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Objective To examine the feasibility of implementing remote atrial fibrillation (AF) self-screening among older people supported by a remote central monitoring system.Design Process evaluation of the Mass AF randomised clinical trial (ACTRN12621000184875) with one-to-one semistructured interviews using interview guides underpinned by the Critical Realism approach and coded using the UK Medical Research Council Guidance of Process Evaluation Framework.Setting and participants Community-dwelling people aged ≥75 years from both genders (ratio 1:1) and urban/rural (ratio 2:1) in Australia.Interventions Participants were provided handheld single-lead electrocardiogram (ECG) devices and trained to self-record ECGs once daily on weekdays for at least 6 months. A remote central team notified participants and general practitioners (GPs) of AF.Primary feasibility outcomes The strengths, weaknesses, opportunities and threats (SWOT) analysis examined enablers (ie, strengths and opportunities) and barriers (ie, weaknesses and threats).Results Overall, 200 participants; 98.5% completed the 6-month programme, 96% reported being satisfied with screening and 48 were interviewed: mean age 79 years, 54% male and 71% urban. 11 GPs were interviewed: 55% female and 64% urban. Programme participants trusted the remote monitoring system that supported the screening programme and provided follow-up pathways where required. GPs saw opportunities to introduce this self-screening programme to at-risk patients and improve patients’ risk profiles. Programme participants reported that after being trained to use the device, they felt empowered to do self-screening and found it convenient. GPs saw empowerment could enhance the doctor–patient relationship. Participants and GPs valued screening in diagnosing AF that would otherwise be missed in usual care, but the uncertainty of effective screening duration could be a barrier.Conclusions This screening programme was feasible with the reinforcement of the underpinning enablers. Several implementation strategies were identified using SWOT analysis, including leveraging the opportunity for GPs to introduce this screening programme to at-risk patients.Trial registration number ACTRN12621000184875.

Objectives The study explored the perceived impacts of COVID-19 and its associated policies and social restrictions on health, self-management and access to healthcare.Design Cross-sectional observational (online survey) and qualitative study (semi-structured interviews and thematic analysis).Setting Australia.Participants People with self-reported cardiovascular disease (CVD) and/or risk factors.Results Survey responses were collected from 690 participants (43.8% women, 40.1% over 65 years). Participants reported that their heart health had been affected by the pandemic (26.3%), were less likely to exercise (47.1%), have a healthy diet (25.9%) and take medications (9.4%). A large proportion were admitted to hospital (46.2%) and presented to the emergency department (40.6%). Difficulties in accessing healthcare providers (53.2%) and use of telemedicine (63.6%) were reported. We conducted 16 semi-structured interviews and identified five key themes: adding burden in seeking medical care, impediments in accessing a readjusted health system, exacerbating vulnerability and distress, coping with self-management and adapting to telehealth.Conclusions Patients with CVD expressed an additional burden in seeking medical care and difficulties navigating a readjusted health system during the COVID-19 pandemic. Associated policies and access issues heightened vulnerabilities and distress, making self-management of health difficult for patients with CVD.

BackgroundThis study evaluates primary care practices' engagement with various features of a quality improvement (QI) intervention for patients with coronary heart disease (CHD) in four Australian states.MethodsTwenty-seven practices participated in the QI intervention from November 2019 -November 2020. A combination of surveys, semi-structured interviews and other materials within the QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease (QUEL) study were used in the process evaluation. Data were summarised using descriptive statistical and thematic analyses for 26 practices.ResultsSixty-four practice team members and Primary Health Networks staff provided feedback, and nine of the 63 participants participated in the interviews. Seventy-eight percent (40/54) were either general practitioners or practice managers. Although 69% of the practices self-reported improvement in their management of heart disease, engagement with the intervention varied. Forty-two percent (11/26) of the practices attended five or more learning workshops, 69% (18/26) used Plan-Do-Study-Act cycles, and the median (Interquartile intervals) visits per practice to the online SharePoint site were 170 (146-252) visits. Qualitative data identified learning workshops and monthly feedback reports as the key features of the intervention.ConclusionPractice engagement in a multi-featured data-driven QI intervention was common, with learning workshops and monthly feedback reports identified as the most useful features. A better understanding of these features will help influence future implementation of similar interventions.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134.

Background Semi-structured interviews allow progressive interview refinements to gain an in-depth understanding of a research question, but interview refinements affect the stopping point. This paper aims to describe a method that provides transparency in interview refinements and helps researchers decide on a stopping point. Methods We established systematic and practical methods to document interview refinements and visualize novel and duplicate interview codes. We illustrated the methods using a case study called the Mass Atrial Fibrillation Screening Study, a real-world clinical trial. Interviews were audio recorded and transcribed progressively. Two researchers established the initial coding into a predefined framework with reference to the Medical Research Council Guidance of Process Evaluation. Final codes were reached by discussion and consensus. NVivo v12 software was utilized to manage the qualitative data. Results We developed an open-access software package for the ‘R’ statistical programming language called ‘novelqualcodes’ and a video demonstrating the application. Our package converts NVivo coding matrices into graphs of the trends of novel and duplicate codes. Our package also enables users to document interview refinements as fieldnotes, providing a visual guide to help researchers decide on a stopping point. In the case study, one researcher (KCW) conducted 48 one-to-one in-depth semi-structured interviews with participants from September 2021 to July 2022. Interview refinements were identified and reported to provide transparency to the readers. The novel code graphs and examination of the code sufficiency in the predefined framework demonstrated the stopping point at which we were satisfied with the richness and insights of the interviews in answering our research question. Conclusions We illustrated a new paradigm of systematic and practical methods and shared an open-access software package and a video to describe, document and visualize the path to the stopping point. This approach can be applied in other qualitative research using different predefined frameworks.

Background Bystander response, including cardiopulmonary resuscitation (CPR), is critical to out-of-hospital cardiac arrest (OHCA) survival. Nearly 30% of Australian residents were born overseas, and little is known about their preparedness to perform CPR. In this mixed-methods study, we examined rates of training and willingness and barriers to performing CPR among immigrants in Australia.Methods First, we surveyed residents in New South Wales, Australia, using purposeful sampling to enrich immigrant populations. Multivariate logistic regression was used to examine the association between place of birth and willingness to perform CPR. Next, we conducted focus-group discussions with members of the region’s largest migrant groups to explore barriers and relevant societal or cultural factors.Results Of the 1267 survey participants (average age 49.6 years, 52% female), 60% were born outside Australia, most in Asia and 73% had lived in Australia for more than 10 years. Higher rates of previous CPR training were reported among Australian-born participants compared with South Asian-born and East Asian-born (77%, 35%, 48%, respectively, p

BackgroundMaintaining engagement and support for patients with chronic diseases is challenging. SMS text messaging programs have complemented patient care in a variety of situations. However, such programs have not been widely translated into routine care. ObjectiveWe aimed to examine the implementation and utility of a customized SMS text message–based support program for patients with type 2 diabetes (T2D), coronary heart disease, or both within a chronic disease integrated care program. MethodsWe conducted a 6-month pragmatic parallel-group, single-blind randomized controlled trial that recruited people with T2D or coronary heart disease. Intervention participants received 4 semipersonalized SMS text messages per week providing self-management support to supplement standard care. Preprogrammed algorithms customized content based on participant characteristics, and the messages were sent at random times of the day and in random order by a fully automated SMS text messaging engine. Control participants received standard care and only administrative SMS text messages. The primary outcome was systolic blood pressure. Evaluations were conducted face to face whenever possible by researchers blinded to randomization. Participants with T2D were evaluated for glycated hemoglobin level. Participant-reported experience measures were evaluated using questionnaires and focus groups and summarized using proportions and thematic analysis. ResultsA total of 902 participants were randomized (n=448, 49.7% to the intervention group and n=454, 50.3% to the control group). Primary outcome data were available for 89.5% (807/902) of the participants. At 6 months, there was no difference in systolic blood pressure between the intervention and control arms (adjusted mean difference=0.9 mm Hg, 95% CI −1.1 to 2.1; P=.38). Of 642 participants with T2D, there was no difference in glycated hemoglobin (adjusted mean difference=0.1%, 95% CI −0.1% to 0.3%; P=.35). Self-reported medication adherence was better in the intervention group (relative risk=0.82, 95% CI 0.68-1.00; P=.045). Participants reported that the SMS text messages were useful (298/344, 86.6%) and easily understood (336/344, 97.7%) and motivated change (217/344, 63.1%). The lack of bidirectional messaging was identified as a barrier. ConclusionsThe intervention did not improve blood pressure in this cohort, possibly because of high clinician commitment to improved routine patient care as part of the chronic disease management program as well as favorable baseline metrics. There was high program engagement, acceptability, and perceived value. Feasibility as part of an integrated care program was demonstrated. SMS text messaging programs may supplement chronic disease management and support self-care. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12616001689460; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371769&isReview=true International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2018-025923

Introduction Cardiovascular disease (CVD) is associated with systemic inflammation. Colchicine, an anti-inflammatory drug, reduces the incidence of CVD events. Periodontitis, a chronic localised inflammatory disease of the tissues supporting the teeth, triggers systemic inflammation and contributes to inflammatory risk. Treatment for periodontitis reduces markers of inflammation, however, there is no evidence on whether an anti-inflammatory medication in combination with periodontal treatment can reduce the inflammatory risk. The aim of this trial is to investigate the effect of periodontal treatment either alone or in combination with an anti-inflammatory agent on inflammation in patients with periodontitis and CVD at 8 weeks.Methods and analysis 60 participants with moderate-to-severe periodontitis, coronary artery disease and an increased inflammatory risk (>2 mg/L high sensitivity C reactive protein (hsCRP) levels) will be recruited from a tertiary referral hospital in Australia in a parallel design, single blind, randomised controlled trial. Baseline hsCRP levels, lipid profile and periodontal assessment will be completed for each participant before they are randomised in a 1:1:1:1 ratio to one of 4 arms as follows: (group A) periodontal treatment and colchicine; (group B) periodontal treatment only; (group C) colchicine only or (group D) control/delayed periodontal treatment. Periodontal treatment will be provided over three treatment visits, 0.5 mg of colchicine will be provided as a daily tablet. Participants will be followed up at 8 weeks to measure primary and secondary outcomes and complete a follow-up questionnaire. The primary outcome is the difference in hsCRP levels, the secondary outcomes are differences in lipid levels and periodontal parameters and the feasibility measures of recruitment conversion rate, completion rate and the safety and tolerability of the trial.Ethics and dissemination The study has been approved by the Western Sydney Local Health District Human Ethics Committee (protocol number 2019/ETH00200). Results will be published in peer-reviewed journals and presented at conferences.Trial registration number ACTRN12619001573145.

ObjectivesTo examine i) the use of mobile apps and fitness trackers in adults during the COVID-19 pandemic to support health behaviors; ii) the use of COVID-19 apps; iii) associations between using mobile apps and fitness trackers, and health behaviors; iv) differences in usage amongst population subgroups.MethodsAn online cross-sectional survey was conducted during June-September 2020. The survey was developed and reviewed independently by co-authors to establish face validity. Associations between using mobile apps and fitness trackers and health behaviors were examined using multivariate logistic regression models. Subgroup analyses were conducted using Chi-square and Fisher's exact tests. Three open-ended questions were included to elicit participants' views; thematic analysis was conducted.ResultsParticipants included 552 adults (76.7% women; mean age: 38±13.6 years); 59.9% used mobile apps for health, 38.2% used fitness trackers, and 46.3% used COVID-19 apps. Users of mobile apps or fitness trackers had almost two times the odds of meeting aerobic physical activity guidelines compared to non-users (odds ratio = 1.91, 95% confidence interval 1.07 to 3.46, P = .03). More women used health apps than men (64.0% vs 46.8%, P = .004). Compared to people aged 18-44 (46.1%), more people aged 60+ (74.5%) and more people aged 45-60 (57.6%) used a COVID-19 related app (P < .001). Qualitative data suggest people viewed technologies (especially social media) as a 'double-edged sword': helping with maintaining a sense of normalcy and staying active and socially connected, but also having a negative emotional effect stemming from seeing COVID-related news. People also found that mobile apps did not adapt quickly enough to the circumstances caused by COVID-19.ConclusionsUse of mobile apps and fitness trackers during the pandemic was associated with higher levels of physical activity, in a sample of educated and likely health-conscious individuals. Future research is needed to understand whether the association between using mobile devices and physical activity is maintained in the long-term.

