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Quality and Outcomes Research in Head and Neck Cancer: From Bench to Bedside with Yale Leading the Charge

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Quality and Outcomes Research in Head and Neck Cancer: From Bench to Bedside with Yale Leading the Charge

October 19, 2022

Yale Cancer Center Grand Rounds | October 18, 2022

Presentation by: Dr. Saral Mehra

ID
8178

Transcript

  • 00:00Hi. Welcome everybody.
  • 00:01I'm Barbara burtness. I'm a.
  • 00:03Medical oncologist and work on
  • 00:05head and neck cancer and I'm
  • 00:07really like I could not be more
  • 00:10extraordinarily delighted than I
  • 00:12am to be today presenting Dr Saral
  • 00:15Mera as our grand round speaker.
  • 00:17Doctor Mehra is an associate professor
  • 00:19of surgery in otolaryngology and
  • 00:21Section chief of head and neck surgery.
  • 00:23He received his medical degree from
  • 00:25Columbia University College of
  • 00:27Physicians and Surgeons in New York,
  • 00:29also obtained an MBA there and went
  • 00:31on to residency in Otolaryngology
  • 00:33Head neck surgery at New York
  • 00:35Presbyterian Memorial Sloan Kettering,
  • 00:37and then completed his training with
  • 00:40a extremely coveted fellowship in
  • 00:42head and neck and thyroid cancer
  • 00:44surgery at Mount Sinai,
  • 00:46including Subspecialization in
  • 00:48complex reconstruction.
  • 00:50His clinical practice focuses on
  • 00:52treating patients with head and
  • 00:54neck salivary and thyroid diseases,
  • 00:56particularly those patients who
  • 00:58need a very advanced resection
  • 00:59or advanced reconstruction.
  • 01:01And I've been privileged to share
  • 01:03many hundreds of patients with him.
  • 01:04And I can like very personally say
  • 01:07his oncologic and reconstructive
  • 01:09outcomes are exceptional.
  • 01:11And so his primary research
  • 01:12interest ties in this very nicely
  • 01:14because he focuses on measuring and
  • 01:16improving quality in the treatment
  • 01:17of head neck cancers and I think
  • 01:19one of the central conundrum.
  • 01:21Our field is how do we take exceptional
  • 01:24care and and broaden its accessibility
  • 01:27and broaden its applicability.
  • 01:28So he's going to be talking about
  • 01:30quality and outcomes research and
  • 01:32head neck cancer from bench to
  • 01:34bedside with Yale leading the charge,
  • 01:35Cyril.
  • 01:41Thank you so much for that
  • 01:43introduction Barbara and thank
  • 01:44you everybody for logging in and
  • 01:46and and listening to this talk.
  • 01:48I know it's a diverse group of basic
  • 01:51scientist clinical researchers
  • 01:52and hopefully some outcomes
  • 01:54researchers out there as well.
  • 01:56So that's my topic.
  • 01:59It's been discussed.
  • 02:00Just make sure this is working.
  • 02:14OK, so I have no I have
  • 02:16no financial disclosures,
  • 02:17so I couldn't do a head and neck
  • 02:19research talk without mentioning 2
  • 02:22important studies recently published,
  • 02:24ECOG 3311 and keynote O48,
  • 02:25of which Yale specifically Doctor
  • 02:27Burtness was lead author on both of
  • 02:29these very different types of studies.
  • 02:31But these are practice changing
  • 02:33studies recently published.
  • 02:35Um ECOG 3311 looked at T1 and T2
  • 02:38resectable HPV positive oropharynx
  • 02:41squamous cell carcinoma and
  • 02:44keynote O48 looked at locally
  • 02:45the opposite end of the spectrum,
  • 02:48locally incurable recurrent or metastatic
  • 02:50head neck squamous cell carcinoma.
  • 02:52What I've put up here,
  • 02:54I'm not going into details of these studies,
  • 02:56but what I've put up here are
  • 02:59survival curves from these huge.
  • 03:01Hugely important recent practice
  • 03:03changing studies, OK,
  • 03:04I'm not going to get into details
  • 03:07about these over the next 45 minutes.
  • 03:08What I really want to do though is
  • 03:10convince you of two things and I think
  • 03:12I may have already done the first one
  • 03:14because it doesn't take much convincing.
  • 03:16Large scale multi institutional
  • 03:18randomized control trials are important
  • 03:20and they can lead to practice changing
  • 03:23innovations in the care of cancer patients.
  • 03:26Any cancer, I'm going to put a
  • 03:29check mark beside that already.
  • 03:31Based on that first slide and
  • 03:32which you probably already know,
  • 03:33but really what I want to do
  • 03:35is tell you that the quality,
  • 03:37that quality of care research
  • 03:39or call it what you will,
  • 03:41patient reported outcomes reaches
  • 03:44patient centered outcomes research.
  • 03:47Comparative effectiveness research goes
  • 03:48by different names at different times.
  • 03:51But when you can take this from
  • 03:53the bench to the bedside,
  • 03:55we can have a remarkable impact
  • 03:57on patient outcomes.
  • 03:58And not only that but this type
  • 04:00of research is actually necessary.
  • 04:02For I'll put in quotes the real
  • 04:04science to mean anything.
  • 04:06That's the basic scientist,
  • 04:08the clinical trials.
  • 04:10That's what I want to convince you of.
  • 04:11By the end of this talk,
  • 04:13I'm going to start with a case.
  • 04:15This is a 52 year old man.
  • 04:16This is actually very recent.
  • 04:20And within our system,
  • 04:21OK, the very recent case,
  • 04:2352 year old man never smoker 2.9
  • 04:26centimeter right neck mass and a
  • 04:28right tonsil mass was seen in our
  • 04:31system and had a right tonsil mass.
  • 04:33Biopsy showed poorly differentiated
  • 04:35squamous cell carcinoma and the P-16
  • 04:38stain was strongly and diffusely positive.
  • 04:41The patient went for surgery.
  • 04:45And what the pathology identified with
  • 04:47the tonsillectomy and a neck mass
  • 04:49excision was a P-16 positive cancer,
  • 04:523 centimeters extending to the
  • 04:54margins of resection and a 2.7
  • 04:57centimeter node with no ENE.
  • 05:01And a few other nodes also that
  • 05:03that came with the specimen.
  • 05:04So this patient was then referred
  • 05:06for radiation and chemotherapy.
  • 05:07There's a positive margin.
  • 05:10The guidelines say radiation
  • 05:12chemotherapy was then re referred
  • 05:15to but by care center physician
  • 05:18to the head neck disease team at
  • 05:20the at at the Big House.
  • 05:22And this was interesting because
  • 05:24a few things first of all was
  • 05:26staging completed prior to treatment
  • 05:27was one of
  • 05:28the questions that came up
  • 05:30when they were discussed.
  • 05:31And the answer was no.
  • 05:32And then more important was the
  • 05:35latest science applied to this patient
  • 05:38ECOG 3311 had already come out.
