JMIR Publications

JMIR Research Protocols

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

Advertisement

Journal Description

 

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

JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)

JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions

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

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

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

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

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

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

 
 

Recent Articles:

  • The Kazakhstan Academy of Preventive Medicine. Source: Image created by the authors; Copyright: The authors; URL: http://www.zdrav.kz/apm/en; License: Creative Commons Attribution (CC-BY).

    Cross-Sectional Study of Chronic Obstructive Pulmonary Disease Prevalence Among Smokers, Ex-Smokers, and Never-Smokers in Almaty, Kazakhstan: Study Protocol

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is significantly underdiagnosed in Kazakhstan, and there is no previously conducted study on COPD prevalence in the country. Objective: The purpose of this study is to assess the prevalence of COPD among individuals aged 40 to 59 years based on results of spirometry before and after bronchodilator, presence of structural changes in the lungs (emphysema, inflammatory changes, and thickening of the walls of the large and small airways) detected by computer tomography, and the symptoms of COPD. The study has 3 study groups: smokers of conventional cigarettes, those who had quit smoking 1 to 5 years ago, and those who haven’t smoked cigarettes. Methods: This is an observational study with a cross-sectional design among individuals aged 40 to 59 years in Almaty, Kazakhstan. The sample of 900 individuals of both sexes contains 500 smokers, 200 ex-smokers, and 200 never-smokers. Study measures include spirometry, chest computed tomography, electrocardiography, physical exams, laboratory testing of serum, anthropometry, and 6-minute walk test. Data are collected by computer-assisted personal interviewing with tablets. The questionnaire was designed to explore possible COPD risk factors including history of smoking, current smoking, level of smoking exposure (in pack-years), passive smoking, occupational and environmental hazards, and covariates: age, gender, ethnicity, education, occupation, and self-reported morbidity. COPD Assessment Test (CAT) is used to collect information about COPD symptoms. Results: We have completed the participant recruitment and study procedures. Currently, we are working on data processing and data analysis. The authors anticipate the preliminary results should be available by September 2017. Study results will be published in peer-reviewed scientific journals. Conclusions: This is the first study in Kazakhstan that assesses prevalence of COPD and its comorbidities in the adult population aged 40 to 59 years. The results of the study will be useful for improving COPD preventive measures, better COPD screening, identification, and registration. Findings of the study will also contribute to global knowledge on the epidemiology of COPD. Trial Registration: ClinicalTrials.gov NCT02926534; https://clinicaltrials.gov/ct2/show/NCT02926534 (Archived by WebCite at http://www.webcitation.org/6rjwGsPOZ)

  • An example of a mobile health app. This one is the AgaMatrix diabetes management app (montage). Source: JMIR Publications/placeit; Copyright: JMIR publications and AgaMatrix Inc.; URL: http://www.researchprotocols.org/2017/7/e133/; License: Creative Commons Attribution (CC-BY).

    Apps for Health-Related Education in Pharmacy Practice: Needs Assessment Survey Among Patients Within a Large Metropolitan Area

    Abstract:

    Background: Patient education resources are crucial to the effectiveness of prescribed pharmacotherapy. However, user interest and patient preference for these materials is lacking. Regardless of the field, nearly every article on designing mHealth apps references the lack of end-user involvement as a key flaw to sustainable design. The traditional paper-based methods of patient education are difficult to tailor to a patient’s specific needs and learning styles, but a customizable app might be beneficial. Objective: Regarding a mobile app for patient education, the objectives of the study were to (1) quantify patient interest, (2) determine desirable features, and (3) determine if a relationship exists between patient variables and interest in an iPad app for patient education. Methods: A paper-based questionnaire was developed and administered to consenting patients receiving care within three sites: two suburban outpatient sites where ambulatory care services are provided and one urban hospital site where ambulatory care transition services are provided. Results: A total of 121 surveys were completed. Most respondents were female (64/120, 53.3%), between 50 and 70 years of age, white/Caucasian (94/120, 78.3%), owned at least one technology device, and knew what an iPad was. Diabetes was the most common disease state (43/120, 35.8%), followed by heart failure (27/120, 22.5%), history of venous thromboembolism (VTE) (21/120, 17.5%), and asthma/chronic obstructive pulmonary disease (17/120, 14.2%). Overall interest in a mobile health app for patient education was 63.7% (72/113). Interest increased to 68.4% (78/114) if a health care provider recommended it. Respondents with one chronic health condition were more likely to be interested in an app compared to those with two or more. Respondents with a history of VTE were mostly likely to be interested in using an app on their own accord, while respondents with diabetes were mostly likely to be interested if their health care provider recommended it. Conclusions: This preliminary needs assessment identified that patients are interested in using mHealth apps for health-related education in pharmacy practice, particularly if their health care provider recommends it.

