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Death review process in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial
ELSEVIER
Death Review Process in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Anthony B. Miller, MB, Susan Yurgalevitch,
MS, MPH,
and Joel L. Weissfeld, MD, MPH for the PLCO Project Team Division of Clinical Epidemiology, Deutsches Krebsforschungszentrum, Heidelberg, Germany (A.B.M.); Westat, Inc., Rockville, Maryland (S.Y.); and University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania (J.L. W.)
ABSTRACT: The procedures that have been adopted in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial are described. These procedures have been designed to ensure unbiased decisions on the underlying cause of death for all confirmed or suspected PLCO cancers. A death review committee with a nonvoting chair and three experienced reviewers as members has been appointed. After an initial pilot study, the procedures have been instituted and are working well. Control Clin Trials 2000;21:400’3406S 0 Elsevier Science Inc. 2000 KEY WORDS:
Screening trial, death review
INTRODUCTION Screening results in the diagnosis of cancers earlier in their natural history. Following many screening tests, there is an element of overdiagnosis-the diagnosis of cancers in an individual that in the absence of screening would not have presented in that individual’s lifetime. Therefore, during each year that screening is given in a screening trial, there are likely to be more cancers diagnosed in the screening arm than the control arm. This would not be of concern if the presence of cancer had no influence on death certification practices of physicians. However, it has been recognized for some time that the mere fact that an individual has been diagnosed with cancer has an impact on the cause of death entered on the death certificate, an influence often referred to as the “sticking diagnosis” or more recently as an attribution bias [l]. This Anthony B. Miller is Death Review Committee Chairman. Address reprint requests to: Dorothy Sullivan, Early Detection Research Group, Division of Cancer Prevention, National Cancer Institute, EPN 330, 6130 Executive Blvd., Bethesda, MD 20892.7346; (E-mail: ds255j@nihgov). Received March 27, 2000; accepted May 31, 2000. Controlled Clinical Trials 21:4OOS406S (2000) 0 Elsevier Science Inc. 2000 655 Avenue of the Americas, New York, NY 10010
0197-2456/00/$-see front matter PII SO197-2456(00)00095-7
PLCO Death Review Process
401s
influence can be exhibited in many ways. If a physician is uncertain of the cause of death, but enters cancer at some position on the death certificate, coding rules may tend to select the cancer as the underlying cause of death. If an individual with a prior cancer diagnosis develops distant metastases, there may be an automatic assumption that the known cancer was the origin of the metastasis. However, in an individual with no prior diagnosis of cancer, if metastases develop, there will generally be some search for the primary tumor. If this search had been undertaken in the individual with the screendetected cancer, then another site might have been found to have been the cause of the metastasis, given the frequency of multiple primary tumors, especially in older individuals. Although such an effect could be said to be “conservative” because it will bias the results in the direction of the null hypothesis, it is important to design procedures in a screening trial that will reduce such effects to the minimum. In a screening trial, these ascertainment biases may be magnified if exclusionary criteria are required with regard to the specific cancer(s) of interest when recording the underlying cause of death. More will be known about the cancers in the screening arm of the trial. In spite of many attempts to avoid bias in follow-up procedures, it is inevitable that the screen-detected cancers will be better documented than the non-screen-detected cancers. Thus, if a trial follows a rule such as “in the presence of a cancer, death is regarded as due to that cancer unless it can be proved that death was due to another cause,” as was recently proposed for a screening trial, there will be a bias against the screening arm of the trial. The purpose of this paper is to describe the procedures that have been introduced to minimize bias in assigning cause of death in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, after an initial pilot study that confirmed that the procedures were appropriate and worked well. These procedures are similar to those that were used in the Minnesota Colon Cancer Screening Trial [2], funded by the National Cancer Institute. PRINCIPLES
OF THE DEATH
Several principals l
REVIEW
IN THE PLCO TRIAL
are used in the PLCO death review process:
The procedures for ascertainment of fact of death for participants trial must be unbiased as to allocation.
in the
Once the fact of death has been ascertained, the data collected for death review should be identical, whether the individual had a screen-detected cancer or not. It is recognized, as indicated above, that the documentation for screen-detected cancers will be more extensive and will be collected in a more timely fashion than for cancers in the control group. This bias in cancer ascertainment is inevitable and cannot be overcome. However, this should not preclude attempts to collect identical data from both arms for the purposes of the death review. In particular, diagnostic data available for screen-detected cancers but not available for non-screen-detected cancers are not included in the review “package” submitted to the members of the independent death review committee (DRC). l
402s
A.B. Miller et al.
l
Reviewers are blind as to the allocation in the trial, and all information that could identify whether a cancer was screen-detected is withheld from them.
