Psychometric Assessment of an Item Bank for Adaptive Testing on Patient-Reported Experience of Care Environment for Severe Mental Illness: Validation Study.

BACKGROUND: The care environment significantly influences the experiences of patients with severe mental illness and the quality of their care. While a welcoming and stimulating environment enhances patient satisfaction and health outcomes, psychiatric facilities often prioritize staff workflow over patient needs. Addressing these challenges is crucial to improving patient experiences and outcomes in mental health care. OBJECTIVE: This study is part of the Patient-Reported Experience Measure for Improving Quality of Care in Mental Health (PREMIUM) project and aims to establish an item bank (PREMIUM-CE) and to develop computerized adaptive tests (CATs) to measure the experience of the care environment of adult patients with schizophrenia, bipolar disorder, or major depressive disorder. METHODS: We performed psychometric analyses including assessments of item response theory (IRT) model assumptions, IRT model fit, differential item functioning (DIF), item bank validity, and CAT simulations. RESULTS: In this multicenter cross-sectional study, 498 patients were recruited from outpatient and inpatient settings. The final PREMIUM-CE 13-item bank was sufficiently unidimensional (root mean square error of approximation=0.082, 95% CI 0.067-0.097; comparative fit index=0.974; Tucker-Lewis index=0.968) and showed an adequate fit to the IRT model (infit mean square statistic ranging between 0.7 and 1.0). DIF analysis revealed no item biases according to gender, health care settings, diagnosis, or mode of study participation. PREMIUM-CE scores correlated strongly with satisfaction measures (r=0.69-0.78; P<.001) and weakly with quality-of-life measures (r=0.11-0.21; P<.001). CAT simulations showed a strong correlation (r=0.98) between CAT scores and those of the full item bank, and around 79.5% (396/498) of the participants obtained a reliable score with the administration of an average of 7 items. CONCLUSIONS: The PREMIUM-CE item bank and its CAT version have shown excellent psychometric properties, making them reliable measures for evaluating the patient experience of the care environment among adults with severe mental illness in both outpatient and inpatient settings. These measures are a valuable addition to the existing landscape of patient experience assessment, capturing what truly matters to patients and enhancing the understanding of their care experiences. TRIAL REGISTRATION: ClinicalTrials.gov NCT02491866; https://clinicaltrials.gov/study/NCT02491866.

Neuropsychological assessment fails to predict relapse among cigarette smokers: A prospective study of neurocognitive abilities.

OBJECTIVES: Understanding the factors that lead to relapse is a major challenge for the clinical support of smoking cessation. Neurocognitive abilities such as attention, executive functioning and working memory, are possible predictors of relapse and can be easily assessed in everyday clinical practice. In this prospective longitudinal study, we investigated the relationship between pre-smoking cessation neurocognitive performance and relapse at six months in a sample of patients being treated for their tobacco dependence. METHODS: 130 tobacco consumers were included in the study. They completed a comprehensive neuropsychological and clinical assessment before smoking cessation. The targeted abilities were intelligence, inhibition, shifting, working memory updating, verbal fluency and decision-making. RESULTS: The rate of tobacco relapse at 6 months was 58%. Logistic regressions were used to assess which variables best explained relapse. None of the neuropsychological tests was a significant predictor of relapse at either 1, 3 or 6 months, either alone, or controlling for other covariates acting as significant predictors of relapse. CONCLUSIONS: Common neuropsychological tests, even those specifically targeting executive functioning such as inhibition, are not useful predictors of the success of a smoking cessation program in a clinical setting. Other variables, such as motivation to quit smoking or the presence of comorbid depression or anxiety disorders, appear to be more useful predictors of relapse.

Reducing Health Inequalities in Individuals with Severe Mental Disorders: Harnessing Real-World Data and Patient-Reported Measures.

Mental disorders are the leading cause of diminished lifespans worldwide and make up 5 of the top 10 most significant causes of disability [...].

Direct medical cost of bipolar disorder: Insights from the FACE-BD longitudinal cohort.

