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  RCTs - Protocols/Proposals (funded,...

  Dec 7, 2018

  A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial...

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  Authors List:

  • Michael P Dorsch  
  • Lawrence C An  
  • Scott L Hummel  

  Abstract:

  Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. Trial Registration: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) International Registered Report Identifier (IRRID): PRR1-10.2196/11282

  • JMIR Res Protoc 2018;7(12):e11282

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  NHS funded proposals with peer-review...

  Dec 7, 2018

  An Electronic Clinical Decision Support System for the Assessment and Management of Suicidality in Primary Care: Protocol for a Mixed-Methods Study

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  Authors List:

  • Matthew Horrocks  
  • Maria Michail  
  • Aimee Aubeeluck  
  • Nicola Wright  
  • Richard Morriss  

  Abstract:

  Background: Suicide is a global public health concern, but it is preventable. Increased contact with primary care before the suicide or attempted suicide raises opportunities for intervention and prevention. However, suicide assessment and management are areas that many general practitioners (GPs) find particularly challenging. Previous research has indicated significant variability in how GPs understand, operationalize, and assess suicide risk, which subsequently has an impact on clinical decision making. Clinical decision support systems (CDSS) have been widely implemented across different health care settings, including primary care to support practitioners in clinical decision making. A CDSS may reduce inconsistencies in the identification, assessment, and management of suicide risk by GPs by guiding them through the consultation and generating a risk assessment plan that can be shared with a service user or with specialized mental health services. Objective: Our aim is to co-develop and test with end users (eg, GPs, primary care attendees, mental health professionals) an electronic clinical decision support system (e-CDSS) to support GPs in the identification, assessment, and management of suicidality in primary care. Methods: Ours is an ongoing embedded mixed-methods study with four phases: (1) qualitative interviews with GPs to explore their views on the content, format, and use of the e-CDSS, as well as consultation with two service-user advisory groups (people aged ≤25 and people aged ≥25) to inform the content of the e-CDSS including phrasing of items and clarity; (2) participatory co-production workshops with GPs, service users, and clinical experts in suicidality to determine the content and format of the e-CDDS; gain consensus of the relevance of items; establish content validity and identify pathways to implementation, using the Consolidated Framework for Implementation Research; (3) building the e-CDSS so that it guides the GP through a consultation; and (4) usability testing of the e-CDSS with GPs and service users in one primary care practice involving a nonlive and a live stage. Results: The study was funded for four years, to take place between 2015 and 2019, and is currently completing phase 4 data collection. The first results are expected to be submitted for publication in June 2019. The findings will enable us to evaluate the feasibility, acceptability, and usability of a suicide-specific, electronic, guided decision support system in primary care. Conclusions: This study will be the first to explore the feasibility, acceptability, and usability of an electronic, guided decision support system for use in primary care consultations for the improved assessment and management of suicidality. International Registered Report Identifier (IRRID): RR1-10.2196/11135

  • JMIR Res Protoc 2018;7(12):e11135

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  Non-Randomized Study Protocols and...

  Dec 7, 2018

  Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study

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  Authors List:

  • Nathan Smischney  
  • Rahul Kashyap  
  • Mohamed Seisa  
  • Darrell Schroeder  
  • Daniel Diedrich  

  Abstract:

  Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation occurs, the current practice is largely unknown. This is relevant, as advances in airway equipment (ie, video laryngoscopes) have become more prevalent, leading to possible improvement of care delivered during this process. In addition to new devices, a greater emphasis on airway plans and choices in sedation have evolved, although the influence on patient morbidity and mortality is largely unknown. Objective: This study aims to derive and validate prediction models for immediate airway and hemodynamic complications of intensive care unit intubations. Methods: A multicenter, observational, prospective study of adult critically ill patients admitted to both medical and surgical intensive care units (ICUs) was conducted. Participating ICU sites were located throughout eight health and human services regions of the United States for which endotracheal intubation was needed. A steering committee composed of both anesthesia and pulmonary critical care physicians proposed a core set of data variables. These variables were incorporated into a data collection form to be used within the multiple, participating ICUs across the United States during the time of intubation. The data collection form consisted of two basic components, focusing on airway management and hemodynamic management. The form was generated using RedCap and distributed to the participating centers. Quality checks on the dataset were performed several times with each center, such that they arrived at less than 10% missing values for each data variable; the checks were subsequently entered into a database. Results: The study is currently undergoing data analysis. Results are expected in November 2018 with publication to follow thereafter. The study protocol has not yet undergone peer review by a funding body. Conclusions: The overall goal of this multicenter prospective study is to develop a scoring system for peri-intubation, hemodynamic, and airway-related complications so we can stratify those patients at greatest risk for decompensation as a result of these complications. This will allow critical care physicians to be better prepared in addressing these occurrences and will allow them to improve the quality of care delivered to the critically ill. Trial Registration: ClinicalTrials.gov NCT02508948; https://clinicaltrials.gov/ct2/show/NCT02508948 (Archived by WebCite at http://www.webcitation.org/73Oj6cTFu) International Registered Report Identifier (IRRID): RR1-10.2196/11101

  • JMIR Res Protoc 2018;7(12):e11101

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  RCTs - Protocols/Proposals (funded,...

  Dec 6, 2018

  Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Francisco Jódar-Sánchez  
  • Laura Carrasco Hernández  
  • Francisco J Núñez-Benjumea  
  • Marco Antonio Mesa González  
  • Jesús Moreno Conde  
  • Carlos Luis Parra Calderón  
  • Luis Fernandez-Luque  
  • Santiago Hors-Fraile  
  • Anton Civit  
  • Panagiotis Bamidis  
  • Francisco Ortega-Ruiz  

  Abstract:

  Background: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). Methods: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. Results: Of 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. Conclusions: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). International Registered Report Identifier (IRRID): PRR1-10.2196/12464

  • JMIR Res Protoc 2018;7(12):e12464

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  RCTs - Protocols/Proposals (funded,...

  Dec 6, 2018

  Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic...

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  Authors List:

  • Katsuhiro Mizuno  
  • Takayuki Abe  
  • Junichi Ushiba  
  • Michiyuki Kawakami  
  • Tomomi Ohwa  
  • Kazuto Hagimura  
  • Miho Ogura  
  • Kohei Okuyama  
  • Toshiyuki Fujiwara  
  • Meigen Liu  

  Abstract:

  Background: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. Objective: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. Methods: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. Results: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. Conclusions: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. Trial Registration: UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) International Registered Report Identifier (IRRID): DERR1-10.2196/12339

  • JMIR Res Protoc 2018;7(12):e12339

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  Non-randomized Protocols and Methods...

  Dec 4, 2018

  The Internet of Things in Health Care in Oxford: Protocol for Proof-of-Concept Projects

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  Authors List:

  • Edward Meinert  
  • Michelle Van Velthoven  
  • David Brindley  
  • Abrar Alturkistani  
  • Kimberley Foley  
  • Sian Rees  
  • Glenn Wells  
  • Nick de Pennington  

  Abstract:

