Primary care providers' experiences with and perceptions of personalized genomic medicine.

OBJECTIVE: To assess primary care providers' (PCPs') experiences with, perceptions of, and desired role in personalized medicine, with a focus on cancer. DESIGN: Qualitative study involving focus groups. SETTING: Urban and rural interprofessional primary care team practices in Alberta and Ontario. PARTICIPANTS: Fifty-one PCPs. METHODS: Semistructured focus groups were conducted and audiorecorded. Recordings were transcribed and analyzed using techniques informed by grounded theory including coding, interpretations of patterns in the data, and constant comparison. MAIN FINDINGS: Five focus groups with the 51 participants were conducted; 2 took place in Alberta and 3 in Ontario. Primary care providers described limited experience with personalized medicine, citing breast cancer and prenatal care as main areas of involvement. They expressed concern over their lack of knowledge, in some circumstances relying on personal experiences to inform their attitudes and practice. Participants anticipated an inevitable role in personalized medicine primarily because patients seek and trust their advice; however, there was underlying concern about the magnitude of information and pace of discovery in this area, particularly in direct-to-consumer personal genomic testing. Increased knowledge, closer ties to genetics specialists, and relevant, reliable personalized medicine resources accessible at the point of care were reported as important for successful implementation of personalized medicine. CONCLUSION: Primary care providers are prepared to discuss personalized medicine, but they require better resources. Models of care that support a more meaningful relationship between PCPs and genetics specialists should be pursued. Continuing education strategies need to address knowledge gaps including direct-to-consumer genetic testing, a relatively new area provoking PCP concern. Primary care providers should be mindful of using personal experiences to guide care.

Real world costs and cost-effectiveness of Rituximab for diffuse large B-cell lymphoma patients: a population-based analysis.

BACKGROUND: Current treatment of diffuse-large-B-cell lymphoma (DLBCL) includes rituximab, an expensive drug, combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy. Economic models have predicted rituximab plus CHOP (RCHOP) to be a cost-effective alternative to CHOP alone as first-line treatment of DLBCL, but it remains unclear what its real-world costs and cost-effectiveness are in routine clinical practice. METHODS: We performed a population-based retrospective cohort study from 1997 to 2007, using linked administrative databases in Ontario, Canada, to evaluate the costs and cost-effectiveness of RCHOP compared to CHOP alone. A historical control cohort (n = 1,099) with DLBCL who received CHOP before rituximab approval was hard-matched on age and treatment intensity and then propensity-score matched on sex, comorbidity, and histology to 1,099 RCHOP patients. All costs and outcomes were adjusted for censoring using the inverse probability weighting method. The main outcome measure was incremental cost per life-year gained (LYG). RESULTS: Rituximab was associated with a life expectancy increase of 3.2 months over 5 years at an additional cost of $16,298, corresponding to an incremental cost-effectiveness ratio of $61,984 (95% CI $34,087-$135,890) per LYG. The probability of being cost-effective was 90% if the willingness-to-pay threshold was $100,000/LYG. The cost-effectiveness ratio was most favourable for patients less than 60 years old ($31,800/LYG) but increased to $80,600/LYG for patients 60-79 years old and $110,100/LYG for patients ≥ 80 years old. We found that post-market survival benefits of rituximab are similar to or lower than those reported in clinical trials, while the costs, incremental costs and cost-effectiveness ratios are higher than in published economic models and differ by age. CONCLUSIONS: Our results showed that the addition of rituximab to standard CHOP chemotherapy was associated with improvement in survival but at a higher cost, and was potentially cost-effective by standard thresholds for patients <60 years old. However, cost-effectiveness decreased significantly with age, suggesting that rituximab may be not as economically attractive in the very elderly on average. This has important clinical implications regarding age-related use and funding decisions on this drug.

The value of collecting population-based cancer stage data to support decision-making at organizational, regional and population levels.

