Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD we...Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD were allocated to either moxibustion robot(MR)group(35 cases)or manual moxibustion(MM)group(35 cases)using computer-generated randomization.One acupoint Guanyuan(CV 4)was selected to receive moxa heat stimulation.Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively(once a day,5 days a session)and received another 3 menstrual cycles follow-up.The degree of pain was evaluated by short-form McGill pain questionnaire(SF-MPQ)and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale(CMSS).The safety was measured by the occurrence rate of adverse events(AEs),including burns(blisters,red and swollen),itching,bowel changes,menstrual cycle disorder,menorrhagia and fatigue,etc.Results A total of 62 patients completed the trial,32 in MR group and 30 in MM group.Compared with baseline,scores of SF-MPQ and CMSS significantly decreased in both groups(P<0.05),and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles(P>0.05).The total occurrence rate of AEs in MR group was 2.1%,which was significantly lower than MM group(7.2%,P<0.05).Conclusions MR has the same effect as MM at SF-MPQ and CMSS in patients with PD.However,MR is safer than MM(Trial registration No.ChiCTR1800018236).展开更多
AIM:To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.METHODS:This British multi-site study recruitedseventeen symptomatic adult patients with r...AIM:To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.METHODS:This British multi-site study recruitedseventeen symptomatic adult patients with refractory strictures.Patients were randomisedus in gamulticentre,blinded assessor design,comparing a biodegradable stent(BS)with endoscopic dilatation(ED).The primary endpoint was the average dysphagia score during the first 6 mo.Secondary endpoints included repeat endoscopic procedures,quality of life,and adverse events.Secondary analysis included follow-up to 12 mo.Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values.Nonparametric tests were used.RESULTS:Although both groups improved,the average dysphagia scores for patients receiving stents were higher after 6 mo:BS-ED 1.17(95%CI:0.63-1.78)P=0.029.The finding was robust under different estimation methods.Use of additional endoscopic procedures and quality of life(QALY)estimates were similar for BS and ED patients at 6 and12 mo.Concomitant use of gastrointestinal prescribed medication was greater in the stent group(BS 5.1,ED 2.0 prescriptions;P<0.001),as were related adverse events(BS 1.4,ED 0.0 events;P=0.024).Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment.The oesophageal tract has somatic sensitivity and the process of the stent dissolving,possibly unevenly,might promote discomfort or reflux.CONCLUSION:Stenting was associated with greater dysphgia,co-medication and adverse events.Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology.展开更多
Background: Previous studies have demonstrated psychosocial and physical benefit from exercise for older men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa). To date, different intervention d...Background: Previous studies have demonstrated psychosocial and physical benefit from exercise for older men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa). To date, different intervention delivery methods have not been assessed. This study compared the effect of group-based exercise (GBE) to personal training (PT) in men undergoing ADT for PCa. Methods: 13 participants (mean age = 68.2, SD = 7.2) were randomly assigned to GBE or PT for 8 weeks. Participants exercised for 60 minutes three times per week at a moderate-vigorous intensity. Results: 10 participants completed the intervention. At post-intervention, the PT group improved: fatigue, systolic BP, waist circumference, body fat percentage, and maximal leg strength;participants in the GBE group improved leg strength. At 8 weeks, maximal upper body strength in the PT group was greater than the GBE group. There were no adverse events associated with moderate-high intensity training in this population of older men. Conclusion: PT may be more efficacious than GBE in improving several physical fitness outcomes and fatigue in men with PCa who are androgen deprived. Due to the small sample size and attrition, these results require cautious interpretation and confirmation from adequately powered trials.展开更多
