A catalyst for transforming health systems and person-centred care: Canadian national position statement on patient-reported outcomes.

Background: Patient-reported outcomes (pros) are essential to capture the patient's perspective and to influence care. Although pros and pro measures are known to have many important benefits, they are not consistently being used and there is there no Canadian pros oversight. The Position Statement presented here is the first step toward supporting the implementation of pros in the Canadian health care setting. Methods: The Canadian pros National Steering Committee drafted position statements, which were submitted for stakeholder feedback before, during, and after the first National Canadian Patient Reported Outcomes (canpros) scientific conference, 14-15 November 2019 in Calgary, Alberta. In addition to the stakeholder feedback cycle, a patient advocate group submitted a section to capture the patient voice. Results: The canpros Position Statement is an outcome of the 2019 canpros scientific conference, with an oncology focus. The Position Statement is categorized into 6 sections covering 4 theme areas: Patient and Families, Health Policy, Clinical Implementation, and Research. The patient voice perfectly mirrors the recommendations that the experts reached by consensus and provides an overriding impetus for the use of pros in health care. Conclusions: Although our vision of pros transforming the health care system to be more patient-centred is still aspirational, the Position Statement presented here takes a first step toward providing recommendations in key areas to align Canadian efforts. The Position Statement is directed toward a health policy audience; future iterations will target other audiences, including researchers, clinicians, and patients. Our intent is that future versions will broaden the focus to include chronic diseases beyond cancer.

The physician's Achilles heel-surviving an adverse event.

Background: Of hospitalized patients in Canada, 7.5% experience an adverse event (ae). Physicians whose patients experience aes often become second victims of the incident. The present study is the first to evaluate how physicians in Canada cope with aes occurring in their patients. Methods: Survey participants included oncologists, surgeons, and trainees at the Foothills Medical Centre, Calgary, AB. The surveys were administered through REDCap (Research Electronic Data Capture, version 9.0: REDCap Consortium, Vanderbilt University, Nashville, TN, U.S.A.). The Brief cope (Coping Orientation to Problems Experienced) Inventory, the ies-r (Impact of Event Scale-Revised), the Causal Dimension Scale, and the Institutional Punitive Response scale were used to evaluate coping strategies, prevalence of post-traumatic stress, and institutional culture with respect to aes. Results: Of 51 responses used for the analysis, 30 (58.8%) came from surgeons and 21 (41.2%) came from medical specialists. On the ies-r, 54.9% of respondents scored 24 or higher, which has been correlated with clinically concerning post-traumatic stress. Individuals with a score of 24 or higher were more likely to report self-blame (p = 0.00026) and venting (p = 0.042). Physicians who perceive institutional support to be poor reported significant post-traumatic stress (p = 0.023). On multivariable logistic regression modelling, self-blame was associated with an ies-r score of 24 or higher (p = 0.0031). No significant differences in ies-r scores of 24 or higher were observed between surgeons and non-surgeons (p = 0.15).The implications of aes for physicians, patients, and the health care system are enormous. More than 50% of our respondents showed emotional pathology related to an ae. Higher levels of self-blame, venting, and perception of inadequate institutional support were factors predicting increased post-traumatic stress after a patient ae. Conclusions: Our study identifies a desperate need to establish effective institutional supports to help health care professionals recognize and deal with the emotional toll resulting from aes.

Guidelines on the use of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with peritoneal surface malignancy arising from colorectal or appendiceal neoplasms.

To meet the needs of patients, Canadian surgical and medical oncology leaders in the treatment of peritoneal surface malignancies (psms), together with patient representatives, formed the Canadian HIPEC Collaborative Group (chicg). The group is dedicated to standardizing and improving the treatment of psm in Canada so that access to treatment and, ultimately, the prognosis of Canadian patients with psm are improved. Patients with resectable psm arising from colorectal or appendiceal neoplasms should be reviewed by a multidisciplinary team including surgeons and medical oncologists with experience in treating patients with psm. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy should be offered to appropriately selected patients and performed at experienced centres. The aim of this publication is to present guidelines that we recommend be applied across the country for the treatment of psm.

