scholarly journals Multisystemic therapy compared with management as usual for adolescents at risk of offending: the START II RCT

2020 ◽  
Vol 8 (23) ◽  
pp. 1-114
Author(s):  
Peter Fonagy ◽  
Stephen Butler ◽  
David Cottrell ◽  
Stephen Scott ◽  
Stephen Pilling ◽  
...  

Background The Systemic Therapy for At Risk Teens (START) trial is a randomised controlled trial of multisystemic therapy (MST) compared with management as usual (MAU). The present study reports on long-term follow-up of the trial (to 60 months). Objectives The primary objective was to compare MST and MAU for the proportion of young people in each group with criminal convictions up to 60 months post baseline. Secondary outcomes included group comparisons of psychological and behavioural factors. An economic analysis was carried out to determine the cost-effectiveness of MST compared with MAU. Two qualitative studies were conducted to better understand the subjective experiences of the participants. Design Primary outcomes (collected up to 60 months) were collected using a centralised police database. Secondary outcomes were evaluated using self-report questionnaires completed by both young people and parents or carers at the 24-, 36- and 48-month follow-ups. Research assistants were blind to treatment allocation. Setting Participants were recruited from participating MST sites in nine areas of England. Secondary outcomes were typically collected within the family home. Participants A total of 684 families were recruited into the START trial and allocated randomly to a treatment group. Of these, 487 remained in the second phase of the trial. Young people were aged, on average, 13.8 years at baseline, with 63% male and 37% female. Interventions MST is a manualised programme for young people exhibiting antisocial behaviour and their families that uses principles from cognitive–behavioural and family therapy to provide an individualised approach. MAU content was not prespecified, but consisted of the standard care offered to young people who met eligibility for the trial. Main outcome measures Young people’s offending was evaluated using the Police National Computer. Secondary measures included validated self-report measures completed by both the young person and their parent or carer. The economic evaluation took a broad perspective and outcomes were assessed in terms of quality-adjusted life-years and offending. Results No significant differences were found in the proportion of offending between the groups (hazard ratio 1.03, 95% confidence interval 0.84 to 1.26; p = 0.78). No differences were found between the groups on secondary outcome measures, with a few exceptions that did not hold up consistently across the follow-up period. The economic analysis did not find evidence to support the cost-effectiveness of MST compared with MAU. Outcomes from the qualitative studies suggest that families mostly felt positive about MST, and that MST was associated with greater maturity in young men. Limitations Some intended evaluations were not possible to deliver. Selective attrition may have influenced the nature of the sample size. It is also unclear how representative the MAU services were of reality. Future research Recommendations are made for the evaluation of MST in populations with more severe behavioural problems, as well as for identifying and testing new moderators. Conclusions The results of the second phase of the START trial do not support the long-term superiority of MST to MAU, but elements of the intervention may be adapted successfully. Trial registration Current Controlled Trials ISRCTN77132214 and London South-East REC registration number 09/H1102/55. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 23. See the NIHR Journals Library website for further project information.

2017 ◽  
Vol 21 (64) ◽  
pp. 1-244 ◽  
Author(s):  
Ana Duarte ◽  
Teumzghi Mebrahtu ◽  
Pedro Saramago Goncalves ◽  
Melissa Harden ◽  
Ruth Murphy ◽  
...  

