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  • International randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours – EURO EWING 2012 Protocol
    Trials (IF 1.975) Pub Date : 2020-01-17
    Jennifer Anderton; Veronica Moroz; Perrine Marec-Bérard; Nathalie Gaspar; Valerie Laurence; Javier Martín-Broto; Ana Sastre; Hans Gelderblom; Cormac Owens; Sophie Kaiser; Melissa Fernández-Pinto; Nicola Fenwick; Abigail Evans; Sandra Strauss; Jeremy Whelan; Keith Wheatley; Bernadette Brennan

    Although there have been multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT) and these have been conducted over many years and involved many international cooperative groups, the outcomes for all stages of disease have plateaued. Internationally, the standard treatment of ESFT is not defined, and there is a need to add new agents other than conventional chemotherapy to improve outcomes. This trial will compare two different induction/consolidation chemotherapy regimens: (1) vincristine, ifosfamide, doxorubicin and etoposide (VIDE) induction and vincristine, actinomycin D, ifosfamide or cyclophosphamide, or busulfan and mephalan (VAI/VAC/BuMel) consolidation and (2) vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide (VDC/IE) induction and ifosfamide and etoposide, vincristine and cyclophosphamide, vincristine, actinomycin D and ifosfamide, or busulfan and mephalan (IE/VC/VAI/BuMel) consolidation (randomisation 1, or R1). A second randomisation (R2) will determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome. EURO EWING 2012 is an international, multicentre, phase III, open-label randomised controlled trial. There are two randomisations: R1 and R2. Patients are randomly assigned at two different time points: at entry to the trial (R1) and following local control therapy (R2). The primary outcome measure is event-free survival. The secondary outcome measures include overall survival, adverse events and toxicity, histological response of the primary tumour, response of the primary tumour, regional lymph nodes or metastases (or both), and achievement of local control at the end of treatment. This study will establish which is the “standard regimen” of chemotherapy, taking into account both clinical outcomes and toxicity. This will form the chemotherapy backbone for future interventional studies where we may want to add new targeted agents. It will also determine the role of zoledronic acid in conjunction with the separate EE2008 trial. Any trial in ESFT needs to take into account the rarity of the tumour and consider that international cooperation is needed to provide answers in a timely manner. Registered with EudraCT number 2012-002107-17 on 26 February 2012. Registered with ISRCTN number 54540667 on 4 November 2013.

    更新日期:2020-01-17
  • Shortening antibiotic duration in the treatment of acute cholangitis: rationale and study protocol for an open-label randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-17
    Kentaro Iwata; Asako Doi; Yuichiro Oba; Hiroo Matsuo; Kei Ebisawa; Manabu Nagata; Sho Nishimura; Kenichi Yoshimura; Atsuhiro Masuda; Hideyuki Shiomi; Yuzo Kodama

    Antimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown. Seven to 10 days of antimicrobial therapy are common for the treatment of acute cholangitis, but a recent retrospective cohort study suggested a shorter duration might be effective. A shorter duration of antimicrobial therapy can be beneficial in decreasing the length of hospital stay, improving patients’ quality of life, decreasing adverse effects, and even contributing to a decrease in the occurrence of antimicrobial resistance. We will conduct a multi-centre, open-label, randomized, non-inferiority trial to compare short-course therapy (SCT) with conventional long-course therapy (LCT) in treating patients with acute cholangitis. SCT consists of 5-day intravenous antimicrobial therapy if the patients had clinical improvement, while at least 7 days of intravenous antibiotics will be provided to the LCT group. The primary outcome is clinical cure at 30 days after onset. Patients will be randomly assigned in an open-label fashion. A total sample size of 150 was estimated to provide a power of 80% with a one-sided α level of 2.5% and a non-inferiority margin of 10%. This trial is expected to reveal whether SCT is non-inferior to conventional LCT or not, and may provide evidence that one can shorten the treatment duration for acute cholangitis for the benefit of patients. University Hospital Medical Information Network, UMIN000028382. Registered on 30 August 2017.

    更新日期:2020-01-17
  • Impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults: Study protocol for a randomized controlled single-center trial
    Trials (IF 1.975) Pub Date : 2020-01-16
    Jodi C. McDaniel; Jamie Rausch; Alai Tan

    This trial addresses the global problem of chronic venous leg ulcers (CVLUs), wounds that cause significant infirmity for an estimated 9.7 million people annually, mainly older adults with comorbidities. Advanced therapies are needed because standard topical therapies are often ineffective or yield only short-term wound healing. Thus, we are testing a new oral therapy containing the bioactive elements of fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), for targeting and reducing the high numbers of activated polymorphonuclear leukocytes (PMN) in wound microenvironments that keep CVLUs “trapped” in a chronic inflammatory state. This double-blind RCT will include 248 eligible adults ≥ 55 years of age with CVLUs receiving standard care at a large Midwest outpatient wound clinic. Participants are randomized to two groups: 12 weeks of daily oral therapy with EPA + DHA (1.87 g/day of EPA + 1.0 g/day of DHA) or daily oral therapy with placebo. At 0, 4, 8, and 12 weeks, across the two groups, we are pursuing three specific aims: Aim 1. Compare levels of EPA + DHA-derived lipid mediators, and inflammatory cytokines in blood and wound fluid; Subaim 1a. Compare inflammatory cytokine gene expression by PMNs in blood; Aim 2. Compare PMN activation in blood and wound fluid, and PMN-derived protease levels in wound fluid; Aim 3. Compare reduction in wound area, controlling for factors known to impact healing, and determine relationships with lipid mediators, cytokines, and PMN activation. Subaim 3a. Compare frequency of CVLU recurrence and levels of study variables in blood between the randomly assigned two subgroups (continuing EPA + DHA therapy versus placebo therapy beyond week 12) within the EPA + DHA group with healed CVLUs after 3 months of therapy. Subaim 3b. Compare symptoms of pain at all time points and quality of life at first and last time points across the two groups and two subgroups. This trial will provide new evidence about the effectiveness of EPA + DHA oral therapy to target and reduce excessive PMN activation systemically and locally in patients with CVLUs. If effective, this therapy may facilitate healing and thus be a new adjunct treatment for CVLUs in the aging population. ClinicalTrials.gov, NCT03576989; Registered on 13 June 2018.

    更新日期:2020-01-16
  • Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial
    Trials (IF 1.975) Pub Date : 2020-01-16
    Zhiwei Xiao; Leihao Hu; Jietao Lin; Liming Lu; Xuewu Huang; Xiaoshu Zhu; Chiahshean Teo; Lizhu Lin

    Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response. Due to the lack of high-quality clinical evidence, a randomized placebo-controlled trial is required to assess the efficacy and safety of JPSS. The efficacy and safety of JPSS herbal formula cream will be evaluated through a prospective, randomized, placebo-controlled trial conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. NSCLC patients with CRF will be randomized into two groups at a ratio of 1:1. Each group will receive either 15 g of the oral JPSS herbal formula cream or placebo twice a day from day 6 to day 20 during two courses of paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy. The primary endpoint is the difference in the degree of fatigue between baseline (the day before the start of the intervention) and day 42, which will be assessed by the Revised Piper Fatigue Scale score. The secondary endpoints are quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score. The toxicity of the treatments will also be evaluated at the same time. All outcomes will be measured at baseline, day 6, day 21, and day 42 of the treatment. This randomized trial will investigate the efficacy and safety of JPSS applied for CRF in patients with NSCLC. Chinese Clinical Trial Registry, ChiCTR1900023451. Registered on 28 May 2019.

    更新日期:2020-01-16
  • A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients
    Trials (IF 1.975) Pub Date : 2020-01-16
    Ronald Man Yeung WONG; Wing-Tung HO; Ning TANG; Chi Yin TSO; Wai Kit Raymond Ng; Simon Kwoon-Ho CHOW; Wing-Hoi CHEUNG

    Fractures of the distal radius are one of the most common osteoporotic fractures in elderly men and women. These fractures are a particular health concern amongst the elderly, who are at risk of fragility fractures, and are associated with long-term functional impairment, pain and a variety of complications. This is a sentinel event, as these fractures are associated with a two to four times increased risk of subsequent hip fractures in elderly patients. This is an important concept, as it is well established that these patients have an increased risk of falling. Fall prevention is therefore crucial to decrease further morbidity and mortality. The purpose of this study is to investigate the effect of low-magnitude high-frequency vibration (LMHFV) on postural stability and prevention of falls in elderly patients post distal radius fracture. This is a prospective single-blinded randomized controlled trial. Two hundred patients will be recruited consecutively with consent, and randomized to either LMHFV (n = 100) or a control group (n = 100). The primary outcome is postural stability measured by the static and dynamic ability of patients to maintain centre of balance on the Biodex Balance System SD. Secondary outcomes are the occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events. Outcome assessments for both groups will be performed at baseline (0 month) and at 6 weeks, 3 months and 6 months time points. Previous studies have stressed the importance of reducing falls after distal radius fracture has occurred in elderly patients, and an effective intervention is crucial. Numerous studies have proven vibration therapy to be effective in improving balancing ability in normal patients; However, no previous study has applied the device for patients with fractures. Our study will attempt to translate LMHFV to patients with fractures to improve postural stability and prevent recurrent falls. Positive results would provide a large impact on the prevention of secondary fractures and save healthcare costs. ClinicalTrials.gov, NCT03380884. Registered on 21 December 2017.

    更新日期:2020-01-16
  • Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)
    Trials (IF 1.975) Pub Date : 2020-01-15
    Emma Lidington; Sophie E McGrath; Jillian Noble; Susannah Stanway; Amanda Lucas; Kabir Mohammed; Winette van der Graaf; Olga Husson

    There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination. The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019. 

    更新日期:2020-01-15
  • High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)
    Trials (IF 1.975) Pub Date : 2020-01-15
    Nagy A. Mekhail; Charles E. Argoff; Rod S. Taylor; Christian Nasr; David L. Caraway; Bradford E. Gliner; Jeyakumar Subbaroyan; Elizabeth S. Brooks

    Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus. Neither pharmacological treatments nor low-frequency spinal cord stimulation (SCS) has provided significant and long-term pain relief for patients with PDN. This study aims to document the value of 10-kHz SCS in addition to conventional medical management (CMM) compared with CMM alone in patients with refractory PDN. In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10-kHz SCS combined with CMM or CMM alone after appropriate institutional review board approvals and followed for 24 months. Key inclusion criteria include (1) symptoms of PDN for at least 12 months, (2) average pain intensity of at least 5 cm—on a 0- to 10-cm visual analog scale (VAS)—in the lower limbs, and (3) an appropriate candidate for SCS. Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3 cm on VAS in the upper limbs or both. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. The primary endpoint comparing responder rates (≥50% pain relief) and safety rates between the treatment groups will be assessed at 3 months. Several secondary endpoints will also be reported on. Enrollment commenced in 2017 and was completed in 2019. This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM. ClincalTrials.gov identifier: NCT03228420 (registered 24 July 2017).

