Routine ultrasonography in melanoma follow-up?
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Biopsy↗
Biomedical subjects
Bruno Giraudeau
Publications and source records attributed to Bruno Giraudeau.
Predictive factors for fibroids recurrence after uterine artery embolisation.
OBJECTIVES: To assess clinical failure and symptom recurrence after uterine artery embolisation (UAE) and to define predictive factors. DESIGN: Prospective study of a case series. SETTING: Gynaecology and radiology departments of a French University Hospital. POPULATION: Eighty-five women who underwent embolisation for the treatment of uterine fibroids. METHOD: Vascular access was obtained via the right common femoral artery. Free-flow embolisation was performed using 150-250 mum polyvinyl alcohol particles and an absorbable particle sponge. MAIN OUTCOME MEASURES: Clinical failure was defined as persistence of symptoms at three months of follow up and recurrence as return of symptoms. The main outcome measure was the need for further treatment after UAE. RESULTS: Results are available for 81 patients. Median follow up was 30 months. There were 15 clinical failures and recurrences requiring further treatment (eight hysterectomies, five hysteroscopic resections for submucous fibroids, one second embolisation and one woman refusing further treatment). Recurrence-free survival rate at 30 months (no clinical failure, no recurrence) was 82.8% (95% CI 73.7-91.8%). Multivariate analysis identified two predictive factors: dominant fibroid size on ultrasound imaging (each 1 cm increase: HR = 1.68, 95% CI 1.10-2.69) and number of fibroids (each additional fibroid: HR = 1.34, 95% CI 1.08-1.66). CONCLUSIONS: Symptom recurrence rate 30 months after fibroid embolisation was 17.2%. Fibroid size and number were predictive factors for recurrence. As most recurrences occurred after two years, we recommend that patients be monitored clinically and that imaging be for more than two years after UAE.
Adult↗
Does data rounding-off influence reproducibility index estimates?
The intraclass correlation coefficient (ICC) is the reproducibility index commonly used to assess the reproducibility level of continuous data. Such data are collected with finite precision (i.e., a finite number of decimal digits corresponding to the level of data rounding-off error). We therefore investigated the consequences of having finite precision for data on ICC estimates, thus comparing ICC estimates in presence of rounding-off to those associated with data with infinite precision. As long as the rounding-off level is less than 0.3sigmaX (where sigmaX is the standard deviation of the outcome measured), there is no practical consequence on the ICC estimate. Therefore, in most practical situations the consequences of rounding-off data on the estimation of reproducibility levels can be ignored.
Data Collection↗
Disposal of injection material used for the treatment of hepatitis C: comparison with insulin-dependent diabetes and thromboembolism.
AIM: The survey conducted in the Provence-Alpes-Cote d'Azur region in France in 1999 showed that 38% of patients infected with the hepatitis C virus (HCV) receiving interferon injections in their home were aware of the recommendations concerning the disposal of injection material and that 41% of the needles were discarded with household waste after use. The purpose of our study conducted in the Centre region of France was to ascertain how injection material used by HCV-positive patients for interferon treatment are disposed of in comparison with material used by patients injecting insulin for insulin-dependent diabetes mellitus (IDDM) or low-molecular-weight heparin (LMWH) for thromboembolism. MATERIAL AND METHODS: A questionnaire to be completed by patients was proposed to HCV-positive patients attending hepatogastroenterology clinics in the Centre region hepatitis C network for therapeutic follow-up (N=113 patients) between October 2001-January 2002. The same questionnaire was proposed to patients attending follow-up consultations for insulin-dependent diabetes mellitus (N=85 patients) or thromboembolism (N=23 patients) between March-June 2002. RESULTS: Significantly more patients stated they were aware of recommendations for disposal of injection material in the HCV group (89%) than in the IDDM (67%) or LMWH (26%) groups (P<0.01). Injection material was discarded with household waste less often by patients in the HCV group (6%) than in the IDDM (32%) or LMWH (29%) groups (P<0.001) and more often collected in a safety box prior to incineration (73% in the HCV group versus 63% and 14% in the IDDM and LMWH groups respectively). The safety box was discarded with household garbage more often by patients in the IDDM (54%) or LMWH (50%) groups than in the HCV group (0%) (P<0.001). Equivalent proportions of the patients said they recapped the needle after use (HCV 83%; IDDM 93%; LMWH 84%). DISCUSSION: Information concerning use of safety boxes for disposal of injection material should be provided to patients in order to comply with regulatory recommendations on proper disposal of used injection material. Moreover, the habit of recapping needles (89% of all patients in this study) is still widespread.
