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 2016: 5.175)

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:

  • Sample SMS message sent to the women from the intervention group. Source: Image created by the authors; Copyright: Myat Pan Hmone; URL: http://www.researchprotocols.org/2017/6/e126/; License: Creative Commons Attribution (CC-BY).

    Mobile Phone Short Messages to Improve Exclusive Breastfeeding and Reduce Adverse Infant Feeding Practices: Protocol for a Randomized Controlled Trial in...

    Abstract:

    Background: Myanmar has a high burden of mortality for children aged younger than 5 years in which undernutrition plays a major role. Despite current efforts, the exclusive breastfeeding rate for children under 6 months is only 24%. To date there have been no interventions using mobile phones to improve breastfeeding and other feeding practices in Myanmar. Objective: This study aims to implement a breastfeeding promotion intervention using mobile phone text messages in Yangon, Myanmar, and evaluate its impact on breastfeeding practices. Methods: M528 is a 2-group parallel-arm randomized controlled trial with 9 months follow-up from recruitment until 6 months post-delivery. A total of 353 pregnant women between 28 and 34 weeks’ gestation who had access to a mobile phone and were able to read and write have been recruited from the Central Women’s Hospital, Yangon, and allocated randomly to an intervention or control group in a 1:1 ratio. The intervention group received breastfeeding promotional SMS messages 3 times a week while the control group received maternal and child health care messages (excluding breastfeeding-related messages) once a week. The SMS messages were tailored for the women’s stage of gestation or the child’s age. A formative qualitative study was conducted prior to the trial to inform the study design and text message content. We hypothesize that the exclusive breastfeeding rate in the intervention group will be double that in the control group. The primary outcome is exclusive breastfeeding from birth to 6 months and secondary outcomes are median durations of exclusive breastfeeding and other infant feeding practices. Both primary and secondary outcomes were assessed by monthly phone calls at 1 to 6 months postdelivery in both groups. Participants’ delivery status was tracked through text messages, phone calls, and hospital records, and delivery characteristics were assessed 1 month after delivery. Child morbidity and breastfeeding self-efficacy scores were assessed at 1, 3, and 5 months postdelivery. Social desirability was measured at 5 months, and text messages expressing delivery success and user experience were assessed at the end of the study. Results: The targeted 353 pregnant women were recruited between January and March 2015. Baseline data have been collected; SMS messages have been developed and pretested and sent to the women from both groups. Follow-up data collection via phone calls has been completed. Data analysis is being done and results are expected soon. This is the first RCT study examining the effects of mobile text messaging for promoting exclusive breastfeeding. Conclusions: This trial is timely in Myanmar following the telecommunications market opening in 2014. Our results will help determine whether text messaging is an effective and feasible method for promoting appropriate feeding practices and will inform further research to assess how this model could be replicated in the broader community. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12615000063516; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367704 (Archived by WebCite at http://www.webcitation.org/ 6rGif3l81)

  • Screenshot of the Soulage TAVIE Post-Trauma website, which illustrates a nurse providing feedback to a patient on applied self-management behaviors based on her/his pain intensity evaluation. Source: The Authors; Copyright: Soulage TAVIE Post-Trauma; URL: http://tavie.cr.chumontreal.qc.ca/TAVIETrauma/; License: Fair use/fair dealings.

    A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma...

    Abstract:

    Background: Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). Objective: This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities. Methods: A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work. Results: Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018. Conclusions: Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs)

  • Developer holding a phone displaying the app. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/e122/; License: Creative Commons Attribution (CC-BY).

    Reducing Parental Uncertainty Around Childhood Cancer: Implementation Decisions and Design Trade-Offs in Developing an Electronic Health Record-Linked Mobile...

    Abstract:

    Background: Parents of children newly diagnosed with cancer are confronted with multiple stressors that place them at risk for significant psychological distress. One strategy that has been shown to help reduce uncertainty is the provision of basic information; however, families of newly diagnosed cancer patients are often bombarded with educational material. Technology has the potential to help families manage their informational needs and move towards normalization. Objective: The aim of this study was to create a mobile app that pulls together data from both the electronic health record (EHR) and vetted external information resources to provide tailored information to parents of newly diagnosed children as one method to reduce the uncertainty around their child’s illness. This app was developed to be used by families in a National Institutes of Health (NIH)-funded randomized controlled trial (RCT) aimed at decreasing uncertainty and the subsequent psychological distress. Methods: A 2-phase qualitative study was conducted to elicit the features and content of the mobile app based on the needs and experience of parents of children newly diagnosed with cancer and their providers. Example functions include the ability to view laboratory results, look up appointments, and to access educational material. Educational material was obtained from databases maintained by the National Cancer Institute (NCI) as well as from groups like the Children’s Oncology Group (COG) and care teams within Cincinnati Children’s Hospital Medical Center (CCHMC). The use of EHR-based Web services was explored to allow data like laboratory results to be retrieved in real-time. Results: The ethnographic design process resulted in a framework that divided the content of the mobile app into the following 4 sections: (1) information about the patient’s current treatment and other data from the EHR; (2) educational background material; (3) a calendar to view upcoming appointments at their medical center; and (4) a section where participants in the RCT document the study data. Integration with the NCI databases was straightforward; however, accessing the EHR Web services posed a challenge, though the roadblocks were not technical in nature. The lack of a formal, end-to-end institutional process for requesting Web service access and a mechanism to shepherd the request through all stages of implementation proved to be the biggest barrier. Conclusions: We successfully deployed a mobile app with a custom user interface that can integrate with the EHR to retrieve laboratory results and appointment information using vendor-provided Web services. Developers should expect to face hurdles when integrating with the EHR, but many of them can be addressed with frequent communication and thorough documentation. Executive sponsorship is also a key factor for success. Trial Registration: ClinicalTrials.gov NCT02505165; https://clinicaltrials.gov/ct2/show/NCT02505165 (Archived by WebCite at http://www.Webcitation.org/6r9ZSUgoT)

  • Participant connecting people in her personal social network using OpenEddi data collection software on a smartphone. Source: The authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/6/e124/; License: Creative Commons Attribution (CC-BY).

    An Interactive, Mobile-Based Tool for Personal Social Network Data Collection and Visualization Among a Geographically Isolated and Socioeconomically...

    Abstract:

    Background: Personal social networks have a profound impact on our health, yet collecting personal network data for use in health communication, behavior change, or translation and dissemination interventions has proved challenging. Recent advances in social network data collection software have reduced the burden of network studies on researchers and respondents alike, yet little testing has occurred to discover whether these methods are: (1) acceptable to a variety of target populations, including those who may have limited experience with technology or limited literacy; and (2) practical in the field, specifically in areas that are geographically and technologically disconnected, such as rural Appalachian Kentucky. Objective: We explored the early-stage feasibility (Acceptability, Demand, Implementation, and Practicality) of using innovative, interactive, tablet-based network data collection and visualization software (OpenEddi) in field collection of personal network data in Appalachian Kentucky. Methods: A total of 168 rural Appalachian women who had previously participated in a study on the use of a self-collected vaginal swab (SCVS) for human papillomavirus testing were recruited by community-based nurse interviewers between September 2013 and August 2014. Participants completed egocentric network surveys via OpenEddi, which captured social and communication network influences on participation in, and recruitment to, the SCVS study. After study completion, we conducted a qualitative group interview with four nurse interviewers and two participants in the network study. Using this qualitative data, and quantitative data from the network study, we applied guidelines from Bowen et al to assess feasibility in four areas of early-stage development of OpenEddi: Acceptability, Demand, Implementation, and Practicality. Basic descriptive network statistics (size, edges, density) were analyzed using RStudio. Results: OpenEddi was perceived as fun, novel, and superior to other data collection methods or tools. Respondents enjoyed the social network survey component, and visualizing social networks produced thoughtful responses from participants about leveraging or changing network content and structure for specific health-promoting purposes. Areas for improved literacy and functionality of the tool were identified. However, technical issues led to substantial (50%) data loss, limiting the success of its implementation from a researcher’s perspective, and hindering practicality in the field. Conclusions: OpenEddi is a promising data collection tool for use in geographically isolated and socioeconomically disadvantaged populations. Future development will mitigate technical problems, improve usability and literacy, and test new methods of data collection. These changes will support goals for use of this tool in the delivery of network-based health communication and social support interventions to socioeconomically disadvantaged populations.

  • Source: Unsplash; Copyright: Thomas Lefebvre; URL: https://unsplash.com/collections/173229/work-online?photo=gp8BLyaTaA0; License: Licensed by JMIR.

    Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With...

    Abstract:

    Background: Caregivers of cancer patients experience significant burden and distress including depression and anxiety. We previously demonstrated the efficacy of an eight session, in-person, one-on-one stress management intervention to reduce distress in caregivers of patients receiving allogeneic hematopoietic stem cell transplants (allo-HSCT). Objective: The objective of this study was to adapt and enhance the in-person caregiver stress management intervention to a mobilized website (eg, tablet, smartphone, or computer-based) for self-delivery in order to enhance dissemination to caregiver populations most in need. Methods: We used an established approach for development of a mhealth intervention, completing the first two research and evaluation steps: Step One: Formative Research (eg, expert and stakeholder review from patients, caregivers, and palliative care experts) and Step Two: Pretesting (eg, Focus Groups and Individual Interviews with caregivers of patients with autologous HSCT (auto-HSCT). Step one included feedback elicited for a mock-up version of Pep-Pal session one from caregiver, patients and clinician stakeholders from a multidisciplinary palliative care team (N=9 caregivers and patient stakeholders and N=20 palliative care experts). Step two included two focus groups (N=6 caregivers) and individual interviews (N=9 caregivers) regarding Pep-Pal’s look and feel, content, acceptability, and potential usability/feasibility. Focus groups and individual interviews were audio-recorded. In addition, individual interviews were transcribed, and applied thematic analysis was conducted in order to gain an in-depth understanding to inform the development and refinement of the mobilized caregiver stress management intervention, Pep-Pal (PsychoEducation and skills for Patient caregivers). Results: Overall, results were favorable. Pep-Pal was deemed acceptable for caregivers of patients receiving an auto-HSCT. The refined Pep-Pal program consisted of 9 sessions (Introduction to Stress, Stress and the Mind Body Connection, How Thoughts Can Lead to Stress, Coping with Stress, Strategies for Maintaining Energy and Stamina, Coping with Uncertainty, Managing Changing Relationships and Communicating Needs, Getting the Support You Need, and Improving Intimacy) delivered via video instruction through a mobilized website. Conclusions: Feedback from stakeholder groups, focus groups, and individual interviews provided valuable feedback in key areas that was integrated into the development of Pep-Pal with the goal of enhancing dissemination, engagement, acceptability, and usability.

  • Trial logo. Source: The Authors; Copyright: Raimondo Ascione; URL: http://www.researchprotocols.org/2017/6/e119/; License: Creative Commons Attribution (CC-BY).

    The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled...

    Abstract:

    Background: Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. Objective: The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to “fit for discharge”, incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. Methods: In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann’s solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were “fit for discharge”, which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Results: Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. Conclusions: VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK)

  • Participant engaging in active video game play on the adapted balance board. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/6/e116/; License: Creative Commons Attribution (CC-BY).

    Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol

    Abstract:

    Background: Individuals with disabilities are typically more sedentary and less fit compared to their peers without disabilities. Furthermore, engaging in physical activity can be extremely challenging due to physical impairments associated with disability and fewer opportunities to participate. One option for increasing physical activity is playing active video games (AVG), a category of video games that requires much more body movement for successful play than conventional push-button or joystick actions. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in physical activity. Objective: Our aim was to compare the effect of off-the-shelf and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with physical disabilities, specifically those with mobility impairments (ie, unable to stand, balance issues, poor motor control, unable to use lower extremity for gameplay). The gaming controllers to be evaluated include off-the-shelf and adapted versions of the Wii Fit balance board and gaming mat. Methods: Participants (10-60 years old) came to the laboratory a total of three times. During the first visit, participants completed a functional assessment and became familiar with the equipment and games to be played. For the functional assessment, participants performed 18 functional movement tasks from the International Classification of Functioning, Disability, and Health. They also answered a series of questions from the Patient Reported Outcomes Measurement Information System and Quality of Life in Neurological Conditions measurement tools, to provide a personal perspective regarding their own functional ability. For Visit 2, metabolic data were collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played. Results: Enrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017. Conclusions: We hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions. Trial Registration: ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7)

  • Source: Unsplash; Copyright: freestocks.org; URL: https://unsplash.com/search/phone?photo=m7zKB91brGo; License: Licensed by JMIR.

    Phone-Based Interventions in Adolescent Psychiatry: A Perspective and Proof of Concept Pilot Study With a Focus on Depression and Autism

    Abstract:

    Background: Telemedicine has emerged as an innovative platform to diagnose and treat psychiatric disorders in a cost-effective fashion. Previous studies have laid the functional framework for monitoring and treating child psychiatric disorders electronically using videoconferencing, mobile phones (smartphones), and Web-based apps. However, phone call and text message (short message service, SMS) interventions in adolescent psychiatry are less studied than other electronic platforms. Further investigations on the development of these interventions are needed. Objective: The aim of this paper was to explore the utility of text message interventions in adolescent psychiatry and describe a user feedback-driven iterative design process for text message systems. Methods: We developed automated text message interventions using a platform for both depression (EpxDepression) and autism spectrum disorder (ASD; EpxAutism) and conducted 2 pilot studies for each intervention (N=3 and N=6, respectively). The interventions were prescribed by and accessible to the patients’ healthcare providers. EpxDepression and EpxAutism utilized an automated system to triage patients into 1 of 3 risk categories based on their text responses and alerted providers directly via phone and an online interface when patients met provider-specified risk criteria. Rapid text-based feedback from participants and interviews with providers allowed for quick iterative cycles to improve interventions. Results: Patients using EpxDepression had high weekly response rates (100% over 2 to 4 months), but exhibited message fatigue with daily prompts with mean (SD) overall response rates of 66.3% (21.6%) and 64.7% (8.2%) for mood and sleep questionnaires, respectively. In contrast, parents using EpxAutism displayed both high weekly and overall response rates (100% and 85%, respectively, over 1 to 4 months) that did not decay significantly with time. Monthly participant feedback surveys for EpxDepression (7 surveys) and EpxAutism (18 surveys) preliminarily indicated that for both interventions, daily messages constituted the “perfect amount” of contact and that EpxAutism, but not EpxDepression, improved patient communication with providers. Notably, EpxDepression detected thoughts of self-harm in patients before their case managers or caregivers were aware of such ideation. Conclusions: Text-message interventions in adolescent psychiatry can provide a cost-effective and engaging method to track symptoms, behavior, and ideation over time. Following the collection of pilot data and feedback from providers and patients, larger studies are already underway to validate the clinical utility of EpxDepression and EpxAutism. Trial Registration: Clinicaltrials.gov NCT03002311; https://clinicaltrials.gov/ct2/show/NCT03002311 (Archived by WebCite at http://www.webcitation.org/6qQtlCIS0)

