Key Study Variables Research Articles

Editorial: Scientific Reporting: How to Focus the “Good Ole Boy Paper”

Editorial: Scientific Reporting: How to Focus the “Good Ole Boy Paper”

Effects of an Adolescent Asthma Education Intervention on Knowledge, Intention, Behavior, Self-Efficacy and Self-Consciousness

In this study, we evaluated the effects of an asthma education intervention, guided by social cognitive theory, on knowledge, intention, behavior, self-efficacy, and self-consciousness. The sample consisted of 87 asthmatic adolescents in six middle and/or high schools in California. A non-equivalent comparison group design, with delayed intervention in the comparison group, was utilized. We implemented a modified version of the American Lung Association’s Kickin Asthma curriculum. Self-report questionnaires assessing the key study variables were administered at baseline, at immediate postintervention, and five weeks after the intervention. There were no statistically significant differences at post-test, controlling for pre-test values, for any of the study variables between the intervention (n = 51) and comparison groups (n = 35). After collapsing across groups, however, there were statistically significant improvements following the intervention for knowledge, intention, selected behavior variables, and self-efficacy. The evaluation of this theory-based asthma education intervention demonstrates the positive impact this curriculum can have on a sample of asthmatic adolescents.

Abstract A33: Culturally relevant cancer risk counseling for underserved Latinas

Abstract Background: Latinas are as likely as the majority to have high cancer risk associated with genetic predisposition to breast cancer and ovarian cancer. Disproportionately underserved, Latinas have a compelling need for access to genetic cancer risk assessment (GCRA) and cancer screening and prevention measures. Objectives: The primary purpose of this project was to evaluate the effects of a culturally relevant GCRA intervention for Latinas. Methods: Four focus groups were conducted consisting of Latinas that have undergone GCRA. Participants completed a demographic questionnaire that included items assessing perceived cancer risk and satisfaction with GCRA. The focus groups entailed a facilitated discussion of the key study variables and other culturally relevant issues that may impact the GCRA intervention. Descriptive statistics and thematic analysis were used. Results: Perceived sense of lack of information and uncertainty about what to expect appeared to play a key role in distress. Most women initially had negative expectations (expecting the worse or bad outcome), but ultimately felt hopeful that they could learn more about the GCRA process and what it meant for them. Information was cited as the primary contributor to positive psychosocial outcomes specifically increased locus of control and self-efficacy. The major cultural themes identified were destiny, religious and spiritual coping, how cultural attitudes and belief influence lack of information, community awareness, and public health issues. Conclusions: Findings indicate that the pre-GCRA window may be most distressing for this population indicating that this may be the most appropriate time for psychological intervention. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A33.

Rethinking Music Festivals as a Staged Event: Gaining Insights from Understanding Visitor Motivations and the Experiences They Seek

Event managers are increasingly under pressure to develop new strategies that will optimize any competitive advantages that their event may have, while, at the same time, minimizing their operation's vulnerability to external threats and emulation. Yet, for all this, little research has been done to date with respect to visitor engagement in events, such as music festivals, in the Australian setting. With this in mind, the principal aim of this study was to profile visitors who attended the Tamworth Country Music Festival to determine their main motivations for attendance and what aspects of the event have differentiated it from others of its type. Overall, over 1,500 visitor surveys were collected, with results showing that there was a significant difference among festival visitors with respect to their activity engagement, reasons for attending the festival, and assessment of it when comparisons across key study variables were determined. These findings provide clear insights into the changing nature of visitor engagement in the experience economy and the importance of servicing the diverse needs of discrete niche groups who might congregate at a particular event.

Validating the Posttraumatic Stress Disorder Symptom Scale With Persons Who Have Severe Mental Illnesses

Objective: Interview data collected from 275 clients with severe mental illnesses are used to test the construct and criterion validity of the Posttraumatic Stress Disorder Symptom Scale (PSS). Method: First, exploratory and confirmatory factor analyses are used to test whether the scale reflects the posttraumatic stress disorder (PTSD) symptom criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text rev. (DSM-IV-TR ). Second, structural equation modeling (SEM) is used to test concurrent validity. Results: A 2-factor PSS reveals an excellent fit to the data, and SEM shows good concurrent validity with key study variables. Conclusion: The PSS reveals a 2-factor structure (Re-experiencing and Avoidance) in this particular sample, and stress from high-risk behaviors and drinking to cope with negative emotions mediate the relationship between subjective distress from trauma and PTSD symptoms.