  • 05:39I told you this is a very
  • 05:42recent case and preoperatively
  • 05:43pre surgery this patient will
  • 05:44be in the low risk category of
  • 05:48T1N1 cancer where we
  • 05:52could potentially operate.
  • 05:54And go to observation, no radiation,
  • 05:56no chemotherapy and this patient
  • 05:58have a 94% progression free survival
  • 06:00based on the data from ECOG 3311.
  • 06:03But now this patient has a positive margin.
  • 06:06Now he's in the high risk category
  • 06:08and now he technically should go
  • 06:11on to chemotherapy and radiation.
  • 06:13Nothing about this tumor change,
  • 06:15nothing about the patient changed,
  • 06:16about the biology changed,
  • 06:18but now the treatment recommendation
  • 06:21could be different.
  • 06:22So we had a long discussion in tumor board.
  • 06:25And what we decided to do after
  • 06:27multidisciplinary team care was complete,
  • 06:29the staging taken for transoral
  • 06:32robotic surgery to clear that margin
  • 06:34and do a formal neck dissection.
  • 06:37Unfortunately,
  • 06:37this patient did have to escalate
  • 06:39after a discussion,
  • 06:40we did decide to escalate his therapy
  • 06:43to radiation because of the original
  • 06:45positive margin and discussing the
  • 06:47risks and benefits with the patient.
  • 06:50Controversial,
  • 06:50but that's what we decided to do.
  • 06:53OK. So that's my case.
  • 06:55Some kind of frames,
  • 06:56this discussion,
  • 06:57so some background and definitions.
  • 06:59What is quality in cancer care?
  • 07:01I'm not going to read all these,
  • 07:03but if you look at some of the literature
  • 07:06on quality and cancer care nationally,
  • 07:09they have all these fancy definitions.
  • 07:11But this is what I think is just,
  • 07:13it's so simple,
  • 07:13so simple and you all know this already,
  • 07:15I know, but it's just getting the
  • 07:17right care to the right patient at
  • 07:20the right time and doing it every time.
  • 07:22That's it, that's quality.
  • 07:24In healthcare,
  • 07:25especially cancer care.
  • 07:26So what went wrong with this patient?
  • 07:29This patient is going to do fine.
  • 07:30The survival rate still 90% plus,
  • 07:33you know,
  • 07:33it wasn't technically harmed other
  • 07:35than treatment and functionally
  • 07:37and maybe some side effects,
  • 07:39but he's going to live,
  • 07:40he's going to have a good outcome.
  • 07:42But,
  • 07:42but I would argue this wasn't the
  • 07:45highest quality of care and it
  • 07:47wasn't applying the latest science.
  • 07:49So if anyone here has been
  • 07:51to Business School,
  • 07:53you would have read a lot
  • 07:55about Edward Edwards Deming,
  • 07:57who created basically the Toyota,
  • 08:00Toyota Quality Improvement
  • 08:01process and brought you know,
  • 08:04car production to the
  • 08:05highest quality in Japan.
  • 08:07And I think he said it best and
  • 08:09it really applies to cancer care.
  • 08:12What the fault in the interpretation
  • 08:14of observations seen everywhere
  • 08:16is just suppose that every event,
  • 08:18any defective mistake and accident
  • 08:20is attributable to someone,
  • 08:22usually whoever's closest at hand or
  • 08:25some special extraordinary event.
  • 08:28But the fact is,
  • 08:28it's not the people that are the issues,
  • 08:30it's the system that doesn't work
  • 08:32when there's errors and mistakes.
  • 08:34The Institute of Medicine,
  • 08:36in their crossing the Quality Chasm report,
  • 08:39said it well that poor quality care
  • 08:41occurs not because of a failure of
  • 08:44goodwill or knowledge or effort or resources,
  • 08:47but because of fundamental shortcomings
  • 08:48in the way cancer care is organized.
  • 08:51There's no there's no bad doctor,
  • 08:53there's no one who wants to harm a patient.
  • 08:55That I know of at least.
  • 08:57But the system can be the problem.
  • 09:01So how do we measure quality?
  • 09:02There's really three ways what a
  • 09:04lot of us do, and what was done
  • 09:07all the time, many years ago,
  • 09:10was implicit or expert review.
  • 09:13I'm in an ivory tower.
  • 09:14I say it's high quality.
  • 09:15I'm. I'm great.
  • 09:16And so it is. That's it.
  • 09:18But there are scientific
  • 09:19ways to measure quality,
  • 09:21specifically structure and process metrics.
  • 09:26So why is structure so important?
  • 09:29Take a moment to talk about this.
  • 09:31So right now,
  • 09:32I'm sure you can all recognize the
  • 09:34organization of cancer care most of the US,
  • 09:36the patient at least in the middle,
  • 09:39and then doctors all around them
  • 09:41and communication can be very,
  • 09:42very challenging.
  • 09:43This happens to be from a publication.
  • 09:44And regarding thyroid cancer cares,
  • 09:46we've got nuclear medicine specialists,
  • 09:48we've got radiologists,
  • 09:49we've got endocrinologist,
  • 09:50medical oncologists and the patients.
  • 09:54Left in the middle and can be quite confused.
  • 09:58This is the structure of hospital
  • 10:00care in the United States.
  • 10:02There's about 6000 hospitals
  • 10:04registered in the United States.
  • 10:06About 1500 of them are registered by
  • 10:09the ACS Commission on Cancer and about
  • 10:1371% are treated at ACS Commission
  • 10:16on cancer accredited hospitals.
  • 10:20And I'm sure you've heard of SEER,
  • 10:21which is a representative national database
  • 10:24and that captures about 14% of cancer cases,
  • 10:27but is supposed to be and probably
  • 10:30is representative of cancer care
  • 10:32within the country.
  • 10:33So you can get incidence rates from Seer,
  • 10:35where you can't get that from NCDB,
  • 10:37which is a,
  • 10:38which is the Commission on cancer data set.
  • 10:42There's a number of
  • 10:43comprehensive cancer centers,
  • 10:44there's cancer centers,
  • 10:46there's community cancer centers,
  • 10:47all designated by the NCI.
  • 10:49And I tried to find how many surgeons
  • 10:51or medical oncologist radiation
  • 10:53oncologists treat head and neck cancer.
  • 10:55As you could guess,
  • 10:57it's pretty much impossible to find that.
  • 10:59So the organization of US cancer
  • 11:02cases so diffuse diverse that
  • 11:04providers have not you as a provider,
  • 11:06if you are a doctor,
  • 11:07have not had to provide accountability
  • 11:10for specific processes or outcomes for
  • 11:13you specifically or at your center.
  • 11:16OK, so now let's get into some research,
  • 11:18research and cancer quality
  • 11:20that that's my background.
  • 11:21So my research journey at Yale
  • 11:25really is about quality of care,
  • 11:28patient centers, out centered outcomes.
  • 11:30And what I'm trying to do now is
  • 11:33my version of bench to bedside.
  • 11:35So how do we take the science in outcomes
  • 11:38research and apply it to patients?
  • 11:40It's really not just fluff.
  • 11:41I know there's real quote real
  • 11:44scientists out there, basic scientists.