Adolescent↗
Ovine model to evaluate ovarian vascularization by using contrast-enhanced sonography.
This project was designed to evaluate an ovine model for the use of contrast agent to visualize the microcirculation of normal ovaries. Intraovarian vascularization was investigated in eight ewes by using contrast-enhanced power Doppler after intravenous injection of Sonovue at five different times during each of ten normal estrous cycles. Sheep under general anesthesia underwent transvaginal B mode and power Doppler ultrasound examination of both ovaries, then received two successive doses of 5 ml of Sonovue, one dose for each ovary. Each ovary was monitored after the contrast injection, and a 3-min video clip was stored for each side. The video clip was used to derive time-intensity curves, which were then used to derive the contrast parameters. A total of 108 doses of contrast agent were used; 93% of the injections were available for contrast enhancement analysis. The optimal dose was determined on the first two sheep. Enhancement was strongest and longest with the 5-ml dose. In one sheep, enhancement of both ovaries remained weak irrespective of the period of the cycle. No adverse side effects of Sonovue were seen in the sheep. Contrast injection improved visualization of ovarian microcirculation by 248% (95% confidence interval [CI], 210 to 285%) for 74.2 sec (95% CI, 68.2 to 80.2 sec). Ovaries on the side of ovulation had a stronger enhancement compared with the ovary with no ovulation (368% versus 175%, P < 0.001), but the enhancement time was the same. We concluded that the sheep is an excellent animal model to illustrate microcirculation enhancement by using Sonovue to demonstrate ovarian vascular changes.
Animals↗
Safety study of intraarticular injection of interleukin 1 receptor antagonist in patients with painful knee osteoarthritis: a multicenter study.
OBJECTIVE: Interleukin 1 (IL-1) plays a pivotal role in the pathogenesis of osteoarthritis (OA). In animal models of OA, IL-1 blockade by IL-1 receptor antagonist (IL-1Ra) can slow the progression of disease. We examined the safety of intraarticular (IA) injections of recombinant human IL-1Ra in patients with knee OA. METHODS: A prospective multicenter trial was conducted using the continual reassessment method. Six doses were considered, 0.05 mg up to 150 mg IL-1Ra, and the trial was double-blind regarding the dose administered. Patients with symptomatic knee OA and without synovial fluid effusion were included. Acute inflammatory reaction (the primary endpoint defining intolerance) was recorded if pain increase over 30 mm on 100 mm visual analog scale and synovial fluid effusion occurred within 72 h after the IA injection. As a secondary aim, efficacy was estimated (by total pain and Western Ontario and McMaster University OA functional index) until Month 3. RESULTS: One patient received 0.05 mg and 13 patients received 150 mg of IL-1Ra. No acute reaction occurred (one patient experienced postinjection joint swelling with no pain) and the 150 mg dose was considered the maximum tolerated dose (intolerance level 0%; confidence interval 0, 9.1%). A significant improvement was still observed until Month 3 in the 13 patients who received 150 mg IL-1Ra: pain improved by -20.4 +/- 23.3 mm (p = 0.008) and WOMAC global score by -19.5 +/- 20.1 (p = 0.005). CONCLUSION: IA injection of IL-1Ra in patients with knee OA was well tolerated and did not induce any acute inflammatory reaction. The feasibility of such IA injections of IL-1Ra opens a promising therapeutic perspective for patients with OA.
