The impact of hypoglycaemia on quality of life and related patient-reported outcomes in Type 2 diabetes : a narrative review

As a common side effect of insulin treatment for diabetes, hypoglycaemia is a constant threat and can have far-reaching and potentially devastating consequences, including immediate physical injury as well as more pervasive cognitive, behavioural and emotional effects. Moreover, as a significant limiting factor in achieving optimal glycaemic control, exposure to hypoglycaemia can influence diabetes self-management.

Although hypoglycaemia is known to occur in Type 2 diabetes, its morbidity and impact on the individual are not well recognized. The aim of the current review is to examine published evidence to achieve a synthesis of the scope and significance of the potential detriment caused by hypoglycaemia to individuals with Type 2 diabetes. The implications of these observations for treatment and research have also been considered.

A narrative review was performed of empirical papers published in English since 1966, reporting the effect of hypoglycaemia on quality of life and related outcomes (including generic and diabetes specificquality of life, emotional well-being and health utilities) in Type 2 diabetes.

Research demonstrates the potential impact of hypoglycaemia on the lives of people with Type 2 diabetes, from an association with depressive symptoms and heightened anxiety, to impairment of the ability to drive, work and function in ways that are important for quality of life. Few studies consider hypoglycaemia as an explanatory variable in combination with quality of life or related primary endpoints. As a consequence, there is a pressing need for high-quality research into the overall impact of hypoglycaemia on the lives of people with Type 2 diabetes.

Predicting outcomes in the Dose Adjustment For Normal Eating (DAFNE) trial

Background: In the UK, DAFNE training in flexible intensive insulin therapy significantly reduced the negative impact of diabetes on quality of life (QoL) and improved blood glucose (BG) control without significantly increasing severe hypoglycaemia or body mass index (BMI). Analyses were conducted to predict who would benefit most from the generally highly successful DAFNE training and who might experience undesirable effects (e.g. weight gain).

Methods: Multiple regression was used to predict change in outcomes (6-months post-DAFNE) using baseline data: demographic, biomedical, ADDQoL (measure of the impact of diabetes on QoL), extended DTSQ (Diabetes Treatment Satisfaction Questionnaire), and other psychological measures including diabetes-specific well-being and locus of control.

Findings: Greatest improvement in ADDQoL scores was achieved by those reporting less dietary freedom and less treatment satisfaction at baseline (R2=0.21). BG improvement was predicted by higher baseline BG, lower perceived frequency of hypoglycaemia, greater expectations of DAFNE, and greater BMI (R2=0.30). Increase in BMI was predicted by less dietary freedom, DAFNE training centre, and less ‘satisfaction with insulin’ at baseline (R2=0.23).

Conclusions/Discussion: DAFNE has important benefits to offer. Lifting dietary restrictions had substantial benefits for QoL. BG improvement was predicted by baseline BG but also by expectations (perhaps reflecting greater optimism or determination). Prediction of weight gain was more complex. The influence of training centre will have involved implicit messages conveyed by Educators before and during DAFNE. While DAFNE was successful overall, outcomes are likely to be maximised for individuals if their expectations and personal goals are considered by DAFNE Educators.

Health beliefs - what role do they play in outcomes research?

Lay beliefs about health and illness are individual and social, influenced by prevailing social and medical ideologies. Health beliefs clearly influence self-care motivation and have an effect on health-promoting behaviour (e.g. attendance at a screening program, food choices, adherence to prescribed medication). Further, the beliefs and attributions that people hold can directly affect physiological systems (e.g. the immune system). Health beliefs have been shown to influence a variety of patient-reported outcomes, including medication adherence, satisfaction and health-related quality of life. It is widely acknowledged that when the patient's beliefs are acknowledged and incorporated, rather than ignored, optimal biomedical patient-reported outcomes are more likely to be achieved. Several psychological models have been developed to predict health behaviours and may be utilised to identify the beliefs that inform such behaviours. These models consider the social milieu, personality, demographic, political and economic predictors of health beliefs. They demonstrate the impact of beliefs such as the causes of illness, effectiveness of healthcare and acceptability of health services, and how manipulating these can result in actual or intended behaviour change. This workshop will introduce health beliefs and discuss the psychological models that underpin the translation of belief into behaviour. The session is interactive, with participants defining health beliefs and their impact on behaviour. Participants will be invited to critique the models and apply their chosen model to a health indication of their choice.

Missing Data - implications for outcomes research and strategies to maximise data integrity

he workshop will firstly provide an overview of the problems associated with missing data within the context of clinical trials and how to minimise these. Missing data will be explored by modeling the impact on a number of datasets. This approach will be invaluable in highlighting how alternative methods for controlling for missing data impact differentially on the interpretation of study findings. Popular strategies involve options based on an assessment of the percentage of missing data. More innovative approaches to the management of missing data (e.g. based upon reliability analyses) will be explored and evaluated and the role of the most popular methods of data management explored in several study designs beyond those of the classic randomised controlled trial. Participants will have the opportunity to appraise and debate existing methods of missing data handling.