  • 11:46Huge randomized control types
  • 11:49of signs is out there.
  • 11:50I think this is real and going
  • 11:52to try and convince you of that.
  • 11:54So my foray into patient centered
  • 11:56outcomes research started in fellowship
  • 11:58and these republished in my first
  • 12:00year being here some pretty large
  • 12:02reviews on thyroid cancer care and
  • 12:04how can we measure and improve thyroid
  • 12:06cancer care across the country.
  • 12:08And I reviewed all the databases
  • 12:11for thyroid cancer and
  • 12:12published these in thyroid with
  • 12:14a nice team of colleagues.
  • 12:16Um, kind of around the country
  • 12:18and thyroid cancer care.
  • 12:19When I got to Yale, I saw,
  • 12:21Oh my God, there's actually a
  • 12:22lot of people doing this stuff.
  • 12:23People like Dan BofA and Ben Judson,
  • 12:26who and and Kerry Gross,
  • 12:28who were really nationally known
  • 12:30in quality of cancer care research,
  • 12:32two of them being surgeons through
  • 12:34basic and head and neck surgeons.
  • 12:37So what I wanted to do first was,
  • 12:38well, how are we doing it, Yale?
  • 12:40I mean, are we delivering quality
  • 12:43care at Yale? I had no idea.
  • 12:45Nobody had any idea. Yes.
  • 12:46Many of these are even Dan and Ben.
  • 12:48And you asked them,
  • 12:49hey, how's your quality,
  • 12:50how's your divisions quality,
  • 12:51what's your margin rate,
  • 12:53survival rates for different cancers,
  • 12:55nobody had any idea.
  • 12:57So I tried,
  • 12:58I tried to figure this out and I
  • 12:59created a head neck scorecard using
  • 13:01some of the science and outcomes research.
  • 13:03We had structural metrics.
  • 13:05We had process metrics, pretreatment,
  • 13:07treatment post treatment and then
  • 13:08of course outcomes, oncologic,
  • 13:10functional and patient reported
  • 13:12outcome metrics.
  • 13:13We created this big scorecard,
  • 13:14reviewed all the registry data over.
  • 13:16A few years divided things into
  • 13:19surgical outcomes, medical outcomes.
  • 13:21I'm not going into the details of this,
  • 13:23and what I found was that it was
  • 13:26actually hard to get the data.
  • 13:30And 2nd,
  • 13:31we didn't really have national
  • 13:32benchmarks upon which to compare our
  • 13:35data with the country as a whole.
  • 13:37We were sort of in the realm of expert
  • 13:40opinion to say how we were doing.
  • 13:45So it was under that idea that I began
  • 13:47the first stage of research in measuring
  • 13:50quality and head and neck cancer.
  • 13:53So these were some of the
  • 13:55areas of interest that I had.
  • 13:57I started first with volumes and outcomes,
  • 14:00a structural metric. I didn't spend
  • 14:02much too much time here because.
  • 14:06It's been published and researched
  • 14:07and sort of known to death.
  • 14:09Higher volumes lead to better outcomes.
  • 14:12It's been known for years and every aspect,
  • 14:15probably of medicine definitely surges,
  • 14:18definitely surgery.
  • 14:19Here's a few studies published 2009, 2010.
  • 14:23And I was surprised to see even
  • 14:24in this last studies, 2022,
  • 14:26people are still publishing the
  • 14:28volume outcomes relationship studies.
  • 14:30That was pretty well known,
  • 14:31but I didn't want to be left in the lurch.
  • 14:34So I looked at this as well.
  • 14:35I said well, how about.
  • 14:36I tried to look at Connecticut.
  • 14:38Turns out the NCDB won't give you
  • 14:39the data for Connecticut because
  • 14:40there's not that many hospitals
  • 14:42and you could probably identify
  • 14:43which hospital is which one of you
  • 14:45were trying to do the research.
  • 14:47For example,
  • 14:47I don't think there's too many
  • 14:49hospitals in Connecticut that do 200.
  • 14:51Analytic head and neck cancer cases,
  • 14:54but I was able to get New England data
  • 14:56and so we looked at data for upper
  • 15:00aerodigestive tract cancers and we
  • 15:02looked at average case volume by hospital,
  • 15:04which was about 26 cases per year with a
  • 15:09range of 1 case to 213 cases per year.
  • 15:12And we did our standard multivariate
  • 15:14analysis controlling for age,
  • 15:16stage grade,
  • 15:17comorbidity,
  • 15:18insurance status and we found that
  • 15:20worse survival was associated with.
  • 15:23Treatments at a facility seeing
  • 15:25less than 50 cases per year compared
  • 15:27to greater than 50 cases,
  • 15:28a pretty pretty impressive hazard ratio.
  • 15:32Not new, not novel. But I wanted to know.
  • 15:35I'm Canadian. I'm in New England.
  • 15:36How are we doing?
  • 15:38And that that gave me the the answer.
  • 15:41So then I went on to a series of studies
  • 15:43looking at timeliness in cancer care.
  • 15:44So why is timeliness important?
  • 15:46Well,
  • 15:47timely diagnosis and treatment is
  • 15:49associated with improved perceived quality
  • 15:52of care and lower patient anxiety.
  • 15:54So that's important.
  • 15:55And then one could say that
  • 15:58assuming the disease progresses
  • 16:00while waiting for treatment,
  • 16:02delays may result in more extensive
  • 16:04treatment and possibly increased costs.
  • 16:07And 3rd,
  • 16:07the impact of treatment
  • 16:09timeliness for cancer on true.
  • 16:11Health outcomes like patient
  • 16:13reported outcomes,
  • 16:14functional outcomes,
  • 16:15even survival a little bit less clear
  • 16:17and this is going back you know 10 or 15,
  • 16:19about 10 years when I was
  • 16:21doing this research originally.
  • 16:22So we started a number of studies.
  • 16:24First we looked at treatment
  • 16:26delays in oral cavity,
  • 16:27squamous cell cancer across the country.
  • 16:30We had three objectives in this
  • 16:32study and this study was presented
  • 16:33at the American Head Neck Society
  • 16:35meeting as one of the best papers
  • 16:37at the meeting and we looked at
  • 16:39national trends in treatment time.
  • 16:41Tables in patients with oral cavity cancer.
  • 16:43So just get some benchmarks.
  • 16:45How is the country doing?
  • 16:47How can we know how we're doing at
  • 16:48Yale or you're doing wherever you are?
  • 16:50If we don't know what a benchmark is,
  • 16:53then we wanted to identify factors
  • 16:55associated with extended treatment
  • 16:57time intervals and then to determine
  • 16:59if delays in treatment intervals
  • 17:01were associated with survival.
  • 17:02These last two were more secondary outcomes.
  • 17:04Really my main purpose of this was
  • 17:06just to see how is the country doing.
  • 17:09So we went through our standard.
  • 17:11Inclusion exclusion criteria of
  • 17:13oral cavity squamous cell carcinoma
  • 17:15treated over a 14 year period using
  • 17:17the National Cancer database and
  • 17:19ended with about 6000 patients in the
  • 17:21final cohort with oral cavity cancer.
