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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:

  • Source: iStock by Getty Images; Copyright: Wavebreakmedia; URL: https://www.istockphoto.com/ca/photo/women-in-pink-outfits-joining-in-a-circle-for-breast-cancer-awareness-gm663160528-120740799; License: Licensed by the authors.

    An Electronic Health Intervention for Latina Women Undergoing Breast Cancer Treatment (My Guide for Breast Cancer Treatment): Protocol for a Randomized...

    Abstract:

    Background: Among Latinas and Hispanics (henceforth referred to as Latinas), breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths. However, few interventions have been developed to meet the needs of Latina women undergoing active treatment for breast cancer. Objective: This paper aims to describe the procedures and methods of My Guide for Breast Cancer Treatment and the plans for conducting a multisite randomized controlled trial to investigate the feasibility and preliminary efficacy of this smartphone-based app for Latina women in active treatment for breast cancer. Methods: Study participants will be randomized to the My Guide for Breast Cancer Treatment intervention or the enhanced usual care control condition for 12 weeks. Participants will have access to innovative features such as gamification via virtual awards to reinforce usage and an adaptive section that presents targeted material based on their self-reported concerns and needs. Using a stepped-care approach, intervention participants will also receive telecoaching to enhance their adherence to the app. Study outcomes and intervention targets will be measured at study enrollment (before randomization), 6 and 12 weeks after initial app use. General and disease-specific health-related quality of life (HRQoL) and symptom burden are the study’s primary outcomes, whereas anxiety, depression, fear of cancer recurrence, physical activity, and dietary intake are secondary outcomes. Results: Recruitment began in August 2019 and is expected to be completed by August 2020. We expect to submit study results for publication by fall 2020. Conclusions: My Guide for Breast Cancer Treatment has the potential to improve HRQoL and reduce symptom burden, and increase access to supportive care resources among Latina breast cancer patients.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/12/e15634/; License: Creative Commons Attribution (CC-BY).

    Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

    Abstract:

    Background: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. Objective: This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. Methods: The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. Results: The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. Conclusions: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial.

  • BESI-C logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/12/e16178/; License: Licensed by JMIR.

    Leveraging Smart Health Technology to Empower Patients and Family Caregivers in Managing Cancer Pain: Protocol for a Feasibility Study

    Abstract:

    Background: An estimated 60%-90% of patients with cancer experience moderate to severe pain. Poorly managed cancer pain negatively affects the quality of life for both patients and their family caregivers and can be a particularly challenging symptom to manage at home. Mobile and wireless technology (“Smart Health”) has significant potential to support patients with cancer and their family caregivers and empower them to safely and effectively manage cancer pain. Objective: This study will deploy a package of sensing technologies, known as Behavioral and Environmental Sensing and Intervention for Cancer (BESI-C), and evaluate its feasibility and acceptability among patients with cancer-family caregiver dyads. Our primary aims are to explore the ability of BESI-C to reliably measure and describe variables relevant to cancer pain in the home setting and to better understand the dyadic effect of pain between patients and family caregivers. A secondary objective is to explore how to best share collected data among key stakeholders (patients, caregivers, and health care providers). Methods: This descriptive two-year pilot study will include dyads of patients with advanced cancer and their primary family caregivers recruited from an academic medical center outpatient palliative care clinic. Physiological (eg, heart rate, activity) and room-level environmental variables (ambient temperature, humidity, barometric pressure, light, and noise) will be continuously monitored and collected. Behavioral and experiential variables will be actively collected when the caregiver or patient interacts with the custom BESI-C app on their respective smart watch to mark and describe pain events and answer brief, daily ecological momentary assessment surveys. Preliminary analysis will explore the ability of the sensing modalities to infer and detect pain events. Feasibility will be assessed by logistic barriers related to in-home deployment, technical failures related to data capture and fidelity, smart watch wearability issues, and patient recruitment and attrition rates. Acceptability will be measured by dyad perceptions and receptivity to BESI-C through a brief, structured interview and surveys conducted at deployment completion. We will also review summaries of dyad data with participants and health care providers to seek their input regarding data display and content. Results: Recruitment began in July 2019 and is in progress. We anticipate the preliminary results to be available by summer 2021. Conclusions: BESI-C has significant potential to monitor and predict pain while concurrently enhancing communication, self-efficacy, safety, and quality of life for patients and family caregivers coping with serious illness such as cancer. This exploratory research offers a novel approach to deliver personalized symptom management strategies, improve patient and caregiver outcomes, and reduce disparities in access to pain management and palliative care services.

