Sepsis and Post- Sepsis Syndrome Webinar

The clinical case study of a patient with Traumatic Brain Injury (TBI) who has multiple comorbid conditions and develops sepsis provides the backdrop for two potential clinical pathways—
sepsis and post-sepsis syndrome—and explores the natural history and indicators of poor prognosis
in both conditions. Attendees explore the benefits of early identification of hospice eligibility for patients with sepsis, and timely referrals to hospice care from acute and post-acute care settings.

1. Sepsis and Post-Sepsis Syndrome

2. CME Provider Information Satisfactory Completion Learners must complete an evaluation form to receive a certificate of completion. You must participate in the entire activity as partial credit is not available. If you are seeking continuing education credit for a specialty not listed below, it is your responsibility to contact your licensing/certification board to determine course eligibility for your licensing/certification requirement. Physicians In support of improving patient care, this activity has been planned and implemented by Amedco LLC and VITAS ® Healthcare. Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Credit Designation Statement – Amedco LLC designates this live activity for a maximum of 1 AMA PRA Category 1 Credit TM . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

3. VITAS Healthcare programs are provided CE credits for their Nurses/Social Workers and Nursing Home Administrators through: VITAS Healthcare Corporation of Florida, Inc./CE Broker Number: 50-2135. Approved By: Florida Board of Nursing/Florida Board of Nursing Home Administrators/Florida Board of Clinical Social Workers, Marriage and Family Therapy & Mental Health Counseling.  VITAS Healthcare programs in Illinois are provided CE credit for their Nursing Home Administrators and Respiratory Therapists through:   VITAS Healthcare Corporation of Illinois, Inc./8525 West 183 Street, Tinley Park, IL 60487/NHA CE Provider Number: 139000207/RT CE Provider Number: 195000028/Approved By the Illinois Division of Profession Regulation for: Licensed Nursing Home Administrators and Illinois Respiratory Care Practitioner. VITAS Healthcare, #1222, is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved as ACE providers. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit. VITAS Healthcare maintains responsibility for this course. ACE provider approval period: 06/06/2024 – 06/06/2027. Social workers completing this course receive 1.0 ethics continuing education credits. VITAS Healthcare Corporation of California, 310 Commerce, Suite 200, Irvine, CA 92602. Provider approved by the California Board of Registered Nursing, Provider Number 10517, expiring 01/31/2025. Exceptions to the above are as follows: AL: No NHAs, DE: No NHAs, DC: No NHAs, GA: No NHAs, KS: No NHAs, NJ: No NHAs,  OH: No NHAs, PA: No NHAs, TX: No NHAs, VA: No NHAs, WI: No NHAs and Nurses are not required – RT only receive CE Credit in Illinois CE Provider Information

4. Goal Appreciate the role of hospice in the care of patients who develop sepsis in acute-care hospital and post-acute care settings Discuss the role of post-sepsis syndrome and characteristics that support hospice eligibility

5. Objectives Appreciate the impact of sepsis and post-sepsis syndrome to the US healthcare system Describe hospice eligibility for patients experiencing sepsis Hospitalization Post-acute Understand indicators of poor prognosis in sepsis and post-sepsis syndrome Discover how hospice can help support patients with sepsis and post-sepsis syndrome

6. 1 US Centers for Disease Control and Prevention. Data and Reports, retrieved from: https:// www.cdc.gov /sepsis/ datareports / index.html . Retrieved June 13, 2024. 2 World Health Organization. (2021). WHO calls for global action on sepsis: cause of 1 in 5 deaths worldwide. Retrieved from: https:// www.who.int /news/item/08-09-2020-who-calls-for-global-action-on-sepsis---cause-of-1-in-5-deaths-worldwide 3 Rhee, C., et al. (2017). Incidence and trends of sepsis in US hospitals using clinical vs claim data, 2009 to 2014. JAMA , 318(13), 1241-1249. 4 Thompson, K., et al. (2018). Health-related outcomes of critically ill patients with and without sepsis. Intensive Care Med, 44(8):1249-1257. Sepsis affects 1.7 million people per year in the US and 270,000 die from it 1 50 million worldwide and 11 million deaths 2 About 1 in 3 patients or more who die in a hospital have sepsis; many are hospice-eligible at admission 3 Recommendations exist for inpatient hospital care Standard/rapid identification and management 30% of sepsis survivors suffer from post-sepsis syndrome 4 No consensus recommendations exist on best post-acute care New symptom burden Pain, fatigue, dysphagia, poor attention, shortness of breath Long-term disability: cognitive and physical function Higher risk of hospital readmission and death compared to other conditions Background

