**Transcript of Cyberseminar**

**Evidence Based Synthesis Program (ESP)**

**Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review**

**Presenters: David Edelman, MD; David Aron, MD, MS**

**January 7, 2013**

**Shared Medical Appointments for Chronic Medical Conditions: A Systematic Review**

**January 7, 2013**

Heidi:  Perfect.  I’m just going to do a quick introduction and then I will turn things over to you.  Our primary presenter today is David Edelman, MD, associate professor in general internal medicine at the Duke University Medical Center.  He’s also an investigator at the Durham VA and a VA health services career development award winner.  He is joined by Dave Aron who is Associate Chief of Staff for Education at the Louis Stokes Cleveland Medical Center and is director of the VA National Quality Scholar fellowship program in Ohio.  He is also a professor of medicine and epidemiology and biostatistics at Case Western Reserve University.  And with that, Dr. Edelman, I am going to turn things over to you.

David Edelman:  Okay.  Let’s see—I think I know what to do here.  

Heidi:  Perfect.  That was just what you needed to do.

David Edelman:  All right.  Let me just do this so I can see my own screen.  Thanks to everyone who’s listening in today.  John Williams, who’s the last name on the screen you see, runs an evidence synthesis center for the VA down here in Durham and he invited me and a bunch of other folks that you see there to do an evidence synthesis surrounding the question of—several questions associated with shared medical appointments and I want to talk about those results today.

I’d prefer to talk about them while advancing the slides.  There we go.  Okay.  We need some common definitions here and let’s start by defining what shared medical appointments are.  They are a subset of the larger species of things that are called group visits where groups get together and meet—groups of patients, with one or a handful of providers surrounding some sort of core issue.  In the shared medical appointment setting the provider usually has prescribing power, so a pharmacist, mid-level or physician and the groups are usually organized around a chronic condition or some other healthcare state.  The SMA is designed to provide comprehensive care for that condition or health care state over time and it’s assumed that both self-management training and medication management are involved in these shared medical appointments.

Typical structure of a shared medical appointment is one to two hours in length at intervals of one to three months.  And these are rough guidelines.  Usually there is both a prescribing provider and a trained educator or facilitator.  Education is usually interactive in some way.  Most groups frown on a didactic approach.  Techniques such as motivational interviewing are involved and the goal is to activate the patient.

In parallel to this, the prescribing providers usually do medication changes.  These are done on an individual session.  They can be break outs or they can be done publicly if everyone agrees.  But the point is there’s usually education and medication change at the same time.

There’s been a fair bit of research into shared medical appointments.  It’s a fairly broad literature in terms of its—in terms of the number of approaches that have been taken scientifically.  There are studies in the frail elderly, but most studies surround SMAs relative to a single disease and most of the studies are in diabetes.  However, there’s not only a wide variety of scientific approaches to studying SMAs, the SMAs that are used are also very different.  Different settings, different patients.  Intervention approaches have some variability as you might imagine and studies have chosen to measure very different outcomes.

So with this in mind we set out to summarize the effects of shared medical appointments on a wide array of potential outcomes and here they’re just categorized crudely as patient, staff, and economic outcomes.  We also wanted to know whether these effects varied by clinical condition or specific intervention components.

I’m going to go over the meta-analytic methods in some detail.  And that’s mostly because we’re going to have some conclusions at the end of this as to what SMAs do and also conclusions about what we don’t know whether they do or not and I want you guys to know what sorts of studies ended up being evaluated by us for the systematic review.  It’s really important.  Topic development was sort of at the core of this.  We followed with systematic literature searches and chose studies by eligibility criteria and we’ll talk a good bit about that. Data are abstracted from the chosen studies and we also assessed the quality of those studies and finally we do the blood and guts work of synthesizing those data into some sort of scientific impression and generate a report.

We went after three key questions relative to shared medical appointments and key questions are ways of organizing your thoughts in an evidence synthesis.  So for adults with –  key question one, and you can see with the six lines in light blue that there’s lots of sub questions –  but do shared medical appointments, compared with usual care, improve the following: the things we looked at were patient and staff experience; treatment adherence, could be pill taking adherence, could be adherence to lifestyle recommendations; quality process measures: did you get things checked on time; biophysical markers: blood pressure, hemoglobin A1c, LDL;  symptom severity and functional status: if you were in an SMA did you feel better, were you able to do more things for yourself; and finally, utilization of medical resources or health care costs.  And so we went rather broadly to look for the literature surrounding the effect of—the efficacy or effectiveness of SMAs on any of these things.  In key question 2, we asked the simple question are there specific patients who benefit more from an SMA setting?  And in key question three we asked is there something about the intervention, is there a better SMA intervention that we can tell from the literature?

We developed a protocol—Dr. Aron and a number of other people in Central Office helped us develop this.  The literature search strategy is rather broad.  This was a little technical so I’ll go fairly quickly through.  Basically we took a wide array of medical databases so that we were trying to find more or less anything that had been published anywhere that we could think.  Search terms for group visits are actually very challenging because the nomenclature for what to call a bunch of patients sitting in the room with a provider or two has varied over the last twenty years and there are no sort of keywords associated with it.

We had to take a very broad approach regarding search terms as well.  And we had to consult someone who spends her life looking at search terms and tries to help us with that.  Finally, when we found articles we loved we looked through their bibliographies to see if there was anything there we’d missed, and to look for unpublished data.  On top of that we went to clinical trials.gov.

This is a slide that I will hit the pieces of as we go down the road, but it gives you a sense of how we started thinking about this.  I hope that the print is large enough for people to see on their screens.  So we started with adults with an array of chronic conditions and the reason that diabetes is in bold italic font is because ultimately that was where literally all of the disease-specific literature that met the quality standards we had set *a priori*came up.  We found no studies on the—of SMAs in the other conditions that met our definition of an SMA and our definition of a quality study.

