Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.

Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care.

Abstract: Study Design. A double-blind, randomized controlled trial of a novel educational booklet compared with a traditional booklet for patients seeking treatment in primary care for acute or recurrent low back pain. Objective. To test the impact of a novel educational booklet on patients' beliefs about back pain and functional outcome. Summary of Background Data. The information and advice that health professionals give to patients may be important in health care intervention, but there is little scientific evidence of their effectiveness. A novel patient educational booklet, The Back Book, has been developed to provide evidence-based information and advice consistent with current clinical guidelines. Methods. One hundred sixty-two patients were given either the experimental booklet or a traditional booklet. The main outcomes studied were fear-avoidance beliefs about physical activity, beliefs about the inevitable consequences of back trouble, the Roland Disability Questionnaire, and visual analogue pain scales. Postal follow-up response at 1 year after initial treatment was 78%. Results. Patients receiving the experimental booklet showed a statistically significant greater early improvement in beliefs which was maintained at 1 year. A greater proportion of patients with an initially high fear-avoidance beliefs score who received the experimental booklet had clinically important improvement in fear-avoidance beliefs about physical activity at 2 weeks, followed by a clinically important improvement in the Roland Disability Questionnaire score at 3 months. There was no effect on pain. Conclusion. This trial shows that carefully selected and presented information and advice about back pain can have a positive effect on patients' beliefs and clinical outcomes, and suggests that a study of clinically important effects in individual patients may provide further insights into the management of low back pain. Nonspecific low back pain is a common and recurring symptom that most people usually deal with themselves and for which there is no effective cure. Hence, the information and advice that health professionals give to patients may be a potent element of the health care intervention. Von Korff and Saunders 36 and Bush et al 12 found that one of the main reasons patients consult physicians is to seek information and reassurance. Bush et al 12 suggested that these patients have practical and realistic desires to learn about their low back pain, what to expect, and what they can do about it. There is some evidence that greater congruence among the patient's and clinician's perception of the problem, the prognosis for the disorder, and its long-term management is associated with higher patient satisfaction and better short-term outcomes. 14 Qualitative studies 8,33 have demonstrated the complexity and heterogeneity of patients' perceptions of back pain, which may raise questions about how easily these can be modified by simple information and advice. Deyo and Diehl 18 and Bush et al 12 found that, for patients in the United States, the most frequent reason for dissatisfaction with medical care was failure to receive an adequate explanation of their back pain. Patients who believed that the physician's explanation was inadequate wanted more diagnostic tests, did not cooperate as well with treatment, and had poorer clinical outcomes at 3 weeks. Skelton et al 33 found that patients in the United Kingdom were skeptical of medical explanations for their back pain either because they doubted its validity or because it did not fit their own understanding of the problem. Borkan et al 8 found that Israeli patients also were quite critical of the medical system and more interested in what works. The first U.S. and U.K. clinical guidelines for acute low back pain 3,16 recommended that patients should be given accurate and up-to-date information and advice about back pain and its management; however, that recommendation was based on theoretical considerations and general clinical consensus rather than on any firm scientific evidence that such information improves outcomes. These guidelines gave few practical details on precisely what the content of that information and advice should be, apart from general reassurance about the absence of serious disease and that most back pain improves quickly with simple symptomatic measures and activity modification. There has been a progressive shift in subsequent international guidelines. 10 Based on additional evidence that is now available, 40 the more recent U.K. 31 and New Zealand 2 guidelines suggest that the physician provide more positive advice to stay active and continue ordinary activities as normally as possible. The New Zealand guidelines also provide a detailed assessment of psychosocial yellow flags (risk factors for chronic pain and disability) and suggest general behavioral principles for how patients with these features should be managed. 23 Discussion at the Second International Forum for Primary Care Research on Low Back Pain 9 identified the continuing need for a simple and convincing explanation of back pain that is acceptable to patients and that would form a logical basis for active management. Most guidelines recommend that printed educational material should be made available, though this recommendation is based on limited evidence. 10 There are hundreds of leaflets and booklets about back pain, but remarkably few have been submitted to any sort of scientific evaluation. 11 Roland and Dixon 28 reported on the only randomized controlled trial (RCT) of a traditional clinical booklet that showed any significant impact on patients: those receiving the booklet consulted less frequently and had fewer specialist referrals for back pain over the next year. Cherkin et al 15 reported on an RCT that compared a 15-minute session with an educational nurse with a booklet that was similar to the material accompanying the Agency for Health Care Policy and Research (AHCPR) guidelines. 3 The nurse intervention yielded higher patient satisfaction, perceived knowledge, and exercise participation in the short term. The booklet showed similar trends, but they did not reach statistical significance compared with the outcomes of usual care. Neither of these trials showed any effect of a booklet on pain or functional status. The aim of the current study was to determine the impact of a novel educational booklet on the beliefs and functional outcome of patients seeking treatment in primary care for an acute or recurrent episode of low back pain.