  • Database screenshot. Source: The Authors and Placeit.net (montage); Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/e115/; License: Creative Commons Attribution (CC-BY).

    A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey

    Abstract:

    Background: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. Objective: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. Methods: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). Results: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. Conclusions: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. Trial Registration: Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v)

  • Duke Heart Center Patient Survey. Source: The Authors; Copyright: Hanzhang Xu; URL: http://www.researchprotocols.org/2017/6/e118/; License: Creative Commons Attribution (CC-BY).

    Identifying Nonclinical Factors Associated With 30-Day Readmission in Patients with Cardiovascular Disease: Protocol for an Observational Study

    Abstract:

    Background: Cardiovascular disease (CVD) is the leading cause of hospitalization in older adults and high readmission rates have attracted considerable attention as actionable targets to promote efficiency in care and to reduce costs. Despite a plethora of research over the past decade, current strategies to predict readmissions have been largely ineffective and efforts to identify novel clinical predictors have been largely unsuccessful. Objective: The objective of this study is to examine a wide array of socioeconomic, psychosocial, behavioral, and clinical factors to predict risks of 30-day hospital readmission in cardiovascular patients. Methods: The study includes patients (aged 18 years and older) admitted for the treatment of cardiovascular-related illnesses at the Duke Heart Center, which is among the nation’s largest and top-ranked cardiovascular care hospitals. The study uses a novel standardized survey to ascertain data on a comprehensive array of patient characteristics that will be linked to their electronic medical records. A series of univariate and multivariate models will be used to estimate the associations between the patient-level factors and 30-day readmissions. The performance of the risk models will be examined based on 2 components of accuracy—model calibration and discrimination—to determine how closely the predicted outcome agrees with the observed (actual) outcome and how well the model distinguishes patients who were readmitted and those who were not. The purpose of this paper is to present the protocol for the implementation of this study. Results: The study was launched in February 2014 and is actively recruiting patients from the Heart Center. Approximately 550 patients have been enrolled to date and the study is expected to continue recruitment until February 2018. Preliminary results show that participants in the study were aged 63.6 years on average (SD 14.0), predominately male (61.2%), and primarily non-Hispanic white (64.6%) or non-Hispanic black (31.7%). The demographic characteristics of study participants were not significantly different from all patients admitted to the Heart Center during this period with an average age of 65.0 years (SD 15.3) and predominately male (58.6%), non-Hispanic white (62.9%) or non-Hispanic black (31.8%) The integration of the interview data with clinical data from the patient electronic medical records is currently underway. The study has received funding and ethical approval. Conclusions: Many US hospitals continue to struggle with high readmission rates in patients with cardiovascular disease. The primary objective of this study is to collect and integrate a comprehensive array of patient attributes to develop a powerful yet parsimonious model to stratify risks of rehospitalization in cardiovascular patients. The results of this research also have the potential to identify actionable targets for tailored interventions to improve patient outcomes.

  • Preterm infant receiving PULSED NTrainer stimulation during gavage feeding in the neonatal intensive care unit, with a nasogastric tube. Source: The Authors; Copyright: Innara Health, Inc.; URL: http://www.innarahealth.com/; License: Creative Commons Attribution (CC-BY).

    Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants: Randomized Controlled Trial

    Abstract:

    Background: Despite numerous medical advances in the care of at-risk preterm neonates, oral feeding still represents one of the first and most advanced neurological challenges facing this delicate population. Objective, quantitative, and noninvasive assessment tools, as well as neurotherapeutic strategies, are greatly needed in order to improve feeding and developmental outcomes. Pulsed pneumatic orocutaneous stimulation has been shown to improve nonnutritive sucking (NNS) skills in preterm infants who exhibit delayed or disordered nipple feeding behaviors. Separately, the study of the salivary transcriptome in neonates has helped identify biomarkers directly linked to successful neonatal oral feeding behavior. The combination of noninvasive treatment strategies and transcriptomic analysis represents an integrative approach to oral feeding in which rapid technological advances and personalized transcriptomics can safely and noninvasively be brought to the bedside to inform medical care decisions and improve care and outcomes. Objective: The study aimed to conduct a multicenter randomized control trial (RCT) to combine molecular and behavioral methods in an experimental conceptualization approach to map the effects of PULSED somatosensory stimulation on salivary gene expression in the context of the acquisition of oral feeding habits in high-risk human neonates. The aims of this study represent the first attempt to combine noninvasive treatment strategies and transcriptomic assessments of high-risk extremely preterm infants (EPI) to (1) improve oral feeding behavior and skills, (2) further our understanding of the gene ontology of biologically diverse pathways related to oral feeding, (3) use gene expression data to personalize neonatal care and individualize treatment strategies and timing interventions, and (4) improve long-term developmental outcomes. Methods: A total of 180 extremely preterm infants from three neonatal intensive care units (NICUs) will be randomized to receive either PULSED or SHAM (non-pulsing) orocutaneous intervention simultaneous with tube feedings 3 times per day for 4 weeks, beginning at 30 weeks postconceptional age. Infants will also be assessed 3 times per week for NNS performance, and multiple saliva samples will be obtained each week for transcriptomic analysis, until infants have achieved full oral feeding status. At 18 months corrected age (CA), infants will undergo neurodevelopmental follow-up testing, the results of which will be correlated with feeding outcomes in the neo-and post-natal period and with gene expression data and intervention status. Results: The ongoing National Institutes of Health funded randomized controlled trial R01HD086088 is actively recruiting participants. The expected completion date of the study is 2021. Conclusions: Differential salivary gene expression profiles in response to orosensory entrainment intervention are expected to lead to the development of individualized interventions for the diagnosis and management of oral feeding in preterm infants. Trial Registration: ClinicalTrials.gov NCT02696343; https://clinicaltrials.gov/ct2/show/NCT02696343 (Archived by WebCite at http://www.webcitation.org/6r5NbJ9Ym)

  • mISkin homescreen (montage). Source: The Authors / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/e112/; License: Creative Commons Attribution (CC-BY).

    Systematic and Iterative Development of a Smartphone App to Promote Sun-Protection Among Holidaymakers: Design of a Prototype and Results of Usability and...

    Abstract:

    Background: Sunburn and intermittent exposure to ultraviolet rays are risk factors for melanoma. Sunburn is a common experience during holidays, making tourism settings of particular interest for skin cancer prevention. Holidaymakers are a volatile populations found at different locations, which may make them difficult to reach. Given the widespread use of smartphones, evidence suggests that this might be a novel, convenient, scalable, and feasible way of reaching the target population. Objective: The main objective of this study was to describe and appraise the process of systematically developing a smartphone intervention (mISkin app) to promote sun-protection during holidays. Methods: The iterative development process of the mISkin app was conducted over four sequential stages: (1) identify evidence on the most effective behavior change techniques (BCTs) used (active ingredients) as well as theoretical predictors and theories, (2) evidence-based intervention design, (3) co-design with users of the mISkin app prototype, and (4) refinement of the app. Each stage provided key findings that were subsequently used to inform the design of the mISkin app. Results: The sequential approach to development integrates different strands of evidence to inform the design of an evidence-based intervention. A systematic review on previously tested interventions to promote sun-protection provided cues and constraints for the design of this intervention. The development and design of the mISkin app also incorporated other sources of information, such as other literature reviews and experts’ consultations. The developed prototype of the mISkin app was evaluated by engaging potential holidaymakers in the refinement and further development of the mISkin app through usability (ease-of-use) and acceptability testing of the intervention prototype. All 17 participants were satisfied with the mISkin prototype and expressed willingness to use it. Feedback on the app was integrated in the optimization process of the mISkin app. Conclusions: The mISkin app was designed to promote sun-protection among holidaymakers and was based on current evidence, experts’ knowledge and experience, and user involvement. Based on user feedback, the app has been refined and a fully functional version is ready for formal testing in a feasibility pilot study.

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  • Design of a Research- and Practice-Based Nutrition Education and Cooking Workshop Curriculum in Pediatric Oncology

    Date Submitted: Jun 26, 2017

    Open Peer Review Period: Jun 27, 2017 - Jul 11, 2017

    Background: Despite progresses in childhood cancer treatment, diagnosis and management, two-thirds of childhood cancer survivors will be affected by late complications including cardiovascular and met...

