Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO): Baseline Characteristics of Pan-regional Observational Data from More than 17,000 Patients*

J. Karagianis; D. Novick; J. Pecenak; J. M. Haro; M. Dossenbach; T. Treuer; W. Montgomery; R. Walton; A. J. Lowry

Int J Clin Pract. 2009;63(11):1578-1588.

Results

The merged W-SOHO database comprises a total of 17,384 patients recruited from 37 countries. Of these 37 countries, ~57% (n = 21)¹ are considered to be emerging or developing economies, based on International Monetary Fund (IMF) guidelines (as Puerto Rico is not a member of the IMF, it is of indeterminate status).^[24] This represents 31% (n = 5455) of the study population. Using the World Bank classifications (which are based on Gross National Income), lower-middle (n = 8), upper-middle (n = 10) and high income (n = 18) countries² are all represented in this study population.^[25] For analytical purposes, the countries were grouped into six regions: EA (Korea n = 821, Malaysia n = 105, Taiwan n = 297); CEE (Czech Republic n = 477, Hungary n = 189, Lithuania n = 100, Poland n = 599, Romania n = 136, Russia n = 159, Slovakia n = 301, Slovenia n = 214); NE (Denmark n = 31, France n = 915, Germany n = 2869, Ireland n = 53, Netherlands n = 160, UK n = 263); SE (Greece n = 690, Italy n = 2869, Israel n = 76 ³, Portugal n = 166, Spain n = 1987); LA (Argentina n = 349, Chile n = 152, Colombia n = 197, patients from Costa Rica, El Salvador, Guatemala and Honduras were pooled n = 267, Mexico n = 1019, Peru n = 96, Puerto Rico n = 217, Venezuela n = 269); NAME (Algeria n = 300, Egypt n = 183, Turkey n = 662, Saudi Arabia n = 196). Of the 1563 participating psychiatrists, a majority were working in either combined private/public or public practice in an urban setting when enrolment began (Table 1).

Overall, the W-SOHO study population is a moderately ill group of outpatients aged 38 (± 13 years), with a median disease history of 7 years (interquartile range 1–16 years), 10% of whom were receiving an antipsychotic medication for schizophrenia for the first time. As shown in Table 1, regional variations were evident in most demographic and clinical characteristics. In particular, East Asian patients were consistently less severe across all CGI-SCH domains, and reported the lowest rates of sexual dysfunction; use of depot typical antipsychotics in the 6 months prior to the study was also much less common in EA than in other regions. Depot typicals were most frequently prescribed in CEE, 3 in 10 patients having been treated with this class of medication in the 6 months prior to enrolment. CEE patients also demonstrated the highest rate of prestudy clozapine use, and were the least likely to be receiving an antipsychotic for the first time, despite similar duration of disease, clinical symptomatology and hospital admissions to patients in other regions. Of particular note, the prevalence of TD was 1.6–2.2 times greater in the Northern European sample when compared with the prevalence observed in the other individual regional groups. Adverse events were prevalent across all regions; on average, 50% of patients taking antipsychotics were experiencing EPS at baseline (range 41–59%), and 62% of patients reported sexual dysfunction in the month prior to baseline (range 34–67%).

In addition to clinical symptomatology, functional deficits were a pronounced feature of this study population. Only 16–23% of patients were in paid employment, and as many as 69% (LA and NAME) were in dependent housing (Table 2). Twenty-five percent of patients in SE were in a spousal or primary partner relationship, compared with 47% of East Asian patients; however, socialising outside of the primary relationship was more consistent across regions (with the exception of NAME), with 63% of patients reporting social activity in the month prior to study entry on average. Both substance and alcohol abuse/dependency varied across the regions, with the lowest prevalence in EA, CEE and NAME. Overall, 31% of patients had a recent history (past 6 months) of verbal or physical hostility or aggression, this featured most frequently in patients in LA and NAME, with rates almost double those seen in CEE and NE (42% and 44% vs. 23% respectively). Suicidal ideation appeared to be more common in patients from NE and LA, with 30% of patients having a history of attempted suicide (Table 2). However, there appears to be a temporal shift in this trend, with NAME emerging as a region with high prevalence for recent suicide attempts (8% of patients attempted suicide in the 6 months prior to baseline), and NE showing improvement (5% vs. 9%, NE vs. LA, attempts 6 months prebaseline). Patients in NAME and NE reported the worst self-rated health states/quality of life (median EQ-VAS scores of 40 and 41 respectively, Table 2), which were even lower than the 25% percentile for EA.

