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National Guideline Alliance (UK). Mental Health Problems in People with Learning Disabilities: Prevention, Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Sep. (NICE Guideline, No. 54.)
Following significant concerns that psychotropic drugs in general, and antipsychotics in particular, are used inappropriately in people with learning disabilities (Brylewski & Duggan, 2004; Matson et al., 2000; Molyneux et al., 1999; Sheehan et al., 2015; Tsiouris, 2010), there has been a concerted effort to improve clinical practice in this area (Slowie & Ridge, 2015). It is important to note, as these references indicate, that these concerns have been driven by the prescription of antipsychotic drugs for people with learning disabilities who have challenging behaviour, rather than mental illness.
Broadly speaking, people with learning disabilities are prescribed psychotropic drugs including antipsychotics in 3 sets of circumstances: either because they have a psychiatric diagnosis, because they have behaviour that challenges or both (NICE, 2015).
A significant proportion of people with learning disabilities display behaviour that challenges. Challenging behaviour is defined as behaviour of an intensity, frequency, or duration that threatens the physical safety of the person or others, or restricts access to community facilities (Emerson et al., 2001). It is a socially constructed, descriptive concept that has no diagnostic significance and makes no inferences about the aetiology of the behaviour. It covers a heterogeneous group of behavioural phenomena across different groups of people, for example oppositional behaviour in children, faecal smearing in those with a severe learning disabilities, and self-harm in adult mental illness. Challenging behaviour may be unrelated to psychiatric disorder, but can also be a primary or secondary manifestation of it (Xeniditis et al., 2001). Likewise it can be related to physical health problems, communication difficulties or environmental changes and in many cases a combination of all of these. A number of authors have devised guidelines around the use of psychotropic medication for those with this condition (Bhaumik et al., 2015; Deb et al., 2006; Deb et al., 2009; Faculty of Psychiatry of Intellectual Disability, 2016; Kalachnik et al., 1998; NICE, 2015; Rush et al., 2000) and NICE offers the most comprehensive guidance to date on this topic (NICE, 2015).
The above definition of challenging behaviour is broad enough to cover acts of aggression towards people, aggression to property, self-neglect, self-harm and the risk of exploitation. It therefore appears that almost anyone who has a mental health problem that reaches the threshold to need attention from primary or secondary care services would have some form of behaviour that challenges as a presenting feature (Faculty of Psychiatry of Intellectual Disability, 2016).
People with learning disabilities develop mental health problems at rates similar to or higher than the general population (see Chapter 4), but failure of staff to recognise it, communication needs and health literacy, atypical presentations, diagnostic overshadowing, and difficulties in accessing services might mean that this is under-recorded (Sheehan et al., 2015) and underdiagnosed. This can be particularly problematic in those patients who are unable to give a clear verbal account of their mental health problems or ask for help. When mental health problems are accompanied by aggression and/or destructiveness, the latter can be a trigger for seeking help. Even in those who do have expressive speech, many find it difficult to describe precisely their mental health problems. Thus in clinical practice, a psychiatric diagnosis may be recorded only when the main syndromes are present (for example, schizophrenia or bipolar disorder), while the narrative account of mental health problems (for example, transient psychotic symptoms and affective lability in someone with milder learning disabilities and a personality disorder) is left out (Faculty of Psychiatry of Intellectual Disability, 2016). This may contribute to under-recording of psychiatric diagnoses and in adequate monitoring of prescriptions.
Current best practice would suggest (Bhaumik et al., 2015; Deb et al., 2006; Deb et al., 2009; Rush et al., 2000) that the most important part of psychotropic medication prescribing for this group is the need for a clear assessment before the prescribing followed by regular review and monitoring of the prescribing.
That assessment should include a full recording of all the diagnoses and a clear identification of the psychotic, affective and behavioural symptoms including clusters of symptoms (Bhaumik et al., 2015) that are the target of treatment. Clinicians should bear in mind the possibility of atypical presentations and modifications of typical symptoms due to concurrent medication use for other indications. There should be evidence of sufficient explanation to patients and/or their families and carers and a record of the patient’s consent and capacity or of any best interest decisions, time frames for reviews and the tapering off or stopping of medication that is ineffective. This is particularly so when the prescribing may be off-license.
The issues of whether the dosages required for treating psychiatric conditions in people with learning disabilities are the same as for the general population, and whether they have more side effects, have been examined. The evidence is not very clear, but the current consensus is that the drugs are equally effective and there is no conclusive evidence of them having more side-effects (Faculty of Psychiatry of Intellectual Disability, 2016).
The high rates of dementia incurred by people with Down’s syndrome highlight the need for special focus on this group. Results from studies with the general population on the use of drugs to delay the decline in dementia may be extrapolated to provide evidence likely to be relevant for people with learning disabilities. Conversely, people with Down’s syndrome are physiologically different to the general population, due to the genetic material coded on chromosome 21, and so stratified and precision pharmacological approaches are indicated.
The review protocol summary, including the review question and the eligibility criteria used for this section of the guideline, can be found in Table 60 and Table 61. A complete list of review questions and review protocols can be found in Appendix F; further information about the search strategy can be found in Appendix H.
Clinical review protocol summary for the review on the prevention of mental health problems.
Clinical review protocol summary for the review on the treatment and management of mental health problems.
As a result of the very limited RCT evidence (see section 6.2.2 below), and in view of considerable risk of bias in lower level evidence of drug studies, the GC considered it inappropriate to go down the evidence hierarchy for pharmacological interventions. The GC, therefore, decided to develop a set of general principles to inform the delivery of pharmacological treatments for people with a mental health problem and learning disabilities. They developed these recommendations using the modified nominal group technique. The method of the nominal group technique used in this guideline is described in the methods section in Chapter 3.
Key issues related to the use of drugs for the treatment of mental problems in people with learning disabilities and a mental health problem were identified from the Frith (Bhaumik et al., 2015) and Maudsley (Taylor, 2012) prescribing guidelines, and from discussions during the GC meetings. These were used to generate nominal statements to be rated by the GC, which were distributed in the form of a questionnaire. The nominal statements were developed to cover a range of areas that had been identified as important by the GC, including deciding upon and obtaining consent for treatment, choice of drugs for particular disorders, dose regimens, drug interactions and side-effects, the impact on comorbid mental and physical disorders, monitoring and adherence, and communication between professionals of different disciplines. An example of a statement that was rated highly by the committee is ‘Before prescribing a drug to treat a mental health problem in people with learning disabilities, clinicians should ensure that they liaise with any other involved specialists (such as neurologists for epilepsy care) to discuss existing drug regimens and possible interactions’.
The questionnaires were completed by all members of the GC. Percentage consensus values were calculated, and comments collated, for each statement. The rankings and comments were then presented to the GC members, and used to inform a discussion of the issues raised by members’ comments. A second round of ratings was not deemed necessary as it was agreed by the GC that all important issues raised in the GC comments could be addressed in the wording of recommendations. A brief summary of the outcome from this process is depicted in Table 62 below; the complete list of statements and ratings can be found in Appendix U and blank copies of the questionnaires used can be found in Appendix T.
Summary of nominal group technique process followed for the development of recommendations on pharmacological interventions for mental health problems in people with learning disabilities.
Very few RCTs were found on pharmacological interventions for the prevention or treatment and management of mental health problems. The existing RCTs were limited to children and adolescents and covered only 2 mental health problems: the treatment of ADHD and the prevention or treatment of dementia in young adults or adults with Down’s syndrome.
There was 1 RCT (N=21) which met the eligibility criteria for this review: Alexandris and Lundell (1968).
An overview of the trial included can be found in Table 63. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of amphetamine versus placebo for ADHD in children with learning disabilities.
The actual between group outcomes with variance were not reported so the results are narratively summarised below. Summary of findings can be found in Table 64. The full GRADE evidence profiles can be found in Appendix N.
Summary of findings table for the analysis of amphetamine versus placebo for ADHD in children with learning disabilities.
The study reported results on a 14-item patient evaluation form completed by nurses, teachers, physicians and the principal investigator after treatment. The 14 items included hyperkinesis, concentration, attention, aggressiveness, sociability, interpersonal relationship, comprehension, mood, work interest, work capacity, reading, spelling, arithmetic and class standing. Each scale was rated on a 5-point rating scale (lower scores being worse). The differences between most subscales were reported as not significant; however, the study reported that comprehension and work interest were significantly better in the amphetamine group than the placebo group (p < 0.05).
The study also reported that there were no significant side effects in either group during the study.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
There was 1 RCT (N=122) which met the eligibility criteria for this review: Simonoff et al. (2013).
An overview of the trial included can be found in Table 65. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of methylphenidate versus placebo for ADHD in children and young people with learning disabilities.
