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Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.

ABSTRACT: Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived.Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment) versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS) score ? 16 and global assessment of function (GAF) ? 60 after ? 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis including the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study.This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance to decisions on commissioning, service provision and implementation.

SUBMITTER: Morriss R

PROVIDER: S-EPMC3001706 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.

Morriss Richard R Marttunnen Sarah S Garland Anne A Nixon Neil N McDonald Ruth R Sweeney Tim T Flambert Heather H Fox Richard R Kaylor-Hughes Catherine C James Marilyn M Yang Min M

BMC psychiatry 20101129

<h4>Background</h4>Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algori ...[more]

PMID: 21114826

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Project description:BackgroundLittle is known on whether centralised and specialised combined pharmacological and psychological intervention in the early phase of severe unipolar depression improve prognosis. The aim of the present study was to assess the benefits and harms of centralised and specialised secondary care intervention in the early course of severe unipolar depression.MethodsA randomised multicentre trial with central randomisation and blinding in relation to the primary outcome comparing a centralised and specialised outpatient intervention program with standard decentralised psychiatric treatment. The interventions were offered at discharge from first, second, or third hospitalisation due to a single depressive episode or recurrent depressive disorder. The primary outcome was time to readmission to psychiatric hospital. The data on re-hospitalisation was obtained from the Danish Psychiatric Central Register. The secondary and tertiary outcomes were severity of depressive symptoms according to the Major Depression Inventory, adherence to medical treatment, and satisfaction with treatment according to the total score on the Verona Service Satisfaction Scale-Affective Disorder (VSSS-A). These outcomes were assessed using questionnaires one year after discharge from hospital.ResultsA total of 268 patients with unipolar depression were included. There was no significant difference in the time to readmission (unadjusted hazard ratio 0.89, 95% confidence interval 0.60 to 1.32; log rank: χ(2) = 0.3, d.f. = 1, p = 0.6); severity of depressive symptoms (mood disorder clinic: median 21.6, quartiles 9.7-31.2 versus standard treatment: median 20.2, quartiles 10.0-29.8; p = 0.7); or the prevalence of patients in antidepressant treatment (73.9% versus 80.0%, p = 0.2). Centralised and specialised secondary care intervention resulted in significantly higher satisfaction with treatment (131 (SD 31.8) versus 107 (SD 25.6); p<0.001).ConclusionsCentralised and specialised secondary care intervention in the early course of severe unipolar depression resulted in no significant effects on time to rehospitalisation, severity of symptoms, or use of antidepressants, but increased patient satisfaction.Trial registrationClinicalTrials.gov NCT00253071.

Project description:IntroductionMajor depressive disorder (MDD) affects more than 264 million people worldwide and is associated with an impaired quality of life as well as a higher risk of mortality. Current routine treatments demonstrate limited effectiveness. Light therapy (LT) on its own or in combination with antidepressant treatments could be an effective treatment, but the use of conventional LT devices use is restrictive. Portable LT devices allow patients to continue with their day-to-day activities and therefore encourage better treatment compliance. They have not been evaluated in MDD.Methods and analysisThe study is a single-centre, double-blind, randomised controlled trial assessing the efficacy of LT delivered via a portable device in addition to usual care (medical care and drug treatment) for inpatients and outpatients with unipolar non-seasonal MDD. Over the course of 8 weeks, patients use the device daily for 30 min at medium intensity as soon as possible after waking up and preferably between 07:00 and 09:00. All patients continue their usual care with their referring physician. N=50 patients with MDD are included. The primary outcome measure is depressive symptom severity assessed using the Montgomery-Åsberg Depression Rating Scale between baseline and the eighth week. Secondary outcome measures are sleep quality assessed using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale and anxiety level assessed on the Hamilton Anxiety Rating Scale, between baseline and week 8. Further parameters relating to cognitive function are measured at baseline and after the intervention. An ancillary study aims to evaluate the impact of MDD on the retina and to follow its progression. Main limitations include risk of discontinuation or non-adherence and bias in patient selection.Ethics and disseminationThe study protocol was approved by Ile de France X's Ethics Committee (protocol number 34-2018). Findings will be published in peer-reviewed journals.Trial registration numberNCT03685942.

Project description:BackgroundMore than half of all heart disease and stroke are attributable to hypertension, which is associated with approximately 10% of direct medical costs globally. Clinical trial evidence has demonstrated that the benefits of pharmacist intervention, including education, consultation and/or prescribing, can help to reduce blood pressure; a recent Canadian trial found an 18.3 mmHg reduction in systolic blood pressure associated with pharmacist care and prescribing. The objective of this study was to evaluate the economic impact of such an intervention in a Canadian setting.MethodsA Markov cost-effectiveness model was developed to extrapolate potential differences in long-term cardiovascular and renal disease outcomes, using Framingham risk equations and other published risk equations. A range of values for systolic blood pressure reduction was considered (7.6-18.3 mmHg) to reflect the range of potential interventions and available evidence. The model incorporated health outcomes, costs and quality of life to estimate an overall incremental cost-effectiveness ratio. Costs considered included direct medical costs as well as the costs associated with implementing the pharmacist intervention strategy.ResultsFor a systolic blood pressure reduction of 18.3 mmHg, the estimated impact is 0.21 fewer cardiovascular events per person and, discounted at 5% per year, 0.3 additional life-years, 0.4 additional quality-adjusted life-years and $6,364 cost savings over a lifetime. Thus, the intervention is economically dominant, being both more effective and cost-saving relative to usual care.DiscussionAcross a range of one-way and probabilistic sensitivity analyses of key parameters and assumptions, pharmacist intervention remained both effective and cost-saving.ConclusionComprehensive pharmacist care of hypertension, including patient education and prescribing, has the potential to offer both health benefits and cost savings to Canadians and, as such, has important public health implications.

Project description:ImportanceWait times for autism spectrum disorder (ASD) diagnosis are lengthy because of inadequate supply of specialist teams. General pediatricians may be able to diagnose some cases of ASD, thereby reducing wait times.ObjectiveTo determine the accuracy of ASD diagnostic assessments conducted by general pediatricians compared with a multidisciplinary team (MDT).Design, setting, and participantsThis prospective diagnostic study was conducted in and a specialist assessment center in Toronto, Ontario, Canada, and Ontario general pediatrician practices from June 2016 to March 2020. Children were younger than 5.5 years, referred with a developmental concern, and without an existing ASD diagnosis. Data analysis was performed from October 2021 to February 2022.ExposuresThe pediatrician and MDT each conducted blinded assessments and recorded a decision as to whether the child had ASD.Main outcomes and measuresMain outcomes included sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). A logistic regression was performed to identify factors associated with accurate pediatrician assessment for children with or without an ASD diagnosis.ResultsSeventeen pediatricians (12 women [71%]) participated in the study and referred 106 children (79 boys [75%]; mean [SD] age, 41.9 [13.3] months). Sixty participants (57%) were from minoritized racial and ethnic groups (eg, Black, Asian, Hispanic, Middle Eastern, and multiracial). Seventy-two participants (68%) received a diagnosis of ASD by the MDT. Sensitivity and specificity of the pediatrician assessments compared with MDT were 0.75 (95% CI, 0.67-0.83) and 0.79 (95% CI, 0.62-0.91), respectively. The PPV of the pediatrician assessments was 0.89 (95% CI, 0.80-0.94) (ie, 89% agreement with the MDT), and NPV was 0.60 (95% CI, 0.49-0.70) (ie, 60% agreement with the MDT). Higher pediatrician certainty (odds ratio [OR], 3.33; 95% CI, 1.71-7.34; P = .001) was associated with increased diagnostic accuracy for children with ASD. Lower accuracy was seen for children with higher Visual Reception subscale developmental skills (OR, 0.93; 95% CI, 0.89-0.97; P = .001), speaking abilities (OR, 0.17; 95% CI, 0.03-0.67; P = .03), and White race (OR, 0.32; 95% CI, 0.10-0.97; P = .04). Age, gender, and Autism Diagnostic Observation Schedule, 2nd Edition composite scores were not significantly associated with the accuracy of assessments. All 7 children with a sibling with ASD received an accurate diagnosis; otherwise, no significant factors were identified for accuracy in children without ASD.Conclusions and relevanceThis study of concordance of autism assessment between pediatricians and an expert MDT in young children found high accuracy when general pediatricians felt confident and lower accuracy when ruling out ASD. These findings suggest that children with co-occurring delays may be potential candidates for community assessment.

