Study protocol for "Moving bright, eating smart"- a phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors

Background: Colorectal cancer is the second most common cancer and cancer-killer in Hong Kong with an alarming increasing incidence in recent years. The latest World Cancer Research Fund report concluded that foods low in fibre, and high in red and processed meat cause colorectal cancer whereas physical activity protects against
colon cancer. Yet, the influence of these lifestyle factors on cancer outcome is largely unknown even though cancer survivors are eager for lifestyle modifications. Observational studies suggested that low intake of a Western-pattern diet and high physical activity level reduced colorectal cancer mortality. The Theory of Planned
Behaviour and the Health Action Process Approach have guided the design of intervention models targeting a wide range of health-related behaviours.
Methods/design: We aim to demonstrate the feasibility of two behavioural interventions intended to improve colorectal cancer outcome and which are designed to increase physical activity level and reduce consumption of a Western-pattern diet. This three year study will be a multicentre, randomised controlled trial in a 2x2 factorial
design comparing the “Moving Bright, Eating Smart” (physical activity and diet) programme against usual care. Subjects will be recruited over a 12-month period, undertake intervention for 12 months and followed up for a further 12 months. Baseline, interim and three post-intervention assessments will be conducted. Two hundred and twenty-two colorectal cancer patients who completed curative treatment without evidence of recurrence will be recruited into the study. Primary outcome measure will be whether physical activity and dietary targets are met at the end of the 12-month intervention. Secondary outcome measures include the magnitude and
mechanism of behavioural change, the degree and determinants of compliance, and the additional health benefits and side effects of the intervention.
Discussion: The results of this study will establish the feasibility of targeting the two behaviours (diet and physical activity) and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III randomised controlled trial with colorectal cancer outcome as the study endpoint to determine whether this intervention model would reduce colorectal cancer recurrence and mortality.

Reduced emergency calls and improved weekend discharge after introduction of a new electronic handover system

Objectives: To measure the frequency and content of electronic handover before and after implementation of the Blue BARRWUE handover system, and to measure its effect on patient safety and hospital efficiency over weekends.

Design, setting and participants: Point-prevalence study comparing outcomes for general medical inpatients present over weekends before implementation (1 May 2008 to 30 April 2009) and after implementation (1 May 2009 to 30 April 2010) of the Blue BARRWUE handover system at Geelong Hospital.

Intervention: Implementation of the Blue BARRWUE handover system and its components (updated working diagnosis, background, alerts, resuscitation status, requests, who to do what and when, updates and executable discharge plan).
Main outcome measures: Presence of any written handover notes or updated working diagnoses in the BOSSnet clinical information system, content of handover notes, frequency of weekend discharges and medical emergency team (MET) calls before and after implementation.

Results: In the 12 months before implementation of the Blue BARRWUE handover system, 976 patients (47.98%) had a handover note in BOSSnet, versus 1646 patients (95.09%) in the 12 months after implementation (P< 0.001; rate ratio [RR], 20.75; 95% CI, 16.33–26.44). Before implementation, 289 patients (14.21%) were discharged over weekends, versus 353 patients (20.39%) after implementation, (P < 0.001; RR, 1.44; 95% CI, 1.25–1.65). MET calls were made for 152 general medical patients before implementation (7.47%), versus 95 general medical patients (5.49%) after implementation (P= 0.01; RR, 0.73; 95% CI, 0.57–0.94).

Conclusions: The Blue BARRWUE system has sustainably improved written handover in our organisation and was associated with improvement in both patient safety and hospital efficiency.

Personal and psychosocial impacts of clinical fracture in men

Background : Little is known about the personal burden of fracture across the age spectrum, particularly in men. This study aimed to document the impact of clinical fracture on men's participation in employment, sports and outdoor recreation, mobility, handiwork, activities of daily living, home modification, and utilisation of community and health services.

Methods : This prospective study followed 196 men with incident fracture identified from radiology reports at the Geelong Hospital during the period July 2006 to December 2007 and examined personal and psychosocial impacts 12 months post-fracture, using a self-report questionnaire.

Results : Of all men identified with fracture, 40% took time off work. All fractures, except those to the upper limbs, had considerable impact on mobility. Inability to drive was associated with all fractures, but was most common with ankle fractures and most prolonged with hip fractures. Loss of confidence was reported by over one-third of all fracture cases, even 12 months after the fracture event. All fractures affected activities of daily living, and this was generally most prolonged for fractures of the hip. Similarly, all men with fracture utilised community and health services, even for the relatively minor fractures of the finger/thumb.

Conclusions : This study supports previous reports of the personal impact of hip fracture, and presents data about the consequences of upper and lower limb fractures and the generally poorly described sequelae of fractures of the finger/thumb and foot/toe. These observations have important implications for post-fracture care and rehabilitation in men.

The TrueBlue model of collaborative care using practice nurses as case managers for depression alongside diabetes or heart disease: a randomised trial

Objectives:
To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers.