7. Who is at Risk? Centers for Disease Control & Prevention (2022). What is Sepsis? Available at: https:// www.cdc.gov /sepsis/what-is- sepsis.html Anyone can develop sepsis, but some people are at higher risk for sepsis: People with chronic medical conditions, such as diabetes, lung disease, cancer, and kidney disease People who survived sepsis People with weakened immune systems People with recent severe illness or hospitalization Children younger than one Adults 65 or older

8. Sepsis and Healthcare Costs The cost of sepsis and post-sepsis care continues to be a serious healthcare burden Sepsis costs accounted for $62 billion in 2019 (including inpatient and skilled nursing admissions), making it the most expensive condition treated in US hospitals 1 Sepsis cost of care: 2 Hospital-acquired: $51,000 Community-acquired: $18,000 The comparative cost of care by disease states: 3 Diabetes: $32,000 vs. non-diabetes: $13,000 Readmission cost averaged $25,000 4 1 Buchman, T., et al. (2020). Sepsis Among Medicare Beneficiaries: 3. The Methods, Models, and Forecasts of Sepsis, 2012-2018. Critical Care Medicine ; 48:302-318. 2 Paoli, CJ et al. Epidemiology and Costs of Sepsis in the United States—An Analysis Based on Timing of Diagnosis and Severity Level. Crit Care Med 2018; 46:1889-97. 3 Hajj, J., et al., The “centrality of sepsis”: a review on incidence, mortality, and cost of care. In  Healthcare  (Vol. 6, No. 3, p. 90). Multidisciplinary Digital Publishing Institute. 4 Gluck, T. (2019). Epidemiology and Costs of Sepsis in the U.S. NEMJ Journal Watch. Retrieved from: https://www.jwatch.org/na48114/2019/01/02/epidemiology-and-costs-sepsis-us.

9. Case of Mrs. “HS” HPI 66 y/o female with history of neurologic compromise s/p distant TBI presents to ED with AMS of unknown origin. PCG husband provides limited history of “she was acting funny and I heard her gurgling when she laid down for a nap” PMHx TBI with cognitive impairment. Hx aspiration PNA. Osteoporosis, dysphagia, L arm contractures/immobility. Unsteady gait with recent falls at home, 3/6 ADL dependency Initial Studies CXR = RLL PNA and generalized pneumonitis c/w aspiration PNA Pt with AMS and new O2 requirement Exam Poor attention, temp. 104 ºF, pulse 120 bpm, RR 28/min, BP 90/60, WBC 15 and 15% bands, lung sounds with bilateral congestion and wheezing to bases, scattered ecchymosis c/w recent falls

10. Sepsis is a life-threatening illness with host dysregulation brought on by the body’s response to an infection Sepsis can lead to: Severe sepsis (acute organ dysfunction secondary to documented or suspected infection) Septic shock (severe sepsis plus hypotension not reversed with fluid resuscitation) Post-sepsis syndrome (immune, inflammatory, and endocrine changes resulting in cognitive and physical impairments) What Is Sepsis?

11. In 1991, SIRS criteria consensus conference established “Sepsis-1” Sepsis-1 diagnosis requires at least 2 of the following: Tachycardia (heart rate > 90 beats/min) Tachypnea (respiratory rate > 20 breaths/min) Fever or hypothermia (temperature > 38ºC or < 36ºC) Leukocytosis, leukopenia, or bandemia (white blood cells > 1,200/mm 3 , < 4,000/mm 3 , or bandemia ≥ 10%) Sepsis is infection or suspected infection leading to SIRS SIRS: Systemic Inflammatory Response Syndrome

12. SOFA: Sequential Organ Failure Assessment Score Marik , P., et al. (2017). SIRS, qSOFA and new sepsis definition. Journal of Thoracic Disease, 9(4), 943. Max SOFA Score Mortality, % 0-6 < 10 7-9 15-20 10-12 40-50 13-14 50-60 15 > 80 15-24 > 90

