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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-1406-18876 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.
Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide.
Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery.
No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia, making the anesthetic care episode a major opportunity to impact outcomes.
Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice.
REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice.
Approximately 2,424 subjects will be enrolled (i.e. informed consent for participation will be obtained) in order to yield approximately 1,600 randomized patients. This estimate is based on an assumption that one in three patients (33%) who undergo consent prior to surgery will not be randomized on the day of surgery due to active clinical issues, timing of medication dosing, clinical assessments by treating physicians or the site Clinical Director or their designate, or patient withdrawal of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional Anesthesia | Active Comparator | Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. |
|
| General Anesthesia | Active Comparator | Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anesthesia | Procedure | Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required. |
| Measure | Description | Time Frame |
|---|---|---|
| Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | Will be assessed via telephone interview | Approximately 60 days after Randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Health and Disability | Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D Neuman, MD, MSc | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35249 | United States | ||
| University of California Davis Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37365614 | Derived | Clapp JT, Dinh C, Hsu M, Neuman MD. Clinical reasoning in pragmatic trial randomization: a qualitative interview study. Trials. 2023 Jun 27;24(1):431. doi: 10.1186/s13063-023-07445-3. | |
| 35696684 | Derived | Neuman MD, Feng R, Ellenberg SS, Sieber F, Sessler DI, Magaziner J, Elkassabany N, Schwenk ES, Dillane D, Marcantonio ER, Menio D, Ayad S, Hassan M, Stone T, Papp S, Donegan D, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes R, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Tierney A, Gaskins LJ, Horan AD, Brown T, Dattilo J, Carson JL; REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) Investigators*; Looke T, Bent S, Franco-Mora A, Hedrick P, Newbern M, Tadros R, Pealer K, Vlassakov K, Buckley C, Gavin L, Gorbatov S, Gosnell J, Steen T, Vafai A, Zeballos J, Hruslinski J, Cardenas L, Berry A, Getchell J, Quercetti N, Bajracharya G, Billow D, Bloomfield M, Cuko E, Elyaderani MK, Hampton R, Honar H, Khoshknabi D, Kim D, Krahe D, Lew MM, Maheshwer CB, Niazi A, Saha P, Salih A, de Swart RJ, Volio A, Bolkus K, DeAngelis M, Dodson G, Gerritsen J, McEniry B, Mitrev L, Kwofie MK, Belliveau A, Bonazza F, Lloyd V, Panek I, Dabiri J, Chavez C, Craig J, Davidson T, Dietrichs C, Fleetwood C, Foley M, Getto C, Hailes S, Hermes S, Hooper A, Koener G, Kohls K, Law L, Lipp A, Losey A, Nelson W, Nieto M, Rogers P, Rutman S, Scales G, Sebastian B, Stanciu T, Lobel G, Giampiccolo M, Herman D, Kaufman M, Murphy B, Pau C, Puzio T, Veselsky M, Apostle K, Boyer D, Fan BC, Lee S, Lemke M, Merchant R, Moola F, Payne K, Perey B, Viskontas D, Poler M, D'Antonio P, O'Neill G, Abdullah A, Fish-Fuhrmann J, Giska M, Fidkowski C, Guthrie ST, Hakeos W, Hayes L, Hoegler J, Nowak K, Beck J, Cuff J, Gaski G, Haaser S, Holzman M, Malekzadeh AS, Ramsey L, Schulman J, Schwartzbach C, Azefor T, Davani A, Jaberi M, Masear C, Haider SB, Chungu C, Ebrahimi A, Fikry K, Marcantonio A, Shelvan A, Sanders D, Clarke C, Lawendy A, Schwartz G, Garg M, Kim J, Caruci J, Commeh E, Cuevas R, Cuff G, Franco L, Furgiuele D, Giuca M, Allman M, Barzideh O, Cossaro J, D'Arduini A, Farhi A, Gould J, Kafel J, Patel A, Peller A, Reshef H, Safur M, Toscano F, Tedore T, Akerman M, Brumberger E, Clark S, Friedlander R, Jegarl A, Lane J, Lyden JP, Mehta N, Murrell MT, Painter N, Ricci W, Sbrollini K, Sharma R, Steel PAD, Steinkamp M, Weinberg R, Wellman DS, Nader A, Fitzgerald P, Ritz M, Bryson G, Craig A, Farhat C, Gammon B, Gofton W, Harris N, Lalonde K, Liew A, Meulenkamp B, Sonnenburg K, Wai E, Wilkin G, Troxell K, Alderfer ME, Brannen J, Cupitt C, Gerhart S, McLin R, Sheidy J, Yurick K, Chen F, Dragert K, Kiss G, Malveaux H, McCloskey D, Mellender S, Mungekar SS, Noveck H, Sagebien C, Biby L, McKelvy G, Richards A, Abola R, Ayala B, Halper D, Mavarez A, Rizwan S, Choi S, Awad I, Flynn B, Henry P, Jenkinson R, Kaustov L, Lappin E, McHardy P, Singh A, Donnelly J, Gonzalez M, Haydel C, Livelsberger J, Pazionis T, Slattery B, Vazquez-Trejo M, Baratta J, Cirullo M, Deiling B, Deschamps L, Glick M, Katz D, Krieg J, Lessin J, Mojica J, Torjman M, Jin R, Salpeter MJ, Powell M, Simmons J, Lawson P, Kukreja P, Graves S, Sturdivant A, Bryant A, Crump SJ, Verrier M, Green J, Menon M, Applegate R, Arias A, Pineiro N, Uppington J, Wolinsky P, Gunnett A, Hagen J, Harris S, Hollen K, Holloway B, Horodyski MB, Pogue