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Background: Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behavior change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential theoretical frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF) in order to explore the utility of these frameworks in trial recruitment., Methods: We interviewed all nine active study recruiters from a multi-site, open-label pilot trial assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or master's-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of their recruitment activities, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement and informed the thematic analysis., Results: The analysis helped to identify 28 sub-themes across 11 domains. The sub-themes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed., Conclusions: Identified sub-themes can be linked to TDF domains for which effective behavior change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision-making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.

Background: People often face difficult decisions about their health and may later regret the choice that they made. However, little is known about the extent of decision regret in health care or its predictors. We systematically reviewed evidence about the extent of decision regret and its risk factors among individuals making health decisions., Methods: The data sources were Medline, Embase, and reverse citation searches in Google Scholar and Web of Science. Studies using the Decision Regret Scale (DRS) to measure decision regret among individuals making nonhypothetical health decisions were included. There were no restrictions on study design, setting, or language. We extracted characteristics of included studies, measures of central tendency for DRS scores (0 = no regret, 100 = high regret), and all risk factors from published analyses. Quality appraisal was conducted using the Mixed Methods Appraisal Tool. A narrative synthesis was performed owing to the heterogeneity of studies., Results: The initial search yielded 372 unique titles, and 59 studies were included. The overall mean DRS score across studies was 16.5, and the median of the mean scores was 14.3 (standard deviation range = 2.2-34.5) (n = 44 studies). The risk factors most frequently reported to be associated with decision regret in multivariate analyses included higher decisional conflict, lower satisfaction with the decision, adverse physical health outcomes, and greater anxiety levels., Conclusions: The extent of decision regret as assessed with the DRS in nonhypothetical health decisions was often low but reached high levels for some decisions. Several risk factors related to the decision-making process significantly predicted decision regret. Additional research into the psychometrics of the DRS and the relevance of scores for clinicians and patients would increase the validity of decision regret as a patient-reported outcome., (© The Author(s) 2016.)

Objectives: Although informed consent (IC) documents must contain specific elements, inclusion of these elements may be insufficient to encourage high-quality decision making. We assessed the extent to which documents conform to IC standards and how well conformity to decision quality (DQ) standards can be predicted by IC standards, IC document characteristics, and study characteristics., Study Design and Setting: We obtained 139 IC documents for trials registered with ClinicalTrials.gov from study investigators. Using a four-point scale, two raters independently assessed each IC document on 36 IC standard items and 9 DQ items., Results: Overall agreement between raters across all 45 items was 93%. Across the 36 IC standards items, conformity was generally quite high but variable, with 20 items showing conformity of 80% or more and seven items showing conformity of 50% or lower. IC standards concordance, overall length of the IC document, and country of study were all significant predictors of DQ standards but together accounted for less than 20% of the variance in DQ standards., Conclusion: Conformity to recommendations for improving IC documents was relatively high but variable. The extent to which an IC document conformed to these recommendations was only moderately related to whether it conformed to recommendations for improving DQ. Existing IC regulations may not describe the optimal approach to helping people make good study participation decisions., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g. enhanced information or changes to the presentation format) rather than the process of decision making. Patient decision aids support a decision making process about medical options. Decision aids support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes, and provide structured guidance on steps of decision making. They have been shown to be effective for treatment and screening decisions but evidence on their effectiveness in the context of informed consent for clinical trials has not been synthesised., Objectives: To assess the effectiveness of decision aids for clinical trial informed consent compared to no intervention, standard information (i.e. usual practice) or an alternative intervention on the decision making process., Search Methods: We searched the following databases and to March 2015: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; MEDLINE (OvidSP) (from 1950); EMBASE (OvidSP) (from 1980); PsycINFO (OvidSP) (from 1806); ASSIA (ProQuest) (from 1987); WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/); ClinicalTrials.gov; ISRCTN Register (http://www.controlled-trials.com/isrctn/). We also searched reference lists of included studies and relevant reviews. We contacted study authors and other experts. There were no language restrictions., Selection Criteria: We included randomised and quasi-randomised controlled trials comparing decision aids in the informed consent process for clinical trials alone, or in conjunction with standard information (such as written or verbal) or alongside alternative interventions (e.g. paper-based versus web-based decision aids). Included trials involved potential trial participants, or their guardians, being asked to consider participating in a real or hypothetical clinical trial., Data Collection and Analysis: At least two authors independently assessed studies for inclusion, extracted reported data and assessed risk of bias. Findings were pooled where appropriate. We used GRADE to assess the quality of the evidence for each outcome., Main Results: We identified one study (290 randomised participants) that investigated the effectiveness of decision aids compared to standard information in the informed consent process for clinical trials. This study reported two separate decision aid randomised controlled trials (RCTs). The decision aid trials were nested within two different parent trials focusing on breast cancer in postmenopausal women. One trial focused on informed consent for treatment in women who had previously had surgery for ductal carcinoma in situ (DCIS), the other on informed consent for prevention in women at high risk for breast cancer. Two different decision aids were used in these RCTs, and were compared with standard information.The pooled findings highlight the uncertainty surrounding most reported outcomes, including knowledge, decisional conflict, anxiety, trial participation and attrition. There was very low quality evidence that decision aids lower levels of decisional regret to a small degree (MD -5.53, 95% CI -10.29 to -0.76). No data were identified on several prespecified primary outcomes, including accurate risk perception, values-based decision, or whether potential participants recognised that a decision needed to be made, were able to identify features of options that matter most to individuals, or were involved in the decision., Authors' Conclusions: There was insufficient evidence to determine whether decision aids to support the informed consent process for clinical trials are more effective than standard information. Additional well designed, adequately powered clinical trials in more diverse clinical and social populations are needed to strengthen the results of this review. More generally, future research on which outcomes are most relevant for assessment in this context would be helpful.

Background: Dual-process psychological theories argue that clinical decision making is achieved through a combination of experiential (fast and intuitive) and rational (slower and systematic) cognitive processes., Objective: To determine whether emergency physicians perceived their clinical decisions in general to be more experiential or rational and how this compared with other physicians., Methods: A validated psychometric tool, the Rational Experiential Inventory (REI-40), was sent through postal mail to all emergency physicians registered with the College of Physicians and Surgeons of Ontario, according to their website in November 2009. Forty statements were ranked on a Likert scale from 1 (Definitely False) to 5 (Definitely True). An initial survey was sent out, followed by reminder cards and a second survey to non-respondents. Analysis included descriptive statistics, Student t tests, analysis of variance and comparison of mean scores with those of cardiologists from New Zealand., Results: The response rate in this study was 46.9% (434/925). The respondents' median age was 41-50 years; they were mostly men (72.6%) and most had more than 10 years of clinical experience (66.8%). The mean REI-40 rational scores were higher than the experiential scores (3.93/5 (SD 0.35) vs 3.33/5 (SD 0.49), p<0.0001), similar to the mean scores of cardiologists from New Zealand (mean rational 3.93/5, mean experiential 3.05/5). The mean experiential scores were significantly higher for female respondents than for male respondents (3.40/5 (SD 0.49) vs 3.30/5 (SD 0.48), p=0.003)., Conclusions: Overall, emergency physicians favoured rational decision making rather than experiential decision making; however, female emergency physicians had higher experiential scores than male emergency physicians. This has important implications for future knowledge translation and decision support efforts among emergency physicians.

Objective: Informed consent for research has emphasized information provision over support to people making a difficult decision. We assessed the extent to which existing informed consent documents (ICDs) conform to the International Patient Decision Aid Standards for supporting decision making., Study Design and Setting: One hundred thirty-nine ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a four-point scale, two raters assessed each ICD on 32 items., Results: Overall agreement between raters was 95.1% (linear weighted kappa-0.745). For 12 items focused on providing enough information, conformity was above 50% for three, and 0% for another four. For all eight items focused on how to present outcome probabilities, conformity was below 20%. For two items focused on clarifying and expressing values, conformity was below 10%. For two items focused on improving structured guidance, conformity was below 5%. For four items focused on using evidence, one item showed conformity of 74%; all others showed conformity below 5%. For four items focused on transparency, conformity was high (above 60% for two, above 80% for the others)., Conclusions: Existing ICDs do not meet most validated standards for encouraging good decision making. These standards make clear predictions about how one might improve ICDs ensure that research participants are fully informed., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: As patients become more involved in health care decisions, there may be greater opportunity for decision regret. The authors could not find a validated, reliable tool for measuring regret after health care decisions., Methods: A 5-item scale was administered to 4 patient groups making different health care decisions. Convergent validity was determined by examining the scale's correlation with satisfaction measures, decisional conflict, and health outcome measures., Results: The scale showed good internal consistency (Cronbach's alpha = 0.81 to 0.92). It correlated strongly with decision satisfaction (r = -0.40 to -0.60), decisional conflict (r = 0.31 to 0.52), and overall rated quality of life (r = -0.25 to -0.27). Groups differing on feelings about a decision also differed on rated regret: F(2, 190) = 31.1, P < 0.001. Regret was greater among those who changed their decisions than those who did not, t(175) = 16.11, P < 0.001., Conclusions: The scale is a useful indicator of health care decision regret at a given point in time.