Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial.

BACKGROUND & AIMS: Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn's disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. METHODS: Patients with pediatric Crohn's disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12-36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. RESULTS: Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45-1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55-1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19-0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49-1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24-2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. CONCLUSIONS: Among adalimumab but not infliximab initiators, patients with pediatric Crohn's disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. CLINICALTRIALS: gov, Number: NCT02772965.

Young adults' reasoning for involving a parent in a genomic decision-making research study.

Young adults have increasing genomic testing opportunities; however, little is known about how equipped they feel about making decisions to learn personal genomic information. We conducted qualitative interviews with 19 young adults, ages 18-21 years old, enrolled in a research study where they made decisions about learning personal genomic risk for developing preventable, treatable, and adult-onset conditions and carrier status for autosomal recessive conditions. Participants had the option to include a parent in their study visit and the decision-making process. The goal of this project was to explore young adults' reasons for involving or not involving a parent in the study and to assess young adults' perspectives about parental roles in their healthcare. Nine participants included a parent in the study and ten did not include a parent. Eleven participants received genomic test results before the interview, while eight participants had not yet received their results at the time of the interview. The study team developed a coding guide and coded interview transcripts inductively and deductively using an interpretive descriptive-analytic approach. Logistical issues dominated solo participants' reasons for not involving a parent in the study, whereas those who involved a parent often cited a close relationship with the parent and the parent's previous involvement in the participant's healthcare as reasons for involving them. Both groups of participants described gradually transitioning to independent healthcare decision-making with age and felt their comfort in medical decision-making depends on the severity of and their familiarity with the situation. Participants recommended that future genomic researchers or clinicians give young adults the option to involve a parent or friend as a support person in research or clinical visits. Although young adults may have different journeys toward independent healthcare decision-making, some may benefit from continued parental or peer involvement after reaching the age of legal adulthood.

Pilot trial of iBDecide: Evaluating an online tool to facilitate shared decision making for adolescents and young adults with ulcerative colitis.

INTRODUCTION: This pilot, randomized controlled trial aimed to evaluate the usability, among adolescents and young adults (AYAs) with ulcerative colitis (UC), of a web-based tool ('iBDecide') designed to facilitate shared decision making (SDM). METHODS: AYAs with UC (n = 35) were randomized to intervention (iBDecide, n = 14) and control (n = 12) arms before a scheduled clinic visit. We measured the usability of iBDecide, SDM, preferred decision-making style, decision conflict and intervention use. RESULTS: Participants in the intervention group found iBDecide easy to use and agreed that it made them feel ready to participate in decision making and that they would use it to prepare for appointments. There were 130 visits to iBDecide, lasting on average 3 min, 41 s. The medication and nutrition trackers were among the most-viewed pages. Pages specifically designed to facilitate SDM were viewed only four times. Across groups, too few participants reported making decisions during clinic visits for decision-related measures to be reported. CONCLUSIONS: This pilot trial provides evidence for the usability of iBDecide and guidance for developing a larger-scale trial of a combined web-based and in-clinic SDM intervention. Overall, iBDecide shows promise in engaging AYAs with UC in SDM and condition management. PATIENT OR PUBLIC CONTRIBUTION: Patients, specifically AYAs with UC, and healthcare providers were involved in the design of this study's intervention, iBDecide. Additionally, the research team, from study conception to manuscript writing, included a young adult with inflammatory bowel disease. CLINICAL TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT04207008).

Use of language in the medical decision-making process for biologic therapy: Youth and parent perspectives.

