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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:

  • Vintage aviators playing in equilibrium on the void (in relation to the article: metaphorical image of the equilibrium between the choice of demoralization or meaning in life in the face of an absurd suffering). Source: Wikicommons, modified by authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    The Role of Demoralization and Meaning in Life (DEMIL) in Influencing Suicidal Ideation Among Patients Affected by Chronic Pain: Protocol of a Single-Center,...


    Background: Chronic pain is a significant risk factor for suicidal ideation (SI) and suicidal behavior (SB), including a 20%-40% prevalence rate of SI, a prevalence between 5% and 14% of suicide attempts, and a doubled risk of death by suicide in patients with chronic pain compared to controls. In most studies, associations between chronic pain and suicidality are robust, even after adjusting for the effect of sociodemographics and psychiatric comorbidity, and particularly for depressive conditions. A number of specific conditions that can modulate suicidality risk in patients with chronic pain have been investigated, but there is a need for their more specific characterization. Numerous recent studies have shown that demoralization and meaning in life (MiL) constructs affect suicidality as risk and protective factors, respectively. These constructs have been mainly investigated in patients with somatic illness and in community-dwelling individuals who may present with SI or SB independently of a psychiatric diagnosis of depression. However, a paucity of studies investigated them in suicidal patients affected by chronic pain. Objective: The primary objective of this project is to investigate the relationship between demoralization and MiL on SI risk in patients with chronic pain. The secondary objectives are (1) to test whether demoralization can occur independently of depression in patients with chronic pain and SI, (2) to examine whether the expected association between demoralization and SI may be explained by a sole dimension of demoralization: hopelessness, (3) to examine whether the presence of MiL, but not the search for MiL, is associated with less SI, and (4) to explore whether previously described MiL profiles (ie, high presence-high search, high presence-low search, moderate presence-moderate search, low presence-low search, and low presence-high search) emerge in our cohort. Methods: This project is a single-center, observational, case-control study—the Demoralization and Meaning in Life (DEMiL) study—conducted by the Division of Clinical Pharmacology and Toxicology, the Multidisciplinary Pain Centre, and the Service of Liaison Psychiatry and Crisis Intervention at the Geneva University Hospitals. Self- and hetero-administered questionnaires were conducted among patients and controls, matched by age and gender. The Ethics Committee of the Canton of Geneva approved the scientific utilization of collected data (project No. 2017-02138; decision dated January 25, 2018). Data have been analyzed with SPSS, version 23.0, software (IBM Corp). Results: From March 1, 2018, to November 30, 2019, 70 patients and 70 controls were enrolled. Statistical analyses are still in progress and are expected to be finalized in November 2020. To date, we did not observe any unfavorable event for which a causal relationship with the collection of health-related personal data could be ruled out. Results of this study are expected to form the basis for possible prevention and psychotherapeutic interventions oriented toward demoralization and MiL constructs for suicidal patients with chronic pain. Conclusions: The interest in exploring demoralization and MiL in chronic pain patients with SI arises from the common clinical observation that experiencing chronic pain often requires a revision of one’s life goals and expectations. Hence, the impact of chronic pain is not limited to patients’ biopsychosocial functioning, but it affects the existential domain as well. The major clinical implications in suicidal patients with chronic pain consist in trying to (1) delineate a more precise and individualized suicide risk profile, (2) improve detection and prevention strategies by investigating SI also in individuals who do not present with a clinically diagnosed depression, and (3) enhance the panel of interventions by broadening supportive or psychotherapeutic actions, taking into consideration the existential condition of a person who suffers and strives to deal with his or her suffering.

  • Source: Pixabay; Copyright: qimono; URL:; License: Creative Commons Attribution (CC-BY).

    The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial...


    Background: A core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. Objective: This is a protocol for studies to assess if there are order effects among the questions included in the COS. Methods: The 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire. Results: Data collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire. Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023. Conclusions: Homogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community. We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis. Trial Registration: ISRCTN Registry ISRCTN17954645;

  • Source: Adobe Stock; Copyright: Image Source; URL:; License: Licensed by JMIR.

    Development and Validation of a Scale to Measure Intimate Partner Violence Among Transgender and Gender Diverse Populations: Protocol for a Linear...


    Background: Intimate partner violence (IPV) is approximately twice as prevalent among transgender and gender diverse individuals (those whose current gender identity does not match their sex assigned at birth) than among cisgender individuals (those whose gender aligns with their sex assigned at birth). However, most existing scales measuring IPV are not validated among transgender and gender diverse populations and do not consider the unique forms of IPV experienced by transgender and gender diverse individuals. Objective: This paper describes the protocol for Project Empower, a study that seeks to develop and validate a new scale to measure IPV as experienced by transgender and gender diverse adults. A new scale is necessary to improve the accuracy of IPV measurement among transgender and gender diverse populations and may inform the current tools used to screen and link to services for transgender and gender diverse adults who experience or perpetrate IPV. Methods: The proposed new scale will be developed by a linear three-phase process. In Phase I, we will recruit a maximum of 110 transgender and gender diverse participants to participate in in-depth interviews and focus groups. Phase I will collect qualitative data on the experiences of IPV among transgender and gender individuals. After generating scale items from the qualitative data in Phase I, Phase II will conduct up to 10 cognitive interviews to examine understanding of scale items and refine wording. Phase III will then conduct a survey with an online recruited sample of 700 transgender and gender diverse individuals to validate the scale using factor analysis and examine the prevalence, antecedents, and linked health outcomes of IPV. This study will generate the first comprehensive IPV scale including trans-specific IPV tactics that has undergone robust mixed-methods validation for use in transgender and gender diverse populations, regardless of sex assigned at birth. Results: Project Empower launched in August 2019, with Phases I and II expected to be complete by late 2020. Phase III (survey of 700 transgender individuals) is expected to be launched in January 2021. Conclusions: A scale that more accurately captures the forms of IPV experienced by transgender and gender diverse people not only has the potential to lead to more accurate measurements of prevalence but also can identify unique forms of violence that may form the basis of IPV prevention interventions. Additionally, identifying the forms of IPV experienced by transgender and gender diverse people has the potential to lead to the refinement of clinical screening tools used to identify and refer those who experience and perpetrate violence in clinical settings.

  • Source: Shutterstock; Copyright: Ahmet Misirligul; URL:; License: Licensed by the authors.

    A Mental Health Surveillance System for the General Population During the COVID-19 Pandemic: Protocol for a Multiwave Cross-sectional Survey Study


    Background: The COVID-19 outbreak can potentially be categorized as a traumatic event. Public health surveillance is one of the cornerstones of public health practice, and it empowers decision makers to lead and manage public health crises and programs more effectively by providing timely and useful evidence. Objective: This paper presents the protocol for a study that aims to identify, track, and monitor trends in the population in Saudi Arabia at risk of major depressive disorders and anxiety during the COVID-19 pandemic. Methods: This study utilizes continuous, cross-sectional, national-level mental health screening via computer-assisted phone interviews, conducted in four waves on a monthly basis (between May and August 2020). Arabic-speaking adults, aged ≥18 years, and living in Saudi Arabia were recruited via a random phone list. This surveillance system used the proportional quota sampling technique to achieve an equal distribution of participants, stratified by age and gender, and region, within and across the 13 administrative regions of Saudi Arabia. A sample size of 4056 participants per wave was calculated to achieve enough power to detect changes in mental health status. The questionnaire includes the Arabic version of the Patient Health Questionnaire-9 (PHQ-9) to measure depressive symptoms and the General Anxiety Disorder-7 (GAD-7) to measure anxiety. In addition, it will collect data on sociodemographic variables and potential risk factors. Results: Study recruitment began in May 2020. The data analysis was completed in October 2020, and the final report is expected to be published by the end of December 2020. Conclusions: Monitoring the population’s mental health status during the COVID-19 pandemic will inform decision makers of any potential deterioration in mental health on a national level and among subgroups, including across regions, age groups, and gender groups. It will allow decision makers to recognize issues and intervene sooner. It will also provide valuable scientific data to help understand the effects of epidemics and pandemics on mental health. As far as we know, this is the only study that attempts to monitor the mental health status of the general population on a monthly basis. Trial Registration:

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

    Building a Digital Bridge to Support Patient-Centered Care Transitions From Hospital to Home for Older Adults With Complex Care Needs: Protocol for a...


