Sex-differences in reasons for non-participation at recruitment : Geelong Osteoporosis Study

Background : Understanding reasons for non-participation in health studies can help guide recruitment strategies and inform researchers about potential sources of bias in their study sample. Whilst there is a paucity of literature regarding this issue, it remains highly plausible that men and women may have varied reasons for declining an invitation to participate in research. We aimed to investigate sex-differences in the reasons for non-participation at baseline of the Geelong Osteoporosis Study (GOS).

Methods : The GOS, a prospective cohort study, randomly recruited men and women aged 20 years and over from a region in south-eastern Australia using Commonwealth electoral rolls (2001–06 and 1993–97, respectively). Reasons for non-participation (n=1,200) were documented during the two recruitment periods. We used the Pearson’s chi squared test to explore differences in the reasons for non-participation between men and women.

Results : Non-participation in the male cohort was greater than in the female cohort (32.9% vs. 22.9%; p<0.001). Overall, there were sex-differences in the reasons provided for non-participation (p<0.001); apparent differences related to time constraints (men 26.3% vs. women 10.4%), frailty/inability to cope with or understand the study (men 18.7% vs. women 30.6%), and reluctance over medical testing (men 1.1% vs women 9.9%). No sex-differences were observed for non-participation related to personal reason/disinterest, and language- or travel-related reasons.

Conclusions : Improving participation rates in epidemiological studies may require different recruitment strategies for men and women in order to address sex-specific concerns about participating in research.

Risk factors for recurrent Mycobacterium ulcerans disease after exclusive surgical treatment in an Australian cohort

Objective: To describe risk factors for recurrence after exclusive surgical treatment of Mycobacterium ulcerans infection. Design, setting and participants: Prospective observational cohort study of all M. ulcerans cases managed with surgery alone at Barwon Health, a tertiary referral hospital, from 1 January 1998 to 31 December 2011. A random-effects Poisson regression model was used to assess rates and associations of treatment failure. Main outcome measures: Rates of treatment failure and rate ratios (RRs) for factors associated with treatment failure. Results: Of 192 patients with M. ulcerans infection, 50 (26%) had exclusive surgical treatment. Median age was 65.0 years (interquartile range [IQR], 45.5-77.7 years), and median duration of symptoms was 46 days (IQR, 26-90 days). There were 20 recurrences in 16 patients. For first lesions, the recurrence incidence rate was 41.8 (95% CI, 25.6-68.2) per 100 person-years, and median time to recurrence was 50 days (IQR, 30-171 days). Recurrence occurred ≤ 3 cm from the original lesion in 13 cases, and >3 cm in nine. On univariable analysis, age ≥60 years (RR 13.84; 95% CI, 2.21-86.68; P< 0.01), distal lesions (RR, 20.43; 95% CI, 1.97-212.22; P<0.01), positive histological margins (RR, 21.02; 95% CI, 5.51-80.26; P< 0.001), immunosuppression (RR, 17.97; 95% CI, 4.17-77.47; P <0.01) and duration of symptoms >75 days (RR, 10.13; 95% CI, 1.76-58.23; P =0.02) were associated with treatment failure. On multivariable analysis, positive margins (RR, 7.72; 95% CI, 2.71-22.01; P<0.001) and immunosuppression (RR, 6.45; 95% CI, 2.42-17.20; P =0.01) remained associated with treatment failure. Conclusions: Recurrence rates after exclusive surgical treatment of M. ulcerans disease in an Australian cohort are high, with increased rates associated with immunosuppression or positive histological margins.

The association of cycling with all-cause, cardiovascular and cancer mortality: findings from the population-based EPIC-Norfolk cohort

Objectives
To investigate associations between modest levels of total and domain-specific (commuting, other utility, recreational) cycling and mortality from all causes, cardiovascular disease and cancer.

Design
Population-based cohort study (European Prospective Investigation into Cancer and Nutrition study-Norfolk).

