Quality of care indicators for schizophrenia: determinants of observed variations among Italian Departments of Mental Health. Results from the ETAS DSM study.

AIMS: The primary aim of this study is to analyse the conformance of usual care patterns for persons with schizophrenia to treatment guidelines in three Italian Departments of Mental Health (DMHs). The secondary aim is to examine possible organisational and structural reasons accounting for variations among DMHs. METHODS: Within the framework of the Evaluation of Treatment Appropriateness in Schizophrenia (ETAS) project, 20 consensus quality of care indicators were developed. Ten concerned pharmacological treatment and ten encompassed general care and psychosocial rehabilitation interventions. Indicators were calculated using data from a stratified random sample of 458 patients treated at three DMHs located in North-Eastern, North-Western and Southern Italy. Patients' data were collected by combining information from medical charts and from a survey carried out by the health care professionals in charge of the patients. Data on the structural and organisational characteristics of the DMHs were retrieved from administrative databases. For each indicator, the number and percentage of appropriate interventions with and without moderators were calculated. Appropriateness was defined as the percentage of eligible patients receiving an intervention conformant with guidelines. Moderators, i.e., reasons justifying a discrepancy between the interventions actually provided and that recommended by guidelines were recorded. Indicators based on a sufficient number of eligible patients were further explored in a statistical analysis to compare the performance of the DMHs. RESULTS: In the overall sample, the percentage of inappropriate interventions ranged from 11.1 to 59.3% for non-pharmacological interventions and from 5.9 to 66.8% for pharmacological interventions. Comparisons among DMHs revealed significant variability in appropriateness for the indicators 'prevention and monitoring of metabolic effects', 'psychiatric visits', 'psychosocial rehabilitation', 'family involvement' and 'work'. After adjusting the patient's gender, age and functioning, only the indicators 'Prevention and monitoring of metabolic effects', 'psychiatric visits' and 'work' continued to differ significantly among DMHs. The percentage of patients receiving appropriate integrated care (at least one appropriate non-pharmacological intervention and one pharmacological intervention) was significantly different among the three DMHs and lower than expected. CONCLUSIONS: Our results underscore discrepancies among Italian DMHs in indicators that explore key aspects of care of patients with schizophrenia. The use of quality indicators and improved guideline adherence can address suboptimal clinical outcomes, and has the potential to reduce practice variations and narrow the gap between optimal and routine care.

A comparative, randomized, double-blind study of trazodone prolonged-release and sertraline in the treatment of major depressive disorder.

OBJECTIVES: To evaluate the efficacy and safety of trazodone prolonged-release compared with sertraline in the treatment of patients with major depression. RESEARCH DESIGN AND METHODS: A total of 122 patients aged 19-64 years were enrolled in this multicenter, double-blind, double-dummy, randomized, comparator-controlled study. Patients received 7 days of single-blind placebo treatment followed by 6 weeks of double-blind treatment with trazodone prolonged-release 150-450 mg/day (n = 62) or sertraline 50-100 mg/day (n = 60). OUTCOME MEASURES: Efficacy was evaluated by mean changes from baseline in the Hamilton Depression Rating scale (HAM-D), Montgomery Asberg Depression Rating Scale, Hamilton Anxiety Rating scale, and the Clinical Global Impression-Global Improvement/Severity scores; and by the rates of patients responding to treatment and considered to be in remission. Time to onset of efficacy and safety were assessed. RESULTS: Trazodone and sertraline were equally effective in reducing depressive symptoms and promoting remission, and had similar onset times. In the Intent-to-Treat population, there were no significant differences in favor of trazodone at study endpoint in all efficacy measures, while a statistically significant difference was detected in the Per-Protocol population on HAM-D and in the percentage of responders. Analysis of HAM-D factors (anxiety/somatization, cognitive disturbance, retardation, and sleep disturbance) indicated that sleep disturbances were significantly less evident for patients taking trazodone at study endpoint. Adverse drug reactions, mostly of mild intensity, were reported in 42% of trazodone-treated patients (mainly of the nervous system) and 43% of sertraline-treated patients (mainly gastrointestinal). One event was considered to be serious: a patient treated with trazodone 450 mg/day showed moderate anxiety/tremor/insomnia and was hospitalized. Treatment was discontinued; the patient made a full recovery. CONCLUSIONS: This study showed that after 6 weeks, trazodone and sertraline were not different in reducing symptoms of depression and in producing disease remission. Tolerability profiles reflected the differing pharmacological properties of these antidepressants. Trazodone may be a therapeutic option in the treatment of patients with major depression showing prevalent sleep disturbances.

Improving compliance in depression: a systematic review of narrative reviews.

BACKGROUND AND OBJECTIVE: Narrative reviews represent a popular source of information for clinicians, especially where the evidence on a given subject is sparse and analogies from other fields of medicine may help in filling the information gap. Unfortunately, narrative reviews often follow less stringent criteria for information selection and appraisal than systematic reviews, potentially leading to incomplete or biased recommendations. The objective of the present study was to examine the quality of the recommendations provided by narrative reviews on how to improve patient adherence to pharmacological treatment of unipolar depressive disorders. METHOD: We sought to locate all narrative review papers addressing adherence to treatment in unipolar depressive disorders. In order to do so, we searched Medline and PsychInfo from 1980 to December 2003, using the following keywords: review, depressive disorders, treatment, dropout, patient compliance and adherence. We inspected the title and the abstract, whenever available to identify the relevant reviews and obtained a full copy of the publications in this subset, and read the articles to identify further relevant reviews. These were in turn copied and reviewed, until no further references were found. RESULTS AND DISCUSSION: We identified 23 reviews, providing a total of 87 recommendations. The most common recommendation was for patient education (19 times), patient-physician empathy/alliance (14 times), and education of family (nine times). Reviewers' recommendations were based on the literature on depression 54 times, and on other medical conditions 17 times. A critical appraisal of the evidence base of the recommendations showed that randomized controlled trials or meta-analyses were quoted to support the recommendations only 23% of the times, while important interventions of proven efficacy in the field of depression or in other chronic conditions (e.g. medication clinics, training of nurses, psychological treatment, and telephone follow-up) were not mentioned. CONCLUSIONS: Narrative reviews on adherence to pharmacological treatment of depressive disorders suffer not only from the limited availability of good quality evidence, but also from an incomplete critical appraisal of available evidence on interventions both for depression and for other chronic disorders.

Understanding treatment adherence in affective disorders: a qualitative study.

The objective of this study was to explore the perspective of depressed patients, their family and mental health professionals from their community mental health centre (CMHC) on factors related to treatment adherence. We conducted eight separate focus groups involving patients, their families and their therapists from three CMHCs. A total of 52 persons were involved. The groups explored patients' and family's explanatory model of depression, perceptions about the course of the disease, the role of medication and other treatments, the main causes of non-adherence, and interventions which would help increase it. Patients and families had a complex cognitive model of depression, which combined intrinsic vulnerability, psychological suffering during childhood and adolescence, and adverse life events. Drugs as well as other treatments were considered helpful, more so by patients than by family members. Denial of the disease and need to test its continuing presence were the main causes of non-adherence for patients, while adverse reactions did not play a relevant role. Mental health professionals tended to underestimate non-adherence in depressed patients, and did not question their patients about medication adherence. Family members needed more information on depression, on how to manage their relatives, as well as psychological and social support for themselves. The study allowed for the identification of a number of specific interventions aimed at facilitating treatment adherence, such as providing more information to patients and families, and training doctors and nurses in effective prevention and management of non-adherence.

Patient adherence in the treatment of depression.

BACKGROUND: Non-adherence with antidepressant treatment is very common. Increasing adherence to pharmacological treatment may affect response rate. AIMS: To review and summarise quantitative evidence on factors associated with adherence and of adherence-enhancing interventions. METHOD: A systematic review of computerised databases was carried out to identify quantitative studies of adherence in depression. Papers retained addressed unipolar depression and considered adherence as the primary end-point. RESULTS: Of studies published between 1973 and 1999, 32 met the review criteria: epidemiological descriptive studies (n=14): non-random comparisons of control and intervention groups (n=3); randomised interventions (n=14); and meta-analysis (n=1). Patient education and medication clinics were the interventions most commonly tested, combined with a variety of other interventions. CONCLUSIONS: The studies did not give consistent indications of which interventions may be effective. Carefully designed clinical trials are needed to clarify the effect of single and combined interventions.

Mental health care in Piedmont: a description of its structure and components using a new technology for service assessment.

OBJECTIVE: The northern-Italian region of Piedmont has a total population of 4.3 million. The regional territory is currently divided into 22 local health services, each serving a population not exceeding 300,000 and incorporating a Department of Mental Health. The organization of psychiatric assistance can be described as relatively stable and conforms with the standards imposed by national regulations. Drawing upon previous research experience, and with the support of the relevant regional authorities, our survey implements the methodology developed by the EPCAT team and will eventually embrace about 80% of all local health service areas in this region. METHODS: The survey was preceded by a number of preliminary steps including the training of four researchers, inter-rater reliability testing (particularly for the International Classification of Mental Health Care), and the adjustment of the methodology developed by the EPCAT team to facilitate understanding and use of the instrumentation by the psychiatric professionals involved in the data collection. RESULTS: This paper summarizes data on the structure and components of the mental health service in three areas of Piedmont, with special reference to structures funded by the National Health System. CONCLUSION: Overlooking the imbalances affecting both the resources available for different populations, and the operational profiles of psychiatric agencies of the same type, our data allow an assessment of the descriptive and comparative capabilities of the proposed methodology.

