Improving quality of life for a patient with fibromyalgia and their caregiver: A protocol for the application of the integrative medical service model.

OBJECTIVES: Patients with incurable diseases experience difficulty carrying out activities of daily living and rely on caregivers. Caregivers of patients with fibromyalgia (FM) are unable to understand the extent of the patients' suffering because the pain sites are invisible. To address this problem, this study will apply an integrative healthcare service model to a single FM case to manage pain and enhance the quality of life and, subsequently, gather feedback from different sources regarding the treatment. This paper presents the study protocol. METHODS: We will conduct an observational study to gather quantitative and qualitative feedback from various perspectives regarding the application of an integrative healthcare service program for FM patients developed in Korea for an FM patient-caregiver pair. The program will comprise eight 100-minute weekly sessions, during which integrative services that combine Western and Oriental medicines (Korean traditional medicine) will be provided to enhance pain management and quality of life. The feedback collected after each session will be reflected in the next session' content. RESULTS: The results will comprise the feedback from the patient and caregiver in accordance with revisions made to the program. CONCLUSIONS: The results will provide basic data for optimizing an integrative healthcare service system in Korea for patients suffering from chronic pain owing to diseases such as FM.

Improving the quality of life in a breast cancer patient and caregiver: Protocol for the application of the integrative medical service model.

BACKGROUND: Patients with chronic diseases require ongoing treatment, and caregivers face financial burdens as well as psychological and physical difficulties. However, the current healthcare system does not provide adequate systems or services to address the difficulties that patients and caregivers face. PURPOSE: The purpose of this study was to conduct an observational case study in order to evaluate and improve the application of an integrative healthcare service model developed for distress management and improved quality of life in breast cancer (BC) patients and caregivers. METHOD: The integrative healthcare service model was intensively applied to a patient-caregiver pair in this observational study. This was followed by gathering feedback from participants and experts, as well as reflecting on the content of the feedback in order to improve the model further. RESULTS: This study will then modify and improve the program with feedback and provide integrative medical services to a BC patient and caregiver. CONCLUSION: This study used the BC patients' pain management and quality of life enhancement model, aiming to provide basic data for the establishment of a healthcare service system for patients suffering from chronic pain due to diseases such as BC by systematically integrating previously applied interventions into the current healthcare system and soliciting feedback from patients and caregivers.

Introduction to methodology for the development of an integrative medical service model.

Background: The purpose of this article was to present a valid and reliable theoretical framework and method for the development of an integrated medical service model for the four major diseases. Methods: Methodologies for each process were presented based on three theoretical frameworks. The three theories were the double diamond process model, the Donabedian model, and the International Classification of Functioning, Disability, and Health model. Based on this, in the process of problem finding, a literature review, service user questionnaire, and interview methods were applied. For problem definition and solution, expert focus group interview and expert Delphi methods were applied. The subjects of the study were mainly selected from experts for each disease and users of medical services. For literature review, systematic literature review and subject range literature review were conducted, and for analysis, a meta-analysis was carried out. In the case of focus group interview and Delphi, the validity and reliability of domain derivation and sub-items were analyzed by applying the qualitative analysis method. Results: To develop an integrative medical service model, a theoretical framework and a systematic methodology were needed, and case studies were performed to prove its validity and reliability. This showed that the development of a medical service model needs to follow a scientific procedure. Conclusions: By introducing methodological approaches and procedures for the development of an integrated medical service model for the four major diseases, the researchers provided basic information on model development.

Systematic Review of Diagnostic Tools and Interventions for Sarcopenia.

Diagnosis of rare incurable diseases is important. Specific evaluation methods and standards for sarcopenia differ according to each sarcopenia-related medical association. This study aimed to identify the tools that are currently used to diagnose sarcopenia and to systematically review various interventions for sarcopenia. We intended to provide basic information to help establish standard diagnostic and therapeutic methods for sarcopenia. We collected and analyzed published journal articles, including gray literature and dissertations, from 11 domestic and international databases. The search terms were "sarcopenia/sarcopenic", "combined (complex/circuit) exercise", "resistance (muscle) exercise", and "aerobic exercise". The tools used for sarcopenia diagnosis were inconsistent across the studies. Circuit exercise combined with aerobic exercise and strength training was the most common intervention method, followed by strength training and aerobic exercise. We identified several diagnostic and evaluation criteria across the articles. Essentially, this systematic review confirms the importance of diagnostic criteria for sarcopenia and compares interventions. Hopefully, the criteria for the diagnosis and evaluation of sarcopenia will become clear in the future. In addition, the results of this study may provide basic information for rehabilitation treatment for rare and incurable diseases.

