You are on page 1of 11

1 Community Mental Health in the United StatesLessons from our History Delivered at the First International Conference of Psychiatry

in Ramallah, Palestine, October 2012 Elizabeth C. Berger MD, MPhil Michael D. Morse MD, MPA ABSTRACT: This paper reports on the historical development of community mental health in the United States since the 1960s, with a review of its patient population and characteristic system problems, especially the revolving door phenomenon and the challenge of fragmented care. The authors describe participation in subsequent reforms and provide recommendations based on that experience. Recommendations cover principles of clinical and administrative practice, as well as placing community mental health within a public health context. Principles of clinical practice include respect for patient rights, the formation of multidisciplinary treatment teams, and the process of comprehensive psychiatric evaluation. Principles of administrative practice include clear documentation of policy and procedure--especially regarding the management of crises and the boundaries of treatment--effective QA process, and staff development. It will be important to place mental health into an overall agenda for public health with an emphasis on coordination of diagnosis and treatment for mental disorders and general medical conditions. In accordance with WHO and UN recommendations, achieving public health goals, including goals for mental health, will be as dependent upon reducing global risk factors such as poverty and violence; prevention in mental health must be linked with advocacy for social justice.

HISTORY OF THE COMMUNITY MENTAL HEALTH SYSTEM At the beginning of the 20th century, thousands of persons in the United States presumably suffering from mental illness were admitted to state-run psychiatric hospitals, frequently against their will, and confined to crowded, understaffed hospitals for lengthy periods of timeoften essentially imprisoned for their entire life-times. The state hospital was an enormous building or complex, sometimes the size of a small city, set remotely in the countryside. Patients were isolated from their families and routinely subject to physical restraints, forced feedings, electroshock and insulin shock therapy, solitary confinement, medications, experimental brain surgery, and other horrors without their consent. This landscape changed profoundly in the 1950s with the development of the first effective antipsychotic medications such as chlorpromazine (Largactil in Palestine) and a subsequent period of emptying out and closing down these huge state hospitalsbecause many of the patients, once medicated, became well enough to be discharged. In 1965, an important law was passed establishing community mental health centers throughout the United States to provide outpatient treatment in the community to this population of previous inpatients. Instead of the enormous state psychiatric hospitals, the physical treatment setting was relocated to a modest office building in a shopping center or business areathe agency center. The

2 law provided funding for outpatient treatment in these agencies, and thus outpatient psychiatric treatment became available, in theory, to everyone. THE OUTPATIENT POPULATION AND ITS NEEDS The typical state-hospital patient had a diagnosis of chronic schizophrenia but many others would probably be diagnosed with bipolar psychosis, psychotic depression, and organic brain syndromes from a variety of causesespecially substance abuse, head injury, and mental retardation. The original group of community mental health patients were thus persons suffering from severe and persistent mental illness who were managed on antipsychotic medications prescribed by physiciansgenerally psychiatristswho worked as salaried employees at the community agency. These patients resided either with their families or in group homes or in isolated tiny rented rooms surviving on extremely small incomes derived from publicly funded welfare and disability programs. Often they were homeless. In addition to suffering from mental disorders, the patients discharged from the state hospitals of the 1960s faced many practical problems: obtaining food, housing, transportation, education and training. Some of these patients had not ridden a bus or held money in their own hands for forty years and left the environment of the state hospital unprepared for ordinary existence. These patients also faced a multitude of emotional, family-related, and social challenges which resulted not only from the direct effects of their mental disorders but from years of isolation from other human beings. They also often suffered from medical illnesses. Immediately there was a need for community mental health centers to provide a spectrum of supportive social and therapeutic services, extending in scope far beyond a role of the psychiatrist writing prescriptions. The community mental health center was then organized to provide non-physician therapists and case-managersoften social workers or psychologists, and sometimes nursesas counselors to assist patients with practical problems such as housing, food, training programs, legal assistance, and job opportunities and to treat patients for emotional problems such as the lack of social skills, anger management, and problems adjusting to their newly re-discovered families and neighbors. There was also a need for emergency services, insofar as patients discharged from state hospitals often required re-hospitalization to acute care psychiatric units. Here we have the origin of a great tension within community mental health, the integration of social services and talk therapies with pills. A second population of patients soon joined the population of chronically mental ill individuals from the state hospital system as outpatients seen at the community mental health center: troubled families and troubled individuals who were living in the community. This population of individuals may not have been hospitalized psychiatrically, but nevertheless often displayed significant pathology. These patients included children and adolescents who experienced academic failure and behavioral problems and families troubled with domestic violence and substance abuse. A community mental health center thus in theory might offer a wide spectrum of therapy modalities to meet the needs of persons suffering from mentally illness as well as the needs of families and individuals

