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Docosahexaenoic acid (DHA) supplementation has proven beneficial in reducing preterm births. However, the challenge lies in addressing nonadherence to prescribed supplementation regimens—a hurdle that significantly impacts clinical trial outcomes. Conventional methods of adherence estimation, such as pill counts and questionnaires, usually fall short when estimating adherence within a specific dosage group. Thus, we propose a Bayesian finite mixture model to estimate adherence among women with low baseline red blood cell phospholipid DHA levels (<6%) receiving higher DHA doses. In our model, adherence is defined as the proportion of participants classified into one of the two distinct components in a normal mixture distribution. Subsequently, based on the estimands from the adherence model, we introduce a novel Bayesian adaptive trial design. Unlike conventional adaptive trials that employ regularly spaced interim schedules, the novelty of our proposed trial design lies in its adaptability to adherence percentages across the treatment arm through irregular interims. The irregular interims in the proposed trial are based on the effect size estimation informed by the finite mixture model. In summary, this study presents innovative methods for leveraging the capabilities of Bayesian finite mixture models in adherence analysis and the design of adaptive clinical trials. [ABSTRACT FROM AUTHOR]

Objective: Participant recruitment is a challenge for any clinical trial but is especially complex in cancer specifically due to the need to initiate treatment urgently. Most participants enrolled in oncology clinical trials are identified as potential participants by the oncologist or other referring provider. Optimal clinical care for patients with cancer includes consideration of participation in a clinical trial. However, the process of finding a clinical trial that is appropriate the patient can be cumbersome and time consuming. Material and Methods: The University of Kansas Cancer Center has developed a mobile application (app) which streamlines the clinical trial search process for physicians, patients, and caregivers by cohesively integrating all clinical trials currently recruiting in the center and making them easy to browse. Results: Key aspects of the app include simple filtering options, the ability to search for trials by name, easily accessible assistance, and in-app referral by phone or email. Initial feedback on the app has been very positive, with several suggestions already being implemented in future development. The app was designed to be used both by physicians to find trials, as well as patients in collaboration with their physicians. Conclusion: While long-term results will be crucial to understanding how the app can best serve our patient population, our initial results suggest that health system specific clinical trial apps can address a currently unmet need in the clinical trial recruitment process. [ABSTRACT FROM AUTHOR]

New software that performs Classical and Bayesian Instrument Development (CBID) is reported that seamlessly integrates expert (content validity) and participant data (construct validity) to produce entire reliability estimates with smaller sample requirements. The free CBID software can be accessed through a website and used by clinical investigators in new instrument development. Demonstrations are presented of the three approaches using the CBID software: (a) traditional confirmatory factor analysis (CFA), (b) Bayesian CFA using flat uninformative prior, and (c) Bayesian CFA using content expert data (informative prior). Outcomes of usability testing demonstrate the need to make the user-friendly, free CBID software available to interdisciplinary researchers. CBID has the potential to be a new and expeditious method for instrument development, adding to our current measurement toolbox. This allows for the development of new instruments for measuring determinants of health in smaller diverse populations or populations of rare diseases. [ABSTRACT FROM AUTHOR]

Our purpose was to compare frequentist, empirical Bayes, and Bayesian hierarchical model approaches to estimating reliability of health care quality measures, including construction of credible intervals to quantify uncertainty in reliability estimates, using data on inpatient fall rates on hospital nursing units. Precision of reliability estimates and Bayesian approaches to estimating reliability are not well studied. We analyzed falls data from 2372 medical units; the rate of unassisted falls per 1000 inpatient days was the measure of interest. The Bayesian methods "shrunk" the observed fall rates and frequentist reliability estimates toward their posterior means. We examined the association between reliability and precision in fall rate rankings by plotting the length of a 90% credible interval for each unit's percentile rank against the unit's estimated reliability. Precision of rank estimates tended to increase as reliability increased but was limited even at higher reliability levels: Among units with reliability >0.8, only 5.5% had credible interval length <20; among units with reliability >0.9, only 31.9% had credible interval length <20. Thus, a high reliability estimate may not be sufficient to ensure precise differentiation among providers. Bayesian approaches allow for assessment of this precision. [ABSTRACT FROM AUTHOR]

Item response theory (IRT) models provide an appropriate alternative to the classical ordinal confirmatory factor analysis (CFA) during the development of patient-reported outcome measures (PROMs). Current literature has identified the assessment of IRT model fit as both challenging and underdeveloped. This study evaluates the performance of Ordinal Bayesian Instrument Development (OBID), a Bayesian IRT model with a probit link function approach, through applications in two breast cancer-related instrument development studies. The primary focus is to investigate an appropriate method for comparing Bayesian IRT models in PROMs development. An exact Bayesian leave-one-out cross-validation (LOO-CV) approach is implemented to assess prior selection for the item discrimination parameter in the IRT model and subject content experts’ bias (in a statistical sense and not to be confused with psychometric bias as in differential item functioning) toward the estimation of item-to-domain correlations. Results support the utilization of content subject experts’ information in establishing evidence for construct validity when sample size is small. However, the incorporation of subject experts’ content information in the OBID approach can be sensitive to the level of expertise of the recruited experts. More stringent efforts need to be invested in the appropriate selection of subject experts to efficiently use the OBID approach and reduce potential bias during PROMs development. [ABSTRACT FROM AUTHOR]

