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| Name | Class |
|---|---|
| Rx Foundation | OTHER |
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This study examines the implications of providing hospital-level care in rural homes.
Home hospital care is hospital-level care at home for acutely ill patients. In multiple publications mostly in urban environments, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models deliver care in urban environments, not in rural environments.
To further improve the model, the investigators propose to determine the feasibility of home hospital care in a rural home setting through a proof-of-concept approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home hospital care | Experimental | Patients receive hospital-level care in their home, as a substitute to traditional hospital care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home hospital care | Other | Patients receive hospital-level care in their home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Completed Their Rural Home Hospitalization | Rural home hospital is when eligible rural patients receive hospital level care at home. This measure includes patients that were hospitalized in rural home hospital for treatment for their acute condition and were discharged from rural home hospital after their treatment was complete. The number in the data table reflects the number of patients that completed their home hospitalization. | Day of admission to day of discharge, estimated 10 days later |
| Measure | Description | Time Frame |
|---|---|---|
| 3-item Care Transition Measure | This is a hospital level measure of performance that reports the average patient reported quality of preparation for self-care response among adult patients discharged from general acute care hospitals. Data will be collected by a Research Assistant via patient, ( scale of 1 to 12; where 12 indicates highest readiness to transition). The final score is calculated by calculating the sum or responses across the three items ((score Strongly Disagree = 1; Disagree = 2; Agree = 3; Strongly Agree = 4), the number of questions answers are counted, and then the mean response is then calculated (sum divided by count). |
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Patient clinical inclusion Criteria:
Patient social inclusion criteria:
Patient caregiver inclusion criteria: (not required for patient participation):
Clinician inclusion criteria:
-Any member of the rural home hospital (RHH) clinical team (MD, RN, paramedic, NP) who will be participating in the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.
Patient Clinical Exclusion Criteria:
Acute delirium, as determined by the Confusion Assessment Method
Cannot establish peripheral access (or access requires ultrasound guidance, unless ultrasound guidance is available)
Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
Primary diagnosis requires controlled substances
Cannot independently ambulate to bedside commode
As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
For pneumonia: Most recent CURB65 > 3: new confusion, BUN > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65 (<14% 30-day mortality); Most recent SMRTCO > 2: systolic blood pressure < 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90% (<10% chance of intensive respiratory or vasopressor support); Absence of clear infiltrate on imaging; Cavitary lesion on imaging; Pulmonary effusion of unknown etiology; O2 saturation < 90% despite 5L O2
For heart failure: Has a left ventricular assist device; GWTG-HF17 (>10% in-hospital mortality) or ADHERE18 (high risk or intermediate risk 1)*; Severe pulmonary hypertension
For complicated urinary tract infection: Absence of pyuria; Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)
For other infection: Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)
For COPD: BAP-65 score > 3 (BUN>25, altered mental status, HR>109, age>65) (<13% chance in-hospital mortality): exercise caution
For asthma: Peak expiratory flow < 50% of normal: exercise caution
For diabetes and its complications: Requires IV insulin
For hypertensive urgency: Systolic blood pressure > 190 mmHg; Evidence of end-organ damage; for example, acute kidney injury, focal neurologic deficits, myocardial infarction
For atrial fibrillation with rapid ventricular response: Likely to require cardioversion; New atrial fibrillation with rapid ventricular response; Unstable blood pressure, respiratory rate, or oxygenation; Despite IV beta and/or calcium channel blockade in the emergency department, HR remains > 125 and SBP remains different than baseline; Less than 1 hour of time has elapsed with HR < 125 and SBP similar or higher than baseline
For patients with end-stage renal disease on peritoneal dialysis: Peritoneal catheter malfunction; Requires temporary hemodialysis
Home hospital census is full (maximum 3 patients at any time)
Patient social exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23608775 | Background | Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478. | |
| 19347026 | Background | Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24. |
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No significant event occurred after participant enrollment
A patient may be considered for Rural home hospital care if they are acutely ill at home, present acutely ill to a clinic or emergency department, or if they are admitted and require additional days of acute care. They must meet inclusion and exclusion criteria and be assessed for eligibility by the rural home hospital physician. Clinicians are any member of the rural home hospital clinical team that will be providing care to rural patients that enroll in the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients | Patients who received the home hospital intervention. Patients receive hospital-level care in their home, as a substitute to traditional hospital care. |
| FG001 | Clinicians | Clinicians that provide hospital-level care in a patient's home, as a substitute to traditional hospital care. Home hospital care: Patients receive hospital-level care in their home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population only includes patients. Baseline characteristics were not collected for clinicians
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients | Patients receive hospital-level care in their home, as a substitute to traditional hospital care. Home hospital care: Patients receive hospital-level care in their home. |
| BG001 | Clinicians |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients That Completed Their Rural Home Hospitalization | Rural home hospital is when eligible rural patients receive hospital level care at home. This measure includes patients that were hospitalized in rural home hospital for treatment for their acute condition and were discharged from rural home hospital after their treatment was complete. The number in the data table reflects the number of patients that completed their home hospitalization. | Three patients completed a rural home hospitalization. Rural home hospitalized patients were treated for their acute condition in rural home hospital. | Posted | Count of Participants | Participants | Day of admission to day of discharge, estimated 10 days later |
|
Adverse events were collected from the start of the study through study completion. This was a period of three months in total.