3 in the community: therapy groups for building social skills, family and marital therapies to resolve conflicts, child therapy, parent counseling, individual psychotherapy, art therapy, occupational training, and other social services as well as medication, emergency triage, and referral functions to inpatient psychiatric units and to the police and court systems. Community treatment programs for substance abuse were often established separately from mental health programs, but represented a therapy modality often relevant to patients seen in community mental health agencies. We must point out here that the United States had throughout its history and still today does not have a coherent health care system or coherent health care reimbursement systemfor any medical condition-- so that patients who lack private health insurance have no funding source to pay for care except for an inadequate patchwork of social programs. Middle-class persons with good insurance see private practitioners. Patients with no insurance or limited insurance have no way to pay for private psychiatrists or therapists as well as no way to pay for general medical care; they go to the community mental health center and public hospitals if these are accessible. Our patients are therefore, by and large, homeless people, poor people, and working people struggling to survive against considerable external hardships in addition to their psychiatric conditions. There were, by the 1970s, well-established outpatient treatment centers delivering mental health services in every large city in the United States and in many small communities. The people who staffed these agencies were often extremely devoted, hardworking and capable, and there were countless patients who received excellent services there. However, the system was characterized by many serious limitations. PERVASIVE PROBLEMS WITHIN COMMUNITY MENTAL HEALTH Characteristic problems have been: lack of access, long waiting lists, inadequate family involvement, abuse of patient civil liberties in involuntary commitment on one hand and neglect of legitimate dangerousness on the other, the well-known revolving door phenomenon of repeated hospitalizations, discharge, and re-hospitalization, poor treatment planning, and especially, a lack of coordinated communication and follow-up regarding ongoing clinical care at every level. THE REVOLVING DOOR The phrase revolving door refers to an especially important problem in which the patient traveled passively from one situation to another, like a work product on an assembly-line: emergency evaluation, hospitalization, discharge to outpatient care, waiting list, outpatient evaluation, case assignment, medication visits, therapy visits, a break in treatment continuity, clinical decompensation, and emergency re-hospitalization. The overall process lacked continuity to a profound degree. A fundamental cause of this confusion lay in its reimbursement structure, such that each work station was its own fee-for-service billing center responsible for a single piece of a larger process. There was no financial incentive for any single entity to manage the patients illness over time or to be responsible for its overall outcome. FRAGMENTED TREATMENTS WITHIN ONE FAMILY

4 The confusion through time, illustrated by the patients transit through the revolving door, was matched by a corresponding confusion through space. Community mental health centers operated as a maze of individual cubby-holes, where the childs psychiatrist would rarely meet with the mothers social worker, and families were often excluded from contact with the index patients clinician and disregarded in treatment planning. Families were often split across various agencies as well. In larger cities in the United States, therapy of various sorts is commonit sometimes seems as though practically everyone is in therapy. Fragments of a family may present for treatment in community mental health when mother is already in therapy in someones office across town and the child is already in therapy in completely different agency; the family then comes to the community mental health center for marital problems or for medication only for the child: Were just here for pills. These split family treatments were notoriously problematic, resource-consuming, and clinically crisis-ridden. These problems became increasingly the focus of protest within the ranks of patients and also clinicians, and publicized through various media; a vigorous self-help and the so-called anti-psychiatry movement arose in response to many of the failures of the mental health system: fragmentation of care, poor communications, and disrespect and abuse of patients as human beings. One of us (EB) was involved professionally in reform efforts within several community mental health centers over a period of several decades, and the following discussion is based on these experiences. REFORMING THE SYSTEM OF CARE IN COMMUNITY MENTAL HEALTH Reforms focus on problems at three levels of organization: the first level is the blue-print of what is done clinically, based in worthy principles of clinical practice. The second is a management model within the agency that supports best-practice, based on worthy principles of administrative management. The third is the way in which psychiatric care is a partor, is not a partof the public health agenda for overall community well-being. These three levels naturally interact, but we will address them separately. WORTHY PRINCIPLES OF CLINICAL PRACTICE RESPECT FOR THE PATIENTS HUMAN RIGHTS The first principle of care delivery is respect for the patients rights, including the right to freedom, to maintain control over ones life generally and to medical care in particular, to full disclosure of information, to clearly defined standards of confidentiality, to give or to withhold informed consent to treatment elements, including research agendas--and the right to the least restrictive treatment setting except under very specific special circumstances involving immediate dangerousness. The patient has a right to not only to the physical medical record but to an ongoing role in determining the goals and course of treatment. Patients are best served when they are active partners in their own medical care, and play an ongoing role in decision-making. This framework helps us to recognize the sources of strength and resilience within the patient and family, and to use these as a basis for treatment success. The second worthy clinical principle: the concept of THE MULTIDISCIPLINARY TREATMENT TEAM AND COMPREHENSIVE TREATMENT PLAN

5 If resources were unlimited, a psychiatrist may devote time to phoning teachers and families, conducting talk therapy, and obtaining records from elsewhere; in private office practice, psychiatrists often do these things. When resources are limited in community mental health however, it is wise to have psychiatrists do only those tasks that require a physicianoverseeing the treatment as a whole, establishing a formal diagnosis, making referrals, and managing medications. Other staff members conduct talk therapy and maintain contact with outside agencies. The problem involved in limiting the role of the psychiatrist in this cost-saving way is that it tends to split the psychiatrist and the pills from the rest of the treatmentwith a loss of information and cohesiveness of the treatment. The doctor doesnt know what is happening in the patients life and the therapist doesnt know what is happening with the pills or the patients symptoms. Clinical care thus suffers. An effective solution is the assignment of each patient at intake to a specific two-person team, consisting of a psychiatrist team leader and a non-psychiatrist therapistwho may be by training a social worker, a psychologist, a nurse, or some other clinician. The psychiatrist maintains overall control and responsibility for the treatment within a medical modelbut the therapist maintains overall contact with the patient, the family, the team psychiatrist as needed, and with all aspects of the patients clinical situation. A basic team consists of two persons, although sometimes additional team members may be added to meet specific needs. Heres how the treatment team works: Each patient who presents for treatment is scheduled for a prompt Comprehensive Evaluation which is documented in a standardized written format. The format serves as a checklist so that significant questions are not inadvertently omitted. Naturally the checklist items are worked into the discussion through the therapists skill and the format of the interview is not driven by the checklist. Much of the information regarding the patients present problem, and the patients history (i.e. personal, treatment, medical, family, legal, substance-related, and work histories) can be gathered and documented by a therapist and then presented to the psychiatrist as a concise summary. The psychiatrist can then complete the comprehensive evaluation with therapist present by interviewing the patient, focusing upon those aspects of the history and present problem which may be especially relevant, and performing the mental status examination. The psychiatrist, the therapist, and the patient then develop a comprehensive written treatment plan and all sign the document. Issues of confidentiality, of documentation, and of treatment modalities and goals can be explored at this time. All information is written into the chart once, and once only. From here, the course is set for medications, for talk therapy such as CBT, group, family, psychodynamic approaches, or other specific therapies. The team also may refer and connect the patient to appropriate community functions such as traditional, religious, political, and social structures as well as to legal supports or substance abuse treatments which are often indicated. The psychiatrist may make referrals for medical studies or medical treatment; these communications are then followed-up by the therapist.

