14 April 2009

Two Models of Medical Error Reduction Programs in Radiation Oncology



Two Models of Medical Error Reduction Programs in Radiation Oncology
by
Ed Kline
RadPhysics Services LLC
Albuquerque, NM, © RPS


Introduction

* This presentation describes the design, implementation, and results of two QA/medical error reduction programs
* Both programs are designed for
o Reducing preventable systems-related medical errors (i.e., sentinel events, “near misses”)
o Preventing violations of regulatory requirements (i.e., State/NRC)
o Ensuring compliance with recommended standards (i.e., JCAHO, ACR, ACRO, etc.)

History

* Institute of Medicine (IOM) report5
o Focused a great deal of attention on the issue of medical errors and patient safety
o 44,000 to 98,000 deaths per year in U.S. hospitals each year as the result of medical errors
o 10,000 deaths per year in Canadian hospitals
o Exceeds annual death rates from road accidents, breast cancer, and AIDS combined in U.S.


To Err is Human: Building a Safer Health System.


* Key legislation
o Patient Safety Quality Improvement Act9
+ Certifies patient safety organizations in each State to collect data and report on medical errors
o State Patient Safety Centers
+ In past 5 years, 6 states have enacted legislation supporting creation of state patient safety centers
+ 5 of the 6 states now operate patient safety centers
+ Separate mandatory reporting systems for serious adverse events
+ Centers are housed within state regulatory agencies



Reducing Medical Errors, Issue Module, Kaiser EDU.org, Accessed through www.kaiseredu.org.

* Patient safety centers include10
o The Florida Patient Safety Corporation
o The Maryland Patient Safety Center
o The Betsy Lehman Center for Patient Safety and Medical Error Reduction (Massachusetts)
o The New York Center for Patient Safety
o The Oregon Patient Safety Commission
o The Pennsylvania Patient Safety Authority


State Patient Safety Centers: A New Approach to Promote Patient Safety, The Flood Tide Forum, National Academy for State Health Policy, 10/04, Accessed through www.nashp.org.


* State reporting: mandatory vs voluntary11
o Mandatory reporting: Colorado, Florida, Kansas, Nebraska, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington
o Voluntary reporting: District of Columbia, Georgia, New Mexico, North Carolina, Oregon, Wyoming
o Considering new legislation: Arizona, California, Maine
o Mandatory reporting but considering new legislation: Massachusetts, New Jersey


National Conference of State Legislatures, National Academy for State Health Policy, 12/03, Accessed through www.nashp.org.


* JCAHO revises standards
o Patient safety standards effective 7/1/01
o Requires all JCAHO hospitals (5,000) to implement ongoing medical error reduction programs
o Almost 50 percent of JCAHO standards are directly related to safety


Patient Safety - Essentials for Health Care, 2nd edition, Joint Commission on Accreditation of

Healthcare Organizations. Oakbrooke Terrace, IL: Department of Publications, 2004.

* JCAHO’s sentinel event policy13
o Implemented in 1996
o Identify sentinel events
o Take action to prevent their recurrence
o Complete a thorough and credible root cause analysis
o Implement improvements to reduce risk
o Monitor the effectiveness of those improvements
o Root cause analysis must focus on process and system factors
o Improvements must include documentation of a risk-reduction strategy and internal corrective action plan
o Action plan must include measurements of the effectiveness of process and system improvements to reduce risk


Sentinel Event Policies and Procedures - Revised: July 2002, Joint Commission on Accreditation of Healthcare Organizations, Accessed through www.jcaho.org/accredited+organizations/long+term+care/sentinel+events/index.htm.

* JCAHO’s Office of Quality Monitoring
o Receives, evaluates and tracks complaints and reports of concerns about health care organizations relating to quality of care issues
o Conducts unannounced on-site evaluations
* JCAHO and CMS agreement14
o Effective 9/16/04
o Working together to align Hospital Quality Measures (JC’s ORYX Core Measures and CMS’7th Scope of Work Quality of Core Measures)


Joint Commission, CMS to Make Common Performance Measures, Joint Commission on Accreditation of Healthcare Organizations, Accessed through www.jcaho.org/accredited+organizations/long+term+care/sentinel+events.