Application of this principle means that clinical records are edited to remove mention of cancer screening test results and initial clinical presentation (both screen-detected and symptomatic). Medical records for participants in the screened group are more likely to contain direct or indirect mention of the PLCO than the control group. Therefore, clinical records submitted to the DRC are also edited to remove mention of the PLCO, participation in research, or involvement in special cancer detection programs. l
Review of all deaths would be prohibitively costly, but review of only deaths with some indication from the screening center investigations that a PLCO cancer was the cause or a contributing cause of death would not eliminate bias and could give rise to criticism of the trial’s findings.
There is not good evidence that an extensive system of death review justifies the great expense of such an endeavor. Some breast screening trials in Europe have been conducted with no death review at all [3]. The review of records for the Swedish overview analysis of their breast cancer screening trials seems to have had little impact on the findings [4]. The death review in the Canadian National Breast Screening Study appears not to have overcome the problem of the sticking diagnosis, which may be responsible for a nonsignificant excess of breast cancer deaths in the mammography-containing arm in women ages 4049 at entry [5]. This problem may not be avoidable in the PLCO trial given the lack of surveillance (by design) of the control group. Therefore, there are reasons to be somewhat parsimonious as to which categories of death will be reviewed. l
l
l
Decisions on the underlying cause of death are made by three experienced reviewers, who are members of the DRC and are independent of the screening and coordinating centers of the trial, not currently serving on any other PLCO committee.. As a preliminary to determination of the underlying cause of death, the chair of the DRC evaluates the adequacy of the information collected for review. The screening centers attempt collection of any additional information requested by the chair, or subsequently if requested by a DRC member. The reviewers are asked to determine whether the underlying cause of death is “due to,” “probably due to,” “probably not due to,” or “not due to” a PLCO cancer. “Due to” in this context is taken to mean that the disease process and/or associated treatments initiated and/or sustained a chain of events causally responsible for death. The DRC also indicates whether or not other competing disease processes contributed to death. Since not all who died with cancer died of the cancer, an important function of the committee is to decide when there was another underlying cause of death.
PLCO Death Review Process
DEATHS
TO BE REVIEWED
403s BY THE DEATH REVIEW
The DRC reviews any death satisfying the appendix. In summary these comprise:
COMMITTEE
any one of the conditions
set out in
1. a death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that specifies cancer of the prostate, lung, colonrectum, or ovary; 2. a death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that suggests a primary liver, bone, brain, or spinal cord cancer; 3. a death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that suggests uncertainty of the diagnosis of cancer such that cancer of the prostate, lung, colon-rectum, or ovary cannot be excluded or a metastatic cancer with unknown primary; 4. a death certificate coded to an unknown underlying cause of death; 5. death from any cause if the result of a diagnostic-evaluation field on a diagnostic-evaluation form indicates cancer of the prostate, lung, colonrectum, or ovary; 6. death from any cause if any annual study update (ASU) form reports cancer of the prostate, lung, colon-rectum, or ovary, unless subsequent documentation shows that the original report was incorrect; 7. death from any cause if any ASU form suggests an interval diagnosis of a primary malignancy possibly representing misclassified or metastatic cancer of the prostate, lung, colon-rectum, or ovary. PROCEDURE
FOR DEATH REVIEW
Ascertainment of fact of death is the responsibility of the screening centers (SCs). The principal mechanism is through the ASU, which is completed by participants on both the intervention and the control arms of the trial. For those participants reported deceased, the SC contacts the known next of kin or other contact individual to determine further details and, if at all possible, the name and address of the physician who completed the death certificate. A copy of the death certificate is obtained from the relevant vital statistics office or next of kin. For participants who are lost to follow-up, determination of death is accomplished through the State Vital Statistics Office or Cancer Registry and the National Death Index on an annual basis until the vital status of the participant is determined. The coordinating center (CC) applies an algorithm presented in the appendix to determine which deaths are to be reviewed and which are accepted as certified without review after the causes of death have been coded by experienced nosologists at the CC. Lists are supplied to the SCs, which then obtain copies of inpatient and outpatient medical records describing terminal events. Relevant information includes outpatient notes, chemotherapy or radiotherapy summaries, hospital discharge abstracts, hospital admission history and physical, hospital discharge summary, operative and diagnostic procedure reports, pathology reports, autopsy reports, and diagnostic imaging results.
