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.

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.

Underserved women in a women's health clinic describe their experiences of depressive symptoms and why they have low uptake of psychotherapy.

Low-income and African American patients in women's health clinics are at risk for depression and under-treatment of their depression. This study aimed to understand women's health patients' experiences of depressive symptoms and perspectives on the low uptake of psychotherapy. Twenty-three women with depressive symptoms from a women's health clinic completed individual qualitative interviews. Women reported risk of harm in the therapeutic relationship as the primary barrier; physical and mental health symptoms and doubt that psychotherapy will help were also described. Women also reported psychotherapy can be helpful by allowing women to express their feelings, gain insight, and make life changes.

Internet use by parents of infants with positive newborn screens.

BACKGROUND: Internet searches on health topics are common, but not enough is known about online use during serious health concerns. The aim of this study was to investigate parents' internet use and responses to online information following the referral of their newborn screen-positive infants. METHODS: Forty-four parents were interviewed about their internet use during their infants' evaluations for a potential metabolic disorder. Responses to open-ended questions were audio taped and transcribed. Content analysis was used in analyzing the interview data. RESULTS: An overwhelming majority of parents (89%) accessed the internet and most went online before meeting with genetic providers at metabolic treatment centers. Primary and genetic providers did not routinely recommend websites to parents. Online descriptions of metabolic disorders increased parents' anxieties. Some parents allayed their distress by enlisting others to search and filter information for them and by seeking optimistic internet content about the disorders. Parents with fewer years of education were often baffled by complex disease information. Parents found limited information about treatments or what to expect during the clinical evaluations of their infants. CONCLUSIONS: The internet is an integral part of health care and an important source of information for newborn screening parents. Parents may benefit from recommendations of credible websites and discussions of internet information with health care providers.

Always, never, or sometimes: examining variation in condom-use decision making among Black adolescent mothers.

Our purpose in this study was to describe Black adolescent mothers' decisions regarding condom use and non-use with their male sex partners, including their children's fathers. Research on partner type and condom use has been insufficiently focused on understanding the specific influence that the biological father of the baby has on condom use among adolescent mothers. We conducted five focus groups and three interviews with 31 predominantly African-American mothers. We found that their decisions to use condoms always, never, or sometimes were based on partner type and on emotional and relationship factors. The "baby daddy" was the only partner with whom they never used condoms. HIV/STI prevention interventions for adolescent mothers must address risk taking with their children's biological fathers.

Sexual Partner Type Taxonomy Use Among Black Adolescent Mothers in the United States.

PURPOSE: Research on sexual-partner type focuses mostly on "main" and "casual" partner categories. The literature indicates that adolescent girls are less likely to use condoms with main partners, and more likely to use condoms with casual partners. Adolescent mothers may have different types of sexual partners than other adolescent girls. The purpose of this study was to explore and describe the range of male sexual partner types reported by Black adolescent mothers. DESIGN AND SAMPLE: This study was a qualitative description of the perspectives of Black, predominantly African-American, mothers (n=31). Data were generated using focus groups and interviews. The participants' ages ranged from 15-19 years. MEASURES: A semi-structured qualitative questioning guide was used to stimulate focused discussions. Transcribed data were analyzed using qualitative content analysis. RESULTS: The range of sexual partner types of the women were reflected in three themes (1) All main partners are not created equal; (2) They're not casual partners because there are strings attached; (3) "Wham, bam, thank you ma'am:" No strings attached. Nine partner types were identified under these three themes, including a "baby daddy" partner. CONCLUSION: The partner-types of Black adolescent mothers are more robust than the "main" and "casual" partner categories typically referenced in the research literature. The range of sex partners includes the birth fathers of their children. Clinicians and researchers must consider how co-parenthood status is used in the construction of the "baby daddy" partner and what implications this unique sexual partner type may have on risk reduction behaviors such as condom use.