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Improving the Quality of Health Care for Mental and Substance-Use Conditions 4 Strengthening the Evidence Base and Quality Improvement Infrastructure Summary Despite substantial evidence documenting the efficacy of numerous treatments for mental and substance-use problems and illnesses, mental and/or substance-use (M/SU) health care (like all health care) often is not consistent with this evidence base. Further, in the absence of evidence on how best to treat some M/SU conditions, treatment for the same condition often varies inappropriately from provider to provider. Moreover, medication errors and the use of restraints and seclusion threaten patient safety, while many individuals with serious symptoms of M/SU illnesses receive no treatment despite having health insurance and geographic access to health care. Finally, although we know about risk factors for the development of some M/SU illnesses, the health care system fails to apply this knowledge in prevention initiatives. As a result, large numbers of people who are at risk of developing M/SU illnesses go on to do so, even as those with existing illnesses cannot always count on receiving safe and effective care. Remedies for these problems are the same as those for general health care: identifying and disseminating effective practices, providing decision support for clinicians at the point of care delivery, measuring the extent to which effective practices are applied, and incorporating measurement results into ongoing quality improvement activities. For multiple reasons, however, the infrastructure to support these activities is less well developed for M/SU than for general health
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Improving the Quality of Health Care for Mental and Substance-Use Conditions care. Clinical assessment and treatment practices (especially psychosocial interventions) have not been standardized and classified for inclusion in the administrative datasets widely used to analyze variations in care and other quality-related issues in general health care. Initiatives to disseminate advances in evidence-based care often fail to use effective strategies and available resources. The development of performance measures for M/SU health care has not received sufficient attention in the private sector, and efforts in the public sector have not yet achieved widespread consensus. Finally, the understanding and use of modern quality improvement methods have not yet permeated the day-to-day operations of organizations and individual clinicians delivering M/SU services—both those in the general health care sector and those providing specialty M/SU health care. The committee recommends a five-part strategy to build this infrastructure and improve the safety and effectiveness of M/SU health care: (1) a more coordinated strategy for filling the gaps in the evidence base; (2) a stronger, more coordinated, and evidence-based approach to disseminating evidence to clinicians; (3) improved diagnostic and assessment strategies; (4) a stronger infrastructure for measuring and reporting the quality of M/SU health care; and (5) support for quality improvement practices at the locus of health care. PROBLEMS IN THE QUALITY OF CARE As in general health care, there is ample evidence of problems in the quality of care for mental and/or substance-use (M/SU) problems and illnesses. These problems include (1) failure to provide care consistent with existing scientific evidence, (2) variations in care that occur when clear evidence on effective care is lacking, (3) failure to provide any treatment for an M/SU illness or to address the risk factors associated with the development of these illnesses, and (4) unsafe care. Failure to Provide Care Consistent with Scientific Evidence Numerous studies document the discrepancy between M/SU care that is known to be effective and the care that is actually delivered. An extensive review of all peer-reviewed studies published from 1992 through 2000 in Medline, the Cochrane Collaborative, and related sources that assessed rates of adherence to specific clinical practice guidelines for treating diverse M/SU clinical conditions (including alcohol withdrawal, bipolar disorder, depression, panic disorder, psychosis, schizophrenia, and substance abuse)
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Improving the Quality of Health Care for Mental and Substance-Use Conditions found that of the 21 cross-sectional studies showing unequivocal results, only 24 percent documented adequate adherence to the aspect(s) of the practice guidelines under study. Of 5 pre/post studies, only 2 showed adequate adherence rates. When these two groups of naturalistic studies were combined, only 27 percent demonstrated adequate rates of adherence. Better adherence was observed in 6 of the 9 controlled trials reviewed1 (Bauer, 2002). Subsequent studies have continued to document clinicians’ departures from evidence-based practice guidelines for conditions as varied as attention deficit hyperactivity disorder (ADHD) (Rushton et al., 2004), anxiety disorders (Stein et al., 2004), conduct disorders in children (Zima et al., 2005), comorbid mental and substance-use illnesses (Watkins et al., 2001), depression in adults (Simon et al., 2001) and children (Richardson et al., 2004), opioid dependence (D’Aunno and Pollack, 2002), use of illicit drugs (Friedmann et al., 2001), and schizophrenia (Buchanan et al., 2002). As in general health care, M/SU care received by members of racial and ethnic minorities is even less consistent with standards for effective care than that received by nonminority members. Two nationally representative studies found that members of ethnic minorities were less likely to receive appropriate care for depression or anxiety than were white Americans (Wang et al., 2000; Young et al., 2001). Likewise, facilities dispensing methadone for the treatment of opioid dependence that have a greater percentage of African American patients have been shown to be more likely to dispense low and ineffective doses (D’Aunno and Pollack, 2002). A 1999 comparison of the performance of 67.7 percent of the nation’s health maintenance organizations (HMOs) on five measures of the quality of mental health care2 and nine measures3 of the quality of general health care found that the HMOs delivered mental health care in accordance with standards of care on average 48 percent of the time, compared with an average of 69 percent for the nine general health care measures (Druss et al., 2002). In a landmark study of the quality of a wide variety of health care received by U.S. citizens, individuals with many different types of illnesses received guideline-concordant care about 50 percent of the time, whereas those with alcohol dependence received care consistent with scientific knowledge only about 10.5 percent of the time (McGlynn et al., 2003). 1 This was attributed to the multifaceted and intensive strategies employed to facilitate and maintain the uptake of these practice guidelines. 2 Timely ambulatory care after inpatient hospitalization (two measures), medication management of depression (two measures), and outpatient care for depression (one measure). 3 Adolescent immunizations, use of specific drugs after a heart attack, breast cancer screening, child immunizations, delivery of prenatal care in the first trimester, postpartum check-ups, cervical cancer screening, cholesterol screening, and eye examinations for diabetics.
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Improving the Quality of Health Care for Mental and Substance-Use Conditions This failure to provide care consistent with evidence also is manifest in the failure to offer ongoing care for substance dependence consistent with the condition’s chronic nature. Historically, drug dependence has been conceptualized as a disease, a bad habit, or a sin (Musto, 1973). Despite significant differences among these perspectives, all are based on a view that often persists today: that some limited (often very limited) amount, duration, and/or intensity of therapies, medications, and services should be adequate to cause patients with a drug dependence illness to “learn their lesson,” “achieve insight,” and especially “change their ways.” The expectation is that once patients have achieved that insight or learned that lesson, they will be ready for discharge from treatment and will continue as recovered for a substantial period of time. This view has led to the universally applied convention of evaluating the outcomes of treatment through measurement of patient performance 6–12 (or more) months following discharge from treatment (see Finney et al., 1996; Gerstein and Harwood, 1990; Gossop et al., 2001; Hubbard et al., 1989; McLellan et al., 1993a,b; Project MATCH Research Group, 1997; Simpson et al., 1997, 1999). In fact, however, most alcohol- and drug-dependent patients relapse following cessation of treatment (IOM, 1998; McLellan, 2002). In general, about 50–60 percent of patients begin reusing within 6 months of treatment cessation, regardless of the type of discharge, patient characteristics, or the particular substance(s) used (IOM, 1998; McKay et al., 1999, 2004; McLellan, 2002). It is increasingly apparent that patients with more chronic forms of substance-use illnesses require and do well with appropriately tailored continuing care and monitoring (McKay, 2005; McLellan et al., 2000). Indeed, accumulating evidence suggests that many cases of substance-use illness are best treated with the same type and level of ongoing clinical support as other chronic illnesses, such as cardiovascular disease and diabetes (McLellan et al., 2000). Variations in Care Due to a Lack of Evidence Variations in health care are driven by a variety of factors—some appropriate and therapeutic, others not. Appropriate variations in care result when clinicians tailor therapeutic regimens to patients’ unique clinical conditions, in consultation with patients about their expressed preferences and values. Undesirable variations reflect departures from widely accepted evidence-based standards of care (as described above) due to provider preferences, traditions, ignorance of evidence-based standards, or administrative or financial constraints. Variations also result from inconsistencies in diagnosis (described later in this chapter) and from the absence of widely accepted standards of care. Variations in the absence of clinical practice guidelines have been documented, for example, in the use of seclusion and