    Background: Older adults with multimorbidity and complex care needs (CCN) are among those most likely to experience frequent care transitions between settings, particularly from hospital to home. Transition periods mark vulnerable moments in care for individuals with CCN. Poor communication and incomplete information transfer between clinicians and organizations involved in the transition from hospital to home can impede access to needed support and resources. Establishing digitally supported communication that enables person-centered care and supported self-management may offer significant advantages as we support older adults with CCN transitioning from hospital to home. Objective: This protocol outlines the plan for the development, implementation, and evaluation of a Digital Bridge co-designed to support person-centered health care transitions for older adults with CCN. The Digital Bridge builds on the foundation of two validated technologies: Care Connector, designed to improve interprofessional communication in hospital, and the electronic Patient-Reported Outcomes (ePRO) tool, designed to support goal-oriented care planning and self-management in primary care settings. This project poses three overarching research questions that focus on adapting the technology to local contexts, evaluating the impact of the Digital Bridge in relation to the quadruple aim, and exploring the potential to scale and spread the technology. Methods: The study includes two phases: workflow co-design (phase 1), followed by implementation and evaluation (phase 2). Phase 1 will include iterative co-design working groups with patients, caregivers, hospital providers, and primary care providers to develop a transition workflow that will leverage the use of Care Connector and ePRO to support communication through the transition process. Phase 2 will include implementation and evaluation of the Digital Bridge within two hospital systems in Ontario in acute and rehab settings (600 patients: 300 baseline and 300 implementation). The primary outcome measure for this study is the Care Transitions Measure–3 to assess transition quality. An embedded ethnography will be included to capture context and process data to inform the implementation assessment and development of a scale and spread strategy. An Integrated Knowledge Translation approach is taken to inform the study. An advisory group will be established to provide insight and feedback regarding the project design and implementation, leading the development of the project knowledge translation strategy and associated outputs. Results: This project is underway and expected to be complete by Spring 2024. Conclusions: Given the real-world implementation of Digital Bridge, practice changes in the research sites and variable adherence to the implementation protocols are likely. Capturing and understanding these considerations through a mixed-methods approach will help identify the range of factors that may influence study results. Should a favorable evaluation suggest wide adoption of the proposed intervention, this project could lead to positive impact at patient, clinician, organizational, and health system levels. Trial Registration: NCT04287192;

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

    Assessing the Effect of Training on the Cognition and Brain of Older Adults: Protocol for a Three-Arm Randomized Double-Blind Controlled Trial (ACTOP)


    Background: To prevent age-related cognitive impairment, many intervention programs offer exercises targeting different central cognitive processes. However, the effects of different process-based training programs are rarely compared within equivalent experimental designs. Objective: Using a randomized double-blind controlled trial, this project aims to examine and compare the impact of 2 process-based interventions, inhibition and updating, on the cognition and brain of older adults. Methods: A total of 90 healthy older adults were randomly assigned to 1 of 3 training conditions: (1) inhibition (Stroop-like exercises), (2) updating (N-back-type exercises), and (3) control active (quiz game exercise). Training was provided in 12 half-hour sessions over 4 weeks. First, the performance gain observed will be measured on the trained tasks. We will then determine the extent of transfer of gain on (1) untrained tasks that rely on the same cognitive process, (2) complex working memory (WM) measurements hypothesized to involve 1 of the 2 trained processes, and (3) virtual reality tasks that were designed to mimic real-life situations that require WM. We will assess whether training increases cortical volume given that the volume of the cortex is determined by cortical area and thickness in regions known to be involved in WM or changes task-related brain activation patterns measured with functional magnetic resonance imaging. Dose effects will be examined by measuring outcomes at different time points during training. We will also determine whether individual characteristics moderate the effect of training on cognitive and cerebral outcomes. Finally, we will evaluate whether training reduces the age-related deficit on transfer and brain outcomes, by comparing study participants to a group of 30 younger adults. Results: The project was funded in January 2017; enrollment began in October 2017 and data collection was completed in April 2019. Data analysis has begun in June 2020 and the first results should be published by the end of 2020 or early 2021. Conclusions: The results of this study will help understand the relative efficacy of 2 attentional control interventions on the cognition and the brain of older adults, as well as the moderating role of individual characteristics on training efficiency and transfer. Trial Registration: NCT03532113;

  • Source: Freepik; Copyright: dashu83; URL:; License: Licensed by JMIR.