    更新日期:2020-01-15
  • The cost-effectiveness of specialized nursing interventions for people with Parkinson’s disease: the NICE-PD study protocol for a randomized controlled clinical trial
    Trials (IF 1.975) Pub Date : 2020-01-15
    Danique L. M. Radder; Herma H. Lennaerts; Hester Vermeulen; Thies van Asseldonk; Cathérine C. S. Delnooz; Rob H. Hagen; Marten Munneke; Bastiaan R. Bloem; Nienke M. de Vries

    Current guidelines recommend that every person with Parkinson’s disease (PD) should have access to Parkinson’s disease nurse specialist (PDNS) care. However, there is little scientific evidence of the cost-effectiveness of PDNS care. This hampers wider implementation, creates unequal access to care, and possibly leads to avoidable disability and costs. Therefore, we aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS compared with usual care (without PDNS) for people with PD in all disease stages. To gain more insight into the deployed interventions and their effects, a preplanned subgroup analysis will be performed on the basis of disease duration (diagnosis < 5, 5–10, or > 10 years ago). We will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with PD who have not been treated by a PDNS over the past 2 years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to receive either care by a PDNS (who works according to a recent guideline on PDNS care) or usual care. We will use two co-primary outcomes: quality of life (measured with the Parkinson’s Disease Questionnaire-39) and motor symptoms (measured with the Movement Disorders Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale part III). Secondary outcomes include nonmotor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden, and coping skills. Data will be collected after 12 months and 18 months by a blinded researcher. A healthcare utilization and productivity loss questionnaire will be completed every 3 months. The results of this trial will have an immediate impact on the current care of people with PD. We hypothesize that by offering more patients access to PDNS care, quality of life will increase. We also expect healthcare costs to remain equal because increases in direct medical costs (funding additional nurses) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care will be warranted. ClinicalTrials.gov, NCT03830190. Registered February 5, 2019 (retrospectively registered).

    更新日期:2020-01-15
  • CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-15
    Rob Coleman; Janet Brown; Emma Rathbone; Louise Flanagan; Amber Reid; Jessica Kendall; Sacha Howell; Chris Twelves; Carlo Palmieri; Anjana Anand; Iain MacPherson; Sarah Brown

    A substantial proportion of breast cancer patients develop metastatic disease, with over 450,000 deaths globally per year. Bone is the most common first site of metastatic disease accounting for 40% of all first recurrence and 70% of patients with advanced disease develop skeletal involvement. Treatment of bone metastases currently focusses on symptom relief and prevention and treatment of skeletal complications. However, there remains a need for further treatment options for patients with bone metastases. Combining systemic therapy with a bone-targeted agent, such as radium-223, may provide an effective treatment with minimal additional side effects. CARBON is a UK-based, open-label, multi-centre study which comprises an initial safety phase to establish the feasibility and safety of combining radium-223 given on a 6-weekly schedule in combination with orally administered capecitabine followed by a randomised extension phase to further characterise the safety profile and provide preliminary estimation of efficacy. The CARBON study is important as the results will be the first to assess radium-223 with chemotherapy in advanced breast cancer. If the results find acceptable rates of toxicity with a decrease in bone turnover markers, further work will be necessary in a phase II/III setting to assess the efficacy and clinical benefit. ISRCTN, ISRCTN92755158, Registered on 17 February 2016.

    更新日期:2020-01-15
  • Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial
    Trials (IF 1.975) Pub Date : 2020-01-15
    Celia A. J. Michielsens; Nadine Boers; Nathan den Broeder; Mark H. Wenink; Aatke van der Maas; Elien A. M. Mahler; Michelle L. M. Mulder; Désirée van der Heijde; Frank H. J. van den Hoogen; Lise M. Verhoef; Alfons A. den Broeder

    Tumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). However, these drugs come with some disadvantages such as adverse events, practical burden for patients and high costs. Dose optimisation of TNFi after patients have reached low disease activity (LDA) has been shown feasible and safe in rheumatoid arthritis (RA). However, data on TNFi dose optimisation in PsA and axSpA are scarce, especially pragmatic, randomised strategy studies. We developed an investigator-driven, pragmatic, open-label, randomised, controlled, non-inferiority trial (DRESS-PS) to compare the effects of a disease activity-guided treat-to-target strategy with or without a tapering attempt in patients with SpA (PsA and axSpA combined), ≥ 16 years of age, who are being treated with TNFi, and have had at least 6 months of low disease activity. The primary outcome is the percentage of patients in LDA after 12 months of follow up. Patients are assessed at baseline, 3, 6, 9, and 12 months of follow up. Bayesian power analyses with a weakened prior based on a similar study performed in RA resulted in a sample size of 95 patients in total. More knowledge on disease activity-guided treatment algorithms would contribute to better treatment choices and cost savings and potentially decrease the risk of side effects. In this article we elucidate some of our design choices on TNFi dose optimisation and its clinical and methodological consequences. Dutch Trial Register, NL6771. Registered on 27 November 2018 (CMO NL66181.091.18, 23 October 2018).

    更新日期:2020-01-15
  • Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial
    Trials (IF 1.975) Pub Date : 2020-01-15
    Elizabeth A. O’Connor; William M. Vollmer; Amanda F. Petrik; Beverly B. Green; Gloria D. Coronado

    Colorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, the effect of mailed FIT kits may differ across important subpopulations. The goal of the current study was to examine sociodemographic and health-related factors that moderate the effect of an intervention of automated direct mail of FIT kits at health clinics serving low-income populations. This study is a secondary analysis of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study, a cluster-randomized pragmatic trial to increase uptake of CRC screening in patients seen at federally qualified health centers. The intervention involved tools embedded in the electronic medical records to enable participating clinics to mail FIT kits and related materials to eligible participants. We examined the rate of FIT completion by potential moderating characteristics using electronic health record data supplemented by the American Community Survey and the Centers for Medicare & Medicaid Services Geographic Variation datasets, linked via geocoding to patients’ addresses. All patients aged 50–75 seen in participating health clinics who were eligible for CRC screening were included. Although not always statistically significant, we saw a consistent pattern of increased FIT return rates among intervention participants compared to control participants across all subgroups studied, with incidence rate ratios (IRRs) generally ranging from 1.25 to 1.50. FIT completion in the intervention group ranged from 15 and 20% across subpopulations, typically three to six percentage points higher than the control group participants. The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00). Response to a mailed FIT intervention was generally consistent across a wide range of individual and neighborhood-level patient characteristics, including typically underserved patients and those in low-resource communities. ClinicalTrials.gov, NCT01742065. Registered on 5 December 2012.

    更新日期:2020-01-15
  • A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards
    Trials (IF 1.975) Pub Date : 2020-01-15
    Nick Daneman; Asgar H. Rishu; Ruxandra Pinto; Yaseen Arabi; Emilie P. Belley-Cote; Robert Cirone; Mark Downing; Deborah J. Cook; Richard Hall; Shay McGuinness; Lauralyn McIntyre; John Muscedere; Rachael Parke; Steven Reynolds; Benjamin A. Rogers; Yahya Shehabi; Phillip Shin; Richard Whitlock; Robert A. Fowler

    The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards. We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients. A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1–4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients. It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results. Clinicaltrials.gov, NCT02917551. Registered on September 28, 2016.

    更新日期:2020-01-15
  • Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial
    Trials (IF 1.975) Pub Date : 2020-01-14
    Raine Sihvonen; Roope Kalske; Martin Englund; Aleksandra Turkiewicz; Pirjo Toivonen; Simo Taimela; Teppo L. N. Järvinen

    The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out. ClinicalTrials.gov, NCT00549172 (Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear). Registered on 25 October 2007 (NCT00549172). ClinicalTrials.gov, NCT01052233 (Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear). Registered on 20 January 2010.

    更新日期:2020-01-15
  • Efficacy of compatible acupoints and single acupoint versus sham acupuncture for functional dyspepsia: study protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-14
    Le Guo; Xin Huang; Li-Juan Ha; Jing-Zhou Zhang; Jia Mi; Ping-Hui Sun; Xi-Ying Han; Ying Wang; Jing-Lin Hu; Fu-Chun Wang; Tie Li

    Acupoint selection is a key factor in the treatment of diseases and has not been well studied. The aim of this trial is to explore the differences in efficacy between compatible acupoints and a single acupoint for patients with functional dyspepsia (FD). This randomized controlled trial will be conducted in the First Affiliated Hospital of Changchun University of Chinese Medicine in China. Two hundred and sixteen FD patients will be randomly assigned to the compatible acupoints group, single acupoint group, or sham acupuncture group. This trial will include a 1-week baseline period, a 4-week treatment period, and a 4-week follow-up period. During the 4-week treatment period, patients will receive 20 sessions of acupuncture (weekly cycles of one session per day for 5 consecutive days followed by a 2-day break). The primary outcome will be a change in the Nepean Dyspepsia Life Quality Index from baseline to after the 4-week treatment period. Secondary outcome measures will include the dyspeptic symptom sum score, Overall Treatment Effect questionnaire, and 36-item Short Form survey. Adverse events also will be recorded. Ultraweak photon emission and metabolomics tests will be performed at baseline and at the end of treatment to explore the mechanisms of the differences between compatible acupoints and a single acupoint. The results of this trial will allow us to compare the difference in efficacy between compatible acupoints and a single acupoint. The findings from this trial will be published in peer-reviewed journals. Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-IPC-18000176, registered on 4 March 2019; Chinese Clinical Trial Registry, ChiCTR1900023983, registered on 23 June 2019.

    更新日期:2020-01-15
  • Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-14
    Pedro Parreira; Liliana B. Sousa; Inês A. Marques; Paulo Santos-Costa; Luciene M. Braga; Arménio Cruz; Anabela Salgueiro-Oliveira

    The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing should be carried out both pre- and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, and also increasing the need for manipulation of the venous catheter). A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes (arm B). The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day. The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of this medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate nurses’ adoption of good clinical practices in intravenous procedures, reducing catheter manipulations. ClinicalTrials.gov, NCT04046770. Registered 13 August 2019.

    更新日期:2020-01-15
  • KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-14
    L. L. Laslett; B. Antony; A. E. Wluka; C. Hill; L. March; H. I. Keen; P. Otahal; F. M. Cicuttini; G. Jones

    Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2 g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. This study will provide high-quality evidence to assess whether krill oil 2 g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice. Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111–1181-7087.

