A Research Agenda to Advance the Study of Implementation Mechanisms
January 28, 2025Speaker: Cara C. Lewis, PhD
Date: November 1, 2024
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- 00:01And so on.
- 00:03We're very happy to have
- 00:04you here as well as
- 00:05all of us from the
- 00:06United States.
- 00:07I'm I'm Donna Spiegelman. I'm
- 00:09director of our Center on
- 00:10Methods for Implementation
- 00:12and Prevention Science.
- 00:14I'm professor of
- 00:17Public Health.
- 00:18And I'm very pleased to
- 00:20have as our, center's,
- 00:22guest,
- 00:23for our seminar today, doctor
- 00:25Carol Lewis,
- 00:26who is deputy director of
- 00:28the Center for Translational
- 00:30Research and Implementation Science, otherwise
- 00:33known as CITRIS, at the
- 00:34National Heart, Lung, and Blood
- 00:36Institute at the National Institutes
- 00:38of Health of the United
- 00:40States.
- 00:41As CITRIS is,
- 00:43going to be offering
- 00:45a a full day of
- 00:47of, activities at the upcoming
- 00:50dissemination and implementation
- 00:52of science re conference in
- 00:54December, and so we encourage
- 00:56all of you to attend
- 00:57that as well.
- 00:58Doctor Lewis has a PhD
- 00:59in clinical psychology with a
- 01:01research focus on advancing pragmatic
- 01:04and rigorous measures and methods
- 01:06for implementation science and practice.
- 01:09She has pushed the field
- 01:10to focus on measurement quality
- 01:12to improve the field's research
- 01:14rigor and generalizability.
- 01:16Her work has led the
- 01:17field in considering nuances
- 01:20of health systems, organizations, and
- 01:22individual change
- 01:23in how evidence based interventions
- 01:26can be more effectively
- 01:28implemented and sustained
- 01:29to benefit patients and the
- 01:31general public.
- 01:33Doctor Lewis' expertise
- 01:34in implementation
- 01:35science is evidenced through national
- 01:38and international
- 01:39responsibilities.
- 01:41Ally, can you please keep
- 01:42an eye on having everyone
- 01:43be muted?
- 01:44Her national and international
- 01:46responsibilities,
- 01:47including
- 01:48serving as president of the
- 01:49Society for Implementation
- 01:51Research Collaboration, otherwise known as
- 01:54CERC, which is how I
- 01:55first met her when she
- 01:56invited me to give a
- 01:57talk at the SERC
- 01:59meeting maybe five or six
- 02:01years ago. She's also cofounding
- 02:03editor in chief of the
- 02:04journal Implementation
- 02:06Research and Practice.
- 02:08She's a lecturer for implementation
- 02:10science training institutes,
- 02:12a scientific adviser domestically and
- 02:14abroad, and coeditor of Practical
- 02:16Implementation
- 02:17Science.
- 02:18And in twenty twenty two,
- 02:19she was recognized
- 02:21by Clarivate as one of
- 02:22the most highly cited social
- 02:24scientists in the world.
- 02:26Doctor Lewis has been a
- 02:27driving force in elevating the
- 02:29importance
- 02:30of implementation
- 02:31mechanisms,
- 02:33emphasizing how studying mechanisms of
- 02:35change may improve tailoring, optimizing,
- 02:38and scaling
- 02:39of effective implementation
- 02:41strategies,
- 02:42a topic that's of great
- 02:43interest to us here in
- 02:44our center, both, in terms
- 02:47of,
- 02:48advancing methodology
- 02:49for mediation analysis
- 02:51and using this sort of
- 02:52information to improve
- 02:54the optimization
- 02:55of implementation studies as they
- 02:57go through the design logo
- 02:59that we're working on. So
- 03:00I'm very pleased to turn
- 03:02the,
- 03:03meeting over today to doctor
- 03:05Lewis who's gonna talk about
- 03:07a research agenda to advance
- 03:09the study of the
- 03:11mechanisms.
- 03:12And, well, doctor Lewis is
- 03:14open to people,
- 03:16speaking up if they have,
- 03:19a clarifying question while she's
- 03:21talking,
- 03:22and then you can put
- 03:23sort of more opinion and,
- 03:26questions of a of a
- 03:28sort of far ranging
- 03:30nature in the chat, and
- 03:31then we'll go through them
- 03:32at the end of the
- 03:33talk along with any questions
- 03:35that any of you have
- 03:36at the end of the
- 03:37talk. So with that, I'd
- 03:39like to turn things over
- 03:40to doctor Lewis.
- 03:43Thank you, doctor Spiegelman, for
- 03:45the kind invitation
- 03:46and introduction.
- 03:48And, absolutely, I'm hoping that,
- 03:51I can address any clarifying
- 03:52issues that might arise. It
- 03:53sounds like we have a
- 03:54really diverse,
- 03:55set of backgrounds in our
- 03:57audience today. I see some
- 03:58old and new friends. So
- 04:00thanks for joining us. I'm
- 04:02delighted. This is the first
- 04:03time
- 04:04we'll have, a significant amount
- 04:06of minutes to actually unpack
- 04:08the process that led to
- 04:09and then the results of
- 04:11developing a research agenda to
- 04:12advance the study of implementation
- 04:14mechanisms.
- 04:16And so importantly,
- 04:18I don't have anything to
- 04:19disclose and that the contents
- 04:21of the presentation today are
- 04:22not to be construed as
- 04:24representing the official position of
- 04:26NIH or the Department of
- 04:27Health and Human Services here
- 04:28in the United
- 04:29States.
- 04:31I thought it was important
- 04:32to remind us all
- 04:35why we're here in terms
- 04:36of thinking about implementation science
- 04:38and,
- 04:39implementation
- 04:40mechanisms. And so,
- 04:43folks might recall back in
- 04:45two thousand and one when
- 04:46the institutes of medicine in
- 04:47the United States made this
- 04:48urgent call for fundamental change
- 04:51to close the quality gap.
- 04:52And,
- 04:53the book featured on the
- 04:54screen on the left here
- 04:55recommended a sweeping redesign really
- 04:57of the American health healthcare
- 04:59system
- 05:00and provided four overarching principles
- 05:02for specific direction.
