Randomised controlled trial of amoxycillin clavulanate in children with chronic wet cough

Background Despite guideline recommendations, there are no published randomised controlled trial data on the efficacy of antibiotics for chronic wet cough in children. The majority of children with chronic wet cough have protracted bacterial bronchitis (PBB), a recognised condition in multiple national guidelines. The authors conducted a parallel 1:1 placebo randomised controlled trial to test the hypothesis that a 2-week course of amoxycillin clavulanate is efficacious in the treatment of children with chronic wet cough. Methods 50 children (median age 1.9 years, IQR 0.9–5.1) with chronic (>3 weeks) wet cough were randomised to 2 weeks of twice daily oral amoxycillin clavulanate (22.5 mg/kg/dose) or placebo. The primary outcome was ‘cough resolution’ defined as a >75% reduction in the validated verbal category descriptive cough score within 14 days of treatment compared with baseline scores, or cessation of cough for >3 days. In selected children, flexible bronchoscopy and bronchoalveolar lavage (BAL) were undertaken at baseline. Results Cough resolution rates (48%) were significantly higher in children who received amoxycillin clavulanate compared with those who received placebo (16%), p=0.016. The observed difference between proportions was 0.32 (95% CI 0.08 to 0.56). Post treatment, median verbal category descriptive score in the amoxycillin clavulanate group of 0.5 (IQR 0.0–2.0) was significantly lower than in the placebo group, 2.25 (IQR 1.15–2.9) (p=0.02). Pre-treatment BAL data were consistent with PBB in the majority of children, with no significant difference between groups. Conclusion A 2-week course of amoxycillin clavulanate will achieve cough resolution in a significant number of children with chronic wet cough. BAL data support the diagnosis of PBB in the majority of these children.

Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet : The North Carolina enhanced WISEWOMAN project

Objective To determine if a clinic-based behavioral intervention program for low-income mid-life women that emphasizes use of community resources will increase moderate intensity physical activity (PA) and improve dietary intake. Methods Randomized trial conducted from May 2003 to December 2004 at one community health center in Wilmington, NC. A total of 236 women, ages 40–64, were randomized to receive an Enhanced Intervention (EI) or Minimal Intervention (MI). The EI consisted of an intensive phase (6 months) including 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls. Both phases included efforts to increase participants' use of community resources that promote positive lifestyle change. The MI consisted of a one-time mailing of pamphlets on diet and PA. Outcomes, measured at 6 and 12 months, included the comparison of moderate intensity PA between study groups as assessed by accelerometer (primary outcome) and questionnaire, and dietary intake assessed by questionnaire and serum carotenoids (6 months only). Results For accelerometer outcomes, follow-up was 75% at 6 months and 73% at 12 months. Though moderate intensity PA increased in the EI and decreased in the MI, the difference between groups was not statistically significant (p = 0.45; multivariate model, p = 0.08); however, moderate intensity PA assessed by questionnaire (92% follow-up at 6 months and 75% at 12 months) was greater in the EI (p = 0.01; multivariate model, p = 0.001). For dietary outcomes, follow-up was 90% for questionnaire and 92% for serum carotenoids at 6 months and 74% for questionnaire at 12 months. Dietary intake improved more in the EI compared to the MI (questionnaire at 6 and 12 months, p < 0.001; serum carotenoid index, p = 0.05; multivariate model, p = 0.03). Conclusion The EI did not improve objectively measured PA, but was associated with improved self-reported and objective measures of dietary intake.