No serious adverse events were reported and there was no risk for all-cause mortality.
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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 | Patients | Patients who received the home hospital intervention. Patients receive hospital-level care in their home, as a substitute to traditional hospital care. Adverse events were monitored only for patients. |
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Our study has limitations.1. We admitted three patients from two rural areas of Utah, limiting generalizability. Second, two out of three patients were lost to follow-up and did not complete a discharge survey or interview. These patients may have had experiences we did not capture.Third, given this was a small proof of concept, the technology systems were not integrated by design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Levine | Brigham and Women's Hospital | 6177328925 | dmlevine@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 | Jan 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D051436 | Renal Insufficiency, Chronic |
| D000096003 | Hypertensive Crisis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D018575 | Home Care Services, Hospital-Based |
| ID | Term |
|---|---|
| D006699 | Home Care Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Once, within Day of discharge to 7 days later |
| Picker Experience Questionnaire | The Picker Patient Experience Questionnaire is a fifteen item questionnaire covering eight domains including information & education and coordination of care. The questionnaire is used to measure patient experience with in-patient care. The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). A problem is defined as any aspect of health care that could be improved upon. Data will be collected by a research assistant via patient. Scale of 1-15, where a higher score indicates better patient experience. | Once, within Day of discharge to 7 days later |
| Global Satisfaction: Scale | Measure of patient experience and satisfaction with care using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible. Data will be collected by a Research Assistant via patient | Once, between Day of discharge to 7 days later |
| Perceived Acceptability of RHH Care | Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.The numbers in the data table reflect the number of patients and clinicians that perceived rural home hospital care to be acceptable. | Day of discharge to 30 days later |
| Perceived Safety, Quality of Care, Caregiver Burden | Perceived safety, quality of care, caregiver burden will be assessed qualitatively through one post-discharge semi-structured interview with each participating clinician, patient, and caregiver. The numbers in the data table reflect the number of patients and clinicians that perceived that rural home hospital was safe and that the care provided was of high quality. | Day of discharge to 30 days later |
| Number of Rural Home Hospital Patients Escalated to Hospital for Care | If enrolled patient must be discharged from rural home hospital and taken to an acute-care hospital for care. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic | Day of admission to day of discharge, estimated 10 days later |
| Number of Patients With an Adverse Event | Adverse events include Fall, Delirium, Potentially preventable Venous Thromboembolism (VTE), New pressure ulcer, Thrombophlebitis at peripheral intravenous line (IV) site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic | Day of admission to day of discharge, estimated 10 days later |
| Number of Patients With Unplanned Mortality During Admission | Any case of unplanned death among enrolled rural home hospital patient.Data to be collected daily by a research assistant via the Registered Nurse or Paramedic | Day of admission to day of discharge, estimated 10 days later |
| Lab Orders, Number | Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records | Day of admission to day of discharge, estimated 10 days later |
| Length of Stay | The number of days enrolled patient is admitted to rural home hospital.Data to be collected daily by a research assistant via rural home hospital records. | Day of admission to day of discharge, estimated 10 days later |
| Unplanned Readmission(s), Number or Patients | Unplanned readmission of patient to hospital 30 days post discharge from rural home hospital. Data to be collected by a research assistant via the patient. | 30-days post-discharge |
| ED Visit(s), Number | Any Emergency Department (ED) visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient | 30-days post-discharge |
| Background | 2014 National and State Healthcare-Associated Infections Progress Report.; 2016. http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016. |
| 11129745 | Background | Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x. |
| 16330791 | Background | Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008. |
| 22665835 | Background | Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132. |
| 29411238 | Background | Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6. |
| Background | Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-america.html. Published 2017. Accessed May 31, 2019. |
| 31697657 | Background | Garcia MC, Rossen LM, Bastian B, Faul M, Dowling NF, Thomas CC, Schieb L, Hong Y, Yoon PW, Iademarco MF. Potentially Excess Deaths from the Five Leading Causes of Death in Metropolitan and Nonmetropolitan Counties - United States, 2010-2017. MMWR Surveill Summ. 2019 Nov 8;68(10):1-11. doi: 10.15585/mmwr.ss6810a1. |
| Background | Parker K, Horowitz J, Brown A, Fry R, Cohn D, Igielnik R. What Unites and Divides Urban, Suburban and Rural Communities.; 2018. https://www.pewsocialtrends.org/wpcontent/uploads/sites/3/2018/05/Pew-Research-Center-Community-Type-Full-Report-FINAL.pdf. Accessed May 31, 2019 |
| 8417639 | Background | Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011. |
| 23549583 | Background | Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013 Apr 3;309(13):1379-87. doi: 10.1001/jama.2013.2366. |
| 21730240 | Background | Joynt KE, Harris Y, Orav EJ, Jha AK. Quality of care and patient outcomes in critical access rural hospitals. JAMA. 2011 Jul 6;306(1):45-52. doi: 10.1001/jama.2011.902. |
Clinicians that provide hospital-level care in a patient's home, as a substitute to traditional hospital care.