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Improving the Quality of Health Care for Mental and Substance-Use Conditions restraint (Busch and Shore, 2000), patterns of prescribing psychotropic medications for preschoolers and older children (Rawal et al., 2004; Zito et al., 2000), the use of combinations of antipsychotics (Miller and Craig, 2002), and inpatient care lengths of stay (Harman et al., 2003). A 1999–2000 cross-sectional study of the care of children and adolescents at residential treatment centers in four states, for instance, found that 42.9 percent of youths receiving antipsychotic medications had no history of or current psychosis and were thus receiving those medications for “off-label” purposes. Significant regional differences in the prescription of antipsychotic drugs were found across the four states and were associated with the presence of attention deficit/impulsivity, substance use, the duration of symptoms, danger to others, sexually abusive behavior, elopement, and crime/delinquency. The use of antipsychotic medications to treat aggression and conduct disorders has been reported in the clinical literature and identified as an off-label use. Yet positive outcomes for their use in children to treat attention deficit/impulsivity disorders is not well documented and raises concerns, as does the widespread use of antipsychotics for off-label purposes generally and the regional variations in this practice (Rawal et al., 2004). There is historical evidence that race and ethnicity account for some of these variations. African Americans have been more likely to receive antipsychotics across the diagnostic spectrum, even without indications for their use (Strickland et al., 1991), and more likely than whites to receive these medications “PRN” (as needed) and in higher doses (Chung et al., 1995; Strakowski et al., 1993). Failure to Treat and Prevent Failure to Treat More than a decade ago, the 1990–1992 National Comorbidity Study documented the high proportion of individuals with symptoms of serious mental illness who failed to receive any treatment for their condition (Wang et al., 2002). Since that time, progress has been made. Recent studies have shown improvements in access to and receipt of care for those with the most severe mental illnesses (Kessler et al., 2005; Mechanic and Bilder, 2004). And although the prevalence of M/SU illnesses has remained the same over the past decade, a greater proportion of all non-aged adults with M/SU problems and illnesses have received treatment. Between 1990 and 1992, 20.3 percent of individuals with a mental “disorder” received treatment; between 2001 and 2003 this proportion was 32.9 percent (Kessler et al., 2005). Improvements also have been noted in the access to care for children with these illnesses (Glied and Cuellar, 2003).
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Improving the Quality of Health Care for Mental and Substance-Use Conditions Despite this progress, however, the same reports showing improved access to care for some reveal that many others who need treatment still do not receive it (Mechanic and Bilder, 2004); this is true especially for ethnic minorities (Kessler et al., 2005). Between 2001 and 2003, fewer than half (40.5 percent) of individuals with symptoms of a serious mental illness received treatment (Kessler et al., 2005), and there is evidence of a decline in access for those with less severe mental illnesses (Kessler et al., 2005; Mechanic and Bilder, 2004). Findings of recent studies similarly reaffirm the continuing failure to treat substance-use problems and illnesses (Watkins et al., 2001). These failures to treat persist, even when individuals are receiving some type of health care and have financial and geographic access to care. For example, data for 1998–2001 from a seven-site longitudinal study of 1,088 youths in residential, outpatient, and inpatient treatment for drug use show that 43 percent of the youths reported receiving no mental health services in the 3 months after being admitted, despite having severe mental health problems at the time of admission. At three sites where mental health services were provided at no additional charge, rates of service receipt for those with severe mental illnesses were 6 percent, 28 percent, and 79 percent, respectively. In contrast, rates of receipt of care for comorbid general health problems among these youths ranged from 64 to 71 percent (Jaycox et al., 2003). Results of the 2003 National Survey on Drug Use and Health document a similar failure to treat adults. Data from another national survey conducted in 1997–1998 reveal that among persons with probable