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.

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.

Changing clinical practice can improve clinical outcomes for women with pre-gestational diabetes mellitus.

Prospective evaluation of pregnancy outcomes in women with pre-gestational diabetes over 6 years. The ATLANTIC Diabetes in Pregnancy group represents 5 antenatal centres along the Irish Atlantic seaboard, providing care for women with diabetes throughout pregnancy. In 2007 the group published a report that recognised that women were poorly prepared for pregnancy and that outcomes were sub-optimal. A change in practice occurred, offering women specialist-led, evidence-based care, both pre-pregnancy and combined antenatal/diabetes clinics during pregnancy. We now compare outcomes from 2005-2007 with 2008-2010. There was an increase in the numbers attending pre-conception care. Glycemic control before and throughout pregnancy improved. There was an overall increase in live births and decrease in perinata mortality rate. There was a decrease in large-for-gestational-age babies in mothers with Type 1 Diabetes. Elective Caesarean section rates increased while emergency section rates decreased. More women had Type 2 diabetes over time and these women were more likely to be obese. Changing the process of clinical care delivery can improve outcomes in for women with pre-gestational diabetes.

A regional pre-pregnancy care (PPC) programme for women with type 1 and type 2 diabetes.

Unfortunately the risks associated with pregnancy in a woman with Diabetes (Type 1 and Type 2) continue to be high. However these risks can be reduced significantly with pregnancy planning and pre-pregnancy care. We report here the establishment of a regional pre pregnancy service and the interim results of its benefits. Pre pregnancy care is as vital as combined diabetes antenatal care for women with diabetes and must become the norm for this population.

Early gestational diabetes mellitus (GDM) is associated with worse pregnancy outcomes compared with GDM diagnosed at 24-28 weeks gestation despite early treatment.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated+ with adverse pregnancy outcomes compared with women with normal glucose tolerance in pregnancy. The WHO recommends screening at 24-28 weeks gestation for GDM. Women who are diagnosed before 24-28 weeks gestation have a longer intervention period which may impact positively on pregnancy outcomes. AIM: This study aimed to examine pregnancy outcomes of women with GDM diagnosed <24 weeks gestation compared with those diagnosed at 24-28 weeks in a large Irish cohort. METHODS: A retrospective cohort study of 1471 pregnancies in women with GDM diagnosed using IADPSG criteria between September 2012 and April 2016 was conducted. At GDM diagnosis, women were classified as early GDM <24 weeks or standard GDM 24-28 weeks gestation. RESULTS: Women with early GDM had a significantly greater risk of pregnancy-induced hypertension (12.4% vs. 5.3%; P < 0.05), post-partum haemorrhage (8.7% vs. 2.4%; P < 0.05) and post-partum glucose abnormalities (32% vs. 15.6%; P < 0.05). Their offspring had a greater risk of pre-maturity (10.9% vs. 6.6%; P < 0.05), stillbirth (1.4% vs. 0.5%; P < 0.05), large for gestational age (19.1% vs. 13.4% P < 0.05) and need neonatal intensive care (30.7% vs. 22.1%; P < 0.05) compared with offspring of women with standard GDM. Rates of C-section and pre-maturity were still higher in the early GDM group when the two groups where compared based on their post-natal OGTT. CONCLUSION: Early GDM women and their offspring are at greater risk of an adverse pregnancy outcome compared with those diagnosed at 24-28 weeks. In view of the abnormal post-natal glucose findings, early GDM may reflect a more advanced state in diabetes pathogenesis.

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.

Treatment of angina pectoris: associations with symptom severity.