A.B. Miller et al.
404s
The clinical record may contain conflicting or ambiguous information regarding the cancer diagnosis. If deemed important to the determination of a specific cause of death, a DRC member may request acquisition and external review of pathologic slides by a panel of PLCO pathologists. The initial editing of records is undertaken by the SC, which deletes personal identifying information (unless already performed by the contributing institution), as well as the relevant portion of any record that identifies the cancer as screen-detected or makes mention of the PLCO trial. The extracted records are checked by the DRC chair before submission to the members of the DRC. The CC is responsible for managing the death review process.
PROCESS
FOR THE DEATH
REVIEW
All documents are reviewed by three experienced reviewers (the voting members of the DRC) in batches of approximately 30. Reviewers complete a special form for each record, and the forms are returned to the CC. If there is disagreement between “due to,” “probably due to,” “probably not due to,” or “not due to” a PLCO cancer, the DRC members are notified that the case will be reviewed at the next scheduled conference call. At this call, the chair of the DRC moderates and completes a cause-of-death questionnaire.
ACTIONS
FOLLOWING
DEATH
COMMITTEE
REVIEW
If reviewers are unanimous that death was “due to,” “probably due to,” “probably not due to,” or “not due to” a PLCO cancer and are unanimous as to the site of the PLCO cancer, their decision will be recorded for analysis by the CC without any further action. If there is any disagreement, the extent of action will depend on the nature of the disagreement. A telephone conference is held to resolve disagreements. If full agreement cannot be obtained, but two reviewers agree on categorization, this will be recorded for analysis by the CC. The CC reports the panel review decision to the SC. If there is any concern over the review panel decision, that concern can be communicated to the CC, but the review panel decision will remain binding unless the SC collects additional data that can justify re-review by the panel.
REFERENCES 1. Feuer EJ, Merrill RM, Hankey BF. Cancer surveillance series: Interpreting trends in prostate cancer-part II: Cause of death misclassification and the recent rise and fall in prostate cancer mortality. J Nutl Cancer Inst 1999;91:1025-1032. 2. Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Erzg I Med 1993;328:1365-1371. 3. UK Trial of Early Detection of Breast Cancer Group. First results on mortality reduction in the UK Trial of Early Detection of Breast Cancer. Lancet 1988;2:411-416. 4. Nystrom L, Rutqvist LE, Wall S, et al. Breast cancer screening with mammography: Overview of Swedish randomised trials. Lancet 1993;341:973-978.
PLCO Death Review Process
405s
5. Miller AB, Baines CJ, To T, et al. Canadian National Breast Screening Study: 1. Breast cancer detection and death rates among women aged 40 to 49 years. Can Med Assoc ]1992;147:1459-1476.
APPENDIX The Death Review Committee will review deaths due to the following causes: 1. A death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that specifies cancer of the prostate, lung, colon-rectum, or ovary, corresponding to ICD-9 codes: 153-154 (malignant neoplasm of colon or rectum) (malignant neoplasm of trachea, bronchus, and lung) 162 (malignant neoplasm of ovary and other uterine adnexa) 183 (malignant neoplasm of prostate) 185 2. A death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that suggests a primary liver, bone, brain, or spinal cord cancer, corresponding to ICD-9 codes: 155 170 191 192
(malignant neoplasm of liver and intrahepatic bile ducts) (malignant neoplasm of bone and articular cartilage) (malignant neoplasm of brain) (malignant neoplasm of other and unspecified parts of nervous system)
3. A death certificate diagnoses (from an immediate, underlying, or contributing cause-of-death field) that suggests uncertainty of the diagnosis of cancer, such that cancer of the prostate, lung, colon-rectum, or ovary cannot be excluded, or a metastatic cancer with unknown primary, corresponding to ICD-9 codes: 158 159.9 163 165.9 184.9 187.9 195.1,2,3 196-199 239
(malignant neoplasm of retroperitoneum and peritoneum) (malignant neoplasm of ill-defined sites within the digestive organs and peritoneum) (malignant neoplasm of pleura) (malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs) (malignant neoplasm of unspecified female genital organ) (malignant neoplasm of male genital organ, site unspecified) (malignant neoplasm of other ill-defined sites [thorax, abdomen, or pelvis]) (without ICD-9 140-195) (neoplasm of unspecified nature)
4. A death certificate coded to an unknown corresponding to ICD-9 codes: 789 797 799
underlying
cause of death,
(sudden death, cause unknown) (senility without mention of psychosis) (other ill-defined and unknown causes)
5. Death from any cause if the result of a diagnostic-evaluation-field
on a
A.B. Miller et al.
