Developing a simplified consent form for biobanking.

BACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

Communication practices in physician decision-making for an unstable critically ill patient with end-stage cancer.

BACKGROUND: Shared decision-making has become the standard of care for most medical treatments. However, little is known about physician communication practices in the decision making for unstable critically ill patients with known end-stage disease. OBJECTIVE: To describe communication practices of physicians making treatment decisions for unstable critically ill patients with end-stage cancer, using the framework of shared decision-making. DESIGN: Analysis of audiotaped encounters between physicians and a standardized patient, in a high-fidelity simulation scenario, to identify best practice communication behaviors. The simulation depicted a 78-year-old man with metastatic gastric cancer, life-threatening hypoxia, and stable preferences to avoid intensive care unit (ICU) admission and intubation. Blinded coders assessed the encounters for verbal communication behaviors associated with handling emotions and discussion of end-of-life goals. We calculated a score for skill at handling emotions (0-6) and at discussing end of life goals (0-16). SUBJECTS: Twenty-seven hospital-based physicians. RESULTS: Independent variables included physician demographics and communication behaviors. We used treatment decisions (ICU admission and initiation of palliation) as a proxy for accurate identification of patient preferences. Eight physicians admitted the patient to the ICU, and 16 initiated palliation. Physicians varied, but on average demonstrated low skill at handling emotions (mean, 0.7) and moderate skill at discussing end-of-life goals (mean, 7.4). We found that skill at discussing end-of-life goals was associated with initiation of palliation (p = 0.04). CONCLUSIONS: It is possible to analyze the decision making of physicians managing unstable critically ill patients with end-stage cancer using the framework of shared decision-making.

Structuring the Calibration of Qualitative Data as Sets for Qualitative Comparative Analysis (QCA)

Most studies that apply qualitative comparative analysis (QCA) rely on macro-level data, but an increasing number of studies focus on units of analysis at the micro or meso level (i.e., households, firms, protected areas, communities, or local governments). For such studies, qualitative interview data are often the primary source of information. Yet, so far no procedure is available describing how to calibrate qualitative data as fuzzy sets. The authors propose a technique to do so and illustrate it using examples from a study of Guatemalan local governments. By spelling out the details of this important analytic step, the authors aim at contributing to the growing literature on best practice in QCA. © The Author(s) 2012.

Physical activity-related and weather-related practices of child care centers from 2 states

© 2015 Human Kinetics, Inc.Background: Young children's physical activity (PA) is influenced by their child care environment. This study assessed PA practices in centers from Massachusetts (MA) and Rhode Island (RI), compared them to best practice recommendations, and assessed differences between states and center profit status. We also assessed weather-related practices. Methods: Sixty percent of MA and 54% of RI directors returned a survey, for a total of 254. Recommendations were 1) daily outdoor play, 2) providing outdoor play area, 3) limiting fixed play structures, 4) variety of portable play equipment, and 5) providing indoor play area. We fit multivariable linear regression models to examine adjusted associations between state, profit status, PA, and weather-related practices. Results: MA did not differ from RI in meeting PA recommendations (β = 0.03; 0.15, 0.21; P = .72), but MA centers scored higher on weather-related practices (β = 0.47; 0.16, 0.79; P = .004). For-profit centers had lower PA scores compared with nonprofits (β = -0.20; 95% CI: -0.38, -0.02; P = .03), but they did not differ for weather (β = 0.12; -0.19, 0.44; P = .44). Conclusions: More MA centers allowed children outside in light rain or snow. For-profit centers had more equipment-both fixed and portable. Results from this study may help inform interventions to increase PA in children.