Payeeship, Financial Leverage, and the Client-Provider Relationship

Payeeship, Financial Leverage, and the Client-Provider Relationship

Diagnostic and Other Correlates of HIV Risk Behaviors in a Probability Sample of Homeless Adults

Diagnostic and Other Correlates of HIV Risk Behaviors in a Probability Sample of Homeless Adults

Relationship of Internet Health Information Use With Patient Behavior and Self-Efficacy: Experiences of Newly Diagnosed Cancer Patients Who Contact the National Cancer Institute's Cancer Information Service

ABSTRACT This study examines the relationship of Internet health information use with patient behavior and self-efficacy among 498 newly diagnosed cancer patients. Subjects were classified by types of Internet use: direct use (used Internet health information themselves), indirect use (used information accessed by friends or family), and non-use (never accessing Internet information). Subjects were recruited from callers of the National Cancer Institute's (NCI's) Cancer Information Service, Atlantic Region. They were classified by type of Internet use at enrollment and interviewed by telephone after 8 weeks. There were significant relationships among Internet use and key study variables: subject characteristics, patient task behavior, and self-efficacy. Subjects' Internet use changed significantly from enrollment to 8 week follow-up; 19% of nonusers and indirect users moved to a higher level of Internet use. Significant relationships also were found among Internet use and perceived patient–provider relationship, question asking, and treatment compliance. Finally, Internet use was also significantly associated with self-efficacy variables (confidence in actively participating in treatment decisions, asking physicians questions, and sharing feelings of concern). The results of this study show that patients who are newly diagnosed with cancer perceive the Internet as a powerful tool, both for acquiring information and for enhancing confidence to make informed decisions.

Assessing the Implementation of the Chronic Care Model in Quality Improvement Collaboratives

To measure organizations' implementation of Chronic Care Model (CCM) interventions for chronic care quality improvement (QI). Monthly reports submitted by 42 organizations participating in three QI collaboratives to improve care for congestive heart failure, diabetes, depression, and asthma, and telephone interviews with key informants in the organizations. We qualitatively analyzed the implementation activities of intervention organizations as part of a larger effectiveness evaluation of yearlong collaboratives. Key study variables included measures of implementation intensity (quantity and depth of implementation activities) as well as fidelity to the CCM. We developed a CCM-based scheme to code sites' intervention activities and criteria to rate their depth or likelihood of impact. The sites averaged more than 30 different change efforts each to implement the CCM. The depth ratings for these changes, however, were more modest, ranging from 17 percent to 76 percent of the highest rating possible. The participating organizations significantly differed in the intensity of their implementation efforts (p<.001 in both quantity and depth ratings). Fidelity to the CCM was high. Collaborative participants were able, with some important variation, to implement large numbers of diverse QI change strategies, with high CCM fidelity and modest depth of implementation. QI collaboratives are a useful method to foster change in real world settings.

Strategies for motivating Latino couples' participation in qualitative health research and their effects on sample construction.

Many investigators report difficulties recruiting low-income Latinos into health research projects, especially when they seek to enroll more than one family member. We developed a series of strategies that proved effective in motivating candidates who were initially reluctant to enroll. There is a possibility that these strategies biased the composition of the sample. Predictably, the reasons participants gave for enrolling were correlated with the recruitment strategy that had brought them into the study. Furthermore, we found statistically significant associations between recruitment technique and key study variables (e.g., the domestic stability of the couple). By increasing investigators' ability to recruit Latinos, however, the strategies outlined should help to ensure that Latinos' experiences are given due weight in the deliberations of medical professionals and policymakers.

