Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial.

BACKGROUND: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. OBJECTIVE: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. METHODS: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. RESULTS: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33% (26/79) of all adolescents were Black, 57% (45/79) were male, and 61% (48/79) had a household income of

A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

OBJECTIVE: Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. MATERIALS AND METHODS: A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. RESULTS: A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). DISCUSSION: Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. CONCLUSION: New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials.

Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

INTRODUCTION: Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. MATERIALS/METHODS: Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. RESULTS: Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. CONCLUSIONS: This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

Audio-video recording of health care encounters for pediatric chronic conditions: observational reactivity and its correlates.

OBJECTIVES: Audio-video recording of pediatric clinic visits could generate observational reactivity, affecting measures of communication among patients, parents, and clinicians. METHODS: We measured observational reactivity in a direct observation study of communication during 155 pediatric visits for any of 5 chronic conditions by coding camcorder awareness behaviors and self-report questionnaires. We analyzed associations between observational reactivity and measures of communication behavior and visit quality. RESULTS: Directly observed camcorder awareness behaviors (634 events) comprised 0.59% of all coded events (n = 107,668). Younger children displayed these behaviors more often than did older children (F = 6.47; p < .0001). Clinicians' camcorder awareness declined significantly over successive study visits (t = -2.096; p = .043). Associations of camcorder awareness with objectively scored communication behaviors or self-reported visit quality were negligible. CONCLUSIONS: Most recordings included slight evidence of participant camcorder awareness. But there was negligible evidence that camcorder awareness influenced clinic visit communication.

Validation of a self-report version of the diabetes self-management profile.

Inadequate treatment adherence impedes achievement of glycemic control targets in type 1 diabetes (T1D). Valid and reliable measurement of treatment adherence is a prerequisite to rigorous evaluation of pertinent interventions. The diabetes self-management profile (DSMP), a structured interview measure of T1D adherence, is valid and reliable but it requires trained interviewers, it is labor intensive to administer and it is burdensome for research participants. We adapted the DSMP interview to create the DSMP-self-report questionnaire (DSMP-SR) for completion by parents and youth ≥11 yr old. The DSMP-SR was obtained during a cross-sectional study of 151 youth within the age range of 8 to <18 yr with T1D [male, 50.7%; racial minorities, 23%; mean age, 13.9 yr; T1D duration, 5.5 yr; hemoglobin A1c (HbA1c), 8.7%] and a parent of each. Parents and youth ≥11 yr old completed the DSMP-SR independently. The DSMP-SR had sound internal consistency (Cronbach's α: youth, 0.82; parent, 0.80), and parent-youth agreement, (r = 0.60, p < 0.001) and significant associations with HbA1c (r = -0.35 for youth and -0.46 for parents, p < 0.001), PedsQL quality of life scale (youth: r = -0.41, p < 0.001; parent: r = -0.40, p < 0.001) and, for parents but not youth, the Revised Diabetes Family Conflict Scale (r = -0.47, p < 0.001). Higher DSMP-SR scores were associated with lower HbA1c, better quality of life, and less family conflict. The DSMP-SR has similar psychometric properties to those reported elsewhere for the DSMP, yielding a convenient measure of T1D adherence.

Youth and parent knowledge and communication about major complications of type 1 diabetes: associations with diabetes outcomes.

OBJECTIVE: Previously, we studied clinicians' and parents' perspectives about what, when, and how youth with type 1 diabetes (T1D) and parents should be taught about major complications (MC) of T1D. Results showed that this topic creates considerable anxiety among youth and parents, that there is a perceived need to tailor these experiences to each patient's circumstances, and that there is considerable variability in opinions about appropriate MC education. Prior studies did not measure youths' or parents' actual knowledge of complications, how they cope with that knowledge, or how these variables relate to T1D outcomes. The current study addresses these gaps. RESEARCH DESIGN AND METHODS: This article reports a cross-sectional study of 151 8- to 18-year-old youths with T1D and their parents in which their knowledge of MC (nephropathy, retinopathy, neuropathy, and cardiovascular disease) was ascertained by structured interview. Family communication about MC was assessed using a questionnaire validated in this study. Regression analyses explored youth age, parent and youth MC knowledge, and positive family communication about MC as predictors of T1D outcomes (hemoglobin A(1c), treatment adherence, quality of life, and family conflict about T1D). RESULTS: Parental MC knowledge was not associated with any T1D outcome; greater youth MC knowledge predicted better treatment adherence. More frequent optimistic family communication about MC was associated with more favorable status on all outcomes. CONCLUSIONS: Optimistic family communication about MC, more so than MC knowledge, predicted favorable T1D outcomes. Longitudinal studies are needed to confirm these associations and to evaluate pertinent psychoeducational interventions.

Parent report and direct observation of injection-related coping behaviors in youth with type 1 diabetes.