BACKGROUND: Youth with chronic illnesses and their parents make complex medical decisions and also need to develop medical decision-making skills for transition of care to adult care. The use of inclusive (e.g. 'we decided …') and exclusive (e.g. 'they decided …') language in youth and parents' medical decision-making experiences provides insights into perceptions of engagement. This study assessed youth and parents' perceptions of engagement in medical decision-making about biologic therapy. METHODS: This exploratory mixed-methods secondary analysis of semistructured interview data included youth with juvenile idiopathic arthritis (JIA) and Crohn's disease (CD) and parents. Iterative qualitative coding of interviews generated themes. Exploratory analyses of variance (ANOVAs) and analyses of covariance (ANCOVAs) investigated differences in language use between youth and parents. RESULTS: Parents used more inclusive language in perceptions of medical decision-making experiences than youth, which exploratory analyses found significant (p < 0.05). Youth used more exclusive language than parents in perceptions of medical decision-making. CONCLUSION: This research suggests that youth with chronic illnesses perceived limited engagement in medical decision-making, with parents perceiving higher engagement. This presents challenges for youth as they prepare for the transition to adult care. Future research should assess how inclusive and exclusive language use impacts psychosocial and health outcomes.

Shared Decision Making About Starting Anti-TNFs: A Pediatric Perspective.

Shared decision making (SDM) is central to patient-centered medicine and has the potential to improve outcomes for pediatric patients with inflammatory bowel diseases. We surveyed specialists about their use of SDM in the decision to start a tumor necrosis factor-α inhibitor in pediatric patients. Results were compared between those who reported using SDM and those who did not. Of 209 respondents, 157 (75%) reported using SDM. Physician/practice characteristics were similar between users and nonusers. There were no statistically significant differences between groups in the components deemed important to the decision-making process nor the number of barriers or facilitators to SDM. Exploratory analyses suggested that physicians using SDM were more accepting of adolescent involvement in the decision-making process. Our results question the effectiveness of using reported barriers and facilitators to guide interventions to improve use of SDM, and suggest further work is needed to understand the adolescent role in decision making.

Physicians' Perceptions of Shared Decision Making in Chronic Disease and Its Barriers and Facilitators.

This study assessed pediatric physicians' use of shared decision making (SDM) in 2 chronic conditions. Most physicians indicated that parent and adolescent trust and emotional readiness facilitated SDM, physicians' preferred approach to decision making. At the same time, they perceived few barriers, other than insurance limitations, to using SDM.

High Levels of Decisional Conflict and Decision Regret When Making Decisions About Biologics.

OBJECTIVES: The aim of the study was to understand the association between parents' perceptions of the decision process and the decision outcomes in decisions about the use of biologics in pediatric chronic conditions. METHODS: We mailed surveys to parents of children with inflammatory bowel disease or juvenile idiopathic arthritis who had started treatment with biologics in the prior 2 years and were treated at either of 2 children's hospitals. The survey included measures of the decision process, including decision control and physician engagement, and decision outcomes, including conflict and regret. We used means and frequencies to assess the response distributions. General linear models were used to test the associations between decision process and decision outcomes. RESULTS: We had 201 respondents (response rate 54.9%). Approximately 47.0% reported using shared decision making. Each physician engagement behavior was experienced by the majority of parents, with the highest percentage reporting that their child's physician used language they understood and listened to them. Approximately 48.5% of parents had decisional conflict scores of 25 or greater, indicating high levels of conflict. Approximately 28.2% had no regret, 31.8% had mild regret, and the remaining 40.0% had moderate to severe regret. Shared decision making was not associated with improved decisional conflict, but physician engagement behaviors were associated with both decisional conflict and regret. CONCLUSIONS: Improving decision outcomes will require more than just focusing on who parents perceive as controlling the final decision. Developing interventions that facilitate specific physician engagement behaviors may decrease parents' distress around decision making and improve decision outcomes.

Making decisions about chronic disease treatment: a comparison of parents and their adolescent children.

