Evidence map›Paper›PMID 33494753›Full record

Trial reportTrials2021

Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials-an ovarian cancer exemplar.

Jatinderpal K Kalsi, Andy Ryan, Aleksandra Gentry-Maharaj, Danielle Margolin-Crump, Naveena Singh, Matthew Burnell, Elizabeth Benjamin, Sophia Apostolidou, Mariam Habib, Susan Massingham and 10 more

Open access · goldAbstract readRandomized Controlled Trial

PubMed Full text at PMC Publisher

In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it

0cells of the map it votes in

10citing papers in PubMed

1.5field-weighted citation impact, top 19% of its field

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

Ovarian cancer symptoms in pre-clinical invasive epithelial ovarian cancer - An exploratory analysis nested within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).Gynecologic oncology · 2023
Trial
Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial.Lancet (London, England) · 2021
Trial
Blood Cancer Clinical Trials Long-term Follow-up Using Integrated Healthcare Systems Data (BLISS): protocol for a data-linkage study integrating randomised clinical trials with national healthcare systems data.BMJ open · 2026
Article
Automated data collection in cancer care: State of play among registries in the United Kingdom and Europe.Health information management : journal of the Health Information Management Association of Australia · 2026
Article
Adjudication of cause of death in older adults: Learnings for death certification from the ASPirin in Reducing Events in the Elderly study.Clinical trials (London, England) · 2025
Article
Demographic trends in mortality due to ovarian cancer in the United States, 1999-2020.World journal of clinical oncology · 2025
Article
Linkage of Clinical Trial Data to Routinely Collected Data Sources: A Scoping Review.JAMA network open · 2025
Article
Exploration of Preliminary Objective Triage by Menopause Score and CA 125 Result Prior to Accelerating Fast-Track Booking for Suspected Ovarian Cancer-A Role for the Pathway Navigator?Diagnostics (Basel, Switzerland) · 2024
Article
Trials Methodology Research: what is it and why should India invest in it?The Lancet regional health. Southeast Asia · 2024
Review
Healthcare systems data in the context of clinical trials - A comparison of cardiovascular data from a clinical trial dataset with routinely collected data.Contemporary clinical trials · 2023
Article

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 9 institutions in 3 countries.

Jatinderpal K KalsiDepartment of Women's Cancer, Institute for Women's Health, University College London, London, WC1E 6AU, UK.

Andy RyanMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Aleksandra Gentry-MaharajMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Danielle Margolin-CrumpDepartment of Women's Cancer, Institute for Women's Health, University College London, London, WC1E 6AU, UK.

Naveena SinghDepartment of Cellular Pathology, Barts Health NHS Trust, London, E1 2ES, UK.

Matthew BurnellMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Elizabeth BenjaminHCA International, Pathology Laboratories, London, WC1E 6JA, UK.

Sophia ApostolidouMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Mariam HabibDepartment of Women's Cancer, Institute for Women's Health, University College London, London, WC1E 6AU, UK.

Susan MassinghamMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Chloe KarpinskyjMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Robert WoolasDepartment of Gynaecological Oncology, Queen Alexandra Hospital, Portsmouth, PO6 3LY, UK.

Martin WidschwendterDepartment of Women's Cancer, Institute for Women's Health, University College London, London, WC1E 6AU, UK.

Lesley FallowfieldSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, BN1 9RX, UK.

Stuart CampbellCreate Health, London, EC2V 6ET, UK.

Steven SkatesMassachusetts General Hospital and Harvard Medical School, Boston, MA, 02115, USA.

Alistair McGuireLondon School of Economics, London, WC2A 2AE, UK.

Max ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

Ian JacobsDepartment of Women's Cancer, Institute for Women's Health, University College London, London, WC1E 6AU, UK.

Usha MenonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK. u.menon@ucl.ac.uk.ORCID http://orcid.org/0000-0003-3708-1732

MRC Clinical Trials Unit at UCL · GBLondon Women's Clinic · GBBarts Health NHS Trust · GBBrighton and Sussex Medical School · GBCREATe Centre · GBHarvard University · USLondon School of Economics and Political Science · GBQueen Alexandra Hospital · GBUNSW Sydney · AU

Funding

Department of Health 16/46/01Medical Research Council G0000735Medical Research Council G0801228Medical Research Council G9901012Medical Research Council MC_UU_12023/24Medical Research Council MC_UU_12023/28Medical Research Council MR_UU_12023

6 · The paper itself

Abstract

backgroundThere is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on the completeness and accuracy of national ovarian cancer and death registration in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

methodsOf the 202,638 participants, 202,632 were successfully linked and followed through national cancer and death registries of Northern Ireland, Wales and England. Women with registrations of any of 19 pre-defined ICD-10 codes suggestive of tubo-ovarian cancer or notification of ovarian/tubal/peritoneal cancer from hospital episode statistics or trial sites were identified. Copies of hospital and primary care notes were retrieved and reviewed by an independent outcomes review committee. National registration of site and cause of death as ovarian/tubal/peritoneal cancer (C56/C57/C48) obtained up to 3 months after trial censorship was compared to that assigned by outcomes review (reference standard).

resultsOutcome review was undertaken in 3110 women on whom notification was received between 2001 and 2014. Ovarian cancer was confirmed in 1324 of whom 1125 had a relevant cancer registration. Sensitivity and specificity of ovarian/tubal/peritoneal cancer registration were 85.0% (1125/1324; 95% CI 83.7-86.2%) and 94.0% (1679/1786; 95% CI 93.2-94.8%), respectively. Of 2041 death registrations reviewed, 681 were confirmed to have a tubo-ovarian cancer of whom 605 had relevant death registration. Sensitivity and specificity were 88.8% (605/681; 95% CI 86.4-91.2%) and 96.7% (1482/1533, 95% CI 95.8-97.6%), respectively. When multiple electronic health record sources were considered, sensitivity for cancer site increased to 91.1% (1206/1324, 95% CI 89.4-92.5%) and for cause of death 94.0% (640/681, 95% CI 91.9-95.5%). Of 1232 with cancer registration, 8.7% (107/1232) were wrongly designated as ovarian/tubal/peritoneal cancers by the registry and 4.0% (47/1172) of confirmed tubo-ovarian cancers were mis-registered. In 656 with death registrations, 7.8% (51/656) were wrongly assigned as due to ovarian/tubal/peritoneal cancers while 6.2% (40/645) of confirmed tubo-ovarian cancer deaths were mis-registered.

conclusionFollow-up of trial participants for tubo-ovarian cancer using national registry data will result in incomplete ascertainment, particularly of the site due in part to the latency of registration. This can be reduced by using other routinely collected data such as hospital episode statistics. Central adjudication by experts though resource intensive adds value by improving the accuracy of diagnoses.

trial registrationISRCTN: ISRCTN22488978 . Registered on 6 April 2000.

Indexed as

AgedEarly Detection of CancerFemaleHumansMass ScreeningMiddle AgedOvarian NeoplasmsRegistriesSensitivity and SpecificityUnited KingdomAdjudicationOutcomes reviewOvarian cancerRandomised controlled trialRegistryScreeningUKCTOCS

Identifiers

PMID33494753

DOI10.1186/s13063-020-04968-x

PMCPMC7831170

OpenAlexW3114191899

What OpenQuestion holds

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LicenceCC BY

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.