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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine, and their peer-review reports, if available (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

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

JMIR Res Protoc is fully open access, with full-text articles deposited in PubMed Central.

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.

JMIR Res Protoc is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposals have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • Source: Image created by the authors; Copyright: Sotirios Fouzas; URL: http://www.researchprotocols.org/2020/8/e20350/; License: Creative Commons Attribution (CC-BY).

    Lung Function Variability in Children and Adolescents With and Without Asthma (LUV Study): Protocol for a Prospective, Nonrandomized, Clinical Trial

    Abstract:

    Background: Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 second (FEV1) has been used in research to predict exacerbations in adults with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy children and adolescents and those with asthma. Objective: The objective of this study is the assessment of PEF and FEV1 variability in (1) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and (2) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. Methods: The study will include 100 healthy children and adolescents aged 6-18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in subjects with asthma). PEF and FEV1 measurements will be performed using an ultraportable spirometer (Spirobank Smart; MIR Medical International Research) capable of smartphone connection. Measurements will be performed twice a day between 7 AM and 9 AM and between 7 PM and 9 PM and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations among individuals with asthma. The anticipated duration of the study is 24 months. Results: The study is funded by the “C. Caratheodory” Programme of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020, and as of June 2020, 100 healthy children have been enrolled (74 of them have completed the measurements). The anticipated duration of the study is 24 months. The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020, and the results will be available for publication by October 2020. Conclusions: Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex, and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations. Trial Registration: ClinicalTrials.gov NCT04163146; https://clinicaltrials.gov/ct2/show/NCT04163146

  • Drink Less app. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2020/8/e18690; License: Creative Commons Attribution (CC-BY).

    Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial

    Abstract:

    Background: Drink Less is a behavior change app that aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11 am, asking users to “Please complete your mood and drinking diaries.” Previous analysis of Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour. To exploit a potential increase of vulnerability of excess drinking and opportunity to engage with the app in the evenings, we changed the delivery time from 11 am to 8 pm. We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user’s perceived usefulness of the app. Objective: The primary objective is to assess whether sending a notification at 8 pm increases behavioral engagement (opening the app) in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth, and frequency of engagement with Drink Less over the first 30 days after download. Methods: This is a protocol for a micro-randomized trial with two additional parallel arms. Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol. In the micro-randomized trial, participants will be randomized daily at 8 pm to receive no notification, a notification with text from the new message bank, or the standard message. The primary outcome is the time-varying, binary outcome of “Did the user open the app in the hour from 8 pm to 9 pm?”. The primary analysis will estimate the marginal relative risk for the notifications using an estimator developed for micro-randomized trials with binary outcomes. Participants randomized to the parallel arms will receive no notifications (Secondary Arm A), or the standard notification delivered daily at 11 am (Secondary Arm B) over 30 days, allowing the comparison of overall engagement between different notification delivery strategies. Results: Approval was granted by the University College of London’s Departmental Research Ethics Committee (CEHP/2016/556) on October 11, 2019, and The London School of Hygiene and Tropical Medicine Interventions Research Ethics Committee (17929) on November 27, 2019. Recruitment began on January 2, 2020, and is ongoing. Conclusions: Understanding how push notifications may impact engagement with a behavior change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalizable to other apps that target a variety of behavior changes.

  • Source: Freepik; Copyright: frimufilms; URL: https://www.freepik.com/free-photo/modern-residential-building_9192853.htm#page=1&query=house%20outside&position=7; License: Licensed by JMIR.

    Individualized Apartment Accommodation for People With Intellectual Disability: Protocol for a Qualitative Study Examining the Well-Being and Support...

    Authors List:

    Abstract:

    Background: Understanding the outcomes associated with both receiving and providing support to people with intellectual disability in specific settings can facilitate the alignment of health providers, community care providers, architects, and urban planners to strengthen levels of autonomy and community participation of people with intellectual disability living in the community. This study explores the impact of providing support (available 24 hours a day) for people with intellectual disability in a high-density apartment. It seeks the perspectives of people with intellectual disability who have moved into an apartment from a group home (where 4-6 people with disability live), their families, and support staff. It will enable comparison between two models of supported accommodation, group homes and individualized apartments, in a community setting. Objective: The aims of this study are to explore the impact of an individualized apartment model of supported accommodation in a high-density setting on the well-being, autonomy, and participation of people with intellectual disability living and receiving support; the experience of providing care or support; and how this setting impacts the logistics of how quality support is provided. Methods: Qualitative research methods were employed as the primary means of collecting and analyzing data. There are two main sources of data in this study: (1) semistructured interviews with participants in up to 3 waves (pre, post 1, and post 2) and (2) pre- and postoccupancy evaluation data on the design, layout, and location details of the built environments. Coded interview data will be paired with pre- and postoccupancy evaluations of the two accommodation settings. Results: As of May 2020, we have recruited 55 participants. There have been 96 interviews conducted in 2 waves with people who have moved into supported accommodation, families, and staff. Collected data are currently being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in late 2020. Conclusions: This paper sets out a study of an alternative housing and support model for people with intellectual disability. It will capture personal experiences of people with intellectual disability receiving support in an apartment compared to their experiences in a group home. It will also capture the experiences of support staff working in the new setting and reveal how this differs from a group home setting. The inclusion of pre (group home) and post (apartment integrated into a community setting) measures addresses evaluative and comparative questions around the nature and impacts of the small-scale apartment and support model for both those who live and receive support, and those who support them.

  • Source: In the Know intervention/ The Authors; Copyright: YTH an initiative of ETR/ Julie Tinker; URL: https://www.researchprotocols.org/2020/8/e18060; License: Licensed by the authors.

    Evaluating the Effectiveness of an Intervention Integrating Technology and In-Person Sexual Health Education for Adolescents (In the Know): Protocol for a...

    Abstract:

    Background: Access to a smartphone is nearly universal among American adolescents, and most of them have used the internet to seek health information. Integrating digital technologies into health program delivery may expand opportunities for youth to receive important health information, yet there are few rigorous studies assessing the effectiveness of this type of intervention. Objective: The purpose of this study is to assess the effectiveness of In the Know (ITK), a program integrating in-person and technology-based sexual health education for underserved adolescents. Methods: Youth were engaged in the development of the intervention, including the design of the digital technology and the curriculum content. The intervention focuses on 3 main areas: sexual health and contraceptive use, healthy relationships, and educational and career success. It includes an in-person, classroom component, along with a web-based component to complement and reinforce key content. A cluster randomized controlled trial is in progress among adolescents aged 13-19 years living in Fresno County, California. It is designed to examine the differences in self-reported health and behavioral outcomes among youth in the intervention and control groups at 3 and 9 months. Primary outcomes are condom and contraceptive use or no sex in the past 3 months and use of any clinical health services in the past 3 months. Secondary outcomes include the number of sexual partners in the past 3 months and knowledge of local clinical sexual health services. We will use mixed-effects linear and logistic regression models to assess differences between the intervention and control groups. Results: Trial enrollment began in October 2017 and ended in March 2020 with a total of 1260 participants. The mean age of the participants is 15.73 (SD 1.83) years, and 69.98% (867/1239) of the participants report being Hispanic or Latino. Study results will be available in 2021. Conclusions: ITK has the potential to improve contraceptive and clinic use among underserved youth. This trial will inform future youth-focused health interventions that are considering incorporating technology.

  • Scene from Tambua Mapema Plus explainer video. Source: www.creatures.africa; Copyright: The Authors; URL: https://www.youtube.com/watch?v=C7A_AatfKr4&feature=youtu.be; License: Licensed by the authors.

    A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a...

    Abstract:

    Background: Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. Objective: The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. Methods: A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. Results: Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. Conclusions: The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. Trial Registration: ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908

  • Enumerator interviewing a respondent using a tablet. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/8/e17619/; License: Licensed by JMIR.

    Using Machine Learning to Optimize the Quality of Survey Data: Protocol for a Use Case in India

    Abstract:

    Background: Data quality is vital for ensuring the accuracy, reliability, and validity of survey findings. Strategies for ensuring survey data quality have traditionally used quality assurance procedures. Data analytics is an increasingly vital part of survey quality assurance, particularly in light of the increasing use of tablets and other electronic tools, which enable rapid, if not real-time, data access. Routine data analytics are most often concerned with outlier analyses that monitor a series of data quality indicators, including response rates, missing data, and reliability of coefficients for test-retest interviews. Machine learning is emerging as a possible tool for enhancing real-time data monitoring by identifying trends in the data collection, which could compromise quality. Objective: This study aimed to describe methods for the quality assessment of a household survey using both traditional methods as well as machine learning analytics. Methods: In the Kilkari impact evaluation’s end-line survey amongst postpartum women (n=5095) in Madhya Pradesh, India, we plan to use both traditional and machine learning–based quality assurance procedures to improve the quality of survey data captured on maternal and child health knowledge, care-seeking, and practices. The quality assurance strategy aims to identify biases and other impediments to data quality and includes seven main components: (1) tool development, (2) enumerator recruitment and training, (3) field coordination, (4) field monitoring, (5) data analytics, (6) feedback loops for decision making, and (7) outcomes assessment. Analyses will include basic descriptive and outlier analyses using machine learning algorithms, which will involve creating features from time-stamps, “don’t know” rates, and skip rates. We will also obtain labeled data from self-filled surveys, and build models using k-folds cross-validation on a training data set using both supervised and unsupervised learning algorithms. Based on these models, results will be fed back to the field through various feedback loops. Results: Data collection began in late October 2019 and will span through March 2020. We expect to submit quality assurance results by August 2020. Conclusions: Machine learning is underutilized as a tool to improve survey data quality in low resource settings. Study findings are anticipated to improve the overall quality of Kilkari survey data and, in turn, enhance the robustness of the impact evaluation. More broadly, the proposed quality assurance approach has implications for data capture applications used for special surveys as well as in the routine collection of health information by health workers. Trial Registration:

  • DARIO Study Logo. Source: Preventive Oncology, DKFZ/NCT Heidelberg; Copyright: Preventive Oncology, DKFZ/NCT Heidelberg; License: The use is free of charge. The NCT (National Center for Tumor Disease Heidelberg) and DKFZ ( German Cancer Research Center) Heidelberg permit one-time use in connection with the manuscript on DARIO and the NCT/DKFZ Heidelberg. Passing on the picture material to third parties is only permitted after prior consultation with the NCT press office (Tel. +49-6221 56 5930, E-Mail: friederike.fellenberg@nct-heidelberg.de). Use for commercial purposes is prohibited..

    Effects of Alternative Offers of Screening Sigmoidoscopy and Colonoscopy on Utilization and Yield of Endoscopic Screening for Colorectal Neoplasms: Protocol...

    Abstract:

    Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Despite colonoscopy being offered for CRC screening in Germany, the uptake of this offer has been very limited. Objective: The objective of this study was to assess the potential for increasing use of endoscopic CRC screening and the detection of advanced colorectal neoplasms by offering the choice between use of flexible sigmoidoscopy and colonoscopy. Methods: The DARIO study includes a cross-sectional study (part I), followed by a prospective 2-arm randomized controlled intervention trial (part II) with an associated biobank study (part III). Participation is possible in part I of the DARIO study only, parts I and II, or all 3 study parts. After obtaining informed consent from the municipalities, 12,000 people, aged 50-54 years, from the Rhine-Neckar region in Germany were randomly selected from residential lists of the responsible population registries and invited to complete a standardized questionnaire to investigate the nature, frequency, timing, and results of previous CRC screening and eventual diagnostic colonoscopies. In study part II participants from study part I with no colonoscopy in the preceding 5 years are randomized into 2 arms: arm A offering screening colonoscopy only, and arm B offering both options, either screening colonoscopy or screening sigmoidoscopy. The primary endpoint is the proportion of participants in whom colorectal neoplasms >0.5 cm are detected and removed at screening endoscopy. The secondary endpoints are the detection rate of any neoplasm and use of any endoscopic screening. Part III of the study will use samples from participants in study part II to construct a liquid and tissue biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool, and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy. Results: A total of 10,568 from 12,000 randomly selected women and men aged 50-54 years living in the Rhine-Neckar-Region of Germany have been invited for participation. The remaining 1432 (11.93%) could not be invited because they reached the age of 55 at the time of contact. Of those invited, 2785/10,568 (26.35%) participated in study part I; 53.60% (1493/2785) of these participants were female. Study parts II and III are ongoing. Conclusions: This study will answer the question if alternative offers of either screening sigmoidoscopy or screening colonoscopy will increase utilization and effectiveness of endoscopic CRC screening compared with an exclusive offer of screening colonoscopy. In addition, alternative noninvasive screening tests will be developed and validated. Trial Registration: German Clinical Trials Register DRKS00018932; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00018932

  • Source: The Authors/Placeit; Copyright: The Authors/Placeit; URL: https://www.researchprotocols.org/2020/8/e17363; License: Creative Commons Attribution (CC-BY).