The stage of a patient's cancer at diagnosis is essential to predict the prognosis and plan the treatment. Since 2008, stage data have been collected on all Ontario patients with breast, colorectal, lung and prostate cancers and are linked to other data collected by Cancer Care Ontario. Here, an analysis of such data is presented. How it can be used to assess the value of screening programs, inform resource allocation, evaluate compliance with treatment guidelines, compare survival trends and enhance the spectrum of cancer control activities across the province is demonstrated. International comparisons can also be made.

Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening.

OBJECTIVE: In late 2006, Cancer Care Ontario launched a quality improvement initiative to implement routine screening with the Edmonton Symptom Assessment System (ESAS) for cancer patients seen in fourteen Regional Cancer Centres throughout the province. METHODS: A central team: created a provincial project plan and management and evaluation framework; developed common tools and provided expert coaching and guidance, provincial data analysis, progress reporting and program evaluation. Regional Steering Committees and Improvement teams were accountable for planning and coordination within each region and supported by a funded Regional Improvement Coordinator. A hybrid model for quality improvement facilitated process improvements and uptake of screening. RESULTS: Challenges to implementation included: lack of consensus on the chosen screening tool, lack of guidance for assessment or management of high scores, concern of inadequate time or resources to address issues identified by the screening, data entry was labour intensive, resistance to change and challenges to the traditional care model. Essential components for success were: centralized project management, a person dedicated to implementation of the project locally, clinical champions, clearly identified aims, monthly regional data reporting and implementation of quality improvement methodologies with expectations for performance. To achieve screening aims many centres engaged all members of the team, examined the roles of the different members and reorganized workflow and responsibilities and changed booking times. In March 2010, approximately 25,000 ESAS's were completed in the regional cancer centres across Ontario, with 60% of lung cancer patients and almost 40% of all other cancer patients who visited the Regional Cancer Centres screened. CONCLUSION: Routine physical and psychological distress screening is possible within regional cancer centres. Although considerable effort and investment is required, it is worthwhile as it helps create a culture that is more patient-centered.

Determining resource intensity weights in ambulatory chemotherapy related to nursing workload.

Ontario cancer programs aim to deliver high-quality nursing care and treatment that is safe for patients and staff. The reality of health care is that financial constraints, inherent in the delivery of care, require that funding mechanisms count not only the cost of drugs, but factors such as pharmacy and nursing human resource costs. While some organizations have developed patient classification systems to measure nursing intensity and workload, these systems apply primarily to inpatient populations, and are fraught with numerous challenges, such as the need for nurses to document to justify the workload required for care. The purpose of this paper is to outline the methodology and engagement of nurses to develop regimen-based resource intensity weights that can be applied to ambulatory chemotherapy suites. The methodology included determination of workload related to nursing time to prepare, teach, counsel and assess patients, as well as time to gather supplies, access lines, monitor, manage adverse reactions, manage symptoms and document care. Resource intensity weights provide better measures of the complexity of care required by cancer patients in ambulatory settings.

The crucial role of clinician engagement in system-wide quality improvement: the Cancer Care Ontario experience.

In 2004, Cancer Care Ontario's (CCO) role changed from providing direct cancer service to oversight, with a mission to improve the performance of the cancer system by driving quality, accountability and innovation in all cancer-related services. Since then, CCO has built a model for province-wide quality improvement and oversight--the Performance Improvement Cycle--that exemplifies the key elements of the Excellent Care for All Act, 2010. While ensuring that quality of the cancer system is by necessity a continuous process, the approach taken thus far has achieved measurable results and will continue to form the basis of CCO's future work. Clinician engagement has been critical to the success of CCO's approach to quality oversight and improvement. CCO uses a variety of formal and informal clinical engagement structures at each step of the Performance Improvement Cycle, and has developed operational processes to support quality improvement, and educational and mentorship programs to build clinician leadership capacity in that area. An example of sustained quality improvement in system performance is illustrated in a case study of the surgical treatment of prostate cancer. The improvement was achieved with strong collaboration across CCO's surgery and pathology clinical programs, with support from informatics staff.

A ten-year history: the Cancer Quality Council of Ontario.