OBJECTIVE: To evaluate whether the frequency of anginal attacks in medically treated patients with stable angina is related to the intensity of anti-anginal treatment, the clinical history and coronary anatomy. METHODS: Analysis of baseline data from the A Coronary disease Trial Investigating Outcome with Nifedipine GITS (ACTION) study, an ongoing placebo-controlled trial in 7669 patients with stable angina pectoris who require anti-anginal treatment. RESULTS: Prior to randomisation, 8% of 7669 patients had no anginal attacks, 63% had occasional, 22% had regular, 4% had frequent and 3% had daily attacks. Men (79% of all patients) and patients with a history of MI (51%) had less frequent anginal attacks (P<0.0001). The number of coronary angiograms ever performed (70% had at least one angiogram), the extent of angiographic coronary disease (32% of those who had angiography had more than two-vessel disease), a history of peripheral artery disease (12%), the number of anti-anginal drugs used (64% were prescribed two or more such medications) and a history of revascularisation (a history of coronary bypass surgery was present in 23% and of balloon dilatation in 26%) were each positively associated with anginal attack frequency. CONCLUSIONS: For the majority of patients with chronic stable angina not on a calcium-antagonist, medical treatment with other anti-anginal drugs is sufficient to control symptoms and only a minority of patients are refractory to medical treatment. Invasive treatments for chronic stable angina are only needed in a small proportion where symptoms persist.

Human reliability analysis of an offshore emergency blowdown system.

An offshore platform depressurisation (blowdown) system was designed such that control in emergencies necessitated operator actions over a short space of time. The system design for these operations was analysed using a simple and pragmatic human reliability approach, embedded within a comprehensive risk assessment. The human reliability analysis identified several ways in which human actions could lead to system failure (flare overload), and in the total risk analysis these errors were found to dominate the risk picture. The causes of the human error related primarily to the design of the interface and co-ordination/communication problems previously unaddressed by the design process. Recommendations were made to reduce error potential based on the causes and mechanisms of error identified in the analysis, and several of these recommendations were included in the final design of the system.

Soft systems, hard lessons.

This paper is concerned with practical experiences of achieving human factors and safety interventions in the nuclear power and process control industries. It rests upon the premise that, although human factors (HF) and safety may be technological in approach, they nevertheless must operate in a socio-technical environment, within companies with corporate structures and cultures, interacting with regulatory authorities. A crucial ingredient to the successful implementation and integration of human factors into company practices and procedures is therefore the nature of the inter-relationships between human factors personnel and those who control the existing procedures determining all aspects of the design and operational processes. Such inter-relationships can largely determine whether HF is implemented or not. These human-human interactions and interfaces in a socio-technical system may be referred to as soft systems. When training in human factors, much of the training is concerned with technical aspects of the discipline. However, when entering industry or consultancy, one quickly discovers that technical aspects are usually the least of one's problems. This paper is concerned with experiences and guidance to better help the human factors professional starting out in industry. There is little scientific method in the paper. It is, instead, a distillation of this author's and others' experiences in acting either as a practitioner or consultant, or as leader of a human factors unit in industries that have at times been reluctant or even hostile about the perceived 'invasion' of human factors. However, to avoid being purely anecdotal, the experiences are placed in a framework concerned with the life cycle of integrating human factors into an industry, from being the first HF person in a company, to the development of a successful unit, or the absorption of a successful unit into other departments. Within this framework a range of strategic aspects are dealt with, such as integration of HF into the design process, and selection of test-case projects.

The validation of three human reliability quantification techniques--THERP, HEART and JHEDI: Part III--Practical aspects of the usage of the techniques.

This is the third paper in a series of three dealing with the detailed investigation of the empirical validity of three human reliability assessment (HRA) techniques. The first paper introduced the need for validation and specified the three techniques most requiring validation. The second paper detailed the results of an extensive independent validation experiment. This experimental validation involved 30 UK assessors using the techniques THERP, HEART and JHEDI (10 assessors per technique) to estimate the human error probabilities (HEPs) for 30 nuclear power and reprocessing (NP&R) tasks. The results for all three techniques were positive in terms of significant correlations, and general precision levels of 72% of all HEP estimates within a factor of 10 of the true value (unknown to the assessors). These results lend support to the empirical validity of these techniques in particular, and to HRA in general. However, the results were not all positive. In particular the consistency of usage of the techniques was variable. Additionally, subjects were generally not good at knowing their own uncertainty, i.e. they were not able to accurately predict when they were accurate nor when they were inaccurate. This desirable parameter is known as calibration, and the results from the validation suggested that subjects were not well-calibrated. This paper aims to determine how consistency of usage can be improved and to discern whether certain task types are, in practice, not well-assessed by the techniques, and hence are effectively currently beyond these techniques' abilities. Such information is aimed at aiding the HRA practitioner, or the ergonomist, interested in using these techniques. Recommendations for improving calibration are also discussed in this paper. A subsidiary but important focus of this paper is of a more fundamental nature, and of more general interest to the ergonomist. It concerns the validity of the techniques from an error reduction perspective. Currently these techniques may be used to identify how to reduce error probability, which is generally (in the qualitative sense) within the domain of ergonomics. One major mechanism for HRA-based error reduction is the utilisation of Performance Shaping Factor (PSF) information. This paper considers the validity of these PSF as ergonomics constructs. Drawing results from the validation exercise, it is seen how different PSF can be applied to the same scenario and can result in the same error probability, but will result in different error reduction guidance. It is therefore recommended that error reduction guidance must be based on a composite analysis of the results of the task, error identification and quantification analyses, with most weighting given to the qualitative analyses.

Human error identification in human reliability assessment. Part 1: Overview of approaches.

This paper reviews a number of approaches which can be used to identify human errors in human-machine systems. These approaches range from simple error classifications to sophisticated software packages based on models of human performance. However, the prediction of human behaviour in complex environments is far from being an easy task itself, and there is significant scope for improvement in human error identification 'technology'. This first paper in a series of two reviews the available techniques of human error identification, highlighting their strengths and weaknesses. The second paper will review the validation of such approaches, and likely future trends in this area of human reliability assessment.

Human error identification in human reliability assessment. Part 2: Detailed comparison of techniques.

This is the second part of a two-part review of human error identification (HEI) approaches in human reliability assessment (HRA). Part 1 reviewed the probabilistic risk assessment (PRA) context in which HRA occurs, and then detailed 12 HEI techniques which have evolved in the field of HRA. Part 2 attempts to compare the way these techniques perform against a range of criteria relevant to HEI theoretical and empirical validity, and practical usefulness in applied HRA. It is hoped that these comparisons will help assessors in the selection of techniques for practical applications. The comparisons also point to research and development needs in the area of applied HEI.

The validation of three human reliability quantification techniques - THERP, HEART and JHEDI: part 1 - technique descriptions and validation issues.

This is the first of a set of three papers reviewing the validity of three Human Reliability Assessment (HRA) techniques used in the UK to predict human performance in high risk industries. The techniques are used to determine the risks inherent in such industries due to human error, and also the benefit in terms of risk reduction by having human operators in the system. These techniques culminate in a quantitative human error probability for each error or failure identified, predicting how often errors or failed performance will occur. The major question with such an approach is whether such probabilities are accurate. This key validation question is answered in the second paper, which reports the results of a large and independent validation experiment. Once a technique achieves some degree of predictive validity, the next question becomes whether such a technique can consistently produce valid and accurate results. This is called the reliability of the technique, and is dependent upon its consistency of usage by different assessors. Consistency can only be analysed by investigating the detailed usage of the techniques, and such an analysis is reported in the third paper in this series. The advantage of such an analysis is that it can also lead to specification of practical guidance for practitioners, and may lead to derivation of ways to improve the reliability and consistency of usage of specific HRA techniques. This first paper introduces the three techniques themselves, and reviews the major validation criteria and issues which should be considered when trying to determine if such techniques work.

Human error identification techniques for risk assessment of high risk systems--Part 1: Review and evaluation of techniques.

This is the first in a two-part series of papers dealing with the area of assessing human errors in high risk complex systems. This first paper outlines thirty-eight approaches of error identification, categorising them into types of error identification approach. The paper then reviews these techniques with respect to a broad range of criteria. Viable and non-viable techniques are identified. Trends and research needs are also noted. The second paper proposes a framework or tool-kit approach to Human Error Identification, and presents a prototype methodology to show what such a framework approach would look like in practice, for the nuclear power domain.