T, Ramani R, Smith C, Woods A, Warrick M, Flynn K, Mongan P, Ranganath Y, Fernholz S, Ingersoll-Weng E, Marian A, Seering M, Sibenaller Z, Stout L, Wagner A, Walter A, Wong C, Orwig D, Goud M, Helker C, Mezenghie L, Montgomery B, Preston P, Schwartz JS, Weber R, Fleisher LA, Mehta S, Stephens-Shields AJ, Dinh C, Chelly JE, Goel S, Goncz W, Kawabe T, Khetarpal S, Monroe A, Shick V, Breidenstein M, Dominick T, Friend A, Mathews D, Lennertz R, Sanders R, Akere H, Balweg T, Bo A, Doro C, Goodspeed D, Lang G, Parker M, Rettammel A, Roth M, White M, Whiting P, Allen BFS, Baker T, Craven D, McEvoy M, Turnbo T, Kates S, Morgan M, Willoughby T, Weigel W, Auyong D, Fox E, Welsh T, Cusson B, Dobson S, Edwards C, Harris L, Henshaw D, Johnson K, McKinney G, Miller S, Reynolds J, Segal BS, Turner J, VanEenenaam D, Weller R, Lei J, Treggiari M, Akhtar S, Blessing M, Johnson C, Kampp M, Kunze K, O'Connor M, Looke T, Tadros R, Vlassakov K, Cardenas L, Bolkus K, Mitrev L, Kwofie MK, Dabiri J, Lobel G, Poler M, Giska M, Sanders D, Schwartz G, Giuca M, Tedore T, Nader A, Bryson G, Troxell K, Kiss G, Choi S, Powell M, Applegate R, Warrick M, Ranganath Y, Chelly JE, Lennertz R, Sanders R, Allen BFS, Kates S, Weigel W, Li J, Wijeysundera DN, Kheterpal S, Moore RH, Smith AK, Tosi LL, Looke T, Mehta S, Fleisher L, Hruslinski J, Ramsey L, Langlois C, Mezenghie L, Montgomery B, Oduwole S, Rose T; REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) Investigators. Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial. Ann Intern Med. 2022 Jul;175(7):952-960. doi: 10.7326/M22-0320. Epub 2022 Jun 14. |
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Of the 1848 participants who provided informed consent, 248 withdrew consent prior to randomization; 1600 participants were randomly assigned to a treatment group and continued in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regional Anesthesia | Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 29, 2016 | Apr 5, 2021 |
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|
|
| General Anesthesia | Procedure | General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required. |
|
|
| Approximately 60, 180, and 365 days after randomization |
| Ability to Return to Home | Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point. | Approximately 60, 180, and 365 days after randomization |
| Chronic Pain | Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain. | Approximately 60, 180, and 365 days after randomization |
| Cognitive Function | Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment. | Baseline and approximately 60, 180, and 365 days after randomization |
| All-cause Mortality | Will be assessed via telephone interview and National Death Index (NDI) search | Approximately 60, 180, and 365 days after randomization |
| Need for Assistive Devices for Walking | Will be assessed via telephone interview | Approximately 60, 180, and 365 days after randomization |
| Acute Postoperative Pain | Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain. | Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first |
| Satisfaction With Care | Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of "dissatisfied" or "very dissatisfied" to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general. | Postoperative day 3 or day of discharge, whichever occurs first |
| Postoperative Delirium | Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium. | Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first |
| Inpatient Mortality | Will be assessed via medical chart review. Data reported here on inpatient mortality. | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first |
| Major Inpatient Morbidity | Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury. | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first |
| Sacramento |
| California |
| 95817 |
| United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| Christiana Care Health Services | Newark | Delaware | 19718 | United States |
| University of Florida Gainesville | Gainesville | Florida | 32608 | United States |
| University of Florida Jacksonville | Jacksonville | Florida | 32209 | United States |
| Florida Hospital | Winter Park | Florida | 32792 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Iowa Hospital & Clinics | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Rutgers-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| NYU-Winthrop Hospital | Mineola | New York | 11501 | United States |
| NYU Langone Medical Center | New York | New York | 10003 | United States |
| New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Sacred Heart at RiverBend | Springfield | Oregon | 97477 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospitals | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Reading Hospital | Reading | Pennsylvania | 19611 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| University Medical Center Brackenridge and Seton Medical Center Williamson | Austin | Texas | 78705 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Inova Fairfax Medical Campus | Fairfax | Virginia | 22042 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
