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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:

  • ATN CARES logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/12/e10777/; License: Licensed by JMIR.

    Development of an Electronic Data Collection System to Support a Large-Scale HIV Behavioral Intervention Trial: Protocol for an Electronic Data Collection...

    Abstract:

    Background: Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances for electronic data capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants, deliver intervention directly to participants’ mobile devices, monitor staff activity, and facilitate near real-time decision making during study implementation. Objective: This paper presents the infrastructure of an EDC system designed to support a multisite HIV biobehavioral intervention trial in Los Angeles and New Orleans: the Adolescent Medicine Trials Network “Comprehensive Adolescent Research & Engagement Studies” (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. Methods: The CARES EDC system is designed to monitor and document multiple study functions, including, screening, recruitment, retention, intervention delivery, and outcome assessment. Text messaging (short message service, SMS) and nearly all data collection are supported by the EDC system. The system functions on mobile phones, tablets, and Web browsers. Results: ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. Besides data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality, and field staff supervision. The system is supporting both incoming and outgoing text messages (SMS) and offers high-level data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using EDC systems are addressed through programming updates and training on how to improve data quality. Conclusions: There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided whether the flexibility provided by the development of a study-specific, in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, text messaging (SMS) interventions, and case management and a separate Web-based platform to support an online peer support intervention. Decisions need to be made regarding the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering text messages (SMS) to study participants’ mobile phones. EDC data security protocols should be developed under guidance from security experts and with formative consulting with the target study population as to their perceptions and needs. International Registered Report Identifier (IRRID): PRR1-10.2196/10777

  • Source: Unsplash; Copyright: rawpixel; URL: https://unsplash.com/photos/ipBUwm7FTEA; License: Licensed by the authors.

    Predicting Prediabetes Through Facebook Postings: Protocol for a Mixed-Methods Study

    Abstract:

    Background: The field of infodemiology uses health care trends found in public networks, such as social media, to track and quantify the spread of disease. Type 2 diabetes is on the rise worldwide, and social media may be useful in identifying prediabetes through behavior exhibited through social media platforms such as Facebook and thus in designing and administering early interventions and containing further progression of the disease. Objective: This pilot study is designed to investigate the social media behavior of individuals with prediabetes, before and after diagnosis. Pre- and postdiagnosis Facebook content (posts) of such individuals will be used to create a taxonomy of prediabetes indicators and to identify themes and factors associated with an actual diagnosis of prediabetes. Methods: This is a single-center exploratory retrospective study that examines 20 adults with prediabetes. The investigators will code Facebook posts 3 months before through 3 months after prediabetes diagnosis. Data will be analyzed using both qualitative content analysis methodology as well as quantitative methodology to characterize participants and compare their posts pre- and postdiagnosis. Results: The project was funded for 2015-2018, and enrollment will be completed by the end of 2018. Data coding is currently under way and the first results are expected to be submitted for publication in 2019. Results will include both quantitative and qualitative data about participants and the similarities and differences between coded social media posts. Conclusions: This pilot study is the first step in creating a taxonomy of social media indicators for prediabetes. Such a taxonomy would provide a tool for researchers and health care professionals to use social media postings for identifying those at greater risk of having prediabetes. International Registered Report Identifier (IRRID): DERR1-10.2196/10720

  • Source: Unsplash; Copyright: rawpixel; URL: https://unsplash.com/photos/mqpMdf1MeRE; License: Licensed by JMIR.

    Facilitating Web-Based Collaboration in Evidence Synthesis (TaskExchange): Development and Analysis

    Abstract:

    Background: The conduct and publication of scientific research are increasingly open and collaborative. There is growing interest in Web-based platforms that can effectively enable global, multidisciplinary scientific teams and foster networks of scientists in areas of shared research interest. Designed to facilitate Web-based collaboration in research evidence synthesis, TaskExchange highlights the potential of these kinds of platforms. Objective: This paper describes the development, growth, and future of TaskExchange, a Web-based platform facilitating collaboration in research evidence synthesis. Methods: The original purpose of TaskExchange was to create a platform that connected people who needed help with their Cochrane systematic reviews (rigorous syntheses of health research) with people who had the time and expertise to help. The scope of TaskExchange has now been expanded to include other evidence synthesis tasks, including guideline development. The development of TaskExchange was initially undertaken in 5 agile development phases with substantial user engagement. In each phase, software was iteratively deployed as it was developed and tested, enabling close cycles of development and refinement. Results: TaskExchange enables users to browse and search tasks and members by keyword or nested filters, post and respond to tasks, sign up to notification emails, and acknowledge the work of TaskExchange members. The pilot platform has been open access since August 2016, has over 2300 members, and has hosted more than 630 tasks, covering a wide range of research synthesis-related tasks. Response rates are consistently over 75%, and user feedback has been positive. Conclusions: TaskExchange demonstrates the potential for new technologies to support Web-based collaboration in health research. Development of a relatively simple platform for peer-to-peer exchange has provided opportunities for systematic reviewers to get their reviews completed more quickly and provides an effective pathway for people to join the global health evidence community.

  • Sleepio app. Source: The Authors; Copyright: Sleepio; URL: http://www.researchprotocols.org/2018/12/e11324/; License: Licensed by JMIR.

    Supported Web-Based Guided Self-Help for Insomnia for Young People Attending Child and Adolescent Mental Health Services: Protocol for a Feasibility Assessment

    Abstract:

    Background: Sleep disturbance in adolescents is common, with up to one-third reporting significant symptoms of insomnia. Research with adults has demonstrated that Web-based cognitive behavioral therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking, and we know little about whether CBTi would have similar effects on this younger population. Objective: This paper summarizes the protocol of a study to assess the feasibility of adding supported Web-based CBTi to the usual care of young people aged 14-17 years attending specialist Child and Adolescent Mental Health Services (CAMHS). Methods: This is an open trial where we will recruit young people (N=50) aged 14-17 years attending specialist CAMHS with primary or comorbid symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6-session, Web-based CBTi self-help program for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction, and cognitive techniques that participants will be helped to apply through brief, weekly telephone support calls. Questionnaires and interviews will be completed at baseline and postintervention (8-10 weeks) and will assess sleep, symptoms of depression and anxiety, and acceptability of Sleepio and telephone support. Results: Recruitment started in May 2018 and continued until the end of October 2018. Conclusions: This study will provide preliminary evidence about whether supported Web-based CBTi is acceptable to young people with mental health problems and about the postintervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomized trial to determine the effectiveness of Sleepio should be undertaken. International Registered Report Identifier (IRRID): DRR1-10.2196/11324

  • Dose distribution in para-aortic radiotherapy trial. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e11256/; License: Licensed by JMIR.

    Benefits of Elective Para-Aortic Radiotherapy for pN1 Prostate Cancer Using Arc Therapy (Intensity-Modulated or Volumetric Modulated Arc Therapy): Protocol...

    Abstract:

    Background: In patients with prostate cancer (PCa) with histopathologically proven pelvic lymph node (LN) metastasis (pN1) after extended pelvic lymph node dissection (ePLND), multimodality treatment consisting of treatment of the primary tumor and whole pelvic radiotherapy (WPRT) combined with androgen deprivation therapy (ADT) offers promising results, leading to better cause-specific survival rates compared with ADT alone. However, in case more than one pelvic LN is invaded by the tumor, approximately 40% of the patients relapse biochemically and clinically. Clinical relapse is present in the para-aortic LNs (M1a disease) in up to 77% of the relapsing cases. Objective: We hypothesize that, based on the evidence that positive LNs represent the door to hematogenous dissemination, elective para-aortic irradiation will reduce the development of both retroperitoneal nodal (M1a) and distant metastasis (M1b or M1c disease), postpone the need for palliative ADT, and prolong the time to castration-refractory disease. Methods: To test this hypothesis, we will conduct a prospective, nonrandomized phase II trial to study the efficacy of additional elective para-aortic radiotherapy (PART) in pN1 patients compared with those who were historically treated with adjuvant WPRT alone. We aim to include 137 patients with PCa and presence of pN1 disease after ePLND. With this number of patients, an improvement of 15% in the 5-year clinical relapse-free survival can be detected with a power of 80%. Results: Recruitment of patients for this trial started in 2017 and will be completed approximately by March 2020. Conclusions: This is the first phase II trial to investigate the benefits of an elective PART in patients with PCa. The results of this trial will potentially serve as a sound base for a later randomized phase III trial. All participants are given a PART information sheet and required to give written informed consent. Results are expected to be published in a peer-reviewed journal. Trial Registration: ClinicalTrials.gov NCT03079323; https://clinicaltrials.gov/ct2/show/NCT03079323 (Archived by WebCite at http://www.webcitation.org/73ELimv1d) International Registered Report Identifier (IRRID): PRR1-10.2196/11256

  • Source: The Authors; Copyright: MMPN Piyasena; URL: http://www.researchprotocols.org/2018/12/e10900/; License: Licensed by JMIR.

    Development and Validation of a Diabetic Retinopathy Screening Modality Using a Hand-Held Nonmydriatic Digital Retinal Camera by Physician Graders at a...

    Abstract:

    Background: Visual impairment and blindness from diabetic retinopathy (DR), which can be reduced by early screening and treatment, is an emerging public health concern in low-income and middle-income countries (LMICs) owing to the increasing prevalence of diabetes mellitus (DM). However, no systematic screening exists in most LMIC settings. The Western province of Sri Lanka has the highest prevalence of DM (18.6%) in the country. A situational analysis identified a marked gap in DR screening (DRS) and treatment services uptake in this region; only opportunistic screening is practiced currently. Objective: The aim of this protocol is to describe the methods of development and validation of a DRS intervention using a hand-held nonmydriatic digital camera by physician graders in a non-ophthalmological setting at a tertiary-level medical clinic to propose a valid and feasible modality to improve uptake. Methods: DRS modality was developed after assessing barriers and identifying the most appropriate personnel, methods, and location for screening services, following formative research work. The validation will be conducted in a public sector tertiary care center in the Western province of Sri Lanka. The selected physicians will be trained on capturing and grading images according to a valid locally adopted protocol. Two physicians rated high on training will screen a sample of 506 people with DM at a medical clinic. They will use nonmydriatic and mydriatic 2-field imaging strategy. The validity of the proposed screening procedure will be assessed and compared with the mydriatic indirect biomicroscopic examination by a senior retinologist. Results: The validity of screening by physician graders will be analyzed and the sensitivity, specificity, and predictive values (with 95% CIs) calculated by the dilation status and for each grader. The diagnostic accuracy at each level of severity of DR will be assessed to define the most appropriate referable criteria. Data is currently being collected. Conclusions: The outcome of this study will be useful for the detection of a defined level of DR at non-ophthalmological setting to filter the people with DM before referral to an eye clinic. This will be helpful to improve the uptake and identify risk groups in advance to prevent sight-threatening DR. Furthermore, evidence from this study will be useful for the implementation of a DRS program in this region and in similar communities. International Registered Report Identifier (IRRID): PRR1-10.2196/10900

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/12/e10215/; License: Creative Commons Attribution (CC-BY).

    Establishing Digital Biomarkers for Occupational Health Assessment in Commercial Salmon Fishermen: Protocol for a Mixed-Methods Study

    Abstract:

    Background: Commercial salmon fishing in Alaska is one of the most dangerous occupations in the United States. Between 1992 and 2008, the average annual industry mortality rate was 128 deaths per 100,000 workers, and despite an increase in industry regulations, there has not been a significant decrease in mortality rate since 2000. Unpredictable fishing openings and fierce competition for limited resources result in periods of intense sleep deprivation and physical strain during the short commercial salmon season in Alaska. Objective: We hypothesize that the combined effect of sleep deprivation, intense physical workload, and significant short-term chronic stress may be deleterious to health in both the short- and long-term among commercial salmon drift gillnet fishermen in Alaska. The objective of this protocol is to determine the feasibility of the study design to test this hypothesis. Methods: The study design uses mixed methods and includes biometric monitoring consisting of heart rate variability, respiration, and movement data collected via a personal, wearable biometric device. Additional methods include observational data on activity, including duration and quality of sleep, weather, catch, and financial gain, as well as the collection of salivary cortisol. As such, the study will provide a holistic assessment of individual stress on multiple simultaneous timescales: immediately and continuously through the personal wearable biometric device, on the minute-hour level through the multiple daily collections of salivary cortisol, and by the hour-day through the use of participant and environment observational data. Results: Data collection was initiated in July 2017 and will extend through August 2019. Initial data collection has indicated that the methods outlined in this protocol are feasible and allow for effective collection of qualitative and quantitative data related to the psychological and physiological impact of Alaska commercial salmon fishing. Conclusions: We anticipate that the use of a biometric device will be crucial in establishing measures of stress and physical activity within a population and environment uniquely challenged by physical isolation, strong weather patterns, and the potential for significant financial gain by fishermen. The potential exists for individuals engaged long-term in the fishing industry, through repeated and extended exposure to periods of intense sleep deprivation and chronic stress, to be at increased risk of cardiovascular disease. International Registered Report Identifier (IRRID): DERR1-10.2196/10215

  • LowSalt4Life logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e11282/; License: Creative Commons Attribution (CC-BY).

    A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial...

    Abstract:

    Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. Trial Registration: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) International Registered Report Identifier (IRRID): PRR1-10.2196/11282

  • Family physician consulting a patient in distress. Source: iStock by Getty Images; Copyright: monkeybusinessimages; URL: https://www.istockphoto.com/gb/photo/doctor-discussing-test-results-with-senior-male-patient-gm469214862-61432660; License: Licensed by the authors.

    An Electronic Clinical Decision Support System for the Assessment and Management of Suicidality in Primary Care: Protocol for a Mixed-Methods Study

    Abstract:

    Background: Suicide is a global public health concern, but it is preventable. Increased contact with primary care before the suicide or attempted suicide raises opportunities for intervention and prevention. However, suicide assessment and management are areas that many general practitioners (GPs) find particularly challenging. Previous research has indicated significant variability in how GPs understand, operationalize, and assess suicide risk, which subsequently has an impact on clinical decision making. Clinical decision support systems (CDSS) have been widely implemented across different health care settings, including primary care to support practitioners in clinical decision making. A CDSS may reduce inconsistencies in the identification, assessment, and management of suicide risk by GPs by guiding them through the consultation and generating a risk assessment plan that can be shared with a service user or with specialized mental health services. Objective: Our aim is to co-develop and test with end users (eg, GPs, primary care attendees, mental health professionals) an electronic clinical decision support system (e-CDSS) to support GPs in the identification, assessment, and management of suicidality in primary care. Methods: Ours is an ongoing embedded mixed-methods study with four phases: (1) qualitative interviews with GPs to explore their views on the content, format, and use of the e-CDSS, as well as consultation with two service-user advisory groups (people aged ≤25 and people aged ≥25) to inform the content of the e-CDSS including phrasing of items and clarity; (2) participatory co-production workshops with GPs, service users, and clinical experts in suicidality to determine the content and format of the e-CDDS; gain consensus of the relevance of items; establish content validity and identify pathways to implementation, using the Consolidated Framework for Implementation Research; (3) building the e-CDSS so that it guides the GP through a consultation; and (4) usability testing of the e-CDSS with GPs and service users in one primary care practice involving a nonlive and a live stage. Results: The study was funded for four years, to take place between 2015 and 2019, and is currently completing phase 4 data collection. The first results are expected to be submitted for publication in June 2019. The findings will enable us to evaluate the feasibility, acceptability, and usability of a suicide-specific, electronic, guided decision support system in primary care. Conclusions: This study will be the first to explore the feasibility, acceptability, and usability of an electronic, guided decision support system for use in primary care consultations for the improved assessment and management of suicidality. International Registered Report Identifier (IRRID): RR1-10.2196/11135

  • The HEMAIR logo. Source: Image created by the Authors; Copyright: Nathan Smischney; URL: http://www.researchprotocols.org/2018/11/e11101/; License: Creative Commons Attribution (CC-BY).

    Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study

    Abstract:

    Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation occurs, the current practice is largely unknown. This is relevant, as advances in airway equipment (ie, video laryngoscopes) have become more prevalent, leading to possible improvement of care delivered during this process. In addition to new devices, a greater emphasis on airway plans and choices in sedation have evolved, although the influence on patient morbidity and mortality is largely unknown. Objective: This study aims to derive and validate prediction models for immediate airway and hemodynamic complications of intensive care unit intubations. Methods: A multicenter, observational, prospective study of adult critically ill patients admitted to both medical and surgical intensive care units (ICUs) was conducted. Participating ICU sites were located throughout eight health and human services regions of the United States for which endotracheal intubation was needed. A steering committee composed of both anesthesia and pulmonary critical care physicians proposed a core set of data variables. These variables were incorporated into a data collection form to be used within the multiple, participating ICUs across the United States during the time of intubation. The data collection form consisted of two basic components, focusing on airway management and hemodynamic management. The form was generated using RedCap and distributed to the participating centers. Quality checks on the dataset were performed several times with each center, such that they arrived at less than 10% missing values for each data variable; the checks were subsequently entered into a database. Results: The study is currently undergoing data analysis. Results are expected in November 2018 with publication to follow thereafter. The study protocol has not yet undergone peer review by a funding body. Conclusions: The overall goal of this multicenter prospective study is to develop a scoring system for peri-intubation, hemodynamic, and airway-related complications so we can stratify those patients at greatest risk for decompensation as a result of these complications. This will allow critical care physicians to be better prepared in addressing these occurrences and will allow them to improve the quality of care delivered to the critically ill. Trial Registration: ClinicalTrials.gov NCT02508948; https://clinicaltrials.gov/ct2/show/NCT02508948 (Archived by WebCite at http://www.webcitation.org/73Oj6cTFu) International Registered Report Identifier (IRRID): RR1-10.2196/11101

  • The So-Lo-Mo app. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/12/e12464/; License: Creative Commons Attribution (CC-BY).

    Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). Methods: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. Results: Of 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. Conclusions: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). International Registered Report Identifier (IRRID): PRR1-10.2196/12464

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/12/e12339; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic...

    Abstract:

    Background: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. Objective: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. Methods: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. Results: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. Conclusions: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. Trial Registration: UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) International Registered Report Identifier (IRRID): DERR1-10.2196/12339

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    Open Peer Review Period: Dec 11, 2018 - Dec 25, 2018

    Background: Children with medical complexity are a group of children with multiple chronic conditions and functional limitations that represent the highest health care utilization and often require a...

    Background: Children with medical complexity are a group of children with multiple chronic conditions and functional limitations that represent the highest health care utilization and often require a substantial number of home and community-based services (HCBS). In many states, HCBS are offered to target populations through 1915(c) Medicaid waivers. To date, there has not been standard methods or approaches to evaluate or compare 1915 (c) waivers across states for children. Objective: The purpose of this analysis was to develop a systematic and reproducible approach to evaluate 1915(c) Medicaid waivers for overall coverage for children. Methods: Data elements were extracted from Medicaid 1915(c) approved waivers applications for all included waivers targeting any pediatric age range through October 31, 2018. Normalization criteria were developed and an aggregate overall coverage score calculated for each waiver. Results: 142 waivers across 45 states were included in this analysis. Through this process, it was recognized that existing adult HCBS taxonomy may not always be applicable for child and family-based service provision. Even though there was uniformity in the Medicaid applications, there was great heterogeneity how waiver eligibility, transition plans, and wait lists were defined. Conclusions: We present methods and analyses for the first study to our knowledge to systematically evaluate 1915 (c) Medicaid waivers targeting CMC that can be replicated without the threat of missing data. Clinical Trial: n/a non-human subjects research; policy analysis

  • Type of paper: Research protocol Title: Stimulation of Nucleotide oligomerisation domain and toll like-receptors 2 to enhance the effect of BCG immunisation on prevention of Mycobacterium tuberculosis infection

    Date Submitted: Dec 6, 2018

    Open Peer Review Period: Dec 10, 2018 - Dec 24, 2018

    Background: BCG immunisation has been associated with a reduction in Mycobacterium (M.) tuberculosis infection. BCG immunisation has been shown to enhance innate immunity via an effect on Nucleotide o...

    Background: BCG immunisation has been associated with a reduction in Mycobacterium (M.) tuberculosis infection. BCG immunisation has been shown to enhance innate immunity via an effect on Nucleotide oligomerisation domain (NOD) receptors. The reduction of Mycobacterium tuberculosis infection by BCG can be explained by an enhancing effect on innate immunity. Hypotheses: • BCG immunisation can prevent infection with M. tuberculosis • Prevention of infection occurs via stimulation of NOD-2 and toll like receptors (TLR)- 2. • The effect of BCG immunisation on prevention of infection with M. tuberculosis can be enhanced by giving stimulators of NOD-2 and TLR-2. Objective: Objective are to establish: 1. To confirm the validity of a mouse model of a partial infection with M. tuberculosis. 2. To investigate whether BCG immunisation can reduce infection with M. tuberculosis. 3. To investigate whether stimulators of NOD-2, TLR-2 or dectin-1 receptors can enhance an effect of BCG on reduction of infection with M. tuberculosis. 4. To investigate the influence of T-suppressor cells on a reduced reactivity in the gamma interferon release assay results in M. tuberculosis exposed BCG vaccinated mice. 5. To investigate whether a reduction of infection with M. tuberculosis in BCG immunised mice and in mice injected with enhancers of innate immunity is associated with a significant increase in markers of enhancement of innate immunity like H3K4 trimethylation of monocyte DNA and increase in Ly6Chigh and CD11b positive monocytes in uninfected mice. 6. To investigate whether a reduction of infection with M. tuberculosis is associated with an increased intracellular expression of TNF and Interferon gamma mRNA levels in monocytes in uninfected mice. 7. To establish whether inhibition of epigenetic programming can reduce the effect of BCG immunisation and stimulators of innate immunity on M. tuberculosis infection and markers of activation of innate immunity. Methods: Experimental protocols to confirm hypotheses To detect the influence of immunisation on infection rates the ultra-low dose (ULD) infection model is used: Groups of female adult C57BL/6 mice are exposed to ultra-low dose M. tuberculosis aerosol. Mice vaccinated with BCG and exposed after 6 weeks to ultra- low dose of M. tuberculosis and mice not vaccinated are compared in infection rate by cultures of lung homogenates and interferon gamma release assay. If a reduced infection rate by BCG immunisation is confirmed the experiment is repeated by giving BCG combined simultaneously or in time sequence with the enhancers of innate immunity murabutide or beta-glycan. In addition the influence of murabutide or beta-glycan alone on infection rates is investigated. To quantify the contribution of innate immunity levels of TNF and IFN gamma expression and histone H3 K4me3 trimethylation and concentrations of monocytes with features of activation of innate immunity as defined by the Ly6Chigh as well as CD11b positive phenotype in immunized versus unimmunized infected and uninfected mice in the various immunisation protocols is compared and the experiments repeated with prior application of the inhibitors of epigenetic programming of innate immunity histone methyltransferase inhibitor 5’-deoxy-5’-methylthio-adenosine and histone acetyl transferase inhibitor epigallocatechin-3-gallate. The influence of BCG on innate immunity is further corroborated by a prospective observational study in human infants. Results: Evidence supporting the hypothesis: • The first experiments using derivatives of MDP to enhance early immunity in the C57BL/6 mouse strain (7 weeks old mice) used 300 micrograms per mouse of oil-associated 6-0-mycoloyl-N-acetylmuramyl-L-alanyl-D-isoglutamine (mycol-MDP) 50/50 mixed with Freund’s incomplete adjuvant suspended with 0.9% sodium chloride solution with 0.2% Tween aiming at a final oil concentration of 3% and given intravenously. Comparison of colony forming unit (CFU) count in the lungs 3 weeks after aerosol challenge with Mycobacterium bovis of groups (n=5) between groups receiving mycol-MDP in oil emulsion (see above) versus controls (n=5) receiving only oil emulsion showed a significantly lower CFU count of 94.5 x106 (SD 22.0) in cases versus controls with 204.0 X 106 (SD 77.6) [20]. It is important to note that after elimination of T-cells in this model (by irradiation and thymectomy) a reduction of CFU in lungs of mice treated with mycol-MDP persisted albeit without statistical significance, which was possibly related to the small number of animals used. This result confirmed the findings of a previous study of the same group in the mouse strain C3H/He. • The BCG primed increased TNF release by monocytes has been shown to be related to effects of epigenetic programming in form of stimulation of trimethylation of histone H3 at lysine 4 (H3K4). Establishment of innate immunity in monocytes could hereby be inhibited by use of inhibitors of epigenetic programming. Evidence against the hypothesis: • The most important alternative hypothesis, which could be advanced to explain the apparently reduced infection rate on gamma interferon release assay testing in BCG immunised humans or mice is clonal imprinting (previously termed “original antigenic sin” phenomenon) where previous exposure to an antigen (in this case BCG) leads to reinforcement of the immune reaction to this antigen on exposure of the immune-system to a similar antigen (M. tuberculosis) containing this previous antigen (in this case BCG) rather than a reaction to the new antigen (M. tuberculosis specific epitopes) not contained in the antigen mixture of the previous exposure. This process has been found to be dependent on the action of the cytokine IL-10. IL-10 is hereby produced by non-antigen specific T-suppressor cells [23] thus postulated to reduce interferon gamma release in M. tuberculosis exposed individuals in the gamma interferon release assays if there was a previous exposure to BCG. This alternative hypothesis can be tested by elimination of T-suppressor cells. • The protective effect of BCG immunisation against infection with M. tuberculosis is reduced in low income countries but its effect against other infections, which is more consistent with enhancement of innate immunity, is considerable. This is more supportive of the hypothesis that the reduction of infection with M. tuberculosis is also due to T-effector cells, which can be influenced by malnutrition and helminth infection triggered regulatory T-cell activation and not due to effects of BCG on innate immunity. The conclusion would therefore be that innate immunity can actually not be enhanced by antigens similar to BCG derived substances, which can stimulate NOD-2 or TLR-2. Conclusions: Potential impact of confirmation of hypotheses Demonstration of a reduction of M. tuberculosis infection by enhancement of innate immunity could show a new approach to improving vaccine efficacy against this pathogen. Clinical Trial: Not applicable