One of the longest-established quality oversight organizations in Canadian healthcare, the Cancer Quality Council of Ontario (CQCO) is an advisory group formed in 2002 by the Ministry of Health and Long-Term Care. Although quasi-independent from Cancer Care Ontario (CCO), the council was established to provide advice to CCO and the ministry in their efforts to improve the quality of cancer care in the province. The council is composed of a multidisciplinary group of healthcare providers, cancer survivors and experts in the areas of oncology, health system policy and administration, governance, performance measurement and health services research. Its mandate is to monitor and report publicly on the performance of the Ontario cancer system and to motivate improvement through national and international benchmarking. Since its formation, the council has played an evolving role in improving the quality of care received by Ontario cancer patients. This article will briefly describe the origins and founding principles of the CQCO, its changing role in monitoring quality and its relationship with CCO.

Outcomes of surveillance mammography after treatment of primary breast cancer: a population-based case series.

GOAL: To ascertain outcomes of surveillance mammography (SM) following treatment of early stage unilateral primary breast cancer (PBC) in a population based case series. METHODS: Random samples from all 12,279 women having breast surgery within 4 months after diagnosis of PBC, between July 1991 and December 1993 in Ontario, were drawn from a database created by deterministic linkage of PBC files from the Ontario Cancer Registry (OCR) with episodes of breast surgery extracted from the hospital Discharge Abstract Database (DAD), and mammography from the Ontario physician billings database (OHIP). Among women having >or=1 episode(s) of breast surgery subsequent (SBS) to the date of diagnosis up to December 2000, a sample of 1,200/5,064 (23.7%) was drawn, and among women with no SBS, a sample of 400/7,215 (5.5%). Among these two samples, operative, pathology, and mammography reports were abstracted from original charts. Treatments were abstracted and categorized. Women with complete data for Stages 1 and 2 unilateral PBC were included. From the subsequent surgery sample, 609/1,200 (50.8%) were excluded because of simultaneous or sequential bilateral breast cancers or mastectomies within 6 months, missing stage information, Stage 3 or 4 PBC, or missing primary charts. From the no subsequent surgery sample, 90/400 (22.5%) were excluded by the same criteria. Episodes of bilateral 2-view X-ray mammography, beginning >or=6 months after the diagnosis of unilateral PBC, and if multiple, at least 11 months apart, and not prompted by a clinical concern or symptom, were classified as SM. We confirmed episodes of cancer recurrence within the ipsilateral conserved breast (CRICB) and metachronous contralateral primary breast cancer (CPBC) >or=6 months after the diagnosis of the unilateral PBC from original operative and pathology reports. We used Cox models to describe the association of exposure to >or=1 episode(s) of SM with the risk of death from breast cancer among the study population, and separately among women experiencing CRICB or CPBC. RESULTS: Eligible women comprising 591/1,200 and 310/400 produced a combined case series of 901/1,600 (56.3%). Women with >or=1 episode(s) of SM numbered 721/901 (80.0%). We confirmed 84 CRICB events among 584 women initially treated by lumpectomy (14.4%), and 49 CPBC events among all 901 women in the study population (5.4%). Among women having >or=1 episode(s), the 25th percentile of observed follow up was 1,631 days, the 50th, 4,287 days, and the 75th 5,011 days. Among women without any SM, the 25th percentile of observed follow-up was 440 days, the 50th, 891 days, and the 75th, 1,849 days. Hazard ratio (HR) for death due to breast cancer associated with >or=1 episode of SM was 0.28 (95% CI 0.22-0.37), adjusted for age, stage, type of surgery, adjuvant chemotherapy, and tamoxifen. Among 84/584 women with CRICB, unadjusted HR = 0.36 (95%CI 0.13, 1.00) and among 49/901 women with CPBC, unadjusted HR = 0.86 (0.20-3.77). CONCLUSION: SM was associated with a significant reduction in the hazard for breast cancer death. Among women who experienced CRICB, the reduction was of borderline significance, and the reduction was not significant among women who experienced CPBC.

Creating a system for performance improvement in cancer care: Cancer Care Ontario's clinical governance framework.

BACKGROUND: Good governance, clinician engagement, and clear accountabilities for achieving specific outcomes are crucial components for improving the quality of care at both an organizational and health system level. METHODS: This article describes the benefits and results reported by Cancer Care Ontario (CCO) in transforming from a direct provider of cancer services to an organization whose responsibilities include improving the quality of care across the province's cancer system. The significant challenges in establishing accountability in the absence of direct operational authority are discussed. Case examples illustrate how the structures and processes created through CCO's clinical governance framework achieved measurable improvements in cancer care outcomes. RESULTS: Challenges in establishing accountability were addressed through the creation of a clinical governance framework that integrated clinical accountability with administrative accountability in an ongoing performance improvement cycle. The performance improvement cycle includes four key steps: (1) the collection of system-level performance data and the development of quality indicators, (2) the synthesis of data, evidence, and expert opinion into clear clinical and organizational guidance, (3) knowledge transfer through a coordinated program of clinician engagement, and (4) a comprehensive system of performance management through the use of contractual agreements, financial incentives, and public reporting. CONCLUSIONS: CCO has succeeded in developing a clinical governance and performance improvement system that measures and improves access to care in the treatment phase of the care continuum. Future efforts will need to focus on expanding quality improvement initiatives to all phases of cancer care, measuring the appropriateness of care, and improving the measurement and management of the patient cancer care experience.

Standardized synoptic cancer pathology reporting: a population-based approach.

Cancer pathology reports contain information which is critical for patient management and for cancer surveillance, resource planning, and quality purposes. The College of American Pathologists (CAP) has defined scientifically validated content of checklists that form the basis for synoptic cancer pathology reporting. We outline how the CAP standards were implemented in a large Canadian province over a 3-year period resulting in improvements in rates of synoptic reporting and completeness of cancer pathology reporting.

Triple-negative breast cancer: clinical features and patterns of recurrence.

PURPOSE: To compare the clinical features, natural history, and outcomes for women with "triple-negative" breast cancer with women with other types of breast cancer. EXPERIMENTAL DESIGN: We studied a cohort of 1,601 patients with breast cancer, diagnosed between January 1987 and December 1997 at Women's College Hospital in Toronto. Triple-negative breast cancers were defined as those that were estrogen receptor negative, progesterone receptor negative, and HER2neu negative. The prognostic significance of triple-negative breast cancer was explored. RESULTS: The median follow-up time of the 1,601 women was 8.1 years. One hundred and eighty of 1,601 patients (11.2%) had triple-negative breast cancer. Compared with other women with breast cancer, those with triple-negative breast cancer had an increased likelihood of distant recurrence (hazard ratio, 2.6; 95% confidence interval, 2.0-3.5; P < 0.0001) and death (hazard ratio, 3.2; 95% confidence interval, 2.3-4.5; P < 0.001) within 5 years of diagnosis but not thereafter. The pattern of recurrence was also qualitatively different; among the triple-negative group, the risk of distant recurrence peaked at approximately 3 years and declined rapidly thereafter. Among the "other" group, the recurrence risk seemed to be constant over the period of follow-up. CONCLUSIONS: Triple-negative breast cancers have a more aggressive clinical course than other forms of breast cancer, but the adverse effect is transient.

Shifting clinical accountability and the pursuit of quality: aligning clinical and administrative approaches.

This paper presents a narrative review of the literature on clinical accountability, and draws particularly on England's experience establishing "clinical governance" as a base to examine the establishment of a clinical accountability framework for cancer services in Ontario. The review suggests that clinical governance and accountability approaches that actively mesh clinical and administrative approaches at both system and local levels are more likely to be effective in improving quality of care.

Ontario, Canada: using networks to integrate palliative care province-wide.

