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Online Tobacco Cessation Training & Competency Assessment for CAM Practitioners: Protocol for the CAM Reach Web Study

Despite development of relapse prevention intervention s ranging in intensity from extended counseling and/or pharmacotherapy to minimal interventions (e.g. mailed booklets), overall long-term success rates of smoking quit attempts remains low. To date, relapse prevention interventions have focused on the newly abstinent smoker (“abstainer”), and not attempted to directly or indirectly influence the abstainer’s personal network, e .g. by helping the abstainer influence others in their personal network to quit. Personal networks (PNs) have powerful effects on initiating and maintaining smoking behavior and they also have great potential to facilitate smoking cessation. A “reach out and help others” intervention that seeks to increase the abstainer’s ability to influence smokers in their PN to quit – thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. Possible mechanisms include: 1) encouraging public commitment to abstinence (within PN); 2) creating cognitive dissonance with resuming smoking; 3) reinforcing/consolidating learning of cessation benefits/effective aids (through teaching others); 4) maintaining engagement with the quit attempt (through helping others quit); 5) providing additional or alternative strategies for coping with smokers in the social environment, and 6) shifting the PN’s norms toward smoking abstinence. The Helpers Program (“Helpers”) is an existing on-line tobacco cessation brief intervention ( BI ) training program that teaches lay community members how to help tobacco users quit through a non-confrontational “helping conversation” (BI). The Helpers approach emphasizes active listening and motivational communication skills to encourage quitting – with particular attention given to avoiding confrontation and nagging, reinforcing motivations for quitting, and encouraging use of effective cessation aids (e.g. quit lines, cessation medications). We propose to test the feasibility and acceptability of Helpers as a relapse prevention intervention with these Specific Aims: 1) Modify the Helpers Program website for use as a pilot relapse prevention intervention with new abstainers completing the Arizona Smokers’ Helpline ( ASH ) telephone based tobacco cessation program; 2) Conduct an observational feasibility pilot study with 120 abstainers (30-day abstinent) to examine: a) feasibility of recruiting and retaining participants in the study, b) participant initiation and completion of Helpers training, c) self-reported delivery of BIs to other tobacco users, and d) the number , timing, and duration of participants’ lapses/relapses to smoking; and 3) Conduct a social network analysis (SNA) pilot feasibility study with the same 120 abstainers to examine feasibility and acceptability of SNA methods, and various PN parameters needed to design a full-scale SNA study assessing effects of Helpers on PNs, including: a) recruitment and retention of newly abstinent smokers, b) changes in participants’ PNs over course of the study (size, composition, structure, number of current/former smokers), c) presence or absence, effect and spread of smoking cessation related information and behaviors within PNs.

2015-07-01

(June 2015) Thomson Reuters, producer of the Journal Citation Reports and Web of Science and other database products, is creating a new edition of Web of Science (Emerging Sources Citation Index, ESCI); and we are proud to report that JMIR journals have been selected for the content expansion. 

The new Thomson Reuters Web of Science edition ESCI, which launches later in 2015, will include influential journals covering a variety of disciplines. "The journals selected have been identified as important to key opinion leaders, funders, and evaluators worldwide.", says a Thomson Reuters communication about the database. "We are proud that the Thomson Reuters team recognizes the influence of the JMIR journals", commented Gunther Eysenbach, publisher at JMIR Publications.

The following journals are confirmed to be part of the initial ESCI release, with more JMIR journals to be added:

JMIR Publications is working on getting its newer journals such as JMIR Mental Health into the collection as well. JMIR Publications is now publishing over a dozen journals with topics covering innovation in health and technology.

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

  • JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
 
 

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FreeDigitalPhotos.net - Photo by Stuart Miles.

    Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    Abstract:

    Background: Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective: This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods: In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results: The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions: This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial Registration: The Netherlands Trial Register NTR4297; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4297 (Archived by WebCite at http://webcitation.org/6Uwb5SUUM).

  • Image Source: Jonathan Moore - Creating the Ideal Microcosm for Rapid Incorporation of Bioengineered Alternative Tissues Using An Advanced Hydrogel Impregnated Gauze Dressing: A Case Series. The Foot and Ankle Online Journal 1 (9): 2. http://faoj.org/2008/09/01/creating-the-ideal-microcosm-for-rapid-incorporation-of-bioengineered-alternative-tissues-using-an-advanced-hydrogel-impregnated-gauze-dressing-a-case-series/. Licensed under Creative Commons Attribution.

