In this episode, we discuss screening for BV to prevent preterm birth. Then new data about the safety of obstetric care in rural vs urban hospitals of different sizes. Plus, new evidence that prophylactic salpingectomy is working and new data about vaginal cuff dehiscence and the analogy between clinical studies and lab tests.
0:02
Treating Bacterial Vaginosis in Pregnancy
Morbidity Rates in Rural and Urban Hospitals
Hospital Size and Patient Care Impact
Maternity Deserts
Salpingectomy for Ovarian Cancer Prevention
Analogy of Clinical Trials
Vaginal Cuff Dehiscence
Follow us on Instagram @thinkingaboutobgyn.
In this episode, we discuss screening for BV to prevent preterm birth. Then new data about the safety of obstetric care in rural vs urban hospitals of different sizes. Plus, new evidence that prophylactic salpingectomy is working and new data about vaginal cuff dehiscence and the analogy between clinical studies and lab tests.
0:02
Treating Bacterial Vaginosis in Pregnancy
Morbidity Rates in Rural and Urban Hospitals
Hospital Size and Patient Care Impact
Maternity Deserts
Salpingectomy for Ovarian Cancer Prevention
Analogy of Clinical Trials
Vaginal Cuff Dehiscence
Follow us on Instagram @thinkingaboutobgyn.
This is Thinking About OPGYN, with your hosts Antonia Roberts and Howard Harrell.
Howard:Antonia.
Antonia:Howard.
Howard:What are we thinking about o today's episode?
Antonia:Well, we're going to talk about the safety of rural versus urban hospitals and then the rates of vaginal cuff dehiscence with different routes of hysterectomy. And then we're ambitious. We've got a lot of different things to talk about. Then we're also going to talk about new evidence about salpingectomy to prevent ovarian cancer. And then there was also a nice analogy between lab tests and research studies in a journal, so we'll try to talk about that too.
Howard:Ambition.
Antonia:Yes, but first what's the thing we do for no reason, Howard.
Howard:Okay. Well, how about screening asymptomatic women for bacterial vaginosis in an effort to prevent preterm labor? Or, for that matter, even screening women who come to triage We've had some contractions perhaps with a vaginitis probe or a wet mount to look for bacterial vaginosis as a routine workup for their preterm contractions.
Antonia:Antonia, okay, sure, I have certainly seen that latter scenario much more often and I'm guessing it might be more a common place than just screening every pregnant woman without symptoms. But I could be wrong. But we do know that bacterial vaginosis is a risk factor for preterm birth. It increases that risk anywhere from two-fold up to seven-fold depending on the gestational age at diagnosis. Essentially, the earlier you diagnose it, the higher risk for preterm birth, and we've known this for a long time. But the question all along has been whether or not screening for it and treating for it does anything to reduce that risk. So, in other words, is this like a modifiable risk factor or is it more like a sign of some common, underlying common denominator, like a predisposition towards both preterm labor and towards BV, maybe like an inflammatory state or immune dysfunction kind of thing where you could treat the BV but it wouldn't affect that underlying common denominator?
Howard:Yeah, another example might be pre-dentition. We also know that that's a significant risk factor for preterm birth, but it turns out that just treating poor dentition during pregnancy doesn't do anything to change the patient's risk for preterm birth, even though we tried that for a while. And much of the same story seems to be true for bacterial vaginosis. Poor dentition and BV may both be signs, as you said, of some underlying immune issue, some immune deficiency or poor immune response that's also associated with preterm birth, which has an inflammatory or perhaps infectious etiology as well, rather than a direct causation.
Antonia:Yeah, so it's the same old correlation doesn't equal causation debate. This is something that goes back and forth in the OB literature, though there's been at least three meta-analyses looking at whether or not screening and treating for BV in pregnancy has any impact on preterm labor, and depending on which studies you choose to include or not, then you see different results and different conclusions. One review by Lamont looked at five studies and they reported a benefit of screening and treating with clindamycin. But then the Cochran database looked at 21 studies and based on the entirety of those, they did not recommend screening. And this was just in Cochran's most recent review of this topic. And even more recently, the US Preventative Services Task Force looked at 48 studies, and that included a large one that came after those other reviews I just mentioned, and they also concluded, based on all those 48 studies, that there's no benefit for screening or detecting or treating asymptomatic BV in the general pregnant population. And then looking specifically at high risk women, like women who have previously had a preterm delivery, even for them the data was inconclusive.
Howard:Right. So, despite all what you just said, it's still a pretty common practice that folks will screen or screen at least patients who come to triage. I think that OB residents are taught fairly routinely to think of bacterial vaginosis as a cause of preterm contractions or preterm labor, rather than just an associated risk factor. And in the spirit of having a thorough differential diagnosis or maybe just wanting to treat something, to find something wrong with the patient and get the pain out of triage, they're expected to look for it in patient who present to labor and delivery, complaining of some contractions even if they're not found to be in preterm labor. In other words, they just have preterm contractions. And yeah, some might even be taught to screen for BV in a new OB visit since, as you said, the earlier it's detected, the bigger the risk for preterm labor. So find it early and treat it. But the best evidence says that treating it does not help.
Antonia:Yeah, this is an example of something where there's mixed data or maybe contradictory results or guidelines, again, depending on which studies you look at. So some people just decide well, if it's inconclusive, I'll err on the side of doing more because it might help someone, whereas on the flip side, other people will take it as clear evidence of no benefit, like, if it's not conclusive, then it's not beneficial.
Howard:Yeah, there's a bias either to do, I think, too much, which we call the commission bias, or a bias to do too little, which is an emission bias, and people fall out on one side of the other of this. And this is especially true, this presence of a commission bias, I think, with a lot of the things surrounding preterm labor that we've discussed many times before, including things like the tocolytics we talked about, progesterone or bedrest activity restriction, pelvic rest, lots of other things where the data simply says it doesn't work. But if there's ever been a single report or speculation or plausible physiologic mechanism by which it might work, that people keep doing it, thinking well, it's not harming and maybe it'll help someone, even though it doesn't work in large studies.
Antonia:Yeah, lots of examples of this, this same bias tendency. I think progesterone for recurrent miscarriage, like early in the first trimester, is another example.
Howard:Yeah, definitely.
