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JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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Journal Description

 

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.

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"!

 
 

Recent Articles:

  • Source: Flickr; Copyright: Peter Stevens; URL: https://www.flickr.com/photos/nordique/180143065; License: Creative Commons Attribution (CC-BY).

    Development and Evaluation of an Ethical Guideline for Decisions to Limit Life-Prolonging Treatment in Advanced Cancer: Protocol for a Monocentric...

    Abstract:

    Background: Many patients with advanced cancer receive chemotherapy close to death and are referred too late to palliative or hospice care, and therefore die under therapy or in intensive care units. Oncologists still have difficulties in involving patients appropriately in decisions about limiting tumor-specific or life-prolonging treatment. Objective: The aim of this Ethics Policy for Advanced Care Planning and Limiting Treatment Study is to develop an ethical guideline for end-of-life decisions and to evaluate the impact of this guideline on clinical practice regarding the following target goals: reduction of decisional conflicts, improvement of documentation transparency and traceability, reduction of distress of the caregiver team, and better knowledge and consideration of patients’ preferences. Methods: This is a protocol for a pre-post interventional study that analyzes the clinical practice on treatment limitation before and after the guideline implementation. An embedded researcher design with a mixed-method approach encompassing both qualitative and quantitative methods is used. The study consists of three stages: (1) the preinterventional phase, (2) the intervention (development and implementation of the guideline), and 3) the postinterventional phase (evaluation of the guideline’s impact on clinical practice). We evaluate the process of decision-making related to limiting treatment from different perspectives of oncologists, nurses, and patients; comparing them to each other will allow us to develop the guideline based on the interests of all parties. Results: The first preintervention data of the project have already been published, which detailed a qualitative study with oncologists and oncology nurses (n=29), where different approaches to initiation of end-of-life discussions were ethically weighted. A framework for oncologists was elaborated, and the study favored an anticipatory approach of preparing patients for forgoing therapy throughout the course of disease. Another preimplementational study of current decision-making practice (n=567 patients documented) demonstrated that decisions to limit treatment preceded the death of many cancer patients (62/76, 82% of deceased patients). However, such decisions were usually made in the last week of life, which was relatively late. Conclusions: The intervention will be evaluated with respect to the following endpoints: better knowledge and consideration of patients’ treatment wishes; reduction of decisional conflicts; improvement of documentation transparency and traceability; and reduction of the psychological and moral distress of a caregiver team. Registered Report Identifier: RR1-10.2196/9698

  • Source: Image created by the Authors; Copyright: B. Braun Medical Inc; URL: http://www.researchprotocols.org/2018/6/e10446/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Types and Frequency of Infusion Pump Alarms: Protocol for a Retrospective Data Analysis

    Abstract:

    Background: The variety of alarms from all types of medical devices has increased from 6 to 40 in the last three decades, with today’s most critically ill patients experiencing as many as 45 alarms per hour. Alarm fatigue has been identified as a critical safety issue for clinical staff that can lead to potentially dangerous delays or nonresponse to actionable alarms, resulting in serious patient injury and death. To date, most research on medical device alarms has focused on the nonactionable alarms of physiological monitoring devices. While there have been some reports in the literature related to drug library alerts during the infusion pump programing sequence, research related to the types and frequencies of actionable infusion pump alarms remains largely unexplored. Objective: The objectives of this study protocol are to establish baseline data related to the types and frequency of infusion pump alarms from the B. Braun Outlook 400ES Safety Infusion System with the accompanying DoseTrac Infusion Management Software. Methods: The most recent consecutive 60-day period of backup hospital data received between April 2014 and February 2017 from 32 United States-based hospitals will be selected for analysis. Microsoft SQL Server (2012 - 11.0.5343.0 X64) will be used to manage the data with unique code written to sort data and perform descriptive analyses. A validated data management methodology will be utilized to clean and analyze the data. Data management procedures will include blinding, cleaning, and review of existing infusion data within the DoseTrac Infusion Management Software databases at each hospital. Patient-identifying data will be removed prior to merging into a dedicated and secure data repository. This pooled data will then be analyzed. Results: This exploratory study will analyze the aggregate alarm data for each hospital by care area, drug infused, time of day, and day of week, including: overall infusion pump alarm frequency (number of alarms per active infusion), duration of alarms (average, range, median), and type and frequency of alarms distributed by care area. Conclusions: Infusion pump alarm data collected and analyzed in this study will be used to help establish a baseline of infusion pump alarm types and relative frequencies. Understanding the incidences and characteristics of infusion pump alarms will result in more informed quality improvement recommendations to decrease and/or modify infusion pump alarms, and potentially reduce clinical staff alarm fatigue and improve patient safety.  Registered Report Identifier: RR1-10.2196/10446

  • Source: United States Africa Command; Copyright: US Air Force (Stephen Linch); URL: http://www.africom.mil/media-room/Article/8769/tanzania-partners-with-us-provides-medical-care-fo; License: Public Domain (CC0).