Summary of findings can be found in Table 66. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of methylphenidate versus placebo for ADHD in children and young people with learning disabilities.
The paper combined the results of all degrees of learning disabilities so it was not possible to examine the results by different levels of learning disabilities. However, the study performed an analysis of moderators of treatment response which included degrees of learning disabilities and found no significant effect of degree on the results.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
There was 1 crossover controlled before and after study (N=16) which met eligibility criteria for this review: Christensen (1975).
An overview of the trial can be found in Table 67. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials assessing the use of methylphenidate plus behavioural modification versus placebo plus behavioural modification for symptoms of hyperactivity and inattention in children and young people with learning disabilities.
Summary of findings can be found in Table 68.
Summary of findings table for the analysis of methylphenidate plus behavioural modification versus placebo plus behavioural modification for symptoms of hyperactivity and inattention in children and young people with learning disabilities.
As the correct outcomes from the study required for analysis in Revman were not reported, the results are summarised narratively here.
This paper examined the effectiveness of 2 types of interventions, behavioural modification and pharmacological treatment, upon the inattention and hyperactivity levels of children with varying degrees of learning disability within an educational institution. The authors employed a crossover within-subjects design, where each child acted as their own control. Behaviour was measured using Connors’ Teacher Report Form, classroom observations and measures of child movement in their seat. They found a weak effect of methylphenidate treatment, but only whilst the behavioural modification program was in place. They concluded that behavioural modification was an effective intervention (with significant effects) for symptoms of hyperactivity and inattention, but that methylphenidate was not effective in this population.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
There was 1 crossover RCT (N=10) which met the eligibility criteria for this review: Agarwal et al. (2001).
An overview of the trial included can be found in Table 69. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of clonidine versus placebo for ADHD in children and young people with learning disabilities.
Summary of findings can be found in Table 70. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of clonidine versus placebo for ADHD in children and young people with learning disabilities.
The paper combined the results of all degrees of learning disabilities so it was not possible to examine the results by different degrees.
The study reported that there were some reports of drowsiness with clonidine but did not report if any drowsiness occurred in the control group.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
There was 1 RCT (N=46) which met the eligibility criteria for this review:Correia Filho et al. (2005).
An overview of the trial included can be found in Table 71. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of risperidone versus methylphenidate for ADHD in children and young people with learning disabilities.
Summary of findings can be found in Table 72. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of risperidone versus methylphenidate for ADHD in children and young people with learning disabilities.
The between group values on some measures were not reported in the study so these are summarised narratively here. The study reported the effect of medication on ADHD symptoms on 2 scales which were completed by an independent psychiatrist based on parental reports: SNAP-IV, a revision of the SNAP questionnaire, which includes a total score and scores on 3 subscales, inattentive, hyperactive/impulsive, oppositional subscales; and the hyperactivity subscale of the Nisonger Child Behavior Rating Form (NCBRF). The paper reported that there was a significant effect for time and group assignment on SNAP-IV total scores, a non-significant trend for hyperactivity subscales but no significant effects for inattentive and oppositional defiance disorder subscales. The paper reports no significant difference between change scores on the NCBRF. The author was contacted for more information but this was not received.
The study also reported a mean reduction of 0.53 kg in the methylphenidate group compared with a weight increase of 1.01 kg in the risperidone group and that this was significant.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
A Cochrane review (Livingstone & Macdonald, 2015) which reviewed the evidence on pharmacological treatments in people with Down’s syndrome was adopted for use by this guideline, with permission from the publishers, John Wiley and Sons, and with assistance from the Cochrane Developmental, Psychosocial and Learning Problems Cochrane Review Group (Joanne Wilson, email communication, September 2015; and Nuala Livingstone, email communication, October 2015). Relevant data from this review was considered and analysed according to the strategy set out in the guideline review protocol. Some changes were made for the purposes of this review which included the separation of studies on prevention and treatment and the subgrouping of adverse effects by severity of the side effects.
No trials were found on people with learning disabilities who did not have Down’s syndrome.
There were 2 RCTs (N=142) which met the eligibility criteria for this review: Johnson et al. (2003) and Kishnani et al. (2009).
An overview of the trials included can be found in Table 73. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of donepezil versus placebo for prevention of dementia in adults with Down’s syndrome.
Summary of findings can be found in Table 74. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of donepezil versus placebo for prevention of dementia in people with Down’s syndrome.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
There were 2 RCTs (N=52) which met the eligibility criteria for this review: Kondoh et al. (2011) and Prasher et al. (2002).
An overview of the trials included can be found in Table 75. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of donepezil versus placebo for treatment of dementia in adults with Down’s syndrome.
Summary of findings can be found in Table 76. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of donepezil versus placebo for treatment of dementia in adults with Down’s syndrome.
No data were available for the critical outcome community participation and meaningful occupation.
There were 2 RCTs (N=213) which met the eligibility criteria for this review: Boada (2012) and Hanney et al. (2012)
An overview of the trials included can be found in Table 77. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of memantine versus placebo for prevention or treatment of dementia in adults with Down’s syndrome.
Summary of findings can be found in Table 78. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of memantine versus placebo for prevention or treatment of dementia in adults with Down’s syndrome.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
Unpublished data from 1 RCT (N=21) which was included in the Cochrane review met the eligibility criteria for this review: Cooper 2012 (unpublished; personal communication to R. McShane 12 March 2015).
An overview of the trial included can be found in Table 79. Further information about both included and excluded studies can be found in Appendix L.
Study information table for trials included in the analysis of simvastatin versus placebo for prevention of dementia in adults with Down’s syndrome.
Summary of findings can be found in Table 80. The full GRADE evidence profiles and associated forest plots can be found in Appendices N and O.
Summary of findings table for the analysis of simvastatin versus placebo for prevention of dementia in adults with Down’s syndrome.
No data were available for the critical outcomes of quality of life or community participation and meaningful occupation.
No studies assessing the cost effectiveness of pharmacological interventions aimed at prevention, treatment or management of mental health problems in people with learning disabilities were identified by the systematic search of the economic literature undertaken for this guideline. Details on the methods used for the systematic search of the economic literature are described in Chapter 3.
The GC endorsed statements stating that clinicians should consider:
They did not support the need for additional cardiovascular investigations, above those required for the general population, to be undertaken prior to commencing pharmacotherapy, or for the general adoption of the principle of starting at a low dosage or increasing dosage very gradually
When seeking consent for pharmacotherapy the GC endorsed statements stating that it is important to:
The GC endorsed statements stating that:
The GC endorsed statements stating that:
The GC endorsed statements stating that:
No evidence on the cost effectiveness of pharmacological interventions aimed at preventing, treating or managing mental health problems in people with learning disabilities is available.
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The GC discussed the importance and relevance of various outcomes in the evidence when assessing the effectiveness of interventions at preventing or treating mental health problems in people with learning disabilities. In addition to the effect on the mental health problem which was the aim of the intervention (for dementia, this was cognitive function as well as psychopathology), the GC were of the view that quality of life, and community participation and meaningful occupation were particularly critical outcomes which they agreed to consider in the literature. The GC noted in particular the difficulties with measuring self-reported outcomes in this population, given communication needs and cognitive impairments so there should be caution in the interpretation of these outcomes from the trials. Reported outcomes from multiple sources may be helpful (for example, teachers or parents) in addressing this issue. Additionally, the GC noted the particular difficulty in determining if mental health problems are being effectively treated in people with learning disabilities. Additional important outcomes included problem behaviours, adaptive functioning such as communication skills, service user or carer satisfaction or experience of care, carer health and quality of life, adverse effects of interventions, rates of placement breakdown (including out-of-area placements or rates of restrictive interventions), psychiatric hospital admissions (including length of stay or other outcomes related to admission), as well as offending or re-offending. The GC noted that adaptive behaviour may only be sensitive to treatment effects over a longer period of time. |
| Trade-off between clinical benefits and harms | The GC noted, overall, that there were very few studies on pharmacological interventions for people with learning disabilities and mental health problems that met the criteria to be included in the review and noted the small size of the few studies which were identified. Studies were only identified for 2 mental health problems: treatment for ADHD in children and young people and treatment and prevention of dementia. All the studies on dementia were on populations with Down’s syndrome and did not address the use of these drugs in other learning disabilities populations. Most studies either did not report the degree of learning disabilities of the participants or included mixed populations so it was not possible to draw any conclusions about differential safety or effectiveness on this basis. Also, of those studies included, there was a lack of evidence on the critical outcomes of community participation and meaningful occupation and quality of life in this area. Treatment of ADHD There were 4 studies included for 4 different pairwise comparisons:
The GC agreed that the results from the limited studies were generally consistent with the ADHD guideline recommendations and there was no evidence which they examined to suggest that there should be different recommendations for pharmacological management of children and young people with learning disabilities than from the general population. However, they were particularly concerned about potential issues with polypharmacy and side effects. Treatment and prevention of dementia The evidence covers 3 drugs and is focused on people with Down’s syndrome.
Treatment and prevention of other mental health problems in people with learning disabilities No evidence was found on the use of pharmacological interventions for the treatment and prevention of other mental health problems in people with learning disabilities. |
| Trade-off between net health benefits and resource use | The GC considered the economic consequences arising from the presence of mental health problems in people with learning disabilities that is associated with consumption of extra healthcare resources. The GC also considered the impact of mental health problems on the HRQoL of people with learning disabilities, their families and carers and concluded that provision of effective pharmacological interventions for the prevention and management of mental health problems is likely to improve the HRQoL of service users and their families and carers and reduce healthcare costs resulting from the management of mental health problems in more resource-intensive settings, such as secondary care. The GC estimated that people with learning disabilities receiving pharmacological treatment for a mental health problem may not be able to fully estimate and communicate to staff involved in their care the presence, magnitude and severity of side effects of medication. The GC considered that people with learning disabilities receiving pharmacological treatment for a mental health problem would benefit from closer monitoring of their adherence to treatment, side effects and potential polypharmacy. The GC expressed the opinion that, for safety reasons, children and young people with any learning disabilities and adults with more severe learning disabilities should start medication for a mental health problem only in the care of specialists with expertise in treating mental health problems. The GC also expressed the view that people with learning disabilities taking antipsychotics might benefit from a referral to a psychiatrist with experience in the care of people with learning disabilities and mental health problems, as this would lead to more appropriate monitoring. The GC concluded that additional monitoring and specialist involvement, where needed, would ensure that service users received adequate and effective pharmacological treatment with an optimal benefit to harm ratio and that potential side effects were identified and managed appropriately. The GC acknowledged that provision of pharmacological interventions to people with learning disabilities may be more resource-intensive compared with provision of pharmacological interventions in populations without learning disabilities, and this may have implications for the cost effectiveness of such interventions, but considered that additional medication monitoring and support, specialist involvement and further adaptations in the pharmacological treatment of people with learning disabilities are essential in order to achieve a positive outcome in this population. The GC also considered issues relating to equality, and judged that pharmacological interventions for the prevention and/or management of mental health problems that have been shown to be cost effective in populations without learning disabilities should also be offered to people with learning disabilities, following necessary adaptations and additional monitoring and specialist support. |
| Quality of evidence | The overall quality of the evidence for the treatment of ADHD was low or very low for most outcomes, apart from all outcomes from the comparisons of methylphenidate with placebo which was moderate quality. The overall quality of the evidence for the prevention and treatment of dementia ranged from moderate to very low quality. Imprecision was the main reasons for downgrading a number of outcomes and this was largely due to the very small size of the trials (many of which were pilot studies), as was the risk of bias. The GC noted, in particular, that:
|
| Other considerations | Treatment of ADHD The GC noted that clonidine is not currently licensed for the treatment of ADHD and, as such, is not currently recommended as first-line treatment in the ADHD NICE guideline. However, the ADHD guideline did recommend considering the use of clonidine or other treatments in tertiary services if ADHD is unresponsive to methylphenidate, atomoxetine or dexamfetamine. Treatment and prevention of dementia The GC noted that the evidence for pharmacological interventions for cognitive decline or dementia is only in people with Down’s syndrome and that there were no trials in people with learning disabilities that do not have Down’s syndrome. The distinction between people with and without Down’s syndrome is important in view of physiological differences attributable to chromosome 21. Treatment and prevention of all mental health problems in people with learning disabilities Despite insufficient evidence to suggest that effectiveness or safety of pharmacological interventions is different for people with learning disabilities compared with the general population, the GC was concerned about a number of issues related to the use of drugs in people with learning disabilities such as the possibility of side effects and inability to communicate/carer observation of these. Since there was insufficient evidence to suggest that there should be different recommendations on pharmacological management in people with learning disabilities than the general population, the GC decided to cross-refer to the recommendations in the existing NICE guidelines (when there are no contra-indications) but to deal with the additional issues through formal consensus. The GC decided on the basis of the outcome of the nominal group technique to develop recommendations in the following areas:
A number of contextual factors were highlighted during the nominal group technique which were deemed to be important to address, and recommendations were made to incorporate these issues:
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