Structured Type 1 Diabetes education delivered within routine care: impact on glycemic control and diabetes-specific quality of life

OBJECTIVE:
To determine whether improvements in glycemic control and diabetes-specific quality of life (QoL) scores reported in research studies for the type 1 diabetes structured education program Dose Adjustment For Normal Eating (DAFNE) are also found when the intervention is delivered within routine U.K. health care.

RESEARCH DESIGN AND METHODS:
Before and after evaluation of DAFNE to assess impact on glycemic control and QoL among 262 adults with type 1 diabetes.

RESULTS:
There were significant improvements in HbA_1c from baseline to 6 and 12 months (from 9.1 to 8.6 and 8.8%, respectively) in a subgroup with suboptimal control. QoL was significantly improved by 3 months and maintained at both follow-up points.

CONCLUSIONS:
Longer-term improved glycemic control and QoL is achievable among adults with type 1 diabetes through delivery of structured education in routine care, albeit with smaller effect sizes than reported in trials.

Does the shortage of diabetes specialists in regional and rural Australia matter? Results from Diabetes MILES – Australia.

Aim: To investigate differences in access to services and health outcomes between people living with Type 1 (T1DM) and Type 2 (T2DM) diabetes in rural/regional and metropolitan areas.

Methods: Diabetes MILES—Australia was a national postal/online survey of persons registered with the National Diabetes Services Scheme. Selected variables, including utilisation of health care services and self-care indicators, were analysed for 3338 respondents with T1DM (41%) or T2DM (59%).

Results: Respondents from rural/regional (n=1574, 48%) and metropolitan areas were represented equally (n=1700, 52%). After adjusting for diabetes duration, demographic and socioeconomic variables, rural/regional respondents with T1DM (RR 0.90, 95% CI 0.83–0.97) and T2DM (RR 0.69, 95% CI 0.59–0.81) were less likely to report consulting an endocrinologist during the past 12 months. Rural/regional respondents with T1DM were more than twice as likely to have accessed a community/practice nurse for diabetes care (RR 2.22, 95% CI 1.25–3.93) while those with T2DM were more likely to have accessed a diabetes educator (RR 1.21, 95% CI 1.07–1.36) or dietician (RR 1.17, 95% CI 1.07–1.36). For the T1DM and T2DM groups were no differences between rural/regional and metropolitan respondents in self-reported hypoglycaemic events during past week and the majority of self-care indicators.

Conclusions: Despite a lack of access to medical specialists, respondents with T1DM and T2DM living in rural/regional areas did not report worse health or self-care indicators. The results suggest that multidisciplinary primary services in rural areas may be providing additional care for people with diabetes, compensating for poor access to specialists.

Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomised controlled trial

Background

Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation.

This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge.

We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08).

Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation. 

Improving gambling survey research using dual-frame sampling of landline and mobile phone numbers

Gambling prevalence studies are typically conducted within a single (landline) telephone sampling frame. This practice continues, despite emerging evidence that significant differences exist between landline and mobile (cell) phone only households. This study utilised a dual-frame (landline and mobile) telephone sampling methodology to cast light on the extent of differences across groups of respondents in respect to demographic, health, and gambling characteristics.

A total of 2,014 participants from across Australian states and territories ranging in age from 18 to 96 years participated. Interviews were conducted using computer assisted telephone interviewing technology where 1,012 respondents from the landline sampling frame and 1,002 from the mobile phone sampling frame completed a questionnaire about gambling and other health behaviours. Responses across the landline sampling frame, the mobile phone sampling frame, and the subset of the mobile phone sampling frame that possessed a mobile phone only (MPO) were contrasted.

The findings revealed that although respondents in the landline sample (62.7 %) did not significantly differ from respondents in the mobile phone sample (59.2 %) in gambling participation in the previous 12 months, they were significantly more likely to have gambled in the previous 12 months than the MPO sample (56.4 %). There were no significant differences in internet gambling participation over the previous 12 months in the landline sample (4.7 %), mobile phone sample (4.7 %) and the MPO sample (5.0 %). However, endorsement of lifetime problem gambling on the NODS-CLiP was significantly higher within the mobile sample (10.7 %) and the MPO sample (14.8 %) than the landline sample (6.6 %).

Our research supports previous findings that reliance on a traditional landline telephone sampling approach effectively excludes distinct subgroups of the population from being represented inresearch findings. Consequently, we suggest that research best practice necessitates the use of a dual- rame sampling methodology. Despite inherent logistical and cost issues, this approach  needs to become the norm in gambling survey research.

Mothers after gestational diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

Background:
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.

Methods/Design:
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.

Discussion:
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.