Synoptic operative record for point of care outcomes: a leap forward in knowledge translation.

INTRODUCTION: Modern information technology coupled with synoptic methodology allows point of care, real time outcomes generation. Our objective was to review province-wide breast cancer surgery outcomes from a prospective synoptic operative record to demonstrate its value in knowledge translation. METHODS: All synoptic reports for breast cancer procedures from 2006 until March 2010 were reviewed and descriptively analyzed. Key outcomes included frequency of breast cancer procedures captured over time, methods of breast cancer detection, clinical staging, method of axillary staging, breast conservation and reconstruction rates. Further analysis involved important decision-making for mastectomy and resource allocation for surgery. RESULTS: Four thousand nine hundred fifty-five breast cancer procedures were recorded synoptically; greater than 80% of cases provincially. Method of breast cancer detection was 49%, 45% and 4% by screening radiology, patient or family, and physician, respectively. Pathologic diagnoses were via core or mammotome biopsy in 94%; nearly half of all patients were clinical Stage I at time of operation. Overall rate of breast conservation was 48%. Of the 65% who had no contra-indication to breast conservation surgery, 76% had breast conservation and 4% had primary reconstruction. Of those having mastectomy, one third were due to patient choice. Seventy-nine percent had sentinel node staging, 18% had full axillary dissection and 3% had no axillary staging. CONCLUSION: A new paradigm of creating medical records using synoptic electronic templates allows prospective outcomes generation at point of care by the surgeon which is unparalleled in its depth of surgical detail capturing surgical decision-making.

Opening the black box of cancer surgery quality: WebSMR and the Alberta experience.

A web-based synoptic operative report, the WebSMR (Surgical Medical Record), was developed to define and improve the quality of cancer surgery. Surgeons accurately record the essential steps of an operation including important decision-making in an analyzable format. Outcomes can be reviewed with provincial aggregates for quality improvement and maintenance of certification. Future synoptic pathology and follow-up templates will open the "black box" of surgical processes to define quality indicators for the improvement of cancer outcomes.

Polypharmacy: misleading, but manageable.

The percentage of the population described as elderly is growing, and a higher prevalence of multiple, chronic disease states must be managed concurrently. Healthcare practitioners must appropriately use medication for multiple diseases and avoid risks often associated with multiple medication use such as adverse effects, drug/drug interactions, drug/disease interactions, and inappropriate dosing. The purpose of this study is to identify a consensus definition for polypharmacy and evaluate its prevalence among elderly outpatients. The authors also sought to identify or develop a clinical tool which would assist healthcare practitioners guard against inappropriate drug therapy in elderly patients. The most commonly cited definition was a medication not matching a diagnosis. Inappropriate was part of definitions used frequently. Some definitions placed a numeric value on concurrent medications. Two common definitions (ie, 6 or more medications or a potentially inappropriate medication) were used to evaluate polypharmacy in elderly South Carolinians (n = 1027). Data analysis demonstrates that a significant percentage of this population is prescribed six or more concomitant drugs and/or uses a potentially inappropriate medication. The findings are 29.4% are prescribed 6 or more concurrent drugs, 15.7% are prescribed one or more potentially inappropriate drugs, and 9.3% meet both definitions of polypharmacy used in this study. The authors recommend use of less ambiguous terminology such as hyperpharmacotherapy or multiple medication use. A structured approach to identify and manage inappropriate polypharmacy is suggested and a clinical tool is provided.

Preoperative chemoradiation and flap reconstruction provide high local control and low wound complication rates for patients undergoing limb salvage surgery for upper extremity tumors.