A perspective on the three large multicenter randomized clinical trials of coronary bypass surgery for chronic stable angina.

Abstract: Myocardial ischemia is an important determinant of survival in patients with coronary artery disease (CAD) and it may be silent. Coronary bypass surgery (CBS) is more effective than medical treatment in the relief of myocardial ischemia, anginal pain, and of events that are related to myocardial ischemia such as episodes of angina and left ventricular dysfunction caused by ischemia. Patients with chronic, stable angina assigned to CBS have an improved survival if they have left main CAD, three-vessel CAD with normal or impaired left ventricular function, proximal left anterior descending CAD that is part of two-vessel CAD, or two- or 3-vessel CAD with a positive exercise test for ischemia. In other respects, patients assigned to medical therapy fare as well as or better than those assigned to surgical therapy. Many issues that cause concern with regard to the randomized trials were considered in detail. The greatest problems are biostatistical tenets, small numbers of patients randomized in many of the subgroups, physician bias before and after randomization, crossovers, and inappropriate conclusions and unjustified extrapolations of the results. Timely, detailed, and comprehensive publication of the methods and results of these clinical trials is necessary. Meticulous, detailed, and critical reading of all of the published data is urged.

Randomized, Double-Blind, Placebo-controlled Study of Brodalumab, a Human Anti–IL-17 Receptor Monoclonal Antibody, in Moderate to Severe Asthma

Abstract: Rationale: IL-17 signaling has been implicated in development and persistence of asthma. Cytokine-targeted strategies blocking IL-17 receptor signaling may be beneficial in asthma treatment.Objectives: To determine efficacy and safety of brodalumab, a human anti–IL-17 receptor A monoclonal antibody, in subjects with inadequately controlled moderate to severe asthma taking regular inhaled corticosteroids.Methods: Three hundred two subjects were randomized to brodalumab (140, 210, or 280 mg) or placebo. Primary endpoint was change in Asthma Control Questionnaire (ACQ) score from baseline to Week 12. Secondary endpoints included FEV1, symptom scores, and symptom-free days. Prespecified subgroup analyses were conducted to identify potential responsive subpopulations. Analyses included randomized subjects receiving one or more doses of investigational product using last-observation-carried-forward imputation.Measurements and Main Results: Demographics and baseline characteristics were generally balanced among ...

Systematic Review of Psychological Therapies for Cancer Patients: Overview and Recommendations for Future Research

Abstract: Many cancer patients use psychological therapies because they expect them to cure their cancer or to improve their recovery. Despite these high expectations, both patients and oncologists report being moderately to very satisfied with the results of psychological therapies. Previous reviews of the literature have concluded that psychological therapies may help cancer patients in various ways, ranging from reducing the side effects of cancer treatments to improving patients' immune function and longevity. However, because those reviews lacked methodologic rigor, we critically and systematically reviewed all identifiable publications about psychological therapies used by cancer patients to provide an objective and scientific evaluation of nontraditional therapies. We identified 627 relevant papers that reported on 329 intervention trials by searching MEDLINE, Healthplan, Psychlit, and Allied and Complementary Medicine databases and in the bibliographies of the papers identified. Despite increased use of randomized, controlled trial designs over time, the methodologic quality of the intervention trials, on 10 internal validity indicators, was generally suboptimal, with only one trial achieving a quality rating of "good" for its methodology. Using effectiveness results from 34 trials with psychosocial outcomes, 28 trials with side effect outcomes, 10 trials with conditioned side-effect outcomes, and 10 trials with survival or immune outcomes, we make only tentative recommendations about the effectiveness of psychological therapies for improving cancer patients' outcomes. Nevertheless, by exploring the relative effectiveness of the different intervention strategies for each outcome and follow-up period, we suggest the specific therapies that should be considered for further investigation. In addition, we suggest how future trials can maximize their internal validity by describing the minimal reporting standards that should be required in this field.