Project description:BackgroundPrimary care is the main treatment setting for panic disorder and should be supplemented by collaborative care programs. However, shortage of mental health professionals prevents collaborative care programs from being effectively implemented. The PARADISE study showed the efficacy of a self-managed, cognitive-behavioural therapy (CBT)-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the family practice team.ObjectiveTo assess the cost-effectiveness of the PARADISE intervention.DesignCost-effectiveness analysis from the societal perspective based on data from a cluster-randomized controlled trial over a time horizon of 12 months.ParticipantsFour hundred nineteen adult panic disorder patients with or without agoraphobia.InterventionsA self-managed, CBT-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the primary care practice team in comparison to routine care.Main measuresTotal costs from the societal perspective. Direct costs and disease-specific costs. Quality-adjusted life years based on the EQ-5D-3L. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.Key resultsPatients in the intervention group caused lower costs (mean, €1017; 95% confidence interval [-€3306; €1272]; p = 0.38) and gained on average more QALY (mean, 0.034 QALY (95% confidence interval [0.005; 0.062]; p = 0.02). Therefore, the intervention dominated the control treatment. The probability of cost-effectiveness of the intervention at a willingness-to-pay margin of €50,000 per QALY was 96%. Results from supplementary analyses considering direct or disease-specific costs instead of total costs showed comparable results.ConclusionThe PARADISE intervention is cost effective. This conclusion is valid for total costs, generic health care (direct) costs, disease-specific health care costs.Trial registrationGerman Clinical Trials Register: DRKS00004386 Current Controlled Trials: ISRCTN64669297.

Project description:ObjectiveThe objective of this study was to assess the cost effectiveness of commonly used antidepressants as first-line treatment of major depressive disorder (MDD) in Belgium.MethodsThe model structure was based on a decision tree developed by the Swedish TLV (Tandvårds- och läkemedelsförmånsverket) and adapted to the Belgium healthcare setting, using primary local data on the patterns of treatment and following KCE [Federal Knowledge Center (Federaal Kenniscentrum voor de Gezondheidszorg)] recommendations. Comparators were escitalopram, citalopram, fluoxetine, paroxetine, sertraline, duloxetine, venlafaxine, and mirtazapine. In the model, patients not achieving remission or relapsing after remission on the assessed treatment moved to a second therapeutic step (titration, switch, add-on, or transfer to a specialist). In case of failure in the second step or following a suicide attempt, patients were assumed to be referred to secondary care. The time horizon was 1 year and the analysis was conducted from the National Institute for Health and Disability Insurance (NIHDI; national health insurance) and societal perspectives. Remission rates were obtained from the TLV network meta-analysis and risk of relapse, efficacy following therapeutic change, risk of suicide attempts and related death, utilities, costs (2012), and resources were derived from the published literature and expert opinion. The effect of uncertainty in model parameters was estimated through scenario analyses and a probabilistic sensitivity analysis (PSA).ResultsIn the base-case analysis, escitalopram was identified as the optimal strategy: it dominated all other treatments except venlafaxine from the NIHDI perspective, against which it was cost effective with an incremental cost-effectiveness ratio of <euro>6,352 per quality-adjusted life-year (QALY). Escitalopram also dominated all other treatments from the societal perspective. At a threshold of <euro>30,000 per QALY and from the NIHDI perspective, the PSA showed that the probability of escitalopram being identified as the optimal strategy ranged from 61 % (vs. venlafaxine) to 100 % (vs. fluoxetine).ConclusionEscitalopram was associated with the highest probability of being the optimal treatment from the NIHDI and societal perspectives. This analysis, based on new Belgian clinical practice data and following KCE requirements, provides additional information that may be used to guide the choice of treatments in the management of MDD in Belgium.

Dataset Information

Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.

Publications

Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.

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