Those are both fairly rigid definitions so if you think you know of a study that fits that it probably got tripped up over a technical issue along group visits.  We then broke down the SMA model looking at the size of the group, the number of patients in each group, the components, what you did, the team composition, who it was that did that, the presence or absence of somebody who could prescribe and how frequently they met.  We read each article looking for what they called usual care because usual care can mean a lot of things to a lot of different people.  We attempted as best we could to find any information about the patients, about their socioeconomic status, and about the healthcare system they were in.  We thought that might have an effect on the potency of group visits on these intermediate outcomes.  The outcomes there are adherence, satisfaction, and QI measures and also adverse events, which we looked for.  We hoped these studies would tell us if the groups were in some way harmful and then finally looked in the end for symptoms, functional status, biophysical measures, quality of life, and cost.

The primary exclusion criteria, other than failing the inclusions that we’ll get to on the next several slides, are that the publication wasn’t in English we just didn’t really have a way to manage it.  There is also a rich literature on group settings for substance abuse and a bunch of other mental illnesses and we decided to avoid that literature because it’s a very different theoretical model.  And just in case anybody was running inpatient groups, we decided to avoid those as well.  We included studies of high quality—of high study quality as determined by traditional metrics of that.   The Cochrane Group developed studies—sort of determines which study designs it thinks are strong enough to contribute to evidence that you might want to use something in a significant fashion so this limits us to randomized controlled trials, other trials with some sort of control, or observational studies with a contemporaneous—or a control group that’s not historical but that’s run at the same time.

Adults with one or more of these seven chronic conditions that we chose *a priori*, diabetes was the only one we found anything in, so it’s again highlighted here.  We also reviewed the extant literature on older adults without a single unifying disease because we knew that was out there.

We looked for studies that were set in an outpatient primary care or specialty care clinic or practice.   We looked for studies that fit our conception of an SMA model which was greater than two medical visits where greater than or equal to one healthcare professional, one of whom could prescribe, cared for a patient group.  So at an absolute minimum it’s a bunch of patients in a room with a doctor or pharmacist or an NP or a PA who is seeing them more than once.  The comparator was defined as usual care or some other quality improvement strategy, since often some sort of active, less potent intervention was provided to the control group.

We needed the study to report one of the following outcomes at at least three months out from baseline: patient or staff experience, patient satisfaction or staff experience; adherence to something, A1C, LDL or blood pressure; symptom severity; or utilization of resources.  Studies that reported none of these as outcomes were not included.

So we got a big chunk of studies from that and I’ll show you how big a chunk in a slide or two.  And we, this is all sort of the tip of the cap to the DistillerSR software.  We harvested the data from those studies into this software.  All studies were read by at least two reviewers.  Where there were disagreements about what the study said, we referred to a third reviewer or talked it through until we had consensus.

We wanted to know something more about the interventions.  To say SMA doesn’t convey anything particularly specific, so it’s hard to know what’s going on.  And we knew that there was an education piece.  We knew that there were patients that were coming back over time and so we tried to break this down to things that we thought might be important.  And we developed this thing called a robustness score.  The goal was to try to determine in some fashion what was a strong SMA.  And we then evaluated that strength, as you’ll see down the road, by asking the question, was this robustness score in any way associated with better outcomes?  So we asked was the person who led the group a certified diabetes educator or not?  Was the education based on some sort of underlying theoretical framework?  Did the group have closed membership, that is to say did the same providers see the same patients over time?  Or was it a drop-in group where different patients were allowed to come and providers rotated through depending upon their availability at the moment?  And did the intervention process include individual sessions where patients could discuss their medication changes?  Were there medication changes made?  And just a summary of above or below median split on the number and length of visits in the intervention.

Two of these were worth two points, the others were worth one and that led us to a robustness score range between zero and nine.  We assessed the quality of each article as good, fair, or poor.  And there’s a lot of stuff here but the most important thing to take from this slide is that there is a standardized way of determining whether the evidence from an article can be interpreted—whether the article should be thought of as good/fair/ or poor when you’re interpreting the evidence from it.  We used that standardized method and the slide’s here for people who want to read it.

And then we put the data into the software, made a bunch of tables.  Where we had enough data we did traditional meta-analysis.  And again, there’s a lot of technical language on this slide, but basically we used standardized methods for meta-analysis and standardized software.  I will tell you as we go through the outcomes where we used meta-analytic techniques and where we’re just sort of summarizing.

Finally, we attempted to look for publication bias.  We did formal assessment of whether we thought negative studies were not being reported.  And again, at the end we asked what is the strength of the evidence that we found?  If we found that SMAs improved hemoglobin A1C, how confident are we that the evidence supports that?  And by looking at the strength of the articles, the risk of the bias in our assessments, the consistency—how do we see the same thing over and over again in each article we reviewed, and the precision of the estimates.  Was there a statistically significant meta-analytic result, for example, we determined whether the answer we’ve come to for each question is a strong answer, a moderately strong answer, a weak answer, or whether there’s insufficient evidence to answer it at all.  Again, this is standardized methodology.

What did we find?  We found 1,104 titles that seemed promising and screened out 1,009 of them just by looking at titles and abstracts.  95 references were read.  You can see why we removed 71 of them fairly quickly.  Most of them were either not primary data articles or they were of weak study design.  Twenty four articles ultimately made the cut.  Those are the ones we’re talking about when we go through the results.

These are the patients in the studies and now we’re down to nineteen studies because some of the twenty four articles are reporting on the same study.  So we’re working on a sample size of about 3,200 patients with diabetes and about 1,800 older adults.  And most of the studies in both sets are randomized controlled trials.  The trials are about equally distributed to good and fair design for diabetes and were not particularly strong for the older adults.  Most were done in single sites.  And most of them were done at twelve months or greater.