    Family Members’ Perspectives on Family and Social Support Available to Suicidal Patients, and Health Systems’ Interactions and Responses to Suicide Cases...


    Background: Suicide is a major cause of preventable death globally and a leading cause of death by injury in Canada. To support people who experience suicidal thoughts and behaviors and to ultimately prevent people from dying by suicide, it is important to understand individual and familial experiences with the health care system. Objective: We present the protocol for a study, the objective of which is to explore how people who died by suicide, and their family members, interacted with the health care system. Methods: This is a quantitative research study. Data will be collected through a self-administered paper-based or online survey of the family member of patients who died by suicide. The sample size was calculated to be 385 (margin of error ±3%). Results: Data collection will start in October 2020 and results will be available by March 2021. We expect the results to shed light on the experiences of individuals who died by suicide and their family members with the health care system. The study has received ethical clearance from the Health Ethics Research Board of the University of Alberta (Pro00096342). Conclusions: Our study may inform practice, policy, and future research. The findings may shape how members of the health care system respond to people who are at risk of suicide and their families.

  • Source: Pexels; Copyright: Gustavo Fring; URL:; License: Licensed by JMIR.

    Risk Perception of Health Professionals in Intrapartum Care Decisions: Protocol for a Mixed Methods Study


    Background: Risk perception plays an important role in decision-making processes. Differences in obstetric intervention rates suggest that, in addition to medical indications, the risk perception of obstetric health professionals might have a major influence on their decision-making process during childbirth. Although studies have investigated whether risk perception affects the role of midwifery or influences decision making during childbirth, little is known about what obstetric health professionals actually perceive as risk or risky situations and whether different risk perceptions lead to more interventions during intrapartum care. Objective: The objective of this study is to understand the association of risk perception and the decision-making processes of obstetric health professionals (midwives and obstetricians) in Germany during intrapartum care. The study has 3 specific aims: (1) gain insight into what obstetric health professionals perceive as risk in the German clinical setting, (2) assess the extent to which personal and systemic factors have an impact on obstetric health professionals’ risk perception, and (3) investigate whether different perceptions of risk are associated with different decisions being made by obstetric health professionals. Methods: This is an exploratory sequential mixed methods study with 2 phases, a qualitative followed by a quantitative phase. In the first phase, qualitative data are collected and analyzed by conducting focus group discussions and applying qualitative content analysis to address aim 1. In the second phase, for aims 2 and 3 and to help explain the qualitative results, quantitative data are collected and analyzed by conducting an observational study using case vignettes within a survey constructed on the basis of the qualitative results. Results: Enrollment in the first (qualitative) phase began in July 2019, and data collection and analysis have been completed. The second (quantitative) phase is currently planned, and data collection is expected to start in December 2020. First results of the qualitative phase are expected to be submitted for publication in 2020, with completion of the second phase scheduled for 2021. Conclusions: This mixed methods study will examine the perception of risk and its association with the decision-making processes of obstetric health professionals during their care of women in childbirth. The rationale for this approach is that the qualitative data and their analysis explore participants' views in more depth, while the quantitative data will help to provide and explore a general understanding of the research problem. The results are expected to be relevant to health care professionals, policymakers, and educational institutions in order to minimize underuse, overuse, and misuse of interventions during intrapartum care. Trial Registration: German Clinical Trials Register DRKS00017172;

  • Source: flickr; Copyright: NEC Corporation of America; URL:; License: Creative Commons Attribution (CC-BY).