  Background: Demands on health services across are increasing because of the combined challenges of an expanding and aging population, alongside complex comorbidities that transcend the classical boundaries of modern health care. Continuing to provide and coordinate care in the current manner is not a viable route to sustain the improvements in health outcomes observed in recent history. To ensure that there continues to be improvement in patient care, prevention of disease, and reduced burden on health systems, it is essential that we adapt our models of delivery. Providers of health and social care are evolving to face these pressures by changing the way they think about the care system and, importantly, how to involve patients in the planning and delivery of services. Objective: The objective of this paper is to provide (1) an overview of the current state of Internet of Things (IoT) and key implementation considerations, (2) key use cases demonstrating technology capabilities, (3) an overview of the landscape for health care IoT use in Oxford, and (4) recommendations for promoting the IoT via collaborations between higher education institutions and industry proof-of-concept (PoC) projects. Methods: This study describes the PoC projects that will be created to explore cost-effectiveness, clinical efficacy, and user adoption of Internet of Medical Things systems. The projects will focus on 3 areas: (1) bring your own device integration, (2) chronic disease management, and (3) personal health records. Results: This study is funded by Research England’s Connecting Capability Fund. The study started in March 2018, and results are expected by the end of 2019. Conclusions: Embracing digital solutions to support the evolution and transformation of health services is essential. Importantly, this should not simply be undertaken by providers in isolation. It must embrace and exploit the advances being seen in the consumer devices, national rollout of high-speed broadband services, and the rapidly expanding medical device industry centered on mobile and wearable technologies. Oxford University Hospitals and its partner providers, patients, and stakeholders are building on their leading position as an exemplar site for digital maturity in the National Health Service to implement and evaluate technologies and solutions that will capitalize on the IoT. Although early in the application to health, the IoT and the potential it provides to make the patient a partner at the center of decisions about care represent an exciting opportunity. If achieved, a fully connected and interoperable health care environment will enable continuous acquisition and real-time analysis of patient data, offering unprecedented ability to monitor patients, manage disease, and potentially deliver early diagnosis. The clinical benefit of this is clear, but additional patient benefit and value will be gained from being able to provide expert care at home or close to home. International Registered Report Identifier (IRRID): DERR1-10.2196/12077

  • JMIR Res Protoc 2018;7(12):e12077

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  Surveillance Systems

  Dec 4, 2018

  Acceptance and Resistance of New Digital Technologies in Medicine: Qualitative Study

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  Authors List:

  • Sabur Safi  
  • Thomas Thiessen  
  • Kurt JG Schmailzl  

  Abstract:

  Background: This study discusses the acceptance of new medical technologies in health care settings and resistance to these technologies from hospitals, doctors’ surgical centers, electronic health (eHealth) centers, and related institutions. We suggest a novel method of identifying factors that influence the acceptance of, and resistance to, new technologies by medical staff and patients. Objective: The objective of this study was to determine and evaluate the factors that influence acceptance and resistance to achieve a successful implementation of new technologies. Methods: The target group was patients residing in Brandenburg and major stakeholders in the local health care structure, for instance, medical institutions and medical professionals. The process relies on 3 models: the technology acceptance model, the unified technology acceptance and use of technology model, and the theory of technical innovation diffusion. Qualitative methodology was employed in this study, and an exploratory design was adopted to gain new insights into a poorly understood phenomenon in the German context. This enabled the researcher to take a flexible approach toward exploring a wide range of secondary data and to choose a different approach when unexpected information emerged. Content analysis was used to identify and interpret the data, and the researcher assured that the meaning associated with the information has concurred with that of the original source. Results: This study confirmed that adoption of new technologies in health care depended on individual opinions of the factors relating to them. Some medical professionals believed that technology would interfere with their ability to make independent diagnoses and their relationships with patients. Doctors also feared that technology was a means of management control. In contrast, other medical staff welcomed technology because it provided them with more opportunities to interact with patients and their carers. Generally, patients were more enthusiastic about technology than medical professionals and health care managers because it allowed them to have greater autonomy in selecting health care options. The need for all groups to be involved in the development of the new health care approach was an important outcome, otherwise resistance to it was likely to be greater. In other words, the strategy for change management was the indicator of success or failure. Therefore, following our analysis, a number of practical precepts emerged that could facilitate user acceptance of digital solutions and innovative medical technologies. Conclusions: The acceptance of digital solutions and innovative medical technology by patients and professionals relies on understanding their anxieties and feelings of insecurity. The process will take time because individuals accept change at different rates. Hence, the development of an extensive user community to fully and successfully implement eHealth is less likely in the short term; however, this should not prevent the push for changes in health care technology.

