Alberto Parabiaghi

Assessing reliable and clinically significant change on Health of the Nation Outcome Scales: method for displaying longitudinal data

OBJECTIVE Many authors recommended that reliable and clinically significant change (RCSC) should be calculated when reporting results of interventions. To test the reliability of the Health of the Nation Outcome Scales (HoNOS) in identifying RCSC, we applied the Jacobson and Truax model to two HoNOS assessments in a large group of people evaluated in 10 community mental health services in Lombardy, Italy, in 2000. METHOD The HoNOS was administered to 9817 patients; of these, 4759 (48%) were re-assessed. Reliable change (RC) was calculated using Cronbachs alpha (alpha), as a parameter of the reliability of the measure. Clinical significance cut-offs were calculated using a classification of severity based on HoNOS items. RESULTS In the whole sample, the clinical improvement cut-off was 11 and the remission cut-off was 5. Considering the severe patients, the clinical improvement cut-off was 12. The RC index calculated on the whole group and on the subgroup of severe patients indicated that eight-point and seven-point changes, respectively, were needed to be confident that a real change had occurred. Longitudinal changes were depicted on two-dimensional graphs as examples of reporting RCSC on HoNOS total scores in a routine data collection: 91.6% of the whole sample (4361) was stable, 5.6% (269) improved and 1.8% (129) worsened. CONCLUSION Our study proposes a methodological framework for computing RCSC normative data on a widely used outcome scale and for identifying different degrees of clinical change.

Measuring clinical change in routine mental health care: differences between first time and longer term service users

Objective: The aims were to assess the feasibility of routinely collecting outcome data in everyday mental health services across Italy and to evaluate clinical change in a cohort of patients stratified by illness duration. Method: A prevalence sample of patients attending nine Italian community mental health services (CMHS) was assessed over one year with the Health of the Nation Outcome Scales (HoNOS). The patients were classified on the basis of the duration of their contact with services. Clinical outcome was evaluated taking into account parameters of reliable and clinically significant change (RCSC). Predictors of change included clinical and socio-demographic characteristics at first assessment and six month reliable improvement. Results: 2059 patients were evaluated with only 3% attrition at follow up; 22% of first time and about 7% of longer term users achieved reliable improvement at one year. First contacts had a better outcome than longer term users and significant differences were seen at both group and individual level. Reliable improvement at six months was the best predictor of clinical improvement at one year for the whole cohort. Conclusion: The study demonstrated the feasibility of routine outcome assessment and gave an expected and realistic picture of the one-year outcome of a representative sample of patients attending a group of Italian CMHS. RCSC showed potential utility as a means of communicating with clinicians and decision makers.

Reducing Delusional Conviction through a Cognitive-Based Group Training Game: A Multicentre Randomized Controlled Trial

Objective “Michael’s game” (MG) is a card game targeting the ability to generate alternative hypotheses to explain a given experience. The main objective was to evaluate the effect of MG on delusional conviction as measured by the primary study outcome: the change in scores on the conviction subscale of the Peters delusions inventory (PDI-21). Other variables of interest were the change in scores on the distress and preoccupation subscales of the PDI-21, the brief psychiatric rating scale, the Beck cognitive insight scale, and belief flexibility assessed with the Maudsley assessment of delusions schedule (MADS). Methods We performed a parallel, assessor-blinded, randomized controlled superiority trial comparing treatment as usual plus participation in MG with treatment as usual plus being on a waiting list (TAU) in a sample of adult outpatients with psychotic disorders and persistent positive psychotic symptoms at inclusion. Results The 172 participants were randomized, with 86 included in each study arm. Assessments were performed at inclusion (T1: baseline), at 3 months (T2: post-treatment), and at 6 months after the second assessment (T3: follow-up). At T2, a positive treatment effect was observed on the primary outcome, the PDI-21 conviction subscale (p = 0.005). At T3, a sustained effect was observed for the conviction subscale (p = 0.002). Further effects were also observed at T3 on the PDI-21 distress (p = 0.002) and preoccupation subscales (p = 0.001), as well as on one of the MADS measures of belief flexibility (“anything against the belief”) (p = 0.001). Conclusion The study demonstrated some significant beneficial effect of MG.

Do patients improve after short psychiatric admission? A cohort study in Italy

Background: Information on outcomes of acute inpatient care in routine psychiatric practice is scant. In particular, it is uncertain to what extent short hospitalization can produce clinically meaningful changes. Aim: Our aim was to estimate the symptomatic outcome in a representative sample of patients admitted for short treatment to general hospital psychiatric units in Italy. Methods: Patients were assessed at admission and discharge using 24-item Brief Psychiatric Rating Scale (BPRS). Reliable change index was calculated to estimate the proportion of change attributable to measurement error and a cut-off score of 38 was adopted to identify the patients who showed clinically significant change. Results: Average length of stay was 5.7 days. Mean BPRS score dropped from 53.2 on admission to 41.5 at discharge, showing statistically significant improvement with an effect size of 0.80. However, reliable change was achieved by 24.7% of patients and clinically meaningful change by 13.6%. Conclusions: Reliance on statistical significance and effect size overestimates treatment effects, whereas reliable and clinically significant change index provides a conservative way to assess outcome. Few patients showed relevant improvement after a brief admission.

