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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:

  • Jacaranda nurse and newborn. Source: Jacaranda Health; Copyright: Jacaranda Health; URL: https://jacarandahealth.org/blog/page/3/; License: Licensed by JMIR.

    INTERGROWTH-21st Gestational Dating and Fetal and Newborn Growth Standards in Peri-Urban Nairobi, Kenya: Quasi-Experimental Implementation Study Protocol

    Abstract:

    Background: The burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21st gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible. Objective: To scale up the INTERGROWTH-21st standards, it is essential to assess the feasibility and acceptability of their implementation and their effect on clinical decision-making in a low-resource clinical setting. Methods: This study protocol describes a pre-post, quasi-experimental implementation study of the standards at Jacaranda Health, a maternity hospital in peri-urban Nairobi, Kenya. All women with viable fetuses receiving antenatal and delivery services, their resulting newborns, and the clinicians caring for them from March 2016 to March 2018 are included. The study comprises a 12-month preimplementation phase, a 12-month implementation phase, and a 5-month post-implementation phase to be completed in August 2018. Quantitative clinical and qualitative data collected during the preimplementation and implementation phases will be assessed. A clinician survey was administered eight months into the implementation phase, month 20 of the study. Implementation outcomes include quantitative and qualitative analyses of feasibility, acceptability, adoption, appropriateness, fidelity, and penetration of the standards. Clinical outcomes include appropriateness of referral and effect of the standards on clinical care and decision-making. Descriptive analyses will be conducted, and comparisons will be made between pre- and postimplementation outcomes. Qualitative data will be analyzed using thematic coding and compared across time. The study was approved by the Amref Ethics and Scientific Review Committee (Kenya) and the Harvard University Institutional Review Board. Study results will be shared with stakeholders through conferences, seminars, publications, and knowledge management platforms. Results: From October 2016 to February 2017, over 90% of all full-time Jacaranda clinicians (26/28) received at least one of the three aspects of the INTERGROWTH-21st training: gestational dating ultrasound, fetal growth monitoring ultrasound, and neonatal anthropometry standards. Following the training, implementation and evaluation of the standards in Jacaranda Health’s clinical workflow will take place from March 2017 through March 5, 2018. Data analysis will be finalized, and results will be shared by August 2018. Conclusions: The findings of this study will have major implications on the national and global scale up of the INTERGROWTH-21st standards and on the process of scaling up global standards in general, particularly in limited-resource settings. Registered Report Identifier: RR1-10.2196/10293

  • CTBH Feb 2017 Workshop Participants (photo possibility 3). Source: Image created by the authors; Copyright: Center for Technology and Behavioral Health; License: Creative Commons Attribution (CC-BY).

    Workshop on Emerging Technology and Data Analytics for Behavioral Health

    Abstract:

    Wearable and portable digital devices can support self-monitoring for patients with chronic medical conditions, individuals seeking to reduce stress, and people seeking to modify health-related behaviors such as substance use or overeating. The resulting data may be used directly by a consumer, or shared with a clinician for treatment, a caregiver for assistance, or a health coach for support. The data can also be used by researchers to develop and evaluate just-in-time interventions that leverage mobile technology to help individuals manage their symptoms and behavior in real time and as needed. Such wearable systems have huge potential for promoting delivery of anywhere-anytime health care, improving public health, and enhancing the quality of life for many people. The Center for Technology and Behavioral Health at Dartmouth College, a P30 “Center of Excellence” supported by the National Institute on Drug Abuse at the National Institutes of Health, conducted a workshop in February 2017 on innovations in emerging technology, user-centered design, and data analytics for behavioral health, with presentations by a diverse range of experts in the field. The workshop focused on wearable and mobile technologies being used in clinical and research contexts, with an emphasis on applications in mental health, addiction, and health behavior change. In this paper, we summarize the workshop panels on mobile sensing, user experience design, statistics and machine learning, and privacy and security, and conclude with suggested research directions for this important and emerging field of applying digital approaches to behavioral health. Workshop insights yielded four key directions for future research: (1) a need for behavioral health researchers to work iteratively with experts in emerging technology and data analytics, (2) a need for research into optimal user-interface design for behavioral health technologies, (3) a need for privacy-oriented design from the beginning of a novel technology, and (4) the need to develop new analytical methods that can scale to thousands of individuals and billions of data points.

  • 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

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    Date Submitted: Jun 21, 2018

    Open Peer Review Period: Jun 22, 2018 - Jun 30, 2018

    Background: A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer’s disease (AD) and other forms of dementia in at-risk individuals...