At the time the study was conducted, Besher Gharaibeh, Byron Gajewski, and Diane Boyle were affiliated with School of Nursing University of Kansas, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA; Ahmed Al-smadi was affiliated with University of Ulster, Belfast, Newtownabbey Co. Antrim BT37 0QB, Jordandtown road, UK.The coexistence of diabetes and depression is associated with negative outcomes such as poor diabetes self-care management (DSCM). Complex relationships exist among diabetes knowledge, self-efficacy, self-care agency, depression and DSCM. No study has examined the relationships among all these factors at the same time. We aimed to examine relationships among depression, diabetes knowledge, self-care agency, self-efficacy and DSCM in insulin- treated people based on a modification of the DSCM model. A cross-sectional, correlational model testing design was used. Participants with type 1 (n = 35) and type 2 (n = 43) diabetes were recruited from both outpatient and community sites. Participants mean age was 46.6 years (standard deviation 13.7) and the majority were men (56.4%). Multiple regression analyses tested the hypothesised relationships. Depression was found to have a direct negative relationship with self-care agency and self-efficacy. The relationship between depression and DSCM was not direct. Self-care agency and self-efficacy completely mediated the effect of depression on DSCM. Self-efficacy completely mediated the effect of self-care agency on DSCM. We conclude that effective treatment programmes for persons managed with insulin should probably include not only screening and treatment of depression, but also skills training to enhance patient self-care agency and self-efficacy alongside DSCM. [ABSTRACT FROM AUTHOR]

Although remarkable efforts have been made to improve patient fall reporting through the utilization of standardized definitions, injury falls reporting has rarely been examined. This study used an overall intra-class correlation coefficient (ICC) estimate and factor analysis to assess the reliability and validity of the National Database of Nursing Quality Indicators® (NDNQI®) falls with injury measure. Data were collected from an online Fall Injury Level Survey that was administered to 1,159 NDNQI site coordinators (39.7% response rate; 91% registered nurses [RNs]). Estimated overall ICC was .85. Exploratory factor analysis (EFA) with a Promax rotation (root mean square error of approximation [RMSEA] = 0.053) identified three latent factors: No Injury, Minor Injury, and Moderate/Major Injuries. Final confirmatory factor analysis (CFA) assessment (comparative fit index [CFI] = 0.914, Tucker Lewis Index [TLI] = 0.910, RMSEA = 0.048) confirmed an acceptable model fit. Results provided strong evidence that the NDNQI falls with injury measure is reliable and valid in supporting hospitals’ fall prevention efforts and future injurious falls research. [ABSTRACT FROM AUTHOR]

Developing valid and reliable instruments is crucial, but costly and time-consuming in health care research and evaluation. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have set up guidelines for developing patient-reported outcome (PRO) instruments. However, the guidelines are not applicable to cases of small sample sizes. Instead of using an exact estimation procedure to examine psychometric properties, the Bayesian Instrument Development (BID) method integrates expert data and participant data into a single seamless analysis. Using a novel set of priors, simulated data were used to compare BID to classical instrument development procedures and test the stability of BID. To display BID to non-statisticians, a graphical user interface (GUI) based on R and WINBUGS is developed and demonstrated with data on a small sample of heart failure patients. Costs were saved by eliminating the need for unnecessary continuation of data collection for larger samples as required by the classical instrument development approach. [ABSTRACT FROM PUBLISHER]

The purpose of this descriptive methodological study was to develop and evaluate the psychometric properties of the Employer's Support for Breastfeeding Questionnaire (ESBQ). The convenience sample consisted of 380 business owners, managers, or supervisors from the Midwestern United States. Data were collected using Web and paper-based questionnaires from January to March 2008. Psychometric evaluation included item analysis, scale reliability, and construct validity. The ESBQ subscales had Cronbach's alphas ranging from 0.85 to 0.92. Most inter-item and item-to-total correlations were above the recommendation of 0.30. The test-retest reliability of each subscale ranged from 0.93 to 1.0. Confirmatory factor analysis supported the construct validity of the scale. The comparative fit index (CFI) and the non-normal fit index (NNFI) were 0.90 and 0.91, respectively, and the root mean square error of approximation (RMSEA) was 0.05. Findings supported the ESBQ as reliable, valid, and theoretically consistent with the theory of planned behavior. [ABSTRACT FROM AUTHOR]

