Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): study protocol for a cluster randomised controlled trial.

BACKGROUND: The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. METHODS: The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18-65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the 'empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders' (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. DISCUSSION: The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. TRIAL REGISTRATION: The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

Cost effectiveness of paliperidone palmitate for the treatment of schizophrenia in Germany.

BACKGROUND: Treatment with antipsychotic medication is an important element of relapse prevention in the management of schizophrenia, and can reduce inpatient stays. Recently, the long-acting atypical antipsychotic paliperidone long-acting injectable (PLAI), a once-monthly LAI antipsychotic, was approved for treatment of schizophrenia in Germany. OBJECTIVE: To estimate, based on a previously published model, the cost effectiveness of PLAI compared with other common antipsychotic treatment strategies in patients diagnosed with schizophrenia in Germany. METHODS: A Markov decision analytic model was adapted to the German healthcare system. The model considers the cost effectiveness for PLAI as a maintenance treatment for patients with schizophrenia from the payer perspective. The patients transition between eight health states on a monthly basis over a 5-year time horizon. As therapeutic strategies, PLAI, quetiapine, risperidone long-acting injections (RLAI), oral olanzapine, oral risperidone, zuclopenthixol decanoate, olanzapine long-acting injections (OLAI), oral typical and oral atypical were compared. Probability of relapse, level of adherence, side effects and treatment discontinuation were derived from the Swedish original model. Input factors regarding resource use and costs were estimated and adjusted for the German healthcare system. A probabilistic sensitivity analyses (PSA) using cost-effectiveness scatter plots was performed to visualize the robustness of the results. RESULTS: In base-case scenario, PLAI is superior to RLAI in gained quality-adjusted life-years (QALYs) and avoided relapses. Relative to all other treatment strategies, PLAI is more effective with regard to gained QALYs and avoided relapses but results in higher treatment costs over a 5-year horizon in base-case scenario. The results were tested in PSA. If a cost-effectiveness threshold of 30,000 is assumed, for example, PLAI can be considered to be cost effective compared with RLAI in about 92.5 % of cases regarding gained QALYs, and in 78.6 % of cases regarding avoided relapse. Compared with OLAI, in about 94.4 % of cases regarding gained QALYs and in 99.9 % of cases regarding avoided relapse, cost effectiveness can be considered. Comparing PLAI and zuclopenthixol decanoate, cost effectiveness can be assumed in about 90.4 % of cases regarding gained QALYs, and in all cases regarding avoided relapse. CONCLUSIONS: PLAI dominates RLAI and compared with the other treatment strategies PLAI has shown to be more effective but results in higher costs in base-case scenario.

Long-term observation of patients successfully switched to risperidone long-acting injectable: A retrospective, naturalistic 18-month mirror-image study of hospitalization rates and therapy costs.

Abstract Objective. The aim of the present 18-month retrospective study was to assess the association between a continuous long-term treatment with risperidone long-acting injectable (RLAI) of at least 12 months and in-patient care of patients suffering of schizophrenia or schizoaffective disorder. Furthermore we wanted to assess the cost-effectiveness of a long-term treatment with RLAI. Methods. In a mirror-image design, data of 119 patients with schizophrenia and schizoaffective disorder who were switched to RLAI treatment were analyzed retrospectively. Hospitalization rates, the duration of inpatient treatment and the overall treatment costs were assessed 12 and 18 months after switching to RLAI and compared to the equivalent time preceding the switch. Results. After 12 and 18 months of RLAI treatment, the mean reduction of inpatient care was 27.4 and 38.4 days per patient, respectively, compared to the equivalent time period prior to switching to RLAI (Wilcoxon P < 0.001). The overall savings in drug and institutional-care costs were 21.1 and 21.9%, respectively. Conclusions. Patients receiving RLAI for at least 12 months showed a reduction in inpatient days and lower overall treatment costs.

Identifying the profile of optimal candidates for antipsychotic depot therapy A cluster analysis.

OBJECTIVE: The prescription rate of antipsychotic depots for patients suffering from schizophrenia is currently low. Among these patients the assumable acceptance rate of depot as treatment of choice is markedly higher, but psychiatrists do report that patients frequently reject the offer of depot treatment. In a first step to highlight this contradiction we aimed at identifying attributes of patients that indicate their qualification for depot treatment in the eyes of the psychiatrists. METHOD: We surveyed 201 psychiatrists about their evaluation of patients' attributes potentially influencing their qualification for depot treatment. Multidimensional and cluster analyses were applied to detect associated attributes. A second sample of further 248 psychiatrists was asked about their proposal of depot treatment to patients depending on the number of relapses in the past. RESULTS: Two clusters of attributes were identified characterizing patients' qualification for depot treatment. In cluster I episodes of non-compliance and relapses in the past were considered as favoring the qualification. cluster II included a high level of insight, openness to drug treatment and profound knowledge about the disease representing attributes that increase patients' qualification. Patients were significantly more likely to be offered depot treatment after their fourth reexacerbation compared to their first relapse. CONCLUSIONS: Attributes comprised in cluster I highly qualify a patient for depot treatment which is in line with the current prescription stereotype. This conservative notion of depot use is supplemented by an alternative cluster II patient profile. Patients fitting this cluster also potentially qualify for depot treatment according to the surveyed psychiatrists and should be offered depot in clinical routine considering the advantages of this form of administration.

Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics.

OBJECTIVE: In many parts of the world, second-generation antipsychotics have largely replaced typical antipsychotics as the treatment of choice for schizophrenia. Consequently, trials comparing two drugs of this class--so-called head-to-head studies--are gaining in relevance. The authors reviewed results of head-to-head studies of second-generation antipsychotics funded by pharmaceutical companies to determine if a relationship existed between the sponsor of the trial and the drug favored in the study's overall outcome. METHOD: The authors identified head-to-head comparison studies of second-generation antipsychotics through a MEDLINE search for the period from 1966 to September 2003 and identified additional head-to-head studies from selected conference proceedings for the period from 1999 to February 2004. The abstracts of all studies fully or partly funded by pharmaceutical companies were modified to mask the names and doses of the drugs used in the trial, and two physicians blinded to the study sponsor reviewed the abstracts and independently rated which drug was favored by the overall outcome measures. Two authors who were not blinded to the study sponsor reviewed the entire report of each study for sources of bias that could have affected the results in favor of the sponsor's drug. RESULTS: Of the 42 reports identified by the authors, 33 were sponsored by a pharmaceutical company. In 90.0% of the studies, the reported overall outcome was in favor of the sponsor's drug. This pattern resulted in contradictory conclusions across studies when the findings of studies of the same drugs but with different sponsors were compared. Potential sources of bias occurred in the areas of doses and dose escalation, study entry criteria and study populations, statistics and methods, and reporting of results and wording of findings. CONCLUSIONS: Some sources of bias may limit the validity of head-to-head comparison studies of second-generation antipsychotics. Because most of the sources of bias identified in this review were subtle rather than compelling, the clinical usefulness of future trials may benefit from minor modifications to help avoid bias. The authors make a number of concrete suggestions for ways in which potential sources of bias can be addressed by study initiators, peer reviewers of studies under consideration for publication, and readers of published studies.