The Karma system is currently undergoing maintenance (Monday, January 29, 2018).
The maintenance period has been extended to 8PM EST.
Karma Credits will not be available for redeeming during maintenance.
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
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 2016: 5.175).
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"!
Right click to copy or hit: ctrl+c (cmd+c on mac)
Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation may occur, the current practice is largely unknown. Th...
Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation may occur, the current practice is largely unknown. This is relevant as advances in airway equipment, i.e., 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. Thus, through a multi-center prospective study, our aim was to derive and validate prediction models for immediate airway and hemodynamic complications of intensive care unit intubations. Objective: The overall goal of this multi-center prospective study is to arrive at a prediction model for both immediate airway and hemodynamic complications thus allowing critical care physicians to be better prepared to address these occurrences and improve the quality of care delivered to the critically ill. Methods: A multi-center, observational, prospective study of adult critically ill patients admitted to both medical and surgical intensive care units at participating sites throughout 8 health and human services regions of the country for which endotracheal intubation was needed was conducted. A steering committee composed of both anesthesia and pulmonary critical care physicians proposed a core set of data variables as a data collection form to be used within the multiple intensive care units across the country during the time of intubation. The data collection form consisted of two basic components, focusing 1- on airway management and 2- on hemodynamic management. The form was generated using RedCap and distributed to the participating centers. Quality checks on the dataset was performed several times from each center to arrive at less than 10% missing values for each data variable and subsequently entered into a database. The primary outcomes will focus on both derivation and validation of airway and hemodynamic models to predict immediate airway and hemodynamic complications of intensive care unit intubations. Results: With these procedures and requirements in place, the rights and welfare of subjects were not adversely affected by study participation or the waiver of consent/authorization. This multi-center, prospective trial will be among the first to include a large diverse patient population from across the United States with a large sample size. The potential benefits would include deriving and validating prediction models for immediate severe complications regarding airway and hemodynamic management surrounding intubations among the critically ill. Conclusions: With this information, it is our hope that the clinician will have a tool to predict which patients will become unstable during this procedure so as to adjust treatment plans allowing improved quality of care delivered during this procedure. This prospective observational trial is even more important as post-intubation hypotension/hemodynamic derangement is noted by some to occur at a fairly high rate leading to possibly increased risk of mortality. Clinical Trial: Clinicaltrials.gov identifier NCT02508948 (07/21/2015)
Background: Young men have different mental health needs to young women, who make up the primary audience of digital mental health interventions. An app (MindMax) incorporating sport (Australian Footb...
Background: Young men have different mental health needs to young women, who make up the primary audience of digital mental health interventions. An app (MindMax) incorporating sport (Australian Football League; AFL), videogames, and gamification was developed in an effort to address this issue. Objective: This protocol outlines the research and development process of MindMax. Methods: These include: 1) six participatory design workshops with young people aged 16 to 35 years; 2) 15 user experience testing interviews at three separate time points to iteratively assess and improve the app; and 3) a naturalistic trial, tracking users across multiple time points to evaluate the app. Results: Preliminary results suggest a preference for an action-based approach and a strong preference for a personalised experience. A naturalistic longitudinal trial (baseline N=441) concluded in May 2018. Conclusions: In basing itself strongly within the AFL and videogaming subcultures, MindMax aims to tackle mental health help-seeking barriers for men, and to provide psychoeducation on strategies to increase mental wellbeing. A successful implementation would indicate that generalising this approach to other traditional sporting codes and even competitive videogaming leagues (esports) would be fruitful.
Background: New technologies invariably open up possibilities towards new forms of action, of interaction, and of knowledge acquirement, something extremely relevant in the health education field. How...
Background: New technologies invariably open up possibilities towards new forms of action, of interaction, and of knowledge acquirement, something extremely relevant in the health education field. However, a protocol is needed for new digital means towards the use of an immersive interactive interface, both ludic and educational, regarding oral health with a preventive focus on health maintenance and a healthy development of the child, by means of Augmented Reality, activated by the user interaction with the projection. Objective: Development of an immersive virtual environment protocol using Augmented Reality for the improvement of the quality of teaching, in the fields of science and youth odontological health, making available modern content and interfaces, in order to point out paths for the evolution of technological resources in teaching and learning; i.e., a concrete tool for the universalization of knowledge and digital inclusion. Methods: A qualitative study will be conducted in order to define a research protocol for the development of a serious game that uses augmented reality techniques in order to disseminate oral health knowledge among children at school age, and its training as to the correct execution of teeth brushing techniques. During the first phase of the study, a template analysis will be conducted to identify barriers and facilitators in each scenario. Then, during the second phase, the computational process, the gestural, graphic elements and cognitive processes involved in the development of the research protocol of the interactive panel will be analyzed and delineated. In a posterior phase, after the implementation of the system, an analysis of the product efficacy will be conducted, by means of usability tests conducted with the target audience. Results: This article presents the development protocol of the instructional immersive interactive environment, using projection and computational resources. Conclusions: It is hoped that these protocols contribute to the prevention of buccal problems afflicting the population, by means of the diffusion of scientific knowledge of the aforementioned fields in the school environment, and that its replication is done by the students themselves, assuming the role of multipliers of this knowledge with the community.