BACKGROUND: Bipolar disorder (BD) is a severe chronic psychiatric disorder affecting 0.5 to 1% of the population worldwide. To date, most studies have estimated the cost of BD via information sourced from insurance claims with limited information on clinical characteristics and course of BD. The aims of this study are (i) to estimate the direct healthcare cost associated with BD and to identify contributing factors and (ii) to study the evolution of cost during a two-year follow-up period. METHOD: We analyzed a sample of 1116 individuals with BD included in the Advanced Centers of Expertise in Bipolar Disorder cohort. We estimated the direct healthcare cost per year and per patient, and we identified the clinical features of patients with BD associated with higher direct healthcare costs. In a subsample of patients followed up for two years centers of expertise for BD, we studied the evolution of direct healthcare cost. RESULTS: The average cost of bipolar disorder was € 6910 per year and per patient. Clinical features of BD, sociodemographic characteristics, and associated addiction were associated with higher direct healthcare costs. In the subsample of patients followed-up for two years, direct healthcare cost dropped by more than 50%, strongly suggesting the beneficial effect of specialized care organization. LIMITATION: We did not estimate indirect healthcare and intangible costs. CONCLUSION: Our study investigates the cost of BD and its evolution in a deeply phenotyped longitudinal sample. Cost-utility and cost-effectiveness analyses are required to inform resource allocation decisions and to promote innovative healthcare organizations.

Pregnancy, delivery and neonatal complications in women with schizophrenia: a national population-based cohort study.

BACKGROUND: Existing studies evaluating the association between schizophrenia and complications associated with pregnancy, delivery and neonatal outcomes are based on data prior to 2014 and have reported heterogeneous results. The objective of our study was to determine whether pregnant women with schizophrenia were at increased risk of pregnancy, delivery and neonatal complications compared with women without severe mental disorders. METHODS: We performed a population-based cohort study of all singleton deliveries in France between Jan. 1, 2015, and Dec. 31, 2019. We divided this population into cases (i.e., women with schizophrenia) and controls (i.e., women without a diagnosis of severe mental disorder). Cases and controls were matched (1:4) inside the same hospital and the same year by age, social deprivation, parity, smoking, alcohol and substance addictions, malnutrition, obesity, and comorbidities. Univariate and multivariate models with odds ratios and 95% confidence intervals (ORs [95% CIs]) were used to estimate the association between schizophrenia and 24 pregnancy, delivery and neonatal outcomes. FINDINGS: Over 5 years, 3,667,461 singleton deliveries were identified, of which 3,108 occurred in women with schizophrenia. Compared to controls, women with schizophrenia were found to be older; have more frequent smoking, alcohol and substance addictions; suffer from obesity, diabetes and chronic obstructive pulmonary disease; and often be hospitalized in tertiary maternity hospitals. Compared to matched controls, women with schizophrenia had more pregnancy complications (adjusted OR=1.41[95%CI 1.31-1.51]) (i.e., gestational diabetes, gestational hypertension, genito-urinary infection, intrauterine growth retardation and threatened preterm labour). They had more delivery complications (aOR=1.18[95%CI 1.09 1.29]) with more still births/medical abortions (aOR=2.17[95%CI 1.62-2.90]) and caesarean sections (aOR=1.15[95%CI 1.05-1.25]). Newborns of women with schizophrenia had more neonatal complications (aOR=1.38[95%CI 1.27-1.50]) with more born preterm (aOR=1.64[95%CI1.42 -1.90]), small for gestational age (aOR=1.34[95%CI 1.19-1.50]) and low birth weight (aOR=1.75[95%CI 1.53-2.00]). INTERPRETATION: Our results highlight the importance of health disparities between pregnant women with and without schizophrenia, as well as in their newborns. Our study calls for health policy interventions during and before pregnancy, including proportionate intensified care to the level of needs, effective case management and preventive and social determinant approaches. FUNDING: No funding.

[Mortality in schizophrenia: Towards a new health scandal? COVID-19 and schizophrenia]. / Mortalité dans la schizophrénie : vers un nouveau scandale sanitaire ? COVID-19 et schizophrénie.

