• Title/Summary/Keyword: outcome measures

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The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

A Review of Randomized Controlled Trials of Catgut Embedding Therapy for Urinary Incontinence (요실금의 매선 치료에 대한 무작위 대조군 연구의 문헌고찰)

  • Hyun-Joo Lee;Hee-Yoon Lee;Jang-Kyung Park;Young-Jin Yoon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.37 no.2
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    • pp.58-74
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    • 2024
  • Objectives: This study aims to evaluate the efficacy of urinary incontinence treatment using catgut embedding therapy. Methods: Using electronic databases including Pubmed, EMBASE, and CAJ, we looked for randomized controlled trials that treated urinary incontinence with catgut embedding that were published between January 2000 and December 2023. The chosen clinical studies' interventions and outcomes were examined. Results: Ultimately, eight randomized controlled trials met the inclusion and exclusion criteria. Treatment group was treated with catgut embedding alone in 3 studies, and with Biofeedback Electrical Stimulation Therapy (Biofeedback EST), Kegel exercises, Herbal Medicine and Acupuncture Injection in 5 studies. Control group was treated with Biofeedback EST, Kegel exercises, Herbal Medicine, Vitamin B, Electroacupuncture (EA), Denitine Tolterodine Tartrat with Bladder Drill, Tension-free Vaginal Tape Obturator (TVT-O) and Acupoint Injection Therapy. Outcome measures are total efficacy rate, Urine pad test, Urinary frequency, Maximum bladder capacity, VRP, POP-Q, etc. 關元 (CV4) was the most frequently used acupoint in catgut embedding therapy. In all of 8 studies, treatment group was more effective for urinary incontinence than the control group. Conclusions: According to this study, catgut embedding may be useful in enhancing the therapeutic outcome for urine incontinence, either by itself or in conjunction with standard medical treatment.

Implantation of a Newly Designed Supratarsal Gold Weight versus the Traditional Pretarsal Model for the Correction of Long-standing Paralytic Lagophthalmos: A Retrospective Cohort Study

  • Natthiya Lailaksiri;Pawarit Wanichsetakul;Preamjit Saonanon
    • Archives of Plastic Surgery
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    • v.51 no.2
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    • pp.163-168
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    • 2024
  • Background The study determined to compare the clinical outcomes of traditional gold weight implantation for the correction of paralytic lagophthalmos with those of a newly designed model. Methods In this retrospective cohort study, we enrolled 30 patients (76% females; average age 60.8 ± 12 years) with facial palsy who underwent implantation of either the traditional pretarsal gold weight (PT group; n = 15) or a new supratarsal model (ST group; n = 15) from May 2014 to April 2019. The main outcome measures were the 12-month postoperative weight prominence, weight migration, improvement of lagophthalmos, upper eyelid contour, and upper eyelid ptosis. The secondary outcome was long-term (24 months) reoperative rate. Results The new model group had significantly better eyelid contour (risk ratio [RR] 3.16, 95% confidence interval [CI] 1.62-6.15, p = 0.001), less weight prominence (RR 1.74, 95% CI 1.13-2.70, p = 0.013), less weight migration (RR 1.31, 95% CI 1.12-1.54, p = 0.001), and less eyelid ptosis (RR 2.36, 95% CI 1.21-4.59, p = 0.011) than the traditional model group. Improvement of lagophthalmos was not statistically significant between the two groups (RR 1.44, 95% CI 0.72-2.91, p = 0.303). The 24-month reoperative rate was 53.3% in the PT group versus 13.3% in the ST group (RR 2.00, 95% CI 1.15-3.49, p = 0.015). Conclusion The newly designed supratarsal gold weight showed superior postoperative outcomes than the standard traditional model.

Hybrid argon plasma coagulation in Barrett's esophagus: a systematic review and meta-analysis

  • Sagar N. Shah;Nabil El Hage Chehade;Amirali Tavangar;Alyssa Choi;Marc Monachese;Kenneth J. Chang;Jason B. Samarasena
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.38-49
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    • 2023
  • Background/Aims: Patients with Barrett's esophagus are at increased risk of developing esophageal adenocarcinoma. Endoscopic therapies aim to eradicate dysplastic and metaplastic tissues. Hybrid argon plasma coagulation (hybrid-APC) utilizes submucosal fluid injection to create a protective cushion prior to ablation that shields the submucosa from injury. We performed a pooled meta-analysis to evaluate the safety and efficacy of hybrid-APC. Methods: We conducted a systematic search of major electronic databases in April 2022. Studies that included patients with dysplastic and non-dysplastic Barrett's esophagus undergoing treatment with hybrid-APC were eligible for inclusion. Outcome measures included complete remission of intestinal metaplasia (CR-IM), stricture formation, serious adverse events, and number of sessions necessary to achieve CR-IM. Results: Overall pooled CR-IM rate for patients undergoing hybrid-APC was 90.8% (95% confidence interval [CI], 0.872-0.939; I2=0%). Pooled stricture rate was 2.0% (95% CI, 0.005-0.042; I2=0%). Overall serious adverse event rate was 2.7% (95% CI, 0.007-0.055; I2=0%). Conclusions: Results of the current meta-analysis suggest that hybrid-APC is associated with high rates of CR-IM and a favorable safety profile. Interpretation of these results is limited by the inclusion of retrospective cohort and case series data. Randomized controlled trials that standardize treatment and outcome evaluation protocols are necessary to understand how this treatment option is comparable to the current standards of care.

Latarjet operation carries three times the risk of failure in seizure versus non-seizure recurrent anterior dislocation of the shoulder joint: outcome of a systematic review with meta-analysis

  • Alok Rai;Dushyant Chouhan;Sandeep Kumar Nema;Arkesh Madegowda;Rudra Narayan;Bikram K. Kar
    • Clinics in Shoulder and Elbow
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    • v.27 no.2
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    • pp.160-168
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    • 2024
  • Background: Recurrent anterior shoulder dislocation (RASD) in cases of seizure disorders (SDs) total 50%-80% of all SD-associated shoulder instabilities. Based on the extent of bone loss, treatment options include bony and soft-tissue reconstructions, arthroplasty, and arthrodesis. The primary objective of this paper was to review the treatment options for RASD in SDs. Methods: Several bibliographic databases were searched for RASD treatment options in SD patients. The demographic outcome measures, the failure rate (defined as the relative risk of recurrence of dislocation postoperation), and the postoperative seizure recurrence rate were recorded. Results: We pooled 171 cases (187 shoulders) from 11 studies. Of these, one, five, two, two, and one reports studied Bankart's operation with remplissage (27 cases/29 shoulders), the Latarjet procedure (106/118), bone block operation (21/23), arthroplasty (11/11), and arthrodesis (6/6), respectively, in treating SD-associated RASD. The relative risk of failure between SD and non-SD patients was 3.76 (1.36-10.38) after the Latarjet operation. The failure rates were 17% and 13% for Bankart's operation with remplissage and the Latarjet procedure in SD patients, respectively, but 0% each for bone block operation, arthroplasty, and arthrodesis. The total rate of seizure recurrence after operation was 33% of the pooled cases. Conclusions: SD recurrence in the postoperative period, the size of the bone block, and the muscular attachments to a small coracoid autograft are the determinants of failure among various reconstructive operations in SD-associated RASD.

The Determination of Trust in Franchisor-Franchisee Relationships in China (중국 프랜차이즈 시스템에서의 본부와 가맹점간 신뢰의 영향요인)

  • Shin, Geon-Cheol;Ma, Yaokun
    • Journal of Global Scholars of Marketing Science
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    • v.18 no.2
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    • pp.65-88
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    • 2008
  • Since the implementation of economic reforms in 1978, the Chinese economy grows rapidly at an average annul growth rate of 9% over the post two decades. Franchising has been widely recognized as an important source of entrepreneurial activity. Trust is important in that it facilitates relational exchanges by permits partners to transcend short-run inequities or risks to concentrate on long-term profits or gains. In the relationship between the franchisors and franchisees, trust has been described as an important source of competitive advantage. However, little research has been done on the factors affecting trust in Chinese franchisor-franchisee relationships. The purpose of this study is to investigate what factors affect the trust in the franchise system in China, and to provide guidelines and insights to franchisors which enter Chinese market. In this study, according to Morgan and Hunt (1994), trust is defined as the extending when one party has confidence in an exchange partner's reliability and integrity. We offered a conceptual model of the empirical study. The model shows that the factors affecting the trust include franchisor's supports, communication, satisfaction with previous outcome and conflict. We also suggested the franchisor's supports and communication like to enhance the franchisee's satisfaction with previous outcome, and the franchisor's supports, communication and he franchisee's satisfaction with previous outcome tend to decrease conflict. Before the formal study, a pretest involving exploratory interviews with owners from three franchisees was conducted to make sure the questionnaire was relevant and clear to the respondents. The data were collected using trained interviewers to carry out personal interviews with the aid of an unidentified, muti-page, structured questionnaire. The respondents comprised of owners, managers, and owner managers of franchisee-owned food service franchises located in Beijing, China. Even though a total of 256 potential franchises were initially contacted, the finally usable sample consisted of 125 respondents. As expected, the sampling method was successful in soliciting respondents with waried personal and firm characteristics. Self-administrated questionnaires were used for all measures. And established scales were used to measure the latent constructs in this study. The measures tapped the franchisees' perceptions of the relationship with the referent franchisor. Five-point Likert-type scales ranging from "strongly disagree" (=1) to "strongly agree" (=7) were used throughout the constructs (trust, eight items; support, five items; communication, four items; satisfaction, six items; conflict, three items). The reliability measurements traditionally employed, such as the Cronbach's alpha, were used. All the reliabilities were greater than.80. The proposed measurement model was estimated using SPSS 12.0 and AMOS 5.0 analysis package. We conducted A series of exploratory factor analyses and confirmatory factor analyses to assess the convergent validity, discriminant validity, and reliability. The results indicate reasonable overall fits between the model and the observed data. The overall fit of measurement model were $X^2$= 159.699, p=0.004, d.f. = 116, GFI =.879, NFI =.898, CFI =.969, IFI =.970, TLI =.959, RMR =.058. The results demonstrated that the data reasonably fitted the model. We also examined construct reliability and reliability and average variance extracted (AVE). The construct reliability of each construct was greater than.80 and the AVE of each construct was greater than.50. According to the analysis of Structure Equation Modeling (SEM), the results of path model indicated an adequate fit of the model: $X^2$= 142.126, p = 0.044, d.f. = 115, GFI =.892, NFI =.909, CFI =.981, IFI =.981, TLI =.974, RMR =.057. As hypothesized, the results showed that it is strategically important to establish trust in a franchise system, and the franchisor's supports, communication and satisfaction with previous outcome tend to reinforce franchisee's trust. The results also showed trust seems to decrease as the experience of conflict episodes increases. And we also noticed that franchisor's supports and communication tend to enhance the franchisee's satisfaction with previous outcome, and communication tend to decrease conflict. If the trust between the franchisor and franchisee can be established in a franchise system, franchising offers many benefits and reduces many costs. To manage a mutual trust of relationship with their franchisees, franchisor's should provide support effectively to their franchisees. Effective assistant services have direct effect on franchisees' satisfaction with previous outcome and trust in franchisor. Especially, franchise sales process, orientation, and training in the start-up period are key elements for success of the franchise system. Franchisor's support is an accumulated separate satisfaction evaluation with different kind of service provided by the franchisor. And providing support definitely can improve the trustworthy image of the franchisor. In the franchise system, conflicts of interests and exertions of different power sources are very common. The experience of conflict episodes seems to negatively relate to trust. Therefore, it is important to reduce the negative side of the relationship conflicts. Communication actually plays a broader role in reducing conflict and establish mutual trust in franchisor-franchisee relationship. And effective communication between franchisors and franchisees can improve franchisees' satisfaction toward the franchise system. As the diversification of Chinese markets, both franchisors and franchisees must keep the relevant, timely, and reliable communication. And it is very important to improve the quality of communication. Satisfaction with precious outcomes seems to positively relate to trust. Franchisors and franchisees that are highly satisfied with the previous outcomes that flow from their relationship will perceive their partner as advancing their goal achievement. Therefore, it is necessary for both franchisor and their franchisees to make the welfare of partner with effort. Little literature has focused on what factors affect the trust between franchisors and their franchisees in China. This study developed the hypotheses regarding the factors affecting trust in the transaction relationship. The results of data analysis supported the hypotheses strongly. There are certain limitations in this study. First, we may point out that some other factors missed in this study could be significantly important. Second, the context of this study, food service industry, limits its potential generalizability for all franchise systems. More studies in different categories of franchise system are needed to broaden its generalizability. Third, the model was tested empirically in a sample in Beijing, more empirical tests of the proposed model in other Chinese areas are needed. Finally, the analysis in this study was solely based on the perception of franchisees and the opinions of franchisors were not included.