I don’t know how many people who are listening to this have ever seen one of these ugly plots to look at the effect of the meta-analysis.  We did formal meta-analysis on the outcome of hemoglobin A1c and the short version is that the effect on hemoglobin A1c of diabetes SMAs was to improve it by .55 percentage points.  The long version is if you look at the diamonds—if you look at that diamond, right there, that’s the summary estimate for the good studies, the trials considered to be of good quality.  This one here for the trials considered to be of lesser quality.  Long story, short, what you have is an estimate which is relatively potent.  Half of a percentage point of A1C and if anything seems to be a little bit strong, that’s not a statically significant inference, if you look only at the studies that had used stronger scientific methodology.

That’s kind of a promising effect.  What about the other biophysiological things?  Only five studies looked at blood pressure.  Only five studies reported blood pressure, but those five studies were fairly consistent in reporting a positive effect on blood pressure and so what you’ve got here is systolic blood pressure dropping by 5 mm.  And again that’s fairly tightly statistically significant.  You can see the little diamond down here where that’s the mean effect and these are the 95% confidence intervals.  So we’re pretty—we have a fairly high degree of confidence.  We’ll talk about it more formally later that diabetes SMAs also improve blood pressure.

This is LDL cholesterol, and the two things you should take home from this study—I’m sorry, from this summary first of all the effect is somewhat more modest—6.6 mg% is a smaller clinical effect, I think, and we’ll discuss that later than 5 mm of blood pressure for example and it doesn’t quite reach statistical significance in the meta-analytic framework.  So we are less certain that shared medical appointments for diabetes do anything good for LDL cholesterol.

That’s only a tiny piece of the outcome framework that we were looking at, right?  That’s the biophysical stuff, and that’s what everyone measured and it’s important.  We wanted to know a bunch of other stuff and the long story short version of this slide is we didn’t find it.  We did not find a convincing effect on patient experience because only two studies measured it.  Two studies looked at patient satisfaction among diabetes SMAs.  They used two different measures.  They came to two different conclusions and we have no data using these twenty four studies on this.  None of the randomized trials, none of the contemporaneously controlled observational studies measured staff experience.

Only three studies measured treatment adherence.  Only two of them measured adherence to the same—to the same kind of treatment, two measured pill adherence.  Again, they used two different scales.  Again, we don’t have any conclusions.

Interestingly enough, Health-Related Quality of Life was measured in two different ways but—in two different categories of ways but in the same with the same measure by each of the two different categories.  The two studies that used a global health status measure found no effect so it didn’t have this great spectacular impact over the short term on people’s general health and well-being.  Those that used the diabetes-specific measure did find an improvement.  This is a measurement effect probably.  People—diabetes-specific measures are more sensitive to change and it’s more—you can interpret this how you like, but there seems to be some modest change improvement in Health-Related Quality of Life.

Lots of studies focused on utilization relative to these other outcomes.  We were unable to meta-analyze these for technical reasons, but five studies did look at hospital admission rates and four of them reported reduced admission to the hospital.  So four of the five diabetes SMA studies that looked at hospitalizations improved them.  The same five studies all looked at ER rates and had variable results.

Costs were all over the map in the four studies that measured them.

We did find three studies in older adults.  The studies were of lower quality.  All the studies showed improvement in satisfaction using different non-validated measures so it’s hard to know what to do with that.  Both of the trials showed lower emergency use and admissions and both of the trials showed a statistically significant improvement in ER visits.  So if SMAs for older adults do anything, and three studies, two fair quality trials is a little bit of a stretch to make a strong conclusion about anything—they seem to lower emergency room use.

There we go.  No study reported specific patient characteristics that led to better response to SMAs.  So nobody asked the question which patient group did better?  We didn’t have much to go on.  We did not have individual patient data for these studies that we evaluated, just the estimates that you read in the manuscript.  So we went ahead and evaluated very crudely whether patients with worse baseline A1c did better in SMA interventions and from study to study they did not, but we can’t tell from patient to patient.

Our robustness index that I spent two minutes describing earlier in the talk was a total flop.  No study reported specific intervention components that were associated with the effects of SMAs.  We tried to cook some sort of estimate and that didn’t go well. Our, basically we still couldn’t figure out what sorts of aspects of an SMA led to better improvements in outcomes.  

And then we didn’t find anything on cost effectiveness, staff satisfaction, access, and anything about key elements to successful implementation.  One of the things our partners in Washington wanted to know is what is the literature on how to successfully implement SMAs and that piece of the evidence synthesis at least from our perspective looking at sort of randomized controlled trials mostly didn’t get started because nobody had addressed it in that sort of fashion.  So, a really important question remains unanswerable by traditional evidence synthesis methods.

So what do we take away from all of this?  Actually, as best we can tell, in these scientifically tight settings, SMAs are pretty potent.  You know, half a percent—if you put—you have a patient with diabetes and you have a treatment and the treatment is not for everyone but some people really like it and you can lower their hemoglobin A1c by half a percentage point, their blood pressure by 5 mm, and their LDL by 7 points.  I mean, that’s all in one patient, that’s a pretty good chunk of cardiovascular risk reduction and microvascular risk reduction.

A patient that was able to realize the mean benefit of SMAs in our study would do really well—so I think the diabetes group visits are—come out of this meta-analysis looking pretty good.  They would still be a pretty potent event, a pretty potent intervention if fully half the efficacy were lost in translation.

Can you take that to the bank?  These are randomized controlled trials.  So there’s a standardized framework for asking is this likely to work if I implement it?  And there are some hits and some misses on that.  The populations in these studies were widely demographically balanced, and I don’t think it’s—I think it is reasonable that these findings would generalize to most populations.  Interventions:  the components are very heterogeneous.  We don’t really know what kind of SMA interventions—what kind of education—frequency of setting, size of groups.  We don’t know if any of that is important.  It is possible that you could set up in your own facility a group intervention that would be different enough from the average of these studies that it wouldn’t do well or it would do better.  We don’t know much about the comparators.  Most of these studies were compared to a poorly described “usual care”.  The outcomes I mean, again—fairly large movement of fairly important outcomes.  I don’t think that’s a problem.  We set six months as the primary sort of the primary outcome for the meta-analysis and I think there’s general agreement that six month’s improvement is important. None of these studies looked at what happened when you stopped the groups, if you stop the groups.  Some of them carried the groups out to as much as four years and showed continued improvement, but none of them just straight up stopped the groups and saw people—went back to baseline.

