The Conversing Nurse podcast
Are you a nurse curious about the experiences of other nurses? For 36 years, I have only known the Peds/NICU realm but I am intrigued by the roles of nurse researchers, educators, and entrepreneurs. Through conversations with nurses from various specialties, I aim to bring you valuable insights into their lives. At the end of each episode we play the five-minute snippet, just five minutes of fun as we peek into the 'off-duty' lives of my guests! Listen as we explore the nursing profession, one conversation at a time.
The Conversing Nurse podcast
Summer Series: Research 101-Part TWO
Welcome back to the summer series, Research 101, this is Part Two. I'm once again joined in my closet by Chris Patty, and you may be wondering who I let in my closet, The answer would be only those closest to me and Chris is my brother, so he qualifies.
Last week in Part One, we covered the history of research, what research really means, a little about nursing literature, and a lot about the incorporation of AI in our field. If you missed it, I highly recommend tuning in!
In this episode, we delve into what comes next after formulating your PICO question—remember PICO stands for problem, intervention, comparison, and outcome. This question serves as the basis for your protocol when you present to the institutional review board, or the dreaded IRB, which can be a bit intimidating. Chris provides an insightful breakdown of the IRB's role, the key players involved, what’s required in your protocol for approval, and the timeline for this process, which, as I learned, can sometimes depend on how fat your wallet is!
One key highlight I enjoyed was Chris's discussion around evidence; he emphasized that the highest level of evidence comes from meta-analyses and systematic reviews, which sit at the top of the evidence hierarchy. Could the Framingham study be one of these? So many great gems in here!
Don't forget to check out my CE Library at RNegade.Pro, because, good news: this series is eligible for CE credits! The link will be in the show notes. Here’s Chris Patty.
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Thanks for listening!
[00:01] Michelle: Welcome back to the Summer Series: Research 101. And this is part two.
[00:06] I am once again joined in my closet by Chris Patty,
[00:11] and you may be wondering who I let in my closet.
[00:14] The answer would be only those closest to me. And Chris is my brother, so he qualifies.
[00:21] Last week in part one, we covered the history of research,
[00:25] what research really means,
[00:27] a little about nursing literature, and a lot about the incorporation of AI in our field.
[00:34] If you missed it, I highly recommend tuning in.
[00:38] In this episode, we delve into what comes next after formulating your PICO question.
[00:44] Remember, PICO stands for Problem,
[00:47] Intervention, Comparison, and Outcome.
[00:51] This question serves as the basis for your protocol when you present to the Institutional Review board or the dreaded IRB.
[01:01] Because they can be a bit intimidating,
[01:04] Chris provides an insightful breakdown of the IRB's role, the key players involved,
[01:10] what's required in your protocol for approval, and the timeline for this process,
[01:15] which, as I learned, can sometimes depend on how fat your wallet is.
[01:21] One key highlight I enjoyed was Chris's discussion around evidence.
[01:26] He emphasized that the highest level of evidence comes from meta analyses and systematic reviews, which sit at the top of the evidence hierarchy.
[01:36] Could the Framingham Study be one of these?
[01:40] So many great gems in here.
[01:42] Don't forget to check out my CE library at Renegade Pro, because, good news,
[01:49] this series is eligible for CE credits.
[01:52] The link will be in the show notes.
[02:10] Good morning, Chris. Welcome again to my closet.
[02:15] Welcome back. I should say today it's a little cooler in here.
[02:19] We have set up a different ventilation system.
[02:23] Chris: Yes. Looks good.
[02:24] Michelle: Yes.
[02:25] So we are here for part two. Part one,
[02:29] I'm sure you remember, was Introduction to Research.
[02:33] We talked a lot about why we do research and the benefits of it.
[02:39] And also you talked a lot about AI.
[02:43] And I want you to do a special episode on AI. But before we do that, we're going to launch into part two,
[02:50] and if you haven't listened to part one already,
[02:54] go back and listen to it. It's a good basis.
[02:57] But what are we going to talk about in part two?
[03:00] Chris: Well, I thought in part two, we would get a little bit more maybe technical,
[03:07] and we'll now sort of assume that one wants to do some nursing research and, you know, they've figured out, you know, what kind of things they could study, what presents a problem to them or a question or maybe they have attacked the issue of what needs to be overhauled in nursing research.
[03:28] So they say, okay, I'm gonna, I'm gonna do it. I'm gonna commit to it.
[03:33] And some of the little bit more technical parts that we'll talk about today are again, formulating the research question.
[03:42] Because everything in research, no matter what type of research it is,
[03:47] whether it's research in nursing or research in,
[03:50] you know, metallurgy, it all starts from the question. It flows from the question.
[03:56] So if, and we talked about the common language, but if you come to me and you give me your PICO- formatted question and I could close my eyes for five seconds and I know what you're going to do when you study.
[04:10] I know what you're going to be studying, how you're going to study it.
[04:14] Michelle: And remind us what the acronym PICO stands for.
[04:18] Chris: Yeah. So PICO stands for Population, Intervention, Comparison, and Outcome.
[04:28] So it is a way to frame a researchable question. Remember,
[04:33] a researchable question is one that we can answer with data.
[04:38] If there are no data,
[04:40] we can't answer the question. It's not researchable. It'll have to wait till AI improves.
[04:46] So we'll talk about the, about formulating the research question.
[04:50] PICO is the most common format we use. We will talk a little bit about a particular research question. Formatting,
[05:01] I'm gonna say scheme is fine.
[05:03] Called SPIDER,
[05:05] which is for qualitative research.
[05:08] Michelle: My favorite.
[05:10] Chris: Yeah. And as we discussed, much of nursing research falls into the qualitative domain.
[05:18] So we'll talk about that, and then we'll talk about how the research question becomes a plan to do your study.
[05:27] That plan is called a protocol.
[05:29] And how that protocol gets approved by your local, or it might be national, if you're living out in the stick somewhere without access to a local institutional review board or IRB.
[05:44] So I'll talk a little bit about the IRB.
[05:47] Michelle: The dreaded IRB.
[05:48] Chris: The dreaded IRB. And there, and there is some basis for dread.
[05:52] There's been research done on IRBs.
[05:55] There's been research done on almost everything that anybody cares about.
[05:59] And so, for example, if you look at,
[06:03] you know, metrics of IRBs in terms of their performance,
[06:08] It's very common for approval to take four to six months for a study through an IRB because they have a calendar and they only meet on the second Tuesday of every month.
[06:19] Michelle: Yeah.
[06:20] Chris: And if you miss it by a day, then you're into you know, you got a month to go and then if you submit your protocol and they have a bunch of questions about it and they say, well,
[06:31] I think you need to address this a little bit differently. And it's already the meeting day when they decide that then it's next month that they get to review it.
[06:41] So if you're in a system like the, the, the famously delaying IRBs or in the Veterans Administration where you know, they take a year,
[06:53] you know, to get through and approve a protocol to ask a veteran about smoking or something like that.
[07:00] So, so there is a little bit of basis for trepidation when approaching your local IRB
[07:06] But there's also,
[07:10] if you want to spend the money,
[07:11] there are for profit national IRBs that run very smoothly, very slickly.
