# Measures of Prognosis. Sukon Kanchanaraksa, PhD Johns Hopkins University

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2 Measures of Prognosis Sukon Kanchanaraksa, PhD Johns Hopkins University

3 Quantifying the Prognosis A person who was just diagnosed with a disease would be interested in the prognosis of the disease Prognosis is predicting the progress or outcome of the disease Any measures used to quantify prognosis must then be casebased That is, the denominator is the number of people with the specified disease 3

4 Natural History of Disease Preclinical Clinical Disease onset Diagnosis Prognosis Preclinical Disease onset Diagnosis Clinical Prognosis 4

5 Identifying the Onset of Disease Infectious diseases Exposure (bite, infection, etc.) Biological culture Presence of antibody responses, viral DNA and RNA 5

6 Identifying the Onset of Disease Cancer Initial damage from radiation or chemicals First cancer cell division Lost of cell replication Screening for pathologic changes during preclinical phase First evidence of signs and symptoms Medical diagnosis of disease Preclinical phase Clinical phase Biological onset of disease Pathologic evidence of disease Signs and symptoms of disease Medical care sought Diagnosis Treatment 6

7 Identifying the Endpoints of Disease Death Cure Remission A decrease in, or disappearance of, signs and symptoms of disease Recurrences A return of disease 7

8 Expressing Prognosis Case-fatality (rate) or CFR Five-year survival Observed survival rate Median survival time Relative survival rate 8

9 Expressing Prognosis: Case-Fatality Rate (CFR) Case-fatality (rate) = number of people who die of a disease number of people who have the disease Example 200 people with the disease 20 deaths from the disease CFR = 20 x % 9

10 Expressing Prognosis: Five-Year Survival Five-year survival is the proportion of patients who are alive five years after diagnosis number of persons with the specified disease surviving 5 years totalnumber of persons with the specified disease Preclinical Clinical Disease onset Diagnosis Prognosis = alive 5 years 10

11 Example: Five-Year Survival The five-year survival rate for women with localized (stage I) breast cancer 1940s: 78% Now: 97% key_statistics_for_male_breast_cancer_28 11

12 Interpreting Five-Year Survival Increased five-year survival for cancer patients over time is generally inferred to mean that cancer treatment has improved and that fewer patients die of cancer Increased five-year survival, however, may also reflect diagnosing early-stage cancer and/or finding people who would never have become symptomatic from their cancer _for_male_breast_cancer_28 12

13 Surviving Five Years? Preclinical Clinical Death Disease onset Diagnosis Prognosis Did this patient survive five years? 13

14 Five-Year Survival in Screened Population Preclinical Clinical Disease onset Diagnosis Prognosis Detected by Screening Did this patient survive five years? Death 14

15 Problem of Five-Year Survival in Screened Population Diagnosis Death Disease onset Lead time Prognosis Death Disease onset Diagnosis Prognosis detected by screening If early detection is ineffective in preventing death, 15

16 Lead Time Lead time is the time between the early detection of disease (e.g., by screening) and the time of it usual clinical diagnosis Lead time bias occurs because of the failure to account for the lead time when calculating survival Some cancer screening programs were thought to improve survival until lead time bias was addressed 16

17 Issues of Five-Year Survival The measure requires five years of follow-up to know that a person survives five years Survival may reflect changes in diagnosis or treatment over time The measure is better used in an epidemiologic study, such as a clinical trial (when prognosis of subjects with different treatments are compared in similar time period over time) rather than an evaluation of a cancer prognosis over time (without comparison) Source: (JAMA 2000: 283: ) 17

18 Survival Proportion and Survival Rate Example: a study of 10 patients 4 died at the end of the five-year study period Case fatality (rate) is 4/10=40% Survival proportion is 6/10=60% This value does not consider the varying length of time that each patient was followed (alive) Survival (rate) accounts for the varying length of follow-up It is really a proportion, but it is often called a rate 18

19 Expressing Prognosis: Observed Survival Rate The observed survival (rate) is an estimate of the probability of surviving (Cumulative) probability of surviving can be calculated using the technique of life table or Kaplan-Meier Survival curve plots percent survival (cumulative probability of survival) by time (time since the beginning of study) 19

20 Male Survival by Race or Ethnicity, SEER ( ) All cancers Lung cancer Colorectal cancer Prostate cancer Source: 20

21 Expressing Prognosis: Median Survival Time Median survival time is the length of time that half of the study population survives 21

22 Median Survival Time Percent surviving 100% 75% 50% 25% 0% Years of follow-up 22

23 Comparison of Two Survival Curves 100% Series 1 Series 2 90% Percent surviving 80% 70% 60% 50% 40% 30% Series 1 Series 2 20% 10% 0% Years in study 23

24 Issues with Observed Survival Deaths from diseases other than the disease of interest are not excluded from the calculation of observed survival As the result, observed survival value will be underestimated (lower) Need to adjust the observed survival by removing the effect of other causes 24

25 Expressing Prognosis: Relative Survival Rate Relative survival rate is the ratio of the observed survival (rate) to the expected survival (rate) It compares survival in the study group (e.g., cancer) to the survival of a comparable group without the disease of interest It removes from the observed survival the effect of deaths from all other causes Comparison group could be persons in the general population similar to the patient group with respect to age, sex, race, and calendar year of observation, and free of disease of interest, such as free of cancer Its value can be above 100% Suggesting that observed survival is better than the survival expected from the general population Source: 25

26 Observed vs. Relative Survival Rates: Cancer, All Sites 100% Expected Survival Rate Observed Relative 0% Years after Diagnosis 26

27 Survival Rates by Age for Patients with Colon Cancer SEER Age at Diagnosis Five-Year Survival Rate Observed Relative

28 Review List measures of prognosis What is the problem with the use of observed survival? Are the following measures a rate, a ratio, or a proportion? Case fatality Five-year survival Observed survival Relative survival 28

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