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Journal Description


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

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine, and their peer-review reports, if available (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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

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

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

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

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

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

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

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

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

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

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

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


Recent Articles:

  • Woman standing near man while carrying smartphone. Source: Pexels; Copyright: mentatdgt; URL:; License: Licensed by JMIR.

    Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial


    Background: Obesity is among the most significant health challenges facing today’s adolescents. Weight gain during adolescence is related to cardiovascular disease, type 2 diabetes, and some cancers in later life. Presently, adolescents living in Australia have limited access to age-appropriate obesity prevention services. Objective: This study aims to investigate whether a two-way text message program, with optional telephone health counseling, improves body mass index (BMI) z score and lifestyle outcomes in adolescents who are overweight. Methods: This study will be a single-blind randomized controlled trial (N=150) comparing a two-way text message intervention, with optional telephone health counseling, to usual care in adolescents (13-18 years old, inclusive) who are overweight (recruited from a pediatric weight management clinic and the broader community in Sydney, Australia). The intervention group will receive a six-month text message program, which consists of two-way, semipersonalized, lifestyle-focused text messages (four messages/week) in addition to usual care. The control group will be assigned to receive usual care. The study also includes a follow-up at 12-months. The primary outcome is a change in BMI z score at six months. Secondary outcomes are changes in waist-to-height ratio, diet, physical and sedentary activity levels, sleep quality, quality of life, self-esteem, self-efficacy, social support, and eating disorder and depression symptoms. Also, we will examine acceptability, utility, and engagement with the program through a study-specific process evaluation questionnaire, semi-structured telephone interviews, and an analysis of health counselor communication logs. The analyses will be performed by the intention-to-treat principle to assess differences between intervention and control groups. Results: The study opened for recruitment in December 2019. Data collection is expected to be completed by December 2021, and the results for the primary outcome are expected to be published in early 2022. Conclusions: This study will test the effectiveness of an interactive two-way text message program compared to usual care in improving BMI z score and lifestyle outcomes in adolescents with overweight. This interactive, innovative, and scalable project also aims to inform future practice and community initiatives to promote obesity prevention behaviors for adolescents. Clinical Trial: Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000389101;

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    Nonclinical Sexual Health Support for HIV, Viral Hepatitis, and Other Sexually Transmitted Infections in Gay, Bisexual, and Other Men Who Have Sex With Men:...


    Background: The term “community health worker” (CHW) can apply to a wide range of individuals providing health services and support for diverse populations. Very little is known about the role of CHWs in Europe working in nonclinical settings who promote sexual health and prevent HIV and other sexually transmitted infections (STIs) among gay, bisexual, and other men who have sex with men (MSM). Objective: This paper describes the development and piloting of the first European Community Health Worker Online Survey (ECHOES) as part of the broader European Union-funded ESTICOM (European Surveys and Trainings to Improve MSM Community Health) project. The questionnaire aimed to assess the knowledge, attitudes, and practices of CHWs providing sexual health services to gay, bisexual, and other MSM in European settings. Methods: ECHOES comprises three superordinate domains divided into 10 subsections with 175 items (routed) based on a scoping exercise and literature review, online prepiloting, and Europe-wide consultation. Additional piloting and cognitive debriefing interviews with stakeholders were conducted to identify comprehension issues and improve the clarity, intelligibility, accessibility, and acceptability of the survey. Psychometric properties, including internal consistency of the standardized scales used as part of the survey were examined. The final survey was available to 33 countries in 16 languages. Results: Recruitment closed on January 31, 2018. Data from 1035 CHWs were available for analysis after application of the exclusion criteria. The findings of the ECHOES survey and the wider ESTICOM project, are now available from the ESTICOM website and/or by contacting the first author. Conclusions: The findings of this survey will help characterize, for the first time, the diverse role of CHWs who provide sexual health services to gay, bisexual, and other MSM in Europe. Importantly, the data will be used to inform the content and design of a dedicated training program for CHWs as part of the larger ESTICOM project and provide recommendations for MSM-specific strategies to improve sexual health in general and to reduce the incidence and prevalence of HIV, viral hepatitis, and other STIs in particular.

