The utility of novel outcome measures in a naturalistic evaluation of schizophrenia treatment

Figures & data

Table 1 Demographic profile of 50 people with schizophrenia prescribed PP

Population	Total (N=50a)	Continuation at 6 months (n=35)	Discontinuation before 6 months (n=14)	Continuation at 12 months (n=30)	Discontinuation before 12 months (n=20)
Age (years)
Mean (± SD)	42 (13)	41 (13)	42 (13)	42 (14)	41 (14)
Gender, n (%)
Male	38 (76)	27 (71)	11 (29)	24 (63)	14 (32)
Female	12 (24)	8 (67)	3 (25)a	6 (50)	5 (42)a
Ethnicity, n (%)
Black	2 (4)	0 (0)	2 (100)	0 (0)	2 (100)
White	28 (56)	20 (71)	7 (25)a	17 (61)	10 (36)a
Otherb	19 (38)	15 (79)	4 (21)	13 (68)	6 (32)
Unknown	1 (2)	0 (0)	1 (100)	0 (0)	1 (100)
Care setting, n (%)
Inpatient	47 (94)	32 (68)	14 (30)a	27 (57)	19 (40)a
Outpatient	3 (6)	3 (100)	0 (0)	3 (100)	0 (0)
Treatment 12 months prior to PP, n (%)
Risperidone oral/LAI	24 (48)	17 (71)	6 (25)a	15 (63)	8 (33)a
Risperidone oral/LAI and other drug	9 (18)	7 (78)	2 (22)	6 (67)	3 (33)
None	2 (4)	1 (50)	1 (50)	1 (50)	1 (50)
Others	15 (30)	10 (67)	5 (33)	8 (53)	7 (47)
Comorbid substance use, n (%)
Yes	17 (34)	12 (71)	5 (29)	11 (65)	6 (35)
No	33 (66)	23 (70)	9 (27)a	19 (58)	13 (39)a

Notes:

a One lost to follow up (65 years, female, white) and one patient died, therefore percentages do not total 100% due to missing data.

b Other ethnicity included 13 Asian or Asian British.

Abbreviations: LAI, long-acting injection; PP, paliperidone palmitate.

Table 2 MSQ descriptive statistics relating to paliperidone palmitate

Descriptive statistics	T0 (n=50)	T6 (n=35)	T12 (n=30)
Completed MSQ, n (%)	38 (76)	13 (37)	22 (74)
Not completed MSQ
Lack of insight, n (%)	5 (10)	n/a	4 (13)
Refused, n (%)	1 (2)	n/a	n/a
Missing data, n (%)	6 (12)	22 (63)	4 (13)
Least squares mean	3.8 (0.4)	5.3 (0.5)b	5.1 (0.4)c
MSQ score (SE)
Rangea	1–7	2–7	3–7
Minimum value 1, n (%)	8 (21)	2 (15)	3 (14)
Maximum value 7, n (%)	3 (8)	3 (23)	1 (5)

Notes: T0, initial baseline; T6, treatment with PP at 6 months, and T12, treatment with PP at 12 months.

a Range 1 (extremely dissatisfied) to 7 (extremely satisfied).

b T6, p-value (adjusted) =0.0045, difference =1.5 (SE 0.47).

c T12, p-value (adjusted) =0.0043, difference =1.34 (SE 0.4).

Abbreviations: MSQ, Medication Satisfaction Questionnaire; n/a, not applicable; PP, paliperidone palmitate; SE, standard error.

Figure 1 Line graph to compare the least squares mean for the cluster score data of paliperidone palmitate and the other antipsychotic drugs group ranked by monetary costs per day (1 lowest cost to 7 highest cost).

Notes: Paliperidone palmitate (T0, n=48; T6, n=34; and T12, n=30) and other antipsychotic drugs group (T0 n=32, T6 n=21, and T12 n=28). T0, initial baseline; T6, treatment at 6 months; and T12, treatment at 12 months. ^aT0 versus T6, p-value (adj) =0.01, difference =−1 (SE 0.4). ^bT0 versus T12, p-value (adj) =0.0003, difference =−1.5 (SE 0.4).
Abbreviations: adj, adjusted; SE, standard error.

Figure 2 Clustered column chart to compare the least squares mean for the aggregated scores (0–8) of Severe Disturbance for paliperidone palmitate and the other antipsychotic drugs group.

Notes: Severe Disturbance, containing overactive, aggressive, disruptive, or agitated behavior and problems associated with hallucinations and delusions (scales 1 and 6 from HoNOS). Paliperidone palmitate (T0, n=48; T6, n=34; and T12, n=30) and other antipsychotic drugs group (T0, n=32; T6, n=21; and T12, n=28). T0, initial baseline; T6, treatment at 6 months; and T12, treatment at 12 months. ^aT0 versus T6, p-value (adj) =0.0032, difference =0.85 (SE 0.26). ^bT0 versus T12, p-value (adj) =0.002, difference =1.1 (SE 0.3).
Abbreviations: adj, adjusted; HoNOS, Health of the Nation Outcome Scales; SE, standard error.

Figure 3 Cox PH regression showing the time to discharge of patients prescribed either PP (n=34) or those in the other antipsychotic drugs group (n=27).

Abbreviations: PH, proportional hazards; PP, paliperidone palmitate; PPLAI, paliperidone palmitate long-acting injection.

