• Title/Summary/Keyword: repeated medication

Search Result 59, Processing Time 0.029 seconds

Confidence Bounds following Adaptive Group Sequential Tests with Repeated Measures in Clinical Trials (반복측정자료를 가지는 적응적 집단축차검정에서의 신뢰구간 추정)

  • Joa, Sook Jung;Lee, Jae Won
    • The Korean Journal of Applied Statistics
    • /
    • v.26 no.4
    • /
    • pp.581-594
    • /
    • 2013
  • A group sequential design can end a clinical trial early if a confirmed efficacy or a futility of study medication is found during clinical trials. Adaptation can adjust the design of clinical trials based on accumulated data. The key to this methodology is considered to control the overall type 1 error rate while maintaining the integrity of clinical trials. The estimation would be more complex and the sample size calculation will be more difficult if the clinical trials have repeated measurement data. Lee et al. (2002) suggested a repeated observation case by using the independent increments properties of the interim test statistics and investigated the properties of the proposed confidence interval based on the stage-wise ordering. This study extend Lee et al. (2002) to adaptive group sequential design. We suggest test statistics for the adaptation as redesigning the second stage of clinical trials and induce the stage-wise confidence interval of parameter of interests. The simulation will help to confirm the suggested method.

Decreased Nocturnal Blood Pressure Dipping in Patients with Periodic Limb Movements in Sleep (수면중 주기성 사지 운동에서 나타나는 야간 혈압 강하의 감소)

  • Lee, Mi Hyun;Choi, Jae-Won;Oh, Seong Min;Lee, Yu Jin
    • Sleep Medicine and Psychophysiology
    • /
    • v.25 no.2
    • /
    • pp.51-57
    • /
    • 2018
  • Objectives: Previous studies have shown that periodic limb movements in sleep (PLMS) could be one of risk factors for cardiovascular morbidity. The purpose of this study was to investigate the association between PLMS and blood pressure changes during sleep. Methods: We analyzed data from 358 adults (176 men and 182 women) aged 18 years and older who were free from sleep apnea syndrome (Respiratory Disturbance Index < 5) and sleep disorders such as REM sleep behavior disorder or narcolepsy. Demographic characteristics, polysomnography records, and clinical variable data including blood pressure, body mass index, alcohol, smoking, and current medications were collected. In addition, self-report questionnaires including the Beck Depression Index, Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index were completed. Blood pressure change from bedtime to awakening was compared between the two periodic limb movement index (PLMI) groups [low PLMI ($PLMI{\leq}15$) and high PLMI (PLMI > 15)]. Blood pressure change patterns were compared using repeated measures analysis of variance. Results: Systolic blood pressure in the high PLMI group was lower than that in the low PLMI group (p = 0.036). These results were also significant when adjusted for gender and age, but were not statistically significant when adjusted for BMI, alcohol, smoking, anti-hypertension medication use and sleep efficiency (p = 0.098). Systolic blood pressure dropped by 9.7 mm Hg in the low PLMI group, and systolic blood pressure in the high PLMI group dropped by 2.9 mm Hg. There was a significant difference in delta systolic blood pressure after sleep between the two groups in women when adjusted for age, BMI, alcohol, smoking, antihypertensive medication use and sleep efficiency (p = 0.023). Conclusion: PLMS was significantly associated with a decreasing pattern in nocturnal BP during sleep, and this association remained significant in women when adjusted for age, BMI, alcohol, smoking, antihypertension medication use and sleep efficiency related to blood pressure. We suggest that PLMS may be associated with cardiovascular morbidity.

Role of Repeated Education to the Patients with Temporomandibular Disorders (측두하악장애 치료에 있어서 반복적 주의사항 교육의 효과)

  • Ok, Soo-Min;Heo, Jun-Young;Ko, Myung-Yun;Ahn, Yong-Woo;Jeong, Sung-Hee
    • Journal of Oral Medicine and Pain
    • /
    • v.38 no.1
    • /
    • pp.69-76
    • /
    • 2013
  • Aim : The purpose of this study was to investigate the hypothesis that treatment with self-checking behavior management program was valuable in the management of temporomandibular disorders compared with a existing method treatment group. Methods : All participants who are diagnosed with temporomandibular disorders were treated with medication and physical therapy. They came into the clinic at intervals of two weeks, three times. The signs and symptoms were assessed investigating Pain NRS(Numerical Rating Scale), MCO(Maximum comfortable opening), Noise NRS, LOM(Limitation of Mouth opening) NRS at every visit. Experimental group received instructions repeatedly by using self evaluation questionnaire. Control group was educated once at the beginning of treatment. The difference Pain NRS, MCO, Noise NRS, LOM NRS between first and second visits, first and third visits were estimated.. Result :Experimental group showed greater improvement on MCO difference after stopping medication(p=0.001). This improvements were prominent in the male(p=0.001) and the first or second decade of the patients(p=0.004). Conclusion : The present study showed that there was better result when educating repeatedly with using self evaluation questionnaire than educating once at the beginning of the treatment.

