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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:

  • Photo from fieldwork in Burkina Faso. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e17138/; License: Creative Commons Attribution (CC-BY).

    Investigating Health Impacts of Natural Resource Extraction Projects in Burkina Faso, Ghana, Mozambique, and Tanzania: Protocol for a Mixed Methods Study

    Abstract:

    Background: Natural resource extraction projects offer both opportunities and risks for sustainable development and health in host communities. Often, however, the health of the community suffers. Health impact assessment (HIA) can mitigate the risks and promote the benefits of development but is not routinely done in the developing regions that could benefit the most. Objective: Our study aims to investigate health and health determinants in regions affected by extractive industries in Burkina Faso, Ghana, Mozambique, and Tanzania. The evidence generated in our study will inform a policy dialogue on how HIA can be promoted as a regulatory approach as part of the larger research initiative called the HIA4SD (Health impact assessment for sustainable development) project. Methods: The study is a concurrent triangulation, mixed methods, multi-stage, multi-focus project that specifically addresses the topics of governance and policy, social determinants of health, health economics, health systems, maternal and child health, morbidity and mortality, and environmental determinants, as well as the associated health outcomes in natural resource extraction project settings across four countries. To investigate each of these health topics, the project will (1) use existing population-level databases to quantify incidence of disease and other health outcomes and determinants over time using time series analysis; (2) conduct two quantitative surveys on mortality and cost of disease in producer regions; and (3) collect primary qualitative data using focus groups and key informant interviews describing community perceptions of the impacts of extraction projects on health and partnership arrangements between the projects and local and national governance. Differences in health outcomes and health determinants between districts with and without an extraction project will be analyzed using matched geographical analyses in quasi-Poisson regression models and binomial regression models. Costs to the health system and to the households from diseases found to be associated with projects in each country will be estimated retrospectively. Results: Fieldwork for the study began in February 2019 and concluded in February 2020. At the time of submission, qualitative data collection had been completed in all four study countries. In Burkina Faso, 36 focus group discussions and 74 key informant interviews were conducted in three sites. In Ghana, 34 focus group discussions and 64 key informant interviews were conducted in three sites. In Mozambique, 75 focus group discussions and 103 key informant interviews were conducted in four sites. In Tanzania, 36 focus group discussions and 84 key informant interviews were conducted in three sites. Quantitative data extraction and collection is ongoing in all four study countries. Ethical approval for the study was received in all four study countries prior to beginning the fieldwork. Data analyses are underway and results are expected to be published in 2020 and 2021. Conclusions: Disentangling the complex interactions of resource extraction projects with their host communities requires an integrative approach drawing on many methodologies under the HIA umbrella. By using complementary data sources to address the question of population health in project areas from several angles, bias and missing data will be reduced, generating high-quality evidence to aid countries in moving toward sustainable development.

  • Source: The Authors/Placeit; Copyright: The Authors/Placeit; URL: https://www.researchprotocols.org/2020/4/e16664; License: Licensed by JMIR.

    Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody–Associated Vasculitis...

    Abstract:

    Background: Antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis is a serious, often life-threatening disease. In new-onset disease or a relapse, the standard treatment is immunosuppressive therapy with glucocorticoids; these therapies are associated with substantial short- and long-term toxicity. Complement component 5a (C5a) binding to C5a receptor (C5aR) may play a central role in the pathogenesis of ANCA-associated vasculitis. Avacopan is a novel, orally bioavailable, and highly selective antagonist of human C5aR. Avacopan does not interfere with the production of C5b or the membrane attack complex (ie, terminal complement complex) and does not block C5a binding to a second receptor, C5L2 (also called C5aR2), shown to be protective in antimyeloperoxidase glomerulonephritis. This trial will evaluate if avacopan replaces the need for chronic glucocorticoids in the treatment of ANCA-associated vasculitis. Objective: The aim of this study is to determine the proportions of patients in remission at week 26 and with sustained remission at week 52, defined as Birmingham Vasculitis Activity Score=0, and not taking glucocorticoids within the 4 weeks before week 26 and week 52, respectively. Methods: The Avacopan Development in Vasculitis to Obtain Corticosteroid elimination and Therapeutic Efficacy study is a randomized, double-blind, active-comparator (prednisone), 2-arm study evaluating the safety and efficacy of avacopan versus prednisone, administered in combination with other immunosuppressive therapy. Eligible subjects will have active disease requiring induction of remission. Subjects are stratified based on the type of immunosuppressive therapy, ANCA subtype, and new or relapsing disease. Target sample size is 300 patients, enrolled at over 200 sites globally. All authors and local ethics committees approved the study design. All patients will provide informed consent. Results: Enrollment of patients was completed in Q4 2018. Topline results are anticipated to be published by Q3 2020. Conclusions: Results will be released irrespective of whether the findings are positive or negative. Trial Registration: ClinicalTrials.gov NCT02994927; https://clinicaltrials.gov/ct2/show/NCT02994927

