The Karma system is currently undergoing maintenance (Monday, January 29, 2018).
The maintenance period has been extended to 8PM EST.

Karma Credits will not be available for redeeming during maintenance.
Advertisement

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:

  • Focus groups for health information technology implementation strategies. Source: Pexels; Copyright: Rawpixels.com; URL: https://www.pexels.com/photo/people-in-a-mashroom-6-engaging-in-a-meeting-1243485/; License: Public Domain (CC0).

    Virtual Medical Modality Implementation Strategies for Patient-Aligned Care Teams to Promote Veteran-Centered Care: Protocol for a Mixed-Methods Study

    Abstract:

    Background: The Veterans Health Administration (VHA) is making system-wide efforts to increase integrated use of health information technology (HIT), including My HealtheVet (MHV), the Veterans Affairs (VA) electronic patient portal, Vet Link kiosks, telehealth, and mobile apps. Integrated use of HIT can increase individual and system efficiency, maximize resources, and enhance patient outcomes. Prior research indicates that provider endorsement and reinforcement are key determinants of patient adoption of HIT. HIT implementation strategies need to reflect providers’ perspectives to promote adoption and endorsement of these tools; however, providers often lack awareness or are unmotivated to incorporate HIT into clinical care with their patients. When these modalities are used by patients, the approach is often fragmented rather than integrated within and across care settings. Research is needed to identify effective implementation strategies for increasing patient-aligned care team (PACT) member (ie, the VHA’s Patient Centered Medical Home) awareness and motivation to use HIT in a proactive and integrated approach with patients. Objective: This paper describes the rationale, design, and methods of the PACT protocol to promote proactive integrated use of HIT. Methods: In Aim 1, focus groups (n=21) were conducted with PACT members (n=65) along with questionnaires and follow-up individual interviews (n=16). In Aim 2, the team collaborated with VA clinicians, electronic health researchers and operational partners to conduct individual expert interviews (n=13), and an environmental scan to collect current and emerging provider-focused implementation tools and resources. Based on Aim 1 findings, a gap analysis was conducted to determine what implementation strategies and content needed to be adapted or developed. Following the adaptation or development of resources, a PACT expert panel was convened to evaluate the resultant content. In Aim 3, a local implementation of PACT-focused strategies to promote integrated use of HIT was evaluated using pre- and postquestionnaire surveys, brief structured interviews, and secondary data analysis with PACT members (n=63). Results: Study enrollment for Aim 1 has been completed. Aims 1 and 2 data collection and analysis are underway. Aim 3 activities are scheduled for year 3. Conclusions: This work highlights the practical, technological, and participatory factors involved in facilitating implementation research designed to engage PACT clinical members in the proactive integrated use of HIT. These efforts are designed to support the integrated and proactive use of VA HIT to support clinical care coordination in ways that are directly aligned with PACT member preferences. This study evaluated integrated VA HIT use employing mixed-methods and multiple data sources. Deliverables included PACT-focused strategies to support integrated use of HIT in the ambulatory care setting that will also inform strategy development in other systems of care and support subsequent implementation efforts at regional and national levels. Registered Report Identifier: RR1-10.2196/11262

  • Study logo. Source: BTG International Group Companies; Copyright: BTG International Group Companies; URL: http://www.researchprotocols.org/2018/8/e11234; License: Licensed by the authors.

    Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC...

    Abstract:

    Background: Globally, hepatocellular carcinoma is the second most common cause of cancer deaths. It remains challenging to intensify cancer treatment without impairing liver function. Objective: The objective of the TheraSphere in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (STOP-HCC) study is to examine the hypothesis that transarterial radioembolization (TheraSphere yttrium-90 glass microspheres) combined with standard first-line treatment with sorafenib will improve outcomes over treatment with sorafenib alone in unresectable hepatocellular carcinoma. The STOP-HCC study is the largest international, multicenter, prospective study of intra-arterial treatment in combination with sorafenib in unresectable hepatocellular carcinoma. Here we report the study design. Methods: STOP-HCC is a prospective, phase 3, open-label, randomized controlled study conducted across up to 105 sites in North America, Europe, and Asia. Eligible adults have unresectable hepatocellular carcinoma and a life expectancy of at least 12 weeks, 1 or more unidimensional measurable lesions, Child-Pugh score 7 points or less, and Eastern Cooperative Oncology Group Performance Status score 1 or lower, and are candidates for treatment with sorafenib. Presence of branch portal vein tumor thrombosis is permitted. Patients were randomly assigned in a 1:1 ratio to receive either sorafenib alone or transarterial radioembolization followed by sorafenib within 2 to 6 weeks. The primary outcome is overall survival. Secondary outcomes are time to progression, time to untreatable progression, time to symptomatic progression, tumor response, quality of life, and adverse event occurrence. The study is an adaptive trial, comprising a group-sequential design with 2 interim analyses with 520 patients, and an option to increase the sample size to 700 patients at the second interim analysis. The sample size of 520 patients allows for 417 deaths to give 80% power to detect an increase in median overall survival from 10.7 months for the sorafenib group (based on the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol [SHARP] trial) to 14.2 months for the transarterial radioembolization+sorafenib group (hazard ratio 0.754) with 2-sided alpha of .05. The increased sample size of 700 patients allows for 564 deaths to give 80% power to detect a smaller difference in median overall survival from 10.7 months for the sorafenib group to 13.7 months for the transarterial radioembolization+sorafenib group (hazard ratio 0.781). Results: Enrollment for the study completed in September 2017. Results of the first and second interim analyses were reviewed by the Independent Data Monitoring Committee. The recommendation of the committee, at both interim analyses, was to continue the study without any changes. Conclusions: The STOP-HCC study will contribute toward the establishment of the role of combination therapy with transarterial radioembolization and sorafenib in the treatment of unresectable hepatocellular carcinoma with and without branch portal vein tumor thrombosis. Trial Registration: ClinicalTrials.gov NCT01556490; https://clinicaltrials.gov/ct2/show/NCT01556490 (Archived by WebCite at http://www.webcitation.org/7188iygKs). Registered Report Identifier: RR1-10.2196/11234

  • Source: Shutterstock; Copyright: bitt24; URL: https://www.shutterstock.com/image-photo/best-foods-healthy-heart-on-wooden-451313305; License: Licensed by the authors.

    A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive...

    Abstract:

    Background: A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer disease and other forms of dementia in at-risk individuals. The development of internet-delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar effectiveness to brick-and-mortar options. Objective: We describe the study design, recruitment process, and baseline participant characteristics of the sample in the Virtual Cognitive Health (VC Health) study. Future analyses will assess the impact of the remotely delivered lifestyle intervention on (1) cognitive function, (2) depression and anxiety, and (3) various lifestyle behaviors, including diet, exercise, and sleep, in a cohort of older adults with subjective memory decline. Additional analyses will explore feasibility outcomes, as well as the participants’ engagement patterns with the program. Methods: Older adults (aged 60-75 years) with subjective memory decline as measured by the Subjective Cognitive Decline 9-item (SCD-9) questionnaire, and who reported feeling worried about their memory decline, were eligible to participate in this single-arm pre-post study. All participants enrolled in the yearlong digital intervention, which consists of health coach-guided lifestyle change for improving diet, exercise, sleep, stress, and cognition. All components of this study were conducted remotely, including the collection of data and the administration of the intervention. We assessed participants at baseline, 12 weeks, 24 weeks, and 52 weeks with online surveys and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test. We will conduct intention-to-treat analysis on all outcomes. Results: A total of 85 participants enrolled in the intervention and 82 are included in the study sample (3 participants withdrew). The study cohort of 82 participants comprises 61 (74%) female, 72 (88%) white, and 64 (78%) overweight or obese participants, and 55 (67%) have at least a college degree. The average baseline RBANS score was 95.9 (SD 11.1), which is within age-adjusted norms. The average SCD-9 score was 6.0 (SD 2.0), indicating minor subjective cognitive impairment at the beginning of the study. The average baseline Generalized Anxiety Disorder 7-item scale score was 6.2 (SD 4.5), and the average Patient Health Questionnaire 9-item score was 8.5 (SD 4.9), indicating mild levels of anxiety and depression at baseline. Conclusions: Internet-delivered lifestyle interventions are a scalable solution for the prevention or delay of Alzheimer disease. The results of this study will provide the first evidence for the effectiveness of a fully remote intervention and lay the groundwork for future investigations. Trial Registration: ClinicalTrials.gov NCT02969460; http://clinicaltrials.gov/ct2/show/NCT02969460 (Archived by WebCite at http://www.webcitation.org/71LkYAkSh) Registered Report Identifier: RR1-10.2196/11368

  • A couple using DemPower. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/8/e171/; License: Creative Commons Attribution (CC-BY).

    Designing and Implementing a Home-Based Couple Management Guide for Couples Where One Partner has Dementia (DemPower): Protocol for a Nonrandomized...

    Abstract:

    Background: The increasing rate of dementia and high health and social care costs call for effective measures to improve public health and enhance the wellbeing of people living with dementia and their relational networks. Most postdiagnostic services focus on the condition and the person with dementia with limited attention to the caring spouse or partner. The key focus of the study is to develop a guide for couples where one partner has a diagnosis of dementia. This couple management guide is delivered in the form of an app, DemPower. Objective: This study aims to investigate the feasibility and acceptability of DemPower and to assess the criteria for a full-integrated clinical and economic randomized control trial. DemPower couple management app will be introduced to couples wherein one partner has dementia. Methods: The study will recruit 25 couples in the United Kingdom and 25 couples in Sweden. Couples will be given 3 months to engage with the app, and the amount of time taken to complete the guide (can be <3 or >3 months) will be reviewed. A set of outcome measures will be obtained at baseline and postintervention stages. Results: The proposed study is at the recruitment phase. The DemPower app is being introduced to couples from consultation groups at a pretrial phase for identifying any bugs and exploring if any navigation challenges exist. The feasibility testing will begin in April 2018. Conclusions: The study will determine how much support couples need to engage with DemPower and whether or not they make use of it in their everyday lives. If there is support for app use, a future study will assess whether it is superior to “usual care.” Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 10122979; http://www.isrctn.com/ISRCTN10122979 (Archived by WebCite at http://www.webcitation.org/70rB1iWYI) Registered Report Identifier: RR1-10.2196/9087

  • Complexity of the balance between beneficial cardiovascular effects of aspirin in patients with end-stage renal disease and its toxicity related to bleeding events. Source: Image created by Nathalie M Vandevelde; Copyright: Nathalie M Vandevelde; URL: http://www.researchprotocols.org/2018/8/e10516/; License: Creative Commons Attribution (CC-BY).

    The Use of Aspirin to Reduce the Risk of Thrombotic Events in Patients With End-Stage Renal Disease: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin’s efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Objective: The overall objective of this protocol is to (1) evaluate aspirin’s safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin’s efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. Methods: We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. Results: The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov. Conclusions: We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events. Registered Report Identifier: RR1-10.2196/10516

  • Source: Wikimedia Commons; Copyright: Skincareaus; URL: https://commons.wikimedia.org/wiki/File:Trusted_Mole_Check_Clinic_in_Australia.jpg; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Evaluating the Diagnostic Accuracy of Reflectance Confocal Microscopy to Diagnose Skin Cancer: Protocol for a Prospective, Multicenter Study

    Abstract:

    Background: In the United Kingdom, 350,000 patients per year are referred to hospital clinics with suspicious moles, and approximately half undergo a biopsy to identify the 5%-10% who require further treatment. If cancer cannot be ruled out clinically and on the basis of biopsy results, the lesion is surgically removed. One type of precancerous mole, called lentigo maligna, is particularly challenging to delineate and treat. Reflectance confocal microscopy (VivaScope, Caliber Imaging & Diagnostics) is an imaging technique that can supplement dermoscopy in identifying whether a clinically suspicious mole is malignant and can better assess lentigo maligna margins for excision. It allows clinicians to visualize the skin lesion to a depth of 200 microns with subcellular resolution, described as quasi-histological, and therefore better guide more accurate diagnoses. Objective: The aim of this paper is to describe a prospective, single blinded, multicenter study to examine patients with clinically suspicious moles or lentigo maligna to determine whether confocal microscopy can both reduce the number of unnecessary biopsies of moles and more accurately guide the surgical excision margins of lentigo maligna. Methods: This study will prospectively recruit adults into the following two cohorts: diagnostic accuracy and margin delineation. The diagnostic accuracy cohort will assess people with clinically suspicious lesions suspected of being diagnosed with melanoma and having an equivocal finding on dermoscopy or persistent clinical suspicion despite normal dermoscopy. Diagnostic accuracy will include the sensitivity and specificity of VivaScope in comparison with the histological diagnosis as the gold standard for patients. The margin delineation cohort will assess the ability of VivaScope to accurately delineate the margins of lentigo maligna compared with that of dermoscopy alone using margins taken during Mohs micrographic surgery as the gold standard. The primary study outcomes will be the diagnostic accuracy of VivaScope for the first cohort of patients and margin agreement between VivaScope and the final pathology report for the second cohort of patients. Results: Funding for this proposed research is being secured. Conclusions: The outcomes of the proposed study will indicate how many biopsies of nonmelanoma lesions, which are potentially unnecessary, could be prevented. This would reduce patient anxiety and cost to the National Health Service (NHS) in the United Kingdom. Improved margin delineation of lentigo maligna could also improve the surgical clearance rates and decrease overall cost. The results would demonstrate whether the adoption of VivaScope would potentially benefit patients and the NHS. Registered Report Identifier: RR1-10.2196/9296

  • Example of a web-based visual probe task for the retraining of biases amongst individuals with addictive disorders. Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/8/e10427/; License: Creative Commons Attribution (CC-BY).

    Web-Based Cognitive Bias Intervention for Psychiatric Disorders: Protocol for a Systematic Review

    Abstract:

    Background: Traditional psychological therapies focus mainly on modification of individuals’ conscious decision-making process. Unconscious processes, such as cognitive biases, have been found accountable for various psychiatric psychopathologies, and advances in technologies have transformed how bias modification programs are being delivered. Objective: The primary aim of this review is to synthesize evidence of Web-based cognitive bias modification intervention for bias reduction. The secondary aim is to determine the change in symptoms for individual psychiatric disorders following bias modification. Methods: A systematic review will be conducted including only randomized trials. There will be no restrictions on participants included in the study. A search will be conducted on the respective databases until 2017. Selection of studies will be by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA-P) guidelines. Quality assessment of included studies will be conducted using the Cochrane Risk of Bias tool. A narrative synthesis of identified articles will then be conducted. A meta-analysis will be considered only if there are sufficient articles in a domain for statistical analysis. Ethical approval for this protocol and the planned systematic review was not required. Results: We expect that the review will be completed 12 months from publication of this protocol. Conclusions: This review is of importance given how technology has transformed delivery of conventional therapies. Findings from this review will guide future research involving technology and cognitive bias modification interventions. Trial Registration: International Prospective Register for Systematic Reviews (PROSPERO): 2017 CRD42017074754; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=74754 (Archived by WebCite at http://www.webcitation.org/ 71AvSgZGn) Registered Report Identifier: RR1-10.2196/10427

  • Source: pxhere; Copyright: Mohamed Hassan; URL: https://pxhere.com/it/photo/1439295; License: Public Domain (CC0).

    Technologies for Innovative Monitoring to Reduce Blood Pressure and Change Lifestyle Using Mobile Phones in Adult and Elderly Populations (TIM Study):...

    Abstract:

    Background: Hypertension is a growing problem worldwide, markedly in low- and middle-income countries, where the rate of control slightly decreased. The overall prevalence of hypertension in Brazil is 28.7% among adult individuals and 68.9% in the population aged 60 years and older, and less than a third of patients have controlled blood pressure (BP). The use of technologies—mobile phones and the internet—to implement interventions to reduce blood pressure can minimize costs and diminish cardiovascular risk. Interventions through text messaging and electronic BP monitoring present divergent results. Objective: This trial evaluates the effectiveness of interventions—personalized messages and telemonitoring of BP—to reduce systolic BP and improve lifestyle compared to the usual care of patients with hypertension (control group). Methods: This factorial randomized controlled trial enrolls individuals aged 30 to 75 years who have a mobile phone and internet access with the diagnosis of hypertension under drug treatment with up to 2 medications and uncontrolled BP. Eligible participants should have both increased office BP and 24-hour BP with ambulatory BP monitoring. Participants with severe hypertension (systolic BP ≥180 or diastolic BP ≥110 mm Hg), life threatening conditions, low life expectancy, recent major cardiovascular event (last 6 months), other indications for the use of antihypertensive medication, diagnosis of secondary hypertension, pregnant or lactating women, or those unable to understand the interventions are excluded. Participants are randomly allocate to 1 of 4 experimental arms: (1) Telemonitoring of blood pressure (TELEM) group: receives an automatic oscillometric device to measure BP, (2) telemonitoring by text message (TELEMEV) group: receives personalized, standardized text messages to stimulate lifestyle changes and adhere with BP-lowering medication, (3) TELEM-TELEMEV group: receives both interventions, and (4) control group: receives usual clinical treatment (UCT). Data collection is performed in a clinical research center located in a referent hospital. The primary outcomes are reduction of systolic BP assessed by 24-hour ambulatory BP monitoring (primary outcome) and change of lifestyle (based on dietary approaches to stop hypertension (DASH)-type diet, sodium restriction, weight loss or control, increase of physical activity). Results: This study was funded by two Brazilian agencies: the National Council for Scientific and Technological Development and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul. Enrollment was completed at the end of 2017 (N=231), the follow-up is ongoing, and data analysis is expected to begin in early 2019. A reduction of 24-hour systolic BP of approximately 8.8 [SD 13.1] mm Hg for participants in the BP monitoring group versus 3.4 [SD 11.6] mm Hg in the UCT group is expected. A similar reduction in the text messaging group is expected. Conclusions: The use of mobile technologies connected to the internet through mobile phones promotes time optimization, cost reduction, and better use of public health resources. However, it has not been established whether simple interventions such as text messaging are superior to electronic BP monitoring and whether both outperform conventional counseling. Trial Registration: ClinicalTrials.gov NCT03005470; https://clinicaltrials.gov/ct2/show/NCT03005470 (Archived by WebCite at http://www.webcitation.org/70AoANESu). Plataforma Brasil CAAE 31423214.0.0000.5327. Registered Report Identifier: RR1-10.2196/9619

  • The iTech logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/8/e10365/; License: Licensed by JMIR.

    University of North Carolina/Emory Center for Innovative Technology (iTech) for Addressing the HIV Epidemic Among Adolescents and Young Adults in the United...

    Abstract:

    Background: Over a fifth of all new HIV infections in the United States occur among persons aged 13 24 years, with most of these diagnoses occurring among gay and bisexual males (81%). While the epidemic of HIV in the United States has leveled off for many age groups, the annual number of new HIV diagnoses among young men who have sex with men (YMSM; 13-24 years old) remains high. Traditional approaches to continuum improvement for youth have been insufficient, and targeted interventions are urgently needed for young people at risk for or infected with HIV. Interventions delivered through mobile health technology represent a promising approach for improving outcomes in this population. Mobile phones have nearly reached saturation among youth, making mobile technology a particularly promising tool for reaching this population. Objective: The University of North Carolina/Emory Center for Innovative Technology (iTech) is a National Institutes of Health cooperative agreement as part of the Adolescent Medicine Trials Network for HIV/AIDS Interventions. iTech aims to impact the HIV epidemic by conducting innovative, interdisciplinary research on technology-based interventions across the HIV prevention and care continuum for adolescents and young adults in the United States, particularly YMSM, by providing the following: (1) evaluation of novel approaches to identifying youth with undiagnosed HIV infections; (2) evaluation of multilevel, combination prevention approaches, particularly relevant to gender- and sexual-minority youth facing co-occurring health risks; (3) evaluation of uptake of and adherence to biomedical prevention modalities; and 4) evaluation of interventions designed to promote or optimize engagement in care and antiretroviral therapy adherence in HIV-positive youth, to optimize viral load suppression. Methods: iTech brings together multidisciplinary experts in the fields of adolescent HIV treatment and prevention, development and evaluation of technology-based interventions, HIV surveillance and epidemiology, and intervention design and evaluation. This initiative will support 8 efficacy trials and 2 exploratory projects, each led by 2 principal investigators. Taken together, the studies address all of the key steps of the HIV prevention and care continuum for youth in the United States. Each proposal uses technology in a scientifically rigorous and innovative way to access, engage, and impact at-risk or infected youth. Nine iTech subject recruitment venues are spread across 8 US cities. Three cores (management, analytic, and technology) support all iTech activities and form the research network’s infrastructure, facilitating all aspects of study implementation and evaluation. Results: Formative work has already begun on many of the above-mentioned iTech trials. We expect the first randomized controlled trials to begin in mid-2018. Additional details can be found in the individual intervention protocol papers in this issue. Conclusions: Through its comprehensive research portfolio, iTech aims to effectively advance HIV prevention and care for youth through technology-based, youth-relevant interventions that maximize adaptability and sustainability. Registered Report Identifier: RR1-10.2196/10365

  • Study logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/8/e10444/; License: Creative Commons Attribution (CC-BY).

    A Multilevel Tailored Web App–Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized...

    Abstract:

    Background: HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston. Objective: The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM’s successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period. Methods: For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment. Results: Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities. Conclusions: The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention’s acceptability, accessibility, availability, and long-term affordability among YMSM. Trial Registration: ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ) Registered Report Identifier: RR1-10.2196/10444

  • Source: FallSensing; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/8/e10304/; License: Licensed by JMIR.

    Multifactorial Screening Tool for Determining Fall Risk in Community-Dwelling Adults Aged 50 Years or Over (FallSensing): Protocol for a Prospective Study

    Abstract:

    Background: Falls are a major health problem among older adults. The risk of falling can be increased by polypharmacy, vision impairment, high blood pressure, environmental home hazards, fear of falling, and changes in the function of musculoskeletal and sensory systems that are associated with aging. Moreover, individuals who experienced previous falls are at higher risk. Nevertheless, falls can be prevented by screening for known risk factors. Objective: The objective of our study was to develop a multifactorial, instrumented, screening tool for fall risk, according to the key risk factors for falls, among Portuguese community-dwelling adults aged 50 years or over and to prospectively validate a risk prediction model for the risk of falling. Methods: This prospective study, following a convenience sample method, will recruit community-dwelling adults aged 50 years or over, who stand and walk independently with or without walking aids in parish councils, physical therapy clinics, senior’s universities, and other facilities in different regions of continental Portugal. The FallSensing screening tool is a technological solution for fall risk screening that includes software, a pressure platform, and 2 inertial sensors. The screening includes questions about demographic and anthropometric data, health and lifestyle behaviors, a detailed explanation about procedures to accomplish 6 functional tests (grip strength, Timed Up and Go, 30 seconds sit to stand, step test, 4-Stage Balance test “modified,” and 10-meter walking speed), 3 questionnaires concerning environmental home hazards, and an activity and participation profile related to mobility and self-efficacy for exercise. Results: The enrollment began in June 2016 and we anticipate study completion by the end of 2018. Conclusions: The FallSensing screening tool is a multifactorial and evidence-based assessment which identifies factors that contribute to fall risk. Establishing a risk prediction model will allow preventive strategies to be implemented, potentially decreasing fall rate. Registered Report Identifier: RR1-10.2196/10304

  • Source: Flickr; Copyright: shoemap; URL: https://www.flickr.com/photos/shoemap/8304301725/in/photolist-pebk2A-dDPHzX; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    Technology-Enhanced Consultations in Diabetes, Cancer, and Heart Failure: Protocol for the Qualitative Analysis of Remote Consultations (QuARC) Project

    Abstract:

    Background: Remote videoconsulting is promoted by policy makers as a way of delivering health care efficiently to an aging population with rising rates of chronic illness. As a radically new service model, it brings operational and interactional challenges in using digital technologies. In-depth research on this dynamic is needed before remote consultations are introduced more widely. Objective: The objective of this study will be to identify and analyze the communication strategies through which remote consultations are accomplished and to guide patients and clinicians to improve the communicative quality of remote consultations. Methods: In previous research, we collected and analyzed two separate datasets of remote consultations in a National Institute for Health Research–funded study of clinics in East London using Skype and a Wellcome Trust–funded study of specialist community heart failure teams in Oxford using Skype or FaceTime. The Qualitative Analysis of Remote Consultations (QuARC) study will combine datasets and undertake detailed interactional microanalysis of up to 40 remote consultations undertaken by senior and junior doctors and nurse specialists, including consultations with adults with diabetes, women who have diabetes during pregnancy, people consulting for postoperative cancer surgery and community-based patients having routine heart failure reviews along with up to 25 comparable face-to-face consultations. Drawing on established techniques (eg, conversation analysis), analysis will examine the contextual features in remote consultations (eg, restricted visual field) combined with close analysis of different modes of communication (eg, speech, gesture, and gaze). Results: Our findings will address the current gap in knowledge about how technology shapes the fine detail of communication in remote consultations. Alongside academic outputs, findings will inform the coproduction of information and guidance about communication strategies to support successful remote consultations. Conclusions: Identifying the communication strategies through which remote consultations are accomplished and producing guidance for patients and clinicians about how to use this kind of technology successfully in consultations is an important and timely goal because roll out of remote consultations is planned across the National Health Service. Registered Report Identifier: RR1-10.2196/10913

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Latest Submissions Open for Peer-Review:

View All Open Peer Review Articles
  • Primary, specialist and allied health services delivered to rural and remote communities and their access by Aboriginal people: Protocol for a mixed methods study

    Date Submitted: Aug 13, 2018

    Open Peer Review Period: Aug 13, 2018 - Aug 27, 2018

    Background: Primary, specialist and allied health services can assist in providing equitable access in rural and remote areas where higher proportions of Aboriginal and Torres Strait Islander people (...

    Background: Primary, specialist and allied health services can assist in providing equitable access in rural and remote areas where higher proportions of Aboriginal and Torres Strait Islander people (Aboriginal Australians) reside to overcome high rates of chronic disease experienced by this population group. Little is currently known about the location and frequency of services and the extent to which providers believe delivery is occurring in a sustained and coordinated manner. Objective: To determine the availability, accessibility and level of coordination of a range of community-based healthcare services to Aboriginal people and identify potential barriers in accessing healthcare services from the perspectives of the health service providers. Methods: This mixed-methods study will take place in three de-identified communities in New South Wales selected for their high population of Aboriginal people and geographical representation of particular location type (coastal, rural and border). The study is designed and conducted in collaboration with communities, Aboriginal Community Controlled Health Services (ACCHSs) and other local health services. Data collection will involve face to face and telephone interviews. Participants will be recruited through snowball sampling and will answer structured, quantitative questions about the availability and accessibility of primary healthcare, specialist medical and allied health services and qualitative questions about accessing services. Quantitative data analysis will determine the frequency and accessibility of specific services across each community. Qualitative data will be analyzed thematically to identify issues relating to availability, accessibility and coordination. The quantitative and qualitative data will then be combined and analyzed using a health ecosystems approach. Results: Twenty eight stakeholder participants across the ACCHSs were identified for recruitment through snowball sampling (N=4 coastal, N=12 rural and N=12 border) for data collection. Conclusions: The study will determine the scope and level of coordination of primary, specialist and allied health services in rural communities with high Aboriginal populations from the perspectives of service providers from those communities. Identification of factors affecting availability, accessibility and coordination of services can assist ways of developing and implementing culturally sensitive service delivery. These findings will inform recommendations for the provision of health services for Aboriginal people in rural and remote settings. The study will also contribute to the broader literature of rural and remote health service provision.

  • Use of dental practices for the identification of adults with undiagnosed type 2 diabetes mellitus or non-diabetic hyperglycaemia; a systematic review protocol.

    Date Submitted: Aug 6, 2018

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

    Background: Diabetes (T2DM) is a growing global burden with T2DM expected to affect more than 590million people by the year 2035. Evidence exists demonstrating that dental settings have been used to t...

    Background: Diabetes (T2DM) is a growing global burden with T2DM expected to affect more than 590million people by the year 2035. Evidence exists demonstrating that dental settings have been used to try and risk assess and identify individuals who may be at high risk of T2DM or who may already unknowingly have the condition. Objective: This protocol aims to outline the methodology which will be undertaken in order to synthesise the literature relating to the use of primary-care, (non-hospital based) dental services for the identification of undiagnosed T2DM or prediabetes - often termed non-diabetic hyperglycaemia (NDH), in adult patients. Methods: This paper outlines the protocol that will be followed to conduct a systematic review and meta-analysis of the available literature. The protocol outlines the aims, objectives, search strategy, data extraction and data management methods, as well as the statistical analysis plan. Prisma-P guidelines were followed in developing the protocol as were elements of the Cochrane handbook. Results: It is anticipated the included studies will demonstrate high levels of heterogeneity resulting in a descriptive synthesis approach to the analysis of results. The descriptive synthesis will be structured around the primary and secondary outcomes of the review. Conclusions: This systematic review will provide evidence on the identification of patients with NDH or T2DM using risk assessment methods, in dental care settings. Additional outcomes include: identification of methodologies utilised within the dental practice for case-finding, establishing recruitment rates within the studies and gaining insight into the opinions of patients and healthcare professionals relating to case-finding. The review will also aim to enhance the understanding of reported barriers to uptake of any such implemented services and reported any identified benefits to utilising dental settings to case find NDH and T2DM. Clinical Trial: Dissemination Following publication of the protocol the review will be registered on PROSPERO. Following completion of the review, results will be published in a suitable peer-reviewed journal.

  • Development & Pilot Evaluation of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community

    Date Submitted: Aug 3, 2018

    Open Peer Review Period: Aug 3, 2018 - Aug 17, 2018

    Background: Across Europe, Canada, Australia, and the United States, prevalence of home mechanical ventilation (HMV) ranges from 6.6 to 12.0 per 100,000. Ventilator-assisted individuals (VAIs) living...

    Background: Across Europe, Canada, Australia, and the United States, prevalence of home mechanical ventilation (HMV) ranges from 6.6 to 12.0 per 100,000. Ventilator-assisted individuals (VAIs) living at home are often vulnerable and highly comorbid requiring complex care. In Canada, most care for VAIs is taken-on by their family, leading to poor health-related quality of life (HrQoL) and exceptional caregiver burden. Therefore, supportive interventions for this caregiver population are needed urgently. Peers are a key source of social support, mitigating caregiving-related declines in health and improving HrQoL by decreasing isolation, buffering stress, and increasing self-efficacy. Yet no peer support programs are tailored to VAI caregivers. Due to the financial, geographic, and time limitations, online support delivery may especially meet VAI family caregiver needs. We have developed a peer mentor training and online peer support program for VAI caregivers that includes information-sharing, peer-to-peer communication, and peer mentorship. Objective: Study Stage 1: a) to evaluate face and content validity of the peer mentor training program; and b) to investigate participant satisfaction. Study Stage 2: To evaluate a) feasibility of participant recruitment and online program delivery; b) acceptability, usability, and satisfactoriness; c) experiences of caregivers and peer mentors with the online peer support program; and d) effect of the online peer support program on caregiver health outcomes Methods: Study Stage 1: We will train 7 caregivers to act as peer mentors for the duration of the online peer support program trial. Peer mentors will complete questionnaires rating the utility of individual training sessions and the training program overall. Study Stage 2: We will recruit 30 caregiver peers for a pilot randomized control trial (RCT) of the 12-week online peer support program using a waitlist control. The online peer support program includes private chat, a public discussion forum, and weekly moderated chats. Caregiver peers will complete health outcome questionnaires (i.e. caregiving impact, mastery, coping, personal gain, positive affect, and depression) before and after the peer support program. Upon completion, caregiver peers (intervention arm only) will complete a program evaluation and will be invited to participate in an interview to provide insight into their experience. Peer mentors will be invited to participate in a virtual focus group to provide insight into their experience as mentors. We will judge feasibility based on the number of recruitment and program delivery goals met. We will use Analysis of Covariance (ANCOVA) to compare health outcomes between intervention and control groups. Thematic analysis will be used to analyze interview and focus group data. Results: Peer mentor training was completed with 5 caregivers in July 2018. Conclusions: To-date, two caregivers have beta-tested the website and the online peer support program trial will commence in September 2018. Clinical Trial: NCT03376711

  • A User Experience Assessment Protocol for Evidence-Based Healthcare Knowledge Integration System

    Date Submitted: Jul 31, 2018

    Open Peer Review Period: Aug 3, 2018 - Aug 17, 2018

    Background: The rapid advancements in healthcare can make it difficult for general physicians and specialists alike to keep their knowledge up to date. In medicine today, there are deficiencies in the...

    Background: The rapid advancements in healthcare can make it difficult for general physicians and specialists alike to keep their knowledge up to date. In medicine today, there are deficiencies in the application of knowledge translation in clinical practice. Some medical procedures are not required and therefore no value is added to the patient’s care. These unnecessary medical procedures increase pressures on the healthcare system’s resources, reduce the quality of care, add to the patient’s stress and expose them to other potential risks. In other instances, a prescribed test or a specific treatment that may not be aligned with the evidence is recommended due to its positive outcomes. Knowledge translation tools and better access to medical recommendations can lead to improvements in physicians decision making processes depending on the patient’s specific clinical situation. These tools can provide the physicians with the available options and promote an efficient professional practice. SEKMED is a technological solution providing access to high-quality evidence, based on just-in-time principles, in the application of medical recommendations for clinical decision-making processes recognized by community members, accreditation bodies (Association des médecins d’urgence du Québec or AMUQ, etc.) and standards bodies (Institut national d’excellence en santé et en services sociaux or INESSS, Choosing Wisely, etc.). Objective: The main objective of the pilot project is to assess the validity and usefulness of the SEKMED platform used within a real working clinical practice, specifically the Centre intégré de santé et des services sociaux de l’Outaouais (CISSSO) in Quebec, Canada. To achieve our main objective, 40 emergency physicians from the Hull Hospital and the Gatineau Hospital will participate in the project as well as 20 patient care unit physicians from the Hull Hospital. Additionally, 10 external students or residents studying family medicine from McGill University will also participate in our study. Methods: The project is divided into four phases: 1) scope, 2) data synthesis, 3) develop and validate the recommendations, and 4) implement, monitor and update the recommendations. These phases will enable us to meet our six specific research objectives. The knowledge gained during each phase will be applied on an iterative and continuous basis to all other phases over a period of two years. Results: This project was funded in April 2018 by the Fonds de soutien à l’innovation en santé et en services sociaux (FSISSS) for a period of 24 months. Ethics approval has been attained and the study is expected to begin June 2018 with preliminary results available in December 2018. Both major city hospitals in the Outaouais region, Quebec, Canada have agreed to participate in the project. Conclusions: If results show preliminary efficacy and usability of the system, a large-scale implementation will be conducted.

  • Structural Transformation to Attain Responsible BIOSciences (STARBIOS2): Protocol for a Horizon 2020 funded European multi-centre project to promote Responsible Research and Innovation

    Date Submitted: Aug 1, 2018

    Open Peer Review Period: Aug 2, 2018 - Aug 16, 2018

    Background: Promoting Responsible Research and Innovation (RRI) is a major strategy of the “Science with and for Society” work programme of the European Union’s Horizon 2020 Framework Programme...

    Background: Promoting Responsible Research and Innovation (RRI) is a major strategy of the “Science with and for Society” work programme of the European Union’s Horizon 2020 Framework Programme for Research and Innovation. RRI aims to achieve a better alignment of research and innovation with the values, needs, and expectations of society. The RRI strategy includes the “keys” of public engagement, open access, gender, ethics, and science education. The STARBIOS2 project promotes RRI in six European research institutions and universities from Bulgaria, Germany, Italy, Slovenia, Poland, and the United Kingdom, working in partnership with a further six institutions from Brazil, Denmark, Italy, South Africa, Sweden, and the United States. Objective: The project has three specific objectives: 1) to attain RRI structural change in six European institutions through the implementation of action plans and to develop action plans for three non-European institutions active in the field of biosciences; 2) to use the implementation of action plans as a learning process with a view to developing a set of guidelines on the implementation of RRI; 3) to develop a sustainable model for RRI in biosciences. Methods: The project consists of inter-related research and implementation designed to achieve the aforementioned specific objectives. The project is organised into six core work packages and five supporting work packages. The core work packages deal with the implementation of institutional action plans in five European institutions based on the structural change activation model. The supporting work packages include technical assistance; learning process on RRI-oriented structural change; monitoring and assessment; communication and dissemination; and project management. Results: The project has received funding from Horizon 2020 and runs for four years from May 2016 to April 2020. As of June 2018, the initial planning phase has been completed. The participating institutions have developed and approved action plans, and commenced their implementation. An observation tool has been launched by the Technical Assistance Team to collect information from the implementation of action plans and the Evaluation & Assessment team has started to monitor the advancement of the project. As part of the communication and dissemination strategy, a project website, a Facebook page, and a Twitter account have been launched and are updated periodically. The International Scientific Advisory Committee has been formed to advise on the reporting and dissemination of the project’s results. Conclusions: In the short term, we anticipate that the project will have a significant impact on the organisational processes and structures improving the uptake of RRI in the participating institutions. In the medium term, we expect to make RRI-oriented organisational change scalable across Europe through the development of guidelines on the implementation of RRI and a model for RRI in the biosciences. In the long term, we expect that the project will help to increase the ability of research institutions to make discoveries and innovations in better alignment with societal needs and values.

  • eMums plus: A pragmatic randomised controlled trial evaluating the effectiveness of an online nurse-moderated program for new mothers with depression and parenting problems

    Date Submitted: Aug 1, 2018

    Open Peer Review Period: Aug 1, 2018 - Aug 15, 2018

    Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childho...

    Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing sub-threshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving respectively, despite these problems commonly being comorbid. Online group-based nurse-led interventions delivered by mobile phone ‘apps’ have the potential to be a cost-effective method of providing large numbers of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. Objective: This paper describes the protocol for a pragmatic randomised controlled trial to determine whether a 4-month online group-based nurse-led intervention delivered when infants were 2-6 months, reduced levels of maternal depressive symptoms and improved the quality of maternal caregiving when infants were aged 8-12 months. The intervention provided specific support for both problems with mood and problems with caregiving. It was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. Methods: The trial aimed to recruit and randomise 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (pre-intervention), 8, and 12 months. The primary outcomes were level of maternal depressive symptoms and quality of maternal caregiving assessed when infants were aged 12 months. Results: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Conclusions: In the past many mothers participated in nurse-led face-to-face groups postnatally. However, mothers groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered online by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in routine service practice is that if it is found to be effective it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN 12616001732471

Advertisement