Tony Wolff:
Having had an HIV test can seriously effect a persons chances of getting life insurance, a mortgage or health insurance etc. Thus here in the UK to justify the testing of a patient who is unable to consent we must be able to demonstrate that the result of the test has the potential to significantly alter their short term management. Exactly under what sort of circumstances do people think knowledge of a patients HIV status effects their ICU management?
DJ Muckart:
We have looked at this in the King Edward VIII ICU. The prevalence of HIV in our environment is now about 30%. We felt that we were becoming potentially biased against positive patients so looked at it prospectively. The Ethics committee agreed to waive the patients' right to informed consent because of the possible impact of the study to society. We tested all admissions and were blinded to the HIV status during the patients ICU stay. Patients were advised of the study after discharge and were allowed to decide if they wanted the result. (Sorry to go on about this but it has relevance later).
402 patients : 52 HIV positive (study was 3 years ago hence lower incidence as to now)
Results: No significant difference in mortality between HIV positives and negatives. There was a significantly higher incidence of organ dysfunction and septic shock in HIV positives which did not impact on outcome - is HIV protective in part?
Ethics: The study was presented at the European ICU Congress in Athens and the abstract published in Int Care Med (Bhagwanjee S, Muckart D, Jeena P, Moodley P. 1995;21(Supplement): S95). The journal then refused to publish the final paper on the basis of the ethics of the study.
It should be emphasised that no patient had AIDS and all critical illnesses were non-HIV related - mainly trauma.
We have stopped testing unless we think they may have AIDS but we have had a couple of these surviving as well. I don't think the HIV test impacts on treatment - we would withdraw for the same reasons as in HIV negative patients.
Nick Macartney:
Tony asks about HIV testing of ICU patients. Fortunately in the leafy suburbs we do not get as much overt HIV positivity- IV abusers for instance are rare. My immediate response was "never". How does it help? If the patient has PCP, I would assume positivity in the face of a negative result anyway. I do not think that the test will alter my management in any way, so I would not waste money doing a test of no obvious benefit to the patient.
Dick Burrows:
There was an interesting letter in the Lancet recently regarding what they termed "The ethical type II error" (V347, 1996)
The author felt that "although ethics committees were very effective at preventing "unethical" trials they do seem prone to an ethical type II error. .. These committees should be concerned about the potential implications of findings that were not made because of there intervention.....Tackling this issue needs "ethical common sense""
I suspect that, as the patients would not be given the result if they did not want it (and the results were confidential), Intensive Care Medicine may have made a "type II ethical error".
I'm somewhat worried about the implications of this. I appreciate the need to understand patterns and outcomes of disease and the need for research in order to make rational decisions as to patient interventions, non interventions, allocation of resources etc. It may be necessary to waive consent and, in fact, we often do things from day to day without the explicit consent of the patient. To require explicit consent in respect of every little thing would make the job unworkable. Trust in you to "do the right" thing has to be part of the job.
Thought should be given to the possible outcomes of any research project and to the possible implications of the use of the information. If it was found that HIV did have an adverse outcome in multiple trauma etc how then would that information be used. Would the administrator, or yourself for that matter, use the information to justify the removal of resources away from HIV patients or into research for HIV etc. If you were to use the information as a reason to DNR then why should an HIV patient be any different from a cancer patient - in fact as life is a terminal disease why should the HIV patient be different from anybody else.
You do not have an absolute right to knowledge in the pursuit of science or economics. The exercise must be limited by respect for other rights - the right to consent being one of these other rights. Neither is autonomy, on which consent is based, an absolute right - which is what we have discussed on many occasions in respect of futility of treatment.
It is a very tricky exercise but in general I would say your justification in testing for HIV for purposes of research without the consent of the patient is questionable because I don't think it would have really made much or any difference to your approach to the patient. In a sense you were lucky that the research showed no difference!
Because I know the people involved to be amongst the most highly principled and ethical people that I know I personally have no problems with them but if I didn't know them...
I doubt the journal put any real thought into the rejection and having been priviledged to see the reasons for rejection I now know they didn't put any thought into it.
Rolando Berger:
I thoroughly agree with Dick Burrows' point about research without consent: it is not only WHAT you are researching, or WHY (what for) are you researching it, but also (and sometimes most important of all), HOW ELSE could/would what you have researched (without consent) be used by others.
In the arena of HIV testing in the ICU for clinical (not research) reasons, I personally have no problems testing without consent, (ethical problems, that is; legal ones can be a bird of a different feather), if I judge this information to be important to make a sound clinical decision to the benefit of the patient at that point in time. This situation does not come up very often at all... but it does so on rare occasions. A case I had a few months ago comes readily to mind: A young man with high-fevers, purulent sputum, bilateral pulmonary infiltrates, very confused, and with profound hypoxemia, was admitted to ICU and promptly found to have WBCs, Gram positive cocci and lots of yeast (grew Torulopsis Glabrata) in his sputum (obtained by NT suction). Once he was found to be HIV +, I also treated the Torulopsis and added PCP coverage and steroids, while obtaining a few additional tests and waiting for the "dust to settle". Eventually his CDC4 count came back below100, and PCP was confirmed in a suctioned sputum sample (obtained after intubation). Of course I could have done the same things without the HIV test, but given the very low prevalence of de novo HIV disease in our area, I would be "wrong" 90% of the time if I routinely took an empirical approach in this scenario..... and I do not think that empirically giving Ampothericin B, high-dose IV cotrimoxazole, and steroids, to all life-threatrening, bilateral community-acquired pneumonias in non-AIDS patients is such a hot idea.
Another interesting issue will soon arise as really effective therapy for HIV+ status (even before "true" AIDS develops), with definite impact on survival, morbidity, and (potentially) overall health-care cost, starts to become available (we are almost there already). One could argue (quite credibly, in my opinion), that from a medical point of view, and under those circumstances, HIV screening would be no different than breast cancer screening, cholesterol screening, etc., etc. However, such scenario does not really preclude obtaining consent prior to testing. One would have a much better argument to strongly recommend it for the appropriate individuals, to be sure, but patient consent easily could (should?) still be obtained prior to testing.
David Crippen:
Here is a real life scenario for you. I am stretching my memory but I think the facts of the care are adequately correct.
Several years ago I got a panic call from the ED that some young fellow had wandered in complaining of nausea or some usual ED complaint and turned out to be in liver failure. Coags all off the wall, yellow, bilateral pulmonic infiltrates, a bunch of other stuff. He was promptly hustled to the ICU where he promptly sat bolt upright in bed, crossed his eyes and his toes and barfed up UNBELIEVEABLE quantities of bright red blood, followed shortly thereafter by equal quantities from his rectum, all his peripheral IV sites, his nose and every pore in his body. While running around the bed trying to get meaningful venous access I inadvertently harpooned myself with a needle. Like the surgeons say, it isn't a matter of "if", it's a matter of "when".
His parents paced in the waiting room. No, they didn't know about any significant diseases; this was a surprise to them. About this time his live-in male friend arrived in tears and threw himself on the bed weeping, sliming himself with massive quantities of fresh blood....a scene straight out of Apocalypse Now. At this point I developed a sharply clinical interest in this guy's infectious disease status (Sorry for the Stereotype, Mike D ;-).
The patient quickly died squirting blood from every macro and microscopic orifice. After I broke the news I told the family that there was a needle stick involved and I needed permission to test for HIV. They waffled. "Our son couldn't possibly have AIDS, I don't see the need to test"...and so on, all while eyeing the sobbing male friend suspiciously. As it turned out I did get consent..and the patient did NOT have HIV. The end path result came back Hep B, and I have been vaccinated and I keep my titer up every few years. That was at least four years ago and I'm still pink.
Lets say for argument that the patient was never competent to give consent and the family did NOT give consent after the fact. Here is a high risk situation. What are my options?
Mike Darwin:
No need to apologize to me. I can stereotype as well as the next guy. If Id'd just stuck myself with a needle from an apparent victim of the Red Death I'd be wanting some answers too. ( Incidentally, the reason people can stereotype so well is that it is GOOD for their survival. (Besides, I don't count most gays are teary-eyed liberal democrats anyway and I can't stand them)).
But, you raise some other questions, here are my answers:
First, to the implied question about the right of healthcare workers to know the infectious disease status of those they treat: I think there is absolutely nothing wrong with every hospital or MD's office that wants to having a sign saying: "We are going to test you for communicable disease including HIV. Period." Don't give me the line about using Universal Precautions all the time. HIV infected people in WR 5 and 6 stages of the diseases frequently (especially in LA) have TB co-infection which is undetectable due to skin anergy. They present a hazard *beyond* the blood borne hazard. Further, HIV infection should be a warning that other communicable diseases should be present *and* it shouldmbe a critical part of the information any physician needs in order to give good care to the PATIENT.
Furthermore, there is now prophylaxis for HIV exposure: AZT+d4T+indinavir (for needle stick). However, these drugs are NOT cheap and they not something you want to take on a chronic basis. Thus, if you do NOT know the patient's HIV status you have no way to intervene.
For human cryopreservation patients we test as part of the protocol. If you become terminal and we are to be involved in your care we test for HIV, HCV, HBV and several other etiologic agents. This is how I picked up Tim Leary's HCV seropositive status and was able to caution his physicians and household members to use Universal Precautions instead of proceeding as they were to share smokes, handle open wounds (which he was covered with) and share eating utensils with him. Discovery of his HCV positive status also allowed his treating physicians to arrive at a more definitive diagnosis for some of his health problems.
Once a patient is legally dead we test for what we damn well please as we have a global consent and the patient's legal right to privacy is gone. We work under field conditions doing bypass emergently with mobile equipment. There is no way I'd expose my staff to that risk without their knowing what they were getting into: and we use battery powered HEPA filtration units, Tyvek suits and cut-resistant gloves! Pity you poor guys in the ED and OR!
To your other questions:
1) None...my wife moves out of the house during my quarantine period and I sweat it out? Your quarantine period can be comparatively brief if you have a polymerase chain reaction (PCR) test done for HIV nucleic acids. If you are infected you will start making HIV very quickly. Your quarantine period with PCR should be no more than 1 month at most. This will cost you about $300 US.
In the meantime (and after every exposure to blood or body fluid) you should use a condom with your wife. In fact, given your profession, I would put you in the moderate risk catergory and my lover, who does HIV counseling as a trained volunteer, would counsel you to use a condom all the time as a matter of course given your ED exposure (ditto a surgeon).
Furthermore, if you are engaging in extramartial sex or your wife is (this is a pro forma remark) you should be concerned about the e-variant of HIV which is currently cutting a swath through Thailand. HIV-e now accounts for 2/3rds of all infections in Thailand, has reached Bangkok , and is easily transmitted through normal heterosexual contact from women to men. A number of heterosexual US servicemen are already infected with HIV-e and it is only a matter of time before it reaches the "nice" girls and "nice" boys here in the US.
2) I draw a tube of blood secretively and have it tested by a private lab at my own expense? At your own expense? Well, if you want to have a PCR done, yes. If you want to sweat it out for awhile you can look in your Yellow Pages or call up any gay service organization and find out where an anonymous testing center is (I generally do NOT recommend the City or County Health Department: many (but not all) grody people, long waits, nosy questions, and people who might know you). Go get tested at 1 month (well over half of people who get infected with HIV seroconvert in the first 30 days) and at 3 months. You will find the place clean, extremely well run and staffed with sensitive caring people who will offer you a shoulder to cry on (barf!). And its free. AND it is anonymous. In the meantime use a condom. That probably means using a condom maybe what, once in three months? With your wife, I mean ;-). No big deal. (Hell I used one for 3 bloody YEARS -- after two YEARS of celibacy before the antibody test was developed and before we knew the incubation time!).
3) Go to court and sue someone (the American Way)? If it would change the ridiculous laws which have been enacted by militant queers (their word, not mine) that prevent healthcare workers from protecting themselves and their patients, and you have lots of time and money to burn AND you don't mind death threats or hate mail, sure!
I am sensitive to the plight of people who want to be treated as human beings and who want their medical confidentiality respected. I have seen some really hideous discrimination against HIV infected people including the leaving the food trays on the floor in front of the door routine: everybody I knew before1979 is dead. I've seen it all. But I strongly feel that ID testing is a necessary part of good medicine. And it should be balanced by a responsibility for medical confidentiality. The penalties for disclosure of HIV status or other medical information should be horrible -- as they are here in California($10K fine).
Sam Blackman:
My one (so far) needlestick experience was made a lot easier by the fact that the hospital I was working at, at the time, had a procedure by which HIV/HepB testing of the patient was done w/o the need for either written or verbal consent. All that was required was a tube of blood, which was assigned an identification number which was not connected to the patient in any way, shape or form. The results of the tests were _not_ placed in the patient's chart. I got the results back about a week later, via a phone call, from the hospital's "safety office". Of course, this doesn't preclude the possiblity that the patient may have been recently infected and not seroconverted yet. As an aside, my then fiancee was quite upset with the whole ordeal, especially the 1 week quarrantine period. Have others suffered the same emotional reaction from their significant others?
One other question -- when the gentleman who's blood I innoculated myself with found out that I had been stuck (thanks to a not so tactful nurse), he was profusely apologetic and assured me of his monogamy, etc. Has anyone else dealt with being stuck and having the "donor" know about the accident? What kind of reactions did you get?
David Ryon:
As another ex-warrior from the inner-city battlegrounds of HIV (having served in Bellevue Hospital in the late 80s) I take exception to Mike Darwin's high brow approach to HIV testing when another person's life (needlestick victim, rape victim) is at stake. As one who has endured self restriction and punishment that even a priest would envy, I would have thought Mike would be more sympathetic. While there is very little that can be done (AZT+d4T+indinavir has not suffered clinical trials in this setting on any large scale basis that I am aware of), there is genuine, avoidable suffering that occurs while waiting for the conversion to occur or not occur. Suffering that could be mitigated by knowing that the HIV status of the donor blood was negative.
In Dr. Crippen's scenario I would choose certainly choose: 2) I draw a tube of blood secretively and have it tested by a private lab at my own expense.
Such seemingly underhanded solution is ethically justified when you consider the very real threat of having to undergo empiric preventive chemotherapy (many needlesticks occur in interns/residents/nurses of childbearing age) unneccessarily, as well as real anticipatory suffering that could be avoided. The patient's heathcare record, insurance, etc is all protected so long as the a priori decision is maintained that the results will be kept confidential to the one who has secretly tested the blood. True, there will have been a real violation of what the patient/family expects from the health care system; however, the patient/family have also violated a basic human compassion for their fellow man who has suffered this injury while attempted to care for them. One must weigh the theoretical arguement: that occult testing such as this would lead to an undermining of trust in heathcare and a slippery slope of other occult activity without a patient's informed consent, against the very real situation of a needlestick victim who must now turn their life upside down.
Mike Darwin:
Wow, I must be really losing it. Maybe its because I'm so damn tired lately. Anyway, I mistook Crippen's question #2 to mean that he wanted to get his OWN blood secretly drawn and tested so he isn't treated like a pariah by his colleagues and barred from doing invasive procedures. David Ryon's post clarifies that what was being proposed was to draw the PATIENT'S blood without consent. OK, now I'm with the program.
Yes, I do have a problem with this. But I would still say "go for it." I definitely think the proper route is to change the system. But, far be it from me to tell an individual sweating the worry of HIV infection to say s/he can't bend the rules.
I've suffered unimagineable hours of worry over my HIV status before testing was available. When there were only ca. 150 cases we dialyzed a patient at St. Francis Medical Center in Lynwood who had GRID (then what HIV was called) secondary to amphotericin nephrotoxicity. It was a HORRIBLE death and especially terrifying to me since I knew by that time from doing log paper plots or MMWR case reports that it was infectious -- not poppers or bad street drugs! I had also spoken to Joel Weisman (the DO co-author on Gottleib's paper in NEMJ) and knew the incubation time had to be at least a year. I figured I was dead meat and that was my future in front of me on the Cobe Sentry II.
Well, I'd still say I've got a pretty good chance of dying of HIV. But having been through two needle sticks with seropostive blood from DEAD HIV patients (who have the HIGHEST viral titers) I can tell you that for me and most people, the terror subsides with time. You can't do HIV care or critical care without coming to some sort of peace about the possibility of getting infected -- or you leave. The acute care HIV nurses at the hospitals here tell me the same thing. I've made my peace with it.
As to my recommendations that high risk peope use a condom -- heh, that's what the recommendations are. I hate the damn things. But, if you are a surgeon or ED doc who is constantly exposed to blood you have to decide whether you'll even KNOW you are infected. And please, don't rely on the CDC numbers here to asess your risks. I *personally* know of two people (one surgeon one ICU nurse) who seroconverted from workplace exposure. Thy haven't told anybody but me and one or two very close friends (in one case only their wife and me). Why? Because they want to live normal lives and go on practicing medicine. The ethics here? God, I don't know. I've seen so much horror and stupidity with this disease I haven't a clue. I'm just numb.
Dick Burrows:
This is a different issue FL and does/should NOT require consent. You are not looking to do research - you are looking for real clinical information which may affect your life and the lives of your family. It cannot be unreasonable for health care workers to know whether or not they are likely to have been infected if something unfortunate has happened such as a needle stick injury. The issue is one requiring sensitivity & confidentiality in respect of your dealings with the patients parent's. I'm not certain they even need to know but then who does need to know - some of his boyfriends perhaps? These are social issues - not research issues.