  • Guide character in SPARX Japanese version. Source: HIKARI Lab, Inc; Copyright: HIKARI Lab, Inc; URL: http://www.researchprotocols.org/2020/4/e15164/; License: Licensed by the authors.

    Gamified Mobile Computerized Cognitive Behavioral Therapy for Japanese University Students With Depressive Symptoms: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Evidence shows that computerized self-help interventions are effective for reducing symptoms of depression. One such intervention, SPARX, is a gamified mobile computerized cognitive behavioral therapy (cCBT) developed for adolescents in New Zealand, which was shown to be as effective as usual care for young people with mild-to-moderate symptoms of depression. However, gamified cCBT has not yet been tested in Japan. Objective: This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild-to-moderate depressive symptoms. Methods: In this 7-week, multicenter, stratified, parallel-group, superiority randomized trial, participants will be allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is a fully automated program, which will be delivered to the mobile phone or tablet device of the participants. SPARX is designed as an interactive fantasy game to guide the user through seven modules that teach key CBT strategies. All participants will be recruited from universities via advertisements on online bulletin boards, the campus newspaper, and posters. Participants in the treatment condition will use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using Patient Health Questionnaires-9) measured at baseline and weekly: once after the 7-week intervention and once at a 1-month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life, measured by the Satisfaction With Life Scale; positive and negative moods, measured by the Profile of Mood States Second Edition; social functioning, measured by the EuroQol Instrument; rumination, measured by the Ruminative Responses Scale; and coping, measured by the Brief Coping Orientation to Problem Experienced Inventory. Results: This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019. Conclusions: Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX with Japanese university students. Trial Registration: Japan Primary Registries Network UMIN000034354; https://tinyurl.com/uu7xd77

  • Source: Freepik; Copyright: peoplecreations; URL: https://www.freepik.com/free-photo/surgeons-performing-operation-operation-room_1008449.htm; License: Licensed by JMIR.

    Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

    Abstract:

    Background: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. Objective: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. Methods: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. Results: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. Conclusions: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval.

  • Source: Obesity Action Coalition; Copyright: Obesity Action Coalition; URL: https://www.obesityaction.org/gallery/business-professional/?paged=15; License: Licensed by the authors.

    Effectiveness of Gastric Bypass Versus Gastric Sleeve for Cardiovascular Disease: Protocol and Baseline Results for a Comparative Effectiveness Study

    Abstract:

    Background: When compared with conventional weight loss strategies, bariatric surgery results in substantially greater durable weight loss and rates of disease remission. Objective: The ENGAGE CVD (Effectiveness of Gastric Bypass versus Gastric Sleeve for Cardiovascular Disease) cohort study aimed to provide population-based, comprehensive, rigorous evidence for clinical and policy decision making regarding the choice between gastric bypass and gastric sleeve for overall cardiovascular disease (CVD) risk reduction, risk factor remission, and safety. Methods: The cohort had 22,095 weight loss surgery patients from a large integrated health care system in Southern California assembled from 2009 to 2016 who were followed up through 2018. Bariatric surgery patients were followed up for the length of their membership in the health care system. Of the patients who had at least five years of follow-up (surgery between 2009 and 2013), 85.86% (13,774/16,043) could contribute to the outcome analyses for the ENGAGE CVD cohort. Results: Patients in the ENGAGE CVD cohort were 44.6 (SD 11.4) years old, mostly women (17,718/22,095; 80.19%), with 18.94% (4185/22,095) non-Hispanic black and 41.80% (9235/22,095) Hispanic, and had an average BMI of 44.3 (SD 6.9) kg/m2 at the time of surgery. When compared with patients who did not contribute data to the 5-year outcome analysis for the ENGAGE CVD cohort (2269/16,043; 14.14%), patients who contributed data (13,774/16,043; 85.86%) were older (P=.002), more likely to be women (P=.02), more likely to be non-Hispanic white (P<.001), more likely to have had an emergency department visit in the year before surgery (P=.006), less likely to have a mental illness before surgery (P<.001), and more likely to have had a CVD event at any time before surgery (P<.001). Conclusions: This study had one of the largest populations of gastric sleeve patients (n=13,459). The 5-year follow-up for those patients who had surgery between 2009 and 2013 was excellent for a retrospective cohort study at 85.86% (13,774/16,043). Unlike almost any study in the literature, the majority of the ENGAGE CVD cohort was racial and ethnic minority, providing a rare opportunity to study the effects of bariatric surgery for different racial and ethnic groups, some of whom have the highest rates of severe obesity in the United States. Finally, it also used state-of-the-art statistical and econometric comparative effectiveness methods to mimic the effect of random assignment and control for sources of confounding inherent in large observational studies.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e16474/; License: Fair use/fair dealings.

