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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing 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 journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2017: 4.671).

While the original focus was on eHealth studies, JMIR Res Protoc now 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.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

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 provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

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).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • Circles of care. Source: New Health Foundation; Copyright: New Health Foundation; URL: https://drive.google.com/open?id=17gakmGAnLgKGIBE_TUbKnn3Zhj6Rn1Bg; License: Licensed by the authors.

    Development and Management of Networks of Care at the End of Life (the REDCUIDA Intervention): Protocol for a Nonrandomized Controlled Trial

    Abstract:

    Background: End-of-life needs can be only partly met by formalized health and palliative care resources. This creates the opportunity for the social support network of family and community to play a crucial role in this stage of life. Compassionate communities can be the missing piece to a complete care model at the end of life. Objective: The main objective of this study is to evaluate the REDCUIDA (Redes de Cuidados or Network of Care) intervention for the development and management of networks of care around people with advanced disease or at the end of life. Methods: The study is a 2-year nonrandomized controlled trial using 2 parallel groups. For the intervention group, we will combine palliative care treatment with a community promoter intervention, compared with a control group without intervention. Participants will be patients under a community palliative care team’s supervision with and without intervention. The community promotor will deliver the intervention in 7 sessions at 2 levels: the patient and family level will identify unmet needs, and the community level will activate resources to develop social networks to satisfy patient and family needs. A sample size of 320 patients per group per 100,000 inhabitants will offer adequate information and will give the study 80% power to detect a 20% increase in unmet needs, decrease families’ burden, improve families’ satisfaction, and decrease the use of health system resources, the primary end point. Results will be based on patients’ baseline and final analysis (after 7 weeks of the intervention). We will carry out descriptive analyses of variables related to patients’ needs and of people involved in the social network. We will analyze pre- and postintervention data for each group, including measures of central tendency, confidence intervals for the 95% average, contingency tables, and a linear regression. For continuous variables, we will use Student t test to compare independent samples with normal distribution and Mann-Whitney U test for nonnormal distributions. For discrete variables, we will use Mann-Whitney U test. For dichotomous variables we will use Pearson chi-square test. All tests will be carried out with a significance level alpha=.05. Results: Ethical approval for this study was given by the Clinical Research Committee of Andalusian Health Service, Spain (CI 1020-N-17), in June 2018. The community promoter has been identified, received an expert community-based palliative care course, and will start making contacts in the community and the palliative care teams involved in the research project. Conclusions: The results of this study will provide evidence of the benefit of the REDCUIDA protocol on the development and assessment of networks of compassionate communities at the end of life. It will provide information about clinical and emotional improvements, satisfaction, proxy burden, and health care resource consumption regarding patients in palliative care. Registered Report Identifier: RR1-10.2196/10515

  • BaroTest kit. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e180/; License: Creative Commons Attribution (CC-BY).

    Innovative Approach for Enhancing Testing of HIV, Hepatitis B, and Hepatitis C in the General Population: Protocol for an Acceptability and Feasibility Study...

    Abstract:

    Background: Despite substantial screening for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) infections in France, a great number of infected persons remain undiagnosed. In this context, Santé publique France experimented with a new screening approach for HBV, HCV, and HIV infection, based on home self-sampling using dried blood spot (DBS) for blood collection. Objective: The objectives of the BaroTest study were to assess the acceptability and feasibility of this approach and to update the prevalence estimates of HBV, HCV, and HIV infections in the general population. Methods: Participants were enrolled using the 2016 Health Barometer, a national cross-sectional telephone survey based on a large representative sample of the general population aged 15 to 75 years (N=15,000). Upon completion of the questionnaire, any participant in the Health Barometer aged 18 to 75 years, having medical health insurance, and not under guardianship was invited to receive a self-sampling kit delivered by standard postal mail and to return the DBS card to the laboratory. The laboratory was then responsible for reporting the results to the participants. Acceptability of the protocol was based on the percentage of eligible individuals agreeing to receive the self-sampling kit, on the proportion of people returning the DBS card, and on the proportion of participants out of the total eligible population. The feasibility of the approach was based on the number of participants with adequately filled blood spots and the number of participants with blood spots for which at least one virological analysis could be performed. A complex system of reminders was implemented to increase the participation rate. Accordingly, we assumed that 35.00% (4900/14,000) of eligible persons would accept and return their DBS card. As the highest expected prevalence was for HBV infection, estimated at 0.65% in 2004, 5000 persons would make it possible to estimate this prevalence with an accuracy of approximately 0.22%. All indicators can be analyzed according to the characteristics of the participants collected in the Health Barometer questionnaire. BaroTest was approved by the French Ethics Committee (November 11, 2015) and the Commission on Information Technology and Liberties (December 24, 2015). The study has been registered by the French medical authority under number 2015-A01252-47 on November 10, 2015. Results: The results on acceptability and feasibility are expected in the last quarter of 2018 and those on the prevalence estimates in the first semester of 2019. Conclusions: The BaroTest results will help to inform new strategies for HIV, HBV, and HCV screening, and the Health Barometer provides a reliable updated assessment of the burden of HBV, HCV, and HIV infections in the general population in France while reducing the costs typically associated with this type of research. Registered Report Identifier: RR1-10.2196/9797

