Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar
Abstract Background There 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 (UKCTO...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-020-04968-x |
| _version_ | 1818934655304335360 |
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| author | Jatinderpal K. Kalsi Andy Ryan Aleksandra Gentry-Maharaj Danielle Margolin-Crump Naveena Singh Matthew Burnell Elizabeth Benjamin Sophia Apostolidou Mariam Habib Susan Massingham Chloe Karpinskyj Robert Woolas Martin Widschwendter Lesley Fallowfield Stuart Campbell Steven Skates Alistair McGuire Max Parmar Ian Jacobs Usha Menon |
| author_facet | Jatinderpal K. Kalsi Andy Ryan Aleksandra Gentry-Maharaj Danielle Margolin-Crump Naveena Singh Matthew Burnell Elizabeth Benjamin Sophia Apostolidou Mariam Habib Susan Massingham Chloe Karpinskyj Robert Woolas Martin Widschwendter Lesley Fallowfield Stuart Campbell Steven Skates Alistair McGuire Max Parmar Ian Jacobs Usha Menon |
| author_sort | Jatinderpal K. Kalsi |
| collection | DOAJ |
| description | Abstract Background There 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). Methods Of 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). Results Outcome 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. Conclusion Follow-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 registration ISRCTN: ISRCTN22488978 . Registered on 6 April 2000 |
| first_indexed | 2024-12-20T05:07:43Z |
| format | Article |
| id | doaj.art-3f570abb918f4e1a99942bb13aaec63a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T05:07:43Z |
| publishDate | 2021-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3f570abb918f4e1a99942bb13aaec63a2022-12-21T19:52:19ZengBMCTrials1745-62152021-01-0122111110.1186/s13063-020-04968-xCompleteness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplarJatinderpal K. Kalsi0Andy Ryan1Aleksandra Gentry-Maharaj2Danielle Margolin-Crump3Naveena Singh4Matthew Burnell5Elizabeth Benjamin6Sophia Apostolidou7Mariam Habib8Susan Massingham9Chloe Karpinskyj10Robert Woolas11Martin Widschwendter12Lesley Fallowfield13Stuart Campbell14Steven Skates15Alistair McGuire16Max Parmar17Ian Jacobs18Usha Menon19Department of Women’s Cancer, Institute for Women’s Health, University College LondonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonDepartment of Women’s Cancer, Institute for Women’s Health, University College LondonDepartment of Cellular Pathology, Barts Health NHS TrustMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonHCA International, Pathology LaboratoriesMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonDepartment of Women’s Cancer, Institute for Women’s Health, University College LondonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonDepartment of Gynaecological Oncology, Queen Alexandra HospitalDepartment of Women’s Cancer, Institute for Women’s Health, University College LondonSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of SussexCreate HealthMassachusetts General Hospital and Harvard Medical SchoolLondon School of EconomicsMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonDepartment of Women’s Cancer, Institute for Women’s Health, University College LondonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College LondonAbstract Background There 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). Methods Of 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). Results Outcome 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. Conclusion Follow-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 registration ISRCTN: ISRCTN22488978 . Registered on 6 April 2000https://doi.org/10.1186/s13063-020-04968-xOutcomes reviewAdjudicationRandomised controlled trialOvarian cancerScreeningUKCTOCS |
| spellingShingle | Jatinderpal K. Kalsi Andy Ryan Aleksandra Gentry-Maharaj Danielle Margolin-Crump Naveena Singh Matthew Burnell Elizabeth Benjamin Sophia Apostolidou Mariam Habib Susan Massingham Chloe Karpinskyj Robert Woolas Martin Widschwendter Lesley Fallowfield Stuart Campbell Steven Skates Alistair McGuire Max Parmar Ian Jacobs Usha Menon Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar Trials Outcomes review Adjudication Randomised controlled trial Ovarian cancer Screening UKCTOCS |
| title | Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar |
| title_full | Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar |
| title_fullStr | Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar |
| title_full_unstemmed | Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar |
| title_short | Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar |
| title_sort | completeness and accuracy of national cancer and death registration for outcome ascertainment in trials an ovarian cancer exemplar |
| topic | Outcomes review Adjudication Randomised controlled trial Ovarian cancer Screening UKCTOCS |
| url | https://doi.org/10.1186/s13063-020-04968-x |
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