Alene Toulany, Dmitry Khodyakov, Sarah Mooney, Lisa Stromquist, Katherine Bailey, Claire E H Barber, Michelle Batthish, Kristin Cleverley, Gina Dimitropoulos, Jan Willem Gorter, Danijela Grahovac, Ruth Grimes, Beverly Guttman, Michèle L Hébert, Tomisin John, Lisha Lo, Dorothy Luong, Laura MacGreogor, Geetha Mukerji, Jacklynn Pidduck, Vjura Senthilnathan, Rayzel Shulman, Patricia Trbovich, Sarah E P Munce
BACKGROUND: The transition from paediatric to adult care poses a significant health system-level challenge impeding the delivery of quality health services for youth with chronic health conditions. In Canada and globally, the transition to adult care is regarded as a top priority in adolescent health in need of readily applicable, adaptable, and relevant national metrics to evaluate and benchmark transition success across disease populations and clinical care settings. Unfortunately, existing literature fails to account for the lack of engagement from youth and caregivers in developing indicators, and its applicability across chronic conditions, primary care involvement, and health equity considerations...
June 18, 2024: JMIR Research Protocols
Srinalesti Mahanani, Nyoman Kertia, Ema Madyaningrum
BACKGROUND: Curcuminoids and acupressure have beneficial effects in reducing pain and inflammation in patients with Osteoarthritis. However, only a few clinical trials are investigating biomarkers to prove this objectively. OBJECTIVE: This study aimed to investigate the efficacy of acupressure and curcuminoids to inflammatory markers and pain in elderly with Osteoarthritis Genu. METHODS: Randomized controlled trial (RCT) was conducted among elderly with Osteoarthritis...
May 14, 2024: JMIR Research Protocols
Steffen Flindt Nielsen, Camilla Lundgreen Duus, Niels Henrik Buus, Jesper Nørgaard Bech, Frank Holden Mose
BACKGROUND: Sodium-Glucose-Cotransporter 2 inhibitors (SGLT2i) have revolutionized treatment of type 2 diabetes mellitus (DM2) and chronic kidney disease (CKD), reducing risk of cardiovascular and renal endpoints by up to 40%. The underlying mechanisms are not fully understood. OBJECTIVE: To examine the effects of empagliflozin versus placebo on renal hemodynamics, sodium balance, vascular function, and markers of the innate immune system in patients with DM2, DM2 and CKD and non-diabetic CKD...
April 25, 2024: JMIR Research Protocols
Maryam Mallakin, Joe Langley, Gillian Harvey, Sarah Walker, Caylee Raber, Nadia Beyzaei, Luz A Paczka Giorgi, Paul Holyoke, Kate Sellen
BACKGROUND: The COVID-19 pandemic significantly transformed the landscape of work and collaboration, impacting design research methodologies and techniques. Co-design approaches have been both negatively and positively affected by the pandemic, prompting a need to investigate and understand the extent of these impacts, changes, and adaptations, specifically in the health sector. Despite the challenges that the pandemic imposed on conducting co-design and related projects, it also encouraged a re-evaluation of co-design practices, leading to innovative solutions and techniques...
July 17, 2024: JMIR Research Protocols
Xin Hui Chua, Sarah Martine Edney, Andre Matthias Müller, Nicholas A Petrunoff, Clare Whitton, Zoey Tay, Claire Marie Jie Lin Goh, Bozhi Chen, Su Hyun Park, Salome A Rebello, Alicia Low, Janelle Chia, Daphne Koek, Karen Cheong, Rob M van Dam, Falk Müller-Riemenschneider
BACKGROUND: Integration of mobile health data collection methods into cohort studies enables the collection of intensive longitudinal information, which gives deeper insights into individuals' health and lifestyle behavioral patterns over time, as compared to traditional cohort methods with less frequent data collection. These findings can then fill the gaps that remain in understanding how various lifestyle behaviors interact as students graduate from university and seek employment (student-to-work life transition), where the inability to adapt quickly to a changing environment greatly affects the mental well-being of young adults...
July 17, 2024: JMIR Research Protocols
Mei Yi Ng, Jennifer A Frederick, Aaron J Fisher, Nicholas B Allen, Jeremy W Pettit, Dana L McMakin
BACKGROUND: Adolescence is marked by an increasing risk of depression and is an optimal window for prevention and early intervention. Personalizing interventions may be one way to maximize therapeutic benefit, especially given the marked heterogeneity in depressive presentations. However, empirical evidence that can guide personalized intervention for youth is lacking. Identifying person-specific symptom drivers during adolescence could improve outcomes by accounting for both developmental and individual differences...
July 16, 2024: JMIR Research Protocols
Jay J Park, Jakov Tiefenbach, Mohammed Ma'arij Anwar, Sandhya Narayanan, Beatrice Ope, Selene Seo Bin Han, Boni Maxime Ale, Davies Adeloye, Igor Rudan
BACKGROUND: Streptococcus pneumoniae (Spn) has been a leading cause of bacterial meningitis in children. The most recent estimation of the global burden of Spn meningitis indicates a positive trajectory in eliminating Spn through the implementation of pneumococcal conjugate vaccines. However, continuous monitoring and assessment of the disease burden are necessary due to the evidence of serotype replacement, antibiotic resistance, and the impact of the recent COVID-19 pandemic. OBJECTIVE: The aim of this systematic review is to provide an updated and focused assessment of the global and regional burden of Spn meningitis in children, which can guide policies and strategies to reduce the disease burden...
July 16, 2024: JMIR Research Protocols
Swasti Deshpande, Ashmeet Sachdev, Anwesha Maharana, Siddhesh Zadey, Surabhi P Dharmadhikari, Swati Ghate, Pawankumar Godatwar, Nisha Kumari Ojha, Sanjeev Sharma
BACKGROUND: Screen use time has increased in the past decade owing to the increased availability and accessibility of digital devices and the internet. Several studies have shown an association between increased screen use time and mental health issues such as anxiety and depression. However, studies in the young adult population-a demographic with high screen use-and in low- and middle-income country settings are limited. OBJECTIVE: This protocol describes a study that aims to measure self-reported screen use times and patterns in young adults (18-24 y) in India and assess if increased screen use time is associated with poorer mental well-being...
July 16, 2024: JMIR Research Protocols
Takumu Kurosawa, Koichiro Adachi, Ryu Takizawa
BACKGROUND: Mental health problems among workers cause enormous losses to companies in Japan. However, workers have been considered to have limited access to psychological support because of time constraints, which makes it difficult for them to engage in face-to-face psychological support interventions. OBJECTIVE: This study aimed to present an intervention protocol that describes a randomized controlled trial to examine whether brief guided mindfulness meditation (MM) or self-compassion meditation (SCM) provided by a smartphone app is effective for mental health and work-related outcomes among workers...
July 15, 2024: JMIR Research Protocols
Sarah J Myers, Rebecca L Knight, Sophie L Wardle, Kirsty Am Waldock, Thomas J O'Leary, Richard K Jones, Paul E Muckelt, Anton Eisenhauer, Jonathan Cy Tang, William D Fraser, Julie P Greeves
BACKGROUND: Women of reproductive age experience cyclical variation in the female sex steroid hormones 17β-estradiol and progesterone during the menstrual cycle that is attenuated by some hormonal contraceptives. Estrogens perform a primary function in sexual development and reproduction but have nonreproductive effects on bone, muscle, and sinew tissues (ie, ligaments and tendons), which may influence injury risk and physical performance. OBJECTIVE: The purpose of the study is to understand the effect of the menstrual cycle and hormonal contraceptive use on bone and calcium metabolism, and musculoskeletal health and performance...
July 11, 2024: JMIR Research Protocols
Aditya U Kale, Riya Dattani, Ashley Tabansi, Henry David Jeffry Hogg, Russell Pearson, Ben Glocker, Su Golder, Justin Waring, Xiaoxuan Liu, David J Moore, Alastair K Denniston
BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias)...
July 11, 2024: JMIR Research Protocols
Kumi Watanabe Miura, Takashi Kudo, Mihoko Otake-Matsuura
BACKGROUND: Social communication is a key factor in maintaining cognitive function and contributes to well-being in later life. OBJECTIVE: This study will examine the effects of "Photo-Integrated Conversation Moderated by Application version 2" (PICMOA-2), which is a web-based conversational intervention, on cognitive performance, frailty, and social and psychological indicators among community-dwelling older adults. METHODS: This study is a randomized controlled trial with an open-label, 2-parallel group trial and 1:1 allocation design...
July 11, 2024: JMIR Research Protocols
Jie Xu, Sankalp Talankar, Jinqian Pan, Ira Harmon, Yonghui Wu, David A Fedele, Jennifer Brailsford, Jennifer Noel Fishe
BACKGROUND: Pediatric asthma is a heterogeneous disease; however, current characterizations of its subtypes are limited. Machine learning (ML) methods are well-suited for identifying subtypes. In particular, deep neural networks can learn patient representations by leveraging longitudinal information captured in electronic health records (EHRs) while considering future outcomes. However, the traditional approach for subtype analysis requires large amounts of EHR data, which may contain protected health information causing potential concerns regarding patient privacy...