Howard:Well, there's a new trial in July 17, 2023, from a randomized controlled trial in France called the ALTOP trial AUTOP they have French clever titles there.
Howard:I think this ends up being now the largest trial ever to look at this problem. So this was done at 19 French Perinatal Centers over a two and a half year period and low risk women before 20 weeks gestation were enrolled. Low risk means that they essentially didn't have any prior preterm births or late miscarriages something 1918 week miscarriages. They were randomized in a one-to-one manner to either have a BV screen and then treatment based upon the results, or to just usual care. They used a PCR test and overall they found that the screen and treat approach was not effective at reducing the rates of preterm birth in that population. Now, as usual in a breakout group here the small subgroup they suggested there might still be a benefit among nulliparous patients and unfortunately this just kicks the ball down the field a little bit more when we draw again inappropriate conclusions from underpowered subset groups. But they didn't handle this well. They didn't claim to have found something, they just said that might be an area where another study could be done.
Antonia:Yeah, that's fine to pull out tiny subgroups. It's appropriate actually, I think, to look at data if you do a study and then determine just where you think the new research directions might be. But no one should take this negative study about screening and treating BV in pregnancy and decide that they're just going to do it in nulliparous patients rather than low risk multips, especially when we have so many other negative studies already. The assumption should be that this comment they make on the nulliparous patients is perhaps an idea or even an unverified conclusion in an underpowered subgroup, not that it's any kind of hard or even moderately reasonable scientific evidence that would direct treatment.
Howard:I do think we confuse a lot me being the medical community confuse a lot what is preliminary hypothesis generating types of studies or types of analyses and what is tends to be hypothesis confirming types of studies.
Howard:So almost all retrospective or cross-sectional type data, survey data, risk factor association type data. All that is hypothesis generating and almost never should it inform actual clinical practice. And the same thing is true for the subsets and different kind of analysis of stratified data in studies like this. It is hypothesis generating. It's not conclusion forming, if you will. But yeah, we see this mistake all the time when people take an underpowered subgroup or data from a subgroup that wasn't intended to find some result and run with it and act like it is the truth all of a sudden.
Howard:But the conclusion here is that we should not be routinely screening and treating asymptomatic women in an effort to reduce bacterial vaginosis. The data just doesn't support it in either group and until new studies do that's what it says it's most likely that, as we said before, the bacterial vaginosis is not the direct cause of preterm labor, but that it represents something different about that particular woman's again I don't know immune system or susceptibility to inflammatory processes, something like that. So that bacterial vaginosis and poor dentition for that matter, and probably other similar things and preterm labor are both symptoms of an underlying common pathology.
Antonia:All right then, but what about the women who present with symptoms of preterm labor? If they come into the hospital contracting, does that mean that they could be symptomatic of possibly having BV? Because we just mentioned the residents doing this test a lot on these women.
Howard:I think that's the argument sometimes, but no, I would say that those women who have preterm contractions that that is not a symptom of bacterial vaginosis, the symptoms of bacterial vaginosis. When we say symptomatic, we don't mean uterine contractions. Symptoms are a foul-smelling vaginal discharge. So no, there's no evidence that we should be routinely screening women for BV when they present with preterm contractions, unless they also, by the way, complain of foul-smelling or irritating discharge.
Antonia:All right, then let's move on. I know you've been doing some work in Tennessee trying to advocate for shoring up resources and access to rural hospitals that do obstetrics and also trying to help reverse the trend of the number of maternity deserts that exist. We've talked about maternity deserts before. Well, you probably saw there's a new article in the JAMA Health Forum that looks at the risk of severe maternal morbidity in patients who gave birth at rural versus urban US hospitals.
Howard:Yeah, this is another study derived from a database we've talked about before involving about 11 million births, and they found that the risk of severe maternal morbidity was elevated for women who gave birth at rural hospitals that had fewer than 460 births per year. Now, of course there's a range it's not a black and white cut off at exactly 460, but the highest risk was at hospitals with fewer than 110 births per year, and the maternal risks incrementally decreased as the hospital had increasing volume. Up to 240 births was a bit safer than less than 110, and up to 460 births was still safer yet, but the safest was a hospital with more than 460 births a year, at least the way they stratified the data in a rural setting. There was a pretty wide range of outcomes, though Some small hospitals provided a high standard of excellent outcomes, while some large hospitals appeared to have more poor outcomes. So there are obviously a lot of variables, but on the whole, on average, the lower the volume at rural hospitals, the higher the significant morbidity and mortality rates.
Antonia:The fascinating thing about what they found was that this was not the trend in urban hospitals, and they had to compare this in several ways.
Antonia:So in one of their charts they included all urban hospitals within this data set of 11 million births, and for that they had to use different definitions for low, medium, high volume deliveries than what we just listed for rural, because urban hospitals they range on a much larger scale.
Antonia:You won't find a rural hospital that delivers like 10,000 babies per year, but there are urban hospitals that do so. For urban they considered high volume to be more than 2,000 births a year, and remember rural was 460. For urban, low volume was anything up to 500 deliveries, and then they had medium category 500 to 1,000, and then a medium high category 1,000 to 2,000. So in this comparison the very highest volume for a rural hospital would have been equivalent to the very lowest volume urban hospital category. So in a way that's useful because it captures all the urban hospitals, but in another way it makes it harder to draw conclusions. So they did also find some urban hospitals that had very few deliveries, including some that had less than 110 per year, and so then they made a separate comparison all the rural hospitals compared to just those urban ones that had very relatively low volume, so that they actually matched up the same delivery numbers per category. So there was a less than 110 category, up to 240, up to 460, and so on.
Howard:Well, that probably represents a very small minority of urban hospitals, of course. So again, maybe difficult to draw firm conclusions from the smaller comparison. Generally, there's fundamental differences in how hospitals are resourced and how they operate, based upon their location. Rural and urban hospitals have different resources, different staffs, different things. So even if the number categories were the same, we might still be comparing apples to oranges.
Antonia:Yeah, that's true and I think they do discuss that.
Antonia:But I think it's nice that they compared it in both ways so you can at least get a glimpse of what the differences are when we actually arc matching up the delivery volumes.
