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| ID | Type | Description | Link |
|---|---|---|---|
| K23NR018672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This mixed-methods, two-arm, randomized controlled trial will evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health & Science University Internal Medicine and Geriatrics Clinic provided over 12 months.
The goal of this mixed-methods, two-arm, randomized controlled trial of MI intervention for fall prevention is to evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health & Science University Internal Medicine and Geriatrics Clinic provided over 12-months. Older adult participants (older than 65) who are at increased risk for falling will be enrolled into the study. Patients will be randomly assigned to two groups: MI and the standard of care group. All participants will have a baseline and 6-months study visit that will include self-report and physiologic assessment. In addition, all participants will receive study measurement phone call at 3-, and 12-months. MI will be provided via video, phone, or in-person one week after the initial visit and then monthly for 6 months. All MI sessions will be recorded and encounter notes will be completed. Purposefully selected participants' MI sessions will be transcribed for qualitative analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing (MI) goup | Experimental | The MI experimental group will receive the same measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change. |
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| Control group | No Intervention | The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | The PI and two study staff members (interventionists) will conduct study visits and phone calls. The same person will complete participant follow-ups to establish rapport and consistency. All of the study encounters will be audio recorded with participants' permission and study encounter notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify a specific fall prevention behavior, the participant's goal with this behavior, readiness to change, specific plan to move toward the goal, barriers and facilitators, and the participant's commitment level to change. |
| Measure | Description | Time Frame |
|---|---|---|
| Falls Self-Efficacy Scale-International (FES-I) Results | A 7-item scale, 1-4 self-report rating, widely used to measure levels of concern related to preventing falls. Minimum value is 7 and maximum value is 28. Higher FES-I scores is a worse value since it has been positively correlated with decreased activities, future falls, and injury. | 3-, 6-, and 12-months |
| Fall Behavioral (FAB) Scale Results | A 24-item, 1-4 self-report rating to measure frequency of protective strategies to prevent falling and risky behaviors that facilitate a fall. The average value is calculated with a minimum value of 1 and maximum value of 4. Higher FAB score is a better value since it indicates more consistent fall protective behaviors. | 3-, 6-, and 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure Results | 100-point, quantifiable scale determining patient engagement in healthcare. Minimum value is 0 and the maximum value is 100. Higher value is a better value since it is indicative of participant's activation with their healthcare. | 3-, 6-, and 12-months |
| Level of Confidence to Prevent Falls |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroko Kiyoshi-Teo, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing (MI) Group | The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change. |
| FG001 | Control Group | The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing (MI) Group | The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change. Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Falls Self-Efficacy Scale-International (FES-I) Results | A 7-item scale, 1-4 self-report rating, widely used to measure levels of concern related to preventing falls. Minimum value is 7 and maximum value is 28. Higher FES-I scores is a worse value since it has been positively correlated with decreased activities, future falls, and injury. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | units on a scale | 3-, 6-, and 12-months |
|
12-months
Fall data were collected systematically via monthly fall calendar. Other adverse events were collected in non-systematic, opportunistic ways.
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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 | Motivational Interviewing (MI) Group | The MI experimental group will take part in the same study measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions within 6-months. MI is an evidence-based communication approach for various health behavior change. Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls (major) | Injury, poisoning and procedural complications | Systematic Assessment | Falls (major): Falls that result in hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | Injury, poisoning and procedural complications | Non-systematic Assessment | Falls |
Study enrollment & data collection were conducted during the COVID-19 pandemic in Oregon.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hiroko Kiyoshi-Teo (Assistant Professor) | Oregon Health & Science University | 5034943858 | kiyoshi@ohsu.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 19, 2023 | May 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2021 | May 14, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of confidence are known to be associated with an increased rate of behavior change. |
| 3-, 6-, and 12-months |
| Level of Importance to Prevent Falls | 1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of importance are known to be associated with an increased rate of behavior change. | 3-, 6-, and 12-months |
| Balance Measure (Feet Side by Side) | Duration that participants can hold feet side-by-side stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance. | 6- months |
| Balance Measure (Semi-tandem Stand) | Duration that participants can hold semi-tandem stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance. | 6- months |
| Balance Measure (Tandem Stand) | Individuals are asked to hold a tandem stand (one foot in front of the other- heel touching toe). The minimum is 0 and the maximum is 10. A higher number is a better outcome. | 6-months |
| Balance Measure (One-leg Stand) | Individuals are asked to hold a balance position for 10 sections without moving their feet or needing support. This position require standing on one foot. The minimum is 0 and the maximum is 10. A higher number is a better outcome. | 6- months |
| 30-second Sit-to-stand Assessment | Instances that participants can stand from a sitting position will be measured. Minimum value is 0 times. Higher value is a better value since it is indicative of participants' ability to sit-to-stand. | 6-months |
| Number of Participants With Self-reported Falls | Individuals were asked to mail-in reports of falls every month. Participants reporting a fall at least once are counted as a faller. Minimum value is 0. Higher value is worse value as it is indicative that there were more participants who fell during the year. | 1-year |
| Death |
|
| BG001 | Control Group | The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Balance Measure | Individuals are asked to hold progressively challenging balance position for 10 sections without moving their feet or needing support. The positions are standing with feet side-by-side, semi-tandem (instep of one foot is touching big toe of the other foot), tandem stand (one foot in front of the other- heel touching toe), and stand on one foot. The minimum is 0 and the maximum is 10. A higher number is a better outcome. | Some participants were unable to complete the physical function assessments which are secondary measures because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB). | Mean | Standard Deviation | units on a scale |
|
| Fall Efficacy Scale International- Short | A 7-item scale widely used to measure levels of concern related to preventing falls while doing certain activities. Individuals self-report their concern from not at all concerned (1) to very concerned (4). Minimum value is 7 and maximum value is 28. Higher FES-I scores is a worse value since it has been positively correlated with decreased activities, future falls, and injury. | Mean | Standard Deviation | units on a scale |
|
| Patient Activation Measure | A 10-item survey that assesses an individual's knowledge, skills, and confidence to manage one's own health and healthcare. There is an algorithm for scoring on a scale from 0 to 100 that corresponds to one of four levels of patient activation. A score of 0/level 1 is disengaged and overwhelmed and a score of 100/level 4 is maintaining behaviors. A higher score is a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Falls Behavioral Scale | A list of 30 statements that describes everyday things with a rating from never (1) to always (4) in how often they do each task. The average is taken for a minimum of 0 and maximum of 4. The higher score is a better outcome. | Mean | Standard Deviation | units on a scale |
|
| 30-second Sit-to-Stand | Test leg strength and endurance using a chair with a straight back without arm rests. Individuals are asked to sit in the middle of the chair, place hands on opposite shoulders crossed at the wrists, keep feet flat on the floor, and keep back straight and arms against chest. They are asked to rise to a full standing position and sit back down again for 30 seconds. The number of times an individual comes to a full standing position in 30 seconds is the outcome. Scores range by sex and age-group. For 65-69 year old men, the below average score is under 12 and women is under 11. Higher is better. | Some participants were unable to complete the physical function assessments which are secondary measures (4-stage balance test and 30-second sit-to-stand) because of their inability to operate the video call despite study staff's support, or because of infection concerns related to COVID to have a supportive personnel near by (requirement from OHSU IRB). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Group | The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit. |
|
|
|
| Primary | Fall Behavioral (FAB) Scale Results | A 24-item, 1-4 self-report rating to measure frequency of protective strategies to prevent falling and risky behaviors that facilitate a fall. The average value is calculated with a minimum value of 1 and maximum value of 4. Higher FAB score is a better value since it indicates more consistent fall protective behaviors. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from the participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | units on a scale | 3-, 6-, and 12-months |
|
|
|
| Secondary | Patient Activation Measure Results | 100-point, quantifiable scale determining patient engagement in healthcare. Minimum value is 0 and the maximum value is 100. Higher value is a better value since it is indicative of participant's activation with their healthcare. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | score on a scale | 3-, 6-, and 12-months |
|
|
|
| Secondary | Level of Confidence to Prevent Falls | 1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of confidence are known to be associated with an increased rate of behavior change. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | units on a scale | 3-, 6-, and 12-months |
|
|
|
| Secondary | Level of Importance to Prevent Falls | 1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of importance are known to be associated with an increased rate of behavior change. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | units on a scale | 3-, 6-, and 12-months |
|
|
|
| Secondary | Balance Measure (Feet Side by Side) | Duration that participants can hold feet side-by-side stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | seconds | 6- months |
|
|
|
| Secondary | Balance Measure (Semi-tandem Stand) | Duration that participants can hold semi-tandem stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance. | The number analyzed differed by time point because of the loss to follow-up and participant withdrawal as indicated in the participant flow data, and participants' willingness and ability to participate in the measurements. | Posted | Mean | Standard Deviation | seconds | 6- months |
|
|
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| Secondary | Balance Measure (Tandem Stand) | Individuals are asked to hold a tandem stand (one foot in front of the other- heel touching toe). The minimum is 0 and the maximum is 10. A higher number is a better outcome. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | units on a scale | 6-months |
|
|
|
| Secondary | Balance Measure (One-leg Stand) | Individuals are asked to hold a balance position for 10 sections without moving their feet or needing support. This position require standing on one foot. The minimum is 0 and the maximum is 10. A higher number is a better outcome. | We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.) | Posted | Mean | Standard Error | seconds | 6- months |
|
|
|
| Secondary | 30-second Sit-to-stand Assessment | Instances that participants can stand from a sitting position will be measured. Minimum value is 0 times. Higher value is a better value since it is indicative of participants' ability to sit-to-stand. | Some participants were unable to complete the physical assessment due to physical limitations, access to a video platform, or a support person. | Posted | Mean | Standard Deviation | units on a scale | 6-months |
|
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| Secondary | Number of Participants With Self-reported Falls | Individuals were asked to mail-in reports of falls every month. Participants reporting a fall at least once are counted as a faller. Minimum value is 0. Higher value is worse value as it is indicative that there were more participants who fell during the year. | One participant in the MI group had an unreliable reporting of falls due to his unstable memory (ID 1277). Based on the discussion with the Safety Monitoring Council, his data was considered an outlier and removed from the analysis. | Posted | Count of Participants | Participants | 1-year |
|
|
|
| 2 |
| 101 |
| 11 |
| 101 |
| 54 |
| 101 |
| EG001 | Control Group | The control group participants will take part in study measurements and routine clinical care. | 2 | 99 | 13 | 99 | 62 | 99 |
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| Death | Metabolism and nutrition disorders | Non-systematic Assessment | Death |
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| Hip surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Hip Surgery |
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| Orthostatic hypotension | Vascular disorders | Non-systematic Assessment | Orthostatic hypotension |
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| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment | Inguinal hernia |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | Urinary tract infection |
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| Heart surgery | Vascular disorders | Non-systematic Assessment | Heart surgery |
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| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | Bowel obstruction |
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| Skiing injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Skiing injury |
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| Neurosurgery | Nervous system disorders | Non-systematic Assessment | Neurosurgery |
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| COVID | Infections and infestations | Non-systematic Assessment | COVID |
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| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment | Deep vein thrombosis |
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| Car/bike accident | Injury, poisoning and procedural complications | Non-systematic Assessment | Car/bike accident |
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| Shunt | Eye disorders | Non-systematic Assessment | Shunt in right eye |
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| Hammer toe | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Hammer toe |
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| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | R Leg pain |
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| Bladder infection | Renal and urinary disorders | Non-systematic Assessment | Bladder infection |
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| Gut pain | Gastrointestinal disorders | Non-systematic Assessment | Gut pain |
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| Cancer removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Cancer removal |
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| Rotator cuff surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Rotator cuff surgery |
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| Nose surgery | Ear and labyrinth disorders | Non-systematic Assessment | Nose surgery |
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| Headaches | Nervous system disorders | Non-systematic Assessment | Headaches |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 12-months |
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| 12-months |
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| 12-months |
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| 12-months |
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