13. ©2019 VITAS ® Healthcare Corporation Adapted from Prescott, H. & Angus, D. (2018). Enhancing Recovery from Sepsis: A Review.  JAMA , 319(1), 62-75. Sepsis: Important Factors in Clinical Course and Outcomes Complex interactions among host, medical conditions, contextual, and pathogen factors Complex interactions among interaction among host factors, medical conditions, manifestations of sepsis, and treatments Pre-sepsis (3 months ) Onset of sepsis Hospitalization for sepsis Post-sepsis (3 months) Host risk factors nutritional status, functional status, cognitive status, uncontrolled symptoms Medical conditions advanced illness, multimorbidity, frailty Contextual features recent hospitalizations, ED visits, social determinants of health Pathogen factors virulence, load, antibiotic susceptibility, other Clinical manifestations circulatory shock, respiratory failure, renal injury, delirium, coma, coagulopathy, metabolic changes and increased lactate, other System dysregulation immune, inflammatory, endocrine, microbiome, other Treatment considerations sepsis protocol, manage pain and agitation, hospice care for non-responders/declining with treatment or goals-of-care comfort Clinical manifestations progression of host factors and/or medical conditions to end stage, recurrent infections, exacerbation of heart failure, COPD or acute renal failure, refractory delirium/cognitive impairment, swallowing dysfunction with dysphagia Contextual factors hospital readmission, ED visits Post-acute care skilled facility, home health, no post-acute care, hospice Resolution of the acute septic episode

14. Background: Sepsis Epidemiology ©2019 VITAS ® Healthcare Corporation Adapted from Prescott, H. & Angus, D. (2018). Enhancing Recovery from Sepsis: A Review.  JAMA, 319(1), 62-75. 41% of patients admitted with sepsis die within 90 days 42% of patients who survive are readmitted within 90 days 1 in 2-3 dies 1 in 3 hospital deaths are sepsis-related <1 in 5 admitted to hospice

15. 1 US Department of Health and Human Services. (2020). Solving Sepsis: Transforming Health Security. Retrieved from DRIVe.HHS.gov 2 Prescott, H., et al. (2018). Enhancing Recovery from Sepsis: A Review. JAMA , 319(1), 62-75. 3 Thompson, K., et al. (2018). Health outcomes of critically ill patients with and without sepsis. Intensive Care Medicine , 1249-1257. doi : 10.1007/s00134-018-5274-x. Physical location 80% community-acquired 1 26% healthcare-associated (NH/recent hospital/dialysis) 7.5% hospital-acquired 2 20% of all deaths are sepsis-related 30% of sepsis survivors experience post-sepsis syndrome 3 Body location Pneumonia (40%) Abdominal Genitourinary Primary bacteremia Skin/soft tissue infection Sepsis Characteristics

16. Case of Mrs. “HS” continues Day 1 Day 8 Day 5 48 hrs Hospital Admission 48 hours post-admission, condition worsened Mechanical ventilation initiated for acute respiratory failure, secondary to bilateral pneumonia Acute renal failure; hemodialysis initiated IV vasopressors initiated Thrombocytopenia Hyperlactatemia Admitted to ICU from ED; Sepsis Alert System activated Multiple IV antibiotics Volume resuscitation NPO/speech eval

17. Rhee, C., et al. (2019). Prevalence, underlying causes, and preventability of sepsis-associated mortality in US acute care hospitals. JAMA Network Open , 2(2), e187571-e187571. An estimated 25%-50% of hospital deaths are sepsis-related Sepsis was present on admission: 93% Developed sepsis during hospital stay: 7.5% Compared to patients who died in the hospital without sepsis, hospitalized patients who died of sepsis were more likely to: Be admitted from acute rehabilitation or long-term care Be admitted to the intensive care unit Die in the hospital than on hospice Sepsis and Hospital Mortality

18. Rhee, C., et al. (2019). Prevalence, underlying causes, and preventability of sepsis-associated mortality in US acute care hospitals. JAMA Network Open , 2(2), e187571-e187571. All Deaths 568 patients included in analysis 395 (69.5%) died in the hospital 173 (30.5%) discharged to hospice Of the 173 patients discharged to hospice 59 (34.1%) died within 1 week Sepsis vs. Non-Sepsis Deaths 19% of sepsis deaths were referred to hospice 43.3% non-sepsis deaths were referred to hospice Hospital Deaths, Sepsis, and Hospice

19. Factors Associated With Hospital-Related Death Rhee, C., et al. (2019). Prevalence, underlying causes, and preventability of sepsis-associated mortality in US acute care hospitals. JAMA Network Open , 2(2), e187571-e187571. A greater number of organs with dysfunction increases the likelihood of hospital death and the need for a goals-of-care conversation. Organ dysfunction or mortality, % Organ dysfunction or mortality, % Number of criteria met Proportion of sepsis cases with organ dysfunction Associated mortality

20. Pre-hospitalization Conditions: Hospice-eligible: Post-traumatic encephalopathy SOB with minimal exertion Hospitalization for COPD exacerbation and pneumonia dysphagia Functional decline: 3 of 6 ADL dependent Unsteady gait Multiple recent falls Sepsis-associated organ dysfunction: Vasopressor initiation Mechanical ventilation initiation Hyperlactatemia Acute kidney injury Thrombocytopenia Case of Mrs. “HS”: Sepsis Course

21. Case of Mrs. “HS”: Sepsis Course 5 days post-admission, condition has not improved Ventilator-dependent Palliative care consult to discuss goals of care (GOC), and ? trach and PEG tube placement Husband reveals patient’s specific stated wishes. Trach and PEG tube deferred Referral for VITAS hospice services with general inpatient (GIP) level of care Day 1 Day 8 Day 5 48 hrs Hospital Admission

22. Case of Mrs. “HS”: Sepsis Course (cont.) 8 days post-admission – Compassionate extubation along with admission to VITAS GIP level of care for management of SOB and restlessness Day 1 Day 8 Day 5 48 hrs Hospital Admission During the night, HS’ vital signs deteriorate, and she shows signs of restlessness: Hospital nurse calls VITAS Telecare VITAS Telecare clinician dispatches VITAS RN to hospital VITAS RN confirms that HS is actively dying and administers medication for symptom management VITAS RN notifies on-call psychosocial staff member to support husband at bedside HS responds to medication and is resting comfortably 6 hours later, HS passes peacefully with husband at bedside Bereavement support provided to family

23. Prescott, H., et al. (2018). Enhancing Recovery from Sepsis: A Review. JAMA , 319(1), 62-75. New functional limitations 1-2 new ADL limitations on average Physical weakness Myopathy and neuropathy Increased cognitive impairment (CI) Persistent delirium Moderate to severe CI increased from 6.1% before hospitalization to 16.7% post-hospitalization Difficulty swallowing 63% aspiration on fiberoptic endoscopic evaluation Muscular weakness or damage Post-Sepsis Syndrome (cont.)

24. Sepsis Cognitive and Functional Outcomes Iwashyna , T., et al. (2010). Long-Term Cognitive Impairment and Functional Disability Among Survivors of Severe Sepsis. JAMA , 304(16), 1797-1794.

25. Prescott, H., et al. (2018). Enhancing Recovery from Sepsis: A Review. JAMA , 319(1), 62-75. Cardiovascular events occurred in 29.5% of patients in the year after sepsis Persistent myocardial dysfunction Increased risk of recurring sepsis 9-fold elevated risk Increased depression and anxiety About 33% prevalent 2-3 months later Exacerbation of chronic medical conditions Heart failure, acute renal failure, and COPD Post-Sepsis Syndrome (cont.)

26. Sepsis and Post-Acute Care Utilization Buchman, T., et al. (2020). Sepsis Among Medicare Beneficiaries: 2. The Trajectories of Sepsis, 2012–2018. Critical Care Medicine , 48(3), 289.

27. Sepsis and Readmissions Jones, T., et al. (2015). Post–acute care use and hospital readmission after sepsis. Annals of the American Thoracic Society , 12(6), 904-913. Patients who are readmitted to the hospital within 30 days of an initial sepsis episode are twice as likely to die or enroll in hospice as patients not admitted for sepsis

28. Iwashyna , T., Ely, E., Smith, D., & Langa , K. (2010). Long-Term Cognitive Impairment and Functional Disability Among Survivors of Severe Sepsis. JAMA, 304(16), 1797-1794. Pre-Sepsis Function and Cognition on Post-Hospital Survival Patients with functional and cognitive impairment prior to sepsis who survive hospitalization have a high 6-month mortality that supports hospice as a relevant and important post-acute care option

29. Disease Group No Hospice Hospice < 15 Days 15 – 30 31 – 60 61 – 90 91 – 180 181 – 266 > 266 ALL $67,192 4% - 5% - 9% - 12% - 14% - 10% - 12% Circulatory $66,041 7% - 4% - 8% - 10% - 11% - 8% - 10% Cancer $76,625 10% - 1% - 6% - 9% - 13% - 14% - 20% Neuro- degenerative $61,004 12% - 6% - 9% - 11% - 11% - 5% - 4% Respiratory $77,892 - 2% - 11% - 14% - 17% - 19% - 18% - 22% CKD/ESRD $82,781 1% - 14% - 21% - 24% - 24% - 23% - 27% Comparison of Total Cost of Care by Disease Group and Hospice Episodes in the 12-Month Period Before Death *To be eligible to elect hospice care under Medicare, an individual must be entitled to Part A of Medicare and be certified as being terminally ill. An individual is considered to be terminally ill if the medical prognosis is that the individual’s life expectancy is 6 months or less if the illness runs its normal course. Only care provided by (or under arrangements made by) a Medicare certified hospice is covered under the Medicare hospice benefit. The hospice admits a patient only on the recommendation of the medical director in consultation with, or with input from, the patient's attending physician (if any). NORC at the University of Chicago (2023). Value of Hospice in Medicare. Available at: https://www.nhpco.org/wp-content/uploads/Value_Hospice_in_Medicare.pdf Hospice care saved Medicare approximately $3.5 billion for patients in their last year of life Those patients with hospice stays of ≥ 6 months* yielded the highest percentage of savings For patients whose hospice stays were between 181- 266 days, total cost of care was almost $7K less than non- hospice users Hospice patients with stays of > 266 days spent approximately $8K less than non- hospice users Spending is greater than Spending is less than non- hospice users non- hospice users No Difference / Not Statistically Significant

30. The Medicare Hospice Benefit is a 6-Month Benefit: Quality and Cost Evidence Corroborate the Need for Timely Access* *To be eligible to elect hospice care under Medicare, an individual must be entitled to Part A of Medicare and be certified as being terminally ill. An individual is considered to be terminally ill if the medical prognosis is that the individual’s life expectancy is 6 months or less if the illness runs its normal course. Only care provided by (or under arrangements made by) a Medicare certified hospice is covered under the Medicare hospice benefit. The hospice admits a patient only on the recommendation of the medical director in consultation with, or with input from, the patient's attending physician (if any). NORC at the University of Chicago (2023). Value of Hospice in Medicare. Available at: https:// www.nhpco.org /wp-content/uploads/ Value_Hospice_in_Medicare.pdf Over the last 12 months of life, as hospice use increases, total spending decreases relative to non- hospice users The reduction in costs when patients across all disease classes use hospice can be significant

31. Benefits of Early Identification of Hospice-Eligible Sepsis Patients and Alignment With Care Goals Quality Hospital readmissions Advance care planning Symptom management Patient experience Hospital mortality Medicare spend per-beneficiary Bereavement HME and Supplies Oxygen Non-invasive ventilation Hospital bed Specialized mattress ADL assist d evices Incontinence supplies Wound care supplies Complex Modalities Antibiotics IV hydration Parenteral opioids Respiratory therapist Therapy services: PT, OT, speech Nutritional counseling Goals-of-care conversations High-Acuity Care Telecare Intensive Comfort Care ® General inpatient care Visits after hours and on weekends/holidays Visit frequency Physician support Levels of Care Home/routine Respite Continuous Inpatient

32. Goals of Care (GOC) Conversation Develop a collaborative plan Understand what patient and caregiver know Listen to goals and expectations Inform of evidence-based information Build trust and respect Person-Centric Care

33. Questions

34. Additional Hospice Resources The VITAS mobile app includes helpful tools and information: Interactive Palliative Performance Scale (PPS) Body-Mass Index (BMI) calculator Opioid converter Disease-specific hospice eligibility guidelines Hospice care discussion guides We look forward to having you attend some of our future webinars! Scan now to download the VITAS app.

