Psychometric evaluation of the Informed Consent Process Scale in Chinese.

BACKGROUND: Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature. RESEARCH OBJECTIVES: This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale. RESEARCH DESIGN: Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted. PARTICIPANTS: We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan. ETHICAL CONSIDERATIONS: This study was approved by two Institutional Review Boards and the autonomy of the participants was respected. FINDINGS: The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 - 'Understanding of the research', Factor 2 - 'Trust and confidence' and Factor 3 - 'Doubt and uncertainty'. The three factors accounted for is 52.954 of the total variance with Cronbach's α of .917. DISCUSSION AND CONCLUSION: The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.

Vegetation response to invasive Tamarix control in southwestern U.S. rivers: a collaborative study including 416 sites.

Most studies assessing vegetation response following control of invasive Tamarix trees along southwestern U.S. rivers have been small in scale (e.g., river reach), or at a regional scale but with poor spatial-temporal replication, and most have not included testing the effects of a now widely used biological control. We monitored plant composition following Tamarix control along hydrologic, soil, and climatic gradients in 244 treated and 172 reference sites across six U.S. states. This represents the largest comprehensive assessment to date on the vegetation response to the four most common Tamarix control treatments. Biocontrol by a defoliating beetle (treatment 1) reduced the abundance of Tamarix less than active removal by mechanically using hand and chain-saws (2), heavy machinery (3) or burning (4). Tamarix abundance also decreased with lower temperatures, higher precipitation, and follow-up treatments for Tamarix resprouting. Native cover generally increased over time in active Tamarix removal sites, however, the increases observed were small and was not consistently increased by active revegetation. Overall, native cover was correlated to permanent stream flow, lower grazing pressure, lower soil salinity and temperatures, and higher precipitation. Species diversity also increased where Tamarix was removed. However, Tamarix treatments, especially those generating the highest disturbance (burning and heavy machinery), also often promoted secondary invasions of exotic forbs. The abundance of hydrophytic species was much lower in treated than in reference sites, suggesting that management of southwestern U.S. rivers has focused too much on weed control, overlooking restoration of fluvial processes that provide habitat for hydrophytic and floodplain vegetation. These results can help inform future management of Tamarix-infested rivers to restore hydrogeomorphic processes, increase native biodiversity and reduce abundance of noxious species.

Validation of the Revised Brief Diabetes Knowledge Test (DKT2).

PURPOSE: The purpose of this study is to examine the reliability and validity of the revised Diabetes Knowledge Test (DKT2). The original test was updated to reflect current diabetes care and education guidelines. The test has 2 components: a 14-item general test and a 9-item insulin use subscale. METHODS: Two samples were used to evaluate the DKT2. The first came from an online survey company (Qualtrics, LCC) (n = 101) and the second from University of Michigan's (UofM) Diabetes Registry (n = 89). Cronbach's coefficient alpha was used to calculate reliability. To examine validity, comparisons by type of diabetes, insulin use and oral medication use, and educational level were completed. Correlations between diabetes duration and both the general test and insulin subscale were calculated for the UofM sample. RESULTS: The two samples differed demographically. While the reliabilities between the samples were disparate, when combined, the coefficient alphas demonstrated reliability for both the general test (.77) and the insulin use subscale (.84). The validation comparisons proved to be similar; different results occurred between samples but when combined demonstrated validity. CONCLUSIONS: The reliability and validity tests were inconsistent by sample. The different results can, in part, be attributed to the demographic differences between the 2 samples. With the exception of age, the samples differed in every other measured variable. However, when the samples were combined, the analyses supported the reliability and validity of the Diabetes Knowledge Test 2. The DKT2 is a quick and low-cost method of assessing general knowledge of diabetes and diabetes self-care.

A systematic review of the identification of seniors at risk (ISAR) tool for the prediction of adverse outcome in elderly patients seen in the emergency department.

The purpose of this systematic review was to evaluate the predictive validity of the Identification of Seniors at Risk (ISAR) Tool in identifying elderly patients at risk of adverse outcomes after a visit to the emergency department (ED). Since older adults are frequently sent to the ED, screening for risk of adverse outcomes in elderly patients is increasingly important in the ED. Also it is a way to ensure that interventions based on a comprehensive geriatric assessment (CGA) are provided to patients identified at risk to reduce the risk of adverse outcomes. The ISAR is a six-item risk-screening tool for elderly patients seen in the ED. However the predictive validity of ISAR is controversial. Relevant studies from January 1999 through December 2014 were searched systematically in PubMed, Cochrane Library, Web of Knowledge, Scopus, CINAHL, Elsevier ScienceDirect databases. The language was restricted to English. This review was based on the recommendations of the Cochrane Handbook of Diagnostic Test Accuracy Reviews. Ten studies (8680 patients) were included in this review. With a cutoff score at least 2, the ISAR was proved to have poor validity related to revisiting the ED (AUC: 0.59-0.60) and hospital readmission (AUC: 0.59-0.60). The predictive validity of the ISAR related to mortality and composite outcomes was graded as poor to fair. It is not suitable to use the ISAR alone for identifying seniors at risk for adverse outcomes in the ED.

Shenzhu Tiaopi granule combined with lifestyle intervention therapy for impaired glucose tolerance: a randomized controlled trial.

OBJECTIVE: The purpose of the study was to evaluate the clinical effects of the Shenzhu Tiaopi granule (SZTP) combined with a lifestyle intervention in patients with impaired glucose tolerance (IGT), who also had a spleen deficiency and damp overabundance syndrome (SDDOS). METHODS: After a one-month washout period, a total of 514 patients were randomly assigned to the control (lifestyle intervention) and experimental (SZTP plus lifestyle intervention) groups, with 257 patients in each group. Patients in the control group received the lifestyle intervention (diet and exercise) for 12 months, while the patients in the experimental group were treated with SZTP plus the lifestyle intervention for 12 months. The Traditional Chinese Medicinal (TCM) symptom scores were observed in each group before and after treatment; the conversion rates from IGT to diabetes mellitus (DM) were also measured. RESULTS: Following 12 months of treatment, the conversion rate from IGT to DM in the experimental group was significantly lower than in the control group (8.52% vs. 15.28%, P<0.05). A significantly higher number of patients with IGT reverted to normal blood glucose levels in the experimental group than in the control group (42.15% vs. 32.87%, P<0.05). In addition, after following the treatment for 12 months, the TCM symptoms of patients in the experimental group were markedly alleviated, as compared to the control group (P<0.01). CONCLUSION: The combination of SZTP and lifestyle intervention showed a reduction in the conversion from IGT to DM, and an increase in the conversion from IGT to normal blood glucose levels.

Digital photography as an educational food logging tool in obese patients with type 2 diabetes: lessons learned from a randomized, crossover pilot trial.

PURPOSE: The purpose of this pilot study is to investigate the utility of, and areas of refinement for, digital photography as an educational tool for food logging in obese patients with type 2 diabetes (T2DM). METHODS: Thirty-three patients aged 18 to 70 with T2DM, body mass index at least 30 kg/m(2), and A1C 7.5% to 9% were recruited from an endocrinology clinic and randomized to a week of food logging using a digital camera (DC) or paper diary (PD), crossing over for week 2. Patients then viewed a presentation about dietary effects on blood glucose, using patient DC and blood glucose entries. Outcomes of adherence (based on number of weekly entries), changes in mean blood glucose and frequency of blood glucose checks, and patient satisfaction were compared between methods. Patient feedback on the DC intervention and presentation was also analyzed. RESULTS: Thirty patients completed the study. Adherence was identical across methods. The mean difference in number of entries was not significant between methods. This difference increased and neared statistical significance (favoring DC) among patients who were adherent for at least 1 week (21 entries, with 2 entries per day for 5 of 7 days, n = 25). Mean blood glucose did not significantly decrease in either method. Patient satisfaction was similar between interventions. Feedback indicated concerns over photograph accuracy, forgetting to use the cameras, and embarrassment using them in public. CONCLUSION: Although the DC method was comparable to PD in adherence, blood glucose changes, and patient satisfaction in this pilot trial, patient feedback suggested specific areas of refinement to maximize utility of DC-based food logging as an educational tool in T2DM.

The chronic kidney disease self-efficacy (CKD-SE) instrument: development and psychometric evaluation.

BACKGROUND: Self-management has been associated with positive health outcomes among adults with chronic kidney disease (CKD). Perceived disease-related self-efficacy (DSE) is considered a critical component in the successful self-management of chronic disease. A valid and reliable instrument for measuring CKD patients' self-efficacy is needed. This study aims to develop and test a new instrument to measure the DSE of patients with early stage CKD. METHODS: A total of 594 Taiwanese patients with early stage CKD recruited from two medical centers and one regional hospital in southern Taiwan completed the questionnaire. The CKD self-efficacy (CKD-SE) was evaluated using exploratory factor analyses (EFA) and measures of reliability. RESULTS: EFA identified four distinct factors with loadings ranging from 0.557 to 0.970: autonomy, self-integration, problem solving and seeking social support, accounting for 64.348% of the total variance. Cronbach's alpha coefficients for the subscales ranged from 0.843 to 0.901. CONCLUSION: This promising 25-item CKD-SE instrument can be used for the early identification of patients with low DSE, thus allowing the development of interventions to help these patients attain an appropriate level of DSE.

Impact of patient level factors on the improvement of the ABCs of diabetes.

OBJECTIVE: To determine which patient factors contribute to improvements in the ABCs of diabetes following a multi-faceted diabetes care intervention. METHODS: A multi-level, cluster design, randomized controlled trial examined the effectiveness of a Chronic Care Model (CCM) intervention in an underserved community (n=119). RESULTS: Improvements in glycemic control were experienced among older subjects (p=0.02), those with higher scores on the WHO-10 Quality of Well-Being Subscale 1 (p=0.05), and those in the CCM group (p=0.04). Insulin use was associated with greater improvements in SBP and DBP. Those taking insulin (p=0.07), and those more satisfied with their diabetes care and ready to make a behavior change (p=0.08) experienced larger improvements in Non-HDLc. Medication treatment intensification (TI) did not significantly impact the ABCs. CONCLUSION: Psychosocial and sociodemographic factors explained more of the variation in the ABCs than TI, and are important contributors to clinical improvement. PRACTICE IMPLICATIONS: Providers may be able to identify and intervene on patients who are at risk for developing diabetes complications and improve the consistency, quality, and effectiveness of patient care.

3-year follow-up of clinical and behavioral improvements following a multifaceted diabetes care intervention: results of a randomized controlled trial.

PURPOSE: The purpose of this study was to determine if improvements observed in clinical, behavioral, and psychosocial outcomes measured at 12 months following a multifaceted diabetes care intervention were sustained at 3-year follow-up. METHODS: This study was a multilevel, nonblinded, cluster design, randomized controlled trial that took place in an underserved suburb of Pittsburgh, Pennsylvania, between 1999 and 2005. Eleven primary care practices, and their patients, were randomly assigned to 3 groups: chronic care model (CCM) intervention (n = 30), provider education only (PROV) (n = 38), and usual care (UC) (n = 51). Subjects were followed for 3 years. RESULTS: Improvements observed at 12-month follow-up in glycemic (-0.5%) and blood pressure control (-4.8 mm Hg), and the proportion of participants who self-monitor their blood glucose (86.7%-100%), were sustained at 3-year follow-up in the CCM group. Additional improvements occurred in non-HDLc levels in all study groups and quality of well-being scores in the CCM intervention group. All associations remained after controlling for medication treatment intensification. CONCLUSIONS: We have demonstrated that improvements in outcomes can be sustained over time following a multifaceted diabetes care intervention. Future research in this area is necessary to understand if improvements in outcomes can be sustained following diabetes self-management education (DSME) and what type of patient fares the best from multifaceted diabetes care interventions.

Patient empowerment: myths and misconceptions.

OBJECTIVE: The purpose of this article is to clarify the concept of empowerment and to correct common misconceptions about its use in diabetes care and education. METHODS: The patient empowerment approach is well suited to helping patients make self-selected changes related to weight, nutrition, and physical activity. Although the concept of patient empowerment has become an integral part of diabetes education, an accurate understanding and authentic application of empowerment has not occurred as readily. The empowerment approach is clarified and common misconceptions have been corrected. RESULTS: Embracing empowerment means making a paradigm shift that is often difficult because the traditional approach to care is embedded in the training and socialization of most health care professionals (HCPs). CONCLUSION: Unlike the traditional approach, empowerment is not something one does to patients. Rather, empowerment begins when HCPs acknowledge that patient are in control of their daily diabetes care. Empowerment occurs when the HCPs goal is to increase the capacity of patients to think critically and make autonomous, informed decisions. Empowerment also occurs when patients are actually making autonomous, informed decisions about their diabetes self-management. PRACTICE IMPLICATIONS: Clarity about all aspects of the empowerment approach is essential if it is to be used effectively.

Evaluating the Efficacy of an Empowerment-Based Self-Management Consultant Intervention: Results of a Two-Year Randomized Controlled Trial.

OBJECTIVES: This study was conducted to determine if an empowerment-based Diabetes Self-Management Consultant (DSMC) was more effective than a group receiving Mailed metabolic Assessments Only (MAO) in improving diabetes-related quality of life and blood glucose control. MATERIALS AND METHODS: A two-year clinical trial, in which 310 patients with type 2 diabetes were randomized to the DSMC intervention or the MAO group. The DSMC met with the patient to review the baseline assessments, then met with this review was patient and the patient's physician. Subsequently patients received monthly telephone calls from the DSMC who used the empowerment approach to help patients identify self-management problems, consider options, set goals and make adjustments to their diabetes self-management plans. RESULTS: The Diabetes Self-Management Consultant (DSMC) intervention resulted in improvements in diabetes related quality of life (PAID) p= .008, the Empowerment Scale p= .024, A1C p= .016, Perceived understanding of diabetes p= .001 and satisfaction with diabetes care p= .019 as compared to the MAO group. DISCUSSION/CONCLUSION: The DSMC the intervention resulted in a broad array of modest diabetes related improvements. A promising area for future research would be to test the efficacy of combining an empowerment-based DSMC intervention with case management using algorithm-based medication adjustments for higher risk patients.

Social support, quality of life, and self-care behaviors amongAfrican Americans with type 2 diabetes.

PURPOSE: The purpose of this study was to examine social support and its relationship to diabetes-specific quality of life and self-care behaviors in African Americans with type 2 diabetes. METHODS: The study followed a cross-sectional, observational design and recruited 89 African American adults, age 40 and older (mean = 60, SD = 10.5), diagnosed with type 2 diabetes. Participants completed measures assessing diabetes-specific quality of life, self-care behaviors (healthy eating, physical activity, self-monitoring of blood glucose, foot care, medication and/or insulin use), demographic background, and diabetes-related social support. Diabetes-related social support variables included amount of social support received, satisfaction with support, positive support behavior, negative support behavior, and primary source of support. RESULTS: Stepwise regressions, controlling for demographic variables, were conducted to identify predictors of diabetes-specific quality of life and self-care behaviors from the diabetes-related social support variables. Satisfaction with support was a predictor for improved diabetes-specific quality of life (r = -.579, P < .001) and blood glucose monitoring (r = .258, P < .05). Positive support behavior was a predictor for following a healthy eating plan (r = .280, P < .05), spacing out carbohydrates evenly throughout the day (r = .367, P < .01), and performing physical activity at least 30 minutes per day (r = .296, P < .05). Negative support behavior was a predictor for not taking medication as recommended (r = -.348, P < .01). CONCLUSIONS: Findings indicate that social support plays a role in diabetes-specific quality of life and self-management practices. Social support encompasses multiple dimensions that differentially influence specific diabetes health-related outcomes and behaviors.

The art and science of diabetes education: a culture out of balance.

In the past 20 years, behavioral science has helped create a growing body of theoretically derived, evidenced-based approaches to diabetes patient education. Health care professionals in all disciplines are being required to demonstrate that their practice is evidence based. For diabetes educators, behavioral science is the source of much of that evidence. However, effective diabetes education involves a combination of art and science. Establishing a therapeutic alliance with patients is an art. Diabetes educators must have the interpersonal skills, values, and personal traits needed to cultivate relationships with patients that are characterized by trust, respect, and acceptance. They must feel and be able to express compassion, empathy, and warmth. However, if someone outside the field were reviewing diabetes education evaluation research, they would probably conclude that diabetes educators are interchangeable cogs in a wheel. The positive impact of the therapeutic alliance is well documented in the counseling, psychotherapy, education, and nursing literature. However, evidence to support the important role of the diabetes educator's values, interpersonal skills, and ability to establish a therapeutic alliance with patients is absent from that literature. Valid and reliable measures used to document the impact of interpersonal skills counselors and teachers could be used in diabetes education with little or no adaptation. The evidence and tools exist; we now need to determine if the will exists.

Development and testing of the Diabetes Self-management Instrument: a confirmatory analysis.

The purpose of this study was to develop and psychometrically test a new instrument for measuring self-management of adults with type 2 diabetes. Data were collected from 634 diabetic adults recruited from three teaching hospitals in Taiwan. Construct validity was determined by confirmatory factor analysis (CFA). Tests of internal consistency and test-retest were used to assess the reliability of the diabetes self-management instrument (DSMI). Initial results of CFA did not fully support the proposed five-factor model. After the model was modified, the fit indices indicated that this model fits the data best. This model was further cross validated in a second sample. Cronbach's alpha coefficient of the DSMI total scale was .94. The test-retest correlations for the DSMI total scale were acceptable (r = .73, p < .01).

