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PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗

PubMed1998

Understanding the mechanism of LCAT reaction may help to explain the high predictive value of LDL/HDL cholesterol ratio.

Traditionally, lecithin:cholesterol acyltransferase (LCAT) role in the reverse cholesterol transport (RCT) has been considered "antiatherogenic" as the cholesterol esterification is the prerequisite for the formation of mature high density lipoprotein (HDL) particles and may create a gradient necessary for the flow of unesterified cholesterol (UC) from tissues to plasma. However, newer data suggest that a higher esterification rate is not necessarily protective. Here we review the available data on the role of LCAT in RCT and propose that the LCAT-mediated esterification of plasma cholesterol promotes RCT only in the presence of sufficient concentrations of HDL2 while this reaction may be atherogenic in the presence of high concentration of plasma low density lipoprotein (LDL) cholesterol Thus, the "protective" or potentially "atherogenic" role of LCAT depends on the quality of HDL and concentration of LDL. This hypothesis is consistent with the known high predictive value of LDL/HDL cholesterol ratio.

Animals↗

PubMed2000

[Tumor microcirculation and selective enhancement of drug delivery--clinical applications based on pathophysiological experiments].

Tumor tissue is composed of cancer cells (parenchyma) and tumor vessels (interstitium). Many investigators have pointed out that blood flow in tumors has a very inhomogenous distribution, and that this inhomogeneity in blood flow increases as tumors grew. This would be a certain cause of insufficient drug delivery to tumor tissues. Among the experimental evidence using Yoshida Sarcoma and Ascites Hepatomas, functional differences in microcirculation between tumor and normal tissues were found by Suzuki et al. (1977). Under hypertensive state induced by the continuous infusion of angiotensin II, tumor blood flow increased remarkably, while there was no change or decrease in blood flow in normal tissues such as the brain, bone marrow, liver and kidney. Moreover, the increase in blood flow in tumors was selective, as the mean blood pressure remained at the level of 150 mmHg. Increases were confirmed not only in many growing sites such as in the liver, muscle, subcutis, and even microfoci, but also in various kinds of xenografted human tumors and autochthonous tumors. Augmentation of the anti-tumor effects of angiotensin II-induced hypertension chemotherapy (IHC) for advanced gastric carcinoma was revealed in two randomized controlled trials (RCT-1 & 2) of collaborative study groups in Japan. The response rates were 42.9% vs 10.5% in RCT-1 and 31.3% vs 6.7% in RCT-2. The frequencies of toxicities were not statistically different. In the results of phase II studies from 1978 to 1994 (OPN-1) and 1995 to 1999 (OPN-2) for advanced gastric carcinoma (GC), the response rates were 37.9% and 35.7%. Down staging in which the conclusive stage score was lower than the score of the clinical stage, was observed in 8 out of 94 cases (19%) with primary lesions in total and in 30 patients (63%) receiving reduction surgery after IHC, since 1978. It is very important for exact evaluation after chemotherapy to understand or estimate the pathohistological changes in the tumor and its degenerated or repaired tissues, which present various clinical images. In the present study, the actual administered dose intensity of adriamycin (aDIadm) was 5.9 +/- 2.4 mg/sqm/w, and the ratio of aDIadm to the proposed DIadm of reported FAM/FAP schedules was 0.78 +/- 0.32. IHC with smaller DI could lead to a reduction in the accumulation of toxicities of anti-cancer drugs in the host. In conclusion, IHC might be applied to all kinds of tumors to enhance the chemotherapeutic effects through selective increase of drug delivery to tumors.

Animals↗

PubMed2000

[Genetic risk of families with t(1;2)(q42;q33) GTG, RHG, QFQ, FISH].

OBJECTIVES: A central concept in genetic counseling is the estimation of the probability of recurrence of unfavourable pregnancy outcomes (abortion, stillbirth and birth at malformed child). In case of chromosomal changes estimates are made on basis of segregation analyses in actual pedigree. If we have a few of pedigree members than risk estimate should be performed on basis combined our data and empiric data from literature. We present individual genetic risk for carriers of unique reciprocal translocation t(1;2)(q42;q33) detected through karyotyping of the patient with miscarriage. MATERIAL AND METHODS: The pedigree consisted 5 families of t(1;2)(q42;q33) carriers with 15 members of progeny was evaluated according to Stene and Stengel-Rutkowski. Cytogenetic analysis of persons of these families (7 persons) was performed on blood samples using GTG, RHG, QFQ and FISH techniques. Additional RCT pedigree analysis of Stengel-Rutkowski et at Collection, Polish Collection, Lituanian Collection, Bielorussian Collection and an available literature cases were performed. RESULTS: The translocation was classified as translocation at risk for double segment imbalances for trisomy 1q42-->qter together with monosomy 2q33-->qter or monosomy 1q42-->qter together with trisomy 2q33-->qter after 2:2 disjunction after adjacent-1 segregation of the meiotic chromosomes. Two improved risk values for RCT with segments 1q42-->qter, 2q33-->qter were obtained i.e. 6/44 (13.6% +/- 5.2%) and 4/20 (20% +/- 8.9%). The probability of occurrence for this translocation carriers was estimated as 7% (medium risk). On basis of direct analysis at presented pedigree a risk for miscarriage was estimated as 2/9. CONCLUSIONS: 1. Carrierships of t(1;2)(q42;q33) increased population risk value for unbalanced progeny at birth by 7% (medium risk) and for miscarriage 2/9. 2. Causative relation between presence of t(1;2)(q42;q33) and miscarriages is suggested. 3. Updated, new genetic risk values for RCT at risk for single segment 1q42-->qter imbalance is 6/44 (13.6% +/- 5.2%) at birth and for single segment 2q33-->qter imbalance is 4/20 (20% +/- 8.9%).

Abortion, Spontaneous↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗

PubMed1976

Studies on the characteristics of Poliovirus type 3. III. Strain characteristics after passage in man.

The markers d, IST, EA1(OH)3 and rct at sub- and supraoptimal temperatures as well as neurovirulence (PMic) for monkeys was determined for strains isolated from children vaccinated with Leon 12a1b vaccine, their contacts and from paralytic cases. The strains were isolated at early and late phases of excretion. The changes concerned mainly rct determined at supraoptimal temperatures, d and PMic markers, especially in strains isolated at the late phase of excretion. The passage through the human alimentary tract did not change such markers as IST and EA1(OH)3. Some degree of correlation was observed between the rct 40.3, d and PMic markers.

Animals↗

PubMed2001

A Kantian claim permitting the randomised clinical trial.

Among the most contested aspects of medical research is the randomized clinical trial (RCT). While the majority of arguments justifying the RCT and its use in medical research rest within a utilitarian framework, many Kantians claim that a deontological ethical framework is prohibitive of the use RCTs in medical research. This paper argues that, in fact, the RCT is permissible within a deontological framework.

Ethical Theory↗

PubMed2002

[Possibilities of x-ray computed tomography in the diagnosis and treatment of suppurative complications of acute pancreatitis].

The authors have analyzed results of the roentgen computed examination of 73 patients with acute pancreatitis and its complications. The potentialities of roentgen computed tomography (RCT) in diagnosing are shown as well as computed semiotics of acute pancreatitis and its complications. The authors consider that RCT makes the diagnosis substantially more exact and enables the complications to be detected much earlier. Systematization of the signs detected by RCT in acute pancreatitis in combination with the clinical symptoms gives the information necessary for correct strategy of surgical treatment.

Acute Disease↗

PubMed2003

Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus.

OBJECTIVE: To appraise systematically the study design and quality of reporting of randomized controlled trials (RCT) on systemic lupus erythematosus (SLE) and to identify potential defects and biases. METHODS: RCT with at least 5 patients with SLE were retrieved from MEDLINE, EMBASE, and the Cochrane Library. We analyzed study design, quality of reporting, and trial results. RESULTS: Ninety-four trial reports (37 on lupus nephritis) were eligible with 2,257 SLE patients (n = 795 in lupus nephritis trials). Median sample size was 28 patients. Fifty-one trials (54.3%) were double blind, but only 31 (33.0%) mentioned the randomization mode, only 19 (20.2%) described allocation concealment, and only 7 (7.5%) were adequately powered. Sixty-three trials (67%) described adequately reasons for withdrawals. Nephritis trials had on average longer followup (p = 0.001) and were less likely to be double blind (p < 0.001), to describe reasons for withdrawals [both overall (p = 0.008) and per arm (p = 0.009)] and to involve a comparison against placebo or no treatment (p < 0.001). Larger trials scored higher on several quality characteristics. Significant efficacy or trend for efficacy was claimed in 72 reports (76.6%) and this was even more common in trials published in 1999-2002 (89.5%). Significant efficacy was found more frequently in trials that clearly specified withdrawals per arm (p = 0.001) and outcomes (p = 0.001) and used intention-to-treat analyses (p = 0.03). Besides outcome specification, no other quality variables seemed to improve significantly over time. CONCLUSION: Several aspects of the design and reporting of RCT on SLE can be improved. Larger, adequately powered, and accurately reported trials are needed.

Bias↗

PubMed2003

Applicability of clinical trial results to the individual patient: practice guidelines.

Randomized controlled trials (RCTs) constitute the methodological gold standard to generate therapeutic or preventive evidence. Diagnostic or prognostic evidence is given by studies with different designs, rather than RCTs. Given the structural design that a RCT must present to be valid--discussed in previous issues of the Journal--one major question is the applicability of trial results to populations or individual patients that are different from those analyzed in that trial. In other words, how does the cardiologist know whether to apply a specific treatment--whose efficacy and risk profile have been defined in a good quality RCT, i.e. one with valid and important results--to his/her individual patient? The simplest solution would be found in the answer to the question: "Could my patient have been enrolled in the study by satisfying its inclusion and exclusion criteria?" If the answer is "yes", then it would be sound to apply the study results to the patient, so long as it is done carefully. If the answer is "no" (because the patient presents different demographic features or serious comorbidities not found in the trial subjects, for example), then transfer of the therapeutic results from the trial would be seriously compromised. The evaluation of these questions is complex and, due to its importance, deserves a systematic approach. In this article we will present some practical guidelines on whether to reject the applicability of RCT results to patients who are different from those included in the trial.

Clinical Trials as Topic↗

PubMed2003

[Future perspectives on the standardization of surgical treatment for esophageal cancer].

The Japanese Society for Esophageal Diseases published guidelines for the treatment of esophageal cancer in December 2002. Radical surgery is indicated for T1N1 and T2,3 disease without M1 metastasis to other organs, which consists of transthoracic esophagectomy through the right chest with mediastinal and abdominal (two-field), and cervical if necessary (three-field) resection, lymphadenectomy, and esophageal reconstruction by pulling up the stomach. The survival benefit of cervical lymphadenectomy remains controversial. A randomized, controlled trial (RCT) comparing two-field and three-field resection is needed to evaluate the efficacy of cervical lymphadenectomy. In the West, especially in the USA, surgeons prefer transhiatal esophagectomy, which is illogical in cancer surgery, rather than transthoracic esophagectomy. A recent Dutch RCT comparing transhiatal and transthoracic esophagectomy reported lower morbidity and a trend toward improved long-term survival in the transhiatal group. Minimally invasive surgery for esophageal cancer is common in clinical practice today. However, there is little evidence showing that less-invasive procedures are superior to radical surgery. Further investigation is needed to determine the efficacy of thoracoscopic esophagectomy and laparoscopic mobilization of the stomach for esophageal replacement. The efficacy of neoadjuvant chemotherapy and chemoradiotherapy also remains controversial. However, the effectiveness of adjuvant chemotherapy after surgery on disease-free survival was confirmed by the Japanese Clinical Oncology Group RCT.

Digestive System Surgical Procedures↗

PubMed2003

SysBank: a knowledge base for systematic reviews of randomized clinical trials.

The Systematic Review Bank (SysBank) is a structured knowledge base that captures information about the design, execution, and results of systematic reviews of randomized controlled trials (RCTs). The SysBank data model has been adapted from RCT Bank, a knowledge base of randomized trials, and refined using three published systematic reviews. SysBank links directly to the RCT Bank entries of studies included in the systematic review. SysBank builds upon RCT Bank to support computer-assisted evidence-based medicine.

Artificial Intelligence↗

PubMedDate not supplied

Initiating a novel therapy in preventing postpartum hemorrhage in rural India: a joint collaboration between the United States and India.

BACKGROUND: Maternal mortality rates in India are estimated at 560/100,000 live births and postpartum hemorrhage (PPH) accounts for 35-56% of these deaths. Given that 50% of births in rural India occur at home, oral Misoprostol administered by minimally trained midwives may be an effective uterotonic agent for preventing PPH when the use of other uterotonics is not feasible. While the import for testing the effectiveness of this intervention may be readily obvious, the elements essential for the conduct of a scientific study in rural areas served by indigenous health workers may not be as evident. METHODS: We present the design as well as the preparation and development of an ongoing NICHD sponsored U.S.-Indian collaborative randomized, placebo-controlled, clinical trial (RCT) conducted in four Primary Health Center areas of Belgaum District, Karnataka, India. The primary goal of the trial is to assess the effectiveness of Misoprostol 600 microg orally in reducing the incidence of acute PPH (> or = 500 mL) in women delivering at home or in neighboring sub-centers. 1600 pregnant women will be randomized to receive Misoprostol or placebo immediately post-delivery of the infant. However, beyond testing the scientific merit of the RCT, this study also tests the feasibility of having indigenous midwives regularly using Misoprostol in rural areas as well as the willingness of these communities to accept this intervention. In addition, this paper also explores the international and community collaborations necessary for the conduct of this study. FINDINGS: It is necessary to have several critical elements in place, including international collaboration between the Indian and US research sites, funding through a private/public collaboration and trained scientists, as well as commitment from the community for the successful conduct of such a study. In the development and implementation of a RCT, careful attention must be paid to the training of field personnel involved in the delivery process and developing a data collection and monitoring system to ensure that information gathered is valid. CONCLUSIONS: A joint U.S.-Indian collaboration to test the efficacy and the feasibility of an innovative method to reduce PPH can serve as collaborative model to develop additional interventions to improve maternal mortality and morbidity. If Misoprostol is shown to be sufficiently safe and efficacious in the prevention of PPH, the appropriate government agencies will be encouraged to make the drug available to midwives (ANMs) and rurally located physicians for whom parenteral medications are either not permitted or impractical and/or unavailable. Such a project can serve as a model applicable to rural settings throughout the developing world for improving delivery practices and reducing maternal mortality and morbidity. These are important public health concerns in India and other developing nations.

Feasibility Studies↗

PubMed2005

Expanding the definition of clinical differences: from minimally clinically important differences to really important differences. Analyses in 8931 patients with rheumatoid arthritis.

OBJECTIVE: Minimally clinically important differences (MCID) have become an important way to interpret data of randomized clinical trials (RCT), but do not reflect the degree of improvement consistent with a "really important difference" (RID). To define RID, we compared mean and/or least desirable clinical states with best and/or most desirable states. METHODS: In total, 8931 patients with rheumatoid arthritis (RA) < 65 years of age completed the Health Assessment Questionnaire (HAQ) and Medical Outcomes Survey Short Form 36 Physical Component Score (PCS). Definitions of RID were based on values for HAQ and PCS corresponding with the best and worst category of the following conditions: disabled vs not disabled: joint replacement vs no joint replacement; < poverty level vs > poverty level; very satisfied with health vs not; and independent in participation activities vs not. RESULTS: In contrast to published MCID values for the HAQ of approximately 0.22, RID was as high as 0.76 using objective reference conditions and 0.87 using the subjective measure of dependence vs independence. The HAQ score of independent RA patients was 0.38 (SD 0.45), and was 0.42 (SD 0.53) for those very satisfied with their health. The difference in HAQ scores between disabled and working patients was approximately 0.75. PCS differences were similarly increased. CONCLUSION: RID values are 3 to 4 times greater than MCID values. Although MCID are meaningful statistics for RCT, the RID percentage achieved [(actual improvement/RID) 100%] is a simple way to put the results of RCT in a broader perspective that gives an idea of how much additional treatment effect is needed.

Arthritis, Rheumatoid↗

PubMed1992

Different risks in two familial translocations t(9;12) with similar breakpoints.

The risk of offspring with unbalanced karyotypes born to carriers of reciprocal chromosomal translocation (RCT) is important to evaluate for further family planning and prenatal diagnosis. The authors describe two families with carriers of similar RCT concerning breakpoint positions and discuss the different individual risks for abnormal progeny. These translocations were studied by GTG, RBG and CBG banding. They have the same breakpoint on 9p, i.e. 9p22, and a different one on 12p, i.e. terminal (pter----p13) and intermediate (p11.2), respectively. The risk value of 27% for family 1 was obtained directly from the large enough pedigree (high risk) a risk value of about 5% was estimated for family 2, according to the guidelines of Stene and Stengel-Rutkowski (1988). The data show that similar translocations with only slight differences in the breakpoints position have different risks for unbalanced progeny. Results of these empiric findings may be used directly in genetic counselling of a family with RCT leading to a single imbalance of the same segment.