  • 17:23These are the time intervals that
  • 17:26we measured diagnosis to surgery was
  • 17:29diagnosis to treatment initiation.
  • 17:31Surgery to RT start was what it says
  • 17:33and then RT start to RT radiation
  • 17:36start to radiation end was was at
  • 17:38its was as it says and then we had
  • 17:40total treatment package which is
  • 17:42from when you started treatment to
  • 17:44ending treatment and then diagnosis
  • 17:46to treatment ends.
  • 17:47So these are these are the intervals
  • 17:49that we used and this is what we found.
  • 17:53These are box plots you can hear
  • 17:55you see huge variation across the
  • 17:57country in every single one of
  • 18:00these treatment intervals.
  • 18:02As a quality researcher,
  • 18:03if you are when you'll know,
  • 18:04or any researcher really would know,
  • 18:06that the wider these box plots,
  • 18:09the greater variation and a huge
  • 18:11opportunity for quality improvement
  • 18:13is to shrink these box plots.
  • 18:16We looked at survival.
  • 18:18Again, secondary outcome,
  • 18:20probably not the best database
  • 18:22to look at survival.
  • 18:23Plus we only had overall survival.
  • 18:26What we found was that radiation
  • 18:28duration if you were in the median
  • 18:30or below versus the 4th quartile was
  • 18:32significantly associated with worse survival,
  • 18:35meaning treatment breaks during radiation.
  • 18:37Not new,
  • 18:38not novel but but that's what we found.
  • 18:40And look at this survival curve.
  • 18:42This is RT duration.
  • 18:44You compare this to the ECOG 3311
  • 18:47and the keynote O48 survival curves,
  • 18:49which I flashed up there.
  • 18:50I think this is a little bit more impressive.
  • 18:53Not as great a study but so many
  • 18:56more problems with it but I just do
  • 18:59that for a visualization and these
  • 19:01were this is what I thought was more
  • 19:03more interesting though was the now
  • 19:06finally we had time intervals across
  • 19:08the country at NCNC DBCC accredited
  • 19:11hospitals for for median times to
  • 19:14treatment and and this is what we're at.
  • 19:17We did this a lot and we did
  • 19:19it for oral cavity.
  • 19:20We did it for oral pharynx
  • 19:22treated with surgery.
  • 19:23We did it with oropharynx
  • 19:27treated nonsurgically.
  • 19:28We did it for hypopharynx cancer.
  • 19:31Did it for salivary cancer and
  • 19:34we established benchmarks.
  • 19:35We we had box plots for all of these.
  • 19:37We looked at survival outcomes
  • 19:39for all of these.
  • 19:40So I told you about oral cavity already.
  • 19:42Here's oral pharynx,
  • 19:43look at the the wide variety in
  • 19:45the whole huge variation in treatment for
  • 19:48oral fairness cancer treated surgically.
  • 19:50Here's a survival curve.
  • 19:52This was diagnosis to treatment end.
  • 19:54We're seeing big differences if you were
  • 19:57delayed versus not delayed and this was
  • 19:59the same for oral pharynx cancer treated.
  • 20:01Nonsurgically multivariate analysis
  • 20:03controlling for all the standard factors
  • 20:06that we always control for hypopharynx,
  • 20:09cancer, salivary cancer, it goes on.
  • 20:11So my point here is that analysis of
  • 20:14variation in treatment time intervals really
  • 20:17can identify opportunities for us to improve.
  • 20:212nd, we found that there's a number
  • 20:23of factors associated with delays.
  • 20:24I didn't show you that that data here,
  • 20:27but these can also are are often related
  • 20:31to access and coordination of care.
  • 20:33And so the third finding here was that
  • 20:36every effort should be made to prevent
  • 20:38prevent radiation treatment breaks,
  • 20:40because in every single one of those
  • 20:42there was a significant association
  • 20:44with overall survival,
  • 20:45meaning worse if you had treatment
  • 20:48breaks or extended radiation.
  • 20:49And this matters to patients, too.
  • 20:51Here's a patient with an oral cavity cancer
  • 20:54diagnosed elsewhere delayed getting in,
  • 20:57starting with an oral cavity cancer,
  • 20:59but eventually,
  • 20:59when he came to treatment,
  • 21:01extending through his skin,
  • 21:04through the mandible.
  • 21:06Original CT scan,
  • 21:07no mandible invasion and here we are
  • 21:10taking this cancer out mandibulectomy
  • 21:13composite SO4 mouth mandible skin,
  • 21:16using the fibula to reconstruct
  • 21:18with a plate and using the skin
  • 21:21on the outside to reconstruct so.
  • 21:24Cancer is out, but at what cost?
  • 21:26Because of delay in diagnosis,
  • 21:29delay in treatment,
  • 21:29delay in diagnosis is a whole
  • 21:31other discussion,
  • 21:32which I don't talk about and
  • 21:35I don't really study.
  • 21:39The Commission on cancer has
  • 21:41just in March of this year,
  • 21:44very recently finally put in their
  • 21:45first head and neck oncology quality
  • 21:48metric that's going to be measured at
  • 21:50every single ACS accredited hospital
  • 21:52across the country and that's time to
  • 21:55initiation of post operative radiation.
  • 21:57This my study didn't really
  • 21:59show much of an association.
  • 22:01There's tons of studies focused using
  • 22:03that as their primary outcome that
  • 22:05have shown that 42 weeks, 42 days.
  • 22:07Is a big cut off to affect survival to start
  • 22:10radiation after head and neck cancer surgery.
  • 22:13So this is a new quality metric
  • 22:15that we're all being measured on,
  • 22:16just so you know. OK.
  • 22:19So then did volume outcomes,
  • 22:22did timeliness.
  • 22:23So then I wanted to look at surgical quality.
  • 22:25How do we measure that?
  • 22:26How do we benchmark this?
  • 22:27How do I know if I'm doing a good job?
  • 22:29And so we started looking
  • 22:31at a number of things.
  • 22:32So this was Ben Judson
  • 22:33was a lead author on this,
  • 22:34but our whole team was involved
  • 22:36where we look, tried to identify.
  • 22:39Thresholds for lymph node yields.
  • 22:42For oral cavity cancer,
  • 22:43so our objective in this study was to
  • 22:46determine lymph node yield threshold
  • 22:48and oral cavity squamous cell
  • 22:49cancer that might impact survival.
  • 22:51This was a very interesting study because
  • 22:55we used the NCDB to establish those
  • 22:58yields and then validated it in SEER.
  • 23:01And.
  • 23:02To find the threshold,
  • 23:04we looked at the clinically end zero oral
  • 23:07cavity cancers versus the clinically
  • 23:10and positive oral cavity cancers.
  • 23:12And.
  • 23:15Looked at different.
  • 23:18Hazard ratios based on number of
  • 23:20the lymph node yield basically and
  • 23:23after regressive statistical models,
  • 23:25we basically eventually found
  • 23:27that there was a difference at
  • 23:2916 lymph nodes for N0 neck N,
  • 23:310 lymph node yields and 26
  • 23:34for and positive lymph nodes.
