What do these scores mean? Presenting patient-reported outcomes data to patients and clinicians to improve interpretability.

BACKGROUND: Patient-reported outcomes (PROs) (eg, symptoms, functioning) can inform patient management. However, patients and clinicians often have difficulty interpreting score meaning. The authors tested approaches for presenting PRO data to improve interpretability. METHODS: This mixed-methods study included an Internet survey of cancer patients/survivors, oncology clinicians, and PRO researchers circulated via snowball sampling, plus individual in-person interviews. Clinical importance was conveyed using 3 approaches (presented in random order): normal score range shaded green, concerning scores circled in red, and red threshold lines indicating normal versus concerning scores. Versions also tested 2 approaches to score directionality: higher = more (better for function, worse for symptoms) and higher = better for both function and symptoms. Qualitative data from online comments and in-person interviews supplemented quantitative results on interpretation accuracy, clarity, and the "most useful" format. RESULTS: The survey included 1113 respondents: 627 survivors, 236 clinicians, and 250 researchers, plus 10 patients and 10 clinicians who were purposively sampled interviewees. Interpretation accuracy ranged from 53% to 100%. The formats in which higher = better were interpreted more accurately versus those in which higher = more (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.07-1.58) and were more likely to be rated "very"/"somewhat" clear (OR, 1.39; 95% CI, 1.13-1.70) and "very" clear (OR, 1.36; 95% CI, 1.18-1.58). Red circle formats were interpreted more accurately than green-shaded formats when the first format presented (OR, 1.29; 95% CI, 1.00-1.65). Threshold-line formats were more likely to be rated "very" clear than green-shaded (OR, 1.43; 95% CI, 1.19-1.71) and red-circled (OR, 1.22, 95% CI, 1.02-1.46) formats. Threshold lines were most often selected as "most useful." CONCLUSIONS: The current results support presenting PRO data with higher = better directionality and threshold lines indicating normal versus concerning scores. Cancer 2017;123:1848-1859. © 2017 The Authors. Cancer published byWiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations aremade.

Quality of life with cediranib in relapsed ovarian cancer: The ICON6 phase 3 randomized clinical trial.

BACKGROUND: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment. METHODS: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group. RESULTS: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea. CONCLUSIONS: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Engaging stakeholders to improve presentation of patient-reported outcomes data in clinical practice.

PURPOSE: Patient-reported outcomes (PROs) can promote patient-centered care, but previous research has documented interpretation challenges among clinicians and patients. We engaged stakeholders to improve formats for presenting individual-level PRO data (for patient monitoring) and group-level PRO data (for reporting comparative clinical studies). METHODS: In an iterative process, investigators partnered with stakeholder workgroups of clinicians and patients to address previously identified interpretation challenges. Candidate approaches were then tested in semi-structured, one-on-one interviews with cancer patients and clinicians. Interpretation issues addressed included conveying score meaning (i.e., what is good/bad) and directional inconsistency (whether higher scores are better/worse). An additional issue for individual-level PROs was highlighting potentially concerning scores and, for group-level PROs, identifying important between-group differences (clinical, statistical). RESULTS: One-on-one interviews in a purposive sample of clinicians (n = 40) and patients (n = 39) provided insights regarding approaches to address issues identified. For example, adding descriptive labels to the Y-axis (none, mild, moderate, severe) helps address directional inconsistency and aids interpretation of score meaning. Red circles around concerning data points or a threshold line indicating worse-than-normal scores indicate possibly concerning scores for individual-level PRO data. For group-level PRO data, patients and some clinicians are confused by confidence limits and clinical versus statistical significance, but almost all clinicians want p values displayed. CONCLUSIONS: Variations in interpretation accuracy demonstrate the importance of presenting PRO data in ways that promote understanding and use. In an iterative stakeholder-driven process, we developed improved PRO data presentation formats, which will be evaluated in further research across a large population of patients and clinicians.

Communicating patient-reported outcome scores using graphic formats: results from a mixed-methods evaluation.

