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This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:To assess the effectiveness and safety of antidepressant drugs in comparison with any other treatment (psychological, psychosocial, or pharmacological), placebo, or treatment as usual for PND.
Background Although many treatments exist for phantom limb pain (PLP), the evidence supporting them is limited and there are no guidelines for PLP management. Brain and spinal cord neurostimulation therapies are targeted at patients with chronic PLP but have yet to be systematically reviewed. Objective To determine which types of brain and spinal stimulation therapy appear to be the best for treating chronic PLP. Design Systematic reviews of effectiveness and epidemiology studies, and a survey of NHS practice. Population All patients with PLP. Interventions Invasive interventions – deep brain stimulation (DBS), motor cortex stimulation (MCS), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation. Non-invasive interventions – repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). Main outcome measures Phantom limb pain and quality of life. Data sources Twelve databases (including MEDLINE and EMBASE) and clinical trial registries were searched in May 2017, with no date limits applied. Review methods Two reviewers screened titles and abstracts and full texts. Data extraction and quality assessments were undertaken by one reviewer and checked by another. A questionnaire was distributed to clinicians via established e-mail lists of two relevant clinical societies. All results were presented narratively with accompanying tables. Results Seven randomised controlled trials (RCTs), 30 non-comparative group studies, 18 case reports and 21 epidemiology studies were included. Results from a good-quality RCT suggested short-term benefits of rTMS in reducing PLP, but not in reducing anxiety or depression. Small randomised trials of tDCS suggested the possibility of modest, short-term reductions in PLP. No RCTs of invasive therapies were identified. Results from small, non-comparative group studies suggested that, although many patients benefited from short-term pain reduction, far fewer maintained their benefits. Most studies had important methodological or reporting limitations and few studies reported quality-of-life data. The evidence on prognostic factors for the development of chronic PLP from the longitudinal studies also had important limitations. The results from these studies suggested that pre-amputation pain and early PLP intensity are good predictors of chronic PLP. Results from the cross-sectional studies suggested that the proportion of patients with severe chronic PLP is between around 30% and 40% of the chronic PLP population, and that around one-quarter of chronic PLP patients find their PLP to be either moderately or severely limiting or bothersome. There were 37 responses to the questionnaire distributed to clinicians. SCS and DRG stimulation are frequently used in the NHS but the prevalence of use of DBS and MCS was low. Most responders considered SCS and DRG stimulation to be at least sometimes effective. Neurosurgeons had mixed views on DBS, but most considered MCS to rarely be effective. Most clinicians thought that a randomised trial design could be successfully used to study neurostimulation therapies. Limitation There was a lack of robust research studies. Conclusions Currently available studies of the efficacy, effectiveness and safety of neurostimulation treatments do not provide robust, reliable results. Therefore, it is uncertain which treatments are best for chronic PLP. Future work Randomised crossover trials, randomised N-of-1 trials and prospective registry trials are viable study designs for future research. Study registration The study is registered as PROSPERO CRD42017065387. Funding The National Institute for Health Research Health Technology Assessment programme.
Background Consistent and appropriate measurement is needed in order to improve understanding and evaluation of preventative interventions. This review aims to identify individual-level measurement tools used to evaluate mental health prevention interventions to inform harmonization of outcome measurement in this area. Methods Searches were conducted in PubMed, PsychInfo, CINAHL, Cochrane and OpenGrey for studies published between 2008 and 2018 that aimed to evaluate prevention interventions for common mental health problems in adults and used at least one measurement scale (PROSPERO CRD42018095519). For each study, mental health measurement tools were identified and reviewed for reliability, validity, ease-of-use and cultural sensitivity. Results A total of 127 studies were identified that used 65 mental health measurement tools. Most were used by a single study (57%, N = 37) and measured depression (N = 20) or overall mental health (N = 18). The most commonly used questionnaire (15%) was the Centre for Epidemiological Studies Depression Scale. A further 125 tools were identified which measured non-mental health-specific outcomes. Conclusions There was little agreement in measurement tools used across mental health prevention studies, which may hinder comparison across studies. Future research on measurement properties and acceptability of measurements in applied and scientific settings could be explored. Further work on supporting researchers to decide on appropriate outcome measurement for prevention would be beneficial for the field.
Background: Responsibility for public health in England transferred from the National Health Service to local authorities in 2013, representing a different decision-making environment. Systematic reviews are considered the gold standard of evidence for clinical decision-making but little is known about their use in local government public health. This study aimed to explore the extent to which public health decision-makers in local authorities engage with systematic reviews and how they do so. Methods: Semi-structured interviews were conducted with senior public health practitioners (n = 14) in Yorkshire and the Humber local authorities. Sampling was purposive and involved contacting Directors of Public Health directly and snowballing through key contacts. Face-to-face or telephone interviews were digitally recorded, transcribed verbatim and analysed using the Framework Method. Results: Public health practitioners described using systematic reviews directly in decision-making and engaging with them more widely in a range of ways, often through a personal commitment to professional development. They saw themselves as having a role to advocate for the use of rigorous evidence, including systematic reviews, in the wider local authority. Systematic reviews were highly valued in principle and public health practitioners had relevant skills to find and appraise them. However, the extent of use varied by individual and local authority and was limited by the complexity of decision-making and various barriers. Barriers included that there were a limited number of systematic reviews available on certain public health topics, such as the wider determinants of health, and that the narrow focus of reviews was not reflective of complex public health decisions facing local authorities. Reviews were used alongside a range of other evidence types, including grey literature. The source of evidence was often considered an indicator of quality, with specific organisations, such as Public Health England, NICE and Cochrane, particularly trusted. Conclusions: Research use varies and should be considered within the specific decision-making and political context. There is a need for systematic reviews to be more reflective of the decisions facing local authority public health teams.
