Preventive treatment patterns and treatment satisfaction in migraine: results of the OVERCOME (EU) study.

BACKGROUND: Insights into the burden, needs and treatment of migraine from internet-based surveys in diverse real-world migraine populations are needed, especially at a time when novel preventive migraine medications are becoming part of the therapeutic armamentarium. The objectives of this analysis are to describe traditional preventive (orals and onabotulinum toxin A) treatment patterns in the OVERCOME (EU) study migraine cohort, as well as treatment patterns and patient satisfaction with current treatment in a subgroup of respondents eligible for migraine preventive medication. METHODS: The cross-sectional non-interventional OVERCOME (EU) study was conducted (October 2020-February 2021) via an online survey among adults (aged ≥ 18 years) resident in Germany or Spain. Participants, registered in existing online panels, who were willing to provide consent were considered. The migraine cohort included participants reporting headache/migraine in the past year, identified based on a validated migraine diagnostic questionnaire and/or self-reported physician diagnosis. A subgroup of survey respondents defined as eligible for migraine preventive medication at the point in time the cross-sectional survey was taken was also analysed. Variables assessed included sociodemographic and migraine-related clinical characteristics, preventive (traditional and calcitonin gene-related peptide monoclonal antibodies) treatment patterns and patient satisfaction with current treatment. Results are descriptive only. RESULTS: Of the 20,756 participants in the migraine cohort, 78.5% sought professional medical care, 50.8% received a migraine diagnosis and only 17.7% had ever used preventive medication. Half (53.3%) of participants currently using preventives took their most recent medication for six months or less. Most patients (73.9%) classified as eligible for preventive medication (based on headache frequency and/or at least moderate disability due to migraine) reported not using traditional preventives and many of those who did (66.8%) were not satisfied with their current standard of care. CONCLUSIONS: Our findings highlight the low proportion of people diagnosed with migraine despite a higher rate of consultation and suggest the need for better access to treatment for people with migraine and new preventive therapies with improved efficacy and safety profiles to improve adherence and patient satisfaction.

A systematic literature review of prognostic factors in patients with HR+/HER2- advanced breast cancer in Japan.

BACKGROUND: Breast cancer is the most prevalent cancer in women in Japan and the fifth in mortality. This systematic review summarized the evidence for prognostic factors for patients with HR+/HER2- advanced and metastatic breast cancer in Japan. METHODS: MEDLINE and EMBASE were searched with keywords 'breast neoplasms' AND 'Japan' AND 'advanced' or equivalent, and Japan Medical Abstract Society database with 'breast cancer' AND 'advanced/metastatic' for publications from January 2010 to October 2019. ASCO, ESMO, ABC4 abstracts and WHO website were hand searched. The endpoints of interest were overall survival, progression-free survival, tumour response and post-progression survival. Factors were evaluated based on the consistency in direction and the strength (hazard ratios) of association. RESULTS: Searches identified 4530 publications, of which 27 were eligible. All were observational studies. Among the endpoints, overall survival was the most commonly assessed (n = 22) and evaluated further. Ki-67 expression, progesterone receptor expression status, tumour grade and lymph node metastases were consistently associated with poor overall survival in univariate analysis but not in multivariate analysis. Short disease-free interval, the number of metastatic organs and liver metastasis were consistently associated with poor overall survival in both of univariate and multivariate analysis. The association was strong for liver metastasis (hazard ratio ≥2.8 in the majority of studies) and moderate for disease-free interval and the number of metastatic organs (hazard ratio 1.3-2.8 in the majority of studies). CONCLUSIONS: Disease-free interval, the number of metastatic organs and liver metastasis were identified as independent prognostic factors for overall survival. These findings may help clinical decision-making to improve outcomes in patients with HR+/HER2- advanced and metastatic breast cancer.

Real-world Effectiveness of Antipsychotics for the Treatment of Negative Symptoms in Patients with Schizophrenia with Predominantly Negative Symptoms.