  • 23:36And after adjusting for all sorts of factors,
  • 23:39we found a survival benefit,
  • 23:41overall survival and cause specific
  • 23:42survival based on lymph node yields.
  • 23:45This is using SEER data so
  • 23:46we finally had disease.
  • 23:48Specific survival,
  • 23:48which we don't have in NCDB.
  • 23:50So again,
  • 23:51if you look at these survival curves,
  • 23:53I think they're quite.
  • 23:56Not provoking.
  • 23:58This study came out at the exact
  • 24:00same maybe like a three months
  • 24:02after our study and this looked
  • 24:04at all of head neck cancer and it
  • 24:06looked at used 18 lymph nodes,
  • 24:08so kind of an arbitrary number they picked.
  • 24:10To be honest based on some other
  • 24:12single institution studies they
  • 24:14didn't use the same statistical
  • 24:15rigor that we use in oral cavity
  • 24:17but it applied to all head neck
  • 24:18cancer and so it was more applicable
  • 24:20in 18 has become the big number
  • 24:22for head and neck cancer partly
  • 24:24based on this study but again.
  • 24:26Think what you will just have a #18
  • 24:29lymph nodes. Big survival difference.
  • 24:32So that's lymph node yield.
  • 24:33Then we wanted to look at positive
  • 24:35margin rates and this is another
  • 24:37study that we did trying to
  • 24:38again figure out positive margin
  • 24:40rates in this country for oral
  • 24:41cavity, squamous cell cancer,
  • 24:43what is the baseline?
  • 24:45And again we found incidence of
  • 24:47positive margins based on this study
  • 24:49and we did look at the volume outcomes
  • 24:52relationship and the facility setting.
  • 24:54And if you were to academic center,
  • 24:55your risk of having positive
  • 24:57margins was significantly less.
  • 24:5920 cases seem to be a good threshold,
  • 25:01but again you see a lot of variety.
  • 25:03Variation across the country.
  • 25:05We also looked at transoral robotic surgery.
  • 25:09So the transoral robotic surgery is FDA
  • 25:12approved for T1T2 oropharynx cancers.
  • 25:14And what I wanted to know was well
  • 25:18what is the positive margin rate
  • 25:21nationally and then what factors are
  • 25:23associated with positive margin.
  • 25:24So we did our standard inclusion
  • 25:26exclusion criteria.
  • 25:27We found about 2600 patients who
  • 25:29had a transoral robotic surgery for
  • 25:31oropharynx squamous cell carcinoma
  • 25:33and what did we find overall.
  • 25:36A 17% positive margin rate in this
  • 25:38country and it varied by T stage
  • 25:43T1T2T3T4. You can see that all here.
  • 25:47We also found factors
  • 25:48associated with positive margin,
  • 25:49specifically Lymphovascular invasion,
  • 25:51T classification and again facility
  • 25:54volume of patients treated at high
  • 25:56volume centers were less likely to have.
  • 25:59Positive margin,
  • 26:00you can see academic centers versus
  • 26:03non academic and high volume versus
  • 26:06high volume versus low volume.
  • 26:08So in the, this is interesting because
  • 26:11in the year since FDA approval,
  • 26:13what we found is that the positive
  • 26:15margin rate for towards the 17%.
  • 26:16But if you look at the ECOG 3311 trial,
  • 26:20the positive margin rate of
  • 26:22credentials academic surgeons was 3.3%.
  • 26:25And if you look at pooled data
  • 26:28from 3 clinical trials looking at
  • 26:31academic single institution studies
  • 26:32or even a systematic reviews,
  • 26:34we're looking at significantly
  • 26:36less than the real world.
  • 26:38Positive margin rate,
  • 26:39so there is and then this study
  • 26:42also showed a linear association
  • 26:45between positive margins with T32
  • 26:47and T4 tumors greater than 28%.
  • 26:50So these patients are the ones that
  • 26:52are going on to chemotherapy and
  • 26:54radiation and probably had no benefit
  • 26:57from transoral robotic surgery based
  • 26:59on their current treatment paradigms.
  • 27:01We did this for parotid cancer,
  • 27:03I won't get into those details.
  • 27:05And then this is a interesting
  • 27:07study that combined margin rates
  • 27:09nationally and lymph node yields and
  • 27:12what they looked at was treatment at
  • 27:15the try identify that the treatment
  • 27:17at hospitals that attain a high
  • 27:19rate of negative margins.
  • 27:20So if you're if you have if you're
  • 27:22a hospital that's that's high rate
  • 27:24of negative margins and lymph
  • 27:25node yields of more than 18.
  • 27:27They found that there is a
  • 27:29significant association with
  • 27:30improved survival if you did.
  • 27:31Both of those and these predicted
  • 27:33outcomes independent of those generally
  • 27:35modifiable characteristics including
  • 27:37the volume outcomes relationship.
  • 27:40These were independents of volume of
  • 27:43the hospital but only 105 hospitals
  • 27:46out of 1000 in in the country achieve
  • 27:50negative margins in 90% or more patients and.
  • 27:57If you look at lymph node yields
  • 27:58of greater than 18,
  • 27:59only 199 hospitals out of 1000 consistently
  • 28:05achieved lymph node yields of 18 or more,
  • 28:08meaning in an 80% or more of that's the case.
  • 28:10We're not looking for 100%,
  • 28:11you know,
  • 28:1280% of cases having 18 or more lymph nodes.
  • 28:16So in contrast to the traditional emphasis
  • 28:18on the volume outcomes relationship,
  • 28:20this showed that negative margins
  • 28:22and lymph node yields can actually
  • 28:24neutralize the effect of hospital volume.
  • 28:29OK. So then another area that I want
  • 28:31to look into was guideline adherence
  • 28:33and this it came up because of a study
  • 28:36published in 2009 from MD Anderson.
  • 28:39They looked at 107 patients who came
  • 28:42to them for second opinions with
  • 28:44persistent or recurrent disease.
  • 28:46So they've been treated elsewhere.
  • 28:47They had persistent or recurrent disease and
  • 28:50they wanted to look at well what's going on.
  • 28:52What they found was that 43% of
  • 28:54patients had NCCN guideline non
  • 28:56compliance is the term that they used.
  • 28:59And they try to find some
  • 29:00factor associated with it,
  • 29:02even the specific referring physician,
  • 29:04the type of physician,
  • 29:05the subset of disease,
  • 29:06insurance status, age, sex.
  • 29:07And there was nothing that was
  • 29:10significantly associated with why someone
  • 29:12would get NCCN noncompliant treatment.
  • 29:15So I'm in the same vein.
  • 29:18As you can see my theme here is,
  • 29:20well, how's the country doing?
  • 29:21You know we know how single institutions
  • 29:23are doing, but how about the country?
  • 29:24What's the benchmark?
  • 29:25What are we aiming for?
  • 29:27So we undertook a study to look
  • 29:30at national NCCN guideline,
  • 29:32not non adherence rates.
  • 29:33That was the main objective.
