Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review

Abstract

BackgroundAcute appendicitis is the most common surgical emergency in children. Despite this, there is no core outcome set (COS) described for randomised controlled trials (RCTs) in children with appendicitis and hence no consensus regarding outcome selection, definition and reporting. We aimed to identify outcomes currently reported in studies of paediatric appendicitis.MethodsUsing a defined, sensitive search strategy, we identified RCTs and systematic reviews (SRs) of treatment interventions in children with appendicitis. Included studies were all in English and investigated the effect of one or more treatment interventions in children with acute appendicitis or undergoing appendicectomy for presumed acute appendicitis. Studies were reviewed and data extracted by two reviewers. Primary (if defined) and all other outcomes were recorded and assigned to the core areas ‘Death’, ‘Pathophysiological Manifestations’, ‘Life Impact’, ‘Resource Use’ and ‘Adverse Events’, using OMERACT Filter 2.0.ResultsA total of 63 studies met the inclusion criteria reporting outcomes from 51 RCTs and nine SRs. Only 25 RCTs and four SRs defined a primary outcome. A total of 115 unique and different outcomes were identified. RCTs reported a median of nine outcomes each (range 1 to 14). The most frequently reported outcomes were wound infection (43 RCTs, nine SRs), intra-peritoneal abscess (41 RCTs, seven SRs) and length of stay (35 RCTs, six SRs) yet all three were reported in just 25 RCTs and five SRs. Common outcomes had multiple different definitions or were frequently not defined. Although outcomes were reported within all core areas, just one RCT and no SR reported outcomes for all core areas. Outcomes assigned to the ‘Death’ and ‘Life Impact’ core areas were reported least frequently (in six and 15 RCTs respectively).ConclusionsThere is a wide heterogeneity in the selection and definition of outcomes in paediatric appendicitis, and little overlap in outcomes used across studies. A paucity of studies report patient relevant outcomes within the ‘Life Impact’ core area. These factors preclude meaningful evidence synthesis, and pose challenges to designing prospective clinical trials and cohort studies. The development of a COS for paediatric appendicitis is warranted.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0783-1) contains supplementary material, which is available to authorized users.

A Core Outcome Set for Children With Feeding Tubes and Neurologic Impairment: A Systematic Review

“…This finding has been described in other populations, including children with appendicitis, 19 esophagectomy, 125 inguinal hernia repair, 126 and pediatric acute diarrheal diseases. 127 Taken together, this heterogeneity and variability provide a strong rationale for the creation of a COS for children with neurologic impairment living with G-/GJ-tubes.…”

“…19 Therefore, to ensure consistency throughout our process, we merged outcomes with similar definitions or themes regardless of their terminology. For example, child growth as an outcome can be defined and measured through study-specific outcomes (eg, weightfor-age z scores), generic outcomes (eg, growth), and abstract constructs (eg, parent perception of their child's weight).…”

“…To assess heterogeneity in outcome selection and/or reporting among articles rather than outcome data, we employed visual and qualitative inspection of an outcome matrix 13,19 instead of parametric tests. Outcome matrices are graphical representations of outcome inclusion among a series of articles, whereby each reviewed article is stacked across the x-axis, and all outcomes are listed on the y-axis.…”

“…Similar to COS development in other populations, the OMERACT Filter 2.0 has been identified as a strong framework for the extraction of outcomes to be used in a COS, as well as to organize and present the final COS. 19 Now that the evidence synthesis is complete, all 120 outcomes extracted through this systematic review will form the foundation of the development of a COS.…”

Outcome reporting in randomized controlled trials of major depressive disorder treatments in adolescents: a systematic scoping review protocol

“…We will classify an outcome as a 'primary outcome' when studies explicitly report at least one of the following: (1) a study outcome is explicitly referred to as a 'primary outcome'; (2) outcome data was used to calculate sample size; or (3) study objective explicitly included examining an intervention effect on that outcome. 46 Notably, multiple primary outcomes are commonly reported in depression RCTs. 47 After data charting, the identified outcomes will be synthesized and grouped through assignment to thematic 'outcome terms', as appropriate, consistent with the development of other COS. 20 46 For example, the outcomes 'psychosocial improvement' and 'level of functioning at school, home, and in the community' could be grouped under the outcome term 'social functioning'.…”