JMIR Research Protocols
Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
JMIR Research Protocols (ISSN 1929-0748) publishes 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 new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2015: 4.532)
JMIR Res Protoc 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 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)
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Latest Submissions Open for Peer-Review:View All Open Peer Review Articles
MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A comparison of clinical outcomes before and after the MISSION clinic.
Date Submitted: Oct 24, 2016
Open Peer Review Period: Oct 24, 2016 - Nov 7, 2016
COPD affects over 1 million people in the UK and 1 person dies from COPD every 20 minutes. The cost to people with COPD and the NHS is huge – more than 24 million working days a lost a year and the...
COPD affects over 1 million people in the UK and 1 person dies from COPD every 20 minutes. The cost to people with COPD and the NHS is huge – more than 24 million working days a lost a year and the annual spend on COPD is £810 million and £930 million a year. Portsmouth in particular has a higher rate than the national average of deaths related to smoking and COPD. MISSION COPD is a new and novel way of identifying patients with COPD who are at risk of exacerbations and hospitals admissions as well as those who have not been formally diagnosed yet remain at risk. MISSION COPD project will then hold multi disciplinary carousel style clinics to rapidly assess the patients’ COPD and related comorbidities, and enhance patient knowledge and skills for self management. The accomapnying research protocol describes a mixed methods study which captures quantitative and qualitative outcomes to accompany this programme of Quality Improvement through delivery of Novel Care Models.
Dance for adults with fibromyalgia, what do we know about it? Protocol for a scoping review
Date Submitted: Oct 23, 2016
Open Peer Review Period: Oct 23, 2016 - Nov 6, 2016
Background: Fibromyalgia is a chronic disorder characterized by widespread muscular tenderness, pain, fatigue and cognitive difficulties. Non-pharmacological treatment options, such as physical activi...
Background: Fibromyalgia is a chronic disorder characterized by widespread muscular tenderness, pain, fatigue and cognitive difficulties. Non-pharmacological treatment options, such as physical activity, are important for people with fibromyalgia. There are strong recommendations to support engagement in physical activity for symptom management among adults with fibromyalgia. Dance is a mode of physical activity that may allow individuals with fibromyalgia to improve their physical function, health, and well-being. Dance has the potential to promote improved pain processing while simultaneously providing the health and social benefits of engaging in physical activity that contribute to symptom management. However, we are unaware of current evidence on dance as a non-pharmacological/physical activity intervention for adults with fibromyalgia. Objective: the aims of the study are to provide an overview of the extant evidence to understand how dance is used for individuals with fibromyalgia; to examine the extent, range and nature of research activity in the area; and to determine the value of undertaking a full systematic review. Methods: Scoping reviews are useful to comprehensively and systematically map the literature and identify key evidence, or research gaps. The search strategy will involve electronic databases including: Medline; EMBASE, CENTRAL, PsycInfo, CINAHL, LILACS, AMED, International Bibliography of Theatre and Dance, PEDro, Trip, Proquest Theses/Dissertations, Web of Science, WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov. In designing the protocol, the study will be mapped in seven stages: 1) identifying the research questions, 2) identifying relevant studies, 3) study selection, 4) charting the data, 5) collating, summarising and reporting the results, 6) consultation, and 7) knowledge dissemination. Results: A large body of evidence from the past decades supports the use of exercise as one of the main non-pharmacological interventions for individuals with fibromyalgia. Conclusions: To our knowledge this will be the first attempt to systematically identify knowledge of dance as a potential intervention for adults with fibromyalgia. This scoping review offers a feasible means for describing the evidence specific to dance and fibromyalgia: results will provide unique insights concerning the breadth and depth of literature in the area. An analysis of this body of literature as a whole may reveal new research directions or unknown ways this intervention could strengthen current management approaches of the disease.
The servi-Share protocol: co-creating and evaluating a web-application mapping real-world healthcare services for students
Date Submitted: Oct 19, 2016
Open Peer Review Period: Oct 19, 2016 - Nov 2, 2016
Background: University students aged 18-30 years are a population group reporting low access to healthcare services with high rates of avoidance and delay of medical care. However they are at risk for...
