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Service Dogs are trained to assist people with disabilities to accomplish tasks which permit the individual to be more functional in their home and social environment. Often the dogs are trained to help in the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.
Background: Service Dogs are trained to assist people with disabilities to accomplish tasks which permit the individual to be more functional in their home and social environment. Often the dogs are trained to help in the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.
Study Primary Objective: To examine how limitations on activity and quality of life in Veterans with PTSD are impacted by the provision of a Service Dog versus an Emotional Support Dog.
Study Design: A prospective randomized study is proposed which has two randomized arms. Arm one of the study will be Veterans (n=110) randomized and paired with a Service Dog, which has been trained in 5 PTSD-specific tasks to assist with the Veteran's PTSD issues. Arm two (n=110) of the study will be Veterans randomized and paired with an Emotional Support Dog (a dog that provides support via emotional comfort). All Veterans, after confirmation of eligibility, will be randomized to receive a Service Dog or Emotional Support Dog and will be observed for a minimum of three months prior to receiving their dog. During this observation period, Veterans will be required to participate in a Dog Care Course to ensure they are aware of the demands dogs place on humans. Once a dog becomes available, the Veteran will be paired with a Service Dog or Emotional Support Dog. Pairing is the training process in which the Veteran is given instruction and practice in commanding and caring for their new service dog or emotional support dog. The pairing process for a service dog takes place at the contracted dog vendor's location; the pairing process for an emotional support dog takes place at the Veteran's home, facilitated by a VA Dog Trainer. Follow-up with the Veteran begins one week post pairing to track any dog behavior issues, and will continue after pairing for 18 months. Primary outcomes to be examined include limitations on Veteran activity (as measured by the WHO-DAS 2.0) and quality of life (measured by the VR-12). Secondary outcomes include PTSD symptoms (measured by the PCL-5), suicidal ideation (C-SSRS); depression (PHQ-9) and Sleep (PSQI). In addition, health care utilization, anger management (DAR), employment, and work productivity will also be examined. Study outcomes are assessed at baseline (prior to randomization), and at 3-month intervals after a Veteran is paired with a dog until 18 months post pairing. This multi-site study will be conducted at three locations nationwide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotional Support Dogs | Active Comparator | Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized. |
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| Service Dogs | Active Comparator | Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional Support Dogs | Other | Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized. |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012). | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Global Score | The Pittsburgh Sleep Quality Index (PSQI) is a self-administered survey used to assess sleep-related problems during the past month (Buysse, et al., 1989). The 19 items completed by the participant are grouped into seven components: (1) Sleep quality, (2) Sleep latency, (3) Sleep duration, (4) Habitual sleep efficiency, (5) Sleep disturbances, (6) Use of sleep medication, and (7) Daytime dysfunction. Each of the seven components are weighted equally on a 0-3 scale with 0 (better) to 3 (worse). These are summed to yield a global score with a range of 0-21 with higher scores indicating worse sleep quality. |
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Inclusion Criteria:
Males and Females greater than> 18 years of age.
Referral from Mental Health provider that documents PTSD.
PTSD as a result of any trauma as determined by meeting DSM 5 diagnostic criteria.
Enrolled in mental health services at VA and has attended at least one visit in the 90 days prior to consent.
Agrees to remain in mental health treatment throughout the duration of the study
Can adequately care for a dog .
Home environment is suitable for a dog.
Home environment is structurally and geographically accessible to study staff.
Is willing to accept randomization outcome.
Has someone to care for dog during extended absence of the participant.
Others in home are agreeable to having dog.
Is willing and able to travel (by air or car) to training site for pairing.
Individual has no household pets that would threaten the bonding and obedience training of an assigned study dog.
Individual can verbalize understanding of consent form, is willing to provide written informed consent and to follow study procedures.
Exclusion Criteria:
Hospitalization for mental health reasons in the past 6 months.
Aggressive behavior that would make it unsafe for dog.
Diagnosis of psychosis, delusions, dementia, moderate or severe alcohol/substance disorder (SUD), or moderate to severe traumatic brain injury as determined by the presence or absence of a condition following scoring of MINI responses or as documented in chart notes.
