Observational data – far from worthless

I’ve been following a discussion about CIO (crying it out) pros and cons over at iVillage that I found via a trackback to my blog stats. A poster had requested scientific information about the Ferber method/CIO in general. Someone (Thanks! 🙂 ) had posted some of my critiques of the usual garbage that gets passed around the Web as “scientific information abut CIO”, but is nothing of the sort. Of course, one of the other anti-CIO posters (who herself had posted two sources full of said garbage information) was not going to let those links stand. Having skimmed them, she pronounced the studies I referenced to be about “whether CIO works, not whether CIO is safe” (which is patently untrue – see the link referenced here). When her error was pointed out, she still insists we do not know the “dose” of CIO which is sufficient to cause brain damage (as demonstrated by studies which deal with prolonged separations and outright abuse in animals and children) and “If CIO were a drug, there would be clinical studies done to determine the physical effects and potential risks, at what dosage level it causes harm (overdose), and other factors relating to it’s safety before it could be approved for doctors to prescribe it or parents to use it. ” More to the point, she pooh-poohs the idea that parents’ and other observational data could actually be meaningful:

The studies presented are based on parental observation and little else. No medical studies on how an infant’s BRAIN actually responds to CIO have ever been presented. In other words, there is no “evidence of no harm”…. and a great deal of information that points to the possibility of harm. Is there definitive evidence on either side? Not at the moment. Is there reason to doubt the safety of this method? I believe so.

I often come upon AP/NPers (attachment/natural parenting devotees) responding to stuff that I’ve written which is referenced online. Most of it is an embarrassing demonstration of their lack of reading comprehension (and indeed, it’s quite obvious this poster did not initially read the links provided), but this case refers to something slightly different which, I think, could use a bit of elaboration, as it reveals a bias and error of thought common in AP/NP philosophy.

As I have pointed out before, her “great deal of evidence that points to the possibility of harm” leans heavily on untested hypotheses, twisted study results and outright lies and omissions such as this and this. But is it really true that observational studies can’t tell us whether CIO at the “doses” normally used in the context of sleep training are harmful or not?

As I have pointed out before, it’s impossible to conclusively prove a negative. And people who object to a practice they don’t like will often use the precautionary principle in a selective manner, moving the goalposts constantly to keep their pet theory (in this case “CIO causes harm”) alive:

It’s also important to remember that many of those who invoke the precautionary principle do so not out of concern for the masses, but for political purposes. They also tend to invoke it selectively – e.g, PCB’s in baby bottles are ‘proof’ that bottles are bad, but PCB’s in breastmilk are, mysteriously, not a cause for concern. Thimerosal in vaccines, despite the Institute of Medicine’s statement rejecting a connection with autism, is OMG A TOXIN WE’RE INJECTING INTO WIDDLE BABIES!, but the unregulated, non-FDA supervised potion their herbalist gave them? Just fine.

I wonder what that APer would think about the following scenario: A woman who is breastfeeding her newborn baby has an infectious disease which requires her to take penicillin, otherwise her health will deteriorate. Her doctor tells her that she must stop breastfeeding her child immediately, because the long-term effects of penicillin on a newborn baby have not been studied in controlled trials.

If she is like most APers I know, she’ll probably be falling all over herself to denounce this doctor as a moron, and that the woman in question had better get another doctor STAT (and I would even agree). However, the doc is technically correct: there really are no controlled studies which examine the safety of penicillin while nursing, or for that matter, pregnancy. The reason we (and Dr Hale) know that penicillin will cause the baby little to no harm if passed on via breastmilk is…wait for the drumroll…60+ years’ worth of observation.

You see, while observation is not really a good way to infer a positive cause-and-effect relationship, a very long period of observation is quite useful to come to a conclusion regarding the lack of a cause-and-effect relationship. Meaning that if a practice has been common for decades or centuries and side effect X has not been observed after its use, it’s quite reasonable to conclude that X is not a side effect of that practice, or else is a vanishingly rare one.

Hence, if many breastfeeding women have been taking penicillin since the 1940s and there have been no reported cases of severe infant adverse reactions as a result, it’s fairly safe to conclude that penicillin in breastmilk has no severe adverse effects, and allow its continued use in breastfeeding mothers.

Consider another observational project, this time regarding vaccine reactions: VAERS. This project serves as a portal for reporting adverse events which happened after administration of various vaccines. As VAERS has been around for several decades, if a certain adverse event is not listed as a purported result of a specific vaccination, it’s pretty safe to assume that that that particular adverse event is not a side effect of that vaccine, and there is no obvious reason to study it. For example, if nobody has ever reported that the DTaP vaccine caused their child to grow elephant ears, it’s fairly certain that DTaP probably does not cause this. (Mind you, that doesn’t mean that if a group of parents suddenly did report that their children developed elephant ears after DTaP, then DTaP would necessarily be the cause – just that it would have to be investigated).

What does all this have to do with CIO? Well, CIO in the context of sleep training has been around for a long while. Parents have been exhorted by various experts to let their babies cry themselves to sleep and during the day, and I might add in a much less controlled (i.e., higher “dosage”) manner than usually promoted today, for at least 80-90 years now. Despite this, one will be hard-pressed to find even one credible case of a child who was sleep-trained by CIO (Weissbluth, Ferber or otherwise), at the appropriate age and in the context of a loving, responsive parental relationship, who was harmed by the practice. For example, I suspect Dr. Sears’ recounting of the scary-sounding “Shutdown Syndrome” is highly embellished, but even there, he is talking about a young (4 months old) child whose parents changed several of their parenting practices all at once, including CIO. And I would think that the example in my previous post is one nobody wants to touch with a 10-foot pole…

So given the rather long period of observation – whole generations raised on this practice – and the lack of credible evidence of harm coming about solely by CIO in the “doses” used today (and even in higher “doses” as used in the past), it seems fairly reasonable to conclude that use of CIO in these “doses” does not even come close to resembling the crying and stress brought about by genuine child abuse and neglect (which has plenty of observable negative results), and is almost certainly safe. Something, mind, which cannot be said about certain forms of cosleeping in the early months…but that fact rarely penetrates the minds of the AP ideologues.