Background: University students aged 18-30 years are a population group reporting low access to healthcare services with high rates of avoidance and delay of medical care. However they are at risk for several health problems, and regular medical consultations are recommended in this period of life. University students report not having appropriate information on recommended medical care and services. New digital devices are popular among the young and web-applications can be used to facilitate easy access to this type of information. A few eHealth tools have been developed with the purpose of showing real-world healthcare services and little is known on how such eHealth tools can improve access to care. Objective: This paper describes the processes of co-creating and evaluating the beta version of a web-application aimed at mapping and describing free or low-cost real-world healthcare services available in the Bordeaux area (France) and specifically addressed to university students. Methods: The co-creating process involve: (a) exploring the need of students to know and access real-world healthcare services; (b) identifying the real-world healthcare services of interest for students; and (c) deciding on user interface, and developing the beta version of the web-application. Finally, the evaluating process involve: (a) testing the beta version of the web-application with target audience (university students aged 18-30 years); (b) collecting their feedback through a satisfaction survey; and (c) planning a long-term evaluation. Results: The co-creation process of the beta version of the web-application was completed in August 2016 and is described in this manuscript. The evaluation process was started on September 7, 2016. We anticipate completing the project by December 2016. Conclusions: Web-applications are an innovative way to increase the health literacy of the young in terms of delivery of and access to care. The creation of web-applications must involve stakeholders, i.e. students and healthcare providers, for correctly identifying the real-world healthcare services to be displayed. Clinical Trial: Not applicable
A multi-center knowledge, attitude, behavior and practices survey on HIV, viral Hepatitis and STI among migrants from sub-Saharan Africa living in Germany
Date Submitted: Oct 17, 2016
Open Peer Review Period: Oct 17, 2016 - Oct 31, 2016
Background: Migration has an impact on the epidemiology of viral Hepatitis (HEP) and HIV in Germany, and migrants from sub-Saharan Africa (MisSA) in Germany are disproportionally affected by HIV. In t...
Background: Migration has an impact on the epidemiology of viral Hepatitis (HEP) and HIV in Germany, and migrants from sub-Saharan Africa (MisSA) in Germany are disproportionally affected by HIV. In the last 10 years a total of 10-15% of all newly diagnosed HIV-cases are MisSA, and 20-30% of them acquired HIV in Germany. Prevalence of HEP among MisSA in Germany is unknown, but Western Africa, where most MisSA in Germany originate from, reports the highest prevalence of hepatitis B worldwide. There is limited information on knowledge, attitudes, behaviors and practices (KABP) regarding HIV, HEP and sexually transmitted infections (STI), as MisSA are not reached with surveys targeting the general population. Objective: We initiated a multi-center KABP to determine HIV, HEP and STI-information and -prevention needs of MisSA in Germany. Methods: This is a multicenter cross-sectional KABP-survey regarding HIV, HEP and STI among MisSA living in Germany using convenience sampling. The study design was developed as a community-based participatory health research (CBPHR) project: HIV/STI-prevention specialists, key-persons from MisSA-communities and HIV/STI-researchers are involved in all steps of the research process. Trained peer researchers recruit participants in six study cities. Potential modes of survey administration are interview or self-completion, and questionnaire is available in English, French and German. Questions on knowledge about HIV, HEP and STI are presented as true statements; participants are asked if they had known information before. Focus groups with MisSA are conducted to interpret results. Data collection is taking place from October 2014 to November 2016. Results: Data collection is ongoing. Recruitment by peer researchers is concluded and we reached 3,040 eligible participants. We are currently analyzing the quantitative data and collecting qualitative data in focus groups and working group meetings to discuss the results in the respective study cities and to evaluate the application of participatory health research in epidemiological studies. We expect to present results by the beginning of 2017. Conclusions: We chose working with peer researchers for data collection to get access to a diverse sample of MisSA and reach particularly vulnerable sub-groups, such as MisSA without legal status. Being able to access hard-to-be-reached is one of the big advantages of CBPHR. The active inclusion of the persons under study results in higher acceptance of the research project in the target community and ultimately leads to better quality of collected data. Furthermore, the participation of MisSA in the development of study design and data collection assures a better understanding of the interests, needs and living conditions of this group.
Effectiveness of a 16-weeks multimodal exercise program in individuals with dementia: a multi-centre, group randomized controlled trial (Study Protocol)
Date Submitted: Oct 13, 2016
Open Peer Review Period: Oct 13, 2016 - Oct 27, 2016
Background: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affect...
Background: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. Objective: This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high quality multi-centre trial. Methods: A multi-centre group randomized controlled trial with baseline and post assessments will be performed. It is planned to enrol 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-weeks ritualized MEP especially developed for IWD. The effectiveness of the MEP on primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limb, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, visual spatial cognition). Results: Enrolment for the study started in May 2015. It is planned to complete post assessments by the beginning of 2017. Results are expected to be available in the first half of 2017. Conclusions: This study will contribute in enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterised by a dementia specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant for IWD suffering from multiple motor and cognitive impairments and often participating in limited physical activity. Clinical Trial: DRKS00010538 (German Clinical Trial Register, date of registration: 01 June 2016, retrospectively registered).
Negotiation of sexual consent among unmarried adolescents and young adults: A systematic scoping review protocol
Date Submitted: Oct 11, 2016
Open Peer Review Period: Oct 11, 2016 - Oct 25, 2016
Background: Introduction: Sexual assault/violence is a global public health problem. In recent years most preventive educational programs targeting the youth are focusing more on promoting understandi...