Objectives To investigate the feasibility of the be.well app and its personalization approach which regularly considers users’ preferences, amongst university students. Methods We conducted a mixed-methods, pre-post experiment, where participants used the app for 2 months. Eligibility criteria included: age 18–34 years; owning an iPhone with Internet access; and fluency in English. Usability was assessed by a validated questionnaire; engagement metrics were reported. Changes in physical activity were assessed by comparing the difference in daily step count between baseline and 2 months. Interviews were conducted to assess acceptability; thematic analysis was conducted. Results Twenty-three participants were enrolled in the study (mean age = 21.9 years, 71.4% women). The mean usability score was 5.6 ± 0.8 out of 7. The median daily engagement time was 2 minutes. Eighteen out of 23 participants used the app in the last month of the study. Qualitative data revealed that people liked the personalized activity suggestion feature as it was actionable and promoted user autonomy. Some users also expressed privacy concerns if they had to provide a lot of personal data to receive highly personalized features. Daily step count increased after 2 months of the intervention (median difference = 1953 steps/day, p -value

Objective: To investigate long-term adherence to guideline-recommended cardioprotective medications following hospitalization for an acute myocardial infarction (AMI), and identify characteristics associated with adherence.Methods: An Australian population-based cohort study was used to identify participants who had their first AMI between 2006 and 2014 and were alive after 12 months. Linked routinely collected hospital, and prescription medication claims data was used to study adherence over time. Predictors and rates of adherence to both lipid-lowering medication and renin-angiotensin system blockade at 12 months post-AMI was assessed.Results: 14,200 people (mean age 69.9 years, 38.7% female) were included in our analysis. At 12 months post-AMI, 29.5% (95% CI: 28.8–30.3%) of people were adherent to both classes of medication. Individuals receiving treatment with both lipid-lowering medication and renin-angiotensin system blockade during the 6 months prior to their AMI were over 9 times more likely to be adherent to both medications at 12 months post-AMI (66.2% 95% CI: 64.8–67.5%) compared to those with no prior medication use (treatment naïve) (7.1%, 95% CI: 6.4–7.9%). Prior cardiovascular treatment was the strongest predictor of long-term adherence even after adjusting for age, sex, education and income.Conclusions: Despite efforts to improve long-term medication adherence in patients who have experienced an acute coronary event, considerable gaps remain. Of particular concern are people who are commencing guideline-recommended cardioprotective medication at the time of their AMI. The relationship between prior cardiovascular treatments and post AMI adherence offers insight into the support needs for the patient. Health care intervention strategies, strengthened by enabling policies, are needed to provide support to patients through the initial months following their AMI.

BackgroundAtrial fibrillation (AF) is common in older people and increases the risk of stroke. The feasibility and effectiveness of the implementation of a patient-led AF screening program for older people are unknown. ObjectiveThis study aims to examine the feasibility and effectiveness of an AF screening program comprising patient-led monitoring of single-lead electrocardiograms (ECGs) with clinician-coordinated central monitoring to diagnose AF among community-dwelling people aged ≥75 years in Australia. MethodsThis is a nationwide randomized controlled implementation trial conducted via the internet and remotely among 200 community-dwelling adults aged ≥75 years with no known AF. Randomization will be performed in a 1:1 allocation ratio for the intervention versus control. Intervention group participants will be enrolled in the monitoring program at randomization. They will receive a handheld single-lead ECG device and training on the self-recording of ECGs on weekdays and submit their ECGs via their smartphones. The control group participants will receive usual care from their general practitioners for the initial 6 months and then commence the 6-month monitoring program. The ECGs will be reviewed centrally by trained personnel. Participants and their general practitioners will be notified of AF and other clinically significant ECG abnormalities. ResultsThis study will establish the feasibility and effectiveness of implementing the intervention in this patient population. The primary clinical outcome is the AF detection rate, and the primary feasibility outcome is the patient satisfaction score. Other outcomes include appropriate use of anticoagulant therapy, participant recruitment rate, program engagement (eg, frequency of ECG transmission), agreement in ECG interpretation between the device automatic algorithm and clinicians, the proportion of participants who complete the trial and number of dropouts, and the impact of frailty on feasibility and outcomes. We will conduct a qualitative evaluation to examine the barriers to and acceptability and enablers of implementation. Ethics approval was obtained from the human research ethics committee at the University of Sydney (project number 2020/680). The results will be disseminated via conventional scientific forums, including peer-reviewed publications and presentations at national and international conferences. ConclusionsBy incorporating an integrated health care approach involving patient empowerment, centralized clinician-coordinated ECG monitoring, and facilitation of primary care and specialist services, it is possible to diagnose and treat AF early to reduce stroke risk. This study will provide new information on how to implement AF screening using digital health technology practicably and feasibly for older and frail populations residing in the community. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12621000184875; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380877 International Registered Report Identifier (IRRID)DERR1-10.2196/34778

Background and aimOut-of-hospital cardiac arrest (OHCA) is a significant public health issue with low survival rates. Prompt bystander action can more than double survival odds. OHCA response training is primarily pursued due to work-related mandates, with few programs targeting communities with lower training levels. The aim of this research was to describe the development process of a targeted multicomponent intervention package designed to enhance confidence and training among laypeople in responding to an OHCA.MethodsAn iterative, three-phase program development process was employed using a mixed methods approach. The initial phase involved establishment of a multidisciplinary panel that informed decisions on key messages, program content, format, and delivery modes. These decisions were based on scientific evidence and guided by behavioural theories. The second phase comprised the development of the intervention package, identifying existing information and developing new material to fill identified gaps. The third phase involved refining and finalising the material via feedback from panel members, stakeholders, and community members.ResultsThrough this approach, we collaboratively developed a comprehensive evidence-based education and training package consisting of a digital intervention supplemented with free access to in-person education and training. The package was designed to teach community members the specific steps in recognising and responding to a cardiac arrest, while addressing commonly known barriers and fears related to bystander response. The tailored program and delivery format addressed the needs of individuals of diverse ages, cultural backgrounds, and varied training needs and preferences.ConclusionThe study highlights the importance of community engagement in intervention development and demonstrates the need of evidence-based and collaborative approaches in creating a comprehensive, localised, relatively low-cost intervention package to improve bystander response to OHCA.

BackgroundSMS text messages as a form of mobile health are increasingly being used to support individuals with chronic diseases in novel ways that leverage the mobility and capabilities of mobile phones. However, there are knowledge gaps in mobile health, including how to maximize engagement. ObjectiveThis study aims to categorize program SMS text messages and participant replies using machine learning (ML) and to examine whether message characteristics are associated with premature program stopping and engagement. MethodsWe assessed communication logs from SMS text message–based chronic disease prevention studies that encouraged 1-way (SupportMe/ITM) and 2-way (TEXTMEDS [Text Messages to Improve Medication Adherence and Secondary Prevention]) communication. Outgoing messages were manually categorized into 5 message intents (informative, instructional, motivational, supportive, and notification) and replies into 7 groups (stop, thanks, questions, reporting healthy, reporting struggle, general comment, and other). Grid search with 10-fold cross-validation was implemented to identify the best-performing ML models and evaluated using nested cross-validation. Regression models with interaction terms were used to compare the association of message intent with premature program stopping and engagement (replied at least 3 times and did not prematurely stop) in SupportMe/ITM and TEXTMEDS. ResultsWe analyzed 1550 messages and 4071 participant replies. Approximately 5.49% (145/2642) of participants responded with stop, and 11.7% (309/2642) of participants were engaged. Our optimal ML model correctly classified program message intent with 76.6% (95% CI 63.5%-89.8%) and replies with 77.8% (95% CI 74.1%-81.4%) balanced accuracy (average area under the curve was 0.95 and 0.96, respectively). Overall, supportive (odds ratio [OR] 0.53, 95% CI 0.35-0.81) messages were associated with reduced chance of stopping, as were informative messages in SupportMe/ITM (OR 0.35, 95% CI 0.20-0.60) but not in TEXTMEDS (for interaction, P

BackgroundThe provision of reliable patient education is essential for shared decision-making. However, many clinicians are reluctant to use commonly available resources, as they are generic and may contain information of insufficient quality. Clinician-created educational materials, accessed during the waiting time prior to consultation, can potentially benefit clinical practice if developed in a time- and resource-efficient manner. ObjectiveThe aim of this study is to evaluate the utility of educational videos in improving patient decision-making, as well as consultation satisfaction and anxiety, within the outpatient management of chronic disease (represented by atrial fibrillation). The approach involves clinicians creating audiovisual patient education in a time- and resource-efficient manner for opportunistic delivery, using mobile smart devices with internet access, during waiting time before consultation. MethodsWe implemented this educational approach in outpatient clinics and collected patient responses through an electronic survey. The educational module was a web-based combination of 4 short videos viewed sequentially, followed by a patient experience survey using 5-point Likert scales and 0-100 visual analogue scales. The clinician developed the audiovisual module over a 2-day span while performing usual clinical tasks, using existing hardware and software resources (laptop and tablet). Patients presenting for the outpatient management of atrial fibrillation accessed the module during waiting time before their consultation using either a URL or Quick Response (QR) code on a provided tablet or their own mobile smart devices. The primary outcome of the study was the module’s utility in improving patient decision-making ability, as measured on a 0-100 visual analogue scale. Secondary outcomes were the level of patient satisfaction with the videos, measured with 5-point Likert scales, in addition to the patient’s value for clinician narration and the module’s utility in improving anxiety and long-term treatment adherence, as represented on 0-100 visual analogue scales. ResultsThis study enrolled 116 patients presenting for the outpatient management of atrial fibrillation. The proportion of responses that were “very satisfied” with the educational video content across the 4 videos ranged from 93% (86/92) to 96.3% (104/108) and this was between 98% (90/92) and 99.1% (107/108) for “satisfied” or “very satisfied.” There were no reports of dissatisfaction for the first 3 videos, and only 1% (1/92) of responders reported dissatisfaction for the fourth video. The median reported scores (on 0-100 visual analogue scales) were 90 (IQR 82.5-97) for improving patient decision-making, 89 (IQR 81-95) for reducing consultation anxiety, 90 (IQR 81-97) for improving treatment adherence, and 82 (IQR 70-90) for the clinician’s narration adding benefit to the patient experience. ConclusionsClinician-created educational videos for chronic disease management resulted in improvements in patient-reported informed decision-making ability and expected long-term treatment adherence, as well as anxiety reduction. This form of patient education was also time efficient as it used the sunk time cost of waiting time to provide education without requiring additional clinician input.

BackgroundCardiac arrhythmias are a leading cause of death. The mainstay method for diagnosing arrhythmias (eg, atrial fibrillation) and cardiac conduction disorders (eg, prolonged corrected QT interval [QTc]) is by using 12-lead electrocardiography (ECG). Handheld 12-lead ECG devices are emerging in the market. In tandem with emerging technology options, evaluations of device usability should go beyond validation of the device in a controlled laboratory setting and assess user perceptions and experiences, which are crucial for successful implementation in clinical practice. ObjectiveThis study aimed to evaluate clinician and patient perceptions and experiences, regarding the usability of a handheld 12-lead ECG device compared to a conventional 12-lead ECG machine, and generalizability of this user-centered approach. MethodsInternational Organization for Standardization Guidelines on Usability and the Technology Acceptance Model were integrated to form the framework for this study, which was conducted in outpatient clinics and cardiology wards at Westmead Hospital, New South Wales, Australia. Each patient underwent 2 ECGs (1 by each device) in 2 postures (supine and standing) acquired in random sequence. The times taken by clinicians to acquire the first ECG (efficiency) using the devices were analyzed using linear regression. Electrocardiographic parameters (QT interval, QTc interval, heart rate, PR interval, QRS interval) and participant satisfaction surveys were collected. Device reliability was assessed by evaluating the mean difference of QTc measurements within ±15 ms, intraclass correlation coefficient, and level of agreement of the devices in detecting atrial fibrillation and prolonged QTc. Clinicians’ perceptions and feedback were assessed with semistructured interviews based on the Technology Acceptance Model. ResultsA total of 100 patients (age: mean 57.9 years, SD 15.2; sex: male: n=64, female n=36) and 11 clinicians (experience acquiring ECGs daily or weekly 10/11, 91%) participated, and 783 ECGs were acquired. Mean differences in QTc measurements of both handheld and conventional devices were within ±15 ms with high intraclass correlation coefficients (range 0.90-0.96), and the devices had a good level of agreement in diagnosing atrial fibrillation and prolonged QTc (κ=0.68-0.93). Regardless of device, QTc measurements when patients were standing were longer duration than QTc measurements when patients were supine. Clinicians’ ECG acquisition times improved with usage (P

