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"Phelan, Rachel"
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Systematic reviews in hematopoietic cell transplantation and cellular therapy: considerations and guidance from the American Society for Transplantation and Cellular Therapy, European Society for Blood and Marrow Transplantation, and the Center for International Blood and Marrow Transplant Research late effects and quality of life working committee
2021
Systematic reviews apply rigorous methodologies to address a pre-specified, clearly formulated clinical research question. The conclusion that results is often cited to more robustly inform decision-making by clinicians, third-party payers and managed care organizations about the clinical question of interest. While systematic reviews provide a rigorous standard, they may be unfeasible when the task is to create general disease-focused guidelines comprised of multiple clinical practice questions versus a single major clinical practice question. Collaborating transplantation and cellular therapy societal committees also recognize that the quantity and or quality of reference sources may be insufficient for a meaningful systematic review. As the conduct of systematic reviews has evolved over time in terms of grading systems, reporting requirements and use of technology, here we provide current guidance in methodologies, resources for reviewers, and approaches to overcome challenges in conducting systematic reviews in transplantation and cellular therapy.
Journal Article
Sensitivity and specificity of waveform analysis for assessing postoperative epidural function
by
Hopman, Wilma M.
,
Moreira e Lima, Rodrigo
,
Mizubuti, Glenio B.
in
Adult
,
Analgesia, Epidural - methods
,
Anesthesia
2022
To characterize the accuracy of epidural waveform analysis (EWA) in assessing the functionality of thoracic epidural catheters in the immediate postoperative period (primary objective), and to determine the inter-rater reliability between EWA waveform observers (secondary outcome).
Single center, prospective diagnostic accuracy cohort study.
Post-anesthetic care unit of a university teaching hospital.
84 adult patients undergoing elective thoracic, gynecologic, vascular, urologic, or general surgery with preoperative placement of a thoracic epidural catheter for perioperative analgesia.
EWA tracings were video recorded in the immediate postoperative period through the epidural catheter in the post-anesthetic care unit.
Postoperative EWA tracings were compared with clinical assessments of the sensory block to ice produced by epidural local anesthetic in the immediate postoperative period. Additionally, intra-class correlation analysis of agreement between 3 independent (and blinded) EWA waveform observers was carried out.
Among 80 patients with thoracic epidurals who completed the study protocol, 73 demonstrated postoperative functional epidurals with sensory block to ice and 7 demonstrated non-functional epidurals. EWA yielded 65 true positives, 6 true negatives, 8 false negatives, and 1 false positive. Postoperative EWA sensitivity, specificity, positive predictive value and negative predictive value, along with the 95% confidence intervals (CI) were 89% (79–95%), 86% (42–100%), 98% (92–100%), and 43% (18–71%) respectively. Intra-class correlation between waveform assessors was 0.870 (95% CI 0.818–0.910, p < 0.001).
EWA is useful in assessing the position of thoracic epidural catheters in the immediate postoperative period, demonstrating high sensitivity and specificity as well as robust inter-rater reliability. For patients in whom sensory block to ice cannot be reliably assessed postoperatively, EWA may provide a useful adjunct for assessing epidural functionality.
•EWA is useful in assessing position of thoracic epidural catheters postoperatively.•Postoperative EWA sensitivity and specificity were 89% and 86%, respectively.•Test positive and negative predictive values were 98%, and 43%, respectively.•Intra-class correlation between independent waveform assessors was 0.870.•Postoperative EWA is useful when sensory block to ice cannot be reliably assessed.
Journal Article
Dobutamine and Goal-Directed Fluid Therapy for Improving Tissue Oxygenation in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction Surgery: Protocol for a Randomized Controlled Trial
by
Smethurst, Bethany
,
Mizubuti, Glenio B
,
Tanzola, Robert
in
Abdomen
,
Adrenergic receptors
,
Breast cancer
2023
Breast reconstruction is an integral part of breast cancer care. There are 2 main types of breast reconstruction: alloplastic (using implants) and autologous (using the patient's own tissue). The latter creates a more natural breast mound and avoids the long-term need for surgical revision-more often associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is considered the gold standard approach in autologous breast reconstruction. However, complications do occur with DIEP flap surgery and can stem from poor flap tissue perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (eg, goal-directed perioperative fluid therapy) is essential. Current perioperative fluid therapy is traditionally guided by subjective criteria, which leads to wide variations in clinical practice.
