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TitleLamotrigine for people with borderline personality disorder
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Table of Contents
                            Health Technology Assessment 2018; Vol. 22; No. 17
	List of tables
	List of figures
	List of abbreviations
	Plain English summary
	Scientific summary
	Chapter 1 Introduction
		The importance of borderline personality disorder
		Treatment of borderline personality disorder
		The role of mood stabilisers
		The LABILE study
	Chapter 2 Methods
		Design
		Study setting
		Participants
		Interventions
		Usual care
		Assessments
			Assessment of eligibility and for determining randomisation strata
			Primary outcome
			Secondary outcomes
			Adherence
		Blinding
			Unblinding at the end of the follow-up period
			Emergency unblinding
		Study logistics
			Recruitment
			Screening and baseline
			Assignment of interventions
			Follow-up
		Data management
		Sample size
		Statistical analyses
			Preliminary analyses
			Primary analysis
			Secondary analyses
			Sensitivity analyses
			Complier-average causal effect analyses
			Analyses of secondary outcomes
			Safety reporting
		Health economics analysis
			Calculation of costs
			Calculation of quality-adjusted life-years
			Data analysis
			Cost-effectiveness analysis
			Sensitivity analysis
		Service user involvement
		Ethics approval and governance
		Changes to trial design
			Change to design between funding proposal and trial commencement
			Change to design after trial commencement
	Chapter 3 Results
		Baseline characteristics of randomised participants
		Adherence to protocol and trial medication
		Primary outcome
		Secondary outcomes
		Safety
	Chapter 4 Economic evaluation
		Service use
		Cost
		Outcomes
		Cost-effectiveness analysis
		Sensitivity analysis
	Chapter 5 Discussion
		Strengths and weaknesses of the study
		Comparison with results of previous trials
		Implications for clinical practice
		Future research
		Conclusions
	Acknowledgements
	References
	Appendix 1 Pro forma for recording possible side effects of trial medication
	Appendix 2 Modified version of the Adult Service Use Schedule as used in this trial
	Appendix 3 Unit costs and sources for economic evaluation
	Appendix 4 Secondary outcomes at secondary time points
                        
Document Text Contents
Page 1

HEALTH TECHNOLOGY ASSESSMENT
VOLUME 22 ISSUE 17 APRIL 2018

ISSN 1366-5278

DOI 10.3310/hta22170

Lamotrigine for people with borderline personality
disorder: a RCT

Mike J Crawford, Rahil Sanatinia, Barbara Barrett, Gillian Cunningham,
Oliver Dale, Poushali Ganguli, Geoff Lawrence-Smith,
Verity C Leeson, Fenella Lemonsky, Georgia Lykomitrou-Matthews,
Alan Montgomery, Richard Morriss, Jasna Munjiza, Carol Paton,
Iwona Skorodzien, Vineet Singh, Wei Tan, Peter Tyrer
and Joseph G Reilly on behalf of the LABILE study team

Page 47

Chapter 4 Economic evaluation

The availability of service-use data at each follow-up period is summarised in Table 13, which shows thatfull service-use information was available for 61% of participants in the lamotrigine group and 57% of
participants in the placebo group.

Service use

All resources used by study participants over the 52-week follow-up are summarised in Table 14. There are
some noticeable differences in the use of hospital services over the follow-up period; participants in the
lamotrigine group had an average of 12 nights of inpatient care compared with six nights of inpatient care
in the placebo group. The SDs and ranges reported alongside the means in the table suggest that this
difference in mean costs was because of a small number of participants who had long stays in hospital.
Outpatient appointments and accident and emergency attendances were similar between groups.

TABLE 13 Availability of service-use data at follow-up

Time point

Treatment group, n (%)

Lamotrigine Placebo

Baseline 135 (100) 137 (100)

12 weeks 110 (80) 104 (77)

24 weeks 98 (72) 97 (72)

52 weeks 91 (66) 88 (65)

All periods 83 (61) 77 (57)

TABLE 14 Use of services per participant over the 52-week follow-up period

Service

Treatment group

Lamotrigine (n= 83) Placebo (n= 77)

Mean (SD)a Range %b Mean (SD)a Range %b

Inpatient nights 12.66 (34.59) 0–239 46 6.37 (17.95) 0–127 35

Outpatient contacts 4.47 (7.26) 0–39 67 5.36 (9.69) 0–66 77

A&E contacts 3.86 (8.47) 0–69 70 3.52 (5.90) 0–28 61

General practice 20.43 (24.13) 0–157 98 17.16 (16.57) 1–83 100

Health care 28.90 (23.19) 0–85 95 21.23 (25.60) 0–167 95

Mental health services 12.65 (15.13) 0–84 96 13.29 (19.56) 0–148 96

Social care 13.88 (49.36) 0–429 73 12.25 (36.37) 0–291 70

Complementary services 1.02 (9.33) 0–85 1 0.08 (0.68) 0–6 1

Any medication – – 93 – – 95

Any antipsychotic medication – – 16 – – 17

A&E, accident and emergency department.
a The mean refers to the number of visits to the service.
b The percentage refers to the proportion of participants using each of these services at least once.

DOI: 10.3310/hta22170 HEALTH TECHNOLOGY ASSESSMENT 2018 VOL. 22 NO. 17

© Queen’s Printer and Controller of HMSO 2018. This work was produced by Crawford et al. under the terms of a commissioning contract issued by the Secretary of State for
Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional
journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should
be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science
Park, Southampton SO16 7NS, UK.

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Page 48

In general, the use of community health services was similar in both groups. Between 98% and 100%
of participants saw their GP at least once over the period of follow-up, and, on average, the number of
times a participant saw their GP was between 17 and 20. Use of other health-care services (practice nurse,
walk-in clinic, dietitian, physiotherapist, podiatrist) and community mental health services (psychiatrist,
psychologist, care co-ordinator/key worker, psychiatric nurse, counsellor/therapist, group therapy, day
centre, drug and alcohol services, eating disorder services) was equally high.

Cost

At baseline, on average, costs were £5618 in the lamotrigine group and £3555 in the placebo group.
The adjusted difference of £2376 was not statistically significant (95% CI –£108.13 to £4860.37; p = 0.061).
The mean average cost differences between the groups are detailed in Table 15. The average drug and
prescribing cost of lamotrigine was £242.69. The difference in hospital costs between the lamotrigine and
placebo groups (£7294.09 vs. £4711.22) reflects the different average duration of inpatient stays. Other
medication costs were also higher in the lamotrigine group (£674.10 vs. £302.64), resulting in higher
average total costs in the lamotrigine group (£12,244.32) than in the placebo group (£8495.41), although
this difference in cost was not statistically significant (95% CI –£1886.61 to £3169.83; p = 0.617).

Outcomes

The EQ-5D-3L scores at baseline and all follow-up points are detailed in Table 16. There were very few
between-group differences in EQ-5D-3L scores and the resulting QALYs. The QALYs in the lamotrigine
group were 0.287 and in the placebo group were 0.299, not significantly different (95% CI –0.057 to
0.034; p = 0.612).

Cost-effectiveness analysis

The ICER for the QALY outcome using adjusted mean differences is not reported. As it was negative,
the lamotrigine treatment was dominated by the placebo. The ICER for ZAN-BPD using adjusted mean
differences was £641.61/0.22 = £2916 per unit change in ZAN-BPD score.

The uncertainty around the ICER for QALYs is shown in Figure 2. The bootstrapped replications are present
in all four quadrants of the plane: 44% appear in the less effective, more costly, quadrant; 23% in the
more costly, more effective, quadrant; 21% in the less effective, less costly, quadrant; and 12% in the less
costly, more effective, quadrant. The green line denotes the willingness-to-pay value of £20,000 per QALY.

TABLE 15 Total costs (£) per participant over the 52-week follow-up period

Cost item

Treatment group, mean cost (SD)

Differencea 95% CIa p-valueaLamotrigine (n= 83) Placebo (n= 77)

Intervention 242.69 (95.99) 0.00 (0.00) 244.78 222.71 to 266.84

Hospital 7294.09 (15,894.87) 4711.22 (10,057.64) 416.76 –1798.50 to 2632.01

Community 4033.44 (3599.40) 3481.54 (3090.88) 158.94 –437.91 to 755.79

Medication 674.10 (2457.12) 302.64 (971.04) 23.73 –302.89 to 350.35

Total 12,244.32 (17,442.80) 8495.41 (11,349.10) 641.61 –1886.61 to 3169.83 0.617

a Adjusted for by site, baseline ZAN-BPD score, severity of personality disorder (simple or complex) and score on the HCL-32
(a score of ≥ 14 or < 14).

ECONOMIC EVALUATION

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expressed are those of the author(s) and not necessarily
those of the NHS, the NIHR or the Department of Health

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