Maintenance Note

On Friday, August 31, 2018 at 12:00 pm Eastern Time, JMIR will be completing a server migration to improve site stability and user experience. We expect to be back online Friday, August 31, 2018 at 5:00 pm Eastern Time. Should any problems arise our technical team will be using the weekend to resolve them, and users will be able to access our site by Sunday, September 2, 2018 at 1:00pm Eastern Time.

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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:

  • RODEO project logo. Source: JMIR Research Protocols; Copyright: Renuka S Bindraban; URL: http://www.researchprotocols.org/; License: Creative Commons Attribution (CC-BY).

    A Multicenter Before-After Study on Reducing Unnecessary Diagnostics by Changing the Attitude of Caregivers: Protocol for the RODEO Project

    Abstract:

    Background: Appropriate use of diagnostic laboratory tests is challenging, and estimates of 20% for overutilization and 45% for underutilization have been reported. Introducing effective and sustainable solutions to stimulate optimal use of laboratory testing in clinical practice is a challenge. A recent pilot study from our group, focusing on increasing the awareness about appropriate laboratory testing with the aim of changing the mindset of health care workers, has shown promising results. In this project, we aim to extend this multistep intervention to the internal medicine departments of 4 large Dutch hospitals. We aim to reduce unnecessary laboratory testing by 5%. Objective: Our primary objective is to determine the effect of our intervention on diagnostic laboratory test order volume. Our secondary objectives are to determine the effect of our intervention on laboratory expenditure and order volumes, expenditures for other diagnostic modalities, and clinical patient outcomes. We will also analyze the barriers and facilitators for deimplementation of unnecessary laboratory testing. Methods: The main interventions of this before-after study will be an intensified supervision of residents by experienced physicians regarding test ordering, creating awareness through education and monthly feedback on ordering patterns, and changes in (computerized) order entry systems. Results: At the time of publication of this protocol, the project is in the phase of data collection. We expect to present data on reduction early in the fourth quarter of 2018. Conclusions: In this project, we aim to reduce the unnecessary diagnostic testing in the internal medicine departments of 4 teaching hospitals. Although the main interventions will be similar, each clinic is given the opportunity to focus on the specific facets of the interventions as deemed useful according to the local situation. If effective, the study provides a framework for a nationwide initiative for reducing inappropriate laboratory testing. Registered Report Identifier: RR1-10.2106/10473

  • Source: Flickr.com; Copyright: Ed Yourdon; URL: https://www.flickr.com/photos/yourdon/4695962052; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    A Mobile App (iBeni) With a Neuropsychological Basis for Cognitive Stimulation for Elderly Adults: Pilot and Validation Study

    Abstract:

    Background: Cognitive impairment is considered one of the most feared chronic conditions among the older adult population since its incidence is approximately twice more frequent than that of dementia. In Mexico, no studies or reports of older adults using technology for cognitive interventions have been published, given that institutions usually frame cognitive stimulation tasks in paper and pencil (ie, in the traditional manner). Objective: The objective of this study was to create and analyze the effect, viability, and impact of a mobile app for cognitive stimulation implemented among a group of elderly adults (over 60 years of age) from the state of Hidalgo in Mexico. Methods: This study was a nonprobabilistic pilot trial using convenience sampling. An intervention was implemented among a group of 22 older adults between 60 and 80 years of age over 12 weeks. Half of the older adults were stimulated with the mobile app (experimental group) and the other half followed the traditional paper and pencil training (control group). Assessments with the Mini-Mental State Examination (MMSE) and the Neuropsi, a neuropsychological test validated in Mexico, were done before and after both cognitive stimulations. Results: According to the analyzed data, 6/11 (55%) participants from the experimental group obtained better results in their cognitive skills, and 5 (45%) of the adults maintained their score, given that the participants were able to execute the exercises repetitively. Meanwhile, for the control group, only 3/11 (27%) participants obtained better results in the postevaluation. Significant values for results of the MMSE were obtained in the postevaluation for the experimental group compared to the control group, while results did not show significant differences in the Neuropsi. Regarding the validation of the app, all the participants evaluated its pertinence positively. Conclusions: The intervention data show that the experimental group obtained better results in the postevaluation given that the participants were able to execute the exercises repetitively. The control group could not accomplish this since they had to respond on the manual and no further attempts were provided. However, both groups increased their score in the neuropsychological evaluations. This suggests that a longer and more frequent intervention is required. Registered Report Identifier: RR1-10.2196/9603

  • The Climate Schools Plus logo. Source: Image created by Authors; Copyright: Netfront Pty Ltd / The Authors; URL: http://www.researchprotocols.org/2018/8/e10849/; License: Licensed by JMIR.

    Internet-Based Universal Prevention for Students and Parents to Prevent Alcohol and Cannabis Use Among Adolescents: Protocol for the Randomized Controlled...

    Abstract:

    Background: Early initiation of alcohol and cannabis use markedly increases the risk of harms associated with use, including the development of substance use and mental health disorders. To interrupt this trajectory, effective prevention during the adolescent period is critical. Despite evidence showing that parents can play a critical role in delaying substance use initiation, the majority of prevention programs focus on adolescents only. Accordingly, the Climate Schools Plus (CSP) program was developed to address this gap. Objective: This paper outlines the protocol for a cluster randomized controlled trial (RCT) of the CSP program, a novel internet-based program for parents and students to prevent adolescent substance use and related harms. The CSP program builds on the success of the Climate Schools student programs, with the addition of a newly developed parenting component, which allows parents to access the internet-based content to equip them with knowledge and skills to help prevent substance use in their adolescents. Methods: A cluster RCT is being conducted with year 8 students (aged 12-14 years) and their parents from 12 Australian secondary schools between 2018 and 2020. Using blocked randomization, schools are assigned to one of the two groups to receive either the CSP program (intervention) or health education as usual (control). The primary outcomes of the trial will be any student alcohol use (≥1 standard alcoholic drink/s) and any student drinking to excess (≥5 standard alcoholic drinks). Secondary outcomes will include alcohol- and cannabis-related knowledge, alcohol use-related harms, frequency of alcohol consumption, frequency of drinking to excess, student cannabis use, parents’ self-efficacy to stop their children using alcohol, parental supply of alcohol, and parent-adolescent communication. All students and their parents will complete assessments on three occasions—baseline and 12 and 24 months postbaseline. In addition, students and parents in the intervention group will be asked to complete program evaluations on two occasions—immediately following the year 8 program and immediately following the year 9 program. Results: Analyses will be conducted using multilevel, mixed-effects models within an intention-to-treat framework. It is expected that students in the intervention group will have less uptake and excessive use of alcohol compared with the students in the control group. Conclusions: This study will provide the first evaluation of a combined internet-based program for students and their parents to prevent alcohol and cannabis use. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000153213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374178 (Archived by WebCite at http://www.webcitation.org/71E0prqfQ) Registered Report Identifier: RR1-10.2196/10849

  • 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

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  • 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.

  • A prospective study on the need of gated (GAT) radiotherapy in left sided breast cancer patients treated at the Technical University Munich (TUM) The GATTUM Trial: Study Protocol

    Date Submitted: Aug 13, 2018

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

    Background: Deep inspiration breathhold (DIBH) it is the most widely used technique for heart sparing. Nonetheless, treatment preparation, patient coaching and treatment planning/ delivery can be more...

    Background: Deep inspiration breathhold (DIBH) it is the most widely used technique for heart sparing. Nonetheless, treatment preparation, patient coaching and treatment planning/ delivery can be more time consuming than conventional techniques. Objective: The aim of our study is to find predictive measurements that will allow an estimation of the heart dose reduction by DIBH and thus allow a precise selection of these patients. Methods: The GATTUM trial is a single institution, prospective pilot study. 150 breast cancer patients who will undergo radiotherapy at the university hospital ‘Klinikum rechts der Isar’ will be included in the study. All patients will undergo breathing triggered radiation planning with a CT during free breathing (FB) and a CT during deep inspiration breath hold (DIBH). Patients without cardiac risk factors with heart Dmean ≥ 3 Gy and for patients with cardiac risk factors with heart Dmean ≥ 2Gy are recommended to undergo radiation therapy in DIBH. The primary endpoint of the study is to identify measurements that will predict the heart dose reduction in DIBH. Secondary endpoints include quality of life and cosmesis. Results: The measurements that we aim to find by this study are to be performed on a planning CT or a diagnostic CT performed beforehand; easy to perform by each staff member; correlated with clinical data (such as breast size; heart and lung morphometry; heart and lung comorbidities) and correlated with the a 3D CRT tangential field “standard” dose distribution. Conclusions: This study could help to improve the knowledge about the necessity of respiratory-gated radiotherapy. We expect that evidence-based indications regarding optimization-criteria for radiation planning of breast cancer patients can be determined for the first time. Clinical Trial: The study was retrospectively registered on the 23rd of May 2018 on clinicaltrials.gov with the following ID: NCT03534570. https://clinicaltrials.gov/ct2/show/NCT03534570 The study is currently recruiting patients. The first patient was recruited on 15th October 2015.

  • The development of a nurse-led self-management support intervention for kidney transplant recipients using intervention mapping: the ZENN-study

    Date Submitted: Aug 7, 2018

    Open Peer Review Period: Aug 9, 2018 - Aug 23, 2018

    Background: Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and healthcare costs while improving quality of life However, ther...

    Background: Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and healthcare costs while improving quality of life However, there are few effective interventions aimed at providing self-management support after kidney transplantation. Objective: The objective of this study was to systematically development a nurse-led, self-management (support) intervention for kidney transplant recipients. Methods: The Intervention Mapping protocol was used to develop an intervention which incorporates recipients’ and nurses’ needs, theories, and evidence-based methods. The needs of recipients and nurses were assessed by reviewing the literature, conducting focus groups, individual interviews, and observations (step 1). Based on the needs assessment, self-regulation theory and the ‘5As’ model, change objectives were formulated (step 2). Evidence-based methods to achieve these objectives were selected and subsequently translated into practical implementation strategies (step 3). Program materials and protocols were developed accordingly (step 4). Implementation was scheduled for 2015 –2017 (step 5). The last step of Intervention Mapping, evaluation of the intervention falls outside the scope of this paper (step 6). Results: The intervention was developed to optimize self-management (support) after kidney transplantation and targeted both the kidney transplant recipients as well as the nurse practitioners who provided the intervention. The intervention was clustered into four 15 minute sessions based on an intervention protocol that were added to the standard medical care in the outpatient clinic. Nurses received a training syllabus and were trained in communication techniques based on the principles of Solution-Focused Brief Therapy. Patients were encouraged to assess self-management challenges using the Self-Management Web and subsequently develop specific goals, action plans and pursuit skills to solve these challenges. Conclusions: The Intervention Mapping protocol provided an advantageous framework to systematically develop a self-management intervention in which nurses and patients’ needs, evidence-based methods and theories were integrated.

  • Protocol of a pilot & feasibility Randomized Controlled Trial comparing written versus pictorial Asthma Action Plans to improve asthma management and health outcomes among children and adolescents.

    Date Submitted: Aug 9, 2018

    Open Peer Review Period: Aug 9, 2018 - Aug 23, 2018

    Background: Asthma is an important focal point for health-focused research as ineffective symptom management and control can lead to significant morbidity and mortality. Current treatment guidelines f...

    Background: Asthma is an important focal point for health-focused research as ineffective symptom management and control can lead to significant morbidity and mortality. Current treatment guidelines for asthma recommend the use of a written asthma action plan (WAAP) to include individualized instruction for daily care and medication use. However, WAAPs are typically written at a 7th to 9th grade reading level, which can be a barrier to patients understanding their treatment, having confidence in using a WAAP, and engaging in asthma education during clinic visits. Objective: Utilizing a feasibility and pilot Randomized Controlled Trial (RCT) design, the objective of the Take Action for Asthma Control (TAAC) study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in contrast to a standard WAAP, and assess the feasibility and acceptability of the AAP intervention and study procedures. The study has three primary aims: (1) estimate the effect sizes of PAAPs compared to WAAPs, (2) evaluate feasibility and acceptability from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. Methods: This feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6-months in duration. At baseline, participants are randomly assigned to receive a PAAP or WAAP, which is generated for them and review with them by their asthma physician. Study procedures take place over four separate time points, including a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point date are collected related to the main outcomes of AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up 60 participants (ages 8-17 years) is being recruited. Feasibility and acceptability data are collected via one-to-one qualitative interviews with providers involved in the study, and a sub-group of families that participate in the study. Results: Recruitment for the current phase of the study began in May 2017. It is anticipated that recruitment will continue through May 2018. Full results will immediately follow follow-up data collection. Conclusions: An asthma action plan is an individualized, evidence-based strategy for patient education and asthma management. The standard WAAP, however, is dense and may be a barrier for families with lower literacy levels. Due to these concerns, many families are not prescribed a WAAP despite national guidelines encouraging its use. Moreover, pictorial asthma action plans (PAAPs) may be an acceptable and feasible alternative for these families. Clinical Trial: NCT03187119

  • The process of developing an internet-based CBT self-help program for Arabic-speaking immigrants in Sweden

    Date Submitted: Aug 8, 2018

    Open Peer Review Period: Aug 9, 2018 - Aug 23, 2018

    Background: Recent years have seen an increase in Arabic-speaking immigrants in Sweden and other European countries with research showing this group to suffer from elevated levels of various forms of...

    Background: Recent years have seen an increase in Arabic-speaking immigrants in Sweden and other European countries with research showing this group to suffer from elevated levels of various forms of psychological distress. There is a lack of treatment options for immigrants with mild to moderate mental health problems, with barriers including lack of accessible services and concerns that problems will not be understood by health care providers. Objective: This article describes the process of developing a transdiagnostic internet-based CBT self-help program in Arabic for mild to moderate symptoms of psychological distress. Methods: The iterative development process, including feedback from 105 pilot users as well as two focus groups, is described. Results: Overall, the modules were rated as acceptable by the pilot users. Feedback from the two focus groups was overall positive with regards to the content and structure of the program but also included suggestions for improving the Arabic translation as well as the usability of the material. Conclusions: An internet-based self-help program that is deemed acceptable by an Arabic-speaking audience can be successfully developed.

  • Genetic determinants of ototoxicity during and after childhood cancer treatment: design of PanCareLIFE studies

    Date Submitted: Aug 8, 2018

    Open Peer Review Period: Aug 9, 2018 - Aug 23, 2018

    Background: Survival rates after childhood cancer now reach nearly 80% in developed countries. However, the treatment leading to this improved survival can cause serious adverse effects that have life...

    Background: Survival rates after childhood cancer now reach nearly 80% in developed countries. However, the treatment leading to this improved survival can cause serious adverse effects that have life-long negative impacts on survivor’s quality of life. Hearing impairment is a common adverse effect in children treated with cisplatin-based chemotherapy or cranial radiotherapy. Ototoxicity can extend from high-tone hearing impairment to involvement of speech frequencies. Hearing impairment can impede speech and language, and neurocognitive development. Although treatment related risk factors for hearing loss following childhood cancer treatment have been identified, the individual variability in toxicity of adverse effects after similar treatment between childhood cancer patients suggests a role for genetic susceptibility. Currently, twelve candidate gene approach studies have been performed to identify polymorphisms predisposing to platinum-induced ototoxicity in children being treated for cancer. However, most studies were underpowered, lacked replication, and results were inconsistent. Objective: We describe the design of PCL work packages (WP) 4b and 5 addressing the genetic susceptibility of platinum-induced ototoxicity. Methods: As a part of the PanCareLIFE study within the framework of the PanCare consortium, we address genetic susceptibility of treatment-induced ototoxicity during and after childhood cancer treatment in a large European cohort. Results: This study includes 1124 survivors treated with cisplatin, carboplatin or cranial radiotherapy for childhood cancer, resulting in the largest clinical European cohort assembled for this late-effect to date. Nested within the larger cohort is a homogenous, unique, well-defined cohort of 598 cisplatin-treated childhood cancer patients, not confounded by cranial radiotherapy. Conclusions: The PanCareLIFE initiative provides, for the first time, a unique opportunity to both confirm already identified determinants for hearing impairment during childhood cancer using a candidate gene approach and to set up the first international genome-wide association study of cisplatin-induced direct ototoxicity in childhood cancer patients to identify novel allelic variants. Results will be validated in an independent replication cohort. Genetic factors, identified as part of this pan-European project PanCareLIFE, may contribute to more accurate prediction models that can be incorporated in future clinical trials of platinum-based therapies for cancer, and may help with the development of prevention strategies.

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