But what about the claim that we can’t know about the harmful effects of CIO because “No medical studies on how an infant’s BRAIN actually responds to CIO have ever been presented”, or because we don’t know how babies’ hormones react to the stress of CIO? Even then, we would need observable phenomena to check if the hypothesis that “CIO damages baby brains” is valid. Because how would we know if a certain hormonal pattern or a given pattern on the fMRI is associated with an adverse psychological outcome, if we don’t correlate the patterns we see to scores on psychological tests or other directly observable phenomena? A given level of cortisol or a lower-functioning area of the brain in an fMRI test is not, in and of itself, a pathology – it could also signal a healthy, adaptive response to a challenge. Never mind that even then, we would still have to prove that the pattern is caused by CIO and is causative of the psychological effects. In any case, I would submit that the current state of knowledge regarding stress hormones in particular is still very, very far away from enabling us to reach such conclusions (and will elaborate on that further in a future post), even if we had demonstrated a sustained difference in stress hormone levels and response in CIO’ed babies – which has not yet been done, to remind you.

But we can see that even when an attempt is made to assess the hormonal state of babies undergoing CIO, the anti-CIO mamas still get the vapors and run to sign petitions claiming such an experiment is unethical. In fact, one of the references the anti-CIO poster herself brought as evidence claims so. Mind you, I have no idea if the study itself is well-designed or will actually prove anything worthwhile. But the anti-CIO contingent is indulging in a circular argument here: We just know CIO is harmful even though it’s never been studied and there is no empirical evidence of such (and some empirical evidence to the contrary), therefore it’s unethical to do an experiment to test whether CIO is harmful or not.

One might even suspect the anti-CIO contingent is afraid of finding out the answer…

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64 Responses

  1. The objection to CIO from an ethics standpoint would be that you can tell that the baby in question is exhibiting signs of distress, namely crying, and that, presumably, actions could be taken to make it less distressed. You’d have to show that benefits *to the baby* (and not to the parents, regardless of how they have to get to work and such) outweighed harms.

    Sometimes torturing an amnesiac is acceptable — like when it saves her life. But just because whole generations of people have used high doses of CIO doesn’t mean that because our dose is lower, it’s necessarily okay just because they don’t seem to show evidence of harm *now*. It is sufficient to have evidence of harm *during CIO*. Like crying that stops when you pick them up.

    • How is the baby’s crying “evidence of harm during CIO”? Evidence of the baby’s displeasure, certainly. But by that logic, is saying “no” to a toddler’s wish for candy which causes him to burst into tears similarly “evidence of harm”? The toddler would, in fact, stop crying if you gave him the candy.

      And given that there is plenty of research which demonstrates the harms – to parents and babies – of not getting sufficient sleep, it seems the ethics are taken care of…which is why certain anti-CIO peeps (like Doc Sears) had to invent the “evidence of harm” issue.

      But this post isn’t only about CIO, really. It’s about an error of thought that could be applied to just about any subject – that you always need double-blinded RCTs to come to a reasonable conclusion about a given issue, and that until we have the results of such trials, we should invoke the precautionary principle.On the surface, it sounds so scientific, so reasonable and logical. But as demonstrated, this is the wrong way to think about things, and if applied to another issue these people favor (BF and medicines), all of a sudden it doesn’t seem so reasonable…because observational data over several decades does in fact, count for something.

  2. Brain Damage? That is a new one to me.

  3. Caryn,

    Did it never occur to you that crying might be a harmless way for the baby to release stress and tension? Is it a forgone conclusion that crying is a bad thing? The only way to know is to know the baby. Who is in a better position to know that baby than its parents?

    Of course parents are less apt to trust their instincts when they’re being told that allowing their child to cry causes brain damage or just plain old harm (Esther and others have dealt with that question very well on a number of occasions) or this not so subtly implied suggestion that parents needs to get to work, to get some sleep don’t matter.

    What’s ethical about that? It is so insane to suggest that both parents and children’s needs matter and that working these things out should be left to them?

    I’m sorry if I sound frustrated but I am. I’m so tired of watching parents beat themselves and each other up about this issue and the one-sided negative view of parents’ capasity to know their babies’ needs and the assumption that they are so apt to harm their children in the course of the normal ups and downs of family life. Can we not just extend the benefit of the doubt now and then?

  4. I’m not arguing that CIO is harmful. I’m talking *solely* about how one would get a study past an IRB. 🙂

    • If making babies cry couldn’t get you past an IRB, then no studies involving injected medicines (e.g., vaccines) could ever be done.

      Interestingly enough, that particular iVillage board also has a couple of very successful CIO stories on it right now (where babies learned how to sleep thru the night in 1-2 nights). It’s a little hard to argue that this constitutes torture…

  5. To make that more clear — I have out of town visitors, and am scattered this week — the ethics individuals work out on their own within their family are one thing. The ethics of running a funded study are quite another.

    Babies cannot consent to be in a study where we test how displeased they are.

    And I’m in agreement with you that we *can’t* always run a study, hence the comments I was making about the 100% hospitalization policy on HBD.

  6. Esther, you know perfectly well that what you have to have is evidence of a benefit *to the baby* greater than the harm caused *to the baby*. Hurdle easily jumped in the case of vaccines. Not so easily jumped on the grounds that we’d rather have them sleep on a schedule.

    • You mean the fact that my baby is getting more sleep and is in a better mood doesn’t fit the bill? And what evidence is there that there is *any* harm to the baby?

      Mind you, i’m not so sure that in the case of every new vaccine they try out, the benefit outweighs the harm in that baby. It would be hard to say until the experiment is over, usually.

      Morever, why can’t the benefit to the whole family count?

      (And I didn’t see your comments at HBD…going to look)

  7. We can’t assume crying is anything *but* an indication that the baby is unhappy, ’cause we can’t ask them.

    We can test vaccines because we have equipoise — the consensus in the scientific community is that any given individual is at least equally likely to be benefitted by being in the test arm as in the control arm. We can’t test things *unless* we have a reason to think that the *population as a whole* will benefit more than be harmed from the intervention in question. But getting more sleep and being in a better mood isn’t necessarily going to outweigh, for the whole population, the only report we can have from the subjects about their subjective experience of the intervention, particularly since it isn’t going to, you know, keep them from dying the way a vaccine is.

    How are babies to withdraw their consent during the trial? And why is it okay for the people who are getting the benefit — namely more sleep — to exercise their right to give consent for this trial without a conflict of interest? Sure, the parents can say it’s okay to let the babies cry, but the parents are the ones with the obvious benefit here.

    And we can’t count benefits to the whole family because of political liberalism. Children are individuals with rights.

  8. Sorry, that should be “And why is it okay for the people who are gettingthe benefit — namely more sleep — to exercise their right to give consent for their children to be in this trial given that they have a conflict of interest?”

  9. It think you’re absolutely wrong to try to abstract the interests of children from the interest of their parents at this stage. You seem to be assuming that the interests of parents are fundamentally opposed.

    But the thing that bothers me most about all of this is I can’t for the life of me see why anyone should be interested in studying this. Where is the problem that merits this investigation of the crying it out. Is there some sort of terrible change in the welfare of children at the level of the general population demanding an explanation? I’d like to see the evidence for that if it exists.

    Right now it just seems like pathologizing normal parts of raising children.

  10. Ethics committies *have* to abstract those interests. Individual families do not.

    Scientists are interested in studying all sorts of stuff, and they don’t need a *problem* to do it — they can just find the topic interesting.

  11. I’m the first to agree with the principle of knowledge for it’s own sake. But I don’t for a moment believe that this line of research has anything to do with a quest for knowledge. This is a raging debate and I think it’s just a bit disingenuous to claim it’s simply an interesting topic.

    Honestly, it smacks of advocacy. It seems to me to be an attempt to use science to shore up a particular prejudice and lend it legitimacy.

    With most issues of child welfare or health – and, correct me if I’m wrong, but this seems to be what this is about – the impetus for study comes from some identifiable phenomenon. This seems the inversion. Study that sets out to validate a particular theory about the effects of crying. That’s not science, at least not as I understand it.

    And as it happens, I think that assuming that parents and children have different interests actually prejudices the results from the start.

    • There is nothing unethical (vis-a-vis an IRB or in practice) about making babied unhappy – you’re not allowed to cause them physical pain or torture. And just because the baby isn’t aware that she will ultimately benefit from it, doesn’t mean that a practice isn’t in her (and her parents’ , for that matter) best interests. And what evidence do we have that CIO causes harm? Unhappiness isn’t harm.

    • Nancy:”With most issues of child welfare or health – and, correct me if I’m wrong, but this seems to be what this is about – the impetus for study comes from some identifiable phenomenon. This seems the inversion. Study that sets out to validate a particular theory about the effects of crying.”

      More correctly, it’s taking a practice certain people don’t personally like (which is certainly legit) and attempting to make it wrong for everyone, using science. Or in this case, misusing it.

  12. Psychological harm is harm, and causing unhappiness is causing psychological harm. (A local IRB recently kicked back a study into the dynamics Alzheimer’s patients and their caregivers on the grounds that the caregivers were inherently coerced in a way that prevented them from being able to give informed consent for the patients to participate in the experiment, which is what’s informing my comments here.)

    I’d be the last person to claim that any given parent *should* do anything in particular with her children based on outcomes from a study like this (as you know, Esther, and as you probably do not know, Nancy, unless you’ve been lurking about on HBD.) Individual children vary individually, and I don’t see that a study into CIO would tell us anything at all about what it is that benefits an individual child or an individual family, or what given individuals *should* do. People engage in activities that aren’t the safest or the wisest scientific choice routinely; parents have the right to make decisions for their children.

    Let me make clear that I also don’t see that claims about cosleeping as a way to prevent unspecified brain damage are in any way tenable or tell us anything about what benefits an individual child or an individual family.

    But I think the point that a study into CIO is necessarily unethical is probably valid, because researchers cannot accept as subjects babies whose informed consent has been coerced. Parents and their children are necessarily different people with different interests, and babies cannot give their own consent or withdraw themselves from the study if they find the conditions to be untenable. Adults can opt into a study for the sake of advancing scientific knowledge even in the case where they do not expect to gain personal benefit, because they can give informed consent without necessary coercion. But parents trying to justify claims — in either direction — about the “best” way to sleep with a baby are necessarily coerced and finding a population unaware of this debate would be, dare I say, impossible.

  13. I can’t say much about the IRB in the case of the Alzheimer’s patients because I don’t have enough info, but making a child unhappy in no way constitutes psychological harm. Otherwise you might want to call CPS on me right now, because there have been plenty of times when I’ve said “no” to my kids’ wishes for treats, and this made them cry. You probably couldn’t perform a Strange Situation test to check attachment style, either, because it makes most babies anxious when the parent leaves.

    And legally, parents as guardians have always given informed consent for children. I don’t see why it should be any different here, or why the parents’ and children’s interests are necessarily at odds.

    The petitioners use as their sources an AAIMH paper which admits outright they have no scientific resources to back up their concerns (see here). As I said, it’s such a circular argument: First they assume that CIO is harmful, then they want to ban research to see if it’s harmful because it’s harmful (though they don’t actually know this, because it’s never been studied and despite the fact that they can’t actually point to any empirical evidence in CIO’ed humans that demonstrates it’s harmful).

  14. Parents and medical researchers are operating under different sets of rules. Parents can make their children unhappy in ways that medical researchers cannot.

    I already discussed why the granting of consent for children would be considered inherently coerced in this case; the parents stand to benefit.

    The interests of parents and children are *always* their own. They may overlap at times, but ethically we consider them as separate individuals and as ends, not as means. Kant won that argument way back in the day.

    I have no doubt that there are no scientific resources to back up these claims; I had a discussion about this for about 10 minutes yesterday with my co-author, a philosopher who does medical ethics for the local IRB, and he and I couldn’t think of a way in which you could *get* scientific resources to back them up, because medical researchers couldn’t assume crying communicated anything other than physical or psychological distress, which they would then be ethically required to take actions to ameliorate. That’s been my whole point through this thread. Parents don’t necessarily have to make that assumption, particularly not if they have additional data about their children that leads them to think that it isn’t true. But medical researchers do not know the children in question.

    Apart from that, even if there *were* data, I’d be willing to bet that what they showed was that different children are different, and the people with the best information about the children in question — namely the parents — would be best-placed to make decisions about how children would sleep best, because parents *can* run these experiments without being shut down by an IRB.

    • Ah, but the researchers are not doing the CIO, the parents are. As similar studies (without hormone assays) have been done before, also in Australia in fact, it would seem that at least there, common sense prevails in ethics. Perhaps psych research utilizes different criteria?

      Here (.doc file) is the study protocol.

      And it doesn’t explain how using the Strange Situation test could possibly be ethical, if what you say is true.

