Real-world evidence analysis of the impact of steroid-eluting implants on healthcare resource use among chronic rhinosinusitis patients undergoing sinus surgery.

OBJECTIVE: To compare healthcare resource use (HCRU) in patients undergoing sinus surgery with or without steroid-eluting sinus implants. METHODS: A retrospective, observational cohort study using real-world evidence data (OM1, Inc, Boston, MA, USA) was conducted on adult patients with chronic rhinosinusitis (CRS) with or without nasal polyps who underwent endoscopic sinus surgery between 2014 and 2019 and had at least 18 months of data both before and after surgery. Patients receiving implants ("implant cohort") were matched to patients who did not receive implants ("non-implant cohort") based on a propensity score developed using baseline characteristics. Chi-square for binary variables and analysis of variance tests for continuous variables were applied to compare HCRU measures. RESULTS: Comparison of the implant (N = 1983) and non-implant (N = 1983) cohorts during the 18-month follow-up period demonstrated significantly lower HCRU in those receiving implants, including all-cause outpatient visits (94.3% vs. 96.6%, p < .001), all-cause otolaryngologist visits (47.3% vs. 59.6%, p < .001) and all cause ER/urgent care visits (9.2% vs. 11.8%, p = .007), as well as sinus-related endoscopies (39.1% vs. 43.8%, p = .003). Although not statistically significant, fewer patients in the implant cohort had undergone repeat surgeries (4.6% vs. 5.3%, p = .273). CONCLUSION: Patients with steroid-eluting sinus implants had lower HCRU over a post-operative period of 18 months. These findings support the contention that reductions in HCRU may be achieved using steroid-eluting implants during sinus surgery.What is known on this topicChronic rhinosinusitis (CRS) causes severe symptoms that lead to poor quality of life.Endoscopic sinus surgery (ESS) is 76-98% effective in improving CRS patients' symptoms.Surgical outcomes can be compromised in the immediate post-operative period by scarring, adhesion formation, and early polyp recurrence.Oral and topical corticosteroid therapy has become integral to the maintenance of successful surgical outcomes, the management of post-operative scarring and edema, and the prevention of nasal polyp recurrence.Steroid-eluting sinus implants have been shown in clinical trials to improve postoperative outcomes after ESS by delivering localized, sustained release of corticosteroids directly onto inflamed sinus tissue.What this study addsThis observational study is one of the first to use real-world evidence to assess the effect of steroid-eluting sinus implants on healthcare resource use (HCRU) in patients with chronic rhinosinusitis who underwent sinus surgery with or without implants.Use of implants significantly reduced HCRU, including all-cause outpatient visits (94.3% vs 96.6%, p < .001), all-cause otolaryngologist visits (47.3% vs 59.6%, p < .001), and all-cause ER/urgent care visits (9.2% vs 11.8%, p = .007), as well as sinus endoscopy (39.1% vs 43.8%, p = .003).Use of implants had no significant effect on sinus procedures such as debridement and polypectomy, as well as sinus-related imaging such as CT, MRI, and x-ray.

A new approach to identifying patients with elevated risk for Fabry disease using a machine learning algorithm.