    Promoting Wellness Through Mobile Health Technology in a College Student Population: Protocol Development and Pilot Study

    Abstract:

    Background: The health and well-being of college students has garnered widespread attention and concern in recent years. At the same time, the expansion and evaluation of digital technologies has grown in recent years for different target populations. Objective: This protocol aims to describe a pilot feasibility study on wearables to assess student interest and to gather baseline data from college freshmen, for the academic year 2019 to 2020. Methods: All full-time college freshmen residing in a single residence hall were eligible to participate. Study invitations were sent by post and email 5 weeks prior to move-in. Web-based enrollment and in-person attendance at study orientation sessions were mandatory. We provided the incoming freshmen with a wearable and study app. Wearable data and weekly survey data will be collected through the study app and analyzed. We have collected demographic, enrollment, and attrition data and the number and type of support requests from students. Results: The planning phase of the WearDuke initiative was completed in 2018 to 2019, and the pilot study was launched in July 2019. Of the 175 students invited, 120 enrolled and 114 started the study; 107 students remained active participants till the end of the fall semester. For Apple Watch participants (the majority of study population), weekly survey completion rates ranged from 70% (74/106) to 96% (95/99). Conclusions: Halfway through the pilot, we noticed that the initiative has been received positively by the students with minimal attrition. The short- and long-term benefits may be substantial for students, the campus, the utilization of health services, and long-term health.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e16641/; License: Creative Commons Attribution (CC-BY).

    User Experience and Potential Health Effects of a Conversational Agent-Based Electronic Health Intervention: Protocol for an Observational Cohort Study

    Abstract:

    Background: While the average human life expectancy has increased remarkably, the length of life with chronic conditions has also increased. To limit the occurrence of chronic conditions and comorbidities, it is important to adopt a healthy lifestyle. Within the European project “Council of Coaches,” a personalized coaching platform was developed that supports developing and maintaining a healthy lifestyle. Objective: The primary aim of this study is to assess the user experience with and the use and potential health effects of a fully working Council of Coaches system implemented in a real-world setting among the target population, specifically older adults or adults with type 2 diabetes mellitus or chronic pain. Methods: An observational cohort study with a pretest-posttest design will be conducted. The study population will be a dynamic cohort consisting of older adults, aged ≥55 years, as well as adults aged ≥18 years with type 2 diabetes mellitus or chronic pain. Each participant will interact in a fully automated manner with Council of Coaches for 5 to 9 weeks. The primary outcomes are user experience, use of the program, and potential effects (health-related factors). Secondary outcomes include demographics, applicability of the virtual coaches, and user interaction with the virtual coaches. Results: Recruitment started in December 2019 and is conducted through mass mailing, snowball sampling, and advertisements in newspapers and social media. This study is expected to conclude in August 2020. Conclusions: The results of this study will either confirm or reject the hypothesis that a group of virtual embodied conversational coaches can keep users engaged over several weeks of interaction and contribute to positive health outcomes. Trial Registration: The Netherlands Trial Register: NL7911; https://www.trialregister.nl/trial/7911

  • Source: Freepik; Copyright: katemangostar; URL: https://www.freepik.com/free-photo/serious-young-businessman-opening-letter-cafe_1473452.htm#page=1&query=opening%20a%20letter&position=14; License: Licensed by JMIR.

    Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Fecal occult blood testing has been offered for many years in the German health care system, but participation rates have been notoriously low. Objective: The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in persons aged 50-54 years. Methods: This study consists of a three-armed randomized controlled trial: (1) arm A: an invitation letter from a health insurance plan including a FIT test kit, (2) arm B: an invitation letter from a health insurance plan including an offer to receive a free FIT test kit by mail upon easy-to-handle request (ie, by internet, fax, or reply mail), and (3) arm C: an information letter on an existing colonoscopy offer (ie, control). Within arms A and B, a random selection of 50% of the study population will receive reminder letters, the effects of which are to be evaluated in a substudy. Results: A total of 17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany—AOK Baden-Wuerttemberg—were sent an initial invitation, and 5825 reminder letters were sent out. The primary end point is FIT usage within 1 year from receipt of invitation or information letter. The main secondary end points include gender-specific FIT usage within 1 year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms. The study was launched in September 2017. Data collection and workup were completed in fall 2019. Conclusions: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. Trial Registration: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt

  • Mother completing information giving and consent process with her child. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e16531/; License: Creative Commons Attribution (CC-BY).

    Determining the Agreement Between an Automated Respiratory Rate Counter and a Reference Standard for Detecting Symptoms of Pneumonia in Children: Protocol...

    Abstract:

    Background: Acute respiratory infections (ARIs), primarily pneumonia, are the leading infectious cause of under-5 mortality worldwide. Manually counting respiratory rate (RR) for 60 seconds using an ARI timer is commonly practiced by community health workers to detect fast breathing, an important sign of pneumonia. However, correctly counting breaths manually and classifying the RR is challenging, often leading to inappropriate treatment. A potential solution is to introduce RR counters, which count and classify RR automatically. Objective: This study aims to determine how the RR count of an Automated Respiratory Infection Diagnostic Aid (ARIDA) agrees with the count of an expert panel of pediatricians counting RR by reviewing a video of the child’s chest for 60 seconds (reference standard), for children aged younger than 5 years with cough and/or difficult breathing. Methods: A cross-sectional study aiming to enroll 290 children aged 0 to 59 months presenting to pediatric in- and outpatient departments at a teaching hospital in Addis Ababa, Ethiopia, was conducted. Enrollment occurred between April and May 2017. Once enrolled, children participated in at least one of three types of RR evaluations: (1) agreement—measure the RR count of an ARIDA in comparison with the reference standard, (2) consistency—measure the agreement between two ARIDA devices strapped to one child, and (3) RR fluctuation—measure RR count variability over time after ARIDA attachment as measured by a manual count. The agreement and consistency of expert clinicians (ECs) counting RR for the same child with the Mark 2 ARI timer for 60 seconds was also measured in comparison with the reference standard. Results: Primary outcomes were (1) mean difference between the ARIDA and reference standard RR count (agreement) and (2) mean difference between RR counts obtained by two ARIDA devices started simultaneously (consistency). Conclusions: Study strengths included the design allowing for comparison between both ARIDA and the EC with the reference standard RR count. A limitation is that exactly the same set of breaths were not compared between ARIDA and the reference standard since ARIDA can take longer than 60 seconds to count RR. Also, manual RR counting, even when aided by a video of the child’s chest movements, is subject to human error and can result in low interrater reliability. Further work is needed to reach global consensus on the most appropriate reference standard and an acceptable level of agreement to provide ministries of health with evidence to make an informed decision on whether to scale up new automated RR counters. Trial Registration: ClinicalTrials.gov NCT03067558; https://clinicaltrials.gov/ct2/show/NCT03067558

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/close-up-old-couple-with-smartphone_5125304.htm; License: Licensed by JMIR.

    A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility...