BACKGROUND: Patient-reported outcomes (PROs) promote patient-centered care by using PRO research results ("group-level data") to inform decision making and by monitoring individual patient's PROs ("individual-level data") to inform care. We investigated the interpretability of current PRO data presentation formats. METHOD: This cross-sectional mixed-methods study randomized purposively sampled cancer patients and clinicians to evaluate six group-data or four individual-data formats. A self-directed exercise assessed participants' interpretation accuracy and ratings of ease-of-understanding and usefulness (0 = least to 10 = most) of each format. Semi-structured qualitative interviews explored helpful and confusing format attributes. RESULTS: We reached thematic saturation with 50 patients (44 % < college graduate) and 20 clinicians. For group-level data, patients rated simple line graphs highest for ease-of-understanding and usefulness (median 8.0; 33 % selected for easiest to understand/most useful) and clinicians rated simple line graphs highest for ease-of-understanding and usefulness (median 9.0, 8.5) but most often selected line graphs with confidence limits or norms (30 % for each format for easiest to understand/most useful). Qualitative results support that clinicians value confidence intervals, norms, and p values, but patients find them confusing. For individual-level data, both patients and clinicians rated line graphs highest for ease-of-understanding (median 8.0 patients, 8.5 clinicians) and usefulness (median 8.0, 9.0) and selected them as easiest to understand (50, 70 %) and most useful (62, 80 %). The qualitative interviews supported highlighting scores requiring clinical attention and providing reference values. CONCLUSIONS: This study has identified preferences and opportunities for improving on current formats for PRO presentation and will inform development of best practices for PRO presentation. Both patients and clinicians prefer line graphs across group-level data and individual-level data formats, but clinicians prefer greater detail (e.g., statistical details) for group-level data.

Integrating health-related quality of life findings from randomized clinical trials into practice: an international study of oncologists' perspectives.

PURPOSE: Although health-related quality of life (HRQL) is increasingly assessed in randomized controlled trials (RCTs), HRQL findings are not always incorporated into clinical decision making. We examined the current perspectives of oncologists on the use of HRQL findings from RCTs, and variation of these perspectives between countries and specialties. METHODS: A cross-sectional e-survey of oncologist members of the NCIC Clinical Trials Group, the United Kingdom National Cancer Research Institute Clinical Studies Groups, and the Australia/New Zealand cancer clinical trials network was conducted. Respondents reported their perceptions of the usefulness of RCT HRQL outcomes for informing practice, their use of HRQL findings in practice, barriers/facilitators to this use, and preferences for HRQL data presentation in RCT publications. Chi-square tests compared responses between countries and specialties. RESULTS: A total of 396 oncologists participated (estimated response rate: 30%). The most frequently reported specialties were medical (46%) and radiation (37%) oncology. HRQL findings from RCTs were reported as useful (73%), but were infrequently used to guide clinical decisions with patients. Perceived barriers were lack of time (67%) and understanding (57%), and concerns about generalizability of results (68%). Identified facilitators included joint publication of HRQL/clinical outcomes (96%) and summary of clinical implications of HRQL findings in RCT publications (76%). Use of HRQL findings, perceived barriers/facilitators, and presentation preferences did not differ by country or specialty. CONCLUSIONS: Oncologists support HRQL findings from RCTs, but perceive important barriers to their use in clinical decision making, regardless of country or specialty. Combined, clear reporting of HRQL/clinical data may facilitate their clinical application.

Single versus multiple fractions of repeat radiation for painful bone metastases: a randomised, controlled, non-inferiority trial.

