JMIR Publications

JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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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 2015: 4.532)

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)

 
 

Recent Articles:

  • A Pilot Study of Technology-Enabled Co-Production in Pediatric Chronic Illness Care. Source: JMIR Research Protocols; Copyright: The Authors; URL: https://www.researchprotocols.org/; License: Creative Commons Attribution (CC-BY).

    Protocol of a Pilot Study of Technology-Enabled Coproduction in Pediatric Chronic Illness Care

    Abstract:

    Background: Pediatric chronic illness care models are traditionally organized around acute episodes of care and may not meet the needs of patients and their families. Interventions that extend the patient-clinician interaction beyond the health care visit, allow for asynchronous and bidirectional feedback loops that span visits and daily life, and facilitate seamless sharing of information are needed to support a care delivery system that is more collaborative, continuous, and data-driven. Orchestra is a mobile health technology platform and intervention designed to transform the management of chronic diseases by optimizing patient-clinician coproduction of care. Objective: The aim of this study is to assess the feasibility, acceptability, and preliminary impact of the Orchestra technology and intervention in the context of pediatric chronic illness care. Methods: This study will be conducted in the cystic fibrosis and inflammatory bowel disease clinics at Cincinnati Children’s Hospital Medical Center. We will enroll interested patients and their caregivers to work with clinicians to use the Orchestra technology platform and care model over a 6-month period. In parallel, we will use quality improvement methods to improve processes for integrating Orchestra into clinic workflows and patient/family lifestyles. We will use surveys, interviews, technology use data, and measures of clinical outcomes to assess the feasibility, acceptability, and preliminary impact of Orchestra. Outcome measures will include assessments of: (1) enrollment and dropout rates; (2) duration of engagement/sustained use; (3) symptom and patient-reported outcome tracker completion rates; (4) perceived impact on treatment plan, communication with the clinical team, visit preparation, and overall care; (5) changes in disease self-efficacy and engagement in care; and (6) clinical outcomes and health care utilization. Results: Participant recruitment began in mid-2015, with results expected in 2017. Conclusions: Chronic disease management needs a dramatic transformation to support more collaborative, effective, and patient-centered care. This study is unique in that it is testing not only the impact of technology, but also the necessary processes that facilitate patient and clinician collaboration. This pilot study is designed to examine how technology-enabled coproduction can be implemented in real-life clinical contexts. Once the Orchestra technology and intervention are optimized to ensure feasibility and acceptability, future studies can test the effectiveness of this approach to improve patient outcomes and health care value.

  • Source: iStock by Getty Images; Copyright: kali9; URL: http://www.istockphoto.com/ca/photo/hand-of-nurse-giving-patient-medication-gm185066135-18888749; License: Licensed by the authors.

    Association Between Workarounds and Medication Administration Errors in Bar Code-Assisted Medication Administration: Protocol of a Multicenter Study

    Abstract:

    Background: Information technology-based methods such as bar code-assisted medication administration (BCMA) systems have the potential to reduce medication administration errors (MAEs) in hospitalized patients. In practice, however, systems are often not used as intended, leading to workarounds. Workarounds may result in MAEs that may harm patients. Objective: The primary aim is to study the association of workarounds with MAEs in the BCMA process. Second, we will determine the frequency and type of workarounds and MAEs and explore the potential risk factors (determinants) for workarounds. Methods: This is a multicenter prospective study on internal medicine and surgical wards of 4 Dutch hospitals using BCMA systems to administer medication. We will include a total of 6000 individual drug administrations using direct observation to collect data. Results: The project was funded in 2014 and enrollment was completed at the end of 2016. Data analysis is under way and the first results are expected to be submitted for publication at the end of 2017. Conclusions: If an association between workarounds and MAEs is established, this information can be used to reduce the frequency of MAEs. Information on determinants of workarounds can aid in a focused approach to reduce workarounds and thus increase patient safety. Trial Registration: Netherlands Trial Register NTR4355; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4355 (Archived by WebCite at http://www.webcitation.org/6pqTLxc6i).

  • Picture taken for Parent Project Muscular Dystrophy. Source: Rick Guidotti with Positive Exposure, Mother of Pearls Project; Copyright: Rick Guidotti; URL: http://positiveexposure.org/; License: Permission acquired by the authors..