Breathe easier online : evaluation of a randomized controlled pilot trial of an internet-based intervention to improve well-being in children and adolescents with a chronic respiratory condition

Background Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups. Objective To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition. Methods We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2). Results The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably. Conclusions Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition. Trial registration Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033;

A pilot trial of mobile, patient-performed teledermoscopy

BACKGROUND Early detection by skin self-examination (SSE) could improve outcomes from melanoma. Mobile teledermoscopy may aid this process. OBJECTIVES To establish clinical accuracy of SSE plus mobile teledermoscopy compared to clinical skin examination (CSE) and test whether providing people with detailed SSE instructions improves accuracy. METHODS Men and women 50-64 years (n=58) performed SSE plus mobile teledermoscopy in their homes between May and November 2013 and were given technical instructions plus detailed SSE instructions (intervention) or technical instructions only (control). Within three months, they underwent a CSE. Outcome measures included: a) body sites examined, lesions photographed, and missed; b) sensitivityof SSE plus mobile teledermoscopy compared to in-person CSE using either patients or lesions as denominator, and; c) concordance of telediagnosis with CSE. RESULTS: 49 of 58 randomised participants completed the study, and submitted 309 lesions to the teledermatologist (156 intervention; 153 control group). Intervention group participants were more likely to submit lesions from their legs compared to control (p=0.03), no other differences between groups in number or site of missed lesions.11 participants (22%) did not photograph 14 pigmented lesions the dermatologist considered worthwhile photographing or requiring clinical monitoring. Sensitivity of SSE plus mobile teledermoscopy was 81.8% (95% confidence interval 64.5-93.0) using the patient as the denominator and 41.9 (27.6-56.2) using the lesion as denominator.-There was substantial agreement between telediagnosis and CSE (Kappa =0.90) accounting for differential diagnoses. CONCLUSIONS SSE plus mobile teledermoscopy is promising for surveillance of particular lesions even without provision of detailed SSE instructions, but in the format tested in this study, consumers may overlook lesions and send many non-pigmented lesions. This investigation demonstrates that high quality dermoscopic images can be taken by patients at home and for those sent, telediagnosis is highly accurate.

The influence of social media on international students' choice of university and course

This thesis is a qualitative study of the influence of social media on the university and course decision making process of international students. It examines the role of social media in influencing international students' decisions on course and university selection and the role of social media in meeting their information needs. It also gathered inputs on how universities could engage, collaborate and communicate using social media communities and channels for more effective recruitment strategies.

Depressive symptoms and adverse outcomes from hospitalization in older adults : secondary outcomes of a trial of falls prevention education

Depression is common in older people and symptoms of depression are known to substantially increase during hospitalization. There is little known about predictors of depressive symptoms in older adults or impact of common interventions during hospitalization. This study aimed to describe the magnitude of depressive symptoms, shift of depressive symptoms and the impact of the symptoms of depression among older hospital patients during hospital admission and identify whether exposure to falls prevention education affected symptoms of depression. Participants (n = 1206) were older adults admitted within two Australian hospitals, the majority of participants completed the Geriatric Depression Scale – Short Form (GDS) at admission (n = 1168). Participants’ mean age was 74.7 (±SD 11) years and 47% (n = 551) were male. At admission 53% (619 out of 1168) of participants had symptoms of clinical depression and symptoms remained at the same level at discharge for 55% (543 out of 987). Those exposed to the low intensity education program had higher GDS scores at discharge than those in the control group (low intensity vs control n = 652, adjusted regression coefficient (95% CI) = 0.24 (0.02, 0.45), p = 0.03). The only factor other than admission level of depression that affected depressive symptoms change was if the participant was worried about falling. Older patients frequently present with symptoms of clinical depression on admission to hospital. Future research should consider these factors, whether these are modifiable and whether treatment may influence outcomes.