- 05:04One of those four principles
- 05:05were key steps to promote
- 05:07evidence based practice,
- 05:09integration, and strengthening clinical information
- 05:12systems.
- 05:13And then in two thousand
- 05:14and eight, the Institute of
- 05:15Medicine
- 05:16put, together this, also this
- 05:19publication of To is Human,
- 05:20where they broke the silence
- 05:22around medical errors and their
- 05:23consequence and set forth a
- 05:25national agenda to improve,
- 05:27patient safety through the design
- 05:29of a safer health health
- 05:31care system. So these are
- 05:32some of the inspirations
- 05:34for this formal field of
- 05:36implementation
- 05:37science, coming to be. In
- 05:39addition to the publication that
- 05:41and colleagues put out in
- 05:43two thousand and nine where
- 05:44they,
- 05:45feature this leaky pipeline of
- 05:47research that helped to explain
- 05:49a very commonly cited,
- 05:52statistic that,
- 05:55a small percentage of our
- 05:56research takes,
- 05:58up to seventeen years for
- 06:00effective interventions to become routinely
- 06:02available to patients. And you
- 06:04can see some of the
- 06:05reasons for that time lag
- 06:07and then the leak in
- 06:08this pipeline on the image
- 06:10on your screen.
- 06:12I'm delighted to say that
- 06:13we are approaching twenty years
- 06:15of implementation
- 06:16science at the National Institutes
- 06:18of Health.
- 06:20What you see on this
- 06:21slide is,
- 06:22what is fondly referred to
- 06:24as the PAR twenty two
- 06:25one zero five, which,
- 06:27is a funding mechanism for
- 06:29independent investigator
- 06:30initiated applications,
- 06:33both in the United States
- 06:34also with foreign components, but
- 06:36also for foreign investigators.
- 06:38And you can see just
- 06:39how many of the institutes,
- 06:41centers, and offices at NIH
- 06:43have signed on to this
- 06:44program announcement. And later in
- 06:45my talk, you'll see that
- 06:46this week, we've renewed this
- 06:48for another,
- 06:49another term, which I'm really
- 06:50excited about.
- 06:52But,
- 06:53just to make sure we're
- 06:54on the same page, implementation
- 06:56science is the scientific study
- 06:58of the use of strategies
- 07:00to adopt and integrate,
- 07:02evidence based health interventions into
- 07:04clinical and community settings to
- 07:06improve individual outcomes and benefit
- 07:09population health.
- 07:11Now I have permission from
- 07:12the gentleman in the right
- 07:13hand corner of my screen,
- 07:15doctor David Chambers, who's the
- 07:17deputy director for implementation of
- 07:18science at the National Cancer
- 07:20Institute,
- 07:20to share how he characterized
- 07:22our field when he and
- 07:23I did a plenary session
- 07:25at SERC,
- 07:26several years ago now. And
- 07:28so, briefly, in the two
- 07:30thousands,
- 07:31right on the heels of
- 07:32that, funding opportunity,
- 07:35we saw a great deal
- 07:37of emphasis on trying to
- 07:38explain and understand the gap
- 07:41between what we know from
- 07:42scientific evidence and then what
- 07:44we see in practice.
- 07:46And, one of the seminal
- 07:48articles that came out during
- 07:50that decade of implementation
- 07:52science is featured at the
- 07:53bottom here,
- 07:55published by Laura Damschroeder and
- 07:56colleagues.
- 07:57This is referred to oftentimes
- 07:59as the CFIR, the consolidated
- 08:01framework for implementation research.
- 08:03And what they did was
- 08:04they took together these determinant
- 08:06frameworks or frameworks that characterize
- 08:09barriers and facilitators to implementing
- 08:11evidence based interventions,
- 08:14and they organized them into
- 08:15five domains. And I think
- 08:16it was forty seven constructs
- 08:18including sub constructs. And these
- 08:20are things like
- 08:21inner setting, culture, and climate
- 08:23of a health system or
- 08:24even an educational setting if
- 08:26that's the target of an
- 08:27evidence based in, intervention
- 08:30integration effort,
- 08:32to outer setting characteristics such
- 08:34as policies, but also, of
- 08:35course, characteristics of individuals,
- 08:38the process, and the intervention
- 08:39characteristics themselves.
- 08:41So we saw a lot
- 08:42of these publications
- 08:43on characterizing,
- 08:46contextual factors that might help
- 08:48or hinder the integration of
- 08:49an evidence based intervention.
- 08:52Fast forward ten years or
- 08:53so,
- 08:54implementation
- 08:55scientists started grappling with, well,
- 08:57what works? We know what
- 08:58gets in the way. What
- 09:00are the methods or techniques
- 09:01that we need to deploy
- 09:03in order to either resolve
- 09:05those barriers or leverage those
- 09:06facilitators
- 09:07and have success in terms
- 09:09of fidelity to an evidence
- 09:11based intervention?
- 09:13And here, I saw that
- 09:14doctor Powell is with us
- 09:15today. So if you have
- 09:16any questions about implementation strategies,
- 09:18direct them to him.
- 09:19But he was important in
- 09:21leading the charge on a
- 09:23compilation of, strategies for implementing,
- 09:26clinical inner innovations in health
- 09:28and mental health and subsequently
- 09:30in twenty fifteen updated this
- 09:32compilation that folks might be
- 09:34familiar with, and referred to
- 09:36as ERIC, the experts for
- 09:37implementing,
- 09:40interventions recommending change. The mark
- 09:41of a good acronym is
- 09:42you can't remember what it
- 09:43stands for. But so ERIC
- 09:45is on the street, and
- 09:46a lot of people use
- 09:47this as a menu for,
- 09:50selecting strategies to overcome these
- 09:52obstacles for implementation.
- 09:55And now in the twenty
- 09:56twenties, we're starting to see
- 09:57more of and and we
- 09:58hope to inspire you today
- 10:00and in other spaces
- 10:02to be
- 10:03critically evaluating
- 10:05why, how are these implementation
- 10:08strategies working or not.
- 10:10And
- 10:12answering this question of what
- 10:13works best for whom, when,
- 10:15and under what conditions. And
- 10:17I'll talk a little bit
- 10:18more about the systematic review,
- 10:20that we led
- 10:21a few years ago in
- 10:22just a moment.
