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On today’s podcast, we talk about how to evaluate clinical research and how it is actually carried out. We are currently in the midst of a free 30-day trial of the EBB Pro Membership, and this podcast episode is a sample part of a class series inside the membership!

Have you ever wondered how research is carried out, and why certain things are studied… but why other aspects of birth and midwifery care are not? Do you know how many billions of dollars are spent in the U.S. research industry each year, and what that money is spent on?

In this podcast, Dr. Dekker will walk you through the timeline of how research is carried out, who decides what research gets funded, and why so much research has come from a racist and patriarchal lens. You’ll also learn about the importance of one of the newest fields of science called “clinical and translational research.”

Note: If you want to watch the video with PowerPoint slides and screen-sharing, you can watch the podcast on our YouTube channel here!

Content Warning: We will be talking about racism and sexism in research, and how this has led to an increase in heart disease deaths among women. And I share a personal story related to heart disease and mortality.

Resources

Learn more about our Pro Membership here (https://evidencebasedbirth.com/become-pro-member/). 

 Learn more about biomedical translation here (https://www.youtube.com/watch?v=TnHLo-hCssg).  

 Learn more about the NIH Reporter here (https://reporter.nih.gov/). 

 Learn more about Eunice Kennedy Shriver NIH here (https://www.nichd.nih.gov/). 

Transcript

Rebecca Dekker:

Hi everyone. On today’s podcast, we’re going to talk about how research is actually carried out.

Rebecca Dekker:

Welcome to the Evidence Based Birth® Podcast. My name is Rebecca Dekker and I’m a nurse with my PhD and the founder of Evidence Based Birth®. Join me each week as we work together to get evidence-based information into the hands of families and professionals around the world. As a reminder, this information is not medical advice. See ebbirth.com/disclaimer, for more details.

Rebecca Dekker:

Hi, everyone. Welcome to this week’s episode of the Evidence Based Birth® Podcast. Today, I have a special treat in store for you. I’m going to be sharing with you an excerpt from a class I teach for our Evidence Based Birth® professional members, all about how to evaluate clinical research. At Evidence Based Birth®, we have more than 1,000 professionals from across the world who get their continuing education from us. Their memberships support the work we do at EBB, and we are thrilled to always be giving them access to cutting-edge continuing education classes.

Rebecca Dekker:

One of the classes that I taught last year to our members was a four-week class all about how to evaluate clinical research. We actually dove into how research is carried out. What are the different components of a research study? And how do you critically evaluate a research study to see if it can be applied to your situation?

Rebecca Dekker:

We are in the midst of a free trial to our professional membership where you can go to evidencebasedbirth.com/membership and sign up to get a free 30-day trial of all of our continuing education resources for professionals. I wanted to share with you this excerpt from this class that I taught so you can get a taste of what it’s like to be an Evidence Based Birth® professional member. So in this podcast, you’re going to be listening to about 40 minutes of a one-hour class. That was the first class out of four total that we taught about how to evaluate research. At the end of this podcast, if you want to learn more and finish taking this class, just go to evidencebasedbirth.com/membership and sign up for the free 30-day trial. And this class is archived in our monthly live training library.

Rebecca Dekker:

Just a quick heads up before we get started, we will be talking about racism and sexism in research, and how this has led to an increase in heart disease deaths among women. And I share a personal story related to heart disease and mortality.

Rebecca Dekker:

Everyone, welcome to the first session of a series all about evaluating clinical research. So go ahead and tell us where you’re joining from in the chatbox. And after you share where you’re joining from, I’d love to hear if any of you have personal experience in research. What’s the extent of your research education? Did you take a statistics class at some point, or have you gotten a degree in a field that gave you training and research? I’d love to know what your background is for those people. And if you have zero experience with research, don’t be afraid to say that as well. And we got people joining from all over the world. We’ve got people from the U.S., Canada, Texas, California, Louisiana, California, Maryland, Vermont, Tennessee, Colorado.

Rebecca Dekker:

We’ve got some people are saying no real experience in research. About 10% zero people who’ve read from the instructor training if they became Evidence Based Birth® instructors, what they’ve picked up as a doula, what was covered in nursing school.

Rebecca Dekker:

So if you are new to research, you are not alone. But I also know that we’ll probably have some people here, like Amy who’s joining who got a master’s in education, had research in statistics. So I figured we’d have a range of experience levels, and that is totally fine. And we’ll get started. All right, looks good. We’re ready to go.