      ETA: And looking at, for example, Duke University’s IRB guidelines (.pdf file), I see no reason this study wouldn’t pass the ethical test under either the first or second categories. There is also a provision by which parents’ consent can overrrule that of their children in certain circumstances.

  15. It’s one thing to say parents and children have distinct interests in the abstract. It’s another to try to tease apart these interests at the level of reality. For all intents and purposes it can not be done and it should not be done except in the most exceptional circumstances because it is likely to damage the parent-child relationship which is more than the sum of its parts.

    Should a mother have a c-section or not? Should a child breastfeed or not? These are not questions we can answered through research or even study because they are moral, personal decisions made in the context of a dynamic and intimate relationship.

    This is what makes research into these areas so problematic – difficult to design, of questionable value and likely to undermine parents position visa via their children and society at large.

    • The irony of it all is, of course, that if the anti-CIO contingent would just use their eyes and their common sense, it would be clear from the observational data gathered over the past many decades (plus the research that already has been done on humans) that no major harm is caused by CIO. But by raising a whole smokescreen of non sequiturs comparing the psychological results of the practice to those of outright abuse and neglect, it is they themselves who are, in effect, asking for this research to be done.

      (I might add that I’m not sure the study being undertaken in Australia will necessarily give conclusive answers either, though, because interpretation of cortisol levels is more complex than you’d think. It’s not as simple as cortisol elevation=stress).

  16. Thanks for the link, Esther. I’ll comment on what I notice about the study design.

    First, the population isn’t the population of all babies. It’s the population of babies who fall into the category of “sleep-disordered”, which means that they might see greater benefits than harms from interventions, right? My objection (see above) was to the ethics of a hypothetical study of set of all babies who weren’t sleeping on a schedule, not necessarily to the population who were diagnosable as sleep-disordered.

    Second, since parents can opt out if they decide they shouldn’t be doing CIO with their child (for whatever reason) then it’s entirely possible that this study is going to end up looking at the population of babies for whom CIO works, and not at the population of babies for whom CIO does not work, since those parents might well opt out of the trial.

    So this goes back to what I’ve been saying (and for that matter, what Nancy’s been saying), which is that even if such a study could be conducted ethically, it would be unlikely to provide us with much in the way of useful information. From this, we’ll get information about cortisol levels (which you note are complex to interpret) in the set of sleep-disordered babies who stayed in a trial of three different sorts of behavioral modification designed to benefit those babies.

    The Strange Situation test is designed so that if the babies exhibit signs of distress, the parents immediately returns to comfort them. A behavioral modification designed to allow babies to report distress without parental engagement is necessarily a different problem.

    I agree utterly that it’s the claims that CIO is harmful when done by parents (who presumably have perfectly good judgement) which have precipitated the attempts to study this more seriously. You’ll note that I am making no such claims. 🙂

    As for IRBs, I’m not a medical ethicist — that’s my co-author — but he seemed quite certain that human subjects research would require proposed benefits to the baby to outweigh harms to the baby, as I said above, because studies in a broad population of babies where the benefit is *to the parent*, i.e. having the baby sleep on a schedule convenient to the parent, fail, because babies have their own interests.

    And of course questions about what individuals *should* do cannot be answered by scientific study, because they are questions of ethics. This is generally why appeals to common sense fail, actually. Just because we’ve done X frequently before with no obvious harms doesn’t mean that we *should* continue to do X now.

    • Caryn, there would be little point in CIO’ing babies who don’t have sleep problems – though, as defined by the criteria at the top of the study, many if not most babies in the age group mentioned will be considered “sleep disordered”. It’s the parents who are making the diagnosis, as opposed to, say, a sleep clinic. And yes, it’s reasonable to consider the babies will benefit if they meet those criteria, but it’s not a matter of making a formal diagnosis of ‘sleep disorder’.

      Similarly, the parents are the ones who opt in or out – the self-selection is not according to the babies’ characteristics, but those of the parents. So chances are we’ll be looking at a baby population similar to the population undergoing CIO in “nature”. And this is fine and informative, because I agree entirely there are no “shoulds” to CIO and if the parents aren’t suited to it, they are perfectly entitled not to. I’m more concerned with the idea that parents *shouldn’t* use a helpful tool because of bogus allegations of harm. And it’s fairly safe to assume no severe damage is done by CIO, because we have several decades of observational evidence to work with.

      The cortisol measurements and patterns will be very problematic (and at the very least, there should be a psych assessment before and after as well to correlate the hormone levels to psychological state – maybe that’s what the questionnaires are about?).

      The Strange Situation involves ~3-minute stages, so the parent doesn’t immediately come back to comfort the baby. And as you point out, it’s done on babies who don’t directly benefit from the study and don’t have any obvious ‘disorder’, parent-diagnosed or otherwise. Presumably, parents are also entitled to stop the testing at any point in the SST. But I would guess that the SST would be even more ethically ‘iffy’ than the CIO intervention desribed above due to the lack of clear benefit to the babies.

      And yeah, I like WordPress, but preview would be nice… 🙂

  17. Bah! You have no preview button!

  18. Even though, this was a bit upthread I had to chime in on this:

    “And why is it okay for the people who are getting the benefit — namely more sleep — to exercise their right to give consent for this trial without a conflict of interest? Sure, the parents can say it’s okay to let the babies cry, but the parents are the ones with the obvious benefit here.”

    My child benefits greatly from my being well rested. I read an article somewhere that the effects of sleep deprivation are similar to those of hangover. As something of a reformed party girl, I have to say that this is the case for me. Reaction times are slower so not as safe to be in a car. The ability to think about a complex problem (like how the heck am I going to get from now til nap time given that is pouring buckets outside and we’ve already read stories, danced to music and done a craft project) is diminished. Perhaps some are even a little less patient, not me mind you, I am a paragon of parental graciousness, but someone not as disciplined as me might snap sooner at some more persistent behaviors of a tot (tongue squarely in cheek). And maybe not related to parenting, but worth mentioning because it annoys me, I feel very dehydrated when I have not had enough restorative sleep.

    I also don’t think that an over-tired child is such a great thing. Some people seem to really like a cranky, accident prone tot, but I just don’t. I don’t think it’s healthy (there’s a reason sleep deprivation is considered torture in a different context). So go on and do a study ethical or not, but include a discussion about why it’s so great to have a tired kid. Yeah, yeah, I’ve heard there are other ways, but honestly they all just seem to be modified versions of CIO. OK, so you’re in the room with tot for an hour-and-a-half, constantly reassuring tot that you’re there and it’s OK to go to sleep, how does anyone who does this know that they’re not just hindering the whole falling to sleep process and increasing the sleep debt?