  • JMIR Res Protoc 2018;7(12):e11072

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  Early Reports

  Nov 29, 2018

  Evaluating the Impacts of Methylsulfonylmethane on Allergic Rhinitis After a Standard Allergen Challenge: Randomized Double-Blind Exploratory Study

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  Authors List:

  • Susan Hewlings  
  • Douglas S Kalman  

  Abstract:

  Background: The sulfur-containing compound methylsulfonylmethane (MSM) has been used as a dietary supplement for a variety of reported health benefits. Clinical observations and case studies have indicated that MSM may help alleviate allergic rhinitis; however, this effect has not been evaluated under controlled conditions. Objective: This study aimed to determine the effects of MSM consumption on allergic rhinitis symptoms after provocation with a standardized allergen. Methods: We recruited healthy participants with a history of allergic nasal congestion to participate in a randomized, double-blind, adaptive-design study. Participants were administered a standardized allergen in clinic to determine the presence or absence of an allergic response. Participant responses were recorded using a recognized measure of nasal patency, peak nasal inspiratory flow (PNIF), and by a visual analog scale to score the severity of their allergy-related nasal symptoms. After we collected baseline nasal responses to allergen, followed by a 1-week washout period, participants returned to the clinic and were exposed to allergen after taking an acute high dose of 12 g of MSM. We then randomly assigned participants to a lower dose of MSM (1 g, 3 g, or 6 g), which they consumed once a day for 14 days. Participants returned to the clinic for repeat assessments while again taking their assigned daily dose of MSM. Results: All MSM treatment courses significantly reduced visual analog scale average nasal symptoms in a longitudinal comparison across all participants, with low-dose treatments decreasing symptoms by 53.72% (P=.001), and an acute 12-g dose decreasing symptoms by 22.49% (P=.03). Although the acute dose of MSM did not yield significant changes in nasal patency, low “everyday” doses significantly relieved nasal obstruction as indicated by a 17.32% (P=.02) increase in PNIF across all participants. The most effective dose across all measurements was daily consumption of 3 g of MSM, which significantly decreased all nasal symptoms (nasal obstruction, rhinorrhea, watery or itchy eyes and nose, and sneezing) and further was found to significantly (P=.01) increase PNIF. Conclusions: The MSM study product provided significant relief of allergic rhinitis symptoms and objective nasal obstruction measurements without the occurrence of adverse events. Oral consumption of the study product may reduce the symptoms and onset of allergic rhinitis without the side effects associated with standard-care medication. Trial Registration: ClinicalTrials.gov NCT02342483; https://clinicaltrials.gov/ct2/show/NCT02342483 (Archived by WebCite at http://www.webcitation.org/73vLKNvAp)

  • JMIR Res Protoc 2018;7(11):e11139

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  Non-randomized Protocols and Methods...

  Nov 28, 2018

  User Perspectives of a Web-Based Data-Sharing Platform (Open Humans) on Ethical Oversight in Participant-Led Research: Protocol for a Quantitative Study

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  Authors List:

  • Marta Fadda  
  • Anna Jobin  
  • Alessandro Blasimme  
  • Bastian Greshake Tzovaras  
  • Mad Price Ball  
  • Effy Vayena  

  Abstract:

  Background: Advances in medicine rely to a great extent on people’s willingness to share their data with researchers. With increasingly widespread use of digital technologies, several Web-based communities have emerged aiming to enable their users to share large amounts of data, some of which can possibly be employed for research purposes by scientists, or to conduct participant-led research (PLR). Scholarship has recently addressed the necessity of interrogating how existing ethical standards can and should be applied and adapted in view of the specificities of such Web-based activities. So far, no study has explored participants’ beliefs about and attitudes toward ethical oversight when it comes to platforms that involve medical data sharing. Objective: This paper presents the protocol for a survey study aimed at understanding users’ beliefs about Web-based data-sharing platforms regarding how research ethics principles should be applied in such a setting. Furthermore, the study aims at quantitatively assessing the relationship between participants’ perspectives on ethical oversight and other variables such as previous participation in research, beliefs about data sharing, and attitudes toward self-experimentation. Methods: We are conducting a Web-based survey with users of a popular Web-based data-sharing platform, Open Humans. The survey has been sent to approximately 4640 users registered for the Open Humans newsletter. To fill out the survey, participants need to have an account on Open Humans. We expect a 5%-10% response rate (between 200 and 400 completed surveys out of approximately 4000 survey invitations sent). Independent variables include past data-sharing behavior and intention, beliefs about data sharing, past participation in research, attitudes toward self-experimentation, perceived knowledge of the platform’s guidelines and terms, perceived importance of having transparent guidelines, and governance-related beliefs. The main dependent variable is participants’ expectations regarding who should ensure that ethical requirements are met within research projects conducted on open data-sharing platforms, based on Emanuel et al’s ethical framework. We will use chi-square tests to assess the relationship between participants’ expectations regarding ethical oversight and their past behavior, future intentions, beliefs, attitudes, and knowledge. Results: Data collection started on June 13, 2018. A reminder to fill out the survey was sent to participants in mid-July. We expect to gain insights on users’ perspectives on the ethical oversight of Web-based data-sharing platforms and on the associated experiences, beliefs, and sociodemographic characteristics. Conclusions: When digital tools allow people to engage in PLR including medical data, understanding how people interpret and envision the ethical oversight of their data-sharing practices is crucial. This will be the first study to explore users’ perspectives on ethical oversight of Web-based data-sharing platforms. The results will help inform the development of a framework that can be employed for platforms hosting various kinds of research projects to accommodate participants’ ethical oversight needs. International Registered Report Identifier (IRRID): RR1-10.2196/10939

  • JMIR Res Protoc 2018;7(11):e10939

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  RCTs - Protocols/Proposals (non-eHealth)

  Nov 26, 2018

  Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Andreas Älgå  
  • Sidney Wong  
  • Rawand Haweizy  
  • Kalle Conneryd Lundgren  
  • Johan von Schreeb  
  • Jonas Malmstedt  

  Abstract:

  Background: In armed conflict, injuries commonly affect the extremities and contamination with foreign material often increases the risk of infection. The use of negative-pressure wound therapy has been described in the treatment of acute conflict-related wounds, but reports are retrospective and with limited follow-up. Objective: The objective of this study is to investigate the effectiveness and safety of negative-pressure wound therapy use in the treatment of patients with conflict-related extremity wounds. Methods: This is a multisite, superiority, pragmatic randomized controlled trial. We are considering for inclusion patients 18 years of age and older who are presenting with a conflict-related extremity wound within 72 hours after injury. Patients are block randomly assigned to either negative-pressure wound therapy or standard treatment in a 1:1 ratio. The primary end point is wound closure by day 5. Secondary end points include length of stay, wound infection, sepsis, wound complications, death, and health-related quality of life. We will explore economic outcomes, including direct health care costs and cost effectiveness, in a substudy. Data are collected at baseline and at each dressing change, and participants are followed for up to 3 months. We will base the primary statistical analysis on intention-to-treat. Results: The trial is ongoing. Patient enrollment started in June 2015. We expect to publish findings from the trial by the end of 2019. Conclusions: To the best of our knowledge, there has been no randomized trial of negative-pressure wound therapy in this context. We expect that our findings will increase the knowledge to establish best-treatment strategies. Trial Registration: ClinicalTrials.gov NCT02444598; http://clinicaltrials.gov/ct2/show/NCT02444598 (Archived by WebCite at http://www.webcitation.org/72hjI2XNX) International Registered Report Identifier (IRRID): DERR1-10.2196/12334

  • JMIR Res Protoc 2018;7(11):e12334

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  NHMRC/ARC funded proposals with...