    Abstract:

    Background: This proposed study aims to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC), a classroom-based, antihypertensive, dietary educational intervention, to an innovative smartphone app (mDASHNa-CC). This study will enable Chinese Canadian seniors to access antihypertensive dietary interventions anytime, regardless of where they are. It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. Objective: The goal of this study is to design and test the usability and feasibility of a smartphone-based dietary educational app to support a healthy diet and hypertension control for Chinese Canadian seniors. Methods: A mixed-method two-phase design will be used. The study will be conducted in a Chinese immigrant community in Toronto, Ontario, Canada. Chinese Canadian seniors, who are at least 65 years old, self-identified as Chinese, living in Canada, and with elevated blood pressure, will be recruited. In Phase I, we will design and test the usability of the app using a user-centered approach. In Phase II, we will test the feasibility of the app, including implementation (primary outcomes of accrual and attrition rates, technical issues, acceptability of the app, and adherence to the intervention) and preliminary effectiveness (secondary outcomes of systolic and diastolic blood pressure, weight, waist circumference, health-related quality of life, and health service utilization), using a pilot, two-group, randomized controlled trial with a sample size of 60 participants in a Chinese Canadian community. Results: The study is supported by the Startup Research Grant from Nipissing University, Canada. The research ethics application is under review by a university research ethics review board. Conclusions: The study results will make several contributions to the existing literature, including illustrating the rigorous design and testing of smartphone app technology for hypertension self-management in the community, exploring an approach to incorporating traditional medicine into chronic illness management in minority communities and promoting equal access to current technology among minority immigrant senior groups. Trial Registration: Clinicaltrials.gov NCT03988894; https://clinicaltrials.gov/ct2/show/NCT03988894

  • Urine tenofovir point-of-care test. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2020/4/e15029; License: Creative Commons Attribution (CC-BY).

    Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot...

    Abstract:

    Background: The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. Objective: The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. Methods: The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. Results: This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. Conclusions: A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. Trial Registration: ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464

  • Source: Iijima M; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e17117/; License: Creative Commons Attribution (CC-BY).

    Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled...

    Abstract:

    Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated peripheral neuropathy that is currently classified into several clinical subtypes, which are presumed to have different pathogenic mechanisms. Recently, studies identified a subgroup of patients with CIDP who were positive for IgG4 autoantibodies against paranodal proteins, such as neurofascin-155 and contactin-1, who respond poorly to first-line therapies for typical CIDP, including intravenous immunoglobulin therapy. Objective: This study aims to evaluate the efficacy and safety of intravenous rituximab according to IgG4 autoantibody status in patients with refractory CIDP. Methods: The Evaluation of the Efficacy and Safety of Rituximab in Refractory CIDP Patients with IgG4 Autoantibodies in the Exploratory Clinical (RECIPE) trial consists of 2 cohorts: a multicenter, placebo-controlled, randomized study cohort of 15 patients with IgG4 autoantibody-positive CIDP (rituximab:placebo = 2:1) and an open-label trial cohort of 10 patients with antibody-negative CIDP. The primary endpoint is improvement in functional outcome assessed using the adjusted Inflammatory Neuropathy Cause and Treatment Disability Scale score at 26, 38, or 52 weeks after the start of treatment with rituximab in patients with CIDP and anti-paranodal protein antibodies. Secondary outcome measures include grip strength, manual muscle testing sum scores, results of nerve conduction studies, and other functional scales. Results: We plan to enroll 25 cases for the full analysis set. Recruitment is ongoing, with 14 patients enrolled as of January 2020. Enrollment will close in September 2020, and the study is planned to end in December 2021. Conclusions: This randomized controlled trial will determine if rituximab is safe and effective in patients with anti-paranodal antibodies. An open-label study will provide additional data on the effects of rituximab in patients with antibody-negative CIDP. The results of the RECIPE trial are expected to provide evidence for the positioning of rituximab as a pathogenesis-based therapeutic for refractory CIDP. Trial Registration: ClinicalTrials.gov NCT03864185, https://clinicaltrials.gov/ct2/show/NCT03864185 ; The Japan Registry of Clinical Trials jRCT2041180037, https://jrct.niph.go.jp/en-latest-detail/jRCT2041180037

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    Date Submitted: Apr 3, 2020

    Open Peer Review Period: Apr 2, 2020 - May 28, 2020

    Background: E-learning technology, including mobile applications (apps), is used to a large extent in healthcare education. Mobile apps can provide extendable learning environments and motivate studen...

