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At least 307 records · Page 17Linked to original sources
PubMed1998

Is there a methimazole dose effect on remission rate in Graves' disease? Results from a long-term prospective study. The European Multicentre Trial Group of the Treatment of Hyperthyroidism with Antithyroid Drugs.

OBJECTIVE: The optimal antithyroid drug regimen for Graves' disease remains a matter of controversy. The European Multicentre Trial Group has investigated the effects of methimazole drug dose on the long-term outcome of Graves' disease. DESIGN: Extended follow-up of patients from a prospective multicentre trial, designed to study methimazole dose effects on the outcome of Graves' disease. We have reported previously that the relapse rates did not differ after a medication-free observation period of 12 months; the relapse rates were 37% and 38%, respectively. In this paper, we describe the outcome in these patients after a mean observation period of 4.3 +/- 1.3 years and have looked for potential predictors of this outcome. PATIENTS: Three hundred and thirteen patients with Graves' disease were randomized to treatment with a constant dose of 10 or 40 mg of methimazole for 1 year, with levothyroxine supplementation as required. MEASUREMENTS: At the time of inclusion into the trial: thyroid size, T4, T3, TSH-binding inhibiting immunoglobulins, urinary iodide excretion, thyroid uptake, Crook's therapeutic index of hyperthyroidism (a measure of clinical disease severity). At the time of follow-up examination: TSH, T4, T3, thyroid size, thyroid ultrasound, THS-binding inhibiting immunoglobulins. RESULTS: The overall relapse rate was 58%. There was no difference in relapse rates between patients treated with either 10 or 40 mg of methimazole (58.3 vs. 57.8%). Five patients had become spontaneously hypothyroid, without obvious relationship to antithyroid drug dose. Patients who relapsed and patients who remained in remission did not differ with respect to: age, goitre size, ophthalmopathy, median iodine excretion, serum T4 or serum T3, Crook's therapeutic index and thyroid uptake at the time of study entry. Thus, none of these variables was potentially suitable for predicting outcome. This finding was confirmed by Cox's proportional hazard regression. Thyroid volume, measured by ultrasound, did not differ between patients in remission and patients with relapse. There was no difference in the course of endocrine eye signs, in the requirement for steroid and radiotherapy for eye signs, or in thyroid echostructure between patients in the 10 and in the 40 mg group, nor was serum TSH different in patients who had remained in remission (0.8 +/- 0.6 mU/l in the 10 mg group, 1.0 +/- 0.8 mU/l in the 40 mg group). CONCLUSIONS: The dose of methimazole in Graves' disease therapy can safely be kept to the minimal required dose. This will provide the same chance of remission as higher doses, and provide the best balance of risk and benefit.

Adult↗
PubMed2002

Extra-abdominal desmoid fibromatosis: two familial cases with synchronous and metachronous multicentric hyalinizing nodules.

AIMS: Extra-abdominal desmoid fibromatosis is an uncommon tumour. We present here two exceptional familial cases of extra-abdominal desmoid fibromatosis, one of which was synchronous and metachronous. METHODS AND RESULTS: The first patient was a 37-year-old woman who had noted a tumour growing on the dorsum of her right foot when she was 12 years old. She underwent excision of the tumour but in the following year the tumour recurred locally and grew into multiple nodules. Subsequently, multicentric tumours appeared in her knee, distal and posterior aspects of her thigh, right back and right anterior shoulder. Polyostotic fibrous dysplasia of the femur and cranium was found on radiological examination. The second patient was a 74-year-old man, the uncle of the first patient. He underwent an excisional operation of a tumour on the internal malleolus surface of his fibula when he was 46 years old. The tumour recurred 7 years later and was excised. His post-operative course has been uneventful. The histology of the primary and recurrent tumours was distinctive and consistently showed hyalinizing scar-like features. CONCLUSIONS: Familial cases of extra-abdominal desmoid fibromatosis with extensive multicentric lesions and distinctive hyalinizing scar-like features are described. Recently, attenuated familial adenomatous polyposis with familial desmoid fibromatosis has been recognized, and familial desmoid fibromatosis without adenomatous polyposis may also be one of its variants. Although the present cases have no history of colon polyposis or carcinoma, monitoring of the intestinal tract would seem to be indicated.

Adult↗
PubMed2000

An internet-based learning portfolio in resident education: the KOALA multicentre programme.

CONTEXT AND OBJECTIVES: To describe the Computerized Obstetrics and Gynecology Automated Learning Anaalysis (KOALAtrade mark), a multicentre, Internet-based learning portfolio and to determine its effects on residents' perception of their self-directed learning abilities. METHODS: The KOALA programme allows residents to record their obstetrical, surgical, ultrasound, and ambulatory patient encounters and to document critical incidents of learning or elements of surprise that arose during these encounters. By prompting the student to reflect on these learning experiences, KOALA encourages residents to articulate questions which can be directly pursued through hypertext links to evidence-based literature. Four Canadian residency training programmes participated in the pilot project, from February to May 1997, using a dynamic relational database with a central server. All participants completed the Self-directed Learning Readiness Scale and a learning habits questionnaire. The impact of the KOALA programme on residents' perception of their self-directed learning abilities was measured by comparing KOALA-naive schools (schools 2, 3, and 4) with school 1 (exposed to the KOALA prototype for 1 year). Ordered variables were compared using the Mann-Whitney U test and continuous variables with the Student t test (statistical significance P < 0. 05). RESULTS: During the study period, 7049 patient and 1460 critical incidents of learning were recorded by 41 residents in the four participating universities. Residents at the exposed school (school 1) had a significantly higher perception of their self-directed learning (P < 0.05) and believed their future learning was less likely to be from continuing medical education (P < 0.028), textbooks (P < 0.04), and didactic lectures (P < 0.011) and would be derived from a learning portfolio with online resources. CONCLUSION: This Internet-based, multi-user, multicentre learning portfolio has a significant effect on residents' perception of their self-directed learning abilities.

Canada↗
PubMed1998

Methods for economic evaluation alongside a multicentre trial in developing countries: a case study from the WHO Antenatal Care Randomised Controlled Trial.

The WHO is testing a new rationalised programme of antenatal care in a multicentre randomised trial. The motivation for this trial arose from the current uncertainty about the effectiveness of different approaches to provision of routine antenatal care. Decision makers also lack information about the costs of providing routine antenatal care and the cost-effectiveness of one programme over another. Such information will be needed before the final choice of programme can be made. The WHO trial provides an ideal opportunity to estimate and compare the incremental costs and cost-effectiveness of the new programme in four countries (Argentina, Cuba, Saudi Arabia, Thailand). A separate economic component has been organised to measure the costs of antenatal care. Methods for cost identification and measurement, and methods for economic analysis in the context of an international study are based on current recommendations for the conduct of economic evaluations alongside trials. However, several aspects require further development. In particular, this includes defining standard methods for costing in different countries; measuring women's costs of access to care; and making comparisons across international settings. The economic evaluation will also inform similar multicentre international trials and investigate issues of generalisability beyond trial settings.

Argentina↗
PubMed1999

Multicentric reticulohistiocytosis in a child.

A case of multicentric reticulohistiocytosis in an 8-year-old girl, which is a diagnosis rarely seen in children, is presented. Multicentric reticulohistiocytosis is a disorder of unknown aetiology, predominantly affecting the joints, skin and mucosa. Joint symptoms, but not cutaneous lesions, have improved with treatment with methotrexate.

Arthritis, Juvenile↗
PubMed2001

Multicentric telangiectatic osteosarcoma.

A rare case of multicentric telangiectatic osteosarcoma in a 29-year-old woman is described. A plain X-ray showed a pure osteolytic lesion of the navicular, cuboid and I, II, III cuneiform bones. On magnetic resonance images, a T1-weighted image showed heterogeneous low signal intensity. A T2-weighted image showed heterogeneous high signal change with multicentric cystic foci and fluid-fluid levels. Histologically, the lesion showed typical telangiectatic osteosarcoma with numerous atypical giant cells.

Adult↗
PubMed2001

Improving patient recruitment to multicentre clinical trials: the case for employing a data manager in a district general hospital-based oncology centre.