    更新日期:2020-01-15
  • Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study
    Trials (IF 1.975) Pub Date : 2020-01-14
    Frank Tegtmeier; Reinhard Schinzel; Ronny Beer; Diederik Bulters; Jean-Yves LeFrant; Joan Sahuquillo; Andreas Unterberg; Peter Andrews; Antonio Belli; Javier Ibanez; Alfonso Lagares; Michael Mokry; Harald Willschke; Charlotte Flühe; Erich Schmutzhard

    Traumatic brain injury is a leading cause of death and disability worldwide. The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial. The NOSTRA phase III trial (Ronopterin in traumatic brain injury) is a multi-centre, prospective, randomised, double-blinded, placebo-controlled, phase III trial in Europe. It aims at determining whether the administration of Ronopterin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at 6 months after injury. The trial is designed to recruit patients between 18 and 60 years of age with moderate or severe traumatic brain injury (Glasgow Coma Scale score ≥ 3) and requiring insertion of an intracranial pressure probe. Trial patients will receive a 48-h intravenous infusion of either Ronopterin or placebo starting at the earliest 6 h and at the latest 18 h after injury. The primary outcome will be the extended Glasgow Outcome Score (eGOS) at 6 months. Secondary outcomes will include the Quality of Life Index (QOLIBRI) at 6 months after the injury and the eGOS at 3 months after the injury. Additionally, effects on mortality, intracranial pressure and cerebral perfusion pressure are evaluated. The trial aims to provide evidence on the efficacy and safety of Ronopterin in patients with traumatic brain injury. EudraCT, 2013–003368-29. Registered on 9 March 2016. ClinicalTrials.gov, NCT02794168. Registered on 8 June 2016. Protocol version 14.0 from 05 November 2018.

    更新日期:2020-01-15
  • Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial)
    Trials (IF 1.975) Pub Date : 2020-01-14
    Min Chul Kim; Yeon Joo Lee; Jong Sun Park; Young-Jae Cho; Ho Il Yoon; Choon-Taek Lee; Jae Ho Lee; Eun Sun Kim

    High-flow nasal cannula (HFNC) oxygen therapy has been widely used in critically ill patients. Despite the effectiveness of HFNC as a treatment, optimal methods to withdraw HFNC after recovery from preexisting conditions have not been investigated to date. In this study, we will evaluate the safety and efficacy of simultaneous reduction of flow and fraction of inspired oxygen (FiO2) compared with sequential reduction of either flow first or FiO2 reduction first in patients with HFNC. This is a prospective, investigator-initiated, randomized controlled trial with three experimental intervention groups. A total of 100 adult patients receiving HFNC and satisfying weaning criteria will be enrolled and randomly assigned to one of the following groups: flow reduction (FR) first, FiO2 reduction (OR) first, or simultaneous reduction (SR). In the FR group, flow will be reduced first by 10 L/min/h. When it reaches 20 L/min, FiO2 will then be reduced by 0.1 /h until it reaches 0.3. In the OR group, the FiO2 will be gradually reduced first by 0.1 /h until it reaches 0.3, then flow will be reduced by 10 L/min until it reaches 20 L/min. Finally, in the SR group, both the flow and FiO2 will be gradually reduced simultaneously by 10 L/min and 0.1/h, respectively. Weaning will proceed only when patients satisfy the weaning criteria at every weaning point. When the HFNC weaning-off targets are reached (20 L/min and 0.3 for flow and FiO2, respectively), the patient will be transferred to conventional oxygen therapy (mainly low-flow nasal prongs). The primary outcome is the time to successful weaning from HFNC for 24 h. Secondary outcomes will include the success or failure rate in weaning off HFNC and changes in arterial blood gas analyses, intolerance rate, length of hospital stay, and in-hospital mortality. This study will be the first clinical trial to investigate the safety and efficacy of three different methods of weaning in adult patients receiving HFNC. Once this study is completed, we expect to be able to suggest the better strategy for withdrawal of HFNC based on the results. ClinicalTrials.gov, NCT03845244. Registered on 19 February 2019.

    更新日期:2020-01-15
  • Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-14
    Niccolò Butti; Emilia Biffi; Chiara Genova; Romina Romaniello; Davide Felice Redaelli; Gianluigi Reni; Renato Borgatti; Cosimo Urgesi

    Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). The study is an interventional randomised controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental group or the active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates in a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by eight 45-min sessions and are administered in the GRAIL VR laboratory (Motekforce Link, Netherlands), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) of the two trainings (T1) and at the end (T2). Moreover, a battery of neurocognitive tests spanning different domains is administered to all participants at T0, T2 and in a follow-up session after 2 months from the end of the two trainings (T3). This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new, intensive, social cognition training in a sample of Italian patients aged 7–25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills. ISRCTN, ID: ISRCTN 22332873. Retrospectively registered on 12 March 2018.

    更新日期:2020-01-15
  • Bayesian adaptive designs for multi-arm trials: an orthopaedic case study
    Trials (IF 1.975) Pub Date : 2020-01-14
    Elizabeth G. Ryan; Sarah E. Lamb; Esther Williamson; Simon Gates

    Bayesian adaptive designs can be more efficient than traditional methods for multi-arm randomised controlled trials. The aim of this work was to demonstrate how Bayesian adaptive designs can be constructed for multi-arm phase III clinical trials and assess potential benefits that these designs offer. We constructed several alternative Bayesian adaptive designs for the Collaborative Ankle Support Trial (CAST), which was a randomised controlled trial that compared four treatments for severe ankle sprain. These designs incorporated response adaptive randomisation (RAR), arm dropping, and early stopping for efficacy or futility. We studied the operating characteristics of the Bayesian designs via simulation. We then virtually re-executed the trial by implementing the Bayesian adaptive designs using patient data sampled from the CAST study to demonstrate the practical applicability of the designs. We constructed five Bayesian adaptive designs, each of which had high power and recruited fewer patients on average than the original designs target sample size. The virtual executions showed that most of the Bayesian designs would have led to trials that declared superiority of one of the interventions over the control. Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis. Similar estimates and conclusions were obtained from the Bayesian adaptive designs as from the original trial. Using CAST as an example, this case study shows how Bayesian adaptive designs can be constructed for phase III multi-arm trials using clinically relevant decision criteria. These designs demonstrated that they can potentially generate earlier results and allocate more patients to better performing arms. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. CAST study registration ISRCTN, ISRCTN37807450. Retrospectively registered on 25 April 2003.

    更新日期:2020-01-15
  • Bayesian group sequential designs for phase III emergency medicine trials: a case study using the PARAMEDIC2 trial
    Trials (IF 1.975) Pub Date : 2020-01-14
    Elizabeth G. Ryan; Nigel Stallard; Ranjit Lall; Chen Ji; Gavin D. Perkins; Simon Gates

    Phase III trials often require large sample sizes, leading to high costs and delays in clinical decision-making. Group sequential designs can improve trial efficiency by allowing for early stopping for efficacy and/or futility and thus may decrease the sample size, trial duration and associated costs. Bayesian approaches may offer additional benefits by incorporating previous information into the analyses and using decision criteria that are more practically relevant than those used in frequentist approaches. Frequentist group sequential designs have often been used for phase III studies, but the use of Bayesian group sequential designs is less common. The aim of this work was to explore how Bayesian group sequential designs could be constructed for phase III trials conducted in emergency medicine. The PARAMEDIC2 trial was a phase III randomised controlled trial that compared the use of adrenaline to placebo in out-of-hospital cardiac arrest patients on 30-day survival rates. It used a frequentist group sequential design to allow early stopping for efficacy or harm. We constructed several alternative Bayesian group sequential designs and studied their operating characteristics via simulation. We then virtually re-executed the trial by applying the Bayesian designs to the PARAMEDIC2 data to demonstrate what might have happened if these designs had been used in practice. We produced three alternative Bayesian group sequential designs, each of which had greater than 90% power to detect the target treatment effect. A Bayesian design which performed interim analyses every 500 patients recruited produced the lowest average sample size. Using the alternative designs, the PARAMEDIC2 trial could have declared adrenaline superior for 30-day survival with approximately 1500 fewer patients. Using the PARAMEDIC2 trial as a case study, we demonstrated how Bayesian group sequential designs can be constructed for phase III emergency medicine trials. The Bayesian framework enabled us to obtain efficient designs using decision criteria based on the probability of benefit or harm. It also enabled us to incorporate information from previous studies on the treatment effect via the prior distributions. We recommend the wider use of Bayesian approaches in phase III clinical trials. PARAMEDIC2 Trial registration ISRCTN, ISRCTN73485024. Registered 13 March 2014, http://www.isrctn.com/ISRCTN73485024

    更新日期:2020-01-15
  • A study protocol for a randomised trial of adjunct computerised memory specificity training (c-MeST) for major depression in youth: targeting cognitive mechanisms to enhance usual care outcomes in mental health settings
    Trials (IF 1.975) Pub Date : 2020-01-14
    D. J. Hallford; A. M. Carmichael; D. W. Austin; K. Takano; F. Raes; M. Fuller-Tyszkiewicz

    Youth depression is highly prevalent and is related to impairments in academic, social and behavioural functioning. Evidence-based treatments are available, but many young people do not respond or sufficiently recover with first-line options, and a significant proportion experience relapse. Consequently, there is clear scope to enhance intervention in this critical period of early-onset depression. Memory specificity training (MeST) is a low-intensity intervention for depression that targets reduced specificity when recalling memories of the past, a common cognitive vulnerability in depression. This randomised controlled trial will assess the efficacy of adding a computerised version of MeST (c-MeST) to usual care for youth depression. Young people aged 15–25 years with a major depressive episode (MDE) will be recruited and randomised to have immediate access to the seven session online c-MeST program in addition to usual care, or to usual care and wait-list for c-MeST. The primary outcomes will be diagnostic status of an MDE and self-reported depressive symptoms assessed at baseline, 1-, 3- and 6-month intervals. Autobiographical memory specificity and other variables thought to contribute to the maintenance of reduced memory specificity and depression will be assessed as mediators of change. Online provision of c-MeST provides a simple, low-intensity option for targeting a cognitive vulnerability that predicts the persistence of depressive symptoms. If found to be efficacious as an adjunct to usual care for depressed youth, it could be suitable for broader roll-out, as c-MeST is highly accessible and implementation requires only minimal resources due to the online and automated nature of intervention. Australian New Zealand Clinical Trials Registry, ACTRN12619000234112p. Registered on the 18 February 2019. All items from the WHO Trial Registration Data Set can be found within the protocol. 1.0

    更新日期:2020-01-15
  • Correction to: An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study
    Trials (IF 1.975) Pub Date : 2020-01-13
    O. Diaz-Cambronero; G. Mazzinari; C. L. Errando; M. J. Schultz; B. Flor Lorente; N. García-Gregorio; M. Vila Montañés; Daniel Robles-Hernández; L. E. Olmedilla Arnal; A. Martín-De-Pablos; A. Marqués Marí; M. P. Argente Navarro

    After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.

    更新日期:2020-01-13
  • A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: the Antibiotics for Children with Diarrhoea (ABCD) trial protocol
    Trials (IF 1.975) Pub Date : 2020-01-13

    Acute diarrhoea is a common cause of illness and death among children in low- to middle-income settings. World Health Organization guidelines for the clinical management of acute watery diarrhoea in children focus on oral rehydration, supplemental zinc and feeding advice. Routine use of antibiotics is not recommended except when diarrhoea is bloody or cholera is suspected. Young children who are undernourished or have a dehydrating diarrhoea are more susceptible to death at 90 days after onset of diarrhoea. Given the mortality risk associated with diarrhoea in children with malnutrition or dehydrating diarrhoea, expanding the use of antibiotics for this subset of children could be an important intervention to reduce diarrhoea-associated mortality and morbidity. We designed the Antibiotics for Childhood Diarrhoea (ABCD) trial to test this intervention. ABCD is a double-blind, randomised trial recruiting 11,500 children aged 2–23 months presenting with acute non-bloody diarrhoea who are dehydrated and/or undernourished (i.e. have a high risk for mortality). Enrolled children in Bangladesh, India, Kenya, Malawi, Mali, Pakistan and Tanzania are randomised (1:1) to oral azithromycin 10 mg/kg or placebo once daily for 3 days and followed-up for 180 days. Primary efficacy endpoints are all-cause mortality during the 180 days post-enrolment and change in linear growth 90 days post-enrolment. Expanding the treatment of acute watery diarrhoea in high-risk children to include an antibiotic may offer an opportunity to reduce deaths. These benefits may result from direct antimicrobial effects on pathogens or other incompletely understood mechanisms including improved nutrition, alterations in immune responsiveness or improved enteric function. The expansion of indications for antibiotic use raises concerns about the emergence of antimicrobial resistance both within treated children and the communities in which they live. ABCD will monitor antimicrobial resistance. The ABCD trial has important policy implications. If the trial shows significant benefits of azithromycin use, this may provide evidence to support reconsideration of antibiotic indications in the present World Health Organization diarrhoea management guidelines. Conversely, if there is no evidence of benefit, these results will support the current avoidance of antibiotics except in dysentery or cholera, thereby avoiding inappropriate use of antibiotics and reaffirming the current guidelines. Clinicaltrials.gov, NCT03130114. Registered on April 26 2017.

    更新日期:2020-01-13
  • Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Reserarch Networks (PERN) study
    Trials (IF 1.975) Pub Date : 2020-01-13
    Simon Craig; Franz E. Babl; Stuart R. Dalziel; Charmaine Gray; Colin Powell; Khalid Al Ansari; Mark D. Lyttle; Damian Roland; Javier Benito; Roberto Velasco; Julia Hoeffe; Diana Moldovan; Graham Thompson; Suzanne Schuh; Joseph J. Zorc; Maria Kwok; Prashant Mahajan; Michael D. Johnson; Robert Sapien; Kajal Khanna; Pedro Rino; Javier Prego; Adriana Yock; Ricardo M. Fernandes; Indumathy Santhanam; Baljit Cheema; Gene Ong; Shu-Ling Chong; Andis Graudins

    Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. A 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of asthma severity. We will then identify practice differences in tne clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in acute paediatric asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with acute severe asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients/families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

    更新日期:2020-01-13
  • Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I
    Trials (IF 1.975) Pub Date : 2020-01-13
    J. S. S. P. Ferreira; R. H. Cruvinel Junior; E. Q. Silva; J. L. Veríssimo; R. L. Monteiro; D. S. Pereira; E. Y. Suda; C. D. Sartor; I. C. N. Sacco

    This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot–ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance. As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness. ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

    更新日期:2020-01-13
  • Swiss chocolate and free beverages to increase the motivation for scientific work amongst residents: a prospective interventional study in a non-academic teaching hospital in Switzerland
    Trials (IF 1.975) Pub Date : 2020-01-13
    Annika Rühle; Florian Oehme; Björn-Christian Link; Jürg Metzger; Henning Fischer; Michael Stickel; Dimitri E. Delagrammaticas; Reto Babst; Frank J. P. Beeres

    The success of a clinical trial depends on its recruitment of eligible patients; therefore, the recruitment period requires special attention. We hypothesized that with a new approach focused on continuous information and gratification, resident motivation to participate in scientific work will increase and recruitment rates will improve. Our new recruitment approach was applied to the recruitment phase of two prospective randomized trials (registered at the German Clinical Trials Register). Randomization of these trials was performed first using blinded envelopes; later a soft drink machine was used as the delivery tool of randomization as a lighthearted motivation to join scientific work and to reward the resident with free soft drinks for each recruitment. Residents were informed about the trial via a lecture and by mail. To increase interest everyone received Swiss chocolate. With a multiple choice survey we investigated the success of our actions at 6 and 12 months. Recruitment rates of the trials were evaluated and associated with the motivational approaches. Our residents rated their awareness of the trials with median 9 (IQR 7;9) during the first and 8 (IQR 5;9) during the second survey and their interest in scientific work with median 7 (IQR 4;8) and 6 (IQR 5;8). The percentage of residents feeling highly motivated improved from 58% to 70%. The recruitment rates stayed stably high over time with 73% and 72% in trial 1 and 90% and 85% in trial 2; 24% of residents stated their motivation could be increased by gratifications. After implementation of our new recruitment approach we found positively motivated residents and high recruitment rates in the corresponding trials. We propose this procedure may help to ensure the successful initiation of clinical trials. Larger studies testing this approach are warranted.

    更新日期:2020-01-13
  • Efficacy and safety of Guhong injection for treating coronary microvascular disease: study protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-13
    Zhuang Jieqin; Liu Shuling; Cai Hairong; Dai Xingzhen; Chen Yanhong; Jin Zilin; Chen Bojun

    Coronary microvascular disease (CMVD) can be described as one of the cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculatory lesions, often presenting as angina pectoris attacks. Coronary artery microtubular dysfunction is one of the pathogenic features of coronary heart disease, but its occurrence and development and the current CMVD-intervention therapy needs further research. Chinese traditional medicine (TCM) has advantages for the treatment of cardiovascular diseases. Hence, this article describes an ongoing randomized controlled clinical trial based on the theory of TCM for the purpose of evaluating the efficacy and safety of Guhong injection versus placebo in patients with CMVD. This is a multicenter, randomized, parallel-arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, and with an 8-week follow-up. The primary outcome is therapeutic efficacy. Secondary outcomes include the quantitative score of TCM syndromes (a series of TCM symptoms and signs of coronary heart disease), the average frequency of anginal attacks, electrocardiogram (ECG) changes, inflammatory response, endothelial function indicators and myocardial metabolites. This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results should provide high-quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD. Chinese Clinical Trials Registry, ID: ChiCTR1900022902. Registered on 27 April 2019.

    更新日期:2020-01-13
  • Evaluation of the safety and tolerability of a nutritional Formulation in patients with ANgelman Syndrome (FANS): study protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-09
    Donna L. Herber; Edwin J. Weeber; Dominic P. D’Agostino; Jessica Duis

    Ketogenic and low-glycemic-index diets are effective in treating drug-resistant seizures in children with Angelman syndrome. Cognition, mobility, sleep, and gastrointestinal health are intrinsically linked to seizure activity and overall quality of life. Ketogenic and low-glycemic diets restrict carbohydrate consumption and stabilize blood glucose levels. The ketogenic diet induces ketosis, a metabolic state where ketone bodies are preferentially used for fuel. The use of exogenous ketones in promoting ketosis in Angelman syndrome has not been previously studied. The study formulation evaluated herein contains the exogenous ketone beta-hydroxybutyrate to rapidly shift the body towards ketosis, resulting in enhanced metabolic efficiency. This is a 16-week, randomized, double-blind, placebo-controlled, crossover study to assess the safety and tolerability of a nutritional formula containing exogenous ketones. It also examines the potential for exogenous ketones to improve the patient’s nutritional status which can impact the physiologic, symptomatic, and health outcome liabilities of living with Angelman syndrome. This manuscript outlines the rationale for a study designed to be the first to provide data on nutritional approaches for patients with Angelman syndrome using exogenous ketones. ClinicalTrials.gov, ID: NCT03644693. Registered on 23 August 2018. Last updated on 23 August 2018.

    更新日期:2020-01-11
  • Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol
    Trials (IF 1.975) Pub Date : 2020-01-10
    Goeran Fiedler; Anita Singh; Xueyi Zhang

    In people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface between residual limb and prosthetic socket, where the objectives of sufficient weight distribution and suspension are conflicting with the necessity to facilitate heat exchange and limit contact pressure and friction. Recently, prosthesis liners that contain phase-change material have become commercially available, holding the promise that the micro climate at the interface between the residual limb skin and the prosthetic socket can be regulated to reduce the users’ tendency to sweat. Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners. However, the clinical relevance of those findings remains unclear. The purpose of this study is to investigate whether longer (6+ months) periods of use of phase-change material based temperature-control liners have clinically meaningful effects. The protocol is a double-blind longitudinal cross-over research design. A sample of trans-tibial prosthesis users are wearing their regular gel or silicone liners for six months and phase-change material liners for another six months in a randomized sequence. Their prostheses is equipped with activity monitors to detect days when they could not wear their prosthesis. In six-week intervals, individuals’ activity, physical performance, and overall prosthesis assessment is recorded using standardized methods. Expected results will inform prescription and reimbursement practice of phase-change material-based prosthesis liners and will help improve and economize prosthetic fitting for people with limb loss. The design and duration of the protocol, including randomization, blinding, and within-subject comparison, will generate scientific evidence of a comparably high level. Inclusion of a comparably large sample and different climates, e.g. across all four seasons, will make findings applicable to a large number of prosthesis users. Clinicaltrials.gov, NCT03428815. Registered on 12 February 2018.

