• Communications for Statistical Applications and Methods
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• 제25권5호
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• pp.501-512
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• 2018

We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The required extension of the recruitment period can also be derived for a given confidence level. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials.

• Asian Pacific Journal of Cancer Prevention
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• 제13권12호
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• pp.6337-6342
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• 2012

Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

• The Journal of Korean Physical Therapy
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• 제15권1호
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• pp.155-170
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• 2003

Lumbar segmental instability is considered to represent a significant sub-group within the chronic low back pain population. This condition has a unique clinical presentation that displays its symptoms and movement dysfunction within the neutral zone of the motion segment. The loosening of the motion segment secondary to injury and associated dysfunction of the local muscle system renders it biomechanically vulnerable in the neutral zone. There in evidence of muscle dysfunction related to the control of the movement system. There is a clear link between reduced proprioceptive input, altered slow motor unit recruitment and the development of chronic pain states. Dysfunction in the global and local muscle systems in presented to support the development of a system of classification of muscle function and development of dysfunction related to musculoskeletal pain. The global muscles control range of movement and alignment, and evidence of dysfunction is presented in terms of imbalance in recruitment and length between the global stability muscles and the global mobility muscles. The local stability muscles demonstrate evidence of failure of aeequate segmental control in terms of allowing excessive uncontrolled translation or specific loss of cross-sectional area at the site of pathology Motor recruitment deficits present as altered timing and patterns of recruitment. The evidence of local and global dysfunction allows the development of an integrated model of movement dysfunction. The clinical diagnosis of this chronic low back pain condition is based on the report of pain and the observation of movement dysfunction within the neutral zone and the associated finding of excessive intervertebral motion at the symptomatic level. Four different clinical patterns are described based on the directional nature of the injury and the manifestation of the patient's symptoms and motor dysfunction. A specific stabilizing exercise intervention based on a motor learning model in proposed and evidence for the efficacy of the approach provided.

• Journal of Gastric Cancer
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• 제14권1호
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• pp.39-46
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• 2014

Purpose: According to current guidelines, perioperative chemotherapy is an integral part of the treatment strategy for advanced gastric cancer. Randomized controlled studies have been conducted in order to determine whether perioperative chemotherapy leads to improved R0 resection rates, fewer recurrences, and prolonged survival. The aim of our project was to critically appraise three major studies to establish whether perioperative chemotherapy for advanced, potentially resectable gastric cancer can be recommended on the basis of their findings. Materials and Methods: We analyzed the validity of the three most important studies (MAGIC, ACCORD, and EORTC) using a standardized questionnaire. Each study was evaluated for the study design, patient selection, randomization, changes in protocol, participating clinics, preoperative staging, chemotherapy, homogeneity of subjects, surgical quality, analysis of the results, and recruitment period. Results: All three studies had serious shortcomings with respect to patient selection, homogeneity of subjects, changes in protocol, surgical quality, and analysis of the results. The protocols of the MAGIC and ACCORD-studies were changed during the study period because of insufficient recruitment, such that carcinomas of the lower esophagus and the stomach were examined collectively. In neither the MAGIC study nor the ACCORD study did patients undergo adequate lymphadenectomy, and only about half of the patients in the chemotherapy group could undergo the treatment specified in the protocol. The EORTC study had insufficient statistical power. Conclusions: We concluded that none of the three studies was sufficiently robust to justify an unrestrained recommendation for perioperative chemotherapy in cases of advanced gastric cancer.

• 대한의용생체공학회:의공학회지
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• 제24권6호
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• pp.523-531
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• 2003

