1,513 research outputs found
Systematic review and analysis of evidences on clinical efficacy and cost-effectiveness of biological drugs for the treatment of Ankylosing Spondylitis
No full textTechnology: Infliximab and comparator biological such as adalimumab, etanercept, golimumab.
Conditions: Ankylosing spondylitis (AS)
Issue: Infliximab is registered to be used in patients with AS. The aim of the Report is to evaluate the clinical efficacy and safety of infliximab and comparator biologicals for the treatment of adult AS.
Methods: Systematic literature review and analysis as well as meta-analysis (direct and indirect comparison) of published randomised controlled clinical trials (RCT) were performed, all relevant health economics literature were identified ad analysed.
Results: Clinical efficacy of biological therapies is based on good clinical evidences regarding to all clinical efficacy endpoints (ASAS20, ASAS40, ASAS 5/6, and BASDAI 50% response). Altogether, 22 trials are included in our meta-analysis, 12 infliximab, 3 adalimumab studies, 6 etanercept and 1 golimumab. Efficacy of biological treatments for the treatment of AS has been established by clinical scientific evidences, significant improvement at all outcomes considered was confirmed. According to the results of indirect comparison, there were no significant difference between biological treatments and placebo in terms of safety and tolerability endpoints. We found no significant difference between the clinical efficacy and safety of infliximab, adalimumab, etanercept and golimumab therapies. Cost-utility analysis of adalimumab and/or infliximab, etanercept and golimumab treatment for AS were performed in the UK, Canada, The Netherlands, Germany, Spain and France. There are no cost-utility studies from Eastern Central Europe.
Implications for decision making: Efficacy of infliximab and comparator biologicals for the treatment of Ankylosing Spondylitis (AS) was proved by clinical evidence, significant improvement at all outcomes considered was confirmed. We found no significant differences in efficacy and safety of different biological treatments. Health economics results suggest that biological therapies are cost-effective alternatives for the treatment of AS in group of developed high income countries. There is a lack of health economics results in Central-Eastern European countries however these data are more and more required by governments and funders as part of the company economic dossiers
Lossless Color Image Compression using Double Level RCT in BBWCA
No full textAbstractA new lossless image compression scheme for natural color images which is based on double level Reversible Color Transform(RCT) and Bi-level Burrows Wheeler Compression Algorithm(BBWCA) is proposed. The first level RCT from RGB to HSV provide higher reduction in number of unique hue components, thus gives higher compression in case of natural images. The first level RCT followed by the second level RCT from HSV to YUV helps to yield small number of unique Y component values. DC level shifting and twos complement operation will be applied as preprocessing steps to second level RCT. The result of double level RCT is used as the input to BBWCA, in which row-wise BWT followed by column-wise BWT is applied. The compressed image data is formed by using move-to-front(MTF), Run-length-encoding and Entropy coding. The proposed method using double level RCT with BBWCA results in high compression by taking advantage of reduction in hue components of natural images. Among the different color space compared, the proposed method achieves better compression and is well suited for small and large size natural images. Proposed method make use of a double level RCT on the existing BBWCA algorithm and resulted in improving the compression ratio by 46 percentage
Design and Performance Enhancement of a Gasoline Engine Turbocharger Compressor by Adopting RCT and Hybrid RCT
No full textThe diesel engine used the turbocharger technology for a long period. To solve the compressor associated with surge unstable phenomena, the medium and large size turbocharger compressor used the RCT(recirculation casing treatment) also called ported shroud technology in a diesel engine. The RCT can decrease the vortex at the impeller part when the compressor is operated in the low mass flow rate working fluid. Due to the casting limitation, the small size compressor which the pressure ratio range from 1.2 to 2.5 is not easy to adopt the RCT technology. The 3D printer technology has been developing very quickly nowadays. It can also be used for the future compressor production. Recently, the turbocharger has been installed to the gasoline engine to increase the engine power and decrease the emission pollution. Most gasoline engine displacement is from 1.3L to 2.0L. Hence, it is essential to investigate the flow and performance of the small-sized gasoline engine turbocharger RCT compressor by using the CFD technology. Comparing the CFD results between the Non-RCT and RCT compressor model, the RCT compressor can increase the efficiency at the low mass flow rate, which improves the unstable flow performance. However, at the medium mass flow rate range, especially the mass flow rate of the gasoline engine at the highest power output point, the RCT compressor has the lower efficiency than the non-RCT compressor. A new Hybrid RCT has been designing by the author which has a small channel connecting the compressor volute downstream part and RCT inlet duct to improve the flow movement by overcoming the adverse pressure gradient. The CFD results showed that the Hybrid RCT compressor had a similar performance with the RCT compressor, but it could increase the efficiency than the RCT compressor at the medium mass flow range and showed higher efficiency in a certain region of compressor than the non-RCT compressor.Docto
Interventions for preventing oral mucositis for patients with cancer receiving treatment
No full textBackground Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers). Objectives To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment. Search strategy Electronic searches of Cochrane Oral Health Group and PaPaS Trials Registers (to 1 June 2010), CENTRAL (The Cochrane Library 2010, Issue 2), MEDLINE via OVID (1950 to 1 June 2010), EMBASE via OVID (1980 to 1 June 2010), CINAHL via EBSCO (1980 to 1 June 2010), CANCERLIT via PubMed (1950 to 1 June 2010), OpenSIGLE (1980 to 2005) and LILACS via the Virtual Health Library (1980 to 1 June 2010) were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. Selection criteria Randomised controlled trials of interventions to prevent oral mucositis in patients receiving treatment for cancer. Data collection and analysis Information regarding methods, participants, interventions, outcome measures, results and risk of bias were independently extracted, in duplicate, by two review authors. Authors were contacted for further details where these were unclear. The Cochrane Collaboration statistical guidelines were followed and risk ratios calculated using random-effects models. Main results A total of 131 studies with 10,514 randomised participants are now included. Nine interventions, where there was more than one trial in the meta-analysis, showed some statistically significant evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis, compared to either a placebo or no treatment. These nine interventions were: allopurinol, aloe vera, amifostine, cryotherapy, glutamine (intravenous), honey, keratinocyte growth factor, laser, and polymixin/tobramycin/amphotericin (PTA) antibiotic pastille/paste. Authors' conclusions Nine interventions were found to have some benefit with regard to preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for further well designed, and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent. This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2010, Issue 12. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review.</p
Pre-notification systematic review follow up nested RCT
No full textThis is an RCT of weather pre-notification increases responses to questionnaires nested in the author follow up of a systematic review investigating the same questio
Pre-notification systematic review follow up nested RCT
No full textThis is an RCT of weather pre-notification increases responses to questionnaires nested in the author follow up of a systematic review investigating the same questio
How big is the elephant in the room? Estimated and actual IT costs in an online behaviour change trial
No full textThe practical and methodological challenges inherent in online behaviour change studies are both novel and complex. We relate our experiences of estimating and managing information technology (IT) research and intervention costs in an ongoing internet trial in the hope that others will find this information useful
What is the impact of contraceptive methods and mixes of contraceptive methods on contraceptive prevalence, unmet need for family planning, and unwanted and unintended pregnancies?