Rebecca Dekker:

I’m so excited for this series. I have thought really long and hard about what we should cover. And what I decided to do, I’m going to start off with what we’re going to cover in part one or session one. And then in session two, we’ll move on to evaluating some actual studies that are observational. And then in session three, we’ll evaluate some randomized trials. And then we’ll leave session four for anything else we haven’t covered yet and any questions you may have. Also, the questions you ask today may inform how the future sessions go. So if there’s something I don’t cover today, I’ll be able to add it to the future sessions.

Rebecca Dekker:

So evaluating clinical research. By the end of today’s session, you’ll be able to define clinical research and translational research, discuss how clinical research is funded and carried out, and describe some basic aspects of research methodology. Today, we’re going to talk about the research question, hypotheses, and design.

Rebecca Dekker:

So I’m super excited for this first session because I get to cover the behind-the-scenes of how research is done. In particular, how it’s funded I think is very important. I think you’re going to find it very enlightening.

Rebecca Dekker:

So what is clinical research? Clinical research is a type of research that’s intended to produce knowledge and help understand human disease, to prevent and treat illness, and to promote health. There are several subsets of clinical research, which include epidemiology. Epidemiology is when you’re improving the understanding of disease by studying patterns, causes, and effects of health and disease in different groups.

Rebecca Dekker:

Behavioral research improves our understanding of human behavior and how it relates to health and illness. There’s health services research, which looks at how people access healthcare providers and healthcare services, how much care cost, and what happens to patients as a result of the care they receive. And then often, we are talking about clinical trials. That’s a type of clinical research which evaluates the effects of an intervention on health outcomes.

Rebecca Dekker:

And when we use the word intervention research, I know sometimes that word may have negative connotations in birth work. But an intervention in research is basically any time you’re intervening with a human or interacting with a human could be an interaction, or an intervention. So it could be something like providing emotional support. That could be considered an intervention in a research study.

Rebecca Dekker:

So simply put, clinical research involves people. Here is a photo of someone in labor who has been eating waffles. And something with ketchup, maybe hashbrowns. And I see some syrup there. So clinical research in this situation could be studying the effects of eating food and what type of food you eat during labor.

Rebecca Dekker:

But in general, clinical research is anything involving actual human beings. This is different from basic research and animal research, which is focused on either laboratory. You think of Petri dishes, that sort of thing is basic research. And then you have animal research. And then we have clinical research. So whenever you see the word clinical research, you got to think we’re talking about people.

Rebecca Dekker:

So some examples of things we could do with clinical research. We could look at new medications. We may be looking at the safety and effectiveness of a medication. We may be looking at new surgical methods or new devices that can be implanted in people. We may be looking at new ways to use already existing treatments. And you could think of a medication that’s already being used for something else is now being studied for a new condition. For example, looking at hydroxychloroquine, which has been used for many, many years for other conditions, and then research on using it, looking at COVID. So that’s an example of clinical research.

Rebecca Dekker:

We can also do clinical research to look at new ways to change health behaviors. This is often understudied. A lot of the money in funding goes towards studying medications and surgical interventions. When health behavior interventions are just as important, if not more important when you consider that many of the health conditions that humans have are directly related to our behavior. And if we can change our health behaviors, we can change our health.

Rebecca Dekker:

And then also looking at new ways to improve quality of life. Unfortunately, in the past, a lot of medical clinical research that’s done by medical doctors was not really focused on quality of life. They were more focused on what they would call hard outcomes. But nurses in particular are the researchers who are really engaged and have been for a really long time in quality of life. It’s not just about quantity or years of life, but what is your quality of life? And that’s very important part of nursing clinical research.

Rebecca Dekker:

I want to give you all some caveats. When we’re talking about research, studying people is going to be messy. That’s because as we all know, people are not predictable or controllable. Although some people may be predictable. Human behavior is just messy. It’s not like we can do an experiment in a lab, and we know it’s going to turn out an exact way every time. When you do an experiment on human subjects or human beings, you get different results depending on the individual person’s reaction. So studying people can get kind of messy. It’s not a strictly controllable experiment when you’re dealing with human people and studying them.