SUD assessment (alcohol/non-alcohol):
Active suicidal intent as determined by a CPRS flag for suicidal intent or an endorsement of yes to question 5 (active suicidal ideation with specific plan and intent) on the C-SSRS completed at the Clinic Qualifying Visit.
Homicidal intent or cognitive disabilities that would preclude safety of dog and/or ability to participate in the study.
Social, mental or physical condition that prevents the potential participant from either giving informed consent or participating in the study.
Participation in another unapproved research trial.
Has chart note flag for violent/disruptive behavior.
Potential participants who are pregnant/who have a partner who is pregnant, or who currently have one or more children younger than age 5 in the household for more than 8 hours per day, one day a week will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Joan Richerson, DVM | Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | United States | ||
| Iowa City VA Health Care System, Iowa City, IA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28844986 | Result | Saunders GH, Biswas K, Serpi T, McGovern S, Groer S, Stock EM, Magruder KM, Storzbach D, Skelton K, Abrams T, McCranie M, Richerson J, Dorn PA, Huang GD, Fallon MT. Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD). Contemp Clin Trials. 2017 Nov;62:105-113. doi: 10.1016/j.cct.2017.08.017. Epub 2017 Aug 26. |
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Sixty participants of 287 consented participants were found to be ineligible for study randomization per study inclusion/exclusion criteria, resulting in 227 participants randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Emotional Support Dog | Participants with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized. |
| FG001 | Service Dogs | Participants with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Randomization and Observation Period |
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| Pairing With a Study Dog |
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Randomized participants paired with a study dog.
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| ID | Title | Description |
|---|---|---|
| BG000 | Emotional Support Dog | Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized. |
| BG001 | Service Dogs |
| 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, 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 | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012). | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days).
For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
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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 | Emotional Support Dog | Participants randomized and paired to receive an Emotional Support Dog Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 20 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy to animal | Immune system disorders | MedDRA 20 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Richerson | Tennesse Valley HCS | 615-574-8198 | joan.richerson@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2018 | Apr 14, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2019 | Apr 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Service Dogs | Other | Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind). |
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| Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | The Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5) symptoms of PTSD. Each symptom is scored on a scale of 0 (not at all) through 4 (extreme). A total symptom severity score is calculated by summing the scores for each of the 20 items. Scores can range from 0 to 80 with higher scores representing greater PTSD symptom severity. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Patient Health Questionnaire (PHQ-9) Score | The Patient Health Questionnaire (PHQ-9) assesses the severity of depression (Kroenke, et al., 2002). It consists of 9 depression symptom questions with response choices of 0 (not at all), 1 (several days), 2 (more than half of days), or 3 (nearly every day). The total score is calculated by adding together the symptom ratings for each of the 9 questions so that scores range from 0 to 27 (higher scores represent greater depression severity). | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Dimensions of Anger Reactions (DAR) Score | The 7-item Dimensions of Anger Reactions (DAR) is a seven-item scale that assesses anger disposition directed to others (Forbes, et al.,2004). For each item, participants indicate the degree to which each statement describes their feelings and behavior on an 8-point scale ranging from 0 (not at all) to 8 (exactly so). Scores are totaled yielding a range of 0 to 56 with higher scores indicating greater anger disposition. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | The Suicidal Behavior or Ideation (SBI) indicator derived from the Columbia Suicide Severity Rating Scale (C-SSRS) is dichotomized as the presence or absence of suicidal behavior or ideation. Presence of SBI is indicated by a "Yes" response to any one of the five suicidal behavior or the five suicidal ideation questions. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Percentage of Participants With a Non-VA Hospitalization | Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Utilization of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | 540 days starting on the pairing date; summarized into six 90-day periods |
| Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Utilization of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | 540 days starting on the pairing date; summarized into six 90-day periods |
| Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Cost of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | 540 days starting on the pairing date; summarized into six 90-day periods |
| Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Cost of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | 540 days starting on the pairing date; summarized into six 90-day periods |
| Total Cost of VA Healthcare (Inpatient and Outpatient) | Cost of VA inpatient and outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | 540 days starting on the pairing date; summarized into six 90-day periods |
| Percentage of Days Covered for Antidepressants | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antidepressants are reported for this outcome (as a percentage). | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
| Percentage of Days Covered for Antipsychotics | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antipsychotics are reported for this outcome (as a percentage). | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
| Percentage of Days Covered for Benzodiazepines | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for benzodiazepines are reported for this outcome (as a percentage). | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
| Percentage of Days Covered for Other Sedatives | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for other sedatives are reported for this outcome (as a percentage). | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
