Establishing WorkRelatedness of A Disease

Establishing
Work-Relatedness of a
Disease
Darryl Lucian S. Bautista, MD, DPCOM
Objective
At the end of this session, participants will
be able to:
 Discuss the difficulty in establishing work-
connection of diseases
 discuss the evidence-based approach in
establishing work-connection of diseases
Department of Labor and Employment

OCCUPATIONAL SAFETY AND HEALTH CENTER
Why Establishing Work-Connection of
Disease is Difficult?
1. Cause-effect relationship between
disease and an agent or conditions in the
workplace may not be clear.
2. Occupational disease may be slow to
develop.

Why Establishing Work-Connection of
3. Symptoms of disease may be confused
with changes that are due to the aging
process, or with the effects of smoking or
alcohol abuse.
4. Information on past work exposures often
unavailable, inadequate, or incomplete.

Why Establishing Work-Relatedness of
5. Not all individuals react in the same way
to similar exposures to disease-producing
agents.
6. Off-the-job exposures may contribute or
be a primary cause of illnesses and
accidents.

Decision-Making
 decision must be based on an evaluation
of the available information
 an equitable decision is likely to result
when:
 appropriate evidence is presented in a logical
and orderly sequence
 major issues are identified, and
 the basis for any presumption is defined

Six Basic Steps
1. consideration of evidence of disease,
2. consideration of epidemiologic data,
3. consideration of evidence of exposure,

Six Basic Steps
4. consideration of validity of testimony,
5. consideration of other relevant factors,
and
6. evaluation and conclusion.

1. Evidence of Disease
 The first consideration:
 that a disease condition does, in fact, exist,
and
 that the particular manifestations of the
disease appear to be the result of exposure to
a specific harmful agent.

 Generally, a medical evaluation should
include:
 An analysis of the employee's medical,
personal, family, and occupational histories;
 a thorough physical examination and clinical
evaluation (analysis of signs and symptoms);

and

Occupational History
Patient Name / Number
Occupational History: List the jobs you’ve had since you first started working. Include the years worked at each job. Also include
any military service.
Date Employer Name: Job Title and specific Major Exposures (such as Protective Equipment
Product or Services Duties chemicals, noise, (such as respirator,
Provided repetitive motion, stress) earplugs, or gloves)
Example: Acme industries; shoe Inspector Shoe polish, solvents, Respirator, earplugs
1987 - 1989 polish manufacturer trichloroethylene

Factors Affecting Validity of
Occupational History
 Occupational history may be insufficient
 Lack of specificity about the identity of
hazards
 Inadequate information about exposure
level
 Recall biases
 Other biases - e.g. fear of job loss

 Generally, a medical evaluation should
include: (cont)
 a laboratory evaluation (analysis of the results
of specific tests).

 Other work-related medical information
 timing of symptoms
 existence of symptoms in co-workers

Inquiry on timing of symptoms:
1. Change in the symptoms during the work day
2. Change in symptoms over the work week
3. Change in symptoms on weekends and on
vacation
4. Onset of symptoms away from work
5. Other work-related experiences

Example: Occupational
Asthma
Initiated or provoked by agents found in the work environment
causing asthmatic signs and symptoms
either due to excessive concentrations of these agents
or because of exaggerated response by the individual worker

Considerations
• Presence of asthma-causing agent in the
workplace
• No previous history of asthma prior to
exposure
• Improvement in symptoms with cessation
of exposure

Considetations
• Recurrence of symptoms upon returning
to work
• Worsening symptoms toward end of week
or start of week

2. Evidence of Exposure
 The best evidence to confirm the exposure
of a worker to an agent is measurements
(such as air samples, noise levels or
radiation measurements) obtained at the
worker's actual job stations, past and
present.

2. Evidence of Exposure
 Identification of agents/ factors that a
person has been exposed to
 Information from industrial hygiene studies
 Data on work exposure evaluation
 Work environment condition

3. Epidemiology
 The study of distribution and determinants
of health-related events in specified
populations.
 Concerned not only with illnesses, injuries
and death, but with means to improve health

3. Epidemiology
 Point to high PROBABILITY or
ASSOCIATIONS of agents/ factors with
certain diseases
 Studies
 Demonstration of effects after (prolonged)
exposure
 Descriptive accounts of observed effects

EPIDEMIOLOGICAL
APPROACH TO DISEASE
CAUSATION
Disease Causation
 CAUSE (of disease) – event, condition,
characteristic or combination of these
factors which plays an important role in
producing health outcome
 SUFFICIENT cause - produces or initiates an
outcome
 NECESSARY cause – must be present for an
outcome to occur

Disease Causation
 Ex. tuberculosis
 Sufficient causes:
 Host with low immune system due to
malnutrition secondary to poverty
 Necessary cause:
 Mycobacterium tuberculosis

Causes of Tuberculosis
Sufficient Causes Necessary Cause
Mycobacterium tuberculosis
malnutrition genetic factors
EXPOSURE TO TISSUE
BACTERIA INVASION
SUSCEPTIBLE
HOST INFECTION TUBERCULOSIS
crowded
housing poverty
RISK FACTORS FOR TUBERCULOSIS MECHANISMS FOR TUBERCULOSIS

Causal Inference
“Process of determining
whether observed
associations are likely to
be causal”
 Commonly used approach
on causal inference using
a set of “considerations for
causation” is Hill’s criteria
A. Bradford Hill
(1897-1991)
Considerations for Causation
(Hill’s Criteria)
1. STRENGTH What is the strength of association between the cause and
effect?
2. CONSISTENCY Have similar results been shown in other studies ?
3. SPECIFICITY Is the effect only from one cause?
4. TEMPORAL Does the cause precede the effect ?

