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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-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.

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 (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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 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 proposals 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"!

 
 

Recent Articles:

  • Source: Flickr; Copyright: Cordelia Persen; URL: https://www.flickr.com/photos/25061723@N00/2094578010; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).
    Systematic Review Protocols

    Nov 12, 2019

    Prevalence of Malnutrition Among Elderly People in Iran: Protocol for a Systematic Review and Meta-Analysis

    Authors List:

    Abstract:

    Background: Malnutrition occurs following a decrease or an imbalance in the absorption of energy, protein, vitamins, and minerals because of numerous factors. Thus, it has serious and life-threatening consequences. To plan for this issue, we need information on the burden of this problem. Objective: The aim of this study is to determine the prevalence of malnutrition among elderly people in Iran. Methods: For the purpose of this study, papers, including original articles, theses, and conference proceedings on the prevalence of malnutrition among people aged 60 years and above, and have been published in national and international journals until September 2018 will be included without any language limitation. The following keywords along with their synonyms in Persian will be used in the literature search: malnutrition, elderly, and Iran. At first, the screening process will be conducted based on our inclusion and exclusion criteria. Then, the full text of the remaining articles will be read carefully, and eligible articles will be selected according to the objectives of the study. Next, the methodological quality of the selected papers will be reviewed, and the required information will be extracted from those with acceptable quality. Finally, a meta-analysis will be performed using the Stata software (version 14) when optimum criteria are met. It should be noted that all stages of screening, selection, quality assessment of primary studies, and data extraction will be performed by two reviewers independently. Results: This review is ongoing and will be completed at the end of 2019. Conclusions: This review aims to provide comprehensive evidence about the prevalence of malnutrition among elderly people in Iran. This can help Iranian health managers and policy makers make informed decisions for preventing malnutrition and promoting the health status of elderly people. Clinical Trial: PROSPERO CRD42018115358; https://tinyurl.com/y28su47m

  • Puerperal woman with her newborn. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/11/e12970/; License: Creative Commons Attribution (CC-BY).
    Early Reports

    Nov 12, 2019

    Impact of Perinatal Different Intrauterine Environments on Child Growth and Development: Planning and Baseline Data for a Cohort Study

    Authors List:

    Abstract:

    Background: Several studies have shown that exposure of the fetus and newborn to prenatal and perinatal events, respectively, may influence the health outcomes of the child throughout their life cycle. Objective: This study aimed to increase the knowledge on the impact of different intrauterine environments on child growth and development, as we know that pregnancy and early years are a window of opportunity for health promotion and prevention interventions of diseases. Methods: The recruitment occurred 24 to 48 hours after delivery and involved mothers and their newborns in 2 public hospitals in Porto Alegre, Brazil, from December 2011 to January 2016. The mothers-newborns dyads were allocated to 5 groups: diabetes mellitus, mothers with a clinical diagnosis of diabetes; systemic arterial hypertension (SAH), mothers with a clinical diagnosis of systematic arterial hypertensive disease during pregnancy; maternal smoking, mothers who smoked at any moment of gestation; small for gestational age (SGA), mothers with SGA newborns because of intrauterine growth restriction; and control, mothers without the clinical characteristics previously mentioned. Several protocols and anthropometric measurements were applied in the interviews at immediate postpartum and 7 and 15 days and 1, 3, and 6 months after birth. For this study, we analyzed only data collected during postpartum interviews. The statistical analyses were performed using Pearson chi-square test, Mann-Whitney test, or Kruskal-Wallis test with Dunn post hoc. The significance level was set at 5%. The Hospital Ethics and Research Committees approved the study. Results: Of the 485 eligible mothers-newborns dyads, 400 agreed to participate (82.5%, 400/485). As expected, newborns from the SGA group had significantly lower birth weight, smaller stature, and lower cephalic perimeter (P<.001). This group also had the highest percentage of primiparous women in comparison with other groups (P=.005) except for control. Mothers from the SAH group had the highest mean age, the highest percentage of cesarean sections, and presented greater gestational weight gain. Conclusions: In this study, we describe the planning and structure for the systematic follow-up of mother-newborn dyads in the first 6 months after birth, considering the important demographic and epidemiological transition scenario in Brazil. The results of this prospective longitudinal study may provide a better understanding of the causal mechanisms involved in health and life course disease related to different adverse intrauterine environments.

  • Source: Adobe Stock; Copyright: Djile; URL: https://stock.adobe.com/uk/images/young-woman-doctor-takes-a-swab-from-the-throat/228914771; License: Licensed by the authors.
    Proposals (non-eHealth)

    Nov 11, 2019

    Feasibility of Point-of-Care Testing for Influenza Within a National Primary Care Sentinel Surveillance Network in England: Protocol for a Mixed Methods Study

    Authors List:

    Abstract:

    Background: Point-of-care testing (POCT) for influenza promises to provide real-time information to influence clinical decision making and improve patient outcomes. Public Health England has published a toolkit to assist implementation of these tests in the UK National Health Service. Objective: A feasibility study will be undertaken to assess the implementation of influenza POCT in primary care as part of a sentinel surveillance network. Methods: We will conduct a mixed methods study to compare the sampling rates in practices using POCT and current virology swabbing practices not using POCT, and to understand the issues and barriers to implementation of influenza POCT in primary care workflows. The study will take place between March and May 2019. It will be nested in general practices that are part of the English national sentinel surveillance network run by the Royal College of General Practitioners Research and Surveillance Centre. The primary outcome is the number of valid influenza swabs taken and tested by the practices involved in the study using the new POCT. Results: A total of 6 practices were recruited, and data collection commenced on March 11, 2019. Moreover, 312 swab samples had been collected at the time of submission of the protocol, which was 32.5% (312/960) of the expected sample size. In addition, 68 samples were positive for influenza, which was 20.1% (68/338) of the expected sample size. Conclusions: To the best of our knowledge, this is the first time an evaluation study has been undertaken on POCT for influenza in general practice in the United Kingdom. This proposed study promises to shed light on the feasibility of implementation of POCT in primary care and on the views of practitioners about the use of influenza POCT in primary care, including its impact on primary care workflows.

  • Health eNav, a digital HIV care navigation intervention. Source: Freepik; Copyright: nensuria; URL: https://www.freepik.com/free-photo/two-young-entrepreneurs-working-coffee-shop_1623538.htm#page=1&query=hispanic%20man%20with%20phone&position=49; License: Licensed by JMIR.
    Non-Randomized Studies (funded, eHealth)

    Nov 8, 2019

    Implementing a Digital HIV Care Navigation Intervention (Health eNav): Protocol for a Feasibility Study

    Authors List:

    Abstract:

    Background: Young racial and ethnic minority men who have sex with men (MSM) and trans women are disproportionately affected by HIV and AIDS in the United States. Unrecognized infection, due to a low uptake of HIV testing, and poor linkage to care are driving forces of ongoing HIV transmission among young racial and ethnic minority MSM and trans women. Internet and mobile technologies, in combination with social network-based approaches, offer great potential to overcome and address barriers to care and effectively disseminate interventions. Objective: We describe Health eNavigation (Health eNav), a digital HIV care navigation intervention that extends supportive care structures beyond clinic walls to serve youth and young adults living with HIV who are newly diagnosed, not linked to care, out of care, and not virally suppressed, at times when they need support the most. Methods: This study leverages ecological momentary assessments for a period of 90 days and uses person-delivered short message service text messages to provide participants with digital HIV care navigation over a 6-month period. We aim to improve engagement, linkage, and retention in HIV care and improve viral suppression. Digital HIV care navigation includes the following components: (1) HIV care navigation, (2) health promotion, (3) motivational interviewing, and (4) digital social support. Results: Recruitment began on November 18, 2016; enrollment closed on May 31, 2018. Intervention delivery ended on November 30, 2018, and follow-up evaluations concluded on October 31, 2019. In this paper, we present baseline sample characteristics. Conclusions: We discuss real-world strategies and challenges in delivering the digital HIV care navigation intervention in a city-level, public health setting.

  • Patient with ulcerative colitis receives vedolizumab therapy through intravenous infusion. Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/close-up-doctor-s-hand-wearing-blue-gloves-giving-syringe-patient-s-arm_3894255.htm#query=doctor%20and%20patient%20needle&position=2#position=2&query=doctor%20and%20patient%20needle; License: Licensed by JMIR.
    Non-Randomized Study Protocols and...

    Nov 8, 2019

    Monitoring of Vedolizumab Infusion Therapy (MOVE-IT) Response With Fecal Inflammation Markers, Ultrasound, and Trough Serum Level in Patients With Ulcerative...

    Authors List:

    Abstract:

    Background: Vedolizumab has been shown to induce clinical remission in patients with active ulcerative colitis. Treatment with anti-integrin vedolizumab leads to clinical remission in 16.9% and clinical response in 47.1% of cases after 6 weeks. However, in clinical practice, no decision to discontinue or continue vedolizumab therapy is made until 14 weeks at the earliest. Objective: The aim of this study is to develop an algorithm for optimizing vedolizumab administration in patients with moderate-to-severe ulcerative colitis by calculating the probability of clinical response at week 14, on the basis of the data from week 6. Methods: This is a prospective, single-arm, multicentric, noninterventional, observational study with no interim analyses and a sample size of 35 evaluable patients. Results: The enrollment started in August 2018 and was still open at the date of submission. The study is expected to complete in September 2020. Conclusions: The early identification of patients who are responding to an integrin antibody is therapeutically beneficial. At the same time, patients who are not responding can be identified earlier. The development of a therapeutic algorithm for identifying patients as responders or nonresponders can thus help prescribing physicians avoid ineffective treatments and stop these very early.

  • Source: FreeDigitalPhotos; Copyright: franky242; URL: http://www.freedigitalphotos.net/images/woman-checking-her-pulse-using-the-apple-watch-photo-p351891; License: Licensed by the authors.
    RCTs - Protocols/Proposals (eHealth)

    Nov 7, 2019

    Home-Based Cardiac Rehabilitation in Brazil’s Public Health Care: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Coronary artery disease (CAD) is among the main causes of hospitalization and death worldwide, therefore, the implementation of programs to reduce its impact is necessary. Supervised cardiac rehabilitation has been shown to have positive effects on CAD control. However, there are barriers to patient participation in the traditional, face-to-face cardiac rehabilitation programs, mainly in low-resource environments. Objective: This study aimed to verify patient compliance to a home-based cardiac rehabilitation program, which includes unsupervised health education and physical exercises, guided by telephone. Moreover, we compare this new method to the traditional supervised cardiac rehabilitation offered in most hospital centers. Methods: We present here a two-arm, single-blinded, and randomized controlled design protocol, which compares the traditional cardiac rehabilitation (CenterRehab) with the home-based cardiac rehabilitation (Home-Based) in 72 patients affected by CAD. The primary outcome is the compliance to the cardiac rehabilitation sessions. The secondary outcomes (to evaluate effectiveness) include measurable variables such as functional capacity, CAD risk factors (blood pressure, waist circumference, glycemic, cholesterol levels, depressive symptoms, and the level of physical activity), the patient’s quality of life, the disease knowledge, and the morbidity rate. Parameters such as the program cost and the usability will also be evaluated. The programs will last 12 weeks, with a total of 60 rehabilitation and 6 educational sessions. Patients of the CenterRehab program will participate in 24 supervised sessions and 36 home sessions, while the patients of the Home-Based program will participate in 2 supervised sessions and 58 home sessions, guided by telephone. After the 12-week period all participants will be recommended to continue practicing physical exercises at home or at a community center, and they will be invited for re-evaluation after 3 months. The outcomes will be evaluated at baseline, and after 3 and 6 months. Results: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by October 2019. Conclusions: This is the first study in Brazil comparing the traditional cardiac rehabilitation approach with a novel, home-based protocol that uses an accessible and low-cost technology. If positive results are obtained, the study will contribute to establish a new and viable model of cardiac rehabilitation. Clinical Trial: ClinicalTrials.gov NCT03605992; https://clinicaltrials.gov/ct2/show/NCT03605992

  • The Implicit Learning in Stroke trial logo. Source: Image created by Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/11/e14222; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Nov 5, 2019

    Comparing the Impact of an Implicit Learning Approach With Standard Care on Recovery of Mobility Following Stroke: Protocol for a Pilot Cluster Randomized...

    Authors List:

    Abstract:

    Background: Although implicit and explicit learning approaches have been well investigated in healthy populations, there is less evidence regarding the relative benefits of each approach in clinical practice. Studies in stroke typically investigate single elements of an implicit learning approach (ILA; eg, reduced quantity feedback or an external focus of attention) within controlled environments. These studies predominantly evaluate performance, with few measuring this over time (ie, learning). The relevance and transferability of current research evidence into stroke rehabilitation is therefore limited. Objective: The objective of this study was to compare the ILA with standard care in the acute phase following stroke, to generate data and insights to inform the design of a definitive trial, and to understand patient and therapist perceptions of the ILA. Methods: This is a multicenter, assessor-blind, cluster randomized controlled pilot trial with nested qualitative evaluation. Stroke units (clusters) will be randomized to either ILA (intervention) or standard care (control) arms. Therapy teams at the intervention sites will be trained in the ILA and provided with an intervention manual. Those at the control sites will have minimal input from the research team, other than for data collection. Consent will be provided at the individual participant level. Once enrolled, participants will receive rehabilitation that focuses on lower limb recovery, using the designated approach. Measures will be taken at baseline, every 2 weeks until the point of discharge from hospital, and at 3 months post stroke onset. Measures include the Fugl Meyer Assessment (motor leg subsection), modified Rivermead Mobility Index, Swedish Postural Adjustment in Stroke Scale, and achievement of mobility milestones. Fidelity of the treatment approach will be monitored using observational video analysis. Focus groups and interviews will be used to gain insight into the perceptions of trial participants and clinical teams. Results: The first site opened to recruitment in February 2019. The opening of a further 5 sites will be staggered throughout 2019. Results are expected in early 2021. Conclusions: The findings from this mixed methods pilot study will be used to inform the design of a definitive study, comparing the ILA with standard care in acute stroke rehabilitation. Clinical Trial: ClinicalTrials.gov NCT03792126; https://clinicaltrials.gov/ct2/show/NCT03792126

  • Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/11/e14691/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (eHealth)

    Nov 1, 2019

    The Effects of Resistance Exercise With Blood Flow Restriction on Flow-Mediated Dilation and Arterial Stiffness in Elderly People With Low Gait Speed:...

    Authors List:

    Abstract:

    Background: During aging, a significant loss of muscle mass, strength, and power is associated with a decline in daily functional capacities. Traditionally, resistance training is prescribed to prevent or reverse the skeletal muscle weakness, but the required training intensity may be too demanding for older people with poor physical performance. Resistance exercise with blood flow moderation (KAATSU training) originally developed in Japan, combines physical training with blood flow restriction. It has been reported that KAATSU training enhances muscle hypertrophy in many populations. However, few studies have evaluated the effects of resistance exercises with blood flow restriction in elderly people and how this affects vascular structure and function. Objective: This study aims to evaluate (1) the acute and chronic effects of resistance exercises with blood flow restriction on vascular health in elderly people with low gait speed and (2) whether low-load resistance training with blood flow restriction elicits similar strength and gait speed gains to those elicited by conventional resistance training without blood flow restriction. Methods: This is an ongoing randomized controlled trial in elders with low gait speed. Overall, 2 study arms of 13 participants each perform resistance exercises with and without blood flow restriction. The 2 groups are as follows: the control group will perform conventional resistance exercises (60% of 1 repetition maximum) and the KAATSU group will perform the low-load resistance exercise with blood flow restriction (20% of 1 repetition maximum) for 12 weeks. Pulse wave velocity, venous occlusion plethysmography, and flow-mediated dilation by ultrasound are used to assess arterial stiffness, muscle blood flow, and endothelial function, respectively. The secondary outcomes are gait speed, strength, and quality of life. All measures will be performed before and after the training program. Results: This research study is in progress. Recruitment has started, and data collection is expected to finish in August 2020. Conclusions: The findings of this study will have important implications on the rehabilitation treatments in the elderly population. Clinical Trial: ClinicalTrials.gov NCT03272737; https://clinicaltrials.gov/ct2/show/NCT03272737

  • Source: Pxhere; Copyright: Pxhere; URL: https://pxhere.com/en/photo/591815; License: Public Domain (CC0).
    Non-Randomized Studies (funded,...

    Oct 30, 2019

    A Salutogenic Approach to Understanding the Potential of Green Programs for the Rehabilitation of Young Employees With Burnout: Protocol for a Mixed Method...

    Authors List:

    Abstract:

    Background: Burnout is the leading cause of absenteeism in the Netherlands, with associated sick leave costs amounting to around €1.8 billion. Studies have indicated that burnout complaints increased from almost 14.4% in 2014 to 17.3% in 2018, especially among employees between the ages of 18 and 35 years, and further increases are expected. Although there are many published articles on burnout, not much is known about what constitutes effective rehabilitation (ie, the reduction of burnout complaints and the facilitation of returning to work). At the same time, multiple pilot studies have indicated that green programs are effective in both reducing burnout complaints and facilitating return to work. Green programs have been developed by professionals experienced in using the natural environment to facilitate rehabilitation (eg, through green exercise and healing gardens). The literature nevertheless lacks comprehensive and contextual insight into what works and why. Objective: The overarching aim of this study is to explore the potential of green programs for young employees with burnout. We present the study protocol from an ongoing research project consisting of 2 phases, each composed of 2 research objectives that sequentially build upon each other. Methods: The study is based on a sequential design with 4 research objectives, using both qualitative and quantitative research methods. In the first phase, a systematic literature review (research objective 1) and in-depth interviews (research objective 2) will be used to explore mechanisms underlying the rehabilitation of young employees with burnout. In the second phase, a multicase study will be conducted to examine the extent to which green programs are built on mechanisms identified in the first phase (research objective 3). By employing a pretest and posttest design, a specific green program that captures most of those mechanisms will then be evaluated on its effect and process with regard to the rehabilitation of young employees with burnout (research objective 4). The project started in June 2018 and will continue through June 2022. Results: The first phase (research objectives 1 and 2) is intended to generate information on the mechanisms underlying the rehabilitation of young employees with burnout. The second phase (research objectives 3 and 4) is designed to demonstrate the extent to which and how the selected green program facilitates the rehabilitation of young employees with burnout. Conclusions: Understanding how green programs can facilitate the rehabilitation of young employees with burnout complaints can help to address this societal issue.

  • Source: Unsplash; Copyright: Campaign Creators; URL: https://unsplash.com/photos/pypeCEaJeZY; License: Licensed by JMIR.
    Systematic Review Protocols

    Oct 28, 2019

    Visual Analytic Tools and Techniques in Population Health and Health Services Research: Protocol for a Scoping Review

    Authors List:

    Abstract:

    Background: Visual analytics (VA) promotes the understanding of data using visual, interactive techniques and using analytic and visual engines. The analytic engine includes machine learning and other automated techniques, whereas common visual outputs include flow maps and spatiotemporal hotspots for studying service gaps and disease distribution. The principal objective of this scoping review is to examine the state of science on VA and the various tools, strategies, and frameworks used in population health and health services research (HSR). Objective: The purpose of this scoping review is to develop an overarching global view of established techniques, frameworks, and methods of VA in population health and HSR. The main objectives are to explore, map, and synthesize the literature related to VA in its application to the 2 main focus areas of health care. Methods: We will use established scoping review methods to meet the study objective. As the use of the term visual analytics is inconsistent, one of the major challenges was operationalizing the concepts for developing the search strategy, based on the 3 main concepts of population health, HSR, and VA. We included peer reviewed and grey literature sources from 2005 till March 2019 in the search. Independent teams of researchers will screen the titles, abstracts and full text articles, whereas an independent researcher will arbiter conflicts. Data will be abstracted and presented using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist and explanation by 2 independent researchers. Results: As of late August 2019, the scoping review is in the full-text screening stage. Data synthesis will follow and the first results are expected to be submitted for publication in December 2019. In this protocol, the methods for undertaking this scoping review are detailed. We present how we operationalized the varied concepts of population health, health services, and VA. The main results of the scoping review will synthesize peer reviewed and grey literature sources on the main methods of VA in the interrelated fields of population health and health services research from January 2005 till March 2019. Conclusions: VA is being increasingly used and integrated with emerging technologies to support decision making using large data sets. This scoping review of the VA tools, strategies, and frameworks applied to population health and health services aims to increase awareness of this approach for uptake by decision makers working within and toward developing learning health systems globally. Clinical Trial: Not applicable.

  • Source: Flickr; Copyright: Howard Ignatius; URL: https://www.flickr.com/photos/howardignatius/10952969694/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).
    RCTs - Protocols/Proposals (non-eHealth)

    Oct 21, 2019

    Targeting the Infant Gut Microbiota Through a Perinatal Educational Dietary Intervention: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: The early life gut microbiota are an important regulator of the biological pathways contributing toward the pathogenesis of noncommunicable disease. It is unclear whether improvements to perinatal diet quality could alter the infant gut microbiota. Objective: The aim of this study is to assess the efficacy of a perinatal educational dietary intervention in influencing gut microbiota in mothers and infants 4 weeks after birth. Methods: The Healthy Parents, Healthy Kids randomized controlled trial aimed to recruit 90 pregnant women from Melbourne, Victoria, Australia. At week 26 of gestation, women were randomized to receive dietary advice from their doctor (n=45), or additionally receive a dietary intervention (n=45). The intervention included an educational workshop and 2 support calls aiming to align participants’ diets with the Australian Dietary Guidelines and increase intakes of prebiotic and probiotic foods. The educational design focused on active learning and self-assessment. Behavior change techniques were used to support dietary adherence, and the target behavior was eating for the gut microbiota. Exclusion criteria were age under 18 years, diagnosed mental illnesses, obesity, diabetes mellitus, diagnosed bowel conditions, exclusion diets, illicit drug use, antibiotic use, prebiotic or probiotic supplementation, and those lacking dietary autonomy. The primary outcome measure is a between-group difference in alpha diversity in infant stool collected 4 weeks after birth. Secondary outcomes include evaluating the efficacy of the intervention in influencing infant and maternal stool microbial composition and short chain fatty acid concentrations, epigenetic profile, and markers of inflammation and stress, as well as changes in maternal dietary intake and well-being. The study and intervention feasibility and acceptance will also be evaluated as secondary outcomes. Results: The study results are yet to be written. The first participant was enrolled on July 28, 2016, and the final follow-up assessment was completed on October 11, 2017. Conclusions: Data from this study will provide new insights regarding the ability of interventions targeting the perinatal diet to alter the maternal and infant gut microbiota. If this intervention is proven, our findings will support larger studies aiming to guide the assembly of gut microbiota in early life. Clinical Trial: Australian Clinical Trials Registration Number ACTRN12616000936426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370939

  • Source: i yunmai / Unsplash; Copyright: i yunmai; URL: https://unsplash.com/photos/5jctAMjz21A; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (funded,...

    Oct 18, 2019

    Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled...

    Authors List:

    Abstract:

    Background: Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). Objective: This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group. Methods: This RCT will enroll and randomize 64 patients over an 18-month period. Results: Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. Conclusions: It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. Clinical Trial: ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467.

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  • Developing a blockchain-based supply chain system for advanced therapies: study protocol

    Date Submitted: Nov 11, 2019

    Open Peer Review Period: Nov 11, 2019 - Nov 18, 2019

    Background: Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases such as leukaemia and lymphoma. However, they can be complicated a...

    Background: Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases such as leukaemia and lymphoma. However, they can be complicated and expensive to deliver due to their sensitivity to environment, troublesome tissue, cell, or genetic material sourcing and complicated regulatory requirements Objective: This study aims to create a novel connected supply chain logistics and manufacturing management platform based on blockchain, with cell and gene therapy as a use case. Objectives are to define the requirements and perform feasibility evaluations on the use of blockchain for standardized manufacturing and establishment of chain of custody for the needle-to-needle delivery of autologous cell and gene therapies. A way of lowering overall regulatory compliance costs for running a network of facilities operating similar or parallel processes will be evaluated by lower monitoring costs through publishing zero-knowledge proofs and product release by exception. Methods: The study will use blockchain technologies to digitally connect and integrate supply chain with manufacturing to address the security, scheduling and communication issues between advanced therapy treatment centres and manufacturing facilities in order to realise a transparent, secure, automated and cost-effective solution to the delivery of these life-saving therapies. An agile software development methodology will be used to develop, implement, and evaluate the system. The system will adhere to EU and US Good Manufacturing Practices and regulatory requirements. Results: This is a proposed protocol and results pending. Conclusions: The successful implementation of the integrated blockchain solution to supply chain and manufacturing of advanced therapies can push the industry standards towards a safer and more secure therapy delivery process.

  • Teaching Real World Evidence: A Systematic Review Protocol

    Date Submitted: Nov 6, 2019

    Open Peer Review Period: Nov 6, 2019 - Nov 13, 2019

    Background: Real world evidence (RWE) refers to observational healthcare data beyond clinical trial data. It holds promise of transforming healthcare as a new form of evidence to support decision-make...

    Background: Real world evidence (RWE) refers to observational healthcare data beyond clinical trial data. It holds promise of transforming healthcare as a new form of evidence to support decision-makers in making decisions in developing and regulating medicines. As the importance of RWE is recognised by industry and regulatory bodies, teaching RWE becomes an important matter to evaluate and refine in order to develop future researchers and stakeholders who can better integrate RWE into the routine development of medicine. Objective: The aim of this review is to understand how real world evidence is currently being taught. From this landscape study, the insufficiencies of current education of RWE can be identified and subsequently inform future education policies around RWE and its sub-facets. Methods: We will search Medline, Embase, PsycINFO, HMIC, Cochrane and Web of Science for published studies using a combination of keywords and subject headings related to RWE and education. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria, and any discrepancies will then be discussed and resolved. The quality of the selected literature will be assessed using the CASP Systematic Review checklist. Results: Data from eligible publications will be abstracted into a predesigned form in order to better understand the current state of education of RWE and inform future RWE education directions and policies. Conclusions: The subsequent systematic review will be published in a peer-reviewed journal.

  • Application of “Internet of Things” in Cell-Based Therapy Delivery: A Systematic Review Protocol

    Date Submitted: Nov 6, 2019

    Open Peer Review Period: Nov 6, 2019 - Nov 13, 2019

    Background: Internet of Things (IoT) or Industry 4.0, represents a ‘smart’ shift to more interconnected manufacturing processes where individual entities within the supply chain communicate with e...

    Background: Internet of Things (IoT) or Industry 4.0, represents a ‘smart’ shift to more interconnected manufacturing processes where individual entities within the supply chain communicate with each other in order to achieve greater flexibility and responsiveness in manufacturing and leaner manufacturing to reduce cost of production. IoT has proven itself instrumental in driving leaner manufacturing and more efficient systems in other industries such as transportation and logistics. While cell-based therapeutic products hold the promise of transforming various diseases, the delivery of these products is complex and challenging. Objective: This review aims to understand the applicability of IoT in cell-based product supply chain and delivery. Methods: We will search Medline, EMBASE (OvidSP), Web of Science, Cochrane Library & HEED, Scopus, ACM digital library, INSPEC, ScienceDirect and the IEEE Xplore Digital Library for studies published after 2008 using a combination of keywords and subject headings related to IoT used in cell therapies. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria, and any discrepancies will then be discussed and resolved. The quality of the selected literature will be assessed using the CASP Systematic Review checklist. Results: Data from eligible publications will be abstracted into a predesigned form in order to map the current and future directions of the technologies, application and challenges in the implementation of IoT in regenerative medicine. Conclusions: This study is an analysis of publicly available primary and secondary literature and therefore does not require ethical review. The executed study conducted later will be published in a peer-reviewed journal in accordance with PRISMA guidelines.

  • Effectiveness of conversational agents (virtual assistants) in healthcare: protocol for a systematic review

    Date Submitted: Nov 6, 2019

    Open Peer Review Period: Nov 6, 2019 - Nov 13, 2019

    Background: Conversational agents have evolved in recent decades to become multimodal, multifunctional platforms that have the potential to automate a diverse range of health-related activities, supp...

    Background: Conversational agents have evolved in recent decades to become multimodal, multifunctional platforms that have the potential to automate a diverse range of health-related activities, supporting the general public, patients and physicians. Multiple studies have reported the development of these agents and recent systematic reviews have described the scope of use of conversational agents in healthcare. However, there is little focus on the effectiveness of these systems, thus the viability and applicability of these systems is unclear. Objective: The objective of this systematic review is to assess the effectiveness of conversational agents in healthcare and to identify limitations, adverse events and areas for future investigation of these agents. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols will be used to structure this protocol. The focus of the systematic review is guided by a population, intervention, comparator, and outcome framework . A systematic search of PubMed (Medline), EMBASE, CINAHL, and Web of Science will be conducted. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will extract and validate data, respectively, from included studies into a standardised form and conduct quality appraisal. Results: At the time of writing, we have begun a preliminary literature search and piloting of the study selection process. Conclusions: This systematic review aims to clarify the effectiveness, limitations and future applications of conversational agents in healthcare. Our findings may be used to inform future development of conversational agents and further the personalisation of care.

  • Mobile apps for health behaviour change: a systematic review protocol

    Date Submitted: Nov 6, 2019

    Open Peer Review Period: Nov 6, 2019 - Nov 13, 2019

    Background: The popularity and ubiquity of mobile apps has rapidly expanded in the past decade. With a growing focus on patient interaction with health management, mobile apps are increasingly used to...

    Background: The popularity and ubiquity of mobile apps has rapidly expanded in the past decade. With a growing focus on patient interaction with health management, mobile apps are increasingly used to monitor health and deliver behavioural interventions. The large variation in these mobile health apps - their target patient group, health behaviour, and behavioural change strategy - has resulted in a large but incohesive body of literature. Objective: The purpose of this protocol is to identify the current state, theories behind, and effectiveness of mobile apps for health behavior change. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) will be used to structure this protocol. The focus of the systematic review is guided by a population, intervention, comparator, and outcome framework (PICO). A systematic search of Medline, EMBASE, CINAHL, and Web of Science will be conducted. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data from included studies into a standardised form, which will be validated by a second reviewer. Results: Pre-search protocol; results pending Conclusions: This systematic review will summarize the current mobile app technologies and their effectiveness, usability, and coherence with behaviour change theory. It will identify areas of improvement and help inform the development of more effective and engaging mobile health apps.

  • IoT-enabled technologies for weight management in children and young people: a systematic review protocol

    Date Submitted: Nov 6, 2019

    Open Peer Review Period: Nov 6, 2019 - Nov 13, 2019

    Background: Childhood obesity is a serious global issue, leading to greater medical spending in obesity-related diseases such as cardiovascular diseases and diabetes. There is a need for healthcare se...

    Background: Childhood obesity is a serious global issue, leading to greater medical spending in obesity-related diseases such as cardiovascular diseases and diabetes. There is a need for healthcare services that link health behaviour, such as diet and physical activity, to risk factors and provides better advice and feedback to users, which Internet of Things-enabled technologies could facilitate. Objective: The objective of the systematic review will be to identify available Internet of Things-enabled technologies for weight management of children and young people (users below the age of 18). Also it will aim to understand the use, effectiveness and feasibility of these technologies. Methods: We will search Medline, PubMed, Web of Science, Scopus, ProQuest Central and the IEEE Xplore Digital Library for studies published after 2010 using a combination of keywords and subject headings related to health activity tracking, youth and Internet of Things. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the included studies will be assessed using the Critical Appraisal Skills Programme (CASP) checklists. Data from included studies will be extracted into a predesigned form to identify the types of devices or apps, Internet of Things applications and health outcomes related to weight management. Results: A preliminary search on Medline returned 484 results. The full systematic review will be conducted within the next 12 months and the publication of the final review and meta-analysis is expected at the beginning of the year 2020. Conclusions: The effectiveness and feasibility of physical activity trackers and consumer wearables for different patient groups have been well reviewed but there are currently no published reviews that look into these technologies in the wider Internet of Things context. This review aims to address this gap by examining Internet of Things-enabled technologies that are designed for youth weight management, and thus inform further research and clinical studies to reduce childhood obesity.

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