Community PerspectiveCommunity Perspective on SIIIDR on SIIIDR

RecommendationsRecommendations

Eileen Rubin ZachariasEileen Rubin Zacharias

President & Co-Founder of ARDS President & Co-Founder of ARDS FoundationFoundation

www.ardsusa.org

From Active Attorney to From Active Attorney to ARDS/Sepsis Patient, in ARDS/Sepsis Patient, in

only days…only days… 33 years old, active, independent 33 years old, active, independent Critical lower back painCritical lower back pain PCP prescribes muscle relaxants, presuming PCP prescribes muscle relaxants, presuming

back injury back injury 5 days later, pain + difficulty breathing; no tests 5 days later, pain + difficulty breathing; no tests Progressively ill but PCP refuses office visit next Progressively ill but PCP refuses office visit next

dayday New PCP orders CBC/chest films; BP 70/50New PCP orders CBC/chest films; BP 70/50 White count 37,500; ordered me to ER White count 37,500; ordered me to ER

Once Admitted…Once Admitted… Diagnosed with Pneumonia & Sepsis; Diagnosed with Pneumonia & Sepsis;

admitted to MICUadmitted to MICU Intubated 2 days laterIntubated 2 days later In a drug induced coma for four weeksIn a drug induced coma for four weeks On the ventilator for eight weeksOn the ventilator for eight weeks Both lungs collapsed twiceBoth lungs collapsed twice Suffered brief deliriumSuffered brief delirium Developed hospital acquired infection in Developed hospital acquired infection in

trachtrach Ventilator DependentVentilator Dependent Required multiple blood transfusionsRequired multiple blood transfusions

Acute Respiratory Distress Syndrome is sudden respiratory failure due to rapid accumulation of fluids in the lungs.

ARDS is not a specific disease. It is a syndrome that occurs in response to a direct or indirect trauma.

ARDS is always a critical condition.

ARDS patients are always ventilated.

ARDS patients are always sedated and often in a drug induced coma.

ARDS occurs within 24-48 hours of admission to the hospital for what might have been a minor medical issue.

The difference between critical care patients and other patients who lack ability to consent are considerably

different.

Before the advent of ICUs, patients with ARDS did not live long enough

for organized intervention.

Even though more than 50% Even though more than 50% of the almost 200,000 ARDS of the almost 200,000 ARDS patients diagnosed each year patients diagnosed each year in the USA survive, most are in the USA survive, most are

told there is little hope of told there is little hope of survival at some point.survival at some point.

Cost/Benefit AnalysisCost/Benefit Analysis

How much risk is reasonable to ask How much risk is reasonable to ask of a critical care patient in a drug of a critical care patient in a drug induced coma when that patient is induced coma when that patient is incapable of consenting for incapable of consenting for themselves?themselves?

Consent for critical care Consent for critical care patientspatients

When a patient is so critically ill, it is When a patient is so critically ill, it is essential that next of kin are:essential that next of kin are:

Properly advised regarding all aspects of the Properly advised regarding all aspects of the

research study and fully explained the research study and fully explained the consent form.consent form.

That there is no guarantee of survivalThat there is no guarantee of survival Approximate survival statistics even if Approximate survival statistics even if

patient does not participate in research studypatient does not participate in research study Re-consent when and if patient regains Re-consent when and if patient regains

competencycompetency

Even in light of the fact that a Even in light of the fact that a patient who is critically ill often patient who is critically ill often presents a scenario of desperation presents a scenario of desperation for next of kin, if a medical research for next of kin, if a medical research study is proper and appropriate for study is proper and appropriate for such a patient, it should be offered. such a patient, it should be offered.

Consider other groups of Consider other groups of patientspatients

Studies show that when a patient is Studies show that when a patient is diagnosed with lung cancer, even if it is diagnosed with lung cancer, even if it is stage one, the approx estimated survival stage one, the approx estimated survival rate is about 5 yearsrate is about 5 years

To be sure, lung cancer patients can To be sure, lung cancer patients can personally consent with respect to personally consent with respect to participation participation

However, lung cancer patients can be However, lung cancer patients can be viewed as desperate, given statistics, but viewed as desperate, given statistics, but their informed consent is allowed.their informed consent is allowed.

Families of ARDS/ALI Families of ARDS/ALI patientspatients

Admittedly there is a ‘desperation’ Admittedly there is a ‘desperation’ factor when next of kin is told the factor when next of kin is told the serious nature of ARDS/ALIserious nature of ARDS/ALI

the patient is unable to consent at the patient is unable to consent at that time that time

Circumstances would never be Circumstances would never be present to allow such a patient to present to allow such a patient to consent beforehandconsent beforehand

What is really the What is really the difference?difference?

Next of kin of a critical care patient is Next of kin of a critical care patient is given information regarding research given information regarding research studies as dictated for patients studies as dictated for patients decided whether or not to participatedecided whether or not to participate

ARDS/ALI patients have at least a ARDS/ALI patients have at least a 50% chance of survival50% chance of survival

Survival usually means survival, and Survival usually means survival, and not just adding a few months or years-not just adding a few months or years-life vs deathlife vs death

Clinical Trials are Clinical Trials are Needed!Needed!