BACKGROUND: Although repeat radiation treatment has been shown to palliate pain in patients with bone metastases from multiple primary origin sites, data for the best possible dose fractionation schedules are lacking. We aimed to assess two dose fractionation schedules in patients with painful bone metastases needing repeat radiation therapy. METHODS: We did a multicentre, non-blinded, randomised, controlled trial in nine countries worldwide. We enrolled patients 18 years or older who had radiologically confirmed, painful (ie, pain measured as ≥2 points using the Brief Pain Inventory) bone metastases, had received previous radiation therapy, and were taking a stable dose and schedule of pain-relieving drugs (if prescribed). Patients were randomly assigned (1:1) to receive either 8 Gy in a single fraction or 20 Gy in multiple fractions by a central computer-generated allocation sequence using dynamic minimisation to conceal assignment, stratified by previous radiation fraction schedule, response to initial radiation, and treatment centre. Patients, caregivers, and investigators were not masked to treatment allocation. The primary endpoint was overall pain response at 2 months, which was defined as the sum of complete and partial pain responses to treatment, assessed using both Brief Pain Inventory scores and changes in analgesic consumption. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00080912. FINDINGS: Between Jan 7, 2004, and May 24, 2012, we randomly assigned 425 patients to each treatment group. 19 (4%) patients in the 8 Gy group and 12 (3%) in the 20 Gy group were found to be ineligible after randomisation, and 140 (33%) and 132 (31%) patients, respectively, were not assessable at 2 months and were counted as missing data in the intention-to-treat analysis. In the intention-to-treat population, 118 (28%) patients allocated to 8 Gy treatment and 135 (32%) allocated to 20 Gy treatment had an overall pain response to treatment (p=0·21; response difference of 4·00% [upper limit of the 95% CI 9·2, less than the prespecified non-inferiority margin of 10%]). In the per-protocol population, 116 (45%) of 258 patients and 134 (51%) of 263 patients, respectively, had an overall pain response to treatment (p=0·17; response difference 6·00% [upper limit of the 95% CI 13·2, greater than the prespecified non-inferiority margin of 10%]). The most frequently reported acute radiation-related toxicities at 14 days were lack of appetite (201 [56%] of 358 assessable patients who received 8 Gy vs 229 [66%] of 349 assessable patients who received 20 Gy; p=0·011) and diarrhoea (81 [23%] of 357 vs 108 [31%] of 349; p=0·018). Pathological fractures occurred in 30 (7%) of 425 patients assigned to 8 Gy and 20 (5%) of 425 assigned to 20 Gy (odds ratio [OR] 1·54, 95% CI 0·85-2·75; p=0·15), and spinal cord or cauda equina compressions were reported in seven (2%) of 425 versus two (<1%) of 425, respectively (OR 3·54, 95% CI 0·73-17·15; p=0·094). INTERPRETATION: In patients with painful bone metastases requiring repeat radiation therapy, treatment with 8 Gy in a single fraction seems to be non-inferior and less toxic than 20 Gy in multiple fractions; however, as findings were not robust in a per-protocol analysis, trade-offs between efficacy and toxicity might exist. FUNDING: Canadian Cancer Society Research Institute, US National Cancer Institute, Cancer Council Australia, Royal Adelaide Hospital, Dutch Cancer Society, and Assistance Publique-Hôpitaux de Paris.

Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.

The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized controlled trials (RCTs); however, it lacks guidance on the reporting of patient-reported outcomes (PROs), which are often inadequately reported in trials, thus limiting the value of these data. In this article, we describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points. These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract, that a description of the hypothesis of the PROs and relevant domains be provided (ie, if a multidimensional PRO tool has been used), that evidence of the PRO instrument's validity and reliability be provided or cited, that the statistical approaches for dealing with missing data be explicitly stated, and that PRO-specific limitations of study findings and generalizability of results to other populations and clinical practice be discussed. Examples and an updated CONSORT flow diagram with PRO items are provided. It is recommended that the CONSORT PRO guidance supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes. Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care.

Patients' attitudes and preferences toward delayed disease progression in the absence of improved survival.

BACKGROUND: Cancer patients' attitudes toward progression-free survival (PFS) gains offered by treatment are not well understood, particularly in the absence of overall survival (OS) gains. The objectives were to describe patients' willingness to accept treatment that offers PFS gains without OS gains, to compare these findings with treatments offering OS gains, and to qualitatively summarize patients' reasons for their preferences. METHODS: A multicenter, cross-sectional, convergent mixed-methods study design recruited patients who had received at least 3 months of systemic therapy for incurable solid tumors. A treatment trade-off exercise determined the gains in imaging PFS that patients require to prefer additional systemic treatment for a scenario of a newly diagnosed, asymptomatic, incurable abdominal tumor. A qualitative, descriptive, thematic analysis explored factors influencing patients' decisions, and a narrative method integrated the quantitative and qualitative findings. RESULTS: In total, 100 patients participated (63% were older than 60 years of age). If additional treatment with added toxicity offered no OS advantage, 17% would prefer it for no PFS benefit; 26% for some PFS benefit (range, 3-9 months), whereas 51% would decline it regardless of PFS benefit. Similarly, 71% preferred additional treatment offering a 6-month OS advantage dependent on described toxicity levels (P = .03). A spectrum of reasons for these preferences reflected the complexity of participants' attitudes and values. CONCLUSIONS: Prolongation of time to progression was not universally valued. Most patients did not prefer treatments that negatively affect quality of life for PFS gains alone. Implications for individual decision making, policy, and trials research are discussed.