- 10:24But before we get into
- 10:25that, I thought maybe another
- 10:27way to break this down.
- 10:28What are the factors that
- 10:29we've been exploring? What are
- 10:30we really interested in? What
- 10:32should we be studying?
- 10:33So in this table on
- 10:34the right hand side, we're
- 10:36featuring implementation outcomes. This is
- 10:38not the host of them.
- 10:39These are just some examples.
- 10:41There are at least eight
- 10:42of them that we seek
- 10:43to achieve, but we're here
- 10:45because we want adoption of
- 10:46evidence and evidence based practices.
- 10:48We want to see that
- 10:49they're acceptable, appropriate,
- 10:51feasible to be done in
- 10:52the intended
- 10:54and that they're sustainable,
- 10:56and that they're spread.
- 10:57So this is this is
- 10:58why we're here, implementation outcomes.
- 11:01But then, as you saw,
- 11:02that first decade, we really
- 11:04started to unpack what are
- 11:05the determinants, what are those
- 11:06barriers, what are those facilitators.
- 11:08And, again, these are just
- 11:09a a handful of examples,
- 11:11and they range from the
- 11:13intrapersonal,
- 11:14so in the individual provider,
- 11:16for example, all the way
- 11:17to system level,
- 11:19types of determinants.
- 11:22And then
- 11:23what are the implementation strategies?
- 11:25What are the activities we
- 11:26should be doing? What are
- 11:27the,
- 11:28methods that we should be
- 11:29deploying in order order to
- 11:31overcome
- 11:32those determinants
- 11:33of practice?
- 11:34And then what the focus
- 11:35of today is is on
- 11:37the mechanisms.
- 11:38How are those strategies,
- 11:40working through what process to
- 11:42overcome those determinants to help
- 11:44us achieve those outcomes?
- 11:46And I have permission from
- 11:47this gentleman here featured on
- 11:49your screen, doctor Alvin Gang,
- 11:51to
- 11:52retell,
- 11:53a re
- 11:55a a a retelling
- 11:56of the story of vitamin
- 11:58c and how it surfaced
- 11:59as a cure for scurvy.
- 12:00So,
- 12:01thanks to Elvin. When I
- 12:02heard him describe,
- 12:04in this way,
- 12:06the the retelling of the
- 12:08vitamin c discoveries,
- 12:10I I, was so compelled
- 12:12that it helped us,
- 12:14motivate the study for mechanisms
- 12:16to advance implementation science.
- 12:18Implementation science, so I wanted
- 12:19to share it briefly with
- 12:20you. So as you all
- 12:21know, scurvy was this devastating,
- 12:22disease that killed perhaps two
- 12:24million sailors before the twentieth
- 12:26century, often claiming half of
- 12:27a crew.
- 12:29And as we now know,
- 12:30vitamin c contributes to the
- 12:31formation of the collagenous tissues,
- 12:33a material that keeps your
- 12:34blood vessels, joints, and gums
- 12:36intact, and its absence can
- 12:38be fatal. So in seventeen
- 12:40forty seven, James Linda Surgeon
- 12:42tried an experiment that then
- 12:43made history. Right?
- 12:46So his experiment,
- 12:48went something like this. He
- 12:49got twelve,
- 12:50sailors sick with scurvy and
- 12:52put them into six groups,
- 12:53two in each, and gave
- 12:54each group the candidate treatments
- 12:56that you see here. The
- 12:57two that got citrus recovered
- 12:59dramatically while the others languished.
- 13:01And this final finding is
- 13:02hailed as an early, if
- 13:04not the earliest successful clinical
- 13:05trial, and Lind has gone
- 13:07down in history as a
- 13:08scientific hero.
- 13:10However, the results were not
- 13:11successfully or consistently taken up
- 13:13for fifty to a hundred
- 13:14years, and admissions for scurvy
- 13:16at this typical hospital in
- 13:17Britain continued to be high
- 13:19for at least one hundred
- 13:20years after Lynn's experiment.
- 13:22So here we have a
- 13:23fabulous example of what we
- 13:24now refer to as this
- 13:25no do gap. So it's
- 13:27clear that the citrus theory
- 13:28had far less of an
- 13:29effect than it could have,
- 13:30and this is where implementation
- 13:32science can really come into
- 13:33play.
- 13:34And as with everything that
- 13:35we undertake in implementation
- 13:37science, the truth is far
- 13:38more complicated. So even though
- 13:40Lynn found that citrus led
- 13:42to recovery, no one knew
- 13:43what the mechanism,
- 13:44knew the mechanism, vitamin c.
- 13:47It's tragic in a way.
- 13:49As you can read, Lynn
- 13:50can, himself confesses in his
- 13:52final writings on the topic.
- 13:53He doesn't understand what he
- 13:55observed. And so some ships
- 13:56boiled lemon juice to concentrate
- 13:58it, but that inactivated vitamin
- 14:00c and sailors got scurvy
- 14:01and,
- 14:02casting doubt on the theory.
- 14:04And so in Elvin's words,
- 14:05this is not the story
- 14:06of a man with evidence,
- 14:08but the failure failure of
- 14:09a system to use it.
- 14:11And it's the story of
- 14:12a society that did not
- 14:14understand the mechanism of effect
- 14:15and therefore did not understand
- 14:17how to to use the
- 14:18intervention. So
- 14:19if you're if you're thinking
- 14:20about mechanisms,
- 14:22you won't be making these
- 14:23mistakes, and that's,
- 14:25hopefully what,
- 14:26will inspire more and more
- 14:28study of mechanisms in the
- 14:29implementation science space as we
- 14:32move forward in the field.
- 14:34Other things that inspire us
- 14:36to focus on mechanisms are
- 14:37these quotes that I hear
- 14:39and read about all the
- 14:40time. This strategy works here,
- 14:42but not here.
- 14:44There's no implementation
- 14:45without adaptation.
- 14:47And I think it's hard
- 14:48to,
- 14:49face these realities
- 14:51without centering mechanisms in the
- 14:53conversation.
- 14:54So our our group was
- 14:56so,
- 14:57motivated
- 14:58to,
- 15:00understand mechanisms of implementation
- 15:02strategies. We undertook the systematic
- 15:04review
- 15:05of empirical studies examining,
- 15:07just that.
