Publications by authors named "Karla Santo"

24 Publications

  • Page 1 of 1

Community Group-Based Models of Medication Delivery: Applicability to Cardiovascular Diseases.

Glob Heart 2021 May 5;16(1):36. Epub 2021 May 5.

The George Institute for Global Health, UNSW, Sydney, AU.

The rising global burden of chronic non-communicable diseases (NCDs) has put a strain on healthcare systems globally, especially in low- and middle-income countries, which have seen disproportionate mortality rates due to non-communicable diseases. These deaths are in part due to challenges with medication adherence, which are compounded by lack of access to medication and weak community support systems. This paper aims to propose a potential solution using models of service delivery in HIV/AIDS, given the many similarities between NCD and HIV/AIDS. Models that have been particularly effective in HIV/AIDS are the community-based peer-support medication delivery groups: medication adherence clubs and community antiretroviral therapy (ART) groups. The positive outcomes from these models, including improved medication adherence and patient satisfaction, provide evidence for their potential success when applied to non-communicable diseases, particularly hypertension and cardiovascular disease.
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http://dx.doi.org/10.5334/gh.763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8103852PMC
May 2021

Mobile Apps for Dental Caries Prevention: Systematic Search and Quality Evaluation.

JMIR Mhealth Uhealth 2021 01 13;9(1):e19958. Epub 2021 Jan 13.

Sydney School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Westmead, Australia.

Background: Dental caries is the most common multifactorial oral disease; it affects 60% to 90% of the global population. Dental caries is highly preventable through prevention behaviors aimed at improving oral hygiene, adequate fluoride usage, and dietary intake. Mobile apps have the potential to support patients with dental caries; however, little is known about the availability, target audience, quality, and features of these apps.

Objective: This review aims to systematically examine dental caries prevention apps; to describe their content, availability, target audience, and features; and to assess their quality.

Methods: We systematically identified and evaluated apps in a process paralleling a systematic review. This included a search strategy using search terms; an eligibility assessment using inclusion and exclusion criteria focused on accessibility and dental caries self-management behaviors, including oral hygiene, dietary intake, and fluoride usage; data extraction on app characteristics, including app store metrics; prevention behavior categorization; feature identification and description; a quality appraisal of all apps using the validated Mobile App Rating Scale (MARS) assessment tool; and data comparison and analysis.

Results: Using our search strategy, we retrieved 562 apps from the Google Play Store and iTunes available in Australia. Of these, 7.1% (40/562) of the apps fit our eligibility criteria, of which 55% (22/40) targeted adults, 93% (37/40) were free to download, and 65% (26/40) were recently updated. Oral hygiene was the most common dental caries prevention behavior domain, addressed in 93% (37/40) of the apps, while dietary intake was addressed in 45% (18/40) of the apps and fluoride usage was addressed in 42% (17/40) of the apps. Overall, 50% (20/40) of the apps addressed only 1 behavior, and 38% (15/40) of the apps addressed all 3 behaviors. The mean MARS score was 2.9 (SD 0.7; range 1.8-4.4), with 45% (18/40) of the apps categorized as high quality, with a rating above 3.0 out of 5.0. We identified 21 distinctive features across all dental caries prevention behaviors; however, the top 5 most common features focused on oral hygiene. The highest-ranking app was the Brush DJ app, with an overall MARS score of 4.4 and with the highest number of features (n=13). We did not find any apps that adequately addressed dental caries prevention behaviors in very young children.

Conclusions: Apps addressing dental caries prevention commonly focus on oral hygiene and target young adults; however, many are not of high quality. These apps use a range of features to support consumer engagement, and some of these features may be helpful for specific patient populations. However, it remains unclear how effective these apps are in improving dental caries outcomes, and further evaluation is required before they are widely recommended.
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http://dx.doi.org/10.2196/19958DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840287PMC
January 2021

Validation of the Mobile Application Rating Scale (MARS).

PLoS One 2020 2;15(11):e0241480. Epub 2020 Nov 2.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University Ulm, Ulm, Germany.

Background: Mobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity.

Objective: This study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS.

Methods: Data was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation.

Results: In total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (ps<.05).

Conclusion: The metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0241480PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605637PMC
December 2020

Digital Health Innovations to Improve Cardiovascular Disease Care.

Curr Atheroscler Rep 2020 10 3;22(12):71. Epub 2020 Oct 3.

Westmead Applied Research Centre, Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

Purpose Of Review: To review the current evidence supporting the use of digital health technologies in cardiovascular disease (CVD) care.

Recent Findings: Studies have evaluated the impact of the use of digital health technologies to improve CVD outcomes through several modalities: text-messaging programmes, smartphone applications (apps) and wearable devices. Text-messaging programmes are to date the most studied type of digital health interventions, and studies have demonstrated reduced CVD risk and improved medication adherence. Literature supporting the use of smartphone apps is also growing but remains limited, with some studies favouring the use of health apps but others showing negative results. Wearable devices are the latest type of technology investigated, and studies have shown positive outcomes in terms of physical activity and detection of arrhythmias. Digital health is a growing and evolving area of investigation. To date, the scientific evidence overall supports the use of such technologies in CVD care and management. Future research using new models are needed to continue to evaluate these new technologies.
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http://dx.doi.org/10.1007/s11883-020-00889-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532121PMC
October 2020

Social distancing in Latin America during the COVID-19 pandemic: an analysis using the Stringency Index and Google Community Mobility Reports.

J Travel Med 2020 12;27(8)

Academic Research Organization, Hospital Israelita Albert Einstein, 627 Av. Albert Einstein, Jardim Leonor, 05652-900, Sao Paulo, Brasil.

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http://dx.doi.org/10.1093/jtm/taaa125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454760PMC
December 2020

Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis.

Open Heart 2019;6(2):e001017. Epub 2019 Oct 9.

Cardiovascular Division, The George Institute for Global Health, Sydney, New South Wales, Australia.

Background: A variety of small mobile phone text-messaging interventions have indicated improvement in risk factors for cardiovascular disease (CVD). Yet the extent of this improvement and whether it impacts multiple risk factors together is uncertain. We aimed to conduct a systematic review and individual patient data (IPD) meta-analysis to investigate the effects of text-messaging interventions for CVD prevention.

Methods: Electronic databases were searched to identify trials investigating a text-messaging intervention focusing on CVD prevention with the potential to modify at least two CVD risk factors in adults. The main outcome was blood pressure (BP). We conducted standard and IPD meta-analysis on pooled data. We accounted for clustering of patients within studies and the primary analysis used random-effects models. Sensitivity and subgroup analyses were performed.

Results: Nine trials were included in the systematic review involving 3779 participants and 5 (n=2612) contributed data to the IPD meta-analysis. Standard meta-analysis showed that the weighted mean differences are as follows: systolic blood pressure (SBP), -4.13 mm Hg (95% CI -11.07 to 2.81, p<0.0001); diastolic blood pressure (DBP), -1.11 mm Hg (-1.91 to -0.31, p=0.002); and body mass index (BMI), -0.32 (-0.49 to -0.16, p=0.000). In the IPD meta-analysis, the mean difference are as follows: SBP, -1.3 mm Hg (-5.4 to 2.7, p=0.5236); DBP, -0.8 mm Hg (-2.5 to 1.0, p=0.3912); and BMI, -0.2 (-0.8 to 0.4, p=0.5200) in the random-effects model. The impact on other risk factors is described, but there were insufficient data to conduct meta-analyses.

Conclusion: Mobile phone text-messaging interventions have modest impacts on BP and BMI. Simultaneous but small impacts on multiple risk factors are likely to be clinically relevant and improve outcome, but there are currently insufficient data in pooled analyses to examine the extent to which simultaneous reduction in multiple risk factors occurs.

Prospero Registration Number: CRD42016033236.
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http://dx.doi.org/10.1136/openhrt-2019-001017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802999PMC
February 2021

The Potential of mHealth Applications in Improving Resistant Hypertension Self-Assessment, Treatment and Control.

Curr Hypertens Rep 2019 10 9;21(10):81. Epub 2019 Oct 9.

Westmead Applied Research Centre, Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

Purpose Of Review: To review the evidence supporting the use of mobile health (mHealth) apps to improve resistant hypertension self-assessment, treatment and control.