    Background: A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer’s disease (AD) and other forms of dementia in at-risk individuals. The development of virtually delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar efficacy to brick and mortar options. Objective: The objectives of this study are to examine the impact of a remotely delivered lifestyle intervention on (1) cognitive function, (2) depression and anxiety, and (3) various lifestyle behaviors, including diet, exercise, and sleep. Supplemental analyses will explore participants’ engagement patterns with the program, as well as the relationships between program engagement and outcomes. Here we report the study design and data analysis plan, as well as the baseline participant characteristics of the sample for the virtual cognitive health (VC Health) study. Methods: Older adults (age 60-75) with subjective memory decline as measured by the Subjective Cognitive Decline (SCD-9) questionnaire, and who reported feeling worried about their memory decline, were eligible to participate in this single-arm pre-post study. All participants enrolled in the year-long virtual intervention, which consists of health coach-guided lifestyle change for improving diet, exercise, sleep, stress, and cognition. All components of this study were conducted virtually, including the collection of data and the administration of the intervention. Participants were assessed at baseline, 12 weeks, 24 weeks, and 52 weeks with online surveys and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test. Intention-to-treat analysis will be conducted on all outcomes. Results: A total of 85 participants enrolled in the intervention and 82 are included in the study sample (3 participants withdrew). The study cohort is 74% female, 88% Caucasian, 78% overweight or obese, and 67% have at least a college degree. The average baseline RBANS score was 95.9±11.1, which is within age-adjusted norms. The average SCD-9 score was 6.0±2.0, indicating minor subjective cognitive impairment at the beginning of the study. Average baseline Generalized Anxiety Disorder (GAD-7) scores were 6.2±4.5 and Patient Health Questionnaire (PHQ-9) scores were 8.5±4.9, indicating mild levels of anxiety and depression at baseline. Conclusions: Virtually delivered lifestyle interventions represent a scalable solution for the prevention or delay of AD. The results of this study will provide the first evidence for the efficacy of a fully remote intervention and lay the groundwork for future investigations. Clinical Trial: NCT02969460

  • A Customized Intervention Program Aiming at Improving Healthy Eating and Physical Activity among Preschool Children: Iran Healthy Start Study Protocol

    Date Submitted: Jun 18, 2018

    Open Peer Review Period: Jun 21, 2018 - Jul 5, 2018

    Background: Prevention of childhood obesity is a key approach to the primary prevention of non-communicable diseases. Several models, based on population health approach and aligned with ecological mo...

    Background: Prevention of childhood obesity is a key approach to the primary prevention of non-communicable diseases. Several models, based on population health approach and aligned with ecological models, are used to design childhood obesity prevention programs around the world. Objective: The purpose of this study is to determine the efficacy of “Iran Healthy Start (IHS)/Aghazi Salem, Koodake Irani” -the customized Iranian version of Canadian Healthy Start/Deport Santé health promotion program- which is now being developed in Mashhad University of Medical Sciences (Mashhad, Iran), and focuses on improving physical activity and healthy eating among preschool children. Methods: The intervention will be evaluated by a pilot randomized controlled design. The components of intervention are including customized Decoda online resources for children, implementation guide for educators and managers, training and monitoring, communication and knowledge exchange, building partnership and parent engagement. Outcomes include changes in anthropometry, physical activity level, nutritional risk status and dietary intake and quality of life. Results: Double burden of malnutrition in early years children is a major health concern in developing countries. This justifies the need for health promotion programs that specifically designed to target both over- and under-nutrition prevention. Conclusions: If the efficacy approved, Iran Healthy Start has the potential of a comprehensive health promotion program for young children whose life style behaviors can be improved toward a healthy future life in a nutrition transition setting. Clinical Trial: The study is registered in the Iranian Registry for Clinical Trials (IRCT) (ID: IRCT2016041927475N1-11/12/2016) and is accessible through the WHO database of clinical trial registries.

  • Hospital in Motion, a multidimensional implementation project to improve patients’ physical behaviour during hospitalization, a study protocol

    Date Submitted: Jun 19, 2018

    Open Peer Review Period: Jun 21, 2018 - Jul 5, 2018

    Background: Despite the evidence of the adverse consequences of immobility during hospitalization, patients spend most of the time in bed. While physical activity is a modifiable factor which can prev...

    Background: Despite the evidence of the adverse consequences of immobility during hospitalization, patients spend most of the time in bed. While physical activity is a modifiable factor which can prevent in-hospital functional decline, bed rest is deep rooted in the hospital culture. To attack this, a multidimensional approach is needed. Therefore, Hospital in Motion, a multidimensional implementation project, was designed to improve physical behaviour during hospitalization. Methods: The Hospital in Motion study will be implemented within two specialism (cardiology and oncology) in a Dutch University Medical Centre. Per ward, multidisciplinary teams are composed and follow a step-by-step multidimensional implementation approach which includes the development and implementation of tailored action plans with multiple interventions to stimulate physical activity in daily care. The aim of this study is to investigate the effectiveness of Hospital in Motion on physical behaviour, measured with the behavioural mapping method, one year after start of the project. A pre-post observational study is used to evaluate the effectiveness, including 80 patients per time point per specialism. In addition, the process evaluation will be measured per ward, with a caregivers survey, patient statements and semi-structured interviews with patients and caregivers. Conclusion: This study will provide information about both the effectiveness of the Hospital in Motion project on physical behaviour as in the procedures of an implementation process aimed to incorporate physical activity in usual care. These insights will be useful for others interested in changing physical behaviour during hospitalization.

  • Feasibility of supported online guided self-help for insomnia for young people attending child and adolescent mental health services

    Date Submitted: Jun 18, 2018

    Open Peer Review Period: Jun 21, 2018 - Jul 5, 2018

    Background: Sleep disturbance in adolescents is common with up to one third reporting significant symptoms of insomnia. Research with adults has demonstrated that online cognitive behavioural therapy...

    Background: Sleep disturbance in adolescents is common with up to one third reporting significant symptoms of insomnia. Research with adults has demonstrated that online cognitive behavioural therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking and we know little about whether CBTi would have similar effects with this younger population. Objective: This study aims to assess the feasibility of adding supported online CBT for insomnia to the usual care of young people aged 14-17 years attending specialist child and adolescent mental health services. Methods: This is an open trial where we will recruit young people (n=50) aged 14-17 attending specialist child and adolescent mental health services (CAMHS) with symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6 session, online CBTi self-help programme for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction and cognitive techniques which participants will be helped to apply through brief weekly telephone support calls. Questionnaires and interviews will be completed at baseline and post-intervention (8 weeks) and will assess sleep, symptoms of depression and anxiety and acceptability of Sleepio and telephone support. Results: Recruitment started in May 2018 and will continue until the end of September 2018. Conclusions: This study will provide preliminary evidence about whether supported online CBTi is acceptable to young people with mental health problems and the post-intervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomised trial to determine the effectiveness of Sleepio should be undertaken. Clinical Trial: N/A

  • A Multi-Country Cohort to Estimate Vaccine Effectiveness against Hospitalized Influenza during Pregnancy

    Date Submitted: Jun 18, 2018

    Open Peer Review Period: Jun 21, 2018 - Jul 5, 2018

    Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE...

    Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges. The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention, Abt Associates, and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include: 1) estimating the incidence of influenza-associated ARFI hospitalization during pregnancy; 2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza to those who were not tested; 3) describing the severity of influenza and non-influenza ARFI hospitalization during pregnancy; 4) describing the clinical course of respiratory syncytial virus (RSV)-associated hospitalization during pregnancy; 5) describing influenza vaccination coverage in pregnant women; and 6) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization vs. other non-influenza ARFI hospitalizations. For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged 18 through 50 years whose pregnancies overlapped with local influenza seasons from 2010 through 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction. In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international parternships created for these analyses may be useful and informative for future influenza studies.

  • Design and rationale of the Ready to Reduce Risk (3R) Study: A randomised controlled trial of a group educational intervention with telephone and text messaging support to improve medication adherence for the primary prevention of cardiovascular disease

    Date Submitted: Jun 21, 2018

    Open Peer Review Period: Jun 21, 2018 - Jul 5, 2018

    Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary pr...

    Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease (CVD) are lacking. Objective: The 3R (Ready to Reduce Risk) Study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. This protocol paper details the design and rationale for the study. Methods: An open, pragmatic, randomised controlled trial with 12 months follow-up. Participants were recruited from primary care and randomised on a 1:1 basis, stratified by sex and age, to either a control group (‘usual’ GP care) or an intervention group involving two group, facilitated education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognised behavioural change techniques. The primary outcome was medication adherence to statins. The primary measure is an objective, novel, urine-based biochemical measure of medication adherence. The Morisky 8-item Scale was also used to assess medication adherence. Secondary outcomes include changes in total cholesterol, blood pressure, high-density lipoprotein, TC:HDL ratio, body mass index , waist-to-hip ratio, waist circumference, smoking behaviour, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs and overall CVD risk score. Process outcomes relating to acceptability and feasibility of the 3R Intervention have also been considered. Results: 212 participants were recruited between May 2015 and March 2017. The 12 month follow-up data collection clinics were completed in April 2018 and data analysis will commence once all study data has be collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of CVD. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures Clinical Trial: ISRCTN16863160

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