Adolescent↗

PubMed2006

[The role of neurovisualization methods in diagnosis and verification of vertigo etiology].

Roentgen computed tomography (RCT) and MR-imaging (MRI) were used in investigation of vertigo etiology and affection of the cochleovestibular analyzer in 130 patients aged 28 to 74 years with recurrent systemic rotatory vertigo or its other symptoms. All the patients have undergone comprehensive otoneurological examination, RCT and MRI which showed that peripheral cochleovestibular syndromes (PCVS) caused by arterial hypertension (AH), atherosclerosis (AS), vascular dystonia (VD) are rarely characterized by focal alterations in the brain. PCVS comparison with blood flow in the vertebral arteries (VA) detected most frequently anomalies and asymmetries of the diameters. MR-angiography plays an important role in verification of pathology of intracranial VA. In central cochleovestibular syndrome (CCVS) with AH, AS, VD, principal pathological changes were registered in the brain trunk and cerebellum by MRI. Vestibulometry and otoneurological method detect not only vascular cochleovestibular peripheral and central syndromes but also to make differential diagnosis. RCT and MRI verify cochleovestibular syndromes in patients with multiple encephalomyelitis, VIII nerve neurinoma and tumors of the posterior cranial fossa.

Adult↗

PubMed2005

Hypothermia improves outcome from traumatic brain injury.

Hypothermia for patients with severe traumatic brain injury (TBI) remains controversial despite a strong biological rationale and reasonable evidence from the literature. The "negative" Clifton study seems to have reduced enthusiasm for hypothermia, however the aim of this review is to analyse the evidence from all randomised controlled trials (RCT) and meta-analyses on this topic to determine whether there is adequate support for the view that hypothermia does improve outcome from TBI. The biological rationale for hypothermia is supported by animal and human mechanistic studies of TBI and human clinical studies of brain injury caused by out-of-hospital cardiac arrest. Several small single-centre RCT's have demonstrated that hypothermia leads to both improved survival and improved favourable neurological outcome in TBI. The Clifton study, which was larger and multi-centre, found hypothermia had no major benefits in TBI, although this study can be criticised for several issues of trial methodology (trial design and application of the intervention) and group comparison. Several meta-analyses have given slightly discordant results, but the two most recent meta-analyses agree that hypothermia improves favourable neurological outcome and probably survival. Subsequent to these meta-analyses, a RCT was published which has confirmed that hypothermia is beneficial in a large group of TBI patients. When the published evidence is considered in total, even if hypothermia can't be justified in all TBI patients, if it is applied optimally in the most appropriate patients, hypothermia certainly improves outcome from TBI. If hypothermia is correctly applied (early, long and cool enough) in the optimal group of TBI patients (young with elevated ICP), there seems to be no doubt that hypothermia is effective in improving both survival and favourable neurological outcome from TBI.

Journal Article↗

PubMed2006

How to identify randomized controlled trials in MEDLINE: ten years on.

OBJECTIVE: The researchers sought to assess whether the widely used 1994 Cochrane Highly Sensitive Search Strategy (HSSS) for randomized controlled trials (RCTs) in MEDLINE could be improved in terms of sensitivity, precision, or parsimony. METHODS: A gold standard of 1,347 RCT records and a comparison group of 2,400 non-trials were randomly selected from MEDLINE. Terms occurring in at least 1% of RCT records were identified. Fifty percent of the RCT and comparison group records were randomly selected, and the ability of the terms to discriminate RCTs from non-trial records was determined using logistic regression. The best performing combinations of terms were tested on the remaining records and in MEDLINE. RESULTS: The best discriminating term was "Clinical Trial" (Publication Type). In years where the Cochrane assessment of MEDLINE records had taken place, the strategies identified few additional unindexed records of trials. In years where Cochrane assessment has yet to take place, "Randomized Controlled Trial" (Publication Type) proved highly sensitive and precise. Adding six more search terms identified further, unindexed trials at reasonable levels of precision and with sensitivity almost equal to the Cochrane HSSS. CONCLUSIONS: Most reports of RCTs in MEDLINE can now be identified easily using "Randomized Controlled Trial" (Publication Type). More sensitive searches can be achieved by a brief strategy, the Centre for Reviews and Dissemination/Cochrane Highly Sensitive Search Strategy (2005 revision).

Abstracting and Indexing↗