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om, highdose antihistamines, adrenaline autoinjector prescription and training Study design Randomised controlled trials Systematic reviews Outes Oute measures to be considered include: number and severity of type 1 IgEmediated systemic allergic reactions mortality anxiety related to the possibility of future allergic reactions adverse effects of treatment healthrelated quality of life Other considerations If the evidence allows, considerations will be given to subgroups of people, according to their: risk of future stings (as determined, for example, by occupational exposure) risk of severe allergic reactions to future stings (as determined by such factors as baseline tryptase levels and comorbidities) If the evidence allows, the appraisal will consider separately people who have a contraindication to adrenaline. If the evidence allows, the appraisal will consider children separately. Two reviewers will independently screen all titles and abstracts of papers identified in the initial search. Discrepancies will be resolved by consensus and where necessary a third reviewer will be consulted. Studies deemed to be relevant will be obtained and assessed for inclusion. Where studies do not meet the inclusion criteria they will be excluded. Data extraction strategy Data relating to study design, findings and quality will be extracted by one reviewer and independently checked for accuracy by a second reviewer. Study details will be extracted using a standardised data extraction form. If time permits, attempts will be made to contact authors for missing data. Data from studies presented in multiple publications will be extracted and reported as a single study with all relevant other publications listed. Quality assessment strategy The quality of the clinicaleffectiveness studies will be assessed according to criteria based on the CRD’s guidance for undertaking reviews in The quality of the individual clinicaleffectiveness studies will be assessed by one reviewer, and independently checked for agreement by a second. Disagreements will be resolved through consensus and if necessary a third reviewer will be consulted. Methods of analysis/synthesis The results of the data extraction and quality assessment for each study will be presented in structured tables and as a narrative summary. The possible effects of study quality on the effectiveness data and review findings will be discussed. All summary statistics will be extracted for each oute and where possible, data will be pooled using a standard Heterogeneity between the studies will be assessed using the I2 Both fixed and random effects results will be presented as forest plots.6 METHODS FOR SYNTHESISING COST EFFECTIVENESS EVIDENCE The economic section of the report will be presented in two parts. The first will include a standard review of relevant published economic evaluations. If appropriate and data are available, the second will include the development of an economic model. The model will be designed to estimate the cost effectiveness of Pharmalgen174。 for VIT in patients with a history of allergic reactions to bee or wasp venom. Other searching activities, including electronic searching of online health economic journals and contacting experts in the field will also be undertaken. Full details of the search process will be presented in the final report. The search strategy will be designed to meet the primary objective of identifying economic evaluations for inclusion in the costeffectiveness literature review. At the same time, the search strategy will be used to identify economic evaluations and other information sources which may include data that can be used to populate a de novo economic model where appropriate. Searching will be undertaken in MEDLINE and EMBASE as well as in the Cochrane Library, which includes the NHS Economic Evaluation Database (NHS EED). Inclusion and exclusion In addition to the inclusion criteria outlined in Table 1, specific criteria required for the costeffectiveness review are described in Table 2. In particular, only full economic evaluations that pare two or more options and consider both costs and consequences will be included in the review of published literature. Any economic evaluations/models included in the manufacturer submission(s) will be included as appropriate. Studies that do not meet all of the criteria will be excluded and their bibliographic details listed with reasons for exclusion. Table 2: Additional inclusion criteria (cost effectiveness) Study design Full economic evaluations that consider both costs and consequences (costeffectiveness analysis, costutility analysis, costminimisation analysis and cost benefit analysis) Outes Incremental cost per life year gained Incremental cost per quality adjusted life year gained Data extraction strategy Data relating to both study design and quality will be extracted by one reviewer and independently checked for accuracy by a second reviewer. Disagreement will be resolved through consensus and, if necessary, a third reviewer will be consulted. If time constraints allow, attempts will be made to contact authors for missing data. Data from multiple publications will be extracted and reported as a single study. Quality assessment strategy The quality of the costeffectiveness studies/models will be assessed according to a checklist updated from that developed by Drummond et This checklist will reflect the criteria for economic evaluation detailed in the methodological guidance developed by The quality of the individual costeffectiveness studies/models will be assessed by one reviewer, and independently checked for agreement by a second. Disagreements will be resolved through consensus and, if necessary, a third reviewer will be consulted. The information will be tabulated and summarised within the text of the report. Methods of analysis/synthesis Cost effectivene