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JMIR Research Protocols

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

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Journal Description

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 
 

Recent Articles:

  • Source: Freepik; Copyright: bearfotos; URL: https://www.freepik.com/free-photo/serious-mature-woman-with-pills-and-glass-of-water_1474426.htm; License: Licensed by JMIR.

    Safer Prescribing and Care for the Elderly (SPACE): Protocol of a Cluster Randomized Controlled Trial in Primary Care

    Abstract:

    Background: High-risk prescribing, adverse drug events, and avoidable adverse drug event hospitalizations are common. The single greatest risk factor for high-risk prescribing and adverse drug events is the number of medications a person is taking. More people are living longer and taking more medications for multiple long-term conditions. Most on-going prescribing occurs in primary care. The most effective, cost-effective, and practical approach to safer prescribing in primary care is not yet known. Objective: To test the effect of the Safer Prescribing And Care for the Elderly (SPACE) intervention on high-risk prescribing of nonsteroidal anti-inflammatory and antiplatelet medicines, and related adverse drug event hospitalizations. Methods: This is a protocol of a cluster randomized controlled trial. The clusters will be primary care practices. Data collection and analysis will be at the level of patient. Results: Recruitment started in 2018. Six-month data collection will be in 2018. Conclusions: This study addresses an important translational gap, testing an intervention designed to prompt medicines review and support safer prescribing in routine primary care practice. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12618000034235 http://www.ANZCTR.org.au/ACTRN12618000034235.aspx (Archived with Webcite at http://www.webcitation.org/6yj9RImDf)

  • Researcher using Google Scholar to identify randomized controlled trials/nonrandomized studies on combined oral contraceptives (montage). Source: Google Scholar / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/4/e113/; License: Creative Commons Attribution (CC-BY).

    Comparing the Effects of Combined Oral Contraceptives Containing Progestins With Low Androgenic and Antiandrogenic Activities on the...

    Abstract:

    Background: Different products of combined oral contraceptives (COCs) can improve clinical and biochemical findings in patients with polycystic ovary syndrome (PCOS) through suppression of the hypothalamic-pituitary-gonadal (HPG) axis. Objective: This systematic review and meta-analysis aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the HPG axis in patients with PCOS. Methods: We searched PubMed, Scopus, Google Scholar, ScienceDirect, and Web of Science databases (1980-2017) to identify randomized controlled trials or nonrandomized studies investigating the effect of COCs containing progestins with low androgenic and antiandrogenic activities, including the products containing desogestrel, cyproterone acetate, and drospirenone, on the HPG axis in patients with PCOS. In this meta-analysis, fixed and random effect models were used. Outcomes of interest were weighted mean differences (WMD) of hormonal parameters, including the follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH-to-FSH ratio, estradiol, total testosterone, and sex hormone–binding globulin. Potential sources of heterogeneity were investigated using meta-regression and subgroup analyses. Subgroup analyses were performed based on the used progestin compound and treatment duration. We assessed quality of included studies and their risk of bias using Cochrane guidelines. Publication bias was assessed using Egger test and funnel plot. Results: COC use was significantly associated with a decrease in gonadotropin levels, including FSH and LH. Use of products containing cyproterone acetate was associated with a decrease in FSH levels after 3 months (WMD=−0.48; 95% CI −0.81 to −0.15), 6 months (WMD=−2.33; 95% CI −3.48 to −1.18), and 12 months (WMD=−4.70; 95% CI −4.98 to −4.42) and a decrease in LH levels after 3 months (WMD=−3.57; 95% CI −5.14 to −1.99), 6 months (WMD=−5.68; 95% CI −9.57 to −1.80), and 12 months (WMD=−11.60; 95% CI −17.60 to −5.60). Use of COCs containing drospirenone for 6 months decreased FSH (WMD=−0.93; 95% CI −1.79 to −0.08) and LH (WMD=−4.59; 95% CI −7.53 to −1.66) levels. Data for products containing desogestrel were few, but this compound generally had no statistically significant influence on gonadotropin levels similar to that observed with COCs containing cyproterone acetate and drospirenone. Use of COCs was not associated with any significant change in LH-to-FSH ratio. COCs containing cyproterone acetate showed maximum effect on gonadotropin suppression. COCs containing cyproterone acetate significantly decreased estradiol concentrations, whereas those containing drospirenone exhibited no such effect. All COCs demonstrated improvement in androgenic profile and had the same effects on total testosterone and sex hormone–binding globulin concentrations. Progestin compound and treatment duration had no statistically significant effects on changing total testosterone and sex hormone–binding globulin levels. Conclusions: COCs containing cyproterone acetate can effectively suppress gonadotropins, leading to a decrease in androgenic parameters. Although different products of COCs could significantly suppress the androgenic profile, it seems that products containing cyproterone acetate are more effective in suppressing gonadotropin and estradiol levels in patients with PCOS.

  • Man doing Web-based survey on prostrate cancer. Source: Pexels; Copyright: Bruce Mars; URL: https://www.pexels.com/photo/man-wearing-gray-blazer-838413/; License: Public Domain (CC0).

    Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation

    Abstract:

    Background: While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective: This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods: The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results: Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions: Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed.

  • Doctor holding gauze to treat a wound. Source: Pixnio; Copyright: Kelly Thomas, USCDCP; URL: https://pixnio.com/science/medical-science/gauze-and-medical-tape-can-be-used-when-fashioning-such-a-bandage; License: Public Domain (CC0).

    An mHealth App for Decision-Making Support in Wound Dressing Selection (WounDS): Protocol for a User-Centered Feasibility Study

    Abstract:

    Background: Primary care health professionals, especially family physicians, see a variety of wounds, and yet—despite the frequency of providing wound care—many family physicians do not feel confident in wound care management. This is partly due to a lack of formal wound education in Family Medicine programs. While there are numerous electronic wound care resources available in the UK and North America, none were identified that address the specific need in supporting clinical decision-making in wound dressing selection. At the same time, healthcare providers are increasingly using technology in personal and professional contexts, and a logical extension is to use technology for knowledge translation strategies. Objective: This work developed a prototype mobile health software application named WounDS, designed to support clinical decision-making in selecting wound dressings. This article presents the development and evaluation plan for the WounDS app. Methods: WounDS has been developed on the iOS platform. The primary specification included ease of use, in that one of the primary influences in user adoption would be the ability to receive a wound dressing recommendation in under 30 seconds and under 5 taps on the screen. The WounDS app guides users through a series of binary decisions for assessing the wound and provides a wound dressing recommendation. The selection algorithm is based in best practices using the Wound Bed Preparation Paradigm. Results: Current work is underway to examine the implementation needs for WounDS to be most effectively utilized and to pilot test its feasibility and use in clinical care. Data will be collected through user trials, focus groups, and user metadata will be collected within the app. Optimizing these preconditions will enable a subsequent phase of study to determine effects on clinical decision-making and clinical outcomes. Conclusions: WounDS is designed for knowledge translation, use of technology in clinical decision-making, and continuity of care. The benefits of WounDS include the potential to improve healthcare providers’ competency in wound management and to improve wound healing through better alignment with evidence-based best practices in wound dressing selection, consistency in care from primary to community care, and subsequent downstream impacts in quality of life for patients.

  • Source: Freepik; Copyright: phduet; URL: https://www.freepik.com/free-photo/woman-with-a-baby-looking-at-his-laptop_966465.htm#term=mom%20laptop&page=1&position=3; License: Licensed by JMIR.

    Perceptions About Disseminating Health Information Among Mommy Bloggers: Quantitative Study

    Abstract:

    Background: Social media are potentially powerful channels for communicating relevant health information in culturally sensitive and influential ways to key audiences. Moreover, these channels hold promise for promoting awareness and knowledge of health risks, prevention, and treatment by utilizing opinion leaders for message dissemination. Despite limited empirical evidence to-date, early promising results suggest that blogs are a form of social media that should be examined as worthy channels for health communication. Objectives: This formative study explored mommy bloggers’ perceptions about sharing health-related information on their blogs with their readers. It also sought to analyze which topics would be of most interest to mommy bloggers, what motivates them to write about health issues, and how they perceive interest in these topics among their readers. Methods: This study employed survey methodology, including the use of open-ended questions, the responses to which were coded for analysis. Specifically, a 14-item survey was fielded with mommy bloggers between October 1 and October 28, 2016. Bloggers were recruited through The Motherhood network. A total of 461 mommy bloggers responded to the survey; 163 were removed for low quality responses and incomplete data. As a result, 298 eligible participants completed the survey. For open-ended questions in the survey, a sample of responses were coded and analyzed. Results: The majority of the respondents (87.2%, 260/298) reported that they have written about health issues in the past; 97.3% (290/298) of the respondents reported that they would consider writing about health issues sometime in the future, and 96.3% (287/298) of the respondents reported that their readers like to read about health issues on their blogs. In terms of content priorities for this sample of bloggers, Nutrition and Physical Activity dominate the current conversation and similarly, Physical Activity and Nutrition remain top content priorities for these bloggers for the future. Moreover, 21.3% of the respondents reported that their readers would be interested in these topics. Finally, having a personal connection with a health issue was found to be positively associated with likeliness to write about health issues on their blog (P<.001). Conclusions: This study illustrates that there are potentially rich opportunities for working with mommy bloggers to communicate with key health decision makers (moms) on important health issues. There is a great support among mommy bloggers for health information dissemination as well as interest for accessing relevant health information from their readers. This presents an opportunity for public health research and communication campaigns to more broadly promote their messages, thereby contributing to their behavior change objectives. Limitations included overrepresentation of white, higher-educated, and younger women. It suggests a need for more targeted engagement of a diverse sample for future work.

