Economic impact of treatment-resistant depression: A retrospective observational study.

BACKGROUND: To determine the incidence of Treatment-Resistant Depression (TRD) in Spain and to estimate its economic burden, using real world data. METHODS: A retrospective, observational-study was carried out using data from the BIG-PAC database®. Patients aged ≥18 years with a diagnosis of major depressive-disorder (MDD) who initiated a new antidepressant treatment in 2015-2017 were included. The patients were classified as TRD and non-TRD. Patients were classified as TRD if they had, during the first year of antidepressant treatment: a) failure with ≥2 antidepressants including the prescription of ≥3 antidepressants (N06A) or ≥2 antidepressant and ≥1 antipsychotic (N05A; including lithium) b) antidepressants administered for ≥ 4 weeks each, and c) the time between the end of one treatment and the initiation of the next was ≤ 90 days. Inherent limitations of data collection from databases should also be considered in this analysis (e.g., lack of information about adherence to treatment). Follow-up period: 18 months. The incidence rate was calculated as the number of TRD patients per 1,000 persons-year divided by the population attended. OUTCOMES: direct healthcare and indirect costs. Two sensitivity analyses were performed varying the index date and the period used to define TRD patients (6 vs.12 months). RESULTS: 21,630 patients with MDD aged ≥ 18 years (mean age: 53.2 years; female: 67.2%) were analyzed, of whom 3,559 met TRD criteria, yielding a 3-year cumulative incidence of 16.5% (95%CI: 16%-17%) among MDD patients. The annual population incidence rate of TRD in 2015-2017, was 0.59, 1.02 and 1.18/1,000 person-years, respectively (mean: 0.93/1,000 person-year). Overall, mean total costs per MDD patient were €4,147.9, being higher for TRD than for non-TRD patients (€6,096 vs. €3,846; p<0.001): a) direct costs (€1,341 vs. €624; p<0.001), b) lost productivity (€1,274 vs. €821; p<0.001) and c) permanent disability (€3,481 vs. €2,401; p<0.001, adjusted). Sensitivity analyses showed no differences with the reported results. CONCLUSIONS: The population based TRD incidence in Spain was similar to recent data from other European countries. TRD is associated with greater resource use and higher costs compared with non-TRD patients.

Epidemiology and costs of depressive disorder in Spain: the EPICO study.

Depressive Disorders are the most common psychiatric diagnoses in the general population. To estimate the frequency, costs associated with Depressive Disorders in usual clinical practice, and in the whole Spanish population, a longitudinal, retrospective, observational study was carried out using data from the BIG-PAC database®. Study population: all patients aged ≥ 18 years with a diagnosis of a Depressive Disorder in 2015-2017. Prevalence was computed as the proportion of Depressive Disorder cases in the adult general population, and the incidence rate, as the number of new Depressive Disorder cases diagnosed per 1,000 person-years in the population using health services, during 2015-2017. We collected demographic variables, comorbidity, direct health costs, and indirect costs (temporary and permanent disability). Health costs related to Depressive Disorders were estimated according to the annual resource use rate (resource/patient/year). Indirect costs were calculated according to the human capital method. Using the study data and information from the Spanish National Institute of Statistics, we estimated the cost of Depressive Disorders corresponding to the Spanish adult population, including premature mortality. 69,217 Depressive Disorder patients aged ≥ 18 years who met the inclusion/exclusion criteria were studied (mean age: 56.8 years; female: 71.4%). Prevalence of Depressive Disorders in the general population was 4.73% (95% CI: 4.70-4.76%). Annual incidence rates (2015-2017) were 7.12, 7.35 and 8.02 per 1,000 person-years, respectively. Total costs observed in our Depressive Disorder patients were € 223.9 million (corresponding to a mean of € 3,235.3; mean/patient/year), of which, 18.4% were direct health care costs and 81.6%, non-health indirect costs (18% temporary occupational disability, 63.6% permanent disability). Considering also the cost of premature death, the mean cost per patient/year was € 3,402 and the estimated societal costs of Depressive Disorders in Spain were € 6,145 million. The prevalence and incidence of Depressive Disorders are consistent with other series reviewed. Resource use and total costs (especially non-health costs) were high.

Real-world data on paliperidone palmitate for the treatment of schizophrenia and other psychotic disorders: a systematic review of randomized and nonrandomized studies.