  • GeMRC logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e179; License: Licensed by JMIR.

    Using Social Media and Web-Based Networking in Collaborative Research: Protocol for the Geriatric Medicine Research Collaborative

    Abstract:

    Background: Traditional pathways to promote research collaboration typically take years to expand beyond individual institutions. Social media and online networking provide an innovative approach to promote research collaboration. Objective: The objective of this paper is to present the formation of the Geriatric Medicine Research Collaborative, United Kingdom — a national trainee-led research collaborative. This collaborative aims to facilitate research projects that will directly benefit older patients, improve research skills of geriatric medicine trainees, and facilitate recommendations for health care policy for older adults. Methods: Our methods of collaboration comprised trainee-led meetings regionally and at national conferences, email communication, direct uploading of project material to our website, social media, and virtual meetings. Structured use of local, regional, and network leads has facilitated this collaboration. Having a clear virtual presence has been the key to the rapid development of the network. Results: The use of social media and online networking encouraged the involvement of multiple regions early in the development of the collaborative and allowed rapid dissemination of project ideas. This facilitated the collection of large datasets and enhanced scientific validity of project outcomes. Furthermore, this has the potential to transform geriatric medicine research, as older patients have been historically excluded from large commercial trials due to multimorbidity, frailty, and cognitive impairment. Conclusions: Perceived limitations to predominantly online or virtual collaboratives, including reduced accountability, and loss of interpersonal relationships are balanced by increased trainee engagement, high frequency of communication, and rapid access to a breadth of expertise. Utilization of virtual communication has the potential to lead to future interspecialty, interprofessional, and international collaboration, and to accelerate research that improves outcomes for older adults.

  • Female participant holding a phone with sample pMOTAR screen (montage). Source: The Authors / iStock by Getty Images; Copyright: The Authors / iStock by Getty Images; URL: http://www.researchprotocols.org/2018/9/e175/; License: Licensed by the authors.

    Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial

    Abstract:

    Background: Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice in preventive vaccine trials, under the HIV Vaccine Trials Network (HVTN), is to capture related side effects in a hardcopy tool. The reconciliation of this tool, 2 weeks after vaccination at the safety visit, is time consuming, laborious, and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool may improve accuracy and completeness of collected data and prove feasible and acceptable over the hardcopy tool. Objective: The objective of our study is to develop and implement a USSD tool for real-time safety data collection that is feasible and acceptable to participants and staff, allowing for a comparison with the hardcopy tool in terms of completeness and accuracy. Methods: This feasibility study is being conducted at a single study site, the Centre for the AIDS Programme of Research in South Africa eThekwini Clinical Research site, in South Africa. The feasibility study is nested within a parent phase 1/2a preventive HIV vaccine trial (HVTN 108) as an open-label, randomized controlled trial, open to all consenting parent trial participants. Participants are randomly assigned in a 1:1 ratio to the hardcopy or USSD tool, with data collection targeted to the third and fourth injection time points in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the safety visit. We will itemize and compare error rates between the hardcopy tool and the USSD printout and associated source documentation. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool. Results: The study has received regulatory approval. We have designed and developed the USSD tool to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both English and isiZulu have been successfully installed on a tablet. Data collection is complete, but analysis is pending. Conclusions: Several HIV preventive vaccine trials are active in Southern Africa, making tools to improve efficiencies and minimize error necessary. Our results will help to determine whether the USSD tool can be used in future vaccine studies and can eventually be rolled out. Trial Registration: ClincalTrials.gov NCT02915016; https://clinicaltrials.gov/ct2/show/NCT02915016 (Archived by WebCite at http://www.webcitation.org/71h0cztDM) Registered Report Identifier: RR1-10.2196/9396

