Developing and validating a scale to measure the perceptions of safety, usability and acceptability of microarray patches for vaccination: a study protocol.

Background: Vaccination is a fundamental tenet of public and population health. Several barriers to vaccine uptake exist, exacerbated post-COVID-19, including misconceptions about vaccine efficacy and safety, vaccine hesitancy, vaccine inequity, costs, religious beliefs, and insufficient education and guidance for healthcare professionals. Vaccine uptake may be aided using microarray patches (MAPs) due to reduced pain, no hypodermic needle, enhanced thermostability, and potential for self and lay administration. Objectives: This protocol outlines the development of a scale that aims to accurately measure the perceived safety, usability, and acceptability of MAPs for vaccination among laypeople, MAP recipients, clinicians, and parents or guardians of children. Methods and analysis: This study will follow three phases of scale development and validation, including (1) item development, (2) scale development, and (3) scale evaluation. Inductive (interviews) and deductive methods (literature searches) will be used to develop scale items, which experts from target populations will assess through an online survey. Cognitive interviews will be conducted to observe their processes of answering the draft survey. Thematic analysis will be conducted to analyse qualitative data. Lastly, four surveys will be administered online to our target populations over two time points to determine their repeatability. Exploratory and confirmatory factor analyses, Cronbach's alpha, and construct validity will be performed. Ethics: This study was approved by Metro South Health (HREC/2021/QMS/81653) and Western Sydney Local Health District (2023/ETH00705) Human Research Ethics Committees. Discussion: The scale will support a standardised approach to assessing the social and behavioural aspects of MAP vaccines, enabling comparison of outcomes across studies. Once validated, this scale will assist vaccination programmes in developing effective strategies for integrating MAPs and overcoming barriers to vaccination. This includes improving vaccine equity and accessibility, especially in lower- and middle-income countries and rural or remote locations.

Health benefits and harms of mammography screening in older women (75+ years)-a systematic review.

BACKGROUND: There is little evidence on the balance between potential benefits and harms of mammography screening in women 75 years and older. The aim of this systematic review was to synthesise the evidence on the outcomes of mammography screening in women aged 75 years and older. METHODS: A systematic review of mammography screening studies in women aged 75 years and over. RESULTS: Thirty-six studies were included in this review: 27 observational studies and 9 modelling studies. Many of the included studies used no or uninformative comparison groups resulting in a potential bias towards the benefits of screening. Despite this, there was mixed evidence about the benefits and harms of continuing mammography screening beyond the age of 75 years. Some studies showed a beneficial effect on breast cancer mortality, and other studies showed no effect on mortality. Some studies showed some harms (false positive tests and recalls) being comparable to those in younger age-groups, with other studies showing increase in false positive screens and biopsies in older age-group. Although reported in fewer studies, there was consistent evidence of increased overdiagnosis in older age-groups. CONCLUSION: There is limited evidence available to make a recommendation for/against continuing breast screening beyond the age of 75 years. Future studies should use more informative comparisons and should estimate overdiagnosis given potentially substantial harm in this age-group due to competing causes of death. This review was prospectively registered with PROSPERO (CRD42020203131).

Immunogenicity, safety, usability and acceptability of microarray patches for vaccination: a systematic review and meta-analysis.

BACKGROUND: Microarray patches (MAPs) deliver vaccines to the epidermis and the upper dermis, where abundant immune cells reside. There are several potential benefits to using MAPs, including reduced sharps risk, thermostability, no need for reconstitution, tolerability and self-administration. We aimed to explore and evaluate the immunogenicity, safety, usability and acceptability of MAPs for vaccination. METHODS: We searched CINAHL, Cochrane Library, Ovid Embase, Ovid MEDLINE and Web of Science from inception to January 2023. Eligibility criteria included all research studies in any language, which examined microarrays or microneedles intended or used for vaccination and explored immunogenicity, safety, usability or acceptability in their findings. Two reviewers conducted title and abstract screening, full-text reviewing and data extraction. RESULTS: Twenty-two studies were included (quantitative=15, qualitative=2 and mixed methods=5). The risk of bias was mostly low, with two studies at high risk of bias. Four clinical trials were included, three using influenza antigens and one with Japanese encephalitis delivered by MAP. A meta-analysis indicated similar or higher immunogenicity in influenza MAPs compared with needle and syringe (N&S) (standardised mean difference=10.80, 95% CI: 3.51 to 18.08, p<0.00001). There were no significant differences in immune cell function between MAPs and N&S. No serious adverse events were reported in MAPs. Erythema was more common after MAP application than N&S but was brief and well tolerated. Lower pain scores were usually reported after MAP application than N&S. Most studies found MAPs easy to use and highly acceptable among healthcare professionals, laypeople and parents. CONCLUSION: MAPs for vaccination were safe and well tolerated and evoked similar or enhanced immunogenicity than N&S, but further research is needed. Vaccine uptake may be increased using MAPs due to less pain, enhanced thermostability, layperson and self-administration. MAPs could benefit at-risk groups and low and middle-income countries. PROSPERO REGISTRATION NUMBER: CRD42022323026.

