Mariette Mercier

Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies—with and without intravascular ultrasound guidance

OBJECTIVES We aimed to investigate the impact of intravascular ultrasound (IVUS)-guided stent implantation on the 6-month restenosis rate, which has not yet been fully established in randomized trials. BACKGROUND The 6-month angiographic restenosis rate was compared in patients with symptomatic ischemic heart disease who were randomly allocated to angioplasty and stent deployment, with versus without IVUS guidance. METHODS After successful stent implantation, patients were randomized into two groups: Group A had no further dilation, and Group B had additional balloon dilation until achievement of IVUS criterion for stent expansion. The study group consisted of 164 patients, assuming a 50% reduction of the restenosis rate in Group B (15% vs. 30%) (alpha = 10%, beta = 20%). RESULTS We enrolled 155 patients. Overdilation was carried out in 31 (39%) of 79 Group B patients, with the IVUS criterion being achieved in 63 (80%) of 79. No significant difference was observed in the minimal luminal diameter (MLD), but the stent lumen cross-sectional area (CSA) was significantly larger in Group B (mean +/- SD) (7.16 +/- 2.48 vs. 7.95 +/- 2.21 mm2, p = 0.04). At 6 months, there was no significant difference in the restenosis rate, (28.8% [21 of 73] in Group A vs. 22.5% [16 of 71] in Group B, p = 0.25), but according to the observed difference in the restenosis rate, the power of the study was only 40%. The difference in MLD was also nonsignificant (1.60 +/- 0.65 mm in Group A vs. 1.70 +/- 0.64 mm in Group B, p = 0.20), whereas the lumen CSA was 20% larger in the IVUS-guided group (4.47 +/- 2.59 vs. 5.36 +/- 2.81 mm2, p = 0.03). Lumen CSA was the only predictor of restenosis by multivariate logistic regression analysis. CONCLUSIONS A nonsignificant 6.3% absolute reduction in the restenosis rate and a nonsignificant difference in MLD were observed in this study. Nonetheless, we still cannot rule out a beneficial effect of IVUS guidance, although this may have gone undetected owing to a lack of statistical power. A significant increase was observed in immediate and 6-month lumen size, as detected by IVUS, indicating that ultrasound guidance in stent deployment may be beneficial.

Preoperative radiochemotherapy in rectal cancer:: Long-term results of a phase II trial☆

PURPOSE To assess toxicity and long-term results of preoperative chemoradiotherapy in rectal cancer. METHODS AND MATERIALS Between 1989 and 1997, as a phase II study, 66 patients with T3 M0, rectal cancer received preoperatively a 45 Gy dose pelvic radiotherapy (XRT) combined with two 5-day chemotherapy courses (CT) of 5-Fluorouracil (5-FU) and Leucovorin (LV) delivered the first and fifth week of XRT. For each CT course, LV:20 mg/m2/d1-d5,. While the 5-FU dose was variable from 450 to 350 mg/m2/d first course and 370 to 350 mg/m2/d second course. Surgery was planned 3 weeks later. RESULTS XRT-CT was stopped in 1 patient due to progressive disease. CT was stopped in 1 patient due to toxicity. Grades 2 and 3 diarrhea were observed in 8 and 3 patients, respectively. One patient died from acute diarrhea due to deviation from recommendations; 60 patients went to surgery. Among the 58 patients operated on for cure, 5 had an R1-resection. After a 4.5-year median follow-up, the 5-year pelvic disease-free survival was 92% for the whole group and 96% in the R0-resection group. CONCLUSION Preoperative combined XRT-5-FU-LV is feasible if optimal XRT and patients are carefully managed. The recommended 5-FU daily dose is 350 mg/m2 for both CT courses. This approach is currently tested in a large EORTC phase III trial.

Quality of Life in rural and urban populations in Lebanon using SF-36 Health Survey

BackgroundMeasuring health status in a population is important for the evaluation of interventions and the prediction of health and social care needs. Quality of life (QoL) studies are an essential complement to medical evaluation but most of the tools available in this area are in English. In order to evaluated QoL in rural and urban areas in Lebanon, the short form 36 health survey (SF-36) was adapted into Arabic.MethodsSF-36 was administered in a cross-sectional study, to collect sociodemographic and environmental variables as well as self reported morbidity. We analysed a representative sample containing 1632 subjects, from whom we randomly picked 524 subjects aged 14 years and over. The translation, cultural adaptation and validation of the SF-36 followed the International Quality of Life Assessment methodology. Multivariate analysis (generalized linear model) was performed to test the effect of habitat (rural on urban areas) on all domains of the SF-36.ResultsThe rate of missing data is very low (0.23% of items). Item level validation supported the assumptions underlying Likert scoring. SF-36 scale scores showed wide variability and acceptable internal consistency (Cronbachs alpha >0.70), factor analysis yielded patterns of factor correlation comparable to that found in the U.S.A and France. Patients resident in rural areas had higher vitality scores than those in urban areas. Older people reported more satisfaction with some domains of life than younger people, except for physical functioning. The QoL of women is poorer than men; certain symptoms and morbidity independently influence the domains of SF-36 in this population.ConclusionThe results support the validity of the SF-36 Arabic version. Habitat has a minor influence on QoL, women had a poor QoL, and health problems had differential impact on QoL.

Comparison of the Nottingham Health Profile and the 36-item health survey questionnaires in cardiac surgery

BACKGROUND Quality of life (QOL) instruments help to integrate the patients view into clinical practice and into the evaluation of new therapeutic strategies. The aim of the present study was to determine which of two generic QOL instruments, the Nottingham Health Profile (NHP) or the Short Form Health Survey (SF36), was the more suitable for use in cardiac surgery. METHODS The NHP and the SF36 were compared before and 5 weeks after surgery. Comparison was conducted in two stages: (1) the acceptability and psychometric properties of the tools were measured, and (2) the short-time evolution of angina pectoris and dyspnea status were assessed with the QOL. RESULTS A total of 322 patients were included and 299 patients completed preoperative and postoperative questionnaires. Acceptability was similar for both questionnaires. Internal consistency, ceiling effect, sensitivity to change, as well as the assessment of the evolution of angina pectoris and dyspnea were better for the SF36 than for the NHP. CONCLUSIONS The SF36 seems more suitable than the NHP for evaluating QOL in cardiac surgery.

Quality of life in long-term cervical cancer survivors: A population-based study

OBJECTIVES To assess long-term quality of life (QOL) in cervical cancer survivors (CCSs), 5, 10, and 15 years after diagnosis. METHODS In a cross-sectional population-based study, CCSs diagnosed in 1990, 1995, or 2000 were randomly selected from 3 tumor registries in France. Healthy controls were randomly selected from electoral rolls, stratifying on age group and residence area. Five QOL questionnaires (SF-36, EORTC QLQ-C30, the cervical cancer-specific module (EORTC QLQ-CX24), the MFI fatigue questionnaire, the STAI for anxiety) and a life condition questionnaire were used. Analysis of variance was used to compare QOL scores of survivors by period of diagnosis (5, 10, and 15 years) with those of controls and according to treatment modality, adjusted for socio-demographic data. RESULTS A total of 173 localized CCSs (42% treated with surgery alone and 58% with a combination of treatments) and 594 controls participated in the study. Compared with controls, CCSs expressed globally similar good QOL, except for impaired psychoemotional domains in 15-year survivors (p<0.01). Worsening of some symptoms was observed over time, 15-year survivors in particular reported significantly more lymphedema than 5-year (p=0.0009) and 10-year CCSs (p=0.002). Compared with CCSs treated by surgery alone, QOL of CCSs who received radiotherapy was significantly more affected in terms of cervical cancer specific problems, such as sexual dysfunction (p=0.002), voiding and abdominal symptoms (p=0.01), and lymphedema (p=0.01). CONCLUSIONS Even after 15 years, QOL of CCSs is impacted in psychological domains, compared with healthy controls. Among CCSs, women treated by adjuvant radiotherapy expressed more physical sequelae.

Response shift effects on measuring post-operative quality of life among breast cancer patients: a multicenter cohort study

PurposeTo characterize response shift effects in patients with breast cancer (BC).MethodsThe QLQ-C30, BR23, and EurQOL-EQ-5D were assessed at baseline and at the end of the first hospitalization. We used the then-test approach to characterize changes in internal standards by calculating the mean difference between the then-test (retrospective measure) and pre-test baseline QoL assessments. The Ideal Scale Approach was also used to assess changes in standards by comparing health and QoL expectancies between baseline and the end of the first hospitalization. Successive Comparison Approach was used to assess changes in values through the longitudinal assessment of the relative importance of EuroQOL dimensions.ResultsThe results of this study showed that recalibration RS effects occurred early after the first hospitalization for 6/15 dimensions of QLQ-C30 (emotional, cognitive, fatigue, insomnia, appetite loss, diarrhea) and 2/8 of BR-23 (future perspective, systemic therapy side effects). Moreover, health and QoL expectancies changed between the baseline and the end of the first hospitalization, and changes in values were seen for the self-care and usual activities dimensions of the EuroQOL-EQ-5D.ConclusionsThe occurrence of RS early after the first hospitalization suggests that it needs to be taken into account to interpret QoL changes in BC.

