Impact of clinical decision-making participation and satisfaction on outcomes in mental health practice: results from the CEDAR European longitudinal study.

The present study aimed to assess: (1) whether a more active involvement of patients is associated with an improvement of clinical symptoms, global functioning, and quality-of-life; and (2) how patients' satisfaction with clinical decisions can lead to better outcome after 1 year. Data were collected as part of the study 'Clinical decision-making and outcome in routine care for people with severe mental illness (CEDAR)', a longitudinal observational study, funded by the European Commission and carried out in six European countries. Patients' inclusion criteria were: (a) aged between 18 and 60 years; (b) diagnosis of a severe mental illness of any kind according to the Threshold Assessment Grid (TAG) ≥ 5 and duration of illness ≥ 2 years; (c) expected contact with the local mental health service during the 12-month observation period; (d) adequate skills in the language of the host countries; and (e) the ability to provide written informed consent. The clinical decision-making styles of clinicians and the patient satisfaction with decisions were assessed using the Clinical Decision Making Style and the Clinical Decision Making Involvement and Satisfaction scales, respectively. Patients were assessed at baseline and 1 year after the recruitment. The sample consisted of 588 patients with severe mental illness, mainly female, with a mean age of 41.69 (±10.74) and a mean duration of illness of 12.5 (±9.27) years. The majority of patients were diagnosed with psychotic (45.75%) or affective disorders (34.01%). At baseline, a shared CDM style was preferred by 70.6% of clinicians and about 40% of patients indicated a high level of satisfaction with the decision and 31% a medium level of satisfaction. Higher participation in clinical decisions was associated with improved social functioning and quality-of-life, and reduced interpersonal conflicts, sense of loneliness, feelings of inadequacy, and withdrawal in friendships after 1 year (p < 0.05). Moreover, a higher satisfaction with decisions was associated with a better quality-of-life (p < 0.0001), reduced symptom severity (p < 0.0001), and a significantly lower illness burden associated with symptoms of distress (p < 0.0001), interpersonal difficulties (p < 0.0001), and problems in social roles (p < 0.05). Our findings clearly show that a higher involvement in and satisfaction of patients with clinical decision-making was associated with better outcomes. More efforts have to be made to increase the involvement of patients in clinical decision-making in routine care settings.

The message of the survival curves: I. Composite analysis of long-term treatment studies in bipolar disorder.

RATIONALE: There is a shortage of studies analyzing the time course of recurrent episodes and comparing effectiveness of long-term treatments in bipolar disorder. 'Number needed to treat' (NNT) analyses have been proven to be useful for clinically meaningful comparisons, but results vary considerably among studies. The survival curves of different trials also show a great variability preventing reliable conclusions on the time course of maintenance therapies. The variance of survival analyses on long-term medication management can be reduced with increasing the statistical power by combining the life-tables of individual studies. METHODS: In this study the survival tables of 28 studies on maintenance treatment of bipolar disorder were reconstructed from the published diagrams, and the numbers of relapsed patients in the original studies were estimated for plotting composite survival curves of an inactive, mono- and combination therapy arm. The review was finally based on 5231 subjects. RESULTS: The resulting composite diagrams indicate that within the first year 48% of patients on monotherapy, and 35% on combination therapy experienced recurrence of any affective episode ('early relapsers'). The rest of the patient population was affected by recurrences in a smaller rate over a more extended period of time ('late relapsers'). For a favorable outcome at 40 months of episode prevention in bipolar disorder the NNT was 6 for mono- and 3 for combination therapy. Log-rank analyses of the composite data supported the effectiveness of both medication protocols over placebo, and the superiority of drug combination over monotherapy; though there were some indications of decreased efficacy in the two treatment arms after extended maintenance. CONCLUSIONS: Composite analysis offers increased statistical power for studying the time course of survival data. Mood episodes in bipolar disorder are likely to recur early on and relapses in "real-life" can be more frequent than the rates published here. Our results favor combination therapy for the long-term management of bipolar disorder. Concerns are expressed that NNT analyses have significant limitations when applied to recurring events with cumulative deterioration instead of cases where cumulative improvement is expected over time.

Pathogenic D76N Variant of ß2-Microglobulin: Synergy of Diverse Effects in Both the Native and Amyloid States.

ß2-microglobulin (ß2m), the light chain of the MHC-I complex, is associated with dialysis-related amyloidosis (DRA). Recently, a hereditary systemic amyloidosis was discovered, caused by a naturally occurring D76N ß2m variant, which showed a structure remarkably similar to the wild-type (WT) protein, albeit with decreased thermodynamic stability and increased amyloidogenicity. Here, we investigated the role of the D76N mutation in the amyloid formation of ß2m by point mutations affecting the Asp76-Lys41 ion-pair of WT ß2m and the charge cluster on Asp38. Using a variety of biophysical techniques, we investigated the conformational stability and partial unfolding of the native state of the variants, as well as their amyloidogenic propensity and the stability of amyloid fibrils under various conditions. Furthermore, we studied the intermolecular interactions of WT and mutant proteins with various binding partners that might have in vivo relevance. We found that, relative to WT ß2m, the exceptional amyloidogenicity of the pathogenic D76N ß2m variant is realized by the deleterious synergy of diverse effects of destabilized native structure, higher sensitivity to negatively charged amphiphilic molecules (e.g., lipids) and polyphosphate, more effective fibril nucleation, higher conformational stability of fibrils, and elevated affinity for extracellular components, including extracellular matrix proteins.

Effects of Clinical Decision Topic on Patients' Involvement in and Satisfaction With Decisions and Their Subsequent Implementation.

OBJECTIVE: Clinical decision making is an important aspect of mental health care. Predictors of how patients experience decision making and whether decisions are implemented are underresearched. This study investigated the relationship between decision topic and involvement in the decision, satisfaction with it, and its subsequent implementation from both staff and patient perspectives. METHODS: As part of the Clinical Decision Making and Outcome in Routine Care for People With Severe Mental Illness study, patients (N=588) and their providers (N=213) were recruited from community-based mental health services in six European countries. Both completed bimonthly assessments for one year using the Clinical Decision Making in Routine Care Scale to assess the decision topic and implementation; both also completed the Clinical Decision Making Involvement and Satisfaction Scale. RESULTS: Three categories of decision topics were determined: treatment (most frequently cited), social, and financial. The topic identified as most important remained stable over the follow-up. Patients were more likely to rate their involvement as active rather than passive for social decisions (odds ratio [OR]=5.7, p<.001) and financial decisions (OR=9.5, p<.001). They were more likely to report higher levels of satisfaction rather than lower levels for social decisions (OR=1.5, p=.01) and financial decisions (OR=1.7, p=.01). Social decisions were more likely to be partly implemented (OR=3.0, p<.001) or fully implemented (OR=1.7, p=.03) than not implemented. CONCLUSIONS: Patients reported poorer involvement, satisfaction, and implementation in regard to treatment-related decisions, compared with social and financial decisions. Clinicians may need to employ different interactional styles for different types of decisions to maximize satisfaction and decision implementation.