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Sharing Clinical Notes with Patients: Benefits, Ri ...
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Hello and welcome. I'm Tristan Grindow, Deputy Medical Director and Director of Education for the American Psychiatric Association. I'm pleased that you're joining us for today's SMI Advisor webinar, Sharing Clinical Notes with Patients, Benefits, Risks, and Challenges. SMI Advisor, also known as the Clinical Support System for Serious Mental Illness, is an APA and SAMHSA initiative devoted to helping clinicians implement evidence-based care for those living with serious mental illness. Working with experts from across the SMI clinician community, our interdisciplinary effort has been designed to help you get the answers you need for your patients. Now, I'd like to introduce you to today's faculty, Dr. Charlotte Bleas. Dr. Bleas, a former Fulbright Scholar at Harvard Medical School, is currently a Keen Scholar at OpenNotes at the Beth Israel Deaconess Medical Center and Harvard Medical School. She's passionate about public understanding of medicine and healthcare. Dr. Bleas is an interdisciplinary health researcher who's published numerous articles in peer-reviewed journals and books, and has also been consulted by BBC TV and radio. In 2012, she was the winner of BBC Radio 3's New Generation Thinkers Award. Charlotte, welcome to SMI Advisor, and thank you for leading today's webinar. Thank you. I'm very happy to be here talking to you about sharing clinical notes with patients. First of all, I want to begin by saying I have no relationships or conflicts of interest related to the subject matter of this presentation. So learning objectives today are multiple. We're going to begin by talking about this neologism, OpenNotes. What does it mean? Then I'm going to move on to discuss what the evidence base is in relation to sharing clinical notes. So what do patients understand and what do they think about sharing clinical notes? What do clinicians perceive about this whole practice? We'll look at sharing clinical notes in outpatient primary care context, but also in psychiatric and psychotherapy context as well. I'll then move on to look at the limitations and the current gaps in knowledge, so where we're at. Then, number four, I'll turn to the ethical considerations. So it's sometimes said that sharing clinical notes is just the right thing to do, and we'll interrogate that claim to see just what it might mean, ethically speaking. Then we'll move on to discuss the regulatory landscape very briefly, followed by closing and discussing implementing OpenNotes. So first of all, what is OpenNotes? OpenNotes, sometimes written, is sometimes contracted to one word or just the phrase OpenNotes. It's a neologism that refers to the practice of sharing the electronic medical records, including the narrative clinical notes with patients. Sometimes the assumption is made that this is a software or a product, and that's not the case. That was an assumption I initially made myself. But it's just referring to this practice, so we see that in publications. It's also not a new idea. So the earliest proposition in relation to sharing clinical notes, it was located with Schenken and Warner in New England Journal of Medicine, 1973, where they said that for serious problems, maintaining a high quality of care, establishing mutually satisfactory physician-patient relations, ensuring continuity, and avoiding excessive bureaucracy could be alleviated in part, they said, if patients were given copies of their medical records. Today, we're going to look at the first three of those, so the idea of maintaining high quality care, in particular, this idea that it could be a patient safety mechanism. We'll also look at the relational aspects of care, so what is sharing clinical notes do to patient engagement and to trust, and we'll consider this idea of continuity of care, whereby the clinical encounter is extended, if you will, online. Also draw your attention to this second quotation by Kosky and Burns, 1995. This referred to a small study conducted in the UK with 40 patients in a psychiatric inpatient unit who were invited to read their clinical notes, and the authors concluded that sharing clinical notes with these patients was empowering, and that open access was a move towards a more equal collaborative relationship. The final quote there is from a literature review of those small-scale studies that were conducted in the UK and the US in the 1980s and early 90s, mostly with showing hard copies of clinical records to patients, and the authors concluded that most of the reservations that professionals had in giving psychiatric patients were simply not borne out. I also wanted to show you just what sharing the notes via a portal would look like, so here on the left, we have the entire narrative report, including active medication list and so on. The note on the right is a social work clinical note, and you can see that it has the clinical data. It has a review, a report of what went on in the session, followed by the mental state examination and the clinical assessment. Open notes, I should also differentiate the practice of open notes from the philanthropy-funded research initiative of which I am part, based at General Medicine and Primary Care Research at Beth Israel Deaconess Medical Center, Harvard Medical School, which has really been pivotal in launching this research project and, as a result, the practice of open notes, certainly in the US context and internationally, it's been a major player there as well. Open notes as a research initiative is committed to patients having fully transparent access to clinical notes and to open communication among patients