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Chapter 2 Literature Review

2.3 Stochastic Models for Disease Natural History

A sequence of random variables {ܺ,Ƚ= 0,1,…} is called a Markov chain if, for every

collection of integers, ߙ ൏ ߙǡ ൏ ڮ ൏ ߙ ൏ ߚ, the conditional distributions of

ܺఉsatisfy the relation:

ܲ൛ܺ ൌ ݅หܺǡ ǥ ǡ ܺൟ ൌ ܲ൛ܺ ൌ ݅หܺൟ, for ݅

The outcome in the future (ܺൌ ݅ሻ݅ݏ݊݋݈݋݊݃݁ݎ݀݁݌݁݊݀݁݊ݐݑ݌݋݊ݐ݄݁݌ܽݏݐݏݐܽݐ݁

ov mmmmmoododododelelelelelelelele

me me me me

mes tththththththththatatatatatatatatPPPPPPPPD D D D D D D D isisisisisisisisaaaaaaaa

sed ddddasasasasasa ssssstatatatagegeggg VVVVVVViiiiisss s s

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ǡ ǥ ܺ೙షభ

For each ܺ, the absolute probability is denoted by ܲሼܺ ൌ ݅ሽ ൌ ܽ

For every pair of random variables, andܺ, the conditional probability is denoted by

ܲሼܺ ൌ ݅Žܺ ൌ ݅ሽ ൌ ܲǤ௜ġ

The joint probabilities of ܺǡ ܺǡ ܺ, for Ƚ ൏ Ⱦ ൏ ɀ, are given by

ܲ൛ܺൌ ݅ǡ ܺ ൌ ݅ǡ ܺൌ ݅ൟ ൌ ܽܲǡ௜ܲǡ௜ǡ ܽ݊݀ ܲ൛ܺൌ ݅ǡ ܺ ൌ ݅ൟ ൌ ܽܲǡ௜

Therefore, for any collection of integers Ƚ ൏ Ⱦ ൏ ڮ ൏ Ɂ ൏ ɂ, the joint probabilities are

ܲ൛ܺൌ ݅ǡ ܺ ൌ ݅ǡ ǥ ǡ ܺൌ ݅ǡ ܺ ൌ ݅ൟ ൌ ܽܲǡ௜ǥ ܲǡ௜

A Markov chain with state space being the set of all the non-negative integers is

completely determined by the initial absolute probability distribution

ܲሼܺ ൌ ݅ሽ ൌ ܽǡ݅ ൌ ͳǡʹǡ… and the transition probabilities

ܲሼܺఈାଵ ൌ ݅ఈାଵȁܺൌ ݅ሽ ൌ ܲǡ௜ഀశభ , ݅ǡ ݅ఈାଵ ൌ ͳǡʹǡ ǥ for Ƚ=0,1,…

The transition probabilities of a time homogeneous chain is denoted by

ܲሼܺఈାଵ ൌ ݆ȁܺ ൌ ݅ሽ ൌ ܲ௜௝

The transition probability ܲ௜௝ for a three-state Markov model can be arranged in the form

of a matrix

P=൭

ܲ଴଴ ܲ଴ଵ ܲ଴ଶ

ܲଵ଴ ܲଵଵ ܲଵଶ

ܲଶ଴ ܲଶଵ ܲଶଶ

bilititititity y y y yy isisisisisddddenenotototttttedededededbbbbbbyyyyy

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2.3.2 Three-state Homogeneous Markov Model for Disease Natural History

Chen et al applied a three-state Markov model to estimate sojourn time in chronic

disease screening without data of interval cases.43They model the disease with a

continuous-time Markov process in which X(t), the state of an individual at time t, is a random variable with a state space Ω={0,1,2}, where 0 represents no disease, 1 represents

preclinical screen detective disease (PCDP) and 2 represents clinical phase (CP). The

clinical phase in this model is an absorbing state in Markov processes language because

the natural history cannot be estimated beyond diagnosis due to the effect of therapy. They

also assume this is a progressive model.

The transition rates in the three-state model can be expressed as an intensity matrix,

൭െߣ

ߣ represents the transition rate from no disease to the PCDP, ߣ represents the transition

rate from the PCDP to the clinical phase.

Given the transition intensity matrix above, transition probabilities for a three-state model

can be expressed as

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The likelihood function based on the prevalent screen in a cohort with N individuals is

ܮ

ሺǤ ሻ ൌ ෑ ൬ ܲ

଴ଵ

ሺݒ

ݒ represents age at fist screen for mth subject

ݔ ൌ ͳ when the mth subject is detected as a positive case

ݔ ൌ Ͳ otherwise.

However, as the previous mention above, the Markov model used to assume a

homogeneous process that a constant hazard rate with time for progression for state to

state. This may be unrealistic in medicine and biology.