Antonia:Maybe it was an attempt to head off those criticisms about how you wouldn't be able to compare them to rural hospital 460 deliveries to an urban hospital that has 10,000 deliveries. But you are right, the total number of patients in that smaller urban comparison was less than the patients at the rural hospitals by at least 100,000 women. So maybe not enough patients to even draw proper conclusion, like you said. But taking all those caveats into consideration, this smaller comparison with the smaller urban hospitals found that only that lowest volume category of less than 110 deliveries per year, only that category had more severe maternal morbidity than those other groups. And even then it wasn't as big of a difference as that linear trend that you described with the rural ones, where it was the worst with the least volume and linearly decreased with increasing volume. So I think they're at least trying to suggest here that rural hospitals are specifically the ones that suffer from having a low delivery volume, not just any hospital anywhere that happens to have a low volume. They're trying to show that it's just the rural ones.
Howard:Yeah, if anything we learned from that, it's maybe that once your hospital's doing less than 10 deliveries a month, that may be a critical place where it's hard to maintain a quality program, whether it's in a rural setting or an urban setting. And it might be tempting from all that to conclude that urban hospitals must be safer than rural hospitals, but the overall rate of severe maternal morbidities they're still very comparable between the two. In fact, for the worst groups so in other words the very lowest volume hospitals, the rate of severe maternal morbidity was the same at about 0.7%, whether they were urban or rural. It's just that further increase of delivery volumes were associated with different trends in maternal outcomes depending on rural or urban settings. So while more than 460 deliveries was the safest in the rural setting, with a severe maternal morbidity rate of 0.47%, the mid-lower volume centers were actually even safer in the urban centers at a rate of 0.4%, which is about the same.
Howard:That actually represents a more drastic difference than with the rural hospitals and in their discussion the authors attribute this to a better ability for those mid to low volume small urban hospitals to refer patients out as needed, and in this small comparison they didn't separate out high versus low risk patients, like they did in the main comparison. So it's very likely that improved rates at the mid to low urban hospitals represents having less high risk patients. It may be that the larger hospital all the high risk patients go there, and the smaller mid to low volume hospital is where low risk patients aggregate. And the authors didn't actually discuss at all how to make specifically the ultra low volume urban hospitals any safer, even though they had the same severe maternal morbidity rates as the smallest rural hospitals. Again, it just may be that under 110, it's hard to do anything in either setting.
Antonia:Yeah, and it is good that at least with the comparison where they had all of the urban hospitals, even the 10,000 plus ones, that they separated out high versus low risk patients, because the high risk patients will tend to get sent out to those higher volume facilities and that would definitely skew the morbidity rates if we weren't paying attention to it. So when we look at those patient risk comparisons we find in this study that specifically the low risk rural patients had the biggest disparities in maternal morbidity outcomes based on the delivery volume of where they had their babies. So again, regardless of the maternal risk status at urban hospitals, there really were no differences in those maternal morbidity rates in that main comparison where it was like 500 deliveries, 1000, 2000 plus. So again we have to take into account the caveats of having the different delivery numbers being different categories.
Howard:They discussed some of the possible reasons and solutions for this disparity in maternal outcomes, and obviously shutting down those rural hospitals or taking resources away from them would be even worse. So many women would go from a suboptimally resourced rural hospital to a maternity desert with no hospital or no medical care at all, at least within a safe and reasonable distance from home. So the authors call for more resources for rural hospitals and mention a couple of programs like the CMS, birthing friendly hospital and the rural emergency hospital designations that are meant to help improve those specific services in rural hospitals, and there's a few other suggestions I could easily spend at least the next hour or more talking about.
Antonia:We should get into some of that of what you've been working on maybe not for a whole hour right now, but I don't know maybe 30 minutes to talk about that. But this finding of the low-risk patients having worse outcomes does raise questions about what's going on with them in the rural settings. Maybe the most attention and resources in those remote hospitals get pulled away to the high-risk patients because they didn't have that much of a disparity in outcomes. And then in those small hospitals with limited staffing, maybe that detracts from routine care, detracts from properly identifying when does a low-risk patient actually become high-risk and then she just goes on to be mislabeled as low-risk. Or maybe they're just not that well prepared for emergencies like hemorrhage or sepsis or the things that would lead to severe maternal morbidity.
Antonia:And then, regardless of what the process is for this disparity, you have to also wonder is it purely from a lack of resources? Or is it also from a lack of volume that leads to a lack of clinical experience and judgment? Because those very lowest volume hospitals are also the least likely to have any kind of training program, especially residency training program. And if it's not enough volume for a resident to achieve competence over four years, then how do you ensure that it's enough volume for an attending physician to maintain competence year in and year out?
Howard:Well, of course those aren't one-to-one associations, but I mean a residency program with 24 residents a year might have 80 faculty and a small hospital might have four or five folks. So I don't know that correlates to folks in rural areas having less care or less care, but it does probably get into if you're a hospitalist or something and you're doing hundreds of deliveries a year, versus 90 deliveries a year for the average of a GYN. Maybe that makes a difference.
Antonia:Yeah. Or if someone is doing like less than one delivery a week, for example, that's yeah, right, yeah.
Howard:Which easily might be the case in these very low hospitals. But I think for the most part stuff scales. It's just that at a certain point it doesn't scale Like. You need a certain number of nurses per delivering patients per year and you might work at a busier hospital, but instead of being one of four or five doctors you're one of 50 doctors and instead of being one of 20 nurses you're one of 120 nurses. So at a certain point there is a correct amount, a right amount, and it's hard to meet that at the fringes. I think the two busy hospitals may overwork folks and their shortcuts taken and the two small hospitals may not provide enough experience. There is a hospital this week that was cited by the state of California in Los Angeles. It's one of the busiest hospitals in Los Angeles.
Howard:They were cited for a patient who died after a C-section and they specifically talked about basically being busy and taking shortcuts. So they weren't doing quality improvement projects, they didn't have a hemorrhage protocol, they weren't staffed sufficiently to look for signs of hemorrhage in the postoperative patient. So you can be too busy and not have that right fit number, and you can be just too slow and not have the right fit number too or not have the right clinical experience. But I do think residency programs and educational programs add a layer of protection, if you will, in the sense of there's more eyes on the problem, more discussion, et cetera.
Antonia:Yeah, definitely there's several additional layers of attention to patients when you have residents and four different year levels of residents on your team and all of them are learning and questioning things and watching you closely and asking what guideline was that from again.