[07:19] Michelle: That seems like a conflict of interest.
[07:21] Chris: That's no conflict.
[07:22] Michelle: No?
[07:23] Chris: Well, there's always a potential conflict. But no, they're, and these are big. These,
[07:28] these work for pharma, these work for small organizations that don't have the resources to maintain their own IRB. But things that, you know, we talk about greasing the wheels with money.
[07:43] So when you come to my IRB at little Visalia,
[07:48] doesn't cost you anything.
[07:49] Michelle: Right.
[07:50] Chris: And matter of fact, you show up in front of the IRB
[07:53] we'll even give you a free sandwich and water from Panera. If you call up the,
[07:59] you know, used to be the Western IRB or the Sterling IRB or you know, one of these national for profits,
[08:07] they'll, they'll be very sweet and they'll be very welcoming and they'll take a look at your PICO for $5,000.
[08:18] But they'll do it quickly.
[08:19] Michelle: Yes.
[08:19] Chris: And they'll have their turnaround metrics posted on their website. But every time you interact with them, there'll be a charge. Just like calling an attorney.
[08:29] Michelle: Sure.
[08:30] Chris: You know, my daughter, is an attorney. My daughter-in-law is an attorney.
[08:34] Michelle: Yes.
[08:35] Chris: You know, they got the app on the Watch,
[08:37] Billable Hours app.
[08:40] Hello, this Laura,
[08:42] push the button,
[08:44] starts charging, bill it in six minute increments.
[08:47] 10 per hour.
[08:50] So they'll do stuff like that. Okay, but we'll get to that.
[08:54] So the research question remembered. Everything flows from the research question.
[08:59] The research question is a, there's a little bit of a paradox with the research question. The research question is very important also. You may know or you may notice, maybe now you will.
[09:13] When you read a published research study,
[09:16] there is typically a place where the research question is found.
[09:21] Oh well, the most common place where the research question is found is stuck in the brain of the principal investigator and never articulated in the paper.
[09:32] If it is articulated in the paper, it's generally not articulated as a research question per se.
[09:41] It will say. The last sentence of the introduction will state the purpose of this study,
[09:47] which, the purpose of this study is, you know, is a cousin of the research question, but it's not exactly equivalent.
[09:55] Some really good research. We talked about the evidence hierarchy, the very top of the pyramid. The strongest evidence are systematic reviews and meta analyses of randomized controlled trials such as the Cochrane Collaboration performs.
[10:12] They explicitly require the statement of their research question in those papers. As a PICO matter of fact, you can, they publish all the PICO's in the paper on the website.
[10:24] They tell you if they've done a systematic review of 50 papers,
[10:30] they'll tell you all the PICOs in the 50 papers.
[10:33] Michelle: So can you give us an example of like a succinct research question, what it would maybe look like or sound like?
[10:42] Chris: Yeah.
[10:43] So, you know, a clinical question might be,
[10:46] you know, in older community dwelling women,
[10:52] will the use of carpets versus hard floors produce any difference in the rate of falls with injury over a year, period?
[11:05] Michelle: So it's very specific.
[11:07] Chris: Very specific.
[11:07] Michelle: Very specific. A research question should not be ambiguous.
[11:12] Chris: No.
[11:13] What are we going to do today? Now, that's not a research question, right? That's just what you say to your spouse when you wake up in the morning.
[11:21] No, so research question, you know, the more specific the better.
[11:26] Right. And so, you know, when we're, when we're working to formulate that population intervention comparison outcome,
[11:35] we try to be very specific at the beginning and then, you know, we don't need to forever and ever state the research question as a whole paragraph with tons of, you know, specificity in it.
[11:51] but we want to, we want to know what we're doing. Right? So we try to tease out the elements and get it, you know, get it accurate, get it precise.
[12:00] And it's interesting when you work with particularly novice nurses,
[12:06] it's not always, I mean, it's always hard to actually develop a research question and people really gotta think about it.
[12:15] Michelle: Are they usually not specific enough?
[12:17] Chris: They're usually not specific enough.
[12:20] And you know, a PICO is kind of a one size fits all thing. Right. So, you know, a lot of,
[12:26] you know, there are many things you can study that you got to wedge into the PICO box.
[12:31] Right. So in, in clinical nursing, for example,
[12:35] you by definition have a nurse and patient together.
[12:39] Okay.
[12:40] And they're interacting in some way,
[12:42] or at least the nurse is acting. But typically it's an interaction and sometimes it's difficult. Just as an example, when you're defining the population to say,
[12:54] are you studying the nurse or are you studying the patient?
[12:58] Right. Because the,
[13:00] you know, the 30,000 foot question is, does this thing work?
[13:05] Michelle: Yeah.
[13:05] Chris: Well, does that mean that in the hands of the provider it's effective or does that mean that from the perspective of the client it's effective,
[13:17] but sometimes it's hard for people to wrap their brain around.
[13:20] Michelle: Yeah.
[13:21] Chris: Right. And then, you know, when you talk about study design, you move from the population to the intervention.
[13:27] When, when clinicians think intervention,
[13:32] right. They think you're doing something to somebody,
[13:35] you're going to drug them, you're going to irradiate them, you're going to exercise them, you're going to cut them. You know something.
[13:42] Intervention.
[13:43] Michelle: Right.
[13:44] Chris: An intervention doesn't have to be an action,
[13:47] so it's not to be something that touches the patient. It can be an observation.
[13:53] So in observational research,
[13:56] right. The intervention may be the observation and they may be observing from afar.
[14:03] Right. The subject or the research participant may not even be aware by design that they are being observed. Or an intervention might be the taking of a weight,
[14:16] a measurement.
[14:17] Right. And so, you know, then, so you gotta kind of expand people's paradigm about what intervention means.
[14:25] And then when you, when you get to the C. The comparison, people think, oh, well,
[14:29] you know, every, every, every study I do has to be a randomized,
[14:33] double blind, placebo controlled,
[14:36] you know, dark label study. Because there's gotta be a comparison,
[14:41] you know, and nobody can know what was in there, you know.
[14:45] No,
[14:46] it can have a comparison group, but it doesn't need to.
[14:51] Right. Or the comparison can just be usual care.
[14:55] Right. Which you don't have to really define that. Well, sometimes.
[14:59] And the outcome is probably the, probably the easiest to define.
[15:05] So this is the result of,
[15:07] you know,
[15:08] whatever it is you've planned to accomplish in terms of the intervention with your population.
[15:14] So people get that pretty well. But again, you gotta get the P. Right.
[15:19] To get the O. Right.
[15:21] Chris: Right. So if you have confusion.
[15:23] Chris: About the population being studied, is it the nurse or the patient? And that's actually,
[15:31] it's actually a very common confusion. It's like, what are we studying?
[15:36] You know,
[15:38] in medicine, I would say it's probably a little bit easier,
[15:41] but in nursing, because there is a lot of by design and desire,
[15:46] there's a lot of interaction with,
[15:48] you know, the living human being.
[15:51] Michelle: Right.