Patients with schizophrenia represent a vulnerable population who have been understudied in COVID-19 research. We aimed to establish whether health outcomes and care differed between patients with schizophrenia and patients without a diagnosis of severe mental illness. We conducted a population-based cohort study of all patients with identified COVID-19 and respiratory symptoms who were hospitalized in France between February and June 2020. Cases were patients who had a diagnosis of schizophrenia. Controls were patients who did not have a diagnosis of severe mental illness. The outcomes were in-hospital mortality and intensive care unit (ICU) admission. A total of 50,750 patients were included, of whom 823 were schizophrenia patients (1.6%). The schizophrenia patients had an increased in-hospital mortality (25.6% vs. 21.7%; adjusted odds ratio (aOR) 1.30 [95% CI 1.08-1.56], p = 0.0093) and a decreased ICU admission rate (23.7% vs. 28.4%; aOR 0.75 [95% CI 0.62-0.91], p = 0.0062) compared to controls. Significant interactions between schizophrenia and age for mortality and ICU admission were observed (p = 0.0006 and p < 0.0001). Schizophrenia patients between 65 and 80 years had a significantly higher risk of death than controls of the same age (+7.89%). schizophrenia patients younger than 55 years had more ICU admissions (+13.93%) and schizophrenia patients between 65 and 80 years and older than 80 years had less ICU admissions than controls of the same age (-15.44% and -5.93%, respectively). Our findings report the existence of disparities in health and health care between schizophrenia patients and patients without a diagnosis of severe mental illness. These disparities differed according to the age and clinical profile of schizophrenia patients, suggesting the importance of personalized COVID-19 clinical management and health care strategies before, during and after hospitalization for reducing health disparities in this vulnerable population.

End-of-life care among patients with schizophrenia and cancer: a population-based cohort study from the French national hospital database.

BACKGROUND: Patients with schizophrenia represent a vulnerable, underserved, and undertreated population who have been neglected in health disparities work. Understanding of end-of-life care in patients with schizophrenia and cancer is poor. We aimed to establish whether end-of-life care delivered to patients with schizophrenia and cancer differed from that delivered to patients with cancer who do not have diagnosed mental illness. METHODS: We did a population-based cohort study of all patients older than 15 years who had a diagnosis of advanced cancer and who died in hospital in France between Jan 1, 2013, and Dec 31, 2016. We divided this population into cases (ie, patients with schizophrenia) and controls (ie, patients without a diagnosis of mental illness) and compared access to palliative care and indicators of high-intensity end-of-life care between groups. In addition to unmatched analyses, we also did matched analyses (matched in terms of age at death, sex, and site of primary cancer) between patients with schizophrenia and matched controls (1:4). Multivariable generalised linear models were done with adjustment for social deprivation, year of death, time from cancer diagnosis to death, metastases, comorbidity, and hospital type (ie, specialist cancer centre vs non-specialist centre). FINDINGS: The main analysis included 2481 patients with schizophrenia and 222 477 controls. The matched analyses included 2477 patients with schizophrenia and 9896 controls. Patients with schizophrenia were more likely to receive palliative care in the last 31 days of life (adjusted odds ratio 1·61 [95% CI 1·45-1·80]; p<0·0001) and less likely to receive high-intensity end-of-life care-such as chemotherapy and surgery-than were matched controls without a diagnosis of mental illness. Patients with schizophrenia were also more likely to die younger, had a shorter duration between cancer diagnosis and death, and were more likely to have thoracic cancers and comorbidities than were controls. INTERPRETATION: Our findings suggest the existence of disparities in health and health care between patients with schizophrenia and patients without a diagnosis of mental illness. These findings underscore the need for better understanding of health inequalities so that effective interventions can be developed for this vulnerable population. FUNDING: Assistance Publique des Hôpitaux de Marseille and Aix-Marseille University.

Prevalence of and Risk Factors for Extrapyramidal Side Effects of Antipsychotics: Results From the National FACE-SZ Cohort.