35. Adapted from Prescott, H. & Angus, D. (2018). Enhancing recovery from sepsis: a review.  JAMA , 319(1), 62-75. Buchman, T., et al. (2020). Sepsis among Medicare beneficiaries: 3. The methods, Models, and Forecasts of Sepsis, 2012-2018. Critical Care Medicine ; 48:302-318. US Centers for Disease Control and Prevention. (2020). Data and Reports, Available at: https:// www.cdc.gov /sepsis/ datareports / index.html US Centers for Disease Control and Prevention (2022). What is Sepsis? Available at: https:// www.cdc.gov /sepsis/what-is- sepsis.html Datta, R., et al. (2019). Increased Length of Stay Associated with Antibiotic Use in Older Adults with Advanced Cancer Transitioned to Comfort Measures. American Journal of Hospice and Palliative Medicine , 37(1): 27-33. doi : 10.1177/1049909119855617 Gluck, T. (2019). Epidemiology and Costs of Sepsis in the U.S. NEMJ Journal Watch. Retrieved from: https://www.jwatch.org/na48114/2019/01/02/epidemiology-and-costs-sepsis-us Hajj, J., et al. (2018). The “centrality of sepsis”: a review on incidence, mortality, and cost of care. In  Healthcare  (Vol. 6, No. 3, p. 90). Multidisciplinary Digital Publishing Institute. Iwashyna , T., Ely, E., Smith, D., & Langa , K. (2010). Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA , 304(16), 1797-1794. Jones, T., et al. (2015). Post–acute care use and hospital readmission after sepsis. Annals of the American Thoracic Society , 12(6), 904-913. Marik , P., et al. (2017). SIRS, qSOFA and new sepsis definition. Journal of Thoracic Disease, 9(4), 943. NORC at the University of Chicago (2023). Value of Hospice in Medicare. Available at: https://www.nhpco.org/wp-content/uploads/Value_Hospice_in_Medicare.pdf References

36. Prescott, H. & Angus, D. (2018). Enhancing recovery from sepsis: a review. JAMA, 319(1), 62-75. Rhee, C., et al. (2017). Incidence and trends of sepsis in US hospitals using clinical vs claim data, 2009 to 2014. JAMA , 318(13), 1241-1249. Rhee, C., et al. (2019). Prevalence, underlying causes, and preventability of sepsis-associated mortality in US acute care hospitals. JAMA Network Open , 2(2), e187571-e187571. Riester , M., et al. (2022) “Causes and timing of 30-day rehospitalization from skilled nursing facilities after a hospital admission for pneumonia or sepsis.” PloS one vol. 17,1 e0260664. Thompson, K., et al. (2018). Health-related outcomes of critically ill patients with and without sepsis. Intensive Care Med . 44(8):1249-1257. US Centers for Disease Control and Prevention. (2020). Data and Reports, retrieved from: https:// www.cdc.gov /sepsis/ datareports / index.html US Department of Health and Human Services. (2020). Solving Sepsis: Transforming Health Security. Retrieved from DRIVe.HHS.gov World Health Organization. 2021. WHO calls for global action on sepsis: cause of 1 in 5 deaths worldwide. Retrieved from: https:// www.who.int /news/item/08-09-2020-who-calls-for-global-action-on-sepsis---cause-of-1-in-5-deaths-worldwide Yende , S., et al. (2019). Long-term Host Immune Response Trajectories Among Hospitalized Patients With Sepsis. JAMA Network Open , August, 2(8), e198686. References

37. This document contains confidential and proprietary business information and may not be further distributed in any way, including but not limited to email. This presentation is designed for clinicians. While it cannot replace professional clinical judgment, it is intended to guide clinicians and healthcare professionals in establishing hospice eligibility for patients with advanced Alzheimer's and dementia. It is provided for general educational and informational purposes only, without a guarantee of the correctness or completeness of the material presented.