Rebecca Dekker:

Also, research has been referred to as a research industrial complex, just like hospitals have been referred to the medical industry complex. And research is inherently racist and patriarchal, unless the person doing the research is taking active steps to work against this. And I will say that it is an industrial complex. We’re going to talk more about it in a minute. And it has been in the past designed to serve primarily white men. That was what the whole engine of research was doing for hundreds of years. And we’re going to talk a little bit more about who gets funding, and what is funded. And you’ll see what I’m talking about.

Rebecca Dekker:

Also, funding matters. Who is paying for the study? You can think about the years and years of ‘research’ that came out, showing that no, cigarettes don’t cause cancer. They have no relationship with cancer. And you go look at who funded those studies, and surprise surprise. It was the cigarette companies. We have a long history of knowing that who the funding comes from matters.

Rebecca Dekker:

Also, what is funded matters. There are huge areas of importance to maternal health that have almost zero funding. $0 given to them. And this is a huge problem because the people in charge of this industrial complex decide what gets the research dollars. And if you don’t have representation at the top of those people who are making these decisions, you’re not going to have research being done that affects what you and I are really serious about with maternal health. And we’ll talk more about that in a minute.

Rebecca Dekker:

Also, representation matters. So many studies in the past for a really, really long time were only done on white men. And in fact, I don’t know if you know this, but I learned this when I got to graduate school. The reason that so many women died of heart disease over the past half-century or so was because for about 50 years, the researchers and doctors thought that the only signs of a heart attack were crushing, excruciating chest pain, and jaw pain, and arm pain. Those were the classic symptoms of a heart attack that were taught to every medical student.

Rebecca Dekker:

The reason that doctors believe that is because researchers had only studied heart disease in men. And they specifically excluded women from all of these studies on heart disease. Because, they believed that women were too unpredictable and uncontrollable because we have hormones and we’re constantly shifting through hormones and going through menopause, and that sort of thing, getting pregnant, what have you. So they decided specifically that all these studies would only include men. Women were excluded. And for decades, the only research on symptoms of heart disease was done on men.

Rebecca Dekker:

In the meantime, women were dying in droves from heart disease. My own grandmother died of a massive heart attack in 1992. She had classic symptoms of female heart disease, which was shortness of breath and fatigue. And she had been ignored for years leading up to her heart attack. Nobody knew she had heart disease. She did have high blood pressure, and she was probably prediabetic. And she never got a chance to treat her heart disease because the symptoms were ignored until she had a massive heart attack and died. And that was directly related to the fact that women were not represented in these studies.

Rebecca Dekker:

So when we think about research, we can think about who was represented in this study. And a large part as a result of this big catastrophe with women’s heart disease, the National Institutes of Health, I can’t remember what year it was, but it was way too recent. Mandated that any research study that was being funded had to include women, unless there was a specific reason it couldn’t, like if it was a prostate cancer study or something. But they did change the rules. And now we have lots of research on heart disease in females.

Rebecca Dekker:

So clinical researcher is considered part of translational science. And translational science is any research that bridges the gap from bench to bedside. You often hear that term from bench to bedside. Bench means a laboratory bench, like where they set up a table with microscopes and all of that. And they’re doing all of this research in the laboratory. That’s the bench. The bedside is considered hospital bedside. And we know that there is a lot of research that is not being applied necessarily to humans, that there’s this huge industrial complex studying things supposedly for human health that never actually go on to affect humans.

Rebecca Dekker:

So I’m curious if any of you knew that about heart disease and why so many women died of heart disease. It wasn’t until there was a huge public campaign about 15 years ago to try and educate people about the symptoms of women’s heart disease. So it used to be if you came into the emergency room and you had shortness of breath and fatigue, or some other symptom, dizziness, they would just say, “It’s just nerves.”

Rebecca Dekker:

For our podcast listeners, at this point in the class, I paused my teaching and showed our class a video from YouTube, which I’ll post the link in the show notes, all about translational science. The video explains how translational science is necessary because it takes too long for scientific discoveries and costs too much to reach actual people. For example, most drug discovery efforts take too long, are way too expensive. And most drugs in development fail to reach patients. There are thousands of diseases that human beings can suffer from, but we only have known treatments for about 500 diseases.

Rebecca Dekker:

So translational science is a fairly new discipline in which researchers and other team members focus on discovery, development, and dissemination of research findings, so that we can turn research into something that actually has an impact on people’s lives.