Antonia:So that's a little bit of built in, I think, accountability. Now, obviously the majority of hospitals are not academic, so that's a rare luxury, if you will. But certainly outside of the academic setting, the physicians have to put all of that rigor on themselves voluntarily, because it's not built in for them. There's no one that's following them around and asking questions and mimicking them and writing things up for a weekly M&M conference or a weekly quiz or anything like that. So I imagine, even especially at a small, maybe poorly resourced community hospital, even the most conscientious doctor that's every day thinking about am I doing things right? What are the newest guidelines? That doctor may still have difficulties getting the time or the support to go to conference and do their maintenance training for whatever they're getting rusty on, because their hospital is just so short staffed and they can't go.
Howard:Yeah, I think it cuts both ways. I definitely think all that's true, and physicians in general are resistant to new programs like the hemorrhage or other hypertension bundles and things like that that we're trying to put into hospitals.
Howard:Recently in Tennessee, we worked on optimal cord clamping in the birthing hospitals in Tennessee and yeah there was a lot of resistance in small centers, in some places in different sizes, but in general, at the larger facilities there was more acceptance and uptake, probably just from peer pressure. If you're one person in four who doesn't want to do optimal cord clamping and you're a big personality, then you probably get away with it, but if you're the one outlier in 30, there's more peer pressure. So, and again, when you add in trainees, whether it's medical students or residents or whatever, those doctors or students, student doctors make a difference, those doctors in those settings that don't have any academic program at all, or students or whatever, then they, as you said, they don't have folks watching them, they don't have folks asking questions. There's less scrutiny, there's less layers of accountability. There are no perhaps set down rounds and checkout rounds or M&M conferences, things like that. So the burden is entirely on you to keep up to practice and up to date with evidence-based care and stay current and change without peer support.
Howard:To change I mean also changing in an isolated situation without a lot of peers around you. Changing at the same time or indicating this is the right thing to do can be scary for people, so they stick with what they know. And if you do have something go wrong and a case is reviewed by someone internally, well, it may be reviewed by a friend of theirs it's a very small department or somebody who just doesn't have any more expertise than they do. So there's all kinds of variation in how hospitals and departments handle continuing education and clinical quality, and those things tend to be more formalized at larger centers. On the flip side, as I said, if hospitals get too big, like this LA hospital, there's probably a loss of individualized care and certainly continuity of care, and, yes, more learners are involved in the mix, and things, though, because of that, tend to become more like a depersonalized assembly line and they can get understaffed, which is probably the case with this LA hospital.
Howard:That's not just a rule problem, especially when they have volume surges. So there may be a sweet spot beyond which more deliveries at least per physician, per nurse, per staffing unit or bed size or whatever is no longer make, no longer makes things better. But in this data, only when they did not adjust for patient clinical characteristics severe maternal morbidity was consistently lower in the medium delivery groups, 500 to 1000. In other groups it was maybe lower for low risk patients in one category, then only lower for high risk patients. In another, but again only in unadjusted data, and these patient characteristics, adjusted for, included maternal age, race, education status, insurance status and a co-morbidity score. They didn't include a breakdown of how these characteristics related, though, to severe maternal morbidity outcomes.
Antonia:Yeah, but they did show separate breakdowns of these patient characteristics that they made their adjustments with in each of the urban versus rural states that they looked at and in each separate hospital volume category within each of those states. But it sounds like those characteristics at any given hospital are something that can be tracked but they can't control.
Howard:Yeah, they did point out that the Medicaid mix, of course, is much greater in the rule access areas, along with your inheriting in that environment patients with poor social determinants, and of course the implication of that is that payment enhancements for lower volume hospitals that primarily treat Medicaid patients could help address some of these resource constraints and the availability of clinicians and just the financial viability that small hospitals face and staffing and things like that.
Antonia:And are those the sort of recommendations you've been promoting for Tennessee?
Howard:Yeah, I mean, I think the lesson here is that there is a right size and that patients need to be in the right center. So there are many patients who the rural hospital just serves as a transfer point to get them, or their unborn fetus that's at high risk for needing a NICU or something, to the right place where the right care can be delivered. But even for low risk patients there's a right size, there's a right number of deliveries per clinician, per nurse, per whatever, and you know that. I think that's what this gets at. And on the edges of not being right sized you start to see things missed. So we need to find something workable and that isn't just pushing rural patients into larger urban hospitals that probably aren't suited to handle that extra volume anyway. You might just end up increasing the maternal morbidity and depersonalized care and things like that in those urban hospitals, in addition to significantly disrupting the lives and communities of those rural patients who are getting transferred to that urban setting. So that just is a lose lose situation.
Howard:This data definitely supports that. Even now, a rural hospital that can deliver, say, between 460,000 babies a year can deliver world class care that's comparable to that of any urban hospital, if it's appropriately resourced and, of course, if it appropriately transfers patients that need other resources out of that hospital to a tertiary center, and that's true for both low risk and high risk patient populations. The challenge, though, is to improve outcomes for patients who currently end up in the very lowest volume hospitals, and if those are still the closest facilities, within an hour or two of where a patient might live, then the answer still may not be to shut that hospital down or make all the pregnant women in that area travel to the city for their care or their antenatal, probably and delivery care. The answer is to help that hospital get up to the level of a higher volume that's needed to maintain basic quality care for basic obstetric safety.
Antonia:So what are some specific things that you're advocating for to make this problem better?
Howard:Well. As the article points out, medicaid needs essentially to pay a premium for women who deliver in a rural access hospital. States could also step in with dollars or tort reform measures that help with liability concerns. These small hospitals have to carry liability insurance like everybody else does, and the financial aspects surrounding that insurance can just be devastating to the budgets. A reason to close the unit eventually, and things like loan repayment that favors physicians. Moving to more rural areas after training rather than an urban area, could help attract physicians and retain physicians into areas that need them where there are maternity deserts, and the same thing could be done for nursing staff as well.