Effectiveness of antidepressants. Meta-analysis of dose-effect relationships in randomised clinical trials.

BACKGROUND: Antidepressant drugs are usually prescribed at low doses, possibly to avoid adverse reactions. No comprehensive review has addressed the issue of dose, clinical response and tolerability in a quantitative way. AIMS: To determine whether high doses of antidepressants are more effective than low doses, and how safety is affected by dose. METHOD: Trials comparing two or more doses of the same antidepressant were located, and all antidepressants administered were converted to the equivalent dose of imipramine. Generalised estimating equations were used to analyse percentage improvement and adverse event rate according to dose level. RESULTS: Thirty-three studies were identified. The dose level 100-200 mg imipramine equivalents showed an average improvement of 53% by 'intention-to-treat'. Higher doses were not accompanied by increased efficacy, while lower doses showed reduction in efficacy. Adverse events significantly increased with dose. CONCLUSIONS: With a low dose of antidepressants, clinicians trade off a slightly reduced chance of improvement for a higher chance of avoiding adverse reactions.

Increased sister chromatid exchange and chromosomal aberration frequencies in psychiatric patients receiving psychopharmacological therapy.

Combinations of various psychotropic drugs are often used, sometimes for long periods, in the treatment of various forms of psychiatric disorders. This paper evaluates the cytogenetic consequences of daily exposure to polytherapy with antianxiety, antipsychotic and antimaniacal drugs by determining chromosomal aberrations (CA) and sister chromatid exchange (SCE) in peripheral blood samples. The study was performed with a group of 36 psychiatric patients: 18 receiving long-term treatment with lithium carbonate, combined with benzodiazepines (BD) and antipsychotic agents (Group A) and 18 treated with BD and antipsychotics (Group B). Among the latter, 7 patients had only been treated for 1 month (Group B1). The results reveal a significant increase (p<0.01) in cells with aberrations in the two groups of patients (A,B) compared to controls. Moreover, complex aberrations (dicentrics, rearrangements, chromatid exchanges) had a frequency of 0.63% in patients receiving long-term treatment compared to 0.11% in controls, corresponding to the general spontaneous rate. The mean frequency of SCE/cell and the percentage of cells with a high frequency of exchanges (HFC) also showed a highly significant difference compared to controls in both Group A and Group B. Group B1 (patients who only commenced treatment 1 month earlier) did not differ from the control group with regard to the frequency and type of chromosomal aberration or in relation to the mean frequency of SCE/cell. No significant differences were detected between Groups A and B both of which showed similar frequencies of cells with aberrations, SCE/cell and HFC. No correlations were observed in Group A between lithemia and the biological markers studied.

Utilization of neuroleptic drugs in Italian mental health services: a survey in Piedmont.

OBJECTIVE: This survey describes neuroleptic prescribing practices in Italian mental health services 15 years after implementation of a mental health reform law that shifted the focus of care from mental hospitals to community services. METHODS: The authors conducted a cross-sectional survey of neuroleptic prescribing practices in several psychiatric services throughout the Piedmont region in northern Italy. The relationship between dosing patterns and patients' characteristics was assessed using multiple regression analysis. RESULTS: Sixty-six community mental health services and 14 psychiatric wards in general hospitals participated in the survey in 1991. Among the 3,823 psychiatric patients seen in these settings for whom survey data were available, 67 percent of outpatients and 84 percent of inpatients were prescribed neuroleptic drugs. Twenty-eight percent of outpatients and 45 percent of inpatients received more than one neuroleptic. The average daily dose of neuroleptics was low to moderate; 89 percent of outpatients and 67 percent of inpatients received 500 mg of chlorpromazine equivalents or less. The neuroleptic dose was significantly associated with patients' age, education, diagnosis, length of treatment, and receipt of polypharmacy. CONCLUSIONS: This survey confirms the low to moderate neuroleptic dosing in Italian mental health services, both in outpatient and inpatient settings. However, it also documents the widespread use of polypharmacy, a pattern that has remained largely unchanged over the past 15 years.

Prescription pattern of antidepressants in out-patient psychiatric practice.

The prescription pattern of antidepressants was reviewed in a large sample of psychiatric out-patients in the Region of Piedmont. Antidepressants were administered to 780 patients; most were diagnosed with mood disorders (62% of prescriptions) and anxiety disorders (34%), the rest with other diagnoses. The mean prescribed dose of antidepressants was at the lower end of, or below, the recommended range for out-patients, with the exception of amineptine and mianserin. The administered dose of tricyclic antidepressants was significantly associated with sex and diagnosis: female patients received a daily dose that was significantly lower than that for males, and patients with a diagnosis of mood disorders received significantly more medication than those with other diagnoses.