  • Nurse-led care coordination service for people with multimorbidity. Source: Jacob Lund / Shutterstock; Copyright: Jacob Lund; URL: https://www.shutterstock.com/image-photo/senior-woman-walking-nursing-home-supported-423588130?src=yD4LMDRXbK_wSX4toWHHEg-1-46; License: Licensed by the authors.

    Development and Implementation of a Nurse-Led Model of Care Coordination to Provide Health-Sector Continuity of Care for People With Multimorbidity: Protocol...

    Abstract:

    Background: Innovative strategies are required to reduce care fragmentation for people with multimorbidity. Coordinated models of health care delivery need to be adopted to deliver consumer-centered continuity of care. Nurse-led services have emerged over the past 20 years as evidence-based structured models of care delivery, providing a range of positive and coordinated health care outcomes. Although nurse-led services are effective in a range of clinical settings, strategies to improve continuity of care across the secondary and primary health care sectors for people with multimorbidity have not been examined. Objective: To implement a nurse-led model of care coordination from a multidisciplinary outpatient setting and provide continuity of care between the secondary and primary health care sectors for people with multimorbidity. Methods: This action research mixed methods study will have two phases. Phase 1 includes a systematic review, stakeholder forums, and validation workshop to collaboratively develop a model of care for a nurse-led care coordination service. Phase 2, through a series of iterative action research cycles, will implement a nurse-led model of care coordination in a multidisciplinary outpatient setting. Three to five iterative action research cycles will allow the model to be refined and further developed with multiple data collection points throughout. Results: Pilot implementation of the model of care coordination commenced in October 2018. Formal study recruitment commenced in May 2019 and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by March 2020. Conclusions: Nursing, clinician, and patient outcomes and experiences with the nurse-led model of care coordination will provide a template to improve continuity of care between the secondary and primary health care systems. The model template may provide a future pathway for implementation of nurse-led services both nationally and internationally.

  • Light-emitting fabrics device. Source: Image created by the Authors; Copyright: Fabienne Lecomte; URL: https://www.researchprotocols.org/2019/12/e15026; License: Creative Commons Attribution (CC-BY).

    Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study):...

    Abstract:

    Background: Extramammary Paget disease of the vulva (EMPV) is a rare skin disorder commonly seen in postmenopausal Caucasian females that appears clinically as red, eczematous, pruriginous, and sometimes painful lesions. Although most cases are noninvasive, EMPV may be associated with an underlying or distant adenocarcinoma. EMPV has a chronic and relapsing course. The reference treatment is based on local surgical excision with negative margins. However, disease frequently extends far from the visible lesion, and surgical margins are frequently positive. Topical photodynamic therapy (PDT) is an established treatment modality for various dermatooncologic conditions. For example, red light irradiation with the Aktilite CL 128 and Metvixia (Galderma SA) as a photosensitizing molecule is a conventional protocol approved and widely used in Europe for PDT treatment of actinic keratosis, but this treatment is not yet widely used for EMPV because it has never clearly been demonstrated and is very painful. Objective: The aim of the study is to investigate the efficacy and safety relating to the medical device PAGETEX as a new painless PDT device using Metvixia in the treatment of vulvar Paget disease. The primary end point is the disease control rate at 3 months in 30% of the patients included, defined as stability, partial response, or total response, considering the extent of the lesion. Secondary end points are the disease control rate at 6 months, patient quality of life, level of pain experienced by the patient at each PDT session, severity of erythema, presence of protoporphyrin IX in Paget cells after each PDT session, and overall satisfaction level of the patient. Methods: The trial is an interventional, exploratory, simple group, nonrandomized, and single center (Lille University Hospital) study. Twenty-four patients will be included according to Simon’s optimal plan. Therapeutic procedure is based on a cycle of two PDT sessions with the PAGETEX medical device at 15-day intervals (Metvixia incubation during 30 minutes and 635 nm red light illumination with a low irradiance for 2 hours and 30 minutes for a total fluence of 12 J/cm²). At the assessment session, 3 months after inclusion, if the control of the disease is partial or null, the patient will complete another cycle of two PDT sessions. A final evaluation will be performed in all patients at 6 months. Analyses will be performed using SAS version 9.4 software (SAS Institute Inc). The characteristics of the patients at baseline will be described; qualitative variables will be described by numbers and percentages, and quantitative variables will be described either by the mean and standard deviation for Gaussian distribution or by the median and interquartile range (ie, 25th and 75th percentiles). The normality of the distributions will be tested by a Shapiro-Wilk test and checked graphically by histograms. Results: First patient was included in September 2019 and clinical investigations are planned until August 2022. The final results of this study are expected to be available in January 2023. Conclusions: This clinical trial aims to evaluate the efficacy and safety of a new PDT protocol for the treatment of EMPV. The PAGETEX device could become the treatment of choice if it is effective, painless, and easy to implement and use in hospitals. Clinical Trial: ClinicalTrials.gov NCT03713203; https://clinicaltrials.gov/ct2/show/NCT03713203

