Session 2 6 - horneland am - evidence based risk assessment - the noble art of extrapolation -...

Department of Occupational Medicine

Evidence based risk assessment

- the noble art of extrapolation

Alf Magne Horneland

Director NCMM

Head Appelate Body NMA


Purpose of medical selection

• To avoid unacceptable safety risk to

– The individual him/her-self

– Other persons on board

– The safe operation of the installation

• Due to a medical condition

• Or physical or mental capacity

Department of Occupational Medicine Definition

• Selection of individuals

• To carry out specific

tasks

• Based on medical

assessment of fitness

• According to certain

standards

Department of Occupational Medicine Different view angles – different hats

General practitioner:

Health legislation

The individual’s best

PATIENT

Company doctor:

Working environment legislation

Sound working environment

Employee/worker

Petroleum doctor:

Health requirements regulations

Fitness for work

Candidate

National social insurance doctor:

National Insurance Act

Rights

Client

Insurance company doctor:

Private Law Contracts

Rights

Contracts

Department of Occupational Medicine The different roles of doctors

Petroleum doctor Company doctor General practitioner

Role Control Prevention Treatment

Fokus (Fitness for work) /

absense of disease

Working environment

/ Occupational

injuries and diseases

Individual health

Perspective Maximum two years

ahead

Past, present and

future

(Past), present and future

Tools Medical selection in

relation to

requirements

Environmental

factors affecting the

worker

Medical treatment of

illness and injuries

Aim Contribution to the

safety of the working

environment

Prevent occupational

injuries and diseases

Prevent and treat disease

regardless of cause

Acts Petroleum Act Working Environment

Act

Health and Care Act

The

individual:

A Candidate An employee/worker A Patient

Department of Occupational Medicine Wearing many hats

• How many hats do you wear?

• Which of them do you carry today?

• Which is on top and is most important?

• How do you handle 3-4 different simultaneous viewpoints in the same case?

• How do you handle information you have got earlier as a GP when the individual now seeks you as e Petroleum doctor?

• Is the individual aware about the doctor’s roles, and which of them the doctor has at the consultation –

– Petroleum doctor

– GP

– Company doctor

– Etc.


Consequence

Likelihood

Insignificant = 1 Significant = 2 Serious = 3

Very low = 1

(< 2% per year)

Acceptable risk

(1)

Acceptable risk

(2)

Acceptable risk

(3)

Low = 2

(2-5 % per year)

Acceptable risk

(2)

Acceptable if

mitgated

(4)

Acceptable risk if

mitigated

(6)

Moderate = 3

(5-10% per year)

Acceptable risk

(3)

Acceptable if

mitigated

(6)

Unacceptable risk

(9)

High = 4

(> 10 % per year)

Acceptable risk if

mitigated

(4)

Unacceptable risk

(8)

Unacceptable risk

(12)


A. Identify which medical incidents that could occur based on the underlying condition.

B. The likelihood for such incidents

A. Likelihood in the group to which the individual belongs

B. Individualization of likelihood

C. Job-related consequences

A. For him/herself

B. For others on board

C. Of the installation/operation

D. Risk calculation

E. Mitigation measures

F. Risk evaluation

G. Conclusion and justification

A. Which incidents should be expected based on the

underlying condition? • Possible medical incidents that should be

expected based on underlying disease.

– Syncope, infarction, seizures, thrombosis,

bleeding, paralysis, psychotic relapse,

depression, anxiety, etc.

• Which can lead to:

– Impaired physical function

• Reduced muscle strength, tempo,

coordination etc.

– Impaired mental function

• Memory, awareness, powers of reaction,

concentration, prioritizing, sense of reality,

depression, delusions, hallusinations, etc

Department of Occupational Medicine B: Assessment of likelihood

• General assessment of likelihood based on knowledge about the condition – Evidence on the medical condition

– Review articles

– Look for • Natural course and course on treatment

• Prognosis

• Complications

• Effectiveness of treatment

• Adverse affects of treatment

• Need for follow-up

• Individualization of likelihood based on knowledge about the individual – Individual factors that modify the average of the group

– Age, sex

– General condition

– Comorbidity

– Stage and severity of the disease

– Duration of disease

– Time of observation

– Effectiveness of treatment

– Follow-up needs and possibilities etc.