    Learning Integrated Health System to Mobilize Context-Adapted Knowledge With a Wiki Platform to Improve the Transitions of Frail Seniors From Hospitals and...

    Abstract:

    Background: Elderly patients discharged from hospital experience fragmented care, repeated and lengthy emergency department (ED) visits, relapse into their earlier condition, and rapid cognitive and functional decline. The Acute Care for Elders (ACE) program at Mount Sinai Hospital in Toronto, Canada uses innovative strategies, such as transition coaches, to improve the care transition experiences of frail elderly patients. The ACE program reduced the lengths of hospital stay and readmission for elderly patients, increased patient satisfaction, and saved the health care system over Can $4.2 million (US $2.6 million) in 2014. In 2016, a context-adapted ACE program was implemented at one hospital in the Centre intégré de santé et de services sociaux de Chaudière-Appalaches (CISSS-CA) with a focus on improving transitions between hospitals and the community. The quality improvement project used an intervention strategy based on iterative user-centered design prototyping and a “Wiki-suite” (free web-based database containing evidence-based knowledge tools) to engage multiple stakeholders. Objective: The objectives of this study are to (1) implement a context-adapted CISSS-CA ACE program in four hospitals in the CISSS-CA and measure its impact on patient-, caregiver-, clinical-, and hospital-level outcomes; (2) identify underlying mechanisms by which our context-adapted CISSS-CA ACE program improves care transitions for the elderly; and (3) identify underlying mechanisms by which the Wiki-suite contributes to context-adaptation and local uptake of knowledge tools. Methods: Objective 1 will involve staggered implementation of the context-adapted CISSS-CA ACE program across the four CISSS-CA sites and interrupted time series to measure the impact on hospital-, patient-, and caregiver-level outcomes. Objectives 2 and 3 will involve a parallel mixed-methods process evaluation study to understand the mechanisms by which our context-adapted CISSS-CA ACE program improves care transitions for the elderly and by which our Wiki-suite contributes to adaptation, implementation, and scaling up of geriatric knowledge tools. Results: Data collection started in January 2019. As of January 2020, we enrolled 1635 patients and 529 caregivers from the four participating hospitals. Data collection is projected to be completed in January 2022. Data analysis has not yet begun. Results are expected to be published in 2022. Expected results will be presented to different key internal stakeholders to better support the effort and resources deployed in the transition of seniors. Through key interventions focused on seniors, we are expecting to increase patient satisfaction and quality of care and reduce readmission and ED revisit. Conclusions: This study will provide evidence on effective knowledge translation strategies to adapt best practices to the local context in the transition of care for elderly people. The knowledge generated through this project will support future scale-up of the ACE program and our wiki methodology in other settings in Canada. Trial Registration: ClinicalTrials.gov NCT04093245; https://clinicaltrials.gov/ct2/show/NCT04093245.

  • Logo of the ¡Alégrate! program. Source: Becky Ponder -- Director of Communications at the University of Illinois at Urbana-Champaign School of Social Work; Copyright: University of Illinois at Urbana-Champaign; URL: https://www.researchprotocols.org/2020/7/e17721; License: The image is owned by the University of Illinois at Urbana-Champaign and the corresponding author..

    A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension:...

    Abstract:

    Background: Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. Objective: The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. Methods: A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. Results: Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. Conclusions: Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. Trial Registration: ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/close-up-doctor-filling-medical-form-with-patient_3894250.htm#page=1&query=patient%20form&position=6; License: Licensed by JMIR.

    An Evaluation of Parents’ Experiences of Patient Engagement in Research to Develop a Digital Knowledge Translation Tool: Protocol for a Multi-Method Study

    Abstract:

    Background: The last decade has seen increasing calls for patient and public involvement in health-related research due to an ideological shift toward more equitable methods of knowledge development and an effort to increase the usability and relevance of knowledge by improving outcomes in clinical practice. Patient engagement includes simply informing patients to offering complete decision-making autonomy to individuals, groups, communities, caregivers, friends, and families who have personal experience and knowledge of a health issue. Despite the use of patient engagement methods in research, evaluation has lagged, resulting in a knowledge gap that makes it difficult to foster capacity and sustainability for patients and researchers alike since little is known about how effective patient collaborations in research are built, maintained, or improved. This study centers on pediatric functional constipation, a common condition that affects children and families. Since parents play a pivotal role in treatment, they are an optimal group to engage in improving the resources and support available to them. Objective: This study aims to use patient-engagement methods to establish a research collaboration with parents to cocreate a digital knowledge translation tool for parents caring for a child with functional constipation and formally evaluate the patient engagement processes within this project to build the science of patient engagement in research. Methods: Members of the parent collaborator group will be recruited from previous participants who expressed interest in the development of a digital knowledge translation tool. The group will collaborate with the research team to create a tool to address patients’ support and information needs when caring for a child with functional constipation. The parent collaborator group will then be evaluated in a multimethod study design. Data will be digitally and anonymously collected from all members of the parent collaborator group, using the validated Public and Patient Engagement Evaluation Tool (PPEET) patient questionnaire. Descriptive statistics will be used to report group characteristics and question responses. Qualitative analysis will be used to understand open-ended question responses. Specifically, directed content analysis will be used to assess themes of the Patient Engagement in Research (PEIR) Framework with a combination of deductive and inductive analyses. Findings will be integrated into the discussion if there are sufficient commonalities and inter-relationships. The final manuscript will include reporting of each element as described by the Good Reporting of a Mixed Methods Study criteria. Results: Recruitment is planned for June 2020. Data collection for the evaluation of patient engagement processes will occur upon completion of the digital knowledge translation tool. The results of this study are expected to be published by the end of 2020. Conclusions: This study will provide valuable information about parents’ experiences participating in child-health research and is a fundamental step in building the science of patient engagement in research.

  • Source: freepik; Copyright: pressfoto; URL: https://www.freepik.com/free-photo/texting-with-colleague-smartphone_5633466.htm#page=1&query=student%20using%20phone&position=31; License: Licensed by JMIR.

    Usability Methods and Attributes Reported in Usability Studies of Mobile Apps for Health Care Education: Protocol for a Scoping Review

    Abstract:

    Background: E-learning technologies, including mobile apps, are used to a large extent in health care education. Mobile apps can provide extendable learning environments and motivate students for adaptive and collaborative learning outside the classroom context. Developers should design practical, effective, and easy-to-use mobile apps. Usability testing is an important part of app development in order to understand if apps meet the needs of users. Objective: The aim of this study is to perform a scoping review of usability methods and attributes reported in usability studies of mobile apps for health care education. Methods: The scoping review is guided by the methodological framework developed by Arksey & O’Malley and further developed by Levac et al and Kahlil et al. The stages we will follow are as follows: (1) identifying the research question; (2) identifying relevant studies; (3) selecting studies; (4) charting the data; and (5) summarizing and reporting the results. We have developed two research questions to meet the aim of the study, which are as follows: (1) What usability methods are used to evaluate the usability of mobile apps for health care education? and (2) What usability attributes are reported in the usability studies of mobile apps for health care education? We will apply a comprehensive search of the literature, including 10 databases, a reference search, and a search for grey literature. Two review authors will independently screen articles for eligibility. Results: The initial electronic database searches were completed in March 2019. The literature search identified 14,297 unique references. Following title and abstract screening, the full texts of 369 records were obtained. The scoping review is expected to be completed in spring 2021. Conclusions: We expect the overview of usability methods and attributes reported in usability studies of mobile apps for health care education to contribute to the knowledge base for researchers and developers. It will give an overview of the research field and provide researchers and developers with relevant and important information on the usability research area, including highlighting possible research gaps.

  • Source: The Authors/Placeit; Copyright: The Authors/Placeit; URL: http://www.researchprotocols.org/2020/8/e18578/; License: Licensed by the authors.

    Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized...

    Abstract:

    Background: Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. Many of these costs are related to poor medication adherence and lack of self-care behaviors and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up. Objective: This study aims to examine the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed type 2 diabetes and elevated levels of depression. Methods: This is a randomized controlled trial in which adults with a type 2 diabetes diagnosis, elevated hemoglobin A1c (HbA1c) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation skills intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3, 6, and 12 months postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA1c, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. Results: Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. Conclusions: Although previous research suggests that in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the effects of a digital mental health intervention among adults with type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. Trial Registration: ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805.

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  • Complementary and alternate therapies (CAM) in the management of novel Corona virus (COVID-19): protocol for systematic review and meta-analysis

    Date Submitted: Aug 2, 2020

    Open Peer Review Period: Aug 2, 2020 - Sep 27, 2020

    Background: In December 2019, a new coronavirus (COVID19) infected pneumonia broke out in the Chinese province of Wuhan. With the nature of the spread around the word, it has been announced as pandemi...

    Background: In December 2019, a new coronavirus (COVID19) infected pneumonia broke out in the Chinese province of Wuhan. With the nature of the spread around the word, it has been announced as pandemic and many complementary and alternative therapies (CAM) are being tried along with conventional approaches for the effective management of COVID 19. Objective: This paper presents the protocol for the systematic review and meta-analysis of the studies using various CAM therapies for the management of COVID19 pneumonia. Methods: Electronic databases such as PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) will be used for the searching the relevant trials and studies with keywords related to COVID-19 and CAM therapies. Two independent reviewers will screen all the list of the trials and extract the relevant variables. Additionally, we will also evaluate the risk of bias of the selected studies. Results: Review Manager software (RevMan; version 5.3.5) and R statistical software (version 3.6.1) will be used for the data analysis. Risk ratio (RR) would be estimated for dichotomous outcomes and the mean differences (MD) would be measured for continuous outcomes. Heterogeneity with the help of I2 statistic will be used for the assessment of inconsistency across studies with the level of significance at P< 0.10. We would also assess publication bias using funnel plots, Egger’s test and Begg’s test for the selected studies. Conclusions: The protocol for the systematic review and meta-analysis would investigate the preventive and treatment effects of various CAM therapies for COVID-19 associated pneumonia and also assess the benefits and harms of the CAM therapies in the COVID-19 management. Clinical Trial: Systematic review registration: PROSPERO registration number- CRD42020187532

  • Protocol: Impact of Nutrition Education on Nutrition Capacity of Caregivers and Nutrition Outcomes of Indigenous Mbororo Children in the West Region of Cameroon: Cluster Randomized Controlled Trial

    Date Submitted: Aug 1, 2020

    Open Peer Review Period: Aug 1, 2020 - Sep 26, 2020

    Background: Inadequate diets and life-threatening infections have profound adverse implications for child growth, development and survival, particularly among marginalized populations. Evidence of the...

    Background: Inadequate diets and life-threatening infections have profound adverse implications for child growth, development and survival, particularly among marginalized populations. Evidence of the effectiveness of community-based nutrition education interventions in improving child feeding and nutrition outcomes among Indigenous Mbororo population in Cameroon is scare. Objective: This study aims at investigating the impact of culturally-tailored community-based nutrition education intervention (Nu-WASHE) on caregivers’ knowledge attitude and practice (KAP) regarding complementary feeding and nutrition outcomes of Indigenous Mbororo children (3-59 months) in the Foumban and Galim health districts of the West region of Cameroon. Methods: A two-arm cluster randomized controlled trial will be conducted in the Foumban health district (FHD) and Galim health district (GHD). The intervention and control arms will each comprise of 5 clusters with 121 child-caregiver pairs. The intervention will consist of twelve 90 to 120 minutes facilitated group sessions, using 5 caregivers’ peer-support platforms. Six trained female Mbororo nutrition volunteers resident in the communities and 6 community health workers will lead the intervention under supervision. The control arm will receive routine facility-based nutrition education. Data will be collected at 3 months and 6 months follow-up. Both descriptive statistics and multivariate logistic models will be used to estimate the effect of Nu-WASHE (independent variable) on outcome variables (complementary feeding KAP, child’s weight, height/length, and morbidity status) within and between both arms. Clustering effect will be considered in the analysis. An approval (ref: 2019/1002-07/UB/SG/IRB/FHS) was obtained from the Faculty of Health Sciences-Institutional Review Board of the University of Buea. Results: From the pre-intervention study undertaken in September 2019, baseline data was collected and partially analyzed to inform the design of this proposed experimental study. In February 2020, 10 Mbororo communities (clusters) with 242 child-caregiver pairs were selected for the trial. Six community nutrition volunteers (CNV) and 6 community health workers (CHW) were selected and trained. Due to the COVID-19 preventive measures, implementation of the trial could not effectively start in March 2020 as scheduled. Conclusions: The findings of this study will provide evidence on the impact of culturally-tailored and Health belief Model-based nutrition education for behavior change as a complementary strategy for strengthening health facility-based approaches to the burden of malnutrition among the study population. Clinical Trial: The protocol was submitted to the WHO Pan Africa Clinical Trial Registry in South Africa for review. Feedback is still being awaited. The last correspondence was on July 4, 2020