    Background: Despite progresses in childhood cancer treatment, diagnosis and management, two-thirds of childhood cancer survivors will be affected by late complications including cardiovascular and metabolic diseases. Side effects of cancer treatments can negatively impact children’s nutritional intake and eating behaviors. Adequate nutrition is essential to ensure optimal development and can improve tolerance to treatments. Furthermore, healthy eating can contribute to lower the risk of cardiometabolic diseases. Involving the families of childhood cancer patients in educational workshops could be a promising avenue to promote healthy eating during and after cancer treatment. Objective: To develop and validate a family-based nutrition education and cooking workshop curriculum in a pediatric oncology setting that addresses the nutritional issues encountered during treatments while promoting the adoption of healthy eating habits for the prevention of cardiometabolic late effects. Methods: The workshops were developed and validated following an 8-steps iterative process including a review of the literature and consultations with a steering committee. An evaluation tool was also developed. Results: The themes of the 6 research- and practice-based lessons are: meal fortification during cancer treatments; changes in taste during cancer therapy and their impact on children; adapting diet to eating-related side effects of treatments; Mediterranean diet and health; planning quick and economic meal; nutritional support during cancer treatment. The validation process included consultations with the institution clinical nutrition professionals. Self-administered post questionnaires were developed according to the content of each workshop to measure participants’ perception of knowledge acquisition, behavioral intention and satisfaction. Conclusions: This research- and practice-based nutrition education and cooking demonstration curriculum could consist in a valuable complement to a multidisciplinary lifestyle intervention for prevention of late cardiometabolic complications in childhood cancer.

  • Randomized controlled trial of an 8-week hypnosis-based group intervention for post-treatment cancer patients.

    Date Submitted: Jun 26, 2017

    Open Peer Review Period: Jun 27, 2017 - Jul 11, 2017

    Background: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF) and emotional distress) and on patients’ partners and their relationship, such as fa...

    Background: Cancer has a lot of consequences on patients’ quality of life (such as cancer-related fatigue (CRF) and emotional distress) and on patients’ partners and their relationship, such as fatigue, distress, and communication difficulties. However, these consequences are still undertreated, and interventions such as hypnosis often focus on breast cancer patients only. Objective: Our longitudinal randomized controlled trial aims to assess the efficacy of an 8-week hypnosis-based intervention to improve cancer patients' CRF and emotional distress and to indirectly improve their partners' distress. Methods: A power analysis required a total sample of 88 patients. Results of the experimental group receiving the intervention will be compared to those of the control group. Data will be collected by questionnaires, relaxation tasks, an attentional bias task, and everyday life assessments measured at four different times: 1.) before inclusion in the study (baseline); 2.) after the intervention; and 3.) at 4- and 12-month follow-up. Partners’ symptoms will also be evaluated with questionnaires at the same measurement times. Conclusion: There is a growing interest in alternative approaches (such as hypnosis) in addition to standard therapies in oncology settings. The results of this study should be useful for improving knowledge about long-term efficacy of hypnosis-based group interventions for CRF and distress among all types of cancer patients and their partners, and to better understand the mechanisms of emotional regulation in cancer patients through the attentional bias task.

  • Web-based intervention to teach developmentally-supportive care to parents of preterm infants: feasibility study

    Date Submitted: Jun 23, 2017

    Open Peer Review Period: Jun 25, 2017 - Jul 9, 2017

    Background: Preterm birth affects 8-11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positiv...

    Background: Preterm birth affects 8-11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positive impact on early motor and cognitive development and on parental well-being. However, these programs are often difficult to implement in a real-life setting due to lack of resources. Hence, our multidisciplinary team developed Mieux Agir au Quotidien (MAQ) to teach developmentally-supportive care to parents of preterm infants with the goal of improving child development and parental outcomes. Our intervention included three in-person workshops that occurred prior to hospital discharge and a web-based platform with written and videotaped materials that addressed five main themes: (1) infant behavioural cues; (2) flexion positioning; (3) oral feeding support; (4) parent-infant interactions; (5) anticipation of developmental milestones. Objective: This study aimed to test the acceptability of the intervention by parents of preterm infants and to assess clinical benefits on child neurodevelopment and parental outcomes during the first year of life. Methods: One hundred seven infants born <30 weeks and admitted to Ste-Justine Hospital neonatal intensive care unit and their parents were enrolled in a nonrandomized controlled before-and-after interventional study (intervention n=55, comparison n=52). Acceptability of the program was assessed with a user satisfaction questionnaire. At 4 months’ corrected age, all parents completed questionnaires on infant temperament, parenting stress, sense of competence and parenting satisfaction. At 12 months’ corrected age, neurodevelopmental testing was performed on infants using the Alberta Infant Motor Scale and the Bayley scales 3rd edition. Comparisons between the two groups were done using independent t-test, Wilcoxon rank-sum test, and Fisher’s exact test. Results: Majority of parents (96%) were satisfied with the intervention program and all would recommend MAQ to others. MAQ responded to their need for evidence-based information that proved useful to support their child development. No difference in parental or child neurodevelopmental outcomes was detected in this pilot study for most outcomes except for higher median scores for parental coercive behaviours in the intervention group although proportions scoring in the coercive range did not differ. Conclusions: Acceptability of the program was high among parents thus supporting the relevance of such intervention. A larger study using a randomized controlled trial design is needed to better document impact on parent and children and to investigate how web-based technologies can efficiently complement individualized intervention to alleviate the burden on health care resources.