C. Job-related consequences A. For him/herself



D. Risk calculation


F. Risk evaluation


Department of Occupational Medicine C. Job-related consequences

• Knowledge about the working place – Which job?

– Which job tasks?

– The nature of the working place?

– Are there others having a similar job?

– Time factor?

• What will happen when an incident occur? – Harm to the person him/her-self

• Falling from ship’s mast, down stairs, over railing, over board?

• Harm form dangerous machinery / tools

• Self-harm due to serious psychiatry

• Illness cannot be treated in due time

• Death

– Harm to others • Harm to others due erroneous judgement and actions

• Overburdening others due to impaired function

– Harm to installation or operation • Damage to machinery due to erroneous judgement and actions or

impairment of function

• Operational harm due to erroneous judgement and actions or impairment of functions

– Other consequences • Environment, society, population, other installations, etc.

• Judgment must include ordinary as well as emergency situations





C. Job-related consequences

A. For him/herself



D. Risk calculation


F. Risk evaluation


Department of Occupational Medicine D: Risk Calculation

• We are not only interested in the likelihood for a medical

incident to occur, based on underlying disease

• We want to assess the job-related consequences the

medical incident could have, for

• Safe operation of the installation

• Others on board

• The person him/herself

Individual likelihood x Consequence in job = Risk








D. Risk calculation


F. Risk evaluation


Department of Occupational Medicine E. Mitigating measures

• Compensation/mitigation of risk

• May result in an assessment of acceptable risk, even if unacceptable without compensatory mechanisms

• Examples – Medicines

• Personal (i.a. Antihypertensives)

• Contingency measures (ex. Adrenaline / Vit. K?)

– Glasses, lenses / extra glasses

– Hearing aid, extra alarm in cabin

– An extra man on work

– Restrictions of in job tasks

– Restrictions of working place, area

– Duty to inform employee/superior

– Compulsory specialist control

– Compulsory reporting

– Time limitation

– Etc.

• What if the compensatory measures fail?








D. Risk calculation

E. Mitigating measures

F. Risk evaluation


Department of Occupational Medicine F. Risk evaluation • Individualized calculated risk

• + possible mitigating factors

• Should be evaluated in relation to the statutory

standards and criteria

– Regulations / guidance

– If lacking guidance:

• Evaluate analogously

• Best clinical practice

• Evidence

• Purpose of the regulations

– Unrestricted health certificate?

– Time limitaionts?

– Other restrictions?

• Can only be set by the CGR

– Unfitness?

• Is there more to consider prior to concluding?








D. Risk calculation

E. Mitigating measures

F. Risk evaluation










D. Risk calculation


F. Risk evaluation



• Decision in writing

• Justification of decision in writing

• Justification should include

– Medical condition

– Likelihood for an incident

– Consequence of incident in his/her job

– Assessment of compensatory measures

– Risk evaluation, refer to statutory basis

– Conclusion

• If restrictions needs: Send the case to the CGR

• If time limitations needed: Issue time limited health

certificate

• If no restrictions or limitations needed: Issue

unrestricted health certificate

• If certificate of unfitness is to be issued – inform about

complaints procedures.


«Good» and «bad» justifications «Good» justifications can be re-examined by another doctor

• Because the likelihood for a serous condition is low and the consequences of an incident implies a low safety risk in his work as a cleaner

• Because his physical condition (se test results) is sufficient to all ordinary and emergency duties, despite his overweight

• He is physically fit, despite his overweight, is within the recommended limits for body weight and waist circumference, and there is no medical condition with increases the likelihood for an acute incident