    Engaging Patients and Caregivers Managing Rare Diseases to Improve the Methods of Clinical Guideline Development: A Research Protocol

    Abstract:

    Background: Clinical guidelines provide systematically developed recommendations for deciding on appropriate health care options for specific conditions and clinical circumstances. Up until recently, patients and caregivers have rarely been included in the process of developing care guidelines. Objective: This project will develop and test a new online method for including patients and their caregivers in this process using Duchenne muscular dystrophy (DMD) care guidelines as an example. The new method will mirror and complement the RAND/UCLA Appropriateness Method (RAM)—the gold standard approach for conducting clinical expert panels that uses a modified Delphi format. RAM is often used in clinical guideline development to determine care appropriateness and necessity in situations where existing clinical evidence is uncertain, weak, or unavailable. Methods: To develop the new method for engaging patients and their caregivers in guideline development, we will first conduct interviews with experts on RAM, guideline development, patient engagement, and patient-centeredness and engage with Duchenne patients and caregivers to identify how RAM should be modified for the purposes of patient engagement and what rating criteria should patients and caregivers use to provide their input during the process of guideline development. Once the new method is piloted, we will test it by conducting two concurrently run patient/caregiver panels that will rate patient-centeredness of a subset of DMD care management recommendations already deemed clinically appropriate and necessary. The ExpertLens™ system—a previously evaluated online modified Delphi system that combines two rounds of rating with a round of feedback and moderated online discussions—will be used to conduct these panels. In addition to developing and testing the new engagement method, we will work with the members of our project’s Advisory Board to generate a list of best practices for enhancing the level of patient and caregiver involvement in the guideline development process. We will solicit input on these best practice from Duchenne patients, caregivers, and clinicians by conducting a series of round-table discussions and making a presentation at an annual conference on Duchenne. Results: The study protocol was reviewed by RAND’s Human Subjects Protection Committee, which determined it to be exempt from review. Interviews with RAM experts have been completed. The projected study completion date is May 2020. Conclusions: We expect that the new method will make it easier to engage large numbers of patients and caregivers in the process of guideline development in a rigorous and culturally appropriate manner that is consistent with the way clinicians participate in guideline development. Moreover, this project will develop best practices that could help involve patients and caregivers in the clinical guideline development process in other clinical areas, thereby facilitating the work of guideline developers.

  • Example of a data collection setup in an outpatient consultation room. Source: Vincent Blijleven; Copyright: The Authors; URL: http://www.vincentblijleven.com/wp-content/uploads/2017/03/ToC-Image.jpg; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Exploring Workarounds Related to Electronic Health Record System Usage: A Study Protocol

    Abstract:

    Background: Health care providers resort to informal temporary practices known as workarounds for handling exceptions to normal workflow that are unintentionally imposed by electronic health record (EHR) systems. Although workarounds may seem favorable at first sight, they are generally suboptimal and may jeopardize patient safety, effectiveness, and efficiency of care. Identifying workarounds and understanding their motivations, scope, and impact is pivotal to support the design of user-friendly EHRs and achieve closer alignment between EHRs and work contexts. Objective: We propose a study protocol to identify EHR workarounds and subsequently determine their scope and impact on health care providers’ workflows, patient safety, effectiveness, and efficiency of care. First, knowing whether a workaround solely affects the health care provider who devised it, or whether its effects extends beyond the EHR user to the work context of other health care providers, is key to accurately assessing its degree of influence on the overall patient care workflow. Second, knowing whether the consequence of an EHR workaround is favorable or unfavorable provides insights into how to address EHR-related safety, effectiveness, and efficiency concerns. Knowledge of both perspectives can provide input on optimizing EHR designs. Methods: In the study, a combination of direct observations, semistructured interviews, and qualitative coding techniques will be used to identify, analyze, and classify EHR workarounds. The research project will be conducted within three distinct pediatric care processes and settings at a large university hospital. Results: Data was collected using the described approach from January 2016 to March 2017. Data analysis is underway and is expected to be completed in May 2017. We aim to report the results of this study in a follow-up publication. Conclusions: This study protocol provides a grounded framework to explore EHR workarounds from a holistic and integral perspective. Insights from this study can inform the design and redesign of EHRs to further align with work contexts of healthcare professionals, and subsequently lead to better organization and safer provision of care.

  • Screen shot of a webpage from TAVIE en m@rche. Not yet publicly available online. Copyright: Tavie en m@arche;

    Evaluation of a Web-Based Tailored Nursing Intervention (TAVIE en m@rche) Aimed at Increasing Walking After an Acute Coronary Syndrome: A Multicenter...

    Abstract:

    Background: Despite the health benefits of increasing physical activity in the secondary prevention of acute coronary syndrome (ACS), up to 60% of ACS patients are insufficiently active. Evidence supporting the effect of Web-based interventions on increasing physical activity outcomes in ACS patients is growing. However, randomized controlled trials (RCTs) using Web-based technologies that measured objective physical activity outcomes are sparse. Objective: Our aim is to evaluate in insufficiently active ACS patients, the effect of a fully automated, Web-based tailored nursing intervention (TAVIE en m@rche) on increasing steps per day. Methods: A parallel two-group multicenter RCT (target N=148) is being conducted in four major teaching hospitals in Montréal, Canada. An experimental group receiving the 4-week TAVIE en m@rche intervention plus a brief “booster” at 8 weeks, is compared with the control group receiving hyperlinks to publicly available websites. TAVIE en m@rche is based on the Strengths-Based Nursing Care orientation to nursing practice and the Self-Determination Theory of human motivation. The intervention is centered on videos of a nurse who delivers the content tailored to baseline levels of self-reported autonomous motivation, perceived competence, and walking behavior. Participants are recruited in hospital and are eligible if they report access to a computer and report less than recommended physical activity levels 6 months before hospitalization. Most outcome data are collected online at baseline, and 5 and 12 weeks postrandomization. The primary outcome is change in accelerometer-measured steps per day between randomization and 12 weeks. The secondary outcomes include change in steps per day between randomization and 5 weeks, and change in self-reported energy expenditure for walking and moderate to vigorous physical activity between randomization, and 5 and 12 weeks. Theoretical outcomes are the mediating role of self-reported perceived autonomy support, autonomous and controlled motivations, perceived competence, and barrier self-efficacy on steps per day. Clinical outcomes are quality of life, smoking, medication adherence, secondary prevention program attendance, health care utilization, and angina frequency. The potential moderating role of sex will also be explored. Analysis of covariance models will be used with covariates such as sex, age, fatigue, and depression symptoms. Allocation sequence is concealed, and blinding will be implemented during data analysis. Results: Recruitment started March 30, 2016. Data analysis is planned for November 2017. Conclusions: Finding alternative interventions aimed at increasing the adoption of health behavior changes such as physical activity in the secondary prevention of ACS is clearly needed. Our RCT is expected to help support the potential efficacy of a fully automated, Web-based tailored nursing intervention on the objective outcome of steps per day in an ACS population. If this RCT is successful, and after its implementation as part of usual care, TAVIE en m@rche could help improve the health of ACS patients at large. Trial Registration: ClinicalTrials.gov NCT02617641; https://clinicaltrials.gov/ct2/show/NCT02617641 (Archived by WebCite at http://www.webcitation.org/6pNNGndRa)

  • Fitbit Image. Source: Kohl's; Copyright: Kohl's; URL: https://www.google.com/aclk?sa=l&ai=DChcSEwjzv4Tur-XSAhUUan4KHbhlCfMYABALGgJwYw&sig=AOD64_33rvLd4UPrBKKTZ85OaBpaI5l0GA&ctype=5&q=&ved=0ahUKEwju5__tr-XSAhXHwVQKHaDzCdIQwg8IkgE&adurl=; License: Public Domain (CC0).

    Establishing Linkages Between Distributed Survey Responses and Consumer Wearable Device Datasets: A Pilot Protocol

    Abstract:

    Background: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as activity trackers to monitor their daily physical activity and other health-related goals. Researchers would benefit from learning more about the health of these individuals remotely, without meeting face-to-face with participants and avoiding the high cost of providing consumer wearables to participants for the study duration. Objective: The present study seeks to develop the methods to collect data remotely and establish a linkage between self-reported survey responses and consumer wearable device biometric data, ultimately producing a de-identified and linked dataset. Establishing an effective protocol will allow for future studies of large-scale deployment and participant management. Methods: A total of 30 participants who use a Fitbit will be recruited on Mechanical Turk Prime and asked to complete a short online self-administered questionnaire. They will also be asked to connect their personal Fitbit activity tracker to an online third-party software system, called Fitabase, which will allow access to 1 month’s retrospective data and 1 month’s prospective data, both from the date of consent. Results: The protocol will be used to create and refine methods to establish linkages between remotely sourced and de-identified survey responses on health status and consumer wearable device data. Conclusions: The refinement of the protocol will inform collection and linkage of similar datasets at scale, enabling the integration of consumer wearable device data collection in cross-sectional and prospective cohort studies.

  • Manual wheelchair user. Source: Pixabay.com; Copyright: Steve Buissinne; URL: https://pixabay.com/en/wheelchair-disability-injured-749985/; License: Public Domain (CC0).

