A Clinical Consensus Approach to Developing a New Funding Model for Radiation Services in Ontario.

In 2021, Ontario Health (Cancer Care Ontario) introduced a quality-based procedure model for the funding of radiation treatment (RT) in Ontario. This model ties reimbursement to patient care activities, ensuring equity and transparency in funding. Over 200 RT interprofessionals (oncologists, therapists and physicists) participated on 22 expert panels to establish or identify 288 evidence-based RT protocols and 672 quality expectations (QEs) to optimally deliver RT, which eventually led to the micro-costing of all protocols. Iterative review is required to ensure updated techniques and identify evolving standards of care, thereby providing the highest quality of RT care to Ontarians.

PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial.

BACKGROUND: Positron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer. METHODS: This pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6-10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained. DISCUSSION: This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective. TRIAL REGISTRATION: This trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.

Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews.

This review of reviews aimed to appraise the use of the CONSORT-PRO Extension as an evaluation tool for assessing the reporting of patient-reported outcome (PROs) in publications, and to describe the reporting of PRO research across reviews. We also outlined how variation in such evaluations impacts knowledge translation and may lead to potential misuse of the CONSORT-PRO Extension. We systematically searched Medline, Pubmed and CINAHL from 2013 to 2025 March 2021 for reviews of the completeness of reporting of PRO endpoints according to CONSORT-PRO criteria. Two reviewers extracted details of each review, the percentage of included studies that addressed each CONSORT-PRO item, and key recommendations from each review. Fourteen reviews met inclusion criteria, and only six of these used the full CONSORT-PRO checklist with minimal justified modifications. The remaining eight studies made significant or unjustified adjustments to the CONSORT-PRO Extension. Review studies also varied in how they scored multi-component CONSORT-PRO items. CONSORT-PRO items were often unreported in trial reports, and certain CONSORT-PRO items were reported less often than others. The reporting of statistical approaches to dealing with missing PRO data were poor in RCTs included in all 14 review articles. Studies reviewing PRO publications often omitted recommended CONSORT-PRO items from their evaluations, which may cause confusion among readers regarding how best to report their PRO research according to the CONSORT-PRO extension. Many trials published since CONSORT-PRO's release did not report recommended CONSORT-PRO items, which may lead to misinterpretation and consequently to research waste.

The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials.

BACKGROUND: The assessment of patient-reported outcomes in clinical trials has enormous potential to promote patient-centred care, but for this potential to be realized, the patient-reported outcomes must be captured effectively and communicated clearly. Over the past decade, methodologic tools have been developed to inform the design, analysis, reporting, and interpretation of patient-reported outcome data from clinical trials. We formed the PROTEUS-Trials Consortium (Patient-Reported Outcomes Tools: Engaging Users and Stakeholders) to disseminate and implement these methodologic tools. METHODS: PROTEUS-Trials are engaging with patient, clinician, research, and regulatory stakeholders from 27 organizations in the United States, Canada, Australia, the United Kingdom, and Europe to develop both organization-specific and cross-cutting strategies for implementing and disseminating the methodologic tools. Guided by the Knowledge-to-Action framework, we conducted consortium-wide webinars and meetings, as well as individual calls with participating organizations, to develop a workplan, which we are currently executing. RESULTS: Six methodologic tools serve as the foundation for PROTEUS-Trials dissemination and implementation efforts: the Standard Protocol Items: Recommendations for Interventional Trials-patient-reported outcome extension for writing protocols with patient-reported outcomes, the International Society for Quality of Life Research Minimum Standards for selecting a patient-reported outcome measure, Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium recommendations for patient-reported outcome data analysis, the Consolidated Standards for Reporting of Trials-patient-reported outcome extension for reporting clinical trials with patient-reported outcomes, recommendations for the graphic display of patient-reported outcome data, and a Clinician's Checklist for reading and using an article about patient-reported outcomes. The PROTEUS-Trials website (www.TheProteusConsortium.org) serves as a central repository for the methodologic tools and associated resources. To date, we have developed (1) a roadmap to visually display where each of the six methodologic tools applies along the clinical trial trajectory, (2) web tutorials that provide guidance on the methodologic tools at different levels of detail, (3) checklists to provide brief summaries of each tool's recommendations, (4) a handbook to provide a self-guided approach to learning about the tools and recommendations, and (5) publications that address key topics related to patient-reported outcomes in clinical trials. We are also conducting organization-specific activities, including meetings, presentations, workshops, and webinars to publicize the existence of the methodologic tools and the PROTEUS-Trials resources. Work to develop communications strategies to ensure that PROTEUS-Trials reach key audiences with relevant information about patient-reported outcomes in clinical trials and PROTEUS-Trials is ongoing. DISCUSSION: The PROTEUS-Trials Consortium aims to help researchers generate patient-reported outcome data from clinical trials to (1) enable investigators, regulators, and policy-makers to take the patient perspective into account when conducting research and making decisions; (2) help patients understand treatment options and make treatment decisions; and (3) inform clinicians' discussions with patients regarding treatment options. In these ways, the PROTEUS Consortium promotes patient-centred research and care.