  Nov 23, 2018

  Simulation Modeling for Psychiatric Service Planning: Protocol for a Mixed-Methods Study

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  Authors List:

  • Katrina M Long  
  • Graham N Meadows  

  Abstract:

  Background: Mental health service managers must take into account multiple factors when making decisions about the best way to deliver care to clients across increasingly larger service areas. This task is made more difficult by the lack of evidence and tools historically available to inform these decisions. In recent decades, the increasing availability of epidemiological and service use data for mental illness has solved the problem of evidence, but there still exists a challenge to make these data easily accessible and understandable for managers. Objective: This study aims to develop a simulation modeling tool to allow managers to explore various service configurations in virtual reality, enabling predictions to be made about the cost and quality of care. Methods: This is a longitudinal, mixed-methods case study, comprising overlapping intervention and evaluation phases. In partnership with senior managers of a mental health program, the researchers will develop a series of simulation models in Arena to address key strategic issues facing the service. Thematic and content analyses of semistructured interviews, meeting observations, and document analysis will be used to evaluate the process of model implementation and the outcomes for both researchers and managers. The study is being conducted in Australia. Results: Data collection has been ongoing since late 2013. To date, 3 prototype simulation models have been developed and presented to senior managers, and 18 evaluation interviews have been conducted. The project is expected to conclude in late 2018. Conclusions: Findings of this study have the potential to shape decision making in mental health service delivery, by providing key examples of how to integrate patient data using simulation modeling. In addition, the results will provide key insights into how researchers and consultants can effectively implement simulation modeling in real-world health care organizations. International Registered Report Identifier (IRRID): PRR1-10.2196/11119

  • JMIR Res Protoc 2018;7(11):e11119

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  Systematic Review Protocols

  Nov 21, 2018

  Clients’ Experiences With Internet-Based Psychological Treatments for Mental Disorders: Protocol for a Metasynthesis of Qualitative Studies

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  Authors List:

  • Javier Fernández-Álvarez  
  • Amanda Díaz-García  
  • Mª Dolores Vara  
  • Guadalupe Molinari  
  • Desirée Colombo  
  • Giuseppe Riva  
  • Rosa M Baños  
  • Cristina Botella  

  Abstract:

  Background: Given the rise of internet-based treatments as an effective therapeutic tool for psychological disorders, it is necessary to carry out research that examines clients’ experiences with this type of intervention. The qualitative methodology has been found to be useful for analyzing clients’ perceptions in terms of facilitators and barriers, acceptability, and negative effects of internet-based treatments. However, a lack of integration of these primary studies has prevented their findings from being applied to new research and in clinical practice. Objective: The objective of this paper is to describe the protocol for a metasynthesis of qualitative studies exploring the experiences of clients who underwent an internet-based treatment. Methods: Elliot and Timulak’s metasynthesis approach will be used to review and synthesize qualitative studies related to client experiences in terms of the barriers and facilitators they perceived when undergoing internet-based treatment. For each search string, the features in the Sample, Phenomenon of Interest, Design, Evaluation, Research type (SPIDER) tool will be considered. Electronic databases (PubMed, PsycINFO, and Web of Science) will be searched. Two independent reviewers will analyze the material in order to determine whether the eligibility criteria are fulfilled. Findings will make it possible to create a hierarchy of domains in terms of their relevance across all the primary studies. The data obtained from primary studies will be cross-analyzed using descriptive and interpretative procedures. Results: The search strategy is currently being conducted. First results are expected to be submitted for publication in 2019. Conclusions: We will develop conceptual framework of the barriers and facilitators perceived by clients and propose their implications and recommendations for clinical practice, research, and training. Trial Registration: PROSPERO CRD42018079894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=79894 (Archived by WebCite at http://www.webcitation.org/73C6OtlS7). International Registered Report Identifier (IRRID): PRR1-10.2196/9722

  • JMIR Res Protoc 2018;7(11):e183

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