[15:51] Chris: And sometimes,
[15:53] sometimes we're studying both in the same study.
[15:56] Sometimes we're studying the actions of the, of the provider.
[16:01] Which. I hate to use that term. Yeah, you know, it's sort of my,
[16:05] a cousin of the term that I always used to slap nurses when they said mid- level.
[16:11] Michelle: Yeah.
[16:11] Chris: You know.
[16:12] Michelle: Yep.
[16:13] Chris: I hate that term. This is a two minute segue. Nurses, please quit using the term mid-level.
[16:20] Michelle: Well, and I actually interviewed. Did you already have a Chinelo Okoye,
[16:25] A nurse practitioner who did her whole capstone project on the use of those terms.
[16:31] Provider, mid-level.
[16:34] Oh,
[16:35] physician extender and.
[16:39] Yeah, because. Well, the granddaddy instead of saying advanced practice nurse or.
[16:44] Chris: Yeah, the granddaddy of all those bullshit terms that you just laid out is the term which is used by physicians.
[16:54] Michelle: Prescriber.
[16:55] Chris: No, non-physician.
[16:57] Michelle: Oh, that was the other one she talked about non-physician.
[17:01] Chris: So it be like me calling you a non-male..
[17:05] Chris: Right. Then it says more about the person saying it than it does about the person they're saying it about. Yeah, but non-physician is a very common word physicians use.
[17:17] Michelle: Non-physician.
[17:18] Chris: Non-physician. There's two kinds of people in this world. Physicians and non-physicians. Now I would, I would submit to you, if you hear the term, there's.
[17:27] Michelle: A lot of non-physicians on the Internet in the comment section.
[17:30] Chris: Yeah, yeah.
[17:32] If you, if you hear the term non-nurse,
[17:35] then you've got a unicorn there. You better study that person because I have never heard that term.
[17:42] Michelle: Maybe we should start referring to physicians as non-nurses.
[17:46] Chris: I think I may start doing that in my next unpaid employment.
[17:52] All right, so we have the research question down.
[17:55] And again, did I give the SPIDER acronym? I did give the SPIDER acronym. You did,
[18:01] yeah. So,
[18:03] but, but really you could use the, you could use the PICO to study both quantitative and qualitative research.
[18:11] So, you have a research question and now you want to put forth a plan to,
[18:19] to carry out the study that you're describing in the research question.
[18:24] Right. So it's a question. It has a question mark at the end of it. Yeah. You know, in the narrative.
[18:30] Michelle: Yeah.
[18:31] Chris: Right. And what you're going to seek to do is you're going to seek to write a plan to do that study. It's called a protocol,
[18:40] and you're going to get the data collection approved by your IRB because that's really what they approve because that's the meat of the interaction with the human subject. So let's back up a little bit.
[18:56] What is an IRB and what do the IRB do?
[18:59] Okay, so the IRB is a federally regulated body.
[19:05] It's actually an ethics committee.
[19:08] And anybody, any person or any organization can apply for essentially a license from Health and Human Services to operate an IRB.
[19:20] Doesn't cost anything.
[19:22] The macro metrics of an IRB are specifications.
[19:29] Federally is that you have to have at least five persons.
[19:34] And you have to have at least five persons because voting is required on some protocols.
[19:40] And you can't have a tie vote, I'm told, with an odd number of voters.
[19:46] Michelle: That would be kind of difficult.
[19:47] Chris: Right. So we have minimum of five. Most IRBs have.
[19:52] Michelle: That makes a quorum. Is that what it's called?
[19:55] Chris: A quorum is defined as 50% of the membership plus one.
[20:01] Michelle: Okay. I remember that before going before the IRB.
[20:06] Chris: So in an IRB of three, a quorum would be.
[20:09] I'm sorry, IRB of five. A quorum would be three. Okay,
[20:13] three and a half. But, you know, rounded off a little bit. In an IRB of 12,
[20:19] like our IRB, 50% would be 6. A quorum would be 7.
[20:24] Michelle: Okay.
[20:25] Chris: All right.
[20:26] Michelle: And who is typically on an IRB?
[20:30] Chris: Typically, who gets on an IRB? There's actually. This is federally regulated.
[20:35] I'm pleased now that, that the federal regulation for gender has been removed because you used to have to have two genders.
[20:45] At this time in our history, the federal government only recognized two genders.
[20:51] You know, things have gotten a little bit, you know, more complicated.
[20:55] But they recognize the genders of male and female. So you gotta have each on your IRB. They quit doing that.
[21:01] But now what you need to have on your IRB is you actually need to have four categories of persons.
[21:07] You need to have what's called a scientist.
[21:10] This is a person who's trained in some aspect of science.
[21:14] You need to have a non-scientist.
[21:16] This is a person who is not trained in some aspect of science.
[21:20] Might be like my mom or, you know
[21:23] Michelle: definitely not a scientist.
[21:24] Chris: A high school history teacher, something like that.
[21:27] Then you have to have an affiliate of the organization that carries the license.
[21:33] And you have to have a non affiliate.
[21:35] You have to have a person outside the organization.
[21:38] And then the fifth person is a wild card. You can duplicate any of the other two.
[21:43] Right. Most IRBs have 10 or 12 people. Some large ones have 40 people.
[21:48] If you go to Stanford, they probably have 10 IRBs.
[21:52] They'll have a Qual IRB and a Quant IRB, and they'll have a drug IRB and a device IRB and a surgical IRB and a psychiatric IRB and an animal IRB.
[22:03] So they have a lot of IRBs.
[22:06] Michelle: Okay.
[22:08] Chris: So the, this group of people get together and they get training and the training usually comes from an organization like citi, C I T I or N I H or there's a couple other private.
[22:23] Michelle: What is CITI?
[22:24] Chris: It's a national organization, been around a long time. They offer a couple hundred courses.
[22:30] The standard course that people have to take is called RCR,
[22:35] Responsible Conduct of Research
[22:38] To get qualified to be an investigator.
[22:43] Michelle: So let's backtrack a little bit. So the purpose of the IRB in looking at your study is to
[22:52] And tell me if I'm wrong, correct me, is to protect the study participants.
[23:00] Chris: It's what we say is to protect the, the participant from the investigator.
[23:05] Michelle: Okay.
[23:06] Chris: It is to protect the human subject. There's only one,
[23:11] there's one type of research that IRBs are charged with evaluating the ethics of the protocol so as to protect the human subject.
[23:24] The research is called human subjects research,
[23:28] and that has a federal definition.
[23:30] And so don't quote me word for word, but it's something like human subjects research is a systematic investigation designed to develop generalizable knowledge and involving interaction with a living human being,
[23:51] their identifiable data or biospecimens.
[23:56] So if your plan to do a study, if your PICO says, I'm going to in some way interact with a living human being or their identifiable data or biospecimens, then it meets the federal definition of human subjects research.
[24:13] And it requires approval by this ethics committee called the IRB before you can begin collecting data. Because that's where the interaction comes in.
[24:25] Michelle: Right. And he identifiable, what did you call it?
[24:30] Chris: The identifiable data or biospecimens.