Listening to the Patient Voice Adds Value to Cancer Clinical Trials.

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials.

Assessing the impact of comorbid illnesses on death within 10 years in prostate cancer treatment candidates.

BACKGROUND: Treatment choice in prostate cancer is influenced by pre-existing comorbid illnesses, but information about their individual prognostic impact is sparse, and only 1 comorbidity index has been developed for this setting. The authors assessed the impact of individual comorbid illnesses on the risk of early, other-cause death in prostate cancer treatment candidates and propose a modification of an existing comorbidity scale. METHODS: A population-based case-cohort study included patients diagnosed from 1990 through 1998 in Ontario, Canada who had planned curative radiotherapy or prostatectomy. The subcohort numbered 1643, and the case sample (those dying of other causes within 10 years) numbered 630. Ontario Cancer Registry data were linked to data from medical charts, including: age, comorbidity using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G), stage, prostate-specific antigen, Gleason score, and treatment. Cox proportional hazards regression assessed the age-adjusted association between CIRS-G and other-cause death. RESULTS: Respiratory and cardiac diseases were the most common comorbidities and most strongly associated with an increased risk of death. Other important comorbidities included vascular disease, renal disease, and diabetes. The modified CIRS-G(pros) score yielded a relative risk (RR) of 1.64 (95% confidence interval [CI], 1.52-1.76) for those scoring 1 compared with 0 and RR 1.18 (95% CI, 1.15-1.21) for each increment above 1. Except for those aged >80 years, results were consistent across treatment type and age group. CONCLUSIONS: This study provides estimates of the role of individual comorbid illnesses in prostate cancer. The modified CIRS-G(pros) could be useful in the clinic and in future research on this patient population.

Information that affects patients' treatment choices for early stage prostate cancer: a review.

INTRODUCTION: We conducted a systematic review of primary evidence to clarify what information influences treatment selection by patients with early stage prostate cancer. MATERIALS AND METHODS: We conducted a systematic review of the Web of Knowledge, using the ALL DATABASES option. Papers were then triaged out on the basis of the title and/or abstract, leaving 120 papers. Reviewing the full papers resulted in a final corpus of 21 papers. RESULTS: The data suggest that patients typically balance potential benefits against potential side effects but in a complex way with large variation across patients. For some patients, potential benefits relate to chances of survival but, for others, relate to control over cancer spread. The most common potential harm is effect on bladder functioning but even that is not a concern of all patients. Similarly, potential impact on bowel and on sexual functioning affects some patients' decisions but not others. Patient decisions are also affected by information not typically identified as affecting this decision. These include aspects of treatment and decision processes, competencies, and others' opinions, again, with wide variation across patients. The patient's view of which information items affect his decision may also change over time, consistent with a dynamic decision-making process. CONCLUSIONS: Decision support interventions are needed to optimally tailor information for decision-making to the individual patient, and should be designed to accommodate the illustrated variation in patients' needs.

Clinical research associates experience with missing patient reported outcomes data in cancer randomized controlled trials.

