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At least 469 records · Page 26Linked to original sources
PubMed2004

Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute.

BACKGROUND: Low-radiation-dose spiral CT (LDCT) scanning is capable of detecting lung neoplasms in asymptomatic individuals. To determine whether such detection can reduce lung cancer mortality, a randomized controlled trial (RCT) of LDCT scanning is necessary. METHODS: The feasibility of conducting an RCT in asymptomatic individuals who are at high risk for lung cancer was explored in the Lung Screening Study (LSS), a 12-month special project of the ongoing Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial. During the fall of 2000, six PLCO screening centers recruited a total of 3,318 heavy or long-term smokers who were not participants in the PLCO trial and randomized them to receive either a screening LDCT scan (1,660 participants) or screening posteroanterior view chest radiograph (CXR) [1,658 participants]. RESULTS: The screens were completed on 96% of subjects in the LDCT scan arm and 93% of subjects in the CXR arm. A total of 20.5% of screened subjects in the LDCT scan arm and 9.8% of those in the CXR arm had findings that were suspicious for lung cancer. Thirty lung cancers in subjects in the LDCT arm and 7 lung cancers in patients in the CXR arm were diagnosed following a positive screening result. Additional data from the LSS indicated that, among persons who were at elevated risk for lung cancer, CT scan use was not pervasive, interest in participating in an RCT of LDCT scanning was strong, and few subjects randomized to CXR either refused their examination or sought a CT scan after their study CXR. INTERPRETATION: The results of the LSS demonstrated convincingly the feasibility of an RCT of LDCT scanning in the United States.

Aged↗
PubMed2005

Are psychodynamic and psychoanalytic therapies effective?: A review of empirical data.

There is a need for empirical outcome research in psychodynamic and psychoanalytic therapy. However, both the approach of empirically supported therapies (EST) and the procedures of evidence-based medicine (EBM) have severe limitations making randomised controlled trials (RCTs) an absolute standard. After a critical discussion of this approach, the author reviews the empirical evidence for the efficacy of psychodynamic psychotherapy in specific psychiatric disorders. The review aims to identify for which psychiatric disorders RCTs of specific models of psychodynamic psychotherapy are available and for which they are lacking, thus providing a basis for planning further research. In addition, results of process research of psychodynamic psychotherapy are presented. As the methodology of RCTs is not appropriate for psychoanalytic therapy, effectiveness studies of psychoanalytic therapy are reviewed as well. Studies of psychodynamic psychotherapy published between 1960 and 2004 were identified by a computerised search using Medline, PsycINFO and Current Contents. In addition, textbooks and journal articles were used. Twenty-two RCTs were identified of which 64% had not been included in the 1998 report by Chambless and Hollon. According to the results, for the following psychiatric disorders at least one RCT providing evidence for the efficacy of psychodynamic psychotherapy was identified: depressive disorders (4 RCTs), anxiety disorders (1 RCT), post-traumatic stress disorder (1 RCT), somatoform disorder (4 RCTs), bulimia nervosa (3 RCTs), anorexia nervosa (2 RCTs), borderline personality disorder (2 RCTs), Cluster C personality disorder (1 RCT), and substance-related disorders (4 RCTs). According to results of process research, outcome in psychodynamic psychotherapy is related to the competent delivery of therapeutic techniques and to the development of a therapeutic alliance. With regard to psychoanalytic therapy, controlled quasi-experimental effectiveness studies provide evidence that psychoanalytic therapy is (1) more effective than no treatment or treatment as usual, and (2) more effective than shorter forms of psychodynamic therapy. Conclusions are drawn for future research.

Empirical Research↗
PubMed2001

Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals.

Results of subgroup analysis (SA) reported in randomized clinical trials (RCT) cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author's conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53%) had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94%. Information on whether the SA preceded/followed the analysis was reported in only 7 (41%) of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72%, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported.

Data Interpretation, Statistical↗
PubMed1998

The genetics of renal tumors in end-stage renal failure differs from those occurring in the general population.

