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)

CAP Cause of Death Committee

doi:10.1186/1471-2288-15-6

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)

CAP Cause of Death Committee

Research output: Contribution to journal › Article (Academic Journal) › peer-review

10 Citations (Scopus)

52 Downloads (Pure)

Abstract

Background

In cancer screening trials where the primary outcome is target cancer-specific mortality, the unbiased determination of underlying cause of death (UCD) is crucial. To minimise bias, the UCD should be independently verified by expert reviewers, blinded to death certificate data and trial arm. We investigated whether standardising the information submitted for UCD assignment in a population-based randomised controlled trial of prostate-specific antigen (PSA) testing for prostate cancer reduced the reviewers’ ability to correctly guess the trial arm.

Methods

Over 550 General Practitioner (GP) practices (>415,000 men aged 50–69 years) were cluster-randomised to PSA testing (intervention arm) or the National Health Service (NHS) prostate cancer risk management programme (control arm) between 2001 and 2007. Assignment of UCD was by independent reviews of researcher-written clinical vignettes that masked trial arm and death certificate information. A period of time after the process began (the initial phase), we analysed whether the reviewers could correctly identify trial arm from the vignettes, and the reasons for their choice. This feedback led to further standardisation of information (second phase), after which we re-assessed the extent of correct identification of trial arm.

Results

1099 assessments of 509 vignettes were completed by January 2014. In the initial phase (n = 510 assessments), reviewers were unsure of trial arm in 33% of intervention and 30% of control arm assessments and were influenced by symptoms at diagnosis, PSA test result and study-specific criteria. In the second phase (n = 589), the respective proportions of uncertainty were 45% and 48%. The percentage of cases whereby reviewers were unable to determine the trial arm was greater following the standardisation of information provided in the vignettes. The chances of a correct guess and an incorrect guess were equalised in each arm, following further standardisation.

Conclusions

It is possible to mask trial arm from cause of death reviewers, by using their feedback to standardise the information submitted to them.

Trial registration

ISRCTN92187251

Original language	English
Article number	6
Number of pages	8
Journal	BMC Medical Research Methodology
Volume	15
Issue number	6
DOIs	https://doi.org/10.1186/1471-2288-15-6
Publication status	Published - 23 Jan 2015

Research Groups and Themes

BTC (Bristol Trials Centre)
Centre for Surgical Research

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/1471-2288-15-6

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ConDuCT-II
Blazeby, J. (Principal Investigator)
1/04/14 → 31/03/19
Project: Research

Cite this

@article{f3e3e685d2714550b4ac569de164548e,

title = "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)",

abstract = "BackgroundIn cancer screening trials where the primary outcome is target cancer-specific mortality, the unbiased determination of underlying cause of death (UCD) is crucial. To minimise bias, the UCD should be independently verified by expert reviewers, blinded to death certificate data and trial arm. We investigated whether standardising the information submitted for UCD assignment in a population-based randomised controlled trial of prostate-specific antigen (PSA) testing for prostate cancer reduced the reviewers{\textquoteright} ability to correctly guess the trial arm.MethodsOver 550 General Practitioner (GP) practices (>415,000 men aged 50–69 years) were cluster-randomised to PSA testing (intervention arm) or the National Health Service (NHS) prostate cancer risk management programme (control arm) between 2001 and 2007. Assignment of UCD was by independent reviews of researcher-written clinical vignettes that masked trial arm and death certificate information. A period of time after the process began (the initial phase), we analysed whether the reviewers could correctly identify trial arm from the vignettes, and the reasons for their choice. This feedback led to further standardisation of information (second phase), after which we re-assessed the extent of correct identification of trial arm.Results1099 assessments of 509 vignettes were completed by January 2014. In the initial phase (n = 510 assessments), reviewers were unsure of trial arm in 33% of intervention and 30% of control arm assessments and were influenced by symptoms at diagnosis, PSA test result and study-specific criteria. In the second phase (n = 589), the respective proportions of uncertainty were 45% and 48%. The percentage of cases whereby reviewers were unable to determine the trial arm was greater following the standardisation of information provided in the vignettes. The chances of a correct guess and an incorrect guess were equalised in each arm, following further standardisation.ConclusionsIt is possible to mask trial arm from cause of death reviewers, by using their feedback to standardise the information submitted to them.Trial registrationISRCTN92187251",

keywords = "Underlying cause of death, Verification, Bias, Prostate cancer, Blinding, Standardisation of information, Trial arm, Endpoint review, Outcome assessors",

author = "{CAP Cause of Death Committee} and Williams, {Naomi J} and Elizabeth Hill and Ng, {Siaw Yein} and Martin, {Richard M} and Chris Metcalfe and Donovan, {Jenny L} and Simon Evans and Hughes, {Laura J} and Davies, {Charlotte F} and Hamdy, {Freddie C} and Neal, {David E} and Turner, {Emma L}",

year = "2015",

month = jan,

day = "23",

doi = "10.1186/1471-2288-15-6",

language = "English",

volume = "15",

journal = "BMC Medical Research Methodology",

issn = "1471-2288",

publisher = "BioMed Central",

number = "6",

}

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). / CAP Cause of Death Committee.
In: BMC Medical Research Methodology, Vol. 15, No. 6, 6, 23.01.2015.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial

T2 - lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer)

AU - CAP Cause of Death Committee

AU - Williams, Naomi J

AU - Hill, Elizabeth

AU - Ng, Siaw Yein

AU - Martin, Richard M

AU - Metcalfe, Chris

AU - Donovan, Jenny L

AU - Evans, Simon

AU - Hughes, Laura J

AU - Davies, Charlotte F

AU - Hamdy, Freddie C

AU - Neal, David E

AU - Turner, Emma L

PY - 2015/1/23

Y1 - 2015/1/23

N2 - BackgroundIn cancer screening trials where the primary outcome is target cancer-specific mortality, the unbiased determination of underlying cause of death (UCD) is crucial. To minimise bias, the UCD should be independently verified by expert reviewers, blinded to death certificate data and trial arm. We investigated whether standardising the information submitted for UCD assignment in a population-based randomised controlled trial of prostate-specific antigen (PSA) testing for prostate cancer reduced the reviewers’ ability to correctly guess the trial arm.MethodsOver 550 General Practitioner (GP) practices (>415,000 men aged 50–69 years) were cluster-randomised to PSA testing (intervention arm) or the National Health Service (NHS) prostate cancer risk management programme (control arm) between 2001 and 2007. Assignment of UCD was by independent reviews of researcher-written clinical vignettes that masked trial arm and death certificate information. A period of time after the process began (the initial phase), we analysed whether the reviewers could correctly identify trial arm from the vignettes, and the reasons for their choice. This feedback led to further standardisation of information (second phase), after which we re-assessed the extent of correct identification of trial arm.Results1099 assessments of 509 vignettes were completed by January 2014. In the initial phase (n = 510 assessments), reviewers were unsure of trial arm in 33% of intervention and 30% of control arm assessments and were influenced by symptoms at diagnosis, PSA test result and study-specific criteria. In the second phase (n = 589), the respective proportions of uncertainty were 45% and 48%. The percentage of cases whereby reviewers were unable to determine the trial arm was greater following the standardisation of information provided in the vignettes. The chances of a correct guess and an incorrect guess were equalised in each arm, following further standardisation.ConclusionsIt is possible to mask trial arm from cause of death reviewers, by using their feedback to standardise the information submitted to them.Trial registrationISRCTN92187251

AB - BackgroundIn cancer screening trials where the primary outcome is target cancer-specific mortality, the unbiased determination of underlying cause of death (UCD) is crucial. To minimise bias, the UCD should be independently verified by expert reviewers, blinded to death certificate data and trial arm. We investigated whether standardising the information submitted for UCD assignment in a population-based randomised controlled trial of prostate-specific antigen (PSA) testing for prostate cancer reduced the reviewers’ ability to correctly guess the trial arm.MethodsOver 550 General Practitioner (GP) practices (>415,000 men aged 50–69 years) were cluster-randomised to PSA testing (intervention arm) or the National Health Service (NHS) prostate cancer risk management programme (control arm) between 2001 and 2007. Assignment of UCD was by independent reviews of researcher-written clinical vignettes that masked trial arm and death certificate information. A period of time after the process began (the initial phase), we analysed whether the reviewers could correctly identify trial arm from the vignettes, and the reasons for their choice. This feedback led to further standardisation of information (second phase), after which we re-assessed the extent of correct identification of trial arm.Results1099 assessments of 509 vignettes were completed by January 2014. In the initial phase (n = 510 assessments), reviewers were unsure of trial arm in 33% of intervention and 30% of control arm assessments and were influenced by symptoms at diagnosis, PSA test result and study-specific criteria. In the second phase (n = 589), the respective proportions of uncertainty were 45% and 48%. The percentage of cases whereby reviewers were unable to determine the trial arm was greater following the standardisation of information provided in the vignettes. The chances of a correct guess and an incorrect guess were equalised in each arm, following further standardisation.ConclusionsIt is possible to mask trial arm from cause of death reviewers, by using their feedback to standardise the information submitted to them.Trial registrationISRCTN92187251

KW - Underlying cause of death

KW - Verification

KW - Bias

KW - Prostate cancer

KW - Blinding

KW - Standardisation of information

KW - Trial arm

KW - Endpoint review

KW - Outcome assessors

U2 - 10.1186/1471-2288-15-6

DO - 10.1186/1471-2288-15-6

M3 - Article (Academic Journal)

C2 - 25613468

SN - 1471-2288

VL - 15

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

IS - 6

M1 - 6

ER -

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)

Abstract

Research Groups and Themes

Keywords

UN SDGs

Access to Document

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Projects

ConDuCT-II

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