JMIR Publications

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  RCTs - Protocols/Proposals (funded,...

  Nov 30, 2020

  Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI)...

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  Authors List:

  • Taiwo O Adebowale  
  • Barry J Taylor  
  • Andrew R Gray  
  • Barbara C Galland  
  • Anne-Louise M Heath  
  • Sarah Fortune  
  • Kim A Meredith-Jones  
  • Trudy Sullivan  
  • Deborah McIntosh  
  • Bradley Brosnan  
  • Rachael W Taylor  

  Abstract:

  Background: The Prevention of Overweight in Infancy (POI) randomized controlled trial assessed the effect of a more conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age. Objective: The primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep. Methods: We will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires). Results: This follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022. Conclusions: Long-term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach. Trial Registration: ClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf

  • JMIR Res Protoc 2020;9(11):e24968

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  RCTs - Pilots/Feasibility Studies...

  Nov 30, 2020

  Sedentariness and Back Health in Western Cape Primary School Students: Protocol for a Pragmatic Stepped-Wedge Feasibility Randomized Controlled Trial

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  Authors List:

  • Dominic Fisher  
  • Quinette Louw  
  • Lehana Thabane  

  Abstract:

  Background: Despite growing evidence of deleterious health outcomes associated with sedentary behavior, prolonged static sitting in classrooms remains ubiquitous in primary schools. Sedentary behavior is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behavior and its negative health effects may be required in a resource-constrained environment such as South Africa. Objective: The primary objective of this study is to assess the feasibility of conducting a full trial to evaluate the effects of a multifaceted intervention comprising novel multifunctional classroom furniture and a video-based curriculum versus usual care on sedentary behavior among students aged 10-11 years in primary schools. The secondary objective is to assess the preliminary effects of the intervention on sedentary behavior and postural dynamism. Methods: Eighty grade 5 or 6 students, aged 10 and 11 years, in mixed-gender schools within the Western Cape metropolitan urban area in Cape Town, South Africa are eligible to participate in this pilot cluster stepped-wedge trial design with classroom as the unit of randomization. Data will be collected at the schools. The intervention will comprise multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behavior. Usual practice is the absence of the intervention. The primary outcomes assessed will be (1) adherence to the intervention and (2) project pragmatics. The secondary outcomes will be (1) sedentariness measured using activPAL3 microsensors and (2) postural dynamism measured using Noraxon Myomotion inertial measurement units. We randomized the school to the first or second start of the intervention. This is an open-label trial and therefore blinding will not be possible for any group. Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of the effects of the intervention on sedentariness and postural dynamism using the mean difference and 95% CI. Results: At the time of submission, two classrooms have been recruited into the study. Baseline physical activity and postural dynamism data have been collected from 10 participants from each class. Conclusions: The results of this feasibility stepped-wedge cluster randomized controlled trial will be useful in informing the design of the main trial to assess whether this multifaceted intervention of multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effect on sedentary behavior in low-resource-setting primary schools. Trial Registration: Pan African Trials Registry PACTR201811799476016; https://tinyurl.com/y4upoys8

  • JMIR Res Protoc 2020;9(11):e18522

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  RCTs - Protocols/Proposals (funded,...

  Nov 30, 2020

  The Precision Health and Everyday Democracy (PHED) Project: Protocol for a Transdisciplinary Collaboration on Health Equity and the Role of Health in Society

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  Authors List:

  • Michael Strange  
  • Carol Nilsson  
  • Slobodan Zdravkovic  
  • Elisabeth Mangrio  

  Abstract:

  Background: The project “Precision Health and Everyday Democracy” (PHED) is a transdisciplinary partnership that combines a diverse range of perspectives necessary for understanding the increasingly complex societal role played by modern health care and medical research. The term “precision health” is being increasingly used to express the need for greater awareness of environmental and genomic characteristics that may lead to divergent health outcomes between different groups within a population. Enhancing awareness of diversity has parallels with calls for “health democracy” and greater patient-public participation within health care and medical research. Approaching health care in this way goes beyond a narrow focus on the societal determinants of health, since it requires considering health as a deliberative space, which occurs often at the banal or everyday level. As an initial empirical focus, PHED is directed toward the health needs of marginalized migrants (including refugees and asylum seekers, as well as migrants with temporary residency, often involving a legally or economically precarious situation) as vulnerable groups that are often overlooked by health care. Developing new transdisciplinary knowledge on these groups provides the potential to enhance their wellbeing and benefit the wider society through challenging the exclusions of these groups that create pockets of extreme ill-health, which, as we see with COVID-19, should be better understood as “acts of self-harm” for the wider negative impact on humanity. Objective: We aim to establish and identify precision health strategies, as well as promote equal access to quality health care, drawing upon knowledge gained from studying the health care of marginalized migrants. Methods: The project is based in Sweden at Malmö and Lund Universities. At the outset, the network activities do not require ethical approval where they will not involve data collection, since the purpose of PHED is to strengthen international research contacts, establish new research within precision strategies, and construct educational research activities for junior colleagues within academia. However, whenever new research is funded and started, ethical approval for that specific data collection will be sought. Results: The PHED project has been funded from January 1, 2019. Results of the transdisciplinary collaboration will be disseminated via a series of international conferences, workshops, and web-based materials. To ensure the network project advances toward applied research, a major goal of dissemination is to produce tools for applied research, including information to enhance health accessibility for vulnerable communities, such as marginalized migrant populations in Sweden. Conclusions: There is a need to identify tools to enable the prevention and treatment of a wide spectrum of health-related outcomes and their link to social as well as environmental issues. There is also a need to identify and investigate barriers to precision health based on democratic principles.

  • JMIR Res Protoc 2020;9(11):e17324

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  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,...

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  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

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  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...

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  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

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  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...

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  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

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  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

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  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

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  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...

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  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

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  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)

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  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

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  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...

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  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

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  Non-Randomized Study Protocols and...

  Nov 23, 2020

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

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  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

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  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

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  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

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