[24:34] Michelle: Okay, so the identifiable data would be the person's name, date of birth, medical record number.
[24:42] Chris: Yes.
[24:43] Michelle: Social Security number.
[24:45] Chris: Right, Those kind of things.
[24:46] Michelle: Yeah.
[24:47] Chris: It could even be a facial photograph.
[24:50] There's, you know, 21 identifiers or something specified. Okay, and now we recognize a biospecimen, something that contains DNA.
[25:01] That's what I was going to say as identifier.
[25:03] Right, because that has their DNA, which is an identifier.
[25:05] Michelle: What about fingerprints?
[25:07] Chris: Well, fingerprints are,
[25:09] you know, have been always considered a unique identifier.
[25:13] Attil, you may have read recently that AI did a study and said they're not they're not a hundred percent unique.
[25:23] And, and actually what's been found is that,
[25:27] you know, two people can actually have the same.
[25:31] One person can actually have two identical fingerprints,
[25:35] and two people can actually have the same fingerprint,
[25:40] but not if you look close enough.
[25:42] But if you're only looking as close as forensic science normally looks, then they could be, they could look identical.
[25:50] But if you look deeper than, they're not identical.
[25:52] Michelle: So that could revolutionize, like.
[25:54] Chris: Yeah, yeah. Well, we'll just go to DNA for identifying. Okay,
[25:58] So human subjects research operationally.
[26:02] Looks like you know, working with a living human being to collect some data to answer a research question could be,
[26:12] physiologic metrics, performance metrics,
[26:16] attitudes, beliefs, whatever. You're going to collect or identifiable information. This most likely in the healthcare scenario involves looking at medical records, for example,
[26:28] or biospecimens. So looking at something under a microscope that used to belong to the patient.
[26:34] Michelle: Question: IRBs have not always been around.
[26:41] Chris: IRBs are, are.
[26:42] Michelle: Was there, was there a reason why they were put in place?
[26:46] Chris: Yeah. No. Thank you for asking that question. So IRBs, as constructed now have essentially been around since the 1970s.
[26:55] Michelle: Okay.
[26:56] Chris: So it's a relatively new creation.
[27:00] Michelle: What a great decade.
[27:01] Chris: Yeah, yeah, the 70s were a great decade.
[27:03] Michelle: I remember that well.
[27:05] Chris: So the 70s saw a influential position statement called the Belmont Report,
[27:14] which is still the basis of ethics review for research.
[27:20] And the Belmont Report came out in the 70s and basically has three legs to it or three legs to the stool. Right.
[27:27] You know, so it, it says that,
[27:32] for a research study to be ethical, it has to consider three things about interaction with the human subject.
[27:40] Right. It says you have to be fair.
[27:43] Right. And fair.
[27:45] Actually says. It says equal. That says fairness. So fairness is the thing,
[27:52] you know, if you're studying something that's found in every human being and you can't just say, we're going to study this in, in black people,
[28:00] particularly if it inconveniences the human subject.
[28:04] So an example of a violation of fairness in the past would be the Tuskegee Syphilis study, which you guys have probably heard about. Right.
[28:13] Michelle: That was primary in my mind.
[28:14] Chris: Don't confuse that with the Tuskegee Airmen.
[28:17] Right. So the Tuskegee Airmen were not part of the syphilis study. This was a wing of US Army Air Force back in World War II. But the Tuskegee Syphilis Study was a 40 year longitudinal observational study.
[28:32] And the question was,
[28:35] what would happen to a person infected with syphilis
[28:39] over their lifetime?
[28:40] What kind of problems might they develop? Might they cure it themselves?
[28:45] What kind of things would happen? It was observational.
[28:48] And even though.
[28:49] Michelle: So there was no intervention.
[28:50] Chris: No intervention. Just.
[28:51] Michelle: Just measurements or the intervention was.
[28:54] Chris: The intervention was measurements,
[28:57] questions, whatever.
[28:59] And this course was done down in the American south, you know, in Alabama.
[29:05] So the question was, again, what happens to untreated syphilis long term?
[29:10] And, you know, as it turns out,
[29:13] you know, people of all races and genders get syphilis.
[29:18] But the only people who were studied in this study were black men.
and the, the big crime was that. Well, the first big crime was studying only black men when the disease belongs to everyone.
[29:32] But the, but the big crime was,
[29:34] you know, that the 40 year longitudinal study didn't wrap up till the 1970s,
[29:40] actually beyond the point where curative treatment was available for the disease,
[29:47] but wasn't offered to those people in the study.
[29:51] So the issue of fairness hinges on equal treatment of people in whom the phenomenon is distributed.
[30:02] So fairness and then beneficence is the second leg of the Belmont report. And that means that, you know,
[30:10] It's not enough really just to study something for the sake of studying it.
[30:17] Right. We ought to try to do good for the subject.
[30:21] Right? Study something that is going to help either them or help somebody else. Because oftentimes you can't help the subject directly, but you can learn something to help future subjects.
[30:33] right. So fairness, beneficent, beneficence, and then what they called at that time respect for persons.
[30:40] And in respect for persons, we find autonomy and we find informed consent and we find, you know, the absence of coercion.
[30:51] And so one of the things that's different about research than,
[30:56] than treatment, for example,
[30:58] you know, is we can actually force people to get treated.
[31:01] Right? There's actually legal ways we can force people to take,
[31:05] you know, psychiatric medication or tuberculosis medication.
[31:10] We can't force somebody to be in a research study no matter how benign the study is.
[31:16] Right? So, and that's just again, you know, because there historically had been a lot of,
[31:22] you know, wrongs labeled as research. Like the Tuskegee one is a familiar example because it was actually labeled as research.
[31:34] Right, but these go back farther than that. And they go back,
[31:38] you know,
[31:38] importantly to the Nazi medical experiments. Right. Which weren't really,
[31:46] you know, framed so much as research.
[31:50] but they technically would meet the definition,
[31:54] although certainly would never be approved by an ethics board, we hope.
[31:58] Michelle: No.
[31:59] Chris: Right. But these are, you know, things that,
[32:01] you know, the belligerence on the, in the axis of the,
[32:08] of the Second World War had legitimate reason to want to know. You know, I mean, if a German ship went down in the Baltic Sea in winter and the water's 42 degrees,
[32:19] they want to know how long they should send people out risking their lives looking for survivors.
[32:24] And they, they wanted a measurement to know that after a certain amount of minutes, it's futile you come back in. And the way they would do that is to,
[32:34] you know, round up undesirable persons that they had a lot of back then,
[32:39] and they would just put those people in 42 degree water about 30 at a time.
[32:44] Because 30 is taken to be the cut off between a small number and a large number. And it's where you can establish a curve, you know, a normal curve or a bell curve.
[32:55] And they would just stopwatch these people and, you know, count how many minutes it takes for each one to die.
[33:02] And then they calculate an average and add two standard deviations to it and say, that's the number of minutes we look for people.
[33:10] Michelle: Wow.
[33:11] Chris: And, you know, and actually those data actually still used today,
[33:15] you know, when the Coast Guard's out looking for a fishing boat that sank in Nova Scotia in the winter.
