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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 2017: 4.671).

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.

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

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

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

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

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

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

Studies whose protocols or grant 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:

  • Adolescent Medicine Trials Network logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/3/e12050/; License: Licensed by JMIR.

    Improving the Youth HIV Prevention and Care Continuums: The Adolescent Medicine Trials Network for HIV/AIDS Interventions

    Abstract:

    Background: Epidemiologic and clinical information in the United States indicate that HIV transmission and acquisition among adolescents and young adults (youth) remain unchanged, without improvement. Interventions to prevent HIV transmission among youth are critically needed, as are interventions to improve adherence to all components of the continuum of care for youth living with HIV. Objective: The primary mission of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) is to conduct both independent and collaborative research that explores promising behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected and at-risk youth aged between 12 and 24. Methods: Through the ATN, the National Institutes of Health is supporting HIV interventional research for youth in the United States. Results: The ATN comprises 3 cooperative multiproject research programs and a coordinating center. Each program is led by a network hub and has well-defined research themes to assist, guide, and coordinate HIV research project activities. Conclusions: ATN activities encompass the full spectrum of research needs for youth, from HIV primary prevention for at-risk youth in the community to secondary and tertiary prevention with clinical management of HIV infection among youth living with HIV experiencing adherence challenges. International Registered Report Identifier (IRRID): DERR1-10.2196/12050

  • Untitled. Source: Wikimedia Commons; Copyright: Sarah Johnson; URL: https://commons.wikimedia.org/wiki/File:Have_you_tried_quit_smoking.jpg; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Mobile Phone–Based Smoking-Cessation Intervention for Patients Undergoing Elective Surgery: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)–based interventions can help individuals quit smoking. Objective: The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. Methods: A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change–enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments’ current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. Results: Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. Conclusions: Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. Trial Registration: ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008 International Registered Report Identifier (IRRID): PRR1-10.2196/12511

  • Source: Pixabay; Copyright: StockSnap; URL: https://pixabay.com/en/running-shoes-footwear-lace-bench-2558673/; License: Public Domain (CC0).

    Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2...

    Abstract:

    Background: Worldwide incidence of type 2 diabetes (T2D) is rapidly increasing. Given the numerous negative health consequences associated with T2D, prevention of this disease has become a priority. Lifestyle changes, including regular exercise, can reduce the onset of T2D in those at elevated risk. However, long-term adherence to exercise is often poor in this population. Existing lifestyle interventions targeting exercise are labor intensive and costly for staff and participants. Evidence-informed counseling delivered in a manner that reduces dependence on staff and facilitates self-regulatory skills could alleviate time and financial barriers while promoting independent exercise. Objective: This protocol outlines the design, recruitment, and proposed analysis of a brief, 2-week evidence-informed exercise counseling intervention combined with either high-intensity interval training (HIIT) or traditional moderate-intensity continuous training (MICT). Methods: Small Steps for Big Changes is a 2-arm randomized controlled trial that will examine the effectiveness of combining brief exercise counseling with HIIT or MICT on adherence to moderate and vigorous exercise over 1 year. Cardiorespiratory fitness will be assessed at baseline, post intervention (2 weeks), and at 6- and 12-month follow-up. Physical activity behavior will be examined at baseline, post intervention, and 3-, 6-, 9-, and 12-month follow-up. The impact of the intervention on psychosocial outcomes pertinent to exercise adherence will be examined. Results: Data collection was complete in March 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: The results of this brief intervention have the potential to inform future public health efforts designed to increase exercise in individuals at risk of T2D. Trial Registration: ClinicalTrials.gov NCT02164474; https://clinicaltrials.gov/ct2/show/NCT02164474 (Archived by WebCite at http://www.webcitation.org/74Hx1ipj6) International Registered Report Identifier (IRRID): DERR1-10.2196/11226

  • Nurse taking patient blood pressure. Source: iStock by Getty Images; Copyright: AndreyPopov; URL: https://www.istockphoto.com/ca/photo/doctor-measuring-patients-blood-pressure-gm600414086-103273631; License: Licensed by the authors.

    Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: Protocol for the Multicenter Randomized Hypertension and...