July 8, 2024: JMIR Research Protocols
Mark A Ferro, Christy K Y Chan, Dillon T Browne, Ian Colman, Joel A Dubin, Laura Duncan
BACKGROUND: Evidence suggests that having a chronic physical illness (CPI; eg, asthma, diabetes, and epilepsy) is an independent risk factor for suicidality (ie, suicidal ideation or attempts) among youth. Less is known about the mechanisms linking CPI and suicidality. Some evidence suggests that mental illness (eg, depression and anxiety) or neurodevelopmental disorder (eg, attention-deficit/hyperactivity disorder) mediates or moderates the CPI-suicidality association. Missing from the knowledge base is information on the association between having co-occurring CPI and mental illness or neurodevelopmental disorder (MIND) on youth suicidality...
July 4, 2024: JMIR Research Protocols
María Del Mar Garcia-Calvente, Diana Juanita Mora, María Del Río-Lozano
BACKGROUND: The aging population and increased disability prevalence in Spain have heightened the demand for long-term care. Informal caregiving, primarily performed by women, plays a crucial role in this scenario. This protocol outlines the CUIDAR-SE study, focusing on the gender-specific impact of informal caregiving on health and quality of life among caregivers in Andalusia and the Basque Country from 2013 to 2024. OBJECTIVE: This study aims to analyze the gender differences in health and quality of life indicators of informal caregivers residing in 2 Spanish autonomous communities (Granada, Andalusia, and Gipuzkoa; Basque Country) and their evolution over time, in relation to the characteristics of caregivers, the caregiving situation, and support received...
July 2, 2024: JMIR Research Protocols
Michele Polfuss, Kathryn Smith, Betsy Hopson, Andrea Moosreiner, Chiang-Ching Huang, Michele N Ravelli, Dan Ding, Zijian Huang, Brandon G Rocque, Rosemary White-Traut, Alexander Van Speybroeck, Kathleen J Sawin
BACKGROUND: Obesity prevalence in youth with spina bifida is higher than in their typically developing peers. Obesity is associated with lifelong medical, psychological, and economic burdens. Successful prevention or treatment of obesity in individuals with spina bifida is compromised by (1) the lack of valid and reliable methods to identify body fat in a clinical setting and (2) limited data on energy expenditure that are necessary to provide daily caloric recommendations. OBJECTIVE: The objectives of this study will be to develop 2 algorithms for use in youth with spina bifida in a clinical setting, one to model body fat and one to predict total daily energy expenditure...
July 2, 2024: JMIR Research Protocols
Phyu Sin Aye, Joanne Barnes, George Laking, Laird Cameron, Malcolm Anderson, Brendan Luey, Stephen Delany, Dean Harris, Blair McLaren, Elliott Brenman, Jayden Wong, Ross Lawrenson, Michael Arendse, Sandar Tin Tin, Mark Elwood, Philip Hope, Mark James McKeage
BACKGROUND: Starting in 2010, the epidermal growth factor receptor (EGFR) kinase inhibitors erlotinib and gefitinib were introduced into routine use in Aotearoa New Zealand (NZ) for treating advanced lung cancer, but their impact in this setting is unknown. OBJECTIVE: The study described in this protocol aims to understand the effectiveness and safety of these new personalized lung cancer treatments and the contributions made by concomitant medicines and other factors to adverse outcomes in the general NZ patient population...
July 2, 2024: JMIR Research Protocols
Dumitru Emanuel Dogaru, Serban Rosu, Dionisio Franco Barattini, Simone Guadagna, Luca Barattini, Bogdan Andor
BACKGROUND: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid...
June 28, 2024: JMIR Research Protocols
Amber J Hackstadt, Tom A Elasy, Sapna Gangaputra, Kryseana J Harper, Lindsay S Mayberry, Lyndsay A Nelson, Neeraja B Peterson, S Trent Rosenbloom, Zhihong Yu, William Martinez
BACKGROUND: Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months). OBJECTIVE: This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes...
June 28, 2024: JMIR Research Protocols
Aditya U Kale, Henry David Jeffry Hogg, Russell Pearson, Ben Glocker, Su Golder, April Coombe, Justin Waring, Xiaoxuan Liu, David J Moore, Alastair K Denniston
BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm...
June 28, 2024: JMIR Research Protocols
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