A parallel-group, randomised controlled trial of a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners: design and rationale

Introduction:

Breeding periodicity for male sea turtles, operational sex ratios, and implications in the face of climate change

Species that have temperature-dependent sex determination (TSD) often produce highly skewed offspring sex ratios contrary to long-standing theoretical predictions. This ecological enigma has provoked concern that climate change may induce the production of single-sex generations and hence lead to population extirpation. All species of sea turtles exhibit TSD, many are already endangered, and most already produce sex ratios skewed to the sex produced at warmer temperatures (females). We tracked male loggerhead turtles (Caretta caretta) from Zakynthos, Greece, throughout the entire interval between successive breeding seasons and identified individuals on their breeding grounds, using photoidentification, to determine breeding periodicity and operational sex ratios. Males returned to breed at least twice as frequently as females. We estimated that the hatchling sex ratio of 70:30 female to male for this rookery will translate into an overall operational sex ratio (OSR) (i.e., ratio of total number of males vs females breeding each year) of close to 50:50 female to male. We followed three male turtles for between 10 and 12 months during which time they all traveled back to the breeding grounds. Flipper tagging revealed the proportion of females returning to nest after intervals of 1, 2, 3, and 4 years were 0.21, 0.38, 0.29, and 0.12, respectively (mean interval 2.3 years). A further nine male turtles were tracked for short periods to determine their departure date from the breeding grounds. These departure dates were combined with a photoidentification data set of 165 individuals identified on in-water transect surveys at the start of the breeding season to develop a statistical model of the population dynamics. This model produced a maximum likelihood estimate that males visit the breeding site 2.6 times more often than females (95%CI 2.1, 3.1), which was consistent with the data from satellite tracking and flipper tagging. Increased frequency of male breeding will help ameliorate female-biased hatchling sex ratios. Combined with the ability of males to fertilize the eggs of many females and for females to store sperm to fertilize many clutches, our results imply that effects of climate change on the viability of sea turtle populations are likely to be less acute than previously suspected.

Problem gambling and family violence : family member reports of prevalence, family impacts and family coping

There exists only a small number of empirical studies investigating the patterns of family violence in problem gambling populations, although some evidence exists that intimate partner violence and child abuse are among the most severe interpersonal correlates of problem gambling. The current article reports on the Australian arm of a large-scale study of the patterns and prevalence of co-occurrence of family violence and problem gambling in Australia, New Zealand and Hong Kong. The current study screened 120 help-seeking family members of problem gamblers in a range of clinical services for both family violence and problem gambling. The main results showed that 52.5% reported some form of family violence in the past 12 months: 20.0% reported only victimisation, 10.8% reported only perpetration and 21.6% reported both victimisation and perpetration of family violence. Parents, current and ex-partners were most likely to be both perpetrators and victims of family violence. There were no gender differences in reciprocal violence but females were more likely to be only victims and less likely to report no violence in comparison to males. Most of the 32 participants interviewed in depth, reported that gambling generally preceded family violence. The findings suggest that perpetration of family violence was more likely to occur as a reaction to deeply-rooted and accumulated anger and mistrust whereas victimisation was an outcome of gambler’s anger brought on by immediate gambling losses and frustration. While multiple and intertwined negative family impacts were likely to occur in the presence of family violence, gambling-related coping strategies were not associated with the presence or absence of family violence. The implications of the findings for service providers are discussed.

Carrying weapons and intent to harm among Victorian secondary school students in 1999 and 2009

Objective: 

Reducing office workers' sitting time: rationale and study design for the Stand Up Victoria cluster randomized trial

Background
Excessive time spent in sedentary behaviours (sitting or lying with low energy expenditure) is associated with an increased risk for type 2 diabetes, cardiovascular disease and some cancers. Desk-based office workers typically accumulate high amounts of daily sitting time, often in prolonged unbroken bouts. The Stand Up Victoria study aims to determine whether a 3-month multi-component intervention in the office setting reduces workplace sitting, particularly prolonged, unbroken sitting time, and results in improvements in cardiometabolic biomarkers and work-related outcomes, compared to usual practice.

Methods/design
A two-arm cluster-randomized controlled trial (RCT), with worksites as the unit of randomization, will be conducted in 16 worksites located in Victoria, Australia. Work units from one organisation (Department of Human Services, Australian Government) will be allocated to either the multi-component intervention (organisational, environmental [heightadjustable workstations], and individual behavioural strategies) or to a usual practice control group. The recruitment target is 160 participants (office-based workers aged 18–65 years and working at least 0.6 full time equivalent) per arm. At each assessment (0- [baseline], 3- [post intervention], and 12-months [follow-up]), objective measurement via the activPAL3 activity monitor will be used to assess workplace: sitting time (primary outcome); prolonged sitting time (sitting time accrued in bouts of ≥30 minutes); standing time; sit-to-stand transitions; and, moving time. Additional outcomes assessed will include: non-workplace activity; cardio-metabolic biomarkers and health indicators (including fasting glucose, lipids and insulin; anthropometric measures; blood pressure; and, musculoskeletal symptoms); and, work-related outcomes (presenteeism, absenteeism, productivity, work performance). Incremental cost-effectiveness and identification of both workplace and individual-level mediators and moderators of change will also be evaluated.

Retinal venular caliber predicts visual outcome after intravitreal ranibizumab injection treatments for neovascular AMD

Purpose