Patient Engagement: an Assessment of Canadian Radiotherapy Programs' Current Practices, Perceived Barriers, and Facilitators.

Patient engagement and education have been mandated across Canadian radiation oncology programs (ROP). Guidance documents include the 2014 Canadian Association of Radiation Oncology (CARO) Radiation Therapy Patient Charter, the 2016 Canadian Partnership for Quality Radiotherapy (CPQR) Patient Engagement Guidelines (PEG) for Canadian Radiation Treatment Programs, and Accreditation Canada's 2017 refresh of Cancer Care Standards. Since little is known regarding uptake of these guidance statements, Canadian ROP were surveyed to assess current patient engagement and education practices. An e-survey was sent to Canadian ROP (n = 44). The survey focused on awareness and uptake of the CARO Patient Charter, CPQR PEG, and patient education practices. Survey development was guided by these documents and expert consensus, including CARO's Quality and Standards Patient Education/Engagement working group. Many (71%) responding ROP were familiar with the CARO Patient Charter, while 24% reported use. More than half (53%) of ROP were aware of the CPQR PEG, but approximately third (37%) had previously completed a self-audit. Most (88%) ROP view a pan-Canadian, evidence-based approach to educational materials beneficial and feasible (80%), with the majority (89%) willing to share their best practices across the radiotherapy community. Patient engagement and education are nationally mandated and supported by guidance documents. However, gaps have been identified across ROP for awareness and use of available tools, as well as uptake of their processes critical to quality of care. Understanding current practices will inform CPQR/CARO-supported pan-Canadian initiatives to optimize uptake, including development of CPQR Patient Education Guidance for Canadian Radiation Treatment Programs.

Mapping the Current State of Canadian Medical School Oncology Interest Groups.

Cancer is the leading cause of mortality in Canada. Undergraduate medical education therefore must ensure adequate oncology education for all physicians and inspire some to make oncology their career specialty, in an effort to ensure public care needs are met in the future. Medical student-led oncology interest groups (OIGs) are a subset of specialty interest groups that supplement formal didactic and clinical learning to increase exposure to oncology and access to mentors. We conducted a survey of OIG leaders to ascertain their goals, activities, barriers, future directions, and perceptions about employment prospects. OIG leaders from 12/17 Canadian medical schools responded. Medical oncology was the most represented specialty in OIGs. Half of OIGs had faculty mentors. Self-reported goals were to increase exposure to oncology disciplines (n = 12), assist students with career selection (n = 11) and finding mentors (n = 7), and enhance oncology education (n = 10). OIGs held on average 5 events per year (range 1-12). Reported barriers were finding time to plan events, declining student interest over academic year, and limited funding. Many OIGs showed interest in more standardized resources about oncology disciplines (n = 9), access to presentations (n = 10), more funding (n = 7), and collaboration (n = 7). Employment in many oncology specialties was perceived poorly, and the most important career selection considerations were ease of employment, practice location, and partner/family preference. Our survey highlights common goals, barriers, and perceptions in OIG medical student leaders across Canada and provides guidance for future interventions.

Online Improvement of Condition-Baesd Maintenance Policy via Monte Carlo Tree Search.

