Care As Usual Research Articles

Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial.

The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU). A total of 170 cancer survivors were randomly assigned to one of the three study arms: MCGP-CS (n = 57); SGP (n = 56); CAU (n = 57). The primary outcome measure was the Personal Meaning Profile (PMP; total score). Secondary outcome measures were subscales of the PMP, psychological well-being (Scales of Psychological Well-being; SPWB), post-traumatic growth (Posttraumatic Growth Inventory), Mental Adjustment to Cancer (MAC), optimism (Life Orientation Test-Revised), hopelessness (Beck's Hopelessness Scale), psychological distress (anxiety and depression, Hospital Anxiety and Depression Scale; HADS) and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ-C30). Outcome measures were assessed before randomization, post-intervention, and after 3 and 6 months of follow-up (FU). Linear mixed model analyses (intention-to-treat) showed significant differences between MCGP-CS, SGP and CAU on the total PMP score, and on (sub)scales of the PMP, SPWB, MAC and HADS. Post-hoc analyses showed significantly stronger treatment effects of MCGP-CS compared with CAU on personal meaning (d = 0.81), goal-orientedness (d = 1.07), positive relations (d = 0.59), purpose in life (d = 0.69); fighting spirit (d = 0.61) (post-intervention) and helpless/hopeless (d = -0.87) (3 months FU); and distress (d = -0.6) and depression (d = -0.38) (6 months FU). Significantly stronger effects of MCGP-CS compared with SGP were found on personal growth (d = 0.57) (3 months FU) and environmental mastery (d = 0.66) (6 months FU). MCGP-CS is an effective intervention for cancer survivors to improve personal meaning, psychological well-being and mental adjustment to cancer in the short term, and to reduce psychological distress in the long run.

Survival analysis of the CEAwatch multicentre clustered randomized trial.

The CEAwatch randomized trial showed that follow-up with intensive carcinoembryonic antigen (CEA) monitoring (CEAwatch protocol) was better than care as usual (CAU) for early postoperative detection of colorectal cancer recurrence. The aim of this study was to calculate overall survival (OS) and disease-specific survival (DSS). For all patients with recurrence, OS and DSS were compared between patients detected by the CEAwatch protocol versus CAU, and by the method of detection of recurrence, using Cox regression models. Some 238 patients with recurrence were analysed (7·5 per cent); a total of 108 recurrences were detected by CEA blood test, 64 (55·2 per cent) within the CEAwatch protocol and 44 (41·9 per cent) in the CAU group (P = 0·007). Only 16 recurrences (13·8 per cent) were detected by patient self-report in the CEAwatch group, compared with 33 (31·4 per cent) in the CAU group. There was no significant improvement in either OS or DSS with the CEAwatch protocol compared with CAU: hazard ratio 0·73 (95 per cent 0·46 to 1·17) and 0·78 (0·48 to 1·28) respectively. There were no differences in survival when recurrence was detected by CT versus CEA measurement, but both of these methods yielded better survival outcomes than detection by patient self-report. There was no direct survival benefit in favour of the intensive programme, but the CEAwatch protocol led to a higher proportion of recurrences being detected by CEA-based blood test and reduced the number detected by patient self-report. This is important because detection of recurrence by blood test was associated with significantly better survival than patient self-report, indirectly supporting use of the CEAwatch protocol.

Long-term clinical outcomes and economic evaluation of the ketogenic diet versus care as usual in children and adolescents with intractable epilepsy

ObjectiveTo examine long-term retention rate, clinical outcomes, cost-utility and cost-effectiveness of the Ketogenic Diet (KD) compared with care as usual (CAU) in children and adolescents with intractable epilepsy from a societal perspective. MethodsParticipants were randomized into a KD or CAU group. Seizure frequency, quality adjusted life years (QALYs), side-effects, seizure severity, health care costs, production losses, patient and family costs were assessed at baseline and during 16-months of follow-up. Incremental cost-effectiveness ratios (ICERs) (i.e. cost per QALY and cost per responder) and cost-effectiveness acceptability curves are presented. Results48 children were included in the analyses of this study (26 from KD group). In total, 58% of the KD group completed the follow-up of 16 months; 11 dropped-out for various reasons. At 16 months, 35% of the KD participants had a seizure reduction≥50% from baseline, compared with 18% of the CAU participants. Mean costs per patient in the CAU group were €53,367 (extrapolated) compared to €61,019 per patient in the KD group, resulting in an ICER of €46,564 per responder. Cost per QALY rose well above any acceptable ceiling ratio. At 4-months’ follow-up, the KD group showed significantly more gastro-intestinal problems compared to the CAU group. At 16 months, the KD group reported fewer problems compared to CAU. Furthermore, 46.2% of the KD group reported a decrease in severity of their worst seizure compared to 32% of the CAU group. ConclusionThe KD group resulted in more responders and showed greater improvement on seizure severity. Furthermore, the KD did not lead to worsening of side-effects other than gastro-intestinal problems (only at 4 months’ follow-up). However, as only a minimal difference in QALYs was found between the KD group and the CAU group, the resulting cost per QALY ratios were inconclusive.

P3.05-008 Mindfulness-Based Stress Reduction Added to Care as Usual for Lung Cancer Patients and Their Partners: A Randomized Controlled Trial: Topic: Symptoms, Therapeutic Interventions

Lung cancer patients and their partners report among the highest distress rates of all cancer patients. Possibly because of the poor prognosis and fast deterioration of physical health, limited research has been conducted in lung cancer on how to reduce patients’ and partners’ distress levels. The present study examined the effectiveness of additional Mindfulness-Based Stress Reduction (CAU+MBSR) versus solely care as usual (CAU) to reduce psychological distress in lung cancer patients and partners. We performed a multicenter, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT01494883). Patients with lung cancer and their partners were randomly allocated to CAU+MBSR or CAU. MBSR is an 8-week group-based intervention, including mindfulness practice and psycho-education on stress. CAU included anti-cancer treatment, medical consultations and supportive care. The primary outcome was psychological distress. Secondary outcomes included quality of life, caregiver burden, relationship satisfaction, mindfulness skills, self-compassion, rumination and post-traumatic stress symptoms. Outcomes were assessed at baseline, post-intervention and at 3-month follow-up. Linear mixed modeling was conducted on an intention-to-treat sample. Moderation analyses were performed. 31 patients and 21 partners were randomized to CAU+MBSR and 32 patients and 23 partners to CAU. CAU+MBSR patients reported significantly less psychological distress (p=.010, d=.69) than CAU patients. Baseline distress levels moderated outcome: those with more distress benefitted most from MBSR. Additionally, CAU+MBSR patients showed more improvements in quality of life (p=.044, d=.62), mindfulness skills (p=.005, d=.76), self-compassion (p=.017, d=.75) and rumination (p=.015, d=.70) than CAU patients. In partners, no differences were found between groups. Our findings suggest that psychological distress in lung cancer patients can be effectively treated with MBSR. No effect was found in partners. More research is needed on facilitators and barriers of participation to make effective psychosocial interventions more accessible to lung cancer patients and their partners.

Advantages of person-centered and integrated care service: results of Mixed Method Research on Embrace

Introduction : Health care systems are challenged by the changing demands for care and support of older adults. Integrated care models may provide a solution for these transformations. Embrace is a recently developed population-based, person-centered, and integrated care service for community-living older adults. It was implemented in the Netherlands in 2012. Currently, 2600 older adults from 29 general practitioner (GP) practices are participating. We evaluated the effects of Embrace regarding patient outcomes and experiences, quality of care, and service use and costs using Mixed Methods Research. Theory/Methods: Intervention. Embrace combines the Chronic Care Model with risk profiles based on a population health management model. A multidisciplinary Elderly Care Team – consisting of a GP, an elderly care physician, and two case managers (district nurse and social worker) – provide care and support. The intensity level, focus, and individual or group approach of the care and support depends on an older adults’ risk profile. Design. We used different measurement instruments, e.g. the specifically developed GeriatrICS (a geriatric core set based on the ICF) and the Patient Assessment of Integrated Elderly Care (PAIEC), to assess the effects of Embrace after twelve months using Mixed Methods. A Randomized Clinical Trial and cost-effectiveness study was conducted to assess the effectiveness of Embrace on patient outcomes for older adults, their perceived quality of care, and service use and costs. Qualitative studies were performed to determine the experiences of older adults and professionals with Embrace. One group pre-post studies were conducted to evaluate professionals’ perceived quality of care, effects of Embrace on health-related problems, and goal attainment scores. Furthermore, the long term effects of Embrace will be assessed. Results : (Patient outcomes and experiences) The RCT showed no clear advantages of Embrace regarding the domains health, well-being, and self-management. The qualitative study showed that older adults felt safe and secure and had the confidence to remain living at home. The preliminary findings of the pre-post study indicated that the number and severity of perceived health-related problems decreased. Quality of care. Results of the RCT showed that older adults in the Embrace group reported greater improvement in quality of care compared to care as usual (CAU). In addition, professionals reported a significant increase in the level of integrated care. A qualitative study showed that case managers identified problems early, took preventive actions, and felt more competent to meet their clients’ needs. Service use and costs. Findings of the cost-effectiveness study will be available in May 2016. Discussion : Embrace care and support has several advantages compared to CAU. Quality of care improved, older adults felt safe, secure, and in control, case managers felt that they were able to connect fragmented and discontinuous elderly care, and the number and severity of perceived health-related problems decreased. Embrace yielded greatest improvement in the “Frail” risk profile, a subgroup of older adults “at risk” of poor health outcomes with no immediate need for professional care yet. This specific group is usually not eligible for integrated care services even though these could be increasingly effective for their health outcomes in the long run. Lessons learned: Complex interventions such as Embrace require a multimethod evaluation to obtain a complete overview of the effects. Focusing only on a RCT would lead to limited conclusions. Furthermore, commonly used measurement instruments for health and well-being may not have been sufficiently sensitive to change to detect advantages of Embrace in clinical practice. This may explain why we only found effects using the specifically developed measurement instruments (GeriatrICS and PAEIC). Limitations : A limitation of this study is that we randomized participating older adults within the GP practices. This may have led to some contamination of CAU via the members of the Elderly Care Team. In addition, we had no control groups for the studies on professionals’ perspectives on quality of care and on older adults’ health-related problems. Future research : Future research should focus on the long-term effects of Embrace and on evaluating the process of care provision. Furthermore, the effects of Embrace in other geographical areas and in other cultures with different healthcare systems should be explored. Conclusion : Mixed Methods Research showed that receiving care and support by Embrace for twelve months resulted in several advantages compared to care as usual.