Finally, all of these settings are very academic.  This is a VA webinar and probably five of the thirteen trials in diabetes are VA settings and this probably generalizes pretty well to the VA.  But I don’t know that I would take these data out to the non-VA setting and say, do this and you’re going to realize these benefits.  I do think that a setting with very engaged, thoughtful primary—with relatively engaged thoughtful, primary care design does not—such as the ones these studies were in may resemble VAs, but does not resemble every primary care setting in the real world.

So what else do we want to know about SMAs?  Now I’m stepping out of the meta-analytic framework and asking what’s the next questions that people might want to know about?  I think we probably ought to look at other chronic illnesses.  It’s unclear to me why there are thirteen randomized trials in diabetes and none yet published that meet our definitions of high-quality trial of SMA in these other studies.  It probably would be a good thing to look at other illnesses that are less complex to see if the benefits still extend.

It’s probably time to start breaking down the black box of SMAs, and using different study designs that allow better evaluation of what works and what doesn’t—of all the moving parts in an SMA intervention.

Implementation studies are needed and are ongoing, but good measurement of patient and staff impacts using not just traditional number-grinding studies but also careful what’s called qualitative methodology—careful, surveying focus groups, finding out from people on the ground what you’re doing and also measuring unintended consequences on the system.  When you redesign a system to make diabetes SMA, it is possible that something will get left out and that’s never been studied.  Finally, strong cost and cost-effectiveness analyses are needed.

Thanks.  I appreciate it.  I’m going to now figure out the technical details of turning this over to Dr. Aron.  I think it starts with this.

Heidi:  Actually, I just took care of it, so Dr. Aron you should have that button that just came up on your screen.  If you just click on that to show your screen, we should be able to see your slides.  There we go.

David Aron:  It’s important that everyone listening knows that Dave and I are quite good friends.  So anything I say is not personal unless I say it’s personal.  What you heard was a very fine researcher speak and that is one particular way of approaching this issue, okay, and I’m going to talk about a somewhat different view of things, and you’ll see what I mean shortly.  So you can see the title—Dr. Kirsh and I were the primary people doing this review with the—all the others who are mentioned from actually from one coast to another and John Ovretveit is from the Karolinska in Stockholm.  This is a work in progress, another issue I will get to in a bit.

I have basically a couple of objectives.  The first is to discuss what we did and why we thought it was needed, to describe our experience and then open it up for both Dave and me for questions.

Susan apologizes, but is unable to be here because of a health issue although she may be listening in and available for questions at the end.  Before David’s systematic review, this slide shows the most recent systematic review.  I guess the bottom line is how little you end up looking at at the end.  And the results of this review by Burke, et al showed basically the same thing that David and his group showed, with the implications which I think David also mentioned, although not exclusively, is that RCTs are needed.  And as a former chief of medical service, let me tell you this does not cut it.  This kind of information is not helpful to me as a manager.  What a manager wants to know what works when and for whom?  Is it going to work in my context?  And in addition as a manager I don’t live in a p<.05 world.  If as Chief of Medicine all I did was things that I was 95% sure they would work, that’s all I did, I wouldn’t be doing much.  Now one could argue that that might be the right way to do it.  I’ll be happy to have that discussion.

I think it’s really important at this point to bring this back to the IRB of all places.  This is the infamous 45 CFR 46.102(d) which defines what research is from a standpoint of human subjects.  Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  Now the question is what is generalizable mean and how do you know something is generalizable without actually testing it?  Or to put it in another way, is—and I should say that almost every health services research paper that I’ve ever read has included the statement at the end that says something like this population was limited and the results may not be generalizable.

This is a really important question what it means and I’ve been unable to get an operational definition.  Now this is where philosophy comes in.  And in fact when I asked a question on an HSR&D call  the answer that I got, when I asked what’s the definition of genralizablity, the answer that I got was that that is a philosophical question.  So I thought I would consult a philosopher of science, Nancy Cartwright at both UCSD and the London School of Economics.  And she wrote—and I’m going to quote this and the reference is down there at the bottom,  “Scientists, including social scientists, are often dismissive of philosophy.  Philosophy, it is said, is too abstract, too fussy, and too taken up with its own problems to matter to real practice.”  And I should just insert my own view there that one could say pretty much the same thing about a lot of health services research, but I digress.  “With the issues discussed here (*efficacy, evidence, RCTs and policy)* I think just the opposite is the case.  Bad practice, I maintain is being recommended without intention and without sufficient notice in part because prissy issues that philosophy fusses about are being ignored, issues like what counts as a proper definition and whether an argument has been laid out with all the necessary premises.”  I think we’re going to have to come to grips with this issue of generalizability.

Since we have—since I’ve quoted a philosopher, it’s important that we understand what our philosophical bases are for our research.  And we all have them.  We all have our mental models and they’re all incomplete.  That is the nature of models as simplifications of reality.  And here are three basic schools. David’s work and much of what is published in health services research is in the pure positivist well, which says there is an objective reality which exists independent of us.  While realism is there is a reality with which we interact.  And constructive—social constructionism is that the reality is subjective, we create the reality.  Now that—there are different epistemologies, different ways of looking at causation, and different implications for evaluation.  Now the easiest way to distinguish these is to consider a baseball umpire who has just called somebody safe, as that picture shows.  Now there are three kinds of umpires.  There’s the positivist umpire, there’s the realist umpire and the constructivist umpire.

The positivist umpire says that I call them as they are.  The realist umpire says, I call them as I see them.  And the social constructivist umpire says they ain’t nothing until I call them.  And they’re really very different.  It’s a simple distinction, but very different approaches.

