Erin Mathieu

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

AbstractBackgroundFalls 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/designA 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12612000889853 The trial is now in progress with 12 villages already have been randomised.

Helping women make choices about mammography screening : An online randomized trial of a decision aid for 40-year-old women

OBJECTIVE To evaluate the effect of a decision aid (DA) on womens knowledge of the benefits and harms of screening and on their ability to make an informed decision. METHODS An online randomized controlled trial among 321 women aged 38-45 years was conducted. Participants were randomized to either immediate or delayed access to the online DA which (i) explained the benefits and harms, (ii) included a values clarification exercise and a worksheet to support decision making. The primary outcome, knowledge of benefits and harms of screening, and secondary outcomes, informed choice (composite of knowledge, values and intention), anxiety and acceptability of the DA were measured using online questionnaires. RESULTS Women in the intervention group were more knowledgeable (mean score out of 10, 7.35 vs 6.27, p<0.001) and were more likely to have made a decision (82% vs 61% p<0.001). Of those who made a decision, women in the intervention group were less likely to start screening now (52% vs 65% p=0.05). There was no significant difference in the proportion of women who made an informed choice (71% intervention group vs 64% control group, p=0.24). The DA was helpful, balanced and clear, and did not make women anxious. CONCLUSIONS The DA increased knowledge and reduced indecision, without increasing feelings of anxiety. PRACTICE IMPLICATIONS This decision aid is easy to access online and could be an inexpensive way of supporting women aged 40 who are considering whether to start screening now, or wait until they are 50. The results of this study demonstrate the potential of DAs to help inform women about both the benefits and risks of screening at this age and to support women and clinicians in this decision making process.

Association Between Physical Activity and Risk of Bleeding in Children With Hemophilia

CONTEXT Vigorous physical activity is thought to increase risk of bleeds in children with hemophilia, but the magnitude of the risk is unknown. OBJECTIVE To quantify the transient increase in risk of bleeds associated with physical activity in children with hemophilia. DESIGN, SETTING, AND PARTICIPANTS A case-crossover study nested within a prospective cohort study was conducted at 3 pediatric hemophilia centers in Australia between July 2008 and October 2010. A total of 104 children and adolescent boys aged 4 through 18 years with moderate or severe hemophilia A or B were monitored for bleeds for up to 1 year. Following each bleed, the child or parent was interviewed to ascertain exposures to physical activity preceding the bleed. Physical activity was categorized according to expected frequency and severity of collisions. The risk of bleeds associated with physical activity was estimated by contrasting exposure to physical activity in the 8 hours before the bleed with exposures in two 8-hour control windows, controlling for levels of clotting factor in the blood. MAIN OUTCOME MEASURES Association of physical activity and factor level with risk of bleeding. RESULTS The participants were observed for 4839 person-weeks during which time 436 bleeds occurred. Of these, 336 bleeds occurred more than 2 weeks after the preceding bleed and were used in the primary analysis of risk. Compared with inactivity and category 1 activities (eg, swimming), category 2 activities (eg, basketball) were associated with a transient increase in the risk of bleeding (30.6% of bleed windows vs 24.8% of first control windows; odds ratio, 2.7; 95% CI, 1.7-4.8, P < .001). Category 3 activities (eg, wrestling) were associated with a greater transient increase in risk (7.0% of bleed windows vs 3.4% of first control windows; odds ratio, 3.7; 95% CI, 2.3-7.3, P < .001). To illustrate absolute risk increase, for a child who bleeds 5 times annually and is exposed on average to category 2 activities twice weekly and to category 3 activities once weekly, exposure to these activities was associated with only 1 of the 5 annual bleeds. For every 1% increase in clotting factor level, bleeding incidence was lower by 2% (95% CI, 1%-3%; P = .004). CONCLUSIONS In children and adolescents with hemophilia, vigorous physical activity was transiently associated with a moderate relative increase in risk of bleeding. Because the increased relative risk is transient, the absolute increase in risk of bleeds associated with physical activity is likely to be small.