Junior parkrun pilot in Australia: A real world evaluation.

ISSUE ADDRESSED: Regular physical activity is important for children's health. Parkrun supports communities to deliver free, weekly, 5 km events in 22 countries around the world and is the largest physical activity model delivered at scale in the world. Junior parkrun aims to encourage children aged 4-14 years to be active outdoors through providing safe, cost-free and non-competitive weekly timed walk, run or jog over a 2-km distance. The aim of this study is to evaluate the junior parkrun pilot in Australia. METHODS: A process evaluation was conducted using routinely collected data of junior parkrun participants, as well as a self-completed questionnaire. RESULTS: A total of 1827 children had registered and participated in at least one junior parkrun over the course of the pilot period. Participants had, on average, attended 10% of the junior parkrun events including and subsequent to their first participation by the end of the study period. Majority of parents (61%) said that junior parkrun had increased their child's physical activity either a little or a lot, and most agreed or strongly agreed that junior parkrun was fun (90%), enjoyable (91%), energising (85%) and challenging (70%). CONCLUSION: The junior parkrun pilot appears to show promise in Australia for enabling children to engage in physical activity, in their local communities in a fun and inclusive way. SO WHAT: Parkrun junior can co-exist with other organised sports programs; however, it can also specifically target those not participating in any sports, given the high levels of enjoyment in a non-competitive, non-team environment.

Patient-reported health-related quality of life outcomes following mastectomy for breast cancer, with immediate, delayed or no breast reconstruction: Four-year follow-up from a prospective cohort study.

BACKGROUND: Breast reconstruction (BR) improves women's health-related quality of life (HRQOL) following mastectomy for breast cancer, yet factors contributing to improved HRQOL remain unclear. This study aimed to explore the overall impact of mastectomy with or without BR on participants' perceptions of HRQOL over time in a cohort of women with high-risk breast cancer; to examine differences in mean HRQOL scores between immediate BR, delayed BR and no BR groups; to assess the influence of patient characteristics potentially associated with HRQOL scores; and to determine the feasibility of long-term collection of patient-reported outcome measures in clinical settings. METHODS: A prospective, longitudinal study of 100 women with high-risk breast cancer who underwent mastectomy with or without breast reconstruction and were likely to require post-mastectomy radiotherapy. Four validated patient-reported questionnaires, comprising 21 outcome measures relating to HRQOL, administered at baseline and up to 4 years post-mastectomy. Demographic, clinical and surgical data extracted from patient medical records. RESULTS: Consistently significant declines in perceptions of future health and arm symptoms, consistently significant improvements in treatment side effects, breast symptoms and fatigue, as well as significant improvements, compared to baseline, in social functioning and financial difficulties at 48 months. No significant differences in mean HRQOL scores between women given a choice of reconstructive options. CONCLUSION: Similar trajectories of HRQOL scores were found in women with high-risk breast cancer who were offered a choice of BR. Informed choice may be an independent contributing factor in long-term maintenance of most HRQOL indicators at their pre-mastectomy levels.

Rapid assessment of case recruitment tools to inform integrated surveillance of influenza and other respiratory viruses in Eastern Mediterranean countries.

Influenza-like illness (ILI) and severe acute respiratory infection (SARI) case recruitment tools from 10 countries were reviewed. The contents of the existing tools were compared against World Health Organization's current guidelines, and we also assessed the content validity (accuracy, completeness and consistency). Five of the ILI tools and two of the SARI tools were rated as having high accuracy against WHO case definitions. ILI completeness ranged from 25% to 86% and SARI from 52% to 96%. Average internal consistency scores were 86% for ILI and 94% for SARI. Limitations in the content validity of influenza case recruitment tools may compromise recruitment of eligible cases and result in varying detection rates across countries.