[33:22] Right. But we had to get rid of that kind of research.
[33:25] Michelle: Yeah. Not good.
[33:26] Chris: Yeah. So that was why Boards got established. Now,
[33:32] another misconception about the IRB is they have to look at everything you do.
[33:37] No, they don't. They only have to look at human subjects research. If it doesn't fit the definition of human subjects research,
[33:45] they don't have to examine it. Right.
[33:48] So, for example, there's a lot of research done by clinicians that doesn't qualify as human subjects research.
[33:56] Most retrospective research,
[33:59] where you go to the medical record and you go to your HIM department or your IT department, you say,
[34:07] pull me the three years of patients who came in with this diagnosis,
[34:14] had this drug,
[34:16] and died within 30 days of admission.
[34:20] And don't give me any identifiers,
[34:23] all I want to know is their age,
[34:25] gender,
[34:26] race,
[34:27] source of admission,
[34:29] height, weight, whatever.
[34:30] Michelle: So you're just looking at data.
[34:32] Chris: So if you're looking at de-identified data, not identifiable data don't need IRB approval.
[34:38] Michelle: Okay.
[34:39] Chris: If you get your data from a publicly reported data source where it's de-identified,
[34:45] like CDC, like CDP8,
[34:47] where you can go and download big data sets about millions of patients at a time.
[34:53] Michelle: Don't need it.
[34:53] Chris: Don't need it. If you're going to do secondary research like top of the pyramid systematic reviews,
[35:01] where your unit of analysis are other published studies.
[35:05] So I'm going to look at 20 studies published and you know,
[35:10] meld them all together and make one result out of it.
[35:13] Chris: And see if it favors this or that. That's not human subject research.
[35:18] Chris: Quality improvement.
[35:20] Chris: You know, doesn't need IRB approval.
[35:22] Michelle: That's a good distinction.
[35:23] Chris: But the IRB members have to take about 30 hours of courses,
[35:30] so they have to get deep into all the ethics and all the data protection and all the consenting and the pediatrics and the vulnerable subjects that require special treatment by the investigator.
[35:46] Right. So if you're studying a 10 year old,
[35:48] we've studied 10 year olds,
[35:51] we studied just recently 10 to 17 year olds in a research study in my organization.
[35:57] And so when you study a 10 to 17 year old, the board has to decide how are we going to handle that respect for persons with them with a 10 year old.
[36:10] And that depends on how much risk there is. And
[36:15] they specify four levels of risk that you can do to a kid.
[36:21] Right. Like the lowest level is asking them a question or measuring their weight or something like that.
[36:27] The highest level would be,
[36:28] you know, doing a painful baboon heart transplant as a study.
[36:34] Michelle: Making them wear a mask when they're too young.
[36:36] Chris: Something like that. Right.
[36:38] And so, you know, with an adult,
[36:40] when you, for example, sit down with them and you ask them to play a computer game to test some aspect of their cognition.
[36:50] Right.
[36:51] Maybe all you need is a verbal consent.
[36:54] You don't need to document it anywhere,
[36:56] say. Okay,
[36:57] Michelle, I'd like you to take this five minute computer game thing. I want to see where you score.
[37:03] You okay doing it? I don't think there's any risk to you other than you might get all excited and buy more computer games.
[37:09] Michelle: Well, as a side note, you might remember the study that was done at our institution during COVID and it was exactly what you're talking about.
[37:21] It was done by the psychiatric residents and it was measuring.
[37:29] Well, I guess they didn't know. Well, they did know if we had Covid because we had to say if we had, if we had had a history of COVID and how it affected our cognition.
[37:42] And so we did have to play certain games, do certain puzzles,
[37:47] stuff like that, for a period of six months.
[37:51] So I went every two months for six months.
[37:54] Chris: Yes, I remember that study very well.
[37:57] Chris: The research question was something like,
[38:00] you know, in adults who are tested with X, Y and Z tests,
[38:07] will there be a significant difference in cognitive function as a, as a function of having had Covid or never having had Covid?
[38:18] Michelle: And I was in the group that never had Covid, and I still have never had Covid. And I always knock on wood.
[38:25] Chris: Yeah. And that study actually was designed to be a two year study and we had to close it early.
[38:32] And the reason we closed it early is we ran out of people who'd never had Covid. Oh, right. So every time we bring a subject back,
[38:41] we would ask them if they had Covid and they say yes.
[38:44] So those are called crossovers in a clinical study.
[38:49] Chris: And so people crossed over from group A to group B. We ran out of group A people.
[38:55] Chris: So we, we, we quit the study early and actually we found no differences in cognition between the infected or never infected group.
[39:05] I could tell. And, and I could tell you there are probably differences while you're suffering from the acute infection. Yeah, yeah. But once you get over it, then it's like, you know,
[39:16] not a big deal.
[39:16] Michelle: Yeah.
[39:17] Chris: So you go to the IRB with your,
[39:20] with your research question and you've turned it into a plan to do a research study.
[39:26] And this is where I mentioned that, you know, before AI, we used to give people the seven page template and they have to address the 19 aspects in the protocol.
[39:38] You know, what is your research question?
[39:41] Give me some background. Has this ever been done before?
[39:46] Because we want to know. Right. That way,
[39:48] the IRB's job, remember,
[39:52] is to evaluate the ethics of the study and protect the human subjects. Right. So what they want to know is what is the level of risk to the human subject?
[40:05] Right. So, and there's two classes of risk.
[40:08] There is more than minimal risk,
[40:12] and there is minimal or less.
[40:15] Less than min.
[40:17] Not more than minimal risk.
[40:19] Those are the non minimal risk.
[40:22] Michelle: No.
[40:23] Chris: Yeah. Not more than minimal risk, and then more than minimal risk. So this is the government terminology.
[40:30] Michelle: Yeah, it seems very gray.
[40:32] Chris: Right. And so it is recognized, however, if you look at those two terms side by side, more than. Not more than minimal risk. There's no category for riskless.
[40:46] Michelle: Right? No risk.
[40:47] Chris: There's no such thing as a no risk study. Right. So in human subjects research.
[40:55] Chris: In non human subjects research, which we use that word,
[41:01] there can be riskless because there's no risk to a human.
[41:05] Right. So in human subjects research, there's always at least the risk of exposure of protected health information.
[41:13] Okay. And that in retrospective or using retrospective studies or maybe survey research,
[41:22] you know, where you're just asking people their opinion on why do you think, you know,
[41:27] healthcare workers don't take the COVID vaccine.
[41:31] You know, I mean it's not a difficult question for them to answer.
[41:36] Michelle: It's not gonna, you know, harm anybody.
[41:38] Chris: Cause anyone to fire them if they know the answer.
[41:41] Michelle: Yeah.
[41:42] Chris: Now, if you want to ask a 10 year old about their experience of sexual abuse, that's probably more than minimal risk.
[41:51] Michelle: Yeah.
[41:52] Chris: They're gonna say, okay, well, you need to make sure that if that kid comes unglued during the session that you've got some way of.
[42:01] Taking care of them.
[42:03] So the board evaluates the risk and says,
[42:08] is the risk more than minimal or not more than minimal?
