Provision of the emergency contraceptive pill without prescription : attitudes and practices of pharmacists in Australia

Background : As 5 years have elapsed since the emergency contraceptive pill (ECP) was made available without prescription in Australia, information was sought about the current attitudes and practices of pharmacists in relation to their increased role in ECP provision.

Study Design : A mail survey was implemented; questionnaires were distributed to 750 pharmacies across Australia during 2008-2009. Descriptive statistics were calculated and multiple logistic regression was used to examine factors associated with declining to dispense ECP.

Results : Response rate was 29%. Most pharmacists used a protocol to guide ECP dispensing (77.3%) and the majority had declined ECP provision (75.1%) in certain circumstances. Many usually counselled where confidentiality could be assured (62.8%), and agreed that it is a pharmacist's role to counsel on regular contraception (81.9%). Factors significantly associated (p≤.05) with dispensing practices included pharmacists' attitudes towards acceptability of advance prescription, their age, gender and pharmacy accessibility.

Conclusions : New information about Australian pharmacists' current attitudes and practices towards ECP dispensing was identified. Pharmacists had stronger, more conservative attitudes than overseas pharmacists; however, the issues that emerged were similar to those reported overseas. To address these, revised training for local pharmacists is recommended.

Assessing cost-effectiveness in obesity : active transport program for primary school children— TravelSMART schools curriculum program

Background: To assess from a societal perspective the cost-effectiveness of a school program to increase active transport in 10- to 11-year-old Australian children as an obesity prevention measure.
Methods: The TravelSMART Schools Curriculum program was modeled nationally for 2001 in terms of its impact on Body Mass Index (BMI) and Disability-Adjusted Life Years (DALYs) measured against current practice. Cost offsets and DALY benefits were modeled until the eligible cohort reached age 100 or died. The intervention was qualitatively assessed against second stage filter criteria (‘equity,’ ‘strength of evidence,’ ‘acceptability to stakeholders,’ ‘feasibility of implementation,’ ‘sustainability,’ and ‘side-effects’) given their potential impact on funding decisions.
Results: The modeled intervention reached 267,700 children and cost $AUD13.3M (95% uncertainty interval [UI] $6.9M; $22.8M) per year. It resulted in an incremental saving of 890 (95%UI –540; 2,900) BMI units, which translated to 95 (95% UI –40; 230) DALYs and a net cost per DALY saved of $AUD117,000 (95% UI dominated; $1.06M).
Conclusions: The intervention was not cost-effective as an obesity prevention measure under base-run modeling assumptions. The attribution of some costs to nonobesity objectives would be justified given the program’s multiple benefits. Cost-effectiveness would be further improved by considering the wider school community impacts.

Psychometric properties of a scale to measure investment in the sick role : the Illness Cognitions Scale

Rationale, aims and objectives A person’s beliefs about their illness may contribute to recovery and prognosis. Some degree of acceptance of illness and its impact is necessary to integrate the presence of a chronic disorder into one’s lifestyle and adhere to necessary components of illness management; however, some individuals can become ‘stuck’ and have difficulty adjusting out of the sick role. Inventories exist to measure illness cognitions, attitudes and behaviours as they relate to hypochondria and psychosomatic illness, but there is no extant measure of sick role inertia.We describe the psychometric properties of a new scale, the Illness Cognitions Scale (ICS), a metric of investment in the sick role.

Methods The ICS was administered to 97 individuals with bipolar or schizoaffective disorder, and the psychometric properties of the scale measured. Dimensionality was assessed using Principal Components Analysis with Oblimin rotation.

Results The scale has a strong internal consistency, with a Cronbach’s alpha of 0.858. Results of a factor analysis suggested the presence of one main factor, with three other smaller, related sub-factors, capturing aspects of maladaptive illness beliefs.

Conclusion The ICS is a 17-item, internally validated scale measuring difficulty adjusting out of the sick role. The scale predominantly measures a single construct. Further research on external validity of the ICS is required as well as determination of the clinical significance and patient acceptability of the scale.

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.

Methodological challenges to research among Chinese : using mixed methods to investigate older persons with depression in Macau

The article offers an example of using a mixed methods design that was implemented when investigating depression among Chinese older persons in Macau. A challenge in designing the study was that in light of literature on Chinese culture and somatization theory, the acceptability of the methodology was uncertain. Participants (n = 31) were purposively selected and quantitative data were collected using multiple standardized measures. Questions raised by the quantitative approach were then reflected through in-depth interviews. Four dominant categories emerged: (a) negative thinking, (b) physical limitations and complaints, (c) present living conditions and social support, and (d) the lives participants have lived. There was a high level of congruence between quantitative scores and narratives. The research approach was acceptable to the participants, and the findings contributed to an understanding of depression and therapeutic interventions for that population within Chinese culture.

A pilot study of a telephone-based parental intervention to increase fruit and vegetable consumption in 3-5 year old children

Objective : To examine the potential efficacy of a brief telephone-based parental intervention in increasing fruit and vegetable consumption in children aged 3–5 years and to examine the feasibility of intervention delivery and acceptability to parents.

Design : A pre–post study design with no comparison group. Telephone surveys were conducted approximately 1 week before and following intervention delivery.
Setting Participants were recruited through pre-schools in the Hunter region, New South Wales, Australia.

Subjects : Thirty-four parents of 3–5-year-olds received four 30-min interventional telephone calls over 4 weeks administered by trained telephone interviewers. The scripted support calls focused on fruit and vegetable availability and accessibility within the home, parental role modelling of fruit and vegetable consumption and on implementing supportive family eating routines.

Results : Following the intervention, the frequency and variety of fruit and vegetable consumption increased (P = 0·027), as measured by a subscale of the children's dietary questionnaire. The intervention was feasible to be delivered to parents, as all participants who started the intervention completed all four calls, and all aspects of the interventional calls, including the number, length, content, format and relevance, were considered acceptable by more than 90 % of parents.

Conclusions : A brief telephone-based parental intervention to encourage fruit and vegetable consumption in pre-school-aged children may be effective, feasible and acceptable. Further investigation is warranted in a randomised controlled trial.

Promoting Fundamental movement skill development and physical activity in early childhood settings : a cluster randomized controlled trial

The aim of this study was to assess the feasibility, acceptability and potential efficacy of a physical activity program for preschool children. A 20-week, 2-arm parallel cluster randomized controlled pilot trial was conducted. The intervention comprised structured activities for children and professional development for staff. The control group participated in usual care activities, which included designated inside and outside playtime. Primary outcomes were movement skill development and objectively measured physical activity. At follow-up, compared with children in the control group, children in the intervention group showed greater improvements in movement skill proficiency, with this improvement statically significant for overall movement skill development (adjust diff. = 2.08, 95% CI 0.76, 3.40; Cohen’s d = 0.47) and significantly greater increases in objectively measured physical activity (counts per minute) during the preschool day (adjust diff. = 110.5, 95% CI 33.6, 187.3; Cohen’s d = 0.46). This study demonstrates that a physical activity program implemented by staff within a preschool setting is feasible, acceptable and potentially efficacious.

Building the capacity of family day care educators to promote children’s social and emotional wellbeing : an exploratory cluster randomised controlled trial

Background: Childhood mental health problems are highly prevalent, experienced by one in five children living in socioeconomically disadvantaged families. Although childcare settings, including family day care are ideal to promote children’s social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children’s mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of “Thrive,” an intervention program to build the capacity of family day care educators to promote children’s social and emotional wellbeing. Thrive aims to increase educators’ knowledge, confidence and skills in promoting children’s social and emotional wellbeing.
Methods/Design: This study involves one family day care organisation based in a low socioeconomic area of Melbourne. All family day care educators (term used for registered carers who provide care for children for financial reimbursement in the carers own home) are eligible to participate in the study. The clusters for randomisation will be the fieldworkers (n = 5) who each supervise 10-15 educators. The intervention group (field workers and educators) will participate in a variety of intervention activities over 12 months, including workshops; activity exchanges with other educators; and focused discussion about children’s social and emotional wellbeing during field worker visits. The control group will continue with their normal work practice. The intervention will be delivered to the intervention group and then to the control group after a time delay of 15 months post intervention commencement. A baseline survey will be conducted with all consenting educators and field workers (n = ~70) assessing outcomes at the cluster and individual level. The survey will also be administered at one month, six months and 12 months post-intervention commencement. The survey consists of questions measuring perceived levels of knowledge, confidence and skills in promoting children’s social and emotional wellbeing. As much of this intervention will be delivered by field workers, field worker-family day care educator relationships are key to its success and thus supervisor support will also be measured. All educators will also have an in-home quality of care assessment at baseline, one month, six months and 12 months post-intervention commencement. Process evaluation will occur at one month, six months and 12 months post-intervention commencement. Information regarding intervention fidelity and economics will also be assessed in the survey.
Discussion: A capacity building intervention in child mental health promotion for family day care is an essential contribution to research, policy and practice. This initiative is the first internationally, and essential in building an evidence base of interventions in this extremely policy-timely setting.

