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Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON)
Malone, Mia; McDonald, Ryan; Vittitow, Alexandria; Chen, Jenny; Obi, Rita; Schatz, Dan; Tofighi, Babak; Garment, Annie; Goldfeld, Keith; Gold, Heather; Laska, Eugene; Rotrosen, John; Lee, Joshua D
BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. METHODS:This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120). RESULTS:We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported. CONCLUSIONS:XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.
PMID: 30986535
ISSN: 1559-2030
CID: 3810362
The Omission of Endocrine Therapy (ET) in Older Women with Stage I Estrogen-Receptor (ER)-Positive Breast Cancer Is Not Associated with a Higher Risk of Recurrence [Meeting Abstract]
Gerber, N. K.; Shao, H.; Chadha, M.; Gold, H.
ISI:000485671500050
ISSN: 0360-3016
CID: 4111912
Implementation and early adaptation of patient-reported outcome measures into an electronic health record: A technical report
Gold, Heather Taffet; Karia, Raj J; Link, Alissa; Lebwohl, Rachel; Zuckerman, Joseph D; Errico, Thomas J; Slover, James D; Buckland, Aaron J; Mann, Devin M; Cantor, Michael N
We integrated and optimized patient-reported outcome measures into the electronic health record to provide quantitative, objective data regarding patients' health status, which is important for patient care, payer contracts, and research. With a multidisciplinary team from information technology, clinical informatics, population health, and physician champions, we used formal human-computer interaction techniques and user-centered design to integrate several technology platforms and computerized adaptive testing for the National Institutes of Health Patient-Reported Outcomes Measurement Information System. The patient-reported outcome measure system leverages software frequently used by health systems and provides data for research and clinical care via a mobile-responsive web application using Symfony, with REDCap for configuring assessments and de-identified data storage. The system incorporates Oracle databases and Epic flowsheets. Patients complete patient-reported outcome measures, with data viewable in MyChart and Epic Synopsis Reports. Researchers can access data portals. The highly usable, successful patient-reported outcome measures platform is acceptable to patients and clinicians and achieved 73 percent overall completion rates.
PMID: 30516095
ISSN: 1741-2811
CID: 3520672
Physical Therapy or Arthroscopic Surgery for Treatment of Meniscal Tears: Is Noninferiority Enough?
Jazrawi, Laith; Gold, Heather T; Zuckerman, Joseph D
PMID: 30285160
ISSN: 1538-3598
CID: 3329032
Response to Nazarian et al regarding: "Cost-effectiveness of magnetic resonance imaging versus ultrasound for the detection of symptomatic full-thickness supraspinatus tendon tears" [Letter]
Gyftopoulos, Soterios; Guja, Kip E; Subhas, Naveen; Virk, Mandeep S; Gold, Heather T
PMID: 30093231
ISSN: 1532-6500
CID: 3226702
Association Between Guideline-Discordant Prostate Cancer Imaging Rates and Health Care Service Among Veterans and Medicare Recipients
Makarov, Danil V; Ciprut, Shannon; Walter, Dawn; Kelly, Matthew; Gold, Heather T; Zhou, Xiao-Hua; Sherman, Scott E; Braithwaite, Ronald Scott; Gross, Cary; Zeliadt, Steven
Importance/UNASSIGNED:Prostate cancer imaging rates appear to vary by health care setting. With the recent extension of the Veterans Access, Choice, and Accountability Act, the government has provided funds for veterans to seek care outside the Veterans Health Administration (VA). It is important to understand the difference in imaging rates and subsequent differences in patterns of care in the VA vs a traditional fee-for-service setting such as Medicare. Objective/UNASSIGNED:To assess the association between prostate cancer imaging rates and a VA vs fee-for-service health care setting. Design, Setting, and Participants/UNASSIGNED:This cohort study included data for men who received a diagnosis of prostate cancer from January 1, 2004, through March 31, 2008, that were collected from the VA Central Cancer Registry, linked to administrate claims and Medicare utilization records, and the Surveillance, Epidemiology, and End Results Program database. Three distinct nationally representative cohorts were constructed (use of VA only, use of Medicare only, and dual use of VA and Medicare). Men older than 85 years at diagnosis and men without high-risk features but missing any tumor risk characteristic (prostate-specific antigen, Gleason grade, or clinical stage) were excluded. Analysis of the data was completed from March 2016 to February 2018. Exposures/UNASSIGNED:Patient utilization of different health care delivery systems. Main Outcomes and Measures/UNASSIGNED:Rates of prostate cancer imaging were analyzed by health care setting (Medicare only, VA and Medicare, and VA only) among patients with low-risk prostate cancer and patients with high-risk prostate cancer. Results/UNASSIGNED:Of 98 867 men with prostate cancer (77.4% white; mean [SD] age, 70.26 [7.48] years) in the study cohort, 57.3% were in the Medicare-only group, 14.5% in the VA and Medicare group, and 28.1% in the VA-only group. Among men with low-risk prostate cancer, the Medicare-only group had the highest rate of guideline-discordant imaging (52.5%), followed by the VA and Medicare group (50.9%) and the VA-only group (45.9%) (P < .001). Imaging rates for men with high-risk prostate cancer were not significantly different among the 3 groups. Multivariable analysis showed that individuals in the VA and Medicare group (risk ratio [RR], 0.87; 95% CI, 0.76-0.98) and VA-only group (RR, 0.79; 95% CI, 0.67-0.92) were less likely to receive guideline-discordant imaging than those in the Medicare-only group. Conclusions and Relevance/UNASSIGNED:The results of this study suggest that patients with prostate cancer who use Medicare rather than the VA for health care could experience more utilization of health care services without an improvement in the quality of care.