RELATION
5. DOSE-RESPONSE Is increased exposure to the possible cause associated with
increased effect ?
6. PLAUSIBILITY Is association consistent with other knowledge? (evidence from
animal studies)
7. COHERENCE Is association coherent (do not conflict) with other knowledge?

(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Strength
 Strength of association between possible
cause and effect is measured by risk ratio
 Strong association (risk of >2) is
More likely to be causal than weak
association
 Ex. The lung cancer rate for smokers is about
10 times (RR = 10) higher than for non-
smokers

(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Consistency
 Different studies showing similar findings
in different populations under increase the
credibility of causal finding
 Examples:
 Pesticide exposure and neurotoxicity
 Organic solvents and neurotoxicity
 Benzene and leukemia

(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Specificity
 Showing that an
outcome is best
predicted by one
factor adds credibility
to a causal claim
 Ex. Silica and
Silicosis

(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Temporal Relationship
 The disease follows after exposure and
with an appropriate time interval
 Ex. Person smoking for many years results

to his being diagnosed with cancer

(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Dose-Effect Relationship
Death
 The greater the level
of exposure, the
greater the
prevalence of severity
HEALTH EFFECT
of disease
Threshold of
Safety
INCREASING DOSE
(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Biological Plausibility
 An association is plausible/believable, and
thus more likely to be causal, if consistent
with other knowledge
 Plausible
 Benzene and malignancies
 Asbestos and mesothelioma
 Anthrax and animal handlers
 Not plausible
 trauma and breast cancer
(Hill’s Criteria)
effect?

RELATION
increased effect ?
animal studies)

Coherence
 Clear association when it does not conflict
with what is already known
 Smoking as cause of lung cancer is based on
epidemiologic, laboratory animal,
pharmacokinetic, clinical and other biological
data. It shows that all available facts stuck
together as a coherent whole.

4. Validity of Testimony
 Non-professional persons cannot be
expected to collect and evaluate all of the
information needed.

 physicians will provide testimony on
medical conditions and laboratory and
other medical tests
 industrial hygienists will testify
concerning evidence of exposure

 epidemiologists give testimony on
epidemiologic data
 professionals must consider all pertinent
points in their area of expertise in order to
present an accurate and meaningful
evaluation of the available data

 The examiner, board, commissioner, or
officer should verify:
 the professional qualifications of those
testifying, and

 the basis of the testimony, that is, the
importance attributed to various areas of the
information reviewed, and the conclusions
that were drawn.

 the basis of the testimony, that is, the
importance attributed to various areas of the
information reviewed, and the conclusions
that were drawn.

5. Other Relevant Factors
 special circumstances
 unusual events at work that reduced the
effectiveness of protective equipment
 if the employee is a woman, are there special
risks to women from exposure to the agent

6. Conclusion
 decision made would be based on
evidences presented

6. Conclusion
1. Has a disease condition been clearly
established?
2. Has it been shown that the disease can
result from the suspected agent(s)?
3. Has exposure to the agent been
demonstrated? (by work history,
sampling data, expert opinion?)

6. Conclusion
4. Has exposure to the agent been shown
to be of sufficient degree and/or
duration to result in the disease
condition? (by scientific literature,
epidemiologic studies, special sampling,
replication of work conditions?)

6. Conclusion
5. Has non-occupational exposure to the
agent been ruled out as a causative
factor?

6. Conclusion
6. Have all special circumstances been
weighed? Were there any -unusual
events at work that reduced the
effectiveness of protective equipment?
Of ventilation? Of safe work practices? If
the employee is a woman, are there
special risks to women from exposure to
the agent? If so, this factor must be
evaluated.
6. Conclusion
7. Has the burden of proof been met - did
the evidence prove that the disease
resulted from, precipitated by, or was not
aggravated by, conditions at work?

Summary of Determining Work-
Relatedness of Disease
 Determination of accurate diagnosis
 Occupational history/ Description of
working conditions

Summary of Determining Work-
Relatedness of Disease
 Literature review of materials/ substances
used in work processes
 Information on dose-response relationship

Remember!!!!
 Evaluation of diseases for work-
relatedness must be based on sound and
logical medical and epidemiologic
evidences
 The likelihood that an illness/ disorder is
from occupation depends on the strength
of supporting evidences

Remember!!!!
 The concept of disease aggravation from
work exposure should be considered in
the medical assessment for work-
relatedness

THANK YOU!

Establishing WorkRelatedness of A Disease

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Establishing

establishing work-connection of diseases

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

 the basis for any presumption is defined

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

evaluation (analysis of signs and symptoms);

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

2. Change in symptoms over the work week

3. Change in symptoms on weekends and on

5. Other work-related experiences

Department of Labor and Employment

causing asthmatic signs and symptoms

either due to excessive concentrations of these agents

or because of exaggerated response by the individual worker

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

Department of Labor and Employment

RISK FACTORS FOR TUBERCULOSIS MECHANISMS FOR TUBERCULOSIS

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

Department of Labor and Employment

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

 Benzene and leukemia

Department of Labor and Employment

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

Department of Labor and Employment

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

 Ex. Person smoking for many years results

Department of Labor and Employment

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

3. SPECIFICITY Is the effect only from one cause?

4. TEMPORAL Does the cause precede the effect ?

Department of Labor and Employment

 Anthrax and animal handlers

3. SPECIFICITY Is the effect only from one cause?