The psychometric properties of a novel task-based dance self-efficacy measure for older adult dance program participants.

BACKGROUND: Self-efficacy for dance may reflect individual differences in factors likely to influence dance program participation. This study investigated the psychometric properties of six novel task-based dance self-efficacy (t-bDSE) questions for older adults participating in two large-scale dance intervention trials (N1 = 530; N2 = 131). METHODOLOGY: Internal consistency of t-bDSE was assessed and items validated according to age, gender, physical ability, cognitive status, psychosocial wellbeing, dance experience and exercise behaviour. Responsiveness of t-bDSE was investigated by comparing dance program participants to control groups. RESULTS: Internal consistency was high (Cronbach's α = .88). Dance self-efficacy was weaker in participantswith less dance experience, poorer mental health, poorer cognitive and physical abilities, and insufficiently active. t-bDSE scores improved in aged-care trial participants (ηp2 = .05, a moderate effect). CONCLUSIONS: The dance self-efficacy measure demonstrated good criterion and construct validity and can be included in future dance interventions to improve understanding of outcome variability and inform program evaluation.

The role of breast reconstruction choice on body image patient-reported outcomes at four years post-mastectomy for breast cancer: A longitudinal prospective cohort study.

OBJECTIVES: To examine the impact of breast reconstruction on women's perceptions of body image over time and to assess the influence of sociodemographic variables on body image. METHODS: A prospective, longitudinal cohort study, using validated breast cancer-specific questionnaires, to compare patient-reported outcomes in women choosing immediate (n = 61), delayed (n = 16) or no (n = 23) breast reconstruction. RESULTS: One hundred women completed baseline questionnaires that included items on body image; 30 women completed all four annual follow-up sets, while 20 women completed baseline only. The three groups were well matched at baseline and similar trajectories in body image measures were identified over 48 months in all groups. At 12 months post-mastectomy, significant changes were seen in eight of the 10 subscales; this reduced to seven subscales at 24 months and four at 36 months. By 48 months, only three subscales remained significantly different to baseline scores: women remained less vulnerable and had fewer limitations (improved outcomes); the one worse outcome was persistently higher levels of arm concern. Three of the sociodemographic variables (health insurance, age and employment status) showed significant inter-group differences at some time points. CONCLUSION: These findings suggest women recover from the negative impact of mastectomy on body image within four years of surgery, whether they have immediate, delayed or no reconstruction. Our results provide some indirect evidence that having a choice of BR options is important, regardless of the choice made. Four years appears to be a suitable follow-up period for future studies in this area.

The Effect of Supplemental Imaging on Interval Cancer Rates in Mammography Screening: Systematic Review.

Supplemental screening with MRI or ultrasound increases cancer detection rate (CDR) in women with standard screening mammography. Whether it also reduces interval cancer rate (ICR) is unclear. This study reviewed the evidence evaluating the effect of supplemental imaging on ICR in women undergoing screening mammography. This systematic review included studies that reported both CDR and ICR in women undergoing screening mammography alone compared to those undergoing screening mammography with supplemental imaging. Five studies (3 randomized trials) were eligible. These reported on 142,153 women undergoing mammography screening alone or mammography with supplemental imaging (3 ultrasound and 2 MRI studies). Two studies included a general screening population and 3 included special populations (young, high genetic risk and/or dense breasts). The incremental CDR for supplemental MRI was 14.2 to 16.5/1000 screens and for ultrasound was 0 to 4.4/1000 screens. Effect on ICR was variable but evidence of a reduced ICR was more consistent for studies using supplemental MRI (ICR 0.3 to 0.8 per 1000 screens) than those using ultrasound (ICR 0.49 to 1.9 per 1000 screens). The higher CDR and lower ICR with supplemental screening were associated with higher recall and biopsy rates particularly with supplemental MRI (9.5%-15.9%, up to 69/1000 screens). Cancers detected with supplemental imaging modalities were generally smaller and earlier stage. Mammography with supplemental MRI or ultrasound increases detection of cancers (versus mammography only) in some sub-groups but also increases recall and biopsy rates and may have a relatively modest effect in reducing ICR.

Impact of the age expansion of breast screening on screening uptake and screening outcomes among older women in BreastScreen western.

OBJECTIVES: To assess the impact of age expansion of screening (EOS) of the target age group from 50 to 69 to 50-74 in Australia, which began mid-2013, by examining screening uptake and outcomes of older women, and by identifying factors associated with continuing screening after reaching the age of 75 years. METHODS: Retrospective study using data from women aged 65+ who attended BreastScreen Western Australia between 2010 and 2017 for free mammograms. Screening uptake and screening outcomes were calculated for the periods before (2010-2012) and after (2015-2017) the age EOS to women aged 70-74. Logistic regression was used to identify variables associated with continuing screening after reaching age 75 years, while controlling for possible confounding variables. RESULTS: Age EOS increased screening uptake amongst women aged 70-74 b y 36% and amongst women ≥75 years by 3% while screening uptake in women aged 65-69 decreased by 3%. Rate of invasive screened-detected cancers significantly decreased among women aged 70-74 from 11.4/1000 screens before to 8.1/1000 screens after age EOS. Likelihood of continuing screening into age ≥75 years was higher in women who had a personal history or a family history of breast cancer, or used hormone replacement therapy within six months of screening. Women who were born outside Australia were less likely to continue screening after reaching age 75 years. CONCLUSIONS: Our study found that age EOS to women aged 70-74 was effective in increasing screening uptake in this age-group but was accompanied by a moderate increase in screening uptake amongst women ≥75 years via self-referral for whom potential benefit of screening may be limited.

Mortality of ethnic minority groups in the UK: a systematic review protocol.

INTRODUCTION: Growing ethnic diversity in the UK has made it increasingly important to determine the presence of ethnic health inequalities. There has been no systematic review that has drawn together research on ethnic differences in mortality in the UK. METHODS: All types of observational studies that compare all-cause mortality between major ethnic groups and the white majority population in the UK will be included. We will search Medline (OvidSP), Embase (OvidSP), Scopus and Web of Science and search the grey literature through conference proceedings and online thesis registries. Searches will be carried out from inception to 2 August 2019 with no language or other restrictions. Database searches will be repeated prior to publication to identify new articles published since the initial search. We will conduct forward and backward citation tracking of identified references and consult with experts in the field to identify further publications and ongoing or unpublished studies. Two reviewers will independently screen studies and extract data. Two reviewers will independently assess the quality of included studies using the Newcastle-Ottawa Scale. If at least two studies are located for each ethnic group and studies are sufficiently homogeneous, we will conduct a meta-analysis. If insufficient studies are located or if there is high heterogeneity we will produce a narrative summary of results. ETHICS AND DISSEMINATION: As no primary data will be collected, formal ethical approval is not required. The findings of this review will be disseminated through publication in peer reviewed journals and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42019146143.

Low-Level Laser Treatment Is Ineffective for Capsular Contracture: Results of the LaTCon Randomized Controlled Trial.

BACKGROUND: Breast reconstruction with implants can be complicated by symptomatic capsular contracture, especially after radiotherapy. A phase I, nonrandomized clinical trial demonstrated improvement in capsular contracture and avoidance of revision surgery with low-level laser therapy. This phase II, double-blind, randomized controlled trial assessed the efficacy of low-level laser for treating capsular contracture in women with breast reconstruction following mastectomy for breast cancer. METHODS: Participants had completed their definitive implant-based reconstruction a minimum of 6 months previously and were randomized to weekly treatments over 6 weeks with either an active or inactive low-level laser handpiece (Riancorp LTU-904). Pain, tightness, arm movement, and appearance were assessed by patient questionnaires. Breast symmetry, shape, naturalness, softness, and grade of contracture were assessed by clinician reports. Participants were assessed at 1 and 6 months after completion of the treatments. RESULTS: A total of 42 patients (intervention arm, n = 20; placebo, n = 22) were assessed in the trial. Thirty-two had postmastectomy radiotherapy. There was no significant difference in the change in any patient-reported outcomes or clinician-reported outcomes of breast symmetry, shape, or naturalness for the two groups. There was a significantly greater improvement in clinician-reported breast softness (p < 0.05) and degree of contracture (p < 0.05) in the placebo group at both 1- and 6-month follow-up. CONCLUSION: Low-level laser is not an effective therapy for breast implant capsular contracture in reconstruction patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Simulated versus traditional occupational therapy placements: A randomised controlled trial.

