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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).
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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Introduction: Pressure ulcers and deep tissue injuries, collectively known as pressure injures (PrI) are serious complications causing staggering costs and human suffering with over 200 reported risk...
Introduction: Pressure ulcers and deep tissue injuries, collectively known as pressure injures (PrI) are serious complications causing staggering costs and human suffering with over 200 reported risk factors from many domains. Primary PrI prevention seeks to prevent initial incidence, while secondary PU/DTI prevention seeks to decrease chronic recurrence. Clinical practice guidelines (CPG) combine evidence based practice and expert opinion to aid clinicians in the goal of achieving best practices for primary and secondary prevention. The correction of all risk factors can be both overwhelming and impractical to implement in clinical practice. There is a need to develop effective clinical tools to prioritize the multiple recommendations of CPG but there is limited guidance on how to prioritize based on individual cases. Bioinformatics platforms enable data management to support clinical decision support and user-interface development for complex clinical challenges such as PrI prevention care planning. Objective/Hypothesis: The central hypothesis of the study is that the individual’s risk factor profile can provide the basis for adaptive personalized care planning for PU prevention based on CPG prioritization. The study objective is to develop the Spinal Cord Injury Pressure Ulcer and Deep tissue injury (SCIPUD+) Resource to support personalized care planning for primary and secondary PU/DTI prevention. Methods: The study is employing a retrospective electronic health record (EHR) chart review of over 75 factors known to be relevant for PrI risk in individuals with SCI and routinely recorded in the EHR. We also perform tissue health assessments of a selected sub-group. A systems approach is being used to develop and validate the SCIPUD+ Resource incorporating the many risk factor domains associated with PU/DTI primary and secondary prevention, ranging from the individual’s environment to local tissue health. Our multi-scale approach will leverage the strength of bioinformatics applied to an established national EHR system. A comprehensive model is being used to relate the primary outcome of interest (PU/DTI development) with over 75 PU/DTI risk factors using a retrospective chart review of 5000 individuals selected from the study cohort of over 36,000 individuals with SCI. A SCI PU/DTI specific ontology, SCIPUDO, is being developed to enable robust text-mining for data extraction from free form notes. Discussion: PU/DTI remains a highly significant source of morbidity for individuals with SCI. Personalized interactive care plans may decrease both initial PU formation and readmission rates for high-risk individuals. The project is using established EHR data to build a comprehensive structured model of environmental, social and clinical PrI risk factors. The comprehensive SCIPUD+ healthcare tool will be used to relate the primary outcome of interest (PrI development) with covariates including environmental, social, clinical, personal and tissue health profiles as well as possible interactions among some of these covariates. The study will result in a validated tool for personalized implementation of CPG recommendations and has great potential to change the standard of care for PrI clinical practice by enabling clinicians to provide personalized application of CPG priorities tailored to the needs of each at-risk individual with SCI.
Background: Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological...
Background: Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological rehabilitation. One approach is to use non-invasive brain stimulation techniques, such as transcranial direct current stimulation, to induce a neuroplastic response. When delivered in combination with rehabilitation exercises, there is some evidence that transcranial direct current stimulation is beneficial. However, responses to stimulation are highly variable. Therefore biomarkers predictive of response to stimulation would be valuable to help select appropriate people for this potentially beneficial treatment. Objective: The objective of this study is to investigate connectivity of the stimulation target, the ipsilesional motor cortex, as a biomarker predictive of response to anodal transcranial direct current stimulation in people with stroke. Methods: This study is a double blind, randomised controlled trial (RCT), with two parallel groups. A total of 60 participants with first ever ischemic stroke with motor impairment will undertake a two week (14 session) treatment for upper limb function (Graded Repetitive Arm Supplementary Program; GRASP). Participants will be randomised 2:1 to active:sham treatment groups. Those in the active treatment group will receive anodal transcranial direct current stimulation to the ipsilesional motor cortex at the start of each GRASP session. Those allocated to the sham treatment group will receive sham transcranial direct current stimulation. Behavioural assessments of upper limb function will be performed at baseline, post treatment, 1 month follow-up and 3 months follow-up. Neurophysiological assessments will include magnetic resonance imaging (MRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) and will be performed at baseline, post treatment, 1 month follow-up (EEG and TMS only) and 3 months follow-up (EEG and TMS only). Results: Participants will be recruited between March 2018 and December 2018, with experimental testing concluding in March 2019. Conclusions: Identifying a biomarker predictive of response to transcranial direct current stimulation would greatly assist clinical utility of this novel treatment approach. Clinical Trial: Australia New Zealand Clinical Trials Registry; ACTRN12618000443291. Website http://www.ANZCTR.org.au/ACTRN12618000443291.aspx
Background: In the past decade, the introduction and expansion of vaccination against major causes of childhood respiratory diseases and public health interventions to reduce the burden of HIV/AIDS an...
Background: In the past decade, the introduction and expansion of vaccination against major causes of childhood respiratory diseases and public health interventions to reduce the burden of HIV/AIDS and malaria, may have changed the contribution of different pathogens to respiratory deaths worldwide. In sub-Saharan Africa, where burden of respiratory disease deaths is highest, information on cause of death remains inadequate due to poor access to healthcare and limited availability of diagnostic tools. Postmortem examination can aid in ascertainment of causes of death. Objective: This report describes the Pediatric Respiratory Etiology Surveillance Study (PRESS) which seeks to identify causes and etiologies associated with respiratory disease deaths among children 1-59 months old hospitalized with respiratory illness admitted to the Kenyatta National Hospital, the largest public hospital in Kenya, through postmortem examination coupled with innovative approaches to laboratory investigation. Methods: Using an existing hospital-based respiratory disease surveillance system, we prospectively followed enrolled children until end of clinical care or death. In case of death, parents/guardians were offered grief counseling and consent was sought for postmortem examination of their child. Study pathologists systematically collected lung tissue specimens using minimally invasive tissue sampling techniques followed by collection of lung and other tissue specimens during conventional autopsy. These tissues were tested using histopathology, immunohistochemistry and multiple-pathogen molecular-based assays to identify pathogens. For each case, clinical and laboratory data were reviewed by a team of pathologists, clinicians, laboratorians and epidemiologists to systematically assign a cause of and etiology associated with death. Results: no yet available Conclusions: Postmortem studies can help identify major pathogens contributing to respiratory-associated deaths in children. This information is needed to develop evidence-based prevention and treatment policies that target important causes of pediatric respiratory mortality and assist with prioritization of local resources. PRESS can also provide insights into the interpretation of results using multi-pathogen testing platforms in resource-limited settings.
Background: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and...
Background: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies due to challenges in identification and adherence to cART. Objective: Adolescent Trials Network 147: Comprehensive Adolescent Research and Engagement Studies: Acute HIV Infection in Youth is a longitudinal strategic prospective treatment study aimed to identify and promptly treat with cART recently diagnosed youth aged 12 to 24 years of age in Los Angeles and New Orleans who have acute, recent or established HIV infection, as determined by Fiebig stages I to VI on HIV-1 antibody western blot. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to ART are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time and correlate this data with duration of viral suppression. Methods: A total of 72 youth (36 acutely infected and 36 treatment naïve controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to standard of care HIV-1 management and followed for a period of two years. Assessments are conducted at specific time points throughout these two years of follow-up for monitoring of adherence to ART, virus load, magnitude of HIV reservoirs and presence of co-infections. Results: The study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of February 8, 2018, a total of 11 youth were enrolled, 3 with recently acquired and 8 with established HIV infection as determined by Fiebig staging. Recruitment and enrollment are ongoing. Conclusions: We hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, i.e., those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies. Clinical Trial: On June 20th, 2017, the protocol was registered with clinicaltrials.gov (NCT03205696)
Background: Despite a significant number of studies on female fertility following childhood, adolescent, and young adult (CAYA) cancer, studies establishing precise (dose-related) estimates of treatme...
Background: Despite a significant number of studies on female fertility following childhood, adolescent, and young adult (CAYA) cancer, studies establishing precise (dose-related) estimates of treatment-related risks are still scarce. Previous studies have been under-powered, did not include detailed treatment information, or were based on self-report only without any hormonal assessments. More precise assessments of who is at risk for sub- or infertility are needed. Objective: The objective of this paper is to describe the design and methods of two studies on female fertility (a cohort study and a nested case-control study) among female survivors of CAYA cancer performed within the European PanCareLIFE project. Methods: For the cohort study, which aims to evaluate the overall risk of fertility impairment, as well as the risk for specific subgroups of female CAYA cancer survivors, 13 institutions from 9 countries provide data on fertility impairment. Survivors are defined as being fertility impaired if they meet at least one of eight different criteria based on self-reported and/or hormonal data. For the nested case-control study, which aims to identify specific treatment-related risk factors associated with fertility impairment in addition to possible dose-response relationships, cases (fertility impaired survivors) are selected from the cohort study and matched to controls (survivors without fertility impairment) on a 1:2 basis. Results: Of the 10,998 survivors invited for the cohort study, data are available from 6,650 survivors, either questionnaire-based only (n=5,003), hormonal-based only (n=74), or both (n=1,573). For the nested case-control study, a total of 450 cases and 882 controls are identified. Conclusions: Results of both PanCareLIFE fertility studies will provide detailed insight into the risk of fertility impairment following CAYA cancer and diagnostic- or treatment-related factors associated with an increased risk. This will help clinicians to adequately counsel both girls and young women who are about to start anti-cancer treatment, as well as adult female CAYA cancer survivors, concerning future parenthood, and to timely refer them for fertility preservation. Ultimately, we aim to empower patients and survivors and improve their quality of life.
Background: Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, an...
Background: Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. Objective: The primary objective of this study is to evaluate the real-world long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers, utilizing web-based recruitment and follow-up. Genotypic and phenotypic predictors of cessation will also be explored. Methods: Design: This is a two-group parallel block randomized (1:1) open label clinical trial. Setting: The study will be conducted online, with baseline enrolment via the study’s website and follow-up by email. Medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Participants: Individuals who smoke 10 or more cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario, by word-of-mouth and through the internet. Interventions: Eligible participants will receive an email with a prescription for 12-weeks of assigned medication and a letter to take to their physician. Recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. Results: Measurements: The primary outcome measure is smoking status at 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted via email at 4, 8, 12, 26 and 52 weeks after start of treatment to assess point smoking prevalence and continuous smoking abstinence. Mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Personality characteristics will be assessed using the Big Five Aspect Scales. Conclusions: Comments: To our knowledge, this is the first randomized controlled trial to mass-distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost-effective with quit outcomes that are comparable to published clinical trials. Clinical Trial: Trial Registration: www.clinicaltrials.gov ClinicalTrials.gov Identifier: NCT02146911