BACKGROUND AND OBJECTIVES: Neoadjuvant protocols in the management of upper extremity sarcoma have improved local control rates but have been associated with high complication rates. We present a refinement of the Eilber protocol using judicious preoperative chemoradiation, limb salvage surgery, and flap coverage to achieve high local control rates with acceptable wound healing complications. METHODS: Patients presenting with upper extremity neoplasms from 1986 to 2002 were treated with a modified Eilber protocol, consisting of 3 days of adriamycin (30 mg/day) and sequential radiotherapy (300 cGy/day for 10 days). Limb salvage surgery with flap coverage where needed was performed 4-8 weeks later. Patients were followed prospectively for recurrence. RESULTS: Fifty-three consecutive patients with upper extremity tumors were treated and followed for a mean of 6.1 years. This cohort included 44 sarcomas and nine non-metastasizing, locally aggressive tumors. There were two local recurrences (3.8%). Limb salvage was achieved in all patients. Flaps were required in 43.4% of patients. Major complications occurred in 11%, were all flap related (partial flap loss, venous congestion), and went on to heal promptly with treatment. CONCLUSION: This modified Eilber protocol achieved 96% local control for upper extremity tumors with a wound complication rate of 11%. The liberal use of flaps of resulted in healed, stable wounds in all patients.

Use of tissue expanders and pre-operative external beam radiotherapy in the treatment of retroperitoneal sarcoma.

INTRODUCTION: We report our experience of treating retroperitoneal sarcoma (RPS) using pre-operative external beam radiotherapy (EBRT) in combination with radical resectional surgery from 1990 to 2005. METHODS: Twenty-eight primary and 10 recurrent tumors were identified from a prospective database. RESULTS: The resection rate was 71% overall; 82% in primary (23/28) and 40% (4/10) in recurrent cases. EBRT was administered preoperatively in 25 patients, postoperatively in 1, and palliatively in 11. In 33 patients a saline-filled tissue expander was inserted into the abdomen before radiotherapy to displace small bowel from the radiation field. 4,500-5,000 cGy was administered in fractions of 180-200 cGy over a 5-week period; surgery followed 6-8 weeks later. Expander insertion was associated with minimal morbidity; 31/37 patients received a dose of 4,000 cGy or more (median 4,650 cGy). Median resected tumor diameter was 13 cm, and a median of three adjacent organs was resected per patient. Complete macroscopic resection was achieved in 25/27 patients (93%); R0 in 9 (33%) and R1 in 13 (48%) (microscopic margins unclear in 5). There was no postoperative mortality. Tumors were high-grade in 20 patients, low-grade in 14 and ungraded in 4. Actuarial 5- and 10-year survival for all patients was 74 and 60%. For operable primary tumors, the 5-year survival and disease-free rates were 90 and 80%. In four patients with operable recurrent tumors, median disease-free interval was 91 months (27-160). In the 11 inoperable cases, median survival after radiotherapy was 48 months (9-77). CONCLUSIONS: We conclude that a combination of pre-operative tissue expander placement, high-dose EBRT and radical resectional surgery can achieve acceptable morbidity, extended survival and low long-term recurrence in patients with RPS. STATISTICS: Median (interquartile range).

Autologous diaphragm reconstruction with the pedicled latissimus dorsi flap.

The latissimus dorsi (LD) muscle has been previously described to repair diaphragmatic defects, but as a "reverse" flap, relying on secondary blood supply from the perforating lumbar vessels rather than primary inflow from the dominant thoracodorsal artery. We report resection of a retroperitoneal synovial sarcoma, with reconstruction of the hemidiaphragm using the LD rotated on its primary neurovascular bundle. By using the dominant pedicle, the vascularity of the flap is improved, minimizing the chance of flap tip loss. Maintaining an intact nerve supply prevents atrophy. As the distal origin of the LD is broad and flat, it is ideally suited for diaphragm repair. A latissimus-sparing thoracotomy incision is required to enable this method of diaphragm reconstruction.

Education is the key to quality of surgery for rectal cancer.