The main objective of this trial is to determine whether the use of minimally invasive cardiac output (CO) monitoring for guiding intravenous fluid administration, combined with low-dose dobutamine infusion (via a treatment algorithm), will increase tissue oxygenation in patients undergoing DIEP flap surgery.
With appropriate institutional ethics board and Health Canada approval, patients undergoing DIEP flap surgery are randomly assigned to receive CO monitoring for the guidance of intraoperative fluid therapy in addition to a low-dose dobutamine infusion (which potentially improves flap oxygenation) versus the current standard of care. The primary outcome is tissue oxygenation measured via near-infrared spectroscopy at the perfusion zone furthest from the perforator vessels 45 minutes after vascular reanastomosis of the DIEP flap. Low dose (2.5 μg/kg/hr) dobutamine infusion continues for up to 4 hours postoperatively, provided there are no associated complications (ie, persistent tachycardia). Flap oxygenation, hemodynamic parameters, and any medication-associated side effects/complications are monitored for up to 48 hours postoperatively. Complications, rehospitalizations, and patient satisfaction are also collected until 30 days postoperatively.
Funding and regulatory approvals were obtained in 2019, but the study recruitment was interrupted by the COVID-19 pandemic. As of October 4, 2023, 34 participants have been recruited. Because of the significant delays associated with the pandemic, the expected completion date was extended. We expect the study to be completed and ready for potential news release (as appropriate) and publication by July 2024. No patients have suffered any adverse effects/complications from participating in this study, and none have been lost to follow-up.
CO-directed fluid therapy in combination with a low-dose dobutamine infusion via a treatment algorithm has the potential to improve DIEP flap tissue oxygenation and reduce complications following DIEP flap breast reconstruction surgery. However, given that the investigators remain blinded to group randomization, no comment can be made regarding the efficacy of this intervention for improving tissue oxygenation at this time. Nevertheless, no patients have been withdrawn for safety concerns thus far, and compliance remains high.
Clinicaltrials.gov NCT04020172; https://clinicaltrials.gov/study/NCT04020172.
Journal Article
Cancellation of elective surgery: rates, reasons and effect on patient satisfaction
2021
The cancellation of elective surgeries is a major problem that increases wait times, exacerbates costs and can negatively affect patients, both psychologically and physically. Our objectives were to investigate the reasons for cancellations across specialties at a single centre, to compare these reasons with previous data from the same centre between 2005 and 2009 and to examine how cancellations affected patients’ lives and views of the medical system in cases when the cancellations were potentially preventable.
Cancellation records of all elective surgeries scheduled between June 1, 2012, and Jan. 31, 2016, at a medium-sized, tertiary care, academic centre were retrospectively reviewed. We evaluated the rates and reasons for cancellation and interviewed a subset of patients whose surgery was cancelled for a potentially preventable reason (i.e., operating room running late, bed shortage, emergency case took place of scheduled surgery).
Across 11 surgical specialties, 2933 of 20 881 surgeries (14.0%) were cancelled and of these, 2448 (83.5%) were for administrative or structural reasons. Compared with the data collected previously for general, gynecological and urological procedures, cancellation rates increased from 8.1% to 11.8%. Although patients reported inconvenience, they were generally satisfied with the availability and the quality of the health care they received.
Consistent with the previous study, our data suggest that most cancellations occur because of administrative or structural processes that are potentially preventable. Targeting these processes may help to reduce cancellations for elective surgeries and thereby improve economic efficiency and patient outcomes.
L’annulation des chirurgies électives est un problème majeur qui allonge les temps d’attente, fait gonfler les coûts et peut affecter négativement les patients, tant psychologiquement que physiquement. Nos objectifs étaient de découvrir les raisons des annulations dans les diverses spécialités d’un seul centre, afin de comparer ces raisons à des données antérieures du même centre recueillies entre 2005 et 2009 et d’examiner en quoi les annulations affectent la vie des patients et leur perception du système médical dans les cas où les annulations auraient pu être évitées.