Overall, 66% of investigators cited a lack of or incomplete effectiveness as a reason for initiating or changing medication. Irrespective of region, the rank order of the reasons reported was the same – lack of, or incomplete effectiveness, intolerability, patient request and incomplete adherence to prescribed medication (Table 3). Little regional variation in the proportion of patients who changed or initiated medication because of issues of effectiveness (range 61–73%) or intolerability (31–40%) was found. In NE, there was more of an emphasis on intolerability and less on effectiveness driving changes in medication compared with the other regions. Patients entering the study were most likely to be receiving treatment with typical oral antipsychotics (alone or in combination with other antipsychotics, 56% overall prescriptions), followed by atypical oral antipsychotics (38% overall) and typical depot antipsychotics (22% overall). There were notable regional differences in antipsychotic prescription; EA demonstrated the highest rate of atypical oral use (46%) and the lowest use of typical depot agents (7%). Prescription patterns were reasonably consistent across Europe, although typical oral use was comparatively less common in NE, and typical depot use comparatively more common in CEE. LA and NAME shared some similarities in terms of a clear preference for typical oral medications; however, they differentiated in terms of typical depot use, with LA exhibiting the second lowest rate of use of this formulation. Antipsychotics were most frequently prescribed as monotherapy across all regions; however, this practice varied from being a clear preference in EA (82% of patients) to a marginal preference in NAME (53% of patients). Reflecting the preference for use of typical agents, typical monotherapy was more common than atypical monotherapy (62% patients on monotherapy overall), and represented 46% of patients. Haloperidol monotherapy accounted for 19–61% of patients on typical monotherapy, depending on the region. Forty to 76% of patients prescribed atypical antipsychotic monotherapy received risperidone, making it the most frequently prescribed monotherapy of this class. This was the only consistent finding across the regions in terms of monotherapy prescription of atypicals (Table 3). Antipsychotic polypharmacy (or combination therapy) was a popular practice in NAME, accounting for 47% of all patients; however, this varied across regions, representing only 18% of East Asian patients. As before, a majority (64% overall, range 74–60%) of these therapies involved combinations of typical agents, with combinations of typical and atypical agents being less popular (34% overall, range 24 to 39%), and co-prescription of atypical agents relatively rare (1.9% overall, range 0.2–3.0%).

Frequent use of concomitant psychotropic medications (excluding antipsychotics) was observed in all regions (74% overall, range 58–88%). Of the four classes of adjunctive agents reported, the least commonly prescribed were mood stabilisers and antidepressants respectively; this was consistent across all regions. Anxiolytic/hypnotic and anticholinergic usage patterns differed across regions, ranging from 57% in EA and 16% in NAME (anxiolytic/hypnotics), and 60% in EA to 26% in NE (anticholinergics, Table 3).

The study design resulted in systematic over-sampling of the olanzapine cohort; olanzapine monotherapy accounted for 4.7% (n = 601, Table 3) of all patients taking antipsychotics prior to study entry (prebaseline), whereas 54.8% (n = 7541) of patients were prescribed olanzapine monotherapy at the baseline visit (data not shown). The increase in the overall frequency of atypical oral prescription from 38% prebaseline (Table 3) to 86% postbaseline (data not shown), was also affected by the study design. However, it is interesting to note that the overall frequency of antipsychotic monotherapy remained fairly stable (74% vs. 79%, prior vs. at study entry), suggesting a clear preference for the use of antipsychotics as single agents, irrespective of class or agent. For reasons of the influence of the study design on antipsychotic prescription at the baseline visit, we have not included these data. Longitudinal analysis of prescribing practices (including dosage) will be discussed in future publications.

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Cite this: Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO): Baseline Characteristics of Pan-regional Observational Data from More than 17,000 Patients* - Medscape - Nov 01, 2009.

¹ Algeria, Argentina, Chile, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Guatemala, Honduras, Hungary, Lithuania, Malayasia, Mexico, Poland, Peru, Romania, Russia, Saudi Arabia, Turkey, Venezuela.
² Lower Middle Income: Algeria, Colombia, Egypt, El Salvador, Guatemala, Honduras, Peru, Turkey; Upper Middle Income: Argentina, Chile, Costa Rica, Malaysia, Lithuania, Mexico, Poland, Romania, Russia, Venezuela; High Income: Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Portugal, Puerto Rico, Netherlands, UK, Saudi Arabia, Slovakia, Slovenia, South Korea, Spain (no data available for Taiwan).
³ Israel has been included in the 'SE' grouping based on ethnicity, economic and health care systems.