  • Online communication strategies designed to improve intention to minimize risk for colorectal cancer: a randomized controlled trial to test an FAQ prototype for information targeted by age and gender

    Date Submitted: Jun 21, 2017

    Open Peer Review Period: Jun 22, 2017 - Jul 6, 2017

    Background: Increasingly, people seek information online for managing their health, including colorectal cancer (CRC) risk but retrieve much personally irrelevant material, impacting utility. Targetin...

    Background: Increasingly, people seek information online for managing their health, including colorectal cancer (CRC) risk but retrieve much personally irrelevant material, impacting utility. Targeting people with information pertinent to their cohort via a Frequently Asked Questions (FAQ) format might improve commitment to action. Objective: We identified and prioritized CRC information for men and women aged 35−74 years (Study 1), to build a prototype website containing FAQs ordered by age and gender. In Study 2 we conducted a randomized controlled trial (RCT) to test whether information accessed through targeted FAQs was more influential on intention to act on CRC risk than the same information accessed via a generic topic list. Secondary aims compared preference for information via FAQs or LIST, usability, relevance and likelihood of recommendation of FAQ and LIST websites. Methods: Study 1 determined the CRC information needs of Australians (total N = 600) by sex and age group (35-49, 50-59, 60-74) through an online survey. Free text responses were categorized as FAQs with a focus on the “top 5” issues within each of 6 cohorts. Study 2 compared the impact of presentation as targeted FAQ links to information with links presented as a generic list (LIST), and a CONTROL (no information) condition. Participants (N=240) were block randomized by gender and age group to 1 of 3 conditions. We also tested preference for information presentation as FAQ or LIST by adding a CHOICE condition. Dependent measures were willingness to act on CRC risk and ratings of website usability, relevance and intention to recommend. Results: Study 1 showed considerable consistency in information priorities among all six cohorts with two main concerns; treatment of CRC and risk factors. Some differences included a focus on general risk factors, excluding diet and lifestyle, in the younger cohort, and on the existence of a test for CRC in the older cohorts. Study 2 demonstrated that although respondents preferred information ordered by FAQs over a list, presentation in this format had limited impact on readiness to act on CRC risk compared to the list or a no information control (p=.055). Both FAQ and LIST were evaluated as equally useable. Those aged 35–49 rated the information less relevant to them and others in their age group, and information ordered by FAQs was rated, across all age groups and both sexes, as less relevant to people outside the age group targeted within the FAQs. Conclusions: FAQs are preferred over a list as a strategy for presenting information about CRC. They may improve intention to act on risk although further research is required. Future research should aim to identify better the characteristics of information content and presentation that optimize perceived relevance and fully engage the target audience

  • Implementing a Mental Health Care Program and Home-based Training for Mothers of Children with Autism Spectrum Disorder in an urban population in Bangladesh: Protocol for a feasibility assessment study

    Date Submitted: Jun 22, 2017

    Open Peer Review Period: Jun 22, 2017 - Jul 6, 2017

    Background: Mothers of children with Autism Spectrum Disorder (ASD) have reported a higher level of depression than mothers of children with other neurodevelopmental disorders in both developed and de...

    Background: Mothers of children with Autism Spectrum Disorder (ASD) have reported a higher level of depression than mothers of children with other neurodevelopmental disorders in both developed and developing countries. Mothers are the lifetime caregivers of children with ASD. A high burden of depression negatively impacts on the ability of the mothers to provide care to children at home. Mental health is not addressed in the primary care setting in Bangladesh, and there is a scarcity of qualified providers for supporting mental health care to mothers for supporting child care and improvement of child performances. We aim to pilot the feasibility of integrating mental health services for the mothers of children with ASD and offer a home-based training program for the mothers to improve skills of child care. We have obtained IRB approval from icddr,b. Objective: The primary objective of the study is to assess the feasibility of the proposed intervention at special schools for children with ASD that would provide mental health services and training to mothers suffering from a concurrent major depressive episode (MDE). The secondary aims of the project are to assess the change in the prevalence of MDE among mothers, as well as the any improvement in the degree of individual performance of the children with ASD. Additional project aims include assessment of incremental institutional costs incurred at schools, and out of pocket costs incurred by the families following the introduction of mental health services in combination with the maternal training program in the schools. The broader goal of the research is to assess the barriers to integrating the pilot intervention package with other types of facility-based services as well as prospect for scaling up of the intervention in other institutional settings in urban Bangladesh. Methods: The study will be conducted in two purposively selected schools in Dhaka city in Bangladesh that have been offering services for ASD for more than ten years. A trained female psychologist will be deployed at each of the two schools to offer non pharmacological interventions for mental health following a structured counseling module under the direct supervision of psychiatrists. About 52 to 78 mothers who would be diagnosed as having a depression will be recruited in the intervention (intervention mother) following a written voluntary informed consent. One educational psychologist with advanced training in ASD care (special educator) will provide training to the intervention mothers for enhancing their skills for child care and follow up at home every month. The proposed packaged intervention will be implemented over 4-6 months period, and feasibility of the intervention will be assessed through a pre-post intervention. The primary outcome will include assessment of acceptability, adaptability, demand, practicality, implementation, and integration of the package intervention in the school settings. The secondary outcomes will include assessment of (i) any change in the prevalence of current depression among the mothers of children with ASD following the intervention; (ii) the degree of individual performance of the children regarding behavioral, social and communication skills; and (iii) the costs incurred to institutions and families due to participation in the intervention. Results: Between January and June, 2017, 175 mothers were recruited for baseline information, and assessment of depression and quality of life. In depth interviews were conducted among 10 mothers and 8 various stakeholders. A psychosocial counseling module has been developed, and two psychologists deployed at the schools offered counseling to 41 mothers who have steeped in to the counseling centre on self will. A training module has been developed for mothers under the guidance of an expert working group and three special educators were trained. Data entry and data management are ongoing. Conclusions: The proposed research will provide essential estimates for designing a randomized control trial in order to evaluate the intervention package in a broader setting. Overall, the study will generate compelling evidence for scaling up of the intervention in other institutional settings in Bangladesh and in other countries with a similar situation of ASD and maternal depression. Clinical Trial: NCT03025646; https://clinicaltrials.gov/ct2/show/NCT03025646

  • Study Protocol of SALT: a retrospective multicenter cohort study for determination of the epidemiology of surgical site infections with Staphylococcus Aureus in Europe

    Date Submitted: Jun 16, 2017

    Open Peer Review Period: Jun 19, 2017 - Jul 3, 2017

    Background: Surgical site infections (SSI) are among the most common hospital acquired infections. The incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts i...

    Background: Surgical site infections (SSI) are among the most common hospital acquired infections. The incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts in hospitals and healthcare systems around the world. However, SSI rates vary markedly within surgical categories and are poorly represented by routinely surveilled indicator procedures, e.g. mastectomy or hernia surgery. Therefore, relying on indicator procedures to estimate the burden of SSI is imprecise and introduces bias as hospitals may take special precautions to achieve lower SSI rates. The most common cause of SSI is Staphylococcus aureus, as recently confirmed by a Europe-wide point-prevalence study conducted by the ECDC. Objective: The primary objective is to determine the overall and the procedure specific incidence of S. aureus surgical SSI in Europe. As secondary objectives the overall and the procedure specific outcomes as well as the economic burden of S. aureus SSI in Europe will be evaluated. Explorative objectives are to characterize the composition of the surgical patient population and to estimate the number of patients at risk for S. aureus SSI. Methods: We will conduct a retrospective multinational, multicenter cohort study with a nested case-control part. The study includes all surgical procedures at a participating center in order to prevent selection bias and strengthen the understanding of SSI risk by determining incidence for all common surgical procedures. Data will be assessed in two populations: the cohort, including 150.000 adult patients who underwent any surgical procedure in 2016, and the case-control population; we will match patients establishing S. aureus SSI 1:1 with controls from the same center. Regarding the cohort, we will export data on demographics, surgery and microbiology from electronic files. More detailed data will be captured from the case-control population. The SALT study will include 16 major or academic surgical centers in Europe: five in France, four in Germany, two in Italy, three in Spain and two in the UK. Sites were selected using a feasibility questionnaire. Results: The overall and the procedure specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe will be determined. Furthermore, the composition of the surgical patient population in Europe will be characterized and the number of patients at risk for S. aureus SSI will be estimated. Conclusions: Results of the SALT study will help to better understand the precise risk of certain procedures. They will allow conclusions on the overall and the procedure specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe. Findings of the study may help designing clinical trials for S. aureus vaccines. Clinical Trial: The study is registered at www.clinicaltrials.gov.

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