  • Source: FlickR; Copyright: a b; URL:; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Preferences for Sun Protection With a Self-Monitoring App: Protocol of a Discrete Choice Experiment Study


    Background: The incidence of sun-exposure-related skin conditions, such as melanoma, is a gradually increasing and largely preventable public health problem. Simultaneously, the availability of mobile apps that enable the self-monitoring of health behavior and outcomes is ever increasing. Inevitably, recent years have seen an emerging volume of electronic patient-generated health data (PGHD), as well as their targeted application across primary prevention areas, including sun protection and skin health. Despite their preventive potential, the actual impact of these apps relies on the engagement of health care consumers, who are primarily responsible for recording, sharing, and using their PGHD. Exploring preferences is a key step toward facilitating consumer engagement and ultimately realizing their potential. Objective: This paper describes an ongoing research project that aims to elicit the preferences of health care consumers for sun protection via app-based self-monitoring. Methods: A discrete choice experiment (DCE) will be conducted to explore how healthy consumers choose between two alternative preventive self-monitoring apps. DCE development and attribute selection were built on extensive qualitative work, consisting of the secondary use of a previously conducted scoping review, a rapid review of reviews, 13 expert interviews, and 12 health care consumer interviews, the results of which are reported in this paper. Following D-optimality criteria, a fractional factorial survey design was generated. The final DCE will be administered in the waiting room of a travel clinic, targeting a sample of 200 participants. Choice data will be analyzed with conditional logit and multinomial logit models, accounting for individual participant characteristics. Results: An ethics approval was waived by the Ethics Committee Zurich. The study started in September 2019 and estimated data collection and completion is set for January 2020. Five two-level attributes have been selected for inclusion in the DCE, addressing (1) data generation methods, (2) privacy control, (3) data sharing with general practitioner, (4) reminder timing, and (5) costs. Data synthesis, analysis, and reporting are planned for January and February 2020. Results are expected to be submitted for publication by February 2020. Conclusions: Our results will target technology developers, health care providers, and policy makers, potentially offering some guidance on how to design or use sun-protection-focused self-monitoring apps in ways that are responsive to consumer preferences. Preferences are ultimately linked to engagement and motivation, which are key elements for the uptake and success of digital health. Our findings will inform the design of person-centered apps, while also inspiring future preference-eliciting research in the field of emerging and complex eHealth services.

  • Source: Image created by the authors; Copyright: The authors; URL:; License: Creative Commons Attribution (CC-BY).

    Evaluation of a Rural Emergency Medical Service Project in Germany: Protocol for a Multimethod and Multiperspective Longitudinal Analysis


    Background: German emergency medical services are a 2-tiered system with paramedic-staffed ambulances as the primary response, supported by prehospital emergency doctors for life-threatening conditions. As in all European health care systems, German medical practitioners are in short supply, whereas the demand for timely emergency medical care is constantly growing. In rural areas, this has led to critical delays in the provision of emergency medical care. In particular, in cases of cardiac arrest, time is of the essence because, with each passing minute, the chance of survival with good neurological outcome decreases. Objective: The project has 4 main objectives: (1) reduce the therapy-free interval through widespread reinforcement of resuscitation skills and motivating the public to provide help (ie, bystander cardiopulmonary resuscitation), (2) provide faster professional first aid in addition to rescue services through alerting trained first aiders by mobile phone, (3) make more emergency physicians available more quickly through introducing the tele-emergency physician system, and (4) enhance emergency care through improving the cooperation between statutory health insurance on-call medical services (German: Kassenärztlicher Bereitschaftsdienst) and emergency medical services. Methods: We will evaluate project implementation in a tripartite prospective and intervention study. First, in medical evaluation, we will assess the influences of various project measures on quality of care using multiple methods. Second, the economic evaluation will mainly focus on the valuation of inputs and outcomes of the different measures while considering various relevant indicators. Third, as part of the work and organizational analysis, we will assess important work- and occupational-related parameters, as well as network and regional indexes. Results: We started the project in 2017 and will complete enrollment in 2020. We finished the preanalysis phase in September 2018. Conclusions: Overall, implementation of the project will entail realigning emergency medicine in rural areas and enhancing the quality of medical emergency care in the long term. We expect the project to lead to a measurable increase in medical laypersons’ individual motivation to provide resuscitation, to strengthen resuscitation skills, and to result in medical laypersons providing first aid much more frequently. Furthermore, we intend the project to decrease the therapy-free interval in cases of cardiac arrest by dispatching first aiders via mobile phones. Previous projects in urban regions have shown that the tele-emergency physician system can provide a higher availability and quality of emergency call-outs in regular health care. We expect a closer interrelation of emergency practices of statutory health insurance physicians with the rescue service to lead to better coordination of rescue and on-call services.

  • Source: Tired of Cancer BV; Copyright: Tired of Cancer BV; URL:; License: Licensed by the authors.

    Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial


    Background: Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. Objective: The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. Methods: The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. Results: Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. Conclusions: This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF. Trial Registration: Netherlands Trial Register NL6642;

  • Source: Image created by the Authors; Copyright: The Authors; URL:; License: Licensed by JMIR.

    Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a...


    Background: Elderly people are at particular high risk for postoperative delirium (POD) following spine surgery, which is associated with longer hospital stays, higher costs, risk for delayed complications, long-term care dependency, and cognitive dysfunction (POCD). It is insufficiently understood which mechanisms and risk factors contribute to the development of POD and POCD following these major but plannable surgeries. Objective: This study aims to identify modifiable risk factors in spine surgery. A better understanding thereof would help adapt medical management and surgical strategies to individual risk profiles. Methods: This is a single-center observational study jointly conducted by the departments of neurosurgery, neurology, and anesthesiology at a tertiary care hospital in Germany. All patients aged 60 years and older presenting to the neurosurgery outpatient clinic or ward for elective spine surgery are screened for eligibility. Exclusion criteria include presence of neurodegenerative or history of psychiatric disease and medication with significant central nervous system activity (eg, antidepressants, antipsychotics, sedatives). Surgical and anesthetic procedures including duration of surgery as primary end point of this study are thoroughly documented. All patients are furthermore evaluated for their preoperative cognitive abilities by a number of tests, including the Consortium to Establish a Registry for Alzheimer's Disease Plus test battery. Physical, mental, and social health and well-being are assessed using the Patient-Reported Outcome Measurement Information System Profile 29 and Hospital Anxiety and Depression Scale. Patients additionally receive preoperative cerebrovascular ultrasound and structural and functional brain imaging. The immediate postoperative period includes screening for POD using the Nursing Delirium Screening Scale and validation through Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, criteria. We furthermore investigate markers of (neuro)inflammation (eg, interleukins, C-reactive protein, tumor necrosis factor alpha). Preoperative examinations are repeated 3 months postoperatively to investigate the presence of POCD and its mechanisms. Statistical analyses will compare delirious and nondelirious patients for predictors of immediate (POD) and delayed (POCD) cognitive dysfunction. Results: This is the first study to prospectively evaluate risk factors for POD and POCD in spine surgery. Recruitment is ongoing, and data collection is estimated to be finished with the inclusion of 200 patients by mid-2020. Conclusions: The identification of mechanisms, possibly common, underlying POD and POCD would be a major step toward defining effective interventional strategies early in or even before the postoperative period, including the adaptation of surgical strategies to individual risk profiles. Trial Registration: NCT03486288;

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    Impact of Geriatric Hotlines on Health Care Pathways and Health Status in Patients Aged 75 Years and Older: Protocol for a French Multicenter Observational...


    Background: In France, emergency departments (EDs) are the fastest and most common means for general practitioners (GPs) to cope with the complex issues presented by elderly patients with multiple conditions. EDs are overburdened, and studies show that being treated in EDs can have a damaging effect on the health of elderly patients. Outpatient care or planned hospitalizations are possible solutions if appropriate geriatric medical advice is provided. In 2013, France’s regional health authorities proposed creating direct telephone helplines, “geriatric hotlines,” staffed by geriatric specialists to encourage interactions between GP clinics and hospitals. These hotlines are designed to improve health care pathways and the health status of the elderly. Objective: This study aims to describe the health care pathways and health status of patients aged 75 years and older hospitalized in short-stay geriatric wards following referral from a geriatric hotline. Methods: The study will be conducted over 24 months in seven French university hospital centers. It will include all patients aged 75 and older, living in their own homes or nursing homes, who are admitted to short-stay geriatric wards following hotline consultation. Two questionnaires will be filled out by medical staff at specific time points: (1) after conducting the telephone consultation and (2) on admitting the patient to a short-stay geriatric medical care. The primary endpoint will be mean hospitalization duration. The secondary endpoints will be intrahospital mortality rate, the characteristics of patients admitted via the hotline, and the types of questions asked and responses given via the hotline. Results: The study was funded by the National School for Social Security Loire department (École Nationale Supérieure de Sécurité Sociale) and the Conference for funders of prevention of autonomy loss for the elderly of the Loire department in November 2017. Institutional review board approval was obtained in April 2018. Data collection started in May 2018; the planned end date for data collection is May 2020. Data analysis will take place in the summer of 2020, and the first results are expected to be published in late 2020. Conclusions: The results will reveal whether geriatric hotlines provide the most effective management of elderly patients, as indicated by shorter mean hospitalization durations. Shorter hospital durations could lead to a reduced risk of complications—geriatric syndromes—and the domino chain of geriatric conditions that follow. We will also describe different geriatric hotlines from different cities and compare how they function to improve the health care of the elderly and pave the way toward new advances, especially in the organization of the care path. Trial Registration: NCT03959475;

  • Treating a patient with diabetic retinopathy in South Africa. Source: Flickr; Copyright: Community Eye Health; URL:; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).