    Abstract:

    Background: Medication nonadherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient’s ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies. Objective: The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat. Methods: The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients’ adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients’ prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes. Results: This study was funded by the National Heart, Lung, and Blood Institute. Enrollment and follow-up are ongoing and data analysis is expected to begin in late 2020. Planned enrollment is 1130 patients. On the basis of evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes. Conclusions: The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition—hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB). International Registered Report Identifier (IRRID): DERR1-10.2196/12498

  • A digital education course. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/3/e12488/; License: Creative Commons Attribution (CC-BY).

    Digital Education for the Management of Chronic Wounds in Health Care Professionals: Protocol for a Systematic Review by the Digital Health Education...

    Abstract:

    Background: Digital education is “the act of teaching and learning by means of digital technologies.” Digital education comprises a wide range of interventions that can be broadly divided into offline digital education, online digital education, digital game-based learning, massive open online courses (MOOCs), psychomotor skills trainers, virtual reality environments, virtual patient simulations, and m-learning. Chronic wounds pose an immense economic and psychosocial burden to patients and the health care system, as caring for them require highly specialized personnel. Current training strategies face significant barriers, such as lack of time due to work commitments, distance from provider centers, and costs. Therefore, there is an increased need to synthesize evidence on the effectiveness of digital education interventions on chronic wounds management in health care professionals. Objective: Our main objective is to assess the effectiveness of digital education as a stand-alone approach or as part of a blended-learning approach in improving pre- and postregistration health care professionals’ knowledge, attitudes, practical skills, and behavior in the management of chronic wounds, as well as their satisfaction with the intervention. Secondary objectives are to evaluate patient-related outcomes, cost-effectiveness of the interventions, and any unfavorable or undesirable outcomes that may arise. Methods: This systematic review will follow the methodology as described in the Cochrane Handbook for Systematic Reviews of Interventions. As our systematic review is one of a series of reviews on digital education for health professionals’ education, we will use a previously developed search strategy. This search includes the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library), MEDLINE (Ovid), Embase (Ovid), Web of Science, the Educational Resource Information Centre (ERIC) (Ovid), PsycINFO (Ovid), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO), the ProQuest Dissertation and Theses database, and trial registries. Databases will be searched for studies published from January 1990 to August 2018. Two independent reviewers will screen the library for included studies. We will describe the screening process using a flowchart as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will extract the data using a previously developed, structured data extraction form. Included studies will be quality-assessed using the Risk of Bias tool from Cochrane. We will narratively summarize the data and, if possible, we will conduct a meta-analysis. We will use Cochrane’s RevMan 5.3 software for data analysis. Results: We have completed the screening of titles and abstracts for this systematic review and are currently selecting papers against our inclusion and exclusion criteria through full-text revision. We are expecting to complete our review by the end of April 2019. Conclusions: This systematic review will provide an in-depth analysis of digital education strategies to train health care providers in the management of chronic wounds. We consider this topic particularly relevant given the current challenges facing health care systems worldwide, including shortages of skilled personnel and a steep increase in the population of older adults as a result of a prolonged life expectancy. Trial Registration: PROSPERO CRD42018109971; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=109971 International Registered Report Identifier (IRRID): DERR1-10.2196/12488

  • The ePATH mobile app (montage). Source: The Authors / Placeit; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/3/e11625/; License: Licensed by the authors.

    Enhanced Patient Activation in Cancer Care Transitions: Protocol for a Randomized Controlled Trial of a Tailored Electronic Health Intervention for Men With...

    Abstract:

    Background: Prostate cancer has increased in incidence worldwide and is the leading cause of cancer death in 24 countries. The most common treatment is radical prostatectomy. However, surgery is associated with postoperative complications such as urinary incontinence and sexual dysfunction, causing decreased quality of life. If survivors are encouraged to be more active in self-care management, the symptom burden may decrease and quality of life may improve. An electronic health (eHealth) intervention based on motivational behavioral theory has been developed for this purpose. Objective: This study aimed to compare the effectiveness of standard care in combination with a tailored eHealth and mobile health self-management support system, electronic Patient Activation in Treatment at Home (ePATH), with standard care of adverse effects of prostate cancer treatment (urinary incontinence and sexual functioning) in men undergoing radical prostatectomy. The secondary aim was to test the effect on patient activation, motivation, overall well-being, and health literacy over time in and between groups. Methods: A pragmatic multicenter, block-randomized controlled trial with 2 study arms, standard care (control) and eHealth-assisted standard care (intervention), for patients undergoing radical prostatectomy. For 80% power, a sample of 242 men will need to be recruited. Results: Recruitment started in January 2018 and is expected to be completed by August 2019. Data collection will be completed in August 2020. The first cross-sectional results from this trial are anticipated to be published in January 2020. Conclusions: With the increasing number of prostate cancer survivors, attention should be paid to rehabilitation, psychosocial care, and support for endurance of self-care to reduce suffering from adverse treatment effects, poor quality of life, and depression because of postoperative complications. This project may increase knowledge of how patients can be supported to feel involved in their care and returning to as normal a life as possible. The anticipated effects of ePATH could improve health outcomes for individuals and facilitate follow-up for health care professionals. Trial Registration: International Standard Randomised Controlled Trial Number: 18055968; http://www.isrctn.com/ISRCTN18055968 (Archived by WebCite at http://www.isrctn.com/ISRCTN18055968). International Registered Report Identifier (IRRID): DERR1-10.2196/11625