  • Selfback app in hand, self-management plan for LBP. Source: selfBACK project; Copyright: The selfBACK consortium; URL: http://www.researchprotocols.org/2019/12/e14720/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

    Abstract:

    Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. Clinical Trial: ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/old-man-showing-photos-phone-nurse_5199948.htm#page=1&query=nurse%20phone&position=3; License: Licensed by JMIR.

    Defining the Supportive Care Needs and Psychological Morbidity of Patients With Functioning Versus Nonfunctioning Neuroendocrine Tumors: Protocol for a Phase...

    Abstract:

    Background: Online information resources and support have been demonstrated to positively influence the well-being of people diagnosed with cancer. This has been explored in past literature for more common cancers; however, for rare cancers, such as neuroendocrine tumors (NETs), there are little to no support or resources available. Despite relatively good prognoses, the quality of life (QoL) of patients with NETs is significantly lower compared with samples of mixed cancer patients and the general population. Patients with NETs also typically report unclear and difficult pathways of disease management and treatment, given the heterogeneity of the diagnosis. There is a vital need to improve the availability of disease-specific information for this patient group and provide supportive care that is tailored to the unique needs of the NET patient population. Objective: This study described the protocol of a study aimed to better understand the outcomes and experiences of patients diagnosed with NETs and to develop and pilot test a nurse-led online and phone-based intervention that will provide tailored supportive care targeted to NET subgroups (functioning vs nonfunctioning). Methods: This is a multisite cohort with 3 phases, incorporating both quantitative and qualitative data collection. Phase 1 is a mixed methods prospective cohort study of NET patients identifying differences in patient experiences and priority of needs between NET subgroups. Phase 2 utilizes results from phase 1 to develop an online and nurse-led phone-based intervention. Phase 3 is to pilot test and evaluate the intervention’s acceptability, appropriateness, and feasibility. Results: Currently, the project is progressing through phase 1 and has completed recruitment. A total of 138 participants have been recruited to the study. To date, patient-reported outcome data from 123 participants at baseline and 87 participants at 6-month follow-up have been collected. Of these, qualitative data from semistructured interviews from 35 participants have also been obtained. Phase 2 and phase 3 of the project are yet to be completed. Conclusions: Limited research for patients with NETs suggests that QoL and patient experiences are significantly impaired compared with the general population. Furthermore, past research has failed to delineate how the clinical variability between those with functioning and nonfunctioning NETs impacts patient supportive care needs. This study will improve on the availability of disease-specific information as well as informing the design of a nurse-led online and phone-based supportive care intervention tailored for the unique needs of the NET patient population.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: https://www.researchprotocols.org/2019/12/e14119; License: Licensed by JMIR.

    Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and...