and families and health professionals, certainly with respect to the clinical notes. So while the goal is to study the effects of note reading among clinicians and patients, it's also important to point out, while it is a value-based research unit, it is an endeavor as a Harvard-affiliated program, it's a self-critical enterprise, so it's exploring where the evidence takes us, what we can do to overcome possible challenges with clinical note sharing. I want to also show you that the open notes hosts a website, opennotes.org. It's an award-winning website that has excellent resources for patients, for health professionals. It has information on implementation of clinical notes, information for mental health professionals, frequently asked questions. It's a really important repository, including for curating research articles on open notes. So I really encourage you to take a look at that. So I want to turn to the history of open notes. So where did this all begin? It began in 2010 with a pilot study that was initiated by Tom Delbanco and Jan Walker at Beth Israel. And the idea was to share clinical notes with patients for one year across three disparate health care systems. So Beth Israel, a teaching hospital in Boston, Geisinger Integrated Health System in rural Pennsylvania, and Harborview Medical Center in Washington. It involved over 100 primary care clinicians and 20,000 patients. So what did they find? Well, the results were really striking. This is the publication that was published two years later in 2012, Annals of Internal Medicine. They find that more than two thirds of patients reported better understanding their health care, taking better care of themselves, doing better with their medications or feeling more in control of their care. And 20 to 42 percent reported sharing their clinical notes with others, so family, friends and so on. Only one to eight percent, that depends on the locality of the survey, reported being confused, worried or offended by what they read. And more than 85 percent said that open notes would influence their choice of future providers. Also importantly, 99 percent said that they wanted the practice to continue after the 12 month period. So what about clinicians? Clinicians reported minimal workflow burdens, such as increased email traffic or phone calls. And that was, in a sense, corroborated by objective measures of there wasn't an increase in email traffic. Also, interestingly, anecdotal evidence here, but the investigators said that many of the clinicians involved in the study were sceptical that the study had in fact launched because they were so surprised by the lack of or that they weren't being deluged by patients making inquiries about what they read in their clinical notes. Another important study from primary care context, this was by Klein and colleagues published two years ago, was looking at the differentiating between the perceptions of patients with mental health diagnoses and those without mental health diagnoses in a primary care context and seeing how their perceptions of open notes differed. And in fact, the study authors find that there was no significant difference between patients, depending on whether they had this mental health diagnosis. So the majority reported that seeing their notes, reading their notes was important for taking their medications as prescribed. You can see around 80 percent said that reading notes was important for taking better care of myself, for being better prepared for visits. You'll see as well that 8 percent of the respondents with a mental health diagnosis reported being more worried as a result of reading the notes. It was 5 percent for participants with no mental health diagnosis. But after adjusting for independent variables such as race and sex and education, there was no significant difference there. But 40 percent, around 40 percent of both patient groups were concerned about privacy. So where have we come from since these kind of pilot projects? Well, in the US, there's now over 44 million patients who have access to their clinical notes. And the current details are that 212 health care organisations have implemented or are piloting note sharing in the US. At least one private, non-governmental health care organisation in each state is sharing clinical notes. And the entire VA system, through the blue button, functions since 2013. It's an international movement. So health institutions in over a dozen countries now, including Australia, Canada, Denmark, Estonia, Sweden, provide access to clinical notes. In some countries, this is rather advanced. So, for example, in Sweden, most citizens now have access to their clinical notes via patient portals. Certainly fewer do provide access to mental health notes written by psychiatrists, psychologists, psychotherapists and social workers. But it wouldn't be correct to say that this is, you know, a very narrow or marginal practice either. So, for example, the VA opens up all of its inpatient mental health notes to patients. And within North America, around a quarter of the health networks, that's 59, open their, of those networks that open clinical notes, around a quarter open their mental health notes to patients. And in Sweden, around half of the regions currently share mental health notes with patients. So what do we know about sharing clinical notes? So, as I say, I'll parse this between the patient perspective on things and the clinician's perspective on things. So, first of all, patient's perspective. This is the most extensive study that's been conducted to date. So patient, this is a study that was conducted in a sense as a follow up to that initial pilot project across the three different US health systems. So this is open notes after seven years of the publication, patients experiences with their ongoing access to clinicians outpatient visit notes. And the study involved, it was a really extensive study, it involved 137,000 patients who were invited and the response rate was 22%, which is pretty typical for an online survey. 