  • 29:35We also wanted to look at associations
  • 29:38between non adherence and survival.
  • 29:40In head neck cancer,
  • 29:41we wanted to look at reasons,
  • 29:43reasons for non non adherence
  • 29:45and then factors associated with
  • 29:47non adherence as secondary aims.
  • 29:49So this is our we started with 375,000
  • 29:54patients treated from 2004 to 2013.
  • 29:58And we tried to figure out which ones
  • 30:00were not adhering and which ones
  • 30:02were adherent to NCCN guidelines
  • 30:04and not going into the details.
  • 30:06This is how we define non adherence by site.
  • 30:09It's just look at the NCCN guidelines.
  • 30:11It's actually pretty easy and they
  • 30:14were surprisingly consistent in
  • 30:15all these areas throughout the
  • 30:17entire years of the study.
  • 30:19We've got the guidelines going back to when
  • 30:22this study started actually from the NCCN.
  • 30:25And these are the numbers.
  • 30:26So if you go to 2004 non adherence
  • 30:28rates throughout this country,
  • 30:30it was 30% for head and neck
  • 30:32squamous cell carcinoma by 2013,
  • 30:34we're still looking at almost
  • 30:361/4 of patients are getting non
  • 30:39adherent guideline non adherent
  • 30:41care within this country.
  • 30:43We looked at his by sub site
  • 30:46for oral cavity cancer,
  • 30:4746% of patients are getting non
  • 30:50adherent care and oral pharynx,
  • 30:52much lower hypopharynx,
  • 30:54larynx and sinuses here.
  • 30:57And then we looked at survival.
  • 30:59So if you have non adherent care
  • 31:01versus adherent care to NCCN
  • 31:03guidelines we found a significant
  • 31:05association with overall survival.
  • 31:07Again a multivariate analysis
  • 31:10controlling for all the typical factors.
  • 31:13And then we looked at factors associated
  • 31:15with guideline not adherence,
  • 31:17black race, age over 65,
  • 31:19comorbidity, non private insurance,
  • 31:21higher T stage and then being
  • 31:24treated and non academic facility.
  • 31:27So I like this quote because it
  • 31:30really talks about highlights why
  • 31:32this is so important when clinicians,
  • 31:34clinicians already know the information
  • 31:36contained in guidelines and this
  • 31:38was years ago, this was 1999,
  • 31:40now they're so accessible.
  • 31:41So I'm going to extend this to
  • 31:42say when physical clinicians.
  • 31:43Know how to get the guidelines
  • 31:45within minutes at their fingertips.
  • 31:47Those clinicians who want to improve
  • 31:50quality need to redirect their
  • 31:52efforts to identify the barriers.
  • 31:54It's not knowledge that stand
  • 31:55in the way of behavior change.
  • 31:57So by addressing the barriers that
  • 32:00prevent adherence to NCCN guidelines
  • 32:03and their treatment protocols,
  • 32:05I think there is a great opportunity
  • 32:08for us to improve survival.
  • 32:10I would even say a responsibility.
  • 32:12Final area of research I wanted to look
  • 32:15at and I haven't done much in this yet.
  • 32:17So I'm going to quote a a different
  • 32:20study by Bevin you who's the chair
  • 32:23at Minnesota University of Minnesota
  • 32:25and he was actually a Robert Wood
  • 32:28Johnson scholar here at Yale and very
  • 32:30well known and outcomes research.
  • 32:32And that cancer he just wanted,
  • 32:34this was a spoke to him about his
  • 32:35very controversial study when he
  • 32:37published this because it was within
  • 32:38his own network of patients that
  • 32:40he was seeing looking at patients
  • 32:41who were treated with radiation.
  • 32:43Therapy at the academic center versus
  • 32:45the non academic center and found
  • 32:47significant differences in five
  • 32:48year survival on there were similar
  • 32:50rates of treatment completion,
  • 32:52similar rates of treatment breaks,
  • 32:54more advanced cancers at the academic center.
  • 32:57Multivariate analysis really you
  • 32:59know statistically rigorous study
  • 33:02couldn't say why but there was.
  • 33:05OK.
  • 33:06So the last thing I want to talk
  • 33:08about is really this concept of bench
  • 33:11to bedside for the patient centered
  • 33:13outcomes researcher and that's what
  • 33:15I've been doing over the last year or so.
  • 33:19What I wanted to do now is take all
  • 33:21this national benchmark data we had.
  • 33:23We knew what good quality was or
  • 33:24at least what the standard of care
  • 33:26was across the country.
  • 33:27I said, hey, how,
  • 33:28how is Yale New Haven Health system doing?
  • 33:31And so this is what we did, we looked.
  • 33:36At tumor registry data from Yale,
  • 33:39New Haven Hospital, Bridgeport Hospital,
  • 33:41Greenwich Hospital, L&M and Westerly.
  • 33:43So our entire network and we got
  • 33:45all the analytic oral cavity cases
  • 33:47from 2012 to 2018.
  • 33:48And we looked at a number of
  • 33:50these quality metrics for which we
  • 33:52now had national benchmarks.
  • 33:54And we looked at the positive margin rate.
  • 33:55We looked at lymph node yields
  • 33:58greater than or equal to 16 adherence
  • 34:00rates to NCCN guidelines and time to
  • 34:03adjuvant therapy within six weeks.
  • 34:05So we started with 500 patients
  • 34:07and these were the three groups of
  • 34:09patients that were treated academical
  • 34:11surgery and radiation or all their
  • 34:13treatment if there was no radiation
  • 34:15at the academic only center,
  • 34:16Community Center being the opposite
  • 34:18end and then the combined group.
  • 34:20So they had in this combined group,
  • 34:22it was always surgery at the main
  • 34:24center and radiation elsewhere.
  • 34:25For some reason it didn't go the other way.
  • 34:28And these were our key findings.
  • 34:31There was a higher positive surgical
  • 34:34margin rate within our health
  • 34:36system at the Community hospitals,
  • 34:3812% versus 2.5%.
  • 34:39There was a lower likelihood to
  • 34:41meet that bottom lymph node yield
  • 34:43threshold of 16 lymph nodes and a
  • 34:46neck dissection at the community,
  • 34:4859% versus 90%.
  • 34:49There were decreased rates of
  • 34:51adherence to NCC and guidelines in
  • 34:53other hospitals within our Network,
  • 34:5576 versus 86% and adjuvant radiation
  • 34:58therapy within six weeks it was the same.
  • 35:01If you were all academic or all community,
  • 35:03but if you fragmented your care,
  • 35:05it was significantly less.
  • 35:0722% of patients, when fragmenting their care,
  • 35:10received radiation therapy within six weeks.
  • 35:14So it sounded negative originally,
  • 35:15but then we said, hey, well,
  • 35:16we have national benchmarks.
  • 35:18How are we doing?
  • 35:18It turns out that we're actually
  • 35:19doing pretty good within the system.
  • 35:21The, our numbers are on par with the nation.
  • 35:23We're not any worse than the national
  • 35:26benchmarks in our community hospitals.