Often in manufacturing systems, scenarios arise where the demand for maintenance exceeds the capacity of maintenance resources. This results in the problem of allocating the limited resources among machines competing for them. This maintenance scheduling problem can be formulated as a Markov decision process (MDP) with the goal of finding the optimal dynamic maintenance action given the current system state. However, as the system becomes more complex, solving an MDP suffers from the curse of dimensionality. To overcome this issue, we propose a two-stage approach that first optimizes a static condition-based maintenance (CBM) policy using a genetic algorithm (GA) and then improves the policy online via Monte Carlo tree search (MCTS). The static policy significantly reduces the state space of the online problem by allowing us to ignore machines that are not sufficiently degraded. Furthermore, we formulate MCTS to seek a maintenance schedule that maximizes the long-term production volume of the system to reconcile the conflict between maintenance and production objectives. We demonstrate that the resulting online policy is an improvement over the static CBM policy found by GA. Note to Practitioners­: This article proposes a method of scheduling maintenance in complex manufacturing systems in scenarios where there is frequent competition for maintenance resources. We use a condition-based maintenance policy that prescribes maintenance actions based on a machine's current health. However, when several machines are due for maintenance, a maintenance technician must choose between multiple competing jobs. While a common approach is to establish rules that dictate how maintenance jobs should be prioritized, such as the first-in, first-out rule, the goal of this work is to improve upon static policies in real time. We do this by strategically evaluating sequences of maintenance actions and playing out many "what-if" scenarios to see how the system will behave in the future. Implementation of the proposed method relies on the construction of a simulation model of the target system. This model is capable of retrieving the current state of the physical system, including the degradation state of machines, the availability of maintenance resources, and the distribution of parts throughout buffers in the system. We present several simulation experiments that demonstrate the improvement in system performance that our approach provides. Future work will aim to improve the efficiency of maintenance prioritization through online learning as well as more accurately identify manufacturing system configurations that will yield the greatest benefit of these methods.

Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial.

BACKGROUND: Conventional external beam radiotherapy is the standard palliative treatment for spinal metastases; however, complete response rates for pain are as low as 10-20%. Stereotactic body radiotherapy delivers high-dose, ablative radiotherapy. We aimed to compare complete response rates for pain after stereotactic body radiotherapy or conventional external beam radiotherapy in patients with painful spinal metastasis. METHODS: This open-label, multicentre, randomised, controlled, phase 2/3 trial was done at 13 hospitals in Canada and five hospitals in Australia. Patients were eligible if they were aged 18 years and older, and had painful (defined as ≥2 points with the Brief Pain Inventory) MRI-confirmed spinal metastasis, no more than three consecutive vertebral segments to be included in the treatment volume, an Eastern Cooperative Oncology Group performance status of 0-2, a Spinal Instability Neoplasia Score of less than 12, and no neurologically symptomatic spinal cord or cauda equina compression. Patients were randomly assigned (1:1) with a web-based, computer-generated allocation sequence to receive either stereotactic body radiotherapy at a dose of 24 Gy in two daily fractions or conventional external beam radiotherapy at a dose of 20 Gy in five daily fractions using standard techniques. Treatment assignment was done centrally by use of a minimisation method to achieve balance for the stratification factors of radiosensitivity, the presence or absence of mass-type tumour (extraosseous or epidural disease extension, or both) on imaging, and centre. The primary endpoint was the proportion of patients with a complete response for pain at 3 months after radiotherapy. The primary endpoint was analysed in the intention-to-treat population and all safety and quality assurance analyses were done in the as-treated population (ie, all patients who received at least one fraction of radiotherapy). The trial is registered with ClinicalTrials.gov, NCT02512965. FINDINGS: Between Jan 4, 2016, and Sept 27, 2019, 229 patients were enrolled and randomly assigned to receive conventional external beam radiotherapy (n=115) or stereotactic body radiotherapy (n=114). All 229 patients were included in the intention-to-treat analysis. The median follow-up was 6·7 months (IQR 6·3-6·9). At 3 months, 40 (35%) of 114 patients in the stereotactic body radiotherapy group, and 16 (14%) of 115 patients in the conventional external beam radiotherapy group had a complete response for pain (risk ratio 1·33, 95% CI 1·14-1·55; p=0·0002). This significant difference was maintained in multivariable-adjusted analyses (odds ratio 3·47, 95% CI 1·77-6·80; p=0·0003). The most common grade 3-4 adverse event was grade 3 pain (five [4%] of 115 patients in the conventional external beam radiotherapy group vs five (5%) of 110 patients in the stereotactic body radiotherapy group). No treatment-related deaths were observed. INTERPRETATION: Stereotactic body radiotherapy at a dose of 24 Gy in two daily fractions was superior to conventional external beam radiotherapy at a dose of 20 Gy in five daily fractions in improving the complete response rate for pain. These results suggest that use of conformal, image-guided, stereotactically dose-escalated radiotherapy is appropriate in the palliative setting for symptom control for selected patients with painful spinal metastases, and an increased awareness of the need for specialised and multidisciplinary involvement in the delivery of end-of-life care is needed. FUNDING: Canadian Cancer Society and the Australian National Health and Medical Research Council.