Patterns of aspirin use before hospitalization for acute myocardial infarction

A has been available as an antipyretic for approximately 100 years, and it has been known to have antiplatelet activity for .30 years.1 During the 1980s, several well-controlled trials unequivocally established aspirin as an effective agent for primary and secondary prevention of cardiac events.2,3 Despite the available data, the use of aspirin in acute coronary syndromes is inappropriately low.4 We undertook a retrospective, 1-year analysis of the antecedent use of aspirin for primary prevention by patients presenting with a primary diagnosis of acute myocardial infarction (AMI). • • • We performed a retrospective chart review of the 291 patients admitted to Stanford University Medical Center from June 1, 1996, to May 30, 1997, with a primary diagnosis of AMI. Patients were defined as having had an AMI by creatine phosphokinase elevation .2 times the normal range with either consistent clinical history, pathologic Q waves, or dynamic electrocardiographic repolarization abnormalities. We included only patients who had sufficiently detailed information available to ascertain aspirin use and other key study variables. We tabulated established cardiac risk factors that included male gender, age .55 years for men, or .65 years for women, previously diagnosed diabetes mellitus or systemic hypertension, current or previous tobacco use .20 packyears, a family history of coronary disease diagnosed before age 50, hypercholesterolemia as defined by National Cholesterol Education Program guidelines, and absence of estrogen replacement therapy in postmenopausal women. Individual patient data were obtained from both the admitting cardiologist and house staff notes. The emergency room attending’s note was reviewed as the deciding factor if there were discrepancies between recorded history of both medication use and the presence or absence of a certain risk factor. Lack of specific mention of a risk factor in a detailed history was taken as that factor being absent. Out-of-hospital transfers for cardiac catheterization were included if there was a full dictated admission note from an attending cardiologist addressing all of the relevant data points. Exclusion criteria included patients admitted with a different primary diagnosis, in-hospital transfers from other services, and transferred patients with an inadequate history. Of the 291 patient charts meeting the criteria for AMI, 123 were found to have sufficiently detailed information regarding the key variables to be included in the study population. The clinical profile of these patients was similar to patients for whom inadequate information was available. The average age of included patients was 69 years, versus 70 years for excluded patients (p 5 NS). Sixty-six percent of included patients were men versus 70% for those excluded. However, the ratio of patients admitted through the emergency department to those transferred from other hospitals was significantly higher in the study population (2.45/1) than the admission ratio for excluded patients (1.04/1, p 5 0.006), reflecting more complete histories for direct admissions. Of the 123 patients with complete information, 33 (27%) were taking some form of aspirin at the time of their AMI. Of the patients who were taking aspirin, 82% took a dose of 325 mg/day. With the exception of those with specified aspirin allergy (,3%), all patients received aspirin on admission. The average creatine phosphokinase elevation in the study population was 1,593 IU, with 53 patients (43%) with AMIs defined as transmural. Ninety-seven of the 123 study patients (76%) had diagnostic catherization for further evaluation and treatment. The distribution of known risk factors for coronary disease among the study population is summarized in Table I, with systemic hypertension and hypercholesterolemia occurring most often. By quantitative risk factor assessment, there were essentially equivalent numbers of highand low-risk patients. Categorization of patients based on whether they had .3 or ,3 risk factors demonstrated no significant differential use of aspirin therapy. We hypothesized that the proportion of patients From Stanford University Medical Center, Stanford, California. Dr. Alderman’s address is: Stanford University Medical Center CVRC261, Stanford, California 94305. E-mail: alderman@leland. stanford.ed. Manuscript received October 13, 1999; revised manuscript received and accepted January 31, 2000. TABLE I Baseline Characteristics of Patients

Predictors of mortality from fires in young children.

