Global Prevalence of Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis

1. Abstract 1.1. Background: Evidence suggests that diabetes in all forms are on the rise especially gesta-tional diabetes mellitus which increases the risk of maternal and neonatal morbidities; however global prevalence rates and geographical distribution of GDM remain uncertain. The aim of this study is to examine the global burden of gestational diabetes mellitus. 1.2. Methods: A systematic review and meta-analysis of studies reporting Randomised Clinical Trials (RCTs) in pregnant women who have GDM was conducted. Cochrane (Central), PubMed, Scopus, JBI, Medline, EMBASE and reference lists of retrieved studies were searched from inception to March 2019. Publications on prevalence of GDM irrespective of the baseline criteria used to diagnose GDM were included in the study. Studies were limited to English language, randomised control trials and women aged between 19-44 years inclusive. 1.3. Results: Eleven RCTs met the inclusion criteria for this review. The included studies collectively reported GDM rates of 13,450 pregnant women from 7 countries. The diagnostic criteria used in the studies were World Health Organisation (WHO) 1985 and 1999, International Association of Diabetes, Pregnancy Study Group (IADPSG), National Diabetes Data Group (NDDG), Carpenter-Coustan (C&C) and O'Sullivan's criteria. Seven RCTs screened for GDM in comparison with different diagnostic criteria in the same population while three studies used the same criteria for different groups. One study compared 100g, 3h OGTT to 75g, 2h OGTT for diagnosing GDM using Carpenter and Coustan criteria. All seven RCTs that compared different diagnostic criteria in the same population detected different prevalence rates of GDM. Three RCTs measured prevalence of GDM in the same population using WHO 1999 and IADPSG 2013 criteria. Using random effect model, data from three studies that compared IADPSG criteria to WHO 1999 showed an Odds Ratio (OR) of 0.52(0.15, 1.84), 95% Confidence Interval (CI) and high heterogeneity of 99%. In all three studies, prevalence of GDM measured by IADPSG criteria was higher than WHO 1999 criteria, although not significant (p= 0.31). Combining all the studies gave a global estimated prevalence of GDM to be 10.13% (95% CI, 7.33-12.94) with moderate heterogeneity of 27%. The highest prevalence of GDM wit

Adaptation of the Wound Healing Questionnaire universal-reporter outcome measure for use in global surgery trials (TALON-1 study): mixed-methods study and Rasch analysis

BackgroundThe Bluebelle Wound Healing Questionnaire (WHQ) is a universal-reporter outcome measure developed in the UK for remote detection of surgical-site infection after abdominal surgery. This study aimed to explore cross-cultural equivalence, acceptability, and content validity of the WHQ for use across low- and middle-income countries, and to make recommendations for its adaptation.MethodsThis was a mixed-methods study within a trial (SWAT) embedded in an international randomized trial, conducted according to best practice guidelines, and co-produced with community and patient partners (TALON-1). Structured interviews and focus groups were used to gather data regarding cross-cultural, cross-contextual equivalence of the individual items and scale, and conduct a translatability assessment. Translation was completed into five languages in accordance with Mapi recommendations. Next, data from a prospective cohort (SWAT) were interpreted using Rasch analysis to explore scaling and measurement properties of the WHQ. Finally, qualitative and quantitative data were triangulated using a modified, exploratory, instrumental design model.ResultsIn the qualitative phase, 10 structured interviews and six focus groups took place with a total of 47 investigators across six countries. Themes related to comprehension, response mapping, retrieval, and judgement were identified with rich cross-cultural insights. In the quantitative phase, an exploratory Rasch model was fitted to data from 537 patients (369 excluding extremes). Owing to the number of extreme (floor) values, the overall level of power was low. The single WHQ scale satisfied tests of unidimensionality, indicating validity of the ordinal total WHQ score. There was significant overall model misfit of five items (5, 9, 14, 15, 16) and local dependency in 11 item pairs. The person separation index was estimated as 0.48 suggesting weak discrimination between classes, whereas Cronbach's α was high at 0.86. Triangulation of qualitative data with the Rasch analysis supported recommendations for cross-cultural adaptation of the WHQ items 1 (redness), 3 (clear fluid), 7 (deep wound opening), 10 (pain), 11 (fever), 15 (antibiotics), 16 (debridement), 18 (drainage), and 19 (reoperation). Changes to three item response categories (1, not at all; 2, a little; 3, a lot) were adopted for symptom items 1 to 10, and two categories (0, no; 1, yes) for item 11 (fever).ConclusionThis study made recommendations for cross-cultural adaptation of the WHQ for use in global surgical research and practice, using co-produced mixed-methods data from three continents. Translations are now available for implementation into remote wound assessment pathways