Sandra Ofori
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Sandra Ofori has a total of 199 co-authors. Here are the top co-authors by number of shared publications:
- Flavia Kessler Borges
Department of Medicine, McMaster University, Hamilton, ON, Canada
7 shared publications - Philip James Devereaux
Population Health Research Institute, McMaster University, Hamilton, ON, Canada
7 shared publications - Ameen Patel
Department of Medicine, McMaster University, Hamilton, Ontario, Canada
5 shared publications - Maura Marcucci
Humanitas University and IRCCS Humanitas Research Hospital
5 shared publications - David Conen
Population Health Research Institute, McMaster University, Hamilton, Canada
4 shared publications - Vikas Tandon
Department of Medicine, McMaster University, Hamilton, Ontario, Canada
4 shared publications
Latest Publications
- Open Access
- 9 June 2026
- Published by JMIR Publications Inc. in JMIR Perioperative Medicine
- Vol. 9 (1) , e90823
Association Between Complications and Death Within 30 Days After Orthopedic Surgery: Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Substudy
Background: The contemporary causes of postoperative mortality in orthopedic surgery are not well characterized. Objective: This study aimed to describe the epidemiology of postoperative complications among adult patients who underwent orthopedic surgery and inform their relationships with 30-day mortality. Methods: Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) was a prospective cohort study involving 40,004 adult patients who underwent noncardiac surgery across 28 centers in 14 countries. For the subset of patients who underwent orthopedic surgery, a Cox proportional hazards model was used to determine time-dependent associations between various surgical complications and 30-day postoperative mortality. Analyses were adjusted for preoperative and surgical variables. Results: Among 8385 patients who underwent an orthopedic surgery in VISION, 1.6% (n=132) died within 30 days of surgery. Of the 132 deaths, 63.6% (n=84) occurred in hospital during the index hospitalization, while 36.4% (n=48) occurred after discharge. The incidence of death across the subcategories of orthopedic surgery was above-knee amputation (30/221, 13.6%), internal fixation of femur (29/750, 3.9%), lower leg amputation (9/252, 3.6%), major hip or pelvic surgery (49/2898, 1.7%), major spine surgery (8/1405, 0.6%), and knee arthroplasty (7/2876, 0.2%). A total of 6 postoperative complications (myocardial injury after noncardiac surgery [MINS], major bleeding, infection without sepsis, sepsis, stroke, and atrial fibrillation) were associated with death in adjusted analyses. The greatest attributable fractions of postoperative mortality (ie, proportion of deaths in the cohort that can be attributed to each complication, if causality were established) were from MINS (1454/8385, 17.3%; hazard ratio [HR] 2.08, 95% CI 1.38‐3.14; P <.001; attributable fraction=20.6%), major bleeding (2422/8385, 28.9%; HR 1.95, 95% CI 1.34‐2.85; P <.001; attributable fraction=16.5%), and sepsis (318/8385, 3.8%; HR 6.24, 95% CI 3.85‐10.12; P <.001; attributable fraction=9.7%). Conclusions: The complications most attributable to 30-day mortality following orthopedic surgery were MINS, major bleeding, and sepsis. These findings highlight areas for further study to mitigate perioperative mortality in orthopedic surgery. MINS demonstrated the highest attributable fraction for mortality (20.6%), emphasizing the importance of appropriate MINS screening, diagnosis, and management.