Howard:Nurses in many rural areas travel to the nearest big city to work because of slightly better payment or whatever. Unfortunately, all of the payment structures incentivize people to live in urban areas. But state legislators do have some control over these issues, and the federal government does through the CMS program, which right now unfortunately favors higher reimbursement to urban areas and lower reimbursement to rural areas. And there's some sense of that, because it costs more to run a hospital or have a healthcare resource in an urban area due to cost of living. But it's so skewed that right now, for the most part, hospitals are giving up on rural areas because the payment is so much better. If you're going to build a new service or maintain a service, the zip code it's in determines how much money you make, and that shouldn't be.
Antonia:Yeah, I can see how that would be a big challenge. I just went through the process myself of looking for where to settle down after completing the military service and being able to pick for myself where I want to live, and I saw lots of jawbats for some pretty rural locations that were advertising massive salaries. It's not just about the money, though, so they have to offer enough money to overcome all these other things that it's hard to compete against a city for, like well, being close to family and friends and good schools and things you can do in a city, like nice parks, gyms, whatever, shopping kind of stuff that you might not find all of those things in a rural area. So, yeah, I could they get less money, but then they have to offer more money just to get someone to work there. Yeah, I can see how that would be tricky, and obviously all of that is probably outside the scope of the city. It isn't.
Howard:It isn't. It isn't when you realize that in rural Tennessee, for example, in most of the counties that have hospitals in Tennessee, the healthcare system and hospital system is the largest employer. So keeping folks there who are in the healthcare services nurses, et cetera, pharmacists, physicians, whoever that have these good, high paying jobs associated with it, or is what builds a strong community and the good schools and the tax spaces that you're talking about. So we're, unfortunately, we're on the other end of a decades long redistribution of money in the healthcare dollars at least, from urban to rural areas, and so when a rural hospital closes, it devastates the local industries. Major manufacturing plants and industries don't want to look for communities to settle in that don't have hospitals. So it's a vicious cycle. You've got to have high quality healthcare and a hospital in the community to attract the jobs that increase the tax basis, that build the parks and build the schools et cetera.
Howard:So CMS does have control over this and they've contributed this problem over the last 30 years.
Antonia:Yeah, so they need to take notice and start turning the tides. I know one of the other short term fixes that happens right now is where doctors will take a locum's period, maybe even just a weekend at a time or a couple of weeks at a time, to fly out to somewhere and maybe live in a rental or hotel and just take call and then fly back to wherever they're from. And obviously that has downsides to it, but right, now?
Howard:well, it's financially unsustainable, though. I mean, there's so much more expensive to hire that sort of physician and they're also not gonna come in and be dedicated to types of quality improvement projects and things that stabilize the hospital. They're just in and out and they charge a lot for that service.
Antonia:Yeah, it's like a bandaid, so yeah, so that's not what we should be trying to push for more of. But anyway, if anyone, especially in Tennessee, is looking to get involved with that sort of advocacy, certainly they can email us and we could help point them in the right direction. But I'm sure many other states in the US are working on similar projects and I think if anyone even outside of the US wants to tell us how they've seen the rural obstetric care being handled, that would be really interesting to hear about. So let us know.
Howard:There are maternity deserts in urban areas as well. This problem isn't just actually with rural areas, and the same sorts of problems is creating some of those urban air maternity deserts. So as rural volumes increasingly shift into the city and the city, hospitals become overwhelmed with new patients and then city hospitals can also are just financially they're consolidating. The effect has been to create some very, very high volume hospitals in a city that are very, very, very busy. In this paper, the highest volume hospitals had more than 10,000 deliveries a year and none of them had severe maternal morbidity rates as low as some of the hospitals in that 500,000 per year range.
Howard:In a larger city, with traffic and hospital consolidation forcing everybody to one or two places and then poor transportation issues, a woman who lives in the city or on the perimeter of the city might still find herself an hour away from a hospital where she can get obstetric care in the event of an obstetric emergency. And there are hospitals within the big city that don't have OBGYNs on staff because they've shifted it all to one place. So she may go to the emergency department with postpartum cardiomyopathy and not have the ability to get a consultation from an OBGYN because there are no OBGYNs there anymore, and then, when she gets to that big hospital that does 10,000 deliveries, she may find inattentive care due to a lack of space and just getting out fires and getting to the next emergency, because those hospitals have limited resources too. So that could create a situation just as bad, if not worse, than what many women in rural areas face with downsizing, enclosures and a lack of access. We should be promoting access everywhere.
Antonia:Yeah, that example you just brought up with postpartum cardiomyopathy harkens back to what we talked about a little while ago with racial disparities, with out-of-hospital maternal mortality rates and also with severe morbidities. And for that condition, especially the cardiomyopathy, delayed diagnosis worsens the outcome significantly and it's going to be delayed. If it's being assessed by someone who's not an obstetrician, it's not on their mind to look for that, and many of the women in the inner city probably are African American women who are basically living in these urban obstetric deserts, as you mentioned. So that might also be a big reason for their disparities in mortality and morbidity.
Howard:Yeah, one of the areas we've identified to help with that postpartum cardiomyopathy problem in particular to address is not training OBGYNs, is training non-OBGYNs who see these patients to recognize that that woman needs care. And so we know, that's true that these women are going into urban maternity deserts and not getting diagnosed.
Antonia:Agreed, let's move on to a different one.
Howard:All right. Well, in the June 20th edition of the Journal of the American Medical Association, there was a couple of interesting editorials. One is about opportunistic salpingectomy for ovarian cancer prevention by Rebecca Stone and her colleagues at Hopkins. The practice of opportunistic salpingectomy to prevent ovarian cancer really started, originally based upon some observational data and theory, but last year, in 2022, there was a trial published by Canadian researchers. That was really the first piece of prospective evidence that we've had that shows that this is a successful strategy.
Howard:So they followed 25,889 women who underwent opportunistic salp injectomy and compared them to over 32,000 women who had either had a hysterectomy alone or a tubal ligation alone so a partial salp injectomy between 2008 and 2017. And at the time of follow-up they reported no high-grade serous cancers and five or fewer epithelial cancers in the women who had undergone salp injectomy. So a quick refresher serous is the most common subset of epithelial, which is the most common type overall among ovarian cancers. Now, based on the rates of cancers in the control group and what's already previously been known about the incidence of ovarian cancer, they would have expected to see 5.2 compared to zero and 8.6 compared to under five cancers in those two groups. So this is the first real-world evidence that this approach is working.