  • Data acquisitions during gait. Source: Image created by the Authors; Copyright: The authors; URL: http://www.researchprotocols.org/2018/4/e104/; License: Creative Commons Attribution (CC-BY).

    Identifying Subgroups of Patients With Chronic Nonspecific Low Back Pain Based on a Multifactorial Approach: Protocol For a Prospective Study

    Abstract:

    Background: Low back pain, especially nonspecific chronic low back pain (LBP), the leading cause of disability worldwide, represents both social and economic problems. Different therapeutic management techniques can be used, but their effects vary. Clinicians and researchers attribute the variation in the efficacy of therapeutic and management techniques to the heterogeneity of the nonspecific chronic low back pain population, and they agree that nonspecific chronic LBP must be subgrouped. Objective: This study aims to identify nonspecific chronic LBP subgroups based on a multifactorial approach, including biomechanical, physical, and psychosocial data. Methods: A total of 100 nonspecific chronic LBP patients and 30 healthy participants aged between 18 and 60 years will be recruited for this prospective study. A psychosocial profile will be established using questionnaires on anxiety, depression, functional disability, pain, fear of pain, avoidance belief, and physical activity. A physical capacity evaluation will be conducted. It will evaluate flexibility of the hips, lumbar spine, and lateral thoracolumbar segment, as well as trunk (extensor and flexor) muscle endurance. The subjects will perform functional daily life activities, such as walking, object lifting, forward bending, sit-to-stand, stand-to-sit, balance, and usual postures. Full body kinematics, kinetics, and surface electromyography of the trunk and hip muscles will be assessed during these tasks. The clustering classification methods for the statistical analysis will be determined according to the data and will be used to identify the subgroups of nonspecific chronic LBP patients. Results: Data collection started in September 2017 and will be completed with the inclusion of all the participants (100 nonspecific chronic LBP and 30 control). The study results will be published in peer-reviewed journals and presented at relevant international conferences. Conclusions: Numerous studies have showed that the therapeutic management of nonspecific chronic LBP is difficult and has inconstant effects caused by the complexity and heterogeneity of nonspecific chronic LBP. Identifying subgroups with a multifactorial approach is more comprehensive and closer to the pathophysiology of nonspecific chronic LBP. It also represents benefit interests and a challenge both clinically and socially. The perspective of this study is expected to support clinicians for a more adapted therapeutic management for each subgroup.

  • Source: Horyzons / Orygen, The National Centre of Excellence in Youth Mental Health / The University of Melbourne / Australian Catholic University / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/4/e100/; License: Creative Commons Attribution (CC-BY).

    Cultural and Contextual Adaptation of an eHealth Intervention for Youth Receiving Services for First-Episode Psychosis: Adaptation Framework and Protocol for...

    Abstract:

    Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to pay greater attention to policy, services, and research with respect to eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The Web-based platform, called Horyzons, was initially developed and tested in Australia and is now being prepared for evaluation in Canada. Methods: Service users and service providers from 2 specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection was completed in August 2017, and analysis and adaptation are in process. The first results of the study will be submitted for publication in 2018 and will provide preliminary insights into the acceptability of the Web-based platform (eg, perceived use and perceived usefulness) from service provider and service user perspectives. The project will also provide knowledge about the adaptations and process needed to prepare the platform for evaluation in Canada. Conclusions: This study contributes to an important gap in the literature pertaining to the specific principles, methods, and steps involved in adapting eHealth interventions for implementation and evaluation across a diverse range of cultural, geographical, and health care settings.

  • Oral lesions in patient with mucositis. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e103/; License: Creative Commons Attribution (CC-BY).

    Impact of Oral Side Effects from Conditioning Therapy Before Hematopoietic Stem Cell Transplantation: Protocol for a Multicenter Study

    Abstract:

    Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. Objective: The objectives of this prospective international observational multicenter study in hematopoietic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal relationship of oral complications related to conditioning regimens (chemotherapy with or without total body irradiation), stem cell transplantation and the immunologic reactions (mainly graft-vs-host-disease) that may follow, and to determine what subjective and objective oral complications related to treatment can predict negative clinical and economic outcomes and reduced quality of life. Methods: Adult patients at six study sites receiving full intensity conditioning, reduced intensity conditioning or nonmyeloablative conditioning, followed by autologous or allogeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, social history, patient report of oral problems, dental history, subjective oral complaints, objective measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days per week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mucositis or other oral problems are followed 1 day per week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days (SD 30 days) and at 1 year (SD 30 days) post-transplantation to identify any long-term side effects. Patients treated with allogeneic transplantation are being followed at 100 days (SD 30 days), 6 months (SD 30 days), and 12 months (SD 30 days). The follow-up assessments include cancer response to therapy, current medical conditions, medications, subjective and objective oral findings, quality of life measures and laboratory values. The targeted enrollment is 254 patients who have received HSCT. Results: A total of 260 participants have been enrolled, with 233 (91%) who have received HSCT. We anticipate enrollment of 20-30 additional participants to obtain the sample size of 254 enrolled participants who have received HSCT. Conclusions: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed evidence for guidelines regarding the management of this patient cohort.

  • The DIABEO app (montage). Source: Sanofi / Smartmockups.com; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/4/e66/; License: Creative Commons Attribution (CC-BY).

    DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

    Abstract:

    Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective: Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods: TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results: The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions: The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration: ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd)

  • Woman receiving contraceptive counseling. Source: Shutterstock; Copyright: Rocketclips, Inc; URL: https://www.shutterstock.com/image-photo/asian-physician-explaining-new-prescription-black-221885875?src=VR8kpRdOh-evz_ZLQiZpYg-1-7; License: Licensed by the authors.

    A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study

    Abstract:

    Background: Women with chronic medical conditions, such as diabetes and hypertension, have a higher risk of pregnancy-related complications compared with women without medical conditions and should be offered contraception if desired. Although evidence based guidelines for contraceptive selection in the presence of medical conditions are available via the United States Medical Eligibility Criteria (US MEC), these guidelines are underutilized. Research also supports the use of decision tools to promote shared decision making between patients and providers during contraceptive counseling. Objective: The overall goal of the MiHealth, MiChoice project is to design and implement a theory-driven, Web-based tool that incorporates the US MEC (provider-level intervention) within the vehicle of a contraceptive decision tool for women with chronic medical conditions (patient-level intervention) in community-based primary care settings (practice-level intervention). This will be a 3-phase study that includes a predesign phase, a design phase, and a testing phase in a randomized controlled trial. This study protocol describes phase 1 and aim 1, which is to determine patient-, provider-, and practice-level factors that are relevant to the design and implementation of the contraceptive decision tool. Methods: This is a mixed methods implementation study. To customize the delivery of the US MEC in the decision tool, we selected high-priority constructs from the Consolidated Framework for Implementation Research and the Theoretical Domains Framework to drive data collection and analysis at the practice and provider level, respectively. A conceptual model that incorporates constructs from the transtheoretical model and the health beliefs model undergirds patient-level data collection and analysis and will inform customization of the decision tool for this population. We will recruit 6 community-based primary care practices and conduct quantitative surveys and semistructured qualitative interviews with women who have chronic medical conditions, their primary care providers (PCPs), and clinic staff, as well as field observations of practice activities. Quantitative survey data will be summarized with simple descriptive statistics and relationships between participant characteristics and contraceptive recommendations (for PCPs), and current contraceptive use (for patients) will be examined using Fisher exact test. We will conduct thematic analysis of qualitative data from interviews and field observations. The integration of data will occur by comparing, contrasting, and synthesizing qualitative and quantitative findings to inform the future development and implementation of the intervention. Results: We are currently enrolling practices and anticipate study completion in 15 months. Conclusions: This protocol describes the first phase of a multiphase mixed methods study to develop and implement a Web-based decision tool that is customized to meet the needs of women with chronic medical conditions in primary care settings. Study findings will promote contraceptive counseling via shared decision making and reflect evidence-based guidelines for contraceptive selection. Trial Registration: ClinicalTrials.gov NCT03153644; https://clinicaltrials.gov/ct2/show/NCT03153644 (Archived by WebCite at http://www.webcitation.org/6yUkA5lK8)

  • Source: CDC Public Health Image Library; Copyright: Amanda Mills; URL: https://phil.cdc.gov/Details.aspx?pid=13979; License: Public Domain (CC0).

    An Exercise Intervention to Unravel the Mechanisms Underlying Insulin Resistance in a Cohort of Black South African Women: Protocol for a Randomized...

    Abstract:

    Background: The pathogenesis of type 2 diabetes (T2D) in black African women is complex and differs from that in their white counterparts. However, earlier studies have been cross-sectional and provide little insight into the causal pathways. Exercise training is consistently used as a model to examine the mechanisms underlying insulin resistance and risk for T2D. Objective: The objective of the study was to examine the mechanisms underlying the changes in insulin sensitivity and secretion in response to a 12-week exercise intervention in obese black South African (SA) women. Methods: A total of 45 obese (body mass index, BMI: 30-40 kg/m2) black SA women were randomized into a control (n=22) or experimental (exercise; n=23) group. The exercise group completed 12 weeks of supervised combined aerobic and resistance training (40-60 min, 4 days/week), while the control group maintained their typical physical activity patterns, and both groups were requested not to change their dietary patterns. Before and following the 12-week intervention period, insulin sensitivity and secretion (frequently sampled intravenous glucose tolerance test) and its primary and secondary determinants were measured. Dietary intake, sleep quality and quantity, physical activity, and sedentary behaviors were measured every 4 weeks. Results: The final sample included 20 exercise and 15 control participants. Baseline sociodemographics, cardiorespiratory fitness, anthropometry, cardiometabolic risk factors, physical activity, and diet did not differ between the groups (P>.05). Conclusions: The study describes a research protocol for an exercise intervention to understand the mechanisms underlying insulin sensitivity and secretion in obese black SA women and aims to identify causal pathways underlying the high prevalence of insulin resistance and risk for T2D in black SA women, targeting specific areas for therapeutic intervention. Trial Registration: Pan African Clinical Trial Registry PACTR201711002789113; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?_nfpb=true&_pageLabel=portals_app_atmregistry_portal_page_13 (Archived by WebCite at http://www.webcitation.org/6xLEFqKr0)

  • Using a mobile phone to collect patient data. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e102/; License: Creative Commons Attribution (CC-BY).

    Capturing Ultraviolet Radiation Exposure and Physical Activity: Feasibility Study and Comparison Between Self-Reports, Mobile Apps, Dosimeters, and...

    Abstract:

    Background: Skin cancer is the most prevalent cancer in Australia. Skin cancer prevention programs aim to reduce sun exposure and increase sun protection behaviors. Effectiveness is usually assessed through self-report. Objective: It was the aim of this study to test the acceptance and validity of a newly developed ultraviolet radiation (UVR) exposure app, designed to reduce the data collection burden to research participants. Physical activity data was collected because a strong focus on sun avoidance may result in unhealthy reductions in physical activity. This paper provides lessons learned from collecting data from participants using paper diaries, a mobile app, dosimeters, and accelerometers for measuring end-points of UVR exposure and physical activity. Methods: Two participant groups were recruited through social and traditional media campaigns 1) Group A—UVR Diaries and 2) Group B—Physical Activity. In Group A, nineteen participants wore an UVR dosimeter wristwatch (University of Canterbury, New Zealand) when outside for 7 days. They also recorded their sun exposure and physical activity levels using both 1) the UVR diary app and 2) a paper UVR diary. In Group B, 55 participants wore an accelerometer (Actigraph, Pensacola, FL, USA) for 14 days and completed the UVR diary app. Data from the UVR diary app were compared with UVR dosimeter wristwatch, accelerometer, and paper UVR diary data. Cohen kappa coefficient score was used to determine if there was agreement between categorical variables for different UVR data collection methods and Spearman rank correlation coefficient was used to determine agreement between continuous accelerometer data and app-collected self-report physical activity. Results: The mean age of participants in Groups A (n=19) and B (n=55) was 29.3 and 25.4 years, and 63% (12/19) and 75% (41/55) were females, respectively. Self-reported sun exposure data in the UVR app correlated highly with UVR dosimetry (κ=0.83, 95% CI 0.64-1.00, P<.001). Correlation between self-reported UVR app and accelerometer-collected moderate to vigorous physical activity data was low (ρ=0.23, P=.10), while agreement for low-intensity physical activity was significantly different (ρ=-0.49, P<.001). Seventy-nine percent of participants preferred the app over the paper diary for daily self-report of UVR exposure and physical activity. Conclusions: This feasibility study highlights self-report using an UVR app can reliably collect personal UVR exposure, but further improvements are required before the app can also be used to collect physical activity data.

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    Open Peer Review Period: Apr 25, 2018 - May 9, 2018

    Introduction: Pressure ulcers and deep tissue injuries, collectively known as pressure injures (PrI) are serious complications causing staggering costs and human suffering with over 200 reported risk...

    Introduction: Pressure ulcers and deep tissue injuries, collectively known as pressure injures (PrI) are serious complications causing staggering costs and human suffering with over 200 reported risk factors from many domains. Primary PrI prevention seeks to prevent initial incidence, while secondary PU/DTI prevention seeks to decrease chronic recurrence. Clinical practice guidelines (CPG) combine evidence based practice and expert opinion to aid clinicians in the goal of achieving best practices for primary and secondary prevention. The correction of all risk factors can be both overwhelming and impractical to implement in clinical practice. There is a need to develop effective clinical tools to prioritize the multiple recommendations of CPG but there is limited guidance on how to prioritize based on individual cases. Bioinformatics platforms enable data management to support clinical decision support and user-interface development for complex clinical challenges such as PrI prevention care planning. Objective/Hypothesis: The central hypothesis of the study is that the individual’s risk factor profile can provide the basis for adaptive personalized care planning for PU prevention based on CPG prioritization. The study objective is to develop the Spinal Cord Injury Pressure Ulcer and Deep tissue injury (SCIPUD+) Resource to support personalized care planning for primary and secondary PU/DTI prevention. Methods: The study is employing a retrospective electronic health record (EHR) chart review of over 75 factors known to be relevant for PrI risk in individuals with SCI and routinely recorded in the EHR. We also perform tissue health assessments of a selected sub-group. A systems approach is being used to develop and validate the SCIPUD+ Resource incorporating the many risk factor domains associated with PU/DTI primary and secondary prevention, ranging from the individual’s environment to local tissue health. Our multi-scale approach will leverage the strength of bioinformatics applied to an established national EHR system. A comprehensive model is being used to relate the primary outcome of interest (PU/DTI development) with over 75 PU/DTI risk factors using a retrospective chart review of 5000 individuals selected from the study cohort of over 36,000 individuals with SCI. A SCI PU/DTI specific ontology, SCIPUDO, is being developed to enable robust text-mining for data extraction from free form notes. Discussion: PU/DTI remains a highly significant source of morbidity for individuals with SCI. Personalized interactive care plans may decrease both initial PU formation and readmission rates for high-risk individuals. The project is using established EHR data to build a comprehensive structured model of environmental, social and clinical PrI risk factors. The comprehensive SCIPUD+ healthcare tool will be used to relate the primary outcome of interest (PrI development) with covariates including environmental, social, clinical, personal and tissue health profiles as well as possible interactions among some of these covariates. The study will result in a validated tool for personalized implementation of CPG recommendations and has great potential to change the standard of care for PrI clinical practice by enabling clinicians to provide personalized application of CPG priorities tailored to the needs of each at-risk individual with SCI.

  • Does connectivity of the stimulated motor network predict response to anodal transcranial direct current stimulation in people with stroke? A protocol for a double-blind randomised controlled trial

    Date Submitted: Apr 23, 2018

    Open Peer Review Period: Apr 24, 2018 - May 8, 2018

    Background: Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological...

