JMIR research protocols
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JMIR research protocols · Apr 2021
A Live Video Program to Prevent Chronic Pain and Disability in At-Risk Adults With Acute Orthopedic Injuries (Toolkit for Optimal Recovery): Protocol for a Multisite Feasibility Study.
Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial. ⋯ PRR1-10.2196/28155.
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JMIR research protocols · Apr 2021
Digital Epidemiologic Research on Multilevel Risks for HIV Acquisition and Other Health Outcomes Among Transgender Women in Eastern and Southern United States: Protocol for an Online Cohort.
The HIV epidemic disproportionately impacts transgender women in the United States. Cohort studies identify unique risks for affected populations, but use of facility-based methods may bias findings towards individuals living in research catchment areas, more engaged in health services, or, in the case of transgender populations, those who are open about their transgender identity. Digital clinical trials and other online research methods are increasingly common, providing opportunity to reach those not commonly engaged in research. Simultaneously, there is a need to understand potential biases associated with digital research, how these methods perform, and whether they are accepted across populations. ⋯ DERR1-10.2196/29152.
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JMIR research protocols · Apr 2021
Nutritional Implications of Baby-Led Weaning and Baby Food Pouches as Novel Methods of Infant Feeding: Protocol for an Observational Study.
The complementary feeding period is a time of unparalleled dietary change for every human, during which the diet changes from one that is 100% milk to one that resembles the usual diet of the wider family in less than a year. Despite this major dietary shift, we know relatively little about food and nutrient intake in infants worldwide and virtually nothing about the impact of baby food "pouches" and "baby-led weaning" (BLW), which are infant feeding approaches that are becoming increasingly popular. Pouches are squeezable containers with a plastic spout that have great appeal for parents, as evidenced by their extraordinary market share worldwide. BLW is an alternative approach to introducing solids that promotes infant self-feeding of whole foods rather than being fed purées, and is popular and widely advocated on social media. The nutritional and health impacts of these novel methods of infant feeding have not yet been determined. ⋯ This large study will provide much needed data on the implications for nutritional intake and health with the use of baby food pouches and BLW in infancy.
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JMIR research protocols · Apr 2021
Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection (PROUDEST Trial): Protocol for a Multicenter, Prospective Cohort Study.
A growing body of evidence suggests that SARS-COV-2 infection during pregnancy may affect maternal-fetal outcomes and possibly result in implications for the long-term development of SARS-CoV-2-exposed children. ⋯ Upon completion of the study, we expect to have comprehensive data that will provide a better understanding of the effects of SARS-CoV-2 infection and related inflammatory and immunological processes on pregnancy, puerperium, and infancy. Our findings will inform clinical decisions regarding the care of SARS-CoV-2-exposed mothers and children and support the development of evidence-based public health policies.
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JMIR research protocols · Apr 2021
Electronic Health Record-Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study.
Individuals living with sickle cell disease often require aggressive treatment of pain associated with vaso-occlusive episodes in the emergency department. Frequently, pain relief is poor. The 2014 National Heart, Lung, and Blood Institute evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of vaso-occlusive episodes. ⋯ This study proposes a structured, framework-informed approach to implement electronic health record-embedded individualized pain plans with both patient and provider access in routine emergency department practice. The results of the study will inform the implementation of electronic health record-embedded individualized pain plans at a larger scale outside of Sickle Cell Disease Implementation Consortium centers.