期刊论文详细信息
Trials
Changing case Order to Optimise patterns of Performance in mammography Screening (CO-OPS): study protocol for a randomized controlled trial
Aileen Clarke1  Simon Gates1  Ala Szczepura1  Sarah Sellars2  Helen Campbell4  Nigel Stallard1  Janet Dunn1  Helen Parsons1  Matthew G Wallis3  Sian Taylor-Phillips1 
[1] Warwick Medical School, The University of Warwick, Coventry CV4 7AL, UK;NHS Cancer Screening Programmes, Public Health England, Fulwood House, Old Fulwood Road, Sheffield S10 3TH, UK;Cambridge Breast Unit and NIHR Cambridge Biomedical Research Centre, Box 97, Cambridge University Hospitals NHS Foundation Trust, Biomedical Campus, Hills Road, Cambridge CB2 0QQ, UK;Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK
关键词: Vigilance decrement;    Screening;    Observer performance;    Mammography;    Fatigue;    Breast cancer;   
Others  :  807667
DOI  :  10.1186/1745-6215-15-17
 received in 2013-08-27, accepted in 2013-12-09,  发布年份 2014
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【 摘 要 】

Background

X-ray mammography remains the predominant test for screening for breast cancer, with the aim of reducing breast cancer mortality. In the English NHS Breast Screening Programme each woman’s mammograms are examined separately by two expert readers. The two readers read each batch in the same order and each indicates if there should be recall for further tests. This is a highly skilled, pressurised, repetitive and frequently intellectually unchallenging activity where readers examine one or more batches of 30–50 women’s mammograms in each session. A vigilance decrement or performance decrease over time has been observed in similar repetitive visual tasks such as radar operation.

Methods/Design

The CO-OPS study is a pragmatic, multi-centre, two-arm, double blind cluster randomised controlled trial of a computer software intervention designed to reduce the effects of a vigilance decrement in breast cancer screening. The unit of randomisation is the batch. Intervention batches will be examined in the opposite order by the two readers (one forwards, one backwards). Control batches will be read in the same order as one another, as is current standard practice. The hypothesis is that cancer detection rates will be higher in the intervention group because each readers’ peak performance will occur when examining different women’s mammograms. The trial will take place in 44 English breast screening centres for 1 year and 4 months. The primary outcome is cancer detection rate, which will be extracted from computer records after 1 year of the trial. The secondary outcomes include rate of disagreement between readers (a more statistically powerful surrogate for cancer detection rate), recall rate, positive predictive value, and interval cancer rate (cancers found between screening rounds which will be measured three years after the end of the trial).

Discussion

This is the first trial of an intervention to ameliorate a vigilance decrement in breast cancer screening.

Trial registration

ISRCTN46603370 (submitted: 24 October 2012, date of registration: 26 March 2013).

【 授权许可】

   
2014 Taylor-Phillips et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]Office for National Statistics, Mortality Statistics: Deaths Registered in England and Wales (Series DR), 2010. Available at http://www.ons.gov.uk/ons/publications/re-reference-tables.html?edition=tcm%3A77-230730 webcite (accessed 16 December 2013)
  • [2]National Health Service: Cancer Reform Strategy. London: The Department of Health; 2007. Available at (http://www.nhs.uk/NHSEngland/NSF/Documents/Cancer%20Reform%20Strategy.pdf webcite) (accessed 16 December 2013)
  • [3]The NHS Information Centre, Screening and Immunisations: Breast Screening Programme, England—2010–11 [NS]. Leeds, UK: The Health and Social Care Information Centre; 2012. Available at http://www.hscic.gov.uk/searchcatalogue?productid=4899&q=breast+screening&sort=Title&size=10&page=1#top webcite (accessed 16 December 2013)
  • [4]Beral V, Cush S, Ellis IO, Emery J, Faulkner K, Given-Wilson R, Law M, Loughlin J, Michell MJ, Moss SM, Noblet M, Patnick J, Reed M, Rubin C, Toward K, Winstone D, Austoker J, Berrington A, Blanks RG, Day NE, Day TJ, Møller H, Quinn M, Wallis MG, Wilson ARM, Advisory Committee on Breast Cancer Screening: Screening for Breast Cancer in England: Past and Future. Sheffield, UK: NHS Cancer Screening Programmes; 2006. [(NHSBSP Publication No. 61)] Available at http://www.cancerscreening.nhs.uk/breastscreen/publications/nhsbsp61.pdf webcite (accessed 20 December 2013)
  • [5]Moss S, Blanks R, Interval Cancer Working Group: Calculating appropriate target cancer detection rates and expected interval cancer rates for the UK NHS Breast Screening Programme. J Epidemiol Community Health 1998, 52:111-115.
  • [6]Offman J, Duffy SW, National Collation of Breast Interval Cancer Data: Screening Years 1st April 2003–31st March 2005. Sheffield, UK: NHS Cancer Screening Programmes; 2012. [(NHSBSP Occasional Report 12/03)] Available at http://www.cancerscreening.nhs.uk/breastscreen/publications/nhsbsp-occasional-report1203.pdf webcite (accessed 20 December 2013)
  • [7]Taylor-Phillips S, Wallis MG, Gale AG: Should previous mammograms be digitised in the transition to digital mammography? Eur Radiol 2009, 19:1890-1896.
  • [8]See JE, Howe SR, Warm JS, Dember WN: Metaanalysis of the sensitivity decrement in vigilance. Psychol Bull 1995, 117:230-249.
  • [9]Medical Research Council: MRC Guidelines for Good Clinical Practice in Clinical Trials. London: Medical Research Council; 1998. [(MRC Clinical Trials Series)] Available from http://www.mrc.ac.uk/utilities/documentrecord/index.htm?d=mrc002416 webcite (accessed 20 December 2013)
  • [10]Moher D, Schulz KF, Altman DG, for the CONSORT Group: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001, 357:1191-1194.
  • [11]Campbell MK, Piaggio G, Elbourne DR, Altman DG, for the CONSORT Group: CONSORT 2010 statement: extension to cluster randomised trials. BMJ 2012, 345:e5661.
  • [12]Campbell HE, Epstein D, Bloomfield D, Griffin S, Manca A, Yarnold J, Bliss J, Johnson L, Earl H, Poole C, Hiller L, Dunn J, Hopwood P, Barrett-Lee P, Ellis P, Cameron D, Harris AL, Gray AM, Sculpher MJ: The cost-effectiveness of adjuvant chemotherapy for early breast cancer: a comparison of no chemotherapy and first, second, and third generation regimens for patients with differing prognoses. Eur J Cancer 2011, 47:2517-2530.
  • [13]Golstein H, Browne W, Rasbash J: Partitioning variation in multilevel models. Underst Stat 2002, 1:223-231. doi:10.1207/S15328031US0104_02
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