The Centre for Reviews and Dissemination and Centre for Health Economics Technology Assessment Group at the University of York was commissioned by the National Institute for Health and Care Excellence (NICE) Highly Specialised Technologies (HST) programme to act as the independent Evidence Review Group (ERG) for an appraisal of Strimvelis ® , a gene therapy treatment for adenosine deaminase deficiency–severe combined immunodeficiency (ADA-SCID). This paper describes the manufacturing company’s submission of clinical and economic evidence, the ERG’s review and the resulting NICE guidance. For Strimvelis ® compared with haematopoietic stem cell transplant (HSCT) from a matched unrelated donor (MUD) and HSCT from a haploidentical donor, the company base-case deterministic incremental cost-effectiveness ratios (ICERs) were £36,360 and £14,645 per quality-adjusted life-year (QALY) gained, respectively (using a discount rate of 1.5%). Although overall survival in patients receiving Strimvelis ® was substantially higher than historical comparator data on HSCT from a MUD or haploidentical donor, the ERG was concerned that the estimated treatment benefit remained highly uncertain. The ERG critiqued some assumptions in the cost-effectiveness model, including that all patients return to general population mortality and morbidity after a successful procedure; that all patients receive a matched sibling donor following an unsuccessful engraftment; and that differences in wait times exist between the treatments. Incorporating a number of changes to the model, the ERG’s base-case ICERs were £86,815 per QALY gained for Strimvelis ® compared with HSCT from a MUD and £16,704 per QALY gained compared with HSCT from a haploidentical donor (using a discount rate of 1.5%). The ICER for Strimvelis ® compared with HSCT from a MUD was highly sensitive to the difference in procedural mortality and could exceed NICE’s £100,000 per QALY gained threshold for HSTs, if HSCT survival rates have improved since the most recent data. The evaluation committee concluded that the most plausible ICERs were lower than £100,000 per QALY gained and that Strimvelis ® should be recommended for treatment of ADA-SCID where a matched related donor is unavailable.
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:To assess the effectiveness and safety of antidepressant drugs in comparison with any other treatment (psychological, psychosocial, or pharmacological), placebo, or treatment as usual for PND.
As part of the National Institute for Health and Care Excellence single technology appraisal process, brodalumab was assessed to determine the clinical and cost effectiveness of its use in the treatment of moderate-to-severe plaque psoriasis. The Centre for Reviews and Dissemination and the Centre for Health Economics Technology Assessment Group at the University of York were commissioned to act as the independent Evidence Review Group. This article provides a summary of the Evidence Review Group's review of the company's submission, the Evidence Review Group report and the National Institute for Health and Care Excellence Appraisal Committee's subsequent guidance issued in March 2018. The main clinical effectiveness data were derived from three well-conducted, multicentre, double-blind randomised controlled trials. The trials demonstrated that brodalumab statistically significantly reduced the severity of psoriasis and its impact on health-related quality of life, compared with placebo, at 12 weeks. In comparison with ustekinumab, statistically significantly more patients taking brodalumab had reduced psoriasis severity at 12 weeks. Psoriasis severity and quality of life also appeared improved at 52 weeks, although statistical significance was not assessed. Withdrawal rates were comparable to drug survival rates of other biological therapies and rates of adverse events were similar between brodalumab and ustekinumab. A network meta-analysis was presented, comparing brodalumab with other therapies available at the same point in the treatment pathway (i.e. in patients for whom standard systemic therapy or phototherapy is inadequately effective, not tolerated or contraindicated). The network meta-analysis ranked treatments in order of effectiveness, in terms of achieving different levels of Psoriasis Area and Severity Index response. The results indicated that brodalumab had a similar probability of response to ixekizumab, secukinumab and infliximab and a higher probability of response than ustekinumab, adalimumab, etanercept, apremilast, dimethyl fumarate and placebo. The company's economic model compared nine treatment sequences that included three lines of active therapy, consisting of brodalumab and other comparators recommended by the National Institute for Health and Care Excellence, followed by best supportive care. The sequence with brodalumab in the first-line position dominated sequences that started with adalimumab, infliximab, secukinumab and ustekinumab. The incremental cost-effectiveness ratio of the brodalumab sequence compared to less effective and non-dominated sequences ranged from £7145 (vs. the etanercept sequence) to £13,353 (vs. the dimethyl fumarate sequence) per quality-adjusted life-year gained. The incremental cost-effectiveness ratio for the more costly and effective ixekizumab sequence was £894,010 per quality-adjusted life-year gained compared to the brodalumab sequence. At a threshold of £20,000 per quality-adjusted life-year gained, the brodalumab sequence had the highest probability ...
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