Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial - Lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer) Data collection, quality, and reporting

BMC Medical Research Methodology

Volumn 15, Issue 1, 2015, Pages

  Williams, Naomi J ^a   Hill, Elizabeth M ^a   Ng, Siaw Yein ^a   Martin, Richard M ^a   Metcalfe, Chris ^a   Donovan, Jenny L ^a   Evans, Simon ^b   Hughes, Laura J ^c   Davies, Charlotte F ^a   Hamdy, Freddie C ^d   Neal, David E ^c   Turner, Emma L ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b ROYAL UNITED HOSPITAL   (United Kingdom)

^c UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Bias; Blinding; Endpoint review; Outcome assessors; Prostate cancer; Standardisation of information; Trial arm; Underlying cause of death; Verification

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

AGED; BLOOD; CAUSE OF DEATH; CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; EARLY CANCER DIAGNOSIS; ECONOMICS; GENERAL PRACTITIONER; HUMAN; MALE; MASS SCREENING; MEDICAL RECORD; METHODOLOGY; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PROCEDURES; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIAL; STANDARD; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED KINGDOM;

AGED; CAUSE OF DEATH; COST-BENEFIT ANALYSIS; EARLY DETECTION OF CANCER; GENERAL PRACTITIONERS; HUMANS; MALE; MASS SCREENING; MEDICAL RECORDS; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; REFERENCE STANDARDS; RESEARCH DESIGN; UNITED KINGDOM;

EID: 84929171841     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/1471-2288-15-6     Document Type: Article

References (26)

1. Miller AB, Yurgalevitch S, Weissfeld JL: Death review process in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial. Control Clin Trials 2000,21(6):400S-406S. 10.1016/S0197-2456(00)00095-7
2. De Koning HJ, Blom J, Merkelbach JW, Raaijmakers R, Verhaegen H, Van Vliet P, et al.: Determining the cause of death in randomized screening trial(s) for prostate cancer. BJU Int 2003, 92:71-78. 10.1111/j.1465-5101.2003.04402.x
3. Otto S, van Leeuwen P, Hoekstra J, Merckelbach J, Blom J, Schröder F, et al.: Blinded and uniform causes of death verification in cancer screening: A major influence on the outcome of a prostate cancer screening trial? Eur J Cancer 2010,46(17):3061-3067. 10.1016/j.ejca.2010.09.026
4. Horeweg N, Van Klaveren R, Groen H, Lammers JW, Weenink C, Nackaerts K, et al.: Blinded and uniform cause of death verification in a lung cancer CT screening trial. Lung Cancer 2012,77(3):522-525. 10.1016/j.lungcan.2012.04.018
5. Karch SB, Rutherford JD: Death certification in the UK. JRSM 2003,96(9):425-427. 10.1258/jrsm.96.9.425
6. Maudsley G, Williams E: Death certification by house officers and general practitioners - practice and performance. J Public Health 1993,15(2):192-201.
7. Maclaughlan J, Wells C: Death certification reform: a case study on the potential impact on mortality statistics, England and Wales. Off National Statistics Statistical Bull 2012.
8. Albertsen PC, Walters S, Hanley JA: A comparison of cause of death determination in men previously diagnosed with prostate cancer who died in 1985 or 1995. J Urol 2000,163(2):519-523. 10.1016/S0022-5347(05)67915-3
9. Newschaffer CJ, Otani K, McDonald MK, Penberthy LT: Causes of death in elderly prostate cancer patients and in a comparison nonprostate cancer cohort. J Natl Cancer Inst 2000,92(8):613-621. 10.1093/jnci/92.8.613
10. Mäkinen T, Karhunen P, Aro J, Lahtela J, Määttänen L, Auvinen A: Assessment of causes of death in a prostate cancer screening trial. Int J Cancer 2008,122(2):413-417. 10.1002/ijc.23126
11. Gilbert R, Martin RM, Donovan J, Lane JA, Hamdy F, Neal DE, et al.: Misclassification of outcome in case-control studies: methods for sensitivity analysis. Stat Methods Med Res in press
12. Black WC, Haggstrom DA, Gilbert Welch H: All-cause mortality in randomized trials of cancer screening. J Natl Cancer Inst 2002,94(3):167-173. 10.1093/jnci/94.3.167
13. Hugosson J, Carlsson S, Aus G, Bergdahl S, Khatami A, Lodding P, et al.: Mortality results from the Göteborg randomised population-based prostate-cancer screening trial. Lancet Oncol 2010,11(8):725-732. 10.1016/S1470-2045(10)70146-7
14. Robinson MH, Rodrigues VC, Hardcastle JD, Chamberlain JO, Mangham CM, Moss SM: Faecal occult blood screening for colorectal cancer at Nottingham: details of the verification process. J Med Screen 2000,7(2):97-98. 10.1136/jms.7.2.97
15. Marcus PM, Gareen IF, Miller AB, Rosenbaum J, Keating K, Aberle DR, et al.: The national lung screening Trial's endpoint verification process: determining the cause of death. Contemp Clin Trials 2011,32(6):834-840. 10.1016/j.cct.2011.07.003
16. Gøtzsche PC, Nielsen M: Screening for breast cancer with mammography. Cochrane Database Syst Rev 2009, 4:1.
17. Turner E, Metcalfe C, Donovan J, Noble S, Sterne J, Lane J, et al.: Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). Br J Cancer 2014,110(12):2829-2836. 10.1038/bjc.2014.242
18. Prostate Cancer Risk Management Programme http://www.cancerscreening.nhs.uk/prostate/informationpack.html
19. Lane J, Hamdy F, Martin R, Turner E, Neal D, Donovan J: Latest results from the UK trials evaluating prostate cancer screening and treatment: the CAP and ProtecT studies. Eur J Cancer 2010,46(17):3095-3101. 10.1016/j.ejca.2010.09.016
20. Boutron I, Estellat C, Ravaud P: A review of blinding in randomized controlled trials found results inconsistent and questionable. J Clin Epidemiol 2005,58(12):1220-1226. 10.1016/j.jclinepi.2005.04.006
21. Hróbjartsson A, Forfang E, Haahr M, Als-Nielsen B, Brorson S: Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol 2007,36(3):654-663. 10.1093/ije/dym020
22. Doria-Rose VP, Marcus PM, Miller AB, Bergstralh EJ, Mandel JS, Tockman MS, et al.: Does the source of death information affect cancer screening efficacy results? A study of the use of mortality review versus death certificates in four randomized trials. Clin Trials 2010,7(1):69-77. 10.1177/1740774509356461
23. Barry MJ, Andriole GL, Culkin DJ, Fox SH, Jones KM, Carlyle MH, et al.: Ascertaining cause of death among men in the prostate cancer intervention versus observation trial. Clin Trials 2013,10(6):907-914. 10.1177/1740774513498008
24. Schulz KF, Altman DG, Moher D, Fergusson D: CONSORT 2010 changes and testing blindness in RCTs. Lancet 2010,375(9721):1144-1146. 10.1016/S0140-6736(10)60413-8
25. Frankel S, Smith GD, Donovan J, Neal D: Screening for prostate cancer. Lancet 2003,361(9363):1122-1128. 10.1016/S0140-6736(03)12890-5
26. The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2288/15/6/prepub