Publishing pragmatic trials.

BACKGROUND: Pragmatic clinical trials (PCTs) are an important research approach for nurse researchers seeking to bring efficacious interventions to the real world of clinical practice. These approaches take into account the complex and often messy conditions of clinical care, involving patients with comorbid conditions, many providers providing the intervention, and limited evaluation data with which to judge effectiveness. PURPOSE: The purposes of this paper are to describe the challenges for PCT manuscript writer and to review the various guidelines that may be used to assist in manuscript development. DISCUSSION: Describing the design and results of a PCT in a manuscript for publication is challenging due to the complexity and unique context of these important trials. Guidelines and other resources are available to assist researchers in preparing manuscripts reporting PCTs.

Balancing Eating With Breathing: Community-Dwelling Older Adults' Experiences of Dysphagia and Texture-Modified Diets.

Purpose: Although many older adults suffer from dysphagia and are required to eat texture-modified diets, little is known about the experiences and challenges faced in doing so at home. In this study, we explored the perspectives of community-dwelling older adults as they struggled to balance dysphagia symptoms and recommended diet modifications with their preferred lifestyles. Design and Methods: Using an interpretive descriptive design, we conducted 37 in-home semi-structured interviews and 5 member-checking interviews, participant observations during a meal, and reviewed the medical charts of 20 participants recruited through maximum variation purposeful sampling. Meaning units and codes were identified and synthesized into 4 themes. Results: Participants faced a frightening choice between eating and breathing. Hiding dysphagia symptoms from the public eye was important to preserve self-identity. Following the recommended diet created a feeling that life was "falling apart." We also found that adhering to the diet was not an "all or none" phenomenon. Implications: Given that correct adherence to the restrictive diet is rare, to effectively manage dysphagia symptoms, clinicians must appreciate the full range of impact of dysphagia and texture-modified diets on the lives of older adults.

Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial.

HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from five community organizations were randomized to self-administered web-based assent (n=60) or investigator-administered paper assent with (n=29) or without (n=31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118=-0.08, p=0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58=1.96, p=0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation.