Lakshmi Santanam, PhD
ACCORDING TO a study by Johns Hopkins, medical errors are the third leading cause of death in the United States.1 Lakshmi Santanam, PhD, tackled such sobering data at the 2018 ASCO Quality Care Symposium. “Incident learning systems are not just about medical errors or data; it’s kind of a first step to understand what went wrong and how to fix it,” said Dr. Santanam, from the Department of Radiation Oncology, Washington University, St. Louis.
To Err Is Human
DR. SANTANAM referenced the groundbreaking National Institute of Medicine report, “To Err Is Human: Building a Safer Health System,” which quantified the alarming number of medical error fatalities in the United States that urged Congress to create a Center for Patient Safety within the Agency for Healthcare Research and Quality.2 How can incident learning systems help prevent medical errors? These systems can be used to identify the local system hazards and collect experiences for uncommon conditions. Moreover, they can be used to share important lessons across organizations, which will enhance patient-safety culture, with safety being the keyword.3
“[Incident learning systems] can be used to share important lessons across organizations, which will enhance a patient-safety culture, with safety being the keyword.”— Lakshmi Santanam, PhD
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Learning from Clinical Trials and Quality Measures
DR. SANTANAM summed up the challenges facing the nation’s clinical trial system: Less than 5% of adult patients with cancer participate in trials, less than 20% of fully able patients enroll in trials, and one-third of Clinical Trials Cooperative Group phase III trials close because of poor accrual.4,5 One of the key things we do is participate in a quality audit program organized by Imaging and Radiation Oncology Core (IROC) Houston, which is operated by the MD Anderson Quality Assurance Center as a requirement for participation in clinical trials. It has close to 2,000 monitoring sites, which distribute tissue density equivalent phantoms.
The radiation team contours the targets and performs treatment planning on the phantoms and then delivers radiation therapy. The treated phantoms are reshipped to IROC Houston, where the treatment delivery is analyzed. They use standardized analysis, which can be compared with other institutions. The results are sent to the users and some sites fail to credential the first time. A retrospective study done by the European group, attributed failure of clinical trials to non-adherence of protocol parameters.6 “You need to figure out why your trial or Quality Audit failed, and that’s where incident learning systems come into play,” said Dr. Santanam.
DR. SANTANAM stressed that medical errors put a huge financial burden on our health-care system. She cited an article from 2012 that concluded medical errors cost our system almost $19.5 billion per year. “However, if you add indirect costs such as the quality of life years into the data, the costs actually rise to almost $1 trillion per year.7 It is vital to learn from these errors, so we can develop strategies to prevent them, as they affect the U.S. economy,” Dr. Santanam added.
Numerous societies offer incident learning systems for a fee, such as the Children’s Hospital Association, the Society for Vascular Surgery, while the American Society for Radiation Oncology/American Association of Physicists in Medicine Radiation Oncology Incident Learning System (RO-ILS) is free. Participating in one of these programs helps you learn from mistakes. A study in Europe looked at the cost of unsafe care vs the cost-effectiveness of implementing patient safety programs. In total, the net benefit of intervention was only €3.67 for a single hospitalization, or almost €300 million for the entire European Union.8
MEDICAL ERRORS, depending on their scope and damage, produce trauma that also affects the personnel involved. Dr. Santanam illustrated how trauma unfolds in various stages by using the well-known incident when Captain Chesley B. “Sully” Sullenberger landed the commercial airplane on the Hudson River. Right after it happened, there was an immediate debriefing during which everyone had to figure out what happened. After that, the trauma set in, and they needed time off. What about the physicians who face the trauma of medical errors? They are the second victims. And it’s important that we help them.9
Dr. Santanam pointed to a study called “Wisdom in Medicine: What Helps Physicians After a Medical Error?” The investigators interviewed 61 physicians who had made serious medical errors. It found that doctors who coped well with medical errors highlight specific ways to help clinicians move through this difficult experience, so they avoid devastating professional outcomes and have the best chance of not just recovery but positive reinforcement as well.10
IN HER CLOSING remarks, Dr. Santanam stated that root-cause analysis of patient safety modeling systems is made incredibly more complicated because the human factor in the equation is very difficult to understand. She stressed that a system’s engineering approach to preventing medical errors is something to consider in the design. “Another key point could be addressed by the value-based payment model. Medicare already understands this model and it will increase patient and workforce safety by encouraging participation in the accountable care organization model.” concluded Dr. Santanam. ■
DISCLOSURE: Dr. Santanam reported no conflicts of interest.
1. Makary MA, Daniel M: Medical error—the third leading cause of death in the US. BMJ 353:i2139, 2016.
2. Institute of Medicine (U.S.) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds: To Err Is Human: Building a Safer Health System. Washington, DC; National Academies Press; 2000.
3. Pham JC, Girard T, Pronovost PJ: What to do with healthcare incident reporting systems. J Public Health Res 2:e27, 2013.
4. Hallquist Viale P: Participation in Cancer Clinical Trials: Researching the Causes of Low Accrual. J Adv Pract Oncol 7:143-144, 2016.
5.Ruckdeschel JC, Albrecht TL, Blanchard C, et al: Communication, accrual to clinical trials, and the physician-patient relationship: Implications for training programs. J. Cancer Educ 11:73-79, 1996.
6. Weber DC, Tomsey M, Melidis C, et al: QA makes a clinical trial stronger: Evidence-based medicine in radiation therapy. Radiother Oncol 105:4-8, 2012.
7. Andel C, Davidow SL, Hollander M, et al: The economics of health care quality and medical errors. J Health Care Finance 39:39-50, 2012.
8. European Commission: Costs of unsafe care and cost effectiveness of patient safety programmes. European Union, 2016. Available at https://ec.europa.eu/ health/sites/health/files/systems_performance_assessment/docs/2016_costs_ psp_en.pdf. Accessed October 18, 2018.
9. Marjorie Podraza Stiegler, M: What I Learned About Adverse Events From Captain Sully. It’s Not What You Think. Available at www.mitemmc.org/uploads/ What-I-learned-from-Capt-Scully-JAMA-2015-1.pdf. Accessed October 26, 2018.
10. Plews-Ogan M, May N, Owens J, et al: Wisdom in medicine: What helps physicians after a medical error? Acad Med 91:233-241, 2016.