Symptom Evolution in Patients with Esophageal and Gastric Cancer Receiving Palliative Chemotherapy: A Population-Based Study.

INTRODUCTION: Palliative chemotherapy (PC) is associated with a modest survival benefit in patients with incurable esophageal and gastric cancer; however, changes in symptom profile during treatment are not well described. Understanding the trajectory of symptoms during treatment may lead to improved care and facilitate shared decision making. In this study, we address this knowledge gap among all patients receiving PC in the Canadian province of Ontario. METHODS: Patients diagnosed with incurable esophageal and gastric cancer who received PC from 2012 to 2017 were identified from the Ontario Cancer Registry. Patients with one or more recorded Edmonton Symptom Assessment System (ESAS) scores in the 12 months following cancer diagnosis were included. The ESAS includes scores from 0 to 10 in nine domains (anxiety, depression, drowsiness, lack of appetite, nausea, pain, shortness of breath, tiredness, and lack of well-being). Symptom severity is categorized as none-mild (≤ 3), moderate (4-6), or severe (7-10). We focused on potentially modifiable symptoms, i.e. nausea, pain, and anxiety/depression. Logistic regression was used to identify factors associated with moderate-severe ESAS scores in these domains. Among those patients with serial ESAS scores (at 8 ± 2 and 12 ± 2 weeks) receiving chemotherapy, we describe changes during treatment (decrease by ≥ 1 = improved; - 1 > 0 > 1 = unchanged; increase by ≥ 1 = deteriorated). RESULTS: The cohort included 1900 patients who received PC, of whom 79% (1497/1900) had one or more recorded ESAS scores. In multivariate analysis, younger patients were more likely to have moderate-severe scores in nausea (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.23-2.90 [p < 0.01] in patients aged 41-50 years compared with patients aged ≥ 71 years) and pain (OR 1.88, 95% CI 1.36-2.60 [p < 0.01] in patients aged 51-60 years compared with patients aged ≥ 71 years). Compared with males, females were more likely to report moderate-severe scores in anxiety/depression (OR 1.58, 95% CI 1.21-2.08 [p < 0.01]). At 8 ± 2 weeks from PC initiation, symptom scores were unchanged in 19-42% of patients, improved in 30-51% of patients, and deteriorated in 17-35% of patients. The greatest change in symptom burden was observed for appetite (51% improvement) and anxiety/depression (35% deterioration). Similar trends were observed at 12 ± 2 weeks. CONCLUSIONS: In this large, population-based study, we observed that younger patients were more likely to report moderate-severe symptoms in pain and nausea, and females were more likely to report moderate-severe symptoms in anxiety/depression. Anxiety/depression symptoms become increasingly problematic for a substantial proportion of patients receiving PC. Supportive care efforts to mitigate these symptoms in routine practice are needed.

Coping during COVID-19: a mixed methods study of older cancer survivors.

PURPOSE: Older cancer survivors are among the most vulnerable to the negative effects of COVID-19 and may need specific survivorship supports that are unavailable/restricted during the pandemic. The objective of this study was to explore how older adults (≥ 60 years) who were recently (≤ 12 months) discharged from the care of their cancer team were coping during the pandemic. METHODS: We used a convergent mixed method design (QUAL+quan). Quantitative data were collected using the Brief-COPE questionnaire. Qualitative data were collected using telephone interviews to explore experiences and strategies for coping with cancer-related concerns. RESULTS: The mean sample age (n = 30) was 72.1 years (SD 5.8, range 63-83) of whom 57% identified as female. Participants' Brief-COPE responses indicated that they commonly used acceptance (n = 29, 96.7%), self-distraction (n = 28, 93.3%), and taking action (n = 28, 93.3%) coping strategies. Through our descriptive thematic analysis, we identified three themes: (1) drawing on lived experiences, (2) redeploying coping strategies, and (3) complications of cancer survivorship in a pandemic. Participants' coping strategies were rooted in experiences with cancer, other illnesses, life, and work. Using these strategies during the pandemic was not new-they were redeployed and repurposed-although using them during the pandemic was sometimes complicated. These data were converged to maximize interpretation of the findings. CONCLUSIONS: Study findings may inform the development or enhancement of cancer and non-cancer resources to support coping, particularly using remote delivery methods within and beyond the pandemic. Clinicians can engage a strengths-based approach to support older cancer survivors as they draw from their experiences, which contain a repository of potential coping skills.

Factors predicting missing instruments in three cancer randomized clinical trials.

PURPOSE: Missing patient-reported outcome (PRO) data can seriously threaten the validity of randomized clinical trials (RCTs). Identifying which factors predict missing instruments may help researchers develop strategies to prevent it from happening. This study examined the association of factors with time to the first missing instrument after randomization in three cooperative group RCTs. METHODS: We performed descriptive analyses and Cox proportional hazards regressions for three RCTs selected from the Canadian Cancer Trials Group: MA17 (breast cancer), PR7 (prostate cancer), and LY12 (non-Hodgkin's lymphoma). The outcome was the time from randomization to the first missing instrument. Variables for 15 factors were used as covariates based on availability and previously-reported putative associations with missing PRO data. RESULTS: Nine percent of 1352 subjects on MA17, 37% of 923 subjects on PR7, and 59% of 477 subjects on LY12 had a missing instrument. Twenty-five percent of subjects on MA17 had first missing instrument within 4.6 years. The median time to first missing instrument was: not observed for MA17, 7.3 years for PR7, 0.12 years for LY12. Cox regression revealed statistically significant independent associations with outcome for only five factors: baseline age (PR7) and level of well-being (LY12), and centre level of activity (LY12), presence of post-graduate residency training program (MA17, PR7), and centre geographic location (PR7, LY12). CONCLUSION: Many factors reported to have association with missing instruments do not seem to predict time to the first missing instrument after randomization in RCTs. Context is important in understanding the few that may.

International guidance on the selection of patient-reported outcome measures in clinical trials: a review.

PURPOSE: Patient-reported outcomes (PROs) are increasingly used in clinical trials to provide patients' perspectives regarding symptoms, health-related quality of life, and satisfaction with treatments. A range of guidance documents exist for the selection of patient-reported outcome measures (PROMs) in clinical trials, and it is unclear to what extent these documents present consistent recommendations. METHODS: We conducted a targeted review of publications and regulatory guidance documents that advise on the selection of PROMs for use in clinical trials. A total of seven guidance documents from the US Food and Drug Administration, European Medicines Agency, and scientific consortia from professional societies were included in the final review. Guidance documents were analyzed using a content analysis approach comparing them with minimum standards recommended by the International Society for Quality of Life Research. RESULTS: Overall there was substantial agreement between guidance regarding the appropriate considerations for PROM selection within a clinical trial. Variations among the guidance primarily related to differences in their format and differences in the perspectives and mandates of their respective organizations. Whereas scientific consortia tended to produce checklist or rating-type guidance, regulatory groups tended to use more narrative-based approaches sometimes supplemented with lists of criteria. CONCLUSION: The consistency in recommendations suggests an emerging consensus in the field and supports use of any of the major guidance documents available to guide PROM selection for clinical trials without concern of conflicting recommendations. This work represents an important first step in the international PROTEUS Consortium's ongoing efforts to optimize the use of PROs in clinical trials.

Access to radiotherapy among circumpolar Inuit populations.

Cancer is a substantial health burden for Inuit populations, an Indigenous peoples who primarily inhabit the circumpolar regions of Alaska, Canada, Greenland, and Russia. Access to radiotherapy is lacking or absent in many of these regions, despite it being an essential component of cancer treatment. This Review presents an overview of factors influencing radiotherapy delivery in each of the four circumpolar Inuit regions, which include population and geography, health-systems infrastructure, and cancer epidemiology. This Review also provides insight into the complex patient pathways needed to access radiotherapy, and on radiotherapy use. The unique challenges in delivering radiotherapy to circumpolar Inuit populations are discussed, which, notably, include geographical and cultural barriers. Recommendations include models of care that have successfully addressed these barriers, and highlight the need for increased collaboration between circumpolar referral centres in Alaska, Canada, Greenland, and Russia to ultimately allow for better delivery of cancer treatment.