2.3.3 Three-state Model with Weibull Distribution

In order to deal with the non-constant hazard in the stochastic model, Chen et al

propose a non-homogeneous three-state model for the disease natural history of oral

cancer.44They model the time of transitions from normal to leukoplakia and leukoplakia

to invasive carcinoma with two Weibull distributions. The transition probabilities for

staying in a no disease state (state 0), transitions from normal to leukoplakia (state 1) (2 (2 (2 (2 ( --3)3)3)3)3)

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and from normal to invasive carcinoma (state 2) in a given time interval [t1, t2] are

expression as follows:

ܲ଴଴ሺݐǡ ݐሻ ൌ ͳ െ න ݂

ሺݑሻ݀ݑ

ܲ଴ଵሺݐǡ ݐሻ ൌ ׬ ݂

ሺݑሻ ቀͳ െ ׬ ݂

ሺݒሻ†ݒቁ ݀ݑ(2-4)

ܲ଴ଶሺݐǡ ݐሻ ൌ න ݂

ሺݑሻ න ݂

ሺݒሻ݀ݒ݀ݑ

f1(t) and f2(t) are the probability density function of Weibull distributions for time of

transition from states 0 to 1 and from state 1 to 2. The two Weibull distributions are

denoted as W1ଵ଴,ߛ)and W2ଶ଴, ߛ). ߣଵ଴ andߣଶ଴ are scale parameters and ߛ and ߛ are shape parameters for the two corresponding transitions. The transition rates as a

function of time are expressed as follows:

ߣ ൌ ߣ௜଴ߛݐିଵ where i=1 or 2

The probability of remaining in state i-1 in time t is

ܵሺݐሻ ൌ ‡š’ ቄെ ׬ ߣ ௜଴ߛݑିଵ†ݑቅ ൌ ‡š’ሺെߣ௜଴ݐሻ (2-5)

The corresponding probability density function is

݂ሺ–ሻ ൌ ߣ௜଴ߛݑିଵ‡š’ሺെߣ௜଴ݐ

The transition probabilities for staying in state 1 and state 2 were also denoted as

follows:

ܲଵଵሺݐǡ ݐሻ ൌ ͳ െ ׬ ݂ ሺݑሻ†ݑ

ܲଵଶሺݐǡ ݐሻ ൌ ׬ ݂

ሺݑሻ†ݑ (2-6) al [[[[[ttttt11111, tttt ]22222]]]]]]]]ararararararararareeeeeeee

33

The natural history from state 1 (leukoplakia) to state 2 (invasive carcinoma) is usually

unobservable due to the interruption of medical treatment. We can only estimate

parameters via equation (1), P00, P01and P02.

2.3.4 Incorporation of patient specific covariates

The effect of patient specific covariates, say x, on the three-state stochastic model was

assessed by the exponential regression model that treats scale parameter in the Weibull

distribution as a function of patient-specific covariates. It is expressed as follows:

ߣ௜଴ ൌ ߣ௜଴଴‡š’ሺߚ௜଴߯

ߣ௜଴଴ : the scale parameter of Weibull distribution for state i

߯ : a vector of covariates for subject m

ߚ௜଴ : corresponding regression coefficient

2.3.5 Bayesian inversion for a non-standard case-cohort design

For an n-state disease natural history, n sets of random samples for each transition were

selected in case-cohort study design in Chen et al. Let S denoted an indicator of whether

a subject was sampled (S=1). For individual i, let ߨ be sampling fractions for state j

at time ti . ߨ was denoted as follows:

ߨ ൌ ሺ ൌ ͳȁͲ ՜ ݆Ǣ ݐ

nomommmma)aa)a)a iiiiiiss s ss sssuususususususususuauauauauauauauaualllllllllllllllllly y yyyyyyy

y y y

yeeeeestiimimimimimimimimatatatatatatatateee e e e

34

The sampling fractions for state j can be expressed as ߨ if we assume that sampling

fractions are independent of the individual. Using Bayesian inversion, the probability of

transition of being state j at time tigiven a subject was sampled is P(0՜ ݆Ǣ ݐȁܵ ൌ ͳሻ

The transition probabilities P0j(ti) are derived from equation (1).

Likelihood function, parameter estimation and model validation

The data on the first oral examination were used to estimate the parameters relate to the

disease natural history. This yields three possible observed transitions before the first

examination: staying in normal (state 0 Æ 0), normal to leukoplakia (state 0Æ 1) and

normal to invasive carcinoma (state 0 Æ 2). According to the above equation, P(0՜ ݆Ǣ ݐȁܵ ൌ ͳሻ

The likelihood function for the normal-leukoplakia-invasive carcinoma cohort with

three covariates is

age i of the first examination.

thahahahahattttt sasaaaaaampmpmpmpmpmpmpmpmplililililililililingngngngngngngngng

35

2.3.6 Five-state non-homogeneous stochastic model

Chen et al further extended the three-state model to the k-state model.45They use

normal-adenoma-carcinoma for colorectal cancer for the example. The natural history of the colorectal cancer is classified by adenoma size. The state space Ω={0,1,2,3,4},

where state 0 represent normal, state 1 represent diminutive adenoma, state 2 represent

small adenoma, state 3 represent large adenoma, and state 4 represent invasive

carcinoma. They apply the hazard rate from normal (state 0) to diminutive adenoma

(state 1) change with time and denoted as ߣሺݐሻ with Weibull distribution. The Markov

property was assumed for the remaining transition rate of ߣ to ߣdue to the

complexity of algebra increases if each transition rate is modelled by the Weibull

distribution. The natural history of the above process is divided into two parts: 1.

