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JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes 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.

JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)

JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions

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 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 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 proposal 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)

 
 

Recent Articles:

  • Trial logo. Source: The Authors; Copyright: Raimondo Ascione; URL: http://www.researchprotocols.org/2017/6/e119/; License: Creative Commons Attribution (CC-BY).

    The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled...

    Abstract:

    Background: Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. Objective: The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to “fit for discharge”, incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. Methods: In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann’s solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were “fit for discharge”, which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Results: Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. Conclusions: VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK)

  • Participant engaging in active video game play on the adapted balance board. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/6/e116/; License: Creative Commons Attribution (CC-BY).

    Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol

    Abstract:

    Background: Individuals with disabilities are typically more sedentary and less fit compared to their peers without disabilities. Furthermore, engaging in physical activity can be extremely challenging due to physical impairments associated with disability and fewer opportunities to participate. One option for increasing physical activity is playing active video games (AVG), a category of video games that requires much more body movement for successful play than conventional push-button or joystick actions. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in physical activity. Objective: Our aim was to compare the effect of off-the-shelf and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with physical disabilities, specifically those with mobility impairments (ie, unable to stand, balance issues, poor motor control, unable to use lower extremity for gameplay). The gaming controllers to be evaluated include off-the-shelf and adapted versions of the Wii Fit balance board and gaming mat. Methods: Participants (10-60 years old) came to the laboratory a total of three times. During the first visit, participants completed a functional assessment and became familiar with the equipment and games to be played. For the functional assessment, participants performed 18 functional movement tasks from the International Classification of Functioning, Disability, and Health. They also answered a series of questions from the Patient Reported Outcomes Measurement Information System and Quality of Life in Neurological Conditions measurement tools, to provide a personal perspective regarding their own functional ability. For Visit 2, metabolic data were collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played. Results: Enrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017. Conclusions: We hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions. Trial Registration: ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7)

  • Source: Unsplash; Copyright: freestocks.org; URL: https://unsplash.com/search/phone?photo=m7zKB91brGo; License: Licensed by JMIR.

    Phone-Based Interventions in Adolescent Psychiatry: A Perspective and Proof of Concept Pilot Study With a Focus on Depression and Autism

    Abstract:

    Background: Telemedicine has emerged as an innovative platform to diagnose and treat psychiatric disorders in a cost-effective fashion. Previous studies have laid the functional framework for monitoring and treating child psychiatric disorders electronically using videoconferencing, mobile phones (smartphones), and Web-based apps. However, phone call and text message (short message service, SMS) interventions in adolescent psychiatry are less studied than other electronic platforms. Further investigations on the development of these interventions are needed. Objective: The aim of this paper was to explore the utility of text message interventions in adolescent psychiatry and describe a user feedback-driven iterative design process for text message systems. Methods: We developed automated text message interventions using a platform for both depression (EpxDepression) and autism spectrum disorder (ASD; EpxAutism) and conducted 2 pilot studies for each intervention (N=3 and N=6, respectively). The interventions were prescribed by and accessible to the patients’ healthcare providers. EpxDepression and EpxAutism utilized an automated system to triage patients into 1 of 3 risk categories based on their text responses and alerted providers directly via phone and an online interface when patients met provider-specified risk criteria. Rapid text-based feedback from participants and interviews with providers allowed for quick iterative cycles to improve interventions. Results: Patients using EpxDepression had high weekly response rates (100% over 2 to 4 months), but exhibited message fatigue with daily prompts with mean (SD) overall response rates of 66.3% (21.6%) and 64.7% (8.2%) for mood and sleep questionnaires, respectively. In contrast, parents using EpxAutism displayed both high weekly and overall response rates (100% and 85%, respectively, over 1 to 4 months) that did not decay significantly with time. Monthly participant feedback surveys for EpxDepression (7 surveys) and EpxAutism (18 surveys) preliminarily indicated that for both interventions, daily messages constituted the “perfect amount” of contact and that EpxAutism, but not EpxDepression, improved patient communication with providers. Notably, EpxDepression detected thoughts of self-harm in patients before their case managers or caregivers were aware of such ideation. Conclusions: Text-message interventions in adolescent psychiatry can provide a cost-effective and engaging method to track symptoms, behavior, and ideation over time. Following the collection of pilot data and feedback from providers and patients, larger studies are already underway to validate the clinical utility of EpxDepression and EpxAutism. Trial Registration: Clinicaltrials.gov NCT03002311; https://clinicaltrials.gov/ct2/show/NCT03002311 (Archived by WebCite at http://www.webcitation.org/6qQtlCIS0)

  • Database screenshot. Source: The Authors and Placeit.net (montage); Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/e115/; License: Creative Commons Attribution (CC-BY).

