Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma

Ophthalmic Epidemiology

Volumn 14, Issue 4, 2007, Pages 251-257

  Gilson, Marta M ^a,d   Diener West, Marie ^a,b,c   Hawkins, Barbara S ^a,b  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d NONE   (United States)

Author keywords

Clinical trials; Generalizability; National Death Index; Participation; Social Security Death Index

Indexed keywords

ADULT; CANCER RADIOTHERAPY; CANCER SURVIVAL; CHOROID MELANOMA; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ENUCLEATION; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; PRIORITY JOURNAL; PROGNOSIS; PROSPECTIVE STUDY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SURVIVAL TIME; TUMOR VOLUME;

BRACHYTHERAPY; CAUSE OF DEATH; CHOROID NEOPLASMS; ELIGIBILITY DETERMINATION; EYE ENUCLEATION; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; PATIENT PARTICIPATION; PROSPECTIVE STUDIES; SURVIVAL RATE; UNITED STATES;

EID: 34848840302     PISSN: 09286586     EISSN: 17445086     Source Type: Journal    
DOI: 10.1080/01658100701473275     Document Type: Conference Paper

References (26)

1. Antman K, Amato D, Wood W, Corson J, Suit H, Proppe K, Carey R, Greenberger J, Wilson R, Frei E 3rd. Selection bias in clinical trials. J Clin Oncol 1985 Aug;3(8):1142-1147.
2. Bahit MC, Cannon CP, Antman EM, Murphy SA, Gibson CM, McCabe CH, Braunwald E. 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. Am Heart J 2003 Jan;145(1):109-117.
3. Smith P, Arnesen H. Mortality in non-consenters in a postmyocardial infarction trial. J Intern Med 1990 Sep;228(3):253-256.
4. Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C. Threats to applicability of randomised trials: Exclusions and selective participation. J Health Serv Res Policy 1999 Apr;4(2):112-121.
5. Feuer EJ, Frey CM, Brawley OW, Nayfield SG, Cunningham JB, Geller NL, Bosl GJ, Kramer BS. After a treatment breakthrough: A comparison of trial and population-based data for advanced testicular cancer. J Clin Oncol 1994 Feb;12(2):368-377.
6. Vist GE, Hagen KB, Devereaux PJ, Bryant D, Kristoffersen DT, Oxman AD. Outcomes of patients who participate in randomised controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database of Methodology Reviews 2004; Issue 4. Art. No.: MR000009.
7. Collaborative Ocular Melanoma Study Group: Design and methods of a clinical trial for a rare condition: The Collaborative Ocular Melanoma Study. COMS Report No. 3. Controlled Clin Trials 1993 Oct;14(5):362-391.
8. Collaborative Ocular Melanoma Study Group. Sociodemographic and clinical predictors of participation in two randomized trials: Findings from the Collaborative Ocular Melanoma Study. COMS Report No. 7. Control Clin Trials 2001 Oct;22(5):526-537.
9. Collaborative Ocular Melanoma Study Group. The Collaborative Ocular Melanoma Study (COMS) randomized trial of preenucleation radiation of large choroidal melanoma I: Characteristics of patients enrolled and not enrolled. COMS Report No. 9. Am J Ophthalmol 1998 Jun;125(6):767-778.
10. Collaborative Ocular Melanoma Study Group: The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma. II. Characteristics of patients enrolled and not enrolled. COMS Report No. 17. Arch Ophthalmol 2001 Jul;119(7):951-965.
11. Chang AE, Karnell LH, Menck HR. The National Cancer Data Base report on cutaneous and noncutaneous melanoma: A summary of 84,836 cases from the past decade. The American College of Surgeons Commission on Cancer and the American Cancer Society. Cancer 1998 Oct 15;83(8):1664-1678.
12. Patel JK, Didolkar MS, Pickren JW, Moore RH. Metastatic pattern of malignant melanoma. A study of 216 autopsy cases. Am J Surg 1978 Jun;135(6):807-810.
13. Collaborative Ocular Melanoma Study Group. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS Report No. 15. Arch Ophthalmol. 2001 May;119(5):670-676.
14. Collaborative Ocular Melanoma Study Group. The Collaborative Ocular Melanoma Study (COMS) randomized trial of preenucleation radiation of large choroidal melanoma II: Initial mortality findings. COMS Report No. 10. Am J Ophthalmol 1998 Jun;125(6):779-796.
15. Collaborative Ocular Melanoma Study Group. The Collaborative Ocular Melanoma Study (COMS) randomized trial of preenucleation radiation of large choroidal melanoma: IV. Ten-year mortality findings and prognostic factors. COMS Report Number 24. Am J Ophthalmol 2004 Dec;138(6):936-951.
16. Collaborative Ocular Melanoma Study Group: The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: Initial mortality findings. COMS Report No. 18. Arch Ophthalmol 2001 Jul;119(7):969-982.
17. Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year mortality rates and prognostic factors: COMS Report No. 28. Arch Ophthalmol 2006 Dec;124(12):1684-1693.
18. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977 Mar;33(1):159-174.
19. Collett D. Modelling Survival Data in Medical Research London: Chapman and Hall, 1994; pp. 192-195.
20. McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 2003 Jul 16;290(3):360-366.
21. Davis KB, Fisher L, Gillespie MJ, Pettinger M. A test of the National Death Index using the Coronary Artery Surgery Study (CASS). Control Clin Trials. 1985 Sep;6(3):179-191.
22. Sesso HD, Gaziano JM, VanDenburgh M, Hennekens CH, Glynn RJ, Buring JE. Comparison of baseline characteristics and mortality experience of participants and nonparticipants in a randomized clinical trial: The Physicians' Health Study. Control Clin Trials 2002 Dec;23(6):686-702.
23. Semmens JB, Lawrence-Brown MM, Fletcher DR, Rouse IL, Holman CD. The Quality of Surgical Care Project: a model to evaluate surgical outcomes in Western Australia using population-based record linkage. Aust N Z J Surg 1998 Jun;68(6):397-403.
24. Olsen J, Melbye M, Olsen SF, Sorensen TI, Aaby P, Andersen AM, Taxbol D, Hansen KD, Juhl M, Schow TB, Sorensen HT, Andresen J, Mortensen EL, Olesen AW, Sondergaard C. The Danish National Birth Cohort-its background, structure and aim. Scand J Public Health 2001 Dec;29(4):300-307.
25. Sennerby U, Farahmand B, Ahlbom A, Ljunghall S, Michaelsson K. Cardiovascular diseases and future risk of hip fracture in women. Osteoporos Int 2007 May 10.
26. Tang ST, Chen ML, Huang EW, Koong SL, Lin GL, Hsiao SC. Hospice utilization in Taiwan by cancer patients who died between 2000 and 2004. J Pain Symptom Manage 2007 Apr;33(4):446-453.