Aged↗
A retrospective multicentre study comparing myomectomy by laparoscopy and laparotomy in current surgical practice. What are the best patient selection criteria?
OBJECTIVE: To determine the differences in myoma characteristics before laparoscopic myomectomy (LM) and abdominal myomectomy (AM) and to compare outcomes in current practice. STUDY DESIGN: We analysed retrospectively the data for 126 LMs and 176 AMs performed between January 1996 and January 2000 in 11 centres. Myomas were examined by transvaginal B-mode, colour and pulsed energy Doppler ultrasonography. The following data were collated: (i) pre-operative: myoma size, number, type and location and medical treatment, (ii) per-operative: operator, blood loss, surgical procedure and operative time, and (iii) post-operative: myoma weight and number, haemoglobin decrease, complications and length of hospital stay. RESULTS: Compared to women undergoing LM, women undergoing AM had more myomas that were larger and that were generally interstitial and anterior. More of them received GnRH analogues. Excised myomas weighed four times more, the decrease in haemoglobin was greater (1g/dl), fever was more frequent, and nine patients needed transfusions (compared to none for LM). There were 37 laparoconversions (29%) after LM. The conversion rate was high for inexperienced surgeons. Length of hospital stay was reduced by half for LM (without laparoconversion). Recurrence rate at 2 years was 2.5% for LM versus 3.6% for AM (P = 0.506). CONCLUSION: Pre-operative evaluation by ultrasound is essential to establish myoma number, size, type and location in order to choose the most appropriate surgical procedure.
Female↗
The efficiency of transfusing high doses of platelets in hematologic patients with thrombocytopenia: results of a prospective, randomized, open, blinded end point (PROBE) study.
We performed a prospective, randomized, open, blinded end point (PROBE) study to assess the efficiency of transfusing high doses of platelets in patients with thrombocytopenia, either acute leukemia (AL) or those undergoing autologous hematopoietic stem cell transplantation (AT). Patients were randomly assigned to receive transfusions with a target dose of 0.5 x 10(11)/10 kg (arm A) or 1 x 10(11)/10 kg (arm B). A total of 101 patients were included, of whom 96 were given at least one transfusion. The median time between the first transfusion and when the platelet count reached at least 20 x 10(9)/L increased from 63 hours to 95 hours in the arm B group (P = .001), and the median number of transfusions was lower in this group (2; P = .037). The total number of transfused platelets did not differ between groups (14.9 x 10(11) for arm A versus 18.5 x 10(11) for arm B; P = .156). In such patients, a prophylactic strategy of high doses of platelets could improve platelet transfusion efficiency.
Adult↗
The methods for handling missing data in clinical trials influence sample size requirements.
OBJECTIVE: Results of studies estimating osteoarthritis progression may be affected by missing values. In clinical trials assessing disease-modifying osteoarthritis drugs, sample sizes should be calculated using close estimates of outcome variables. STUDY DESIGN AND SETTING: Supposing a two-parallel group design in hip osteoarthritis clinical trials, we estimated sample sizes using the joint space width (JSW), number of patients with JSW progression >0.5 mm (JSN), time to total hip arthroplasty (THA), and time to JSN or THA using several approaches to deal with missing data. RESULTS: Three-year clinical trials testing a treatment effect of 50%, with a power of 80%, could require sample sizes of 121 patients for JSW, 57 for JS progression using multiple imputation for handling missing values; 200 for THA; and 47 for JSN or THA. These numbers vary greatly depending on the approach chosen for handling missing data. CONCLUSIONS: These results can help investigators plan clinical trials to select the primary outcome and a priori specify the way missing data will be handled.
Aged↗
Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials.