One of the most frequently cited reasons for poor recruitment to multicentre randomized clinical trials is the additional workload placed on clinical staff. We report the effect on patient recruitment of employing a data manager to support clinical staff in an English district general hospital (DGH). In addition, we explore the effect data managers have on the quality of data collected, proxied by the number of queries arising with the trial organizers. We estimate that the cost of employing a data manager on a full-time basis is 502 per patient recruited but may amount to 326 if the appointment is part-time. Data quality is high when full responsibility lies with a data manager but falls when responsibility is shared. Whether the costs of employing a data manager to recruit patients from a DGH are worth incurring depends on the value placed on the speed at which multicentre trials can be completed, how important it is to broaden the research base beyond the traditional setting of teaching hospitals, and the amount of evaluative data required.

Clinical Trials as Topic↗
PubMed1999

Organ-preserving surgery for multicentric carcinoma of the pancreas.

Multicentric ductal carcinoma of the pancreas is usually treated by total pancreatectomy if surgically resectable. We present a case of metachrone, multicentric ductal carcinoma of the pancreas which was treated using an organ-preserving method. The reasons for doing so and the oncological and functional outcomes are discussed.

Adenocarcinoma↗
PubMed1999

Realistic expectations for patients with stent-graft treatment of abdominal aortic aneurysms. Results of a European multicentre registry.

OBJECTIVE: the outcomes for patients after endovascular treatment of abdominal aortic aneurysm (AAA) are determined primarily by the endpoints of death and endoleaks, the latter representing continued risk of rupture. The data of a multicentre registry were analysed with regard to the early outcome of stent-graft procedures for AAA and the complications associated with this treatment. In addition, the results during follow-up were analysed by determining mortality and endoleak development as separate endpoints and as a combined endpoint defined as endoleak-free survival. SETTING: 38 European institutions of Vascular Surgery collaborating in a multicentre registry project. PATIENTS AND METHODS: 899 patients with AAA underwent between May 1994 and March 1998 elective endovascular repair (818 men and 81 women; mean age 69 years). 80 (8.9%) of the patients had medical conditions that excluded them from open repair. 818 (91%) of patients had a bifurcated device, 63 (7%) had a straight tube graft, and only 18 (2%) had an aorto-uni-iliac device. Clinical examination and contrast-enhanced computed tomography was performed at fixed follow-up intervals to assess increase or decrease of the maximum transverse diameter (MTD). Endoleaks observed at follow-up were discriminated into persistent endoleak and temporary endoleak. The latter is defined as single time observed endoleaks or with two or more negative imaging studies between observed endoleaks. Life-table analyses were used to calculate the rates of freedom-from-endoleak (no endoleak at any time), freedom-from-persistent endoleak (no persistent endoleak), patient survival, and persistent-endoleak-free-survival. RESULTS: the median follow-up of this patient series was 6.2 months. The ratio between observed and expected follow-up data was 82% for the overall follow-up period. However, at 18 months of follow-up this rate was only 45%. The number of patients followed during this period was sufficient to allow statistically meaningful assessment. The MTD in patients with temporary endoleaks demonstrated a significant decrease at 6 to 12 months compared to preoperative values (mean 57 and 53 respectively, p =0.004). In patients with persistent endoleaks there was no change between the preoperative and 6-month MTD (mean 57 and 60 mm respectively). At 6 and 18 months freedom-from-endoleak was 83% and 74% and freedom-from-persistent endoleak was 93% and 90%, respectively. The 18-month cumulative patient survival was 88% and the main outcome measure, the persistent endoleak-free-survival was 79%. CONCLUSIONS: the MTD decreases in patients with temporary endoleak, but not in patients with persistent endoleak. Therefore, the use of the rate of freedom-from-persistent endoleak, reflecting absence of persisting endoleaks to estimate the prognosis with regard to the AAA, is justified. Determining persistent endoleak-free survival appears a rational approach to provide a realistic outlook for patients with stent-grafted AAA. The observed 18-month endoleak-free survival reflects a satisfactory mid-term result.

Aged↗
PubMed2001

Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study.