    A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey

    Abstract:

    Background: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. Objective: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. Methods: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). Results: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. Conclusions: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. Trial Registration: Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v)

  • Duke Heart Center Patient Survey. Source: The Authors; Copyright: Hanzhang Xu; URL: http://www.researchprotocols.org/2017/6/e118/; License: Creative Commons Attribution (CC-BY).

    Identifying Nonclinical Factors Associated With 30-Day Readmission in Patients with Cardiovascular Disease: Protocol for an Observational Study

    Abstract:

    Background: Cardiovascular disease (CVD) is the leading cause of hospitalization in older adults and high readmission rates have attracted considerable attention as actionable targets to promote efficiency in care and to reduce costs. Despite a plethora of research over the past decade, current strategies to predict readmissions have been largely ineffective and efforts to identify novel clinical predictors have been largely unsuccessful. Objective: The objective of this study is to examine a wide array of socioeconomic, psychosocial, behavioral, and clinical factors to predict risks of 30-day hospital readmission in cardiovascular patients. Methods: The study includes patients (aged 18 years and older) admitted for the treatment of cardiovascular-related illnesses at the Duke Heart Center, which is among the nation’s largest and top-ranked cardiovascular care hospitals. The study uses a novel standardized survey to ascertain data on a comprehensive array of patient characteristics that will be linked to their electronic medical records. A series of univariate and multivariate models will be used to estimate the associations between the patient-level factors and 30-day readmissions. The performance of the risk models will be examined based on 2 components of accuracy—model calibration and discrimination—to determine how closely the predicted outcome agrees with the observed (actual) outcome and how well the model distinguishes patients who were readmitted and those who were not. The purpose of this paper is to present the protocol for the implementation of this study. Results: The study was launched in February 2014 and is actively recruiting patients from the Heart Center. Approximately 550 patients have been enrolled to date and the study is expected to continue recruitment until February 2018. Preliminary results show that participants in the study were aged 63.6 years on average (SD 14.0), predominately male (61.2%), and primarily non-Hispanic white (64.6%) or non-Hispanic black (31.7%). The demographic characteristics of study participants were not significantly different from all patients admitted to the Heart Center during this period with an average age of 65.0 years (SD 15.3) and predominately male (58.6%), non-Hispanic white (62.9%) or non-Hispanic black (31.8%) The integration of the interview data with clinical data from the patient electronic medical records is currently underway. The study has received funding and ethical approval. Conclusions: Many US hospitals continue to struggle with high readmission rates in patients with cardiovascular disease. The primary objective of this study is to collect and integrate a comprehensive array of patient attributes to develop a powerful yet parsimonious model to stratify risks of rehospitalization in cardiovascular patients. The results of this research also have the potential to identify actionable targets for tailored interventions to improve patient outcomes.

  • Preterm infant receiving PULSED NTrainer stimulation during gavage feeding in the neonatal intensive care unit, with a nasogastric tube. Source: The Authors; Copyright: Innara Health, Inc.; URL: http://www.innarahealth.com/; License: Creative Commons Attribution (CC-BY).

    Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants: Randomized Controlled Trial

    Abstract:

    Background: Despite numerous medical advances in the care of at-risk preterm neonates, oral feeding still represents one of the first and most advanced neurological challenges facing this delicate population. Objective, quantitative, and noninvasive assessment tools, as well as neurotherapeutic strategies, are greatly needed in order to improve feeding and developmental outcomes. Pulsed pneumatic orocutaneous stimulation has been shown to improve nonnutritive sucking (NNS) skills in preterm infants who exhibit delayed or disordered nipple feeding behaviors. Separately, the study of the salivary transcriptome in neonates has helped identify biomarkers directly linked to successful neonatal oral feeding behavior. The combination of noninvasive treatment strategies and transcriptomic analysis represents an integrative approach to oral feeding in which rapid technological advances and personalized transcriptomics can safely and noninvasively be brought to the bedside to inform medical care decisions and improve care and outcomes. Objective: The study aimed to conduct a multicenter randomized control trial (RCT) to combine molecular and behavioral methods in an experimental conceptualization approach to map the effects of PULSED somatosensory stimulation on salivary gene expression in the context of the acquisition of oral feeding habits in high-risk human neonates. The aims of this study represent the first attempt to combine noninvasive treatment strategies and transcriptomic assessments of high-risk extremely preterm infants (EPI) to (1) improve oral feeding behavior and skills, (2) further our understanding of the gene ontology of biologically diverse pathways related to oral feeding, (3) use gene expression data to personalize neonatal care and individualize treatment strategies and timing interventions, and (4) improve long-term developmental outcomes. Methods: A total of 180 extremely preterm infants from three neonatal intensive care units (NICUs) will be randomized to receive either PULSED or SHAM (non-pulsing) orocutaneous intervention simultaneous with tube feedings 3 times per day for 4 weeks, beginning at 30 weeks postconceptional age. Infants will also be assessed 3 times per week for NNS performance, and multiple saliva samples will be obtained each week for transcriptomic analysis, until infants have achieved full oral feeding status. At 18 months corrected age (CA), infants will undergo neurodevelopmental follow-up testing, the results of which will be correlated with feeding outcomes in the neo-and post-natal period and with gene expression data and intervention status. Results: The ongoing National Institutes of Health funded randomized controlled trial R01HD086088 is actively recruiting participants. The expected completion date of the study is 2021. Conclusions: Differential salivary gene expression profiles in response to orosensory entrainment intervention are expected to lead to the development of individualized interventions for the diagnosis and management of oral feeding in preterm infants. Trial Registration: ClinicalTrials.gov NCT02696343; https://clinicaltrials.gov/ct2/show/NCT02696343 (Archived by WebCite at http://www.webcitation.org/6r5NbJ9Ym)

  • mISkin homescreen (montage). Source: The Authors / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/e112/; License: Creative Commons Attribution (CC-BY).

    Systematic and Iterative Development of a Smartphone App to Promote Sun-Protection Among Holidaymakers: Design of a Prototype and Results of Usability and...

    Abstract:

    Background: Sunburn and intermittent exposure to ultraviolet rays are risk factors for melanoma. Sunburn is a common experience during holidays, making tourism settings of particular interest for skin cancer prevention. Holidaymakers are a volatile populations found at different locations, which may make them difficult to reach. Given the widespread use of smartphones, evidence suggests that this might be a novel, convenient, scalable, and feasible way of reaching the target population. Objective: The main objective of this study was to describe and appraise the process of systematically developing a smartphone intervention (mISkin app) to promote sun-protection during holidays. Methods: The iterative development process of the mISkin app was conducted over four sequential stages: (1) identify evidence on the most effective behavior change techniques (BCTs) used (active ingredients) as well as theoretical predictors and theories, (2) evidence-based intervention design, (3) co-design with users of the mISkin app prototype, and (4) refinement of the app. Each stage provided key findings that were subsequently used to inform the design of the mISkin app. Results: The sequential approach to development integrates different strands of evidence to inform the design of an evidence-based intervention. A systematic review on previously tested interventions to promote sun-protection provided cues and constraints for the design of this intervention. The development and design of the mISkin app also incorporated other sources of information, such as other literature reviews and experts’ consultations. The developed prototype of the mISkin app was evaluated by engaging potential holidaymakers in the refinement and further development of the mISkin app through usability (ease-of-use) and acceptability testing of the intervention prototype. All 17 participants were satisfied with the mISkin prototype and expressed willingness to use it. Feedback on the app was integrated in the optimization process of the mISkin app. Conclusions: The mISkin app was designed to promote sun-protection among holidaymakers and was based on current evidence, experts’ knowledge and experience, and user involvement. Based on user feedback, the app has been refined and a fully functional version is ready for formal testing in a feasibility pilot study.

  • Source: The Authors / Gerd Altmann; Copyright: The Authors; URL: https://pixabay.com/en/hands-smartphone-barcodes-qr-1167612/; License: Creative Commons Attribution (CC-BY).

    Data Collection for Mental Health Studies Through Digital Platforms: Requirements and Design of a Prototype

    Abstract:

    Background: Mental and behavioral disorders are the main cause of disability worldwide. However, their diagnosis is challenging due to a lack of reliable biomarkers; current detection is based on structured clinical interviews which can be biased by the patient’s recall ability, affective state, changing in temporal frames, etc. While digital platforms have been introduced as a possible solution to this complex problem, there is little evidence on the extent of usability and usefulness of these platforms. Therefore, more studies where digital data is collected in larger scales are needed to collect scientific evidence on the capacities of these platforms. Most of the existing platforms for digital psychiatry studies are designed as monolithic systems for a certain type of study; publications from these studies focus on their results, rather than the design features of the data collection platform. Inevitably, more tools and platforms will emerge in the near future to fulfill the need for digital data collection for psychiatry. Currently little knowledge is available from existing digital platforms for future data collection platforms to build upon. Objective: The objective of this work was to identify the most important features for designing a digital platform for data collection for mental health studies, and to demonstrate a prototype platform that we built based on these design features. Methods: We worked closely in a multidisciplinary collaboration with psychiatrists, software developers, and data scientists and identified the key features which could guarantee short-term and long-term stability and usefulness of the platform from the designing stage to data collection and analysis of collected data. Results: The key design features that we identified were flexibility of access control, flexibility of data sources, and first-order privacy protection. We also designed the prototype platform Non-Intrusive Individual Monitoring Architecture (Niima), where we implemented these key design features. We described why each of these features are important for digital data collection for psychiatry, gave examples of projects where Niima was used or is going to be used in the future, and demonstrated how incorporating these design principles opens new possibilities for studies. Conclusions: The new methods of digital psychiatry are still immature and need further research. The design features we suggested are a first step to design platforms which can adapt to the upcoming requirements of digital psychiatry.

  • Shingles on the chest. Source: Wikimedia Commons; Copyright: Preston Hunt; URL: https://commons.wikimedia.org/wiki/File:Shingles_on_the_chest.jpg; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Pain Improvement With Novel Combination Analgesic Regimens (PAIN-CARE): Randomized Controlled Trial Protocol

    Abstract:

    Background: Neuropathic pain (NP) (including painful diabetic neuropathy, postherpetic neuralgia, etc) affects approximately 7% to 8% of the population and is associated with a devastating symptom burden as well as a profound economic impact for patients, their families, and the health care system. Current therapies have limited efficacy and dose-limiting adverse effects (AEs). Rational combination therapy with carefully selected NP drugs has shown potential for measurable improvements in pain relief, quality of life, and health care use. Today, over half of NP patients concurrently receive 2 or more analgesics but combination use is based on little evidence. Research is urgently needed to identify safer, more effective combinations. Objective: We hypothesize that analgesic combinations containing at least 1 nonsedating agent would be as safe but more effective than either monotherapy without increasing overall AEs because of additive pain relief. Pregabalin (PGB), a sedating anticonvulsant, is proven effective for NP; the antioxidant alpha-lipoic acid (ALA) is one of the only nonsedating systemic agents proven effective for NP. Thus, we will conduct a clinical trial to compare a PGB+ALA combination to each monotherapy for NP. Methods: Using a double-blind, double-dummy, crossover design, 54 adults with NP will be randomly allocated to 1 of 6 sequences of treatment with PGB, ALA and PGB+ALA combination. During each of 3 different treatment periods, participants will take 2 sets of capsules containing (1) ALA or placebo and (2) PGB or placebo for 31 days, followed by an 11-day taper/washout period. The primary outcome will be mean daily pain intensity (0-10) at maximally tolerated dose (MTD) during each period. Secondary outcomes, assessed at MTD, will include global improvement, adverse events, mood, and quality of life. Results: Participant recruitment is expected to begin September 1, 2017. The proposed trial was awarded external peer-reviewed funding by the Canadian Institutes of Health Research (Canada) on July 15, 2016. Conclusions: This trial will provide rigorous evidence comparing the efficacy of a PGB+ALA combination to PGB alone and ALA alone in the treatment of NP. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14577546; http://www.isrctn.com/ISRCTN14577546?q=&filters=conditionCategory:Signs%20and%20Symptoms,trialStatus: Ongoing,recruitmentCountry:Canada&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search (Archived by WebCite at http://www.webcitation.org/6qvHFDc6m)

  • The equipment used in this study. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/6/e106/; License: Creative Commons Attribution (CC-BY).

    Prevalence of and Risk Factors for Childhood Asthma, Rhinitis, and Eczema in Hong Kong: Proposal for a Cross-Sectional Survey

    Abstract:

    Background: Previous studies have shown that particulate matter is a major problem in indoor air quality in Hong Kong schools, but little has been done to assess its relationship with health indicators in the children attending those schools. Our study aims to address this research gap by collecting aerosol data in schools to examine the link between different air pollutants with childhood respiratory health. It is important to explore whether or not the prevalence of asthma, allergic rhinoconjunctivitis, and eczema are increasing in local children. Objective: Our aim is to (1) examine the prevalence of asthma, allergic rhinitis, and eczema in school children aged 6-7 years in Hong Kong between 2001 and 2017, and (2) measure air quality at primary schools and explore its relationship with health outcomes measured by the International Study of Asthma and Allergies in Childhood (ISAAC) survey. Methods: This is a cross-sectional study consisting of an ISAAC questionnaire and aerosol data collection. We have recruited over 2000 parents of primary school students aged 6-7 years old for the questionnaire, and so far 19 schools have completed aerosol data collection. Results: The study is expected to be completed this year. Conclusions: We predict that our study will show a significant change in the prevalence of asthma, allergic rhinitis, and eczema in school children aged 6-7 years old in recent years. In addition, we expect to show a significant association between air quality at school and health outcomes measured by the ISAAC survey.

