Angela O’Dea

An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial

BackgroundUniversal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM.Methods/DesignA total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n = 27) or to the Croí MyAction intervention group (n = 27). The control arm receives usual health care advice - written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on glucose dysfunction, comparing a mean reduction in fasting plasma glucose (FPG) levels on a 75 gram oral glucose tolerance test (OGTT) in the two groups at a one-year, post-intervention follow-up. The trial is funded by the Irish Health Research Board (HRB). Ethics approval was obtained on 27 March 2012 from the Clinical Research Ethics Committee, Galway University Hospitals, Health Service Executive of Ireland (Ref: C.A.691).Trial registrationCurrent Controlled Trials ISRCTN41202110.

Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial

BackgroundThe risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings.Methods/DesignThis will be an unblinded, two-group, parallel randomised controlled trial (RCT). The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland: Galway University Hospital and Mayo General Hospital. Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care (n = 392) or secondary care (n = 392) locations. The primary outcome variable is the uptake rate of screening. Secondary outcomes include indicators of clinical effectiveness of screening at each screening site (primary and secondary) including gestational week at time of screening, time to access antenatal diabetes services for women diagnosed with GDM, and pregnancy and neonatal outcomes for women with GDM. In addition, parallel economic and qualitative evaluations will be conducted. The trial will cover the period from the woman’s first hospital antenatal visit at 12 to 18 weeks gestation, until the completion of the pregnancy.Trial registrationCurrent Controlled Trials: ISRCTN02232125

The cost-effectiveness of screening for gestational diabetes mellitus in primary and secondary care in the Republic of Ireland

Aims/hypothesisThe aim of the study was to assess the cost-effectiveness of screening for gestational diabetes mellitus (GDM) in primary and secondary care settings, compared with a no-screening option, in the Republic of Ireland.MethodsThe analysis was based on a decision-tree model of alternative screening strategies in primary and secondary care settings. It synthesised data generated from a randomised controlled trial (screening uptake) and from the literature. Costs included those relating to GDM screening and treatment, and the care of adverse outcomes. Effects were assessed in terms of quality-adjusted life years (QALYs). The impact of the parameter uncertainty was assessed in a range of sensitivity analyses.ResultsScreening in either setting was found to be superior to no screening, i.e. it provided for QALY gains and cost savings. Screening in secondary care was found to be superior to screening in primary care, providing for modest QALY gains of 0.0006 and a saving of €21.43 per screened case. The conclusion held with high certainty across the range of ceiling ratios from zero to €100,000 per QALY and across a plausible range of input parameters.Conclusions/interpretationThe results of this study demonstrate that implementation of universal screening is cost-effective. This is an argument in favour of introducing a properly designed and funded national programme of screening for GDM, although affordability remains to be assessed. In the current environment, screening for GDM in secondary care settings appears to be the better solution in consideration of cost-effectiveness.

Screening for gestational diabetes mellitus in primary versus secondary care: The clinical outcomes of a randomised controlled trial.

AIMS To examine the clinical outcomes of screening for gestational diabetes mellitus (GDM) in primary care versus secondary care, in the Irish healthcare system. DESIGN AND METHODS A parallel group randomised controlled trial (RCT) of screening for GDM in primary versus secondary care was used to examine (i) prevalence, (ii) gestational week of screen, (iii) time to access specialist care, and (iv) maternal and neonatal outcomes. In total 781 women were recruited for screening in primary care (n=391) or secondary care (n=390). RESULTS The prevalence of GDM and gestational week of screen were similar in both locations. There was a trend towards a longer time to access diabetes care in primary care (24days) versus secondary care (19days), a difference of 5days (p=0.09). Women screened in primary care also showed a trend towards a higher rate of large for gestational age (LGA) infants (20%) than those screened in secondary care (14.7%), (p=0.09). There were no differences between groups in maternal outcomes. CONCLUSIONS This RCT suggests that screening for GDM in secondary care may be associated with potentially faster time to access specialist antenatal diabetes care and possibly lower LGA rates. Further research is needed to clarify these findings and to improve the delay in accessing specialist care requires an urgent focus. Further research is needed to test these findings in other health systems.

Is Crew Resource Management Training Effective in Healthcare Settings

The healthcare industry has seen a recent proliferation in the adoption of team training, such as crew resource management (CRM). Empirical studies of the effectiveness of CRM-type training in healthcare were subjected to meta-analysis. Fourteen CRM evaluation studies were found to fulfill the a priori criteria for inclusion in the meta-analysis. The metrics of CRM training effectiveness analyzed were: reactions, attitudes, knowledge, behaviors, and organization. CRM trained participants responded positively to CRM, the training had large effects on the participants’ knowledge and behaviors, and a medium effect on their attitudes. The training was also found to have a medium effect on the number of errors/adverse events and a small effect on the time to complete clinical tasks. Although there are methodological limitations that mean the results from this study should be treated with a little caution, the findings are nevertheless encouraging.

Excuse me: teaching junior doctors to speak up.

A consistent finding in healthcare is that juniors are unwilling to ‘speak up’ to seniors. Training designed to encourage junior doctors to speak up was designed, delivered, and evaluated. The training was constructed around filmed stories of senior doctors describing situations in which their communication and assertiveness skills were challenged. A total of 110 interns attended the training. The feedback from participants was positive. There was a significant increase in knowledge as a result of the training, and some evidence to support a shift in attitudes in the desirable direction relating to the need to speak-up to seniors. No effect of the training was found on behavior. The results are encouraging in terms of reactions and learning, but further training is required to impact the behavior of junior doctors.