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Background: Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice., Methods: We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored., Results: Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2-19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0-11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5-8 years and one trial publishing after 14 years., Conclusions: PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future., (© The Author(s) 2019. Published by Oxford University Press.)

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.

Background: The effectiveness of patient decision aids (PtDA) is rarely evaluated in the "real world" where patients vary in their preferences related to decision support., Purpose: To determine how Canadian patients use and evaluate our widely available PtDA for early-stage prostate cancer treatment with its 8 components., Methods: Google Analytics and online tracking provided usage information. A Usability Assessment (UA) following the PtDA provided evaluation data; main outcomes [scale: 1 (strongly disagree) to 5 (strongly agree)] were (a) the aid was helpful, and (b) I would recommend it to other patients., Results: Usage data were from 993 users, and UAs from 168 of them. Mean "helpfulness" score was 4.1(5 max); mean "recommend" score was 4.2 (5 max). For each PtDA component, there was no significant difference on each main outcome, between those who used it and those who did not., Conclusion: Overall, patients who completed the UA rated the PtDA as helpful and would recommend it to other patients. The widely available PtDA accommodated expected variation in decision support desired, and helpfulness was not associated with variation in components used., Practice Implication: The internet can be an effective medium for making appropriately designed decision support widely available to prostate cancer patients., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Purpose: To identify the information that post-menopausal women with hormone-receptor positive, early-stage breast cancer want, to help them decide among six treatment options for adjuvant-endocrine therapy., Methods: We surveyed women with early-stage breast cancer who were eligible for adjuvant endocrine-therapy 3-18 months earlier. Participants rated the importance of getting each of 95 questions answered before this decision is made (options: essential/desired/not important/avoid). For questions rated essential or desired, participants identified the purpose(s) for having the question answered: to help them understand, make the decision, plan, or other. Participants indicated the role they played in their actual decision and the role they would prefer if the decision was made today. They also indicated whether they felt they had had a choice of endocrine therapy treatments., Results: 188 of 343 questionnaires were returned (response rate 55%). Mean age was 67 yr (range 38-88 yr); 76% were married, and 39% had secondary school education or less. On average, respondents rated 18 questions (range 0-94) essential for decision making. Each question was rated essential for decision making by ≥ 7% of participants but only 1 question by >50%. Regarding roles, 89% of respondents had participated in their actual decision and would want to again; an additional 9% had not participated in their actual decision but would want to at the time of the survey. The percentage of respondents who felt they had no choice of endocrine therapy treatments varied between centres, 25% vs 41% and 49%., Conclusions: Most patients want to participate in the decision but they vary widely in the amount and which specific details they want to help them make the decision., Implication: The wide variation in questions considered important means the support should be tailored to the needs of the individual patient., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs., Methods: A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance., Results: Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors., Conclusions: ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.

Background: We developed a decision aid for patients with curable prostate cancer based on Svenson's DiffCon Theory of Decision Making. This study was designed to determine if surrogate patients using the aid could understand the information presented, complete all tasks, show evidence of differentiation, and arrive at a preferred treatment choice., Methods: Men, at least 50 years old and never diagnosed with prostate cancer, were recruited through local advertisements. Participants were asked to imagine that they were a case-scenario patient. Then they completed the decision aid interview, which included three components: (i) information presentation, with comprehension questions, (ii) exercises to help identify attributes important to the decision, and (iii) value-clarification exercises., Results: Sixty-nine men volunteered. They had a mean age of 61.2 (range 50-83) years, 37% had no formal education beyond high school, and 87% were living with a partner. All participants completed all aspects of the interview. They answered an average of 10 comprehension questions each, with a mean of 94.7% correct without a prompt. Each attribute in the information presented was identified by at least one participant as important to his decision. Participants identified a median of five attributes as important (ranges 1-14) at each of three points during the interview; 75% changed at least one important attribute during the interview. Forty-nine per cent of participants also identified attributes as important that were not included in the presented information. Participants showed a wide range of values in each of seven trade-off exercises. Eighty-eight per cent of participants showed evidence of differentiation; 75% had a clear treatment preference by the end of the interview., Conclusions: Our decision aid appears to meet its goals for surrogate patients and illustrates the strengths of the DiffCon theory. The ability of the aid to accommodate wide variability, both in information needs and in important attributes, is a particular strength of the decision aid. It now requires testing in patients with prostate cancer.

The study was designed to determine which formats for displaying quantities, such as probabilities of treatment risks and benefits, are perceived most accurately and easily by patients. Accuracy and speed of processing were compared for six different presentation formats: pie charts, vertical bars, horizontal bars, numbers, systematic ovals, and random ovals. Quantities were used in two tasks: a choice task that required larger/smaller judgments and an estimate task that required more precise evaluation. The impacts of blue-yellow color and of a treatment-decision context on performance in the two tasks were also investigated. The study included four experiments. Taken together the results suggest that the formats best for making a choice differ from those best for estimating the size of an amount. For making a choice, vertical bars, horizontal bars, numbers, and systematic ovals were equally well perceived; pie charts and random ovals caused slower and less accurate performances. For estimating, numbers led to the most accurate estimates, followed by systematic ovals. The other four formats led to the least accurate estimates. Color and context did not alter which formats were best.

Purpose: To determine the questions that recently diagnosed early-stage prostate cancer patients think should be addressed with patients like themselves., Study Population: 56 patients diagnosed as having early-stage prostate cancer within the previous year., Methods: Surveys distributed to the patients included 93 questions that might be considered important. Respondents judged the importance (essential/desired/no opinion/avoid) of addressing each question, and indicated why those "essential" or "desired" were important., Results: 38 patients (68%) responded. Agreement on question importance, overall, was rather poor (mean 41.6%, kappa 0.17). There were, however, 20 questions that at least 67% of the respondents agreed were essential to address and 12 that they agreed were not essential. No question was relevant to the treatment decisions of more than 50% of respondents, but 91 questions were relevant to at least one respondent's decision., Conclusions: Although there was enough agreement to define a core set of questions that should be addressed with most patients, each of the remaining questions was also considered essential to some people. The core set, therefore, would not be adequate to satisfy any one patient's essential information needs. Whereas most questions would be needed to cover all patients' decision needs, only some are needed for any given patient. Such variability in information needs means that the subjective standard is the only viable legal standard for judging the adequacy of provision of information for the treatment decision.

This study examined responses of 21 lung cancer outpatients to questions about their desired and actual levels of involvement in treatment decisions, and about information needed for treatment decision-making. A 'treatment trade-off' interview was used to assess patients' preferences for hypothetical treatment options. Desired roles in decisions are examined in relation to treatment preference and information needs. Forty-three percent of patients recalled desiring an active/collaborative role in their real treatment decision. For 29% of patients, there was a discrepancy between their recalled desired role and their recalled actual role; in each of these cases the patient had been less involved in the decision than they had desired. At the time of the interview (mean 26 months post-treatment), 57% of patients desired an active or collaborative role in treatment decisions. The majority of patients rated the following types of information as 'essential' to treatment decisions: details of the treatment regimen, early and late side-effects, survival, and effects of treatment on disease symptoms. The data suggest that: we should be attentive to the individual's desired role in treatment decisions at each step of care to avoid a mismatch between desired and actual involvement; desired role in decision-making does not predict treatment preference; and patients generally want a wide variety of information on treatment options in order to participate in treatment decisions., (Copyright 1999 John Wiley & Sons, Ltd.)