Background Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA®, AbbVie, Maidenhead, UK), etanercept (Enbrel®, Pfizer, New York, NY, USA) and ustekinumab (STELARA®, Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. Objective To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people. Data sources Searches of the literature and regulatory sources, contact with European psoriasis registries, company submissions and clinical study reports from manufacturers, and previous National Institute for Health and Care Excellence (NICE) technology appraisal documentation. Review methods Included studies were summarised and subjected to detailed critical appraisal. A network meta-analysis incorporating adult data was developed to connect the effectiveness data in children and young people and populate a de novo decision-analytic model. The model estimated the cost-effectiveness of adalimumab, etanercept and ustekinumab compared with each other and with either methotrexate or best supportive care (BSC), depending on the position of the intervention in the management pathway. Results Of the 2386 non-duplicate records identified, nine studies (one randomised controlled trial for each drug plus six observational studies) were included in the review of clinical effectiveness and safety. Etanercept and ustekinumab resulted in significantly greater improvements in psoriasis symptoms than placebo at 12 weeks’ follow-up. The magnitude and persistence of the effects beyond 12 weeks is less certain. Adalimumab resulted in significantly greater improvements in psoriasis symptoms than methotrexate for some but not all measures at 16 weeks. Quality-of-life benefits were inconsistent across different measures. There was limited evidence of excess short-term adverse events; however, the possibility of rare events cannot be excluded. The majority of the incremental cost-effectiveness ratios for the use of biologics in children and young people exceeded NICE’s usual threshold for cost-effectiveness and were reduced significantly only when combined assumptions that align with those made in the management of psoriasis in adults were adopted. Limitations The clinical evidence base for short- and long-term outcomes was limited in terms of total participant numbers, length of follow-up and the absence of young children. Conclusions The paucity of clinical and economic evidence to inform the cost-effectiveness of biological treatments in children and young people imposed a number of strong assumptions and uncertainties. Health-related quality-of-life (HRQoL) gains associated with treatment and the number of hospitalisations in children and young people are areas of considerable uncertainty. The findings suggest that biological treatments may not be cost-effective for the management of psoriasis in children and young people at a willingness-to-pay threshold of £30,000 per quality-adjusted life-year, unless a number of strong assumptions about HRQoL and the costs of BSC are combined. Registry data on biological treatments would help determine safety, patterns of treatment switching, impact on comorbidities and long-term withdrawal rates. Further research is also needed into the resource use and costs associated with BSC. Adequately powered randomised controlled trials (including comparisons against placebo) could substantially reduce the uncertainty surrounding the effectiveness of biological treatments in biologic-experienced populations of children and young people, particularly in younger children. Such trials should establish the impact of biological therapies on HRQoL in this population, ideally by collecting direct estimates of EuroQol-5 Dimensions for Youth (EQ-5D-Y) utilities. Study registration This study is registered as PROSPERO CRD42016039494. Funding The National Institute for Health Research Health Technology Assessment programme.


ESC CardioMed ◽  
2018 ◽  
pp. 1395-1399
Author(s):  
Ruben L. J. Osnabrugge ◽  
A. Pieter Kappetein

Approximately 2% of the total healthcare expenditure in the European Union is spent on coronary artery disease and these expenditures are expected to increase. In order to make rational decisions on resource allocation, clinical and economic outcomes of treatment strategies need to be analysed together. Cost-effectiveness studies provide a framework for making such decisions. The early economic studies comparing balloon angioplasty with coronary artery bypass grafting (CABG) show that the early cost benefit of angioplasty is lost at long-term follow-up. CABG provides a clinically and economically attractive treatment option in patients with severe coronary artery disease. Later studies with bare-metal or drug eluting stents showed that the higher invasiveness of CABG leads to a longer hospital stay and higher upfront costs. However, at longer follow-up the cost difference is small and clinical outcomes with CABG are better than with percutaneous coronary intervention (PCI). This makes CABG superior to PCI at long-term follow-up, both clinically and economically in patients with extensive coronary disease. Nevertheless, in patients with less complex coronary artery disease, PCI with drug-eluting stents may be preferred on both clinical and economic grounds. Although reduction in stent price does not have a big impact, several other developments may impact future economic comparisons between PCI and CABG. Newer-generation stents will enhance the clinical and economic profile of PCI. Moreover, better clinical decision-making tools and fractional flow reserve will impact the cost-effectiveness equation.


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 19-19 ◽  
Author(s):  
Christopher Parker ◽  
Gemma Kay ◽  
Esprit Ma ◽  
Beth Woods ◽  
James Eaton ◽  
...  