6 In this way, the multi-disciplinary team divides up the projected treatment without duplication or missing elements. But the team shares a common understanding of the patient, which is then adjusted as treatment proceeds. From an administrative perspective, the treatment team establishes a medical model insofar as a physician has met and examined each patient at the point of entry into care and the physician continues to be responsible for the implementation of the ongoing treatment plan. If the patient is to be referred for evaluation and treatment of co-occurring medical problems, the physician sees to it that this in fact takes place, with the therapist providing support ; if the patient is to be given psychiatric medications, the physician meets with the patient AND THE therapist for follow-up visits. If the patient needs to be seen on an urgent basis, the physician either provides this service directly or follows-up on its outcome. If the patient is not in need of medications or emergency follow-up, but of talk therapy only, then the physician may not meet face-to-face with the patient again, although the physician receives periodic updates from the therapist and remains responsible for the patients treatment. A word about medication visits. It is sometimes objected that it is expensive for the agency to have both the physician and the therapist in the room with the patient during so-called medication checks. We find that it saves time and money in the long run. The therapist is able to quickly summarize external events and the patients talk therapy since the last medication visit, precluding the need for the patient to remember and to narrate everything twice. Importantly, the therapist knows the patient better than the psychiatrist, and is therefore sensitive to tell-tale problems that the patient may not notice or may not report to the doctor. The medication check provides the patient, the therapist, and the psychiatrist an opportunity to revise the treatment plan. Once the patient has left the room, the meeting provides the team with an opportunity for informal teaching and mentoring. Learning can go both ways, insofar as therapists with special skills can inform psychiatrists about these techniques. It is quite commonplace for family members related to the index patient to seek treatment also, or to seek treatment elsewhere. In our experience, it works best if members of the family are seen by the same team for evaluation and for treatment. Except in special circumstances, such as an established individual talk therapy along psychodynamic lines, the policy of one therapist per family generally avoids clinical stalemates associated with split treatments. The team model makes it possible to collect families with fragmented care into one coordinated plan. At intake, the team explains Look, we dont do split treatments because they arent effective. We recommend that you suspend these other therapies and bring everything here and see how that goes. Involvement of family members in support of the treatment from the outset, as part of the evaluation and development of the treatment plan, allows for identification of issues, sometimes psychiatric diagnoses, and sources of distress and of strength within the family. The therapist asks the pro-active question, Who else might be impacted by the patients condition? with special emphasis on women and children as particularly vulnerable. Outreach to family members who are often both part of the problem and part of the solution leads to improved outcomes for everyone. A single psychiatrist develops the treatment plan for the entire family, in conjunction with all family members and with the therapist or therapists as needed.

7 From the patients perspective however, the functioning of the treatment team does not appear to follow a medical model. The patients relationship is with the therapist primarily, and the therapist has the power to summon the physician at the appropriate moments as needed. From the patients point of view, the physician is something the therapist pulls out of his or her pocket at the right time. The team establishes from the patients point of view the containing presence of one primary personal relationshipwith the therapist member of the teamwho follows the patient across different levels of care, across referrals, and thus counteracts the fragmentation of care that has been the major source of problems for us. This primary single personal relationship is valuable because it focuses on the human reality of trust and the meaningfulness of actual personal connections; it is the most respectful, in our view, of the patients right to be acknowledged as an individual. Because the treatment team is the initial patient contact in the agency, the same staff members remain connected to the patient from the outset. This avoids the loss of the human relationship experienced in hand-off referrals where the intake function then passes the chart along to another clinician for treatmenta particularly unconstructive set-up. We have found that the hand-off wastes everyones time and is particularly discouraging to the patient. A Treatment Team is well situated to manage assessment and implementation of intensity-of-care issues: to anticipate when the patient may be at risk for decompensation, to develop out-reach relationships with families, schools, and with other involved professionals, and to respond promptly to the need for referrals to day hospital, emergency rooms, or hospital admission offices. The therapist manages these concrete communications with the added clout of the physicians recommendations behind them as the doctors orders. The treatment team, through ongoing communications with the inpatient therapist, is then responsive to discharge issues, maximizing continuity of care. To support the goals of effective treatment teams, the management of the agency has to back up these goals with policy and procedure and to provide an agency infrastructure that promotes effective functioning of the treatment team. This leads us to the second category of reform, based upon, WORTHY PRINCIPLES OF ADMINISTRATIVE PRACTICE Appropriate support from clinic management involves an ongoing assessment and measurement of practical elements such as the timing and flow of work, staffing, documentation, ongoing training, communications, and the measurement of outcomes. We would like to highlight a few of these elements. One very important aspect of agency administration is the way in which policy and procedure are communicated to staffif this is the way things are done here, how would you know? Where is the policy that describes it? Is there a policy and procedure manual, and how are changes in policy developed, communicated to staff members, monitored, and reinforced? One domain of administrative support which is often lacking in outpatient agencies is clear guidelines around crises such as patient dangerousness to self and others. Each agency must provide information to its clinicians about how to assess danger, what to ask, how to document this, whom to notify, and