Non-homogeneous Markov property for the hazard rate for normal to diminutive adenoma. 2.

Homogeneous Markov property for the remaining transitions. The transition matrix is as

follows:

The time of transition from states 0 to 1 is modeled byߣሺݐሻ with Weibull distribution.

The remaining transition matrix M is as below:

d de de de

dell.4545454545454545ThThThThThThThTheyeyeyeyeyeyeyeyuuuuuuuusesesesesesesese

nattturururururralalalalalhhhhisistotoryryryryryr

36

As the non-homogeneous part that models the hazard rate of the onset of diminutive

adenoma with a Weibull distribution, the transition probabilities from state 0 (normal) to

state 1-4 can be derived as follows.

The probabilities for subjects staying as normal during [t1, t2] is

ܲ଴଴ሺݐǡ ݐሻ ൌ ͳ െ ׬ ݂ ሺݑሻ݀ݑ

(2-10)

݂ሺݐሻ : the probability density functions of Weibull distribution for the transition from

state 0 to 1

The probabilities for an individual progressing from state 0 to state j during [t1, t2] is

ܲ଴௝ሺݐǡ ݐሻ ൌ ׬ ݂ ሺݑሻ ൈ ܲଵ௝ሺݑǡ ݐሻ݀ݑ

(2-11)

j=1,2,3,4; ܲଵ௝(.): transition probabilities derived from ܲ௜௝ሺܽǡ ܾሻ

According to the equation as below, P(0՜ ݆Ǣ ݐȁܵ ൌ ͳሻ

The likelihood function for adenoma-carcinoma is ς ൬σబబሺ௧

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2.3.7 Semi-Markov Model

To consider death as an absorbing state, the five-state Markov model (Figure 4-2) is

extended to the following model.

As the transition from the current sate to the next state, particularly absorbing state i.e.

death, is highly dependent on how long they stay in the current stat, a six-state

semi-Markov model will be proposed to model the temporal natural history of H-Y based PD.

State space Ω, Ω={0,1,2,3,4,5} is defined similarly as above. Let X={X0, X1,,…, Xn}

denote n observed successive transitions for an individual during a period of time t, where

X0is the initial state and Xnis the X final state after n transitions. We assume the total number of transition is finite and XאΩ. As a six-state semi-Markov process will be

applied, in addition to X, which is said to form an embedded Markov chain, we still Free of PD

38

require sojourn time distribution to depict the time spent in the current state before

transition to the next state. In parallel with X, T= {T0, T1, …Tn} is denoted to represent the

entry time into state Xnafter n transitions. According to X and T, a semi-Markov process

can be formed by transition probabilities (Pij) and distribution of sojourn time (Fij(t))

expressed by

௜௝ ൌ ሺܺ௡ାଵ ൌ ݆ȁܺ ൌ ݅ሻ (4-7)

௜௝ is a homogeneous process

ܨ௜௝ሺ–ሻ ൌ ሺܶ௡ାଵെ ܶ ൑ ݐȁܺ௡ାଵൌ ݆ǡ ܺ ൌ ݅ሻ

For example, the transition from SD early H-Y stage (I&II) (j=1) to death (j=5) is

determined by the transition probability (P15) and also the distribution for the time spent in

early SD H-Y stage F15(t).

Fij(t) is specified by a generalized Weibull distribution expressed by ܨ௜௝ሺ–ሻ ൌ ͳ െ ‡š’ ൬െ ൬

೔ೕ೔ೕ൰ (4-8)

The parameters of ɐ and ɋ can change with time.

ߥ௜௝ and ߪ௜௝are estimated using the maximum likelihood method.

Suppose we have N individual (m=1,…..N) and the subject m had nmsuccessive

transition. The observed sequence is denoted as {߯ǡ ǥ ߯ሽ and the corresponding entry

times into state X is denoted by {ܶǡ ܶǡ ǥ ǡ ܶ೘శభሽ.

The likelihood function

statatatatateee e e bebebeeeeeeefofofofofofofofoorererererererere

ot ot ot ot

otededededddddttttttto o oooooorererererererereprprprprprprprpresesesesesesesesenenenenenenenentt t tt tt ttthththththththehe

i-MaMaMaMaMaarkrkrkrkrkovovovovo pppproooooocececececesssssssssss

39

ሺɐǡ ɋሻ ൌ ς௠ୀଵሼς௟ୀଵሺܲ೗షభ ݂೗షభ ሺܶെ ܶ௟ିଵ ሻ ൈ σ௃ஷ௫೙೘ ܲ೙೘ ܵ೙೘ ሺܶ೘శభ

ܶ೙೘శభ (4-9)

The latter part is related to right censoring with censoring indicator of Ɂ ߜ೘శభ ൌ ͳ if ܺ is not final state

ߜ೘శభ ൌ Ͳ otherwise

2.4 Covariates associated with the progression of