BACKGROUND: Implantable sensors that monitor haemodynamics over time may be useful in patients with heart failure. This multicentre study assessed the feasibility of a system that has one sensor measuring absolute pressure and another measuring mixed venous oxygen saturation (SvO(2)). Both sensors were mounted on leads that were implanted in the right ventricle. METHODS: Twenty-one patients with heart failure (NYHA II-III) were included. Comparisons were made to right heart catheterizations at implant and at 2, 6 and 12 months thereafter. Patients underwent several haemodynamic provocations during the catheterizations. RESULTS: Overall, among functioning sensors, the IHM-1 values were highly correlated with reference values for all time points during all provocations, demonstrating high reproducibility and stability (r(2)=0.91, 0.79 and 0.78 for systolic, right ventricular diastolic and SvO(2), respectively). Although IHM-1 underestimated reference pressure values by 4.5 mmHg and SvO(2)by 1.6%, this difference was consistent across provocation and stable over 12 months of follow-up. Twelve of the 21 oxygen sensors failed to function and two pressure sensors had component failures. Preliminary analysis of long-term data revealed haemodynamic patterns that may be key indicators for therapeutic interventions. CONCLUSION: This multicentre feasibility study demonstrated the accuracy and stability of sensors implanted in the right ventricle. The IHM-1, using right ventricular pressures and SvO(2), with improved performance, might be useful in the study of pathophysiological mechanisms and treatment interventions in heart failure.

Adult↗
PubMed2000

Pain and quality of life in patients with critical limb ischaemia: results of a randomized controlled multicentre study on the effect of spinal cord stimulation. ESES study group.

We carried out an assessment of pain and quality of life of patients with critical limb ischaemia during the follow-up of a multicentre randomized trial in more detail than previously reported. In a multicentre clinical trial 120 patients were randomized between medical treatment and medical treatment plus spinal cord stimulation. Patients were selected on the basis of clinical symptoms and macrocirculatory data as described in the European consensus document on critical limb ischaemia. Data were collected at intake and then 1, 3, 6, 12 and 18 months later. Primary outcome measures were limb salvage, pain relief and quality of life. Patient and limb survival was estimated with the Kaplan-Meier method. Pain was evaluated using the visual analogue scale (VAS), the McGill pain questionnaire, the pain score of the Nottingham Health Profile (NHP) and the use of analgesics. Quality of life was evaluated using the NHP, the EuroQol and mobility subscore of the Sickness Impact Profile. The 2-year limb survival was 52% for SCS treatment and 46% for standard treatment (p =0.47). Pain relief was considerable in both treatment strategies (p<0.005) with no significant differences between the strategies. The improvement occurred within the first few months and remained stable during further follow-up. Patients with SCS used fewer non-narcotic and narcotic drugs (p<0.001 at t=1 and t=3, p<0.002 at t=6). The overall scores of quality of life improved significantly (p<0.05), with no difference in score between treatments. The subscores of mobility and energy of the NHP in non-amputated patients was significantly better in the SCS group (p<0.005). Amputation had a negative effect on mobility, resulting in a difficult rehabilitation but relieved pain substantially (p<0. 05). In contrast to the existing literature, the randomized trial revealed no major difference in overall pain and quality of life assessment between treatment groups. The effect on energy and mobility was significantly better in patients treated with SCS, who also used substantially fewer analgesics.

Aged↗
PubMed2001

Should a single centre for the assay of biochemical markers of nutritional status be mandatory in multicentric trials?

Clinical trials to identify patients at risk and to assess new therapeutic agents in the nutritional field are often single-site. The principal advantage of mounting a multicentric trial is that patient accrual is much quicker. Albumin, transthyretin, and C-reactive protein are frequently used biochemical markers of nutritional and inflammation status. However, the different techniques, reagents, and calibrators used to measure these markers introduce wide variations in values among laboratories. This study was carried out as part of a prospective multicentric study in chronic respiratory disease patients to evaluate variability and comparability of results among laboratories for these biochemical markers, and to determine whether centralization is necessary. Thirty enrolled laboratories provided their own range of reference values for those proteins a nd were then requested to process two control samples C1 and C2 blind. The results showed a broad dispersion of values for albumin and transthyretin. In 7% of laboratories, results of albumin for C2 (mean, all techniques: 39.1+/-3 g/l) were <35 g/l, the threshold value indicating a potential risk of malnutrition. When only laboratories using immunonephelemetry were considered, the results were satisfactory (CV<10% for all proteins). Given the possible incorrect classification of patients at risk, measurement should be made per site only if all participants use an immunonephelometric method. Otherwise, a centralizing assay of these biological markers should be considered.

