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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: 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.
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
Background: Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of...
Background: Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of ageing communities; and are particularly relevant in the rehabilitation setting. Objective: In malnourished older adults, does the FREER intervention during and post-rehabilitation improve nutritional status, physical function, quality of life, service satisfaction, and hospital and aged care admission rates up to 3-months post-discharge, compared with usual care? Secondary outcomes evaluated include family carer burden, carer services satisfaction, and patient and carer experiences. This pilot study will also evaluate feasibility and intervention fidelity to inform a larger randomised controlled trial. Methods: This is the protocol for a mixed-methods two-arm historically-controlled prospective pilot intervention study. The historical control group has 30 participants, and the pilot intervention group aims to recruit 30 patient-carer pairs. The FREER intervention delivers nutrition counselling during rehabilitation, 3-months of post-discharge telehealth follow-up, and provides supportive resources using a novel model of patient-centred and carer-centred nutrition care. The primary outcome is nutritional status measured by the Scored Patient-Generated Subjective Global Assessment score. Qualitative outcomes such as experiences and perceptions of value will be measured using semi-structured interviews followed by thematic analysis. The process evaluation addresses intervention fidelity and feasibility. Results: Recruitment commenced on the 4th July 2018 and is ongoing, with eight patient-carer pairs recruited at the time of manuscript submission. Conclusions: This research will inform a larger randomised controlled trial, with potential for translation to health service policies and new models of dietetic care to support the optimisation of nutritional status across a continuum of nutrition care from rehabilitation to home. Clinical Trial: Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12618000338268).
Background: Discretionary food and beverages (products high in high in saturated fat, added sugars and salt) are detrimental to a healthy diet. Nevertheless, they provide 42% of total energy and accou...
Background: Discretionary food and beverages (products high in high in saturated fat, added sugars and salt) are detrimental to a healthy diet. Nevertheless, they provide 42% of total energy and account for 53% of food and beverage expenditure for remote living Aboriginal and Torres Strait Islander Australians, contributing to the excessive burden of chronic disease experienced by this population group. Objective: In collaboration with the Arnhem Land Progress Aboriginal Corporation (ALPA; which operates 25 stores in very remote Australia) we will test an intervention to reduce sales of discretionary products, by reducing their merchandising and substituting core products, in remote Australian communities. Methods: We will use a community-level randomised controlled pragmatic trial design. Stores randomised to the intervention group will be supported by ALPA to reduce merchandising of four food categories (sugar, sugar sweetened beverages, sweet biscuits and confectionery) that in total provide 64% of total energy from discretionary foods and 87% of total free sugars in very remote community stores. The remaining stores (50% of total) will serve as controls and conduct business as usual. Electronic store sales data will be collected at baseline, 12-weeks intervention and 24-weeks post intervention to objectively assess the primary outcome of percent change in purchases of free sugars (g/MJ) and secondary business- and diet-related outcomes. Critical to ensuring translation to improved store policies and healthier diets in remote Indigenous Australia we will conduct i) an in-depth implementation evaluation to assess fidelity; ii) a customer intercept survey to investigate the relationship between customer characteristics and discretionary food purchasing; and iii) a qualitative study to identify policy supports for scale-up of health enabling policy action in stores. Results: No results given as it is a protocol paper Conclusions: Novel pragmatic research approaches are needed to inform policy for healthy retail food environments. This research will greatly advance our understanding of how the retail food environment can be used to improve population level diet in the remote Australian Aboriginal and Torres Strait Islander context and retail settings globally. Clinical Trial: ACTRN 12618001588280