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PubMed1992

Creation of a semiannual report for a multicentre co-operative clinical trials group.

The Southwest Oncology Group (SWOG) is a multicentre co-operative group that performs prospective clinical trials in cancer. The SWOG Statistical Center is responsible for preparing a report of studies for the semiannual meetings. The report includes a summary of study design and eligibility criteria, current accrual, baseline patient characteristics, toxicity, and, for studies closed to accrual and with sufficiently mature outcome data, tumour response or patient survival. A software program, Statisticians' Report Worksheet (SRW), has been developed by the programming staff at the SWOG Statistical Center. This program enables each disease specific chapter to be created independently, but ensures that tables and graphs for all chapters are of uniform style. We describe here the coordination of the report, and the use of the SRW program. This reporting system can serve as a model for other groups.

Clinical Trials as Topic↗
PubMed1993

Evaluation of multicentre clinical trial data using adaptations of the Mosteller-Tukey procedure.

Two procedures, based on proposals discussed by Mosteller and Tukey, are described for obtaining a combined estimate of the difference between two treatment means and its confidence interval from multicentre clinical trial data. Both procedures provide estimates in the possible presence of heteroscedasticity. The first procedure is designated the primary analysis for efficacy assessment. It omits treatment-by-centre interaction from the error term for treatment, unless there is substantial evidence of qualitative interaction (Ciminera et al.) or other special circumstances. The second procedure is the primary analysis whenever there is substantial evidence of qualitative interaction, and can be used whenever there are other reasons to make an analysis allowing for interaction.

Asthma↗
PubMedDate not supplied

Publications from multicentre clinical trials: statistical techniques and accessibility to the reader.

Articles from multicentre randomized clinical trials were analysed by methods adapted from Emerson and Colditz and Juzych et al. to compare the frequency with which different statistical methods are used by clinical trials investigators with the frequency used by other researchers, and to determine how much statistical knowledge is required to interpret the statistical treatment of data from clinical trials. We observed differences between the frequency of usage of statistical methods and the accessibility of the clinical trials publications and those of all medical research articles published by specific journals. Clinical trials publications are less accessible than others in medical journals to the reader who knows only descriptive statistics, t-tests, contingency tables, power calculations, and life table methods. Many more statistical methods must be known by a reader to understand fully publications regarding treatment group comparisons for the primary outcomes of interest from clinical trials.

Data Interpretation, Statistical↗
PubMed2026

Acetate- Versus Lactate-Buffered Crystalloids for Prevention of Post-ERCP Pancreatitis in Patients Without Access to Rectal NSAIDs: A Multicentre Double-Blind Randomized Trial.

BACKGROUND: Aggressive peri-procedural intravenous fluid (IVF) therapy with lactated Ringer's solution (LR) reduces the risk of post-ERCP pancreatitis (PEP), but the standard 8-h protocol is impractical in outpatient settings and the optimal fluid type remains uncertain. We compared LR with an acetate-buffered balanced crystalloid (AC) using a symptom-guided 4-h aggressive IVF protocol. METHODS: This multicentre, double-blind, randomized superiority trial was conducted at three academic hospitals in Korea where rectal NSAIDs are unavailable. Adults with native papillae and moderate-to-high PEP risk were randomized to receive LR or AC. The IVF protocol comprised 10 mL/kg boluses before and after ERCP, followed by 3 mL/kg/h for 4 hours and extended to 8 hours if abdominal pain developed or worsened. The primary outcome was PEP incidence; secondary outcomes included early post-ERCP pain and adverse events. RESULTS: Of 813 patients (404 LR, 409 AC), PEP occurred in 12.4% of the LR group and 11.5% of the AC group (relative risk [RR] 0.93; 95% CI, 0.64-1.35; P = 0.70). Rates of mild (7.9% vs. 7.1%) and moderate (4.5% vs. 4.4%) PEP were similar, and no severe PEP or fluid overload occurred. Among the 68.3% of patients who remained asymptomatic at 4 hours and required only 4-h IVF, PEP occurred in 7.4%, with no cases of severe PEP. CONCLUSION: In this superiority trial, acetate-buffered crystalloid did not reduce PEP compared with lactated Ringer's solution, and no significant safety differences were observed between the two agents. Lactated Ringer's remains the recommended first-line crystalloid for aggressive hydration when rectal NSAIDs are unavailable. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05832047).

Humans↗
PubMed1996

Multicentric epithelioid angiosarcoma of the bone. Pitfalls in clinical and morphological diagnosis.

Epithelioid angiosarcoma of the bone represents a challenging diagnosis by bone marrow biopsy. We present a case of a multicentric high grade angiosarcoma of the bone with epithelioid features. On the basis of the clinical presentation, the radiological findings, and the appearance of loosely clustered tumor cells detected in the initial bone marrow biopsy, the main differential diagnoses considered were a poorly differentiated non-secretory multiple myeloma and metastatic carcinoma. Subsequent morphologic, immunohistochemical and electron microscopic examination of tissue samples clarified the nature of the tumor as epithelioid angiosarcoma. We discuss potential pitfalls in clinical and morphological diagnosis. The strong reactivity of the tumor cells with the nonspecific but ubiquitous mesenchymal marker vimentin in similar cases should direct early attention to the rare malignant bone tumor, epithelioid angiosarcoma, with subsequent confirmation of this diagnosis with specific immunohistochemical endothelial cell markers and/or electron microscopy.

Aged↗
PubMed1995

Serum half-life of CA 125 during early chemotherapy as an independent prognostic variable for patients with advanced epithelial ovarian cancer: results of a multicentric Italian study.

This retrospective multicentric study assessed the prognostic value of the serum CA 125 assay and the common clinicopathological variables in 225 patients with advanced epithelial ovarian cancer. All of these patients had serum CA 125 > or = 35 U/ml before the first cycle of chemotherapy and had had serial antigen determinations during early chemotherapy. By univariate analysis pathological complete response rate was significantly related to stage, size of residual disease after first surgery, serum CA 125 before the first cycle and before the third cycle of chemotherapy, and serum CA 125 half-life. Multiple logistic regression showed that residual disease (P = 0.002), serum CA 125 half-life (P = 0.004), serum CA 125 before the third cycle (P = 0.004), and serum CA 125 before the first cycle (P = 0.03) retained a significant value in predicting second-look findings. By log-rank test survival was significantly related to stage, residual disease, tumor grade, serum CA 125 before the third cycle, and serum CA 125 half-life. Cox proportional hazard model showed that residual disease (P = 0.0001), serum CA 125 half-life (P = 0.007), and tumor grade (P = 0.01) retained a significant value in predicting survival. In conclusion, serum CA 125 half-life during early chemotherapy was an independent prognostic factor for both the achievement of a pathological complete response and the survival of patients with advanced epithelial ovarian cancer.

Adult↗
PubMed2000

Expression and localization of human herpesvirus 8-encoded proteins in primary effusion lymphoma, Kaposi's sarcoma, and multicentric Castleman's disease.

To investigate the expression of human herpesvirus 8 (HHV8)-encoded proteins in the cells of primary effusion lymphoma (PEL), Kaposi's sarcoma (KS) and multicentric Castleman's disease (MCD), nine rabbit polyclonal antibodies to K2, ORF26, K8, K8.1, K10, K11, ORF59, ORF65, and ORF73 were developed. Western blot analysis in PEL cell lines (TY-1 and BCBL-1) revealed that the expression of these proteins, except ORF73 (LANA), was induced by tetradecanoylphorbol acetate (TPA) treatment, indicating that these proteins are lytic proteins. Immunofluorescence assay in primary PEL cells derived from pericardial effusion and PEL cell lines with and without TPA treatment revealed that primary PEL cells exhibited the same expression pattern as noninduced PEL cell lines, and the treatment changed localization of K8, ORF59, and ORF65 proteins. Immunohistochemistry revealed that 90% of KS spindle cells expressed the ORF73 protein, whereas a small population of KS cells expressed K8, K10, K11, ORF59, and ORF65 proteins. In MCD, ORF73, ORF59, K8, K2, and K10 proteins were expressed in the cells at mantle zone of the follicle. These data indicate that KS and PEL cells expressed predominantly latent proteins, whereas MCD expressed both latent and lytic proteins, suggesting that HHV8 plays a different role in the pathogenesis of HHV8-associated diseases.

Animals↗
PubMed2007

The use of antiviral drugs in the prevention and treatment of Kaposi sarcoma, multicentric Castleman disease and primary effusion lymphoma.

Kaposi sarcoma-associated herpesvirus [KSHV, also known as human herpesvirus 8 (HHV-8)] is the most recently identified member of the human herpesvirus family. Kaposi sarcoma (KS), primary effusion lymphoma, and multicentric Castleman disease are all associated with KSHV infection. Although the incidence of KS has declined dramatically in areas with access to highly active antiretroviral therapy, it remains the most common AIDS-associated malignancy in the developed world and is one of the most common cancers in developing nations. Current treatment options for KSHV-associated disease are ineffective, unavailable, or toxic to many affected persons. A growing body of basic science, preclinical, and observational data suggests that antiviral medications may play an important role in the prevention and treatment of KSHV-associated disease.

Animals↗
PubMed1992

Multicentre trial of ABO-incompatible kidney transplantation. Japanese Biosynsorb ABO-incompatible kidney transplant study group.

A multicentre study of ABO incompatible kidney transplantation using Biosynsorb was started in Japan in November 1989. A total of 51 cases were registered comprising 23 cases of A incompatibility, 26 cases of B incompatibility and two cases of AB incompatibility. The removal of antibodies (IgG and IgM) was carried out using Biosynsorb in 16 cases, plasmapheresis in four cases and use of both combined in 31 cases. The treatment using Biosynsorb was repeated 3.4 times on average. Serum titres of anti-A (IgG and IgM) antibodies decreased to 4.9 +/- 5.0 and 2.7 +/- 1.7 and for anti-B titres decreased to 2.8 +/- 3.5 and 2.4 +/- 3.2. Rejection was found in 33 cases: hyperacute one, accelerated acute five, and acute 27. In two cases rejection was developed concomitantly with a steep elevation in antibody titres. Three patients died, two with functioning grafts. Eight grafts were lost. Patient and graft survivals at 2 years were 94.1% and 84.3%, respectively. From these results it is concluded that: 1. Biosynsorb and plasmapheresis are effective in removing anti-A and anti-B antibodies; 2. graft and patient survivals are similar to those in ABO compatible cases; 3. anti-A and anti-B titres less than 16 are recommended at the time of transplantation; 4. anti-A and anti-B titres higher than 128 may be considered as a risk factor for rejection in the early stages after transplantation.

ABO Blood-Group System↗
PubMed1978

Outline of a prospective multicentric study on the clinical significance of the Kiel classification of non-Hodgkin's lymphomas.

Retrospective analysis of 405 patients suggested the clinical relevance of the Kiel classification of non-Hodgkin's lymphomas. In order to further clarify the clinical and prognostic features of the lymphoma entities diagnosed according to this histopathologic scheme, a prospective multicentric study was initiated by the Kiel Lymphoma Group. Initial staging evaluation is performed according to the Ann Arbor classification. On the basis of the hypothesis that like Hodgkin's disease non-Hodgkin's lymphomas originate, at least in part, as localized nodal or extranodal tumors, extended field irradiation is performed in localized disease (stages I and II) (with the exception of lymphoblastic lymphoma in children and young adults) whereas in more widespread disease (stages III and IV) (with the exception of stage III of centroblastic-centrocytic lymphoma) chemotherapy with additional radiotherapy is applied.

Adult↗
PubMed1996

Two-year data from the European multicentre tacrolimus (FK506) liver study.

To provide a more definitive assessment of the efficacy and safety of tacrolimus therapy in comparison with cyclosporin, the extended follow-up of the European multicentre study is reported. Two-year Kaplan-Meier estimates indicated significant reductions in acute (tacrolimus 45.4%, cyclosporin 55.8%; P = 0.006), refractory (1.2% versus 6.4%; P = 0.003) and chronic rejection (2.0% versus 6.9%; P = 0.015) despite significantly lower steroid usage in patients receiving tacrolimus therapy. Patient and graft survival rates (80.6% versus 74.8% and 74.5% versus 70.0%, respectively) were also superior, although these failed to reach statistical significance. Safety profiles were comparable for most major categories (including renal, neurological and glucose metabolic disorders) and in certain aspects were more favourable for tacrolimus. Hypertension (28.0% versus 39.6%, P < 0.01) and cytomegalovirus infection (14.8% versus 22.3%, P < 0.01), two events with important long-term clinical consequences, were reported significantly less frequently. Hirsutism (0.0% versus 8.7%, P < 0.01) and gum hyperplasia (0.0% versus 2.3%, P < 0.05) were absent in patients receiving tacrolimus. Tacrolimus appears to provide effective and safe long-term immunosuppression.

Adolescent↗
PubMed1996

UK multicentre study to assess the safety and tolerability of Neoral in stable renal transplant patients. UK Neoral Study Group.

The safety and tolerability of transferring maintained renal transplant patients from Sandimmun to Neoral is being assessed in a multicentre, open-label, single-arm study. A total of 250 patients has been enrolled and results are available from 75 patients up to 12 months post-transfer. A slight trend to higher mean cyclosporin trough levels was seen in this cohort, but trough levels were unchanged in the sub-group receiving > or = 1 dose changes. The mean dose fell by 13%. Creatinine levels showed a slight overall upward trend. Blood pressure and uric acid were unchanged and adverse events were typical of those seen with Sandimmun. Neoral was well-tolerated. Data from the full cohort of 250 patients up to 3 months post-transfer support these findings. These results indicate that transfer from Sandimmun to Neoral is safe and well-tolerated and provides appropriate immunosuppression at a lower average dose than Sandimmun. The Neoral dose should be adjusted promptly, as required, to maintain the target trough level.

Adolescent↗
PubMed1998

Sustained efficacy and safety of idebenone in the treatment of Alzheimer's disease: update on a 2-year double-blind multicentre study.

The 2-year efficacy and safety of idebenone were studied in a prospective, randomized, double-blind multicentre study in 3 parallel groups of patients with dementia of the Alzheimer type (DAT) of mild to moderate degree. A total of 450 patients were randomized to either placebo for 12 months, followed by idebenone 90 mg tid for another 12 months (n = 153) or idebenone 90 mg tid for 24 months (n = 148) or 120 mg tid for 24 months (n = 149). The primary outcome measure was the total score of the Alzheimer's Disease Assessment Scale (ADAS-Total) at month 6. Secondary outcome measures were the ADAS cognitive (ADAS-Cog) and noncognitive score (ADAS-Noncog), the clinical global response (CGI-Improvement), the SKT neuropsychological test battery, and the Nurses' Observation Scale for Geriatric Patients (NOSGER-Total and IADL subscale). Safety parameters were adverse events, vital signs, ECG and clinical laboratory parameters. During the placebo controlled period (the first year of treatment), idebenone showed statistically significant dose-dependent improvement in the primary efficacy variable ADAS-Total and in all the secondary efficacy variables. There was no evidence for a loss of efficacy during the second year of treatment, as a further improvement of most efficacy variables was found in the second year in comparison to the results at the 12 months visit. Also, a clear dose effect relationship (placebo/90 mg < idebenone 90 mg < idebenone 120 mg) was maintained throughout the second year of treatment. This suggests that idebenone exerts its beneficial therapeutic effects on the course of the disease by slowing down its progression. Safety and tolerability of idebenone were good and similar to placebo during the first year of treatment and did not change during the second year.

Adult↗
PubMed1985

Maternal epilepsy and birth defects: a case-control study in the Italian Multicentric Registry of Birth Defects (IPIMC).

A case control study on the association between maternal epilepsy, anticonvulsants use during pregnancy and birth defects was carried out in the Italian Multicentric Registry of Birth Defects (IPIMC). In the period 1980-1983, 7,607 malformed babies out of 439,717 total births (still + live) were registered. Fourty-one malformed babies with maternal epilepsy were identified (5.39 X 1,000). The overall relative risk of having a malformed baby among pregnant epileptic women was 1.87. Spina Bifida, Congenital Heart Defects, Clefts, Diaphragmatic Hernia and Trisomy 18 were more frequent than expected among babies with maternal epilepsy. The different therapeutic regimens were also tested to identify the possible independent teratogenic effect of anticonvulsants. A statistically significant association between Spina Bifida and Valproic Acid (odds ratio 22.7; Fisher p value = 0.0364) was observed: no other anticonvulsant tested showed any association with any type of malformation.

Abnormalities, Drug-Induced↗
PubMed1993

Determination of the technetium-99m mercaptoacetyltriglycine plasma clearance in children by means of a single blood sample: a multicentre study. The Paediatric Task Group of the EANM.

A multicentre European study was undertaken in order to determine a reasonable algorithm allowing the determination of overall technetium-99m mercaptoacetyltriglycine clearance using a single blood sample. Employing multiple blood sample clearance as a reference method, it was shown that an acceptable estimation of the MAG3 renal clearance could be obtained using a blood sample taken at any time between 30 and 40 min after tracer injection. After correction for body surface area, comparison of clearance determined using (a) the single blood sample and (b) the multiple blood samples provided a coefficient of correlation of 0.949 and an SEE of 27 ml/min. This algorithm is valid for clearance values higher than 100 ml/min/1.73 m2 and for children older than 1 year of age.

Algorithms↗
PubMed1995

Czech and Slovak spirapril intervention study (CASSIS). A randomized, placebo and active-controlled, double-blind multicentre trial in patients with congestive heart failure.

A randomized, double-blind, placebo- and active-controlled multicentre study with spirapril, a new angiotensin-converting enzyme inhibitor (ACEI), has been conducted in patients with chronic congestive heart failure (CHF) of NYHA classes II-IV. After a placebo run-in period of 1-4 weeks, patients were randomly assigned to one of five treatment groups: placebo (n = 48), spirapril 1.5 mg (n = 48), spirapril 3 mg (n = 53), spirapril 6 mg (n = 51) or enalapril 5/10 mg (n = 48). The primary objective was to assess changes in exercise tolerance, and the secondary objective was an assessment of cardiovascular signs and symptoms, quality of life, ejection fraction and chest X-ray findings. Exercise tolerance increased in all groups; however, no statistically significant differences were found between any of the groups. There was a statistically significant reduction of mortality in the pooled spirapril groups compared with placebo, and a trend for reduction of serious cardiovascular adverse events as well as duration of hospitalization. These effects and improvements in lung congestion appeared to be dose dependent. In patients with moderate to severe heart failure, the combination with first-generation calcium channel blockers had an unfavourable effect on exercise capacity and clinical parameters. Spirapril might be an effective alternative to enalapril in the treatment of patients with CHF. The role of the exercise tolerance test in establishing efficacy of ACEIs in CHF and the widespread use of nifedipine in CHF is questioned.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1982

Kelfiprim, a new sulpha-trimethoprim combination, versus cotrimoxazole, in the treatment of urinary tract infections: a multicentre, double-blind trial.

A new combination of trimethoprim with a sulphonamide, named Kelfiprim, differs from cotrimoxazole in that: a) the sulpha drug is sulphamethopyrazine instead of sulphamethoxazole; b) the trimethoprim to sulpha ratio is 5:4 instead of 1:5; c) the presence of a long-acting sulphonamide allows the administration of a daily dose of one capsule, following an initial loading dose of two capsules; d) a reduced amount of trimethoprim is given, as compared to cotrimoxazole, without any decrease of efficacy. Kelfiprim [KP] was compared to cotrimoxazole [Co] in a multicentre double blind trial. Sixty four patients suffering from acute and chronic infections of the upper and lower urinary tract entered the study. Urine sterilisation and clinical improvement without relapses showed no differences from the two treatment groups. Tolerance was excellent except in two patients, one treated with KP and the other treated with Co, who showed a transient exanthema.

Clinical Trials as Topic↗
PubMed1989

Description of various types of intensive and intermediate care units in France. French Multicentric Group of ICU Research.

The types of intensive care are multiple. The aim of this multicentric study was to describe activity of different ICUs using the same methods. 38 ICU were chosen by cooption, not randomization. Collected data concerned input (age, previous health status (HS), Simplified Acute Physiology Score or SAPS, Intensive Care Group (ICG), processes (TISS points), percentage of ventilated patients and pulmonary arterial lines and outcome (ICU death rate). The 3 ICG were: M = medical: all the none surgical patients; S = surgical patients operated in emergency setting during the week preceding or following ICU admission; E = surgical patients whose admission to ICU was scheduled at least 24 h before because of elective surgery. 3,687 patients were studied, classified as follows: M = 2175; S = 885; E = 627. The first part of the results concerned the differences between the three ICG: inputs, processes and outcome were very different in the three groups M, S, E, particularly in the E (elective) group, where therapeutic level was higher for low SAPS and mortality lower for high SAPS. The second part of the results concerns the differences between the ICUs. Intermediate units had older, less severe, and mainly medical patients. Surgical patients had better previous health status, were younger and scheduled for 40%. TISS points were higher, mainly by a higher rate of ventilated patients and patients with pulmonary artery lines on the first day. Specialized units characteristics depended mainly on the ICG.(ABSTRACT TRUNCATED AT 250 WORDS)

Diagnosis-Related Groups↗