Recent Findings: mHealth apps have been used to directly measure blood pressure (BP) levels, either using the oscillometric method with automated inflatable cuffs or using pulse wave signals detected by smartphone technology without the need for cuffs. These app-based BP monitors tend to over or underestimate BP levels when compared to a gold standard aneroid sphygmomanometer. However, the differences in BP measurements are within the acceptable range of 5 mmHg pre-defined by the European Society of Hypertension International Protocol Revision 2010. mHealth apps are also used as tools to support physicians in improving hypertension treatment. App-based clinical decision support systems are innovative solutions, in which patient information is entered in the app and management algorithms provide recommendations for hypertension treatment. The use of these apps has been shown to be feasible and easily integrated into the workflow of healthcare professionals, and, therefore particularly useful in resource-limited settings. In addition, apps can be used to improve hypertension control by facilitating regular BP monitoring, communication between patients and health professionals, and patient education; as well as by reinforcing behaviours through reminders, including medication-taking and appointment reminders. Several studies provided evidence supporting the use of apps for hypertension control. Although some of the results are promising, there is still limited evidence on the benefits of using such mHealth tools, as these studies are relatively small and with a short-term duration. Recent research has shown that mHealth apps can be beneficial in terms of improving hypertension self-assessment, treatment and control, being especially useful to help differentiate and manage true and pseudo-resistant hypertension. However, future research, including large-scale randomised clinical trials with user-centred design, is crucial to further evaluate the potential scalability and effectiveness of such mHealth apps in the resistant hypertension context.
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http://dx.doi.org/10.1007/s11906-019-0986-zDOI Listing
October 2019

Adapting a club-based medication delivery strategy to a hypertension context: the CLUBMEDS Study in Nigeria.

BMJ Open 2019 07 9;9(7):e029824. Epub 2019 Jul 9.

Department of Medicine - Cardiology, Baylor College of Medicine, Houston, USA.

Introduction: The prevalence of hypertension in sub-Saharan Africa is among the world's highest; however, awareness, treatment and control of hypertension in this region are suboptimal. Among other barriers, the overburdened healthcare system poses a great challenge for hypertension control. Community peer-support groups are an alternative and promising strategy to improve adherence and blood pressure (BP) control. The CLUBMEDS study aims to evaluate the feasibility and impact of adherence clubs to improve hypertension control in Nigeria.

Methods And Analysis: The CLUBMEDS study will include a formative (pre-implementation) qualitative evaluation, a pilot study and a process (postimplementation) qualitative evaluation. At the formative stages, focus group discussions with patient groups and in-depth interviews with healthcare providers, managers and key decision makers will be conducted to understand the feasibility, barriers and facilitators, opportunities and challenges for the successful implementation of the CLUBMEDS strategy. The CLUBMEDS pilot study will be implemented in two primary healthcare facilities, one urban and one rural, in Southeast Nigeria. Each adherence club, which consists of a group of 10-15 patients with hypertension under the leadership of a role-model patient, serves as a support group to encourage and facilitate adherence, BP self-monitoring and medication delivery on a monthly basis. A process evaluation will be conducted at the end of the pilot study to evaluate the acceptability and engagement with the CLUBMEDS strategy. To date, 104 patients were recruited and grouped into nine clubs, in which patients will be followed-up for 6 months.

Ethics And Dissemination: The study was approved by the University of Abuja Teaching Hospital and the Federal Teaching Hospital Abakaliki Human Research Ethics Committees and all patients provided informed consent. Our findings will provide preliminary data on the potential effectiveness and acceptance of this strategy in a hypertension context. Study findings will be disseminated via scientific forums.
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http://dx.doi.org/10.1136/bmjopen-2019-029824DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6629410PMC
July 2019

Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation.

Med Sci (Basel) 2019 Jun 4;7(6). Epub 2019 Jun 4.

Westmead Applied Research Centre, Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2145, Australia.

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 ( = 56), (ii) a basic medication reminder app ( = 54), or (iii) an advanced medication reminder app ( = 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.
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http://dx.doi.org/10.3390/medsci7060068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6631463PMC
June 2019

ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial.

BMJ Open 2019 03 1;9(3):e023863. Epub 2019 Mar 1.

Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.

Introduction: Simple and scalable strategies are needed to improve 'out-of-hospital' support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.

Methods And Analysis: Pragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation.

Ethics And Dissemination: Primary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease.

Trial Registration Number: ACTRN12616001167459.
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http://dx.doi.org/10.1136/bmjopen-2018-023863DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430023PMC
March 2019

Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial.

Heart 2019 02 27;105(4):323-329. Epub 2018 Aug 27.

Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.

Objective: The aim of the MEDication reminder APPs to improve medication adherence in Coronary Heart Disease Study was to evaluate the effectiveness and feasibility of using publicly available high-quality medication reminder applications (apps) to improve medication adherence compared with usual care in patients with coronary heart disease (CHD). An additional aim was to examine whether an app with additional features improved adherence further.

Methods: Patients with CHD (n=163) were randomised to one of three groups: (1) usual care, (2) a basic app or (3) an advanced app with interactive/customisable features. The primary analysis compared usual care versus app use on the primary outcome of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 3 months. Secondary outcomes included blood pressure and cholesterol levels.

Results: The mean age was 57.9 years and 87.7% were male. At 3 months, patients using an app had higher adherence (mean MMAS-8 score 7.11) compared with the usual care group (mean MMAS-8 score 6.63) with a mean difference between groups of 0.47 (95% CI 0.12 to 0.82, p=0.008). There was no significant difference in patients using the basic app versus the advanced app (mean difference -0.16, 95% CI -0.56 to 0.24, p=0.428). There were no significant differences in secondary clinical outcome measures.

Conclusion: Patients with CHD who used medication reminder apps had better medication adherence compared with usual care, and using apps with additional features did not improve this outcome further. These data suggest medication apps are likely to help patients with chronic health conditions adhere to medicines, but further examination of whether such benefits are sustained is warranted.

Clinical Trial Registration Number: ACTRN12616000661471; Results.
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http://dx.doi.org/10.1136/heartjnl-2018-313479DOI Listing
February 2019

Implementation of a text message intervention to promote behavioural change and weight loss among overweight and obese Brazilian primary care patients.

J Telemed Telecare 2019 Sep 27;25(8):476-483. Epub 2018 Jun 27.

1 Telehealth Center, University Hospital, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

Introduction: Mobile-technology-based interventions are promising strategies for promoting behavioural change in obese patients. The aims of this study were to evaluate the feasibility of implementing a text message intervention, and to assess the effects of the intervention on body mass index (BMI) and self-reported behavioural change.

Methods: TELEFIT was a three-phase feasibility study comprising the following stages: (a) the development of text messages; (b) testing; and (c) a quasi-experimental pilot study in which patients who were engaged in obesity/overweight educational groups in public primary care centres in Belo Horizonte, Brazil, were recruited. A bank of text messages was drafted and reviewed by an expert panel, text message delivery software was developed and tested, and a pilot study assessed patients before and after receiving the intervention using validated questionnaires and body measures. The data were analysed using the Wilcoxon test.

Results: A total of 46 patients completed the follow-up; 93.5% were women and the median age was 42 years (interquartile range (IQR) 34-52 years). At four months, participants had a significant reduction in BMI (median 31.3 (IQR 28.2-34.6) vs. 29.9 (IQR 27.2-34.6) kg/m,  < 0.001), systolic (median 125 (IQR 120-132) vs. 120 (IQR 110-130) mmHg,  = 0.013) and diastolic blood pressure (median 80 (IQR 70-100) vs. 80 (IQR 70-80) mmHg,  = 0.006), when compared to baseline. All patients reported to be satisfied and willing to continue receiving the intervention, and 93.3% felt that the intervention helped them change their behaviours.

Discussion: This study has shown that a text message intervention to promote behavioural change and weight loss was feasible and effective in a short-term period. Participants were satisfied and willing to continue receiving the SMS messages.
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http://dx.doi.org/10.1177/1357633X18782092DOI Listing
September 2019

The effects of a lifestyle-focused text-messaging intervention on adherence to dietary guideline recommendations in patients with coronary heart disease: an analysis of the TEXT ME study.

Int J Behav Nutr Phys Act 2018 05 23;15(1):45. Epub 2018 May 23.

The George Institute for Global Health, Sydney, Australia.

Background: A healthy diet is an important component of secondary prevention of coronary heart disease (CHD). The TEXT ME study was a randomised clinical trial of people with CHD that were randomised into standard care or a text-message programme in addition to standard care. This analysis aimed to: 1) assess the effects of the intervention onadherence to the dietary guideline recommendations; 2) assess the consistency of effect across sub-groups; and 3) assess whether adherence to the dietary guideline recommendations mediated the improvements in objective clinical outcomes.

Methods: Dietary data were collected using a self-report questionnaire to evaluate adherence to eight dietary guideline recommendations in Australia, including consumption of vegetables, fruits, fish, type of fat used for cooking and in spreads, takeaway food, salt and standard alcohol drinks. The primary outcome of this analysis was the proportion of patients adhering to ≥ 4 dietary guideline recommendations concomitantly and each recommendation was assessed individually as secondary outcomes. Data were analysed using log-binomial regression for categorical variables and analysis of covariance for continuous variables.

