Engaging trauma survivors/caregivers results in research findings that are more relevant to patients' needs and priorities. Although their perspectives increase research significance, there is a lack of understanding about how best to incorporate their insights. We aimed to capture stakeholder perspectives to ensure research is meaningful, respectful, and relevant to the injured patient and their caregivers.
Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
Basic Physical Pharmacy provides a thorough yet accessible overview of the principles of physical pharmacy and their application in drug formulation and administration. This definitive guide to physical pharmacy covers all types of pharmaceuticals, from traditional forms and dosages to nanotechnology-based novel dosage design. Authored by two nationally recognized pharmaceutical scientists and active pharmacy faculty, Basic Physical Pharmacy is clearly organized into four sections: Physical Pharmacy in Solutions; Solid Dosage Forms; Polyphasic Systems; and Drug Delivery and Novel Drug Delivery Systems. Students can build upon their chemistry education to learn the physicochemical properties of drugs and their therapeutic effects on the body. With a highly accessible approach, Basic Physical Pharmacy will help students comprehend and apply the principles of physical pharmacy in clinical practice. Covers major drug products and delivery systems Features current trends in pharmaceutical research and development, including nanotechnology-based dosage design Includes many examples of useful equations and formulation methods Contains over 200 illustrations, photos, and tables Topics Include: Solutions Ionization of Drugs in Solutions Buffers and Buffered Solutions Drug Solubility Diffusion and Dissolution Distribution Phenomena Complexation and Protein Binding Interfacial Phenomena Rheology Colloids Suspensions and Emulsions Semisolid Dosage Forms Dermatologicals Suppositories Powders Capsules Tablets Aerosols Sterile Dosage Forms Ophthalmic Formulations Radiopharmaceuticals Modified Release Drug Delivery Systems Biotechnology Products Drug Product Stability Each new print textbook includes an access code for the online Companion Website. Ebooks do not include access to the Companion Website. Access to the Companion Website may also be purchased separately under the RESOURCES tab, FOR STUDENTS. Student Companion Website includes: Cross Words, Flash Cards, Interactive Glossary, Matching Questions Instructor Resources Answers to End of Chapter Questions Image Bank Power Point Presentations Test Bank Topics Include: Solutions Ionization of Drugs in Solutions Buffers and Buffered Solutions Drug Solubility Diffusion and Dissolution Distribution Phenomena Complexation and Protein Binding Interfacial Phenomena Rheology Colloids Suspensions and Emulsions Semisolid Dosage Forms Dermatologicals Suppositories Powders Capsules Tablets Aerosols Sterile Dosage Forms Ophthalmic Formulations Radiopharmaceuticals Modified Release Drug Delivery Systems Biotechnology Products Drug Product Stability Each new print textbook includes an access code for online student resources. Ebooks do not include access to the Companion Website. Access to the Companion Website may also be purchased separately. Student Companion Website includes: Cross Words, Flash Cards, Interactive Glossary, Matching Questions Instructor Resources: Answers to End of Chapter Questions Image Bank Power Point Presentations Test Bank
Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.
INTRODUCTION: Postpartum hemorrhage is one of the leading causes of maternal deaths worldwide. Attempts to remedy this problem have led to the implementation of multiple maternal safety bundles, of which one was recently implemented at Womack Army Medical Center at Fort Bragg, NC. The goal of our study is to determine the effectiveness of this bundle in predicting postpartum hemorrhage in a military population. METHODS: Our study included patients that delivered from March through December 2017, who were deemed either moderate or high risk for postpartum hemorrhage. We looked at blood transfusion rates and risk factors for receiving transfusions. Numerical variables were compared using Student’s t or Wilcoxon Rank Sum as appropriate. Categorical variables were compared with the χ 2 Test of Independence or Fisher’s Exact. RESULTS: There were 423 patients who were considered ‘moderate’ risk (78.7%) or ‘high’ risk (21.3%) for postpartum hemorrhage. Of patients considered high risk, 11.1% required a blood transfusion, whereas significantly fewer patients classified as moderate risk required a transfusion (3.9%, P= .0150). The only significant risk factors for blood transfusion in this sample were patients with history of a prior postpartum hemorrhage ( P= .0027, assessed antepartum) and less than 70,000 platelets assessed intrapartum ( P= .0082). CONCLUSION: Our study shows that this bundle for obstetric hemorrhage was able to predict a higher rate of transfusion for those deemed high risk. Interestingly, our analysis showed only 2 risk factors of 26 were found to be statistically significant for blood transfusion.
In response to the COVID-19 pandemic, many hospital systems were forced to reduce operating room capacity and reallocate resources. The outcomes of these policies on the care of injured patients and the maintenance of emergency services have not been adequately reported.To evaluate whether the COVID-19 pandemic was associated with delays in urgent fracture surgery beyond national time-to-surgery benchmarks.This retrospective cohort study used data collected in the Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma among at 20 sites throughout the US and Canada and included patients who sustained open fractures or closed femur or hip fractures.COVID-19-era operating room restrictions were compared with pre-COVID-19 data.Surgery within 24 hours after injury.A total of 3589 patients (mean [SD] age, 55 [25.4] years; 1913 [53.3%] male) were included in this study, 2175 pre-COVID-19 and 1414 during COVID-19. A total of 54 patients (3.1%) in the open fracture cohort and 407 patients (21.8%) in the closed hip/femur fracture cohort did not meet 24-hour time-to-surgery benchmarks. We were unable to detect any association between time to operating room and COVID-19 era in either open fracture (odds ratio [OR], 1.40; 95% CI, 0.77-2.55; P = .28) or closed femur/hip fracture (OR, 1.01; 95% CI, 0.74-1.37; P = .97) cohorts. In the closed femur/hip fracture cohort, there was no association between time to operating room and regional COVID-19 prevalence (OR, 1.07; 95% CI, 0.70-1.64; P = .76).In this cohort study, there was no association between meeting time-to-surgery benchmarks in either open fracture or closed femur/hip fracture during the COVID-19 pandemic compared with before the pandemic. This is counter to concerns that the unprecedented challenges associated with managing the COVID-19 pandemic would be associated with clinically significant delays in acute management of urgent surgical cases and suggests that many hospital systems within the US were able to effectively implement policies consistent with time-to-surgery standards for orthopedic trauma in the context of COVID-19-related resource constraints.
This paper reports the results of the development of a self-report measure of innovativeness. The utility of such an instrument in human communication research is discussed, together with issues relating to its reliability, validity, and association with social desirability.
To determine the recovery priorities of extremity fracture patients during the subacute phase and the patient factors associated with variation in recovery priorities.Discrete choice experiment.Academic trauma center.One hundred ninety-eight patients with a fracture to the appendicular skeleton. Patients with severe traumatic brain injuries, spinal cord injuries, and non-English-speaking patients were excluded.The relative importance of clinical recovery, work-related recovery, and obtaining disability benefits after injury.In the subacute period, clinical recovery was the main priority for fracture patients (mean: 62%, SD: 5.3). Work-related recovery (mean: 27%, SD: 3.9) and the receipt of other disability benefits (mean: 11%, SD: 6.4) were each of significantly less importance. Heterogeneity was observed across these estimates based on the physical demands of preinjury employment, preinjury physical health, preinjury work status, health insurance type, and the severity of the fracture.Clinical recovery was of paramount importance for fracture patients during the subacute recovery phase. However, patients also valued resuming work and access to disability benefits. Understanding a patient's recovery priorities early in the clinical care pathway will enable the development of multidisciplinary care plans that are responsive to these priorities and, hence, deliver value-based health care.Level V. See Instructions for Authors for a complete description of levels of evidence.