22,000 patients reported reading at least one or more of their notes in the last 12 months, half had read at least four notes. And as you'll see, the findings are really quite impressive. So around three out of four patients said that the notes were important for taking care of their health. 70% said note reading was important for feeling in control of their care. Around two in three patients said that reading the notes was important for remembering the plan of care, for having an active role in their care and for making the most of their visits. And one in two said that the notes were important for preparing for office visits. Also, quite surprisingly, less educated minority, older patients, those who don't speak English at home, were more likely to report benefits from note reading. 40% shared their notes with someone else as well. And when it came to those anticipated anxieties and harms, 3% reported being more confused as a result of reading their notes and 5% were more worried as a result of reading their notes. However, 98% thought sharing notes was a good idea and over 60% said that it would be important for choosing a future provider. Another publication that emerged from that study was the benefits related to medications. So 19,000 of those 22,000 respondents, that's eight out of 10, reported looking at their medication list at least once in the last 12 months. And you'll see, again, really impressive findings here. Two out of three said that reading their notes helped them to understand why a medication was prescribed and made them feel more in control of their medications. 57% said that reading their notes helped answer questions about the medication. 45% said that reading notes helped them understand the possible side effects. And around one in three said reading notes helped them to seek or made them seek more information about their medications. I think the 14% here is really important as well. So 14% said that after reading their notes, they were more likely to take their medications as prescribed. And as Catherine de Roos, the study author, pointed out, you know, 300 billion dollars every year is sunk from the failure of patients to take medications as prescribed. So the potential to represent not just an important saving in a sense intrinsically to patient care, but also the fiscal savings, I think, are a huge potential. And many of these surveys also include open comment boxes. And I think that this is an opportunity to sort of get a more nuanced perspective. So I wanted to give some examples of what patients say. So you'll see that patients do describe or do report being feeling more empowered, more knowledgeable as a result of reading their notes, but also report relational benefits. So, for example, the second quote, the note helps me feel that my doctor and I are partners in promoting my health. Another patient saying, I feel like someone cared may seem quite simple, but it was a nice human touch. Another patient saying, I like reading the notes because they keep me uplifted. Next is a really important psychiatric patient survey. And this is the first open note survey in an outpatient psychiatric setting. It included it was a 20 month long pilot study conducted at Beth Israel involving 15 clinicians, most of whom were psychiatrists under 45 patients. I think it's important to point out in this survey that the clinicians did select the patients. So mostly the patients were those with a diagnosis of depression or an anxiety disorder. Having said that, and it is a small scale study, the results were pretty positive. So we see that 31 out of those 45 patients, 69 percent reported better understanding their mental health, remembering their plan for mental health care and also few. So in a sense, replicating what we've seen, fewer patients worried. So two in this study was four percent. Four were were offended by what they read. Nine percent. And again, this concern about privacy. So 18 percent in this study. Having said that, again, the vast majority of patients, 98 percent wanted to continue access to their mental health notes via their patient portals. Another interesting study just published last year by my colleague, Steve O'Neill was again conducted among clinical social workers at Beth Israel and an affiliated community health centre. It involved 85 patients, 24 percent response rate. More than half of these patients had major depression or bipolar disorders or mild or atypical depression. And on a scale of zero to 10, where 10 was extremely important, patients rated. So you'll see here these figures are from seven plus. 58 percent rated the notes as important for feeling in control of their care. Again, around half the participants said reading their therapy notes were important to trust their provider and for feeling engaged in therapy. And as a result of reading their notes, one in three said they trusted their therapist more. But also, I think really interestingly, the majority just felt no change as a result of reading their notes. And one quarter said they talked with their therapist more openly as a result of reading their notes. Again, some examples from interviews, and these are in fact from interviews, where patients have reported some of those, again, those relational benefits, feelings of validation. I felt my therapist was really listening to me. Another, I always appreciate how well my therapist captures what I've said and how I'm feeling. Importantly, I think it is worth