A case study on the application evaluation of integrative medical service model for the improvement of quality of life for dementia patients and caregivers.

BACKGROUND: Since 4 major diseases and geriatric diseases require consistent management, individuals with any of these diseases cannot live alone and need caregivers' assistance. Given these characteristics, an integrative medical service model for 4 major diseases and geriatric diseases was developed in Korea, currently. Dementia, one of the typical geriatric diseases, requires caregivers' assistance from the beginning because of its enormous burden. Thus, it is necessary to provide an integrative medical service that can improve the quality of life (QoL) for both patients and caregivers. Therefore, this study aims to collect various feedback by applying an integrative medical service, which was developed to improve the QoL in patients with dementia and their caregivers, to a single case, and to modify and improve the integrative medical service model based on the results. METHOD/DESIGN: The integrative medical service program, which was developed to improve the QoL in patients with dementia and their caregivers in Korea, will be used for a patient-caregiver pair. This is an observational study with quantitative and qualitative feedback from various viewpoints. The program will be conducted in 8 sessions (twice a week, within 120 minutes). The patient will receive both Western and Korean medicine, and an integrative service will be provided to improve cognitive rehabilitation and QoL. Feedback collected at each session will be reflected on the program of the subsequent session. RESULTS: This study will then modify and improve the program with feedback and provide integrative medical services to a patient with dementia and caregiver. DISCUSSION: Patients with dementia need a program that would help them maintain cognitive function, and caregivers need a program that would improve their QoL by reducing the caregiving burden. This study is unique because the developed program is performed after modification based on feedback from the previous session. Accordingly, the patient and caregiver can check which program is the most satisfactory and helpful in improving their QoL. We expect that this study can modify the integrative medical service model to the optimized patient-based model. This study can also be used as basic data for a clinical pathway development study that applies the modified model to medical institutes.

Understanding the experiences and perception of people living with HIV on integrative traditional East Asian medicine management in Korea: an interview protocol for qualitative research.

INTRODUCTION: Patients with HIV/AIDS have been able to experience the average life expectancy of the general population due to medical advancements. However, they face physical, emotional and social difficulties that worsen their quality of life. The pharmacological approach is often the first choice to address these issues, but it involves some limitations. Integrative traditional East Asian medicine (ITEAM) can compensate for the limitations of drugs and can be applied to treat physiological and psychiatric problems. In Korea, ITEAM interventions are easily accessible under the government insurance. However, the experiences, perceptions and barriers to the use of ITEAM in patients with HIV/AIDS are less studied. Therefore, we will interview them to explore their experiences and examine the strengths, limitations, barriers and improvements in the use of ITEAM. METHODS AND ANALYSIS: This is a qualitative study using a phenomenological framework. We will conduct one-to-one interviews with 3-10 patients with HIV/AIDS who have been treated with ITEAM from March 2021 to January 2022. We will present semistructured open-ended questions and analyse them using experiential phenomenological research methods. The results will be reported in accordance with the Consolidated Criteria for Reporting Qualitative Studies. ETHICS AND DISSEMINATION: This research was approved by the Institutional Review Board of the National Medical Center (IRB number, NMC-2101-008). The results of this study will be disseminated through journal articles, newspapers and conference proceedings. TRIAL REGISTRATION NUMBER: Clinical Research Information Service: KCT0005855; Pre-results.

Effect of Acupuncture on Movement Function in Patients with Parkinson's Disease: Network Meta-Analysis of Randomized Controlled Trials.