The population cost-effectiveness of interventions designed to prevent childhood depression

BACKGROUND AND OBJECTIVES: Depression in childhood and adolescence is common and often persists into adulthood. This study assessed the population-level cost-effectiveness of a preventive intervention that screens children and adolescents for symptoms of depression in schools and the subsequent provision of a psychological intervention to those showing elevated signs of depression. The target population for screening comprised 11- to 17-year-old children and adolescents in the 2003 Australian population.

METHODS: Economic modeling techniques were used to assess the incremental cost-effectiveness of the intervention compared with no intervention. The perspective was that of the health sector, and outcomes were measured by using disability-adjusted life-years (DALYs). Multivariate probabilistic and univariate sensitivity testing was applied to quantify variations in the model parameters.

RESULTS: The modeled psychological intervention had an incremental cost-effectiveness ratio of $5400 per DALY averted, with just 2% of iterations falling above a $50 000 per DALY value-for-money threshold. Results were robust to model assumptions.

CONCLUSIONS: After school screening, screening and the psychological intervention represent good value-for-money. Such an intervention needs to be seriously considered in any national package of preventive health services. Acceptability issues, particularly to intervention providers, including schools and mental health professionals, need to be considered before wide-scale adoption.

The national bowel cancer screening program

The Australian Bowel Cancer Screening Pilot Program was conducted in Mackay, Melbourne and Adelaide during 2003 and 2004. The primary aim was to provide information about the feasibility, acceptability and cost effectiveness of bowel cancer screening amongst the Australian population in both rural and urban areas. This presentation will present key results from the analysis of the pilot monitoring data and describe some implications of these results for the National Bowel Screening Program’s design.

Patient-reported outcomes in trials of incretin-based therapies in patients with type 2 diabetes mellitus

Incretin-based therapies have a glucose-dependent mode of action that results in excellent glucose-lowering efficacy with very low risk of hypoglycaemia, and weight neutrality [dipeptidyl peptidase-4 (DPP-4) inhibitors] or weight loss [glucagon-like peptide-1 (GLP-1) receptor agonists], in people with type 2 diabetes mellitus (T2DM). Patient-reported outcomes (PROs) complement physician evaluations of efficacy and tolerability and offer insights into the subjective experience of using modern diabetes treatments. We conducted a systematic search of clinical trials of the GLP-1 receptor agonists liraglutide, exenatide and long-acting exenatide, one of which included the oral DPP-4 inhibitor sitagliptin as a comparator. No other PRO data for DPP-4 inhibitors were identified. This review summarizes PRO data from eight clinical trials, the majority of which used the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and/or Impact of Weight on Quality of Life-Lite (IWQOL-Lite) to evaluate patient experience. People with T2DM were highly satisfied with modern incretin-based therapies compared with traditional therapies. Treatment satisfaction (including perceptions of convenience and flexibility) was high and generally higher with GLP-1 agonists in association with their greater glucose-lowering efficacy and tendency to facilitate weight loss. Weight-related quality of life (QoL) also improved in people using incretin therapies. The glycaemic improvements achieved with GLP-1 receptor agonists, coupled with the low incidence of hypoglycaemia and ability to cause weight loss, seemed to offset potential concern about injections. It is plausible that superior patient-reported benefits found in clinical trials may translate into improved, clinically meaningful, long-term outcomes through increased treatment acceptability. Long-term, prospective data are needed to ascertain whether this is the case in practice.

Does self monitoring of blood blucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

Background
The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.

Methods/Design
The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.

The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.

Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.

Discussion
The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study.

A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression (‘MoodCare’): study protocol

Background Coronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI) and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL), decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare) for depression and CHD secondary prevention, with Usual Care (UC).

Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group). The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake), medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1), 6 months (post-intervention) (Time 2), 12 months (Time 3) and 24 months follow-up for longer term effects (Time 4). We are comparing depression (Cardiac Depression Scale [CDS]) and HRQOL (Short Form-12 [SF-12]) scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.

