The AI Future of Emergency Medicine.

In the coming years, artificial intelligence (AI) and machine learning will likely give rise to profound changes in the field of emergency medicine, and medicine more broadly. This article discusses these anticipated changes in terms of 3 overlapping yet distinct stages of AI development. It reviews some fundamental concepts in AI and explores their relation to clinical practice, with a focus on emergency medicine. In addition, it describes some of the applications of AI in disease diagnosis, prognosis, and treatment, as well as some of the practical issues that they raise, the barriers to their implementation, and some of the legal and regulatory challenges they create.

Are family medicine residents trained to counsel patients on physical activity? The Canadian experience and a call to action.

Physical inactivity is a leading risk factor for non-communicable diseases (NCDs) and early mortality. Family physicians have an important role in providing physical activity counselling to patients to help prevent and treat NCDs. Lack of training on physical activity counselling is a barrier in undergraduate medical education, yet little is known regarding physical activity teaching in postgraduate family medicine residency. We assessed the provision, content and future direction of physical activity teaching in Canadian postgraduate family medicine residency programs to address this data gap. Fewer than half of Canadian Family Medicine Residency Programme directors reported providing structured physical activity counselling education to residents. Most directors reported no imminent plans to change the content or amount of teaching. These results reflect significant gaps between the recommendations of WHO, which calls on doctors to prescribe physical activity, and the current curricular content and needs of family medicine residents. Almost all directors agreed that online educational resources developed to assist residents in physical activity prescription would be beneficial. By describing the provision, content and future direction of physical activity training in family medicine, physicians and medical educators can develop competencies and resources to meet this need. When we equip our future physicians with the necessary tools, we can improve patient outcomes and do our part to reduce the global epidemic of physical inactivity and chronic disease.

Older adults and social prescribing experience, outcomes, and processes: a meta-aggregation systematic review.

OBJECTIVE: Social prescribing is a complex care model, which aims to address unmet non-medical needs and connect people to community resources. The purpose of this systematic review was to synthesize available evidence from qualitative methods (e.g. interviews or focus groups) on experience, outcomes, and processes for social prescribing and older adults (from the person or provider level). STUDY DESIGN: This was a systematic review using the Joanna Brigg's meta-aggregative approach. METHODS: We searched multiple online databases for peer-reviewed studies, which included older adults aged ≥60 years (group mean age) and social prescribing experience, outcomes, or processes. We included all qualitative or mixed methods designs from all years and languages. Date of the last primary search was March 24, 2022. Two authors used online software to conduct the screening independently and then decided on the final list of included studies via notes and online discussion. RESULTS: We screened 376 citations (after duplicates) and included eight publications. There were 197 older adult participants (59% women), and many people were living with chronic health conditions. Few details were provided for participants' ethnicity, education, and related factors. We created five synthesized findings related to (1) the approach of social prescribing; implementation factors such as (2) relationships, (3) behavior change strategies, and (4) the environment; and (5) older adults' perceived health and psychosocial outcomes. CONCLUSIONS: Despite the limited number of available studies, data provide an overview of people and processes involved with social prescribing, identified research and practice gaps, and possible next steps for implementing and evaluating social prescribing for older adults in primary care.

Adding team-based financial incentives to the Carrot Rewards physical activity app increases daily step count on a population scale: a 24-week matched case control study.

BACKGROUND: Mobile health applications (mHealth apps) targeting physical inactivity have increased in popularity yet are usually limited by low engagement. This study examined the impact of adding team-based incentives (Step Together Challenges, STCs) to an existing mHealth app (Carrot Rewards) that rewarded individual physical activity achievements. METHODS: A 24-week quasi-experimental study (retrospective matched pairs design) was conducted in three Canadian provinces (pre-intervention: weeks 1-12; intervention: weeks 13-24). Participants who used Carrot Rewards and STCs (experimental group) were matched with those who used Carrot Rewards only (controls) on age, gender, province and baseline mean daily step count (±500 steps/d). Carrot Rewards users earned individual-level incentives (worth $0.04 CAD) each day they reached a personalized daily step goal. With a single partner, STC users could earn team incentives ($0.40 CAD) for collaboratively reaching individual daily step goals 10 times in seven days (e.g., Partner A completes four goals and Partner B completes six goals in a week). RESULTS: The main analysis included 61,170 users (mean age = 32 yrs.; % female = 64). Controlling for pre-intervention mean daily step count, a significant difference in intervention mean daily step count favoured the experimental group (p < 0.0001; ηp2 = 0.024). The estimated marginal mean group difference was 537 steps per day, or 3759 steps per week (about 40 walking min/wk). Linear regression suggested a dose-response relationship between the number of STCs completed (app engagement) and intervention mean daily step count (adjusted R2 = 0.699) with each new STC corresponding to approximately 200 more steps per day. CONCLUSION: Despite an explosion of physical activity app interest, low engagement leading to small or no effects remains an industry hallmark. In this paper, we found that adding modest team-based incentives to the Carrot Rewards app increased mean daily step count, and importantly, app engagement moderated this effect. Others should consider novel small-teams based approaches to boost engagement and effects.