BACKGROUND: Missing patient reported outcomes data threaten the validity of PRO-specific findings and conclusions from randomized controlled trials by introducing bias due to data missing not at random. Clinical Research Associates are a largely unexplored source for informing understanding of potential causes of missing PRO data. The purpose of this qualitative research was to describe factors that influence missing PRO data, as revealed through the lived experience of CRAs. METHODS: Maximum variation sampling was used to select CRAs having a range of experiences with missing PRO data from academic or nonacademic centers in different geographic locations of Canada. Semistructured interviews were audio-recorded, transcribed verbatim, and analyzed according to descriptive phenomenology. RESULTS: Eleven CRAs were interviewed. Analysis revealed several factors that influence missing PRO data that were organized within themes. PROs for routine clinical care compete with PROs for RCTs. Both the paper and electronic formats have benefits and drawbacks. Missing PRO data are influenced by characteristics of the instruments and of the patients. Assessment of PROs at progression of disease is particularly difficult. Deficiencies in center research infrastructure can contribute. CRAs develop relationships with patients that may help reduce missing PRO data. It is not always possible to provide sufficient time to complete the instrument. There is a need for field guidance and a motivation among CRAs to contribute their knowledge to address issues. CONCLUSION: These results enhance understanding of factors influencing missing PRO data and have important implications for designing operational solutions to improve data quality on cancer RCTs.

Application of Value Frameworks to the Design of Clinical Trials: The Canadian Cancer Trials Group Experience.

BACKGROUND: Use of value framework thresholds in the design of clinical trials may increase the proportion of randomized controlled trials that identify clinically meaningful advances for patients. Existing frameworks have not been applied to the research output of a cooperative cancer trials group. We apply value frameworks to the randomized controlled trial output of the Canadian Cancer Trials Group (CCTG). METHODS: Statistical design, study characteristics, and results of all published phase III trials of CCTG were abstracted. We applied the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and American Society of Clinical Oncology Net Health Benefit to study results and the statistical power calculations to identify the proportion of all trials that were designed to detect a substantial clinical benefit. RESULTS: During 1979 to 2017, CCTG published 113 phase III trials; 52.2% (59 of 113) of these trials were positive. One-half (50.4%, 57 of 113) of the trials were conducted in the palliative setting. In 37.2% (42 of 113) of trials, the primary endpoint was overall survival; disease-free survival or progression-free survival was used in 38.9% (44 of 113) of trials. The ESMO-MCBS could be applied to the power calculation for 69 trials; 73.9% (51 of 69) of these trials were designed to detect an effect size that could meet ESMO-MCBS thresholds for substantial benefit. Among the 51 positive trials for which the ESMO-MCBS could be applied, 41.1% (21 of 51) met thresholds for substantial benefit. CONCLUSIONS: Most CCTG phase III trials were designed to detect clinically meaningful differences in outcome, although less than one-half of positive trials met the threshold for substantial benefit. Application of value frameworks to the design of clinical trials is practical and may improve research efficiency and treatment options for patients.

How do interventions designed to improve provider-patient communication work? Illustrative applications of a framework for communication.

In this broad overview for the Conference: "State of the Science in Cancer Care", we review a conceptual framework of physician-patient communication and use the framework to inform the application of theory regarding communication and patient preferences in clinical practice. Using a selection of research, we illustrate how problematic issues in communication can be represented by the framework. We further illustrate how interventions designed to improve communication or to elicit patients' preferences in a medical encounter may have their desired effect, or may be optimally evaluated.

Promoting effective use of patient-reported outcomes in clinical practice: themes from a "Methods Tool kit" paper series.

OBJECTIVES: "PRO-cision Medicine," using patients' reports of their symptoms, functioning, and well-being to personalize their care, is becoming more prevalent. Patient-reported outcomes (PROs) are assessed using standardized, validated measures. Research shows that clinicians' and patients' understanding of what the PRO scores mean and how to act on them is often suboptimal. Methods to improve interpretation of PRO scores and action based on PRO results can promote more effective use of PROs in practice. STUDY DESIGN AND SETTING: A recent supplement to Medical Care describes various approaches to address challenges in interpreting and acting on PROs in practice and therefore serves as a "PRO-cision Medicine Methods Tool kit." This commentary provides an overview of the supplement and identifies cross-cutting themes guided by a theoretical framework. RESULTS: Six papers describe methods for interpreting PROs, and eight papers describe how different PRO systems address interpreting PRO scores and/or acting on PRO results. Based on the theoretical framework, cross-cutting themes are described in terms of (1) providing PRO information, (2) using PRO data, (3) screening for problems and monitoring for changes, and (4) changing management and behavior. CONCLUSIONS: The PRO-cision Medicine Methods Tool kit provides a useful resource for interpreting and acting on PRO scores to personalize patient care.

Androgen deprivation therapy for prostate cancer and the risk of bladder cancer: A systematic review of observational studies.

BACKGROUND: Recent interest has been geared towards the potential therapeutic and chemopreventive benefit of androgen deprivation therapy (ADT) for bladder cancer. As a result, several observational studies have investigated this potential association. Given the important side effects associated with ADT treatment, understanding the methodological strengths and weaknesses of the current evidence is warranted. OBJECTIVES: The objective of this systematic review was to examine the heterogeneity of the current observational studies on the association between ADT and bladder cancer by assessing the methodological strengths and limitations of these studies. MATERIAL AND METHODS: We systematically searched Medline, EMBASE, Healthstar, Cochrane Library Online, Science Citation Index, and Dissertation Abstracts Online, from inception to August 2019 to identify all observational studies investigating the association between ADT and bladder cancer. We assessed overall study quality using the ROBINS-I tool and evaluated the presence of other key pharmacoepidemiologic biases. RESULTS: Overall, our systematic review included 7 observational studies. Five studies reported a decreased risk of bladder cancer with ADT use, 1 study reported no association, and 1 study reported an increased risk. All studies had time-related biases, did not consider a lag period, and had potential residual confounding. Moreover, 1 study had potential detection bias, 6 included prevalent users, 3 had inadequate follow-up durations, 6 had exposure misclassification, and 5 used an inappropriate comparator. CONCLUSION: Taken together, future methodologically-rigorous studies addressing the limitations underlined in this systematic review are needed to evaluate the important potential association between ADT and bladder cancer.

Overall information needs of early-stage prostate cancer patients over a decade: highly variable and remarkably stable.

PURPOSE: To assess the stability of information needs of early-stage prostate cancer patients by comparing needs in the same location, at two time points, almost 10 years apart. METHOD: Two groups of patients were surveyed (first, 1996; second, 2005) to identify retrospectively their information needs in the diagnosis-to-treatment-decision time interval. Both sampling cohorts were men diagnosed in one location in Canada within the previous 2 years. Participants rated the importance of getting answers to each of 92 questions (organized in eight categories) using four options: essential, desired, no opinion, or avoid. For each essential and desired question, respondents also indicated the reason(s) they wanted the question addressed: to understand, decide, plan, or other. RESULTS: The two groups had similar response rates: 38 (68%) in 1996 and 130 (70%) in 2005. They also had similar ages, marital status, or education. Both groups rated means of: 49 questions "essential" with wide ranges across respondents (12-90 vs 0-92 questions); 73 questions as "essential"/"desired"; and two questions to "avoid". At both times, every question was essential to some participants but only six (in 1996) and 12 (in 2005) questions were essential to over 80% of participants. In both groups, the most frequent reason for essential questions was for understanding (mean number of questions 34 vs 36), followed by decision making (means 13 vs 19), and then planning (means 10 vs 15). CONCLUSIONS: We have demonstrated reliably that, although many patients want a lot of information, the range in amount and in exact details varies considerably across individuals. Systematic patient education is needed, therefore, but it must be individualized.

Medical oncology job satisfaction: Results of a global survey.