No full textBackground - In many low-and middle-income countries, there is high maternal, infant and child mortality due in part to low contraceptive use and high unmet need for family planning. The aim of this overview of systematic reviews is to synthesise the findings of systematic reviews conducted in this area to assess the impact of various contraceptive methods and mixes of contraceptive methods on contraceptive prevalence, unwanted and unintended pregnancies, and unmet need (a desire to limit the number of children but not currently using any contraception) for family planning in developing countries/regions.Methods - Eight databases (Bioline international, The Cochrane Library, Latin American and Caribbean Health Sciences Literature - LILACS, Popline, PubMed, Turning Research Into Practice, World Health Organisation Reproductive Health Library and Zetoc) were searched from 28 October 2010 to 08 December 2010. Cochrane and non-Cochrane systematic reviews were included. Eligible reviews included studies whose participants were sexually active women or men from countries classified as ‘developing’, ‘low-income’ or ‘middle-income’. Systematic reviews of any intervention (or combination of interventions) designed to increase contraceptive prevalence, reduce fertility or both were eligible. Data were extracted and synthesised narratively. A Measurement Tool to Assess Systematic Reviews, AMSTAR, was used to evaluate the quality of the included systematic reviews, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to evaluate the quality of the body of evidence for each comparison. To aid the interpretation of the findings for a variety of settings, relevant contextual information was presented where possible.Results - There were 22 systematic reviews included in this overview of reviews. The overview examined a range of contraceptive methods, including modern (terminal and spacing) and traditional methods (such as withdrawal and periodic abstinence which do not require contraceptive substances or devices and also do not require clinical procedures). However, the systematic reviews included did not address all the objectives of the overview.The results of the review are summarised below according to the objectives.Objective 1: To assess the impact of various contraceptive methods and mixes ofcontraceptive methods on contraceptive prevalence in developing countries/regions. There was no systematic review that met this objective.Objective 2: To assess the impact of various contraceptive methods and mixes ofcontraceptive methods on unwanted and unintended pregnancies in developingcountries/regions.The body of evidence for the relative efficacy or effectiveness of a variety ofcontraceptive methods to prevent pregnancy in developing countries was generally rated as of low or moderate quality. There was, however, a number of comparisons (between different derivatives of the same contraceptive methods) for which the evidence was rated as of high or moderate quality. Evidence from systematic reviews is lacking on the acceptability of contraceptive methods and their impact on prevalence and on unmet needs for family planning. The evidence for the relative effectiveness of a variety of contraceptive methods to prevent pregnancy in developing countries is generally of low quality. There is some high-quality evidence comparing different derivatives of the same contraceptive methods, although this is more often evidence of efficacy than evidence of effectiveness.Objective 3: To assess the impact of various contraceptive methods and mixes ofcontraceptive methods on unmet need for family planning in developing countries/regions.There was no systematic review that met this objective
Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity : study protocol for a randomized controlled trial
No full textBackground:
Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base.
Methods/design:
This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).
Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.
A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children’s BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style will also be assessed.
Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.
Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made.
Discussion:
This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation.
Trial registration: Current Controlled Trials ISRCTN4503220
Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions
No full textBackground: A number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin randomised controlled trials (RCTs). However, the diverse ways in which context may challenge the central tenets of the RCT, and the degree to which this information is known to researchers or subsequently reported, has received much less attention. In this paper, we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity, and across diverse contexts. Methods: This in-depth multiple case study using interviews, focus groups and documentary analysis was conducted in two phases. In phase one, a RCT of a nurse-led intervention provided a single exploratory case and informed the design, sampling and data collection within the main study. Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention. A total of eighty-four data sources across the seven trials were accessed. Results: We present consistent empirical evidence across all trials to indicate that four key elements of context (personal, organisational, trial and problem context) are crucial to understanding how a complex intervention works and to enable both assessments of internal validity and likely generalisability to other settings. The ways in which context challenged trial operation was often complex, idiosyncratic, and subtle; often falling outside of current trial reporting formats. However, information on such issues appeared to be available via first hand 'insider accounts' of each trial suggesting that improved reporting on the role of context is possible. Conclusions: Sufficient detail about context needs to be understood and reported in RCTs of complex interventions, in order for the transferability of complex interventions to be assessed. Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed. In addition, a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and researcher integrity, rather than a symbol of a poor quality study or investigator ability
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