OBJECTIVE: To compare factors considered by parents to those considered by adolescents making decisions about chronic disease treatments. METHODS: We conducted individual interviews with 15 parent-adolescent dyads in which the adolescent had either juvenile idiopathic arthritis or Crohn's disease. Questions focused on treatment decisions, with an emphasis on the factors that influenced each individual's preferences related to biologic therapies. A multidisciplinary team developed a coding structure. All interviews were coded by two people with disagreements resolved through discussion. We used content analysis and coding matrices to examine decision factors within and between parent-adolescent dyads. RESULTS: Parents and adolescents both participated in decisions about treatment with biologic therapies but considered decision factors differently. In only half of cases did parents and adolescents agree on the factor that most influenced their decision. Although their decision factors often fell into similar categories (e.g. treatment risks, quality of life), in many cases the specifics varied between adolescents and their parents. Adolescents were more likely to focus on immediate treatment effects and quality of life while parents took a longer term view of the decision. Agreement within dyads was most consistent when a special circumstance influenced the treatment decision. CONCLUSIONS: Differences regarding influential decision factors exist within parent-adolescent dyads. Continued research is needed to determine the extent to which such differences are due to individual preferences or to variations in the information available to each person. Future decision support interventions will need to address parents' and adolescents' potentially disparate views and information needs.

Shared Decision Making in the Care of Children with Developmental and Behavioral Disorders.

OBJECTIVE: Shared decision making (SDM) is most needed when there are multiple treatment options and no "right" choice. As with quality and experience of care, frequency of SDM may vary by health condition. The objectives of this study were (1) to compare parent report of SDM between a physical and a behavioral health condition and; (2) to compare parent report of SDM between two different behavioral health conditions. METHODS: Data on children age 3-17 years with asthma, attention deficit/hyperactivity disorder (ADHD), and/or autism spectrum disorder (ASD) were drawn from the 2009/10 National Survey of Children with Special Health Care Needs. Weighted logistic regression was used to compare a parent-reported, composite measure of SDM. Analyses controlled for sociodemographic factors that may influence experience of SDM. RESULTS: Compared to parents of children with asthma, parents of children with ADHD were significantly less likely to report experiencing consistent SDM (AOR 0.73). Compared to parents of children with ADHD, those of children with ASD had significantly lower odds of experiencing consistent SDM (AOR 0.59). Those with both ADHD and ASD had the same odds as those with ASD alone of experiencing consistent SDM. CONCLUSION: Use of SDM is particularly limited in developmental and behavioral conditions, such as ADHD and ASD. These data suggest that challenges to implementing SDM may include disease type, complexity, and use of specialty care. Research to identify specific barriers and facilitators of SDM is needed to inform interventions that will promote SDM in developmental and behavioral conditions.

Real life clinic visits do not match the ideals of shared decision making.

OBJECTIVE: To use observation to understand how decisions about higher-risk treatments, such as biologics, are made in pediatric chronic conditions. METHODS: Gastroenterology and rheumatology providers who prescribe biologics were recruited. Families were recruited when they had an outpatient appointment in which treatment with biologics was likely to be discussed. Consent/assent was obtained to video the visit. Audio of the visits in which a discussion of biologics took place were transcribed and analyzed. Our coding structure was based on prior research, shared decision making (SDM) concepts, and the initial recorded visits. Coded data were analyzed using content analysis and comparison with an existing model of SDM. RESULTS: We recorded 21 visits that included discussions of biologics. In most visits, providers initiated the decision-making discussion. Detailed information was typically given about the provider's preferred option with less information about other options. There was minimal elicitation of preferences, treatment goals, or prior knowledge. Few parents or patients spontaneously stated their preferences or concerns. An implicit or explicit treatment recommendation was given in nearly all visits, although rarely requested. In approximately one-third of the visits, the treatment decision was never made explicit, yet steps were taken to implement the provider's preferred treatment. CONCLUSIONS: We observed limited use of SDM, despite previous research indicating that parents wish to collaborate in decision making. To better achieve SDM in chronic conditions, providers and families need to strive for bidirectional sharing of information and an explicit family role in decision making.

Measure of Caregiver Attention-Deficit/Hyperactivity Disorder Knowledge Is Responsive to Decision Aid on Treatment for Attention-Deficit/Hyperactivity Disorder.

