228 research outputs found

    NI1 The UK Nice Single Technology Appraisal Process: A Qualitative Study Based on Manufacturers' Submissions

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    Amblyopia and quality of life: a systematic review

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    Background/Aims Amblyopia is a common condition which can affect up to 5% of the general population. The health-related quality of life (HRQoL) implications of amblyopia and/or its treatment have been explored in the literature. Methods A systematic literature search was undertaken (16th-30th January 2007) to identify the HRQoL implications of amblyopia and/or its treatment. Results A total of 25 papers were included in the literature review. The HRQoL implications of amblyopia related specifically to amblyopia treatment, rather than the condition itself. These included the impact upon family life; social interactions; difficulties undertaking daily activities; and feelings and behaviour. The identified studies adopted a number of methodologies. The study populations included; children with the condition; parents of children with amblyopia; and adults who had undertaken amblyopia treatment as a child. Some studies developed their own measures of HRQoL, and others determined HRQoL through proxy measures. Conclusions The reported findings of the HRQoL implications are of importance when considering the management of cases of amblyopia. Further research is required to assess the immediate and long-term effects of amblyopia and/or its treatment upon HRQoL using a more standardised approach

    Clinical and cost-effectiveness of capecitabine and tegafur with uracil for the treatment of metastatic colorectal cancer: systematic review and economic evaluation

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    Objectives: To evaluate the clinical and costeffectiveness of capecitabine and tegafur with uracil (UFT/LV) as first-line treatments for patients with metastatic colorectal cancer, as compared with 5- fluorouracil/folinic acid (5-FU/FA) regimens. Data sources: Electronic databases, reference lists of relevant articles and sponsor submissions were also consulted. Review methods: Systematic searches, selection against criteria and quality assessment were performed to obtain data from relevant studies. Costs were estimated through resource-use data taken from the published trials and the unpublished sponsor submissions. Unit costs were taken from published sources, where available. An economic evaluation was undertaken to compare the cost-effectiveness of capecitabine and UFT/LV with three intravenous 5- FU/LV regimens widely used in the UK: the Mayo, the modified de Gramont regimen and the inpatient de Gramont regimens. Results: The evidence suggests that treatment with capecitabine improves overall response rates and has an improved adverse effect profile in comparison with 5-FU/LV treatment with the Mayo regimen, with the exception of hand–foot syndrome. Time to disease progression or death after treatment with UFT/LV in one study appears to be shorter than after treatment with 5-FU/LV with the Mayo regimen, although it also had an improved adverse effect profile. Neither capecitabine nor UFT/LV appeared to improve healthrelated quality of life. Little information on patient preference was available for UFT/LV, but there was indicated a strong preference for this over 5-FU/LV. The total cost of capecitabine and UFT/LV treatments were estimated at £2111 and £3375, respectively, compared with the total treatment cost for the Mayo regimen of £3579. Cost estimates were also presented for the modified de Gramont and inpatient de Gramont regimens. These were £3684 and £6155, respectively. No survival advantage was shown in the RCTs of the oral drugs against the Mayo regimen. Cost savings of capecitabine and UFT/LV over the Mayo regimen were estimated to be £1461 and £209, respectively. Drug acquisition costs were higher for the oral therapies than for the Mayo regimen, but were offset by lower administration costs. Adverse event treatment costs were similar across the three regimens. It was inferred that there was no survival difference between the oral drugs and the de Gramont regimens. Cost savings of capecitabine and UFT/LV over the modified de Gramont regimen were estimated to be £1353 and £101, respectively, and over the inpatient de Gramont regimen were estimated to be £4123 and £2870, respectively. Conclusions: The results show that there are cost savings associated with the use of oral therapies. No survival difference has been proven between the oral drugs and the Mayo regimen. In addition, no evidence of a survival difference between the Mayo regimen and the de Gramont regimens has been identified. However, improved progression-free survival and an improved adverse event profile have been shown for the de Gramont regimen over the Mayo regimen. Further research is recommended into the following areas: quality of life data should be included in trials of colorectal cancer treatments; the place of effective oral treatments in the treatment of colorectal cancer, the safety mechanisms needed to ensure compliance and the monitoring of adverse effects; the optimum duration of treatment; the measurement of patient preference; and a phase III comparative trial of capecitabine and UFT/LV versus modified de Gramont treatment to determine whether there was any survival advantage and to collate the necessary economic data

    Barriers and Facilitators to the Implementation of Interventions to Prevent Youth Violence in Latin America: A Systematic Review and Qualitative Evidence Synthesis