This study assessed the comparative effectiveness of antipsychotics in the treatment of patients with schizophrenia presenting with prominent negative symptoms and no-to-mild positive symptoms. Data were taken from a 3-year prospective, international, observational study (n=17 384). This post-hoc study focused on 3 712 patients who started antipsychotic monotherapy and had moderate-to-severe negative symptoms and no-to-mild positive symptoms (Clinical Global Impression-Severity Scale [GGI-SCH]). Patients were classified into 3 treatment cohorts: olanzapine, other atypicals and typicals. Multiple regression analyses were performed. All treatment groups experienced improvement in negative symptoms and social functioning during follow-up. The adjusted mean change in the CGI-SCH negative symptoms scores during follow-up was greater for olanzapine-treated patients by 0.220 (p<0.001) (vs. other atypicals) and by 0.453 (p<0.001) (vs. typicals). Olanzapine-treated patients were also most likely to achieve response of negative symptoms and improvement in social functioning, and to stay on the initial medication longer. Patients with schizophrenia treated with antipsychotics experienced improvement in negative symptoms and social functioning during follow-up. Olanzapine appeared to be more effective compared with other antipsychotics.

The economic burden of advanced gastric cancer in Taiwan.

BACKGROUND: Gastric cancer is one of the leading causes of cancer-related deaths in both sexes worldwide, especially in Eastern Asia. This study aimed to estimate the economic burden of advanced gastric cancer (AGC) in Taiwan. METHODS: The costs of AGC in 2013 were estimated using resource use data from a chart review study (n = 122 with AGC) and national statistics. Annual per-patient costs, where patients' follow-up periods were adjusted for, were estimated with 82 patients who had complete resource use data. The costs were composed of direct medical costs, direct non-medical costs (healthcare travel and caregiver costs), morbidity costs, and mortality costs. Relevant unit costs were retrieved mainly from literature and national statistics, and applied to the resource use data. A broad definition of morbidity and mortality costs was employed to value the productivity loss in patients with unpaid employment, economically inactive and unemployed as well as the life years after the age of retirement. Their narrow definitions were also used in sensitivity analyses, using age- and/or sex-specific employment rates. Forgone future earnings/productivity loss were discounted at 3%. Annual per-patient costs were projected to estimate the total costs of AGC at the national level with an estimated number of patients with AGC (N = 2611) in Taiwan in 2013. RESULTS: The mean age of the 82 patients was 59.3 (SD: 11.9) years, and 67.1% were male. Per-patient costs were US$26,431 for direct medical costs, US$4669 for direct non-medical costs, US$5758 for morbidity costs, and US$145,990 for mortality costs (per death). These per-patient costs were projected to incur total AGC costs of US$423 million at the national-level. Mortality costs accounted for 77.3% of the total costs, followed by direct medical costs (16.3%), morbidity costs (3.6%), and direct non-medical costs (2.9%). CONCLUSION: AGC was found to exert a significant economic burden in Taiwan, incurring US$423 million in 2013. This represents about 0.08% of the Taiwanese economy. Mortality costs appeared to be the single greatest contributor to the burden, followed by direct medical costs. Early detection and providing effective treatments will help to reduce its burden on patients, caregivers and society as a whole. A poster of this study was presented at the 2016 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, CA, USA.

Functional Impairment and Painful Physical Symptoms in Patients with Major Depressive Disorder Treated with Antidepressants: Real-World Evidence from the Middle East.

