As a result of the many different potential locations to be treated, it is still difficult to evaluate the indications for efficacy and safety of non-coronary percutaneous transluminal angioplasty (PTA) and stenting versus surgical methods, such as endarterectomy or bypass grafts. This paper reviews pertinent data published in the last 5-10 years and gives an overview of the main peripheral minimally invasive vascular interventional fields.
Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6-and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment.Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional effort s to improve the outcomes of these challenging injuries are still needed.
Passive acoustic recordings were used to study the behavior of red hind (Epinephelus guttatus) at spawning aggregation sites off of Puerto Rico and Mona Island, and goliath grouper (Epinephelus itajara) and red grouper (Epinephelus morio) on the West Florida Shelf. The sounds produced by each species were unique, low-frequency pulsed sounds and associated with reproductive-related behavior. Male red hind produced sounds composed of a series of pulses that graded into a tonal-like sound, mostly during territorial patrolling. Long-term acoustic recorder (LARS) data from the west coast of Puerto Rico and Mona Island showed similar diel periodicities of sound production of red hind, but had different monthly peaks in sound production. Goliath grouper sounds consisted of low-frequency individual pulses (50-100 Hz) that are consistent with sounds produced by a large fish, and showed lunar periodicity in sound production. Peaks in sound production occurred nightly after midnight, but sounds were also produced throughout the day. Sound production and spawning by red grouper was recorded using a remotely operated vehicle (ROV) at depths of 80-100 m. Passive acoustic techniques can provide synoptic, long-term time series of sound production associated with reproductive activities of soniferous species at widely spaced sites.
Introduction
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.
Methods
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.
Results
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).
Conclusions
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.
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