JMIR Publications

Recent Articles:

• 

  RCTs - Protocols/Proposals (funded,...

  Nov 26, 2020

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

  View Authors View Abstract

  Authors List:

  • Alessandra Costanza  
  • Vasileios Chytas  
  • Viridiana Mazzola  
  • Valérie Piguet  
  • Jules Desmeules  
  • Guido Bondolfi  
  • Christine Cedraschi  

  Abstract:

  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.

  • JMIR Res Protoc 2020;9(11):e24882

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Nov 26, 2020

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

  View Authors View Abstract

  Authors List:

  • Marcus Bendtsen  
  • Claire Garnett  
  • Paul Toner  
  • Gillian W Shorter  

  Abstract:

  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; http://www.isrctn.com/ISRCTN17954645

  • JMIR Res Protoc 2020;9(11):e24175

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Pilots/Feasibility Studies...

  Nov 26, 2020

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

  View Authors View Abstract

  Authors List:

  • Rob Stephenson  
  • Kieran Todd  
  • Kristi E Gamarel  
  • Sarah Peitzmeier  

  Abstract:

  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.

  • JMIR Res Protoc 2020;9(11):e23819

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Studies (funded,...

  Nov 26, 2020

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

  View Authors View Abstract

  Authors List:

  • Nasser F BinDhim  
  • Nora A Althumiri  
  • Mada H Basyouni  
  • Asem A Alageel  
  • Suliman Alghnam  
  • Ada M Al-Qunaibet  
  • Rasha A Almubark  
  • Shahla Aldhukair  
  • Yasser Ad-Dab'bagh  

  Abstract:

  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:

  • JMIR Res Protoc 2020;9(11):e23748

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  CIHR funded proposals with...

  Nov 25, 2020

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

  View Authors View Abstract

  Authors List:

  • Carolyn Steele Gray  
  • Terence Tang  
  • Alana Armas  
  • Mira Backo-Shannon  
  • Sarah Harvey  
  • Kerry Kuluski  
  • Mayura Loganathan  
  • Jason X Nie  
  • John Petrie  
  • Tim Ramsay  
  • Robert Reid  
  • Kednapa Thavorn  
  • Ross Upshur  
  • Walter P Wodchis  
  • Michelle Nelson  

  Abstract:

  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: ClinicalTrials.gov NCT04287192; https://clinicaltrials.gov/ct2/show/NCT04287192

  • JMIR Res Protoc 2020;9(11):e20220

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Nov 24, 2020

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

  View Authors View Abstract

  Authors List:

  • Arnaud Boujut  
  • Samira Mellah  
  • Maxime Lussier  
  • Samantha Maltezos  
  • Lynn Valeyry Verty  
  • Louis Bherer  
  • Sylvie Belleville  

  Abstract:

  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: ClinicalTrials.gov NCT03532113; https://clinicaltrials.gov/ct2/show/NCT03532113

  • JMIR Res Protoc 2020;9(11):e20430

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Nov 24, 2020

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

  View Authors View Abstract

  Authors List:

  • Rabab M Abou El-Magd  
  • Liana Urichuk  
  • Shireen Surood  
  • Daniel Li  
  • Andrew Greenshaw  
  • Mara Grunau  
  • Laureen MacNeil  
  • Ione Challborn  
  • David Grauwiler  
  • Robert Olson  
  • Vincent Israel Opoku Agyapong  

  Abstract:

  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.

  • JMIR Res Protoc 2020;9(11):e19112

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Nov 23, 2020

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

  View Authors View Abstract

  Authors List:

  • Nina H Peterwerth  
  • Margareta Halek  
  • Sabrina Tulka  
  • Rainhild Schäfers  

  Abstract:

  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; https://tinyurl.com/y2zoowkx

  • JMIR Res Protoc 2020;9(11):e21443

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Scoping Review Protocols

  Nov 20, 2020

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

  View Authors View Abstract

  Authors List:

  • Ling Li  
  • Khalia Ackermann  
  • Jannah Baker  
  • Johanna Westbrook  

  Abstract:

  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.

  • JMIR Res Protoc 2020;9(11):e24899

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Nov 20, 2020

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

  View Authors View Abstract

  Authors List:

  • Yun Jin Kim  
  • Linchao Qian  
  • Muhammad Shahzad Aslam  

  Abstract:

  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.

  • JMIR Res Protoc 2020;9(11):e23112

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Nov 20, 2020

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

  View Authors View Abstract

  Authors List:

  • Kirsten Ailsa Smith  
  • Katherine Bradbury  
  • Rosie Essery  
  • Sebastien Pollet  
  • Fiona Mowbray  
  • Joanna Slodkowska-Barabasz  
  • James Denison-Day  
  • Victoria Hayter  
  • Jo Kelly  
  • Jane Somerville  
  • Jin Zhang  
  • Elisabeth Grey  
  • Max Western  
  • Anne E Ferrey  
  • Adele Krusche  
  • Beth Stuart  
  • Nanette Mutrie  
  • Sian Robinson  
  • Guiqing Lily Yao  
  • Gareth Griffiths  
  • Louise Robinson  
  • Martin Rossor  
  • John Gallacher  
  • Simon Griffin  
  • Tony Kendrick  
  • Shanaya Rathod  
  • Bernard Gudgin  
  • Rosemary Phillips  
  • Tom Stokes  
  • John Niven  
  • Paul Little  
  • Lucy Yardley  

  Abstract:

  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; http://www.isrctn.com/ISRCTN23758980

  • JMIR Res Protoc 2020;9(11):e18929

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (non-eHealth)

  Nov 19, 2020

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

  View Authors View Abstract

  Authors List:

  • Edgard Diniba Dabira  
  • Harouna M Soumare  
  • Steven W Lindsay  
  • Bakary Conteh  
  • Fatima Ceesay  
  • John Bradley  
  • Christian Kositz  
  • Henk Broekhuizen  
  • Balla Kandeh  
  • Alexandra E Fehr  
  • Claudia Nieto-Sanchez  
  • Joan Muela Ribera  
  • Koen Peeters Grietens  
  • Menno Roderick Smit  
  • Chris Drakeley  
  • Teun Bousema  
  • Jane Achan  
  • Umberto D’Alessandro  

  Abstract:

  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: ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313

  • JMIR Res Protoc 2020;9(11):e20904

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.