406s
diagnostic evaluation form indicates cancer of the prostate, lung, colonrectum, or ovary, corresponding to ICD-9 codes: 153-154 162 183 185
(malignant neoplasm (malignant neoplasm (malignant neoplasm (malignant neoplasm
of of of of
colon or rectum) trachea, bronchus, and lung) ovary and other uterine adnexa) prostate)
6. Death from any cause if any ASU form reports cancer of the prostate, lung, colon-rectum, or ovary, unless subsequent documentation shows that the original report was incorrect. 7. Death from any cause if any ASU form suggests an interval diagnosis of a primary malignancy possibly representing misclassified or metastatic cancer of the prostate, lung, colon-rectum, or ovary. Entry of any one of the following ICD-9 codes will trigger death review: 155 158 159.9 163 165.9 170 184.9 187.9 191 192 195.1,2,3 196-199 239
(malignant neoplasm of liver and intrahepatic bile ducts) (malignant neoplasm of retroperitoneum and peritoneum) (malignant neoplasm of ill-defined sites within the digestive organs and peritoneum) (malignant neoplasm of pleura) (malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs) (malignant neoplasm of bone and articular cartilage) (malignant neoplasm of unspecified female genital organ) (malignant neoplasm of male genital organ, site unspecified) (malignant neoplasm of brain) (malignant neoplasm of other and unspecified parts of nervous system) (malignant neoplasm of other ill-defined sites [thorax, abdomen, or pelvis]) (without ICD-9 140-195) (neoplasm of unspecified nature)
Death Review Process in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Anthony B. Miller, MB, Susan Yurgalevitch,
MS, MPH,
and Joel L. Weissfeld, MD, MPH for the PLCO Project Team Division of Clinical Epidemiology, Deutsches Krebsforschungszentrum, Heidelberg, Germany (A.B.M.); Westat, Inc., Rockville, Maryland (S.Y.); and University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania (J.L. W.)
ABSTRACT: The procedures that have been adopted in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial are described. These procedures have been designed to ensure unbiased decisions on the underlying cause of death for all confirmed or suspected PLCO cancers. A death review committee with a nonvoting chair and three experienced reviewers as members has been appointed. After an initial pilot study, the procedures have been instituted and are working well. Control Clin Trials 2000;21:400’3406S 0 Elsevier Science Inc. 2000 KEY WORDS:
Screening trial, death review
INTRODUCTION Screening results in the diagnosis of cancers earlier in their natural history. Following many screening tests, there is an element of overdiagnosis-the diagnosis of cancers in an individual that in the absence of screening would not have presented in that individual’s lifetime. Therefore, during each year that screening is given in a screening trial, there are likely to be more cancers diagnosed in the screening arm than the control arm. This would not be of concern if the presence of cancer had no influence on death certification practices of physicians. However, it has been recognized for some time that the mere fact that an individual has been diagnosed with cancer has an impact on the cause of death entered on the death certificate, an influence often referred to as the “sticking diagnosis” or more recently as an attribution bias [l]. This Anthony B. Miller is Death Review Committee Chairman. Address reprint requests to: Dorothy Sullivan, Early Detection Research Group, Division of Cancer Prevention, National Cancer Institute, EPN 330, 6130 Executive Blvd., Bethesda, MD 20892.7346; (E-mail: ds255j@nihgov). Received March 27, 2000; accepted May 31, 2000. Controlled Clinical Trials 21:4OOS406S (2000) 0 Elsevier Science Inc. 2000 655 Avenue of the Americas, New York, NY 10010
0197-2456/00/$-see front matter PII SO197-2456(00)00095-7
PLCO Death Review Process
401s
influence can be exhibited in many ways. If a physician is uncertain of the cause of death, but enters cancer at some position on the death certificate, coding rules may tend to select the cancer as the underlying cause of death. If an individual with a prior cancer diagnosis develops distant metastases, there may be an automatic assumption that the known cancer was the origin of the metastasis. However, in an individual with no prior diagnosis of cancer, if metastases develop, there will generally be some search for the primary tumor. If this search had been undertaken in the individual with the screendetected cancer, then another site might have been found to have been the cause of the metastasis, given the frequency of multiple primary tumors, especially in older individuals. Although such an effect could be said to be “conservative” because it will bias the results in the direction of the null hypothesis, it is important to design procedures in a screening trial that will reduce such effects to the minimum. In a screening trial, these ascertainment biases may be magnified if exclusionary criteria are