    更新日期:2020-01-11
  • A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas)
    Trials (IF 1.975) Pub Date : 2020-01-10
    Daniela Kniepeiss; Philipp Houben; Philipp Stiegler; Andrea Berghold; Regina Riedl; Judith Kahn; Peter Schemmer

    Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider’s histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney and pancreas preservation. Organ preservation with both solutions is comparable; recently, however, Custodiol® solution has been modified to Custodiol-N according to the needs of today. Thus, our study was defined to study its effect in clinical transplantation. Patients undergoing kidney transplantation (n = 412) (including approximately 30 combined kidney–pancreas) or liver transplantation (n = 202) receive grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation. Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution. Further clinical safety data on Custodiol-N for cardioplegia are available. Thus, this study was designed to compare Custodiol® with Custodiol-N for the first time in a prospective, randomized, single-blinded, multicentre, phase III clinical transplantation trial. Eudra-CT, 2017–002198-20. Registered on 28 November 2018.

    更新日期:2020-01-11
  • Evaluation of the Teaching Recovery Techniques community-based intervention for unaccompanied refugee youth experiencing post-traumatic stress symptoms (Swedish UnaccomPanied yOuth Refugee Trial; SUPpORT): study protocol for a randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-10
    Anna Sarkadi; Georgina Warner; Raziye Salari; Karin Fängström; Natalie Durbeej; Elin Lampa; Zaruhi Baghdasaryan; Fatumo Osman; Sandra Gupta Löfving; Anna Perez Aronsson; Inna Feldman; Filipa Sampaio; Richard Ssegonja; Rachel Calam; Anna Bjärtå; Anna Leiler; Elisabet Rondung; Elisabet Wasteson; Brit Oppedal; Brooks Keeshin

    In 2015, 162,877 persons sought asylum in Sweden, 35,369 of whom were unaccompanied refugee minors (URMs). Refugee children, especially URMs, have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue years after resettlement. The Swedish UnaccomPanied yOuth Refugee Trial (SUPpORT) aims to evaluate a community-based intervention, called Teaching Recovery Techniques (TRT), for refugee youth experiencing PTSD symptoms. A randomised controlled trial will be conducted in which participants will be randomly allocated to one of two possible arms: the intervention arm (n = 109) will be offered the TRT programme, and the waitlist-control arm (n = 109) will receive services as usual, followed by the TRT programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; about 8 weeks after randomisation) and follow-up (T3; about 20 weeks after randomisation). This study will provide knowledge about the effect and efficiency of a group intervention for URMs reporting symptoms of PTSD in Sweden. ISRCTN, ISRCTN47820795. Prospectively registered on 20 December 2018.

    更新日期:2020-01-11
  • Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-10
    Stephanie S. Leone; Suzanne Lokman; Brigitte Boon; Agnes van der Poel; Filip Smit; Moniek Zijlstra-Vlasveld; Odile Smeets

    Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this. The online ‘Complaint Directed Mini-Interventions’ (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline. This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care. Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.

    更新日期:2020-01-11
  • The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments
    Trials (IF 1.975) Pub Date : 2020-01-10
    Bethany M. Kwan; L. Miriam Dickinson; Russell E. Glasgow; Martha Sajatovic; Mark Gritz; Jodi Summers Holtrop; Don E. Nease; Natalie Ritchie; Andrea Nederveld; Dennis Gurfinkel; Jeanette A. Waxmonsky

    Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

    更新日期:2020-01-11
  • Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity
    Trials (IF 1.975) Pub Date : 2020-01-10
    Daniela Mercado; Jessica Werthmann; Iain C. Campbell; Ulrike Schmidt

    Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown. We describe the theoretical basis and the rationale for a study protocol of a feasibility randomised controlled trial (RCT) comparing two attention trainings (ABMT vs Mindfulness Training [MT]) in people with overweight or obesity. The aim of this study is to inform the development of a large-scale RCT in relation to acceptability and attendance rates and to identify preliminary evidence for the interventions’ clinical efficacy and potential underlying mechanisms. Forty-five adults who are either overweight or obese (minimum body mass index of 25 kg/m2) will be randomly allocated to receive eight sessions over eight weeks of either computerised ABMT or MT or be on a waiting list. Clinical and cognitive outcomes will be assessed at baseline, post-treatment (8 weeks) and follow-up (12 weeks post-randomisation). These include mood, body composition and attention biases. Credibility and acceptability of the trainings will be assessed using questionnaires, and recruitment and retention rates will be recorded. Findings will inform the feasibility of developing a large-scale RCT that takes into consideration effect sizes for primary outcome measures and the acceptability of the design. The study will also provide preliminary evidence on the clinical efficacy of two different attention trainings for people with obesity and associated underlying mechanisms. ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018. 

    更新日期:2020-01-11
  • Clinician–researchers and custodians of scarce resources: a qualitative study of health professionals’ views on barriers to the involvement of teenagers and young adults in cancer trials
    Trials (IF 1.975) Pub Date : 2020-01-10
    Ruth I. Hart; Nina Hallowell; Jeni Harden; Angela B. Jesudason; Julia Lawton

    Equipoise and role conflict have been previously identified as important factors in professionals’ engagement with trials, inducing behaviours which can impact on recruitment. We explored these phenomena as potential explanations for the low levels of involvement of teenagers and young adults (TYA) with cancer in clinical trials in oncology. We report findings from interviews with 30 purposively sampled direct-care professionals involved in delivering cancer care and/or facilitating clinical trials in Scotland. We undertook qualitative descriptive analysis, focussed on identifying key issues and themes. Interviewees largely identified as clinician–researchers and portrayed oncology as a specialty in which research was integral to care. They saw their primary responsibility as ensuring patients received the best treatment, but asserted that, in general, trials provided a vehicle for optimal care. Role conflict in its traditional form was rarely evident; however, other tensions were manifest. Professionals found the significant time costs of delivering trials difficult to reconcile with the increasing pressures on clinical services. They felt a responsibility to make prudent choices about the trials with which to engage. Guided by utilitarian principles, these choices were oriented towards benefiting the largest number of patients. This favoured trials in high volume diseases; as TYA tend to have rarer forms of cancer, professionals’ support for—and TYA’s access to—relevant trials was, by default, more limited. Neither lack of individual equipoise nor experiences of traditional forms of role conflict accounted for the low levels of involvement of TYA with cancer in clinical trials. However, prominent tensions around the management of scarce resources provided an alternative explanation for TYA’s limited access to cancer trials. The prevailing approach to decision-making about whether and which trials to support was recognised as contributing to inequalities in access and care. Professionals’ choices, however, were made in the context of scarcity, and structured by incentives and sanctions understood by them as signalling governmental priorities. A franker discussion of the extent and distribution of the costs and benefits of trials work is needed, for change to be achieved.

    更新日期:2020-01-11
  • A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials
    Trials (IF 1.975) Pub Date : 2020-01-10
    Kris McGill; Catherine M. Sackley; Jon Godwin; Jodie McGarry; Marian C. Brady

    Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke rehabilitation RCTs has not been explored. To explore recruitment efficiency and the trial features associated with efficient recruitment to stroke rehabilitation RCTs. A systematic review of stroke rehabilitation RCTs published between 2005 and 2015 identified in a search of the Cochrane Stroke Group (CSG) Trials Register from 35 electronic databases (e.g. Medline, CINAHL; EMBASE), clinical trial registers, and hand-searching. Inclusion criteria are stroke rehabilitation intervention, delivered by a member of the rehabilitation team, and clinically relevant environment. We extracted data on recruitment efficiency and trial features. We screened 12,939 titles, 1270 abstracts and 788 full texts, before extracting data from 512 included RCTs (n = 28,804 stroke survivor participants). This is the largest systematic review of recruitment to date. A third of stroke survivors screened consented to participate (median 34% (IQR 14–61), on average sites recruited 1.5 participants per site per month (IQR 0.71–3.22), and one in twenty (6% (IQR 0–13) dropped out during the RCT. Almost half (48%) of those screened in the community were recruited compared to hospital settings (27%). Similarly, almost half (47%) those screened at least 6 months after stroke participated, compared to 23% of stroke survivors screened within a month of stroke. When one recruiter screened multiple sites, a median of one stroke survivor was recruited every 2 months compared to more than two per month when there was a dedicated recruiter per site. RCT recruitment was significantly faster per site, with fewer dropouts, for trials conducted in Asia (almost three stroke survivors monthly; 2% dropout) compared to European trials (approximately one stroke survivor monthly; 7% dropout). One third of stroke survivors screened were randomised to rehabilitation RCTs at a rate of between one and two per month, per site. One in twenty did not complete the trial. Our findings will inform recruitment plans of future stroke rehabilitation RCTs. Limited reporting of recruitment details restricted the subgroup analysis performed. Prospective Register of Systematic Reviews, registration number CRD42016033067.

    更新日期:2020-01-11
  • Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-10
    Zeng-Qiao Zhang; Kun-Peng Li; Jing He; Li-Ming Jiang; Wu Wang; Xiao-Shen Hu; Wei Feng

    The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation have shown that fascial-point needling can effectively alleviate hand spasm immediately after stroke, but further evidence from large-sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial-point acupuncture on hand spasm after stroke. This multicenter randomized controlled trial will compare the efficacy of fascial-point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial-point acupuncture, the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indices are the remission of hand spasm and the duration of spasm remission. The second evaluation indices are the hand function of the affected limbs and the activities of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. Our aim is to evaluate the efficacy of fascial-point acupuncture in relieving hand spasm after stroke. The results should provide more evidence for the clinical application of this therapy in the future. Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR1900022379. Registered on 9 April 2019

    更新日期:2020-01-11
  • Individualised stepwise adaptive treatment for 3–6-year-old preschool children impaired by attention-deficit/hyperactivity disorder (ESCApreschool): study protocol of an adaptive intervention study including two randomised controlled trials within the consortium ESCAlife
    Trials (IF 1.975) Pub Date : 2020-01-09
    Katja Becker; Tobias Banaschewski; Daniel Brandeis; Christina Dose; Christopher Hautmann; Martin Holtmann; Thomas Jans; Lea Jendreizik; Carolin Jenkner; Katja John; Johanna Ketter; Sabina Millenet; Ursula Pauli-Pott; Tobias Renner; Marcel Romanos; Anne-Katrin Treier; Elena von Wirth; Anne-Kathrin Wermter; Manfred Döpfner

    Attention-deficit/hyperactivity disorder (ADHD) is a psychosocially impairing and cost-intensive mental disorder, with first symptoms occurring in early childhood. It can usually be diagnosed reliably at preschool age. Early detection of children with ADHD symptoms and an early, age-appropriate treatment are needed in order to reduce symptoms, prevent secondary problems and enable a better school start. Despite existing ADHD treatment research and guideline recommendations for the treatment of ADHD in preschool children, there is still a need to optimise individualised treatment strategies in order to improve outcomes. Therefore, the ESCApreschool study (Evidence-Based, Stepped Care of ADHD in Preschool Children aged 3 years and 0 months to 6 years and 11 months of age (3;0 to 6;11 years) addresses the treatment of 3–6-year-old preschool children with elevated ADHD symptoms within a large multicentre trial. The study aims to investigate the efficacy of an individualised stepwise-intensifying treatment programme. The target sample size of ESCApreschool is 200 children (boys and girls) aged 3;0 to 6;11 years with an ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or a diagnosis of oppositional defiant disorder (ODD) plus additional substantial ADHD symptoms. The first step of the adaptive, stepped care design used in ESCApreschool consists of a telephone-assisted self-help (TASH) intervention for parents. Participants are randomised to either the TASH group or a waiting control group. The treatment in step 2 depends on the outcome of step 1: TASH responders without significant residual ADHD/ODD symptoms receive booster sessions of TASH. Partial or non-responders of step 1 are randomised again to either parent management and preschool teacher training or treatment as usual. The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care. The trial was registered at the German Clinical Trials Register (DRKS) as a Current Controlled Trial under DRKS00008971 on 1 October 2015. This manuscript is based on protocol version 3 (14 October 2016).

    更新日期:2020-01-09
  • A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-09
    Matthias Knefel; Viktoria Kantor; Andrew A. Nicholson; Jennifer Schiess-Jokanovic; Dina Weindl; Ingo Schäfer; Brigitte Lueger-Schuster

    Asylum seekers and refugees are at great risk for developing mental disorders. Afghan refugees are a particularly vulnerable group with a low average education and mental health literacy level. Traumatic experiences and hardship before and during migration are predictive of mental health problems. However, post-migration living difficulties (PMLDs) also account for a large proportion of mental distress in such populations, which, critically, are not sufficiently considered in treatment protocols and research investigations. Indeed, the evidence base for the treatment of refugees and asylum seekers is sparse and limited mainly to trauma-specific treatments, where refugees may likely suffer from other mental health problems such as depression or anxiety. This trial is the first evaluation of a short-term, transdiagnostic treatment protocol for treatment-seeking Afghan refugees which addresses mental health problems and PMLDs while using an adapted version of the Problem Management Plus (PM+) protocol. Here, we will investigate the efficacy of an intervention manual with a prospective, single-center, randomized, assessor-blind, two-group trial among refugees who are on a waiting list for professional mental health treatment. Furthermore, we will investigate participants’ subjective experiences with the intervention manual via in-depth interviews. One hundred twenty people will be assessed and randomly allocated to either the intervention arm or a treatment-as-usual arm. Clinical psychologists will conduct the treatment, and the sessions will take place with a Dari interpreter. The protocol consists of six 90-min sessions. The primary endpoint is the general symptom distress measure, assessed with the General Health Questionnaire 28 (GHQ-28). Secondary endpoints are the Post-Migration Living Difficulties Checklist (PMLDC), the International Trauma Questionnaire (ITQ), the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), the Psychological Outcome Profile (PSYCHLOPS), service and health care use (assessed with several items), and the Immigrant Integration Index (IPL-12). This trial may provide substantial evidence for a brief transdiagnostic psychological intervention. Here, we intend to contribute to the treatment of mental health problems among Afghan refugees. The assessment of subjective experience with this treatment manual, as well as the evaluation of its clinical applicability, may optimize treatment acceptance and outcomes across a wide range of mental health problems among refugees. German Clinical Trials Register (DRKS) registration number: DRKS00016538. Universal Trial Number: U1111-1226-3285. Registered on January 7, 2019. https://www.drks.de/drks_web/setLocale_EN.do

    更新日期:2020-01-09
  • The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in patients with coloreactal cancer: study protocol for a single-blinded, randomized sham-controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-09
    Kaiyin Chan; Louisa Lui; Kaling Yu; Kwongwai Lau; Manchi Lai; Waiwai Lau; Bacon Ng; Linda L. D. Zhong; Zhao-Xiang Bian

    Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine. This study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in patients with colorectal cancer in Hong Kong. This is a single-blinded, randomized, sham-controlled efficacy trial. Eighty-four eligible patients, who are Hong Kong Chinese, aged ≥ 18 years, diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 1:1 to the electro-acupuncture group or the sham-controlled group. During a 12-week treatment period, patients in the electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, while patients in the control group will receive sham acupuncture, and the patients in both groups will be followed up for 12 weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ). The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy. Clinicaltrials.gov, NCT03582423. Registered on 11 July 2018.

    更新日期:2020-01-09
  • Monitoring in practice – How are UK academic clinical trials monitored? A survey
    Trials (IF 1.975) Pub Date : 2020-01-09
    Sharon B. Love; Victoria Yorke-Edwards; Sarah Lensen; Matthew R. Sydes

    Despite the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) encouraging the use of risk-based monitoring for trials in 2013, there remains a lack of evidence-based guidelines on how to monitor. We surveyed the academic United Kingdom Clinical Research Collaboration (UKCRC) registered clinical trials units (CTUs) to find out their policy on monitoring of phase III randomised clinical trials of an investigational medicinal product (CTIMPs). An online survey of monitoring policy with sections on the CTU, central monitoring and on-site monitoring was sent to all 50 UKCRC registered CTUs in November 2018. Descriptive data analysis and tabulations are reported using the total number answering each question. A total of 43/50 (86%) of CTUs responded with 38 conducting phase III randomised CTIMP trials. Of these 38 CTUs, 34 finished the survey. Most CTUs (36/37, 97%) use a central monitoring process to guide, target or supplement site visits. More than half (19/36, 53%) of CTUs do not use an automated monitoring report when centrally monitoring trials and all units use trial team knowledge to make a final decision on whether an on-site visit is required. A total of 31/34 (91%) CTUs used triggers to decide whether or not to conduct an on-site monitoring visit. On-site, a mixture of source data verification and checking of processes was carried out. The CTUs overwhelmingly (27/34, 79%) selected optimising central monitoring as their most pressing concern. The survey showed a wide variation in phase III randomised CTIMP trial monitoring practices by academic clinical trials units within a single research-active country. We urgently need to develop evidence-based regulator-agreed guidance for CTUs on best practice for both central and on-site monitoring and to develop tools for all CTUs to use.

    更新日期:2020-01-09
  • Personalising psychotherapies for depression using a novel mixed methods approach: an example from Morita therapy
    Trials (IF 1.975) Pub Date : 2020-01-08
    Holly Victoria Rose Sugg; Julia Frost; David A. Richards

    Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years. Novel alternative methods to generate hypotheses for prospective testing are therefore required, and we showcase mixed methods as one such approach. By exploring patients’ perspectives in depth, and integrating qualitative and quantitative data at the level of the individual, we may identify new potential psychosocial predictors of psychotherapy outcomes, potentially informing the personalisation of depression treatment in a shorter timeframe. Using Morita therapy (a Japanese psychotherapy) as an exemplar, we thus explored how Morita therapy recipients’ views on treatment acceptability explain their adherence and response to treatment. The Morita trial incorporated a pilot randomised controlled trial of Morita therapy versus treatment as usual for depression, and post-treatment qualitative interviews. We recruited trial participants from general practice record searches in Devon, UK, and purposively sampled data from 16 participants for our mixed methods analysis. We developed typologies of participants’ views from our qualitative themes, and integrated these with quantitative data on number of sessions attended and whether participants responded to treatment in a joint typologies and statistics display. We enriched our analysis using participant vignettes to demonstrate each typology. We demonstrated that (1) participants who could identify with the principles of Morita therapy typically responded to treatment, regardless of how many sessions they attended, whilst those whose orientation towards treatment was incompatible with Morita therapy did not respond to treatment, again regardless of treatment adherence and (2) participants whose personal circumstances impeded their opportunity to engage in Morita therapy attended the fewest sessions, though still benefitted from treatment if the principles resonated with them. We identified new potential relationships between “orientation” and outcomes, and “opportunity” and adherence, which could not have been identified using existing non-integrative methods. This mixed methods approach warrants replication in future trials and with other psychotherapies to generate hypotheses, based on typologies (or profiles) of patients for whom a treatment is more or less likely to be suitable, to be tested in prospective trials. Current Controlled Trials, ISRCTN17544090. Registered on 23 July 2015.

    更新日期:2020-01-08
  • Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Marie-Hélène Masse; Julie Ménard; Sheila Sprague; Marie-Claude Battista; Deborah J. Cook; Gordon H. Guyatt; Daren K. Heyland; Salmaan Kanji; Ruxandra Pinto; Andrew G. Day; Dian Cohen; Djillali Annane; Shay McGuinness; Rachael Parke; Anitra Carr; Yaseen Arabi; Bharath Kumar Tirupakuzhi Vijayaraghavan; Frédérick D’Aragon; Élaine Carbonneau; David Maslove; Miranda Hunt; Bram Rochwerg; Tina Millen; Michaël Chassé; Martine Lebrasseur; Patrick Archambault; Estel Deblois; Christine Drouin; François Lellouche; Patricia Lizotte; Irene Watpool; Rebecca Porteous; France Clarke; Nicole Marinoff; Émilie Belley-Côté; Brigitte Bolduc; Scott Walker; John Iazzetta; Neill K. J. Adhikari; François Lamontagne

    Sepsis is a health problem of global importance; treatments focus on controlling infection and supporting failing organs. Recent clinical research suggests that intravenous vitamin C may decrease mortality in sepsis. We have designed a randomized controlled trial (RCT) to ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days in patients with sepsis. LOVIT (Lessening Organ dysfunction with VITamin C) is a multicenter, parallel-group, blinded (participants, clinicians, study personnel, Steering Committee members, data analysts), superiority RCT (minimum n = 800). Eligible patients have sepsis as the diagnosis for admission to the intensive care unit (ICU) and are receiving vasopressors. Those admitted to the ICU for more than 24 h are excluded. Eligible patients are randomized to high-dose intravenous vitamin C (50 mg/kg every 6 h for 96 h) or placebo. The primary outcome is a composite of death or persistent organ dysfunction (need for vasopressors, invasive mechanical ventilation, or new and persisting renal replacement therapy) at day 28. Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia). Six subgroup analyses are planned. This RCT will provide evidence of the effect of high-dose intravenous vitamin C on patient-important outcomes in patients with sepsis. clinicaltrials.gov, NCT03680274, first posted 21 September 2018.