BACKGROUND: Fabry disease (FD) is a rare genetic disorder characterized by glycosphingolipid accumulation and progressive damage across multiple organ systems. Due to its heterogeneous presentation, the condition is likely significantly underdiagnosed. Several approaches, including provider education efforts and newborn screening, have attempted to address underdiagnosis of FD across the age spectrum, with limited success. Artificial intelligence (AI) methods present another option for improving diagnosis. These methods isolate common health history patterns among patients using longitudinal real-world data, and can be particularly useful when patients experience nonspecific, heterogeneous symptoms over time. In this study, the performance of an AI tool in identifying patients with FD was analyzed. The tool was calibrated using de-identified health record data from a large cohort of nearly 5000 FD patients, and extracted phenotypic patterns from these records. The tool then used this FD pattern information to make individual-level estimates of FD in a testing dataset. Patterns were reviewed and confirmed with medical experts. RESULTS: The AI tool demonstrated strong analytic performance in identifying FD patients. In out-of-sample testing, it achieved an area under the receiver operating characteristic curve (AUROC) of 0.82. Strong performance was maintained when testing on male-only and female-only cohorts, with AUROCs of 0.83 and 0.82 respectively. The tool identified small segments of the population with greatly increased prevalence of FD: in the 1% of the population identified by the tool as at highest risk, FD was 23.9 times more prevalent than in the population overall. The AI algorithm used hundreds of phenotypic signals to make predictions and included both familiar symptoms associated with FD (e.g. renal manifestations) as well as less well-studied characteristics. CONCLUSIONS: The AI tool analyzed in this study performed very well in identifying Fabry disease patients using structured medical history data. Performance was maintained in all-male and all-female cohorts, and the phenotypic manifestations of FD highlighted by the tool were reviewed and confirmed by clinical experts in the condition. The platform's analytic performance, transparency, and ability to generate predictions based on existing real-world health data may allow it to contribute to reducing persistent underdiagnosis of Fabry disease.

Harmonized Outcome Measures for Use in Non-Small Cell Lung Cancer Patient Registries and Clinical Practice.

BACKGROUND: Lung cancer is the leading cause of cancer-related death in the United States and globally, and many questions exist about treatment options. Harmonizing data across registries and other data collection efforts would yield a robust data infrastructure to help address many research questions. The purpose of this project was to develop a minimum set of patient and clinician relevant harmonized outcome measures that can be collected in non-small cell lung cancer (NSCLC) patient registries and clinical practice. METHODS: Seventeen lung cancer registries and related efforts were identified and invited to submit outcome measures. Representatives from medical specialty societies, government agencies, health systems, health information technology groups, patient advocacy organizations, and industry formed a stakeholder panel to categorize the measures and harmonize definitions using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). RESULTS: The panel reviewed 66 outcome measures and identified a minimum set of 8 broadly relevant measures in the OMF categories of patient survival, clinical response, events of interest, and resource utilization. The panel harmonized definitions for the 8 measures through in-person and virtual meetings. The panel did not reach consensus on 1 specific validated instrument for capturing patient-reported outcomes. The minimum set of harmonized outcome measures is broadly relevant to clinicians and patients and feasible to capture across NSCLC disease stages and treatment pathways. A pilot test of these measures would be useful to document the burden and value of the measures for research and in clinical practice. CONCLUSIONS: By collecting the harmonized measures consistently, registries and other data collection systems could contribute to the development research infrastructure and learning health systems to support new research and improve patient outcomes.

Review of literature of saddle nose deformity reconstruction and presentation of vomer onlay graft.

OBJECTIVE: Saddle nose deformity is a well-described condition that most commonly results from trauma or prior surgery. For larger saddle nose deformity defects, bone grafts are a reconstructive option that provide adequate structure for repair. One new technique for repair of these deformities is a vomerian bone onlay graft. We aim to provide a review of literature on autogenous repair of saddle nose deformities, as well as introduce a new technique in which the vomer bone is used as an onlay bone graft. METHODS: Literature review and case series. Five cases in which vomer onlay grafts were used for repair of saddle nose deformity were reviewed between January 2013 and December 2015. Aesthetic outcomes and postoperative complications were evaluated at subsequent follow-up visits in clinic. RESULTS: In all cases where vomer bone was harvested, the vomer onlay graft provided adequate structure to traverse the saddle nose deformity. No postoperative complications were observed in an 18 month follow-up period. CONCLUSION: Vomerian bone onlay grafts are a reconstructive option for saddle nose deformity and nasal dorsum defects. While septal cartilage is commonly used, and ethmoidal bone has been previously described as an option for composite graft reconstruction, vomer bone onlay grafting has not been well described in the literature. This method may be of use when previous nasal surgery has been performed and standard septal cartilage is not possible to harvest. The aesthetic outcomes following nasal dorsum reconstruction using onlay grafts are favorable, but long-term outcomes of these grafts require further study. LEVEL OF EVIDENCE: IV.