comorbid mental and substance-use disorders who received treatment for one of these conditions, fewer than a third (28.6 percent) received treatment for the other (Watkins et al., 2001). Reasons for the failure to treat M/SU illnesses have not been fully determined, but the finding of low treatment rates in the presence of access to services and no additional cost to the patient indicates that access and ability to pay are not always the only contributing factors. This point is confirmed by responses of civilian, noninstitutionalized adults aged 18 and older to the 2003 National Survey on Drug Use and Health, which captured separately information on mental and substance-use problems and illnesses. These respondents reported the following reasons for not receiving mental health treatment that they believe they needed: cost/insurance issues (45.1 percent), did not feel the need for treatment at the time/could handle the problem without treatment (40.6 percent), did not know where to go for services (22.9 percent), stigma (22.8 percent), did not have time (18.1 percent), believed treatment would not help (10.3 percent), fear of being committed/having to take medication (7.2 percent), and other access barriers (3.7 percent). Reasons given by respondents who felt they needed treatment for a substance-use problem but did not receive it were somewhat
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Improving the Quality of Health Care for Mental and Substance-Use Conditions different: not ready to stop using (41.2 percent), cost or insurance barriers (33.2 percent), stigma (19.6 percent), did not feel the need for treatment (at the time) or could handle the problem without treatment (17.2 percent), access barriers other than cost (12.3 percent), did not know where to go for treatment (8.7 percent), believed treatment would not help (6.3 percent), and did not have time (5.3 percent) (SAMHSA, 2004a). Other studies of factors that influence consumers’ entry into alcohol and drug treatment have found that individuals with alcohol or drug problems who do not experience recovery on their own typically do not go into treatment until their problems become severe or until social circumstances, such as workplace problems or criminal offenses, send them there. In a 2001 nationally representative survey of individuals in recovery from alcohol or drug illnesses and their families, 60 percent reported that denial of addiction or refusal to admit the severity of the problem was the greatest barrier to their recovery. Embarrassment or shame was the second most frequently cited obstacle (Peter D. Hart Research Associates, Inc., 2001). Factors that drive these individuals to seek help vary over the course of their alcohol or drug use. Early on, these factors include adverse social consequences in the workplace, criminal convictions, or serious disturbances in interpersonal relationships. As substance use progresses over time, health problems related to use are associated with seeking treatment (Satre et al., 2004; Weisner and Matzger, 2002). Individuals who are members of ethnic minorities face additional obstacles to receiving needed mental health services (DHHS, 2001). Despite roughly similar levels of need, ethnic minorities are less likely to receive mental health care than are white Americans. Blacks, for example, are only 50 percent as likely to receive psychiatric treatment as whites when both receive a diagnosis of the same severity (Kessler et al., 2005). Latino children also have higher rates of unmet need relative to other children (Kataoka et al., 2002). Access to mental health services may be restricted for ethnic minorities for multiple reasons—for example, because they are more apt to be uninsured (Brown et al., 2000), because ethnic minority providers and/or providers with appropriate language capabilities are often unavailable, and because they may have less trust in the health care system (LaVeist et al., 2000). Failure to Prevent Sometimes failure to provide care occurs at the level of the health system, rather than at the patient–provider level. The United States, like other developed countries, has structures and mechanisms in place to address threats to the public’s health that arise from both external environmental conditions and an individual’s personal health practices. An earlier
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Improving the Quality of Health Care for Mental and Substance-Use Conditions Institute of Medicine report on reducing risks for mental disorders (IOM, 1994) notes that prevention activities for many general health conditions take place even when the etiology of an illness and how to prevent it are not fully understood. Examples are primary prevention of cancer and heart disease, for which the public health system has targeted known risk factors (e.g., diet, exercise, lipid levels, smoking) despite the lack of such knowledge. This risk reduction model of prevention targets the risk factors known to be associated with an illness or injury. By contrast, despite scientific evidence on risk factors associated with some mental illnesses (predominantly in children and adolescents) and effective interventions to mitigate these factors (see, e.g., Beardslee et al., 2003; Hollon et al., 2002; Mojtabai et al., 2003), this evidence has not yet been widely applied in practice (Davis, 2002), and the prevalence4 of M/SU problems and illnesses does not appear to have declined over the past decade (Kessler et al., 2005). Although there is not yet clear evidence to support preventive interventions for specific diagnoses (e.g., ADHD, anxiety, or depression), risk factors have been identified that have been helpful for developing broad, school-based preventive programs that generally target “behavior problems.” This prevention literature for children is focused largely in two areas: (1) risk factors for conduct problems, serious disruptive behaviors, and violence, and testing of interventions aimed at preventing the onset of those problems (Kazdin, 2003; Patterson et al., 1989, 1993; Webster-Stratton and Hammond, 1997, 1999); and (2) prevention of depression among adolescents (Clarke et al., 1995; Lewinsohn, 1987) or children (Beardslee et al., 1996, 1997; Podorefsky et al., 2001). The U.S. Surgeon General’s report on youth violence also clearly sets forth the evidence for prevention of violent behavior (Office of the Surgeon General, 2001). Unsafe Care As with the quality of M/SU health care overall, less is known about errors in or injuries due to M/SU treatment services than is the case for general health care (Bates et al., 2003; Moos, 2005). This is especially true for errors that occur in outpatient settings, where the greatest proportion of treatment for individuals with M/SU problems and illnesses is provided. Some mental health “interventions” have been found to be harmful subsequent to their use; examples are organized visits to jails and prisons by children or adolescents to deter their future delinquency (sometimes known as “scared straight” programs) (Petrosino et al., 2005) and rebirthing therapy (Lilienfeld et al., 2003). Others, such as critical incidence stress 4 Data on incidence are not available.
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Improving the Quality of Health Care for Mental and Substance-Use Conditions debriefing, have been found to be potentially harmful (Rose et al., 2005). Most data on threats to safety have been collected on medication errors and the use of seclusion and restraints in mental health care. Errors or injuries from treatment for substance-use problems and illnesses have not yet received substantial attention. Although an estimated 7–15 percent of patients who receive psychosocial treatment for substance use may be worse off after treatment, a conceptual model to help distinguish the iatrogenic effects of the intervention from other factors that can cause worsening of substance-use problems (e.g., social isolation) has only recently been proposed (Moos, 2005). Medication Errors A Medline search for articles published between 1996 and 2003 on medication errors (one of the most common types of health care errors) in psychiatric treatment revealed relatively few data available, and only a handful of studies of adverse drug events in inpatient psychiatric settings. Although studies of adverse drug events in general hospitals have yielded data on errors involving psychotropic drugs, less is known about medication errors in psychiatric hospitals and psychiatric units of general hospitals. Moreover, as recently as 2002, terms such as “adverse drug events,” “medication errors,” and “adverse drug reactions” were not even listed as key search words in several widely read psychiatric journals (Grasso et al., 2003b). Errors committed in substance-use treatment also have received little attention. What is known from the few published studies gives cause for concern. A retrospective, multidisciplinary review of the charts of 31 randomly selected patients in a state psychiatric hospital discharged during a 4 1/2-month study period detected 2,194 medication errors during these patients’ entire 1,448 inpatient days.5 Of the 2,194 errors, 19 percent were rated as having the potential to cause minor harm, 23 percent moderate harm, and 58 percent severe harm (Grasso et al., 2003a). Another 12-month study of all long-term residents of 18 community-based nursing homes in Massachusetts found that psychoactive medications (antipsychotics, antidepressants, and sedatives/hypnotics) were among the most common medications 5 These medication error rates are consistent with rates reported in studies occurring in general medical hospitals, but the distribution of the types of errors is markedly different. A much higher proportion of errors (66 percent) occurred during the administration of the medication as opposed to its prescribing, transcription, or dispensing. The authors note that at the time the study was conducted, medication administration was performed by medical technicians as opposed to licensed nurses—a practice that was discontinued subsequent to the study (Grasso et al., 2003a).