Wild Ginseng Attenuates Anxiety- and Depression-Like Behaviors During Morphine Withdrawal

  • Lee, Bom-Bi;Kim, Hyuk;Shim, In-Sop;Lee, Hye-Jung;Hahm, Dae-Hyun
    • Journal of Microbiology and Biotechnology
    • /
    • v.21 no.10
    • /
    • pp.1088-1096
    • /
    • 2011
  • The purpose of this study was to evaluate whether wild ginseng (WG) administration could attenuate anxiety- and depression-like behaviors and expression of corticotrophin-releasing factor (CRF) and neuropeptide Y (NPY) following withdrawal from repeated morphine administration in rats. Male rats were administered daily doses of WG (50, 100, or 200 mg/kg, i.p.) for 5 days, 30 min before morphine injection (40 mg/kg, s.c). The anxiety- and depression-like behavioral responses were measured 72 h after the last morphine injection using an elevated plus maze (EPM) and forced swimming test (FST), respectively. Changes in hypothalamic CRF and NPY expressions were also examined by analyzing their immunoreactivities in the hypothalamus. Daily administration of WG significantly reduced anxiety- and depression-like behavior, and elicited the suppression of CRF expression and the stimulation of NPY expression in the hypothalamus. Our results demonstrated that WG extract might be effective at inhibiting the anxiety and depression responses due to morphine withdrawal by possibly modulating the hypothalamus CRF and NPY systems. Furthermore, these findings imply that WG extract can be used for developing new medication to cure or alleviate morphine withdrawal symptoms and to prevent relapses of morphine use.

The Effect of Human Potential Seminars on the Perceived Stigma of Adults with Epilepsy (잠재력훈련 집단상담이 성인 간질환자의 치욕감에 미치는 효과)

  • 김은자
    • Journal of Korean Academy of Nursing
    • /
    • v.28 no.4
    • /
    • pp.1003-1012
    • /
    • 1998
  • The purpose of this research was to identify the effect of human potential seminars on the perceived stigma of adults with epilepsy. The research employed a quasi experimental design and unequivalent control group pre-post design. The test was conducted on 15 adults with epilepsy attending one psychiartric out-patient clinic in Masan City, Korea. The stigma questionnaire was used as a pre-test to these patients. HPS was done ten times for five weeks from May 6, to July 26, 1996. The stigma questionnaire was again given, but this time as a post test. The control group of 14 adults with epilepsy were receiving medication at the same clinic. The human potential seminars were structured by McHolland(1972) and translated by Lee, Hae Seung(1990). The stigma research tool was modified and revised to be appropriate to Korean culture. It consisted of 15 sentences. The internal consistency was 0.92 with Cronbach's α. Research results are as follows. 1) To determine the homogenity of the experimental and control groups, the pre-stigma results were used and democratic-sociologic characteristics, job characteristics and disease related variables were compared. There was no significant difference between the two groups. 2) To identify the relationship between stigma and patient characteristics a pre-test was done. The study used both Mann-Whitney U-test and ANOVA test for statistical analysis. The variables related to stigma were the reason of unemployment and age at onset of epilepsy. 3) The test results of the effect of the human potential seminars on stigma in the patients with epilepsy, showed that stigma in the experimental group was lower than in the control group. The statistical method used to determine the difference between pre and post stigma results was the Wilcoxon signed rank test. The test results were statistically significant at the one percent level. 4) As a follow-up evaluation ten more patients(66.7% of the total) were additionally tested. In order to investigate if the stigmas were different between the pre, post and follow-up, Repeated measure ANOVA was used. The test results showed that the stigma scores were statistically different between the three groups at the one percent level(F=10.06, d.f.=2, p=0.00).

  • PDF

Effect of Acupressure on Nausea-vomiting and Weight Change among Pediatric Cancer Patients Receiving Anti-cancer Chemotherapy (지압이 암환아의 오심 구토 정도와 체중변화에 미치는 효과)

  • Kim Tae-Im;Shin Yeong-Hee;Oh Min-Seok
    • Child Health Nursing Research
    • /
    • v.10 no.1
    • /
    • pp.98-107
    • /
    • 2004
  • Purpose: This study was to confirm the effect of acupressure on the emesis control and the weight change among pediatric cancer patients receiving anti-cancer chemotherapy. Method: Forty pediatric cancer patients, receiving the induction stage of chemotherapy with MTX and vincristine, were divided into control(n=20) and the intervention group(n=20). Both groups received regular anti-emesis medication, but the intervention group was added acupressure maneuver for 5 minutes on P6 point for 3 times a day for 5days: before chemotherapy, lunch and dinner by investigator during the hospitalization and by mother at home. The instruments for this study were Rhode's(1986) Index of nausea, vomiting and retching(INVR), Cas electric scale and pamphlet developed by researcher. Result: Significant differences in the degree of nausea and vomiting were observed between the control and the intervention group as measured by INVR(t=4.73; p=.01). Repeated measures ANOVA also shows that the group effect was significant(F=22.39, P=.01) as was the time effect(F=380.35, P=.01). The group by time interaction was also significant(F=5.27, P=.01). Acupressure maneuver was apparently effective in reducing the degree of chemotherapy-induced nausea and vomiting. There were also statistically significant weight loss noted in the control group than the intervention group(t=5.42, p=.01). Conclusion: Acupressure on P6 point shows an effective adjunct maneuver in reducing the degree of nausea and vomiting and conserving the weight in pediatric cancer patients. Therefore, it is proposed that acupressure should be applied as supportive nursing intervention strategies to relieve chemotherapy induced nausea and vomiting and to prevent weight loss in pediatric cancer patients.

  • PDF

Developing a Drug Information Leaflet of Antihypertensives for Senior Citizens; Employing Performance-based User-testing (수행능력 기반 사용자 평가를 활용한 노인용 고혈압치료제 안전사용설명서 개발)

  • Kim, Jin;Lee, Iyn-Hyang
    • Korean Journal of Clinical Pharmacy
    • /
    • v.26 no.3
    • /
    • pp.254-263
    • /
    • 2016
  • Objective: Written information could be helpful for senior population to adhere to complex medication therapies, but must be well prepared and empirically assessed to achieve such end. We purposed to develop a drug information leaflet for senior citizens by applying 'performance-based user-testing.' Methods: We employed a user-testing, a mixed method to figure difficulties out with patients' leaflets from the user perspective. The cycle made of test and revision can be repeated as necessary. We recruited senior citizens with age of 65 or above who were taking antihypertensive medications at the point of participating and excluded the elderly who suffered illiteracy. We firstly rectified a drug information leaflet of antihypertensive medications for the general public distributed by the Korean authority based on focus group interviews (9 participants). The revised leaflets were tested four times with 8~12 participants in each round (40 seniors in total). We targeted to develop a leaflet which more than 80% of participants understood 10 key information. Main outcomes measures were to be able to find information and be able to understand information. This study was approved by the Yeungnam University Research Ethics Committee. Results: Focus group interviews identified difficulties with small font of words, professional language, long information, and a poor structure. The leaflet was revised and in the first round questionnaire found problems with 4/10 information points; interviews disclosed all but one (normal blood pressure range) were ill-understood. The second round questionnaire and interview found fewer problems but the comprehensiveness of participants was still poor in several points. For the third and fourth rounds we revised the leaflets in the individual-targeted manner. Finally, the fourth round showed all key information found and understood by at least 80% of participants except one question about drug name. Conclusion: The drug leaflets need to be developed in a personalized mode for the seniors. There was a limit for Korean seniors to understand nonproprietary name of their drugs because they used to producers' trade names which the Korean health system predominantly works with.

A Case of Pseudomembranous Colitis (위막성 대장염 1례)

  • Chung, Moon-Kwan;Yang, Chang-Heon;Lee, Heon-Ju;Lee, Young-Hyun;Kim, Chong-Suhl;Choi, Won-Hee
    • Journal of Yeungnam Medical Science
    • /
    • v.1 no.1
    • /
    • pp.171-178
    • /
    • 1984
  • Many reports have been made concerning underlying and associated conditions causing pseudomembranous colitis and it has been documented that occurrence of pseudomembranous colitis is related with antibiotics administration. Recent study showed that Clostridium difficile produced enterotoxin by colonization in intestinal wall and leading into pseudomembranous colitis. Diagnosis is based on positive culture of Clostridium difficile, positive test of Clostridium difficile toxin and specific histological findings after observation of whitish plaque on colonoscopic or sigmoidoscopic examination. Authors have experienced one case of pseudomembranous colitis developing after long term ampicillin administration in a case with colon cancer associated with diarrhea and diagnosis was confirmed by typical pseudomembrane on biopsy following classical whitish plaque observation on sigmoidoscopic examination. Symptoms have been ameliorated by discontinuation of antibiotics and administration of metronidazole in four days and disappearance of whitish plaque on repeated sigmoidoscopic examination and improvement of clinical symptoms after 9 days of medication.

  • PDF

The Effect of a Clinic Based Incentive Program on Medication Adherence among Patients with Hypertension or Diabetes Mellitus in Incheon (인천광역시 의원기반 건강포인트제도가 고혈압·당뇨병 환자의 지속치료에 미치는 영향)

  • Cheong, Won;Yim, Jun;Oh, Dae-Kyu;Im, Jeong-Soo;Ko, Kwang Pil;Park, Ie Byung
    • Health Policy and Management
    • /
    • v.23 no.4
    • /
    • pp.427-433
    • /
    • 2013
  • Background: This study was conducted to evaluate the factors affecting adherence in patients with hypertension and type 2 diabetes mellitus before and after a clinic based patient incentive program in Incheon. Methods: An observational follow-up study was done for 28,355 patients in one registered group and 245,598 patients in a non-registered group from March 16th 2009 to December 31th 2010 in Incheon. The registration, mandatory laboratory tests and number of clinic visits were collected by merging the Incheon Chronic Disease Management System data and the National Health Insurance Corporation (NHIC) data. As a measure of patient adherence, we used a variable of prescription days from the NHIC and defined above 80% of average prescription days as an appropriate patient adherence. Repeated measures analysis of variance and logistic regression were used to analyze the differences in patient adherence and factors affecting adherence. Results: The changes in prescription days for the registered group are larger than for the non-registered group. In the logistic regression model, including the variables with sex, age, income status and number of clinic visits, the registered group exhibited a higher Odds ratio in the patient adherence. Conclusion: This study revealed the association between registration and appropriate patient adherence in patients with hypertension or type 2 diabetes mellitus.

Control of endemic diseases in breeding pigs by means of slaughter check (Slaughter check에 의한 종돈의 방역관리)

  • Kim, Bong-Hwan;Choo, Ji-Hoon;Cho, Kwang-Hyun;Park, Choi-Kyu;Jung, Byeong-Yeal
    • Korean Journal of Veterinary Research
    • /
    • v.46 no.1
    • /
    • pp.27-34
    • /
    • 2006
  • This paper describes the slaughter check results of breeding pigs from the Korean Swine Testing Station for the control of endemic diseases. Gross lesions monitored in the present study included those conditions commonly associated with economically significant subclinical herd infections: enzootic pneumonia, pleuropneumonia, pleuritis, atrophic rhinitis, liver white spots, papular dermatitis and ileitis. A total of 128 slaughter pigs were investigated at 4 subsequent tests according to the slaughter check procedures established. The prevalence of enzootic pneumonia, pleuropneumonia and pleuritis in the initial test was 67.9%, 28.6% and 17.9%, respectively. However, these were decreased to 46.7%, 6.7% and 6.7%, respectively, in the last test after implementation of counter measures including clean-up protocols and medication programs (p > 0.05). The mean pneumonic score also significantly decreased from 6.8 in the initial test to 2.8 in the last test. The prevalence of atrophic rhinitis (${\geq}score\;2$) was 32.2% and mean atrophic rhinitis score of 1.1 were recorded. However, no significant improvement of conditions was achieved with the counter measures indicating that atrophic rhinitis was originated from the source herds and lesions developed early in the life. In the initial test, prevalence of liver white spots and papular dermatitis lesions was 21.4% and 25.0%, respectively. These conditions were cleaned by the implementation of parasite control measures with all-in all-out, strict clean-up protocols and proper medications adopted in the present study (liver white spots, p = 0.0124; papular dermatitis lesions, p = 0.0055). The prevalence of ileitis lesions in slaughter pigs from the initial test was 28.6%, it could be gradually reduced by the use of repeated treatments and control measures but the effect was not so significant (p > 0.05). In conclusion, slaughter check procedures were successfully established and applied for the control of endemic diseases in the Korean Swine Testing Station.