  • Operating Room Instruction for COVID-19 Epidemic: A Meta-Synthesis

    Date Submitted: Aug 1, 2020

    Open Peer Review Period: Aug 1, 2020 - Sep 26, 2020

    Background: COVID-19crisis changes the patients' treatment procedures worldwide. Preventive procedures should be developed for COVID-19 in order to prevent its development, managethis epidemic properl...

    Background: COVID-19crisis changes the patients' treatment procedures worldwide. Preventive procedures should be developed for COVID-19 in order to prevent its development, managethis epidemic properly, and provide safe and effective service. Operating room is aplace where it is important to follow the instructions to cope with this disease because the operating room staffsare at the highest risk of infection with COVID-19. The present study aimed to design instructions for behavior in the operating room during the COVID-19 epidemic. Objective: The present study aimed to design instructions for behavior in the operating room during the COVID-19 epidemic. Methods: The present study was conducted by a systematic review method. Searching was performed by keywords COVID-19, surgery, operating room, anesthesia, and instructions on PUBMED, Science Direct, Ovid, and ProQuest databases; and 98 studied were obtained. It decreased to 42 items after repeating the duplicate items and reviewing the summary of articles, and finally 23 studies were selected for review. First, the articles were reviewed based on the titles and summary, and if they were included in the study if they had the inclusion criteria. The inclusion criteria were English and Persian languages; the relevance of articles on COVID-19, surgery and anesthesia. Results: : Patients should be screened for COVID-19 for surgery, and caution should be exercised if they had ear, nose and throat, jaw and face, head and neck surgeries. Intubation is one of the most risky activities that need to be done with full caution. Chlorine for the surface and equipment, and Ultraviolet (UV) for operating rooms are now the most accessible and effective disinfectants. Conclusions: Following the operating instructions in the operating room prevented the transmission of COVID among patients and staff and helped to perform safe surgery during the COVID-19 epidemic. Clinical Trial: -

  • A Randomized Controlled Trial (RCT) to evaluate the role of a AI based personalized smartphone application to improve childhood Immunization coverage and timelines among children in Pakistan: Protocol for a mixed-methods study

    Date Submitted: Jul 29, 2020

    Open Peer Review Period: Jul 29, 2020 - Sep 23, 2020

    Background: The immunization uptake rates in Pakistan are much lower than desired. Major reasons include lack of awareness, parental forgetfulness regarding schedules, and misinformation regarding vac...

    Background: The immunization uptake rates in Pakistan are much lower than desired. Major reasons include lack of awareness, parental forgetfulness regarding schedules, and misinformation regarding vaccines. In light of current pandemic and distancing measures, the Childhood Routine Immunization (CRI) coverage is adversely affected as caregivers avoid tertiary care hospitals or primary health centers. Innovative and cost-effective measures need to be taken to understand and address the causes of low immunization rates. However, only a few smartphone-based interventions have been carried out in LMICs to improve CRI. Objective: The primary objectives of this study are to evaluate whether a personalized mobile application can improve on-time visits at 10 and 14 weeks of age for CRI as compared with standard care. Secondly, whether Artificial intelligence (AI) model can be incorporated into the application. Secondary objectives are to learn the perception and attitudes of caregivers regarding childhood vaccination and understand the factors that might influence mobile phone-based application for vaccination improvement. Methods: A mixed-methods randomized controlled trial with an intervention and control arm. The study will be conducted at the AKUH vaccination center. Caregivers of the newborns (NB) or infants visiting for 6-week vaccination will be recruited. The intervention arm will be subjected to a smartphone application with text, voice, video, and pictorial messages regarding CRI. This application will be developed based on the findings of the pretrial qualitative component of the study, in addition to ‘no show’ study findings[1], exploring Caregivers Perceptions about CRI and Mobile Phone-based application in improving the CRI Coverage. Results: Pretrial qualitative IDIs were conducted in February 2020. The enrollment of the study participants for the randomized control trial is in process. Study exit interviews will be conducted at 14-week immunization visit if the caregivers visit the immunization facility or over the phone at 18 weeks of child’s age. Conclusions: This study will generate useful insights into the feasibility, acceptability, and usability of an AI based smartphone application for improving CRI in Pakistan and LMICs. Clinical Trial: ClinicalTrials.gov NCT04449107; https://clinicaltrials.gov/ct2/show/NCT04449107