Comparison of Resource Utilization and Clinical Outcomes Following Screening with Digital Breast Tomosynthesis Versus Digital Mammography: Findings From a Learning Health System.

RATIONALE AND OBJECTIVES: To compare outcomes associated with breast cancer screening with digital mammography (DM) alone versus in combination with digital breast tomosynthesis (DBT) in a large representative cohort. MATERIALS AND METHODS: A total of 325,729 screening mammograms from 247,431 women were analyzed, across two healthcare systems, from June 2015 to September 2017. Patient level demographic, calculated risk levels, and clinical outcomes were extracted from radiology information system and electronic medical records. Multivariable regression modeling adjusting for institution, age, breast density, and first exam was conducted to compare patient characteristics, recall rates, time to biopsy and final diagnosis, clinical outcomes, and diagnostic performance. Participating institutions and the Coordinating Center received Institutional Review Board approval for a waiver of consent to collect and link data and perform analysis. RESULTS: A total of 194,437 (59.7%) screens were DBT versus 131,292 (40.3%) with DM. Women with dense breasts and higher calculated risk were more likely to be screened with DBT. Recall rates were lower for DBT overall (8.83% DBT vs 10.98% DM, adjusted odds ratio, 95% confidence interval = 0.85, 0.83-0.87) and across all age groups, races, and breast densities, and at facilities that used predominantly DBT (8.05%) versus predominantly DM (11.22%), or a combination (10.73%). The most common diagnostic pathway after recall was mammography and ultrasound. Women recalled from DBT were more likely to proceed directly to ultrasound. The median time to biopsy (18 vs 22 days) and final diagnosis (10 vs 13 days) was shorter for DBT. The adjusted cancer rate, cancer detection rate, and specificity were higher for DBT. CONCLUSION: DBT demonstrated a more efficient screening pathway and improved quality measures with lower recall rates in all patient types, reduced diagnostic mammography and shorter time to biopsy and final diagnosis.

The impact of surgical trainee participation on sinus surgery outcomes.

OBJECTIVES/HYPOTHESIS: To determine the effect of otolaryngology trainee participation on clinical outcomes in patients who undergo endoscopic sinus surgery (ESS) for chronic rhinosinusitis. STUDY DESIGN: Secondary analysis of prospectively collected data. METHODS: Patients enrolled in a sinus surgery outcomes study between May 2011 and March 2013 were stratified into two groups--those who were operated on by an attending alone and those operated on by an attending with a trainee present (resident, fellow, or both). Patients completed quality of life (QOL) surveys including the Chronic Sinusitis Survey (CSS), 22-item Sino-Nasal Outcome Test (SNOT-22), and EuroQol 5-dimension survey preoperatively and 1 year postoperatively. Operative time, estimated blood loss (EBL), complication rates, and survey scores were compared between groups. RESULTS: The study population consisted of 452 patients. The attending alone (n = 119) and trainee (n = 333) groups were statistically comparable in terms of patient demographics, disease severity, and extent of surgery. Mean operative time was significantly shorter in the attending-alone group (80.0 vs. 90.6 minutes, P < .01). Mean EBL (105 mL attending vs. 117 mL trainee, P = .39) and complication rates (3.3% attending vs. 0.6% trainee, P = .07) were similar between groups. Observed changes in QOL measures following ESS were comparable between groups, although absolute improvement in the SNOT-22 scores (19.0 attending vs. 24.5 trainee, P = .05) did show a trend toward greater improvement in the trainee group. CONCLUSIONS: Trainee participation in ESS is associated with prolongation in surgical time; however, such participation was not found to adversely affect patient safety or clinical outcomes. LEVEL OF EVIDENCE: 2b.

Impact of treatment strategies for open angle glaucoma on intraocular pressure: the RiGOR study.

