A national act (Order SSI/1356/2015) regulating Post-Launch Evidence Generation (PLEG) studies was set in Spain in 2015. These PLEG studies are to inform decisions about technologies already included in the Benefit Portfolio of the Spanish National Health System (SNHS) in order to confirm/exclude/modify their terms of use. Once a PLEG is established the selected hospitals provide the technology according to a common protocol and register outcomes until the required sample size is reached.

The PLEG studies are prospective, observational and single arm studies on safety, effectiveness and cost-effectiveness of a technology in real practice. The technology is selected because of the identification of an evidence gap, usually through a health technology assessment (HTA) report made by an agency of the Spanish Network of HTA Agencies (RedETS). The execution of a PLEG is assigned to one of the RedETS Agencies, which is responsible of delivering annual reports and a final report when the objectives are reached.

The following six PLEG studies, all of them on medical devices, have been launched in Spain so far, i) Endobronchial valve for patients with persistent air leak; ii) Biodegradable esophageal stent; iii) Percutaneous mitral valve repair system by clip; iv) Left Atrial Appendage Closure Device; v) Sensor-based glucose monitoring systems for children with type 1 diabetes mellitus; vi) Left ventricular assist devices for destination therapy. Five studies will finish their data collection by the end of 2020 or during 2021.

A new national procedure using PLEG has been made available in Spain facilitating the use of real-world evidence to inform national decision-making on the financing of selected technologies due to uncertainties about their effectiveness, safety, cost-effectiveness and organizational impact. The studies are requiring a high amount of coordination tasks, as they are involving an average of 21 hospitals each. The usefulness and suitability of this procedure to achieve its objectives must be evaluated once their results are available.

The main factors that are involved in a correct adherence to the therapeutic recommendations in Bipolar Disorder includes aspects related to age, sex, ethnicity, socioeconomic level and characteristics of the illness associated with the severity, comorbidity and adverse effects related to previous medicine.

To analyse the individual perception that the patient with Bipolar Disorder has regarding the positive and negative aspects of taking the recommended medication.

Descriptive and interpretative observational study under the qualitative paradigm of research, extracting the data through the completion of four focus groups with ten patients everyone. To complete the codification of the content of the participant’s discourses, we rely on the QRS NVivo 10 computer program.

In the participant’s discourse concerning the main barriers to pharmacological treatment, for example “It’s because we live in a society and, because of that, we don’t go without medicine; if we didn’t live in society, we wouldn’t take medicine because we wouldn’t bother anyone”. Some examples of patient’s discourse, about perceived facilitators were: “I have to take medicine for my bipolar disorder, that’s it, I have a treatment, my illness has a name”.

The main facilitators regarding the use of pharmacological treatment in Bipolar Disorder are the perceived need for treatment in the acute phase and the recognition of the illness, the shared clinical decision and the causal biological attribution in the chronic phase. About perceived barriers, social control is identified in both phases, adverse effects in the acute cases and the absence of effective treatment in the chronic state.

Comorbidity has been defined as the coexistence of somatic and psychiatric diseases with diferent physiopatology in the same person, and it can appear simultaneously to the schizophrenia or during the patient's lifetime. There are two types of comorbidity: episodical or taking place during the lifetime of the patient. We can diffferenciate between comorbidity itself (in cluster, dependent or associated) to the so-called pseudo-comorbidity. Besides, comorbidity has been classified as a co-syndrome and it is considered a prognosis indicator of this disease, which can determine an increase in the rates related to relapses, worse response to treatment, less capacity to cope with social situations, and suicide in patients suffering from schizophrenia.

177 schizophrenic patients were assessed for affective symptoms and suicide behaviour. 24.3% were suffered for depression. 35% had a previous record of autolytic attempts. The rate of suicide history were higher among depressed schizophrenics (50%) than non-depressed schizophrenics (20%) (p<0,05).

We point out the clinic importance of suicide in schizophrenic patients suffering from depression. Moreover, the study shows the necessity to carry out longitudinal studies to recognize indicators of depression in advance and establish the diagnosis of depression, and, also, to acknowledge the importance of the gender factor in the depression of schizophrenic patients.

Excessive cortical cerebrospinal fluid (CSF) has been acknowledged as a possible marker of a gray matter loss. This excess in schizophrenia is found predominantly in the prefrontal and temporal regions. We hypothesized that the poorer global outcome and treatment response in males with schizophrenia are related to a greater cortical volume loss as compared to females.

In order to test this hypothesis we have used magnetic resonance imaging (MRI) to study the cortical (prefrontal, temporal, and hemispheric) CSF values in a group of 85 patients with schizophrenia, of whom 56 were males and 29, females. We calculated the residual values of CSF in the patients based on the data pertaining to 45 control subjects and linear regression, from which the normal effects of age and intracranial volume were discounted. These residual scores constitute a quantitative measurement of the excess of CSF due to the disease.

