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Results for “Randomized Controlled Trials as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 235 records · Page 13Linked to original sources
PubMed2005

Efficacy of interventions in improving adherence to antiretroviral therapy.

The aim of this paper is to perform a critical review of the effectiveness of interventions for the purpose of enhancing adherence to antiretroviral therapy. The overall evaluation indicates that research is in its early stages. Although pilot studies provide support for the feasibility of their protocols, and preliminary results also suggest their capacity to improve adherence, only three major trials have reported significant improvement in adherence. The issues that will have to be addressed by future studies include: (a) the need for a theoretical and empirical understanding of the phenomena; (b) adoption of a format that fits the attributes of the population; (c) the use of multiple strategies involving key providers; (d) a concise and precise schedule governing the frequency and intensity of the intervention; (e) a careful selection of direct outcome; and (f) appropriate time measurement. In sum, greater efforts to design and evaluate interventions are needed to lead to an increase in adherence and improvement in treatment effectiveness.

Anti-Retroviral Agents↗
PubMed1994

Should we reestablish the Lung Cancer Study Group?

The hallmark of the Lung Cancer Study Group (LCSG) was its multidisciplinary approach to cancer management, based on close collaboration among thoracic surgeons, medical oncologists, radiation oncologists, pathologists, biostatisticians, and data managers. Discontinuation of funding for the group dispersed a critical mass of thoracic oncologists and had serious adverse effects on clinical trials in early-stage thoracic malignancies, on translational research, and on oncologic education. The use of an intergroup mechanism for clinical trials has been partially successful in continuing the work started by the LCSG, but a sustained effort will be necessary to recreate the framework for clinical investigation provided by the group.

Clinical Trials as Topic↗
PubMed2002

Recent advances in implantable cardioverter defibrillator systems.

The usefulness of the implantable cardioverter defibrillator (ICD) for the prevention of sudden cardiac death caused by ventricular tachyarrhythmias has been proven by several international randomized multi-center clinical trials. Recent advances in medical technologies, such as size reduction and the functional improvements of the device, have resulted in relatively easy implantation. As a result, the number of ICD recipients has been rapidly increasing and the indications for ICD implantation have been expanding. Dual chamber ICDs offer improved tachyarrhythmia detection algorithms such as discrimination of supraventricular arrhythmias. In Europe and the United States, biventricular ICDs are now available for the treatment of congestive heart failure associated with ventricular tachyarrhythmias. Although the incidence of inappropriate shock by ICDs is decreasing, inappropriate discharges of ICDs and a declining quality of life are still problems.

Clinical Trials as Topic↗
PubMed1999

High-dose therapy for breast cancer.

In recent years, the most frequent indication for high-dose autologous stem-cell-supported chemotherapy in the United States has been breast cancer. This approach is applied in "high-risk," early-stage disease as adjuvant treatment, and with either curative or palliative intent in metastatic disease. Among both lay persons and medical professionals, high-dose therapy is broadly viewed as standard and appropriate, even though the results of the largest prospective randomized studies are not yet available. This view is based on extrapolation from preclinical data, a fundamental belief that "more is better," a faith in high technology, and the results of numerous pilot and phase I and II trials. Because high-dose therapy is promising, but also more difficult to administer than standard therapy, controversy rages in all circles concerning its use. Unless and until we have the results of properly randomized, prospective studies, this controversy will likely continue. Against this background, we will review the theoretical basis for high-dose treatment in breast cancer, the translation of this laboratory science into the clinic, usual treatment approaches, the available data, ongoing clinical trials, and future research directions.

Antineoplastic Agents↗
PubMed2006

Sublingual immunotherapy: efficacy--methodology and outcome of clinical trials.

Using Medline we identified 39 placebo-controlled, double-blind sublingual immunotherapy (SLIT) studies providing symptom-medication score. These were retrospectively evaluated for evidence of clinical efficacy and quality of study presentation. Clinical efficacy was estimated according to statistical significance and graded as: unequivocal efficacy (statistically significant difference from placebo in both symptom and medication scores or the combined score), which was observed in 28% of studies, possible efficacy (significant improvement in either symptom or medication scores) seen in 33%, and no efficacy (no statistical difference between active treatment and the placebo group), as found in 38% of studies. Generally, studies were limited by the number of patients, showed a high frequency of withdrawals, a short duration of treatment, and insufficient data on randomization. The magnitude of efficacy additional to placebo treatment must be >20% in order to justify the treatment. This review concludes that future SLIT studies should be planned in accordance with international recommendations in order to be conclusive.

Administration, Sublingual↗
PubMed1999

Overview of JNC VI: new directions in the management of hypertension and cardiovascular risk.

Treatment recommendations for hypertension as outlined in the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) are constantly evolving and being refined as new information on the disease becomes evident. Uncontrolled hypertension is a major antecedent of stroke, heart failure, coronary heart disease, and end-stage renal disease. The increasing incidences of both cardiovascular and renal diseases fuel the need for improved control of hypertension. In fact, according to the National Health and Nutrition Examination Survey (NHANES), about 69% of Americans whose blood pressure is greater than 140/90 mm Hg are aware of it, about half are getting treatment for it, and only about one-quarter are adequately controlled. These observations fuel the need for improved patient management guidelines. JNC VI makes several changes from the previous JNC V to assist physicians in the diagnosis, treatment, and improved management of patients with hypertension. These changes include reporting adult blood pressure in two new ways, via staging and risk factor classification. A high-normal classification (systolic: 130 to 139 mm Hg, or diastolic: 85 to 89 mm Hg) is included in JNC VI because of the clinical importance of such blood pressure contributing to cardiovascular disease. Additionally, clinicians are advised to assign a patient to one of three risk categories that, in addition to hypertension stage, influence the decision to select antihypertensive drug therapy. Lifestyle modification is an important component at each stage. These and other changes and highlights of recent studies supporting the need for more intensive blood pressure control are discussed in this paper.

Adolescent↗
PubMed2000

[Guidelines for diagnosis and treatment of sore throat].

BACKGROUND: Available guidelines for the diagnosis and treatment of sore throat give conflicting recommendations. Our aim was to develop evidence-based guidelines. MATERIAL AND METHODS: We searched The Cochrane Library, Medline and other sources for systematic reviews and other evidence that met explicit inclusion criteria for all of the relevant options and outcomes we identified. The validity of included studies was assessed. Draft recommendations based on assessment of this evidence were widely circulated and discussed in focus groups with patients and physician assistants. RESULTS: Throat infections are self-limiting and complications rare. Penicillin shortens the duration of symptoms in tonsillitis caused by beta-haemolytic streptococci and reduces the risk of complications. Penicillin has adverse effects and increases the risk of reinfections. Patients with sore throat should usually be treated without antibiotics. Visiting a physician is normally unnecessary. Antibiotics should be considered in serious cases or if the patient prefers this, but should only be prescribed for throat infections caused by beta-haemolytic streptococci. The diagnosis should be based on clinical criteria and a rapid antigen test in cases of doubt. INTERPRETATION: Benefits of antibiotics must be weighed against harms. Patients should be given good information and involved in decision/making if they want antibiotics.

Anti-Bacterial Agents↗
PubMed2004

The classic caries clinical trial: constraints and opportunities.

The history of clinical trials would include events in 1747 on board the Salisbury, a British Navy vessel at sea with 12 seamen critically ill with scurvy. Involving these 12 sailors in a study, an officer on board by the name of Lind evaluated six potential treatments for scurvy, and rapidly reached the conclusion that daily consumption of citrus fruits returned the men fit for duty in approximately six days (Bull, 1959). The concept of experimental randomization was first developed by Sir R.A. Fisher (1925, 1926), and the method was introduced to medical research via a study of tuberculosis treatment by Amberson and co-workers (1931), who randomized 24 TB patients into two groups, one to receive the experimental therapy, the other serving as the control. Amberson et al. also incorporated the concept of blinding into their study. Sir Austin Bradford Hill codified and built on the principles of scientific experimentation developed by Fisher, and introduced the use of random numbers in the allocation of patients in the British Medical Research Council (1948) study of the effect of streptomycin in the treatment of tuberculosis (Daniels and Hill, 1952; Hill, 1952). The first applications of clinical trial methodology for testing interventions on dental, oral, and maxillofacial diseases and conditions are more difficult to determine. For dental caries prevention, however, Chilton and Fertig (1958) and Slack and Martin (1964) were certainly among the early caries clinical trial pioneers. As clinical trials have come into the mainstream of clinical research in medicine and dentistry, a great deal of developmental work has focused on their methodological enhancement. The most successful of these efforts have come from fruitful, ongoing collaborations among clinician investigators, biostatisticians, data management specialists, biomedical ethicists, and others with an academic interest in clinical trial design and utilization. During the past 25 years, the emergence of systematic reviews and the evidence-based medicine (EBM) movement have also contributed significantly to the increasing reliance on randomized clinical trial outcomes for the advancement of better clinical practice (Richards et al., 1997; Straus and Sackett, 1998; www.cochrane.org/cochrane/ccbroch.htm#BDL, 2002).

Clinical Trials as Topic↗
PubMed1999

Randomized clinical trials in HEPATOLOGY: predictors of quality.

Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998. Quality was assessed by means of a validated 5-point scale and separate quality components associated with empirical evidence of bias. Only 26% of all RCTs reported sample size calculations, 52% adequate generation of the allocation sequence, 34% adequate allocation concealment and 34% double-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate portal hypertension (odds ratio [OR]: 2.4; 95% CI: 1.1-5.5; P =.03), be multicentered (OR: 3.4; 95% CI: 1.3-8.9; P =.01), sponsored by public organizations (OR: 4.2; 95% CI: 2.1-8.6; P =.0001), or the drug and device industry (OR: 4.7; 95% CI: 2.2-10.2; P =.0001) compared with other therapeutic areas, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers involved and external funding.

Bias↗