- 15:08Now before I I share
- 15:10the methods and results of
- 15:11that review, I wanna ground
- 15:13us in in at least
- 15:14how our team was defining
- 15:16mechanisms for the systematic review
- 15:19and the other
- 15:20aspects of the talk today.
- 15:22So the reasons why change
- 15:23occurred or how change came
- 15:25about, so it being a
- 15:26process,
- 15:28they can be,
- 15:30mechanisms can be
- 15:32found through examining mediators.
- 15:34Mediators are not necessarily inherently
- 15:37mechanisms,
- 15:38and, of course, it all
- 15:39depends on your definition and
- 15:41design and things of that
- 15:42nature.
- 15:43But you can read more
- 15:44about,
- 15:45the
- 15:46definitions of of mechanisms in
- 15:48the paper I've put on
- 15:49the screen.
- 15:50I thought another way,
- 15:52based on what Donna was
- 15:54sharing with me about her
- 15:55group of just,
- 15:58depicting
- 15:59mechanisms in the causal chain
- 16:00was to put up this
- 16:02schematic of causal pathway diagramming,
- 16:04and it features all of
- 16:05the terms that I've mentioned
- 16:07to you already. So on
- 16:09the far right hand side,
- 16:11we're striving for some distal
- 16:13implementation outcome,
- 16:15when we bring a strategy
- 16:16into the field.
- 16:17And if we are to
- 16:19center the mechanism of action,
- 16:22we might be able to
- 16:23more,
- 16:24expertly, strongly, swiftly overcome and
- 16:27determinant to get to some
- 16:29proximal
- 16:31signal of success and ultimately
- 16:32to that implementation outcome. Of
- 16:34course, we need to be
- 16:35thinking about moderators, what is
- 16:37amplifying or dampening
- 16:38the impact of a strategy,
- 16:40and to make sure that
- 16:41there are the necessary preconditions
- 16:43in place in order to
- 16:45activate a mechanism. So just
- 16:47another way to think about
- 16:48and,
- 16:49stand up an evaluation of
- 16:51implementation strategy mechanisms.
- 16:54So for the systematic review
- 16:56that was published in twenty
- 16:57twenty, we identified thirty nine
- 16:59studies, and that was as
- 17:00of twenty eighteen. That's when
- 17:01our systematic review analysis ended.
- 17:04Fifty four of those were
- 17:05conducted in the US, so
- 17:07a lot of global work
- 17:08in this space to,
- 17:10study implementation
- 17:11mechanisms.
- 17:12Interestingly, behavioral health settings were
- 17:14the most common,
- 17:15featured in this in this
- 17:17review,
- 17:18followed by hospitals and health
- 17:19systems.
- 17:20Seventy four percent of the
- 17:22empirical studies we included were
- 17:23quantitative in nature. There were
- 17:25a handful of mixed methods
- 17:26and qualitative only, of of
- 17:28course.
- 17:30It's interesting that not all
- 17:31of these studies actually used
- 17:33a theory model or framework
- 17:34to,
- 17:35articulate,
- 17:37and con contextualize
- 17:38their, mechanism evaluation.
- 17:41But of those who did,
- 17:42about seventy four percent,
- 17:44the diffusion of innovations theory
- 17:46featured most with twenty percent
- 17:47of researchers.
- 17:49So,
- 17:51this is a legend that
- 17:52you see on your screen
- 17:53now.
- 17:54You've seen all these terms
- 17:55before implementation
- 17:56strategy, determinant
- 17:58implementation outcome, which, of course,
- 18:00is different than the clinical
- 18:01outcome. And so in some
- 18:03ways, we have two levels
- 18:04of intervention and two levels
- 18:05of outcomes.
- 18:07And then,
- 18:08we're characterizing the mechanism as
- 18:10a mediator in these models
- 18:11you'll see. So what we
- 18:12tried to do is actually,
- 18:16in a in a figure
- 18:17using these shapes and icons
- 18:19is characterize the range of
- 18:22types of mechanism evaluations that
- 18:24the field had contributed,
- 18:26to this point.
- 18:27So in the upper left
- 18:29corner,
- 18:30model one, we saw this
- 18:31in one study where,
- 18:33folks were
- 18:35actually
- 18:36looking at,
- 18:37determinants
- 18:38and then, the change in
- 18:40strategies, which was a little
- 18:41bit interesting and unexpected for
- 18:42me at least,
- 18:45to then change in in
- 18:46determinants of practice.
- 18:48This model two appeared in
- 18:50two different studies, strategy
- 18:52to,
- 18:54outcome to another outcome.
- 18:56And this was the primary
- 18:57model we were interested in
- 18:59seeing where strategies
- 19:00are changing determinants in practice
- 19:03and then yielding the implementation
- 19:04outcomes of interest. We saw
- 19:06this I'm sorry. This is
- 19:08Donna. Just because even I
- 19:09am a I understand all
- 19:11the terms, but I'm not
- 19:12quite sure what determinant of
- 19:14practice means.
- 19:15Sure. Yes. Thanks for clarifying.
- 19:17So determinant,
- 19:19I'm using that as the
- 19:20jargony term for barriers or
- 19:22facilitators. So these are Okay.
- 19:23Those contextual factors
- 19:25that,
- 19:26would otherwise undermine a successful
- 19:28implementation
- 19:29with an example being,
- 19:32something like turnover
- 19:33or implementation
- 19:34climate. Right? Mhmm. Mhmm. Yes.
- 19:37So the idea being that
- 19:39we're often choosing a strategy
- 19:42to address a determinant
- 19:44to then yield that outcome
- 19:46of interest. And it was
- 19:47interesting. We only saw of
- 19:49the thirty nine studies, this
- 19:51particular model showing up in
- 19:52seven of the studies.
- 19:54Otherwise, we're seeing a whole
- 19:56different range of constellations, and
- 19:57I'll just let the screen
- 19:59continue to populate here so
- 20:00you can see the different
- 20:01range of
- 20:03mechanism evaluations
- 20:04among those thirty nine studies
- 20:07here.
- 20:09So then also the last
- 20:11thing I'll say about the
- 20:12systematic review findings is that,
- 20:15if you if you look
- 20:17at the, you know, Seminole
- 20:19Bradford Hill
- 20:21criteria for establishing
- 20:23mechanisms then elaborated on in
- 20:25in later years by Al
- 20:27Kasdan,
- 20:28there are these criteria
- 20:30that's not just single studies,
- 20:32but,
- 20:33subsequent studies of similar mechanisms
- 20:36really need to address in
- 20:37order to have confidence that
- 20:39you've established a mechanism. So
- 20:41things like plausibility.
- 20:42There's a timeline issue. Right?
- 20:44And that's why we think
- 20:45about mediators when we talk
- 20:46about mechanisms.
- 20:48There needs to be association.
- 20:49Ideally, there's manipulation
- 20:51happening,
- 20:52consistency
- 20:53across studies,
- 20:55specificity,
- 20:56that you're able to that
- 20:58you're able to shed light
- 20:59on evidence for a specific
- 21:01mechanism and not others,
- 21:04and then,
- 21:05evidence of a gradient of
- 21:07change. And so you can
- 21:08see that,
- 21:10very few studies were able
- 21:12to address all of these
- 21:13or any of these criteria.
- 21:15So there's work to be
- 21:16done.
- 21:17This is all inspiration for
- 21:18what led
- 21:19us to wanna unpack this
- 21:21line from a to b,
- 21:22strategy to outcome,
- 21:24and, borrowed this comic from
- 21:26Byron Powell and others that
- 21:27I think you should be
- 21:28more explicit here in step
- 21:30two. And so
- 21:31here we go. A little
- 21:32bit more on the motivation.
- 21:34What are the problems we're
- 21:35trying to solve when we
- 21:36think about mechanisms?
- 21:38You know, unfortunately,
- 21:40despite the progress, the twenty
- 21:41years or more of science
- 21:43in this area,
- 21:44we see that, there is
- 21:47still some suboptimal,
- 21:49outcomes in terms of the
- 21:51implementation
- 21:52clinical trials that demand a
- 21:54huge investment,
- 21:56both domestically and abroad.
- 21:58And there's one,
- 22:00example that I like to
- 22:01bring up, the tailored implementation
- 22:03in chronic diseases.
- 22:05This is a multinational
- 22:07study in Europe that took
- 22:09seven years,
- 22:11to come to fruition.
- 22:13And
- 22:14in the introductory
- 22:15article to the special collection
- 22:17that gave us so many
- 22:18learnings in the implementation science
- 22:20space, unfold or, unfortunately, the
- 22:22effects were null in terms
- 22:24of the tailoring,
- 22:26influencing the outcomes they cared
- 22:28about. And Michelle Vinseng, the
- 22:30former editor of implementation
- 22:32science, states that the chosen
- 22:34strategies were not sufficiently matched
- 22:36with targeted determinants or not
- 22:38effective
- 22:39in the targeted groups and
- 22:40settings. So insight into the
- 22:42linkages of interventions and determinants
- 22:44is very limited.
- 22:46So that that's,
- 22:48a more recent,
- 22:49observation
- 22:50that motivates this, and I'll
- 22:52stay back on that slide
- 22:53just for another moment to
- 22:54acknowledge also that,
- 22:57the higher cost and complexity
- 22:59of implementation
- 23:00strategies is sometimes perturbing to
- 23:02me. You know, we've got,
- 23:04we've got such inequities in
- 23:07terms of access to evidence
- 23:08based interventions.
- 23:10And if here we are,
- 23:12designing and testing implementation
- 23:14strategies that cannot be accessed
- 23:16by low resource settings that
- 23:18cannot be scaled because of
- 23:19their cost, I I think
- 23:21we're doing ourselves a disservice
- 23:23and might unfortunately
- 23:24land ourselves with this ironic
- 23:26situation where we've created our
- 23:28own gap between implementation
- 23:30strategy evidence and then implementation
- 23:32practice and what is possible.
- 23:34And then finally, and this
- 23:36is actually more along the
- 23:37lines of what I was
- 23:38just saying,
- 23:39that, inequities
- 23:41could could really be exacerbated
- 23:43when we're really trying to
- 23:44address them and achieve health
- 23:46equity.
- 23:48So practically speaking, we and
- 23:50I always feel like I
- 23:51should say,
- 23:52at least a few things
- 23:53along the lines of why
- 23:55are why is studying implementation
- 23:57mechanisms useful practically,
- 23:59because it does seem like
- 24:01such a scientific sort of,
- 24:04specific,
- 24:05type of evaluation.
- 24:06Well, you've heard me talk
- 24:07about selecting strategies.
- 24:10This is not an easy
- 24:11task. When we do,
- 24:14try to characterize the literature
- 24:16on what are the most
- 24:17common
- 24:18implementation
- 24:18strategies being tested,
- 24:20we see so much of
- 24:21it being perhaps driven by
- 24:23familiarity,
- 24:24you know, groups being or
- 24:25hospital systems being familiar with
- 24:27CMEs. And so what do
- 24:29they do when they need
- 24:29to bring in a new
- 24:30clinical intervention?
- 24:32They offer a CME.
- 24:34But there should be other
- 24:36ways to inform selection of
- 24:38strategies.
- 24:39Unfortunately,
- 24:40and there are other examples,
- 24:42not just familiarity,
- 24:45which is sort of the
- 24:46first that the train and
- 24:47pray,
- 24:48But there's the kitchen sink
- 24:50approach,
- 24:51that relates to the increasing
- 24:52cost and complexity. Let's throw
- 24:54all the strategies we can
- 24:56at the,
- 24:57implementation
- 24:58problems we're facing.
- 25:00We I talked about tailoring.
- 25:02There's and the the opposite
- 25:04of that is a one
- 25:05size fits all approach. And
- 25:06so if we're selecting a
- 25:08bundle of strategies,
- 25:10and using them the the
- 25:11same across context, then,
- 25:14that might not be the
- 25:15best way to to make
- 25:16selections. And then Martin Echols
- 25:18coined the is logiat, which
- 25:21was it seemed like a
- 25:22good idea at the time.
