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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.
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).
Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!
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Background: The rate of viral suppression among persons 13 years of age and older residing in 37 states and the District of Columbia in 2014 was 58%, leaving considerable opportunity for onward transm...
Background: The rate of viral suppression among persons 13 years of age and older residing in 37 states and the District of Columbia in 2014 was 58%, leaving considerable opportunity for onward transmission and contributing to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the US. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the "Thrive with Me" (TWM) intervention for men who have sex with men (MSM) living with HIV. Critical components of the protocol are presented. Objective: To rigorously test the efficacy of the TWM to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City. Methods: A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of TWM and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective randomized controlled trial (RCT) and follow them for 17 months. Men in the TWM experimental intervention arm will have access to TWM for 5 months. TWM has three primary components: 1) a private social networking feature; 2) tailored HIV and ART adherence information; and 3) medication reminders, self-monitoring, and reflection. Gamification components include badges and levelling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via e-mail and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and five, eleven, and seventeen months post-enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence. Results: Participant recruitment for the RCT began in October 2016 and the data collection period is anticipated to end in the Fall of 2019. Conclusions: The efficacy trial of TWM will help to fill gaps in understanding about the utility of multi-component technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the TWM trial to inform best practices for conducting technology-based interventions that incorporate social media features. Clinical Trial: ClinicalTrials.gov (NCT02704208); University of Minnesota Institutional Review Board (1504S69721)
Background: Alcohol use among university students is common and those who drink often choose to drink heavily (i.e., 4 or more drinks per session for women or 5 or more for men). Web-Based Interventio...
Background: Alcohol use among university students is common and those who drink often choose to drink heavily (i.e., 4 or more drinks per session for women or 5 or more for men). Web-Based Interventions (WBIs), in which students complete assessments and receive personalized feedback about their alcohol use, and Ecological Momentary Interventions (EMIs), which use mobile devices as a method of delivering intervention information, are two methods that have had some success in reducing alcohol use among university students. Objective: The aim of the current study is to investigate the efficacy of a combined WBI and EMI intervention to reduce alcohol use among university students. Methods: The study is a three-arm RCT. Participants will be randomised into either a WBI + EMI condition, a WBI-only condition, or an assessment only control. Our sample will consist of first-year university students, recruited through five residential colleges at the University of Otago, New Zealand. All participants will complete an online questionnaire at baseline (i.e., before Orientation Week); those in the WBI and WBI + EMI conditions will immediately receive feedback (i.e., the WBI) based on their answers, whereas participants in the control group will receive no feedback. In addition, participants randomised in the WBI + EMI, but not those in the WBI-only or control groups, will receive eight Orientation Week (two per-day on nights with orientation events) and six academic year EMIs (fortnightly). Participants in all conditions will complete brief surveys at the send of the first and second semester and report their weekend alcohol use fortnightly throughout each semester via Ecological Momentary Assessments (EMAs). Results: The primary hypothesis is that participants in the WBI + EMI condition will consume significantly fewer drinks during weekends in their first year at university compared to a WBI only and control group. Secondary hypotheses are that, when compared with the WBI alone and control group, the WBI + EMI condition will report consuming fewer drinks during Orientation Week, report experiencing fewer negative alcohol-related consequences after first semester, and report lower AUDIT-C scores following their first semester. Conclusions: N/A Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000015246.
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Background Attention biases are subconscious processes that tend to result in individuals having increased attention for threatening or stimuli with high salience. These biases have been posited to b...
Background Attention biases are subconscious processes that tend to result in individuals having increased attention for threatening or stimuli with high salience. These biases have been posited to be involved in the psychopathologies of several psychiatric disorders. Technological advances have transformed how such interventions are being delivered. Gamification technologies are increasingly being used for bias modification, as it could help increase motivation to train and make these tasks more engaging. While there are published research on gamification and attention bias, there remains several gaps in knowledge. Objectives The primary objective of the review is thus to identify attention bias modification games that have been published in the literature and to synthesise the current evidence for such interventions and to identify, if possible, the rationale for gamification. The secondary objective is to determine if gamified attention or cognitive bias modification influences secondary outcomes measures, as such anxiety levels or severity of depressive symptoms. Methods To achieve the objective of this review, a systematic review will be undertaken. For the studies that are identified, they will be reviewed by independent assessors and screened against our predefined inclusion and exclusion criteria. The Cochrane risk of bias tool will be used for assessment of the risk of biases in randomised trials that have been identified. The evidence will be synthesized by means of a qualitative synthesis. Results We expect that the review will be completed 12 months from the publication of this protocol. Conclusions This review is pertinent as it helps to provide an overview of the evidence base for gamified attention bias interventions. The findings from the current review will help in the future conceptualisation of gamified attention bias interventions.