BACKGROUND: The Global Burden of Disease 2010 study reported the relative size of major depressive disorder (MDD) burden to be greater in the Middle East and North Africa than anywhere else. However, little research has been carried out to examine the comparative effectiveness of antidepressants in this region. OBJECTIVE: To assess and compare functioning levels in Middle Eastern patients with MDD treated with either duloxetine or a selective serotonin reuptake inhibitor (SSRI), and to examine the impacts of depression-related pain on functioning by the type of treatment. METHOD: This post-hoc analysis, which focused on Middle Eastern patients, used data from a 6-month prospective observational study that included 1,549 MDD patients without sexual dysfunction. Levels of functional impairment and depression-related pain were assessed using the Sheehan Disability Scale (SDS) and the modified Somatic Symptom Inventory, respectively. A mixed model with repeated measures (MMRM) was employed. RESULTS: The mean age of the patients was 37.3 (SD=8.4) years, and 34.6% were female. Patient functioning was, on average, moderately impaired at baseline, but improved substantially during follow-up in both the duloxetine (n=152) and the SSRI (n=123) cohorts. The MMRM results showed a lower level of functional impairment at 24 weeks in the duloxetine cohort than in the SSRI cohort (p<0.001). Pain severity at baseline was positively associated with functional impairment during follow-up only in the SSRI cohort (p=0.003). CONCLUSION: Duloxetine-treated MDD patients achieved better functioning than SSRI-treated patients. This treatment difference was partly driven by depression-related pain.

Factors associated with and impact of pain persistence in Asian patients with depression: a 3-month, prospective observational study.

OBJECTIVE: We investigated the depression outcomes and the factors associated with pain persistence in Asian patients treated for major depressive disorder (MDD). METHODS: This observational study enrolled 909 Asian adult inpatients and outpatients. The presence or absence of painful physical symptoms and severity of depression were assessed at baseline and after three months of treatment. Factors associated with pain persistence and outcome of depression were investigated using regression methods. RESULTS: Of the 909 patients enrolled, 684 were included in the analysis and evaluated at three months. Of them, 335 (49%) had no pain at baseline nor follow up, 198 (29%) at baseline but not at follow up and 151 (22%) in both assessments. Pain more frequently persisted in patients who were divorced/widowed/separated, with >1 comorbidity, aged <40 years, with previous MDD episodes, taking pain medications, and with greater depression severity. At three months, response/remission were 84%/73% in the no pain group, 83%/63% in the remitted pain group and 46%/25% in the persistent pain group (differences all p < .0001; all bivariate comparisons were statistically significant with p < .05 except response between no pain and remitted pain). Persistent pain was also associated with less improvement in quality of life and health state. CONCLUSIONS: Pain should be taken into account when diagnosing MDD and when tailoring therapy.

Caregiving for patients with Alzheimer's disease or dementia and its association with psychiatric and clinical comorbidities and other health outcomes in Brazil.

OBJECTIVES: Individuals with dementia due to Alzheimer's disease often receive care from family members who experience associated burden. This study provides the first broad, population-based account of caregiving-related health outcome burden in Brazil. METHODS: Data were analyzed from the 2012 National Health and Wellness Survey in Brazil (n = 12,000), an Internet-based survey of adults (aged 18+ years), using stratified sampling by sex and age to ensure demographic representation of Brazil's adult population. Caregivers of individuals with Alzheimer's disease or dementia were compared with non-caregivers on comorbidities, productivity impairment, health-related quality of life, resource utilization, sociodemographic/health characteristics and behaviors, and Charlson comorbidity index scores. Regression models assessed outcomes associated with caregiving, adjusting for potential confounds. RESULTS: Among 10,853 respondents, caregivers' (n = 209) average age was 42.1 years, 53% were female, and 52% were married/living with a partner. Caregivers versus non-caregivers (n = 10,644) were more frequently obese, smokers, insured, employed, college-educated, and wealthier and had higher Charlson comorbidity index, all p < 0.05. Adjusting for covariates, caregiving was associated with significantly increased risk of depressive symptoms (odds ratio [OR] = 2.008), major depressive disorder (OR = 1.483), anxiety (OR = 1.714), insomnia (OR = 1.644), hypertension (OR = 1.584), pain (OR = 1.704), and diabetes (OR = 2.103), all p < 0.015. Caregiving was also associated with lower health utilities (-0.024 points) and mental health status (-1.70 points), higher rates of presenteeism-related impairment (32.7% greater) and overall work impairment (35.9% greater), and higher traditional provider visit rates (28.7% greater), all p < 0.035. CONCLUSIONS: Caregiver status was found to be a factor associated with worse health outcomes and psychiatric and clinical disorders.

