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JMIR Research Protocols

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https://www.readbyqxmd.com/read/28923789/assessing-the-efficacy-and-safety-of-an-11%C3%AE-hydroxysteroid-dehydrogenase-type-1-inhibitor-azd4017-in-the-idiopathic-intracranial-hypertension-drug-trial-iih-dt-clinical-methods-and-design-for-a-phase-ii-randomized-controlled-trial
#1
Keira Annie Markey, Ryan Ottridge, James L Mitchell, Caroline Rick, Rebecca Woolley, Natalie Ives, Peter Nightingale, Alexandra J Sinclair
BACKGROUND: Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. OBJECTIVES: The purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the rationale for the chosen trial methodology. METHODS: IIH:DT is a phase II double-blind randomized placebo-controlled trial recruiting 30 female participants with active IIH (intracranial pressure >25cm H2 O and papilledema)...
September 18, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28912114/understanding-the-natural-progression-of-spina-bifida-prospective-study
#2
Judy Thibadeau, Matthew R Reeder, Jennifer Andrews, Katherine Ong, Marcia L Feldkamp, Sydney Rice, Ann Alriksson-Schmidt
BACKGROUND: Spina bifida (SB) is monitored through birth defects surveillance across the United States and in most developed countries. Although much is known about the management of SB and its many comorbid conditions in affected individuals, there are few systematic, longitudinal studies on population-based cohorts of children or adults. The natural history of SB across the life course of persons with this condition is not well documented. Earlier identification of comorbidities and secondary conditions could allow for earlier intervention that might enhance the developmental trajectory for children with SB...
September 14, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28903891/health-information-national-trends-survey-in-american-sign-language-hints-asl-protocol-for-the-cultural-adaptation-and-linguistic-validation-of-a-national-survey
#3
Poorna Kushalnagar, Raychelle Harris, Raylene Paludneviciene, TraciAnn Hoglind
BACKGROUND: The Health Information National Trends Survey (HINTS) collects nationally representative data about the American's public use of health-related information. This survey is available in English and Spanish, but not in American Sign Language (ASL). Thus, the exclusion of ASL users from these national health information survey studies has led to a significant gap in knowledge of Internet usage for health information access in this underserved and understudied population. OBJECTIVE: The objectives of this study are (1) to culturally adapt and linguistically translate the HINTS items to ASL (HINTS-ASL); and (2) to gather information about deaf people's health information seeking behaviors across technology-mediated platforms...
September 13, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28899848/a-multi-level-mobile-enabled-intervention-to-promote-physical-activity-in-older-adults-in-the-primary-care-setting-icanfit-2-0-protocol-for-a-cluster-randomized-controlled-trial
#4
Y Alicia Hong, Samuel N Forjuoh, Marcia G Ory, Michael D Reis, Huiyan Sang
BACKGROUND: Most older adults do not adhere to the US Centers for Disease Control physical activity guidelines; their physical inactivity contributes to overweight and multiple chronic conditions. An urgent need exists for effective physical activity-promotion programs for the large number of older adults in the United States. OBJECTIVE: This study presents the development of the intervention and trial protocol of iCanFit 2.0, a multi-level, mobile-enabled, physical activity-promotion program developed for overweight older adults in primary care settings...
September 12, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28893727/development-of-a-virtual-reality-exposure-tool-as-psychological-preparation-for-elective-pediatric-day-care-surgery-methodological-approach-for-a-randomized-controlled-trial
#5
Robin Eijlers, Jeroen S Legerstee, Bram Dierckx, Lonneke M Staals, Johan Berghmans, Marc P van der Schroeff, Rene Mh Wijnen, Elisabeth Mwj Utens
BACKGROUND: Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. OBJECTIVE: The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU)...
September 11, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28887293/influence-of-fear-of-pain-and-coping-strategies-on-health-related-quality-of-life-and-patient-anticipated-outcomes-in-patients-with-chronic-pain-cross-sectional-study-protocol
#6
Manasi Murthy Mittinty, David S Brennan, Cameron L Randall, Daniel W McNeil, Murthy N Mittinty, Lisa Jamieson
BACKGROUND: Fear of pain and coping strategies are emotional-behavioral responses to pain and are known to play an important role in the 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, have not been investigated...
September 8, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28887292/protocol-for-usability-testing-and-validation-of-the-iso-draft-international-standard-19223-for-lung-ventilators
#7
Dev Minotra, Steven L Dain, Catherine M Burns
BACKGROUND: Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues...
