Essential Nelson Pediatrics Pdf Free Download
Avery Blaschko
The following is a list of essential medical apps Pediatrics providers should have on their smartphones. Links to iPhone and Android platforms are provided for each app. The apps are listed based on my experiences working as a full scope Family Medicine physician including obstetrics and pediatrics as well as the app reviews that have been done previously at iMedicalApps.
Login to iMedicalApps in order to view the following video review of The Essential Medical Apps for Pediatrics. Registration for iMedicalApps is free, or you can continue to read the full text version of the list.
Doug is currently is the Program Director of the Madigan Faculty Development Fellowship at Fort Lewis, WA. He is a Fellow of the American Academy of Family Physicians. His research interests include medical simulation, prevention of obesity and evidence based medicine at the point of care.
iMedicalApps is an independent online medical publication for medical professionals, patients, and analysts interested in mobile medical technology and health care apps. Our physician editors lead a team of physicians, allied health professionals, medical trainees, and mHealth analysts in providing reviews, research, and commentary of mobile medical technology. Our publication is heavily based on our own experiences in the hospital and clinic setting.
DR. GUTMANN: Thank you. Could I invite our first presenters up to the table, please, and thank you all for being here. I thank you, before we get to ask you the hard questions, which you then may not thank us for being here.
We're going to begin our day with the discussion of Special Considerations for Research on Children because that's the fundamental issue that leads us to be dealing with this charge and we have with us Dr. David DeGrazia, who's a Professor of Philosophy at George Washington University. Welcome, David.
But how should we understand these rights? At least in this context, I suggest that we understand the relevant rights as side constraints or trumps, as setting strict limits on the pursuit of even the most important goals.
Rights should not be taken as values to be balanced against the goals of research. One sometimes hears people talking about appropriateness of balancing the goals of research with subjects' rights. I think that's not the way to think about it because otherwise the vital interests of subjects might be swept away in the tide of appeals to societal benefit or social utility.
One provides valid, that is, voluntary informed consent, if and only if one consents to participate in a protocol intentionally, with sufficient understanding of the nature of the study, its risks and possible benefits, and sufficiently freely of both external constraints and internal constraints.
Some mature minors are probably capable of informed consent, even though they count as minors under the law. All other minors are not. They tend to lack sufficient understanding and/or sufficient freedom from such external constraints as their dependence on adult authority and the internal constraints that are associated with their own immaturity.
But autonomy and capacity come in degrees. They're not all or nothing. That means most minors have them to some degree and we should therefore take the minors' wishes into account as to whether he or she wants to participate in research.
Accordingly, I think the common practice of requiring the minor subjects' assent, along with proxy permission, is a good practice. I note, however, that some exceptions are possible and, if appropriate, we can talk about those later.
Meanwhile, the best interest standard applies to nearly all minors. It's generally understood to permit research on children when there's only minimal risk or a minor increase over minimal risk, if certain conditions are met, or direct medical benefit that compensates for any risk.
But note. If we take the language of best interests in a literal maximizing way, this standard presumably prohibits research on children whenever they face any risks that are not offset by the prospect of benefit to them because the concept of best implies a kind of maximization.
I suggest that we not take this term so literally. Instead, I think we should understand the best interest standard as protecting minor subjects' essential interests. This extends the idea that parents owe their children protection of their essential interests, including adequate protection from harm, but what constitutes such protection from harm in the context of pediatric research?
Children may be involved in promising research that either offers direct medical benefit that compensates adequately for any risk or no direct medical benefit but relatively minor risks that are compatible with the protections that responsible parents would afford their children.
So here, there's an appeal to what good responsible parents would do in protecting their children and making decisions for them. It leaves a lot open to discussion but it's somewhat analogous to the way in which the law sometimes appeals to the reasonable person.
So if this standard is right, then pediatric research, outside of these categories, violates children's right to adequate protection from harm and since we should understand rights as limits or side constraints, that would mean that research falling out of these categories just should not be done.
Dr. Nelson served as a Member and former Chair of the FDA Pediatric Advisory Committee and the Pediatric Ethics Subcommittee as well as a Member of the Subcommittee on Research Involving Children and the Secretary's Advisory Committee on Human Research Protections.
He was also a Member of the Committee on Clinical Research Involving Children at the Institute of Medicine and a Member and former Chair of the Committee on Bioethics of the American Academy of Pediatrics.
I think at this point, we understand that we should protect children through research as opposed to protect children from research and because of that, we have an obligation to assure that there's adequate data for the safe and effective use of drugs, biologics, and devices, in infants, children, and adolescents.
This need for data underscores our responsibility to make sure children are only enrolled in research that's both scientifically necessary and ethically sound and children, of course, are considered vulnerable persons and thus require additional protections.
The first one is that children should only be enrolled in a clinical trial if the scientific and/or public health objectives cannot be met through enrolling subjects who can provide informed consent personally.
The first principle of scientific necessity I link to the requirement for equitable selection. If you look back at the National Commission's report, this is where they spoke about the obligation to enroll adults before children and not to enroll children unless essential.
So I'm going to walk through some key concepts as part of these regulations. First is prospect of direct benefit. First of all, it's a benefit for the enrolled child. It's based on the structure of the intervention and not intentionality. The level of evidence that you need is lower than that of efficacy, otherwise it's an infinite loop, can never get there, whether it's sufficient to justify the risks is a complex judgment, similar to clinical practice, and basically the child should have as good a chance for benefit as the clinical alternatives.
Now extrapolation basically is where the course of the disease and the effects of the drug are sufficiently similar that we can conclude from adult efficacy trials that we can get safety in dosing studies in pediatrics and say that it would work in pediatrics.
There's different approaches to that. We may not require any efficacy studies or we may require partial studies that can confirm our ability to extrapolate. There is a published article on this in Pediatrics that I can give you the reference to, it's not on this slide, if you'd like more information about it.
But extrapolation is an important concept as we look at pediatrics. Here's one example where both prospect of direct benefit and extrapolation worked together. One is in the proposal to enroll adolescents in an HIV vaccine trial.
The second would be if we could extrapolate, we would not need a large enough sample size to where we would do adolescent efficacy but could still end up with concurrent licensing because we've enrolled enough adolescents to make a descriptive comparison between their immune response and the adult immune response, and there's a publication where you can read more about this.
Component analysis is another important idea. Protocols can contain both procedures that do not offer prospect of direct benefit or procedures that do offer prospect of direct benefit and basically you need to take that protocol and analyze it in those component parts.
If you don't do this, the concern is that you could end up with an intervention in that protocol that does not offer a prospect of direct benefit but that exceeds the acceptable limits of a minor increase over minimal risk, unless you referred it for federal panel review.
Here's one example of a trial that used placebo administration that went in for IV infusion four hours each day for 14 days. A limited number of sites in this trial actually approved the use of a central line without adequately considering that this meant that you were placing percutaneous central lines into children that were in fact going to receive placebo and this was felt to be inappropriate and that they should have sought other ways to maintain blinding than putting in central lines in kids that needed placebos.
The minor increase over minimal risk category has this language about disorder or condition and the need to generate generalizable knowledge that's of vital importance for understanding this disorder or condition.
There's no definition within our regulations. Here is one definition that was proposed by the Institute of Medicine in their 2004 report, where you look either the disorder or condition as the child has a disease or it is at risk for a disease, and so this notion of being at risk for a disorder or condition is an important aspect of deciding whether research is appropriate or not, and here's one example of that.
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