Table 1. Demographic and clinical characteristics of patients in each region at study entry
Characteristic	All patients	East Asia	Europe			Latin America	North Africa and Middle East
Characteristic	All patients	East Asia	Central and Eastern Europe	Northern Europe	Southern Europe	Latin America	North Africa and Middle East
Number of patients	17,384	1223	2175	4291	5788	2566	1341
Proportion of all patients, %	100	7	12.5	24.7	33.3	14.8	7.7
Number of countries	37	3	8	6	5	11	4
Number of investigators	1563	92	215	503	354	274	125
Principle practice of investigator, % (n)
Type
Private	–	0.0 (0)	29.3 (63)	14.9 (75)	11.9 (42)	32.9 (90)	21.6 (27)
Public	–	13.0 (12)	34.0 (73)	47.7 (240)	47.7 (169)	11.7 (32)	26.4 (33)
Combined	–	0.0 (0)	36.3 (78)	35.4 (178)	37.0 (131)	55.5 (152)	44.0 (55)
Missing	–	87.0 (80)	0.5 (1)	2.0 (10)	3.4 (12)	0.0 (0)	8.0 (10)
Location
Urban	–	13.0 (12)	92.6 (199)	69.4 (349)	81.6 (289)	95.3 (261)	88.0 (110)
Non-urban	–	0.0 (0)	6.5 (14)	17.5 (88)	11.9 (42)	3.0 (8)	1.6 (2)
Missing	–	87.0 (80)	0.9 (2)	13.1 (66)	6.5 (23)	1.8 (5)	10.4 (13)
Gender, % Women	43.3	50	52.4	46.6	38.9	41.6	34.7
Age, mean (SD), years	38.0 (12.8)	35.0 (11.0)	38.0 (12.4)	40.7 (13.6)	38.8 (12.6)	35.7 (12.5)	32.5 (10.1)
Duration of illness, median (interquartile range)*, years	7 (1.0–16.0)	5 (1.0–11.0)	6 (1.0–15.0)	6 (1.0–16.0)	9 (2.0–19.0)	8 (2.0–17.0)	5 (1.0–11.0)
Never received an antipsychotic for schizophrenia, %	9.9	6.9	5.3	12.2	9.2	11.8	12.3
Schizophrenia-related admission to an inpatient facility (past 6 months), %	34.4	31.6	32.8	36.3	31.2	40.8	34.5
CGI-SCH score, mean (SD)
Overall	4.4 (1.0)	3.9 (1.0)	4.3 (1.0)	4.3 (1.0)	4.5 (1.0)	4.5 (1.1)	4.7 (1.0)
Positive	3.9 (1.4)	3.9 (1.3)	3.5 (1.5)	3.7 (1.5)	3.9 (1.4)	4.1 (1.3)	4.4 (1.4)
Negative	4.0 (1.3)	3.3 (1.2)	4.1 (1.2)	4.0 (1.3)	4.1 (1.3)	4.0 (1.4)	4.1 (1.4)
Depressive	3.4 (1.4)	2.8 (1.1)	3.3 (1.3)	3.4 (1.4)	3.5 (1.3)	3.4 (1.5)	3.3 (1.4)
Cognitive	3.7 (1.3)	2.9 (1.2)	3.9 (1.2)	3.9 (1.3)	3.7 (1.3)	3.9 (1.4)	3.8 (1.3)
Prior use of depot typical antipsychotics (past 6 months), %	23.2	6.9	30.8	23.1	24.7	20.5	25.1
Prior use of clozapine (past 6 months), %	5.3	3.1	10.8	5.3	3.6	5.6	4.9
Extrapyramidal symptoms†, % at baseline	49.6	40.8	49.4	45.8	50.1	59.4	50.1
Tardive dyskinesia†, % at baseline	11.2	9.8	10.9	17.2	8	11.1	7.8
Sexual Dysfunction, patient perception (past 4 weeks)‡, %	61.5	33.5	64.5	67	64.6	57.9	60

*Calculated from age of the patient at the first service contact for schizophrenia. †Only those patients taking antipsychotics are included, as the physician was instructed to assess those effects judged to be related to antipsychotic therapy. Denominators are; all patients 12,682, East Asia 925, Central and Eastern Europe 1715, Northern Europe 3079, Southern Europe 4334, Latin America 1754, North Africa and the Middle East 875. ‡Represents patients who reported either 'some problems with sexual function' or 'being unable to perform sexually'. CGI-SCH, Clinical Global Impressions Severity Scale-Schizophrenia version; SD, standard deviation.

