Inclusion of Effect Size Measures and Clinical Relevance in Research Papers.

BACKGROUND: There are multiple issues that arise when researchers focus on and only report "statistical significance" of study findings. An important element that is often not included in reports is a discussion of clinical relevance. OBJECTIVES: The authors address issues related to significance, the use of effect sizes, confidence or credible intervals, and the inclusion of clinical relevance in reports of research findings. METHODS: Measures of magnitude, precision, and relevance such as effect sizes, confidence intervals (CIs), and clinically relevant effects are described in detail. In addition, recommendations for reporting and evaluating effect sizes and CIs are included. Example scenarios are presented to illustrate the interplay of statistical significance and clinical relevance. RESULTS: There are several issues that may arise when significance is the focus of clinical research reporting. One issue is the lack of attention to nonsignificant findings in published works although findings show clinical relevance. Another issue is that significance is interpreted as clinical relevance. As well, clinically relevant results from small-sample studies are often not considered for publication, and thus, findings might not be available for meta-analysis. DISCUSSION: Findings in research reports should address effect sizes and clinical relevance and significance. Failure to publish clinically relevant effects and CIs may preclude the inclusion of clinically relevant studies in systematic reviews and meta-analyses, thereby limiting the advancement of evidence-based practice. Several accessible resources for researchers to generate, report, and evaluate measures of magnitude, precision, and relevance are included in this article.

Occupational stress, job satisfaction and job performance among hospital nurses in Kampala, Uganda.

AIMS: To assess levels of occupational stress, job satisfaction and job performance among hospital nurses in Kampala, Uganda; and how they are influenced by work and personal characteristics. BACKGROUND: Occupational stress is reported to affect job satisfaction and job performance among nurses, thus compromising nursing care and placing patients' lives at risk. Although these factors have been studied extensively in the US and Europe, there was a need to explore them from the Ugandan perspective. METHODS: A correlational study was conducted with 333 nurses from four hospitals in Kampala, Uganda. A questionnaire measuring occupational stress, job satisfaction and job performance was used. Data were analysed using descriptive statistics and anova. RESULTS: There were significant differences in levels of occupational stress, job satisfaction and job performance between public and private not-for-profit hospitals, nursing experience and number of children. CONCLUSIONS: Organizational differences between public and private not-for-profit hospitals influence the study variables. IMPLICATIONS FOR NURSING MANAGEMENT: On-the-job training for nurse managers in human resource management to increase understanding and advocacy for organizational support policies was recommended. Research to identify organizational, family or social factors which contribute to reduction of perceived occupational stress and increase job satisfaction and job performance was recommended.

Perioperative music and its effects on anxiety, hemodynamics, and pain in women undergoing mastectomy.

There is increasing interest in evaluating the use of nonpharmacologic interventions such as music to minimize potential adverse effects of anxiety-reducing medications. This study used a quasi-experimental design to evaluate the effects of a perioperative music intervention (provided continuously throughout the preoperative, intraoperative, and postoperative periods) on changes in mean arterial pressure (MAP), heart rate, anxiety, and pain in women with a diagnosis of breast cancer undergoing mastectomy. A total of 30 women were assigned randomly to a control group or to the music intervention group. Findings indicated that women in the intervention group had a greater decrease in MAP and anxiety with less pain from the preoperative period to the time of discharge from the recovery room compared with women in the control group. Music is a noninvasive and low-cost intervention that can be easily implemented in the perioperative setting, and these findings suggest that perioperative music can reduce MAP, anxiety, and pain among women undergoing mastectomy for breast cancer.

Research coordinators' experiences with scientific misconduct and research integrity.