Cost-Utility of Stepped Care Targeting Psychological Distress in Patients With Head and Neck or Lung Cancer.

Purpose A stepped care (SC) program in which an effective yet least resource-intensive treatment is delivered to patients first and followed, when necessary, by more resource-intensive treatments was found to be effective in improving distress levels of patients with head and neck cancer or lung cancer. Information on the value of this program for its cost is now called for. Therefore, this study aimed to assess the cost-utility of the SC program compared with care-as-usual (CAU) in patients with head and neck cancer or lung cancer who have psychological distress. Patients and Methods In total, 156 patients were randomly assigned to SC or CAU. Intervention costs, direct medical costs, direct nonmedical costs, productivity losses, and health-related quality-of-life data during the intervention or control period and 12 months of follow-up were calculated by using Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry, Productivity and Disease Questionnaire, and EuroQol-5 Dimension measures and data from the hospital information system. The SC program's value for the cost was investigated by comparing mean cumulative costs and quality-adjusted life years (QALYs). Results After imputation of missing data, mean cumulative costs were -€3,950 (95% CI, -€8,158 to -€190) lower, and mean number of QALYs was 0.116 (95% CI, 0.005 to 0.227) higher in the intervention group compared with the control group. The intervention group had a probability of 96% that cumulative QALYs were higher and cumulative costs were lower than in the control group. Four additional analyses were conducted to assess the robustness of this finding, and they found that the intervention group had a probability of 84% to 98% that cumulative QALYs were higher and a probability of 91% to 99% that costs were lower than in the control group. Conclusion SC is highly likely to be cost-effective; the number of QALYs was higher and cumulative costs were lower for SC compared with CAU.

Copenhagen infant mental health project: study protocol for a randomized controlled trial comparing circle of security -parenting and care as usual as interventions targeting infant mental health risks.

BackgroundInfant mental health is a significant public health issue as early adversity and exposure to early childhood stress are significant risk factors that may have detrimental long-term developmental consequences for the affected children. Negative outcomes are seen on a range of areas such as physical and mental health, educational and labor market success, social network and establishing of family. Secure attachment is associated with optimal outcomes in all developmental domains in childhood, and both insecure and disorganized attachment are associated with a range of later problems and psychopathologies. In disadvantaged populations insecure and disorganized attachment are common, which points to the need of identifying early risk and effective methods of addressing such problems. This protocol describes an experimental evaluation of an indicated group-based parental educational program, Circle of Security–Parenting (COS-P), currently being conducted in Denmark.Methods/designIn a parallel randomized controlled trial of two intervention groups this study tests the efficacy of COS-P compared to Care as Usual (CAU) in enhancing maternal sensitivity and child attachment in a community sample in the City of Copenhagen, Denmark. During the project a general population of an estimated 17.600 families with an infant aged 2–12 months are screened for two known infant mental health risks, maternal postnatal depression and infant social withdrawal. Eligible families (N = 314), who agree to participate, will be randomly allocated with a ratio of 2:1 into the COS-P intervention arm and into CAU. Data will be obtained at inclusion (baseline) and at follow-up when the child is 12–16 months. The primary outcome is maternal sensitivity. Secondary outcomes include quality of infant attachment, language, cognitive and socioemotional development, family functioning, parental stress, parental mentalizing and maternal mental wellbeing.DiscussionThe potential implications of the experimental evaluation of an indicated brief group-based parenting educational program to enhance parental sensitivity and attachment are discussed.Trial registrationClinicalTrials.govID: NCT02497677. Registered July 15 2015

Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial.

Internet-based cognitive-behavioural treatment (ICBT) for anxiety disorders has shown some promise, but no study has yet examined unguided ICBT in primary care. This randomized controlled trial (RCT) investigated whether a transdiagnostic, unguided ICBT programme for anxiety disorders is effective in primary care settings, after a face-to-face consultation with a physician (MD). We hypothesized that care as usual (CAU) plus unguided ICBT would be superior to CAU in reducing anxiety and related symptoms among patients with social anxiety disorder (SAD), panic disorder with or without agoraphobia (PDA) and/or generalized anxiety disorder (GAD). Adults (n=139) with at least one of these anxiety disorders, as reported by their MD and confirmed by a structured diagnostic interview, were randomized. Unguided ICBT was provided by a novel transdiagnostic ICBT programme ('velibra'). Primary outcomes were generic measures, such as anxiety and depression symptom severity, and diagnostic status at post-treatment (9 weeks). Secondary outcomes included anxiety disorder-specific measures, quality of life, treatment adherence, satisfaction, and general psychiatric symptomatology at follow-up (6 months after randomization). CAU plus unguided ICBT was more effective than CAU at post-treatment, with small to medium between-group effect sizes on primary (Cohen's d=0.41-0.47) and secondary (Cohen's d=0.16-0.61) outcomes. Treatment gains were maintained at follow-up. In the treatment group, 28.2% of those with a SAD diagnosis, 38.3% with a PDA diagnosis, and 44.8% with a GAD diagnosis at pretreatment no longer fulfilled diagnostic criteria at post-treatment. The unguided ICBT intervention examined is effective for anxiety disorders when delivered in primary care.

Positive parenting for healthy living (Triple P) for parents of children with type 1 diabetes: protocol of a randomised controlled trial.

BackgroundType 1 diabetes is a serious, life-long condition which causes major health, social and economic burden for children, their families and the community. Diabetes management involves strict adherence to a complex regimen, and poor management and non-adherence are a persistent problem among children. Parent-child interactions and parenting have been identified as crucial points of intervention to support children’s health and emotional well-being, yet few parenting interventions have been developed or evaluated for parents of young children. This paper describes a randomised controlled trial of a brief, group-based parenting intervention for parents of young children (2-10 years) with type 1 diabetes compared against care as usual (CAU).Methods/designFamilies will be randomised to either Positive Parenting for Healthy Living Triple P or CAU. Positive Parenting for Healthy Living Triple P involves 2 × 2 h group sessions. Outcomes will be assessed via parent and child questionnaire, home observations and blood glucose monitoring at baseline, 1-month and 6-months post-intervention. Primary outcomes will be parent- and child-reported parenting behaviour, parent-reported child behaviour and adjustment, and parent-reported child quality-of-life. Secondary outcomes will include parental self-efficacy with diabetes management, illness-specific and general parenting stress, parent-reported child illness behaviour, family quality-of-life, observed parenting and child behaviour, and child’s illness control.DiscussionThe theoretical background, study hypotheses, methods and planned analyses are discussed.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12613001281785. Registered 20 November, 2013.

Stepped care targeting psychological distress in head and neck cancer and lung cancer patients: a randomized, controlled trial