    Interleukin 2 Topical Cream for Treatment of Diabetic Foot Ulcer: Experiment Protocol

    Authors List:

    Abstract:

    Background: It is estimated there are 2.9 million diabetic patients in the United Kingdom, and around 5%-7% of patients have diabetic ulcers. This number will continue to increase globally. Diabetic ulcers are a major economic burden on the healthcare system. More than £650 million is spent on foot ulcers or amputations each year, and up to 100 people a week have a limb amputated due to diabetes. In T1DM, the level of IL-2 is reduced, and hence, wound healing is in a prolonged inflammatory phase. It is not known if IL-2 topical cream can shorten the healing process in T1DM patients. Objective: The objective of this study is to understand the pathophysiology in type 1 diabetes (T1DM) and investigate possible future treatment based on its clinical features. The hypothesis is that IL-2 cream can speed up wound healing in NOD mice and that this can be demonstrated in a ten-week study. An experiment protocol is designed in a mouse model for others to conduct the experiment. The discussion is purely based on diabetic conditions; lifestyle influences like smoking and drinking are not considered. Methods: Skin incisions will be created on 20 nonobese diabetic (NOD) mice, and IL-2 topical cream will be applied in a 10-week study to prove the hypothesis. Mice will be randomly and equally divide into two groups with one being the control group. Results: T1DM patients have a decreased number of T regulatory (Treg) cells and interleukin 2 (IL-2). These are the keys to the disease progression and delay in wound healing. Diabetic ulcer is a chronic wound and characterized by a prolonged inflammatory phase. Conclusions: If the experiment is successful, T1DM patients will have an alternative, noninvasive treatment of foot ulcers. In theory, patients with other autoimmune diseases could also use IL-2 topical cream for treatment.

  • Homepage of the Dutch website.

    Feasibility of a Website and a Hospital-Based Online Portal for Young Adults With Juvenile Idiopathic Arthritis: Views and Experiences of Patients

    Abstract:

    Background: To improve knowledge and to encourage active involvement of young adults with juvenile idiopathic arthritis (JIA), an informative website with written and video information and an online portal with access to the personal medical record, self-monitoring, and e-consult functionalities were developed. Before implementing these applications in daily practice, it is important to gain insight into their feasibility in terms of ease of use, perceived usefulness and intention to use. Objective: The aim of this study was to evaluate and to examine the feasibility of the website and the online portal for young adults with JIA. Methods: A qualitative, feasibility study was conducted among the first users: 13 young adults with JIA. After provided access to the website and online portal, patients were interviewed on perceived usefulness, ease of use, and intention to (re)use the applications. Results: Participants in the study considered the website and online portal as useful and easy-to-use. New medical information and feedback would motivate them to revisit the applications again. On the website, videos showing other young adults, telling how they handle their condition, were found as the most useful. On the portal, access to their medical records was most appreciated: it made the young JIA patients feel in control and it helped them monitor symptoms and disease activity. e-consults were thought to facilitate communication with physicians. Conclusions: The young adults considered both the website and the online portal as feasible, but they also had valuable suggestions to improve accessibility and use. Based on these findings, a news and event section was added on the website and a direct link was made to a discussion board and social media. To provide and support health information, the website is actively used in daily care. Considering the online portal, the use of self-monitoring tools and e-consult can be stimulated if there is direct linkage to treatment and feedback from the multidisciplinary team. Feasibility testing, before implementing the website and online portal in daily practice, has proven to be a valuable step. Results led to improvements in terms of integration into standard care and topics for further research.

  • TOC picture, focus on business modeling part of CeHRes roadmap.

    Business Modeling to Implement an eHealth Portal for Infection Control: A Reflection on Co-Creation With Stakeholders

    Abstract:

    Background: It is acknowledged that the success and uptake of eHealth improve with the involvement of users and stakeholders to make technology reflect their needs. Involving stakeholders in implementation research is thus a crucial element in developing eHealth technology. Business modeling is an approach to guide implementation research for eHealth. Stakeholders are involved in business modeling by identifying relevant stakeholders, conducting value co-creation dialogs, and co-creating a business model. Because implementation activities are often underestimated as a crucial step while developing eHealth, comprehensive and applicable approaches geared toward business modeling in eHealth are scarce. Objective: This paper demonstrates the potential of several stakeholder-oriented analysis methods and their practical application was demonstrated using Infectionmanager as an example case. In this paper, we aim to demonstrate how business modeling, with the focus on stakeholder involvement, is used to co-create an eHealth implementation. Methods: We divided business modeling in 4 main research steps. As part of stakeholder identification, we performed literature scans, expert recommendations, and snowball sampling (Step 1). For stakeholder analyzes, we performed “basic stakeholder analysis,” stakeholder salience, and ranking/analytic hierarchy process (Step 2). For value co-creation dialogs, we performed a process analysis and stakeholder interviews based on the business model canvas (Step 3). Finally, for business model generation, we combined all findings into the business model canvas (Step 4). Results: Based on the applied methods, we synthesized a step-by-step guide for business modeling with stakeholder-oriented analysis methods that we consider suitable for implementing eHealth. Conclusions: The step-by-step guide for business modeling with stakeholder involvement enables eHealth researchers to apply a systematic and multidisciplinary, co-creative approach for implementing eHealth. Business modeling becomes an active part in the entire development process of eHealth and starts an early focus on implementation, in which stakeholders help to co-create the basis necessary for a satisfying success and uptake of the eHealth technology.

  • Screenshot of prototype version of the COPDFlix CER Network home page.

    Evaluating Comparative Effectiveness Research Priorities for Care Coordination in Chronic Obstructive Pulmonary Disease: A Community-Based eDelphi Study

    Abstract:

    Background: Despite research supporting the use of care coordination in chronic obstructive pulmonary disease (COPD), there is relatively little known about the comparative effectiveness of different strategies used to organize care for patients. To investigate the most important COPD care coordination strategies, community-based stakeholder input is needed, especially from medically underserved populations. Web-based platforms are electronic tools now being used to bring together individuals from underrepresented populations to share input and obtain clarification on comparative effectiveness research (CER) ideas, questions, and hypotheses. Objective: Use low computer-literate, collaborative survey technology to evaluate stakeholder priorities for CER in COPD care coordination. Methods: A mixed-method, concurrent triangulation design was used to collect survey data from a virtual advisory board of community-based stakeholders including medically underserved patients with COPD, informal caregivers, clinicians, and research scientists. The eDelphi method was used to conduct 3 iterative rounds of Web-based surveys. In the first 2 survey rounds, panelists viewed a series of “mini research prospectus” YouTube video presentations and rated their level of agreement with the importance of 10 COPD care coordination topics using 7-point Likert scales. In the final third-round survey, panelists ranked (1=most important, 8=least important) and commented on 8 remaining topics that panelists favored most throughout the first 2 survey rounds. Following the third-round survey, panelists were asked to provide feedback on the potential impact of a Web-based stakeholder engagement network dedicated to improving CER in COPD. Results: Thirty-seven panelists rated the following care coordination topics as most important (lower means indicate greater importance): (1) measurement of quality of care (mean 2.73, SD 1.95); (2) management of COPD with other chronic health issues (mean 2.92, SD 1.67); (3) pulmonary rehabilitation as a model for care (mean 3.72; SD 1.93); (4) quality of care coordination (mean 4.12, SD 2.41); and (5) comprehensive COPD patient education (mean 4.27, SD 2.38). Stakeholder comments on the relative importance of these care coordination topics primarily addressed the importance of comparing strategies for COPD symptom management and evaluating new methods for patient-provider communication. Approximately one half of the virtual panel assembled indicated that a Web-based stakeholder engagement network could enable more online community meetings (n=19/37, 51%) and facilitate more opportunities to suggest, comment on, and vote for new CER ideas in COPD (n=18/37, 49%). Conclusions: Members of this unique virtual advisory board engaged in a structured Web-based communication process that identified the most important community-specific COPD care coordination research topics and questions. Findings from this study support the need for more CER that evaluates quality of care measures used to assess the delivery of treatments and interventions among medically underserved patients with COPD.

  • LOVED in use. (cc) Sieverdes et al. CC-BY-SA 2.0, please cite as (http://www.researchprotocols.org/article/viewFile/3715/1/58741).