BACKGROUND: Most reports of scientific misconduct have been focused on principal investigators and other scientists (e.g., biostatisticians) involved in the research enterprise. However, by virtue of their position, research coordinators are often closest to the research field where much of misconduct occurs. OBJECTIVE: The purpose of this study was to describe research coordinators' experiences with scientific misconduct in their clinical environment. DESIGN: The descriptive design was embedded in a larger cross-sectional national survey. A total of 266 respondents, predominately registered nurses, who answered "yes" to having firsthand knowledge of scientific misconduct in the past year, provided open-ended question responses. METHODS: Content analysis was conducted by the research team, ensuring agreement of core categories and subcategories of misconduct. FINDINGS: Research coordinators most commonly learned about misconduct via firsthand witness of the event, with the principal investigator being the person most commonly identified as the responsible party. Five major categories of misconduct were identified: protocol violations, consent violations, fabrication, falsification, and financial conflict of interest. In 70% of cases, the misconduct was reported. In most instances where misconduct was reported, some action was taken. However, in approximately 14% of cases, no action or investigation ensued; in 6.5% of cases, the coordinator was fired or he or she resigned. CONCLUSIONS: This study demonstrates the need to expand definitions of scientific misconduct beyond fabrication, falsification, and plagiarism to include other practices. The importance of the ethical climate in the institution in ensuring a safe environment to report and an environment where evidence is reviewed cannot be overlooked.

Depressive Symptoms, Perceived Stress, and Cortisol in School-Age Children With Type 1 Diabetes: A Pilot Study.

Despite adequate insulin regimens and concurrent treatments for Type 1 diabetes (T1D), many children have trouble achieving glycemic control, as evidenced by elevated HbA1c levels. Maternal and child depressive symptoms, as well as child perceived stress, are associated with less optimal glycemic control. Cortisol, a stress hormone, may mediate the relationships among depressive symptoms, perceived stress, and glycemic control. The purposes of this pilot study were to (1) examine the feasibility of collecting salivary samples to measure cortisol change in prepubertal school-age children diagnosed with T1D and (2) determine effect sizes for the relationships among maternal depressive symptoms and child depressive symptoms, perceived stress, cortisol levels, and glycemic control. Participants were recruited using convenience sampling from a pediatric endocrinology clinic in the southeastern United States. All data, including surveys, salivary samples, HbA1c, height, and weight, were collected the same day as a clinic visit. The study included 30 children, ages 6.9-12.2 years, and their mothers. Most children were female (70%) and Caucasian (76.7%), but the sample was socioeconomically diverse. HbA1c values ranged from 6.1% to 12.2%. Of the children, 18 showed normal declines in cortisol over 3 hr, while 12 had increases in cortisol. Results show recruitment, participation, and data collection are feasible in school-age children with T1D. Examination of relevancy thresholds for effect sizes between variables of interest supports the need for future research in a larger, more representative sample on research questions that include the role cortisol plays as a potential mediator among examined variables.

Geographic access to interventional cardiology services in one rural state.

OBJECTIVES: Explore (1) the characteristics of the Maine population with delayed geographic access to interventional cardiology (IC) services and (2) the effect of delayed geographic IC access on coronary mortality. BACKGROUND: Acute coronary syndrome (ACS), ST-segment elevated myocardial infarction (STEMI), and non-ST segment elevated myocardial infarction (NSTEMI) are highly prevalent. Coronary mortality is minimized when victims have prompt IC access. METHODS: The study design was (1) an exploration of census data to investigate disparities in geographic IC access and (2) a secondary analysis of administrative claims data to investigate coronary mortality relative to delayed geographic IC access. RESULTS: Delayed access was associated in the Maine population with rural residence, advanced age, high school education, and lack of health insurance. Delayed access was associated with increased unadjusted coronary mortality, but not age-adjusted coronary mortality. CONCLUSION: Delayed geographic IC access was associated with disparity but not with increased age-adjusted coronary mortality.

Predicting depressive symptoms and self-care in patients with heart failure.

OBJECTIVE: To examine relationships among heart failure (HF) physical symptoms, social support, social problem-solving, depressive symptoms, and self-care behaviors in outpatients with HF. METHODS: Cross-sectional data were collected from 201 outpatients. Structural equation modeling was used in this preliminary analysis to examine the relationships among the study variables. RESULTS: HF physical symptoms and social support were predictors of depressive symptoms and self-care behaviors. Social problem-solving also predicted self-care behaviors. Social support mediated the relationship between HF physical symptoms and depressive symptoms. CONCLUSIONS: Social support may influence depressive symptoms and self-care behaviors, whereas social problem-solving may impact self-care behaviors. Future research should examine causality and sub-components of social problem-solving on these outcome variables.

Effectiveness of regionalized systems for stroke and myocardial infarction.

BACKGROUND: Acute ischemic stroke (AIS) and ST-segment elevation myocardial infarction (STEMI) are ischemic emergencies. Guidelines recommend care delivery within formally regionalized systems of care at designated centers, with bypass of nearby centers of lesser or no designation. We review the evidence of the effectiveness of regionalized systems in AIS and STEMI. METHODS: Literature was searched using terms corresponding to designation of AIS and STEMI systems and from 2010 to the present. Inclusion criteria included report of an outcome on any dependent variable mentioned in the rationale for regionalization in the guidelines and an independent variable comparing care to a non- or pre-regionalized system. Designation was defined in the AIS case as certification by the Joint Commission as either a primary (PSC) or comprehensive (CSC) stroke center. In the STEMI case, the search was conducted linking "regionalization" and "myocardial infarction" or citation as a model system by any American Heart Association statement. RESULTS: For AIS, 17 publications met these criteria and were selected for review. In the STEMI case, four publications met these criteria; the search was therefore expanded by relaxing the criteria to include any historical or anecdotal comparison to a pre- or nonregionalized state. The final yield was nine papers from six systems. CONCLUSION: Although regionalized care results in enhanced process and reduced unadjusted rates of disparity in access and adverse outcomes, these differences tend to become nonsignificant when adjusted for delayed presentation and hospital arrival by means other than emergency medical services. The benefits of regionalized care occur along with a temporal trend of improvement due to uptake of quality initiatives and guideline recommendations by all systems regardless of designation. Further research is justified with a randomized registry or cluster randomized design to support or refute recommendations that regionalization should be the standard of care.

Factors associated with depressive symptoms in patients with heart failure.

Home healthcare clinicians commonly provide care for individuals with heart failure (HF). Certain factors may influence the development of depressive symptoms in those with HF. This cross-sectional, descriptive, correlational pilot study (N = 50) examined interrelationships among HF symptoms, social support (actual and perceived), social problem-solving, and depressive symptoms. Findings indicated that increased HF symptoms were related to more depressive symptoms, whereas higher levels of social support were related to fewer depressive symptoms. The use of more maladaptive problem-solving strategies was also associated with more depressive symptoms. Study results have implications for home healthcare clinicians providing care for individuals with HF, indicating a need for programs that strengthen coping skills and resources (i.e., social support and problem solving) in an effort to decrease the risk of developing depressive symptomatology.

Effect of an educational intervention on cardiovascular disease risk perception among women with preeclampsia.

OBJECTIVE: To promote knowledge and awareness about cardiovascular disease (CVD) among women with recent preeclampsia so that this population may develop more accurate perceptions of their personal CVD risk. DESIGN: An exploratory single group, pretest/posttest educational intervention study. SETTING: Telephone-based interviews. PARTICIPANTS: Sixty-four women with preeclampsia in the most recent pregnancy completed the study. The sample was predominately African American. METHODS: Knowledge about CVD and the study covariates (age, race, parity, income, marital status, education, and history of previous preeclampsia) were measured prior to CVD education. Levels of CVD risk perception were measured both before and after the CVD educational intervention. INTERVENTION: Structured CVD education by telephone. RESULTS: After CVD education, levels of CVD risk perception were significantly higher than at baseline. CONCLUSION: As an intervention, CVD education provided by telephone served as a practical and effective approach to contact postpartum women with recent preeclampsia and demonstrated effectiveness in increasing perception of CVD risk.

Relationship of blood pressure self-monitoring, medication adherence, self-efficacy, stage of change, and blood pressure control among municipal workers with hypertension.

Uncontrolled blood pressure remains a major public health issue. Medication adherence is a key factor in blood pressure management; however, adherence behavior is not clearly understood and the most significant factors contributing to poor medication adherence and blood pressure control are unknown. The purpose of this study was to determine the relationship of self-monitoring of blood pressure, medication adherence, self-efficacy, stage of change, and blood pressure control among municipal workers with access to health insurance. Stage of change was a significant independent predictor of self-monitoring of blood pressure, but not blood pressure control. A strong relationship was found between medication adherence and medication adherence self-efficacy (r = .549, p < .05).