This study aimed to evaluate the efficacy of stepped care (SC) targeting psychological distress in head and neck cancer (HNC) and lung cancer (LC) patients. Patients with untreated distress [Hospital Anxiety and Depression Scale (HADS; HADS-D > 7, HADS-A > 7, or HADS-total > 14)] were randomized to SC (n = 75) or care-as-usual (CAU) (n = 81). SC consisted of watchful waiting, guided self-help, problem-solving therapy, and psychotherapy and/or psychotropic medication. The primary outcome measure was the HADS; secondary outcome measures were recovery rate, EORTC QLQ-C30, QLQ-HN35/QLQ-LC13, and IN-PATSAT32. Measures were assessed at baseline, after completion of care, and at 3, 6, 9, and 12 months follow-up. Linear mixed models, t-tests, and effect sizes (ES) were used to assess group differences. Patients with untreated distress were randomized to SC (n = 75) or care-as-usual (CAU) (n = 81). The course of psychological distress was better after SC compared with CAU (HADS-total, P = 0.005; HADS-A, P = 0.046; HADS-D, P = 0.007). The SC group scored better post-treatment (HADS-total, ES = 0.56; HADS-A, ES = 0.38; HADS-D, ES = 0.64) and at 9 months follow-up (HADS-total, ES = 0.42 and HADS-A, ES = 0.40). The recovery rate post-treatment was 55% after SC compared with 29% after CAU (P = 0.002), and 46% and 37% at 12 months follow-up (P = 0.35). Within SC, 28% recovered after watchful waiting, 34% after guided self-help, 9% after problem-solving therapy, and 17% after psychotherapy and/or psychotropic medication. The effect of SC was stronger for patients with a depressive or anxiety disorder compared with patients without such a disorder (HADS-total, P = 0.001; HADS-A, P = 0.003; HADS-D, P = 0.041). SC is effective and speeds up recovery among HNC and LC patients with untreated psychological distress. Netherlands Trial Register (NTR1868).

PREMM: preterm early massage by the mother: protocol of a randomised controlled trial of massage therapy in very preterm infants.

BackgroundPreterm infants follow an altered neurodevelopmental trajectory compared to their term born peers as a result of the influence of early birth, and the altered environment. Infant massage in the preterm infant has shown positive effects on weight gain and reduced length of hospital stay. There is however, limited current evidence of improved neurodevelopment or improved attachment, maternal mood or anxiety. The aim of this study is to investigate the effects of infant massage performed by the mother in very preterm (VPT) infants. Effects on the infant will be assessed at the electrophysiological, neuroradiological and clinical levels. Effects on maternal mood, anxiety and mother-infant attachment will also be measured.Methods/DesignA randomised controlled trial to investigate the effect of massage therapy in VPT infants. Sixty VPT infants, born at 28 to 32 weeks and 6 days gestational age, who are stable, off supplemental oxygen therapy and have normal cranial ultrasounds will be recruited and randomised to an intervention (infant massage) group or a control (standard care) group. Ten healthy term born infants will be recruited as a reference comparison group. The intervention group will receive standardised massage therapy administered by the mother from recruitment, until term equivalent age (TEA). The control group will receive care as usual (CAU). Infants and their mothers will be assessed at baseline, TEA, 12 months and 24 months corrected age (CA), with a battery of clinical, neuroimaging and electrophysiological measures, as well as structured questionnaires, psychoanalytic observations and neurodevelopmental assessments.DiscussionOptimising preterm infant neurodevelopment is a key aim of neonatal research, which could substantially improve long-term outcomes and reduce the socio-economic impact of VPT birth. This study has the potential to give insights into the mother-baby relationship and any positive effects of infant massage on neurodevelopment. An early intervention such as massage that is relatively easy to administer and could alter the trajectory of preterm infant brain development, holds potential to improve neurodevelopmental outcomes in this vulnerable population.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12612000335897. Date registered: 22/3/2012.

Cost-effectiveness of preventive case management for parents with a mental illness: a randomized controlled trial from three economic perspectives.

BackgroundThe children of parents with a mental illness (COPMI) are at increased risk for developing costly psychiatric disorders because of multiple risk factors which threaten parenting quality and thereby child development. Preventive basic care management (PBCM) is an intervention aimed at reducing risk factors and addressing the needs of COPMI-families in different domains. The intervention may lead to financial consequences in the healthcare sector and in other sectors, also known as inter-sectoral costs and benefits (ICBs). The objective of this study was to assess the cost-effectiveness of PBCM from three perspectives: a narrow healthcare perspective, a social care perspective (including childcare costs) and a broad societal perspective (including all ICBs).MethodsEffects on parenting quality (as measured by the HOME) and costs during an 18-month period were studied in in a randomized controlled trial. Families received PBCM (n = 49) or care as usual (CAU) (n = 50). For all three perspectives, incremental cost-effectiveness ratios (ICERs) were calculated. Stochastic uncertainty in the data was dealt with using non-parametric bootstraps. Sensitivity analyses included calculating ICERs excluding cost outliers, and making an adjustment for baseline cost differences.ResultsParenting quality improved in the PBCM group and declined in the CAU group, and PBCM was shown to be more costly than CAU. ICERs differ from 461 Euros (healthcare perspective) to 215 Euros (social care perspective) to 175 Euros (societal perspective) per one point improvement on the HOME T-score. The results of the sensitivity analyses, based on complete cases and excluding cost outliers, support the finding that the ICER is lower when adopting a broader perspective. The subgroup analysis and the analysis with baseline adjustments resulted in higher ICERs.ConclusionsThis study is the first economic evaluation of family-focused preventive basic care management for COPMI in psychiatric and family services. The effects of the chosen perspective on determining the cost-effectiveness of PBCM underscore the importance of economic studies of interdepartmental policies. Future studies focusing on the cost-effectiveness of programs like PBCM in other sites and studies with more power are encouraged as this may improve the quality of information used in supporting decision making.Trial registrationNTR2569, date of registration 2010-10-12.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1498-z) contains supplementary material, which is available to authorized users.