The genetics of renal cell tumors (RCT), which occur at a high frequency in patients with end-stage renal failure (ESRF), is not yet known. Using a fluorescence microsatellite assay and comparative genomic hybridization, 18 renal tumors obtained from nine patients with ESRF were analyzed for genetic alterations, which are known to be characteristic of common nonpapillary and papillary RCT in the general population. Deletion of chromosome 3p was detected in six nonpapillary tumors, whereas trisomies of 7 and 17 or 3, 8, and 16 were seen in four of 18 tumors. No alterations were found in four tumors, and another four tumors had unspecific changes. The fragile histidine triad (FHIT) gene is localized at the most common fragile site at chromosome 3p14.2. The FHIT and the p53 tumor suppressor gene are targets of different environmental agents. Because both toxic effect and genomic instability are implicated in the development of renal cysts in ESRF, the alteration of both genes in tumor cells was analyzed. No abnormal expression of the FHIT gene or mutation of the p53 gene were found. This study suggests that the genetics and also the morphology of some of the ESRF RCT differ from those known for RCT in the general population.

Acid Anhydride Hydrolases↗
PubMed1991

Pattern of spread and progression in relation to the characteristics of the primary tumour in human breast cancer.

Characteristics of primary breast tumours were related to the extent of dissemination, the anatomical location of metastases, and the rate of progression in 863 patients with recurrent breast cancer. The following features were examined: tumour laterality, location within the breast, size, invasion of skin or fascia, presence of residual cancer tissue (RCT) in the mastectomy specimen, and number of positive lymph nodes. Increasing tumour size, increasing number of nodes, and the presence of local invasion and RCT were all associated with a short duration of survival both from initial diagnosis and from first recurrence. None of the factors were related to either the extent of dissemination or the rate of progression. Patients who had their primary tumours located in the medial or central part of the breast had an increased incidence of mediastinal and pleural recurrences respectively. Primary tumours greater than 5 cm, invasion of skin or fascia, and presence of RCT were all associated with an increased incidence of local recurrences. In addition, both RCT and fascial invasion were associated with increased occurrence of brain metastases. Most differences were explainable on the basis of local and regional lymphodynamics. Since the status of the features examined here all vary with time from tumour inception, it is suggested that the impact on prognosis is related to variations in tumour age from inception to primary diagnosis rather than to qualitative biological differences.

Bone Neoplasms↗
PubMed1979

[Single photon radioisotope emission computed tomography image using gamma camera (author's transl)].

Single photon radioisotope computed tomography (RCT) images were obtained using the following devices such as conventional gamma camera, data processer for exclusive use of nuclear medicine (C.D.S.-4096), magnetic tape and medium size electronic computer FACOM 230-28S (48K) for multipurposes, which are routinely used for clinical purpose. To reconstruct the RCT image we made absorption correction by geometric mean of opposing counts considering the thickness of source and used the convolution integral method. The reconstructed images of phantom study resolved one centimeter clearly and were very similar to original. The RCT image of patient was acquired by the rotation of patients using the revolving chair and the handmade implement which settles the center of patient's head. Three dimensional informations were obtained by one examination with a gamma camera which collects two dimensional images. When using a gamma camera, therefore, not only a transaxial but an arbitraly RCT image will be important to contribute for diagnosis.

Brain Neoplasms↗
PubMedDate not supplied

Attempting to set up a randomised controlled trial.

AIM: The aim of this article is to provide an account of an attempt to set up a randomised control trial (RCT) to evaluate the effects of programmes of continuing professional education on nursing practice. METHOD: The logistical and methodological challenges of the RCT are described, and an alternative quasi-experimental approach is outlined. RESULTS: It was not possible to obtain a sample of potential students due to the many constraints put on managers, mainly in relation to maintaining staff morale and providing a service while staff are away on courses. CONCLUSION: Few studies into the effects of education on nursing practice adopt a randomised control trial (RCT) methodology. Most continue to be process rather than outcome oriented, focusing on such things as teaching and learning strategies. This might be related to the methodological challenges posed by the RCT when applied in social settings.

Aged↗
PubMed1999

[Side effects of postoperative radiochemotherapy with amifostine versus radiochemotherapy alone in head and neck tumors. Preliminary results of a prospective randomized trial].

PURPOSE: Experimental and clinical data suggest a reduction of radiation-induced acute toxicity by amifostine. We investigated this issue in a randomized trial comparing radiochemotherapy (RCT) versus radiochemotherapy and amifostine (RCT + A) in patients with head and neck cancer. PATIENTS AND METHODS: Forty-seven patients with pharyngeal or laryngeal cancer (T1-2 N1-2 G3, T3-4 N0-2 G1-3) were randomized to receive RCT alone (21 patients) or RCT + A (21 patients). Patients were irradiated up to 60 Gy (R0) or 70 Gy (R1/2). Chemotherapy consisted of 70 mg/m2 carboplatin and was administered over 5 days in the 1st and 5th week of the radiotherapy course. 250 mg amifostine were applied daily just before each radiotherapy session. Acute toxicity was evaluated according to the Common Toxicity Criteria (CTC). As for xerostomia no patients with laryngeal cancer were assessed because in these cases only small volumes of the salivary glands were within the treatment volume. To evaluate the overall toxicity a summarized CTC score of all observed side effects was calculated. RESULTS: Forty-two patients were evaluable. Clinical characteristics (age, sex, Karnofsky index, tumor-staging) were well balanced in both treatment groups (Tables 2 and 3). Amifostine provided reduction in xerostomia and mucositis (Figures 5 and 6) but had no obvious influence on Karnofsky index, body weight, cutaneous side effects and alopecia (Figures 1 to 4). CONCLUSIONS: According to our preliminary results amifostine has a radioprotective effect on salivary glands. Mucositis can be reduced during radiochemotherapy. At this point of patient accrual the difference between both groups are statistically not significant. To improve the radioprotective effects of amifostine in clinical practice the application of a higher dose (> 250 mg) seems to be necessary.

Adenocarcinoma↗
PubMedDate not supplied

Grading the evidence for diabetes performance measures.

CONTEXT: Grading scientific evidence is a critical step in developing practice guidelines and quality performance measures. GENERAL QUESTION: What is the most useful way to grade evidence? SPECIFIC QUESTION: How should we grade the recommended clinical practices for patients with diabetes? STANDARD APPROACH: Hierarchical grading systems (e.g., grades I, II, and III), such as that used by the U.S. Preventive Services Task Force, have traditionally been used to rank the research designs of studies that support a particular clinical practice. POTENTIAL DIFFICULTIES: Many studies that support the clinical practices of diabetes care do not clearly conform to the categories traditionally used in hierarchical grading systems. As a result, there is a tendency to inaccurately characterize the level of evidence, leading to the phenomenon of evidence inflation or evidence deflation. To avoid exaggerating the evidence, important sources of information may be excluded, resulting in an understatement of the available supporting evidence. ALTERNATE APPROACH: This paper offers a more descriptive typologic system that uses the study design and an explanatory modifier to grade the evidence supporting the clinical practices of diabetes care. The study grades are randomized, controlled trial (RCT); RCT-embedded component; RCT-treatment only; RCT-different population; observational study-risk factor; and expert opinion. Using this grading system, the authors were able to more accurately describe the best available evidence supporting the clinical practices of diabetes care.

Diabetes Mellitus↗
PubMed2000

[Evolution in the pharmacological treatment of venous thrombosis according to evidence-based medicine].

Today therapeutic protocols must be in accordance with Recommendations derived by Randomized Controlled Trials (RCT) Evidences. Deep Venous Thrombosis (DVT), post-thrombotic syndrome and pulmonary embolism (PE) are different forms of the thromboembolic venous disease. The Authors, according with Evidence-Based Medicine, review the most significant RCT about Low-Molecular-Weight Heparin (LMWH). It has been proved that LMWH is more efficacious, easier to administrate and with less significant side effects than Unfractioned Heparin (UH) in DVT treatment. Its higher anti-Xa than anti-IIa activity provides higher anti-thrombotic properties and lower haemorrhagic risk. LMWH does not require anticoagulant monitoring and allows outpatient--ambulatory care. RCT also showed lower PE ratio and lower haemorrhagic risk with LMWH outpatient care than with UH in-hospital care for DVT. RCT showed also a long-term lower DVT relapse and PE incidence with LMWH than with oral anticoagulants. The Authors report their own experience with LMWH and early ambulation for the treatment of DVT versus standard UH therapy. Their retrospective analysis confirms lower incidence of complications: growth of the thrombus, severe haemorrhages, PE.

Acute Disease↗
PubMed2001

[Qualitative research methods in clinical practice].

Evidence-based medicine (EBM) corresponds to the physician's ambition to integrate his/her experience with the best current scientific knowledge, applying this integrated proficiency to clinical problems. The concept of EBM has become widely accepted and given rise to a global network usually emphasizing the randomized clinical trial (RCT) as the most important scientific method. However, clinical situations are very complex. To a greater or less extent they are all composed of diverse factors, ranging from bio-medical ones to inter-subjective relations, values and beliefs. In addition to RCT and other quantitative procedures, qualitative scientific methods could be used to explore complex clinical problems. Clinical problems always deserve to be addressed from various perspectives. Unfortunately, RCT has acquired such a dominant position as to give the impression that it is the sole preferred method within the EBM framework. Based on three examples, the present article claims that it is the questions asked by an investigation that should determine one's choice of methods, not the reverse. Consequently, we argue that it is important to remember that RCT is just one out of several potential scientific methods. The respective utility of any one method depends on the clinical issue at hand.

Decision Making↗
PubMed2000

[From aphorism to paradigm - on the development of the randomized clinical trial].

This article focuses on the development and acceptance of the randomized clinical trail (RCT). The emphasis is on the Kuhnian notion of exemplars known as "past scientific achievements" as guidance for paradigmatic research. Three past scientific achievements are introduced belonging to different historical periods. The numerical method was introduced in 1839 in Denmark, but the method was met with strong scepticism, and thus the method did not develop very far. In 1898 a Danish physician, Fibiger, used the statistical method in a clinical investigation studying diphtheria antitoxin. However, the statistical method did not have any remarkable impact on the practicing physicians around the turn of the century. In 1948 the British Medical Research Council published a study on streptomycin using a research design known today as the randomized clinical trial. This study has received a lot of attention and has become "the paradigm" in evaluating therapies. From a Kuhnian perspective, the path leading to the randomized clinical trial has been rather long as it is possible to identify past scientific achievements (or exemplars) leading to the randomized clinical trial belonging to the nineteenth century. Hence, the basic elements in RCT has been known for more than hundred years, but the RCT did not come alive until this century. Different explanations are suggested in order to explain why the RCT "arrived so late", namely the discussion of scientific authority, the conflict between personal acquired knowledge versus universal scientific knowledge and different divergent concepts of disease.

Biometry↗
PubMed2001

Referent cognitions theory: the role of closeness of reference points in the psychology of voice.

The most generally accepted and best documented manipulation in procedural justice experiments is varying whether or not participants are allowed an opportunity to voice their opinion about a decision. To better understand the psychology of voice, the authors focus on Referent Cognitions Theory (RCT). It is argued that thus far RCT has not been used to explain the psychology of voice and that previous RCT research suffers from methodological problems and has been more outcome oriented than necessary. Two experiments resolve these problems and show that people react more strongly to procedures (especially no-voice procedures) when reference points are close as opposed to distant. These findings suggest that closeness of reference points plays an important role in the psychology of voice. The findings expand RCT in significant ways and indicate that insight into the role of reference points is essential for understanding the psychology of justice.

Cognition↗
PubMed2000

[Effect of Panax notoginseng saponins combined isovolumic haemodilution on the retinal microcirculation of patients with retinal vein occlusion].

OBJECTIVE: To study the effect of Panax notoginseng saponins (PNS) or isovolumic haemodilution (IHD) and combination of PNS with IHD on retinal microcirculation of patients with retinal vein occlusion (RVO). METHOD: Seventy three patients with RVO were allocated at random to three groups which were treated with PNS, IHD, or PNS + IHD respectively. The retinal circulation time (RCT) and retinal hemorrhage, edema, leakage of capillary, cystoid macular edema (CME), and nonperfusion area of capillary in retina were observed before and after treatment. RESULT: RCT of patients with RVO was shortened by three treating methods. RCT in the patients who treated by PNS + IHD was the shortest, especially in the patients with nonischemic RVO and branch retinal vein occlusion(BRVO). The retinal hemorrhage, edema, leakage of capillary, and CME in the patients treated by PNS + IHD disappeared quicker than those treated by PNS or IHD. At the same time, the incidence of nonperfusion area in patients whose course of disease was shorter than fourteen days was decreased. The perfusion of capillaries was increased at the edge of nonperfusion area which existed before the treatment. But the effect for nonperfusion area which existed before the treatment in the type of ischemic RVO was not obvious. CONCLUSION: The treatment of PNS + IHD can both shorten RCT of patients with RVO, and promote absorption of retinal hemorrhage, edema, leakage of capillary, and CME. It is possible that PNS + IHD treatment also has an effect to decrease the forming of nonperfusion area in patients whose course of disease is at early stage.

Female↗
PubMed2004

Nonsteroidal antiinflammatory drugs or acetaminophen for osteoarthritis of the hip or knee? A systematic review of evidence and guidelines.

OBJECTIVE: The interpretation of available evidence on the relative efficacy of nonsteroidal antiinflammatory drugs (NSAID) and acetaminophen in osteoarthritis (OA) has recently been debated. This systematic review summarizes the available evidence on the efficacy of NSAID compared to acetaminophen, and compares the quality and content of clinical guidelines regarding the pharmacological treatment of OA. METHODS: Published reports of randomized controlled trials (RCT) and clinical guidelines were identified by a systematic search of bibliographic databases and relevant websites. The quality of RCT was assessed by 2 reviewers independently using a standardized checklist. Data from these RCT were used to calculate pooled differences between groups for pain and disability. The methodology of identified guidelines was appraised using the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument. RESULTS: The search strategy resulted in the identification of 5 RCT. Statistical pooling of data from 3 trials with adequate methods and sufficient data presentation resulted in a pooled standardized mean difference for general pain of 0.33 (95% CI 0.15 to 0.51), indicating a small effect in favor of NSAID. Pooled estimates for other outcome measures were smaller. Three of the 9 identified guidelines satisfied more AGREE criteria than others, particularly regarding rigor of development. Stakeholder involvement, applicability, and editorial independence were poorly described in most guidelines. The content of recommendations regarding the use of NSAID or acetaminophen was fairly consistent. CONCLUSION: Acetaminophen is often effective in OA and is associated with fewer adverse reactions than NSAID. Available evidence supports the recommendations of recent guidelines to use acetaminophen as initial therapy for OA in addition to nonpharmacological interventions. Further research is needed to establish the efficacy of NSAID or acetaminophen in relevant subgroups of patients. We agree with guidelines that it is important that treatment is tailored to individual patients taking into account the severity of symptoms, previous use of acetaminophen, and the patient's knowledge, expectations, and preferences.

Acetaminophen↗
PubMed2005

Clinical inquiries. What is the best treatment for gastroesophageal reflux and vomiting in infants?

The literature on pediatric reflux can be divided into studies addressing clinically apparent reflux (vomiting or regurgitation) and reflux as measured by pH probe or other methods. Sodium alginate reduces vomiting and improves parents' assessment of symptoms (strength of recommendation [SOR]: B, small randomized controlled trial [RCT]). Formula thickened with rice cereal decreases the number of postprandial emesis episodes in infants with gastroesophageal reflux disease (GERD) (SOR: B, small RCT). There are conflicting data on the effect of carob bean gum as a formula thickener and its effect on regurgitation frequency (SOR: B, small RCTs). Metoclopramide does not affect vomiting or regurgitation, but is associated with greater weight gain in infants over 3 months with reflux (SOR: B, low-quality RCTs). Carob bean gum used as a formula thickener decreases reflux as measured by intraluminal impedance but not as measured by pH probe (SOR: B, RCT). Omeprazole and metoclopramide each improve the reflux index as measured by esophageal pH probe (SOR: B, RCT). Evidence is conflicting for other commonly used conservative measures (such as positional changes) or other medications for symptomatic relief of infant GERD. There is very limited evidence or expert opinion regarding breastfed infants, particularly with regard to preservation of breastfeeding during therapy.

Age Factors↗
PubMed2005

Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis.

BACKGROUND: There are fundamental differences in design between phase III clinical trials and phase IV post-marketing studies that involve patient characteristics, the clinical setting (environment) and the manner of drug use. As well, many phase IV studies are extensions of randomized clinical trials (RCTs) and suffer from selection bias. OBJECTIVE: To determine if the data obtained from RCTs of etanercept (Enbrel) in the treatment of rheumatoid arthritis would be representative of the effects attainable in community practice. METHOD: An analysis was conducted comparing data from published RCTs of etanercept use in rheumatoid arthritis patients with data collected in a community based cohort study that was not an extension of an RCT. RESULTS: Baseline clinical data, such as tender or painful joint count, patient's global assessment, the heath assessment questionnaire, physical and mental component summary of the SF-36, and rheumatoid arthritis drug profile were significantly different between the patients receiving etanercept in the phase IV community cohort study and the patients enrolled in the RCTs. Differences in the baseline data for the control patients were also noted amongst the RCT studies. The treatment outcome, American College of Rheumatology (ACR) response rate of 20%, 50% and 70% at 6 month, was the same between the cohort study and the RCTs, but at 12 months the clinical response was less for the community based patients than for the RCT patients. At 6 months there were fewer withdrawals involving community-based patients than RCT patients due to less frequent withdrawals associated with lack of efficacy. At 12 months the withdrawal rate due to either a lack of efficacy or from adverse events was similar between data sets. CONCLUSION: The data from the etanercept phase III RCTs may not reflect the characteristics of patients using etanercept in community practice, nor the clinical outcomes observed by RA patients at 12 months. These discrepancies may be derived from methodological differences in study design and patient selection. On the other hand, outcomes such as withdrawal rates at 12 months appear comparable between the two types of populations.

Antirheumatic Agents↗
PubMed2005

[Investigation of the current situation on clinical application of endodontic treatments in Shanghai municipality].

PURPOSE: To investigate the present state of endodontic treatments applied in Shanghai municipality. METHODS: A questionnaire survey about clinic application of three endodontic treatments including pulp mummification (PM), resinifying therapy(RT) and root canal therapy(RCT) was conducted by 136 dentists of 42 hospitals selected from three different types of hospitals in Shanghai. The questionnaire concerned the proportion and the scale of three treatments used clinically , the indications, the evaluation of the curative effect and the prospective application in future. SAS6.04 statistical software was used for Chi square test and Kruskal-Wallis test. RESULTS: (1) PM and RCT were applied widely, RT was seldom used. There was significant difference in the proportion using PM among three different types of hospitals (P<0.001). (2) PM was primarily applied to the teeth suffering from acute or chronic pulpitis, especially molars with vital pulp.(3)Good long-term curative effect was the primary factor affecting dentists to chose endodontic treatment.(4) Most dentists affirm that the best curative effect would be obtained for RCT, however, the effect was uncertain for PM to treat acute or chronic pulpitis. CONCLUSION: The current situation of clinical use of endodontic therapeutic methods in Shanghai falls some short of the concepts accepted internationally. But in general, RCT should be popularized while PM should be eliminated gradually.

China↗