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Special Report Quality of Care of Patients With Non–Small-Cell Lung Cancer: A Report of a Performance Improvement Initiative Fred R. Hirsch, MD, PhD, Robert M. Jotte, MD, PhD, Carolyn A. Berry, PhD, William A. Mencia, MD, Stephanie A. Stowell, MPhil, and Allison J. Gardner, PhD Background: Lung cancer is the leading cause of cancer deaths in the United States. In recent years, significant advancements have been made in the molecular characterization of tumors, and the availability of new agents to treat non–small-cell lung cancer has increased. Despite these achievements, optimal care of patients with this condition remains less than ideal. Although national quality measures and guideline recommendations provide the necessary framework for patient care, routine self-assessment of adherence to these measures is required for physician practice improvement. To this end, a performance improvement initiative that met national continuing medical education standards was designed. Methods: Focusing on non–small-cell lung cancer patient care, oncologists underwent a three-step process that included a self-assessment of predetermined performance measures, the development and implementation of an actionable plan for improvement, and a second round of assessment to measure practice change. Results: A total of 440 unique patient charts were reviewed by 22 practicing oncologists. Participants demonstrated high baseline performance levels of established quality measures, such as inclusion of the patient’s pathology report and assessment of smoking history. Significant gains were observed in the areas of supportive care, including assessment of the patient’s emotional well-being and the use of molecular markers in diagnostic and treatment decision making. Conclusions: Data from this study support the value of performance improvement initiatives to help increase physician delivery of evidence-based care to patients. Introduction Lung cancer is highly prevalent and often fatal. More than 225,000 new cases are diagnosed each year in the United States, 85% to 90% of which are non–smallcell lung cancer (NSCLC).1 Lung cancer is the leading cause of cancer-related mortality, accounting for approximately 28% of cancer-related deaths.1,2 Contributing to the poor prognosis of lung cancer is the fact that it often goes undetected until it has progressed to advanced-stage disease.1 In addition to the high prevalence of NSCLC, contemporary management is becoming increasingly complex due to the identification of key biomarkers that influence optimal treatment selection and the development of targeted therapies. Appropriate patient care also requires the coordination of oncologists, From the University of Colorado Cancer Center (FRH), Aurora, CO, Rocky Mountain Cancer Centers (RMJ), Denver, CO, Langone School of Medicine (CAB) at the New York University, New York, NY, and Med-IQ (WAM, SAS, AJG), Baltimore, MD. Submitted May 8, 2012; accepted January 9, 2013. Address correspondence to Stephanie A. Stowell, MPhil, Med-IQ, 5523 Research Park Drive, Suite 210, Baltimore, MD 21228. E-mail: [email protected] This initiative was supported by an unrestricted educational grant from Lilly USA, LLC. The funding source had no role in the execution, analysis, or development of the resulting manuscript associated with this initiative. 90 Cancer Control pathologists, nurses, and other specialists. Given these factors, efforts focusing on enhancing quality patient care are necessary to improve clinical outcomes and reduce the human and financial toll of lung cancer. The development and implementation of qualitybased performance measures have the potential to improve outcomes for patients with cancer. Practicebased education that integrates measures focusing on specific clinical decisions and processes can provide a more personalized approach to improving knowledge when compared with more traditional educational platforms. Through the use of self-assessments, clinicians are provided a realistic view of their practices, which allows for more conscientious efforts to align behavioral and systems-related goals. Quality improvement in oncology has been a growing focus of attention over the last 15 years. The National Cancer Policy Board (NCPB) was established by the Institute of Medicine and the National Research Council in an effort to assess the quality of cancer prevention, control, diagnosis, treatment, and palliation.3 In an ensuing report, the NCPB concluded that wide disparities exist in the quality of cancer care in the United States, thereby highlighting the need for performance measures to improve clinical outcomes.4 The American Society of Clinical Oncology (ASCO) responded to this call for quality improvement by deJanuary 2014, Vol. 21, No. 1 veloping the National Initiative on Cancer Care Quality (NICCQ) in 2000. In 2002, the Quality Oncology Practice Initiative (QOPI) was designed as a quality improvement program specifically for ASCO members.5-8 These programs initially focused on two of the most prevalent cancers in the United States — breast and colorectal cancers — and established a model for the comprehensive assessment of community oncologist practice patterns, which has since been expanded to address multiple cancer types, including NSCLC. In addition to these programs, the American Board of Medical Specialties and the American Medical Association (AMA)–convened Physician Consortium for Performance Improvement created validated performance measures and developed a nationally standardized continuing medical education (CME) format to improve patient care.9,10 Specifically, AMA performance improvement (PI) is a nationally standardized CME model that allows participants to earn up to 20 AMA Physician’s Recognition Award category 1 credits™ through the completion of a 3-step process of selfassessment, improvement, and reassessment. Informed by existing lung cancer performance measures, current evidence-based NSCLC treatment guidelines, and previous experience in designing a PI initiative focused on colorectal cancer care, an Accreditation Council for Continuing Medical Education–accredited provider of CME collaborated with 2 expert lung cancer faculty members to develop a complementary, first-of-its-kind NSCLC-specific PI initiative for community oncologists.11 Using the performance measures as a tool to evaluate practice patterns, participating oncologists assessed the quality of patient care delivered at baseline, formulated and applied a PI strategy specific to the needs of their practice, and reevaluated the quality of patient care following this period of improvement to optimize the implementation of evidence-based practice patterns and, ultimately, outcomes for patients with NSCLC. Methods Process of AMA PI The NSCLC PI initiative was structured according to the standardized AMA PI CME model.9 Prior to entering stage A, participants completed a self-assessment questionnaire addressing current practice processes and procedures. This was used as a means to prompt participants to reflect on potential areas of educational need and facilitate the development of a meaningful improvement plan. In stage A, participants conducted a self-assessment based on a set of predetermined performance measures through a retrospective review of eligible patient charts. These performance measures focused on key processes of care, such as diagnostic procedures, staging, supportive care, and evidence-based treatment decisions. Individuals’ pracJanuary 2014, Vol. 21, No. 1 tice patterns were compared with those of their peers participating in the initiative and clinical guideline recommendations, when applicable. The results of this self-evaluation process served as the basis for the development of an individualized plan for improving practice performance in the second step (stage B) of the initiative. Participants implemented their individual plans over a period of active improvement. During this time, participants accessed a CME-certified publication, which provided a comprehensive review of evidence-based NSCLC management strategies and the clinical data supporting these recommendations, as well as applicable tools designed to aid in PI (eg, a staging checklist, a patient distress thermometer and checklist, an algorithm for the first-line treatment of advanced NSCLC). At the end of the active period of improvement, participants entered the final step of the initiative (stage C), in which they conducted a second round of self-evaluation using unique charts from patients whose disease had been diagnosed during each participant’s period of active improvement. Each participant’s performance in stage C was subsequently compared with his or her own baseline performance in stage A, the performance of their peers in stage C, and national standards, as applicable. Performance Measure Selection Performance measures for this PI initiative were developed based on the NSCLC-specific measures included in the ASCO QOPI program, as well as national evidence-based guideline recommendations for quality patient care in NSCLC, and reflected best practices for the management of all stages of NSCLC at the time of initiative planning (November 2009; Table 1).12-22 The majority of the performance measures were worded such that responses could be coded in simple terms of “yes,” “no,” or “N/A” (not applicable) and were assessed for ease of abstraction from medical oncology records. Medical Record Selection Each participant was asked to submit information from the charts of 10 patients with a primary diagnosis of NSCLC in stages A and C, for a total of 20 charts. Patients who had been diagnosed with NSCLC within 1 year of the last office visit were eligible, and patients with any stage small-cell lung cancer or non-primary lung tumors were excluded. Participants were instructed to review different patient charts in stage A and stage C; therefore, data were considered to be unlinked. Confidentiality and Exemption From Consent Institutional review board approval was not sought for this initiative. According to the US Department of Health and Human Services, research is exempt from Cancer Control 91 institutional review board evaluation if the research involves the collection or study of existing data, documents, and records and “if the information is recorded by the investigator in such a manner that the subjects cannot be identified directly, or through identifiers linked to the subjects.”23 To ensure compliance with these requirements, patient data were collected in a de-identified format. Table 1. — Evidence-Based Performance Measures Statistical Analysis Analyses were conducted at the patient chart level. Responses to individual questions that were marked as “N/A” or unanswered were omitted from the analysis. Pearson’s chi-square tests were used to compare individual performance measures between stage A and stage C unless otherwise noted. When statistically appropriate, Wilcoxon rank-sum and Fisher 2-tailed exact tests of significance were used. Results were considered statistically significant if the resulting probability value was less than .05. Evaluation and Staging Imaging techniques ordered for clinical staging of patient with suspected lung cancer Head CT or MRI brain imaging performed for patients with stage III or IV disease Copy of surgical pathology report included in patient’s chart Number of lymph nodes resected for patients with stage I, II, or IIIA disease who underwent surgery Referral for surgical evaluation documented for patients with stage I, II, or IIIA disease who did not undergo surgery Core biopsy or bronchoscopy performed if surgery was not performed Histological confirmation of isolated metastatic disease documented for appropriate patients Proper stage assigned per the 7th edition of the IASLC TNM Classification of Malignant Tumors based on pathology results Further tumor characterization sought for specimens designated “NSCLC NOS” Performance status assessed and documented at the time of diagnosis Performance status assessed and documented at the last office visit Surveillance and Supportive Care Follow-up chest CT scan performed within 6 months after surgery for patients with nonmetastatic disease who underwent surgical resection Smoking history established and documented Current smoking status documented at the last office visit Smoking cessation counseling recommended and documented for active smokers Cancer-related distress (ie, psychological, social, spiritual) documented Treatment Adjuvant chemotherapy recommended for patients with stage IA disease (overuse measure) Adjuvant chemotherapy recommended for patients with stage IB disease Adjuvant chemotherapy recommended for patients with resectable stage II or III disease Reason documented if a patient with resectable stage II or III disease received adjuvant chemotherapy that was not cisplatin-based Nonsquamous cell histology documented for patients with unresectable stage III or IV disease who received bevacizumab or pemetrexed EGFR and/or KRAS mutation testing performed prior to treatment for patients with advanced adenocarcinoma who received an EGFR TKI Concurrent chemoradiation recommended for patients with unresectable stage III disease and good performance status Immediate course of maintenance treatment recommended for patients with advanced NSCLC who were in remission or had stable disease after completion of first-line therapy Data were derived from references 12-22. CT = computed tomography, EGFR = epidermal growth factor receptor, IASLC = International Association for the Study of Lung Cancer, MRI = magnetic resonance imaging, NOS = not otherwise specified, NSCLC = non–small-cell lung cancer, TKI = tyrosine kinase inhibitor, TNM = tumor, node, metastasis. 92 Cancer Control Results Participant Demographics A total of 22 physicians completed the PI initiative between January 2010 and August 2011. Demographic information for this group is presented in Table 2. Forty-one percent of participants reported practicing in a group setting, and nearly one-quarter reported practicing in a community-based oncology center. Most physicians had been practicing between 6 and 10 years. The average number of patients with NSCLC who were reported to be seen each month by participants was 25 (range, 2–75), approximately 5 of whom were presenting for a first visit (range, 1–25). Patient Demographics A total of 440 patient charts were submitted by PI participants: 220 in stage A and 220 in stage C. Most of Table 2. — Participant Demographics (N = 22) Practice Type Academic medical center Community-based oncology center Community-based hospital Group practice Solo practice Other 14% 23% 14% 41% 5% 5% Years in Practice <1 1–5 6–10 11–20 > 20 0% 14% 36% 27% 23% Average number of patients with NSCLC (per month) 25 Average number of first-visit patients with NSCLC (per month) 5 NSCLC = non–small-cell lung cancer. Because of rounding, percentages do not total 100. January 2014, Vol. 21, No. 1 Table 3. — Patient Cancer Staging According to Participant Performance Improvement Stage Performance Improvement Cancer Stage Stage A n (%)a Stage C n (%) I 45 (20) 49 (22) II 23 (10) 43 (20) III 67 (30) 50 (23) IV 85 (39) 78 (35) a Because of rounding, percentage does not total 100. the patients with NSCLC whose charts were reviewed as part of this initiative were classified as having stage III or IV disease (Table 3). smoking history was nearly universally established for all patients upon diagnosis, rates of performing routine reassessment of current smoking status and incorporating recommendations for smoking cessation counseling were less than ideal in stage A. After completing the PI process, the percentage of participants who documented a patient’s current smoking status increased from 89% to 99% (P < .001), and the percentage of those who referred current smokers to cessation counseling increased from 86% to 98% (P = .001; Fig 2). Participants assessed emotional wellbeing and cancer-related distress in 90% of their patients in stage C, representing a 30% increase over baseline from stage A (P < .001). With regard to evidence-based treatment measures, notable changes in clinician performance were observed (Fig 3). The documentation of nonsquamous histology in the charts of patients with unresectable stage III or IV disease who were treated with bevacizumab or pemetrexed significantly increased from 83% to 99% upon completion of the activity (P = .002). EGFR mutation testing was also more likely to be performed on patients with advanced adenocarcinoma prior to treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (48% in stage A to 88% in stage C; P < .001). A total of 88% of patients who had advanced NSCLC and stable disease immediately following the completion of first-line therapy were offered maintenance therapy in stage C, an increase of 19% from the stage A baseline level (P = .007). No. of Patients (%) Performance Gains Several significant improvements were observed in the staging and characterization of NSCLC at the conclusion of the activity. Participants were more likely to use chest radiography in addition to computed tomography scans of the chest and 18F-fluorodeoxyglucose–positron emission tomography scans to aid in the clinical staging of patients with suspected lung cancer (50% to 74% from stage A to stage C, respectively; P < .001). Although surgical pathology reports, including proper stage assignment according to the seventh edition of the International Association for the Study of Lung Cancer (IASLC) Tumor Node Metastasis (TNM) Classification of Malignant Tumors, were inStage A Stage C cluded with 100% of the patient charts in both stages A and C 100 (data not shown), the proportion of participants who sought 90 further characterization of tumors designated to be NSCLC not otherwise specified (“NOS”) 80 increased from 78% in stage A to 92% in stage C (P = .028; Fig 1). 70 In addition, multiple aspects of patient evaluation improved over the course of the PI process 60 (Fig 1). Despite a high baseline level in the assessment of per50 formance status at the time of diagnosis and at the last office 40 visit, significant improvement Chest Further PS at PS at was observed in stage C for Radiography Characterization Diagnosis Last Visit both measures (performance of NOS status at diagnosis: 96% in stage n = 220 n = 220 n = 64 n = 63 n = 220 n = 220 n = 187 n = 188 A to 99% in stage C, P = .033; performance status at the last Fig 1. — Participant performance gains from stages A to C. Chest radiograph order for clinical staging, P < .001. Further characterization of NSCLC tumors designated “not otherwise stated” (NOS), P = .028. visit: 80% in stage A to 100% Performance status (PS) assessed at the time of diagnosis, P = .033. PS assessed at the last office visit of in stage C, P < .001). Although patients with at least 1 office visit, P < .001. January 2014, Vol. 21, No. 1 Cancer Control 93 Discussion initial self-evaluation and engagement in a period of planned improvement, participant data revealed a significant improvement in the incorporation of histological and genetic features into management decisions for appropriate patients. Research published in the last 7 years has illustrated the Stage A Stage C key role of histology in deter100 mining optimal treatment courses for advanced NSCLC. Recent evidence suggests that histologi90 cal subtype is related to median survival, drug toxicities, and the potential for specific genetic 80 abnormalities.24-26 For instance, patients with squamous cell car70 cinoma have an increased risk of bleeding and are more likely to experience life-threatening 60 or fatal hemoptysis if treated with bevacizumab, and clinical 50 evidence fails to demonstrate a significant therapeutic benefit with pemetrexed in this subset 40 of NSCLC patients.27,28 FurtherEmotional Current Smoking Smoking Well-Being History Smoking Status Cessation more, neither agent is approved n = 220 n = 220 n = 220 n = 220 n = 134 n = 151 n = 110 n = 108 by the US Food and Drug Administration (FDA) for use in Fig 2. — Participant performance gains from stages A to C. Assessment of emotional well-being, P < .001; patients with this histological smoking history, P = 1.000; current smoking status of active smokers, P < .001; smoking cessation counseling recommended to active smokers, P = .001. subtype. However, patients with nonsquamous pathology who receive these therapies are more likely to respond to Stage A Stage C treatment and avoid potentially 100 fatal adverse events. Therefore, accurate tumor subtyping and 90 effective communication between oncologists and pathologists are essential components 80 of high-quality care of patients with NSCLC.21,22,29 70 At the completion of this activity, oncologists more proactively pursued “NOS” pathology 60 designations to discern more specific tumor characteristics; since 50 accurate tumor subtyping can guide therapeutic decisions and prevent inappropriate treatment 40 choices for this patient populaMaintenance Nonsquamous EGFR Therapy Histology Mutation Testing tion, this improvement may have n = 74 n = 66 n = 220 n = 220 n = 46 n = 33 a clinically relevant impact. In addition, the appropriate use of Fig 3. — Participant performance gains from stages A to C. Nonsquamous cell histology documented for proven treatment regimens in patients with resectable stage III or IV disease who received bevacizumab or pemetrexed, P =.002; EGFR patients with unresectable stage and/or mutation testing performed prior to treatment, P < .001; maintenance therapy recommended for patients with advanced NSCLC in remission or with stable disease after first-line therapy, P = .007. III or stage IV disease with docuNo. of Patients (%) No. of Patients (%) This NSCLC-focused PI initiative demonstrated that oncologists can improve clinical skills relevant to the evaluation, staging, supportive care, and evidencebased treatment of patients with NSCLC. After an 94 Cancer Control January 2014, Vol. 21, No. 1 mented nonsquamous cell histology increased among physicians participating in this initiative. Clinical advancements surrounding key molecular biomarkers and the development of targeted therapies are also of particular importance to the management of NSCLC because it is estimated that more than one-half of these tumors have an identifiable mutation.30 Data from several trials, including the IRESSA Pan-Asia Study, First-SIGNAL, OPTIMAL, EURTAC, and those from the North-East Japan and West Japan Study Groups, demonstrate that newly diagnosed patients with advanced-stage NSCLC and a known EGFRactivating tyrosine kinase domain mutation may benefit from first-line targeted chemotherapy.31-36 Prompted by clinical evidence that supports the importance of determining EGFR mutation status on optimal treatment decisions, the FDA formally approved erlotinib for the first-line treatment of patients with metastatic NSCLC and exon 19 deletions or exon 21 L858R substitution mutations in the EGFR gene as determined by a companion diagnostic test in May 2013.37 In addition, ASCO and the National Comprehensive Cancer Network (NCCN) updated their NSCLC clinical practice guidelines to formally incorporate into treatment recommendations this new indication as well as data from studies examining novel targeted agents directed against tumors harboring anaplastic lymphoma kinase (ALK) gene rearrangements.29,34,38-40 The PI initiative was developed before the ALK-specific inhibitor became available outside of a clinical trial, so evaluation of the ALK gene rearrangement was not included as a performance measure in this activity. However, EGFR mutation testing for appropriate patients increased by 40% from baseline level; because mutation testing results are poised to guide the selection of individualized treatment strategies that have the maximal impact on disease progression and patient survival rates, this 40% improvement is of clinical significance. Another noted change regarding evidenced-based treatment performance among PI participants was the increase in the recommendation of maintenance therapy for patients with advanced disease. Maintenance therapy is a relatively new concept in NSCLC, and it has been a subject of intensive clinical investigation and controversy over the last decade. When the PI activity was launched in January 2010, only pemetrexed and bevacizumab (if initially given with chemotherapy) were recommended by guidelines from the NCCN for maintenance therapy in patients with tumor response or stable disease after first-line therapy.14 However, based on the results of multiple large-scale trials with various maintenance protocols that have illustrated significant improvements in progression-free survival, and overall survival rates to a lesser extent, guidelines from both ASCO and the NCCN expanded treatment options and added additional agents in this setting, includJanuary 2014, Vol. 21, No. 1 ing erlotinib, cetuximab, and gemcitabine.22,24,29,37,41-43 This approach exemplifies a shift in care for patients with cancer. Although evidence is still accumulating regarding the exact benefits and limitations of maintenance therapy, more oncologists are considering this therapeutic strategy for select patient populations. In the area of supportive care, physician participants were 30% more likely to assess cancer-related distress in patients during stage C of the PI activity. Increasingly, emotional well-being is recognized as an essential component of care for patients with cancer.44 Evidence suggests that up to 40% of patients with cancer experience significant distress associated with their disease; however, estimates of the proportion of these patients who receive or are referred to counseling or psychological treatment are low, ranging from 10% to 50%.44-46 The need for recognition of psychological distress is of particular importance to busy, community-based oncology practitioners, for whom psychosocial resources may be limited.44 To address suboptimal identification and management of