  • Source: Rawpixel; Copyright: Teddy Rawpixel; URL: https://www.rawpixel.com/image/416807/senior-adults-giving-high-five; License: Licensed by JMIR.

    A Self-Regulation–Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention “MyPlan 2.0” targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective: The aim of this paper is to thoroughly describe “MyPlan 2.0” and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behavior. Methods: A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients’ stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted. Results: The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019. Conclusions: This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time. International Registered Report Identifier (IRRID): DERR1-10.2196/12413

  • Smartphone and wheelchair user. Source: Pixabay; Copyright: Steve Buissinne; URL: https://pixabay.com/photos/wheelchair-disability-injured-749985/; License: Creative Commons Attribution (CC-BY).

    Smartphone-Delivered Peer Physical Activity Counseling Program for Individuals With Spinal Cord Injury: Protocol for Development and Pilot Evaluation

    Abstract:

    Background: Leisure-time physical activity (LTPA) is a critical component of a healthy lifestyle for individuals with spinal cord injury (SCI). However, most individuals are not sufficiently active to accrue health benefits. The Active Living Lifestyles program for individuals with SCI who use manual wheelchairs (ALLWheel) targets important psychological factors that are associated with LTPA uptake and adherence while overcoming some barriers associated with participation restrictions. Objective: The goal of the paper is to describe the protocol for the development and evaluation of the ALLWheel program for individuals with SCI who use manual wheelchairs. Methods: The first three stages of the Medical Research Council framework for developing and evaluating complex interventions (ie, preclinical, modeling, exploratory) are described. The preclinical phase will consist of scoping and systematic reviews and review of theory. The intervention will be modeled by expert opinions and consensus through focus groups and Delphi surveys with individuals with SCI, clinicians, and community partners. Finally, the feasibility and potential influence of the ALLWheel program on LTPA and psychological outcomes will be evaluated. Results: This project is funded by the Craig H Neilsen Foundation, the Fonds de Recherche du Québec–Santé, and the Canadian Disability Participation Project and is currently underway. Conclusions: Using peer trainers and mobile phone technology may help to cultivate autonomy-supportive environments that also enhance self-efficacy. Following a framework for developing and evaluating a novel intervention that includes input from stakeholders at all stages will ensure the final product (ie, a replicable intervention) is desirable to knowledge users and ready for evaluation in a randomized controlled trial. If effective, the ALLWheel program has the potential to reach a large number of individuals with SCI to promote LTPA uptake and adherence. International Registered Report Identifier (IRRID): RR1-10.2196/10798

  • The ATN CARES study logo. Source: ATN CARES; Copyright: ATN CARES; URL: http://www.researchprotocols.org/2019/2/e10795/; License: Creative Commons Attribution (CC-BY).

    Community-Based, Point-of-Care Sexually Transmitted Infection Screening Among High-Risk Adolescents in Los Angeles and New Orleans: Protocol for a...