[42:14] And we allow risk to subjects,
[42:17] we even allow risk of life to subjects if all those other conditions are met. The fairness,
[42:24] the respect for persons, the beneficence.
[42:27] Right. So we allow investigators, like drug trials,
[42:30] do things to you, as long as you consent to it. The full information.
[42:36] Yes, I'll take the pig heart transplant.
[42:39] Well, here's what we think has happened in the past.
[42:42] Here's the introduction. Right.
[42:44] This has been done 75 times in the history of the world.
[42:48] The mean survival has been 12 days.
[42:52] We have one guy that lived three months in a coma in the ICU,
[42:57] you know, so sign here,
[43:03] So we can handle any level of risk,
[43:07] even the most risky procedures or drugs or whatever,
[43:11] if the risk is balanced and the risk is reasonable, given where the subject is right now, most,
[43:23] most nurses, most nursing research is probably going to be not more than minimal risk.
[43:29] Michelle: Yeah, Right.
[43:30] Chris: Because nursing interventions, absent advanced practice, nursing interventions are generally low risk interventions. Right. I mean, medication administration can be high risk.
[43:44] Michelle: Sure.
[43:45] Chris: Right. So that, that might be an outlier. There may be some other treatments or something like that. But your job as a researcher is to write your plan and cover those 19 elements.
[43:58] Has it ever been done before?
[44:00] What do you expect to happen?
[44:03] Where are the data?
[44:04] How will you collect them? What variables exactly are you going to collect?
[44:11] Where are you going to store those data so that they don't get exposed?
[44:17] How are you going to explain this to the human subject?
[44:21] What does your consent look like?
[44:24] Is there a conflict of interest anywhere? Are you going to make any money off this? And then there's some federally required categories that have to be answered on every research study.
[44:35] If I'm asking you about how you feel about your job,
[44:38] is this an HIV study?
[44:41] Right. That's worked into the federal,
[44:43] you know, stuff.
[44:45] Is this a Department of Defense study?
[44:48] Michelle: Yeah. Do you have to state a time period that your study is going to take place?
[44:53] Chris: Okay, yes. You have to say exactly when it's going to start,
[44:56] exactly when it's going to stop.
[44:58] And the IRB then will evaluate the right and wrong, the ethics of this study according to risk and how you've mitigated or balanced it and what the human subject, like I said, they can agree to any level of risk they want,
[45:15] but it has to be done ethically.
[45:18] So if you get a homeless guy off the street, you say, I want to try this pig kidney transplant.
[45:27] I see you're in renal failure.
[45:29] I'll give you a hundred thousand dollars to participate in the study.
[45:32] Michelle: Not ethical.
[45:34] Chris: They might say yes. Right, right.
[45:36] You know,
[45:38] so the, the enticement or the incentive can't be disproportional. Can't be something everyone would say yes to, no matter the risk. Right, right. That kind of thing.
[45:51] And so you've put together your protocol. You're put it in front of the IRB and their job, really. We. There's a Bible we use.
[46:00] It's a tiny little Bible. It's about half this big.
[46:04] It's the size of a little poetry paperback,
[46:08] and it's 99 on eBay. Tiny little book.
[46:11] And it's Institutional Review Board Robert J. Amder.
[46:18] Right. So this guy makes a ton of money, right, in this little tiny book, and he's the only one that does.
[46:22] Michelle: And what's in the book?
[46:24] Chris: How to run an IRB, how to be an IRB Member. And it's a really good book. I actually have some older versions. I could give you one.
[46:32] Chris: But on page five. And I always explain this to new IRB members because IRB members, people always, you know, when you put a authority badge on them.
[46:41] Oh, man. Now they want to use that thing.
[46:43] Michelle: Yeah, right.
[46:44] Chris: So their job is to look at risk and mitigation.
[46:50] And some of them are good. They want to, they stay to that.
[46:53] Some of them want to look at spelling.
[46:56] They want to look at,
[46:57] you know, I mean, they want to look at this, the statistical analysis plan.
[47:04] And they say that's not the appropriate,
[47:06] you know, statistic. You haven't established, you know, normality and homoscedasticity of the data set.
[47:14] You have to use a non parametric statistic. It's Kruskal Wallace, not Wilcox. And rank sum.
[47:21] Okay, so. And that stuff doesn't matter. That's not the job of the IRB but sometimes they take that job on themselves.
[47:28] Michelle: Take it very seriously.
[47:29] Chris: So page five of that book of Amder says
[47:33] When approving, when you have a protocol in front of you. Okay.
[47:38] Read the protocol.
[47:39] If a change to the protocol will not result in meaningful improvement to the welfare of the human subject,
[47:51] approve the protocol as written.
[47:54] Michelle: So don't read into things.
[47:57] Chris: Don't try to change the spelling. Yeah, there and there. Don't fix that.
[48:01] Michelle: Right.
[48:03] Chris: Now if you can say that a change to the protocol will produce a meaningful improvement in the welfare of the subject,
[48:14] then you should not approve the protocol.
[48:17] And you should go back to the investigator and say we need a change. Make the change.
[48:24] And, and that's the way it works.
[48:26] And protocol, once it's approved,
[48:30] is good for a particular period of approval. And if you want to continue the study beyond that time,
[48:37] you have to submit a modification request.
[48:40] Modification. I want to extend the study for one more year. Why?
[48:45] I don't have enough subjects. Okay.
[48:48] I haven't had enough time to collect the data.
[48:51] I ran out of assistance or whatever.
[48:54] If you want to change anything about the protocol, you have to submit a modification request to the IRB.
[49:01] If you're doing a questionnaire,
[49:04] it has 75 questions on it about nurses intent to continue to be a nurse for the next 10 years.
[49:11] Okay.
[49:12] And you want to change one of those 75 questions,
[49:15] you have to submit a modification to the IRB.
[49:18] Michelle: Is this part of the reason why it takes, what is it, three to five years before we get that research?
[49:28] Chris: No. Well, that's part of it.
[49:30] Michelle: Okay.
[49:30] Chris: But the clock actually doesn't start there on the metric that you're talking about.
[49:35] I think the metric you're talking about is you know that when a piece of research gets published.
[49:41] Michelle: Yes, yes.
[49:42] Chris: You know, it takes 17 years for someone to pull it off the shelf and put it into practice or something like that. And it's probably a shorter time now.
[49:52] But, but you're right, there is a pre publication lag.
[49:58] So from the time that the PICO appears in your brain to the time you get the paper published.
[50:05] Depending. And that could be three, four, five years.
[50:08] Or it could be three, four, five months.
[50:10] Michelle: If you pay.
[50:11] Chris: Depends on if you pay. Because the money, green money makes the world go round.
[50:16] Michelle: That's right.
[50:16] Chris: So it depends on the complexity of your study. You know,
[50:20] if all you want to do is ask,
[50:23] nurses there how they feel about,
[50:26] you know, the potential passage of the Big Beautiful Bill by the Trump administration.
[50:32] And it's four questions.
[50:34] You know, you can get that done quick.
[50:36] Michelle: Yeah, good to know.
