Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): a randomised control trial

Objectives To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.
Design Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
Setting 20 orthopaedic surgery centres in Australia and New Zealand.
Participants 902 patients undergoing elective primary or revision total hip replacement surgery.
Intervention 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
Main outcome measures Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).
Results There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
Conclusions These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
Trial registration NCT00145730.

Beating the blues after cancer : randomised control trial of a tele-based psychological intervention for high distress patients and carers

Background : The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention.

Methods/design : 140 patients and 140 carers per condition (560 participants in total) will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1) a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2) a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life.

Discussion : The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers.

A four week randomised control trial of adjunctive medroxyprogesterone and tamoxifen in women with mania

Emerging research has suggested that hormone treatments such as selective oestrogen receptor modulators (SERMs) or progestins may be useful in the treatment of mania. The current pilot study compared the use of the SERM tamoxifen and the progestin medroxyprogesterone acetate (MPA), as an adjunct to mood stabiliser medications, for the treatment of mania symptoms in 51 women in a 28-day double blind, placebo controlled study. The primary outcome was the change between baseline and day 28 mania scores as measured by the Clinician Administered Rating Scale for Mania (CARS-M). Adjunctive MPA treatment provided greater and more rapid improvement in mania symptoms compared with adjunctive placebo and tamoxifen treatment. Adjunctive therapy with MPA may be a potentially useful new treatment for persistent mania, leading to a greater and more rapid resolution of symptoms compared with mood stabiliser treatment alone.

Promoting healthy eating, active play and sustainability consciousness in early childhood curricula, addressing the Ben10™ problem: a randomised control trial

Background: This paper details the research protocol for a study funded by the Australian Research Council. An integrated approach towards helping young children respond to the significant pressures of ‘360 degree marketing’ on their food choices, levels of active play, and sustainability consciousness via the early childhood curriculum is lacking. The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children’s knowledge about healthy eating, active play and the sustainability consequences of their toy food and toy selections. Methods/Design: This cluster-randomised trial will be conducted with 300, 4 to 5 year-old children attending pre-school. Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating, active play and sustainability consciousness and deliver this to their pre-school class. Children will be interviewed about their knowledge of healthy eating, active play and the sustainability consequences of their food and toy selections. Parents will complete an Eating and Physical Activity Questionnaire rating their children’s food preferences, digital media viewing and physical activity habits. All measures will be administered at baseline, the end of the intervention and 6 months post intervention. Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group. Discussion: This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children’s healthy eating, active play, and sustainability consciousness. The significance of the early childhood period, for young children’s learning about healthy eating, active play and sustainability, is now unquestioned. The specific teaching and learning practices used by early childhood educators, as part of the intervention program, will incorporate a sociocultural perspective on learning; this perspective emphasises building on the play interests of children, that are experienced within the family and home context, as a basis for curriculum provision. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12614000363684: Date registered: 07/04/2014

The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.

The aim of the Youth Depression Alleviation-Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.

An integrated workplace mental health intervention in a policing context: protocol for a cluster randomised control trial

BACKGROUND: In this paper, we present the protocol for a cluster-randomised trial to evaluate the implementation and effectiveness of a workplace mental health intervention in the state-wide police department of the south-eastern Australian state of Victoria. n. The primary aims of the intervention are to improve psychosocial working conditions and mental health literacy, and secondarily to improve mental health and organisational outcomes.

METHODS/DESIGN: The intervention was designed collaboratively with Victoria Police based on a mixed methods pilot study, and combines multi-session leadership coaching for the senior officers within stations (e.g., Sergeants, Senior Sergeants) with tailored mental health literacy training for lower and upper ranks. Intervention effectiveness will be evaluated using a two-arm cluster-randomised trial design, with 12 police stations randomly assigned to the intervention and 12 to the non-intervention/usual care control condition. Data will be collected from all police members in each station (estimated at >20 per station). Psychosocial working conditions (e.g., supervisory support, job control, job demands), mental health literacy (e.g., knowledge, confidence in assisting someone who may have a mental health problem), and mental health will be assessed using validated measures. Organisational outcomes will include organisational depression disclosure norms, organisational cynicism, and station-level sickness absence rates. The trial will be conducted following CONSORT guidelines. Identifying data will not be collected in order to protect participant privacy and to optimise participation, hence changes in primary and secondary outcomes will be assessed using a two-sample t-test comparing summary measures by arm, with weighting by cluster size.

