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What’s Inside Research outside the lab Alternative therapies leading the way Trials N-of-1 registry Spirituality Severity of depression Helping vulnerable populations Evidence-based Vulnerable groups HIV Looking at the big picture Genetic research Sidebar: Understanding language impairment Sidebar: Help for overweight children Sidebar: Binge drinking and university students Research Views Responding to the reader Cellular construction Staying alive Stroke: brain attack The road to commercialization 2005-2006 Lionel McLeod Scholarship winner AHFMR announces $48 million for health research Reader Resources Research outside the lab Real life is complicated. That’s a given for all of us, but it can make certain types of research particularly tricky to conduct. Take Calgary psychologist Dr. Shervin Vakili’s research into binge drinking on campus. He is testing two types of intervention aimed at curbing this problem (see sidebar). Like any scientist, he has identified a population to study; he has placed his research subjects into groups according to the intervention they will receive; and he will evaluate whether the interventions have made a difference in behaviour. “The problem is that I can’t control the other variables during the two years this study will run,” says Dr. Vakili. “For example, there may be a crack-down on student drinking, a new law may be passed, or a new bar may open on campus. All these things would make it more difficult to determine the exact effects of the interventions. On the other hand, if I try to control the variables, then it’s not real life any more and the external validity of the results would be questioned. The value of this sort of research is in discovering what works in the real world. The trick is to set up your study in such a way as to control for as many of the real-life variables as possible while still maintaining a natural environment.” That’s one of the challenges of doing health research outside the lab, and it’s irresistible for many Alberta researchers. “This type of research is not easy, it’s time-consuming and expensive, and you have to follow people for a number of years before you get answers,” says Dr. Vakili. “But, to tell you the truth, I wouldn’t have it any other way. This is really exciting.” In the following article we take a look at eight AHFMR researchers who are working outside the lab on unusual research projects. Alternative therapies leading the way With more than 50,000 natural health products available in Canada, and widely varying claims about their effectiveness, it’s hard to know what to think about complementary and alternative-medicine (CAM) therapies. And doctors face the same dilemma as the rest of us. “Suppose I’m considering using melatonin (a hormone that is sold without a prescription in health-food stores and drug stores) to treat insomnia in a child with attention deficit disorder,” says Edmonton pediatrician and Heritage Population Health Investigator Dr. Sunita Vohra. “How do I know whether it’s effective or not? And if it is, what dose should I recommend?” Trials Doctors can refer to the results of randomized clinical trials—the gold standard for evaluating treatment efficacy—but those results are not necessarily applicable to the individual patient in front of them. Using Dr. Vohra’s example, while there may have been a clinical trial on the effectiveness of melatonin, it probably would have excluded participants with pre-existing conditions such as attention deficit disorder. So the results would not necessarily apply to her patient. A complicating factor for many complementary therapies is that randomized clinical trials have not yet been done. Dr. Vohra investigates another way to assess pediatric CAM therapies—an “N-of-1” trial (N being the letter normally used to designate a population of subjects taking part in an experiment). N-of-1 trials evaluate the effectiveness of a procedure or treatment in a single person, rather than a larger number of subjects. “An N-of-1 trial evaluates the individual’s potential for benefiting from a specific treatment,” explains Dr. Vohra, who has had training in pharmacology and epidemiology, as well as medicine. “Instead of putting the patient into a research model, as we do in a randomized controlled trial, we wrap the research methods around the patient. N-of-1 registry “We think N-of-1 is a particularly good approach to sifting through the huge number of CAM therapies, many of which are used for multiple conditions. It’s a way to find the therapies that appear to be helpful and are therefore worth additional attention.” Dr. Vohra heads the Complementary and Alternative Research and Education (CARE) program at the Stollery Children’s Hospital, Canada’s first academic program in pediatric integrative medicine (the combination of conventional and alternative treatments). With support from a number of partners, her team has embarked on an ambitious multi-phase project that aims to develop a rigorous approach to evaluating and pooling the results from N-of-1 trials. It will establish an N-of-1 registry at the Stollery Children’s Hospital, develop guidelines for the reporting of N-of-1 trials, and set up a pharmacy service to create natural health products for trials and test them for stability. “I believe we have to keep an open mind about CAM therapies,” she says. “There is so much we don’t know. By putting the needs of patients first, as is done in N-of-1 trials, we can learn.” Spirituality Sabine Moritz has been conducting research on CAM therapies since 1998. She