    Background: E-learning technology, including mobile applications (apps), is used to a large extent in healthcare education. Mobile apps can provide extendable learning environments and motivate students to adaptive and collaborative learning outside the classroom context. Developers must design practical, effective and easy to use mobile applications. Usability testing is an important part of app development in order to understand if the app meets the needs of the user. 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 healthcare education. Methods: The scoping review is guided by the methodological framework developed by Arksey & O’Malley, and further development by Levac et al. and Kahlil et al. The stages we will follow are: 1) identifying the research question; 2) identifying relevant studies; 3) selecting studies; 4) charting the data, and 5) summarizing and reporting the results. Results: A descriptive summary of included studies will be provided. Tables and graphical illustrations will be used to bring together and present the findings. A thematic analysis of the different usability methods and attributes employed will be presented as a descriptive narrative account of the findings. Conclusions: We expect the overview of usability methods and attributes reported in usability studies of mobile apps for healthcare 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 of the usability research area, including highlighting possible research gaps.

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    Open Peer Review Period: Apr 1, 2020 - May 27, 2020

    Background: People from culturally and linguistically diverse backgrounds (CALD) experience a number of risk factors for mental health problems. However, in comparison to the host population, CALD pop...

    Background: People from culturally and linguistically diverse backgrounds (CALD) experience a number of risk factors for mental health problems. However, in comparison to the host population, CALD populations are less likely to use mental health services. Digital mental health approaches have been shown to be effective in improving wellbeing for the general population; thus, they may provide an effective and culturally appropriate strategy to bridge the treatment gap for CALD populations. Objective: The objective of this scoping review is to provide an overview of the available digital mental health (dMH) resources for CALD populations. Specifically, it aims to answer the following questions: what are the available dMH resources for CALD populations? Are they effective, cost-efficient, feasible, appropriate, and accepted by the population? What are the knowledge gaps in the field? Methods: The methodology will follow the five phases outlined by Arksey and O’Malley (2005) which include: identifying the research question, identifying relevant studies, study selection, charting the data, collating summarizing and reporting the results. Searches were conducted in the following databases: EBSCOhost databases (CINAHL Plus with Full text, MEDLINE with full text, APA PsychArticles, Psychology and Behavioural sciences collection, APA PsychInfo), PubMed, and Scopus. Additionally, OpenGrey, Wonder, Mednar, and Eldis will be searched for grey literature. All primary studies and grey literature in English that include the use of information and communication technology to deliver services targeting mental health issues for CALD populations will be included. Results: Data relating to effectiveness, cost-effectiveness, feasibility, appropriateness, and acceptability will be extracted and included for analysis. The search for the literature started on 20/03/2020. It is anticipated that the data will be collected, analyzed, and for the results to be published in 2020. Conclusions: To date, there are no scoping reviews which have assessed the effectiveness, cost-effectiveness, feasibility, acceptability, and appropriateness of the available digital mental health resources for CALD populations. This review will provide extensive coverage on a promising and innovative intervention for this vulnerable population. It will give insight into the range of approaches, their effectiveness, and progress in their implementation, and provide valuable information for health practitioners, policy makers, and researchers working with CALD populations.

  • Mapping Evidence of Neonatal Resuscitation Training on Practice of Unskilled Birth Attendants in Low- Resource Countries: a scoping review protocol

    Date Submitted: Mar 27, 2020

    Open Peer Review Period: Mar 27, 2020 - May 22, 2020

    Background: Competence in neonatal resuscitation of the newborn is very critical to ensure the safety and health of the newborn infants. Effects of acquisition of neonatal resuscitation skills improve...

    Background: Competence in neonatal resuscitation of the newborn is very critical to ensure the safety and health of the newborn infants. Effects of acquisition of neonatal resuscitation skills improve self-efficacy, thereby reducing neonatal mortality as a result of asphyxia. About one-quarter of all neonatal deaths globally are caused by birth asphyxia. The need for neonatal resuscitation is most imperative in a resource-constrained setting, where access to intrapartum obstetric care is inadequate and poor. Objective: The protocol describes the methodology of a scoping review on evidence of training in neonatal resuscitation and its association with practice in low-resources countries. The aim of the review is to map available evidence of neonatal resuscitation training proficient on unskilled birth attendants practice. Methods: This scoping review protocol uses the framework proposed by Arksey & O’Malley and refined by Levac et al, published by Joanna Briggs Institute while following the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols guidelines. The search strategy was developed with the assistance of the college librarian. Five peer-reviewed data-bases (EBSCOhost (PsychINFO, Wiley online), PubMed, MEDLINE with full-text, Google Scholar (Science Direct), CINAHL Plus with full text EBSCOhost), databases committed to grey literature sources, and reference extraction will be used. Two independent reviewers will screen and extract data. Discrepancies will be resolved by the third reviewer. The extracted data will undergo a descriptive analysis of contextual data and a quantitative analysis using appropriate statistical methods. Results: NULL Conclusions: NULL

  • Active Brains: Protocol for a Feasibility Randomised Control Trial of a Digital Intervention to Reduce Cognitive Decline in Older Adults

    Date Submitted: Mar 27, 2020

    Open Peer Review Period: Mar 27, 2020 - May 22, 2020

    Background: Increasing physical activity, improving diet and doing 'brain training' exercises are associated with reduced cognitive decline in older adults. Here we describe a feasibility trial of the...

    Background: Increasing physical activity, improving diet and doing 'brain training' exercises are associated with reduced cognitive decline in older adults. Here we describe a feasibility trial of the Active Brains intervention, an online digital intervention developed to support older adults to make these three healthy behaviour changes associated with cognitive health. Objective: The Active Brains trial is a randomised feasibility trial that will test how accessible, acceptable and feasible the Active Brains intervention is and the effectiveness of the study procedures that we plan to use in our larger main trial. Methods: We will be trialling the intervention with two populations: 1) older adults with signs of cognitive decline, 2) older adults without any cognitive decline. Trial participants will be randomly allocated to one of three study groups: 1) usual care or 2) the Active Brains intervention, or 3) the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, Quality of Life (using EQ-5D-5L), Instrumental Activities of Daily Living and diagnoses of dementia. Secondary outcomes (including depression, enablement and healthcare costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. Results: Results will be published in peer-reviewed journals, presented at conferences and shared at public engagement events. Conclusions: The findings of this study will help us to identify and make important changes to the website, the support received or the study procedures before we progress to our main randomized phase III trial. Clinical Trial: Trial registration number: ISRCTN 23758980

  • Effectiveness of a Theory-Based, Adaptive E-Learning Program on Acute Care Nurses’ Intentions to Provide Brief Counseling: Multicenter Randomized Controlled Trial Protocol

    Date Submitted: Mar 26, 2020

    Open Peer Review Period: Mar 26, 2020 - May 21, 2020

    Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by acute care nurses is difficult due to contextual and pra...

    Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by acute care nurses is difficult due to contextual and practitioner-level factors impeding nurses’ motivation and intentions to provide brief counseling (e.g., unfavorable attitude toward brief counseling, lack of perceived control linked to barriers). Moreover, most brief counseling training programs lack accessibility and personalization. Theory-based, adaptive e-learning programs could provide accessible and personalized brief counseling training. Objective: This paper presents a study protocol for evaluating the effectiveness of a theory-based, adaptive e-learning program on acute care nurses’ intentions to provide brief counseling for smoking, an unbalanced diet and medication nonadherence. Methods: A two-group, multicenter RCT will be conducted with acute care nurses (N=186). Nurses will be randomized to a theory-based, adaptive e-learning program (E_MOTIVA; experimental group) or knowledge-based, standardized e-learning program (E_MOTIVB; active control group). The E_MOTIVA program was designed to influence the constructs of the Theory of Planned Behavior (e.g., attitude, subjective norm and perceived behavioral control) in relation to brief counseling. The Cognitive Load Index and User Engagement Scale will be used to assess nurses’ cognitive load and engagement related to e-learning. Nurses will complete the Brief Counseling Nursing Practices Questionnaire at baseline and between 41- and 50-day post-randomization. Results: The study is ongoing (ISRCTN32603572). Conclusions: This study will be amongst the first in evaluating a theory-based, adaptive e-learning program in nurses. These programs have the potential to support evidence-based practice through accessible, personalized training in wide-ranging domains in nursing. Clinical Trial: ISRCTN Registry; ISRCTN32603572; https://www.isrctn.com/ISRCTN32603572

  • Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients with Gallbladder Stones and Intermediate Risk for Choledocholithiasis: Study Protocol for a Diagnostic Randomized Trial

    Date Submitted: Mar 22, 2020

    Open Peer Review Period: Mar 22, 2020 - May 17, 2020

    Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancrea...

    Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. Objective: This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. Methods: It is a diagnostic randomized active-controlled single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. Results: The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. Conclusions: This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. Clinical Trial: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

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