    Use and Evaluation of Computerized Clinical Decision Support Systems for Early Detection of Sepsis in Hospitals: Protocol for a Scoping Review


    Background: Sepsis is a leading cause of death in hospitals, with high associated costs for both patients and health care systems worldwide. Early detection followed by timely intervention is critical for successful sepsis management and, hence, can save lives. Health care institutions are increasingly leveraging clinical data captured in electronic health records for the development of computerized clinical decision support (CCDS) systems aimed at enhancing the early detection of sepsis. However, a comprehensive evidence base regarding sepsis CCDS systems to inform clinical practice, research, and policy is currently lacking. Objective: This scoping review aims to systematically describe studies reporting on the use and evaluation of CCDS systems for early detection of sepsis in hospitals. Methods: The methodology for conducting scoping reviews presented by the Joanna Briggs Institute Reviewer’s Manual and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) will be used and adapted as guides. A comprehensive literature search of 10 electronic databases will be conducted to identify all empirical quantitative and qualitative studies that investigate the use of CCDS systems for early detection of sepsis in hospitals. Detailed inclusion and exclusion criteria have been developed. Two reviewers will independently screen all articles based on these criteria. Any discrepancies will be resolved through discussion and further review by a third researcher if required. Results: Electronic database searches have retrieved 12,139 references after removing 10,051 duplicates. As of the submission date of this protocol, we have completed the title and abstract screening. A total of 372 references will be included for full-text screening. Only 15.9% (59/372) of these studies were focused on children: 11.0% (41/372) for pediatric and 4.8% (18/372) for neonatal patients. The scoping review and the manuscript will be completed by December 2020. Conclusions: Results of this review will guide researchers in determining gaps and shortcomings in the current evidence base for CCDS system use and evaluation in the early detection of sepsis. The findings will be shared with key stakeholders in clinical care, research, policy, and patient advocacy.

  • Source: Pexels; Copyright:; URL:; License: Licensed by JMIR.

    Development of a Personalized Mobile Mental Health Intervention for Workplace Cyberbullying Among Health Practitioners: Protocol for a Mixed Methods Study


    Background: Workplace cyberbullying harms the psychological and social functioning of professionals working in an organization and may decrease the productivity and efficiency of daily life tasks. A recent study on trainee doctors across 8 different United Kingdom National Health Service trusts found health issues and job dissatisfaction in people who have experienced workplace cyberbullying. This disabling effect is even more noticeable in low-socioeconomic communities within low-income countries. In Malaysia, there is a need to create a personalized mobile mental health intervention program for health care professionals. These programs should be directed to prevent and decrease psychosocial issues and enhance coordination among health care professionals to solve health issues in the community. Objective: Our main objective is to study the pre-effects and posteffects of the Personalized Mobile Mental Health Intervention (PMMH-I) for workplace cyberbullying in public and private hospitals in Malaysia. Methods: A hospital-based multimethod multi-analytic evidential approach is proposed, involving social and psychological health informatics. The project has been subdivided into 3 stages, starting with Phase 1, a prevalence study, followed by exploratory studies. Phase 2 consists of a quasi-experimental design, whereas the development of a prototype and their testing will be proposed in Phase 3. Each stage includes the use of quantitative and qualitative methods (mixed-method program), using SPSS (version 26.0; IBM Corp) and Stata (version 16.1; StataCorp) as tools for quantitative research, and NVivo (version 1.0; QSR International) and Atlas.ti (version 9.0.16; ATLAS.ti Scientific Software Development GmbH) for qualitative research. Results: The results of this study will determine the pre- and posteffectiveness of an integrated PMMH-I for health care professionals. The prototype system platform will be developed and implemented in a public and private hospital. Results from Phase 1 will be published in 2021, followed by the implementation of Phase 2 in subsequent years. Conclusions: This study will provide evidence and guidance regarding the implementation of a personalized mobile mental health intervention for health care professionals into routine public and private hospitals to enhance communication and resolve conflicts.

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

    The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial


    Background: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. Objective: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. Methods: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). Results: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. Conclusions: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. Trial Registration: International Standard Randomized Controlled Trial Number 23758980;

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    Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High...


    Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. Objective: The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. Methods: The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. Conclusions: This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Trial Registration: NCT03576313;

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  • Effects of a school-based physical activity intervention for fatness and health-related physical fitness in adolescents with intellectual disability: a study protocol for a randomized controlled trial

    Date Submitted: Nov 19, 2020

    Open Peer Review Period: Nov 19, 2020 - Jan 14, 2021

    Background: Childhood obesity accompanied with lower levels of health-related physical fitness (HRPF) is a major threat to public health both internationally and locally. Children with intellectual di...