OBJECTIVE: Adapt and test a measure of knowledge for caregivers of children with attention-deficit/hyperactivity disorder (ADHD) and evaluate the impact of the information component of a decision aid (DA) on participant knowledge. METHODS: A set of seven knowledge items were created based on prior knowledge measures and clinical guidelines. As part of a larger cross-sectional survey study of caregivers of children diagnosed with ADHD, caregivers were randomized to one of two arms: 1) a DA arm, where participants reviewed the information component of the Cincinnati Children's Hospital's DA, and 2) a control arm, where participants were not shown a DA. All participants completed the seven knowledge items. Knowledge items were assessed for difficulty, quality of distractors, acceptability, and redundancy. Total knowledge scores (0-100) for the DA and control arm were compared. RESULTS: Caregivers were assigned to the DA arm (n = 243) or the control arm (n = 260). All 7 knowledge items were retained as no items were too difficult or too easy, all response options were used, there were little missing data, and no items were redundant. The overall knowledge score was normally distributed, and almost covered the full range of scores (5-100). Those who received the DA component had higher knowledge scores (M=68, SD=23) than those who did not receive the DA component (M=60, SD=19, P < .01, d=0.4). CONCLUSIONS: The Caregiver ADHD Knowledge (CAKe) measure was acceptable and demonstrated construct validity as those who were assigned to review the DA component demonstrated greater knowledge than those who were not assigned to review the DA component.

Parents' information needs in tumor necrosis factor-α inhibitor treatment decisions.

OBJECTIVE: The aim of the study was to describe parents' experiences and the information used when making decisions about tumor necrosis factor-α inhibitor (TNFαi) treatment. METHODS: We interviewed parents of children with Crohn disease (CD) or juvenile idiopathic arthritis who had experience deciding about TNFαi treatment. Interview questions focused on information used to make decisions and factors that influenced decision making. We used thematic analysis for all coding and analysis. Coding structure was developed by a multidisciplinary team review of the initial interviews. Two coders then coded the remaining interviews, compared coding, and resolved disagreements through discussion. Data were analyzed by thematic grouping and then compared between diseases. RESULTS: We interviewed 35 parents. For nearly all parents the decision about TNFαi treatment was the most challenging medical decision they had made; however, parents of children with CD experienced more stress and anxiety than did other parents. Both groups of parents sought information from multiple sources including health care providers, the Internet, and social contacts. They looked for information related to treatment effectiveness, adverse effects, and other individuals' treatment experiences. In CD, information was used to help make the decision, whereas in juvenile idiopathic arthritis it was used to confirm the decision. CONCLUSIONS: The decision-making experience, and associated information seeking, leaves some parents with long-lasting concerns and worry about TNFαi treatment. Providing parents with structured decision-making support may lead to more effective and efficient decision making, decreased psychosocial distress, and, ultimately, improved outcomes for their children.

Adolescents' and Parents' Perspectives on a Novel Decision-Making Process for Return of Results in Genomic Research.

To understand whether they found a two-step decision process helpful and why, adolescent-parent dyads participating in a study investigating return of genomic testing results were asked about their decision-making experience. Responses were qualitatively coded and analyzed using thematic analysis. Adolescents and parents found both joint and independent decision-making stages helpful. Regarding independent decision-making, adolescents appreciated exercising independence, while parents valued both adolescent and parental independence. Joint decision-making allowed each to hear the other's viewpoints. Some found joint decision-making irrelevant but recognized it might help others. Overall, adolescents and parents had similar reasons for finding the two-step decision-making process helpful. Our findings support using such a process for engaging parents and adolescents in challenging research and clinical decisions.

Patient Preferences in Diagnostic Imaging: A Scoping Review.

BACKGROUND: As new diagnostic imaging technologies are adopted, decisions surrounding diagnostic imaging become increasingly complex. As such, understanding patient preferences in imaging decision making is imperative. OBJECTIVES: We aimed to review quantitative patient preference studies in imaging-related decision making, including characteristics of the literature and the quality of the evidence. METHODS: The Pubmed, Embase, EconLit, and CINAHL databases were searched to identify studies involving diagnostic imaging and quantitative patient preference measures from January 2000 to June 2022. Study characteristics that were extracted included the preference elicitation method, disease focus, and sample size. We employed the PREFS (Purpose, Respondents, Explanation, Findings, Significance) checklist as our quality assessment tool. RESULTS: A total of 54 articles were included. The following methods were used to elicit preferences: conjoint analysis/discrete choice experiment methods (n = 27), contingent valuation (n = 16), time trade-off (n = 4), best-worst scaling (n = 3), multicriteria decision analysis (n = 3), and a standard gamble approach (n = 1). Half of the studies were published after 2016 (52%, 28/54). The most common scenario (n = 39) for eliciting patient preferences was cancer screening. Computed tomography, the most frequently studied imaging modality, was included in 20 studies, and sample sizes ranged from 30 to 3469 participants (mean 552). The mean PREFS score was 3.5 (standard deviation 0.8) for the included studies. CONCLUSIONS: This review highlights that a variety of quantitative preference methods are being used, as diagnostic imaging technologies continue to evolve. While the number of preference studies in diagnostic imaging has increased with time, most examine preventative care/screening, leaving a gap in knowledge regarding imaging for disease characterization and management.

Decision Support Needs for Transgender and Gender-Diverse Youth and Families: A Patient-Centered Needs Assessment.

PURPOSE: Due to the intertwining of medical and social decision-making, new approaches to shared decision-making are likely needed for supporting decisions related to the care of transgender and gender-diverse (TGD) adolescents. Prior to developing decision support interventions for TGD youth, a decision support needs assessment must be completed. METHODS: Self-identified TGD youth, family members of TGD youth, clinicians caring for this population, and community advocates participated in one of six group level assessments (GLAs). GLA is a structured, participatory qualitative method that engages diverse groups of stakeholders in generating and evaluating ideas on the topic of interest. Upon completion of all GLAs, a survey was developed and distributed to GLA participants inviting them to rank ideas generated during the GLAs. RESULTS: Six major themes emerged from the GLAs regarding decision support needs, including: improving healthcare provider skills and education, increasing access to support outside the healthcare system, strengthening community and societal support, developing special information resources, supporting youth in leading decision-making about transition, and modifying the healthcare system. In the follow-up survey, improving healthcare provider skills and education was the most commonly chosen top priority. DISCUSSION: Participants identified decision support needs for TGD youth and their families that were mostly distinct from traditional decision support approaches. Participants' focus on the need to improve healthcare provider skills and education provides an opportunity to couple gender-focused education with shared decision-making skills, an approach that may be more sustainable than tools for specific decisions.

Supporting Gender-Related Medical Decision Making for Transgender and Gender-Diverse Individuals: A Scoping Review.

Purpose: Transgender and gender-diverse (TGD) individuals and their families face numerous challenging decisions. To better understand their decision processes, we conducted a scoping review of the existing literature and of decision-support tools in use at pediatric gender-care clinics. Methods: We searched PubMed, EMBASE, Scopus CINAHL, PsychINFO, and EBM Reviews for studies that were original research focused on decisions, decision making, or decision support for TGD individuals and/or their families. All studies were reviewed for inclusion by at least two researchers. Additionally, we reviewed clinical tools used to support decision making by TGD youth and their families. Results: We retrieved 3306 articles. Thirty-two met criteria for data extraction. Studies focused on three major decisions: gender-confirming surgery, fertility preservation, and gender-affirming hormone therapy. Several themes that cut across clinical topics emerged: decision-making processes, decision-making roles, and sources of decision support. Only three articles focused on decision-support interventions, two of which discussed development of support tools and one evaluated a class designed to help with surgical decision making. None of the clinical tools reviewed met criteria for a decision aid. Conclusions: There is a dearth of studies related to decision support interventions, an absence validated by the resources currently in clinical use. This scoping review suggests an opportunity for the development of tools to aid in the decision-making processes for TGD youth and their families.

Pediatric Caregiver Version of the Shared Decision Making Process Scale: Validity and Reliability for ADHD Treatment Decisions.