Relationship of insight with medication adherence and the impact on outcomes in patients with schizophrenia and bipolar disorder: results from a 1-year European outpatient observational study.

BACKGROUND: Many patients with schizophrenia and bipolar disorder have impaired insight and low medication adherence. The aim of this post hoc analysis was to explore the relationship between insight and medication adherence. METHODS: We included 903 patients with schizophrenia or bipolar disorder who participated in an observational study conducted in Europe on the outcomes of patients treated with two oral formulations of olanzapine over a 1-year period. Evaluations included Clinical Global Impression (CGI), Global Assessment of Functioning (GAF), insight (Scale to Assess Unawareness of Mental Disorder, SUMD) medication adherence (Medication Adherence Rating Scale, MARS), and therapeutic alliance (Working Alliance Inventory, WAI). RESULTS: Medication adherence was higher in bipolar patients (mean MARS score (SD) 6.5 (2.8) versus 5.8 (2.7) in schizophrenia; p < 0.001). Patients with schizophrenia had lower insight (i.e., SUMD item 1, unawareness of mental disorder, mean (SD) of 2.5 (1.3) in schizophrenia versus 1.9 (1.2) in bipolar, p < 0.001). Better insight was associated with higher adherence (Spearman Correlation Coefficient, SCC, ranging from 0.39 to 0.49 for the three SUMD general items, p < 0.0001 in all cases). Higher insight was related to a stronger therapeutic alliance (SCC ranging from 0.38 to 0.48, p < 0.0001). A path analysis revealed a positive impact of insight on adherence and alliance and that stronger alliance was related to lower clinical severity (lower CGI score). CONCLUSION: Insight and adherence were found to be closely related. Insight impacts on the therapeutic alliance with mental health professionals. These factors are associated to treatment outcomes.

Should Unexplained Painful Physical Symptoms be Considered within the Spectrum of Depressive Symptoms?

OBJECTIVE: To examine whether painful physical symptoms (PPS) can be considered within the spectrum of depressive symptoms. METHODS: Data for this post-hoc analysis were taken from a 6-month observational study mostly conducted in East Asia, Mexico, and the Middle East of 1,549 depressed patients without sexual dysfunction at baseline. Both explanatory and confirmatory factor analyses (EFA and CFA) were performed on the combined items of the 16-item Quick Inventory of Depressive Symptomatology Self-Report and the Somatic Symptom Inventory (seven pain-related items only). An additional second-order CFA was also conducted to examine an association between retained factors and the overall "depressive symptoms" factor. In addition, Spearman's correlation was used to assess levels of correlation between retained factors and depression severity as well as quality of life. RESULTS: Both EFA and CFA suggested and validated a four-factor solution, which included a pain factor. The other three factors identified were a mood/cognitive factor, a sleep disturbance factor, and an appetite/weight disturbance factor. All four factors were significantly associated with the overall factor of depression. They were also highly correlated to depression severity and quality of life (p<0.001 for all). The levels of correlations with the pain factor were generally greater than those with the appetite/weight factor and similar to those with the sleep factor. CONCLUSION: It may be reasonable to consider PPS within a broad spectrum of depressive symptoms. At least, they should be routinely assessed in patients with depression. Further research is warranted to validate these preliminary findings.

Chinese patients with major depression: Do concomitant pain symptoms affect quality of life independently of severity of depression?

OBJECTIVE: This study investigated whether painful physical symptoms (PPSs) influenced quality of life (QoL) when adjusting for severity of depression. METHODS: Severity of depression, QoL and PPSs were assessed at baseline and 3 months among the Chinese cohort (n = 300) of a 3-month observational study of major depressive disorder (MDD) in East Asia. The presence of PPS was defined as 'a mean score of ≥2 on the Somatic Symptom Inventory pain-related items'. Regression analyses determined predictors of QoL at 3 months, adjusting for age, sex, depressive symptoms, overall severity and QoL at baseline. RESULTS: PPSs were present (PPS+) at baseline in 35.3% of patients. Over 3 months, in the whole sample, EuroQoL visual analogue scale (EQ-VAS) score improved from 45.5 (standard deviation [SD]: 20.9) to 81 (SD: 16.7), and EuroQoL 5-Dimension Questionnaire (EQ-5D) score improved from 0.52 (SD: 0.31) to 0.89 (0.16). At 3 months, mean EQ-VAS was 75.9 (SD: 17.7) for PPS+ versus 83.7 (SD: 15.6) for PPS-, and mean EQ-5D was 0.83 (SD: 0.17) versus 0.92 (SD: 0.14). PPS+ at baseline was a significant predictor of QoL at 3 months after adjusting for socio-demographic and baseline clinical variables. CONCLUSIONS: PPSs were associated with less improvement in QoL in patients receiving treatment for MDD, independent of severity of depression.

Patient characteristics associated with treatment initiation among paediatric patients with Attention-Deficit/Hyperactivity Disorder symptoms in a naturalistic setting in Central Europe and East Asia.

BACKGROUND: Cultural views of Attention-Deficit/Hyperactivity Disorder (ADHD), differing healthcare systems and funding mechanisms, and the availability of mental health services can greatly influence the perceptions, diagnosis, and treatment of ADHD. There is, however, lack of information about treatment practice and the treatment decision-making process for ADHD, particularly in non-Western countries. Our study compared characteristics of paediatric patients newly diagnosed with ADHD symptoms who did and who did not initiate treatment, and also examined whether any differences varied by region in Central Europe and East Asia. METHODS: Data were taken from a 1-year prospective, observational study that included 1,068 paediatric patients newly diagnosed with ADHD symptoms. Clinical severity was measured using the Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) scale and the Child Symptom Inventory-4 (CSI-4) checklist. Logistic regression was used to explore patient characteristics associated with treatment initiation (pharmacotherapy and/or psychotherapy) at baseline for each region. RESULTS: A total of 74.3% of patients initiated treatment at baseline (78.3% in Central Europe and 69.9% in East Asia). Of these, 48.8% started with both pharmacotherapy and psychotherapy in Central Europe, and only 17.1% did so in East Asia. The level of clinical severity was highest in the combination treatment group in Central Europe, but was highest in the psychotherapy only group in East Asia. In East Asia, treatment initiation was associated with being older, being male, and having a higher CGI-ADHD-S score. In Central Europe, treatment initiation was associated with parental psychological distress, having a higher CSI-4 score, and not being involved in bullying. CONCLUSIONS: Although factors associated with treatment initiation differed to some extent between Central Europe and East Asia, clinical severity appeared to be one of the most important determinants of treatment initiation in both regions. However, the choice between pharmacotherapy and psychotherapy, either alone or in combination, varied substantially across the regions.

Impact of painful physical symptoms on depression outcomes in elderly Asian patients.

ABSTRACT Background: Painful physical symptoms (PPS) are prevalent among elderly patients with depression. We describe the impact of PPS on depression outcomes and quality of life (QOL) of elderly Asian patients with major depressive disorder (MDD). Methods: This post hoc analysis of data from a three-month prospective observational study of East Asian MDD in- or out-patients focused on elderly patients aged ≥60 years. Depression severity was evaluated using the Hamilton depression (HAMD-17) and clinical global impression of severity (CGI-S) scales, while QOL was measured using EuroQOL (EQ-5D and EQ-VAS) instruments. PPS were rated using the modified somatic symptom inventory (SSI). Results: At baseline, depression was moderate to severe and 49% of the 146 elderly patients were painful physical symptom positive (PPS+). Bivariate analysis showed significant correlations between PPS and depression severity and QOL at baseline. Linear regression models showed the baseline factor most significantly associated with depression severity at three months was baseline PPS status. PPS+ patients had a mean increase of 2.87 points in their HAMD-17 rating and 0.77 points in their CGI-S score. Response and remission were significantly lower in PPS+ patients; response was 60% and remission was 40% in PPS+ patients while 82% and 66% in painful physical symptom negative (PPS-) patients. QOL at endpoint was lower in PPS+ patients. Conclusions: PPS are common in elderly Asian patients with MDD and negatively influence depression outcomes and QOL. Patients with PPS had lower QOL at baseline, lower response and remission rates, higher severity of depression, and lower QOL after three months of treatment.

Direct medical costs and medication compliance among fibromyalgia patients: duloxetine initiators vs. pregabalin initiators.

OBJECTIVES: To assess and compare direct medical costs and medication compliance between patients with fibromyalgia who initiated duloxetine and patients with fibromyalgia who initiated pregabalin in 2008. METHODS: A retrospective cohort study design was used based on a large US national commercial claims database (2006 to 2009). Patients with fibromyalgia aged 18 to 64 who initiated duloxetine or pregabalin in 2008 and who had continuous health insurance 1 year preceding and 1 year following the initiation were selected into duloxetine cohort or pregabalin cohort based on their initiated agent. Medication compliance was measured by total supply days, medication possession ratio (MPR), and proportion of patients with MPR ≥ 0.8. Direct medical costs were measured by annual costs per patient and compared between the cohorts in the year following the initiation. Propensity score stratification and bootstrapping methods were used to adjust for distribution bias, as well as cross-cohort differences in demographic, clinical and economic characteristics, and medication history prior to the initiation. RESULTS: Both the duloxetine (n = 3,033) and pregabalin (n = 4,838) cohorts had a mean initiation age around 49 years, 89% were women. During the postindex year, compared to the pregabalin cohort, the duloxetine cohort had higher totally annual supply days (273.5 vs. 176.6, P < 0.05), higher MPR (0.7 vs. 0.5, P < 0.05), and more patients with MPR ≥ 0.8 (45.1% vs. 29.4%, P < 0.05). Further, relative to pregabalin cohort, duloxetine cohort had lower inpatient costs ($2,994.9 vs. $4,949.6, P < 0.05), lower outpatient costs ($8,259.6 vs. $10,312.2, P < 0.05), similar medication costs ($5,214.6 vs. $5,290.8, P > 0.05), and lower total medical costs ($16,469.1 vs. $20,552.6, P < 0.05) in the postinitiation year. CONCLUSIONS: In a real-world setting, patients with fibromyalgia who initiated duloxetine in 2008 had better medication compliance and consumed less inpatient, outpatient, and total medical costs than those who initiated pregabalin.

Acute Treatment Patterns, Migraine Burden, and Healthcare Resource Use in People With Migraine: Results From the OVERCOME (EU) Observational Study.

INTRODUCTION: The ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE (OVERCOME) European Union (EU) is part of an overarching population-based study program that also includes the United States and Japan. Here, we report data on the migraine/severe headache burden and the use of acute medication and healthcare resources in Spain and Germany. METHODS: OVERCOME (EU) was an online, non-interventional, cross-sectional survey conducted in adults in Spain and Germany between October 2020 and February 2021. A total migraine cohort was established based on health survey participants who reported headache/migraine in the last 12 months AND identified as having migraine based on modified International Classification of Headache Disorders, third edition criteria OR self-reported physician diagnosis. Data were analyzed for the total migraine cohort and the subcohort with moderate to severe headache attacks, with average pain severity ≥ 5 points, pain duration ≥ 4 h, and at least moderate disability due to migraine [Migraine Disability Assessment (MIDAS) score ≥ 11] over the past 3 months. RESULTS: Pain of moderate or severe intensity was the most frequent symptom in the total migraine cohort (n = 19,103/20,756; 92.0%). Proportions of participants reporting severe disability (MIDAS Grade IV), poorer quality of life (QoL; Migraine-Specific QoL Questionnaire), and higher interictal burden (Migraine Interictal Burden Scale-4), generally increased with number of headache days (HDs)/month. Most participants (92.5%) reported current acute migraine/severe headache medication use, although only 39.0% were using triptans. In the moderate to severe attacks subcohort (n = 5547), 48.4% were using triptans, with nonsteroidal anti-inflammatory drugs the most common acute medication. The moderate to severe attacks subcohort also reported poorer QoL and greater pain and disability with increasing HDs/month, although severe interictal burden was reported for ~ 60% of participants regardless of HDs/month. Treatment satisfaction (six-item migraine Treatment Optimization Questionnaire) in those using triptans was generally poor in both total and subcohorts. CONCLUSION: High migraine-related burden levels were reported, despite use of acute medication. Although triptans are recommended for moderate to severe migraine attacks in Spanish and German guidelines, less than half of participants were using triptans; treatment satisfaction in those using triptans was generally poor. New tailored treatment options may help address unmet needs in current acute treatment.

