Shared Decision Making, Decision Support and Breast Conservation Therapy
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Transcript of Shared Decision Making, Decision Support and Breast Conservation Therapy
Shared Decision Making, Decision Support and
Breast Conserving Therapy
Shared Decision Making, Decision Support and
Breast Conserving Therapy
Matthew S. Katz, MD
Radiation Oncology Associates, PA
Saints Medical Center
Lowell, MA
April 27, 2009
Matthew S. Katz, MD
Radiation Oncology Associates, PA
Saints Medical Center
Lowell, MA
April 27, 2009
Shared decision making (SDM) and informed consent Background Patient-related factors Role of health care professional SDM in Breast Conserving Therapy (BCT)
Decision Aids and Decision Support Definition Goals Role in SDM
Shared decision making (SDM) and informed consent Background Patient-related factors Role of health care professional SDM in Breast Conserving Therapy (BCT)
Decision Aids and Decision Support Definition Goals Role in SDM
OverviewOverview
Decision support tools Nomograms IBTR! Effect on BCT utilization Relevance to multidisciplinary setting
Conclusions
Decision support tools Nomograms IBTR! Effect on BCT utilization Relevance to multidisciplinary setting
Conclusions
OverviewOverview
What I learned in medical school
What I learned in medical school
Doctor-Patient Relationship
Doctor-Patient Relationship
Docere = to teach
Obligated to transmit increasingly complex information to facilitate decision making
Increasingly collaborative rather than paternalistic
Docere = to teach
Obligated to transmit increasingly complex information to facilitate decision making
Increasingly collaborative rather than paternalistic
Challenges in Making Treatment Recommendations
Challenges in Making Treatment Recommendations
Do patients understand their own needs when making treatment decisions?
Each patient has different levels of need for information, support and autonomy
Patient’s needs/expectations change over time
Do patients understand their own needs when making treatment decisions?
Each patient has different levels of need for information, support and autonomy
Patient’s needs/expectations change over time
Shared Decision MakingShared Decision Making
More actively engages patients in becomes partners in decision-making process
Opportunity for clinicians to educate and reassure
Risk of increasing patient anxiety
More actively engages patients in becomes partners in decision-making process
Opportunity for clinicians to educate and reassure
Risk of increasing patient anxiety
Key Elements of SDMKey Elements of SDM
Patient knowledge
Explicit encouragement of patient participation
Appreciation of the patient's ability to play an active role in decision
Awareness of choice
Time
Patient knowledge
Explicit encouragement of patient participation
Appreciation of the patient's ability to play an active role in decision
Awareness of choice
Time
Fraenkel & McGraw, J Gen Intern Med. 2007
What factors contribute topatient’s decision process?What factors contribute to
patient’s decision process?
At time of decision Knowledge Deficit Preferred decisional role Uncertainty Anxiety
Evaluation of Decision Satisfaction Decisional Regret Provider Trust
At time of decision Knowledge Deficit Preferred decisional role Uncertainty Anxiety
Evaluation of Decision Satisfaction Decisional Regret Provider Trust
Tools to Assess SDMTools to Assess SDM
Breast Cancer Information Test
State-Trait Anxiety Inventory
CES-D Scale
Decisional Conflict Scale:
Knowledge, Values, Certainty, Support
Decisional Preferences Scale
Others
Breast Cancer Information Test
State-Trait Anxiety Inventory
CES-D Scale
Decisional Conflict Scale:
Knowledge, Values, Certainty, Support
Decisional Preferences Scale
Others
Information NeedsInformation Needs
Essential for informed consent Transmission of information Comprehension
Whether information is considered relevant by patient and clinician can vary
Patients express desire to know more, whether negative or positive
Essential for informed consent Transmission of information Comprehension
Whether information is considered relevant by patient and clinician can vary
Patients express desire to know more, whether negative or positive
Breast Conserving TherapyBreast Conserving Therapy
Since early to mid-1980s, lumpectomy + radiation therapy have been considered equally effective as mastectomy
Majority of women prefer BCT to mastectomy when offered both options
Since early to mid-1980s, lumpectomy + radiation therapy have been considered equally effective as mastectomy
Majority of women prefer BCT to mastectomy when offered both options
How informed are decisions about BCT?
How informed are decisions about BCT?
Population based sample of 1844 women Only 48% knew that survival is equal between
mastectomy and BCT
Only 16% knew that BCT may have higher local recurrence rate than mastectomy
Lower knowledge with:
male surgeon
lack of treatment options
less Internet or health pamphlet use
Population based sample of 1844 women Only 48% knew that survival is equal between
mastectomy and BCT
Only 16% knew that BCT may have higher local recurrence rate than mastectomy
Lower knowledge with:
male surgeon
lack of treatment options
less Internet or health pamphlet use
Fagerlin et al, Patient Ed Counseling 2006
What decisional role docancer patients want?
What decisional role docancer patients want?
Preferred Role Incidence
Active 20 - 39%
Collaborative 28 - 64%
Passive 8 - 52%
True autonomy in decision-making is rare (0.5-1%)
Preferred Role Incidence
Active 20 - 39%
Collaborative 28 - 64%
Passive 8 - 52%
True autonomy in decision-making is rare (0.5-1%)
Deber et al, Health Expectations 2007
Desired vs. Actual Role in Breast Cancer
Desired vs. Actual Role in Breast Cancer
Survey of 145 women with breast CA 1 week after surgery or neoadjuvant chemotherapy
Only 41% felt they had a choice in their treatment
63% had desired decisional role 30% preferred SDM 78% preferring active or passive
Survey of 145 women with breast CA 1 week after surgery or neoadjuvant chemotherapy
Only 41% felt they had a choice in their treatment
63% had desired decisional role 30% preferred SDM 78% preferring active or passive
Vogel et al, Psychooncology 2008
Preferred Role and Psychological Distress
Preferred Role and Psychological Distress
Passive preference associated with depression
SDM preference patients had highest anxiety levels
Passive preference associated with depression
SDM preference patients had highest anxiety levels
Vogel et al, Psychooncology 2008
Do breast cancer patients’desired role change?
Do breast cancer patients’desired role change?
Longitudinal study of 205 breast cancer patients
Desired decision-making role asessed at baseline
Active, Collaborative or Passive
Subsequently asked again ~ 3 years later
Longitudinal study of 205 breast cancer patients
Desired decision-making role asessed at baseline
Active, Collaborative or Passive
Subsequently asked again ~ 3 years later
Hack et al, Psychooncology 2006
Baseline Preferred Role
Active Collaborative Passive Total
Role Preference at 3 years
A 33 18 21 36%
C 19 22 43 42%
P 3 2 41 22%
27% 21% 52%
Hack et al, Psychooncology 2006
Desired role changes over timeDesired role changes over time
• “Active” patients had better QoL, physical, emotional metrics and less fatigue through treatment
• Patients that had been passive expressed ‘role regret’ more than decisional regret
• “Active” patients had better QoL, physical, emotional metrics and less fatigue through treatment
• Patients that had been passive expressed ‘role regret’ more than decisional regret
Hack et al, Psychooncology 2006
Satisfaction andProvider Trust after BCS
Satisfaction andProvider Trust after BCS
U Michigan survey of 714 breast cancer patients after BCS
Patients answered several months to several years after initial plans for BCS
Rated satisfaction, decisional conflict, decisional regret and provider trust
U Michigan survey of 714 breast cancer patients after BCS
Patients answered several months to several years after initial plans for BCS
Rated satisfaction, decisional conflict, decisional regret and provider trust
Walgee et al, Cancer 2008
Surgical ResultsSurgical Results
Re-Excision
One 43%
Two 12%
Required Mastectomy 11%
Infection 13%
Seroma 14%
Breast Asymmetry
Minimal 36%
Moderate 33%
Large 30%
Re-Excision
One 43%
Two 12%
Required Mastectomy 11%
Infection 13%
Seroma 14%
Breast Asymmetry
Minimal 36%
Moderate 33%
Large 30%
Walgee et al, Cancer 2008
Decisional Conflict and Regret
Decisional Conflict and Regret
Endpoint %
Certain of decision 55
Prepared to make decision 61
Felt effective in the
decision-making process 87