Health-Related Quality of Life Among Long-Term Survivors of Colorectal Cancer: A Population-Based Study

BACKGROUND The number of long-term colorectal cancer survivors is increasing. Cancer and its treatment can cause physical and psychological complications, but little is known about how it impacts quality of life (QOL) over the long term-5, 10, and 15 years after diagnosis. METHODS Cancer survivors were randomly selected from three tumor registries in France, diagnosed in 1990 (±1 year), 1995 (±1 year), and 2000 (±1 year). Controls were randomly selected from electoral rolls, stratifying on gender, age group, and residence area. Participants completed two QOL questionnaires, a fatigue questionnaire, an anxiety questionnaire, and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of cancer survivors by period of diagnosis (5, 10, and 15 years) with those of controls, adjusted for sociodemographic data and comorbidities. RESULTS We included 344 colon cancer and 198 rectal cancer survivors and 1,181 controls. In a global analysis, survivors reported a statistically and clinically significant lower score in social functioning 5 years after diagnosis and higher scores in diarrhea symptoms 5 and 10 years after diagnosis. In subgroup analyses, rectal cancer affected QOL in the physical dimensions at 5 years and in the fatigue dimensions at 5 and 10 years. CONCLUSION Survivors of colorectal cancer may experience the effects of cancer and its treatment up to 10 years after diagnosis, particularly for rectal cancer. Clinicians, psychologists, and social workers must pay special attention to rectal cancer survivors to improve overall management.

Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment.

Purpose The optimal treatment duration for ventilator-associated pneumonia is based on one study dealing with late-onset of the condition. Shortening the length of antibiotic treatment remains a major prevention factor for the emergence of multiresistant bacteria. Objective To demonstrate that 2 different antibiotic treatment durations (8 versus 15 days) are equivalent in terms of clinical cure for early-onset ventilator-associated pneumonia. Methods Randomized, prospective, open, multicenter trial carried out from 1998 to 2002. Measurements The primary endpoint was the clinical cure rate at day 21. The mortality rate was evaluated on days 21 and 90. Results 225 patients were included in 13 centers. 191 (84.9%) patients were cured: 92 out of 109 (84.4%) in the 15 day cohort and 99 out of 116 (85.3%) in the 8 day cohort (difference = 0.9%, odds ratio = 0.929). 95% two-sided confidence intervals for difference and odds ratio were [−8.4% to 10.3%] and [0.448 to 1.928] respectively. Taking into account the limits of equivalence (10% for difference and 2.25 for odds ratio), the objective of demonstrative equivalence between the 2 treatment durations was fulfilled. Although the rate of secondary infection was greater in the 8 day than the 15 day cohort, the number of days of antibiotic treatment remained lower in the 8 day cohort. There was no difference in mortality rate between the 2 groups on days 21 and 90. Conclusion Our results suggest that an 8-day course of antibiotic therapy is safe for early-onset ventilator-associated pneumonia in intubated patients. Trial Registration ClinicalTrials.gov NCT01559753

Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer

BackgroundThe aim of this study was to compare the responsiveness of the European Organization for Research and Treatment (EORTC) quality of life questionnaires (QLQ-C30, QLQ-CR38) and the Functional Assessment of Cancer Therapy-colorectal version 4 questionnaire (FACT-C).MethodThis prospective study included 127 patients with colorectal cancer: 71 undergoing chemotherapy and 56 radiation therapy. Responsiveness statistics included the Standardized Response Mean (SRM) and the Effect Size (ES). The patients overall assessment of his/her change in state of health status was the reference criterion to evaluate the responsiveness of the QoL questionnaires.Results34 patients perceived their health as stable and 17 as improved between the first and the fourth courses of chemotherapy. 21 patients perceived their health as stable and 22 as improved between before and the last week of radiotherapy.The responsiveness of the 3 questionnaires differed according to treatments. The EORTC QLQ-C30 questionnaire was more responsive in patients receiving chemotherapy, particulary functional scales (SRM > 0.55). The QLQ-CR38 and the FACT-C questionnaires provided little clinically relevant information during chemotherapy or radiotherapy.ConclusionThe EORTC QLQ-C30 questionnaire appears to be more responsive in patients receiving chemotherapy.

Antibodies against Echinococcus multilocularis alkaline phosphatase as markers for the specific diagnosis and the serological monitoring of Alveolar echinococcosis

The immunological properties of the purified alkaline phosphatase (pAP) of Echinococcus multilocularis metacestodes have been investigated using alveolar echinococcosis (AE) patient sera in ELISA tests. A comparative study was done with EmC‐Ag (crude antigen) and pAP‐Ag (purified antigen). When the parasite purified enzyme pAP was used as antigen, the specificity of the ELISA was markedly increased since it reached 100% without any decrease of its sensitivity (100%). The serologic follow‐up of AE patients was conducted during several months with these two antigens in three categories of patients: cured, stabilized and aggravated. There was a good correlation between clinical and serologic data when the pAP was used as antigen in ELISA tests. The anti‐pAP antibodies titres did change more rapidly than anti‐EmC antibodies titres when a recurrence occurred. Modifications of the anti‐pAP antibodies levels were also observed during the patient’s therapy: mebendazole, albendazole and Isoprinosine®. These results suggest that pAP‐Ag should be used for the diagnosis and the follow‐up of AE patients.