  • Login page for myDEx. Source: Image created by the authors; Copyright: The authors; URL: http://www.mydexproject.org; License: Creative Commons Attribution (CC-BY).

    Development of a Tailored HIV Prevention Intervention for Single Young Men Who Have Sex With Men Who Meet Partners Online: Protocol for the myDEx Project

    Abstract:

    Background: New cases of human immunodeficiency virus (HIV) among young men who have sex with men (YMSM), aged 18 to 24, underscore the importance of developmentally-informed HIV programs for YMSM. We developed an online intervention focused on risk reduction strategies across different sexual partner types. Intervention activities focus on assisting YMSM reflect on their partner-seeking behaviors, develop sexual decision-making rules to reduce their HIV risks, and consider the adoption of HIV prevention behaviors. Objective: This pilot, randomized controlled trial (RCT) aims to examine the feasibility, acceptability, and preliminary efficacy of a tailored, Web-based HIV prevention intervention for single YMSM. Methods: We designed a prospective RCT of online-recruited cis-gender men (N=180) who reported recent unprotected anal intercourse, self-report as HIV negative or are unaware of their HIV status, and meet sexual partners through online dating apps. Individuals in the control arm receive an attention-control condition that includes HIV/sexually transmitted infection (STI) information currently available on sex education websites. Individuals in the intervention arm receive a 6-session Web-based program tailored on their demographic information, partner-seeking behaviors and relationship desires, and prior sexual attitudes and behaviors. This tailored content will match HIV prevention messages and safer sex skills with YMSM’s outcome expectancies when meeting new partners and thereby help them consider how to integrate safer sex practices into different partner types. Study assessments are taken at baseline, 30-, 60-, and 90-day follow-ups. Intervention acceptability and preliminary efficacy will be explored in sexual risk behaviors and HIV/STI testing. Results: The RCT launched in November 2016 and is ongoing. To date, 180 eligible individuals have been enrolled, consented, and randomized. Of the 120 individuals in the intervention arm, 51.7% (62/120) identify as non-Hispanic white and half of the control arm identifies as non-Hispanic white. There were no differences observed by arm for race and/or ethnicity, age, or sexual orientation. Conclusions: Although there are in-person evidence-based interventions with proven efficacy for YMSM, few HIV/STI prevention interventions delivered online exist. Online interventions may ease access to comprehensive HIV/STI education among YMSM and allow personalized content to be delivered. The online intervention that we developed, myDEx, aims to alleviate the gaps within HIV prevention for YMSM by utilizing tailored, Web-based content with the goal of developing skills for same-sex dating and relationship building, while reducing their risks for HIV/STI. Trial Registration: ClinicalTrials.gov NCT02842060; https://clinicaltrials.gov/ct2/show/NCT02842060 (Archived by WebCite at http://www.webcitation.org/6rcJdxF9v)

  • Screenshot of VA Mobile Health page, US Department of Veterans Affairs website. Source: US Government; Copyright: US Government; URL: https://mobile.va.gov/about; License: Fair use/fair dealings.

    Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study

    Abstract:

    Background: Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. Objective: The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). Methods: We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Results: Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Conclusions: Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. Trial Registration: ClinicalTrials.gov NCT03022669

  • A young man holding an iPad viewing the intervention website (montage). Source: The Authors / Placeit.net; Copyright: Christopher Mejia; URL: http://www.researchprotocols.org/2017/7/e140/; License: Creative Commons Attribution (CC-BY).

    An Intervention Using Gamification to Increase Human Immunodeficiency Virus and Sexually Transmitted Infection Screening Among Young Men Who Have Sex With...

    Abstract:

    Background: In the United States, young men who have sex with men (YMSM) remain disproportionately affected by human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Although routine HIV/STI screening is pivotal to the timely diagnosis of HIV and STIs, initiation of appropriate treatment, and reduced onward disease transmission, repeat screening is underused. Novel interventions that incorporate elements of games, an approach known as gamification, have the potential to increase routinization of HIV/STI screening among YMSM. Objective: The study aims to test the hypothesis that an incentive-based intervention that incorporates elements of gamification can increase routine HIV/STI screening among YMSM in California. Methods: The study consists of a formative research phase to develop the intervention and an implementation phase where the intervention is piloted in a controlled research setting. In the formative research phase, we use an iterative development process to design the intervention, including gathering information about the feasibility, acceptability, and expected effectiveness of potential game elements (eg, points, leaderboards, rewards). These activities include staff interviews, focus group discussions with members of the target population, and team meetings to strategize and develop the intervention. The final intervention is called Stick To It and consists of 3 components: (1) online enrollment, (2) Web-based activities consisting primarily of quizzes and a countdown “timer” to facilitate screening reminders, and (3) in-person activities that occur at 2 sexual health clinics. Participants earn points through the Web-based activities that are then redeemed for chances to win various prizes during clinic visits. The pilot study is a quasi-experimental study with a minimum of 60 intervention group participants recruited at the clinics, at community-based events, and online. We will compare outcomes in the intervention group with a historical control group consisting of individuals meeting the inclusion criteria who attended study clinics in the 12 months prior to intervention implementation. Eligible participants in the pilot study (1) are 18 to 26 years old, (2) were born or identify as male, 3) report male sexual partners, and 4) have a zip code of residence within defined areas in the vicinity of 1 of the 2 implementation sites. The primary outcome is repeat HIV/STI screening within 6 months. Results: This is an ongoing research study with initial results expected in the fourth quarter of 2017. Conclusions: We will develop and pilot test a gamification intervention to encourage YMSM to be regularly screened for HIV/STIs. The results from this research will provide preliminary evidence about the potential effectiveness of using gamification to amplify health-related behavioral change interventions. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. Trial Registration: Clinicaltrials.gov NCT02946164; https://clinicaltrials.gov/ct2/show/NCT02946164 (Archived by WebCite at http://www.webcitation.org/6ri3G4HwD)

  • Source: Flickr; Copyright: Sandy Sarsfield; URL: http://www.flickr.com/photos/46793837@N07/30070457951; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Data Preparation for West Nile Virus Agent-Based Modelling: Protocol for Processing Bird Population Estimates and Incorporating ArcMap in AnyLogic

    Abstract:

    Background: West Nile Virus (WNV) was first isolated in 1937. Since the 1950s, many outbreaks have occurred in various countries. The first appearance of infected birds in Manitoba, Canada was in 2002. Objective: This paper describes the data preparation phase of setting up a geographic information system (GIS) simulation environment for WNV Agent-Based Modelling in Manitoba. Methods: The main technology used in this protocol is based on AnyLogic and ArcGIS software. A diverse variety of topics and techniques regarding the data collection phase are presented, as modelling WNV has many disparate attributes, including landscape and weather impacts on mosquito population dynamics and birds’ roosting locations, population count, and movement patterns. Results: Different maps were combined to create a grid land cover map of Manitoba, Canada in a shapefile format compatible with AnyLogic, in order to modulate mosquito parameters. A significant amount of data regarding 152 bird species, along with their population estimates and locations in Manitoba, were gathered and assembled. Municipality shapefile maps were converted to built-in AnyLogic GIS regions for better compatibility with census data and initial placement of human agents. Accessing shapefiles and their databases in AnyLogic are also discussed. Conclusions: AnyLogic simulation software in combination with Esri ArcGIS provides a powerful toolbox for developers and modellers to simulate almost any GIS-based environment or process. This research should be useful to others working on a variety of mosquito-borne diseases (eg, Zika, dengue, and chikungunya) by demonstrating the importance of data relating to Manitoba and/or introducing procedures to compile such data.

  • PERISCOPE study logo. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/7/e136/; License: Creative Commons Attribution (CC-BY).

    Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale...

    Abstract:

    Background: Patients with gastric cancer and peritoneal carcinomatosis have a very poor prognosis; median survival is 3 to 4 months. Palliative systemic chemotherapy is currently the only treatment available in the Netherlands. Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) has an established role in the treatment of peritoneal carcinomatosis originating from colorectal cancer, appendiceal cancer, and pseudomyxoma peritonei; its role in gastric cancer is uncertain. Currently, there is no consensus on the choice of chemotherapeutic agents used in HIPEC for gastric cancer. Objective: The main objectives of this study are (1) to investigate the safety, tolerability, and feasibility of gastrectomy combined with cytoreductive surgery and HIPEC after systemic chemotherapy, as a primary treatment option for patients with advanced gastric cancer with tumor positive peritoneal cytology and/or limited peritoneal carcinomatosis; and (2) to determine the maximum tolerated dose (MTD) of intraperitoneal docetaxel in combination with a fixed dose of intraperitoneal oxaliplatin. Methods: The PERISCOPE study is a multicenter, open label, phase I-II dose-escalation study. The MTD of docetaxel will be studied using a 3+3 design. Patients with locally advanced (cT3-cT4) gastric adenocarcinoma are eligible for inclusion if the primary gastric tumor is considered resectable, tumor positive peritoneal cytology and/or limited peritoneal carcinomatosis is confirmed by diagnostic laparoscopy/ laparotomy, and prior systemic chemotherapy was without disease progression. At laparotomy, cytoreductive surgery (complete removal of all macroscopically visible tumor deposits) and a total or partial gastrectomy with a D2 lymph node dissection is performed. An open HIPEC technique is used with 460mg/m2 hyperthermic oxaliplatin for 30 minutes (41°C to 42°C) followed by normothermic docetaxel for 90 minutes (37°C) in a dose that will be escalated per 3 patients (0, 50, 75, 100, 125, 150 mg/m2). The primary endpoint is treatment related toxicity. Results: Patient accrual is ongoing and the first results are expected in 2017. Conclusions: The PERISCOPE study will determine the safety, tolerability, and feasibility of gastrectomy combined with cytoreduction and HIPEC using oxaliplatin in combination with docetaxel after systemic chemotherapy as primary treatment option for gastric cancer patients with tumor positive peritoneal cytology and/or limited peritoneal carcinomatosis. This study will provide pharmacokinetic data on the intraperitoneal administration of oxaliplatin and docetaxel, including the MTD of intraperitoneal-administered docetaxel. These data are a prerequisite for the safe conduct of future HIPEC studies in patients with gastric cancer. Trial Registration: Netherlands Trial Registration (NTR): NTR4250; http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=4250 (Archived by WebCite at http://www.webcitation.org/6rWJONgkt)

  • Natural compound inhibitors of the RANKL pathway. Source: Figure 3 from http://www.researchprotocols.org/2017/7/e132; Copyright: the authors; License: Creative Commons Attribution (CC-BY).

    Natural Compounds for the Treatment of Psoriatic Arthritis: A Proposal Based on Multi-Targeted Osteoclastic Regulation and on a Preclinical Study

    Abstract:

    Background: Psoriatic arthritis (PsA) is a chronic inflammatory arthritis affecting approximately 2% to 3% of the population globally, and is characterized by both peripheral articular manifestations and axial skeletal involvement. Conventional therapies for PsA have not been fully satisfactory, though natural products (NPs) have been shown to be highly effective and represent important treatment options for psoriasis. PsA is a multigenic autoimmune disease with both environmental and genetic factors contributing to its pathogenesis. Accordingly, it is likely that the use of natural compounds with a multi-targeted approach will enable us to develop better therapies for PsA and related disorders. Objective: PsA, either on joint damage or on bone erosion, has been shown to respond to anti-psoriatic pharmacotherapy (APP), APP-like NPs, and their natural compounds. This study aims to uncover specific natural compounds for improved PsA remedies. Specifically, by targeting bone erosion caused by increased osteoclastic bone resorption, we aim to predict the key signaling pathways affected by natural compounds. Further, the study will explore their anti-arthritis effects using an in silico, in vitro, and in vivo approach. Following the signaling pathway prediction, a preclinical efficacy study on animal models will be undertaken. Collectively, this work will discover lead compounds with improved therapeutic effects on PsA. Methods: We hypothesize that 9 potential APP-like NPs will have therapeutic effects on arthritis via the modulation of osteoclast bone resorption and signaling pathways. For in silico identification, the Latin name of each NP will be identified using the Encyclopedia of Traditional Chinese Medicine (Encyclopedia of TCM). The biological targets of NPs will be predicted or screened using the Herbal Ingredients' Targets (HIT) database. With the designed search terms, DrugBank will be used to further filter the above biological targets. Protein ANnotation THrough Evolutionary Relationship (PANTHER) will be used to predict the pathways of the natural compound sources. Subsequently, an in vitro sample preparation including extraction, fractionation, isolation, purification, and bioassays with high-speed counter-current chromatography-high-performance liquid chromatography-diode array detection (HSCCC-HPLC-DAD) will be carried out for each identified natural source. In vitro investigations into the effect of NPs on osteoclast signaling pathways will be performed. The experimental methods include cell viability assays, osteoclastogenesis and resorption pit assays, quantitative reverse transcription polymerase chain reaction (RT-PCR), western blot, and luciferase reporter gene assays. Finally, an in vivo preclinical efficacy on a collagen-induced arthritis rat model will be carried out using a treatment group (n=10), a control group (n=10), and a non-arthritis group (n=10). Main outcome measure assessments during intervention include daily macroscopic scores and a digital calipers measurement. Post-treatment tissue measurements will be analyzed by serological testing, radiographic imaging, and histopathological assessment. Results: Studies are currently underway to evaluate the in silico data and the in vitro effects of compounds on osteoclastogenesis and bone resorption. The preclinical study is expected to start a year following completion of the in silico analysis. Conclusions: The in silico rapid approach is proposed as a more general method for adding value to the results of a systematic review of NPs. More importantly, the proposed study builds on a multi-targeted approach for the identification of natural compounds for future drug discovery. This innovative approach is likely to be more precise, efficient, and compatible to identify the novel natural compounds for effective treatment of PsA.

