PURPOSE: The purposes of this study were to develop a Minimal Insomnia Screening Scale for Korean adults (KMISS) and to evaluate psychometric properties and discriminant ability of the developed scale. METHODS: Data from a cross-sectional survey of 959 Korean adults were analyzed to develop the summated insomnia scale, which was evaluated in terms of reliability, validity, and discriminant ability by receiver operating characteristics (ROC) curve analysis. RESULTS: Item-total correlations ranged between .71-.79 and Cronbach's alpha was .87. Adequate validity was also evident. ROC-curve analysis showed area under ROC was .87 (95% CI: .84-.90) and identified the optimal cut-off score as < or = 20 (sensitivity, .83; specificity, .75; positive/negative predictive values, .40/.95). Using this cut-off score, the prevalence of insomnia in the study sample was 26.3% and most frequent among women and the oldest group. CONCLUSION: Data supports the psychometric properties of KMISS as a possible insomnia screening instrument. KMISS also shows promise as a convenient ultra-short screening measure of insomnia for adults and epidemiological studies in community health care settings.
Aged ; Area Under Curve ; Asian Continental Ancestry Group ; Cross-Sectional Studies ; Female ; Health Status ; Humans ; Male ; Middle Aged ; Prevalence ; *Psychometrics ; Quality of Life ; Questionnaires ; ROC Curve ; Republic of Korea ; Self Report ; Sex Factors ; Sleep Initiation and Maintenance Disorders/*epidemiology/pathology

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

OBJECTIVE: Some patients with schizophrenia may need mirtazapine augmentation to improve negative and cognitive symptoms. However there have been a few studies about the tolerability of mirtazapine augmentation to antipsychotics such as akathisia, extrapyramydal symptoms, weight gain, and body mass index (BMI). METHODS: This study was an eight-week double-blind, randomized controlled trial (RCT) of mirtazapine augmentation to risperidone. Twenty-one stabilized participants diagnosed with schizophrenia and undergoing treatment with risperidone were randomized to adjunctive treatment with mirtazapine (15 mg/day for the first two weeks, 30 mg/day for the next six weeks) or placebo. Eleven patients were assigned to the mirtazapine group, and nine patients were given placebo. RESULTS: There was no significant difference between the mirtazapine and placebo groups with respect to Barnes Akathisia rating Scale (BAS) and Sympsom-Angus Scale (SAS). However, the mirtazapine group exhibited a statistically significant increase in weight and BMI (p<0.05). CONCLUSION: These results suggest that mirtazapine augmentation can be tolerable in schizophrenic patients treated with risperidone; however, we should pay attention to the weight gain with mirtazapine. Our results should be replicated in a large-scale lengthy trial.
Antipsychotic Agents ; Body Mass Index ; Humans ; Mianserin ; Neurobehavioral Manifestations ; Psychomotor Agitation ; Risperidone ; Schizophrenia ; Weight Gain

INTRODUCTION: It is important to understand the nature of the identity through the live experiences of Home Care Nurse Practitioner(HCNP) because the role identity of a professional is constructed by continuous social interactions, This study aims to understand the construction of the role identity of HCNP. METHOD: Data was collected from 12 hospital based HCNPs. This study involved two focus group discussion sand four in-depth individual interviews. The main question was "what is the role of HCNP?" The debriefing notes and field notes were analyzed using consistent comparative data analysis method. RESULT: First, Home care (HC) is a small clinic. HCNP brings it to home to provide various services. Second, HC is the real nursing and HCNP is the 'genuine' nurse who actualizes the essence of nursing in practice. Third, HC is empowering activity to promote self-care ability of the patients and their caregivers. Forth, HC is like the dish-spinning required high-level mastery and HCNP is an expert who provides the most appropriate services to the patients. CONCLUSION: HCNPs have the role identity as a highly qualified professional who delivers services from hospital to home, actualizes the essence of nursing in practice, empowers the patients and their caregivers to have self-efficacy to recover, and offers the most appropriate nursing care.
*Nurse's Role ; *Nurse Practitioners ; Humans ; *Home Care Services ; Female ; Adult

INTRODUCTION: It is important to understand the nature of the identity through the live experiences of Home Care Nurse Practitioner(HCNP) because the role identity of a professional is constructed by continuous social interactions, This study aims to understand the construction of the role identity of HCNP. METHOD: Data was collected from 12 hospital based HCNPs. This study involved two focus group discussion sand four in-depth individual interviews. The main question was "what is the role of HCNP?" The debriefing notes and field notes were analyzed using consistent comparative data analysis method. RESULT: First, Home care (HC) is a small clinic. HCNP brings it to home to provide various services. Second, HC is the real nursing and HCNP is the 'genuine' nurse who actualizes the essence of nursing in practice. Third, HC is empowering activity to promote self-care ability of the patients and their caregivers. Forth, HC is like the dish-spinning required high-level mastery and HCNP is an expert who provides the most appropriate services to the patients. CONCLUSION: HCNPs have the role identity as a highly qualified professional who delivers services from hospital to home, actualizes the essence of nursing in practice, empowers the patients and their caregivers to have self-efficacy to recover, and offers the most appropriate nursing care.
*Nurse's Role ; *Nurse Practitioners ; Humans ; *Home Care Services ; Female ; Adult

Systemic lupus erythematosus (SLE) is a multi-system inflammatory disorder that has many symptoms. Gastrointestinal symptoms are common, while colonic involvement in the form of ischemic colitis or a colonic ulcer is rare in SLE. The differential diagnosis of ischemic proctitis with ulceration includes an infected ulcer, ulcerative colitis, Crohn's disease, solitary rectal ulcer colitis, malignant tumor, and lupus colitis. Here, we report a 22-year-old male with abdominal pain and diarrhea, who had a huge rectal ulcer that nearly obstructed the rectosigmoid junction. This turned out to be a rare gastrointestinal manifestation of lupus. He recovered after being treated with high-dose oral steroids. Our case demonstrates that a rectal ulcer is a rare, but important, complication of SLE and can be the initial clinical manifestation of the disease.
Abdominal Pain ; Colitis ; Colitis, Ischemic ; Colitis, Ulcerative ; Colon ; Crohn Disease ; Diagnosis, Differential ; Diarrhea ; Humans ; Lupus Erythematosus, Systemic ; Male ; Proctitis ; Steroids ; Ulcer ; Young Adult