is the research director of the Canadian Institute of Natural and Integrative Medicine (CINIM) in Calgary. One of her most recent projects is a study on the benefits of a program teaching spirituality to people suffering from depression. The impetus comes from the results of a previous study done by CINIM that examined the effect of a spirituality program and a mindful-meditation program on mood states. The people who took the spirituality program showed a 46% reduction in total mood disturbance, compared to a 26% reduction in the meditation group and an 11% reduction in the control group. A number of sub-scores were also analyzed, and the depression score was found to be particularly improved in the spirituality group. The finding immediately piqued the research team’s interest, says Ms. Moritz. “The results started us thinking: Could the spirituality program be used as a treatment for depression?” Severity of depression The new study is a randomized controlled trial to assess whether the spirituality program is effective in reducing the severity of depression (improving response rates, remission rates, and quality of life), and whether the efficacy is maintained long term. Participants are first assessed by a psychiatrist, and only those diagnosed with major depression may enter the trial. The spirituality teaching aims to improve mood and quality of life by presenting insights on meaning and purpose, connectedness and values. An eight-week, home-based program on CDs, it consists of eight 60- to 90-minute teaching sessions and a daily 15-minute visualization exercise. The program avoids focusing on any particular religion and is suitable for people with various cultural backgrounds. It was developed by psychiatrist Dr. Badri Rickhi, CINIM’s research chair. CINIM hopes to complete recruitment for the study by May 2006. (For details on how to participate in this study, go to www.cinim.org.) Ms. Moritz is eager to see the results. “Depression is often viewed as a strictly biochemical disorder. Antidepressants that treat the chemical imbalance can be effective, but they don’t work for everyone. There’s an aspect to depression that doesn’t respond to conventional therapy. If this aspect is addressed effectively, perhaps it can truly help people with depression change their lives.” Helping vulnerable populations In medical school Dr. John McLennan felt he was being pulled in two different directions: public health and child psychiatry. Rather than choose between them, he decided to do both—he took research training in public health and did a clinical specialty in child psychiatry. Now a Heritage Population Investigator at the University of Calgary, Dr. McLennan is putting together a research program that embraces both worlds. His interest is in the life trajectories of high-risk children and youth, and society’s efforts to improve those trajectories. He studies children with fetal alcohol syndrome and attention deficit hyperactivity disorder, malnourished children, and those who are in conflict with the law. “Children with developmental, mental-health, and social problems are in programs across many sectors—social services, the health system, the mental-health system, and the educational system. I want to know about the outcomes of these programs, what society is doing to improve outcomes, whether society is using evidence-based interventions to improve outcomes, and whether those attempts have been effective.” Sounds straightforward? It’s not. “It’s a mess to try to figure out what services are being offered and who is getting them,” says Dr. McLennan. “Record-keeping is not good. There’s no common database.” Evidence-based From examining projects in Canada, the Caribbean, and South America, he has discovered at least one common theme: for the majority of services in most sectors, providers are not using evidence-based interventions. Instead of effectiveness, the basis for choosing interventions tends to be theoretical understanding, preference of the service provider, and cost. “What this means is that children are receiving interventions, and we don’t know whether they’re effective, ineffective, or harmful,” says Dr. McLennan. “People forget that psychosocial interventions can have adverse effects just as medical treatments do. Interventions can do harm; it’s not simply a matter of ‘something is better than nothing’.” The other missing piece is measurement of outcomes. “It’s amazing that, although society is investing in helping high-risk children, outcome data are rarely collected. Although people talk about outcomes, they collect utilization data instead, which tell us how many people used the service, but not much else. This area is so grossly underevaluated.” Little by little, Dr. McLennan says, the message of evidence-based interventions is getting through. McMaster University in Ontario has been a leader in this area. The recent establishment of the Population Mental Health Research Program at Calgary’s Hotchkiss Brain Institute is the beginning of an Alberta-based cluster of expertise. “There’s a huge opportunity here. I believe that it’s better to know than not know about how effective services are. We can’t move forward if we just keep offering services without evaluating them.” Vulnerable groups In the Faculty of Social Work at the University of Calgary, another Population Health Investigator also studies vulnerable populations. Dr. Catherine Worthington’s research involves understanding the needs of vulnerable groups, such as street youth and Aboriginal youth, and designing services for them that will provide the best quality of care possible. For example, social services that are designed from a middle-class, nine-to-five perspective are probably not going to meet the needs of a young person who lives on the street. Access is likely to be a problem; the program environment might not be inviting; and the services themselves may not be what the street youth really needs. Dr. Worthington is particularly interested in groups that are vulnerable to HIV, the virus that causes AIDS. “In Canada, HIV has become a disease of vulnerable populations,” she notes. “The cultures and lifestyles of vulnerable populations have not been recognized by the mainstream. Although HIV is a huge risk in these communities, services are not designed for them. HIV “HIV is a virus that is transmitted via interactions between people. So the way to understand HIV in terms of prevention—and also use of treatment—is to look at the social environment. This means finding out how street youth interact among themselves, finding out what it’s like for an Aboriginal youth to go for HIV testing. You have to step out of your own shoes.” One of Dr. Worthington’s current studies investigates the services available to street youth in Calgary. Working with youth organizations, health-service agencies, and street kids themselves, her team developed a questionnaire to identify the factors that promote or impede the use of services relating to HIV and other health issues. The survey of 350 street-involved youths is now being followed up with 40 personal interviews to get in-depth information from young people in different social groups and sub-groups. “We’ve already done some of the interviews and I’ve read through the transcripts,” says Dr. Worthington. “These kids lead very complicated, challenging lives, but they also show great strength and resiliency. The problem is that services don’t necessarily fit with what they need.” Dr. Worthington’s work is called community-based research. “It’s a partnership between academia and the community. Community members and agencies get the information they need to assess services. As an academic, I get rich information about the vulnerable populations I’m interested in. It takes more time to design studies like this, because everyone needs to be at the table to ensure the study asks the questions they want answered. In the end, it’s a powerful collaboration with important results.” Looking at the big picture The genetic revolution has opened up many ethical, legal, and social concerns. The complexity of the questions in these areas, and the lack of clear answers, make the issues very difficult to study. That’s not a problem for Heritage Health Scholar Tim Caulfield, research director of the University of Alberta’s Health Law Institute and one of the leading researchers in health law in Canada. “The complexity is what makes this whole area so interesting for me,” he says. Professor Caulfield delves into the ethical, legal, and social issues of genetics and biotechnology through two major research initiatives: Genome Canada, the country’s primary funding and information resource relating to genomics and proteomics; and the Stem Cell Network (one of the Networks of Centres of Excellence) which investigates the therapeutic potential of stem cells for the treatment of diseases currently incurable by conventional approaches. One of his major interests is the commercialization of genetic research. Professor Caulfield is organizing an international workshop in Banff in May to discuss patenting issues. “There are all sorts of recommendations and concerns about patenting genetic material and technologies. We want to look at the available evidence and consider whether the concerns are justified. The workshop will be an excellent forum to determine the current situation. We’re also interested in finding out what kinds of evidence are needed. We plan to take information from the workshop, do some of the research, and fill in the gaps, particularly in the Canadian context.” Genetic research Another area of interest is in the way the media, private companies, and public agencies portray stem-cell and genetic research. “We have a project aimed at getting a sense of the manner in which genetic information is being presented to the public,” says Professor Caulfield. One of the aspects he studies is whether the documents take a genetic essentialist point of view, reducing the self to a molecular entity and equating human beings—in all their social, historical, and moral complexity—with their genes. As part of his Genome Canada research, Professor Caulfield directs a project that will bring together all the evidence on resource-allocation decisions related to new genetic technologies. His team examines the process of deciding which of these technologies should be funded. Why bother? It’s all about public trust, says Professor Caulfield. “Huge amounts of public money are being invested in genetics and biotechnology. If we’re going to do research in these areas, we must ensure that the research is done in a way that maintains public trust.” Dr. Sunita Vohra is an AHFMR Population Health Investigator and associate professor in the Department of Pediatrics with a cross-appointment in the Department of Public Health Sciences at the University of Alberta. She is also director of the Complementary and Alternative Research and Education (CARE) program at the Stollery Children’s Hospital and director of the Canadian Pediatric CAM Network. She receives funding from the Canadian Institutes of Health Research (CIHR) and the Institute of Health Economics. Sabine Moritz is director for research at the Canadian Institute of Natural and Integrative Medicine in Calgary. Her study on spirituality and depression is funded by the Health Research Fund, administered by AHFMR on behalf of Alberta Health and Wellness. Dr. John McLennan is an AHFMR Population Health Investigator, a child psychiatrist, and an assistant professor in the departments of Pediatrics, Community Health Sciences, and Psychiatry at the University of Calgary. He receives funding from CIHR; the Institute of Health Economics; the Alberta Children’s Hospital Foundation; the Alberta Centre for Child, Family and Community Research; and the Canadian International Development Agency. Dr. Catherine Worthington is an AHFMR Population Health Investigator and assistant professor in the Faculty of Social Work at the University of Calgary. She has received funding from SSHRC (Social Sciences and Humanities Research Council of Canada), CIHR, The Ontario HIV Treatment Network, and the Canadian Working Group on HIV and Rehabilitation. Professor Timothy Caulfield is a full professor in the Faculty of Law and the Faculty of Medicine and Dentistry, and research director of the University of Alberta’s Health Law Institute. An AHFMR Health Scholar and Canada Research Chair in Health Law and Policy, his research is supported by Genome Canada, the Stem Cell Network, CIHR, SSHRC, the Advanced Food and Materials Network, and the Alberta Law Foundation. Selected publications Moritz S, Quan H, Rickhi B, Liu M, Angen M, Vintila R, Sawa R, Stuart H, Soriano J, Toews J. A home-based spirituality education programme decreases emotional distress and increases quality of life—a randomized controlled trial. Alternative Therapies in Health and Medicine 2006. In press 2006. McLennan JD, MacMillan HL, Jamieson E. Canada’s programs to prevent mental health problems in children: the research-practice gap. Canadian Medical Association Journal 2004 Oct 26;171(9):1069-1071. Worthington C, Myers T. Desired elements of HIV testing services: test recipient perspectives. AIDS Patient Care and STDs 2002;16(11):537-548. Caulfield T, Brownsword R. Human dignity: a guide to policy making in the biotechnology era? Nature reviews, Genetics 2006 Jan;7(1):72-76. Sidebar: Understanding language impairment Language impairment can have a profound effect on a child’s life. For example, a developmental language disorder called Specific Language Impairment (SLI) makes it very difficult to learn to read, and generally hampers a child’s academic success. Early intervention can help; and schools now focus on diagnosing children with SLI. But our desire to help may actually be hurting some students. Children who are learning English as a second language (ESL) tend to make mistakes similar to those that monolingual children with SLI make. For example, both ESL children and monolingual children with SLI might say “he go over there” instead of “he goes over there”. “As a result of these kinds of errors, children learning ESL can get caught in the net of being falsely labelled as language- and learning-impaired,” says Heritage Population Health Investigator Dr. Johanne Paradis, a linguistics professor at the University of Alberta. “The problem stems from the fact that our assessment tools are normed to a monolingual population. There is virtually nothing for children whose native language is not English.” The long-term objective of Dr. Paradis is to develop such tools. Her first step was to investigate the typical errors made by ESL children, and compare them to ones made by children with SLI. The research team followed children learning ESL who came from a variety of language backgrounds, including Arabic, Spanish, and Mandarin. For two and a half years, they were regularly given tests to evaluate comprehension and production of English—the kind of tests used to detect language impairment. “The results are a good-news bad-news story,” says Dr. Paradis. “The bad news is that there is a huge amount of overlap in the kinds of errors children make. What’s worse is that, even after more than two years, the children learning ESL still scored as language-impaired. This isn’t a temporary thing; it takes them a long time to perform as a native speaker does. The good news is that there are some small differences in the way children learning ESL make these errors.” To follow this up, Dr. Paradis is hoping to start a large-scale study that would recruit and test hundreds of children learning ESL—children from different language backgrounds, of different ages, and with different levels of exposure to English. “There were only 24 children in my first study. Because individual variation is so high, we need large numbers to develop norms for children learning ESL. In this way I hope to turn an academically interesting finding into a clinically relevant tool.” Dr. Johanne Paradis is an AHFMR Population Health Investigator and associate professor in the Department of Linguistics, part of the Faculty of Arts at the University of Alberta. Her research is supported by the Social Sciences and Humanities Research Council of Canada. Sidebar: Help for overweight children National surveys have revealed that the number of overweight youth in Canada has increased dramatically over the past couple of decades. Currently in Alberta, about one in four children is overweight. “Right now, children are facing very real health risks from being overweight,” says Heritage Population Health Investigator Dr. Geoff Ball, a registered dietitian who is one of Canada’s leading specialists in pediatric obesity. “Currently there’s precious little to offer families. There