Heart failure management insights from primary care physicians and allied health care providers in Southwestern Ontario.

BACKGROUND: It remains to be determined whether collaborative strategies to improve and sustain overall health in patients with heart failure (HF) are currently being adopted by health care professionals. We surveyed primary care physicians, nurses and allied health care professionals in Southwestern Ontario regarding how they currently manage HF patients and how they perceive limitations, barriers and challenges in achieving optimal management in these patients. METHODS: We developed an online survey based on field expertise and a review of pertinent literature in HF management. We analyzed quantitative data collected via an online questionnaire powered by Qualtrics®. The survey included 87 items, including multiple choice and free text questions. We collected participant demographic and educational background, and information relating to general clinical practice and specific to HF management. The survey was 25 min long and was administered in October and November of 2018. RESULTS: We included 118 health care professionals from network lists of affiliated physicians and clinics of the department of Family Medicine at Western University; 88.1% (n = 104) were physicians while 11.9% (n = 14) were identified as other health care professionals. Two-thirds of our respondents were females (n = 72) and nearly one-third were males (n = 38). The survey included mostly family physicians (n = 74) and family medicine residents (n = 25). Most respondents indicated co-managing their HF patients with other health care professionals, including cardiologists and internists. The vast majority of respondents reported preferring to manage their HF patients as part of a team rather than alone. As well, the majority respondents (n = 47) indicated being satisfied with the way they currently manage their HF patients; however, some indicated that practice set up and communication resources, followed by experience and education relating to HF guidelines, current drug therapy and medical management were important barriers to optimal management of HF patients. CONCLUSIONS: Most respondents indicated HF management was satisfactory, however, a minority did identify some areas for improvement (communication systems, work more collaborative as a team, education resources and access to specialists). Future research should consider these factors in developing strategies to enhance primary care involvement in co-management of HF patients, within collaborative and multidisciplinary systems of care.

Are we missing the target? Are we aiming too low? What are the aerobic exercise prescriptions and their effects on markers of cardiovascular health and systemic inflammation in patients with knee osteoarthritis? A systematic review and meta-analysis.

OBJECTIVES: We systemically reviewed published studies that evaluated aerobic exercise interventions in patients with knee osteoarthritis (OA) to: (1) report the frequency, intensity, type and time (FITT) of exercise prescriptions and (2) quantify the changes in markers of cardiovascular health and systemic inflammation. DATA SOURCES: PubMed, CINAHL, Scopus; inception to January 2019. ELIGIBILITY CRITERIA: Randomised clinical trials (RCT), cohort studies, case series. DESIGN: We summarised exercise prescriptions for all studies and calculated effect sizes with 95% CIs for between-group (RCTs that compared exercise and control groups) and within-group (pre-post exercise) differences in aerobic capacity (VO2), heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and inflammatory markers (interleukin-6 (IL-6), tumour necrosis factor-alpha). We pooled results where possible using random effects models. RESULTS: Interventions from 49 studies were summarised; 8% (4/49) met all FITT guidelines; 16% (8/49) met all or most FITT guidelines. Fourteen studies (10 RCTs) reported at least one marker of cardiovascular health or systemic inflammation. Mean differences (95% CI) indicated a small to moderate increase in VO2 (0.84 mL/min/kg; 95% CI 0.37 to 1.31), decrease in HR (-3.56 beats per minute; 95% CI -5.60 to -1.52) and DBP (-4.10 mm Hg; 95% CI -4.82 to -3.38) and no change in SBP (-0.36 mm Hg; 95% CI -3.88 to 3.16) and IL-6 (0.37 pg/mL; 95% CI -0.11 to 0.85). Within-group differences were also small to moderate. CONCLUSIONS: In studies of aerobic exercise in patients with knee OA, very few interventions met guideline-recommended dose; there were small to moderate changes in markers of cardiovascular health and no decrease in markers of systemic inflammation. These findings question whether aerobic exercise is being used to its full potential in patients with knee OA. PROSPERO REGISTRATION NUMBER: CRD42018087859.