    A Putative Role of Apolipoprotein L1 Polymorphism in Renal Parenchymal Scarring Following Febrile Urinary Tract Infection in Nigerian Under-Five Children:...

    Abstract:

    Background: Although urinary tract infection (UTI) resolves with prompt treatment in a majority of children, some children, especially those aged less than 5 years, also develop renal parenchymal scarring (RPS). RPS causes high blood pressure that may lead to severe chronic kidney disease and end-stage renal disease (ESRD). Although the risk of UTI is higher in white children than in black children, it is unknown whether RPS is more common in white children than in black children as data are scarce in this regard. A common genetic predisposition to kidney disease in African Americans and the sub-Saharan African blacks is the possession of apolipoprotein L1 (APOL1). APOL1 risk variants regulate the production of APOL1. APOL1 circulates in the blood, and it is also found in the kidney tissue. While circulating, APOL1 kills the trypanosome parasites; an increased APOL1 in kidney tissues, under the right environmental conditions, can also result in the death of kidney tissue (vascular endothelium, the podocytes, proximal tubules, and arterial cells), which, ultimately, is replaced by fibrous tissue. APOL1 may influence the development of RPS, as evidence affirms that its expression is increased in kidney tissue following UTI caused by bacteria. Thus, UTI may be a putative environmental risk factor responsible for APOL1-induced kidney injury. Objective: The aim of this proposal was to outline a study that seeks to determine if the possession of two copies of either G1 or G2 APOL1 variant increases the risk of having RPS, 6 months following a febrile UTI among Nigerian under-five children. Methods: This case-control association study seeks to determine whether the risk of RPS from febrile UTI is conditional on having 2 APOL1 risk alleles (either G1 or G2). Cases will be children with a confirmed RPS following a febrile UTI. Controls will be age-, gender-, and ethnic-matched children with a febrile UTI but without RPS. Children with vesicoureteral reflux and other congenital anomalies of the urinary tract are to be excluded. Association between predictor variables (ethnicity, APOL1 G1 or G2, and others) and RPS will be tested at bivariate logistic regression analyses. Predictors that attained significance at a P value of ˂.05 will be considered for multiple logistic regressions. Likelihood-based tests will be used for hypothesis testing. Estimation will be done for the effect size for each of the APOL1 haplotypes using a generalized linear model. Results: The study is expected to last for 3 years. Conclusions: The study is contingent on having a platform for undergoing a research-based PhD program in any willing university in Europe or elsewhere. The findings of this study will be used to improve the care of African children who may develop RPS following febrile UTI. Registered Report Identifier: RR1-10.2196/9514

  • Source: iStock by Getty Images; Copyright: Katie_Martynova; URL: https://www.istockphoto.com/no/photo/happy-young-family-playing-with-bubble-wands-in-park-outdoors-gm845344932-139751501; License: Licensed by the authors.

    Identification of Implementation Strategies Used for the Circle of Security-Virginia Family Model Intervention: Concept Mapping Study

    Abstract:

    Background: A reoccurring finding from health and clinical services is the failure to implement theory and research into practice and policy in appropriate and efficient ways, which is why it is essential to develop and identify implementation strategies, as they constitute the how-to component of translating and changing health practices. Objective: The aim of this study was to provide a systematic and comprehensive review of the implementation strategies that have been applied for the Circle of Security-Virginia Family (COS-VF) model by developing an implementation protocol. Methods: First, informal interviews and documents were analyzed using concept mapping to identify implementation strategies. All documentation from the Network for Infant Mental Health’s work with COS-VF was made available and included for analysis, and the participants were interviewed to validate the findings and add information not present in the archives. To avoid lack of clarity, an existing taxonomy of implementation strategies, the Expert Recommendations for Implementing Change, was used to conceptualize (ie, name and define) strategies. Second, the identified strategies were specified according to Proctor and colleagues’ recommendations for reporting in terms of seven dimensions: actor, the action, action targets, temporality, dose, implementation outcomes, and theoretical justification. This ensures a full description of the implementation strategies and how these should be used in practice. Results: Ten implementation strategies were identified: (1) develop educational materials, (2) conduct ongoing training, (3) audit and feedback, (4) make training dynamic, (5) distribute educational materials, (6) mandate change, (7) obtain formal commitments, (8) centralize technical assistance, (9) create or change credentialing and licensure standards, and (10) organize clinician implementation team meetings. Conclusions: This protocol provides a systematic and comprehensive overview of the implementation of the COS-VF in health services. It constitutes a blueprint for the implementation of COS-VF that supports the interpretation of subsequent evaluation studies, facilitates knowledge transfer and reproducibility of research results in practice, and eases the replication and comparison of implementation strategies in COS-VF and other interventions.

  • Online food allergy training. Source: Pexels; Copyright: Bruce Mars; URL: https://www.pexels.com/photo/photo-of-woman-using-her-laptop-935756/; License: Public Domain (CC0).