| Simon Fraser Orthopaedic Fund - Royal Columbian Hospital | New Westminster | British Columbia | V3L 3M2 | Canada |
| Dalhousie University | Halifax | Nova Scotia | B3H 1V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Toronto Western Hospital | Toronto | Ontario | Canada |
| 34623788 | Derived | Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9. |
| 28982261 | Derived | Neuman MD, Gaskins LJ, Ziolek T; REGAIN Investigators. Time to institutional review board approval with local versus central review in a multicenter pragmatic trial. Clin Trials. 2018 Feb;15(1):107-111. doi: 10.1177/1740774517735536. Epub 2017 Oct 6. |
| 27852723 | Derived | Neuman MD, Ellenberg SS, Sieber FE, Magaziner JS, Feng R, Carson JL; REGAIN Investigators. Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial. BMJ Open. 2016 Nov 15;6(11):e013473. doi: 10.1136/bmjopen-2016-013473. |
| FG001 | General Anesthesia | Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regional Anesthesia | Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required. |
| BG001 | General Anesthesia | Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Ethnicity was reported by patients or their proxies. Data missing for some participants. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 3D-CAM Assessment for Delirium | 3D-CAM Assessment positive for delirium prior to randomization | Only participants with completed baseline 3D-CAM assessments are included. | Count of Participants | 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 | Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | Will be assessed via telephone interview | Posted | Count of Participants | Participants | Approximately 60 days after Randomization |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Overall Health and Disability | Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability. | Patients providing data at each time point | Posted | Median | Inter-Quartile Range | score on a scale | Approximately 60, 180, and 365 days after randomization |
| ||||||||||||||||||||||||||||||
| Secondary | Ability to Return to Home | Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point. | This outcome was assessed among patients who were not admitted from a nursing home, rehabilitation facility, or acute care hospital. Denominator includes all known decedents at each time point, plus survivors providing information on location of residence at the time of study interview. | Posted | Count of Participants | Participants | Approximately 60, 180, and 365 days after randomization |
| |||||||||||||||||||||||||||||||
| Secondary | Chronic Pain | Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain. | Numbers differ across rows due to missing data | Posted | Mean | Standard Deviation | units on a scale | Approximately 60, 180, and 365 days after randomization |
| ||||||||||||||||||||||||||||||
| Secondary | Cognitive Function | Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment. | Numbers differ across rows due to missing data | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and approximately 60, 180, and 365 days after randomization |
| ||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality | Will be assessed via telephone interview and National Death Index (NDI) search | All enrolled patients who had not withdrawn or been lost to follow up a given study time point | Posted | Number | participants | Approximately 60, 180, and 365 days after randomization |
| |||||||||||||||||||||||||||||||
| Secondary | Need for Assistive Devices for Walking | Will be assessed via telephone interview | 60-day outcome | Posted | Count of Participants | Participants | Approximately 60, 180, and 365 days after randomization |
| |||||||||||||||||||||||||||||||
| Secondary | Acute Postoperative Pain | Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain. | Posted | Mean | Standard Deviation | units on a scale | Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first |
| |||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Care | Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of "dissatisfied" or "very dissatisfied" to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general. | Posted | Count of Participants | Participants | Postoperative day 3 or day of discharge, whichever occurs first |
| ||||||||||||||||||||||||||||||||
| Secondary | Postoperative Delirium | Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium. | This outcome was assessed only among patients who had a negative 3D-CAM assessment for delirium before randomization. | Posted | Count of Participants | Participants | Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first |
| |||||||||||||||||||||||||||||||
| Secondary | Inpatient Mortality | Will be assessed via medical chart review. Data reported here on inpatient mortality. | Posted | Count of Participants | Participants | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first |
| ||||||||||||||||||||||||||||||||
| Secondary | Major Inpatient Morbidity | Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury. | Posted | Count of Participants | Participants | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first |
|
Adverse data were collected for up to one year post-randomization.
