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Robert S. Kirsner MD PhD Wolfgang Vanscheidt MD David H. Keast MD John C. Lantis MD II Cyaandi R. Dove DPM Shawn M. Cazzell DPM Mher Vartivarian DPM Matthias Augustin MD William A. Marston MD Nicholas D. McCoy BS D. Innes Cargill PhD Tommy D. Lee MSHS Jaime E. Dickerson PhD Jr Herbert B. Slade MD for the HP‐ Study Group 《Wound repair and regeneration》2016,24(5):894-903
In 2012 we reported promising results from a phase 2 clinical trial of HP802‐247, a novel spray‐applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802‐247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe. The primary endpoint was the proportion of ulcers with confirmed closure at the end of 12 weeks of treatment. An investigation into the root cause for the failure of HP802‐247 to show efficacy in these two phase 3 trials was initiated immediately following the initial review of the North American trial results. Four hundred twenty‐one patients were enrolled in the North American (HP802‐247, 211; Vehicle 210) and 252 in the European (HP802‐247, 131; Vehicle 121) trials. No difference in proportion of closed ulcers at week 12 was observed between treatment groups for either the North American (HP802‐247, 61.1%; Vehicle 60.0%; p = 0.5896) or the European (HP802‐247, 47.0%; Vehicle 50.0%; p = 0.5348) trials. Thorough investigation found no likelihood that design or execution of the trials contributed to the failure. Variability over time during the trials in the clinical response implicated the quality of the cells comprising HP802‐247. Concordance between the two separate, randomized, controlled trials with distinct, nonoverlapping investigative sites and independent monitoring teams renders the possibility of a Type II error vanishingly small and provides strong credibility for the unexpected lack of efficacy observed. The most likely causative factors for the efficacy failure in phase 3 was phenotypic change in the cells (primarily keratinocytes) leading to batch to batch variability due to the age of the cell banks. 相似文献
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Kristin Lees Haggerty PhD Gary Epstein-Lubow MD Lynn H. Spragens MBA Rebecca J. Stoeckle BA Leslie C. Evertson DNP RN GNP-BC Lee A. Jennings MD MSHS David B. Reuben MD 《Journal of the American Geriatrics Society》2020,68(11):2478-2485
Access to comprehensive dementia care is limited. Recent changes in billing for professional services, including new physician fee schedule codes, encourage clinicians to provide new services; however, current reimbursement does not cover costs for all needed elements of dementia care. The Payment Model for Comprehensive Dementia Care Conference convened more than 50 national experts from diverse perspectives to review promising strategies for payment reform including ways to accelerate their adoption. Recommendations for reform included payments for services to family caregivers; new research to determine success metrics; education for consumers, providers, and policymakers; and advancing a population health model approach to tier coverage based on risk and need within a health system. 相似文献
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David B. Reuben MD Thomas M. Gill MD Alan Stevens PhD Jeff Williamson MD Elena Volpi MD PhD Maya Lichtenstein MD Lee A. Jennings MD MSHS Zaldy Tan MD Leslie Evertson DNP RN GNP-BC David Bass PhD Lisa Weitzman MSSA LISW-S ASW-G C-ASWCM Martie Carnie Nancy Wilson MA MSW Katy Araujo MPH Peter Charpentier MPH Can Meng MS MPH Erich J. Greene PhD James Dziura PhD Jodi Liu PhD MSPH MSE BSE Erin Unger Mia Yang MD Katherine Currie BSPH MAT Kristin M. Lenoir MPH Aval-NaʼRee S. Green MD Sitara Abraham MPH Ashley Vernon MPH Rafael Samper-Ternent MD PhD Mukaila Raji MD MSc Roxana M. Hirst MS Rebecca Galloway PT PhD Glen R. Finney MD Ilene Ladd MS Alanna Kulchak Rahm PhD MS CGC Pamela Borek MSN RN-C Peter Peduzzi PhD 《Journal of the American Geriatrics Society》2020,68(11):2492-2499
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Karl A. Lorenz MD MSHS Sydney M. Dy MD MPH Arash Naeim MD PhD Anne M. Walling MD Homayoon Sanati MD Patricia Smith MS Roberta Shanman MS Carol P. Roth RN MPH Steven M. Asch MD MPH 《Journal of pain and symptom management》2009,37(6):943-964
Patients and physicians often cite symptom control as one of their most important goals in cancer care. Despite this, a previous systematic review found few tools for evaluating the quality of supportive cancer management. We developed a comprehensive set of quality indicators for evaluating pain and nonpain symptom management as well as care planning needs in cancer patients. Based on the prevalence and quality-of-life data, clinician-researchers prioritized pain, psychosocial distress, dyspnea, nausea and vomiting, fatigue and anorexia, treatment-associated toxicities, and information and care planning for quality-indicator development. Using search terms and selection criteria, we identified English-language documents from Medline (1997–2007) and Internet-based searches. Based on this evidence, clinician-reviewers