8 what to do. Clinicians cannot invent these responses on the spotthese steps have to be written, accessible, and practiced. The question of defining who is in treatment?is very important to us, because doctors can be held legally responsible for acts committed by their patients in the United States. Things may be very different in Palestine. All the same, the agency must have clear policy and procedure around missed appointments and follow-up, so that patients who have dropped out of treatment are notified right away by letter: We have not heard from you since your missed appointment on such and such date. Please contact us within seven days, or we will close your case. You are of course welcome to return at any time to re-open your treatment if you wish. The patient is invited to returnyou might say, reminded to returnat the same time informed that the contractual treatment relationship is suspended until the patient does return. Policy and procedure are themselves the subject of ongoing agency study and review. Quality Assurance passes under many names but traditionally refers to the ways in which problems in agency functioning are identified. Often the QA process is not handled well, and clinicians view it as a nuisance or source of unnecessary paperwork or intrusive meddling by critics who dont have any insight into clinical realities. QA is often guilty of these flaws. On the other hand, an imaginative QA process can be an enormous asset in helping track outcomes and identify areas for improvement, including revealing holes in the system and highlighting precisely those issues which clinicians find burdensomereduplication of tasks (especially repetitive paperwork), impediments to the flow of work, and poor communications. QA when properly performed can be a powerful tool for solving problems brought forward by group members as issues to be studied and remedied. A box into which anonymous written complaints can be slipped may be useful, as well as a habit of pulling ten charts and looking for areas in need of improvement, or sending patients or staff anonymous questionnaires, asking How are we doing? It is crucial that the QA process focuses on measuring and improving systems issues and not on punishing particular individuals for errors. The goal of QA is to involve all of the staff in pondering, How can we do this part of the process better? and in participating in brainstorming solutions. This in itself improves group cohesion and group performance. Related to QA are questions of fairness: the dual issues of patient grievance procedure and staff grievance procedure. Patients must have available to them written guidelines for the process of conflict resolution that follows a hierarchy until the issue is resolved satisfactorily. Staff too must have available to them clear and meaningful routes of redress. A community mental health center cannot run well where there is a staff in-group and out-group, favoritism, nepotism, or lack of transparency in hiring. Pay grades and benefits must be related to measurable performance, without injustice involving personal vendettas, gender inequities, or distortions connected to office or community politics. Workers need to be respected for their work and to have faith in their leaderships commitment to fair practices. Community mental health is successful when the workplace is itself a healthy community. The QA process can identify areas where new learning might be valuable. Ongoing staff training and development is crucial for morale so that the staff feels rooted in its sources of professional identity and

9 growth. The team itself, supervision, and case conferences provide opportunities for mentoring and learning across disciplines. Speakers and conferences help make the center a community of ideas. THE PRINCIPLE OF INTEGRATION OF MENTAL HEALTH INTO AN AGENDA FOR PUBLIC HEALTH AND SOCIETY OVERALL Integrating mental health into a broad social agenda is naturally a greater challenge for us because we can control what happens within our own agency to a much larger extent than we can control the public sphere. We can however make some observations about the benefits of integrating mental health into public health, especially as regards prevention and advocacy. We know as psychiatrists that emotional problems are crucial as pervasive untreated mental health disorders within the population at large and that anxiety and depressive disorders alone represent an enormous public health disease burden. We know that psychological issues are crucial as risk factors and as management factors in a host of medical illnesses through lifestyle choices such as cigarettes, diet, and exercise as well as the key issue of treatment adherence. The newest research tells us that the best medical outcomes are associated with integrated treatment plans for medical and mental disorders--for example, the unified treatment of heart disease and depression. Public health initiatives can and should be developed that integrate diagnosis and treatment for both mental health and general medical disorders at the point of service delivery. A clinical agenda that supports mental health as an aspect of public health must be supported by the corresponding administrative agenda. Thus, if we as practitioners within community mental health hope to connect an individual patients mental health to his or her physical health, then medical care policy planning on a local and on a national level must be organized with this goal also. This has immense implications for funding, for policy development, and for infrastructure within an overall medical care system. On the basis of our experiences in the United States, we recommend, as development of the medical care system in Palestine goes forward, that all of you be advocates for the integration of mental health care into general medical care at every level. A medical model of mental health does not mean that everything wrong is a neuron or molecule, or that everything good is a pill. The medical model of mental health means that mental illness is conceptualized as similar in many ways to hypertension or cancer. One benefit of the public health perspective is its capacity to reduce the stigma associated with mental disorders which is so powerful in delaying people from seeking help and in undermining the effectiveness of the help they seek. The stigma associated with mental disorders is both a cause and a consequence of our patients invisibility, poverty, and low social capital. The prejudice against mental disorders afflicts not only patients but also the professionals and programs which treat themwhich are typically underfinanced in comparison to other health programs. This stigma often infiltrates the perception of treatment outcomes, such that mental conditions are seen as especially hopeless and treatment resistant. In fact, the outcome of good management of chronic mental disorders is quite similar to the outcomes measured with cardiovascular disease, arthritis, and other chronic conditions. A