Home hospital care: Patients receive hospital-level care in their home.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 3-item Care Transition Measure | This is a hospital level measure of performance that reports the average patient reported quality of preparation for self-care response among adult patients discharged from general acute care hospitals. Data will be collected by a Research Assistant via patient, ( scale of 1 to 12; where 12 indicates highest readiness to transition). The final score is calculated by calculating the sum or responses across the three items ((score Strongly Disagree = 1; Disagree = 2; Agree = 3; Strongly Agree = 4), the number of questions answers are counted, and then the mean response is then calculated (sum divided by count). | Rural home hospitalized patients that completed the discharge survey | Posted | Mean | Standard Deviation | score on a scale | Once, within Day of discharge to 7 days later |
|
|
|
| Secondary | Picker Experience Questionnaire | The Picker Patient Experience Questionnaire is a fifteen item questionnaire covering eight domains including information & education and coordination of care. The questionnaire is used to measure patient experience with in-patient care. The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). A problem is defined as any aspect of health care that could be improved upon. Data will be collected by a research assistant via patient. Scale of 1-15, where a higher score indicates better patient experience. | Rural home hospitalized patients that completed the discharge survey | Posted | Mean | Standard Deviation | score on a scale | Once, within Day of discharge to 7 days later |
|
|
|
| Secondary | Global Satisfaction: Scale | Measure of patient experience and satisfaction with care using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible. Data will be collected by a Research Assistant via patient | Rural home hospitalized patients that completed the discharge survey | Posted | Mean | Standard Deviation | score on a scale | Once, between Day of discharge to 7 days later |
|
|
|
| Secondary | Perceived Acceptability of RHH Care | Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.The numbers in the data table reflect the number of patients and clinicians that perceived rural home hospital care to be acceptable. | Only one patient that completed home hospital hospitalization completed a qualitative interview post discharge therefore qualitative data was collected from only one patient. Four clinicians completed qualitative interviews and therefore qualitative data from four clinicians was analyzed. | Posted | Count of Participants | Participants | Day of discharge to 30 days later |
|
|
|
| Secondary | Perceived Safety, Quality of Care, Caregiver Burden | Perceived safety, quality of care, caregiver burden will be assessed qualitatively through one post-discharge semi-structured interview with each participating clinician, patient, and caregiver. The numbers in the data table reflect the number of patients and clinicians that perceived that rural home hospital was safe and that the care provided was of high quality. | One patient that completed home hospital hospitalization completed a qualitative interview post discharge therefore qualitative data was collected from only one patient. Four clinicians completed qualitative interviews | Posted | Count of Participants | Participants | Day of discharge to 30 days later |
|
|
|
| Secondary | Number of Rural Home Hospital Patients Escalated to Hospital for Care | If enrolled patient must be discharged from rural home hospital and taken to an acute-care hospital for care. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic | Three patients were enrolled in this study, these patients received the home hospital intervention. Patients receive hospital-level care in their home, as a substitute to traditional hospital care. | Posted | Count of Participants | Participants | Day of admission to day of discharge, estimated 10 days later |
|
|
|
| Secondary | Number of Patients With an Adverse Event | Adverse events include Fall, Delirium, Potentially preventable Venous Thromboembolism (VTE), New pressure ulcer, Thrombophlebitis at peripheral intravenous line (IV) site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic | Posted | Count of Participants | Participants | Day of admission to day of discharge, estimated 10 days later |
|
|
|
| Secondary | Number of Patients With Unplanned Mortality During Admission | Any case of unplanned death among enrolled rural home hospital patient.Data to be collected daily by a research assistant via the Registered Nurse or Paramedic | Posted | Count of Participants | Participants | Day of admission to day of discharge, estimated 10 days later |
|
|
|
| Secondary | Lab Orders, Number | Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records | Patients that were home hospitalized | Posted | Number | lab orders | Day of admission to day of discharge, estimated 10 days later |
|
|
|
| Secondary | Length of Stay | The number of days enrolled patient is admitted to rural home hospital.Data to be collected daily by a research assistant via rural home hospital records. | Patients that were home hospitalized | Posted | Mean | Standard Deviation | number of days | Day of admission to day of discharge, estimated 10 days later |
|
|
|
| Secondary | Unplanned Readmission(s), Number or Patients | Unplanned readmission of patient to hospital 30 days post discharge from rural home hospital. Data to be collected by a research assistant via the patient. | Posted | Count of Participants | Participants | 30-days post-discharge |
|
|
|
| Secondary | ED Visit(s), Number | Any Emergency Department (ED) visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient | Patients that were home hospitalized | Posted | Number | number of ED visits | 30-days post-discharge |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Clinicians | Adverse events were not monitored for clinicians. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |