After a rigorous review process, the following projects were selected for funding.
Project Title: Refining Appropriateness of care using a novel prognostic biomarker for papillary thyroid cancer
Principal Investigator: Dr Oliver Bathe, Professor of Surgery and Oncology, Cummings School of Medicine, University of Calgary. Also affiliated with Arnie Charbonneau Cancer Institute and Tom Baker Cancer Center, Alberta Health Services.
Abstract: Thyroid cancer is the 8th most common cancer by prevalence, and incidence has been increasing by >6%/year since 1992. Papillary thyroid cancer (PTC) accounts for most thyroid cancers, and the rising incidence of thyroid cancer can be almost entirely attributed to an increased detection of small PTC’s. PTC usually has a favorable prognosis with high cure rates. However, approximately 10% of PTC’s display a more aggressive behavior and are often resistant to conventional adjuvant therapies such as radioactive iodine. Given the increasing number of PTC cases (and the potential burden on health care costs), accurate prognostication is becoming increasingly important. Accurately estimating prognosis and risk of recurrence will avoid unnecessary surgery, investigations and follow-up in individuals with a good prognosis, and will direct more extensive surgery, adjuvant therapies and prolonged follow-ups to those who need it.
Currently, multiple clinical risk systems exist to predict prognosis in PTC, including the MACIS prognostic score, which predicts mortality, and the American Thyroid Association (ATA) Risk Stratification System, which predicts disease recurrence. Currently, adjuvant therapy is directed by the ATA system. Although these indices have been validated in clinical studies, the proportion of variance explained (a statistical measure of how well a staging system can predict an outcome of interest, such as recurrence) is suboptimal and accounts for only a small proportion of the uncertainty in PTC prognosis. This inability to reliably determine prognosis may be because they do not integrate the risk associated with a tumor’s molecular profile. Using novel algorithm we developed, we have identified 44 genes that most highly impact PTC prognosis. The genes were identified by over 7.5 million tests of prognostic effects in a group of 335 patients with PTC, then validated in another 167 patients. From this, we have designed a clinical assay.
We hypothesize that prognostication using our novel transcriptional signature will more accurately identify the subgroup of patients with low risk of recurrence who will require minimal follow-up tests and will not require adjuvant therapy. The following experimental approach will be used to test this hypothesis:
Project Title: Pediatric hand fractures requiring specialist referral- Derivation and Validation of a clinical prediction rule
Principal Investigator: Dr. Frankie Fraulin is currently the Site Chief of Surgery at the Alberta Children’s Hospital and the Section Head of Pediatric Surgery in the Department of Surgery, University of Calgary Cumming School of Medicine and Alberta Health Services.
Abstract: Pediatric hand fractures are common, but few fractures require surgery and they have lower morbidity when compared to hand fractures in adults. For these reasons, non-surgical pediatric hand fractures are often perceived to be over-referred and may represent a potential misuse of health care resources. There are also no agreed upon guidelines for when a pediatric hand fracture should be referred to a hand specialist. Our team has already completed a cross-sectional study of 1,200 consecutive pediatric hand fractures referred to the Alberta Children’s Hospital (ACH) hand clinic from January 2013 to December 2014. Of the 1,200 patients, only 30.8% (n=369) were deemed to actually require specialist care and only 9.0% (n=108) of patients required surgery.
The objectives of the proposed research are:
Phase 1 Derivation of Clinical Prediction Rule: Univariate analysis based on log binomial regression models will be performed to identify predictors that are associated with the need for specialist care. The significant predictor variables from this analysis (a<0.05) will be used to develop a multivariable prediction rule.
Phase 2 Internal Validation: Internal validation of the prediction model will be performed using bootstrapping techniques to assess the discrimination and calibration of the prediction model. We will aim for sensitivity greater than 95% and a negative likelihood ratio of less than 0.1 with the least complicated, most clinically relevant combination of predictors.
Expected Results: Only a few predictors will be clinically relevant and the prediction rule will be a simple, straight-forward tool for referring physicians to triage pediatric hand fractures into different strata. Each stratum will then be managed by the appropriate health care provider(s) in a more efficient, expeditious manner.
Project Title: Enhanced Recovery in Cardiac Surgery: Initiation and Evaluation of Clinical Pathway Implementation
Principal Investigator: Dr. Alexander Gregory is an Assistant Professor in the Department of University of Calgary Cumming School of Medicine and Alberta Health Services.
Abstract: Enhanced Recovery After Surgery or ERAS® is a global effort to deliver standardized perioperative care resulting in reduced complications, improved patient experience, and efficient use of health care resources. Alberta Health Services has been a national leader in this area, dedicating significant resources and time towards achieving optimum patient care. There are currently no established enhanced recovery programs for cardiac surgery, despite the high level of health care resource utilization this population represents. With the assistance of local ERAS experts, we have engaged in a multinational group to begin the formation of ERAS guidelines for CV surgery. In order to contribute foundational evidence towards this cause, we propose the design and implementation of a set of initial high-impact intervention bundles to apply to a select group of cardiac surgery patients.
The results of our interventions will 1) help patients and the healthcare system now, 2) develop inter-disciplinary relationships for development of further ERAS bundles, 3) gain local experience in the implementation of intervention bundles, and 4) generate data which can then be used to assist other centers around the globe.
The next cycle of SEED Grant Call For Applications will be available early March 2019.
Project Title: Validation of the Caregiver Burden Inventory (CBI) in the Left Ventricular Assist Device (LVAD) population: Determinants of Caregiver Strain
Grantee: Bronte Diduck – Bachelor of Arts in Psychology, Concordia University of Edmonton.
Supervision: Dr Cheryl Mack is a Pediatric and Adult Cardiac Anesthesiologist at the Stollery Children’s Hospital and Mazankowski Alberta Heart Institute at the University of Alberta. Her focus is medical ethics and the philosophy of medicine with a particular interest in the ethics and evidence of medical innovation.
Regarding caregiver burden, one American study notes that although both the LVAD patients and their caregivers underwent evaluation by a social worker prior to LVAD implantation, no formal tool to quantify caregiver burden was used. In the future, such a measure may be helpful in predicting durability of the caregiver commitment. Moreover, very little is known about caregiver burden and its determinants in the LVAD caregiver population.
Knowledge of caregiver burden would help identify at-risk caregivers who may benefit from additional support from the LVAD team and others. Other studies exploring the problems experienced by caregivers of heart failure patients have emphasized similar domains of caregiver burden in heart failure, in terms of physical, social and psychological well-being. These domains of burden are all explored by the CBI that could complement disease-specific measures of caregiver burden in heart failure.
To our knowledge, no Canadian studies exist that validate the CBI in LVAD patients. Identifying patient and caregiver characteristics and potential gaps in community care that contribute to caregiver strain will allow for opportunities to improve patient outcomes. This project will capture the experience of caregivers and elucidate the strain experienced by caregivers of LVAD patients. Sub-goals of this study include:
Project Title: Intersection of Catastrophizing, Mood Disorders, and Sex in Rotator Cuff Surgical Patients: An Exploratory Study
Grantee: Eric Gibson – Bachelor in Science in Kinesiology, University of Calgary
Supervision: Dr Marlis Sabo is a Shoulder Reconstruction Surgeon based at the Bone and Joint Clinic, South Health Campus, Calgary, Alberta.
Rotator cuff syndrome is a common, painful and sometimes disabling condition that affects approximately 180,000 Canadians each year. While many patients achieve adequate symptom relief through conservative management, some patients experience refractory symptoms and elect to undergo surgical treatment of their condition. 80-90% of patients report a satisfactory outcome after surgery for rotator cuff syndrome. While much work has been done to improve the technical factors regarding this type of surgery, the incomplete success of this operation may also be influenced by non-technical patient-specific factors. Recent literature has identified that a catastrophizing coping style is associated with a higher risk of negative patient-reported outcomes among patients undergoing hip and knee replacement and hand surgery. The first steps in this research program are to describe the prevalence of the pain catastrophizing coping style in a pre-operative rotator cuff patient cohort and how catastrophizing is linked to patient-reported disease severity scores. Secondary outcome measures will include an examination of any associations between pain catastrophizing tendency, gender and underlying mood disorders. We hypothesize that the study group will be quite heterogeneous with respect to these factors, and that increased catastrophizing will be associated with greater patient-reported disease burden.
This prospective cohort study will include 184 eligible patients aged 35-75 recruited from the practices of two fellowship-trained shoulder surgeons who are undergoing surgery for unilateral rotator cuff syndrome. Exclusion criteria include significant cervicogenic pain or the presence of a significant chronic pain disorder, prior rotator cuff surgery in the operative shoulder, and the inability to complete the questionnaires in English. Baseline characteristics such as patient demographics, disease severity (assessed via the Western Ontario Rotator Cuff [WORC] score), general health status (per SF-36), presence of mood disorder symptoms (Hospital Anxiety and Depression Scale [HADS]), and pain coping style (Pain Catastrophizing Score [PCS]) will be collected. Each of these patient-reported scoring instruments have been validated for the purposes described. All data will be de-identified and stored securely on site and in a password-protected REDCap database housed within the University of Calgary Clinical Research Unit (CRU).
To date, all 184 patients have been recruited. Analysis of baseline data is in progress, and interim data analysis is planned for Summer/Fall 2018 (final follow-up is expected to be complete by the end 2019 as this cohort will be followed for 12 months post-operatively). Relationships between catastrophizing score and disease severity, and relationships between mood disorder symptoms, known mood disorder diagnoses, and disease severity will be determined with descriptive statistics and univariate analyses. In anticipation of planning future interventional research, we have also engaged operative shoulder patients about how they would best access health-related educational resources so that any future interventions are accessible and relevant to our patients. 116 patients have completed the survey to date. Data will be analyzed, synthesized and prepared for dissemination to stakeholders once the patient cohort reaches 150. The goal of this survey is to understand how patients would like to access information about their surgery and recovery.
With this data, we hope to be better prepared to provide interventions and information for future shoulder surgery patients. Knowledge gained from this study in rotator cuff patients will add to the growing body of literature regarding the effects of patient factors in outcomes of surgery. While the first phase of this research is observational, the wealth of data gathered is intended for immediate application to design of the next phase of work looking at targeted interventions for high-risk patient groups identified by this phase. The patient education survey is specifically targeted at determination of effective pathways to get information to patients. In addition to laying important groundwork for future interventional research, the greater study will help surgeons better identify patients who may struggle with recovery from surgery, as well as those who may benefit from more individualized care.
Project Title: Intersection of Catastrophizing, Mood Disorders, and Sex in Rotator Cuff Surgical Patients: An Exploratory Study
Grantee: Courtney Grotski – Doctor of Medicine - University of Alberta
Supervision: Dr Suresh Nayar is an associate professor in the Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta and as a maxillofacial prosthodontist at the Institute for Reconstructive Sciences in Medicine (iRSM), Alberta. He is also an adjunct associate professor with the Faculty of Rehabilitation Medicine, University of Alberta.
Surgical design and simulation (SDS) has allowed head and neck reconstruction surgery following tumour resection to become more efficient and precise. SDS is a tool to assist surgeons and maxillofacial prosthodontists to visualize the bony defect and the oral rehabilitation burden and allows virtual surgical manoeuvres prior to surgery. In Edmonton, a team of clinicians have pioneered innovative surgical techniques using SDS and the fibula graft which have improved treatment times for head and neck oncology patients.
Technological advances notwithstanding, the digital workflow still offers challenges in the timescale it takes to plan the SDS. Planning of the oncologic surgery is carried out by an interdisciplinary team of maxillofacial prosthodontists, head and neck surgeons and surgical design simulationists. Currently, following anterior jaw oncologic resection surgery, surgeons in Alberta perform reconstruction using either a two (V-shaped) or three (U-shaped) strut reconstruction design. One of the challenges in the pre-surgical SDS planning is accurately ascertaining the number of fibula bone struts required for maxillary and mandibular anterior jaw reconstruction. This critical phase is completed through a time-consuming and labour-intensive trial and error process, which could often take several attempts.
Although it would be naïve to consider that a templated workflow can be used for all patients, there is still an opportunity to template part of the SDS workflow. If the SDS workflow can be part templated, then a significant proportion of the planning can be done prior to, with final verification by the clinicians.
The aim of this project is to assess the SDS planning that has been carried out to date to determine if there is a correlation between the number of fibula bone struts used in reconstruction (V-shaped vs. U-shaped) of the anterior jaw and the maxillary and mandibular intercanine distance.
Sample size – Patients with head and neck oncology diagnosis who have undergone anterior jaw reconstruction using SDS will be included. 20 patients with a two strut plan (V-shaped) and 20 patients with a three-strut plan (U-shaped) will be assessed.
Data collection: The SDS plan will be assessed to determine the number of bony struts in the reconstruction. The preoperative dentition will be assessed to determine the distance between the canine teeth.
Data analysis: Once the above data is obtained, it will be analysed to see if there is a correlation between the intercanine distance and number of bony struts used for the anterior jaw reconstruction.
It is hoped that with this research, once the intercanine distance is available, a prediction as to whether the anterior jaw reconstruction can be carried out with a three-strut plan or needs a two strut plan can be made. Further prospective trial will need to be carried out to validate this; however, if the outcome is as expected, an algorithm can be created which will not only simplify the digital workflow but also reduce the time taken in the SDS process and hopefully reduce the time to oncology surgery for patients.
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