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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| University of California, San Diego | OTHER |
| Albert Einstein College of Medicine | OTHER |
| University of Massachusetts, Worcester |
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Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).
The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. |
|
| Usual Care | Active Comparator | This arm will receive usual care for pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture for pain management | Procedure | A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Recruitment of Participants Into the Study. | The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site. | At Enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Retained in the Study at Post Treatment | Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. | At post treatment (45-60 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery A Dusek, PhD | University California-Irvine | Principal Investigator |
| M. Diane McKee, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| Einstein School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39640074 | Derived | Dusek JA, Kallenberg GA, Storrow AB, Hughes RM, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, Faryar KA, Dyer NL, Barton BA, McKee MD. Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial. Integr Med Res. 2024 Dec;13(4):101095. doi: 10.1016/j.imr.2024.101095. Epub 2024 Oct 21. | |
| 38841077 | Derived | Nielsen A, Dyer NL, Lechuga C, McKee MD, Dusek JA. Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines. Integr Med Res. 2024 Jun;13(2):101048. doi: 10.1016/j.imr.2024.101048. Epub 2024 May 10. |
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At the moment of consent,165 patients were randomized to group. However, 14 (7 per group) did not provide outcomes as detailed below. Complete participants were 151 at Post-Treatment.
A sample of ED providers at the sites answered 2 questions on the appropriateness and helpfulness of acupuncture being provided in the Emergency Department.
Individuals with direct exposure to ACUITY answered 2 more questions on satisfaction and burden of conducting ACUITY in their ED.
Recruitment period: May 3, 2021 - September 24, 2022 from three Emergency Departments
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management. |
| FG001 | Usual Care | This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management. |
| FG002 | ED Staff/Providers | These were ED staff or providers who answered questions after their site had finished study recruitment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants in the RCT (Overall Study) |
|
| |||||||||||||||||||||||||||
| ED Staff/Providers 6 Month Assessment |
|
Demographics and initial conditions of participants providing pre and post pain scores in part of the RCT.
Or the demographics of the ED Staff/Providers who answered several questions at the 6 month point after recruitment in their ED was complete.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management. |
| 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 | Successful Recruitment of Participants Into the Study. | The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site. | Patients who were eligible AND approached. | Posted | Number | Percentage of participants enrolled | At Enrollment |
|
Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm
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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 | Acupuncture | This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Non-systematic Assessment | Death due to retroperitoneal hemorrhage (preliminary cause of death) and cirrhosis (secondary) at Site 2 about 7 days after their ED discharge and subsequent inpatient admission . It was unanticipated, fatal and not study related |
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It should be noted that recruitment was conducted during the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Dusek | University California-Irvine | 617-519-8082 | jdusek@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 9, 2022 | Dec 14, 2022 | Prot_SAP_ICF_003.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D004630 | Emergencies |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D059408 | Pain Management |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
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| OTHER |
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Data collector will be masked to study outcomes via electronic data collection
| Usual care for pain management | Other | Patient will receive usual care for pain management. |
|
| Percentage of Patients Retained at 1-week Follow up |
Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. |
| One-week after the participant was discharged from the ED |
| Patient Satisfaction Question 1 at Post-treatment | Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | At post-treatment (45-60 minutes after baseline) |
| Patient Satisfaction Question 2 at Post-treatment | "Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | At post-treatment (45-60 minutes after baseline) |
| Patient Satisfaction Question 1 at 1-Week | "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | One week after participant was discharged from the ED |
| Patient Satisfaction Question 2 at 1 Week | "Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | One week after participant was discharged from the ED |
| Provider Satisfaction Question1 | "Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better. | After enrollment at the provider's site completed (~6 months after first enrollee). |
| Provider Satisfaction Question 2 | "Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better. | After enrollment at the provider's site completed (~6 months after first enrollee). |
| Provider Satisfaction Question 3 | "How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better | After enrollment at the provider's site completed (~6 months after first enrollee). |
| Provider Satisfaction Que4 | "Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better | After enrollment at the provider's site completed (~6 months after first enrollee). |
| The Bronx |
| New York |
| 10461 |
| United States |
| University Hospitals/Case Western Reserve University- Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Vandebilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| 35244059 | Derived | Dusek JA, Kallenberg GA, Hughes RM, Storrow AB, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, McKee MD. Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study. Medicine (Baltimore). 2022 Mar 4;101(9):e28961. doi: 10.1097/MD.0000000000028961. |
| 35229658 | Derived | Nielsen A, Olson J, Quesada M, Zhu C, Raskin E, Vang B, Painovich J, Scott M, Xiong VJ, Dusek JA. Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1. |
| 34009391 | Derived | Dyer NL, Surdam J, Dusek JA. A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action. Pain Med. 2022 Jan 3;23(1):189-210. doi: 10.1093/pm/pnab151. |
| Delay due to ED imaging |
|
| Early discharge |
|
| Completed Question 2 |
|
| Completed Question 3 |
|
| Completed Question 4 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Usual Care | This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management. |
| BG002 | ED Staff/Providers | ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED. If the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data not collected for the ED Staff/Providers Arm | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm | Number | individuals |
|
| Education | Education data not collected for the ED Staff/Providers Arm | Count of Participants | Participants |
|
| Income | Income data not collected for the ED Staff/Providers Arm | Count of Participants | Participants |
|
| Insurance | Insurance data not collected for the ED Staff/Providers Arm | Count of Participants | Participants |
|
| Location of Pain | Location of Pain data not collected for the ED Staff/Providers Arm | Count of Participants | Participants |
|
| Prior Acupuncture | Prior Acupuncture data not collected for the ED Staff/Providers Arm | Count of Participants | Participants |
|
| Pain Intensity | 0-10 Numeric Rating Scale of Pain Intensity (where "0" is No pain and "10" is maximal Pain) | Pain Intensity data not collected for the ED Staff/Providers Arm | Mean | Standard Deviation | units on a scale |
|
| Anxiety- acute | 0-10 Numeric Rating Scale of acute anxiety (where "0" is No anxiety and "10" is maximal anxiety) | Anxiety- acute data not collected for the ED Staff/Providers Arm | Mean | Standard Deviation | units on a scale |
|
| VUMC |
Patients approached at VUMC |
| OG003 | UCSD | Patients approached at UCSD |
|
|
| Secondary | Percentage of Participants Retained in the Study at Post Treatment | Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. | Participants who enrolled | Posted | Number | percentage of patients retained at post | At post treatment (45-60 minutes) |
|
|
|
| Secondary | Percentage of Patients Retained at 1-week Follow up | Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. | Participants who enrolled | Posted | Number | percentage of patients retained at 1-wk | One-week after the participant was discharged from the ED |
|
|
|
| Secondary | Patient Satisfaction Question 1 at Post-treatment | Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | Participants who has Post-treatment scores and answered satisfaction question 1 at post-treatment | Posted | Mean | Standard Deviation | units on a scale | At post-treatment (45-60 minutes after baseline) |
|
|
|
| Secondary | Patient Satisfaction Question 2 at Post-treatment | "Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | Participants who has Post-treatment scores and answered satisfaction question 2 at post-treatment | Posted | Mean | Standard Deviation | units on a scale | At post-treatment (45-60 minutes after baseline) |
|
|
|
| Secondary | Patient Satisfaction Question 1 at 1-Week | "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | Participants who has Post-treatment scores and answered satisfaction question 1 at 1-week FU | Posted | Mean | Standard Deviation | units on a scale | One week after participant was discharged from the ED |
|
|
|
| Secondary | Patient Satisfaction Question 2 at 1 Week | "Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). | Participants who has Post-treatment scores and answered satisfaction question 2 at 1-week FU | Posted | Mean | Standard Deviation | units on a scale | One week after participant was discharged from the ED |
|
|
|
| Secondary | Provider Satisfaction Question1 | "Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better. | Providers who responded to the survey after their site completed enrollment. | Posted | Mean | Standard Deviation | score on a scale | After enrollment at the provider's site completed (~6 months after first enrollee). |
|
|
|
| Secondary | Provider Satisfaction Question 2 | "Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better. | Providers who responded to the survey. | Posted | Mean | Standard Deviation | score on a scale | After enrollment at the provider's site completed (~6 months after first enrollee). |
|
|
|
| Secondary | Provider Satisfaction Question 3 | "How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better | Providers who responded to the survey and were exposed to ACUITY | Posted | Mean | Standard Deviation | score on a scale | After enrollment at the provider's site completed (~6 months after first enrollee). |
|
|
|
| Secondary | Provider Satisfaction Que4 | "Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better | Providers who responded to the survey and were exposed to ACUITY | Posted | Mean | Standard Deviation | score on a scale | After enrollment at the provider's site completed (~6 months after first enrollee). |
|
|
|
| 1 |
| 83 |
| 1 |
| 83 |
| 0 |
| 83 |
| EG001 | Usual Care | This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management. | 0 | 82 | 1 | 82 | 0 | 82 |
| EG002 | ED Staff/Providers | ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED. If the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED. | 0 | 125 | 0 | 125 | 0 | 125 |
|
| Hospitalization for Suspected Stroke | Vascular disorders | Non-systematic Assessment | Hospitalization included diagnosis of new cerebral mass lesion concerning for metastasis and likely culprit of the patients symptoms. Patient also diagnosed with Left low extremity DVT. It was unexpected, severe and not study related |
|
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Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D006298 |
| Health Services Administration |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Some college |
|
| College degree |
|
| Graduate or professional degree |
|
| Decline to answer |
|
| $50,001 to $100,000 |
|
| $100,001 to $150,000 |
|
| More than $150,000 |
|
| Decline to answer |
|
| Private insurance |
|
| No insurance |
|
| Decline to answer |
|
| Flank |
|
| Chest |
|
| Back |
|
| Extremity |
|
| Neck |
|
| Multiple |
|
| Other |
|