Development and validation of measures to evaluate adolescents' knowledge about human papillomavirus (HPV), involvement in HPV vaccine decision-making, self-efficacy to receive the vaccine and fear and anxiety

Objectives: We describe the development and validation of measures of human papillomavirus (HPV)/HPV vaccination knowledge, fear/anxiety about vaccination, involvement in HPV vaccine decision-making, and self-efficacy with regard to getting the vaccine, designed to evaluate the efficacy of an intervention to affect these domains (collectively termed the HAVIQ: HPV Adolescent Vaccine Intervention Questionnaire). / Study design: Literature search, cognitive interviews and cross-sectional survey. / Methods: A literature search identified existing items that were modified for the present measures. Experts reviewed draft measures for face and content validity. Cognitive interviews with adolescents were also used to assess content validity. Adolescents completed the measures and an internal reliability analysis of each measure was performed. / Results: The four experts concurred that the measures had face validity. Cognitive interviews identified items requiring refinement. Content validity was examined with ten experts and was deemed acceptable. There were 1800 adolescents who completed the measures; Cronbach's alpha was >0.6 for three of the four measures. The four final measures are brief, comprising 25 items in total. / Conclusions: The measures are robustly developed and validity-tested. The HAVIQ may be used in research settings to evaluate adolescents' knowledge and experiences of the process of HPV vaccination in a school-based vaccination programme

Legacy effects of statins on cardiovascular and all-cause mortality: A meta-analysis

© Author(s) (or their employer(s)) 2018. Objectives To assess evidence for 'legacy' (post-trial) effects on cardiovascular disease (CVD) mortality and all-cause mortality among adult participants of placebocontrolled randomised controlled trials (RCTs) of statins. Design Meta-analysis of aggregate data. Setting/Participants Placebo-controlled statin RCTS for primary and secondary CVD prevention. Methods Data sources: PubMed, Embase from inception and forward citations of Cholesterol Treatment Trialists' Collaborators RCTs to 16 June 2016. Study selection: Two independent reviewers identified all statin RCT follow-up reports including ≥1000 participants, and cardiovascular and all-cause mortality. Data extraction and synthesis: Two independent reviewers extracted data in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Main outcomes: Post-trial CVD and all-cause mortality. Results We included eight trials, with mean post-trial follow-up ranging from 1.6 to 15.1 years, and including 13 781 post-trial deaths (6685 CVD). Direct effects of statins within trials were greater than legacy effects posttrials. The pooled data from all eight studies showed no evidence overall of legacy effects on CVD mortality, but some evidence of legacy effects on all-cause mortality (p=0.01). Exploratory subgroup analysis found possible differences in legacy effect for primary prevention trials compared with secondary prevention trials for both CVD mortality (p=0.15) and all-cause mortality (p=0.02). Pooled post-trial HR for the three primary prevention studies demonstrated possible post-trial legacy effects on CVD mortality (HR=0.87; 95% CI 0.79 to 0.95) and on all-cause mortality (HR=0.90; 95% CI 0.85 to 0.96). Conclusions Possible post-trial statin legacy effects on all-cause mortality appear to be driven by the primary prevention studies. Although these relative benefits were smaller than those observed within the trial, the absolute benefits may be similar for the two time periods. Analysis of individual patient data from follow-up studies after placebo-controlled statin RCTs in lower-risk populations may provide more definitive evidence on whether early treatment of subclinical atherosclerosis is likely to be beneficial

Influences on condom use: A secondary analysis of women's perceptions from the Australian Contraceptive ChOice pRoject (ACCORd) trial.

Background and objectives Women’s ability to negotiate condom use helps prevent sexually transmissible infections (STIs) and unintended pregnancies. The aim of this study was to assess the relationship between substance use, risk perception and the certainty of using condoms in several hypothetical situations. Methods This is a secondary analysis from the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial. Descriptive statistics and logistic regression were used for the analysis. Results At baseline, contraceptive questions were answered by 698 women attending 57 general practices in Melbourne, Australia. Condom use was reported by 47%. Of those using condoms as the sole form of contraception (n = 137), 20% used them inconsistently. Dual protection was used by 58% of women (188/325). Condoms and the pill were more frequently used than condoms and longer-acting contraceptives. Women were less likely to be confident negotiating condom use when using substances. Discussion Substance use and the concurrent use of other forms of contraception impact use of condoms. Even when condoms are the sole form of contraception with willing partners, use is inconsistent, leaving women at risk of pregnancy and STI

Obstetric outcomes for women with female genital mutilation at an Australian hospital, 2006-2012: A descriptive study

© 2016 The Author(s). Background: Women, who have been subjected to female genital mutilation (FGM), can suffer serious and irreversible physical, psychological and psychosexual complications. They have more adverse obstetric outcomes as compared to women without FGM. Exploratory studies suggest radical change to abandonment of FGM by communities after migration to countries where FGM is not prevalent. Women who had been subjected to FGM as a child in their countries of origin, require specialised healthcare to reduce complications and further suffering. Our study compared obstetric outcomes in women with FGM to women without FGM who gave birth in a metropolitan Australian hospital with expertise in holistic FGM management. Methods: The obstetric outcomes of one hundred and ninety-six women with FGM who gave birth between 2006 and 2012 at a metropolitan Australian hospital were analysed. Comparison was made with 8852 women without FGM who gave birth during the same time period. Data were extracted from a database specifically designed for women with FGM and managed by midwives specialised in care of these women, and a routine obstetric database, ObstetriX. The accuracy of data collection on FGM was determined by comparing these two databases. All women with FGM type 3 were deinfibulated antenatally or during labour. The outcome measures were (1) maternal: accuracy and grade of FGM classification, caesarean section, instrumental birth, episiotomy, genital tract trauma, postpartum blood loss of more than 500 ml; and (2) neonatal: low birth weight, admission to a special care nursery, stillbirth. Results: The prevalence of FGM in women who gave birth at the metropolitan hospital was 2 to 3 %. Women with FGM had similar obstetric outcomes to women without FGM, except for statistically significant higher risk of first and second degree perineal tears, and caesarean section. However, none of the caesarean sections were performed for FGM indications. The ObstetriX database was only 35 % accurate in recording the correct FGM type. Conclusion: Women with FGM had similar obstetric outcomes to women without FGM in an Australian metropolitan hospital with expertise in FGM management. Specialised FGM services with clinical practice guideline and education of healthcare professionals may increase the detection rate of FGM and improve obstetric management of women with FGM

Quality of life among caregivers of people with end-stage kidney disease managed with dialysis or comprehensive conservative care

BACKGROUND: To measure health-related and care-related quality of life among informal caregivers of older people with end-stage kidney disease (ESKD), and to determine the association between caregiver quality of life and care recipient's treatment type. METHODS: A prospective cross-sectional study was conducted. Three renal units in the UK and Australia were included. Informal caregivers of people aged ≥75 years with ESKD managed with dialysis or comprehensive conservative non-dialytic care (estimated glomerular filtration (eGFR) ≤10 mL/min/1.73m2) participated. Health-related quality of life (HRQoL) was assessed using Short-Form six dimensions (SF-6D, 0-1 scale) and care-related quality of life was assessed using the Carer Experience Scale (CES, 0-100 scale). Linear regression assessed associations between care-recipient treatment type, caregiver characteristics and the SF-6D utility index and CES scores. RESULTS: Of 63 caregivers, 49 (78%) were from Australia, 26 (41%) cared for an older person managed with dialysis, and 37 (59%) cared for an older person managed with comprehensive conservative care. Overall, 73% were females, and the median age of the entire cohort was 76 years [IQR 68-81]. When adjusted for caregiver sociodemographic characteristics, caregivers reported significantly worse carer experience (CES score 15.73, 95% CI 5.78 to 25.68) for those managing an older person on dialysis compared with conservative care. However, no significant difference observed for carer HRQoL (SF-6D utility index - 0.08, 95% CI - 0.18 to 0.01) for those managing an older person on dialysis compared with conservative care. CONCLUSIONS: Our data suggest informal caregivers of older people on dialysis have significantly worse care-related quality of life (and therefore greater need for support) than those managed with comprehensive conservative care. It is important to consider the impact on caregivers' quality of life when considering treatment choices for their care recipients

Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol.

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019

A Mobile Health Lifestyle Program for Prevention of Weight Gain in Young Adults (TXT2BFiT): Nine-Month Outcomes of a Randomized Controlled Trial

BACKGROUND: The unprecedented rise in obesity among young adults, who have limited interaction with health services, has not been successfully abated. OBJECTIVE: The objective of this study was to assess the maintenance outcomes of a 12-week mHealth intervention on prevention of weight gain in young adults and lifestyle behaviors at 9 months from baseline. METHODS: A two-arm, parallel, randomized controlled trial (RCT) with subjects allocated to intervention or control 1:1 was conducted in a community setting in Greater Sydney, Australia. From November 2012 to July 2014, 18- to 35-year-old overweight individuals with a body mass index (BMI) of 25-31.99 kg/m2 and those with a BMI ≥ 23 kg/m2 and a self-reported weight gain of ≥ 2 kg in the past 12 months were recruited. A 12-week mHealth program "TXT2BFiT" was administered to the intervention arm. This included 5 coaching calls, 96 text messages, 12 emails, apps, and downloadable resources from the study website. Lifestyle behaviors addressed were intake of fruits, vegetables, sugar-sweetened beverages (SSBs), take-out meals, and physical activity. The control group received 1 phone call to introduce them to study procedures and 4 text messages over 12 weeks. After 12 weeks, the intervention arm received 2 further coaching calls, 6 text messages, and 6 emails with continued access to the study website during 6-month follow-up. Control arm received no further contact. The primary outcome was weight change (kg) with weight measured at baseline and at 12 weeks and self-report at baseline, 12 weeks, and 9 months. Secondary outcomes were change in physical activity (metabolic equivalent of task, MET-mins) and categories of intake for fruits, vegetables, SSBs, and take-out meals. These were assessed via Web-based surveys. RESULTS: Two hundred and fifty young adults enrolled in the RCT. Intervention participants weighed less at 12 weeks compared with controls (model β=-3.7, 95% CI -6.1 to -1.3) and after 9 months (model β=- 4.3, 95% CI - 6.9 to - 1.8). No differences in physical activity were found but all diet behaviors showed that the intervention group, compared with controls at 9 months, had greater odds of meeting recommendations for fruits (OR 3.83, 95% CI 2.10-6.99); for vegetables (OR 2.42, 95% CI 1.32-4.44); for SSB (OR 3.11, 95% CI 1.47-6.59); and for take-out meals (OR 1.88, 95% CI 1.07-3.30). CONCLUSIONS: Delivery of an mHealth intervention for prevention of weight gain resulted in modest weight loss at 12 weeks with further loss at 9 months in 18- to 35-year-olds. Although there was no evidence of change in physical activity, improvements in dietary behaviors occurred, and were maintained at 9 months. Owing to its scalable potential for widespread adoption, replication trials should be conducted in diverse populations of overweight young adults. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; (Archived by WebCite at http://www.webcitation.org/6i6iRag55)