Antonia:Yeah, I think we've been waiting for some hard evidence on this and I think it's invigorated the idea that salp injectomy complete removal of the fallopian tube should be done whenever possible when a woman desires sterilization and she's already getting a surgery where that can be easily done. So if just a hysterectomy, for example leaving the fallopian tubes already, is going to reduce the ovarian cancer risk by about 30%, that would translate to the average woman going from like a 1.4% lifetime risk to slightly less than 1% risk after getting that procedure. The suspected explanation is there's less blood flow to the ovaries in fallopian tubes or something. But that's how that's. What's been observed is about 30% risk reduction. But this study now is the first to really clearly show that, yes, complete fallopian tube removal is even better than just removing the uterus or just removing part of the tubes. But the reductions, the fact that they still saw from eight expected cancers down to five or less of the epithelial ovarian, might seem like a fractional or even maybe even a disappointing improvement.
Antonia:But we have to remember that even if you did a complete oophorectomy, you wouldn't fully eliminate the risk of ovarian cancer. In that case someone still gets it. You might call it primary peritoneal cancer instead, but it's essentially the same entity. So either way, we're always going to have to accept some residual cancer risk of ovarian cancer, and we already know that doing an opportunistic oophorectomy is net harmful in an average risk asymptomatic younger woman. So we're not talking about that at all. That's not for debate. We're talking about the more benign practice of removing the entire fallopian tube in someone who is otherwise going to get them tied off or have a hysterectomy. She was already not going to use them anymore to get pregnant. So in real numbers, what this found was that out of the 25,000-ish women who got complete self-injectomy in this study, maybe about nine or 10 of them were spared from developing ovarian cancer because of that complete self-injectomy over just a few years. Probably over time more and more of them would have been spared.
Howard:Yeah, that was just over. I think the average follow-up was just a smidge under five years. So obviously those numbers will scale as time goes on. But the editorial, though, raises an interesting idea.
Howard:So while OBGYNs have been looking to do opportunistic salpingectomies at the time of hysterectomy or for sterilization for some time, women undergo lots of other surgeries in the course of a year for lots of other reasons, and opportunities are being missed. So, for example, hundreds of thousands of women in the US each year undergo surgeries like cholecystectomies or appendectomies or hernia repairs or other intra-abdominal surgeries where fallopian tubes could be removed if the patient didn't desire future fertility. And this broader reach, this idea of a more expansive program of prophylactic self-injectomy, could save over time a couple of thousand lives a year and significant money, since more of these surgeries are being done each year than hysterectomies anyway. And the projection is that if we had full uptake of this procedure at the time of hysterectomy, just for that we could save 2,000 deaths a year and half a billion dollars. So we could do better than that if we added in opportunistic self-injectomy at the time of other general surgical procedures.
Antonia:Yeah, especially when recently we've heard about worldwide shortages and common chemotherapy drugs. Saving any ovarian cancer cases, especially with something as easy as just fallopian tube removal, would be great. And it's an interesting idea to put this on a non-gynecologist because and in this study they also pointed it out that there's no surgical cancer prevention program right now that encompasses multiple specialties. So if someone getting an appendectomy was going to also be offered an opportunistic , we would need the general surgeons either to do that themselves, so they would have to learn how to do it, and I'm sure they would learn it very easily.
Howard:Not hard.
Antonia:Or it's not hard, it's very easy, it's like intern level, or we would have to have a system where they call in intraoperatively a gynecologist who would come in and just do that portion of the surgery. But in either case, with the primary procedure being that general surgery case, the patient would need to be appropriately identified and counseled and educated beforehand and offered this procedure and had the risks and benefits explained. And right now, in many cases, especially depending on insurance status, the patient would need to sign these federal sterilization papers that have a 30-day wait time, and so that's not going to be doable for any unscheduled procedures, like many appendectomies or cholecystectomies are, unfortunately.
Howard:Yeah, yeah. And they point out that having opportunistic self-injectomy labeled as a form of sterilization in our CPT codes is a problem due to this legally mandated waiting period for sterilization. If it were coded as something else, like cancer prevention, and it was clear that the surgery was being done for that reason, then that would dramatically improve those circumstances and those opportunities. But I do think it's an interesting idea and an opportunity for multi-specialty collaboration. If the surgeries were done at the time of other general surgeries, the cost for a patient would be very small and likely very cost effective, given the number of lives and dollars saved over time by preventing ovarian cancer.
Antonia:Yeah, they wouldn't have to go through two separate surgeries for two minor or minimally invasive procedures. That could be done just with the single OR day single anesthesia. I'd be curious to hear what general surgeons think about this proposed collaboration from this study because I'm sure if the tables were turned let's say it was shown that some kind of general surgical procedure that was done opportunistically, like an appendectomy for example, let's say it was shown to have a huge net benefit, then I'm sure that many gynecologists would also make a point of becoming proficient at that as an add-on to whatever GYN procedure they're doing, like let's do a hysterectomy and then this opportunistic whatever. And in fact they used to do appendectomies commonly and I still see it show up on different privilege forms as an option for me to tick off. Do I want to which? I don't tick them off, I haven't been trained in it.
Howard:But yeah, obgyns used to do over a million appendectomies a year. We actually used to do more than surgeons, because they would be done at every hysterectomy and every C-section, practically.
Antonia:Yeah, yeah, because from my understanding it was believed before that an opportunistic appendectomy for someone that doesn't have appendicitis or anything would save them from future appendicitis. But we don't do it now, we don't do it anymore because there's extra surgical risk and complications that you're exposing them to and I guess the risk-benefit ratio there is just not worth it. So anyway, you said there was another editorial in that same journal edition that you also liked. Is this the analogy one?
Howard:Yeah, so yeah, there's an editorial that discusses the analogy between clinical trials and diagnostic tests, and this is something I talk a lot about. This was written to stimulate conversations about what a negative controlled trial means, and the editorial finds it useful to liken clinical trials to diagnostic tests. So clinicians use diagnostic tests every day and are, hopefully, intimately familiar with their strengths, limitations, quirks, etc. Whereas they don't usually have the same working knowledge or intimate understanding of clinical trials. Now I love to talk about this. In fact, the math and statistics involved in the interpretation of clinical trials is exactly the same math and statistics needed for the interpretation of clinical laboratory test interpretation. A p-value in a clinical trial represents the tails of the standard distribution of expected results and similarly the high and low ends of normal results of any quantitative clinical test. So not just positive or negative, but you know the range of numbers, the stuff that turns up red. They merely demarcate the median plus or minus two standard deviations in the same way that the p-value does. So the results beyond those parameters have the same statistical meaning as a p-value, and the editorial highlights this point and also notes that it's not a new concept. That was published in the journal over 30 years ago. This is a large emphasis of what I write about in my book Clinical Reasoning, and essentially the editors, without saying it, are encouraging a Bayesian approach to interpreting both clinical trials and lab results.
Howard:A normal lab result or a negative clinical trial don't necessarily mean that a patient doesn't have a disease or that the intervention being studied doesn't have merit.
Howard:But in the same way the opposites are also true An abnormal lab result or a positive clinical trial doesn't necessarily mean that a patient does have a disease or that a clinical hypothesis is true. So in both cases, pretest probability matters. Now they encourage a likelihood or ratio approach to thinking about how the results of a test or the results of a clinical trial alter what a Bayesian would call the prior probability of your hypothesis. But it's all the same stuff. It uses slightly different terms, to put it in the language commonly used by frequentist statisticians, and talks about likelihood ratios rather than Bayes' factors for the Bayesian and other equivalent substitutions. But the spirit of it's excellent and their reason for it is maybe different than my reason for approaching it, but it is high time that folks realize that these trials are not all or nothing, that p-value doesn't demarcate truth from falsity and also clinical lab tests. Normal and abnormal tests aren't the arbiter of whether a patient has a disease or not.
Antonia:Yeah, I think the whole purpose of this article is to translate something about clinical studies into terms that maybe many practicing clinicians are more familiar with, where they order lab tests all day, read lab tests all day, but they're not every day designing trials or reviewing trials or that familiar with the pitfalls of trials, so to speak. So just to translate all of this if you test someone for a disease who probably doesn't have it so like for me, who has zero joint pain if you tested me for arthritis there's some lab tests that could indicate that and the tests came back positive that result would probably mean something different than if you did that same test on someone who very obviously already has it and you're almost just confirming, like someone with severe joint pain, otherwise unexplained, and family history of arthritis. Test them and the test is positive, that confirms it. But again, if you test me, then you would think maybe something else, something got messed up with that test. It's not a perfect test.
Antonia:And then the inverse is true. So if you test someone who almost certainly has the disease and it's negative, then you'd say, well, I still think they have it very likely. So that might be a false negative, because there are false negatives with this test, whereas that same negative result in me, who already had the low chance. That's probably a reliable, true negative, because we know from our everyday practice that clinical tests are not perfect. They have to be used appropriately and interpreted with caution. The exact same things are true for clinical trials, because they also are not perfect and have to be used responsibly, done responsibly and then interpreted again with caution. And you go into great detail of all of that in your book.
Howard:Well, it's good to see more and more articles like this being published. I do think we've moved away. Years ago, when I was a med student carried a Fagan nomogram in my pocket, we talked about likelihood ratios. I don't see that that often anymore. We've moved away in the electronic era from thinking about these tests in a likelihood ratio, pre-test, post-test probability manner, and so this article is a reminder that's how we interpret tests and extending that also to clinical trials.
Howard:If you don't know what a Fagan nomogram is or a likelihood ratio, please read the book. But yeah, we're quietly seeing a revolution, I think, in Bayesian inference or Bayesian updating entering into medical thinking, and unfortunately we haven't seen it translate you much into clinical practice, but we're getting there. But okay, well, one thing I hear a lot about is that we've made a ton of progress by teaching endoscopic surgeons to take bigger and bigger bites or use different suture-assisted devices or things like that, and that we've been making all this progress in reducing what once was a very horribly high rate of vaginal cuff dehiscence with endoscopic hysterectomy. But we've reduced it down now to an acceptable level because we've taught better techniques about all these things.
Antonia:Yeah, there's definitely truth to that. We have made a lot of progress from those horrible rates. Historically in the early days of laparoscopic hysterectomy the rates were around 3% in the literature. So everyone in 30 or so patients would require a return to the OR to fix that cuff dehiscence. So to address that, endoscopic surgeons over time have been taught to take larger bites than they think they need to and just realize that the effect of the magnification on their laparoscope is causing them to misjudge the size of the bite they're taking.
Antonia:It's easy to think something is a centimeter, but really it's only about five millimeters because you're so zoomed in it looks like a big distance but it's really a tiny distance. But you've always maintained that despite many of these improvements, there's a limit in how low you can reduce complications of laparoscopic hysterectomy like the cuff dehiscence, because of how the colpotomy is done. So if you're doing everything laparoscopically, you have to use a thermal device to make the colpotomy, which is the vaginal incision that ends up getting sutured back together and that causes a lot more damage to the tissue compared to if you would use a scalpel during vaginal or abdominal hysterectomy. So even the most perfectly sized suture closure is going to have less healthy tissue to work with and more risk of dehiscence right.
Howard:Yeah Well, there's a new paper in the March 2023 edition of the Journal of Minimally Invasive Gynecology which looks at trends and risk factors for vaginal cuff dehiscence by mode of hysterectomy over time, which should tell us a story of how improvements in techniques and emphasis on this problem helped to make the situation better.
Antonia:All right. What did they find?
Howard:Well, they looked at 4,059 hysterectomies of all routes over an 11-year period at one single facility. So these included abdominal, vaginal, total laparoscopic-assisted vaginal hysterectomies and robotic-assisted hysterectomies. They, of course, excluded super cervical hysterectomies from their data, since there's no cuff to close. Now, overall, the rate of vaginal cuff dehiscence in the study was highest among robotic-assisted hysterectomies, at 0.66%, so way better than 3%, followed by 0.32% risk with total laparoscopic hysterectomies and 0.27% risk with total abdominal hysterectomies. And there were no cuff dehiscences cuff in the laparoscopic-assisted vaginal or in the total vaginal hysterectomies. Interestingly, they emphasized that this demonstrated a much lower rate of cuff to hystinces than was previously reported in the literature, which definitely does, though this is still a relatively rare complication. So they admit that it may be underpowered, but it still looks like there's been an improvement in the rates of cuff to hystinces over time with these improved techniques.