DISCUSSION: This intervention is novel in its integration of stressor-reduction and mental health literacy-enhancing strategies. Effectiveness will be rigorously evaluated, and if positive results are observed, the intervention will be adapted across Victoria Police (total employees ~16,500) as well as possibly in other policing contexts, both nationally and internationally.

The impact of an exercise physiologist coordinated resistance exercise program on the physical function of people receiving hemodialysis: a stepped wedge randomised control study

Background:

Study protocol for a randomised controlled trial of internet-based cognitive-behavioural therapy for obsessive-compulsive disorder.

Obsessive-Compulsive Disorder (OCD) is a common chronic psychiatric disorder that constitutes a leading cause of disability. Although Cognitive-Behaviour Therapy (CBT) has been shown to be an effective treatment for OCD, this specialised treatment is unavailable to many due to access issues and the social stigma associated with seeing a mental health specialist. Internet-based psychological treatments have shown to provide effective, accessible and affordable treatment for a range of anxiety disorders, and two Randomised Controlled Trials (RCTs) have demonstrated the efficacy and acceptability of internet-based CBT (iCBT) for OCD, as compared to waitlist or supportive therapy. Although these initial findings are promising, they do not isolate the specific effect of iCBT. This paper details the study protocol for the first randomised control trial evaluating the efficacy of therapist-assisted iCBT for OCD, as compared to a matched control intervention; internet-based therapist-assisted progressive relaxation training (iPRT). It will aim to examine whether therapist-assisted iCBT is an acceptable and efficacious treatment, and to examine how effectiveness is influenced by patient characteristics.

Skills training to avoid inadvertent plagiarism: results from a randomised control study

Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall knowledge about in-text referencing protocols. Importantly, this knowledge was found to translate into applied skills, with the intervention group performing significantly better in a practical skills application task. Moreover, the findings suggest that it is confidence in writing in English, not language background per se, which plays a significant role in students' practical skills in referencing and their confidence in performing assignment preparation tasks that can help them avoid claims of inadvertent plagiarism.

Testing the feasibility of a mobile technology intervention promoting healthy gestational weight gain in pregnant women (txt4two) - study protocol for a randomised controlled trial.

BACKGROUND: Overweight, obesity and excess gestational weight gain (GWG) are associated with negative health outcomes for mother and child in pregnancy and across the life course. Interventions promoting GWG within guidelines report mixed results. Most are time and cost intensive, which limits scalability. Mobile technologies (mHealth) offer low cost, ready access and individually-tailored support. We aim to test the feasibility of an mHealth intervention promoting healthy nutrition, physical activity and GWG in women who begin pregnancy overweight or obese. METHODS/DESIGN: txt4two is a parallel randomised control trial pilot recruiting women with a singleton, live gestation between 10(+0) and 17(+6) weeks at the first hospital antenatal clinic visit. Inclusion criteria are pre-pregnancy BMI > 25 kg/m(2) and mobile phone ownership. One hundred consenting women will be randomised to intervention or control groups at a 1:1 ratio. All participants will receive standard antenatal care. In addition, the txt4two intervention will be delivered from baseline to 36 weeks gestation and consists of a tailored suite of theoretically-grounded, evidence-based intervention strategies focusing on healthy nutrition, physical activity and GWG. This includes: mobile phone interactive text messages promoting positive health behaviours, goal setting and self-monitoring; video messages; an information website; and a private moderated Facebook® chat forum. The primary outcome is the feasibility of the intervention. Secondary outcomes include GWG and participants' knowledge and behaviour regarding diet and physical activity during pregnancy. DISCUSSION: Findings will inform the development of larger-scale mHealth programmes to improve the delivery of healthy pregnancy nutrition, physical activity and GWG, that could be widely translated and disseminated. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRNU111111544397 . Date of registration: 19 March 2014.

Calcium- and vitamin D3 - fortified milk reduces bone loss at clinically relevant skeletal sites on llder men: a 2-year randomised controlled trial

In this 2-year randomized controlled study of 167 men >50 years of age, supplementation with calcium-vitamin D3-fortified milk providing an additional 1000 mg of calcium and 800 IU of vitamin D3 per day was effective for suppressing PTH and stopping or slowing bone loss at several clinically important skeletal sites at risk for fracture.

Introduction: Low dietary calcium and inadequate vitamin D stores have long been implicated in age-related bone loss and osteoporosis. The aim of this study was to assess the effects of calcium and vitamin D3 fortified milk on BMD in community living men >50 years of age.

Materials and Methods: This was a 2-year randomized controlled study in which 167 men (mean age ± SD, 61.9 ± 7.7 years) were assigned to receive either 400 ml/day of reduced fat (1%) ultra-high temperature (UHT) milk containing 1000 mg of calcium plus 800 IU of vitamin D3 or to a control group receiving no additional milk. Primary endpoints were changes in BMD, serum 25(OH)D, and PTH.

Results: One hundred forty-nine men completed the study. Baseline characteristics between the groups were not different; mean dietary calcium and serum 25(OH)D levels were 941 ± 387 mg/day and 77 ± 23 nM, respectively. After 2 years, the mean percent change in BMD was 0.9-1.6% less in the milk supplementation compared with control group at the femoral neck, total hip, and ultradistal radius (range, p < 0.08 to p < 0.001 after adjusting for covariates). There was a greater increase in lumbar spine BMD in the milk supplementation group after 12 and 18 months (0.8-1.0%, p ≤ 0.05), but the between-group difference was not significant after 2 years (0.7%; 95% CI, −0.3, 1.7). Serum 25(OH)D increased and PTH decreased in the milk supplementation relative to control group after the first year (31% and −18%, respectively; both p < 0.001), and these differences remained after 2 years. Body weight remained unchanged in both groups at the completion of the study.

Conclusions: Supplementing the diet of men >50 years of age with reduced-fat calcium- and vitamin D3-enriched milk may represent a simple, nutritionally sound and cost-effective strategy to reduce age-related bone loss at several skeletal sites at risk for fracture in the elderly.

Randomised controlled trial evaluating lifestyle interventions in people with impaired glucose tolerance

Aim

To evaluate the effectiveness of lifestyle interventions in people with impaired glucose tolerance (IGT).
Methods

Participants with IGT (n = 78), diagnosed on two consecutive oral glucose tolerance tests (OGTTs), were randomly assigned to a 2-year lifestyle intervention or to a control group. Main outcome measures were changes from baseline in: nutrient intake; physical activity; anthropometry, glucose tolerance and insulin sensitivity. Measurements were repeated at 6, 12 and 24 months follow-up.
Results

After 24 months follow-up, there was a significant fall in total fat consumption (difference in change between groups (Δ intervention − Δ control) = −17.9, 95% confidence interval (CI) −33.6 to −2.1 g/day) as a result of the intervention. Body mass was significantly lower in the intervention group compared with controls after 6 months (−1.6, 95% CI −2.9 to −0.4 kg) and 24 months (−3.3, 95% CI −5.7 to −0.89 kg). Whole body insulin sensitivity, assessed by the short insulin tolerance test (ITT), improved after 12 months in the intervention group (0.52, 95% CI 0.15–0.89%/min).
Conclusions

These findings complement the findings of the Finnish Diabetes Prevention Study and the American Diabetes Prevention Study, both of which tested intensive interventions, by showing that pragmatic lifestyle interventions result in improvements in obesity and whole body insulin sensitivity in individuals with IGT, without change in other cardiovascular risk factors.