    Abstract:

    Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents aged 15-24 years. Gay, bisexual, and transgender youth (GBTY), homeless youth, and youth with histories of drug use, mental health disorders, and incarceration are all at uniquely high risk for STIs. However, these adolescents often lack access to sexual health services. Objective: This study aims to use point-of-care STI tests in community-based settings to screen for and treat STIs in adolescents. Methods: We are recruiting 1500 HIV-uninfected youth and 220 HIV-infected youth from homeless shelters, GBTY organizations, and community health centers in Los Angeles, California and New Orleans, Louisiana. Study participants will receive STI screening every 4 months for 24 months. STI screening includes rapid HIV, syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae, and Hepatitis C virus testing. Trained paraprofessionals will conduct all STI testing. When a participant screens positive for an STI, they are either linked to a partner medical clinic or provided with same-day antibiotic therapy and expedited partner therapy. We will monitor STI prevalence among study participants as well as point-of-care test performance, linkage to care, and treatment outcomes. Results: The project was funded in 2016, and enrollment will be completed in 2019. Preliminary data analysis is currently underway. Conclusions: As STI rates continue to rise, it is important to improve access to screening and treatment services, particularly for high-risk adolescents. In this study, we aim to evaluate the use of point-of-care STI diagnostic tests in community-based organizations. We hope to determine the prevalence of STIs among these adolescents and evaluate the acceptability and feasibility of community-based STI screening and treatment. Trial Registration: ClinicalTrials.gov NCT03134833; https://clinicaltrials.gov/ct2/show/NCT03134833 International Registered Report Identifier (IRRID): DERR1-10.2196/10795

  • Source: Rawpixel; Copyright: Rawpixel; URL: https://www.rawpixel.com/image/379838/closeup-mobile-phone-showing-recipe-screen; License: Licensed by JMIR.

    The Effects of Positive Affect and Episodic Future Thinking on Temporal Discounting and Healthy Food Demand and Choice Among Overweight and Obese...

    Abstract:

    Background: Unhealthy behaviors (eg, poor food choices) contribute to obesity and numerous negative health outcomes, including multiple types of cancer and cardiovascular and metabolic diseases. To promote healthy food choice, diet interventions should build on the dual-system model to target the regulation and reward mechanisms that guide eating behavior. Episodic future thinking (EFT) has been shown to strengthen regulation mechanisms by reducing unhealthy food choice and temporal discounting (TD), a process of placing greater value on smaller immediate rewards over larger future rewards. However, these interventions do not target the reward mechanisms that could support healthy eating and strengthen the impact of EFT-anchored programs. Increasing positive affect (PosA) related to healthy food choices may target reward mechanisms by enhancing the rewarding effects of healthy eating. An intervention that increases self-regulation regarding unhealthy foods and the reward value of healthy foods will likely have a greater impact on eating behavior compared with interventions focused on either process alone. Objective: This study aimed to introduce a protocol that tests the independent and interactive effects of EFT and PosA on TD, food choice, and food demand in overweight and obese adults. Methods: This protocol describes a factorial, randomized, controlled pilot study that employs a 2 (affective imagery: positive, neutral) by 2 (EFT: yes, no) design in which participants are randomized to 1 of 4 guided imagery intervention arms. In total, 156 eligible participants will complete 2 lab visits separated by 5 days. At visit 1, participants complete surveys; listen to the audio guided imagery intervention; and complete TD, food demand, and food choice tasks. At visit 2, participants complete TD, food demand, and food choice tasks and surveys. Participants complete a daily food frequency questionnaire between visits 1 and 2. Analyses will compare primary outcome measures at baseline, postintervention, and at follow-up across treatment arms. Results: Funding notification was received on April 27, 2017, and the protocol was approved by the institutional review board on October 6, 2017. Feasibility testing of the protocol was conducted from February 21, 2018, to April 18, 2018, among the first 32 participants. As no major protocol changes were required at the end of the feasibility phase, these 32 participants were included in the target sample of 156 participants. Recruitment, therefore, continued immediately after the feasibility phase. When this manuscript was submitted, 84 participants had completed the protocol. Conclusions: Our research goal is to develop novel, theory-based interventions to promote and improve healthy decision-making and behaviors. The findings will advance decision-making research and have the potential to generate new neuroscience and psychological research to further understand these mechanisms and their interactions. Trial Registration: ISRCTN Registry ISRCTN11704675; http://www.isrctn.com/ISRCTN11704675 (Archived by WebCite at http://www.webcitation.org/760ouOoKG) International Registered Report Identifier (IRRID): DERR1-10.2196/12265

  • Source: Eglin Air Force Base (Samuel King Jr); Copyright: US Air Force; URL: https://www.eglin.af.mil/News/Article-Display/Article/391747/medical-group-recognized-for-newborn-hearing-procedures/; License: Public Domain (CC0).