emphasizing that not all patients' experiences in the context of psychotherapy were positive. So it seems that the notes, several studies now suggest that for the vast majority of patients, reading psychotherapy notes, it can really strengthen trust in the provider, but it also has the potential to strain that trust. And that seems to be dependent on the patient's perceptions of the accuracy of the notes and how well-respected they feel from what they read in the content of the notes. So here are some examples. The therapist said only supportive things to me, but the notes seemed judgmental in a negative way. After reading it, I felt badly, like she didn't like me as much as I thought. Another example, I felt uncomfortable that she told me one thing, yet I read something else in the note. So we see this theme of incongruence or inconsistency between the face-to-face appointment and what is communicated in the notes as an important theme when patients feel things have gone wrong. And then there are these issues again of privacy. I just hope, said one patient, that the patient's site is very, very secure. Another case study I want to close from this perspective is the Ontario Shores Centre for Mental Health Sciences study, which Ontario Shores is a 346-bed public teaching hospital in Ontario. And it has a wide range of assessment and treatment services, including for those living with complex and serious mental illness. And they undertook a case study in December 2014. And they found, again, they looked at the pre- and post-enrolment in the patient portal. So they looked at these differences as a result of letting patients see their clinical notes. And if anything, there were slight improvements in mean scores across domains, such as perceptions about self- empowerment, basic functioning, overall sense of well-being, new potentials, advocacy, enrichment, and so on. So the clinician's views. What do clinicians take on all of this? And this is the clinician's perspective, the survey that emerged from the seven years after open note studies led by Jan Walker. And as you'll see here, that in fact, this was the clinicians in psychiatry, which is the gray column in this chart, the gray bar, there was only 22 clinicians in psychiatry in this particular survey. But you'll see that the differences are very, very minor. There's really no significant difference here. Most clinicians agree that sharing the notes is a good idea, that the notes are useful for engaging patients in their care. And the majority of clinicians would recommend note sharing. There is this question, recurrent anticipation that this is going to be an added workflow burden. 96% of psychiatric clinicians in the survey said that patient contact with them was less than monthly or never with follow-up questions about their notes. Around 60% of all clinicians all clinicians said they spent the same or less time in documentation. Of those saying that they spent more time, a minority 4% said they spent much more time writing notes and a third said they spent somewhat more time. So the indicators are that it's not majorly disruptive when it comes to the process of documentation. Having said that, clinicians, and this is a survey on published data of mental health clinicians, so this includes social workers, psychiatric clinicians, and psychotherapists, they do report changes in documentation. So knowing that patients read the notes, clinicians do change what they write. So we see that 25% say that they change use of jargon. Around one in three say that they change terms like patient denies, change that to patient states. Around half say that they change language perceived as critical to the patient, that they change how they write differential diagnoses, that they use partnering language, around a third say that they change how they rate patient preferences and concerns, and 50% say they change how they report sensitive clinical information. Here, again, you can see some of those comments that clinicians give. I'm more aware of the notice and opportunity for homework in between sessions to ensure that my guidance is clear and forthright, which is an indicator of the use of the notes as a tool, a therapeutic tool in a sense, and as a reminder to patients. Another saying, I keep the focus on symptoms. Another participant said, I no longer include information that I think would be useful to other clinicians caring for the patient, but the patient would view negatively. Another saying that if clinical documentation is going to interfere with therapy, I truncate it. So in all, do mental health clinicians perceive these changes as devaluing or diminishing the value of the notes? And 60% said that they believe that the note sharing had no effect or increased the value of their notes to other clinicians. However, 28% said that the notes were somewhat less valuable, and 13% said they believe the notes were much less valuable. I also wanted to highlight that there does appear to be a clinician-patient disconnect in how clinicians perceive patients' perceptions of the notes. So around 40% of clinicians believe that the notes would be more confusing than helpful for patients. However, studies do show that only 5% of patients believe that the notes were confusing. Similarly, this maybe is less of a disconnect, but around 4 in 10 said that at least one patient reported being offended by something they read in their notes in the past 12 months. Perhaps that leads to a kind of anchoring bias, a colour's opinion about the level of offence in notes, but only 8% of patients did feel offended by something they read. 26% of clinicians said that patients who read their notes were more prepared for visits, but in fact that was double the number from the patient perspective. 