. Collaborative Ocular Melanoma Study Group. Trends in size and treatment of recently diagnosed choroidal melanoma, 1987‐1997: findings from patients examined at collaborative ocular melanoma study (COMS) centers: COMS report no. 20. Archives of Ophthalmology 2003;121(8):1156‐62. - PubMed
Dickersin 2003 {published data only}
    1. Dickersin K, Munro M, Langenberg P, Scherer R, Frick KD, Weber AM, et al. Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP‐DUB): design and methods. Controlled Clinical Trials 2003;24(5):591‐609. - PubMed
Dutoit 2000 {published data only}
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Englund 2005 {published data only}
    1. Englund JA, Walter EB, Fairchok MP, Monto AS, Neuzil KM. A comparison of 2 influenza vaccine schedules in 6‐ to 23‐month‐old children. Pediatrics 2005;115(4):1039‐47. - PubMed
Feldon 2004 {published data only}
    1. Feldon SE. Computerized expert system for evaluation of automated visual fields from the Ischemic Optic Neuropathy Decompression Trial: Methods, baseline fields, and six‐month longitudinal follow‐up. Transactions of the American Ophthalmological Society 2004;102:269‐303. - PMC - PubMed
Feldon 2006 {published data only}
    1. Feldon SE, Levin L, Scherer RW, Arnold A, Chung SM, Johnson LN, et al. Development and validation of a computerized expert system for evaluation of automated visual fields from the Ischemic Optic Neuropathy Decompression Trial. BMC Ophthalmology 2006;6(34):1‐21. - PMC - PubMed
Hack 2003 {published data only}
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Jeffery 2003 {published data only}
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Kitchener 2004 {published data only}
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Koch‐Henriksen 2006 {published data only}
    1. Koch‐Henriksen N, Sørensen PS, Christensen T, Fredriksen J, Ravnborg M, Jensen K, et al. A randomized study of two interferon‐beta treatments in relapsing‐remitting multiple sclerosis. Neurology 2006;66:1056‐60. - PubMed
Krysztopik 2002 {published data only}
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Kudenchuk 1998 {published data only}
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References to other published versions of this review

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