OBJECTIVE: This study evaluated insulin injection coping by parental report and video observation in children 3 to <11 years old with diabetes. METHODS: Caregivers of 61 youth with type 1 diabetes completed the Diabetes Injection Distress-Parent Report Form (DID-PRF); a subsample (n = 19; 30%) submitted video recordings of their children's insulin injections. RESULTS: The DID-PRF demonstrated acceptable internal consistency and moderately correlated with video recordings. Half of parents (n = 31; 51%) reported their child's history of insulin injection distress; 30% reportedly experienced distress ≥1 year after diagnosis. Current distress was reported for about half (n = 28) of children. More parent and child coping/distress behaviors was associated with younger child age. Children displayed more injection distress in their first month after diagnosis versus the most recent month. CONCLUSIONS: Diabetes-related injection distress and associated coping behaviors should be further explored; longitudinal data and additional measurement development is warranted.

Youth and parent education about diabetes complications: health professional survey.

OBJECTIVE: Avoiding complications is paramount in diabetes management, but little is known about how, when, and what diabetes professionals disclose to parents and youths about this topic. RESEARCH DESIGN AND METHOD: Pediatric diabetes experts (n = 534) were surveyed about their practices and attitudes regarding informing parents and youth about long-term diabetic complications. RESULTS: Professionals reported giving more information to parents, older children, and children with longer diabetes duration than younger or newly diagnosed children. Principal components analysis was completed to identify measurement factors of the attitudes about information sharing and variables affecting decision-making sections of the survey. These factor scores served as predictor variables in hierarchical multiple regression analyses. More information sharing was associated with more diabetes clinical activity, stronger sense of professional responsibility to disclose this information, less sensitivity about the emotional impact of this teaching, greater concern about exposure to inaccurate information, and less consideration of the family context (R(2) = 0.282, p < or = 0.0001). Greater propensity to share information about complications was found among health care providers who reported that they gave less consideration to such variables as the family's prior experience with diabetes in other family members or the child's duration of diabetes or the presence of psychiatric disorders in the child or family members. CONCLUSIONS: Patient characteristics and professionals' attitudes were associated with experts' willingness to inform families about long-term diabetic complications. Further research should explore how these practice variations affect coping with diabetes.

Diabetes complications in youth: qualitative analysis of parents' perspectives of family learning and knowledge.

OBJECTIVE: Youth with type 1 diabetes face long-term risks of health complications of the disease. Little is known about patients' and parents' knowledge, acquisition of information, and family communication regarding these complications. This paper reports qualitative analyses of parental focus-group discussions of this topic. RESEARCH DESIGN AND METHODS: A total of 47 participants (30 mothers, 14 fathers, and 3 others) representing 33 children between the ages of 8 and 18 years with type 1 diabetes participated in 1 of 13 focus groups. Open-ended questions focused on the type and amount of information about long-term complications presented to parents by health care professionals at different time points, as well as the way that information was presented. Questions also elicited details about parent-child communication and exposure to misconceptions about diabetes complications. RESULTS: Qualitative analysis of the transcribed focus groups revealed that participants experienced significant anxiety about diabetes complications, with a shift from concern about daily management tasks to concern about long-term complications over time. Participants desired a flexible, collaborative educational approach, especially regarding the timing and type of information, relative to the child's age and duration of diabetes. Many parents wanted more sensitive communication and emotional support from health care providers. Motivating children appeared to be a particular challenge; family burnout with regard to diabetes care over time was reported. Knowledge was gained in many ways, yet misinformation was uncommon. CONCLUSIONS: Obtaining information about long-term complications is an important process that changes over the course of the disease and with the child's developmental level. More research is needed, especially regarding youth knowledge, learning, and beliefs about diabetes complications.

The psychologic context of pediatric diabetes.

During the past few decades, there has been an explosion of behavioral science research on family management of pediatric diabetes. This article distills the major conclusions from that literature, emphasizing how primary care providers can apply these findings in clinical practice.

Psychological impact of writing about abuse or positive experiences.

Writing often helps people deal with trauma. To see if writing about childhood physical or sexual abuse, or positive experiences, helps, psychology undergraduates wrote for 20 minutes on 4 days about their abuse, a positive experience, or a trivial topic. Among 102 who began and 85 who completed pre-, post-, and 4-week follow-up measures of depression, anxiety, and suicidal ideas, abuse writers were more likely to discontinue, and positive writers were more depressed and anxious. Compared to pretest, all completers were less depressed, anxious, and suicidal at follow-up, but nonsignificantly different in health visits. Completers who wrote about abuse rated the study as more valuable than did those who wrote about positive experiences. College students who wrote about childhood physical or sexual abuse benefited from any type of structured writing assignment (where they interacted with a researcher and got extra credit) in terms of reduced anxiety, depression, and suicidal ideas, but they found value in writing about their trauma more than writing about innocuous topics.