The use of clinical trials is the only The use of clinical trials is the only way to move treatment for a critical way to move treatment for a critical care (ARDS/ALI/Sepsis) patient care (ARDS/ALI/Sepsis) patient forward.forward.

Consent must be made through next Consent must be made through next of kin, who can knowingly decide not of kin, who can knowingly decide not to participate on behalf of their to participate on behalf of their loved oneloved one

Important items to Important items to considerconsider

The rapid nature of critical illness decisionsThe rapid nature of critical illness decisions Tragedy from illness or injury can strike Tragedy from illness or injury can strike

anyone, male or female, young or old, any anyone, male or female, young or old, any race or religionrace or religion

Burden of ALI, which is greater than breast Burden of ALI, which is greater than breast cancer, AIDS, asthma, cervical cancer, cancer, AIDS, asthma, cervical cancer, etc…etc…

Critical care patients treated quickly have Critical care patients treated quickly have greater hope for full recoverygreater hope for full recovery

Lack of good interventions for critical Lack of good interventions for critical illnessillness

Evidence indicates that with medical Evidence indicates that with medical research, mortality has decreased in research, mortality has decreased in critical care patients. critical care patients.

From a cost/benefit analysis, medical From a cost/benefit analysis, medical research studies must continue even research studies must continue even in light of the obvious inability of in light of the obvious inability of these patients to consent. these patients to consent.

Anecdotal EvidenceAnecdotal Evidence

Input from ARDS Community indicates:Input from ARDS Community indicates:

Most patients were not offered to Most patients were not offered to participate in ARDS research but if participate in ARDS research but if they were, would have welcomed the they were, would have welcomed the opportunityopportunity

Most next of kin concur that they were Most next of kin concur that they were not offered to participate on behalf of not offered to participate on behalf of their loved one and if they were, they their loved one and if they were, they also would have consented.also would have consented.

Families are always Families are always seeking information seeking information about Clinical Trialsabout Clinical Trials

On a regular and consistent basis, families On a regular and consistent basis, families contact ARDS Foundation asking whether contact ARDS Foundation asking whether any medical research studies are being any medical research studies are being conducted and the possibility of inclusion.conducted and the possibility of inclusion.

ARDS Network reports that patients who ARDS Network reports that patients who have ‘no hope’ of survival are not the have ‘no hope’ of survival are not the patients who qualify or are considered for patients who qualify or are considered for ARDSnet medical research studiesARDSnet medical research studies

Most next of kin, or survivors of ARDS, report Most next of kin, or survivors of ARDS, report that physician’s advised there was ‘no hope’ that physician’s advised there was ‘no hope’ at some point during their hospitalization, at some point during their hospitalization, even in light of fact that those involved in even in light of fact that those involved in clinical research are always surprised by this clinical research are always surprised by this fact fact

Survivors and next of kin express that even if Survivors and next of kin express that even if the research does not serve a direct benefit, the research does not serve a direct benefit, their participation may be of value to other their participation may be of value to other patients in the future. patients in the future.

Typical ARDS Patient in Typical ARDS Patient in ICUICU

ARDS patients in a drug induced coma usually ARDS patients in a drug induced coma usually does not report pain or discomfort. After does not report pain or discomfort. After emerging from the coma, patients mostly report emerging from the coma, patients mostly report discomfort.discomfort.

The longer a patient is hospitalized, the higher the The longer a patient is hospitalized, the higher the risk of complications and increased mortality.risk of complications and increased mortality.

Since research began, average length of stay for a Since research began, average length of stay for a surviving ARDS patient has declined, according surviving ARDS patient has declined, according to ARDS Foundation’s survival registryto ARDS Foundation’s survival registry

ConclusionsConclusions

For treatment to move forward, For treatment to move forward, clinical trials are essential. clinical trials are essential.

The benefit of allowing next of kin to The benefit of allowing next of kin to consent for a critically ill patients consent for a critically ill patients such as an ARDS/Sepsis/ALI patient such as an ARDS/Sepsis/ALI patient who is otherwise unable to consent who is otherwise unable to consent is greater than the riskis greater than the risk

I have gone from ARDS PatientI have gone from ARDS Patient

To ARDS SurvivorTo ARDS Survivor

After my family was told I would never After my family was told I would never breathe on my own, might suffer brain breathe on my own, might suffer brain damage, my quality of life would be damage, my quality of life would be minimal, 9 weeks later, I came home, six minimal, 9 weeks later, I came home, six months after, I became pregnant with my months after, I became pregnant with my first daughter, and 8 months after, went first daughter, and 8 months after, went back to work part time as an attorney. back to work part time as an attorney. Clinical research is so critically important Clinical research is so critically important for this extremely large patient group for this extremely large patient group even in light of an inability to personally even in light of an inability to personally consent.consent.

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