BackgroundBreast cancer is the most common cancer among women globally. Recovery from breast cancer treatment can be mentally and physically challenging. SMS text message programs offer a novel way to provide health information and support, but few programs are co-designed with consumer representatives. ObjectiveThis study aims to report the procedures and outcomes of a co-design process of a lifestyle-focused SMS text message program to support women’s mental and physical health after breast cancer treatment. MethodsWe followed an iterative mixed methods two-step process: (1) co-design workshop with consumers and health professionals and researchers to draft text messages and (2) evaluation of message content, which was scored (5-point Likert scale; 1=strongly disagree to 5=strongly agree) for ease of understanding, usefulness, and appropriateness, and readability (Flesch-Kincaid score). Additional free-text responses and semistructured interviews were coded into themes. Messages were edited or deleted based on the evaluations, with consumers’ evaluations prioritized. ResultsIn step 1, co-designed text messages (N=189) were semipersonalized, and the main content themes were (1) physical activity and healthy eating, (2) medications and side effects, (3) mental health, and (4) general breast cancer information. In step 2, consumers (n=14) and health professionals and researchers (n=14) provided 870 reviews of 189 messages and found that most messages were easy to understand (799/870, 91.8%), useful (746/870, 85.7%), and appropriate (732/870, 84.1%). However, consumers rated 50 messages differently from health professionals and researchers. On the basis of evaluations, 37.6% (71/189) of messages were deleted, 36.5% (69/189) were edited, and 12 new messages related to fatigue, self-care, and cognition were created. The final 130 text messages had a mean 7.12 (SD 2.8) Flesch-Kincaid grade level and 68.9 (SD 15.5) ease-of-reading score, which represents standard reading ease. ConclusionsCo-designing and evaluating a bank of evidence-based mental and physical health-themed text messages with breast cancer survivors, health professionals, and researchers was feasible and resulted in a bank of 130 text messages evaluated highly by participants. Some consumer evaluations differed from health professionals and researchers, supporting the importance of co-design.

The unique characteristics of patients with chronic coronary syndrome (CCS) in the Asia-Pacific region, heterogeneous approaches because of differences in accesses and resources and low number of patients from the Asia-Pacific region in pivotal studies, mean that international guidelines cannot be routinely applied to these populations. The Asian Pacific Society of Cardiology developed these consensus recommendations to summarise current evidence on the management of CCS and provide recommendations to assist clinicians treat patients from the region. The consensus recommendations were developed by an expert consensus panel who reviewed and appraised the available literature, with focus on data from patients in Asia-Pacific. Consensus statements were developed then put to an online vote. The resulting recommendations provide guidance on the assessment and management of bleeding and ischaemic risks in Asian CCS patients. Furthermore, the selection of long-term antithrombotic therapy is discussed, including the role of single antiplatelet therapy, dual antiplatelet therapy and dual pathway inhibition therapy.

Aims: To use linked routinely-collected health data to estimate diabetes prevalence and incidence in an Australian cohort of adults aged ≥45 years, and examine risk factors associated with incident disease. Research design and methods: The EXamining ouTcomEs in chroNic Disease in the 45 and Up Study (EXTEND45) Study is a linked data study that combines baseline questionnaire responses from the population-based 45 and Up Study (2006–2009, n = 267,153) with multiple routinely-collected health databases up to December 2014. Among participants with ≥1 linked result for any laboratory test, diabetes status was determined from multiple data sources according to standard biochemical criteria, use of glucose-lowering medication or self-report, and the prevalence and incidence rate calculated. Independent risk factors of incident diabetes were examined using multivariable Cox regression. Results: Among 152,169 45 and Up Study participants with ≥1 linked laboratory result in the EXTEND45 database (mean age 63.0 years; 54.9% female), diabetes prevalence was 10.8% (95% confidence interval [CI] 10.6%–10.9%). Incident disease in those without diabetes at baseline (n = 135,810; mean age 62.5 years; 56.1% female) was 10.0 per 1,000 person-years (95% CI 9.8–10.2). In all age groups, diabetes incidence was lower in women compared to men, an association that persisted in the fully adjusted analyses. Other independent risk factors of diabetes were older age, being born outside of Australia (with the highest rate of 19.2 per 1,000 person-years observed in people born in South and Central Asia), lower education status, lower annual household income, residence in a major city, family history of diabetes, personal history of cardiovascular disease or hypertension, higher body mass index, smoking and long sleeping hours. Conclusions: Our study represents an efficient approach to assessing diabetes frequency and its risk factors in the community. The infrastructure provided by the EXTEND45 Study will be useful for diabetes surveillance and examining other important clinical and epidemiological questions.

Background: Studies have demonstrated the effectiveness of text message-based prevention programs on smoking cessation, including our recently published TEXTME randomised controlled trial. However, little is known about the predictors of smoking cessation in this context and if other clinically important factors interact with the program to lead to quitting. Hence, the objective of this study was to first assess the predictors of smoking cessation in TEXTME and then determine if the effect of texting on quitting was modified by interactions with important clinical variables. This will allow us to better understand how text messaging works and thus help optimise future text-message based prevention programs. Methods This sub-analysis used data collected as part of the TEXTME trial which recruited 710 participants (377 current smokers at baseline) between September 2011 and November 2013 from a large tertiary hospital in Sydney, Australia. Smokers at baseline were analysed at 6 months and grouped into those who quit and those who did not. Univariate analyses were performed to determine associations between the main outcome and clinically important baseline factors selected a priori. A multiple binominal logistic regression analysis was conducted to develop a predictive model for the dependent variable smoking cessation. A test of interaction between the intervention group and baseline variables selected a priori with the outcome smoking cessation was performed. Results Univariate analysis identified receiving text-messages, age, and mean number of cigarettes smoked each day as being associated with quitting smoking. After adjusting for age, receiving the text-messaging program (OR 2.34; 95%CI 1.43-3.86; p

BACKGROUND:New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS:We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS:While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION:The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Summary: Background: Coronary heart disease is rapidly increasing in developing countries, but access to cardiac rehabilitation and secondary prevention remains low. In this study, we aimed to assess the effectiveness of a smartphone-based cardiac rehabilitation and secondary prevention programme delivered via the social media platform WeChat (SMART-CR/SP). Methods: In this parallel-group, single-blind, randomised controlled trial, we recruited patients aged 18 years or older with coronary heart disease who had received percutaneous coronary interventions from a large tertiary hospital in Shanghai, China. Participants were randomly assigned (1:1) by block randomisation to either a 2-month intensive programme followed by a 4-month step-down phase of SMART-CR/SP or to usual care. In the SMART-CR/SP group, participants received comprehensive cardiac rehabilitation and secondary prevention via WeChat. The usual care group received standard outpatient cardiology follow-up but without formal cardiac rehabilitation and secondary prevention. Assessments were done at baseline, 2 months, 6 months, and 12 months. The primary outcome was change in functional capacity from baseline, measured by 6-min walk distance, at 2 months and 6 months. Analysis was by intention to treat. Research personnel involved in assessments were blinded to group allocation. Adverse-event analysis was based on percentage of patients who discontinued the study owing to adverse events. SMART-CR/SP programme-related safety issues were also recorded. This study was registered with the Chinese Clinical Trial Registry, number ChiCTR-INR-16009598. Findings: Between Nov 17, 2016, and March 18, 2017, 312 patients (mean age 60·5 years [SD 9·2]), of whom 58 (19%) were female and 254 (81%) were male, were recruited and subsequently randomly assigned to SMART-CR/SP (n=156) or usual care (n=156). The improvement in 6-min walk distance at 2 months was significantly greater in the SMART-CR/SP group (from 489·2 m [99·4] at baseline to 539·1 m [68·0]) than in the control group (from 485·0 m [93·5] at baseline to 517·8 m [74.6]), with an adjusted mean difference of 20·64 m (95% CI 7·50–33·77; p=0·034). This improvement was maintained at 6 months (mean 6-min walk distance 543·4 m [67·5] in the SMART-CR/SP group vs 523·5 m [60·2] in the control group), with a mean between-group difference of 22·29 m (8·19–36·38; p=0·027). No adverse events or SMART-CR/SP programme-related safety issues were reported by participants during the study. Interpretation: SMART-CR/SP was found to be a cardiac rehabilitation and secondary prevention service model with high efficacy and accessibility and to be easy to use. These results justify the implementation of similar models of care on a broader scale. Funding: Curtin University.

Abstract Objective To examine and compare tobacco marketing in 16 countries while the Framework Convention on Tobacco Control requires parties to implement a comprehensive ban on such marketing. Methods Between 2009 and 2012, a kilometre-long walk was completed by trained investigators in 462 communities across 16 countries to collect data on tobacco marketing. We interviewed community members about their exposure to traditional and non-traditional marketing in the previous six months. To examine differences in marketing between urban and rural communities and between high-, middle- and low-income countries, we used multilevel regression models controlling for potential confounders. Findings Compared with high-income countries, the number of tobacco advertisements observed was 81 times higher in low-income countries (incidence rate ratio, IRR: 80.98; 95% confidence interval, CI: 4.15-1578.42) and the number of tobacco outlets was 2.5 times higher in both low- and lower-middle-income countries (IRR: 2.58; 95% CI: 1.17-5.67 and IRR: 2.52; CI: 1.23-5.17, respectively). Of the 11 842 interviewees, 1184 (10%) reported seeing at least five types of tobacco marketing. Self-reported exposure to at least one type of traditional marketing was 10 times higher in low-income countries than in high-income countries (odds ratio, OR: 9.77; 95% CI: 1.24-76.77). For almost all measures, marketing exposure was significantly lower in the rural communities than in the urban communities. Conclusion Despite global legislation to limit tobacco marketing, it appears ubiquitous. The frequency and type of tobacco marketing varies on the national level by income group and by community type, appearing to be greatest in low-income countries and urban communities.

Summary: Background: There is little evidence on the use of secondary prevention medicines for cardiovascular disease by socioeconomic groups in countries at different levels of economic development. Methods: We assessed use of antiplatelet, cholesterol, and blood-pressure-lowering drugs in 8492 individuals with self-reported cardiovascular disease from 21 countries enrolled in the Prospective Urban Rural Epidemiology (PURE) study. Defining one or more drugs as a minimal level of secondary prevention, wealth-related inequality was measured using the Wagstaff concentration index, scaled from −1 (pro-poor) to 1 (pro-rich), standardised by age and sex. Correlations between inequalities and national health-related indicators were estimated. Findings: The proportion of patients with cardiovascular disease on three medications ranged from 0% in South Africa (95% CI 0–1·7), Tanzania (0–3·6), and Zimbabwe (0–5·1), to 49·3% in Canada (44·4–54·3). Proportions receiving at least one drug varied from 2·0% (95% CI 0·5–6·9) in Tanzania to 91·4% (86·6–94·6) in Sweden. There was significant (p

INTRODUCTION:Electronic health (eHealth) strategies are evolving making it important to have valid scales to assess eHealth and health literacy. Item response theory methods, such as the Rasch measurement model, are increasingly used for the psychometric evaluation of scales. This paper aims to examine the internal construct validity of an eHealth and health literacy scale using Rasch analysis in a population with moderate to high cardiovascular disease risk. METHODS:The first 397 participants of the CONNECT study completed the electronic health Literacy Scale (eHEALS) and the Health Literacy Questionnaire (HLQ). Overall Rasch model fit as well as five key psychometric properties were analysed: unidimensionality, response thresholds, targeting, differential item functioning and internal consistency. RESULTS:The eHEALS had good overall model fit (χ2 = 54.8, p = 0.06), ordered response thresholds, reasonable targeting and good internal consistency (person separation index (PSI) 0.90). It did, however, appear to measure two constructs of eHealth literacy. The HLQ subscales (except subscale 5) did not fit the Rasch model (χ2: 18.18-60.60, p: 0.00-0.58) and had suboptimal targeting for most subscales. Subscales 6 to 9 displayed disordered thresholds indicating participants had difficulty distinguishing between response options. All subscales did, nonetheless, demonstrate moderate to good internal consistency (PSI: 0.62-0.82). CONCLUSION:Rasch analyses demonstrated that the eHEALS has good measures of internal construct validity although it appears to capture different aspects of eHealth literacy (e.g. using eHealth and understanding eHealth). Whilst further studies are required to confirm this finding, it may be necessary for these constructs of the eHEALS to be scored separately. The nine HLQ subscales were shown to measure a single construct of health literacy. However, participants' scores may not represent their actual level of ability, as distinction between response categories was unclear for the last four subscales. Reducing the response categories of these subscales may improve the ability of the HLQ to distinguish between different levels of health literacy.

Objective: The aim of this study was to assess the reach, acceptability, utility, and engagement with the apps that were used in the MEDication reminder APPlications (apps) to improve medication adherence in Coronary Heart Disease (MedApp-CHD) study, a randomised clinical trial to improve medication adherence, using a mixed-methods approach. Methods: The MedApp-CHD study randomised 163 patients with coronary heart disease (CHD) to one of three groups: (i) usual care (n = 56), (ii) a basic medication reminder app (n = 54), or (iii) an advanced medication reminder app (n = 53). For this mixed-methods evaluation, the data sources included patient screening logs, feedback questionnaires collected at three-month follow-up, focus groups discussions, and analytical data from the app software. Results: Ninety-four percent (98/104) of participants who received a medication reminder app completed the three-month feedback questionnaire and 15 participated in the focus group discussions. The themes that were identified included that participants (i) found the medication reminders useful in reminding them to take the medications on the correct time every day, (ii) liked having the medication list as an easily-accessible record of medications’ names and dosages, (iii) reported being likely to continue to use the apps after the study completion, (iv) would be likely to recommend the apps to their family and friends, and (v) those who used the clinical measurements feature found it useful as a tool to track and graph the blood pressure and glucose levels over time (especially those with diabetes and/or hypertension). In addition, analytical data from the app software demonstrated that the participants used the medication-related features more than the clinical measurements feature. Furthermore, data from the patient screening logs showed that the main reason for exclusion, other than not meeting the CHD criteria, was not having a suitable smartphone, and those that were excluded for this reason were older and had a higher proportion of females than those enrolled in the study. Conclusion: This study provides important insights regarding the features that are most useful in apps that aim to improve medication adherence. This mixed-methods evaluation suggests that, currently, young male patients with CHD are more likely to use such apps, that the apps were well-accepted and useful in reminding the patients to take the medications, and that the patients were engaged in regularly using the apps.

Background: Several international guidelines recommend the consumption of two servings of fruits and three servings of vegetables per day, but their intake is thought to be low worldwide. We aimed to determine the extent to which such low intake is related to availability and affordability. Methods: We assessed fruit and vegetable consumption using data from country-specific, validated semi-quantitative food frequency questionnaires in the Prospective Urban Rural Epidemiology (PURE) study, which enrolled participants from communities in 18 countries between Jan 1, 2003, and Dec 31, 2013. We documented household income data from participants in these communities; we also recorded the diversity and non-sale prices of fruits and vegetables from grocery stores and market places between Jan 1, 2009, and Dec 31, 2013. We determined the cost of fruits and vegetables relative to income per household member. Linear random effects models, adjusting for the clustering of households within communities, were used to assess mean fruit and vegetable intake by their relative cost. Findings: Of 143 305 participants who reported plausible energy intake in the food frequency questionnaire, mean fruit and vegetable intake was 3·76 servings (95% CI 3·66–3·86) per day. Mean daily consumption was 2·14 servings (1·93–2·36) in low-income countries (LICs), 3·17 servings (2·99–3·35) in lower-middle-income countries (LMICs), 4·31 servings (4·09–4·53) in upper-middle-income countries (UMICs), and 5·42 servings (5·13–5·71) in high-income countries (HICs). In 130 402 participants who had household income data available, the cost of two servings of fruits and three servings of vegetables per day per individual accounted for 51·97% (95% CI 46·06–57·88) of household income in LICs, 18·10% (14·53–21·68) in LMICs, 15·87% (11·51–20·23) in UMICs, and 1·85% (−3·90 to 7·59) in HICs (ptrend=0·0001). In all regions, a higher percentage of income to meet the guidelines was required in rural areas than in urban areas (p

Many studies have now demonstrated the efficacy of text messaging in positively changing behaviours. We aimed to identify features and factors that explain the effectiveness of a successful text messaging program in terms of user engagement, perceived usefulness, behavior change and program delivery preferences.Mixed methods qualitative design combining four data sources; (i) analytic data extracted directly from the software system, (ii) participant survey, (iii) focus groups to identify barriers and enablers to implementation and mechanisms of effect and (iv) recruitment screening logs and text message responses to examine engagement. This evaluation was conducted within the TEXT ME trial-a parallel design, single-blind randomized controlled trial (RCT) of 710 patients with coronary heart disease (CHD). Qualitative data were interpreted using inductive thematic analysis.307/352 (87% response rate) of recruited patients with CHD completed the program evaluation survey at six months and 25 participated in a focus group. Factors increasing engagement included (i) ability to save and share messages, (ii) having the support of providers and family, (iii) a feeling of support through participation in the program, (iv) the program being initiated close to the time of a cardiovascular event, (v) personalization of the messages, (vi) opportunity for initial face-to-face contact with a provider and (vii) that program and content was perceived to be from a credible source. Clear themes relating to program delivery were that diet and physical activity messages were most valued, four messages per week was ideal and most participants felt program duration should be provided for at least for six months or longer.This study provides context and insight into the factors influencing consumer engagement with a text message program aimed at improving health-related behavior. The study suggests program components that may enhance potential success but will require integration at the development stage to optimize up-scaling.Australia and New Zealand Clinical Trials Registry, ACTRN12611000161921.