Now if you think about RCTs, RCTs are designed to have very high internal validity.  And it’s designed to kind of isolate the confounding factors as best as possible so that they don’t play a role in determining causation and you have very comparable if not identical control groups.  That doesn’t occur in—that doesn’t describe the real world.  It certainly describes a way to get an internal valid answer.  But whether internal validity precedes external validity and generalizability is a totally different question.  In a theory driven, context-dependent approach where external validity is critical, the external changes that are part of interventions must be reported together with the results, that is to say a context.

And that there’s not a simple linear causality.  But we need to look at a broader concept of what constitutes causality.  And finally, theory driven, context-dependent approaches say you can’t isolate the confounding factors.  You can’t randomize them out because, at least when we’re talking about organizational interventions or any socially complex intervention, you could never get a sample size large enough to really isolate those.

So a realist evaluation is another approach or a realist synthesis.  And we’re relatively early in the development of this method or series of methods.  And the whole idea is not to answer does it work or not in some particular circumstance, but rather what works for whom and in what circumstances?  So this is kind of a manager-friendly approach.  Now there are methods—okay, that include identifying the review questions, searching for primary studies, doing good quality appraisal, extracting the data and synthesis, but it’s really much more complex than that.  It recognizes that we start from an initial conceptual model and have some questions we’re trying to answer—we end up revising the model, describing the evidence, and doing these all in a very, very iterative fashion.  I’m going to give you some concrete examples of that.

This is not a purely linear kind of way of doing things.  And it makes it extremely difficult to report it and in fact there are no standards yet although there is a committee called RAMSES which is meeting that was supposed to have published its standards for reporting similar to the CONSORT standards and that kind of stuff last October, but I have yet to see anything come out yet.

So there’s another problem here.  There’s more than one way to conduct a realist synthesis.  It is more of a general approach than a very specific linear number of steps.  And since I’m an endocrinologist I like just to include this little slide of Fuller Albright, who is one of the greats in the history of endocrinology, who basically said there’s more than one way to skin a cat.  Now at the Massachusetts General Hospital, they prefer A, but that isn’t to say that B doesn’t work.  So what is a realist review or synthesis or evaluation do?  And there are specific definitions for what constitutes an evaluation versus a synthesis versus a review, and I try to be a lumper in this particular realm and not a splitter.

Basically what we try to do is identify the mechanisms, the context in which they are activated, and the outcomes to which they lead.  A so-called CMO configuration.  And these clusters we call that fit together we call demi-regularities.  Okay these are not P<.05.  These are things that look like they make sense based on things that seem to tend to happen.  They’re not laws.  And we bring to bear mid-range theories to help understand these patterns.

Ultimately we can build or test a theoretical model of how a program might actually work.  So “mechanism” here is defined as the “underlying entities, processes, or structures which operate in particular contexts to generate outcomes of interest.”  It is an attempt to begin to unpack the black box.  Mechanisms are usually hidden.  They are very sensitive to variations in context and for social interventions, the mechanism typically refers to some cognitive process or what turns on in the mind of the participants.  So how do you do that?  You identify the basic logic.  You configure the contextual features and mechanisms that determine the outcomes.  And we refine the theories.  So for realist synthesis of a single case, the underlying logic is understood as the program theory and every program has a theory.  And middle-range theories are somewhere between extremely specific and extremely general.  And they—the kind of things we typically include in HSR&D grants are middle-range theories.  But you know every—as one of my teachers in medical school taught me you never use a five dollar word with a ten dollar word, so don’t use two partners or a pair when you can call them a dyad.

Here’s the initial conceptual model, and this was based on prior work on SMAs.  And we’ve actually been running SMAs here for close to seven years.  We’ve had over 1,200 patients go through them. David’s randomized controlled trial was informed by that particular project.  And here is what we think.  There are certain factors that influence a patient with diabetes.  And shared medical appointment and we thought peer support and multi-disciplinary expertise influenced that patient to become a more informed activated patient and medication adjustments added to that by the clinicians resulted in some outcomes.

John Ovretveit, who’s a management researcher, contributed a number of management-related questions.  And we did our systematic review of the literature in a pretty similar fashion although our criteria for inclusion of articles was much, much greater and we did not give a particular preference to RCT’s.  Quasi-experimental studies were fine.  Pretest/post test were fine as far as being eligible for inclusion.  We found a bunch with non-chronic conditions and we eliminated those and ended up with forty three chronic illness studies with reasonable data as you can see in this slide.  In general, the characteristics of SMAs were pretty heterogeneous.  There was an educational component was explicitly stated in 89%.  There were multi-disciplinary members in about two thirds, a behavioral intervention in about half.  Medication adjustment was not always included.  Peer-to-peer support was very common and occasionally, just under half, there was actual clinician training to do group visits as opposed to just throwing people in.

Visit duration varied tremendously, although a majority were in the 90-120 minute range, and the visit frequency was also quite variable and you can see how much missing data there are.

Here was our initial model with the management questions.  And I think I may have included the slide of the management questions at the end, but suffice it to say that these were questions that were designed to help managers decide whether to implement SMAs or not.  And we started in this iterative process—we unpacked mechanisms and this was our next conceptual model.  There were a bunch in between but I’m giving you kind of the highlights.  There was an external context, a patient context, what happened in the SMA itself, the dose and a wide variety of outcomes.

Here are kind of the demi-regularities that we were looking for.  So the first question is does it matter whether you’re urban, suburban or rural as to whether it’s likely that something will work?  And our mechanism was that we—travel distance would affect participation rate.  In fact the effects were very similar, it didn’t matter.