50% said reading the notes helped them to prepare for visits. So what about the gaps in knowledge? I think it's important to say that there are limitations with some of these surveys. So certainly they're restricted to small sample sizes in particular for those pilot studies in psychotherapy and psychiatry. As with all surveys, they're limited by self-report. So it may be that patients who are more engaged with their healthcare also respond to these surveys, or those who have a strong opinion either against open notes or for open notes are responding. And in the psychiatric survey, at least there was the survey involved selected patients. There's another question about whether access changes patients' health outcomes. And the last, we're owed another systematic review on this, but the last one published in 2013 suggested that sharing open notes didn't improve health outcomes, neither did it undermine health outcomes, and patients for the most part are positive about the process. There are also questions about whether open notes could be used as a therapeutic tool. That's something that's been suggested by Steve O'Neill in psychotherapy. And the question about whether certain patients, so patients with serious mental illness, should be excluded on the grounds of potential harms. And there are undoubtedly questions there that we don't yet have the answers to. On the other hand, others such as Kan, who published in JAMA Psychiatry 2014, suggested exclusion could increase stigmatization. We have to have strong grounds for excluding certain patients from reading their clinical records. This brings us to the ethical considerations. So in healthcare ethics, professionals are obliged to adhere or to uphold certain ethical precepts. And when we think about open notes and the ethical issues associated with it, we really have to kind of parse that debate according to, index it according to each of these precepts. So you take the first of them, beneficence, so doing, benefiting the patient. We can ask the question, does open notes benefit patients? And this is in a sense where the ethics meets empirical research. I think for the most part, we can see that it does seem to benefit patients. The issue of non-maleficence, so do no harm. There is the question about whether it does harm some patients. And follow up issue is whether this is a kind of discomfort or whether it is a serious harm, such as leading to increased anxiety, for example. There's the issue of patient autonomy. So we do see in survey research that patients feel that they are gaining better understanding about their care. Professional autonomy is also an issue. So whether sharing clinical notes, in a sense, enhances or potentially diminishes the ability of a clinic clinician to carry out their own job. And also the issue of clinician truthfulness. So healthcare professionals have a duty to be open and honest with patients and increasing transparency. Similarly, with trust, confidentiality and privacy, where open notes certainly can influence perceptions of trust and perhaps alert patients to issues about privacy with electronic health records that they may not have considered before. So weighing up the benefits and harms, just to take an example, not go through all of these, but the preliminary evidence does suggest that there are benefits to sharing clinical notes that patients do better remember their care plans and they have increased awareness about their health condition. It seems that there are relational benefits, feelings of validation, greater engagement in care, enhanced trust in clinicians. But as I said, there is evidence of, albeit minimal harms, but some patients, a small minority, are offended by what they read, do feel judged or are more anxious as a result of opening their notes. There is also the potential of harm to the therapeutic alliance, depending on how the notes are written. And the idea that changes to documentation practices is also an issue that certainly deserves further investigation. A question of does this undermine the utility of the notes? Inadvertently, does it undermine the accuracy of the notes? Similarly, we weigh up this idea of autonomy and transparency, so we know it's the duty of the clinician to respect the patient's autonomy and to be open and honest. Strong arguments are required to justify a paternalistic attitude in healthcare, that is to hide those clinical notes. But there is evidence through sharing the clinical notes that patients feel more empowered, they have enhanced understanding. But it may be that for certain patients, there is a justification for hiding clinical notes. Again, we can ask, does open notes enhance documentation practices? Does it render the notes clearer, more comprehensive, and so on? And that may, in fact, be the case. So when it comes to resolving these perceived ethical dilemmas, for example, this tension between we want to be open and honest with patients, but we also worry about the potential harm to patients. And I think one way to get around this is really to reconceive. We need to now reconceive the notes as a multi-purpose tool. So this is something I've argued for with John Torres in a new Lancet psychiatry commentary piece, but it's the idea that the notes are transforming. So they're no longer just a repository of a record of information about the patient, but also not just for communicating to other clinicians, but also need to be understood as a communication tool and potentially a therapy tool as well. So I bring back this idea that the open notes become an extension of the clinical encounter. That being said, patients, perhaps especially patients with serious mental illness, could certainly benefit from greater dialogue about issues