    Food Allergy Training for Schools and Restaurants (The Food Allergy Community Program): Protocol to Evaluate the Effectiveness of a Web-Based Program

    Abstract:

    Background: Food allergy is a growing public health concern. The literature suggests that a significant number of reactions occur in community services, such as schools and restaurants. Therefore, suitable training and education for education and catering professionals using viable and practical tools is needed. Objective: The objective of this study is to evaluate the effectiveness of a Web-based food allergy training program for professionals working in schools and restaurants, designed to improve knowledge and good practices in the community. Methods: Free learning programs which contain educational animated videos about food allergy were developed for professionals working at schools and restaurants. The learning programs comprise of nine 5-minute videos, developed in video animation format using GoAnimate, with a total course length of 45-60 minutes. The courses for professionals at both schools and restaurants include contents about food allergy epidemiology, clinical manifestations, diagnosis and treatment, dietary avoidance, emergencies, labelling, and accidental exposure prevention. Additionally, specific topics for work practices at schools and restaurants were provided. Food allergy knowledge survey tools were developed to access the knowledge and management skills about food allergy of school and restaurant staff, at baseline and at the end of the food allergy program. The courses will be provided on the e-learning platform of the University of Porto and professionals from catering and education sectors will be invited to participate. Results: Data collection will take place between September 2017 and October 2017, corresponding to a 2-month intervention. Final results will be disseminated in scientific journals and presented at national and international conferences. Conclusions: The Food Allergy Community Program intervention may improve school and restaurant professionals’ commitment and skills to deal with food allergy in the community. Furthermore, this e-intervention program will provide an innovative contribution to understanding the impact of electronic health technologies on the learning process and the development of strategies for community interventions. Registered Report Identifier: RR1-10.2196/9770

  • Research platform for cognitive bias modification (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/6/e153/; License: Creative Commons Attribution (CC-BY).

    Mobile Phone Cognitive Bias Modification Research Platform for Substance Use Disorders: Protocol for a Feasibility Study

    Abstract:

    Background: Cognitive biases refer to automatic attentional and interpretational tendencies, which could be retained by cognitive bias modification interventions. Cristea et al and Jones et al have published reviews (in 2016 and 2017 respectively) on the effectiveness of such interventions. The advancement of technologies such as electronic health (eHealth) and mobile health (mHealth) has led to them being harnessed for the delivery of cognitive bias modification. To date, at least eight studies have demonstrated the feasibility of mobile technologies for the delivery of cognitive bias modification. Most of the studies are limited to a description of the conventional cognitive bias modification methodology that has been adopted. None of the studies shared the developmental process for the methodology involved, such that future studies could adopt it in the cost-effective replication of such interventions. Objective: It is important to have a common platform that could facilitate the design and customization of cognitive bias modification interventions for a variety of psychiatric and addictive disorders. It is the aim of the current research protocol to describe the design of a research platform that allows for customization of cognitive bias modification interventions for addictive disorders. Methods: A multidisciplinary team of 2 addiction psychiatrists, a psychologist with expertise in cognitive bias modification, and a computer engineer, were involved in the development of the intervention. The proposed platform would comprise of a mobile phone version of the cognitive bias task which is controlled by a server that could customize the algorithm for the tasks and collate the reaction-time data in realtime. The server would also allow the researcher to program the specific set of images that will be present in the task. The mobile phone app would synchronize with the backend server in real-time. An open-sourced cross-platform gaming software from React Native was used in the current development. Results: Multimedia Appendix 1 contains a video demonstrating the operation of the app, as well as a sample dataset of the reaction times (used for the computation of attentional biases) captured by the app. Conclusions: The current design can be utilized for cognitive bias modification across a spectrum of disorders and is not limited to one disorder. It will be of value for future research to utilize the above platform and compare the efficacy of mHealth approaches, such as the one described in this study, with conventional Web-based approaches in the delivery of attentional bias modification interventions. Registered Report Identifier: RR1-10.2196/9740

  • Example of patient’s “My Program” for one week (montage). Source: The Authors / Smartmockups.com; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/5/e137/; License: Creative Commons Attribution (CC-BY).

    An eHealth Program for Patients Undergoing a Total Hip Arthroplasty: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Total hip arthroplasty is an effective surgical procedure commonly used worldwide for patients suffering the disabling effects of osteoarthritis when medical therapy is unsuccessful. Traditionally pre- and postoperative information for patients undergoing a hip arthroplasty has been provided by paper-based methods. Electronic health (eHealth) programs to support individualized patient education on preoperative preparation, in-patient care, and home rehabilitation have the potential to increase patient engagement, enhance patient recovery, and reduce potential postoperative complications. Objective: The aim of this study is to compare the addition of an eHealth program versus standard care for pre- and postoperative education on patient outcomes for primary total hip arthroplasty. Methods: One hundred patients undergoing a primary elective total hip arthroplasty will be recruited from a metropolitan hospital in Western Australia to participate in a 6-month parallel randomized control trial. Participants will be randomized to either the standard care group (n=50) and will be given the education booklet and enrolled to attend a 1-hour education session, or the intervention group (n=50), and will receive the same as the standard care plus access to an eHealth program titled “My Hip Journey.” The eHealth program encourages the patient to log in daily, from 2 weeks prior to surgery to 30 days postsurgery. The information on the platform will be aligned with the patient's individual surgical journey and will include exercises to be completed each day for the duration of the program. The primary outcome measure is the Hip Dysfunction and Osteoarthritis Outcome Score, version LK 2.0. Secondary outcome measures include the EuroQoL EQ-5D-5L, a 5-level 5-dimension quality of life measure, and the Self-Efficacy for Managing Chronic Disease Scale. Data will be collected at pre-admission (presurgery) and at 6 weeks, 3 months, and 6 months postsurgery. A patient satisfaction survey will be completed 6 weeks postsurgery and Web-based analytics will be collected 6 months postsurgery. A cost-effectiveness analysis, using the intention-to-treat principle, will be conducted from the hospital’s perspective. Results: Enrollment in the study commenced in January 2018 with recruitment due for completion towards the end of the year. The first results are expected to be submitted for publication in 2019. Conclusions: The outcomes and cost of using an eHealth program to support a patient’s recovery from a hip arthroplasty will be compared with standard care in this study. If the eHealth program is found to be effective, further implementation across clinical practice could lead to improvement in patient outcomes and other surgical areas could be incorporated. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001433392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373657&isReview=true (Archived by WebCite at http://www.webcitation.org/6yzoTuggx). Registered Report Identifier: RR1-10.2196/9654

  • Construction of latrines during the community-led total sanitation intervention. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/5/e145/; License: Creative Commons Attribution (CC-BY).

    An Integrated Approach to Control Soil-Transmitted Helminthiasis, Schistosomiasis, Intestinal Protozoa Infection, and Diarrhea: Protocol for a Cluster...

    Abstract:

    Background: The global strategy to control helminthiases (schistosomiasis and soil-transmitted helminthiasis) emphasizes preventive chemotherapy. However, in the absence of access to clean water, improved sanitation, and adequate hygiene, reinfection after treatment can occur rapidly. Integrated approaches might be necessary to sustain the benefits of preventive chemotherapy and make progress toward interruption of helminthiases transmission. Objective: The aim of this study was to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation, and health education on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection, and diarrhea in rural Côte d’Ivoire. Methods: In a first step, a community health education program was developed that includes an animated cartoon to promote improved hygiene and health targeting school-aged children, coupled with a health education theater for the entire community. In a second step, a cluster randomized trial was implemented in 56 communities of south-central Côte d’Ivoire with 4 intervention arms: (1) preventive chemotherapy; (2) preventive chemotherapy plus community-led total sanitation; (3) preventive chemotherapy plus health education; and (4) all 3 interventions combined. Before implementation of the aforementioned interventions, a baseline parasitologic, anthropometric, and hygiene-related knowledge, attitudes, practices, and beliefs survey was conducted. These surveys were repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators, and knowledge, attitudes, practices, and beliefs. Monitoring of diarrhea was done over a 24-month period at 2-week intervals, starting right after the baseline survey. Results: Key results from this cluster randomized trial will shed light on the effect of integrated approaches consisting of preventive chemotherapy, community-led total sanitation, and health education against infections with soil-transmitted helminths, schistosomes, an intestinal protozoa and prevention of diarrhea in a rural part of Côte d’Ivoire. Conclusions: The research provided new insights into the acceptability, strengths, and limitations of an integrated community-based control package targeting helminthiases, intestinal protozoa infections, and diarrhea in rural communities of Côte d’Ivoire. In the longer term, the study will allow determining the effect of the integrated control approach on infection patterns with parasitic worms and intestinal protozoa, diarrheal incidence, anthropometric measures, and hygiene-related knowledge, attitudes, practices, and beliefs. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 53102033; http://www.isrctn.com/ISRCTN53102033 (Archived by WebCite at http://www.webcitation.org/6wpnXEiHo) Registered Report Identifier: RR1-10.2196/9166

  • Development of computerized decision support directed at general practitioners and patients with knee osteoarthritis. Source: Pixabay; Copyright: Rawpixel; URL: https://pixabay.com/nl/computer-business-kantoor-3343887/; License: Public Domain (CC0).

    Development of a Tailored Intervention With Computerized Clinical Decision Support to Improve Quality of Care for Patients With Knee Osteoarthritis:...

