Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

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Refining Ovarian Cancer Test accuracy Scores (ROCkeTS) : protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer. / Sundar, Sudha; Rick, Caroline; Dowling, Francis; Au, Pui; Snell, Kym; Rai, Nirmala; Champaneria, Rita; Stobart, Hilary; Neal, Richard; Davenport, Clare; Mallett, Susan; Sutton, Andrew; Kehoe, Sean; Timmerman, Dirk; Bourne, Tom; Van Calster, Ben; Gentry-Maharaj, Aleksandra; Menon, Usha; Deeks, Jon; ROCkeTS study group.

In: BMJ open, Vol. 6, No. 8, e010333, 09.08.2016.

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Sundar, Sudha ; Rick, Caroline ; Dowling, Francis ; Au, Pui ; Snell, Kym ; Rai, Nirmala ; Champaneria, Rita ; Stobart, Hilary ; Neal, Richard ; Davenport, Clare ; Mallett, Susan ; Sutton, Andrew ; Kehoe, Sean ; Timmerman, Dirk ; Bourne, Tom ; Van Calster, Ben ; Gentry-Maharaj, Aleksandra ; Menon, Usha ; Deeks, Jon ; ROCkeTS study group. / Refining Ovarian Cancer Test accuracy Scores (ROCkeTS) : protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer. In: BMJ open. 2016 ; Vol. 6, No. 8.

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@article{8b0e61b806144fdaa20e0844d93cf323,
title = "Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer",
abstract = "INTRODUCTION: Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III).METHODS AND ANALYSIS: ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios.",
author = "Sudha Sundar and Caroline Rick and Francis Dowling and Pui Au and Kym Snell and Nirmala Rai and Rita Champaneria and Hilary Stobart and Richard Neal and Clare Davenport and Susan Mallett and Andrew Sutton and Sean Kehoe and Dirk Timmerman and Tom Bourne and {Van Calster}, Ben and Aleksandra Gentry-Maharaj and Usha Menon and Jon Deeks and {ROCkeTS study group}",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",
year = "2016",
month = "8",
day = "9",
doi = "10.1136/bmjopen-2015-010333",
language = "English",
volume = "6",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "8",

}

RIS

TY - JOUR

T1 - Refining Ovarian Cancer Test accuracy Scores (ROCkeTS)

T2 - protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

AU - Sundar, Sudha

AU - Rick, Caroline

AU - Dowling, Francis

AU - Au, Pui

AU - Snell, Kym

AU - Rai, Nirmala

AU - Champaneria, Rita

AU - Stobart, Hilary

AU - Neal, Richard

AU - Davenport, Clare

AU - Mallett, Susan

AU - Sutton, Andrew

AU - Kehoe, Sean

AU - Timmerman, Dirk

AU - Bourne, Tom

AU - Van Calster, Ben

AU - Gentry-Maharaj, Aleksandra

AU - Menon, Usha

AU - Deeks, Jon

AU - ROCkeTS study group

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/8/9

Y1 - 2016/8/9

N2 - INTRODUCTION: Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III).METHODS AND ANALYSIS: ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios.

AB - INTRODUCTION: Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III).METHODS AND ANALYSIS: ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios.

U2 - 10.1136/bmjopen-2015-010333

DO - 10.1136/bmjopen-2015-010333

M3 - Article

C2 - 27507231

VL - 6

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 8

M1 - e010333

ER -