A PRO-cision Medicine Methods Toolkit to Address the Challenges of Personalizing Cancer Care Using Patient-Reported Outcomes: Introduction to the Supplement.

Patients are increasingly being asked to complete standardized, validated questionnaires with regard to their symptoms, functioning, and well-being [ie, patient-reported outcomes (PROs)] as part of routine care. These PROs can be used to inform patients' care and management, which we refer to as "PRO-cision Medicine." For PRO-cision Medicine to be most effective, clinicians and patients need to be able to understand what the PRO scores mean and how to act on the PRO results. The papers in this supplement to Medical Care describe various methods that have been used to address these issues. Specifically, the supplement includes 14 papers: 6 describe different methods for interpreting PROs and 8 describe how different PRO systems have addressed interpreting PRO scores and/or acting on PRO results. As such, this "Methods Toolkit" can inform clinicians and researchers aiming to implement routine PRO reporting into clinical practice by providing methodological fundamentals and real-world examples to promote personalized patient care.

In proportion: approaches for displaying patient-reported outcome research study results as percentages responding to treatment.

PURPOSE: Patient-reported outcome (PRO) data from clinical trials can promote valuable patient-clinician communication and aid the decision-making process regarding treatment options. Despite these benefits, both patients and doctors face challenges in interpreting PRO scores. The purpose of this study was to identify best practices for presenting PRO results expressed as proportions of patients with changes from baseline (improved/stable/worsened) for use in patient educational materials and decision aids. METHODS: We electronically surveyed adult cancer patients/survivors, oncology clinicians, and PRO researchers, and conducted one-on-one cognitive interviews with patients/survivors and clinicians. Participants saw clinical trial data comparing two treatments as proportions changed using three different formats: pie charts, bar graphs, icon arrays. Interpretation accuracy, clarity, and format preference were analyzed quantitatively and online survey comments and interviews, qualitatively. RESULTS: The internet sample included 629 patients, 139 clinicians, and 249 researchers; 10 patients and 5 clinicians completed interviews. Bar graphs were less accurately interpreted than pie charts (OR 0.39; p < .0001) and icon arrays (OR 0.47; p < .0001). Bar graphs and icon arrays were less likely to be rated clear than pie charts (OR 0.37 and OR 0.18; both p < .0001). Qualitative data informed interpretation of these findings. CONCLUSIONS: For communicating PROs as proportions changed in patient educational materials and decision aids, these results support the use of pie charts.

Making a picture worth a thousand numbers: recommendations for graphically displaying patient-reported outcomes data.

PURPOSE: Patient-reported outcomes (PROs) can promote patient-centered care in multiple ways: (1) using an individual patient's PRO data to inform his/her management, (2) providing PRO results from comparative research studies in patient educational materials/decision aids, and (3) reporting PRO results from comparative research studies in peer-reviewed publications. Patients and clinicians endorse the value of PRO data; however, variations in how PRO measures are scored and scaled, and in how the data are reported, make interpretation challenging and limit their use in clinical practice. We conducted a modified Delphi process to develop stakeholder-engaged, evidence-based recommendations for PRO data display for the three above applications to promote understanding and use. METHODS: The Consensus Panel included cancer survivors/caregivers, oncologists, PRO researchers, and application-specific end-users (e.g., electronic health record vendors, decision aid developers, journal editors). We reviewed the data display issues and their evidence base during pre-meeting webinars. We then surveyed participants' initial perspectives, which informed discussions during an in-person meeting to develop consensus statements. These statements were ratified via a post-meeting survey. RESULTS: Issues addressed by consensus statements relevant to both individual and research data applications were directionality (whether higher scores are better/worse) and conveying score meaning (e.g., none/mild/moderate/severe). Issues specific to individual patient data presentation included representation (bar charts vs. line graphs) and highlighting possibly concerning scores (absolute and change). Issues specific to research study results presentation included handling normed data, conveying statistically significant differences, illustrating clinically important differences, and displaying proportions improved/stable/worsened. CONCLUSIONS: The recommendations aim to optimize accurate and meaningful interpretation of PRO data.