The Efficacy and Cost-Effectiveness of Stepped Care Prevention and Treatment for Depressive and/or Anxiety Disorders: A Systematic Review and Meta-Analysis.

Stepped care is an increasingly popular treatment model for common mental health disorders, given the large discrepancy between the demand and supply of healthcare service available. In this review, we aim to compare the efficacy and cost-effectiveness of stepped care prevention and treatment with care-as-usual (CAU) or waiting-list control for depressive and/or anxiety disorders. 5 databases were utilized from its earliest available records up until April 2015. 10 randomized controlled trials were included in this review, of which 6 examined stepped care prevention and 4 examined stepped care treatment, specifically including ones regarding depressive and/or anxiety disorders. Only trials with self-help as a treatment component were included. Results showed stepped care treatment revealed a significantly better performance than CAU in reducing anxiety symptoms, and the treatment response rate of anxiety disorders was significantly higher in stepped care treatment than in CAU. No significant difference was found between stepped care prevention/treatment and CAU in preventing anxiety and/or depressive disorders and improving depressive symptoms. In conclusion, stepped care model appeared to be better than CAU in treating anxiety disorders. The model has the potential to reduce the burden on existing resources in mental health and increase the reach and availability of service.

A user-developed, user run recovery programme for people with severe mental illness: A randomised control trial

We examined, over a two-year period, the impact of a user-developed and user-run recovery programme (Toward Recovery, Empowerment and Experiential Expertise – TREE) on outcomes in individuals with severe mental illness, as add-on to care as usual. A randomised wait-list controlled design of TREE added to care as usual (CAU) (n = 80), versus CAU only (n = 83), was implemented in patients with severe mental illness. Follow-up was at 12 and at 24 months after inclusion. Primary outcome measures were empowerment, mental health confidence and loneliness. Secondary outcomes were quality of life, self-reported symptoms, care needs, service use and community outcomes (likelihood institutional residence and paid employment).TREE was associated with more mental health confidence (effect size for each year in TREE: 0.058, p = 0.043), less care needs (effect size for each year in TREE: –0.088, p = 0.002), less self-reported symptoms (effect size for each year in TREE: –0.054, p = 0.040) and less likelihood of institutional residence (risk ratio with each year in TREE: 0.79, p = 0.027).User-developed and user-run recovery programmes may bring about small but reliable changes in recovery and community outcome after two years. More research is required to examine how such programmes can become more successful within the context of disability-focused mental health services.

Cognitive and behavioral impact of the ketogenic diet in children and adolescents with refractory epilepsy: A randomized controlled trial.

The ketogenic diet (KD) is increasingly used for the treatment of refractory epilepsy in childhood because of the beneficial effect on seizure reduction. The aim of the current study was to objectively assess cognition and aspects of behavior during the first 4months of a randomized controlled study in children and adolescents. Participants from a tertiary epilepsy center were randomized to a KD group (intervention) or a care-as-usual (CAU) group (control). Follow-up assessments on cognition and behavior were performed approximately 4months after initiation of the KD with a combination of parent report questionnaires and individually administered psychological tests for the children. A total of 50 patients were enrolled in this study, 28 patients from the KD group and 22 patients from the CAU group. The KD group showed lower levels of anxious and mood-disturbed behavior and was rated as more productive. Cognitive test results showed an improvement of activation in the KD group. This study showed a positive impact of the KD on behavioral and cognitive functioning in children and adolescents with refractory epilepsy. More specifically, an activated mood and cognitive activation were observed in patients treated with the KD.