* CMS quality incentives15
o Quality Improvement Organizations (QIOs)
+ Contracted by CMS to operate in every State
+ 67% of QIOs perform independent quality audits
o Premier Hospital Quality Initiative
+ 3-year demonstration project recognizes and provides financial reward
+ CMS partnership with Premier Inc., nationwide purchasing alliance
+ Hospitals in top 20% of quality for specific diagnosis get financial reward
# Top decile gets 2% Diagnosis Related Group (DRG) bonus
# 2nd decile get 1% DRG bonus
+ Hospitals performing below 9th and 10th decile baseline levels, DRG payments reduced 1% and 2%, respectively


Medicare Looks for Ways to Boost Quality Care Comments Sought on New Plan for Quality Improvement Organizations, Centers for Medicare & Medicare Services (CMS), Accessed through www.cms.hhs.gov.

* CMS quality incentives
o CMS consumer website
+ Beginning in 4/05, hospital quality data available at www.HospitalCompare.hhs.gov or 1-800-MEDICARE
o Data indicators16
+ In 2006, hospitals reporting quality data to Medicare receive 3.7% increase in inpatient payments
+ Non-reporters receive 3.3% increase
+ Data covers 10 quality indicators for cardiology
+ Plans are to expand into other disciplines

and more in this presentation

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Principles of Radiation Oncology



Principles of Radiation Oncology
by
Michael Underbrink, MD
Anna Pou, MD

Introduction

* Increasing use for head and neck cancer
* Combined or as single modality
* Outline basic principles, radiobiology
* General treatment approach
* Common complications

Radiation Physics

* Basis – ionizing particles interact with cellular molecules
* Relies on transfer of energy created by secondary charged particles (usually electrons)
* Break chemical bonds
* External beam vs. Brachytherapy
* Radiant energy is discrete yet random

External Beam Irradiation

* Dual-energy linear accelerators generate:
o Low energy megavoltage x-rays (4-6 MeV)
o High energy x-rays (15-20 MeV)
o Photon energy
* Particle Radiation (electrons, protons, neutrons)
* Photon therapy advantages
o Skin sparing, penetration, beam uniformity
* Head and Neck sites – 4-6 MeV x-ray or Co60 gamma ray radiation

External Beam Irradiation
Brachytherapy

* Radioactive source in direct contact with tumor
o Interstitial implants, intracavitary implants or surface molds
* Greater deliverable dose
* Continuous low dose rate
* Advantage for hypoxic or slow proliferators
* Shorter treatment times

Brachytherapy

* Limitations
o Tumor must be accessible
o Well-demarcated
o Cannot be only modality for tumors with high risk of regional lymph node metastasis


Radiobiology

* Ionizing radiation ejects an electron from a target molecule
* Distributed randomly within cell
* Double-strand DNA breaks – lethal
* Cell death: no longer able to undergo unlimited cell division
* Direct vs. Indirect injury (free radicals – O2)
* Inadequate cellular repair mechanisms implied

Radiobiology

* Random cell death
o Deposition of energy & injury is random event
o Same proportion of cells is damaged per dose
o 100 to 10 cell reduction = 106 to 105 cell reduction
o Larger tumors require more radiation
o 105 cells = nonpalpable
o Applies to normal tissue also
* Therapeutic advantage – 4 R’s of radiobiology

4 R’s of radiation biology

* Repair of cellular damage
* Reoxygenation of the tumor
* Redistribution within the cell cycle
* Repopulation of cells

Repair of sublethal injury

* Sublethal injury – cells exposed to sparse ionization fields, can be repaired
* Killing requires greater total dose when given in several fractions
* Most tissue repair in 3 hours, up to 24 hours
* Allows repair of injured normal tissue, potential therapeutic advantage over tumor cells
* Radioresistance – melanoma?

Reoxygenation

* Oxygen stabilizes free radicals
* Hypoxic cells require more radiation to kill
* Hypoxic tumor areas
o Temporary vessel constriction from mass
o Outgrow blood supply, capillary collapse
* Tumor shrinkage decreases hypoxic areas
* Reinforces fractionated dosing
* Hypoxic cell radiosensitizers, selective chemo


Redistribution

* Cell cycle position sensitive cells
* S phase – radioresistant
* G2 phase delay = increased radioresistance
* RAD9 gene mutation – radiosensitive yeast
* H-ras and c-myc oncogenes - G2 delay
* Fractionated XRT redistributes cells
* Rapid cycling cells more sensitive (mucosa, skin)
* Slow cyclers (connective tissue, brain) spared