    Abstract:

    Background: Clinical practice patterns greatly diverge from evidence-based recommendations to manage knee osteoarthritis conservatively before resorting to surgery. Objective: This study aimed to tailor a guideline-based computerized decision support (CDS) intervention that facilitates the conservative management of knee osteoarthritis. Methods: Experts with backgrounds in clinical medicine, research, implementation, or health informatics suggested the most important recommendations for implementation, how to develop an implementation strategy, and how to form the CDS algorithms. In 6 focus group sessions, 8 general practitioners and 22 patients from Norway, Belgium, and Finland discussed the suggested CDS intervention and identified factors that would be most critical for the success of the intervention. The focus group moderators used the GUideline Implementation with DEcision Support checklist, which we developed to support consideration of CDS success factors. Results: The experts prioritized 9 out of 22 recommendations for implementation. We formed the concept for 6 CDS algorithms to support implementation of these recommendations. The focus group suggested 59 unique factors that could affect the success of the presented CDS intervention. Five factors (out of the 59) were prioritized by focus group participants in every country, including the perceived potential to address the information needs of both patients and general practitioners; the credibility of CDS information; the timing of CDS for patients; and the need for personal dialogue about CDS between the general practitioner and the patient. Conclusions: The focus group participants supported the CDS intervention as a tool to improve the quality of care for patients with knee osteoarthritis through shared, evidence-based decision making. We aim to develop and implement the CDS based on these study results. Future research should address optimal ways to (1) provide patient-directed CDS, (2) enable more patient-specific CDS within the context of patient complexity, and (3) maintain user engagement with CDS over time.

  • Source: Karen Davison; Copyright: Karen Davison; URL: http://www.researchprotocols.org/2018/6/e115/; License: Licensed by JMIR.

    Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: Protocol for a Mixed-Methods Study

    Abstract:

    Background: Although nutrition interventions are a widely accepted resource 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 that are easily understood, accessible, and used. Objective: The primary objective of this study was to compare a nonpractitioner-assisted direct-to-consumer self-driven approach to nutrigenomics versus an integrated and personalized practitioner-led method. Methods: This 4-month study used a mixed-methods design that included (1) a phase 1 randomized controlled trial that examined the effectiveness of a multifaceted, nutrition-based gene test (components assessed included major nutrients, food tolerances, food taste and preferences, and micronutrients) in changing health behaviors, followed by (2) a qualitative investigation that explored participants’ experiences. The study recruited 55 healthy males and females (aged 35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene test results plus integrated and personalized nutrition report) and 19 were assigned to the control group (gene test results report emailed). The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), changes in measures on General Self-efficacy and Health-Related Quality of Life scales, and anthropometrics (body mass index, waist-to-hip ratio) measured at baseline, post intervention (3 and 6 weeks), and the final visit (week 9 post intervention). Results: Of the 478 individuals who expressed interest, 180 were invited (37.7%, 180/478) and completed the eligibility screening questionnaire; 73 of the 180 invited individuals (40.5%) were deemed eligible. Of the 73 individuals who were deemed to be eligible, 58 completed the baseline health questionnaire and food records (79%). Of these 58 individuals, 3 were excluded either because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%). 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. Although the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate show that there is a great degree of interest in this field. Given this interest and the fact that nutrigenomics is an evolving science, a need for continued research exists to further the understanding of the role of genetic variation and its role and applications in nutrition practice. Trial Registration: Clinicaltrials.gov NCT03310814; http://clinicaltrials.gov/ct2/show/NCT03310814 (Archived by WebCite at http://www.webcitation.org/6yGnU5deB) Registered Report Identifier: RR1-10.2196/9846

  • Source: Wikicommons; Copyright: Helen Frank; URL: https://commons.wikimedia.org/wiki/File:Australian_dentist_participates_in_humanitarian_mission_in_South_Pacific_110430-N-YY999-018.jpg; License: Public Domain (CC0).

    Human Papillomavirus and Oropharyngeal Cancer Among Indigenous Australians: Protocol for a Prevalence Study of Oral-Related Human Papillomavirus and...

    Abstract:

    Background: Oropharyngeal cancer is an important, understudied cancer affecting Aboriginal and Torres Strait Islander Australians. The human papillomavirus (HPV) is a significant risk factor for oropharyngeal cancer. Current generation HPV vaccines are effective against the 2 most common types of high-risk HPVs in cancer (hrHPVs 16/18). Objectives: This study aims (1) to yield population estimates of oncogenic genotypes of HPV in the mouth and oropharynx of defined Aboriginal and Torres Strait Islander populations; (2) to estimate the proportion of oropharyngeal cancer attributable to HPV among these Australian citizens; (3) to estimate the impact of HPV vaccination as currently implemented on rates of oropharyngeal cancer among Aboriginal and Torres Strait Islander Australians; and (4) taking into account impact on oropharyngeal as well as cervical cancer, to evaluate efficacy and cost-effectiveness of targeted extended HPV vaccination to older ages, among our study population. Methods: Our study design and operation is straightforward, with minimal impost on participants. It involves testing for carriage of hrHPV in the mouth and oropharynx among 1000 Aboriginal South Australians by simple saliva collection and with follow-up at 12 and 24 months, collection of sexual history at baseline, collection of information for estimating health state (quality-of-life) utilities at baseline, genotyping of viruses, predictive outcome and cost-effectiveness modeling, data interpretation and development of vaccination, and follow-up management strategies driven by the Aboriginal community. Results: Participant recruitment for this study commenced in February 2018 and enrollment is ongoing. The first results are expected to be submitted for publication in 2019. Conclusions: The project will have a number of important outcomes. Synthesis of evidence will enable generation of estimates of the burden of oropharyngeal cancer among Aboriginal and Torres Strait Islander Australians and indicate the likely effectiveness and cost-effectiveness of prevention. This will be important for health services planning, and for Aboriginal health worker and patient education. The results will also point to important areas where research efforts should be focused to improve outcomes in Aboriginal and Torres Strait Islander Australians with oropharyngeal cancer. There will be a strong focus on community engagement and accounting for the preferences of individuals and the community in control of HPV-related cancers. The project has international relevance in that it will be the first to systematically evaluate prevention of both cervical and oropharyngeal cancer in a high-risk Indigenous population taking into account all population, testing, and surveillance options. Registered Report Identifier: RR1-10.2196/10503

  • Source: National Health Service Stock Image Library; Copyright: National Health Service; License: Fair use/fair dealings.

    The General Practitioner Prompt Study to Reduce Cardiovascular and Renal Complications in Patients With Type 2 Diabetes and Renal Complications: Protocol and...

    Abstract:

    Background: Adherence to evidence-based cardiovascular risk factor targets in patients with type 2 diabetes and microalbuminuria has shown long-term reduction in mortality and morbidity. Strategies to achieve such adherence have been delivered at individual patient level and are not cost-effective. Health care professional-level intervention has the potential to promote better adherence at lower cost. Objective: The aim of this study was to assess the effectiveness of a multifactorial technology-driven intervention comprising health care professional training, a software prompt installed on practice systems, clinician email support, and enhanced performance and feedback reporting. Methods: A cluster randomized trial will be performed where the primary outcome is the proportion of eligible patients meeting tight cardiovascular risk factor targets, including systolic and diastolic blood pressure (BP; BP<130/80 mm Hg) and total cholesterol (TC; TC<3.5 mmol/L) at 24 months. Secondary outcomes include proportion of patients with glycated hemoglobin (HbA1c) <58 mmol/mol (7.5%), change in medication prescribing, changes in microalbuminuria and renal function (estimated glomerular filtration rate, eGFR), incidence of major adverse CV events and mortality, and coding accuracy. Cost-effectiveness of the intervention will also be assessed. Results: Among 2721 eligible patients, mean age was 62.9 (SD 10.0) years, and duration of diabetes was 10.46 (SD 7.22) years. Mean HbA1c was 59.3 (SD 17.4) mmol/mol; mean systolic and diastolic BP (mm Hg) were 134.3 (SD 14.6) and 76.1 (SD 9.5) mm Hg, respectively; and mean TC was 4.1 (SD 0.98) mmol/L. Overall, 131 out of 2721 (4.81%) patients achieved all 3 “tight” cardiovascular risk factor targets. Cardiovascular risk factor burden increased two-fold in those with eGFR<60 mL/min/1.73 m2 compared with those with eGFR≥60 mL/min/1.73 m2. Prevalence of microalbuminuria was 22.76%. In total, 1076 out of 2721 (39.54%) patients were coded for microalbuminuria or proteinuria on their primary care medical record. Conclusions: The general practitioner prompt study is the largest UK primary care-based, technology-driven, randomized controlled trial to support intensive intervention in high-risk group of multiethnic individuals with type 2 diabetes and microalbuminuria. This paper provides contemporary estimates for prevalent cardiovascular disease and adherence to evidence-based cardiovascular risk factor targets at baseline in a population with type 2 diabetes and microalbuminuria. The main trial results, including cost-effectiveness data, will be submitted for publication in 2018. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14918517; http://www.isrctn.com/ISRCTN14918517 (Archived by WebCite at http://www.webcitation.org/6zqm53wNA) Registered Report Identifier: RR1-10.2196/9588

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  • Testing the Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adults: A Randomized Controlled Trial (RCT)

    Date Submitted: Jun 14, 2018

    Open Peer Review Period: Jun 16, 2018 - Jun 30, 2018

    Background: Alcohol misuse and emotional problems (i.e., depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based...

    Background: Alcohol misuse and emotional problems (i.e., depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults. Objective: The main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems. Methods: A two-arm randomized controlled trial (RCT) design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8-weeks and participants will work through 12 modules. Modules will incorporate content based on principles of Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI). Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at three time points: at baseline, at the end of treatment (i.e., 8-weeks), and at follow-up (i.e., 24-weeks). Upon completion, data will be analyzed using Generalized Linear Mixed Models (GLMM). Results: Data collection will begin in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020. Conclusions: Currently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced in young adults. This research stands to provide an effective, accessible (i.e., online), and feasible option to treat the many struggling young adults in this country. Clinical Trial: Clinicaltrials.gov ID – NCT03406039

  • Unravelling the biopsychosocial factors of fatigue and sleep problems after traumatic brain injury: Study protocol for a multicenter longitudinal cohort study

    Date Submitted: Jun 14, 2018

    Open Peer Review Period: Jun 16, 2018 - Jun 30, 2018

    Background: Fatigue and sleep problems are common after traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory and can d...

    Background: Fatigue and sleep problems are common after traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory and can drastically impact the quality of life and societal participation of the patient and their family and friends. However, the etiology and development of these symptoms is still uncertain. Objective: The aim of this study is to examine the development of fatigue and sleep problems following moderate to severe TBI and explore the changes in underlying biological (pain, brain damage), psychological (emotional state) and social (support family, participation) factors across time. Methods: Longitudinal multicenter observational cohort study with four measurement points (3, 6, 12 and 18 months post injury) including subjective questionnaires and cognitive tasks, preceded by 7 nights of actigraphy combined with a sleep diary. Recruitment of 137 moderate to severe TBI patients presenting at emergency and neurology departments or rehabilitation centers across the Netherlands is anticipated. Results: The evolution of fatigue and sleep problems following TBI and their association with possible underlying biological (pain, brain damage), psychological (emotional state) and social (support family, participation) factors will be examined. Conclusions: To the authors’ knowledge this study is the first study that examines the development of both post-TBI fatigue and sleep longitudinally within a biopsychosocial model in moderate to severe TBI using both subjective and objective measures. Identification of modifiable factors such as mood and psychosocial stressors may give direction to the development of interventions for fatigue and sleep problems post-TBI. Clinical Trial: Dutch Trial Register NTR7162; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7162 (Archived by WebCite at http://www.webcitation.org/6z3mvNLuy)

  • A randomized controlled trial evaluating a novel just-in-time contextual mobile application intervention to reduce sodium intake in hypertension: Design and rationale for the LowSalt4Life trial

    Date Submitted: Jun 13, 2018

    Open Peer Review Period: Jun 16, 2018 - Jun 30, 2018

    Background: High sodium intake is a significant public health problem in the U.S. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants an...

    Background: High sodium intake is a significant public health problem in the U.S. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average U.S. diet coming from processed and restaurant foods. Objective: We propose that a mobile application intervention that promotes low sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low sodium diet in hypertension (HTN). Methods: This is a single center prospective open-label design, patients will be randomized to the mobile application or usual care for 8-week duration. Fifty patients greater than 18 years of age diagnosed with hypertension and on antihypertensive therapy for at least 3 months will be randomized in a 1:1 fashion stratified by gender. Study subjects will receive the mobile application, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint of is the change in estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include the change in sodium content of the food frequency questionnaire, confidence in following a low sodium diet, urine chloride and creatinine dipsticks and blood pressure. Conclusion: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages via a novel mobile application 8-week intervention on urinary sodium excretion in patients with HTN. By testing a novel mobile application intervention, LowSalt4Life, we will address a critical evidence gap in the care of HTN patients. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in HTN. Clinical Trial Registration: ClinicalTrials.gov NCT03099343 (https://clinicaltrials.gov/ct2/show/NCT03099343)

  • A virtual reality intervention for fear of movement for Veterans with chronic pain: Protocol for a pilot trial

    Date Submitted: Jun 13, 2018

    Open Peer Review Period: Jun 16, 2018 - Jun 30, 2018

    Background: A key concern for people with chronic pain is experiencing increased pain and/or re-injury. Consequently, individuals with chronic pain can develop a maladaptive fear of movement that lea...

    Background: A key concern for people with chronic pain is experiencing increased pain and/or re-injury. Consequently, individuals with chronic pain can develop a maladaptive fear of movement that leads to adverse functional consequences. A primary goal of chronic pain rehabilitation is re-engagement in feared movements through exposure. This is often challenging since safe movement can be uncomfortable. Virtual environments provide a promising opportunity to safely and gradually expose Veterans to movements that are avoided in the real world. The current study will utilize multiple virtual reality (VR) applications (APPs) of varying the intensity levels ranging from passive distraction from pain to active exposure to feared movement. The primary aims of this pilot are to examine VR as an adjunctive non-pharmacological intervention to assist with the adoption and implementation of skills to decrease fear of movement and increase overall functioning among Veterans with chronic pain. The second aim is to validate a hierarchy of VR Apps to assist in gradual exposure to feared movements. Methods: This study will be conducted in the Chronic Pain Rehabilitation Program (CPRP) at the James A. Haley Veterans Hospital, a unique inpatient program within the VA system. Participants will include up to 20 Veterans who receive a VR intervention as part of their physical therapy. Intake and discharge measures of pain and functional outcomes will be compared to a historical matched control group comprised from Veterans who previously completed the CPRP. A rating form containing qualitative and quantitative experiences will be administered following each VR session to assess feasibility and to validate the hierarchy. Discussion: This pilot study will inform the feasibility of a multi-site randomized controlled trial examining the clinical utility of using VR to reduce fear of movement and increase function among Veterans with chronic pain. VR has the advantage of being easily implemented both within VA healthcare settings as well as in Veterans’ own residences, where engagement in ongoing self-management approaches is often most challenging. Presumably, VR that is matched to patient functioning, progresses in intensity, immerses Veterans in the applications, and is perceived positively by Veterans, will result in positive functional outcomes.

  • Protocol for a Mixed-Methods Evaluation of a Massive Open Online Course on Real World Evidence

    Date Submitted: Jun 13, 2018

    Open Peer Review Period: Jun 16, 2018 - Jun 30, 2018

    Background: Increasing number of Massive Open Online Courses (MOOCs) are being used to train learners at scale in various healthcare related skills. However, many challenges in course delivery require...

    Background: Increasing number of Massive Open Online Courses (MOOCs) are being used to train learners at scale in various healthcare related skills. However, many challenges in course delivery require further understanding, for example, factors exploring the reasons for high MOOC dropout rates, recorded low social interaction between learners and the lack of understanding of the impact of a course facilitators’ presence in course engagement. There is a need to generate further evidence to explore these detriments to MOOC course delivery to enable enhanced course learning design. Objective: This protocol aims to describe the design of a study evaluating learners knowledge, skills and attitudes in a Massive Open Online Course (MOOC) about data science for healthcare. Methods: This study will use two evaluation models: 1) The RE-AIM framework and the 2) Kirkpatrick model drawing data from pre and post-course surveys and post-MOOC semi-structured interviews. The primary goal of the evaluation is to appraise participants' knowledge, skills, and attitude after taking the MOOC. Results: A summary of the research findings will be reported through a peer-reviewed journal and will be presented at an international conference. Conclusions: The proposed multi-method evaluation of the MOOC was determined based on the MOOC’s aims and objectives and the methodological approaches used to evaluate this type of a course. The MOOC evaluation will help appraise the effectiveness of the MOOC in delivering its intended objectives. Clinical Trial: Ethics approval for this study was obtained from Imperial College London through the Education Ethics Review Process (EERP) (EERP1617-030).

  • Valuable, but challenging! Experiences of codesigning an eHealth service for co-care of Parkinson’s disease

    Date Submitted: Jun 12, 2018

    Open Peer Review Period: Jun 15, 2018 - Jun 29, 2018

    Background: The need of services to support patient self-care and patient education has been emphasized for patients with chronic conditions. People with chronic conditions may spend many hours per ye...

    Background: The need of services to support patient self-care and patient education has been emphasized for patients with chronic conditions. People with chronic conditions may spend many hours per year in health and social care services, but the majority of time is spent in self-care. This has implications for how health care is best organized. The term co-care specifically stresses the combination of health care professionals’ and patients’ resources, supported by appropriate (digital) tools for information exchange, to achieve best possible health outcomes for patients. Developers of eHealth services need to consider both parties’ specific needs for the service to be successful. Research on participants’ experiences of participating in codesign sessions is scarce. Objective: The aim of this study was to describe different stakeholders’ (people with chronic conditions, health care professionals, and facilitators) overall experiences of participating in codesign workshops aimed at designing an eHealth service for co-care for Parkinson’s disease, with a particular focus on the perceptions of values and challenges of codesign, as well as improvement suggestions. Methods: Four half-day codesign workshops were performed with 7 people who have Parkinson’s disease and 9 health care professionals. Data were collected during the workshop series using formative evaluations with participants and facilitators after each workshop, researchers’ diary notes throughout the codesign process, and a web-based questionnaire after the final workshop. The quantitative data from the questionnaire were analyzed using descriptive statistics. The qualitative data were triangulated and analyzed inductively using qualitative content analysis. Results: The quantitative ratings showed that most participants had a positive general experience regarding the codesign workshops. The qualitative analysis resulted in six categories and 30 subcategories describing respondents’ perceptions of the values and challenges of codesign and their improvement suggestions. The categories concerned 1) desire for more stakeholder variation; 2) imbalance in the collaboration between stakeholders; 3) time-investment and commitment paradox; 4) desire for both flexibility and guidance; 5) relevant workshop content, but concerns about goal achievement; and 6) hopes and doubts about future care. Conclusions: Based on the identified values and challenges, some paradoxical experiences were revealed: a) a desire to involve more stakeholders in codesign, while preferring to work in separate groups; b) a desire for more preparation and discussions, while the required time investment was a concern; and c) the experience that codesign is valuable for improving care, while there are doubts about the realization of co-care in practice. The value of codesign is not mainly about creating new services; it’s about improving current practices to shape better care. The choice of methods needs to be adjusted to the stakeholder group and context, which will influence how they experience the process and outcomes of codesign.

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