  • Source: Military Health System (LA Shively); Copyright: US Air Force; URL: https://health.mil/News/Articles/2016/10/13/Army-Medicine-fights-cancer-with-advanced-treatments; License: Public Domain (CC0).

    Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY...

    Abstract:

    Background: Breast cancer is the most common cancer among women, and radiotherapy plays a major role in its treatment. However, breast cancer radiotherapy can lead to incidental irradiation of the heart, resulting in an increased risk for a variety of heart diseases arising many years after radiotherapy. Therefore, identifying breast cancer patients at the highest risk for radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy aging. There is still a need for precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence over time that could finally lead to cardiac complications. Objective: The MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising within first 2 years of breast cancer radiotherapy and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on three-dimensional dosimetry. Methods: The EARLY HEART study is a multicenter, prospective cohort study in which 250 women treated for breast cancer and followed for 2 years after radiotherapy will be included. Women treated with radiotherapy without chemotherapy for a unilateral breast cancer and aged 40-75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on two-dimensional speckle-tracking echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging, and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose will be evaluated globally for the heart and different substructures. Furthermore, the dose-response relationship will allow modeling the radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers to develop prediction models. Results: This study details the protocol of the MEDIRAD EARLY HEART study and presents the main limits and advantages of this international project. The inclusion of patients began in 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021. Conclusions: The MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patient care and quality of life. Trial Registration: ClinicalTrials.gov NCT03297346; https://clinicaltrials.gov/ct2/show/NCT03297346 (Archived by WebCite at http://www.webcitation.org/72KS7MIUU) Registered Report Identifier: RR1-10.2196/9906

  • Woman in front of computer using social media. Source: Pixnio; Copyright: Walton LaVonda; URL: https://pixnio.com/people/female-women/girl-with-computer-emerging-technologies-social-media; License: Public Domain (CC0).

    Monitoring Twitter Conversations for Targeted Recruitment in Cancer Trials in Los Angeles County: Protocol for a Mixed-Methods Pilot Study

    Abstract:

    Background: Insufficient recruitment of participants remains a critical roadblock to successful clinical research, particularly clinical trials. Social media provide new ways for connecting potential participants with research opportunities. Researchers suggest that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. Objective: This pilot study aimed to examine the feasibility and impact of using Twitter monitoring data (ie, user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in Los Angeles County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. Methods: We will conduct a mixed-methods interrupted time series study design with a before-and-after social media recruitment intervention. On the basis of a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across 6 disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the University of Southern California (USC) Norris Comprehensive Cancer Center. We will monitor messages about these 6 cancer conditions posted by Twitter users in Los Angeles County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes—feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials—will be assessed using qualitative interviews and the 4-point Likert scale and by calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of enrollees in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. This study has been funded by the National Center for Advancing Translational Science through a Clinical and Translational Science Award. Study approval was obtained from the clinical investigations committee at USC Norris and the institutional review board at USC. Results: Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. Conclusions: This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants across 6 cancer disease types. We will shed light on the acceptance of the social media intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations. Trial Registration: ClinicalTrials.gov NCT03408561; https://clinicaltrials.gov/ct2/show/NCT03408561 (Archived by WebCite at http://www.webcitation.org/72LihauzW) Registered Report Identifier: RR1-10.2196/9762

  • Mobile apps for the geriatric care. Source: SMOA; Copyright: SMOA; URL: https://smoa2016.weebly.com/; License: Fair use/fair dealings.

    Development of a Path to Home Mobile App for the Geriatric Rehabilitation Program at Bruyère Continuing Care: Protocol for User-Centered Design and...