    The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial

    Abstract:

    Background: Physical activity (PA) must be performed regularly to accrue health benefits. However, the majority of manual wheelchair users do not meet PA recommendations. Existing community-based PA programs for manual wheelchair users appear to work, but effect sizes are small and retention is low. Existing PA programs may not fully implement some psychosocial factors that are strongly linked with PA (eg, autonomy). The use of peers and mobile phone technology in the Smartphone Peer PA Counseling (SPPAC) program represents a novel approach to cultivating a PA-supportive environment for manual wheelchair users. Objective: The primary objective is to compare change in objective PA between the experimental (SPPAC) and control groups from baseline to postintervention (10 weeks) and follow-up (3 months). Changes in and relationships between subjective PA, wheelchair skills, motivation, self-efficacy (for overcoming barriers to PA for manual wheelchair use), satisfaction of psychological needs for PA, and satisfaction with PA participation will be explored (secondary outcome). Program implementation will be explored (tertiary objective). Methods: A total of 38 community-living manual wheelchair users (≥18 years) will be recruited in a randomized controlled trial (RCT). Participants in both the control and experimental groups will receive existing PA guidelines. Participants in the experimental group will also receive the SPPAC program: 14 sessions (~30 min) over a 10-week period delivered by a peer trainer using a mobile phone. PA activities will be based on individuals’ preferences and goals. Implementation of important theoretical variables will be enforced through a peer-trainer checklist. Outcomes for objective PA (primary) and subjective PA, wheelchair skills, motivation, self-efficacy, satisfaction of psychological needs, and satisfaction with participation will be collected at three time points (baseline, postintervention, follow-up). Multiple imputations will be used to treat missing data. A mixed-model ANCOVA will be conducted, controlling for covariates (primary and secondary objectives). The strength and direction of the relationships between the primary and secondary outcomes will be explored (secondary objective). Descriptive and content analysis will be used to appraise program implementation (tertiary objective). Results: Funding has been obtained from the Craig Neilsen Foundation and the Canadian Disability Participation Project, with additional funds being sought from the Canadian Institute for Health Research and Fonds de Recherche du Québec-Santé. Pilot evaluation of intervention implementation is currently underway, with enrollment anticipated to begin early 2018. Conclusions: There may be substantial benefits for the SPPAC program including limited burden on health care professionals, decreased barriers (eg. accessibility, transportation), development of peer social supports, and potential cost savings related to physical inactivity. Before conducting a large and expensive multisite RCT within a small heterogeneous population of manual wheelchair users, a pilot study affords a prudent step to establishing an adequate study protocol and implementation strategies. Trial Registration: ClinicalTrials.gov NCT02826707; https://clinicaltrials.gov/ct2/show/NCT02826707 (Archived by WebCite at http://www.webcitation.org/6pqIc14dU)

  • Screenshot of b@Ease Mindfulness App. in phone (montage). Source: PaceIt/Image of App created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/4/:e67/; License: Creative Commons Attribution (CC-BY).

    Evaluation of a Mindfulness-Based Mobile App Aimed at Promoting Awareness of Weight-Related Behaviors in Adolescents: A Pilot Study

    Abstract:

    Background: Mindfulness-based interventions are reported to be highly acceptable and have positive effects on youth, yet most are clinic- or school-based aimed at emotional regulation or academic performance. To provide flexible program delivery, we developed and tested a standalone mindfulness-based app aimed at improving weight-related behaviors (eg, diet, physical activity, sleep) in adolescents. Objective: Our objective was to assess the feasibility, acceptability, and utility of a mindfulness-based mobile app. Methods: In a single-arm pilot study, 15 adolescents (14-18 years) were prompted to access the app once a day, every day for 6 weeks. Outcomes were measured by in-app and poststudy surveys, and descriptive statistical analyses were performed. Time within a mindfulness state was self-reported during weekly timed practices. Results: The app was rated highly for content and encouraging the practice of activities to promote mindfulness states. Teens reported increased awareness of eating behaviors and high adherence, particularly during physically active practices. Average self-reported time spent in a mindfulness state increased 2.5 times by week 6 (78 [SD 17] seconds) compared to week 1 (31 [SD 21] seconds). Conclusions: The high acceptability and utility ratings of the app, increases in reported time in mindfulness states, and high frequency of participation, including mindful eating and physical activity, suggest the mindfulness-based mobile app has the potential to improve awareness of weight-related behaviors.

  • This is a screenshot of one of the training programs participants are playing in the intervention. Copyright: Posit Science; URL: www.brainhq.com; License: Creative Commons Attribution (CC-BY).

    Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and...

    Abstract:

    Background: HIV-associated neurocognitive disorders occur in nearly 50% of adults with HIV. Such disorders can interfere with everyday functioning such as driving and medication adherence. Therefore, cognitive interventions are needed to address such neurocognitive disorders as well as improve everyday functioning, especially as people age with HIV. Objective: This article reports and discusses the overall rationale and development of speed of processing training, a computerized Internet cognitive training program, to improve this specific neurocognitive ability as well as everyday functioning and quality of life in adults aging with HIV. Although this protocol has been shown to improve speed of processing, everyday functioning, and quality of life in healthy, community-dwelling older adults in the advanced cognitive training in vital elderly (ACTIVE) study, its efficacy in adults aging with HIV has not been established. Nevertheless, such a cognitive intervention is particularly germane as 52%-59% of adults with HIV experience HIV-associated neurocognitive disorders (HAND), and both the frequency and severity of such disorders may increase with advancing age. Methods: The description of this longitudinal randomized controlled trial covers the following: (1) rationale for speed of processing training in this clinical population, (2) overview of overall study design, (3) eligibility criteria and HAND, (4) intervention dosage, (5) assessment battery, and (6) examination of biomarkers. Results: The project was funded in April 2016 and enrolment is on-going. The first results are expected to be submitted for publication in 2020. Conclusions: Similar novel cognitive intervention approaches are suggested as they may be of value to those with HAND and may utilize similar features of this current randomized controlled trial (RCT) protocol to examine their therapeutic efficacy. Trial Registration: ClinicalTrials.gov NCT02758093; https://clinicaltrials.gov/ct2/show/NCT02758093 (Archived by Webcite at http://www.webcitation.org/6p8C5fBCX)

  • The HomeStyles Project. Copyright: The Authors; URL: http://www.researchprotocols.org/2017/4/e73/;

    HomeStyles, A Web-Based Childhood Obesity Prevention Program for Families With Preschool Children: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: The home environment is where young children spend most of their time, and is critically important to supporting behaviors that promote health and prevent obesity. However, the home environment and lifestyle patterns remain understudied, and few interventions have investigated parent-led makeovers designed to create home environments that are supportive of optimal child health and healthy child weights. Objective: The aim of the HomeStyles randomized controlled trial (RCT) is to determine whether the Web-based HomeStyles intervention enables and motivates parents to shape the weight-related aspects of their home environments and lifestyle behavioral practices (diet, exercise, and sleep) to be more supportive of their preschool children’s optimal health and weight. Methods: A rigorous RCT utilizing an experimental group and an attention control group, receiving a bona fide contemporaneous treatment equal in nonspecific treatment effects and differing only in subject matter content, will test the effect of HomeStyles on a diverse sample of families with preschool children. This intervention is based on social cognitive theory and uses a social ecological framework, and will assess: intrapersonal characteristics (dietary intake, physical activity level, and sleep) of parents and children; family interpersonal or social characteristics related to diet, physical activity, media use, and parental values and self-efficacy for obesity-preventive practices; and home environment food availability, physical activity space and supports in and near the home, and media availability and controls in the home. Results: Enrollment for this study has been completed and statistical data analyses are currently underway. Conclusions: This paper describes the HomeStyles intervention with regards to: rationale, the intervention’s logic model, sample eligibility criteria and recruitment, experimental group and attention control intervention content, study design, instruments, data management, and planned analyses.

  • SOMBRA (Skin health Online for Melanoma: Better Risk Assessment) Study Logo. Source: The Authors; Copyright: The Authors; URL: http://www.sombrastudy.org;

    Implementing an Internet-Delivered Skin Cancer Genetic Testing Intervention to Improve Sun Protection Behavior in a Diverse Population: Protocol for a...

    Abstract:

    Background: Limited translational genomic research currently exists to guide the availability, comprehension, and appropriate use of personalized genomics in diverse general population subgroups. Melanoma skin cancers are preventable, curable, common in the general population, and disproportionately increasing in Hispanics. Objective: Variants in the melanocortin-1 receptor (MC1R) gene are present in approximately 50% of the population, are major factors in determining sun sensitivity, and confer a 2-to-3-fold increase in melanoma risk in the general population, even in populations with darker skin. Therefore, feedback regarding MC1R risk status may raise risk awareness and protective behavior in the general population. Methods: We are conducting a randomized controlled trial examining Internet presentation of the risks and benefits of personalized genomic testing for MC1R gene variants that are associated with increased melanoma risk. We will enroll a total of 885 participants (462 participants are currently enrolled), who will be randomized 6:1 to personalized genomic testing for melanoma risk versus waiting list control. Control participants will be offered testing after outcome assessments. Participants will be balanced across self-reported Hispanic versus non-Hispanic ethnicity (n=750 in personalized genomic testing for melanoma risk arm; n=135 in control arm), and will be recruited from a general population cohort in Albuquerque, New Mexico, which is subject to year-round sun exposure. Baseline surveys will be completed in-person with study staff and follow-up measures will be completed via telephone. Results: Aim 1 of the trial will examine the personal utility of personalized genomic testing for melanoma risk in terms of short-term (3-month) sun protection and skin screening behaviors, family and physician communication, and melanoma threat and control beliefs (ie, putative mediators of behavior change). We will also examine potential unintended consequences of testing among those who receive average-risk personalized genomic testing for melanoma risk findings, and examine predictors of sun protection at 3 months as the outcome. These findings will be used to develop messages for groups that receive average-risk feedback. Aim 2 will compare rates of test consideration in Hispanics versus non-Hispanics, including consideration of testing pros and cons and registration of a decision to either accept or decline testing. Aim 3 will examine personalized genomic testing for melanoma risk feedback comprehension, recall, satisfaction, and cancer-related distress in those who undergo testing, and whether these outcomes differ by ethnicity (Hispanic vs non-Hispanic), or sociocultural or demographic factors. Final outcome data collection is anticipated to be complete by October 2017, at which point data analysis will commence. Conclusions: This study has important implications for personalized genomics in the context of melanoma risk, and may be broadly applicable as a model for delivery of personalized genomic feedback for other health conditions.

  • Malaria system microApp. Source: Smartmockups; Copyright: Gabe Will via Smartmockups; URL: http://smartmockups.com/mockup/digital_gabe_4; License: Creative Commons Attribution 2.0.

    The Malaria System MicroApp: A New, Mobile Device-Based Tool for Malaria Diagnosis

    Abstract:

    Background: Malaria is a public health problem that affects remote areas worldwide. Climate change has contributed to the problem by allowing for the survival of Anopheles in previously uninhabited areas. As such, several groups have made developing news systems for the automated diagnosis of malaria a priority. Objective: The objective of this study was to develop a new, automated, mobile device-based diagnostic system for malaria. The system uses Giemsa-stained peripheral blood samples combined with light microscopy to identify the Plasmodium falciparum species in the ring stage of development. Methods: The system uses image processing and artificial intelligence techniques as well as a known face detection algorithm to identify Plasmodium parasites. The algorithm is based on integral image and haar-like features concepts, and makes use of weak classifiers with adaptive boosting learning. The search scope of the learning algorithm is reduced in the preprocessing step by removing the background around blood cells. Results: As a proof of concept experiment, the tool was used on 555 malaria-positive and 777 malaria-negative previously-made slides. The accuracy of the system was, on average, 91%, meaning that for every 100 parasite-infected samples, 91 were identified correctly. Conclusions: Accessibility barriers of low-resource countries can be addressed with low-cost diagnostic tools. Our system, developed for mobile devices (mobile phones and tablets), addresses this by enabling access to health centers in remote communities, and importantly, not depending on extensive malaria expertise or expensive diagnostic detection equipment.

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  • Efficacy of Lactobacillus reuteri DSM 17938 for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial.

    Date Submitted: Apr 26, 2017

    Open Peer Review Period: Apr 26, 2017 - May 10, 2017

    Background: Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. However, despite proven efficacy, it remains underused. This i...

    Background: Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. However, despite proven efficacy, it remains underused. This is because oral rehydration solution neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness. Hence, there is interest in adjunctive treatments. According to the 2014 guidelines developed by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, the use of the following probiotics may be considered in the management of children with AGE in addition to rehydration therapy: Lactobacillus rhamnosus GG (low quality of evidence; strong recommendation) and Saccharomyces boulardii (low quality of evidence; strong recommendation). Less compelling evidence is available for Lactobacillus reuteri DSM 17938 (very low quality of evidence; weak recommendation). Considering that evidence on L reuteri remains limited, we aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Objective: To assess the effectiveness of L reuteri DSM 17938 in the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately. Methods: Methods and analysis: This will be a double-blind, placebo-controlled, randomised trial. Children between 1 and 60 months of age with AGE, defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form scale or Amsterdam Stool Form scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days, will be recruited. A total of 72 children will receive either L reuteri DSM 17938 108 colony-forming units (CFU) twice daily or matching placebo for 5 consecutive days. A similar sample size for rotavirus vaccinated and non-vaccinated children is planned. The primary outcome measure is the duration of diarrhoea. Results: NA Conclusions: NA Clinical Trial: The study protocol is under registration at ClinicalTrials.gov. NCT02989350.

  • ‘Train your Mind’: Enhancing Executive Functions among Elementary School Children: a Dutch randomized controlled trial intervention study protocol

    Date Submitted: Apr 24, 2017

    Open Peer Review Period: Apr 25, 2017 - May 9, 2017

    Background: Executive functions are higher cognitive control functions, consisting of working memory, cognitive flexibility, and impulse control, and are central to academic performance, and a healthy...

    Background: Executive functions are higher cognitive control functions, consisting of working memory, cognitive flexibility, and impulse control, and are central to academic performance, and a healthy and successful life. While it has been shown that executive functions are trainable, how such improvements translate into everyday behaviors is not yet fully understood. Objective: The current study, was designed to develop an intervention capable of enhancing executive functions among children aged 9 to 11, by means of a multi-component approach that includes focused exercise, cognitive games, socio-emotional development, and eHealth. Methods: The design of this intervention, and the development of the program materials, is guided by the Intervention Mapping framework. The effectiveness of the intervention will be tested in a Cluster Randomized Trial comprising 13 schools, 34 groups, and 800 children, using a battery of six computer tasks. Each of the three core executive functions is measured by two tasks. Moreover, we will administer questionnaires that measure emotion-regulation, cognitive errors, physical activity, dietary habits, and the psycho-social determinants of diet and physical activity. BMI will also be measured. Multilevel analyses will account for clustering at the school- and group level, and randomization will take place at the school level. Results: The intervention was implemented from November 2015 until May 2016. Participating children were measured right before and after the intervention, in October 2015, and June 2016. First publications are to be expected in 2017. Conclusions: Encouraging the development of executive functions could yield great benefits in terms of academic performance, health, and decreased risks during adolescence. We hope that an effective and practical school-based training program will be adopted by a large number of schools in the future, boosting the healthy development of many more children. Clinical Trial: Nederlands Trialregister (Dutch Trial Register) NTR 5804 www.trialregister.nl

  • Developing a geolocated directory of PrEP-providing clinics: the PrEP Locator Protocol

    Date Submitted: Apr 22, 2017

    Open Peer Review Period: Apr 25, 2017 - May 9, 2017

    Background: Introduction: HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission, yet patients interested in learning more about PrEP or in getting a PrEP prescription...

    Background: Introduction: HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission, yet patients interested in learning more about PrEP or in getting a PrEP prescription may not be able to find local medical providers willing to prescribe PrEP. Objective: We sought to create a national database of PrEP providing clinics, to allow for patients to have access to a unified, vetted source of PrEP providers in an easily accessible database. Methods: To develop the protocol and operating procedures for PrEP Locator, we conducted a series of seven key informant interviews with experts who had organized PrEP or other HIV service directories. We convened an External Advisory Committee and a Collaborators Board to gain expert and community-situated perspectives. Results: At its public release in September, 2016, the database included 1,272 PrEP providing clinics, including clinics in all 50 states and in Puerto Rico. Web searches, referrals, and outreach to state health departments identified 58 unique lists of PrEP-providing clinics, with 33 from state health departments, 6 from government localities, two from professional medical organizations, and 19 from non-governmental organizations. Out of 2,420 clinics identified from the lists and web searches, 798 were removed as duplicate entries and 350 were determined to be ineligible for listing. The most common reasons for ineligibility were not having the appropriate medical licensure to prescribe PrEP (67/350) or self-report as not prescribing PrEP (192/350). Key informant interviews shaped important protocol decisions, such as listing clinics instead of individual clinicians as the primary data element, streamlining data collection to facilitate scalability, and creation of standardized eligibility determination procedures. Data required for inclusion are clinic contact information, address, and clinician name. Data collected when available include whether a clinic offers financial access navigation or provides PrEP services to uninsured patients. A web interface was developed for public access to the data, with geolocated data display, search filter functionality, and a publicly available web tool that can be embedded in websites. A publicly available webform allows for suggestions of new clinics; webform-entered clinic eligibility is determined prior to the data being publicly viewable. In the six months following release, preplocator.org and hosting websites had received over 35,000 unique views, over 300 clinic additions, and five websites initiating hosting of the widget. Conclusions: Directories exist for many preventive and treatment services. As new medical applications become available, there will be corresponding needs to develop new directories of service provision. Geolocated directories can assist patients in accessing care, and have the potential to increase demand for and access to newer and more efficacious medical interventions. Early choices in the development of service directories have long-lasting impact, because once data collection begins, it can be challenging to reverse course. The PrEP Locator protocol may inform early decisions in development of future service directories. Additionally, the case study of developing the PrEP Locator demonstrates the importance of formative work in identifying service-specific factors that can guide decisions on directory development.

  • Reducing Medication Errors and Time to Drugs Delivery during Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial

    Date Submitted: Apr 21, 2017

    Open Peer Review Period: Apr 22, 2017 - May 6, 2017

    Background: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is both complex and time-consuming. The need for individual specific weight-based...