Males, but not females, presented a trend-level significant excess of left prefrontal CSF. The prefrontal and temporal residual values were significantly associated with illness duration in males, but not in females.

These results conform to the worse outcome and the higher severity of structural abnormalities generally found in schizophrenia in male subjects.

Our data support the hypothesis of accelerated prefrontal cortical loss in males, but not in females with schizophrenia.

Depression is very common among institutionalized elders. Because of the increased risk of cognitive impairment/dementia, and mortality we want to describe the evolution of depression and analyze predictive factors.

In the Aging Trajectories Study (Instituto Superior Miguel Torga - Coimbra), we followed up a sample of 83 nondemented persons (M ± SD baseline age = 79.51 ± 6.58; men: 17; women: 66). In a 2-year prospective cohort analysis (2010-2011, and 2013), we assessed depression using the Geriatric Depressive Scale/GDS as screening tool and the Mini International Neuropsychiatric Interview to diagnose depression. We also used the UCLA Loneliness Scale, the Geriatric Anxiety Inventory/GAI, the Positive and Negative Affect Scale/PANAS. Sociodemographics, and health were control variables. We performed a multinomial logistic regression to identify predicitive factors.

Fifty participants had depression at baseline, nine developed, 49 maintained, nine remitted, and 16 maintained without depression.

Having depression was associated with worse scores in UCLA, GAI, and PANAS. Not having depression was correlated with higher positive affect.

Baseline higher GAI and UCLA, and lower positive affect and satisfaction predicted recurrent depression.

Improvement in GDS, GAI, and positive affect predicted depression remission.

Results show that depression is a concern issue for professionals working with institutionalized elderly. Anxiety, loneliness, low positive affect and satisfaction constitute a risk factor for maintaing depression in institutionalized elderly and low anxiety and depressive symptoms are a protective factors for depression. These results could be used in depression prevention programs.

Cognitive rehabilitation techniques, reminiscence therapy, and reality orientation therapy, have shown an impact on cognition, life satisfaction, mood, and on the progression of cognitive decline in elderly.

To test the effectiveness of a NRGP on the cognitive and emotional functioning of institutionalized elderly.

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single blind randomized controlled study with paired groups.

Coimbra institutionalized elderly, aged between 64-92 (N = 88) with cognitive impairment no dementia, mostly women (75.0%).

randomization of participants to the rehabilitation group/RG (n = 41) and to the comparison/waiting-list group/CG (n = 23). NRGP involved groups of five elders, and took 90 min. per day, once a week, for 10 weeks.

Mini-Mental State Examination/MMSE, Frontal Evaluation Battery/FAB, Geriatric Depression Scale/GDS.

We used general linear model with repeated measures analysis of variance.

RG improved significantly on cognitive, and executive function (p < 0.001), and CG worsened on cognitive, executive function, and mood (p < 0.01). There was a significant effect on the MMSE, FAB, and GDS scores, after excluding pre-rehabilitation scores as covariates [F (1, 81) = 43.98, p < 0.001; η2 = 0.35; F(1, 80) = 28.37, p < 0.001; η2 = 0.26; F(1, 79) = 19.66, p < 0.001; η2 = 0.20].

A NRGP including cognitive rehabilitation, reminiscence therapy, and reality orientation proved to be effective on cognitive and executive functioning, and on depressive symptoms of institutionalized elders with cognitive impairment no dementia.

Decision capacity (DC) is a complex construct, whose assessment poses huge challenges to Liaison Psychiatrist (LP).

Assess factors related to DC in patients with somatic disorders admitted in medical and surgical departments of a general hospital.

Clinical records of patients who were submitted to a DC assessment at Hospital Fernando Fonseca (Portugal), from 1st January 2012 to 31st December 2014 were retrospectively analysed. Collected data were statistically analysed with SPSS®. Univariable analysis was performed, in order to determine factors related to DC.

Data from 35 patients subject to DC evaluation were considered, of whom 42.4% were considered unable to give consent to medical and/or surgical procedures. Most of these assessments were related to patients who refused treatment. Patients unable to decide were predominantly male and mainly affected by organic mental or neurocognitive disorders (P < 0.05). There were no statistical significant differences in the age of those considered able or unable to decide. After PL intervention, 40% of those considered unable to decide changed their decision. However, it was not significantly related to the ability to give consent.

Neurocognitive disorders are common diagnosis found in patients admitted in somatic departments with no DC. Frequent change in decision after LP intervention may reflect not only cognitive fluctuations, but also a possible influence of LP intervention on patients’ choices. Appropriate standardized measures are useful tools in assessing patients with cognitive impairment, reducing evaluation differences between professionals, and in order to increase LP decisions credibility.

