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Establishing

Work-Relatedness of a
Disease
Marissa G. Lomuntad-San Jose, MD, MOH

Objectives
At the end of this session, participants
will be able to:
Discuss the factors that
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.

2.

Cause-effect relationship between


disease and an agent or conditions in
the workplace may not be clear
Occupational disease may be slow to
develop

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Why Establishing Work-Connection


of Disease is Difficult?
3.

4.

symptoms of disease may be


confused with changes that are due to
the aging process, or with the effects
of smoking or alcohol abuse
Information on past work exposures
often unavailable, inadequate, or
incomplete

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Why Establishing Work-Relatedness


of Disease is Difficult?
5.

6.

not all individuals react in the same


way to similar exposures to diseaseproducing agents
off-the-job exposures may contribute
or be a primary cause of illnesses and
accidents

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Six Basic Steps


1.
2.
3.

consideration of evidence of disease,


consideration of epidemiologic data,
consideration of evidence of
exposure,

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Six Basic Steps


4.
5.

6.

consideration of validity of testimony,


consideration of other relevant
factors, and
evaluation and conclusion.

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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.

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

1.

Evidence of Disease

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Occupational History

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

1.

Evidence of Disease

Generally, a medical evaluation should


include: (cont)

a laboratory evaluation (analysis of the


results of specific tests).

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

1.

Evidence of Disease

Other work-related medical


information
timing of symptoms
existence of symptoms in co-workers

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

1.

Evidence of Disease

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
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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.

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Epidemiology

3.

Point to high PROBABILITY or


ASSOCIATIONS of agents/ factors with
certain diseases
Studies
Demonstration of effects after (prolonged)
exposure
Descriptive accounts of observed effects

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

EPIDEMIOLOGICAL
APPROACH TO DISEASE
CAUSATION
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Disease Causation

Ex. foodborne disease outbreak

(Salmonella diarrhea)

Sufficient causes:

chicken salad and cream desert

Necessary cause:

Salmonella spp.

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Causes of Tuberculosis
Sufficient Causes
malnutrition

Necessary Cause

Mycobacterium tuberculosis

genetic factors
EXPOSURE TO
BACTERIA

SUSCEPTIBLE
HOST

crowded
housing

TISSUE
INVASION

INFECTION

TUBERCULOSIS

poverty
RISK FACTORS FOR TUBERCULOSIS

MECHANISMS FOR TUBERCULOSIS

Causal Inference
Process of
determining whether
observed
associations are
likely to be causal

A. Bradford Hill
(1897-1991)

Commonly used
approach on causal
inference using a set
of considerations
for causation is
Hills criteria

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Considerations for Causation


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
RELATION

Does the cause precede the effect ?

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?


Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

Strength
(What is the strength of association between the cause and effect?)

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
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

Consistency
(Have similar results been shown in other studies ?)

Different studies showing similar


findings in different populations under
increase the credibility of causal
finding

Examples:

Pesticide exposure and neurotoxicity

Organic solvents and neurotoxicity

Hypertension and noise


Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

Specificity
(Is the effect from only one cause?)

Showing that an
outcome is best
predicted by one
factor adds
credibility to a
causal claim

Ex. Silica and


Silicosis

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Temporal Relationship
(Does the cause precede the effect ?)

The disease follows after exposure and


with an appropriate time interval

Ex. Person smoking for many years


results to his being diagnosed with cancer

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Dose-Effect Relationship
(Is increased exposure to the possible cause associated with increased effect?)

The greater the level of exposure, the


greater the prevalence of severity of
disease

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Biological Plausibility
Is association consistent with other knowledge? (evidence from animal studies)

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


Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

Coherence
Is association coherent/do not conflict with other knowledge?

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.

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

4.

Validity of Testimony

Non-professional persons cannot be


expected to collect and evaluate all of
the information needed.

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

4.

Validity of Testimony

physicians will provide testimony on


medical conditions and laboratory and
other medical tests
industrial hygienists will testify
concerning evidence of exposure

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

4.

Validity of Testimony

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Validity of Testimony

4.

The examiner, board, commissioner, or


officer should verify:

the professional qualifications of those


testifying, and

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Validity of Testimony

4.

the basis of the testimony, that is, the


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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Validity of Testimony

4.

the basis of the testimony, that is, the


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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Other Relevant Factors

5.

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

6.

Conclusion

decision made would be based on


evidences presented

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

6.
1.

2.

3.

Conclusion
Has a disease condition been clearly
established?
Has it been shown that the disease
can result from the suspected
agent(s)?
Has exposure to the agent been
demonstrated? (by work history,
sampling data, expert opinion?)
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

6.
4.

Conclusion
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?)

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

6.
5.

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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

6.
6.

Conclusion
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.
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

6.
7.

Conclusion
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?

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Summary of Determining WorkRelatedness of Disease

Determination of accurate diagnosis


Occupational history/ Description of
working conditions

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Summary of Determining WorkRelatedness of Disease

Literature review of materials/


substances used in work processes
Information on dose-response
relationship

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Remember!!!!

Evaluation of diseases for workrelatedness 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

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

Remember!!!!

The concept of disease aggravation


from work exposure should be
considered in the medical assessment
for work-relatedness

Department of Labor and Employment


OCCUPATIONAL SAFETY AND HEALTH CENTER

THANK YOU!
Department of Labor and Employment
OCCUPATIONAL SAFETY AND HEALTH CENTER

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