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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 | Regional Anesthesia | Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required. | 98 | 795 | 255 | 795 | 278 | 795 |
| EG001 | General Anesthesia | Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required. | 92 | 805 | 242 | 805 | 286 | 805 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anemia associated with other specified nutritional deficiency | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukopenia NOS | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrioventricular block complete | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Non-systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular arrhythmia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Femoral anteversion | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Blurred vision | Eye disorders | Non-systematic Assessment |
| ||
| Keratitis | Eye disorders | Non-systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Esophageal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GI bleed | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GI hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hiatal hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatic necrosis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Retroperitoneal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Death NOS | General disorders | Non-systematic Assessment |
| ||
| Edema limbs | General disorders | Non-systematic Assessment |
| ||
| Facial pain | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Flu like symptoms | General disorders | Non-systematic Assessment |
| ||
| Gait disturbance | General disorders | Non-systematic Assessment |
| ||
| Multi-organ failure | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Weakness | General disorders | Non-systematic Assessment |
| ||
| Weakness generalized | General disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Gallbladder obstruction | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Ischemic hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Obstructive jaundice | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Acute diverticulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Bone infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cystitis bacterial | Infections and infestations | Non-systematic Assessment |
| ||
| Device related infection | Infections and infestations | Non-systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Incision site infection | Infections and infestations | Non-systematic Assessment |
| ||
| Infection NOS | Infections and infestations | Non-systematic Assessment |
| ||
| Joint infection | Infections and infestations | Non-systematic Assessment |
| ||
| Kidney infection | Infections and infestations | Non-systematic Assessment |
| ||
| Klebsiella pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia pseudomonal | Infections and infestations | Non-systematic Assessment |
| ||
| Post procedural pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Post procedural site wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Acute kidney injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Drug toxicity | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fat embolism | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fractured radial head | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Laceration of head | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural pulmonary embolism | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural stroke | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Biopsy of lymph node | Investigations | Non-systematic Assessment |
| ||
| Cardiac troponin I increased | Investigations | Non-systematic Assessment |
| ||
| Cardiac troponin T increased | Investigations | Non-systematic Assessment |
| ||
| Creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Crossmatch incompatible | Investigations | Non-systematic Assessment |
| ||
| Cystoscopy | Investigations | Non-systematic Assessment |
| ||
| Electrocardiogram T wave abnormal | Investigations | Non-systematic Assessment |
| ||
| INR increased | Investigations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Supratherapeutic INR | Investigations | Non-systematic Assessment |
| ||
| Troponin increased | Investigations | Non-systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Other severe protein-calorie malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Avascular necrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle contracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nonunion of fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Leukemia secondary to oncology chemotherapy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Malignant liver tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Renal cell carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Sarcoma NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Urothelial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Cognitive disturbance | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysphasia | Nervous system disorders | Non-systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Intracranial hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Non-systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope vasovagal | Nervous system disorders | Non-systematic Assessment |
| ||
| Transient ischemic attacks | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Trigeminal nerve disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Vasovagal reaction | Nervous system disorders | Non-systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Non-systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Non-systematic Assessment |
| ||
| Delusions | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
| ||
| Psychiatric disorder NOS | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Bladder perforation | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| End stage renal disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Kidney failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary tract obstruction | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urine discoloration | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Uterine hemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bronchial infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hospital acquired pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Lung cancer stage unspecified (excl metastatic tumours to lung) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SOB | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Arthroplasty of hip | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Bladder neoplasm surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Cardiac pacemaker battery replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Fracture repair | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hip arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Joint prosthesis replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Lumbar laminectomy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Revision of hip arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Total knee replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Transfusion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Wound debridement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Aortic dissection | Vascular disorders | Non-systematic Assessment |
| ||
| Arterial thromboembolism | Vascular disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Hematoma | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypovolemic shock | Vascular disorders | Non-systematic Assessment |
| ||
| Peripheral ischemia | Vascular disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anemia iron deficiency | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hemolysis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hemolytic uremic syndrome | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypoplastic marrow | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Spleen disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Aortic valve disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Heart failure, congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Non-sustained ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Paroxysmal atrial tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Phimosis | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Urachal abnormality | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Hearing impaired | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Euthyroid sick syndrome | Endocrine disorders | Non-systematic Assessment |
| ||
| Hyperparathyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Cataract | Eye disorders | Non-systematic Assessment |
| ||
| Glaucoma | Eye disorders | Non-systematic Assessment |
| ||
| Macular degeneration | Eye disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Duodenal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pain anal | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Regional ileitis aggravated | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Death from natural causes | General disorders | Non-systematic Assessment |
| ||
| Edema limbs | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Fever of unknown origin | General disorders | Non-systematic Assessment |
| ||
| Foggy feeling in head | General disorders | Non-systematic Assessment |
| ||
| Generalized edema | General disorders | Non-systematic Assessment |
| ||
| Hypothermia | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Thirst | General disorders | Non-systematic Assessment |
| ||
| Weakness | General disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Hepatic mass | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Bacterial infection due to staphylococcus aureus | Infections and infestations | Non-systematic Assessment |
| ||
| Bladder infection | Infections and infestations | Non-systematic Assessment |
| ||
| Helicobacter pylori infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hepatitis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Post procedural pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Thrush | Infections and infestations | Non-systematic Assessment |
| ||
| UTI | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Acute kidney injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Contusion of knee | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Lithium toxicity | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Meniscus tear | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural stroke | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tear of medial cartilage or meniscus of knee, current | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| BUN increased | Investigations | Non-systematic Assessment |
| ||
| Cardiac troponin I increased | Investigations | Non-systematic Assessment |
| ||
| Cardiac troponin T increased | Investigations | Non-systematic Assessment |
| ||
| INR increased | Investigations | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Troponin increased | Investigations | Non-systematic Assessment |
| ||
| Urine output decreased | Investigations | Non-systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dyslipidemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Electrolyte imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperlipidemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemic syndrome | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Other and unspecified protein-calorie malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Vitamin D deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Baker's cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Buttock pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Limbs stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in heel | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Ruptured intervertebral disc | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Cerebral hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Cognitive disturbance | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness exertional | Nervous system disorders | Non-systematic Assessment |
| ||
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Non-systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Non-systematic Assessment |
| ||
| Numbness of lower extremities | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Spasticity | Nervous system disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Transient ischemic attacks | Nervous system disorders | Non-systematic Assessment |
| ||
| Vasovagal reaction | Nervous system disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Alcoholic withdrawal symptoms | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Combative reaction | Psychiatric disorders | Non-systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Non-systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Somatization disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal calculi | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal cyst | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Retention urinary | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bullous dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pressure ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Blood transfusion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Breast reconstruction | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Fracture treatment | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hip arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hip replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hip surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Packed red blood cell transfusion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Prostate transurethral resection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Removal of other matter from skin or subcutaneous tissue | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Tooth extraction | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Total knee replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Transfusion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| DVT | Vascular disorders | Non-systematic Assessment |
| ||
| Flushing | Vascular disorders | Non-systematic Assessment |
| ||
| Hematoma | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Popliteal vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark D. Neuman, MD, MSc (Principal Investigator) | University of Pennsylvania Perelman School of Medicine | 215-746-7468 | mark.neuman@uphs.upenn.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2021 | Mar 28, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
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| Black |
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| Other or more than one race |
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| United States |
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