emotional and psychological distress among patients in oncology clinics, the Commission on Cancer introduced a new performance standard requiring psychosocial distress screening to be performed at pivotal time points, such as diagnosis and treatment transitions, and will require physicians to document provision of psychosocial care and follow-up of identified individuals.47 As more standards concerning patient emotional well-being are adopted, oncologists will need to expand their competencies to include the varying aspects of psychosocial care. In addition to increased awareness of psychological distress, physician participants improved the regular reassessment of their patients’ smoking status and recommendation of cessation counseling to active smokers. Evidence suggests that up to 83% of patients who are current smokers at the time of diagnosis continue to smoke.48 Smoking not only increases the risk of metachronous tumors, reduces treatment efficacy, and increases treatment toxicity, but also nearly doubles the risk of death in patients who continue to smoke after a diagnosis of earlystage lung cancer.49,50 Furthermore, the risk of death from other smoking-related conditions, such as coronary heart disease and chronic obstructive pulmonary disorder, is also a significant concern for patients with potentially curable disease.18,51 Although the routine assessment of patient performance status at each office visit was relatively high at baseline among participating physicians, the observed improvement in the execution of this measure was significant. Evaluating performance status at every visit is crucial for monitoring the impact of disease, revising treatment plans when necessary, and managing overall patient health. Cancer Control 95 There are several limitations of this PI study. First, the study is limited by small sample sizes. A larger number of participants and a richer pool of patient chart data would likely provide a clearer picture of the impact of PI in NSCLC patient care. Second, no restrictions on disease stage were present, which further limited the sampling of questions surrounding evidence-based treatment. Third, optimal patient care is an individualized and complex process that cannot necessarily be accurately captured through the generalities of performance measures. Additional limitations were typical of those associated with other reported PI activities.11,52-54 The integrity of the data was reliant on the participants and may have been affected by biases with patient chart selection, self-reporting of performance measures, and the inability to differentiate between improvements in charting and execution of care processes. However, the objective of PI CME is to catalyze change in physician behavior; therefore, participant biases would be self-defeating in nature. PI CME is a method to promote positive changes in physician behavior. Although the educational materials that supported the activity were important to enhance participant knowledge, the opportunity for individual performance change and commitment to that change are the keys to its success. Participants reviewed how evidence-based standards were employed in their practices and developed personalized strategies to attain patient care goals. In turn, this may also have increased the likelihood for changes to be adopted over the long term. Conclusions After completing this initiative focused on patient care for those with non–small-cell lung cancer, participants demonstrated significant gains in applying knowledge from recent scientific advancements in tumor characterization based on histological and genetic features to appropriately classify and treat their patients. Furthermore, notable gains were made in the area of supportive care through the improved assessment of current smoking status and emotional well-being, as well as referral to smoking cessation counseling, which has traditionally been outside the role of the practicing oncologist. With regard to both areas of improvement, these changes are important, fundamental steps toward providing improved comprehensive patient care that more appropriately addresses the physical disease as well as its psychological and lifestyle implications. Appreciation is expressed to Whitney Stevens Dollar for project management and Beth Wills for participant recruitment. They also thank Rebecca Julian, Sara Miller, and Rachel Karcher for editorial assistance, Kenny Khoo for data management, Amy Sison for outcomes management, and Liza King for data analysis. 96 Cancer Control References 1. American Cancer Society. Lung cancer (non-small cell). http://www. cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-smallcell-lung-cancer-key-statistics. Accessed July 15, 2013. 2. US Cancer Statistics Working Group. United States Cancer Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta, GA: Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2010. http://www.cdc.gov/uscs. Accessed July 15, 2013. 3. Hewitt M, Simone JV. Ensuring Quality Cancer Care. Washington, DC: National Academy Press; 1999. http://www.nap.edu/catalog.php?record_ id=6467. Accessed July 15, 2013. 4. Institute of Medicine. 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