  • Pulse Discovery Toolkit: Protocol for a multi-component nutrition intervention developed using an intervention mapping approach to promote the consumption of pulse-based foods in childcare centers

    Date Submitted: Jul 24, 2020

    Open Peer Review Period: Jul 24, 2020 - Sep 18, 2020

    Background: Plant-based foods, including pulses (dry beans, lentils, chickpeas, and peas), have gained worldwide attention due to their health and environmental benefits. Despite high productions, the...

    Background: Plant-based foods, including pulses (dry beans, lentils, chickpeas, and peas), have gained worldwide attention due to their health and environmental benefits. Despite high productions, the consumption of pulses is low in Canada. Behavior change interventions systematically designed to promote the consumption of pulse-based foods are scarce. Objective: This protocol describes a multi-component nutrition intervention developed using an intervention mapping approach to promote the consumption of pulse-based foods among pre-school children in childcare centers in Saskatchewan. Methods: The intervention, Pulse Discovery Tool Kit, was developed following the six steps of the intervention mapping (IM) protocol. Decisions at each step were either based upon a literature review, expert consultation, pre-testing, or a combination of these. Following the initial phase of the study, which focused on intervention development, Phase II and Phase III of the study were concerned with pilot testing and roll-out of the intervention, respectively. In total, n=1, n=2 and n=4 childcare centers participated in Phase I, II and III, respectively. A multi-method approach was designed to evaluate the intervention during pilot-testing and roll-out. Results: The application of IM Steps 1-3 in Phase I resulted in the creation of performance objectives at different levels, including at the individual level (preschool child), and the social and environmental level (parents, early childhood educator and cook). These objectives were then used to create a matrix of objectives matching the constructs of the Social Cognitive Theory while taking Piaget’s cognitive development into consideration. This step was followed by defining program components, implementation, adoption, and evaluation strategies, which were implemented in Phase II and III. Conclusions: The intervention mapping protocol provided a rigorous framework for the development of a multi-component evidence-based intervention to promote pulse-based foods in childcare centers. Clinical Trial: NA

  • Novel Assessments of Technical and Non-Technical Cardiac Surgery Quality: Protocol for a Mixed Methods Study

    Date Submitted: Jul 22, 2020

    Open Peer Review Period: Jul 22, 2020 - Sep 16, 2020

    Background: Of the 150,000 patients annually undergoing coronary artery bypass grafting surgery, 35% develop complications that increase mortality 5-fold and expenditures by 50%. Differences in patien...

    Background: Of the 150,000 patients annually undergoing coronary artery bypass grafting surgery, 35% develop complications that increase mortality 5-fold and expenditures by 50%. Differences in patient risk and operative approach explain only 2% of hospital variation in some complications. The intraoperative phase remains understudied as a source of variation, despite its complexity and amenability to improvement. Objective: The objectives of this study are to: (i) investigate the relationship between peer assessments of intraoperative technical skills and non-technical practices with risk-adjusted complication rates and (ii) evaluate the feasibility of using computer-based metrics to automate the assessment of important intraoperative technical skills and non-technical practices. Methods: This multi-center study will use video-recording, established peer assessment tools, electronic health record data, registry data and a high-dimensional computer vision approach to: (1) investigate the relationship between peer assessments of surgeon technical skills and variability in risk-adjusted patient adverse events; (2) investigate the relationship between peer assessments of intraoperative team-based non-technical practices and variability in risk-adjusted patient adverse events; (3) use quantitative and qualitative methods to explore the feasibility of using objective, data-driven computer-based assessments to automate the measurement of significant, intraoperative determinants of risk-adjusted patient adverse events. Results: The project was funded by the National Heart, Lung and Blood Institute in 2019 and enrollment for the overall project is expected to begin in 2020. Conclusions: We anticipate this project will substantially increase our ability to assess determinants of variation in complication rates by specifically studying a surgeon’s technical skills and operating room team member non-technical practices. These findings may provide effective targets for future trials or quality improvement initiatives to enhance the quality and safety of cardiac surgical patient care. Clinical Trial: -

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