- 25:23And so we can do
- 25:24better, and I think studying
- 25:26mechanisms and centering them in
- 25:28selection is one way to
- 25:29do
- 25:31better. Practically speaking then,
- 25:34part of selecting is matching
- 25:36to the strategies to barriers.
- 25:38So you've heard me talk
- 25:39about determinants multiple times. This
- 25:42is one of the really
- 25:43interesting,
- 25:44outputs from that tailored implementation
- 25:46of chronic disease,
- 25:47multinational study where Kraus and
- 25:49colleagues and forgive me for
- 25:50not having the citation here
- 25:52for you.
- 25:53They discovered six hundred and
- 25:55one,
- 25:57discrete plausible determinants of practice,
- 25:59and they did shake loose
- 26:01across a variety of levels,
- 26:02patient, provider, organization,
- 26:04community, and policy levels.
- 26:07So when you're faced with,
- 26:08you know, I think we
- 26:09see more often fifty or
- 26:11so determinants in a given
- 26:12project. This was across many.
- 26:14But when you're faced with
- 26:15so many determinants, how do
- 26:17you select and match strategies?
- 26:19Especially when then you're faced
- 26:20with seventy or more. I
- 26:22think more recently, we see
- 26:23at least one hundred discrete
- 26:25strategies are available to us
- 26:26for use. And I'm giving
- 26:28you some some examples across
- 26:30plan, educate, finance, restructure,
- 26:33quality management, and the policy
- 26:34context.
- 26:37So then, tailoring is another,
- 26:40approach to implementation,
- 26:42that I've been talking about,
- 26:43and,
- 26:45I'm excited about the work
- 26:46forthcoming from Sheena McHugh and
- 26:49her team. They're characterizing processes
- 26:51and outcomes of tailoring implementation
- 26:53strategies,
- 26:54because, really, there's so much
- 26:56to be,
- 26:57learned and specified in this
- 26:59space. Even the definition of
- 27:01tailoring,
- 27:02has some tension associated with
- 27:04it,
- 27:05and the methods are unclear
- 27:06about how best,
- 27:08to tailor to optimize outcomes.
- 27:10And speaking of optimization,
- 27:12there are a couple of
- 27:13groups, including yours, Donna, who
- 27:15are helping us think about
- 27:16how do we optimize
- 27:18implementation
- 27:18strategies
- 27:19when we're centering criteria like
- 27:22equity or
- 27:23cost or efficiency.
- 27:25How do we streamline? How
- 27:27do we scale implementation,
- 27:30accordingly?
- 27:31So that all of that
- 27:33led us to apply to
- 27:34the Agency for Healthcare Research
- 27:36in the United States, for
- 27:38an r thirteen award. This
- 27:39is a conference grant mechanism,
- 27:42that we fortunately received after
- 27:44our third application.
- 27:45I like to be a
- 27:46humble human and let folks
- 27:47know it takes a lot
- 27:49of tries, right, to get
- 27:50your,
- 27:51grant ideas funded.
- 27:54This was not my record.
- 27:55I think I submitted an
- 27:56r o one four times
- 27:57once before I was successful.
- 28:00But the goals of this
- 28:01r thirteen were to establish
- 28:02the priorities to guide a
- 28:04research agenda on implementation
- 28:06mechanisms and then to share
- 28:07it broadly.
- 28:09The methods we use were
- 28:10multifold.
- 28:11They featured partnership,
- 28:13with SERC,
- 28:14that society that has been
- 28:16mentioned a couple of times,
- 28:18network recruitment,
- 28:19to folks who had mechanism
- 28:21like expertise,
- 28:23and we formed this mechanisms
- 28:24network of expertise in SERC.
- 28:27We then identified challenges,
- 28:30to doing this type of
- 28:31research,
- 28:32did some synthesis work, articulated
- 28:34priorities and possibilities,
- 28:37and are in the dissemination,
- 28:39stage of things.
- 28:40So just wanted to give
- 28:41a nod to the many
- 28:43humans who participated in this
- 28:45effort. I have to acknowledge
- 28:46that they're predominantly in the
- 28:48United States. We had funding
- 28:50limitations to travel people broadly.
- 28:53And, also, as you might
- 28:54have noted with the timeline,
- 28:55this overlapped with COVID, which
- 28:58prevented some of the conference
- 28:59like activities that we had
- 29:01planned.
- 29:02But we kicked things off
- 29:03with a, plenary session at
- 29:05SERC in twenty
- 29:08seven nineteen, it looks like
- 29:10it was,
- 29:11with David Chambers and doctor
- 29:12Nate Williams where we were
- 29:13setting the stage for understanding,
- 29:15sort of trying to get
- 29:16on the same page about
- 29:17implementation
- 29:18mechanisms
- 29:19and what we knew about
- 29:20them and what we might
- 29:21not.
- 29:22And then we had several
- 29:24inputs for this research agenda.
- 29:26So the systematic reviews that
- 29:28existed in this space were
- 29:30among the inputs. We did
- 29:32an exercise we we called
- 29:33matrix mapping. So all of
- 29:35those, folks on the mechanism
- 29:37of expertise in the early
- 29:38days
- 29:39helped share,
- 29:41where they were studying mechanisms,
- 29:43what they knew about them
- 29:44in a really systematic approach.
- 29:47We also listened in on,
- 29:49studies being proposed that were
- 29:51being discussed in these,
- 29:53workshops, and we qualitatively
- 29:55extracted challenges to,
- 29:57doing mechanism evaluations.
- 29:59We hosted breakout sessions at
- 30:01SERC. So some of you
- 30:02might even been in those
- 30:03rooms where we had facilitated
- 30:06conversations, and I know some
- 30:07of our facilitators are on
- 30:08the call today. So grateful
- 30:10for all you did, to
- 30:12solicit information as one of
- 30:13these inputs. And then we
- 30:15actually coded abstracts at that
- 30:17particular conference.
- 30:20And this this was the
- 30:22theme of the CERC conference
- 30:24back in twenty seventeen, actually.
- 30:27Excuse me.
- 30:28And,
- 30:30I should make
- 30:31come off mute to share
- 30:32the methods behind concept mapping.