    Abstract:

    Background: As the population ages, the need for appropriate geriatric rehabilitation services will also increase. Pressures faced by hospitals to reduce length of stay and reduce costs have driven the need for more complex care being delivered in the home or community setting. As a result, a multifaceted approach that can provide geriatric rehabilitation patients with safe and effective person- and family-centered care during transitions from hospital to home is required. We hypothesize that a technology-supported person- and family-centered care transition could empower geriatric rehabilitation patients, engage them in shared decision making, and ultimately help them to safely manage their personalized needs during care transitions from hospital to home. Objective: The purpose of this study is to design and test the feasibility of a novel Path to Home mobile app to manage the personalized needs of geriatric rehabilitation patients during their transitions from hospital to home. Methods: This study will consist of (1) codesigning a patient- and provider-tailored mobile app, and (2) feasibility pilot testing of the mobile app to manage the needs of geriatric rehabilitation patients when leaving the hospital. In phase 1, we will follow a user-centered design process integrated with a modern agile software development methodology to iteratively codesign the personalized care transition Path to Home mobile app. In phase 2, we will conduct a single-arm feasibility pilot test with geriatric rehabilitation patients using the personalized care transition Path to Home mobile app to manage their needs during the transition from hospital to home. Results: The project was funded in May 2018, and enrollment and data analysis are underway. First results are expected to be submitted for publication in 2019. Conclusions: Our findings will help validate the use of this technology for geriatric rehabilitation patients discharged from the hospital to home. Future research will more rigorously evaluate the health and economic benefits to inform wide-scale adoption of the technology. Registered Report Identifier: RR1-10.2196/11031

  • Patient accesses MijnZorgnet, a Web-based personal health record system (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/9/e10193/; License: Creative Commons Attribution (CC-BY).

    Use and Effects of Patient Access to Medical Records in General Practice Through a Personal Health Record in the Netherlands: Protocol for a Mixed-Methods Study

    Abstract:

    Background: In the Dutch health care system, general practitioners hold a central position. They store information from all health care providers who are involved with their patients in their electronic health records. Web-based access to the summary record in general practice through a personal health record (PHR) may increase patients’ insight into their medical conditions and help them to be involved in their care. Objective: We describe the protocol that we will use to investigate the utilization of patients’ digital access to the summary of their medical records in general practice through a PHR and its effects on the involvement of patients in their care. Methods: We will conduct a multilevel mixed-methods study in which the PHR and Web-based access to the summary record will be offered for 6 months to a random sample of 500 polypharmacy patients, 500 parents of children aged <4 years, and 500 adults who do not belong to the former two groups. At the patient level, a controlled before-after study will be conducted using surveys, and concurrently, qualitative data will be collected from focus group discussions, think-aloud observations, and semistructured interviews. At the general practice staff (GP staff) level, focus group discussions will be conducted at baseline and Q-methodology inquiries at the end of the study period. The primary outcomes at the patient level are barriers and facilitators for using the PHR and summary records and changes in taking an active role in decision making and care management and medication adherence. Outcomes at the GP staff level are attitudes before and opinions after the implementation of the intervention. Patient characteristics and changes in outcomes related to patient involvement during the study period will be compared between the users and nonusers of the intervention using chi-square tests and t tests. A thematic content analysis of the qualitative data will be performed, and the results will be used to interpret quantitative findings. Results: Enrollment was completed in May 2017 and the possibility to view GP records through the PHR was implemented in December 2017. Data analysis is currently underway and the first results are expected to be submitted for publication in autumn 2019. Conclusions: We expect that the findings of this study will be useful to health care providers and health care organizations that consider introducing the use of PHR and Web-based access to records and to those who have recently started using these. Trial Registration: Netherlands Trial Registry NTR6395; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6395 (Archived by WebCite at http://www.webcitation.org/71nc8jzwM) Registered Report Identifier: RR1-10.2196/10193

  • Source: PanCareLIFE; Copyright: The PanCareLIFE Consortium; URL: http://pancarelife.eu; License: Licensed by JMIR.

    Fertility Among Female Survivors of Childhood, Adolescent, and Young Adult Cancer: Protocol for Two Pan-European Studies (PanCareLIFE)

    Abstract:

    Background: Despite a significant number of studies on female fertility following childhood, adolescent, and young adult (CAYA) cancer, studies establishing precise (dose-related) estimates of treatment-related risks are still scarce. Previous studies have been underpowered, did not include detailed treatment information, or were based on self-report only without any hormonal assessments. More precise assessments of who is at risk for sub- or infertility are needed. Objective: The objective of our study is to describe the design and methods of 2 studies on female fertility (a cohort study and a nested case-control study) among female survivors of CAYA cancer performed within the European PanCareLIFE project. Methods: For the cohort study, which aims to evaluate the overall risk of fertility impairment, as well as the risk for specific subgroups of female CAYA cancer survivors, 13 institutions from 9 countries provide data on fertility impairment. Survivors are defined as being fertility impaired if they meet at least one of 8 different criteria based on self-reported and hormonal data. For the nested case-control study, which aims to identify specific treatment-related risk factors associated with fertility impairment in addition to possible dose-response relationships, cases (fertility impaired survivors) are selected from the cohort study and matched to controls (survivors without fertility impairment) on a 1:2 basis. Results: Of the 10,964 survivors invited for the cohort study, data are available from 6619 survivors, either questionnaire-based only (n=4979), hormonal-based only (n=72), or both (n=1568). For the nested case-control study, a total of 450 cases and 882 controls are identified. Conclusions: Results of both PanCareLIFE fertility studies will provide detailed insight into the risk of fertility impairment following CAYA cancer and diagnostic- or treatment-related factors associated with an increased risk. This will help clinicians to adequately counsel both girls and young women, who are about to start anticancer treatment, as well as adult female CAYA cancer survivors, concerning future parenthood and to timely refer them for fertility preservation. Ultimately, we aim to empower patients and survivors and improve their quality of life. Registered Report Identifier: RR1-10.2196/10824

  • Source: Pexels; Copyright: Pixabay; URL: https://www.pexels.com/photo/medical-tablets-pharmacy-cure-51004/; License: Public Domain (CC0).

    Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention

    Abstract:

    Background: Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. Objective: This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. Methods: We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. Results: Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type–specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. Conclusions: Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. Registered Report Identifier: RR1-10.2196/10163

  • Source: Freepik; Copyright: sirinarth; URL: https://www.freepik.com/free-photo/young-woman-using-computer-on-green-glasses-in-the-park_1236208.htm#term=teenager%20laptop&page=9&position=16; License: Licensed by JMIR.

    An e-Prehabilitation System of Care for Teenagers and Young Adults Diagnosed With Cancer: Protocol for a Qualitative Co-Design Study

    Abstract:

    Background: A diagnosis of cancer in young adulthood can pose many different and unique challenges for individuals. The provision of adequate and appropriate information as well as care and support for teenagers and young adults at the time of diagnosis is central to their health care experience going forward. Moreover, appropriate and accessible information provision is critical to ensure that young individuals with cancer feel equipped and empowered to make decisions about, and be involved in, their treatment and recovery throughout their experience; this is a concept known as prehabilitation. As digital interventions and resources that support teenagers and young adults with cancer are an increasingly desirable part of health care provision, this study will focus on the development of an age- and population-appropriate electronic prehabilitation (e-Prehabilitation) system of care. Objective: We will conduct an exploratory, co-design research project that will inform the development of an e-Prehabilitation system of care to support teenagers and young adults diagnosed with cancer. A collaborative approach to data collection and prototype design will ensure that a patient-centered approach is embedded throughout. Methods: A qualitative, co-design study utilizing surveys, interviews, and focus group discussions is being conducted with teenagers and young adults, health care professionals, and technologists. Results: This research study is in progress; recruitment and data collection activities have commenced and findings are expected in early 2019. Conclusions: The findings of this study will have important implications for informing the future development and evaluation of an e-Prehabilitation system of care to support teenagers and young adults diagnosed with cancer. Registered Report Identifier: RR1-10.2196/10287

  • SCIPUD+ care plan model (concept). Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/9/e10871/; License: Creative Commons Attribution (CC-BY).

    Individualized Clinical Practice Guidelines for Pressure Injury Management: Development of an Integrated Multi-Modal Biomedical Information Resource

    Abstract:

    Background: Pressure ulcers (PU) and deep tissue injuries (DTI), collectively known as pressure injuries are serious complications causing staggering costs and human suffering with over 200 reported risk factors from many domains. Primary pressure injury prevention seeks to prevent the first incidence, while secondary PU/DTI prevention aims to decrease chronic recurrence. Clinical practice guidelines (CPG) combine evidence-based practice and expert opinion to aid clinicians in the goal of achieving best practices for primary and secondary prevention. The correction of all risk factors can be both overwhelming and impractical to implement in clinical practice. There is a need to develop practical clinical tools to prioritize the multiple recommendations of CPG, but there is limited guidance on how to prioritize based on individual cases. Bioinformatics platforms enable data management to support clinical decision support and user-interface development for complex clinical challenges such as pressure injury prevention care planning. Objective: The central hypothesis of the study is that the individual’s risk factor profile can provide the basis for adaptive, personalized care planning for PU prevention based on CPG prioritization. The study objective is to develop the Spinal Cord Injury Pressure Ulcer and Deep Tissue Injury (SCIPUD+) Resource to support personalized care planning for primary and secondary PU/DTI prevention. Methods: The study is employing a retrospective electronic health record (EHR) chart review of over 75 factors known to be relevant for pressure injury risk in individuals with a spinal cord injury (SCI) and routinely recorded in the EHR. We also perform tissue health assessments of a selected sub-group. A systems approach is being used to develop and validate the SCIPUD+ Resource incorporating the many risk factor domains associated with PU/DTI primary and secondary prevention, ranging from the individual’s environment to local tissue health. Our multiscale approach will leverage the strength of bioinformatics applied to an established national EHR system. A comprehensive model is being used to relate the primary outcome of interest (PU/DTI development) with over 75 PU/DTI risk factors using a retrospective chart review of 5000 individuals selected from the study cohort of more than 36,000 persons with SCI. A Spinal Cord Injury Pressure Ulcer and Deep Tissue Injury Ontology (SCIPUDO) is being developed to enable robust text-mining for data extraction from free-form notes. Results: The results from this study are pending. Conclusions: PU/DTI remains a highly significant source of morbidity for individuals with SCI. Personalized interactive care plans may decrease both initial PU formation and readmission rates for high-risk individuals. The project is using established EHR data to build a comprehensive, structured model of environmental, social and clinical pressure injury risk factors. The comprehensive SCIPUD+ health care tool will be used to relate the primary outcome of interest (pressure injury development) with covariates including environmental, social, clinical, personal and tissue health profiles as well as possible interactions among some of these covariates. The study will result in a validated tool for personalized implementation of CPG recommendations and has great potential to change the standard of care for PrI clinical practice by enabling clinicians to provide personalized application of CPG priorities tailored to the needs of each at-risk individual with SCI. Registered Report Identifier: RR1-10.2196/10871

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    Open Peer Review Period: Oct 14, 2018 - Oct 19, 2018

    Background: Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Under...

    Background: Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Understanding the specific mechanisms responsible for the beneficial metabolic effects will help to engineer ways to improve the procedure or produce these effects without surgery. Objective: The focus of this report is a translational study, designed to test a hypothesis for the mechanisms underlying the improvement in T2DM following gastric bypass that involves specific changes in the post-surgical, short- and long-term metabolism and morphology of the jejunum (Roux limb). Specifically to test whether the intestine enhances its metabolism and activity after gastric bypass and increases its fuel utilization, we designed a prospective, longitudinal study, which involved the recruitment of bariatric bypass surgery candidates with and without T2DM. We describe the tissue bank that we have generated and we discuss in detail our experience, hoping to further facilitate the performance of longitudinal mechanistic studies in human patients undergoing bariatric surgery and especially those involving methods examining the post-bypass intestinal biology. Methods: We designed and conducted a clinical trial (clinicaltrials.gov ID NCT02710370) aiming to characterize the effects of RYGB on intestinal metabolism. Intestinal tissue samples were collected from the jejunum at surgery, 1, 6, and 12 months post operatively for analysis of intestinal gene expression, metabolomic and morphologic changes. The target number of patients with completed at least the 6-month follow up was 26 and we included a 20% attrition rate increasing the total number to 32. Results: To enroll 26 patients, we had to approach 79 potential participants. 37 agreed to participate and started the study. 33 active participants completed their 1 month, 30 their 6 month and 26 their 12 month studies. Three participants withdrew and 30 participants are still active. Altruism and interest in research were the most common reasons for participation. Important factors for feasibility and successful retention included: 1) large volume case flow, 2) inclusion and exclusion criteria broad enough to capture a large segment of the patient population, but narrow enough to ensure completing study aims and protecting safety concerns, 3) accurate assessment of willingness and motivation to participate in a study, 4) seamless integration of the recruitment process into normal clinical flow, 5) financial reimbursement and non-financial rewards and gestures of appreciation and 6) non-burdensome follow-up visits and measures and reasonable time allotted. Conclusions: Human translational studies of the intestinal mechanisms of metabolic and weight change after bariatric surgery are both important and feasible. A tissue bank with unique samples has been established that could be used by investigators in many research fields further enabling mechanistic studies on the effects of bariatric surgery. Clinical Trial: Clinicaltrials.gov ID NCT02710370

  • A randomized controlled pilot study of a sleep self-management intervention in pregnancy using a personalized health-monitoring device: rationale and protocol

    Date Submitted: Oct 10, 2018

    Open Peer Review Period: Oct 12, 2018 - Oct 26, 2018

    BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean b...

    BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitoring (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. OBJECTIVE: To describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability and preliminary efficacy of using a PHM device (Misfit Shine 2) to promote sleep during pregnancy. METHODS: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at 1:1 ratio into a 12-week sleep education plus PHM device or sleep education alone comparison group. The primary outcomes will be measures of feasibility (i.e., recruitment, enrollment, adherence) and acceptability (i.e., participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, depressive symptoms, and birth outcomes (e.g., delivery methods). DISCUSSION: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions as they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women.

  • Using text messaging to promote mental health among university students: Protocol for a Randomized Controlled Trial of a mobile-phone based intervention.

    Date Submitted: Oct 4, 2018

    Open Peer Review Period: Oct 8, 2018 - Oct 22, 2018

    Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and men...

    Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and mental illness and increased longevity. Objective: This randomized controlled trial aims to test the efficacy of a mobile phone based intervention on positive mental health. Methods: Two-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (e.g. university websites). Participants will be randomly allocated to either an intervention (fully automated mobile-phone based mental health intervention) or control group (treatment as usual). The Primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form, MHC-SF). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale), emotional well-being, psychological functioning and social well-being (MHC-SF). Outcomes will be investigated at baseline, at 3- 6- and 12 months follow-up. Mediators (positive emotions and cognitions) will be investigated at baseline, mid-intervention and at 3 months follow-up using two single face-valid items. Results: Recruitment of participants will begin in mid-October 2018. Discussion: This study will add knowledge to the efficacy of a fully automated positive psychology intervention. Strengths and limitations of the study are discussed.

  • Randomised controlled trial evaluating the effectiveness of a self-regulation-based eHealth intervention targeting an active lifestyle in adults with type 2 diabetes: study protocol

    Date Submitted: Oct 4, 2018

    Open Peer Review Period: Oct 6, 2018 - Oct 20, 2018

    Background Adopting an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes render mixed resu...

    Background Adopting an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes render mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention ‘MyPlan 2.0’ targets physical activity and sedentary behaviour in adults with type 2 diabetes. ‘MyPlan 2.0’ is grounded in self-regulation theory and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective The goal of this paper is to thoroughly describe ‘MyPlan 2.0’ and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behaviour. Methods A superiority two-arm randomized controlled trial will be performed. Physical activity and sedentary behaviour will be measured via accelerometers and questionnaires. Furthermore, via questionnaires and diaries patients’ stressors and personal determinants for change will be explored in-depth. To evaluate the primary outcomes of the intervention multilevel analyses will be conducted. Conclusions This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes to increase their level of physical activity and decrease their sedentary time.

  • Explore Short Message Service (SMS) to Assess Depression and Related Conditions in Low-Income, Ethnically Diverse Patients with Diabetes: Design of a Randomized Study

    Date Submitted: Oct 2, 2018

    Open Peer Review Period: Oct 6, 2018 - Oct 20, 2018

    Background: Depression is an often under-diagnosed and therefore untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent update of...

    Background: Depression is an often under-diagnosed and therefore untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent update of the U.S. Preventive Services Task Force guideline in 2016 recommends assessing depression for every adult. Short Message Service (SMS) is an inexpensive, private, and scalable approach to provide depression screening and monitoring, and it can alleviate many barriers such as transportation, childcare, and clinical visit time faced by low-income population to receive depression diagnosis. Current evidence is inconsistent in comparing technology-mediated assessment vs. interviewer (INTW) assessment in collecting sensitive health information, as some studies suggest technology encourages self-disclosure while the other studies show the opposite effect. Objective: The proposed study will test using SMS to assess depression and its related conditions, including functional disability, pain, and anxiety, in low-income, culturally diverse safety-net primary care populations with diabetes. The study will examine the concordance between SMS and INTW assessments and evaluate test-retest reliability. Methods: The proposed study is a randomized trial with 200 patients with four study groups: SMS/INTW, INTW/SMS, SMS/SMS, INTW/INTW. The first two groups will be used to examine the concordance between SMS and INTW assessments. The third and fourth groups will be used to evaluate test-retest reliability. Participants of the study will be recruited from the participants of the prior Diabetes-depression Care-management Trial, a large comparative effectiveness research in collaboration with the Los Angeles County Department of Health Services (LAC-DHS). Concordance between SMS and INTW assessments will be evaluated by interclass correlation coefficient and Kappa statistic. Test-retest reliability will be measured by Cronbach’s alpha. Missing data patterns will be explored to understand whether participants are willing to self-disclose such information in SMS assessment. Results: Recruitment of participants was conducted from June, 2017 to November, 2017. A total of 206 participants were enrolled: 52 in SMS/INTW, 53 in SMS/SMS, 49 in INTW/SMS, 52 in INTW/INTW. Average age of the participants was 57.1. 57.8% (119/206) were female. 93.2% (192/206) were Latinos. And, 77.7% (160/206) chose Spanish as their preferred language. Test of the SMS assessment shows the cost of distributing the 16 questions is about $0.50 per person per time. Full results of the study will be reported elsewhere. Conclusions: The study is anticipated to establish feasibility of using SMS to assess depression and its related conditions in low-income, culturally diverse safety-net primary care populations with diabetes. We also expect to generate knowledge about whether patients in the targeted population are willing to reply and self-disclose the sensitive information about depression and its related conditions through SMS assessments.

  • Model-based methods to translate Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) findings into policy recommendations: Rationale and Protocol for a Modeling Core (ATN 161)

    Date Submitted: Sep 27, 2018

    Open Peer Review Period: Oct 6, 2018 - Oct 20, 2018

    Background: The United States (US) Centers for Disease Control and Prevention (CDC) estimates that approximately 60,000 US youth are living with Human Immunodeficiency Virus (HIV). US youth living wit...

    Background: The United States (US) Centers for Disease Control and Prevention (CDC) estimates that approximately 60,000 US youth are living with Human Immunodeficiency Virus (HIV). US youth living with HIV (YLWH) have poorer outcomes compared to adults [1]. With Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) support, new trials of youth-centered interventions to improve retention in care and medication adherence among YLWH are underway. Objective: Our objective is to use a computer simulation model, the Cost-effectiveness of Preventing AIDS Complications (CEPAC) - Adolescent Model, to evaluate selected ongoing and forthcoming ATN interventions to improve viral load suppression among YLWH and to define the benchmarks for uptake, effectiveness, durability of effect, and cost that will make these interventions clinically beneficial and cost-effective. Methods: This protocol, ATN 161, establishes the ATN Modeling Core. The Modeling Core leverages extensive data - already collected by successfully completed National Institute of Health (NIH)-supported studies - to develop novel approaches for modeling critical components of HIV disease and care in YLWH. As new data emerge from ATN trials during the award period about the effectiveness of these interventions, the CEPAC-Adolescent simulation model will serve as a flexible tool to project their long-term clinical impact and cost-effectiveness. The Modeling Core will derive model data input parameters and create model structure to reflect key aspects of HIV acquisition, progression, and treatment in YLWH. The ATN Modeling Core Steering Committee, with guidance from ATN leadership and scientific experts, will select model-based analyses to prioritize, as well as provide feedback on derivation of model input parameters and model assumptions. Project-specific teams will help frame research questions for model-based analyses, as well as provide feedback regarding project specific inputs, results, sensitivity analyses and policy conclusions. Results: N/A Conclusions: The ATN Modeling Core will provide critical information to guide the scale-up of ATN interventions and the translation of ATN data into policy recommendations for YLWH in the United States.

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