  • 35:28If you look at the national positive
  • 35:29margin rates based on our studies,
  • 35:31oral cavity cancer is almost 13%.
  • 35:33Our community partners are 12%.
  • 35:37I mean our academic center is 2.5%.
  • 35:39So that's a significant difference,
  • 35:40but but the system is.
  • 35:44Not doing horrible.
  • 35:46There's a lot of reasons that there could,
  • 35:48you know, there could be differences.
  • 35:50For example, availability of frozen section,
  • 35:52access to advanced reconstructive surgery,
  • 35:54we can get more aggressive on the resection,
  • 35:58constant communication between
  • 35:59pathologists and surgeons,
  • 36:01presence of trainees,
  • 36:02perhaps higher case volumes,
  • 36:04how margins are taken by surgeons or
  • 36:06how they're assessed by pathologists.
  • 36:08Countless reasons this for this,
  • 36:11all theoretical.
  • 36:13The other point about positive margins
  • 36:15other than affecting survival is
  • 36:18that it can often lead to unnecessary
  • 36:20escalation of cares like that oropharynx
  • 36:22cancer case that I showed you.
  • 36:24But in this cohort of patients
  • 36:26within our system,
  • 36:27two patients in the Community only
  • 36:30group received adjuvant chemotherapy
  • 36:32plus radiation for early stage disease.
  • 36:34So stage 1/2 cancer positive margin
  • 36:36went on to chemotherapy and radiation.
  • 36:38There's no LINOP and I in those cases.
  • 36:41And when you look at non adherence rates.
  • 36:44Again nationally for all of cancer,
  • 36:4726% of patients for head neck
  • 36:48cancer nationally are non adherence
  • 36:50with guidelines for oral cancer.
  • 36:52If you'll recall based on our
  • 36:54previous studies,
  • 36:5546% of patients are non adherent
  • 36:57in our community.
  • 36:59Yale New Haven Health System is doing
  • 37:00pretty good when you look at national data,
  • 37:02much better than than the
  • 37:04country for oral cavity cancer.
  • 37:05But if you look at the academic center,
  • 37:07we see a significant difference
  • 37:09and again no one looking for
  • 37:11100% adherence to guidelines,
  • 37:13that's not possible, a lot of reasons,
  • 37:15sometimes you can't.
  • 37:15Adherence to guidelines,
  • 37:17but we're looking to benchmark against
  • 37:19the country and against each other.
  • 37:22So.
  • 37:22We looked at lymph node yields
  • 37:24and this is where things got a
  • 37:26little bit more interesting.
  • 37:27Nationally,
  • 37:27greater than or equal to 16 lymph nodes,
  • 37:3070, we used 18.
  • 37:32That's what we have for national data.
  • 37:3470% of patients have more than 18
  • 37:36lymph nodes in their neck dissections.
  • 37:39In our community,
  • 37:4059% and in the academic center,
  • 37:4290%. And you can see the huge
  • 37:45variation as well everywhere really.
  • 37:48Again, there's multiple reasons for this.
  • 37:49How pathologists count limp,
  • 37:51it's not all surgical related,
  • 37:52how pathologists count lymph nodes,
  • 37:54but maybe also the quality of the
  • 37:56neck dissection and this these
  • 37:58can sell a lot of these can be
  • 38:00modifiable treatment factors.
  • 38:01So in this study,
  • 38:02we found that treatment of oral
  • 38:04cavity cancer at Community facilities
  • 38:06within our system may increase the
  • 38:08likelihood of positive margins,
  • 38:09lower likelihood of adequate lymph
  • 38:11node yields and decrease adherence.
  • 38:12NCCN guidelines.
  • 38:13Not only that, but if you fragment your care,
  • 38:16you can have a lower likelihood
  • 38:19of achieving radiation initiation
  • 38:21within six weeks.
  • 38:22A lot of problems with this study.
  • 38:24I think it's still very informative
  • 38:26and very useful to make us better,
  • 38:28but you know,
  • 38:30data were collected retrospectively.
  • 38:32We found a lot of differences in process
  • 38:34related metrics and other studies
  • 38:36have shown association with survival.
  • 38:39This study in and of itself
  • 38:40did not show that there was
  • 38:41any difference in survival,
  • 38:42definitely not powered for this.
  • 38:44It was not the main outcome and
  • 38:46of course there are socio.
  • 38:47I recognize there are socioeconomic and
  • 38:49other factors that can impact patient
  • 38:52care delivery and confound the results.
  • 38:54For example,
  • 38:55patients who are willing to
  • 38:56travel to the academic centers may
  • 38:58differ systematically from those
  • 38:59who seek care closer to home.
  • 39:04Since then, I'm not going to read all
  • 39:06this and tell you this is historic
  • 39:08data going back to 2012 to 2018.
  • 39:11Smilo has, I think, been aware of this.
  • 39:13The leadership has been aware of
  • 39:15this and there's been a lot of
  • 39:17things that have changed to improve
  • 39:18quality even in the last five years.
  • 39:20And I'd love to do this study and I
  • 39:21will do the study a few years from now
  • 39:23as well and see how much better we are.
  • 39:25For example, oncology care pathways
  • 39:27have been initiated.
  • 39:28Community hospitals and disease teams
  • 39:31have been better integrated at SMILOW.
  • 39:34We are creating local disease teams,
  • 39:36experts at community hospitals primarily
  • 39:39dedicated to head and neck cancer care.
  • 39:42Physicians at the academic Center have
  • 39:45established clinics in surrounding
  • 39:46care centers.
  • 39:47We're trying to bring culture from
  • 39:50one place to another as well and
  • 39:53better integrating and aligning
  • 39:54culture across our care centers.
  • 39:57Of course,
  • 39:57advancement in ER has helped a lot.
  • 39:59This is going back to 2012
  • 40:01when the ER was first.
  • 40:03Initiated in the health system,
  • 40:06we have more clinical trials and
  • 40:08they're offered at care centers
  • 40:09and there's a lot of other
  • 40:11improvements that are ongoing.
  • 40:13And I think delivering high quality
  • 40:15care across the system for head and
  • 40:17neck cancer is an important part of
  • 40:20our systems growth and integration.
  • 40:24So really what I think is that integrated
  • 40:26health systems can leverage the strength
  • 40:28of the academic center to figure out
  • 40:31a way to disseminate best practices,
  • 40:33to break those structural barriers
  • 40:35within our network, to improve patient
  • 40:37care and bring high quality care,
  • 40:38whether it's closer to home
  • 40:40or bring the patients here.
  • 40:41But we can do this and dare I say
  • 40:43we have a responsibility to do this,
  • 40:45but how are we going to overcome
  • 40:48these structural barriers?
  • 40:49So bringing it back to the patient.
  • 40:52You know, processing,
  • 40:53quality care improves survival.
  • 40:54I told you that.
  • 40:56But quality care.
  • 40:57It means more than just the
  • 41:00process of care and survival.
  • 41:02It means more than just being cancer free.
  • 41:07Say
  • 41:091234512345. Left and right.
  • 41:13Just to the outside.
  • 41:17Hi, this is **** Morris.
