Summary of Study Characteristics.

<p>* Number of neonates enrolled in the study who had simple gastroschisis and a comparison of outcomes for SR vs. OPFC</p><p>** Study intervention that was used as a comparator to OPFC</p><p>^# Bradnock 2011 reports one year follow-up data for the patients enrolled in the Owen 2010 study. Both studies are included here as they report different outcomes. However we have only used data from one of the two reports in each outcome analysis.</p><p>Summary of Study Characteristics.</p

Challenges of Improving the Evidence Base in Smaller Surgical Specialties, as Highlighted by a Systematic Review of Gastroschisis Management

<div><p>Objective</p><p>To identify methods of improving the evidence base in smaller surgical specialties, using a systematic review of gastroschisis management as an example.</p><p>Background</p><p>Operative primary fascial closure (OPFC), and silo placement with staged reduction and delayed closure (SR) are the most commonly used methods of gastroschisis closure. Relative merits of each are unclear.</p><p>Methods</p><p>A systematic review and meta-analysis was performed comparing outcomes following OPFC and SR in infants with simple gastroschisis. Primary outcomes of interest were mortality, length of hospitalization and time to full enteral feeding.</p><p>Results</p><p>751 unique articles were identified. Eight met the inclusion criteria. None were randomized controlled trials. 488 infants underwent OPFC and 316 underwent SR. Multiple studies were excluded because they included heterogeneous populations and mixed intervention groups. Length of stay was significantly longer in the SR group (mean difference 8.97 days, 95% CI 2.14–15.80 days), as was number of post-operative days to complete enteral feeding (mean difference 7.19 days, 95%CI 2.01–12.36 days). Mortality was not statistically significantly different, although the odds of death were raised in the SR group (OR 1.96, 95%CI 0.71–5.35).</p><p>Conclusions</p><p>Despite showing some benefit of OPFC over SR, our results are tempered by the low quality of the available studies, which were small and variably reported. Coordinating research through a National Paediatric Surgical Trials Unit could alleviate many of these problems. A similar national approach could be used in other smaller surgical specialties.</p></div

Forest plots showing the effect of SR on key secondary outcome measures.

<p>Forest plots showing the effect of SR on key secondary outcome measures.</p

Number of unique clinical trials/systematic reviews registered for each condition (number with direct surgical relevance).

<p>Number of unique clinical trials/systematic reviews registered for each condition (number with direct surgical relevance).</p

Study flow diagram.

<p>Study flow diagram.</p

Summary Outcome Measures for Silo Repair in Neonates with Simple Gastroschisis.

<p>* The basis for the <b>assumed risk</b> (e.g. the median control group risk across studies) is provided in footnotes. The <b>corresponding risk</b> (and its 95% confidence interval) is based on the assumed risk in the comparison group and the <b>relative effect</b> of the intervention (and its 95% CI).</p><p><b>CI:</b> Confidence interval; <b>OR:</b> Odds ratio;</p><p>GRADE Working Group grades of evidence <b>High quality:</b> Further research is very unlikely to change our confidence in the estimate of effect. <b>Moderate quality:</b> Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. <b>Low quality:</b> Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. <b>Very low quality:</b> We are very uncertain about the estimate.</p><p>¹ Allocation to SR in Tsai 2010 and Rodriguez 2009 was based upon failure of OPFC, suggesting that an element of selection bias may enter into the analysis.</p><p>² Three small studies with lower quality methodology favour OPFC whilst the one large study with more robust methodology favours SR.</p><p>³ Cumulative sample size is less than the optimal information size (OIS) and the 95% confidence interval for the pooled effect crosses the line of harm, the line of no effect and the line of benefit.</p><p>⁴ Cumulative sample size is less than the OIS and the 95% confidence intervals for the pooled data crosses both the line of benefit and line of no effect</p><p>Summary Outcome Measures for Silo Repair in Neonates with Simple Gastroschisis.</p

Forest plots showing the effect of SR on primary outcome measures.

<p>Forest plots showing the effect of SR on primary outcome measures.</p