    Background: Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological rehabilitation. One approach is to use non-invasive brain stimulation techniques, such as transcranial direct current stimulation, to induce a neuroplastic response. When delivered in combination with rehabilitation exercises, there is some evidence that transcranial direct current stimulation is beneficial. However, responses to stimulation are highly variable. Therefore biomarkers predictive of response to stimulation would be valuable to help select appropriate people for this potentially beneficial treatment. Objective: The objective of this study is to investigate connectivity of the stimulation target, the ipsilesional motor cortex, as a biomarker predictive of response to anodal transcranial direct current stimulation in people with stroke. Methods: This study is a double blind, randomised controlled trial (RCT), with two parallel groups. A total of 60 participants with first ever ischemic stroke with motor impairment will undertake a two week (14 session) treatment for upper limb function (Graded Repetitive Arm Supplementary Program; GRASP). Participants will be randomised 2:1 to active:sham treatment groups. Those in the active treatment group will receive anodal transcranial direct current stimulation to the ipsilesional motor cortex at the start of each GRASP session. Those allocated to the sham treatment group will receive sham transcranial direct current stimulation. Behavioural assessments of upper limb function will be performed at baseline, post treatment, 1 month follow-up and 3 months follow-up. Neurophysiological assessments will include magnetic resonance imaging (MRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) and will be performed at baseline, post treatment, 1 month follow-up (EEG and TMS only) and 3 months follow-up (EEG and TMS only). Results: Participants will be recruited between March 2018 and December 2018, with experimental testing concluding in March 2019. Conclusions: Identifying a biomarker predictive of response to transcranial direct current stimulation would greatly assist clinical utility of this novel treatment approach. Clinical Trial: Australia New Zealand Clinical Trials Registry; ACTRN12618000443291. Website http://www.ANZCTR.org.au/ACTRN12618000443291.aspx

  • Pediatric Respiratory Etiology Surveillance Study (PRESS): Methodology for Determination of Cause of Death among Children Hospitalized with Respiratory Illness in Kenya.

    Date Submitted: Apr 23, 2018

    Open Peer Review Period: Apr 23, 2018 - May 7, 2018

    Background: In the past decade, the introduction and expansion of vaccination against major causes of childhood respiratory diseases and public health interventions to reduce the burden of HIV/AIDS an...

    Background: In the past decade, the introduction and expansion of vaccination against major causes of childhood respiratory diseases and public health interventions to reduce the burden of HIV/AIDS and malaria, may have changed the contribution of different pathogens to respiratory deaths worldwide. In sub-Saharan Africa, where burden of respiratory disease deaths is highest, information on cause of death remains inadequate due to poor access to healthcare and limited availability of diagnostic tools. Postmortem examination can aid in ascertainment of causes of death. Objective: This report describes the Pediatric Respiratory Etiology Surveillance Study (PRESS) which seeks to identify causes and etiologies associated with respiratory disease deaths among children 1-59 months old hospitalized with respiratory illness admitted to the Kenyatta National Hospital, the largest public hospital in Kenya, through postmortem examination coupled with innovative approaches to laboratory investigation. Methods: Using an existing hospital-based respiratory disease surveillance system, we prospectively followed enrolled children until end of clinical care or death. In case of death, parents/guardians were offered grief counseling and consent was sought for postmortem examination of their child. Study pathologists systematically collected lung tissue specimens using minimally invasive tissue sampling techniques followed by collection of lung and other tissue specimens during conventional autopsy. These tissues were tested using histopathology, immunohistochemistry and multiple-pathogen molecular-based assays to identify pathogens. For each case, clinical and laboratory data were reviewed by a team of pathologists, clinicians, laboratorians and epidemiologists to systematically assign a cause of and etiology associated with death. Results: no yet available Conclusions: Postmortem studies can help identify major pathogens contributing to respiratory-associated deaths in children. This information is needed to develop evidence-based prevention and treatment policies that target important causes of pediatric respiratory mortality and assist with prioritization of local resources. PRESS can also provide insights into the interpretation of results using multi-pathogen testing platforms in resource-limited settings.

  • Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 Comprehensive Adolescent Research and Engagement Studies (CARES) Study

    Date Submitted: Apr 19, 2018

    Open Peer Review Period: Apr 21, 2018 - May 5, 2018

    Background: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and...