A randomised controlled trial of an online theory-based intervention to improve adult Australians' sun-protective behaviours

Objective. To evaluate the effectiveness of a single-session online theory of planned behaviour (TPB)-based intervention to improve sun-protective attitudes and behaviour among Australian adults. Methods. Australian adults (N = 534; 38.7% males; Mage = 39.3 years) from major cities (80.9%), regional (17.6%) and remote areas (1.5%)were recruited and randomly allocated to an intervention (N=265) and information only group (N = 267). The online intervention focused on fostering positive attitudes, perceptions of normative support, and control perceptions for sun protection. Participants completed questionnaires assessing standard TPB measures (attitude, subjective norm, perceived behavioural control, intention, behaviour) and extended TPB constructs of group norm (friends, family), personal norm, and image norm, pre-intervention (Time 1) and one week (Time 2) and one month post-intervention (Time 3). Repeated Measures Multivariate Analysis of Variance tested intervention effects across time. Results. Intervention participants reported more positive attitudes towards sun protection and used sunprotective measures more often in the subsequent month than participants receiving information only. The intervention effects on control perceptions and norms were non-significant. Conclusions. A theory-based online intervention fostering more favourable attitudes towards sun safety can increase sun protection attitudes and self-reported behaviour among Australian adults in the short term.

Facilitating lifestyle changes to manage menopausal symptoms in women with breast cancer: A randomized controlled pilot trial of The Pink Women’s Wellness Program

OBJECTIVE Women diagnosed as having breast cancer may experience difficulties with posttreatment effects such as menopausal symptoms. The aims of this pilot study were to (1) evaluate the impact of a multimodal lifestyle program on reducing menopausal symptoms in women with breast cancer and (2) examine the impact of the program on health-related quality of life (HRQoL) and adherence to lifestyle recommendations. METHODS Overall, 55 women aged 45 to 60 years with one moderate to severe menopausal symptom and a history of breast cancer were randomized into an intervention group (n = 26) or a control group (n = 29). Women in the intervention group received a lifestyle intervention (The Pink Women’s Wellness Program) that included clinical consultations and a tailored health education program. Measurements of menopausal symptoms (Greene Climacteric Scale), HRQoL (SF-12 and Functional Assessment of Cancer Therapy—Breast), and modifiable lifestyle factors (food intake, physical activity, smoking and alcohol use, and sleep disturbance) were taken at baseline and 12 weeks. RESULTS Women in the intervention group reported clinically significant reductions in many menopausal symptoms, specifically somatic symptoms (d = 0.52), vasomotor symptoms (d = 0.55), sexual dysfunction (d = .65), and overall menopausal symptoms (d = 0.54), at 12 weeks compared with the control group (d = 0.03, d = 0.24, d = 0.18, and d = 0.05, respectively). Women in the intervention group reported improvements in Functional Assessment of Cancer Therapy—Breast subscale scores, physical well-being and functional well-being, and Functional Assessment of Cancer Therapy—General total scores (intervention group: d = 0.54, d = 0.50, and d = 0.48, respectively; control group: d = 0.22, d = 0.11, and d = 0.05, respectively). CONCLUSIONS The Pink Women’s Wellness Program is effective in decreasing menopausal symptoms, thus improving HRQoL. This being a pilot study, further research is recommended to investigate the benefits of combining nonpharmacological interventions for women with breast cancer to reduce their treatment-related menopausal symptoms.

A randomized controlled trial of a program to reduce adolescent road-related medically-treated injuries

Background Injury is the leading cause of adolescent death and injury around the road is a common source of adolescent injuries. Skills for Preventing Injury in Youth (SPIY) is a comprehensive program developed in Australia for early adolescents (term-long curriculum, including looking out for friends, first-aid training coupled with teacher school-connectedness professional development). Jessors’ Protection-Risk Framework guided the program approach focusing on building protective relationships. Method A randomized controlled trial with 35 schools was undertaken. Students completed surveys at baseline, six-months post-intervention and twelve-months post intervention. There were 1686 students (56% female) who completed the twelve-month survey, including the Extended-Adolescent Injury Checklist whereby students self-report on medically-treated injuries over the previous three-months (only road-related items are reported in this study; cycling, motorcycle riding, pedestrian, and riding as a passenger). Randomly selected SPIY classes also participated in focus groups and reported on perceptions of SPIY and injury risk behavior. Results As a check of randomization baseline differences of the variables were examined, with no significant differences between intervention and control groups. At the 12-month follow-up, there were fewer medically-treated injuries among the intervention students compared with the control group, particularly associated with being a passenger. The process evaluation revealed students perceived change in injury risk and risk behaviors. Conclusions While data analyses are continuing, the results indicate that the program seeking to encourage adolescents to look out for their friends, build connections to school and provide first aid skills training goes some way to reducing self-reported medically-treated injuries around the road.

