BackgroundControversy exists about how much, if any, weight obese pregnant women should gain. While the revised Institute of Medicine guidelines on gestational weight gain (GWG) in 2009 recommended a weight gain of 5–9 kg for obese pregnant women, many studies suggested even gestational weight loss (GWL) for obese women.ObjectivesA systematic review was conducted to summarize pregnancy outcomes in obese women with GWL compared to GWG within the 2009 Institute of Medicine guidelines (5–9 kg).DesignFive databases were searched from 1 January 2009 to 31 July 2014. The Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA Statement were followed. A modified version of the Newcastle-Ottawa scale was used to assess individual study quality. Small for gestational age (SGA), large for gestational age (LGA) and preterm birth were our primary outcomes.ResultsSix cohort studies were included, none of which assessed preterm birth. Compared to GWG within the guidelines, women with GWL had higher odds of SGA <10th percentile (adjusted odds ratio [AOR] 1.76; 95% confidence interval [CI] 1.45–2.14) and SGA <3rd percentile (AOR 1.62; 95% CI 1.19–2.20) but lower odds of LGA >90th percentile (AOR 0.57; 95% CI 0.52–0.62). There was a trend towards a graded relationship between SGA <10th percentile and each of three obesity classes (I: AOR 1.73; 95% CI 1.53–1.97; II: AOR 1.63; 95% CI 1.44–1.85 and III: AOR 1.39; 95% CI 1.17–1.66, respectively).ConclusionDespite decreased odds of LGA, increased odds of SGA and a lack of information on preterm birth indicate that GWL should not be advocated in general for obese women.

A systematic review was conducted to determine the risk of adverse pregnancy outcomes with gestational weight gain (GWG) below the 2009 Institute of Medicine guidelines compared with within the guidelines in obese women. MEDLINE, Embase, Cochrane Register, CINHAL and Web of Science were searched from 1 January 2009 to 31 July 2014. Quality was assessed using a modified Newcastle-Ottawa scale. Three primary outcomes were included: preterm birth, small for gestational age (SGA) and large for gestational age (LGA). Eighteen cohort studies were included. GWG below the guidelines had higher odds of preterm birth (adjusted odds ratio [AOR] 1.46; 95% confidence interval [CI] 1.07-2.00) and SGA (AOR 1.24; 95% CI 1.13-1.36) and lower odds of LGA (AOR 0.77; 95% CI 0.73-0.81) than GWG within the guidelines. Across the three obesity classes, the odds of SGA and LGA did not show any notable gradient and remained unexplored for preterm birth. Decreased odds were noted for macrosomia (AOR 0.64; 95% CI 0.54-0.77), gestational hypertension (AOR, 0.70; 95% CI 0.53-0.93), pre-eclampsia (AOR 0.90; 95% CI 0.82-0.99) and caesarean (AOR 0.87; 95% CI 0.82-0.92). GWG below the guidelines cannot be routinely recommended but might occasionally be individualized for certain women, with caution, taking into account other known risk factors.

BackgroundExcess gestational weight gain (GWG), which has reached epidemic proportions, is associated with adverse outcomes during pregnancy and postpartum obesity in women and children. Psychological variables represent potentially modifiable factors. Moreover, previous systematic reviews on GWG interventions have called for the need for a clearer understanding of psychological factors affecting GWG. Hence, a systematic review was conducted to summarize the relation between psychological factors and GWG.MethodsEight databases were searched, and the guidelines on Preferred Reporting Items for Systematic Reviews and Meta-Analyses were followed. Methodological quality of the included studies was assessed using a modified Newcastle-Ottawa scale. Two assessors independently reviewed titles, abstracts and full articles, extracted data and assessed quality.ResultsA total of 6198 titles and abstracts were reviewed of which 90 full text articles were retrieved. Thirty-five studies (25 cohort, eight cross-sectional and two case–control) met the inclusion criteria, assessing 26 different psychological constructs in affect, cognitions and personality. Negative affective states such as depression, anxiety and stress were not related to excess GWG. Among weight-related and dietary-related cognitions, risk factors for excess GWG included concern about weight gain, negative body image and attitude towards weight gain, inaccurate perceptions regarding weight, higher than recommended target weight gain, less knowledge about weight gain, higher levels of cognitive dietary restraint, and perceived barriers to healthy eating. Protective factors included an internal locus of control for weight gain, lower than recommended target weight gain and higher self-efficacy for healthy eating. Only one study examined the relation between personality and excess GWG.ConclusionIn this systematic review, a number of cognitive factors were identified that were associated with excess GWG. To address excess GWG, more high quality, adequately powered studies are required examining cognitions, motivation and personality factors.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-015-0535-y) contains supplementary material, which is available to authorized users.

CONTEXT: Uncertainty exists about the impacts of feeding tubes on neurologically impaired children. Core outcome sets (COS) standardize outcome selection, definition, measurement, and reporting. OBJECTIVE:To synthesize an evidence base of qualitative data on all outcomes selected and/ or reported for neurologically impaired children 0 to 18 years living with gastrostomy/ gastrojejunostomy tubes. DATA EXTRACTION: Outcomes were extracted and assigned to modified Outcome Measures in Rheumatology 2.0 Filter core areas; death, life impact, resource use, pathophysiological manifestations, growth and development. RESULTS:We identified 120 unique outcomes with substantial heterogeneity in definition, measurement, and frequency of selection and/or reporting: "pathophysiological manifestation" outcomes (n = 83) in 79% of articles; "growth and development" outcomes (n = 13) in 55% of articles; "death" outcomes (n = 3) and "life impact" outcomes (n = 17) in 39% and 37% of articles, respectively; "resource use" outcomes (n = 4) in 14%. Weight (50%), gastroesophageal reflux (35%), and site infection (25%) were the most frequently reported outcomes. LIMITATIONS:We were unable to investigate effect size of outcomes because quantitative data were not collected. CONCLUSIONS:The paucity of outcomes assessed for life impact, resource use and death hinders meaningful evidence synthesis. A COS could help overcome the current wide heterogeneity in selection and definition. These results will form the basis of a consensus process to produce a final COS.

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.

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Background: Complete and transparent reporting of clinical trial protocols and reports ensures that these documents are useful to all stakeholders, that bias is minimized, and that the research is not wasted. However, current studies repeatedly conclude that pediatric trial protocols and reports are not appropriately reported. Guidelines like SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) may improve reporting, but do not offer guidance on issues unique to pediatric trials. This paper reports two systematic reviews conducted to build the evidence base for the development of pediatric reporting guideline extensions: 1) SPIRIT-Children (SPIRIT-C) for pediatric trial protocols, and 2) CONSORT-Children (CONSORT-C) for pediatric trial reports. Method: MEDLINE, the Cochrane Methodology Register, and reference lists of included studies were searched. Publications of any type were eligible if they included explicit recommendations or empirical evidence for the reporting of potential items in a pediatric protocol (SPIRIT-C systematic review) or trial report (CONSORT-C systematic review). Study characteristics, recommendations and evidence for pediatric extension items were extracted. Recurrent themes in the recommendations and evidence were identified and synthesized. All steps were conducted by two reviewers. Results: For the SPIRIT-C and CONSORT-C systematic reviews 366 and 429 publications were included, respectively. Recommendations were identified for 48 of 50 original reporting items and sub-items from SPIRIT, 15 of 20 potential SPIRIT-C reporting items, all 37 original CONSORT items and sub-items, and 16 of 22 potential CONSORT-C reporting items. The following overarching themes of evidence to support or refute the utility of reporting items were identified:

IntroductionPaediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting.Methods and analysisThis project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders.Ethics and DisseminationThis protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly developed with all relevant stakeholders, will be disseminated through peer-reviewed journals as well as national and international conference presentations. Endorsement of the checklist will be sought simultaneously in multiple journals.