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De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT)
Skolarus, Ted A; Hawley, Sarah T; Wittmann, Daniela A; Forman, Jane; Metreger, Tabitha; Sparks, Jordan B; Zhu, Kevin; Caram, Megan E V; Hollenbeck, Brent K; Makarov, Danil V; Leppert, John T; Shelton, Jeremy B; Shahinian, Vahakn; Srinivasaraghavan, Sriram; Sales, Anne E
BACKGROUND:Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comparative effectiveness trial. METHODS/DESIGN/METHODS:This innovative mixed methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the theoretical domains framework (TDF), urologists and patients from facilities with the highest and lowest castration rates across the VA will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a DCE experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. DISCUSSION/CONCLUSIONS:Our innovative approach to de-implementation strategy development is directly aligned with state-of-the-art complex implementation intervention development and implementation science. This work will broadly advance de-implementation science for low value cancer care, and foster participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through pilot tailoring. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier: NCT03579680 , First Posted July 6, 2018.
PMID: 30486836
ISSN: 1748-5908
CID: 3500642
Variation in National Opioid Prescribing Patterns Following Surgery for Kidney Stones
Leapman, Michael S; DeRycke, Eric; Skanderson, Melissa; Becker, William C; Makarov, Danil V; Gross, Cary P; Driscoll, Mary; Motamedinia, Piruz; Bathulapalli, Harini; Mattocks, Kristin; Brandt, Cynthia A; Haskell, Sally; Bastian, Lori A
Background/UNASSIGNED:Opioid misuse is a significant public health problem. As initial exposures to opioids are frequently encountered through the management of postoperative pain, we examined patterns of opioid prescribing following surgical treatment for nephrolithiasis. Methods/UNASSIGNED:We identified patients with nephrolithiasis in the national Women Veterans Cohort Study (WVCS) who were treated surgically by diagnosis and procedure codes. Using standard conversion factors, we calculated the morphine milligram equivalent (MME) dose prescribed. We used descriptive statistics to characterize opioid prescription across management strategy and multivariable regression to examine clinical and demographic characteristics associated with dispensed dose. Results/UNASSIGNED:We identified 22,609 patients diagnosed with kidney stones during 1999-2014, 1,976 of whom were treated surgically and 1,582 (80.1%) of whom received an opioid prescription. The median age was 39 years, and 1,366 (90%) were male; 1,314 (86.3%) were treated with ureteroscopy, 172 (11.3%) with extracorporeal shockwave lithotripsy, and 36 (2.4%) with percutaneous nephrolithotomy. The median number of days supplied per opioid prescription (interquartile range) was 10 (5-14), and patients were dispensed a median of 180 (140-300) MME. A total of 6.4% of patients received ≥50 MME/d. On multivariable analysis, comorbid diagnosis of post-traumatic stress disorder (PTSD) was associated with higher total dispensed dose, whereas surgery type was not. Conclusions/UNASSIGNED:We observed substantial variation in opioid prescribing following surgical treatment of nephrolithiasis. Although type of surgical intervention did not impact opioid dosing, patients with a diagnosis of PTSD were more likely to receive higher doses. This work can inform efforts to improve the safety and efficacy of postoperative opioid prescribing.
PMID: 30203013
ISSN: 1526-4637
CID: 3277712
Factors Associated With Emergency Department Visits and Hospital Admissions After Invasive Outpatient Procedures in the Veterans Health Administration
Mull, Hillary J; Gellad, Ziad F; Gupta, Rajan T; Valle, Javier A; Makarov, Danil V; Silverman, Tyler; Branch-Elliman, Westyn
PMID: 29801049
ISSN: 2168-6262
CID: 3245992
Burden of Disease for Urethral Stricture Managed by Repeat Endoscopic Treatment vs Single Endoscopic Treatment or Urethroplasty in the Veterans Affairs Population
Rude, Temitope L.; Khurana, Kiranpreet; Yamaguchi, Yuka; Walter, Dawn; Makarov, Danil; Zhao, Lee C.
Introduction: Male urethral stricture disease is a challenging urological condition that affects nearly a third of men 65 years old or older. Management options include dilation and urethrotomy as well as urethroplasty, an open approach with increased morbidity and durability. Presently optimal management remains debated. In this study we focus on emergent procedures required by male patients in the Veterans Health Administration after stricture treatment as an indicator of clinically significant complications, comparing treatment approaches. ISI:000437135000016
ISSN: 2352-0779
CID: 3218132
Use of Conservative Management for Low-Risk Prostate Cancer in the Veterans Affairs Integrated Health Care System From 2005-2015
Loeb, Stacy; Byrne, Nataliya; Makarov, Danil V; Lepor, Herbert; Walter, Dawn
PMCID:6134433
PMID: 29800017
ISSN: 1538-3598
CID: 3165622
Analysis of National Trends in Hospital Acquired Conditions Following Major Urological Surgery Before and After Implementation of the Hospital Acquired Condition Reduction Program,,✰✰✰
Rude, Tope L; Donin, Nicholas M; Cohn, Matthew R; Meeks, William; Gulig, Scott; Patel, Samir N; Wysock, James S; Makarov, Danil V; Bjurlin, Marc A
OBJECTIVE:To define the rates of common Hospital Acquired Conditions (HACs) in patients undergoing major urological surgery over a period of time encompassing the implementation of the Hospital Acquired Condition Reduction program, and to evaluate whether implementation of the HAC reimbursement penalties in 2008 was associated with a change in the rate of HACs. METHODS:Using American College of Surgeons National Surgical Quality Improvement Program (NSQIP) data, we determined rates of HACs in patients undergoing major inpatient urological surgery from 2005 to 2012. Rates were stratified by procedure type and approach (open vs. laparoscopic/robotic). Multivariable logistic regression was used to determine the association between year of surgery and HACs. RESULTS:We identified 39,257 patients undergoing major urological surgery, of whom 2300 (5.9%) had at least one hospital acquired condition. Urinary tract infection (UTI, 2.6%) was the most common, followed by surgical site infection (SSI, 2.5%) and venous thrombotic events (VTE, 0.7%). Multivariable logistic regression analysis demonstrated that open surgical approach, diabetes, congestive heart failure, chronic obstructive pulmonary disease, weight loss, and ASA class were among the variables associated with higher likelihood of HAC. We observed a non-significant secular trend of decreasing rates of HAC from 7.4% to 5.8% HACs during the study period, which encompassed the implementation of the Hospital Acquired Condition Reduction Program. CONCLUSIONS:HACs occurred at a rate of 5.9% after major urological surgery, and are significantly affected by procedure type and patient health status. The rate of HAC appeared unaffected by national reduction program in this cohort. Better understanding of the factors associated with HACs is critical in developing effective reduction programs.
PMID: 29885778
ISSN: 1527-9995
CID: 3155112
Designing a theory-based intervention to improve the guideline-concordant use of imaging to stage incident prostate cancer
Ciprut, Shannon; Sedlander, Erica; Watts, Kara L; Matulewicz, Richard S; Stange, Kurt C; Sherman, Scott E; Makarov, Danil V
Among US men, most new prostate cancer cases are clinically localized and do not require imaging as part of staging workup according to guidelines. Two leading specialty societies promote stewardship of health resources by encouraging guideline-concordant care, thereby limiting inappropriate and obsolete imaging. However, imaging to stage low-risk prostate cancer remains high, as almost half of men with localized prostate cancer undergo wasteful imaging following diagnosis. We employed a theory-based approach, based on current evidence and data on existing practice patterns revealing that providers are the drivers to imaging decisions, to design an intervention to improve guideline -concordant prostate cancer staging imaging across populations. We conceptualized preliminary results using the theoretical domains framework and the behavior change wheel, frameworks used concurrently to investigate physicians' behaviors and intervention design in various clinical settings. Through these 2 frameworks, we designed a theory-based, physician-focused intervention to efficiently encourage guideline-concordant prostate cancer imaging, prostate cancer imaging stewardship (PCIS). Prostate cancer imaging stewardship consists of interventions (clinical order check, academic detailing, and audit and feedback) implemented at the individual, facility, and system level to enact provider behavior change by enabling facilitators and appealing to physician motivation.
PMID: 29398250
ISSN: 1873-2496
CID: 3101102
Automated Pulmonary Embolism Risk Classification and Guideline Adherence for Computed Tomography Pulmonary Angiography Ordering
Koziatek, Christian A; Simon, Emma; Horwitz, Leora I; Makarov, Danil V; Smith, Silas W; Jones, Simon; Gyftopoulos, Soterios; Swartz, Jordan L
BACKGROUND:The assessment of clinical guideline adherence for the evaluation of pulmonary embolism (PE) via computed tomography pulmonary angiography (CTPA) currently requires either labor-intensive, retrospective chart review or prospective collection of PE risk scores at the time of CTPA order. The recording of clinical data in a structured manner in the electronic health record (EHR) may make it possible to automate the calculation of a patient's PE risk classification and determine whether the CTPA order was guideline concordant. OBJECTIVES/OBJECTIVE:The objective of this study was to measure the performance of automated, structured-data-only versions of the Wells and revised Geneva risk scores in emergency department encounters during which a CTPA was ordered. The hypothesis was that such an automated method would classify a patient's PE risk with high accuracy compared to manual chart review. METHODS:We developed automated, structured-data-only versions of the Wells and revised Geneva risk scores to classify 212 emergency department (ED) encounters during which a CTPA was performed as "PE Likely" or "PE Unlikely." We then combined these classifications with D-dimer ordering data to assess each encounter as guideline concordant or discordant. The accuracy of these automated classifications and assessments of guideline concordance were determined by comparing them to classifications and concordance based on the complete Wells and revised Geneva scores derived via abstractor manual chart review. RESULTS:The automatically derived Wells and revised Geneva risk classifications were 91.5% and 92% accurate compared to the manually determined classifications, respectively. There was no statistically significant difference between guideline adherence calculated by the automated scores as compared to manual chart review (Wells: 70.8 vs. 75%, p = 0.33 | Revised Geneva: 65.6 vs. 66%, p = 0.92). CONCLUSION/CONCLUSIONS:The Wells and revised Geneva score risk classifications can be approximated with high accuracy using automated extraction of structured EHR data elements in patients who received a CTPA. Combining these automated scores with D-dimer ordering data allows for the automated assessment of clinical guideline adherence for CTPA ordering in the emergency department, without the burden of manual chart review.