    Background: Childhood obesity accompanied with lower levels of health-related physical fitness (HRPF) is a major threat to public health both internationally and locally. Children with intellectual disability (ID), especially adolescents, have a higher risk of being overweight/obese and having poor HRPF levels. More interventions, therefore, are needed to help this population attain their optimal health levels. However, there has been limited research on this population compared with studies designed for their typically developing (TD) peers. Objective: The proposed study aims to fill this knowledge gap by developing and examining the success of a physical activity (PA) intervention for the target population. Methods: The proposed study will be a school-based randomised controlled trial lasting for 12 weeks. The participants (N=48) will be recruited from special schools for students with mild ID and then randomly allocated to either the intervention group (IG) or the waiting-list control group (CG). During the intervention period, the participants in the IG will receive a fun, game-based moderate-to-vigorous physical activity (MVPA) training programme (twice/week, 60-min/session, a total of 24 sessions). The intensity of the activities will increase in a progressive manner. Those in the CG will receive no intervention. To observe and evaluate the sustaining effects of the intervention, follow-up testing will be scheduled for the participants 12 weeks after the intervention concludes. The study outcomes will include primary outcomes (fatness-related outcomes and fitness-related outcomes) and secondary outcomes (blood pressure). All of the measurements will be taken three times. After the follow-up tests, the same PA training programme will be provided to the participants in the CG. Results: This study is ongoing. The participants were recruited from October 2020 to November 2020. Total duration of the study is 13 months. Study results are expected at the end of 2021. Conclusions: The proposed study is expected to reduce fatness and improve HRPF levels in children with ID. If proven effective, the intervention will be made accessible to more special schools and mainstream schools with students with ID. Furthermore, the study can serve as an example for international researchers, policymakers and the public who are seeking to tackle the problem of obesity and poor HRPF among children with ID. Clinical Trial: This trial is prospectively registered at the PRS (Trial ID: NCT04554355; Date of First Posted: September 17, 2020).

  • The impact of enhanced recovery after surgery on total joint arthroplasty: A protocol for systematic review and meta-analysis

    Date Submitted: Nov 15, 2020

    Open Peer Review Period: Nov 15, 2020 - Jan 10, 2021

    Background: The number of total joint arthroplasty being performed is increasing worldwide. To match this increasing demand, there has been focus on hastening patients’ recovery of function. This ef...

    Background: The number of total joint arthroplasty being performed is increasing worldwide. To match this increasing demand, there has been focus on hastening patients’ recovery of function. This effort has culminated in formulation of enhanced recovery for surgery (ERAS) strategies. However, with evolving ERAS programs and new recommendations, a review of current evidence is required to provide clinicians with up-to-date information about its effect on outcomes for total joint arthroplasty. Objective: This study outlines the protocol for a systematic review and meta-analysis that aims to assess the utility of enhanced recovery after surgery programs on patient, health services and economic outcomes for primary, elective total hip and knee arthroplasty. Methods: A systematic search will be conducted in Medline (OVID), EMCARE (OVID), Web of Science, CINAHL, National Health Service Economic Evaluations Database and the Cochrane Library. Analytical, observational and experimental designs will be included in this systematic review. Only studies including patients undergoing primary, total knee and hip arthroplasty comparing ERAS programs with conventional surgery and postoperative care will be included. Data related to patient outcomes, health service outcomes, safety and economic evaluation will be extracted. Results: The search terms have been finalized, and the final primary database search will be completed in November 2020. The results of this systematic review will be disseminated in a peer-reviewed journal. Conclusions: This protocol will guide a systematic review assessing outcomes associated with ERAS surgery in primary, total hip and knee arthroplasty Clinical Trial: Open Science Framework. Doi: 10.17605/OSF.IO/Y4BHS

  • Assessing Mental Health in Emerging Adulthood through a Mental Health Navigator: A Study Protocol

    Date Submitted: Nov 15, 2020

    Open Peer Review Period: Nov 15, 2020 - Jan 10, 2021

    Background: Even the same psychological disorders present themselves differently among individuals, underscoring the need for a personalized model approach to the study of psychopathology. Emerging ad...