BACKGROUND: Extrapyramidal side effects (EPS) have been identified as a complication of antipsychotic treatment. Previous meta-analyses have investigated EPS prevalence and risk factors in randomized clinical trials with highly selected patients, but studies in real-world schizophrenia are missing. OBJECTIVE: To examine the prevalence and clinical correlates associated with EPS in a nonselected national multicenter sample of stabilized patients with schizophrenia. METHODS: Between 2010 and 2016, patients suffering from schizophrenia (DSM-IV-TR criteria) were recruited through the FondaMental Academic Centers of Expertise for Schizophrenia (FACE-SZ) network and data were collected during a comprehensive 1-day-long standardized evaluation. The Simpson-Angus Scale and the Abnormal Involuntary Movement Scale were used to assess drug-induced parkinsonism (DIP) and tardive dyskinesia, respectively. RESULTS: The overall prevalence of DIP and tardive dyskinesia was 13.2% and 8.3%, respectively, in this community-dwelling sample of 674 patients. DIP was associated with negative symptoms (Positive and Negative Syndrome Scale [PANSS] subscore) (adjusted odds ratio [aOR] = 1.102, P < .001), first-generation antipsychotic prescription (aOR = 2.038, P = .047), and anticholinergic drug administration (aOR = 2.103, P = .017) independently of sex, age, disorganization (PANSS disorganized factor), and antipsychotic polytherapy. Tardive dyskinesia was associated with PANSS disorganized factor (aOR = 1.103, P = .049) independently of sex, age, negative symptoms, excitation, first-generation antipsychotic prescription, and benzodiazepine and anticholinergic drug administration. CONCLUSIONS: Our results indicate the high prevalence of EPS in a nonselected community-dwelling clinically stable sample of outpatients with schizophrenia. In the monitoring of antipsychotic treatment, EPS should be systematically evaluated, especially when negative symptoms and disorganization or cognitive alteration are present. Monotherapy with a second-generation antipsychotic should be preferentially initiated for patients with these side effects.

Significant Need for a French Network of Expert Centers Enabling a Better Characterization and Management of Treatment-Resistant Depression (Fondation FondaMental).

BACKGROUND: Major depression is characterized by (i) a high lifetime prevalence of 16-17% in the general population; (ii) a high frequency of treatment resistance in around 20-30% of cases; (iii) a recurrent or chronic course; (iv) a negative impact on the general functioning and quality of life; and (v) a high level of comorbidity with various psychiatric and non-psychiatric disorders, high occurrence of completed suicide, significant burden along with the personal, societal, and economic costs. In this context, there is an important need for the development of a network of expert centers for treatment-resistant depression (TRD), as performed under the leadership of the Fondation FondaMental. METHODS: The principal mission of this national network is to establish a genuine prevention, screening, and diagnosis policy for TRD to offer a systematic, comprehensive, longitudinal, and multidimensional evaluation of cases. A shared electronic medical file is used referring to a common exhaustive and standardized set of assessment tools exploring psychiatric, non-psychiatric, metabolic, biological, and cognitive dimensions of TRD. This is paralleled by a medico-economic evaluation to examine the global economic burden of the disease and related health-care resource utilization. In addition, an integrated biobank has been built by the collection of serum and DNA samples for the measurement of several biomarkers that could further be associated with the treatment resistance in the recruited depressed patients. A French observational long-term follow-up cohort study is currently in progress enabling the extensive assessment of resistant depressed patients. In those unresponsive cases, each expert center proposes relevant therapeutic options that are classically aligned to the international guidelines referring to recognized scientific societies. DISCUSSION: This approach is expected to improve the overall clinical assessments and to provide evidence-based information to those clinicians most closely involved in the management of TRD thereby facilitating treatment decisions and choice in everyday clinical practice. This could contribute to significantly improve the poor prognosis, the relapsing course, daily functioning and heavy burden of TRD. Moreover, the newly created French network of expert centers for TRD will be particularly helpful for a better characterization of sociodemographic, clinical, neuropsychological, and biological markers of treatment resistance required for the further development of personalized therapeutic strategies in TRD.

Clinical Decision-Making in the Treatment of Schizophrenia: Focus on Long-Acting Injectable Antipsychotics.