The authors have not supplied their declaration of competing interest.

Life functioning difficulties are a relevant but undervalued consequence of major depression. Mood symptoms and cognitive deficits have a significant, and somehow independent, impact on them. Therefore, cognitive difficulties should be considered a potential target to improve patients’ functioning.

To examine the degree in which objective and subjective cognition explain functional outcome.

To assess objective cognitive function (CF) with a neuropsychological battery and to measure subjective CF using measures of cognitive perception.

Ninety-nine patients with depression were assessed by age, sex and level of schooling. Depressive symptoms severity was measured by Hamilton Depression Rating Scale (HDRS-17). Objective CF consisted in the following cognitive domains: memory, attention, executive functioning and processing speed. Subjective CF was assessed with Perceived Deficit Questionnaire-Depression (PDQ-D). Functioning Assessment Short Test (FAST) was used to evaluate life functioning, excluding the cognitive domain. All the listed measures were included in a multiple regression analysis with FAST scores as dependent variable.

The regression model was significant (F1,98 = 67.484, P < 0.001) with an R of 0.825. The variables showing statistical power included (from higher to lower β-coefficient) HDRS-17 (β = 0.545, t = 8.453, P < 0.001), PDQ-D (β = 0.383, t = 6.047, P < 0.001) and DSST (β = −0.123, t = −1.998, P = 0.049).

The severity of depressive symptoms is the variable that best explains life functioning. Surprisingly, the second factor hindering it is the patients’ perception of their cognition. Current findings highlight the importance of correcting cognitive bias in order to improve functionality. However, results have to be taken cautiously as mood symptoms could partly explain the bias.

The authors have not supplied their declaration of competing interest.

The authors have not supplied their declaration of competing interest.

Major depression cognitive impairments lasts in remission periods, have an impact on treatment outcome and hamper psychosocial functioning. Thus, its accurate detection and specific treatment has become a crucial step.

In order to assess objective cognitive functioning (OCF), a neuropsychological battery was administered. For subjective cognitive functioning (SCF), cognitive perception was evaluated by clinicians and patients.

To determine the concordance between OCF and SCF.

One hundred and two patients were grouped according to Hamilton Depressive Rating Scale (HDRS−17): 18 remitters (RE < 7), 40 partly remitters (PR, 7–18) and 44 acutely depressed (AD > 18). OCF was computed combining T-scores of digit symbol substitution test (WAIS-IV) with two RAVLT subtests (learning and memory). SCF was assessed with a CGI adaptation for cognitive disturbances severity.

The OFC was 41.21(8.49) for all patients and 45.54(6.8), 41.93(6.8) and 38.7 (9.7) for RE, PR, and AD, respectively. Psychiatrist and patients’ SCF had a poor agreement (α=0.518), with Cronbach's alpha for RE, PR and AD of −0.607, 0.518 and 0.404. Concordance between OCF and SCF was calculated for all patients (psychiatrist, r = −0.317, P = 0.002; patient, r = −0.310, P = 0.002), for RE (r = −0.535, P = 0.022; r = 0.395, P = 0.105) for PR (r = −0.013, P = 0.94; r = −0.328, P = 0.045) and for AD (r = −0.252, P = 0.122; r = −0.333, P = 0.033). Patients rated their SFC as more impaired than did clinicians.

Concordance between clinicians and patients regarding SCF is very poor, worsening in AD group and being null in remission. This study also points out that CF is best detected by patients in acute episodes and by psychiatrists when patients are in clinical remission.

The authors have not supplied their declaration of competing interest.

Obtain and analyze information on treatment guidelines, with particular emphasis on the use of antipsychotics, in patients diagnosed with bipolar disorder I and bipolar disorder II who are treated at a mental health center in a district of Madrid (Spain) under the conditions of habitual clinical practice.

Then, compare with recently published literature.

We performed a descriptive study of a sample of 100 patients diagnosed with bipolar disorder (type I and type II) at any stage of the disease who receive regular treatment in a mental health center in a district of Madrid. Information regarding the treatment used, especially the use of antipsychotics (either in a single therapy or in combination with other drugs such as mood stabilizers, antidepressants, hypnotics or anxiolytics), was collected retrospectively from the data obtained from the medical record.

Ninety-four percent of patients are taking mood stabilizer treatment (68% lithium, 24% valproate, 1% and 1% carbamazepine and lamotrigine). Four percent take lithium and valproate in combination. Forty-eight percent of patients are taking some antipsychotic (atypical about 90%). Of these, only 10% in injectable form, and 5% take both oral and injectable antipsychotics.

The diminished use of injectable antipsychotics, well below recent publications, draws the attention. You can probably explain this low proportion of injectable medication because we are generally dealing with stable patients with a long-term disorder.

The authors have not supplied their declaration of competing interest.