Human error identification techniques for risk assessment of high risk systems--part 2: towards a framework approach.

This is the second paper in a series of two, reviewing human error identification approaches for risk assessment of high risk socio-technical systems. The previous paper identified and reviewed thirty-eight techniques. One of the closing comments was that no single technique sufficed for all the practitioner's needs, and that a potential way forward was to utilise a number of techniques in a toolkit fashion, or to develop a new framework-based or toolkit-based approach. This paper therefore describes in detail a framework approach developed for the UK nuclear power and reprocessing industry, showing the practical implementation of such a system. It then considers some of the advantages and disadvantages of such framework approaches. The paper also discusses some of the relationships between error identification and Ergonomics.

A case study of a human reliability assessment for an existing nuclear power plant.

This paper concerns a Human Reliability Assessment (HRA) carried out over a period of two years as part of a Nuclear Power Plant Probabilistic Safety Assessment (PSA). The HRA involved all elements of the HRA process, from problem definition and task analysis, through error representation and quantification, to impact assessment, error reduction, quality assurance and documentation. The aim of this paper is to show the methodology of HRA as applied in a real PSA, highlighting various elements of the HRA, and how the HRA interfaced with the PSA. Comments are also given on practical aspects and impacts of the various approaches, and the usefulness of a hybrid HRA/PSA team approach.

The validation of three human reliability quantification techniques--THERP, HEART and JHEDI: Part II--Results of validation exercise.

This is the second of three papers dealing with the validation of three Human Reliability Assessment (HRA) techniques. The first paper introduced the need for validation, the techniques themselves and pertinent validation issues. This second paper details the results of the validation study carried out on the Human Reliability Quantification techniques THERP, HEART and JHEDI. The validation study used 30 real Human Error Probabilities (HEPs) and 30 active Human Reliability Assessment (HRA) assessors, 10 per technique. The results were that 23 of the assessors showed a significant correlation between their estimates and the real HEPs, supporting the predictive accuracy of the techniques. Overall precision showed 72% (60-87%) of all HEPs to be within a factor of 10 of the true HEPs, with 38% of all estimates being within a factor of three of the true values. Techniques also tended to be pessimistic rather than optimistic, when they were imprecise. These results lend support to the empirical validity of these three approaches.

Safety intelligence: an exploration of senior managers' characteristics.

Senior managers can have a strong influence on organisational safety. But little is known about which of their personal attributes support their impact on safety. In this paper, we introduce the concept of 'safety intelligence' as related to senior managers' ability to develop and enact safety policies and explore possible characteristics related to it in two studies. Study 1 (N = 76) involved direct reports to chief executive officers (CEOs) of European air traffic management (ATM) organisations, who completed a short questionnaire asking about characteristics and behaviours that are ideal for a CEO's influence on safety. Study 2 involved senior ATM managers (N = 9) in various positions in interviews concerning their day-to-day work on safety. Both studies indicated six attributes of senior managers as relevant for their safety intelligence, particularly, social competence and safety knowledge, followed by motivation, problem-solving, personality and interpersonal leadership skills. These results have recently been applied in guidance for safety management practices in a White Paper published by EUROCONTROL.

ATLANTIC DIP: simplifying the follow-up of women with previous gestational diabetes.