    Patient-Centered mHealth Living Donor Transplant Education Program for African Americans: Development and Analysis

    Abstract:

    Background: There is a critical need to expand the pool of available kidneys for African Americans who are on the transplant wait-list due to the disproportionally lower availability of deceased donor kidneys compared with other races/ethnic groups. Encouraging living donation is one method to fill this need. Incorporating mHealth strategies may be a way to deliver educational and supportive services to African American transplant-eligible patients and improve reach to those living in remote areas or unable to attend traditional group-session-based programs. Before program development, it is essential to perform formative research with target populations to determine acceptability and cultivate a patient-centered and culturally relevant approach to be used for program development. Objective: The objectives of this study were to investigate African American kidney transplant recipients’ and kidney donors’/potential donors’ attitudes and perceptions toward mobile technology and its viability in an mHealth program aimed at educating patients about the process of living kidney donation. Methods: Using frameworks from the technology acceptance model and self-determination theory, 9 focus groups (n=57) were administered to African Americans at a southeastern medical center, which included deceased/living donor kidney recipients and living donors/potential donors. After a demonstration of a tablet-based video education session and explanation of a group-based videoconferencing session, focus groups examined members’ perceptions about how educational messages should be presented on topics pertaining to the process of living kidney donation and the transplantation. Questionnaires were administered on technology use and perceptions of the potential program communication platform. Transcripts were coded and themes were examined using NVivo 10 software. Results: Qualitative findings found 5 major themes common among all participants. These included the following: (1) strong support for mobile technology use; (2) different media formats were preferred; (3) willingness to engage in video chats, but face-to-face interaction sometimes preferred; (4) media needs to be user friendly; (5) high prevalence of technology access. Our results show that recipients were willing to spend more time on education than the donors group, they wanted to build conversation skills to approach others, and preferred getting information from many sources, whereas the donor group wanted to hear from other living donors. The questionnaires revealed 85% or more of the sample scored 4+ on a 5-point Likert scale, which indicates high degree of interest to use the proposed program, belief that other mHealth technologies would help with adherence to medical regimens, and doctors would make regimen adjustments quicker. In addition, high utilization of mobile technology was reported; 71.9% of the participants had a mobile phone and 43.9% had a tablet. Conclusions: Our study supports the use of an mHealth education platform for African Americans to learn about living donation. However, potential recipients and potential donors have differing needs, and therefore, programs should be tailored to each target audience.

  • Another Version of Person Browsing the Internet (image source pexels.com).

    Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    Abstract:

    Background: Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective: The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods: A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results: Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients completed questionnaires. Low specificity of the resources to one’s condition and time poorness may have been barriers to engagement. Conclusions: Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound.

  • AutoVAR screenshot.

    Ecological Momentary Assessments and Automated Time Series Analysis to Promote Tailored Health Care: A Proof-of-Principle Study

    Abstract:

    Background: Health promotion can be tailored by combining ecological momentary assessments (EMA) with time series analysis. This combined method allows for studying the temporal order of dynamic relationships among variables, which may provide concrete indications for intervention. However, application of this method in health care practice is hampered because analyses are conducted manually and advanced statistical expertise is required. Objective: This study aims to show how this limitation can be overcome by introducing automated vector autoregressive modeling (VAR) of EMA data and to evaluate its feasibility through comparisons with results of previously published manual analyses. Methods: We developed a Web-based open source application, called AutoVAR, which automates time series analyses of EMA data and provides output that is intended to be interpretable by nonexperts. The statistical technique we used was VAR. AutoVAR tests and evaluates all possible VAR models within a given combinatorial search space and summarizes their results, thereby replacing the researcher’s tasks of conducting the analysis, making an informed selection of models, and choosing the best model. We compared the output of AutoVAR to the output of a previously published manual analysis (n=4). Results: An illustrative example consisting of 4 analyses was provided. Compared to the manual output, the AutoVAR output presents similar model characteristics and statistical results in terms of the Akaike information criterion, the Bayesian information criterion, and the test statistic of the Granger causality test. Conclusions: Results suggest that automated analysis and interpretation of times series is feasible. Compared to a manual procedure, the automated procedure is more robust and can save days of time. These findings may pave the way for using time series analysis for health promotion on a larger scale. AutoVAR was evaluated using the results of a previously conducted manual analysis. Analysis of additional datasets is needed in order to validate and refine the application for general use.

  • Home page of the iFightDepression tool.

    Depression Awareness and Self-Management Through the Internet: Protocol for an Internationally Standardized Approach

    Abstract:

    Background: Depression incurs significant morbidity and confers increased risk of suicide. Many individuals experiencing depression remain untreated due to systemic and personal barriers to care. Guided Internet-based psychotherapeutic programs represent a promising means of overcoming such barriers and increasing the capacity for self-management of depression. However, existing programs tend to be available only in English and can be expensive to access. Furthermore, despite evidence of the effectiveness of a number of Internet-based programs, there is limited evidence regarding both the acceptability of such programs and feasibility of their use, for users and health care professionals. Objective: This paper will present the protocol for the development, implementation, and evaluation of the iFightDepression tool, an Internet-based self-management tool. This is a cost-free, multilingual, guided, self-management program for mild to moderate depression cases. Methods: The Preventing Depression and Improving Awareness through Networking in the European Union consortium undertook a comprehensive systematic review of the available evidence regarding computerized cognitive behavior therapy in addition to a consensus process involving mental health experts and service users to inform the development of the iFightDepression tool. The tool was implemented and evaluated for acceptability and feasibility of its use in a pilot phase in 5 European regions, with recruitment of users occurring through general practitioners and health care professionals who participated in a standardized training program. Results: Targeting mild to moderate depression, the iFightDepression tool is based on cognitive behavioral therapy and addresses behavioral activation (monitoring and planning daily activities), cognitive restructuring (identifying and challenging unhelpful thoughts), sleep regulation, mood monitoring, and healthy lifestyle habits. There is also a tailored version of the tool for young people, incorporating less formal language and additional age-appropriate modules on relationships and social anxiety. The tool is accompanied by a 3-hour training intervention for health care professionals. Conclusions: It is intended that the iFightDepression tool and associated training for health care professionals will represent a valuable resource for the management of depression that will complement existing resources for health care professionals. It is also intended that the iFightDepression tool and training will represent an additional resource within a multifaceted approach to improving the care of depression and preventing suicidal behavior in Europe.

  • Study areas in the district of KaMpfumu, Maputo. Source: Ministry of Land and Urban Planning.

    Street Food Environment in Maputo (STOOD Map): a Cross-Sectional Study in Mozambique

    Abstract:

    Background: Street food represents a cultural, social, and economic phenomenon that is typical of urbanized areas, directly linked with a more sedentary lifestyle and providing a very accessible and inexpensive source of nutrition. Food advertising may contribute to shaping consumers’ preferences and has the potential to drive the supply of specific foods. Objective: The purpose of this study is to characterize the street food offerings available to the urban population of Maputo, the capital city of Mozambique, and the billboard food advertising in the same setting. Methods: People selling ready-to-eat foods, beverages, or snacks from venues such as carts, trucks, stands, and a variety of improvised informal setups (eg, shopping carts, trunks of cars, sides of vans, blankets on the sidewalk, etc) will be identified in the district of KaMpfumu. We will gather information about the actual food being sold through direct observation and interviews to vendors, and from the billboard advertising in the same areas. A second phase of the research entails collecting food samples to be analyzed in a specialized laboratory. The street food environment will be characterized, overall and according to socioeconomic and physical characteristics of the neighborhood, using descriptive statistics and spatial analysis. The study protocol was approved by the National Committee for Bioethics for Health in Mozambique. Results: Data collection, including the identification of street food vending sites and billboard advertising, started on October 20, 2014, and lasted for 1 month. The collection of food samples took place in December 2014, and the bromatological analyses are expected to be concluded in August 2015. Conclusions: The district of KaMpfumu is the wealthiest and most urbanized in Maputo, and it is the area with the highest concentration and variety of street food vendors. The expected results may yield important information to assess the nutritional environment and the characteristics of the foods to which a great majority of the urban population living or working in Maputo are exposed. Furthermore, this study protocol provides a framework for a stepwise standardized characterization of the street food environment, comprising 3 steps with increasing complexity and demand for human and technical resources: Step 1 consists of the evaluation of food advertising in the streets; Step 2 includes the identification of street food vendors and the characterization of the products available; and Step 3 requires the collection of food samples for bromatological analyses. This structured approach to the assessment of the street food environment may enable within-country and international comparisons as well as monitoring of temporal trends.

  • Untitled.

    The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol

    Abstract:

    Background: The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location Objective: This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients. Methods: A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion, as well as implementation feasibility will be conducted. Results: This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia. Conclusions: This is the first known trial of an automated, self-guided, Web-based support program that uses a holistic approach in targeting both type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations. Trial Registration: Australian and New Zealand Clinical Trials Registration number: ACTRN12612000620820; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000620820 (Archived by WebCite at http://www.webcitation.org/6a3BeXC5m).

  • This diagram in the questionnaire shows respondents how to measure the length of their index and ring fingers. Below the question, boxes are provided (not shown) for respondents to select the measurements from a drop-down menu.