required with regard to the specific cancer(s) of interest when recording the underlying cause of death. More will be known about the cancers in the screening arm of the trial. In spite of many attempts to avoid bias in follow-up procedures, it is inevitable that the screen-detected cancers will be better documented than the non-screen-detected cancers. Thus, if a trial follows a rule such as “in the presence of a cancer, death is regarded as due to that cancer unless it can be proved that death was due to another cause,” as was recently proposed for a screening trial, there will be a bias against the screening arm of the trial. The purpose of this paper is to describe the procedures that have been introduced to minimize bias in assigning cause of death in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, after an initial pilot study that confirmed that the procedures were appropriate and worked well. These procedures are similar to those that were used in the Minnesota Colon Cancer Screening Trial [2], funded by the National Cancer Institute. PRINCIPLES
OF THE DEATH
Several principals l
REVIEW
IN THE PLCO TRIAL
are used in the PLCO death review process:
The procedures for ascertainment of fact of death for participants trial must be unbiased as to allocation.
in the
Once the fact of death has been ascertained, the data collected for death review should be identical, whether the individual had a screen-detected cancer or not. It is recognized, as indicated above, that the documentation for screen-detected cancers will be more extensive and will be collected in a more timely fashion than for cancers in the control group. This bias in cancer ascertainment is inevitable and cannot be overcome. However, this should not preclude attempts to collect identical data from both arms for the purposes of the death review. In particular, diagnostic data available for screen-detected cancers but not available for non-screen-detected cancers are not included in the review “package” submitted to the members of the independent death review committee (DRC). l
402s
A.B. Miller et al.
l
Reviewers are blind as to the allocation in the trial, and all information that could identify whether a cancer was screen-detected is withheld from them.
Application of this principle means that clinical records are edited to remove mention of cancer screening test results and initial clinical presentation (both screen-detected and symptomatic). Medical records for participants in the screened group are more likely to contain direct or indirect mention of the PLCO than the control group. Therefore, clinical records submitted to the DRC are also edited to remove mention of the PLCO, participation in research, or involvement in special cancer detection programs. l
Review of all deaths would be prohibitively costly, but review of only deaths with some indication from the screening center investigations that a PLCO cancer was the cause or a contributing cause of death would not eliminate bias and could give rise to criticism of the trial’s findings.
There is not good evidence that an extensive system of death review justifies the great expense of such an endeavor. Some breast screening trials in Europe have been conducted with no death review at all [3]. The review of records for the Swedish overview analysis of their breast cancer screening trials seems to have had little impact on the findings [4]. The death review in the Canadian National Breast Screening Study appears not to have overcome the problem of the sticking diagnosis, which may be responsible for a nonsignificant excess of breast cancer deaths in the mammography-containing arm in women ages 4049 at entry [5]. This problem may not be avoidable in the PLCO trial given the lack of surveillance (by design) of the control group. Therefore, there are reasons to be somewhat parsimonious as to which categories of death will be reviewed. l
l
l
Decisions on the underlying cause of death are made by three experienced reviewers, who are members of the DRC and are independent of the screening and coordinating centers of the trial, not currently serving on any other PLCO committee.. As a preliminary to determination of the underlying cause of death, the chair of the DRC evaluates the adequacy of the information collected for review. The screening centers attempt collection of any additional information requested by the chair, or subsequently if requested by a DRC member. The reviewers are asked to determine whether the underlying cause of death is “due to,” “probably due to,” “probably not due to,” or “not due to” a PLCO cancer. “Due to” in this context is taken to mean that the disease process and/or associated treatments initiated and/or sustained a chain of events causally responsible for death. The DRC also indicates whether or not other competing disease processes contributed to death. Since not all who died with cancer died of the cancer, an important function of the committee is to decide when there was another underlying cause of death.