Randomized controlled trial of an improved version of MobileMums, an intervention for increasing physical activity in women with young children

Background Women with young children (<5 years) are an important group for physical activity intervention. Purpose To evaluate the feasibility, acceptability and efficacy of MobileMums- a physical activity intervention for women with young children. Methods Women were randomized to MobileMums (n=133) or a control group (n=130). MobileMums was delivered primarily via individually-tailored text messages. Moderate to vigorous physical activity (MVPA) was measured by self-report and accelerometer at baseline, end of the intervention (13-weeks) and 6-months later (9-months). Changes were analyzed using repeated measures models. Results MobileMums was feasible to deliver and acceptable to women. Self-reported MVPA duration (minutes/week) and frequency (days/week) increased significantly post intervention (13-week intervention effect 48.5 min/week, 95%CI [13.4, 82.9] and 1.6 days/week, 95%CI [0.6, 2.6]). Intervention effects were not maintained 6-months later. No effects observed in accelerometer-derived MVPA. Conclusions MobileMums increased women’s self-reported MVPA immediately post intervention. Future investigations need to target sustained physical activity improvements.

A phase II trial of brivanib in recurrent or persistent endometrial cancer: An NRG oncology/gynecologic oncology group study

PURPOSE Brivanib, an oral, multi-targeted tyrosine kinase inhibitor with activity against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR) was investigated as a single agent in a phase II trial to assess the activity and tolerability in recurrent or persistent endometrial cancer (EMC). PATIENTS AND METHODS Eligible patients had persistent or recurrent EMC after receiving one to two prior cytotoxic regimens, measurable disease, and performance status of ≤2. Treatment consisted of brivanib 800 mg orally every day until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) at six months and objective tumor response. Expression of multiple angiogenic proteins and FGFR2 mutation status was assessed. RESULTS Forty-five patients were enrolled. Forty-three patients were eligible and evaluable. Median age was 64 years. Twenty-four patients (55.8%) received prior radiation. Median number of cycles was two (range 1-24). No GI perforations but one rectal fistula were seen. Nine patients had grade 3 hypertension, with one experiencing grade 4 confusion. Eight patients (18.6%; 90% CI 9.6%-31.7%) had responses (one CR and seven PRs), and 13 patients (30.2%; 90% CI 18.9%-43.9%) were PFS at six months. Median PFS and overall survival (OS) were 3.3 and 10.7 months, respectively. When modeled jointly, VEGF and angiopoietin-2 expression may diametrically predict PFS. Estrogen receptor-α (ER) expression was positively correlated with OS. CONCLUSION Brivanib is reasonably well tolerated and worthy of further investigation based on PFS at six months in recurrent or persistent EMC.

CLEIMS: Outcomes of a randomised educational trial of extended immersion in medical simulation

To report the outcomes of a randomised educational trial of a new methodology for extended immersion in medical simulation for senior medical students. Clinical Learning through Extended Immersion in Medical Simulation (CLEIMS) is a new methodology for medical student learning. It involves senior students working in teams of 4-5 through the clinical progress of one or more patients over a week, utilising a range of simulation methodologies (simulated patient assessment, simulated significant other briefing, virtual story continuations, pig-trotter wound repair, online simulated on-call modules, interprofessional simulated ward rounds and high fidelity mannequin-based emergency simulations), to enhance learning in associated workshops and seminars. A randomised educational trial comparing the methodology to seminars and workshops alone began in 2010 and interim results were reported at last year’s conference. Updated results are presented here and final primary endpoint outcomes will be available by the time of the conference.