Background Whole disease models (WDM) are large-scale, system-level models which can evaluate multiple decision questions across an entire care pathway. Whilst this type of model can offer several ...advantages as a platform for undertaking economic analyses, the availability and quality of existing WDMs is unknown. Objectives This systematic review aimed to identify existing WDMs to explore which disease areas they cover, to critically assess the quality of these models and provide recommendations for future research. Methods An electronic search was performed on multiple databases (MEDLINE, EMBASE, the NHS Economic Evaluation Database and the Health Technology Assessment database) on 23rd July 2023. Two independent reviewers selected studies for inclusion. Study quality was assessed using the National Institute for Health and Care Excellence (NICE) appraisal checklist for economic evaluations. Model characteristics were descriptively summarised. Results Forty-four WDMs were identified, of which thirty-two were developed after 2010. The main disease areas covered by existing WDMs are heart disease, cancer, acquired immune deficiency syndrome and metabolic disease. The quality of included WDMs is generally low. Common limitations included failure to consider the harms and costs of adverse events (AEs) of interventions, lack of probabilistic sensitivity analysis (PSA) and poor reporting. Conclusions There has been an increase in the number of WDMs since 2010. However, their quality is generally low which means they may require significant modification before they could be re-used, such as modelling AEs of interventions and incorporation of PSA. Sufficient details of the WDMs need to be reported to allow future reuse/adaptation.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Use of cost-effectiveness acceptability curves, as a method for summarising information on uncertainty cost-effectiveness, has become widespread within applied studies. This includes several studies ...in the mental health field. This editorial uses examples from recent papers to illustrate how cost effectiveness acceptability curves are constructed, what they represent and how they should be interpreted.
Summary Background Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is ...complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. Methods In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19, antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat mITT) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol PP). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. Findings Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points SD 7·5, BA 8·4 PHQ-9 points 7·0, mean difference 0·1 PHQ-9 points 95% CI −1·3 to 1·5, p=0·89; PP: CBT 7·9 PHQ-9 points 7·3; BA 7·8 6·5, mean difference 0·0 PHQ-9 points –1·5 to 1·6, p=0·99). Two (1%) non-trial-related deaths (one 1% multidrug toxicity in the BA group and one 1% cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three 2% participants in the BA group (two 1% patients who overdosed and one 1% who self-harmed) and eight (4%) participants in the CBT group (seven 4% who overdosed and one 1% who self-harmed). Interpretation We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. Funding National Institute for Health Research.
Summary Background Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current ...recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. Methods In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. Findings Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67–1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. Interpretation We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. Funding National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.
Summary Background Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children. We therefore investigated the efficacy of ...such an intervention in a larger trial. Methods Children with core autism (aged 2 years to 4 years and 11 months) were randomly assigned in a one-to-one ratio to a parent-mediated communication-focused (Preschool Autism Communication Trial PACT) intervention or treatment as usual at three specialist centres in the UK. Those assigned to PACT were also given treatment as usual. Randomisation was by use of minimisation of probability in the marginal distribution of treatment centre, age (≤42 months or >42 months), and autism severity (Autism Diagnostic Observation Schedule-Generic ADOS-G algorithm score 12–17 or 18–24). Primary outcome was severity of autism symptoms (a total score of social communication algorithm items from ADOS-G, higher score indicating greater severity) at 13 months. Complementary secondary outcomes were measures of parent-child interaction, child language, and adaptive functioning in school. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN58133827. Results 152 children were recruited. 77 were assigned to PACT (London n=26, Manchester n=26, and Newcastle n=25); and 75 to treatment as usual (London n=26, Manchester n=26, and Newcastle n=23). At the 13-month endpoint, the severity of symptoms was reduced by 3·9 points (SD 4·7) on the ADOS-G algorithm in the group assigned to PACT, and 2·9 (3·9) in the group assigned to treatment as usual, representing a between-group effect size of −0·24 (95% CI −0·59 to 0·11), after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities. Treatment effect was positive for parental synchronous response to child (1·22, 0·85 to 1·59), child initiations with parent (0·41, 0·08 to 0·74), and for parent-child shared attention (0·33, −0·02 to 0·68). Effects on directly assessed language and adaptive functioning in school were small. Interpretation On the basis of our findings, we cannot recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms; however, a clear benefit was noted for parent-child dyadic social communication. Funding UK Medical Research Council, and UK Department for Children, Schools and Families.
Generic preference-based measures (EuroQoL-5D (EQ-5D) and SF-6D) are used in the economic evaluation of mental health interventions. However, there are inconsistent findings regarding their ...psychometric properties.
To investigate the psychometric properties of the EQ-5D and SF-6D in different mental health conditions, using seven existing data-sets.
The construct validity and responsiveness of the measures were assessed in comparison with condition-specific indicators.
Evidence for construct validity and responsiveness in common mental health and personality disorders was found (correlations 0.22-0.64; effect sizes 0.37-1.24; standardised response means 0.45-1.31). There was some evidence for validity in schizophrenia (correlations 0.05-0.43), but responsiveness was unclear.
EQ-5D and SF-6D can be used in the economic evaluation of interventions for common mental health problems with some confidence. In schizophrenia, a preference-based measure focused on the impact of mental health should be considered.
The Pathway for Eating disorders and Autism developed from Clinical Experience (PEACE pathway) is a clinical pathway of adapted treatment for individuals with eating disorders and autism in the UK. ...This study aims to investigate multidisciplinary clinicians' views of the strengths and challenges of PEACE pathway adaptations, while identifying areas where further improvement is needed.
Semi-structured interviews were conducted with 16 clinicians who worked on the PEACE pathway. Themes relevant to the benefits, challenges and areas of improvement were identified, and a thematic map was produced.
PEACE Pathway brought clinical benefits such as improved understanding of patients' perspective, improved flexibility and individualisation in clinicians' approach, increased patient engagement, and provision of resources that are helpful to all patients with or without autism. Benefits to the service included increase in autism awareness, clinicians' confidence, and team collaboration. Challenges were also identified, including difficulties in incorporating autism adaptations into existing treatment protocol, implementing PEACE at different levels of care, staff schedule conflicts, and increased pressure to meet patients' needs. Overall, there is a need for systemic improvement in aftercare and community support for autism, more suitable autism screening tool, and more structured guidelines for making adaptations.
PEACE Pathway has brought clinical and service benefits, while also bringing practical challenges rooted in the difficulty in distinguishing between autism and eating disorder in comorbid population. Future areas of improvement are highlighted for PEACE resources as well as in the national support system for autistic individuals.
Background Numerous economic models have assessed the cost-effectiveness of antipsychotic medications in schizophrenia. It is important to understand what key impacts of antipsychotic medications ...were considered in the existing models and limitations of existing models in order to inform the development of future models. Objectives This systematic review aims to identify which clinical benefits, clinical harms, costs and cost savings of antipsychotic medication have been considered by existing models, to assess quality of existing models and to suggest good practice recommendations for future economic models of antipsychotic medications. Methods An electronic search was performed on multiple databases (MEDLINE, EMBASE, PsycInfo, Cochrane database of systematic reviews, The NHS Economic Evaluation Database and Health Technology Assessment database) to identify economic models of schizophrenia published between 2005–2020. Two independent reviewers selected studies for inclusion. Study quality was assessed using the National Institute for Health and Care Excellence (NICE) checklist and the Cooper hierarchy. Key impacts of antipsychotic medications considered by exiting models were descriptively summarised. Results Sixty models were included. Existing models varied greatly in key impacts of antipsychotic medication included in the model, especially in clinical outcomes used for assessing reduction in psychotic symptoms and types of adverse events considered in the model. Quality of existing models was generally low due to failure to capture the health and cost impact of adverse events of antipsychotic medications and input data not obtained from best available source. Good practices for modelling antipsychotic medications are suggested. Discussions This review highlights inconsistency in key impacts considered by different models, and limitations of the existing models. Recommendations on future research are provided.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Psychological treatments for adolescents with unipolar major depressive disorder are associated with diagnostic remission within 28 weeks in 65–70% of patients. We aimed to assess the medium-term ...effects and costs of psychological therapies on maintenance of reduced depression symptoms 12 months after treatment.
We did this multicentre, pragmatic, observer-blind, randomised controlled superiority trial (IMPACT) at 15 National Health Service child and adolescent mental health service (CAMHS) clinics in three regions in England. Adolescent patients (aged 11–17 years) with a diagnosis of DSM IV major depressive disorder were randomly assigned (1:1:1), via a web-based randomisation service, to receive cognitive behavioural therapy (CBT) or short-term psychoanalytical therapy versus a reference brief psychological intervention. Randomisation was stochastically minimised by age, sex, self-reported depression sum score, and region. Patients and clinicians were aware of group allocation, but allocation was concealed from outcome assessors. Patients were followed up and reassessed at weeks 6, 12, 36, 52, and 86 post-randomisation. The primary outcome was self-reported depression symptoms at weeks 36, 52, and 86, as measured with the self-reported Mood and Feelings Questionnaire (MFQ). Because our aim was to compare the two psychological therapies with the brief psychosocial intervention, we first established whether CBT was inferior to short-term psychoanalytical psychotherapy for the same outcome. Primary analysis was by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN83033550.
Between June 29, 2010, and Jan 17, 2013, we randomly assigned 470 patients to receive the brief psychosocial intervention (n=158), CBT (n=155), or short-term psychoanalytical therapy (n=157); 465 patients comprised the intention-to-treat population. 392 (84%) patients had available data for primary analysis by the end of follow-up. Treatment fidelity and differentiation were established between the three interventions. The median number of treatment sessions differed significantly between patients in the brief psychosocial intervention group (n=6 IQR 4–11), CBT group (n=9 5–14), and short-term psychoanalytical therapy group (n=11 5–23; p<0·0001), but there was no difference between groups in the average duration of treatment (27·5 SD 21·5, 24·9 17·7, 27·9 16·8 weeks, respectively; Kruskal–Wallis p=0·238). Self-reported depression symptoms did not differ significantly between patients given CBT and those given short-term psychoanalytical therapy at weeks 36 (treatment effect 0·179, 95% CI −3·731 to 4·088; p=0·929), 52 (0·307, −3·161 to 3·774; p=0·862), or 86 (0·578, −2·948 to 4·104; p=0·748). These two psychological treatments had no superiority effect compared with brief psychosocial intervention at weeks 36 (treatment effect −3·234, 95% CI −6·611 to 0·143; p=0·061), 52 (−2·806, −5·790 to 0·177; p=0·065), or 86 (−1·898, −4·922 to 1·126; p=0·219). Physical adverse events (self-reported breathing problems, sleep disturbances, drowsiness or tiredness, nausea, sweating, and being restless or overactive) did not differ between the groups. Total costs of the trial interventions did not differ significantly between treatment groups.
We found no evidence for the superiority of CBT or short-term psychoanalytical therapy compared with a brief psychosocial intervention in maintenance of reduced depression symptoms 12 months after treatment. Short-term psychoanalytical therapy was as effective as CBT and, together with brief psychosocial intervention, offers additional patient choice for psychological therapy, alongside CBT, for adolescents with moderate to severe depression who are attending routine specialist CAMHS clinics.
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and the Department of Health.
Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to ...evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT.
Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up.
Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received.
TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832.
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