- 9 June 2026
- Published by JMIR Publications Inc. in JMIR Perioperative Medicine
- Vol. 9 (1) , e90823
Open AccessAssociation Between Complications and Death Within 30 Days After Orthopedic Surgery: Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Substudy
Background: The contemporary causes of postoperative mortality in orthopedic surgery are not well characterized. Objective: This study aimed to describe the epidemiology of postoperative complications among adult patients who underwent orthopedic surgery and inform their relationships with 30-day mortality. Methods: Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) was a prospective cohort study involving 40,004 adult patients who underwent noncardiac surgery across 28 centers in 14 countries. For the subset of patients who underwent orthopedic surgery, a Cox proportional hazards model was used to determine time-dependent associations between various surgical complications and 30-day postoperative mortality. Analyses were adjusted for preoperative and surgical variables. Results: Among 8385 patients who underwent an orthopedic surgery in VISION, 1.6% (n=132) died within 30 days of surgery. Of the 132 deaths, 63.6% (n=84) occurred in hospital during the index hospitalization, while 36.4% (n=48) occurred after discharge. The incidence of death across the subcategories of orthopedic surgery was above-knee amputation (30/221, 13.6%), internal fixation of femur (29/750, 3.9%), lower leg amputation (9/252, 3.6%), major hip or pelvic surgery (49/2898, 1.7%), major spine surgery (8/1405, 0.6%), and knee arthroplasty (7/2876, 0.2%). A total of 6 postoperative complications (myocardial injury after noncardiac surgery [MINS], major bleeding, infection without sepsis, sepsis, stroke, and atrial fibrillation) were associated with death in adjusted analyses. The greatest attributable fractions of postoperative mortality (ie, proportion of deaths in the cohort that can be attributed to each complication, if causality were established) were from MINS (1454/8385, 17.3%; hazard ratio [HR] 2.08, 95% CI 1.38‐3.14; P <.001; attributable fraction=20.6%), major bleeding (2422/8385, 28.9%; HR 1.95, 95% CI 1.34‐2.85; P <.001; attributable fraction=16.5%), and sepsis (318/8385, 3.8%; HR 6.24, 95% CI 3.85‐10.12; P <.001; attributable fraction=9.7%). Conclusions: The complications most attributable to 30-day mortality following orthopedic surgery were MINS, major bleeding, and sepsis. These findings highlight areas for further study to mitigate perioperative mortality in orthopedic surgery. MINS demonstrated the highest attributable fraction for mortality (20.6%), emphasizing the importance of appropriate MINS screening, diagnosis, and management.
- Top Cited PapersOpen Access
- 8 April 2026
- Published by Oxford University Press (OUP) in European Heart Journal
- Vol. 47 (23) , 2968-2977
New-onset postoperative atrial fibrillation management and outcomes: the VISION Cardiac Surgery cohort
Background and Aims: New-onset atrial fibrillation (AF) is the most common complication of cardiac surgery. We aimed to describe the incidence of postoperative AF (POAF), its management, and its relationship to long-term outcomes in a prospective multi-centre cohort, as our current understanding comes primarily from registries and single-centre studies. Methods: VISION Cardiac Surgery was a prospective cohort of adults who underwent cardiac surgery in 12 countries. The association of POAF with outcomes occurring between 30 days and 1 year postoperatively was estimated using a multivariable Cox model adjusted for patient and operative characteristics and for antithrombotic therapies. Results: Among 12 234 patients (55.3% isolated coronary artery bypass grafting), 31.8% had POAF within 30 days of surgery. The proportion of participants with POAF who received anticoagulation alone at hospital discharge was 15.6%, 54.3% received antiplatelets alone, 23.9% received anticoagulation and antiplatelets, and 6.3% received neither; 48.8% were receiving amiodarone. At 1 year, clinical AF was detected in 6.9% of patients with POAF compared to 0.6% in those without [adjusted hazard ratio (aHR), 11.30; 95% confidence interval (CI) 8.17–15.70]. The primary composite outcome of stroke or vascular death occurred in 2.3% of patients with POAF and 1.5% in those without POAF (aHR 1.32; 95% CI 0.99–1.77). Patients with POAF had a higher risk of all-cause death (3.0% vs 1.7%; aHR 1.54; 95% CI 1.18–2.00). Conclusions: New-onset POAF occurs in a third of patients after cardiac surgery; its antithrombotic and antiarrhythmic management varies. Patients with POAF have increased risks of both clinical AF and of all-cause death in the year following surgery.
- 8 April 2026
- Published by Oxford University Press (OUP) in European Heart Journal
- Vol. 47 (23) , 2968-2977
Top Cited PapersOpen AccessNew-onset postoperative atrial fibrillation management and outcomes: the VISION Cardiac Surgery cohort
Background and Aims: New-onset atrial fibrillation (AF) is the most common complication of cardiac surgery. We aimed to describe the incidence of postoperative AF (POAF), its management, and its relationship to long-term outcomes in a prospective multi-centre cohort, as our current understanding comes primarily from registries and single-centre studies. Methods: VISION Cardiac Surgery was a prospective cohort of adults who underwent cardiac surgery in 12 countries. The association of POAF with outcomes occurring between 30 days and 1 year postoperatively was estimated using a multivariable Cox model adjusted for patient and operative characteristics and for antithrombotic therapies. Results: Among 12 234 patients (55.3% isolated coronary artery bypass grafting), 31.8% had POAF within 30 days of surgery. The proportion of participants with POAF who received anticoagulation alone at hospital discharge was 15.6%, 54.3% received antiplatelets alone, 23.9% received anticoagulation and antiplatelets, and 6.3% received neither; 48.8% were receiving amiodarone. At 1 year, clinical AF was detected in 6.9% of patients with POAF compared to 0.6% in those without [adjusted hazard ratio (aHR), 11.30; 95% confidence interval (CI) 8.17–15.70]. The primary composite outcome of stroke or vascular death occurred in 2.3% of patients with POAF and 1.5% in those without POAF (aHR 1.32; 95% CI 0.99–1.77). Patients with POAF had a higher risk of all-cause death (3.0% vs 1.7%; aHR 1.54; 95% CI 1.18–2.00). Conclusions: New-onset POAF occurs in a third of patients after cardiac surgery; its antithrombotic and antiarrhythmic management varies. Patients with POAF have increased risks of both clinical AF and of all-cause death in the year following surgery.