OBJECTIVE: To compare the feasibility of blinding and the perceived risk of unblinding in trials evaluating pharmacologic (PT) and nonpharmacologic treatments (NPT) of hip or knee osteoarthritis. STUDY DESIGN AND SETTING: Two independent reviewers assessed the feasibility of blinding patients, care providers, and outcome assessors, the perceived risk of unblinding, and whether blinding was reported in 110 reports of randomized controlled trials (RCTs) evaluating PT and NPT in patients with hip or knee osteoarthritis. RESULTS: Blinding was considered to be possible less often in NPT trials than in PT trials for patients (42 vs. 96%; P <.001), care providers (12 vs. 96%; P <.001), and outcome assessors (34 vs. 98%; P <.001). When blinding was judged feasible, the perceived risk of unblinding was more often considered moderate or important in NPT than PT trials for patients (35 vs. 14%, P=.02) and outcome assessors (44 vs. 10%, P=.0004). When blinding was judged feasible, it was reported less often in NPT reports than in PT reports for patients (46 vs. 98%, P <.001), care providers (43 vs. 83%, P=.03), and outcome assessors (72 vs. 98%, P=.0006). CONCLUSION: Blinding appears to be more difficult to achieve and unblinding may occur more often in NPT than PT trials.
Double-Blind Method↗
[The cluster-randomized trial].
Within the framework of a clinical trial, one is sometimes brought to randomize groups of subjects rather than the subjects themselves. This type of experimental design has methodological consequences of importance (in particular biostatistical consequences) and can limit the extrapolation of the results. A cluster randomized trial is thus justified only if the context or the question of interest imposes it and biostatistical issues have then to be handled in a rigorous way.
Biometry↗
Association of donor TNFRSF6 (FAS) gene polymorphism with acute rejection in renal transplant patients: a case-control study.
BACKGROUND: Genetic factors other than HLA have been reported to be associated with the outcome of organ transplantations. Because binding of FasL to its receptor Fas could play an important role in tubulitis and in the death of graft tubular epithelial cells during kidney allograft rejection, a gene polymorphism recently identified in position -671 in the promoter of the TNFRSF6 gene coding for Fas was investigated in donors. METHODS: A case-control study was performed within a cohort of non-hyperimmunized adult patients who had received cadaveric kidney transplants based on the occurrence or absence of acute cellular rejection in the first 6 months after renal transplantation. Each recipient from the acute rejection group (n = 35) was matched for age (+/- 5 years) and number of HLA-DR mismatches with two recipients within the non-acute rejection group (n = 70). RESULTS: The TNFRSF6-GG genotype was more frequent in donors in the group without rejection episodes. In contrast, patients who received a kidney from a TNFRSF6-A carrier were more likely to experience acute rejection episodes (relative risk nearly 2.1). CONCLUSION: This study suggests that donor TNFRSF6 polymorphism directly or indirectly influences acute kidney rejection episodes.
Adult↗
Living with a functioning kidney transplant at 74 yr or older: a national epidemiological study.
The number of older patients living with a functioning kidney graft is increasing. However the safety of the immunosuppressive treatment and quality of life in this population have not yet been determined. All patients grafted in France since 1969, born before the January 1 1926 and living with a functioning graft on January 1 2000 were included in this national study including all 34 French transplant centers. Renal function, immunosuppressive treatment, comorbid conditions and quality of life were assessed. From the initial population of 446 patients, 113 (26.2%) were still alive in 2000 (study population). Mean age was 76 yr (range: 74-80) with a mean post-transplant follow-up of 9.9 yr (0.1-28.7). Average serum creatinine level was 129 micromol/L (55-286). Immunosuppression was heterogeneous and included triple therapy (18.6%), dual therapy (41.6%) and monotherapy (40.8%). A history of cancer was noted in 36 of the 113 patients (32.1%) whereas hypertension was the most frequent co-morbid condition (80.3%). Estimated quality of life using the Karnofsky scale was between 80 and 100 in 78.4% of the patients. The immunosuppressive regimen in older renal transplant recipients living with a functioning graft varied widely among the 34 French transplant centers. Renal function in this group of patients was good and quality of life seemed excellent. Cardiovascular disease and malignancies were the main co-morbid conditions.
Aged↗
Contrast-enhanced sonography helps in discrimination of benign from malignant adnexal masses.
OBJECTIVE: To investigate the potential efficacy of real-time contrast-enhanced power Doppler sonography in the differentiation of benign and malignant adnexal masses in a pilot study. METHODS: Before surgical treatment, adnexal masses were prospectively evaluated with power Doppler sonography before and after injection of a contrast agent. Real-time postinjection sequences were computerized with time-intensity analysis software to determine an enhancement curve and contrast parameters. The intraobserver and interobserver reproducibilities of these criteria were assessed on a subsample. These contrast parameters were compared between benign and malignant tumors using logistic regression. Sensitivity and specificity were used to compare contrast parameters with sonographic and Doppler variables. RESULTS: Ninety-nine women were included, for a total of 101 adnexal masses. There were 23 cases of ovarian malignancies and 78 benign adnexal lesions. Our procedure had excellent intraobserver and interobserver reproducibility, with an average intraclass correlation coefficient of 0.92. The time before enhancement and intensity ratio did not reliably differentiate between the benign and malignant masses. Washout times and areas under the curves were significantly greater in ovarian malignancies than in other benign tumors (P < .001), leading to sensitivity estimates between 96% and 100% and specificity estimates between 83 and 98%. Contrast parameters had slightly higher sensitivity and slightly lower specificity when compared with transvaginal sonographic variables of the resistive index and serum cancer antigen 125 levels. CONCLUSIONS: Contrast-enhanced power Doppler imaging may easily and precisely discriminate benign from malignant adnexal lesions. Larger studies are needed to determine the appropriate use and benefits of this new procedure.
Adnexal Diseases↗
Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis.
CONTEXT: Randomized controlled trials have been developed essentially in the context of pharmacological treatments (ie, oral drugs; intra-articular injection; and topical, intramuscular, and intravenous treatments), but assessment of the effectiveness of nonpharmacological treatments (ie, surgery, arthroscopy, joint lavage, rehabilitation, acupuncture, and education) presents specific issues. OBJECTIVES: To compare the quality of articles of nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific methodological issues related to assessment of nonpharmacological treatments. DESIGN AND SETTING: We searched MEDLINE and the Cochrane Central Register of Controlled Trials for articles of randomized controlled trials published between January 1, 1992, and February 28, 2002, in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis. MAIN OUTCOME MEASURES: The quality of the methods reported in the selected articles was assessed by 2 independent reviewers using the Jadad scale, the Delphi list, and guidelines found in the Users' Guides to the Medical Literature. Investigators also used a checklist of items developed by the authors to analyze study characteristics. RESULTS: A total of 110 articles were included in the analysis; 50 (45.5%) assessed nonpharmacological treatments and 60 (54.5%) assessed pharmacological treatments. Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale (mean [SD] score, 1.4 [1.3] vs 3.0 [1.3]) and the Delphi list (mean [SD] score, 5.2 [1.5] vs 7.5 [1.1]). Lack of reporting adequate random sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles. Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments (28.0% of articles vs 71.7%). Compared with pharmacological articles, nonpharmacological articles less often described blinding of patients (26.0% vs 96.7%), care providers (6.0% vs 81.7%), and outcome assessors (68.0% vs 98.3%). Care providers' skill levels could influence treatment effect in 84.0% of nonpharmacological articles vs 23.3% of pharmacological articles. CONCLUSIONS: In this analysis of reports of hip and knee osteoarthritis therapy, nonpharmacological articles scored lower than pharmacological articles in terms of quality. Assessments of nonpharmacological treatments must take into consideration additional methodological issues.
Complementary Therapies↗
Conjugated linoleic acid content in breast adipose tissue of breast cancer patients and the risk of metastasis.
The association between the level of conjugated linoleic acid (CLA) in breast adipose tissue at the time of diagnosis and the subsequent development of metastasis was examined in a cohort of 209 patients presenting with an initially localized breast cancer. CLA level in breast adipose tissue was used as a qualitative biomarker of its past dietary intake. Biopsies of adipose tissue were obtained at the time of initial surgery. A CLA-enriched fraction was prepared by high performance liquid chromatography and CLA measured as a percentage of total fatty acids, using capillary gas chromatography. Mean CLA level was low (0.44% of total fatty acids) and the range between patients was narrow (0.19-0.85). With a median follow-up time of 7.5 yr, 45 patients developed metastases. A Cox proportional hazard regression model was used to identify prognostic factors. We did not find any significant association between CLA level in adipose fat and either the prognostic factor (tumor size, nodal status, histoprognostic grade, mitotic index, and estrogen or progesterone receptors) or the risk of metastasis or death. We concluded that CLA are unlikely to be involved in survivorship. However, the hypothesis that a higher intake of CLA might have a protective effect on the risk of metastasis cannot be ruled out from these data, since the level of CLA in breast cancer patients' adipose tissue is likely to be too low and the range of CLA distribution too narrow for any protection to be detectable.
Adipose Tissue↗
Quantification of dopamine transporter by 123I-PE2I SPECT and the noninvasive Logan graphical method in Parkinson's disease.
UNLABELLED: (E)-N-(3-iodoprop-2-enyl)-2beta-carbomethoxy-3beta-(4'-methyl-phenyl) nortropane (PE2I), a cocaine analog, is a new, highly specific tracer for imaging dopamine transporter labeled with (123)I for in vivo SPECT. Its reversible binding on dopamine transporter and its rapid kinetics allow quantification of its binding potential according to a 3-compartment model. For quantification of distribution volume of reversible tracer, Logan developed a noninvasive and graphical method that allows accurate estimation of binding potential. In this study, we performed (123)I-PE2I SPECT on healthy volunteers and patients with Parkinson's disease (PD) to validate the Logan graphical method for quantification of (123)I-PE2I binding and to analyze the relationship between (123)I-PE2I SPECT and clinical features of this frequent degenerative disease. METHODS: Eight PD patients (3 women, 5 men; mean age, 64 +/- 7.9 y; disease duration range, 1-8 y, Hoehn and Yahr stage range, 1-2.5) and 8 age-matched healthy volunteers (4 women, 4 men; mean age, 61.5 +/- 9.5 y) were included in 2 centers and studied with SPECT. Four sequential SPECT imaging sessions of 15-min duration were performed from 5 to 65 min after bolus injection of 140 +/- 30 MBq of (123)I-PE2I. RESULTS: The kinetics of PE2I in healthy volunteers and PD patients were rapid, and the Logan graphical method allowed quantification of distribution volume ratio (DVR) in the caudate nucleus and putamen. (123)I-PE2I striatal specific binding was significantly reduced in PD patients, compared with healthy volunteers, in the caudate and putamen. The decrease of DVR in the putamen was significantly and inversely correlated to disease duration and Hoehn and Yahr stage. In asymmetric PD patients, (123)I-PE2I uptake was significantly more reduced in the putamen contralateral to the side with predominant clinical symptoms. However, (123)I-PE2I uptake was also significantly reduced in the ipsilateral putamen, compared with that in healthy volunteers, suggesting that (123)I-PE2I SPECT can detect nigrostriatal degeneration before the appearance of clinical symptoms. CONCLUSION: Our data indicate that the Logan graphical method is accurate for noninvasive quantification of PE2I and that (123)I-PE2I SPECT is a useful quantitative method for accurate estimation of nigrostriatal dopaminergic nerve terminal degeneration. The close relationships between SPECT findings and clinical data suggest that this method is useful for objectively following the progression of PD and for assessing the effect of potential neuroprotective treatments. Finally, our findings suggest that (123)I-PE2I SPECT can be used for preclinical and early diagnosis of PD.
Aged↗