[50:37] Chris: But if you want to. But many studies are longitudinal. Right. We're doing a longitudinal study right now. It's a 10 year study.
[50:46] Michelle: So a longitudinal is over time.
[50:48] Chris: Over time.
[50:49] Michelle: Okay, Right.
[50:50] Chris: So we're doing a 10 year breast implant complication study.
[50:53] If your audience wants to look at the granddaddy of all longitudinal studies, they should look up a thing called the Framingham Study.
[51:04] Michelle: Okay.
[51:04] Chris: And the Framingham study would be of nurse of interest and you should include this probably in your resources.
[51:13] So the Framingham study is conducted in Framingham, Massachusetts. It's at suburb of Boston and it's in about its 80th year, I think.
[51:22] Michelle: And, and this isn't the nurses study.
[51:25] Chris: It's a heart disease and lifestyle study. Okay,
[51:35] Now that's a really good question and that's a really illustrative question.
[51:40] So the Framingham Study is in its
[51:44] Well, it was started in 1948,
[51:48] so it's going on about 80ish years old.
[51:52] Chris: And when you search for it, you will get a thing called the Framingham Nurses Study. It's not nursing research. The subjects are nurses.
[52:07] And it used to be called the Nurses Health Study.
[52:10] Chris: Later iterations. It's now called the Framingham Health Study. Okay, but it studies nurses originally and now, and then it studied their children and then it studied their children and then it studied their children.
[52:25] So it's into about fourth or fifth generation of subjects, beginning with those nurses. And we, we actually both knew a nurse in the Framingham Study.
[52:35] I knew her pretty well. I don't know if you ever knew her very well. She's,
[52:39] passed a few years ago, but her name was Lindeen Ward.
[52:43] She was an operating room nurse at our hospital.
[52:47] She was a subject in the Framingham Study. Okay, but this is a longitudinal study. It's intended to go in perpetuity. So a hundred years from now, God willing
[52:59] And it'll still be going.
[53:00] And it looks at, you know, they interview their subjects every two years.
[53:06] And every two years, the person. They don't have to come to Massachusetts.
[53:11] They can if they're local,
[53:12] but they take a survey and they submit blood work and they submit medical records.
[53:19] Michelle: So does a longitudinal study
[53:21] It doesn't have to have an end date?
[53:24] When, like, if you go before the IRB board, you or the IRB,
[53:30] you don't have to say, this is going for 10 years, 20 years. Or you can say.
[53:36] Chris: I think that's a good question. I'm actually not sure about that.
[53:40] Michelle: Okay.
[53:41] Chris: I think probably being the type of people most IRB members are, they would say, well, let's put a date on it.
[53:49] Michelle: Yeah.
[53:49] Chris: If it's 10 years in the future,
[53:51] and then at nine and a half,
[53:54] modify it, extend it for another 10 years. I don't know.
[53:58] You could probably find the protocol.
[54:00] Framingham study has its own website.
[54:03] No, no, it's on the website.
[54:05] Michelle: Okay.
[54:05] Chris: And there's been 500 papers published from the Framingham data. It's a correlational study. So it's observational. There's no direct intervention. They're not giving people medication.
[54:20] What they're studying is lifestyle and health.
[54:25] So they're correlating all the variables and they're saying, well,
[54:30] you know, these people lived to be 85 with no health problems,
[54:37] and here's what they did all their life.
[54:39] Right. They didn't smoke, they didn't drink,
[54:42] you know, whatever they had.
[54:44] Michelle: Those are very valuable studies.
[54:46] Chris: Yeah. Well, yes, they are. However, let's go back and look at the evidence pyramid.
[54:54] Michelle: But you can't replicate it.
[54:56] Chris: Well, you can replicate it. You just, you know, you're at about level four. A single observation, single correlational, observational study.
[55:07] Michelle: And that's on the pyramid.
[55:09] Chris: That's on the evidence pyramid. Evidence hierarchy.
[55:11] Michelle: Okay. So it's not towards the top, it's in the middle.
[55:14] Chris: Right. Why would. Why would that be.
[55:17] Michelle: Because it doesn't have.
[55:21] Chris: Why, why wouldn't that evidence from that study?
[55:26] Michelle: Because there's no intervention.
[55:29] Chris: Could be. Although observations can be pretty strong. Jumping out of a plane with no parachute versus a parachute, you're going to have pretty strong evidence on both sides.
[55:40] Michelle: Okay.
[55:41] Chris: But the reason is, you know, and you could figure this out very quickly if I gave you.
[55:46] Michelle: Doubtful.
[55:47] Chris: Two more minutes. But the issue is control of the subject environment.
[55:55] So, you know, you got people all across the country reporting in every two years,
[56:00] they're not going to remember everything that happened to them. They're not going to remember everything they did. They're not going to, you're not necessarily testing for air quality and water quality in their environment.
[56:13] You know, there are what they call confounding variables. They're unseen variables.
[56:20] There are things that happen to that person that you're not measuring.
[56:25] So the links between the things that you're observing as lifestyle and the outcomes that you're measuring are not as strong
[56:38] As they would be if you did not a interventional necessarily
[56:45] Michelle: Like pescatarians only or
[56:49] Chris: Yeah, well, I mean, you'd have to observe them eat all the food,
[56:54] you know, because they say, well, I eat a little meat and a lot of vegetables.
[57:00] But you don't. But you could walk in and watch, they could be eating In & Out.
[57:04] Right. So. Well,
[57:06] just the, the connection between,
[57:09] you know, between the independent variable and the dependent variable is not as strong.
[57:17] Right. So the connection between the cause and the effect is not as strong in a study like that, in a lifestyle study.
[57:27] Michelle: So after they get a group of results, like you said earlier,
[57:32] okay, these people live to be 85 and they did this,
[57:39] then they could,
[57:41] break it down and say, well,
[57:44] you, what did these 85 year olds eat? Or what did they,
[57:50] where did they live?
[57:52] Or so they could even subject. Okay, Right.
[57:56] Chris: So that's how the data are collected.
[57:58] Michelle: Okay.
[57:58] Chris: Right. And so we'll probably get toward ending with this then I think we'll talk about what we want to do in number three, maybe we want to get more technical.
[58:07] Michelle: Okay.
[58:08] Chris: But when we talk about,
[58:11] you know, ways to measure things, which we might talk about measurement and,
[58:16] you know, how we analyze the data and how we,
[58:20] how we publish the results,
[58:22] the publication dissemination process,
[58:25] putting things in journals,
[58:27] talking about things in podium presentations,
[58:30] making posters.
[58:31] Right. Maybe those type of things.
[58:33] Michelle: Yes.
[58:33] Chris: So if you just keep all your results under your own hat,
[58:36] then the world doesn't know about any of those things.
[58:39] Then you've inconvenienced your, your human subjects just for your own knowledge.
[58:43] Michelle: Right.
[58:43] Chris: And that's selfish. Right. We don't want to do that.
[58:46] So when we talk about ways to measure things, for example,
[58:49] you know, so we're the Framingham subjects, I mean, don't quote me on this, but you know, I'm guessing that we're gonna want their weight every two years. I'm sure we are.