BACKGROUND: While physician burnout is increasingly recognized, little is known about medical oncologist job satisfaction, and the factors associated with low satisfaction. Here, we report the results of an international survey of medical oncologists. METHODS: An online survey was distributed using a modified snowball methodology via national oncology societies to chemotherapy-prescribing physicians in 65 countries. Oncologist job satisfaction was assessed by asking, "On a scale of 1-10, how would you rate your satisfaction as an oncologist? 1 = unsatisfying, 10 = satisfying." Low, moderate and high job satisfaction was defined as scores of 1-6, 7-8, and 9-10, respectively. RESULTS: 1,115 physicians from 42 countries completed the survey. Overall job satisfaction rates were 20% (222/1,115), 51% (573/1,115), and 29% (320/1,115) for low-, moderate-, and high-satisfaction, respectively. Respondents with low job satisfaction were younger (P = 0.001) and had fewer years in clinical practice (P = 0.013) compared to those with high satisfaction. Increasing hours worked by per week (p = 0.042), decreasing annual weeks of paid vacation (P = 0.007), being on-call every night (P = 0.016), higher clinic volumes (P = 0.004) and lack of access to on-site radiotherapy (P = 0.049), palliative care (P = 0.005), and chemotherapy pharmacists (P = 0.033) were associated with low-job satisfaction. Respondents with low-job satisfaction were less likely to discuss prognosis with their patients compared to those with moderate or high job satisfaction (median 45% of patients v 65% v 75%, P < 0.001). CONCLUSIONS: Globally, 1 in 5 medical oncologists report low job satisfaction. The main correlates of job satisfaction are related to system-level pressures resulting in less time for quality patient care and personal resilience. Improving oncologist job satisfaction will require new approaches to models of care delivery.

Cancer care workforce in Africa: perspectives from a global survey.

BACKGROUND: While the burden of cancer in Africa is rapidly rising, there is a lack of investment in healthcare professionals to deliver care. Here we report the results of a survey of systemic therapy workload of oncologists in Africa in comparison to oncologists in other countries. METHODS: An online survey was distributed through a snowball method via national oncology societies to chemotherapy-prescribing physicians in 65 countries. The survey was distributed within Africa through a network of physicians associated with the African Organisation for Research and Training in Cancer (AORTIC). Workload was measured as the annual number of new cancer patient consults seen per oncologist. Job satisfaction was ranked on a 10-point Likert scale; scores of 9-10 were considered to represent high job satisfaction. RESULTS: Thirty-six oncologists from 18 countries in Africa and 1079 oncologists from 47 other countries completed the survey. Compared to oncologists from other countries, African oncologists were older (median age 51 vs 44 years, p = 0.007), more likely to prescribe chemotherapy and radiation [61% (22/36) vs 10% (108/1079), p < 0.001], less likely to have completed training in their home country [50% (18/36) vs 91% (979/1079), p < 0.001], and more likely to work in the private sector [47% (17/36) vs 34% (364/1079), p = 0.037]. The median number of annual consults per oncologist was 325 in Africa compared to175 in other countries. The proportion of oncologists seeing > 500 consults/year was 31% (11/36) in Africa compared to 12% (129/1079) in other countries (p = 0.001). African oncologists were more likely than global colleagues to see all cancer sites [72% (26/26) vs 24% (261/1079), p < 0.001]. Oncologists in Africa were less likely than other oncologists to have high job satisfaction [17% (6/36) vs 30% (314/1079), p = 0.013]. CONCLUSION: African oncologists within the AORTIC network have a substantially higher clinical workload and lower job satisfaction than oncologists elsewhere in the world. There is an urgent need for governments and health systems to improve the oncologist-to-patient ratio and develop new models of capacity building, retention and skills enhancement to strengthen the wide variety of cancer care systems across continental Africa.

The information needed by Canadian early-stage prostate cancer patients for decision-making: stable over a decade.

OBJECTIVE: To compare information needs for decision-making by similar cohorts of Canadian early-stage prostate cancer patients, at two time points a decade apart. METHODS: Two patient groups (1st-1996, 2nd-2005), diagnosed within the previous 2 years, were surveyed. They rated the importance of having each of 92 questions addressed, using options: essential, desired, no opinion, or avoid. For each essential or desired question, respondents indicated their reasons for wanting the question addressed: to understand, decide, plan, or other. RESULTS: The two groups had similar response rates and demographics. The mean number of questions rated essential for decision-making/patient trended toward more by the later group (13 questions vs 19 questions) but, more importantly, there was wide variation within each group (0-68 questions vs 0-92 questions). The percentage of essential ratings for decision-making per question was highly correlated between the groups. Although almost every question was essential for decision-making to >1 patient, no question was essential to >50% in either group. CONCLUSION: At both times, most Canadian early-stage prostate cancer patients wanted some information specifically for decision-making, however, both the amount and exact details varied considerably amongst patients. PRACTICE IMPLICATION: Decision support for these patients should continue to accommodate wide variation in their information needs.