  19. Caryn: How do you know the benefit *isn’t* likely to outweigh the harm in children? I know the CIO decision is often presented as interests of nasty selfish parents vs. interests of poor innocent tortured baby, but, in practice, the two interests are deeply intertwined – parents who are exhausted and at the end of their tether are potentially harmful for a baby. I don’t just mean the risk of them snapping and abusing the child, although that’s a factor, but the much more common, subtle, and ongoing problems caused by parents being constantly snappy and irritable and too tired to engage well with the child. Plus, as Willa said, there’s the effect of sleep deprivation on children. From my own rather unscientific observations of two children, I can tell you that they seem distressed and uncomfortable when they’re tired, and a whole lot happier when they’re well-rested. I don’t see how the ethical problems with this study are any different from those involved in trying a new medicine in children, and that’s something we consider acceptable and indeed necessary.

    Esther: Great post. But surely you’ve read the articles in which anti-CIO-ers blame CIO for the many ills in today’s society and claim that it’s as a result of it that so many people a) are so maladjusted and b) need to take sleeping tablets?

    I had another point about the flaws in the “but we don’t have proof of NO harm!” approach, but it’ll have to wait until I’ve got more time – got to get my kiddo up to head out to Gymbabes.

  20. Sarah V. – Maladjusted compared to whom? The people who were born in the 1920s onward who were widely CIO’ed, and managed to receive the title “the greatest generation”?

    I think we need to take those claims the same way we should take Jean Liedloff’s claims in The Continuum Concept, that because western babies are not “in arms”, our adults are addicts and homosexuals…with a huge eyeroll.

    Incidentally, I encountered an APer on a mommyboard several years ago who insisted her husband was a chronic insomniac as a result of his being CIO’ed. A couple of years later, after she left him along with her children, she admitted that chronic insomnia was the least of his problems. He also had been physically abused, and in fact, was in turn abusing her and the children (which is why she left).

  21. Well, as someone who brought up her children before mothering became a neurotic, high stress competition, I am a bit fascinated by the idea that a baby/toddler/child will suffer psychological harm if frustrated in any way. Is there a new kind of infant these days who DOESN’T cry? In my experience, infants cry when tired, when hungry, when cutting a tooth – and some seem to cry just for the hell of it. Most of the time, they can be comforted by being held – but not always. The cartoon image of mother/father pacing the floor wwith a howling infant isn’t exactly unusual, I don’t think. Is it only crying alone in a cot that counts? Are there people who have trouble distinguishing between a “normal” amount of crying and a child who is seriously frightened and distressed? Do I get cast into the outer darkness of terrible mothers, because I didn’t freak out over a crying infant? My children are now adults. My brain damaged daughter had “colic” – and a terrible start in life, so screamed blue murder for months – brain damaged children do – (It is an abnormal, high pitched cry, before anyone starts panicking) and now appears to be rather sunny natured all things considered. My other daughter never bothered to CIO, being rather keen on going to sleep – she finds adult life a bit more of a trial, and no doubt I got it wrong numerous times throughout their childhood – I put it down to being a bit on the over-indulgent side, myself.

    And how about these co-sleepers? Do they all sleep like – ermm – babies? No snoring, thrashing about, talking in their sleep, getting up for a drink of water?

    I can understand the agonising over BF, vaccination. Psychological trauma from crying has me completely bemused.

  22. As I keep saying,

    1) It has to directly benefit *the child*, not the parents, to pass the benefits/harms test. Babies are ends, not means; we cannot do things to them because those things will benefit the parents which will then allow the parents to help the children, at least partly because there’s no reason to think the entire benefit will go to the child, and if it doesn’t, that’s treating the child as a means.

    2) I’m not suggesting that frustrating a child in any way will cause psychological harm. I am suggesting that a researcher *cannot* assume crying is anything other than a sign of distress, which is psychological harm, precisely because the researcher is in a different position from a parent in this regard.

    One of the more interesting things about talking about philosophy, of any stripe, in public is how long it takes for people to be able to read what it is that you said, instead of what it is that they *think* that you said. I see no difference between the things I’ve said on this thread, and the Duke IRB document. 🙂

  23. Also, on the topic of what it is that counts as “sleep-disordered” — it’s my understanding that this is a formal diagnosis even in babies, for babies more than a sigma off the mean. If the parents are the ones making the diagnosis, then we have an even clearer conflict of interest, and this would not make it past my local IRB. For the same reason as the one I gave above, which is that it’s not necessarily the case that it benefits the babies to sleep *on our schedule*.

  24. And finally, because I’ve made this point before on HBD but not here (sorry!), it’s not necessarily the case that it’s only the parents who can be poorly suited to CIO. Some babies scream for hours instead of falling asleep and never really learn to go to sleep on their own until they’re older. My DH screamed every night from 8 pm to 11 pm, while rocking his head back and forth into the headboard, for *three years*. A heavy CIO dose didn’t work, for him, and a parent with the ability to opt out of a trial assessing that most likely would do so now.

    In fact, I wonder if there are guidelines in the behavioral therapy for how to tell that the particular tactics aren’t working for that particular baby. Say behavioral approach number one is to put the baby down in the crib and talk to it and pat it to calm it, staying in the room until it stops crying before leaving the room for three minutes. Let’s also say we’ve got a hypothetical baby who, when placed in the crib, starts screaming, does not calm down, and vomits after five minutes. How many times does the parent run this test — and how many times is it ethical for the parent to run this test — before concluding that this baby needs to use some other tactic? The researchers probably have a cutline in the approaches to move babies from one therapy to another. Some children will be unsuited to all of the therapies in the trial, and I note that the study design says that parents who withdraw will be provided with additional help (with their data pulled from the dataset.)

  25. Wonderingwila, thanks for reminding us of the benefits of having a well-rested child and being a better-rested parent.

    Just last night, after being awoken for the 4th time by various children, I decided to let my toddler whine for a bit rather than go to him. Yep. I just turned off the monitor. I believe it was in his best interest not to have an over-tired, frustrated mom fully wake him up to rock him after she had been up with her other kids have the night. While I realize this was not traditional CIO, 2 minutes of whining would have become 20 minutes of rocking.