  • Protocol for a randomised experiment of smartphone-based adaptive feedback support on healthcare workers' learning gains in paediatric emergency care training

    Date Submitted: Dec 5, 2018

    Open Peer Review Period: Dec 10, 2018 - Dec 24, 2018

    Background: While smartphone-based clinical training to support emergency care training is more affordable than traditional avenues of training, it is still in its infancy, remains poorly implemented,...

    Background: While smartphone-based clinical training to support emergency care training is more affordable than traditional avenues of training, it is still in its infancy, remains poorly implemented, and current implementations tend to be invariant to the evolving learning needs of the intended users. This randomised experiment aims to assess the effectiveness of offering adaptive feedback versus standard feedback, on mobile smartphone-based platforms. Objective: The aim of this randomised experiment is to investigate if adaptive individualised feedback is superior to standardised feedback, on mobile smart-phone based emergency paediatric care training. We hypothesise that patients randomised to adaptive feedback arm will have a significant improvement in learning gains than those randomised to standardised feedback. Methods: The experiment is aimed at healthcare workers who provide bedside paediatric care in low-income settings. We will use data captured through use of an Android based smartphone application that will have been downloaded to personal phones belonging to the study participants. The data captured will include level of feedback provided to participants as they are learning through the mobile application, and performance data from attempts made at skill mastery assessments on emergency paediatric care delivery. The primary endpoint will be the first two complete rounds of learning within the application from which the ‘learning gain’ will be computed. To minimise bias, participants will be assigned to experimental or control group by a within-application random generator, with this process being concealed to both the study participants and the investigators until the primary endpoint is reached. ANOVA will be used to analyse the differences between the feedback groups. Results: Results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Central University Research Ethics Committee (CUREC) of the University of Oxford together with Scientific and Ethics Review Unit (SERU) of Kenya Medical Research Institute (KEMRI). Conclusions: This study will be used as a platform to explore effectiveness of adaptive feedback in smartphone-based training for healthcare workers in a low-income setting to improve health outcomes in neonatal emergency care. This aspect of medical education is a largely unexplored topic in this context. The risk of performance bias across arms is moderate given the active ingredient of the intervention (i.e. knowledge) is a latent trait that is difficult to comprehensively control for in a real-world setting. However, the influence of any resulting bias in its ability to alter results will be assessed within the study using alternative methods such as qualitative interviews.

  • Motivational Interviewing to reduce drug use and HIV incidence among high PrEP priority YMSM in relationships (Project PARTNER): A randomized controlled trial protocol

    Date Submitted: Dec 3, 2018

    Open Peer Review Period: Dec 7, 2018 - Dec 21, 2018

    Background: Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the U.S. , and, among young MSM aged 20-29, as many as 79-84% of new infections occur bet...

    Background: Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the U.S. , and, among young MSM aged 20-29, as many as 79-84% of new infections occur between primary partners. Contributing to HIV risk, young MSM use drugs at comparatively high rates. To date, no interventions have been developed which specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change. Objective: This study seeks to evaluate the efficacy of PARTNER (Prevention and Risk: Treatment with a New Emphasis on Relationships), a motivational interviewing -based intervention which integrates video-based communication skills training to address drug use and HIV prevention among partnered YMSM, including PrEP uptake and adherence; and to evaluate potential moderators or mediators of intervention efforts. Secondarily, we will explore the potential to develop and validate a novel biomarker for PrEP adherence by analyzing PrEP drug levels in fingernails. Methods: This study utilizes a randomized controlled trial design to compare the 4-session PARTNER intervention to an attention-matched psychoeducation control arm with follow-up assessments conducted at 3-, 6-, 9- and 12-months post-baseline. The study will recruit and enroll 240 partnered YMSM between the ages 18-29. Participants will be HIV-negative, and will report recent (past 30-day) drug use and either condomless anal sex (CAS) with a casual partner; a non-monogamous primary partner (regardless of HIV status); or a sero-discordant primary partner (regardless of sexual agreement). Self-report drug use and sexual behavior data are gathered via Timeline Follow-back interview. Biological samples are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing) and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay). Results: Project PARTNER has been open to enrollment since February, 2018. Enrollment is ongoing. Conclusions: Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (e.g., dyadic functioning and sexual agreements) are meaningfully related to substance use and HIV transmission risk for partnered men. Results pertaining to the efficacy of the proposed intervention, as well as the identification of putative moderators and mediators, will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. Clinical Trial: ClinicalTrials.gov; NCT03396367

  • Impact of perinatal different intrauterine environments on child growth and development in the first six months of life: Profile of IVAPSA Study.

    Date Submitted: Dec 3, 2018

    Open Peer Review Period: Dec 5, 2018 - Dec 19, 2018

    Background: Several studies have shown that perinatal events may impact on the health outcomes in children and adults. Objective: Considering the potential for interventions during pregnancy and first...

    Background: Several studies have shown that perinatal events may impact on the health outcomes in children and adults. Objective: Considering the potential for interventions during pregnancy and first years of life, the IVAPSA study aim to amplify the knowledge upon the impact of different intrauterine environments on infant growth and development. Methods: The recruitment 24 to 48 hours after delivery involved mothers and their newborns in two public hospitals from Porto Alegre, Brazil, from December 2011 to January 2016. The pairs were allocated into five groups: DM - participant with clinical diagnosis of diabetes, considering any disease classification; SAH - participant with clinical diagnosis of hypertensive disease during pregnancy; MS - participant who smoked at any moment of gestation; SGA - participant with newborn small for gestational age; and CTL - participant without the clinical characteristics previously mentioned. Several protocols were applied in interviews that were conducted at postpartum, 7 and 15 days and at 1, 3 and 6 months of the infant's life. For this work, we analyzed only data collected during postpartum interview. The statistical analyses were performed using Pearson chi-square test, Mann Whitney test, or Kruskal Wallis test with Dunn post-hoc. The significance level was set at 5%. Results: Of the 485 eligible mother-newborn pairs, only 400 agreed to participate. As expected, newborns from SGA group had significantly low birth weight, height and head circumference (P<.001). This group also had the highest percentage of primiparous women in comparison to other groups (P=.005) with exception of CTL. Mothers from SAH group had the highest median age, as well as a higher percentage of cesareans. Additionally, these mothers presented greater gestational weight gain. Conclusions: In the present study, we can highlight the main strengths, the planning and structuring of a birth follow-up, considering the scenario of demographic and epidemiological transition in Brazil. Therefore, this follow-up study with its innovative design can bring new insights about causal mechanisms involved in the health and illness in life course.

  • A protocol involving a new light-emitting, fabric-based device (the Phosistos protocol) versus the conventional protocol for photodynamic therapy of actinic keratosis − a randomized, controlled, multicentre, intra-individual, phase II non-inferiority study.

    Date Submitted: Nov 29, 2018

    Open Peer Review Period: Dec 5, 2018 - Dec 19, 2018

    Background: Actinic keratosis (AK) is a common precancerous skin lesion caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cel...

    Background: Actinic keratosis (AK) is a common precancerous skin lesion caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. In order to prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery and photodynamic therapy (PDT). Objective: The aim of this study is to assess the non-inferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device, the Phosistos protocol (P-PDT), compared to the conventional protocol (C-PDT) in the treatment of AK. Methods: In this randomized, controlled, multicentre, intra-individual, phase II non-inferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm2) for 2h30 so that a light dose of 12 J/cm2 is achieved. In the control area (C-PDT area), a 37 J/cm2 red light irradiation is performed 3 hours after incubation with MAL. Recurrent AK at three months are retreated. The primary endpoint is the lesion complete response rate at three months. Secondary endpoints include pain scores at one day, local tolerance at seven days, lesion complete response rate at six months, cosmetic outcome at three and six months, and patient-reported quality of life and satisfaction throughout the study. Forty-five patients need to be recruited. Results: Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing and statistical results will be available in the first half of 2019. Conclusions: In case of non-inferiority in efficacy and superiority in tolerability of P-PDT compared to C-PDT, P-PDT could become the treatment of choice for AK. Clinical Trial: The study was registered in ClinicalTrials.gov under identifier NCT03076892 (date of registration: March 10, 2017).

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