    Designing an Internationally Accessible Web-Based Questionnaire to Discover Risk Factors for Amyotrophic Lateral Sclerosis: A Case-Control Study

    Abstract:

    Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a typical survival of three to five years. Epidemiological studies using paper-based questionnaires in individual countries or continents have failed to find widely accepted risk factors for the disease. The advantages of online versus paper-based questionnaires have been extensively reviewed, but few online epidemiological studies into human neurodegenerative diseases have so far been undertaken. Objective: To design a Web-based questionnaire to identify environmental risk factors for ALS and enable international comparisons of these risk factors. Methods: A Web-based epidemiological questionnaire for ALS has been developed based on experience gained from administering a previous continent-wide paper-based questionnaire for this disease. New and modified questions have been added from our previous paper-based questionnaire, from literature searches, and from validated ALS questionnaires supplied by other investigators. New criteria to allow the separation of familial and sporadic ALS cases have been included. The questionnaire addresses many risk factors that have already been proposed for ALS, as well as a number that have not yet been rigorously examined. To encourage participation, responses are collected anonymously and no personally identifiable information is requested. The survey is being translated into a number of languages which will allow many people around the world to read and answer it in their own language. Results: After the questionnaire had been online for 4 months, it had 379 respondents compared to only 46 respondents for the same initial period using a paper-based questionnaire. The average age of the first 379 web questionnaire respondents was 54 years compared to the average age of 60 years for the first 379 paper questionnaire respondents. The questionnaire is soon to be promoted in a number of countries through ALS associations and disease registries. Conclusions: Web-based questionnaires are a time- and resource-efficient method for performing large epidemiological studies of neurodegenerative diseases such as ALS. The ability to compare risk factors between different countries using the same analysis tool will be of particular value for finding robust risk factors that underlie ALS.

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  • Online Tobacco Cessation Training & Competency Assessment for CAM Practitioners: Protocol for the CAM Reach Web Study

    Date Submitted: Aug 21, 2015

    Open Peer Review Period: Aug 23, 2015 - Sep 6, 2015

    Despite development of relapse prevention intervention s ranging in intensity from extended counseling and/or pharmacotherapy to minimal interventions (e.g. mailed booklets), overall long-term success...

    Despite development of relapse prevention intervention s ranging in intensity from extended counseling and/or pharmacotherapy to minimal interventions (e.g. mailed booklets), overall long-term success rates of smoking quit attempts remains low. To date, relapse prevention interventions have focused on the newly abstinent smoker (“abstainer”), and not attempted to directly or indirectly influence the abstainer’s personal network, e .g. by helping the abstainer influence others in their personal network to quit. Personal networks (PNs) have powerful effects on initiating and maintaining smoking behavior and they also have great potential to facilitate smoking cessation. A “reach out and help others” intervention that seeks to increase the abstainer’s ability to influence smokers in their PN to quit – thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. Possible mechanisms include: 1) encouraging public commitment to abstinence (within PN); 2) creating cognitive dissonance with resuming smoking; 3) reinforcing/consolidating learning of cessation benefits/effective aids (through teaching others); 4) maintaining engagement with the quit attempt (through helping others quit); 5) providing additional or alternative strategies for coping with smokers in the social environment, and 6) shifting the PN’s norms toward smoking abstinence. The Helpers Program (“Helpers”) is an existing on-line tobacco cessation brief intervention ( BI ) training program that teaches lay community members how to help tobacco users quit through a non-confrontational “helping conversation” (BI). The Helpers approach emphasizes active listening and motivational communication skills to encourage quitting – with particular attention given to avoiding confrontation and nagging, reinforcing motivations for quitting, and encouraging use of effective cessation aids (e.g. quit lines, cessation medications). We propose to test the feasibility and acceptability of Helpers as a relapse prevention intervention with these Specific Aims: 1) Modify the Helpers Program website for use as a pilot relapse prevention intervention with new abstainers completing the Arizona Smokers’ Helpline ( ASH ) telephone based tobacco cessation program; 2) Conduct an observational feasibility pilot study with 120 abstainers (30-day abstinent) to examine: a) feasibility of recruiting and retaining participants in the study, b) participant initiation and completion of Helpers training, c) self-reported delivery of BIs to other tobacco users, and d) the number , timing, and duration of participants’ lapses/relapses to smoking; and 3) Conduct a social network analysis (SNA) pilot feasibility study with the same 120 abstainers to examine feasibility and acceptability of SNA methods, and various PN parameters needed to design a full-scale SNA study assessing effects of Helpers on PNs, including: a) recruitment and retention of newly abstinent smokers, b) changes in participants’ PNs over course of the study (size, composition, structure, number of current/former smokers), c) presence or absence, effect and spread of smoking cessation related information and behaviors within PNs.