  • Project logo. Source: Image created by the authors; Copyright: The authors; URL: https://www.openrecordings.org; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).

    Sharing Annotated Audio Recordings of Clinic Visits With Patients—Development of the Open Recording Automated Logging System (ORALS): Study Protocol

    Abstract:

    Background: Providing patients with recordings of their clinic visits enhances patient and family engagement, yet few organizations routinely offer recordings. Challenges exist for organizations and patients, including data safety and navigating lengthy recordings. A secure system that allows patients to easily navigate recordings may be a solution. Objective: The aim of this project is to develop and test an interoperable system to facilitate routine recording, the Open Recording Automated Logging System (ORALS), with the aim of increasing patient and family engagement. ORALS will consist of (1) technically proficient software using automated machine learning technology to enable accurate and automatic tagging of in-clinic audio recordings (tagging involves identifying elements of the clinic visit most important to patients [eg, treatment plan] on the recording) and (2) a secure, easy-to-use Web interface enabling the upload and accurate linkage of recordings to patients, which can be accessed at home. Methods: We will use a mixed methods approach to develop and formatively test ORALS in 4 iterative stages: case study of pioneer clinics where recordings are currently offered to patients, ORALS design and user experience testing, ORALS software and user interface development, and rapid cycle testing of ORALS in a primary care clinic, assessing impact on patient and family engagement. Dartmouth’s Informatics Collaboratory for Design, Development and Dissemination team, patients, patient partners, caregivers, and clinicians will assist in developing ORALS. Results: We will implement a publication plan that includes a final project report and articles for peer-reviewed journals. In addition to this work, we will regularly report on our progress using popular relevant Tweet chats and online using our website, www.openrecordings.org. We will disseminate our work at relevant conferences (eg, Academy Health, Health Datapalooza, and the Institute for Healthcare Improvement Quality Forums). Finally, Iora Health, a US-wide network of primary care practices (www.iorahealth.com), has indicated a willingness to implement ORALS on a larger scale upon completion of this development project. Conclusions: Upon the completion of this project we will have developed a novel recording system that will be ready for large-scale testing. Our long-term goal is for ORALS to seamlessly fit into a clinic’s and patient’s daily routine, increasing levels of patient engagement and transparency of care.

  • Source: Pixabay; Copyright: Cyber Rabbit; URL: https://pixabay.com/en/web-macbook-air-apple-graphics-1738168/; License: Public Domain (CC0).

    Effectiveness of Adaptive E-Learning Environments on Knowledge, Competence, and Behavior in Health Professionals and Students: Protocol for a Systematic...

    Abstract:

    Background: Adaptive e-learning environments (AEEs) can provide tailored instruction by adapting content, navigation, presentation, multimedia, and tools to each user’s navigation behavior, individual objectives, knowledge, and preferences. AEEs can have various levels of complexity, ranging from systems using a simple adaptive functionality to systems using artificial intelligence. While AEEs are promising, their effectiveness for the education of health professionals and health professions students remains unclear. Objective: The purpose of this systematic review is to assess the effectiveness of AEEs in improving knowledge, competence, and behavior in health professionals and students. Methods: We will follow the Cochrane Collaboration and the Effective Practice and Organisation of Care (EPOC) Group guidelines on systematic review methodology. A systematic search of the literature will be conducted in 6 bibliographic databases (CINAHL, EMBASE, ERIC, PsycINFO, PubMed, and Web of Science) using the concepts “adaptive e-learning environments,” “health professionals/students,” and “effects on knowledge/skills/behavior.” We will include randomized and nonrandomized controlled trials, in addition to controlled before-after, interrupted time series, and repeated measures studies published between 2005 and 2017. The title and the abstract of each study followed by a full-text assessment of potentially eligible studies will be independently screened by 2 review authors. Using the EPOC extraction form, 1 review author will conduct data extraction and a second author will validate the data extraction. The methodological quality of included studies will be independently assessed by 2 review authors using the EPOC risk of bias criteria. Included studies will be synthesized by a descriptive analysis. Where appropriate, data will be pooled using meta-analysis by applying the RevMan software version 5.1, considering the heterogeneity of studies. Results: The review is in progress. We plan to submit the results in the beginning of 2018. Conclusions: Providing tailored instruction to health professionals and students is a priority in order to optimize learning and clinical outcomes. This systematic review will synthesize the best available evidence regarding the effectiveness of AEEs in improving knowledge, competence, and behavior in health professionals and students. It will provide guidance to policy makers, hospital managers, and researchers in terms of AEE development, implementation, and evaluation in health care. Clinical Trial: PROSPERO International Prospective Register of Systematic Reviews: CRD42017065585; https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017065585 (Archived by WebCite® at http://www.webcitation.org/6rXGdDwf4)