BACKGROUND/AIM: Professional practise placements in occupational therapy education are critical to ensuring graduate competence. Australian occupational therapy accreditation standards allow up to 200 of a mandated 1000 placement hours to include simulation-based learning. There is, however, minimal evidence about the effectiveness of simulation-based placements compared to traditional placements in occupational therapy. We evaluated whether occupational therapy students completing a 40 hour (one week block) Simulated Clinical Placement (SCP) attained non-inferior learning outcomes to students attending a 40 hour Traditional Clinical Placement (TCP). METHODS: A pragmatic, non-inferiority, assessor-blinded, multicentre, randomised controlled trial involving students from six Australian universities was conducted. Statistical power analysis estimated a required sample of 425. Concealed random allocation was undertaken with a 1:1 ratio within each university. Students were assigned to SCP or TCP in one of three settings: vocational rehabilitation, mental health or physical rehabilitation. SCP materials were developed, manualised and staff training provided. TCPs were in equivalent practice areas. Outcomes were assessed using a standardised examination, unit grades, the Student Practice Evaluation Form-Revised and student confidence survey. A generalised estimating equation approach was used to assess non-inferiority of the SCP to the TCP. RESULTS: Of 570 randomised students (84% female), 275 attended the SCP and 265 the TCP (n = 540, 94.7% retention). There were no significant differences between the TCP and SCP on (i) examination results (marginal mean difference 1.85, 95% CI: 0.46-3.24; P = 0.087); (ii) unit score (mean (SD) SCP: 71.9 (8.8), TCP: 70.34 (9.1); P = 0.066); or (iii) placement fail rate, assessed using the Student Practice Evaluation Form-Revised (100% passed both groups). CONCLUSION: Students can achieve equivalent learning outcomes in a 40 hour simulated placement to those achieved in a 40 hour traditional placement. These findings provide assurance to students, educators and professional accreditation bodies that simulation can be embedded in occupational therapy education with good effect.

Effectiveness and cost-effectiveness of embedded simulation in occupational therapy clinical practice education: study protocol for a randomised controlled trial.

BACKGROUND: Clinical placements are a critical component of the training for health professionals such as occupational therapists. However, with growing student enrolments in professional education courses and workload pressures on practitioners, it is increasingly difficult to find sufficient, suitable placements that satisfy program accreditation requirements. The professional accrediting body for occupational therapy in Australia allows up to 200 of the mandatory 1000 clinical placement hours to be completed via simulation activities, but evidence of effectiveness and efficiency for student learning outcomes is lacking. Increasingly placement providers charge a fee to host students, leading educators to consider whether providing an internal program might be a feasible alternative for a portion of placement hours. Economic analysis of the incremental costs and benefits of providing a traditional versus simulated placement is required to inform decision-making. METHODS/DESIGN: This study is a pragmatic, non-inferiority, single-blind, multicentre, two-group randomised controlled trial (RCT) with an embedded economic analysis. The RCT will compare a block of 40 hours of simulated placement (intervention) with a 40-hour block of traditional placement (comparator), with a focus on student learning outcomes and delivery costs. Six universities will instigate the educational intervention within their respective occupational therapy courses, randomly assigning their cohort of students (1:1 allocation) to the simulated or traditional clinical placements. The primary outcome is achievement of professional behaviours (e.g. communication, clinical reasoning) as assessed by a post-placement written examination. Secondary outcomes include proportions passing the placement assessed using the Student Practice Evaluation Form-Revised, changes in student confidence pre-/post-placement, student and educator evaluation of the placement experience and cost-effectiveness of simulated versus traditional clinical placements. Comprehensive cost data will be collected for both the simulated and traditional placement programs at each site for economic evaluation. DISCUSSION: Use of simulation in health-related fields like occupational therapy is common, but these activities usually relate to brief opportunities for isolated skill development. The simulated clinical placement evaluated in this trial is less common because it encapsulates a 5-day block of integrated activities, designed and delivered in a manner intended to emulate best-practice placement experiences. The planned study is rare due to inclusion of an economic analysis that aims to provide valuable information about the relationship between costs and outcomes across participating sites. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001339448 . Registered 26 September 2016.

Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

BACKGROUND: The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. METHODS AND FINDINGS: A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. MAIN OUTCOMES: falls during the 12 mo trial and Trail Making Tests. SECONDARY OUTCOMES: The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control participants (82%, p = 0.04). Mean attendance at dance classes was 51%. During the period, 444 falls were recorded; there was no significant difference in fall rates between the control group (0.80 per person-year) and the dance group (1.03 per person-year). Using negative binomial regression with robust standard errors the adjusted Incidence Rate Ratio (IRR) was 1.19 (95% CI: 95% CI = 0.83, 1.71). In exploratory post hoc subgroup analysis, the rate of falls was higher among dance participants with a history of multiple falls (IRR = 2.02, 95% CI: 1.15, 3.54, p = 0.23 for interaction) and with the folk dance intervention (IRR = 1.68, 95% CI: 1.03, 2.73). There were no significant between-group differences in executive function test (TMT-B = 2.8 s, 95% CI: -6.2, 11.8). Intention to treat (ITT) analysis revealed no between-group differences at 12-mo follow-up in the secondary outcome measures, with the exception of postural sway, favouring the control group. Exploratory post hoc analysis by study completers and style indicated that ballroom dancing participants apparently improved their gait speed by 0.07 m/s relative to control participants (95% CI: 0.00, 0.14, p = 0.05). Study limitations included allocation to style based on logistical considerations rather than at random; insufficient power to detect differential impacts of different dance styles and smaller overall effects; variation of measurement conditions across villages; and no assessment of more complex balance tasks, which may be more sensitive to changes brought about by dancing. CONCLUSIONS: Social dancing did not prevent falls or their associated risk factors among these retirement villages' residents. Modified dance programmes that contain "training elements" to better approximate structured exercise programs, targeted at low and high-risk participants, warrant investigation. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry ACTRN12612000889853.

A theoretical analysis showed that blinding cannot eliminate potential for bias associated with beliefs about allocation in randomized clinical trials.

OBJECTIVES: To explore the theoretical justification for blinding in randomized trials and make recommendations concerning the implementation and interpretation of blinded randomized trials. STUDY DESIGN AND SETTING: A theoretical analysis was conducted of the potential for bias in randomized trials with successful blinding (ie, trials in which beliefs about allocation to treatment or control groups are independent of actual allocation). The analysis identified conditions that must be satisfied to ensure that blinding eliminates the potential for bias associated with beliefs about allocation. RESULTS: Even when beliefs about allocation are independent of actual allocation, they can still cause bias. The potential for bias is eliminated when the belief is uniformly one of complete ambivalence about allocation. CONCLUSION: Even when blinding succeeds in making beliefs about allocation independent of actual allocation, beliefs about allocation may still cause bias. It is difficult to determine the extent of bias in any particular trial. Bias could be eliminated by establishing a state of complete ambivalence about the allocation of every trial participant, but universal ambivalence may be difficult to achieve and may reduce the generalizability of the trial's findings.

Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial.

BACKGROUND: Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the 'holistic' approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have indicated that diverse dance styles can improve measures of balance and mobility in older people, but none of these studies has examined the effect of dance on falls or cognition. This study aims to determine whether participation in social dancing: i) reduces the number of falls; and ii) improves cognitive functions associated with fall risk in older people. METHODS/DESIGN: A single-blind, cluster randomised controlled trial of 12 months duration will be conducted. Approximately 450 participants will be recruited from 24 self-care retirement villages that house at least 60 residents each in Sydney, Australia. Village residents without cognitive impairment and obtain medical clearance will be eligible. After comprehensive baseline measurements including physiological and cognitive tests and self-completed questionnaires, villages will be randomised to intervention sites (ballroom or folk dance) or to a wait-listed control using a computer randomisation method that minimises imbalances between villages based on two baseline fall risk measures. Main outcome measures are falls, prospectively measured, and the Trail Making cognitive function test. Cost-effectiveness and cost-utility analyses will be performed. DISCUSSION: This study offers a novel approach to balance training for older people. As a community-based approach to fall prevention, dance offers older people an opportunity for greater social engagement, thereby making a major contribution to healthy ageing. Providing diversity in exercise programs targeting seniors recognises the heterogeneity of multicultural populations and may further increase the number of taking part in exercise. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000889853The trial is now in progress with 12 villages already have been randomised.

Internet-based randomized controlled trials: a systematic review.

BACKGROUND: The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two. OBJECTIVE: To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality. METHODS: A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out. RESULTS: 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%). CONCLUSIONS: It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods.