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Scope and methodology




                           Table 1.2  Levels of evidence for studies of the accuracy of diagnostic tests 26

                           Level        Type of evidence
                                                                     a
                           Ia           Systematic review (with homogeneity)  of level-1 studies b
                           Ib           Level-1 studies b
                                                   c
                           II           Level-2 studies ; systematic reviews of level-2 studies
                           III          Level-3 studies ; systematic reviews of level-3 studies
                                                   d
                           IV           Consensus, expert committee reports or opinions and/or clinical experience without
                                        explicit critical appraisal; or based on physiology, bench research or ‘first principles’
                           a   Homogeneity means there are no or minor variations in the directions and degrees of results between individual
                            studies that are included in the systematic review.
                           b   Level-1 studies are studies that use a blind comparison of the test with a validated reference standard (gold standard)
                            in a sample of patients that reflects the population to whom the test would apply.
                           c   Level-2 studies are studies that have only one of the following:
                            • narrow population (the sample does not reflect the population to whom the test would apply)
                            • use a poor reference standard (defined as that where the ‘test’ is included in the ‘reference’, or where the ‘testing’
                             affects the ‘reference’)
                            • the comparison between the test and reference standard is not blind
                            • case–control studies.
                           d   Level-3 studies are studies that have at least two or three of the features listed above.



                           Evidence  was  synthesised  qualitatively  by  summarising  the  content  of  identified  papers  in  a
                           narrative manner with brief statements accurately reflecting the evidence and producing evidence
                           tables. Quantitative synthesis (meta-analysis) was performed where appropriate.

                           Summary results and data are presented in the guideline text. More detailed results and data are
                           presented in the evidence tables on the accompanying CD-ROM. Where possible, dichotomous
                           outcomes are presented as relative risks (RRs) with 95% confidence intervals (CIs), and continuous
                           outcomes are presented as weighted mean differences (WMDs) with 95% CIs.

               1.7.3       Health economics

                           The aim of the economic input in this guideline was to inform the GDG of potential economic
                           issues relating to the management of dehydration in children, and to ensure that recommendations
                           represented a cost-effective use of scarce resources.
                           It is not possible to perform economic analysis for every clinical question and therefore some
                           prioritisation is necessary, along the lines suggested in the NICE Technical Manual.  Some of
                                                                                                   26
                           the clinical questions do not involve a comparison of alternative courses of action (for example,
                           What factors are associated with an increased risk of dehydration?) and are not amenable to
                           economic analysis. For some questions addressing laboratory investigations, the GDG accepted
                           that  these  often  did  not  need  to  be  routinely  undertaken  because  such  routine  investigation
                           would not be cost-effective, as they rarely affect management or health outcomes.
                           It  was  thought  by  the  GDG  that  economic  analysis  would  be  important  in  formulating
                           recommendations for the following two clinical questions:
                           •  How do oral rehydration therapy (ORT) and intravenous fluid therapy (IVT) compare in terms
                             of safety and efficacy, in the treatment of dehydration?
                           •  Which interventions (other than fluid therapy and antibiotic treatment) are effective and safe?
                           The  health  economics  for  the  latter  question  focused  on  oral  ondansetron,  an  anti-emetic
                           treatment.
                           A systematic search for published economic evidence was undertaken for these questions. For
                           economic evaluations, no standard system of grading the quality of evidence exists and included
                           papers were assessed using a quality assessment checklist based on good practice in decision-
                           analytic modelling. Reviews of the limited relevant published economic literature are presented
                                           35
                           as part of the appendix detailing the original economic analysis.




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