Regretted decision 13
Endpoint %
Certain of decision 55
Prepared to make decision 61
Felt effective in the
decision-making process 87
Regretted decision 13
Walgee et al, Cancer 2008
Patient SatisfactionPatient Satisfaction
No correlation with #re-excisions, complications or need for mastectomy
Breast asymmetry is associated with less satisfaction, less certainty in decision for BCS and more decisional regret
Women receiving RT more likely to feel have decisional conflict
No correlation with #re-excisions, complications or need for mastectomy
Breast asymmetry is associated with less satisfaction, less certainty in decision for BCS and more decisional regret
Women receiving RT more likely to feel have decisional conflict
Walgee et al, Cancer 2008
Provider TrustProvider Trust
Lower MD trust with asymmetry, postop complications, need for re-excision
Trend toward less MD trust with higher education and Caucasian ethnicity
Lower MD trust with asymmetry, postop complications, need for re-excision
Trend toward less MD trust with higher education and Caucasian ethnicity
Walgee et al, Cancer 2008
Differences by AgeDifferences by Age
Older women tend to make more immediate decisions Limited cognitive resources Greater knowledge/experience More likely to take passive role
Often have lower QoL, physical and emotional functioning scores
Older women still benefit from SDM
Older women tend to make more immediate decisions Limited cognitive resources Greater knowledge/experience More likely to take passive role
Often have lower QoL, physical and emotional functioning scores
Older women still benefit from SDMMeyer & Talbot, Psych Aging 2008Hack et al, Psychooncology 2006Liang et al, JCO 2002
What Barriers to Doctors see to SDM?
What Barriers to Doctors see to SDM?
Doctor-Related:
Insufficient information @ 1st Visit 29%
Insufficient time with the patient 28%
Patient-Related:
Misconceptions about disease 27%
Indecision 24%
Anxiety 22%
Lack of understand of information 20%
Doctor-Related:
Insufficient information @ 1st Visit 29%
Insufficient time with the patient 28%
Patient-Related:
Misconceptions about disease 27%
Indecision 24%
Anxiety 22%
Lack of understand of information 20%
Shepard et al, JCO 2008
Can clinicians interpret the patients’ desired role?Can clinicians interpret
the patients’ desired role?
101 candidates for BCS evaluated at baseline and f/u interview
Surgeons of these patients also interviewed
Assessed patient preference, patient and MD’s perception of the decision-making process
Average consultation = 21 minutes
101 candidates for BCS evaluated at baseline and f/u interview
Surgeons of these patients also interviewed
Assessed patient preference, patient and MD’s perception of the decision-making process
Average consultation = 21 minutes
Jann et al, JCO 2004
85% of women wanted shared or active role
Among patients desiring shared role: 50% felt more active than preferred 16% didn’t feel involved enough
Perception of patient and doctor correlated in only 38%
85% of women wanted shared or active role
Among patients desiring shared role: 50% felt more active than preferred 16% didn’t feel involved enough
Perception of patient and doctor correlated in only 38%
Jann et al, JCO 2004
PerceivedDecision-Making Process
PerceivedDecision-Making Process
Type of Decision Patient MD
Patient Only 6% 17%
Patient with MD Input 56% 25%
SDM 30% 56%
MD 8% 8%
Patient satisfaction correlated to perceived rather than preferred role
Similar study showed clinicians have difficulty assessing patient’s desired role
Type of Decision Patient MD
Patient Only 6% 17%
Patient with MD Input 56% 25%
SDM 30% 56%
MD 8% 8%
Patient satisfaction correlated to perceived rather than preferred role
Similar study showed clinicians have difficulty assessing patient’s desired role
Jann et al, JCO 2004Hudak et al, Med Decis Making 2008
SDM and Breast Conserving Therapy
SDM and Breast Conserving Therapy
Early stage patients have several different treatment options
Mastectomy +/- reconstruction
BCS +/- RT
Whole breast RT
APBI External Beam, MammoSite, Interstitial
Intraoperative
Early stage patients have several different treatment options
Mastectomy +/- reconstruction
BCS +/- RT
Whole breast RT
APBI External Beam, MammoSite, Interstitial
Intraoperative
Decisional Aids and BCSDecisional Aids and BCS
Walgee et al, JCO 2007
Increased BCS with DAIncreased BCS with DA
Walgee et al, JCO 2007
DA Enhances Patient Knowledge
DA Enhances Patient Knowledge
Walgee et al, JCO 2007
Decision Board from JAMADecision Board from JAMA
Whelan et al, JAMA 2004
May improve: Knowledge Patient satisfaction Improve physical/emotional function
May reduce: Decisional conflict Sensation of pain
No increased anxiety/depression using a DA
May improve: Knowledge Patient satisfaction Improve physical/emotional function
May reduce: Decisional conflict Sensation of pain
No increased anxiety/depression using a DA
Walgee et al, JCO 2007
Decision Aids (DA)Decision Aids (DA)
62% of patients felt a DA improved communication with the doctor
98% would recommend using the DA to other patients
DA use also favored by physicians
62% of patients felt a DA improved communication with the doctor
98% would recommend using the DA to other patients
DA use also favored by physicians
Walgee et al, JCO 2007
Decision SupportDecision Support
Computer based information resource to provide users with support for making decisions
Can help to standardize approaches to diagnosis, workup and treatment
Can also be used to individualize the process to the needs of different users
Computer based information resource to provide users with support for making decisions
Can help to standardize approaches to diagnosis, workup and treatment
Can also be used to individualize the process to the needs of different users
Goals inDecision Support
Goals inDecision Support
Improve patient knowledge base
Individualize information to each patient
Reduce clinicians’ knowledge deficit
Reduce effect of physician bias
Reduce patient distress and decisional regret
Improve patient knowledge base
Individualize information to each patient
Reduce clinicians’ knowledge deficit
Reduce effect of physician bias
Reduce patient distress and decisional regret
Advantages of Decision Support Tools*
Advantages of Decision Support Tools*
Help set tone and put patients at ease
Ensure essential information is transmitted
May be better than clinician: Reduce embarrassment Allow learning at comfortable pace Make it more effective time use when meeting
with clinician May more effectively engage in SDM
Help set tone and put patients at ease
Ensure essential information is transmitted
May be better than clinician: Reduce embarrassment Allow learning at comfortable pace Make it more effective time use when meeting
with clinician May more effectively engage in SDM
Green et al, Am J Med Genetics 2001* For genetic counseling
Decision Support and SDM in Breast CancerDecision Support and SDM in Breast Cancer
Multicenter phase III trial randomized 246 women <60 with breast cancer to: Standardized written materials Computer support at home
Both given before seeing MD
Patients surveyed 2 and 5 months later
Multicenter phase III trial randomized 246 women <60 with breast cancer to: Standardized written materials Computer support at home
Both given before seeing MD
Patients surveyed 2 and 5 months later
Gustafson et al, J Gen Intern Med 2001
Decision Support and SDM in Breast CancerDecision Support and SDM in Breast Cancer
At two months: Increased patient’s competence to deal with new
information Improved patient comfort in level of participation
in decision-making Increased confidence in MD
At five months: Enhanced patient’s information competence No difference in participation metrics
At two months: Increased patient’s competence to deal with new
information Improved patient comfort in level of participation
in decision-making Increased confidence in MD
At five months: Enhanced patient’s information competence No difference in participation metrics
Gustafson et al, J Gen Intern Med 2001
Computer support was particularly helpful for: Less educated Non-Caucasian Underinsured
Computer support was particularly helpful for: Less educated Non-Caucasian Underinsured
Gustafson et al, J Gen Intern Med 2001
Predictive Models in Breast Cancer
Predictive Models in Breast Cancer
Statistical methods of determining the most likely factors that predict a certain outcome
Statistical relationship doesn’t necessarily equal cause/effect relationship
Statistical methods of determining the most likely factors that predict a certain outcome
Statistical relationship doesn’t necessarily equal cause/effect relationship
Different Statistical ModelsDifferent Statistical Models
Risk group stratification
Nomograms
Artificial Neural Networks (ANN)
Classification and Regression Tree (CART)
Formulae
Risk group stratification
Nomograms
Artificial Neural Networks (ANN)
Classification and Regression Tree (CART)
Formulae
Not all statistical models give consistent results
Not all statistical models give consistent results
Mitchell et al, J Urol 2005
Individualized Decision Support
Individualized Decision Support
Provide clinician with evidence-based risk estimates
More helpful to cancer patients than standardized information
Interface can help optimize transmitting information by
Age Ethnicity, Language Education Psychological state Gender
Provide clinician with evidence-based risk estimates
More helpful to cancer patients than standardized information
Interface can help optimize transmitting information by
Age Ethnicity, Language Education Psychological state Gender
IBTR!IBTR!
Similar tool to Adjuvant! for determining risk of ipsilateral breast tumor recurrence after BCS
Included RCTs, meta-analyses and created composite estimate of 10-yr risk of LRR
Similar tool to Adjuvant! for determining risk of ipsilateral breast tumor recurrence after BCS
Included RCTs, meta-analyses and created composite estimate of 10-yr risk of LRR
IBTR!IBTR!
Includes data from RCTs, EBCTG
meta-analyses and single institution data
Variables included to calculate LR were: Age Tumor size Margin status LVI Grade Use of chemotherapy Use of hormonal therapy
Includes data from RCTs, EBCTG
meta-analyses and single institution data
Variables included to calculate LR were: Age Tumor size Margin status LVI Grade Use of chemotherapy Use of hormonal therapy
Sanghani et al, Am J Clin Oncol 2007
IBTR! ResultsIBTR! Results
MGH ValidationMGH Validation
Not enough women without RT to assess IBTR! estimates of no RT
Used IBTR! to estimate LRR in 1138 eligible women undergoing BCS and RT
Divided women into five risk groups: LRR <3% 3-5% 5.1-10% 10.1-20% >20%
Not enough women without RT to assess IBTR! estimates of no RT
Used IBTR! to estimate LRR in 1138 eligible women undergoing BCS and RT
Divided women into five risk groups: LRR <3% 3-5% 5.1-10% 10.1-20% >20% Sanghani et al, ASTRO 2008
Women with IBTR! estimates of <10% were accurate within 1%
Less accurate for Group 4 (4%) and Group 5 (7%) but still within 95% CI
Similar study from Vancouver demonstrated IBTR! reliable for low risk women, but overestimated LRR in <41, +margins or no RT
Women with IBTR! estimates of <10% were accurate within 1%
Less accurate for Group 4 (4%) and Group 5 (7%) but still within 95% CI
Similar study from Vancouver demonstrated IBTR! reliable for low risk women, but overestimated LRR in <41, +margins or no RT
Sanghani et al, ASTRO 2008Truong et al, ASTRO 2008
CaveatsCaveats
May not reflect more recently published research
Differences in patient population
May not include all the relevant variables
ER/PR/Her2-neu status Biomarkers
IBTR! limited to 10-Yr rates no comparison to mastectomy
May not reflect more recently published research
Differences in patient population
May not include all the relevant variables
ER/PR/Her2-neu status Biomarkers
IBTR! limited to 10-Yr rates no comparison to mastectomy
Will Decision SupportIncrease BCT Utilization?
Will Decision SupportIncrease BCT Utilization?
Use of decision support doesn’t guarantee favoring BCT
Uncertainty in best RT modality may be impediment to choosing BCT
Use of decision support doesn’t guarantee favoring BCT
Uncertainty in best RT modality may be impediment to choosing BCT
Prospective cohort of 125 BCS candidates seen at Dartmouth-Hitchcock Medical Center
Assessed for surgical choice, decisional conflict, values, knowledge, and decision role preference
Prospective cohort of 125 BCS candidates seen at Dartmouth-Hitchcock Medical Center
Assessed for surgical choice, decisional conflict, values, knowledge, and decision role preference
Collins et al, JCO 2009
>90% of women: Estimated 10-yr local failure after BCT Knew mastectomy and BCT had equal survival Had time to make a decision without an adverse
impact on survival
>90% of women: Estimated 10-yr local failure after BCT Knew mastectomy and BCT had equal survival Had time to make a decision without an adverse
impact on survival
Collins et al, JCO 2009
Treatment Choice Before DA After DA After Consult
Mastectomy 22% 31% 35%
Breast Conserving Surgery
34% 31% 65%
Uncertain 43% 38% --
Collins et al, JCO 2009
What factors influence decision for surgery?
What factors influence decision for surgery?
Collins et al, JCO 2009
Treatment Options in BCT:More is Less*
Treatment Options in BCT:More is Less*
More RT options may lead to: Sense of Knowledge Deficit Uncertainty Anxiety Distress Regret Dissatisfaction
Increasing the complexity of decision-making for BCT may increase mastectomy rates
More RT options may lead to: Sense of Knowledge Deficit Uncertainty Anxiety Distress Regret Dissatisfaction
Increasing the complexity of decision-making for BCT may increase mastectomy rates
* Barry Schwartz, The Paradox of Choice
SDM and Multidisciplinary Breast Cancer Care
SDM and Multidisciplinary Breast Cancer Care
Pros: Enhances specialist communication Increases patient confidence in “team” approach Improves patient’s efficiency in obtaining expert
opinions in a single visit
Cons: Information overload (? enough depth) May affect patient’s ability to assert a more active
decisional role Medico legal aspects
33% of MDs feels discussion environment is suboptimal 85% may disagree with MDM decision but 71% don’t voice it
Pros: Enhances specialist communication Increases patient confidence in “team” approach Improves patient’s efficiency in obtaining expert
opinions in a single visit
Cons: Information overload (? enough depth) May affect patient’s ability to assert a more active
decisional role Medico legal aspects
33% of MDs feels discussion environment is suboptimal 85% may disagree with MDM decision but 71% don’t voice it
Decision Support before Consultation?
Decision Support before Consultation?
Provide information resource to patients before meeting with clinician
Assess patient’s desired decisional role more accurately
Cognitive/psychological support to “prime” patient for SDM
Reduce decisional regret, improve patient’s cancer experience
Provide information resource to patients before meeting with clinician
Assess patient’s desired decisional role more accurately
Cognitive/psychological support to “prime” patient for SDM
Reduce decisional regret, improve patient’s cancer experience
ConclusionsConclusions
SDM has become increasingly important
Unmet patient needs when deciding between mastectomy and BCT
Patient’s perceived role is key to satisfaction and provider trust
We don’t always assess patient’s desired decisional role accurately
SDM has become increasingly important
Unmet patient needs when deciding between mastectomy and BCT
Patient’s perceived role is key to satisfaction and provider trust
We don’t always assess patient’s desired decisional role accurately
ConclusionsConclusions
Better doctor-patient communication can reduce distress and decisional regret
Decision support can facilitate SDM for patient-clinician dyad
Effective SDM is a more important goal than BCT rates
Adjuvant! and IBTR! are just the beginning
Better doctor-patient communication can reduce distress and decisional regret
Decision support can facilitate SDM for patient-clinician dyad
Effective SDM is a more important goal than BCT rates
Adjuvant! and IBTR! are just the beginning
AcknowledgementsAcknowledgements
Julie Jones, MD
Alphonse Taghian, MGH
David Wazer, Tufts Medical Ctr.
Julie Jones, MD
Alphonse Taghian, MGH
David Wazer, Tufts Medical Ctr.