We aimed to compare the effectiveness of some different acupuncture modalities on motor function using the unified Parkinson disease rating scale (UPDRS)-III scores of idiopathic Parkinson's disease (PD) via pairwise and network meta-analyses (NMA) of randomized controlled trials (RCTs). The Cochrane risk of bias assessment tool was used to assess the methodological quality of the included RCTs. A frequentist approach-based random effect model NMA was performed. Seventeen RCTs with 1071 participants were included. The five following modalities were identified: combination of conventional medication (levodopa) with (1) electroacupuncture (ELEC), (2) manual acupuncture (MANU), (3) bee venom acupuncture (BEEV), (4) sham acupuncture (SHAM), and (5) conventional medication alone (CONV). In NMA on UPDRS-III, BEEV was the best modality compared to CONV (mean difference [MD]) -7.37, 95% confidence interval [-11.97, -2.77]). The comparative ranking assessed through NMA was suggested to be BEEV, MANU, ELEC, SHAM, and CONV. Regarding daily activity assessment (UPDRS-II), the magnitude of effectiveness was in the order of BEEV, ELEC, MANU, SHAM, and CONV. Combination treatment with BEEV (MANU or ELEC) and CONV can be recommended to improve motor function in PD patients. Due to the limited number of included RCTs, further NMA with more rigorous RCTs are warranted.

Effectiveness, Cost-Utility, and Safety of Neurofeedback Self-Regulating Training in Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial.

Post-traumatic stress disorder (PTSD) is characterized by neurophysiological and psycho-emotional problems after exposure to trauma. Several pharmacological and psychotherapy limitations, such as adverse events and low adherence, increase the need for alternative therapeutic options. Neurofeedback is widely used for PTSD management. However, evidence of its clinical efficacy is lacking. We conducted a randomized, waitlist-controlled, assessor-blinded clinical trial to assess the effectiveness, cost-utility, and safety of 16 sessions of neurofeedback on people with PTSD for eight weeks. Eleven participants were allocated to each group. One and two subjects dropped out from the neurofeedback and control groups, respectively. The primary outcome was PTSD symptom change evaluated using the PTSD Checklist-5 (PCL-5-K). The PCL-5-K levels improved more in the neurofeedback group (44.3 ± 10.8 to 19.4 ± 7.75) than in the control group (35.1 ± 18.5 to 31.0 ± 14.92). The change value was significantly improved in the neurofeedback group (24.90 ± 13.13 vs. 4.11 ± 9.03). Secondary outcomes such as anxiety, depression, insomnia, and quality of life were also improved. In an economic analysis using EuroQol-5D, the incremental cost-per-quality-adjusted life-year was approximately $15,600, indicating acceptable cost-utility. There were no adverse events in either group. In conclusion, neurofeedback might be a useful, cost-effective, and safe intervention for PTSD management.

Psychosocial Factors Related to Stroke Patients' Rehabilitation Motivation: A Scoping Review and Meta-Analysis Focused on South Korea.

The incidence of strokes in individuals in their 30-40 s-who have responsibilities towards their families-has increased. Additionally, many stroke patients suffer from post-stroke disabilities and require rehabilitation. However, especially in younger stroke patients, factors such as financial burden and the inability to be productive lead to depression and thereby, the lack of rehabilitation motivation-which affects their therapeutic outcomes. Therefore, medical interventions alone are not sufficient. This study aimed to identify the psychosocial factors that affect stroke patients' rehabilitation motivation. Hence, a scoping review was conducted to analyze the research trends across South Korean academic papers and theses, followed by a comprehensive meta-analysis to identify the correlations among the variables. Eighteen factors related to rehabilitation motivation were identified. The internal factors were depression, cognition, self-efficacy, self-esteem, disability acceptance, volition, communication, resilience, empowerment, and uncertainty. The external factors included sleep pattern, quality of life, activities of daily living, physical function, social support, financial burden, disease-related characteristics, and rehabilitation environment. Based on these findings, an intervention model should be developed to provide social support to stroke patients. Moreover, psychological interventions should be developed to enhance the self-efficacy of stroke patients who are undergoing rehabilitation.

A systematic literature review and meta-analysis of the clinical effects of aroma inhalation therapy on sleep problems.

