Diagnostic Imaging Increasing Effectiveness and Safety

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1 Diagnostic Imaging Increasing Effectiveness and Safety Rebecca Smith-Bindman, MD Professor, Radiology and Biomedical Imaging Epidemiology and Biostatistics Health Policy Obstetrics Gynecology and Reproductive Sciences Director of the Radiology Outcomes Research Lab The University of California San Francisco

2 Diagnostic Imaging Improvements in diagnostic imaging US, CT, MRI, PET have been spectacular Most radiology-based research focuses on the development of new technologies, many of which have clearly had an extraordinary impact on patients Many of these tests are considered among the most important advances in medicine

3 Twin Pregnancies and Twin Twin Transfusion Syndrome (TTTS) 70% of twin pregnancies share a placenta, and there are many different ways two fetuses can share the placenta. One way of sharing the placenta (15%) is called TTTS and is ominous: fetal death in 90% of cases, bad neurologic outcomes Using newly developed techniques on prenatal ultrasound we can identify fetuses with TTTS to identify cases where interventions are possible

4 TTTS Unbalanced Vascular Connections within Shared Placenta

5 Ultrasound Characterizes and Stages Twin Pregnancies as Only Some Need intervention

6 Single port, 3 mm device used to laser vascular connections Once Dx, intraoperative procedure to separate placenta into 2 Team includes pediatric surgery, perinatology, ultrasonography Intra-op ultrasound localizes placenta and cords

8 Laser for TTTS: Outcomes Drastically Improved: 84% of pregnancies with at least one surviving twin

9 Use of Diagnostic Imaging I am a big fan of advanced imaging I am not the only one enamored with imaging everyone is And the use of imaging has soared over the last two decades

10 How Many Patients Undergo CT imaging per Year 1 CT per 5 patients per year 1 CT per 10 patients per year 1 CT per 100 patients per year 1 CT per 500 patients per year

11 Imaging Utilization Among Patients Enrolled in Large Integrated Health Systems Retrospect study, patients enrolled in one of 6 large integrated health care systems, million HMO members each year, followed for 15 years Assessed use of medical Imaging by patient demographics, across modalities and time; also assessed exposure to radiation Smith-Bindman, JAMA, 2012, Trends in Imaging

12 CT Examinations per 1000 HMO enrollees/ year Million CTs Done Annually in US Smith-Bindman, JAMA, 2012, Trends in Imaging

13 Drivers and Costs of Medical Imaging Imaging utilization is high, 100 billion dollars spent annually Its use not always appropriate, and growth twice total health costs Drivers of medical imaging multifactorial Improvement in technology Patient Demand : no perceived disincentives to imaging Physician Demand : testing often easier than seeing patient Fear of malpractice Profitability Increased capacity resulting for a proliferation of equipment

14 Improving the Effectiveness and Safety of Imaging In order to improve how we use imaging we need to understand the use in imaging and its harms, benefits and outcomes Direct evidenced in needed to guide its clinical use when should we use more, when less and when better imaging Research must be collaborative to change practice, bringing together people who order and perform tests and those who pay for them.

15 Outline : Several Examples of Research Variation in imaging utilization a window into where to focus Testing Less Improving imaging one clinical problem at a time: STONE Trial Testing using a different test Reducing the Dose from Imaging: Partnership for DOSE Making the tests we use safer

16 Hospital Based Imaging Accounts for roughly half of all imaging UCSF is trying to figure out how to cut costs, and I am involved in efforts to improve the use of radiology The UHC (University Health System Consortium) is a a collaboration across University medical centers to share data I wanted to look at the variation in imaging rates across institutions to help identify good target areas clinical service lines, patient groups with opportunities to use imaging more wisely

17 EPI Rad : Evidence Based Practice Improvement in Radiology Preliminary results! As pilot selected 25 comparable hospitals from UHC list Assessed use of imaging in patients within narrowly defined MS- DRG groups For each diagnostic group, we assessed proportion of patients who underwent advanced imaging using CT,MRI, PET, US, or any of these test, during admission or proceeding 72 hours. Summarized results across all admission categories and will weight by standardized distribution of DRGs

18 Financial Implications of Variation UHC has developed resource intensity weights for individual resources, including imaging (by CPT code) This resource intensity weight is nonmonetary metric based on ambulatory payment classification weights from CMS, but is then assigned a $$ Each imaging exam is assigned a relative value unit and cost US Abdomen RVU 1.9 $135 CT Abdomen RVU 5.3 $390 MRI Abdomen RVU 5.9 $426

19 Previous example focusing on using variation to identify areas in which to target and understanding cost implications of care patterns Next example focuses on how to decide what is the right test to do

20 Imaging of Patients with Suspected Kidney Stones Pain from a kidney stone accounts for > 1 million ED visits/yr Since the mid 1990s CT has become the primary test Its greater accuracy, 24-7 availability led to universal adoption Despite a 10 fold increase in the use of CT scans over 20 years, there has been no demonstrated improvement in patient outcomes (stone dx, alternative dx, hospitalizations, etc) stones

21 Potential Benefits and Harms of CT (versus US) Benefits Greater Accuracy Harms Radiation Exposure Doses in Carcinogenic Range False Positive Results /Incidental findings Cascade of testing Over Diagnosis: Leads to unnecessary Rx Contrast Reactions Costs

22 Study of Tomography of Nephrolithiasis Evaluation 15-center randomized pragmatic comparative effectiveness trial comparing initial imaging with ultrasound versus CT (AHRQ) Patients were randomized to one of three study arms [point-of-care ultrasound by ED physicians; radiology ultrasound and CT] and followed for 6 months where a broad range of outcomes were assessed Smith-Bindman, NEJM,2014

23 Participating Academic Centers ED physician, radiologist, urologist collaborators identified at each site

24 Study Inclusion Criteria Adults ages Non obese (weight < 285 lbs men, < 250 lbs women) High risk for kidney stone (based on estimate of MD) Low risk of alternative diagnosis (based on estimate of MD) 2759 patients enrolled, randomized, included

Study Outcomes: Measurements that Matte Primary Outcomes High risk diagnosis with complications Radiation Exposure Costs Secondary Outcomes Serious Adverse Events (dx, hospital

25 Study Outcomes: Measurements that Matte Primary Outcomes High risk diagnosis with complications Radiation Exposure Costs Secondary Outcomes Serious Adverse Events (dx, hospital admit, etc.) Related SAE (judged by 2 to be possibly related to trial) Hospital readmission, ED readmission Pain scores Diagnostic Accuracy Patients contacted at 3, 7, 30, 90, 180 days

26 Study Results There were no differences in baseline characteristics across arms There were no differences in clinical outcomes High risk diagnoses with complications Related and total serious adverse events ED length of stay, hospital admissions and readmits, Pain scores over time Accuracy for diagnosis Emergency department and radiology ultrasound similar Smith-Bindman, NEJM,2014

27 STONE Trial: Two Significant Differences The patients in the CT arm are received twice as much radiation The costs for patients in the CT arm were higher Around 1/3 of patients initially assigned to ultrasound ended up with a CT (allowed in trial), yet despite this duplicative testing, radiation exposure and costs still lower in the US arms

28 Conclusion: Evaluation of Patients with Suspected Stones Ultrasound should be the first test Ultrasound can be performed by whomever has expertise The results are being rapidly embraced by ED physicians Among some patients, POC US reduced stay in ED by an hour There are 40 ongoing analysis using these data to assess a range of outcomes related to an initial choice of imaging, being led by radiologists, urologists, ED physicians and epidemiologists Relying on accuracy statistics to demonstrated that a test is better is not sufficient to predict associated patient outcomes and really should not drive practice or payment

29 Improving the Performance of Tests

30 Medical Radiation: An Important Safety Issue Most imaging tests use ionizing radiation: a known carcinogen x-rays, CT, nuclear medicine, fluroscopy, angiography (not US or MRI) Doses for CT are higher than conventional x-rays (500 xs higher) The higher use of CT, resulted in a 6 x increase in medical radiation exposure and doubling of total exposure last 15 yrs Further, the doses are far higher than needed for diagnosis and highly variable across institutions To lower patients exposure to radiation, need to lower use of imaging and do imaging using less radiation

31 What Are the Doses Used for CT? I have collaborated on several studies assessing CT doses Studies were unusual in that we looked at actual doses to patients, rather than estimates from phantoms, and organized the results by the reason for imaging We have found that the doses for CT are high and highly variable, varying tremendously for patients imaged for the same reason JAMA Internal Medicine 2009; JAMA 2012, JAMA Pediatrics 2013

32 Variation in Dose : 4 Hospitals San Francisco Bay Area Mean Effective Dose (msv) Head Hosp A Hosp B Hosp C Hosp D Suspected Stroke Chest Suspect Cancer Suspected PE Abdomen Pain Suspect AAA JAMA Internal Medicine 2009

33 Radiation Doses in Children Six integrated healthcare systems in the US Children under 15 years We abstracted detailed data for random sample of exams Doses varied 50 fold between patients Miglioretti, JAMA Pediatrics,

34 Stone Trial Results Optimum Low Dose Protocol Smith-Bindman, JAMA IM, 2015

Doses Variation Variation in Doses used for CT imaging Is

more complicated Stone trial the clinical need was the

pain Many decisions are made about what test to do, how to

35 Doses Variation Variation in Doses used for CT imaging Is profound Its often assumed patient need drives the doses : more complicated Stone trial the clinical need was the same but doses were not Patient with symptoms i.e. flank pain Many decisions are made about what test to do, how to do that test Resulting Scan reflects much more than patient need

36 Why Are Doses so Variable? No comprehensive standards or guidelines on CT - there is the sense that everyone should be free to choose Doses should be as low as reasonably achievable -ALARA, but there are few guidelines for what doses are reasonable or achievable In the absence of explicit guidelines, practice variation introduces unnecessary harm from excessive radiation Each MD trying to keep to ALARA is not a strategy No organization responsible for collecting dose data

37 How To Standardize Dose Manufacturers are developing hardware / software solutions but will take decades to replace current scanners Need to move forward on improving the safety of imaging before these solutions are available Need to Assess Doses Create Benchmarks Develop Strategies to Meet Benchmarks Create incentives for radiologists to meet benchmarks (policy)

38 UCDOSE Collaboration across 5 University of California Medical Centers Medical physicists, radiologists, technologists, biostatisticians Primary goal was to pool data across campuses, used these data to describe and improve practice. Comply with new state law requiring reporting of dose in electronic records Project funded by University of California Office of the President

39 Analysis of Pooled Data We found substantial variation in radiation doses We explored the the data to understand variation While some variation could be explained by patient and scanner factors, most of the variation was due to differences by campus in how they liked to do CT (i.e. personal preferences without clear evidence)

Chest and Abdomen CT Dose Across 5 UC Health Systems 35 30

40 Chest and Abdomen CT Dose Across 5 UC Health Systems Median Effective Dose (msv)

41 Using Results to Drive Practice We convened an in-person meeting and invited the section heads from neuro, body, and chest; technologists; physicists; researchers to participate Each site was provided with their doses ahead of time and Webex calls were had before and after meeting to review results Section heads were asked to come prepared to explain, defend, or change practice We Identified areas where dose reduction was possible Concrete lists of changes to be made were created at meeting

42 Abdomen Radiation Doses 2014 (Effective Dose)

43 Abdomen Radiation Doses 2014 (Effective Dose)

44 Computed Tomography (CT): What is the Problem? The doses used for CT are far higher than conventional x-rays The doses are far higher than needed for diagnosis These doses are in the range that they will cause cancer in a small, but significant number of people (we need to quantify this better) The doses are highly variable across institutions While higher dose can lead to more detailed images, there is no evidence that these lead to more accurate diagnosis There are few standards- benchmarks- for what is the right dose

45 Why Are Doses so Variable No comprehensive standards or guidelines on CT - there is the sense that everyone should be free to choose Guiding principal is that doses should be as low as reasonably achievable -ALARA - but there are few guidelines for what doses are reasonable or achievable In the absence of explicit guidelines, practice variation introduces unnecessary harm from excessive radiation ALARA does not work No organization responsible for collecting or compiling dose data

46 Legislative Oversight on Imaging The only imaging test with oversight by law is mammography National mammography legislation the Mammography Quality Standard Act oversees the conduct of mammography in every US facility Radiation doses (in addition to many other aspects) are regulated The quality of mammography improved profoundly with the passage of the MQSA No meaningful oversight exists for CT

47 How To Optimize Dose Manufacturers are developing hardware / software solutions but it will take decades to replace current scanners Dose monitoring software can help facilities know about their dose and is a good start, but not enough to ensure safety by itself Hospitals and imaging facilities must Assess their doses Compare with benchmarks Develop strategies to meet benchmarks Ensure education of staff for QI Repeat

48 Why Do you Need a Strategy What Steps Lead to the Doses Patients Receive Test is ordered (ED) with various levels of detail (choices) Test is protocoled (by tech, md, other) to call for particular study Protocols are preloaded onto CT machine (physicist, tech, manuf) Technologist chooses the protocol on the machine to correspond with request Technologist tweaks or alters protocol Exam reviewed, and possibly repeated or augmented

49 What Do We Do at UCSF to Monitor Dose We review high doses (by patient) and average doses (for groups of patients) on a monthly basis, by machine, anatomic area, protocol and age group using Radimetrics At monthly radiology safety meetings, trainees, attending physicians, technologists review outliers, discuss and investigate The technologists review each high dose cases and try to figure out why particular patient s dose are higher than expected and as a team we brain storm solutions We compare the data to benchmarks Our doses continue to come down!

50 NIH and PCORI : CT DOSE Collaboration 5 year study Academic and non-academic medical centers, US and non-us Expands on previous work Create broader dose benchmarks Understand facility characteristics, change culture, Study what works and what does not to optimize Study design based on using a randomized controlled design Doses are pooled from over 100 institutions

51 Collaborating Institutions UCSF UC Davis UC San Diego Health Partners Institute University of Duisburg-Essen Oxford University Hospitals NHS University Hospital of Basel National Health Services Scotland Maastricht University Med Center St. Luke's Hospital, Tokyo Assuta Health, Israel 1-40 hospitals / Institution Center for Diagnostic Imaging San Francisco Veterans Affairs City of Hope Henry Ford Health System St. Joseph Health System Mount Sinai School of Medicine Miami Children's Hospital Emory Health System University of Virginia Children's Mercy Hospitals Huntsville Hospital System Olive View - UCLA Einstein Healthcare Network Community Health Network Maricopa Integrated Health East Texas Health Centers

52 NIH Aim 1 RCT to compare Audit vs. Multicomponent Intervention Audit provide sites feedback on how they compare Multicomponent Intervention More tailored, site-specific audit feedback Tailored suggestions for lowering doses Meetings with project Change team and hospitalcreated Implementation Teams Collaborative quality improvement meetings Education on how to created a local quality improvement team and how to do CQI

53 NIH Aim 2 Assess implementation and identify facilitators, barriers, and strategies associated with implementation of dose optimization and sustained dose improvements Institutional leaderships views will be assessed Priority to improve radiation safety CT dose optimization Organizational readiness to make changes Care processes and systems associated with successful implementation Asses the association between facility factors and dose

54 NIH Aim 3 Broadly expand our work dissemination and implementation Our hope in years 4 and 5 of the project is to allow and encourage all institutions who conduct CT to participate in our registry, and get audit information, and get feedback that we have found to be most effective in our study.

55 Current Status of Project Registry is established, CT doses are flowing into the registry, > 2 million scans; 20,000 CTs added weekly We are finalizing our audit reports We are finalizing our multicomponent intervention We will begin our feedback in 2016, and assess the relationship between feedback and optimization We are hoping to create a publically accessible website of doses/protocols

56 Communicating with Patients The idea of sharing results directly with patients is not new Work is needed to make imaging results and specifically radiation information accessible and understandable We just received a small PCORI grant to speak with patients about what they want to know about imaging; how to communicate these results with patients including radiation in a way that educates them without frightening them; and to share these data on a website We want to encourage patients and hospitals/providers to Know Your Dose

57 What Should What Be Should Communicated be Communicated about CT Risk / Dose Nothing Organ Specific Dose Detailed Cancer Risks Comments at US Congressional Hearing on Radiation, 2010 It is the radiologist job ensure safety we don t want to frighten patients The risk of radiation injury from a CT scan is virtually non-existent Comments from recent Radiology editorial 2015 We don t know if radiation is harmful or protective, so if we discuss with our patients, we need to tell them both are possible We have a long way to go to improve communication

58 Impact of Reducing the Highest Doses in Children Miglioretti, JAMA Pediatrics, 2013 Our study of doses in children ages 15 and younger included a very number of children: 4.8 million patient-years Over 10 % of children received doses for single scan that the UK authors showed tripled their risk of cancer We estimate that national use of CT in children in 2010 will result in 9,820 future cancers. Reducing the highest outlier doses to the average to the median would prevent 44% of these cancers.

59 Conclusion Improving imaging utilization and how imaging is done can have a very positive impact on patient outcomes, costs and patient satisfaction Because imaging cuts across so many disciplines there are extraordinary opportunities for research but it must be collaborative to be useful There is growing interest from funders in the imaging You need training, but with appropriate training the possibilities for a successful career are nearly limitless

created by high-voltage devices Examples include medical and dental x-rays, light, microwaves and nuclear energy

created by high-voltage devices Examples include medical and dental x-rays, light, microwaves and nuclear energy What is radiation? Radiation is energy emitted from a source, that travels through space and can penetrate matter. Listed below are two types that we are exposed to and contribute to our overall radiation