PMCID:6133740
PMID: 29710413
ISSN: 1553-2712
CID: 3056432
The Research Implications of PSA Registry Errors: Data from the Veterans Health Administration
Guo, David P; Thomas, I-Chun; Mittakanti, Harsha R; Shelton, Jeremy B; Makarov, Danil V; Skolarus, Ted A; Cooperberg, Mathew R; Sonn, Geoffrey A; Chung, Benjamin I; Brooks, James D; Leppert, John T
INTRODUCTION/BACKGROUND:We sought to characterize the effects of PSA registry errors on clinical research by comparing cohorts based on cancer registry PSA values with those based directly on results in the electronic health record. METHODS:We defined example cohorts of men with prostate cancer using data from the Veterans Health Administration: those with a PSA values less than 4.0 ng/mL, 4.0 to 10.0 ng/mL, 10.0 to 20.0 ng/mL, and 20.0 to 98.0 ng/mL. We compared the composition of each cohort and overall patient survival when using PSA values from either the VA Central Cancer Registry versus the gold standard electronic health record laboratory file results. RESULTS:There was limited agreement between cohorts defined using either the cancer registry PSA values versus the laboratory file of the electronic health record. The least agreement was seen in patients with PSA values < 4.0 ng/mL (58%) and greatest among patients with PSA values between 4.0 and 10.0 ng/mL (89%). In each cohort, patients assigned to a cohort based only on the cancer registry PSA value had significantly different overall survival when compared with patients assigned based on both the registry and laboratory file PSA values. CONCLUSIONS:Cohorts based exclusively on cancer registry PSA values may have high rates of misclassification that can introduce concerning differences in key characteristics and result in measurable differences in clinical outcomes.
PMID: 29630980
ISSN: 1527-3792
CID: 3037192
The implications of baseline bone health assessment at initiation of androgen deprivation therapy for prostate cancer
Kirk, Peter S; Borza, Tudor; Shahinian, Vahakn B; Caram, Megan E V; Makarov, Danil V; Shelton, Jeremy B; Leppert, John T; Blake, Ryan M; Davis, Jennifer A; Hollenbeck, Brent K; Sales, Anne; Skolarus, Ted A
OBJECTIVES: To assess bone density testing (BDT) use among prostate cancer survivors receiving ADT, and downstream implications for osteoporosis and fracture diagnoses as well as pharmacologic osteoporosis treatment in a national integrated delivery system. METHODS: We identified 17,017 men with prostate cancer who received any ADT between 2005 and 2014 using Veterans Health Administration cancer registry and administrative data. We identified claims for BDT within a 3-year period of ADT initiation. We then used multivariable regression to examine the association between BDT use and incident osteoporosis, fracture, and use of pharmacologic treatment. RESULTS: We found a minority of patients received BDT (n=2,502, 15%), however the rate of testing increased to over 20% by the end of the study period. Men receiving BDT were older at diagnosis and had higher-risk prostate cancer (both p<0.001). Osteoporosis and fracture diagnoses, use of vitamin D +/- calcium, and bisphosphonates were all more common in men who received BDT. After adjustment, BDT, and to a lesser degree, 2 or more years of ADT, were both independently associated with incident osteoporosis, fracture, and osteoporosis treatment. CONCLUSIONS: Bone density testing is rare among prostate cancer patients treated with ADT in this integrated delivery system. However, BDT was associated with substantially increased treatment of osteoporosis indicating an underappreciated burden of osteoporosis among prostate cancer survivors initiating ADT. Optimizing BDT use and osteoporosis management in this at-risk population appears warranted.
PMCID:5878705
PMID: 29124881
ISSN: 1464-410x
CID: 2772902