Patient factors like socioeconomic status.  We know socioeconomic status is associated with educational attainment but we found when we compared multiple studies that the effects were similar and across chronic illnesses the effects were also similar.  We did get some differences in what was happening within the SMAs, so behavioral components tended to have better outcomes.  Multi-professional tend to have better outcomes.  Medication adjustments had better outcomes and duration of 90-120 minutes was intended to have better outcomes than less than ninety minutes.  Explicit peer support also was associated with better outcomes.  And so here is an unpacking of that series of mechanisms to a more broader middle-range theory that beliefs and attitudes towards self-management are then impacted by motivations to comply with others, trust in peers, evaluation of outcomes, learning in context, leading to change in beliefs about or more positive beliefs about attitudes towards self-management and more effective self-management.  So this takes into account self-efficacy theory, health behavior change and so on, the established theories.  And this is how we created a logical theory-based chain to explain why multi-professional might work as well.

Now how is it different—much, much more iteration. It’s also principles, not a series of sequential steps.  There’s also no particular preference for quantitative or qualitative methods.  The stakeholders in doing the review are themselves multidisciplinary and often are people with experience in SMAs and that’s what our group contained people with expertise in management, in management research, in SMAs and we had nurses and doctors and Ph.D.s.  

So the lessons that we learned:  first, generalizablity is not just a philosophical question, it is a core to practice in the real world.  And it’s not necessarily that we need further “research”, i.e.., more RCT’s, but when researchers report, we need reports on different information.  We need to know much more about the context.  Now this is not a method to manufacture new data.  We can only look at the existing data in a different way and draw inferences that may not be as strong as those from an RCT, but are useful for management.  One other thing we also note is there’s very little information on the patient perspective in this.

So here is an overall summary of the differences that you can look at at your leisure and I will open it up for questions, comments, rebuke, and so on.

Heidi:  Great.  Thanks Dr. Aron.  For our audience, this is a great opportunity to submit some questions.  Please use the Q&A screen in GoTo webinar to submit those questions to us.  The Q&A screen is located on the dashboard on the right hand side of your screen.  If it did collapse against the side of your monitor just click on that orange arrow at the upper right hand corner of your screen to open that pane back up.  We do have one pending question.

David Aron:  And I am pleased to report that we lost only—we lost less than 10% of the audience during the presentation.

Heidi:  Fantastic.  Hopefully they’ll stick with us through the Q&A portion right now.  So—the question that we have pending right now—I may have missed in intro, but did your definition of SMA require opportunity to adjust medications—the fact that you included it in robustness score implies not.  Did you examine that as a single feature that influences effectiveness?  I recall some earlier work suggesting it was a critical element.  

David Edelman:  Can I have—how do I gain control of the slide—there’s a—the answer is we did require it.  Hold on just a second.  There’s a small technical issue here that I did not explain very well.  I’m trying to get the slide up with the robustness score.  The key word here and the word I should have emphasized on this slide is “within.”  All of our intervention—all studies—all studies admitted to the meta-analysis did require that medication changes be made.  A handful of studies chose to make them not in real time.  So medication changes within visit means the patient had a medication change plan to leave the group session with and the alternative, the less strong option was a call back with a medication change plan.  And I’m sorry that I got hung up on a technical issue there and I hope that answers the question.

Heidi:  Great.  Thank you.

David Aron:  One of the other means that that was accomplished in the papers by Trento, which are basically two studies and four papers.  The medication change occurred with after the group visit, immediately after when the patient met with his or her physician.  And since you included those Dave, I assume you included those as within reason.

David Edelman:  Absolutely.  Yes.

Heidi:  Great.  Thank you.  The next question here, please give the exact prototype model used for SMAs.

David Aron:  Well, the prototype that we use is based on our work in Cleveland. There’s actually a manual that’s on the QUERI website.  It’s in the Diabetes QUERI section.

David Edelman:  And so I’m not only the author of the meta-analysis but we did one of the randomized trials that we meta-analyzed and in our study our prototype was actually based directly on what Dave and Susan did in Cleveland.  We used the same prototype with only minimal adjustments when we moved to the trial setting.

David Aron:  I should say that there is one difference and that is and Dave correct me if I’m wrong here—

David Edelman:  Mh huh.

David Aron:  Is that  number of types of clinicians that you had was relatively small.

David Edelman:  Um.  We had if your definition—depending upon your definition of clinician, it’s yes.  It’s two.  We used exclusively MDs and pharmacists for the prescribing end and we used exclusively nurses and dieticians on the facilitating end.

David Aron:  Okay, basically pretty similar.

David Edelman:  Okay.

David Aron:  The one difference is that we have a health psychologist who actually moderated many of the groups at the beginning.  And that just goes to one of the big problems in that any manger faces that everyone does things a little bit differently.

David Edelman:  And you know—yes.  And we were pretty forthright in the meta-analysis that we had limited ability with this methodology to understand that diversity, that people do things a little bit differently. In our trials—in our two-site trial for example, we allowed the two sites to do things somewhat differently.  That difference may be strength of that study, but if you’re trying to understand the broader context of the literature, it may be helpful or may be confusing.

Heidi:  Okay.  Great.  Thank you.  The next two questions that we received are both about the realist framework.  One is for Dr. Aron and the other is for Dr. Edelman, but I’m going to ask them at the same time and hopefully you two can play off each other a little bit in the response here.  The first one for Dr. Aron, I want to know how in the realist framework you decide which studies are worth including and which are not?  And for Dr. Edelman, how do you view the pros and cons of the realist systematic review on the same topic?

David Aron:  Okay, so we included a study if it actually included data.  We eliminated—there were a lot of opinion pieces and commentaries and advocacy pieces that we eliminated.  But if it had either qualitative or quantitative data we ended up including it at least at the outset.  So we, very broad is what I’m saying.

David Edelman:  How do I—nobody has ever asked me to directly comment on what I think of my friend’s work in this field?  Wow this is an opportunity.

David Aron:  Are you kidding me?  We had a—we did a session together.

David Edelman:  Yeah.  But I carefully avoided—we talked a lot about what I thought were the strengths of my stuff and what you thought were the weaknesses of mine, but we didn’t talk so much about yours.  

David Aron:  Okay.  Fair enough.  Knock yourself out.  I can take it.

