BackgroundPatient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs.MethodsAn international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist.ResultsThe SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies.ConclusionThe SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist.

Background The Shared Decision Making (SDM) Process scale is a short patient-reported measure of the amount of SDM that occurs around a medical decision. SDM Process items have been used previously in studies of surgical decision making and exhibited discriminant and construct validity. Method Secondary data analysis was conducted across 8 studies of 11 surgical conditions with 3965 responses. Each study contained SDM Process items that assessed the discussion of options, pros and cons, and preferences. Item wording, content, and number of items varied, as did inclusion of measures assessing decision quality, decisional conflict (SURE scale), and regret. Several approaches for scoring, weighting, and the number of items were compared to identify an optimal approach. Optimal SDM Process scores were compared with measures of decision quality, conflict, and regret to examine construct validity; meta-analysis generated summary results. Results Although all versions of the scale were highly correlated, a short, partial credit, equally weighted version of the scale showed favorable properties. Overall, higher SDM Process scores were related to higher decision quality ( d = 0.18, P = 0.029), higher SURE scale scores ( d = 0.57, P < 0.001), and lower decision regret ( d = −0.34, P < 0.001). Significant heterogeneity was present in all validity analyses. Limitations Included studies all focused on surgical decisions, several had small sample sizes, and many were retrospective. Conclusion SDM Process scores showed resilience to coding changes, and a scheme using the short, partial credit, with equal weights was adopted. The SDM Process scores demonstrated a small, positive relationship with decision quality and were consistently related to lower decision conflict and less regret, providing evidence of validity across several surgical decisions.

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This Explanation and Elaboration (E&E) article expands on the 26 items in the Standards for UNiversal reporting of Decision Aid Evaluations guidelines. The E&E provides a rationale for each item and includes examples for how each item has been reported in published papers evaluating patient decision aids. The E&E focuses on items key to reporting studies evaluating patient decision aids and is intended to be illustrative rather than restrictive. Authors and reviewers may wish to use the E&E broadly to inform structuring of patient decision aid evaluation reports, or use it as a reference to obtain details about how to report individual checklist items.

Background: Current guidelines recommend shared surgical decision-making, yet it is unclear whether shared decisionmaking improves health outcomes in patients who are considering knee and hip replacement. The purpose of the present study was to examine whether patients who made high-quality, informed, patient-centered (IPC) decisions had better health outcomes, higher satisfaction, and less decision regret compared with those who made lower-quality decisions.Methods: A multisite, randomized study of 2 decision aids for patients with hip and knee osteoarthritis was utilized to collect data on decision-making and health outcomes at 2 time points: shortly after the initial surgical evaluation and about 6 months after treatment. We calculated the percentage of patients who made an IPC decision and examined the a priori hypotheses that IPC decisions would be associated with better health outcomes, satisfaction, and less regret at 6 months. Linear and logistic regression models were utilized to examine the relationships. Results:The analytic sample included 854 patients with a mean age of 65 years (standard deviation, 9 years), of whom 58% were female, 93% were White non-Hispanic, 67% had knee (compared with hip) osteoarthritis, and 62% underwent operative treatment within 6 months of the initial evaluation. The majority of patients (68%) made IPC decisions. The IPC group had significantly larger gains in quality of life (mean difference in EuroQol-5 Dimension, 0.04; 95% confidence interval [CI], 0.02 to 0.07; p < 0.001) compared with the non-IPC group. For knee patients, the IPC group also had significantly better Knee injury and Osteoarthritis Outcome Scores (mean difference, 4.9; 95% CI, 1.5 to 8.3; p = 0.004), higher satisfaction (adjusted odds ratio [aOR], 1.7; 95% CI, 1.2 to 2.3; p = 0.003), much better pain relief (aOR, 2.1; 95% CI, 1.3 to 3.5; p = 0.002), and were more likely to have no decision regret (aOR, 2.3; 95% CI, 1.3 to 4.1; p = 0.003). For hip patients, IPC decisions were not associated with better Harris hip scores or satisfaction and were associated with more regret.Conclusions: Higher-quality decisions predicted small improvements in health outcomes, as well as greater satisfaction and less regret for patients with knee osteoarthritis, but not for patients with hip osteoarthritis.

Background In 2014, a systematic review found large gaps in the quality of reporting of measures used in 86 published trials evaluating the effectiveness of patient decision aids (PtDAs). The purpose of this study was to update that review. Methods We examined measures of decision making used in 49 randomized controlled trials included in the 2014 and 2017 Cochrane Collaboration systematic review of PtDAs. Data on development of the measures, reliability, validity, responsiveness, precision, interpretability, feasibility, and acceptability were independently abstracted by 2 paired reviewers. Results Information from 273 measures was abstracted, and 109 of these covered the core domains of decision processes ( n = 55) and decision quality including informed choice/knowledge ( n = 48) and values-choice concordance ( n = 12). Very few studies reported data on the performance and clinical sensibility of measures, with reliability (23%) and validity (6%) being the most common. Studies using new measures were less likely to include information about their psychometric performance compared with previously published measures. Limitations The review was limited to reporting of measures in studies included in the Cochrane review and did not consult prior publications. Conclusion There continues to be very little reported about the development or performance of measures used to evaluate the effectiveness of PtDAs in published trials. Minimum reporting standards have been published, and efforts to require investigators to use them are needed.

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Background The Shared Decision Making (SDM) Process scale is a brief, patient-reported measure of SDM with demonstrated validity in surgical decision making studies. Herein we examine the validity of the scores in assessing SDM for cancer screening and medication decisions through standardized videos of good-quality and poor-quality SDM consultations. Method An online sample was randomized to a clinical decision—colon cancer screening or high cholesterol—and a viewing order—good-quality video first or poor-quality video first. Participants watched both videos, completing a survey after each video. Surveys included the SDM Process scale and the 9-item SDM Questionnaire (SDM-Q-9); higher scores indicated greater SDM. Multilevel linear regressions identified if video, order, or their interaction predicted SDM Process scores. To identify how the SDM Process score classified videos, area under the curve (AUC) was calculated. The correlation between SDM Process score and SDM-Q-9 assessed construct validity. Heterogeneity analyses were conducted. Results In the sample of 388 participants (68% white, 70% female, average age 45 years) good-quality videos received higher SDM Process scores than poor-quality videos ( Ps < 0.001), and those who viewed the good-quality high cholesterol video first tended to rate the videos higher. SDM Process scores were related to SDM-Q-9 scores ( rs > 0.58; Ps < 0.001). AUC was poor (0.69) for the high cholesterol model and fair (0.79) for the colorectal cancer model. Heterogeneity analyses suggested individual differences were predictive of SDM Process scores. Conclusion SDM Process scores showed good evidence of validity in a hypothetical scenario but were lacking in ability to classify good-quality or poor-quality videos accurately. Considerable heterogeneity of scoring existed, suggesting that individual differences played a role in evaluating good- or poor-quality SDM conversations.