In the United States in 1994, fires claimed 3.75 lives per 100 000 child years and accounted for 17.3% of all injury deaths in children <5 years of age. To conduct a historical cohort study that uses maternal demographic characteristics to identify young children at high risk of fire-related deaths, thus defining appropriate targets for prevention programs. The cohort consisted of children born to mothers who resided in the state of Tennessee between 1980 and 1995. Information was obtained by linking birth certificates, 1990 census data, and death certificates. Children were eligible for the study if they were <5 years of age at any time within the study period and if key study variables were present (99.2% of births). Birth certificates provided information on maternal characteristics including age, race, education, previous live births, use of prenatal care, and residence (in standard metropolitan statistical area). Child characteristics included gender, gestational age, and birth type (singleton/multiple gestation). Neighborhood income was estimated by linking the mother's address at the time of birth to the 1990 census (block group mean per capita income). The study outcome was a fire resulting in at least one fatality (fatal fire event) during the study period, identified from death certificates (coded E880 through E889 in the International Classification of Diseases, 9th rev). We calculated the fatal fire event rate corresponding to each stratum of maternal/child characteristics. We assessed the independent association between each characteristic and the risk of a fatal fire event from a Poisson regression multivariate analysis. During the study period, 1 428 694 children contributed 5 415 213 child years to the cohort: there were 270 deaths from fire (4.99 deaths per 100 000 child years) and 231 fatal fire events. In the multivariate analysis, factors associated with greater than a threefold increase in fatal fire events included maternal education, age, and number of other children. Compared with children whose mothers had a college education, children whose mothers had less than a high school education had 19.4 times (95% confidence interval [CI], 2.6-142.4) an increased risk of a fatal fire event. Children whose mothers had more than two other children had 6.1 times (95% CI, 3.8-9.8) an increased risk of a fatal fire event compared with children whose mothers had no other children. Children of mothers <20 years of age had 3.9 times (95% CI, 2.2-7.1) increased risk of a fatal fire event compared with children whose mothers were >/=30 years old. Although both maternal neighborhood income and race were associated strongly with increased rates of fatal fire events in the univariate analysis, this association did not persist in the multivariate analysis. Other factors that were associated with increased risk of fatal fire events in the multivariate analysis were male gender and having a mother who was unmarried or who had delayed prenatal care. The three factors associated most strongly with fire mortality were combined to create a risk score based on maternal education (>/=16 years, 0 points; 13 to 15 years, 1 point; 12 years, 2 points; <12 years, 3 points); age (>/=30 years, 0 points; 25 to 29 years, 1 point; 20 to 24 years, 2 points; <20 years, 3 points); and number of other children (none, 0 points; one, 1 point; two, 2 points; three or more, 3 points). The lowest-risk group (score <3) included 19% of the population and had 0.19 fatal fire events per 100 000 child years. In contrast, highest-risk children (score >7) comprised 1.5% of the population and had 28.6 fatal fire events per 100 000 child years, 150 times higher than low-risk children. Children with risk scores >5 contributed 26% of child years but experienced 68% of all fatal fire events. If the fatal fire event rate for all children had been equal to that of the low-risk group (risk score <3), then 95% of deaths from

A Statistically-Based Process for Auditing Clinical Data Listings

In October 1995, members of the DuPont Merck Biometrics and Quality Assurance staffs met to discuss improvements in the audit process for clinical data listings. With the advent of the International Conference on Harmonization (ICH) good clinical practices (GCPs), they were concerned about assuring that the procedures and processes for managing incoming clinical data and reporting to regulatory agencies were appropriately rigorous to ensure complete and accurate processing of clinical trial data. The following article describes a statistically-based audit plan that takes into consideration the phase of the trial, the importance of the trial to regulatory filings, and key study variables. The audit plan also includes a procedure for randomly selecting studies and patients for audit, and establishes statistically-based acceptance and rejection criteria. This audit process has been in use for six months and has resulted in more efficient planning and execution of clinical data audits. Due to the randomness of the process and high standards for acceptable quality levels (AQL), internal quality control (QC) procedures have been strengthened to assure that all data listings meet these standards.

Head Over Heels: Impact of a Health Promotion Program to Reduce Falls in the Elderly

RÉSUMÉLe projet FIT – Falls Intervention Trials (étude sur les essais d'intervention après les chutes) – consistait en une étude clinique avec répartition aléatoire des effets d'un programme visant à réduire l'incidence de chutes et leurs séquelles chez les personnes âgées. L'échantillon se composait de 100 personnes de 60 ans et plus, vivant dans la région de la capitale provinciale (Victoria, C.-B.) et ayant fait une chute au cours des trois mois précédant l'étude. L'intervention prenait la forme d'une évaluation détaillée des risques, de commentaires individuels quant aux risques déterminés, ainsi qu'une bande vidéo accompagnée d'une brochure d'information intitulées Head over Heels. La mesure des résultats comprenait l'incidence des chutes, l'auto-efficacité en cas de chutes, la crainte de chuter, le fonctionnement social, l'utilisation des services de santé et la qualité de vie. Bien que les principales variables de l'étude n'aient révélé aucune différence statistique importante entre le groupe expérimental et le groupe témoin, on a pu constater une amélioration au sein des deux groupes entre le début de l'étude et l'évaluation de suivi, six mois après sa conclusion. L'article traite des différentes raisons possibles expliquant ces résultats et leurs conséquences en fonction de recherches plus approfondies.

The relationship between social support and maternal behaviors and attitudes: A meta‐analytic review

Used meta-analysis to analyze 66 studies that evaluated the relationship between social support available to the mother and maternal behaviors and attitudes. Investigators sampled relatively homogeneous populations of white, middle-class, married mothers of young children without physical or mental disabilities. A variety of instruments were used to assess key study variables. Significant correlations existed between both emotional and material support and maternal behaviors. Implications of these findings for funding of family support programs and for professionals working with mothers are discussed.