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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK111987 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach.
A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Utilization of Decision Aid Website | Experimental | All enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid Website | Other | The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eligible Parents Screened (Feasibility) | Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100. | Baseline (T1) |
| Percent of Eligible Parents Enrolled (Feasibility) | The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100. | Baseline (T1) |
| Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) | Acceptability of a decision aid refers to ratings regarding the comprehensibility of components of a decision aid, its length, clarity, amount of information, and balance in presentation of information about options. The tool has 4 questions with answers on a Likert scale ranging from 1-5 (length, amount of information, and balance) and 1-4 (clarity). A response of 3 is ideal for information, length, and balance and a response of 1 is ideal for clarity. | Pre-consultation, 1 week after baseline (T2) |
| Percentage of Parents Retained in the Study (Feasibility) | Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100. | T1 to T4, a total of approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Decisional Conflict Scale (DCS) Score at T1 and T2 | The Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. This study utilizes the full version, a Likert-type scale consisting of 16 questions and answer options of strongly agree to strongly disagree. Total scores range from 0-100, a higher score means more decisional conflict. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Hubert Chan, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| UNC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parent Utilization of Decision Aid Website | All enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist. Decision Aid Website: The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Parent Utilization of Decision Aid Website | All enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist. Decision Aid Website: The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent of Eligible Parents Screened (Feasibility) | Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100. | All available data are reported. Data reported for parents who were screened for eligibility. | Posted | Number | percentage of parents recruited | Baseline (T1) |
|
From enrollment through study completion. Enrollment occured from 1 week up to 6 months before the initial urology visit through. Study completion occurred approximately 3 months post urology visit if no surgery or 6 months post surgery.
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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 | Parent Utilization of Decision Aid Website | All enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist. Decision Aid Website: The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine Cuevas | Indiana University | 317-278-7495 | elinder@iu.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 | Jul 24, 2023 | Aug 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2021 | Feb 14, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
| Mean Decisional Conflict Scale (DCS) Score at T2 and T3 | The Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. This study utilizes the full version, a Likert-type scale consisting of 16 questions and answer options of strongly agree to strongly disagree. Total scores range from 0-100, a higher score means more decisional conflict. Time frame revised to address original entry error. | Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3) |
| Mean Decision-Specific Knowledge Scores | Decision-Specific Knowledge is a six-question tool with multiple choice question and answer options created by the investigator to measure pre/post knowledge of hypospadias and repair surgery. Total scores range from 0-100% with a higher score indicating more correct answers. | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
| Mean Decisional Regret Scale Score | The Decision Regret Scale measures distress or remorse after a decision. Brehaut's (2003) 5-item scale has scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret. | 3-month post-consultation (T4) |
| Hypospadias Treatment Preference by Category at T1 and T2 | This is a single question created by the investigator asking "Do you intend for your son to have hypospadias surgery?" with yes/no/unsure answer options to measure a change in response, or not, after viewing the decision aid website. | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
| Hypospadias Treatment Preference by Category at T2 and T3 | This is a single question created by the investigator asking "Do you intend for your son to have hypospadias surgery?" with yes/no/unsure answer options to measure a change in response, or not, after viewing the decision aid website. | Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3) |
| Awareness of Decision by Category at T1 and T2 | This is a single question created by the investigator asking "Is there a decision to make about whether your son should have surgery for his hypospadias?" with yes/no/unsure answer options to measure a change in awareness of decision, or not, after viewing the decision aid website. | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
| Awareness of Decision by Category at T2 and T3 | This is a single question created by the investigator asking "Is there a decision to make about whether your son should have surgery for his hypospadias?" with yes/no/unsure answer options to measure a change in awareness of decision, or not, after viewing the decision aid website. | Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3) |
| Mean Shared Decision Making Questionnaire Score | The Shared Decision Making Questionnaire measures the decisional process in medical encounters from both the patient and the physician perspectives. The questionnaire contains 9 questions with answers on a 6-point Likert scale. Scores range from 0-100 with higher scores indicating a higher perceived level of shared decision making. | Initial post-consultation, within 48 hours of urology visit (T3) |
| Mean Preparation for Decision Making Score | The Preparation for Decision Making scale (Prep-DM) scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. The scale contains 10 questions with answers on a Likert Scale Scores range from 0-100 with higher scores indicating a higher perceived level of preparation for decision making. | Pre-consultation, 1 week after baseline (T2) |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| 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 | Count of Participants | Participants |
|
| Child's Age at Consent | Mean | Standard Deviation | days |
|
| Child's Meatal Location (Confirmed hypospadias) | Only 30 children were diagnosed with hypospadias at the consultation with the urologist. | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Health Insurance | Count of Participants | Participants |
|
| Health Literacy | Participants were asked: "How often do you need to have someone help you when you read instruction, pamphlets, or other written material from your doctor or pharmacy?" | Count of Participants | Participants |
|
| Mean Income by Zip Code | Mean | Standard Deviation | dollars annually |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percent of Eligible Parents Enrolled (Feasibility) | The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100. | All available data are reported. Data reported for eligible parents. | Posted | Number | percentage of parents enrolled | Baseline (T1) |
|
|
|
| Primary | Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) | Acceptability of a decision aid refers to ratings regarding the comprehensibility of components of a decision aid, its length, clarity, amount of information, and balance in presentation of information about options. The tool has 4 questions with answers on a Likert scale ranging from 1-5 (length, amount of information, and balance) and 1-4 (clarity). A response of 3 is ideal for information, length, and balance and a response of 1 is ideal for clarity. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. | Posted | Count of Participants | Participants | Pre-consultation, 1 week after baseline (T2) |
|
|
|
| Primary | Percentage of Parents Retained in the Study (Feasibility) | Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100. | All available data are reported. Of the 64 parents who completed T1, 9 were lost to follow up and 1 withdrew. Of the 54 who completed T2, 1 parent was lost to follow up before the consultation. Of the 53 completing the consultation, 23 were found to not to have hypospadias. Of the 30 patients diagnosed with hypospadias, 1 parent was lost to follow up prior to T3. Of the 29 parents who completed T3, 2 parents were lost to follow up prior to T4 resulting in a total of 27 parents who completed T4. | Posted | Number | percentage of participants | T1 to T4, a total of approximately 6 months |
|
|
|
| Secondary | Mean Decisional Conflict Scale (DCS) Score at T1 and T2 | The Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. This study utilizes the full version, a Likert-type scale consisting of 16 questions and answer options of strongly agree to strongly disagree. Total scores range from 0-100, a higher score means more decisional conflict. | All available data are reported. Data reported includes participants who completed the Decisional Conflict Scale for T1, T2, and T3. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
|
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| Secondary | Mean Decisional Conflict Scale (DCS) Score at T2 and T3 | The Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. This study utilizes the full version, a Likert-type scale consisting of 16 questions and answer options of strongly agree to strongly disagree. Total scores range from 0-100, a higher score means more decisional conflict. Time frame revised to address original entry error. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. Of the 53 who completed the consultation, 23 were found to not to have hypospadias and were discontinued. One parent was lost to follow up during T3, resulting in 29. | Posted | Mean | Standard Deviation | score on a scale | Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3) |
|
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| Secondary | Mean Decision-Specific Knowledge Scores | Decision-Specific Knowledge is a six-question tool with multiple choice question and answer options created by the investigator to measure pre/post knowledge of hypospadias and repair surgery. Total scores range from 0-100% with a higher score indicating more correct answers. | All available data are reported. 64 participants completed the baseline decision-specific knowledge quiz but 10 did not complete the pre-clinic decision-specific knowledge quiz. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study. Scores are reported for 54 participants who completed the baseline and pre-clinic decision-specific knowledge quiz. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
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| Secondary | Mean Decisional Regret Scale Score | The Decision Regret Scale measures distress or remorse after a decision. Brehaut's (2003) 5-item scale has scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up during T3. Two parents were lost to follow up between T3 and T4 totaling 27. | Posted | Mean | Standard Deviation | score on a scale | 3-month post-consultation (T4) |
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| Secondary | Hypospadias Treatment Preference by Category at T1 and T2 | This is a single question created by the investigator asking "Do you intend for your son to have hypospadias surgery?" with yes/no/unsure answer options to measure a change in response, or not, after viewing the decision aid website. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. | Posted | Count of Participants | Participants | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
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| Secondary | Hypospadias Treatment Preference by Category at T2 and T3 | This is a single question created by the investigator asking "Do you intend for your son to have hypospadias surgery?" with yes/no/unsure answer options to measure a change in response, or not, after viewing the decision aid website. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up during T3. | Posted | Count of Participants | Participants | Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3) |
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| Secondary | Awareness of Decision by Category at T1 and T2 | This is a single question created by the investigator asking "Is there a decision to make about whether your son should have surgery for his hypospadias?" with yes/no/unsure answer options to measure a change in awareness of decision, or not, after viewing the decision aid website. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. | Posted | Count of Participants | Participants | Baseline (T1), Pre-consultation, 1 week after baseline (T2) |
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| Secondary | Awareness of Decision by Category at T2 and T3 | This is a single question created by the investigator asking "Is there a decision to make about whether your son should have surgery for his hypospadias?" with yes/no/unsure answer options to measure a change in awareness of decision, or not, after viewing the decision aid website. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up during T3. | Posted | Count of Participants | Participants | Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3) |
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| Secondary | Mean Shared Decision Making Questionnaire Score | The Shared Decision Making Questionnaire measures the decisional process in medical encounters from both the patient and the physician perspectives. The questionnaire contains 9 questions with answers on a 6-point Likert scale. Scores range from 0-100 with higher scores indicating a higher perceived level of shared decision making. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up before T3, resulting in 29 parents. | Posted | Mean | Standard Deviation | score on a scale | Initial post-consultation, within 48 hours of urology visit (T3) |
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| Secondary | Mean Preparation for Decision Making Score | The Preparation for Decision Making scale (Prep-DM) scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. The scale contains 10 questions with answers on a Likert Scale Scores range from 0-100 with higher scores indicating a higher perceived level of preparation for decision making. | All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. | Posted | Mean | Standard Deviation | score on a scale | Pre-consultation, 1 week after baseline (T2) |
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| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
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| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|
| Information : A little more than wanted |
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| Information : Much more than wanted |
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| Length: Much too long |
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| Length: A little too long |
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| Length: About right |
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| Length: A little too short |
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| Length: Much too short |
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| Clarity: Everything was clear |
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| Clarity: Most things were clear |
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| Clarity: Some things were clear |
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| Clarity: Many things were unclear |
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| Balance: Clearly slanted to surgery |
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| Balance: Slightly slanted to surgery |
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| Balance: Completely balanced |
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| Balance: Slightly slanted to no surgery |
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| Balance: Clearly slanted to no surgery |
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| Unsure |
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| T2 |
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| Unsure |
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| T3 |
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| Unsure |
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| T2 |
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| Unsure |
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| T3 |
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