Prevalence of blood pressure self-monitoring, medication adherence, self-efficacy, stage of change, and blood pressure control among municipal workers with hypertension.

Despite the availability of effective medications, hypertension remains inadequately managed in the United States. It has been established that medication adherence is a major strategy for controlling blood pressure. Combined interventions to promote adherence are promising, but further research is needed to understand which behaviors to target. The frequency of self-monitoring of blood pressure among municipal workers is unknown, and the literature is limited regarding assessing individuals' readiness and confidence to engage in medication adherence. The purpose of this study was to determine the prevalence of medication adherence, readiness, self-efficacy, self-monitoring of blood pressure, and blood pressure control among hypertensive municipal workers. The study population was enrolled in a wellness program established more than 20 years ago to promote health and safety for a work force in a large southeastern U.S. city. The majority of the study participants (75.7%) demonstrated controlled blood pressure, reported adherence to antihypertensive medication (70%), and self-monitored blood pressure (70%).

Do social support, stigma, and social problem-solving skills predict depressive symptoms in people living with HIV? A mediation analysis.

Social support, stigma, and social problem solving may be mediators of the relationship between sign and symptom severity and depressive symptoms in people living with HIV (PLWH). However, no published studies have examined these individual variables as mediators in PLWH. This cross-sectional, correlational study of 150 PLWH examined whether social support, stigma, and social problem solving were mediators of the relationship between HIV-related sign and symptom severity and depressive symptoms. Participants completed self-report questionnaires during their visits at two HIV outpatient clinics in the Southeastern United States. Using multiple regression analyses as a part of mediation testing, social support, stigma, and social problem solving were found to be partial mediators of the relationship between sign and symptom severity and depressive symptoms, considered individually and as a set.

Relationships among self-efficacy, social support, social problem solving, and self-management in a rural sample living with type 2 diabetes mellitus.

Self-management behaviors are important for control of type 2 diabetes mellitus. Therefore, determining factors that promote effective self-management behaviors may be significant for improving the well-being of patients with type 2 diabetes mellitus. This study examined relationships among self-efficacy, social support, social problem solving, and diabetes self-management behaviors. Further, this study evaluated whether social support and social problem solving were mediators of the relationship between self-efficacy and diabetes self-management behaviors in those living with type 2 diabetes mellitus. Using a cross-sectional, descriptive correlational design, data from a convenience sample of 152 rural people living with type 2 diabetes mellitus were examined. Findings indicated that self-efficacy was a strong predictor of diabetes self-management. The effect of social support on diabetes self-management differed among men and women in the sample. Social support and social problem solving were significantly associated with diabetes self-management in men. Neither social support nor social problem solving were mediators of the relationship between self-efficacy and diabetes self-management in this sample. These findings suggest that nurses need to consider implementing interventions to improve patients' self-efficacy and potentially influence diabetes self-management.

Scientific misconduct from the perspective of research coordinators: a national survey.

OBJECTIVE: To report results from a national survey of coordinators and managers of clinical research studies in the US on their perceptions of and experiences with scientific misconduct. METHODS: Data were collected using the Scientific Misconduct Questionnaire-Revised. Eligible responses were received from 1645 of 5302 (31%) surveys sent to members of the Association of Clinical Research Professionals and to subscribers of Research Practitioner, published by the Center for Clinical Research Practice, between February 2004 and January 2005. FINDINGS: Overall, the perceived frequency of misconduct was low. Differences were noted between workplaces with regard to perceived pressures on investigators and research coordinators, and on the effectiveness of the regulatory environment in reducing misconduct. First-hand experience with an incident of misconduct was reported by 18% of respondents. Those with first-hand knowledge of misconduct were more likely to report working in an academic medical setting, and to report that a typical research coordinator would probably do nothing if aware that a principal investigator or research staff member was involved in an incident of misconduct. CONCLUSION: These findings expand the knowledge on scientific misconduct by adding new information from the perspective of research coordinators. The findings provide some data supporting the influence of workplace climate on misconduct and also on the perceived effectiveness of institutional policies to reduce scientific misconduct.