Discussion This manuscript presents the protocol for a randomised, multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients. The results of this trial will provide valuable new information about potential psychological and wellbeing benefits, cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression.

Decision support and the effectiveness of web-based delivery and information tailoring for bowel cancer screening : an exploratory study

Background: Colorectal cancer (CRC) is the third most commonly diagnosed cancer in males and the second in females throughout the developed world. Population screening using fecal occult blood tests (FOBTs) facilitates early detection and greater chance of survival, but participation rates are low. We developed a Web-based decision tool to provide information tailored to an individual’s decision stage for CRC screening and attitude toward screening utilizing the Preventive Health Model (PHM) and Precaution Adoption Process Model (PAPM) as theoretical frameworks for screening behavior. We describe the practical steps employed in the tool’s design and the subsequent conduct of an exploratory study.
Objective: To design a decision tool for CRC screening and conduct an exploratory study among average-risk men and women to (1) test the impact of message type (tailored vs non-tailored) and message delivery modality (Web-based vs paper-based) on attitudes toward screening and screening uptake, and (2) investigate the acceptability of the decision tool and relevance of materials.
Methods: Participants (n = 100), recruited from a population sample of men and women aged 50-76 residing in urban Adelaide, Australia, were randomly assigned to a control group or one of 4 interventions: (1) Web-based and tailored information, (2) paper-based and tailored information, (3) Web-based and non-tailored (generic) information, or (4) paper-based and non-tailored information. Participation was augmented by snowball recruitment (n = 19). Questionnaires based on PHM variables were administered pre- and post-intervention. Participants were given the opportunity to request an FOBT. Following the intervention, participants discussed the acceptability of the tool.
Results: Full data were available for 87.4% (104/119) of participants. Post-intervention, perceived susceptibility scores for individuals receiving tailored information increased from mean 10.6 (SD 2.1) to mean 11.8 (SD 2.2). Scores on self-efficacy increased in the tailored group from mean 11.7 (SD 2.0) to mean 12.6 (SD 1.8). There were significant time x modality x message effects for social influence and salience and coherence, reflecting an increase in these scores for tailored Web-based participants only; social influence scores increased from mean 11.7 (SD 2.6) to mean 14.9 (SD 2.3), and salience and coherence scores increased from mean 16.0 (SD 2.2) to mean 17.7 (SD 2.1). There was no greater influence of modality or message type on movement toward a decision to screen or screening uptake, indicating that neither tailored messages nor a Web modality had superior effect. Overall, participants regarded tailored messages positively, but thought that the Web tool lacked “media richness.”
Conclusions: This exploratory study confirms that tailoring on PHM predictors of CRC screening has the potential to positively address attitudes toward screening. However, tailoring on these variables did not result in significantly increased screening uptake. Future research should consider other possible psychosocial influences. Mode of delivery did not affect outcomes, but as a delivery medium, the Web has economic and logistical advantages over paper.

Assessing the impact of diabetes on the quality of life of older adults living in a care home : validation of the ADDQoL senior

Aims  Around a quarter of UK care-home residents have diabetes. Diabetes is known to impact quality of life but existing diabetes-specific quality of life measures are unsuitable for elderly care-home residents. We aimed to develop and evaluate a new measure for use with older adults, to be particularly suitable for use with care-home residents: the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Senior†.

Methods  Content and format changes were made to the 19-domain ADDQoL, informed by related measures for people with visual impairments (12 domain-specific items were retained, four items were revised/added and three items were removed). This revision was modified further following cognitive debriefing interviews with three older adults living in a care home. Psychometric evaluation of the newly developed 17-domain ADDQoL Senior was conducted using data from 90 care-home residents with diabetes who took part in a broader intervention study.

Results  The life domains most impacted by diabetes were ‘independence’ and ‘freedom to eat as I wish’. The ADDQoL Senior demonstrated good factor structure and internal consistency (Cronbach’s alpha = 0.924). Domain scores were, as expected, significantly intercorrelated.

Conclusions  The ADDQoL Senior measures the perceived impact of diabetes on quality of life in older adults, and has been found to be suitable for those living in care homes if administered by interview. The scale has demonstrated acceptability and excellent psychometric properties. It is anticipated that the number of items may be reduced in the future if our current findings can be replicated.