«Bad» justifications cannot be re-examined by another doctor

• Seems to be fit

• Find him fit

• Conclude that his health condition is good enough

• My overall assessment is…

• Does not have higher risk than others with the same condition

• Not higher risk at sea than on shore


Justification – check list

Describe your sequence of thought

A. Possible medical incidents that could occur based on the underlying disease

B. Likelihood for such incidents A. Evidence-based likelihood for the diagnostic group

B. Individualization of the likelihood

C. Consequences in the job situation A. For him/herself


C. For the installation / operation

D. Risk calculcation

E. Possible mitigation of risk

F. Risk evaluation



General Risk Assessment Sources

Review articles • UpToDate:

www.uptodate.com – More than 260.000 references

– More than 80.000 articles

– General reviews of conditions and diseases,

as well as overview of mor specific topics

• Cochrane Summaries:

http://summaries.cochrane.org/ – May be too specific on different matters, not general

review articles,

CLINICAL PRACTICE • BMJ Best Practice:

http://bestpractice.bmj.com – Written for general practitioners

• BMJ ClinicalEvidence:

http://clinicalevidence.bmj.com/x/index.html – Effects and adverse effects of treatment for

more tahn 250 conditions

RESEARCH ARCITLES:

• PubMed:

http://www.ncbi.nlm.nih.gov/pubmed – Database developed by «the National Center

for Biotechnology Information» (NCBI) in

«National Library of Medicine» (NLM), one of

«the National Institutes of Health» (NIH) in

USA, mostly based on Medline.

• Medline

http://www.nlm.nih.gov/bsd/pmresources.ht

ml – Medical database in NLM, with more than 19 mill.

references. Basis for PubMed

INFORMATION REGARDING

MEDICINES: • Lexicomp med Martindale:

http://online.lexi.com/lco/action/home/switch

?siteid=298

http://www.uptodate.com/

http://summaries.cochrane.org/

http://bestpractice.bmj.com/

http://clinicalevidence.bmj.com/x/index.html

http://www.ncbi.nlm.nih.gov/pubmed

http://www.ncbi.nlm.nih.gov/pubmed

http://www.nlm.nih.gov/bsd/pmresources.html



http://online.lexi.com/lco/action/home/switch?siteid=298

http://online.lexi.com/lco/action/home/switch?siteid=298


Likelihood for undesirable medical events in

different diseases/conditions

• You want to know:

– The likelihood for a medical incident leading to the worker

becoming

• A danger to others

• A danger to him/her-self

• Occupies medical treatment capacity

• Must be replaced by new crew members

• Needs medical evacuation (MEDVAC)

• In a time perspective equal to the validity period of the certificate

• Usually this is not to be found in any scientific medical

studies.


Which conditions do we talk about?

• Physcial capability reduction

• Mental capability reduction

• Obvious examples:

– Syncope / epileptic fits / TIA / thrombosis / embolus / myocardial

infarction / cerebral bleeding / serious arrytmia

• However – do not forget the following examples:

– Reduced agility / reduces concentration / depression / anxiety /

manias / delusions / hallusinations / relapse with drug and

alcohol abuse / reduce impulse control / reduced awareness /

difficulties in ranking priorities / reduces vision and hearing /

breathing problems / headache / pain conditions / etc.


What do you find in the studies?

• Time perspective: 1 yrs, 5 yrs, 10 yrs, 15 yrs ...

• readmissions, reoperations

• reinfarctions og other «re» end-points

• Death, survival

• Only a few discuss likelihood within 2 years for an incident leading to unfitness for work, risk to self or to others or to operation of the installation.

• Individualization on the basis of a general assessment of likelihood is necessary – and very difficult.


Dangers of extrapolation

• Studies includes 70-years old individuals

• Studies done in USA or ASIA

• Studies including women only

• Studies done over 5-10-15-20 years

• Studies with endpoints like death,

survival, readmissions, reoperations,

reinfarctions etc.

• What about 40 years old?

• What about Norther Europe?

• What about men?

• What about 1-2 years?

• What about the risk for:

– Not managing his/her job?

– Becoming dangerous (psychosis)

– Human error due to lack of

concentration, hypoclygemia,

drowsiness, distraction, amnesia?

– Not being able to hear or see alarms

– Not understanding communication

– Needing medical treatment

– Needing MEDEVAC

– Overburdening fellow crew members

– Need for replacement

– Risk for the individual him/her-self?

Session 2 6 - horneland am - evidence based risk assessment - the noble art of extrapolation -...

Health & Medicine

Transcript of Session 2 6 - horneland am - evidence based risk assessment - the noble art of extrapolation -...