are programs that are simply modified versions of adult interventions; but the design, delivery, and evaluation of these programs often doesn’t fit a pediatric model.” Dr. Ball notes that while placing a child on a 1200-calorie diet and prescribing a structured exercise plan can cause weight loss, there is limited sustainability over the long term. “With traditional weight-loss strategies, weight loss is usually the indicator of success. We are developing, delivering, and evaluating novel programs that target a host of quantitative and qualitative outcomes to evaluate health improvements in families and the effectiveness of our team in health services delivery. We want to do better for our children and families, and our practice-based research clinic will facilitate ongoing program evaluation.” Dr. Ball heads Capital Health’s Pediatric Centre for Weight and Health (PCWH) at the Stollery Children’s Hospital in Edmonton, the first centre of its kind in Canada to fully integrate weight-management care and research in pediatric obesity. One of the centre’s current projects is the development and evaluation of a new weight-management program for overweight 13- to 17-year-olds. The HIP (Healthy Initiatives Program) for Youth intervention addresses weight-related issues by combining cognitive behavioural therapy and motivational interviewing strategies. Teens attend counselling sessions over 20 weeks; support and follow-up are provided through the PCWH for an additional two years. Counselling involves individual coaching from “HIPmates”, roles taken on by the PCWH dietitian, exercise specialist, and nurse. Not only are they experts on lifestyle behavioural counselling and weight-related issues; HIPmates are specially trained in communicating with teens and their families. Capitalizing on the emerging independence of teenagers, the one-on-one sessions with HIPmates aim to understand the causes of the teen’s weight and explore strategies to support healthy behavioural changes. Outcomes for participants in the HIP for Youth program will be compared to those for the young people who participate in the Youth Lifestyle Program—which takes a more traditional weight-loss approach—and those for a control group (teens on the wait list). Enrolment in the study began in January 2006 and will continue over the next two years. A new, family-centred program for overweight 8- to 12-year-olds and their parents will begin in the spring. “The PCWH offers a great opportunity for treatment and research, but we also have an important role to play by increasing pediatric weight-management capacity among students, health professionals, and researchers,” Dr. Ball adds. “By increasing the knowledge and skill base, we can help a far greater number of people than we will ever see through our clinic doors.” Dr. Geoff Ball is an assistant professor in the Department of Pediatrics at the University of Alberta, and director of Capital Health’s Pediatric Centre for Weight and Health (PCWH) at the Stollery Children’s Hospital. An AHFMR Population Health Investigator, he receives support for his research from the Canadian Institutes of Health Research (CIHR) and the Stollery Children’s Hospital Foundation. Selected publication Ball GDC, Huang TT-K, Gower BA, Cruz ML, Shaibi GQ, Weigensberg MJ, Goran MI. Longitudinal changes in insulin sensitivity, insulin secretion, and b-cell function during puberty. Journal of Pediatrics 2006 Jan;148(1):16-22. Sidebar: Binge drinking and university students Binge drinking is the number one health hazard for North American university and college students because of its range of negative consequences—lower marks, run-ins with the law, unwanted or unplanned sex, to name a few. Interventions aimed at bringing it under control have not succeeded in lowering binge-drinking rates. The University of Calgary’s Dr. Shervin Vakili leads a research project to test new techniques to curb binge drinking. The first phase involved an online survey to gather information about student drinking at the University of Calgary. Approximately 2,200 students completed the questionnaire. Now students are being recruited into the second phase of the study, which will test two interventions. The first intervention is social norming. Based on the finding that university students consistently overestimate how much their peers drink and believe that their peers are more accepting of drinking than they actually are, social norming aims to correct students’ misconceptions by giving them information and statistics about drinking behaviour. “The idea is that people increase their drinking to fit the norm,” explains Dr. Vakili. “Once you tell them what the norm really is, this should alleviate some of the social pressure and hopefully reduce binge-drinking.” The other intervention adds a personalized feedback message, which tells the individual how much he or she drinks as compared to others (based on the survey data collected in phase one). Both social norming and personalized feedback have shown promise in work with similar groups in the past. All of the information will be distributed to study participants on specially designed postcards. Drinking behaviour and attitudes will be re-assessed at the end of one year and again at the end of the second year. Dr. Shervin Vakili is an adjunct assistant professor in the Department of Psychology at the University of Calgary, and a psychologist at the Calgary Health Region’s Addiction Centre. His study on binge drinking is funded by the Health Research Fund, administered by AHFMR on behalf of Alberta Health and Wellness. Back to Top