AIMS: The RiGOR study's primary outcome measure was a 15% reduction in intraocular pressure (IOP) for patients with open-angle glaucoma at 1 year. METHODS: Patients received treatment according to the ophthalmologist's usual practice. RESULTS: A higher proportion of patients in the incisional and other surgery group achieved a 15% reduction in IOP than in the laser surgery or additional medication groups (82, 57, and 57% respectively). In multivariate regression analyses, incisional surgery patients were 2.7-times as likely as patients treated with additional medication to achieve a 15% reduction in IOP (odds ratio: 2.67; 95% CI: 2.01-3.57). CONCLUSION: Incisional and other surgical procedures are effective treatments. There were no differences in treatment response by race or ethnicity.

Quality of life and visual acuity outcomes in the Registry in Glaucoma Outcomes Research study.

AIMS: The RiGOR study evaluated the association of treatment and patient-reported outcomes for open-angle glaucoma patients. METHODS: The Glaucoma Symptom Scale (National Eye Institute-Visual Function Questionnaire (NEI-VFQ) and visual acuity (VA) were collected as quality of life measures. RESULTS: The proportion of patients with improvement of at least two lines of vision was highest in the incisional surgery group (14.2% compared with 9.9% for laser surgery and 10.9% for additional medication). CONCLUSION: No clinically relevant differences were seen in benefit for the laser surgery or incisional surgery groups compared with additional medications for the Glaucoma Symptom Scale or NEI-VFQ measures or subscales. Differences in quality of life by race need to be explored in further studies.

RiGOR: a prospective observational study comparing the effectiveness of treatment strategies for open-angle glaucoma.

AIMS: The RigOR study was designed to assess comparative effectiveness of medications, laser trabeculoplasty and incisional surgery in patients with open-angle glaucoma (OAG) in the community initiating a new or additional course of therapy as judged necessary by their ophthalmologist. This paper focuses specifically on demographic and clinical characteristics of OAG patients at enrollment. PATIENTS & METHODS: A total of 2597 with OAG already on medical therapy were enrolled from 45 community and academic practices throughout the USA. RESULTS: Overall, 784 (30%) patients were treated with laser surgery, 436 with other surgical procedures (17%), and 1377 with additional medication (53%). Patients had mild (35%) or moderate (31%) glaucoma, with 28% with severe glaucoma. CONCLUSION: The RiGOR study enrolled a diverse population and will provide valuable information regarding visual function and treatment patterns among different racial/ethnic populations. African-American and Hispanic patients entered the study with poorer visual acuity and more severe glaucoma.

Practice patterns and treatment changes for open-angle glaucoma: the RiGOR study.

AIMS: The RiGOR study provides a current picture of the types of glaucoma treatment over 12 months. METHODS: Patients were identified and enrolled at the time of decision to proceed with laser surgery procedure or other procedure such as incisional surgery or drainage device implantation, or initiation of a new or additional course of therapy with medication for glaucoma treatment. RESULTS: The most frequent type of treatments were prostaglandin analogues (60%) among patients with additional medication, selective laser trabeculoplasty (87%) among patients with laser surgery and trabeculectomy (57%) among patients with incisional surgery. CONCLUSION: For 36% of patients, a treatment cascade involves two or more therapies over a year. This demonstrates the complex nature of open-angle glaucoma treatment.

EQ-5D-derived health utility values in patients undergoing surgery for chronic rhinosinusitis.

