Syed et al. BMC Public Health 2011, 11(Suppl 3):S2 http://www.biomedcentral.com/1471-2458/11/S3/S2 Page 6 of 12 Table 1 Quality grading of outcomes according to the CHERG approach using adapted GRADE criteria No of Design studies (ref) Limitations Consistency Generalizability to population of interest Generalizability to Intervention Control Relative intervention of Risk interest (95% CI) Intensified versus conventional management (Stillbirths): MODERATE outcome specific quality 4 3 RCTs,1 quasi RCT Small study size in 1 study, 1 2/4 studies showing All in developed Cannot separate diet study not strictly randomized direction of benefit, countries controlled from diet and 80% of the subjects while the remaining and insulin were Hispanic so may not be two had zero total controlled diabetes generalizable. events during pregnancy 1 8 RR (fixed) = 0.20 (0.03- 1.10) women. Initial hospitalization, intensive monitoring and management in one group were compared to only two weeks of intensive management in the group that enrolled late. Positive effect was seen on rates of stillbirth in patients with GDM and pregestational diabetes [Still- birth: GDM (RR=0.23, 95%CI 0.12-0.47), type 1 diabetes (RR=0.32, 95%CI 0.15-0.72), type 2 diabetes (RR=0.077, 95%CI 0.019-0.32)]. Three observational studies assessed women for dia- betes during pregnancy followed by treatment for those who tested positive. Those who were tested positive and treated were the compared to those that tested negative. [27,54,64] A retrospective cohort by Koukkou et al. 1995 [54] tested high risk women for GDM, followed by comparison of outcomes between women who tested positive with those that did not. No significant impact on stillbirth rates was seen (RR 2.08, 95% CI 0.19-22.7). Similar results were seen in a cohort study by Philipson et al 1985 [64] who compared women who tested posi- tive for GDM versus those who did not. A study by Beischer et al compared women who tested positive for GDM versus those that were normal. This study screened the population for gestational diabetes and assessed effect on perinatal mortality. The study also gave data on difference in mild and severe gestational diabetes. It reported a decreasing trend in stillbirth rates between 1971 and 1994. Applying CHERG Rules for Evidence Reviews for LiST, we gave a ‘moderate’ level quality evidence for the impact of intensified versus conventional management on stillbirths [8]. The total number of events was less than 50 (Rule 0 applies) and so there is insufficient evi- dence to recommend this estimate for the LiST model. One of the studies was quasi randomized [13] and another [24] had a small sample size from which con- clusions could not be drawn. We, therefore, use the Delphi results to make a recommendation for the inter- vention of diabetes screening and management. (4) Optimal versus suboptimal glucose control Four observational studies [26,42,61,70] focused on the comparison of optimal control of serum glucose versus suboptimal control. Two studies [42,70] reported data on stillbirths and three [26,61,70] had data on perinatal mortality. Pooled data from these studies did not display a significant difference in risk of stillbirth (RR=0.51, 95% CI 0.14-1.88) (figure 3). However, perinatal mortality was significantly reduced (RR=0.40, 95% CI 0.25- 0.63) (figure 4). For the comparison of optimal versus suboptimal con- trol of diabetes two cohort studies [42,70] reporting stillbirth risk were identified. Of these only one study [70] had adjusted for confounding factors. The outcome of stillbirth was given ‘low’ evidence because these were cohort studies and could not be used for recommending into the LiST tool because the total events were less than 50 (Rule 0 application) [8]. (5) Pre-conception care for pregestational diabetes versus No care/conventional care Four observational studies [29,36,71,74] focused on the impact of preconception care (information about need for optimization of glycemic control before pregnancy, assessment of diabetes complications, review of dietary habits, intensification of capillary blood glucose self-mon- itoring and optimization of insulin therapy) versus no preconception care in pre gestational diabetes. Two of these studies included both type 1 and 2 diabetics [29,74] and the other two focused on type 1 diabetes only [36,71]. Of these 3 studies, one [74] was not adjusted for confounding factors and one was a multicentre cross sec- tional study; the evidence from these trials was deemed to be of ‘moderate’ outcome specific quality. Two studies (Temple et al.2006 [71] and Boulot et al. 2003 [29]) focused on providing intensive preconception care including information about need for optimization of gly- cemic control before pregnancy, assessment of diabetes complications, review of dietary habits, intensification of capillary blood glucose self-monitoring and optimization of insulin therapy. One study [74] focused only on pre- conception counseling. The study by Cyganek et al. 2010 [36] focused on pre pregnancy planning in women who were receiving continuous subcutaneous insulin infusion or multiple daily injections. There were 14 malforma- tions, stillbirths, and perinatal infant deaths in the not- planning versus five in the planning group (P = 0.07).