Berntsson, A

Jönsson, L

Lindström, E

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PMH56 A PATIENT PERSPECTIVE ON SIDE EFFECTS OF ANTIPSYCHOTIC THERAPY: THE TOOL INSTRUMENT 

Paris Abstracts A361
PMH54
COMPLEX ATTENTION-DEFICIT/HYPERACTIVITY DISORDER: PATIENT 
CHARACTERISTICS, HEALTH CARE UTILIZATION AND COSTS IN A 
RETROSPECTIVE OBSERVATIONAL CLAIMS STUDY
Hess G1, Sasane R2, Hill J1, Hodgkins P2, Shah MR1
1SDI Health, Plymouth Meeting, PA, USA, 2Shire Pharmaceuticals, Wayne, PA, USA
OBJECTIVES: To elucidate the characteristics of complex Attention-Deﬁcit/Hyperac-
tivity Disorder (ADHD) and associated health care utilization and costs in children 
and adolescents. METHODS: Patients (aged 6–17) diagnosed with ADHD between 
November 2005 and October 2007 and with medical/pharmacy claims for q1 year 
after the index diagnosis were identiﬁed retrospectively from SDI’s databases of 
patient-level medical and pharmacy claims. Because patients with ADHD and associ-
ated comorbidities were likely to require the most treatment (and therefore incur 
higher health care charges), we hypothesized that total cost of ADHD prescriptions 
and ofﬁce visits could serve as a proxy for a more “complex” patient. Costs for ADHD 
prescriptions and ADHD ofﬁce visits were aggregated, and patients were stratiﬁed into 
high- (top 25% of total charges), medium- (middle 50%), and low- (bottom 25%) 
cost groups. RESULTS: In total, 10,362 patients were stratiﬁed, with 2591 patients 
in the high-cost, 5170 in the medium-cost, and 2601 in the low-cost group. More than 
two thirds of the patients were aged 6–12 years, and 70% were male. The prevalence 
of most psychiatric and other comorbidities was higher in the high-cost group than 
in the medium-cost group (P  0.05 for 10 of 14 comorbidities) or in the low-cost 
group (P  0.05 for 9 comorbidities). High-cost patients were also more likely to be 
diagnosed younger, be treated by a specialist, and use augmented pharmacotherapy 
for their ADHD. Health care resource utilization in the high-cost group was 1.77 times 
greater than in the medium-cost group and 3.52 times greater than in the low-cost 
group (P  0.001 for both comparisons). The proportion of ADHD physician visits 
with procedure codes indicating higher disease burden and complexity was also sig-
niﬁcantly greater (P  0.001) for the high-cost group. CONCLUSIONS: This study 
identiﬁed a subset of complex pediatric and adolescent ADHD patients with unique 
characteristics and higher relative resource use. Supported by funding from Shire 
Development Inc.
MENTAL HEALTH – Patient-Reported Outcomes Studies
PMH55
DEPRESSION TREATMENT ADHERENCE AMONG DEPRESSION 
PATIENTS WITH COMORBIDITY
Rhee Y, Jordan N, Ziffra M, Mohr D
Northwestern University, Chicago, IL, USA
OBJECTIVES: To examine the impact of comorbidity on treatment options and treat-
ment adherence among depression patients in employer health plans. METHODS: We 
used 165,569 records of administrative claims data between September 2002 and 
March 2004 for employed between 18 to 64 years old. Depression was identiﬁed using 
ICD-9 diagnosis codes. Treatment adherence was deﬁned as ﬁnding more than 2 pre-
scriptions for antidepressants (30 days supply) or having more than 5 psychotherapy 
sessions. Multivariate logistic regression analyses were performed to examine impact 
of comorbidity on adherence to treatment among depression patients who initiated 
treatment. RESULTS: Among eligible members, 2567(1.5%) had a primary diagnosis 
of depression and received treatment. Over 70% were female and the average age was 
42.6 years. Approximately half (49.2%) received medication only; 29.3 % received 
psychotherapy and medication; and 15.7% received psychotherapy without medica-
tions. The average number of prescribed antidepressants was 4.4 among those took 
any medications. Among those who had psychotherapy, 51.4% received more than 5 
secessions. The most frequent comorbid mental disorders were anxiety (25.3%), 
adjustment disorder (9.1%), alcohol use (3.5%) and substance abuse (1.9%) and 
physical comorbid conditions were musculoskeletal and chronic pain (MSCP, 29.9%), 
injuries (17.5%), hypertension (13.3%), asthma (6.7%), diabetes (6.4%), arthritis 
(5.1%), and urinary tract infection (4.0%). Depression patients with anxiety (OR  
1.9), or adjustment disorder (OR  1.4) were signiﬁcantly more likely to receive psy-
chotherapy (p  0.05), but signiﬁcantly less likely to use medication only. Comorbid 
HIV (OR  1.7), arthritis (OR  0.5), anxiety (OR  0.4) and MSCP (OR  0.3) were 
signiﬁcantly associated with receiving both medication and psychotherapy (p  0.001). 
Among patients who received both treatments, those with hypertension were signiﬁ-
cantly less likely to adhere to either treatment. Among those who initiated psycho-
therapy, comorbid anxiety (OR  0.6) was signiﬁcantly associated with treatment 
adherence (p  0.001). CONCLUSIONS: Among depression patients, having 
comorbid mental disorders was signiﬁcantly associated with use of and adherence 
to psychotherapy treatment.
PMH56
A PATIENT PERSPECTIVE ON SIDE EFFECTS OF ANTIPSYCHOTIC 
THERAPY: THE TOOL INSTRUMENT
Lindström E1, Jönsson L2, Berntsson A3
1Malmö University Hospital, Malmö, Sweden, 2i3 Innovus, Stockholm, Sweden, 3Danderyds 
hospital, STOCKHOLM, Sweden
OBJECTIVES: Pharmacotherapy is the most important component of care for patients 
with schizophrenia and related disorders. However, side effects adversely affect 
patient’s health-related quality of life. A novel self-assessment instrument (Tolerability 
and quality of Life, TooL) is presented to assess patient experiences of side effects. 
METHODS: The instrument was developed to reﬂect the subjective perception of side 
effects in patients treated with antipsychotic medication. TooL was developed by an 
expert panel of four experienced psychiatrists with a special interest in the treatment 
of schizophrenia, schizoaffective or bipolar syndrome. TooL has eight domains reﬂect-
ing important aspects for patient well-being: anxiety and depression, usual activities, 
fatigue or weakness, body weight, stiffness and tremor, bodily restlessness, sexual 
function and vertigo or nausea. TooL was completed by 220 patients with schizophre-
nia, bipolar disorder or schizoaffective disorder in a cross-sectional observational 
study. Reliability and validity were estimated by correlations with existing scales 
assessing presence of side effects, symptom severity and HRQoL (UKU, PANSS, 
MADRS, SWN, EQ-5D, and VAS). RESULTS: Responses on TooL demonstrated 
that frequent experiences of side-effects impact the well-being of patients. Validity 
was supported by signiﬁcant correlations with other instruments. TooL correlated 
with corresponding domains in the UKU scale. The MADRS score correlated strongest 
with anxiety, depression, fatigue or weakness. The global PANSS score signiﬁcantly 
correlated with all domains except Weight gain, Stiffness and Sexual function. TooL 
also correlated to the VAS score, EQ-5D, and the disease-speciﬁc scale SWN. 
 CONCLUSIONS: TooL is a new instrument for patient-reported assessment of the 
impact of side-effects of antipsychotic medication. The instrument can be of signiﬁcant 
value in a clinical setting as a decision tool to guide treatment choices and serve as an 
important input to evaluations of antipsychotic treatment. Patient experiences of side 
effects are a highly relevant outcome measure that may determine the long-term 
success of therapy.
PMH57
NON-ADHERENCE TO ORAL ANTIPSYCHOTICS IN SCHIZOPHRENIA: 
RELAPSE AND UTILIZATION OF HEALTH CARE RESOURCES IN A  
6-MONTH FOLLOW-UP PERIOD
San L1, Valladares A2, Bernardo M3, Olivares JM4, Ciudad A2, García-Polavieja P2, 
Yruretagoyena B2, Dilla T2, Gilaberte I2
1Hospital Sant Joan de Déu, Esplugues de Llobregat, Barcelona, Spain, 2Lilly, S.A., Alcobendas, 
Madrid, Spain, 3Hospital Clinic, Barcelona, Barcelona, Spain, 4Hospital Meixoeiro—Complejo 
Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain
OBJECTIVES: To investigate the clinical proﬁles, modiﬁcation of therapeutic strate-
gies, relapse rate and resource utilization in patients with schizophrenia who are 
at risk of non-adherence to oral antipsychotic (AP) medication. METHODS: A 
Spanish cohort of 596 outpatients with schizophrenia whose therapy was modiﬁed 
because of risk of non-adherence to oral AP medication was followed during 12 
months. Baseline and 6-month data on sociodemographic and clinical characteristics, 
as well as on resource utilization are described. RESULTS: Patients’ mean (SD) age 
was 40.1 (11.1) years, and 64% were males. The median (IQR) time-since-diagnosis 
was 14 (15) years. Within the prior 6 months, 124 (21%) had been hospitalized at 
least once with mean duration of 26 days. Patients had severe symptoms (CGI-S mean 
score of 4.3), poor quality of life (mean EuroQol-5D health-status value of 0.6) 
and functional status (mean SOFAS score of 50.6). Baseline non-pharmacologic thera-
pies were modiﬁed in 189 (32%) patients, AP medication in 503 (85%) and concomi-
tant medication in 15%. Modiﬁcations of AP medications were mostly dose 
adjustments (64%). Depot formulation was started by 15%. After 6 months, 65 
patients (11%) relapsed. These had worse CGI-S and SOFAS scores than patients who 
did not relapse (4.2 and 51.4 versus 3.7 and 58.6, respectively), whilst EuroQol-5D 
scores were similar (0.7 in both groups). Hospitalization was required by 35 out of 
65 (53.9%) patients who relapsed (38.7 days on average), but just by 5 out of 531 
(0.9%) of those who did not relapse (5.4 days on average). Visits to emergency room 
occurred, respectively, in 44 out of 65 (67.7%) and in 74 out of 531 patients (14%). 
CONCLUSIONS: After baseline treatment modiﬁcation the proportion of patients 
requiring hospitalizations within 6 months was reduced. Patients who relapsed con-
sumed more resources.
PMH58
TOOL: MULTI-ATTRIBUTE UTILITY FUNCTION REFLECTING PATIENT 
EXPERIENCE OF SIDE EFFECTS TO ANTIPSYCHOTIC THERAPY
Jönsson L1, Lang A2, Lindström E3
1i3 Innovus, Stockholm, Sweden, 2i3 Innovus, 11164, Sweden, 3Malmö University Hospital, 
Malmö, Sweden
OBJECTIVES: The main effects of pharmaceutical treatment in schizophrenia are 
symptom relief and relapse prevention. Antipsychotic treatment is, however, associ-
ated with adverse effects that impact patient well-being. A novel instrument, TooL 
(Tolerability and quality of Life), measures health-related quality of life with antipsy-
chotic medication across eight different dimensions: mood, function capabilities, 
fatigue, weight gain, stiffness and tremor, physical restlessness, sexual dysfunction and 
nausea. This study aimed to develop a function linking responses to TooL to health 
utility values. METHODS: A multi-attribute utility function (MAUF) was developed 
based on the instrument for patients with schizophrenia, schizoaffective or bipolar 
syndrome on antipsychotic treatment to allow estimation of health utilities associated 
with antipsychotic treatments and their side effects. 220 patients with stable schizo-
phrenia, schizoaffective disorder or bipolar disorder completed a set of ratings to 
facilitate the estimation of a MAUF linking each possible state in the classiﬁcation 
system to a utility value. RESULTS: A total of 183 of the 220 patients provided 
complete and consistent ratings allowing an average utility function to be estimated. 
The TooL utility ratings correlated signiﬁcantly with disease speciﬁc instruments for 
disease severity (MADRS and PANSS) and quality of well-being (SWN). Utility ratings 


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PMH56 A PATIENT PERSPECTIVE ON SIDE EFFECTS OF ANTIPSYCHOTIC THERAPY: THE TOOL INSTRUMENT

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