PLCO Death Review Process
DEATHS
TO BE REVIEWED
403s BY THE DEATH REVIEW
The DRC reviews any death satisfying the appendix. In summary these comprise:
COMMITTEE
any one of the conditions
set out in
1. a death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that specifies cancer of the prostate, lung, colonrectum, or ovary; 2. a death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that suggests a primary liver, bone, brain, or spinal cord cancer; 3. a death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that suggests uncertainty of the diagnosis of cancer such that cancer of the prostate, lung, colon-rectum, or ovary cannot be excluded or a metastatic cancer with unknown primary; 4. a death certificate coded to an unknown underlying cause of death; 5. death from any cause if the result of a diagnostic-evaluation field on a diagnostic-evaluation form indicates cancer of the prostate, lung, colonrectum, or ovary; 6. death from any cause if any annual study update (ASU) form reports cancer of the prostate, lung, colon-rectum, or ovary, unless subsequent documentation shows that the original report was incorrect; 7. death from any cause if any ASU form suggests an interval diagnosis of a primary malignancy possibly representing misclassified or metastatic cancer of the prostate, lung, colon-rectum, or ovary. PROCEDURE
FOR DEATH REVIEW
Ascertainment of fact of death is the responsibility of the screening centers (SCs). The principal mechanism is through the ASU, which is completed by participants on both the intervention and the control arms of the trial. For those participants reported deceased, the SC contacts the known next of kin or other contact individual to determine further details and, if at all possible, the name and address of the physician who completed the death certificate. A copy of the death certificate is obtained from the relevant vital statistics office or next of kin. For participants who are lost to follow-up, determination of death is accomplished through the State Vital Statistics Office or Cancer Registry and the National Death Index on an annual basis until the vital status of the participant is determined. The coordinating center (CC) applies an algorithm presented in the appendix to determine which deaths are to be reviewed and which are accepted as certified without review after the causes of death have been coded by experienced nosologists at the CC. Lists are supplied to the SCs, which then obtain copies of inpatient and outpatient medical records describing terminal events. Relevant information includes outpatient notes, chemotherapy or radiotherapy summaries, hospital discharge abstracts, hospital admission history and physical, hospital discharge summary, operative and diagnostic procedure reports, pathology reports, autopsy reports, and diagnostic imaging results.
A.B. Miller et al.
404s
The clinical record may contain conflicting or ambiguous information regarding the cancer diagnosis. If deemed important to the determination of a specific cause of death, a DRC member may request acquisition and external review of pathologic slides by a panel of PLCO pathologists. The initial editing of records is undertaken by the SC, which deletes personal identifying information (unless already performed by the contributing institution), as well as the relevant portion of any record that identifies the cancer as screen-detected or makes mention of the PLCO trial. The extracted records are checked by the DRC chair before submission to the members of the DRC. The CC is responsible for managing the death review process.
PROCESS
FOR THE DEATH
REVIEW
All documents are reviewed by three experienced reviewers (the voting members of the DRC) in batches of approximately 30. Reviewers complete a special form for each record, and the forms are returned to the CC. If there is disagreement between “due to,” “probably due to,” “probably not due to,” or “not due to” a PLCO cancer, the DRC members are notified that the case will be reviewed at the next scheduled conference call. At this call, the chair of the DRC moderates and completes a cause-of-death questionnaire.
ACTIONS
FOLLOWING
DEATH
COMMITTEE
REVIEW
If reviewers are unanimous that death was “due to,” “probably due to,” “probably not due to,” or “not due to” a PLCO cancer and are unanimous as to the site of the PLCO cancer, their decision will be recorded for analysis by the CC without any further action. If there is any disagreement, the extent of action will depend on the nature of the disagreement. A telephone conference is held to resolve disagreements. If full agreement cannot be obtained, but two reviewers agree on categorization, this will be recorded for analysis by the CC. The CC reports the panel review decision to the SC. If there is any concern over the review panel decision, that concern can be communicated to the CC, but the review panel decision will remain binding unless the SC collects additional data that can justify re-review by the panel.
