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| ID | Type | Description | Link |
|---|---|---|---|
| R18HS026699 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure. The risk of complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. It was modified with extensive stakeholder input and built to be incorporated into electronic health records and patient portals. This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at improving the quality of reconstruction decisions.
Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched to test the workflow and procedures. The investigators plan to recruit up to 20 patients, continuing until procedures are smooth and ready for the randomized trial. The investigators will follow these same procedures as the trial, other than randomization, to test the workflow and tool use programming.
For the RCT, patients considering mastectomy at academic and community practices (n=340) will be randomized over 18 months to use BREASTChoice or a control website.
After the patient participant consents to be in the study, they will be randomized (using computer random assignment) participants to view the clinical decision support tool, BREASTChoice or the attention control website, using block randomization (block size of 2 and 4). Depending on the clinic work-flow, the patients may be sent the link to the tool or control website: 1) by email or MyChart message, prior to their visit with the plastic or reconstruction surgeon, for them to complete from home or in the waiting room (ideal and preferred approach); 2) by email or MyChart, in person or virtually at the time of their plastic or reconstruction visit, for patients that have same-day breast surgeon and plastic reconstruction surgeon visits, with time to wait in between appointments; or 3) by email or MyChart, after the plastic surgery appointment, if they have not yet made a decision about reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or they want or need more time to decide on their surgery choices). Participants will be sent the link via MyChart unless they do not have a MyChart account. In that case, they will be sent the link via email. Study staff will be available to answer questions about MyChart via phone or email.
BREASTChoice is interactive with multiple modules. It starts with facts about breast reconstruction. Modules describe pros and cons of reconstruction, reconstruction timing, and reconstruction types. When discussing reconstruction timing, a risk prediction model pulls health data from the EHR (asking patients information in the model that is missing) to personalize risk of complications from immediate breast reconstruction. It also shows average risks for mastectomy alone and mastectomy plus immediate breast reconstruction so women can compare their personalized risk to average risks. Each module contains real patient quotes, a section called "Let's review" which checks patients' understanding, and "What matters to you", which elicits patients' preferences. Diverse patient photos and outcomes are provided. It is written at a 7th grade reading level. Data on patients' risks and a summary of her preferences are sent to their plastic/reconstructive surgeon to view in the electronic health record. The tool takes the patient about 20minutes to complete.
Control Website: The investigators chose an attention control, rather than usual care, to reduce differences between arms in participant expectation of benefit. Those in the control arm will get a link to an NCI website about breast reconstruction. That website includes 10 sections with information about types of breast reconstruction, timing, recovery, risks, cancer surveillance and additional resources. The website provides information, but does not include values clarification or tailored risk information. It is not interactive and does not include photos..
(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BREASTChoice | Experimental |
|
|
| Attention Control Website | Active Comparator |
|
|
| Clinicians | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Reconstruction Education and Support Tool (BREASTChoice) | Other | The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge as Measured by Decision Quality Instrument | -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A value of 1 is given for each correct answer and a value of 0 is given for each incorrect answer. An overall knowledge score is calculated for each patient by dividing the number of correct responses (range 0-9) by 9 to be re-scaled from 0-100. Higher values indicate higher knowledge. | After initial visit but before surgery, estimated to be before day 7 |
| Preference Concordance |
| Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR |
| Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict | -The validated, widely-used SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) Measure of Decisional Conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict; the outcome is binary indicating a score of 4 (no decisional conflict) vs. ≤3 (presence of decisional conflict). |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction | -Participants will be considered high-risk if their risk exceeds two times the population average | After patient participation (approximately 18 months) |
| Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria for Clinicians:
-Clinicians who provide breast cancer care within the plastic and reconstructive surgery at Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who provide care for patients considering breast reconstruction after mastectomy
Exclusion Criteria for Clinicians:
-Plastic and reconstructive clinicians working at other breast clinic locations, and surgeons who do provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Mary Politi, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Clara Lee, M.D., MPP | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| The Ohio State University Wexner Medical Center |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BREASTChoice |
|
| FG001 | Attention Control Website |
|
| FG002 | Clinicians |
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The overall number of baseline participants in the BREASTChoice arm do not include the 3 participants who were accidently randomized. The overall number of participants in the Attention Control Website arm does not include the 1 participant who was accidently randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | BREASTChoice |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age was not collected on Clinicians. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knowledge as Measured by Decision Quality Instrument | -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A value of 1 is given for each correct answer and a value of 0 is given for each incorrect answer. An overall knowledge score is calculated for each patient by dividing the number of correct responses (range 0-9) by 9 to be re-scaled from 0-100. Higher values indicate higher knowledge. | Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians. | Posted | Median | Inter-Quartile Range | score on a scale | After initial visit but before surgery, estimated to be before day 7 |
|
Adverse events and all-cause mortality were collected through study completion (an average of 18 months).
Adverse events and all-cause mortality were not collected on Clinicians.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BREASTChoice |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Politi, Ph.D. | Washington University School of Medicine | 314-747-1967 | mpoliti@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 | Jul 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2023 | Jun 29, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
|
| Attention Control Website | Other |
|
| Clinician Survey | Other | -Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making. |
|
| After initial visit but before surgery, estimated to be before day 7 |
-The Continuing Professional Development (CPD) Reaction scale is a 12-item measure with each item having a scale of 1-7. These 12 items correspond to the following 5 constructs (2-3 items per construct) are assessed: intention (2 items), social influence (3 items), beliefs about capabilities (3 items), moral norm (2 items), and beliefs about consequence (2 items). The possible scale range is 1-7. Higher values or a positive change indicates higher intention, social influence, beliefs about capabilities, moral norm, or beliefs about consequences of engaging in shared decision making. Each scale is reported as an average. **For clinician arm only |
| Assessed pre- and post-study (approximately 24 months) |
| Knowledge as Measured by Knowledge Questions Developed in Previous Studies | -This is a an 11-item measure using true/false/unsure response options. A knowledge score is calculated by dividing the number of correct responses (each scored 1 if correct, 0 if incorrect, unsure, or blank) by the number of knowledge items (11), to be re-scaled to 0-100. Higher values indicate higher knowledge. | After initial visit but before surgery, estimated before day 7 |
| Consult Time as Measured by Time Spent With Clinician During the Visit | -Consult time using the BREASTChoice will be compared to consult using the attention control. | Initial visit (day 1) |
| Usability as Measured by the System Usability Scale (SUS) | -The System Usability Index (SUS) is a 10-item measure (each scaled 1-5) of how easy a website is to use. It is asked of only those in the BreastChoice group to assess the usability of tool. A usability score is calculated by adding the items and multiplying the sum by 2.5. Usability scores can range from 0-100 with higher scores indicating greater usability. A score greater than 68 indicates adequate usability. | After initial visit but before surgery, estimated to be before day 7 |
| Knowledge as Measured by Decision Quality Instrument | -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items. Value of 1 given for each correct answer and value of 0 for each incorrect answer. Overall knowledge score range is 0-9 re-scaled from 0-100. | After initial visit but before surgery, estimated to be before day 7 |
| Preference Concordance as Measured by the Decision Quality Instrument |
| Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR |
| Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict | -The validated, widely-used SURE measure of decisional conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict. | After initial visit but before surgery, estimated to be before day 7 |
| Columbus |
| Ohio |
| 43210 |
| United States |
| BG001 | Attention Control Website |
|
| BG002 | Clinicians |
|
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Age was not collected on Clinicians. | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Breast cancer stage |
| This data was not collected on Clinicians. | Count of Participants | Participants |
|
| Annual household income | There are participants excluded because they skipped the income question. | This data was not collected on Clinicians. | Count of Participants | Participants |
|
| Educational attainment | Count of Participants | Participants |
|
| OG001 | Attention Control Website |
|
| OG002 | Clinicians |
|
|
|
|
| Primary | Preference Concordance |
| Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians. | Posted | Count of Participants | Participants | Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR |
|
|
|
|
| Primary | Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict | -The validated, widely-used SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) Measure of Decisional Conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict; the outcome is binary indicating a score of 4 (no decisional conflict) vs. ≤3 (presence of decisional conflict). | Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians. | Posted | Count of Participants | Participants | After initial visit but before surgery, estimated to be before day 7 |
|
|
|
|
| Secondary | Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction | -Participants will be considered high-risk if their risk exceeds two times the population average | Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians. | Posted | Count of Participants | Participants | After patient participation (approximately 18 months) |
|
|
|
|
| Secondary | Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale | -The Continuing Professional Development (CPD) Reaction scale is a 12-item measure with each item having a scale of 1-7. These 12 items correspond to the following 5 constructs (2-3 items per construct) are assessed: intention (2 items), social influence (3 items), beliefs about capabilities (3 items), moral norm (2 items), and beliefs about consequence (2 items). The possible scale range is 1-7. Higher values or a positive change indicates higher intention, social influence, beliefs about capabilities, moral norm, or beliefs about consequences of engaging in shared decision making. Each scale is reported as an average. **For clinician arm only | This outcome measure is for Clinicians only. | Posted | Mean | Standard Deviation | score on a scale | Assessed pre- and post-study (approximately 24 months) |
|
|
|
|
| Secondary | Knowledge as Measured by Knowledge Questions Developed in Previous Studies | -This is a an 11-item measure using true/false/unsure response options. A knowledge score is calculated by dividing the number of correct responses (each scored 1 if correct, 0 if incorrect, unsure, or blank) by the number of knowledge items (11), to be re-scaled to 0-100. Higher values indicate higher knowledge. | Overall number of participants analyzed include those in the intent to treat analysis. Data for this outcome measure was not collected on Clinicians. | Posted | Mean | Standard Deviation | score on a scale | After initial visit but before surgery, estimated before day 7 |
|
|
|
|
| Secondary | Consult Time as Measured by Time Spent With Clinician During the Visit | -Consult time using the BREASTChoice will be compared to consult using the attention control. | The data for this outcome measure was not collected. | Posted | Initial visit (day 1) |
|
|
| Secondary | Usability as Measured by the System Usability Scale (SUS) | -The System Usability Index (SUS) is a 10-item measure (each scaled 1-5) of how easy a website is to use. It is asked of only those in the BreastChoice group to assess the usability of tool. A usability score is calculated by adding the items and multiplying the sum by 2.5. Usability scores can range from 0-100 with higher scores indicating greater usability. A score greater than 68 indicates adequate usability. | Only participants in the BREASTChoice arm were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | After initial visit but before surgery, estimated to be before day 7 |
|
|
|
|
| Secondary | Knowledge as Measured by Decision Quality Instrument | -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items. Value of 1 given for each correct answer and value of 0 for each incorrect answer. Overall knowledge score range is 0-9 re-scaled from 0-100. | For this analysis, BREASTChoice participants who never accessed the tool were excluded. Data for this outcome measure was not collected on Clinicians. | Posted | Median | Inter-Quartile Range | score on a scale | After initial visit but before surgery, estimated to be before day 7 |
|
|
|
|
| Secondary | Preference Concordance as Measured by the Decision Quality Instrument |
| For this analysis, BREASTChoice participants who never accessed the tool were excluded. Data for this outcome measure was not collected on Clinicians. | Posted | Count of Participants | Participants | Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR |
|
|
|
|
| Secondary | Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict | -The validated, widely-used SURE measure of decisional conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict. | For this analysis, BREASTChoice participants who never accessed the tool were excluded. If participants did not answer the questions, they were also excluded. Data for this outcome measure was not collected on Clinicians. | Posted | Count of Participants | Participants | After initial visit but before surgery, estimated to be before day 7 |
|
|
|
|
| Secondary | Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction | -Participants will be considered high-risk if their risk exceeds two times the population average | Only high risk participants are included in this outcome measure. Data for this outcome measure was not collected on Clinicians. | Posted | Count of Participants | Participants | After patient participation (approximately 18 months) |
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|
|
| 0 |
| 156 |
| 0 |
| 156 |
| 0 |
| 156 |
| EG001 | Attention Control Website |
| 1 | 165 | 0 | 165 | 0 | 165 |
| EG002 | Clinicians |
| 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Treatment does not match preference |
|
| Excluded |
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| Immediate reconstruction versus delayed reconstruction |
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| Flap reconstruction versus Implant reconstruction |
|
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| Superiority |
Immediate reconstruction versus delayed reconstruction |
| Flap reconstruction versus Implant reconstruction | Fisher Exact | 0.6178 | Superiority |
| Intention (Post-Study) |
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| Social influence (Pre-Study) |
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| Social influence (Post-Study) |
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| Beliefs about capabilities (Pre-Study) |
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| Beliefs about capabilities (Post-Study) |
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| Moral norm (Pre-Study) |
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| Moral norm (Post-Study) |
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| Beliefs about consequences (Pre-Study) |
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| Beliefs about consequences (Post-Study) |
|
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| Treatment does not match preference |
|
| Excluded |
|
| Immediate reconstruction versus delayed reconstruction |
|
|
| Flap reconstruction versus Implant reconstruction |
|
|
| 0.510 |
| Superiority |
| Flap reconstruction versus Implant reconstruction | Fisher Exact | 0.469 | Superiority |