    Background: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is both complex and time-consuming. The need for individual specific weight-based drug doses calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication IN Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were significantly reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. Objective: The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces similarly medication dosage errors (primary outcome), as well as drug preparation time (TDP) and time to delivery (TDD; secondary outcome) during pediatric CPR when compared with conventional preparation methods. Methods: This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD includes TDP. Stress level during the resuscitation scenario will be assessed for each participant by the aim of a questionnaire and recorded by heart rate monitors of a fitness watch. Results: Enrollment and data analysis started on March 2017. We anticipate that the intervention will be completed in late 2017, and study results will be submitted in early 2018 for publication expected in mid 2018. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH). Conclusions: This paper describes the protocol used for a clinical trial assessing the impact of a mobile device app to reduce the rate of medication errors, time to drug preparation, and time to delivery during pediatric resuscitation. Results generated from this study will be of paramount importance, as research in this area is scarce and they might by sufficient to change and improve the pediatric emergency care practice. Clinical Trial: Clinicaltrials.gov NCT03021122

  • Project Stronger Together: A protocol to test a dyadic intervention to improve engagement in HIV care among sero-discordant male couples in US cities

    Date Submitted: Apr 18, 2017

    Open Peer Review Period: Apr 21, 2017 - May 5, 2017

    Background: An estimated one- to two-thirds of new HIV infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this, there remains a lack of preve...

    Background: An estimated one- to two-thirds of new HIV infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk and to support each other towards active engagement in HIV prevention and care are urgently needed. Objective: The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States. Methods: The research activities involve a prospective randomized control trial (RCT) of approximately 165 venue and clinic-recruited sero-discordant male couples (330 individuals: 165 HIV sero-negative and 165 HIV sero-positive). The study takes place in three cities: Atlanta, GA (study site Emory University), Boston, MA (study site The Fenway Institute) and Chicago, IL (study site Ann & Robert H. Lurie Children’s Hospital of Chicago). Cohort recruitment began in 2015. Couples are followed prospectively for 24 months, with study assessments at baseline, 6, 12, 18 and 24 months. Results: Stronger Together was launched in August 2014. To date, 135 couples (80% of the target enrollment) have been enrolled and randomized. The average retention rate across the three sites is 95%. Relationship dissolution has been relatively low, with only 13 couples breaking up during the RCT. Of the 13 couples who have broken up, 10 of the 13 HIV-positive partners have been retained in the cohort. None of these HIV-positive partners have enrolled new partners into the RCT. Conclusions: The intervention offers a unique opportunity for sero-discordant couples to support each other towards common HIV management goals by facilitating their development of tailored prevention plans via couples-based HIV testing and counseling as well as problem-solving skills in Partner STEPS. Clinical Trial: ClinicalTrials.gov (NCT01772992). Emory University (IRB #00065111), The Fenway Institute (IRB # FWA00000145), and Lurie Children’s (IRB #2014-15896) Institutional Review Board approved.

  • Feasibility of a Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence: A Study Protocol

    Date Submitted: Apr 13, 2017

    Open Peer Review Period: Apr 17, 2017 - May 1, 2017

    While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular disease (CVD), participation is generally poor. For this reason, the current research, a prospective, rand...

    While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular disease (CVD), participation is generally poor. For this reason, the current research, a prospective, randomized controlled pilot study, will evaluate the impact of a social media intervention on motivation for exercise and adherence to CR sessions. Participants will be recruited during their intake visit to CR. They will then be randomly assigned to a private Facebook group or an enhanced education comparison group. This study is grounded in Self-Determination Theory (SDT) and utilizes the Behavioral Regulation in Exercise Questionnaire (BREQ-2), which is based on the SDT. The intervention will include access to a private Facebook group in which participants will receive weekly educational posts, weekly provider support and have the opportunity to communicate with other cardiac rehabilitation patients. Postings and peer support are designed to enhance autonomous motivation through support of autonomy, competence and relatedness, various levels of behavioral regulation described by SDT. Patients in the comparison group will be given the same educational and provider materials, but these will be supplied in handout form, or email if the patient is absent from cardiac rehabilitation. Participants will be asked to fill out a pre-post motivational questionnaire and the total number of sessions attended at the end of 3 months will be tallied and analyzed using t-tests. Groups will be compared on overall motivation, measured by the Relative Autonomy Index from the BREQ-2, using analysis of covariance models. Engagement in the Facebook group will be measured by counting number of “likes” and self-report of weekly use (“hits”). The researchers plan to enroll 30 participants in each group for a total of 60. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using a social media intervention to affect adherence and motivation in CR patients, potentially improving outcomes through the use of a unique intervention.

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