OBJECTIVES/HYPOTHESIS: Health utility value (HUV) is an index used to measure health-related quality of life for the valuation and comparison of treatments. The Euroqol 5-Dimension (EQ-5D) questionnaire is a widely used method for determining HUV, but it has not been applied for this purpose in patients with chronic rhinosinusitis (CRS) who undergo sinus surgery. STUDY DESIGN: Prospective cohort study. METHODS: Patients with CRS, who were recruited from 11 different otolaryngologic practices, completed the EQ-5D questionnaire at baseline, as well as 3, 12, and 24 months after surgery. HUVs calculated from the results of this questionnaire were compared to those reported in the general U.S. population and to patients suffering from other chronic diseases. RESULTS: Baseline EQ-5D surveys were completed by 242 patients. Mean baseline HUV (standard deviation) was 0.81 (0.13). Female gender, revision surgery, and the use of intraoperative image guidance were associated was significantly lower baseline values. HUV rose at 3 months to 0.89 (0.12) and remained improved at 12 months 0.88 (0.10) and 24 months 0.89 (0.10) (P < 0.001). Baseline HUV in CRS (0.81[0.13]) is lower than the general U.S. population (0.85 [0.18]) and appears appropriately positioned among other common chronic conditions including asthma (0.82-0.92), migraine (0.81-0.91), and seasonal allergies (0.94). CONCLUSIONS: Sinus surgery provides improvement in HUV in patients with CRS. These values may be paired with costs of care to perform cost-utility analysis on this group of patients. LEVEL OF EVIDENCE: 2c.

The EQ-5D: a new tool for studying clinical outcomes in chronic rhinosinusitis.

OBJECTIVES/HYPOTHESIS: To describe the role and applicability of the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) questionnaire for the assessment of general health-related quality of life in patients with chronic rhinosinusitis. STUDY DESIGN: Prospective cohort study. METHODS: The EQ-5D-5L was administered to 462 patients with refractory chronic rhinosinusitis before and 3 months after sinus surgery. Preoperative and postoperative scores across each of five health dimensions were analyzed and the results compared to those obtained from two widely used chronic rhinosinusitis outcomes instruments: the Chronic Sinusitis Survey (CSS) and SinoNasal Outcomes Test-22 (SNOT-22). RESULTS: Three hundred and fifty patients completed the five questions and visual analog scale (VAS) of the EQ-5D at baseline and at 3 months for a response rate of 75.8%. There were no incomplete questionnaires. The frequency of patients reporting problems in the EQ-5D domains of pain/discomfort, anxiety/depression, and usual activities decreased following sinus surgery (74.3% vs. 34.4%, 48.6% vs. 31.4%, and 30.6% vs. 19.4%, respectively; all P < 0.001). The domains of mobility and self-care did not demonstrate statistically significant change. EQ-5D VAS (standard deviation) improved from 73.4 (16.9) before surgery to 82.0 (14.4) after surgery (P < 0.001). Preoperative VAS correlated with SNOT-22 scores (Pearson coefficient of 0.50; P < 0.01). Postoperative change in VAS and SNOT-22 scores demonstrated moderate correlation (Pearson coefficient of 0.36, P < 0.01). CONCLUSION: The EQ-5D is a general health measure with sensitivity to clinical change in rhinosinusitis that support its use for monitoring patient outcomes. The limited response burden and ability to directly calculate health utility make it an attractive tool for rhinosinusitis outcomes research.

Long-Term Outcomes in Sinus Surgery: A New Tool for Measuring Health-Related Quality of Life.

OBJECTIVE: The 6-question EuroQol 5-Dimension Health Assessment (EQ-5D) is a widely used, simple instrument that monitors general health-related quality of life (HRQoL) in chronic disease. It has not previously been applied to US patients undergoing endoscopic sinus surgery (ESS). STUDY DESIGN: Prospective cohort study. SETTING: Academic Medical Center. SUBJECTS AND METHODS: The study population consisted of 267 patients with chronic rhinosinusitis (CRS) who completed 2 disease-specific instruments-the Chronic Sinusitis Survey (CSS) and the Sinonasal Outcomes Test-22 (SNOT-22)-and 1 general health-related quality-of-life instrument-the EQ-5D-before and after ESS for CRS. Baseline scores were compared to those collected 3 and 12 months after surgery and to the general US population. RESULTS: Surveys were completed at all time points by 186 patients, for a response rate of 69.7%. Patients with CRS, when compared to the US population, reported more problems in the domains of pain/discomfort (73.1% vs 40.8%, P < .01), anxiety/depression (50.5% vs 26.4%, P < .01), and usual activities (30.6% vs 15.0%, P < .01). One year following ESS, there was a significant decrease in patients who reported problems with pain/discomfort (54.3%, P < .001), anxiety/depression (30.6%, P < .001), and usual activities (21.5%, P < .01). After surgery, CRS anxiety/depression scores were no different from those of the US general population. Chronic Sinusitis Survey and SNOT-22 scores demonstrated similar postoperative improvements. CONCLUSION: The EQ-5D assessment provides meaningful general health outcomes data with low patient burden. Application of this instrument demonstrated long-term improvement in the quality of life of patients who undergo sinus surgery.

Optimizing total facial nerve patient management for effective clinical outcomes research.

IMPORTANCE: Assessment of outcomes in patients with facial paralysis is challenging owing to the lack of objective tools to evaluate facial function and suboptimal data collection. OBJECTIVE: To describe a methodology for prospective evaluation of patients with facial paralysis that permits optimal assessment of clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS: At the Massachusetts Eye and Ear Infirmary, we have treated over 2000 patients with facial nerve injury since 2002. To better quantify and improve our outcomes, we have developed what we now believe represents a systematic method for the previsit evaluation, intake, management, and follow-up of our facial nerve patients to optimize data collection for the purposes of clinical outcome studies, as detailed in this retrospective descriptive study. RESULTS: Data collection is often poor if there is not a specific individual delegated to the task and is particularly challenging in the intraoperative setting. Retrospective acquisition of data are inherently less accurate and time consuming. A user-friendly searchable database is required to use the collected data. CONCLUSIONS AND RELEVANCE: Clinical outcomes research in the field of facial paralysis requires meticulous attention to comprehensive data collection at appropriate time points, precision photography, and the use of available quality of life and objective measurement tools. Ideally, a standardized approach for data collection would be adopted that would permit multi-institutional data analysis to improve the quality of outcomes research currently available. LEVEL OF EVIDENCE: NA.

Outcomes of fat injection laryngoplasty in unilateral vocal cord paralysis.

OBJECTIVE: To analyze outcomes following fat injection laryngoplasty in patients with unilateral vocal cord paralysis. DESIGN: Longitudinal outcomes evaluation study. SETTING: Tertiary referral voice center. PATIENTS: Thirty-three consecutive patients with unilateral vocal cord paralysis undergoing autologous fat injection laryngoplasty with preoperative and serial postoperative follow-up at Chang Gung Memorial Hospital, Taipei, Taiwan. INTERVENTION: Autologous fat injection laryngoplasty. MAIN OUTCOME MEASURES: Voice laboratory measurements, Voice Outcome Survey, and 36-item Short Form Health Survey. RESULTS: Except for the physical functioning dimension of global health, voice-related subjective outcomes and acoustic variables of the patients significantly improved after surgery (P < .05). Compared with population norms, the mean (SD) scores of patients were inferior on the 36-item Short Form Health Survey dimensions of physical functioning (80.7 [22.3] vs 90.2 [17.4]) and role functioning-physical problems (65.0 [36.2] vs 80.2 [36.2]). Overall, 88.9% (24 of 27) of the patients were satisfied with their surgery. CONCLUSIONS: Fat injection laryngoplasty seems to be effective in enhancing acoustic and quality of life outcomes in patients with unilateral vocal cord paralysis. The effect is sustainable over 12 months.

Epidemiology of bisphosphonate-related osteonecrosis of the jaws: the utility of a national registry.

PURPOSE: Little is known about the epidemiology of osteonecrosis of the jaws. To date, no population-based studies have rigorously evaluated risk factors, treatment factors, or outcomes. We aimed to perform such a study. MATERIALS AND METHODS: We reviewed the literature for epidemiologic studies on osteonecrosis of the jaws. RESULTS: Current epidemiologic information is generally derived from anecdotal reports or case series from small institutions. Estimates that have been provided in some reports have questionable validity because of a lack of standardized case definitions, clearly defined source populations, and clear methods for obtaining (or confirming) full reporting. Population-based prospective registries are capable of answering and informing several of the outstanding questions about bisphosphonate-related osteonecrosis of the jaws/osteonecrosis of the jaws. CONCLUSION: A population-based registry that collects systematic information on patient characteristics, treatments, and outcomes is essential to filling the gaps in our knowledge and understanding of bisphosphonate-related osteonecrosis of the jaws.

Selective transcutaneous delivery of energy to porcine soft tissues using Intense Ultrasound (IUS).

OBJECTIVE: Various energy delivery systems have been utilized to treat superficial rhytids in the aging face. The Intense Ultrasound System (IUS) is a novel modality capable of transcutaneously delivering controlled thermal energy at various depths while sparing the overlying tissues. The purpose of this feasibility study was to evaluate the response of porcine tissues to various IUS energy source conditions. Further evaluation was performed of the built-in imaging capabilities of the device. MATERIALS AND METHODS: Simulations were performed on ex vivo porcine tissues to estimate the thermal dose distribution in tissues after IUS exposures to determine the unique source settings that would produce thermal injury zones (TIZs) at given depths. Exposures were performed at escalating power settings and different exposure times (in the range of 1-7.6 J) using three IUS handpieces with unique frequencies and focal depths. Ultrasound imaging was performed before and after IUS exposures to detect changes in tissue consistency. Porcine tissues were examined using nitro-blue tetrazolium chloride (NBTC) staining sensitive for thermal lesions, both grossly and histologically. The dimensions and depth of the TIZs were measured from digital photographs and compared. RESULTS: IUS can reliably achieve discrete, TIZ at various depths within tissue without surface disruption. Changes in the TIZ dimensions and shape were observed as source settings were varied. As the source energy was increased, the thermal lesions became larger by growing proximally towards the tissue surface. Maximum lesion depth closely approximated the pre-set focal depth of a given handpiece. Ultrasound imaging detected well-demarcated TIZ at depths within the porcine muscle tissue. CONCLUSION: This study demonstrates the response of porcine tissue to various energy dose levels of Intense Ultrasound. Further study, especially on human facial tissue, is necessary in order to understand the utility of this modality in treating the aging face and potentially, other cosmetic applications.

The American Orthopaedic Association's "own the bone" initiative to prevent secondary fractures.

BACKGROUND: The American Orthopaedic Association initiated its Own the Bone pilot project in 2005 in order (1) to assess current orthopaedic practices for the prevention of secondary fractures in adult patients who have sustained a low-energy fracture (fragility fracture), (2) to pilot quality-improvement tools designed to improve the application of evidence-based strategies for the prevention of secondary fractures, and (3) to identify barriers to the broader implementation of the Own the Bone project and explore how to overcome them. METHODS: The ten-month pilot project took place at fourteen sites (thirteen inpatient sites and one outpatient site) and involved 635 participants with a median age of seventy-seven years. The primary outcome measures were the percentages of patients who received (1) counseling on calcium and vitamin-D supplementation, weight-bearing exercise, smoking cessation, and fall prevention, (2) bone mineral density testing, and (3) pharmaceutical intervention to prevent or treat osteoporosis. Secondary outcome measures focused on improved information flow and included the percentage of patients whose physicians were sent a letter recommending the evaluation and treatment of the fracture and the percentage of patients who received a letter recommending that they see their primary-care physician for evaluation and treatment of osteoporosis associated with the fracture. RESULTS: The intervention produced significant improvements (p < 0.0001) in patient counseling on calcium and vitamin-D supplementation, exercise, fall prevention, and communication with primary-care providers and the patients themselves. No improvements were shown in the ordering of bone mineral density testing or the prescription of pharmacotherapy. The most significant improvements (p < 0.0001) were in improved communication with primary-care physicians and in efforts to educate patients about their risk of future fracture. CONCLUSIONS: The Own the Bone initiative offers tools to improve the prevention of secondary fractures and a structure to monitor physician compliance. The American Orthopaedic Association plans to use these quality-improvement tools to stimulate change in both physician and patient behavior following low-energy fractures.