The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.Items numbered 1., 2., 3., 4a., 4b etc are original CONSORT or CONSORT-NPT (nonpharmacologic treatment) items. Items with Roman numerals (i., ii, iii, iv etc.) are CONSORT-EHEALTH extensions/clarifications.As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Objective: Tripterygium wilfordii Hook F (TwHF) is a widely used and effective treatment for inflammatory diseases. There have been concerns about its toxicity but no adequate synthesis of the evidence for adverse events (AEs). We aimed to undertake a clinically informative, systematic safety profile of TwHF.Methods: We undertook a systematic review and meta-analysis of experimental studies and observational studies. We searched electronic databases and conference abstracts. Safety outcomes were rates of common AEs.Results: We screened 4137 abstracts for eligibility and included 594 studies in the analysis. The overall incidence of AEs was 26.7% (95% CI 24.8%, 28.8%) in 23,256 TwHF users. The estimates did vary markedly when stratified by specific study types. The incidence of gastrointestinal symptoms, adverse reproductive outcomes, adverse skin reactions, hematologic events and cardiovascular events were 13.3% (95% CI 11.9%, 14.9%), 11.7% (95% CI 10.3%, 13.3%), 7.8% (95% CI 6.3–9.5%), 6.5% (95% CI 5.7–7.4 %) and 4.9% (95% CI 1.6 %, 14.3 %), respectively. The prevalence of irregular menstruation (IM) was increased in patients taking TwHF compared with those given control (odds ratio [OR] 4.65, 95% CI 3.08 to 7.03). TwHF use has lower risk of weight gain (OR 0.12 [95% CI 0.04 to 0.39]) and hair loss (OR 0.37 [95% CI 0.18 to 0.78]). Furthermore, long-term aspirin use (>6 months) has a higher AEs incidence (31.0% [95% CI 24.5%–38.5%]).Conclusion: Our findings suggest that more than one in four patients who were taking TwHF had experienced AEs. A clear need exists for improved understanding of contributing risk factors, as well as of prevention and management strategies to improve patients' tolerance for TwHF.
Background Telehealth and online health information provide patients with increased access to healthcare services and health information in chronic disease management of older patients with chronic diseases, addressing the challenge of inadequate health resources and promoting active and informed participation of older patients in chronic disease management. There are few qualitative studies on the application of telehealth and online health information to chronic disease management in older patients. Chronic obstructive pulmonary disease is one of the most common chronic diseases in older adults. Telehealth is widely used in the management of chronic obstructive pulmonary disease. The purpose of this study was to explore the perceptions and experiences of older patients and healthcare providers in the application of telehealth and online health information to chronic disease management of chronic obstructive pulmonary disease. Methods A qualitative descriptive study with data generated from 52 individual semi-structured interviews with 29 patients [Law of the People’s Republic of China on the protection of the rights and interests of older people (2018 Revised Version) = >60 years old] with chronic obstructive pulmonary disease and 23 healthcare providers. The inductive thematic analysis method was used for data analysis. Results Four themes and 16 sub-themes were identified in this study. Four themes included: faced with a vast amount of online health information, essential competencies and personality traits ensuring older patients’ participation and sustained use, user experience with the use of technology, being in a complex social context. Conclusion The ability of patients to understand health information should be fully considered while facilitating access to online health information for older patients. The role of health responsibility and user experience in older patients’ participation and sustained use of telehealth and online health information needs to be emphasised. In addition, the complex social context is a determining factor to be considered, particularly the complex impact of a reliance on offspring and social prejudice on the behaviour of older adults using telehealth and online health information.
Objective Fibromyalgia is a poorly understood pain syndrome. Repetitive transcranial magnetic stimulation is a noninvasive brain stimulation therapy and is commonly applied for the management of fibromyalgia. However, controversy regarding its efficacy remains. Therefore, a meta-analysis was conducted to evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for fibromyalgia syndrome. Method Four medical databases and one physiotherapy database were screened for randomized controlled trials. A systematic review and meta-analysis was performed. Numerical Pain Rating Scale (NPRS), Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale (HADS) anxiety score, Pain Catastrophizing Scale (PCS), Fatigue Severity Scale (FSS), Short Form-36 general health survey mental score, and Fibromyalgia Impact Questionnaire (FIQ) were set as outcome measures. Results Analysis of 14 studies and 433 participants indicated that rTMS exerted more favorable effects on the NPRS than sham rTMS after treatment (standardized mean difference = −0.49, 95% confidence interval = −0.86 to − 0.13, P = 0.008, I2 = 68%) and FIQ (standardized mean difference = −0.50, 95% confidence interval = −0.75 to − 0.25, P = 0.0001, I2 = 28%). However, the BDI, FSS, PCS, mood index, and HADS scores showed no significant difference compared with sham rTMS after treatment. The mean methodological quality of included studies was an acceptable score of 8.5 based on the PEDro scale, suggesting the validity of our conclusions. Conclusion This study demonstrated that rTMS relieved pain and enhanced quality of life of patients with fibromyalgia; however, it did not improve anxiety, depression, and other symptoms based on current reports.
ObjectiveAlthough Traditional Chinese Yijinjing Qigong Exercise (YJJQE) as mind–body intervention is popularly used among adults to ameliorate depressive symptoms in China, no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with poststroke depression (PSD). This study aims to explore the clinical efficacy and the neurological and psychiatric mechanism in brain network functional connectivity underlying electroencephalography (EEG).Materials and methodsA total of 60 patients, diagnosed with mild PSD, were randomly (1:1) assigned to YJJQE group (n = 30) and control group of routine segmental rehabilitation training group (n = 30) for a 60-min exercise session once a day for 3 weeks. All outcome measures were collected at baseline and 3-weeks ending intervention. The primary outcome was the 24-item Hamilton Depression Scale (HAMD-24) score, evaluation at more time points for 1 month of follow-up. The secondary outcomes were EEG data in four frequency domains (δ, θ, α, and β), global efficiency (GE), local efficiency (LE), GE/LE curve [areas under the curve (AUC)], Phase Lag Index (PLI), (HAMD-24) Score and EEG correlation analysis.ResultsAll patients showed no significant differences in baseline data. After 3 weeks and 1 month of follow-up, the YJJQE group demonstrated significant decreasing changes compared to the control group on the HAMD-24 scores (p < 0.001). Furthermore, the YJJQE group also showed a significant reduction in θ wave, and an increase in both GE and LE. Compared to the control group, the YJJQE Qigong group showed significantly greater functional connectivity in the δ, θ, and β frequency bands in the brain network of the degree of phase synchronization (p < 0.001). HAMD-24 Score and EEG correlation analysis negative correlation in the Qigong group θ wave (p < 0.001).ConclusionOur findings demonstrated that YJJQE is estimated to effectively alleviate the depressed mood of patients with PSD by promoting the efficiency in information transmission of network functional connectivity and its integration ability in different brain regions. Therefore, the YJJQE would be useful as a non-pharmacological treatment to prevent PSD.Clinical trial registration[http://www.chictr.org.cn/showproj.aspx?proj=55789], identifier [ChiCTR2000035588].
Background Knee osteoarthritis (OA) is a leading cause of global disability. According to current guidelines, exercise is the most recommended and important non-surgical treatment for knee OA. However, the best type of exercise for this condition remains unclear. Evidence has shown that traditional Chinese exercises may be more effective. Therefore, the current prospective, two-armed, single-center randomized controlled trial (RCT) aimed to identify an effective physiotherapy for knee OA. Methods/design In total, 114 patients with painful knee OA will be recruited from the orthopedic outpatient department of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital. To compare the therapeutic effect of two different home-based exercise programs, the participants will be randomly assigned into the experimental group (leg swing exercise) or the control group (quadriceps strengthening exercise). Each participant in both groups will be required to attend five individual sessions with a physiotherapist who will teach the exercise program and monitor progress. Participants will be instructed to perform the exercises at home every day for 12 weeks. Clinical outcomes will be assessed at baseline and 12 and 24 weeks after starting the intervention. The primary outcomes are average overall knee pain and physical function in daily life. The secondary outcomes include other measures of knee pain, physical function, patient-perceived satisfactory improvement, health-related quality of life, physical activity and performance, muscle strength of the lower limb, and adherence. Discussion This study will provide more evidence on the effects of traditional Chinese exercise on improving physical function and relieving joint pain among patients with knee OA. If proven effective, leg swing exercise can be used as a non-surgical treatment for knee OA in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000039005. Registered on 13 October 2020.
Background The close relationship between pain and mental health problems is well-known, and psychological intervention can provide an effective alternative to medication-based pain relief. However, previous studies on the connection between pain and psychological problems, the findings thus far have been inconclusive, limiting the potential for translating psychological interventions into clinical practice. To complement the gap, this study utilized genetic data and Mendelian randomization (MR) to examine the potential relationship between pain in different parts and common mental disorders. Methods Based on the instrumental variables selected from the Genome-wide association study summary statistics of localized pain and mental disorders, we conducted bidirectional two-sample MR analyses to infer bidirectional causal associations between pain and mental disorders. The inverse-variance weighted MR method and MR-Egger were used as the primary statistical method according to the horizontal pleiotropy and heterogeneity level. We reported the odds ratio to infer the causal effect between pain and mental disorders. F statistic was calculated to measure the statistical efficacy of the analyses. Results Insomnia is causally related to the genetic susceptibility of multisite pain including head (OR = 1.09, 95% CI: 1.06–1.12), neck/shoulder (OR = 1.12, 95% CI: 1.07–1.16), back (OR = 1.12, 95% CI: 1.07–1.18) and hip (OR = 1.08, 95% CI: 1.05–1.10). Reversely, headache (OR = 1.14, 95% CI: 1.05–1.24), neck/shoulder pain (OR = 1.95, 95% CI: 1.03–3.68), back pain (OR = 1.40, 95% CI: 1.22–1.60), and hip pain (OR = 2.29, 95% CI: 1.18–4.45) promote the genetic liability of insomnia. Depression is strongly associated with the predisposition of multisite pain including headache (OR = 1.28, 95% CI: 1.08–1.52), neck/shoulder pain (OR = 1.32, 95% CI: 1.16–1.50), back pain (OR = 1.35, 95% CI: 1.10–1.66) and stomach/abdominal pain (OR = 1.14, 95% CI: 1.05–1.25), while headache (OR = 1.06, 95% CI: 1.03–1.08), neck/shoulder (OR = 1.09, 95% CI: 1.01–1.17), back (OR = 1.08, 95% CI: 1.03–1.14), and stomach/abdominal pain (OR = 1.19, 95% CI: 1.11–1.26) are predisposing factors for depression. Additionally, insomnia is associated with the predisposition of facial, stomach/abdominal, and knee pain, anxiety was associated with the predisposition of neck/shoulder and back pain, while the susceptibilities of hip and facial pain are influenced by depression, but these associations were unidirectional. Conclusions Our results enhance the understanding of the complex interplay between pain and mental health and highlight the importance of a holistic approach to pain management that addresses both physical and psychological factors.
Objective: To understand the perceptions and experiences of older patients with chronic obstructive pulmonary disease (COPD) and healthcare professionals (HCPs) regarding shared decision-making in pulmonary rehabilitation (PR). Design: A qualitative study using single, semi-structured interviews, and thematic analysis. Setting: Face-to-face interviews were conducted in the Jiangnan University, in hospital and in patients’ homes. Participants: Twenty-two older patients with COPD and 29 HCPs. Methods: An initial codebook and semi-structured interview guide were developed based on the shared decision-making 3-circle conceptual model. Thematic analysis was used to analyze data. Results: The study identified 10 themes that describe the perceptions and experiences of patients and HCPs involved in PR decision-making: (1) patients’ confidence, (2) patients’ perceptions of the cost-benefit of decisions, (3) patients’ perceived stress about the consequences of decision-making, (4) HCPs’ perceived stress on shared decision-making, (5) cognitive biases of patients toward illness and rehabilitation, (6) shared decision-making as a knowledge gap, (7) the knowledge gap between patients and HCPs, (8) authority effect, (9) family support, (10) human resources. These themes were then divided into three groups according to their characteristics: (1) the feelings of the participants, (2) knowledge barriers, and (3) support from the social system. Conclusion: Patients and HCPs described their negative perceptions and experiences of participating in decision-making in PR. The implementation of shared decision-making in PR is currently limited; therefore, health education for patients and families should be strengthened and a training system for HCPs in shared decision-making should be established.
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