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Health Insurance Benefit Criteria and Quality Assurance Policies of Diagnostic Ultrasound Services in Other Countries (주요국의 초음파검사 시행현황과 질 확보방안)

  • Chung, Seol Hee;Lee, Hye Jin;Kim, Han Sang;Oh, Ju-Yeon
    • Health Policy and Management
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    • v.24 no.2
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    • pp.109-119
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    • 2014
  • In accordance with the government's plan to expand the national health insurance (NHI) coverage for severe diseases such as cancer, heart disease, cerebrovascular disease, and rare and incurable disease, the diagnostic ultrasound services have been covered by NHI from October 1, 2013. The quality is very important factor in providing diagnostic services because they influence on the diagnosis, treatment, and outcome of diseases. In particular, equipments and health care providers plays an important role in providing qualitative services. The purpose of this paper is to examine the major feature of ultrasound services covered by health security system and to review quality assurance policies in other countries such as Australia, Japan, the USA, and Canada. In addition, we assessed the implication of those policies. We especially put emphasis on the types and qualifications of healthcare professionals and measures to manage equipments. All countries have reviewed on policies to promote the quality such as educational requirements of professionals or restrictions on the duration of equipment usage. Various measures should be implemented to assure the qualitative ultrasound service.

Relationship of neck disability index, shoulder pain and disability index, and visual analogue scale in individuals with chronic neck pain

  • Hwang, Sujin;Mun, Mee-Hyang
    • Physical Therapy Rehabilitation Science
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    • v.2 no.2
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    • pp.111-114
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    • 2013
  • Objective: Several muscles surrounding neck are vital not only for neck motion, but for upper extremities motions as well. Neck pain would affect neck and shoulder disability. The Neck Disability Index (NDI), Shoulder Pain and Disability Index (SPADI), and Visual Analogue Scale (VAS) are increasingly used to evaluate treatment effectiveness after chronic neck pain. The purpose of this study was to analyze the correlation of neck pain, shoulder pain, and quality of life in patients with chronic neck pain. Design: Cross-sectional study. Methods: Forty-three patients with neck pain participated in this study. Participants were instructed to place a mark on each item of three clinical measures that best represented their experience of his/her neck and shoulder problem over the last week. The outcome measures of the study were NDI, SPADI, and VAS for neck and shoulder pain and disability. Results: The NDI was significantly correlated with the VAS-Neck, SPADI-Pain, SPADI-Disability, SPADI-Total, and VAS-Shoulder (p<0.05). The VAS-Neck was significantly correlated with the VAS-Neck, SPADI-Pain, SPADI-Disability, SPADI-Total, and VAS-Shoulder (p<0.05). The SPADI-Total was significantly correlated with the NDI, VAS-Neck, SPADI-Pain, SPADI-Disability, and VAS-Shoulder (p<0.05). The SPADI-Pain was significantly correlated with the NDI, VAS-Neck, SPADI-Disability, SPADI-Total, and VAS-Shoulder (p<0.05). The SPADI-Disability was significantly correlated with the NDI, VAS-Neck, SPADI-Total, SPADI-Pain, and VAS-Shoulder (p<0.05). The VAS-Shoulder was significantly correlated with the NDI, VAS-Neck, SPADI-Pain, SPADI-Disability, and SPADI-Total (p<0.05). Conclusions: Neck disability in patients with chronic neck pain should be considered with disability and pain of the shoulder.

A Study on Relationship among Knowledge State, IT Support, Knowledge Sharing Process and Outcomes in Startup Teams

  • Lee, Seyoon;Lee, Hyejung;Lee, Jungwoo
    • Journal of Information Technology Services
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    • v.15 no.3
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    • pp.173-193
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    • 2016
  • Start-ups do not have enough resources such as financial capital and established customer base. Knowledge base of start-up team members is the crucial and unrivaled resource. This study tries to explicate the knowledge sharing process occurring in this knowledge base of start-up teams. Adopting the knowledge process view, detail process of knowledge sharing process model is constructed consisting of knowledge sharing speed, quality and quantity in a form of nomological net and empirically tested. In addition, preceding antecedents and consequential outcomes of this knowledge sharing is also posited as part of the research model : knowledge state of the team leading to team creativity and agility via the explicated knowledge sharing process model. Also, as this knowledge based view are triggered by the advance of IT in general, IT support is conceptualized as an antecedent and measures are operationalized. 230 data points were collected from start-up teams. Via data analysis using PLS, theoretical relationships from knowledge state, IT support, knowledge sharing process and knowledge consequences are found to be empirically supported except a few not supported. Most of all, team agility and team creativity are theoretically supported and empirically validated as critical outcome variables beyond performance measures. Though agility and creativity has been discussed as critical construct in start-up teams, it has not be much validated empirically. Also, interestingly, IT support are found to be significantly impacting the knowledge sharing process as expected. Academic contributions and implications for practice are discussed at the end with limitations and further research.

Participants' Evaluation on the Payer-driven Medication Counseling Intervention for Individuals with Chronic Disease (만성질환자 대상 맞춤형 투약상담 중재 프로그램 시범사업에 대한 평가)

  • Sohn, Hyun Soon;Jang, Sunmee;Lee, Ju-Yeun;Han, Euna
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.3
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    • pp.245-253
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    • 2016
  • Objective: This study was conducted to evaluate payer-driven medication adherence intervention program from the patient's and counselor's perspectives. Methods: Target patients for intervention were selected by retrospective adherence measures based on national health insurance claims data for hypertension, diabetes and hyperlipidemia. As a serial intervention for higher risk groups of medication non-adherence, initial direct mailing, the first direct telephone call and the second direct call or a home visit were followed. Interview approach to qualitative inquiry was used to evaluate intervention results. Results: Participants including 4 patients received telephone calls, and 4 National Health Insurance Service staff and 4 pharmacists participated as counselors were interviewed regarding their impression of the intervention program. Three major themes arose: overall perception; necessities; and suggestions for success, of the intervention. Despite short period of intervention, educational intervention by telephone counseling involving pharmacists shows potential to improve self-management of chronic disease, and pharmacist-involvement. But more sophisticated selection of target patients requiring the intervention and complementation of electronic database system would be necessary. In addition, personal disposition of counselor was revealed to be an important factor for achieving successful outcome of intervention. Conclusion: The findings suggest that the individualized counseling intervention would be an efficient option for improved medication adherence. Further researches should include longer periods of interventions, a quantitative analysis using adherence measures based on claims data and consideration of clinical benefits associated with the intervention.