    更新日期:2020-01-08
  • The effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery: a prospective, randomized, placebo-controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Xiangdi Yu; Fangxiang Zhang; Bingning Chen

    In current study we assessed the effect of transcutaneous electrical acupoint stimulation (TEAS) on the quality of early recovery in patients undergoing gynecological laparoscopic surgery. Sixty patients undergoing gynecological laparoscopic surgery were randomly assigned to TEAS (TEAS group) or control group (Con group). TEAS consisted of 30 min of stimulation (12–15 mA, 2/100 Hz) at the acupoints of Baihui (GV20), Yingtang (EX-HN-3), Zusanli (ST36) and Neiguan (PC6) before anesthesia. The patients in the Con group had the electrodes applied, but received no stimulation. Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1 (T0), postoperative day 1 (T1) and postoperative day 2 (T2); 100-mm visual analogue scale (VAS) scores at rest, mini-mental state examination (MMSE) scores, the incidence of nausea and vomiting, postoperative pain medications, and antiemetics were also recorded. Results: QoR-40 and MMSE scores of T0 showed no difference between two groups (QoR-40: 197.50 ± 2.57 vs. 195.83 ± 5.17), (MMSE: 26.83 ± 2.74 vs. 27.53 ± 2.88). Compared with the Con group, QoR-40 and MMSE scores of T1 and T2 were higher in the TEAS group (P < 0.05) (QoR-40: T1, 166.07 ± 8.44 vs. 175.33 ± 9.66; T2, 187.73 ± 5.47 vs. 191.40 ± 5.74), (MMSE: T1, 24.60 ± 2.35 vs. 26.10 ± 2.78; T2, 26.53 ± 2.94 vs. 27.83 ± 2.73). VAS scores of T1 and T2 were lower (P < 0.05) in the TEAS group (T1, 4.73 ± 1.53 vs. 3.70 ± 1.41; T2, 2.30 ± 0.95 vs. 1.83 ± 0.88); the incidence of postoperative nausea and vomiting (PONV), remedial antiemetics and remedial analgesia was lower in the TEAS group (P < 0.05) (PONV: 56.7% vs. 23.3%; incidence of remedial antiemetics: 53.3% vs. 23.3%; incidence of remedial analgesia: 80% vs. 43.3%). The use of TEAS significantly promoted the quality of early recovery, improved MMSE scores and reduced the incidence of pain, nausea and vomiting in patients undergoing gynecological laparoscopic surgery. ClinicalTrials.gov, NCT02619578. Registered on 2 December 2015. Trial registry name: https://clinicaltrials.gov

    更新日期:2020-01-08
  • Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a randomized controlled trial protocol
    Trials (IF 1.975) Pub Date : 2020-01-08
    Marlou J. G. Kooiker; Yoni van der Linden; Jenneke van Dijk; Ymie J. van der Zee; Renate M. C. Swarte; Liesbeth S. Smit; Sanny van der Steen-Kant; Sjoukje E. Loudon; Irwin K. M. Reiss; Kees Kuyper; Johan J. M. Pel; Johannes van der Steen

    An increasing number of children are suffering from brain damage-related visual processing dysfunctions (VPD). There is currently a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually adaptive, and is paired with quantitative outcome assessments. Our aim is to investigate the effectiveness of this first visual intervention program for young children with (a risk of) VPD. This is a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care, which involves an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consists of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to the specific needs of the child). Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA) or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Through this randomized controlled trial we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to a child’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life. Netherlands Trial Register: NTR6952. Registered 19 January 2018.

    更新日期:2020-01-08
  • Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Birgit Wagner; Laura Hofmann; Ulrike Maaß

    The death of a significant person through suicide is a very difficult experience and can have long-term impact on an individual’s psychosocial and physical functioning. However, there are only few studies that have examined the effects of interventions in suicide survivors. In the present study, we examine an online-group intervention for people bereaved by suicide using a group-webinar. The intervention was developed based on focus groups with the target group. The cognitive-behavioral 12-module webinar-based group intervention focuses on suicide bereavement-related themes such as feelings of guilt, stigmatization, meaning reconstruction and the relationship to the deceased. Further, the webinar includes testimonial videos and psychoeducation. The suicide survivors are randomized to the intervention or the waiting list in a group-cluster randomized controlled trial. Primary outcomes are suicidality (Beck Scale for Suicide Ideation) and depression (Beck Depression Inventory-II) and secondary outcomes are symptoms of prolonged grief disorder (Inventory of Complicated Grief-German Version ), posttraumatic stress disorder ( Revised Impact of Event Scale ), stigmatization (Stigma of Suicide and Suicide Survivor ) and posttraumatic cognitions (Posttraumatic Cognitions Inventory). Previous studies of Internet-based interventions for the bereaved were based on writing interventions showing large treatment effects. Little is known about the use of webinars as group interventions. Advantages and challenges of this novel approach of psychological interventions will be discussed. German Clinical Trials Register, DRKS00014426. Registered on 12 April 2018. 3, 21.10.2019.

    更新日期:2020-01-08
  • Evaluating the effects of an exercise program (Staying UpRight) for older adults in long-term care on rates of falls: study protocol for a randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Lynne Taylor; John Parsons; Denise Taylor; Elizabeth Binns; Sue Lord; Richard Edlin; Lynn Rochester; Silvia Del Din; Jochen Klenk; Christopher Buckley; Alana Cavadino; Simon A. Moyes; Ngaire Kerse

    Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively. This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018. This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population. Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148.

    更新日期:2020-01-08
  • The PROMOTE study (High-protein and resistance-training combination in overweight and obesity) for short-term weight loss and long-term weight maintenance for Chinese people: a protocol for a pilot randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Shaoyong Xu; Juan Zhang; Yuxiang Dong; Ruikun Chen; Wenlei Xu; Zhijun Tan; Ling Gao; Lei Shang

    It is very important for clinicians and dieticians to explore reasonable weight management strategies for obese people that address both short-term weight loss and subsequent weight maintenance. We hypothesized that resistance training combined with a high-protein diet would result in similar short-term weight loss but better long-term weight maintenance than either a conventional low-fat diet control or a high-protein diet alone. This is an 8-week randomized parallel controlled trial followed by a 24-week observational follow-up study. A 48-week supplementary follow-up study will be carried out if necessary. The study will be conducted between June 2019 and October 2020. The 90 overweight or obese participants will be randomly assigned to the conventional low-fat diet group, the high-protein diet group and the high-protein diet and resistance training combination group. Primary outcomes are body weight change at week 8 and week 24 compared with the baseline level. High-quality research on the effect of a high-protein diet combined resistance training on weight loss and weight maintenance is limited in the Chinese population. Our study will provide a basis for obesity management in China and will promote the development of exercise- and diet-related studies. Chinese Clinical Trial Registry, ChiCTR1900023841. Registered on 14 June 2019.

    更新日期:2020-01-08
  • Initiate Danhong Injection before or after percutaneous coronary intervention for microvascular obstruction in ST-elevation myocardial infarction (DIRECTION): study protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Xiaoyu Zhang; Guihua Tian; Zhaofeng Shi; Yang Sun; Jiayuan Hu; Yin Jiang; Rui Zheng; Shiqi Chen; Chengyu Li; Xinyu Yang; Tianmai He; Songjie Han; Chi Zhang; Lijing Zhang; Yan Liu; Hongcai Shang

    No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong Injection. However, evidence of a rigorously designed verification study is still lacking, and the intervention timing of Danhong Injection is uncertain. The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind study. A total of 336 patients with STEMI receiving percutaneous coronary intervention (PCI) will be randomly assigned to conventional treatment, the preoperative Danhong Injection, or the postoperative Danhong Injection. The primary outcome is rate of ST-segment resolution (STR) ≥ 70% at 90 min after PCI. The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin I (cTnI) and for creatine kinase MB. The major adverse cardiovascular events and hospital readmission events will be recorded. Health quality will be assessed with the 12-item Short Form Health Survey. The safety outcomes include bleeding events, adverse events, and abnormal changes in routine blood tests. Psychological status and dietary patterns will be evaluated using Hamilton Depression Rating Scale and Food Frequency Questionnaire as the relevant indicators. This trial will evaluate the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention to prevent MVO in patients with STEMI. Chinese Clinical Trial Registry, ChiCTR1900021440. Registered on February 21, 2019.

    更新日期:2020-01-08
  • Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study
    Trials (IF 1.975) Pub Date : 2020-01-08
    Zhi-peng Xiao; ke Jin; Jie-qing Wan; Yong Lin; Yao-hua Pan; Yi-chao Jin; Xiao-hua Zhang

    Cerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke. This is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniques for the evaluation of CVR to improve treatment of patients with ischemic stroke. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. The patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months. Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke. Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635; Registered on 16 October 2016. All items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635.

    更新日期:2020-01-08
  • Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students
    Trials (IF 1.975) Pub Date : 2020-01-08
    Tracy M. Scull; Christina V. Malik; Abigail Morrison; Elyse M. Keefe

    School-based comprehensive sexual health education can improve adolescent health outcomes, and web-based programs are a promising approach to overcoming challenges associated with teacher-led formats by ensuring that students receive content that is consistent, unbiased, and medically accurate. However, many adolescents do not receive high-quality sexual health education and turn to the media for information about sex and relationships. Consumption of sexual media messages is related to early and risky sexual behaviors. Media literacy education (MLE) is a proven approach to adolescent sexual health promotion, yet there are no rigorously evaluated web-based MLE programs to promote sexual and relationship health among high school students. This study will test the efficacy, in a randomized controlled trial, of Media Aware, a web-based comprehensive sexual health promotion program for high school students that uses an MLE approach. Participants will be students in 9th and 10th grade health classes in participating schools. Randomization will take place at the school level, and data collection will take place at three time points (i.e., pretest, posttest, and 3 months follow-up). Students in the intervention classrooms will receive Media Aware between pretest and posttest, and students in the delayed-intervention classrooms will receive Media Aware after study completion (i.e., after 3 months follow-up data collection). Students in the delayed-intervention classes will receive their standard health education programming, and teachers in the delayed-intervention classes will be asked to refrain from teaching sexual health or MLE during the study timeframe. The primary outcome variables are intentions, willingness, and behaviors related to sexual health and sexual activity. There are currently no evidence-based comprehensive sexual health programs for high school students that are web-based and use an MLE approach. Media Aware has the potential to be an engaging, less expensive, and effective sexual and relationship health program for high school students. Media Aware is unique in two important ways: (1) the web-based format reduces many of the challenges to fidelity of implementation associated with teacher-led sexual health education; and (2) the MLE approach addresses a commonly ignored influence on adolescent sexual and relationship health, namely, media. ClinicalTrials.gov, NCT04035694. Registered on 29 July 2019. Contact for Scientific Queries: Tracy Scull, PhD (Principal Investigator); innovation Research & Training at 5316 Highgate Drive, Suite 121, Durham, North Carolina, USA 27713; tscull@irtinc.us.

    更新日期:2020-01-08
  • Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    P. Coste Mazeau; M. Hessas; R. Martin; J.-L. Eyraud; F. Margueritte; Y. Aubard; C. Sallee; F. Sire; T. Gauthier

    Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery. RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ≥ 18 years of age at > 37 weeks of gestation who exhibit unfavorable cervical conditions (Bishop score < 6) 24 h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality. This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus. Registered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).