    Background: Even the same psychological disorders present themselves differently among individuals, underscoring the need for a personalized model approach to the study of psychopathology. Emerging adulthood is a developmental phase wherein individuals experience unique vulnerability to the development of psychopathology given their exposure to repeated stressors and their disruptions in routine, making them a population worthy of investigation. Objective: This prospective study aims to leverage multi-modal assessments to examine the feasibility of an individualized approach to understanding contextual factors relevant to changes in daily affect, sleep, physiology, and activities in the service of predicting changes in mental health. Methods: Recruited participants will be monitored for a period of time (between 3 and 12 months). Participants will download the Personicle application on their smartphone to track activities (e.g. home events, cycling) and be given wearable sensor devices to wear continuously (monitors sleep, physiology, and physical activity). They will be asked to report daily mood and complete weekly open-ended text responses as well as a battery of questionnaires every 3 months. Results: Our study has been approved by the Institutional Review Board and is currently undergoing data collection. Adjustments were made due to the COVID-19 pandemic to enable remote data collection and assess for COVID-19-related stress. Conclusions: This study will help advance the research of individualized approaches to understanding health and well-being through multi-modal systems and will demonstrate the benefit of using such approaches to study interrelations between stress, social relationships, technology and mental health.

  • Understanding Patterns of Healthy Aging Among Men Who Have Sex with Men: Study Methods Paper

    Date Submitted: Nov 13, 2020

    Open Peer Review Period: Nov 13, 2020 - Jan 8, 2021

    Background: With the greying of sexual and gender minority communities and the growing numbers of people over the age of 50 living with HIV, it is increasingly important to understand the psychosocial...

    Background: With the greying of sexual and gender minority communities and the growing numbers of people over the age of 50 living with HIV, it is increasingly important to understand the psychosocial aspects of aging and aging well. Objective: This paper describes the methods for the Understanding Patterns of Healthy Aging Among Men Who Have Sex With Men. Methods: This observational cohort study is conducted within the Multisite AIDS Cohort Study (MACS) and is designed to explore resiliencies to explain patterns of health and illness among midlife and older MSM. To be eligible a participant had to: (1) be an active participant in the MACS; (2) be at least 40 years old by April 1, 2016; and (3) report any sex with another man since enrollment in the MACS. Results: Eligible participants (N=1,318) completed 6 biannual surveys between April 2016-April 2019. The mean age of the sample was 59.6 years old (range=40-91). The sample was mostly white, educated, gay-identified and included both HIV-positive (49.8%) and HIV-negative (50.2%) men. Conclusions: Integrating resiliencies in surveillance applications of syndemics theory is a critical springboard for the development of effective interventions that support healthy aging among older MSM.

  • SARS-CoV-2 Infection in Healthcare Personnel and Their Household Contacts at a Tertiary Academic Medical Center: Protocol for a Longitudinal Cohort Study

    Date Submitted: Nov 17, 2020

    Open Peer Review Period: Nov 3, 2020 - Dec 29, 2020

    Background: Healthcare personnel are at high risk for exposure to the SARS-CoV-2 virus. While personal protective equipment may mitigate this risk, prospective data collection on its use and other ris...

    Background: Healthcare personnel are at high risk for exposure to the SARS-CoV-2 virus. While personal protective equipment may mitigate this risk, prospective data collection on its use and other risk factors for seroconversion in this population is needed. Objective: The primary objectives of this study are to (1) determine the incidence of and risk factors for SARS-CoV-2 infection among healthcare personnel at a tertiary medical center and (2) actively monitor personal protective equipment use, interactions between study participants via electronic sensors, secondary cases in households, and participant mental health and well-being. Methods: To achieve these objectives, we designed a prospective, observational study of SARS-CoV-2 infection among healthcare personnel and their household contacts at an academic tertiary care medical center. Enrolled healthcare personnel completed frequent surveys on symptoms and work activities and provided serum and nasal samples for SARS-CoV-2 testing every two weeks. Additionally, interactions between participants and their movement within the clinical environment were captured with a smartphone app and Bluetooth sensors. Finally, a subset of participants' households was randomly selected every two weeks for further investigation, and enrolled households provided serum and nasal samples via at-home collection kits. Results: As of September 30, 2020, 164 healthcare personnel and 33 household participants have been enrolled. Recruitment and follow-up are ongoing and expected to continue until March 2021. Conclusions: Much remains to be learned regarding risk of SARS-CoV-2 infection among healthcare personnel and their household contacts. Through use of a multi-faceted study design enrolling a well-characterized cohort, we will collect critical information regarding SARS-CoV-2 transmission in the healthcare setting and its linkage to the community.