proposed process quality indicators. We then used the VA Health Services Research and Development (VA HSR & D) appropriateness methods to compile the ratings of a multidisciplinary, international expert panel of the validity and feasibility of each indicator. The panel judged 92 out of 133 (69%) proposed quality indicators valid and feasible (15 out of 23 pain, 5 out of 6 depression, 8 out of 11 dyspnea, 15 out of 19 nausea and vomiting, 13 out of 26 fatigue and anorexia, 23 out of 32 other treatment-associated toxicities, and 13 out of 16 information and care planning). Of the final indicators, 67 are potentially useful for inpatient and 81 for outpatient evaluation, and 26 address screening, 12 diagnostic evaluation, 20 management, and 21 follow-up. These quality indicators provide evidence-explicit tools for measuring processes critical to ensuring high-quality supportive cancer care. Research is needed to characterize adherence to recommended practices and to evaluate the use of these measures in quality improvement efforts. 相似文献
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Michelle D. Seelig MD MSHS Elizabeth M. Yano PhD MSPH Bevanne Bean-Mayberry MD MHS Andy B. Lanto MA Donna L. Washington MD MPH 《Women's health issues》2008,18(3):167-173
PURPOSE: The optimum approach to providing the Congressionally mandated gender-specific services for which women veterans are eligible is unknown. We evaluated onsite availability of gynecologic services, clinic type and staffing arrangements, and the impact of having a gynecology clinic (GYN) and/or an obstetrician gynecologist (OBGYN) routinely available. METHODS: We analyzed data from the 2001 national VHA Survey of Women Veterans Health Programs and Practices (n = 136 sites; response rate, 83%). We assessed availability of gynecologic services, and evaluated differences in availability by clinic type (designated women's health provider in primary care [PC], separate women's health clinic for primary care [WHC], and/or separate GYN) and staffing arrangements (OBGYN routinely involved versus not). MAIN FINDINGS: Out of 133 sites, 77 sites (58%) offered services through a GYN and 56 sites (42%) did not have GYN. Seventy-two (54%) sites had a WHC. More sites with an OBGYN provided endometrial biopsies (91% vs. 20%), IUD insertion (85% vs. 14%), infertility evaluation (56% vs. 23%), infertility treatment (25% vs. none), gynecologic surgery (65 vs. 28%), p < .01. In comparison to sites without WHC, those with WHC were more likely to offer services onsite: endometrial biopsy odds ratio (OR) 6.0 (95% confidence interval [CI], 2.0-18.1); IUD insertion 4.4 (1.6-12.2); infertility evaluation 2.8 (1.2-6.3); and gynecologic surgery 2.3 (1.0-5.4). CONCLUSION: As the VA develops strategic plans for accommodating the growing number of women veterans, leaders should consider focusing on establishing WHC for primary care and routine availability of OBGYN or other qualified clinicians, rather than establishing separate GYN. 相似文献
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Quality in Surgery: Current Issues for the Future 总被引:2,自引:0,他引:2
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Low‐Dose Parenteral Soybean Oil for the Prevention of Parenteral Nutrition–Associated Liver Disease in Neonates With Gastrointestinal Disorders 下载免费PDF全文
Kara L. Calkins MD Thomas Havranek MD Lorraine I. Kelley‐Quon MD MSHS Laura Cerny MD Martiniano Flores MS Tristan Grogan MS Stephen B. Shew MD 《JPEN. Journal of parenteral and enteral nutrition》2017,41(3):404-411
Background: Neonates with gastrointestinal disorders (GDs) are at high risk for parenteral nutrition–associated liver disease (PNALD). Soybean‐based intravenous lipid emulsions (S‐ILE) have been associated with PNALD. This study's objective was to determine if a lower dose compared with a higher dose of S‐ILE prevents cholestasis without compromising growth. Materials and Methods: This multicenter randomized controlled pilot study enrolled patients with GDs who were ≤5 days of age to a low dose (~1 g/kg/d) (LOW) or control dose of S‐ILE (~3 g/kg/d) (CON). The primary outcome was cholestasis (direct bilirubin [DB] >2 mg/dL) after the first 7 days of age. Secondary outcomes included growth, PN duration, and late‐onset sepsis. Results: Baseline characteristics were similar between the LOW (n = 20) and CON groups (n = 16). When the LOW group was compared with the CON group, there was no difference in cholestasis (30% vs 38%, P = .7) or secondary outcomes. However, mean ± SE DB rate of change over the first 8 weeks (0.07 ± 0.04 vs 0.3 ± 0.09 mg/dL/wk, P = .01) and entire study (0.008 ± 0.03 vs 0.2 ± 0.07 mg/dL/wk, P = .02) was lower in the LOW group compared with the CON group. Conclusion: In neonates with GDs who received a lower dose of S‐ILE, DB increased at a slower rate in comparison to neonates who received a higher dose of S‐ILE. Growth was comparable between the groups. This study demonstrates a need for a larger, randomized controlled trial comparing 2 different S‐ILE doses for cholestasis prevention in neonates at risk for PNALD. 相似文献