Background: Community based health and social resources can help individuals with complex health and social needs. However, there is often a discontinuation of patient care between primary care practi...
Background: Community based health and social resources can help individuals with complex health and social needs. However, there is often a discontinuation of patient care between primary care practices and community resources due to: a lack of physician or patient awareness of available resources; the presence of social barriers; the paucity of means to facilitate patients’ trajectory along the continuum of care; and more broadly, to the difficulties implementing organizational changes in primary care practices already busy providing health care services. Navigation services – where a person is tasked with helping connect patients to community resources – can strengthen continuity of care for patients. The implementation and study of the navigators’ impact is complex and warrants further investigation. Objective: Assess whether the ARC Model is feasible, including its potential to achieve its intended outcomes, and the viability of the evaluation approach. Methods: Describe the protocol of a single arm, prospective, explanatory mixed methods, pre-post design feasibility study, focusing on primary care practice settings with vulnerable populations. Participants include primary care providers, and patients. Results: Enrollment is closed with 82 patients. Navigation services have ended for 69 patients. Conclusions: Multilayered complex issues contribute to a high risk of failing to sustainably implement navigation services, thwarting randomized control trials’ effectiveness at assessing their impact. Undertaking a feasibility study from a conceptually clear and methodologically solid protocol will inform on the acceptability, ease of implementation, quality of integration, practicality and adaptation needs prior to initiating a randomized control trial. Clinical Trial: ClinicalTrials.gov, NCT03105635. Registered 10 April 2017
Background: New biomedical prevention interventions make the control or elimination of some blood -borne viruses (BBVs) and sexually transmissible infections (STIs) increasingly feasible. In response,...
Background: New biomedical prevention interventions make the control or elimination of some blood -borne viruses (BBVs) and sexually transmissible infections (STIs) increasingly feasible. In response, the World Health Organization and governments around the world have established elimination targets and associated timelines. Objective: This paper describes ACCESS (Australian Collaboration for Coordinated Enhanced Sentinel Surveillance), a national surveillance network designed to monitor public health and evaluate the impact of strategies aimed at controlling BBVs and STIs in Australia. Methods: ACCESS is a sentinel surveillance system comprising health services and pathology laboratories in each of the eight Australian jurisdictions. Sites that provide significant testing or management of BBVs and/or STIs or see populations with particular risks for these infections (‘priority populations’) are included in the network. ACCESS is based on regular and automated extraction of de-identified patient data using specialised software called GRHANITE™, which creates a unique and anonymous identifier from individual patient details. This identifier allows anonymous linkage between and within participating sites, creating a national cohort that allows the evaluation of clinical and public health interventions and related research. Results: As of March 2018, 104 health services (sexual health clinics, general practice clinics, drug and alcohol services, community-led testing services, and hospital outpatient clinics) and 17 pathology laboratories (private and public) were participating in ACCESS. Between 2009 and 2017, ACCESS captured data from 1,171,658 individual patients who attended a participating health service at least once, comprising a total of 7,992,241 consultations. Conclusions: ACCESS is a unique system with the ability to track efforts to control STIs and BBVs – including through the calculation of powerful epidemiological indicators – by identifying response gaps and facilitating the evaluation of programs and interventions. By anonymously linking patients between and within services and over time, ACCESS has exciting potential as a research and evaluation platform.
Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems in patients and professionals. In a context of increasing healthcare burdens, introducin...
Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems in patients and professionals. In a context of increasing healthcare burdens, introducing innovative tools based on mobile Health Apps can have a significant effect on healthcare systems. Objective: To evaluate the effectiveness of the Listeo+ mobile Health App as a tool for improving adherence to preoperative recommendations in major ambulatory surgery (MAS) versus standard of care (SoC). Methods: A multicenter, randomized, open-label clinical trial that compares SoC to the additional use of Listeo+, a specific mobile Health App for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, and those in the intervention group will additionally use the Listeo+ mobile Health App. There will be a competitive recruitment of 790 patients during six months in four hospitals of Andalusia (Spain) that belong to the National Health System. The main efficacy variable is adherence to preoperative recommendations. Secondary variables include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Results: The technological development of Listeo+ and the integration and interoperability of the information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the four participating centers. After an intermediate analysis performed six months after the start of the recruitment phase, it is expected that the phases of data collection, data cleaning, and final data analysis will be completed in June 2018. Conclusions: Progress in the integration and interoperability of information systems represents a major step forward in the field of mobile health (mHealth).