19 Background: In 2015, the Scottish Medicines Consortium (SMC) made a positive recommandation for brentuximab vedotin (BV) in patients with relapsed or refractory (R/R) Hodgkin lymphoma (HL) who have received autologous stem cell transplantation (ASCT) based on 3-year follow-up data from the pivotal phase 2 single-arm trial (SG035-0003; NCT00848926). At 3-years, the incremental cost-effectiveness ratio (ICER) for brentuximab vedotin compared with chemotherapy +/- radiotherapy (C/R) was £43,731 per quality-adjusted life year (QALY). This study re-evaluated the cost-effectiveness analysis with 5-year follow-up data from the pivotal trial. Methods: A partitioned survival model was developed using a Scottish health system perspective over a lifetime time-horizon. Three health states were evaluated: progression-free survival (PFS), post-progression survival, and death. The relevant comparators were C/R, or C/R with intent to allogeneic stem cell transplantation. Clinical outcomes (PFS and overall survival [OS]) for BV were estimated based on data from the pivotal trial in 102 patients. A naïve comparison with the specified comparators was conducted using published survival data. ICERs were calculated with measures of the clinical outcomes, direct costs and QALYs. Deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness of the model. Results: The 5-year follow-up data reduced the base case ICER for BV from £43,731 to £38,769 per QALY versus C/R and increased the probability of cost-effectiveness. The variation in ICER for BV generated by the deterministic sensitivity analyses was also reduced resulting from reduced uncertainty in the estimation of long term clinical outcomes. Conclusions: This update has strengthened the cost-effectiveness evidence for BV in patients with R/R HL post-ASCT. The 5-year follow-up has reduced the uncertainty in the long term outcomes and reduced the ICER, which is low in comparison to other treatments for orphan diseases approved by UK agencies. BV may therefore represent a cost-effective treatment option for this patient group.


2016 ◽  
Vol 190 ◽  
pp. 254-263 ◽  
Author(s):  
Timo Maljanen ◽  
Paul Knekt ◽  
Olavi Lindfors ◽  
Esa Virtala ◽  
Päivi Tillman ◽  
...  

2012 ◽  
Vol 43 (2) ◽  
pp. 363-374 ◽  
Author(s):  
E. Hedman ◽  
E. Andersson ◽  
N. Lindefors ◽  
G. Andersson ◽  
C. Rück ◽  
...  

BackgroundSevere health anxiety is a common condition associated with functional disability, making it a costly disorder from a societal perspective. Internet-based cognitive behaviour therapy (ICBT) is a promising treatment but no previous study has assessed the cost-effectiveness or long-term outcome of ICBT for severe health anxiety. The aim of this study was to investigate the cost-effectiveness and 1-year treatment effects of ICBT for severe health anxiety.MethodCost-effectiveness and 1-year follow-up data were obtained from a randomized controlled trial (RCT) comparing ICBT (n = 40) to an attention control condition (CC,n = 41). The primary outcome measure was the Health Anxiety Inventory (HAI). A societal perspective was taken and incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling.ResultsThe main ICER was −£1244, indicating the societal economic gain for each additional case of remission when administering ICBT. Baseline to 1-year follow-up effect sizes on the primary outcome measure were large (d = 1.71–1.95).ConclusionsICBT is a cost-effective treatment for severe health anxiety that can produce substantial and enduring effects.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A177-A177
Author(s):  
Jaejin An ◽  
Dennis Hwang ◽  
Jiaxiao Shi ◽  
Amy Sawyer ◽  
Aiyu Chen ◽  
...  