Previous research has shown that environments with features that encourage walking are associated with increased physical activity. Existing methods to assess the built environment using geographical information systems (GIS) data, direct audit or large surveys of the residents face constraints, such as data availability and comparability, when used to study communities in countries in diverse parts of the world. The aim of this study was to develop a method to evaluate features of the built environment of communities using a standard set of photos. In this report we describe the method of photo collection, photo analysis instrument development and inter-rater reliability of the instrument.A minimum of 5 photos were taken per community in 86 communities in 5 countries according to a standard set of instructions from a designated central point of each community by researchers at each site. A standard pro forma derived from reviewing existing instruments to assess the built environment was developed and used to score the characteristics of each community. Photo sets from each community were assessed independently by three observers in the central research office according to the pro forma and the inter-rater reliability was compared by intra-class correlation (ICC). Overall 87% (53 of 60) items had an ICC of ≥ 0.70, 7% (4 of 60) had an ICC between 0.60 and 0.70 and 5% (3 of 60) items had an ICC ≤ 0.50.Analysis of photos using a standardized protocol as described in this study offers a means to obtain reliable and reproducible information on the built environment in communities in very diverse locations around the world. The collection of the photographic data required minimal training and the analysis demonstrated high reliability for the majority of items of interest.

OBJECTIVE: To describe the socioeconomic and geographic distribution of smoking behaviour in Canada among 19,383 individuals (51% women) aged 15-85 years. METHODS: Current smoking and quitting were modeled using standard and multilevel logistic regression. Markers of socioeconomic status (SES) were education and occupation. Geography was defined by Canadian Provinces. RESULTS: The adjusted prevalence of current smoking was 20.2% (95% confidence interval [CI]: 18.8-21.7) and 63.7% (95% CI: 61.1-66.3) of ever smokers had quit. Current smoking decreased and quitting increased with increasing SES. The adjusted prevalence of current smoking was 32.8% (95% CI: 28.4-37.5) among the least educated compared to 11.0% (95% CI: 8.9-13.4) for the highest educated. Among the least educated, 53.0% (95% CI: 46.8-59.2) had quit, rising to 68.7% (95% CI: 62.7-74.1) for the most educated. There was substantial variation in current smoking and quitting at the provincial level; current smoking varied from 17.9% in British Columbia to 26.1% in Nova Scotia, and quitting varied from 57.4% in Nova Scotia to 67.8% in Prince Edward Island. Nationally, increasing education and occupation level were inversely associated with current smoking (odds ratio [OR] 0.64, 95% CI: 0.60-0.68 for education; OR 0.82, 95% CI: 0.77-0.87 for occupation) and positively associated with quitting (OR 1.27, 95% CI: 1.16-1.40 for education; OR 1.20, 95% CI: 1.12-1.27 for occupation). These associations were consistent in direction across provinces although with some variability in magnitude. CONCLUSION: Our findings indicate that socioeconomic inequalities in smoking have persisted in Canada; current smoking was less likely and quitting was more likely among the better off groups and in certain provinces. Current prevention and cessation policies have not been successful in improving the situation for all areas and groups. Future efforts to reduce smoking uptake and increase cessation in Canada will need consideration of socioeconomic and geographic factors to be successful.

BACKGROUND: Public health research has turned towards examining upstream, community-level determinants of cardiovascular disease risk factors. Objective measures of the environment, such as those derived from direct observation, and perception-based measures by residents have both been associated with health behaviours. However, current methods are generally limited to objective measures, often derived from administrative data, and few instruments have been evaluated for use in rural areas or in low-income countries. We evaluate the reliability of a quantitative tool designed to capture perceptions of community tobacco, nutrition, and social environments obtained from interviews with residents in communities in 5 countries. METHODOLOGY/ PRINCIPAL FINDINGS: Thirteen measures of the community environment were developed from responses to questionnaire items from 2,360 individuals residing in 84 urban and rural communities in 5 countries (China, India, Brazil, Colombia, and Canada) in the Environmental Profile of a Community's Health (EPOCH) study. Reliability and other properties of the community-level measures were assessed using multilevel models. High reliability (>0.80) was demonstrated for all community-level measures at the mean number of survey respondents per community (n = 28 respondents). Questionnaire items included in each scale were found to represent a common latent factor at the community level in multilevel factor analysis models. CONCLUSIONS/ SIGNIFICANCE: Reliable measures which represent aspects of communities potentially related to cardiovascular disease (CVD)/risk factors can be obtained using feasible sample sizes. The EPOCH instrument is suitable for use in different settings to explore upstream determinants of CVD/risk factors.

The environment in which people live is known to be important in influencing diet, physical activity, smoking, psychosocial and other risk factors for cardiovascular (CV) disease. However no instrument exists that evaluates communities for these multiple environmental factors and is suitable for use across different communities, regions and countries. This report describes the design and reliability of an instrument to measure environmental determinants of CV risk factors.THE ENVIRONMENTAL PROFILE OF COMMUNITY HEALTH (EPOCH) INSTRUMENT COMPRISES TWO PARTS: (I) an assessment of the physical environment, and (II) an interviewer-administered questionnaire to collect residents' perceptions of their community. We examined the inter-rater reliability amongst 3 observers from each region of the direct observation component of the instrument (EPOCH I) in 93 rural and urban communities in 5 countries (Canada, Colombia, Brazil, China and India). Data collection using the EPOCH instrument was feasible in all communities. Reliability of the instrument was excellent (Intraclass Correlation Coefficient--ICC>0.75) for 24 of 38 items and fair to good (ICC 0.4-0.75) for 14 of 38 items.This report shows data collection with the EPOCH instrument is feasible and direct observation of community measures reliable. The EPOCH instrument will enable further research on environmental determinants of health for population studies from a broad range of settings.