The aim of this study was to perform a systematic review of the effects of 1-month paliperidone palmitate (PP1M) for the treatment of schizophrenia and related psychotic disorders in terms of outcomes reported in real-world evidence studies. A systematic review of real-world randomized and nonrandomized studies with PP1M was performed and is reported according to PRISMA guidelines. Comparative effectiveness data with oral antipsychotics indicate that PP1M has a lower likelihood of relapse-related events, including rehospitalization, and these differences are clinically relevant. A randomized, double-blind study showed that PP1M has no advantage over haloperidol decanoate in the time to treatment failure. Although there was a marked variability across studies, PP1M was not superior to other antipsychotics in terms of study completion rates. Pharmacoeconomic data show that, during a follow-up period of 12 months, the mean total healthcare cost was not significantly different in patients treated with PP1M compared with those receiving oral antipsychotics. The mean maximum prolactin levels were significantly higher with PP1M than with haloperidol decanoate; however, neither drug differs in the frequency of prolactin-related adverse events. Results on prolactin-related adverse events were inconsistent in two randomized comparisons with oral antipsychotics and were not reported in a randomized comparison with aripiprazole. There were no significant differences between haloperidol decanoate and PP1M in the severity of abnormal involuntary movements and parkinsonism, or in the incidence of tardive dyskinesia; however, patients treated with haloperidol decanoate showed greater worsening of akathisia and required treatment for parkinsonism and akathisia significantly more frequently than patients who received PP1M. In conclusion, real-world data that originate from both pragmatic randomized clinical trials and observational studies indicate that PP1M is superior to oral antipsychotics in delaying the time to relapse or treatment failure. Furthermore, the pharmacoeconomic data reviewed for this article suggest that the advantages of PP1M compared with oral antipsychotics are not associated with an increased total cost for healthcare providers.

Consenso español de salud física del paciente con depresión / Spanish consensus on the physical health of patients with depressive disorders

La comorbilidad entre depresión y enfermedades físicas es muy frecuente y tiene un impacto importante en el deterioro de la salud así como en la atención y tratamiento recibidos. Impulsado por las Sociedades Españolas de Psiquiatría y Psiquiatría Biológica, y la Sociedad Española de Médicos de Atención Primaria (SEMERGEN) se realizó un consenso sobre la salud física en el paciente con depresión, que de forma resumida se expone en el presente trabajo. La revisión de la literatura puso de manifiesto la elevada frecuencia en pacientes con depresión de trastornos cardiovasculares y trastornos endocrinometabólicos como la obesidad y la diabetes, de tal modo que en pacientes con depresión serían aplicables las recomendaciones de prevención primaria y secundaria establecidas para los individuos con riesgo cardiovascular o metabólico. También es frecuente la comorbilidad entre depresión y dolor crónico, que obliga a la detección activa de ambos trastornos y a una intervención terapéutica integral. La presencia de esta comorbilidad puede condicionar, aunque no impedir el tratamiento farmacológico en cuya elección se deberá tener en cuenta los efectos secundarios y las interacciones de los distintos antidepresivos. Por su parte, la psicoterapia puede contribuir a la recuperación integral del enfermo. Globalmente, en el proceso de atención al paciente con depresión y enfermedades físicas comórbidas es fundamental la coordinación del médico de atención primaria, el psiquiatra y otros especialistas o profesionales implicados (AU)

Comorbidity between depression and physical illnesses is very common and has a significant impact on the health and management of the patient. With the support of the Sociedades Españolas de Psiquiatría y Psiquiatría Biológica, and Sociedad Española de Médicos de Atención Primaria (SEMERGEN) a consensus was prepared on physical health in patients with depression and is summarized in the present work. The literature review highlighted the high frequency of cardiovascular and endocrine-metabolic disorders in patients with depression such as diabetes and obesity, thus making the primary and secondary prevention recommendations for patients with cardiovascular or metabolic risk applicable to patients with depression. Comorbidity between depression and chronic pain is also frequent, and requires an integrated therapeutic approach. The presence of physical illness in patients with depression may condition, but not preclude, the pharmacological treatment; drug selection should take into account potential side-effect and drug-drug interactions. On the other hand, psychotherapy may contribute to the patient's recovery. Overall, coordination between the primary care physician, the psychiatrist and other health professionals involved is essential for the management of patients with depression and concomitant physical illness (AU)

Spanish consensus on the physical health of patients with depressive disorders.

Comorbidity between depression and physical illnesses is very common and has a significant impact on the health and management of the patient. With the support of the Sociedades Españolas de Psiquiatría y Psiquiatría Biológica, and Sociedad Española de Médicos de Atención Primaria (SEMERGEN) a consensus was prepared on physical health in patients with depression and is summarized in the present work. The literature review highlighted the high frequency of cardiovascular and endocrine-metabolic disorders in patients with depression such as diabetes and obesity, thus making the primary and secondary prevention recommendations for patients with cardiovascular or metabolic risk applicable to patients with depression. Comorbidity between depression and chronic pain is also frequent, and requires an integrated therapeutic approach. The presence of physical illness in patients with depression may condition, but not preclude, the pharmacological treatment; drug selection should take into account potential side-effect and drug-drug interactions. On the other hand, psychotherapy may contribute to the patient's recovery. Overall, coordination between the primary care physician, the psychiatrist and other health professionals involved is essential for the management of patients with depression and concomitant physical illness.

The role of the clinical research coordinator--data manager--in oncology clinical trials.

BACKGROUND: The purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials. METHODS: Forty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents. RESULTS: A response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits. CONCLUSIONS: CRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data.