    Background: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies due to challenges in identification and adherence to cART. Objective: Adolescent Trials Network 147: Comprehensive Adolescent Research and Engagement Studies: Acute HIV Infection in Youth is a longitudinal strategic prospective treatment study aimed to identify and promptly treat with cART recently diagnosed youth aged 12 to 24 years of age in Los Angeles and New Orleans who have acute, recent or established HIV infection, as determined by Fiebig stages I to VI on HIV-1 antibody western blot. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to ART are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time and correlate this data with duration of viral suppression. Methods: A total of 72 youth (36 acutely infected and 36 treatment naïve controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to standard of care HIV-1 management and followed for a period of two years. Assessments are conducted at specific time points throughout these two years of follow-up for monitoring of adherence to ART, virus load, magnitude of HIV reservoirs and presence of co-infections. Results: The study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of February 8, 2018, a total of 11 youth were enrolled, 3 with recently acquired and 8 with established HIV infection as determined by Fiebig staging. Recruitment and enrollment are ongoing. Conclusions: We hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, i.e., those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies. Clinical Trial: On June 20th, 2017, the protocol was registered with clinicaltrials.gov (NCT03205696)

  • Fertility among female survivors of childhood, adolescent and young adult cancer: design, methods and cohort characteristics of two pan-European studies (PanCareLIFE)

    Date Submitted: Apr 19, 2018

    Open Peer Review Period: Apr 21, 2018 - May 5, 2018

    Background: Despite a significant number of studies on female fertility following childhood, adolescent, and young adult (CAYA) cancer, studies establishing precise (dose-related) estimates of treatme...

    Background: Despite a significant number of studies on female fertility following childhood, adolescent, and young adult (CAYA) cancer, studies establishing precise (dose-related) estimates of treatment-related risks are still scarce. Previous studies have been under-powered, did not include detailed treatment information, or were based on self-report only without any hormonal assessments. More precise assessments of who is at risk for sub- or infertility are needed. Objective: The objective of this paper is to describe the design and methods of two studies on female fertility (a cohort study and a nested case-control study) among female survivors of CAYA cancer performed within the European PanCareLIFE project. Methods: For the cohort study, which aims to evaluate the overall risk of fertility impairment, as well as the risk for specific subgroups of female CAYA cancer survivors, 13 institutions from 9 countries provide data on fertility impairment. Survivors are defined as being fertility impaired if they meet at least one of eight different criteria based on self-reported and/or hormonal data. For the nested case-control study, which aims to identify specific treatment-related risk factors associated with fertility impairment in addition to possible dose-response relationships, cases (fertility impaired survivors) are selected from the cohort study and matched to controls (survivors without fertility impairment) on a 1:2 basis. Results: Of the 10,998 survivors invited for the cohort study, data are available from 6,650 survivors, either questionnaire-based only (n=5,003), hormonal-based only (n=74), or both (n=1,573). For the nested case-control study, a total of 450 cases and 882 controls are identified. Conclusions: Results of both PanCareLIFE fertility studies will provide detailed insight into the risk of fertility impairment following CAYA cancer and diagnostic- or treatment-related factors associated with an increased risk. This will help clinicians to adequately counsel both girls and young women who are about to start anti-cancer treatment, as well as adult female CAYA cancer survivors, concerning future parenthood, and to timely refer them for fertility preservation. Ultimately, we aim to empower patients and survivors and improve their quality of life.

  • A real-world pragmatic randomized controlled trial of varenicline and bupropion for long-term smoking cessation (MATCH study): study protocol

    Date Submitted: Apr 19, 2018

    Open Peer Review Period: Apr 21, 2018 - May 5, 2018

    Background: Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, an...

    Background: Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. Objective: The primary objective of this study is to evaluate the real-world long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers, utilizing web-based recruitment and follow-up. Genotypic and phenotypic predictors of cessation will also be explored. Methods: Design: This is a two-group parallel block randomized (1:1) open label clinical trial. Setting: The study will be conducted online, with baseline enrolment via the study’s website and follow-up by email. Medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Participants: Individuals who smoke 10 or more cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario, by word-of-mouth and through the internet. Interventions: Eligible participants will receive an email with a prescription for 12-weeks of assigned medication and a letter to take to their physician. Recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. Results: Measurements: The primary outcome measure is smoking status at 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted via email at 4, 8, 12, 26 and 52 weeks after start of treatment to assess point smoking prevalence and continuous smoking abstinence. Mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Personality characteristics will be assessed using the Big Five Aspect Scales. Conclusions: Comments: To our knowledge, this is the first randomized controlled trial to mass-distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost-effective with quit outcomes that are comparable to published clinical trials. Clinical Trial: Trial Registration: www.clinicaltrials.gov ClinicalTrials.gov Identifier: NCT02146911

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