Antonia:Okay. Well, let's go back to the part where they said there were zero dehiscences among the vaginal hysterectomy group and also none in the laparoscopic-assisted vaginal hysterectomy group. That probably shows that the key factor there is how the colpotomies are made. Although they don't verify that every single colpotomy for these cases was done by a cold knife, some people even will use a Bovie at TVH, but it's reasonable to assume that most of them probably were done by scalpel and not by energy.
Howard:Yeah, I do think that the authors bury the lead here in focusing on the reduction in the rates of the endoscopic hysterectomies, because the story is there were none, as you said, with the vaginal hysterectomies or the laparoscopic-assisted vaginal hysterectomies. I definitely think that if you make the colpotomy with a cold knife, as you do at vaginal hysterectomy, that you'll have better tissue healing and a lower rate of dehiscence than if you make it with an energy device. This has been well enough established. I think now for a while that we can consider it just a fact. In over a thousand vaginal hysterectomies that I've performed or assisted, I've never seen a cuff dehiscence. But I think vaginal surgeons, for the same reason, should avoid, as you said, using the Bovie to make their colpotomies.
Howard:Now there are other differences than what tool you use for the colpotomy. In both vaginal hysterectomy and laparoscopic-assisted vaginal hysterectomy, the vaginal cuff is closed by hand, directly from below, and this may still result in better bites than a closure made using a camera and laparoscopic tools coming from above. Or they also had a men abdominal hysterectomies and the same thing you're fighting for exposure deep in the pelvis. You think you got the edge of it. It's hard to see. Well, it's easy to see vaginally.
Howard:But I don't believe that I take necessarily bigger bites in vaginal hysterectomy than endoscopic surgeons do today, at least after being retrained. In fact, I think they take bigger bites than I do. So I really do think this comes down to the use of an energy device, which is just a limiting step in this procedure. It really is quite interesting why the technique of laparoscopic hysterectomy doesn't just encourage doing the colpotomies and the closure is vaginally, in other words, a laparoscopic-assisted vaginal hysterectomy. It would be much cheaper, safer for the patient, faster in many cases. But I think the industry has promoted the total laparoscopic approach, particularly when using the robot, especially with the colpotomizers, the suture cyst devices, all these things that you need to buy if you're going to do a total endoscopic approach, that you don't need if you're doing a laparoscopic-assisted vaginal hysterectomy.
Antonia:Yeah, I agree with that. It seems like there's so many products that cater and encourage people doing hysterectomies to do them fully laparoscopically and not partially laparoscopically, and I haven't seen, for example, a product that's catered around doing a colpotomy from below and then maintaining an airtight seal and then coming above and manipulating the uterus. I do think I have done some V-notes. I think V-notes is starting to change that, although you could also make it work with just using an insulation ring in the vagina, and that would probably still be more airtight than improvising with a sterile glove to keep the air from leaking out. But there aren't any custom fit products that are meant to perfectly make that the most easiest way to do the hysterectomy.
Howard:Well, if you're doing it as a laparoscopic-assisted, you just do the top and you go down and finish at the bottom and close.
Howard:So you don't necessarily need to go back up, and so it's just a different technique. And another fundamental limitation of the endoscopic approach, particularly when you do the lower portion is the increased risk of injury to the ureters, which are pulled in closer to the uterine artery rather than pulled away from them when you descend the uterus with a vaginal hysterectomy. So I think that's the other fundamental thing that endoscopic hysterectomy cannot overcome, right.
Antonia:This study also showed that the trend increased towards minimally invasive hysterectomies. Over their study period, it went from 2010 to 2021. There was a 14 percentage point increase in hysterectomies done by one of those minimally invasive approaches, but overall there was a 35 percent point increase in utilizing the robot, which shows that the robot is eating up the other, less expensive, minimally invasive approaches.
Howard:Yeah, and that's what typically happens. It's true that the total number of minimally invasive hysterectomies are increasing as you see the robot introduced over time. But that was going to happen anyway had there been no robot, as more gynecologists were graduating from residency programs trying to do laparoscopic hysterectomies or, in Howard fantasy land, vaginal hysterectomies. But there's really no evidence that the robot in and of itself has been the driving force of a decrease in open abdominal hysterectomies in the United States, but instead it seems to just be cannibalizing both vaginal and laparoscopic hysterectomies, replacing a minimal hysterectomy with another minimal approach. So this again just shows the influence of industry on our profession.
Antonia:It's interesting that the authors don't even mention how vaginal hysterectomy is really superior in regards to the outcome that they were focusing on. It's almost just taken for granted that we still have to do most of these hysterectomies endoscopically, and we should be proud of ourselves that the robot only has a two third of a percent risk that the woman will have a cuff breakdown and require a second surgery, even when there's already another route that yielded zero cuff breakdowns at least zero in this study. They just overlapped it.
Howard:Well, yeah, that's the trend for literature in general about hysterectomy. The literature overall is consistent over time that vaginal hysterectomy is the best approach for the patient and the route associated with the best outcomes and the lowest risk of re-operation, the lowest cost, etc. Yet the trend is away from it because of many of the reasons that are certainly beyond the scope of this discussion, but industry influence has a lot to do with it.
Antonia:Well, speaking of that, we will have to talk about v-notes at some point. It seems like, at least for some people, it's like an attempt, with the help of industry, to reintroduce vaginal surgery to gynecologists who have some trepidation of operating without a laparoscope or for some reason are averse to doing vaginal hysterectomy. So we'll have a more extensive discussion on it later, I think.
Howard:I think V-notes trumps robot, but at some point you got to take the training wheels off.
Antonia:Yeah, that's fair.
Howard:Okay, well at least V-notes has the ability to overcome those two fundamental differences in terms of how you make the colpotomy and the descending the uterus with the time of ligation of the uterine artery. So there aren't large studies that give fair comparisons, but in the range of less bad, it has to be the less bad one.
Antonia:Yeah, I think later we'll see more head-to-head to the other types of minimally invasive. It's still a little bit too early to say quantitatively and all of that stuff, but we'll come back to it later. But for today we'll wrap up. So the Thinking About OBGYN website will have links to a lot of the things we talked about and then we'll be back in a couple weeks.
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