    更新日期:2020-01-08
  • Community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India: protocol for a cluster-randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Suchitra Rath; Audrey Prost; Subhashree Samal; Hemanta Pradhan; Andrew Copas; Sumitra Gagrai; Shibanand Rath; Raj Kumar Gope; Nirmala Nair; Prasanta Tripathy; Komal Bhatia; Kelly Rose-Clarke

    Improving the health and development of adolescents aged 10–19 years is a global health priority. One in five adolescents globally live in India. The Rashtriya Kishor Swasthya Karyakram (RKSK), India’s national adolescent health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and girls. Groups aim to give adolescents a space to discuss the social and health issues affecting them and build their capacity to become active community members and leaders. There have been no evaluations of the community component of RKSK to date. In this protocol, we describe the evaluation of the Jharkhand Initiative for Adolescent Health (JIAH), a community intervention aligned with RKSK and designed to improve school attendance, dietary diversity and mental health among adolescent girls aged 10–19 years in rural Jharkhand, eastern India. The JIAH intervention is delivered by a community youth team consisting of yuva saathis (friends of youth), youth leadership facilitators and livelihood promoters. Teams conduct (a) peer-led Participatory Learning and Action meetings with girls and boys, mobilising adolescents, parents, health workers, teachers and the wider community to make changes for adolescent health and development; (b) group-based youth leadership activities to build adolescents’ confidence and resilience; and (c) livelihood promotion with adolescents and their families to provide training and practical skills. We are evaluating the JIAH intervention through a parallel-group, two-arm, superiority, cluster-randomised controlled trial. The unit of randomisation is a geographic cluster of ~1000 people. A total of 38 clusters covering an estimated population of 40,676 have been randomised to control or intervention arms. Nineteen intervention clusters have adolescent groups, youth leadership activities and livelihood promotion. Nineteen control clusters receive livelihood promotion only. Study participants are adolescent girls aged 10–19 years, married or unmarried, in or out of school, living in the study area. Intervention activities are open to all adolescent boys and girls, regardless of their participation in surveys. We will collect data through baseline and endline surveys. Primary trial outcomes are school attendance, dietary diversity and internalising and externalising mental health problems. Secondary outcomes include access to school-related entitlements, emotional or physical violence, self-efficacy and resilience. ISRCTN17206016. Registered on 27 June 2018.

    更新日期:2020-01-08
  • Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial—the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study
    Trials (IF 1.975) Pub Date : 2020-01-08
    Ximena Cid; David Canty; Alistair Royse; Andrea B. Maier; Douglas Johnson; Doa El-Ansary; Sandy Clarke-Errey; Timothy Fazio; Colin Royse

    Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity, and mortality. A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 h of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan, and two-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax, and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission, and healthcare costs. This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants commenced in September 2018 and is estimated to be completed by March 2020. Australian and New Zealand Clinical Trial Registry, ACTRN12618001442291. Registered on 28 August 2018.

    更新日期:2020-01-08
  • Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials
    Trials (IF 1.975) Pub Date : 2020-01-08
    Felix Waibel; Martin Berli; Sabrina Catanzaro; Kati Sairanen; Madlaina Schöni; Thomas Böni; Jan Burkhard; Dominique Holy; Tanja Huber; Maik Bertram; Karin Läubli; Dario Frustaci; Andrea Rosskopf; Sander Botter; Ilker Uçkay

    Few studies have addressed the appropriate duration of antibiotic therapy for diabetic foot infections (DFI) with or without amputation. We will perform two randomized clinical trials (RCTs) to reduce the antibiotic use and associated adverse events in DFI. We hypothesize that shorter durations of postdebridement systemic antibiotic therapy are noninferior (10% margin, 80% power, alpha 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCTs is remission of infection after a minimal follow-up of 2 months. The secondary outcomes for both RCTs are the incidence of adverse events and the overall treatment costs. The first RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 versus 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 versus 4 days for remaining soft tissue infection. The second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 versus 20 days of antibiotic therapy for soft tissue infections; and 3 versus 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Both parallel RCTs will respond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to ensure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. ClinicalTrials.gov, NCT04081792. Registered on 4 September 2019.

    更新日期:2020-01-08
  • Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial
    Trials (IF 1.975) Pub Date : 2020-01-08
    Célia Depaulis; Nadia Steer; Léa Garessus; Dominique Chassard; Frédéric Aubrun

    Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour. This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min or to 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded. We expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment. Primary Registry ClinicalTrials.gov Protocol Registration and Results System Date of Registration 24 June 2016 Unique Protocol ID 69HCL15_0429 Secondary IDs EudraCT Number 2015–003357-17 ClinicalTrials.gov ID NCT02813655 ANSM 160214A-31 Protocol version V4 28/09/2018

    更新日期:2020-01-08
  • Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed
    Trials (IF 1.975) Pub Date : 2020-01-07
    Shaun Treweek; Simon Bevan; Peter Bower; Matthias Briel; Marion Campbell; Jacquie Christie; Clive Collett; Seonaidh Cotton; Declan Devane; Adel El Feky; Sandra Galvin; Heidi Gardner; Katie Gillies; Kerenza Hood; Jan Jansen; Roberta Littleford; Adwoa Parker; Craig Ramsay; Lynne Restrup; Frank Sullivan; David Torgerson; Liz Tremain; Erik von Elm; Matthew Westmore; Hywel Williams; Paula R. Williamson; Mike Clarke

    The evidence base available to trialists to support trial process decisions—e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants—is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process. SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste. This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.

    更新日期:2020-01-07
  • Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis
    Trials (IF 1.975) Pub Date : 2020-01-07
    Ferrán Catalá-López; Rafael Aleixandre-Benavent; Lisa Caulley; Brian Hutton; Rafael Tabarés-Seisdedos; David Moher; Adolfo Alonso-Arroyo

    Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related articles in high-impact-factor medical journals over the past five decades. We conducted a cross-sectional analysis of articles published in the highest ranked medical journals with an impact factor > 10 (according to Journal Citation Reports published in 2017). We searched PubMed/MEDLINE (from inception to December 31, 2017) for all RCT-related articles (e.g. primary RCTs, secondary analyses and methodology papers) published in high-impact-factor medical journals. For each included article, raw metadata were abstracted from the Web of Science. A process of standardization was conducted to unify the different terms and grammatical variants and to remove typographical, transcription and/or indexing errors. Descriptive analyses were conducted (including the number of articles, citations, most prolific authors, countries, journals, funding sources and keywords). Network analyses of collaborations between countries and co-words are presented. We included 39,305 articles (for the period 1965–2017) published in forty journals. The Lancet (n = 3593; 9.1%), the Journal of Clinical Oncology (n = 3343; 8.5%) and The New England Journal of Medicine (n = 3275 articles; 8.3%) published the largest number of RCTs. A total of 154 countries were involved in the production of articles. The global productivity ranking was led by the United States (n = 18,393 articles), followed by the United Kingdom (n = 8028 articles), Canada (n = 4548 articles) and Germany (n = 4415 articles). Seventeen authors who had published 100 or more articles were identified; the most prolific authors were affiliated with Duke University (United States), Harvard University (United States) and McMaster University (Canada). The main funding institutions were the National Institutes of Health (United States), Hoffmann-La Roche (Switzerland), Pfizer (United States), Merck Sharp & Dohme (United States) and Novartis (Switzerland). The 100 most cited RCTs were published in nine journals, led by The New England Journal of Medicine (n = 78 articles), The Lancet (n = 9 articles) and JAMA (n = 7 articles). These landmark contributions focused on novel methodological approaches (e.g. the “Bland-Altman method”) and trials on the management of chronic conditions (e.g. diabetes control, hormone replacement therapy in postmenopausal women, multiple therapies for diverse cancers, cardiovascular therapies such as lipid-lowering statins, antihypertensive medications, and antiplatelet and antithrombotic therapy). Our analysis identified authors, countries, funding institutions, landmark contributions and high-impact-factor medical journals publishing RCTs. Over the last 50 years, publication production in leading medical journals has increased, with Western countries leading in research but with low- and middle-income countries showing very limited representation.

    更新日期:2020-01-07
  • Pilates and dance to patients with breast cancer undergoing treatment: study protocol for a randomized clinical trial – MoveMama study
    Trials (IF 1.975) Pub Date : 2020-01-07
    Leonessa Boing; Tatiana do Bem Fretta; Melissa de Carvalho Souza Vieira; Gustavo Soares Pereira; Jéssica Moratelli; Fabiana Flores Sperandio; Anke Bergmann; Fatima Baptista; Mirella Dias; Adriana Coutinho de Azevedo Guimarães

    Breast cancer is a global public health issue. The side effects of the clinical treatment can decrease the quality of life of these women. Therefore, a healthy lifestyle is essential to minimize the physical and psychological side effects of treatment. Physical activity has several benefits for women with breast cancer, and Pilates solo and belly dancing can be an enjoyable type of physical activity for women with breast cancer undergoing clinical treatment. The purpose of this study is to provide a Pilates solo and a belly dance protocol (three times per week/16 weeks) for women undergoing breast cancer treatment and compare its effectiveness with that in the control group. The participants will be allocated to either the intervention arm (Pilates solo or belly dance classes three times per week for 16 weeks) or a control group (receipt of a booklet on physical activity for patients with breast cancer and maintenance of habitual physical activity routine). The Pilates solo and belly dance classes will be divided into three stages: warmup and stretching, the main stage, and relaxation. Measurements of the study outcomes will take place at baseline; postintervention; and 6, 12, and 24 months after the end of the intervention (maintenance period). The data collection for both groups will occur with a paper questionnaire and tests covering general and clinical information. The primary outcome will be quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image After Breast Cancer Questionnaire), self-esteem (Rosenberg), fatigue (FACT-F), pain (VAS), sexual function (FSFI), and sleep quality (Pittsburgh Sleep Quality Index). In view of the high prevalence of breast cancer among women, the implementation of a specific protocol of Pilates solo and belly dancing for patients with breast cancer is important, considering the necessity to improve their physical and psychological quality of life. Pilates solo and belly dancing are two types of physical activity that involve mental and physical concentration, music, upper limb movements, femininity, and social involvement. An intervention with these two physical activities could offer options of supportive care to women with breast cancer undergoing treatment, with the aim being to improve physical and psychological quality of life. ClinicalTrials.gov, NCT03194997. Registration date 12 August 2017. Universal Trial Number (World Health Organization), U1111-1195-1623.

    更新日期:2020-01-07
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