Contemporary clinical trials
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Contemp Clin Trials · Aug 2006
ReviewReview of randomised trials using the post-randomised consent (Zelen's) design.
In 1979, Zelen described a trial method of randomising participants before acquiring consent in order to enhance recruitment to clinical trials. The method has been criticised ethically due to lack of consent and scientifically due to high crossover rates. This paper reviews recent published trials using this method and describes the reasons authors gave for using the method, examines the crossover rates, and looks at the quality of identified trials. ⋯ The most important reason stated by authors for using Zelen's method was to limit bias. Zelen's method, if carefully used, can avoid 'resentful demoralisation' and the Hawthorne effect biasing a trial. Unlike a previous review, we found that crossover was not a problem for most trials.
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Contemp Clin Trials · Aug 2006
Randomized Controlled Trial Multicenter StudyTotal laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial.
Endometrial cancer is the most common gynaecological malignancy in Australia and the US. Current standard treatment involves open surgery to remove the uterus, and both tubes and ovaries (TAH). The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was designed to assess equivalence of performing this in a total laparoscopic approach (TLH). ⋯ The LACE trial will establish the equivalence of a TLH approach for patients with stage 1 endometrial cancer following a two stage protocol to accommodate potential threats to patient recruitment through requests for laparoscopic surgery.
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Contemp Clin Trials · Jun 2006
Center for clinical studies in a surgical department--an approach for more evidence-based medicine.
The concept of evidence-based medicine (EBM) has been introduced into the field of surgery in Germany since 1996, initially focussing on the application of the classical five-step-concept of EBM to the individual patient. Despite the international efforts of the Cochrane Collaboration, few systematic reviews address surgical procedures and the number of high quality randomized-controlled trials (RCTs) are low. External evidence in surgery is a major problem and requires new strategies in research and patient care. ⋯ Since May 2002 1808 patients have been enrolled into a total of 38 pharmaceutical (19 trials with 470 patients enrolled) and investigator initiated (19 trials with 1338 patients enrolled) studies. Second, the clinical site develops and conducts surgical efficacy RCTs and follows new standards including publication and registration of the protocols. Within 3 years it was possible to change practice in an academic setting from the traditional concept to an evidence-based approach.
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Contemp Clin Trials · Apr 2006
Investigating placebo effects in irritable bowel syndrome: a novel research design.
Little is known about placebo effects with scientific precision. Poor methodology has confounded our understanding of the magnitude and even the existence of the placebo effect. Investigating placebo effects presents special research challenges including: the design of appropriate controls for studying placebo effects including separating such effects from natural history and regression to the mean, the need for large sample sizes to capture expected small effects, and the need to understand such potential effects from a patient's perspective. This article summarizes the methodology of an ongoing NIH-funded randomized controlled trial aimed at investigating whether the placebo effect in irritable bowel syndrome (IBS) exists and whether the magnitude of such an effect can be manipulated to vary in a manner analogous to "dose dependence." The trial also uses an innovative combination of quantitative and qualitative methods.
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Contemp Clin Trials · Feb 2006
Randomized Controlled Trial Comparative StudyA pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care-methodology of the Palliative Care Trial [ISRCTN 81117481].
The demand for palliative care is increasing, yet there are few data on the best models of care nor well-validated interventions that translate current evidence into clinical practice. Supporting multidisciplinary patient-centered palliative care while successfully conducting a large clinical trial is a challenge. The Palliative Care Trial (PCT) is a pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial that tests the ability of educational outreach visiting and case conferencing to improve patient-based outcomes such as performance status and pain intensity. ⋯ The interventions are aimed at translating current evidence into clinical practice and there was particular attention in the trial's design to addressing common pitfalls for clinical studies in palliative care. Given the need for evidence about optimal interventions and service delivery models that improve the care of people with life-limiting illness, the results of this rigorous, high quality clinical trial will inform practice. Initial results are expected in mid 2005.