RCT (randomised controlled trial)

  • 文章类型: Journal Article
    根据腕踝针(WAA)的原理,我们的研究小组开发了一种便携式设备,用于WAA点压缩,称为指压腕踝带(AWA)。本研究旨在评估AWA缓解原发性痛经相关疼痛的疗效。
    单盲,随机临床试验于2019年4月1日至2019年12月31日进行.从上海中医药大学招募78例原发性痛经患者。所有参与者在月经的第一天治疗30分钟。AWA小组的参与者使用AWA,其内侧装有尖端压缩组件,而非指压腕踝针(NAWA)组的参与者使用NAWA,内部尖端按压部件被移除。主要结果是基线和随机分组后30分钟之间的视觉模拟量表(VAS)评分差异。
    共有78名18至30岁的参与者被纳入意向治疗分析。在干预的每个时间点,AWA组的VAS评分(平均值[标准差])均显着低于NAWA组(5分钟:95%CI,[-1.27to-0.68],p<0.001;10分钟:95%CI,[-2.34至-1.51],p<0.001;30分钟:95%CI,[-3.74至-2.72],p<0.001)。在AWA组中,16例参与者报告痛经疼痛“明显缓解”,23例没有;他们报告的镇痛平均起效时间为(21.50±3.65)分钟,而NAWA组没有受试者报告疼痛明显缓解。AWA组在干预后两侧的SP9疼痛阈值(平均值[标准差])显着下降,而NAWA组(左:95%CI,[-5.02至-1.81],p<0.001;右:95%CI,[-7.67至-4.24],p<0.001)。两组中CV4时的温度均无明显变化(95%CI,[-0.63至-0.66],p=0.970)。
    该试验证实了我们的假设,即AWA可立即提供镇痛作用。AWA代表了一种有效且安全的非侵入性物理治疗选择,患者可以自行用药以缓解腹痛。
    UNASSIGNED: Drawing on the principles of wrist-ankle acupuncture (WAA), our research team has developed a portable device for WAA point compression, termed the acupressure wrist-ankle strap (AWA). The current study aims to evaluate the efficacy of the AWA in alleviating pain associated with primary dysmenorrhea.
    UNASSIGNED: A single-blind, randomized clinical trial was conducted from April 1, 2019, to December 31, 2019. 78 participants with primary dysmenorrhea were recruited from Shanghai University of Traditional Chinese Medicine. All participants were treated on the first day of menstruation for 30 min. Participants in the AWA group used the AWA, the internal side of which is equipped with a tip compression component, while participants in the non-acupressure wrist-ankle acupuncture(NAWA)group used the NAWA, with the inside tip pressing parts removed. The main outcome was the difference in visual analogue scale (VAS) score between baseline and 30 minutes after randomization.
    UNASSIGNED: A total of 78 participants aged 18 to 30 years were included in the intention-to-treat analyses. The VAS scores (mean [standard deviation]) in the AWA group were significantly lower than those in the NAWA group at each time point of intervention (5 minutes: 95% CI, [-1.27 to -0.68], p < 0.001; 10 minutes: 95% CI, [-2.34 to -1.51], p < 0.001; 30 minutes: 95% CI, [-3.74 to -2.72], p < 0.001). In the AWA group, 16 participants reported \"obvious relief\" of dysmenorrhea pain while 23 did not; the average onset time of analgesia they reported were (21.50 ± 3.65) min, while no subjects in NAWA group reported obvious pain relief. The pain threshold (mean [standard deviation]) at SP9 of both sides in AWA group decreased significantly after intervention that in NAWA group (Left: 95% CI, [-5.02 to -1.81], p < 0.001; Right: 95% CI, [-7.67 to -4.24], p < 0.001). There was no significant change in the temperature at CV4 in either group (95% CI, [-0.63 to -0.66], p = 0.970).
    UNASSIGNED: This trial substantiates our hypothesis that the AWA provides immediate analgesic effects. The AWA represents an effective and safe non-invasive physical therapy option, which patients can self-administer to alleviate abdominal pain.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Clinical Trial Protocol
    BACKGROUND: Colorectal cancer (CRC) is the third most common cancer worldwide, with a median age of 72-75 years at diagnosis. Curative treatment usually involves surgery; if left untreated, symptoms may require emergency surgery. Therefore, most patients will be accepted for surgery, despite of high age or comorbidity. It is known that elderly patients suffer higher risks after surgery than younger patients, in terms of complications and mortality. Assessing frailty and offering frail elderly patients individualized treatment according to the comprehensive geriatric assessment (CGA) and care concept has been shown to improve the outcome for frail elderly patients in other clinical contexts.
    METHODS: This randomized controlled multicentre trial aims to investigate if CGA and care prior to curatively intended surgery for CRC in frail elderly patients will improve postoperative outcome. All patients ≥ 70 years with surgically curable CRC will be screened for frailty using the Clinical Frailty Scale (CFS-9). Frail patients will be offered inclusion. Randomization is stratified for colon or rectal cancer. Patients in the intervention group are, in addition to standard protocol, treated according to CGA and care. This consists of individualized assessments and interventions, established by a multiprofessional team. Patients in the control group are treated according to best known practice as stipulated by Swedish colorectal cancer treatment guidelines, within an enhanced recovery after surgery (ERAS) setting. The primary outcome is 90-day mortality. Secondary outcomes are the length of hospital stay and total number of hospital days within 3 months, discharge destination, 30-day readmission, ADL, safe medication assessment, CFS-9 score, complications, Health-Related Quality of Life (HRQoL) at 2-month follow-up in comparison to baseline measurements, health economical calculations including cost-effectiveness analysis based on costs of hospital care and primary care, mortality and HRQoL at baseline, 2- and 12-month follow-up and all-cause 1-year mortality.
    CONCLUSIONS: The trial is the first of its size and extent to investigate intervention with CGA and care prior to surgery for CRC in frail elderly patients. If this addition proves to be favourable, it could have implications on future care of frail elderly patients with CRC.
    BACKGROUND: ClinicalTrials.gov NCT04358328. Registered on 4 February 2020.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    UNASSIGNED:腹腔镜治疗异位妊娠主要包括腹腔镜输卵管切开术和输卵管切除术。我们旨在评估腹腔镜下输卵管切开和输卵管切除术对输卵管妊娠患者的治疗效果。
    UNASSIGNED:从2000年1月到2022年6月,Cochrane图书馆,Medline,PubMed,WebofScience,EMBASE,并在中国生物医学数据库中搜索了比较腹腔镜下输卵管切开术与输卵管切除术治疗输卵管妊娠.
    UNASSIGNED:将24项随机临床试验(RCT)研究纳入本分析。两组在手术时间和术后住院时间方面无统计学差异,但腹腔镜下输卵管切开术患者的术中出血量少于输卵管切除术。重要的是,腹腔镜下输卵管切开术后自然宫内妊娠率明显高于行输卵管切除术者。此外,腹腔镜下输卵管切开术能更好地保护卵巢储备功能和内分泌功能,为再次妊娠提供有利条件。
    UNASSIGNED:异位输卵管妊娠患者应优先考虑腹腔镜输卵管切开取胚。
    UNASSIGNED: Laparoscopic treatment of ectopic pregnancy mainly includes laparoscopic salpingotomy and salpingectomy. We aimed to assess the therapeutic effect of laparoscopic salpingotomy and salpingectomy on patients with tubal pregnancy.
    UNASSIGNED: From January 2000 through June 2022, the Cochrane Library, Medline, PubMed, Web of Science, EMBASE, and the Chinese Biomedicine Database were searched for studies that compared the therapeutic effect of laparoscopic salpingotomy vs. salpingectomy in the treatment of tubal pregnancy.
    UNASSIGNED: Twenty-four randomized clinical trials (RCTs) studies were incorporated into this analysis. No statistical differences were found between the two groups in terms of operation duration and postoperative hospitalize length, but the volume of intraoperative blood loss in patients with laparoscopic salpingotomy was less than that in salpingectomy. Importantly, the natural intrauterine pregnancy rate after laparoscopic salpingotomy was significantly higher than those who underwent salpingectomy. In addition, laparoscopic salpingotomy can better protect the ovarian reserve function and endocrine function and provide favorable conditions for the second pregnancy.
    UNASSIGNED: Patients with ectopic tubal pregnancy should give priority to laparoscopic salpingotomy for embryo extraction.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool.
    MAGNETIC is a multicentre randomised trial of nebulised magnesium in acute severe asthma, recruiting 508 children from 30 UK sites. Recruiters were asked to grade a list of factors from -3 to +3 depending on whether the factor was perceived as a strong, intermediate or weak barrier (-3 to -1) or facilitator (+1 to + 3), and using (0) if it was thought to be not applicable. Free text responses were invited on strategies applied to counter the identified barriers.
    The commonly identified facilitators were motivation and experience of study teams, effective communication and coordination between teams at site and between sites and the Clinical Trials Unit, the presence of designated research nurses, good trial management, clinical trial publicity, simple inclusion criteria, effective communication with parents and presentation of trial information in a simple and clear manner. The commonly identified barriers were heavy clinical workload, shift patterns of work, Good Clinical Practice (GCP) training, inadequate number of trained staff, time and setting of consent seeking, non-availability of research staff out of hours and parents\' concerns about their child taking an experimental medicine. Having a designated research nurse, arranging GCP training and trial-related training sessions for staff were the most commonly reported interventions.
    This study highlights important generic and trial-specific facilitators and barriers to recruitment to a paediatric trial in the acute setting and provides information on the recruitment strategies or interventions that were applied to overcome these barriers. This information can be very useful in informing the design and conduct of future clinical trials with children, particularly in the acute or emergency setting.
    ISRCTN, ISRCTN81456894 . Registered on 15 November 2007.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

公众号