- 30:35It's a great way to
- 30:36bring together,
- 30:38experts to consider,
- 30:41discrete,
- 30:42pieces of information. In this
- 30:44case, they were considering one
- 30:45hundred and five unique challenges
- 30:48to studying implementation
- 30:50mechanisms,
- 30:51and they were asked to,
- 30:53group them to conceptually distinct
- 30:56piles and help us characterize
- 30:58those,
- 30:59discrete challenges. And this is
- 31:01where we landed in terms
- 31:02of a concept map.
- 31:04And so you can see
- 31:06the challenges to doing this
- 31:07work range from theoretical and
- 31:09causal in nature
- 31:11to the types of methods
- 31:13and designs that are needed,
- 31:15and and and more.
- 31:17So these one hundred and
- 31:19five,
- 31:20challenges were,
- 31:22the springboard
- 31:23for then,
- 31:24our
- 31:26mechanisms research agenda.
- 31:28Just acknowledging that during COVID,
- 31:30we got creative and we
- 31:31met on rocks and stumps
- 31:32in the woods
- 31:34to articulate
- 31:35our research agenda
- 31:36and used a lot of
- 31:37sticky notes to, help
- 31:40clarify priorities and possibilities.
- 31:43So this paper was published,
- 31:45just in September of this
- 31:47year.
- 31:47Another artifact of COVID is
- 31:49that some papers took a
- 31:50little bit longer to get
- 31:52out the door,
- 31:53but I'm delighted to have
- 31:55that out there in an
- 31:56open access journal for folks
- 31:58to consider,
- 32:00as you're thinking about implementation
- 32:02evaluations
- 32:03going forward.
- 32:04I'll spend just a few
- 32:05minutes then on what we
- 32:07featured in that paper.
- 32:09And so how we organize
- 32:10things was,
- 32:12grouping them into what we
- 32:14felt like were,
- 32:15conceptually sort of distinct areas
- 32:17of priority.
- 32:18And then within each of
- 32:20those areas of priority, we
- 32:21had at least two goals,
- 32:23and then
- 32:24we tried to make things
- 32:26concrete and actionable. So we
- 32:28called these possibilities,
- 32:29sort of action possibilities.
- 32:32And so there's a hundred
- 32:33and fifty one action possibilities,
- 32:35for studying implementation
- 32:38mechanisms moving forward, and I'll
- 32:40give you some examples of
- 32:41those.
- 32:42So one of the priority
- 32:44areas
- 32:45is accumulating knowledge within and
- 32:46across disciplines. So,
- 32:49there you know, this included
- 32:51nineteen actions actions that featured
- 32:53specific
- 32:54systematic reviews and meta analyses.
- 32:56When we think about mechanisms,
- 32:58the questions we hope scholars
- 32:59will answer are things like,
- 33:01do mechanisms
- 33:02operate universally,
- 33:04or is there variation across
- 33:05context,
- 33:07that we need to be
- 33:08aware of?
- 33:10Another priority area is,
- 33:12prioritizing mechanism research incorporating other
- 33:14knowledge. So this had eleven
- 33:16possible actions to bring transdisciplinary
- 33:30epidemiology,
- 33:30psychology, and various other disciplines.
- 33:33And so there are named
- 33:35possible actions for how to
- 33:36do that type of work
- 33:38in the table featured in
- 33:39that paper.
- 33:40We another priority area was
- 33:42overcome design challenges and innovate
- 33:44methods. There were eighteen actions
- 33:46here where there's really new
- 33:47methods needed or we need
- 33:49to borrow methods from other
- 33:50disciplines. So
- 33:51modeling time and quantitative assessment
- 33:54for isolating specific mechanisms,
- 33:57identifying underutilized
- 33:58methods that offer specific value,
- 34:00like like comparative case studies
- 34:02that could generate hypotheses about
- 34:04complex mechanistic pathways.
- 34:09Priority area around improving measurements.
- 34:11So measurement of mechanisms,
- 34:13particularly in the context where
- 34:14implementation scientists work is pretty
- 34:17challenging.
- 34:19This included thirteen different actions
- 34:21such as
- 34:22pragmatic approaches for objective data
- 34:24collection,
- 34:25those capturing lived experiences of
- 34:27individuals.
- 34:29Then we have another priority
- 34:31area for providing guidance for
- 34:33specifying mechanisms. There were fifteen
- 34:36actions here reflecting mostly tools
- 34:38and
- 34:39aids to improve researchers' approach
- 34:41to examining mechanisms.
- 34:43I, didn't share this when
- 34:44I was reporting out on
- 34:45the systematic review of mechanisms,
- 34:47but it was really challenging
- 34:50for us as a research
- 34:51team to,
- 34:53synthesize
- 34:54across those thirty nine studies
- 34:56because,
- 34:58most of the
- 35:00studies and their
- 35:02authors conceptualize mechanisms in different
- 35:04ways and conceptualize the causal
- 35:05pathway in different ways.
- 35:07And so,
- 35:09that's just one piece of
- 35:10evidence or example that,
- 35:12having some alignment or harmony
- 35:14around how we're thinking about
- 35:15this could be really helpful
- 35:17moving forward.
- 35:19Another priority area on increasing
- 35:21the focus on theorizing. So
- 35:23there were twelve possible actions
- 35:24here for developing, incorporating, refining
- 35:27theory and mechanistic research to
- 35:29better characterize mechanisms, so making
- 35:32theory explicit even in the
- 35:33strategy design phase.
- 35:35And this is the last
- 35:37group. These were emergent actions,
- 35:39so they,
- 35:40were not
- 35:41similar to the challenges
- 35:43that,
- 35:44fed into the concept mapping.
- 35:46But the group,
- 35:47who articulated the research agenda
- 35:49said just how important it
- 35:51was to engage the policy
- 35:52and practice community,
- 35:54twelve possible actions there,
- 35:57for understanding,
- 35:58the perspectives of these partners,
- 36:01using things like,
- 36:03implementation
- 36:03mapping, cognitive walk throughs to
- 36:06unpack or surface,
- 36:08mechanisms, really needing to plain
- 36:10language this space
- 36:11in order for it to,
- 36:13be engaging and informed by
- 36:15the people who really have
- 36:16the expertise to do so.
- 36:20Another priority area around engaging
- 36:22funders and the need for
- 36:23funding, and so this comes
- 36:25from the mechanisms of expertise
- 36:26saying that,
- 36:28there are seventeen actions that
- 36:29could be happening in this
- 36:31space,
- 36:32to leverage or stand up
- 36:34new opportunities
- 36:35and then building capacity.
- 36:37So, seventeen actions offering
- 36:40clarification or guidance,
- 36:42and avenues to build the
- 36:43field's capacity.
- 36:45And then finally, just this
- 36:46huge emphasis on dissemination.
- 36:48So,
- 36:49several goals listed for you,
- 36:51seventeen actions in the table
- 36:53and the paper. There are
- 36:54specific manuscript ideas that,
- 36:57if you happen to be
- 36:58looking for a paper topic,
- 36:59they're in there for you
- 37:00to consider,
- 37:02but also suggestions around forums
- 37:04to host dialogue,
- 37:07you know, ways to engage
- 37:08journal
- 37:09editors, and
- 37:10failing faster with wisdom was
- 37:11a paper type,
- 37:13that the mechanisms network of
- 37:15expertise came up with. We
- 37:17so often missed the opportunity
- 37:19to learn from null studies,
- 37:20and couldn't we just make
- 37:22that an explicit priority, for
- 37:24example?
- 37:25So,
- 37:26true to form, our mechanisms
- 37:28network of expertise couldn't stop
- 37:30with just articulating the research
- 37:31agenda. Many of them have
- 37:33written papers that address some
- 37:34of the items on the
- 37:35research agenda. So we stood
- 37:37up a special collection across
- 37:39the two,
- 37:40sibling journals, implementation science and
- 37:42implementation science communications.
- 37:44It's an open special collection.
- 37:46So if you're doing work
- 37:47in this space, we hope
- 37:48you'll consider
- 37:49selecting that special collection from
- 37:51the drop down menu and
- 37:52submitting to it directly.
- 37:55And I wanted to feature
- 37:57an article that came out
- 37:58last month by the editors
- 38:01and associate editors, several of
- 38:02them from those two
- 38:03journals where they update the
- 38:05scope,
- 38:06of those two journals. And
- 38:07I I had to highlight
- 38:09that among the,
- 38:10items included in the abstract
- 38:12was the import of the
- 38:13study
- 38:14of of implementation
- 38:16mechanisms.
- 38:17I'll wrap up with a
- 38:18few NHLBI
- 38:20specific,
- 38:21items for you. So,
- 38:23as you can see from
- 38:24my background, I sit,
- 38:26within NHLBI,
- 38:27specifically the Center for Translation
- 38:29Research and Implementation Science.
- 38:31And over the last year
- 38:33or so, we've been wrapping
- 38:34our arms around a ten
- 38:35year investment,
- 38:37in implementation
- 38:38science and making sense of
- 38:40our institute's
- 38:41contributions and that of other
- 38:43ICs,
- 38:44in the National Institutes of
- 38:45Health. And what you can
- 38:47see on the screen on
- 38:48the left here is that
- 38:50the proportion of NIH awards
- 38:52has grown substantially
- 38:53over the last
- 38:55ten years or so,
- 38:57which is very exciting. And
- 38:59NHLBI
- 39:00holds thirteen percent,
- 39:02share of all NIH
- 39:04implementation science awards with fourth,
- 39:07overall for total costs.
- 39:08It's an exciting
- 39:09trajectory to see. And then
- 39:11when we look within NHLBI,
- 39:13that trajectory of increase,
- 39:15is also evident. However,
- 39:18I think you'll find it
- 39:19staggering as do I that,
- 39:22the percent
- 39:23of our total cost for
- 39:24competing awards is about two
- 39:26percent
- 39:27focused on implementation
- 39:28science. So it's not just
- 39:30the study of implementation
- 39:32mechanisms that we need. It's
- 39:33implementation
- 39:34science more broadly, and we
- 39:35hope you'll consider targeting,
- 39:38NHLBI
- 39:39with some of your good
- 39:40grant ideas,
- 39:41in the coming months and
- 39:42years.
- 39:43So as I mentioned, just
- 39:45this week, the new program
- 39:46announcement has been released. I'm
- 39:48just showing you the r
- 39:49l one for for investigator
- 39:51initiated awards here, PAR twenty
- 39:53five one hundred and forty
- 39:54four.
- 39:55Again, US, US with foreign
- 39:57components, and foreign investigators
- 39:59can submit to this.
- 40:01And we're here for you.
- 40:02Right? So the our job
- 40:04is to be available for
- 40:06technical assistance is what we
- 40:07call it, to help you
- 40:09think through the ideas, their
- 40:10alignment with the various institutes,
- 40:13and responsiveness to the program
- 40:15announcements such as this.
- 40:17Donna shared that we're celebrating
- 40:18our tenth anniversary.
- 40:20There's a lot of red
- 40:21around me today.
- 40:22It's a hybrid event. And
- 40:23if you're interested, send me
- 40:25an email.
- 40:26There is going to be
- 40:27a cap, unfortunately,
- 40:28just given size of rooms
- 40:30and ability to host virtually,
- 40:32but you'll email me, and
- 40:33I'll I'll help you find
- 40:34your way.
- 40:36And lastly,
- 40:37we're hiring, and there are
- 40:39several opportunities if you're an
- 40:40implementation
- 40:41scientist looking to have a
- 40:43seat at the table and
- 40:45contribute to,
- 40:46the,
- 40:47strategic vision implementation
- 40:49plan for this work at
- 40:50NHLBI.
- 40:52And if you wanna stay
- 40:53abreast of when those opportunities
- 40:55emerge, follow us on LinkedIn.
- 40:58NIH largely has moved away
- 41:00from Twitter and accent is
- 41:02finding our new social media
- 41:04home in LinkedIn,
- 41:05and this is the, Citrus
- 41:07official page here. So on
- 41:09that note, thank you so
- 41:10much for hanging in there
- 41:12with me. It's a super
- 41:13nerdy topic. Hopefully, I made
- 41:15it accessible, but now is
- 41:17our chance to dialogue.
- 41:20Yeah. Thanks very much, Kara.
- 41:22That was a really excellent
- 41:23comprehensive
- 41:24talk that covered a lot
- 41:25of the key points, so
- 41:27we really appreciate it.