  • Phototherapy using a Light Emitting Fabrics device (Bubolight® device) in the treatment of new-born jaundice: Protocol for an interventional efficacy and safety study.

    Date Submitted: Oct 13, 2020

    Open Peer Review Period: Oct 6, 2020 - Dec 1, 2020

    Background: Neonatal jaundice is a very common condition occurring in 60–80% of all healthy term and late preterm neonates. In the newborn and especially in premature infants, the liver, which is st...

    Background: Neonatal jaundice is a very common condition occurring in 60–80% of all healthy term and late preterm neonates. In the newborn and especially in premature infants, the liver, which is still immature, is unable to eliminate the full amount of bilirubin. In the majority of cases, neonatal jaundice resolves spontaneously and causes no harm; however, in some babies, significant hyperbilirubinemia can develop. Bilirubin then accumulates in the blood and when too high, it can then lead to a serious neurological disease: kernicterus jaundice. Phototherapy is an effective therapy for jaundice and ideal phototherapy device should have a broad light emission surface, in order to cover the maximum of the body surface in the horizontal plane, it should generate no or little heat and provide a wavelength and light intensity optimal (420-490nm and ≥ 30µw / cm²/nm) Objective: The aim of the study is to investigate the feasibility, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy, BUBOLight®, to which luminous textile have been incorporated in a sleeping bag. BUBOLight® emits homogeneous and stable light with a wavelength of 445 nm, for an irradiance of 3.5 mW/cm². It is easy to use and allows to carry out the phototherapy in the arms of the parents, thus preserving the parent–infant bonding. The primary end point of the study is to evaluate the safety of the BUBOLight® phototherapy device as an alternative to conventional hospital phototherapy under the usual conditions for the management of newborns jaundice. Secondary end points are the incidence of side effects (diarrhea, dehydration, skin lesions, temperature) related to phototherapy, evolution of blood bilirubin rate, perceptions of the parents and health team with the use of the device and the impact of the device on parent-child interactions and child comfort. Methods: The trial is an interventional, exploratory, simple group, non-randomized and single center (Lille Hospital) study. Ten to fifteen newborns and their parents will be included to obtain evaluable data from 10 parent-newborn pairs. Newborns more than 2500g of birth weight and born at greater than or equal to 37 weeks of gestation that required phototherapy according to the guidelines of the National Institute For Health and Clinical Excellence will receive one session of 4 hours of illumination. Bilirubin seric and transcutaneous levels were taken at the start and 2 hours after the end of phototherapy. Axillary temperature, heart rate and oxygen saturation will be measured at the beginning and during phototherapy. Number of subjects is therefore not calculated on the basis of statistical assumptions. The objective is to obtain a minimum proportion of 90% of the newborns included (i.e. 9 out of 10) who have been able to undergo 4-hours phototherapy treatment without unacceptable and unexpected toxicities. We will calculate the mean, median, quartiles, minimum and maximum of the quantitative parameters and the frequency of the qualitative parameters. The rate of patients with no unacceptable and unexpected toxicities (primary endpoint) will be calculated. Results: First patient is expected to be included at the end of 2020 and clinical investigations are planned until June 2021. The final results of this study are expected to be available at the end of 2021 Conclusions: This trial aims to evaluate the safety and feasibility of a new phototherapy device based on light emitting fabrics for the treatment of newborn jaundice. The objective of this new system if, it is effective, to improve the humanization of newborn care avoiding the mother-and-child separation. Clinical Trial: NCT04365998;