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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:

  • 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.

  • Source: Getty Images; Copyright: Getty Images; URL: https://www.gettyimages.com/license/478186083; License: Licensed by the authors.

    Comparison of Online Survey Recruitment Platforms for Hard-to-Reach Pregnant Smoking Populations: Feasibility Study

    Abstract:

    Background: Recruiting hard-to-reach populations for health research is challenging. Web-based platforms offer one way to recruit specific samples for research purposes, but little is known about the feasibility of online recruitment and the representativeness and comparability of samples recruited through different Web-based platforms. Objective: The objectives of this study were to determine the feasibility of recruiting a hard-to-reach population (pregnant smokers) using 4 different Web-based platforms and to compare participants recruited through each platform. Methods: A screener and survey were distributed online through Qualtrics Panel, Soapbox Sample, Reddit, and Amazon Mechanical Turk (mTurk). Descriptive statistics were used to summarize results of each recruitment platform, including eligibility yield, quality yield, income, race, age, and gestational age. Results: Of the 3847 participants screened for eligibility across all 4 Web-based platforms, 535 were eligible and 308 completed the survey. Amazon mTurk yielded the fewest completed responses (n=9), 100% (9/9) of which passed several quality metrics verifying pregnancy and smoking status. Qualtrics Panel yielded 14 completed responses, 86% (12/14) of which passed the quality screening. Soapbox Sample produced 107 completed surveys, 67% (72/107) of which were found to be quality responses. Advertising through Reddit produced the highest completion rate (n=178), but only 29.2% (52/178) of those surveys passed the quality metrics. We found significant differences in eligibility yield, quality yield, age, number of previous pregnancies, age of smoking initiation, current smokers, race, education, and income (P<.001). Conclusions: Although each platform successfully recruited pregnant smokers, results varied in quality, cost, and percentage of complete responses. Moving forward, investigators should pay careful attention to the percentage yield and cost of online recruitment platforms to maximize internal and external validity.

  • ACPTalk logo. Source: Image created by 360 South; Copyright: The Authors; URL: www.acptalk.com.au; License: Creative Commons Attribution (CC-BY).

    A Website Supporting Sensitive Religious and Cultural Advance Care Planning (ACPTalk): Formative and Summative Evaluation

    Abstract:

    Background: Advance care planning (ACP) promotes conversations about future health care needs, enacted if a person is incapable of making decisions at end-of-life that may be communicated through written documentation such as advance care directives. To meet the needs of multicultural and multifaith populations in Australia, an advance care planning website, ACPTalk, was funded to support health professionals in conducting conversations within diverse religious and cultural populations. ACPTalk aimed to provide religion-specific advance care planning content and complement existing resources. Objective: The purpose of this paper was to utilize the context, input, process, and product (CIPP) framework to conduct a formative and summative evaluation of ACPTalk. Methods: The CIPP framework was used, which revolves around 4 aspects of evaluation: context, input, process, and product. Context: health professionals’ solutions for the website were determined through thematic analysis of exploratory key stakeholder interviews. Included religions were determined through an environmental scan, Australian population statistics, and documentary analysis of project steering committee meeting minutes. Input: Project implementation and challenges were examined through documentary analysis of project protocols and meeting minutes. Process: To ensure religion-specific content was accurate and appropriate, a website prototype was built with content review and functionality testing by representatives from religious and cultural organizations and other interested health care organizations who completed a Web-based survey. Product: Website analytics were used to report utilization, and stakeholder perceptions were captured through interviews and a website survey. Results: Context: A total of 16 key stakeholder health professional (7 general practitioners, 2 primary health nurses, and 7 palliative care nurses) interviews were analyzed. Website solutions included religious and cultural information, communication ideas, legal information, downloadable content, and Web-based accessibility. Christian and non-Christian faiths were to be included in the religion-specific content. Input: Difficulties gaining consensus on religion-specific content were overcome by further state and national religious organizations providing feedback. Process: A total of 37 content reviewers included representatives of religious and cultural organizations (n=29), health care (n=5), and community organizations (n=3). The majority strongly agree or agree that the content used appropriate language and tone (92%, 34/37), would support health professionals (89%, 33/37), and was accurate (83%, 24/29). Product: Resource usage within the first 9 months was 12,957 page views in 4260 sessions; majority were (83.45%, 3555/4260) from Australia. A total of 107 Australian-based users completed the website survey; most felt information was accurate (77.6%, 83/107), easy to understand (82.2%, 88/107), useful (86.0%, 92/107), and appropriate (86.0%, 92/107). A total of 20 nurses (general practice n=10, palliative care n=8, and both disciplines n=2) participated in stakeholder interviews. Qualitative findings indicated overall positivity in relation to accessibility, functionality, usefulness, design, and increased knowledge of advance care planning. Recommended improvements included shortened content, a comparable website for patients and families, and multilingual translations. Conclusions: The CIPP framework was effectively applied to evaluate the development and end product of an advance care planning website.Although overall findings were positive, further advance care planning website development should consider the recommendations derived from this study.

  • Clinical practice guidelines in print form versus mobile apps. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e105/; License: Creative Commons Attribution (CC-BY).

    Comparing a Mobile Decision Support System Versus the Use of Printed Materials for the Implementation of an Evidence-Based Recommendation: Protocol for a...

    Abstract:

    Background: The distribution of printed materials is the most frequently used strategy to disseminate and implement clinical practice guidelines, although several studies have shown that the effectiveness of this approach is modest at best. Nevertheless, there is insufficient evidence to support the use of other strategies. Recent research has shown that the use of computerized decision support presents a promising approach to address some aspects of this problem. Objective: The aim of this study is to provide qualitative evidence on the potential effect of mobile decision support systems to facilitate the implementation of evidence-based recommendations included in clinical practice guidelines. Methods: We will conduct a qualitative study with two arms to compare the experience of primary care physicians while they try to implement an evidence-based recommendation in their clinical practice. In the first arm, we will provide participants with a printout of the guideline article containing the recommendation, while in the second arm, we will provide participants with a mobile app developed after formalizing the recommendation text into a clinical algorithm. Data will be collected using semistructured and open interviews to explore aspects of behavioral change and technology acceptance involved in the implementation process. The analysis will be comprised of two phases. During the first phase, we will conduct a template analysis to identify barriers and facilitators in each scenario. Then, during the second phase, we will contrast the findings from each arm to propose hypotheses about the potential impact of the system. Results: We have formalized the narrative in the recommendation into a clinical algorithm and have developed a mobile app. Data collection is expected to occur during 2018, with the first phase of analysis running in parallel. The second phase is scheduled to conclude in July 2019. Conclusions: Our study will further the understanding of the role of mobile decision support systems in the implementation of clinical practice guidelines. Furthermore, we will provide qualitative evidence to aid decisions made by low- and middle-income countries’ ministries of health about investments in these technologies.

  • Ms Seblewongel Goa, a health extension worker in Wormuma Health Post, in Southern Nations, Nationalities, and Peoples' Region in Ethiopia. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e99/; License: Creative Commons Attribution (CC-BY).

    Universal Versus Conditional Third Day Follow-Up Visit for Children With Nonsevere Unclassified Fever at the Community Level in Ethiopia: Protocol for a...

    Abstract:

    Background: Under the World Health Organization’s integrated community case management strategy, febrile children seen by community health workers (on day 1) without a diagnosable illness and without danger signs are advised to return on day 3, regardless of symptom resolution. This advice might be unnecessary and place additional time and cost burdens on caregivers and community health workers. However, the safety of not following up with respect to children with unclassified fever is unknown. Objective: The objective of this study is to establish the safety of conditional follow-up of nonsevere unclassified fever, that is, nonsevere illness with fever, no malaria, pneumonia, diarrhea, or danger signs, compared with universal follow-up on day 3, through a 2-arm cluster randomized controlled noninferiority trial. Methods: The study is being conducted in 3 districts in southwest Ethiopia. A total of 25 health facilities are randomized to one of the 2 intervention arms; all 144 health posts and 284 community health workers are included. All enrolled children are followed-up after 1 week (on day 8) for re-assessment. If still sick on day 8, additional follow-up takes place after 2 weeks (day 15) and 1 month (day 29). To demonstrate that there is no significant increase in the percentage of children deteriorating clinically, the sample size needed for a noninferiority margin of 4%, a power of 80%, an alpha of 5%, and a design effect of 3 is 4284 children with unclassified fever. Main outcome is treatment failure on day 8, defined as death, hospitalization, one or more danger signs, or persistent fever. Results: The project was funded in 2015 and enrollment was completed 2016. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. Conclusions: This study addresses the question as to whether there is any benefit in recommending universal follow-up among children seen for nonsevere unclassified fever, or whether parents can be counseled to return in the event of persistent fever, using a cluster randomized controlled trial design embedded in a national program. Outcomes will be relevant for policy makers and are important for the evaluation of current and future World Health Organization guidelines for the management of children with fever. Trial Registration: ClinicalTrials.gov NCT02926625; https://clinicaltrials.gov/ct2/show/NCT02926625 (Archived by WebCite at http://www.webcitation.org/6xrQWn50t)

  • Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/4/e95; License: Creative Commons Attribution (CC-BY).

