Patients with pelvic and acetabular fractures often have considerable pain in the perioperative period. Regional anesthesia (RA) including peripheral nerve blocks and spinal analgesia may reduce pain. However, the real-world impact of these modalities on inpatient opioid consumption and outpatient opioid demand is largely unknown. The purpose of this study was to evaluate the impact of perioperative RA on inpatient opioid consumption and outpatient opioid demand.
Methods
This is a retrospective, observational review of inpatient opioid consumption and outpatient opioid demand in all patients ages 18 and older undergoing operative fixation of pelvic and acetabular fractures at a single Level, I trauma center from 7/1/2013–7/1/2018 (n = 205). Unadjusted and adjusted analyses were constructed to evaluate the impact of RA on inpatient opioid consumption and outpatient opioid demand while controlling for age, sex, race, body mass index (BMI), smoking, chronic opioid use, ASA score, injury mechanism, additional injuries, open injury, and additional inpatient surgery.
Results
Adjusted models demonstrated increases in inpatient opioid consumption in patients with RA (12.6 estimated OE’s without RA vs 16.1 OE’s with RA from 48 to 72 h post-op, p < 0.05) but no significant differences at other timepoints (17.5 estimated OE’s without RA vs 16.8 OE’s with RA from 0 to 24 h post-op, 15.3 vs 17.1 from 24 to 48 h post-op, p > 0.05). Estimated cumulative outpatient opioid demand was significantly higher in patients with RA at discharge to 90 days post-op (and 156.8 vs 207.9 OE’s to 90 days, p < 0.05) but did not differ significantly before that time (121.5 OE’s without RA vs 123.9 with RA from discharge to two weeks, 145.2 vs 177.2 OE’s to 6 weeks, p > 0.05).
Discussion
In pelvis and acetabulum fracture surgery, RA was associated with increased inpatient and outpatient opioid demand after adjusting for baseline patient and treatment characteristics. Regional anesthesia may not be beneficial for these patients.
Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.
Methods
ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment.
Results
The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized.
Conclusions
We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.
Introduction: Pediatric obesity is a serious public health concern. Five medications have been approved by the Food and Drug Administration (FDA) for chronic weight management in adults with obesity, when used as an adjunct to lifestyle modification. Orlistat is the only FDA-approved medication for pediatric patients aged 12 years and above.
Areas covered: This paper summarizes safety and efficacy data from clinical trials of weight loss medications conducted among pediatric samples. Relevant studies were identified through searches in PubMed.
Expert opinion: Orlistat, as an adjunct to lifestyle modification, results in modest weight losses and may be beneficial for some pediatric patients with obesity. However, gastrointestinal side effects are common and may limit use. In adults taking orlistat, rare but severe adverse events, including liver and renal events, have been reported. Recent pediatric pharmacokinetic studies of liraglutide have demonstrated similar safety and tolerability profiles as found in adults, with gastrointestinal disorders being the most common adverse events. Clinical trials are needed of liraglutide, as well as other medications for obesity, that systematically evaluate their risks and benefits in pediatric patients. 相似文献
BackgroundLarge clinical trials established the benefits of sodium-glucose cotransporter 2 inhibitors in patients with diabetes and with heart failure with reduced ejection fraction (HFrEF). The early and significant improvement in clinical outcomes is likely explained by effects beyond a reduction in hyperglycemia.ObjectivesThe purpose of this study was to assess the effect of empagliflozin on left ventricular (LV) function and volumes, functional capacity, and quality of life (QoL) in nondiabetic HFrEF patients.MethodsIn this double-blind, placebo-controlled trial, nondiabetic HFrEF patients (n = 84) were randomized to empagliflozin 10 mg daily or placebo for 6 months. The primary endpoint was change in LV end-diastolic and -systolic volume assessed by cardiac magnetic resonance. Secondary endpoints included changes in LV mass, LV ejection fraction, peak oxygen consumption in the cardiopulmonary exercise test, 6-min walk test, and quality of life.ResultsEmpagliflozin was associated with a significant reduction of LV end-diastolic volume (?25.1 ± 26.0 ml vs. ?1.5 ± 25.4 ml for empagliflozin vs. placebo, respectively; p < 0.001) and LV end-systolic volume (?26.6 ± 20.5 ml vs. ?0.5 ± 21.9 ml for empagliflozin vs. placebo; p < 0.001). Empagliflozin was associated with reductions in LV mass (?17.8 ± 31.9 g vs. 4.1 ± 13.4 g, for empagliflozin vs. placebo, respectively; p < 0.001) and LV sphericity, and improvements in LV ejection fraction (6.0 ± 4.2 vs. ?0.1 ± 3.9; p < 0.001). Patients who received empagliflozin had significant improvements in peak O2 consumption (1.1 ± 2.6 ml/min/kg vs. ?0.5 ± 1.9 ml/min/kg for empagliflozin vs. placebo, respectively; p = 0.017), oxygen uptake efficiency slope (111 ± 267 vs. ?145 ± 318; p < 0.001), as well as in 6-min walk test (81 ± 64 m vs. ?35 ± 68 m; p < 0.001) and quality of life (Kansas City Cardiomyopathy Questionnaire-12: 21 ± 18 vs. 2 ± 15; p < 0.001).ConclusionsEmpagliflozin administration to nondiabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for sodium-glucose cotransporter 2 inhibitors in the treatment of HFrEF patients independently of their glycemic status. (Are the “Cardiac Benefits” of Empagliflozin Independent of Its Hypoglycemic Activity? [ATRU-4] [EMPA-TROPISM]; NCT03485222) 相似文献
ObjectivesTo assess levonorgestrel (LNG) and ulipristal acetate (UPA) availability in pharmacies in a metropolitan area.MethodsA cross-sectional survey was conducted of all identified pharmacies within 25 miles of an urban medical center in Kansas City, KS. We categorized the pharmacies as dedicated commercial (national chains), store-associated (affiliated with a general merchandise or grocery store), or independent. We assessed LNG and UPA availability or time to availability if not currently stocked.ResultsWe contacted 165 pharmacies. Of the 165 pharmacies, few stocked UPA (12/165, 7%) whereas the majority stocked oral LNG (128/165, 78%). Dedicated commercial pharmacies were more likely to carry UPA than store-associated and independent pharmacies (11/84 [13%] vs. 1/61 [1%] vs. 0/20, respectively; P = 0.016). Most pharmacies that did not stock UPA reported that they could obtain it within 24 hours (94/153, 62%). Dedicated commercial pharmacies were most likely report the ability to obtain UPA in 24 hours (P = 0.016).ConclusionFew pharmacies stock UPA, the most effective form of oral emergency contraception. Enhanced communication between medical providers and pharmacists within current laws and regulations could enhance patient access to UPA. 相似文献
We sought to evaluate the accuracy of assessing gestational age (GA) prior to first trimester medication abortion using last menstrual period (LMP) compared to ultrasound (U/S).
Study Design
We searched Medline, Embase and Cochrane databases through October 2013 for peer-reviewed articles comparing LMP to U/S for GA dating in abortion care. Two teams of investigators independently evaluated data using standard abstraction forms. The US Preventive Services Task Force and Quality Assessment of Diagnostic Accuracy Studies guidelines were used to assess quality.
Results
Of 318 articles identified, 5 met inclusion criteria. Three studies reported that 2.5–11.8% of women were eligible for medication abortion by LMP and ineligible by U/S. The number of women who underestimated GA using LMP compared to U/S ranged from 1.8 to 14.8%, with lower rates found when the sample was limited to a GA < 63 days. Most women (90.5–99.1%) knew their LMP, 70.8–90.5% with certainty.
Conclusion
Our results support that LMP can be used to assess GA prior to medication abortion at GA < 63 days. Further research looking at patient outcomes and identifying women eligible for medication abortion by LMP but ineligible by U/S is needed to confirm the safety and effectiveness of providing medication abortion using LMP alone to determine GA. 相似文献