Diabetes self-management experience: a focus group study of Taiwanese patients with type 2 diabetes.

AIMS AND OBJECTIVES: The purpose of this study was to understand and document the perspectives of Taiwanese patients with type 2 diabetes regarding the processes and strategies used to self-manage their chronic condition. BACKGROUND: The importance of patients learning self-management through self-regulation has been recognized in the literature, but little of this research has focused on skills to manage symptoms. Besides, studies about how patients self-manage their diabetes in term of patients' perspectives have been scant. Sociocultural context is also an influencing factor in disease management. METHODS: Focus groups were used to collect data from 41 adult participants with type 2 diabetes at three teaching hospitals located in southern Taiwan. The five focus groups ranged in size from six to ten people. The focus groups were recorded, transcribed and analysed. RESULTS: Three themes and ten subthemes were revealed. The first theme 'the impact of the illness' includes three subthemes: facing the predicament of stigmatization, concern about inheritance of diabetes and seeking alternative therapy for hope. The second theme 'self-regulation process' includes four subthemes: struggling for diet control, adjusting to psychological barriers, identifying body response and developing strategies for dealing with diabetes. The third theme 'transformation process' includes three subthemes: resuming conventional illness, support from families and fellow patients and learning to live with the disease. CONCLUSIONS: Findings obtained from the themes of the study illustrated that self-management of patients with diabetes is highly related to their own sociocultural environment and experiences. Understanding the cultural features and the meaning of illness can help in the development of interventions tailored to the needs of this cultural group. RELEVANCE TO CLINICAL PRACTICE: The findings have important implications for healthcare providers to consider individuals' sociocultural backgrounds in which they make choices about their treatment and manage their illness. This recognition will enhance patients with diabetes to transform being active in self-management through the skills of self-regulation.

A study of certified diabetes educators: influences and barriers.

PURPOSE: There were 2 related goals for this study. The first purpose was to describe the structure (type, staffing, and number of educational sessions provided), process (preferred learning approaches), and outcome measures commonly used to provide patient education. The second purpose was to identify the influences, resources, and constraints that affect and alter the attitudes and practices of diabetes educators. METHODS: A 30-item questionnaire that addressed 4 areas--demographics, practice characteristics, education program structure, and educational processes--was mailed to a sample of American Association of Diabetes Educators members. Three hundred sixty-one registered nurse and registered dietician certified diabetes educators completed the questionnaire and were included in the final analysis. RESULTS: This survey indicated that this group of certified diabetes educators has incorporated new research findings and innovative teaching methods into their practices. They experience few barriers and tend to make changes in their attitudes and practices based on scientific and experiential evidence. The 3 most highly rated influences on these changes were related to patient responses to their teaching, followed by continuing education conferences and new research findings. CONCLUSIONS: Based on these findings, providing continuing education that first and foremost incorporates experience-based examples of effective strategies supported by research published in professional journals appears to have the most influence on the practice of educators.

Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial.

OBJECTIVE: The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS: The study used a randomized controlled trial (RCT) pretest/post-test design with repeated measures. Patients were randomly assigned to either a six-week intervention group or a six-week wait-listed control group. After completing the six sessions, patients were invited to participate in one of two follow-up conditions; attend a monthly support group or receive a monthly phone call from a nurse. Assessment measures included HbA1C, lipids, blood pressure, weight, self-management behavior and psychosocial adaptation. RESULTS: Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT. These gains were maintained or improved upon during the one-year follow-up period. For patients in the two follow-up conditions, a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values. CONCLUSIONS: We believe that results of this study can be attributed to volunteer bias, study effects (ie, providing study data on several occasions to patients and their physicians during the one-year study period), and impact of the interventions. However, the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period.

Choosing and using theories in diabetes education research.

Diabetes educators use theories all the time, even if they are not aware of it. To teach, one must have some assumptions about how people learn and what constitutes effective teaching. The purpose of this article is to help diabetes educators interested in research and evaluation choose appropriate theories. The article will review the 4 purposes of theories, that is, description, explanation, prediction, and control, as well as the degree to which a theory has been articulated and elaborated. The importance of a theory's personal resonance, its explanatory power, and its utility will also be examined. The article will also review how to use 1 or more theories at each stage of a research or evaluation project.