OBJECTIVE: Shared decision making (SDM) is recommended for common pediatric conditions; however, there are limited data on measures of SDM in pediatrics. This study adapted the SDM Process scale and examined validity and reliability of the scale for attention-deficit/hyperactivity disorder (ADHD) treatment decisions. METHODS: Cross-sectional survey of caregivers (n = 498) of children (aged 5-13) diagnosed with ADHD, who had made a decision about ADHD medication in the last 2 years. Surveys included the adapted SDM Process scale (scores range 0-4, higher scores indicate more SDM), decisional conflict, decision regret, and decision involvement. Validity was assessed by testing hypothesized relationships between these constructs. A subset of participants was surveyed a week later to assess retest reliability. RESULTS: Pediatric Caregiver version of the SDM Process scale (M = 2.8, SD = 1.05) showed no evidence of floor or ceiling effects. The scale was found to be acceptable (<1% missing data) and reliable (intraclass correlation coefficient = 0.74). Scores demonstrated convergent validity, as they were higher for those without decisional conflict than those with decisional conflict (2.93 vs 2.46, P < .001, d = 0.46), and higher for caregivers who stated they made the decision with the provider than those who made the decision themselves (3.0 vs 2.7; P = .003). Higher scores were related to less regret (r = -0.15, P < .001), though the magnitude of the relationship was small. CONCLUSIONS: The adapted Pediatric Caregiver version of the SDM Process scale demonstrated acceptability, validity and reliability in the context of ADHD medication decisions made by caregivers of children 5-13. Scores indicate pediatricians generally involve caregivers in decision making about ADHD medication.

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention.

OBJECTIVE: We conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD). METHODS: We recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms. RESULTS: Two out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm. CONCLUSIONS: This pilot trial provides important guidance for developing a larger scale trial of a modified intervention. PRACTICE IMPLICATIONS: Overall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.

Developing video education materials for the return of genomic test results to parents and adolescents.

Objective: To describe the development, implementation, and revision of a video to provide information about genomic testing and the return of genomic research results to adolescents and parents. Methods: Formative, community-engaged research was conducted in three stages: development, implementation, and revision. Existing research participant advisory groups were used for focus groups and convenience sampling was used for interviews. Participants included parents, young adults without children, and adolescents. Transcripts of recorded sessions were used for formative analysis. Results: Video was the preferred format for delivering genomic testing information to adolescents during the development stage. During implementation, adolescents identified video length as an impediment to recall. During the revision stage, participants preferred the video in separate short segments, supported plan to require only one short video and leaving other short videos optional. Participants were divided on whether the required short video provided enough information, but all participants reported that watching additional videos would not have changed their decisions about receiving test results. Conclusion: Genomic education videos should be brief (<4 mins) to improve the odds that participants will view the entirety of any required video. Innovation: The development of participant materials should incorporate plans for monitoring implementation and plans for revising materials.

Integrating shared decision making into trial consent: A nested, cluster-randomized trial.

OBJECTIVE: Using a nested, cluster-randomized trial, we tested the hypothesis that a shared decision-making intervention, as part of consent, would improve study-related knowledge. METHODS: We developed a shared decision-makingintervention then randomized sites in a clinical trial to intervention or control (standard consent). We collected participants' knowledge (primary outcome) and decisional support data. Other data came from a clinical registry and research coordinator surveys. We compared outcomes between study arms using generalized estimating equation models, accounting for clustering. We used qualitative description to understand variation in intervention use. RESULTS: 265 individuals, from 34 sites, enrolled in the parent trial during our study period. Of those, 241 participants completed our survey. There was no knowledge difference between arms (mean difference = 0.56 (95 %CI: -3.8, 4.9)). Both groups had a considerable number of participants with misunderstandings. We also found no difference for decisional support (mean difference = 1.5 (95 %CI: -1.8, 4.8)) or enrollment rate between arms. Clinician use of the intervention varied between sites. CONCLUSIONS: We found no differences in outcomes but demonstrated the feasibility and acceptability of incorporating a shared decision-making intervention into consent. PRACTICE IMPLICATIONS: Future work should consider adapting our intervention to other trials and more robust measurement strategies.