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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:

  • 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 activaftion, 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

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/2/e9228/; License: Creative Commons Attribution (CC-BY).

    Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness, and Chronic Obstructive Pulmonary Disease (MISSION ABC): Protocol for a...

    Abstract:

    Background: A high proportion of the costs for respiratory diseases are generated by a relatively small group of patients with severe disease (recognized or unrecognized) or complex problems that include multimorbidity, at-risk behaviors, and socioeconomic disadvantage. These patients often struggle to engage with the structured, proactive, care approaches for chronic disease management advocated for asthma and chronic obstructive pulmonary disease (COPD), resulting in repeated emergency use of both primary and secondary health care. An integrated approach for the management of complex patients, incorporating both specialist and primary care teams’ expertise, may be effective in improving outcomes for such high-risk patients. However, the evidence is mixed, and there is a need for evaluation of models of integrated care in routine “real-world” clinical settings. Objective: This mixed-methods protocol examines the implementation of a novel integrated care model for patients with airways disease and undifferentiated breathlessness by using both quantitative and qualitative evaluation of processes, patient and health care professional experiences, and clinical outcomes throughout the clinic cycles. It aims to establish whether Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness, and Chronic Obstructive Pulmonary Disease (MISSION ABC), including innovative diagnostic and self-management tools, can deliver improvements in health service use and clinical outcomes for the different patient groups (asthma, breathlessness, and COPD) and compares the 12-month period prior to the first patient visit and the 6-month period following the last visit. Methods: A combination of study designs is required to evaluate all aspects of the service: participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics; before-and-after study for patient outcomes before and after clinic attendance; and qualitative methods (interviews and focus groups). Results: The results will be compiled and published in April 2019. Conclusions: Evaluation of the clinic cycles will include consideration of qualitative data from patients, carers, and health care professionals in addition to quantitative outcomes for service implementation and patient factors. The long-term impact of the service will be evaluated using clinical and health service outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/9228

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

    Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy:...

    Abstract:

    Background: Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. Objective: The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures—HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures—VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. Methods: The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. Results: Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. Conclusions: Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care. Trial Registration: ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). International Registered Report Identifier (IRRID): DERR1-10.2196/11416

  • Source: United States Army Africa (Jonathon Daniell); Copyright: US Army; URL: http://www.usaraf.army.mil/media-room/photo/28893/welcome-to-rwandas-first-medical-readiness-training-exercise; License: Public Domain (CC0).

    Protocol for Investigating the Technical Efficiency of District Hospitals in the Public Health Sector of KwaZulu-Natal, South Africa

    Abstract:

    Background: The central objective of policy makers and health managers is efficiency in the delivery of health care. With frequent reports of global economic crises, there is a need to continuously measure the performance of various sectors of the health care system. This can inform the decision-making process toward allocating scarce resources with the aim of maximizing output. Objective: The aim of this study is to determine the technical efficiency (TE) of public sector district hospitals in the province of KwaZulu-Natal, South Africa to provide information that will assist in policy formulation that may further assist in more efficient resource allocation decisions. Methods: This is a health system research based on a quantitative research approach. All 38 public district hospitals in the 11 municipalities of the province will be included in this study. The data for the study will include inputs from hospitals’ operations that contribute toward subsequent outputs. The input data will include information such as the number of health professionals (doctors, nurses, and other personnel) and number of hospital beds, whereas the output data will include information such as outpatient visits and number of admissions or discharge. Other data categories to be included will be determined by data availability and will be uniform for all facilities. Data for each facility for a 3-year period from 2014 to 2017 will be obtained from databases of the district health information, basic accounting, and personnel salary systems. On the basis of the data obtained, a model will be developed that can be used to assess how TE of public districts hospitals may be improved. TE will be determined using Data Envelopment Analysis, and factors influencing efficiency will be computed using StataCorp statistical package. Results: As of February 2019, the study is at the data collection, data input, and analysis stages. The results are expected to be available from the second quarter of 2019. Conclusions: Findings from this study can add to tools available to policy makers, health planners, and managers in making decisions about resource allocation in health care systems. Moreover, these findings will be disseminated electronically and in print. International Registered Report Identifier (IRRID): DERR1-10.2196/12037

  • Screenshot Moving Stories. Source: Image created by the authors; Copyright: The Authors; License: Licensed by the authors.

    A Game-Based School Program for Mental Health Literacy and Stigma Regarding Depression (Moving Stories): Protocol for a Randomized Controlled Trial

    Abstract:

    Background: The prevalence of elevated depressive symptoms among youth in most western societies is high. Yet, most adolescents who are experiencing depressive symptoms do not seek help. Low mental health literacy, high stigma, and low social support have been shown to hinder help-seeking. A small number of interventions has been developed to target mental health literacy and stigma, but few focus on actual help-seeking and first aid behavior. We have developed a game-based school program called Moving Stories that targets mental health literacy, including knowledge and behavior, and stigma among adolescents, in regard to depression specifically. Objective: Our aim is to describe the protocol for a study that will test the effectiveness of the program Moving Stories in a Dutch adolescent sample. We hypothesize that adolescents who participate in the program Moving Stories will have better mental health literacy and less stigma regarding depression compared to adolescents in the nonintervention control group at posttest and at 3- and 6-months follow-up. We also expect a positive change in actual help-seeking and first aid behavior at 3- and 6-months follow-up. Methods: Moving Stories has been developed by a professional game design company in collaboration with researchers and relevant stakeholders. The effectiveness of Moving Stories will be tested through a randomized controlled trial with two conditions: Moving Stories versus control. Participants will fill in questionnaires at pretest, posttest, and 3- and 6-months follow-up. Our power analysis showed a required sample size of 180 adolescents. Results: Four high schools have agreed to participate with a total of 10 classes. A total of 185 adolescents filled in the pretest questionnaire. The last of the follow-up data was collected in December 2018. Conclusions: If Moving Stories proves to be effective, it could be implemented as a school-based program to target mental health literacy and stigma regarding depression; this could, in turn, improve early help-seeking in adolescents suffering from depression. Trial Registration: Nederlands Trial Register NTR7033; https://www.trialregister.nl/trial/6855 International Registered Report Identifier (IRRID): DERR1-10.2196/11255

  • The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) Registry: Protocol

    Abstract:

    Background: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis. Objective: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. Methods: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints. Conclusions: These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future.

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  • 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

  • Fully-integrated, real-time detection, diagnosis and control of community diarrhoeal disease clusters and outbreaks - the Integrate Project

    Date Submitted: Mar 7, 2019

    Open Peer Review Period: Mar 11, 2019 - Mar 25, 2019

    Background: Diarrhoeal disease, which affects 1 in 4 people in the UK annually, is the most common cause of outbreaks in community and healthcare settings. Traditional surveillance tends to detect poi...

    Background: Diarrhoeal disease, which affects 1 in 4 people in the UK annually, is the most common cause of outbreaks in community and healthcare settings. Traditional surveillance tends to detect point-source outbreaks of diarrhoea and vomiting; it is less effective at identifying low-level and intermittent food supply contamination. Further, it can take up to nine weeks for infections to be confirmed, reducing ‘slow-burn’ outbreak recognition, potentially impacting hundreds or thousands of people over wide geographical areas. There is a need to address fundamental problems in traditional diarrhoeal disease surveillance due to: under-reporting and subsequent unconfirmed infection by patients and general practitioners (GPs); varying submission practices and selective testing of samples in laboratories; limitations in traditional microbiological diagnostics meaning that the timeliness of sample testing and aetiology of most cases remains unknown; and poorly integrated human and animal surveillance systems meaning that identification of zoonoses is delayed or missed. Objectives: These are to: detect anomalous patterns in gastrointestinal disease incidence in the (human) community; target sampling; test traditional diagnostics against rapid modern sensitive molecular and genomic microbiology methods, identifying and characterising responsible pathogens rapidly and more completely; determine the cost-effectiveness of rapid modern sensitive molecular and genomic microbiology methods. Methods: Syndromic surveillance will be used to aid identification of anomalous patterns in microbiological events based upon temporal associations, demographic similarities amongst patients/animals, and changes in trends in acute gastroenteritis cases, using a pointprocess statistical model. Stool samples will be obtained from patients consulting GPs, to improve upon timeliness of cluster-detection and characterise the pathogens responsible, allowing health protection professionals to investigate and control outbreaks quickly, limiting their size and impact. The cost-effectiveness of the proposed system will be examined using formal cost-utility analysis to inform decisions on national implementation. Conclusions: The overall aim is to create a new, 'One Health' paradigm for detecting and investigating diarrhoea and vomiting in the community in near-real-time, shifting from passive human surveillance and management of laboratory-confirmed infection towards an integrated, interdisciplinary enhanced surveillance system including management of people with symptoms.

  • Protocol for a Japanese nationwide repeated cross-sectional study to assess tobacco and nicotine product use behaviour after market introduction of Tobacco Heating Products (THPs)

    Date Submitted: Mar 8, 2019

    Open Peer Review Period: Mar 11, 2019 - Mar 25, 2019

    Background - In recent years there has been a proliferation of alternative tobacco and nicotine products that reduce consumers’ exposure to harmful substances and therefore have the potential to red...

    Background - In recent years there has been a proliferation of alternative tobacco and nicotine products that reduce consumers’ exposure to harmful substances and therefore have the potential to reduce risk to health. Post-market surveillance enables the evaluation of newly introduced tobacco and nicotine products (aka Potentially Reduced Risk Products (PRRPs)) at a population level. This study aims to investigate tobacco and nicotine consumer demographics and discover how people are using these products, and characterise behavioral trends as transitions between tobacco heated products (THPs) and other nicotine products. These behavioural aspects, in conjunction with the intrinsic risk of the product, are essential for assessing the potential health effects and establishing a population risk assessment. Design and Methods - This epidemiological cross-sectional study will collect data using a self-administered study instrument from the general Japanese population aged 20 years and older. The targeted sampling size is up to 5,000 participants per study wave. The study addresses the following objectives: estimation of tobacco and nicotine use prevalence; characterisation of product usage by product type; changes in use behaviour in general, with particular emphasis on the introduction of THPs in the time period of one year; risk perceptions of different tobacco products and no tobacco usage; and participant perceived health status and Quality of Life. Discussion - The description of tobacco and nicotine product use behaviour, the estimation of prevalence data, the measuring of product-specific risk perception and the change of tobacco use behaviour within one year will allow for a comprehensive assessment of the effect of introducing THPs into a market. These data could also be used to inform a System Dynamics Population Model in order to estimate the public health impact of introducing a THP into the Japanese market.

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