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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 2016: 5.175)
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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Background: The absence of information on reproductive cancer in Black men in South Africa creates a knowledge gap about health outcomes. Consequently, it is necessary to map the existing information...
Background: The absence of information on reproductive cancer in Black men in South Africa creates a knowledge gap about health outcomes. Consequently, it is necessary to map the existing information in order to formulate research that addresses the knowledge gap. To establish the range, nature and extent of published research on reproductive cancer in Black men in South Africa, an intensive scoping literature search has been designed. Methods: This study is a rigorous scoping review, conducted by five researchers and intends to explore and uncover the depths of existing research and identify research gaps. The literature search is conducted through online databases and policy documents. The process includes title, abstract and paper review and data abstraction, as espoused by Arksey and O’Malley (2005). Data is analysed using critical thematic analysis. This is mostly a web-based search no human subjects are to be used and does not require obtaining ethics clearance. Discussion: no other scoping or systematic review have been conducted on this topic from the continent. Therefore there is no coherent evidence that indicates the research gaps for future research on reproductive cancer for Black men. The proposed scoping review is necessary to advance science borne of a systematic approach. This scoping protocol outlines the methodology for critical literature appraisal to identify the topics in literature on Black men with reproductive cancer and possibly point out to new areas of research gaps. Conclusion: This protocol is sufficient for the purposes of this study and contributes meaningfully to research on male reproductive cancers in South Africa. This protocol also provides an audit trial to ensure scientific rigour and reproducibility of the research findings
Introduction: A Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided...
Introduction: A Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. Objectives: • To collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes. • Evaluate Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017. • To compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls. • Assess survival to discharge rate, and 30 day survival rate in patients receiving intervention from the designated shock team. • Create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. Methods: Retrospective and prospective data will be collected in patients cared for at IHVI with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data in patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock Team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. 142 patient were identified with two readmissions. Of 140 patients 123 met inclusion criteria. The remaining patients demonstrated 63 % survival to discharge rate, exceeding the historical norms of 45- 50%. Early intervention by a multidisciplinary team improves survival and quality of life in the clinically complex cardiogenic shock population. Clinical Trials: NCT03378739
Background: There is a significant revolving door of incarceration among homeless adults. Homeless adults who receive the professional coordination of individualized care (i.e., case management) durin...
Background: There is a significant revolving door of incarceration among homeless adults. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. This is because case managers work to meet the various needs of their clients by helping them to overcome barriers to needed services (e.g., food, clothing, housing, job training, substance abuse and mental health treatment, medical care, medication, social support, proof of identification, legal aid). Many barriers (e.g., limited transportation, inability to schedule appointments, limited knowledge of available services) prevent homeless adults who were recently released from incarceration from obtaining available case management, crisis management, substance abuse, and mental health services. Objective: The Link2Care study will assess the effectiveness of a smart phone application for increasing case management and treatment service utilization, and in turn reducing homelessness and re-arrest. The goals of this research are to: 1) assess the impact of an innovative smart phone application that will prompt and directly link recently incarcerated homeless adults to community-based case management services and resources, and 2) utilize in-person and smart phone-based assessments to identify key variables (e.g., alcohol/drug use, social support, psychological distress, quality of life) that predict continued homelessness and re-arrest. Methods: Homeless adults (N=432) who enroll in a shelter based Homeless Recovery Program after release from the Dallas County Jail will be randomly assigned to one of three treatment groups: 1) usual shelter-based case management (UCM), 2) UCM plus a study provided smart phone (UCM+SP), and 3) UCM with a study-provided smart phone that is preloaded with an innovative case management app (SPCM). Those assigned to SPCM receive smart phones that prompt (twice weekly) connections to shelter-based case managers. The app will also offer direct links to case managers (available during normal business hours) and crisis interventionists (available 24 hours a day, 7 days a week), with the touch of a button. Results: Recruitment is expected to begin in the spring of 2018, and the study will conclude in 2021. Conclusions: This research represents an important step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the U.S. Clinical Trial: NCT03399500
Background: While nutrition is a widely accepted tool for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has gre...
Background: While nutrition is a widely accepted tool for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential, however, it is complicated to implement. There is a need for products based on nutrition-related gene test results which are easily understood, accessible and utilized. Objective: The primary objective of this study is to compare the efficacy of a non-practitioner assisted direct-to-consumer (DTC) self-driven approach to nutrigenomics versus a personalized practitioner-led method. The secondary aims are to use this data combined with participant feedback to generate more effective nutrigenomics-based products. Methods: This 4-month study used a mixed-methods design that included: 1) a phase 1 randomized control trial that examined the effectiveness of a multi-faceted, nutrition-based gene test (components assessed included the major nutrients, food tolerances, food taste and preferences, and vitamins) in changing health behaviours; followed by 2) qualitative investigation that explored participants’ experiences. The study recruited 55 healthy males and females (35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene-test results plus personalized nutrition report) and 19 were assigned to the control group (gene-test results report emailed). Both groups received follow-up emails with nutrition-related tips and reminders. The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), self-efficacy, quality of life and anthropometrics (BMI, waist:hip) measured at baseline, post-intervention (3 and 6 weeks), and the final visit. After the study has been completed, participants in the control group will also receive their personalized nutrition report. Results: To date, only three participants have dropped out due to reasons such as not completing all required data collection forms or they were later found to be ineligible (retention of 95% of participants). Most participants are female, married, and had post-secondary education. Conclusions: This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. While the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate exhibit a great degree of interest in this field, and a definite need for further studies. Clinical Trial: The study protocol is registered with U.S. National Library of Medicine (www.clinicaltrials.gov; Trial registration #NCT03310814).
Background: High-risk prescribing, adverse drug events and avoidable adverse drug event hospitalisations are common. The single greatest risk factor for high-risk prescribing and adverse drug events i...
Background: High-risk prescribing, adverse drug events and avoidable adverse drug event hospitalisations are common. The single greatest risk factor for high-risk prescribing and adverse drug events is the number of medicines a person is taking. More people are living longer and taking more medicines for multiple long-term conditions. Most on-going prescribing occurs in primary care. The most effective, cost-effective, and practical approach to safer prescribing in primary care is not yet known. Objective: To test the effect of the Safer Prescribing And Care for the Elderly (SPACE) intervention on high-risk prescribing of non-steroidal anti-inflammatory and anti-platelet medicines, and related adverse drug event hospitalisations. Methods: Cluster randomised controlled trial. The clusters will be primary care practices. Data collection and analysis will be at the level of patient. Results: Recruitment will start in 2018. Conclusions: This study addresses an important translational gap, testing an intervention designed to prompt medicines review and support safer prescribing in routine primary care practice. Clinical Trial: Australian New Zealand Clinical Trials Registry: ACTRN12618000034235 12/01/2018 http://www.ANZCTR.org.au/ACTRN12618000034235.aspx
Background: Intimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidenc...
Background: Intimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidence of mental illness, namely depressive and anxiety disorders, as well as post-traumatic stress disorder (PTSD). Moreover, literature endorses cognitive behavioral therapy (CBT) intervention for those with symptomology consistent with anxiety disorders, mood disorders and PTSD; however, efficacy has not been evaluated among a population of pregnant survivors of IPV. Objective: To explore the efficacy of trauma-informed cognitive behavioral therapy on maternal and child health outcomes for pregnant women with PTSD, depression, or anxiety symptomology resulting from IPV; and to test the validity and feasibility of study methodology to support the successful implementation of a full-scale randomized controlled trial. Methods: The PATH (Promoting Attachment Through Healing) study will utilize a mixed-methods approach grounded in an intersectional feminist framework to explore the effectiveness of trauma-informed CBT for pregnant survivors of IPV. Study participants will be recruited through a hospital-based Perinatal Mental Health Clinic (London, Ontario, Canada). Cohort 1: A feasibility sample of 20 pregnant women will be selected to engage in an eight-session antenatal CBT intervention facilitated by the program’s perinatal clinical nurse specialist (PCNS), with evaluation at baseline, and two-months postpartum (intervention and online question) and six and twelve months postpartum (online questionnaire only). Cohort 2: Concurrently, a retrospective audit of 100 medical charts (50 charts of perinatal women who received CBT and 50 charts of women who did not receive perinatal CBT) from the past five years. The efficacy of the intervention will be based on a reduction of mental illness symptomology, improved maternal-infant attachment, maternal coping, and maternal quality of life as well as feasibility of the protocol and acceptability of the intervention from the women’s perspective. Inductive content analysis of all qualitative data will be used to determine common themes. Additionally, descriptive statistics, including measures of central tendency and dispersion, will be computed for all continuous variables. Alternatively, frequency tables will be constructed for all categorical variables. Results: The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions: Findings will be utilized to assess the acceptability of the study methodology and protocol for a full-scale randomized controlled trial. Furthermore, if CBT is proven effective for treatment of pregnant survivors of IPV, this intervention could be readily adopted by healthcare and social support services, thereby contributing to an improved standard of care for this unique population. Clinical Trial: ClinicalTrials.gov 10016616