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    Youth violence in Latin America is an important public health problem. However, the evidence from preventive programs within the region to address this problem is limited. Identifying context-specific factors that facilitate or hinder the success of interventions is necessary to guarantee the successful implementation of new preventive strategies. We present a systematic review and synthesis of qualitative studies to identify factors affecting the implementation of programs to prevent youth violence in Latin America. We searched 10 electronic databases and websites of international institutions. The quality of the studies was assessed using the critical appraisal skills program checklist, while the certainty of the findings of the synthesis was assessed using the certainty of the qualitative evidence approach. We included eight papers describing five programs in Argentina, Venezuela, Peru, El Salvador, and Mexico. Most of the factors affecting the implementation of programs were aspects related to features of the programs and social/political constraints. The synthesis suggests that future programs can benefit from having a multidisciplinary and/or multisectoral approach involving different key players. At the same time, potential strategies for avoiding problems related to such active engagement should be planned via promoting effective channels for communication and supervision. The review also suggests the importance of increasing awareness and motivation toward the problem of youth violence among relevant agencies and stakeholders. While the limited volume and quality of the literature impact on the ability to draw conclusions, the results could be useful for new programs being designed and the ones seeking to be adapted from other contexts

    Choice and judgement in developing models for health technology assessment; a qualitative study

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    Introduction: The role of models in supporting health policy decisions is reliant on model credibility. Credibility is fundamentally determined by the choices and judgements that people make in the process of developing a model. However, the method of uncovering choices and making judgements in model development is largely unreported and is not addressed by modelling methods guidance. Methods: This qualitative study was part of a project examining errors in health technology assessment models. In-depth interviews with academic and commercial modellers were used to obtain descriptions of the model development process. Data were analysed using framework analysis and interpreted in the context of the methodological literature. Results: The activities involved in developing models were characterised according to the themes; understanding the decision problem, conceptual modelling, model implementation, model checking, and engaging with the decision maker. Finding and using evidence was frequently mentioned across these themes. There was marked variation between practitioners in the extent to which conceptual modelling was recognised as an activity distinct from model implementation. Discussion: Methodological approaches to addressing model credibility described in the wider modelling literature highlight the necessity to disentangle the conceptual modelling and implementation activities. Whilst interviewees talked of judgements and choice making throughout model development, discussion indicated that these were based upon skills and experience with no discussion of formal approaches. Methods are required that provide for a systematic approach to uncovering choices, to generating a shared view of consensus and divergence, and for making judgements and choices in model development

    Methods for a rapid systematic review and meta-analysis in evaluating selective serotonin reuptake inhibitors for premature ejaculation

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    The aim of this study was to evaluate a rapid systematic review method in which randomised controlled trial (RCT) data was extracted from existing reviews and subsequent RCTs. The method enabled: identification of RCTs not included by existing reviews; cross-checking RCT data for consistency where there was more than one review; double data extraction due to time saved by extracting data from existing reviews; correction of data synthesis errors in existing reviews; and pooling data across all RCTs to produce contemporary effect estimates. When subsequently compared to extracting data directly from all RCT original publications, the findings and conclusions concurred

    Meta-review of the effectiveness of computerised CBT in treating depression

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    <p>Abstract</p> <p>Background</p> <p>Several computerised cognitive behaviour therapy (cCBT) packages are now available to treat mild to moderate depression with or without anxiety. These have been usually been reviewed alongside cCBT for a wide range of psychological problems. Here, we single out the results of these reviews for the most common mental disorder, mild to moderate depression. The aim of this paper is to evaluate the quality of existing reviews and to enable reliable comparisons of alternative computer packages for the same patient group.</p> <p>Methods</p> <p>A thorough search and analysis of reviews of efficacy of cCBT published between 1999 and February 2011.</p> <p>Results</p> <p>The search yielded twelve systematic reviews from ten studies covering depression. Their methodology is appraised and selected findings are presented here.</p> <p>Conclusions</p> <p>The meta-review supports the efficacy of cCBT for treatment of depression; however there is limited information on different approaches, whose relative cost-effectiveness remains to be demonstrated. Suggestions are made for future studies in the field.</p

    Health-related quality-of-life of coal-based sponge iron plant workers in Barjora, India: a cross-sectional study

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    OBJECTIVES: During the last decade, coal-based sponge iron plants, a highly polluted industry, have grown rapidly in Barjora, India. Understanding their workers’ perception of health is essential in people-centered healthcare. The aim of the study was to assess their health-related quality-of-life (HRQoL), and to determine factors that independently predict their HRQoL. DESIGN: Cross-sectional study. SETTING: Coal-based sponge iron plants in Barjora, India. PARTICIPANTS: 258 coal-based sponge iron plant workers. PRIMARY OUTCOME MEASURE: HRQoL was measured using the EuroQol-5D-5L. RESULTS: The response rate was 100%. Participants with problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 23.3%, 5.1%, 10.9%, 39.5% and 45.5%, respectively. 36.8% of participants reported health state 11111 (no problem in any EQ-5D dimension). The mean visual analogue scale (EQ-VAS) was 69.8 (18.5 SD). The odds of mobility problems decreased with age (OR 0.95, 95% CI 0.91 to 0.99, p=0.016), were lower in participants with presence/history of any respiratory disease (0.27, 0.13 to 0.55, p<0.001), scheduled caste/scheduled tribe/other backward class workers (0.44, 0.22 to 0.89, p=0.021), manual workers (0.40, 0.16 to 0.99, p=0.047) and non-smokers (2.63, 1.27 to 5.46, p=0.009). The odds of pain/discomfort and anxiety/depression were lower in participants with any respiratory disease (0.44, 0.24 to 0.79, p=0.006; and 0.52, 0.29 to 0.92, p=0.026, respectively). The EQ-VAS was worse in manual participants (coefficient −6.91, 95% CI −12.40 to −1.41, p=0.014), with any respiratory disease (−8.13, −13.12 to −3.13, p=0.002), alcohol drinkers (−4.81, −9.47 to −0.15, p=0.043), literates (7.70, 0.97 to 14.43, p=0.025) and Hindus (13.41, 2.62 to 24.20, p=0.015). CONCLUSIONS: Many coal-based sponge iron plant workers in Barjora have problems in their HRQoL, and the predictors of different aspects of HRQoL were identified. The study findings could be taken into consideration in future interventional studies aimed at improving the HRQoL of these workers

    The effectiveness of sexual health interventions for people with severe mental illness: a systematic review

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    BACKGROUND: Severe mental illnesses (SMIs), such as schizophrenia and bipolar disorder, persist over time and can cause extensive disability leading to impairments in social and occupational functioning. People with SMI have higher morbidity and mortality due to physical illness than the general population and may be more likely to engage in high-risk sexual behaviour (e.g. unprotected intercourse, having multiple partners, involvement in the sex trade and illicit drug use), putting them at risk of poorer sexual health outcomes including sexually transmitted infections. Sexual health promotion interventions, developed and implemented for people with SMI, may improve participants' knowledge, attitudes, beliefs or behavioural practices and could lead to a reduction in risky sexual behaviour. OBJECTIVES: To evaluate the effectiveness of sexual health interventions for people with SMI compared with usual care and their applicability to the UK NHS setting. DATA SOURCES: Thirteen electronic databases were searched from inception to December 2012. All controlled trials (randomised or non-randomised) that met the following criteria were included: any sexual health promotion intervention or combination of interventions intended to change the knowledge, attitudes, beliefs, behaviours or practices of individuals with SMI (defined as adults aged ≥ 18 years who have received a diagnosis of schizophrenia or bipolar disorder) living in the community. REVIEW METHODS: A systematic review of the clinical evidence was undertaken following recommended guidelines. Data were tabulated and discussed in a narrative review. RESULTS: Thirteen randomised controlled studies met the inclusion criteria. The methodological quality of the included studies varied considerably, with only a minority of studies (n = 2) being considered as having very few methodological limitations. Despite wide variations in the study populations, interventions, comparators and outcomes, four studies showed significant improvements in all measured sexual risk behaviour outcomes (e.g. human immunodeficiency virus knowledge and behaviour change) in the intervention groups compared with the control groups. In contrast, four studies found significant improvements in the intervention groups for some outcomes only and three studies found significant improvements in certain subgroups only, based on either gender or ethnicity. Finally, two studies reported no significant differences in any sexual risk behaviour outcomes between the intervention and control groups. Moreover, positive findings were not consistently sustained at follow-up in many studies. LIMITATIONS: Little detail was provided in the studies regarding the content of interventions, how they were delivered and by whom, making replication or generalisability difficult. CONCLUSIONS: Owing to the large between-study variability (especially in the populations, interventions, comparators and reported outcomes) and mixed results, there is insufficient evidence to fully support or reject the identified sexual health interventions for people with SMI. In addition, there are considerable uncertainties around the generalisability of these findings to the UK setting. Further research recommendations include well-designed, UK-based trials of sexual health interventions for people with SMI as well as training and support for staff implementing sexual health interventions. STUDY REGISTRATION: PROSPERO number CRD42013003674. FUNDING: The National Institute for Health Research Health Technology Assessment Programme

    A case study of binary outcome data extraction across three systematic reviews of hip arthroplasty: errors and differences of selection.

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    BACKGROUND: Data extraction is a key stage in systematic review, yet it is the subject of little research. The aim of the present research was to use a small case study to highlight some important issues affecting this fundamental process. METHODS: The authors undertook an analysis of differences in the binary event data extracted and analysed by three systematic reviews on the same topic: a comparison of total hip arthroplasty and hemiarthroplasty. The following binary event data were extracted for three key outcomes, common to all three reviews, from those trials common to all three reviews: Dislocation rates, 1-year mortality, and revision rates. Differences between the data extracted by the three reviews were categorised as either errors or an issue of data selection. Meta-analysis was performed to assess whether these differences led to differences in summary estimates of effect. RESULTS: Across the three outcomes, differences in selection accounted for between 8% and 42% of the data differences between reviews, and errors accounted for between 8% and 17%. No rationale was given in any of these former cases for the choice of event data being reported. These differences did lead to small differences in meta-analysed relative risks between the two treatments in the three reviews, but none was significant. CONCLUSIONS: Systematic reviewers should use double-data extraction to minimise error and also make every effort to clarify or explain their choice of data, within the scope of their publication. Reviewers frequently exercise selection when faced with a choice of alternative but potentially equally appropriate data for an outcome. However, this selection is rarely made clear by review authors. Systematic review was developed as a method specifically to be both reproducible and transparent. This case study suggests that neither objective is always being achieved
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