Rebecca Dekker:

People who work in translational science are from many different fields. For example, you could be a biologist, a chemist, a computer scientist, a public health person, a physician, a nurse, or a data miner. Translational science is a team effort when these people invested in getting research to patients are patient-focused, interested in innovation, solutions, and systemic change. And I’ll make sure to link to that video that kind of animates that whole process in our show notes.

Rebecca Dekker:

Okay. So I was curious if any of you had heard of translational science before. Had heard of that term. A lot of nos? Okay. As they mention at the end of that video, it is the youngest field of science. I was lucky enough to get grant funding, we talk about research funding, to take a two-year certificate program to become certified in clinical and translational science. And it was a two-year post-graduate programs. So I took a lot of classes in translational science with people from all different fields.

Rebecca Dekker:

And essentially, the thought is that we all know about the evidence-practice gap, how long it takes to get research into practice. The thought is it creating these interprofessional, interdisciplinary teams that are focused on bringing research all the way across the spectrum too so they can actually be used with humans is what we need to be focusing on.

Rebecca Dekker:

Here is a depiction of translational science from the National Center for Advancing Translational Sciences in the United States. Basically this shows the translational science spectrum, each of those little circles. So it’s important to see this is a new paradigm. This is a new way of thinking about it. Used to think that scientific inquiry was a linear process. That you went from the laboratory to studying it in animals, to studying it in humans, to then disseminating it at conferences, to then doctors using it in their clinics.

Rebecca Dekker:

But now we know it’s not necessarily a linear process. Instead, it should be patient-centered. Patients should be a part of this involved in directing all of this. And each stage builds upon and informs the others.

Rebecca Dekker:

So you can see here that those doing clinical researcher are involved with the public health sphere, who were then informing them of what they’re seeing in the preclinical research, in the clinical research. The doctors, and nurses, and midwives who are implementing things or communicating with everybody. So it’s kind of a constant feedback loop.

Rebecca Dekker:

You’ll see that basic research is purple. That’s because basic research, that’s what we call laboratory research, is not part of the translational science spectrum. It is however informed by the other stages in the network. So maybe perhaps some clinicians are saying, “Hey, we’re seeing this. Could you all in the laboratory consider investigating this?”

Rebecca Dekker:

Preclinical research is another word for animal research. So that’s kind of a new term for animal research. Clinical research, you all remember what that is. Whenever you see the word clinical research, what does that mean? What should pop into your head? Who are we doing research on with clinical research? Humans, exactly. People.

Rebecca Dekker:

And then clinical implementation is when you’re adopting interventions. You may also be asking new questions. Identifying gaps in care, evaluating changes in how care has been delivered. And then public health, they’re studying health outcomes at the population level. So this is kind of what it should look like translational sciences. Developing new approaches, demonstrating the usefulness, disseminating the findings. And it’s all kind of like this constant feedback loop.

Rebecca Dekker:

So obviously translational science is important. Because if it’s not translational, it basically means it’s not being used. So translational science, another way to think of it is translational science is research that actually will help us as people. If it’s not translational, then it’s not really going to have any effect on our health or lives.

Rebecca Dekker:

So obviously, we need more research that has a translational focus. In a recent study in 2018, Han et al analyzed nearly 6,400 R01 behavioral and social science research awards. And R01, it’s R01, but it’s often called R01, is one of the top-level fundings. It’s considered the gold standard. If you’re a professor, your goal is to get an R01 grant. Once you have that, they’re usually multimillion-dollar grants that make your career. So those are the top, this is what researchers want to get.

Rebecca Dekker:

They evaluated all of these granted by the NIH from 2008 to 2014 that had to do with behavioral and social science. And then the researchers downloaded nearly 30,000 distinct publications that were published as a direct result of these grants. They found that only 6% of all publications were translational. They had kind of a distinct way of determining whether or not a publication was translational. So a research study was considered to be translational if there was a translational publication.

Rebecca Dekker:

They were more likely to be translational if they weren’t ‘basic research.’ But still, the highest percentage of these studies, maybe 14% were translational. Meaning the vast majority of studies being published as a result of this funding were not actually going to have an impact on human lives, even though that was the point.

