1. Community Perspective on SIIIDR Recommendations Community Perspective on SIIIDR Recommendations Eileen Rubin Zacharias President & Co-Founder of ARDS Foundation www.ardsusa.org

2. From Active Attorney to ARDS/Sepsis Patient, in only days… 33 years old, active, independent 33 years old, active, independent Critical lower back pain Critical lower back pain PCP prescribes muscle relaxants, presuming back injury PCP prescribes muscle relaxants, presuming 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 day Progressively ill but PCP refuses office visit next day New PCP orders CBC/chest films; BP 70/50 New PCP orders CBC/chest films; BP 70/50 White count 37,500; ordered me to ER White count 37,500; ordered me to ER

3. Once Admitted… Diagnosed with Pneumonia & Sepsis; admitted to MICU Diagnosed with Pneumonia & Sepsis; admitted to MICU Intubated 2 days later Intubated 2 days later In a drug induced coma for four weeks In a drug induced coma for four weeks On the ventilator for eight weeks On the ventilator for eight weeks Both lungs collapsed twice Both lungs collapsed twice Suffered brief delirium Suffered brief delirium Developed hospital acquired infection in trach Developed hospital acquired infection in trach Ventilator Dependent Ventilator Dependent Required multiple blood transfusions Required multiple blood transfusions

5. 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.

6. 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% of the almost 200,000 ARDS patients diagnosed each year in the USA survive, most are told there is little hope of survival at some point.

7. Cost/Benefit Analysis How much risk is reasonable to ask of a critical care patient in a drug induced coma when that patient is incapable of consenting for themselves? How much risk is reasonable to ask of a critical care patient in a drug induced coma when that patient is incapable of consenting for themselves?

8. Consent for critical care patients When a patient is so critically ill, it is essential that next of kin are: Properly advised regarding all aspects of the research study and fully explained the consent form. Properly advised regarding all aspects of the research study and fully explained the consent form. That there is no guarantee of survival That there is no guarantee of survival Approximate survival statistics even if patient does not participate in research study Approximate survival statistics even if patient does not participate in research study Re-consent when and if patient regains competency Re-consent when and if patient regains competency

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

10. Consider other groups of patients Studies show that when a patient is diagnosed with lung cancer, even if it is stage one, the approx estimated survival rate is about 5 years Studies show that when a patient is diagnosed with lung cancer, even if it is stage one, the approx estimated survival rate is about 5 years To be sure, lung cancer patients can personally consent with respect to participation To be sure, lung cancer patients can personally consent with respect to participation However, lung cancer patients can be viewed as desperate, given statistics, but their informed consent is allowed. However, lung cancer patients can be viewed as desperate, given statistics, but their informed consent is allowed.

11. Families of ARDS/ALI patients Admittedly there is a ‘desperation’ factor when next of kin is told the serious nature of ARDS/ALI Admittedly there is a ‘desperation’ factor when next of kin is told the serious nature of ARDS/ALI the patient is unable to consent at that time the patient is unable to consent at that time Circumstances would never be present to allow such a patient to consent beforehand Circumstances would never be present to allow such a patient to consent beforehand

12. What is really the difference? Next of kin of a critical care patient is given information regarding research studies as dictated for patients decided whether or not to participate Next of kin of a critical care patient is given information regarding research studies as dictated for patients decided whether or not to participate ARDS/ALI patients have at least a 50% chance of survival ARDS/ALI patients have at least a 50% chance of survival Survival usually means survival, and not just adding a few months or years-life vs death Survival usually means survival, and not just adding a few months or years-life vs death

13. Clinical Trials are Needed! The use of clinical trials is the only way to move treatment for a critical care (ARDS/ALI/Sepsis) patient forward. The use of clinical trials is the only way to move treatment for a critical care (ARDS/ALI/Sepsis) patient forward. Consent must be made through next of kin, who can knowingly decide not to participate on behalf of their loved one Consent must be made through next of kin, who can knowingly decide not to participate on behalf of their loved one

14. Important items to consider The rapid nature of critical illness decisions The rapid nature of critical illness decisions Tragedy from illness or injury can strike anyone, male or female, young or old, any race or religion Tragedy from illness or injury can strike anyone, male or female, young or old, any race or religion Burden of ALI, which is greater than breast cancer, AIDS, asthma, cervical cancer, etc… Burden of ALI, which is greater than breast cancer, AIDS, asthma, cervical cancer, etc… Critical care patients treated quickly have greater hope for full recovery Critical care patients treated quickly have greater hope for full recovery Lack of good interventions for critical illness Lack of good interventions for critical illness

15. Evidence indicates that with medical research, mortality has decreased in critical care patients. Evidence indicates that with medical research, mortality has decreased in critical care patients. From a cost/benefit analysis, medical research studies must continue even in light of the obvious inability of these patients to consent. From a cost/benefit analysis, medical research studies must continue even in light of the obvious inability of these patients to consent.

16. Anecdotal Evidence Input from ARDS Community indicates: Most patients were not offered to participate in ARDS research but if they were, would have welcomed the opportunity Most patients were not offered to participate in ARDS research but if they were, would have welcomed the opportunity Most next of kin concur that they were not offered to participate on behalf of their loved one and if they were, they also would have consented. Most next of kin concur that they were not offered to participate on behalf of their loved one and if they were, they also would have consented.

17. Families are always seeking information about Clinical Trials On a regular and consistent basis, families contact ARDS Foundation asking whether any medical research studies are being conducted and the possibility of inclusion. On a regular and consistent basis, families contact ARDS Foundation asking whether any medical research studies are being conducted and the possibility of inclusion. ARDS Network reports that patients who have ‘no hope’ of survival are not the patients who qualify or are considered for ARDSnet medical research studies ARDS Network reports that patients who have ‘no hope’ of survival are not the patients who qualify or are considered for ARDSnet medical research studies

18. Most next of kin, or survivors of ARDS, report that physician’s advised there was ‘no hope’ at some point during their hospitalization, even in light of fact that those involved in clinical research are always surprised by this fact Most next of kin, or survivors of ARDS, report that physician’s advised there was ‘no hope’ at some point during their hospitalization, even in light of fact that those involved in clinical research are always surprised by this fact Survivors and next of kin express that even if the research does not serve a direct benefit, their participation may be of value to other patients in the future. Survivors and next of kin express that even if the research does not serve a direct benefit, their participation may be of value to other patients in the future.

19. Typical ARDS Patient in ICU

20. ARDS patients in a drug induced coma usually does not report pain or discomfort. After emerging from the coma, patients mostly report discomfort. ARDS patients in a drug induced coma usually does not report pain or discomfort. After emerging from the coma, patients mostly report discomfort. The longer a patient is hospitalized, the higher the risk of complications and increased mortality. Since research began, average length of stay for a surviving ARDS patient has declined, according to ARDS Foundation’s survival registry

21. Conclusions For treatment to move forward, clinical trials are essential. For treatment to move forward, clinical trials are essential. The benefit of allowing next of kin to consent for a critically ill patients such as an ARDS/Sepsis/ALI patient who is otherwise unable to consent is greater than the risk The benefit of allowing next of kin to consent for a critically ill patients such as an ARDS/Sepsis/ALI patient who is otherwise unable to consent is greater than the risk

22. I have gone from ARDS Patient I have gone from ARDS Patient To ARDS Survivor To ARDS Survivor

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