BACKGROUND: This systematic review investigated the clinical effects of inhalation aromatherapy for the treatment of sleep problems such as insomnia. METHODS: Studies on sleep problems and inhalation aromatherapy, published in Korean and international journals, were included in the meta-analysis. Five domestic and international databases, respectively each, were used for the literature search. Keywords included sleep disorder, sleep problems, insomnia, and aroma inhalation, and the related literature was further searched. After the screening, selected articles were assessed for their quality and conducted the risk of bias using RevMan 5.0, a systematic literature review was then conducted. A meta-analysis comparing the averages was conducted on studies that reported numerical values. Additionally, meta-analysis of variance and meta-regression analyses were performed. RESULTS: Meta-analysis of the 34 studies using the random-effects model revealed that the use of aromatherapy was highly effective in improving sleep problems such as insomnia, including quantitative and qualitative sleep effects (95% confidence interval [CI], effect sizes = 0.6491). Subgroup analysis revealed that the secondary outcomes including stress, depression, anxiety, and fatigue were significantly effective. The single aroma inhalation method was more effective than the mixed aroma inhalation method. Among the single inhalation methods, the lavender inhalation effect was the greatest. CONCLUSION: Inhalation aromatherapy is effective in improving sleep problems such as insomnia. Therefore, it is essential to develop specific guidelines for the efficient inhalation of aromatherapy. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data are not included. The findings of this systematic review were disseminated through peer-reviewed publications or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42020142120.

Perception, attitude, and demand for Korean medicine and Western medicine collaborative treatment of medical occupational groups in Korea: A scoping review.

BACKGROUND: In Korea, there exists a dual medical license system whereby both traditional Korean medicine and Western medicine doctors practice independently. In 2009, via medical law revision, cross employment was allowed to activate Korean medicine and Western medicine collaborative treatment (KWCT). Despite its several advantages, there are several barriers to a well-organized KWCT. To activate KWCT, we investigated perception, attitude, demand of medical occupational groups and research gap via scoping review. METHODS: Scoping review is an emerging methodology for knowledge synthesis adopting the Arksey and O'Malley framework. The research question was "What is known about perception, attitude, demand, and research gap on KWCT?" We searched articles published from 2009 to 2019 in 7 Korean and 4 English databases. We conducted descriptive and qualitative thematic analysis and presented the research gap. RESULTS: From 1,305 articles, 6 quantitative and 3 qualitative studies were included. In quantitative studies, perception and attitude of medical occupational groups did not change markedly. For better perception and attitude, experiencing, mutual understanding, and respect should precede. Academic exchange, education, supporting KWCT research and legal/institutional/administrative support is also important. In qualitative studies, education course, guidelines, trust, safety, academic integration, and scientification were also required. We found several research gaps about KWCT especially detailed on-site demand and activation strategy about KWCT. CONCLUSION: We investigated perception, attitude, and demand on KWCT. Based on research gap in our scoping review, quantitative studies using validated questionnaire and in-depth interview are needed to identify on-site demand to improve KWCT implementation. PROTOCOL REGISTRATION: https://www.researchregistry.com/(reviewregistry830).

A protocol for systematic review and meta-analysis on psychosocial factors related to rehabilitation motivation of stroke patients.

BACKGROUND: Rehabilitation motivation is more important than any other factor in terms of treatment effects among stroke patients. The goal of this study is to explore the variables related to rehabilitation motivation that affect treatment effects and analyze their effect sizes, in order to manage the psychosocial interventions required by stroke patients. METHODS: Thirteen electronic databases will be searched from November to December 2020. The search terms will be composed of the disease term part (eg, "stroke") and the intervention term part (eg, "rehabilitation motivation or rehabilitation factors related to motivation or self-efficacy or family support or rehabilitation adherence or achievement or psychosocial factors, including self-motivation, social support, psychological distress, rehabilitation adherence"). Selected studies the for systematic review and meta-analysis will include randomized, quasi-randomized, and nonrandomized controlled trials, and research programs on rehabilitation motivation; qualitative research and case studies will be excluded. The participants will be stroke patients. Two authors will independently assess each study for eligibility and risk of bias, and to extract data. RESULTS: This study will comprehensively explore the psychosocial and physical behavioral variables related to the rehabilitation motivation of stroke patients and provide their priorities and effect sizes. In addition, we will report the magnitude of the correlation effect on the rehabilitation motivation of stroke patients according to each demographic variable. CONCLUSIONS: The conclusions of our study will provide effective evidence of psychosocial variables that influence the treatment outcomes of stroke patients. PROSPERO REGISTRATION NUMBER: CRD42020207467.

Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol.

BACKGROUND: Post-traumatic stress disorder (PTSD) has become an important public health problem. However, the conventional therapeutic strategy, including pharmacotherapy and cognitive behavioral therapy, has limitations. Neurofeedback is a technique that utilizes electroencephalography (EEG) signaling to monitor human physiological functions and is widely used to treat patients with PTSD. The purpose of our study is to assess the efficacy and safety level of neurofeedback treatment in patients with PTSD using quantitative EEG. METHODS: This is a randomized, waitlist-controlled, assessor-blinded, clinical trial. Forty-six patients with PTSD will be randomly assigned at a 1:1 ratio into two groups. The participants in the treatment group will receive neurofeedback treatment for 50 min, twice a week, for 8 weeks (16 sessions). Quantitative EEG will be utilized to monitor the physiological functions and brain waves of the participants. A four-week follow-up period is planned. The participants in the control group will wait for 12 weeks. The primary outcome is the Korean version of PTSD Checklist-5 (PCL-5-K) score. The PCL-5-K scores on week 8 will be compared between the two groups. Anxiety, depression, insomnia, emotions, EEG, quality-of-life, and safety level will be assessed as secondary outcomes. DISCUSSION: This trial will describe a clinical research methodology for neurofeedback in patients with PTSD. The numerous subjective and objective secondary outcomes add to the value of this trial's results. It will also suggest a therapeutic strategy for utilizing quantitative EEG in patients with PTSD. Our trial will provide basic evidence for the management of PTSD via an integrative treatment. TRIAL REGISTRATION: Clinical Research Information Service (CRIS): KCT0003271.

Non-pharmacological Treatment for Elderly Individuals With Insomnia: A Systematic Review and Network Meta-Analysis.

Background: Insomnia causes a huge socioeconomic burden among the elderly, and is not simply a health problem. This study aimed to determine the comparative advantage of the effectiveness and acceptability of non-pharmacological interventions available for elderly individuals with insomnia. Methods: Comprehensive searches in 13 medical databases were performed to find relevant randomized controlled trials (RCTs) up to August 2019. Two independent reviewers performed study selection, data extraction, and quality assessment of included RCTs using the Cochrane Collaboration's risk of bias. A network meta-analysis within the frequentist model was performed by combining direct and indirect evidence from all available RCTs. The primary outcomes were effectiveness as measured by the Pittsburgh Sleep Quality Index (PSQI) total score and acceptability by the incidence of all-cause drop-out. Results: Twenty-eight RCTs involving 2,391 participants were included. Compared to wait-list, acupuncture (standardized mean difference -4.37, 95% confidence interval -8.53 to -0.12), acupuncture combined with benzodiazepines (-5.20, -9.82 to -0.57), behavioral therapy (-10.44, -17.31 to -3.58), benzodiazepines (-4.28, -8.45 to -0.11), benzodiazepines combined with cognitive behavioral therapy (CBT) (-7.18, -12.17 to -2.19), and CBT (-4.93, -8.63 to -1.22) showed significant superiority in their effectiveness. No significant comparative superiority or inferiority was found in terms of acceptability. Conclusions: In terms of effectiveness as indicated by the PSQI total score, compared to wait-list, superior benefits were observed for acupuncture, acupuncture combined with benzodiazepines, behavioral treatment, benzodiazepines, benzodiazepines combined with CBT, and CBT. Importantly, combined treatments, including benzodiazepines combined with CBT or with acupuncture, were generally superior to other monotherapies. In terms of acceptability, there was not enough data to draw conclusions. However, most RCTs included had methodological problems related to the lack of blinding procedure, suggesting a risk of effect size overestimation. Registration: CRD42019145518.

Validation of the Core Seven-Emotions Inventory - short form.