Rebecca Dekker:

So I was going to ask you to guess the budget of the NIH. I forgot. I asked my Dan, my husband yesterday. “How much do you think the National Institutes of Health in U.S. spends on research annually?” He was guessing I think 400 million. I said 41.7 billion annually is spent in the United States on medical research. This is an enormous budget. It actually has been going up slightly under the Trump administration. For many years, it was a decline. And when I was working as a researcher, all the researchers were constantly fretting about how the research funding was declining.

Rebecca Dekker:

More than 80% of this goes to extramural research. And extramural research means it’s not part of the institute. So it’s given out via about 50,000 competitive grants to more than 2,500 universities, medical schools, and other research institutions. So that money goes to fund research and training of researchers.

Rebecca Dekker:

More than half of the extramural budget goes to support basic laboratory research. And another huge chunk goes to support what I call preclinical or animal research. So actually a pretty small part of the budget is going to human research. About 10% of the NIH’s budget goes to support projects in its own laboratories in Maryland.

Rebecca Dekker:

There are a variety of institutes that make up the National Institutes of Health. So the National Institutes of Health is kind of like the umbrella organization. And then there are dozens of smaller institutes that are kind of like subsets of the NIH.

Rebecca Dekker:

For obstetrics, the main funding institute is the Eunice Kennedy Shriver National Institute of Child Health and Human Development. I find it fascinating that there is no institute dedicated to women’s health. Instead, women’s reproductive health falls under child health and human development. Which just goes to show you back when the National Institutes of Health was set up and developed, how much emphasis, or care, or value did they place on maternal health and women’s health? Do you think they placed a lot on it or not?

Rebecca Dekker:

I’m going to stop sharing my screen here. And we will look at the Eunice Kennedy Shriver Institute. Probably not much because they saw women’s health as a subset of child health.

Rebecca Dekker:

I want to go to the NICHD, the National Institute of Child Health and Development, so you can see. And the reason I’m focusing on the U.S., I know we have people from other countries here. The vast majority of medical research is done in the United States. It’s where most is done. Let me pull up this link real quick. We’ll look at this together.

Rebecca Dekker:

So here we’re in NIH. And we’re in the subset of NIH that’s called the Eunice Kennedy Shriver National Institute of Child Health and Human Development. So their tagline is healthy pregnancies, healthy children, healthy and optimal lives. And again, they talk about women in terms of their pregnancy. Women are a pregnancy.

Rebecca Dekker:

You can see what they fund research in. Areas relevant to normal and abnormal human development including contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, childhood development through adolescence, intellectual and developmental disabilities, and rehabilitation medicine. And then if you look down, they list their priorities in terms of what are they funding? So they have high priority research areas for each branch and low priority research areas. So again, women’s health is competing for a limited number of dollars alongside the entire realm of children and adolescent health. We’ve got things like bilingual, biliteracy development, factors that impact infant and child development, psychosocial, school readiness, learning disabilities, reasoning. And then we’ve got some high priority research areas on contraception about preventing fertility, preventing sexually transmitted infections, looking at potential contraceptive targets. A lot of this is going to be laboratory research rather than human subjects.

Rebecca Dekker:

There’s a developmental biology and structural variation branch all about embryonic development. Here are high-priority areas. There’s a fertility and infertility branch. Notice what they have yet to discuss. We haven’t even gotten to actual maternal health. They’re more thinking about contraception, fertility, infertility.

Rebecca Dekker:

And then we get to gynecologic health and disease. A lot of this is genetic research looks like what they’re funding. The genetic underpinnings of gynecologic diseases. Then there’s a whole nother branch on intellectual and developmental disabilities for children and adolescents. And then there’s a whole lot of research on HIV being done. And then we finally get to, here’s obstetric and pediatric pharmacology. So these are medications in peds and OB. Safety of medications in pregnant teenagers is one thing, pediatric growth and nutrition, pediatric trauma and critical illness, more use about contraception. And then finally, we get down to pregnancy perinatology, improving the health of women before, during, after pregnancy, during pregnancy outcomes. Looking at SIDS, diabetes, neonatal pain, global perinatal health, placental biology, health disparities in preterm birth.

Rebecca Dekker:

So this is just one small section of a large institute. And this is the only focus you can find anywhere in all of those many institutes where it’s focusing on pregnancy.

Rebecca Dekker:

So one other option you could consider if you were a researcher looking for funding is the National Institute of Nursing Research or NINR. And that is the other institute that perhaps a nurse or a midwife would apply for funding for. Because I will tell you if you are a nurse or midwife, and you want to get research funding from the Eunice Kennedy Shriver Institute, who do you think that they’re more likely to fund? An OB/GYN, or a nurse or midwife? Yeah, so OBs. So it’s very hard for midwives to get funding from this branch, even though this is the branch that is supposed to be providing funding for pregnancy.

Rebecca Dekker:

You may be more likely to get funding from the National Institute of Nursing Research. But again, then you’re competing against nurses from every other branch of ranging from cardiovascular, to neurological, to care of the elderly. So very, very hard for somebody who’s interested in nursing who’s a nurse or a midwife to get research funding from the National Institutes of Health to study maternal health.

Rebecca Dekker:

The next thing I wanted to show you is something called the NIH RePORTER. Because again, I want you to understand the big picture of where research comes from, because we don’t get research without money. The NIH RePORTER, you can just simply Google NIH report or reporter, and you will get this search tool. And there’s a way to search by investigator name, by where the research is being done. You can search for specific keywords for funding. And somebody talked about who’s making the decisions? The people making the decisions are something called the study sections. So these are the study sections. They’re generally made up of a panel of the top researchers in their field in that specific area of medicine. So there is a pregnancy and neonatology study section. So somebody asks, “Who’s making the decisions?” So let’s look and see who’s there. Usually you can see their names. And you can see the list of reviewers, the membership panel, the topics. So here is the list of the members. And you can see the type of specialty. These are the people making decisions about anything related to a pregnancy research grant.

Rebecca Dekker:

You’re probably going to see a lot of MDs in departments of obstetrics and gynecology or pediatrics. You’re probably not going to see many RNs. We can check. I’ll check RN. Let’s see. I don’t know if I see any RNs. No nurse. No midwives. So these are the people making the decisions.

Rebecca Dekker:

Now it may be that if you are a nurse or midwife and you submit a research grant, maybe it would go to the nursing section study section, which then might be more likely to have nurses evaluating the study. So that’s just a quick, all of this information is publicly available. Because it’s all paid for with taxpayer dollars from the United States.

Rebecca Dekker:

So one thing I wanted to show you is just kind of browse. We talked about the Eunice Kennedy Shriver Child and Health Development Institute. You can see here’s their budget. Their budget is $1.7 billion. And they currently have 3,691 projects going on. You can click on this, and you can see where the projects are being done, how much they’re paying for each project. Here’s an interesting one. Source of the placental microbiome. See if there’s any other ones related to pregnancy. Breast milk, microbiota influence on infant immunity and growth. So there’s some interesting research studies that have gotten funded. There’s a lot related to children’s health, pediatric health. So again, it just kind of shows you that women’s health in terms of maternal health is really not prioritized here.

Rebecca Dekker:

You can also look at sorting by organization. And let’s see, you can sort by a couple of different ways. I’m trying to remember the way I found it yesterday. It was interesting to see many of you may live near a university that has a lot of funding. But there is a way if you play around with this enough, you can see how a lot of the funding goes to specific universities that are kind of rich in research funding. Whereas other universities don’t get as much funding. So I just wanted to kind of show you where you could find that.

Rebecca Dekker:

One more thing I wanted to show you. I was going to do a query. So for example, what about research on doulas? Are they funding any research on doulas? So I’ll put the word doulas in here. I’ll leave everything else open. We’ll just look at active programs. We’ll even go all institutes. We’ll just say everybody, the entire NIH $42 billion budget, what research is happening about doulas? Zero. There’s zero projects.

Rebecca Dekker:

Now we can search all fiscal years and go back in time, and we’ll find a few studies here. These are expired. Some of these are from the ’90s and early 2000s. You can sort by fiscal year. The most recent study on doulas was done in 2019 by somebody from the University of Minnesota, Efficacy and Cost-effectiveness of Doula Care for Incarcerated Pregnant Women. Looks like she had two years of funding, about $77,000 a year. And it looks like in 2003, there was somebody who looked at postpartum doula care. And then many of you know John Kennell, one of the researchers who kind of first started writing about doula support. Looks like he had an R01 for years at Case Western Reserve University and was studying the effects of support.

Rebecca Dekker:

So the NIH did support a lot of that initial research on doula care. And then we have a big gap where we just have a couple of small studies happening. So I find that interesting. Same thing if you go back to the query form. I mean, let’s say we’re looking for midwife. We’re looking at something related to midwives. And see if we get anything. Looks like we’re getting a few things. This is all fiscal years though. So if we only look at more recent, there’s something about changing the culture of disrespect and abuse in maternity care in Ghana. Some of these may not actually use midwives. Enhancing Male Participation Interventions to Prevent Unintended Pregnancy, group antenatal care. So there’s a few things going on, Interventions to Reduce Infant Mortality in low-resource settings, that may involve midwives.

Rebecca Dekker:

Here’s one. Says Home Birth in the US: data-driven safety improvements. But there’s not a lot actually being done on midwifery care in the United States. So again, I think it’s really important for you to have a big picture perspective of what’s going on. Amber says, “Wow, I do NIH grant program management. I’m ashamed to admit, I never realized they don’t have a women’s health Institute. No wonder we don’t have current research on the updated topics that impact women’s health.” A lot of people are like, “Do you have research on this? Do you have research on that?” And a lot of times the answer is no, because of what we just talked about. It’s a racist, patriarchal system, the way it’s been set up.

Rebecca Dekker:

Now, you may notice that a lot of times, the research that I do talk about may come from Iran, or Australia, or Norway, or Sweden, or the United Kingdom. And that’s because many of those places prioritize the type of research that we all are interested in. So very often, we won’t have research from the U.S. unless it’s specifically focused on what obstetricians want to do and gynecologists.

Rebecca Dekker:

All right. So now I want to talk about clinical research and the timeline. Keep in mind that this is a multi-year timeline. The first thing that you may do is identify a problem and do a literature review. That might be the easiest and shortest part of the timeline. Next as a researcher would be to collect pilot data if they don’t already have it. But in general, in order to get any kind of funding, you’re going to need some pilot data.

Rebecca Dekker:

Often, you may use a smaller funding source to get money to get the pilot data. So that’s another process where you’re applying for funding for pilot work. Then after you get your pilot study, sorry your pilot data, you can design your study, and write and submit an application for funding. That can take anywhere from three to 12 months, depending on how experienced you are at writing grants, how many people need to approve it, and review it, and give feedback. So it can take up to a year to do the grant application writing process. Again, we’ve already probably spent a year getting pilot data. So now we’re two years into the timeline.

Rebecca Dekker:

After you submit it, you have to wait anywhere from six to 12 months to get feedback. If your grant had a competitive score, you may be able to make revisions and then resubmit it for funding, and then wait another six months or so to find out if it got funded. So now we’re about three or four years down the timeline.

Rebecca Dekker:

As soon as you find out that you got funded, if not before, you’re going to be submitting an application to the institutional review board at your institution for ethical approval for the study. An institutional review board has to sign off on any study. You also have to hire and train your research staff and purchase supplies once you get the money.

Rebecca Dekker:

If you made it through all of that, you successfully have money in the bank. You’ve successfully started your study. That part of the timeline may have taken three or four years. Now it’s time to begin recruiting human subjects. So you are going to have to talk to potential subjects, get informed. First you’ll screen them to see if they’re eligible. And then you’ll talk with them, get their informed consent, which is a very lengthy document typically, to be in a human subject study. Then you’ll be enrolled, and you’ll have to go through the whole baseline data collection with that human subject.

Rebecca Dekker:

If it’s an intervention study, you’ll deliver the intervention or control. You’ll collect follow-up data. You may be following up that person for just a few days, or maybe perhaps six to 12 months, depending on the goals of your study and how long your follow-up period is.

Rebecca Dekker:

So you need to meet your recruitment goal for the study as well as then follow those people for a certain length of time, whether it’s six or 12 months. So you would officially finish the study 12 months after the last date of the last person being enrolled.

Rebecca Dekker:

Then once you have all your data, you would need to organize it, clean it, and analyze it. That doesn’t take too long usually, maybe a month or so. And then once you’ve analyzed your data, most researchers then immediately submit an abstract to a conference so that they can start disseminating the results. And then fewer researchers will actually finally prepare the manuscript for publication.

Rebecca Dekker:

I personally know many researchers who have gotten grant funding. They’ve analyzed the data. They met their recruitment goals. They’ve even gone to a conference and presented. But then they get stalled at the manuscript process, because that process of publishing the data is in itself a multi-year timeline. Once you write your manuscript, which may take three to 12 months depending on how much time you have to write in your schedule, you’ll submit it. And then you got to wait, and then you get feedback. And if they’re willing to let you resubmit, you’ll resubmit it. Getting grant funding or getting your paper published on the first try is extremely rare. You’re more likely going to either get rejected or get feedback, and then resubmit.

Rebecca Dekker:

Finally, your manuscript is published. In the meantime, you should have been constantly submitting multiple applications for new grant funding in the hopes that you will be one of the lucky ones to get funding for your study. Your manuscript may begin to be read and cited, but most manuscripts have very limited reach unless it happens to be picked up by a news outlet. But most of the time, a lot of research only reaches a limited number of people, which one of the things that frustrated me and one of the reasons I started Evidence Based Birth® is because I realized there was this gap where the research was being published, but nobody knew it was out there or had access to it.

Rebecca Dekker:

So, any questions about what I’ve covered so far? Amber mentions, “There’s an Institute on Minority Health and Health Disparities. So that may be worth some of the disparities research.” Okay. Everyone’s saying they’re learning a lot. It’s informative. All right. Good. Okay.

Rebecca Dekker:

So I kind of wanted to give you an overall picture of how research is funded and how it works, the timeline, what a researcher’s role is, all the things that they’re managing. The length of time it takes to get a study done, which makes you realize how fast the turnaround is with COVID-19 and how fast research is being done and published. I mean, that’s like lightning speed. Usually it takes three to five years from start to finish. Maybe longer if you have trouble getting pilot data, or if you have trouble getting funding. For COVID-19, there were a lot of emergency funding calls for proposals where not only National Institutes of Health, but other organizations were all of a sudden putting out a lot of money in emergency purposes for researchers to apply to. And they had rapid funding opportunities. So that’s how that COVID-19 research is being done so quickly.

Rebecca Dekker:

All right, everyone, I’m going to stop there. That was the first 40 minutes of about an hour-long session where we’re talking all about evaluating clinical research. After the section that I just shared with you, we then go on to talk about research methods and understanding the process of how research is actually carried out, as well as the different types of research out there and some recommended books that I own in my library and I recommend that our members get, if they are interested in learning more about evaluating research.

Rebecca Dekker:

I would love for you to take a moment and just think about what’s one thing that you learned today that was new for you, or surprising, or that will strike you and go with you in the future? For many of our professional members, they talked about learning that research can be biased. They talked about they didn’t know how research was funded or that research could be racist and patriarchal.

Rebecca Dekker:

Again, if you’re interested in trying out the professional membership, we have extended the opportunity to have a free trial of our professional membership at Evidence Based Birth®. Through next week, July 20th will be the last day that you can sign up and get a free trial for one month. In your free trial, you’ll have access to all of our courses with continuing education certificates, including this four-hour-long course all about how to evaluate clinical research studies. This one that I shared a sample of today was a live training that we did over the course of four weeks. And all of the recordings are archived for our members in the live training section where there’s recordings of each live training we’ve done.

Rebecca Dekker:

We also have courses all about how to help families get evidence-based care. We have courses about big babies. Gestational diabetes, advanced maternal age, group B strep, newborn procedures, failure to progress, and more. We have an extensive archive library of our past live trainings in addition to the ones I just mentioned. And we have a library full of PDFs that you can use with clients or colleagues.

Rebecca Dekker:

We’re excited to have as many people as possible try out the membership over the next week to get your free trial. Just make sure you go to evidencebasedbirth.com/membership before July 20. Thanks, everyone. And I’ll see you next week. Bye.

Rebecca Dekker:

Today’s podcast was brought to you by the Evidence Based Birth® Professional Membership. The free articles and podcasts we provide to the public are supported by our professional membership program at Evidence Based Birth®. Our members are professionals in the childbirth field who are committed to being change agents in their community. Professional members at EBB get access to continuing education courses with up to 23 contact hours, live monthly training sessions, an exclusive library of printer-friendly PDFs to share with your clients, and a supportive community for asking questions and sharing challenges, struggles, and success stories. We offer monthly and annual plans as well as scholarships for students and for people of color. To learn more, visit ebbirth.com/membership.

 

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