Les dossiers d’annulation de toutes les chirurgies électives entre le 1er juin 2012 et le 31 janvier 2016 dans un centre hospitalier universitaire de soins tertiaires de taille moyenne ont été analysés de manière rétrospective. Nous avons évalué les taux d’annulation et les motifs, et interrogé un groupe de patients dont la chirurgie a été annulée pour des raisons potentiellement évitables (p. ex., retards au bloc opératoire, manque de lits, priorisation de cas plus urgents).
Entre les 11 spécialités chirurgicales, 2933 des 20 881 chirurgies (14,0 %) ont été annulées et parmi elles, 2448 (83,5 %) pour des raisons administratives ou structurelles. Comparativement aux données précédemment recueillies pour les interventions générales, gynécologiques et urologiques, les taux d’annulation ont augmenté de 8,1 % à 11,8 %. Même si les patients ont déploré des inconvénients, ils se sont généralement déclarés satisfaits de la qualité des soins reçus et de leur accessibilité.
Comme lors de l’étude précédente, nos données suggèrent que les causes les plus fréquentes d’annulation sont liées à des marches à suivre administratives ou structurelles qui sont potentiellement évitables. Cibler ces marches à suivre pourrait contribuer à réduire le nombre d’annulations de chirurgies électives et améliorer de ce fait l’efficience économique et les résultats chez les patients.
Journal Article
Developmental differences in health-related quality of life in adolescent and young adult cancer survivors
2020
Purpose
Adolescents and young adults (AYAs) experience developmental transitions. AYA survivors of cancer are at risk for chronic health conditions due to treatment. This study examined developmental differences in AYA survivors’ health-related quality of life (HRQOL) between age groups and compared to population norms.
Methods
HRQOL was assessed in AYA survivors of cancer (diagnosed before age 30) in long-term follow-up. Cancer survivors who were 12–39 years old at survey completion and completed therapy ≥ 2 years ago were included. HRQOL was assessed using the PedsQL™ and FACT.
Results
Sample size was 155 survivors. PedsQL™ school functioning was worse in 15–17 year olds compared to 12–14 year olds (66.35 vs 77.60,
p
= 0.012). Compared to population norms, PedsQL™ outcomes were only worse in survivors’ school functioning. Survivors’ 18–39 years old had FACT scores that were better than population norms for overall HRQOL (91.33 vs 80.1,
p
< 0.001), and in physical (24.22 vs 22.7,
p
< 0.001), social (23.46 vs 19.1,
p
< 0.001), and functional well-being (22.94 vs 18.5,
p
< 0.001). Regression analysis identified that survivors who were < 15 years old and had not relapsed, and survivors who were 15–18 years old and had ≥ 2 late effects are at highest risk of lower HRQOL. For older survivors the highest risk group for lower HRQOL were < 21 years old at survey completion, > 7 years old at diagnosis and > 6 years post therapy.
Conclusion
A trend in school functioning issues in older adolescent survivors emerged. Older survivors show improved HRQOL when compared to the general population. Those further off therapy are at risk of poor HRQOL.
Journal Article
Competencies for proficiency in basic point-of-care ultrasound in anesthesiology: national expert recommendations using Delphi methodology
by
Shatenko, Sergiy
,
Ho, Anthony M.-H.
,
Mizubuti, Glenio B.
in
Anesthesiology
,
Cardiology
,
Critical Care Medicine
2024
Purpose
Point-of-care ultrasound (POCUS) allows for rapid bedside assessment and guidance of patient care. Recently, POCUS was included as a mandatory component of Canadian anesthesiology training; however, there is no national consensus regarding the competencies to guide curriculum development. We therefore aimed to define national residency competencies for basic perioperative POCUS proficiency.
Methods
We adopted a Delphi process to delineate relevant POCUS competencies whereby we circulated an online survey to academic anesthesiologists identified as POCUS leads/experts (
n
= 25) at all 17 Canadian anesthesiology residency programs. After reviewing a list of competencies derived from the Royal College of Physicians and Surgeons of Canada’s National Curriculum, we asked participants to accept, refine, delete, or add competencies. Three rounds were completed between 2022 and 2023. We discarded items with < 50% agreement, revised those with 50–79% agreement based upon feedback provided, and maintained unrevised those items with ≥ 80% agreement.
Results
We initially identified and circulated (Round 1) 74 competencies across 19 clinical domains (e.g., basics of ultrasound [equipment, nomenclature, clinical governance, physics]; cardiac [left ventricle, right ventricle, valve assessment, pericardial effusion, intravascular volume status] and lung ultrasound anatomy, image acquisition, and image interpretation; and clinical applications [monitoring and serial assessments, persistent hypotension, respiratory distress, cardiac arrest]). After three Delphi rounds (and 100% response rate maintained), panellists ultimately agreed upon 75 competencies.
Conclusion
Through national expert consensus, this study identified POCUS competencies suitable for curriculum development and assessment in perioperative anesthesiology. Next steps include designing and piloting a POCUS curriculum and assessment tool(s) based upon these nationally defined competencies.
Journal Article
Relationship between work performance and quality of life in long-term survivors of pediatric and adolescent hematopoietic cell transplant
2024
PurposeTo assess work status, missed time at work (absenteeism), work performance (presenteeism), and their relationship with quality of life (QOL) among long-term survivors of childhood hematopoietic cell transplant (HCT).MethodsA single-center cross-sectional survey study of adult survivors of childhood allogeneic HCT (performed between 1985 and 2010). Work and QOL data were captured using the World Health Organization Health and Work Performance Questionnaire and the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS), respectively. Higher absenteeism and presenteeism scores meant higher missed time at work and productivity, respectively. PROMIS domains were scored on a T-score metric with a mean score of reference population at 50 and standard deviation of 10. Univariate linear regression was performed to study factors associated with increase in PROMIS scores.ResultsForty-four survivors completed the survey. Median ages at HCT and survey were 11 years (interquartile range [IQR] 7–13) and 30 years (IQR 26–34), respectively. Seventy-three percent were working, 23% were unemployed, and 4% were students. Employed survivors reported less pain and sleep disturbance. Higher absolute presenteeism was associated with less pain interference and more satisfaction with social roles and activities and physical function. Higher relative presenteeism was associated with less cognitive concerns.Conclusions and Implications for Cancer SurvivorsWe found significant associations between survivors’ work status, performance, and QOL. Our findings provide an important insight on the implications of work outcomes on HCT survivors’ physical, mental, and social health and emphasize the importance of longitudinal assessment of work status, performance, and QOL.
Journal Article
Patient engagement in hematopoietic stem cell transplantation and cell therapy: a survey by the EBMT patient engagement task force & transplantation complications working party
by
Penack, Olaf
,
Boreland, William
,
Bolaños, Natacha
in
Bone marrow transplantation
,
Cell therapy
,
Cognitive ability
2024
The EBMT (European Blood and Marrow Transplantation Society) aims to connect patients, the scientific community, and other stakeholders to improve hematopoietic stem cell transplantation and cellular therapy outcomes. We performed a cross-sectional online survey to understand the perceptions regarding Patient Reported Outcomes (PROs) and Patient Active Involvement in Research (PAIR) in over 800 stakeholders (n = 813). Patients (n = 278) and health care professionals (HCPs) (n = 351) were compared. We observed high openness for EBMT PRO collection (n = 680, 84.5% across stakeholders’ groups; patients n = 256, 93.1% versus HCPs n = 273, 78.4% [p < 0.001]) and PAIR (n = 702, 87.3% across stakeholder groups; patients n = 256, 92.4% versus HCPs n = 296, 85.8% [p = 0.009]), with a significantly higher proportion of patients expressing interest compared to HCPs. Priority domains for PROs data-collection identified were the assessment of symptom experience, psychosocial and cognitive functioning. The most important issues for patients specifically were the data-collection of PROs reflecting cognitive function, the option of reporting data at home, the importance of identifying actionable targets to improve their recovery, and receiving feedback on their input when participating in research projects. Our multistakeholder approach suggests an added value to embracing patient engagement in the development of meaningful research and service design within the transplantation and cellular therapy community.
Journal Article
Plasma bupivacaine levels (total and free/unbound) during epidural infusion in liver resection patients: a prospective, observational study
by
Burjorjee, Jessica
,
Nanji, Sulaiman
,
Mizubuti, Glenio B
in
Anesthesia
,
anesthesia, local
,
Body mass index
2022
IntroductionLiver resection patients may be at an increased risk of local anesthetic (LA) toxicity because the liver is essential for metabolizing LA and producing proteins (mainly α1-acid glycoprotein (AAG)) that bind to it and reduce the free (and pharmacologically active/toxic) levels in circulation. The liver resection itself, manipulation during surgery, and pre-existing liver disease may all interfere with normal hepatic protein synthesis and result in an attenuation of the increased AAG (a positive acute-phase protein) that normally occurs postoperatively. The purpose of this study was to determine whether the AAG response is attenuated postoperatively following liver resection and whether patients approach toxicity thresholds with continuous postoperative epidural infusion of bupivacaine.MethodsProspective, observational study with blood drawn preoperatively, in the postanesthetic care unit, on postoperative day (POD) 2, and prior to discontinuation of epidural analgesia on POD3/POD4. Plasma was analyzed for total and unbound bupivacaine via liquid chromatography–mass spectrometry and AAG via ELISA. Signs/symptoms of local anesthetic systemic toxicity (LAST), pain, and sedation scores were also recorded.ResultsFor the 19 patients completed, total plasma bupivacaine was correlated with total administered, but unbound levels were not associated with the total administered. Unlike non-hepatectomy surgery where unbound LA plasma levels remain stable (or decrease) with continuous postoperative epidural administration, we observed an overall increase. Several patients approached toxicity thresholds and 47% reported at least one symptom of LAST, but no epidurals were discontinued because of LAST. In contrast to the AAG response reported following major non-liver surgery where AAG levels increase twofold, we observed a reduction until POD2 and the magnitude was proportional to resection weight.DiscussionOur results are supported by the literature in suggesting that major liver resection patients may be at an increased vulnerability for LAST. Factors such as the extent of liver disease, resection and intraoperative blood loss should be considered when using continuous postoperative epidural infusion of bupivacaine and vigilance should be used in monitoring, for signs/symptoms of LAST, even for those subtle and non-specific. Future research will be required to verify these findings.Trial registration number NCT03145805.
Journal Article
Return to school practices after hematopoietic cell transplantation: a survey of transplant centers in the United States
by
Devine, Steven
,
Baker, K. Scott
,
Choi, Sung Won
in
Cell therapy
,
Decision making
,
Hematopoietic stem cells
2024
To understand transplant center recommendations on return-to-school timing and related support for hematopoietic cell transplant (HCT) survivors, we conducted a two-phase, cross-sectional, web-based survey: In Phase I, medical directors of pediatric HCT centers from the National Marrow Donor Program/ Be The Match Registry were asked regarding the availability of a return to school standardized operating procedure (SOP). In Phase II, HCT physician members of the Pediatric Transplantation and Cellular Therapy Consortium were approached to study inter-physician practice variability regarding return to school post-HCT, factors affecting their decision-making, and support provided by HCT centers for return to school. Out of 46 respondents in Phase I (55% response rate), 28 (61%) reported having a SOP. Wide variations in recommendations were noted in 12 received SOPs. In Phase II, 122 physicians (60 centers) responded (30.6% response rate). The majority (60%) recommended autologous HCT recipients return to school within 6 months post-HCT but 65% recommended allogeneic HCT recipients return to school after 6 months or once off immunosuppression. Our findings indicate a lack of consensus within and across HCT centers regarding recommended return to school timing and underscore need for a guideline to standardize this process to ensure patient safety and re-integration into school.
Journal Article