Resistiveness to care is common in older adults with dementia. Resistiveness to care disrupts nursing care, increasing costs of care by 30%. Elderspeak (infantilizing communication used by nursing staff) may trigger resistiveness to care in individuals with dementia. Videotaped care episodes (n = 80) of nursing home residents with dementia (n = 20) were coded for type of staff communication (normal talk and elderspeak) and subsequent resident behavior (cooperative or resistive to care). Bayesian statistical analysis tested relationships between staff communication and subsequent resident resistiveness to care. The probability of resistiveness to care varied significantly with communication (Bayes P = .0082). An increased probability of resistiveness to care occurred with elderspeak (.55, 95% CrI, .44-.66), compared with normal talk (.26, 95% CrI, .12-.44). Communication training has been shown to reduce elderspeak and may reduce resistiveness to care in future research. [ABSTRACT FROM AUTHOR]

The purpose of this study is to explore the relationship between nursing home staffs' perceptions of organizational processes (communication, teamwork, and leadership) with characteristics (turnover, tenure, and educational preparation) of the nursing home administrator (NHA) and director of nursing (DON). NHAs and DONs rate communication, teamwork, and leadership significantly higher than direct care staff do (registered nurses, licensed practical nurses, certified nurse aides [CNAs]). CNAs have the lowest ratings of communication and teamwork. Turnover of the NHA and DON is significantly and negatively associated with communication and teamwork. Two thirds of DONs surveyed hold less than a baccalaureate degree; this does not influence staffs' ratings of communication, teamwork, and leadership. Findings from this study highlight the need to explore differences in perceptions between administrative and direct care staff and how these may or may not influence staff development and quality improvement activities in nursing homes. [ABSTRACT FROM AUTHOR]

Using cross-sectional data from the 2004 National Database of Nursing Quality Indicators (NDNQI) RN Satisfaction Survey, differences in RN workgroup job satisfaction were examined among 10 unit types—medical-surgical, step-down, critical care, pediatric, maternal-newborn, psychiatric, emergency department, rehabilitation, surgical services, and outpatient clinics and labs. The national sample included RN workgroups in 2,900 patient care units (55,516 RNs; 206 hospitals in 44 states). Workgroup satisfaction across all unit types was moderate. RN workgroups in pediatric units were the most satisfied, whereas those in surgical services and emergency department unit types were least satisfied. A consistent finding across all unit types was high satisfaction with the specific domains of nurse-to-nurse interaction, professional status, and professional development versus much lower satisfaction with task, decision making, and pay. Findings can be used to inform and develop investigations that examine specific aspects of the work environment for RN workgroups in various unit types. [ABSTRACT FROM AUTHOR]

There is strong evidence for the beneficial health effects associated with smoking cessation during pregnancy. Although many pregnant women spontaneously quit smoking during pregnancy, postpartum relapse is high. Evidence suggests that pregnant women do not use smoking cessation strategies as identified by the 40-item Processes of Change Scale as frequently as others who quit smoking. The purpose of this study is to identify factors associated with pregnant ex- smokers `use of experiential and behavioral smoking cessation strategies. A cross-sectional survey design is used for the study. From a sample of 201 primarily low-income pregnant women recruited to participate in a larger study, 58 were biologically confirmed ex-smokers. Multiple regression analysis reveals that motivation to quit smoking is the only significant factor explaining the use of experiential and behavioral smoking cessation strategies, accounting for 44% of the variance in experiential processes and 3 1 % of the variance in behavioral processes. [ABSTRACT FROM AUTHOR]

This descriptive, feasibility study was designed to determine how weight management patients defined spirituality and its connection with weight management. Relationships among spirituality assessment, spiritual well-being, self-esteem, and quality of life were explored. This study arose from clinical observations of possible relationships among patients' weight management failures, negative beliefs about self, and spiritual distress. Participants were 34 of 104 adult potential participants from a holistic weight management clinical practice. Survey data were analyzed using qualitative content analysis and quantitative linear regression analyses. Participants readily defined spirituality; significant linear relationships were found: Total spiritual well-being explained approximately 47% of the variance for self-esteem and existential spiritual well-being accounted for approximately 68% of the variance for self-esteem. Similarly, existential spiritual well-being explained approximately 35% of the variance of quality of life. For this convenience sample, spiritual well-being was significantly related to self-esteem and quality of life. [ABSTRACT FROM AUTHOR]

To fully support their role in translational and personalized medicine, biorepositories and biobanks must continue to advance the annotation of their biospecimens with robust clinical and laboratory data. Translational research and personalized medicine require well-documented and up-to-date information, but the infrastructure used to support biorepositories and biobanks can easily be out of sync with the host institution. To assist researchers and provide them with accurate pathological, epidemiological, and bio-molecular data, the Biospecimen Repository Core Facility (BRCF) at the University of Kansas Medical Center (KUMC) merges data from medical records, the tumor registry, and pathology reports using the Curated Cancer Clinical Outcomes Database (C3OD). In this report, we describe the utilization of C3OD to optimally retrieve and dispense biospecimen samples using these 3 data sources and demonstrate how C3OD greatly increases the efficiency of obtaining biospecimen samples for the researchers. [ABSTRACT FROM AUTHOR]