  • Dance promotes the necessary physical benefits in PD as well as stimulate social relations and high self-esteem. Source: Pixabay; Copyright: Franz; URL: https://pixabay.com/pt/hamburgo-tango-argentino-festival-1508776/; License: Public Domain (CC0).

    Brazilian Samba Protocol for Individuals With Parkinson’s Disease: A Clinical Non-Randomized Study

    Abstract:

    Background: In the 10 most populated countries in the world, Parkinson's disease (PD) affects more than 5 million individuals. Despite optimal treatment options already developed for the disease, concomitant involvement of other areas of health care plays an important role in complementing the treatment. From this perspective, dancing can be viewed as a non-drug alternative that can reduce falls by improving some motor skills, such as mobility, balance, gait, and posture, and can also improve the overall quality of life. Brazilian samba promotes improvement in motor and non-motor symptoms in individuals with PD, providing a new treatment option for this population. Objective: The main objective of this quasi-experimental study is to provide a 12-week samba protocol (2x/week) for individuals with PD and to compare its effects with the group without intervention. The hypothesis is that the Brazilian samba protocol will promote improvement in primary (motor) and secondary (non-motor) outcomes in individuals with PD. Methods: The sample will be selected at random from individuals diagnosed with PD in the city of Florianopolis (SC, Brazil). Sample size calculation was performed with the G*Power 3.1.9.2 software, with 0.447 effect size, at 5% significance level, power of 0.9, and test and sample loss of 20%. This yielded 60 individuals divided between the intervention and control groups. The questionnaires will be filled out before and after the dance intervention. The data collection for the control group will be held simultaneously to the intervention group. The classes will last for 1 hour, twice a week in the evening for 12 weeks, and all classes will be divided into warm-up, main part, and relaxation. Two-way analysis of variance with repeated measures and Sidak post-hoc comparison test will be used for a comparative analysis of the final results of the control group with the experimental group and of the within-group changes between pre- and postintervention period. Results: We expect to complete follow-up in September 2017. Conclusions: The major inspiration for this study was to encourage the creation of new rehabilitation programs that do not emphasize doctor involvement. This is a unique protocol for PD and we believe it can be an important tool to alleviate the motor and non-motor symptoms of individuals with PD. Dance is a simple activity depending on little equipment and few financial resources, facilitating its implementation and improving the cost-benefit relationship. In addition, activities that have a cultural aspect for the population in question, and which are pleasant, enable the participants to commit long term. This can enhance patient’s compliance with the therapy, which is often a problem for many rehabilitation programs.

  • Source: Flickr; Copyright: Jos van Zetten; URL: https://www.flickr.com/photos/13088710@N02/3816247410/; License: Creative Commons Attribution (CC-BY).

    The Feasibility and Acceptability of a Web-Based Alcohol Management Intervention in Community Sports Clubs: A Cross-Sectional Study

    Abstract:

    Background: The implementation of comprehensive alcohol management strategies can reduce excessive alcohol use and reduce the risk of alcohol-related harm at sporting venues. Supporting sports venues to implement alcohol management strategies via the Web may represent an effective and efficient means of reducing harm caused by alcohol in this setting. However, the feasibility and acceptability of such an approach is unknown. Objective: This study aimed to identify (1) the current access to and use of the Web and electronic devices by sports clubs; (2) the perceived usefulness, ease of use, and intention to use a Web-based program to support implementation of alcohol management policies in sports clubs; (3) the factors associated with intention to use such a Web-based support program; and (4) the specific features of such a program that sports clubs would find useful. Methods: A cross-sectional survey was conducted with club administrators of community football clubs in the state of New South Wales, Australia. Perceived usefulness, ease of use and intention to use a hypothetical Web-based alcohol management support program was assessed using the validated Technology Acceptance Model (TAM) instrument. Associations between intention to use a Web-based program and club characteristics as well as perceived ease of use and usefulness was tested using Fisher’s exact test and represented using relative risk (RR) for high intention to use the program. Results: Of the 73 football clubs that were approached to participate in the study, 63 consented to participate and 46 were eligible and completed the survey. All participants reported having access to the Web and 98% reported current use of electronic devices (eg, computers, iPads/tablets, smartphones, laptops, televisions, and smartboards). Mean scores (out of a possible 7) for the TAM constructs were high for intention to use (mean 6.25, SD 0.87), perceived ease of use (mean 6.00, SD 0.99), and perceived usefulness (mean 6.17, SD 0.85). Intention to use the Web-based alcohol management program was significantly associated with perceived ease of use (P=.02, RR 1.4, CI 1.0-2.9), perceived usefulness (P=.03, RR 1.5, CI 1.0-6.8) and club size (P=.02, RR 0.8, CI 0.5-0.9). The most useful features of such a program included the perceived ability to complete program requirements within users’ own time, complete program accreditation assessment and monitoring online, develop tailored action plans, and receive email reminders and prompts to complete action. Conclusions: A Web-based alcohol management approach to support sports clubs in the implementation of recommended alcohol management policies appears both feasible and acceptable. Future research should aim to determine if such intended use leads to actual use and club implementation of alcohol management policies.

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Latest Submissions Open for Peer-Review:

View All Open Peer Review Articles
  • Design and rationale of NATURE-AF: the NAtional TUnisian REgistry of Atrial Fibrillation

    Date Submitted: Jul 21, 2017

    Open Peer Review Period: Jul 24, 2017 - Aug 7, 2017

    Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change on the epidemiological pattern of heart disease have been seen in the last three decades, however,...

    Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change on the epidemiological pattern of heart disease have been seen in the last three decades, however, no prospective, multicenter, large trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of atrial fibrillation (AF) patients in Tunisia are limited. Objective: the aim of this study was to analyze, follow and evaluate patients with AF in a large multicenter nation-wide trial. Methods: Methods: One thousand eight hundred consecutive patients with AF in their electrocardiogram, reflecting all the population of all geographical regions of Tunisian will be included in the study, with the objective to describe the epidemiological pattern of AF. Patients will be officially enrolled in the NATURE-AF only if an ECG diagnosis(12-lead ECG, 24 h Holter, or other electrocardiographic documentation)confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrolment. The patients will be followed up for one year. Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular deathwill be recorded as the primary end-point and haemorrhagic accidents, measurement of INR and percent Time In Therapeutic INR Range(TTR) will be recorded as the secondary end-points. Results: Results: Will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse eventswill be determined. NATURE AF will be the first largest registry for North African AF patients. Conclusions: Conclusion: This study would add data and would provide a valuable opportunity for ‘real world’ clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. Clinical Trial: ClinicalTrials.gov Identifier: NCT03085576 (registered on March 2017).

  • Title: The Tapering Practices of Strongman Athletes; A Test-Retest Reliability Study

    Date Submitted: Jul 21, 2017

    Open Peer Review Period: Jul 21, 2017 - Aug 4, 2017

    Background: Currently, little is known about the tapering practices of strongman athletes. We have developed an Internet comprehensive self-report questionnaire examining the training and tapering pra...

    Background: Currently, little is known about the tapering practices of strongman athletes. We have developed an Internet comprehensive self-report questionnaire examining the training and tapering practices of strongman athletes. Objective: The objective of this study was to document the test-retest reliability of questions associated with the Internet comprehensive self-report questionnaire on the tapering practices of strongman athletes. The information will provide insight on the reliability and usefulness of the online questionnaire for use with strongman athletes. Methods: Invitations to complete an Internet questionnaire were sent via ‘Facebook Messenger’ to identified strongman athletes. The survey consisted of four main areas of inquiry including; demographics and background information, training practices, tapering and tapering practices. Of the 454 athletes that completed the survey over the eight-week period, 130 athletes responded on ‘Facebook Messenger’ indicating that they were going to do or had completed the survey. These participants were asked if they could fill the online questionnaire in a second time for a test-retest reliability analysis. Sixty-four athletes (age, 33.3 ±7.7 y; height, 178.2 ±11.0 cm; body mass, 103.7 ±24.8 kg) accepted this invitation and completed the survey for the second time after a minimum 7-day period from the date of their first completion. Agreement between athlete responses was measured using ICC’s and kappa statistics. 95% Confidence intervals were reported for all measures and significance was set at p < 0.05. Results: Test-retest reliability for demographic and training practices items were significant (p < 0.001) and showed excellent (ICC range = .84 to .98) and fair to almost perfect (kappa range = .37 to .85) agreement. Moderate to excellent agreement (ICC range = .56 to .84; p < 0.01) were observed for all tapering practices measures except for the number of days’ athletes started their usual taper before a strongman competition (ICC = .30). When the number of days were categorized with additional analysis, moderate reliability was observed (kappa=.43; p <0.001). Fair to substantial agreement was observed for the majority of tapering practices measures (kappa range = .38 to .73; p <0.001) except for how training frequency (kappa=.26) and the percentage and type of resistance training performed changed in the taper (kappa=.20). Good to excellent agreement (ICC = .62 to .93; p < 0.05) was observed for items relating to strongman events and traditional exercises performed during the taper. Only the time at which the Farmers walk was last performed before competition showed poor reliability (ICC = .27). Conclusions: We have developed a low cost, self-reported, online retrospective questionnaire, which provided stable and reliable answers for most of the demographic, training and tapering practice questions. The results of this study support the inferences drawn from the tapering practices of strongman athletes study.