The purpose of this study was to identify clinician characteristics associated with higher prescription rates of long-acting injectable (LAI) antipsychotics, as well as the sources that influence medical decision-making regarding the treatment of schizophrenia. We surveyed 202 psychiatrists during six regional French conferences (Bordeaux, Lyon, Marseille, Nice, Paris, and Strasbourg). Data on the characteristics of practice, prescription rates of antipsychotic, and information sources about their clinical decisions were collected. Most psychiatrists used second-generation antipsychotics (SGAs), and preferentially an oral formulation, in the treatment of schizophrenia. LAI SGAs were prescribed to 30.4% of schizophrenic patients. The duration and type of practice did not influence the class or formulation of antipsychotics used. The clinicians following the higher percentage of schizophrenic patients were associated with a higher use of LAI antipsychotics and a lower use of oral SGAs. Personal experience, government regulatory approval, and guidelines for the treatment of schizophrenia were the three main contributing factors guiding clinicians' decision-making regarding the treatment of schizophrenia. The more clinicians follow schizophrenic patients, the more they use LAI antipsychotics. The development of specialized programs with top specialists should lead to better use of LAI antipsychotics in the treatment of schizophrenia.

Residual symptoms and specific functional impairments in euthymic patients with bipolar disorder.

OBJECTIVES: The aims of the present study were to confirm the impact of residual symptoms on overall functioning in a large sample of euthymic patients with bipolar disorder in real-life conditions and to explore the relationship between residual symptoms and specific areas of functional impairment. METHODS: This was a multicenter, cross-sectional, non-interventional study of euthymic outpatients with bipolar disorder. The Functioning Assessment Short Test was used to assess overall and specific domains of functioning (autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time). Various residual symptoms were assessed (residual mood symptoms, emotional dysregulation, sleep and sexual disorders, stigma, and perceived cognitive impairment). Logistic regression was used to determine the best model of association between functional domains and residual symptoms. RESULTS: Almost half of the 468 patients included (42%) had poor overall functioning. Residual depressive symptoms appeared to have an impact on overall functioning and in nearly all areas of functioning. In addition, specific residual symptoms had significantly more negative effects on some domains of functioning in euthymic patients with bipolar disorder (residual manic symptoms and occupational stigma on autonomy, emotional inhibition on occupational functioning, residual manic symptoms on financial issues, family stigma on interpersonal relationships, and sexual function and occupational stigma on leisure time). CONCLUSIONS: Our findings highlight the importance of evaluating overall functioning in clinical practice as well as functional domains. They also indicate that some residuals symptoms in patients with bipolar disorder should be targeted in personalized treatment plans, in order to improve functioning in the domains in which the patient is most impaired.

Assessment and management of agitation in psychiatry: Expert consensus.

BACKGROUND: Psychomotor agitation is associated with different psychiatric conditions and represents an important issue in psychiatry. Current recommendations on agitation in psychiatry are not univocal. Actually, an improper assessment and management may result in unnecessary coercive or sedative treatments. A thorough and balanced review plus an expert consensus can guide assessment and treatment decisions. METHODS: An expert task force iteratively developed consensus using the Delphi method. Initial survey items were based on systematic review of the literature. Subsequent surveys included new, re-worded or re-rated items. RESULTS: Out of 2175 papers assessing psychomotor agitation, 124 were included in the review. Each component was assigned a level of evidence. Integrating the evidence and the experience of the task force members, a consensus was reached on 22 statements on this topic. CONCLUSIONS: Recommendations on the assessment of agitation emphasise the importance of identifying any possible medical cause. For its management, experts agreed in considering verbal de-escalation and environmental modification techniques as first choice, considering physical restraint as a last resort strategy. Regarding pharmacological treatment, the "ideal" medication should calm without over-sedate. Generally, oral or inhaled formulations should be preferred over i.m. routes in mildly agitated patients. Intravenous treatments should be avoided.

Disparities in suicide mortality trends between United States of America and 25 European countries: retrospective analysis of WHO mortality database.