Empirically driven definitions of "good," "moderate," and "poor" levels of functioning in the treatment of schizophrenia.

PURPOSE: This study used an empirical approach to identify and validate the classification of patients with schizophrenia in "good," "moderate," or "poor" functioning groups based on the assessment of functional measures. METHODS: Using data from a study of schizophrenia outpatients, patients were classified into functional groups using cluster analysis based on the Heinrich-Carpenter Quality of Life Scale (QLS), the 36-item Short-Form Health Survey (SF-36) Mental Component Summary Score, and a productivity measure. A three-cluster solution was chosen. Concurrent, convergent, and discriminant validity were assessed. Criteria for classifying patient functioning as "good," "moderate," or "poor" were established using classification and regression tree analysis. RESULTS: The three clusters consistently differentiated patients on the QLS, SF-36 Mental Component Summary Score, and productivity measure. The clusters also differed on other functional measures and were concordant with previous functional classifications. Concurrent, convergent, and discriminant validity were good. "Good" functioning was identified as a QLS total score ≥ 84.5; "moderate" and "poor" functioning were separated by a cutoff score of 15.5 on the QLS intrapsychic foundation domain. Sensitivity ranged from 86 to 93 % and specificity from 89 to 99 %. CONCLUSIONS: The heterogeneity in functioning of schizophrenia patients can be classified reliably in an empirical manner using specific cutoff scores on commonly used functional measures.

Predictors of psychiatric hospitalization during 6 months of maintenance treatment with olanzapine long-acting injection: post hoc analysis of a randomized, double-blind study.

BACKGROUND: Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of psychiatric hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assessed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. METHODS: This was a post hoc exploratory analysis of data from a randomized, double-blind study comparing the safety and efficacy of olanzapine-LAI (pooled active depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 mg/4 weeks) during 6 months' maintenance treatment of clinically stable schizophrenia outpatients (n=1064). The four psychiatric hospitalization parameters were analyzed for each treatment group. Within the olanzapine-LAI group, patients with and without hospitalization were compared on baseline characteristics. Logistic regression and Cox's proportional hazards models were used to identify the best predictors of hospitalization. Comparisons between the treatment groups employed descriptive statistics, the Kaplan-Meier estimator and Cox's proportional hazards models. RESULTS: Psychiatric hospitalization was best predicted by suicide threats in the 12 months before baseline and by prior hospitalization. Compared with sub-therapeutic olanzapine-LAI, olanzapine-LAI was associated with a significantly lower hospitalization rate (5.2% versus 11.1%, p < 0.01), a lower mean number of hospitalizations (0.1 versus 0.2, p = 0.01), a shorter mean duration of hospitalization (1.5 days versus 2.9 days, p < 0.01), and a similar median time to first hospitalization (35 versus 60 days, p = 0.48). Olanzapine-LAI did not differ significantly from oral olanzapine on the studied hospitalization parameters. CONCLUSIONS: In clinically stable schizophrenia outpatients receiving olanzapine-LAI maintenance treatment, psychiatric hospitalization was best predicted by a history of suicide threats and prior psychiatric hospitalization. Olanzapine-LAI was associated with a significantly lower incidence of psychiatric hospitalization and shorter duration of hospitalization compared with sub-therapeutic olanzapine-LAI. Olanzapine-LAI did not differ significantly from oral olanzapine on hospitalization parameters. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00088491.

Changes in adherence and treatment costs following initiation of oral or depot typical antipsychotics among previously non-adherent patients with schizophrenia.