Ontario, a Canadian province, identified the lack of coordination, integration, and consistency of end-of-life care services as barriers to quality palliative care. To address these barriers, various governmental, organizational, and community-level initiatives were implemented. The Ministry of Health and Long-Term Care enacted an End-of-Life Care Strategy in 2005 aimed at shifting care from acute settings to appropriate alternate settings of care; enhancing client-centered and interdisciplinary service capacity; and improving access, coordination, and consistency of services. Crucial to accomplishing the strategy was the establishment of End-of-Life Networks within health care planning regions. The networks were instrumental in developing end-of-life care service delivery models in the various regions, bringing key stakeholders together toward a common vision, and building strong collaborations across providers and settings. Cancer Care Ontario, an organization dedicated to improving cancer care at the regional and provincial levels, also leads improvements in palliative care through the implementation of a palliative strategy for cancer patients aimed at improved measurement of quality indicators, increased use of evidence and standards, and increased efficiency and access to care. A regional network of organizations in Southeastern Ontario created a quality improvement project, the Palliative Care Integration Project (PCIP), which disseminated common symptom assessment tools, collaborative care plans, and evidence-based guidelines across the continuum of care. The PCIP was embraced by key stakeholders across the province as a model intervention to better coordinate, integrate, and standardize palliative care service delivery, and is currently being spread across all regions of the province.

How equitable is access to treatment for lung cancer patients? A population-based review of treatment practices in Ontario.

AIM: Guideline concordance is one of the metrics used by the Cancer Quality Council of Ontario and Cancer Care Ontario to assess the quality of cancer care and to drive quality improvement. MATERIALS & METHODS: The rates for lung cancer surgical resection and concordance with the Cancer Care Ontario postoperative adjuvant chemotherapy (AC) guideline were assessed by health region during two time periods (2010-2011 and 2012-2013) according to five equity measures (age, sex, neighborhood income, location of residence and size of immigrant population). RESULTS: Of the patients with stage I/II NSCLC, 52.2% to 63.0% underwent surgical resection in the province of Ontario, Canada; for patients with stage IIIA disease, the rate was 26.4%. The probability of a surgical resection decreased substantially with age; only 26.9% of those with potentially resectable (stage I-IIIA) disease over 80 years underwent surgery. The use of postoperative AC increased modestly over the time of the study but the rate of use varied widely by health region (34.6 to 84.6%). Patients in rural areas were as likely to receive AC as urban dwellers; however, older aged patients (≥65 years) and those from the lowest income neighborhoods were significantly less likely to receive AC. CONCLUSION: Surgical rates and the use of AC vary by health region in Ontario and by age and level of neighborhood income despite universal access in a publicly funded health care system. The reasons for this variance are unclear but warrant further study.Presented in part at the 15th World Conference on Lung Cancer, Sydney, Australia, 27-30 October 2013.

Helping patients make informed choices: a randomized trial of a decision aid for adjuvant chemotherapy in lymph node-negative breast cancer.

BACKGROUND: In recent years, patients have indicated a desire for more information about their disease and to be involved in making decisions about their care. We developed an aid called the "Decision Board" to help clinicians inform patients with lymph node-negative breast cancer of the risks and benefits of adjuvant chemotherapy. We determined whether adding the Decision Board to the medical consultation improved patient knowledge and satisfaction compared with the medical consultation alone. METHODS: Between October 1995 and March 2000, 176 women with lymph node-negative breast cancer who were candidates for adjuvant chemotherapy were randomly assigned to receive the Decision Board plus the medical consultation (83 patients) or the medical consultation alone (93 patients). One week after the consultation, patients completed a questionnaire assessing their knowledge about breast cancer and chemotherapy. Satisfaction with decision making was assessed 1 week and 3, 6, and 12 months after randomization, and differences between groups were analyzed by a repeated measures analysis of variance. All statistical tests were two-sided. RESULTS: Patients in the Decision Board arm were better informed about breast cancer and adjuvant chemotherapy than patients in the control arm (mean knowledge score = 80.2 [on a scale of 0-100], 95% confidence interval [CI] = 77.1 to 83.3, and 71.7, 95% CI = 69.0 to 74.4, respectively; P<.001). Over the entire study period, satisfaction with decision making was higher for patients in the Decision Board arm than for patients in the control arm (P =.032). There was no statistically significant difference between the two groups in the number of patients who chose adjuvant chemotherapy (77% and 70% for patients in the Decision Board arm and those in the control arm, respectively; P =.303). CONCLUSION: When making decisions regarding adjuvant chemotherapy, patients with early breast cancer who had been exposed to the Decision Board had better knowledge of the disease and treatment options and greater satisfaction with their decision making than those who received the standard consultation.

Randomized phase III study of fludarabine phosphate versus cyclophosphamide, vincristine, and prednisone in patients with recurrent low-grade non-Hodgkin's lymphoma previously treated with an alkylating agent or alkylator-containing regimen.

PURPOSE: To compare in a phase III study the safety and efficacy of fludarabine to that of cyclophosphamide, vincristine, and prednisone (CVP) in recurrent, low-grade, non-Hodgkin's lymphoma after previous response to systemic treatment. PATIENTS AND METHODS: Patients were randomized to fludarabine (25 mg/m(2) intravenously on days 1 to 5, every 28 days) or CVP (cyclophosphamide 750 mg/m(2) and vincristine 1.2 mg/m(2) both intravenously on day 1 and prednisone 40 mg/m(2) orally on days 1 to 5, every 21 days). The primary outcome assessed was progression-free survival (PFS); secondary outcomes included treatment-free survival (TFS), overall survival (OS), treatment-related toxicity, and quality of life (QoL) according to the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 version 1.0 instrument. RESULTS: Ninety-one patients were randomized, 47 to fludarabine and 44 to CVP. There was no difference in response rates, with 64% (complete response [CR], 9%) for fludarabine versus 52% (CR, 7%) for CVP (P =.72). With a median follow-up of 42 months, median PFS (11 months v 9.1 months; P =.03) and TFS (15 months v 11 months; P =.02) were superior in patients receiving fludarabine. No difference in median overall survival was detected (57 months for fludarabine v 44 months for CVP; P =.95). Three patients receiving fludarabine died of treatment-related toxicity compared with none of the patients receiving CVP. Peripheral neuropathy and alopecia were more common with CVP. Patients receiving fludarabine had higher scores for social function (P =.008); no other differences in QoL were detected. CONCLUSION: In recurrent low-grade lymphoma, fludarabine improves PFS, TFS, and social function scores in comparison with CVP but does not improve OS.

Quality of life in a randomized trial of group psychosocial support in metastatic breast cancer: overall effects of the intervention and an exploration of missing data.

PURPOSE: To evaluate the effect of a standardized group psychosocial intervention on health-related quality of life (HrQOL) in women with metastatic breast cancer and to explore the effect of missing data in HrQOL analyses. PATIENTS AND METHODS: Between 1993 and 1998, seven Canadian centers randomly assigned 235 eligible women to participate in a weekly, 90-minute, therapist-led support group that adhered to principles of supportive-expressive (SE) therapy or to a control arm (no SE). All women received educational material and any type of medical or psychosocial care deemed necessary. HrQOL data were prospectively collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) at baseline, 4, 8, and 12 months. The primary HrQOL analyses compared scores in the two study arms. Analyses were limited to women with appropriate baseline HrQOL information (n = 215). RESULTS: Baseline EORTC QLQ-C30 scores were not different between the two study arms (all P >.05). Primary analysis of all subscales failed to show a significant influence of the intervention on HrQOL (all P >.05). There was a significant deterioration over time in several functional scales of the EORTC QLQ-C30: global (P =.03), physical (P =.0002), role (P =.01), and cognitive functioning (P =.04); and in symptom scales: dyspnea (P =.007), appetite loss (P =.04), and fatigue (P =.003); these changes were independent of randomization allocation. Results were similar in additional analyses of overall HrQOL using a variety of approaches to handling missing data. CONCLUSION: Supportive-expressive group therapy in patients with metastatic breast cancer does not appear to influence HrQOL, as measured by the EORTC QLQ-C30.

A prospective, non-randomised phase 1-2 trial of VACOP-B with filgrastim support for HIV-related non-Hodgkin's lymphoma.