Table S1 Key to MHCT Care clusters 10–17 (“psychosis” super cluster)

Care cluster	Description and likely primary diagnosis
Care cluster 10: first episode psychosis	This group will be presenting to the service for the first time with mild to severe psychotic phenomena. They may also have depressed mood and/or anxiety or other behaviors. Drinking or drug-taking may be present but will not be the only problem. Likely to include (F20–F29) schizophrenia, schizotypal and delusional disorders, and F31 bipolar disorder.
Care cluster 11: ongoing recurrent psychosis (low symptoms)	This group has a history of psychotic symptoms that are currently controlled and causing minor problems if any at all. They are currently experiencing a sustained period of recovery where they are capable of full or near functioning. However, there may be impairment in self-esteem and efficacy and vulnerability to life. Likely to include (F20–F29) schizophrenia, schizotypal and delusional disorders, F30 manic episode, and F31 bipolar affective disorder.
Care cluster 12: ongoing or recurrent psychosis (high disability)	This group has a history of psychotic symptoms with a significant disability with major impact on role functioning. They are likely to be vulnerable to abuse or exploitation. Likely to include (F20–F29) schizophrenia, schizotypal and delusional disorders, F30 manic episode, F31 bipolar affective disorder.
Care cluster 13: ongoing or recurrent psychosis (high symptom and disability)	This group will have a history of psychotic symptoms which are not controlled. They will present with severe to very severe psychotic symptoms and some anxiety or depression. They have a significant disability with major impact on role functioning. Likely to include (F20–F29) schizophrenia, schizotypal and delusional disorders, F30 manic episode, and F31 bipolar affective disorder.
Care cluster 14: psychotic crisis	They will be experiencing an acute psychotic episode with severe symptoms that cause severe disruption to role functioning. They may present as vulnerable and a risk to others or themselves. Likely to include (F20–F29) schizophrenia, schizotypal and delusional disorders, F30 manic episode, and F31 bipolar affective disorder.
Care cluster 15: severe psychotic depression	This group will be suffering from an acute episode of moderate to severe depressive symptoms. Hallucinations and delusions will be present. It is likely that this group will present a risk of non-accidental self-injury and have disruption in many areas of their lives. Likely to include, F32.3 severe depressive episode with psychotic symptoms.
Care cluster 16: psychosis and affective disorder (high substance misuse and engagement)	This group has enduring, moderate to severe psychotic or bipolar affective symptoms with unstable, chaotic lifestyles and co-existing problem drinking or drug taking. They may present a risk to self and others and engage poorly with services. Role functioning is often globally impaired. Likely to include (F10–F19) mental and behavioral disorders due to psychoactive substance use, (F20–F29) schizophrenia, schizotypal and delusional disorders, and bipolar disorder.
Care cluster 17: psychosis and affective disorder – difficult to engage	This group has moderate to severe psychotic symptoms with unstable, chaotic lifestyles. There may be some problems with drugs or alcohol not severe enough to warrant care associated with cluster 16. This group has a history of non-concordance, is vulnerable and engages poorly with services. Likely to include (F20–F29) schizophrenia, schizotypal and delusional disorders, and bipolar.

Notes: Adapted with permission from Mental Health Clustering Booklet (V5.0) (2016/17). Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499475/Annex_B4_Mental_health_clustering_booklet.pdf.¹ The ‘F’ codes are defined by the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)-WHO Version for 2016.²

Abbreviation: MHCT, mental health clustering tool.

Table S2 Key to individual HoNOS items

HoNOS scales	Title of scales
Item 1	Overactive, aggressive, disruptive or agitated behavior
Item 2	Non-accidental self-injury
Item 3	Problem drinking or drug taking
Item 4	Cognitive problems
Item 5	Physical illness or disability problems
Item 6	Hallucinations and delusions
Item 7	Depressed mood
Item 8	Other mental and behavioral problems
Item 9	Problems with relationships
Item 10	Problems with activities of daily living
Item 11	Problems with living conditions
Item 12	Problems with occupation and activities
Item 13	Strong unreasonable beliefs

Note: Adapted from Health of the Nation Outcome Scales (HoNOS). Available from: https://www.rcpsych.ac.uk/pdf/HoNOS-secure%20Glossary%20v2b%20Feb%2007.pdf. ©Royal College of Psychiatrists 1996.³

Table S3 Cluster-score cost ranking according to financial outlay

Cluster score	Indicative cluster costs value/day (£)	Linear ranking
10	29.06	3
11	15.22	1
12	26.45	2
13	40.57	5
14	86.23	8
15	46.56	6
16	35.84	4
17	53.24	7

Notes: The indicative cluster costs are derived from 2011 to 2012 reference costs. NHS. Payment by Results Guidance for 2013–14; 2013. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/232162/Mental_Health_PbR_Guidance_for_2013-14.pdf.⁴

Mental Health Clustering Booklet. (V5.0) (2016/17)NHS England Publications Available from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499475/Annex_B4_Mental_health_clustering_booklet.pdfAccessed January 19, 2018

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International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)-WHO Version for 2016 Available from: http://apps.who.int/classifications/icd10/browse/2016/en#/VAccessed January 19, 2018

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Health of the Nation Outcome Scales (HoNOS) Available from: https://www.rcpsych.ac.uk/pdf/HoNOS-secure%20Glossary%20v2b%20Feb%2007.pdfAccessed January 19, 2018

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NHSPayment by Results Guidance for 2013–142013 Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/232162/Mental_Health_PbR_Guidance_for_2013-14.pdfAccessed May 10, 2017

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