OBJECTIVE: Previous gestational diabetes (GDM) is associated with a significant lifetime risk of type 2 diabetes. In this study, we assessed the performance of HbA1c and fasting plasma glucose (FPG) measurements against that of 75 g oral glucose tolerance testing (OGTT) for the follow-up screening of women with previous GDM. METHODS: Two hundred and sixty-six women with previous GDM underwent the follow-up testing (mean of 2.6 years (s.d. 1.0) post-index pregnancy) using HbA1c (100%), and 75 g OGTT (89%) or FPG (11%). American Diabetes Association (ADA) criteria for abnormal glucose tolerance were used. DESIGN, COHORT STUDY, AND RESULTS: The ADA HbA1c high-risk cut-off of 39 mmol/mol yielded sensitivity of 45% (95% CI 32, 59), specificity of 84% (95% CI 78, 88), negative predictive value (NPV) of 87% (95% CI 82, 91) and positive predictive value (PPV) of 39% (95% CI 27, 52) for detecting abnormal glucose tolerance. ADA high-risk criterion for FPG of 5.6 mmol/l showed sensitivity of 80% (95% CI 66, 89), specificity of 100% (95% CI 98, 100), NPV of 96% (95% CI 92, 98) and PPV of 100% (95% CI 91, 100). Combining HbA1c ≥39 mmol/mol with FPG ≥5.6 mmol/l yielded sensitivity of 90% (95% CI 78, 96), specificity of 84% (95% CI 78, 88), NPV of 97% (95% CI 94, 99) and PPV of 56% (95% CI 45, 66). CONCLUSIONS: Combining test cut-offs of 5.6 mmol/l and HbA1c 39 mmol/mol identifies 90% of women with abnormal glucose tolerance post-GDM (mean 2.6 years (s.d.1.0) post-index pregnancy). Applying this follow-up strategy will reduce the number of OGTT tests required by 70%, will be more convenient for women and their practitioners, and is likely to lead to increased uptake of long-term retesting by these women whose risk for type 2 diabetes is substantially increased.

Left ventricular remodelling in post-myocardial infarction patients with left ventricular ejection fraction 40-50% vs 25-39%. Influence of nisoldipine treatment? An echocardiographic substudy from the DEFIANT II study.

OBJECTIVE: Left ventricular (LV) remodelling following acute myocardial infarction has generally been studied in patients with LV ejection fraction (EF) < 40%, and it has been shown that this process can be attenuated by ACE inhibitors. Little is known regarding LV remodelling in patients with LVEF > or = 40% or the effects of treatment in this patient cohort. The DEFIANT II study (Doppler Flow and Echocardiography in Functional cardiac insufficiency) included 542 post-infarction patients with LVEF 25-50% without overt heart failure within 13 days following acute myocardial infarction (AMI). They were then randomized to nisoldipine coat-core (CC) or placebo and followed up for 6 months. DESIGN: Two-dimensional echoes were obtained after 8 (5-13) days and 6 months following AMI. SETTING: LV end diastolic (ED) and end systolic (ES) volumes (V) were calculated in 503 patients with technically satisfactory paired echoes using the biplabe method of discs in a core laboratory. SUBJECTS: Group A. 217 patients with baseline EF 40-50%, of whom 112 were randomized to nisoldipine and 104 to placebo (one patient was taken off study medication). Group B. 286 patients with EF 25-39%, of whom 145 were randomized to nisoldipine and 141 to placebo. RESULTS: LVEDV was 175 (+/-45) ml in Group A vs 203 (+/-49) ml in Group B (p = 0.001) at baseline and 184 (+/-48) ml vs 213 (+/-56) ml (p = 0.001), respectively, at 6 months. LVESV at baseline was 97 (+/-42) ml in Group A vs 133 (+/-37) ml in Group B (p = 0.001), and 106 (+/-34) ml vs 134 (+/-45) ml (p = 0.001) at 6 months, respectively. The increase of LVESV was 9 (+/-29) ml in Group A vs 2 (+/-35) ml in Group B (p = 0.007). LVEF decreased by 2 (+/-6)% in Group A vs an increase of 3 (+/-6)% in Group B (p = 0.001). Treatment with nisoldipine had no influence on LV volumes in either of the two groups or in the total study group. CONCLUSION: LV dilatation 6 months following AMI in patients with EF 40-50% was similar in end diastole, but more pronounced in end systole vs patients with EF 25-39%. LV remodelling did not change significantly after nisoldipine treatment.