  • 41:19You may have seen me on some of
  • 41:21my Facebook or Internet posts.
  • 41:23I had tongue cancer and doctor Mayer.
  • 41:27Doctor Mehra operated and after
  • 41:29the portion of the tongue that was
  • 41:33cancerous was removed, he replaced
  • 41:35it with a skin graft from my forearm.
  • 41:39I'm now speaking to you 5 weeks to
  • 41:41the day after surgery and I no longer
  • 41:44feel like I have marbles in my mouth.
  • 41:47I can speak clearly and
  • 41:50it's entirely due to him.
  • 41:52Yeah, Mike, partial Larry.
  • 41:54Mack Larnax, see perfect was four months ago.
  • 42:00And.
  • 42:02I'm amazed that I have this voice.
  • 42:06Go
  • 42:101234567. Do you have a feeding tube?
  • 42:13No. Do you have a tracheotomy? No.
  • 42:18Ohh, I had my surgery three months ago.
  • 42:25Free **** pie,
  • 42:27I had my surgery
  • 42:29on May 2nd by Doctor Merritt.
  • 42:31So you can see these are patients
  • 42:33who where function is important.
  • 42:35It's not just that they're alive
  • 42:37and they're cancer free and they
  • 42:39had guideline compliant care,
  • 42:40but you have a laryngectomy patient
  • 42:42speaking hands free thanks to our
  • 42:44speech and language pathologist.
  • 42:45You've got patients who are in the
  • 42:47public speaking after having significant
  • 42:49portions of their tongue removed,
  • 42:52but high quality reconstructions.
  • 42:54Partial laryngectomy is for
  • 42:56salvage which are not done at,
  • 42:59certainly not at in low volume places,
  • 43:01saving saving the larynx.
  • 43:05So I hope what I've done now is
  • 43:07you already knew that randomized
  • 43:09control trials are great.
  • 43:10They lead to practice changing innovations
  • 43:12in the care of cancer patients.
  • 43:14But I hope you can have a better.
  • 43:17Respect maybe for quality
  • 43:19of care research as well.
  • 43:21We can have a remarkable impact
  • 43:23on patient outcomes and I think
  • 43:25it's necessary for the quote real
  • 43:27science to mean anything to patients.
  • 43:29You have basic science researchers who
  • 43:31feed the clinical researchers within
  • 43:33clinical researchers feed the patient
  • 43:35centered outcomes researchers and that's
  • 43:38what leads to better patient care.
  • 43:40So Healthcare is remember this is
  • 43:42getting the right care to the right
  • 43:43patient at the right time every time.
  • 43:45That's quality cancer care.
  • 43:47Thank you.
  • 43:56Thank you so much for both for the
  • 43:58wonderful talk and the wonderful work.
  • 43:59Are there any questions either
  • 44:01here in the room or I know people
  • 44:05are also potentially posting?
  • 44:10Through the webinar.
  • 44:14Yeah, Tommy.
  • 44:18Open.
  • 44:21COVID-19.
  • 44:27I don't know yet is a short answer.
  • 44:30I think that's it's an area of active study.
  • 44:32There are some small scale
  • 44:34publications on that,
  • 44:35but I think we're going to know.
  • 44:37Pretty soon, I can tell you our experience,
  • 44:39but that's not based on the data.
  • 44:40Maybe Doctor Burtness has
  • 44:41more information about that,
  • 44:43but I think we're going to
  • 44:44know better soon enough.
  • 44:48I mean I I think we saw a number of,
  • 44:51I don't know that we have stats on it,
  • 44:53but we saw a number of patients with
  • 44:57considerable delays in diagnosis.
  • 44:59So I have a I have a question.
  • 45:02When we participate in,
  • 45:03so dragging you back to the
  • 45:05clinical trial side for a moment,
  • 45:07but a really important consideration for
  • 45:11surgically based trials is how do we set
  • 45:15what the benchmark is for the right surgery.
  • 45:19And I know you're participating in
  • 45:21the Sentinel lymph node trial now,
  • 45:24sort of how does that credentialing process?
  • 45:28Sit with our own quality enhancement efforts.
  • 45:34It's a good question.
  • 45:35I think you're right.
  • 45:36It's just exciting now to have
  • 45:38surgeons involved in randomized
  • 45:39control trials like ECOG 3311,
  • 45:41the Sentinel node trial.
  • 45:42It's actually great because it hasn't
  • 45:44happened a lot in head neck cancer.
  • 45:47You know, I think that for clinical
  • 45:49trials it's different than patient these,
  • 45:50these comparative effectiveness
  • 45:52researchers because you need to know if
  • 45:55the intervention is effective or not.
  • 45:57You need high quality surgeons every
  • 45:59time they need to be credentialed
  • 46:01and the surgical quality metrics
  • 46:03are being monitored constantly and
  • 46:04I think you need that for clinical
  • 46:06research and I'm glad it's there.
  • 46:08But how you apply that to the
  • 46:10real world I think is,
  • 46:12you know at the second
  • 46:13area of research interest.
  • 46:14But I'm glad they're credentialed
  • 46:16high quality surgeons during
  • 46:18the clinical trials.
  • 46:20We
  • 46:20have a a question from Doctor
  • 46:22Robinson in radiation oncology.
  • 46:24How do you disseminate the
  • 46:29these quality insights to?
  • 46:32The lower volume centers and are there
  • 46:35specific guidelines for which patients
  • 46:37should be referred for high volume?
  • 46:40Is it practical to refer everyone
  • 46:43with less common cancers like head,
  • 46:45neck cancer? And if not,
  • 46:48how do you feed these?
  • 46:52These care care approaches
  • 46:54to the lower volume centers.
  • 46:57That's a great question.
  • 46:58I think it's $1,000,000 question.
  • 47:00If we could do that honestly I
  • 47:02think we could improve survival more
  • 47:04than the next billion dollar drug
  • 47:06basically and I think that's that's our
  • 47:08challenge that's what we need to do.
  • 47:10I don't know I think every system
  • 47:12has it has a different approach.
  • 47:14I think Yale New Haven Health System
  • 47:15is going to be different than
  • 47:17memorial is going to be different
  • 47:18than pen is going to be different
  • 47:20than any health system but.
  • 47:21I don't know what the right answer is,
  • 47:23but we need to figure it out.
  • 47:28I guess I have a follow up question
  • 47:31to that and and that is some of
  • 47:34the hypothesis you had about what
  • 47:37controlled let's say the rate of
  • 47:40margin positivity had to do with.
  • 47:45Frozen margin evaluation communication.
  • 47:52Are are there components of that that
  • 47:55could be enabled by telemedicine?
  • 47:57So you know you referred to digital
  • 47:59pathology once or twice in your talk,
  • 48:01but are there ways that expert disease
  • 48:06focused let's say pathology evaluation?
  • 48:10Could be extended through telemedicine.
  • 48:14Yeah, I think that would be,
  • 48:16I think that's one way to bring expert
  • 48:20level care across the system with
  • 48:22telemedicine and I think pathology
  • 48:25would be a great way to start actually.