around access, use of notes, the potential benefits, but also the downsides and how to raise concerns constructively with clinicians. I also want to briefly touch on the regulatory landscape. So looking backward, looking back to HIPAA 1996, since 1996, it gave patients the right in the US to the legal right to retrieve their record. It's also unclear about how much of the record must be made available. Certainly, it's my understanding, psychotherapy notes don't have to be disclosed according to HIPAA. But HIPAA generally rules that patients should receive their copies of their records within 30 days and for a reasonable fee. The new electronic health record landscape, in a certain sense, renders HIPAA sort of 20th century legislation. But I wanted to alert you to one interesting case. It's the first case in the HIPAA right to access initiative from September last year, which involved Bayfront Health, St. Petersburg in Florida, which had to pay the office for civil rights in the US Department of Health and Human Services $85,000 for failing to provide a mother with timely access to records about her unborn child. So that's the first case of its kind. But with the 21st Century Cures Act, we do see changes. This was signed into the law at the end of 2016. The overarching goal of this act is to advance biomedical innovation and to encourage interoperability, so to make it possible for different electronic health record systems to exchange information easily between providers and also to leverage electronic health records to improve patient care and access to information without special effort. The act also explicitly prohibits information blocking, which it defines as, quote, any practice that interferes with, prevents, or materially discourages access, exchange, or the use of electronic health information. And in February 2019, the ONC clarified that information blocking encompasses any impediment to providing patients with free electronic access to their health information. I think worth sort of emphasizing before we move on to the implementation of OpenNotes is that, you know, there is the secular trend now as well, where tech giants are getting in on health care, and we're seeing patients, but also consumers in general, in general, wanting rapid, convenient access to their own information. So, when it comes to transparency in a certain sense, the train has left the station. So, what about implementing OpenNotes? I wanted to close with this example from Ontario Shores, which aimed to promote the use of portal use among patients and staff, and it did so by having peer support specialists. These were staff members who had lived with the experience of mental health issues, and it was their role to promote the portal to patients and to conduct training sessions, but also to provide both perspectives on sharing clinical notes. So, both the patient's perspective and the clinician's perspective to sort of encourage dialogue around this issue, and they did conduct training sessions to oversee this whole process. You'll see different examples such as this case study on the OpenNotes website, where you'll see, as I said, a lot of resources for implementation, for dealing with issues when it comes to writing clinical notes, so how to write sensitive clinical notes or notes around certain sensitive, challenging issues for patients, and lots of resources and assistance online there. I want to leave with some final thoughts. So, to really underline that most patients do want access to their clinical notes, even if they don't read them. Patients report strengthening of the therapeutic alliance as a result of accessing their clinical notes. Most patients report that. The notes can be used as a tool in the therapy toolbox, and I owe that to Steve O'Neill, and OpenNotes could be used. It has the potential to combat shame and stigma. So, there's great capacity in how the notes are written for improving or certainly changing relational aspects of care, and I guess I just want to finish with the, you know, don't be left behind. This is a practice that is increasing, and I'd be happy to take your questions. Thank you.
Video Summary
In this video, Dr. Charlotte Bleas discusses the practice of sharing clinical notes with patients, also known as OpenNotes. She starts by introducing OpenNotes as the practice of sharing electronic medical records, including narrative clinical notes, with patients. Dr. Bleas explains that OpenNotes is not a software or product, but a practice that has been around since a proposal from Schenken and Warner in 1973. She discusses the benefits of OpenNotes, such as increased patient understanding of their healthcare, better patient engagement, and improved medication adherence. Dr. Bleas also addresses the concerns and challenges associated with OpenNotes, including potential harm to patients, changes in documentation practices, and the need for patient and clinician dialogue. She highlights survey findings from both patients and clinicians, which show positive overall perceptions of OpenNotes. Dr. Bleas concludes by discussing the ethical considerations, regulatory landscape, and implementation of OpenNotes, emphasizing the need for clinicians to reconceive clinical notes as a multi-purpose tool and to ensure patient access to their healthcare information.
Keywords
Dr. Charlotte Bleas
OpenNotes
clinical notes
patient engagement
medication adherence
ethical considerations
regulatory landscape
healthcare information
Funding for SMI Adviser was made possible by Grant No. SM080818 from SAMHSA of the U.S. Department of Health and Human Services (HHS). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, SAMHSA/HHS or the U.S. Government.
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