REFERENCES 1. Feuer EJ, Merrill RM, Hankey BF. Cancer surveillance series: Interpreting trends in prostate cancer-part II: Cause of death misclassification and the recent rise and fall in prostate cancer mortality. J Nutl Cancer Inst 1999;91:1025-1032. 2. Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Erzg I Med 1993;328:1365-1371. 3. UK Trial of Early Detection of Breast Cancer Group. First results on mortality reduction in the UK Trial of Early Detection of Breast Cancer. Lancet 1988;2:411-416. 4. Nystrom L, Rutqvist LE, Wall S, et al. Breast cancer screening with mammography: Overview of Swedish randomised trials. Lancet 1993;341:973-978.
PLCO Death Review Process
405s
5. Miller AB, Baines CJ, To T, et al. Canadian National Breast Screening Study: 1. Breast cancer detection and death rates among women aged 40 to 49 years. Can Med Assoc ]1992;147:1459-1476.
APPENDIX The Death Review Committee will review deaths due to the following causes: 1. A death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that specifies cancer of the prostate, lung, colon-rectum, or ovary, corresponding to ICD-9 codes: 153-154 (malignant neoplasm of colon or rectum) (malignant neoplasm of trachea, bronchus, and lung) 162 (malignant neoplasm of ovary and other uterine adnexa) 183 (malignant neoplasm of prostate) 185 2. A death certificate diagnosis (from an immediate, underlying, or contributing cause-of-death field) that suggests a primary liver, bone, brain, or spinal cord cancer, corresponding to ICD-9 codes: 155 170 191 192
(malignant neoplasm of liver and intrahepatic bile ducts) (malignant neoplasm of bone and articular cartilage) (malignant neoplasm of brain) (malignant neoplasm of other and unspecified parts of nervous system)
3. A death certificate diagnoses (from an immediate, underlying, or contributing cause-of-death field) that suggests uncertainty of the diagnosis of cancer, such that cancer of the prostate, lung, colon-rectum, or ovary cannot be excluded, or a metastatic cancer with unknown primary, corresponding to ICD-9 codes: 158 159.9 163 165.9 184.9 187.9 195.1,2,3 196-199 239
(malignant neoplasm of retroperitoneum and peritoneum) (malignant neoplasm of ill-defined sites within the digestive organs and peritoneum) (malignant neoplasm of pleura) (malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs) (malignant neoplasm of unspecified female genital organ) (malignant neoplasm of male genital organ, site unspecified) (malignant neoplasm of other ill-defined sites [thorax, abdomen, or pelvis]) (without ICD-9 140-195) (neoplasm of unspecified nature)
4. A death certificate coded to an unknown corresponding to ICD-9 codes: 789 797 799
underlying
cause of death,
(sudden death, cause unknown) (senility without mention of psychosis) (other ill-defined and unknown causes)
5. Death from any cause if the result of a diagnostic-evaluation-field
on a
A.B. Miller et al.
406s
diagnostic evaluation form indicates cancer of the prostate, lung, colonrectum, or ovary, corresponding to ICD-9 codes: 153-154 162 183 185
(malignant neoplasm (malignant neoplasm (malignant neoplasm (malignant neoplasm
of of of of
colon or rectum) trachea, bronchus, and lung) ovary and other uterine adnexa) prostate)
6. Death from any cause if any ASU form reports cancer of the prostate, lung, colon-rectum, or ovary, unless subsequent documentation shows that the original report was incorrect. 7. Death from any cause if any ASU form suggests an interval diagnosis of a primary malignancy possibly representing misclassified or metastatic cancer of the prostate, lung, colon-rectum, or ovary. Entry of any one of the following ICD-9 codes will trigger death review: 155 158 159.9 163 165.9 170 184.9 187.9 191 192 195.1,2,3 196-199 239
(malignant neoplasm of liver and intrahepatic bile ducts) (malignant neoplasm of retroperitoneum and peritoneum) (malignant neoplasm of ill-defined sites within the digestive organs and peritoneum) (malignant neoplasm of pleura) (malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs) (malignant neoplasm of bone and articular cartilage) (malignant neoplasm of unspecified female genital organ) (malignant neoplasm of male genital organ, site unspecified) (malignant neoplasm of brain) (malignant neoplasm of other and unspecified parts of nervous system) (malignant neoplasm of other ill-defined sites [thorax, abdomen, or pelvis]) (without ICD-9 140-195) (neoplasm of unspecified nature)