The effects of perceived business uncertainty, external consultants and risk management on organisational outcomes

Purpose – The purpose of this paper is to investigate the relations between perceived business uncertainty (PBU), use of external risk management (RM) consultants, formalisation of RM, magnitude of RM methods and perceived organisational outcomes.
Design/methodology/approach – This paper is based on a questionnaire survey of members of the Chartered Institute of Management Accountants in the UK. Using AMOS 17.0, the paper tests the strength of the direct and indirect effects among the variables and explores the fit of the overall path model.
Findings – The results indicate significant and positive associations exist between the extent of PBU and the level ofRMformalisation, as well as between the level ofRMformalisation and the magnitude of RMmethods adopted. The use of externalRMconsultants is also found to have a significant and positive impact on the magnitude of RM methods adopted. Finally, both the extent of RM formalisation and the magnitude of RM methods adopted are seen to be significantly associated with overall improvement in organisational outcomes.
Research limitations/implications – The study uses perceptual measures of the level of business uncertainty, usage of RM and organisational outcomes. Further, the respondents are members of a management accounting professional body and the views of other managers, such as risk managers, who are also important to the governance process are not incorporated.
Originality/value – This study provides empirical evidence on the impact ofRMdesign and usage on improvements in organisational outcomes. It contributes to the RM literature where empirical research is needed in order to be comparable with the traditional management control system literature.

Splash!: a prospective birth cohort study of the impact of environmental, social and family-level influences on child oral health and obesity related risk factors and outcomes

Background: Dental caries (decay) is the most prevalent disease of childhood. It is often left untreated and can impact negatively on general health, and physical, developmental, social and learning outcomes. Similar to other health issues, the greatest burden of dental caries is seen in those of low socio-economic position. In addition, a number of diet-related risk factors for dental caries are shared risk factors for the development of childhood obesity. These include high and frequent consumption of refined carbohydrates (predominately sugars), and soft drinks and other sweetened beverages, and low intake of (fluoridated) water. The prevalence of childhood obesity is also at a concerning level in most countries and there is an opportunity to determine interventions for addressing both of these largely preventable conditions through sustainable and equitable solutions. This study aims to prospectively examine the impact of drink choices on child obesity risk and oral health status.
Methods/Design: This is a two-stage study using a mixed methods research approach. The first stage involves qualitative interviews of a sub-sample of recruited parents to develop an understanding of the processes involved in drink choice, and inform the development of the Discrete Choice Experiment analysis and the measurement instruments to be used in the second stage. The second stage involves the establishment of a prospective birth cohort of 500 children from disadvantaged communities in rural and regional Victoria, Australia (with and without water fluoridation). This longitudinal design allows measurement of changes in the child’s diet over time, exposure to fluoride sources including water, dental caries progression, and the risk of childhood obesity.
Discussion: This research will provide a unique contribution to integrated health, education and social policy and program directions, by providing clearer policy relevant evidence on strategies to counter social and environmental factors which predispose infants and children to poor health, wellbeing and social outcomes; and evidence-based strategies to promote health and prevent disease through the adoption of healthier lifestyles and diet. Further, given the absence of evidence on the processes and effectiveness of contemporary policy implementation, such as community water fluoridation in rural and regional communities it’s approach and findings will be extremely
informative.

Obstacles in the optimization of bone health outcomes in the female athlete triad

Maintaining low body weight for the sake of performance and aesthetic purposes is a common feature among young girls and women who exercise on a regular basis, including elite, college and high-school athletes, members of fitness centres, and recreational exercisers. High energy expenditure without adequate compensation in energy intake leads to an energy deficiency, which may ultimately affect reproductive function and bone health. The combination of low energy availability, menstrual disturbances and low bone mineral density is referred to as the ‘female athlete triad’. Not all athletes seek medical assistance in response to the absence of menstruation for 3 or more months as some believe that long-term amenorrhoea is not harmful. Indeed, many women may not seek medical attention until they sustain a stress fracture.
This review investigates current issues, controversies and strategies in the clinical management of bone health concerns related to the female athlete triad. Current recommendations focus on either increasing energy intake or decreasing energy expenditure, as this approach remains the most efficient strategy to prevent further bone health complications. However, convincing the athlete to increase energy availability can be extremely challenging.
Oral contraceptive therapy seems to be a common strategy chosen by many physicians to address bone health issues in young women with amenorrhoea, although there is little evidence that this strategy improves bone mineral density in this population. Assessment of bone health itself is difficult due to the limitations of dual-energy X-ray absorptiometry (DXA) to estimate bone strength. Understanding how bone strength is affected by low energy availability, weight gain and resumption of menses requires further investigations using 3-dimensional bone imaging techniques in order to improve the clinical management of the female athlete triad.