| Number of Veterans Employed | Employment assessed using the question "Are you currently employed (working for pay)?" from the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Sample size (n) reflects the number of participants who provided work productivity and employment information at the time of data collection. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Impact of Health on Work Productivity Score | Impact of Health on Work Productivity was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Only participants who were employed were included in this analysis. Scores can range from 0 (no impact of health on work productivity) to 10 (extreme impact of health on work productivity), so a higher score represents a greater impact of health on work productivity. | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
| Iowa City |
| Iowa |
| 52246-2208 |
| United States |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Nashville | Tennessee | 37212-2637 | United States |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Other reasons not paired with a study dog |
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| NOT COMPLETED |
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Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) | The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012). | The number analyzed is different from the analysis population due to one participant missing an assessment. | Mean | Standard Deviation | units on a scale |
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| Veterans Rand 12-Item Health Survey - Physical Component Score (VR-12 PCS) | The Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life and includes a physical component score (PCS) assessing general health, physical functioning, role limitations, and bodily pain (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. | The number analyzed is different from the analysis population due to one participant missing an assessment at baseline. | Mean | Standard Deviation | T-score |
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| Veterans Rand 12-Item Health Survey - Mental Component Score (VR-12 MCS) | The Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life and includes a mental component score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. | The number analyzed is different from the analysis population due to one participant missing an assessment at baseline. | Mean | Standard Deviation | T-score |
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| Title |
|---|
| Description |
|---|
| OG000 | Emotional Support Dogs | Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized. |
| OG001 | Service Dogs | Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind). |
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| Primary | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | T-score | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Primary | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | T-score | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Pittsburgh Sleep Quality Index (PSQI) Global Score | The Pittsburgh Sleep Quality Index (PSQI) is a self-administered survey used to assess sleep-related problems during the past month (Buysse, et al., 1989). The 19 items completed by the participant are grouped into seven components: (1) Sleep quality, (2) Sleep latency, (3) Sleep duration, (4) Habitual sleep efficiency, (5) Sleep disturbances, (6) Use of sleep medication, and (7) Daytime dysfunction. Each of the seven components are weighted equally on a 0-3 scale with 0 (better) to 3 (worse). These are summed to yield a global score with a range of 0-21 with higher scores indicating worse sleep quality. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | The Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5) symptoms of PTSD. Each symptom is scored on a scale of 0 (not at all) through 4 (extreme). A total symptom severity score is calculated by summing the scores for each of the 20 items. Scores can range from 0 to 80 with higher scores representing greater PTSD symptom severity. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Patient Health Questionnaire (PHQ-9) Score | The Patient Health Questionnaire (PHQ-9) assesses the severity of depression (Kroenke, et al., 2002). It consists of 9 depression symptom questions with response choices of 0 (not at all), 1 (several days), 2 (more than half of days), or 3 (nearly every day). The total score is calculated by adding together the symptom ratings for each of the 9 questions so that scores range from 0 to 27 (higher scores represent greater depression severity). | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Dimensions of Anger Reactions (DAR) Score | The 7-item Dimensions of Anger Reactions (DAR) is a seven-item scale that assesses anger disposition directed to others (Forbes, et al.,2004). For each item, participants indicate the degree to which each statement describes their feelings and behavior on an 8-point scale ranging from 0 (not at all) to 8 (exactly so). Scores are totaled yielding a range of 0 to 56 with higher scores indicating greater anger disposition. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | The Suicidal Behavior or Ideation (SBI) indicator derived from the Columbia Suicide Severity Rating Scale (C-SSRS) is dichotomized as the presence or absence of suicidal behavior or ideation. Presence of SBI is indicated by a "Yes" response to any one of the five suicidal behavior or the five suicidal ideation questions. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Count of Participants | Participants | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | number of visits | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | number of visits | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Percentage of Participants With a Non-VA Hospitalization | Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. | Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period. | Posted | Mean | Standard Deviation | Percentage of participants | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Utilization of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | Participants randomized and paired with an emotional support dog or a service dog. | Posted | Mean | Standard Deviation | number of visits | 540 days starting on the pairing date; summarized into six 90-day periods |
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| Secondary | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Utilization of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | Participants randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | Number of inpatient admissions | 540 days starting on the pairing date; summarized into six 90-day periods |
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| Secondary | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Cost of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | Participants randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | U.S. dollars | 540 days starting on the pairing date; summarized into six 90-day periods |
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| Secondary | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Cost of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | Participants randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | U.S. dollars | 540 days starting on the pairing date; summarized into six 90-day periods |
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| Secondary | Total Cost of VA Healthcare (Inpatient and Outpatient) | Cost of VA inpatient and outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. | Participants randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | U.S. dollars | 540 days starting on the pairing date; summarized into six 90-day periods |
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| Secondary | Percentage of Days Covered for Antidepressants | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antidepressants are reported for this outcome (as a percentage). | Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | Percentage of days | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
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| Secondary | Percentage of Days Covered for Antipsychotics | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antipsychotics are reported for this outcome (as a percentage). | Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | Percentage of days | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
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| Secondary | Percentage of Days Covered for Benzodiazepines | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for benzodiazepines are reported for this outcome (as a percentage). | Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | Percentage of days | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
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| Secondary | Percentage of Days Covered for Other Sedatives | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for other sedatives are reported for this outcome (as a percentage). | Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | Percentage of days | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 |
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| Secondary | Number of Veterans Employed | Employment assessed using the question "Are you currently employed (working for pay)?" from the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Sample size (n) reflects the number of participants who provided work productivity and employment information at the time of data collection. | Participants randomized and paired with an emotional support dog or a service dog | Posted | Count of Participants | Participants | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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| Secondary | Impact of Health on Work Productivity Score | Impact of Health on Work Productivity was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Only participants who were employed were included in this analysis. Scores can range from 0 (no impact of health on work productivity) to 10 (extreme impact of health on work productivity), so a higher score represents a greater impact of health on work productivity. | Participants randomized and paired with an emotional support dog or a service dog | Posted | Mean | Standard Deviation | score on a scale | Baseline and every 3 months after dog pairing up to 18 months post-pairing |
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|
| 1 |
| 84 |
| 21 |
| 84 |
| 5 |
| 84 |
| EG001 | Service Dog | Participants randomized and paired to receive a Service Dog Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges. | 0 | 97 | 18 | 97 | 0 | 97 |
| EG002 | Prior to Dog Pairing | All participants consented regardless of whether eventually randomized and paired with a dog. | 1 | 287 | 18 | 287 | 1 | 287 |
| Angina unstable | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Prinzmetal angina | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 20 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 20 | Systematic Assessment |
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| Gastritis alcoholic | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 20 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 20 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 20 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 20 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Infected skin ulcer | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
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| Heart rate decreased | Investigations | MedDRA 20 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
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| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 20 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 20 | Systematic Assessment |
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| Cervical radiculopathy | Nervous system disorders | MedDRA 20 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 20 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 20 | Systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Drug use disorder | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Substance use disorder | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
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| Social stay hospitalisation | Social circumstances | MedDRA 20 | Systematic Assessment |
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| Alcohol detoxification | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Heart valve replacement | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Liposuction | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Metabolic surgery | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Plastic surgery | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Rehabilitation therapy | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Spinal decompression | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Spinal operation | Surgical and medical procedures | MedDRA 20 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20 | Systematic Assessment |
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| Infestation | Infections and infestations | MedDRA 20 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 20 | Systematic Assessment |
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| Emotional distress | Psychiatric disorders | MedDRA 20 | Systematic Assessment |
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Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| 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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| Days 91-180 |
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| Days 181-270 |
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| Days 271-360 |
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| Days 361-450 |
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| Days 451-540 |
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| Days 91-180 |
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| Days 181-270 |
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| Days 271-360 |
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| Days 361-450 |
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| Days 451-540 |
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| Days 91-180 |
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| Days 361-450 |
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| Days 451-540 |
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| Days 91-180 |
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| Days 181-270 |
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| Days 271-360 |
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| Days 361-450 |
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| Days (451-540) |
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| Days 91-180 |
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| Days 181-270 |
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| Days 271-360 |
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| Days 361-450 |
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| Days 451-540 |
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