Repopulation

* Increased regeneration of surviving fraction
* Rapidly proliferating tumors regenerate faster
* Determines length and timing of therapy course
* Regeneration (tumor) vs. Recuperation (normal)
* Reason for accelerated treatment schedules
* Reason against:
o Treatment delay
o Protracted XRT, split course XRT (designed delay)

Dose-Response Relations

* Control probability variables
o Tumor size
o XRT dose
* Favorable response curves
o Small, well-vascularized tumors
o Homogeneous tumors
* Unfavorable response curves
o Large, bulky tumors (hypoxia)
o Heterogeneous, variable cell numbers
* Normal tissue injury risk increases with XRT dose (size of tumor)

Fractionation Schedules

* Conventional
o 1.8 to 2.0 Gy given 5 times/week
o Total of 6 to 8 weeks
o Effort to minimize late complications
* Accelerated fractionation
o 1.8 to 2.0 Gy given bid/tid
o Similar total dose (less treatment time)
o Minimize tumor repopulation (increase local control)
o Tolerable acute complications (increased)
* Hyperfractionation
o 1.0 to 1.2 Gy bid/tid, 5 times/week
o Similar total treatment time (increased total dose)
o Increases total dose
o Potentially increases local control
o Same rates of late complications
o Increased acute reactions

Treatment Principles

* Size and location of primary
* Presence/absence and extent/incidence of regional or distant metastasis
* General condition of patient
* Early stage cancers
o Surgery alone = XRT alone
o Treatment choice depends on functional deficits
* Late stage – usually combination of treatments
* Surgical salvage of primary radiation failures is better than radiation salvage of surgical failure
* Explains rationale behind organ preservation strategies
* XRT tumor cell killing is exponential function
o Dose required for tumor control is proportional to the logarithm of the number of viable cells in the tumor

Shrinking field technique

* Initial dose = 45 to 50 Gy (4.5 to 5.0 weeks)
o Given through large portals
o Covers areas of possible regional metastasis and primary
* Second dose = 15 to 25 Gy (1.5 to 2.5 weeks)
o Boost field (gross tumor and small margin)
o Total dose of 60 to 75 Gy in 6 to 7.5 weeks
* Boost dose = 10 to 15 Gy
o Massive tumors
o Second field reduction at 60 to 65 Gy
o Total of 7 to 8 weeks

Combined Modalities

* Surgery and XRT complement each other
* Surgery – removes gross tumor (bulky tumors are more difficult to control with XRT)
* XRT – effective for microscopic disease, better with exophytic tumors than ulcerative ones (Surgical failures may leave subclinical disease)
* Combining treatments counteracts limitations
* Pre or Post-operative XRT

Preoperative XRT

* Advantages
o Unresectable lesions may become resectable
o Extent of surgical resection diminished
o Smaller treatment portals
o Microscopic disease more radiosensitive (blood supply)
o Decreased risk of distant metastasis from surgical manipulation?
* Disadvantages
o Decreased wound healing
o Decreased safe dose (45 Gy in 4.5 weeks eradicates subclinical disease in 85% to 90% of patients)
* Advantages
o Better surgical staging
o Greater dose can be given safely (60 to 65 Gy in 6 to 7 weeks)
o Total dose can be based on residual tumor burden
o Surgical resection is easier
o Tissue heals better
* Disadvantages
o Distant metastasis by manipulation?
o Delay in postoperative treatment if healing problems (poorer results if delayed more than 6 weeks)

Complications

* Acute Tissue Reactions
* Late Tissue Reactions

Acute Toxicity

* Time onset depends on cell cycling time
* Mucosal reactions – 2nd week of XRT
* Skin reactions – 5th week
* Generally subside several weeks after completion of treatment

* RTOG – acute toxicity <90>PRINCIPLES OF RADIATION ONCOLOGY

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Challenges in Optimal Delivery of Radiation in Head and Neck Cancers



Challenges in Optimal Delivery of Radiation in Head and Neck Cancers
by
Dr. J P Agarwal, Associate Professor
Department of Radiation Oncology
Tata Memorial Hospital, India

Head and Neck Squamous Cell Carcinoma
General Management Guidelines for H & N Cancers
Head And Neck Radiotherapy
Optimal Dose Delivery With Minimum Acute And Long Term Toxicity
The changing paradigm Wide field radiation Conformal radiation
Head and Neck Immobilization devices
Verification Of Patient Positioning
Immobilization and Set Up Uncertainties
Guidelines For Target Volume Delineation
Heterogeneity In Target Volume Delineation
PET CT Fusion And Effect On PTV

and more topics are in this presentation.


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