Biomarkers↗
PubMed1978

[Multicentric reticulohistiocytosis as a cause of an erosive, destructive arthropathy (author's transl)].

Multicentric reticulohistiocytosis is a special form of an erosive, destructive arthropathy. It can be distinguished from other forms of erosive polyarthropathies by the characteristic x-ray appearances, although the final proof of the diagnosis is histological in association with the clinical features and the presence of nodular skin lesions. A case of multicentric reticulohistiocytosis is described. The typical radiological appearances are discussed and the differential diagnosis from other forms of chronic polyarthritis, such as gout, psoariatic arthropathy, Reiter's disease and erosive osteoarthritis is considered.

Adult↗
PubMed1994

Multicentric angiofollicular lymph-node hyperplasia associated with myasthenia gravis.

Castleman's disease is often referred to as giant lymph-node hyperplasia. Although this localized disorder most commonly involves the mediastinum, recently many patients have been described with multicentric lymph-node hyperplasia associated with various clinical abnormalities. Here a new case of multicentric angiofollicular lymph-node hyperplasia associated with myasthenia gravis and gammopathy is presented. At first, the patient responded to surgery well, but after some months her condition deteriorated: plasmapheresis was then performed, one year after the operation, with great clinical improvement.

Adolescent↗
PubMed2003

Multicentric reticulohistiocytosis presenting with clinical features of dermatomyositis.

Multicentric reticulohistiocytosis (MRH) is a rare disorder with proliferating histiocytes that develop into multinucleated giant cells with "ground-glass" cytoplasm. The disease presents with a rapidly destructive, sometimes permanently debilitating, polyarthritis and a papulonodular eruption, generally of the face and hands. We present 3 cases of MRH in which the initial clinical diagnosis was thought to be dermatomyositis (DM). The cutaneous findings in these cases included an erythematous, predominantly photodistributed macular and papular eruption clinically consistent with DM. However, skin biopsy specimens revealed the diagnosis of MRH. This previously unreported clinical similarity between MRH and DM is significant because the treatment options and future complications vary greatly between the 2 diseases. Thus, it is important to consider the possibility of multicentric reticulohistiocytosis when evaluating a patient with the clinical diagnosis of dermatomyositis.

Adult↗
PubMed2002

Multicentric reticulohistiocytosis. The long course of a rare disease.

Multicentric reticulohistiocytosis is a rare systemic disease. The patients usually develop an erosive polyarthritis in a few years. The most effective treatment is still unclear due to the few reports published of this disease. We report a case of multicentric reticulohistiocytosis with clinical, histopathologic and immunohistochemical study. The patient was treated with cyclophosphamide and nonsteroidal antiinflammatory drugs with an infrequent long-term survival.

Adult↗
PubMed2005

Synchronous multicentric giant cell tumor in a 16-year-old boy.

Synchronous multicentric giant cell tumor of the bone is a rare variant of a lesion appearing during childhood. The authors report clinical, radiological, and pathological features of a 16-year-old boy who was diagnosed with synchronous multicentric giant cell tumor, which originated in the right distal femur and the left fibula.

Adolescent↗
PubMed1996

Inactivation of the IL-6 gene prevents development of multicentric Castleman's disease in C/EBP beta-deficient mice.

Castleman's disease is a lymphoproliferative disorder thought to be related to deregulated production of IL-6. We have previously shown that mice lacking the trans-acting factor C/EBP beta, a transcriptional regulator of IL-6 and a mediator of IL-6 intracellular signaling, develop a pathology nearly identical to multicentric Castleman's disease, together with increasingly high levels of circulating IL-6. We describe here how the simultaneous inactivation of both IL-6 and C/EBP beta genes prevents the development of pathological traits of Castleman's disease observed in C/EBP beta-deficient mice. Histological and phenotypic analysis of lymph nodes and spleen of double mutant mice did not show either the lymphoadenopathy and splenomegaly or the abnormal expansion of myeloid, B and plasma cell compartments observed in C/EBP beta-/- mice, while B cell development, although delayed, was normal. Our data demonstrate that IL-6 is essential for the development of multicentric Castleman's disease in C/EBP beta-/- mice.

Animals↗