    Genetic Determinants of Ototoxicity During and After Childhood Cancer Treatment: Protocol for the PanCareLIFE Study

    Abstract:

    Background: Survival rates after childhood cancer now reach nearly 80% in developed countries. However, treatments that lead to survival and cure can cause serious adverse effects with lifelong negative impacts on survivor quality of life. Hearing impairment is a common adverse effect in children treated with cisplatin-based chemotherapy or cranial radiotherapy. Ototoxicity can extend from high-tone hearing impairment to involvement of speech frequencies. Hearing impairment can impede speech and language and neurocognitive development. Although treatment-related risk factors for hearing loss following childhood cancer treatment have been identified, the individual variability in toxicity of adverse effects after similar treatment between childhood cancer patients suggests a role for genetic susceptibility. Currently, 12 candidate gene approach studies have been performed to identify polymorphisms predisposing to platinum-induced ototoxicity in children being treated for cancer. However, results were inconsistent and most studies were underpowered and/or lacked replication. Objective: We describe the design of the PanCareLIFE consortium’s work packages that address the genetic susceptibility of platinum-induced ototoxicity. Methods: As a part of the PanCareLIFE study within the framework of the PanCare consortium, we addressed genetic susceptibility of treatment-induced ototoxicity during and after childhood cancer treatment in a large European cohort by a candidate gene approach and a genome-wide association screening. Results: This study included 1124 survivors treated with cisplatin, carboplatin, or cranial radiotherapy for childhood cancer, resulting in the largest clinical European cohort assembled for this late effect to date. Within this large cohort we defined a group of 598 cisplatin-treated childhood cancer patients not confounded by cranial radiotherapy. The PanCareLIFE initiative provided, for the first time, a unique opportunity to confirm already identified determinants for hearing impairment during childhood cancer using a candidate gene approach and set up the first international genome-wide association study of cisplatin-induced direct ototoxicity in childhood cancer patients to identify novel allelic variants. Results will be validated in an independent replication cohort. Patient recruitment started in January 2015 and final inclusion was October 2017. We are currently performing the analyses and the first results are expected by the end of 2019 or the beginning of 2020.  Conclusions: Genetic factors identified as part of this pan-European project, PanCareLIFE, may contribute to future risk prediction models that can be incorporated in future clinical trials of platinum-based therapies for cancer and may help with the development of prevention strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/11868

  • Patient weight is recorded during a peer education visit in Phnom Penh. Source: Image created by the Authors; Copyright: Annette L Fitzpatrick; URL: https://www.researchprotocols.org/2019/3/e11614/; License: Creative Commons Attribution (CC-BY).

    Using Targeted mHealth Messages to Address Hypertension and Diabetes Self-Management in Cambodia: Protocol for a Clustered Randomized Controlled Trial

    Abstract:

    Background: Hypertension and diabetes represent the first and third highest contributors to global disability. While mobile health (mHealth) messaging programs have rapidly increased in low- and middle-income countries (LMIC), adaptations for specific patient health needs is a new approach to manage chronic conditions. Objective: The primary aim of this study is to develop and test an mHealth communication intervention using electronic data capture (by tablet) and voice messaging to improve hypertension and diabetes self-management in Cambodia. The secondary aim is to share results with the Cambodian Ministry of Health and development partners to inform health policy and develop strategies for hypertension and diabetes control. Methods: The study design is a cluster randomized controlled clinical trial randomizing each of 75 Community peer educators (PEs), trained and coordinated by MoPoTsyo Patient Information Center in Phnom Penh, into one of 3 groups of 25 (approximately 60 patients each) to receive either tablet+messages, tablet only, or no intervention (control). The total sample within each group includes 25 clusters and approximately 1500 patients located in 7 Operational Districts in rural regions or urban slums in Cambodia. The interventions (groups 1 and 2) were compared with usual PE monitoring without the tablet or mHealth messaging interventions. Focus groups and informant interviews were conducted to develop messages according to specific themes—medications adherence, laboratory testing, physician visits, obesity, smoking, and general lifestyle issues. Using the data received at monthly PE monitoring meetings, patients will receive specific messages based on their individual health challenges. Following the intervention completion, clinical and process outcomes will be compared with baseline metrics between groups. Results: PEs were randomized in July 2017, and the intervention was implemented in September 2017 through June 2018. Analyses are underway. Conclusions: This project is unique in its combination of electronic data transfer, which can be accessed immediately, with voice messages most relevant to individual patients’ needs. Positive results will indicate the value of using targeted messaging in patient-specific, self-management issues to improve hypertension and diabetes control. International Registered Report Identifier (IRRID): DERR1-10.2196/11614

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    Open Peer Review Period: Mar 26, 2019 - Apr 9, 2019

    Background: The burden of poverty-related infectious diseases remains high in low- and middle-income countries, while non-communicable diseases are rapidly gaining importance. To countermeasure this d...

    Background: The burden of poverty-related infectious diseases remains high in low- and middle-income countries, while non-communicable diseases are rapidly gaining importance. To countermeasure this dual disease burden, the KaziBantu project aims at improving and promoting health literacy as a means for a healthy and active lifestyle. The project implements a school-based health intervention package, consisting of physical education, moving-to-music and health- and nutrition education lessons from the KaziKidz toolkit. It is complemented by the KaziHealth workplace health intervention program for teachers. Objective: The goal of the KaziBantu project is to assess the impact of a school-based health intervention package on risk factors for non-communicable diseases (NCDs), health behaviors and psychosocial health in primary schoolchildren in disadvantaged communities in Port Elizabeth, South Africa. Additionally, we aim to test a workplace health intervention for teachers. Methods: A randomized controlled trial will be conducted in eight schools. Approximately 1,000 grade 4-6 schoolchildren, aged 9-13 years, and approximately 60 teachers will be recruited during a baseline survey in early 2019. For schoolchildren, the study is designed as a 9-month cluster-randomized controlled trial (KaziKidz intervention), while for teachers, a 6-month intervention phase (KaziHealth intervention) is planned. After randomization, four of the eight schools will receive the education program, while the other schools will serve as the control group. Intervention schools are further randomized to the different combinations of two additional intervention components, teacher workshops and teacher coaching. Results: This study builds on local evidence and offers the possibility of providing new evidence on health intervention responses to non-communicable disease risk factors in school settings as a basis for future controlled studies that will enable comparisons amongst marginalized communities between South Africa and other African countries. Conclusions: The KaziKidz teaching material is a holistic educational and instructional tool designed for primary school teachers in low-resource settings and it is in line with South Africa’s Curriculum and Assessment Policy Statement (CAPS). The ready-to-use lessons and assessments within KaziKidz should facilitate the use and implementation of the teaching material. Furthermore, the KaziHealth interventions should empower teachers to take care of their health through knowledge gains regarding disease risk factors, physical activity, fitness, psychosocial health and nutrition indicators. Teachers as role models will be able to promote better health behaviors and encourage a healthy, active and inspiring environment for children at school. We conjecture that improved health and wellbeing increase teachers’ productivity with trickle down effects on the children they teach and train. Clinical Trial: www.isrctn.com; identifier: ISRCTN18485542 (date assigned: 11 July 2018).

  • Féminas: A Longitudinal Cohort Study Integrating Gender-Affirming Primary Care and Peer Navigation with HIV Treatment and Prevention Services to Improve the Health of Transgender Women

    Date Submitted: Mar 21, 2019

    Open Peer Review Period: Mar 26, 2019 - Apr 9, 2019

    Background: Public health strategies are urgently needed to improve HIV disparities among transgender women, including holistic intervention approaches that address those health needs prioritized by t...

    Background: Public health strategies are urgently needed to improve HIV disparities among transgender women, including holistic intervention approaches that address those health needs prioritized by the community. Hormone therapy is the primary way many transgender women medically achieve gender identity affirmation. Peer navigation has shown to be effective to engage and retain underserved populations living with HIV in stable, primary medical care. Objective: To assess the acceptability and effectiveness of an integrated innovative HIV service delivery model designed to improve HIV care cascade, by combining gender-affirming primary care and peer navigation with HIV treatment and prevention services. Specifically, we aim to assess at the end of the intervention, the 1) proportion of HIV negative participants who undergo regular HIV testing and linkage to preventive services; and the 2) proportion of HIV positive participants who link to and are retained in care, adhere to antiretroviral treatment and result in viral suppression. Methods: A 12-month, non-randomized, single-arm, cohort study was implemented in Lima, Peru among adult individuals, assigned a male sex at birth, who identified themselves as male-to-female transgender, regardless of initiation or completion of gender enhancement procedures, and who were unaware of their HIV serostatus or were living with HIV but not linked in routine HIV care. HIV positive participants were indicated to initiate standard antiretroviral treatment and underwent quarterly plasma HIV-1 RNA and peripheral CD4+ lymphocyte cell count monitoring. HIV negative participants received quarterly HIV testing and risk reduction counseling. All participants received feminizing hormone therapy supply on a monthly basis and adherence counseling and education on their use. Peer health navigation facilitated retention in care by outreach work, social media, and phone contact. Results: Patient recruitment started in October 2016 and final inclusion was March 2017. The cohort ended follow-up on March 2018. Data analysis is currently underway. Conclusions: Innovative and culturally sensitive strategies to improve the HIV care cascade among transgender women are vital to curb the burden of HIV morbidity and mortality for this key population and prevent HIV transmission to their sexual partners. Findings of this intervention will inform future policies and research, including evaluation of its efficacy in a randomized controlled trial. Clinical Trial: The study is registered at Peru National Institute of Health (Registro Nacional de Investigaciones en Salud EI00000345) and Clinicaltrials.gov (Registration Number: NCT03757117).

  • Spinal Cord Injury Veterans: Disability Benefits, Outcomes and Healthcare Utilization

    Date Submitted: Mar 16, 2019

    Open Peer Review Period: Mar 19, 2019 - Apr 2, 2019

    Spinal cord injury (SCI) is among the most devastating and disabling medical conditions affecting wounded members of the military. Veterans Affairs Healthcare System (VA) is the single largest SCI hea...

    Spinal cord injury (SCI) is among the most devastating and disabling medical conditions affecting wounded members of the military. Veterans Affairs Healthcare System (VA) is the single largest SCI healthcare provider in the nation. The Veterans Benefits Administration (VBA) offers financial compensation for disabilities sustained or re-aggravated during military service, this is called a “service connected” disability. Since the cost of living with an SCI can be overwhelming for SCI Veterans and their families, this monthly financial compensation provided to service-connected SCI Veterans can assist with access to supportive resources (e.g., assistive devices, personal aide) to help them sustain their functional independence, participate in their home life, employment, and social activities that might otherwise be inaccessible and maintain positive quality of life (QOL). Despite VA’s efforts to reduce the financial burden associated with successful rehabilitation, independent living and community integration through disability benefits, some SCI Veterans have non-service connected disabilities because their disabilities were not incurred or aggravated by their military service. Little is known about the impact of having additional financial resources provided to service-connected SCI Veterans with non-service connected SCI-Veterans who do not have these additional financial resources. This project will address this gap by gathering information from SCI Veterans, their family caregivers and SCI clinicians about the impact of this monetary compensation on their health and functioning as well as access to assistive devices/resources, medical care and rehabilitation. Study Design: This qualitative study will use a community-based approach to derive information from SCI Veterans, family caregivers and SCI clinicians about their day-to-day experiences with being service-connected or non-service connected. Of particular interest is how these groups independently interpret the reasons and impact of service-connection or non-service connected compensation on SCI Veterans health status, functional outcomes, quality of life and healthcare utilization. We will collaborate with a Community Advisory Board in all phases of the project. The two study sites are: East Orange Campus of Veterans Administration New Jersey Healthcare System (VANJHCS) and Kessler Institute for Rehabilitation/Kessler Foundation. We will collect qualitative data from: chart review, semi-structured interviews and focus groups. Triangulation of these data sources will allow us to compare, contrast and integrate the results set of practice and policy recommendations about the impact of service-connected and non-service connected SCI Veterans to clinical and policy guidelines, family interventions, caregiver training and patient education programs. Impact: The result will highlight services provided by VA disability benefits to a potential underutilized source of care and access to care SCI Veterans. Study findings will be used to generate a set of practice recommendations to the clinical guidelines, family interventions, caregiver training and patient education programs that can be tested in future large-scale multi-site quantitative study to devise targeted community-based interventions.

  • Effectiveness of a walking program involving the Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton suit for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation: Study protocol for a randomized controlled trial

    Date Submitted: Mar 13, 2019

    Open Peer Review Period: Mar 18, 2019 - Apr 1, 2019

    Background: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy,...

    Background: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, representing a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. Objective: This study aims to clarify the effectiveness and safety of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. Methods: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes pre-intervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and post-intervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for pre-intervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly tests assessing the 10-m maximum walking speed, MWS). Patients with MWS of 30–60 m/min and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary endpoint is the change in MWS from baseline to the end of the 5-week intervention. Results: This study began in November 2016 and is being conducted at 15 participating facilities in Japan. Conclusions: Assessments of walking ability vary greatly, and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce additional recovery of walking ability, which would promote the use of HAL technology in the clinical setting. Clinical Trial: This study has been registered with the University Hospital Medical Information Network (UMIN trial registration number: UMIN000024805).

  • Behavioural, nutritional and genetic risk factors of colorectal cancers in Morocco: Protocol for a multi-centre case-control study

    Date Submitted: Mar 12, 2019

    Open Peer Review Period: Mar 15, 2019 - Mar 29, 2019

    Background: Colorectal cancer (CRC) has been reported as the third most commonly diagnosed cancer worldwide and is currently considered as a major public health concern. In Morocco, the incidence of C...

    Background: Colorectal cancer (CRC) has been reported as the third most commonly diagnosed cancer worldwide and is currently considered as a major public health concern. In Morocco, the incidence of CRC increased significantly in the last years. At the same time data (e.g. food balance sheets) demonstrate a change of the typical traditional Moroccan diet to a Westernized diet among the Moroccan population. Objective: we present the protocol of a large-scale Moroccan case-control study that aims at investigating associations of diets, other lifestyle factors and genetic factors with CRC risk in Morocco. Methods: A case-control study conducted between 2009 and 2017 and including 3032 case-control pairs (1516 cases/1516 controls) matched on sex, age and centre in five major public health hospitals in Morocco. Questionnaires on socio-demographic data, lifestyle, family history of CRC and non-steroidal anti-inflammatory drugs were completed by trained investigators during face-to-face interviews. In addition, participants completed a semi-quantitative food-frequency questionnaire, developed to assess food intake in the Moroccan population. Information regarding genetic factors was recorded for cases; and paraffin blocks (with embedded tumour tissues) are available in 3 collaborating hospitals. Conditional logistic regression analysis are planned to assess the association between diet and CRC risk. Binary logistic regression is considered to predict the association between mutations and nutritional risk factors including only CRC case series. Results: All together, 2906 cases and controls (1453 cases and 1453 controls) were considered eligible and included in our study. Both cases and controls did not differ significantly with respect to sex (p=0.51), centre (p=1.00) marital status (p=0.36), alcohol intake (p=0.12), and NSAID use (p=0.95). However, participants in the control group were significantly more physically active and more likely to be never smokers and to have a higher education level than cases. Conclusions: This is the first study investigating potential risk factors of CRC risk such as nutrition, lifestyle and genetic factors, originating from a southern Mediterranean country with low but increasing CRC prevalence. Identified risk factors will allow the establishment of evidence based preventive actions regarding nutrition and other lifestyle habits adapted to the Moroccan context. In brief, this study will promote cancer research and prevention in Morocco. Clinical Trial: Our study is not clinical trial

  • Older People with Type 2 diabetes - Individualising Management wIth a SpecialisEd community team: Safety and feasibility study (OPTIMISES): protocol

    Date Submitted: Mar 12, 2019

    Open Peer Review Period: Mar 15, 2019 - Mar 29, 2019

    Background: The prevalence of diabetes is rising in older people. Clinical guidelines recommend that diabetes management should be individualised, however, there is limited information regarding the...

    Background: The prevalence of diabetes is rising in older people. Clinical guidelines recommend that diabetes management should be individualised, however, there is limited information regarding the current management patterns of diabetes in older people. Few individuals achieve optimal glycaemic levels in the general population which could potentially lead to adverse health outcomes and impact quality of life. Objective: To trial individualised diabetes management intervention for older people through home visits with a credentialed diabetes educator and telehealth consultations with an endocrinologist located at a tertiary hospital. Methods: This paper describes the design and methodology of a mixed methods feasibility and safety study to identify the current management of people 65 years or older with type 2 diabetes. We will implement and evaluate a personalised approach to management in the community of an Australian metropolitan city. This management approach will utilise flash glucose monitoring and home visits with the support of a community home nursing service credentialed diabetes educator and telehealth consultation with an endocrinologist located at a local tertiary hospital. Results: Not reported Conclusions: This study is the first of its kind to explore individualised diabetes management for community dwelling older people, aimed to achieve optimal glycaemic levels. The data drawn from this project may be used to inform policy makers, service providers, clinicians and older adults living with diabetes. Clinical Trial: Australian Clinical Trial Registration: ACTRN12617000350325

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