Depressive episodes are associated with substantial worsening of HRQoL and account for a greater impairment on all domains of commonly used HRQoL measures to that reported with non-psychiatric medical disorders . Therefore, the use of multidimensional HRQoL scales that take into account a broad range of domains may help in understanding which factors influence depression outcomes and to which extent the coexisting psychiatric and non-psychiatric disease influence global functioning and subjective well-being.
This study examined the characteristics of patients with depression enrolled in outpatient psychiatric services in Italy and the relationship between the characteristics of depression (for example, severity and chronicity of depression, anxiety symptoms, painful symptoms), the impairment of HRQoL and the treatment patterns.
Consistent with the results obtained in the entire European population , the baseline results of the patients enrolled in the Italian sites have shown that functional somatic syndromes were reported in 35.9% of patients.
The mean HADS subscores for depression and anxiety in patients enrolled in Italy were 13.3 and 12.2, respectively, indicating a high comorbidity between depression and anxiety in patients being treated with antidepressants.
A rate of 65.1% of patients enrolled in the Italian sites had pain at enrolment according with Kelly definition, although a defined medical disorder known to cause pain was present in only 20.3% of the patients examined at baseline. The relatively high rate of patients reporting pain in absence of a recognised medical disorder associated with pain or without further comorbidities might be explained on the basis of the well-known correlation between medically unexplained symptoms and comorbid anxiety and depression disorders [19, 20], as well as on the presence of multiple otherwise unexplained symptoms in somatic functional disorders, all of which share a psychopathologic causative origin .
The results for baseline SF-36 domains in the Italian patients were similar to those obtained in the overall European population in all examined parameters , including mean scores for PCS and MCS, mean scores for individual domains, type of domains showing the worst health status (which were limitations due to emotional problems, mental health and social functioning). Moreover, all examined domains had a mean score < 50 (that is, below the population norm) both in Italy and in all European countries.
In our sample of patients, pain was shown to affect HRQoL perception, both measured by means of the two SF-36 subscales (mental and physical components) and of EQ-5D (health state and VAS), as well as the level of depression and anxiety measured by means of the two HADS subscales was affected by concomitant pain. The median total score for overall pain VAS related to symptoms in the last week was 45.0, thus indicating that a relevant amount of patients were suffering of significant pain (that is, with a score in overall pain VAS ≥ 30). The results of the SSI-28 also showed no differences in mean scores between the pain and somatic items. As in the European population , the 'interference of pain with daily activities' and the 'amount of time patient was awake and had pain' were the two items of the pain VAS scale that showed the highest level of impairment.
The concomitant presence of both psychiatric and non-psychiatric diseases was associated with a worse EQ-5D health status and VAS mean scores. Conversely, the presence/absence of a previous episode of depression in the last 24 months and the duration of the current depressive episode were factors that did not influence both the mean scores for the mental and physical components of the SF-36 and the mean HADS subscores for depression and anxiety.
The results of the baseline data collected in the overall European population  have shown that, consistently with findings of a recent review of epidemiological studies conducted in Europe , more than 40% of patients had at least one comorbid chronic medical condition. Patients without any comorbidity showed a better outcome on all domains of the physical component of the SF-36, while depression was shown to have considerable influence on the mental summary of the SF-36. Both health state and VAS of the EQ-5D scores were less than half of the maximum possible score and were further reduced in patients with comorbidities. Further analysis of the Italian subsample will add information about the practice of Italian psychiatrists in the management of depression and in the attention to the somatic components/comorbidities of depression.
Certain limitations of the study should be mentioned. First, the results presented here derive from a series of centres not necessarily representing all the several types of psychiatric outpatient services in the country. A second limitation is that, even though the study is an observational one, criteria for recruitment did not request a formal psychiatric diagnosis of depression according to the classification systems usually employed (for example, the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV) and International Classification of Diseases, 10th edition (ICD-10)).
In summary, the baseline data derived from the Italian cohort of the FINDER study provide important information on the level of clinical and functional impairment, and of worsening of HRQoL, in patients with depression usually seen in outpatient psychiatric services for receiving pharmacological treatment. Furthermore, the role of several factors in worsening the patients' HRQoL perception at enrolment can be of clinical relevance in daily practice. The longitudinal data of the patients will give country-specific information on those factors that may influence the patients' HRQoL outcomes after a 6-month treatment for depression has been administered. In this respect, the FINDER study was designed with no restrictive limitation in terms of prescribed pharmacological treatment, which was left at the complete discretion of the treating psychiatrist, in order to have a real-life sample of patients initiating treatment for a depressive episode. The contribution of depression and comorbidities, as well as pain perception, will be taken into account when interpreting changes in SF-36 and EQ-5D scores following antidepressant treatment.