    Recruitment of Participants and Delivery of Online Mental Health Resources for Depressed Individuals Using Tumblr: Pilot Randomized Control Trial

    Abstract:

    Background: Adolescents and young adults frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among young people and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit, and intervene with young people at risk for depression. Objective: The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants and to deliver the intervention of online depression resources. Methods: This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term “#depress”. Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to an intervention of online mental health resources delivered via a Tumblr message, while control participants did not receive resources. Postintervention online surveys assessed resource access and usefulness and control groups were asked whether they would have liked to receive resources. Analyses included t tests. Results: A total of 25 participants met eligibility criteria. The mean age of the participants was 17.5 (SD 1.9) and 65% were female with average score on the Patient Health Questionnaire-9 of 17.5 (SD 5.9). Among the 11 intervention participants, 36% (4/11) reported accessing intervention resources and 64% (7/11) felt the intervention was acceptable. Among the 14 control participants, only 29% (4/14) of reported that receiving resources online would be acceptable (P=.02). Participants suggested anonymity and ease of use as important characteristics in an online depression resource. Conclusions: The intervention was appropriately targeted to young people at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media approach was acceptable, and about a third utilized the online resources. Participants who had not experienced the intervention were less likely to find it acceptable. Future studies should explore this approach in larger samples. Social media may be an appropriate platform for online depression interventions for young people.

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    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

  • Student Activity and Sport Study Ireland (SASSI): an online survey and environmental audit tool for assessing the role of multiple factors for university student physical activity.

    Date Submitted: Apr 19, 2018

    Open Peer Review Period: Apr 20, 2018 - May 4, 2018

    Background: A growing number of individuals spend early adulthood (i.e. 18 – 24 years old) in a university setting, a setting associated with engagement in behaviours that diminish health such as hi...

    Background: A growing number of individuals spend early adulthood (i.e. 18 – 24 years old) in a university setting, a setting associated with engagement in behaviours that diminish health such as high levels of physical inactivity. Increasing physical activity (PA) is a key element of health promotion strategies in many countries but a better understanding of students’ PA behaviours and how they are influenced by personal, behavioural and environmental factors is needed. A number of studies provide protocols to collect information regarding these factors separately; however, none have developed a validated systematic approach to gather information pertaining to all across a whole country. Objective: The purpose of this paper is to present a protocol that allows for the examination of students’ PA and how it is influenced by personal, behavioural and environmental factors. Methods: Student Activity and Sport Study Ireland (SASSI) is a university based cross-sectional study that was carried out across the island of Ireland in 2014. A novel and comprehensive online environmental audit tool gathered information pertaining to the environment provided by universities for PA. An online student survey collected information about the PA beliefs, attitudes, motivations and behaviours of students. The audit tool and student survey were developed through rigorous consultation processes involving international experts. An institutional champion volunteered at each university to recruit, administer and ensure the completion of both assessments . Results: Data collection was undertaken between May and December 2014. Thirty-three universities (80% response rate) completed the environmental audit tool, while 8,122 students (49.1% male; 23.17 ± 6.75 years) completed the student survey (88.3% response rate). Studies are currently underway using the data collected using this protocol. Conclusions: SASSI provides a novel and comprehensive protocol for systematically assessing the PA behaviours of students and the influence of personal, behavioural, and ‘actual’ environmental factors. The strengths of the SASSI study are presented and include high response rates and a unique dataset that can provide information to relevant stakeholders and policymakers, along with aiding the development of university environments and interventions that promote PA involvement. The weaknesses of the protocol are recognised with suggestions given to overcome them in future research. The current protocol is applicable for other countries and has great potential to create harmonisation of data, which would allow for direct comparisons across nations.

  • Using an mHealth App to Transition Care of Type-1 Diabetes from Parents to Teens: Protocol for a Pilot Study

    Date Submitted: Apr 17, 2018

    Open Peer Review Period: Apr 19, 2018 - May 3, 2018

    Background: Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age and parents have to take on the responsibility of T1D man...

    Background: Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age and parents have to take on the responsibility of T1D management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1D. In fact, approximately three-quarters of adolescents are not achieving ADA HbA1c targets. This lack of adherence can lead to negative health outcomes, such as the development of diabetic ketoacidosis, increased infections, and hospitalizations. Objective: The goals of this interdisciplinary proposal are: (1) to develop a unique and theory-driven technology using a mobile phone application (app) to promote self-management behaviors for adolescents aged 10 to 15 years with T1D and their parents; and (2) to explore the feasibility and impact of the self-management mobile app. Methods: This study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In phase two, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management. Results: The pilot test was launched in September 2017. Data collection is underway and results are forthcoming. Conclusions: Adolescents with type 1 diabetes and their parents often struggle during the transition from parent care to adolescent self-management. This transition to young adulthood is challenging for all families, but families facing the added complexity of diabetes management often find this time especially challenging. The proposed intervention aims to shift diabetes management responsibility to the adolescent and increase their independence, while encouraging parents to remain engaged and supportive of their adolescent in an effort to ease some difficulties of this challenging time. Clinical Trial: ClinicalTrials.gov Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens Identifier: NCT03436628 https://clinicaltrials.gov/ct2/show/NCT03436628

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