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Improving the Quality of Health Care for Mental and Substance-Use Conditions associated with preventable adverse drug events, and neuropsychiatric events were the most common type of preventable adverse drug events (Gurwitz et al., 2000). With respect to ambulatory care, additional safety concerns have been raised about the practice of long-term treatment with combinations of antipsychotic medications (except in instances of failures of monotherapy using different drugs). The use of combinations of antipsychotic medications continues despite (1) the absence of evidence to support the practice, (2) the lack of evidence to inform clinicians about how to adjust dosages in the face of increased symptoms or side effects, and (3) increased risks to the patient from problematic side effects and failure to adhere to treatment (Miller and Craig, 2002). Similarly, experts in children’s mental health care express concern about the growing use of atypical antipsychotics to treat aggression in children and adolescents in the face of limited basic and clinical research supporting the rationale, efficacy, and safety of using these agents for this purpose (Patel et al., 2005). Seclusion and Restraint Use of seclusion and restraint, while necessary in some emergency situations to prevent harm to a patient or others, also is associated with substantial psychological and physical harm to patients (GAO, 1999). The federal government estimates that each year approximately 150 individuals in the United States die as the direct result of these practices (SAMHSA, 2004b). In 1998, the death of an 11-year-old boy who died while secluded and restrained in a psychiatric hospital focused national attention on the risks to patients when these approaches are used. A follow-up report of the U.S. General Accounting Office (now the Government Accountability Office) (GAO) confirmed the danger of improper use of seclusion and restraint and called attention to inadequate monitoring and reporting of their use, inconsistent and insufficient standards for their use and reporting by licensing and accreditation bodies, and widespread failure to employ strategies that can prevent their use and reduce the risk of related injuries. Children experience higher rates of seclusion and restraint relative to adults and are at greater risk of injury from their use (GAO, 1999). Consumers and their advocates, professional associations, provider organizations, and the federal government recommend substantial reductions in the use of seclusion and restraint (American Association of Community Psychiatrists, 2003; NAMI, 2003; NASMHPD, 1999, 2005; SAMHSA, 2004b). GAO found that these practices can be greatly reduced through strong management commitment and leadership, defined principles and policies regarding when and how they may be used, a requirement to report their use, staff training in their safe use and alternative approaches, and
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Improving the Quality of Health Care for Mental and Substance-Use Conditions oversight and monitoring (GAO, 1999).6 Several initiatives incorporating these practices have greatly reduced the use of seclusion and restraint (American Psychiatric Association et al., 2003; Hennessy, 2002), some achieving near elimination of the practices. Pennsylvania’s state psychiatric hospital system, for example, which called attention to the use of seclusion and restraints as an indicator of “treatment failure,” sharply decreased their use from 107.9 hours per 1,000 patient days in 1993 to 2.72 hours per 1,000 patient days in 2000 through quality improvement initiatives in all state psychiatric hospitals (Smith et al., 2005). Use of seclusion and restraint continues, however, despite a Cochrane Collaboration finding that “few other forms of treatment which are applied to patients with various psychiatric diagnoses are so lacking in basic information about their proper use and efficacy (Sailas and Fenton, 2005:4). As a result, seclusion and restraints are frequently applied without clear indications for their use (Finke, 2001) and can lead to death (Denogean, 2003; Schnaars, 2003), physical harm (Mohr et al., 2003), or severe psychological trauma (Pflueger, 2002).7 Individuals admitted to inpatient psychiatric care often have a history of sexual or other physical abuse (Goodman et al., 1997; Mueser et al., 2002). Being physically overpowered, restrained, or placed in a locked room may have many features in common with the abuse experienced earlier by these individuals. Heightened Safety Concerns and Need for Multiple Actions The limited information on the safety of M/SU health care is of particular concern because some of the unique features of M/SU illnesses and their treatments could make patients less able to detect and avoid errors and more vulnerable to errors and adverse events when they occur. For example, the stigma experienced by individuals with M/SU illnesses may make them less willing to report errors and adverse events and less likely to be believed when they do so. The symptoms of some severe illnesses, such as major depression or schizophrenia, when not alleviated by therapy, also could interfere with a patient’s ability to detect and report medication errors. The departures from scientific knowledge, variations in care, failures to treat and prevent, and unsafe practices discussed above have multiple causes. These include (1) gaps in the evidence base, (2) problems in disseminating existing evidence to clinicians and ensuring its uptake, (3) greater subjectiv- 6 These initiatives are intended to complement other essential elements, such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments. 7 Because reporting of the use of seclusion and restraints is not required, however, data on prevalence rates for their use and rates of adverse consequences are not available.
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