    RedOne

  26. ITA with Wonderingwila and RedOne…how come the benefits of a well rested parent and child are always ignored. I have a cousin (totally anecdotal here, so no I am not making any hard and fast claims) who could not bear to CIO with their first child…years of therapy, misdiagnoses for ADD, ADHD, sensitivity disorders…anyhow in the end it was SEVERE sleep deprivation. He ruled the roost on when everyone could sleep…every night would consist of temper tantrums until he just collapsed of exhaustion.

    So, it seems like, sleep deprivation is okay, misdiagnosing for ADD is okay, prescribing some anti hyperactivity medication is okay, but a few nights of crying is going to cause irreparable harm to your child…things that make you go hmmmmm.

  27. No, that’s not what I’m saying.

    Six month old children, as I understand it, get about 16 hours of sleep in a 24-hour period. They get it on a distributed schedule.

    Children who are not getting that amount of sleep plus or minus the standard deviation would fall into the category “sleep-disordered”, and IRBs would be more likely to find that benefits to the children of a particular sleep-training therapy might outweigh the known harms. But children who *are* getting that amount of sleep, just not on a schedule that suits the parents, would not fall into that category.

    • Actually, Caryn, if you (as an adult) are sleeping 8 hours a night but waking up multiple times during your main sleep period, chances are the quality of your sleep is the pits. 6-month-old babies aren’t much different in that respect. And I don’t think you need a formal diagnosis of “sleep disorder” to reap the benefits of a sleep training program.

      All this is getting away from the fact, though, that the petitioners who are objecting to this research are claiming possible harm will be done to the baby who is subjected to CIO – not mere distress, but actual, permanent harm.

  28. No, we can’t class the majority of six-month old babies as sleep-disordered if it is the case that the majority of them get their sleep in a distributed pattern. Because then it is statistically *normal* for them to get their sleep in a distributed pattern. That’s what the term *normal* means. The majority of adults get their sleep in a chunk; and that’s normal for adults.

    I can see why they’ve hypothesized permanent harm, but I think, as you point out, that we have observational evidence to the contrary. For an IRB, though, it is true to say that temporary psychological harm, signs of distress like crying, and so forth count as harm from a benefit/harm standpoint.

    Think of it with the Alzheimer’s patients. Could we ethically subject them to a situation where they’re getting the same amount of sleep but on a different schedule and they’re evidencing signs of significant emotional distress like crying uncontrollably? And we’re counting as a indirect benefit that because it gets more sleep for their caregivers, it makes their caregivers happier so that they give better care to the Alzheimers patients when they are caring for them?

    And the answer to that is, no. We’d have to make their caregivers happier by some other mechanism, like reducing their caregiving schedule in some fashion that enables them to get sufficient sleep. Or at least this is what a philosopher would say. (Not all IRBs have philosophers.)

    In *practice*, with an individual patient-caregiver pair, this may or not be possible. But a researcher running a study is required to adhere to higher standards.

  29. The thing is it really isn’t only the parents who benefit from CIO or sleep training. As it has been mentioned in previous comments, the child often benefits from the increased sleep as well. Frequently the CIO isn’t just about getting the child on a schedule the parent likes, but helping the child get an adequate amount of sleep.

    At least that is how it was in my case with my son. Nothing worked to get him to sleep- not rocking, not nursing while he was breastfed, not singing, patting, etc. Only leaving him to cry a bit. If I wasn’t willing to let him cry a bit he WOULD NOT be napping. I really tried everything before leaving him be to fall asleep on his own. And while he was learning to fall asleep, and not napping he was miserable- overtired during the day which effected his night time sleep as well. Which is how he would be every day if I wasn’t willing to let him cry. Now that he naps he is a much happier baby, and sleeps better at night as well.

    So to say that only the parent benefits from CIO, whether discussing theoretical research trials or individual families, in many cases is inaccurate. Sleep deprivation in an infant, toddler, or adult can be very serious (see Healthy Sleep Habits, Happy Child). And for a significant number of babies, CIO helps them get adequate sleep. However, no one on this site has ever said that CIO works for all families or even that is should work for all families. Just that it can be a helpful tool for families who all need more sleep. And when done in the context of a loving family does not cause harm.

  30. Caryn, it seems to me that your outline of the ethical problem of causing distress to an infant in the interests of research is perfectly valid. I’m not sure that brief crying in itself constitutes “psychological harm” unless it is very extended. I suppose I tend to equate crying as more of a warning, a protest, that could only be damaging if allowed to get completely out of control.

    However, I am not sure that it can be compared to Alzheimers sufferers and their carers I am, thankfully, no expert on that dreadful affliction, but I would have thought that some of the distress would be a residue of adult griefs, not a simple reduction to infant patterns? An emotive argument, but not really parallel.

  31. More than that, I really don’t think you can draw a valid comparisons between the parent child relationship and that of an Alzheimer’s patient and his caregivers. They are qualitatively different.

  32. Well, what’s a better analogy? I picked Alzheimers partly because the caregivers are often the children of the patients, and because they cannot, in the severe stage of the disease, communicate their distress via other mechanisms.

  33. Bit of a red herring, really, but I would second Nancy assertion that there is a diffeerence – possibly hard to pin down – between a carer and a parent – especially an anxious parent of a “helpless” infant. I am frequently conscious of slipping from one role to another in my daily life.

    Also IS crying purely and simply a sign of distress? Isn’t is sometimes simply a form of communication, a sign of frustration, mild discomfort? Is the wailing toddler on the way home from the park suffering psychological harm? No caring parent is going to let a child suffer acute distress – and surely it isn’t that hard to tell the difference?

  34. There is no analogy you can make. That’s the whole point.

    As I’ve said earlier I think it’s wrong to make the distinction you are trying to make in the first place. If you can find a way to test your hypothesis without interfering with the relationship between infant and its parents then by all means go for it.

    Otherwise you introduce something to the dynamic in that relationship that wouldn’t be there under normal circumstances. That will change the relationship and taint the results of your study.

    You can see it already in some of the comments in this thread where you’ve posed the question of infants interests versus parents. People have taken that assumption on board and started a balance sheet with baby on one side and parent on the other.

    This is not an obvious distinction.

  35. Liz, I’m saying explicitly that an IRB or a medical researcher *cannot* make the assumption that crying is not a signal of distress, because they don’t know the child in question. They also must guard against the possibility of encouraging the parents to act unethically by virtue of their authority. (Are you familiar with the Milgram experiment?)

    No doubt the suffering of the Alzheimers sufferer is different in various ways, but what is relevant is the severity of the harm. The best guide we have to determine whether two different individuals are experiencing similarly severe psychological harms is by comparing their behavioral responses. When those responses are non-verbal, that means relying on non-verbal ways of expressing displeasure, anxiety, fear, etc. If both the infant and the Alzheimers patient are, say, crying equally vociferously, then it seems reasonable to conclude that they are roughly equally distressed. Notice that we use this criterion for measuring the severity of psychological distress all the time.

    If the research protocol causes the infants to cry severely, then we have reason to think that they are being distressed about as much as the participants in an adult study would be if they were caused to cry severely. And I’m pretty sure that any study that caused adult participants to cry severly (say by scaring or shaming the participants) would have to promise significant benefits to the participants to get past an IRB.

    As for the assertion that we cannot break apart the interests of infants and their parents, Nancy, I’d point out that the interests we’re talking about here are experiental. The baby and the parent do not have the same experiences. They have their own. You can only get rid of the distinction between the interests of infants and their parents by either jettisoning political liberalism (the idea that people have rights) or by jettisoning the idea that infants are people. Because IRBs are generally unwilling to do either of those things, they’re bound to treat infant and parental interest separately.

    Also, I have no hypothesis here, and in particular do *not* have the hypothesis that CIO causes lasting damage to children or should not be used judiciously by parents, who (as I’ve asserted in multiple places above) generally have perfectly good judgement about these matters. I am talking about whether or not it is ethical for an IRB to give human subjects research approval to conduct a study.

  36. No connection to what Caryn is saying, but I had to share this link about the effects of sleep deprivation:

    http://www.divinecaroline.com/article/22178/70567-surprising-consequences-sleep-deprivation

    Certainly not necessary to read the whole thing but I thought this quote was funny given what the anti-CIO crew claim they are concerned with:

    “Sleep-deprived athletes also experience high levels of cortisol, a stress hormone, as well as lower levels of human growth hormone, which is important for muscle repair.”

    OMGZ, cortisol levels elevated!

  37. I’ve been attempting to follow all of these comments and some of it seems to be going over my head. I dont’ know if its’ the fact that in my time zone it’s 1:30am and I should be in bed. I am reading about all this sleep deprivation and realizing I’m in that category! {ha-ha}

    I really want studies done that can factually link adult issues to the fact that they were CIO babies. Until this actually happens I’ll continue to let my baby get her uninterrupted 12 hours of sleep a night and two-2.5 hour naps a day plus a 1.5 hour nap in the morning. She’s the happiest thing I’ve ever seen. She started sleeping thru the night at 6 weeks, going 8 hours all night without a peep then.

    My personal thoughts on “harmful” CIO is when you let it go on for more than about 15 minutes. Those folks who use CIO and allow their babies to cry for an hour or more, I believe, are just plain stupid. IMO if a baby is crying for more than an hour there is something you’ve missed and it’s not the sleep train! So I think there are ways you can use CIO and not cause the baby undue stress.

  38. I really want studies done that can factually link adult issues to the fact that they were CIO babies.

    I’m afraid I am getting increasingly fascinated by this topic – particularly by the idea that there are these poor deprived CIO infants destined to adult trauma and the cosseted babes who sleep on their mother’s breast.. I have to confess I have not followed the full details of this debate on AP type boards, because when I read too many of those sanctimonious posts, I kind of lose the will to live. Is there no room in modern mothering for “do what works for you”? So I am a bit vague on the details. If you have a child who happily sleeps in a cot from the start, are you still committing the sin of separation? No-one is going to dispute that letting a baby cry frantically for long periods requires a degree of indifference incompatible with good mothering, but is that what this is about? It seems to me that a false dichotomy is being set up bolstered by dire and vague threats of long term consequences – consequences that might be rather hard to pin down in your average adult psychopath. And I love the way “brain damage” or IQ points are used to bolster these arguments. As if the highly intelligent suffered less from life’s traumas than others. Always thought there was much to be said for being dim, myself. Less likely to agonise over minutiae.

    I read Bowlby when my first was an infant. I found it profoundly depressing. Was mothering really such a high risk, high stress affair, where every false move had awful consequences? Maybe it is, but, count on it, you will mess up somewhere. Maybe the profoundest childhood traumas go unnoticed at the time. I had a lousy, near abusive childhood – I seem to fare as well as others who were more cossetted. (My husband, for one, who is far more neurotic and less able to cope than I am). Not recommending it, on the grounds that “it didn’t do me any harm”. It did. It meant I took much better care of my own children, though. Still got it wrong from time to time.

  39. Just in passing: as I have said, my first, very vulnerable child screamed for weeks – immature, damaged nervous system. I was relieved to find I could cope with it without too much distress – offering her what comfort I could, cuddling and soothing until the storms passed. I had a lot more trouble with older children. When they cried from the shock of a tumble, the grief of a broken toy, or the disappointment of not having chocolate for tea, it would awaken in me memories of the neglected child I had been, the unheeded crying, and I would need to pacify in ways which were not always appropriate. I’ve discussed this with my adult daughter, who was aware of it, and knew which buttons to press. Complicated creatures, human beings.

  40. “It seems to me that a false dichotomy is being set up bolstered by dire and vague threats of long term consequences ”

    Bingo! The gentle AP/NP group love to do this. Another piece of wisdom they’ll impart is that it’s bad to let a newborn CIO, duh, really?! Here I was going to pop the three day old in the bassinet and head off to the spa. My tot is now two and here are two threads about this on my ‘birth board’. There are kids who haven’t had a decent night’s sleep in *two years* and it’s still cruel to let them cry a little bit. The mind it boggles.

    http://community.babycenter.com/post/a6751335/sleep_-_trouble_again._cant_be_put_down._help

    http://community.babycenter.com/post/a6947495/anyone_w_sleep_problems_who_doesnt_cio

    • OMG, that second Babycenter thread…as you say, the mind boggles. Complete with Doc Sears scaremongering and women who “ERF”…who knew that was the new virtue these days? Lisa asked for me to do a post about it, but I had no idea the crazy reached such proportions!

  41. Liz, am I remembering that you’ve checked out some of Hrdy’s work? She’s got some interesting stuff on maternal-fetal conflict and Bowlby that you’d probably enjoy reading.

  42. (maternal-infant conflict, rather. Work seeping in, sorry!)

  43. About the ERF thing – I give up!
    That is arse backward – literally.

  44. I didn’t think that thread was too awful – but then I don’t know what ERF is.
    There is a huge difference between “I can’t deal with crying” and “Crying does irreparable harm” What drives me crazy is the inventing of an ersatz philosophy to justify one’s personal foibles, and then using it to bully others, or assert one’s superior skills. Some babies sleep easy, some don’t, and I don’t think mothering skills have much to do with it. My first needed little sleep, and is still not that keen, as an adult, in acknowledging much difference between night and day – or, come to think of it, on separation from me. Maybe all that “attachment” during the day makes them less secure?

    Out shopping in trendy Islington, London N1 yesterday, I saw several mothers “wearing” their babies. With most, it looked practical and natural, but one had an ethnic type sling and was wearing hers with smug, attention seeking flair which screamed “I am the crunchiest of the crunchies” – and you just knew she would be an absolute pain in the arse to any other mother foolish enough to engage with her. I really don’t believe that women like that are motivated solely by the best interests of their children.

    • ERF=extended rear facing (in a carseat). I’d never heard of the term until clicking on a link in someone’s siggy on the thread, either. Apparently the newest thing in the Mommy Wars, though why – I have no idea.

      Liz:”There is a huge difference between “I can’t deal with crying” and “Crying does irreparable harm” What drives me crazy is the inventing of an ersatz philosophy to justify one’s personal foibles, and then using it to bully others, or assert one’s superior skills.”

      It’s actually more like misquoting and misusing science to lend credibility to one’s favorite (invented) philosophy.

      And I’m not sure I agree that “Some babies sleep easy, some don’t, and I don’t think mothering skills have much to do with it.”. I would guess that babies’ sleep and self-soothing abilities fall along a spectrum – some babies are naturally good sleepers, some are naturally bad ones (Caryn’s son would probably fall into the latter category), but most fall somewhere in the middle and are amenable to changing their sleeping habits via behavior modification, with varying degrees of ease or difficulty. Mothering/parenting skills, if one is willing to use them as a matter of philosophy, can make all the difference.

      I stumbled upon an interesting article on the subject of cosleeping whose first few paragraphs demonstrate this process. Of course, some of the commenters blast Dad (who suggested, then insisted, on the behavior modification) for bullying his wife into “ignoring her instincts”.

  45. Yeah, b/c dads never have any instincts worth paying attention to. They just there to help lifting heavy things and to do math… math is hard.

  46. I didn’t mean to denigrate mothering skills – clearly a sensitive and caring mother can help a child through transitions – more to let some of the hook. I had an easy baby and a difficult one – so did my sister – and I seem to remember that some mothers chalk every “victory” up to their skills “Your child doesn’t sleep/feed well/use a potty? Mine does!” Even infants seem to have clear temperamental differences from the start. My first, having a lot of problems, was always very hard to handle, but being temperamentally very like me, I managed to read most of her cues. I called my second The World’s Easiest Baby, but never found her as easy to “read”. My granddaughter fascinated me – she was very active and lively from day 1, didn’t like being held, and would never fall asleep anywhere but in her cot or bed, no matter how tired. She toilet trained herself by announcing she didn’t like nappies.

  47. Esther, the misuse of science to back up one’s claims is rampant. Why? Because science is an epistemology everyone agrees with. But the second we come up with scientific evidence to the contrary of the claim, the dodge turns into some pomo gibberish — witness the “well, you’re just coming from a different paradigm!” claims — or into an exhibit of scientific illiteracy, wherein the claim that one poorly done study from years ago trumps all the newer evidence simply because the individual in question prefers that conclusion. Which is like having a preference for the studies that confirm geocentrism.

    The entertaining thing about that, of course, is that we are coming from a different paradigm that is wrong, except that all paradigms are equally valid.

  48. Sorry. 🙂

  49. The CIO debate… always a painful one. 🙂

    Caryn, it’s interesting you say all crying causes psychological harm. I let my three year old cry on the way home from the shop today because he couldn’t eat his sweets before dinner…. do you think this will cause him brain damage?

    My 12 week old has a shout before sleep every nap and night time, a real holler for about 5 minutes! lol

    If I were to pick him up, it would only delay things and I’d have to put him down and he’d holler again. It is like he is shouting to release the tension of the day before he goes to sleep. He sleeps all night and we all have fun days because we’re well rested.

    Many of the questions I get on my sleep blog are from parents who have co-slept/ fed baby to sleep right from the start. So baby never learns how to fall asleep without help. I feel this is such an important life skill that I don’t understand why it is considered “wrong” or “cruel” to allow a baby to learn to sleep by themselves.

    Look at the evidence on the attached link to see the damage that can be caused by not teaching children how to sleep or giving them the opportunity to learn these skills by themselves.

    http://news.bbc.co.uk/1/hi/health/8016531.stm

    There is no need for prolonged crying, leaving a young baby alone to cry for hours. But inevitably a little crying may be involved for a short while as a baby develops this important skill.

    If a baby took her first steps and was to fall over and cry, should we never let her try and walk alone again in case she cried again? And on the first day at nursery or school when a pre-schooler cries – many of us will know how that has felt – should we take our children home with us and never let them go to school again?

    Sleep is just the first step, a small piece of independence that we give to our babies so they have the conditions they need to grow, develop and learn in these early, challenging years. Our role as parents is to support our babies and children as they make their way into the world. To encourage and guide – but not to do everything for them.

    Sleep is no different from any other skill they must learn. It amazes me that it is such an emotional issue and that parents struggle with lack of sleep for years, toddlers who are so tired their behaviour is out of control, and babies who are always crying because they are so tired, when there is a simple solution to help everyone – let your baby learn to fall asleep by himself….

  50. Lucy, I don’t think you’ve read what I said above very carefully.

  51. WOW, I could reply with a long well thought out answer, but you sound like you are very entrenched in your ideas and I’m not going to spend the time. WOW, just wow. I’m sorry to be insulting, but your blog is very ignorant.

    • Well, I’d like to see a “long well thought out answer” from you, but I doubt it’ll be forthcoming. It’s usually an ignorant (not to mention cowardly) person who comments this way, and hides behind a fake email addy of “wow@youreallysuck.com” to boot.

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