David Edelman:  I think that, I think that it’s hard—okay.  As best as I can tell, and I have not in all fairness read in detail the most recent product of what Dave is doing.  As best as I can tell, they’re answering different questions.  I mean, we’re attempting to answer—what a meta-analysis does really is says under pristine conditions or something close to pristine conditions what can you expect to happen to patients in this setting?  And what a realist review seems to be answering is not so much what can you expect to happen but in the muddy realm of the real world but what kinds of things might be good things to try in your own setting?  If I’m reading that right, then they’re enormously complementary.  You know you could think of—go ahead, sorry.

David Aron:  I was just going to say that I completely agree.

David Edelman:  Okay.

David Aron:  Except—And I’ll let you finish before I give my exception.

David Edelman:  Okay.  If I’m correct about that, then a manager can sit down, read the two papers, and set from mind some reasonable targets and some very crude baseline approaches and then dive deeply not just into Dave’s writing but his or her own knowledge of her/his own clinic setting and make some very, make some more educated but still uncertain judgments about how best to go after the target set out in my stuff.

David Aron:  I think that’s a very fair way of looking at it.  Where I would disagree somewhat is with the assumption that there are or that there is such a thing as pristine conditions.  So let’s take your RCT, for example.

David Edelman:  Oh.  Okay.

David Aron:  Okay.  It was effective. 

David Edelman:  Yes.

David Aron:  I don’t think there was much of a site difference if I remember correctly.

David Edelman:  There was no site difference.

David Aron:  Right.  But it involved a very specific set of individuals.  Now whether it would have done better or worse in the same setting with different individuals, and I’m talking about the staff, let alone the patients is, you know, an empirical question.  I think that—so I—and I suspect and this is where my concern with stopping at answering the question does X or Y work on the average is that is what really is the mechanism.  Can we really isolate a mechanism?  And I’m not sure for a socially complex intervention like this, which is to say people interacting with each other, whether you can really isolate a mechanism, which is to say prove causality, and again it’s causality on the average.  And I realize these are kind of philosophical discussions.

David Edelman:  Yes.

David Aron:  But we all approach our work with mental models that have, that are based on, you know, certain philosophical tenets.  I mean, we have a particular epistemology for our work and so on, and I think one of the things that a web seminar like this one helps do is make explicit what our mental models are.  And I agree, these are complementary and should not be competitive.  Nor should one be necessarily favored.

David Edelman:  No.  You are correct. I wake up in the morning, get out of bed, get in the shower, and say I’m going to discover the truth today.  And that’s—and I’m not—I’m no longer as naïve as I was about how broadly applicable those truths are as I was when I first started doing this.  It’s still that mindset.

David Aron:  Yes.

David Edelman:  And the traditional meta-analysis is driving towards what it perceives as an underlying truth.  I still think that even if you believe that that truth doesn’t exist or is so diffuse as to be worthless, that you—that the meta-analysis has a lot of interesting things to say.  It’s still—I mean the in large part because of what you said.  It’s the summary of these sixteen non-pristine experiences.  And I understand that sixteen non-pristine experiences don’t, aren’t the same as seventy or eighty or ninety, but by taking these ones that in some ways resemble each other, if in no other way than in the purposes of the study, you do get some sort of baseline to start working from.  It’s why we favor meta-analysis over single trials.

David Aron:  I’m totally fine with that.

David Edelman:  Yes.

David Aron:  These should not be considered competitive nor is one necessarily superior to the other.  I would argue just as strenuously that the realist approach has certain advantages over the orthodox positivist approach for some circumstances, but not others.

David Edelman:  Hm.  Heidi are there more questions in the queue?

Heidi:  We do have more questions in the queue.  We have about nine pending questions right now.  I didn’t know how long you two are able to stay on for questions?

David Edelman:  I can go at least until 12:30.

Heidi:  Okay.

David Aron:  Fine with me.

Heidi:  Okay.  The next question we have here, in a realist review, how do you sort out variation that is a result of context or mechanism from that due to random variation?  Isn’t there a risk that one will come up with post hoc theories to explain what is just random variation, especially if one is beginning with a preconception about how effective something is?

David Aron:  So there are two answers to that question.  The first is we’re all beginning with preconceptions, regardless of what your study design is, so let’s put that one aside.  Second, you—I think you are absolutely right. So when I infer something I call it a demi-regularity, I don’t call it a statistically significant conclusion.  So it is a tendency.  This is a place where one might start.  Even if something works really well in Cleveland and someone in another place takes the exact same model and plops it somewhere else, I think it has a better chance than if it were done in a completely different model, but it’s—there’s no guarantee.  Yes, there is a risk.  And one needs to be cognizant of that risk and frame the conclusions with that kind of uncertainty.  I like the way that David put it.  It’s a more educated answer, but it’s not “the” answer.

Heidi:  Okay.  Thank you.  The next question we have here:  While availability of medication intervention is a requirement of the definition of an SMA, it appears that an actual change in medication is a requirement of an effective change.  Is it not possible that no change in medication, for example, no increase needed, is also a positive effect?

David Aron:  What we looked at was the presence of a medication changer.  Not whether medication was actually changed.

David Edelman:  And all we—

David Aron:  Frequently medication is not changed and there are behavioral changes.  Or dietary changes.  At least in the diabetes ones that we had done.

David Edelman:  Same here.  Only difference is that we attempted to sort it out into having the opportunity to change or not change medications in real time versus having the opportunity to change or not change medications in a call-back format.  That’s all.

Heidi:  Great.