    Abstract:

    Background: Mindfulness meditation (MM) is a commonly used psychological intervention for pain, mood, and anxiety conditions, but can be challenging to practice with severe symptoms without proper training. The Mindfulness Meditation app (MMA) is a supportive training tool specifically developed for this study to aid in the practice of mindful breathing using a smartphone. Objective: This study aims to evaluate the psychophysiological effects of the MMA. Specifically, the study will assess parasympathetic functioning using heart rate variability (HRV; primary outcome), pain and mood symptoms, mind-wandering and present moment awareness, and breath focus in groups of undergraduate participants who self-report clinically-relevant symptoms of chronic pain (CP) and depression or anxiety (DA) and condition-free (CF) participants who do not meet either criteria. We hypothesize that use of the MMA by study groups will lead to improved HRV, pain, and mood symptoms compared with groups who do not use the app. Methods: This study is a two-arm randomized controlled trial (RCT) recruiting through a Web-based research participation pool at York University in Toronto, Canada. We are aiming for minimum 60 participants in each of CP, DA, and CF groups. Upon arriving to the laboratory, participants will be prescreened for classification into groups of CP, DA, or CF. Groups will be randomly assigned by a 1:1 ratio to an MMA (MMA+) condition or MM condition without the app (MMA−) after a brief stress induction procedure. In MMA+, participants will practice mindful breathing with a smartphone and press breath or other buttons at the sound of audio tones if their awareness was on breathing or another experience, respectively. HRV and respiration data will be obtained during rest (5 min), stress induction (5 min), and meditation conditions (12 min). Participants will complete psychological self-report inventories before and after the stress induction and after the meditation condition. Separate linear mixed models will be used to examine HRV and self-report inventories comparing groups and treatment conditions. Results: Recruitment for the study began in November 2017 and is expected to be completed in winter of 2019-2020. As of July 2019, 189 participants have been recruited. The study’s main findings are expected to reveal a positive pattern of HRV responses in the CP, DA, and CF groups, such that a significant increase in HRV (P<.05) is detected in those randomized to the MMA+ condition in comparison with those randomized to the MMA− condition. Conclusions: This RCT will contribute to the burgeoning health psychology literature regarding the clinical relevance of HRV in assessment and treatment of psychological and medical conditions. Furthermore, possible ways to inform designs of MM training tools delivered by apps and Web platforms for CP, depression, and anxiety conditions’ treatment will be discussed. Clinical Trial: Clinicaltrials.gov NCT03296007; https://clinicaltrials.gov/ct2/show/NCT03296007.

  • Source: Pixabay; Copyright: Pexels; URL: https://pixabay.com/photos/baby-child-cute-little-love-mom-1866621/; License: Licensed by the authors.

    Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Protocol for a Randomized Feasibility Pilot Trial

    Abstract:

    Background: Postpartum weight retention contributes to long-term weight gain and obesity for many women. Lifestyle interventions with numerous visits are logistically challenging for many postpartum women. Delivering a lifestyle intervention via social media may overcome logistic challenges to participation in in-person weight loss programs. Objective: The objective of this study is to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups with 72 postpartum women with overweight or obesity. Methods: Women with overweight or obesity who are 8 weeks to 12 months postpartum (N=72) will be recruited from the Hartford, Connecticut community. Eligible participants must also own an iPhone or Android smartphone and be an active Facebook user. Participants will receive a 6-month postpartum weight loss intervention based on the Diabetes Prevention Program lifestyle intervention and adapted for postpartum women. Participants will be randomized to receive the intervention via a private Facebook group or in-person group meetings. Assessments will occur at baseline, weekly during the intervention, at 6 months (at the end of the intervention), and at 12 months. Primary feasibility outcomes are recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures including measurement of costs to deliver and receive the intervention. We will describe 6- and 12-month weight loss as an exploratory outcome. Results: Recruitment began in September 2018. The first wave of the intervention began in February 2019, and the second wave of the intervention is expected to begin in fall 2019. We anticipate completing follow-up assessments in fall 2020, and results will be analyzed at that time. Conclusions: Results will inform the design of a large randomized controlled trial to assess whether delivering a postpartum weight loss intervention via Facebook is noninferior for weight loss and more cost-effective than delivering the intervention via traditional in-person groups.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/11/e13933/; License: Creative Commons Attribution (CC-BY).

    Development of an Early Warning System to Prevent Crises in the Palliative Home Care Setting of Patients and Their Informal Caregivers: Protocol for a Mixed...

    Abstract:

    Background: Most people wish to die at home, but most people in Switzerland die in hospitals or nursing homes. Family caregivers often offer support so patients with palliative care needs can stay at home for as long as possible. However, crises and unplanned hospital admissions often occur in this setting because of family caregiver strain and symptom severity in patients. The so-called smart devices such as wearables or smartphones offer the opportunity to continuously monitor certain parameters and recording symptom deteriorations. By providing professionals with this information in a timely manner, crises in the home could be avoided. Objective: The aim of this interdisciplinary study is to explore the symptom burden of people with palliative care needs who are cared for at home and to understand the development of crises in the home care setting. On the basis of the findings from this study, we will develop an early warning system to stabilize the home care situation and to prevent critical events from happening, thereby reducing avoidable hospitalizations. Methods: A mixed method study is being conducted consisting of 4 main consecutive phases: (1) developing the monitoring system; (2) pretesting the system and adapting it to user needs; (3) conducting the study in the palliative home care setting with approximately 40 patients; and (4) distinguishing symptom patterns from the collected data specific to crisis emergence, followed by the development of an early warning system to prevent such crises. In study phase 3, each patient will receive an upper arm sensor and a symptom diary to assess symptom burden related to patients and family caregivers. A within-case analysis will be conducted for each patient’s situation followed by a cross-case comparison to identify certain symptom patterns that may predict symptom deterioration (study phase 4). Results: The collaboration with the local mobile palliative care team for participant recruitment and data collection has been established. Recruitment is forthcoming. Conclusions: We expect the findings of this study to provide holistic insight into symptom burden and the well-being of patients with palliative care needs and of their family caregivers. This information will be used to develop an early warning system to avoid the occurrence of potential crises, thereby improving palliative care provision at home.

  • Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/11/e15426; License: Public Domain (CC0).

    Group Sex Events Among Cisgender Men Who Have Sex With Men: Cross-Sectional and Longitudinal Survey Study to Explore Participation and Risk-Taking Behaviors

    Abstract:

    Background: Group sex events (GSEs) are common among cisgender men who have sex with men (MSM), pose a unique risk profile for HIV and sexually transmitted disease (STD) transmission, and may be on the rise, in part because of Web-based networking platforms. However, collecting data on GSEs can be challenging, and many gaps exist in our knowledge about GSE participation among MSM. Objective: The objective of this study was to develop survey questions addressing aggregate and partner-specific group sex behaviors to measure prevalence of GSEs and associated risks in persons participating in Project Diagnostic Evaluation To Expand Critical Testing Technologies (DETECT), including MSM seeking HIV and STD testing at a public clinic in Seattle, Washington. Methods: We developed a computer self-assisted survey that included questions about participant demographics, sexual history, and risk behaviors, including group sex, as a part of Project DETECT, a Centers for Disease Control and Prevention–funded study evaluating point-of-care HIV tests. Aggregate and partner-specific questions asked about participation in all GSEs, threesomes, and four-or-more-somes including questions about number and HIV status of sex partners and condom use during the events. To evaluate question performance, we assessed the discrepancies in reporting between the aggregate and partner-specific questions, quantified question refusal rates, and calculated the additional time required to answer the GSE questions. Information about network density (number of partnerships of overlapping duration) was estimated and compared for MSM who did and did not report GSEs. Results: Among 841 visits by 690 MSM who were asked any group sex survey question, participation in a GSE of any type in the past 3 months was reported at 293 visits (293/841, 34.8%). We found that 9.0% (76/841) of MSM in the sample reported ≥1 four-or-more-some in the partner-specific questions but did not report in the aggregate. The proportion of refusals on any given aggregate GSE-related question ranged from 0% (0/273) to 10.6% (15/141) (median 2.6%) and partner-specific questions ranged from 0% (0/143) to 22% (5/23) (median 3.0%), with questions about four-or-more-somes having the highest proportions of refusals. Completing the aggregate group sex questions added 1 to 2 minutes and the partner-specific questions added an additional 2 to 4 minutes per partner to the total survey length. As expected, the partner-specific GSE questions documented higher density of sexual networks that was not captured by asking about total partner counts and overlap of specific partnerships. Conclusions: We found that the Project DETECT survey was able to obtain nuanced information about GSEs. The question skip patterns and consistency checks were effective, and survey fatigue was minimal. More research is needed on GSEs, and our survey represents a promising data collection tool to help fill gaps in knowledge about the subject.

  • Source: FreeDigitalPhotos.net; Copyright: Idea Go; URL: http://www.freedigitalphotos.net/images/Ideas_and_decision_m_g409-Puzzle_Solution_p18550.html; License: Licensed by the authors.

    Improving Team-Based Decision Making Using Data Analytics and Informatics: Protocol for a Collaborative Decision Support Design

    Abstract:

    Background: According to the September 2015 Institute of Medicine report, Improving Diagnosis in Health Care, each of us is likely to experience one diagnostic error in our lifetime, often with devastating consequences. Traditionally, diagnostic decision making has been the sole responsibility of an individual clinician. However, diagnosis involves an interaction among interprofessional team members with different training, skills, cultures, knowledge, and backgrounds. Moreover, diagnostic error is prevalent in the interruption-prone environment, such as the emergency department, where the loss of information may hinder a correct diagnosis. Objective: The overall purpose of this protocol is to improve team-based diagnostic decision making by focusing on data analytics and informatics tools that improve collective information management. Methods: To achieve this goal, we will identify the factors contributing to failures in team-based diagnostic decision making (aim 1), understand the barriers of using current health information technology tools for team collaboration (aim 2), and develop and evaluate a collaborative decision-making prototype that can improve team-based diagnostic decision making (aim 3). Results: Between 2019 to 2020, we are collecting data for this study. The results are anticipated to be published between 2020 and 2021. Conclusions: The results from this study can shed light on improving diagnostic decision making by incorporating diagnostics rationale from team members. We believe a positive direction to move forward in solving diagnostic errors is by incorporating all team members, and using informatics.

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    Open Peer Review Period: Nov 27, 2019 - Jan 22, 2020

    Background: Side effects of chemotherapy are feared by patients, specifically chemotherapy-induced nausea and vomiting. To relieve them, it is recommended to prescribe antiemetic drugs. However, some...

    Background: Side effects of chemotherapy are feared by patients, specifically chemotherapy-induced nausea and vomiting. To relieve them, it is recommended to prescribe antiemetic drugs. However, some patients report that they are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. Some chemotherapy for lung and digestive cancer patients is moderately or highly emitting. Objective: The primary objective of the present study is to assess the benefits of foot reflexology as a complement to conventional treatments on severity and frequency of chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives are quality of life, anxiety, and self-esteem. Methods: This study is an open label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogic scale, and the frequency of this between the two groups. Results: The results of this trial are expected in the first quarter of 2020. Patient enrolment is currently ongoing. Conclusions: The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend this use. The present study will provide evidence on the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Clinical Trial: The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018)

  • The cost-effectiveness of algorithms and artificial intelligence applied in health care: A scoping review research protocol

    Date Submitted: Nov 24, 2019

    Open Peer Review Period: Nov 24, 2019 - Jan 19, 2020

    Background: Given the rapid digitization of health care and abundance of available data, there is a great interest in how to leverage these advancements into evidence-based practice. Algorithms and ar...

    Background: Given the rapid digitization of health care and abundance of available data, there is a great interest in how to leverage these advancements into evidence-based practice. Algorithms and artificial intelligence have the potential to improve health care, reduce costs, and contribute to evidence-based practice. An in-depth examination of the available evidence is needed to elucidate the cost-effectiveness of algorithms and AI techniques applied in health care. Objective: The goal of this scoping review will be to map the literature on the cost-effectiveness of algorithms and AI techniques applied in health care. The current review protocol provides an overview of the steps taken to complete the review. Methods: The PRISMA-Scoping Review checklist will be used to guide the reporting of the scoping review. Three main concepts include: 1) health care costs; 2) algorithms and AI techniques; and 3) cost-effectiveness analysis. The following databases will be used: PubMed, Scopus, ACM Digital Library, IEEE, Google Scholar, Econlit, OpenGrey, and ProQuest Dissertations and Theses. Two researchers (SA and RHL) will independently screen the titles, abstracts, and full texts, while a third researcher (PS) will negotiate any discrepancies, until consensus is reached. Results: Article retrieval, data extraction, and interpretation are currently underway. Conclusions: Findings from the review may provide invaluable insights on the cost-effectiveness of algorithms and AI techniques applied in health care. Given that health care dollars are scarce, it is important to know which algorithms and AI techniques are worth the upfront investments. As a result, decision-makers will be able to identify which algorithms or AI technique would be of value for their specific context. This review will also identify key knowledge gaps in the literature and will provide next steps for future research. Clinical Trial: Not applicable - this is a scoping review.