    Identifying Barriers and Enablers to Attending Diabetic Retinopathy Screening in Immigrants to Canada From Ethnocultural Minority Groups: Protocol for a...


    Background: Immigrants to Canada belonging to ethnocultural minority groups are at increased risk of developing diabetes and complications, including diabetic retinopathy, and they are also less likely to be screened and treated. Improved attendance to retinopathy screening (eye tests) has the potential to reduce permanent complications, including blindness. Objective: This study aims to identify the barriers and enablers of attending diabetic retinopathy screening among ethnocultural minority immigrants living with diabetes in Quebec and Ontario, Canada, to inform the development of a behavior change intervention to improve diabetic retinopathy screening attendance. Methods: The research question draws on the needs of patients and clinicians. Using an integrated knowledge translation approach, the research team includes clinicians, researchers, and patient partners who will contribute throughout the study to developing and reviewing materials and procedures, helping to recruit participants, and disseminating findings. Using a convenience snowball strategy, we will recruit participants from three target groups: South Asian and Chinese people, and French-speaking people of African descent. To better facilitate reaching these groups and support participant recruitment, we will partner with community organizations and clinics serving our target populations in Ontario and Quebec. Data will be collected using semistructured interviews, using topic guides developed in English and translated into French, Mandarin, Hindi, and Urdu, and conducted in those languages. Data collection and analysis will be structured according to the Theoretical Domains Framework (TDF), which synthesizes predominant theories of behavior change into 14 domains covering key modifiable factors that may operate as barriers or enablers to attending eye screening. We will use directed content analysis to code barriers and enablers to TDF domains, then thematic analysis to define key themes within domains. Results: This study was approved for funding in December 2017, and the research ethics board approved the conduct of the study as of January 13, 2018. Data collection then began in April 2018. As of August 28, 2018, we have recruited 22 participants, and analysis is ongoing, with results expected to be published in 2020. Conclusions: Findings from this study will inform the codevelopment of theory-informed, culturally- and linguistically-tailored interventions to support patients in attending retinopathy screening.

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    Willingness to Seek Help for Depression in Young African American Adults: Protocol for a Mixed Methods Study


    Background: In the United States, among those living with mental illness, 81% of African American (AA) young adults do not seek treatment compared with 66% of their white counterparts. Although the literature has identified unique culturally related factors that impact help seeking among AAs, limited information exists regarding the development and evaluation of interventions that incorporate these unique factors. Objective: This study aims to describe a study protocol designed to develop a culturally relevant, theory-based, psychoeducational intervention for AA young adults; to determine if exposure to the intervention impacts AA young adults’ willingness to seek help; and to determine whether cultural factors and stigma add to the prediction of willingness to seek help. Methods: The Theory of Planned Behavior (TPB) and Barrera and Castro’s framework for cultural adaptation of interventions were used as guiding frameworks. In stage 1 (information gathering), a literature review and three focus groups were conducted to identify salient cultural beliefs. Using stage 1 results, the intervention was designed in stage 2 (preliminary adaptation design), and in stage 3 (preliminary adaptation tests), the intervention was tested using pretest, posttest, and 3-month follow-up surveys. An experimental, mixed methods, prospective one-group intervention design was employed, and the primary outcomes were participants’ willingness and intention to seek help for depression and actual help-seeking behavior. Results: This study was funded in May 2016 and approved by the University of Texas at Austin institutional review board. Data were collected from November 2016 to March 2016. Of the 103 students who signed up to participate in the study, 70 (67.9%) completed the pre- and posttest surveys. The findings are expected to be submitted for publication in 2020. Conclusions: The findings from this research are expected to improve clinical practice by providing empirical evidence as to whether a culturally relevant psychoeducational intervention is useful for improving help seeking among young AAs. It will also inform future research and intervention development involving the TPB and willingness to seek help by identifying the important factors related to willingness to seek help. Advancing this field of research may facilitate improvements in help-seeking behavior among AA young people and reduce the associated mental health disparities that apparently manifest early on.

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    Exploring Drivers of Work-Related Stress in General Practice Teams as an Example for Small and Medium-Sized Enterprises: Protocol for an Integrated...


    Background: An increasing shortage of skilled personnel, including medical personnel, has been reported in many postindustrial economies. Persisting and growing trends in absenteeism and incapacity to work due to mental disorders are concerning and have increased political, economic, and scientific interest in better understanding and management of determinants related to the work environment and health. Objective: This study protocol describes an integrated approach of social research methods to explore determinants of work-related stress in general practice teams as an example for micro, small, and medium-sized enterprises (SMEs). Methods: The methods applied will allow an in-depth exploration of work practices and experiences relating to psychological well-being in general practice teams. An ethnographic approach will be used to develop an in-depth understanding of the drivers of work-related stress in general practice teams. We will combine participating observation and individual interviews with five to seven general practitioners (GPs), and five to seven focus group discussions with the nonphysician staff (3-4 participants per group) in approximately four GP group practices and one single practice in Germany. Data collection and analysis will follow a grounded theory approach. Results: The Ethics Committee of the Medical Faculty, University Hospital of Tuebingen, Germany, has approved this study (reference number: 640/2017BO2). Recruitment has commenced with study completion anticipated in mid-2020. Conclusions: The data from this project will be used in follow-up projects to develop and test an intervention to reduce and prevent work-related stress in GP practices and other SMEs.

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    Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study


    Background: Hepatocellular carcinoma (HCC) is a worldwide health concern because of a continued increase in cases globally; furthermore, the prognosis for patients with HCC remains poor. Transarterial chemoembolization (TACE) has been established as the standard of care for the intermediate stage of HCC; however, no therapeutic agents are available to reduce the high rate of recurrence. Objective: This study aims to evaluate the safety of alpha-fetoprotein (AFP)-derived peptides for patients with HCC post-TACE. Methods: This will be an open-label, single-arm, multicenter study to evaluate the safety of AFP-derived peptides (AFP 357 and AFP 403), which contain histocompatibility antigen-A24-restricted cytotoxic T lymphocyte epitopes from tumor antigens expressed in HCC and is recognized at a high rate by lymphocytes in patients with HCC. Protocol treatment will consist of six courses of the subcutaneous administration of 3 mg each of AFP 357 and AFP 403. A total of 14 patients will be included in this study, the first 6 as a main analysis target group and an additional 8 as an extended cohort from three institutions in Japan. The primary endpoint will be the occurrence of serious adverse events (safety profile). The secondary endpoints will include time to progression, overall survival, completion rate, and adverse events (efficacy profile). Results: We have recruited 14 patients with HCC as of December 2019. The final follow-up will be completed by March 2020. Conclusions: In this study, we will evaluate the safety profile of AFP-derived peptides for patients with HCC post-TACE. We believe that this study will provide useful information and will help to design a subsequent phase II trial based on the results. Trial Registration: Japan Registry of Clinical Trials jRCTs041180155;

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    Measuring the Effects of Sharing Mobile Health Data During Diabetes Consultations: Protocol for a Mixed Method Study


    Background: There is rising demand for health care’s limited resources. Mobile health (mHealth) could be a solution, especially for those with chronic illnesses such as diabetes. mHealth can increases patients’ options to self-manage their health, improving their health knowledge, engagement, and capacity to contribute to their own care decisions. However, there are few solutions for sharing and presenting patients’ mHealth data with health care providers (HCPs) in a mutually understandable way, which limits the potential of shared decision making. Objective: Through a six-month mixed method feasibility study in Norway, we aim to explore the impacts that a system for sharing patient-gathered data from mHealth devices has on patients and HCPs during diabetes consultations. Methods: Patients with diabetes will be recruited through their HCPs. Participants will use the Diabetes Diary mobile phone app to register and review diabetes self-management data and share these data during diabetes consultations using the FullFlow data-sharing system. The primary outcome is the feasibility of the system, which includes HCP impressions and expectations (prestudy survey), usability (System Usability Scale), functionalities used and data shared during consultations, and study-end focus group meetings. Secondary outcomes include a change in the therapeutic relationship, patient empowerment and wellness, health parameters (HbA1c and blood pressure), and the patients’ own app-registered health measures (blood glucose, medication, physical activity, diet, and weight). We will compare measures taken at baseline and at six months, as well as data continuously gathered from the app. Analysis will aim to explain which measures have changed and how and why they have changed during the intervention. Results: The Full Flow project is funded for 2016 to 2020 by the Research Council of Norway (number 247974/O70). We approached 14 general practitioner clinics (expecting to recruit 1-2 general practitioners per clinic) and two hospitals (expecting to recruit 2-3 nurses per hospital). By recruiting through the HCPs, we expect to recruit 74 patients with type 2 and 33 patients with type 1 diabetes. Between November 2018 and July 2019, we recruited eight patients and 15 HCPs. During 2020, we aim to analyze and publish the results of the collected data from our patient and HCP participants. Conclusions: We expect to better understand what is needed to be able to share data. This includes potential benefits that sharing patient-gathered data during consultations will have on patients and HCPs, both individually and together. By measuring these impacts, we will be able to present the possibilities and challenges related to a system for sharing mHealth data for future interventions and practice. Results will also demonstrate what needs to be done to make this collaboration between HCPs and patients successful and subsequently further improve patients’ health and engagement in their care.

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  • Guided Internet-Based Cognitive Behavioral Therapy for Japanese Patients with Obsessive-Compulsive Disorder: A Protocol of the Randomized Controlled Trial

    Date Submitted: Feb 12, 2020

    Open Peer Review Period: Feb 12, 2020 - Apr 8, 2020

    Background: Cognitive behavioral therapy (CBT) for obsessive-compulsive disease (OCD) has been established, but access to CBT in Japan is limited. Internet-based cognitive behavioral therapy (ICBT) ma...

    Background: Cognitive behavioral therapy (CBT) for obsessive-compulsive disease (OCD) has been established, but access to CBT in Japan is limited. Internet-based cognitive behavioral therapy (ICBT) may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. Because there are few randomized controlled trials, it is necessary to examine the effectiveness of ICBT in patients with OCD. We designed a randomized controlled trial (RCT) protocol between guided ICBT and the control group in Japanese patients with OCD. Objective: We reported a protocol for a randomized controlled trial of ICBT in Japanese patients with OCD. Methods: RCT comprised two parallel groups (ICBT and UC) consisting of 15 participants each (n=30) diagnosed with OCD. We will evaluate the effectiveness of twelve intervention weeks. The primary outcome of symptoms’ severity will be the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Secondary outcomes include the Obsessive-Compulsive Inventory (OCI), Beck Anxiety Inventory (BAI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Working Alliance Inventory-Short Form (WAI-SF), and quality of life in Euro Qol-5D. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance (ANCOVA) with the change in total outcomes' scores at week 12. All comparisons are planned, and all P values will be two-sided. P values < 0.05 will be considered statistically significant. Results: The study will be implemented from January 2020 to March 2021, and results are expected to be available in mid-2021. Conclusions: The protocol suggested that the way to reduce nonbeneficial invasive treatments for OCD patients, and a systematic approach to improve access to CBT in Japan. Clinical Trial: UMIN: 000044422

  • The THRIVE Study: Protocol for a longitudinal case-control study on the role of stress and genital immunity in sexual trauma and HIV susceptibility among adolescent girls and adult women

    Date Submitted: Feb 12, 2020

    Open Peer Review Period: Feb 10, 2020 - Apr 6, 2020

    Background: The relationship between sexual violence and HIV risk has been extensively documented through social and behavioral research; by contrast, the explanatory underlying biological mechanisms...

    Background: The relationship between sexual violence and HIV risk has been extensively documented through social and behavioral research; by contrast, the explanatory underlying biological mechanisms are poorly understood. Objective: The purpose of the THRIVE Study is to examine the impact of sexual trauma on HIV susceptibility through dysregulation of: (a) soluble inflammatory and anti-inflammatory/anti-HIV biomarkers in the female genital tract and (b) the hypothalamic-pituitary-adrenal axis, among adolescent girls and adult women. Methods: The THRIVE study is a longitudinal case-control study conducted in San Diego, California, USA among a racially diverse sample. Cases are adolescent girls (aged 14-19) or adult women (aged 20-45) who have experienced vaginal sexual trauma perpetrated by a male within the past 15 days. Controls are adolescent girls or adult women who have engaged in consensual vaginal sex with a male within the past 15 days. At baseline, 1- and 3-month follow-up study visits, participants undergo: (1) a urine-based pregnancy test, (2) venipuncture blood draw for HIV, C-reactive protein, adrenocorticotropic hormone and progesterone testing, (3) a 45-minute interviewer-administered computer survey, and (4) cervicovaginal lavage to measure pro-inflammatory and anti-inflammatory/anti-HIV soluble immune biomarkers. After each study visit, participants self-collect saliva specimens (upon waking, 30-minutes post-waking, and 45-minutes post-waking) at home for three consecutive days, which is later assayed for cortisol and dehydroepiandrosterone sulfate. Participants receive compensation at each study visit and for the return of saliva specimens, plus a list of local medical and support services. Study procedures utilize trauma-informed care methods, given the sensitive nature of the study and enrollment of women in the acute phase post-sexual trauma. All research staff and investigators adhere to ethical principles and guidelines in the conduct of research activities. Data will be analyzed for descriptive and inferential analysis. Results: Presently, recruitment of participants is ongoing. Publication of first results is expected by late 2021. Conclusions: The THRIVE Study will deliver foundational knowledge on how sexual trauma increases susceptibility to HIV acquisition via alterations in cervicovaginal immune regulation and the psychobiology of the stress responses. Findings will inform future research on mechanistic models of in-vitro and in-vivo injury and cervicovaginal wound healing processes, which may lead to non-vaccine biomedical HIV prevention products for girls and women. Clinical Trial: Not applicable.

  • The Effects of Radiotherapy and Comorbidity on Health-Related Quality Of Life and Mortality among Older Women with Low-Risk Breast Cancer: Proposal For a Retrospective Longitudinal Study

    Date Submitted: Feb 7, 2020

    Open Peer Review Period: Feb 7, 2020 - Apr 3, 2020

    Background: The National Comprehensive Cancer Network Breast Cancer Guidelines Committee has suggested that the omission of adjuvant radiation therapy (RT) after breast-conserving surgery can be a rea...

    Background: The National Comprehensive Cancer Network Breast Cancer Guidelines Committee has suggested that the omission of adjuvant radiation therapy (RT) after breast-conserving surgery can be a reasonable option among older women with low-risk breast cancer (early-stage, ER-positive, and node-negative) if they are treated with endocrine therapy. However, RT usage in this group of women still exceeds 50%. On the other hand, older women tend to forego RT (even when necessary) due to cost, inconvenience, and potential adverse responses associated with RT. Understanding health-related quality of life (HRQOL) change with receipt of RT among older women in the modern era is limited due to the underrepresentation of this population in clinical trials. Objective: The proposed study aims to examine the associations of RT with HRQOL trajectories as well as survival outcomes among older women over 5-10 year follow-up. We will also assess whether pre-diagnosis comorbidity burden influences receipt of RT and whether the associations between RT and HRQOL trajectory and survival outcomes are modified by comorbidity burden. Methods: We will use a retrospective cohort study design with the population-based database of Surveillance, Epidemiology, and End-Results linked to the Medicare Health Outcomes Survey (SEER-MHOS). Older women (65+) diagnosed with low-risk breast cancer in 1998-2014, received BCS, and participated in MHOS 1998-2016 are eligible for the current analysis. The clustering method, latent class analysis, will be used to identify each patient’s pre-diagnosis comorbidity burden, and HRQOL will be evaluated using SF-36/VR-12 scales. The inverse-weighted estimates of the probability of treatment will be included as a covariate to control for treatment selection bias and confounding effects in subsequent analysis. The association of RT with HRQOL trajectory will be evaluated using inverse-weighted semiparametric B-splines models. The inverse-weighted Cox regression model will be used to obtain hazard ratios with 95% confidence intervals for the association of RT with survival outcomes. Differential effects of RT on both outcomes according to comorbidity burden class will also be evaluated. Results: As of January 2020, the study was approved by the institutional review board, and the SEER-MHOS data was obtained from the National Cancer Institute and SEER. Women with low-risk breast cancer who met inclusion and exclusion criteria have been identified, and pre-diagnosis comorbidity burden has been characterized using latent class analysis. Further data analysis will begin in February 2020, and the first manuscript will be submitted in a peer-reviewed journal in June 2020. Conclusions: This research has the potential to improve clinical outcomes of older women with low-risk breast cancer by providing them additional information on the HRQOL trajectories when they make RT treatment-decision. It will facilitate informed, shared treatment decision and cancer care planning and ultimately will improve the HRQOL of older women with breast cancer. Clinical Trial: NA

  • My Understanding of Drug Use Experiences (MiUSE): a protocol for the development of a digitally delivered harm reduction intervention for students in higher education.

    Date Submitted: Jan 15, 2020

    Open Peer Review Period: Jan 15, 2020 - Mar 11, 2020

    Background: Digital interventions have been identified as a possible tool in the reduction of harm from illicit drug use among students attending higher education (i.e. college students). However inte...