Non-Hodgkin's lymphoma (NHL) remains an important complication of associated HIV infection despite advances in antiretroviral therapy (ART), and the optimum chemotherapy regimen for this disease remains to be defined. A dose-escalation trial was performed to determine the maximum tolerated doses of etoposide and doxorubicin as part of the 12-week VACOP-B regimen, supported by filgrastim (r-metHuG-CSF). Patients with aggressive histology HIV-related NHL who were previously untreated with chemotherapy, and who had no active opportunistic infection were eligible for the study. Chemotherapy consisted of cyclophosphamide 350 mg/m2, vincristine 2 mg, bleomycin 10 U/m2; and prednisone 100 mg q2 days x 12 weeks, with increasing doses of doxorubicin 25-50 mg/m2 and etoposide 25-50 mg/m2 intravenously and 50-100 mg/m2 orally. Central nervous system prophylaxis (intrathecal cytarabine 50 mg x 4 doses), antifungal, and Pneumocystis carinii prophylaxis were used, and filgrastim was administered to prevent neutropenic complications. One dose level was expanded to permit the concomitant use of ART. Endpoints were determination of maximum tolerated dose of doxorubicin and etoposide, treatment tolerability, and survival. Forty-seven patients were enrolled, most with diffuse large-cell or immunoblastic NHL. Protocol-defined maximum tolerated dose was not reached and the limits of dose-limiting toxicity were not exceeded, even in patients receiving ART. Thirty-two cycles (4.9%) were delayed >6 days because of toxicity; 30 patients (64%) completed all 12 weeks of treatment. After completion of therapy, 14 patients had a complete response (30%), and 4 had a partial response (8%). Median time to progression was 9 months. At 42 months, progression-free survival was 25% and overall survival was 28%.

Development of a patient decision aid for choice of surgical treatment for breast cancer.

PURPOSE: A patient decision aid for the surgical treatment of early stage breast cancer was developed and evaluated. The rationale for its development was the knowledge that breast conserving therapy (lumpectomy followed by breast radiation) and mastectomy produce equivalent outcomes, and the current general agreement that the decision for the type of surgery should rest with the patient. METHODS: A decision aid was developed and evaluated in sequential pilot studies of 18 and 10 women with newly diagnosed breast cancer who were facing a decision for breast conserving therapy or mastectomy. Both qualitative (general reaction, self-reported anxiety, clarity, satisfaction) and quantitative (knowledge and decisional conflict) measures were assessed. RESULTS: The decision aid consists of an audiotape and workbook and takes 36 min to complete. Based on qualitative comments and satisfaction ratings, 17 of 18 women reported a positive reaction to the decision aid, and all 18 reported that it helped clarify information given by the surgeon. Women did not report an increase in anxiety and 17 of 18 women were either satisfied or very satisfied with the decision aid. CONCLUSION: This pilot study supports the hypothesis that this decision aid may be a helpful adjunct in the decision for surgical management of early stage breast cancer. We are currently conducting a randomized trial of the decision aid versus a simple educational pamphlet to evaluate its efficacy as measured by knowledge, decisional conflict, anxiety and post-decisional regret.

Public engagement in priority-setting: results from a pan-Canadian survey of decision-makers in cancer control.

Decision-makers are challenged to incorporate public input into priority-setting decisions. We conducted a pan-Canadian survey of decision-makers in cancer control to investigate the types of evidence, especially evidence supplied by the public, that are utilized in health care priority-setting. We further examined how normative attitudes and contextual factors influence the use of public engagement as evidence at the committee level. Administered between November and December 2012, 67 respondents from 117 invited individuals participated in the survey. The results indicated that public engagement was infrequently utilized compared to clinical effectiveness evidence or cost evidence. General positive agreement between normative attitudes towards the use of evidence and the frequency of evidence utilization was observed, but absence of correlative agreement was found for the types of evidence that are supplied by the general public and for cost-effectiveness inputs. Regression analyses suggested that public engagement was unevenly utilized between jurisdictions and that educational background and barriers to implementing public input may decrease the odds of using public engagement as evidence. We recommend that institutions establish a link between committee members' normative attitudes for using public engagement and its real-world utilization.