  • Social Network Support and Cancer: Study protocol for the Cancer-PEPSONE study - a randomized controlled study on optimizing social network support to families living with parental cancer.

    Date Submitted: Aug 19, 2015

    Open Peer Review Period: Aug 19, 2015 - Sep 2, 2015

    Background: Parental cancer can have a significant impact on a family's psychosocial functioning and quality of life, whereby the children’s situation is strongly related to parental coping and capa...

    Background: Parental cancer can have a significant impact on a family's psychosocial functioning and quality of life, whereby the children’s situation is strongly related to parental coping and capacity. Such parents ask for more help in order to increase their care capacity, while the network is often insecure about how to help and thereby withdraw. They ask for guidance and training to be able to support cancer families. Based on this, the Cancer-PEPSONE study was developed. Objective: To optimize social network support through a psycho-educational program for families living with parental cancer and their network members in order to increase parental capacity and thereby secure the children’s safety and quality of life. Methods: The Cancer-PEPSONE study is conducted as an RCT-study in which 60 families living with parental cancer are randomized to either an intervention group or control group. The intervention lasts for three hours and is titled as follows: 1) Introduction, 2) Psycho-education: living with cancer in the family and the importance of social network support, and 3) Discussion: this family’s need for social support. Primary outcomes are social support, mental health and quality of life, and secondary outcomes are resilience and parental capacity. Data is collected by a set of questionnaires distributed to healthy parents living with a partner with cancer, one child in the family and network members of the intervention families at inclusion, and after three and six months. Results: This paper presents the Cancer-PEPSON study’s protocol in order to give a broader understanding of the background and content of the program. The study is ongoing until August 2016, and the first results are anticipated to be finished by November 2015. Conclusions: We anticipate that the results from the Cancer-PEPSONE study will provide important knowledge that is useful for clinical practice and further research. Based on the results, the Cancer-PEPSONE study will be implemented in the local healthcare system in Norway. Clinical Trial: ISRCTN15982171

  • How focus group methodology can inform recruitment into a longitudinal women’s health survey.

    Date Submitted: Aug 11, 2015

    Open Peer Review Period: Aug 17, 2015 - Aug 31, 2015

    Background: Recruiting and retention of participants to large-scale longitudinal studies can be a challenge, particularly when trying to target young women. Qualitative inquiries with members of the t...

    Background: Recruiting and retention of participants to large-scale longitudinal studies can be a challenge, particularly when trying to target young women. Qualitative inquiries with members of the target population can prove valuable in assisting with the development of effective recruiting techniques. Researchers in the current study made use of focus group methodology to identify how to encourage young women aged 18-23 to participate in a national cohort online survey. Objective: To gain insight into how to encourage young women to participate in a large scale, longitudinal health survey. To evaluate the survey instrument and mode of administration. Methods: The Australian Longitudinal Study on Women’s Health used focus group methodology to learn how to encourage young women to participate in a large scale, longitudinal web-based health survey, and to evaluate the survey instrument and mode of administration. Nineteen groups, involving 75 women aged 18-23 years, were held in rural and urban areas of New South Wales and Queensland. Results: The focus groups allowed concord to be reached regarding survey promotion using social media, why personal information was needed, strategies to ensure confidentiality, how best to ask sensitive questions and survey design for ease of completion. Conclusions: Intense recruitment efforts and variation in final focus group numbers highlights the ‘hard to reach’ character of young women. However, the benefits of conducting focus group discussions as a preparatory stage to the recruitment of a large cohort for a longitudinal web-based health survey were upheld.

  • Understanding user reactions and interactions with an internet-based intervention for tinnitus self-management: A mixed methods process evaluation protocol

    Date Submitted: Aug 7, 2015

    Open Peer Review Period: Aug 17, 2015 - Aug 31, 2015

    Background: Tinnitus is a common medical symptom that can affect an individual’s emotional and functional quality of life. Psychological therapies are acknowledged as beneficial to people with tinni...

    Background: Tinnitus is a common medical symptom that can affect an individual’s emotional and functional quality of life. Psychological therapies are acknowledged as beneficial to people with tinnitus, however, they are not always readily accessible. With their global reach, internet-based interventions have the potential to reduce the disparity in access to psychological support which people with tinnitus currently experience. Objective: This research will explore past, current and new users’ reactions to and interactions with the Tinnitus E-Programme, an internet-based intervention for the self-management of tinnitus. Methods: Two parallel mixed methods studies will be carried out with two different populations. Study 1 will use an online survey to gather past and current users’ views of the programme. Study 2 will recruit new programme users to take part in an interview and complete a relaxation log to explore how well they were able to implement the skills they learnt during the programme in their everyday lives. Results: The findings from both studies will be triangulated to develop an in-depth understanding of the programme’s mechanisms of impact and identify any implementation or contextual factors that strengthen or impede its delivery and functioning. Conclusions: Findings will inform the optimisation of the Tinnitus E-Programme and guide future evaluation work to assess the programme’s effectiveness as a therapy for people with tinnitus.