September 8, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28882811/effect-of-caffeine-on-attention-and-alertness-measured-in-a-home-setting-using-web-based-cognition-tests
#8
Wilrike J Pasman, Ruud Boessen, Yoni Donner, Nard Clabbers, André Boorsma
BACKGROUND: There is an increasing interest among nutritional researchers to perform lifestyle and nutritional intervention studies in a home setting instead of testing subjects in a clinical unit. The term used in other disciplines is 'ecological validity' stressing a realistic situation. This becomes more and more feasible because devices and self-tests that enable such studies are more commonly available. Here, we present such a study in which we reproduced the effect of caffeine on attention and alertness in an at-home setting...
September 7, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28882810/study-of-methods-for-assessing-research-topic-elicitation-and-prioritization-smarter-study-protocol-to-compare-qualitative-research-methods-and-advance-patient-engagement-in-research
#9
Danielle C Lavallee, Bryan Comstock, Mary R Scott, Andrew L Avins, David R Nerenz, Todd C Edwards, Donald L Patrick, Sarah O Lawrence, Zoya Bauer, Anjali R Truitt, Jeffrey G Jarvik
BACKGROUND: Involving patients as partners in research is a defining characteristic of patient-centered outcomes research (PCOR). While patients' experiential knowledge of a health condition or treatment may yield research priorities not reflected by researchers and policy makers, the methods for identifying and effectively collaborating with patients are still evolving. Patient registries and crowdsourcing may offer ease of access and convenience to both researchers and patients. Surveys and focus groups, including online modalities, have been described for prioritizing research topics...
September 7, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28877863/the-paget-trial-a-multicenter-observational-cohort-intervention-study-for-the-clinical-efficacy-safety-and-immunological-response-of-topical-5-imiquimod-cream-for-vulvar-paget-disease
#10
Michelle van der Linden, Kim Meeuwis, Colette van Hees, Eleonora van Dorst, Johan Bulten, Tjalling Bosse, Joanna IntHout, Dorry Boll, Brigitte Slangen, Manon van Seters, Marc van Beurden, Mariëtte van Poelgeest, Joanne de Hullu
BACKGROUND: Vulvar Paget disease is a rare skin disorder, which is most common in postmenopausal Caucasian women. They usually present with an erythematous plaque that may show fine or typical "cake icing" scaling or ulceration that may cause itching, pain, irritation, or a burning sensation. Although most cases are noninvasive, vulvar Paget disease may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The histological evidence of so-called "Paget cells" with abundant pale cytoplasm in the epithelium confirms the diagnosis...
September 6, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28864428/legacy-effect-of-delayed-blood-pressure-lowering-pharmacotherapy-in-middle-aged-individuals-stratified-by-absolute-cardiovascular-disease-risk-protocol-for-a-systematic-review
#11
Chau Le Bao Ho, Sharon Sanders, Jenny Doust, Monique Breslin, Christopher M Reid, Mark Raymond Nelson
BACKGROUND: Many national and international guidelines recommend that the initiation of blood pressure (BP)-lowering drug treatment for the primary prevention of cardiovascular disease (CVD) should no longer be based on BP level alone, but on absolute cardiovascular risk. While BP-lowering drug treatment is beneficial in high-risk individuals at any level of elevated BP, clinicians are concerned about legacy effects on patients with low-to-moderate risk and mildly elevated BP who remain "untreated"...
September 1, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28860107/project-stronger-together-protocol-to-test-a-dyadic-intervention-to-improve-engagement-in-hiv-care-among-sero-discordant-male-couples-in-three-us-cities
#12
Rob Stephenson, Nicolas A Suarez, Robert Garofalo, Marco A Hidalgo, Samuel Hoehnle, Jennie Thai, Matthew J Mimiaga, Emily Brown, Anna Bratcher, Taylor Wimbly, Patrick Sullivan
BACKGROUND: An estimated one- to-two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this fact, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk, and to support each other towards active engagement in HIV prevention and care, are urgently needed. OBJECTIVE: The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples' HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States...
August 31, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28860105/ascertaining-the-value-of-noninvasive-measures-obtained-using-color-duplex-ultrasound-and-central-aortic-pressure-monitoring-during-the-management-of-cerebral-arteriovenous-malformation-resection-protocol-for-a-prospective-case-control-pilot-study
#13
Kathryn J Busch, Hosen Kiat
BACKGROUND: Dramatic hemodynamic changes occur upon removal of an arteriovenous malformation of the brain (bAVM) with a number of potentially serious perioperative complications, such as intracranial hemorrhage and venous occlusive hypertensive syndrome. As these complications largely occur in the postoperative inpatient period, a rapid, repeatable noninvasive investigation to serially monitor relevant intracranial hemodynamics may be of benefit. Though, transcranial Doppler (TCD) and transcranial color duplex (TCCD) are techniques used and available to provide hemodynamic measurements postoperatively, the time course of hemodynamic sequences following bAVM resection remains uncertain...