10 public health perspective helps us in our advocacy and outreach by uniting the agenda of mental health with the uncontroversial goals of pediatrics, obstetrics, and internal medicine. To have a seat at the table among other medical specialties, psychiatry must show that it is an effective team player. We in the United States have not always succeeded in communicating with other physicians clearly and helpfully about our mutual patients. And likewise, psychiatry has not always been a good team player with other disciplines: social work, psychology, and nursing. Competition for prestige, turf wars, and the development of completely separated vocabularies, skill sets, and ways of understanding the patient have all stood in the way of partnership, teamwork and coordinated management. We advise you to do better than we have done in working with other professionals at the bedside and in the area of policy planning. One of the most important benefits of the public health perspective is its reminder that the relief of suffering is a fundamental human right. We see mental health as part of social well-being, a strengthbased resilience in a context of healthy relationships, families, communities, societies, and nations. We are aware that current research indicates that genes and environments in isolation from one another have little predictive power. It is instead the interaction between genes and environments that predict clinical syndromes. Through this understanding, our newest thinking about human development has come to stress the integration of the narrowly biological with social realities. Psychiatry, through its gene-environmental model of risk, has many recommendations for prevention that focus on parenting, child development, education, jobs and working conditions, neighborhoods, gender equity, and conflict resolution. But we also view mental health in the context of specific risk factors, and an inventory of risk-factors dangerous to mental health is familiar to all of us: poverty, military occupation, war, and violence in all of its many forms: sexual and physical abuse of children, domestic and community violence. We know that unemployment is a major risk factor for suicide; last year, among American troops involved in our various military operations overseas, suicide was the cause of a larger number of deaths than combat. A community mental health center cannot itself do much single-handedly to undo poverty and war. But a broad public health agenda can take on these risk-factors as points of advocacy and change, viewing social policy as within its domain. Increasingly, global public health sets as its goal as overall human wellbeing dependent upon social justice. Increasingly public health organizations and global leaders through the United Nations are holding governments responsible for health gradients between rich and poor. We must hold every nation responsible for health risks generated by the entire field of its global policy decisions. Psychiatrists have a special role to speak for the silenced in the areas of childrens rights, womens rights, the rights of prisoners, displaced and homeless persons, and victims of war, occupation, neocolonialism, torture, and every form of exploitation. Psychiatry has a special role in the arena of human rights because of its specific understanding of the implications of victimization on child development, on lifelong symptomatology, on the health of our families and communities, and on the capacity for human beings to fulfill their potential. Community mental health is the domain where these large issues of inequality and injustice, issues that involve the whole world, become very concrete and particular.

11 We have known in community mental health in the United States a large number of very wonderful people: patients and staff, many of whom are well aware of the broad and complex sources of human suffering. Something is wrong with our neurons and something is wrong with our entire planet. Community mental health is where these issues come together, which is why we in community mental health feel that our work matters. We in the United States are very glad to share some of our experiences with you here in Palestine, in the hope that you will share your experiences with us. We hope to form a friendship that becomes its own kind of team, as advocates for justice for our patients and justice in the world. RERERENCES 1. Bhutta ZA, Reddy KS. Achieving Equity in Global Health: So Near and Yet So Far. JAMA. 2012;307(19);2035-2036. 2. Commission on Social Determinants of Health. Closing the Gap in a Generation: Health Equity Through Action on the Social Determinants of Health: Final Report. Geneva, Switzerland: World Health Organization; 2008. 3. Marmot MG. Policy Making with Health Equity at Its Heart. JAMA. 2012:307(19);2033-2034