David Aron:  And just maybe this is anecdotal, but the plural of anecdotes actually is data.  It may be lousy data, but it’s still data.  One thing—

David Edelman:  [Laughter]

David Aron:  That I’ve experienced as an endocrinologist to whom we get referred patients who don’t want to go on insulin, okay.  And sometimes we are able to convince them, sometimes we’re not.  The, I cannot recall the last patient that we had in an SMA who in, in whom it was recommended that they start insulin that they actually didn’t.  That and it seems—and it’s just a general impression that the kind of peer support is really critical to that.  And I’ll just tell you a story because stories are very powerful.  We were doing a mock SMA in front of our first-year medical students to give them an idea—a new model of care, show how endocrinologists can defer to nurse practitioners and still feel okay when they get up in the morning and at the end of this mock SMA, and we had said—I got a bus and brought over a bunch of veterans and the whole team.  We had a little panel discussion at the end and one of the students asked what is the most difficult challenge you faced after becoming diabetic and this guy who was in his sixties, kind of grizzled, strokes his chin and says, I was in Nam.  I’ve been shot.  I’ve been beaten.  I’ve been stabbed, but the idea of injecting myself every day scared the living crap out of me.  And all the other veterans at the table started nodding yes, yes, yes.  And it was an extremely powerful lesson to me about that idea of peers.  You don’t get that in a orthodox systematic review or even in a realist evaluation for that matter.

Heidi:  Wonderful.  Thank you.  The next question we have here, the attendee wants to thank Dr. Kirsh for providing information for them to start our DM SMA at Montrose.  They have been collecting data on labs, weight, A1c, LDL, and patient satisfaction through a survey handed to the vets right after the SMA.  What resources do we have to have this data analyzed?

David Aron:  If you contact me I would be pleased to take a look at it and at least offer some suggestions.  That’s david.aron@va.gov with one A in Aron.  Dave might feel the same way, but I won’t speak for him.

David Edelman:  I do feel the same way.  I’ll, just send me an e-mail.  I’m david.edelman@va.gov.  And we can talk about it.  The—that—the greater question there is something that’s just—I have a long answer to that question, but whoever put the question in send me an e-mail and I’ll give you the long answer.

Heidi:  Great.  Thank you.  The next question is for Dr. Edelman.  Has anyone compared SMAs to the Stanford Chronic Disease Self-management groups?

David Edelman:  No.  I shouldn’t say no because Dave Aron’s reviewed the less tidy literature more than I have.  I can say with great comfort that no one has published—no one had published by mid to late 2012 a randomized controlled trial of such a thing. It’s a very—the Stanford self-management group model is basically a—I don’t want to speak. I’m speaking a little extemporaneously and might miss some things, but a crude description of it is a very intense self-management group setting usually without medication management and it’s been incredibly potent in a number of studies in symptomatic illnesses, less so on biophysical outcomes in asymptomatic illnesses in what randomized trials have been done.  But no one’s ever done a head to head and it would be interesting to do.

David Aron:  I’ve never seen a head to head comparison.

David Edelman:  Yes.

Heidi:  Okay.  Great.  Thank you.  The next question here is what is the bottom line?  If you were to create the best possible self-management intervention for a particular disease or group of patients now can you summarize what that would look like?

David Aron:  I think it would—I think Cleveland got it right at the start.  Multi-professional, with professions being added as they were needed.  So for example, dietetics—dieticians were not included when the SMAs began, but the patients clearly wanted that so they were added.

Adaptability is another key aspect.  The second is emphasizing peer to peer support.  And the third is the ability to make medication changes.  Interestingly, we haven’t published this yet, but we looked at the outcomes of patients with and without concomitant mental health conditions and there really were no differences.  There were just as—SMAs were just as effective which was striking to us and surprising.  But I would strongly recommend going to the manual.  And it means modifying to your own specific circumstance.

David Edelman:  See, that’s what I thought you were going to say at the beginning, Dave.  We have seen two presentations.  My presentation says I have no clue how to do it right.  Your presentation would seem to suggest that while there may be some sort of general leanings, the most important thing may be to contextualize it yourself.  So I thought you were going to start—I thought your answer to that was going to be whatever you think you can do best at your facility.   I have an easy answer, I don’t know.

David Aron:  Yes. I mean, I think that’s probably true, but maximizing those things that seem, and I emphasize the word seem, to work.  Peer support, medication changes.

David Edelman:  Perhaps just a little touch of positivism in there after all.

David Aron:  You know, I’m not pure anything although some people call me pure, you know what.

Heidi:  I try to keep myself muted so I don’t laugh out loud when you guys say stuff like that.  I have—

David Aron:  Muted.  That’s part of the context.

Heidi:  [Laughing].  Okay.  We have 12:29 on my clock right now.  Is it okay if we wrap things up or did you want to take one more quick question before we—

David Edelman:  Do you have one more quick question?

Heidi:  I think I’ve got one more quick question.  Are you aware of anyone using SMAs to discuss advanced directives?

David Edelman:  No.

David Aron:  I’m aware—

David Edelman:  But really, really cool idea.

David Aron:  That’s—I’m aware of a group that is interested in studying that but that is all I would be privy to say.

Heidi:  Okay.  That’s fair.  We’re just about at 12:30 so we’re going to wrap things up.  Dr. Edelman, Dr. Aron, do either of you have any final remarks you want to say?

David Edelman:  Thanks for listening.

David Aron:  And if you have any comments on how either of us could make this better, tell us.

David Edelman:  Always.

Heidi:  For our audience, we do have feedback form that should pop up when you leave the session.  Please use that to give feedback to CIDER who hosts these seminars or to our presenters.  We will all see the feedback that you receive.  Even if you don’t want to leave detailed feedback, take an opportunity to fill out just a couple of things there and we would definitely appreciate all the feedback that we can possibly get.

Dr. Edelman, Dr. Aron, thank you both so much for giving us a very thorough and entertaining cyber seminar today.  We really appreciate the time you both put into preparing and presenting for today.

David Edelman:  Thank you.

David Aron:  I hope you all had fun because life is much too long not to have fun.  If you’re not having fun, you’re not having it for a long time.

Heidi:  All right.  Thank you.  Thank you to our audience for joining us and we hope to see you at a future HSR&D cyber seminar.  Thank you everyone.

David Aron:  Bye bye.

Heidi:  Bye.

David Edelman:  Bye.

**[End of Recording]**

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