  • Privacy preserving medical information sharing in cloud environment

    Date Submitted: Aug 5, 2015

    Open Peer Review Period: Aug 17, 2015 - Aug 31, 2015

    Background: Patient Health Records (PHRs) shift the ownership of health data from caregiver to patients. However, such a shift poses important challenges from the data privacy point of view in the clo...

    Background: Patient Health Records (PHRs) shift the ownership of health data from caregiver to patients. However, such a shift poses important challenges from the data privacy point of view in the cloud environment. Current PHR systems partially fail to convince patients to rely on a third party for managing their private health data. Objective: This paper reviews the research literature on attributed-based cryptographies and medical privacy requirements, with the aim to leverage patient concerns and present a secure cloud-based PHR system. The proposed CPPHR (cloud-based privacy preserving PHR) system is designed with the objectives: data source verifiability, patient privacy preserving, fine-grained and high-efficient access control. Methods: The PHRs are collected from multiple sources, and some of these records are sensitive or private. To enable hierarchical data security, a PHR tree is constructed with nodes that each presents a single record (leaf node) or a physical meaningful combination of records set (internal nodes). Based on this PHR tree, three attribute-based cryptographic methods (signature, encryption and signcryption) are applied for fine-grained access control, corresponding to the data security levels. The users are categorized into public domains and private domains, as well as emergent domain, thus to access data if satisfying the domain-based attributes and identity constraints. Results: From security aspect of view, CPPHR system is proved secure against collusion attacks. Also, the privacy laws and user concerns are satisfied via proofing the system security features of correctness, unforgeability and indistinguishability. On the other hand, the performance evaluations show that the sharing of hierarchical data is much more efficient in CPPHR system compared with existing researches. Besides, the suggested attribute-based signcryption (ABSC) scheme performs superior in computation and communication overheads “cost[ABSC] < cost[KP-ABE] + cost[ABS]”, as simulated in various of conditions. Conclusions: The proposed CPPHR system is superior in both security and efficiency. Patients are enabled to have full control over their own PHRs without relying on third parties, and legal users with satisfiable attributes and identities may have quick access to data in separated user domains. Moreover, break glass access for emergency institutions is achieved via a temporary secure channel, thus to provide first aid and revoke soon after the accident. Further work is to develop mobile Apps and extend interfaces to multiple data sources.

  • SIDEAL: Innovative support to the alcohol dependent patient (Soporte Innovador al paciente con DEpendencia al ALcohol). Protocol for the development, validation and implementation of a mobile app for the management of alcohol dependence.

    Date Submitted: Aug 3, 2015

    Open Peer Review Period: Aug 17, 2015 - Aug 31, 2015

    Background: Information and communication technologies (ICT) have become one of the main pathways to the new paradigm of increased self-management of chronic conditions, such as alcohol dependence. So...

    Background: Information and communication technologies (ICT) have become one of the main pathways to the new paradigm of increased self-management of chronic conditions, such as alcohol dependence. Some mobile phone applications have started to be validated, with many others on the way. Objective: Here we describe the protocol for the validation of a new app, named SIDEAL. Methods: The project consists of three complementary, consecutive studies, including a pilot, feasibility study, a focus group, qualitative study, and finally a randomized controlled trial embedded in a phase-IV study of nalmefene, where patients will be randomized to treatment as usual or treatment as usual plus SIDEAL. During the pilot study, feasibility, usability and acceptance by users will be the main outcomes explored. An electronic questionnaire will be sent to patients asking for their opinion. Focus groups will be the next step, where improvements and refinements will be implemented to the app. Finally, during the final phase, consumption variables [heavy drinking days per month, standard drinks per week] will be investigated, in order to test the efficacy of the app. Results: given that recent publications show encouraging results, we expect patients to widely accept and incorporate SIDEAL to their therapeutic options. Significant reductions in drinking-related variables are also expected. Conclusions: SIDEAL might offer a useful, reliable, efficacious and efficient tool to the therapeutic options of both patients and professionals.

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