Health-Related Internet Use Among Men With Prostate Cancer in Canada: Cancer Registry Survey Study.

BACKGROUND: After a prostate cancer diagnosis, men want information about their disease and treatment options. The internet offers a convenient means to deliver health information to patients with prostate cancer. However, there are concerns about the use of the internet among this largely senior population. OBJECTIVE: This study aimed to determine the patterns and factors associated with the use of the internet as a source of health information among Canadian men with prostate cancer and the features and information required in a website. METHODS: Population surveys were conducted in four Canadian provinces (British Columbia, Alberta, Saskatchewan, and Ontario) in 2014-2015. Data analyses included descriptive, bivariable, and multivariable analyses. The Pearson Chi-square and univariable regression were used to examine associations between independent variables and health-related internet use. Correlates of health-related internet use were analyzed using multivariable logistic regression. RESULTS: A total of 1362 patients responded across the four provinces. The mean age of respondents was 69 years (SD 8.2). In addition, 82% (n=1071) were internet users and 71% (n=910) used the internet daily. Further, 65% (n=784) used the internet as a source of prostate cancer information, and 40% (n=521) were confident about using information obtained from the internet to make health decisions. Men who used the internet to obtain prostate cancer information were more likely to be active information seekers (odds ratio [OR]: 4.5, 95% CI 2.6-7.8), be confident using information from the internet to make health decisions (OR: 3.6, 95% CI 2.3-5.7), have broadband internet access (OR: 1.8, 95% CI 1.2-2.7), and have more unmet supportive care needs (OR: 1.05, 95% CI 1.0-1.1). Top features wanted in a website, reported by more than 50% of respondents, were a library of resources (n=893, 65.6%), tools to support treatment decision making (n=815, 59.8%), and tools to help navigate the prostate cancer journey (n=698, 51.2%). Top three topics of information wanted in such a website were treatment options (n=916, 67.3%), disease progression (n=904, 66.4%), and management of side effects (n=858, 63%). CONCLUSIONS: Over two-thirds of Canadian patients with prostate cancer surveyed use the internet as a source of health information about prostate cancer, but over half did not feel confident using information from the internet to make health decisions. Being an active information seeker, having confidence in using information from the internet to make health decisions, having broadband internet, and having more unmet supportive care needs were significantly associated with health-related internet use. Future work should examine electronic health literacy interventions as a means to boost men's confidence in using information from the internet and design websites that include information and features that help men navigate the prostate cancer journey and support treatment decision making and management of side effects.

Quality of life as a prognostic indicator of survival: A pooled analysis of individual patient data from canadian cancer trials group clinical trials.

BACKGROUND: The aims of this study were to externally validate an established association between baseline health-related quality of life (HRQOL) scores and survival and to assess the added prognostic value of HRQOL with respect to demographic and clinical indicators. METHODS: Pooled data were analyzed from 17 randomized controlled trials opened by the Canadian Cancer Trials Group between 1991 and 2004; they included survival and baseline HRQOL data from 3606 patients with 8 different cancer sites. The models included sex, age (≤60 vs >60 years), World Health Organization performance status (0 or 1 vs 2-4), distant metastases (no vs yes), and 15 European Organization for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire (QLQ-C30) scales. Analyses were conducted with multivariate Cox proportional hazards models and were stratified by cancer site. Harrell's discrimination C-index was used to calculate the predictive accuracy of the model when HRQOL parameters were added to clinical and demographic variables. The added value of adding HRQOL scales to clinical and demographic variables was illustrated with Kaplan-Meier curves. RESULTS: In the stratified, multivariate model, HRQOL parameters-global health status (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.95-1.00; P < . 0001), dyspnea (HR, 1.04; 95% CI, 1.02-1.06; P < . 0002), and appetite loss (HR, 1.06; 95% CI, 1.04-1.08; P < . 0001)-were independent prognostic factors in addition to the demographic and clinical variables (all P values < .05). Adding these HRQOL variables to the clinical variables resulted in an added relative prognostic value for survival of 5%. CONCLUSIONS: These results confirm previous findings showing that baseline HRQOL scores on the EORTC QLQ-C30 provide prognostic information in addition to information from clinical measures. However, the impact of specific domains may differ across studies. Cancer 2018. © 2018 American Cancer Society.

Presenting comparative study PRO results to clinicians and researchers: beyond the eye of the beholder.

PURPOSE: Patient-reported outcome (PRO) results from clinical trials can inform clinical care, but PRO interpretation is challenging. We evaluated the interpretation accuracy and perceived clarity of various strategies for displaying clinical trial PRO findings. METHODS: We conducted an e-survey of oncology clinicians and PRO researchers (supplemented by one-on-one clinician interviews) that randomized respondents to view one of the three line-graph formats (average scores over time for two treatments on four domains): (1) higher scores consistently indicating "better" patient status; (2) higher scores indicating "more" of what was being measured (better for function, worse for symptoms); or (3) normed scores. Two formats displayed proportions changed (pie/bar charts). Multivariate modeling was used to analyze interpretation accuracy and clarity ratings. RESULTS: Two hundred and thirty-three clinicians and 248 researchers responded; ten clinicians were interviewed. Line graphs with "better" directionality were more likely to be interpreted accurately than "normed" line graphs (OR 1.55; 95% CI 1.01-2.38; p = 0.04). No significant differences were found between "better" and "more" formats. "Better" formatted graphs were also more likely to be rated "very clear" versus "normed" formatted graphs (OR 1.91; 95% CI 1.44-2.54; p < 0.001). For proportions changed, respondents were less likely to make an interpretation error with pie versus bar charts (OR 0.35; 95% CI 0.2-0.6; p < 0.001); clarity ratings did not differ between formats. Qualitative findings informed the interpretation of the survey findings. CONCLUSIONS: Graphic formats for presenting PRO data differ in how accurately they are interpreted and how clear they are perceived to be. These findings will inform the development of best practices for optimally reporting PRO findings.

Minimal clinically important differences in the EORTC QLQ-C30 and brief pain inventory in patients undergoing re-irradiation for painful bone metastases.

PURPOSE: The EORTC QLQ-C30 and the Brief Pain Inventory (BPI) are validated tools for measuring quality of life (QOL) and the impact of pain in patients with advanced cancer. Interpretation of these instrument scores can be challenging and it is difficult to know what numerical changes translate to clinically significant impact in patients' lives. To address this issue, our study sought to establish the minimal clinically important differences (MCID) for these two instruments in a prospective cohort of patients with advanced cancer and painful bone metastases. METHODS: Both anchor-based and distribution-based methods were used to estimate the MCID scores from patients enrolled in a randomized phase III trial evaluating two different re-irradiation treatment schedules. For the anchor-based method, the global QOL item from the QLQ-C30 was chosen as the anchor. Spearman correlation coefficients were calculated for all items and only those items with moderate or better correlation (|r| ≥ 0.30) with the anchor were used for subsequent analysis. A 10-point difference in the global QOL score was used to classify improvement and deterioration, and the MCID scores were calculated for each of these categories. These results were compared with scores obtained by the distribution-method, which estimates the MCID purely from the statistical characteristics of the sample population. RESULTS: A total of 375 patients were included in this study with documented pain responses and completed QOL questionnaires at 2 months. 9/14 items in the QLQ-C30 and 6/10 items in the BPI were found to have moderate or better correlation with the anchor. For deterioration, statistically significant MCID scores were found in all items of the QLQ-C30 and BPI. For improvement, statistically significant MCID scores were found in 7/9 items of the QLQ-C30 and 2/6 items of the BPI. The MCID scores for deterioration were uniformly higher than the MCIDs for improvement. Using the distribution-based method, there was good agreement between the 0.5 standard deviation (SD) values and anchor-based scores for deterioration. For improvement, there was less agreement and the anchor-based scores were lower than the 0.5 SD values obtained from the distribution-based method. CONCLUSION: We present MCID scores for the QLQ-C30 and BPI instruments obtained from a large cohort of patients with advanced cancer undergoing re-irradiation for painful bone metastases. The results from this study were compared to other similar studies which showed larger MCID scores for improvement compared to deterioration. We hypothesize that disease trajectory and patient expectations are important factors in understanding the contrasting results. The results of this study can guide clinicians and researchers in the interpretation of these instruments.