The “Clinical evidence profile” tables presented summarize the quality of evidence and the findings of the reviews in the guideline. The tables present the pooled outcome data (where appropriate), an absolute measure of intervention effect and the summary of quality of evidence for that outcome. In these tables, the columns for intervention and control indicate the sum of the sample size for continuous outcomes. For binary outcomes such as number of patients with an adverse event, the event rates (n/N: number of patients with events divided by sum of number of patients) are shown with percentages. Reporting or publication bias was only taken into consideration in the quality assessment and included in the Clinical Study Characteristics table if it was apparent. Each outcome was examined separately for the quality elements listed and defined in Table 2 and each graded using the quality levels listed in Table 3 in the full version of the original guideline document. The main criteria considered in the rating of these elements are discussed below (see section 3.3.4, Grading of Evidence, in the full version of the original guideline document). Footnotes were used to describe reasons for downgrading a quality element as having serious or profoundly serious problems. The ratings for each component were summed to obtain an overall assessment for each outcome. Grading the Quality of Clinical Evidence After results were pooled, the overall quality of evidence for each outcome was considered. The following procedure was adopted when using Grading of Recommendations, Assessment, Development and Evaluation (GRADE): A quality rating was assigned, based on the study design. Randomized controlled trials (RCTs) start HIGH and observational studies as LOW, uncontrolled case series as LOW or VERY LOW. The rating was then downgraded for the specified criteria: Study limitations, inconsistency, indirectness, imprecision and reporting bias. These criteria are detailed below. Observational studies were upgraded if there was: a large magnitude of effect, dose-response gradient, and if all plausible confounding would reduce a demonstrated effect or suggest a spurious effect when results showed no effect. Each quality element considered to have “serious” or “very serious” risk of bias was rated down -1 or -2 points, respectively. The downgraded/upgraded marks were then summed, and the overall quality rating was revised. For example, all RCTs started as HIGH and the overall quality became MODERATE, LOW or VERY LOW if 1, 2 or 3 points were deducted, respectively. The reasons or criteria used for downgrading were specified in the footnotes. See the full version of the original guideline document for details about study limitations, inconsistency, indirectness, and imprecision. Evidence Statements Evidence statements were formed for each outcome indicating the quantity and quality of evidence available, and the outcome and population to which they relate. Where possible these were drafted for each subgroup or by outcome. An overall evidence summary for a particular intervention was presented, where possible. Undertaking New Health Economic Analysis As well as reviewing the published economic literature for each review question new economic analysis was undertaken by the health economist in selected areas. Priority areas for new health economic analysis were agreed by the GDG after formation of the review questions and consideration of the available health economic evidence. The GDG identified monitoring, fluid type for resuscitation and fluid type for maintenance as the highest priority areas for original economic modelling (see sections 6.3.1.3, 6.3.2.3 7.2.3.3, 7.3.2, 7.2.4.2 in the full version of the original guideline document). In all three areas, the systematic review did not produce strong enough evidence to evaluate cost-effectiveness, so cost analyses were developed. The following general principles were adhered to: Methods were consistent with the NICE reference case, where possible.
