Trials
-
Over the past three decades it has become increasingly recognized that systematic assessment of as high a proportion as possible of relevant research evidence is needed to protect the best interests of patients and the public. For example, this principle is manifested in clinical guidelines and, increasingly, in the design and monitoring of new research. For scientific and ethical reasons, those responsible for monitoring the progress of ongoing clinical trials may need to seek unpublished and interim data to protect the interests of actual or potential participants in research. ⋯ In this paper we review some of the commentaries on the issue and the few accounts of actual data monitoring committee experiences. We then present details of our own recent experience as members of the data monitoring committee for the BOOST-II UK trial (ISRCTN:0084226), one of five concurrent trials assessing the level of arterial oxygen which should be targeted in the care of very premature neonates. We conclude that efficient protection both of the interests of actual or potential participants in research and of science requires that data monitoring committees have access to all relevant research, including unpublished and interim data.
-
Randomized Controlled Trial Multicenter Study
Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial.
Neck pain caused by cervical spondylosis has become a common health problem worldwide among >40-year-old adults. Acupuncture intervention is one of the most popular treatment measures for this disorder. However, evidence for its efficacy in relieving neck pain and recovering neck physiological function has not been established in randomized, placebo-controlled trials. The primary aim of this trial is to assess the efficacy and safety of active acupuncture compared with sham acupuncture intervention for neck pain caused by cervical spondylosis. ⋯ This paper describes the rationale and design of a randomized double-blind, placebo-controlled trial that aims to determine the efficacy and safety of acupuncture intervention for neck pain caused by cervical spondylosis. The primary outcomes are changes in the NPQ score and neck physiological function. Secondary outcome measures include quality of life, adverse events, and relapse of neck pain. If successful, this project will provide evidence of the efficacy and safety of acupuncture for neck pain caused by cervical spondylosis.
-
Randomized Controlled Trial Multicenter Study
FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial.
Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia. ⋯ Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative.The primary analysis tests for differences between the therapy group and an untreated (waiting list) control group with respect to pre- versus post 3-week-therapy (or waiting period, respectively) scores on the ANELT A-scale. Statistical between-group comparisons of primary and secondary outcome measures will be conducted in intention-to-treat analyses.Long-term stability of treatment effects will be assessed six months post intensive SLT (primary and secondary endpoints).
-
Randomized Controlled Trial Multicenter Study Comparative Study
Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients.
Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy. ⋯ The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.
-
Randomized Controlled Trial Multicenter Study
Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial.
Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN. ⋯ The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.