92 research outputs found
Effectiveness and cost-effectiveness of self-help plus (sh+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: Study protocols for two randomised controlled trials
Introduction This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey. Methods and analysis Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (â„3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness. Ethics and dissemination The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings. Trials registration numbers NCT03571347, NCT03587896
Factors associated with first- versus second generation long-acting antipsychotics prescribed un-der ordinary clinical practice in Italy.
Background For many years, long-acting intramuscular (LAI) antipsychotics have been prescribed predominantly to chronic and severe patients, as a last resort when other treatments failed. Recently, a broader and earlier use of LAIs, particularly second-generation LAIs, has been emphasized. To date, few studies attempted to frame how this change in prescribing took place in real-world practice. Therefore, this study aimed to describe the clinical features of patients prescribed with LAIs, and to explore possible prescribing differences between first- and second-generations LAIs under ordinary clinical practice in Italy. Methods The STAR Network \u201cDepot\u201d Study is an observational, longitudinal, multicenter study involving 35 centers in Italy. In the cross-sectional phase, patients prescribed with LAIs were consecutively recruited and assessed over a period of 12 months. Descriptive statistics and multivariable logistic regression analyses were employed. Results Of the 451 recruited patients, 61% were males. The level of social and working functioning was heterogeneous, as was the severity of disease. Seventy-two per cent of the patients had a diagnosis of the schizophrenia spectrum. Seventy per cent were prescribed with second-generation antipsychotic (SGA) LAIs (mostly paliperidone, aripiprazole and risperidone). Compared to first-generation antipsychotic (FGA) LAIs, patients prescribed with SGA LAIs were more often younger; employed; with a diagnosis of the schizophrenia spectrum or bipolar disorder; with higher levels of affective symptoms; with fewer LAI prescriptions in the past. Discussion LAIs' prescribing practices appear to be more flexible as compared to the past, although this change is mostly restricted to SGA LAI
Combinations of QT-prolonging drugs: towards disentangling pharmacokinetic and pharmaco-dynamic effects in their potentially additive nature.
Background: Whether arrhythmia risks will increase if drugs with electrocardiographic (ECG)
QT-prolonging properties are combined is generally supposed but not well studied. Based on
available evidence, the Arizona Center for Education and Research on Therapeutics (AZCERT)
classification defines the risk of QT prolongation for exposure to single drugs. We aimed to
investigate how combining AZCERT drug categories impacts QT duration and how relative drug
exposure affects the extent of pharmacodynamic drugâdrug interactions.
Methods: In a cohort of 2558 psychiatric inpatients and outpatients, we modeled whether
AZCERT class and number of coprescribed QT-prolonging drugs correlates with observed
rate-corrected QT duration (QTc) while also considering age, sex, inpatient status, and other
QTc-prolonging risk factors. We concurrently considered administered drug doses and
pharmacokinetic interactions modulating drug clearance to calculate individual weights of
relative exposure with AZCERT drugs. Because QTc duration is concentration-dependent, we
estimated individual drug exposure with these drugs and included this information as weights
in weighted regression analyses.
Results: Drugs attributing a âknownâ risk for clinical consequences were associated with the
largest QTc prolongations. However, the presence of at least two versus one QTc-prolonging
drug yielded nonsignificant prolongations [exposure-weighted parameter estimates with
95% confidence intervals for âknownâ risk drugs + 0.93 ms (â8.88;10.75)]. Estimates for
the âconditionalâ risk class increased upon refinement with relative drug exposure and coadministration of a âknownâ risk drug as a further risk factor.
Conclusions: These observations indicate that indiscriminate combinations of QTc-prolonging
drugs do not necessarily result in additive QTc prolongation and suggest that QT prolongation
caused by drug combinations strongly depends on the nature of the combination partners and
individual drug exposure. Concurrently, it stresses the value of the AZCERT classification also
for the risk prediction of combination therapies with QT-prolonging drugs
Effectiveness and cost-effectiveness of Self-Help Plus (SH plus ) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials
Introduction: This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.Methods and analysis: Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (â„3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+orâto enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6âmonth follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness.Ethics and dissemination: The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings.</p
Offâlabel long acting injectable antipsychotics in realâworld clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study
Introduction: Information on the offâlabel use of LongâActing Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with onâ vs offâlabel LAIs and predictors of offâlabel Firstâ or SecondâGeneration Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method: In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on offâ or onâlabel prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the offâlabel group. Results: SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their onâ and offâlabel use. Approximately 1 in 4 patients received an offâlabel prescription. In the offâlabel group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion: Our study is the first to identify predictors of FGA vs SGA choice in patients treated with offâlabel LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use coâmorbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns
Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study
Background: Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective: Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods: The STAR Network âDepot Studyâ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results: The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4â44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3â43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4â84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6â40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6â27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742â0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003â4.634; p = 0.049). Conclusions: Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation
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