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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 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"!
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Background: Excess weight is a major risk factor for chronic diseases. In Australia over 60% of adults are now overweight or obese. The overconsumption of energy-dense nutrient poor (EDNP) foods and l...
Background: Excess weight is a major risk factor for chronic diseases. In Australia over 60% of adults are now overweight or obese. The overconsumption of energy-dense nutrient poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed. Objective: This 1-year randomized controlled trial (6-month intervention; 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (18-65 years) who are overweight or obesity, recruited through a social marketing campaign (LiveLighter®). Methods: All eligible participants will complete demographics and lifestyle behaviors online at baseline, 6- and 12-months. Using a two stage randomization they will be allocated into one of three groups: 1) tailored feedback (TF) delivered via email at seven time points informed by objective dietary (mobile food record application™) and activity (wearable activity monitor) assessment; 2) active control (AC) receiving no tailored feedback, but undergoing the same objective assessments as TF; and 3) online control (OC) receiving no tailored feedback or objective assessments. Primary outcome measures at 6- and 12-months are changes in body mass, EDNP foods and beverage consumption and daily moderate-to-vigorous PA (measured via accelerometery). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors and cost-effectiveness. Results: Enrolment commenced in August 2017. Primary outcomes at 12-months will be available for analysis from September 2019. Conclusions: Tailored email feedback provided to individuals may provide a cost effective strategy to overcome existing barriers to improving diet and PA. If shown to be successful and cost-effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12617000554369.
Background: Clinical motion characterization in patients with Parkinson’s disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environme...
Background: Clinical motion characterization in patients with Parkinson’s disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environment can vary across time and from patient to patient. Appointments at the neurological outpatient clinic provide a limited understanding of the overall situation. In order to follow up on variations in the state of PD and heterogenity of symptoms, longer-term measurements performed outside the clinic could help to optimize and personalize therapies. Several wearable sensors have been used and algorithms have been developed to estimate the severity of symptoms in PD; however, large volumes of longitudinal recordings are rare. Home recordings have the potential benefit of providing more thorough and objective follow-up about the disease, while providing more information about the possible need to change medications or consider invasive secondary treatments. Objective: The primary objective of this study is to detect PD-related changes in walking patterns at home. The movement data are collected continuously and remotely at home during the normal lives of patients with Parkinson’s disease, as well as controls. The secondary objective is to study whether the registered medication intake can be identified from the collected movement data. Methods: The study protocol measures the activity using three different devices: (1) a smartphone with a built-in accelerometer, gyroscope, and phone orientation sensor, (2) a Movesense® smart sensor to measure movement data from the wrist, and (3) a Forciot® smart insole to measure the temporal and spatial distributions of the forces applied on the feet. The measurements are first collected during the appointment at the clinic through background interviews, a comprehensive Unified Parkinson’s Disease Rating Scale (UPDRS) test, and a 20-step walking test conducted by a trained clinical physiotherapist. Next, the subjects are asked to wear the smartphone at home for three consecutive days, and the data are transferred from the smartphone to a personal computer (PC) securely. Results: Data collection began in March 2018. The subject recruitment and data collection continued until the end of December 2018. The intended sample was 150 subjects, 100 of which were diagnosed with PD and 50 of which were control subjects. Conclusions: This study aims to produce an extensive movement sensor dataset recorded from PD patients in various phases of the disease, as well as a group of control subjects for effective and impactful comparison studies. The study also aims to develop data analysis methods to monitor PD symptoms and the effects of medication intake during normal life and outside of the clinic. Further applications of these methods may include tools for healthcare professionals to better monitor PD remotely or apply the tool to other movement disorders. Clinical Trial: This study is registered under ClinicalTrials.gov (NCT03366558). https://clinicaltrials.gov/ct2/show/NCT03366558?term=k%C3%A4veli&rank=1. Accessed: 2018-08-29. Archived at: http://www.webcitation.org/721n3uIqR
Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given...
Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that specifically target this age range often fail to demonstrate long-term effectiveness, and primarily focus on traditional weight-related behaviours, including diet, physical activity, and sedentary behaviour. However, recent research suggests that targeting non-traditional weight-related behaviours, such as sleep, screen time, and family meals, may be appropriate and more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviours long-term. Objective: The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2-4 years to promote positive parent-child interactions during three family routines, specifically, adequate sleep, regular family meals, and restricted screen time. Methods: The effects of the program on screen time (primary endpoint), frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the programme) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2-4 years of age who are currently exceeding screen use recommendations (that is, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the three family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4, and have been specified a priori in a statistical analysis plan prepared by the study statistician. Results: Trial recruitment opened in July 2018. Final follow-up is expected in December 2018, with trial findings expected to be available in early 2019. Conclusions: Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program. Clinical Trial: Australia New Zealand Clinical Trials Register ACTRN12618000823279
Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to lo...
Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to look after this type of cancer. In Mexico and Central America, as in many other countries, breast cancer prevention and control activities are performed permanently; but, there are no comprehensive public reports that could provide information on the policies that originated the programs, the number, type, and scope of these activities as well as the impact of the performed programs and actions. Objective: Therefore, this document’s goal is to present the design of a Scoping Review protocol about the policies and action programs for breast cancer care in Mexico and Central America, as well as its objectives and implementation plan. Methods: This Scoping Review protocol was developed on the basis of the methodological reference framework of Arksey and O’Malley (2005). A systematic search of the following electronic databases will be performed: MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Academic Search Complete (EbscoHost), ERIC, ISI Web of Science (Science Citation Index) in English, Cochrane, and MEDES-MEDicina in Spanish. The time scope of the search will be from 2000 trough 2018. Results: Since the data will not be obtained from primary sources, the approval of an ethics and research committee is not necessary. Data will be analyzed and presented in descriptive statistics and qualitative content analyses with analysis matrixes and semantic networks. The intention is to present the results to health authorities, conferences and publish them in an indexed journal. Conclusions: According to this proposal, we present a protocol for a Scoping Review-type literature revision based on the Arksey and O’Malley (2005) methodology during the first semester of 2019. According to this five-stage methodology, we will identify the scientific publications that present or analyze first-level action policies and programs for Breast Cancer care in Mexican women, as well as their results, if any. The outcome of this review will be used to define the bases of a research project intended to design an educational intervention strategy for the general public in Mexico, in order to deal with this important public health problem.
This manuscript needs more reviewersPeer-Review Me
Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individu...
Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health offers an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern US are uniquely positioned to be focal sites for conceptually-informed and thoroughly-evaluated PrEP implementation science studies. Objective: Assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US. Methods: Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted online survey of Title X clinic administrators and providers in the Southern US, followed by key informant interviews (KIIs) among a purposively-selected subset of responders to more comprehensively access inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South. Results: Phase 1 of Planning4PrEP research activities began in October 2017and are ongoing. To date, survey and KII administration is near completion with quantitative and qualitative data analysis scheduled to begin soon after data collection completion Conclusions: This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US.
This manuscript needs more reviewersPeer-Review Me
Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home,...
Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a readily addressed cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. Objective: Objective: To test a novel approach to motivate the adoption of home smoking restrictions (HSR) and to eliminate child SHS exposure by providing parents with objective, biomarker documentation of child exposure to tobacco toxins. Methods: Methods: From 2011 to 2013, 195 low-income, female smokers with children ≤ 10 years old, residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: Biomarker Feedback (n = 98) vs. Health Education, (n = 97). In-home assessments were administered at baseline, week 16 and week 26. Child urine nicotine, cotinine and NNAL (a metabolite of the known tobacco carcinogen, NNK), an objective measure of home SHS exposure (i.e., passive nicotine dosimeter) and a surface sample of residual (ie, third-hand) tobacco smoke were collected at all three time points. Primary outcome was dosimeter-verified, complete home smoking restrictions at 6-months post-randomization. Secondary outcomes included parental self report of smoking behavior change and child urine biomarker change. Results: Results : Data collection and analyses are complete and results are being interpreted. Conclusions: Discussion: The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting a child’s exposure to enviornmental tobacco smoke on parental smoking behavior change. Clinical Trial: Trial Registration: ClinicalTrials.gov Identifier: NCT01574560