Do people with bipolar disorders have access to psychosocial treatments? A survey in Italy

Background: Several guidelines consider psychosocial treatments an essential component of clinical management of bipolar disorders in addition to drug therapy. However, to what extent such interventions are available in everyday practice to the average patient attending mental health services is not known. Aims: This study aims to investigate access of people with bipolar disorders to psychosocial treatments in a community-based care system. Method: Information on care delivery and service utilization were retrieved from the psychiatric database of Lombardy, Italy, covering a population of 9,743,000, for all adults who had at least one contact in 2009 with psychiatric services. Rates of patients with a diagnosis of bipolar disorder who had access to individual psychotherapy, couple/family therapy, group psychotherapy and family interventions were calculated and compared to patients with schizophrenia and depression. Results: A total of 8,899 subjects with bipolar disorder had been in contact with psychiatric services, corresponding to a treated annual prevalence rate of 1.1‰. More than 80% of patients were treated in community settings. Rates of patients receiving structured psychosocial treatments ranged from 0.7% for couple/family therapy to 6.1% for individual psychotherapy. No differences with patients with schizophrenia and depression were found. Patients with schizophrenia received more interventions labeled as rehabilitation. Conclusion: Few people with bipolar disorders had access to psychosocial treatments. Even in a well-developed system of community care, offer of psychosocial interventions for bipolar disorders is inadequate. This issue should be a target for future research on dissemination and implementation strategies.

The GiSAS study: Rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia☆

Given the controversy about the comparative efficacy of first- compared with second-generation antipsychotics in the treatment of schizophrenia, more large-scale evidence is needed to guide clinicians in their prescriptions. Most randomized controlled trials (RCTs) were conducted in centers of excellence on highly selected samples, poorly representative of real-world patients, and often suffered conflicts of interest as they were sponsored by drug companies. The primary aim of the present study is to compare the effectiveness of haloperidol, olanzapine and aripiprazole in a representative sample of schizophrenia patients. The GiSAS trial is an open-label, independent, pragmatic RCT in Italian community-based public psychiatric services. At least 260 patients meeting the DSM-IV criteria for schizophrenia will be randomly allocated to one of the study drugs and followed up for one year. A two-year observational phase will follow. The primary outcome for tolerability will be the onset of metabolic syndrome. The primary endpoint for effectiveness will be discontinuation of antipsychotic monotherapy. Secondary measures include global functioning, time to discontinuation due to side-effects, change of lipid profile, extrapyramidal symptoms and other adverse effects. In the last four years, the GiSAS study group has been working to implement this multicenter RCT. The trial mechanism is now fully functional and working. As of end of February 2011, 260 subjects were randomized by 54 study investigators in 33 out of 43 participating centers.

Conoscenze e cultura dell’uso degli psicofarmaci: che cosa si deposita nelle strategie di utilizzo degli psicofarmaci nei servizi di salute mentale?

Vengono rivisti diversi argomenti che influenzano il modo di studiare gli effetti degli psicofarmaci e di utilizzarli nei servizi di salute mentale. In Italia, parallelamente alla stabilizzazione di un ampio utilizzo di tutti gli psicofarmaci, nella ricerca crescono i dubbi sulla loro efficacia e si fa piu oscura la relazione tra meccanismi dell’effetto dei farmaci e meccanismo eziologico della malattia. La possibilita di un utilizzo meno massiccio e piu personalizzato degli psicofarmaci e al vaglio e risponde alla necessita di un uso piu consapevole da parte del medico e dell’utente. Interventi psicosociali utili ad un’assunzione regolare e consapevole sono poco forniti, e gli utenti si autoorganizzano per migliorare l’adesione alla terapia farmacologica. Nonostante la crescente evidenza empirica dei dubbi che accompagnano le certezze sugli psicofarmaci, questi rimangono centrali nel trattamento delle malattie mentali gravi per una serie di ragioni, tra cui la loro efficacia in importanti aspetti della malattia. Nell’insegnamento accademico, la competenza nell’associare farmaci a sintomi puo non accompagnarsi alla competenza nella progettazione di interventi complessi e articolati, anch’essa tecnica, e propria dell’operatore della salute mentale. Sembra necessario che il sapere degli esperti si apra alle richieste che vengono dagli utenti stessi e di chi dubita degli strumenti della psichiatria.

P01-255 - Do patients with bipolar disorders receive evidence-based psychosocial interventions? a survey in Italy

Introduction Research evidence on bipolar disorder supports the importance of patients’ active role to improve outcome and the efficacy of a number of psychosocial interventions. The lower cost and potential ease of dissemination of group psychoeducation suggest that this should be a first line approach, with more complex interventions, requiring highly specialized skills, reserved to selected patients. However, to what extent research models can be transferred to everyday practice remains to be seen. Objectives To explore the delivery of psychosocial interventions to bipolar disorders patients in routine mental health care. Aims To estimate the treated prevalence of bipolar disorders in Milan and to collect data about the variety of psychosocial interventions patients received by mental health services. Methods A survey of psychosocial interventions received by bipolar patients in three mental health services of Milan (catchment area 867,000 inhabitants) was conducted in 2009. Data from the Regional Mental Health Information System were retrieved to calculate the number of patients involved in psychosocial interventions and the kind of intervention provided. Results The treated prevalence rate was low, showing a probable treatment gap. Only 20% of 636 bipolar patients received at least one psychosocial intervention. The interventions provided were: family psychoeducation (3,8%), individual social skills training (11,5%), group social skills training (1,4%), and relatives group (3,0%). Conclusions Few bipolar patients receive psychosocial interventions in the MHS of Milan. Moreover, the interventions received were not specifically designed for bipolar disorder. Treatment gap could be reduced providing psychoeducation especially designed for bipolar patients.