Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN).

INTRODUCTION: Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes. METHODS AND ANALYSIS: This retrospective cohort and nested case-control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother-infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported. ETHICS AND DISSEMINATION: This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.

Is therapeutic inertia present in hyperglycaemia, hypertension and hypercholesterolaemia management among adults with type 2 diabetes in three health clinics in Malaysia? a retrospective cohort study.

BACKGROUND: Good-quality evidence has shown that early glycaemic, blood pressure and LDL-cholesterol control in people with type 2 diabetes (T2D) leads to better outcomes. In spite of that, diseases control have been inadequate globally, and therapeutic inertia could be one of the main cause. Evidence on therapeutic inertia has been lacking at primary care setting. This retrospective cohort study aimed to determine the proportions of therapeutic inertia when treatment targets of HbA1c, blood pressure and LDL-cholesterol were not achieved in adults with T2D at three public health clinics in Malaysia. METHODS: The index prescriptions were those that when the annual blood tests were reviewed. Prescriptions of medication were verified, compared to the preceding prescriptions and classified as 1) no change, 2) stepping up and 3) stepping down. The treatment targets were HbA1c < 7.0% (53 mmol/mol), blood pressure (BP) < 140/90 mmHg and LDL-cholesterol < 2.6 mmol/L. Therapeutic inertia was defined as no change in the medication use in the present of not reaching the treatment targets. Descriptive, univariable, multivariable logistic regression and sensitive analyses were conducted. RESULTS: A total of 552 cohorts were available for the assessment of therapeutic inertia (78.9% completion rate). The mean (SD) age and diabetes duration were 60.0 (9.9) years and 5.0 (6.0) years, respectively. High therapeutic inertia were observed in oral anti-diabetic (61-72%), anti-hypertensive (34-65%) and lipid-lowering therapies (56-77%), and lesser in insulin (34-52%). Insulin therapeutic inertia was more likely among those with shorter diabetes duration (adjusted OR 0.9, 95% CI 0.87, 0.98). Those who did not achieve treatment targets were less likely to experience therapeutic inertia: HbA1c ≥ 7.0%: adjusted OR 0.10 (0.04, 0.24); BP ≥ 140/90 mmHg: 0.28 (0.16, 0.50); LDL-cholesterol ≥ 2.6 mmol/L: 0.37 (0.22, 0.64). CONCLUSIONS: Although therapeutic intensifications were more likely in the presence of non-achieved treatment targets but the proportions of therapeutic inertia were high. Possible causes of therapeutic inertia were less of the physician behaviours but might be more of patient-related non-adherence or non-availability of the oral medications. These observations require urgent identification and rectification to improve disease control, avoiding detrimental health implications and costly consequences. TRIAL REGISTRATION: Number NCT02730754 , April 6, 2016.