  • MISSION logo. Source: Image created by the authors; Copyright: The authors; URL: http://www.health.org.uk/programmes/innovating-improvement/projects/mission-copd-modern-innovative-solutions-improving; License: Creative Commons Attribution (CC-BY).

    Modern Innovative Solutions in Improving Outcomes in Chronic Obstructive Pulmonary Disease (MISSION COPD): A Comparison of Clinical Outcomes Before and After...

    Abstract:

    Background: Chronic obstructive pulmonary disorder (COPD) affects over 1 million people in the United Kingdom, and 1 person dies from COPD every 20 minutes. The cost to people with COPD and the National Health Service is huge – more than 24 million working days lost a year and the annual expenditure on COPD is £810 million and £930 million a year. Objective: We aim to identify patients with COPD who are at risk of exacerbations and hospital admissions as well as those who have not been formally diagnosed, yet remain at risk. Methods: This mixed-methods study will use both data and interviews from patients and health care professionals. The project Modern Innovative SolutionS in Improving Outcomes iN COPD (MISSION COPD) will hold multidisciplinary carousel style clinics to rapidly assess the patients’ COPD and related comorbidities, and enhance patient knowledge and skills for self-management. Results: This study is ongoing. Conclusions: This research will capture quantitative and qualitative outcomes to accompany a program of quality improvement through delivery of novel care models.

  • Instructor can lead the mindfulness session in a virtual room with remote participants (montage). Source: The Authors / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/6/e108/; License: Creative Commons Attribution (CC-BY).

    A Cloud-Based Virtual Reality App for a Novel Telemindfulness Service: Rationale, Design and Feasibility Evaluation

    Abstract:

    Background: Worldwide, there has been a marked increase in stress and anxiety, also among patients with traumatic brain injury (TBI). Access to psychology services is limited, with some estimates suggesting that over 50% of sufferers are not accessing the existing services available to them for reasons such as inconvenience, embarrassment, or stigmatization concerns around mental health. Health service providers have increasingly been turning to drug-free therapies, such as mindfulness programs, as complementary treatments. Objective: Virtual reality (VR) as a new delivery method for meditation-based stress and anxiety reduction therapy offers configurable environments and privacy protection. Our objective was to design a serious learning-meditation environment and to test the feasibility of the developed telemindfulness approach based on cloud technologies. Methods: We developed a cloud-based system, which consisted of a Web interface for the mindfulness instructor and remote clients, who had 3D VR headsets. The mindfulness instructor could communicate over the Web interface with the participants using the headset. Additionally, the Web app enabled group sessions in virtual rooms, 360-degree videos, and real interactions or standalone meditation. The mindfulness program was designed as an 8-week Mindfulness-Based Stress Reduction course specifically for the developed virtual environments. The program was tested with four employees and four patients with TBI. The effects were measured with psychometric tests, the Mindful Attention Awareness Scale (MAAS) and the Satisfaction With Life Scale (SWLS). Patients also carried out the Mini-Mental State Examination (MMSE). An additional objective evaluation has also been carried out by tracking head motion. Additionally, the power spectrum analyses of similar tasks between sessions were tested. Results: The patients achieved a higher level of life satisfaction during the study (SWLS: mean 23.0, SD 1.8 vs mean 18.3, SD 3.9) and a slight increase of the MAAS score (mean 3.4, SD 0.6 vs mean 3.3, SD 0.4). Particular insight into the MAAS items revealed that one patient had a lower MAAS score (mean 2.3). Employees showed high MAAS scores (mean 4.3, SD 0.7) and although their SWLS dropped to mean 26, their SWLS was still high (mean 27.3, SD 2.8). The power spectrum showed that the employees had a considerable reduction in high-frequency movements less than 0.34 Hz, particularly with the 360-degree video. As expected, the patients demonstrated a gradual decrease of high-frequency movements while sitting during the mindfulness practices in the virtual environment. Conclusions: With such a small sample size, it is too early to make any specific conclusions, but the presented results may accelerate the use of innovative technologies and challenge new ideas in research and development in the field of mindfulness/telemindfulness.

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    Open Peer Review Period: Jun 19, 2017 - Jul 3, 2017

    Background: Surgical site infections (SSI) are among the most common hospital acquired infections. The incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts i...

    Background: Surgical site infections (SSI) are among the most common hospital acquired infections. The incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts in hospitals and healthcare systems around the world. However, SSI rates vary markedly within surgical categories and are poorly represented by routinely surveilled indicator procedures, e.g. mastectomy or hernia surgery. Therefore, relying on indicator procedures to estimate the burden of SSI is imprecise and introduces bias as hospitals may take special precautions to achieve lower SSI rates. The most common cause of SSI is Staphylococcus aureus, as recently confirmed by a Europe-wide point-prevalence study conducted by the ECDC. Objective: The primary objective is to determine the overall and the procedure specific incidence of S. aureus surgical SSI in Europe. As secondary objectives the overall and the procedure specific outcomes as well as the economic burden of S. aureus SSI in Europe will be evaluated. Explorative objectives are to characterize the composition of the surgical patient population and to estimate the number of patients at risk for S. aureus SSI. Methods: We will conduct a retrospective multinational, multicenter cohort study with a nested case-control part. The study includes all surgical procedures at a participating center in order to prevent selection bias and strengthen the understanding of SSI risk by determining incidence for all common surgical procedures. Data will be assessed in two populations: the cohort, including 150.000 adult patients who underwent any surgical procedure in 2016, and the case-control population; we will match patients establishing S. aureus SSI 1:1 with controls from the same center. Regarding the cohort, we will export data on demographics, surgery and microbiology from electronic files. More detailed data will be captured from the case-control population. The SALT study will include 16 major or academic surgical centers in Europe: five in France, four in Germany, two in Italy, three in Spain and two in the UK. Sites were selected using a feasibility questionnaire. Results: The overall and the procedure specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe will be determined. Furthermore, the composition of the surgical patient population in Europe will be characterized and the number of patients at risk for S. aureus SSI will be estimated. Conclusions: Results of the SALT study will help to better understand the precise risk of certain procedures. They will allow conclusions on the overall and the procedure specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe. Findings of the study may help designing clinical trials for S. aureus vaccines. Clinical Trial: The study is registered at www.clinicaltrials.gov.

  • A cross-sectional study on the influence of fear of pain and coping strategies on health-related quality of life and patient-anticipated outcomes in chronic pain patients: A study protocol.

    Date Submitted: Jun 14, 2017

    Open Peer Review Period: Jun 14, 2017 - Jun 28, 2017

    Background: Fear of pain and coping strategies, are emotional behavioural responses to pain. Both are known to play an important role in development and maintenance of pain. It is highly likely that f...

    Background: Fear of pain and coping strategies, are emotional behavioural responses to pain. Both are known to play an important role in development and maintenance of pain. It is highly likely that fear of pain and coping strategies influence each other, potentially affecting the course of chronic pain. To our knowledge, the relationship between pain, fear of pain and coping strategies and how they influence patient-anticipated outcomes and health-related quality of life has not been investigated. Objective: This study aims to test 2 hypotheses; (i) both fear of pain and coping strategies are sufficient causes for maintaining pain and (ii) fear of pain influences coping strategies and pain. The study will also examine the impact of fear of pain and coping strategies on health-related quality of life and patient-anticipated outcomes. Methods: The study will be conducted using a cross-sectional design - online survey. Three validated questionnaires; Fear of Pain questionnaire-III; Brief COPE questionnaire and EuroQoL-5d will be used to collect data. In addition, information pertaining to demographic factors, pain related factors and patient-anticipated outcomes will also be collected. The study has ethics approval from Human Research Ethics Committee, The University of Adelaide. The study participants will be individual’s aged 18 years and above who are experiencing pain for last 6 months. Effect measure modification technique will be used to examine if fear of pain acts as a moderator or mediator between coping strategies and pain. Simple and multinomial logistic regression analysis will be used to examine effect of fear of pain and coping strategies on health-related quality of life and patient-anticipated outcomes. Results: The findings from this study will help to extend our understanding on fear of pain and coping strategies; their interaction and their impact on health-related quality of life and patient-anticipated outcomes. Conclusions: This study findings may help health care professionals and researchers to tailor management strategies to suit individual patient framework.

  • High-yield HIV testing, facilitated linkage to care, and prevention for female youth in Kenya (GIRLS Study): An implementation science protocol for a priority population

    Date Submitted: Jun 13, 2017

    Open Peer Review Period: Jun 14, 2017 - Jun 28, 2017

    Background: Sub-Saharan Africa (SSA) is the region with the highest HIV burden. Adolescent girls and young women (AGYW) aged 15-24 years are twice as likely as their male peers to be infected, making...

    Background: Sub-Saharan Africa (SSA) is the region with the highest HIV burden. Adolescent girls and young women (AGYW) aged 15-24 years are twice as likely as their male peers to be infected, making females in SSA the most at risk group for HIV infection. Despite the need to increase knowledge of HIV status in this priority population, access, and uptake of testing remains low. High fertility, early coitarche, intergenerational sex and low likelihood of partner circumcision put many young women at increased risk. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for this vulnerable population. Objective: Using an implementation science framework, the purpose of this research protocol is to describe the innovative approaches we propose to optimize engagement of AGYW in both the HIV prevention and care continuum. Methods: We will evaluate prevention-treatment continuum interventions to increase uptake of HIV testing, linkage to and retention in care, and high-impact prevention among AGYW. We will rigorously compare two ‘seek’ recruitment strategies, three ‘test’ strategies including a self-testing option, and pilot adaptive ‘linkage’ to care interventions (SMART design), among at-risk AGYW aged 15-24 years in Homa Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to support identified high risk HIV-negative AGYW in reducing HIV risk and adhering to recommended HIV re-testing frequency. We will conduct cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention intervention. Results: Recruitment began the last week of May 2017, with anticipated 12 months of accrual and 12 months of follow-up. We expect to enroll 1,200 participants overall, with a random selection of 100 high risk HIV-negative AGYW for the prevention intervention (HIV-negative cohort) and approximately 108 HIV-positive AGYW for the SMART design pilot of adaptive linkage to care interventions (HIV-positive cohort). Conclusions: Lessons learned will inform best practices to increase adolescent girls and young women’s uptake of HIV prevention, testing, and linkage to care services in a high-HIV burden African setting. Clinical Trial: ClinicalTrials.gov identifier: NCT02735642 https://clinicaltrials.gov/ct2/show/NCT02735642

  • The effect of aging on physical performance among elderly craftsmen: A study protocol

    Date Submitted: Jun 13, 2017

    Open Peer Review Period: Jun 13, 2017 - Jun 27, 2017

    Background: In 2012, the Danish Parliament decided to increase retirement age. Unfortunately, craftsmen working in a physically demanding environment may be rendered unable to retain the ability to ad...

    Background: In 2012, the Danish Parliament decided to increase retirement age. Unfortunately, craftsmen working in a physically demanding environment may be rendered unable to retain the ability to adequately perform the physical requirements of their jobs, due to the age-related decrease in physical performance. Therefore, increasing the retirement age may not necessarily lead to the goal of keeping everybody in the labour market for a longer time. To date, our knowledge about the changes in physical performance of the elderly workforce is limited. In this cross-sectional study we seek to investigate the effects of aging on physical performance among elderly craftsmen. Methods: Approximately 100 Danish craftsmen between 50-70 years old will be recruited. The main measurement outcomes include (I) inflammatory status from blood samples, (II) body composition, (III) lung function, (IV) static and dynamic balance, (V) reaction time, precision, and movement variability during a hammering task, (VI) handgrip strength, rate of force development and force tracking, and (VII) estimated maximal rate of oxygen consumption. Additionally, information regarding working conditions, physical activity levels, and health status will be assessed with a questionnaire. Discussion: This study will increase the knowledge regarding changes in physical performance in the elderly workforce and may identify potential workplace hazards. Moreover, this study might shed light on the potentially problematic decision to increase retirement age for all.

  • Randomized controlled trial of balance training for fall reduction in individuals with COPD

    Date Submitted: Jun 9, 2017

    Open Peer Review Period: Jun 12, 2017 - Jun 26, 2017

    Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Although COPD treatment has traditionally focused on respiratory function, secondary e...

    Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Although COPD treatment has traditionally focused on respiratory function, secondary effects of the disease are increasingly recognized. A growing body of evidence shows that individuals with COPD have important deficits in balance control that may be associated with an increased risk of falls. Pulmonary rehabilitation (PR) is a key therapeutic intervention for individuals with COPD, however current international guidelines do not include balance training and fall prevention strategies. Objective: The primary aim of this trial is to determine the effects of PR with balance training compared to PR with no balance training on the 12-month rate of falls in patients with COPD. Secondary aims are to determine the effects of the intervention on balance, balance confidence and functional lower body strength, and to estimate the cost effectiveness of the program. Methods: A total of 400 individuals with COPD will be recruited to participate in an international multicenter randomized controlled trial. Individuals with COPD who have a self-reported decline in balance, a fall in the last two years or recent near fall will be randomly assigned to an intervention or control group. Participants will be recruited from nine PR centers across Canada, Europe and Australia. The intervention group will undergo tailored balance training in addition to PR and will receive a personalized home-based balance program. The control group will receive usual PR and a home program that does not include balance training. All participants will receive home visits by a physiotherapist at three, six and nine months to ensure proper technique and progression of home exercise programs as well as monthly phone calls to provide support and problem-solve any issues. The primary outcome will be incidence of falls at 12 months. Falls will be measured using a standardized definition and recorded using monthly self-report fall diary calendars. Participants will be asked to record falls and time spent performing their home exercise program on the fall diary calendars. Completed calendars will be returned to the research centers in pre-paid envelopes each month. Participants will be telephoned monthly to confirm the information, collect any missing data and gather healthcare utilization and loss of productivity data. Secondary measures collected by a blinded assessor at baseline (pre-PR), post-PR and 12 months will include clinical measures of balance, balance confidence, functional lower body strength and health status using the EQ-5D-5L. The cost effectiveness for the intervention group compared with the control group will be evaluated using the incremental cost per number of falls averted and the incremental cost per quality adjusted life years (QALY) gained. Results: Recruitment for the study began in January 2017 and is anticipated to be complete by December 2019. Results are expected to be available in 2020. Conclusions: Findings from this study will improve our understanding of the effectiveness and resource uses of tailored balance training for reducing falls in individuals with COPD. If effective, the intervention represents an opportunity to inform international guidelines and health policy for PR in individuals with COPD who are at risk of falling. Clinical Trial: NCT 02995681

  • User Participation and Engagement with the See Me Smoke-Free mHealth App: Results of a Prospective Feasibility Trial

    Date Submitted: Apr 21, 2017

    Open Peer Review Period: May 31, 2017 - Jul 14, 2017

    Background: The See Me Smoke-Free (SMSF) mobile health (mHealth) application (app) was developed to help women quit smoking by targeting concerns about body weight, body image, and self-efficacy throu...

    Background: The See Me Smoke-Free (SMSF) mobile health (mHealth) application (app) was developed to help women quit smoking by targeting concerns about body weight, body image, and self-efficacy through cognitive behavioral techniques and guided imagery audio files addressing smoking, diet, and physical activity. A feasibility trial found associations between SMSF usage and positive treatment outcomes. This paper reports a detailed exploration of program use among those who downloaded the app, and the relationship between program use and treatment outcomes. Objective: To determine whether: 1) participants were more likely to set quit dates, be current smokers, and report higher levels of smoking at baseline than non-participants; 2) participants opened the app and listened to audio files more frequently than non-participants; and 3) participants with more app usage had a higher likelihood of smoking abstinence at follow-up. Methods: The SMSF feasibility trial was a single arm, within-subjects, prospective cohort study with assessments at baseline, 30- and 90-days post-enrollment. The SMSF app was deployed on the Google Play store for download, and basic profile characteristics were obtained for all app installers. Additional variables were assessed for study participants. Participants were prompted to use the app daily during study participation. Crude differences in baseline characteristics between trial participants and non-participants were evaluated using t-tests (continuous variables) and Fisher’s exact tests (categorical variables). Exact Poisson tests were used to assess group-level differences in mean usage rates over the full study period, using aggregate Google Analytics data on participation and usage. Negative binomial regression models were used to estimate associations of app usage with participant baseline characteristics, after adjustment for putative confounders. Associations between app usage and smoking abstinence were assessed using separate logistic regression models for each outcome measure. Results: Participants (n=151) were more likely than non-participants (n=96) to report female gender (P < 0.02) and smoking in the 30 days prior to enrollment (P < 0.0001). Participants and non-participants opened the app and updated quit dates at the same average rate (Rate ratio (RR) 0.98; 95% CI: 0.92, 1.04; P = 0.43), but participants started audio files (RR 1.07; 95% CI: 1.00, 1.13; P < 0.04) and completed audio files (RR 1.11; 95% CI: 1.03, 1.18; P < 0.003) at significantly higher rates than non-participants. Higher app usage among participants was generally associated with increased smoking cessation, and most effect sizes suggested strong associations, though generally without statistical significance. Conclusions: The current study suggests potential efficacy of the SMSF app, as increased usage was generally associated with higher smoking abstinence. A planned randomized controlled trial will assess the SMSF app’s efficacy as an intervention tool to help women quit smoking. Clinical Trial: ClinicalTrials.gov NCT02972515

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