The purpose of this study was to pilot an innovative and supported intervention for individuals with a stroke. A pilot control trial with qualitative interviews was undertaken within a university- community setting. T...The purpose of this study was to pilot an innovative and supported intervention for individuals with a stroke. A pilot control trial with qualitative interviews was undertaken within a university- community setting. Thirteen individuals who had experienced a stroke for periods of least 6 months (6 male, average 71 years) were assigned to the intervention group and 7 individuals (2 male, average age 67.9 years) assigned to the control group. Eight individuals from the intervention group completed a single interview. The procedures that related to recruitment and retention and data collection methods were considered. Outcome measures including;self-efficacy, falls self-efficacy and group membership, for both groups were taken at baseline, 11 weeks, 22 weeks. There was an additional assessment at 52 weeks for the intervention group. The structured interview was designed to focus on experiences of the intervention. Self-efficacy remained stable across time for both groups. An improvement in falls self-efficacy was noted in the intervention group at 11 weeks. Consistent improvement (from baseline) was observed in the identity scale across the 52 weeks. Qualitative data provided additional findings related to identity and confidence. Details considering recruitment and retention are also provided. This pilot study provided data that can be used for a further full-scale trial to be considered.展开更多
针对智能航电系统在非线性耦合运行场景下产生的预期功能安全(safety of the intended functionality,SOTIF)问题,提出一种将系统理论过程分析(systematic theory process analysis,STPA)与决策试验与评价实验法(decision-making trial ...针对智能航电系统在非线性耦合运行场景下产生的预期功能安全(safety of the intended functionality,SOTIF)问题,提出一种将系统理论过程分析(systematic theory process analysis,STPA)与决策试验与评价实验法(decision-making trial and evaluation laboratory,DEMATEL)相结合的致因分析框架。首先,在定义系统级危险的基础上构建安全控制结构,识别其不安全控制行为并提取与智能化缺陷相关的STPA致因要素。接下来,引入毕达哥拉斯模糊加权平均算子和闵可夫斯基距离对传统DEMATEL方法进行优化,专家根据控制反馈回路对致因要素进行评价并计算其中心度与原因度。最后,分析STPA致因要素与SOTIF致因属性之间的映射关系,给出关键致因要素的风险减缓措施。以单一飞行员驾驶(single-pilot operation,SPO)模式下的虚拟驾驶员助理系统为例说明了所提方法的可行性与有效性。研究结果表明,改进的STPA-DEMATEL方法可以有效识别关键致因要素,且能够克服专家评价的模糊性与不确定性,为智能航电系统的安全性设计提供了参考依据。展开更多
Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the...Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures;2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation;3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.展开更多
基金Supported by Traditional Chinese Medicine Administration of Sichuan Province(No.2018KF013)Health Commission of Sichuan Province(No.2000IF10)Self-determined Project of Sichuan University(No.2016CDDY-S19-SCU)。
文摘Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD were allocated to either moxibustion robot(MR)group(35 cases)or manual moxibustion(MM)group(35 cases)using computer-generated randomization.One acupoint Guanyuan(CV 4)was selected to receive moxa heat stimulation.Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively(once a day,5 days a session)and received another 3 menstrual cycles follow-up.The degree of pain was evaluated by short-form McGill pain questionnaire(SF-MPQ)and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale(CMSS).The safety was measured by the occurrence rate of adverse events(AEs),including burns(blisters,red and swollen),itching,bowel changes,menstrual cycle disorder,menorrhagia and fatigue,etc.Results A total of 62 patients completed the trial,32 in MR group and 30 in MM group.Compared with baseline,scores of SF-MPQ and CMSS significantly decreased in both groups(P<0.05),and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles(P>0.05).The total occurrence rate of AEs in MR group was 2.1%,which was significantly lower than MM group(7.2%,P<0.05).Conclusions MR has the same effect as MM at SF-MPQ and CMSS in patients with PD.However,MR is safer than MM(Trial registration No.ChiCTR1800018236).
基金Supported by NIHR RfPB programme,No.PB-PG-1208-17025
文摘AIM:To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.METHODS:This British multi-site study recruitedseventeen symptomatic adult patients with refractory strictures.Patients were randomisedus in gamulticentre,blinded assessor design,comparing a biodegradable stent(BS)with endoscopic dilatation(ED).The primary endpoint was the average dysphagia score during the first 6 mo.Secondary endpoints included repeat endoscopic procedures,quality of life,and adverse events.Secondary analysis included follow-up to 12 mo.Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values.Nonparametric tests were used.RESULTS:Although both groups improved,the average dysphagia scores for patients receiving stents were higher after 6 mo:BS-ED 1.17(95%CI:0.63-1.78)P=0.029.The finding was robust under different estimation methods.Use of additional endoscopic procedures and quality of life(QALY)estimates were similar for BS and ED patients at 6 and12 mo.Concomitant use of gastrointestinal prescribed medication was greater in the stent group(BS 5.1,ED 2.0 prescriptions;P<0.001),as were related adverse events(BS 1.4,ED 0.0 events;P=0.024).Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment.The oesophageal tract has somatic sensitivity and the process of the stent dissolving,possibly unevenly,might promote discomfort or reflux.CONCLUSION:Stenting was associated with greater dysphgia,co-medication and adverse events.Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology.
文摘Background: Previous studies have demonstrated psychosocial and physical benefit from exercise for older men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa). To date, different intervention delivery methods have not been assessed. This study compared the effect of group-based exercise (GBE) to personal training (PT) in men undergoing ADT for PCa. Methods: 13 participants (mean age = 68.2, SD = 7.2) were randomly assigned to GBE or PT for 8 weeks. Participants exercised for 60 minutes three times per week at a moderate-vigorous intensity. Results: 10 participants completed the intervention. At post-intervention, the PT group improved: fatigue, systolic BP, waist circumference, body fat percentage, and maximal leg strength;participants in the GBE group improved leg strength. At 8 weeks, maximal upper body strength in the PT group was greater than the GBE group. There were no adverse events associated with moderate-high intensity training in this population of older men. Conclusion: PT may be more efficacious than GBE in improving several physical fitness outcomes and fatigue in men with PCa who are androgen deprived. Due to the small sample size and attrition, these results require cautious interpretation and confirmation from adequately powered trials.
文摘The purpose of this study was to pilot an innovative and supported intervention for individuals with a stroke. A pilot control trial with qualitative interviews was undertaken within a university- community setting. Thirteen individuals who had experienced a stroke for periods of least 6 months (6 male, average 71 years) were assigned to the intervention group and 7 individuals (2 male, average age 67.9 years) assigned to the control group. Eight individuals from the intervention group completed a single interview. The procedures that related to recruitment and retention and data collection methods were considered. Outcome measures including;self-efficacy, falls self-efficacy and group membership, for both groups were taken at baseline, 11 weeks, 22 weeks. There was an additional assessment at 52 weeks for the intervention group. The structured interview was designed to focus on experiences of the intervention. Self-efficacy remained stable across time for both groups. An improvement in falls self-efficacy was noted in the intervention group at 11 weeks. Consistent improvement (from baseline) was observed in the identity scale across the 52 weeks. Qualitative data provided additional findings related to identity and confidence. Details considering recruitment and retention are also provided. This pilot study provided data that can be used for a further full-scale trial to be considered.
文摘针对智能航电系统在非线性耦合运行场景下产生的预期功能安全(safety of the intended functionality,SOTIF)问题,提出一种将系统理论过程分析(systematic theory process analysis,STPA)与决策试验与评价实验法(decision-making trial and evaluation laboratory,DEMATEL)相结合的致因分析框架。首先,在定义系统级危险的基础上构建安全控制结构,识别其不安全控制行为并提取与智能化缺陷相关的STPA致因要素。接下来,引入毕达哥拉斯模糊加权平均算子和闵可夫斯基距离对传统DEMATEL方法进行优化,专家根据控制反馈回路对致因要素进行评价并计算其中心度与原因度。最后,分析STPA致因要素与SOTIF致因属性之间的映射关系,给出关键致因要素的风险减缓措施。以单一飞行员驾驶(single-pilot operation,SPO)模式下的虚拟驾驶员助理系统为例说明了所提方法的可行性与有效性。研究结果表明,改进的STPA-DEMATEL方法可以有效识别关键致因要素,且能够克服专家评价的模糊性与不确定性,为智能航电系统的安全性设计提供了参考依据。
文摘Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures;2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation;3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.