Background: Adolescents and young adults (AYA) with cancer face significant challenges during the course of medical treatment and recovery from illness. Many struggle with long-term complications in p...
Background: Adolescents and young adults (AYA) with cancer face significant challenges during the course of medical treatment and recovery from illness. Many struggle with long-term complications in physical, psychosocial, economic and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of applications (apps) on smartphones and tablets. In order to create a successful mHealth intervention for AYAs, youth input and feedback is essential. The process of co-creation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for AYA with cancer, TeleKræftværket. Objective: The objective of this article is to describe the protocol for the qualitative and quantitative testing and analysis of the Kræftværket app, a prototype app designed via co-creation for AYAs with cancer to support and improve health-related quality of life (HRQoL). Methods: The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 AYAs age 15-29 selected for equal representation amongst age group, and treatment status. Patients will be allowed to utilize the app over the course of six weeks, and will complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. In addition, participant focus group interviews will be conducted according to a semi-structured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample size of 50 AYAs age 15-29 selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. Results: Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. Conclusions: It is the hope that Kræftværket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting AYA oncology patients in the digital world.
Background: New methods for in- and outpatient data collection and for improvning outpatient compliance after discharge are called for. Interactive and mobile technologies i.e. smartphone applications...
Background: New methods for in- and outpatient data collection and for improvning outpatient compliance after discharge are called for. Interactive and mobile technologies i.e. smartphone applications (apps) have shown promising results, e.g. helping unwell people by offering support and resources. Screening the current condition, including comorbidity, is a vital part of psychiatric care. Comorbid conditions, especially in emergency evaluation, are often missed leading to inaccurate diagnosis and treatment. Also in child and adolescent psychiatric emergency settings, little is known regarding treatment satisfaction. One way of improving diagnostic accuracy and to increase knowledge regarding treatment satisfaction is to use a structured diagnostic process as well as adding a tool to assess consumer satisfaction. Digitalized screening and follow-up has the advantage of making the administration and scoring easier and less time consuming leading to higher response rate. To address the described problems we decided to create a smartphone application: Blå Appen. Objective: The aim of this paper is to describe the development of Blå Appen and to describe the two planned research studies to evaluate the application. Methods: : Blå Appen was developed through 7 different steps: (1) Identifying the need for quick and easy information gathering; (2) identifying desired information and choosing adequate screening questionnaires (3) examining the feasibility in acute psychiatric environment – pilot study; (4) getting organizational acceptance – feasibility study; (5) App construction; (6) Workshop with adolescents - what do the patients think; (7) evaluation - research study 1 & 2. Results: (1) We decided to create a smartphone application based on our previous work on interactive voice response. (2) Eleven validated screening questionnaires were chosen with regard to frequent comorbid states in child & adolescent psychiatry. (3) A pilot study was performed (n=16) indicating good acceptability. In the next step (4) we performed a feasibility study concluding that the method we planned adds value for our patients and no existing solutions were found on the market. The IT department gave their final approval for funding in May 2015. (5) The work resulted in a public procurement. (6) We performed a workshop indicating good feasibility. (7) Two studies will be performed, one in inpatients identifying comorbid conditions and the other to assess outpatient compliance and treatment outcome. Conclusions: A technically advanced and easy-to-use web based mobile phone application corresponding to the unit’s needs was developed and two studies to evaluate its usefulness were planned.
Background: In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of dental caries. Recent research has reported on the effectiveness of dental home...
Background: In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of dental caries. Recent research has reported on the effectiveness of dental home visits (DHVs) in preventing caries development of caries in young children. DHVs is described as an ongoing relationship between the dentist and his/her patients, providing all aspects of preventive oral health care programme in the presence of the parents at home. The aim of this study is to evaluate the cost effectiveness of DHVs and oral health information in the form of educational leaflets (ELs) in preventing new caries development in young children compared to those receiving only ELs over a period of two years. The cost-effectiveness analysis (CEA) is widely used to inform decision makers about the value of new health programme and interventions. Study methods: This is a collaborative project with the Oral Health Division (OHD) of the Ministry of Health Malaysia. The OHD will provide access to a sub-sample from the National Oral Health of Preschoolers Survey (NOHPS) which was carried out in year 2015. The population of interest is children aged 5 and 6 year-olds from kindergartens in the Selangor state in Malaysia. The study adopted a societal perspective for CEA, all types of resources that are of value to society will be included in analyzing the costs; such as cost to the patient, cost to the provider/institution and indirect costs because of the loss of productivity. Discussion: The amount of young children in Malaysia who have been referred to the hospital children’s dentistry service for severe caries is disturbing. The cost of dental treatment in young children is high due to the severity of the caries which require an aggressive treatment, and the need for general anaesthesia or sedation. This study will provide information on the cost and effectiveness of DHVs in caries prevention of young children in Malaysia.