Results: Among 710 patients, 54% were adhering to ≥ 4 dietary guideline recommendations (intervention 53% vs control 56%, p = 0.376) at baseline. At six months, the intervention group had a significantly higher proportion of patients adhering to ≥ 4 recommendations (314, 93%) compared to the control group (264, 75%, RR 1.23, 95% CI 1.15-1.31, p < 0.001). In addition, the intervention patients reported consuming higher amounts of vegetables, fruits, and fish per week; less takeaway foods per week; and greater salt intake control. The intervention had a similar effect in all sub-groups tested. There were significant mediational effects of the increase in adherence to the recommendations for the association between the intervention and LDL-cholesterol (p < 0.001) and body mass index (BMI) at six months follow-up (p = 0.005).

Conclusion: A lifestyle-focused text-message programme improved adherence to the dietary guideline recommendations, and specifically improved self-reported consumption of vegetables, fruits, fish, takeaway foods and salt intake. Importantly, these improvements partially mediated improvements in LDL-cholesterol and BMI. This simple and scalable text-messaging intervention could be used as a strategy to improve diet in people with CHD.

Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12611000161921 . Registered on 10 February 2011.
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http://dx.doi.org/10.1186/s12966-018-0677-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967045PMC
May 2018

TEXT messages to improve MEDication adherence and Secondary prevention (TEXTMEDS) after acute coronary syndrome: a randomised clinical trial protocol.

BMJ Open 2018 01 27;8(1):e019463. Epub 2018 Jan 27.

Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Background: Identifying simple, low-cost and scalable means of supporting lifestyle change and medication adherence for patients following a cardiovascular (CV) event is important.

Objective: The TEXTMEDS (TEXT messages to improve MEDication adherence and Secondary prevention) study aims to investigate whether a cardiac education and support programme sent via mobile phone text message improves medication adherence and risk factor levels in patients following an acute coronary syndrome (ACS).

Study Design: A single-blind, multicentre, randomised clinical trial of 1400 patients after an ACS with 12 months follow-up. The intervention group will receive multiple weekly text messages that provide information, motivation, support to adhere to medications, quit smoking (if relevant) and recommendations for healthy diet and exercise. The primary endpoint is the percentage of patients who are adherent to cardioprotective medications and the key secondary outcomes are mean systolic blood pressure (BP) and low-density lipoprotein cholesterol. Secondary outcomes will also include total cholesterol, mean diastolic BP, the percentage of participants who are adherent to each cardioprotective medication class, the percentage of participants who achieve target levels of CV risk factors, major vascular events, hospital readmissions and all-cause mortality. The study will be augmented by formal economic and process evaluations to assess acceptability, utility and cost-effectiveness.

Summary: The study will provide multicentre randomised trial evidence of the effects of a text message-based programme on cardioprotective medication adherence and levels of CV risk factors.

Ethics And Dissemination: Primary ethics approval was received from Western Sydney Local Health District Human Research Ethics Committee (HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15). Results will be disseminated via peer-reviewed publications and presentations at international conferences.

Trial Registration Number: ACTRN12613000793718; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2017-019463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5829769PMC
January 2018

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

BMJ Open 2017 Oct 8;7(10):e017540. Epub 2017 Oct 8.

Cardiovascular Division, The George Institute for Global Health, Sydney, Australia.

Introduction: The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.

Methods And Analysis: Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.

Ethics And Dissemination: Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.

Trial Registration Number: ACTRN12616000661471; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2017-017540DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640083PMC
October 2017

Mobile Phone Apps to Improve Medication Adherence: A Systematic Stepwise Process to Identify High-Quality Apps.

JMIR Mhealth Uhealth 2016 Dec 2;4(4):e132. Epub 2016 Dec 2.

The George Institute for Global Health, University of Sydney, Sydney, Australia.

Background: There are a growing number of mobile phone apps available to support people in taking their medications and to improve medication adherence. However, little is known about how these apps differ in terms of features, quality, and effectiveness.

Objective: We aimed to systematically review the medication reminder apps available in the Australian iTunes store and Google Play to assess their features and their quality in order to identify high-quality apps.

Methods: This review was conducted in a similar manner to a systematic review by using a stepwise approach that included (1) a search strategy; (2) eligibility assessment; (3) app selection process through an initial screening of all retrieved apps and full app review of the included apps; (4) data extraction using a predefined set of features considered important or desirable in medication reminder apps; (5) analysis by classifying the apps as basic and advanced medication reminder apps and scoring and ranking them; and (6) a quality assessment by using the Mobile App Rating Scale (MARS), a reliable tool to assess mobile health apps.

Results: We identified 272 medication reminder apps, of which 152 were found only in Google Play, 87 only in iTunes, and 33 in both app stores. Apps found in Google Play had more customer reviews, higher star ratings, and lower cost compared with apps in iTunes. Only 109 apps were available for free and 124 were recently updated in 2015 or 2016. Overall, the median number of features per app was 3.0 (interquartile range 4.0) and only 18 apps had ≥9 of the 17 desirable features. The most common features were flexible scheduling that was present in 56.3% (153/272) of the included apps, medication tracking history in 54.8% (149/272), snooze option in 34.9% (95/272), and visual aids in 32.4% (88/272). We classified 54.8% (149/272) of the included apps as advanced medication reminder apps and 45.2% (123/272) as basic medication reminder apps. The advanced apps had a higher number of features per app compared with the basic apps. Using the MARS instrument, we were able to identify high-quality apps that were rated as being very interesting and entertaining, highly interactive and customizable, intuitive, and easy to use and to navigate as well as having a high level of visual appeal and good-quality information.

Conclusions: Many medication reminder apps are available in the app stores; however, the majority of them did not have many of the desirable features and were, therefore, considered low quality. Through a systematic stepwise process, we were able to identify high-quality apps to be tested in a future study that will provide evidence on the use of medication reminder apps to improve medication adherence.
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http://dx.doi.org/10.2196/mhealth.6742DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5161780PMC
December 2016

Text2PreventCVD: protocol for a systematic review and individual participant data meta-analysis of text message-based interventions for the prevention of cardiovascular diseases.

BMJ Open 2016 10 17;6(10):e012723. Epub 2016 Oct 17.

The George Institute for Global Health, Sydney, Australia.

Introduction: Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs).

Methods And Analysis: Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings.

Ethics And Dissemination: Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences.

Trial Registration Number: CRD42016033236.
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http://dx.doi.org/10.1136/bmjopen-2016-012723DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5073594PMC
October 2016

Factors Influencing Engagement, Perceived Usefulness and Behavioral Mechanisms Associated with a Text Message Support Program.

PLoS One 2016 14;11(10):e0163929. Epub 2016 Oct 14.

The George Institute for Global Health, Sydney, Australia.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial Registration: Australia and New Zealand Clinical Trials Registry, ACTRN12611000161921.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0163929PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065147PMC
June 2017

Interventions to improve medication adherence in coronary disease patients: A systematic review and meta-analysis of randomised controlled trials.

Eur J Prev Cardiol 2016 07 14;23(10):1065-76. Epub 2016 Mar 14.

The George Institute for Global Health, University of Sydney, Australia Sydney Medical School, University of Sydney, Australia.

Background: Adherence to multiple cardiovascular (CV) medications is a cornerstone of coronary heart disease (CHD) management and prevention, but it is sub-optimal worldwide. This review aimed to examine whether interventions improve adherence to multiple CV medications in a CHD population.

Design: This study was based on a systematic review and meta-analysis according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.

Methods: Randomised controlled trials were identified by searching multiple databases and reference lists. Studies were selected if they evaluated interventions aiming to improve adherence to multiple CV medications targeting a CHD population and if they provided an appropriate measure of adherence. Interventions were classified as complex or simple interventions. Odds ratios (ORs) were calculated and pooled for a meta-analysis. Risk of bias, heterogeneity and publication bias were also assessed.

Results: Sixteen studies (10,706 patients) were included. The mean age was 62 years (standard deviation (SD) 3.6) and 72% were male. In a pooled analysis, the interventions significantly improved medication adherence (OR 1.52; 95% confidence interval (CI) 1.25-1.86; p < 0.001) and there were no significant differences based on intervention type (complex vs simple), components categories and adherence method. There was moderate heterogeneity (I(2) ( )= 61%) across the studies. After adjusting for publication bias, the effect size was attenuated but remained significant (OR 1.35; 95% CI 1.09-1.68).

Conclusion: Interventions to improve adherence to multiple CV medication in a CHD population significantly improved the odds of being adherent. Simple one-component interventions might be a promising way to improve medication adherence in a CHD population, as they would be easier to replicate in different settings and on a large scale.
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http://dx.doi.org/10.1177/2047487316638501DOI Listing
July 2016

Impact of medical consultation frequency on risk factors and medications 6 months after acute coronary syndrome.

Public Health Res Pract 2016 Jan 28;26(1):e2611606. Epub 2016 Jan 28.

The George Institute for Global Health, Sydney Medical School, The University of Sydney, NSW, Australia,

Objective: Initiatives that support primary care to better enable delivery of optimal prevention services are of great importance. The purpose of this study was to examine the frequency of medical consultations by patients with acute coronary syndrome (ACS) in the 6 months after hospital discharge and to determine whether the frequency of visits was associated with differences in lifestyle, clinical measures and medication prescription.

Methods: We conducted a retrospective subgroup analysis of data collected in the Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events (CONCORDANCE), which is an ongoing (prospective) clinical initiative providing continuous real-time reporting on the clinical characteristics, management and outcomes of patients admitted to Australian hospitals with ACS. We compared clinical measures, medications, smoking status and receipt of cardiac rehabilitation with frequency of medical consultations 6 months after hospital discharge.

Results: Patients with ACS visited their general practitioner (GP) a mean of 4.4 (± 3.8) times and their cardiologist 1.2 (± 0.9) times in the 6-month period after their index admission. Patients who saw a GP in the 6-month period had significantly higher rates of participation in cardiac rehabilitation, receipt of dietary advice and prescription of cardioprotective medications. Factors associated with increased frequency of GP visits were older age groups (oldest fourth vs youngest fourth incidence rate ratio (IRR) 1.08; 95% CI 1.01, 1.14), being female (male vs female IRR 0.83; 95% CI 0.80, 0.86), diagnosis of ST-segment elevation myocardial infarction (STEMI) (STEMI vs non-STEMI IRR 1.08; 95% CI 1.04, 1.13; STEMI vs unstable angina IRR 1.01; 95% CI 0.95, 1.06), being a current smoker (IRR 1.09; 95% CI 1.05, 1.15), history of cardiovascular disease (IRR 1.06; 95% CI 1.01, 1.12), history of diabetes (IRR 1.25; 95% CI 1.21, 1.31), inpatient revascularisation (IRR 0.95; 95% CI 0.91, 0.99), receipt of cardiac rehabilitation referral (IRR 0.93; 95% CI 0.89, 0.97), and discharged on four or more out of five indicated medications (IRR 1.04; 95% CI 1.00, 1.08).

Conclusion: The majority of ACS survivors in this study saw their GP frequently and their cardiologist at least once during the 6 months after index admission. Seizing these opportunities to engage, manage and support patients is important for strengthening prevention in primary care.
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http://dx.doi.org/10.17061/phrp2611606DOI Listing
January 2016

Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis.

JAMA Intern Med 2016 Mar;176(3):340-9

Department of Cardiology, Westmead Hospital, Sydney, Australia2The George Institute for Global Health, The University of Sydney, Sydney, Australia3The University of Sydney, Sydney, Australia.

Importance: Adherence to long-term therapies in chronic disease is poor. Traditional interventions to improve adherence are complex and not widely effective. Mobile telephone text messaging may be a scalable means to support medication adherence.

Objectives: To conduct a meta-analysis of randomized clinical trials to assess the effect of mobile telephone text messaging on medication adherence in chronic disease.

Data Sources: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL (from database inception to January 15, 2015), as well as reference lists of the articles identified. The data were analyzed in March 2015.

Study Selection: Randomized clinical trials evaluating a mobile telephone text message intervention to promote medication adherence in adults with chronic disease.

Data Extraction: Two authors independently extracted information on study characteristics, text message characteristics, and outcome measures as per the predefined protocol.

Main Outcomes And Measures: Odds ratios and pooled data were calculated using random-effects models. Risk of bias and study quality were assessed as per Cochrane guidelines. Disagreement was resolved by consensus.

Results: Sixteen randomized clinical trials were included, with 5 of 16 using personalization, 8 of 16 using 2-way communication, and 8 of 16 using a daily text message frequency. The median intervention duration was 12 weeks, and self-report was the most commonly used method to assess medication adherence. In the pooled analysis of 2742 patients (median age, 39 years and 50.3% [1380 of 2742] female), text messaging significantly improved medication adherence (odds ratio, 2.11; 95% CI, 1.52-2.93; P < .001). The effect was not sensitive to study characteristics (intervention duration or type of disease) or text message characteristics (personalization, 2-way communication, or daily text message frequency). In a sensitivity analysis, our findings remained robust to change in inclusion criteria based on study quality (odds ratio, 1.67; 95% CI, 1.21-2.29; P = .002). There was moderate heterogeneity (I2 = 62%) across clinical trials. After adjustment for publication bias, the point estimate was reduced but remained positive for an intervention effect (odds ratio, 1.68; 95% CI, 1.18-2.39).

Conclusions And Relevance: Mobile phone text messaging approximately doubles the odds of medication adherence. This increase translates into adherence rates improving from 50% (assuming this baseline rate in patients with chronic disease) to 67.8%, or an absolute increase of 17.8%. While promising, these results should be interpreted with caution given the short duration of trials and reliance on self-reported medication adherence measures. Future studies need to determine the features of text message interventions that improve success, as well as appropriate patient populations, sustained effects, and influences on clinical outcomes.
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http://dx.doi.org/10.1001/jamainternmed.2015.7667DOI Listing
March 2016

Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial.

JAMA 2015 Sep 22-29;314(12):1255-63

Westmead Hospital, Sydney, Australia8University of Sydney, Sydney, Australia.

Importance: Cardiovascular disease prevention, including lifestyle modification, is important but underutilized. Mobile health strategies could address this gap but lack evidence of therapeutic benefit.

Objective: To examine the effect of a lifestyle-focused semipersonalized support program delivered by mobile phone text message on cardiovascular risk factors.

Design And Setting: The Tobacco, Exercise and Diet Messages (TEXT ME) trial was a parallel-group, single-blind, randomized clinical trial that recruited 710 patients (mean age, 58 [SD, 9.2] years; 82% men; 53% current smokers) with proven coronary heart disease (prior myocardial infarction or proven angiographically) between September 2011 and November 2013 from a large tertiary hospital in Sydney, Australia.

Interventions: Patients in the intervention group (n = 352) received 4 text messages per week for 6 months in addition to usual care. Text messages provided advice, motivational reminders, and support to change lifestyle behaviors. Patients in the control group (n=358) received usual care. Messages for each participant were selected from a bank of messages according to baseline characteristics (eg, smoking) and delivered via an automated computerized message management system. The program was not interactive.

Main Outcomes And Measures: The primary end point was low-density lipoprotein cholesterol (LDL-C) level at 6 months. Secondary end points included systolic blood pressure, body mass index (BMI), physical activity, and smoking status.

Results: At 6 months, levels of LDL-C were significantly lower in intervention participants, with concurrent reductions in systolic blood pressure and BMI, significant increases in physical activity, and a significant reduction in smoking. The majority reported the text messages to be useful (91%), easy to understand (97%), and appropriate in frequency (86%). [table: see text].

Conclusions And Relevance: Among patients with coronary heart disease, the use of a lifestyle-focused text messaging service compared with usual care resulted in a modest improvement in LDL-C level and greater improvement in other cardiovascular disease risk factors. The duration of these effects and hence whether they result in improved clinical outcomes remain to be determined.

Trial Registration: anzctr.org.au Identifier: ACTRN12611000161921.
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http://dx.doi.org/10.1001/jama.2015.10945DOI Listing
October 2015

Challenges and opportunities associated with quantification of cardiovascular readmissions.

J Am Heart Assoc 2014 Sep 18;3(5):e001340. Epub 2014 Sep 18.

The George Institute for Global Health, Sydney Medical School, University of Sydney, Australia (J.R., K.H., K.S.).

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http://dx.doi.org/10.1161/JAHA.114.001340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4323831PMC
September 2014

Pacemaker endocarditis caused by Propionibacterium acnes in an adult patient with Ebstein's anomaly: a report of a rare case.

Heart Lung Circ 2014 Oct 3;23(10):e222-5. Epub 2014 Jul 3.

Department of Infection Control, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil; Senior Lecturer, Unigranrio, Rio de Janeiro, Brazil; Infectious Diseases Inpatient Unit, Instituto de Pesquisa Clínica Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil.

We report a rare case of a Brazilian adult woman with Ebstein's Anomaly who presented with pacemaker endocarditis caused by Propionibacterium acnes. Ebstein's Anomaly is a rare congenital malformation of the heart. Infective endocarditis is defined as an infection of heart valves, of the mural endocardium, of a septal defect, or of a cardiac electronic implantable device. Propionibacterium acnes is a skin commensal bacterium, that is usually considered as a contaminant, but can, on rare occasions, cause serious infections including endocarditis of prosthetic valves, native valves and cardiac electronic implantable devices. Diagnosis was made after nearly two years of investigation by identification of the organism by the MALDI-TOF technique and transoesophageal echocardiogram. The patient was successfully treated with daptomycin and device removal. She remains free of endocarditis after 32 months of follow-up.
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http://dx.doi.org/10.1016/j.hlc.2014.06.009DOI Listing
October 2014