The SUPPORT Study and the Standard of Care
Research
Lois Shepherd, 05/17/2013

The SUPPORT Study and the Standard of Care

(Research) Permanent link

The clinical research community and a number of prominent bioethicists have swiftly come to the defense of investigators conducting the SUPPORT study, in which approximately 1,300 premature infants were randomly assigned to be maintained at higher or lower levels of oxygen saturation. The study took place between 2005 and 2009, involved 22 sites and was reviewed by at least as many institutional review boards. In March, the Office of Human Research Protection (OHRP) concluded that investigators had violated the informed consent provisions of the federal regulations governing research by failing to inform parents of infants enrolled in the study about risks of retinopathy, neurological injury, and death. Results from the study revealed that infants assigned to receive the lower range of oxygen suffered higher rates of death than infants assigned to the upper range, while the latter suffered higher rates of retinopathy than the former.  Defenders accuse OHRP of faulting the investigators for failing to inform parents of risks they learned about only through the study. 

The central point of disagreement between defenders and critics of the study appears to be whether participants in the study were receiving medical care that was different from the care they would have received outside the study and whether participation in research therefore carried any medical risks that required risk/benefit scrutiny by IRBs or disclosure to parents of the infants enrolled.  This would appear to be a factual matter about which one could obtain some clarity, but discussions of this issue have been somewhat opaque. 

Part of the reason for this may be different, but unacknowledged, understandings of the concept of “standard of care,” a term used – both in the informed consent forms and the commentary about them – but rarely defined in this debate. 

Defenders of the study, as well as the investigators themselves, insist that because the lower (85 percent to 89 percent) and higher (91 percent to 95 percent) ranges of oxygen saturation provided to the infants were within the standard of care, understood as a range of 85 percent to 95 percent, there were no known risks to participants in the study.  David Magnus and Art Caplan write, “Given that there was variation in clinical practice [within the guideline-specified range of 85 percent to 95 percent] at the time the study was mounted, it is not clear how randomization among treatment options could have created novel risk over random physician preference.”  John Lantos writes, “Every baby in the study received treatment that could have and perhaps would have been given to babies who were not enrolled in the trial.”  The understanding of “standard of care” used by these commentators seems to lean toward the legal concept of that name.  In an ordinary malpractice case, physicians will be liable only if they fail to provide minimally competent care, care outside the range of what reasonable physicians would provide.  Appropriately, the legal standard of care is broad and often allows for many different approaches. 

Critics of the study – namely OHRP and Public Citizen – use a different understanding of standard of care. They are focused on either what physicians, or in this case, institutions, typically do or what a particular physician or institution typically does, not the range of what physicians can or might do without risking legal liability or criticism from their peers. OHRP’s determination letter relating to the study indicates that, at the time the study was initiated, participating institutions allowed oxygen saturation levels to range between 85 percent and 95 percent, rather than confining levels to either the lower or upper portion of that range. This led OHRP to conclude that the level of oxygen received by infants in the study “was different from what they would have received had they not participated in the study.”  Some received more oxygen than they otherwise would have, thus facing a greater, and foreseeable, risk of blindness, while others received less oxygen than they otherwise would have, thus facing a greater, and foreseeable, risk of brain injury and death.  A recent analysis by Public Citizen also focuses on what the usual practice was and, based on newly released documents, reports that the SUPPORT protocol itself stated that the higher oxygen-saturation range was “more conventional.”  In addition, two of the informed consent forms (the only ones that include this information) suggest that usual practices tended toward a target range of 88 percent to 92 or 94 percent.   

This is the crux of the problem.  Which of these two understandings is most appropriate for evaluating and disclosing risk of harm in a research context?  Whether the care provided will be within the bounds of acceptable practice or whether it will be the same as what the patient would receive outside of research?  

Defenders of the study have expressed outrage over OHRP’s action. Lantos criticizes OHRP (and Public Citizen) of endorsing “an anti-intellectual, unscientific approach to medical innovation” and concludes that “the real risk to babies come from reckless and ill-informed opinion about highly ethical scientific studies.”  In a more recent essay, he accuses OHRP of wanting doctors to stop doing research and to rely instead on “mystical certainties.”  Magnus and Caplan are more restrained. They charge that OHRP’s action “poses substantial risk” to the conduct of valuable research.   

 But it is not out of bounds for a research oversight system responsible for protecting subjects to ask – similar to the informed consent standards for medical treatment – “What do reasonable people who are considering enrollment in a study want to know?”  If this is the question asked, most likely the answer would be that they would want to know what reasonably prudent physicians typically, or usually, or conventionally do in situations similar to that of their child’s.  Given such information, they would better understand that enrolling in research means allowing physicians to do something different from the medical care they would normally receive, with potential attendant risks and benefits. 

Defenders of the study suggest that because physicians didn’t know the optimal level of oxygen saturation, any particular infant’s physician, or NICU, could have reasonably chosen to hover within the lower or upper range. But did they?  And if they didn’t, why not? These are questions to which the parents in the SUPPORT study had a right to answers.  Because they were told that their children would receive standard of care, they couldn’t know to ask them. 

Lois Shepherd, J.D., is the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics, Professor of Public Health Sciences, and Professor of Law at the University of Virginia.

 

Posted by Susan Gilbert at 05/17/2013 10:02:56 AM | 


Thanks to Lois Shepherd for pointing out the ambiguity of the phrase, "standard of care." The consent forms in the SUPPORT study had two main flaws. The first was the inclusion of a statement of potential benefit to the infants participating in the study but no corresponding statement of risks from randomization into two arms of the study providing different oxygen levels. The second glaring omission was any information, in almost all of the consent forms from the institutions involved, of what routine care would be if the infants were not enrolled in the study. A cardinal rule for consent forms is that they must identify the procedures of the research and distinguish the research maneuvers from what subjects would receive by way of routine care. The consent forms in the SUPPORT study were thus doubly flawed.

Ruth Macklin
Albert Einstein College of Medicine
Posted by: macklinruth@gmail.com ( Email | Visit ) at 5/17/2013 3:40 PM


Thanks, Prof. Shepard, for those thoughts.

Here’s what I still wonder, though. The investigators for the SUPPORT trial and for all the similar trials that were conducted simultaneously in the UK, Canada, Australia and NZ are all experienced neonatologists and leaders of the field. They probably understand better than the rest of us do what care is or is not generally given to babies in the NICU. They all that that the care given to babies in the study was not different from “conventional” or “standard” treatment.

For example, the NZ consent form said, “The aim of this study is to determine, within the range of oxygen saturation values currently used in the treatment of premature babies (85-95%), whether targeting at the lower end of this range (85-89%) compared to the upper end of this range (91-95%) is safe and effective…” (emphasis in the original)

The Australia consent form said, “Doctors and nurses worldwide try to give premature babies enough oxygen to keep blood oxygen saturation between 85% and 95%. We now need to find out if the upper or lower part of this range is better. Too much or too little oxygen for long periods may harm babies’ eyes, lungs and brain, in or out of the study.”

Neither of these consent forms, nor the US consent form suggested that the babies in the study protocol would be treated differently in any relevant way from babies not in the study. They did not see the treatment in the study as a deviation from the standard of care, or of standard care, or of conventional treatment.

As an analogy, imagine that doctors who treat children with antibiotics for ear infections give an antibiotic dose of 20-30 mg per kg. Imagine, too, that the amount that any child gets on any given day depends on which doctor they see. Some doctors prescribe higher amounts, some lower, in a way that, on average, leads to half the babies getting 20-25 mg/kg and half the children getting 25-30 mg. Imagine further that, when you ask the doctors why they prescribe certain amounts, they say things like, “It is the way I’ve always done it.” Or “It is the way I was taught.” Or “I don’t know.”

Imagine, now, that somebody proposes a study to see whether outcomes are better if children get 22.5mg versus 27.5 mg/kg. And that half of the babies in the study will get the lower dose and half the higher dose. Are the babies in the study getting treatment that is different from conventional treatment? Or are they getting the same treatment? And would it be adequate, in the consent form, to say, “Your baby will be treated with a dose of antibiotics that is currently used in treating babies with ear infections.”

I think that much of the criticism of the study is based on a belief that doctors know more than they do, and that standard practice is more standard than it is. By contrast, I think that the doctors who designed the study were aware of how little they knew, aware of how arbitrary and irrational standard practices were. In disclosing that to parents, they weren’t hiding the truth. They were telling the truth, disturbing as it may be. They sought only to find some evidence-based reason to eliminate some of that arbitrariness and irrationality.
Posted by: jlantos@cmh.edu ( Email ) at 5/22/2013 4:26 PM


Dear Dr. Lantos,

I am not persuaded by the argument that we should defer to the investigators of the SUPPORT study on the adequacy of the consent form (a research ethics question) simply because they are leaders in the field of neonatology. You point to the Australian and NZ consent forms as proof of what the standard of care was, but those forms, like the forms used in the U.S., only tell us what the investigators told the parents of infants in the study; they do not tell us what was actually standard practice at the time of the study. That is the key question. It is a question of fact, which can be empirically determined, and should be. Indeed, the answer should have been known before the study was begun, although it is not clear that it was. Your hypothetical antibiotics study assumes at least two critical facts that make it a poor analogy to the SUPPORT study: first, that the prescribing practices of doctors before the study were known, and second, that half the babies received the lower dosage and half the higher. Given what information is currently available about the SUPPORT study, it is unlikely that half the premature infants who would have met eligibility criteria for the study were cared for by targeting the lower oxygen-saturation range and half the higher.

Sincerely,

Lois Shepherd
Posted by: lls4b@virginia.edu ( Email ) at 5/28/2013 12:05 PM


I don't believe that Dr Lantos stated that we should 'defer to the investigators on the adequacy of the consent forms'. He suggested that experienced academic neonatologists had a good idea what was standard practice in terms of saturation limits.
I also do not understand why you hypothesize that the premature infants who would have been eligible were not being treated within the saturation limits tested in these studies. In fact, the understanding of what was standard practice prior to SUPPORT and the other trials was indeed based on empirical data.
You suggest that the investigators were recklessly endangering infants by using saturation limits that were outside of standard practice, and that they were intentionally misleading parents in saying otherwise. I think these are grave accusations.
Your question of fact is very easily answered by a few minutes searching PubMed. This reveals a large number of publications about oxygen saturating targeting prior to SUPPORT, including surveys designed specifically to investigate what were the target levels of oxygen saturation then in use. One for example surveyed 144 tertiary NICUs in the USA, and found minimum SpO2 limits that were between 82 and 96, and maximum target limits that were between 92 and 100. (Anderson C et al J Perinatol 2004;24:164). So the target limits in SUPPORT were indeed well within standard of care at the time.
The antibiotic analogy does not require that exactly half of the babies were being treated in the respective dose ranges. It requires that there is uncertainty about the dose to be used, that reasonable physicians were already using doses in either range (or indeed using doses in the middle of the range, or outside of it), and that there was no prior reliable data that one was better than the other. It requires that it is not just one rogue doctor giving the higher dose, but a realization that the best dose is unknown.
So yes, the target ranges were within standard of care, and yes, that was actually known.
In the antibiotics analogy, why would you actually do a trial? One could presume that the concern of the investigators would be that the higher dose might have more side effects (but the dose might actually still be safe, so this is unknown before the trial), and the lower dose might have more treatment failures (but the dose might still be adequate, so this is unknown before the trial). Would it then be ethical to do a trial? Would it be ethical to state on the consent form that current doses are uncertain, and both of the doses being tested in the trial are within current ‘standard of care’? I submit that the answers to both questions is ‘yes’. I submit that the antibiotic trial does not, therefore, increase risks to the participants, and that a consent form which stated that would be appropriate. If that consent form explained why you wanted to do the trial, including the fact that the investigators were going to measure treatment failures and side-effects, then I submit that parents would have been adequately informed, and have enough unbiased information to make a choice for their children.
Dr Macklin and you seem to be suggesting that the consent form should also say ‘if you refuse the study then your baby might get the high dose, or might get the low dose, or some other dose which might be higher or lower or in between, but will be chosen by the prejudices of the physician or the protocol of the clinic where you are being seen’. That is indeed analogous to what we would have had to put in the SUPPORT consent forms, I don’t see how that improves the acceptability of the consent form compared to saying, as it did, that the baby would receive the 'routine care given in the delivery room or nursery'.
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I would to add to my opinion to the previous comment: I am not persuaded by the argument that we should defer to the investigators of the SUPPORT study on the adequacy of the consent form.
I think that much of the criticism of the study is based on a belief that doctors know more than they do, and that standard practice is more standard than it is.
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