Comparison of two treatments on a covariate variable.

In clinical trials, the efficacy of treatment might be dependent on the value of a covariate variable. Therefore, it might be possible to detect the region over the covariate variable where the two treatments under investigation do not have significantly different efficacy or the region of superiority of one treatment. The non-significant region can be verified to be a confidence interval for the abscissa of the intersection point of two regression lines, and each of the complementary regions of the confidence interval corresponds to a region of superiority. In this study, we develop a method of constructing the confidence interval based on the concept of a generalized pivotal quantity, so as to perform the task of detecting the possible three regions for a clinical trial. Two real-world examples are given to illustrate the application of our proposed method, and a simulation study is conducted to evaluate its performance.

Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial.

BACKGROUND: Autonomic dysfunction, cognitive impairment, and psychological distress are associated with poorer prognosis in patients with acute ischemic stroke (AIS). Heart rate variability (HRV) biofeedback (BF) improves autonomic dysfunction, cognitive impairment, and psychological distress in other patient populations, but its effect in patients with AIS is still unclear. OBJECTIVE: This study investigated the effects of an HRVBF intervention on autonomic function, cognitive impairment, and psychological distress in patients with AIS. METHOD: In this randomized, controlled, single-blind trial, patients with AIS were randomly assigned to the experimental or control group. The experimental group received four HRVBF training sessions. The control group received usual care. Repeated measures of HRV, mini-mental status examination (MMSE), and Hospital Anxiety and Depression Scales (HADS) were collected prior to and at 1 and 3 months postintervention. RESULTS: A total of 35 patients completed the study (19 experimental, 16 control). HRV and HADS significantly improved in the experimental group (p < .001) but not in the control group. Likewise, only the experimental group showed significant improvements in HRV, MMSE, and HADS over time (p < .05). CONCLUSION: HRVBF is a promising intervention for improving autonomic function, cognitive impairment, and psychological distress in patients with AIS. More studies of HRVBF interventions are needed to further optimize the effects of HRVBF on autonomic, cognitive, and psychological function in patients with AIS.

Associations among integrated psychoneuroimmunological factors and metabolic syndrome.

BACKGROUND: Metabolic syndrome (MetS) has been reported to cause considerable psychoneuroimmunology (PNI) disturbances such as, psychological distress, autonomic nervous imbalance, and impaired immune function. Associations among these psychoneuroimmunology (PNI) factors and their integrated effects with MetS and risk components of MetS necessitate further exploration. OBJECTIVE: This study investigated associations among psychoneuroimmunological factors, their integrated effects with MetS and risk components of MetS. METHODS: This was a cross-sectional study. Participants were recruited from two health management centers at a medical center in Northern Taiwan. Demographics and data on psychological distress (e.g., perceived stress and depression) were collected using self-reported questionnaires. Heart rate variability (HRV) and C-reactive protein values (CRP) were measured to evaluate participants' autonomic nervous function and immune reaction. The risk components of MetS (e.g., elevated blood pressure, impaired fasting glucose, dyslipidemia, and abdominal obesity) were identified according to the Taiwan-specific definition of MetS and were determined based on participants' health examination profiles. RESULTS: A total of 345 participants with complete data were included for data analysis. Compared with healthy controls, participants with MetS exhibited higher depression scores (11.2±8.5 vs. 8.7±7.0), higher CRP values (2.1±2.5 vs. 0.7±1.0), and lower HRV (total power: 758.7±774.9 vs. 1064.4±1075.0). However, perceived stress in participants with MetS did not significantly differ from that of their healthy counterparts (p>0.05). Univariate analyses indicated that associations among psychoneuroimmunological factors and MetS risk components were statistically heterogeneous: a) perceived stress and depression were significantly associated only with high blood glucose (p<0.05); b) CRP was significantly associated with all MetS risk components (p<0.05); and c) HRV was significantly associated with high triglycerides and high fasting blood glucose (p<0.05). Multivariate analysis indicated that the integrated effects of depression, CRP, and HRV were significantly associated with MetS (p<0.01) after controlling for age and education level. CONCLUSIONS: Higher depression scores, higher CRP values, and lower HRV are independently and additively associated with MetS and risk components of MetS. Accordingly, a multidisciplinary approach to alleviating psychological distress, immune dysfunction, and autonomic nervous imbalance is recommended for promoting well-being in people with subclinical metabolic abnormalities or MetS to minimize downstream health consequences.

Nursing students' attitudes towards provision of sexual health care in clinical practice.

AIMS AND OBJECTIVES: To investigate nursing students' attitudes towards providing sexual health care in clinical practice and to identify associated factors. BACKGROUND: Sexual health care is an important component of holistic health care. Nurses' personal sexual knowledge and attitudes are shown to influence provision of sexual health care. DESIGN: This is a descriptive, cross-sectional study. METHODS: We selected 146 senior nursing students by convenience sampling from nursing schools in two medical universities in central Taiwan. Data were collected using the Nursing Attitudes on Sexual Health Care scale developed based on the 'Permission/Limited Information/Specific Suggestions/Intensive Therapy' model. Higher scores indicated more positive attitudes. RESULTS: Participants' mean age was 22.15 years. Mean total Nursing Attitudes on Sexual Health Care scores ranged from 45-75 (61.40 ± 10.17). Nursing students' most positive attitudes towards Permission/Limited Information/Specific Suggestions/Intensive Therapy sexual healthcare interventions were at the Permission level, and least positive attitudes were at levels of Specific Suggestion and Intensive Therapy. The top three positive items were as follows: accept patients' expression of sexual concerns, initiate discussions and encourage patients to talk. Male nursing students had negative attitudes towards sexual healthcare interventions, which became more positive as age increased, especially at the Limited Information level. CONCLUSIONS: Nursing students had different attitudes towards different levels of sexual health care in the Permission/Limited Information/Specific Suggestions/Intensive Therapy model. Attitudes were associated with age and gender. The Nursing Attitudes on Sexual Health Care scale is useful and reliable for identifying nurses' attitudes towards providing sexual health care. RELEVANCE TO CLINICAL PRACTICE: The Permission/Limited Information/Specific Suggestions/Intensive Therapy-based Nursing Attitudes on Sexual Health Care scale helps to identify nurses' attitudes. A better understanding of nurses' attitudes towards provisional sexual health care will provide information needed to develop appropriate education programmes to improve delivery of sexual health care.