PMID: 30646111
ISSN: 2574-3805
CID: 3594782
Influence of Extent of Lymph Node Evaluation on Survival for Pathologically Lymph Node Negative Non-Small Cell Lung Cancer
Becker, Daniel J; Levy, Benjamin P; Gold, Heather T; Sherman, Scott E; Makarov, Danil V; Schreiber, David; Wisnivesky, Juan P; Pass, Harvey I
OBJECTIVES: Despite previous retrospective reports that the number of lymph nodes resected at curative intent surgery for lung cancer correlates with overall survival (OS), no consensus exists regarding the minimal nor optimal number of lymph nodes to resect at curative lung cancer surgery. METHODS: We studied subjects in the Surveillance Epidemiology and End Results Database (SEER) diagnosed with non-small cell lung cancer between 2000 and 2011 who underwent either lobectomy or pneumonectomy and had pathologic negative nodal evaluation. We excluded patients with sublobar resection and/or no lymph node evaluation. We examined associations between number of lymph nodes evaluated and OS/lung cancer-specific survival by multivariable Cox regression; and predictors of evaluation of more lymph nodes. RESULTS: Among the 33,463 patients in our sample, a median of 7 lymph nodes were evaluated. We found that lung cancer-specific survival and OS improved with increasing lymph node evaluation up to 16 to 18 lymph nodes (hazard ratio, 0.77 [95% confidence interval, 0.70-0.85] and 0.78 [95% confidence interval, 0.72-0.86], respectively). There was little additional improvement in outcomes with evaluation of >16 to 18 lymph nodes. Blacks, Hispanics, females, and patients from distinct geographical regions were less likely to have 16 or more lymph nodes evaluated. CONCLUSIONS: There was a consistently increasing survival benefit associated with a more extensive lymph node evaluation at lung cancer resection, up to 16 to 18 lymph nodes removed. The median number of nodes evaluated was, however, only 7, suggesting that setting a goal of >/=16 examined lymph nodes may lead to improved survival outcomes, and reduce disparities in care.
PMID: 28301349
ISSN: 1537-453x
CID: 2490082
Time Trends in Characteristics of Patients Undergoing Primary Total Hip and Knee Arthroplasty in California, 2007-2010
Oh, Cheongeun; Slover, James D; Bosco, Joseph A; Iorio, Richard; Gold, Heather T
BACKGROUND:As the number of total hip and knee arthroplasty cases increases, it is important to understand the burden of factors that impact patient outcomes of these procedures. This article examined the time trends in key demographics, clinical characteristics, comorbidity burden (Deyo-Charlson Comorbidity Index [CCI]), and presence of depression in patients undergoing primary total hip arthroplasty and total knee arthroplasty using population-based, all-payer inpatient database, California Healthcare Cost and Utilization Project, from 2007 to 2010. METHODS:Chi-square tests and analysis of variance were used. Multivariate logistic regression analyses were also performed to compare the prevalence of depression in 2007 to later years. RESULTS:In the primary total hip arthroplasty cohort, the prevalence of depression significantly increased by 20%, mean age decreased by 0.4 years, mean length of stay (LOS) decreased by 0.5 days, and having a CCI score of ≥3 increased by 30% (P value < .001 for all) over the study period. Similarly, in the primary total knee arthroplasty cohort, the prevalence of depression increased by 23%, the mean age decreased by 0.4 years, mean LOS decreased by 0.4 days, and the prevalence of CCI score of ≥3 increased by 35% (P value < .001 for all). CONCLUSION/CONCLUSIONS:Despite the younger age of the joint arthroplasty population over time, we found increased prevalence of depression and comorbidity scores but shorter LOS. Further study is needed to determine the impact of the changing demographics of the total joint population and the best strategies to optimize their outcome with these procedures.