A Scoping Review of Multiple-modality Exercise and Cognition in Older Adults: Limitations and Future Directions.

The effects of multiple-modality exercise (MME) on brain health warrants further elucidation. Our objectives were to report and discuss the current evidence regarding the influence of MME on cognition and neuroimaging outcomes in older adults without dementia. We searched the literature for studies investigating the effects of MME on measures of cognition, brain structure, and function in individuals 55 years or older without dementia. We include 33 eligible studies. Our findings suggested that MME improved global cognition, executive functioning, processing speed, and memory. MME also improved white and gray matter and hippocampal volumes. These findings were evident largely when compared with no-treatment control groups but not when compared with active (e.g., health education) or competing treatment groups (e.g., cognitive training). MME may improve brain health in older adults without dementia; however, because of possible confounding factors, more research is warranted.

The clinical and economic burden among caregivers of patients with Alzheimer's disease in Canada.

OBJECTIVE: To estimate the clinical and direct medical economic burden among Alzheimer disease (AD) caregivers using real-world, longitudinal patient-level data in Canada. METHODS/DESIGN: This retrospective observational study assessed the clinical and direct medical economic burden among individuals who cohabitate with AD patients ("AD caregiver cohort") compared with older adults who were cohabiting with another adult without dementia ("comparison cohort") using real-world data from the Southwestern Ontario database, a representative Canadian electronic health record (EHR) longitudinal EHR. RESULTS: The AD caregiver cohort (n = 2749; mild AD: n = 2254, moderate AD: n = 302, and severe AD, n = 193) had a similar or higher level of clinical and economic burden than the comparison cohort (n = 12 152). The overall AD cohort and caregivers of patients with mild AD had a similar clinical burden to the comparison cohort. Those caregiving for more severely affected AD patients had an increased risk of comorbidities and required more medication, physician attention, and hospital encounters compared with caregivers of less severe AD patients and the comparison cohort. Mean annual costs were higher among the AD caregiver cohort than the comparison cohort, and those caregiving for moderate and severe AD patients incurred the highest costs. Overall mortality was higher in the AD caregiver cohort compared with the comparison cohort. CONCLUSIONS: Caregivers of patients with mild AD had a similar clinical and direct economic burden to older adults who were not dementia caregivers, whereas the burden among caregivers of moderate and severe AD patients was much greater.

Coaching and/or education intervention for parents with overweight/obesity and their children: study protocol of a single-centre randomized controlled trial.

BACKGROUND: In Canada, a majority of children and adults are insufficiently active for health gains, and about one in seven children and over 20% of adults are overweight or obese. Overweight and obesity are risk factors for many chronic diseases in both adults and children and can result in lower quality and quantity of life. Children whose parents are overweight or obese are more likely to become overweight themselves. Thus, parent/child interventions are important for reducing obesity and promoting long-term healthy weights among members of the family unit. Programs using Co-Active coaching have resulted in positive behaviour changes among adults with overweight/obesity; however, little research has explored the effects of Co-Active coaching on parents, and the consequent impact on the family unit (i.e. all parents and children in the same household). This protocol paper provides a detailed methodological account of a coaching-based program targeting parent and child dyads, in hopes of enhancing health behaviours within the family unit. METHODS: Using a randomized controlled trial design, the researchers aim to identify the impact of coaching plus education (intervention) compared to education only (control) on parents with overweight/obesity and their children (ages 2.5-10, of any weight). A total of 50 dyads are being recruited and randomly assigned using a 1:1 ratio into the control or intervention group. The control group receive 6 webinar-based education sessions focused on physical activity and nutrition. The intervention group receive the same education sessions and nine, 20-min telephone-based sessions with a certified coach. Coaching and health education sessions are conducted with the parent/guardian of the dyad. This paper provides a detailed methodological account of this program. DISCUSSION: The expected findings from this research will advance coaching literature, research, and practice on this topic by determining whether coaching and education are more effective than education alone at producing behaviour changes among a family unit. If proven effective, this approach may be applied more broadly through public health interventionists to parent and child populations in hopes of affecting change with both individuals and their families. TRIAL REGISTRATION: ISRCTN ISRCTN69091372 . Retrospectively registered 24 September 2018.

Identifying musculoskeletal conditions in electronic medical records: a prevalence and validation study using the Deliver Primary Healthcare Information (DELPHI) database.

BACKGROUND: Musculoskeletal (MSK) conditions are a common presentation in primary care. This study sought to determine the prevalence of MSK conditions in primary care in Ontario and to validate the extent to which health administrative date billing codes accurately represent MSK diagnoses. METHODS: De-identified electronic medical records (EMR) from the DELPHI database in southwestern Ontario, which contains 2493 patients (55.6% female, mean age 50.3 years (SD = 22.2)) and 21,964 encounters (July 1, 2006-June 30, 2010) were used for the analyses. Outcomes included: validation measures of agreement between International Classification of Diseases (ICD-9) diagnostic codes (health administrative data) and International Classification of Primary Care (ICPC) diagnoses defined as the reference standard, time to first ICD-9 code, prevalence, and healthcare utilization. RESULTS: There were 2940 true positive MSK encounters with primary care practitioners for 998 patients. Performance of the ICD-9 diagnostic codes included sensitivity = 76.5%, specificity = 95.2%, PPV = 94.6%, and NPV = 78.7%, compared to the ICPC reference standard. The majority of 998 patients were coded with both an ICPC and ICD-9 MSK code at their first or second encounter (67.4%). However, 23.5% of patients with the ICPC reference standard MSK were never coded with ICD-9. Four-year prevalence of MSK was 52.3% and varied by age (4.5% 0-17 years, 20.1% 18-44, 42.7% 45-64, and 32.7% 65+). Patients at MSK encounters had a higher number of: investigations (17.9% compared to 9.1%, p < .0001); referrals (17.6% compared to 14.3%, p < .0001); and prescriptions for opioids (17.2% compared to 5.3%, p < .0001). CONCLUSIONS: This study determined the prevalence of musculoskeletal conditions in primary care in Ontario using a reference standard definition. The study highlighted the value of using primary care ICPC codes to validate a definition for musculoskeletal conditions. Health administrative data can be used to ascertain the presence of musculoskeletal conditions; however, ICD-9 codes may underrepresent the prevalence of MSK conditions.

Lessons Learned in the Implementation of HealtheSteps: An Evidence-Based Healthy Lifestyle Program.

HealtheSteps is a pragmatic, evidence-based lifestyle prescription program aimed at reducing the rates of chronic disease, in particular, type 2 diabetes. A process evaluation was completed to assess the feasibility of the implementation of HealtheSteps in primary care and community-based settings across Canada. Key informant interviews (program providers and participants) were conducted to identify facilitators and barriers to implementation and opportunities for future program adaptation and improvement. Forty-three interviews were conducted across five regions in Canada (15 sites ranging from remote, rural, suburban, and urban). Transcripts were analyzed using a qualitative naturalistic inquiry approach with several facilitating factors identified: pragmatic program design, in-line goals with sites' mandates, and access to ongoing support. Barriers were related to administrative challenges such as booking space, personnel changeovers, and scheduling participants. Findings from this analysis revealed insights on program delivery, design, and importance of site champions. Key lessons learned focused on two areas: infrastructure support and program implementation. The application of these learnings from the HealtheSteps program may inform the development of strategies that can optimize program adaptation and support while reducing real and perceived barriers experienced, thus increasing the success of translation of the evidence-based diabetes program to different points of care.

Caregivers: Do They Make a Difference to Patient Recovery in Subacute Stroke?

OBJECTIVE: To evaluate the relationship between caregiver nature and availability, and rehabilitation outcomes in subacute stroke. DESIGN: Retrospective cohort study. SETTING: Four community rehabilitation hospitals. PARTICIPANTS: Patients with subacute, first-time stroke (N=4042; 48.5% men; mean age ± SD, 70.12±10.4y; 51.5% women; mean age ± SD, 72.54 ±10.0y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rehabilitation effectiveness, defined as the percentage of potential improvement eventually achieved with rehabilitation; and rehabilitation efficiency, defined as the rate of functional improvement during rehabilitation. RESULTS: In our cohort, 96.7% had available caregiver(s), of which 42.0% were primarily supported by foreign domestic workers (FDWs), 25.9% by spouses, 19.3% by first-degree relatives, 7.8% by other relatives, and 5.1% by other caregivers. Using quantile regression, we found that having a caregiver was independently associated with rehabilitation efficiency (ß=-3.83; 95% confidence interval [CI], -6.99 to -0.66; P=.018). The relationship between caregiver availability and rehabilitation effectiveness was modified by patient sex in that the negative association was significantly greater in men (ß=-22.81; 95% CI, -32.70 to -12.94; P<.001) than women (ß=-5.64; 95% CI, -14.72 to 3.44; P=.223). Having a FDW as a caregiver compared with a spousal caregiver was negatively associated with rehabilitation effectiveness (ß=-3.95; 95% CI, -6.94 to -0.95; P=.01) and rehabilitation efficiency (ß=-1.83; 95% CI, -3.14 to -0.53; P=.006). The number of potential caregivers was only significantly associated with rehabilitation effectiveness at the bivariate level (P=.006). CONCLUSIONS: Caregiver identity, and possibly availability, appears to negatively affect rehabilitation outcomes in subacute stroke. A better understanding of these relationships has potential implications on clinical practice and policy directions.

Optimization of the Hockey Fans in Training (Hockey FIT) weight loss and healthy lifestyle program for male hockey fans.

BACKGROUND: The health outcomes of men continue to be poorer than women globally. Challenges in addressing this problem include difficulties engaging men in weight loss programs as they tend to view these programs as contrary to the masculine narrative of independence and self-reliance. Researchers have been turning towards sports fans to engage men in health promotion programs as sports fans are typically male, and tend to have poor health habits. METHODS: Developed from the highly successful gender-sensitized Football Fans in Training program, Hockey Fans in Training (Hockey FIT) recruited 80 male hockey fans of the London Knights and Sarnia Sting who were overweight or obese into a weekly, 90-minute classroom education and group exercise program held over 12 weeks; a 40-week minimally-supported phase followed. A process evaluation of the Hockey FIT program was completed alongside a pragmatic randomized controlled trial and outcome evaluation in order to fully explore the acceptability of the Hockey FIT program from the perspectives of coaches delivering and participants engaged in the program. Data sources included attendance records, participant focus groups, coach interviews, assessment of fidelity (program observations and post-session coach reflections), and 12-month participant interviews. RESULTS: Coaches enjoyed delivering the program and found it simple to deliver. Men valued being among others of similar body shape and similar weight loss goals, and found the knowledge they gained through the program helped them to make and maintain health behaviour changes. Suggested improvements include having more hockey-related information and activities, greater flexibility with timing of program delivery, and greater promotion of technology support tools. CONCLUSIONS: We confirmed Hockey FIT was an acceptable "gender-sensitized" health promotion program for male hockey fans who were overweight or obese. Minor changes were required for optimization, which will be evaluated in a future definitive trial. TRIAL REGISTRATION: NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

HealtheSteps™ Study Protocol: a pragmatic randomized controlled trial promoting active living and healthy lifestyles in at-risk Canadian adults delivered in primary care and community-based clinics.

BACKGROUND: Physical inactivity is one of the leading causes of chronic disease in Canadian adults. With less than 50% of Canadian adults reaching the recommended amount of daily physical activity, there is an urgent need for effective programs targeting this risk factor. HealtheSteps™ is a healthy lifestyle prescription program, developed from an extensive research base to address risk factors for chronic disease such as physical inactivity, sedentary behaviour and poor eating habits. HealtheSteps™ participants are provided with in-person lifestyle coaching and access to eHealth technologies delivered in community-based primary care clinics and health care organizations. METHOD/DESIGN: To determine the effectiveness of Healthesteps™, we will conduct a 6-month pragmatic randomized controlled trial with integrated process and economic evaluations of HealtheSteps™ in 5 clinic settings in Southwestern Ontario. 110 participants will be individually randomized (1:1; stratified by site) to either the intervention (HealtheSteps™ program) or comparator (Wait-list control). There are 3 phases of the HealtheSteps™ program, lasting 6 months each. The active phase consists of bi-monthly in-person coaching with access to a full suite of eHealth technology supports. During the maintenance phase I, the in-person coaching will be removed, but participants will still have access to the full suite of eHealth technology supports. In the final stage, maintenance phase II, access to the full suite of eHealth technology supports is removed and participants only have access to publicly available resources and tools. DISCUSSION: This trial aims to determine the effectiveness of the program in increasing physical activity levels and improving other health behaviours and indicators, the acceptability of the HealtheSteps™ program, and the direct cost for each person participating in the program as well as the costs associated with delivering the program at the different community sites. These results will inform future optimization and scaling up of the program into additional community-based primary care sites. TRIAL REGISTRATION: NCT02413385 (Clinicaltrials.gov). Date Registered: April 6, 2015.

Who Uses Mobile Phone Health Apps and Does Use Matter? A Secondary Data Analytics Approach.

BACKGROUND: Mobile phone use and the adoption of healthy lifestyle software apps ("health apps") are rapidly proliferating. There is limited information on the users of health apps in terms of their social demographic and health characteristics, intentions to change, and actual health behaviors. OBJECTIVE: The objectives of our study were to (1) to describe the sociodemographic characteristics associated with health app use in a recent US nationally representative sample; (2) to assess the attitudinal and behavioral predictors of the use of health apps for health promotion; and (3) to examine the association between the use of health-related apps and meeting the recommended guidelines for fruit and vegetable intake and physical activity. METHODS: Data on users of mobile devices and health apps were analyzed from the National Cancer Institute's 2015 Health Information National Trends Survey (HINTS), which was designed to provide nationally representative estimates for health information in the United States and is publicly available on the Internet. We used multivariable logistic regression models to assess sociodemographic predictors of mobile device and health app use and examine the associations between app use, intentions to change behavior, and actual behavioral change for fruit and vegetable consumption, physical activity, and weight loss. RESULTS: From the 3677 total HINTS respondents, older individuals (45-64 years, odds ratio, OR 0.56, 95% CI 0.47-68; 65+ years, OR 0.19, 95% CI 0.14-0.24), males (OR 0.80, 95% CI 0.66-0.94), and having degree (OR 2.83, 95% CI 2.18-3.70) or less than high school education (OR 0.43, 95% CI 0.24-0.72) were all significantly associated with a reduced likelihood of having adopted health apps. Similarly, both age and education were significant variables for predicting whether a person had adopted a mobile device, especially if that person was a college graduate (OR 3.30). Individuals with apps were significantly more likely to report intentions to improve fruit (63.8% with apps vs 58.5% without apps, P=.01) and vegetable (74.9% vs 64.3%, P<.01) consumption, physical activity (83.0% vs 65.4%, P<.01), and weight loss (83.4% vs 71.8%, P<.01). Individuals with apps were also more likely to meet recommendations for physical activity compared with those without a device or health apps (56.2% with apps vs 47.8% without apps, P<.01). CONCLUSIONS: The main users of health apps were individuals who were younger, had more education, reported excellent health, and had a higher income. Although differences persist for gender, age, and educational attainment, many individual sociodemographic factors are becoming less potent in influencing engagement with mobile devices and health app use. App use was associated with intentions to change diet and physical activity and meeting physical activity recommendations.

Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol.

BACKGROUND: Dementia is associated with cognitive and functional deficits, and poses a significant personal, societal, and economic burden. Directing interventions towards older adults with self-reported cognitive complaints may provide the greatest impact on dementia incidence and prevalence. Risk factors for cognitive and functional deficits are multifactorial in nature; many are cardiovascular disease risk factors and are lifestyle-mediated. Evidence suggests that multiple-modality exercise programs can provide cognitive and functional benefits that extend beyond what can be achieved from cognitive, aerobic, or resistance training alone, and preliminary evidence suggests that novel mind-motor interventions (i.e., Square Stepping Exercise; SSE) can benefit cognition and functional fitness. Nevertheless, it remains unclear whether multiple-modality exercise combined with mind-motor interventions can benefit diverse cognitive and functional outcomes in older adults with cognitive complaints. METHODS/DESIGN: The Multiple-Modality, Mind-Motor (M4) study is a randomized controlled trial investigating the cognitive and functional impact of combined physical and cognitive training among community-dwelling adults with self-reported cognitive complaints who are 55 years of age or older. Participants are randomized to a Multiple-Modality and Mind-Motor (M4) intervention group or a Multiple-Modality (M2) comparison group. Participants exercise for 60 minutes/day, 3-days/week for 24 weeks and are assessed at baseline, 24 weeks and 52 weeks. The primary outcome is global cognitive function at 24 weeks, derived from the Cambridge Brain Sciences computerized cognitive battery. Secondary outcomes are: i) global cognitive function at 52 weeks; ii) domain-specific cognitive function at 24 and 52 weeks; iii) mobility (gait characteristics under single and dual-task conditions and balance); and 3) vascular health (blood pressure and carotid arterial measurements). We will analyze data based on an intent-to-treat approach, using mixed models for repeated measurements. DISCUSSION: The design features of the M4 trial and the methods included to address previous limitations within cognitive and exercise research will be discussed. Results from the M4 trial will provide evidence of combined multiple-modality and cognitive training among older adults with self-reported cognitive complaints on cognitive, mobility-related and vascular outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02136368.

Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans.

BACKGROUND: Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. METHODS: Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation. We conducted a two-arm pilot pragmatic randomized controlled trial (pRCT) whereby 80 overweight/obese male hockey fans (35-65 years; body-mass index ≥28 kg/m2) were recruited through their connection to two junior A hockey teams (London and Sarnia, ON) and randomized to Intervention (Hockey FIT) or Comparator (Wait-List Control). Hockey FIT includes a 12-week Active Phase (classroom instruction and exercise sessions delivered weekly by trained coaches) and a 40-week Maintenance Phase. Data collected at baseline and 12 weeks (both groups), and 12 months (Intervention only), will inform evaluation of the potential of Hockey FIT to help men lose weight and improve other health outcomes. Feasibility and acceptability will be assessed using data from self-reports at screening and baseline, program fidelity (program observations and coach reflections), participant focus group discussions, coach interviews, as well as program questionnaires and interviews with participants. This information will be analyzed to inform program optimization. DISCUSSION: Hockey FIT is a gender-sensitive program designed to engage overweight/obese male hockey fans to improve physical activity and healthy eating choices, thereby leading to weight loss and other positive changes in health outcomes. We expect this study to provide evidence for a full-scale confirmatory pRCT. TRIAL REGISTRATION: NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

Validation of the Questionnaire to Identify Knee Symptoms (QuIKS) using Rasch analysis.

BACKGROUND: The Questionnaire to Identify Knee Symptoms (QuIKS) was recently developed to promote activity by screening for experiences related to early symptoms in people with emergent chronic knee pain problems, such as osteoarthritis (OA) - like knee pain. The main purpose of the current study was to evaluate measurement properties of the QuIKS using Rasch analysis in a sample of people with knee symptoms consistent with symptomatic knee OA. METHOD: This study used cross-sectional data. The sample was 200 subjects along the following knee health continuum: pain-free healthy knees (n = 55) from a university community, knee pain with no knee OA diagnosis (n = 111) from a university-affiliated medical clinic, and patients with surgeon-diagnosed symptomatic knee OA awaiting high tibial osteotomy (n = 34) from a sports medicine surgical clinic. The 13-item QuIKS was evaluated for its factor structure, item- and person-fit, item's category response structure, differential item functioning by sex and obesity status, local item dependency, unidimensionality, and test precision. Subsequently, the QuIKS underwent known-groups analysis and convergent validity with the Knee injury and Osteoarthritis Outcome Score (KOOS). RESULTS: In the QuIKS, each item's category response structure was modified. No differential item functioning was observed. Local item dependency informed the formation of four testlets. This refined QuIKS obtained summary fit to the Rasch measurement model, unidimensionality, reliability (person separation index = 0.82), and interval-level scoring. Subsequently, the Rasch-validated QuIKS (QuIKS-R) demonstrated excellent known-groups validity and good convergent validity with the KOOS (Spearman's rho = 0.45 to 0.77). CONCLUSIONS: The QuIKS-R provides interval-level quantification of knee symptoms-related experiences in people with knee symptoms consistent with symptomatic knee OA. Its scores might be useful for clinicians for promoting activity in individuals with early symptoms consistent with symptomatic knee OA.

Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial.

BACKGROUND: Studies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms--one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis. METHODS: We conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (n = 98; mean age 60 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26 weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee. RESULTS: Adverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26 weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5 mm (p = 0.64) and 6.4 mm (p = 0.24) over Synvisc-One for Hydros and Hydros-TA, respectively. CONCLUSIONS: A single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26 weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results. TRIAL REGISTRATION NUMBER: NCT01134406.