Table 2. Baseline functional status for patients in each region
Characteristic	All patients	East Asia	Europe			Latin America	North Africa and Middle East
Characteristic	All patients	East Asia	Central and Eastern Europe	Northern Europe	Southern Europe	Latin America	North Africa and Middle East
Number of patients	17,384	1223	2175	4291	5788	2566	1341
Relationships, %
Involved in a spouse/partner relationship (today)	32.1	47.4	38.6	36.7	25.1	27.8	30.8
Social activities outside of the primary relationship (past 1 month)	62.9	56.8	62.5	71.5	64.3	56.9	47.4
Patient-rated health state (today), EuroQoL VAS score, median (interquartile range)*	50 (30–62)	60 (45–70)	50 (30–70)	41 (30–60)	48 (32–60)	50 (35–66)	40 (27–60)
Housing status, %
Independent	41.7	35.2	47.1	62.8	37.6	23.1	24.9
Dependent	49	46.8	47.3	24.2	54.5	69.2	70.6
Supervised	7.2	16.6	4.6	10	5.8	5.8	2.5
Hospitalised†	1.1	1.2	0.3	1.2	1.1	1.2	1.4
Homeless	0.2	0.1	0.1	0.1	0.2	0.3	0.1
Other	0.9	0.2	0.7	1.6	0.8	0.4	0.4
Employment status, %
Paid	19.0	16.2	19.3	22.6	17.3	17	20.8
Unpaid	3.3	1.6	0.9	5	3.6	3.5	2.1
Unemployed (available)	19.1	31.6	9.3	14.3	23.1	19.9	19.7
Unemployed (unavailable)	26.5	45.4	16	19.8	20	44.1	42.5
Retired	19.9	1.5	37.1	20.6	26.8	4.4	6.6
Other	12.1	3.6	17.3	17.7	9.2	11.2	8.2
Prior or current diagnosis of abuse or dependency,%
Substance	11.4	4.1	4.1	14.1	13.8	12.9	7.3
Alcohol	12.6	4.9	8.5	14.4	15	13.8	8.1
Exhibited verbal or physical hostility or aggression (past 6 months), %	30.5	26.8	23.3	23.3	31.2	41.7	43.8
Suicide, %
Ever attempted suicide	25.8	21.7	25.3	29.5	22.9	30.1	22
Attempted in the last 6 months	5.4	3.9	3.7	4.8	4.5	9.4	8

*Excludes patients from the Czech Republic, Egypt, Romania, Saudi Arabia and Slovakia, as validated quality of life scales were not administered in these countries. †Includes only patients who were hospitalised at enrolment for the purpose of changing or initiating antipsychotic treatment (and discharged within 14 days). EuroQoL VAS, EuroQoL EQ-5D scale and Visual Analogue Scale.

Table 3. Reasons for antipsychotic initiation or change and medication profile at study entry in each region
Medication history	All patients	East Asia	Europe			Latin America	North Africa and Middle East
Medication history	All patients	East Asia	Central and Eastern Europe	Northern Europe	Southern Europe	Latin America	North Africa and Middle East
Number of patients	17,384	1223	2175	4291	5788	2566	1341
Reason for initiation or change of medication, %
Lack of, or incomplete effectiveness	66	67	67.8	60.7	65.9	72.7	68.1
Intolerability	33.7	31.3	32.3	40	30.8	32.7	33.8
Lack of, or incomplete adherence	15.2	10.2	12.2	16	14.2	20.7	17.2
Patient request	25.4	13.6	26.9	35.8	22.7	21.6	18.4
None of the above	1.2	1.5	1.2	1.7	0.6	1.2	1.6
Medication taken at presentation to the baseline visit*
Antipsychotics†, % (n)
Atypical oral	37.9 (4805)	46.2 (427)	38.3 (656)	39.9 (1228)	38.7 (1677)	30.0 (527)	33.1 (290)
Typical oral	56.4 (7148)	57.8 (535)	55.3 (948)	49.6 (1526)	54.3 (2355)	66.4 (1165)	70.7 (619)
Typical depot	22.4 (2839)	6.6 (61)	29.9 (512)	24.5 (753)	23.2 (1006)	16.8 (294)	24.3 (213)
Antipsychotic monotherapy, % (n)	74.3 (9422)	82.1 (759)	68.2 (1169)	78.2 (2407)	75.4 (3267)	77.3 (1356)	53.0 (464)
Atypical	28.6 (3625)	38.9 (360)	25.7 (440)	31.5 (971)	28.8 (1250)	23.6 (414)	21.7 (190)
Typical	45.7 (5797)	43.1 (399)	42.5 (729)	46.6 (1436)	46.5 (2017)	53.7 (942)	31.3 (274)
Atypical monotherapy‡, % (n)	38.5 (3625)	47.4 (360)	37.6 (440)	40.3 (971)	38.3 (1250)	30.5 (414)	41.0 (190)
Amisulpiride§	5.5 (198)	0	1.6 (7)	18.6 (181)	0.2 (3)	1.7 (7)	0
Clozapine§	12.4 (450)	7.5 (27)	19.1 (84)	12.9 (125)	9.3 (116)	16.9 (70)	14.7 (28)
Olanzapine§	16.6 (601)	10.3 (37)	11.4 (50)	18.6 (181)	18.3 (229)	16.4 (68)	18.9 (36)
Quetiapine§	8.3 (302)	3.1 (11)	9.1 (40)	5.9 (57)	10.7 (134)	8.9 (37)	12.1 (23)
Risperidone§	55.1 (1997)	75.6 (272)	55.5 (244)	39.8 (386)	61.4 (767)	54.4 (225)	54.2 (103)
Other atypicals§	7.6 (275)	3.6 (13)	5.0 (22)	22.9 (222)	0.3 (4)	3.4 (14)	0.0 (0)
Typical monotherapy‡, % (n)	61.5 (5797)	52.6 (399)	62.4 (729)	59.7 (1436)	61.7 (2017)	69.5 (942)	59.1 (274)
Haloperidol¶	42.6 (2471)	34.1 (136)	18.7 (136)	31.7 (455)	61.3 (1237)	44.8 (422)	31.0 (85)
Combination therapy, % (n)	25.7 (3260)	17.9 (166)	31.8 (546)	21.8 (672)	24.6 (1067)	22.7 (398)	47.0 (411)
Atypical**	1.9 (62)	3.0 (5)	2.8 (15)	3.0 (20)	1.3 (14)	1.8 (7)	0.2 (1)
Typical**	63.7 (2078)	59.6 (99)	60.3 (329)	61.8 (415)	60.0 (640)	71.6 (285)	75.4 (310)
Atypical + Typicals**	34.4 (1120)	37.4 (62)	37.0 (202)	35.3 (237)	38.7 (413)	26.6 (106)	24.3 (100)
Concomitant
Medications, % (n)	73.6 (9331)	88.2 (816)	67.3 (1154)	58.4 (1799)	80.4 (3482)	84.0 (1474)	69.3 (606)
Anticholinergics	40.4 (5125)	60.1 (556)	33.1 (568)	26.2 (805)	42.6 (1846)	49.7 (871)	54.7 (479)
Antidepressants	20.8 (2637)	17.0 (157)	24.1 (413)	24.0 (740)	19.5 (845)	20.0 (350)	15.1 (132)
Anxiolytics/Hypnotics	42.5 (5386)	57.3 (530)	39.9 (684)	26.3 (811)	54.4 (2355)	49.5 (869)	15.7 (137)
Mood stabilisers	11.4 (1451)	12.9 (119)	7.1 (122)	8.3 (255)	12.2 (530)	19.9 (349)	8.7 (76)

*Describes the medications patients were taking immediately prior to study entry, upon presentation to the baseline visit. Patients who had never previously received an antipsychotic for schizophrenia were excluded. †Includes use both alone and in combination, such that patients may be counted in more than one category (e.g., a patient on both typical and atypical oral will be counted in each category), so the sum of the percentages does not equal 100%. ‡Expressed as a proportion of patients on antipsychotic monotherapy only (excludes patients receiving polypharmacy). §Expressed as a proportion of patients on atypical antipsychotic monotherapy only (denominator is 3625). ¶Expressed as a proportion of patients on typical antipsychotic monotherapy only (denominator is 5797). **Expressed as a proportion of patients on antipsychotic combination therapy only (excludes patients on monotherapy).