A Web-Based Computer-Tailored Alcohol Prevention Program for Adolescents: Cost-Effectiveness and Intersectoral Costs and Benefits

BackgroundPreventing excessive alcohol use among adolescents is important not only to foster individual and public health, but also to reduce alcohol-related costs inside and outside the health care sector. Computer tailoring can be both effective and cost-effective for working with many lifestyle behaviors, yet the available information on the cost-effectiveness of computer tailoring for reducing alcohol use by adolescents is limited as is information on the costs and benefits pertaining to sectors outside the health care sector, also known as intersectoral costs and benefits (ICBs).ObjectiveThe aim was to assess the cost-effectiveness of a Web-based computer-tailored intervention for reducing alcohol use and binge drinking by adolescents from a health care perspective (excluding ICBs) and from a societal perspective (including ICBs).MethodsData used were from the Alcoholic Alert study, a cluster randomized controlled trial with randomization at the level of schools into two conditions. Participants either played a game with tailored feedback on alcohol awareness after the baseline assessment (intervention condition) or received care as usual (CAU), meaning that they had the opportunity to play the game subsequent to the final measurement (waiting list control condition). Data were recorded at baseline (T0=January/February 2014) and after 4 months (T1=May/June 2014) and were used to calculate incremental cost-effectiveness ratios (ICERs), both from a health care perspective and a societal perspective. Stochastic uncertainty in the data was dealt with by using nonparametric bootstraps (5000 simulated replications). Additional sensitivity analyses were conducted based on excluding cost outliers. Subgroup cost-effectiveness analyses were conducted based on several background variables, including gender, age, educational level, religion, and ethnicity.ResultsFrom both the health care perspective and the societal perspective for both outcome measures, the intervention was more costly and more effective in comparison with CAU. ICERs differed for both perspectives, namely €40 and €79 from the health care perspective to €62 and €144 for the societal perspective per incremental reduction of one glass of alcohol per week and one binge drinking occasion per 30 days, respectively. Subgroup analyses showed, from both perspectives and for both outcome measures, that the intervention was cost-effective for older adolescents (aged 17-19 years) and those at a lower educational level and, from a health care perspective, the male and nonreligious adolescent subgroups.ConclusionsComputer-tailored feedback could be a cost-effective way to target alcohol use and binge drinking among adolescents. Including ICBs in the economic evaluation had an impact on the cost-effectiveness results of the analysis. It could be worthwhile to aim the intervention specifically at specific subgroups.Trial RegistrationNederlands Trial Register: NTR4048; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4048 (Archived by Webcite at http://www.webcitation.org/6c7omN8wG)

A randomized controlled trial of the ketogenic diet in refractory childhood epilepsy.

To evaluate the efficacy and tolerability of the ketogenic diet (KD) during the first 4 months of a randomized controlled trial (RCT) in refractory epilepsy patients aged 1-18 years. Children and adolescents with refractory epilepsy, not eligible for epilepsy surgery, were included. Following 1 month at baseline, patients were randomized to either the KD or to care as usual (CAU).Primary outcome is the proportion of patients with at least 50% reduction in seizure frequency at 4 months. Secondary outcomes are mean percentage of baseline seizures, seizure severity, and side effects. Fifty-seven patients were randomized; nine dropped out, leaving 48 for analysis (i.e., 26 KD, 22 CAU). In an intention-to-treat analysis, 13 patients (50%) treated with the KD and four patients (18.2%) of the CAU group were responders.Mean seizure frequency at 4 months compared to baseline, after removal of two outliers in the KD group, was significantly lower (P = 0.024) in the KD group (56%) (95% CI: 36-76) than in the CAU group (99%) (95% CI: 65-133%).Twice as many patients in the KD group had a relevant decrease in seizure severity score (P = 0.070).Patients treated with the KD had a significantly higher score for gastrointestinal symptoms (P = 0.021) without an increase in the total score of side effects. This trial provides class I evidence that the KD is an effective therapy in children and adolescents with refractory epilepsy compared with CAU. Most often reported side effects are gastrointestinal symptoms.The study has been registered with the Netherlands Trial Registry (NTR2498).

An economic evaluation of the ketogenic diet versus care as usual in children and adolescents with intractable epilepsy: An interim analysis.

To gain insight into the cost-effectiveness of the ketogenic (KD) diet compared with care as usual (CAU) in children and adolescents with intractable epilepsy, we conducted an economic evaluation from a societal perspective, alongside a randomized controlled trial. Participants from a tertiary epilepsy center were randomized into KD (intervention) group or CAU (control) group. Seizure frequency, quality adjusted life years (QALYs), health care costs, production losses of parents and patient, and family costs were assessed at baseline and during a 4-month study period and compared between the intervention and control groups. The incremental cost-effectiveness ratios (ICERs) (i.e., cost per QALY and cost per responder), and cost-effectiveness acceptability curves (CEACs) were calculated and presented. In total, 48 children were included in the analyses of this study (26 KD group). At 4 months, 50% of the participants in the KD group had a seizure reduction ≥50% from baseline, compared with 18.2 of the participants in the CAU group. The mean costs per patient in the CAU group were €15,245 compared to €20,986 per patient in the KD group, resulting in an ICER of €18,044 per responder. We failed, however, to measure any benefits in terms of QALYs and therefore, the cost per QALY rise high above any acceptable ceiling ratio. It might be that the quality of life instruments used in this study were not sufficiently sensitive to detect changes, or it might be that being a clinical responder is not sufficient to improve a patient's quality of life. Univariate and multivariate sensitivity analyses and nonparametric bootstrapping were performed and demonstrated the robustness of our results. The results show that the KD reduces seizure frequency. The study did not find any improvements in quality of life and, therefore, unfavorable cost per QALY ratio's resulted.

The outcome of institutional youth care compared to non-institutional youth care for children of primary school age and early adolescence: A multi-level meta-analysis

ObjectiveThe outcome of institutional youth care for children is heavily debated. This multilevel meta-analysis aims to address the outcome of institutional youth care compared to non-institutional youth care for children of primary school age and early adolescence in economically developed countries. A gain of knowledge in this area may help the decision for referral of children to institutional youth care or other types of care (e.g., foster care or community-based care), and improve outcomes for children in youth care. MethodsOf 19 controlled studies (15.526 participants), 63 effect sizes of behaviour problems (externalizing, internalizing, and total), skills (social and cognitive) and delinquency were computed based on comparisons between institutional Evidence-Based Treatment (EBT), institutional Care As Usual (CAU), non-institutional EBT, and non-institutional CAU. ResultsInstitutional CAU showed a small-to-medium negative significant effect compared to non-institutional CAU (d=−0.342). Furthermore, children in institutional care showed slightly more delinquent behaviour compared to children in non-institutional care (d=−0.329). Significant moderating effects were also found for study design, year of publication and sex of the child. ConclusionsChildren receiving non-institutional CAU (mostly foster care) had slightly better outcomes than children in institutional CAU (regular group care). No differences were found between institutional and non-institutional care when institutional treatment was evidence-based. More research is needed on the conditions that make established treatment methods work in institutional care for (young) children.

Cost effectiveness and budgetary impact of the Boston University approach to Psychiatric Rehabilitation for societal participation in people with severe mental illness: a randomised controlled trial protocol.

BackgroundPeople with Severe Mental Illness (SMI) frequently experience problems with regard to societal participation (i.e. work, education and daily activities outside the home), and require professional support in this area. The Boston University approach to Psychiatric Rehabilitation (BPR) is a comprehensive methodology that can offer this type of support. To date, several Randomised Controlled Trials (RCT’s) investigating the effectiveness of BPR have yielded positive outcomes with regard to societal participation. However, information about the cost-effectiveness and budgetary impact of the methodology, which may be important for broader dissemination of the approach, is lacking. BPR may be more cost effective than Care As Usual (CAU) because an increase in participation and independence may reduce the costs to society. Therefore, the aim of this study is to investigate, from a societal perspective, the cost-effectiveness of BPR for people with SMI who wish to increase their societal participation. In addition, the budget impact of implementing BPR in the Dutch healthcare setting will be assessed by means of a budget impact analysis (BIA) after completion of the trial.MethodsIn a multisite RCT, 225 adults (18–64 years of age) with SMI will be randomly allocated to the experimental (BPR) or the control condition (CAU). Additionally, a pilot study will be conducted with a group of 25 patients with severe and enduring eating disorders. All participants will be offered support aimed at personal rehabilitation goals, and will be monitored over a period of a year. Outcomes will be measured at baseline, and at 6 and 12 months after enrolment. Based on trial results, further analyses will be performed to assess cost-effectiveness and the budgetary impact of implementation scenarios.DiscussionThe trial results will provide insight into the cost-effectiveness of BPR in supporting people with SMI who would like to increase their level of societal participation. These results can be used to make decisions about further implementation of the method. Also, assessing budgetary impact will facilitate policymaking. The large sample size, geographic coverage and heterogeneity of the study group will ensure reliable generalisation of the study results.Trial registrationCurrent Controlled Trials: ISRCTN88987322. Registered 13 May 2014.