Background: Introduction: Sexual assault/violence is a global public health problem. In recent years most preventive educational programs targeting the youth are focusing more on promoting understanding and communication of sexual consent so as to reduce incidence of sexual assaults. Explicit understanding of communication and interpretation of sexual consent among unmarried adolescents and young adults is needed to strengthen such programs. The aim of this study is to map evidence on communication of sexual consent among unmarried adolescents and young adults in order to explore how they negotiate sexual consent in non-coercive situations. Methods and Analysis: The literature search will be performed using the following databases: CINAHL, PubMed, Google Scholar, and EBSCOhost (Medline, PsycINFO, PsycArticles, Health Source: Nursing/Academic Edition, Health Source – Complete, Academic Search Complete). Grey literature will be searched using relevant websites such as Google search and World Health Organization (www.who.int) based on inclusion criteria. Study titles, abstracts and full articles of each study will be screened for eligibility. Eligible studies will undergo data extraction. The Mixed Methods Appraisal Tool (MMAT) – Version 2011 will be used for quality appraisal of included studies. A thematic analysis will be carried out collectively by the research team to extract outcomes of interest. Discussion: It is anticipated that this review will shed light on how adolescents and young adults communicate and their interpretation of consent to sex. The findings of this study may guide future research and inform sexual assault prevention programs and policies. Dissemination: The study will be disseminated through publication and conferences presentation. PROSPERO registration number: CRD4201604843 Objective: The research team propose a scoping review of evidence from literature to understand how adolescents and young adults understand, communicate and interpret sexual consent as well as non-consent. The study questions are as follows: • How do unmarried adolescents and young adults understand sexual consent in relationships? • What verbal and non-verbal ways do they use to communicate sexual consent or non-consent to sexual activity in non-coercive situations? • How do young people interpret sexual consent or non-consent in non-coercive situations? Methods: Database: The search will be conducted using the CINAHL, PubMed, Google Scholar, and EBSCOhost (Medline, PsycINFO, PsycArticles, Health Source: Nursing/Academic Edition, Health Source – Complete, Academic Search Complete) literature databases. The researchers will search the listed literature database from January 1996 to October 2016. Search terms will include: ‘sexual consent’, ‘conceptualization of sexual consent’ ‘sexual consent behaviours’ ‘non-consent behaviours’ ‘sexual consent/non-consent and college’ ‘perception of sexual consent/non-consent’ ‘consent to sexual activity’ ‘sexual consent/non-consent and homosexual relationship’ ‘sexual consent/non-consent in heterosexual relationship’. Within each search string possible relevant searches will be combined using ‘OR’ (‘sexual consent or non-consent’). Separate search strings will be combined using AND (i.e ‘sexual consent/non-consent’ and ‘adolescents’ etc.). We will search the grey literature using the relevant websites such as Google search and World Health Organization (www.who.int). Using citation indexing in Web of Knowledge and citations facility in MEDLINE, we will embark on thorough reference-checking of relevant papers looking articles that cite our target papers. Electronic search will be recorded independently under the following heading: Date; keyword searched; database used and number of articles retrieved. Study inclusion and exclusion criteria Articles will be selected based on the inclusion and exclusion criteria as follow: Inclusion criteria: • Papers published since January 1996 to September 2016. • Evidences published in English languages. • Studies reporting on how a homosexual or/and bisexual or/and heterosexual adolescent and young adults communicate and interpret consent or non-consent/refusal. • Papers reporting on how adolescents and young adults interpret their partners’ sexual consent and/or non-consent. • Review articles will include: peer-reviewed journal articles, systematic reviews, scoping reviews and rapid reviews. • Grey literature will include: government and non-governmental organization reports and academic dissertations. • Full reports of studies to be considered include: mixed methods, quantitative and qualitative studies. • All Study designs such qualitative, quantitative, mixed methods studies etc. will be considered. Exclusion criteria: • Evidence published before the year 1996. • Evidence not published in English language. • No full journal article available. • Studies carried out how married people consent or non-consent to sexual activity. • Studies analyzing sexual consent as defined by government policies. • Studies and papers reporting on communication of sexual consent or refusal in coercive situations. Study Selection A two-step process will be used for study screening. Titles and abstracts (when available) will be screened independently by two reviewers against the inclusion criteria, if necessary a third reviewer will be consulted to resolve any discrepancy. Reasons for excluded studies will be stated. Then the eligible articles/papers will undergo a full text screening for data extraction (see figure 1). Results: Collating, Summarizing and reporting results Details regarding publication information [paper title, main author, journal and publication year; study design and setting (if relevant); target population and sampling (if relevant) and main findings] along with any additional informational pertinent to the overall scoping question will be recorded independently by each reviewer for all of the sources. The recorded information will be discussed and agreed on, so as to gain an overall perspective on the themes emerging from the literature addressing the scoping questions. The results of the study on behaviors and words that indicating sexual consent or refusal as well as behaviors and words interpreted as sexual consent or refusal will be coded independently by all each researcher. Afterward, the research team will meet to cross-examine the relationship between the emerging themes and the research questions. Finally, the study findings will then be discussed in relation to gaps in knowledge for future research, practice and policy. Conclusions: Conclusions This review will highlight how adolescents and young adults understand, communicate and interpret sexual consent as well as non-consent. It will serve as a basis for further research on this area. Clinical Trial: Not Applicable