[59:00] Right now how are we gonna get their weight? Are we gonna,
[59:04] you know, strip them completely naked?
[59:07] Michelle: You might just ask them and hope that they're honest.
[59:09] Chris: Exactly. Right. Now, so the most accurate weight.
[59:13] Right. Would be to bring them into a clinic and put a five ounce gown on each one.
[59:19] Right. Then back five ounces out of the weight. Okay, Right. And wage person with a validated and reliable instrument.
[59:27] Michelle: Yes, right.
[59:28] Chris: You know, but, but there's other ways. There's been studies done on this, three ways to measure people's weight. At least estimate it.
[59:38] This is the guy at the circus,
[59:40] you know, and he guesses your weight,
[59:43] guess my weight. And if he gets it right, you know, you get a quarter or whatever, you get a stuffed animal, he gets a quarter. I mean, whatever it is he gets to get, you know, so anyway, so you can estimate it.
[59:54] Right. Probably the least reliable way of doing it.
[59:57] Then you can have the subject state their weight.
[01:00:00] Right. You could use some kind of a,
[01:00:03] a recorded measure, like look at their driver's license.
[01:00:08] You know, that's an interesting way to measure
[01:00:09] Michelle: How many people lie on their driver's license?
[01:00:12] Chris: Or you can measure it directly.
[01:00:14] Michelle: Yeah, right.
[01:00:15] Chris: And so you want to choose the,
[01:00:17] method of measurement that's most accurate. Precise. Yeah, accurate and precise. Those mean two different things, right?
[01:00:25] So we always, when we're talking to people and training them in these methods, we say, for example, that there's a correlation, there's a U-shaped correlation,
[01:00:35] if you look at a X, Y right there,
[01:00:38] between depression and weight.
[01:00:41] So if you measure depression on your PHQ9 and you measure weight on the scale,
[01:00:47] people of very low weight have more depression,
[01:00:52] people of very high weight have more depression.
[01:00:55] People who are somewhere in the middle have the least depression.
[01:01:00] So you could, knowing that if you knew the standard deviations and the means of a large data set, you could estimate weight using the depression scale,
[01:01:13] or you could reverse it and estimate score on a phq9 as a function of their weight.
[01:01:19] But you wouldn't really want to do that because that's a very,
[01:01:22] again, a very sloppy connection.
[01:01:25] Michelle: Could you determine a person's depression level based on their weight?
[01:01:28] Chris: Yeah, that's what I just said.
[01:01:30] Michelle: Oh, okay.
[01:01:30] Chris: Yeah.
[01:01:32] So like if you know this, if you know this say this is, you know, 200 kilograms or this is 50 kilograms and this is 200 kilograms and the sweet spots at 100, let's just say.
[01:01:45] Michelle: Okay, right.
[01:01:47] Chris: And then these are for those of.
[01:01:49] Michelle: You that can't see this. Chris has drawn the curve.
[01:01:52] Chris: I've drawn a U-shaped curve.
[01:01:55] Okay. So then if you know this is it, then you bring a person in and they fall right here for weight. You can say, well, that that's correlated with a level of this on the phq9.
[01:02:08] So they're probably about this depressed. But again,
[01:02:11] that would be a very sloppy connection.
[01:02:14] Chris: Between the independent and dependent variable. So you wouldn't want to use that as a way to do it unless you had no other way of estimating weight.
[01:02:23] Michelle: Yeah. Okay.
[01:02:24] Chris: Right. So I think in the next
[01:02:28] Michelle: And hold on, before you say that.
[01:02:32] My message to anybody out there who wants to do research is, you know, the purpose of this whole thing that we're doing and let's take myself for example. Somebody who 20 years ago, even 10 years ago, didn't know very much about research.
[01:02:52] And I'm going to start a study.
[01:02:56] Where would I go if I didn't have somebody at my institution like a researcher?
[01:03:05] Who am I going to go to?
[01:03:07] Chris: Well, I can tell you exactly. Let me back up. One thing is first, the message is you can do it. Remember, any nurse at any level can do some meaningful nursing research.
[01:03:17] Michelle: Yes.
[01:03:18] Chris: And I'll tell you what I would do right now.
[01:03:20] And your listeners can practice this at home right now.
[01:03:24] Get on your chat GPT and say, I want to get started in nursing research.
[01:03:32] And here's the burning desire I have. Here's the thing I want to study and then start.
[01:03:37] Here's the chat part. In chat GPT when you ask it a question and give it an input, it's not just one and done.
[01:03:46] You are chatting with a machine being. If you want to use that oxymoron that knows everything about nursing research that it's gotten its hands on and it's gotten its hands on one.
[01:04:00] Michelle: And so you can continue, quote, chatting with it.
[01:04:03] Chris: I don't think I can do that. Can I do what's easier? What's easier? What's easier? What's quicker? What's quicker?
[01:04:10] Michelle: It's so different than just like Googling.
[01:04:13] Yeah. And people have to get used to that. And I do want you to do an episode on ChatGPT or AI, the.
[01:04:20] Chris: Use of it AI in nursing.
[01:04:23] Michelle: Okay. And so now next time, what are we going to talk about?
[01:04:27] Chris: So next time we'll get into a little bit about data collection and a little bit about data analysis.
[01:04:34] Michelle: Because our plan has been approved by the IRB now.
[01:04:38] Chris: Yes. And remember what the IRB really technically approves is data collection.
[01:04:43] Michelle: Okay.
[01:04:44] Chris: Because that's where the investigator interfaces with the subject.
[01:04:48] Michelle: Okay? So next time will be
[01:04:50] Chris: You got your data,
[01:04:52] so now what do you do? Right,
[01:04:54] so you have, you have question, you have data.
[01:04:57] And remember the research 30,000 foot view is answering a question with data.
[01:05:05] But usually you have to,
[01:05:07] torture the data a little bit to get it to tell you what you want it to tell you.
[01:05:14] Now if you torture it enough, it'll tell you whatever you want, but it will may not give you, you know, real answers,
[01:05:20] right? As with any type of torture.
[01:05:23] So we want to torture the data just enough to tell us,
[01:05:26] to give us the answer to our question.
[01:05:29] And then once we have the answer to our question,
[01:05:31] now we're talking about dissemination,
[01:05:34] right? So now we're saying how do we tell the world about this,
[01:05:38] Do we publish it in a paper?
[01:05:41] If so, how do we find the right journal?
[01:05:44] How do we write the manuscript?
[01:05:46] Are we going to take this on the road and get drug companies to pay for 45 minute events at the local Michelin star restaurant?
[01:05:56] Michelle: That sounds good.
[01:05:57] Chris: Are we going to go to poster or take it to
[01:05:59] Michelle: Yeah, like a poster presentation at a national conference.
[01:06:03] Chris: Yes.
[01:06:03] Michelle: Okay.
[01:06:04] Chris: Yeah, so we'll talk about dissemination. Okay, so I'll talk about data collection, data analysis, manuscript writing, publication dissemination, that kind of thing.
[01:06:14] Michelle: Okay, stay tuned.
