Quality of patient-reported outcome reporting in trials of diabetes in pregnancy: A systematic review.

AIMS: Patient-reported outcomes (PROs) are reports of the patient's health status that come directly from the patient without interpretation by the clinician or anyone else. They are increasingly used in randomised controlled trials (RCTs). In this systematic review we identified RCTs conducted in women with diabetes in pregnancy which included PROs in their primary or secondary outcomes. We then evaluated the quality of PRO reporting against an internationally accepted reporting framework (Consolidated Standards of Reporting Trials (CONSORT-PRO) guidelines). METHODS: We searched online databases for studies published 2013-2021 using a combination of keywords. Two authors reviewed all abstracts independently. Data on study characteristics and the quality of PRO reporting were extracted from relevant studies. We conducted a multiple regression analysis to identify factors associated with high quality reporting. RESULTS: We identified 7122 citations. Thirty-five articles were included for review. Only 17% of RCTs included a PRO as a primary or secondary outcome. Out of a maximum score of 100 the median score was 46, indicating sub-optimal reporting. A multiple regression analysis did not reveal any factors associated with high quality reporting. CONCLUSIONS: Researchers should be mindful of the importance of PRO inclusion and reporting and include reliable PROs in trials.

A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.

OBJECTIVE: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). DESIGN: A consensus developmental study. SETTING: International. POPULATION: Two hundred and five stakeholders completed the first round. METHODS: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. MAIN OUTCOME MEASURES: All outcomes were extracted from the literature. RESULTS: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. CONCLUSIONS: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. TWEETABLE ABSTRACT: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.

Diabetes care and pregnancy outcomes for women with pregestational diabetes in Ireland.

AIMS: Pre-gestational diabetes mellitus (PGDM) is associated with adverse outcomes. We aimed to examine pregnancies affected by PGDM; report on these pregnancy outcomes and compare outcomes for patients with type 1 versus type 2 diabetes mellitus; compare our findings to published Irish and United Kingdom (UK) data and identify potential areas for improvement. METHODS: Between 2016 and 2018 information on 679 pregnancies from 415 women with type 1 Diabetes Mellitus and 244 women with type 2 diabetes was analysed. Data was collected on maternal characteristics; pregnancy preparation; glycaemic control; pregnancy related complications; foetal and maternal outcomes; unscheduled hospitalisations; congenital anomalies and perinatal deaths. RESULTS: Only 15.9% of women were adequately prepared for pregnancy. Significant deficits were identified in availability and attendance at pre-pregnancy clinic, use of folic acid, attaining appropriate glycaemic targets and appropriate retinal screening. The majority of pregnancies (n = 567, 83.5%) resulted in a live birth but the large number of infants born large for gestational age (LGA) (n = 280, 49.4%), born prematurely <37 weeks and requiring neonatal intensive care unit (NICU) admission continue to be significant issues. CONCLUSIONS: This retrospective cohort study identifies multiple targets for improvements in the provision of care to women with pre-gestational DM which are likely to translate into better pregnancy outcomes.

An Irish National Diabetes in Pregnancy Audit: aiming for best outcomes for women with diabetes.

AIMS: The purpose of this study was to identify the number of pregnancies affected by pre-gestational diabetes in the Republic of Ireland; to report on pregnancy outcomes and to identify areas for improvement in care delivery and clinical outcomes. METHODS: Healthcare professionals caring for women with pre-gestational diabetes during pregnancy were invited to participate in this retrospective study. Data pertaining to 185 pregnancies in women attending 15 antenatal centres nationally were collected and analysed. Included pregnancies had an estimated date of delivery between 1 January and 31 December 2015. RESULTS: The cohort consisted of 122 (65.9%) women with Type 1 diabetes and 56 (30.3%) women with Type 2 diabetes. The remaining 7 (3.8%) pregnancies were to women with maturity-onset diabetes of the young (MODY) (n = 6) and post-transplant diabetes (n = 1). Overall women were poorly prepared for pregnancy and lapses in specific areas of service delivery including pre-pregnancy care and retinal screening were identified. The majority of pregnancies 156 (84.3%) resulted in a live birth. A total of 103 (65.5%) women had a caesarean delivery and 58 (36.9%) infants were large for gestational age. CONCLUSIONS: This audit identifies clear areas for improvement in delivery of care for women with diabetes in the Republic of Ireland before and during pregnancy.

Lessons learned from lifestyle prevention trials in gestational diabetes mellitus.

Gestational diabetes mellitus (GDM) is associated with an increased risk of adverse outcomes for mother and infant both at birth and later in life. A large body of evidence is now available relating to antenatal prevention of GDM. Overall, despite some individual trials of a variety of lifestyle interventions revealing benefit, many more have shown no effect from the second trimester onwards, even with significant gestational weight gain limitation. At-risk women often seem reluctant to engage in lifestyle changes and frequently cannot adhere to recommended interventions even within a clinical trial setting. Many trials have not considered the heterogeneity of diabetes first discovered in pregnancy, something of importance into the future. Future work should focus on designing interventions acceptable to the population at risk, whether those taking place before or during the first trimester of pregnancy are effective, and whether greater individualization can identify those women most likely to benefit.

Diabetes in pregnancy: worse medical outcomes in type 1 diabetes but worse psychological outcomes in gestational diabetes.

BACKGROUND: Women with diabetes experience an increased risk of adverse pregnancy outcomes. AIM: We aim to describe and quantify the psychological impact of the diagnosis of diabetes in pregnant women with type 1 diabetes and gestational diabetes mellitus (GDM) compared to each other and to their counterparts without diabetes. DESIGN: This is a survey-based study with prospective collection of pregnancy outcome data. METHODS: A total of 218 pregnant women (50% with diabetes) were administered questionnaires relating to psychological health. Maternal and neonatal characteristics and pregnancy outcomes were collected. Associations between key psychometric and health outcome variables were examined. RESULTS: At least 25% of women in all three pregnancy groups had scores indicating affective distress in at least one domain. Compared to those with type 1 diabetes, women with GDM evidenced a greater number of uplifts in pregnancy (U = 94, P = 0.041), but also higher levels of overall anxiety (U = 92, P = 0.03) and stress (U = 82, P < 0.01). Women with GDM also had significantly elevated overall depression scores, compared with the control group (U = 34, P = 0.02). Both groups of women with diabetes had clinically elevated levels of diabetes-related distress. There were no associations between maternal psychological variables and pregnancy outcomes. CONCLUSIONS: This work highlights a potential role for targeted psychological interventions to address and relieve symptoms of anxiety and depression among pregnant women with diabetes.

Care of women with diabetes before, during and after pregnancy: time for a new approach?

AIMS: This study assesses the impact of pregnancy and pre-pregnancy care on longer-term treatment goals in women with diabetes. METHODS: This retrospective study included women with Type 1 (n = 247) and Type 2 diabetes (n = 137) who were evaluated before, during and after pregnancy. RESULTS: Among women with Type 1 diabetes, average HbA1c at 12 months post-partum was similar to the preconception level [63 vs. 64 mmol/mol (7.9% vs. 8.0%), P = 0.60]. This was also the case for women with Type 2 diabetes [52 vs. 52 mmol/mol (6.9% vs. 6.9%), P = 0.79]. At 12 months post-partum, there was no improvement in other measures of diabetes control and one in five women are lost to follow-up from clinical care. In total, 44.9% of women with Type 1 diabetes and 27.7% of those with Type 2 diabetes attended pre-pregnancy care. Attendees maintained superior glycaemic control throughout the study and were more likely to be receiving specialist care post-partum. CONCLUSIONS: These findings identify a need to change our approach to the reproductive care of women with diabetes. In particular, efforts should be made to ensure all women have access to and attend pre-pregnancy care, and barriers to engagement with post-partum care should be addressed.

Maternal supplementation of seaweed-derived polysaccharides improves intestinal health and immune status of suckling piglets.