- 12 August 2025
- Published by Wolters Kluwer Health in Clinical Orthopaedics and Related Research
- Vol. 484 (1) , 119-128
Cemented Fixation in Arthroplasty for Hip Fractures Does Not Increase Cardiopulmonary Complications: A Secondary Analysis of the HIP ATTACK Trial
Background: Cemented fixation in arthroplasty to treat hip fractures is now widely recommended, but it is not universally used. Some surgeons may feel that the risk of bone cement implantation syndrome and its cardiopulmonary sequalae are too high, in part, because the evidence provides little detail on postoperative myocardial injury and other medical complications after cement use. Questions/purposes: We aimed to use data from the HIP ATTACK trial (an RCT in which patients with a hip fracture were randomized to accelerated time to surgery versus normal timing of surgery) for a secondary analysis to answer the following questions on arthroplasty for patients with hip fractures: (1) Are patients who undergo cemented hip arthroplasty for hip fractures more likely to experience cardiopulmonary events than patients who undergo uncemented hip arthroplasty? (2) Are patients who undergo cemented hip arthroplasty for hip fractures more likely to experience myocardial injury, identified by elevated troponin levels, than patients who undergo uncemented hip arthroplasty? Methods: We performed a post hoc analysis of the HIP ATTACK trial for a subset of patients who were treated with THA or hemiarthroplasty for a femoral neck fracture because the trial collected postoperative troponin levels to allow us to identify myocardial injury. The HIP ATTACK trial consisted of 2970 patients. We limited our source cohort to the 1049 patients who underwent hip arthroplasty and were not lost to follow-up (four patients who had undergone arthroplasty were lost to follow-up). We excluded two patients with unknown fixation and six patients with “other arthroplasty.” We limited our analysis to femoral neck fractures, which excluded 75 more patients. Of the 966 patients who received hip arthroplasty, 61% (593) had cemented fixation. Patients with cemented fixation were older than patients with cementless fixation (median [IQR] 82 (74 to 88) versus 79 (71 to 86); p = 0.003). Race was self-reported by patients and differed between patients with cemented and cementless fixation. A higher proportion of patients who received cementless fixation had undergone THA (compared with hemiarthroplasty) than patients in the cemented fixation group (24% [91] versus 11% [66]; p < 0.001). We used logistic regression to estimate the association between cement use and a composite outcome consisting of all-cause mortality and various cardiopulmonary outcomes. We included cardiopulmonary outcomes possibly associated with bone cement implantation syndrome; there were only a small number of patients who had only nonsevere outcomes. We had 80% power to detect an OR of ≥ 1.6. We adjusted for all baseline differences between both groups except for anesthesia (as it was not associated with the outcome) and duration of surgery (as it is a function of cement use). Results: After controlling for age, sex, race, and relevant comorbidity, we found that cement use was not associated with differences in the composite outcome at 90 days (OR 1.0 [95% confidence interval (CI) 0.7 to 1.4]; p = 0.99) or 1 year (OR 1.0 [95% CI 0.7 to 1.4]; p = 0.95) or with postoperative elevated troponin (OR 1.4 [95% CI 1.0 to 1.9]; p = 0.06) on Day 1. Conclusion: There was no difference in cardiopulmonary outcomes among patients with arthroplasty to treat their hip fracture by fixation method. These findings further support the recommendations to use cemented femoral fixation in THA and hemiarthroplasty for patients with hip fractures. Surgeons with limited experience with cemented femoral fixation should familiarize themselves with these skills. Future studies should assess what barriers to cemented fixation exist and how they can be mitigated. Level of Evidence: Level III, therapeutic study.
- 12 August 2025
- Published by Wolters Kluwer Health in Clinical Orthopaedics and Related Research
- Vol. 484 (1) , 119-128
Cemented Fixation in Arthroplasty for Hip Fractures Does Not Increase Cardiopulmonary Complications: A Secondary Analysis of the HIP ATTACK Trial
Background: Cemented fixation in arthroplasty to treat hip fractures is now widely recommended, but it is not universally used. Some surgeons may feel that the risk of bone cement implantation syndrome and its cardiopulmonary sequalae are too high, in part, because the evidence provides little detail on postoperative myocardial injury and other medical complications after cement use. Questions/purposes: We aimed to use data from the HIP ATTACK trial (an RCT in which patients with a hip fracture were randomized to accelerated time to surgery versus normal timing of surgery) for a secondary analysis to answer the following questions on arthroplasty for patients with hip fractures: (1) Are patients who undergo cemented hip arthroplasty for hip fractures more likely to experience cardiopulmonary events than patients who undergo uncemented hip arthroplasty? (2) Are patients who undergo cemented hip arthroplasty for hip fractures more likely to experience myocardial injury, identified by elevated troponin levels, than patients who undergo uncemented hip arthroplasty? Methods: We performed a post hoc analysis of the HIP ATTACK trial for a subset of patients who were treated with THA or hemiarthroplasty for a femoral neck fracture because the trial collected postoperative troponin levels to allow us to identify myocardial injury. The HIP ATTACK trial consisted of 2970 patients. We limited our source cohort to the 1049 patients who underwent hip arthroplasty and were not lost to follow-up (four patients who had undergone arthroplasty were lost to follow-up). We excluded two patients with unknown fixation and six patients with “other arthroplasty.” We limited our analysis to femoral neck fractures, which excluded 75 more patients. Of the 966 patients who received hip arthroplasty, 61% (593) had cemented fixation. Patients with cemented fixation were older than patients with cementless fixation (median [IQR] 82 (74 to 88) versus 79 (71 to 86); p = 0.003). Race was self-reported by patients and differed between patients with cemented and cementless fixation. A higher proportion of patients who received cementless fixation had undergone THA (compared with hemiarthroplasty) than patients in the cemented fixation group (24% [91] versus 11% [66]; p < 0.001). We used logistic regression to estimate the association between cement use and a composite outcome consisting of all-cause mortality and various cardiopulmonary outcomes. We included cardiopulmonary outcomes possibly associated with bone cement implantation syndrome; there were only a small number of patients who had only nonsevere outcomes. We had 80% power to detect an OR of ≥ 1.6. We adjusted for all baseline differences between both groups except for anesthesia (as it was not associated with the outcome) and duration of surgery (as it is a function of cement use). Results: After controlling for age, sex, race, and relevant comorbidity, we found that cement use was not associated with differences in the composite outcome at 90 days (OR 1.0 [95% confidence interval (CI) 0.7 to 1.4]; p = 0.99) or 1 year (OR 1.0 [95% CI 0.7 to 1.4]; p = 0.95) or with postoperative elevated troponin (OR 1.4 [95% CI 1.0 to 1.9]; p = 0.06) on Day 1. Conclusion: There was no difference in cardiopulmonary outcomes among patients with arthroplasty to treat their hip fracture by fixation method. These findings further support the recommendations to use cemented femoral fixation in THA and hemiarthroplasty for patients with hip fractures. Surgeons with limited experience with cemented femoral fixation should familiarize themselves with these skills. Future studies should assess what barriers to cemented fixation exist and how they can be mitigated. Level of Evidence: Level III, therapeutic study.