    Background: Digital interventions have been identified as a possible tool in the reduction of harm from illicit drug use among students attending higher education (i.e. college students). However intervention success in this area to date has been hampered by a lack of user involvement and behavior change theory in their design. The MiUSE project will combine a rigorous user-centered design methodology, with robust behavioral change theories to develop a digital harm-reduction intervention for illicit drug use among students in higher education. Objective: The objective of this project is to design and develop a digital intervention that targets drug use related harm in higher education students. Methods: The MiUSE project will take place over three phases. The first phase, was exploratory in nature; involving the conduct of three systematic reviews, the administration of a large survey, and the conduct of student workshops to gather a comprehensive evidence base to guide the project. The second phase is the development stage of the project, involving the use of the Behavior Change Wheel theoretical model to determine the behavioral change components of the intervention, and the use of the User Centered Design methodology to guide the development of the digital intervention. The third phase is the evaluation stage, whereby the intervention will undergo a five-stage evaluation process to comprehensively evaluate its impacts. Results: The exploratory phase 1 of the MiUSE project was completed in December 2018. Phase 2 is currently underway, and Phase 3 is due to begin in June 2020. Conclusions: Higher education institutions are ideally placed to intervene and support students in the area of illicit drug use, but are constrained by limited resources. Current digital interventions in this area are sparse, and have several weaknesses. The MiUSE project draws on learnings from previous work, utilizing robust methodologies in an attempt to develop a digital intervention that is economically viable, effective in changing behavior, usable and acceptable to students, and able to sustain long-term implementation in higher education institutions.

  • A Prospective Study Evaluating a Pain Assessment Tool in Postoperative Environment: Protocol for Algorithm Testing and Enhancement

    Date Submitted: Jan 12, 2020

    Open Peer Review Period: Jan 12, 2020 - Mar 8, 2020

    Background: Pain assessment is critical to the optimal treatment of pain. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. Howeve...

    Background: Pain assessment is critical to the optimal treatment of pain. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. However, pain as a multivalent, dynamic, and ambiguous phenomenon is difficult to quantify, particularly when the patient’s ability to communicate is limited. The “gold standard” of pain intensity assessment is self-reporting. However, this unidimensional model is disparaged for its oversimplification and limited applicability in several vulnerable patient populations. Researchers have attempted to develop objective pain assessment tools through analysis of physiological pain indicators, such as Electrocardiography (ECG), Electromyography (EMG), Plethysmography (PPG), and Electrodermal Activity (EDA). However, pain assessment by using only these signals can be unreliable, as there are various other factors that alter these vital signs and the adaptation of vital signs to pain stimulation varies from person to person. Objective pain assessment using behavioral signs such as facial expressions has recently gained attention. Several techniques in this category, such as those using computer vision to extracting features from patients’ head-pose, suffer from feasibility issues in clinical settings due to privacy and practical barriers to deployment. Objective: This paper aims to develop an automatic and versatile pain assessment tool algorithm for detection and assessment of pain in a reliable and objective way in non-communicative patients through observational data collection by wearable technologies, measuring facial EMG, ECG, PPG, and EDA. Methods: This study was planned to be done in three different phases: (1) Evaluation and Test of usability, utility, and accuracy of the new pain assessment tool in 30 healthy working-age volunteers, (2) Further development and research of a pain assessment tool in patients likely experiencing mild to moderate pain, and (3) Conduct a trial to assess the effectiveness of the whole platform in uncommunicative patients at two different sites which serve as the sites of both intervention and control group. Currently available state-of-the-art standard sensors were used to measure bioelectrical EMG signals as well as changes in heart rate, respiratory rate, and oxygen saturation. Based on the results, the pain assessment tool was further developed and reconstituted with modern wearable sensors, devices, and algorithms. In this paper, we focus on the second part of the study. HUMAN RESEARCH PROTECTIONS Application for IRB Review (APP) was approved for this paper. Results: The development of the pain assessment tool is calculated to be ready in early 2020. Preliminary results will be ready for publication from Fall 2019. Conclusions: This paper is about the second phase of research on multimodal signals including facial muscle electrical activity, cardiac electrical activity, and electrodermal activity as indicators of pain. This paper will allow testing the smart pain assessment tool in uncommunicative patients in a multicenter, multinational setting in California/USA and Turku/Finland to promote pain management of patients and enhance the safety and quality of care.