OBJECTIVE: This study assessed the impact of depot formulations on adherence and treating costs in the naturalistic treatment of previously non-adherent outpatients with schizophrenia. METHODS: Data were taken from the European Schizophrenia Outpatient Health Outcomes (SOHO) study. Medication adherence and treating costs during an 18-month follow-up were assessed and compared for non-adherent patients initiated on depot typical (n = 262) or oral typical antipsychotics (n = 169) as monotherapy at the index visit. Multivariate analyses were employed to adjust for differences between the two groups at the index visit. RESULTS: Of the previously non-adherent patients, more than half of patients initiated on depot typicals (55%) remained adherent to medication during follow-up, whereas the equivalent was 39% for patients initiated on oral typicals. Logistic regression also showed higher odds of being adherent among the former group (Odds ratio = 1.84; 95% CI = 1.19-2.85). In addition, total costs incurred by this group during 18 months were only half those incurred by patients initiated on oral typicals (£3645 vs £7817, p < 0.05) CONCLUSIONS: Depot formulations of typical antipsychotics appeared to improve medication adherence and reduce treatment costs, compared with oral formulations, in the treatment of non-adherent patients. LIMITATION: adherence was assessed by the treating psychiatrist using a single-item.

Factors predicting hostility in outpatients with schizophrenia: 36-month results from the SOHO study.

This analysis explored the prevalence, incidence, and predictors of hostility in the European Schizophrenia Outpatient Health Outcomes (EU-SOHO) study. Data were collected at baseline and up to 36 months on the presence of hostility, clinical course and severity, medication compliance, side effects, substance/alcohol abuse, and being a crime survivor. Regression models were fitted to test the association between predictors and the presence of hostility. Hostility prevalence in the 6 months before baseline was 27.9%, and the incidence at 3 years was 14.0%. Variables related to hostility during follow-up were age, male sex, alcohol/substance abuse, tardive dyskinesia, extrapyramidal symptoms, cognitive impairment, noncompliance, and hospitalization. Being a crime survivor, being married, not living independently, and not being in paid employment were associated with hostility at baseline. Clinical and social variables are related to hostility in schizophrenia. Extrapyramidal symptoms and tardive dyskinesia, alcohol/substance abuse, cognitive impairment, medication noncompliance, and hospitalizations are predictors of future hostility.

Treatment Patterns and Health Resource Utilization in Patients With HR+/ HER2- Locally Advanced or Metastatic Breast Cancer in a Real-World Setting in Taiwan.

OBJECTIVES: This study aimed to understand current treatment patterns and healthcare resource utilization (HRU) of women with locally advanced or metastatic breast cancer (advanced breast cancer [ABC]) in Taiwan overall and within the subgroup of patients who were postmenopausal women with no previous systemic therapy in the ABC setting. METHODS: A chart review of anonymized data on patient characteristics, treatment patterns, and HRU was conducted via an online physician survey including 118 patient charts from women ≥ 18 years old with hormone receptor positive/human epidermal growth receptor negative ABC, diagnosed between 2015 and 2017. RESULTS: The mean age of all patients was 56.6 years (range 29-83). Among the 118 patients, the most common first-line systemic therapy group after diagnosis of ABC was endocrine-based therapy (39.0%) or endocrine therapy (ET) plus chemotherapy (ChT) combinations (38.1%). In the postmenopausal subgroup (n = 56), ET-based therapy was the most common (44.6%). Oncologist visits, at annual rate of 9.20 (95% confidence interval 8.81-9.60), and hospitalizations, at annual rate of 1.08 (95% confidence interval 0.96-1.22), were key drivers of HRU. Of the 118 patients, the 72 with at least one ChT agent in their first-line regimen had an annual hospitalization rate of 1.4 versus 0.45 admissions compared with the 46 patients on first-line ET-based therapy. CONCLUSIONS: Current treatment patterns suggest an unmet need for new medications that lead to reduction in high rate of ChT use. Results can inform future evaluations of new ABC treatments that estimate the health economic impact of their adoption in Taiwan.