Surgical quality assurance is a central issue in the treatment of rectal cancer and has led to substantial improvements in sphincter preservation, local control, and overall survival. Education or training as well as volume of practice are often cited as the major predictors of quality outcomes. While volume is a simple measure to analyze, it is likely a superficial or surrogate measure of quality surgery. It has been conclusively demonstrated that education, from total mesorectum excision workshops to nation-wide educational initiatives are effective methods of improving quality of care for the rectal cancer patient. New methods of quality assurance and improvement are being developed including prospective quality registers, the synoptic operative report, and pathology audits. It is imperative that improved measures of quality, other than volume, be implemented to audit our own practices, hospitals and regions with the goal of identifying issues that will improve outcomes for rectal cancer patients.

Long-term results of a prospective surgical trial comparing 2 cm vs. 4 cm excision margins for 740 patients with 1-4 mm melanomas.

BACKGROUND: The Intergroup Melanoma Surgical Trial began in 1983 to examine the optimal surgical margins of excision for primary melanomas of intermediate thickness (i.e., 1-4 mm). There is now a median 10-year follow-up. METHODS: There were two cohorts entered into a prospective multi-institutional trial: (1) 468 patients with melanomas on the trunk or proximal extremity who randomly received a 2 cm or 4 cm radial excision margin and (2) 272 patients with melanomas on the head, neck, or distal extremities who received a 2 cm radial excision margin. RESULTS: A local recurrence (LR) was associated with a high mortality rate, with a 5-year survival rate of only 9% (as a first relapse) or 11% (anytime) compared with an 86% survival for those patients who did not have a LR (P < .0001). The 10-year survival for all patients with a LR was 5%. The 10-year survival rates were not significantly different when comparing 2 cm vs. 4 cm margins of excision (70% vs. 77%) or comparing the management of the regional lymph nodes (observation vs. elective node dissection). The incidences of LR were the same for patients having a 2 cm vs. 4 cm excision margin regardless of whether the comparisons were made as first relapse (0.4% vs. 0.9%) or at anytime (2.1% vs. 2.6%). When analyzed by anatomic site, the LR rates were 1.1% for melanomas arising on the proximal extremity, 3.1% for the trunk, 5.3% for the distal extremities, and 9.4% for the head and neck. The most profound influence on LR rates was the presence or absence of ulceration; it was 6.6% vs. 1.1% in the randomized group involving the trunk and proximal extremity and was 16.2% vs. 2.1% in the non-randomized group involving the distal extremity and head and neck (P < .001). A multivariate (Cox) regression analysis showed that ulceration was an adverse and independent factor (P = .0001) as was head and neck melanoma site (P = .01), while the remaining factors were not significant (all with P > .12). CONCLUSION: For this group of melanoma patients, a local recurrence is associated with a high mortality rate, a 2-cm margin of excision is safe and ulceration of the primary melanoma is the most significant prognostic factor heralding an increased risk for a local recurrence.

Management of the axilla in early breast cancer: is it time to change tack?

The standard surgical treatment of the axilla in patients with early breast cancer is about to undergo a radical change. Although axillary dissection is an excellent procedure for both staging and local control, particularly in the clinically positive axilla, it has considerable morbidity and may understage a significant proportion of patients, because it will usually miss micrometastases that can occur in approximately 10% of 'node negative' patients. An increasing number of patients whose tumours are either non-invasive (ductal carcinoma in situ; DCIS), micro-invasive, tubular cancers or low-grade T1a tumours without lymphovascular invasion may be spared axillary surgery because the risk of axillary disease is 0-3%. Many studies, both prospective trials and large retrospective series, show that axillary radiotherapy alone provides similar local control rates to axillary dissection in patients with clinically negative axillas. Primary treatment of the axilla with radiotherapy alone, however, does not allow appropriate staging. Sentinel lymph node biopsy is being increasingly used in patients with breast cancer to provide this information. When a sentinel node is identified it is equal to or better than axillary dissection for staging the axilla and, if the node is positive, it will help select patients who should then proceed to further axillary surgery or axillary radiotherapy. Although sentinel lymph node biopsy is being rapidly adopted in many centres worldwide, the results of randomized controlled trials are needed before it can be recommended as the standard of care.

Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm). Intergroup Melanoma Surgical Trial.

BACKGROUND: Ten- to 15-year survival results were analyzed from a prospective multi-institutional randomized surgical trial that involved 740 stages I and II melanoma patients with intermediate thickness melanomas (1.0 to 4.0 mm) and compared elective (immediate) lymph node dissection (ELND) with clinical observation of the lymph nodes as well as prognostic factors that independently predict outcomes. METHODS: Eligible patients were stratified according to tumor thickness, anatomical site, and ulceration, and then prerandomized to either ELND or nodal observation. By using Cox stepwise multivariate regression analysis, the independent predictors of outcome were tumor thickness (P < .001), the presence of tumor ulceration (P < .001), trunk site (P = .003), and patient age more than 60 years (P = .01). RESULTS: Overall 10-year survival was not significantly different for patients who received ELND or nodal observation (77% vs. 73%; P = .12). Among the prospectively stratified subgroups of patients, 10-year survival rates favored those patients with ELND, with a 30% reduction in mortality rate for the 543 patients with nonulcerated melanomas (84% vs. 77%; P = .03), a 30% reduction in mortality rate for the 446 patients with tumor thickness of 1.0 to 2.0 mm (86% vs. 80%; P = .03), and a 27% reduction in mortality rate for 385 patients with limb melanomas (84% vs. 78%; P = .05). Of these subgroups, the presence or absence of ulceration should be the key factor for making treatment recommendations with regard to ELND for patients with intermediate thickness melanomas. CONCLUSIONS: These long-term survival rates from patients treated at 77 institutions demonstrate that ulceration and tumor thickness are dominant predictive factors that should be used in the staging of stages I and II melanomas, and confer a survival advantage for these subgroups of prospectively defined melanoma patients.

Locally recurrent rectal cancer: role of composite resection of extensive pelvic tumors with strategies for minimizing risk of recurrence.

Locally recurrent cancer of the rectum has been under-recognized as a complication, although it affects up to 40% of patients treated with surgery alone. Even in the best centers, rates average 25%. While radiotherapy may reduce recurrence, it is now apparent that total mesorectal excision is the most effective modality, with rates as low as 5%. The dramatic decrease in local recurrence can also be linked to increased survival in prospective studies, an effect more significant than any adjuvant therapy. The options, however, for patients with locally recurrent cancer are limited. Fifteen percent of patients with this complication die without systemic spread. Salvage by surgery offers potential cure. Other than anastomotic recurrences that can be locally resected, the best approach for long-term survival is an extensive surgical procedure requiring en bloc removal of adjacent organs and pelvic structures-so-called composite resection. With careful selection, 30% 5-year survival can be achieved and palliation is considerable, with 50% long-term local control. Intraoperative radiotherapy and brachytherapy, and/or preoperative chemoradiation may provide better results in future. Newer techniques of coloanal anastomosis, improved urinary diversion, and myocutaneous flaps for perineal reconstruction radically reduce the morbidity of these procedures. The approach to recurrent rectal cancer requires a sophisticated multidisciplinary team to obtain optimum results.

Quality of cancer surgery: challenges and controversies.

It is generally accepted that the quality of cancer surgery delivered to a patient impacts the patient's overall prognosis significantly. Often, the fact that all surgery and surgeons are not equal is not considered. Furthermore, it should not be assumed that surgeons who perform a particular operation frequently perform it better. Using breast cancer, melanoma, and colorectal cancer as examples, this article illustrates that proper surgical education and training are paramount in assuring that both the selection and delivery of a particular procedure is appropriate in the management of cancer.

The surgeon as a prognostic factor in the management of pancreatic cancer.

Improved results for pancreatic resection have been attributed to the concentration of pancreatic surgery in high-volume centers. The evidence supporting a relationship between hospital case volume and operative mortality for pancreatectomy is reviewed. The surgeon's case volume does not appear to influence mortality independently, but other surgeon-related characteristics, like specialized training, have not been examined. More research is needed to elucidate the factors that have contributed to reduced mortality for this complex surgery.