Abstract Introduction Trial-based tele-obstructive sleep apnea (OSA) cost-effectiveness analyses have often been inconclusive due to small sample sizes and short follow-up. In this study, we report the cost-effectiveness of Tele-OSA using a larger sample from a 3-month trial that was augmented with 2.75 additional years of epidemiologic follow-up. Methods The Tele-OSA study was a 3-month randomized trial conducted in Kaiser Permanente Southern California that demonstrated improved adherence in patients receiving automated feedback messaging regarding their positive airway pressure (PAP) use when compared to usual care. At the end of the 3 months, participants in the intervention group pseudo-randomly either stopped or continued receiving messaging. This analysis included those participants who had moderate-severe OSA (Apnea Hypopnea Index >=15) and compared the cost-effectiveness of 3 groups: 1) no messaging, 2) messaging for 3 months only, and 3) messaging for 3 years. Costs were derived by multiplying medical service use from electronic medical records times costs from Federal fee schedules. Effects were average nightly hours of PAP use. We report the incremental cost per incremental hour of PAP use as well as the fraction acceptable. Results We included 256 patients with moderate-severe OSA (Group 1, n=132; Group 2, n=79; Group 3, n=45). Group 2, which received the intervention for 3 months only, had the highest costs and fewest hours of use and was dominated by the other two groups. Average 1-year costs for groups 1 and 3 were $6035 (SE, $477) and $6154 (SE, $575), respectively; average nightly hours of PAP use were 3.07 (SE, 0.23) and 4.09 (SE, 0.42). Compared to no messaging, messaging for 3 years had an incremental cost ($119, p=0.86) per incremental hour of use (1.02, p=0.03) of $117. For a willingness-to-pay (WTP) of $500 per year ($1.37/night), 3-year messaging has a 70% chance of being acceptable. Conclusion Long-term Tele-OSA messaging was more effective than no messaging for PAP use outcomes but also highly likely cost-effective with an acceptable willingness-to-pay threshold. Epidemiologic evidence suggests that this greater use will yield both clinical and additional economic benefits. Support (if any) Tele-OSA study was supported by the AASM Foundation SRA Grant #: 104-SR-13


2021 ◽  
pp. 105566562110698
Author(s):  
Kristaninta Bangun ◽  
Jessica Halim ◽  
Vika Tania

Chromosome 17 duplication is correlated with an increased risk of developmental delay, birth defects, and intellectual disability. Here, we reported a female patient with trisomy 17 on the whole short arm with bilateral complete cleft lip and palate (BCLP). This study will review the surgical strategies to reconstruct the protruding premaxillary segment, cleft lip, and palate in trisomy 17p patient. The patient had heterozygous pathogenic duplication of chromosomal region chr17:526-18777088 on almost the entire short arm of chromosome 17. Beside the commonly found features of trisomy 17p, the patient also presented with BCLP with a prominent premaxillary portion. Premaxillary setback surgery was first performed concomitantly with cheiloplasty. The ostectomy was performed posterior to the vomero-premaxillary suture (VPS). The premaxilla was firmly adhered to the lateral segment and the viability of philtral flap was not compromised. Two-flap palatoplasty with modified intravelar veloplasty (IVV) was performed 4 months after. Successful positioning of the premaxilla segment, satisfactory lip aesthetics, and vital palatal flap was obtained from premaxillary setback, primary cheiloplasty, and subsequent palatoplasty in our trisomy 17p patient presenting with BLCP. Postoperative premaxillary stability and patency of the philtral and palatal flap were achieved. Longer follow-up is needed to evaluate the long-term effects of our surgical techniques on inhibition of midfacial growth. However, the benefits that the patient received from the surgery in improving feeding capacity and facial appearance early in life outweigh the cost of possible maxillary retrusion.


1978 ◽  
Vol 23 (1_suppl) ◽  
pp. 1-21 ◽  
Author(s):  
Philip Barker

It is impossible to make any sort of comparative evaluation of the various treatment methods which have been recommended and tried for severe, chronic emotional and behavioural disorders in children and young people. Although many programs exist, and many more have existed and been reported, the case material has seldom been clearly defined, outcome studies have been limited and longer-term follow-up almost nil. To take simply the few programs which have been discussed in this paper, it is not known whether the young people treated in the California Youth Project, Aycliffe School, the Cotswold Community and the Alberta Parent Counsellors program are at all similar. All programs claim to be treating seriously disturbed children, but more detailed descriptions are needed. Achievement Place claims it deals with “pre-delinquent” youths, while clearly St. Charles Youth Treatment Centre, Aycliffe School and the California Youth Project treat serious established delinquents. So it may indeed be true, as Hoghughi (21) has suggested, that methods that work in certain situations are not readily transferred to others. Balbernie (8) seems to be on the right lines when he calls for precise diagnosis with an accurate definition of what the problem is and of who is supposed to be doing what about it, and with what aims. Similarly precise requirements seemed to be the policy of Hoghughi at Aycliffe School, when this was visited. Despite the problems of evaluating the different therapeutic approaches, certain points do seem clear from this review and from visits to centres. 1. In many cases treatment of the seriously disturbed, previously intractable, child is a very long-term proposition. A commitment to work with the boy, girl or family for several years, is often necessary. 2. Improvement achieved in residential settings, and while active treatment is in progress, is not always maintained subsequently. There is need for much more investigation of what determines whether improvement is maintained, but many programs provided little data about the aftercare given and the longer-term follow-up of the children treated. 3. Intensive treatment, whether residential or not, only makes sense in the context of a long-continuing program of management. Yet many programs, even the best ones, seem to work in relative isolation. 4. Sequential treatment seems to have much to recommend it, and is used, though in a somewhat different way, by all the four British programs that were visited. 5. Some severely disturbed children can be treated in alternative family settings, but which ones, and with what long-term results, is quite vague. These programs do however have several advantages: they keep children in the community, if not in their own homes; they avoid the dangers of institutionalization and the contaminant effects of living with a delinquent peer group; and they approximate more closely the sort of situation (that is, normal family life) which treatment should be helping children to adapt. They are also much less expensive than residential treatment. 6. There is a role for secure units. All who are familiar with the clinical group we are discussing are aware of the existence of a sub-group of very aggressive and violent children who must first be contained. Some of these children can only be constructively treated in a highly secure and very well-staffed unit, but in such a setting it seems that there is a prospect of providing them with some real help. The British “Youth Treatment Centre” concept does seem a useful one. Many points are unclear. These include the following: 1. Does family therapy have a significant part to play in these cases? There is suggestive evidence that it may in some, but many of these children have no families, or at least none with whom they are in contact, and often have been in institutions for much of their lives. 2. What future is there in “intermediate treatment” and community work? Is it in any way realistic to expect to help severely disturbed children by work in the community of which they are part? 3. Can a community approach like that of the California Youth Project make a real contribution to the problem? It seems that in many cases it is better than traditional institutional treatment, but that itself has great limitations. 4. Which of the many residential programs that have been tried is best for which type of problem? 5. How can residential programs be integrated with services in the child's own community to best advantage? 6. What should be the longer term aims of treatment? The various reports of different programs rarely consider this. In conclusion, two points stand out. The first is the need for properly planned and executed research into the treatment of these disorders. It is amazing that so much has been spent on treatment and so little on its evaluation. Perhaps residential treatment is often seen more as a way of getting difficult children out of their communities. The second conclusion is that surely more effort should be made to prevent these disorders. Relatively few of the children under consideration have been brought up in stable, loving homes by their two natural parents. The apparently progressive deterioration of family life, the abandonment of children to day care, the abrogation by many parents of real responsibility for their children and the loss of moral values and religious beliefs are alarming features of contemporary life. Bronfenbrenner (12) has recently commented on how “the American family is falling apart”, and expressed alarm about the current tendency of people to do their “own thing”, to the exclusion of the interests of others. While most children seem to be able to grow up healthily even in contemporary society, the number who become severely disturbed seems likely to increase as these changes in society occur. At the very least we should give a high priority to giving the very best alternative care to children deprived of normal family life.


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