The objective was to examine changes in temporal trends in suicide mortality in 26 Western countries by retrospective trend analysis of the WHO mortality database on causes of deaths. From 1990 to 2010, there was a median reduction in suicide mortality of 22.7%, ranging from a 46% reduction in Estonia to a 26.2% increase in Romania. Suicide mortality decreased by ≥ 20% in 15 countries, and the reduction tended to be greater in countries with higher mortality in 1990. In most of the central European countries mortality strongly declined. The median changes in the age groups were -25.3% (range -62.9% to 72.6%) in people aged 15-24 years, -36.9% (-60.5% to 32.4%) in 25-34 years, -3.6% (-57.1% to 92%) in 35-54 years, -12.2% (-37% to 65,7%) in 55-74 years and -16.1% (-54.5% to 166.7%) in ≥ 75 years. Suicide prevention programs in youths and in the elderly seem to be effective (at least in females for the elderly) and efforts should be pursued in this way. However, suicide mortality of the people aged 35-54 years has increased in half of the studied countries between 1990 and 2010. Public policies should further orientate their efforts toward this population.

Preventing Alcohol Abuse Through Social Networking Sites: A First Assessment of a Two-Year Ecological Approach.

BACKGROUND: Prevention strategies to reduce alcohol use/consumption among young people are crucial to reducing alcohol-related deaths and preventing disease. This paper focuses on the effectiveness of a social networking site (SNS) alcohol prevention program targeted toward young people. OBJECTIVE: We hypothesized that the program would diminish the relation made by participants between alcohol and festive moments, and would result in a reduction of their declared consumption of alcohol at festive moments during the program. We also explored the interaction with the prevention program that was the most efficient. METHODS: The prevention program took the form of 3 lotteries over 2 years. The participants periodically received prevention messages, particularly on alcohol and festive moments (eg, videos on Facebook and short message service [SMS] text messages on their mobile phones). For the 3 periods, the participants had to answer questions exploring the level of their belief that alcohol consumption and festive moments are highly associated. A control group that did not participate in the prevention program was asked the same questions over the same number of days for the first 2 periods. During the second period, the participants were asked to answer questions about their alcohol consumption during parties. During the third period, we explored the interaction with the prevention program on the reduction of their belief that alcohol consumption and festive moments are associated. RESULTS: A total of 651 participants (age: mean 22.24, SD 4.10 years; women: n=430) during the first period, 301 participants (age: mean 21.27, SD 3.07 years; women n=199) during the second period, and 305 (age: mean 22.41, SD 4.65 years; women: n=190) during the third period correctly completed the survey. For the control group, 69 students completed the survey during the first period (age: mean 18.93, SD 1.14 years; women: n=59) and 50 during the second (age: mean 20.78, SD 1.94 years; women: n=45). We observed a significant reduction in the association of alcohol with festive moments in the participants over the 2 years (period 1: z=-4.80, P<.001; period 2: z=-2.11, P=.04; period 3: z=-2.30; P=.02), but not in the controls. We also observed a reduction in the number of glasses consumed during festive moments for the participants (z=-2.36, P=.02), but not for the controls during the second period. The third period showed that only the number of days since registration in the program had an impact on the reduction of the association of festive moments and alcohol consumption (t21=3.186, P=.005). CONCLUSIONS: The findings of this study suggest that the SNS prevention program is promising in preventing the association of alcohol with festive moments and, more generally, in impacting social norms.

The World Health Organization (WHO) dataset for guiding suicide prevention policies: A 3-decade French national survey.

BACKGROUND: Public health policies aim to prevent suicide in the general population. Assessing their effectiveness is required to further guide public health policies. The present article focuses on the French paradox. The French health care system was classified as the best in the world according the World Health Organization (WHO). However, suicide rates in France remain high compared to other European countries. The aim of the present article was to analyze (i) the evolution of suicide Age-Standardized Death (ASDRs) in France during the last three decades and the associations with socio-economic parameters and (ii) to understand which populations may specifically benefit from further targeted suicide prevention policies. METHODS: The database of the World Health Organization (WHO), freely available, was explored in April 2015. ASDRs were calculated each year by ratio between the number of deaths by suicide and the total population (per 100,000 inhabitants). Number of deaths by gender and age were also analyzed. RESULTS: Overall, ASDR suicide has decreased since 1987 in France (-32.8% between 1987 and 2010). However, France kept the same rank (10/26) when compared to other European countries between 1987 and 2010. The relative burden of suicide in all-causes mortality increased during the same period (+28.2%) while the total number of deaths by suicide increased only slightly (+3.9%). More specifically, the number of deaths by suicide increased substantially in [35-54] years old (+40%) and 75+ years old (+27%) males, and in [35-54] (+41%) years old females. Between 2000 and 2010, suicide rates significantly decreased when yearly mean income increased, and when general and psychiatric care beds decreased. CONCLUSION: Although ASDR suicide has decreased in France since 1987, this decline is quite modest when considering its universal access to care, the prevention of depression and suicide public policies. Suicide prevention public policies should focus on evaluation and improvement of prevention and care in the [35-54] years old population, and in the males aged 75+.

Can we well assess the relative efficacy and tolerability of a new drug versus others at the time of marketing authorization using mixed treatment comparisons? A detailed illustration with escitalopram.

OBJECTIVE: To assess the variation of relative efficacy and tolerability of an antidepressant versus others based on both pre-marketing (registration studies) and post-marketing studies versus pre-marketing studies only in patients with major depressive disorder. METHODS: The relative efficacy and tolerability of antidepressants was assessed by mixed treatment comparisons (MTCs) using data acquired over two time periods: before registration of the reference drug escitalopram (1989-2002) and up to 5 years later (1989-2007). Ranking probability outputs were presented for efficacy, using change from baseline to 8 weeks on Montgomery-Åsberg Depression Rating Scale total score, and tolerability, using withdrawals due to adverse events. RESULTS: The relative efficacy and tolerability of some selected antidepressants, including escitalopram, varied considerably over the two time periods. The improved relative efficacy and tolerability of escitalopram over time, compared with citalopram, was demonstrated by greater separation of ranking probability curves for efficacy and tolerability. In 2002, escitalopram ranked low with 13.9% and 5.1% probability of being in the top four antidepressants' relative efficacy and tolerability, respectively. In 2007, ranking probabilities for relative efficacy and tolerability of escitalopram increased to 52.5% and 82.1%, respectively. CONCLUSIONS: Time of marketing authorization may not be the most appropriate time to evaluate the relative efficacy and tolerability of a new antidepressant based on MTC approach due to the asymmetry of information between new and older compounds. However, the first evaluation of relative effect of a new drug for health technology assessment recommendations is commonly done at this time. Re-evaluation of a drug several years after its launch is likely to provide a more accurate indication of its relative efficacy and tolerability.

Discussion of prevalence and management of discomfort when swallowing pills: orodispersible tablets expand treatment options in patients with depression.

Many patients experience discomfort when trying to swallow tablets and capsules, but this issue is rarely discussed between patients and physicians. Discomfort when swallowing pills is common and arises due to the morphology of the oropharynx and esophagus, which are not well suited to swallowing rigid objects of small volume. Compliance with medication is poor in patients with chronic diseases such as depression. An inability or unwillingness to swallow medication can further reduce acceptance of and compliance with medication, which has an impact on effectiveness. Recognition that patient acceptance of prescribed medication is an important component of compliance has led to the development of pill-swallowing training programs and alternative formulations. Orodispersible tablets do not need to be taken with water and can be packaged discreetly in single doses. Orodispersible tablets have been shown to be effective in a number of therapy areas including depression.

Monitoring patients to improve physical health and treatment outcome.

Patients with schizophrenia suffer a number of comorbidities and a range of potential side effects from their medication, which contribute to a negative impact on their quality of life, and are sometimes responsible for lack of compliance and relapse. Side effects, in particular, can be identified by physicians, but only if they examine their patients regularly. Many physicians would suggest that this is good clinical practice for treating patients with schizophrenia, whatever the intended medication. This continuous monitoring might include weight gain, cognitive effects, and blood tests. In fact, patients appreciate being carefully monitored and it contributes to a good patient/physician relationship. This interaction has benefits in terms of impact on compliance and better control of symptoms due to treatment adherence (to appropriate doses), because it enables action before the patient stops taking medication. Good clinical practice suggests that investment in patient monitoring is offset by improved clinical outcomes.