August 31, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28855148/ivermectin-treatment-in-patients-with-onchocerciasis-associated-epilepsy-protocol-of-a-randomized-clinical-trial
#14
Robert Colebunders, Michel Mandro, Deby Mukendi, Housseini Dolo, Patrick Suykerbuyk, Marieke Van Oijen
BACKGROUND: Many studies have reported an association between epilepsy, nodding syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass ivermectin distribution. There is evidence that increasing the coverage of ivermectin reduces the incidence of epilepsy, and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis-associated epilepsy (OAE) patients who receive ivermectin...
August 30, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28851678/automating-construction-of-machine-learning-models-with-clinical-big-data-proposal-rationale-and-methods
#15
Gang Luo, Bryan L Stone, Michael D Johnson, Peter Tarczy-Hornoch, Adam B Wilcox, Sean D Mooney, Xiaoming Sheng, Peter J Haug, Flory L Nkoy
BACKGROUND: To improve health outcomes and cut health care costs, we often need to conduct prediction/classification using large clinical datasets (aka, clinical big data), for example, to identify high-risk patients for preventive interventions. Machine learning has been proposed as a key technology for doing this. Machine learning has won most data science competitions and could support many clinical activities, yet only 15% of hospitals use it for even limited purposes. Despite familiarity with data, health care researchers often lack machine learning expertise to directly use clinical big data, creating a hurdle in realizing value from their data...
August 29, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28851676/engaging-adolescents-to-inform-the-development-of-a-mobile-gaming-app-to-incentivize-physical-activity
#16
Lizzy Pope, Bernice Garnett, Marguerite Dibble
BACKGROUND: Involving youth in the development of a mobile game designed to increase physical activity may increase relevancy and adoption. OBJECTIVE: To share the development process used to create a gaming app aimed at incentivizing physical activity in high school students. METHODS: Five focus groups were conducted with high school students (N=50) to understand gaming behaviors. A subset of students from the focus groups chose to complete a Web-based survey (N=10)...
August 29, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28838886/smartphone-enabled-health-coaching-intervention-imove-to-promote-long-term-maintenance-of-physical-activity-in-breast-cancer-survivors-protocol-for-a-feasibility-pilot-randomized-controlled-trial
#17
Paul Ritvo, Maya Obadia, Daniel Santa Mina, Shabbir Alibhai, Catherine Sabiston, Paul Oh, Kristin Campbell, David McCready, Leslie Auger, Jennifer Michelle Jones
BACKGROUND: Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors...
August 24, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28838884/conventional-cognitive-behavioral-therapy-facilitated-by-an-internet-based-support-system-feasibility-study-at-a-psychiatric-outpatient-clinic
#18
Kristoffer Nt Månsson, Hugo Klintmalm, Ragnar Nordqvist, Gerhard Andersson
BACKGROUND: Cognitive behavioral therapies have been shown to be effective for a variety of psychiatric and somatic disorders, but some obstacles can be noted in regular psychiatric care; for example, low adherence to treatment protocols may undermine effects. Treatments delivered via the Internet have shown promising results, and it is an open question if the blend of Internet-delivered and conventional face-to-face cognitive behavioral therapies may help to overcome some of the barriers of evidence-based treatments in psychiatric care...
August 24, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28835355/efficacy-of-lactobacillus-reuteri-dsm-17938-for-the-treatment-of-acute-gastroenteritis-in-children-protocol-of-a-randomized-controlled-trial
#19
Henryk Szymański, Hania Szajewska
BACKGROUND: Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. However, despite proven efficacy, it remains underused. This is because oral rehydration solution neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness. Hence, there is interest in adjunctive treatments. According to the 2014 guidelines developed by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, the use of the following probiotics may be considered in the management of children with AGE in addition to rehydration therapy: Lactobacillus rhamnosus GG (low quality of evidence; strong recommendation) and Saccharomyces boulardii (low quality of evidence; strong recommendation)...
August 23, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28830854/a-mobile-device-app-to-reduce-medication-errors-and-time-to-drug-delivery-during-pediatric-cardiopulmonary-resuscitation-study-protocol-of-a-multicenter-randomized-controlled-crossover-trial
#20
Johan N Siebert, Frederic Ehrler, Christian Lovis, Christophe Combescure, Kevin Haddad, Alain Gervaix, Sergio Manzano
BACKGROUND: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion...
August 22, 2017: JMIR Research Protocols
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