  • Study protocol for the development of a taxonomy of communication techniques, strategies and aids used by healthcare professionals in healthcare consultations with patients

    Date Submitted: Oct 25, 2019

    Open Peer Review Period: Oct 25, 2019 - Dec 20, 2019

    Background: Currently, there is no available standardised taxonomy of defined communication techniques and strategies used by health professionals in patient consultations. It is problematic to identi...

    Background: Currently, there is no available standardised taxonomy of defined communication techniques and strategies used by health professionals in patient consultations. It is problematic to identify communication techniques contributing to effective healthcare professional and patient consultations and to replicate communication interventions in research. Objective: The first aim of this paper is to outline a protocol for systematic review of communication techniques, strategies and aids used by healthcare professionals in patient consultations as described in the literature. The secondary aim is to describe a protocol for the development and pilot of a taxonomy of communication techniques and strategies used by health professionals in patient consultations. Methods: A systematic review will be completed to identify eligible studies. Extracted strategies and techniques will be organised into a preliminary taxonomy by a multidisciplinary team. The preliminary taxonomy will be piloted by two groups: research assistants trained in taxonomy application and health professions and health professional students not trained in taxonomy use. The pilot will use custom developed video footage of health professional and patient interactions. Results of inter-rater validity and debriefing interview feedback will be used to inform the finalisation of the preliminary taxonomy by a multidisciplinary Delphi panel. Results: N/A Conclusions: This is the first known attempt to develop a defined and standardized taxonomy of communication techniques and strategies used by health professionals in patient consultations.

  • Understanding the Uptake of Big Data in Healthcare: A Multinational Mixed-Methods Study Protocol

    Date Submitted: Oct 24, 2019

    Open Peer Review Period: Oct 24, 2019 - Dec 19, 2019

    Background: Despite the high potential of big data, its applications in healthcare face manifold organizational, social, financial, and regulatory challenges. Big data embedment in the societal dimens...

    Background: Despite the high potential of big data, its applications in healthcare face manifold organizational, social, financial, and regulatory challenges. Big data embedment in the societal dimensions of healthcare systems is underrepresented in medical research. Little is known about integrating big data applications in the corporate routines of hospitals and other care providers. Equally little is understood about embedding big data applications in daily work practices and how they lead to actual improvements for healthcare actors, such as patients, care professionals, care providers, IT companies, payers and society. Objective: This planned study aims to provide an integrated analysis of big data applications, focusing on the interrelations between concrete big data experiments, organizational routines and relevant systemic and societal dimensions. To understand the similarities and differences between interactions in various contexts, the study covers 12 big data pilot projects in eight European countries, each with its own healthcare system. Workshops will be held with stakeholders to discuss the findings, our recommendations, and their implementation. Dissemination is supported by visual representations developed to share the knowledge gained Methods: This study will utilize a mixed-methods approach that combines performance measurements, interviews, document analysis and co-creation workshops. Analysis will be structured around four key dimensions: ‘performance’, ‘embedding’, ‘legitimation’ and ‘value creation’. Data and their interrelations across the dimensions will be synthesized per application and per country. Results: The multidisciplinary focus of this study enables us to combine insights from several social sciences (health policy analysis, business administration, innovation studies, organization studies, ethics and health services research) to advance a holistic understanding of big data value realization. The multinational character enables comparative analysis across eight European countries: Austria, France, Germany, Ireland, the Netherlands, Spain, Sweden, and the United Kingdom. Given that national and organizational contexts change over time, note that it will not be possible to isolate the factors and actors that explain the implementation of the big data applications. The visual representations developed for dissemination purposes will help to reduce complexity and clarify the relations between the various dimensions. Conclusions: This study will develop an integrated approach to big data applications that considers the interrelations between concrete big data experiments, organizational routines and relevant systemic and societal dimensions. . Clinical Trial: This study is not a trial.

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