PMID: 29605148
ISSN: 1532-8406
CID: 3025952
Treatment for Symptomatic SLAP Tears in Middle-Aged Patients Comparing Repair, Biceps Tenodesis, and Nonoperative Approaches: A Cost-Effectiveness Analysis
Paoli, Albit R; Gold, Heather T; Mahure, Siddharth A; Mai, David H; Agten, Christoph A; Rokito, Andrew S; Virk, Mandeep S
PURPOSE/OBJECTIVE:To evaluate the cost-effectiveness of nonoperative management, primary SLAP repair, and primary biceps tenodesis for the treatment of symptomatic isolated type II SLAP tear. METHODS:A microsimulation Markov model was constructed to compare 3 strategies for middle-aged patients with symptomatic type II SLAP tears: SLAP repair, biceps tenodesis, or nonoperative management. A failed 6-month trial of nonoperative treatment was assumed. The principal outcome measure was the incremental cost-effectiveness ratio in 2017 U.S. dollars using a societal perspective over a 10-year time horizon. Treatment effectiveness was expressed in quality-adjusted life-years (QALY). Model results were compared with estimates from the published literature and were subjected to sensitivity analyses to evaluate robustness. RESULTS:Primary biceps tenodesis compared with SLAP repair conferred an increased effectiveness of 0.06 QALY with cost savings of $1,766. Compared with nonoperative treatment, both biceps tenodesis and SLAP repair were cost-effective (incremental cost-effectiveness ratio values of $3,344/QALY gained and $4,289/QALY gained, respectively). Sensitivity analysis showed that biceps tenodesis was the preferred strategy in most simulations (52%); however, for SLAP repair to become cost-effective over biceps tenodesis, its probability of failure would have to be lower than 2.7% or the cost of biceps tenodesis would have to be higher than $14,644. CONCLUSIONS:When compared with primary SLAP repair and nonoperative treatment, primary biceps tenodesis is the most cost-effective treatment strategy for type II SLAP tears in middle-aged patients. Primary biceps tenodesis offers increased effectiveness when compared with both primary SLAP repair and nonoperative treatment and lower costs than primary SLAP repair. LEVEL OF EVIDENCE/METHODS:Level III, economic decision analysis.
PMID: 29653794
ISSN: 1526-3231
CID: 3037462
Comparison Between Image-Guided and Landmark-Based Glenohumeral Joint Injections for the Treatment of Adhesive Capsulitis: A Cost-Effectiveness Study
Gyftopoulos, Soterios; Abballe, Valentino; Virk, Mandeep S; Koo, James; Gold, Heather T; Subhas, Naveen
OBJECTIVE:The purpose of this study was to determine the cost-effectiveness of landmark-based and image-guided intraarticular steroid injections for the initial treatment of a population with adhesive capsulitis. MATERIALS AND METHODS/METHODS:A decision analytic model from the health care system perspective over a 6-month time frame for 50-year-old patients with clinical findings consistent with adhesive capsulitis was used to evaluate the incremental cost-effectiveness of three techniques for administering intraarticular steroid to the glenohumeral joint: landmark based (also called blind), ultrasound guided, and fluoroscopy guided. Input data on cost, probability, and utility estimates were obtained through a comprehensive literature search and from expert opinion. The primary effectiveness outcome was quality-adjusted life years (QALY). Costs were estimated in 2017 U.S. dollars. RESULTS:Ultrasound-guided injections were the dominant strategy for the base case, because it was the least expensive ($1280) and most effective (0.4096 QALY) strategy of the three options overall. The model was sensitive to the probabilities of getting the steroid into the joint by means of blind, ultrasound-guided, and fluoroscopy-guided techniques and to the costs of the ultrasound-guided and blind techniques. Two-way sensitivity analyses showed that ultrasound-guided injections were favored over blind and fluoroscopy-guided injections over a range of reasonable probabilities and costs. Probabilistic sensitivity analysis showed that ultrasound-guided injections were cost-effective in 44% of simulations, compared with 34% for blind injections and 22% for fluoroscopy-guided injections and over a wide range of willingness-to-pay thresholds. CONCLUSION/CONCLUSIONS:Ultrasound-guided injections are the most cost-effective option for the initial steroid-based treatment of patients with adhesive capsulitis. Blind and fluoroscopy-guided injections can also be cost-effective when performed by a clinician likely to accurately administer the medication into the correct location.
PMID: 29629805
ISSN: 1546-3141
CID: 3037172