- Open Access
- 10 July 2025
- Published by JMIR Publications Inc. in Journal of Medical Internet Research
- Vol. 27 (1) , e78893
Correction: “Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial”
A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Study recruitment and follow-up are completed, and analysis of the study results is underway. This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569
- 10 July 2025
- Published by JMIR Publications Inc. in Journal of Medical Internet Research
- Vol. 27 (1) , e78893
Open AccessCorrection: “Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial”
A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Study recruitment and follow-up are completed, and analysis of the study results is underway. This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569
- 28 June 2025
- Published by Springer Nature
- p. 139-149
Assessing Noninferiority Randomized Controlled Surgical Trials
- 28 June 2025
- Published by Springer Nature
- p. 139-149
Assessing Noninferiority Randomized Controlled Surgical Trials
- Open Access
- 14 June 2025
- Published by JMIR Publications Inc. in JMIR Preprints
Correction: “Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial” (Preprint)
UNSTRUCTURED A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Study recruitment and follow-up are completed, and analysis of the study results is underway. This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569
- 14 June 2025
- Published by JMIR Publications Inc. in JMIR Preprints
Open AccessCorrection: “Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial” (Preprint)
UNSTRUCTURED A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Study recruitment and follow-up are completed, and analysis of the study results is underway. This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569
- Open Access
- 2 June 2025
- Published by JMIR Publications Inc. in JMIR Research Protocols
- Vol. 14 (1) , e72672
Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial
Background: A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. Objective: The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. Methods: The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Results: Study recruitment and follow-up are completed, and analysis of the study results is underway. Conclusions: This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. Trial Registration: ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569 International Registered Report Identifier (IRRID): DERR1-10.2196/72672
- 2 June 2025
- Published by JMIR Publications Inc. in JMIR Research Protocols
- Vol. 14 (1) , e72672
Open AccessImpact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial
Background: A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. Objective: The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. Methods: The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Results: Study recruitment and follow-up are completed, and analysis of the study results is underway. Conclusions: This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. Trial Registration: ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569 International Registered Report Identifier (IRRID): DERR1-10.2196/72672
- Open Access
- 12 May 2025
- Published by American Society of Hematology in Blood Advances
- Vol. 9 (15) , 3837-3844
The CLUE Post-Surgery VTE Risk Instrument for Abdominal and Pelvic Surgery: Validation of Patient Risk Factor Component
Venous thromboembolism (VTE) remains a major postoperative risk. Systematic reviews have established procedure-specific VTE risk estimates, which form one component of the CLUE Post-Surgery VTE Risk Instrument. The instrument also incorporates patient-level factors-age (≥75 years), BMI (≥35 kg/m²), and prior VTE-to stratify overall risk. However, the patient risk factor component has not been formally validated. We therefore conducted the validation using data from the VISION study, a prospective, international cohort of 11,636 patients undergoing major general abdominal, urologic, or gynecologic surgery. Thirty-day postoperative VTE incidence was analyzed using modified Poisson regression. The instrument classified patients as low (72%), medium (25%), and high (4%) risk factor categories. VTE occurred in 97 patients (0.8%). Compared to the low-risk group, the relative risks of VTE was 1.56 (95% confidence interval, 1.01-2.43) for medium-risk and 3.60 (1.90-6.83) for high-risk patients. Among patients who did not receive antithrombotic medication, relative risks increased to 1.91 for medium-risk and 5.41 for high-risk patients. The CLUE Post-Surgery VTE Risk Instrument, using three widely available patient-level factors, accurately classifies patients into substantially different categories of relative VTE risk. This validated patient component complements procedure-specific absolute risk estimates derived from prior systematic reviews. To support evidence-based thromboprophylaxis decisions the instrument is now available through an interactive online platform.
- 12 May 2025
- Published by American Society of Hematology in Blood Advances
- Vol. 9 (15) , 3837-3844
Open AccessThe CLUE Post-Surgery VTE Risk Instrument for Abdominal and Pelvic Surgery: Validation of Patient Risk Factor Component
Venous thromboembolism (VTE) remains a major postoperative risk. Systematic reviews have established procedure-specific VTE risk estimates, which form one component of the CLUE Post-Surgery VTE Risk Instrument. The instrument also incorporates patient-level factors-age (≥75 years), BMI (≥35 kg/m²), and prior VTE-to stratify overall risk. However, the patient risk factor component has not been formally validated. We therefore conducted the validation using data from the VISION study, a prospective, international cohort of 11,636 patients undergoing major general abdominal, urologic, or gynecologic surgery. Thirty-day postoperative VTE incidence was analyzed using modified Poisson regression. The instrument classified patients as low (72%), medium (25%), and high (4%) risk factor categories. VTE occurred in 97 patients (0.8%). Compared to the low-risk group, the relative risks of VTE was 1.56 (95% confidence interval, 1.01-2.43) for medium-risk and 3.60 (1.90-6.83) for high-risk patients. Among patients who did not receive antithrombotic medication, relative risks increased to 1.91 for medium-risk and 5.41 for high-risk patients. The CLUE Post-Surgery VTE Risk Instrument, using three widely available patient-level factors, accurately classifies patients into substantially different categories of relative VTE risk. This validated patient component complements procedure-specific absolute risk estimates derived from prior systematic reviews. To support evidence-based thromboprophylaxis decisions the instrument is now available through an interactive online platform.
- 28 August 2024
- Published by Elsevier in British Journal of Anaesthesia
- Vol. 133 (4) , 722-725
Perioperative randomised controlled trials: to pilot or not to pilot?
- 28 August 2024
- Published by Elsevier in British Journal of Anaesthesia
- Vol. 133 (4) , 722-725
Perioperative randomised controlled trials: to pilot or not to pilot?