The experiment investigated the effect of maternal dietary supplementation of seaweed-derived polysaccharides (SDP) (-SDP v. +SDP, n   20) from day 83 of gestation until weaning (day 28) on selected sow faeces and piglet digesta microbiota populations, piglet small-intestinal morphology, and intestinal nutrient transporter and inflammatory cytokine gene expression at birth, 48 h after birth and weaning. The effect of maternal dietary treatment on the piglet gene expression profile of inflammatory cytokines in the colon following a lipopolysaccharide (LPS) challenge was also investigated. Dietary SDP reduced sow faecal Enterobacteriaceae gene numbers at parturition. Small-intestinal morphology, nutrient transporter and cytokine gene expression in newborn piglets did not differ between maternal dietary treatments (P > 0·10). At 48 h after birth, sodium-glucose-linked transporter 1 gene expression was down-regulated in the ileum of piglets suckling the SDP-supplemented sows compared with those suckling the basal sows (P = 0·050). There was a SDP × LPS challenge interaction on IL-1 and IL-6 gene expression in the colon of piglets (P < 0·05). The gene expression of IL-1 and IL-6 was down-regulated in the LPS-challenged colon of piglets suckling the SDP sows compared with those suckling the basal sows (P < 0·05). However, there was no difference in IL-1 and IL-6 gene expression in the unchallenged colon between treatment groups. At weaning, piglets suckling the SDP-supplemented sows had increased villus height in the jejunum and ileum compared with those suckling the basal-fed sows (P < 0·05). In conclusion, maternal dietary SDP supplementation enhanced the immune response of suckling piglets and improved gut morphology, making them more immune competent to deal with post-weaning adversities.

Postpartum glucose testing for women with gestational diabetes mellitus: Improving regional recall rates.

Our aim was to evaluate attendance for postpartum glucose testing among women attending five antenatal centres with a diagnosis of GDM in the preceding pregnancy. A central, regional coordinator who made verbal and written contact with each individual facilitated a favourable recall rate of 75%.

The management of type 1 and type 2 diabetes in pregnancy.

Pregestational diabetes is a common medical complication of pregnancy and preconception planning is an essential component of care for affected women of childbearing age. Once pregnant, structured care in a multidisciplinary team setting is necessary to ensure optimal outcomes. Although significant progress has been made, these women and their offspring remain to have a significantly elevated risk of multiple adverse complications. Structured programmes using information technology and enabling access to novel technologies may facilitate our goal of ensuring an outcome closer to that of a pregnancy unaffected by diabetes.

Malignant pleural effusion.

Malignant pleural effusion (MPE) refers to the presence of neoplastic cells in the pleural fluid. Approximately 40 000 people per year in the UK are affected by MPE and it is associated with significant morbidity and an overall poor prognosis. Management should be prompt and care plans should be individualized and involve a multidisciplinary team of healthcare professionals. This article reviews the pathophysiology of MPE along with available investigations and management strategies for these patients.

Barriers to exercise in obese patients with type 2 diabetes.

BACKGROUND: Although regular exercise is a critical component of the management of type 2 diabetes, many patients do not meet their exercise targets. Lack of exercise is associated with obesity and adverse cardiovascular outcomes. AIM: We aimed to assess exercise habits in obese Irish patients with type 2 diabetes to determine if patients are adhering to exercise guidelines and to identify perceived barriers to exercise in this group. DESIGN: A cross-sectional study of obese patients with type 2 diabetes attending routine outpatient diabetes clinics at our institution, a public teaching hospital located on the outskirts of Dublin City. METHODS: A total of 145 obese patients with type 2 diabetes were administered a questionnaire to evaluate exercise habits and perceived barriers to exercise. Anthropometric details were measured. RESULTS: About 47.6% (n = 69) of patients exercised for <150 minutes per week (40% of males, 62% of females; P = 0.019) and these patients had a higher body mass index than those meeting targets (35 vs. 33.5 kg/m(2); P = 0.02). Perceived barriers to exercise were varied, with lack of time and physical discomfort being the most common. Reported barriers to exercise varied with age, gender and marital status. CONCLUSION: This study highlights the challenges facing clinicians in improving exercise levels in patients, and the need to identify the specific barriers to exercise in the individual to improve health outcomes.

The prevalence of diabetes, pre-diabetes and the metabolic syndrome in an Irish regional homeless population.

BACKGROUND: Diabetes is a major chronic health condition. Prevalence is rising, superseding public health estimates. Chronic diseases are more common among lower socioeconomic groups, for example, the homeless population. There is paucity of data on the health status of the homeless population in Ireland, and the prevalence of diabetes and associated cardiovascular risk factors is unknown. AIM: We aimed to assess the prevalence of diabetes, pre-diabetes and the metabolic syndrome (MetS) in an Irish regional homeless population. DESIGN: This study is a cross-sectional study of the homeless population living in a regional university city of Ireland. METHODS: After informed consent and following an overnight fast, blood was drawn for fasting plasma glucose, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein and glycosylated haemoglobin (HbA1c). A 75 g glucose load was given orally and an oral glucose tolerance test completed. Anthropometric measurements and blood pressure were recorded. Smoking, alcohol and drug status were noted. RESULTS: Of the 252 participants, 8% (n = 20), 10% (n = 24) and 21% (n = 54) were diagnosed with type 2 diabetes, pre-diabetes and MetS, respectively. Obesity (body mass index >30) was present in 22%, while 90% displayed abdominal obesity. Participants who screened positive for diabetes, pre-diabetes and MetS demonstrated an inferior cardiovascular risk profile. CONCLUSION: The prevalence of diabetes, pre-diabetes and MetS in this homeless population is in keeping with national estimates. As this cohort is less likely to seek health care, this may result in later diagnosis and a greater risk of diabetic complications at presentation.

Burkholderia pseudomallei activates complement and is ingested but not killed by polymorphonuclear leukocytes.

The mechanism by which Burkholderia pseudomallei is resistant to lysis by human serum is unknown but may include interference with complement activation, effective opsonization, or complement-mediated lysis. We investigated the interaction of B. pseudomallei with complement in the presence and absence of specific antibody to determine potential mechanisms of serum resistance. We demonstrated rapid activation and consumption of complement by B. pseudomallei which, in the absence of specific antibody, occurred predominantly via the alternative pathway. Complement activation was associated with deposition of the opsonically active C3b and iC3b fragments on the bacterial surface. C5b-9, detected on the bacterial surface after opsonic periods of 1 to 60 min, was susceptible to elution by 1 M NaCl, indicating that resistance to complement-mediated lysis may result from deposition of the membrane attack complex in a nonmicrobicidal location. To define the role of opsonins, we investigated the ability of polymorphonuclear leukocytes (PMNL) to phagocytose B. pseudomallei. Phagocytosis of bacteria by PMNL, and the observed oxidative response, was significantly increased by opsonization of organisms with complement and/or specific antibody. Despite opsonophagocytosis by PMNL and the production of an oxidative response, no significant bacterial killing was observed.

Expandable metal stents for tracheobronchial obstruction.

We report our experience of the use of endoscopically inserted expanding stainless steel stents in 18 patients over a period of 31 months. Twelve patients had stents inserted for malignant disease causing narrowing of the tracheobronchial tree, and six for airway complications following heart-lung, single lung or double lung transplantation. In all but one case, stents were satisfactorily positioned, and there were no complications related to stent insertion. Seven patients were alive at follow-up, three of whom had stents inserted for malignancy and four as a result of complications following transplantation.

Factors associated with the initiation of "smoking" in nine year old children.

The present study examined the relationship between 787 (415 boys and 372 girls) nine year old children's reported experience with cigarettes and the parents, home environment, peers, socioeconomic status, school performance and behavior or emotional problems and delinquency factors which had in the past been found to be influential during the formative stages of initiation into the use of tobacco. The 787 children (415 boys and 372 girls) were classified as either "puffers" (those who had puffed on a cigarette) or nonpuffers. The results suggest than, at age nine, puffers were more likely than nonpuffers to: intend to smoke in the future; have one or both parents smoking; have one, or more, smoking friend(s); do less well at maths and school work in general; misbehave more often; and be taken to see a psychologist regarding a behavioral or emotional problem.