본 연구에서는 표면 전극을 사용하는 8채널 전기자극 시스템을 개발하였고. 이 시스템을 이용하여 하반신 마비한자의 근력강화를 위한 전기자극 엑서사이즈와 FES 보행을 하였다. 본 연구에서 개발한 전기자극 시스템은 컴퓨터 프로그램, 전기자극기, 그리고 컴퓨터 프로그램과 전기자극기를 연결하는 통신부분으로 구성되어 있다. 컴퓨터 프로그램에서는 마우스를 이용하여 임의의 자극 패턴을 손쉽게 구성하고 편집학 수 있으며 이렇게 구성/편집된 자극 패턴은 동원곡선(recruitment curve)을 통하여 자극 파라미터로 변환된다. 자극 파라미터는 직렬통신을 이용하여 전기자극기에 전달된다. 전기자극기는 주제어부에 1개, 각 채널에 1개씩 총 9개의 마이크로프로세서로 구성되어 있다. 주제어부의 마이크로프로세서가 컴퓨터 프로그램과 통신을 하고 각 채널의 마이크로프로세서를 제어한다. 본 연구에서 개발한 기능적 전기자극 시스템으로 하반신 마비환자에게 100주 동안 전기자극 엑서사이즈를 실시한 결과 근력, 다리둘레, 그리고 피로저항성의 증가를 볼 수 있었다. 전기자극 엑서사이즈로 무릎신근(knee extensor muscle)이 체중을 지지한 수 있을 정도로 증가한 후에 FES 보행을 시작하였고, 현재 2분 동안 50m 이상 보행할 수 있다.

• 생물정신의학
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• 제19권4호
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• Annals of Clinical Neurophysiology
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• 제7권1호
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• pp.34-36
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• 2005

Two hemiplegic cerebral palsy patients were studied to investigate the cortical mechanisms underlying preserved somatosensory capacity, using functional MRI(fMRI). Tactile stimulation was performed by brushing of palm, during fMRI study. By the affected hand stimulation, contralateral primary somatosensory cortex was activated in patient 1 and cortical area anterior to the lesion site was activated in patient 2. We suggest that reorganization of the somatosensory cortex after brain injury can be induced by recruitment of undamaged areas adjacent to lesion site.

• 대한의용생체공학회:의공학회지
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• 제22권3호
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• pp.293-301
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• 2001

A patient-specific musculoskeletal model, whose parameters can be identified noninvasively, was developed for the automatic generation of patient-specific stimulation pattern in FES. The musculotendon system was modeled as a torque-generator and all the passive systems of the musculotendon working at the same joint were included in the skeletal model. Through this, it became possible that the whole model to be identified by using the experimental joint torque or the joint angle trajectories. The model parameters were grouped as recruitment of muscle fibers, passive skeletal system, static and dynamic musculotendon systems, which were identified later in sequence. The parameters in each group were successfully estimated and the maximum normalized RMS errors in all the estimation process was 8%. The model predictions with estimated parameter values were in a good agreement with the experimental results for the sinusoidal, triangular and sawlike stimulation, where the normalized RMS error was less than 17%, Above results show that the suggested musculoskeletal model and its parameter estimation method is reliable.

• 한국의료질향상학회지
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• 제27권1호
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• pp.58-69
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• 2021

Purpose:In this study, we reviewed existing victim support programs implemented in Korea to aid in the development of psychosocial support programs for patients and guardians who have experienced patient safety incidents. Methods: We reviewed similar programs: a support program for suicide survivors operated by the Korea Psychological Autopsy Center (Korea Foundation for Suicide Prevention), a family harmony program for workers in industrial accidents operated by the National Center for Forest Therapy, and the support services for crime victims provided by the Korean Crime Victims Support Association. We reviewed the contents of each website and conducted interviews with key personnel from each institution. Results: The support program for families who have experienced suicide was developed based on the suicide prevention project at the Central Psychological Autopsy Center. The family harmony program for workers who suffered industrial accidents is operated by the National Center for Forest Therapy at the behest of the Korean Workers' Compensation and Welfare Service. The Korean Crime Victims Support Association was established by the Ministry of Justice in accordance with the Crime Victim Protection Act and provides support to victims of crime. Each program was designed and implemented considering the objectives and goals, defining their recruitment plans as well as the selection criteria for their participants, and creating quality content that adequately addressed the struggles of their participants. Conclusion: The summarization of the various types of victim support programs in this study can be helpful in the future development of psychosocial support programs for victims of patient safety incidents.

• Journal of Acupuncture Research
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• 제35권3호
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• pp.120-128
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• 2018

Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.