Setting
Participants were recruited from general practices in the east of England and attended health examinations between 1993 and 1997 and again between 1998 and 2000. At the first health assessment, participants reported their average weekly duration of cycling for all purposes using a simple measure of physical activity. At the second health assessment, participants reported a more detailed breakdown of their weekly cycling behaviour using the EPAQ2 physical activity questionnaire.

Participants
Adults aged 40–79 years at the first health assessment.

Primary outcome measure
All participants were followed for mortality (all-cause, cardiovascular and cancer) until March 2011.

Results
There were 22 450 participants with complete data at the first health assessment, of whom 4398 died during follow-up; and 13 346 participants with complete data at the second health assessment, of whom 1670 died during follow-up. Preliminary analyses using exposure data from the first health assessment showed that cycling for at least 60 min/week in total was associated with a 9% reduced risk of all-cause mortality (adjusted HR 0.91, 95% CI 0.84 to 0.99). Using the more precise measures of cycling available from the second health assessment, all types of cycling were associated with greater total moderate-to-vigorous physical activity; however, there was little evidence of an association between overall or domain-specific cycling and mortality.

Conclusions
Cycling, in particular for utility purposes, was associated with greater moderate-to-vigorous and total physical activity. While this study provides tentative evidence that modest levels of cycling may reduce the risk of mortality, further research is required to confirm how much cycling is sufficient to induce health benefits.

Study protocol: the childhood to adolescence transition study (CATS)

Background
Puberty is a multifaceted developmental process that begins in late-childhood with a cascade of endocrine changes that ultimately lead to sexual maturation and reproductive capability. The transition through puberty is marked by an increased risk for the onset of a range of health problems, particularly those related to the control of behaviour and emotion. Early onset puberty is associated with a greater risk of cancers of the reproductive tract and cardiovascular disease. Previous studies have had methodological limitations and have tended to view puberty as a unitary process, with little distinction between adrenarche, gonadarche and linear growth. The Childhood to Adolescence Transition Study (CATS) aims to prospectively examine associations between the timing and stage of the different hormonally-mediated changes, as well as the onset and course of common health and behavioural problems that emerge in the transition from childhood to adolescence. The initial focus of CATS is on adrenarche, the first hormonal process in the pubertal cascade, which begins for most children at around 8 years of age.

Methods/Design
CATS is a longitudinal population-based cohort study. All Grade 3 students (8–9 years of age) from a stratified cluster sample of schools in Melbourne, Australia were invited to take part. In total, 1239 students and a parent/guardian were recruited to participate in the study. Measures are repeated annually and comprise student, parent and teacher questionnaires, and student anthropometric measurements. A saliva sample was collected from students at baseline and will be repeated at later waves, with the primary purpose of measuring hormonal indices of adrenarche and gonadarche.

Discussion
CATS is uniquely placed to capture biological and phenotypic indices of the pubertal process from its earliest manifestations, together with anthropometric measures and assessment of child health and development. The cohort will provide rich detail of the development, lifestyle, external circumstances and health of children during the transition from childhood through to adolescence. Baseline associations between the hormonal measures and measures of mental health and behaviour will initially be examined cross-sectionally, and then in later waves longitudinally. CATS will make a unique contribution to the understanding of adrenarche and puberty in children’s health and development.

Implementation of pressure ulcer prevention best practice recommendations in acute care: an observational study

Pressure ulcers are a common but preventable problem in hospitals. Implementation of best practice guideline recommendations can prevent ulcers from occurring. This 9-year cohort study reports prevalence data from point prevalence surveys during the observation period, and three practice metrics to assess implementation of best practice guideline recommendations: (i) nurse compliance with use of a validated pressure ulcer risk assessment and intervention checklist; (ii) accuracy of risk assessment scoring in usual-care nurses and experienced injury prevention nurses; and (iii) use of pressure ulcer prevention strategies. The prevalence of hospital-acquired pressure ulcers decreased following implementation of an evidence-based prevention programme from 12·6% (2 years preprogramme implementation) to 2·6% (6 years postprogramme implementation) (P < 0·001). Audits between 2003 and 2011 of 4368 patient medical records identified compliance with pressure ulcer prevention documentation according to best practice guidelines was high (>84%). A sample of 270 patients formed the sample for the study of risk assessment scoring accuracy and use of prevention strategies. It was found usual-care nurses under-estimated patients' risk of pressure ulcer development and under-utilised prevention strategies compared with experienced injury prevention nurses. Despite a significant reduction in prevalence of hospital-acquired pressure ulcers and high documentation compliance, use of prevention strategies could further be improved to achieve better patient outcomes. Barriers to the use of prevention strategies by nurses in the acute hospital setting require further examination. This study provides important insights into the knowledge translation of pressure ulcer prevention best practice guideline recommendations at The Northern Hospital.

The Australian multiple sclerosis (MS) immunotherapy study: A prospective, multicentre study of drug utilisation using the MSBase platform

To prospectively characterise treatment persistence and predictors of treatment discontinuation in an Australian relapsing-remitting multiple sclerosis (RRMS) population. Tertiary MS treatment centres participating in the MSBase registry prospectively assessed treatment utilisation, persistence, predictors of treatment discontinuation and switch rates. Multivariable survival analyses were used to compare treatment persistence between drugs and to identify predictors of treatment discontinuation. 1113 RRMS patients were studied. Patients persisted on their first disease-modifying therapy (DMT) for a median of 2.5 years. Treatment persistence on GA was shorter than on all IFNβ products (p<0.03). Younger age at treatment initiation and higher EDSS were predictive of DMT discontinuation. Patients persisted on subsequent DMTs, for 2.3 years. Patients receiving natalizumab (NAT) as a subsequent DMT persisted longer on treatment than those on IFNβ or GA (p<0.000). The primary reason for treatment discontinuation for any drug class was poor tolerability. Annualised switch or cessation rates were 9.5–12.5% for individual IFNβ products, 11.6% for GA and 4.4% for NAT. This multicentre MS cohort study is the first to directly compare treatment persistence on IFNβ and GA to NAT. We report that treatment persistence in our Australian RRMS population is short, although patients receiving IFNβ as a first DMT persisted longer on treatment than those on GA. Additionally, patients receiving NAT as a subsequent DMT were more likely to persist on treatment than those switched to IFNβ or GA. EDSS and age at DMT initiation were predictive of DMT discontinuation. Treatment intolerance was the principal reason for treatment cessation.

A qualitative study of the factors that influence mothers when choosing drinks for their young children

ABSTRACT

Birthweight and childhood cancer : preliminary findings from the International Childhood Cancer Cohort Consortium (I4C)

BACKGROUND: Evidence relating childhood cancer to high birthweight is derived primarily from registry and case-control studies. We aimed to investigate this association, exploring the potential modifying roles of age at diagnosis and maternal anthropometrics, using prospectively collected data from the International Childhood Cancer Cohort Consortium.

METHODS: We pooled data on infant and parental characteristics and cancer incidence from six geographically and temporally diverse member cohorts [the Avon Longitudinal Study of Parents and Children (UK), the Collaborative Perinatal Project (USA), the Danish National Birth Cohort (Denmark), the Jerusalem Perinatal Study (Israel), the Norwegian Mother and Child Cohort Study (Norway), and the Tasmanian Infant Health Survey (Australia)]. Birthweight metrics included a continuous measure, deciles, and categories (≥4.0 vs. <4.0 kilogram). Childhood cancer (377 cases diagnosed prior to age 15 years) risk was analysed by type (all sites, leukaemia, acute lymphoblastic leukaemia, and non-leukaemia) and age at diagnosis. We estimated hazard ratios (HR) and 95% confidence intervals (CI) from Cox proportional hazards models stratified by cohort.

RESULTS: A linear relationship was noted for each kilogram increment in birthweight adjusted for gender and gestational age for all cancers [HR = 1.26; 95% CI 1.02, 1.54]. Similar trends were observed for leukaemia. There were no significant interactions with maternal pre-pregnancy overweight or pregnancy weight gain. Birthweight ≥4.0 kg was associated with non-leukaemia cancer among children diagnosed at age ≥3 years [HR = 1.62; 95% CI 1.06, 2.46], but not at younger ages [HR = 0.7; 95% CI 0.45, 1.24, P for difference = 0.02].

CONCLUSION: Childhood cancer incidence rises with increasing birthweight. In older children, cancers other than leukaemia are particularly related to high birthweight. Maternal adiposity, currently widespread, was not demonstrated to substantially modify these associations. Common factors underlying foetal growth and carcinogenesis need to be further explored.

Effects of study design and allocation on participant behaviour-ESDA: study protocol for a randomized controlled trial

BACKGROUND: What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. METHODS/DESIGN: A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. DISCUSSION: The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000846022.

Cross-sectional and longitudinal associations between parents' and preschoolers' physical activity and TV viewing: the HAPPY Study

Background: Parental modelling has been shown to be important for school-aged children’s physical activity (PA) and television (TV) viewing, yet little is known about its impact for younger children. This study examined cross-sectional and three-year longitudinal associations between PA and TV viewing behaviours of parents and their preschool children. Method: In 2008-9 (T1), parents in the HAPPY cohort study (n=450) in Melbourne, Australia self-reported their weekly PA and TV viewing, and proxy-reported their partner’s PA and TV viewing, and their 3-5 year-old preschool child’s TV viewing. Children’s PA was assessed via accelerometers. Repeat data collection occurred in 2011-12 (T2). Results: Mothers’ and fathers’ PA were associated with PA among preschool girls at T1, but not boys. Parents’ TV viewing times were significant correlates of girls’ and boys’ TV viewing at T1. Longitudinally, mothers’ PA at baseline predicted boys’ PA at T2, while sex-specific associations were found for TV viewing, with mothers’ and fathers’ TV viewing at T1 associated with girls’ and boys’ TV viewing respectively at T2. Conclusions: The PA and TV viewing of both parents are significantly associated with these behaviours in preschool children. The influence of the sex-matched parent appears to be important longitudinally for children’s TV viewing&period.

Prevention of dabigatran-related gastrointestinal bleeding with gastroprotective agents: a population-based study

Background & Aims Use of dabigatran, an inhibitor of thrombin, increases the risk of gastrointestinal bleeding (GIB). However, it is not clear whether gastroprotective agents (GPAs) prevent GIB in dabigatran users. We investigated the risk of GIB and the role of gastroprotective agents (including proton pump inhibitors and histamine type-2-receptor antagonists) in patients using dabigatran. Methods We performed a retrospective cohort study using a population-wide database managed by the Hong Kong Hospital Authority. Patients newly prescribed dabigatran from 2010 through 2013 were included in the analysis. Poisson regression was used to assess the risk of GIB in dabigatran users by incidence rate ratio (IRR), adjusted for patient characteristics, comorbidities, and concurrent medications. Results Among the 5041 patients newly prescribed dabigatran, 124 (2.5%) developed GIB during follow-up evaluation (4.2/100 patient-years). The risk of GIB in this population increased among patients 75 years and older (IRR, 2.47; 95% confidence interval [CI], 1.66-3.68), patients with a history of peptic ulcers or GIB (IRR, 2.31; 95% CI, 1.54-3.46), and patients who used aspirin (IRR, 1.52; 95% CI, 1.03-2.24). Concomitant use of gastroprotective agents was associated with a reduced risk of GIB (IRR, 0.52; 95% CI, 0.35-0.77). Subcategory analysis showed that use of proton pump inhibitors (IRR, 0.53; 95% CI, 0.31-0.91) or histamine type-2-receptor antagonists (IRR, 0.61; 95% CI, 0.40-0.94) were associated with a lower risk of GIB. Further analysis showed that the risk reduction by gastroprotective agents was significant for only upper GIB (IRR, 0.29; 95% CI, 0.15-0.54), and only for patients with a prior history of peptic ulcers or GIB (IRR, 0.14; 95% CI, 0.06-0.30). Conclusions In the Hong Kong population, use of gastroprotective agents was associated with a reduced risk of GIB in patients taking dabigatran. The association was stronger for upper GIB than lower GIB, and in patients with a prior history of peptic ulcers or GIB.

The extra resource burden of in-hospital falls: a cost of falls study

OBJECTIVE: To quantify the additional hospital length of stay (LOS) and costs associated with in-hospital falls and fall injuries in acute hospitals in Australia. DESIGN, SETTING AND PARTICIPANTS: A multisite prospective cohort study conducted during 2011-2013 in the control wards of a falls prevention trial (6-PACK). The trial included all admissions to 12 acute medical and surgical wards of six Australian hospitals. In-hospital falls data were collected from medical record reviews, daily verbal reports by ward nurse unit managers, and hospital incident reporting and administrative databases. Clinical costing data were linked for three of the six participating hospitals to calculate patient-level costs. OUTCOME MEASURES: Hospital LOS and costs associated with in-hospital falls and fall injuries for each patient admission. RESULTS: We found that 966 of a total of 27 026 hospital admissions (3.6%) involved at least one fall, and 313 (1.2%) at least one fall injury, a total of 1330 falls and 418 fall injuries. After adjustment for age, sex, cognitive impairment, admission type, comorbidity and clustering by hospital, patients who had an in-hospital fall had a mean increase in LOS of 8 days (95% CI, 5.8-10.4; P < 0.001) compared with non-fallers, and incurred mean additional hospital costs of $6669 (95% CI, $3888-$9450; P < 0.001). Patients with a fall-related injury had a mean increase in LOS of 4 days (95% CI, 1.8-6.6; P = 0.001) compared with those who fell without injury, and there was also a tendency to additional hospital costs (mean, $4727; 95% CI, -$568 to $10 022; P = 0.080). CONCLUSION: Patients who experience an in-hospital fall have significantly longer hospital stays and higher costs. Programs need to target the prevention of all falls, not just the reduction of fall-related injuries.

A prospective observational study of prevalence and outcomes of patients with Gold Standard Framework criteria in a tertiary regional Australian Hospital

OBJECTIVES: Report the use of an objective tool, UK Gold Standards Framework (GSF) criteria, to describe the prevalence, recognition and outcomes of patients with palliative care needs in an Australian acute health setting. The rationale for this is to enable hospital doctors to identify patients who should have a patient-centred discussion about goals of care in hospital.

DESIGN: Prospective, observational, cohort study.

PARTICIPANTS: Adult in-patients during two separate 24 h periods.

MAIN OUTCOME MEASURES: Prevalence of in-patients with GSF criteria, documentation of treatment limitations, hospital and 1 year survival, admission and discharge destination and multivariate regression analysis of factors associated with the presence of hospital treatment limitations and 1 year survival.

RESULTS: Of 626 in-patients reviewed, 171 (27.3%) had at least one GSF criterion, with documentation of a treatment limitation discussion in 60 (30.5%) of those patients who had GSF criteria. Hospital mortality was 9.9%, 1 year mortality 50.3% and 3-year mortality 70.2% in patients with GSF criteria. One-year mortality was highest in patients with GSF cancer (73%), renal failure (67%) and heart failure (60%) criteria. Multivariate analysis revealed age, hospital length of stay and presence of the GSF chronic obstructive pulmonary disease criteria were independently associated with the likelihood of an in-hospital treatment limitation. Non-survivors at 3 years were more likely to have a GSF cancer (25% vs 6%, p=0.004), neurological (10% vs 3%, p=0.04), or frailty (45% vs 3%, p=0.04) criteria. After multivariate logistic regression GSF cancer criteria, renal failure criteria and the presence of two or more GSF clinical criteria were independently associated with increased risk of death at 3 years. Patients returning home to live reduced from 69% (preadmission) to 27% after discharge.

CONCLUSIONS: The use of an objective clinical tool identifies a high prevalence of patients with palliative care needs in the acute tertiary Australian hospital setting, with a high 1 year mortality and poor return to independence in this population. The low rate of documentation of discussions about treatment limitations in this population suggests palliative care needs are not recognised and discussed in the majority of patients.

TRIAL REGISTRATION NUMBER: 11/121.

Study protocol: the registrar clinical encounters in training (ReCEnT) study

Background
Patient encounters are the core learning activity of Australian general practice (family practice) training. Exposure to patient demographics and presentations may vary from one general practice registrar (vocational trainee) to another. This can affect comprehensiveness of training. Currently, there is no mechanism to systematically capture the content of GP registrar consultations. The aim of the Registrar Clinical Encounters in Training (ReCEnT) study is to document longitudinally the nature and associations of consultation-based clinical and educational experiences of general practice registrars.
Methods/design
This is an ongoing prospective multi-site cohort study of general practice registrars’ consultations, entailing paper-based recording of consultation data. The study setting is general practices affiliated with three geographically-based Australian general practice regional training providers. Registrars record details of 60 consecutive consultations. Data collected includes registrar demographics, details of the consultation, patient demographics, reasons for encounter and problems managed. Problems managed are coded with the International Classification of Primary Care (second edition) classification system. Additionally, registrars record educational factors related to the encounter. The study will follow the clinical exposure of each registrar six-monthly over the 18 months to two years (full-time equivalent) of their general practice training program.
Conclusions
The study will provide data on a range of factors (patient, registrar and consultation factors). This data will be used to inform a range of educational decisions as well as being used to answer educational research questions. We plan to use ReCEnT as a formative assessment tool for registrars and help identify and address educational needs. The study will facilitate program evaluation by the participating training providers and thus improve articulation of educational programs with practice experience. From the research point of view it will address an evidence gap – the in-practice clinical and educational experience of general practice trainees, determinants of these experiences, and the determinants of registrars’ patterns of practice (for example, prescribing practice) over the course of their training.

Depression as a risk factor for fracture in women: a 10 year longitudinal study

BACKGROUND: Previous research has demonstrated deficits in bone mineral density (BMD) among individuals with depression. While reduced BMD is a known risk for fracture, a direct link between depression and fracture risk is yet to be confirmed. METHODS: A population-based sample of women participating in the Geelong Osteoporosis Study was studied using both nested case-control and retrospective cohort study designs. A lifetime history of depression was identified using a semi-structured clinical interview (SCID-I/NP). Incident fractures were identified from radiological reports and BMD was measured at the femoral neck using dual energy absorptiometry. Anthropometry was measured and information on medication use and lifestyle factors was obtained via questionnaire. RESULTS: Among 179 cases with incident fracture and 914 controls, depression was associated with increased odds of fracture (adjusted odds ratio (OR) 1.57, 95%CI 1.04-2.38); further adjustment for psychotropic medication use appeared to attenuate this association (adjusted OR 1.52, 95%CI 0.98-2.36). Among 165 women with a history of depression at baseline and 693 who had no history of depression, depression was associated with a 68% increased risk of incident fracture (adjusted hazard ratio (HR) 1.68, 95%CI 1.02-2.76), with further adjustment for psychotropic medication use also appearing to attenuate this association (adjusted HR 1.58, 95%CI 0.95-2.61). LIMITATIONS: Potential limitations include recall bias, unrecognised confounding and generalizability. CONCLUSIONS: This study provides both cross-sectional and longitudinal evidence to suggest that clinical depression is a risk factor for radiologically-confirmed incident fracture, independent of a number of known risk factors. If there is indeed a clinically meaningful co-morbidity between mental and bone health, potentially worsened by psychotropic medications, the issue of screening at-risk populations needs to become a priority.