  • Uterine artery embolization versus hysterectomy in the treatment of symptomatic adenomyosis: design of the randomized QUESTA trial.

    Date Submitted: Jul 19, 2017

    Open Peer Review Period: Jul 21, 2017 - Aug 4, 2017

    Background: Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is establi...

    Background: Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is established as the final treatment option when conservative treatment fails. Uterine artery embolization (UAE) in patients with symptomatic adenomyosis has demonstrated to reduce symptoms and improve quality of life, however randomized controlled trials are lacking. Objective: With this study we aim to evaluate the impact of UAE on Health Related Quality of life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. Methods: This is a multicenter non-blinded randomized controlled trial comparing UAE and hysterectomy. Eligible patients are symptomatic premenopausal women without the desire to conceive and who have symptomatic MRI confirmed pure adenomyosis or dominant adenomyosis accompanied by fibroids. After obtaining informed consent, patients will be randomly allocated to treatment in a 2:1 UAE versus hysterectomy ratio. The primary objective is HRQOL at 6 months following the assigned intervention. Secondary outcomes are technical results, pain management, clinical outcomes, HRQOL, and cost effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE. Results: Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At time of submission of this article data cleaning and analyses have not yet started. Conclusions: This trial will provide insight for care takers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients’ wellbeing and quality of life. Clinical Trial: NetherlandsTrial Register NTR5615. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615

  • Design and methods of Get Social: A non-inferiority trial comparing clinic- versus online social network-delivered lifestyle interventions

    Date Submitted: Jul 20, 2017

    Open Peer Review Period: Jul 21, 2017 - Aug 4, 2017

    Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Though online social networks have been integrated as one component of multi-modality...

    Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Though online social networks have been integrated as one component of multi-modality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network to a traditional clinic-delivered intervention. This paper describes the design and methods of a non-inferiority randomized controlled trial testing whether a lifestyle intervention delivered entirely through an online social network will produce weight loss that is not appreciably worse than a traditional clinic-based lifestyle intervention among overweight and obese adults, but at lower cost. Adults with BMI between 27-45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. Measures will be obtained at baseline, 6-, and 12-months after randomization. The primary non-inferiority outcome is percent weight loss at 12 months. Secondary non-inferiority outcomes include dietary intake, and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an efficacious alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models.

  • MyVoice National Text Message Survey of Youth 14-24yo: Study Protocol

    Date Submitted: Jul 18, 2017

    Open Peer Review Period: Jul 19, 2017 - Aug 2, 2017

    Background: Adolescent health in the US has not improved in decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health...

    Background: Adolescent health in the US has not improved in decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Objective: Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real-time to leverage youth perspectives to impact policy. Methods: Youth age 14-24 are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers and policy makers to inform salient policies. A youth centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required as the survey is of minimal risk to participants. Recruitment occurs online (e.g., Facebook, Instagram, UMHealthResearch.org), in person at community events, and through snowball sampling. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. Results: We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. Conclusions: MyVoice quickly ascertains the thoughts and opinions of youth in real-time using a widespread, readily available technology– text messaging. Results are disseminated to policy makers and youth-serving organizations through a variety of methods. Policy makers and organizations then share their priority areas with the research team to develop additional question sets to inform important policy decisions. Youth-serving organizations can use results to make decisions to promote youth well being.

  • Psychosocial distress of patients with psoriasis: Assessment of care needs and development of a supportive intervention: a study protocol

    Date Submitted: Jul 17, 2017

    Open Peer Review Period: Jul 18, 2017 - Aug 1, 2017

    Background: Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (soci...

    Background: Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. Objective: The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; 2) to develop a supportive intervention based on the prior results. Methods: A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. Conclusions: The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed.

Advertisement