BACKGROUND: This study aimed to evaluate the reliability and validity of short form of the Core Seven Emotions Inventory (CSEI-s) scale. METHODS: The participants were third-grade Korean Medicine University students As with the original CSEI, the scales in the short form (CSEI-s) were composed of seven factors and consisted of 28 items in total. The internal consistency coefficient was calculated, and a confirmatory factor analysis was conducted to verify the reliability of the short form scale. Finally, to verify the validity of the abbreviated scale, a correlation analysis with the abbreviated scale and the CSEI-s scale was conducted. RESULTS: A 178 among 200 initial participants were included in the analysis (mean age: 24.5 years). The results of the exploratory factor analysis made from the 28 items of the seven factors of the CSEI-s showed that the factor loadings were as high as 0.64-0.89, excluding the tenth item of fear (0.52), and the model fit also had a good confirmatory factor with the analysis result. The results of the reliability verification showed that the Cronbach α values of all seven subscales of the short-form CSEI scale were 0.7 or higher, and the overall reliability was 0.83. A factor analysis revealed that the factor loadings were adequate, and their reliability and validity were confirmed for the CSEI-s scale, making it applicable to measuring the core seven emotions of patients in clinical practice. CONCLUSION: CSEI-s scale may apply to measure core emotions of the patient in a clinical setting.

Clinical effects of mindfulness meditation and cognitive behavioral therapy standardized for insomnia: A protocol for a systematic review and meta-analysis.

INTRODUCTION: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of mindfulness meditation and cognitive behavioral therapy programs as a psychological intervention for insomnia disorders. METHODS AND ANALYSIS: We will search the following 11 electronic databases without language or publication status restrictions: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and PsycARTICLES. Furthermore, we will also search 5 Korean-language databases (Oriental Medicine Advanced Searching Integrated System, Korean studies Information Service System, Research Information Service System, Korean Medical Database, and Korea Citation Index). The study selection and data extraction will be performed independently by 2 authors. The study quality assessment and evaluation of the quality of evidence for the main findings will be performed independently by 2 authors using the Cochrane tool for assessing risk of bias and predefined criteria (the Grading of Recommendations Assessment, Development, and Evaluation approach). Data synthesis and analysis will be performed using RevMan Version 5.3. Data will be synthesized by either a fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. If any plan for documenting important protocol amendments changes, the researchers will have a revision agreement and then register the modification in the International Prospective Register of Systematic Reviews (PROSPERO). ETHICS AND DISSEMINATION: Ethical approval will not be required because individual patient data are not included and because this protocol is for a systematic review. The findings of this systematic review will be disseminated through conference presentations.PROSPERO registration number: CRD42018111217.

Meditation-based clinical study to determine the correlation of quantitative electroencephalogram (qEEG) and 24-hour EEG activity.

BACKGROUND: The heart continuously transmits information to the cerebrum during each pulse, and influences information processing such as perception, cognition, and emotion, which are processed in the cerebrum. This is the basis for the theory of oriental medicine widely used in psychiatric medicine and clinical practice, so-called Simjushinji (heart and brain) theory, that the heart controls the mind. The present study aims to analyze the correlation between heart and brain function by 24-hour active electrocardiogram and quantitative electroencephalogram (EEG) measurement under meditation. METHODS: This randomized, controlled, assessor-blinded, 2-armed, parallel, multicenter clinical trial will analyze a total of 50 subjects, including 25 each for the test group and the active control group. Subjects will be randomly allocated to the test group (performing resource mindfulness) and the control group (performing stress mindfulness) in a 1:1 ratio. The clinical trial consists of 3 stages. The first and third stages are stable states. The second stage is divided into the test and active comparator groups. Quantitative EEG (qEEG) measurements at stages 1 and 3 will be recorded for 10 minutes; measurements at stage 2 will be recorded for 20 minutes with the eyes closed. The 24-hour Holter Monitoring and heart rate variability will be evaluated at each stage. Before the beginning of stage 3, subjects will complete the questionnaires. The primary outcome will be analyzed by independent t tests of both groups. DISCUSSION: Scientific studies based on clinical epistemology are expected to serve as a basis for sustainable medical services in the field of psychiatric medicine in Korea. HRV, blood pressure index, and biometric index in qEEG, as determined by 24-hour Holter monitoring, will complement quantitative biomarkers and be useful in various fields.