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.

Internet trials: participant experiences and perspectives

BackgroundUse of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial.ObjectiveTo obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research.MethodsAll English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey.Results1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69%) would prefer to participate in Internet-based research compared to other modes of data collection in the future.ConclusionParticipants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants’ perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience – a perceived benefit – and lack of connectedness and understanding – a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials.

Feasibility of short message service to document bleeding episodes in children with haemophilia

The increasing emphasis on home‐based treatment for the management of children with haemophilia has meant that many of these children no longer regularly report to a medical facility. Consequently, it is difficult to monitor incidence of bleeding episodes. The aim of this study was to assess the feasibility of using a short message service (SMS) to monitor incidence of bleeding episodes in children with haemophilia. One hundred and four children with moderate and severe haemophilia A or B took part in a 1‐year prospective study between 2008 and 2010. Children or their parents were asked to maintain a bleeds diary. They received a weekly SMS asking whether there had been a bleeding episode in the preceding week. Response rates were calculated. Children were followed for a total of 4839 person‐weeks. SMS replies were received for 4201 weeks. Thus, the rate of follow‐up was 86.8%. Median responses rates were 94.2% (IQR: 86.1–100%). Weekly SMS is a feasible reporting tool for documenting bleeding episodes in children with haemophilia. It is associated with high response rates and minimal expense and intrusion. The use of SMS could be extended to encourage compliance to prophylactic treatment, particularly in adolescents with haemophilia.

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 trials findings.

The Internet and medical decision making: can it replace the role of health care providers?

The Internet is the most comprehensive collection of written material in the developed world. It contains the world’s largest medical library and has transformed the way health seekers search for information. Around the world, a large number of consumers are using the Internet to access health information. It is estimated that 80% of all US adults with Internet access use the Web to search for health information, and with an estimated 340 million North Americans with Internet access, the potential reach of health information is enormous. Access to the latest information empowers consumers to take a more active role in their health care, and has resulted in patients who are more knowledgeable about different options for treatment and are able to discuss, with more confidence, their health care with medical professionals. In this issue of Medical Decision Making, Couper and others report their findings on the role the Internet plays in patient decision making. In this cross-sectional survey, those patients who, over the past 2 years, had spoken with their health care providers about 1 of 9 specific medical procedures or tests were asked about other sources of information that were used in helping them make their decision. The study results show that 28% of patients used the Internet to obtain information related to a specific health decision. This proportion varied depending on the type of decision, with Internet usage rates being greatest for decisions that may have been perceived to involve significant risk (36% of patients making surgery decisions had used the Internet), and decreasing in correlation with decreases in perceived risk (22% of patients making screening decisions had used the Internet). As expected, Internet use was much higher in the younger age groups, and use gradually decreased as age increased (from 38% of those 40 to 49 years old using the Internet, to 14% in those older than 70 years). The data also indicate that those patients who used the Internet on a regular basis rated the Internet as the second most important source of information for making a decision behind their health care provider (family and friends were rated third, and media rated fourth). These results suggest that health care providers are still the most important source of information for patients when making a decision, and that a minority of patients are using the Internet to gain additional information to assist with their decision. However, these findings may not be a true representation of Internet use and medical decision making within the community. The results reported in the DECISIONS study are based entirely on responses from patients who discussed their decision with their health care provider and could potentially include an underestimation of Internet use and an overestimation of the importance of the health care provider’s role in decision making. Questions about medical decisions made by patients without the presence of health care providers must be asked. Decisions to decline treatment options: not to undergo screening, not to seek prescription medication or to seek complementary or alternative medicine instead, or not to undergo diagnostic testing or surgery, may be decisions that are made based on information gathered from Internet research and that required no direct contact with a health care provider. (It is interesting to note that Couper and others demonstrated that Internet use was higher for those patients who did not take From the Sydney School of Public Health, University of Sydney, NSW, Australia.